Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
þ |
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934. |
For the fiscal year ended December 31, 2008
or
|
|
|
o |
|
TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934. |
Commission File Number: 0-24006
NEKTAR THERAPEUTICS
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
|
94-3134940 |
(State or other jurisdiction of
incorporation or organization)
|
|
(IRS Employer
Identification No.) |
201 Industrial Road
San Carlos, California 94070
(Address of principal executive offices and zip code)
650-631-3100
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
Title of Each Class
|
|
Name of Each Exchange on Which Registered |
|
|
|
Common Stock, $0.0001 par value
|
|
NASDAQ Global Select Market |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule
405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or Section 15(d) of the Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days) Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrants
knowledge, in definitive proxy or information statements incorporated by reference in Part III of
this Form 10-K or any amendment to this Form 10-K. þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer þ
|
|
Non-accelerated filer o
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act
Rule 12b-2) Yes o No þ
The approximate aggregate market value of voting stock held by non-affiliates of the
registrant, based upon the last sale price of the registrants common stock on the last business
day of the registrants most recently completed second fiscal quarter, June 30, 2008 (based upon
the closing sale price of the registrants common stock listed as reported on the NASDAQ Global
Select Market), was approximately $300,233,348. This calculation excludes approximately 2,792,787
shares held by directors and executive officers of the registrant. Exclusion of these shares does
not constitute a determination that each such person is an affiliate of the registrant.
As of February 27, 2009, the number of outstanding shares of the registrants common stock was
92,506,054.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of registrants definitive Proxy Statement to be filed for its 2009 Annual Meeting of
Stockholders are incorporated by reference into Part III hereof. Such Proxy Statement will be filed
with the Securities and Exchange Commission within 120 days of the end of the fiscal year covered
by this Annual Report on Form 10-K.
NEKTAR THERAPEUTICS
2008 ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
2
Forward-Looking Statements
This report includes forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities
Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of
historical fact are forward-looking statements for purposes of this annual report on Form 10-K,
including any projections of earnings, revenue or other financial items, any statements of the
plans and objectives of management for future operations (including, but not limited to,
pre-clinical development, clinical trials and manufacturing), any statements concerning proposed
drug candidates or other new products or services, any statements regarding future economic
conditions or performance and any statements of assumptions underlying any of the foregoing. In
some cases, forward-looking statements can be identified by the use of terminology such as may,
will, expects, plans, anticipates, estimates, potential or continue, or the negative
thereof or other comparable terminology. Although we believe that the expectations reflected in the
forward-looking statements contained herein are reasonable, such expectations or any of the
forward-looking statements may prove to be incorrect and actual results could differ materially
from those projected or assumed in the forward-looking statements. Our future financial condition
and results of operations, as well as any forward-looking statements, are subject to inherent risks
and uncertainties, including, but not limited to, the risk factors set forth in Part I, Item 1A
Risk Factors below and for the reasons described elsewhere in this annual report on Form 10-K.
All forward-looking statements and reasons why results may differ included in this report are made
as of the date hereof and we do not intend to update any forward-looking statements except as
required by law or applicable regulations.
Except where the context otherwise requires, in this annual report of Form 10-K, the
Company, Nektar, we, us, and our refer to Nektar Therapeutics, a Delaware corporation,
and, where appropriate, its subsidiaries.
Trademarks
The Nektar brand and product names, including but not limited to Nektar®, contained
in this document are trademarks, registered trademarks or service marks of Nektar Therapeutics in
the United States (U.S.) and certain other countries. This document also contains references to
trademarks and service marks of other companies that are the property of their respective owners.
3
PART I
Item 1. Business
We are a clinical-stage biopharmaceutical company developing a pipeline of drug candidates
that utilize our PEGylation and advanced polymer conjugate technology platforms, which are designed
to improve the benefits of drugs for patients. Our current proprietary product pipeline is
comprised of drug candidates across a number of therapeutic areas including oncology, pain,
anti-infectives, anti-viral and immunology. Our research and development activities involve small
molecule drugs, peptides and other potential biologic drug candidates. We create our innovative
drug candidates by using our proprietary chemistry platform to modify the chemical structure of
drugs using unique polymer conjugates. Polymer chemistry is a science focused on the synthesis or
bonding of polymer architectures with drug molecules to alter the properties of the molecule when
it is bonded with our proprietary polymers. Additionally, we may utilize established pharmacologic
targets to engineer a new drug candidate relying on a combination of the known properties of these
targets and our polymer chemistry technology and expertise. Our drug candidates are designed to
improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or
distribution of drugs and improve the overall benefits and use of a drug for the patient. Our
objective is to apply our advanced polymer conjugate technology platform to create new drugs in
multiple therapeutic areas.
Each of our drug candidates which we are currently developing internally is a proprietary new
chemical or biological entity that addresses large potential markets. We are developing drug
candidates that can be delivered by oral or subcutaneous administration. Our most advanced
proprietary product candidate, Oral NKTR-118, is a peripheral opioid antagonist that is currently
being evaluated for the treatment of opioid-induced constipation (OIC) and we recently announced
that we were terminating our Phase 2 clinical trial for this program due to positive preliminary
results. Our other lead product candidate, NKTR-102, is a cytotoxic topoisomerase I inhibitor
that is being evaluated or will be evaluated in four separate Phase 2 clinical trials for the
treatment of multiple cancers, including ovarian, breast, cervical and colorectal.
In addition to our internal pipeline, we have a number of collaborations and license
agreements for our technology with leading biotechnology and pharmaceutical companies, including
Amgen, Schering-Plough, Baxter, UCB and Roche. A total of nine products using our PEGylation
technology platform have received regulatory approval in the U.S. or Europe, and are currently
marketed by our partners. There are also a number of other products in clinical development that
use our technology platform. These licensing collaborations will represent the majority of our
revenue stream in 2009 which will be comprised of a combination of upfront and contract research
fees, milestones, manufacturing product sales and product royalties.
We also have a significant collaboration with Bayer Healthcare LLC to develop BAY41-6551
(NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside
antibiotic. We originally developed the liquid aerosol inhalation platform and product and entered
into a collaboration with Bayer Healthcare LLC in 2007 for its development. We have another
proprietary product candidate, NKTR-063 (Inhaled Vancomycin), which uses the same aerosol platform
as BAY41-6551. A Phase 1 clinical trial has been completed for NKTR-063 to treat patients with
Gram-positive pneumonias.
On December 31, 2008, we completed the sale and transfer of certain pulmonary technology
rights, certain pulmonary collaboration agreements and approximately 140 of our dedicated pulmonary
personnel and operations to Novartis Pharma AG. We retained all of our rights to BAY41-6551 and
NKTR-063, certain rights to receive royalties on net sales of the Cipro Inhale (also known as
Ciprofloxacin Inhaled Powder or CIP) program with Bayer Schering Pharma AG that we transferred to
Novartis as part of the transaction, and we also retained certain intellectual property rights to
patents specific to inhaled insulin. In connection with the closing of the transaction, we also
terminated the Tobramycin Inhalation Powder (TIP) collaboration agreement with Novartis.
We were incorporated in California in 1990 and reincorporated in Delaware in 1998. We maintain
our executive offices at 201 Industrial Road, San Carlos, California 94070, and our main telephone
number is (650) 631-3100.
Our Technology Platform
With our expertise as a leader in the field of PEGylation, we have advanced our technology
platform to include first-generation PEGylation and new advanced polymer conjugate chemistries that
can be tailored in very specific and customized ways to optimize and significantly improve the
profile of a wide range of molecules and many classes of drugs and disease areas.
4
PEGylation has been a highly effective technology platform for the development of therapeutics
with significant commercial success, such as Roches PEGASYS® (PEG-interferon alfa-2a) and Amgens
Neulasta® (pegfilgrastim). All of the PEGylated drugs approved over the last fourteen years were
enabled with our PEGylation technology through our collaborations and licensing partnerships with
pharmaceutical companies. PEG (polyethylene glycol) is a versatile technology and is a water
soluble, amphiphilic, non-toxic, non-immunogenic compound that is safely cleared from the body.
Its primary use to date has been in currently approved biologic drugs to favorably alter their
pharmacokinetic or pharmacodynamic properties. However, in spite of its widespread success in
commercial drugs, there are limitations with the first-generation PEGylation approaches used with
biologics. These limitations include the inability of the earlier approaches of PEGylation
technology to be used successfully with small molecule drugs, antibody fragments and peptides, all
of which could potentially benefit from the application of the technology. Other limitations of
the early approaches of PEGylation technology include resulting sub-optimal bioavailability and
bioactivity, and its limited ability to be used to fine-tune properties of the drug, as well as its
inability to be used to create oral drugs.
With our expertise and proprietary technology in PEGylation, we have created the
next-generation of PEGylation technology. Our advanced polymer conjugate technology platform is
designed to overcome the limitations of the first generation of the technology platform and allow
the platform to be utilized with a broader range of molecules across many therapeutic areas.
Both our PEGylation and advanced polymer conjugate technology platforms have the potential to
offer one or more of the following benefits:
|
|
|
improve efficacy or safety in certain instances as a result of better pharmacokinetics,
pharmacodynamics, longer half-life and sustained exposure of the drug; |
|
|
|
improve targeting or binding affinity of a drug to its target receptors with the
potential to improve efficacy and reduce toxicity or drug resistance; |
|
|
|
enable oral administration of parenterally-administered drugs, or drugs that must be
administered intravenously or subcutaneously, and increase oral bioavailability of small
molecules; |
|
|
|
prevent drugs from crossing the blood-brain barrier and limiting undesirable central
nervous system effects; |
|
|
|
reduce first-pass metabolism effects of certain drug classes with the potential to
improve efficacy, which could reduce the need for other medicines and reduce toxicity; |
|
|
|
reduce rate of drug absorption and of elimination or metabolism by improving stability
of the drug in the body and providing it with more sufficient time to act on its target;
and |
|
|
|
reduce immune response to certain macromolecules with the potential to prolong their
effectiveness with repeated doses. |
We have a broad range of approaches that we may use when designing our own drug candidates,
some of which are outlined below:
Small Molecule Polymer Conjugates
Our customized approaches with small molecule polymer conjugates allows for the fine-tuning of
the physicochemical and pharmacological properties of small molecule oral drugs to potentially
increase their therapeutic benefit. In addition, this approach can enable oral administration of
subcutaneously-delivered small molecule drugs that have shown low bioavailability when delivered
orally. Benefits of this approach can also include: improved potency, increased oral
bioavailability, modified biodistribution with enhanced pharmacodynamics, and reduced transport
across specific membrane barriers in the body, such as the blood-brain barrier. A primary example
of the application of membrane transport inhibition, specifically
reducing transport across the blood-brain barrier is Oral NKTR-118, a novel peripheral opioid
antagonist that is in the final stages of Phase 2 clinical
development. An example of a drug candidate that uses this approach to avoid first-pass
metabolism is NKTR-140, a novel protease inhibitor in preclinical development.
5
Small Molecule Pro-Drug Conjugates
The pro-drug polymer conjugation approach can be used to optimize the pharmacokinetics and
pharmacodynamics of a small molecule drug to substantially increase both its efficacy and side
effect profile. We are currently using this platform with oncolytics, which typically have
sub-optimal half-lives that can limit their therapeutic efficacy. With our technology platform, we
believe that these drugs can be modulated for programmed release within the body, optimized
bioactivity and increased sustained exposure of active drug to tumor cells in the body. We are
using this approach with the two oncolytic candidates in our pipeline, NKTR-102, a novel PEGylated
form of irinotecan in Phase 2 clinical development, and NKTR-105, a novel PEGylated form of
docetaxel in Phase 1 clinical development.
Peptide Large Molecule Polymer Conjugates
Our customized approaches with large molecule polymer conjugates have enabled numerous
successful PEGylated biologics on the market today. We are using our advanced polymer conjugation
technology-based approach to enable peptides, which are much smaller in size than other biologics,
such as proteins and antibody fragments. We are in the early stages of research with a number of
peptides that utilize this proprietary approach. Peptides are important in modulating many
physiological processes in the body. Some of the benefits of working with peptides are: they are
small, more easily optimized, and can be rapidly investigated for therapeutic potential. However,
peptide drug discovery has been slowed by the extremely short half-life and limited bioavailability
of these molecules.
Based on our knowledge of the technology and biologics, our scientists have designed a novel
hydrolyzable linker that can be used to optimize the bioactivity of a peptide. Through rational
drug design and the use of our approach, a peptides pharmacokinetics and pharmacodynamics can be
substantially improved and its half-life can be significantly extended. The approach can also be
used with proteins and larger molecules, as well.
Antibody Fragment Conjugates
This approach uses a large molecular weight polyethylene glycol (PEG) conjugated to antibody
fragments in order to potentially improve their toxicity profile, extend their half-life and allow
for ease of synthesis with the antibody. The specially designed PEG then becomes part of the
antibody fragment Fc. Since the antibody fragment is more like a biologic, this conjugation has a
branched architecture with either stable or degradable linkage. This approach can be used to reduce
antigenicity, reduce glomerular filtration rate, and retain antigen-binding affinity and
recognition. There is currently one approved product on the market that utilizes our technology
with an antibody fragment, CIMZIA (certoluzimab pegol), which was developed by our partner UCB
Pharma and is approved for the treatment of Crohns Disease in the U.S.
Our Strategy
The key elements of our business strategy are outlined below:
Advance Our Internal Clinical Pipeline of Drug Candidates that Leverage Our PEGylation and
Advanced Polymer Conjugate Chemistry Platform
Our objective is to create value by advancing our lead drug candidates through early to
mid-stage clinical development. To support this strategy, in 2008, we significantly expanded our
strong internal expertise in our clinical development and regulatory
departments. We intend to decide on a product-by-product basis whether we wish to continue development into Phase 3 pivotal clinical
trials and commercialize products on our own, or seek a partner, or pursue a combination of these
approaches.
A key component of our development strategy is to potentially reduce the risks and time
associated with drug development by capitalizing on the known safety and efficacy of approved drugs
as well as established pharmacologic targets and drugs directed to those targets. For many of our
novel drug candidates, we may seek approval in indications for which the parent drugs have not been
studied or approved. We believe that the improved characteristics of our drug candidates will
provide meaningful benefit to patients compared to the existing therapies, and allow for approval
to provide new treatments for patients for which the parent drugs are not currently approved.
6
Ensure Future Growth of our Pipeline through Internal Research Efforts and Advancement of our
Preclinical Drug Candidates into Clinical Trials
We believe it is important to maintain a diverse pipeline of new drug candidates to continue
to build on the value of our business. Our early research organization is identifying new drug
candidates by applying our technology platform to a wide range of molecule classes, including small
molecules and large proteins, peptides and antibodies, across multiple therapeutic areas. We
continue to advance our most promising early research drug candidates into preclinical development
with the objective to advance these early stage research programs to human clinical studies over
the next several years.
Enter into Strategic and High-Value Partnerships to Bring Our Drugs to Market
Our partnering strategy is to enter into collaborations with larger pharmaceutical and
biotechnology companies at appropriate stages in our drug development process to fund further
clinical development, manage the global regulatory filing process, and market and sell the approved
drugs. The options for future collaboration arrangements range from comprehensive licensing
arrangements to co-promotion and co-development agreements with the structure of the collaboration
depending on factors such as the cost and complexity of development, marketing and
commercialization needs and therapeutic area focus.
Continue to Build a Leading Intellectual Property Estate in the Field of PEGylation and
Polymer Conjugate Chemistry across Therapeutic Modalities
We are committed to continuing to build on our intellectual property position in the field of
PEGylation and polymer conjugate chemistry. To that end, we have a comprehensive patent strategy
providing us with ownership of patents and patent applications covering a wide range of
approaches, including, among others, polymer materials, conjugates, formulations, synthesis,
therapeutic areas and methods of treatment.
Approved Drugs and Drug Candidates Enabled By Our Technology through Licensing Collaborations
The following table outlines our collaborations with a number of pharmaceutical companies that
license our technology, including Amgen, Schering-Plough, Baxter, UCB and F. Hoffmann-La Roche. A
total of nine products using our PEGylation technology have received regulatory approval in the
U.S. or Europe. There are also a number of other candidates that have been filed for approval or
are in various stages of clinical development. These collaborations generally contain several
elements including license rights to our proprietary technology, manufacturing and supply
agreements under which we may receive manufacturing revenue, milestone payments, and/or product
royalties on commercial sales.
|
|
|
|
|
|
|
Drug |
|
Primary or Target Indications |
|
Licensing Partner and Drug Marketer |
|
Status(1) |
Neulasta® (pegfilgrastim)
|
|
Neutropenia
|
|
Amgen Inc.
|
|
Approved |
PEGASYS® (peginterferon alfa-2a)
|
|
Hepatitis-C
|
|
F. Hoffmann-La Roche Ltd
|
|
Approved |
Somavert® (pegvisomant)
|
|
Acromegaly
|
|
Pfizer Inc.
|
|
Approved |
PEG-INTRON® (peginterferon alfa-2b)
|
|
Hepatitis-C
|
|
Schering-Plough Corporation
|
|
Approved |
Macugen® (pegaptanib sodium injection)
|
|
Age-related macular degeneration
|
|
OSI Pharmaceuticals (formerly Eyetech)
|
|
Approved |
CIMZIA (certolizumab pegol)
|
|
Crohns disease
|
|
UCB Pharma
|
|
Approved in U.S. and Switzerland |
MIRCERA® (C.E.R.A.) (Continuous
Erythropoietin Receptor Activator)
|
|
Anemia associated with chronic
kidney disease in patients on
dialysis and patients not on
dialysis
|
|
F. Hoffmann-La Roche Ltd
|
|
Approved in U.S. and EU
(Launched only in the EU)* |
CIMZIA (certolizumab pegol)
|
|
Rheumatoid arthritis
|
|
UCB Pharma
|
|
Filed in the U.S. and EU |
Hematide(synthetic peptide-based,
erythropoiesis- stimulating agent)
|
|
Anemia
|
|
Affymax, Inc.
|
|
Phase 3 |
MAP0004
|
|
Migraine
|
|
MAP Pharmaceuticals
|
|
Phase 3 |
Cipro Inhale
|
|
Cystic fibrosis lung infections
|
|
Bayer Schering Pharma AG
|
|
Phase 2** |
CIMZIA (certoluzimab pegol)
|
|
Psoriasis
|
|
UCB Pharma
|
|
Phase 2 |
CDP-791 (PEG-antibody fragment angiogenesis
inhibitor)
|
|
Non-small cell lung cancer
|
|
UCB Pharma
|
|
Phase 2 |
Longer-acting Factor VIII and other blood
clotting proteins
|
|
Hemophilia
|
|
Baxter
|
|
Preclinical |
|
|
|
(1) |
|
Status definitions are: |
Approvedregulatory approval to market and sell product obtained in the U.S., EU and other
countries.
Filed Products for which a New Drug Application (NDA) or Biologics License Application (BLA) has
been filed
Phase 3 or Pivotalproduct in large-scale clinical trials conducted to obtain regulatory approval
to market and sell the drug (these trials are typically initiated following encouraging Phase 2
trial results).
Phase 2product in clinical trials to establish dosing and efficacy in patients.
Phase 1 product in clinical trials, typically in healthy subjects, to test safety. In the case of
oncology drug candidates, Phase 1 clinical trials are typically conducted in cancer patients.
Research/preclinical
product is being studied in research by way of vitro studies and/or animal studies
|
|
|
* |
|
Amgen Inc. prevailed in a patent lawsuit against F. Hoffmann-La Roche Ltd and as a result of this
legal ruling Roche is currently prevented from marketing MIRCERA® in the U.S. |
|
** |
|
This product candidate was developed using our proprietary pulmonary delivery technology that was
transferred to Novartis in an asset sale transaction that closed on December 31, 2008. As part of
the transaction, Novartis assumed our rights and obligations for our Cipro Inhale agreements with
Bayer Schering PharmaAG; however, we maintained the rights to receive certain royalties on
commercial sales of Cipro Inhale if the product candidate is approved. |
7
Nektar Proprietary Internal Drug Candidates in Clinical Development
The following table summarizes our proprietary product development pipeline and significant
partnerships. The table includes the type of molecule or drug, the primary indication for the
product or product candidate, and the clinical trial status of the program.
|
|
|
|
|
Drug Candidate |
|
Target Indications |
|
Status (1) |
BAY41-6551 (NKTR-061, Amikacin Inhale)
|
|
Gram-negative pneumonias
|
|
Phase 2 (Partnered with Bayer Healthcare LLC)* |
NKTR-102 (PEGylated irinotecan)
|
|
Second-line colorectal cancer in
patients with the KRAS gene
mutation
|
|
Phase 2 |
NKTR-102 (PEGylated irinotecan)
|
|
Metastatic breast cancer
|
|
Phase 2 |
NKTR-102 (PEGylated irinotecan)
|
|
Metastatic ovarian cancer
|
|
Phase 2 |
NKTR-102 (PEGylated irinotecan)
|
|
Metastatic cervical cancer
|
|
Phase 2 |
Oral NKTR-118 (PEGylated naloxol)
|
|
Opioid-induced constipation (OIC)
|
|
Phase 2 |
NKTR-105 (PEGylated docetaxel)
|
|
Solid tumors
|
|
Phase 1 |
NKTR-063 (Inhaled Vancomycin)
|
|
Gram-positive pneumonias
|
|
Phase 1* |
NKTR-140 (protease inhibitor candidate)
|
|
HIV
|
|
Research/Preclinical |
NKTR-171 (undisclosed pain candidate)
|
|
Neuropathic pain
|
|
Research/Preclinical |
NKTR-125 (PEGylated antihistamine candidate)
|
|
Allergic rhinitis
|
|
Research/Preclinical |
|
|
|
(1) |
|
Status definitions are: |
Phase 3 or Pivotalproduct in large-scale clinical trials conducted to obtain regulatory approval
to market and sell the drug (these trials are typically initiated following encouraging Phase 2
trial results).
Phase 2product in clinical trials to establish dosing and efficacy in patients.
Phase 1 product in clinical trials, typically in healthy subjects, to test safety. In the case of
oncology drug candidates, Phase 1 clinical trials are typically conducted in cancer patients.
Research/preclinical
product is being studied in research by way of vitro studies and/or animal studies
|
|
|
* |
|
This product candidate uses a liquid aerosol technology platform that was transferred to Novartis
in the pulmonary asset sale transaction that was completed on December 31, 2008. As part of that
transaction, we retained an exclusive license to this technology for the development and
commercialization of this drug candidate originally developed by Nektar.
|
Overview of Selected Proprietary Product Development Programs
NKTR-102 (PEGylated irinotecan)
We are developing NKTR-102, a novel PEGylated form of irinotecan that was designed using our
advanced polymer conjugate technology platform. The product candidate is currently in Phase 2
clinical development. Irinotecan, also known as Camptosar®, is a topoisomerase I
inhibitor used for the treatment of solid tumors, including colorectal and lung cancers. By
applying our proprietary pro-drug conjugate technology to irinotecan, NKTR-102 has the potential to
be a more effective and tolerable anti-tumor agent. Using a proprietary approach that directly
conjugates the drug to a multi-arm polymer architecture, we are the first company to have created a
PEGylated small molecule with a unique pharmacokinetic profile that has demonstrated therapeutic
activity in patients.
NKTR-102 is currently in Phase 2 clinical development for the treatment of multiple cancers,
including colorectal, ovarian, and breast. In addition, we also plan to commence a Phase 2 trial
for NKTR-102 in patients with cervical cancer. A Phase 2 randomized trial of NKTR-102 was
initiated in early 2009 that will evaluate the efficacy and safety of NKTR-102 monotherapy versus
irinotecan in second-line colorectal cancer patients with the KRAS mutant gene. According to the
National Comprehensive Clinical Network, colorectal cancer is the most frequently diagnosed cancer
in men and women in the United States. In 2008, it is estimated that over 108,000 new cases of
colon cancer and approximately 40,780 cases of rectal cancer occurred. During the same year, it is
estimated that 49,960 people died from colon and rectal cancer. The primary endpoint of the Phase
2 placebo-controlled trial of NKTR-102 in colorectal cancer will be a clinically meaningful
improvement in progression-free survival as compared to standard irinotecan monotherapy. According
to recent data presented at the American Society of Clinical Oncology in 2008, it is estimated that
up to 45% of colorectal cancer cases have this mutation in the KRAS gene and do not respond to
EGFR-inhibitors, such as cetuximab. A Phase 2a study of NKTR-102 is also ongoing to evaluate
NKTR-102 in combination with cetuximab in 18 patients with refractory solid tumors, primarily
gastrointestinal-related cancers.
8
Two separate NKTR-102 Phase 2 studies are also ongoing in ovarian and breast cancers. These
studies are open label, single arm studies encompassing two treatment regimens (every 14 days or
every 21 days). Patients include those with
metastatic breast cancer with prior taxane treatment, those with metastatic and
platinum-resistant ovarian cancer. The Phase 2 study for cervical cancer that we plan to initiate
in 2009 is for patients with metastatic cervical cancer. The trials will evaluate the overall
response rate (ORR) of NKTR-102 monotherapy in each tumor setting, with secondary endpoints
including progression-free survival, safety and six and 12-month overall survival.
Ovarian, breast, and cervical cancers remain significant health problems for women worldwide.
In 2008, there were an estimated 21,650 new diagnoses and an estimated 15,520 deaths from ovarian
cancer in the United States and, historically, less than 40% of women with ovarian cancer are
cured. The American Cancer Society estimated that over 184,000 new cases of invasive breast
cancer were diagnosed and nearly 41,000 women died of breast cancer in the United States in 2008.
Cervical cancer is a major world health problem for women. The global annual incidence of cervical
cancer in 2002 was over 490,000 with an annual death rate of over 270,000. It is currently the
third most common cancer in women worldwide.
Oral NKTR-118 (PEGylated naloxol)
Oral
NKTR-118 is a novel oral drug candidate that is in the final stages
of Phase 2 clinical development, combines our
stable conjugate polymer technology with naloxol, a derivative of the opioid-antagonist drug
naloxone. On March 2, 2009, we announced that we were terminating the Phase 2 trial for Oral
NKTR-118 as a result of positive preliminary results. The peripheral opioid antagonist Oral
NKTR-118 targets opioid receptors within the enteric nervous system, which mediate opioid-induced
bowel dysfunction (OBD), a symptom resulting from opioid use that encompasses constipation,
bloating, abdominal cramping and gastroesophageal reflux. Opioid-induced constipation (OIC) is the
hallmark of this syndrome and is generally its most prominent component. According to the American
Pain Society, over 200 million opioid prescriptions are filled in the U.S. annually with worldwide
sales of opioids reaching $7.5 billion in 2007. Depending on the population studied and the
definitions used, constipation occurs in up to 90% of patients taking opioids. Currently, there
are no specific oral drugs approved or specifically indicated to treat OBD or OIC.
We are also conducting early discovery research on a new drug candidate, NKTR-119, which we
intend to develop as a co-formulation of NKTR-118 and a long-acting opioid analgesic. Our research
plan for NKTR-119 program is to create a long-acting opioid without the related gastrointestinal
side effects, such as OBD including OIC.
NKTR-105 (PEGylated docetaxel)
NKTR-105 is a novel PEGylated conjugate form of docetaxel, an anti-neoplastic agent belonging
to the taxoid family that acts by disrupting the microtubular network in cells. Docetaxel is a
major chemotherapy agent approved for use in five different cancer indications: breast, non-small
cell lung, prostate, gastric, and head and neck. Annual sales of docetaxel in 2007 exceeded $2 billion. Oncolytics, such as docetaxel, typically have sub-optimal half-lives which
can limit their therapeutic efficacy. Our advanced polymer conjugation technology can be used to
optimize the bioactivity of these drugs and increase the sustained exposure of active drug to tumor
cells in the body.
NKTR-105 is currently being evaluated in a Phase 1 clinical trial in cancer patients that
began in February 2009. The study will assess the safety, pharmacokinetics, and anti-tumor
activity of NKTR-105 in approximately 30 patients with refractory solid tumors who have failed all
prior available therapies.
NKTR-140 (protease inhibitor)
NKTR-140 is a novel protease inhibitor product candidate to treat human immunodeficiency virus
(HIV), which can lead to acquired immunodeficiency syndrome or AIDS. The product was developed
using Nektars advanced small molecule polymer conjugate technology. The drug candidate is
designed to have improved potency as compared to leading protease inhibitors used in clinical
practice today, and also to eliminate the need for a co-administered protease inhibitor booster,
such as ritonavir. NKTR-140 is currently being studied in a number of preclinical trials.
Overview of Select Licensing Partnerships for Approved Products
All of the approved products today that use our technology platforms are a result of licensing
collaborations with partners. We also have a number of product candidates in clinical development
by our partners that use our technology or involve rights over which we have patents or other
proprietary intellectual property. In a typical collaboration involving our PEGylation
technology, we license our proprietary intellectual property related to our PEGylation technology
or proprietary conjugated drug molecules in consideration for upfront payments, development
milestone payments and royalties from sales of the resulting commercial product as well as sales
milestones. We also manufacture and supply our proprietary PEGylation materials to our partners.
9
Neulasta®, Agreement with Amgen, Inc.
In July 1995, we entered into a non-exclusive supply and license agreement with Amgen, Inc.
(Amgen), pursuant to which we license our proprietary PEGylation technology to be used in the
development and manufacture of Neulasta. Neulasta selectively stimulates the production of
neutrophils that are depleted by cytotoxic chemotherapy, a condition called neutropenia that makes
it more difficult for the body to fight infections. We manufacture and supply our proprietary
PEGylation materials for Amgen on a fixed price basis. The term of the agreement is for a fixed
duration with a limited number of renewal options. This agreement is scheduled to expire in 2010.
PEGASYS®, Agreement with F. Hoffmann-La Roche Ltd
In February 1997, we entered into a license, manufacturing and supply agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), under which we granted Roche a worldwide,
exclusive license to use certain PEGylation materials to manufacture and commercialize a certain
class of products, of which PEGASYS is the only product currently commercialized. PEGASYS is
approved in the U.S., E.U. and other countries for the treatment of Hepatitis C and is designed to
help the patients immune system fight the Hepatitis C virus. We currently manufacture our
proprietary PEGylation materials for Roche on a price per gram basis. Roche has an option for a
license extension related to the agreement. The agreement expires on the later of January 10, 2015
or the expiration of our last relevant patent containing a valid claim.
Somavert®, Agreement with Pfizer, Inc.
In January 2000, we entered into a license, manufacturing and supply agreement with Sensus
Drug Development Corporation (subsequently acquired by Pharmacia Corp. in 2001 and then acquired by
Pfizer, Inc. in 2003), for the PEGylation of Somavert (pegvisomant), a human growth
hormone receptor antagonist for the treatment of acromegaly. We currently manufacture our
proprietary PEGylation reagent for Pfizer on a price per gram basis. The agreement expires on the
later of ten years from the grant of first marketing authorization in the designated territory,
which occurred in March 2003, or the expiration of our last relevant patent containing a valid
claim. In addition, Pfizer may terminate the agreement if marketing authorization is withdrawn or
marketing is no longer feasible due to certain circumstances, and either party may terminate for
cause if certain conditions are met.
PEG-Intron®, Agreement with Schering-Plough Corporation
In February 2000, we entered into a manufacturing and supply agreement with Schering-Plough
Corporation (Schering) for the manufacture and supply of our proprietary PEGylation materials to be
used by Schering in production of a pegylated recombinant human interferon-alpha (PEG-Intron).
PEG-Intron is a treatment for patients with Hepatitis C. We currently manufacture our proprietary
PEGylation materials for Schering on a price per gram basis. The agreement is for a fixed duration
with renewal terms conditioned upon mutual agreement.
Macugen®, Agreement with OSI Pharmaceuticals (formerly Eyetech)
In 2002, we entered into a license, manufacturing and supply agreement with Eyetech
Pharmaceuticals, Inc., subsequently acquired by OSI Pharmaceuticals, Inc. (OSI) in 2005, pursuant
to which we license our proprietary PEGylation technology for the development and commercialization
of Macugen®, a PEGylated anti-vascular endothelial growth factor aptamer currently approved in the
U.S. and E.U. for use in treating age-related macular degeneration. We currently manufacture our
proprietary PEGylation materials for OSI on a price per gram basis. Under the terms of the
agreement, we will receive royalties on net product sales in any particular country covered by a
valid patent claim for the longer of ten years from the date of the first commercial sale of the
product in that country or the manufacture, use or sale of such product in that country. The
agreement expires upon the expiration of our last relevant patent containing a valid claim. In
addition, OSI may terminate the agreement if marketing authorization is withdrawn or marketing is
no longer feasible due to certain circumstances, and either party may terminate for cause if
certain conditions are met.
CIMZIA, Agreement with UCB Pharma
In December 2000, we entered into a license, manufacturing and supply agreement for CIMZIA
(certolizumab pegol, CDP870) with Celltech Chiroscience Ltd., which was acquired by UCB Pharma
(UCB) in 2004. Under the terms of the agreement, UCB is responsible for all clinical development,
regulatory, and commercialization expenses. We have the right to receive manufacturing revenue on
a cost-plus basis and royalties on net product sales. We are entitled to receive
royalties on net sales of the CIMZIA product in any particular country for the longer of ten
years from the first commercial sale of the product in that country or the expiration of patent
rights in that particular country. CIMZIA is currently approved in the treatment of Crohns
Disease in the U.S. The agreement expires upon the expiration of all of UCBs royalty obligations,
provided that the agreement can be extended for successive two year renewal periods upon mutual
agreement of the parties. In addition, UCB may terminate the agreement should it cease the
development and marketing of CIMZIA and either party may terminate for cause under certain
conditions.
10
In April 2008, UCB received FDA approval for CIMZIA in the U.S. in the treatment of moderate
to severe Crohns disease. Crohns disease is a chronic digestive disorder of the intestines
commonly referred to as inflammatory bowel disease that affects an estimated 400,000 to 600,000
individuals in the U.S. In March 2008, the European Medicines Agency (EMEA) rejected the appeal
following CHMP refusal of the MAA for CIMZIA in the treatment of patients with Crohns disease, a
chronic and debilitating inflammatory disease.
In December 2007, UCB submitted a Biologics License Application (BLA) to the FDA for CIMZIA
for the treatment of rheumatoid arthritis. Rheumatoid arthritis is an autoimmune disease that
causes chronic inflammation of the joints. The submission was accepted in February of 2008. In
January 2009, UCB announced that the FDA issued a Complete Response Letter (CRL) relating to the
BLA of CIMZIA, the first PEGylated anti-TNF, for the treatment of rheumatoid arthritis. In July
2008, UCB announced that a Marketing Authorisation Application (MAA) has been submitted to and
accepted for review by the EMEA requesting the approval of CIMZIA (certolizumab pegol) as a
subcutaneous treatment for adults with moderate to severe active rheumatoid arthritis.
UCB is also conducting clinical trials on CIMZIA for psoriasis and other indications. The
product is in Phase 2 trials for the treatment of psoriasis.
MIRCERA® (C.E.R.A.) (Continuous Erythropoietin Receptor Activator), Agreement with F. Hoffmann-La
Roche Ltd
In December 2000, we entered into a license, manufacturing and supply agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), which was amended and restated in its
entirety in December 2005. Pursuant to the agreement, we license our proprietary PEGylation
materials for use in the development and manufacture of Roches MIRCERA product. MIRCERA is a
novel continuous erythropoietin receptor activator indicated for the treatment of anemia associated
with chronic kidney disease in patients on dialysis and patients not on dialysis. We are entitled
to receive royalties on net sales of the MIRCERA product in any particular country for the longer
of ten years from the first commercial sale of the product in that country or the expiration of
patent rights in that particular country. The agreement expires upon the expiration of all of
Roches royalty obligations, unless earlier terminated by Roche for convenience or by either party
for cause under certain conditions.
In April 2006, Roche filed a BLA for MIRCERA with the FDA for the treatment of anemia
associated with chronic kidney disease, including patients on dialysis or not on dialysis, and an
MAA with the EMEA to treat patients with chronic kidney disease. In May 2007, MIRCERA was approved
in the EU and the product was subsequently launched by Roche in the EU in August of 2007. In
November 2007, the FDA approved Roches BLA application for MIRCERA but the product has not been
launched in the U.S. as a result of patent-related issues.
In October 2008, a federal district court ruled in favor of Amgen Inc. in a patent
infringement lawsuit involving MIRCERA and issued a permanent injunction which prevents Roche from
marketing or selling MIRCERA in the U.S. even though the FDA approved MIRCERA. This federal
district court decision is currently on appeal to the U.S. Court of Appeals for the Federal
Circuit. Given the uncertain and lengthy nature of the legal appeal process, it is not possible
for us to estimate the timing of a decision on Roches appeal or potential remand of this case for
additional proceedings. If Roche is not successful in getting relief from the current permanent
injunction, we estimate that Roche would not be able to market or sell MIRCERA in the U.S. until
2013 at the earliest.
11
Overview of Select Partnered Drug Development Programs
BAY41-6551 (NKTR-061, Amikacin Inhale), Agreement with Bayer Healthcare LLC
In August 2007, we entered into a co-development, license and co-promotion agreement with
Bayer Healthcare LLC (Bayer) to develop a specially-formulated Amikacin (BAY41-6551, NKTR-061,
Amikacin Inhale). Under the terms of the agreement, Bayer is responsible for most future clinical
development and commercialization costs, all activities to support worldwide regulatory filings,
approvals and related activities, further development of formulated Amikacin and final product
packaging for BAY41-6551. We are responsible for any future development of the nebulizer device
used in BAY41-6551through the completion of Phase 3 clinical trials and scale-up for commercialization.
Under the terms of the agreement, we are entitled to development milestones and sales milestones
upon achievement of certain annual sales targets. We are also entitled to royalties based on
annual worldwide net sales of BAY41-6551. Our right to receive these royalties in any particular
country will expire upon the later of ten years after the first commercial sale of the product in
that country or the expiration of certain patent rights in that particular country, subject to
certain exceptions. The agreement expires in relation to a particular country upon the expiration
of all royalty and payment obligations between the parties related to such country. Subject to
termination fee payment obligations, Bayer also has the right to terminate the agreement for
convenience. In addition, the agreement may also be terminated by either party for certain product
safety concerns, the products failure to meet certain minimum commercial profile requirements or
uncured material breaches by the other party. For certain Bayer terminations, we may have
reimbursement obligations to Bayer.
BAY41-6551 is under development to treat Gram-negative pneumonias, including Hospital-Acquired
(HAP), Healthcare-Associated, and Ventilator-Associated pneumonias. Gram-negative pneumonias are
often the result of complications of other patient conditions or surgeries. BAY41-6551 will be
adjunctive therapy to the current antibiotic therapies administered intravenously as standard of
care. The targeted aerosol delivery platform in BAY41-6551 delivers antimicrobial agent directly to
the site of infection in the lungs. The product can be integrated with conventional mechanical
ventilators or used as a hand-held off-vent device for patients no longer requiring breathing
assistance.
Gram-negative pneumonia carries a mortality risk of over 50% in mechanically-ventilated
patients and accounts for a substantial proportion of the pneumonias in intensive care units (ICUs)
today.
Hematide, Agreement with Affymax, Inc.
In April 2004, we entered into a license, manufacturing and supply agreement with Affymax,
Inc. (Affymax), under which we granted Affymax a worldwide, non-exclusive license under certain of
our proprietary PEGylation technology to develop, manufacture and commercialize Hematide. We
currently manufacture our proprietary PEGylation materials for Affymax on a fixed price basis
subject to annual adjustments. Affymax has an option to convert this manufacturing pricing
arrangement to cost plus at any time prior to the date the NDA for Hematide is submitted to the
FDA. In addition, Affymax is responsible for all clinical development, regulatory and
commercialization expenses and we are entitled to development milestones and royalties on net sales
of Hematide. Our right to receive royalties in any particular country will expire upon the later
of ten years after the first commercial sale of the product in that country or the expiration of
patent rights in that particular country. The agreement expires on a country-by-country basis upon
the expiration of Affymaxs royalty obligations. The agreement may also be terminated by either
party for the other partys continued material breach after a cure period or by us in the event
that Affymax challenges the validity or enforceability of any patent licensed to them under the
agreement.
