UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
SCHEDULE
14D-9
(Rule
14d-101)
Solicitation/Recommendation
Statement
Under
Section 14(d)(4) of the Securities Exchange Act of 1934
NOVEN
PHARMACEUTICALS, INC.
(Name of
Subject Company)
NOVEN
PHARMACEUTICALS, INC.
(Name of
Person Filing Statement)
Common
Stock, par value $.0001 per share
(Title of
Class of Securities)
670009109
(Cusip
Number of Class of Securities)
Peter
Brandt
President
and Chief Executive Officer
Noven
Pharmaceuticals, Inc.
11960
S.W. 144th Street
Miami,
Florida 33186
305-253-5099
(Name,
address and telephone number of person authorized to
receive
notices and communications on behalf of
the
person(s) filing statement)
With
a copy to:
Richard
Hall, Esq.
Cravath,
Swaine & Moore LLP
Worldwide
Plaza
825
Eighth Avenue
New
York, New York 10019
(212)
474-1293
|
þ
|
Check
the box if the filing relates solely to preliminary communications made
before the commencement of a tender
offer.
|
The
following e-mail to employees of Noven Pharmaceuticals, Inc. was sent on July
14, 2009:
To My
Noven Colleagues:
As the
attached press releases indicate, today is an outstanding day for Noven and for
all Noven employees.
First,
early this morning, we entered into a merger agreement for the proposed
acquisition of our company by Hisamitsu, a global pharmaceutical company based
in Japan that is the world’s largest manufacturer of transdermal
patches. Hisamitsu plans to expand its U.S. presence, and the company
that you built is their chosen catalyst. Noven is expected to serve
as Hisamitsu’s U.S. growth platform across all key functions, including Research
and Development, Operations, Clinical/Regulatory, and Marketing and
Sales. The plan calls for Noven to continue as a standalone business
unit, operating at our current locations in Miami and New York, with our
existing work force intact. The plan also calls for new leadership –
I am very pleased to report that, after closing, Jeff Eisenberg, Noven’s
Executive Vice President and President of Novogyne, will assume my
responsibilities and be named President & CEO of Noven, leading the company
on its growth course as a Hisamitsu subsidiary. We will be discussing
much more about the proposed merger at today’s Employee Town Meeting, scheduled
for 11:00 a.m. ET in the Vineyard auditorium.
Somewhat
overshadowed by the merger news is a Noven achievement that is outstanding in
its own right. This morning, we also announced results from our Phase
2 study of Mesafem, our non-hormonal therapy for menopausal hot
flashes. Along with the entire Noven Clinical Team, I am excited to
report that the study results exceeded all of our internal
expectations. With the data from this study, we plan to expedite
Mesafem into Phase 3, and to advance our Mesafem commercialization and
partnering strategies – more on this as well at the Town Meeting.
I look
forward to discussing these developments with you later this
morning.
Peter
Note: Due to the tender offer involved in the proposed merger, you
will be seeing the following legend, required by the securities laws, on some of
our written company communications.
The
tender offer described herein has not yet commenced and this communication
is neither an offer to purchase nor the solicitation of an offer to sell any
securities. At an appropriate time, Noven intends to file a tender
offer solicitation/recommendation statement, and Hisamitsu intends to file a
Schedule TO and related documents (together with the tender
offer solicitation/recommendation statement, the “Tender Offer Documents”)
with the Securities and Exchange Commission (SEC). Investors and
security holders are urged to read the Tender Offer Documents and any other
relevant documents filed with the SEC when they become available, because they
will contain important information. Investors and security holders
may obtain a free copy of the Tender Offer Documents and other documents (when
available) that Noven or Hisamitsu files with the SEC at the SEC’s website at
www.sec.gov. In addition, the tender offer
solicitation/recommendation statement and other documents filed by Noven with
the SEC may be obtained from Noven free of charge by directing a request to
Joseph C. Jones, Noven’s Vice President – Corporate Affairs, at
305-253-1916.
