20150630 Q2

Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2015

Or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from             to             

Commission File Number 001-34899

 

Pacific Biosciences of California, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

Delaware

16-1590339

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

1380 Willow Road

Menlo Park, CA 94025

94025

(Address of principal executive offices)

(Zip Code)

(650) 521-8000

(Registrant’s telephone number, including area code)

 

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    No  

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes      No  

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

Accelerated filer   

 

 

 

 

Non-accelerated filer

(Do not check if a smaller reporting company)

Smaller reporting company

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

 

Number of shares outstanding of the issuer’s common stock as of July 31, 2015:  74,968,648

  


 

Table of Contents

 

TABLE OF CONTENTS

 

 

 

 

 

PAGE No.

 

 

PART I. FINANCIAL INFORMATION

 

 

 

Item 1. Financial Statements (unaudited): 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2015 and December 31, 2014 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three- and Six-Month Periods Ended June 30, 2015 and 2014 

 

 

Condensed Consolidated Statements of Cash Flows for the Six-Month Periods Ended June 30, 2015 and  2014 

 

 

Notes to Condensed Consolidated Financial Statements 

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 

13 

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk 

21 

 

 

Item 4. Controls and Procedures 

21 

 

 

PART II. OTHER INFORMATION

 

 

 

Item 1. Legal Proceedings 

22 

 

 

Item 1A. Risk Factors 

22 

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 

35 

 

 

Item 3. Default Upon Senior Securities 

35 

 

 

Item 4. Mine Safety Disclosures 

35 

 

 

Item 5. Other Information 

35 

 

 

Item 6. Exhibits 

35 

 

 

 

 

EXHIBIT INDEX 

37 

 

 

 

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PART I. FINANCIAL INFORMATION

Item 1.Financial Statements

PACIFIC BIOSCIENCES OF CALIFORNIA, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

(in thousands except par value amounts)

2015

 

2014

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

$

25,930 

 

$

36,449 

Investments

 

46,744 

 

 

64,899 

Accounts receivable

 

3,950 

 

 

3,406 

Inventory

 

11,978 

 

 

11,335 

Prepaid expenses and other current assets

 

1,587 

 

 

1,671 

Total current assets

 

90,189 

 

 

117,760 

Property and equipment, net

 

6,428 

 

 

6,601 

Other long-term assets

 

153 

 

 

162 

Total assets

$

96,770 

 

$

124,523 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

$

5,818 

 

$

5,608 

Accrued expenses

 

11,316 

 

 

11,441 

Deferred service revenue, current

 

6,507 

 

 

6,121 

Deferred contractual revenue, current

 

14,385 

 

 

6,785 

Other liabilities, current

 

991 

 

 

1,534 

Total current liabilities

 

39,017 

 

 

31,489 

Deferred service revenue, non-current

 

1,316 

 

 

1,129 

Deferred contractual revenue, non-current

 

4,943 

 

 

19,735 

Other liabilities, non-current

 

2,192 

 

 

2,153 

Notes payable

 

14,567 

 

 

14,124 

Financing derivative

 

899 

 

 

944 

Total liabilities

 

62,934 

 

 

69,574 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Preferred Stock, $0.001 par value:

 

 

 

 

 

Authorized 50,000 shares; No shares issued or outstanding 

 

 —

 

 

 —

Common Stock, $0.001 par value:

 

 

 

 

 

Authorized 1,000,000 shares; Issued and outstanding 74,943 shares at June 30, 2015 and 73,927 shares at December 31, 2014 

 

75 

 

 

74 

Additional paid-in capital

 

747,330 

 

 

736,339 

Accumulated other comprehensive income

 

12 

 

 

Accumulated deficit

 

(713,581)

 

 

(681,473)

Total stockholders’ equity

 

33,836 

 

 

54,949 

Total liabilities and stockholders’ equity

$

96,770 

 

$

124,523 

See accompanying notes to the condensed consolidated financial statements.

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PACIFIC BIOSCIENCES OF CALIFORNIA, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three-Month Periods Ended June 30,

 

Six-Month Periods Ended June 30,

 

 

 

(in thousands, except per share amounts)

 

2015

 

2014

 

2015

 

2014

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

8,825 

 

$

7,749 

 

$

20,133 

 

$

15,614 

 

 

 

Service and other revenue

 

 

2,518 

 

 

1,980 

 

 

5,259 

 

 

4,061 

 

 

 

Contractual revenue

 

 

13,596 

 

 

1,696 

 

 

17,192 

 

 

3,392 

 

 

 

Total revenue

 

 

24,939 

 

 

11,425 

 

 

42,584 

 

 

23,067 

 

 

 

Cost of Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

 

8,438 

 

 

6,271 

 

 

18,170 

 

 

13,440 

 

 

 

Cost of service and other revenue

 

 

1,995 

 

 

2,028 

 

 

3,981 

 

 

3,825 

 

 

 

Total cost of revenue

 

 

10,433 

 

 

8,299 

 

 

22,151 

 

 

17,265 

 

 

 

Gross profit

 

 

14,506 

 