CDP-791, Agreement with UCB Pharma
In December 2000, we entered into a licensing, manufacturing and supply agreement with
Celltech Chiroscience Ltd. (subsequently acquired by UCB Pharma or UCB) for several PEGylated
antibody fragment products, one of which was a PEG-antibody fragment angiogenesis inhibitor for
non-small cell lung cancer. In August 2002, the agreement was superseded by an agreement that
relates only to CDP-791. Under the terms of the 2002 agreement, we provide development and
manufacturing services for the CDP-791 product. UCB is responsible for all clinical development,
regulatory and commercialization expenses. We have the right to receive development milestone
payments, manufacturing revenue on a cost-plus basis and royalties on net product sales following
commercial launch. Our right to receive royalties in any particular country will expire upon the
later of between ten or twelve years (which period depends on certain factors) after the first
commercial sale of the product in that country or the expiration of patent rights in that
particular country. The agreement expires upon the expiration of all of UCBs royalty obligations,
provided that the agreement can be extended for successive two year renewal periods upon mutual
agreement of the parties. In addition, UCB may terminate the agreement should it cease the
development and marketing of the product and either party may terminate for cause under certain
conditions.
12
Hemophilia Programs, Agreement with Subsidiaries of Baxter International
In September 2005, we entered into an exclusive research, development, license and
manufacturing and supply agreement with Baxter Healthcare SA and Baxter Healthcare Corporation
(Baxter) to develop products with an extended half-life for the treatment and prophylaxis of
Hemophilia A patients using our PEGylation technology. In December 2007, we expanded our agreement
with Baxter to include the license of our PEGylation technology and proprietary PEGylation methods
with the potential to improve the half-life of any future products Baxter may develop for the
treatment and prophylaxis of Hemophilia B patients. Under the terms of the agreement, we are
entitled to research and development
funding, and we manufacture our proprietary PEGylation materials for Baxter on a cost plus
basis. Baxter is responsible for all clinical development, regulatory, and commercialization
expenses. In relation to Hemophilia A, we are entitled to development milestones and royalties on
net sales varying by product and country of sale. Our right to receive these royalties in any
particular country will expire upon the later of ten years after the first commercial sale of the
product in that country or the expiration of patent rights in certain designated countries or in
that particular country. In relation to Hemophilia B, we are entitled to development and sales
milestones and royalties on net sales varying by product and country of sale. Our right to receive
these royalties in any particular country will expire upon the later of twelve years after the
first commercial sale of the product in that country or the expiration of patent rights in certain
designated countries or in that particular country. The agreement expires in relation to a
particular product and country upon the expiration of all of Baxters royalty obligations related
to such product and country. The agreement may also be terminated by either party for the other
partys material breach or insolvency, provided that such other party has been given a chance to
cure or remedy such breach or insolvency. Subject to certain limitations as to time, and possible
termination fee payment obligations, Baxter also has the right to terminate the agreement for
convenience. We have the right to terminate the agreement or convert Baxters license from
exclusive to non-exclusive in the event Baxter fails to comply with certain diligence obligations.
Cipro Inhale, Assigned to Novartis as of December 31, 2008
We were a party to a collaborative research, development and commercialization agreement with
Bayer Schering Pharma AG related to the development of an inhaled powder formulation of
Ciprofloxacin for the treatment of chronic lung infections caused by Pseudomonas aeruginosa in
cystic fibrosis patients. As of December 31, 2008, we assigned the collaborative research,
development and commercialization agreement to Novartis Pharma AG in connection with the closing of
the asset sale transaction. Pursuant to the terms of the transaction, we maintain the right to
receive certain potential royalties in the future based on net product sales if Cipro Inhale
receives regulatory approval and is successfully commercialized.
2008 Developments in Our Business
Exit from the Inhaled Insulin Programs
In 1995, we entered into a collaborative development and licensing agreement with Pfizer to
develop and market Exubera® and, in 2006 and 2007, we entered into a series of interim
letter agreements with Pfizer to develop a next generation form of dry powder inhaled insulin and
proprietary inhaler device, also known as NGI. In January 2006, Exubera received marketing approval
in the U.S. and EU for the treatment of adults with Type 1 and Type 2 diabetes. Under the
collaborative development and licensing agreement, Pfizer had sole responsibility for marketing and
selling Exubera. We performed all of the manufacturing of the Exubera dry powder insulin, and
through third party contract manufacturers (Bespak Europe Ltd. and Tech Group, Inc.), we supplied
Pfizer with the Exubera inhalers. Our total revenue from Pfizer was nil, $189.1 million, and
$139.9 million, representing 0%, 69% and 64% of total revenue, for the years ended December 31,
2008, 2007, and 2006, respectively.
On October 18, 2007, Pfizer announced that it was exiting the Exubera business and gave notice
of termination under our collaborative development and licensing agreement. On November 9, 2007,
we entered into a termination agreement and mutual release with Pfizer. Under this agreement we
received a one-time payment of $135.0 million in November 2007 from Pfizer in satisfaction of all
outstanding contractual obligations under our then-existing agreements relating to Exubera and NGI.
All agreements between Pfizer and us related to Exubera and NGI, other than the termination
agreement and mutual release and a related interim Exubera manufacturing maintenance letter,
terminated on November 9, 2007. In February 2008, we entered into a termination agreement with
Bespak and Tech Group pursuant to which we paid an aggregate of $39.9 million in satisfaction of
outstanding accounts payable and termination costs and expenses that were due under the Exubera
inhaler contract manufacturing agreement. We also entered into a maintenance agreement with both
Pfizer and Tech Group to preserve key personnel and manufacturing capacity to support potential
future Exubera inhaler manufacturing if we found a new partner for the inhaled insulin program.
On April 9, 2008, we announced that we had ceased all negotiations with potential partners for
Exubera and NGI as a result of new data analysis from ongoing clinical trials conducted by Pfizer
which indicated an increase in the number of new cases of lung cancer in Exubera patients who were
former smokers as compared to patients in the control group who were former smokers. In April
2008, we ceased all spending associated with maintaining Exubera manufacturing capacity and any
further NGI development, including, but not limited to, terminating the Exubera manufacturing
capacity maintenance arrangements with Pfizer and Tech Group.
13
Asset Sale to Novartis
On December 31, 2008, we completed the sale of certain assets related to our pulmonary
business, associated technology and intellectual property to Novartis Pharma AG and Novartis
Pharmaceuticals Corporation (together referred to as Novartis) for a purchase price of $115.0
million in cash (Novartis Pulmonary Asset Sale). Under the terms of the transaction, we
transferred to Novartis certain assets and obligations related to our pulmonary technology,
development and manufacturing operations including:
|
|
|
dry powder and liquid pulmonary technology platform including but not limited to our
pulmonary inhalation devices, formulation technology, manufacturing technology and related
intellectual property; |
|
|
|
capital equipment, information systems and facility lease obligations for our pulmonary
development and manufacturing facility in San Carlos, California; |
|
|
|
manufacturing and associated development services payments for the Cipro Inhale program; |
|
|
|
manufacturing and royalty rights to the Tobramycin Inhalation Powder (TIP) program
through the termination of our collaboration agreement with Novartis; |
|
|
|
certain other interests that we had in two private companies; and |
|
|
|
approximately 140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing operations. |
In consideration for the transfer of the above described pulmonary assets, we received $115.0
million in cash on December 31, 2008. In addition, we retained all of our rights to BAY41-6551,
partnered with Bayer Healthcare LLC, certain royalty rights for the Cipro Inhale development
program partnered with Bayer Schering Pharma AG, all rights to the ongoing development program for
NKTR-063, and certain intellectual property rights specific to inhaled insulin.
In connection with Novartis Pulmonary Asset Sale, we also entered into an Exclusive License
Agreement with Novartis Pharma. Pursuant to the Exclusive License Agreement, Novartis Pharma
granted back to us an exclusive, irrevocable, perpetual, non-transferable, royalty-free and
worldwide license under certain specific patent rights and other related intellectual property
rights acquired by Novartis Pharma from Nektar in the transaction, as well as certain improvements
or modifications thereto that are made by Novartis Pharma after the closing. Certain of such
patent rights and other related intellectual property rights relate to our development program for
NKTR-063 or are necessary for us to satisfy certain of our continuing contractual obligations to
third parties, including in connection with development, manufacture, sale, and commercialization
activities related to BAY41-6551. We also entered into a service agreement pursuant to which we
have subcontracted to Novartis certain services to be performed related to our partnered program
for BAY41-6551 and a transition services agreement pursuant to which Novartis and we will provide
each other with specified services for limited time periods following the closing of the Novartis
Pulmonary Asset Sale to facilitate the transition of the acquired assets and business from us to
Novartis.
Research and Development
Our total Research and development expenditures can be disaggregated into the following
significant types of expenses (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Salaries and employee benefits |
|
$ |
58.4 |
|
|
$ |
70.7 |
|
|
$ |
69.9 |
|
Stock compensation expense |
|
|
4.6 |
|
|
|
6.3 |
|
|
|
9.7 |
|
Facility and equipment |
|
|
25.9 |
|
|
|
33.9 |
|
|
|
31.0 |
|
Outside services, including Contract Research Organizations |
|
|
40.2 |
|
|
|
26.8 |
|
|
|
24.1 |
|
Supplies, including clinical trial materials |
|
|
19.0 |
|
|
|
10.8 |
|
|
|
8.9 |
|
Travel, lodging, and meals |
|
|
3.3 |
|
|
|
2.2 |
|
|
|
2.4 |
|
Other |
|
|
3.0 |
|
|
|
2.9 |
|
|
|
3.4 |
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
154.4 |
|
|
$ |
153.6 |
|
|
$ |
149.4 |
|
|
|
|
|
|
|
|
|
|
|
14
Manufacturing and Supply
We have a manufacturing facility located in Huntsville, Alabama related to our PEGylation and
advanced polymer conjugate technologies. This facility is capable of manufacturing PEGylation
derivatives and starting materials for active pharmaceutical ingredients (APIs). The facility is also used to produce
APIs for clinical development for our proprietary product candidates that utilize our PEGylation
and advanced polymer conjugate technology. The facility and associated equipment is designed and
operated to be in compliance with the guidelines of the International Conference on Harmonization
of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) applicable to
APIs (ICH Q7A guidelines).
We source drug starting materials for our manufacturing activities from one or more suppliers.
If we are responsible for manufacturing activities under a collaboration arrangement, we typically
source drug starting materials from the collaboration partner. For the drug starting materials
necessary for our proprietary drug candidate development, we have agreements for the supply of such
drug components with drug suppliers that we believe have sufficient capacity to meet our demands.
However, from time to time, we source critical raw materials from one or a limited number of
suppliers and there is a risk that if such supply were interrupted, it would materially harm our
business. In addition, we typically order raw materials on a purchase order basis and do not
enter into long-term dedicated capacity or minimum supply arrangements.
Prior to the closing of the Novartis Pulmonary Asset Sale on December 31, 2008, we operated a
drug powder manufacturing and packaging facility in San Carlos, California capable of producing
drug powders in quantities sufficient for clinical trials of product candidates utilizing our
pulmonary technology. As part of the Novartis Pulmonary Asset Sale, we transferred this
manufacturing facility and the related operations, and Novartis hired approximately 140 of the
related supporting personnel, as of December 31, 2008.
Government Regulation
The research and development, clinical testing, manufacture and marketing of products using
our technologies are subject to regulation by the Food and Drug Administration (FDA) and by
comparable regulatory agencies in other countries. These national agencies and other federal, state
and local entities regulate, among other things, research and development activities and the
testing (in vitro, in animals, and in human clinical trials), manufacture, labeling, storage,
recordkeeping, approval, marketing, advertising and promotion of our products.
The approval process required by the FDA before a product using any of our technologies may be
marketed in the U.S. depends on whether the chemical composition of the product has previously been
approved for use in other dosage forms. If the product is a new chemical entity that has not been
previously approved, the process includes the following:
|
|
|
extensive preclinical laboratory and animal testing; |
|
|
|
submission of an Investigational New Drug application (IND) prior to commencing
clinical trials; |
|
|
|
adequate and well-controlled human clinical trials to establish the safety and
efficacy of the drug for the intended indication; and |
|
|
|
submission to the FDA of a New Drug Application (NDA) for approval of a drug, a
Biologic License Application (BLA) for approval of a biological product or a Premarket
Approval Application (PMA) or Premarket Notification 510(k) for a medical device product
(a 510(k)). |
If the active chemical ingredient has been previously approved by the FDA, the approval
process is similar, except that certain preclinical tests relating to systemic toxicity normally
required for the IND and NDA or BLA may not be necessary if the company has a right of reference to
such data or is eligible for approval under Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act.
Preclinical tests include laboratory evaluation of product chemistry and animal studies to
assess the safety and efficacy of the product and its chosen formulation. Preclinical safety tests
must be conducted by laboratories that comply with FDA good laboratory practices (GLP) regulations.
The results of the preclinical tests for drugs, biological products and
combination products subject to the primary jurisdiction of the FDAs Center for Drug
Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) are submitted
to the FDA as part of the IND and are reviewed by the FDA before clinical trials can begin.
Clinical trials may begin 30 days after receipt of the IND by the FDA, unless the FDA raises
objections or requires clarification within that period.
15
Clinical trials involve the administration of the drug to healthy volunteers or patients under
the supervision of a qualified, identified medical investigator according to a protocol submitted
in the IND for FDA review. Drug products to be used in clinical trials must be manufactured
according to current good manufacturing practices (cGMP). Clinical trials are conducted in
accordance with protocols that detail the objectives of the study and the parameters to be used to
monitor participant safety and product efficacy as well as other criteria to be evaluated in the
study. Each protocol is submitted to the FDA in the IND.
Apart from the IND process described above, each clinical study must be reviewed by an
independent Institutional Review Board (IRB) and the IRB must be kept current with respect to the
status of the clinical study. The IRB considers, among other things, ethical factors, the potential
risks to subjects participating in the trial and the possible liability to the institution where
the trial is conducted. The IRB also reviews and approves the informed consent form to be signed by
the trial participants and any significant changes in the clinical study.
Clinical trials are typically conducted in three sequential phases. Phase 1 involves the
initial introduction of the drug into healthy human subjects (in most cases) and the product
generally is tested for tolerability, pharmacokinetics, absorption, metabolism and excretion. Phase
2 involves studies in a limited patient population to:
|
|
|
determine the preliminary efficacy of the product for specific targeted indications; |
|
|
|
determine dosage and regimen of administration; and |
|
|
|
identify possible adverse effects and safety risks. |
If Phase 2 trials demonstrate that a product appears to be effective and to have an acceptable
safety profile, Phase 3 trials are undertaken to evaluate the further clinical efficacy and safety
of the drug and formulation within an expanded patient population at geographically dispersed
clinical study sites and in large enough trials to provide statistical proof of efficacy and
tolerability. The FDA, the clinical trial sponsor, the investigators or the IRB may suspend
clinical trials at any time if any one of them believes that study participants are being subjected
to an unacceptable health risk. In some cases, the FDA and the drug sponsor may determine that
Phase 2 trials are not needed prior to entering Phase 3 trials.
Following a series of formal and informal meetings between the drug sponsor and the regulatory
agencies, the results of product development, preclinical studies and clinical studies are
submitted to the FDA as an NDA or BLA for approval of the marketing and commercial shipment of the
drug product. The FDA may deny approval if applicable regulatory criteria are not satisfied or may
require additional clinical or pharmaceutical testing or requirements. Even if such data are
submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy all of the criteria
for approval. Additionally, the approved labeling may narrowly limit the conditions of use of the
product, including the intended uses, or impose warnings, precautions or contraindications which
could significantly limit the potential market for the product. Further, as a condition of
approval, the FDA may impose post-market surveillance, or Phase 4, studies or risk management
programs. Product approvals, once obtained, may be withdrawn if compliance with regulatory
standards is not maintained or if safety concerns arise after the product reaches the market. The
FDA may require additional post-marketing clinical testing and pharmacovigilance programs to
monitor the effect of drug products that have been commercialized and has the power to prevent or
limit future marketing of the product based on the results of such programs. After approval, there
are ongoing reporting obligations concerning adverse reactions associated with the product,
including expedited reports for serious and unexpected adverse events.
Each manufacturer of drug product for the U.S. market must be registered with the FDA and
typically is inspected by the FDA prior to NDA or BLA approval of a drug product manufactured by
such establishment. Establishments handling controlled substances must also be licensed by the U.S.
Drug Enforcement Administration. Manufacturing establishments of U.S. marketed products are subject
to inspections by the FDA for compliance with cGMP and other U.S. regulatory requirements. They are
also subject to U.S. federal, state, and local regulations regarding workplace safety,
environmental protection and hazardous and controlled substance controls, among others.
A number of the drugs we are developing are already approved for marketing by the FDA in
another form or using another delivery system. We believe that, when working with drugs approved in
other forms, the approval process for products using our alternative drug delivery or formulation
technologies may involve less risk and require fewer tests than new chemical entities do. However,
we expect that our formulations will often use excipients not currently approved for use. Use of
these excipients will require additional toxicological testing that may increase the costs of, or
length of time needed to, gain regulatory approval. In addition, as they relate to our products,
regulatory procedures may change as regulators gain relevant experience, and any such changes may
delay or increase the cost of regulatory approvals.
16
For product candidates currently under development utilizing pulmonary technology, the
pulmonary inhaler devices are considered to be part of a drug and device combination for deep lung
delivery of each specific molecule. The FDA will make a determination as to the most appropriate
center and division within the agency that will assume prime responsibility for the review of the
applicable applications, which would consist of an IND and an NDA or BLA where CDER or CBER are
determined to have primary jurisdiction or an investigational device exemption application and PMA
or 510(k) where the Center for Devices and Radiological Health (CDRH) is determined to have primary
jurisdiction. In the case of our product candidates, CDER in consultation with CDRH could be
involved in the review. The assessment of jurisdiction within the FDA is based upon the primary
mode of action of the drug or the location of the specific expertise in one of the centers.
Where CDRH is determined to have primary jurisdiction over a product, 510(k) clearance or PMA
approval is required. Medical devices are classified into one of three classesClass I, Class II,
or Class IIIdepending on the degree of risk associated with each medical device and the extent of
control needed to ensure safety and effectiveness. Devices deemed to pose lower risks are placed in
either Class I or II, which requires the manufacturer to submit to the FDA a Premarket Notification
requesting permission to commercially distribute the device. This process is known as 510(k)
clearance. Some low risk devices are exempted from this requirement. Devices deemed by the FDA to
pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices
deemed not substantially equivalent to a previously cleared 510(k) device are placed in Class III,
requiring PMA approval.
To date, our partners have generally been responsible for clinical and regulatory approval
procedures, but we may participate in this process by submitting to the FDA a drug master file
developed and maintained by us which contains data concerning the manufacturing processes for the
inhaler device or drug. For our proprietary products, we prepare and submit an IND and are
responsible for additional clinical and regulatory procedures for product candidates being
developed under an IND. The clinical and manufacturing development and regulatory review and
approval process generally takes a number of years and requires the expenditure of substantial
resources. Our ability to manufacture and market products, whether developed by us or under
collaboration agreements, ultimately depends upon the completion of satisfactory clinical trials
and success in obtaining marketing approvals from the FDA and equivalent foreign health
authorities.
Sales of our products outside the U.S. are subject to local regulatory requirements governing
clinical trials and marketing approval for drugs. Such requirements vary widely from country to
country.
In the U.S., under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs
intended to treat a rare disease or condition, which is generally a disease or condition that
affects fewer than 200,000 individuals in the U.S. The company that obtains the first FDA approval
for a designated orphan drug for a rare disease receives marketing exclusivity for use of that drug
for the designated condition for a period of seven years. In addition, the Orphan Drug Act provides
for protocol assistance, tax credits, research grants, and exclusions from user fees for sponsors
of orphan products. Once a product receives orphan drug exclusivity, a second product that is
considered to be the same drug for the same indication may be approved during the exclusivity
period only if the second product is shown to be clinically superior to the original orphan drug
in that it is more effective, safer or otherwise makes a major contribution to patient care or
the holder of exclusive approval cannot assure the availability of sufficient quantities of the
orphan drug to meet the needs of patients with the disease or condition for which the drug was
designated.
In the U.S., the FDA may grant Fast Track designation to a product candidate, which allows the
FDA to expedite the review of new drugs that are intended for serious or life-threatening
conditions and that demonstrate the potential to address unmet medical needs. An important feature
of Fast Track designation is that it emphasizes the critical nature of close, early communication
between the FDA and the sponsor company to improve the efficiency of product development.
Patents and Proprietary Rights
We invest a significant portion of our resources in the creation and development of new drug
compounds that serve unmet needs in the treatment of patients. In doing so, we create intellectual
property. As part of our strategy to secure our intellectual property created by these efforts, we
routinely apply for patents, rely on trade secret protection, and enter into contractual
obligations with third parties. When appropriate, we will defend our intellectual property, taking
any and all legal remedies available to us, including, for example, asserting patent infringement,
trade secret misappropriation and breach of contract claims. As of January 1, 2009, we owned
approximately 80 U.S. and 335 foreign patents. Currently, we have over approximately 56 patent
applications pending in the U.S. and 466 pending in other countries.
A focus area of our current drug creation and development efforts centers on our innovations
in and improvements to our PEGylation and advanced polymer conjugate technology platforms. In this
area, our patent portfolio contains patents and patent applications that encompass our PEGylation
and advanced polymer conjugate technology platforms, some of which we acquired in our acquisition
of Shearwater Corporation in June 2001. More specifically, our patents and patent applications
cover polymer architecture, drug conjugates, formulations, methods of making polymers and polymer
conjugates, and methods of administering polymer conjugates. Our patent strategy is to file patent
applications on innovations and improvements to cover a significant majority of the major
pharmaceutical markets in the world. Generally, patents have a term of twenty years from the
earliest priority date (assuming all maintenance fees are paid). In some instances, patent terms
can be increased or decreased, depending on the laws and regulations of the country or jurisdiction
that issued that patent.
17
In connection with the Novartis Pulmonary Asset Sale, as of December 31, 2008, we entered into
an exclusive license agreement with Novartis Pharma. Pursuant to the exclusive license agreement,
Novartis Pharma grants back to us an exclusive, irrevocable, perpetual, royalty-free and worldwide
license under certain specific patent rights and other related intellectual property rights
acquired by Novartis from us in the Novartis Pulmonary Asset Sale, as well as certain improvements
or modifications thereto that are made by Novartis. Certain of such patent rights and other
related intellectual property rights relate to our development program for NKTR-063 or are
necessary for us to satisfy certain continuing contractual obligations to third parties, including
in connection with development, manufacture, sale, and commercialization activities related to
BAY41-6551 partnered with Bayer Healthcare LLC.
Our revenue is derived from our collaboration agreements with partners, under which we may
receive contract research payments, milestone payments based on clinical progress, regulatory
progress or net sales achievements, royalties or manufacturing revenue. Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche represented 24%, 16%,
15%, and 14%, respectively, of our total revenue during the year ended December 31, 2008. No other
partner accounted for more than 10% of our total revenue during the year ended December 31, 2008.
If we are unable to continue to develop and protect proprietary intellectual property and license
our technologies to partners, our business, results of operations and financial condition could
suffer.
The patent positions of pharmaceutical and biotechnology companies, including ours, involve
complex legal and factual issues. There can be no assurance that the patents we apply for will be
issued to us or that the patents that are issued to us will be held valid and enforceable in a
court of law. Even for patents that are enforceable, we anticipate that any attempt to enforce our
patents would be time consuming and costly. Additionally, the coverage claimed in a patent
application can be significantly reduced before the patent is issued. As a consequence, we do not
know whether any of our pending patent applications will be granted with broad coverage or whether
the claims that eventually issue, or those that have issued, will be circumvented. Since
publication of discoveries in scientific or patent literature often lag behind actual discoveries,
we cannot be certain that we were the first inventor of inventions covered by our patents or patent
applications or that we were the first to file patent applications for such inventions. Moreover,
we may have to participate in interference proceedings in the U.S. Patent and Trademark Office,
which could result in substantial cost to us, even if the eventual outcome is favorable. An adverse
outcome could subject us to significant liabilities to third parties, require disputed rights to be
licensed from or to third parties or require us to cease using the technology in dispute.
U.S. and foreign patent rights and other proprietary rights exist that are owned by third
parties and relate to pharmaceutical compositions and reagents, medical devices and equipment and
methods for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict
with any certainty which, if any, of these rights will be considered relevant to our technology by
authorities in the various jurisdictions where such rights exist, nor can we predict with certainty
which, if any, of these rights will or may be asserted against us by third parties. We could incur
substantial costs in defending ourselves and our partners against any such claims. Furthermore,
parties making such claims may be able to obtain injunctive or other equitable relief, which could
effectively block our ability to develop or commercialize some or
all of our products in the U.S. and abroad and could result in the award of substantial
damages. In the event of a claim of infringement, we or our partners may be required to obtain one
or more licenses from third parties. There can be no assurance that we can obtain a license to any
technology that we determine we need on reasonable terms, if at all, or that we could develop or
otherwise obtain alternative technology. The failure to obtain licenses if needed may have a
material adverse effect on our business, results of operations and financial condition.
We also rely on trade secret protection for our confidential and proprietary information. No
assurance can be given that we can meaningfully protect our trade secrets. Others may independently
develop substantially equivalent confidential and proprietary information or otherwise gain access
to, or disclose, our trade secrets.
In certain situations in which we work with drugs covered by one or more patents, our ability
to develop and commercialize our technologies may be affected by a limited or a complete lack of
unfettered access to these proprietary drugs. Even if we believe we are free to work with a
proprietary drug, we cannot guarantee we will not be accused of, or determined to be, infringing a
third partys rights and be prohibited from working with the drug or found liable for damages. Any
such restriction on access or liability for damages would have a material adverse effect on our
business, results of operations and financial condition.
18
It is our policy to require our employees and consultants, outside scientific collaborators,
sponsored researchers and other advisors who receive confidential information from us to execute
confidentiality agreements upon the commencement of employment or consulting relationships with us.
These agreements provide that all confidential information developed or made known to the
individual during the course of the individuals relationship with us is to be kept confidential
and not disclosed to third parties except in specific circumstances. The agreements provide that
all inventions conceived by an employee shall be our property. There can be no assurance, however,
that these agreements will provide meaningful protection or adequate remedies for our trade secrets
in the event of unauthorized use or disclosure of such information.
Backlog
In our partnered programs where we manufacture and supply our proprietary drug formulations,
inventory is produced and sales are made pursuant to customer purchase orders for delivery. The
volume of drug formulation actually purchased by our customers, as well as shipment schedules, are
subject to frequent revisions that reflect changes in both the customers needs and product
availability. In our partnered programs where we provide contract research services, those services
are typically provided under a work plan that is subject to frequent revisions that change based on
the development needs and status of the program. The backlog at a particular time is affected by a
number of factors, including scheduled date of manufacture and delivery and development program
status. In light of industry practice and our own experience, we do not believe that backlog as of
any particular date is indicative of future results.
Competition
Competition in the pharmaceutical and biotechnology industry is intense and characterized by
aggressive research and development and rapidly-evolving science, technology, and standards of
medical care throughout the world. We frequently compete with pharmaceutical companies and other
institutions with greater financial, research and development, marketing and sales, manufacturing
and managerial capabilities. We face competition from these companies not just in product
development but also in areas such as recruiting employees, acquiring technologies that might
enhance our ability to commercialize products, establishing relationships with certain research and
academic institutions, enrolling patients in clinical trials and seeking program partnerships and
collaborations with larger pharmaceutical companies.
Science and Technology Competition
We believe that our proprietary and partnered products will compete with others in the market
on the basis of one or more of the following parameters: efficacy, safety, ease of use and cost.
We face intense science and technology competition from a multitude of technologies seeking to
enhance the efficacy, safety and ease of use of approved drugs and new drug molecule candidates. A
number of the products in our pipeline have direct and indirect competition from large
pharmaceutical companies and biopharmaceutical companies. With our PEGylation and advanced polymer
conjugate technologies, we believe we have competitive advantages relating to factors such as
efficacy, safety, ease of use and cost for certain applications and molecules. We constantly
monitor scientific and medical developments in order to improve our current technologies, seek
licensing opportunities where appropriate, and determine the best applications for our technology
platforms.
In the fields of PEGylation and advanced polymer conjugate technologies, our competitors
include The Dow Chemical Company, Enzon Pharmaceuticals, Inc., SunBio Corporation, Mountain View
Pharmaceuticals, Inc., Neose Technologies, Inc., and NOF Corporation. Several other chemical,
biotechnology and pharmaceutical companies may also be developing PEGylation technology, advanced
polymer conjugate technology or technologies intended to deliver similar scientific and medical
benefits. Some of these companies license or provide the technology to other companies, while
others develop the technology for internal use.
Product and Program Specific Competition
Oral NKTR-118 (oral PEGylated naloxol)
There are no oral drugs approved specifically for the treatment of opioid-induced constipation
(OIC) or opioid bowel dysfunction (OBD). The only approved treatment for OIC is a subcutaneous
treatment known as methylnaltrexone bromide marketed by Wyeth. Other current therapies that are
utilized to treat OIC and OBD include over-the-counter laxatives and stool softeners, such as
docusate sodium, senna, and milk of magnesia. These therapies do not address the underlying cause
of constipation as a result of opioid use and are generally viewed as ineffective or only partially
effective to treat the symptoms of OID and OBD.
There are a number of companies developing potential products which are in various stages of
clinical development and are being evaluated for the treatment of OIC and OBD in different patient
populations. Potential competitors include Progenics Pharmaceuticals, Inc., Wyeth, Adolor
Corporation, GlaxoSmithKline, Mundipharma Int. Limited, Sucampo Pharmaceuticals, and Takeda
Pharmaceutical Company Limited.
19
NKTR-102 (PEGylated irinotecan)
There are a number of chemotherapies and cancer therapies approved today and in clinical
development for the treatment of colorectal cancer. Approved therapies for the treatment of
colorectal cancer include Eloxatin, Camptosar, Avastin, Erbitux, Vectibux, Xeloda, Adrucil, and
Wellcovorin. These therapies are only partially effective in treating the disease. There are a
number of drugs in various stages of preclinical and clinical development from companies exploring
cancer therapies or improved chemotherapeutic agents to potentially treat colorectal cancer. If
these drugs are approved, they could be competitive with NKTR-102. These include products in
development from Bristol-Myers Squibb Company, Pfizer, Inc., GlaxoSmithKline plc, Antigenics, Inc.,
F. Hoffman-La Roche Ltd, Novartis AG, Cell Therapeutics, Inc., Neopharm Inc., Meditech Research
Ltd, Alchemia Limited, Enzon Pharmaceuticals, Inc., and others.
There are also a number of chemotherapies and cancer therapies approved today and in various stages of clinical
development for ovarian, breast and cervical cancers including but not limited to: Avastin® (bevacizumab), Camptosar®
(irinotecan), Ellence® (epirubicin), Gemzar® (gemcitabine), Herceptin® (trastuzumab), Hycamtin® (topotecan),
Paraplatin® (carboplatin), and Taxol® (paclitaxel). These therapies are only partially effective in treating ovarian,
breast or cervical cancers. Major pharmaceutical or biotechnology companies with approved drugs or drugs in
development for these cancers include Bristol-Meyers Squibb, Genentech, Inc., GlaxoSmithKline plc, Pfizer, Inc., Eli
Lilly & Co., and many others.
BAY41-6551 (NKTR-061, Amikacin Inhale)
There are currently no approved drugs on the market for adjunctive treatment or prevention of
Gram-negative pneumonias in mechanically ventilated patients which are also administered via the
pulmonary route. The current standard of care includes approved intravenous antibiotics which are
partially effective for the treatment of either hospital-acquired pneumonia or
ventilator-associated pneumonia in patients on mechanical ventilators. These drugs include drugs
that fall into the categories of antipseudomonal cephalosporins, antipseudomonal carbepenems,
beta-Lactam/beta-lactamase inhibitors, antipseudomonal fluoroquinolones, such as Ciprofloxacin or
levofloxacin, and aminoglycosides, such as amikacin, gentamycin or Tobramycin.
Environment
As a manufacturer of drug products for the U.S. market, we are subject to inspections by the
FDA for compliance with cGMP and other U.S. regulatory requirements, including U.S. federal, state
and local regulations regarding environmental protection and hazardous and controlled substance
controls, among others. Environmental laws and regulations are complex, change frequently and have
tended to become more stringent over time. We have incurred, and may continue to incur, significant
expenditures to ensure we are in compliance with these laws and regulations. We would be subject to
significant penalties for failure to comply with these laws and regulations.
Employees and Consultants
As of December 31, 2008, after the completion of the Novartis asset sale transaction, we had
338 employees, of which 235 employees were engaged in research and development, commercial
operations and quality activities and 103 employees were engaged in general administration and
business development. Of the 338 employees, 290 were located in the United States and 48 were
located in India as of December 31, 2008. We have a number of employees who hold advanced degrees,
such as Ph.D.s. None of our employees are covered by a collective bargaining agreement, and we have
experienced no work stoppages. We believe that we maintain good relations with our employees.
To complement our own expert professional staff, we utilize specialists in regulatory affairs,
process engineering, manufacturing, quality assurance, clinical development and business
development. These individuals include certain of our scientific advisors as well as independent
consultants.
Available Information
Our website address is http://www.nektar.com. The information in, or that can be accessed
through, our website is not part of this annual report on Form 10-K. Our annual reports on Form
10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and amendments to those
reports are available, free of charge, on or through our website as soon as reasonably practicable
after we electronically file such material with, or furnish it to, the Securities Exchange
Commission (SEC). The public may read and copy any materials we file with the SEC at the SECs
Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. Information on the operation of
the Public Reference Room can be obtained by calling 1-800-SEC-0330. The SEC maintains an Internet
site that contains reports, proxy and information statements and other information regarding our
filings at www.sec.gov.
20
EXECUTIVE OFFICERS OF THE REGISTRANT
The following table sets forth the names, ages and positions of our executive officers as of
February 1, 2009:
|
|
|
|
|
|
|
Name |
|
Age |
|
Position |
Howard W. Robin
|
|
|
56 |
|
|
Director, President and Chief Executive Officer |
John Nicholson
|
|
|
57 |
|
|
Senior Vice President and Chief Financial Officer |
Bharatt M. Chowrira, Ph.D., J.D.
|
|
|
43 |
|
|
Senior Vice President and Chief Operating Officer |
Randall W. Moreadith, M.D., Ph.D.
|
|
|
55 |
|
|
Senior Vice President, Drug Development and Chief Development Officer |
Gil M. Labrucherie, J.D.
|
|
|
37 |
|
|
Senior Vice President, General Counsel and Secretary |
Jillian B. Thomsen
|
|
|
43 |
|
|
Vice President and Chief Accounting Officer |
Howard W. Robin has served as our Director, President and Chief Executive Officer since
January 2007 and was appointed as a member of our Board of Directors in February 2007. Mr. Robin
served as Chief Executive Officer, President and director of Sirna Therapeutics, Inc., a
clinical-stage biotechnology company pioneering RNAi-based therapies for serious diseases and
conditions, from July 2001 to November 2006 and served as their Chief Operating Officer, President
and Director from January 2001 to June 2001. From 1991 to 2001, Mr. Robin was Corporate Vice
President and General Manager at Berlex Laboratories, Inc., the U.S. pharmaceutical subsidiary of
the German pharmaceutical firm Schering AG, and, from 1987 to 1991, he served as their Vice
President of Finance and Business Development and Chief Financial Officer. From 1984 to 1987, Mr.
Robin was Director of Business Planning and Development at Berlex and was a Senior Associate with
Arthur Andersen LLP prior to joining Berlex. Since February 2006, Mr. Robin has served as a member
of the Board of Directors of Acologix, Inc., a biopharmaceutical company focused on therapeutic
compounds for the treatment of osteo-renal diseases. He received his B.S. in Accounting and Finance
from Fairleigh Dickinson University in 1974.
John Nicholson has served as our Senior Vice President and Chief Financial Officer since
December 2007. Mr. Nicholson joined the Company as Senior Vice President of Corporate Development
and Business Operations in October 2007 and was appointed Senior Vice President and Chief Financial
Officer in December 2007. Before joining Nektar, Mr. Nicholson spent 18 years in various executive
roles at Schering Berlin, Inc., the U.S. management holding company of Bayer Schering Pharma AG, a
pharmaceutical company. From 1997, he served as Schering Berlin Inc.s Vice President of Corporate
Development and Treasurer. Since 2001, he served concurrently as the President of Schering Berlin
Insurance Co., and since 2007, he served concurrently as President of Bayer Pharma Chemicals Co.
and Schering Berlin Capital Corp. Mr. Nicholson holds a B.B.A. from the University of Toledo.
Bharatt M. Chowrira, Ph.D., J.D. has served as our Senior Vice President and Chief Operating
Officer since May 2008, as well as Chairman of Nektar Therapeutics India Pvt. Ltd. From January
2007 until May 2008, Dr. Chowrira, served as Executive Director, Licensing / External Research at
Merck & Co., Inc., a global pharmaceutical company. From January 2005 through 2006, Dr. Chowrira
served as Chief Patent Counsel and Vice President, Legal Affairs of Sirna Therapeutics, Inc., a
clinical-stage biotechnology company pioneering RNAi-based therapies for serious diseases and
conditions that was acquired by Merck & Co. in January 2007. In that position, Dr. Chowrira was
responsible for all legal and business licensing activities and general corporate matters. From
January 2002 until December 2004, Dr. Chowrira was Vice President of Legal Affairs, Licensing and
Patent Counsel at Sirna Therapeutics. Dr. Chowrira joined Sirna Therapeutics (then operating as
Ribozyme Pharmaceuticals Inc.) in 1993 as a scientist. Dr. Chowrira holds a J.D. from the College
of Law at the University of Denver and a Ph.D. in Microbiology and Molecular Genetics from the
University of Vermont. Dr. Chowrira is a member of the Colorado Bar Association, admitted to
practice in California as a registered in-house counsel, and is a registered patent attorney before
the U.S. Patent and Trademark Office. He is also a member of the American Intellectual Property Law
Association, Licensing Executive Society and the Association of Corporate Counsel.
Randall W. Moreadith, M.D., Ph.D. has served as our Senior Vice President, Drug Development
and Chief Development Officer since August 2008. From January 2006 until August 2008, Dr.
Moreadith, served as Executive Vice President and Chief Medical Officer of Cardium Therapeutics, a
company developing therapeutic products and devices for cardiovascular, ischemic and related
indications. While at Cardium, he also served as Chief Medical Officer of InnerCool Therapies, a
company focused on technology to warm and cool patients, and the Tissue Repair Company, a company
focused on the development of growth factor therapeutics that promote tissue repair and
regeneration, both of which are wholly-owned subsidiaries of Cardium and were acquired by Cardium
in 2006. From August 2004 to December 2005, Dr. Moreadith served as Chief Medical Officer of
Renovis, Inc., a company that developed drugs to treat neurological diseases and disorders. He was
a cofounder of ThromboGenics Ltd., a company developing biotherapeutics for the treatment of
vascular diseases, including acute ischemic stroke, and served as ThromboGenics President and
Chief Operating Officer from
December 1998 to December 2003. From April 1996 to February 1997, Dr. Moreadith served as
Principal Medical Officer of Quintiles, Inc. and was also a co-founder of the Cardiovascular
Therapeutics Group. He received his M.D. from Duke University and his Ph.D. from Johns Hopkins
University, and was a Howard Hughes Medical Institute Postdoctoral Fellow in Genetics at Harvard
Medical School. His faculty appointments include the University of Texas Southwestern Medical
Center, where he was an Established Investigator of the American Heart Association.
21
Gil M. Labrucherie has served as our Senior Vice President, General Counsel and Secretary
since April 2007, responsible for all aspects of our legal affairs. Mr. Labrucherie served as our
Vice President, Corporate Legal from October 2005 through April 2007. From October 2000 to
September 2005, Mr. Labrucherie was Vice President of Corporate Development at E2open. While at
E2open, Mr. Labrucherie was responsible for global corporate alliances and merger and acquisition
activity. Prior to E2open, he was the Senior Director of Corporate Development at AltaVista
Company, an Internet search company, where he was responsible for strategic partnerships and
mergers and acquisitions. Mr. Labrucherie began his career as an associate in the corporate
practice of the law firm of Wilson Sonsini Goodrich & Rosati and Graham & James (DLA Piper
Rudnick). Mr. Labrucherie received his J.D. from the Berkeley Law School and a B.A. from the
University of California Davis.
