UNITED STATES
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): May 6, 2013 (May 2, 2013)
REGENERON PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| New York | 000-19034 | 13-3444607 | ||
| (State or other jurisdiction of Incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
777 Old Saw Mill River Road, Tarrytown, New York 10591-6707
(Address of principal executive offices, including zip code)
(914) 847-7000
(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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 1.01 | Entry into a Material Definitive Agreement. |
Regeneron Pharmaceuticals, Inc. (the “Company”) and various affiliates of Sanofi (referred to herein with its affiliates as “Sanofi”) are engaged in a global, strategic collaboration to discover, develop and commercialize fully-human therapeutic antibodies (the “Collaboration”). The Collaboration is governed by an Amended and Restated Discovery and Preclinical Agreement and an Amended and Restated License and Collaboration Agreement (the “Amended and Restated License Agreement”).
On May 2, 2013, the Company entered into two agreements with Sanofi by which the Company acquired rights to two families of antibodies invented at Regeneron and previously included in the Collaboration.
The first of these agreements was the First Amendment to Amended and Restated License and Collaboration Agreement pursuant to which the Company acquired exclusive rights in ophthalmology to antibodies targeting the angiopoietin2 (“ANG2”) receptor and ligand (the “ANG2 Amendment”). The Company will make a $10 million upfront payment to Sanofi within five business days of the effective date of the agreement. In addition, Sanofi may receive a potential $5 million development milestone payment and royalties on any future sales. The Company will be solely responsible for the cost of developing antibodies to ANG2 in ophthalmology. Antibodies to ANG2 outside of ophthalmology will continue to be developed by the Company and Sanofi under the Amended and Restated License Agreement, including REGN910 (SAR 307746), an antibody to ANG2 that is currently in Phase 1 development in patients with advanced malignancies.
The second of these agreements was a letter agreement related to antibodies targeting the platelet derived growth factor (“PDGF”) family of receptors and ligand (the “PDGF Agreement”). Pursuant to the PDGF Agreement, the Company acquired exclusive rights to antibodies targeting PDGF in ophthalmology and all other indications. The Company will make a $10 million upfront payment to Sanofi within five business days of the effective date of the agreement. In addition, Sanofi may receive up to $40 million in development milestone payments and royalties on any future sales. The Company will be solely responsible for the cost of developing antibodies to PDGF.
The Company issued a press release, dated May 3, 2013, concerning these agreements. 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 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| 99.1 | Press Release dated May 3, 2013. |
SIGNATURES
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 hereunto duly authorized.
| Date: May 6, 2013 | REGENERON PHARMACEUTICALS, INC. | |||||
| By: | /s/ Joseph J. LaRosa | |||||
| Name: | Joseph J. LaRosa | |||||
| Title: | Senior Vice President, General Counsel and Secretary | |||||
Exhibit Index
| Number |
Description | |
| 99.1 | Press Release dated May 3, 2013. | |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Press Release
Regeneron Acquires Full Rights to Two Novel Ophthalmology Development Programs
Tarrytown, New York (May 3, 2013) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it has expanded its ophthalmology portfolio by acquiring full exclusive rights to two families of novel antibodies invented at Regeneron and previously included in Regeneron’s antibody collaboration with Sanofi. Regeneron acquired full rights to antibodies targeting the PDGF (platelet derived growth factor) family of receptors and ligands in ophthalmology and all other indications and to antibodies targeting the ANG2 (angiopoietin2) receptor and ligand in ophthalmology. Antibodies to PDGF and ANG2 are currently in preclinical development for use in ophthalmology.
With respect to PDGF antibodies, Regeneron will pay Sanofi $10 million upfront, up to $40 million in development milestone payments, and royalties on sales. With respect to ANG2 antibodies in ophthalmology, Regeneron will pay Sanofi $10 million upfront, a potential $5 million development milestone payment, and royalties on sales.
Antibodies to ANG2 outside of ophthalmology will continue to be developed by Regeneron and Sanofi under their antibody collaboration agreement, including REGN910 (SAR 307746), an antibody to ANG2 that is currently in Phase 1 development in patients with advanced malignancies.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.
Regeneron Forward-Looking Statement
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s products, product candidates, and research and clinical programs now underway or planned, including without limitation antibodies targeting ANG2 and PDGF; unforeseen safety issues resulting from the administration of products and product candidates in patients; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates; competing drugs and product candidates that may be superior to Regeneron’s
products and product candidates; uncertainty of market acceptance of Regeneron’s products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron’s agreements with Sanofi and Bayer HealthCare, to be canceled or terminated without any further product success; and risks associated with third party intellectual property and pending or future litigation relating thereto. 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, including its Form 10-K for the year ended December 31, 2012. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise, unless required by law.
###
Contact Information:
| Manisha Narasimhan, Ph.D. | Peter Dworkin | |
| Investor Relations | Corporate Communications | |
| 914.847.5126 | 914.847.7640 | |
| manisha.narasimhan@regeneron.com | peter.dworkin@regeneron.com |