FORM 10-K
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(Mark One)
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(X)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended
December 31, 2015
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OR
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( )
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from __________ to __________
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Commission File Number: 0-19034
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New York
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13-3444607
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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777 Old Saw Mill River Road, Tarrytown, New York
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10591-6707
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common Stock - par value $.001 per share
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NASDAQ Global Select Market
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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
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Yes
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a
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No
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Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.
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Yes
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No
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a
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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.
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Yes
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a
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No
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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).
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Yes
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a
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No
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§232.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this form 10-K.
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a
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
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Yes
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No
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a
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Class of Common Stock
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Number of Shares
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Class A Stock, $.001 par value
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1,913,776
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Common Stock, $.001 par value
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102,874,369
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Page Numbers
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"ARCALYST
®
", "EYLEA
®
", "ZALTRAP
®
", "
VelocImmune
®
", "
VelociGene
®
", "
VelociMouse
®
", "
VelociMab
®
", and "
VelociSuite
®
" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners.
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•
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EYLEA (aflibercept) Injection, which is approved by the U.S. Food and Drug Administration (FDA) for use in retinal indications, delivered net sales growth of 54% over 2014, and is now the market-leading, branded anti-VEGF therapy in the United States.
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We, along with our partner Sanofi, received regulatory approval in the United States and Europe for Praluent (alirocumab) Injection for the treatment of uncontrolled LDL-cholesterol in certain patients. Praluent has been launched in the United States and certain European countries.
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We reported positive data from three Phase 3 studies of sarilumab in rheumatoid arthritis and submitted a regulatory application to the FDA.
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We reported positive, pivotal, Phase 2b data for dupilumab in the asthma indication and completed enrollment of three Phase 3 studies of dupilumab in atopic dermatitis.
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Two of our antibodies advanced to Phase 3 studies: REGN 2222 for the prevention of Respiratory Syncytial Virus (RSV) infection in infants; and fasinumab, an antibody against nerve growth factor (NGF), for osteoarthritis pain.
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We entered into significant new research and development collaborations: a collaboration with Mitsubishi Tanabe Pharma Corporation for fasinumab in certain Asian countries and a broad immuno-oncology collaboration with Sanofi.
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Our initiatives in genomics also advanced, enabling us to sequence exomes at the rate of 100,000 per year.
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From a company growth perspective, we hired our 4,000
th
employee, expanded into two new buildings on our Tarrytown, New York campus, continued to expand our bulk drug product manufacturing operations in Rensselaer, New York, and continued building out and hiring people for our new Limerick, Ireland commercial manufacturing facility.
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We were named one of the two top employers in the global biopharmaceutical industry by
Science
, for the fifth consecutive year.
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EYLEA (aflibercept) Injection
, known in the scientific literature as VEGF Trap-Eye, is available in the United States, European Union (EU), Japan, and certain other countries outside the United States for the treatment of neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO). EYLEA is also available in Japan and the EU for the treatment of myopic choroidal neovascularization (mCNV) and in the United States for the treatment of diabetic retinopathy in patients with DME. Bayer HealthCare has additional regulatory applications for EYLEA for various indications pending in other countries. We are collaborating with Bayer HealthCare on the global development and commercialization of EYLEA outside the United States.
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Praluent (alirocumab) Injection
, which is available in the United States where it is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol. In September 2015, the European Commission granted marketing authorization of Praluent for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia (HeFH) and non-familial) or mixed dyslipidemia as an adjunct to diet: (a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated dose of a statin, or (b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. We are collaborating with Sanofi on the global development and commercialization of Praluent.
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ARCALYST
®
(rilonacept) Injection for Subcutaneous Use
, which is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children 12 years and older.
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Trap-based Clinical Programs
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EYLEA
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In Phase 3 clinical development for the treatment of Neovascular Glaucoma (NVG) (in Japan) in collaboration with Bayer HealthCare. As described below, aflibercept is also being studied in combination with (i) an antibody to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta), and (ii) an antibody to angiopoietin-2 (Ang2).
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Antibody-based Clinical Programs in Collaboration with Sanofi
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Praluent
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Antibody to PCSK9. In Phase 3 clinical development for LDL cholesterol reduction and for the prevention of cardiovascular events. In July 2015, the FDA approved Praluent as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical ASCVD, who require additional lowering of LDL cholesterol. In September 2015, the European Commission granted marketing authorization for Praluent for the treatment of LDL cholesterol in certain adult patients with hypercholesterolemia. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
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Sarilumab (REGN88)
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Antibody to the interleukin-6 receptor (IL-6R). In clinical development in rheumatoid arthritis (Phase 3) and non-infectious uveitis (Phase 2).
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Dupilumab (REGN668)
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Antibody to the interleukin-4 receptor (IL-4R) alpha subunit. In clinical development in atopic dermatitis in adults (Phase 3), atopic dermatitis in pediatric patients (Phase 2), asthma (Phase 3), nasal polyps in patients who also have chronic sinusitis (NPwCS) (Phase 2), and eosinophilic esophagitis (EoE) (Phase 2).
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REGN2810
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Antibody to programmed cell death protein 1 (PD-1). Phase 1 clinical study in advanced malignancies initiated in the first quarter of 2015.
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Antibody-based Clinical Program in Collaboration with Bayer HealthCare
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REGN2176-3
**
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Combination product comprised of an antibody to PDGFR-beta co-formulated with aflibercept for intravitreal injection for use in ophthalmology. Phase 2 clinical study for the treatment of wet AMD initiated in the second quarter of 2015. Fast Track designation received from the FDA for the treatment of patients with wet AMD.
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Antibody-based Clinical Program in Collaboration with Mitsubishi Tanabe Pharma
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Fasinumab (REGN475)
*
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Antibody to Nerve Growth Factor (NGF). Phase 2b/3 study (16-weeks) in pain due to osteoarthritis initiated in the second quarter of 2015.
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Antibody-based Clinical Programs Developing Independently
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REGN2222
*
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Antibody to the Respiratory Syncytial Virus-F (RSV-F) protein. Phase 3 clinical study in RSV initiated in the second quarter of 2015.
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Evinacumab (REGN1500)
*
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Antibody to Angptl-3. Phase 2 clinical study for the treatment of dyslipidemia in homozygous familial hypercholesterolemia initiated in the first quarter of 2015. Partial clinical hold that excluded women of childbearing potential was lifted by the FDA in the third quarter of 2015.
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REGN1033
*
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Antibody to myostatin (GDF8). Phase 2 monotherapy clinical development in skeletal muscle disorders completed. Combination therapy plans are in development. In the second quarter of 2015, Sanofi provided notice to Regeneron that it had elected not to continue co-development of REGN1033.
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REGN1908-1909
*
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Antibody to Feld1 in Phase 1/Phase 2 clinical development against allergic disease.
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REGN1979
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Bispecific antibody against CD20 and CD3. In Phase 1 clinical development for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia.
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Nesvacumab/aflibercept (REGN910-3)
**
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Combination product comprised of an antibody to Ang2 co-formulated with aflibercept for intravitreal injection for use in ophthalmology. Phase 1 clinical development for the treatment of wet AMD and DME completed.
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*
Sanofi did not opt-in to or elected not to continue to co-develop the product candidate. Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate.
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**
Antibodies targeting the PDGF family of receptors and ligands in ophthalmology and all other indications, and antibodies targeting the Ang2 receptor and ligand in ophthalmology were previously included in our antibody collaboration with Sanofi. Under the terms of our agreements, Sanofi is entitled to receive potential development milestones and royalties on any future sales of the product candidate.
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Completed Safety Studies
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Study
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Patient group
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Primary endpoint
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Study met primary endpoint?
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ASCERTAIN
(n=202)
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Moderate to severe active RA with inadequate response to, or intolerant of, one or more TNF-alpha inhibitors
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Assess safety of two subcutaneous doses of sarilumab and tocilizumab in combination with DMARDs
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Yes
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EASY
(n=217)
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Completed patients from MOBILITY, TARGET, or ASCERTAIN trials
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Product technical failures
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Yes
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12% to 33% of dupilumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, compared to 2% with placebo (p=0.02 to p<0.0001).
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Dupilumab-treated patients experienced a 16.5% to 47% mean reduction in itching, as measured by the pruritus numerical-rating scale (NRS) score, compared to an increase of 5% in the placebo group (p=0.0005 to p<0.0001).
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Competitor
Product/Product
Candidate
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Commercial or
Development
Status
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Competitor
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Indication
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Territory
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Lucentis
®
(ranibizumab)
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Approved
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Novartis/Genentech
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Wet AMD, DME, macular edema following RVO, choroidal neovascularization secondary to pathologic myopia, diabetic retinopathy in patients with DME, and other eye indications
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Worldwide
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Avastin
®
(bevacizumab)
(off-label)
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Used to treat wet AMD, DME, and macular edema following RVO
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Roche/Genentech
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Wet AMD, DME, and macular edema following RVO
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Worldwide
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Ozurdex
®
(dexamethasone intravitreal implant)
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Approved
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Allergan
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DME, RVO
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Worldwide
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Iluvien
®
(fluocinolone acetonide intravitreal implant)
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Approved
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Alimera Sciences
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DME
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United States, EU
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Conbercept
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Approved in China for wet AMD
In development for other eye indications
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Chengdu Kanghong Pharmaceutical Group
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Wet AMD
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China
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Fovista
®
, an aptamer directed against PDGF-B
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In development (Phase 3 trials initiated in 2013 evaluating multiple combinations of Fovista, including Lucentis + Fovista, Avastin + Fovista, and EYLEA + Fovista
)
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Ophthotech Corporation (in collaboration with Roche/Genentech and Novartis)
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Wet AMD
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—
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RTH258 (ESBA1008), a single chain antibody fragment directed against VEGF-A
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In development (non-inferiority Phase 3 trial initiated in 2014 comparing RTH258 and EYLEA)
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Novartis
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Wet AMD
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—
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Abicipar pegol (anti-VEGF-A-DARPin
®
)
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In development (non-inferiority Phase 3 trial initiated in 2015 comparing dosing regimens of abicipar pegol and Lucentis)
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Allergan
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Wet AMD and related conditions
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—
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Bi-specific antibody
RG7716
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In development (Phase 2)
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Roche/Genentech
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Wet AMD
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—
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Lucentis
Port Delivery System
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In development (Phase 2)
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Roche/Genentech
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Wet AMD and related conditions
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—
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PF582, a biosimilar to Lucentis
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In development (Phase 1/2)
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Pfenex Inc. (in collaboration with Pfizer)
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Wet AMD and related conditions
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—
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FYB201, a biosimilar to Lucentis
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In development (Phase 3)
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Formycon AG (in collaboration with Bioeq GmbH)
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Wet AMD and related conditions
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—
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LMG324
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In development (Phase 1/2)
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Novartis
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Wet AMD and related conditions
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—
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Competitor Product/Product Candidate
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Commercial or
Development
Status
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Competitor
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Indication/Target
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Territory
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Repatha
TM
(evolocumab)
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Approved
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Amgen
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PCSK9 inhibitor antibody; adjunct to diet and (i) maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C or (ii) other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C
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United States, Canada, EU, Japan
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Bococizumab (RN316 / PF-04950615)
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In development (Phase 3)
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Pfizer
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Antibody against PCSK9
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—
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LY3015014
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In development (Phase 2)
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Eli Lilly
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Antibody against PCSK9
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—
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ALN-PCSsc
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In development (Phase 2)
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Alnylam Pharmaceuticals, Inc. (in collaboration with The Medicines Company)
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RNAi molecule against PCSK9 (injectable, small molecule)
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—
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Anacetrapib
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In development (Phase 3)
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Merck
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CETP-inhibitor (oral, small molecule)
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—
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AMG-899 (TA-8995)
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In development (Phase 2)
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Amgen
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CETP Inhibitor (oral, small molecule)
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—
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ETC-1002 (bempedoic acid)
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In development (Phase 2)
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Esperion Therapeutics, Inc.
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ACL-inhibitor
(oral, small molecule)
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—
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CAT-2054
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In development (Phase 2)
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Catabasis Pharmaceuticals, Inc.
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SREBP modulator (oral, small molecule)
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—
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Regeneron Antibody
Program
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Competitor
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Competitor
Product/Product
Candidate
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Commercial or
Development
Status
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Target
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Sarilumab (Phase 3)
Target: IL-6R
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Roche
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Actemra
®
(Tocilizumab)
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Approved
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Antibody against IL-6R for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis
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Johnson & Johnson (in collaboration with GlaxoSmithKline)
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Sirukumab
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In development (Phase 3)
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Antibody against IL-6
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Alder Biopharmaceuticals, Inc.