Jillian B. Thomsen has served as our Vice President Finance and Chief Accounting Officer since
April 2008. Ms. Thomsen joined Nektar in March 2006 as our Vice President Finance and Corporate
Controller. Before joining Nektar, Ms. Thomsen was Vice President Finance and Deputy Corporate
Controller of Calpine Corporation from September 2002 to February 2006. Previously, Ms. Thomsen is
a certified public accountant and was a senior manager at Arthur Andersen LLP, where she worked
from 1990 to 2002, and specialized in audits of multinational consumer products, life sciences,
manufacturing and energy companies. Ms. Thomsen holds a Masters of Accountancy from the University
of Denver and a B.A. in Business Economics from Colorado College.
Item 1A. Risk Factors
We are providing the following cautionary discussion of risk factors, uncertainties and
possibly inaccurate assumptions that we believe are relevant to our business. These are factors
that, individually or in the aggregate, we think could cause our actual results to differ
materially from expected and historical results and our forward-looking statements. We note these
factors for investors as permitted by Section 21E of the Exchange Act and Section 27A of the
Securities Act. You should understand that it is not possible to predict or identify all such
factors. Consequently, you should not consider this section to be a complete discussion of all
potential risks or uncertainties that may substantially impact our business.
Risks Related to Our Business
Drug development is an inherently uncertain process and there is a high risk of failure at every
stage of development and development failures can significantly harm our business.
We have a number of proprietary product candidates and partnered product candidates in
research and development ranging from the early discovery research phase through preclinical
testing and clinical trials. Preclinical testing and clinical trials are long, expensive and a
highly uncertain processes. It will take us, or our collaborative partners, several years to
complete clinical trials. Drug development is an uncertain scientific and medical endeavor and
failure can unexpectedly occur at any stage of clinical development. Typically, there is a high
rate of attrition for product candidates in preclinical and clinical trials due to scientific
feasibility, safety, efficacy, changing standards of medical care and other variables.
Even with success in preclinical testing and clinical trials, the risk of clinical failure
remains high prior to regulatory approval.
A number of companies in the pharmaceutical and biotechnology industries have suffered
significant unforeseen setbacks in later stage clinical trials (i.e., Phase 2 or Phase 3 trials)
due to factors such as inconclusive efficacy results and adverse medical events, even after
achieving positive results in earlier trials that were satisfactory both to them and to reviewing
regulatory agencies. Although we recently announced positive preliminary Phase 2 clinical results
for NKTR-118 (oral PEGylated naloxol), there are still substantial risks associated with the future
outcome of a Phase 3 clinical trial and the regulatory review process. In addition, although
NKTR-102 (PEGylated irinotecan) continues in active Phase 2 clinical development, there remains a
significant uncertainty that this drug candidate will eventually receive regulatory approval or
this drug candidate will be a commercial success even if approved. The risk of failure is
increased for our product candidates that are based on new technologies such as the application of
our advanced polymer conjugate technology to small molecules
including without limitation NKTR-118 and NKTR-102. If our PEGylation and advanced polymer
conjugate technologies fail to generate new drug candidates with positive clinical trial results
and approved drugs, our business would be materially harmed.
22
If we are unable to establish and maintain collaboration partnerships on attractive commercial
terms, our business, results of operations and financial condition could suffer.
We intend to continue to seek partnerships with pharmaceutical and biotechnology partners to
fund a portion of our research and development expenses and develop and commercialize our product
candidates. For example, following the recent announcement of our preliminary Phase 2 clinical
results for Oral NKTR-118 (oral PEGylated naloxol), we will be actively seeking a collaboration
partner for this program. Our ability to successfully conclude a collaboration partnership for
Oral NKTR-118 on commercially favorable terms, or at all, will have a significant impact on our
business and financial position in 2009. The timing of any future partnership, as well as the
terms and conditions of the partnership, will affect our ability to benefit from the relationship.
If we are unable to fund suitable partners or to negotiate collaborative arrangements with
favorable commercial terms with respect to our existing and future product candidates or the
licensing of our technology, or if any arrangements we negotiate, or have negotiated, are
terminated, our business, results of operations and financial condition could suffer. While we may
enter new collaboration or license agreements in 2009, we currently expect revenue to decrease in
2009 as a result of the termination of our collaboration agreements with Novartis Vaccines and
Diagnostics, Inc. for Tobramycin inhalation powder (TIP) and our assignment of our rights and
obligations, other than certain royalty rights, related to the Cipro Inhale program partnered with
Schering Pharma AG. Revenue from the TIP and Cipro Inhale collaboration agreements was $13.7
million and $11.7 million, or 15% and 13%, respectively for the year ended December 31, 2008. We
will not receive any revenue related to these programs in 2009.
The commercial potential of a drug candidate in development is difficult to predict and if the
market size for a new drug is significantly smaller than we anticipated, it could significantly and
negatively impact our revenue, results of operations and financial condition.
It is very difficult to estimate the commercial potential of product candidates due to factors
such as safety and efficacy compared to other available treatments, including potential generic
drug alternatives with similar efficacy profiles, changing standards of care, third party payer
reimbursement, patient and physician preferences and the availability of competitive alternatives
that may emerge either during the long drug development process or after commercial introduction.
If due to one or more of these risks the market potential for a product candidate is lower than we
anticipated, it could significantly and negatively impact the commercial terms of any collaboration
partnership potential for such product candidate or, if we have already entered into a
collaboration for such drug candidate, the revenue potential from royalty and milestones could be
significantly diminished and would negatively impact our revenue, results of operations and
financial condition.
Our revenue is exclusively derived from our collaboration agreements, which can result in
significant fluctuation in our revenue from period to period, and our past revenue is therefore not
necessarily indicative of our future revenue.
Our revenue is derived from our collaboration agreements with partners, under which we may
receive contract research payments, milestone payments based on clinical progress, regulatory
progress or net sales achievements, royalties or manufacturing revenue. Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche represented 24%, 16%,
15%, and 14%, respectively, of our total revenue during the year ended December 31, 2008. No other
partner accounted for more than 10% of our total revenue during the year ended December 31, 2008.
Significant variations in the timing of receipt of cash payments and our recognition of revenue can
result from the nature of significant milestone payments based on the execution of new
collaboration agreements, the timing of clinical, regulatory or sales events which result in single
milestone payments and the timing and success of the commercial launch of new drugs by our
collaboration partners. The amount of our revenue derived from collaboration agreements in any
given period will depend on a number of unpredictable factors, including our ability to find and
maintain suitable collaboration partners, the timing of the negotiation and conclusion of
collaboration agreements with such partners, whether and when we or our partner achieve clinical
and sales milestones, whether the partnership is exclusive or whether we can seek other partners,
the timing of regulatory approvals and the market introduction of new drugs, as well as other
factors.
23
If our partners, on which we depend to obtain regulatory approvals for and to commercialize our
partnered products, are not successful, or if such collaborations fail, the development or
commercialization of our partnered products may be delayed or unsuccessful.
When we sign a collaborative development agreement or license agreement to develop a product
candidate with a pharmaceutical or biotechnology company, the pharmaceutical or biotechnology
company is generally expected to:
|
|
|
design and conduct large scale clinical studies; |
|
|
|
prepare and file documents necessary to obtain government approvals to sell a given
product candidate; and/or |
|
|
|
market and sell our products when and if they are approved. |
Our reliance on collaboration partners poses a number of risks to our business, including
risks that:
|
|
|
we may be unable to control whether, and the extent to which, our partners devote
sufficient resources to the development programs or commercial efforts; |
|
|
|
disputes may arise in the future with respect to the ownership of rights to
technology or intellectual property developed with partners; |
|
|
|
disagreements with partners could lead to delays in, or termination of, the research,
development or commercialization of product candidates or to litigation or arbitration; |
|
|
|
contracts with our partners may fail to provide us with significant protection, or to
be effectively enforced, in the event one of our partners fails to perform; |
|
|
|
partners have considerable discretion in electing whether to pursue the development
of any additional product candidates and may pursue alternative technologies or products
either on their own or in collaboration with our competitors; |
|
|
|
partners with marketing rights may choose to devote fewer resources to the marketing
of our partnered products than they do to products of their own development; |
|
|
|
the timing and level of resources that our partners dedicate to the development
program will affect the timing and amount of revenue we receive; |
|
|
|
partners may be unable to pay us as expected; and |
|
|
|
partners may terminate their agreements with us unilaterally for any or no reason, in
some cases with the payment of a termination fee penalty and in other cases with no
termination fee penalty. |
Given these risks, the success of our current and future partnerships is highly uncertain. We
have entered into collaborations in the past that have been subsequently terminated, such as our
collaboration with Pfizer for the development and commercialization of inhaled insulin that was
terminated by Pfizer in November 2007. If other collaborations are suspended or terminated, our
ability to commercialize certain other proposed product candidates could also be negatively
impacted. If our collaborations fail, our product development or commercialization of product
candidates could be delayed or cancelled, which would negatively impact our business, results of
operations and financial condition.
If we or our partners do not obtain regulatory approval for our product candidates on a timely
basis, if at all, or if the terms of any approval impose significant restrictions or limitations on
use, our business, results of operations and financial condition will be negatively affected.
We or our partners may not obtain regulatory approval for product candidates on a timely
basis, if at all, or the terms of any approval (which in some countries includes pricing approval)
may impose significant restrictions or limitations on use. Product candidates must undergo rigorous
animal and human testing and an extensive FDA mandated or equivalent foreign
authorities review process for safety and efficacy. This process generally takes a number of
years and requires the expenditure of substantial resources. The time required for completing
testing and obtaining approvals is uncertain, and the FDA and other U.S. and foreign regulatory
agencies have substantial discretion to terminate clinical trials, require additional testing,
delay or withhold registration and marketing approval and mandate product withdrawals, including
recalls. In addition, undesirable side effects caused by our product candidates could cause us or
regulatory authorities to interrupt, delay or halt clinical trials and could result in a more
restricted label or the delay or denial of regulatory approval by regulatory authorities.
Even if we or our partners receive regulatory approval of a product, the approval may limit
the indicated uses for which the product may be marketed. Our partnered products that have obtained
regulatory approval, and the manufacturing processes for these products, are subject to continued
review and periodic inspections by the FDA and other regulatory authorities. Discovery from such
review and inspection of previously unknown problems may result in restrictions on marketed
products or on us, including withdrawal or recall of such products from the market, suspension of
related manufacturing operations or a more restricted label. The failure to obtain timely
regulatory approval of product candidates, any product marketing limitations or a product
withdrawal would negatively impact our business, results of operations and financial condition.
24
We are a party to numerous collaboration agreements and other significant agreements, including in
connection with the Novartis Pulmonary Asset Sale, which contain complex commercial terms that
could result in disputes, litigation or indemnification liability that could adversely affect our
business, results of operations and financial condition.
We currently derive, and expect to derive in the foreseeable future, all of our revenue from
collaboration agreements with biotechnology and pharmaceutical companies. These collaboration
agreements contain complex commercial terms, including:
|
|
|
research and development performance and reimbursement obligations for our personnel
and other resources allocated to partnered product development programs; |
|
|
|
clinical and commercial manufacturing agreements, some of which are priced on an
actual cost basis for products supplied by us to our partners with complicated cost
allocation formulas and methodologies; |
|
|
|
intellectual property ownership allocation between us and our partners for
improvements and new inventions developed during the course of the partnership; |
|
|
|
royalties on end product sales based on a number of complex variables, including net
sales calculations, geography, patent life and other financial metrics; and |
|
|
|
indemnity obligations for third-party intellectual property infringement, product
liability and certain other claims. |
In addition, we have also entered into complex commercial agreements with Novartis in
connection with the sale of certain assets related to our pulmonary business, associated technology
and intellectual property to Novartis (Novartis Pulmonary Asset Sale), which was completed on
December 31, 2008. Our agreements with Novartis contain complex representations and warranties,
covenants and indemnification obligations that could result in substantial future liability and
harm our financial condition if we breach any of our agreements with Novartis or any third party
agreements impacted by this complex transaction. In addition to the asset purchase, we entered an
exclusive license agreement with Novartis Pharma pursuant to which Novartis Pharma grants back to
us an exclusive, irrevocable, perpetual, royalty-free and worldwide license under certain specific
patent rights and other related intellectual property rights necessary for us to satisfy certain
continuing contractual obligations to third parties, including in connection with development,
manufacture, sale and commercialization activities related to our partnered program for BAY41-6551
with Bayer Healthcare LLC . We also entered into a service agreement pursuant to which we have
subcontracted to Novartis certain services to be performed related to our partnered program for
BAY41-6551 and a transition services agreement pursuant to which Novartis and we will provide each
other with specified services for limited time periods following the closing of the Novartis
Pulmonary Asset Sale to facilitate the transition of the acquired assets and business from us to
Novartis.
From time to time, we have informal dispute resolution discussions with third parties
regarding the appropriate interpretation of the complex commercial terms contained in our
agreements. One or more disputes may arise in the future regarding our collaborative contracts or
the Novartis Pulmonary Asset Purchase that may ultimately result in costly litigation
and unfavorable interpretation of contract terms, which would have a material adverse impact
on our business, results of operations or financial condition.
If we or our partners are not able to manufacture drugs in quantities and at costs that are
commercially feasible, our proprietary and partnered product candidates may experience clinical
delays or constrain commercial supply which could significantly harm our business.
If we are not able to scale-up manufacturing to meet the drug quantities required to support
large clinical trials or commercial manufacturing in a timely manner or at a commercially
reasonable cost, we risk delaying our clinical trials or those of our partners and may breach
contractual obligations and incur associated damages and costs. In some cases, we may subcontract
manufacturing or other services. For instance, we entered a service agreement with Novartis
pursuant to which we subcontract to Novartis certain important services to be performed in relation
to our partnered program for BAY41-6551 with Bayer Healthcare LLC. If our subcontractors do not
dedicate adequate resources to our programs, we risk breach of our obligations to our partners.
Building and validating large scale clinical or commercial-scale manufacturing facilities and
processes, recruiting and training qualified personnel and obtaining necessary regulatory approvals
is complex, expensive and time consuming. In the past we have encountered challenges in scaling up
manufacturing to meet the requirements of large scale clinical trials without making modifications
to the drug formulation, which may cause significant delays in clinical development. Failure to
manufacture products in quantities or at costs that are commercially feasible could cause us not to
meet our supply requirements, contractual obligations or other requirements for our proprietary
product candidates and, as a result, would negatively impact our business, results of operations
and financial condition.
25
We purchase some of the raw starting material for drugs and drug candidates from a single source or
a limited number of suppliers, and the partial or complete loss of one of these suppliers could
cause production delays, clinical trial delays, substantial loss of revenue and contract liability
to third parties.
We often face very limited supply of a critical raw material that can only be obtained from a
single, or a limited number of, suppliers, which could cause production delays, clinical trial
delays, substantial lost revenue opportunity or contract liability to third parties. For example,
there are only a limited number of qualified suppliers for the raw materials included in our
PEGylation and advanced polymer conjugate drug formulations, and any interruption in supply or
failure to procure such raw materials on commercially feasible terms could harm our business by
delaying our clinical trials, impeding commercialization of approved drugs or increasing operating
loss to the extent we cannot pass on increased costs to a manufacturing customer.
The current crisis in global credit and financial markets could materially and adversely affect our
business, results of operations and financial condition.
Financial markets have experienced extreme disruption in recent months, including, among other
things, extreme volatility in security prices, severely diminished liquidity and credit
availability, rating downgrades of certain investments and declining valuations. There could be
further deterioration in credit and financial markets and confidence in economic conditions. While
we do not currently require access to credit markets to finance our operations, these economic
developments are likely to affect our business in various ways. The current tightening of credit
in financial markets may harm the ability of our partners to finance operations and they may
dedicate fewer resources to our partnered product candidates, which could result in delays in the
regulatory approval process and increase the estimated time to commercialization of our product
candidates. Since we expect that licensing deals, comprised of a combination of upfront and
contract research fees, milestones, manufacturing product sales and product royalties, will
represent the majority of our revenue in 2009, such delays could harm our business, results of
operations and financial condition. Further, our partners may be unable to continue to develop our
partnered product candidates, and some partners may terminate our collaborations. In addition, to
date all of our revenue has come from payments from partners, and it may become more difficult to
collect any payments due from our partners on a timely basis, or at all. The economic crisis may
also affect the ability of suppliers of starting materials to meet our capacity requirements or
cause them to increase the price of starting materials. We are unable to predict the likely
duration and severity of the current disruption in financial markets and adverse economic
conditions in the U.S. and other countries. As a result of the worldwide economic slowdown, it is
extremely difficult for us and our partners to forecast future sales levels based on historical
information and trends.
If any of our pending patent applications do not issue, or are deemed invalid following issuance,
we may lose valuable intellectual property protection.
The patent positions of pharmaceutical, medical device and biotechnology companies, such as
ours, are uncertain and involve complex legal and factual issues. We own approximately 80 U.S. and
approximately 335 foreign patents and a number of patent applications pending that cover various
aspects of our technologies. We have filed patent applications, and plan to file additional patent
applications, covering various aspects of our PEGylation and advanced polymer conjugate
technologies. There can be no assurance that patents that have issued will be valid and enforceable
or that patents for which we apply will issue with broad coverage, if at all. The coverage claimed
in a patent application can be significantly reduced before the patent is issued and, as a
consequence, our patent applications may result in patents with narrow coverage. Since publication
of discoveries in scientific or patent literature often lag behind the date of such discoveries, we
cannot be certain that we were the first inventor of inventions covered by our patents or patent
applications. As part of the patent application process, we may have to participate in interference
proceedings declared by the U.S. Patent and Trademark Office, which could result in substantial
cost to us, even if the eventual outcome is favorable. Further, an issued patent may undergo
further proceedings to limit its scope so as not to provide meaningful protection and any claims
that have issued, or that eventually issue, may be circumvented or otherwise invalidated. Any
attempt to enforce our patents or patent application rights could be time consuming and costly. An
adverse outcome could subject us to significant liabilities to third parties, require disputed
rights to be licensed from or to third parties or require us to cease using the technology in
dispute. Even if a patent is issued and enforceable, because development and commercialization of
pharmaceutical products can be subject to substantial delays, patents may expire early and provide
only a short period of protection, if any, following commercialization of related products.
There are many laws, regulations and judicial decisions that dictate and otherwise influence
the manner in which patent applications are filed and prosecuted and in which patents are granted
and enforced. Changes to these laws, regulations and judicial decisions are subject to influences
outside of our control and may negatively affect our business, including our ability to obtain
meaningful patent coverage or enforcement rights to any of our issued patents. New laws,
regulations and judicial decisions may be retroactive in effect, potentially reducing or
eliminating our ability to implement our patent-related strategies to these changes. Changes to
laws, regulations and judicial decisions that affect our business are often difficult or impossible
to foresee, which limits our ability to adequately adapt our patent strategies to these changes.
26
We may not be able to obtain intellectual property licenses related to the development of our
technology on a commercially reasonable basis, if at all.
Numerous pending and issued U.S. and foreign patent rights and other proprietary rights owned
by third parties relate to pharmaceutical compositions, medical devices and equipment and methods
for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict with any
certainty which, if any, patent references will be considered relevant to our or our collaborative
partners technology by authorities in the various jurisdictions where such rights exist, nor can
we predict with certainty which, if any, of these rights will or may be asserted against us by
third parties. There can be no assurance that we can obtain a license to any technology that we
determine we need on reasonable terms, if at all, or that we could develop or otherwise obtain
alternate technology. If we are required to enter into a license with a third party, our potential
economic benefit for the products subject to the license will be diminished. The failure to obtain
licenses on commercially reasonable terms, or at all, if needed, would have a material adverse
effect on us.
We rely on trade secret protection and other unpatented proprietary rights for important
proprietary technologies, and any loss of such rights could harm our business, results of
operations and financial condition.
We rely on trade secret protection for our confidential and proprietary information. No
assurance can be given that others will not independently develop substantially equivalent
confidential and proprietary information or otherwise gain access to our trade secrets or disclose
such technology, or that we can meaningfully protect our trade secrets. In addition, unpatented
proprietary rights, including trade secrets and know-how, can be difficult to protect and may lose
their value if they are independently developed by a third party or if their secrecy is lost. Any
loss of trade secret protection or other unpatented proprietary rights could harm our business,
results of operations and financial condition.
We expect to continue to incur substantial losses and negative cash flow from operations and may
not achieve or sustain profitability in the future.
In the year ended December 31, 2008, we reported net losses of $34.3 million. If and when we
achieve profitability depends upon a number of factors, including the timing and recognition of
milestone payments and license fees received, the timing of revenue under collaboration agreements,
the amount of investments we make in our proprietary product candidates and the regulatory approval
and market success of our product candidates. We may not be able to achieve and sustain
profitability.
Other factors that will affect whether we achieve and sustain profitability include our
ability, alone or together with our partners, to:
|
|
|
develop products utilizing our technologies, either independently or in collaboration
with other pharmaceutical or biotech companies; |
|
|
|
receive necessary regulatory and marketing approvals; |
|
|
|
maintain or expand manufacturing at necessary levels; |
|
|
|
achieve market acceptance of our partnered products; |
|
|
|
receive royalties on products that have been approved, marketed or submitted for
marketing approval with regulatory authorities; and |
|
|
|
maintain sufficient funds to finance our activities. |
27
If we do not generate sufficient cash flow through increased revenue or raising additional capital,
we may not be able to meet our substantial debt obligations.
As of December 31, 2008, we had cash, cash equivalents, short-term investments and investments
in marketable securities valued at approximately $379.0 million and approximately $242.6 million of
indebtedness, including approximately $215.0 million in convertible subordinated notes due
September 2012, $21.6 million in capital lease obligations and $6.0 million of other long-term
liabilities. We expect to use a substantial portion of our cash to fund our ongoing operations over
the next few years. In the three months ended December 31, 2008, we repurchased approximately
$100.0 million in par value of our 3.25% convertible subordinated notes for an aggregate purchase
price of $47.8 million.
Our substantial indebtedness has and will continue to impact us by:
|
|
|
making it more difficult to obtain additional financing; |
|
|
|
constraining our ability to react quickly in an unfavorable economic climate; |
|
|
|
constraining our stock price; and |
|
|
|
constraining our ability to invest in our proprietary product development programs. |
Currently, we are not generating positive cash flow. If we are unable to satisfy our debt
service requirements, substantial liquidity problems could result. In relation to our convertible
subordinated notes, since the market price of our common stock is significantly below the
conversion price, the holders of our outstanding convertible subordinated notes are unlikely to
convert the notes to common stock in accordance with the existing terms of the notes. If we do not
generate sufficient cash from operations to repay principal or interest on our remaining
convertible subordinated notes, or satisfy any of our other debt obligations, when due, we may have
to raise additional funds from the issuance of equity or debt securities or otherwise restructure
our obligations. Any such financing or restructuring may not be available to us on commercially
acceptable terms, if at all.
If we cannot raise additional capital, our financial condition will suffer.
We have no material credit facility or other material committed sources of capital. To the
extent operating and capital resources are insufficient to meet our future capital needs, we will
have to raise additional funds from new collaboration partnerships or the capital markets to
continue the marketing and development of our technologies and proprietary products. Such funds may
not be available on favorable terms, if at all. We may be unable to obtain suitable new
collaboration partners on attractive terms and our substantial indebtedness may limit our ability
to obtain additional capital markets financing. If adequate funds are not available on reasonable
terms, we may be required to curtail operations significantly or obtain funds by entering into
financing, supply or collaboration agreements on unattractive terms. Our inability to raise capital
could harm our business and our stock price. To the extent that additional capital is raised
through the sale of equity or convertible debt securities, the issuance of such securities would
result in dilution to our stockholders.
If government and private insurance programs do not provide reimbursement for our partnered
products or proprietary products, those products will not be widely accepted, which would have a
negative impact on our business, results of operations and financial condition.
In both domestic and foreign markets, sales of our partnered and proprietary products that
have received regulatory approval will depend in part on market acceptance among physicians and
patients, pricing approvals by government authorities and the availability of reimbursement from
third-party payers, such as government health administration authorities, managed care providers,
private health insurers and other organizations. Such third-party payers are increasingly
challenging the price and cost effectiveness of medical products and services. Therefore,
significant uncertainty exists as to the pricing approvals for, and the reimbursement status of,
newly approved healthcare products. Moreover, legislation and regulations affecting the pricing of
pharmaceuticals may change before regulatory agencies approve our proposed products for marketing
and could further limit pricing approvals for, and reimbursement of, our products from government
authorities and third-party payers. A government or third-party payer decision not to approve
pricing for, or provide adequate coverage and reimbursements of, our products would limit market
acceptance of such products.
We depend on third parties to conduct the clinical trials for our proprietary product candidates
and any failure of those parties to fulfill their obligations could harm our development and
commercialization plans.
We depend on independent clinical investigators, contract research organizations and other
third-party service providers to conduct clinical trials for our proprietary product candidates.
Though we rely heavily on these parties for successful execution of our clinical trials and are
ultimately responsible for the results of their activities, many aspects of their activities are
beyond our control. For example, we are responsible for ensuring that each of our clinical trials
is conducted in accordance with the general investigational plan and protocols for the trial, but
the independent clinical investigators may prioritize other projects over ours or communicate
issues regarding our products to us in an untimely manner. Third parties may not complete
activities on schedule or may not conduct our clinical trials in accordance with regulatory
requirements or our stated protocols. The early termination of any of our clinical trial
arrangements, the failure of third parties to comply with the regulations and requirements
governing clinical trials or our reliance on results of trials that we have not directly conducted
or monitored could hinder or delay the development, approval and commercialization of our product
candidates and would adversely affect our business, results of operations and financial condition.
28
Our manufacturing operations and those of our contract manufacturers are subject to governmental
regulatory requirements, which, if not met, would have a material adverse effect on our business,
results of operations and financial condition.
We and our contract manufacturers are required in certain cases to maintain compliance with
current good manufacturing practices (cGMP), including cGMP guidelines applicable to active
pharmaceutical ingredients, and are subject to inspections by the FDA or comparable agencies in
other jurisdictions to confirm such compliance. We anticipate periodic regulatory inspections of
our drug manufacturing facilities and the manufacturing facilities of our contract manufacturers
for compliance with applicable regulatory requirements. Any failure to follow and document our or
our contract manufacturers adherence to such cGMP regulations or satisfy other manufacturing and
product release regulatory requirements may lead to significant delays in the availability of
products for commercial use or clinical study, result in the termination or hold on a clinical
study or delay or prevent filing or approval of marketing applications for our products. Failure to
comply with applicable regulations may also result in sanctions being imposed on us, including
fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval
of our products, delays, suspension or withdrawal of approvals, license revocation, seizures or
recalls of products, operating restrictions and criminal prosecutions, any of which could harm our
business. The results of these inspections could result in costly manufacturing changes or
facility or capital equipment upgrades to satisfy the FDA that our manufacturing and quality
control procedures are in substantial compliance with cGMP. Manufacturing delays, for us or our
contract manufacturers, pending resolution of regulatory deficiencies or suspensions would have a
material adverse effect on our business, results of operations and financial condition.
Significant competition for our polymer conjugate chemistry technology platforms, our partnered and
proprietary products and product candidates could make our technologies, products or product
candidates obsolete or uncompetitive, which would negatively impact our business, results of
operations and financial condition.
Our PEGylation and advanced polymer conjugate chemistry platforms and our partnered and
proprietary products and product candidates compete with various pharmaceutical and biotechnology
companies. Competitors of our PEGylation and polymer conjugate chemistry technologies include The
Dow Chemical Company, Enzon Pharmaceuticals, Inc., SunBio Corporation, Mountain View
Pharmaceuticals, Inc., Neose Technologies, Inc., and NOF Corporation. Several other chemical,
biotechnology and pharmaceutical companies may also be developing PEGylation technologies or
technologies that have similar impact on target drug molecules. Some of these companies license or
provide the technology to other companies, while others are developing the technology for internal
use.
There are several competitors for our proprietary product candidates currently in development.
For NKTR-061 (inhaled Amikacin), the current standard of care includes several approved intravenous
antibiotics for the treatment of either hospital-acquired pneumonia or ventilator-associated
pneumonia in patients on mechanical ventilators. For NKTR-118 (PEGylated naloxol), there are
currently several alternative therapies used to address opioid-induced constipation (OIC) and
opioid-induced bowel dysfunction (OBD), including over-the-counter laxatives and stool softeners
such as docusate sodium, senna and milk of magnesia. In addition, there are a number of companies
developing potential products which are in various stages of clinical development and are being
evaluated for the treatment of OIC and OBD in different patient populations, including Adolor
Corporation, GlaxoSmithKline, Progenics Pharmaceuticals, Inc., Wyeth, Mundipharma Int. Limited,
Sucampo Pharmaceuticals and Takeda Pharmaceutical Company Limited. For NKTR-102 (PEG-irinotecan),
there are a number of approved therapies for the treatment of colorectal cancer, including
Eloxatin, Camptosar, Avastin, Erbitux, Vectibux, Xeloda, Adrucil and Wellcovorin. In addition,
there are a number of drugs in various stages of preclinical and clinical development from
companies exploring cancer therapies or improved chemotherapeutic agents to potentially treat
colorectal cancer, including, but not limited to, products in development from Bristol-Myers Squibb
Company, Pfizer, Inc., GlaxoSmithKline plc, Antigenics, Inc., F. Hoffmann-La Roche Ltd, Novartis
AG, Cell Therapeutics, Inc., Neopharm Inc., Meditech Research Ltd, Alchemia Limited, Enzon
Pharmaceuticals, Inc. and others.
There can be no assurance that we or our partners will successfully develop, obtain regulatory
approvals and commercialize next-generation or new products that will successfully compete with
those of our competitors. Many of our competitors have greater financial, research and development,
marketing and sales, manufacturing and managerial capabilities. We face competition from these
companies not just in product development but also in areas such as recruiting employees, acquiring
technologies that might enhance our ability to commercialize products, establishing relationships
with certain research and academic institutions, enrolling patients in clinical trials and seeking
program partnerships and collaborations with larger pharmaceutical companies. As a result, our
competitors may succeed in developing competing technologies, obtaining regulatory approval or
gaining market acceptance for products before we do. These developments could make our products or
technologies uncompetitive or obsolete.
29
We could be involved in legal proceedings and may incur substantial litigation costs and
liabilities that will adversely affect our business, results of operations and financial condition.
From time to time, third parties have asserted, and may in the future assert, that we or our
partners infringe their proprietary rights. The third party often bases its assertions on a claim
that its patents cover our technology. Similar assertions of infringement could be based on future
patents that may issue to third parties. In certain of our agreements with our partners, we are
obligated to indemnify and hold harmless our partners from intellectual property infringement,
product liability and certain other claims, which could cause us to incur substantial costs if we
are called upon to defend ourselves and our partners against any claims. If a third party obtains
injunctive or other equitable relief against us or our partners, they could effectively prevent us,
or our partners, from developing or commercializing, or deriving revenue from, certain products or
product candidates in the U.S. and abroad. For instance, F. Hoffmann-La Roche Ltd, to which we
license our proprietary PEGylation reagent for use in the MIRCERA product, was a party to a
significant patent infringement lawsuit brought by Amgen Inc. related to Roches proposed marketing
and sale of MIRCERA to treat chemotherapy anemia in the U.S. Amgen prevailed in this lawsuit and a
U.S. federal district court issued an injunction preventing Roche from marketing and selling
MIRCERA in the U.S. Third-party claims could also result in the award of substantial damages to be
paid by us or a
settlement resulting in significant payments to be made by us. For instance, a settlement
might require us to enter a license agreement under which we pay substantial royalties to a third
party, diminishing our future economic returns from the related product. In 2006, we entered into a
litigation settlement related to an intellectual property dispute with the University of Alabama in
Huntsville pursuant to which we paid $11.0 million and agreed to pay an additional $10.0 million in
equal $1.0 million installments over ten years ending with the last payment due on July 1, 2016. We
cannot predict with certainty the eventual outcome of any pending or future litigation. Costs
associated with such litigation, substantial damage claims, indemnification claims or royalties
paid for licenses from third parties could have a material adverse effect on our business, results
of operations and financial condition.
If product liability lawsuits are brought against us, we may incur substantial liabilities.
The manufacture, clinical testing, marketing and sale of medical products involve inherent
product liability risks. If product liability costs exceed our product liability insurance
coverage, we may incur substantial liabilities that could have a severe negative impact on our
financial position. Whether or not we are ultimately successful in any product liability
litigation, such litigation would consume substantial amounts of our financial and managerial
resources and might result in adverse publicity, all of which would impair our business.
Additionally, we may not be able to maintain our clinical trial insurance or product liability
insurance at an acceptable cost, if at all, and this insurance may not provide adequate coverage
against potential claims or losses.
Our future depends on the proper management of our current and future business operations and their
associated expenses.
Our business strategy requires us to manage our business to provide for the continued
development and potential commercialization of our proprietary and partnered product candidates.
Our strategy also calls for us to undertake increased research and development activities and to
manage an increasing number of relationships with partners and other third parties, while
simultaneously managing the expenses generated by these activities. If we are unable to manage
effectively our current operations and any growth we may experience, our business, financial
condition and results of operations may be adversely affected. If we are unable to effectively
manage our expenses, we may find it necessary to reduce our personnel-related costs through further
reductions in our workforce, which could harm our operations, employee morale and impair our
ability to retain and recruit talent. Furthermore, if adequate funds are not available, we may be
required to obtain funds through arrangements with partners or other sources that may require us to
relinquish rights to certain of our technologies or products that we would not otherwise
relinquish.
We are dependent on our management team and key technical personnel, and the loss of any key
manager or employee may impair our ability to develop our products effectively and may harm our
business, operating results and financial condition.
Our success largely depends on the continued services of our executive officers and other key
personnel. The loss of one or more members of our management team or other key employees could
seriously harm our business, operating results and financial condition. The relationships that our
key managers have cultivated within our industry make us particularly dependent upon their
continued employment with us. We are also dependent on the continued services of our technical
personnel because of the highly technical nature of our products and the regulatory approval
process. Because our executive officers and key employees are not obligated to provide us with
continued services, they could terminate their employment with us at any time without penalty. We
do not have any post-employment noncompetition agreements with any of our employees and do not
maintain key person life insurance policies on any of our executive officers or key employees.
30
Because competition for highly qualified technical personnel is intense, we may not be able to
attract and retain the personnel we need to support our operations and growth.
We must attract and retain experts in the areas of clinical testing, manufacturing,
regulatory, finance, marketing and distribution and develop additional expertise in our existing
personnel. We face intense competition from other biopharmaceutical companies, research and
academic institutions and other organizations for qualified personnel. Many of the organizations
with which we compete for qualified personnel have greater resources than we have. Because
competition for skilled personnel in our industry is intense, companies such as ours sometimes
experience high attrition rates with regard to their skilled employees. Further, in making
employment decisions, job candidates often consider the value of the stock options they are to
receive in connection with their employment. Our equity incentive plan and employee benefit plans
may not be effective in motivating or retaining our employees or attracting new employees, and
significant volatility in the price
of our stock may adversely affect our ability to attract or retain qualified personnel. If we
fail to attract new personnel or to retain and motivate our current personnel, our business and
future growth prospects could be severely harmed.
If earthquakes and other catastrophic events strike, our business may be harmed.
Our corporate headquarters, including a substantial portion of our research and development
operations, are located in the San Francisco Bay Area, a region known for seismic activity and a
potential terrorist target. In addition, we own facilities for the manufacture of products using
our PEGylation and advanced polymer conjugate technologies in Huntsville, Alabama and lease offices
in Hyderabad, India. There are no backup facilities for our manufacturing operations located in
Huntsville, Alabama. In the event of an earthquake or other natural disaster or terrorist event in
any of these locations, our ability to manufacture and supply materials for drug candidates in
development and our ability to meet our manufacturing obligations to our customers would be
significantly disrupted and our business, results of operations and financial condition would be
harmed. Our collaborative partners may also be subject to catastrophic events, such as hurricanes
and tornadoes, any of which could harm our business, results of operations and financial condition.
We have not undertaken a systematic analysis of the potential consequences to our business, results
of operations and financial condition from a major earthquake or other catastrophic event, such as
a fire, sustained loss of power, terrorist activity or other disaster, and do not have a recovery
plan for such disasters. In addition, our insurance coverage may not be sufficient to compensate us
for actual losses from any interruption of our business that may occur.
We have implemented certain anti-takeover measures, which make it more difficult to acquire us,
even though such acquisitions may be beneficial to our stockholders.
Provisions of our certificate of incorporation and bylaws, as well as provisions of Delaware
law, could make it more difficult for a third party to acquire us, even though such acquisitions
may be beneficial to our stockholders. These anti-takeover provisions include:
|
|
|
establishment of a classified board of directors such that not all members of the
board may be elected at one time; |
|
|
|
lack of a provision for cumulative voting in the election of directors, which would
otherwise allow less than a majority of stockholders to elect director candidates; |
|
|
|
the ability of our board to authorize the issuance of blank check preferred stock
to increase the number of outstanding shares and thwart a takeover attempt; |
|
|
|
prohibition on stockholder action by written consent, thereby requiring all
stockholder actions to be taken at a meeting of stockholders; |
|
|
|
establishment of advance notice requirements for nominations for election to the
board of directors or for proposing matters that can be acted upon by stockholders at
stockholder meetings; and |
|
|
|
limitations on who may call a special meeting of stockholders. |
Further, we have in place a preferred share purchase rights plan, commonly known as a poison
pill. The provisions described above, our poison pill and provisions of Delaware law relating to
business combinations with interested stockholders may discourage, delay or prevent a third party
from acquiring us. These provisions may also discourage, delay or prevent a third party from
acquiring a large portion of our securities or initiating a tender offer or proxy contest, even if
our stockholders might receive a premium for their shares in the acquisition over the then current
market prices. We also have a change of control severance benefits plan which provides for certain
cash severance, stock award acceleration and other benefits in the event our employees are
terminated (or, in some cases, resign for specified reasons) following an acquisition. This
severance plan could discourage a third party from acquiring us.
31
Risks Related to Our Securities
The price of our common stock and senior convertible debt are expected to remain volatile.
Our stock price is volatile. During the year ended December 31, 2008, based on closing bid
prices on the NASDAQ Global Select Market, our stock price ranged from $2.83 to $7.50 per share. We
expect our stock price to remain volatile. In addition, as our convertible senior notes are
convertible into shares of our common stock, volatility or depressed prices of our common stock
could have a similar effect on the trading price of our notes. Also, interest rate fluctuations can
affect the price of our convertible senior notes. A variety of factors may have a significant
effect on the market price of our common stock or notes, including:
|
|
|
announcements of data from, or material developments in, our clinical trials or those
of our competitors, including delays in clinical development, approval or launch; |
|
|
|
announcements by collaboration partners as to their plans or expectations related to
products using our technologies; |
|
|
|
announcements or terminations of collaborative relationships by us or our
competitors; |
|
|
|
fluctuations in our results of operations; |
|
|
|
developments in patent or other proprietary rights, including intellectual property
litigation or entering into intellectual property license agreements and the costs
associated with those arrangements; |
|
|
|
announcements of technological innovations or new therapeutic products that may
compete with our approved products or products under development; |
|
|
|
announcements of changes in governmental regulation affecting us or our competitors; |
|
|
|
hedging activities by purchasers of our convertible senior notes; |
|
|
|
litigation brought against us or third parties to whom we have indemnification
obligations; |
|
|
|
public concern as to the safety of drug formulations developed by us or others; and |
|
|
|
general market conditions. |
Our stockholders may be diluted, and the price of our common stock may decrease, as a result of the
exercise of outstanding stock options and warrants or the future issuances of securities.
We may issue additional common stock, preferred stock, restricted stock units or securities
convertible into or exchangeable for our common stock. Furthermore, substantially all shares of
common stock for which our outstanding stock options or warrants are exercisable are, once they
have been purchased, eligible for immediate sale in the public market. The issuance of additional
common stock, preferred stock, restricted stock units or securities convertible into or
exchangeable for our common stock or the exercise of stock options or warrants would dilute
existing investors and could adversely affect the price of our securities.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We currently lease approximately 100,000 square feet of facilities in San Carlos, California
under a capital lease which expires in 2016. The San Carlos facility is home to our administrative
headquarters, as well as research and development for our PEGylation and advanced polymer conjugate
technology operations. Until December 31, 2008, we leased approximately 230,000 additional square
feet in San Carlos, which housed our pulmonary manufacturing facility, as well as research and
development laboratories and administrative offices, under a lease which expired in 2012. This
lease was assigned to Novartis Pharmaceuticals Corporation in connection with our sale to Novartis
of certain of our pulmonary assets on December 31, 2008.