 

3,126 

 

 

20,433 

 

 

5,802 

 

 

 

Operating Expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

15,043 

 

 

12,435 

 

 

29,526 

 

 

24,206 

 

 

 

Sales, general and administrative

 

 

10,821 

 

 

8,993 

 

 

21,593 

 

 

18,143 

 

 

 

Total operating expense

 

 

25,864 

 

 

21,428 

 

 

51,119 

 

 

42,349 

 

 

 

Operating loss

 

 

(11,358)

 

 

(18,302)

 

 

(30,686)

 

 

(36,547)

 

 

 

Interest expense

 

 

(715)

 

 

(701)

 

 

(1,412)

 

 

(1,387)

 

 

 

Other income (expense), net

 

 

138 

 

 

(133)

 

 

(10)

 

 

(88)

 

 

 

Net loss

 

 

(11,935)

 

 

(19,136)

 

 

(32,108)

 

 

(38,022)

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on investments

 

 

(4)

 

 

24 

 

 

 

 

28 

 

 

 

Comprehensive loss

 

$

(11,939)

 

$

(19,112)

 

$

(32,105)

 

$

(37,994)

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.16)

 

$

(0.27)

 

$

(0.43)

 

$

(0.55)

 

 

 

Shares used in computing basic and diluted net loss per share

 

 

74,733 

 

 

70,515 

 

 

74,442 

 

 

69,195 

 

 

 

 

See accompanying notes to the condensed consolidated financial statements.

 

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PACIFIC BIOSCIENCES OF CALIFORNIA, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six-Month Periods Ended June 30,

(in thousands)

2015

 

2014

Cash flows from operating activities

 

 

 

 

 

Net loss

$

(32,108)

 

$

(38,022)

Adjustments to reconcile net loss to net cash used in operating activities

 

 

 

 

 

Depreciation

 

1,846 

 

 

2,311 

Amortization of debt discount and financing costs

 

453 

 

 

375 

Stock-based compensation

 

6,575 

 

 

4,492 

Other items

 

(22)

 

 

197 

Changes in assets and liabilities

 

 

 

 

 

Accounts receivable

 

(544)

 

 

(1,509)

Inventory

 

(643)

 

 

610 

Prepaid expenses and other assets

 

83 

 

 

(34)

Accounts payable

 

203 

 

 

3,662 

Accrued expenses

 

(125)

 

 

459 

Deferred service revenue

 

573 

 

 

1,582 

Deferred contractual revenue

 

(7,192)

 

 

(3,392)

Other liabilities

 

(504)

 

 

(607)

Net cash used in operating activities

 

(31,405)

 

 

(29,876)

Cash flows from investing activities

 

 

 

 

 

Purchase of property and equipment

 

(1,672)

 

 

(942)

Disposal of property and equipment

 

 

 

 —

Purchase of investments

 

(40,580)

 

 

(66,876)

Sales of investments

 

6,817 

 

 

 —

Maturities of investments

 

51,898 

 

 

76,195 

Net cash provided by investing activities

 

16,469 

 

 

8,377 

Cash flows from financing activities

 

 

 

 

 

Proceeds from issuance of common stock from equity plans

 

2,984 

 

 

2,691 

Proceeds from issuance of common stock from at-the-market equity offering, net of issuance costs

 

1,433 

 

 

20,646 

Net cash provided by financing activities

 

4,417 

 

 

23,337 

Net increase (decrease) in cash and cash equivalents

 

(10,519)

 

 

1,838 

Cash and cash equivalents at beginning of period

 

36,449 

 

 

26,362 

Cash and cash equivalents at end of period

$

25,930 

 

$

28,200 

 

 

 

 

 

 

 

See accompanying notes to the condensed consolidated financial statements.

 

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PACIFIC BIOSCIENCES OF CALIFORNIA, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

NOTE 1. OVERVIEW

Pacific Biosciences of California, Inc. (“Pacific Biosciences”, the “Company”, “we”, “us”) has commercialized the PacBio RS II Sequencing System to help scientists solve genetically complex problems. Based on our novel Single Molecule, Real-Time (SMRT®) technology, our products enable: de novo genome assembly to finish genomes in order to more fully identify, annotate and decipher genomic structures; full-length transcript analysis to improve annotations in reference genomes, characterize alternatively spliced isoforms and find novel genes; targeted sequencing to more comprehensively characterize genetic variations; and DNA base modification identification to help characterize epigenetic regulation and DNA damage. Our technology combines very high consensus accuracy and long read lengths with the ability to detect real-time kinetic information.

The names “Pacific Biosciences,” “PacBio,” “SMRT,” “SMRTbell” and our logo are our trademarks.

