8-K
Table of Contents

 
 
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)
     
000-19034
(Commission File No.)
  13-3444607
(IRS Employer Identification No.)
     
777 Old Saw Mill River Road, Tarrytown, New York   10591-6707
(Address of principal executive offices)   (Zip Code)
(914) 347-7000
(Registrant’s 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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))
 
 

 


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Item 1.01. Entry Into a Material Definitive Agreement
Item 3.02. Unregistered Sales of Equity Securities
Item 9.01 Financial Statements and Exhibits
SIGNATURE
Exhibit Index
EX-99.1: PRESS RELEASE


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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 Company’s 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

 


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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 Sanofi’s 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 Company’s 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 Company’s 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 underwriter’s 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 Company’s Board of Directors. Sanofi has agreed to vote, and cause its affiliates to vote, all shares of Regeneron’s voting securities they are entitled to vote, at Sanofi’s election, either as recommended by Regeneron’s 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 Regeneron’s historical equity compensation practices. The rights and restrictions under the Investor Agreement are subject to termination upon the occurrence of certain events.

 


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     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.
     
Exhibit No.   Document
 
   
99.1
  Press Release issued by the Company, dated November 29, 2007

 


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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.
         
  REGENERON PHARMACEUTICALS, INC.
 
 
Date: November 29, 2007  By:   /s/ Stuart Kolinski    
    Name:   Stuart Kolinski   
    Title:   Senior Vice President and General Counsel   

 


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Exhibit Index
     
Number   Description
99.1
  Press Release issued by the Company, dated November 29, 2007

 

EX-99.1
 

Exhibit 99.1
FOR IMMEDIATE RELEASE
Regeneron Initiates Major Global Collaboration with Sanofi-aventis
to Develop and Commercialize Fully-Human Therapeutic Antibodies
Sanofi-aventis plans to increase its stake in Regeneron to approximately 19%
Tarrytown, NY – November 29, 2007 – Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and sanofi-aventis (Euronext: SAN and NYSE: SNY) announced today that they have entered into a global, strategic collaboration agreement to discover, develop, and commercialize fully-human therapeutic antibodies utilizing Regeneron’s proprietary VelociSuite of technologies (including VelocImmune®).
Sanofi-aventis will also increase its ownership of Regeneron’s outstanding common stock from approximately 4 percent to approximately 19 percent by purchasing 12 million newly issued shares of Regeneron common stock at a price of $26.00 per share, subject to customary closing conditions including antitrust clearance.
As part of the research agreement, sanofi-aventis will make an $85 million upfront payment to Regeneron and will fund up to $475 million of research over the next five years. Sanofi-aventis will have an option to extend the research agreement for up to an additional three years.
Sanofi-aventis will have the exclusive option to co-develop with Regeneron each drug candidate in the collaboration portfolio. Development costs will be shared between the two companies, with sanofi-aventis funding drug candidate development costs up front and Regeneron reimbursing half of the development costs from its share of future profits to the extent they are sufficient for this purpose.
The first therapeutic antibody to enter clinical development under the collaboration is an antibody to the Interleukin-6 receptor (IL-6R), which has started clinical trials in rheumatoid arthritis. The second is expected to be an antibody to Delta-like ligand-4 (Dll4), which is currently slated to start its clinical development in 2008.
For any new product successfully developed as part of the collaboration, sanofi-aventis will take the lead in commercialization activities and will consolidate the sales. Regeneron will have the right to co-promote any and all collaboration products worldwide. In the United States, profits will be shared equally. Outside the United States, profits will be split on a pre-determined sliding scale with sanofi-aventis’ share ranging from 65 percent to 55 percent. In addition, Regeneron will be entitled to receive up to a total of $250 million of sales milestone payments when the collaboration achieves certain aggregate annual ex-U.S. sales levels, starting at $1 billion.

 


 

Conference call
Sanofi-aventis will host a conference call to discuss the new collaboration today, November 29, 2007, at 12:00 Paris time. It will also be available in a hear-only mode on the sanofi-aventis website: http://www.sanofi-aventis.com.
Participant access number:
France: +33 (0)1 70 99 42 99
UK: +44 (0)20 7806 1967
US: +1 718 354 1391
Regeneron will host a conference call to discuss the new collaboration today, November 29, 2007, at 8:30 a.m., Eastern Time. The dial-in information is:
Domestic Dial-in Number (866) 700-0161
International Dial-in Number: (617) 213-8832
Participant Passcode: 82276731
The slides and management discussion will be available on the Regeneron website: http://www.regeneron.com on the presentation page of the Investor Relations section at the time of the presentation.
The replay of the Regeneron presentation will be available beginning at approximately 10:30 a.m. Eastern Time on November 29, 2007 and will end on December 13, 2007. The presentation may be accessed through the Regeneron website: http://www.regeneron.com on the presentation page of the Investor Relations section or using the following information:
Domestic Dial-in Number: (888) 286-8010
International Dial-in Number: (617) 801-6888
Passcode: 53180945
About the Regeneron VelociSuite of Technologies
Regeneron has developed and validated a group of novel technology platforms, known as the VelociSuite of technologies, to improve its ability to develop new product candidates. VelociGene® and VelociMouse™ are designed to aid in the identification of specific genes of therapeutic interest for a particular disease or cell type and validate targets through high-throughput production of mammalian models. VelocImmune® increases the speed and efficiency of fully-human therapeutic monoclonal antibody development and is currently being used to generate antibodies to address clinically relevant targets of therapeutic interest.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).

 


 

About Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions.  Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron’s worldwide web site at www.regeneron.com
Forward Looking Statement
This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of our drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize our drug candidates, competing drugs that are superior to our product candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including our agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks.  A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission (SEC), including its Form 10-Q for the quarter ended September 30, 2007.  Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.
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Contact Information:
Regeneron Pharmaceuticals, Inc.
Charles Poole
Vice President, Investor Relations
1.914.345.7640
charles.poole@regeneron.com
Laura Lindsay
Media Relations
1.914.345.7800
laura.lindsay@regeneron.com
Kimberly Chen
Media Relations
1.212.845.5634
kchen@biosector2.com