We currently own two facilities consisting of 145,000 square feet in Huntsville, Alabama,
which house laboratories as well as administrative, commercial and clinical manufacturing
facilities for our PEGylation and advanced polymer conjugate technology operations. Additionally,
we lease 18,000 square feet of facilities in Hyderabad, India under various operating leases, with
expiration dates ranging from 2009 to 2011. The Hyderabad facilities are used for research and
development activities. We are currently constructing an 80,000 square foot research and
development facility near Hyderabad, India. We expect to complete construction of this facility by
the end of 2009.
32
Item 3. Legal Proceedings
On June 30, 2006, we, our subsidiary Nektar AL, and a former officer, Milton Harris, entered
into a settlement agreement and general release with the University of Alabama Huntsville (UAH)
related to an intellectual property dispute. Under the terms of the settlement agreement, we,
Nektar AL, Mr. Harris and UAH agreed to full and complete satisfaction of all claims asserted in
the litigation in exchange for $25.0 million in cash payments. We and Mr. Harris made an initial
payment of $15.0 million on June 30, 2006, of which we paid $11.0 million and Mr. Harris paid $4.0
million. During the year ended December 31, 2006, we recorded a litigation settlement charge of
$17.7 million, which reflects the net present value of the settlement payments using an 8% annual
discount rate. We made payments of $1.0 million in June 2007 and June 2008, respectively. As of
December 31, 2008 and 2007, our accrued liability related to the UAH settlement was $6.0 million
and $6.5 million, respectively.
In addition, from time to time, we may be subject to other legal proceedings and claims in the
ordinary course of business. We are not aware of any such proceedings or claims that we believe
will have, individually or in the aggregate, a material adverse effect on our business, financial
condition or results of operations.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of our security holders in the three-month period ended
December 31, 2008.
PART II
|
|
|
Item 5. |
|
Market for Registrants Common Equity Related Stockholder Matters and Issuer Purchases of
Equity Securities |
Our common stock trades on the NASDAQ Global Select Market under the symbol NKTR. The table
below sets forth the high and low closing sales prices for our common stock as reported on the
NASDAQ Global Select Market during the periods indicated.
|
|
|
|
|
|
|
|
|
|
|
High |
|
|
Low |
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2007: |
|
|
|
|
|
|
|
|
1st Quarter |
|
$ |
15.24 |
|
|
$ |
11.20 |
|
2nd Quarter |
|
|
13.58 |
|
|
|
9.32 |
|
3rd Quarter |
|
|
9.75 |
|
|
|
7.63 |
|
4th Quarter |
|
|
8.98 |
|
|
|
5.22 |
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2008: |
|
|
|
|
|
|
|
|
1st Quarter |
|
$ |
7.50 |
|
|
$ |
6.12 |
|
2nd Quarter |
|
|
7.35 |
|
|
|
3.35 |
|
3rd Quarter |
|
|
5.36 |
|
|
|
3.10 |
|
4th Quarter |
|
|
5.97 |
|
|
|
2.83 |
|
Holders of Record
As of February 27, 2009, there were approximately 301 holders of record of our common stock.
Dividend Policy
We have never declared or paid any cash dividends on our common stock. We currently expect to
retain any future earnings for use in the operation and expansion of our business and do not
anticipate paying any cash dividends on our common stock in the foreseeable future.
There were no sales of unregistered securities and there were no common stock repurchases made
during the year ended December 31, 2008.
33
Securities Authorized for Issuance Under Equity Compensation Plans
Information regarding our equity compensation plans as of December 31, 2008 is disclosed in
Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters of this Annual Report on Form 10-K and is incorporated herein by reference from our proxy
statement for our 2009 annual meeting of stockholders to be filed with the SEC pursuant to
Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual
Report on Form 10-K.
Performance Measurement Comparison
The material in this section is being furnished and shall not be deemed filed with the SEC
for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that
section, nor shall the material in this section be deemed to be incorporated by reference in any
registration statement or other document filed with the SEC under the Securities Act or the
Exchange Act, except as otherwise expressly stated in such filing.
The following graph compares, for the five year period ended December 31, 2008, the cumulative
total stockholder return (change in stock price plus reinvested dividends) of our common stock with
(i) the NASDAQ Composite Index, (ii) the NASDAQ Pharmaceutical Index, (iii) the RGD SmallCap
Pharmaceutical Index, (iv) the NASDAQ Biotechnology Index and (v) the RDG SmallCap Biotechnology
Index. Measurement points are the last trading day of each of our fiscal years ended December 31,
2003, December 31, 2004, December 31, 2005, December 31, 2006, December 31, 2007 and December 31,
2008. The graph assumes that $100 was invested on December 31, 2003 in the common stock of the
Company, the NASDAQ Composite Index, the Nasdaq Pharmaceutical Index, the RGD SmallCap
Pharmaceutical Index, the NASDAQ Biotechnology Index and the RDG SmallCap Biotechnology Index and
assumes reinvestment of any dividends. The stock price performance in the graph is not intended to
forecast or indicate future stock price performance.
34
Item 6. Selected Financial Data
SELECTED CONSOLIDATED FINANCIAL INFORMATION
(In thousands, except per share information)
The selected consolidated financial data set forth below should be read together with the
consolidated financial statements and related notes, Managements Discussion and Analysis of
Financial Condition and Results of Operations, and the other information contained herein.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and royalties (1) |
|
$ |
41,255 |
|
|
$ |
180,755 |
|
|
$ |
153,556 |
|
|
$ |
29,366 |
|
|
$ |
25,085 |
|
Collaboration and other (2) |
|
|
48,930 |
|
|
|
92,272 |
|
|
|
64,162 |
|
|
|
96,913 |
|
|
|
89,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
90,185 |
|
|
|
273,027 |
|
|
|
217, 718 |
|
|
|
126,279 |
|
|
|
114,270 |
|
Total operating costs and expenses (3)(4) |
|
|
172,837 |
|
|
|
309,175 |
|
|
|
376,948 |
|
|
|
308,912 |
|
|
|
188,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(82,652 |
) |
|
|
(36,148 |
) |
|
|
(159,230 |
) |
|
|
(182,633 |
) |
|
|
(73,942 |
) |
Gain (loss) on debt extinguishment |
|
|
50,149 |
|
|
|
|
|
|
|
|
|
|
|
(303 |
) |
|
|
(9,258 |
) |
Interest and other income (expense), net |
|
|
(2,639 |
) |
|
|
4,696 |
|
|
|
5,297 |
|
|
|
(2,312 |
) |
|
|
(18,849 |
) |
Provision (benefit) for income taxes |
|
|
(806 |
) |
|
|
1,309 |
|
|
|
828 |
|
|
|
(137 |
) |
|
|
(163 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(34,336 |
) |
|
$ |
(32,761 |
) |
|
$ |
(154,761 |
) |
|
$ |
(185,111 |
) |
|
$ |
(101,886 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share (5) |
|
$ |
(.37 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.72 |
) |
|
$ |
(2.15 |
) |
|
$ |
(1.30 |
) |
Shares used in computing basic and
diluted net loss per share (5) |
|
|
92,407 |
|
|
|
91,876 |
|
|
|
89,789 |
|
|
|
85,915 |
|
|
|
78,461 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
investments |
|
$ |
378,994 |
|
|
$ |
482,353 |
|
|
$ |
466,977 |
|
|
$ |
566,423 |
|
|
$ |
418,740 |
|
Working capital |
|
$ |
337,846 |
|
|
$ |
425,191 |
|
|
$ |
369,457 |
|
|
$ |
450,248 |
|
|
$ |
223,880 |
|
Total assets |
|
$ |
560,536 |
|
|
$ |
725,103 |
|
|
$ |
768,177 |
|
|
$ |
858,554 |
|
|
$ |
744,921 |
|
Deferred revenue |
|
$ |
65,577 |
|
|
$ |
80,969 |
|
|
$ |
40,106 |
|
|
$ |
23,861 |
|
|
$ |
31,021 |
|
Convertible subordinated notes |
|
$ |
214,955 |
|
|
$ |
315,000 |
|
|
$ |
417,653 |
|
|
$ |
417,653 |
|
|
$ |
173,949 |
|
Other long-term liabilities |
|
$ |
25,585 |
|
|
$ |
27,543 |
|
|
$ |
29,189 |
|
|
$ |
27,598 |
|
|
$ |
36,250 |
|
Accumulated deficit |
|
$ |
(1,124,090 |
) |
|
$ |
(1,089,754 |
) |
|
$ |
(1,056,993 |
) |
|
$ |
(902,232 |
) |
|
$ |
(717,121 |
) |
Total stockholders equity |
|
$ |
190,154 |
|
|
$ |
214,439 |
|
|
$ |
227, 060 |
|
|
$ |
326,811 |
|
|
$ |
467,342 |
|
|
|
|
(1) |
|
2006 and 2007 product sales and royalties include commercial manufacturing revenue from
Exubera bulk dry powder insulin and Exubera inhalers. |
|
(2) |
|
2007, 2006, and 2005 collaboration and other revenue included Exubera commercialization
readiness revenue. |
|
(3) |
|
We changed our method of accounting for stock based compensation on January 1, 2006 in
connection with the adoption of SFAS No. 123R, Share-Based Payment. |
|
(4) |
|
Operating costs and expenses includes the Gain on sale of pulmonary assets of $69.6 million
in 2008 and the Gain on termination of collaborative agreements, net of $79.2 million in 2007. |
|
(5) |
|
Basic and diluted net loss per share is based upon the weighted average number of common
shares outstanding. |
35
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those discussed here. Factors that
could cause or contribute to such differences include, but are not limited to, those discussed in
this section as well as factors described in Part I, Item 1ARisk Factors.
Overview
Strategic Direction of Our Business
We are a clinical-stage biopharmaceutical company developing a pipeline of drug candidates
that utilize our PEGylation and advanced polymer conjugate technology platforms to improve the
therapeutic benefits of drugs. Our proprietary product pipeline is comprised of drug candidates
across a number of therapeutic areas, including oncology, pain, anti-infectives and immunology. We
create our innovative product candidates by using our proprietary chemistry platform to modify the
chemical structure of drugs using unique polymer conjugates. Additionally, we may utilize
established pharmacologic targets to engineer a new drug candidate relying on a combination of the
known properties of these targets and the attributes of our customized polymer chemistry. Our drug
candidates are designed to correct deficiencies in the pharmacokinetics, half-life, oral
bioavailability, metabolism or distribution of drugs to improve their therapeutic efficacy.
During 2009, we expect to continue to make substantial investments to advance our pipeline of
drug candidates from early stage discovery research through clinical
development. On March 2, 2009, we
announced that we were terminating our Phase 2 clinical trial for Oral NKTR-118 (oral PEGylated
naloxol) as a result of positive preliminary results. We also have several Phase 2 clinical trials
for NKTR-102 (PEGylated irinotecan) directed at a number of different indications in the oncology
therapeutic area already underway or scheduled to begin during 2009. In addition, on February 17,
2009, we announced that we had dosed the first patient in a Phase 1 clinical trial for NKTR-105
(PEGylated docetaxel) for patients with refractory solid tumors. We also have several other
products in the early discovery or preclinical stage that we are preparing to move into clinical
development or will be moving into clinical development in 2009.
Our focus on research and clinical development requires substantial investments that continue
to increase as we advance each drug candidate through the development cycle. While we believe that
our strategy has the potential to create significant value if one or more of our drug candidates
demonstrates positive clinical results and/or receives regulatory approval in one or more major
markets, drug development is an inherently uncertain process and there is a high risk of failure at
every stage prior to approval and clinical results are very difficult to predict. Clinical
development success and failures can have an unpredictable and disproportionate positive or
negative impact on our scientific and medical prospects, financial prospects, financial condition,
and market value.
We intend to decide on a product-by-product basis whether we wish to continue development into
Phase 3 pivotal clinical trials and commercialize products on our own, or seek a partner, or pursue
a combination of these approaches. Following completion of Phase 2 development, or earlier in the
development cycle in certain circumstances, we will generally be seeking collaborations with one or
more biotechnology or pharmaceutical companies to conduct Phase 3 clinical development, to be
responsible for the regulatory approval process and, if such drug candidate is approved, to market
and sell the drug in one or more world markets. The commercial terms of such future
collaborations, if any, including, without limitation, up-front payments, development milestone
payments, and royalty rates, will be critical to the future prospects of our business and financial
condition. In particular, our ability to successfully conclude a new collaboration for Oral
NKTR-118 on commercially favorable terms (or at all), will have a significant impact on our financial position
and business prospects in 2009.
We also have a number of existing license and collaboration agreements with third parties who
have licensed our proprietary technologies for drugs that have either received regulatory approval
in one or more markets or drug candidates that are still in the clinical development stage. For
example, the future clinical and commercial success of Bayers Amikacin Inhale (BAY41-6551 or
NKTR-061), UCBs CIMZIA, Roches MIRCERA and Affymaxs Hematide, among others, will together have
a material impact on our long-term revenue prospects, as will the success of Bayers Cipro Inhale
program, in relation to which we have certain royalty rights. Because drug development and
commercialization is subject to a number of risks and uncertainties, there is a risk that our
future revenue from one or more of these agreements will be less than we anticipate.
36
We Exited the Inhaled Insulin Drug Programs in 2008
In 1995, we entered into a collaborative development and licensing agreement with Pfizer to
develop and market dry powder inhaled insulin (Exubera) for patients with diabetes. In 2006 and
2007, we entered into a series of interim letter agreements with Pfizer to develop a next generation form of dry powder inhaled insulin (NGI).
In January 2006, Exubera received marketing approval in the U.S. and EU. Under the collaborative
development and licensing agreement, Pfizer had sole responsibility for marketing and selling
Exubera. We performed all of the manufacturing of the bulk dry powder insulin, and through our
third party contract manufacturers Bespak Europe Ltd. and Tech Group North America, Inc., we
supplied Pfizer with the Exubera inhalers. Our total revenue from Pfizer was nil, $189.1 million,
and $139.9 million, representing 0%, 69%, and 64% of total revenue, for the years ended December
31, 2008, 2007, and 2006, respectively.
On October 18, 2007, Pfizer announced that it was exiting the Exubera and inhaled insulin
development and gave notice of termination under our collaborative development and licensing
agreement. On November 9, 2007, we entered into a termination agreement and mutual release with
Pfizer. Under this agreement we received a one-time payment of $135.0 million from Pfizer in
November 2007 in satisfaction of all outstanding contractual obligations under our then-existing
agreements relating to Exubera and NGI. All agreements between Pfizer and us related to Exubera
and NGI, other than the termination agreement and mutual release and a related interim Exubera
manufacturing maintenance letter, terminated on November 9, 2007. In February 2008, we entered
into a manufacturing termination agreement with Bespak and Tech Group pursuant to which we paid an
aggregate of $39.9 million in satisfaction of outstanding accounts payable and termination costs
and expenses that were due to the contract manufacturers under the Exubera inhaler contract
manufacturing agreement. We also entered into a maintenance agreement with both Pfizer and Tech
Group to preserve key personnel and manufacturing capacity to support potential future Exubera
manufacturing if we were successful in finding a new partner for the inhaled insulin program.
On April 9, 2008, we announced that we had ceased all negotiations with potential partners for
Exubera and NGI as a result of new data analysis from ongoing clinical trials conducted by Pfizer
which indicated an increase in the number of new cases of lung cancer in Exubera patients who were
former smokers as compared to patients in the control group who were not former smokers. In April
2008, we ceased all spending associated with maintaining Exubera manufacturing capacity and any
further NGI development, including, but not limited to, terminating the Exubera manufacturing
capacity maintenance arrangements with Pfizer and Tech Group.
We Completed the Sale of Certain Pulmonary Assets and Operations at the End of 2008
On December 31, 2008, we completed the sale of certain assets related to our pulmonary
business, associated technology and intellectual property to Novartis Pharma AG and Novartis
Pharmaceuticals Corporation (together referred to as Novartis) for a purchase price of $115.0
million in cash (Novartis Pulmonary Asset Sale). Pursuant to the asset purchase agreement entered
between Novartis and us, we transferred to Novartis assets and obligations which include certain
dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment
and manufacturing facility lease obligations, certain intellectual property and manufacturing
methods and associated information systems related to the pulmonary business, and certain other
interests in two private companies, and Novartis hired approximately 140 of our pulmonary
personnel. In addition, we assigned our rights and obligations, other than certain royalty rights,
related to the Cipro Inhale partnered with Bayer Schering Pharma AG to Novartis, and terminated our
collaborative research, development, and commercialization agreement related to the Tobramycin
inhalation powder (TIP) program with Novartis Vaccines and Diagnostics, Inc. Pursuant to the asset
purchase agreement, we retain our rights and obligations under our co-development, license and
co-promotion agreement with Bayer Healthcare LLC related to BAY41-6551 (NKTR-061, Amikacin Inhale),
our development program related to NKTR-063 (Inhaled Vancomycin) and intellectual property specific
to inhaled insulin. Although we completed the Novartis Pulmonary Asset Sale on December 31, 2008,
we will pay approximately $4.4 million in related transaction costs in the three months ended March
31, 2009, including legal fees, investment banker fees, and other costs.
Following the completion of the Novartis transaction, we expect our contract research revenue
and total revenue to significantly decline in 2009 due to the termination of the inhaled TIP
collaboration agreement with Novartis Vaccines and Diagnostics, Inc. and our assignment and
transfer of our inhaled Cipro Inhale collaboration agreement with Bayer Schering Pharma AG to
Novartis. Our collaboration revenue related to TIP and Cipro Inhale was $13.7 million and $11.7
million, or 15% and 13%, respectively, of our total revenue for the year ended December 31, 2008.
We will not receive any revenue from these programs in 2009. However, also following the Novartis
transaction, we will no longer incur expenses from the approximately 140 pulmonary personnel and
the dedicated pulmonary manufacturing facility, as well as certain other costs related to the
assets and obligations, transferred to Novartis. The only future research and development
obligations associated with the pulmonary assets that we retained in relation to the Novartis
transaction relate to BAY41-66551 and NKTR-063. Under our collaboration agreement with Bayer
Healthcare LLC, we are responsible for the completion of final device development and have a
reimbursement obligation for up to $10.0 million of Phase 3 development costs incurred by Bayer
Healthcare LLC.
37
Key Developments and Trends in Liquidity and Capital Resources
At December 31, 2008, we had approximately $379.0 million in cash and cash equivalents and
$242.6 million in indebtedness. In the three months ended December 31, 2008, we repurchased
approximately $100.0 million in par value of our 3.25% convertible subordinated notes for an
aggregate purchase price of $47.8 million. We may from time to time purchase or retire additional
convertible subordinated notes through cash purchase or exchanges for other securities of the
Company in open market or privately negotiated transactions, depending on, among other factors, our
levels of available cash and the price at which such convertible notes are available for purchase.
We will evaluate such transactions, if any, in light of then-existing market conditions. These
transactions, individually or in the aggregate, may be material to our business.
We have financed our operations primarily through revenue from product sales and royalties and
research and development contracts and public and private placements of debt and equity. To date
we have incurred substantial debt as a result of our issuances of subordinated notes that are
convertible into our common stock. Our substantial debt, the market price of our securities, and
the general economic climate, among other factors, could have material consequences for our
financial condition and could affect our sources of short-term and long-term funding. Our ability
to meet our ongoing operating expenses and repay our outstanding indebtedness is dependent upon our
and our partners ability to successfully complete clinical development of, obtain regulatory
approvals for and successfully commercialize new drugs. Even if we or our partners are successful,
we may require additional capital to continue to fund our operations and repay our debt obligations
as they become due. There can be no assurance that additional funds, if and when required, will be
available to us on favorable terms, if at all.
For the year ended December 31, 2008, net cash used for our operating activities was $145.8
million. During the year ended December 31, 2008, we made the following payments, among others:
(i) $39.9 million to Bespak Europe Ltd. and Tech Group as payment for termination amounts due under
our Exubera inhaler manufacturing and supply agreement with those companies, all of which was
recorded as an expense in 2007, (ii) $6.8 million to maintain Exubera manufacturing capacity
through April 2008 and (iii) $5.4 million for severance, employee benefits and outplacement
services in connection with our workforce reduction plans. We do not anticipate incurring any
costs in 2009 associated with inhaled insulin.
Our substantial investment in our preclinical and clinical research and any potential new
licensing or partnership agreements, if any, will be the key drivers of our results of operations
and financial position during 2009. One of our collaboration partners has a one-time license
extension option exercisable in December 2009. If this partner elects to exercise this license
extension option right, we will receive a cash payment of $31.0 million in December 2009.
Results of Operations
Years Ended December 31, 2008, 2007, and 2006
Revenue (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Product sales and
royalties |
|
$ |
41,255 |
|
|
$ |
180,755 |
|
|
$ |
153,556 |
|
|
$ |
(139,500 |
) |
|
$ |
27,199 |
|
|
|
(77 |
)% |
|
|
18 |
% |
Collaboration and other |
|
|
48,930 |
|
|
|
92,272 |
|
|
|
64,162 |
|
|
|
(43,342 |
) |
|
|
28,110 |
|
|
|
(47 |
)% |
|
|
44 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
|
$ |
(182,842 |
) |
|
$ |
55,309 |
|
|
|
(67 |
)% |
|
|
25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the year ended December 31, 2008, the decrease in total revenue from the year ended
December 31, 2007 was primarily attributable to the termination of our collaboration agreements
with Pfizer related to Exubera and NGI, which accounted for $182.4 million, or 67%, of our total
revenue during the year ended December 31, 2007. We had no revenue from Pfizer related to Exubera
or NGI for the year ended December 31, 2008. Four of our customers, Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche represented 24%, 16%,
15%, and 14%, respectively, of our total revenue during the year ended December 31, 2008.
In connection with the completion of the Novartis Pulmonary Asset Sale on December 31, 2008,
our collaboration agreement with Novartis Vaccines and Diagnostics, Inc. for TIP was terminated and
our collaboration agreement with Bayer Schering Pharma AG for Cipro Inhale was assigned to
Novartis. Collaboration revenue related to TIP and Cipro Inhale was $13.7 million and $11.7
million, or 15% and 13%, of our total revenue for the year ended December 31, 2008. We will not
receive any revenue related to these programs in 2009. While we may enter new collaboration or
license agreements in 2009,
we expect revenue to decrease in 2009 as a result of the TIP agreement termination, the
assignment of the Cipro Inhale agreement, and lower product sales volumes required by our licensing
partners. In addition, if our collaboration partner elects not to exercise its one-time license
extension option in December 2009 and pay us the one-time $31.0 million license fee for such
option, our revenue would significantly decrease in 2009 as compared to the year ended December 31,
2008.
38
Product sales and royalties
For the year ended December 31, 2007, Exubera product sales to Pfizer accounted for $132.9
million of our total revenue. We had no revenue from Pfizer related to Exubera for the year ended
December 31, 2008. Non-Exubera product sales and royalties decreased by approximately $6.6 million,
or 14%, for the year ended December 31, 2008, compared to the year ended December 31, 2007. The
decrease in non-Exubera product sales and royalties is primarily attributable to the November 30,
2007 sale of Aerogen Ireland Ltd., one of our former subsidiaries that manufactured and supplied
general purpose nebulizer devices, which accounted for $5.5 million in revenue for the year ended
December 31, 2007.
Product sales and royalties increased 18% to $180.8 million for the year ended December 31,
2007 as compared to the year ended December 31, 2006. Exubera product sales to Pfizer increased by
approximately $32.0 million during the year ended December 31, 2007 as compared to the year ended
December 31, 2006. Exubera commercial sales began in January 2006. During the year ended December
31, 2006, we deferred recognition of all Exubera product sales until Pfizers contractual 60-day
right of return period lapsed. As a result, as of December 31, 2006, we deferred $22.9 million in
Exubera product sales and we recognized ten months of product shipments in revenue. In January
2007, we began estimating product warranty returns and recognizing Exubera product sales upon
shipment. During the year ended December 31, 2007, we recognized product sales through November 9,
2007, when our collaboration agreements with Pfizer terminated, as well as the revenue deferred at
December 31, 2006.
Royalty revenues were $3.5 million, $3.7 million, and $9.2 million for the years ended
December 31, 2008, 2007, and 2006, respectively.
Collaboration and other revenue
Collaboration and other revenue includes reimbursed research and development expenses,
amortization of deferred up-front signing and milestone payments received from our collaboration
partners, and intellectual property license fee revenue. Collaboration revenue fluctuates from year
to year, and therefore future collaboration revenue cannot be predicted accurately. The level of
collaboration and other revenues depends in part upon the continuation of existing collaborations,
signing of new collaborations, the stage of program development, and the achievement of milestones.
For the year ended December 31, 2007, collaboration and other revenue from Pfizer related to
Exubera and NGI accounted for $49.5 million of our collaboration and other revenue. We had no
collaboration and other revenue from Pfizer related to Exubera or NGI for the year ended December
31, 2008. The increase in non-Pfizer collaboration and other revenue of $6.1 million during the
year ended December 31, 2008 compared to the year ended December 31, 2007 is primarily attributable
to a new intellectual property license agreement we entered into with F. Hoffmann-La Roche Ltd. For
the year ended December 31, 2008, we have recognized increased collaboration and other revenue from
Bayer (including Bayer Healthcare LLC and Bayer Schering Pharma AG) of $12.3 million under our
collaboration agreements for BAY41-6551 (NKTR-061, Amikacin Inhale) and Cipro Inhale. These
increases are offset by decreased collaboration and other revenue of $3.3 million from Novartis
Vaccines and Diagnostics, Inc. under our collaboration agreement for TIP and of $3.7 million from
Solvay Pharmaceuticals, Inc. and Zelos Therapeutics Inc. following the termination of those
collaboration agreements in 2008.
The increase in collaboration and other revenue for the year ended December 31, 2007 compared
to the year ended December 31, 2006 is primarily attributable to increased revenue from Pfizer of
$15.8 million, which includes recognition of $24.6 million in NGI up-front fees upon termination of
the Pfizer Agreements. Additionally, collaboration and other revenue from Novartis increased by
$8.5 million under our collaboration agreement for TIP, and Bayer (including Bayer Healthcare LLC
and Bayer Schering Pharma AG) increased by $3.2 million, and $1.3 million, respectively, under our
collaboration agreements for Cipro Inhale and BAY41-6551, respectively. These increases in
collaboration and other revenue were partially offset by decreased revenue from Zelos of $4.2
million under our collaboration agreement to develop Ostabolin-C.
The timing and future success of our drug development programs and those of our collaboration
partners are subject to a number of risks and uncertainties. See Part I, Item 1ARisk Factors
for discussion of the risks associated with our partnered research and development programs.
39
Revenue by geography
Revenue by geographic area is based on the shipping locations of our customers. The following
table sets forth revenue by geographic area (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
United States |
|
$ |
30,800 |
|
|
$ |
212,990 |
|
|
$ |
182,959 |
|
European countries |
|
|
59,385 |
|
|
|
60,037 |
|
|
|
33,471 |
|
All other countries |
|
|
|
|
|
|
|
|
|
|
1,288 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
|
|
|
|
|
|
|
|
|
|
The decrease in revenue attributable to the United States for the year ended December 31, 2008
compared to the year ended December 31, 2007 is primarily attributable to our receipt of no revenue
from Pfizer related to Exubera for the year ended December 31, 2008.
The increase in revenue attributable to the United States for the year ended December 31, 2007
compared to the year ended December 31, 2006 is primarily attributable to the increase in revenue
from Pfizer related to Exubera for the year ended December 31, 2007. The increase in revenue
attributable to European countries for the year ended December 31, 2007 compared to the year ended
December 31, 2006 is primarily due to the increase in revenue from Novartis under our collaborative
agreement for TIP and from Bayer (including Bayer Healthcare LLC and Bayer Schering Pharma AG)
under our collaborative agreements for BAY41-6551 and Cipro Inhale.
Cost of goods sold (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Cost of goods sold |
|
$ |
28,216 |
|
|
$ |
137,696 |
|
|
$ |
113,921 |
|
|
$ |
(109,480 |
) |
|
$ |
23,775 |
|
|
|
(80 |
)% |
|
|
21 |
% |
Product gross margin |
|
|
13,039 |
|
|
|
43,059 |
|
|
|
39,635 |
|
|
|
(30,020 |
) |
|
|
3,424 |
|
|
|
(70 |
)% |
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product gross
margin % |
|
|
32 |
% |
|
|
24 |
% |
|
|
26 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in cost of goods sold and product gross margin during the year ended December 31,
2008 compared to the year ended December 31, 2007 was primarily due to the termination of our
agreements with Pfizer related to Exubera. During the year ended December 31, 2007, Exubera cost
of goods sold totaled $103.6 million and Exubera gross margin totaled $29.3 million. The increase
in product gross margin percentage is attributable to the change in product mix with our product
sales based on our PEGylation and advanced polymer conjugate technologies which have a relatively
higher gross margin.
Cost of goods sold during the year ended December 31, 2007 includes Exubera manufacturing
costs through the November 9, 2007 termination of the Pfizer agreements. Costs related to our
Exubera manufacturing operations after November 9, 2007 are included in other cost of revenue.
The increase in cost of goods sold and product gross margin during the year ended December 31,
2007 compared to the year ended December 31, 2006 is consistent with the proportionate increase in
Exubera product sales, which contributed $19.5 million to our product gross margin during the year
ended December 31, 2006. The decrease in gross margin percentage during the year ended December 31,
2007 compared to the year ended December 31, 2006 is primarily attributable to product mix, the
terms of our cost plus manufacturing arrangement with Pfizer, and the decline in royalty revenue of
$5.5 million during 2007.
We expect Cost of goods sold and Product gross margin to decline in 2009 as compared to the
year ended December 31, 2008 in connection with the lower manufacturing requirements forecasted by
our licensing partners.
40
Cost of Workforce Reduction Plans (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Cost of goods sold, net of change
in inventory |
|
$ |
148 |
|
|
$ |
974 |
|
|
$ |
|
|
|
$ |
(826 |
) |
|
$ |
974 |
|
|
|
(85 |
%) |
|
|
n/a |
|
Other cost of revenue |
|
|
1,221 |
|
|
|
|
|
|
|
|
|
|
|
1,221 |
|
|
|
|
|
|
|
n/a |
|
|
|
n/a |
|
Research and development |
|
|
3,087 |
|
|
|
5,791 |
|
|
|
|
|
|
|
(2,704 |
) |
|
|
5,791 |
|
|
|
(47 |
%) |
|
|
n/a |
|
General and administrative |
|
|
517 |
|
|
|
1,617 |
|
|
|
|
|
|
|
(1,100 |
) |
|
|
1,617 |
|
|
|
(68 |
%) |
|
|
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of workforce reduction plans |
|
$ |
4,973 |
|
|
$ |
8,382 |
|
|
$ |
|
|
|
$ |
(3,409 |
) |
|
$ |
8,382 |
|
|
|
(41 |
%) |
|
|
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We executed workforce reduction plans in May 2007 (2007 Plan) and February 2008 (2008 Plan)
designed to streamline the company, consolidate corporate functions, and strengthen decision
making. The total cost of the 2007 Plan was $8.4 million and the total cost of the 2008 Plan was
$5.0 million, comprised of cash payments for severance, medical insurance and outplacement
services. Both plans were substantially complete at December 31, 2008. We have already begun to
realize the cost savings related to these two plans, as discussed further under Research and
development and General and administrative below.
Other cost of revenue (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Other cost of revenue |
|
$ |
6,821 |
|
|
$ |
9,821 |
|
|
$ |
4,168 |
|
|
$ |
(3,000 |
) |
|
$ |
(5,653 |
) |
|
|
(31 |
%) |
|
|
>(100 |
%) |
Other cost of revenue includes the idle Exubera manufacturing capacity costs and Exubera
commercialization readiness costs that were incurred by us prior to the termination of all of our
inhaled insulin programs in April 2008.
Idle Exubera manufacturing capacity costs includes the costs of maintaining our manufacturing
operating capacity after the termination of the Pfizer agreements on November 9, 2007 through the
termination of our inhaled insulin programs on April 9, 2008. Idle Exubera manufacturing capacity
costs include amounts payable to Pfizer and Tech Group under interim manufacturing capacity
maintenance agreements and an allocation of manufacturing costs shared between commercial
operations and research and development, including employee compensation and benefits, rent, and
utilities. Idle Exubera manufacturing costs were $6.8 million, $6.3 million, and nil for the year
ended December 31, 2008, 2007, and 2006, respectively.
Exubera commercialization readiness costs were start-up manufacturing costs we incurred in our
Exubera inhalation bulk powder manufacturing facility and our Exubera inhaler device third party
contract manufacturing locations in preparation for commercial scale manufacturing in early 2006.
Exubera commercialization readiness costs were nil, $3.5 million, and $4.2 million for the year
ended December 31, 2008, 2007, and 2006, respectively.
We do not expect to incur any additional idle Exubera manufacturing capacity or Exubera
commercialization readiness costs.
Research and development (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Research &
development |
|
$ |
154,417 |
|
|
$ |
153,575 |
|
|
$ |
149,381 |
|
|
$ |
842 |
|
|
$ |
4,194 |
|
|
|
1 |
% |
|
|
3 |
% |
Research and development expenses consist primarily of personnel costs, including salaries,
benefits and stock-based compensation, clinical studies performed by contract research
organizations (CROs), materials and supplies, licenses and fees and overhead allocations consisting
of various support and facilities related costs. Our research and development activities are
broken down between proprietary and partnered drug development programs. Under the terms of our
collaboration agreements, we are generally reimbursed for research and development activities and
will receive milestones and royalties on commercial sales of the drug.
41
Research and development costs include certain allocations of resources shared across our
research and development programs, including facilities, manufacturing quality personnel and other
shared resources. We have generally allocated these shared costs based on personnel hours. The
costs incurred in connection with our research and development programs, is as follows (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical |
|
Years ended December 31, |
|
|
|
Study
Status(1) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
NKTR-102 (PEGylated irinotecan) |
|
Phase 2 |
|
$ |
24.2 |
|
|
$ |
12.7 |
|
|
$ |
2.7 |
|
NKTR-118 (oral PEGylated naloxol) |
|
Phase 2 |
|
|
24.6 |
|
|
|
12.9 |
|
|
|
5.5 |
|
Tobramycin inhalation powder (TIP)(2) |
|
Phase 2 |
|
|
19.7 |
|
|
|
16.3 |
|
|
|
12.8 |
|
BAY41-6551 (NKTR-061, Amikacin Inhale) (3) |
|
Phase 2 |
|
|
17.7 |
|
|
|
15.2 |
|
|
|
13.6 |
|
Cipro Inhale(4) |
|
Phase 2 |
|
|
11.4 |
|
|
|
8.3 |
|
|
|
5.9 |
|
NKTR-105 (PEGylated docetaxel) |
|
Phase 1 |
|
|
8.4 |
|
|
|
0.4 |
|
|
|
|
|
Inhaled Insulin(5) |
|
Discontinued |
|
|
3.5 |
|
|
|
37.6 |
|
|
|
39.5 |
|
NKTR-063 (Inhaled Vancomycin) |
|
Phase 1 |
|
|
2.3 |
|
|
|
|
|
|
|
|
|
Other PEGylation product candidates |
|
Various |
|
|
21.0 |
|
|
|
16.2 |
|
|
|
12.4 |
|
Other pulmonary product candidates(6) |
|
Various |
|
|
15.7 |
|
|
|
28.2 |
|
|
|
54.0 |
|
Other(7) |
|
|
|
|
5.9 |
|
|
|
5.8 |
|
|
|
3.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
$ |
154.4 |
|
|
$ |
153.6 |
|
|
$ |
149.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Clinical Study Status definitions are provided in the chart found in Part I, Item 1. Business |
|
(2) |
|
The collaboration agreement with Novartis Vaccines and Diagnostics, Inc. was terminated on December 31, 2008 in connection
with the Novartis Pulmonary Asset Sale. |
|
(3) |
|
Partnered with Bayer Healthcare LLC since August 2007. As part of the Novartis Pulmonary Asset Sale , we retained an exclusive
license to this technology for the development and commercialization of this product originally developed by Nektar. |
|
(4) |
|
The collaboration agreement with Bayer Schering Pharma AG was assigned to Novartis on December 31, 2008 in connection with
the Novartis Pulmonary Asset Sale. |
|
(5) |
|
Partnership for the collaboration and development of Exubera inhalation powder and the next generation inhaled insulin with
Pfizer was terminated on November 9, 2007. Inhaled insulin programs were terminated in April 2008. |
|
(6) |
|
Certain proprietary pulmonary intellectual property was transferred to Novartis as part of the Novartis Pulmonary Asset Sale. |
|
(7) |
|
Other includes additional costs related Novartis Pulmonary Asset Sale in 2008, workforce reduction charges in 2008 and 2007, and
research and development costs related to our ceased super-critical fluids business in 2006. |
Research and development expense remained at a consistent level in 2008 as compared to 2007
despite a significant increase in our investment in clinical development of our proprietary drug
candidates in 2008. This was a result of the continued transition of our business to focus on our
internal proprietary drug candidates in 2008 and a decrease in other research and development
activities.
Salaries, benefits, and stock-based compensation expense decreased by approximately $14.0
million for the year ended December 31, 2008 compared to the year ended December 31, 2007, as we
continued to realize the benefits of our workforce reduction plans executed in May 2007 and
February 2008. Facilities and equipment expense decreased by approximately $8.0 million primarily
as a result of lower depreciation due to the write-off of the Pfizer-related equipment in 2007 and
certain pulmonary property and equipment classified as held for sale at September 30, 2008. These
decreases were offset by increased costs related to our ongoing clinical trials for our proprietary
drug candidates, comprised increased outside services
of $13.4 million, including costs to CROs, and increased materials and supplies expense of
$8.2 million. During the year ended December 31, 2008, research and development expense included
approximately $2.7 million in additional costs related to the Novartis Pulmonary Asset Sale,
including one-time termination benefits and other costs.
During the year ended December 31, 2008, our research and development spending in our
partnered drug development programs decreased after the termination of our Pfizer agreements for
inhaled insulin in November 2007. Spending related to our proprietary drug development programs
increased as we continued to advance clinical development for NKTR-102, NKTR-118, and NKTR-105.
Research and development expense, excluding workforce reduction charges, decreased by
approximately $1.6 million during the year ended December 31, 2007, compared to the year ended
December 31, 2006. Research and development expense related to our drug candidates based on
PEGylation technology and advanced polymer conjugate technologies increased by approximately $21.6
million as a result of the completion of the Phase 1 clinical trials for NKTR-118 and NKTR-102 and
the commencement of Phase 2 clinical trials for these drug development programs. Pulmonary
research and development program expenses decreased by approximately $20.2 million as a result of a
$20.0 million decrease related to NKTR-024 and a $12.9 million decrease related to Exubera. These
decreases are partially offset by increased spending on NGI of $11.0 million, increased spending on
TIP of $3.5 million and increased spending on BAY41-6551 of approximately $1.6 million.
Additionally, we decreased spending on non-pulmonary and non-PEGylation programs by $3.0 million in
connection with the winding down of our Bradford, UK operations in 2006 which related to our
super-critical fluid technology.
42
We anticipate that our research and development expenses will decrease in the year ended
December 31, 2009 compared to the year ended December 31, 2008, which will be comprised of
decreases in our internal salaries, benefits, and facilities costs as a result of the Novartis
Pulmonary Asset Sale, partially offset by an increase in materials and supplies and third party
costs for our CROs as we continue to advance clinical trials for NKTR-102, NKTR-118, and NKTR-105.
The estimated completion dates for our programs are not reasonably certain. See Item 1a. Risk
Factors for discussion of the risks associated with drug candidates in development and the risks
and uncertainties associated with clinical development at any stage.
General and administrative (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
General &
administrative |
|
$ |
51,497 |
|
|
$ |
57,282 |
|
|
$ |
82,358 |
|
|
$ |
(5,785 |
) |
|
$ |
(25,076 |
) |
|
|
(10 |
%) |
|
|
(30 |
%) |
General and administrative expenses are associated with administrative staffing, business
development, marketing, and legal.