 

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

In the opinion of management, the accompanying unaudited Condensed Consolidated Financial Statements (“Financial Statements”) of Pacific Biosciences of California, Inc. have been prepared on a consistent basis with our December 31, 2014 audited Consolidated Financial Statements and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth herein. Certain prior year amounts in the Financial Statements and notes thereto have been reclassified to conform to the current year presentation. The Financial Statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and, as permitted by such rules and regulations, omit certain information and footnote disclosures necessary to present the statements in accordance with U.S. generally accepted accounting principles (“GAAP”). These Financial Statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014.  The results of operations for the first six-month period of 2015 are not necessarily indicative of the results to be expected for the entire fiscal year or any future periods.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes to the financial statements. Our estimates include, but are not limited to, the valuation of inventory, revenue valuation, the valuation of a  financing derivative and long-term notes, the valuation and recognition of share-based compensation, the delivery period for collaboration agreements, the useful lives assigned to long-lived assets, and the computation provisions for income taxes. Actual results could differ materially from these estimates.

During the first quarter of 2015, we revised the estimated period over which the delivery of elements pursuant to the Development, Commercialization and License Agreement (the “Roche Agreement”) with F. Hoffman-La Roche Ltd (“Roche”) is expected to occur, due to an increased level of certainty regarding the development period. As a result, we are, on a prospective basis, recognizing the remaining deferred contractual revenue associated with the upfront payment received under the Roche Agreement over the revised estimated remaining development period. For the three- and six-month periods ended June 30, 2015, this change in estimate increased contractual revenue by $1.9 million and $3.8 million, respectively, and decreased loss per share by $0.03 and $0.05, respectively.  There have been no other material changes to the critical accounting policies and estimates discussed in our Annual Report on Form 10-K for the year ended December 31, 2014.

Reclassifications

In the condensed consolidated statement of cash flows for the six months ended June 30, 2014,  certain immaterial reclassifications were made from “Prepaid expenses and other assets” to the “Other items” in order to conform to current period presentation. Such reclassifications did not impact our financial position, net loss, or cash used in operations in the condensed consolidated statement of cash flows.

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Fair Value of Financial Instruments

Assets and liabilities measured at fair value on a recurring basis

The following table sets forth the fair value of our financial assets and liabilities measured on a recurring basis as of June 30, 2015 and December 31, 2014:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 (in thousands)

June 30, 2015

 

December 31, 2014

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Level 1

 

Level 2

 

Level 3

 

Total

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and money market funds

$

18,882 

 

$

 —

 

$

 —

 

$

18,882 

 

$

21,952 

 

$

 —

 

$

 —

 

$

21,952 

Commercial paper

 

 —

 

 

7,048 

 

 

 —

 

 

7,048 

 

 

 —

 

 

14,497 

 

 

 —

 

 

14,497 

Total cash and cash equivalents

 

18,882 

 

 

7,048 

 

 

 —

 

 

25,930 

 

 

21,952 

 

 

14,497 

 

 

 —

 

 

36,449 

Investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

 —

 

 

26,024 

 

 

 —

 

 

26,024 

 

 

 —

 

 

43,653 

 

 

 —

 

 

43,653 

Corporate debt securities

 

 —

 

 

8,114 

 

 

 —

 

 

8,114 

 

 

 —

 

 

8,173 

 

 

 —

 

 

8,173 

Asset backed securities

 

 —

 

 

12,606 

 

 

 —

 

 

12,606 

 

 

 —

 

 

13,073 

 

 

 —

 

 

13,073 

Total investments

 

 —

 

 

46,744 

 

 

 —

 

 

46,744 

 

 

 —

 

 

64,899 

 

 

 —

 

 

64,899 

Total assets measured at fair value

$

18,882 

 

$

53,792 

 

$

 —

 

$

72,674 

 

$

21,952 

 

$

79,396 

 

$

 —

 

$

101,348 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financing derivative

$

 —

 

$

 —

 

$

899 

 

$

899 

 

$

 —

 

$

 —

 

$

944 

 

$

944 

 

We classify our cash deposits and money market funds within Level 1 of the fair value hierarchy because they are valued using bank balances or quoted market prices. We classify our investments as Level 2 instruments based on market pricing and other observable inputs. We did not classify any of our investments within Level 3 of the fair value hierarchy.

During the six-month periods ended June 30,  2015 and 2014, there were no impairments of our investments.

The estimated fair value of the Financing Derivative liability (as defined in Note 6 Notes Payable) was determined using Level 3 inputs, or significant unobservable inputs. Changes to the estimated fair value of the Financing Derivative are recorded in “Other income (expense), net” in the condensed consolidated statements of operations and comprehensive loss. The following table provides the changes in the estimated fair value of the Financial Derivative during the six-month period ended June 30, 2015 (in thousands):

 

 

 

 

 

 

 

 

Financial Derivative

Amount

Balance as of December 31, 2014

$

944 

Gain on change in estimated fair value

 

(45)

Balance as of June 30, 2015

$

899 

 

During the six-month period ended June 30, 2015 there were no transfers between Level 1, Level 2, or Level 3 assets or liabilities reported at fair value on a recurring basis and the valuation techniques used did not change compared to our established practice.

Financial assets and liabilities not measured at fair value on a recurring basis

The carrying amount of our accounts receivable, prepaid expenses, other current assets, accounts payable, accrued expenses and other liabilities, current,  approximate fair value due to their short maturities. The carrying value of our other liabilities, non-current, approximates fair value due to the time to maturity and prevailing market rates.