The
following presentation material was made available by Noven Pharmaceuticals,
Inc. to its employees on July 14, 2009:
NOVEN
Special Town Meeting July 14, 2009
Forward
Looking Statements Except for historical information contained herein, the
matters discussed in this presentation contain forward-looking statements that
involve substantial risks and uncertainties. Statements that are not
historical facts, including statements that are preceded by, followed by, or
that include, the words “believes,” “anticipates,” “plans,” “expects” or similar
expressions, and statements that involve risks and uncertainties concerning
Hisamitsu’s acquisition of Noven, are forward-looking
statements. Noven’s estimated or anticipated future results, product
performance or other non-historical facts are forward-looking and reflect
Noven’s current perspective on existing trends and
information. Actual results, performance or achievements could differ
materially from those contemplated, expressed or implied by the forward-looking
statements contained herein. These forward-looking statements are
based largely on the current expectations of Noven and, where applicable,
Hisamitsu, and are subject to a number of risks and uncertainties that are
subject to change based on factors that are, in many instances, beyond Noven’s
and Hisamitsu’s control. These factors include, but are not limited
to, the timing and completion of the proposed tender offer for the outstanding
shares of Noven, the ability to complete the tender offer and subsequent merger
successfully, in a timely fashion and on the terms agreed to by the parties, and
the anticipated impact of the acquisition on Noven’s or Hisamitsu’s operations
and financial results. Accordingly, no assurances can be given that any of the
events anticipated by the forward-looking statements will occur or, if any of
them do, what impact they will have on either Noven’s or Hisamitsu’s results of
operations or financial condition. Unless required by law, Noven and
Hisamitsu undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
Important
Information about the Tender Offer The tender offer described in this
presentation has not yet commenced and this communication is neither an offer to
purchase nor the solicitation of an offer to sell any securities. At
an appropriate time and if the tender offer is commenced, Noven intends to file
a tender offer solicitation/recommendation statement with the
SEC. Investors and security holders are urged to read the tender
offer solicitation/recommendation statement and any other relevant documents
filed with the SEC when they become available, because they will contain
important information. Investors and security holders may obtain a
free copy of the tender offer solicitation/recommendation statement and other
documents (when available) that Noven files with the SEC at
www.sec.gov. In addition, the tender offer
solicitation/recommendation statement and other documents filed by Noven with
the SEC may be obtained from Noven free of charge by directing a request to
Noven Corporate Affairs at 305-964-3182.
Meeting
Agenda The Noven / Hisamitsu Transaction This Morning’s News About Hisamitsu
About the Proposed Transaction What This Means for Noven What This Means for
Employees Mesafem Phase 2 Study Results Exceeded Expectations Next Steps for
Mesafem Questions
This
Morning’s News Noven and Hisamitsu Enter into Definitive Merger Agreement
Hisamitsu Expected to Commence an All-Cash Tender Offer for 100% of Outstanding
Noven Shares Noven’s Existing Operations Expected to Serve as Combined Company’s
Growth Platform
Key
Transaction Terms Transaction Value $16.50 per common share Consideration $100%
Cash Structure Noven to become a wholly-owned sub of Hisamitsu Tender Required
Greater than 50% of shares outstanding Expected Closing Date Tender offer
expected to commence by July 28, 2009 Expected to close Q3
2009
Noven
/ Hisamitsu Strategic Vision The combined company would be positioned for
significant growth in the U.S. market and global transdermal leadership U.S.
Objective: The transaction positions Noven as Hisamitsu’s platform for U.S.
expansion across all functions, including product development, operations,
clinical/regulatory and commercial capabilities. Global Objective: The
transaction is a major step toward Hisamitsu’s long-term corporate objective to
be the world’s leading transdermal company.