The decrease in general and administrative expenses during the year ended December 31, 2008
compared to the year ended December 31, 2007 is primarily attributable to decreased professional
fees of $5.1 million and decreased salaries and benefits of $8.8 million, partially offset by
increased marketing costs of $1.7 million related to our co-promotion agreement with Bayer
Healthcare LLC for BAY41-6551, decreased corporate overhead costs allocated out of general and
administrative departments to manufacturing and research and development of $4.0 million, and other
net increases of $2.4 million.
The decrease in general and administrative expenses during the year ended December 31, 2007
compared to the year ended December 31, 2006 is primarily attributable to decreased non-cash
stock-based compensation expense of $11.9 million, decreased intangible asset amortization of $3.1
million, decreased headcount resulting in decreased salaries and benefits of $2.3 million,
decreased professional fees of $5.9 million, and a $1.8 million decrease in connection with the
winding down of our Bradford, UK operations in 2006.
Impairment of long lived assets (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Impairment of long
lived assets |
|
$ |
1,458 |
|
|
$ |
28,396 |
|
|
$ |
9,410 |
|
|
$ |
(26,938 |
) |
|
$ |
18,986 |
|
|
|
(95 |
%) |
|
|
>100 |
% |
43
During the year ended December 31, 2008, impairment of long lived assets includes an
impairment charge of $1.5 million related to a specialized dryer designed for our PEGylation
manufacturing facility. The dryer was not functioning properly and was not being used in
operations. We determined the carrying value of the manufacturing equipment exceeded the fair
value based on a discounted cash flow model.
During the year ended December 31, 2007, impairment of long lived assets includes an
impairment charge of $28.4 million for Exubera-related assets following the termination of our
collaborative agreements with Pfizer.
During the year ended December 31, 2006, impairment of long lived assets includes a write-off
of $5.5 million of certain intangible assets relating to the operations of our former Ireland
subsidiary, $1.2 million relating to the remaining laboratory and office equipment at our Bradford,
UK site, and $2.8 million relating to an asset being constructed for use in one of our partnered
pulmonary drug development programs.
Gain on sale of pulmonary assets (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Gain on sale of
pulmonary assets |
|
$ |
(69,572 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
69,572 |
|
|
$ |
|
|
|
|
n/a |
|
|
|
n/a |
|
On December 31, 2008, we sold certain of our pulmonary assets to Novartis for $115.0 million.
The gain on sale of pulmonary assets includes the purchase price received from Novartis less the
net book value of property and equipment of $37.3 million, an equity investment in Pearl
Therapeutics, Inc. of $2.7 million, transaction costs of $4.6 million, and other costs of $0.9
million.
Gain on termination of collaborative agreements, net (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Gain on termination
of collaborative
agreements, net |
|
$ |
|
|
|
$ |
(79,178 |
) |
|
$ |
|
|
|
$ |
(79,178 |
) |
|
$ |
79,178 |
|
|
|
n/a |
|
|
|
n/a |
|
On November 9, 2007, we terminated our collaborative development and license agreement with
Pfizer and all other agreements between us and Pfizer related to Exubera and NGI. Pursuant to the
termination agreement, we received a one-time payment of $135.0 million from Pfizer in full
satisfaction and release of all contract obligations. The gain on termination of collaborative
agreements, net, includes the Pfizer termination payment received of $135.0 million less our
contractual aggregate liability to Bespak and Tech Group of $32.4 million and less settlement of
outstanding receivables and payables with Pfizer of $23.5 million.
Litigation settlement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Litigation settlement |
|
$ |
|
|
|
$ |
1,583 |
|
|
$ |
17,710 |
|
|
$ |
(1,583 |
) |
|
$ |
(16,127 |
) |
|
|
n/a |
|
|
|
(91 |
)% |
During the year ended December 31, 2007, we recorded a litigation settlement charge of $1.6
million related to three employee-related litigation settlements that were entered into in 2007.
On June 30, 2006, we entered into a litigation settlement related to an intellectual property
dispute with the University of Alabama, Huntsville pursuant to which we paid $11.0 million and
agreed to pay an additional $10.0 million in equal $1.0 million installments over ten years
beginning on July 1, 2007. During the year ended December 31, 2006 we recorded a litigation
settlement charge of $17.7 million which reflects the net present value of the settlement payments
using an 8% annual discount rate.
44
Interest income (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Interest income |
|
$ |
12,495 |
|
|
$ |
22,201 |
|
|
$ |
23,646 |
|
|
$ |
(9,706 |
) |
|
$ |
(1,445 |
) |
|
|
(44 |
%) |
|
|
(6 |
%) |
The decrease in interest income for the year ended December 31, 2008, compared to the year
ended December 31, 2007, was primarily due to lower interest rates on our cash, cash equivalents,
and available-for-sale investments in 2008 compared to 2007.
The decrease in interest income during the year ended December 31, 2007 compared to the year
ended December 31, 2006 is primarily due to a decline in the average balance of cash, cash
equivalents, and investments in marketable securities due to repayment of $102.7 million in
convertible subordinated notes.
Interest expense (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Interest expense |
|
$ |
15,192 |
|
|
$ |
18,638 |
|
|
$ |
20,793 |
|
|
$ |
(3,446 |
) |
|
$ |
(2,155 |
) |
|
|
(18 |
%) |
|
|
(10 |
%) |
The decrease in interest expense for the year ended December 31, 2008, compared to the year
ended December 31, 2007, was primarily attributable to a lower average balance of convertible
subordinated notes outstanding in 2008. We repurchased $100.0 million of our 3.25% convertible
subordinated notes during the fourth quarter of 2008. We expect interest expense to decrease in
2009 as a result of this convertible subordinated note repurchase.
The decrease in interest expense during the year ended December 31, 2007 compared to the year
ended December 31, 2006 was primarily due to a lower average balance of convertible subordinated
notes outstanding during 2007. We repaid $36.0 million of our 5% convertible subordinated notes in
February 2007 and we repaid $66.6 million of our 3.5% convertible subordinated notes in October
2007.
Other income, net (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Other income
(expense), net |
|
$ |
58 |
|
|
$ |
1,133 |
|
|
$ |
2,444 |
|
|
$ |
(1,075 |
) |
|
$ |
(1,311 |
) |
|
|
(95 |
%) |
|
|
(54 |
%) |
During the year ended December 31, 2007, we recognized a $0.9 million gain from the sale of
the management buy-out of our nebulizer device business operated in our wholly-owned Ireland
subsidiary, which was completed on November 30, 2007 in consideration of a payment to us of $2.2
million and a net gain of $0.9 million.
During the year ended December 31, 2006, we recognized a $2.2 million gain from the sale of an
equity investment in Confluent Technologies. We do not expect to realize income from such
transactions in the future.
45
Gain on debt extinguishment (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Gain on debt extinguishment |
|
$ |
50,149 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
50,149 |
|
|
$ |
|
|
|
|
n/a |
|
|
|
n/a |
|
During the three months ended December 31, 2008, we repurchased approximately $100.0 million
in par value of our 3.25% convertible subordinated notes for an aggregate purchase price of $47.8
million. The recognized gain on debt extinguishment is net of transaction costs of $1.0 million
and accelerated amortization of our deferred financing costs of $1.1 million.
Liquidity and Capital Resources
We have financed our operations primarily through revenue from product sales and royalties and
research and development contracts, public and private placements of debt and equity. We do not
utilize off-balance sheet financing arrangements as a source of liquidity or financing.
Additionally, at December 31, 2008, we had letter of credit arrangements with certain financial
institutions and vendors, including our landlord, totaling $2.9 million. These letters of credit
expire during 2009 and are secured by investments in similar amounts.
As of December 31, 2008, we had cash, cash equivalents and investments in marketable
securities of $379.0 million and indebtedness of $242.6 million, including $215.0 million of
convertible subordinated notes, $21.6 million in capital lease obligations and $6.0 million in
other liabilities.
Due to the recent adverse developments in the credit markets, we may experience reduced
liquidity with respect to some of our short-term investments. These investments are generally held
to maturity, which is less than one year. However, if the need arose to liquidate such securities
before maturity, we may experience losses on liquidation. As of December 31, 2008, we held $233.6
million of available-for-sale investments, excluding money market funds, with an average time to
maturity of 72 days. To date we have not experienced any liquidity issues with respect to these
securities, but should such issues arise, we may be required to hold some, or all, of these
securities until maturity. We believe that, even allowing for potential liquidity issues with
respect to these securities, our remaining cash and cash equivalents and short-term investments
will be sufficient to meet our anticipated cash needs for at least the next twelve months. We have
the ability and intent to hold our debt securities to maturity when they will be redeemed at full
par value. Accordingly, we consider unrealized losses to be temporary and have not recorded a
provision for impairment.
Cash flows used in operating activities
During the year ended December 31, 2008, net cash used for our operating activities was $145.8
million. The decrease in net cash provided by our operating activities for the year ended December
31, 2008 as compared to the year ended December 31, 2007, resulted from the $135.0 million cash
payment received from Pfizer in 2007 under the Exubera termination agreement and up-front payments
of $50.0 million and $24.6 million received in 2007 from Bayer Healthcare LLC and Pfizer,
respectively. In addition, the net cash used for our operating activities for the year ended
December 31, 2008 included a number of significant items including a $10.0 million clinical
development milestone received from Bayer Healthcare LLC under our collaboration agreement for
BAY41-6551 (NKTR-061, Amikacin Inhale), payments by us to Bespak Europe Ltd. and Tech Group, Inc.
of $39.9 million for amounts due under termination agreements with these Exubera inhaler device
contract manufacturers, all of which was recorded as an expense in 2007, $6.8 million paid to
maintain Exubera manufacturing capacity through April 2008, and $5.4 million for severance,
employee benefits, and outplacement services in connection with our workforce reduction plans. We
expect our cash flows used in operations to decrease in 2009.
During the year ended December 31, 2007, net cash provided by operating activities was $146.3
million. During the year ended December 31, 2007, net cash provided by operating activities
increased by $239.0 million compared to the year ended December 31, 2006, in which we used $92.7
million in operating activities. The increase in cash provided by operations in the year ended
December 31, 2007 included a number of significant items including a contract termination payment
received from Pfizer of $135.0 million and up-front payments of $50.0 million and $24.6 million
received from Bayer Healthcare LLC and Pfizer, respectively.
46
Cash flows from investing activities
On December 31, 2008, we completed the sale of certain pulmonary assets to Novartis for a
purchase price of $115.0 million. We paid $0.2 million in transaction costs related to the sale
during the year ended December 31, 2008 and expect to pay approximately $4.4 million in transaction
costs in the three months ending March 31, 2009, all of which we expensed in the three months ended
December 31, 2008.
We purchased $18.9 million, $32.8 million, and $22.5 million of property and equipment in the
year ended December 31, 2008, 2007, and 2006, respectively. We expect our capital additions to
remain at a consistent level during the year ended December 31, 2009, as we complete our research
and development facility in Hyderabad, India.
In July 2008, we invested $4.2 million in Pearl Therapeutics Inc. (Pearl). In 2007, we
granted Pearl a limited field intellectual property license to certain of our proprietary pulmonary
delivery technology. Upon the closing of the Novartis asset sale transaction on December 31, 2008,
we transferred our ownership interest in Pearl to Novartis and assigned the intellectual property
license to Novartis.
Cash flows used in financing activities
During the year ended December 31, 2008, we repurchased approximately $100.0 million in par
value of our 3.25% convertible subordinated notes for an aggregate purchase price of $47.8 million.
The $215.0 million of 3.25% convertible subordinated notes outstanding at December 31, 2008, are
due in September 2012.
During the year ended December 31, 2007, we repaid $102.7 million of convertible subordinated
notes.
Contractual Obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period |
|
|
|
|
|
|
|
<=1 yr |
|
|
2-3 yrs |
|
|
4-5 yrs |
|
|
|
|
|
|
Total |
|
|
2009 |
|
|
2010-2011 |
|
|
2012-2013 |
|
|
2014+ |
|
Obligations (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible subordinated notes, including interest |
|
$ |
241,153 |
|
|
$ |
6,986 |
|
|
$ |
13,972 |
|
|
$ |
220,195 |
|
|
$ |
|
|
Capital leases, including interest |
|
|
38,822 |
|
|
|
4,717 |
|
|
|
9,659 |
|
|
|
10,022 |
|
|
|
14,424 |
|
Purchase commitments (2) |
|
|
17,042 |
|
|
|
17,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Litigation settlement, including interest |
|
|
8,000 |
|
|
|
1,000 |
|
|
|
2,000 |
|
|
|
2,000 |
|
|
|
3,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
305,017 |
|
|
$ |
29,745 |
|
|
$ |
25,631 |
|
|
$ |
232,217 |
|
|
$ |
17,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The above table does not include certain commitments and contingencies which are discussed in
Note 8 of Item 8. Financial Statements and Supplementary Data. |
|
(2) |
|
Substantially all of this amount was subject to open purchase orders as of December 31, 2008
that were issued under existing contracts. This amount does not represent minimum contract
termination liability. |
Given our current cash requirements, we forecast that we will have sufficient cash to meet our
net operating expense requirements and contractual obligations at least through December 31, 2010.
We plan to continue to invest in our growth and our future cash requirements will depend upon the
timing and results of these investments. Our capital needs will depend on many factors, including
continued progress in our research and development programs, progress with preclinical and clinical
trials of our proprietary and partnered drug candidates, our ability to successfully enter into
additional collaboration agreements for one or more of our proprietary drug candidates or
intellectual property that we control, the time and costs involved in obtaining regulatory
approvals, the costs of developing and scaling our clinical and commercial manufacturing
operations, the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent
claims, the need to acquire licenses to new technologies and the status of competitive products.
Included in our purchase commitments above is approximately $2.7 million of capital purchase
commitments.
47
To date we have incurred substantial debt as a result of our issuances of subordinated notes
that are convertible into our common stock. Our substantial debt, the market price of our
securities, and the general economic climate, among other factors, could have material consequences
for our financial condition and could affect our sources of short-term and long-term funding. Our
ability to meet our ongoing operating expenses and repay our outstanding indebtedness is dependent
upon our and our partners ability to successfully complete clinical development of, obtain
regulatory approvals for and successfully commercialize new drugs. Even if we or our partners are
successful, we may require additional capital to continue to fund our operations and repay our debt
obligations as they become due. There can be no assurance that additional funds, if and when
required, will be available to us on favorable terms, if at all.
Off Balance Sheet Arrangements
We do not utilize off-balance sheet financing arrangements as a source of liquidity or
financing.
Critical Accounting Policies
The preparation of financial statements in conformity with U.S. Generally Accepted Accounting
Principles (GAAP) requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period.
We base our estimates on historical experience and on various other assumptions that we
believe to be reasonable under the circumstances, the results of which form our basis for making
judgments about the carrying value of assets and liabilities that are not readily apparent from
other sources, and evaluate our estimates on an ongoing basis. Actual results may differ from those
estimates under different assumptions or conditions. We have determined that for the periods
reported in this report, the following accounting policies and estimates are critical in
understanding our financial condition and results of our operations.
Revenue Recognition
Collaboration and other research revenue includes amortization of up-front fees. Up-front fees
should be recognized ratably over the expected benefit period under the arrangement. Given the
uncertainties of research and development collaborations, significant judgment is required to
determine the duration of the arrangement. We have $57.2 million of deferred up-front fees related
to five research and collaboration agreements that are being amortized over an average of 12 years.
We considered shorter and longer amortization periods. The shortest reasonable period is the end of
the development period (estimated to be 4 to 6 years). Given the statistical probability of drug
development success in the bio-pharmaceutical industry, drug development programs have only a
5%-10% probability of reaching commercial success. The longest period is either the contractual
life of the agreement, which is generally 10-12 years from the first commercial sale, or the end of
the patent life, which is frequently 15-17 years. If we had determined a longer or shorter
amortization period was appropriate, our annual up-front fee amortization could be as low as $4.0
million or as high as $14.0 million.
Milestone payments that we receive under our collaboration agreements are deferred and
recorded as revenue ratably over the period of time between the achievement of the milestone and
the estimated date of completion of the next development milestone. Management makes its best
estimate of the period of time until the next milestone is reached. This estimate affects the
recognition of revenue for completion of the previous milestone. The original estimate is
periodically evaluated to determine if circumstances have caused the estimate to change and if so,
amortization of revenue is adjusted prospectively.
Stock-Based Compensation
We use the Black-Scholes option valuation model adjusted for the estimated historical
forfeiture rate for the respective grant to determine the estimated fair value of our stock-based
compensation arrangements on the date of grant (grant date fair value) and expense this value
ratably over the service period of the option or performance period of the Restricted Stock Unit
award (RSU). The Black-Scholes option pricing model requires the input of highly subjective
assumptions. Because our employee stock options have characteristics significantly different from
those of traded options, and because changes in the subjective input assumptions can materially
affect the fair value estimate, in managements opinion, the existing models may not provide a
reliable single measure of the fair value of our employee stock options or common stock purchased
under our employee stock purchase plan. In addition, management continually assesses these assumptions
and methodologies used to calculate the estimated fair value of stock-based compensation.
Circumstances may change and additional data may become available over time, which could result in
changes to the assumptions and methodologies, and which could materially impact our fair value
determination.
48
Further, we have issued performance-based RSU awards totaling approximately 1,010,000 shares
of our common stock to certain employees. These awards vest based upon achieving three
pre-determined performance milestones. We are expensing the grant date fair value of the awards
ratably over the expected performance period for the RSU awards in which the performance milestones
are probable of achievement under a Statement of Financial Accounting Standards No. 5, Accounting
for Contingencies, definition. The total grant date fair value of the RSU awards was $19.8 million,
including $4.0 million for the first milestone, $7.9 million for the second milestone, and $7.9
million for the third milestone.
The first performance milestone was achieved and approximately 174,035 shares were fully
vested and released during the year ended December 31, 2007. The second performance milestone
related to the achievement of $30.0 million of Exubera royalty revenue from Pfizer in one calendar
quarter. During the year ended December 31, 2007, we determined that it is not probable that future
Exubera product sales will be sufficient to meet the second performance milestone and we reversed
$2.8 million of previously recognized expense. The third performance milestone relates to the first
filing (whether by us or a third party licensee or partner of ours) and acceptance of a New Drug
Application (NDA) or Biologics License Application (BLA) by the FDA or an equivalent filing and
acceptance with the European Medicines Agency for a proprietary drug candidate. Based on our
current product pipeline development efforts, we currently estimate that the third performance
milestone is currently probable of achievement by the end of the third quarter of 2011.
Evaluating and estimating the probability of achieving the remaining performance milestone and
the appropriate timing related to the achievement is highly subjective and requires periodic
reassessment of rapidly changing facts and circumstances. Actual achievement of these performance
milestones or changes in facts and circumstances may cause significant fluctuations in expense
recognition between reporting periods and would result in changes in the timing and amount of
expense recognition related to these RSU awards.
Clinical Trial Accruals
We record accruals for the estimated costs of our clinical trials. Most of our clinical trials
are performed by third-party CROs, which are a significant component of our Research and
development expense. We accrue costs associated with the start-up and reporting phases of the
clinical trials ratably over the estimated duration of the start-up and reporting phases. If the
actual timing of these phases varies from the estimate, we will adjust the accrual prospectively.
We accrue costs associated with treatment phase of clinical trials based on the total estimated
cost of the clinical trials and are expensed ratably based on patient enrollment in the trials.
Income Taxes
We account for income taxes under the liability method in accordance with FASB Statement No.
109, Accounting for Income Taxes, and FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income TaxesAn Interpretation of FASB Statement No. 109. Under this method,
deferred tax assets and liabilities are determined based on differences between financial reporting
and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws
that are expected to be in effect when the differences are expected to reverse. Realization of
deferred tax assets is dependent upon future earnings, the timing and amount of which are
uncertain. FIN 48 contains a two-step approach to recognizing and measuring uncertain tax
positions. The first step is to evaluate the tax position by determining if the weight of available
evidence indicates that it is more likely than not that the position will be sustained upon tax
authority examination, including resolution of related appeals or litigation processes, if any. The
second step is to measure the tax benefit as the largest amount that is more than 50% likely of
being realized upon ultimate settlement.
Adoption of FIN 48, which occurred on January 1, 2007, had no impact on our consolidated
financial position, results of operations, cash flows or our effective tax rate. However, revisions
to the estimated net realizable value of the deferred tax asset in the future could cause our
provision for income taxes to vary significantly from period to period.
At December 31, 2008, we had significant federal and state net operating loss and research
credit carry forwards which were offset by a full valuation allowance, due to our inability to
estimate long-term future taxable income with a more likely than not certainty. Upon adoption of
FIN 48, we did not recognize an increase or a decrease in the liability for net unrecognized tax
benefits, which would be accounted for through retained earnings. We historically accrued for
uncertain tax
positions in deferred tax assets as we have been in a net operating loss position since
inception and any adjustments to our tax positions would result in an adjustment of our net
operating loss or tax credit carry forwards rather than resulting in a cash outlay. If we are
eventually able to recognize these uncertain positions, our effective tax rate would be reduced. We
currently have a full valuation allowance against our net deferred tax asset which would impact the
timing of the effective tax rate benefit should any of these uncertain tax positions be favorably
settled in the future.
49
On a periodic basis, we will continue to evaluate the realizability of our deferred tax assets
and liabilities and adjust such amounts in light of changing facts and circumstances, including but
not limited to the level of past and future taxable income, the utilization of the carry forwards,
tax legislation, rulings by relevant tax authorities, tax planning strategies and if applicable,
the progress of ongoing tax audits. The ultimate realization of deferred tax assets is dependent
upon the generation of future taxable income during the period in which those temporary differences
become deductible or the net operating loss and research credit carry forwards can be utilized.
Recent Accounting Pronouncements
FASB Statement of Position No. 157-2
In February 2008, the FASB issued FASB Staff Position 157-2, Effective Date of FASB Statement
No. 157 (FSP 157-2), which delays the effective date of SFAS No. 157 to fiscal years beginning
after November 15, 2008, for all nonfinancial assets and nonfinancial liabilities, except for items
that are recognized or disclosed at fair value in the financial statements on a recurring basis (at
least annually). In accordance with FSP 157-2, the fair value measurements for non-financial
assets and liabilities is required to be adopted effective for fiscal years beginning after
November 15, 2008 We believe the adoption of the delayed items of SFAS No. 157 will not have a
material impact on our financial statements.
EITF 07-1
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which defines collaborative arrangements and establishes reporting and disclosure
requirements for transactions between participants in a collaborative arrangement and between
participants in the arrangements and third parties. This issue is effective retrospectively to all
prior periods presented for all collaborative arrangements existing as of the effective date for
fiscal years beginning after December 15, 2008. We believe the adoption of EITF 07-1 will not
have a material impact on our financial statements.
FSP APB 14-1
In May 2008, the FASB issued FSP Accounting Principles Board (APB) 14-1 Accounting for
Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement) (FSP APB 14-1). FSP APB 14-1 addresses instruments commonly referred to as Instrument
C from EITF 90-19, which requires the issuer to settle the principal amount in cash and the
conversion spread in cash or net shares at the issuers option. FSP APB 14-1 requires the issuer
of these instruments account for the liability (debt) and equity (conversion option) components of
the instrument in a manner that reflects the issuers nonconvertible debt borrowing rate. FSP APB
14-1 is effective for fiscal years beginning after December 15, 2008 and interim periods within
those fiscal years on a retroactive basis. Early application is not permitted. The noteholders may
only convert outstanding convertible subordinated notes to shares of our common stock, therefore we
do not expect FSP APB 14-1 to have a material impact on our financial position or results of
operations.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate and Market Risk
The primary objective of our investment activities is to preserve principal while at the same
time maximizing yields without significantly increasing risk. To achieve this objective, we invest
in liquid, high quality debt securities. Our investments in debt securities are subject to interest
rate risk. To minimize the exposure due to an adverse shift in interest rates, we invest in
short-term securities and maintain a weighted average maturity of one year or less.
A hypothetical 50 basis point increase in interest rates would result in an approximate $0.4
million decrease, less than 1%, in the fair value of our available-for-sale securities at December
31, 2008. This potential change is based on sensitivity
analyses performed on our investment securities at December 31, 2008. Actual results may
differ materially. The same hypothetical 50 basis point increase in interest rates would have
resulted in an approximate $0.7 million decrease, less than 1%, in the fair value of our
available-for-sale securities at December 31, 2007.
50
Due to the adverse developments in the credit markets in 2008, we may experience reduced
liquidity with respect to some of our short-term investments. These investments are generally held
to maturity, which is less than one year. However, if the need arose to liquidate such securities
before maturity, we may experience losses on liquidation. As of December 31, 2008, we held $233.6
million of available-for-sale investments, excluding money market funds, with an average time to
maturity of 72 days. To date we have not experienced any liquidity issues with respect to these
securities, but should such issues arise, we may be required to hold some, or all, of these
securities until maturity. We believe that, even allowing for potential liquidity issues with
respect to these securities, our remaining cash and cash equivalents and short-term investments
will be sufficient to meet our anticipated cash needs for at least the next twelve months. We have
the ability and intent to hold our debt securities to maturity when they will be redeemed at full
par value. Accordingly, we consider unrealized losses to be temporary and have not recorded a
provision for impairment.
Foreign Currency Risk
The majority of our revenue, expense, and capital purchasing activities are transacted in U.S.
dollars. However, since a portion of our operations consists of research and development activities
outside the United States, we have entered into transactions in other currencies, primarily the
Indian Rupee, and we therefore are subject to foreign exchange risk.
Our international operations are subject to risks typical of international operations,
including, but not limited to, differing economic conditions, changes in political climate,
differing tax structures, other regulations and restrictions, and foreign exchange rate volatility.
We do not utilize derivative financial instruments to manage our exchange rate risks.
51
Item 8. Financial Statements and Supplementary Data
NEKTAR THERAPEUTICS
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
52
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders, Nektar Therapeutics
We have audited the accompanying consolidated balance sheets of Nektar Therapeutics as of
December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders
equity and cash flows for each of the three years in the period ended December 31, 2008. Our audits
also included the financial statement schedule listed in the Index at Item 15(a)(2). These
financial statements and schedule are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial statements and schedule based on our
audits.
We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the consolidated financial position of Nektar Therapeutics at December 31, 2008 and 2007,
and the consolidated results of its operations and its cash flows for each of the three years in
the period ended December 31, 2008, in conformity with U.S. generally accepted accounting
principles. Also, in our opinion, the related financial statement schedule, when considered in
relation to the basic financial statements taken as a whole, presents fairly in all material
respects the information set forth therein.
As discussed in Note 1 to the consolidated financial statements, Nektar Therapeutics changed
its method of accounting for uncertain tax positions as of January 1, 2007.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), Nektars internal control over financial reporting as of December
31, 2008, based on criteria established in Internal Control-Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission and
our report dated March 4, 2009
expressed an unqualified opinion thereon.
/s/ ERNST & YOUNG LLP
San Jose, California
March 4, 2009
53
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders, Nektar Therapeutics
We have audited Nektar Therapeutics internal control over financial reporting as of December
31, 2008, based on criteria established in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Nektar
Therapeutics management is responsible for maintaining effective internal control over financial
reporting, and for its assessment of the effectiveness of internal control over financial reporting
included in the accompanying Management Report on Internal Control over Financial Reporting. Our
responsibility is to express an opinion on the companys internal control over financial reporting
based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk,
and performing such other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting
principles. A companys internal control over financial reporting includes those policies and
procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately
and fairly reflect the transactions and dispositions of the assets of the company; (2) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with authorizations of management and
directors of the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use or disposition of the companys assets that could have a
material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Nektar Therapeutics maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2008, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of Nektar Therapeutics as of
December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders
equity and cash flows for each of the three years in the period ended December 31, 2008 of Nektar
Therapeutics and our report dated March 4, 2009 expressed an unqualified opinion thereon.
/s/ ERNST & YOUNG LLP
San Jose, California
March 4, 2009
54
NEKTAR THERAPEUTICS
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share information)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
155,584 |
|
|
$ |
76,293 |
|
Short-term investments |
|
|
223,410 |
|
|
|
406,060 |
|
Accounts receivable, net of allowance of
$92 and $33 at December 31, 2008 and 2007,
respectively |
|
|
11,161 |
|
|
|
21,637 |
|
Inventory |
|
|
9,319 |
|
|
|
12,187 |
|
Other current assets |
|
|
6,746 |
|
|
|
7,106 |
|
|
|
|
|
|
|
|
Total current assets |
|
$ |
406,220 |
|
|
$ |
523,283 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
73,578 |
|
|
|
114,420 |
|
Goodwill |
|
|
76,501 |
|
|
|
78,431 |
|
Other assets |
|
|
4,237 |
|
|
|
8,969 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
560,536 |
|
|
$ |
725,103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
13,832 |
|
|
$ |
3,589 |
|
Accrued compensation |
|
|
11,570 |
|
|
|
14,680 |
|
Accrued clinical trial expenses |
|
|
17,622 |
|
|
|
2,895 |
|
Accrued expenses to contract manufacturers |
|
|
|
|
|
|
40,444 |
|
Accrued expenses |
|
|
9,923 |
|
|
|
9,551 |
|
Deferred revenue, current portion |
|
|
10,010 |
|
|
|
19,620 |
|
Other current liabilities |
|
|
5,417 |
|
|
|
7,313 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
$ |
68,374 |
|
|
$ |
98,092 |
|
Convertible subordinated notes |
|
|
214,955 |
|
|
|
315,000 |
|
Capital lease obligations |
|
|
20,347 |
|
|
|
21,632 |
|
Deferred revenue |
|
|
55,567 |
|
|
|
61,349 |
|
Deferred gain |
|
|
5,901 |
|
|
|
8,680 |
|
Other long-term liabilities |
|
|
5,238 |
|
|
|
5,911 |
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
370,382 |
|
|
$ |
510,664 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, 10,000 shares authorized
|
|
|
|
|
|
|
|
|
Series A, $0.0001 par value: 3,100 shares
designated; no shares issued or
outstanding at December 31, 2008 and 2007 |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 300,000
authorized; 92,503 shares and 92,301
shares issued and outstanding at December
31, 2008 and 2007, respectively |
|
|
9 |
|
|
|
9 |
|
Capital in excess of par value |
|
|
1,312,796 |
|
|
|
1,302,541 |
|
Accumulated other comprehensive income |
|
|
1,439 |
|
|
|
1,643 |
|
Accumulated deficit |
|
|
(1,124,090 |
) |
|
|
(1,089,754 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
190,154 |
|
|
|
214,439 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
560,536 |
|
|
$ |
725,103 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
55
NEKTAR THERAPEUTICS
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and royalties |
|
$ |
41,255 |
|
|
$ |
180,755 |
|
|
$ |
153,556 |
|
Collaboration and other |
|
|
48,930 |
|
|
|
92,272 |
|
|
|
64,162 |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
28,216 |
|
|
|
137,696 |
|
|
|
113,921 |
|
Other cost of revenue |
|
|
6,821 |
|
|
|
9,821 |
|
|
|
4,168 |
|
Research and development |
|
|
154,417 |
|
|
|
153,575 |
|
|
|
149,381 |
|
General and administrative |
|
|
51,497 |
|
|
|
57,282 |
|
|
|
82,358 |
|
Impairment of long lived assets |
|
|
1,458 |
|
|
|
28,396 |
|
|
|
9,410 |
|
Gain on sale of pulmonary assets |
|
|
(69,572 |
) |
|
|
|
|
|
|
|
|
Gain on termination of collaborative agreements, net |
|
|
|
|
|
|
(79,178 |
) |
|
|
|
|
Litigation settlement |
|
|
|
|
|
|
1,583 |
|
|
|
17,710 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
$ |
172,837 |
|
|
$ |
309,175 |
|
|
$ |
376,948 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(82,652 |
) |
|
|
(36,148 |
) |
|
|
(159,230 |
) |
|
|
|
|
|
|
|
|
|
|
Non-Operating income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
12,495 |
|
|
|
22,201 |
|
|
|
23,646 |
|
Interest expense |
|
|
(15,192 |
) |
|
|
(18,638 |
) |
|
|
(20,793 |
) |
Other income (expense), net |
|
|
58 |
|
|
|
1,133 |
|
|
|
2,444 |
|
Gain on extinguishment of debt |
|
|
50,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-operating income |
|
|
47,510 |
|
|
|
4,696 |
|
|
|
5,297 |
|
|
|
|
|
|
|
|
|
|
|
Loss before provision (benefit) for income taxes |
|
$ |
(35,142 |
) |
|
$ |
(31,452 |
) |
|
$ |
(153,933 |
) |
Provision (benefit) for income taxes |
|
|
(806 |
) |
|
|
1,309 |
|
|
|
828 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(34,336 |
) |
|
$ |
(32,761 |
) |
|
$ |
(154,761 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.37 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.72 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share |
|
|
92,407 |
|
|
|
91,876 |
|
|
|
89,789 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
56
NEKTAR THERAPEUTICS
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Preferred Shares |
|
|
Common Shares |
|
|
Capital In |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
Amount |
|
|
|
|
|
Excess of |
|
|
Deferred |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders |
|
|
|
Shares |
|
|
Paid In |
|
|
Shares |
|
|
Par Value |
|
|
Par Value |
|
|
Compensation |
|
|
Income/(Loss) |
|
|
Deficit |
|
|
Equity |
|
Balance at December 31, 2005 |
|
|
20 |
|
|
|
|
|
|
|
87,707 |
|
|
$ |
9 |
|
|
$ |
1,233,690 |
|
|
$ |
(2,949 |
) |
|
$ |
(1,707 |
) |
|
$ |
(902,232 |
) |
|
$ |
326,811 |
|
Stock option exercises |
|
|
|
|
|
|
|
|
|
|
2,326 |
|
|
|
|
|
|
|
20,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,642 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,143 |
|
SFAS No. 123R transition adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,949 |
) |
|
|
2,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Preferred Stock |
|
|
(20 |
) |
|
|
|
|
|
|
1,023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercises |
|
|
|
|
|
|
|
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued for employee plans(1) |
|
|
|
|
|
|
|
|
|
|
212 |
|
|
|
|
|
|
|
3,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,425 |
|
Stock-based compensation to consultants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,769 |
|
|
|
|
|
|
|
1,769 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(154,761 |
) |
|
|
(154,761 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(152,992 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
91,280 |
|
|
$ |
9 |
|
|
$ |
1,283,982 |
|
|
$ |
|
|
|
$ |
62 |
|
|
$ |
(1,056,993 |
) |
|
$ |
227,060 |
|
Stock option exercises and RSU release |
|
|
|
|
|
|
|
|
|
|
761 |
|
|
|
|
|
|
|
2,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,915 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,193 |
|
Shares issued for employee plans(1) |
|
|
|
|
|
|
|
|
|
|
260 |
|
|
|
|
|
|
|
2,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,451 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,581 |
|
|
|
|
|
|
|
1,581 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(32,761 |
) |
|
|
(32,761 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
92,301 |
|
|
$ |
9 |
|
|
$ |
1,302,541 |
|
|
$ |
|
|
|
$ |
1,643 |
|
|
$ |
(1,089,754 |
) |
|
$ |
214,439 |
|
Stock option exercises and RSU release |
|
|
|
|
|
|
|
|
|
|
146 |
|
|
|
|
|
|
|
122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
122 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,871 |
|
Shares issued for employee plans(1) |
|
|
|
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
262 |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(204 |
) |
|
|
|
|
|
|
(204 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,336 |
) |
|
|
(34,336 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,540 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
92,503 |
|
|
$ |
9 |
|
|
$ |
1,312,796 |
|
|
$ |
|
|
|
$ |
1,439 |
|
|
$ |
(1,124,090 |
) |
|
$ |
190,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Employee plans include Employee Stock Purchase Plan (ESPP) and 401K Plan |
The accompanying notes are an integral part of these consolidated financial statements.
57
NEKTAR THERAPEUTICS
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Cash flows provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(34,336 |
) |
|
$ |
(32,761 |
) |
|
$ |
(154,761 |
) |
Adjustments to reconcile net loss to net cash provided by (used in)
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of pulmonary assets |
|
|
(69,572 |
) |
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
|
|
(50,149 |
) |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
22,489 |
|
|
|
29,028 |
|
|
|
33,509 |
|
Stock-based compensation |
|
|
9,871 |
|
|
|
14,779 |
|
|
|
30,982 |
|
Impairment of long lived assets |
|
|
1,458 |
|
|
|
28,396 |
|
|
|
9,410 |
|
Other non-cash transactions |
|
|
1,251 |
|
|
|
109 |
|
|
|
(3,003 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in trade accounts receivable |
|
|
10,476 |
|
|
|
24,318 |
|
|
|
(34,654 |
) |
Decrease (increase) in inventories |
|
|
2,868 |
|
|
|
1,503 |
|
|
|
3,971 |
|
Decrease (increase) in other assets |
|
|
1,166 |
|
|
|
7,443 |
|
|
|
1,095 |
|
Increase (decrease) in accounts payable |
|
|
6,181 |
|
|
|
(3,147 |
) |
|
|
(8,926 |
) |
Increase (decrease) in accrued compensation |
|
|
(3,382 |
) |
|
|
986 |
|
|
|
3,581 |
|
Increase (decrease) in accrued clinical trial expenses |
|
|
14,727 |
|
|
|
907 |
|
|
|
1,322 |
|
Increase (decrease) in accrued expenses to contract manufacturers |
|
|
(40,444 |
) |
|
|
40,444 |
|
|
|
|
|
Increase (decrease) in accrued expenses |
|
|
(1,332 |
) |
|
|
(5,200 |
) |
|
|
4,181 |
|
Increase (decrease) in deferred revenue |
|
|
(15,392 |
) |
|
|
40,863 |
|
|
|
16,245 |
|
Increase (decrease) in other liabilities |
|
|
(1,662 |
) |
|
|
(1,366 |
) |
|
|
4,333 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
$ |
(145,782 |
) |
|
$ |
146,302 |
|
|
$ |
(92,715 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of pulmonary assets, net of transaction costs |
|
|
114,831 |
|
|
|
|
|
|
|
|
|
Investment in Pearl Therapeutics |
|
|
(4,236 |
) |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(18,855 |
) |
|
|
(32,796 |
) |
|
|
(22,524 |
) |
Maturities of investments |
|
|
588,168 |
|
|
|
591,202 |
|
|
|
405,622 |
|
Sales of investments |
|
|
70,060 |
|
|
|
2,057 |
|
|
|
2,252 |
|
Purchases of investments |
|
|
(475,316 |
) |
|
|
(593,118 |
) |
|
|
(502,230 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
$ |
274,652 |
|
|
$ |
(32,655 |
) |
|
$ |
(116,880 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net of issuance costs |
|
|
384 |
|
|
|
3,780 |
|
|
|
22,259 |
|
Payments of loan and capital lease obligations |
|
|
(2,368 |
) |
|
|
(2,895 |
) |
|
|
(10,488 |
) |
Repayments of convertible subordinated notes |
|
|
(47,757 |
) |
|
|
(102,653 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
$ |
(49,741 |
) |
|
$ |
(101,768 |
) |
|
$ |
11,771 |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
162 |
|
|
|
654 |
|
|
|
311 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
79,291 |
|
|
$ |
12,533 |
|
|
$ |
(197,513 |
) |
Cash and cash equivalents at beginning of year |
|
|
76,293 |
|
|
|
63,760 |
|
|
|
261,273 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
155,584 |
|
|
$ |
76,293 |
|
|
$ |
63,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flows information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
14,706 |
|
|
$ |
17,389 |
|
|
$ |
17,751 |
|
Cash paid for income taxes |
|
$ |
812 |
|
|
$ |
801 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Property acquired through capital leases |
|
$ |
|
|
|
$ |
4,445 |
|
|
$ |
|
|
The accompanying notes are an integral part of these consolidated financial statements.
58
NEKTAR THERAPEUTICS
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2008
Note 1Organization and Summary of Significant Accounting Policies
Organization and Basis of Presentation
We are a clinical-stage biopharmaceutical company headquartered in San Carlos, California and
incorporated in Delaware. We are developing a pipeline of drug candidates that utilize our
PEGylation and advanced polymer conjugate technology platforms designed to improve the therapeutic
benefits of drugs.