We determined the estimated fair value of the Notes (as defined in Note 6 Notes Payable) from the debt facility using Level 3 inputs, or significant unobservable inputs. The estimated fair value of the Notes was determined by comparing the difference between the estimated fair value of the Notes with and without the Financing Derivative by calculating the respective present values from future cash flows using a  weighted average market yield of 18.4% and 19.5% at June 30, 2015 and December 31, 2014, respectively.

 

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The estimated fair value and carrying value of the Notes are as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 2015

 

December 31, 2014

 

Fair Value

 

Carrying Value

 

Fair Value

 

Carrying Value

Notes payable

$

15,406 

 

$

14,567 

 

$

14,817 

 

$

14,124 

 

Net Loss per Share

The following table presents the computation of our basic and diluted net loss per share (in thousands, except per share amounts):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three-Month Periods Ended June 30,

 

Six-Month Periods Ended June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

Net loss per share

 

 

 

 

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(11,935)

 

$

(19,136)

 

$

(32,108)

 

$

(38,022)

 

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares used in computation of basic and diluted net loss per share

 

 

74,733 

  

 

70,515 

 

 

74,442 

  

 

69,195 

 

Basic and diluted net loss per share

 

$

(0.16)

 

$

(0.27)

 

$

(0.43)

 

$

(0.55)

 

 

The following were excluded from the computation of our diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect:

 

 

 

 

 

 

 

 

 

 

As of June 30,

(in thousands)

2015

 

2014

Options outstanding

18,768 

 

15,659 

Warrants to purchase common stock

5,500 

 

5,500 

 

Recent Accounting Pronouncements

On May 28, 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers, requiring an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The updated standard will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective and permits the use of either the retrospective or cumulative effect transition method. Early adoption is not permitted. The updated standard would have been effective for us in the first quarter of fiscal 2017. However, in July 2015 the FASB decided to delay the effective date of the new revenue standard by one year. Reporting entities may choose to adopt the standard as of the original effective date. We are currently evaluating the effect that the updated standard will have on our consolidated financial statements and related disclosures.

In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.  This ASU introduces an explicit requirement for management to assess if there is substantial doubt about an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. Disclosures are required if conditions give rise to substantial doubt. This ASU is effective for us in the first quarter of fiscal 2017. We are currently in the process of evaluating the impact of adopting this ASU on our financial statements and related disclosures.

In April 2015, the FASB issued ASU 2015-03, Simplifying the Presentation of Debt Issuance Costs,  which changes the presentation of debt issuance costs in financial statements. This ASU requires an entity to present such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. This ASU is effective for the Company’s annual report periods beginning after December 15, 2016 and is effective for us in the first quarter of fiscal 2017.  Early adoption is permitted. The new guidance will be applied retrospectively to each prior period presented. We are currently in the process of evaluating the impact of adopting this ASU on our financial statements and related disclosures.

 

 

 

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NOTE 3. CONTRACTUAL REVENUE

During September 2013, we entered into a Development, Commercialization and License Agreement (the “Roche Agreement”) with F. Hoffman-La Roche Ltd (“Roche”), pursuant to which we account for, and recognize as revenue, the up-front payment received thereunder using the proportional performance method over the periods in which the delivery of elements pursuant to the agreement occurs. We recognize revenue using a straight-line convention over the service periods of the deliverables as this method approximates our performance of services pursuant to the agreement. Out of the $35.0 million upfront cash payment received, quarterly amortization of $1.7 million has been recognized as contractual revenue from the fourth quarter of 2013 to the fourth quarter of 2014. Beginning in the three-month period ended March 31, 2015, we revised the estimated development period related to our contractual revenue amortization based on increasing certainty of the development time on a prospective approach. This change in estimate resulted in $1.9 million of additional contractual revenue being recognized per quarter and a total of $3.6 million as quarterly amortization.  

We recognized a total of $3.6 million and $7.2 million of amortization for the three- and six-month periods ended June 30, 2015, respectively. The additional contractual revenue due to the revision had a 100% margin and decreased our net loss for the three- and six-month periods ended June 30, 2015 by $1.9 million and $3.8 million, respectively, and decreased our net loss per share for three- and six-month periods ended June 30, 2015 by $0.03 per share and $0.05 per share, respectively. At June 30, 2015, going forward, on a prospective basis, we will recognize the remaining deferred contractual revenue of $19.3 million associated with upfront payment received under the Roche Agreement over the revised estimated remaining development period.

In addition to the deliverables above, the Roche Agreement provides for additional payments totaling up to $40.0 million upon the achievement of certain development milestones. During August 2014, we achieved the first such development milestone and we recognized the related $10.0 million as contractual revenue for the quarter ended September 30, 2014.  During April 2015, we achieved the second development milestone and we recognized the related $10.0 million as contractual revenue for the quarter ended June 30, 2015. 