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Clazakizumab
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In development (Phase 2)
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Antibody against IL-6
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Ablynx (in collaboration with AbbVie)
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ALX-0061
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In development (Phase 2)
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Antibody against IL-6R
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R-Pharm
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Olokizumab
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In development (Phase 2)
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Antibody against IL-6
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Pfizer
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PF-04236921
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In development (Phase 1/Phase 2)
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Antibody against IL-6
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Roche
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SA 237
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In development (Phase 1/Phase 3)
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Antibody against IL-6R
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RuYi
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Gerilimzumab
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In development (Phase 1)
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Antibody against IL-6
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Dupilumab (Phase 2/Phase 3)
Target: IL-4R
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GlaxoSmithKline
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Nucala
®
(mepolizumab)
|
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Approved
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Antibody against IL-5
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Teva
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Reslizumab
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Submitted for regulatory approval
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Antibody against IL-5
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Roche
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Lebrikizumab
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In development (Phase 3)
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Antibody against IL-13
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AstraZeneca
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Benralizumab
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In development (Phase 3)
|
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Antibody against IL-5R
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AstraZeneca
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Tralokinumab
|
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In development (Phase 3)
|
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Antibody against IL-13
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Novartis
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QBX258
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In development (Phase 2)
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Fixed dose combination of antibodies against IL-4 and IL-13
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Amgen
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AMG-157
|
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In development (Phase 2)
|
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Antibody against TSLP
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Fasinumab (Phase 2b/ Phase 3)
Target: NGF
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Pfizer/Eli Lilly
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Tanezumab
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In development (Phase 3)
|
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Antibody against NGF
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Johnson & Johnson
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Fulranumab
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In development (Phase 3)
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Antibody against NGF
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REGN2222 (Phase 3)
Target: RSV-F
|
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AstraZeneca
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Synagis
®
(palivizumab)
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Approved
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Antibody against RSV-F protein
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AstraZeneca/AIMM Therapeutics
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MEDI8897
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In development (Phase 2)
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Antibody against RSV-F protein
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•
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effectiveness of the commercial strategy in and outside the United States for the marketing of EYLEA, including pricing strategy and the continued effectiveness of efforts to obtain, and the timing of obtaining, adequate third-party reimbursements;
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•
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maintaining and successfully monitoring commercial manufacturing arrangements for EYLEA with third parties who perform fill/finish or other steps in the manufacture of EYLEA to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor pharmaceutical manufacturing facilities;
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•
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our ability to meet the demand for commercial supplies of EYLEA;
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•
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our ability to effectively communicate to the marketplace the benefits of the dosing regimen of EYLEA as compared to the dosing regimen of Lucentis, and the willingness of retinal specialists and patients to switch from Lucentis or off-label use of repackaged Avastin to EYLEA or to start treatment with EYLEA;
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•
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the ability of patients, retinal specialists, and other providers to obtain and maintain sufficient coverage and reimbursement from third-party payers, including Medicare and Medicaid in the United States and other government and private payers in the United States and foreign jurisdictions;
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our ability to maintain sales of EYLEA in the face of competitive products, including those currently in clinical development; and
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the effect of existing and new health care laws and regulations currently being considered or implemented in the United States, including reporting and disclosure requirements of such laws and regulations and the potential impact of such requirements on physician prescription practices.
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effectiveness of the commercial strategy in and outside the United States for the marketing of Praluent, including pricing strategy and the effectiveness of efforts to obtain, and the timing of obtaining, adequate third-party reimbursements;
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our and Sanofi's ability to effectively communicate to the marketplace the benefits of Praluent;
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•
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the ability of patients and providers to obtain and maintain sufficient coverage and reimbursement from third-party payers, including Medicare and Medicaid in the United States and other government and private payers in the United States and foreign jurisdictions;
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our and Sanofi's ability to maintain sales of Praluent in the face of competitive products, including Amgen's Repatha, as well as product candidates currently in clinical development;
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the results of post-approval studies of Praluent (including the ongoing ODYSSEY OUTCOMES trial prospectively assessing the potential of Praluent to demonstrate cardiovascular benefit), whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and other data about Praluent (or data about products similar to Praluent that implicate an entire class of products or are perceived to do so);
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•
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our ability to meet the demand for commercial supplies of Praluent;
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•
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the effect of existing and new health care laws and regulations currently being considered or implemented in the United States, including reporting and disclosure requirements of such laws and regulations and the potential impact of such requirements on physician prescription practices; and
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•
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maintaining and successfully monitoring commercial manufacturing arrangements for Praluent with third parties who perform fill/finish or other steps in the manufacture of Praluent to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor pharmaceutical manufacturing facilities.
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•
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changes in the FDA and foreign regulatory processes for new therapeutics that may delay or prevent the approval of any of our current or future product candidates;
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•
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new laws, regulations, or judicial decisions related to healthcare availability or the payment for healthcare products and services, including prescription drugs, that would make it more difficult for us to market and sell products once they are approved by the FDA or foreign regulatory agencies;
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changes in FDA and foreign regulations that may require additional safety monitoring prior to or after the introduction of new products to market, which could materially increase our costs of doing business; and
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changes in FDA and foreign cGMPs that may make it more difficult and costly for us to maintain regulatory compliance and/or manufacture our marketed product and product candidates in accordance with cGMPs.
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•
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unfamiliar foreign laws or regulatory requirements or unexpected changes to those laws or requirements;
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•
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other laws and regulatory requirements to which our business activities abroad are subject, such as the FCPA and the U.K. Bribery Act (discussed in greater detail above under "
Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition
");
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•
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changes in the political or economic condition of a specific country or region;
|
•
|
fluctuations in the value of foreign currency versus the U.S. dollar;
|
•
|
our ability to deploy overseas funds in an efficient manner;
|
•
|
tariffs, trade protection measures, import or export licensing requirements, trade embargoes and sanctions (including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury), and other trade barriers;
|
•
|
difficulties in attracting and retaining qualified personnel; and
|
•
|
cultural differences in the conduct of business.
|
•
|
fluctuations in our operating results, in particular net product sales of EYLEA;
|
•
|
if any of our product candidates or our new indications for our marketed products receive regulatory approval, net product sales of, and profits from, these product candidates and new indications;
|
•
|
market acceptance of, and fluctuations in market share for, our marketed products, especially EYLEA and Praluent;
|
•
|
whether our net products sales and net profits underperform, meet, or exceed the expectations of investors or analysts;
|
•
|
announcement of actions by the FDA or foreign regulatory authorities or their respective advisory committees regarding our, or our collaborators', or our competitors', currently pending or future application(s) for regulatory approval of product candidate(s) or new indications for marketed products;
|
•
|
announcement of submission of an application for regulatory approval of one or more of our, or our competitors', product candidates or new indications for marketed products;
|
•
|
progress, delays, or results in clinical trials of our or our competitors' product candidates or new indications for marketed products;
|
•
|
announcement of technological innovations or product candidates by us or competitors;
|
•
|
claims by others that our products or technologies infringe their patents;
|
•
|
challenges by others to our patents in the European Patent Office and in the U.S. Patent and Trademark Office;
|
•
|
public concern as to the safety or effectiveness of any of our marketed products or product candidates or new indications for our marketed products;
|
•
|
pricing or reimbursement actions, decisions, or recommendations by government authorities, insurers, or other organizations (such as health maintenance organizations and pharmacy benefit management companies) affecting the coverage, reimbursement, or use of any of our marketed products or competitors' products;
|
•
|
our ability to raise additional capital as needed on favorable terms;
|
•
|
developments in our relationships with collaborators or key customers;
|
•
|
developments in the biotechnology industry or in government regulation of healthcare, including those relating to compounding;
|
•
|
large sales of our Common Stock by our executive officers, directors, or significant shareholders;
|
•
|
changes in tax rates, laws, or interpretation of tax laws;
|
•
|
arrivals and departures of key personnel;
|
•
|
general market conditions;
|
•
|
other factors identified in these "Risk Factors"; and
|
•
|
the perception by the investment community or our shareholders of any of the foregoing factors.
|
•
|
our current executive officers and directors beneficially owned 10.5% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options held by such persons which are exercisable within 60 days of December 31, 2015, and 21.8% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by such persons which are exercisable within 60 days of December 31, 2015; and
|
•
|
our five largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately 46.4% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of December 31, 2015. In addition, these five shareholders plus our Chief Executive Officer held approximately 52.4% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of December 31, 2015.
|
•
|
authorization to issue "blank check" preferred stock, which is preferred stock that can be created and issued by the board of directors without prior shareholder approval, with rights senior to those of our Common Stock and Class A Stock;
|
•
|
a staggered board of directors, so that it would take three successive annual meetings to replace all of our directors;
|
•
|
a requirement that removal of directors may only be effected for cause and only upon the affirmative vote of at least eighty percent (80%) of the outstanding shares entitled to vote for directors, as well as a requirement that any vacancy on the board of directors may be filled only by the remaining directors;
|
•
|
a provision whereby any action required or permitted to be taken at any meeting of shareholders may be taken without a meeting, only if, prior to such action, all of our shareholders consent, the effect of which is to require that shareholder action may only be taken at a duly convened meeting;
|
•
|
a requirement that any shareholder seeking to bring business before an annual meeting of shareholders must provide timely notice of this intention in writing and meet various other requirements; and
|
•
|
under the New York Business Corporation Law, in addition to certain restrictions which may apply to "business combinations" involving our company and an "interested shareholder," a plan of merger or consolidation of our company must be approved by two-thirds of the votes of all outstanding shares entitled to vote thereon. See the risk factor above captioned "
Our existing shareholders may be able to exert significant influence over matters requiring shareholder approval and over our management.