Principles of Consolidation and Use of Estimates
Our consolidated financial statements include the financial position and results of operations
and cash flows of our wholly-owned subsidiaries: Nektar Therapeutics AL, Corporation, Nektar
Therapeutics (India) Private Limited, Nektar Therapeutics UK, Ltd., and Aerogen Inc. All
intercompany accounts and transactions have been eliminated in consolidation.
Our consolidated financial statements are denominated in U.S. dollars. Accordingly, changes in
exchange rates between the applicable foreign currency and the U.S. dollar will affect the
translation of each foreign subsidiarys financial results into U.S. dollars for purposes of
reporting our consolidated financial results. Translation gains and losses are included in
accumulated other comprehensive loss in the stockholders equity section of the balance sheet. To
date, such cumulative translation adjustments have not been material to our consolidated financial
position. Transaction gains and losses arising from activities in other than applicable functional
currency are calculated using the average exchange rate for the applicable period and reported in
net income as a non-operating item in each period. Aggregate gross foreign currency transaction
gains (losses) recorded in net income for the years ended December 31, 2008, 2007, and 2006 were
not material.
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles (GAAP) requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates. On an ongoing basis, we evaluate our
estimates, including those related to inventories and related impairment of investments and long
lived assets, restructuring and contingencies, stock based compensation, and litigation. We base
our estimates on historical experience and on other assumptions that management believes are
reasonable under the circumstances. These estimates form the basis for making judgments about the
carrying values of assets and liabilities when these values are not readily apparent from other
sources.
Reclassifications
Certain items previously reported in specific financial statement captions have been
reclassified to conform to the current period presentation. Such reclassifications have not
impacted previously reported revenues, operating loss or net loss.
Cash, Cash Equivalents, and Investments and Fair Value of Financial Instruments
We consider all investments in marketable securities with an original maturity of three months
or less to be cash equivalents. Investments are designated as available-for-sale and are carried at
fair value, with unrealized gains and losses reported in stockholders equity as accumulated other
comprehensive income (loss). The disclosed fair value related to our investments is based primarily
on the reported fair values in our period-end brokerage statements. We independently validate these
fair values using available market quotes and other information. Investments with maturities
greater than one year from the balance sheet date, if any, are classified as long-term.
Interest and dividends on securities classified as available-for-sale, as well as amortization
of premiums and accretion of discounts to maturity, are included in interest income. Realized gains
and losses and declines in value of available-for-sale securities judged to be
other-than-temporary, if any, are included in other income (expense). The cost of securities sold
is based on the specific identification method.
59
The carrying value of cash, cash equivalents, and investments approximates fair value and is
based on quoted market prices. On January 1, 2008, we adopted the provisions of Statement of
Financial Accounting Standards No. 157, Fair Value Measurements (SFAS No. 157), for financial
assets and financial liabilities. SFAS No. 157 defines fair value, establishes a framework for
measuring fair value in GAAP, and expands disclosures about fair value measurements. SFAS No. 157
does not require any new fair value measurements, but provides guidance on how to measure fair
value by providing a fair value hierarchy used to classify the source of the information. The
standard describes a fair value hierarchy based on three levels of inputs, of which the first two
are considered observable and the last unobservable, that may be used to measure fair value which
are the following:
Level 1Quoted prices in active markets for identical assets or liabilities that the entity
has the ability to access.
Level 2Inputs other than Level 1 that are observable, either directly or indirectly, such as
quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or
other inputs that are observable or can be corroborated by observable market data for substantially
the full term of the assets or liabilities.
Level 3Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
A financial instruments level within the fair value hierarchy is based on the lowest level of
any input that is significant to the fair value measurement.
In accordance with FASB Statement of Position No. 157-2, we have deferred adoption of SFAS No.
157 for non-financial assets and non-financial liabilities, including goodwill and property and
equipment, until January 1, 2009.
Accounts Receivable and Significant Customer Concentrations
Our customers are primarily pharmaceutical and biotechnology companies that are located in the
U.S. and Europe. Our accounts receivable balance contains billed and unbilled trade receivables
from product sales and royalties and collaborative research agreements. We provide for an allowance
for doubtful accounts by reserving for specifically identified doubtful accounts. We generally do
not require collateral from our customers. We perform a regular review of our customers payment
histories and associated credit risk. We have not experienced significant credit losses from our
accounts receivable. At December 31, 2008, three different customers represented 29%, 19%, and 15%,
respectively, of our accounts receivable. At December 31, 2007, three different customers
represented 28%, 24%, and 22%, respectively, of our accounts receivable.
Inventories and Significant Supplier Concentrations
Inventories are computed on a first-in, first-out basis and stated net of reserves at the
lower of cost or market. Inventory costs include direct materials, direct labor, and manufacturing
overhead. Supplies inventory related to research and development activities are expensed when
purchased.
We are dependent on our partners and vendors to provide raw materials, drugs and devices of
appropriate quality and reliability and to meet applicable regulatory requirements. Consequently,
in the event that supplies are delayed or interrupted for any reason, our ability to develop and
produce our products could be impaired, which could have a material adverse effect on our business,
financial condition and results of operation.
Property and Equipment
Property and equipment are stated at cost. Major improvements are capitalized, while
maintenance and repairs are expensed when incurred. Manufacturing, laboratory and other equipment
are depreciated using the straight-line method generally over estimated useful lives of three to
seven years. Leasehold improvements and buildings are depreciated using the straight-line method
over the shorter of the estimated useful life or the remaining term of the lease.
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, we periodically review our property and equipment for recoverability whenever events or
changes in circumstances indicate that the carrying value may not be recoverable. Generally, an
impairment loss would be recognized if the carrying amount of an asset exceeds the sum of the
discounted cash flows expected to result from the use and eventual disposal of the asset. Please
refer to Note 13 of Notes to Consolidated Financial Statements for additional information on the
impairment analysis performed.
Goodwill
Goodwill represents the excess of the price paid for another entity over the fair value of the
assets acquired and liabilities assumed in a business combination. We account for our goodwill
asset in accordance with SFAS No. 142, Goodwill and Other Intangible Assets (SFAS No. 142), and
test for impairment in the fourth quarter of each year using an October 1 measurement date, as well
as at other times when impairment indicators exists or when events occur or circumstances change
that would indicate the carrying amount may not be fully recoverable.
60
For purposes of our annual impairment test, we have identified and assigned goodwill to two
reporting units (as defined in SFAS No. 142): (1) pulmonary technology and (2) PEGylation and
advanced polymer conjugate technology. Goodwill is tested for impairment at the reporting unit
level using a two-step approach. The first step is to compare the fair value of a reporting units
net assets, including assigned goodwill, to the book value of its net assets, including assigned
goodwill. If the fair value of the reporting unit is greater than its net book value, the assigned
goodwill is not considered impaired. If the fair value is less than the reporting units net book
value, we perform a second step to measure the amount of the impairment, if any. The second step
would be to compare the book value of the reporting units assigned goodwill to the implied fair
value of the reporting units goodwill. As of December 31, 2008 and 2007, the carrying value of
our goodwill was $76.5 million and $78.4 million, respectively. Approximately $1.9 million of
goodwill allocated to our pulmonary reporting unit was included in the sale of certain pulmonary
assets to Novartis. There were no indications of impairment at December 31, 2008 or December 31,
2007.
Revenue Recognition
We recognize revenue in accordance with Securities and Exchange Commission Staff Accounting
Bulletin No. 104, Revenue Recognition in Financial Statements (SAB 104) and Emerging Issues Task
Force, Issue No. 00-21 (EITF 00-21), Revenue Arrangements with Multiple Deliverables.
Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery
has occurred, the price is fixed and determinable, and collection is reasonably assured. Allowances
are established for estimated sales returns and uncollectible amounts.
Product Sales and Royalty Revenue
Product sales are primarily derived from cost-plus manufacturing and supply agreements with
our collaboration partners, and revenue is recognized in accordance with the terms of the related
collaboration agreement. We have not experienced any significant returns from our customers.
Generally, we are entitled to royalties from our partners based on their net sales once their
products are approved for commercial sale. We recognize royalty revenue when the cash is received
or when the royalty amount to be received is estimable and collection is reasonably assured.
Collaboration and other revenue
Collaborative research and development arrangements
We enter into collaborative research and development arrangements with pharmaceutical and
biotechnology partners that may involve multiple deliverables. Our arrangements may contain the
following elements: upfront fees, collaborative research, milestone payments, manufacturing and
supply, royalties and license fees. The principles and guidance outlined in EITF No. 00-21 provide
a framework to (a) determine whether an arrangement involving multiple deliverables contains more
than one unit of accounting, and (b) determine how the arrangement consideration should be measured
and allocated to the separate units of accounting in the arrangement. Significant judgment is
required when determining the separate units of accounting and the fair value of individual
deliverables. For each separate unit of accounting we have objective and reliable evidence of fair
value using available internal evidence for the undelivered item(s) and our arrangements generally
do not contain a general right of return relative to the delivered item. We use the residual method
to allocate the arrangement consideration when it does not have fair value of a delivered item(s).
Under the residual method, the amount of consideration allocated to the delivered item equals the
total arrangement consideration less the aggregate fair value of the undelivered items.
Contract research revenue from collaborative research and development agreements is recorded
when earned based on the performance requirements of the contract. Advance payments for research
and development revenue received in excess of amounts earned are classified as deferred revenue
until earned. Amounts received under these arrangements are generally non-refundable even if the
research effort is unsuccessful.
Payments received for milestones achieved are deferred and recorded as revenue ratably over
the period of time from the achievement of milestone for which we received payment and our estimate
of the date on which the next milestone will be achieved. Management makes its best estimate of the
period of time until the next milestone is reached. This estimate affects the recognition of
revenue for completion of the previous milestone. The original estimate is periodically evaluated
to determine if circumstances have caused the estimate to change and if so, amortization of revenue
is adjusted prospectively. Final milestone payments are recorded and recognized upon achieving the
respective milestone, provided that collection is reasonably assured.
61
License Fee Revenue
We have granted licenses for certain of our intellectual property assets for use in developing
new molecules. We recognize revenue when delivery has occurred and we have no further performance
obligations. We consider delivery to have occurred when the license is granted on an exclusive
basis and the license is for the duration of the intellectual property life.
Exubera Commercialization Readiness Revenue
Exubera commercialization readiness revenue represents reimbursements from Pfizer, of certain
agreed upon operating costs relating to our Exubera inhalation powder manufacturing facilities and
our device contract manufacturing locations in preparation for commercial production, plus a markup
on such costs. Exubera commercialization readiness costs are start up manufacturing costs we have
incurred in our Exubera Inhalation Powder manufacturing facility and our Exubera Inhaler device
contract manufacturing locations in preparation for commercial production.
Shipping and Handling Costs
We record costs related to shipping and handling of product to customers in cost of goods
sold.
Stock-Based Compensation
Stock-based compensation arrangements covered by SFAS No. 123R, Share-Based Payment (SFAS No.
123R) currently include stock option grants and restricted stock unit (RSU) awards under our equity
incentive plans and purchases of common stock by our employees at a discount to the market price
under our Employee Stock Purchase Plan (ESPP). Under SFAS No. 123R, the value of the portion of the
option or award that is ultimately expected to vest is recognized as expense on a straight line
basis over the requisite service periods in our Consolidated Statements of Operations. Stock-based
compensation expense for purchases under the ESPP are recognized based on the estimated fair value
of the common stock during each offering period and the percentage of the purchase discount.
We use the Black-Scholes option valuation model adjusted for the estimated historical
forfeiture rate for the respective grant to determine the estimated fair value of our stock-based
compensation arrangements on the date of grant (grant date fair value) and expense this value
ratably over the service period of the option or performance period of the RSU award. Expense
amounts are allocated among inventory, cost of goods sold, research and development expenses, and
general and administrative expenses based on the function of the applicable employee. The
Black-Scholes option pricing model requires the input of highly subjective assumptions. Because our
employee stock options have characteristics significantly different from those of traded options,
and because changes in the subjective input assumptions can materially affect the fair value
estimate, in managements opinion, the existing models may not provide a reliable single measure of
the fair value of our employee stock options or common stock purchased under the ESPP. In addition,
management will continue to assess the assumptions and methodologies used to calculate estimated
fair value of stock-based compensation. Circumstances may change and additional data may become
available over time, which could result in changes to these assumptions and methodologies, and
which could materially impact our fair value determination.
Research and Development Expense
Research and development costs are expensed as incurred and include salaries, benefits and
other operating costs such as outside services, supplies and allocated overhead costs. We perform
research and development for our proprietary drug candidates and technology development and for
certain third parties under collaboration agreements. For our proprietary drug candidates and our
internal technology development programs, we invest our own funds without reimbursement from a
third party. Costs associated with treatment phase of clinical trials are accrued based on the
total estimated cost of the clinical trials and are expensed ratably based on patient enrollment in
the trials. Costs associated with the start-up and reporting phases of the clinical trials are
expensed ratably over the duration of the reporting and start-up phases.
Our collaboration agreements typically include a license to our intellectual property,
technology and clinical development support, and in certain cases, the manufacture and supply of
our proprietary drug components. Under these collaboration agreements, we may receive up-front
license fees, development cost reimbursement, clinical development and regulatory milestone
payments, fees for manufacturing our proprietary drug components, and royalties on sales if the
drug candidate receives regulatory approval. Many of our collaboration agreements are cancelable
by the partner without significant financial penalty.
62
On January 1, 2008, we adopted EITF No. 07-3, Accounting for Nonrefundable Advance Payments
for Goods or Services for Use in Future Research and Development Activities, which provides
guidance on the accounting for certain nonrefundable advance payments for goods or services that
will be used or rendered for future research and development activities. The adoption did not have
a material impact on our financial position or results of operations.
Net Loss Per Share
Basic net loss per share is calculated based on the weighted-average number of common shares
outstanding during the periods presented. For all periods presented in the Consolidated Statements
of Operations, the net loss available to common stockholders is equal to the reported net loss.
Basic and diluted net loss per share are the same due to our historical net losses and the
requirement to exclude potentially dilutive securities which would have an anti-dilutive effect on
net loss per share. The weighted average of these potentially dilutive securities has been excluded
from the diluted net loss per share calculation and is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Convertible subordinated notes |
|
|
13,804 |
|
|
|
15,781 |
|
|
|
16,896 |
|
Stock options |
|
|
14,147 |
|
|
|
11,108 |
|
|
|
8,901 |
|
Warrants |
|
|
|
|
|
|
|
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
27,951 |
|
|
|
26,889 |
|
|
|
25,810 |
|
|
|
|
|
|
|
|
|
|
|
Income Taxes
We account for income taxes under the liability method in accordance with SFAS No. 109,
Accounting for Income Taxes (SFAS No. 109), and FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income TaxesAn Interpretation of FASB Statement No. 109. Under this method,
deferred tax assets and liabilities are determined based on differences between financial reporting
and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws
that are expected to be in effect when the differences are expected to reverse. Realization of
deferred tax assets is dependent upon future earnings, the timing and amount of which are
uncertain.
FIN 48 contains a two-step approach to recognizing and measuring uncertain tax positions. The
first step is to evaluate the tax position for recognition by determining if the weight of
available evidence indicates that it is more likely than not that the position will be sustained
upon tax authority examination, including resolution of related appeals or litigation processes, if
any. The second step is to measure the tax benefit as the largest amount that is more than 50%
likely of being realized upon ultimate settlement.
We adopted FIN 48 on January 1, 2007. Upon adoption, we did not recognize an increase or a
decrease in the liability for net unrecognized tax benefits, which would be accounted for through
retained earnings.
We have incurred net operating losses since inception and we do not have any significant
unrecognized tax benefits. Our policy is to include interest and penalties related to unrecognized
tax benefits, if any, within the provision for taxes in the consolidated statements of operations.
If we are eventually able to recognize our uncertain positions, our effective tax rate would be
reduced. We currently have a full valuation allowance against our net deferred tax asset which
would impact the timing of the effective tax rate benefit should any of these uncertain tax
positions be favorably settled in the future. Any adjustments to our uncertain tax positions would
result in an adjustment of our net operating loss or tax credit carry forwards rather than
resulting in a cash outlay.
We file income tax returns in the U.S., California and other states, and various foreign
jurisdictions. We are currently not the subject of any income tax examinations. In general, the
earliest open year subject to examination is 2004, although depending upon jurisdiction, tax years
may remain open, subject to certain limitations.
Recent Accounting Pronouncements
FASB Statement of Position No. 157-2
In February 2008, the FASB issued FASB Staff Position 157-2, Effective Date of FASB Statement
No. 157 (FSP 157-2), which delays the effective date of SFAS No. 157 to fiscal years beginning
after November 15, 2008, for all nonfinancial assets and nonfinancial liabilities, except for items
that are recognized or disclosed at fair value in the financial statements on a recurring basis (at
least annually). In accordance with FSP 157-2, the fair value measurements for non-financial
assets and liabilities is required to be adopted effective for fiscal years beginning after
November 15, 2008 We believe the adoption of the delayed items of SFAS No. 157 will not have a
material impact on our financial statements.
63
EITF 07-1
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which defines collaborative arrangements and establishes reporting and disclosure
requirements for transactions between participants in a collaborative arrangement and between
participants in the arrangements and third parties. This issue is effective retrospectively to all
prior periods presented for all collaborative arrangements existing as of the effective date for
fiscal years beginning after December 15, 2008. We believe the adoption of EITF 07-1 will not
have a material impact on our financial statements.
FSP APB 14-1
In May 2008, the FASB issued FSP Accounting Principles Board 14-1 Accounting for Convertible
Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)
(FSP APB 14-1). FSP APB 14-1 addresses instruments commonly referred to as Instrument C from EITF
90-19, which requires the issuer to settle the principal amount in cash and the conversion spread
in cash or net shares at the issuers option. FSP APB 14-1 requires the issuer of these
instruments account for the liability (debt) and equity (conversion option) components of the
instrument in a manner that reflects the issuers nonconvertible debt borrowing rate. FSP APB 14-1
is effective for fiscal years beginning after December 15, 2008 and interim periods within those
fiscal years on a retroactive basis. Early application is not permitted. The noteholders may
convert outstanding convertible subordinated notes to shares of our common stock only, therefore we
do not expect FSP APB 14-1 to have a material impact on our financial position or results of
operations.
Note 2Cash, Cash Equivalents, and Available-For-Sale Investments
Cash, cash equivalents, and available-for-sale investments are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
December 31, 2008 |
|
|
December 31, 2007 |
|
Cash and cash equivalents |
|
$ |
155,584 |
|
|
$ |
76,293 |
|
Short-term investments (less than one year to maturity) |
|
|
223,410 |
|
|
|
406,060 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
378,994 |
|
|
$ |
482,353 |
|
|
|
|
|
|
|
|
Our portfolio of cash, cash equivalents, and available-for-sale investments includes (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
December 31, 2008 |
|
|
December 31, 2007 |
|
U.S. corporate commercial paper |
|
$ |
115,658 |
|
|
$ |
293,866 |
|
Obligations of U.S. corporations |
|
|
26,275 |
|
|
|
100,727 |
|
Obligations of U.S. government agencies |
|
|
91,667 |
|
|
|
37,333 |
|
Cash and money market funds |
|
|
145,394 |
|
|
|
50,427 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
378,994 |
|
|
$ |
482,353 |
|
|
|
|
|
|
|
|
The primary objective of our investment activities is to preserve principal while at the same
time maximizing yields without significantly increasing risk. To achieve this objective, we invest
in liquid, high quality debt securities. Our investments in debt securities are subject to interest
rate risk. To minimize the exposure due to an adverse shift in interest rates, we invest in
short-term securities and maintain a weighted average maturity of one year or less. At December
31, 2008, the average portfolio duration was approximately two months and the contractual maturity
of any single investment did not exceed twelve months. At December 31, 2007, the average portfolio
duration was approximately four months and the contractual maturity of any single investment did
not exceed twelve months
Gross unrealized gains and losses were insignificant at December 31, 2008 and at December 31,
2007. The gross unrealized losses were primarily due to changes in interest rates on fixed income
securities. We have a history of holding our investments to maturity and we have the ability and
intent to hold our debt securities to maturity when they will be redeemed at full par value.
Accordingly, we consider these unrealized losses to be temporary and have not recorded a provision
for impairment.
During the year ended December 31, 2008, we sold available-for-sale securities to fund our
convertible subordinated note repurchase. We received proceeds from these sales totaling $70.1
million and realized a gain of $0.1 million in the income statement for the year period ended
December 31, 2008.
64
At December 31, 2008 and 2007, we had letter of credit arrangements with certain financial
institutions and vendors, including our landlord, totaling $2.9 million and $2.8 million,
respectively. These letters of credit are secured by investments of similar amounts.
The following table represents the fair value hierarchy for our financial assets measured at
fair value on a recurring basis as of December 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
134,686 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
134,686 |
|
U.S. corporate commercial paper |
|
|
|
|
|
|
115,658 |
|
|
|
|
|
|
|
115,658 |
|
Obligations of U.S. corporations |
|
|
|
|
|
|
26,275 |
|
|
|
|
|
|
|
26,275 |
|
Obligations of U.S. government agencies |
|
|
|
|
|
|
91,667 |
|
|
|
|
|
|
|
91,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents and available-for-sale investments |
|
$ |
134,686 |
|
|
$ |
233,600 |
|
|
$ |
|
|
|
$ |
368,286 |
|
Cash |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, Cash equivalents, and available-for-sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
378,994 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1Quoted prices in active markets for identical assets or liabilities.
Level 2Inputs other than Level 1 that are observable, either directly or indirectly, such as
quoted prices for similar assets or liabilities; quoted prices in markets that are not active;
or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level 3Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
Note 3Inventory
Inventory consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
6,964 |
|
|
$ |
9,522 |
|
Work-in-process |
|
|
1,743 |
|
|
|
1,749 |
|
Finished goods |
|
|
612 |
|
|
|
916 |
|
|
|
|
|
|
|
|
Total |
|
$ |
9,319 |
|
|
$ |
12,187 |
|
|
|
|
|
|
|
|
Inventory consists of raw materials, work-in-process, and finished goods for our commercial
PEGylation business.
Reserves are determined using specific identification plus an estimated reserve for potential
defective or excess inventory based on historical experience or projected usage. Inventories are
reflected net of reserves of $5.0 million and $5.8 million as of December 31, 2008 and 2007,
respectively.
Note 4Property and Equipment
Property and equipment consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Building and leasehold improvements |
|
$ |
62,260 |
|
|
$ |
114,210 |
|
Laboratory equipment |
|
|
24,549 |
|
|
|
48,425 |
|
Manufacturing equipment |
|
|
8,682 |
|
|
|
18,493 |
|
Furniture, fixtures and other equipment |
|
|
14,717 |
|
|
|
21,169 |
|
Construction-in-progress |
|
|
6,875 |
|
|
|
18,374 |
|
|
|
|
|
|
|
|
Property and equipment at cost |
|
$ |
117,083 |
|
|
$ |
220,671 |
|
|
|
|
|
|
|
|
Less: accumulated depreciation |
|
|
( 43,505 |
) |
|
|
(106,251 |
) |
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
73,578 |
|
|
$ |
114,420 |
|
|
|
|
|
|
|
|
Building and leasehold improvements include our commercial manufacturing, clinical
manufacturing, research and development and administrative facilities and the related improvements
to these facilities. Laboratory and manufacturing equipment includes assets that support both our
manufacturing and research and development efforts. Construction-in-progress includes assets being
built to enhance our manufacturing and research and development programs. Property and equipment
includes assets acquired through capital leases, please refer to Note 6 of Notes to Consolidated
Financial Statements for additional information on assets acquired through capital leases. During
the year ended December 31, 2008, we capitalized $1.9 million of purchased software costs, which
are included in furniture, fixtures and other equipment.
65
Depreciation expense, including depreciation of assets acquired through capital leases, for
the years ended December 31, 2008, 2007, and 2006 was $19.8 million, $25.9 million, and $26.8
million, respectively.
On December 31, 2008, we sold certain assets and obligations related to our pulmonary
technology, development and manufacturing operations to Novartis Pharmaceuticals Corporation and
Novartis Pharma AG (together referred to as Novartis), including property and equipment with a
gross book value of $108.0 million, accumulated depreciation of $70.7 million, and a net book value
of $37.3 million. Please refer to Note 11 of Notes to Consolidated Financial Statements for
additional information related to the sale of certain pulmonary assets to Novartis.
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, we periodically review our Property and Equipment for recoverability whenever events or
changes in circumstances indicate that the carrying value may not be recoverable. During the years
ended December 31, 2008, 2007, and 2006, we recorded impairment charges on our Property and
Equipment of $1.5 million for a specialized dryer in our PEGylation commercial manufacturing
facility, $28.4 million for Exubera-related property and equipment, and $2.8 million for our
property and equipment at Bradford, UK due to shut down of its operations, respectively. Please
refer to Note 13 of Notes to Consolidated Financial Statements for additional information related
to Impairment of Long-Lived Assets.
Note 5Convertible Subordinated Notes
The outstanding balance of our convertible subordinated notes is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Semi-Annual |
|
|
December 31, |
|
|
|
Interest Payment Dates |
|
|
2008 |
|
|
2007 |
|
3.25% Notes due September 2012 |
|
March 28, September 28 |
|
$ |
214,955 |
|
|
$ |
315,000 |
|
Our convertible subordinated notes are unsecured and subordinated in right of payment to any
future senior debt. Costs related to the issuance of these convertible notes are recorded in other
assets in our Consolidated Balance Sheets and are generally amortized to interest expense on a
straight-line basis over the contractual life of the notes. The unamortized deferred financing
costs were $2.2 million and $5.1 million as of December 31, 2008 and 2007, respectively.
Gain on Extinguishment of Debt
During the fourth quarter of 2008, we repurchased $100.0 million of our 3.25% notes for $47.8
million. The recognized gain on debt extinguishment of $50.1 million is net of transaction costs
of $1.0 million and accelerated amortization of deferred financing costs of $1.1 million.
Conversion and Redemption
The notes are convertible at the option of the holder at any time on or prior to maturity into
shares of our common stock. The 3.25% Notes have a conversion rate of 46.4727 shares per $1,000
principal amount, which is equal to a conversion price of approximately $21.52. Additionally, at
any time prior to maturity, if a fundamental change as defined in the 3.25% subordinated debt
indenture occurs, we may be required to pay a make-whole premium on notes converted in connection
therewith by increasing the conversion rate applicable to the notes.
We may redeem the 3.25% Notes in whole or in part for cash at a redemption price equal to 100%
of the principal amount of the Notes plus any accrued but unpaid interest if the closing price of
the common stock has exceeded 150% of the conversion price for at least 20 days in any consecutive
30 day trading period.
66
Note 6Capital Leases
We lease office space and office equipment under capital lease arrangements. The gross
carrying value by major asset class and accumulated depreciation included in Property and equipment
as of December 31, 2008 and 2007 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Building and leasehold improvements |
|
$ |
23,962 |
|
|
$ |
23,962 |
|
Furniture, fixtures and other equipment |
|
|
261 |
|
|
|
591 |
|
Construction in progress |
|
|
|
|
|
|
1,602 |
|
|
|
|
|
|
|
|
Total assets recorded under capital leases |
|
$ |
24,223 |
|
|
$ |
26,155 |
|
Less: accumulated depreciation |
|
|
(8,050 |
) |
|
|
(6,124 |
) |
|
|
|
|
|
|
|
Net assets recorded under capital leases |
|
$ |
16,173 |
|
|
$ |
20,031 |
|
|
|
|
|
|
|
|
Building Lease
We lease office space at 201 Industrial Road in San Carlos, California under capital lease
arrangements. During the year ended December 31, 2007, we modified our existing lease agreement to
increase our office space by 20,123 square feet of additional premises. We re-evaluated the lease
as amended and continue to classify it as a capital lease.
Under the terms of the lease, the rent will escalate 2% in October of each year for the
original leased premises and the rent will escalate 3% in November of each year for the additional
leased premises. The lease termination date for the original and additional premises is October 5,
2016.
Office Equipment
In November 2007, we entered into a twelve-month lease with Cisco Systems Capital Corporation
related to communication equipment. In October 2008, the lease term ended and we purchased the
equipment for $1.
Future Minimum Lease Payments
Future minimum payments for our capital leases at December 31, 2008 are as follows (in
thousands):
|
|
|
|
|
Years ending December 31, |
|
|
|
|
2009 |
|
$ |
4,717 |
|
2010 |
|
|
4,752 |
|
2011 |
|
|
4,907 |
|
2012 |
|
|
4,958 |
|
2013 |
|
|
5,064 |
|
2014 and thereafter |
|
|
14,424 |
|
|
|
|
|
Total minimum payments required |
|
$ |
38,822 |
|
Less: amount representing interest |
|
|
(17,190 |
) |
|
|
|
|
Present value of future payments |
|
$ |
21,632 |
|
Less: current portion |
|
|
(1,285 |
) |
|
|
|
|
Non-current portion |
|
$ |
20,347 |
|
|
|
|
|
Note 7Litigation Settlement
On June 30, 2006, we, our subsidiary Nektar AL, and a former officer, Milton Harris, entered
into a settlement agreement and general release with the University of Alabama, Huntsville (UAH)
related to an intellectual property dispute. Under the terms of the settlement agreement, we,
Nektar AL, Mr. Harris and UAH agreed to full and complete satisfaction of
all claims asserted in the litigation in exchange for $25.0 million in cash payments. We and
Mr. Harris made an initial payment of $15.0 million on June 30, 2006, of which we paid $11.0
million and Mr. Harris paid $4.0 million. During the year ended December 31, 2006, we recorded a
litigation settlement charge of $17.7 million, which reflects the net present value of the
settlement payments using an 8% annual discount rate. In June 2007 and 2008, respectively, we paid
our annual $1.0 million installment payments. As of December 31, 2008, our accrued liability
related to the UAH settlement was $6.0 million, which is the net present value of our eight annual
$1.0 million payments remaining.
67
Note 8Commitments and Contingencies
Unconditional Purchase Obligations
As of December 31, 2008, we had approximately $17.0 million of unconditional purchase
obligations for purchases of goods and services in 2009 that have not been recognized on our
consolidated balance sheet. These obligations include approximately $6.5 million for research and
development activities pertaining to our ongoing proprietary development of NKTR-102, NKTR-105,
and NKTR-118, $3.4 million for early research activities pertaining to PEGylation and advanced
polymer conjugate drug candidates, $2.7 million for capital projects to enhance our manufacturing
capabilities, research and development programs, and facilities, $1.4 million for inventory
purchases related to PEGylation and advanced polymer conjugate programs, and $2.0 million for
partnered contract research programs.
Royalty Expense
We have certain royalty commitments associated with the shipment and licensing of certain
products. Royalty expense, which is reflected in cost of goods sold in our Consolidated Statements
of Operations, was approximately $4.8 million, $3.9 million, and $5.5 million for the years ended
December 31, 2008, 2007, and 2006, respectively. The overall maximum amount of the obligations is
based upon sales of the applicable product and cannot be reasonably estimated.
Operating Leases
For the years ended December 31, 2008, 2007, and 2006, rent expense for operating leases was
approximately $3.5 million, $4.3 million, and $4.1 million.
We were a party of an operating lease for our San Carlos manufacturing facility through 2012.
On December 31, 2008, this operating lease was assigned to Novartis Pharmaceuticals Inc as part of
the pulmonary asset sale. We have no further liabilities related to this lease.
Legal Matters
From time to time, we may be involved in lawsuits, claims, investigations and proceedings,
consisting of intellectual property, commercial, employment and other matters, which arise in the
ordinary course of business. In accordance with the SFAS No. 5, Accounting for Contingencies, we
make a provision for a liability when it is both probable that a liability has been incurred and
the amount of the loss can be reasonably estimated. These provisions are reviewed at least
quarterly and adjusted to reflect the impact of negotiations, settlements, ruling, advice of legal
counsel, and other information and events pertaining to a particular case. Litigation is inherently
unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the
possibility of a material adverse impact on the results of operations of that period or on our cash
flows and liquidity.
Indemnifications in Connection with Commercial Agreements
As part of our collaboration agreement with our partners related to the license, development,
manufacture and supply of drugs based on our proprietary technologies, we generally agree to
defend, indemnify and hold harmless our partners from and against third party liabilities arising
out of the agreement, including product liability (with respect to our activities) and infringement
of intellectual property to the extent the intellectual property is developed by us and licensed to
our partners. The term of these indemnification obligations is generally perpetual any time after
execution of the agreement. There is generally no limitation on the potential amount of future
payments we could be required to make under these indemnification obligations.
As part of our pulmonary asset sale to Novartis that closed on December 31, 2008, we and
Novartis made representations and warranties and entered into certain covenants and ancillary
agreements which are supported by an indemnity obligation. In the event it were determined that we
breached any of the representations and warranties or covenants and agreements made by us in the
transaction documents, we could incur an indemnification liability depending on the timing, nature,
and amount of any such claims.
68
To date we have not incurred costs to defend lawsuits or settle claims related to these
indemnification obligations. If any of our indemnification obligations is triggered, we may incur
substantial liabilities. Because the obligated amount under these agreements is not explicitly
stated, the overall maximum amount of the obligations cannot be reasonably estimated. No
liabilities have been recorded for these obligations on our Consolidated Balance Sheets as of
December 31, 2008 or 2007.
Indemnification of Underwriters and Initial purchasers of our Securities
In connection with our sale of equity and convertible debt securities, we have agreed to
defend, indemnify and hold harmless our underwriters or initial purchasers, as applicable, as well
as certain related parties from and against certain liabilities, including liabilities under the
Securities Act of 1933, as amended. The term of these indemnification obligations is generally
perpetual. There is no limitation on the potential amount of future payments we could be required
to make under these indemnification obligations. We have never incurred costs to defend lawsuits or
settle claims related to these indemnification obligations. If any of our indemnification
obligations are triggered, however, we may incur substantial liabilities. Because the obligated
amount of this agreement is not explicitly stated, the overall maximum amount of the obligations
cannot be reasonably estimated. Historically, we have not been obligated to make significant
payments for these obligations, and no liabilities have been recorded for these obligations in our
Consolidated Balance Sheets as of December 31, 2008 or 2007.
Director and Officer Indemnifications
As permitted under Delaware law, and as set forth in our Certificate of Incorporation and our
Bylaws, we indemnify our directors, executive officers, other officers, employees, and other agents
for certain events or occurrences that arose while in such capacity. The maximum potential amount
of future payments we could be required to make under this indemnification is unlimited; however,
we have insurance policies that may limit our exposure and may enable us to recover a portion of
any future amounts paid. Assuming the applicability of coverage, the willingness of the insurer to
assume coverage, and subject to certain retention, loss limits and other policy provisions, we
believe any obligations under this indemnification are not material, other than an initial $500,000
per incident for securities related claims and $250,000 per incident for non-securities related
claims retention deductible per our insurance policy. However, no assurances can be given that the
covering insurers will not attempt to dispute the validity, applicability, or amount of coverage
without expensive litigation against these insurers, in which case we may incur substantial
liabilities as a result of these indemnification obligations. Because the obligated amount of this
agreement is not explicitly stated, the overall maximum amount of the obligations cannot be
reasonably estimated. Historically, we have not been obligated to make significant payments for
these obligations, and no liabilities have been recorded for these obligations in our Consolidated
Balance Sheets as of December 31, 2008 or 2007.
Note 9Stockholders Equity
Preferred Stock
We have authorized 10,000,000 shares of Preferred Stock, each share having a par value of
$0.0001. Of these shares, 3,100,000 shares are designated Series A Junior Participating Preferred
Stock (Series A Preferred Stock). The remaining shares are undesignated. We have no preferred
shares issued and outstanding as of December 31, 2008 or 2007.
Series A Preferred Stock
On June 1, 2001, the Board of Directors approved the adoption of a Share Purchase Rights Plan.
Terms of the Rights Plan provide for a dividend distribution of one preferred share purchase right
for each outstanding share of our Common Stock. The Rights have certain anti-takeover effects and
will cause substantial dilution to a person or group that attempts to acquire us on terms not
approved by our Board of Directors. The dividend distribution was payable on June 22, 2001, to the
stockholders of record on that date. Each Right entitles the registered holder to purchase from us
one one-hundredth of a share of Series A Preferred Stock at a price of $225.00 per one
one-hundredth of a share of Series A Preferred Stock, subject
to adjustment. Each one one-hundredth of a share of Series A Preferred Stock has designations
and powers, preferences and rights, and the qualifications, limitations and restrictions which make
its value approximately equal to the value of a share of Common Share.
The Rights are not exercisable until the Distribution Date (as defined in the Certificate of
Designation for the Series A Preferred Stock). The Rights will expire on June 1, 2011, unless the
Rights are earlier redeemed or exchanged by us. Each share of Series A Preferred Stock will be
entitled to a minimum preferential quarterly dividend payment of $1.00, or if greater than $1.00,
will be entitled to an aggregate dividend of 100 times the dividend declared per share of Common
Stock. In the event of liquidation, the holders of the Series A Preferred Stock would be entitled
to $100 per share or, if greater than $100, an aggregate payment equal to 100 times the payment
made per share of Common Stock. Each share of Series A Preferred Stock will have 100 votes, voting
together with the Common Stock. Finally, in the event of any merger, consolidation or other
transaction in which our Common Stock is exchanged, each share of Series A Preferred Stock will be
entitled to receive 100 times the amount of consideration received per share of Common Stock.
Because of the nature of the Series A Preferred Stock dividend and liquidation rights, the value of
one one-hundredth of a share of Series A Preferred Stock should approximate the value of one share
of Common Stock. The Series A Preferred Stock would rank junior to any other future series of
preferred stock. Until a Right is exercised, the holder thereof, as such, will have no rights as a
stockholder, including, without limitation, the right to vote or to receive dividends.
69
Reserved Shares
At December 31, 2008, we have reserved shares of common stock for issuance as follows (in
thousands):
|
|
|
|
|
|
|
As of December 31, 2008 |
|
Convertible subordinated notes |
|
|
9,989 |
|
Option Plans |
|
|
28,922 |
|
ESPP |
|
|
161 |
|
401(k) retirement plans |
|
|
220 |
|
|
|
|
|
Total |
|
|
39,292 |
|
|
|
|
|
Stock Option Plans
The following table summarizes information with respect to shares of our common stock that may
be issued under our existing equity compensation plans as of December 31, 2008 (share number in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities remaining |
|
|
|
|
|
|
|
|
|
|
|
available for issuance under |
|
|
|
Number of securities to be |
|
|
Weighted-average |
|
|
equity compensation plans |
|
|
|
issued upon exercise of |
|
|
exercise price of |
|
|
(excluding securities reflected |
|
|
|
outstanding options |
|
|
outstanding options |
|
|
in column(a)) |
|
Plan Category |
|
(a) (1) |
|
|
(b) |
|
|
(c) |
|
Equity compensation
plans approved by
security holders
(2) |
|
|
7,833 |
|
|
$ |
12.53 |
|
|
|
12,443 |
|
Equity compensation
plans not approved
by security holders |
|
|
5,948 |
|
|
$ |
11.66 |
|
|
|
2,827 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
13,781 |
|
|
$ |
12.16 |
|
|
|
15,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Does not include options 31,738 shares we assumed in connection with the acquisition of
Shearwater Corporation (with a weighted-average exercise price of $0.03 per share). |
|
(2) |
|
Includes shares of common stock available for future issuance under our ESPP as of December
31, 2008. |
2008 Equity Incentive Plan
Our 2008 Equity Incentive Plan (2008 Plan) was adopted by the Board of Directors on March 20,
2008 and was approved by our stockholders on June 6, 2008. The purpose of the 2008 Equity Incentive
Plan is to attract and retain qualified personnel, to provide additional incentives to our
employees, officers, consultants and employee directors and to promote the
success of our business. Pursuant to the 2008 Plan, we may grant or issue incentive stock
options to employees and officers and non-qualified stock options, rights to acquire restricted
stock, restricted stock units, and stock bonuses to consultants, employees, officers and
non-employee directors.
The maximum number of shares of our common stock that may be issued or transferred pursuant to
awards under the 2008 Plan is 9,000,000 shares. Shares issued in respect of any stock bonus or
restricted stock award granted under the 2008 Plan will be counted against the plans share limit
as 1.5 shares for every one share actually issued in connection with the award. The 2008 Plan will
terminate on March 20, 2018, unless earlier terminated by the Board.