 

NOTE 4. CASH, CASH EQUIVALENTS AND INVESTMENTS

The following tables summarize our cash, cash equivalents and investments as of June 30, 2015 and December 31, 2014 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 2015

 

 

 

Gross

 

Gross

 

 

 

Amortized

 

unrealized

 

unrealized

 

Fair

 

Cost

 

gains

 

losses

 

Value

Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

Cash and money market funds

$

18,882 

 

$

 —

 

$

 —

 

$

18,882 

Commercial paper

 

7,048 

 

 

 —

 

 

 —

 

 

7,048 

Total cash and cash equivalents

 

25,930 

 

 

 —

 

 

 —

 

 

25,930 

Investments:

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

26,020 

 

 

 

 

 —

 

 

26,024 

Corporate debt securities

 

8,107 

 

 

 

 

 —

 

 

8,114 

Asset backed securities

 

12,605 

 

 

 

 

 —

 

 

12,606 

Total investments

 

46,732 

 

 

12 

 

 

 —

 

 

46,744 

Total cash, cash equivalents and investments

$

72,662 

 

$

12 

 

$

 —

 

$

72,674 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2014

 

 

 

Gross

 

Gross

 

 

 

Amortized

 

unrealized

 

unrealized

 

Fair

 

Cost

 

gains

 

losses

 

Value

Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

Cash and money market funds

$

21,952 

 

$

 —

 

$

 —

 

$

21,952 

Commercial paper

 

14,496 

 

 

 

 

 —

 

 

14,497 

Total cash and cash equivalents

 

36,448 

 

 

 

 

 —

 

 

36,449 

Investments:

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

43,648 

 

 

 

 

 —

 

 

43,653 

Corporate debt securities

 

8,170 

 

 

 

 

(4)

 

 

8,173 

Asset backed securities

 

13,073 

 

 

 

 

(4)

 

 

13,073 

Total investments

 

64,891 

 

 

16 

 

 

(8)

 

 

64,899 

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Total cash, cash equivalents and investments

$

101,339 

 

$

17 

 

$

(8)

 

$

101,348 

 

The following table summarizes the contractual maturities of our cash equivalents and available-for-sale investments, excluding money market funds, as of June 30, 2015:

 

 

 

 

 

 

 

 

(in thousands)

Fair Value

Due in one year or less

$

53,792 

 

Actual maturities may differ from contractual maturities because issuers may have the right to call or prepay obligations without call or prepayment penalties. 

 

NOTE 5.  INVENTORY

Inventory

 

As of June 30, 2015 and December 31, 2014, inventory consisted of the following components:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

(in thousands)

2015

 

2014

Purchased materials

$

1,081 

 

$

3,150 

Work in process

 

6,997 

 

 

6,115 

Finished goods

 

3,900 

 

 

2,070 

Inventory

$

11,978 

 

$

11,335 

 

 

NOTE 6.  NOTES PAYABLE

Pursuant to a Facility Agreement (the “Facility Agreement”) we entered into with entities affiliated with Deerfield Management Company, L.P. (collectively, “Deerfield”) during February 2013, we issued promissory notes in the aggregate principal amount of $20.5 million (the “Notes”). The Notes bear simple interest at a rate of 8.75% per annum, payable quarterly in arrears commencing on April 1, 2013. In connection with the execution of the Facility Agreement, we issued warrants to purchase an aggregate of 5,500,000 shares of common stock immediately exercisable at an exercise price per share initially equal to $2.63 (the “Warrants”). In addition, the Facility Agreement requires us to maintain consolidated cash and cash equivalents on the last day of each calendar quarter of not less than $2.0 million. As security for our repayment of our obligations under the Facility Agreement, we granted to Deerfield a security interest in substantially all of our property.

Financing Derivative

A number of features embedded in the Notes to the Facility Agreement required accounting for as a derivative, including the indemnification of certain withholding taxes and the acceleration of debt upon (i) a qualified financing, (ii) an Event of Default, (iii) a Major Transaction, and (iv) the exercise of the warrant via offset to debt principal. These features represent a single derivative (the “Financing Derivative”) that was bifurcated from the debt instrument and accounted for as a liability at fair value, with changes in fair value between reporting periods recorded in other income (expense), net.

The estimated fair value of the Financing Derivative was determined by comparing the difference between the fair value of the Notes with and without the Financing Derivative by calculating the respective present values from future cash flows using an  18.4% and 19.5% weighted average market yield at June 30, 2015 and December 31, 2014, respectively. The estimated fair value of the Financing Derivative as of both June 30, 2015 and December 31, 2014 was $0.9 million.

Notes

We initially recorded the Notes and Warrants at $14.1 million and $6.4 million, respectively, based upon the relative fair value allocation of the $20.5 million of proceeds. The carrying value of the Notes at the inception of the debt was $12.8 million, resulting in an original issue discount of $7.7 million. As of June 30, 2015 and December 31, 2014,  debt discount of $5.9 million and $6.4 million, respectively, remained to be amortized through February 2020, the maturity of the Notes.