"
|
|
|
High
|
|
Low
|
||||
2014
|
|
|
|
|
||||
First Quarter
|
|
$
|
352.49
|
|
|
$
|
262.97
|
|
Second Quarter
|
|
320.00
|
|
|
269.50
|
|
||
Third Quarter
|
|
369.31
|
|
|
285.06
|
|
||
Fourth Quarter
|
|
437.64
|
|
|
320.06
|
|
||
|
|
|
|
|
||||
2015
|
|
|
|
|
||||
First Quarter
|
|
$
|
495.50
|
|
|
$
|
393.00
|
|
Second Quarter
|
|
544.00
|
|
|
433.47
|
|
||
Third Quarter
|
|
605.93
|
|
|
435.52
|
|
||
Fourth Quarter
|
|
592.59
|
|
|
448.10
|
|
|
12/31/2010
|
|
12/31/2011
|
|
12/31/2012
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
||||||||||||
Regeneron
|
$
|
100.00
|
|
|
$
|
168.84
|
|
|
$
|
521.08
|
|
|
$
|
838.38
|
|
|
$
|
1,249.62
|
|
|
$
|
1,653.58
|
|
S&P 500
|
100.00
|
|
|
100.00
|
|
|
113.40
|
|
|
146.97
|
|
|
163.71
|
|
|
162.52
|
|
||||||
NQ US Pharma TR Index
|
100.00
|
|
|
117.48
|
|
|
134.31
|
|
|
182.23
|
|
|
221.99
|
|
|
234.05
|
|
Period
|
|
Total Number of Shares (or Units) Purchased
|
|
Average Price Paid per Share (or Unit)
|
|
Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs
|
|
Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs
|
|||||
|
|
|
|
|
|
|
|
|
|||||
12/1/2015-12/31/2015
|
|
5,327
|
|
|
$
|
544.35
|
|
|
—
|
|
|
—
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||
(In thousands, except per share data)
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
|
$
|
2,689,478
|
|
|
$
|
1,750,762
|
|
|
$
|
1,425,839
|
|
|
$
|
858,093
|
|
|
$
|
44,686
|
|
Collaboration revenue
|
|
1,339,361
|
|
|
1,036,854
|
|
|
650,400
|
|
|
493,913
|
|
|
369,681
|
|
|||||
Other revenue
|
|
74,889
|
|
|
31,941
|
|
|
28,506
|
|
|
26,471
|
|
|
31,457
|
|
|||||
|
|
4,103,728
|
|
|
2,819,557
|
|
|
2,104,745
|
|
|
1,378,477
|
|
|
445,824
|
|
|||||
Expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
1,620,577
|
|
|
1,271,353
|
|
|
859,947
|
|
|
625,554
|
|
|
529,506
|
|
|||||
Selling, general, and administrative
|
|
838,526
|
|
|
519,267
|
|
|
346,393
|
|
|
229,859
|
|
|
119,361
|
|
|||||
Cost of goods sold
|
|
241,702
|
|
|
129,030
|
|
|
118,048
|
|
|
83,927
|
|
|
4,216
|
|
|||||
Cost of collaboration and contract manufacturing
|
|
151,007
|
|
|
75,988
|
|
|
37,307
|
|
|
528
|
|
|
—
|
|
|||||
|
|
2,851,812
|
|
|
1,995,638
|
|
|
1,361,695
|
|
|
939,868
|
|
|
653,083
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) from operations
|
|
1,251,916
|
|
|
823,919
|
|
|
743,050
|
|
|
438,609
|
|
|
(207,259
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Other income (expense)
|
|
(26,819
|
)
|
|
(62,684
|
)
|
|
(46,668
|
)
|
|
(43,292
|
)
|
|
(17,733
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) before income taxes
|
|
1,225,097
|
|
|
761,235
|
|
|
696,382
|
|
|
395,317
|
|
|
(224,992
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income tax (expense) benefit
(1)
|
|
(589,041
|
)
|
|
(423,109
|
)
|
|
(282,644
|
)
|
|
347,081
|
|
|
1,132
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss)
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
$
|
413,738
|
|
|
$
|
742,398
|
|
|
$
|
(223,860
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss) per share - basic
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
|
$
|
4.23
|
|
|
$
|
7.84
|
|
|
$
|
(2.47
|
)
|
Net income (loss) per share - diluted
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
$
|
3.72
|
|
|
$
|
6.69
|
|
|
$
|
(2.47
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
As of December 31,
|
||||||||||||||||||
(In thousands)
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrestricted and restricted cash, cash equivalents, and marketable securities (current and non-current)
|
|
$
|
1,677,385
|
|
|
$
|
1,360,634
|
|
|
$
|
1,083,875
|
|
|
$
|
587,511
|
|
|
$
|
810,550
|
|
Total assets
|
|
5,609,132
|
|
|
3,837,672
|
|
|
2,950,130
|
|
|
2,091,723
|
|
|
1,323,583
|
|
|||||
Convertible senior notes (current and non-current)
|
|
10,802
|
|
|
146,773
|
|
|
320,315
|
|
|
296,518
|
|
|
275,019
|
|
|||||
Facility lease obligations (current and non-current)
|
|
364,708
|
|
|
312,291
|
|
|
185,197
|
|
|
160,810
|
|
|
160,514
|
|
|||||
Capital lease obligations (current and non-current)
|
|
—
|
|
|
—
|
|
|
126
|
|
|
1,309
|
|
|
2,506
|
|
|||||
Stockholders' equity
|
|
3,654,837
|
|
|
2,550,251
|
|
|
1,964,716
|
|
|
1,256,618
|
|
|
485,732
|
|
ITEM 7.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
|
2015 and 2016 Events to Date
|
|
2016 Plans
|
EYLEA
|
|
Bayer HealthCare received regulatory approval for EYLEA in certain countries for the treatment of patients with wet AMD, macular edema secondary to CRVO, and DME, and continued to pursue regulatory applications for marketing approval in additional countries
|
|
Bayer HealthCare to file for additional regulatory approvals outside the United States for various indications
|
|
|
|
Regulatory agency decisions on applications outside the United States for various indications
|
|
|
|
European Commission and Japanese MHLW approved EYLEA for the treatment of macular edema secondary to BRVO
|
|
Initiate Phase 3 study for the treatment of diabetic retinopathy in patients without DME
|
|
|
FDA approved EYLEA for the treatment of diabetic retinopathy in patients with DME
|
|
|
|
|
Initiated Phase 3 trial for NVG in Japan
|
|
|
|
|
European Commission approved EYLEA for the treatment of mCNV
|
|
|
|
|
2015 and 2016 Events to Date
|
|
2016 Plans
|
Praluent (PCSK9 Antibody)
|
|
BLA accepted for priority review in the United States
|
|
Report additional results from Phase 3 ODYSSEY trials
|
|
|
Regulatory application accepted for review by the EMA
|
|
File for additional regulatory approvals outside the United States
|
|
|
Reported positive results from ODYSSEY CHOICE I and CHOICE II trials
|
|
Regulatory agency and reimbursement authority decisions on applications outside the United States
|
|
|
ODYSSEY LONG TERM 18-month trial results published in
The New England Journal of Medicine
|
|
Prespecified early-stopping interim analyses by IDMC of ODYSSEY OUTCOMES trial
|
|
|
Reported positive results from ODYSSEY Japan trial
|
|
Submit supplemental BLA for monthly dosing regimen
|
|
|
FDA approved Praluent for the treatment of adults with heterozygous familial hypercholesterolemia or clinical ASCVD, who require additional lowering of LDL cholesterol
|
|
|
|
|
European Commission granted marketing authorization for Praluent for the treatment of LDL cholesterol in certain adult patients with hypercholesterolemia
|
|
|
|
|
Completed patient enrollment in Phase 3 ODYSSEY OUTCOMES trial
|
|
|
Sarilumab (IL-6R Antibody)
|
|
Initiated and completed patient enrollment in Phase 3 SARIL-RA-MONARCH study (head-to-head monotherapy study against adalimumab)
|
|
Continue patient enrollment in Phase 3 SARIL-RA program
|
|
|
|
Report results from Phase 3 SARIL-RA-MONARCH trial
|
|
|
|
Initiated several studies in Japan
|
|
Regulatory agency decision on application for U.S. approval
|
|
|
Reported positive results from SARIL-RA-TARGET, SARIL-RA-EASY, and SARIL-RA-ASCERTAIN trials
|
|
File for regulatory approvals outside the United States
|
|
|
Completed patient enrollment in SARIL-NIU-SATURN Phase 2 study in
non-infectious uveitis and reported top-line results
|
|
|
|
|
BLA accepted for review in the United States
|
|
|
Dupilumab (IL-4R Antibody)
|
|
Initiated Phase 2 study in EoE
|
|
Continue patient enrollment in various Phase 2 and Phase 3 studies
|
|
|
Initiated and completed enrollment for Phase 2 study in atopic dermatitis in pediatric patients
|
|
Complete patient enrollment in Phase 2 EoE and Phase 3 asthma studies
|
|
|
Initiated Phase 3 study in asthma
|
|
Report results from Phase 3 atopic dermatitis pivotal trials
|
|
|
Presented positive pivotal Phase 2b data in asthma at the American Thoracic Society 2015 International Conference
|
|
Complete rolling BLA submission for atopic dermatitis in the United States
|
|
|
Completed patient enrollment in Phase 3 atopic dermatitis pivotal trials
|
|
Initiate efficacy and safety studies in pediatric patients in both atopic dermatitis and asthma
|
|
|
FDA granted Breakthrough Therapy designation to dupilumab in atopic dermatitis
|
|
|
|
|
UK MHRA granted PIM Designation to dupilumab in atopic dermatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
Antibody-based Clinical Programs (continued):
|
|
|
||
|
|
|
|
|
|
|
2015 and 2016 Events to Date
|
|
2016 Plans
|
REGN2222 (RSV-F Antibody)
|
|
Completed Phase 1 study
|
|
Continue patient enrollment in Phase 3 NURSERY Pre-Term study
|
|
|
Initiated Phase 3 NURSERY Pre-Term study
|
|
|
|
|
Received Fast Track designation from the FDA for the prevention of serious lower respiratory tract disease caused by RSV
|
|
|
Fasinumab (NGF Antibody)
|
|
Initiated sixteen-week Phase 2b/3 study in osteoarthritis
|
|
Report results from Phase 2b/3 study in osteoarthritis
|
|
|
Completed patient enrollment in a Phase 2b/3 study in osteoarthritis
|
|
Initiate longer duration Phase 3 trial
|
Evinacumab (Angptl-3 Antibody)
|
|
Initiated Phase 2 study
|
|
Complete patient enrollment in Phase 1 and Phase 2 studies
|
|
|
Partial clinical hold lifted by the FDA
|
|
|
REGN1033 (GDF8 Antibody)
|
|
Phase 2 proof-of-concept study in elderly men and women with sarcopenia met its primary endpoint, while secondary, functional endpoints were mixed.
|
|
Develop combination therapy plans
|
|
|
Sanofi elected not to continue co-development
|
|
|
REGN1908-1909 (Feld1 Antibody)
|
|
Completed patient enrollment in Phase 1/Phase 2 study
|
|
|
REGN2176-3 (PDGFR-beta Antibody co-formulated with aflibercept)
|
|
Received Fast Track designation from the FDA for the treatment of patients with wet AMD
|
|
Continue patient enrollment in Phase 2 study
|
|
|
Initiated Phase 2 study
|
|
|
REGN1979 (CD20 and CD3 Antibody)
|
|
Continued patient enrollment in Phase 1 study
|
|
Complete patient enrollment in Phase 1 study
|
Nesvacumab/aflibercept (Ang2 Antibody co-formulated with aflibercept)
|
|
Completed patient enrollment in Phase 1 study
|
|
Initiate Phase 2 study
|
REGN2810 (PD-1 Antibody)
|
|
Initiated Phase 1 study
|
|
Continue patient enrollment in Phase 1 study
|
|
|
|
|
Initiate later-stage pivotal studies
|
•
|
it requires an assumption (or assumptions) regarding a future outcome; and
|
•
|
changes in the estimate or the use of different assumptions to prepare the estimate could have a material effect on our results of operations or financial condition.
|
(In millions)
|
Rebates &
Chargebacks
|
|
Distribution-
Related
Fees
|
|
Other Sales-
Related
Deductions
|
|
Total
|
||||||||
Balance as of December 31, 2012
|
$
|
3.0
|
|
|
$
|
15.3
|
|
|
$
|
0.5
|
|
|
$
|
18.8
|
|
Provision related to current period sales
|
25.9
|
|
|
63.0
|
|
|
1.0
|
|
|
89.9
|
|
||||
Credits/payments
|
(24.5
|
)
|
|
(58.6
|
)
|
|
(1.0
|
)
|
|
(84.1
|
)
|
||||
Balance as of December 31, 2013
|
4.4
|
|
|
19.7
|
|
|
0.5
|
|
|
24.6
|
|
||||
Provision related to current period sales
|
33.1
|
|
|
77.2
|
|
|
1.6
|
|
|
111.9
|
|
||||
Credits/payments
|
(34.4
|
)
|
|
(75.7
|
)
|
|
(1.6
|
)
|
|
(111.7
|
)
|
||||
Balance as of December 31, 2014
|
3.1
|
|
|
21.2
|
|
|
0.5
|
|
|
24.8
|
|
||||
Provision related to current period sales
|
61.1
|
|
|
122.5
|
|
|
9.6
|
|
|
193.2
|
|
||||
Credits/payments
|
(57.8
|
)
|
|
(95.3
|
)
|
|
(9.6
|
)
|
|
(162.7
|
)
|
||||
Balance as of December 31, 2015
|
$
|
6.4
|
|
|
$
|
48.4
|
|
|
$
|
0.5
|
|
|
$
|
55.3
|
|
(In millions)
|
2015
|
|
2014
|
||||
Revenues
|
$
|
4,103.7
|
|
|
$
|
2,819.6
|
|
Operating expenses
|
(2,851.8
|
)
|
|
(1,995.6
|
)
|
||
Other income (expense)
|
(26.8
|
)
|
|
(62.7
|
)
|
||
Income before income taxes
|
1,225.1
|
|
|
761.3
|
|
||
Income tax expense
|
(589.0
|
)
|
|
(423.1
|
)
|
||
Net income
|
$
|
636.1
|
|
|
$
|
338.2
|
|
|
|
|
|
||||
Net income per share - diluted
|
$
|
5.52
|
|
|
$
|
2.98
|
|
(In millions)
|
2015
|
|
2014
|
||||
Net product sales
|
$
|
2,689.5
|
|
