8-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15 (D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): November 29, 2007
(November 28, 2007)
REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
New York
(State or other jurisdiction of incorporation)
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000-19034
(Commission File No.)
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13-3444607
(IRS Employer Identification No.) |
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777 Old Saw Mill River Road, Tarrytown, New York
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10591-6707 |
(Address of principal executive offices)
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(Zip Code) |
(914) 347-7000
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c)) |
TABLE OF CONTENTS
Item 1.01. Entry Into a Material Definitive Agreement.
Collaboration Agreements
On November 28, 2007, Regeneron Pharmaceuticals, Inc. (the Company) entered into a global,
strategic collaboration with various affiliates of sanofi-aventis, a company organized under the
laws of France (sanofi-aventis and its affiliates are referred to herein as Sanofi), to discover,
develop and commercialize fully-human therapeutic antibodies (the Collaboration). The Collaboration is governed by a Discovery and Preclinical
Development Agreement, dated November 28, 2007 (the Discovery Agreement), by and between Aventis
Pharmaceuticals Inc. and the Company, and a License and Collaboration Agreement, dated November 28,
2007, by and among Aventis Pharmaceuticals Inc., sanofi-aventis Amérique du Nord and the Company
(the License and Collaboration Agreement and, together with the Discovery Agreement, the
Collaboration Agreements).
The Discovery Agreement provides for an $85 million upfront payment to the Company and up to
$475 million of funding for identifying and validating potential drug discovery targets and
developing fully-human therapeutic antibodies against such targets (the Discovery Program) over
the next five years. Sanofi also has an option to extend the Discovery Program for up to an
additional three years for further antibody development and preclinical activities. The Company
will lead the design and conduct of research activities, including target identification and
validation, antibody development, research and preclinical activities through filing of an
Investigational New Drug Application, toxicology studies and manufacture of preclinical and
clinical supplies.
For each drug candidate identified, Sanofi will have the option to license rights to the
candidate under the License and Collaboration Agreement. If it elects to do so, it will co-develop
the drug candidate with the Company through product approval. Development costs will be shared
between Sanofi and the Company, with Sanofi funding drug candidate development costs up front and
the Company reimbursing half of the total development costs for all Collaboration products from its
share of future profits to the extent they are sufficient for this purpose. If Sanofi does not
exercise its option to license rights to a particular drug candidate under the License and
Collaboration Agreement, the Company will retain the exclusive right to develop and commercialize
such drug candidate, and Sanofi will receive a royalty on sales.
Sanofi will lead commercialization activities for products developed under the License and
Collaboration Agreement, subject to the Companys right to co-promote such products. The parties
will equally share profits from sales within the United States and will share profits outside the
United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (Company) and ending
at 55% (Sanofi)/45% (Company). The parties have also agreed to share losses associated with
commercialization. In addition to profit sharing, the Company is entitled to receive up to $250
million in sales milestone payments, with milestone payments commencing after aggregate annual
sales outside the United States exceed $1 billion on a rolling twelve month basis.
With respect to each antibody product which enters development under the License and
Collaboration Agreement, Sanofi or the Company may, by giving twelve months notice, opt-out of
further development and/or commercialization of the product, in which event the other party retains
exclusive rights to continue the development and/or commercialization of the product. Each of the
Discovery Agreement and the License and Collaboration Agreement contains other termination
provisions, including for material breach by the other
party and, in the case of the Discovery Agreement, a termination right for Sanofi under
certain circumstances, including if certain minimal criteria for the Discovery Program are not
achieved.
Equity Placement
The Company has agreed to sell to Sanofi 12,000,000 shares of its Common Stock, par value
$0.001 per share (the Common Stock), at an aggregate cash price of $312 million, or $26.00 per
share of Common Stock, pursuant to the terms of a Stock Purchase Agreement, dated November 28,
2007, by and among sanofi-aventis Amérique du Nord, sanofi-aventis US LLC and the Company (the
Transaction). This sale does not involve any public offering and is therefore exempt from
registration under Section 4(2) of the Securities Act of 1933, as amended (the Securities Act).
Based on 63,932,731 shares of Common Stock outstanding as of November 28, 2007, the Transaction
will increase Sanofis beneficial ownership of Common Stock from approximately 4% to approximately
19%. Subject to the expiration or earlier termination of the Hart-Scott-Rodino waiting period and
other customary closing conditions, the Transaction is expected to close near the end of 2007.
As a condition to the closing of the Transaction, Sanofi will enter into an Investor Agreement
with the Company. Under the Investor Agreement, Sanofi will have three demand rights to require
the Company to conduct a registered underwritten public offering with respect to shares of the
Companys Common Stock beneficially owned by Sanofi immediately after the closing of the
Transaction. Until the later of the fifth anniversaries of the expiration or earlier termination
of the License and Collaboration Agreement and the Companys existing collaboration agreement with
Aventis Pharmaceuticals Inc. for the development and commercialization of the VEGF Trap, Sanofi
will be bound by certain standstill provisions which modify the standstill agreement to which
Sanofi is currently subject. These new provisions include an agreement not to acquire more than a
specified limit of the outstanding shares of Common Stock and Class A Stock, par value $0.001 per
share, of the Company (Class A Stock). The limit will initially be 25% and will increase to 30%
after the fourth anniversary of the closing of the Transaction. Sanofi has also agreed not to
dispose of any shares of Common Stock beneficially owned by it immediately after the closing of the
Transaction until the fifth anniversary of the closing of the Transaction, subject to certain
limited exceptions. Following such fifth anniversary, Sanofi will be permitted to sell such shares
of Common Stock (i) in a registered underwritten public offering, subject to the underwriters
broad distribution of securities sold, (ii) pursuant to Rule 144 under the Securities Act and
transactions exempt from registration under the Securities Act, subject to a volume limitation of
one million shares of Common Stock every three months and a prohibition on selling to beneficial
owners, or persons that would become beneficial owners as a result of such sale, of 5% or more of
the outstanding shares of Common Stock and (iii) into an issuer tender offer, or a tender offer by
a third party that is recommended or not opposed by the Companys Board of Directors. Sanofi has
agreed to vote, and cause its affiliates to vote, all shares of Regenerons voting securities they
are entitled to vote, at Sanofis election, either as recommended by Regenerons Board of Directors
or proportionally with the votes cast by other Regeneron shareholders, except with respect to
certain change of control transactions, liquidation or dissolution, stock issuances equal to or
exceeding 10% of the then outstanding shares or voting rights of Common Stock and Class A Stock,
and new equity compensation plans or amendments if not materially consistent with Regenerons
historical equity compensation practices. The rights and restrictions under the Investor Agreement
are subject to termination upon the occurrence of certain events.
The press release issued by the Company, dated November 29, 2007, contains further information
concerning the Collaboration and the Transaction. A copy of this press release is attached to this
Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Item 3.02. Unregistered Sales of Equity Securities.
The information set forth under the heading Equity Placement in Item 1.01 is incorporated
herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Document |
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99.1
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Press Release issued by the Company, dated November 29, 2007 |
SIGNATURE
Pursuant to the requirements of 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.
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REGENERON PHARMACEUTICALS, INC.
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Date: November 29, 2007 |
By: |
/s/ Stuart Kolinski
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Name: |
Stuart Kolinski |
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Title: |
Senior Vice President and General Counsel |
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Exhibit Index
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Number |
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Description |
99.1
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Press Release issued by the Company, dated November 29, 2007 |