The maximum term of a stock option under the 2008 Equity Incentive Plan is eight years, but if
the optionee at the time of grant has voting power of more than 10% of our outstanding capital
stock, the maximum term of an incentive stock option is five years. The exercise price of stock
options granted under the 2008 Plan must be at least equal to 100% (or 110% with respect to holders
of more than 10% of the voting power of our outstanding capital stock) of the fair market value of
the stock subject to the option as determined by the closing price of our common stock on the
Nasdaq Global Market on the date of grant.
70
To the extent that shares are delivered pursuant to the exercise of a stock option, the number
of underlying shares as to which the exercise related shall be counted against the applicable share
limits of the 2008 Plan, as opposed to only counting the shares actually issued. Shares that are
subject to or underlie awards which expire or for any reason are cancelled or terminated, are
forfeited, fail to vest or for any other reason are not paid or delivered under the 2008 Plan will
again be available for subsequent awards under the 2008 Plan.
2000 Equity Incentive Plan
On April 19, 2000 the Board of Directors adopted our 2000 Equity Incentive Plan (2000 Plan) by
amending and restating our 1994 Equity Incentive Plan. The purpose of the 2000 Equity Incentive
Plan is to attract and retain qualified personnel, to provide additional incentives to our
employees, officers, consultants and employee directors and to promote the success of our business.
Pursuant to the 2000 Plan, we may grant or issue incentive stock options to employees and officers
and non-qualified stock options, rights to acquire restricted stock, restricted stock units, and
stock bonuses to consultants, employees, officers and non-employee directors.
The maximum term of a stock option under the 2000 Plan is eight years, but if the optionee at
the time of grant has voting power of more than 10% of our outstanding capital stock, the maximum
term of an incentive stock option is five years. The exercise price of incentive stock options
granted under the 2000 Equity Incentive Plan must be at least equal to 100% (or 110% with respect
to holders of more than 10% of the voting power of our outstanding capital stock) of the fair
market value of the stock subject to the option as determined by the closing price of our common
stock on the Nasdaq Global Market on the date of grant.
The Board may amend the 2000 Plan at any time, although certain amendments would require
stockholder approval. The 2000 Plan will terminate on February 9, 2010, unless earlier terminated
by the Board. On June 1, 2006, our stockholders approved an amendment to the 2000 Plan to increase
the number of shares of Common Stock authorized for issuance under the Purchase Plan to a total of
18,250,000 shares.
2000 Non-Officer Equity Incentive Plan
Our 1998 Non-Officer Equity Incentive Plan was adopted by the Board of Directors on August 18,
1998, and was amended and restated in its entirety and renamed the 2000 Non-officer Equity
Incentive Plan on June 6, 2000 ( 2000 Non-Officer Plan). The purpose of the 2000 Non-Officer Plan
is to attract and retain qualified personnel, to provide additional incentives to employees and
consultants and to promote the success of our business. Pursuant to the 2000 Non-Officer Plan, we
may grant or issue non-qualified stock options, rights to acquire restricted stock and stock
bonuses to employees and consultants who are neither Officers nor Directors of Nektar. The maximum
term of a stock option under the 2000 Non-Officer Plan is eight years. The exercise price of stock
options granted under the 2000 Non-Officer Plan are determined by the Board of Directors by
reference to closing price of our common stock on the Nasdaq Global Market.
Non-Employee Directors Stock Option Plan
On February 10, 1994, our Board of Directors adopted the Non-Employee Directors Stock Option
Plan under which options to purchase up to 400,000 shares of our Common Stock at the then fair
market value may be granted to our non-employee directors. There are no remaining options available
for grant under this plan as of December 31, 2008.
Restricted Stock Units
During the years ended December 31, 2008, 2007 and 2006, we issued Restricted Stock Unit
awards (RSU awards) to certain officers, non-employees, directors, employees and consultants. RSU
awards are similar to restricted stock in that they are issued for no consideration; however, the
holder generally is not entitled to the underlying shares of common stock until the RSU award
vests. Also, because the RSU awards are issued for $0.01, the grant-date fair value of the award is
equal to the intrinsic value of our common stock on the date of grant. The RSU awards were issued
under both the 2000 Plan and the 2000 Non-Officer Plan and are settled by delivery of shares of our
common stock on or shortly after the date the awards vest.
We issued approximately 48,000, 345,000 and 1,089,000 RSU awards during the years ended
December 31, 2008, 2007 and 2006. The RSU awards issued in 2008 and 2007 are service based awards
and vest based on the passage of time. Approximately 1,010,000 of the RSU awards issued in 2006
vest upon the achievement of three performance-based milestones. During the year ended December 31,
2007, one of the performance based milestones was achieved and 174,035 shares vested and were
released. Beginning with shares granted in the year ended December 31, 2005, each RSU award
depletes the pool of options available for grant under our equity incentive plans by a ratio of
1:1.5.
71
Employee Stock Purchase Plan
In February 1994, our Board of Directors adopted the Employee Stock Purchase Plan (ESPP),
pursuant to section 423(b) of the Internal Revenue Code of 1986. Under the ESPP, 800,000 shares of
common stock have been authorized for issuance. The terms of the ESPP provide eligible employees
with the opportunity to acquire an ownership interest in Nektar through participation in a program
of periodic payroll deductions for the purchase of our common stock. Employees may elect to enroll
or re-enroll in the plan on a semi-annual basis. Stock is purchased at 85% of the lower of the
closing price on the first day of the enrollment period or the last day of the enrollment period.
401(k) Retirement Plan
We sponsored a 401(k) retirement plan whereby eligible employees may elect to contribute up to
the lesser of 60% of their annual compensation or the statutorily prescribed annual limit allowable
under Internal Revenue Service regulations. The 401(k) plan permits us to make matching
contributions on behalf of all participants.
An amendment was made to the current 401(k) plan, effective January 1, 2008, to provide each
eligible participant with a base employer matching cash contribution of $1,000 and up to an
additional $2,000 in matching cash contributions (for a maximum aggregate of $3,000). The base
annual employer matching contribution of $1,000 accrues to the participant for participating at any
level in the 401(k) plan during the calendar year. The additional matching contribution accrues to
the participant on a $1 for $1 basis based upon each participants annual contribution to the
401(k) plan. In order for a participant to be eligible for any amount of the employer contribution
match, the participant must be an employee at the end of the calendar year. If the participant
commences employment during the calendar year, the base matching contribution will be pro-rated
based on the number of calendar quarters the participant is employed during the year. Both the
base and additional employer matching contribution are 100% vested on the date of the match.
In 2007 and 2006, we matched the lesser of 75% of year to date participant contributions or 3%
of eligible wages. The matching contribution is in the form of shares of our common stock
Vesting of the employer match, plus actual earnings thereon, is based on years of service.
Participants vest 33% in employer matching contributions each year with 100% vesting after three
years of service.
We issued approximately 161,000 shares and 103,000 shares of our common stock valued at
approximately $1.6 million and $1.8 million in connection with the employer matching common stock
contributions in 2007 and 2006 respectively. During part of 2007, shares reserved for issuance
related to matching contributions that had been previously been approved by our Board of Directors
became fully depleted. During the year ended December 31, 2007, our Board of Directors approved an
additional 300,000 shares to be reserved for issuance related to matching contributions.
Change in Control Severance Plan
On December 6, 2006, the Board of Directors approved a Change of Control Severance Benefit
Plan (CIC Plan) and on February 14, 2007 and October 21, 2008, the Board of Directors amended and
restated the CIC Plan. The CIC Plan is designed to make certain benefits available to eligible
employees of the Company in the event of a change of control of the Company and, following such
change of control, an employees employment with the Company or successor company is terminated in
certain specified circumstances. We adopted the CIC Plan to support the continuity of the business
in the context of a change of control transaction. The CIC Plan was not adopted in contemplation of
any specific change of control transaction. A brief description of the material terms and
conditions of the CIC Plan is provided below.
Under the CIC Plan, in the event of a change of control of the Company and a subsequent
termination of employment initiated by the Company or a successor company other than for Cause or
initiated by the employee for a Good Reason Resignation (as hereinafter defined) in each case
within twelve months following a change of control transaction, (i) the Chief Executive Officer
would be entitled to receive cash severance pay equal to 24 months base salary plus annual target
incentive pay, the extension of employee benefits over this severance period and the full
acceleration of unvested outstanding equity awards, and (ii) the Senior Vice Presidents and Vice
Presidents (including Principal Fellows) would each be entitled to receive cash severance pay equal
to twelve months base salary plus annual target incentive pay, the extension of employee benefits
over this severance period and the full acceleration of unvested outstanding equity awards. In the
event of a change of control of the Company and a subsequent termination of employment initiated by
the Company or a successor company other than for Cause (as hereinafter defined) within twelve
months following a change of control transaction, all other employees would each be entitled to
receive cash severance pay equal to 6 months base salary plus annual target incentive pay, the
extension of employee benefits over this severance period and the full acceleration of each such
employees unvested outstanding equity awards.
72
On December 6, 2006, the Board of Directors approved an amendment to all outstanding stock
awards held by non-employee directors to provide for full acceleration of vesting in the event of a
change of control transaction.
Note 10Collaborative Agreements
We have entered into various license and collaborative research and development agreements
with pharmaceutical and biotechnology companies. Under these arrangements, we are entitled to
receive license fees, up-front payments, milestone payments when and if certain development or
regulatory milestones are achieved, and/or reimbursement for research and development activities.
All of our research and development agreements are generally cancelable by our partners without
significant financial penalty to the partner. Revenues generated from our collaboration agreements
are recorded as Collaboration and other revenue and our costs of performing these services are
included in Research and development expense.
In accordance with these agreements, we recorded Collaboration and other revenue as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
Partner |
|
Agreement |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Novartis Vaccines and Diagnostics, Inc. |
|
Tobramycin inhalation powder (TIP) |
|
$ |
13,723 |
|
|
$ |
17,036 |
|
|
$ |
8,516 |
|
Bayer Schering Pharma AG |
|
Cipro Inhale |
|
|
11,653 |
|
|
|
8,116 |
|
|
|
4,884 |
|
Bayer Healthcare LLC |
|
BAY41-6651 (NKTR-061, Amikacin Inhale) |
|
|
10,054 |
|
|
|
1,306 |
|
|
|
|
|
Pfizer Inc. |
|
Exubera® inhalation powder |
|
|
|
|
|
|
49,490 |
|
|
|
33,674 |
|
|
|
Next-generation inhaled insulin (NGI) |
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
13,500 |
|
|
|
16,324 |
|
|
|
17,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and other revenue |
|
|
|
$ |
48,930 |
|
|
$ |
92,272 |
|
|
$ |
64,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Novartis Vaccines and Diagnostics, Inc.
Tobramycin inhalation powder (TIP)
We were party to a collaborative research, development and commercialization agreement with
Novartis Vaccines and Diagnostics, Inc. related to the development of Tobramycin inhalation powder
(TIP) for the treatment of lung infections caused by the bacterium Pseudomonas aeruginosa in cystic
fibrosis patients. We were reimbursed for the cost of work performed on a revenue per annual
full-time equivalent (FTE) basis, plus out of pocket third party costs. Revenue recognized
approximates the cost associated with these billable services. We recognized $13.2 million,
$17.0 million, and $8.5 million in reimbursed research and development revenue during the years
ended December 31, 2008, 2007, and 2006.
Our collaborative research, development and commercialization agreement with Novartis Vaccines
and Diagnostics, Inc. for related to TIP was terminated on December 31, 2008. As part of the
termination, we relinquished its rights to future research and development funding and milestone
payments, as well as to any future royalty payments or manufacturing revenue.
Bayer Schering Pharma AG
Cipro Inhale
We were party to a collaborative research, development and commercialization agreement with
Bayer Schering Pharma AG related to the development of an inhaled powder formulation of Cipro
Inhale for the treatment of chronic lung infections caused by Pseudomonas aeruginosa in cystic
fibrosis patients. We were reimbursed for the cost of work performed on a revenue per annual FTE
basis, plus out of pocket third party costs. Revenue recognized approximates the cost associated
with these billable services. We recognized $10.3 million, $7.7 million, and $4.8 million in
reimbursed research and development revenue during the years ended December 31, 2008, 2007, and
2006.
As of December 31, 2008, we assigned the collaborative research, development and
commercialization agreement to Novartis Pharma AG. Pursuant to the terms of the Asset Purchase
Agreement with Novartis, we maintain the right to receive potential royalties in the future based
on net product sales if Cipro Inhale receives regulatory approval and is successfully
commercialized. See Note 11 to Notes to Consolidated Financial Statements for further information
on the pulmonary asset sale to Novartis.
73
Bayer Healthcare LLC
BAY41-6651 (NKTR-061, Amikacin Inhale)
On August 1, 2007, we entered into a co-development, license and co-promotion agreement with
Bayer Healthcare LLC to develop a specially-formulated inhaled Amikacin (BAY41-6651). We are
responsible for any future development of the nebulizer device included in the Amikacin product
through the completion of Phase 3 clinical trials and scale-up for commercialization. Bayer
Healthcare LLC is responsible for most future clinical development and commercialization costs, all
activities to support worldwide regulatory filings, approvals and related activities, further
development of BAY41-6651 and final product packaging. We received an up-front payment of $40.0
million in 2007 and performance milestone payments of $20.0 million, of which we have recognized
$10.1 million and $1.3 million during the years ended December 31, 2008 and 2007, respectively. We
are entitled to development milestones and sales milestones upon achievement of certain annual
sales targets and royalties based on annual worldwide net sales of BAY 41-6651.
Pfizer Inc.
Exubera ® inhalation powder and Next-generation inhaled insulin (NGI)
We were a party to collaboration agreements with Pfizer related to the development of Exubera
and the next-generation inhaled insulin that terminated on November 9, 2007. Under the terms of
the collaboration agreements, we received contract research and development revenue as well as
milestone and up-front fees related to the Exubera bulk powder insulin manufacturing, Exubera
inhaler device manufacturing through our contract manufacturers, and development related to NGI.
We were reimbursed for the cost of work performed on a revenue per annual FTE basis, plus out of
pocket third party costs. Revenue recognized approximates the cost associated with these billable
services. We recognized nil, $18.5 million, and $22.7 million, respectively, in reimbursed
research and development revenue during the years ended December 31, 2008, 2007, and 2006. Please
refer to Note 12 of Notes to Consolidated Financial Statements for further information on the
termination of our collaborative agreements with Pfizer Inc.
Note
11 Novartis Pulmonary Asset Sale
On December 31, 2008, we completed the sale of certain assets related to our pulmonary
business, associated technology and intellectual property to Novartis Pharma AG and Novartis
Pharmaceuticals Corporation (together referred to as Novartis) for a purchase price of $115.0
million in cash (the Novartis Pulmonary Asset Sale). Pursuant to the asset purchase agreement
entered between Novartis and us, we transferred to Novartis certain assets and obligations related
to our pulmonary technology, development and manufacturing operations including:
|
|
|
dry powder and liquid pulmonary technology platform including but not limited to our
pulmonary inhalation devices, formulation technology, manufacturing technology and related
intellectual property; |
|
|
|
manufacturing and associated development services payments for the Cipro Inhale program; |
|
|
|
|
manufacturing and royalty rights to the TIP program; |
|
|
|
|
capital equipment, information systems and facility lease obligations for our pulmonary
development and manufacturing facility in San Carlos, California; |
|
|
|
|
certain other interests that we had in two private companies, Pearl Therapeutics Inc. and
Stamford Devices Limited; and |
|
|
|
|
approximately 140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing operations, whom Novartis hired immediately
following the closing of the transaction. |
We have retained all of our rights to BAY41-6651 partnered with Bayer Healthcare LLC, certain
royalty rights on commercial sales of Cipro Inhale by Bayer Schering Pharma AG, all rights to the
ongoing development program for NKTR-063 and certain intellectual property rights specific to
inhaled insulin.
74
Gain on sale of pulmonary assets
On December 31, 2008, we recognized a Gain on sale of pulmonary assets for certain assets sold
to Novartis, which is comprised of the following (in thousands):
|
|
|
|
|
|
|
Year ended December 31, 2008 |
|
Proceeds from sale of certain pulmonary assets |
|
$ |
115,000 |
|
Transaction costs |
|
|
(4,609 |
) |
Net book value of property and equipment sold |
|
|
(37,291 |
) |
Equity investment in Pearl Therapeutics, net |
|
|
(2,658 |
) |
Goodwill related to pulmonary assets sold |
|
|
(1,930 |
) |
Other, net |
|
|
1,060 |
|
|
|
|
|
Gain on sale of pulmonary assets |
|
$ |
69,572 |
|
|
|
|
|
Additional Costs
In addition to the transaction costs recorded as part of the Gain on sale of pulmonary assets,
we expect to incur approximately $3.7 million to $4.2 million of additional costs in connection
with the Novartis Pulmonary Asset Sale, comprised of $1.9 million of one-time employee termination
costs, $1.0 million to $1.5 million to relocate our IT server room, and $0.8 million in other
costs. Under our Transition Service Agreement with Novartis, we have until December 31, 2009 to
relocate our server room. During 2008, we have recognized approximately $2.7 million of additional
costs incurred in our Statement of operations within Research and development expenses, of which we
paid $1.8 million.
Note 12 Termination of Pfizer Agreements and Inhaled Insulin Program
On November 9, 2007, we entered into a termination agreement and mutual release of our
collaborative development and license agreements agreement with Pfizer and all other related
agreements (Pfizer agreements). Under the termination agreement, we received a one-time payment of
$135.0 million in November 2007 from Pfizer in satisfaction of all outstanding contractual
obligations under our existing agreements relating to Exubera and NGI. Contractual obligations
included unbilled product sales and contract research revenue through November 9, 2007, outstanding
accounts receivable as of November 9, 2007, unrecovered capital costs at November 9, 2007, and
contract termination costs.
On February 12, 2008, we entered into a Termination and 2008 Continuation Agreement (TCA) with
Tech Group pursuant to which the manufacturing and supply agreement for the Exubera inhaler device
(Exubera Inhaler MSA) was terminated in its entirety and we agreed to pay Tech Group $13.8 million
in termination costs and $4.8 million in satisfaction of outstanding accounts payable. As part of
the TCA, we agreed to compensate Tech Group to retain a limited number of core Exubera inhaler
manufacturing personnel and its dedicated Exubera inhaler manufacturing facility for a limited
period in 2008. We also entered into a letter agreement with Pfizer to retain a limited number of
Exubera manufacturing personnel at Pfizers Terre Haute, Indiana manufacturing facility during
March and April 2008.
On February 14, 2008, we entered into a Termination and Mutual Release Agreement with Bespak
pursuant to which the Exubera Inhaler MSA was terminated in its entirety and we agreed to pay
Bespak £11.0 million, or approximately $21.6 million, including $3.0 million in satisfaction of
outstanding accounts payable and $18.6 million in termination costs and expenses that were due and
payable under the termination provisions of the Exubera Inhaler MSA, which included reimbursement
of inventory, inventory purchase commitments, unamortized depreciation on property and equipment,
severance costs and operating lease commitments.
On April 9, 2008, we announced that we had ceased all negotiations with potential partners for
Exubera and NGI as a result of new data analysis from ongoing clinical trials conducted by Pfizer
which indicated an increase in the number of new cases of lung cancer in Exubera patients who were
former smokers as compared to patients in the control group who were former smokers. Following
the termination of our inhaled insulin programs on April 9, 2008, we terminated our continuation
agreements with Tech Group and Pfizer.
75
Gain on Termination of Collaborative Agreements, Net
During the year ended December 31, 2007, we recognized a Gain on termination of collaborative
agreements, net which is comprised of the following (in thousands):
|
|
|
|
|
|
|
Year ended December 31, 2007 |
|
Pfizer termination settlement payment received |
|
$ |
135,000 |
|
Exubera Inhaler Manufacturing and Supply Agreement Termination |
|
|
|
|
Tech Group |
|
|
(13,765 |
) |
Bespak |
|
|
(18,598 |
) |
|
|
|
|
|
|
|
102,637 |
|
Settlement of assets and liabilities related to Pfizer |
|
|
(23,459 |
) |
|
|
|
|
Gain on termination of collaborative agreements, net |
|
$ |
79,178 |
|
|
|
|
|
Idle Exubera Manufacturing Capacity Costs
Idle Exubera manufacturing capacity costs, which is disclosed as a component of Other cost of
revenue, include costs payable to Pfizer and Tech Group under our continuation agreements and
internal salaries, benefits and stock-based compensation related to Exubera commercial
manufacturing employees, overhead at our San Carlos manufacturing facility, including rent,
utilities and maintenance and depreciation of property and equipment. We incurred these costs from
the termination of the Pfizer Agreements on November 9, 2007 through the termination of our inhaled
insulin programs in April 2008. For the years ended December 31, 2008 and 2007, we recognized
Cost of idle Exubera manufacturing capacity of $6.8 million and $6.3 million, respectively.
Accrued Expenses to Contract Manufacturers
As of December 31, 2007, we recorded $40.4 million of accrued expenses to Bespak and Tech
Group for outstanding accounts payable and termination costs and expenses that were due and payable
under the termination provisions of the Exubera Inhaler MSA. This liability was repaid in its
entirety in 2008. As of December 31, 2008, we have no further liabilities related to the Pfizer
Agreements.
Note 13Impairment of Long Lived Assets
During the years ended December 31, 2008, 2007, and 2006, we recorded the following charges in
the Impairment of long lived assets line item of our Consolidated Statements of Operations (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Property and Equipment |
|
|
|
|
|
|
|
|
|
|
|
|
PEGylation manufacturing equipment |
|
$ |
1,458 |
|
|
$ |
|
|
|
$ |
|
|
Exubera-related |
|
|
|
|
|
|
28,396 |
|
|
|
|
|
Bradford, UK |
|
|
|
|
|
|
|
|
|
|
1,156 |
|
Construction in progress |
|
|
|
|
|
|
|
|
|
|
2,757 |
|
Aerogen core-technology intangible assets |
|
|
|
|
|
|
|
|
|
|
5,497 |
|
|
|
|
|
|
|
|
|
|
|
Impairment of long lived assets |
|
$ |
1,458 |
|
|
$ |
28,396 |
|
|
$ |
9,410 |
|
|
|
|
|
|
|
|
|
|
|
76
PEGylation manufacturing equipment
As of December 31, 2008, we determined that a specialized dryer used in our PEGylation
manufacturing facility was not functioning properly and is not being used in operations currently.
We performed an impairment analysis and determined the carrying value exceeded the fair value based
on a discounted cash flow model. As a result, we recorded an impairment loss for the net book
value of the equipment of $1.5 million.
Exubera-related property and equipment
On November 9, 2007, we entered into a termination agreement and mutual release with Pfizer
related to Exubera and NGI. As a result, we performed an impairment analysis of the property and
equipment that support Exubera commercial operations and NGI (Exubera-related assets), including
machinery and equipment at our contract manufacturer locations and machinery, equipment, and
leasehold improvements in San Carlos and determined the fair value based on a discounted cash flow
model. As of December 31, 2007, we concluded that the carrying value exceeded the estimated future
cash flow and recorded an impairment charge of $28.4 million for the Exubera-related assets. See
Note 12 for further discussion of the termination of the inhaled insulin programs.
Bradford UK property and equipment
In June 2006, we involuntarily terminated the majority of the personnel located at our
Bradford, UK site, commenced with plans to wind-down the location and its related operations, and
reassessed the useful life of the remaining laboratory and office equipment. We determined that
these assets could not be redeployed and had no future or alternative use. Due to our revised
estimate of the useful life of these assets, we accelerated approximately $1.2 million of remaining
depreciation in the year ended December 31, 2006.
Construction in progress
In December 2006, we determined that one of our construction-in-progress assets would no
longer be completed based on the contract renegotiation with one of our collaboration partners and
we recorded an impairment loss for the costs incurred to date of $2.8 million.
Aerogen core-technology intangible assets
As part of the October 2005 acquisition of Aerogen, Inc., we also acquired $7.2 million in
core technology intangible assets. In late December 2006, we entered into a non-binding letter of
intent to sell our general purpose nebulizer device business to the former management of Aerogen
Ireland, a wholly-owned subsidiary of Aerogen, Inc. During the year ended December 31, 2006, we
determined that the non-binding letter of intent to sell the general purpose nebulizer device
business, the anticipated proceeds of such potential sale, and the historical losses of the general
purposes nebulizer device business were indicators that this intangible asset did not have future
value and, as a result, we recorded a $5.5 million impairment charge.
Note 14Workforce Reduction Plans
In an effort to reduce ongoing operating costs and improve our organizational structure,
efficiency and productivity, we executed workforce reduction plans in May 2007 (2007 Plan) and
February 2008 (2008 Plan) designed to streamline the company, consolidate corporate functions, and
strengthen decision-making and execution within our business units.
The 2007 Plan reduced our workforce by approximately 180 full-time employees, or approximately
25 percent of our regular full-time employees. The 2008 Plan reduced our workforce by
approximately 110 employees, or approximately 20 percent of our regular full-time employees. The
2007 Plan and the 2008 Plan cost approximately $8.4 million and $5.0 million, respectively,
comprised of cash payments for severance, medical insurance, and outplacement services. Both
plans were substantially complete at December 31, 2008.
For the years ended December 31, 2008 and 2007, workforce reduction charges were recorded in
our Consolidated Financial Statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
Cost of goods sold, net of inventory change |
|
$ |
148 |
|
|
$ |
974 |
|
Other cost of revenue |
|
|
1,221 |
|
|
|
|
|
Research and development expense |
|
|
3,087 |
|
|
|
5,791 |
|
General and administrative expense |
|
|
517 |
|
|
|
1,617 |
|
|
|
|
|
|
|
|
Total workforce reduction charges |
|
$ |
4,973 |
|
|
$ |
8,382 |
|
|
|
|
|
|
|
|
77
The following table summarizes the liabilities associated with the 2007 Plan and the 2008 Plan
included in Accrued compensation in our Consolidated Balance Sheets as of December 31, 2008 and
December 31, 2007, and the activity during the year ended December 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Plan |
|
|
2008 Plan |
|
|
Total |
|
Balance at December 31, 2007 |
|
$ |
580 |
|
|
$ |
|
|
|
$ |
580 |
|
Charges |
|
|
|
|
|
|
4,973 |
|
|
|
4,973 |
|
Payments |
|
|
(580 |
) |
|
|
(4,868 |
) |
|
|
(5,448 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
|
|
|
$ |
105 |
|
|
$ |
105 |
|
|
|
|
|
|
|
|
|
|
|
Note 15Stock-Based Compensation
We issue stock-based awards from three equity incentive plans, which are more fully described
in Note 9 Stockholders Equity. Stock-based compensation cost is recorded in the following line
items of our Consolidated Financial Statements:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Cost of goods sold, net of change in inventory |
|
$ |
269 |
|
|
$ |
1,003 |
|
|
$ |
1,614 |
|
Research and development |
|
|
4,642 |
|
|
|
6,275 |
|
|
|
9,692 |
|
General and administrative |
|
|
4,960 |
|
|
|
5,915 |
|
|
|
17,837 |
|
|
|
|
|
|
|
|
|
|
|
Total compensation cost for share-based arrangements |
|
$ |
9,871 |
|
|
$ |
13,193 |
|
|
$ |
29,143 |
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, 2008, 2007, and 2006, we recorded approximately $2.2 million,
$0.5 million, and $11.8 million, respectively, of stock-based compensation expense related to
modifications of certain stock grants in connection with employment separation agreements.
Generally, the modifications extended the option holders exercise period beyond the 90 day period
after termination and accelerated a portion of the option holders unvested grants. Stock-based
compensation charges are non-cash charges and as such have no impact on our financial position or
reported cash flows.
Aggregate Unrecognized Stock-based Compensation Expense
As of December 31, 2008, total unrecognized compensation expense related to unvested
stock-based compensation arrangements under the Options Plans is expected to be recognized over a
weighted-average period of 1.98 years as follows (in thousands):
|
|
|
|
|
|
|
As of |
|
|
|
December 31, |
|
Fiscal Year |
|
2008 |
|
2009 |
|
$ |
8,080 |
|
2010 |
|
|
6,845 |
|
2011 |
|
|
5,662 |
|
2012 and thereafter |
|
|
966 |
|
|
|
|
|
|
|
$ |
21,553 |
|
|
|
|
|
Black-Scholes Assumptions
The following tables list the Black-Scholes assumptions used to calculate the fair value of
employee stock options and ESPP purchases.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2008 |
|
|
Year ended December 31, 2007 |
|
|
Year ended December 31, 2006 |
|
|
|
Employee |
|
|
|
|
|
|
Employee |
|
|
|
|
|
|
Employee |
|
|
|
|
|
|
Stock Options |
|
|
ESPP |
|
|
Stock Options |
|
|
ESPP |
|
|
Stock Options |
|
|
ESPP |
|
Average risk-free interest rate |
|
|
2.5 |
% |
|
|
2.00 |
% |
|
|
4.2 |
% |
|
|
4.8 |
% |
|
|
4.8 |
% |
|
|
5.2 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility factor |
|
|
51.58 |
% |
|
|
72.34 |
% |
|
|
53.3 |
% |
|
|
38.4 |
% |
|
|
63.1 |
% |
|
|
33.3 |
% |
Weighted average expected life |
|
4.97 years |
|
|
0.5 years |
|
|
5.09 years |
|
|
0.5 years |
|
|
5.20 years |
|
|
0.5 years |
|
78
Generally the stock-based grants have expected terms ranging from 30 months to 61 months. For
the period ended December 31, 2008, the annual forfeiture rate for directors, employee options, and
employee RSU awards was estimated to be 0%, 11%, and 25% respectively. For the twelve months ended
December 31, 2007 and 2006, the annual forfeiture rate for executives and staff was estimated to be
4.7% and 7.4%, respectively, based on our qualitative and quantitative analysis of our historical
forfeitures.
The grant date fair value of RSU awards is always equal to the intrinsic value of the award on
the date of grant since the awards were issued for no consideration. The weighted average life of
the 2008, 2007, and 2006 RSU awards is estimated to be 0.8 years, 1.2 years, and 3.0 years,
respectively.
Summary of Stock Option Activity
The table below presents a summary of stock option activity under the 2000 Equity Incentive
Plan, the Non-Employee Directors Stock Option Plan, and the 2000 Non-Officer Equity Incentive Plan
(in thousands, except for price per share information):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
Options Outstanding |
|
|
Exercise |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise Price |
|
|
Price |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Per Share |
|
|
Per Share |
|
|
Life (in years) |
|
|
Value (1) |
|
Balance at December 31, 2005 |
|
|
13,253 |
|
|
$ |
0.0161.63 |
|
|
$ |
17.85 |
|
|
|
5.38 |
|
|
$ |
37,678 |
|
Options granted |
|
|
1,115 |
|
|
|
14.3621.51 |
|
|
|
17.88 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(2,160 |
) |
|
|
0.0520.41 |
|
|
|
9.51 |
|
|
|
|
|
|
$ |
18,651 |
|
Options forfeited & canceled |
|
|
(1,501 |
) |
|
|
4.6252.16 |
|
|
|
21.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
10,707 |
|
|
$ |
0.0161.63 |
|
|
$ |
18.97 |
|
|
|
4.78 |
|
|
$ |
15,348 |
|
Options granted |
|
|
5,257 |
|
|
|
5.9815.24 |
|
|
|
9.87 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(429 |
) |
|
|
0.0114.25 |
|
|
|
6.80 |
|
|
|
|
|
|
$ |
1,770 |
|
Options forfeited & canceled |
|
|
(3,323 |
) |
|
|
4.5055.19 |
|
|
|
18.47 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
12,212 |
|
|
$ |
0.0161.63 |
|
|
$ |
15.62 |
|
|
|
5.20 |
|
|
$ |
643 |
|
Options granted |
|
|
6,180 |
|
|
|
2.837.13 |
|
|
|
6.02 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(39 |
) |
|
|
0.037.33 |
|
|
|
5.72 |
|
|
|
|
|
|
$ |
42 |
|
Options forfeited & canceled |
|
|
(4,802 |
) |
|
|
0.0161.63 |
|
|
|
12.93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
13,551 |
|
|
$ |
0.0160.88 |
|
|
$ |
12.13 |
|
|
|
4.84 |
|
|
$ |
2,032 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2008 |
|
|
7,144 |
|
|
|
|
|
|
$ |
16.57 |
|
|
|
2.89 |
|
|
$ |
276 |
|
Exercisable at December 31, 2007 |
|
|
7,023 |
|
|
|
|
|
|
$ |
19.15 |
|
|
|
3.64 |
|
|
$ |
584 |
|
Exercisable at December 31, 2006 |
|
|
8,185 |
|
|
|
|
|
|
$ |
19.88 |
|
|
|
4.09 |
|
|
$ |
12,229 |
|
|
|
|
(1) |
|
Aggregate Intrinsic Value represents the difference between the exercise price of the option
and the closing market price of our common stock on the exercise date or December 31, as
applicable. |
The weighted-average grant-date fair value of options granted during the years ended December
31, 2008, 2007, and 2006 was $2.79, $5.11, and $10.54, respectively. The estimated fair value of
options that vested during the years ended December 31, 2008, 2007, and 2006 was $9.8 million, $8.7
million, and $12.0 million, respectively.
The following table provides information regarding our outstanding stock options as of
December 31, 2008 (in thousands except for price per share information and contractual life):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Exercisable |
|
Range of |
|
|
|
|
|
Weighted-Average |
|
|
Weighted-Average |
|
|
|
|
|
|
Weighted-Average |
|
Exercise |
|
|
|
|
|
Exercise Price Per |
|
|
Remaining Contractual |
|
|
|
|
|
|
Exercise Price Per |
|
Prices |
|
Number of Shares |
|
|
Share |
|
|
Life (in years) |
|
|
Number of Shares |
|
|
Share |
|
$0.01 $4.83 |
|
|
1,505 |
|
|
$ |
4.34 |
|
|
|
7.40 |
|
|
|
38 |
|
|
$ |
0.20 |
|
$4.90 $6.46 |
|
|
1,376 |
|
|
$ |
5.99 |
|
|
|
6.24 |
|
|
|
521 |
|
|
$ |
5.97 |
|
$6.50 $6.65 |
|
|
2,590 |
|
|
$ |
6.65 |
|
|
|
5.99 |
|
|
|
499 |
|
|
$ |
6.65 |
|
$6.66 $7.58 |
|
|
1,463 |
|
|
$ |
7.01 |
|
|
|
5.99 |
|
|
|
568 |
|
|
$ |
7.04 |
|
$7.63 $11.86 |
|
|
1,423 |
|
|
$ |
9.86 |
|
|
|
4.64 |
|
|
|
970 |
|
|
$ |
9.88 |
|
$12.30 $14.52 |
|
|
1,626 |
|
|
$ |
13.97 |
|
|
|
3.74 |
|
|
|
1,162 |
|
|
$ |
13.90 |
|
$14.53 $19.29 |
|
|
1,373 |
|
|
$ |
17.55 |
|
|
|
3.47 |
|
|
|
1,216 |
|
|
$ |
17.62 |
|
$19.40 $27.88 |
|
|
1,864 |
|
|
$ |
26.16 |
|
|
|
1.99 |
|
|
|
1,839 |
|
|
$ |
26.24 |
|
$27.96 $60.88 |
|
|
331 |
|
|
$ |
37.91 |
|
|
|
1.12 |
|
|
|
331 |
|
|
$ |
37.91 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,551 |
|
|
$ |
12.13 |
|
|
|
4.84 |
|
|
|
7,144 |
|
|
$ |
16.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79
Summary of RSU Award Activity
During 2008, we issued 47,900 RSU awards, respectively to certain officers on a time-based
vesting schedule. Expense for these awards is recognized ratably over the underlying time-based
vesting period and will settle by delivery of shares of our common stock on or shortly after the
date the awards vest. The RSU awards become fully vested over a period of 12 months. We are
expensing the grant date fair value of the awards ratably over the service period.
During 2007, we issued 344,811 RSU awards, respectively to certain officers and employees on a
time-based vesting schedule. Expense for these awards is recognized ratably over the underlying
time-based vesting period and will settle by delivery of shares of our common stock on or shortly
after the date the awards vest. The RSU awards become fully vested over a period of 12 to 48
months. We are expensing the grant date fair value of the awards ratably over the service period.
During 2006, we issued RSU awards totaling 1,088,300 shares of our common stock to certain
employees and directors. The RSU awards are settled by delivery of shares of our common stock on or
shortly after the date the awards vest. A significant portion of these awards vest based upon
achieving three pre-determined performance milestones which were initially expected to occur over a
period of 40 months. We are expensing the grant date fair value of the awards ratably over the
expected performance period.
One of the three milestones was achieved during the three-month period ended June 30, 2007 and
approximately 174,000 shares were vested and released. During 2007, we determined that the second
milestone would not be met. As a result, we reversed all previously recorded compensation expense
related to this performance milestone, approximately $2.8 million, in the third quarter of 2007.
Based on our current drug candidate development efforts, we currently estimate that the achievement
of the third performance milestone is probable by the third quarter in 2011. If our actual
experience in future periods differs from these current estimates, we may change our determination
of the probability of achieving the performance milestone or the estimate of the period in which
the milestone will be achieved.
A summary of RSU award activity is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Weighted-Average |
|
|
Aggregate |
|
|
|
|
|
|
|
contractual Life |
|
|
Grant-Date |
|
|
Intrinsic |
|
|
|
Units Issued |
|
|
(in years) |
|
|
Fair value(1) |
|
|
Value |
|
Balance at December 31, 2005 |
|
|
284 |
|
|
|
1.14 |
|
|
|
|
|
|
$ |
4,676 |
|
Granted |
|
|
1,088 |
|
|
|
|
|
|
$ |
19.55 |
|
|
|
|
|
Released |
|
|
(178 |
) |
|
|
|
|
|
|
|
|
|
$ |
3,184 |
|
Forfeited & Canceled |
|
|
(110 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
1,084 |
|
|
|
1.52 |
|
|
|
|
|
|
$ |
16,479 |
|
Granted |
|
|
345 |
|
|
|
|
|
|
$ |
11.01 |
|
|
|
|
|
Released |
|
|
(334 |
) |
|
|
|
|
|
|
|
|
|
$ |
3,808 |
|
Forfeited & Canceled |
|
|
(360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
735 |
|
|
|
2.03 |
|
|
|
|
|
|
$ |
4,925 |
|
Granted |
|
|
48 |
|
|
|
|
|
|
$ |
5.26 |
|
|
|
|
|
Released |
|
|
(107 |
) |
|
|
|
|
|
|
|
|
|
$ |
487 |
|
Forfeited & Canceled |
|
|
(411 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
265 |
|
|
|
2.48 |
|
|
|
|
|
|
$ |
1,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Fair value represents the difference between the exercise price of the award and the closing
market price of our common stock on the release date or the year ended December 31, 2008 as
applicable. |
80
Note 16Income Taxes
For financial reporting purposes, Loss before provision for income taxes, includes the
following components (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Domestic |
|
$ |
(69,350 |
) |
|
$ |
(30,143 |
) |
|
$ |
(147,059 |
) |
Foreign |
|
|
34,208 |
|
|
|
(1,309 |
) |
|
|
(6,874 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(35,142 |
) |
|
$ |
(31,452 |
) |
|
$ |
(153,933 |
) |
|
|
|
|
|
|
|
|
|
|
As of December 31, 2008, we had a net operating loss carryforward for federal income tax
purposes of approximately $720.6 million, portions of which will begin to expire in 2009. We had a
total state net operating loss carryforward of approximately $423.1 million, which will begin to
expire in 2010. Due to the discontinuation of our Bradford, UK operations, we no longer have a
foreign net operating loss carryforward available as of December 31, 2008.
Utilization of the federal and state net operating loss and credit carryforwards may be
subject to a substantial annual limitation due to the change in ownership provisions of the
Internal Revenue Code of 1986 and similar state provisions. The annual limitation may result in the
expiration of net operating losses and credits before utilization.