|
$
|
1,750.8
|
|
Collaboration revenue:
|
|
|
|
||||
Sanofi
|
758.9
|
|
|
541.3
|
|
||
Bayer HealthCare
|
580.5
|
|
|
495.6
|
|
||
Total collaboration revenue
|
1,339.4
|
|
|
1,036.9
|
|
||
Other revenue
|
74.8
|
|
|
31.9
|
|
||
Total revenues
|
$
|
4,103.7
|
|
|
$
|
2,819.6
|
|
Sanofi Collaboration Revenue
|
|
Year Ended
December 31, |
||||||
(In millions)
|
|
2015
|
|
2014
|
||||
Antibody:
|
|
|
|
|
||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
735.4
|
|
|
$
|
547.8
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
157.4
|
|
|
19.5
|
|
||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(240.0
|
)
|
|
(41.4
|
)
|
||
Other
|
|
10.2
|
|
|
10.2
|
|
||
Total Antibody
|
|
663.0
|
|
|
536.1
|
|
||
Immuno-oncology:
|
|
|
|
|
||||
Reimbursement of Regeneron research and development expenses
|
|
40.0
|
|
|
—
|
|
||
Other
|
|
40.0
|
|
|
—
|
|
||
Total Immuno-oncology
|
|
80.0
|
|
|
—
|
|
||
ZALTRAP:
|
|
|
|
|
||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
—
|
|
|
(4.7
|
)
|
||
Reimbursement of Regeneron research and development expenses
|
|
0.7
|
|
|
4.8
|
|
||
Other
|
|
15.2
|
|
|
5.1
|
|
||
Total ZALTRAP
|
|
15.9
|
|
|
5.2
|
|
||
Total Sanofi collaboration revenue
|
|
$
|
758.9
|
|
|
$
|
541.3
|
|
Bayer HealthCare Collaboration Revenue
|
|
Year Ended
December 31, |
||||||
(In millions)
|
|
2015
|
|
2014
|
||||
EYLEA:
|
|
|
|
|
||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
466.7
|
|
|
$
|
301.3
|
|
Sales milestones
|
|
15.0
|
|
|
105.0
|
|
||
Cost-sharing of Regeneron EYLEA development expenses
|
|
8.9
|
|
|
23.4
|
|
||
Other
|
|
69.4
|
|
|
52.4
|
|
||
Total EYLEA
|
|
560.0
|
|
|
482.1
|
|
||
PDGFR-beta antibody:
|
|
|
|
|
||||
Cost-sharing of REGN2176-3 development expenses
|
|
10.1
|
|
|
2.9
|
|
||
Other
|
|
10.4
|
|
|
10.6
|
|
||
Total PDGFR-beta antibody
|
|
20.5
|
|
|
13.5
|
|
||
Total Bayer HealthCare collaboration revenue
|
|
$
|
580.5
|
|
|
$
|
495.6
|
|
Regeneron's Net Profit from EYLEA Sales Outside the United States
|
|
Year Ended
December 31,
|
||||||
(In millions)
|
|
2015
|
|
2014
|
||||
Net product sales outside the United States
|
|
$
|
1,413.3
|
|
|
$
|
1,038.5
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
521.8
|
|
|
358.3
|
|
||
Reimbursement of EYLEA development expenses incurred by Bayer HealthCare in accordance with Regeneron's payment obligation
|
|
(55.1
|
)
|
|
(57.0
|
)
|
||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
466.7
|
|
|
$
|
301.3
|
|
Research and Development Expenses
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2015
|
|
2014
|
|
(Decrease)
|
||||||
Payroll and benefits
(1)
|
|
$
|
506.3
|
|
|
$
|
401.6
|
|
|
$
|
104.7
|
|
Clinical trial expenses
|
|
306.1
|
|
|
203.0
|
|
|
103.1
|
|
|||
Clinical manufacturing costs
(2)
|
|
431.8
|
|
|
284.8
|
|
|
147.0
|
|
|||
Research and other development costs
|
|
133.6
|
|
|
137.2
|
|
|
(3.6
|
)
|
|||
Occupancy and other operating costs
|
|
136.4
|
|
|
116.5
|
|
|
19.9
|
|
|||
Cost-sharing of Bayer HealthCare and Sanofi development expenses
(3)
|
|
106.4
|
|
|
128.3
|
|
|
(21.9
|
)
|
|||
Total research and development expenses
|
|
$
|
1,620.6
|
|
|
$
|
1,271.4
|
|
|
$
|
349.2
|
|
Project Costs
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2015
|
|
2014
|
|
(Decrease)
|
||||||
Praluent
|
|
$
|
231.0
|
|
|
$
|
316.4
|
|
|
$
|
(85.4
|
)
|
Dupilumab
|
|
404.0
|
|
|
169.0
|
|
|
235.0
|
|
|||
Sarilumab
|
|
84.6
|
|
|
86.1
|
|
|
(1.5
|
)
|
|||
EYLEA
|
|
75.0
|
|
|
110.4
|
|
|
(35.4
|
)
|
|||
Fasinumab
|
|
56.1
|
|
|
8.2
|
|
|
47.9
|
|
|||
REGN2222
|
|
42.6
|
|
|
16.7
|
|
|
25.9
|
|
|||
Other antibody candidates in clinical development
|
|
185.8
|
|
|
171.6
|
|
|
14.2
|
|
|||
Other research programs and unallocated costs
|
|
541.5
|
|
|
393.0
|
|
|
148.5
|
|
|||
Total research and development expenses
|
|
$
|
1,620.6
|
|
|
$
|
1,271.4
|
|
|
$
|
349.2
|
|
(In millions)
|
2014
|
|
2013
|
||||
Revenues
|
$
|
2,819.6
|
|
|
$
|
2,104.7
|
|
Operating expenses
|
(1,995.6
|
)
|
|
(1,361.7
|
)
|
||
Other income (expense)
|
(62.7
|
)
|
|
(46.6
|
)
|
||
Income before income taxes
|
761.3
|
|
|
696.4
|
|
||
Income tax expense
|
(423.1
|
)
|
|
(282.6
|
)
|
||
Net income
|
$
|
338.2
|
|
|
$
|
413.8
|
|
|
|
|
|
||||
Net income per share - diluted
|
$
|
2.98
|
|
|
$
|
3.72
|
|
(In millions)
|
2014
|
|
2013
|
||||
Net product sales
|
$
|
1,750.8
|
|
|
$
|
1,425.8
|
|
Collaboration revenue:
|
|
|
|
||||
Sanofi
|
541.3
|
|
|
430.1
|
|
||
Bayer HealthCare
|
495.6
|
|
|
220.3
|
|
||
Total collaboration revenue
|
1,036.9
|
|
|
650.4
|
|
||
Other revenue
|
31.9
|
|
|
28.5
|
|
||
Total revenue
|
$
|
2,819.6
|
|
|
$
|
2,104.7
|
|
Sanofi Collaboration Revenue
|
|
Year Ended
December 31, |
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
Antibody:
|
|
|
|
|
||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
547.8
|
|
|
$
|
453.5
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
19.5
|
|
|
1.9
|
|
||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(41.4
|
)
|
|
—
|
|
||
Up-front payments to Sanofi for acquisition of rights related to two antibodies
|
|
—
|
|
|
(20.0
|
)
|
||
Other
|
|
10.2
|
|
|
10.2
|
|
||
Total Antibody
|
|
536.1
|
|
|
445.6
|
|
||
ZALTRAP:
|
|
|
|
|
||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
(4.7
|
)
|
|
(30.8
|
)
|
||
Reimbursement of Regeneron research and development expenses
|
|
4.8
|
|
|
5.6
|
|
||
Other
|
|
5.1
|
|
|
9.7
|
|
||
Total ZALTRAP
|
|
5.2
|
|
|
(15.5
|
)
|
||
Total Sanofi collaboration revenue
|
|
$
|
541.3
|
|
|
$
|
430.1
|
|
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
Year Ended December 31,
|
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
Net product sales recorded by Sanofi
|
|
$
|
91.4
|
|
|
$
|
70.2
|
|
Regeneron's share of collaboration losses
|
|
(4.7
|
)
|
|
(30.8
|
)
|
Bayer HealthCare Collaboration Revenue
|
|
Year Ended
December 31, |
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
EYLEA:
|
|
|
|
|
||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
301.3
|
|
|
$
|
101.5
|
|
Sales and substantive development milestones
|
|
105.0
|
|
|
70.0
|
|
||
Cost-sharing of Regeneron EYLEA development expenses
|
|
23.4
|
|
|
20.9
|
|
||
Other
|
|
52.4
|
|
|
27.9
|
|
||
Total EYLEA
|
|
482.1
|
|
|
220.3
|
|
||
PDGFR-beta antibody:
|
|
|
|
|
||||
Cost-sharing of REGN2176-3 development expenses
|
|
2.9
|
|
|
—
|
|
||
Other
|
|
10.6
|
|
|
—
|
|
||
Total PDGFR-beta
|
|
13.5
|
|
|
—
|
|
||
Total Bayer HealthCare collaboration revenue
|
|
$
|
495.6
|
|
|
$
|
220.3
|
|
Regeneron's Net Profit from EYLEA Sales Outside the United States
|
|
Year Ended
December 31,
|
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
Net product sales outside the United States
|
|
$
|
1,038.5
|
|
|
$
|
472.1
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
358.3
|
|
|
159.1
|
|
||
Reimbursement of EYLEA development expenses incurred by Bayer HealthCare in accordance with Regeneron's payment obligation
|
|
(57.0
|
)
|
|
(57.6
|
)
|
||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
301.3
|
|
|
$
|
101.5
|
|
Research and Development Expenses
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Payroll and benefits
(1)
|
|
$
|
401.6
|
|
|
$
|
290.7
|
|
|
$
|
110.9
|
|
Clinical trial expenses
|
|
203.0
|
|
|
139.5
|
|
|
63.5
|
|
|||
Clinical manufacturing costs
(2)
|
|
284.8
|
|
|
237.3
|
|
|
47.5
|
|
|||
Research and other development costs
|
|
137.2
|
|
|
73.1
|
|
|
64.1
|
|
|||
Occupancy and other operating costs
|
|
116.5
|
|
|
86.4
|
|
|
30.1
|
|
|||
Cost-sharing of Bayer HealthCare and Sanofi development expenses
(3)
|
|
128.3
|
|
|
32.9
|
|
|
95.4
|
|
|||
Total research and development expenses
|
|
$
|
1,271.4
|
|
|
$
|
859.9
|
|
|
$
|
411.5
|
|
Project Costs
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
EYLEA
|
|
$
|
110.4
|
|
|
$
|
133.3
|
|
|
$
|
(22.9
|
)
|
Praluent
|
|
316.4
|
|
|
152.2
|
|
|
164.2
|
|
|||
Sarilumab
|
|
86.1
|
|
|
51.9
|
|
|
34.2
|
|
|||
Dupilumab
|
|
169.0
|
|
|
89.0
|
|
|
80.0
|
|
|||
Other antibody candidates in clinical development
|
|
196.5
|
|
|
120.3
|
|
|
76.2
|
|
|||
Other research programs and unallocated costs
|
|
393.0
|
|
|
313.2
|
|
|
79.8
|
|
|||
Total research and development expenses
|
|
$
|
1,271.4
|
|
|
$
|
859.9
|
|
|
$
|
411.5
|
|
|
|
|
|
Payments Due by Period
|
||||||||||||||||
(In millions)
|
|
Total
|
|
Less than one year
|
|
1 to 3 years
|
|
3 to 5 years
|
|
Greater than 5 years
|
||||||||||
Convertible senior notes
(1)
|
|
$
|
11.4
|
|
|
$
|
11.4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Operating leases
(2)
|
|
112.8
|
|
|
15.5
|
|
|
$
|
23.5
|
|
|
$
|
23.1
|
|
|
$
|
50.7
|
|
||
Purchase and other obligations
(3)
|
|
1,066.8
|
|
|
585.9
|
|
|
431.4
|
|
|
32.5
|
|
|
17.0
|
|
|||||
Facility lease obligations
(4)
|
|
472.4
|
|
|
31.2
|
|
|
64.6
|
|
|
67.7
|
|
|
308.9
|
|
|||||
Total contractual obligations
|
|
$
|
1,663.4
|
|
|
$
|
644.0
|
|
|
$
|
519.5
|
|
|
$
|
123.3
|
|
|
$
|
376.6
|
|
(1)
|
Consists of
$11.2 million
remaining aggregate principal amount of 1.875% convertible senior notes that mature on October 1, 2016, unless earlier converted or repurchased. The amount in the table above assumes the payment of interest on our Notes through their maturity date and the payment of the principal amount of the Notes at their maturity date. Interest on the Notes is payable semi-annually. The Notes are convertible, subject to certain conditions, into cash, shares of our Common Stock, or a combination of cash and shares of Common Stock, at our option. See Note 11 to our Consolidated Financial Statements.
|
(2)
|
Excludes future contingent costs for utilities, real estate taxes, and operating expenses. In 2015, these costs were
$15.5 million
. See Note 12(a) to our Consolidated Financial Statements.
|
(3)
|
Purchase and other obligations primarily relate to research and development commitments, including those related to clinical trials, and capital expenditures for equipment acquisitions. Our obligation to pay certain of these amounts may increase or be reduced based on certain future events. Open purchase orders for the acquisition of goods and services in the ordinary course of business are excluded from the table above.
|
(4)
|
Represents rent payments with respect to facility lease obligations in connection with our lease of certain buildings in Tarrytown, New York, as described under "Tarrytown, New York Leases" above. Rent payments on two of these buildings commenced in the second half of 2015, and were based on several factors, including the landlord's costs of construction and tenant allowances. See Note 12(a) to our Consolidated Financial Statements.
|
10.2 +
|
Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 16, 2014.)
|
10.2.1 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)
|
10.2.2 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of incentive stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)
|
10.2.3 +
|
Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)
|
10.2.4 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)
|
10.2.5 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P. Roy Vagelos, M.D. under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan.
|
10.2.6 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of incentive stock options to P. Roy Vagelos, M.D. under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan.
|
10.2.7 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)
|
10.2.8 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of incentive stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)
|
10.2.9 +
|
Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)
|
10.2.10 +
|
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised).
|
10.3 +
|
Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S. Schleifer, M.D., Ph.D. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, 2009.)