Meaningful
Benefits for All Constituents For Shareholders: a 43% premium over Noven’s
90-day average closing stock price For Employees: continued and enhanced
opportunities as an integral part of global leader’s U.S. growth strategy For
Partners: working with a stronger, better-resourced collaborative partner in
Noven For Physicians/Patients/Customers: continued service, quality and
therapeutic benefit, with the potential for access to a broader product line For
Vendors/Suppliers: opportunities for expansion of existing business
relationships as Noven grows
Who
is Hisamitsu? The world’s largest patch manufacturer 4 billion units per
year Our trusted and respected partner and long-time shareholder
Parties have worked together on several product opportunities Hisamitsu has held
over 1.0 million shares of Noven since 2002 Currently holds 4.9% of outstanding
Noven common stock
Hisamitsu
Corporate Profile Established: 1847 Stock Exchange: Tokyo (since 1972) Annual
Sales: $1.3 billion in FY2/2009 Employees: Over 1,890 Headquarters: Tosu and
Tokyo Global Offices: 26 Foctories: Tosu and Utsunomiya (Japan) Vietnam, Brazil,
Taian and Indonesia Laboratories: Tosu, Tsukuba (Japan) and San
Diego
Hisamitsu
Legacy – Excellence Since 1847 Salonpas® Pain Relief Patch/Arthritis Pain
launched in the US 2008 160 year anniversary 2007 Acquired Ethical Drug Division
of SSP Keplat® (Mohrus Tape) launched in Italian market 2005 Feitas®,
Butenalock® launched 2003 Estrana® (estradiol patch) introduced to the market
2000 Mohrus Tape® (ketoprofen patch) launched 1995 Mohrus® (ketoprofen gel
patch) launched 1988 1987 Hisamitsu America, Inc. established 1972 Papsalon®
launched (first Rx product) 1962 Public listing of stock 1937 Overseas export of
Salonpas® started 1934 Salonpas® introduced to the market 1847
Founded
Established
Global Presence Hisamitsu America, Inc. Hisamitsu UK Headquarters Kyushu Tokyo
New Jersey Office Taiwan Hisamitsu Pharmaceutical California
Laboratories Hisamitsu Vietnam Pharmaceutical Hisamitsu Taipei Regional Office
Hisamitsu Pharmaceutica do Brazil Ltda. Hisamitsu Malaysia Regional Office P.T.
Hisamitsu Pharma Indonesia Hisamitsu Singapore Branch
Substantial
Presence in Japan Kyushu Head office Laboratories Factories Sapporo branch
office Sendai branch office Kanazawa sales office Saitama sales office Kyoto
branch office Osaka 1st branch office Osaka 2nd branch office Hiroshima branch
office Kobe sales office Fukuoka branch office Kumamoto branch office Takamatsu
branch office Kagoshima branch office Yokohama sales office Nagoya branch office
Utsunomiya sales office Utsunomiya Factories Tsukuba Laboratories Tokyo 1st
branch office Tokyo 2nd branch office Johtoh sales office Tokyo head office
Chiba sales office
Consistent
Growth Revenue (JPY Million 120,000 100,000 80,000 60,000 40,000 20,000 0 01-09
CAGR: 8.4% Net Income (JPY Million) 65,240 69,538 70,000 74,588 83,545 102,665
109,791 119,061 124,655 10.4% 6,788 8,608 9,599 10,823 12,873 14,448 15,847
18,663 15.3% 19,120 24,000 20,000 16,000 12,000 8,000 4,000 0 FY2/01 FY2/02
FY2/03 FY2/04 FY2/05 FY2/06 FY2/07 FY2/08 FY2/09
Prescription
Products PRODUCTS Mohrus® Tape Mohrus® Sector® Naboal® Inside® Vesicum® Estrana®
Volley® ACTIVE INGREDIENT Ketoprofen Diclofenac Indomethacine Ibuprofen-piconol
Estradiol Butenafin FORMULATION Matrix patch Poultice Gel, Cream, Lotion Gel,
Poultice, Matrix patch Poultice Ointment, Cream Matrix patch Cream, Lotion
INDICATION Analgesic Anti-inflammatory Post menopausal Osteoporosis Anti-fungal
DIAGNOSIS Orthopedics Gynecology Dermatology
Over-the-Counter
Products PRODUCTS Salonpas® Salonsip® Air Salonpas® Series Feitas® Series
Butenalock® Series ACTIVE INGREDIENT Methyl salicylate Glycol salicylate,
Indomethacin Methyl salicylate, Glycol salicylate, Indomethacin Ferubinac
Butenafin FORMULATION Plaster Poultice Spray Plaster, Lotion, Cream, Stick
Cream, Liquid, Spray INDICATION Analgesic Anti-inflammatory
Anti-fungal
Late
Stage R&D Pipeline STAGE Approved Filed Phase 3 Phase 2 PRODUCT SG-01
(Product Name: Care Sheet) HFT-290 BTDS KPT-220 (Mohrus Tape) HFG-512 HKT-500