The provision (benefit) for income taxes consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
(970 |
) |
|
$ |
194 |
|
|
$ |
|
|
State |
|
|
(69 |
) |
|
|
782 |
|
|
|
6 |
|
Foreign |
|
|
519 |
|
|
|
333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current |
|
|
(520 |
) |
|
|
1,309 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
|
|
|
|
|
|
|
|
|
|
State |
|
|
|
|
|
|
|
|
|
|
822 |
|
Foreign |
|
|
(286 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Deferred |
|
|
(286 |
) |
|
|
|
|
|
|
822 |
|
|
|
|
|
|
|
|
|
|
|
Provision (Benefit) for income taxes |
|
$ |
(806 |
) |
|
$ |
1,309 |
|
|
$ |
828 |
|
|
|
|
|
|
|
|
|
|
|
81
Income tax provision (benefit) related to continuing operations differs from the amounts
computed by applying the statutory income tax rate of 35% to pretax loss as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
U.S. federal provision (benefit) |
|
|
|
|
|
|
|
|
|
|
|
|
At statutory rate |
|
$ |
(12,300 |
) |
|
$ |
(10,998 |
) |
|
$ |
(52,337 |
) |
State taxes |
|
|
(69 |
) |
|
|
782 |
|
|
|
6 |
|
Change in valuation allowance |
|
|
29,768 |
|
|
|
27,829 |
|
|
|
50,385 |
|
Foreign tax differential |
|
|
(11,754 |
) |
|
|
|
|
|
|
|
|
Foreign subsidiary investment |
|
|
(4,777 |
) |
|
|
|
|
|
|
|
|
Unrecognized tax credits |
|
|
(2,366 |
) |
|
|
(13,109 |
) |
|
|
|
|
Capital lease true-up |
|
|
(1,431 |
) |
|
|
|
|
|
|
|
|
Expiring tax attributes |
|
|
1,508 |
|
|
|
|
|
|
|
|
|
Non-deductible employee compensation |
|
|
14 |
|
|
|
210 |
|
|
|
2,138 |
|
Sale of Irish subsidiary |
|
|
|
|
|
|
(3,604 |
) |
|
|
|
|
Investment impairment and non-deductible amortization |
|
|
|
|
|
|
|
|
|
|
636 |
|
Other |
|
|
601 |
|
|
|
199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(806 |
) |
|
$ |
1,309 |
|
|
$ |
828 |
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the net tax effects of loss and credit carryforwards and
temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. Significant components of our
deferred tax assets for federal and state income taxes are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
289,631 |
|
|
$ |
254,419 |
|
Research and other credits |
|
|
50,350 |
|
|
|
47,274 |
|
Capitalized research expenses |
|
|
4,563 |
|
|
|
6,670 |
|
Deferred revenue |
|
|
28,659 |
|
|
|
11,050 |
|
Depreciation |
|
|
|
|
|
|
7,423 |
|
Reserve and accruals |
|
|
9,629 |
|
|
|
24,495 |
|
Stock based compensation |
|
|
20,315 |
|
|
|
16,375 |
|
Capital loss carryforward |
|
|
|
|
|
|
3,918 |
|
Other |
|
|
5,163 |
|
|
|
6,170 |
|
|
|
|
|
|
|
|
Deferred tax assets before valuation allowance |
|
|
408,310 |
|
|
|
377,794 |
|
Valuation allowance for deferred tax assets |
|
|
(402,907 |
) |
|
|
(375,318 |
) |
|
|
|
|
|
|
|
Total deferred tax assets |
|
$ |
5,403 |
|
|
$ |
2,476 |
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
(1,479 |
) |
|
|
|
|
Acquisition related intangibles |
|
|
(3,352 |
) |
|
|
(2,476 |
) |
Other |
|
|
(286 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
$ |
(5,117 |
) |
|
$ |
(2,476 |
) |
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
286 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Realization of our deferred tax assets is dependent upon future earnings, if any, the timing
and amount of which are uncertain. Because of our lack of U.S. earnings history, the net U.S.
deferred tax assets have been fully offset by a valuation allowance. The valuation allowance
increased by $27.6 million and $52.8 million during the years ended December 31, 2008 and 2007,
respectively. The valuation allowance includes approximately $35.6 million of benefit as of
December 31, 2008 and December 31, 2007 related to stock based compensation and exercises, prior to
the implementation of SFAS No. 123R, that will be credited to additional paid in capital when
realized. We have federal research credits of approximately $20.8 million, which will begin to
expire in 2009 and state research credits of approximately $16.8 million which have no expiration
date. We have federal orphan drug credits of $12.8 million which will expire in 2024.
82
Undistributed earnings of our foreign subsidiary in India are considered to be permanently
reinvested and accordingly, no deferred U.S. income taxes have been provided thereon. Upon
distribution of those earnings in the form of dividends or otherwise, we would be subject to U.S.
income tax.
In July 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes. This interpretation, among other things, creates a two-step approach for evaluating
uncertain tax positions. Recognition occurs when an enterprise concludes that a tax position, based
on its technical merits, is more-likely-than-not to be sustained upon examination. Measurement
determines the amount of benefit that more-likely-than-not will be realized. De-recognition of a
tax position that was previously recognized would occur when a company subsequently determines that
a tax position no longer meets the more-likely-than-not threshold of being sustained. FIN 48
specifically prohibits the use of a valuation allowance as a substitute for de-recognition of tax
positions, and it has expanded disclosure requirements.
As of December 31, 2008 and December 31, 2007, we had $11.7 million and $9.2 million,
respectively, of unrecognized tax benefits. We historically accrued for uncertain tax positions in
deferred tax assets as we have been in a net operating loss position since inception and any
adjustments to our tax positions would result in an adjustment of our net operating loss or tax
credit carry forwards rather than resulting in a cash outlay. If we are eventually able to
recognize these uncertain positions, our effective tax rate would be reduced. We currently have a
full valuation allowance against our net deferred tax asset which would impact the timing of the
effective tax rate benefit should any of these uncertain tax positions be favorably settled in the
future.
It is reasonably possible that certain unrecognized tax benefits may increase or decrease
within the next twelve months due to tax examination changes, settlement activities, expirations of
statute of limitations, or the impact on recognition and measurement considerations related to the
results of published tax cases or other similar activities. We do not anticipate any significant
changes to unrecognized tax benefits over the next 12 months.
Our policy is to include interest and penalties related to unrecognized tax benefits, if any,
within the provision for taxes in the consolidated condensed statements of operations under the
provisions of FIN 48. During the years ended December 31, 2008 and 2007, no interest or penalties
were required to be recognized relating to unrecognized tax benefits.
We file income tax returns in the U.S., as well as California, Alabama, and various foreign
jurisdictions. We are currently not the subject of any income tax examinations. In general, the
earliest open year subject to examination is 2005 for U.S. and Alabama and 2004 for California,
although depending upon jurisdiction, tax years may remain open subject to limitations. We have
evaluated the need for additional tax reserves for any audits as part of our FIN 48 adoption
process.
We have the following activity relating to unrecognized tax benefits (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Beginning balance |
|
$ |
9,222 |
|
|
$ |
7,176 |
|
Tax positions related to current year |
|
|
|
|
|
|
|
|
Additions |
|
|
2,438 |
|
|
|
2,046 |
|
Reductions |
|
|
|
|
|
|
|
|
Tax positions related to prior year |
|
|
|
|
|
|
|
|
Additions |
|
|
|
|
|
|
|
|
Reductions |
|
|
|
|
|
|
|
|
Settlements |
|
|
|
|
|
|
|
|
Lapses in statute of limitations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
11,660 |
|
|
$ |
9,222 |
|
|
|
|
|
|
|
|
83
Note 17Segment Reporting
We operate in one business segment which focuses on applying our technology platforms to
improve the performance of established and novel medicines. We operate in one segment because our
business offerings have similar economics and other characteristics, including the nature of
products and production processes, types of customers, distribution methods and regulatory
environment. We are comprehensively managed as one business segment by our Chief Executive Officer
and his management team. Within our one business segment we have two components, PEGylation
technology and pulmonary technology.
Our revenue is derived primarily from clients in the pharmaceutical and biotechnology
industries. Four of our customers, Bayer (including Bayer Healthcare LLC and Bayer Schering Pharma
AG), UCB Pharma, Novartis, and Roche represented 24%, 16%, 15%, and 14%, respectively, of our total
revenue during the year ended December 31, 2008. Due to the termination of our collaborative
agreements with Pfizer, we did not receive any revenue from Pfizer in 2008 related to Exubera or
NGI. Revenue from Pfizer Inc. represented 69% and 64% of our revenue for the years ended December
31, 2007 and 2006, respectively.
Revenue by geographic area is based on the shipping locations of the customers. The following
table sets forth revenue by geographic area (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
United States |
|
$ |
30,800 |
|
|
$ |
212,990 |
|
|
$ |
182,959 |
|
European countries |
|
|
59,385 |
|
|
|
60,037 |
|
|
|
33,471 |
|
All other countries |
|
|
|
|
|
|
|
|
|
|
1,288 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2008, $69.2 million, or approximately 94%, of the net book value of our
property and equipment was located in the United States and $4.4 million, or approximately 6%, was
located in India. At December 31, 2007, approximately 98% of the net book value of our property
and equipment of $114.4 million was located in the United States.
Note 18Selected Quarterly Financial Data (Unaudited)
The following table sets forth certain unaudited quarterly financial data. In our opinion, the
unaudited information set forth below has been prepared on the same basis as the audited
information and includes all adjustments necessary to present fairly the information set forth
herein. We have experienced fluctuations in our quarterly results. We expect these fluctuations to
continue in the future. Due to these and other factors, we believe that quarter-to-quarter
comparisons of our operating results will not be meaningful, and you should not rely on our results
for one quarter as an indication of our future performance. Certain items previously reported in
specific financial statement captions have been reclassified to conform to the current period
presentation. Such reclassifications have not impacted previously reported revenues, operating loss
or net loss. All data is in thousands except per share information.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year 2008 |
|
|
Fiscal Year 2007 |
|
|
|
Q1 |
|
|
Q2 |
|
|
Q3 |
|
|
Q4 |
|
|
Q1 |
|
|
Q2 |
|
|
Q3 |
|
|
Q4 |
|
Product sales and royalty revenue (1) |
|
$ |
10,371 |
|
|
$ |
9,010 |
|
|
$ |
9,474 |
|
|
$ |
12,400 |
|
|
$ |
71,355 |
|
|
$ |
47,001 |
|
|
$ |
35,697 |
|
|
$ |
26,702 |
|
Collaboration and other revenue |
|
$ |
9,621 |
|
|
$ |
11,392 |
|
|
$ |
11,965 |
|
|
$ |
15,952 |
|
|
$ |
13,661 |
|
|
$ |
18,916 |
|
|
$ |
20,624 |
|
|
$ |
39,071 |
|
Gross margin on product sales |
|
$ |
3,144 |
|
|
$ |
3,566 |
|
|
$ |
4,125 |
|
|
$ |
2,204 |
|
|
$ |
15,727 |
|
|
$ |
8,626 |
|
|
$ |
9,391 |
|
|
$ |
9,315 |
|
Research and development expenses |
|
$ |
37,373 |
|
|
$ |
33,500 |
|
|
$ |
38,265 |
|
|
$ |
45,279 |
|
|
$ |
37,492 |
|
|
$ |
41,000 |
|
|
$ |
35,773 |
|
|
$ |
39,310 |
|
General and administrative expenses (2) |
|
$ |
11,947 |
|
|
$ |
13,329 |
|
|
$ |
12,386 |
|
|
$ |
13,835 |
|
|
$ |
16,971 |
|
|
$ |
13,415 |
|
|
$ |
12,663 |
|
|
$ |
14,233 |
|
Impairment of long lived assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,458 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
28,396 |
|
Gain on sale of pulmonary assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(69,572 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gain on termination of collaborative agreements, net |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(79,178 |
) |
Operating income (loss) |
|
$ |
(41,889 |
) |
|
$ |
(33,358 |
) |
|
$ |
(34,561 |
) |
|
$ |
27,156 |
|
|
$ |
(25,969 |
) |
|
$ |
(27,988 |
) |
|
$ |
(19,572 |
) |
|
$ |
37,381 |
|
Interest expense |
|
$ |
3,918 |
|
|
$ |
3,929 |
|
|
$ |
3,988 |
|
|
$ |
3,357 |
|
|
$ |
4,933 |
|
|
$ |
4,702 |
|
|
$ |
4,773 |
|
|
$ |
4,230 |
|
Gain on extinguishment of debt |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
50,149 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Net income (loss) |
|
$ |
(40,705 |
) |
|
$ |
(33,375 |
) |
|
$ |
(37,038 |
) |
|
$ |
76,782 |
|
|
$ |
(25,673 |
) |
|
$ |
(27,510 |
) |
|
$ |
(18,620 |
) |
|
$ |
39,042 |
|
Basic and diluted net income (loss) per share (3)(4) |
|
$ |
(0.44 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.40 |
) |
|
$ |
0.83 |
|
|
$ |
(0.28 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.20 |
) |
|
$ |
0.42 |
|
|
|
|
(1) |
|
Exubera commercialization readiness revenue was reclassified from Product sales and royalties
to Collaboration and other revenue. |
|
(2) |
|
Amortization of other intangible assets was previously separately disclosed, but has been
combined with General and administrative expenses for the years ended December 31, 2008, 2007,
and 2006. |
|
(3) |
|
Quarterly loss per share amounts may not total the year-to-date loss per share due to
rounding. |
|
(4) |
|
During the fourth quarter of 2008 and 2007, there were approximately 81 dilutive shares and
578 dilutive shares, respectively, outstanding which did not change earnings per share. |
84
SCHEDULE II
NEKTAR THERAPEUTICS
VALUATION AND QUALIFYING ACCOUNTS AND RESERVES
YEARS ENDED DECEMBER 31, 2008, 2007, and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charged to |
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Costs and |
|
|
|
|
|
|
Balance At |
|
|
|
Beginning |
|
|
Expenses, |
|
|
|
|
|
|
End |
|
Description |
|
of Year |
|
|
Net of Reversals |
|
|
Utilizations |
|
|
of Year |
|
|
|
(In thousands) |
|
2008: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
33 |
|
|
$ |
61 |
|
|
$ |
(2 |
) |
|
$ |
92 |
|
Allowance for inventory reserves |
|
$ |
5,772 |
|
|
$ |
2,668 |
|
|
$ |
(3,451 |
) |
|
$ |
4,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
357 |
|
|
$ |
(16 |
) |
|
$ |
(308 |
) |
|
$ |
33 |
|
Allowance for inventory reserves |
|
$ |
4,160 |
|
|
$ |
4,670 |
|
|
$ |
(3,058 |
) |
|
$ |
5,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
70 |
|
|
$ |
380 |
|
|
$ |
(93 |
) |
|
$ |
357 |
|
Allowance for inventory reserves |
|
$ |
3,068 |
|
|
$ |
2,592 |
|
|
$ |
(1,500 |
) |
|
$ |
4,160 |
|
85
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Not applicable.
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Securities Exchange Act reports is recorded, processed, summarized
and reported within the time periods specified in the SECs rules and forms, and that such
information is accumulated and communicated to management, including our Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely decisions regarding required financial
disclosure.
As of the end of the period covered by this report, we carried out an evaluation, under the
supervision and with the participation of our management, including the Chief Executive Officer and
the Chief Financial Officer, of the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Exchange Act Rule 13a-15. Based upon, and as of the date of,
this evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that our
disclosure controls and procedures were effective. Accordingly, management believes that the
financial statements included in this report fairly present in all material respects our financial
condition, results of operations and cashflows for the periods presented.
Managements Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over
financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Our internal control
over financial reporting is a process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with GAAP.
Our management has assessed the effectiveness of our internal control over financial reporting
as of December 31, 2008. In making its assessment of internal control over financial reporting,
management used the criteria described in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission.
Based on our evaluation under the framework described in Internal ControlIntegrated
Framework, our management concluded that our internal control over financial reporting was
effective as of December 31, 2008.
The effectiveness of our internal control over financial reporting as of December 31, 2008 has
been audited by an independent registered public accounting firm, as stated in their report, which
is included herein.
Changes in Internal Control Over Financial Reporting
We continuously seek to improve the efficiency and effectiveness of our internal controls.
This results in refinements to processes throughout the Company. In October 2008, we completed the
implementation of an upgraded enterprise resource planning (ERP) system designed and implemented to
make our financial reporting more efficient and integrated across our enterprise. The
implementation of the ERP system did not result in changes to our controls over financial
reporting. As a result, there was no change in our internal control over financial reporting
during the quarter ended December 31, 2008, which was identified in connection with our
managements evaluation required by Exchange Act Rules 13a-15(f) and 15d-15(f) that has materially
affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
Inherent Limitations on the Effectiveness of Controls
Our management, including the Chief Executive Officer and Chief Financial Officer, does not
expect that our disclosure controls and procedures or our internal control over financial reporting
will prevent all error and all fraud. A control system, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the control system are
met. Because of the inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if any, within the
company have been detected. These inherent limitations include the realities that judgments in
decision making can be faulty and that breakdowns can occur because of simple error or mistake.
Additionally, controls can be circumvented by the individual acts of some persons, by collusion of
two or more people or by management override of the control. The design of any system of controls
also is based in part upon certain assumptions about the likelihood of future events, and there can
be no assurance that any design will succeed in achieving its stated goals under all potential
future conditions. Over time, controls may become inadequate because of changes in conditions, or
the degree of compliance with the policies or procedures may deteriorate. Because of the inherent
limitations in a cost-effective control system, misstatements due to error or fraud may occur and
not be detected.
Item 9B. Other Information
None.
86
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Information relating to our executive officers required by this item is set forth in Part
IItem 1 of this report under the caption Executive Officers of the Registrant and is
incorporated herein by reference. The other information required by this Item is incorporated by
reference from the definitive proxy statement for our 2009 Annual Meeting of Stockholders to be
filed with the SEC pursuant to Regulation 14A (Proxy Statement) not later than 120 days after the
end of the fiscal year covered by this Form 10-K under the captions Corporate Governance and Board
of Directors, Proposal 1Election of Directors and Section 16(a) Beneficial Ownership
Reporting Compliance.
Information regarding our audit committee financial expert will be set forth in the Proxy
Statement under the caption Audit Committee, which information is incorporated herein by
reference.
In December 2003, we adopted a Code of Business Conduct and Ethics applicable to all
employees, including the principal executive officer, principal financial officer and principal
accounting officer or controller, or persons performing similar functions. The Code of Business
Conduct and Ethics is posted on our website at www.nektar.com. Amendments to, and waivers from, the
Code of Business Conduct and Ethics that apply to any of these officers, or persons performing
similar functions, and that relate to any element of the code of ethics definition enumerated in
Item 406(b) of Regulation S-K will be disclosed at the website address provided above and, to the
extent required by applicable regulations, on a current report on Form 8-K.
As permitted by SEC Rule 10b5-1, certain of our executive officers, directors and other
employees have set up a predefined, structured stock trading program with their broker to sell our
stock. The stock trading program allows a broker acting on behalf of the executive officer,
director or other employee to trade our stock during blackout periods or while such executive
officer, director or other employee may be aware of material, nonpublic information, if the trade
is performed according to a pre-existing contract, instruction or plan that was established with
the broker during a non-blackout period and when such executive officer, director or employee was
not aware of any material, nonpublic information. Our executive officers, directors and other
employees may also trade our stock outside of the stock trading programs set up under Rule 10b5-1
subject to our blackout periods and insider trading rules.
Item 11. Executive Compensation
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
Item 13. Certain Relationships and Related Transactions and Director Independence
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
Item 14. Principal Accountant Fees and Services
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
87
PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) The following documents are filed as part of this report:
(1) Consolidated Financial Statements:
The following financial statements are filed as part of this report under Item 8 Financial
Statements and Supplementary Data.
|
|
|
|
|
|
|
Page |
|
Reports of Independent Registered Public Accounting Firm |
|
|
53 |
|
Consolidated Balance Sheets at December 31, 2008 and 2007 |
|
|
55 |
|
Consolidated Statements of Operations for each of the three years in the period ended December 31, 2008 |
|
|
56 |
|
Consolidated Statements of Stockholders Equity for each of the three years in the period ended December 31, 2008 |
|
|
57 |
|
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2008 |
|
|
58 |
|
Notes to Consolidated Financial Statements |
|
|
59 |
|
(2) Financial Statement Schedules:
Schedule II, Valuation and Qualifying Accounts and Reserves, is filed as part of this Annual
Report on Form 10-K. All other financial statement schedules have been omitted because they are not
applicable, or the information required is presented in our consolidated financial statements and
notes thereto under Item 8 of this Annual Report on Form 10-K.
(3) Exhibits.
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Annual Report on Form 10-K.
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
2.1 |
|
|
|
(23 |
) |
|
Asset Purchase Agreement, dated October 20, 2008, by and between Nektar Therapeutics, a Delaware
corporation, AeroGen, Inc., a Delaware corporation and wholly-owned subsidiary of Nektar Therapeutics,
Novartis Pharmaceuticals Corporation, a Delaware corporation, and Novartis Pharma AG, a Swiss
corporation+ |
|
|
|
|
|
|
|
|
|
|
3.1 |
|
|
|
(1 |
) |
|
Certificate of Incorporation of Inhale Therapeutic Systems (Delaware), Inc. |
|
|
|
|
|
|
|
|
|
|
3.2 |
|
|
|
(2 |
) |
|
Certificate of Amendment of the Amended Certificate of Incorporation of Inhale Therapeutic Systems, Inc. |
|
|
|
|
|
|
|
|
|
|
3.3 |
|
|
|
(3 |
) |
|
Certificate of Designation of Series A Junior Participating Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.4 |
|
|
|
(4 |
) |
|
Certificate of Designation of Series B Convertible Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.5 |
|
|
|
(5 |
) |
|
Certificate of Ownership and Merger of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.6 |
|
|
|
(6 |
) |
|
Amended and Restated Bylaws of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
4.1 |
|
|
|
|
|
|
Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6 |
|
|
|
|
|
|
|
|
|
|
4.2 |
|
|
|
(5 |
) |
|
Specimen Common Stock certificate |
|
|
|
|
|
|
|
|
|
|
4.3 |
|
|
|
(3 |
) |
|
Rights Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics and Mellon Investor
Services LLC, as Rights Agent |
|
|
|
|
|
|
|
|
|
|
4.4 |
|
|
|
(3 |
) |
|
Form of Right Certificate |
|
|
|
|
|
|
|
|
|
|
4.5 |
|
|
|
(7 |
) |
|
Indenture, dated September 28, 2005, by and between Nektar Therapeutics, as Issuer, and J.P. Morgan
Trust Company, National Association, as Trustee |
|
|
|
|
|
|
|
|
|
|
4.6 |
|
|
|
(7 |
) |
|
Registration Right Agreement, dated as of September 28, 2005, among Nektar Therapeutics and entities
named therein |
88
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
10.1 |
|
|
|
(8 |
) |
|
1994 Non-Employee Directors Stock Option Plan, as amended++ |
|
|
|
|
|
|
|
|
|
|
10.2 |
|
|
|
(9 |
) |
|
1994 Employee Stock Purchase Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.3 |
|
|
|
(10 |
) |
|
2000 Non-Officer Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.4 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive Plan Stock Option
Agreement (Nonstatutory Stock Option)++ |
|
|
|
|
|
|
|
|
|
|
10.5 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory (Unapproved) Stock
Option)++ |
|
|
|
|
|
|
|
|
|
|
10.6 |
|
|
|
(12 |
) |
|
Forms of 2000 Non-Officer Equity Incentive Plan Restricted Stock Unit Grant Notice and Restricted Stock
Unit Agreement++ |
|
|
|
|
|
|
|
|
|
|
10.7 |
|
|
|
(13 |
) |
|
2000 Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.8 |
|
|
|
(14 |
) |
|
Form of Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.9 |
|
|
|
(12 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2000 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.10 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.11 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Restricted Stock Unit Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.12 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on September 4, 2007, with
Louis Drapeau++ |
|
|
|
|
|
|
|
|
|
|
10.13 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on October 5, 2007, with
David Johnston++ |
|
|
|
|
|
|
|
|
|
|
10.14 |
|
|
|
(22 |
) |
|
Compensation Plan for Non-Employee Directors, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.15 |
|
|
|
(10 |
) |
|
401(k) Retirement Plan++ |
|
|
|
|
|
|
|
|
|
|
10.16 |
|
|
|
(22 |
) |
|
2008 Discretionary Performance-Based Incentive Compensation Policy++ |
|
|
|
|
|
|
|
|
|
|
10.17 |
|
|
|
(23 |
) |
|
Amended and Restated Change of Control Severance Benefit Plan++ |
|
|
|
|
|
|
|
|
|
|
10.18 |
|
|
|
(17 |
) |
|
Transition and Retirement Agreement, dated March 13, 2006, with Ajit S. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.19 |
|
|
|
(18 |
) |
|
Letter Amendment, dated October 5, 2006, with Ajit S. Gill, amending that certain Transition and
Retirement Agreement, dated March 13, 2006, with Mr. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.20 |
|
|
|
(23 |
) |
|
2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.21 |
|
|
|
(23 |
) |
|
Forms
of Stock Option Grant Notice and of Stock Option Agreement under the 2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.22 |
|
|
|
(23 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2008 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.23 |
|
|
|
(19 |
) |
|
Separation and General Release Agreement, dated November 17, 2008, with John S. Patton++ |
|
|
|
|
|
|
|
|
|
|
10.24 |
|
|
|
(20 |
) |
|
Bonus and General Release Agreement, dated December 27, 2008, with Nevan C. Elam++ |
|
|
|
|
|
|
|
|
|
|
10.25 |
|
|
|
(15 |
) |
|
Form of Severance Letter for executive officers of the company++ |
|
|
|
|
|
|
|
|
|
|
10.26 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Howard W. Robin++ |
|
|
|
|
|
|
|
|
|
|
10.27 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with John Nicholson++ |
|
|
|
|
|
|
|
|
|
|
10.28 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Bharatt M.
Chowrira, Ph.D., J.D.++ |
89
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
10.29 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Dr. Randall
Moreadith++ |
|
|
|
|
|
|
|
|
|
|
10.30 |
|
|
|
(15 |
) |
|
Amended and Restated Built-to-Suite Lease between Nektar Therapeutics and BMR-201 Industrial Road LLC,
dated August 17, 2004, as amended on January 11, 2005 and July 19, 2007 |
|
|
|
|
|
|
|
|
|
|
10.31 |
|
|
|
(21 |
) |
|
Settlement Agreement and General Release, dated June 30, 2006, by and between The Board of Trustees of
the University of Alabama, The University of Alabama in Huntsville, Nektar Therapeutics AL Corporation
(a wholly-owned subsidiary of Nektar Therapeutics), Nektar Therapeutics and J. Milton Harris |
|
|
|
|
|
|
|
|
|
|
10.32 |
|
|
|
(15 |
) |
|
Co-Development, License and Co-Promotion Agreement, dated August 1, 2007, between Nektar Therapeutics
(and its subsidiaries) and Bayer Healthcare LLC+ |
|
|
|
|
|
|
|
|
|
|
10.33 |
|
|
|
(16 |
) |
|
Termination Agreement and Mutual Release, dated November 9, 2007, between Nektar Therapeutics and
Pfizer Inc.+ |
|
|
|
|
|
|
|
|
|
|
10.34 |
|
|
|
(23 |
) |
|
Exclusive Research, Development, License and Manufacturing and Supply Agreement, by and among Nektar AL
Corporation, Baxter Healthcare SA, and Baxter Healthcare Corporation, dated September 26, 2005, as
amended+ |
|
|
|
|
|
|
|
|
|
|
10.35 |
|
|
|
(23 |
) |
|
Exclusive License Agreement, dated December 31, 2008, between Nektar Therapeutics, a Delaware
corporation, and Novartis Pharma AG, a Swiss corporation+ |
|
|
|
|
|
|
|
|
|
|
21.1 |
|
|
|
(23 |
) |
|
Subsidiaries of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
23.1 |
|
|
|
(23 |
) |
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
Power of Attorney (reference is made to the signature page) |
|
|
|
|
|
|
|
|
|
|
31.1 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
31.2 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
32.1 |
* |
|
|
(23 |
) |
|
Section 1350 Certifications |
|
|
|
+ |
|
Confidential treatment with respect to specific portions of this
Exhibit has been requested, and such portions are omitted and have
been filed separately with the SEC. |
|
++ |
|
Management contract or compensatory plan or arrangement. |
|
* |
|
Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
|
(1) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1998. |
|
(2) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2000. |
|
(3) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 4, 2001. |
|
(4) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 8, 2002. |
|
(5) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 23, 2003. |
|
(6) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on December 12, 2007. |
|
(7) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on September 28, 2005. |
90
|
|
|
(8) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1996. |
|
(9) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-98321), filed on August 19, 2002. |
|
(10) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2004. |
|
(11) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended. |
|
(12) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on
Form 10-K, as amended, for the year ended December 31, 2005. |
|
(13) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 7, 2006. |
|
(14) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2000. |
|
(15) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2007. |
|
(16) |
|
Incorporated by reference to the indicated exhibit in Nektar
Therapeutics Annual Report on
Form 10-K for the year ended December 31, 2007. |
|
(17) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K/A, filed on March 16, 2006. |
|
(18) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006. |
|
(19) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on November 21, 2008. |
|
(20) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 2, 2009. |
|
(21) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2006. |
|
(22) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended March 31, 2008. |
|
(23) |
|
Filed herewith. |
91
SIGNATURES
Pursuant to the Securities Exchange Act of 1934, the Registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Carlos,
County of San Mateo, State of California on March 6, 2009.
|
|
|
|
|
|
By: |
/s/ John Nicholson
|
|
|
|
John Nicholson |
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
|
|
|
By: |
/s/ Jillian B. Thomsen
|
|
|
|
Jillian B. Thomsen |
|
|
|
Vice President and Chief Accounting Officer |
|
92
POWER OF ATTORNEY
KNOW ALL PERSON BY THESE PRESENTS, that each person whose signature appears below constitutes
and appoints John Nicholson and Jillian B. Thomsen and each of them, as his or her true and lawful
attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her
and in his or her name, place and stead, in any and all capacities, to sign any and all amendments
to this Annual Report on Form 10-K and to file the same, with all exhibits thereto and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents and each of them, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in connection therewith, as fully to all
intents and purposes as he or she might or could do in person, hereby ratify and confirming all that said
attorneys-in-fact and agents, or any of them, or their or his or her substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this
report has been signed by the following persons in the capacities and on the dates indicated:
|
|
|
|
|
SIGNATURE |
|
TITLE |
|
DATE |
|
|
|
|
|
/s/ Howard W. Robin
Howard W. Robin
|
|
Chief Executive Officer, President and Director (Principal
Executive Officer)
|
|
March 6, 2009 |
|
|
|
|
|
/s/ John Nicholson
John Nicholson
|
|
Senior Vice President and Chief Financial Officer (Principal
Financial Officer)
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Jillian B, Thomsen
Jillian B. Thomsen
|
|
Vice President Finance and Chief Accounting Officer (Principal
Accounting Officer)
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Robert B. Chess
Robert B. Chess
|
|
Director, Chairman of the Board of Directors
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Michael A. Brown
Michael A. Brown
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Hoyoung Huh
Hoyoung Huh
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Joseph J. Krivulka
Joseph J. Krivulka
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Christopher A. Kuebler
Christopher A. Kuebler
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Lutz Lingnau
Lutz Lingnau
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Susan Wang
Susan Wang
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Roy A. Whitfield
Roy A. Whitfield
|
|
Director
|
|
March 6, 2009 |
93
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Annual Report on Form 10-K.
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
2.1 |
|
|
|
(23 |
) |
|
Asset Purchase Agreement, dated October 20, 2008, by and between Nektar Therapeutics, a Delaware
corporation, AeroGen, Inc., a Delaware corporation and wholly-owned subsidiary of Nektar Therapeutics,
Novartis Pharmaceuticals Corporation, a Delaware corporation, and Novartis Pharma AG, a Swiss
corporation+ |
|
|
|
|
|
|
|
|
|
|
3.1 |
|
|
|
(1 |
) |
|
Certificate of Incorporation of Inhale Therapeutic Systems (Delaware), Inc. |
|
|
|
|
|
|
|
|
|
|
3.2 |
|
|
|
(2 |
) |
|
Certificate of Amendment of the Amended Certificate of Incorporation of Inhale Therapeutic Systems, Inc. |
|
|
|
|
|
|
|
|
|
|
3.3 |
|
|
|
(3 |
) |
|
Certificate of Designation of Series A Junior Participating Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.4 |
|
|
|
(4 |
) |
|
Certificate of Designation of Series B Convertible Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.5 |
|
|
|
(5 |
) |
|
Certificate of Ownership and Merger of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.6 |
|
|
|
(6 |
) |
|
Amended and Restated Bylaws of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
4.1 |
|
|
|
|
|
|
Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6 |
|
|
|
|
|
|
|
|
|
|
4.2 |
|
|
|
(5 |
) |
|
Specimen Common Stock certificate |
|
|
|
|
|
|
|
|
|
|
4.3 |
|
|
|
(3 |
) |
|
Rights Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics and Mellon Investor
Services LLC, as Rights Agent |
|
|
|
|
|
|
|
|
|
|
4.4 |
|
|
|
(3 |
) |
|
Form of Right Certificate |
|
|
|
|
|
|
|
|
|
|
4.5 |
|
|
|
(7 |
) |
|
Indenture, dated September 28, 2005, by and between Nektar Therapeutics, as Issuer, and J.P. Morgan
Trust Company, National Association, as Trustee |
|
|
|
|
|
|
|
|
|
|
4.6 |
|
|
|
(7 |
) |
|
Registration Right Agreement, dated as of September 28, 2005, among Nektar Therapeutics and entities
named therein |
|
|
|
|
|
|
|
|
|
|
10.1 |
|
|
|
(8 |
) |
|
1994 Non-Employee Directors Stock Option Plan, as amended++ |
|
|
|
|
|
|
|
|
|
|
10.2 |
|
|
|
(9 |
) |
|
1994 Employee Stock Purchase Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.3 |
|
|
|
(10 |
) |
|
2000 Non-Officer Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.4 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive
Plan Stock Option Agreement (Nonstatutory Stock Option)++ |
|
|
|
|
|
|
|
|
|
|
10.5 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory (Unapproved) Stock
Option)++ |
|
|
|
|
|
|
|
|
|
|
10.6 |
|
|
|
(12 |
) |
|
Forms of 2000 Non-Officer Equity Incentive Plan Restricted Stock Unit Grant Notice and Restricted Stock
Unit Agreement++ |
|
|
|
|
|
|
|
|
|
|
10.7 |
|
|
|
(13 |
) |
|
2000 Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.8 |
|
|
|
(14 |
) |
|
Form of Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.9 |
|
|
|
(12 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2000 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.10 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.11 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Restricted Stock Unit Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.12 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on September 4, 2007, with
Louis Drapeau++ |
|
|
|
|
|
|
|
|
|
|
10.13 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on October 5, 2007, with
David Johnston++ |
|
|
|
|
|
|
|
|
|
94
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
10.14 |
|
|
|
(22 |
) |
|
Compensation Plan for Non-Employee Directors, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.15 |
|
|
|
(10 |
) |
|
401(k) Retirement Plan++ |
|
|
|
|
|
|
|
|
|
|
10.16 |
|
|
|
(22 |
) |
|
2008 Discretionary Performance-Based Incentive Compensation Policy++ |
|
|
|
|
|
|
|
|
|
|
10.17 |
|
|
|
(23 |
) |
|
Amended and Restated Change of Control Severance Benefit Plan++ |
|
|
|
|
|
|
|
|
|
|
10.18 |
|
|
|
(17 |
) |
|
Transition and Retirement Agreement,
dated March 13, 2006, with Ajit S. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.19 |
|
|
|
(18 |
) |
|
Letter Amendment, dated October 5, 2006, with Ajit S. Gill, amending that certain Transition and Retirement Agreement, dated March 13, 2006, with Mr. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.20 |
|
|
|
(23 |
) |
|
2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.21 |
|
|
|
(23 |
) |
|
Form of Stock Option Agreement under the 2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.22 |
|
|
|
(23 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2008 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.23 |
|
|
|
(19 |
) |
|
Separation and General Release Agreement, dated November 17, 2008, with John S. Patton++ |
|
|
|
|
|
|
|
|
|
|
10.24 |
|
|
|
(20 |
) |
|
Bonus and General Release Agreement, dated December 27, 2008, with Nevan C. Elam++ |
|
|
|
|
|
|
|
|
|
|
10.25 |
|
|
|
(15 |
) |
|
Form of Severance Letter for executive officers of the company++ |
|
|
|
|
|
|
|
|
|
|
10.26 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Howard W. Robin++ |
|
|
|
|
|
|
|
|
|
|
10.27 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with John Nicholson++ |
|
|
|
|
|
|
|
|
|
|
10.28 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Bharatt M.
Chowrira, Ph.D., J.D.++ |
|
|
|
|
|
|
|
|
|
|
10.29 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Dr. Randall
Moreadith++ |
|
|
|
|
|
|
|
|
|
|
10.30 |
|
|
|
(15 |
) |
|
Amended and Restated Built-to-Suite Lease between Nektar Therapeutics and BMR-201 Industrial Road LLC,
dated August 17, 2004, as amended on January 11, 2005 and July 19, 2007 |
|
|
|
|
|
|
|
|
|
|
10.31 |
|
|
|
(21 |
) |
|
Settlement Agreement and General Release, dated June 30, 2006, by and between The Board of Trustees of
the University of Alabama, The University of Alabama in Huntsville, Nektar Therapeutics AL Corporation
(a wholly-owned subsidiary of Nektar Therapeutics), Nektar Therapeutics and J. Milton Harris |
|
|
|
|
|
|
|
|
|
|
10.32 |
|
|
|
(15 |
) |
|
Co-Development, License and Co-Promotion Agreement, dated August 1, 2007, between Nektar Therapeutics
(and its subsidiaries) and Bayer Healthcare LLC+ |
|
|
|
|
|
|
|
|
|
|
10.33 |
|
|
|
(16 |
) |
|
Termination Agreement and Mutual Release, dated November 9, 2007, between Nektar Therapeutics and
Pfizer Inc.+ |
|
|
|
|
|
|
|
|
|
|
10.34 |
|
|
|
(23 |
) |
|
Exclusive Research, Development, License and Manufacturing and Supply Agreement, by and among Nektar AL
Corporation, Baxter Healthcare SA, and Baxter Healthcare Corporation, dated September 26, 2005, as
amended+ |
|
|
|
|
|
|
|
|
|
|
10.35 |
|
|
|
(23 |
) |
|
Exclusive License Agreement, dated December 31, 2008, between Nektar Therapeutics, a Delaware
corporation, and Novartis Pharma AG, a Swiss corporation+ |
|
|
|
|
|
|
|
|
|
|
21.1 |
|
|
|
(23 |
) |
|
Subsidiaries of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
23.1 |
|
|
|
(23 |
) |
|
Consent of Independent Registered Public Accounting Firm |
95
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
Power of Attorney (reference is made to the signature page) |
|
|
|
|
|
|
|
|
|
|
31.1 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
31.2 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
32.1 |
* |
|
|
(23 |
) |
|
Section 1350 Certifications |
|
|
|
+ |
|
Confidential treatment with respect to specific portions of this
Exhibit has been requested, and such portions are omitted and have
been filed separately with the SEC.
|
|
++ |
|
Management contract or compensatory plan or arrangement. |
|
* |
|
Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
|
(1) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1998. |
|
(2) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2000. |
|
(3) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 4, 2001. |
|
(4) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 8, 2002. |
|
(5) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 23, 2003. |
|
(6) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on December 12, 2007. |
|
(7) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on September 28, 2005. |
|
(8) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1996. |
|
(9) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-98321), filed on August 19, 2002. |
|
(10) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2004. |
|
(11) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended. |
|
(12) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on
Form 10-K, as amended, for the year ended December 31, 2005. |
|
(13) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 7, 2006. |
|
(14) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2000. |
|
(15) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2007. |
|
(16) |
|
Incorporated by reference to the indicated exhibit in
Nektar Therapeutics Annual Report on Form 10-K for the year ended December 31, 2007. |
|
(17) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K/A, filed on March 16, 2006. |
|
(18) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006. |
|
(19) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on November 21, 2008. |
|
(20) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 2, 2009. |
|
(21) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2006. |
|
(22) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended March 31, 2008. |
|
(23) |
|
Filed herewith. |
96