|
10.4* +
|
Employment Agreement, dated as of December 31, 1998, between the Registrant and P. Roy Vagelos, M.D. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2004, filed March 11, 2005.)
|
10.5 +
|
Offer Letter for Robert E. Landry effective September 9, 2013. (Incorporated by reference from the Form 8-K for the Registrant, filed September 12, 2013.)
|
10.6 +
|
Regeneron Pharmaceuticals, Inc. Change in Control Severance Plan, amended and restated effective as of November 14, 2008. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, 2009.)
|
10.7 +
|
Regeneron Pharmaceuticals, Inc. Cash Incentive Bonus Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 17, 2015.)
|
10.8*
|
IL-1 Antibody Termination Agreement by and between Novartis Pharma AG, Novartis Pharmaceuticals Corporation and the Registrant, dated as of June 8, 2009. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2009, filed August 4, 2009.)
|
10.9*
|
Trap-2 Termination Agreement by and between Novartis Pharma AG, Novartis Pharmaceuticals Corporation and the Registrant, dated as of June 8, 2009. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2009, filed August 4, 2009.)
|
10.10*
|
Amended and Restated Collaboration Agreement, dated as of February 23, 2015, by and between Sanofi-Aventis US LLC and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2015, filed May 7, 2015.)
|
10.11*
|
License and Collaboration Agreement, dated as of October 18, 2006, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2006, filed November 6, 2006.)
|
10.11.1*
|
Restated Amendment Agreement, dated December 30, 2014 and entered into effective as of May 7, 2012, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)
|
10.12
|
License and Collaboration Agreement, dated as of January 10, 2014, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2014, filed May 8, 2014.)
|
10.13
|
Lease, dated as of December 21, 2006, by and between BMR-Landmark at Eastview LLC and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant, filed December 22, 2006.)
|
10.13.1*
|
First Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of September 14, 2007. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2007, filed November 7, 2007.)
|
10.13.2
|
Second Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of September 30, 2008. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2008, filed November 5, 2008.)
|
10.13.3
|
Third Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of April 29, 2009. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2009, filed April 30, 2009.)
|
10.13.4
|
Fourth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of December 3, 2009. (Incorporated by reference from the Form 8-K for the Registrant, filed December 8, 2009.)
|
10.13.5
|
Fifth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of February 11, 2010. (Incorporated by reference from the Form 8-K for the Registrant, filed February 16, 2010.)
|
10.13.6
|
Sixth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 4, 2010. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2010, filed July 28, 2010.)
|
10.13.7
|
Seventh Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of December 22, 2010. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2010, filed February 17, 2011.)
|
10.13.8
|
Eighth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of August 1, 2011. (Incorporated by reference from the Form 10-Q for the Registrant for the quarter ended September 30, 2011, filed October 27, 2011.)
|
10.13.9
|
Ninth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of September 30, 2011. (Incorporated by reference from the Form 10-Q for the Registrant for the quarter ended September 30, 2011, filed October 27, 2011.)
|
10.13.10
|
Tenth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of October 25, 2012. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2015, filed August 4, 2015.)
|
10.13.11
|
Eleventh Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of April 3, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.13.12
|
Twelfth Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of May 31, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.13.13
|
Thirteenth Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of May 31, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.13.14
|
Fourteenth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of October 25, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2015, filed August 4, 2015.)
|
10.13.15
|
Fifteenth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 12, 2014. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2015, filed August 4, 2015.)
|
10.13.16
|
Sixteenth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 30, 2015. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2015, filed August 4, 2015.)
|
10.13.17
|
Seventeenth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of August 10, 2015. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
|
10.14
|
Mt. Pleasant Lease by and between BMR-Landmark at Eastview LLC and the Registrant, dated April 3, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.14.1
|
First Amendment to Mt. Pleasant Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 30, 2015. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2015, filed August 4, 2015.)
|
10.15*
|
Non Exclusive License and Material Transfer Agreement, dated as of March 30, 2007, by and between Astellas Pharma Inc. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2007, filed May 4, 2007.)
|
10.15.1*
|
Amendment to the Non Exclusive License and Material Transfer Agreement, dated as of March 30, 2007 by and between Astellas Pharma Inc. and the Registrant, dated as of July 28, 2010. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2010, filed October 28, 2010.)
|
10.16*
|
Amended and Restated Discovery and Preclinical Development Agreement, dated as of November 10, 2009, by and between Aventis Pharmaceuticals Inc. and the Registrant. (Incorporated by reference from the Form 10-K/A for the Registrant, for the year ended December 31, 2009, filed June 2, 2010.)
|
10.16.1*
|
Amendment No. 1 to Amended and Restated Discovery and Preclinical Development Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
|
10.17*
|
Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009, by and among Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form 10-K/A for the Registrant, for the year ended December 31, 2009, filed June 2, 2010.)
|
10.17.1*
|
First Amendment to Amended and Restated License and Collaboration Agreement by and between the Registrant and Aventis Pharmaceuticals Inc., dated May 1, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.17.2*
|
Amendment No. 2 to Amended and Restated License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
|
10.18
|
Amended and Restated Investor Agreement, dated as of January 11, 2014, by and among Sanofi, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant, filed January 13, 2014.)
|
10.19*
|
Amended and Restated Non-Exclusive License Agreement, dated as of July 1, 2008 by and between Cellectis, S.A. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2008, filed August 1, 2008.)
|
10.20
|
Purchase Agreement, dated as of October 18, 2011, between the Registrant and Goldman, Sachs & Co. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.21
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.22
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.22.1
|
Amendment, dated as of May 15, 2014, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.)
|
10.22.2
|
Second Amendment, dated as of November 25, 2014, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)
|
10.22.3
|
Third Amendment, dated as of February 27, 2015, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2015, filed May 7, 2015.)
|
10.23
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.24
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.24.1
|
Amendment, dated as of May 13, 2014, to the Master Terms and Conditions for Warrants, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.)
|
10.25
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Credit Suisse International and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.26
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Credit Suisse International and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.26.1
|
Amendment, dated as of May 14, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.)
|
10.26.2
|
Second Amendment, dated as of November 18, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)
|
10.26.3
|
Third Amendment, dated as of November 24, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)
|
10.26.4
|
Fourth Amendment, dated as of November 15, 2015, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant.
|
10.27
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Morgan Stanley & Co. International plc and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.28
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Morgan Stanley & Co. International plc and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)
|
10.28.1
|
Amendment, dated as of May 16, 2014, to the Master Terms and Conditions for Warrants, between Morgan Stanley & Co. International plc and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.)
|
10.28.2
|
Second Amendment, dated as of August 5, 2015, to the Master Terms and Conditions for Warrants, between Morgan Stanley & Co. International plc and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
|
10.29*
|
Non-exclusive License and Partial Settlement Agreement with Genentech, Inc. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2011, filed February 21, 2012.)
|
10.29.1*
|
Amended and Restated Non-Exclusive License and Settlement Agreement by and between Genentech, Inc. and the Registrant, effective May 17, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.29.2*
|
Non-Exclusive License and Settlement Agreement by and between Genentech, Inc., the Registrant, Sanofi U.S. Services, Inc., and Sanofi-Aventis U.S. LLC, effective May 17, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.29.3
|
Agreement dated May 17, 2013 between Bayer Pharma AG, Bayer Australia Limited, the Registrant, Regeneron UK Ltd and Genentech Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.30*
|
Letter Agreement by and between the Registrant and Aventis Pharmaceuticals Inc., dated May 2, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)
|
10.31
|
Credit Agreement, dated as of March 19, 2015, by and among the Registrant, as a borrower and guarantor; certain direct and indirect subsidiaries of the Registrant, as the initial subsidiary borrowers; JPMorgan Chase Bank, N.A., as administrative agent; Bank of America, N.A. and U.S. Bank National Association, as co-syndication agents; Barclays Bank PLC, Citibank, N.A., Credit Suisse AG, Cayman Islands Branch, Fifth Third Bank and Morgan Stanley MUFG Loan Partners, LLC, as co-documentation agents; JPMorgan Chase Bank, N.A., Bank of America, N.A. and U.S. Bank National Association, as the issuing banks; JPMorgan Chase Bank, N.A., as the swingline lender; and the other lenders party thereto from time to time. (Incorporated by reference from the Form 8-K for the Registrant, filed March 23, 2015.)
|
10.32*
|
Immuno-oncology Discovery and Development Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
|
10.33*
|
Immuno-oncology License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
|
10.34*
|
Collaboration Agreement, dated as of September 29, 2015, by and between Regeneron Ireland and Mitsubishi Tanabe Pharma Corporation. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
|
21.1
|
Subsidiaries of the Registrant.
|
23.1
|
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
|
24.1
|
Power of Attorney (included on the signature page of this Annual Report on Form 10-K).
|
31.1
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
31.2
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
32
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
|
101
|
Interactive Data File
|
101.INS
|
XBRL Instance Document
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase
|
101.DEF
|
XBRL Taxonomy Extension Definition Document
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase
|
_______
|
|
|
|
|
*
|
|
Portions of this document have been omitted and filed separately with the Commission pursuant to requests for confidential treatment pursuant to Rule 24b-2.
|
+
|
|
Indicates a management contract or compensatory plan or arrangement.
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
Date:
|
February 11, 2016
|
|
By:
|
/s/ LEONARD S. SCHLEIFER
|
|
|
|
|
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
/s/ LEONARD S. SCHLEIFER
|
|
President, Chief Executive Officer, and Director (Principal Executive Officer)
|
|
February 11, 2016
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
/s/ ROBERT E. LANDRY
|
|
Senior Vice President, Finance and Chief Financial Officer (Principal Financial Officer)
|
|
February 11, 2016
|
Robert E. Landry
|
|
|
|
|
/s/ DOUGLAS S. McCORKLE
|
|
Vice President, Controller, and Assistant Treasurer (Principal Accounting Officer)
|
|
February 11, 2016
|
Douglas S. McCorkle
|
|
|
|
|
/s/ GEORGE D. YANCOPOULOS
|
|
Chief Scientific Officer, President, Regeneron Laboratories, and Director
|
|
February 11, 2016
|
George D. Yancopoulos, M.D., Ph.D.
|
|
|
|
|
/s/ P. ROY VAGELOS
|
|
Chairman of the Board
|
|
February 11, 2016
|
P. Roy Vagelos, M.D.
|
|
|
|
|
/s/ CHARLES A. BAKER
|
|
Director
|
|
February 11, 2016
|
Charles A. Baker
|
|
|
|
|
/s/ MICHAEL S. BROWN
|
|
Director
|
|
February 11, 2016
|
Michael S. Brown, M.D.
|
|
|
|
|
/s/ JOSEPH L. GOLDSTEIN
|
|
Director
|
|
February 11, 2016
|
Joseph L. Goldstein, M.D.
|
|
|
|
|
/s/ CHRISTINE A. POON
|
|
Director
|
|
February 11, 2016
|
Christine A. Poon
|
|
|
|
|
/s/ ARTHUR F. RYAN
|
|
Director
|
|
February 11, 2016
|
Arthur F. Ryan
|
|
|
|
|
/s/ GEORGE L. SING
|
|
Director
|
|
February 11, 2016
|
George L. Sing
|
|
|
|
|
/s/ MARC TESSIER-LAVIGNE
|
|
Director
|
|
February 11, 2016
|
Marc Tessier-Lavigne, Ph.D.