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NOTE 7. STOCKHOLDERS’ EQUITY AND SHARE-BASED COMPENSATION

Equity Offering

During the six-month period ended June 30, 2015, we issued 240,843 shares of our common stock at an average price of $6.13 per share through our “at-the-market” offering program, resulting in net proceeds of $1.4 million. As of June 30, 2015, $28.5 million of common stock remained available for future sales; however, we are not obligated to make any sales under this program.

Warrants

As of June 30, 2015, we had outstanding warrants to purchase an aggregate of 5,500,000 shares of our common stock.

Equity Plans

As of June 30, 2015, we had three active equity compensation plans: the 2010 Equity Incentive Plan, the 2010 Outside Director Equity Incentive Plan, and the 2010 Employee Stock Purchase Plan (“ESPP”).

The following table summarizes stock option activity for all stock option plans for the six-month period ended June 30, 2015 (in thousands, except per share amounts):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock Options Outstanding

 

 

 

 

 

 

 

 

Weighted

 

Shares available

 

Number

 

 

 

 

average

 

for grant

 

of shares

 

Exercise price

 

exercise price

Balances, December 31, 2014

4,874 

 

16,491 

 

$

 0.7016.00 

 

$

5.10 

Additional shares reserved 

4,435 

 

 

 

 

 

 

 

 

Options granted

(2,806)

 

2,806 

 

 

5.437.59 

 

 

6.46 

Options exercised

—  

 

(224)

 

 

0.705.18

 

 

3.14 

Options canceled

305 

 

(305)

 

 

1.1615.98 

 

 

5.89 

Balances, June 30, 2015

6,808 

 

18,768 

 

$

 0.7016.00 

 

$

5.32 

 

Shares issued under our ESPP totaled 532,217 and 1,048,604 shares during the six-month periods ended June 30, 2015 and 2014, respectively. As of June 30,  2015,  946,329 shares of our common stock remain available for issuance under our ESPP.

Stock-based Compensation

Total stock-based compensation expense consists of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three-Month Periods Ended June 30,

 

Six-Month Periods Ended June 30,

 

 

2015

 

2014

 

2015

 

2014

 

Cost of revenue

$

291 

 

$

121 

 

$

589 

 

$

262 

 

Research and development

 

1,235 

 

 

822 

 

 

2,490 

 

 

1,708 

 

Sales, general and administrative

 

1,794 

 

 

1,279 

 

 

3,496 

 

 

2,522 

 

Total stock-based compensation expense

$

3,320 

 

$

2,222 

 

$

6,575 

 

$

4,492 

 

 

We estimated the fair value of employee stock options on the grant date using the Black-Scholes option pricing model. The estimated fair value of employee stock options is amortized on a straight-line basis over the requisite service period of the awards. The fair value of employee stock options was estimated using the following weighted average assumptions:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three-Month Periods Ended June 30,

 

Six-Month Periods Ended June 30,

 

 

Stock Option

2015

 

2014

 

2015

 

2014

 

 

Expected term in years

6.1

 

6.1

 

6.1

 

6.1

 

 

Expected volatility

70%

 

70%

 

70%

 

70%

 

 

Risk-free interest rate

1.7%

 

1.9%

 

1.6%

 

1.9%

 

 

Dividend yield

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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We estimate the value of the employee stock purchase rights on the grant date using the Black-Scholes option pricing model. The fair value of ESPP was estimated using the following assumptions:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three-Month Periods Ended June 30,

 

Six-Month Periods Ended June 30,

 

ESPP

2015

 

2014

 

2015

 

2014

 

Expected term in years

0.5-2.0

 

0.5-2.0

 

0.5-2.0

 

0.5-2.0

 

Expected volatility

70%

 

70%

 

70%

 

70%

 

Risk-free interest rate

0.1%-0.6%

 

0.1%-0.3%

 

0.1%-0.6%

 

0.1%-0.3%

 

Dividend yield

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NOTE 8. SUBSEQUENT EVENTS

Lease Amendment Agreement

On July 23, 2015,  we entered into a Lease Amendment Agreement (the “Lease Amendment Agreement”) with Peninsula Innovation Partners, LLC (the “Existing Landlord”), which amends the terms and conditions of certain of our existing real property leases. The Lease Amendment Agreement provides for, among other things, amendments of the term for certain of the existing leases, the termination of all renewal, expansion and extension rights contained in any of the existing leases (including our options to extend the terms for certain of the existing leases for two consecutive five-year periods), as well as rent abatement for a specified period of time.  As consideration for our agreement to amend the existing leases pursuant to the Lease Amendment Agreement, and subject to the terms and conditions contained therein, we shall be eligible to receive up to four payments of $5,000,000 each from the Existing Landlord over time, and rent abatement through September 2017. If we do not obtain or waive receipt of an architectural approval and a change of use permit with respect to our proposed new premises at 1315 O’Brien Drive, Menlo Park, California (collectively, the “Use CUPs”) by September 30, 2015, (i) the Existing Landlord shall have no obligation to make the Existing Landlord payments, (ii) the amendments of the term for the existing leases shall be of no further force or effect, (iii) the period for our delivery of option notices with respect to extended terms in the applicable existing leases shall be extended until October 15, 2015, (iv) the rent abatement shall be terminated and repaid by us, and (v) certain related terms and conditions of the Lease Amendment Agreement shall be of no further force or effect.    