HTU-520 HOB-294 INGREDIENT ___ Fentanyl citrate Buprenorphine Ketoprofen
Fentanyl Ketoprofen Undisclosed Oxybutynin hydrochloride FEATURE
Hydrocolloide preparation absorbant, moderately moist environment Once-a-day
application for more stable pain control Moderate to severe non-malignant
chronic pain which is non-responsive to NSAIDs Extended indication of Mohrus®
Tape Generic version of Duragesic® Development of Mohrus® Tape in U.S. External
formulation for onychomycosis Stable efficacy with less adverse reactions MARKET
JPN JPN JPN JPN USA USA JPN JPN INDICATION Wound protection dressing (medical
device) Cancer pain Non-malignant chronic pain Rheumatoid arthritis Chronic pain
Mild to moderate musculoskeletal pain Onychomycosis OAB
What
Does This Mean For Noven? 1. We currently expect to continue to operate as a
standalone business unit, operating at our current locations 2. We expect to
serve as Hisamitsu’s U.S. growth platform across all key company business
segments 3. Our technology & products will be positioned to serve global
markets and a broader patient population 4. Our workforce and management team
are expected to remain in place, except for one change: After closing, Jeff
Eisenberg is expected to assume the role of Noven’s President & CEO from
Peter Brandt 5. We will no longer be a public company
We
Will No Longer Be a Publicly-Traded Company Current Status Public Shareholders
Stock Listed on NASDAQ 100% NOVEN Post-Transaction Hisamitsu Stock No Longer
Listed 100% (wholly owned subsidiary) NOVEN
What
Does This Mean for Employees? 1. This is not
about cost cutting – it is about growth and expansion in the U.S. &
elsewhere 2. Key functions expected to continue, including R&D, Operations,
Clinical/Regulatory and Sales & Marketing (both Novogyne & Noven
Therapeutics) 3. Miami and New York facilities expected to stay open 4.No
expectation of employee headcount reductions 5. New long-term incentive programs
planned
Our
Focus Must Remain on Key Success Factors Higher growth for longer term Advance
New Product Pipeline (Oral & Patch) 10 New transdermal technologies / Strong
IP 8 Smart, Aggressive Busienss Development 9 Near-term Opportunities Maximinze
Novogyne Opportunities 5 Optimize Daytrana / Improve Margins 6 Achieve
Profitability at Therapeutics 7 Organizational Improvements Growth-Oriented
Mission, Values & Focus 1 New Leadership / Stronger Team 2
Performance-Driven Culture / Accountability Financial Discipline / Bottom-Line
Focus 4
Major
Progress to Report on Key Factor #10 Significant Opportunity in Women’s Health
6M 7M 12M Not treated with Rx product Currently treated with HT Previously
treated with HT Non-hormonal therapy for VMS – VMS: hot flashes/night sweats
associated with menopause Low-dose paroxetine mesylate (oral) Excellent fit with
Noven’s menopausal therapy expertise established through Novogyne Large unmet
need – Est. 25M women with VMS
Just
Announced: Positive Phase 2 Results Double-blind, placebo-controlled Phase 2
study Designed and powered to detect an efficacy signal - 103 patients enrolled;
98 completed - Study not
designed to reach statistical significance - Goal was to detect an efficacy
signal Study results exceeded our internal expectations Achieved statistical
significance in several primary efficacy measures, and showed a clear signal in
all others - Safety and tolerability were similar to placebo - Next step: Phase
3 studies, beginning by year-end
What’s
Next - Integration Planning & Execution Detailed integration planning begins
today Execution of integration plan begins at closing Process, once begun, must
move with sense of urgency All employees are expected to have a role, some
greater than others More integration information to come
A
Word from the Noven Board Wayne Yetter Chairman of the Board Noven
Pharmaceuticals, Inc.
Questions?
Questions are welcome either now, or later by email or voicemail By email:
info@Noven.com By voicemail: x3277 (305-964-3277) Answers will be
distributed to all employees, along with updates on the transaction and
integration
NOVEN
Special Town Meeting July 14, 2009