|
|
|
|
|
|
|
Page Numbers
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
809,102
|
|
|
$
|
648,719
|
|
Marketable securities
|
236,121
|
|
|
251,761
|
|
||
Accounts receivable - trade, net
|
1,152,489
|
|
|
739,379
|
|
||
Accounts receivable from Sanofi
|
153,152
|
|
|
111,510
|
|
||
Accounts receivable from Bayer HealthCare
|
162,152
|
|
|
125,483
|
|
||
Inventories
|
238,578
|
|
|
128,861
|
|
||
Prepaid expenses and other current assets
|
163,501
|
|
|
79,046
|
|
||
Total current assets
|
2,915,095
|
|
|
2,084,759
|
|
||
|
|
|
|
||||
Marketable securities
|
632,162
|
|
|
460,154
|
|
||
Property, plant, and equipment, at cost, net of accumulated depreciation and amortization
|
1,594,120
|
|
|
974,309
|
|
||
Deferred tax assets
|
461,945
|
|
|
315,416
|
|
||
Other assets
|
5,810
|
|
|
3,034
|
|
||
Total assets
|
$
|
5,609,132
|
|
|
$
|
3,837,672
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
644,112
|
|
|
$
|
483,489
|
|
Deferred revenue from Sanofi, current portion
|
101,573
|
|
|
15,927
|
|
||
Deferred revenue - other, current portion
|
51,914
|
|
|
58,098
|
|
||
Other current liabilities
|
13,563
|
|
|
97,146
|
|
||
Total current liabilities
|
811,162
|
|
|
654,660
|
|
||
|
|
|
|
||||
Deferred revenue from Sanofi
|
582,664
|
|
|
62,819
|
|
||
Deferred revenue - other
|
82,015
|
|
|
72,430
|
|
||
Facility lease obligations
|
362,919
|
|
|
310,938
|
|
||
Convertible senior notes
|
—
|
|
|
146,773
|
|
||
Other long-term liabilities
|
115,535
|
|
|
39,801
|
|
||
Total liabilities
|
1,954,295
|
|
|
1,287,421
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 12)
|
|
|
|
||||
|
|
|
|
||||
Stockholders' equity:
|
|
|
|
||||
Preferred stock, $.01 par value; 30,000,000 shares authorized; issued and outstanding - none
|
—
|
|
|
—
|
|
||
Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized; shares issued and outstanding - 1,913,776 in 2015 and 1,973,368 in 2014
|
2
|
|
|
2
|
|
||
Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - 106,378,001 in 2015 and 102,475,154 in 2014
|
106
|
|
|
102
|
|
||
Additional paid-in capital
|
3,099,526
|
|
|
2,450,782
|
|
||
Retained earnings
|
852,700
|
|
|
216,644
|
|
||
Accumulated other comprehensive income
|
8,572
|
|
|
52,251
|
|
||
Treasury stock, at cost; 3,642,820 shares in 2015 and 2,017,732 in 2014
|
(306,069
|
)
|
|
(169,530
|
)
|
||
Total stockholders' equity
|
3,654,837
|
|
|
2,550,251
|
|
||
Total liabilities and stockholders' equity
|
$
|
5,609,132
|
|
|
$
|
3,837,672
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Statements of Operations
|
|
|
|
|
|
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Net product sales
|
|
$
|
2,689,478
|
|
|
$
|
1,750,762
|
|
|
$
|
1,425,839
|
|
Sanofi collaboration revenue
|
|
758,873
|
|
|
541,299
|
|
|
430,111
|
|
|||
Bayer HealthCare collaboration revenue
|
|
580,488
|
|
|
495,555
|
|
|
220,289
|
|
|||
Other revenue
|
|
74,889
|
|
|
31,941
|
|
|
28,506
|
|
|||
|
|
4,103,728
|
|
|
2,819,557
|
|
|
2,104,745
|
|
|||
|
|
|
|
|
|
|
||||||
Expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
1,620,577
|
|
|
1,271,353
|
|
|
859,947
|
|
|||
Selling, general, and administrative
|
|
838,526
|
|
|
519,267
|
|
|
346,393
|
|
|||
Cost of goods sold
|
|
241,702
|
|
|
129,030
|
|
|
118,048
|
|
|||
Cost of collaboration and contract manufacturing
|
|
151,007
|
|
|
75,988
|
|
|
37,307
|
|
|||
|
|
2,851,812
|
|
|
1,995,638
|
|
|
1,361,695
|
|
|||
|
|
|
|
|
|
|
||||||
Income from operations
|
|
1,251,916
|
|
|
823,919
|
|
|
743,050
|
|
|||
|
|
|
|
|
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
||||||
Investment and other income (expense)
|
|
6,283
|
|
|
8,157
|
|
|
(231
|
)
|
|||
Interest expense
|
|
(14,241
|
)
|
|
(37,372
|
)
|
|
(46,437
|
)
|
|||
Loss on extinguishment of debt
|
|
(18,861
|
)
|
|
(33,469
|
)
|
|
—
|
|
|||
|
|
(26,819
|
)
|
|
(62,684
|
)
|
|
(46,668
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income before income taxes
|
|
1,225,097
|
|
|
761,235
|
|
|
696,382
|
|
|||
|
|
|
|
|
|
|
||||||
Income tax expense
|
|
(589,041
|
)
|
|
(423,109
|
)
|
|
(282,644
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
$
|
413,738
|
|
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
|
$
|
4.23
|
|
Net income per share - diluted
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
$
|
3.72
|
|
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
|
103,061
|
|
|
100,612
|
|
|
97,917
|
|
|||
Weighted average shares outstanding - diluted
|
|
115,230
|
|
|
113,413
|
|
|
111,290
|
|
|||
|
|
|
|
|
|
|
||||||
Statements of Comprehensive Income
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
$
|
413,738
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
||||||
Unrealized (loss) gain on marketable securities, net of tax
|
|
(43,679
|
)
|
|
53,439
|
|
|
(22
|
)
|
|||
Comprehensive income
|
|
$
|
592,377
|
|
|
$
|
391,565
|
|
|
$
|
413,716
|
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Class A Stock
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Retained Earnings (Accumulated Deficit)
|
|
Treasury Stock
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholders' Equity
|
|||||||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||
Balance, December 31, 2012
|
|
2,069
|
|
|
$
|
2
|
|
|
95,223
|
|
|
$
|
95
|
|
|
$
|
1,792,907
|
|
|
$
|
(535,220
|
)
|
|
—
|
|
|
—
|
|
|
$
|
(1,166
|
)
|
|
$
|
1,256,618
|
|
|
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
3,052
|
|
|
3
|
|
|
54,759
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
54,762
|
|
|||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(701
|
)
|
|
(1
|
)
|
|
(195,086
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(195,087
|
)
|
|||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
|
|
—
|
|
|
—
|
|
|
38
|
|
|
—
|
|
|
5,718
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,718
|
|
|||||||
Issuance of restricted Common Stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Conversion of Class A Stock to Common Stock
|
|
(49
|
)
|
|
—
|
|
|
49
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
217,080
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
217,080
|
|
|||||||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
211,909
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
211,909
|
|
|||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
413,738
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
413,738
|
|
|||||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(22
|
)
|
|
(22
|
)
|
|||||||
Balance, December 31, 2013
|
|
2,020
|
|
|
2
|
|
|
97,667
|
|
|
97
|
|
|
2,087,287
|
|
|
(121,482
|
)
|
|
—
|
|
|
—
|
|
|
(1,188
|
)
|
|
1,964,716
|
|
|||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
3,468
|
|
|
4
|
|
|
125,893
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
125,897
|
|
|||||||
Common Stock tendered upon exercise of stock options in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(754
|
)
|
|
(1
|
)
|
|
(267,583
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(267,584
|
)
|
|||||||
Issuance of Common Stock in connection with conversion of convertible senior notes
|
|
—
|
|
|
—
|
|
|
2,018
|
|
|
2
|
|
|
691,354
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
691,356
|
|
|||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
|
|
—
|
|
|
—
|
|
|
21
|
|
|
—
|
|
|
13,125
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13,125
|
|
|||||||
Issuance of restricted Common Stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Conversion of Class A Stock to Common Stock
|
|
(47
|
)
|
|
—
|
|
|
47
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
326,815
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
326,815
|
|
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (
continued
)
|
|||||||||||||||||||||||||||||||||||||
|
|
Class A Stock
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Retained Earnings (Accumulated Deficit)
|
|
Treasury Stock
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholders' Equity
|
|||||||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
439,278
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
439,278
|
|
|||||||
Acquisition of Common Stock in connection with exercise of convertible note hedges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
169,530
|
|
|
—
|
|
|
(2,018
|
)
|
|
$
|
(169,530
|
)
|
|
—
|
|
|
—
|
|
||||||
Reduction of warrants
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(294,552
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(294,552
|
)
|
|||||||
Reclassification of warrant liability
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(148,496
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(148,496
|
)
|
|||||||
Reduction of equity component of convertible senior notes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(691,869
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(691,869
|
)
|
|||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
338,126
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
338,126
|
|
|||||||
Other comprehensive income, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
53,439
|
|
|
53,439
|
|
|||||||
Balance, December 31, 2014
|
|
1,973
|
|
|
2
|
|
|
102,475
|
|
|
102
|
|
|
2,450,782
|
|
|
216,644
|
|
|
(2,018
|
)
|
|
(169,530
|
)
|
|
52,251
|
|
|
2,550,251
|
|
|||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
2,457
|
|
|
2
|
|
|
215,460
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
215,462
|
|
|||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(298
|
)
|
|
—
|
|
|
(160,538
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(160,538
|
)
|
|||||||
Issuance of Common Stock in connection with conversion of convertible senior notes
|
|
—
|
|
|
—
|
|
|
1,625
|
|
|
2
|
|
|
818,358
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
818,360
|
|
|||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
|
|
—
|
|
|
—
|
|
|
31
|
|
|
—
|
|
|
15,382
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15,382
|
|
|||||||
Issuance of restricted Common Stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
28
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Conversion of Class A Stock to Common Stock
|
|
(60
|
)
|
|
—
|
|
|
60
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
464,022
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
464,022
|
|
|||||||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
405,317
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
405,317
|
|
|||||||
Acquisition of Common Stock in connection with exercise of convertible note hedges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
136,539
|
|
|
—
|
|
|
(1,625
|
)
|
|
(136,539
|
)
|
|
—
|
|
|
—
|
|
|||||||
Reduction of warrants
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(449,456
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(449,456
|
)
|
|||||||
Reclassification of warrant liability
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
23,317
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
23,317
|
|
|||||||
Reduction of equity component of convertible senior notes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(819,657
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(819,657
|
)
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
$
|
413,738
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
74,909
|
|
|
52,686
|
|
|
41,204
|
|
|||
Non-cash compensation expense
|
|
459,049
|
|
|
321,750
|
|
|
215,377
|
|
|||
Loss on extinguishment of debt
|
|
18,861
|
|
|
33,469
|
|
|
—
|
|
|||
Other non-cash charges and expenses, net
|
|
33,701
|
|
|
44,102
|
|
|
46,751
|
|
|||
Deferred taxes
|
|
(121,623
|
)
|
|
(53,276
|
)
|
|
62,195
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Increase in Sanofi, Bayer HealthCare, and trade accounts receivable
|
|
(491,421
|
)
|
|
(34,927
|
)
|
|
(245,472
|
)
|
|||
Increase in inventories
|
|
(111,825
|
)
|
|
(56,947
|
)
|
|
(47,956
|
)
|
|||
(Increase) decrease in prepaid expenses and other assets
|
|
(79,476
|
)
|
|
(45,327
|
)
|
|
7,571
|
|
|||
Increase (decrease) in deferred revenue
|
|
608,892
|
|
|
(8,403
|
)
|
|
(41,496
|
)
|
|||
Increase in accounts payable, accrued expenses, and other liabilities
|
|
303,657
|
|
|
161,182
|
|
|
136,684
|
|
|||
Total adjustments
|
|
694,724
|
|
|
414,309
|
|
|
174,858
|
|
|||
Net cash provided by operating activities
|
|
1,330,780
|
|
|
752,435
|
|
|
588,596
|
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
|
(557,105
|
)
|
|
(564,188
|
)
|
|
(577,278
|
)
|
|||
Sales or maturities of marketable securities
|
|
327,437
|
|
|
476,417
|
|
|
378,146
|
|
|||
Capital expenditures
|
|
(677,933
|
)
|
|
(333,006
|
)
|
|
(156,323
|
)
|
|||
Net cash used in investing activities
|
|
(907,601
|
)
|
|
(420,777
|
)
|
|
(355,455
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||||||
Proceeds (payments) in connection with facility and capital lease obligations
|
|
26,020
|
|
|
(1,095
|
)
|
|
(2,024
|
)
|
|||
Repayments of convertible senior notes
|
|
(166,467
|
)
|
|
(220,639
|
)
|
|
—
|
|
|||
Payments in connection with reduction of outstanding warrants
|
|
(573,487
|
)
|
|
(294,552
|
)
|
|
—
|
|
|||
Proceeds from issuance of Common Stock
|
|
206,358
|
|
|
126,045
|
|
|
57,393
|
|
|||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(160,537
|
)
|
|
(267,584
|
)
|
|
(195,087
|
)
|
|||
Excess tax benefit from stock-based compensation
|
|
405,317
|
|
|
439,278
|
|
|
211,909
|
|
|||
Net cash (used in) provided by financing activities
|
|
(262,796
|
)
|
|
(218,547
|
)
|
|
72,191
|
|
|||
|
|
|
|
|
|
|
||||||
Net increase in cash and cash equivalents
|
|
160,383
|
|
|
113,111
|
|
|
305,332
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at beginning of period
|
|
648,719
|
|
|
535,608
|
|
|
230,276
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at end of period
|
|
$
|
809,102
|
|
|
$
|
648,719
|
|
|
$
|
535,608
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest (net of amounts capitalized)
|
|
$
|
10,582
|
|
|
$
|
20,348
|
|
|
$
|
23,197
|
|
Cash paid for income taxes
|
|
$
|
276,092
|
|
|
$
|
59,847
|
|
|
$
|
1,057
|
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
•
|
EYLEA
®
(aflibercept) Injection
,
known in the scientific literature as VEGF Trap-Eye, which is available in the United States, European Union ("EU"), Japan, and certain other countries outside the United States for the treatment of neovascular age-related macular degeneration ("wet AMD"), diabetic macular edema ("DME"), macular edema following retinal vein occlusion ("RVO"), which includes macular edema following central retinal vein occlusion ("CRVO") and macular edema following branch retinal vein occlusion ("BRVO"). EYLEA is also available in Japan and the EU for the treatment of myopic choroidal neovascularization ("mCNV") and in the United States for the treatment of diabetic retinopathy in patients with DME.