O’Brien Lease Agreement

 

On July 22, 2015, we entered into a new lease agreement (the “O’Brien Lease”) with Menlo Park Portfolio II, LLC (the “O’Brien Landlord”) for premises consisting of approximately one hundred eighty thousand (180,000) rentable square feet located at 1315 O’Brien Drive, Menlo Park, California (the “O’Brien Premises”). 

 

The term of the O’Brien Lease is one hundred thirty-two (132) months, commencing on the date that is the later of April 15, 2016 or the date O’Brien Landlord has substantially completed certain shell improvements and tenant improvements.  Base monthly rent shall be abated for the first six (6) months of the O’Brien Lease term and thereafter will be $540,000 per month during the first year of the lease term, with specified annual increases thereafter until reaching $711,000 per month during the last twelve (12) months of the lease term. We are required to pay $2,340,000 in prepaid rent which will be applied to the monthly rent installments due for the first to fourth months, and the operating expenses for the first month, after the rent abatement period.  In addition, we are required to provide the O’Brien Landlord with a security deposit under the O’Brien Lease in the amount of $4,500,000, which security deposit initially will be in the form of a letter of credit. The O’Brien Landlord is obligated to construct certain shell improvements at the O’Brien Landlord’s cost and expense and provide us with improvement allowances in the amount of $70.00 per rentable square foot of the Premises, which may be applied towards the costs of construction of the initial improvements in the Premises. We are required to reimburse the O’Brien Landlord for certain improvement costs in excess of the foregoing allowances.

 

Under the O’Brien Lease,  we expect to pay approximately $80 million in rent and $24 million in operating expenses over the expected lease term. In addition to the lease payments, we are also required to reimburse the O’Brien Landlord for certain improvement costs in excess of the tenant improvement allowances provided. These improvement costs, along with the costs associated with the anticipated move to the O’Brien Premises, are expected to be substantial in nature.

We have reserved the right to terminate the O’Brien Lease if the Use CUPs are not obtained by September 30, 2015, and, the O’Brien Landlord has a similar right to terminate the O’Brien Lease for failure to obtain the Use CUPs.

 

 

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes included in this Quarterly Report on Form 10-Q and those in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties, including statements regarding our expected financial results in future periods. You should read the “Risk Factors” section of this Quarterly Report on Form 10-Q for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We design, develop and manufacture the PacBio® RS II Sequencing System to help scientists resolve genetically complex problems. Based on our novel Single Molecule, Real-Time (SMRT®) technology, our products enable: de novo genome assembly to finish genomes in order to more fully identify, annotate and decipher genomic structures; full-length transcript analysis to improve annotations in reference genomes, characterize alternatively spliced isoforms and find novel genes; targeted sequencing to more comprehensively characterize genetic variations; and DNA base modification identification to help characterize epigenetic regulation and DNA damage. Our technology combines very high consensus accuracy and long read lengths with the ability to detect real-time kinetic information.

During September 2013, we entered into a Development, Commercialization and License Agreement (the “Roche Agreement”) with F. Hoffman-La Roche Ltd (“Roche”), pursuant to which we account for, and recognize as revenue, the $35.0 million up-front payment using the proportional performance method over the periods in which the delivery of elements pursuant to the agreement occurs. We recognize revenue using a straight-line convention over the service periods of the deliverables as this method approximates our performance of services pursuant to the contract. In addition to the above upfront payment, the Roche agreement provides for additional payments totaling up to $40.0 million upon the achievement of certain milestones. During August 2014, we achieved the first such development milestone and we recorded the related $10.0 million as contractual revenue for the quarter ended September 30, 2014.  During April 2015 we achieved the second development milestone and we recorded the related $10.0 million as contractual revenue for the quarter ended June 30, 2015.

Basis of Presentation

Revenue

During the three- and six-month periods ended June 30, 2015 and 2014, product revenue was primarily derived from the sale of PacBio RS II instruments and associated consumables. Service and other revenue was primarily derived from product maintenance agreements sold on our installed instruments. Contractual revenue was derived from the quarterly amortization from the non-refundable up-front payment of $35.0 million that we received in September 2013 pursuant to the Roche Agreement. In addition, we achieved the second development milestone under the Roche Agreement in April 2015 and we recorded the related $10.0 million as contractual revenue for the quarter ended June 30, 2015.

Cost of Revenue

Cost of revenue reflects the direct cost of product components, third-party manufacturing services and our internal manufacturing overhead and customer service infrastructure costs incurred to produce, deliver, maintain and support our instruments, consumables, and services. There are no incremental costs associated with our contractual revenue; all product development costs are reflected in research and development expense.