|
•
|
Praluent
®
(alirocumab) Injection
,
which was approved by the U.S. Food and Drug Administration ("FDA") in July 2015 as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease ("ASCVD"), who require additional lowering of low-density lipoprotein ("LDL") cholesterol. In September 2015, the European Commission granted marketing authorization of Praluent for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia ("HeFH") and non-familial) or mixed dyslipidemia as an adjunct to diet: (a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated dose of a statin, or (b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
|
•
|
ARCALYST
®
(rilonacept) Injection for Subcutaneous Use
, which is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes ("CAPS"), including Familial Cold Auto-inflammatory Syndrome ("FCAS") and Muckle-Wells Syndrome ("MWS"), in adults and children 12 and older.
|
•
|
Included in Sanofi collaboration revenue is the Company's share of profits or losses from commercialization of antibodies, which is provided by Sanofi, and include an estimate of the Company's share of profits or losses for the most recent fiscal quarter.
|
•
|
Included in Bayer HealthCare collaboration revenue is the Company's share of profits or losses from commercialization of EYLEA outside the United States, which is provided by Bayer HealthCare, and includes an estimate of the Company's share of profits or losses for the most recent fiscal quarter.
|
•
|
Included in research and development expenses is the Company's share of development expenses incurred by Bayer HealthCare and Sanofi, including the Company's share of Bayer HealthCare and Sanofi estimated development expenses for the most recent fiscal quarter.
|
Building and improvements
|
|
10-30 years
|
Laboratory and other equipment
|
|
3-10 years
|
Furniture and fixtures
|
|
5 years
|
|
Rebates &
Chargebacks
|
|
Distribution-
Related
Fees
|
|
Other Sales-
Related
Deductions
|
|
Total
|
||||||||
Balance as of December 31, 2012
|
$
|
2,983
|
|
|
$
|
15,298
|
|
|
$
|
545
|
|
|
$
|
18,826
|
|
Provision related to current period sales
|
25,936
|
|
|
62,984
|
|
|
955
|
|
|
89,875
|
|
||||
Credits/payments
|
(24,519
|
)
|
|
(58,619
|
)
|
|
(962
|
)
|
|
(84,100
|
)
|
||||
Balance as of December 31, 2013
|
4,400
|
|
|
19,663
|
|
|
538
|
|
|
24,601
|
|
||||
Provision related to current period sales
|
33,117
|
|
|
77,160
|
|
|
1,578
|
|
|
111,855
|
|
||||
Credits/payments
|
(34,434
|
)
|
|
(75,657
|
)
|
|
(1,584
|
)
|
|
(111,675
|
)
|
||||
Balance as of December 31, 2014
|
3,083
|
|
|
21,166
|
|
|
532
|
|
|
24,781
|
|
||||
Provision related to current period sales
|
61,124
|
|
|
122,466
|
|
|
9,600
|
|
|
193,190
|
|
||||
Credits/payments
|
(57,788
|
)
|
|
(95,319
|
)
|
|
(9,615
|
)
|
|
(162,722
|
)
|
||||
Balance as of December 31, 2015
|
$
|
6,419
|
|
|
$
|
48,313
|
|
|
$
|
517
|
|
|
$
|
55,249
|
|
|
|
Year Ended December 31,
|
||||||||||
Sanofi Collaboration Revenue
|
|
2015
|
|
2014
|
|
2013
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
735,439
|
|
|
$
|
547,761
|
|
|
$
|
453,489
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
157,350
|
|
|
19,480
|
|
|
1,868
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(240,042
|
)
|
|
(41,378
|
)
|
|
—
|
|
|||
Up-front payments to Sanofi for acquisition of rights related to two antibodies
|
|
—
|
|
|
—
|
|
|
(20,000
|
)
|
|||
Other
|
|
10,243
|
|
|
10,243
|
|
|
10,243
|
|
|||
Total Antibody
|
|
662,990
|
|
|
536,106
|
|
|
445,600
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
39,961
|
|
|
—
|
|
|
—
|
|
|||
Other
|
|
40,000
|
|
|
—
|
|
|
—
|
|
|||
Total Immuno-oncology
|
|
79,961
|
|
|
—
|
|
|
—
|
|
|||
ZALTRAP:
|
|
|
|
|
|
|
||||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
—
|
|
|
(4,715
|
)
|
|
(30,810
|
)
|
|||
Reimbursement of Regeneron research and development expenses
|
|
686
|
|
|
4,806
|
|
|
5,639
|
|
|||
Other
|
|
15,236
|
|
|
5,102
|
|
|
9,682
|
|
|||
Total ZALTRAP
|
|
15,922
|
|
|
5,193
|
|
|
(15,489
|
)
|
|||
|
|
$
|
758,873
|
|
|
$
|
541,299
|
|
|
$
|
430,111
|
|
|
|
December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
Antibody:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
126,687
|
|
|
$
|
110,559
|
|
Deferred revenue
|
|
84,237
|
|
|
64,408
|
|
||
|
|
|
|
|
||||
Immuno-oncology:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
21,394
|
|
|
—
|
|
|
Deferred revenue
|
|
600,000
|
|
|
—
|
|
|
|
Year Ended December 31,
|
||||||||||
Bayer HealthCare Collaboration Revenue
|
|
2015
|
|
2014
|
|
2013
|
||||||
EYLEA:
|
|
|
|
|
|
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
466,667
|
|
|
$
|
301,302
|
|
|
$
|
101,494
|
|
Sales and substantive development milestones
|
|
15,000
|
|
|
105,000
|
|
|
70,000
|
|
|||
Cost-sharing of Regeneron EYLEA development expenses
|
|
8,887
|
|
|
23,383
|
|
|
20,905
|
|
|||
Other
|
|
69,466
|
|
|
52,390
|
|
|
27,890
|
|
|||
Total EYLEA
|
|
560,020
|
|
|
482,075
|
|
|
220,289
|
|
|||
PDGFR-beta antibody:
|
|
|
|
|
|
|
||||||
Cost-sharing of REGN2176-3 development expenses
|
|
10,075
|
|
|
2,848
|
|
|
—
|
|
|||
Other
|
|
10,393
|
|
|
10,632
|
|
|
—
|
|
|||
Total PDGFR-beta
|
|
20,468
|
|
|
13,480
|
|
|
—
|
|
|||
|
|
$
|
580,488
|
|
|
$
|
495,555
|
|
|
$
|
220,289
|
|
|
|
December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
EYLEA:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
160,755
|
|
|
$
|
124,293
|
|
Deferred revenue
|
|
46,694
|
|
|
28,752
|
|
||
|
|
|
|
|
||||
PDGFR-beta antibody:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
1,397
|
|
|
$
|
1,191
|
|
Deferred revenue
|
|
9,522
|
|
|
19,909
|
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
As of December 31, 2015
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
$
|
770,092
|
|
|
$
|
156
|
|
|
$
|
(2,565
|
)
|
|
$
|
767,683
|
|
U.S. government and government agency obligations
|
|
51,402
|
|
|
—
|
|
|
(193
|
)
|
|
51,209
|
|
||||
Municipal bonds
|
|
17,930
|
|
|
5
|
|
|
(11
|
)
|
|
17,924
|
|
||||
Equity securities
|
|
17,005
|
|
|
14,461
|
|
|
—
|
|
|
31,466
|
|
||||
|
|
$
|
856,429
|
|
|
$
|
14,622
|
|
|
$
|
(2,769
|
)
|
|
$
|
868,282
|
|
As of December 31, 2014
|
|
|
|
|
|
|
|
|
||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
$
|
548,832
|
|
|
$
|
136
|
|
|
$
|
(1,462
|
)
|
|
$
|
547,506
|
|
U.S. government and government agency obligations
|
|
28,596
|
|
|
3
|
|
|
(46
|
)
|
|
28,553
|
|
||||
Municipal bonds
|
|
37,044
|
|
|
37
|
|
|
(43
|
)
|
|
37,038
|
|
||||
Equity securities
|
|
2,005
|
|
|
5,374
|
|
|
—
|
|
|
7,379
|
|
||||
|
|
616,477
|
|
|
5,550
|
|
|
(1,551
|
)
|
|
620,476
|
|
||||
Restricted
|
|
|
|
|
|
|
|
|
||||||||
Equity securities
|
|
15,000
|
|
|
76,439
|
|
|
—
|
|
|
91,439
|
|
||||
|
|
$
|
631,477
|
|
|
$
|
81,989
|
|
|
$
|
(1,551
|
)
|
|
$
|
711,915
|
|
|
|
As of December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
Maturities within one year
|
|
$
|
236,121
|
|
|
$
|
251,761
|
|
Maturities after one year through five years
|
|
600,695
|
|
|
360,208
|
|
||
Maturities after five years through ten years
|
|
—
|
|
|
1,128
|
|
||
|
|
$
|
836,816
|
|
|
$
|
613,097
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
As of December 31, 2015
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
$
|
668,199
|
|
|
$
|
(2,473
|
)
|
|
$
|
23,749
|
|
|
$
|
(92
|
)
|
|
$
|
691,948
|
|
|
$
|
(2,565
|
)
|
U.S. government and government agency obligations
|
51,215
|
|
|
(193
|
)
|
|
—
|
|
|
—
|
|
|
51,215
|
|
|
(193
|
)
|
||||||
Municipal bonds
|
11,917
|
|
|
(11
|
)
|
|
—
|
|
|
—
|
|
|
11,917
|
|
|
(11
|
)
|
||||||
|
$
|
731,331
|
|
|
$
|
(2,677
|
)
|
|
$
|
23,749
|
|
|
$
|
(92
|
)
|
|
$
|
755,080
|
|
|
$
|
(2,769
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
As of December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Corporate bonds
|
$
|
390,613
|
|
|
$
|
(1,462
|
)
|
|
—
|
|
|
—
|
|
|
$
|
390,613
|
|
|
$
|
(1,462
|
)
|
||
U.S. government and government agency obligations
|
25,549
|
|
|
(46
|
)
|
|
—
|
|
|
—
|
|
|
25,549
|
|
|
(46
|
)
|
||||||
Municipal bonds
|
10,779
|
|
|
(43
|
)
|
|
—
|
|
|
—
|
|
|
10,779
|
|
|
(43
|
)
|
||||||
|
$
|
426,941
|
|
|
$
|
(1,551
|
)
|
|
—
|
|
|
—
|
|
|
$
|
426,941
|
|
|
$
|
(1,551
|
)
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||
As of December 31, 2015
|
Fair Value
|
|
Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
Unrestricted
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
767,683
|
|
|
—
|
|
|
$
|
767,683
|
|
|
U.S. government and government agency obligations
|
51,209
|
|
|
—
|
|
|
51,209
|
|
|||
Municipal bonds
|
17,924
|
|
|
—
|
|
|
17,924
|
|
|||
Equity securities
|
31,466
|
|
|
$
|
31,466
|
|
|
—
|
|
||
|
$
|
868,282
|
|
|
$
|
31,466
|
|
|
$
|
836,816
|
|
|
|
|
|
|
|
||||||
As of December 31, 2014
|
|
|
|
|
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
Unrestricted
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
547,506
|
|
|
—
|
|
|
$
|
547,506
|
|
|
U.S. government and government agency obligations
|
28,553
|
|
|
—
|
|
|
28,553
|
|
|||
Municipal bonds
|
37,038
|
|
|
—
|
|
|
37,038
|
|
|||
Equity securities
|
7,379
|
|
|
$
|
7,379
|
|
|
—
|
|
||
|
620,476
|
|
|
7,379
|
|
|
613,097
|
|
|||
Restricted
|
|
|
|
|
|
||||||
Equity securities
|
91,439
|
|
|
—
|
|
|
91,439
|
|
|||
|
$
|
711,915
|
|
|
$
|
7,379
|
|
|
$
|
704,536
|
|
|
As of December 31,
|