Manufacturing overhead is predominantly comprised of labor costs. We determine and capitalize manufacturing overhead into inventory based on a standard cost model that approximates actual costs.  Prior to achieving manufacturing volumes that correlated with our estimated normal capacity (the production levels expected to be achieved over a number of periods under normal circumstances with available resources), we based our capitalized overhead relative to our normal capacity.  Prior to achieving normal capacity, excess manufacturing resources were engaged in research and development activities, including:  next generation products, internal use research products, and general support activities. As such, manufacturing costs in excess of amounts reflected in inventory were expensed as a component of research and development expense. During 2014, manufacturing volumes trended towards and then approximated normal capacity, and excess manufacturing resources contributing to research and development activities declined significantly.

Service costs include the direct costs of components used in support, repair and maintenance of customer instruments as well as the cost of personnel, materials, shipping and support infrastructure necessary to support the installed customer base.

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Research and Development Expense

Research and development expense consists primarily of expenses for personnel engaged in the development of our SMRT technology, the design and development of our future products and current product enhancements. These expenses also include prototype-related expenditures, development equipment and supplies, facilities costs and other related overhead. We expense research and development costs during the period in which the costs are incurred. However, we defer and capitalize non-refundable advance payments made for research and development activities until the related goods are received or the related services are rendered.

Sales, General and Administrative Expense 

Selling, general and administrative expenses include costs for sales, marketing and administrative personnel, sales and marketing activities, tradeshow expenses, legal expenses and general corporate expenses.

Interest Expense

Interest expense is primarily related to our debt facility and includes the amortization of debt discount and other related costs. To a lesser extent, amounts also include interest expense relating to our facility financing obligations resulting from a lease agreement entered into in 2010. We expect interest expense to increase during future periods as the recorded value of our debt facility accretes to the amount due at maturity.

Other Income (Expense), Net

Other income (expense), net consists primarily of interest income earned on cash and investments, accretion of discounts and amortization of premiums related to investments, net gains or losses on foreign currency transactions, net gains or losses resulting from changes in the estimated fair value of the financing derivative and foreign income taxes.

Income Taxes

Since inception, we have incurred net losses and have not recorded any U.S. federal or state income tax benefits for such losses as they have been fully offset by valuation allowances.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations are based upon our unaudited financial statements, which have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”). The preparation of these Financial Statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our critical accounting policies and estimates. 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 the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

During the first quarter of 2015, we revised the estimated period over which the delivery of elements pursuant to the Development, Commercialization and License Agreement (the “Roche Agreement”) with F. Hoffman-La Roche Ltd (“Roche”) is expected to occur, due to an increased level of certainty regarding the development period. As a result, we are, on a prospective basis, recognizing the remaining deferred contractual revenue associated with the upfront payment received under the Roche Agreement over the revised estimated remaining development period. For the three- and six-month periods ended June 30, 2015, this change in estimate increased contractual revenue by $1.9 million and $3.8 million, respectively, and decreased loss per share by $0.03 and $0.05, respectively.  There have been no other material changes to the critical accounting policies and estimates discussed in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

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Results of Operations

Comparison of the Three-month Periods Ended June 30,  2015 and 2014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three-Month Periods Ended June 30,

 

$ Change

 

% Change

(in thousands, except percentages)

2015

 

2014

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

Product revenue

$

8,825 

 

$

7,749 

 

$

1,076 

 

14% 

Service and other revenue

 

2,518 

 

 

1,980 

 

 

538 

 

27% 

Contractual revenue

 

13,596 

 

 

1,696 

 

 

11,900 

 

702% 

Total revenue

 

24,939 

 

 

11,425 

 

 

13,514 

 

118% 

Cost of Revenue:

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

8,438 

 

 

6,271 

 

 

2,167 

 

35% 

Cost of service and other revenue

 

1,995 

 

 

2,028 

 

 

(33)

 

(2%)

Total cost of revenue

 

10,433 

 

 

8,299 

 

 

2,134 

 

26% 

Gross profit

 

14,506 

 

 

3,126 

 

 

11,380 

 

364% 

Operating Expense:

 

 

 

 

 

 

 

 

 

 

Research and development

 

15,043 

 

 

12,435 

 

 

2,608 

 

21% 

Sales, general and administrative

 

10,821 

 

 

8,993 

 

 

1,828 

 

20% 

Total operating expense

 

25,864 

 

 

21,428 

 

 

4,436 

 

21% 

Operating loss

 

(11,358)

 

 

(18,302)

 

 

6,944 

 

38% 

Interest expense

 

(715)

 

 

(701)

 

 

(14)

 

(2%)

Other income (expense), net

 

138 

 

 

(133)

 

 

271 

 

204% 

Net loss

$

(11,935)

 

$

(19,136)

 

$

7,201 

 

38% 

 

 

Revenue

Total revenue for the three-month period ended June 30, 2015 was $24.9 million compared to $11.4 million for the same period during 2014.

Product revenue during the three-month period ended June 30, 2015 consisted of $4.3 million from sales of PacBio RS II instruments and $4.5 million from sales of consumables, compared to $4.7 million from sales of instruments and $3.0 million from sales of consumables for the same period during 2014. The increase in consumable sales is primarily attributable to a larger installed base and higher utilization of installed instruments by our customers.

Service and other revenue