||||||
|
2015
|
|
2014
|
||||
Land
|
$
|
77,826
|
|
|
$
|
2,768
|
|
Building and improvements
|
760,517
|
|
|
398,981
|
|
||
Leasehold improvements
|
95,226
|
|
|
42,600
|
|
||
Construction-in-progress
|
579,834
|
|
|
472,231
|
|
||
Laboratory and other equipment
|
330,432
|
|
|
253,058
|
|
||
Furniture, computer and office equipment, and other
|
81,381
|
|
|
58,655
|
|
||
|
1,925,216
|
|
|
1,228,293
|
|
||
Less, accumulated depreciation and amortization
|
(331,096
|
)
|
|
(253,984
|
)
|
||
|
$
|
1,594,120
|
|
|
$
|
974,309
|
|
|
As of December 31,
|
||||||
|
2015
|
|
2014
|
||||
Accounts payable
|
$
|
140,962
|
|
|
$
|
99,508
|
|
Accrued payroll and related costs
|
133,223
|
|
|
92,778
|
|
||
Accrued clinical trial expense
|
88,297
|
|
|
41,555
|
|
||
Accrued sales-related charges, deductions, and royalties
|
195,986
|
|
|
133,085
|
|
||
Other accrued expenses and liabilities
|
85,644
|
|
|
116,563
|
|
||
|
$
|
644,112
|
|
|
$
|
483,489
|
|
|
As of December 31,
|
||||||
|
2015
|
|
2014
|
||||
Current portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
101,573
|
|
|
$
|
15,927
|
|
Received or receivable from Bayer HealthCare (see Note 3b)
|
24,290
|
|
|
33,652
|
|
||
Received for technology license agreement (see Note 4)
|
23,572
|
|
|
23,572
|
|
||
Other
|
4,052
|
|
|
874
|
|
||
|
$
|
153,487
|
|
|
$
|
74,025
|
|
Long-term portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
582,664
|
|
|
$
|
62,819
|
|
Received or receivable from Bayer HealthCare (see Note 3b)
|
31,926
|
|
|
15,007
|
|
||
Received for technology license agreement (see Note 4)
|
33,851
|
|
|
57,423
|
|
||
Other
|
16,238
|
|
|
—
|
|
||
|
$
|
664,679
|
|
|
$
|
135,249
|
|
|
|
As of December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
Total convertible senior notes - par
|
|
$
|
11,154
|
|
|
$
|
169,400
|
|
Unamortized discount
|
|
(352
|
)
|
|
(22,627
|
)
|
||
|
|
$
|
10,802
|
|
|
$
|
146,773
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Contractual coupon interest rate
|
|
$
|
544
|
|
|
$
|
5,036
|
|
|
$
|
7,230
|
|
Amortization of discount and note issuance costs
|
|
2,818
|
|
|
17,821
|
|
|
22,980
|
|
|||
|
|
$
|
3,362
|
|
|
$
|
22,857
|
|
|
$
|
30,210
|
|
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2016
|
|
$
|
10,894
|
|
|
$
|
4,594
|
|
|
$
|
15,488
|
|
2017
|
|
11,332
|
|
|
425
|
|
|
11,757
|
|
|||
2018
|
|
11,607
|
|
|
140
|
|
|
11,747
|
|
|||
2019
|
|
11,740
|
|
|
—
|
|
|
11,740
|
|
|||
2020
|
|
11,375
|
|
|
—
|
|
|
11,375
|
|
|||
Thereafter
|
|
50,746
|
|
|
—
|
|
|
50,746
|
|
|||
|
|
$
|
107,694
|
|
|
$
|
5,159
|
|
|
$
|
112,853
|
|
Year Ended December 31,
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2015
|
|
$
|
14,659
|
|
|
$
|
543
|
|
|
$
|
15,202
|
|
2014
|
|
13,360
|
|
|
952
|
|
|
14,312
|
|
|||
2013
|
|
9,404
|
|
|
471
|
|
|
9,875
|
|
|
As of December 31,
|
||||||
|
2015
|
|
2014
|
||||
Buildings A and B
|
$
|
108,857
|
|
|
$
|
110,210
|
|
Building C
|
49,475
|
|
|
49,312
|
|
||
Buildings D and E
|
206,376
|
|
|
152,770
|
|
||
|
$
|
364,708
|
|
|
$
|
312,292
|
|
|
|
Buildings A and B
|
|
Building C
|
|
Buildings D and E
|
|
Total
|
||||||||
2016
|
|
$
|
13,809
|
|
|
$
|
4,688
|
|
|
$
|
12,679
|
|
|
$
|
31,176
|
|
2017
|
|
14,079
|
|
|
4,818
|
|
|
13,016
|
|
|
31,913
|
|
||||
2018
|
|
14,356
|
|
|
4,951
|
|
|
13,360
|
|
|
32,667
|
|
||||
2019
|
|
14,640
|
|
|
5,088
|
|
|
13,714
|
|
|
33,442
|
|
||||
2020
|
|
14,931
|
|
|
5,227
|
|
|
14,076
|
|
|
34,234
|
|
||||
Thereafter
|
|
117,096
|
|
|
54,760
|
|
|
137,079
|
|
|
308,935
|
|
||||
|
|
$
|
188,911
|
|
|
$
|
79,532
|
|
|
$
|
203,924
|
|
|
$
|
472,367
|
|
a.
|
Stock Options
|
Stock Options:
|
|
Number of Shares
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term (in years)
|
|
Intrinsic Value (in thousands)
|
||||||
Outstanding as of December 31, 2014
|
|
21,506,260
|
|
|
$
|
158.54
|
|
|
|
|
|
|
||
2015:
|
Granted
|
|
4,495,487
|
|
|
$
|
537.29
|
|
|
|
|
|
||
|
Forfeited
|
|
(318,952
|
)
|
|
$
|
292.14
|
|
|
|
|
|
||
|
Expired
|
|
(363
|
)
|
|
$
|
92.20
|
|
|
|
|
|
||
|
Exercised
|
|
(2,516,663
|
)
|
|
$
|
98.26
|
|
|
|
|
|
||
Outstanding as of December 31, 2015
|
|
23,165,769
|
|
|
$
|
236.75
|
|
|
6.82
|
|
$
|
7,209,994,851
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vested and expected to vest as of December 31, 2015
|
|
22,635,728
|
|
|
$
|
231.75
|
|
|
6.76
|
|
$
|
7,156,754,651
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable as of December 31, 2015
|
|
13,212,236
|
|
|
$
|
103.67
|
|
|
5.23
|
|
$
|
5,852,659,560
|
|
|
|
Number of Options Granted
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Fair Value
|
|||||
2015:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
4,495,487
|
|
|
$
|
537.29
|
|
|
$
|
181.65
|
|
2014:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
3,913,368
|
|
|
$
|
385.33
|
|
|
$
|
140.38
|
|
2013:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
3,937,989
|
|
|
$
|
263.77
|
|
|
$
|
104.90
|
|
|
|
2015
|
|
2014
|
|
2013
|
|||
Expected volatility
|
|
35
|
%
|
|
39
|
%
|
|
42
|
%
|
Expected lives from grant date
|
|
5.1 years
|
|
|
5.2 years
|
|
|
5.3 years
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk-free interest rate
|
|
1.68
|
%
|
|
1.62
|
%
|
|
1.73
|
%
|
b.
|
Restricted Stock
|
Restricted Stock:
|
|
Number of Shares
|
|
Weighted-Average Grant Date Fair Value
|
||||
Outstanding as of December 31, 2014
|
|
546,060
|
|
|
$
|
115.26
|
|
|
2015:
|
Granted
|
|
27,520
|
|
|
$
|
540.40
|
|
|
Vested
|
|
(31,880
|
)
|
|
$
|
164.65
|
|
Outstanding as of December 31, 2015
|
|
541,700
|
|
|
$
|
133.96
|
|
|
December 31, 2014
|
||||||||||
|
As Previously Reported
|
|
Adjustments
|
|
As Revised
|
||||||
Balance Sheet Data:
|
|
|
|
|
|
||||||
Deferred tax assets
|
$
|
316,104
|
|
|
$
|
22,152
|
|
|
$
|
338,256
|
|
Total assets
|
3,871,827
|
|
|
22,152
|
|
|
3,893,979
|
|
|||
Additional paid-in capital
|
2,404,118
|
|
|
60,890
|
|
|
2,465,008
|
|
|||
Retained earnings
|
255,382
|
|
|
(38,738
|
)
|
|
216,644
|
|
|||
Total stockholders' equity
|
2,542,325
|
|
|
22,152
|
|
|
2,564,477
|
|
|||
Total liabilities and stockholders' equity
|
3,871,827
|
|
|
22,152
|
|
|
3,893,979
|
|
|
Three Months Ended
December 31, 2014
(Unaudited)
|
||||||||||
|
As Previously Reported
|
|
Adjustments
|
|
As Revised
|
||||||
Consolidated Statement of Operations Data:
|
|
|
|
|
|
||||||
Selling, general, and administrative
|
$
|
143,743
|
|
|
$
|
31,564
|
|
|
$
|
175,307
|
|
Total operating expenses
|
554,962
|
|
|
31,564
|
|
|
586,526
|
|
|||
Income from operations
|
247,367
|
|
|
(31,564
|
)
|
|
215,803
|
|
|||
Income before income taxes
|
221,287
|
|
|
(31,564
|
)
|
|
189,723
|
|
|||
Income tax expense
|
111,111
|
|
|
(11,483
|
)
|
|
99,628
|
|
|||
Net income
|
110,176
|
|
|
(20,081
|
)
|
|
90,095
|
|
|||
Net income per share - basic
|
$
|
1.09
|
|
|
$
|
(0.20
|
)
|
|
$
|
0.89
|
|
Net income per share - diluted
|
$
|
0.96
|
|
|
$
|
(0.18
|
)
|
|
$
|
0.78
|
|
|
Year Ended
December 31, 2014
|
|
Year Ended
December 31, 2013
|
||||||||||||||||||||
|
As Previously Reported
|
|
Adjustments
|
|
As Revised
|
|
As Previously Reported
|
|
Adjustments
|
|
As Revised
|
||||||||||||
Consolidated Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Selling, general, and administrative
|
$
|
504,755
|
|
|
$
|
14,512
|
|
|
$
|
519,267
|
|
|
$
|
329,415
|
|
|
$
|
16,978
|
|
|
$
|
346,393
|
|
Total operating expenses
|
1,981,126
|
|
|
14,512
|
|
|
1,995,638
|
|
|
1,344,717
|
|
|
16,978
|
|
|
1,361,695
|
|
||||||
Income from operations
|
838,431
|
|
|
(14,512
|
)
|
|
823,919
|
|
|
760,028
|
|
|
(16,978
|
)
|
|
743,050
|
|
||||||
Income before income taxes
|
775,747
|
|
|
(14,512
|
)
|
|
761,235
|
|
|
713,360
|
|
|
(16,978
|
)
|
|
696,382
|
|
||||||
Income tax expense
|
427,673
|
|
|
(4,564
|
)
|
|
423,109
|
|
|
288,998
|
|
|
(6,354
|
)
|
|
282,644
|
|
||||||
Net income
|
348,074
|
|
|
(9,948
|
)
|
|
338,126
|
|
|
424,362
|
|
|
(10,624
|
)
|
|
413,738
|
|
||||||
Net income per share - basic
|
$
|
3.46
|
|
|
$
|
(0.10
|
)
|
|
$
|
3.36
|
|
|
$
|
4.33
|
|
|
$
|
(0.10
|
)
|
|
$
|
4.23
|
|
Net income per share - diluted
|
$
|
3.07
|
|
|
$
|
(0.09
|
)
|
|
$
|
2.98
|
|
|
$
|
3.81
|
|
|
$
|
(0.09
|
)
|
|
$
|
3.72
|
|
|
Year Ended
December 31, 2014
|
|
Year Ended
December 31, 2013
|
||||||||||||||||||||
|
As Previously Reported
|
|
Adjustments
|
|
As Revised
|
|
As Previously Reported
|
|
Adjustments
|
|
As Revised
|
||||||||||||
Consolidated Statement of Cash Flows Data:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net income
|
$
|
348,074
|
|
|
$
|
(9,948
|
)
|
|
$
|
338,126
|
|
|
$
|
424,362
|
|
|
$
|
(10,624
|
)
|
|
$
|
413,738
|
|
Non-cash compensation expense
|
307,238
|
|
|
14,512
|
|
|
321,750
|
|
|
198,399
|
|
|
16,978
|
|
|
215,377
|
|
||||||
Deferred taxes
|
(66,604
|
)
|
|
(4,564
|
)
|
|
(71,168
|
)
|
|
63,601
|
|
|
(6,354
|
)
|
|
57,247
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
United States
|
$
|
1,665,087
|
|
|
$
|
1,101,446
|
|
|
$
|
795,300
|
|
|
Foreign
|
(439,990
|
)
|
|
(340,211
|
)
|
|
(98,918
|
)
|
||||
|
|
$
|
1,225,097
|
|
|
$
|
761,235
|
|
|
$
|
696,382
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Current:
|
|
|
|
|
|
|||||||
|
Federal
|
$
|
686,561
|
|
|
$
|
437,038
|
|
|
$
|
196,527
|
|
|
State
|
28,568
|
|
|
28,718
|
|
|
23,489
|
|
|||
|
Foreign
|
4,004
|
|
|
2,879
|
|
|
433
|
|
|||
|
Total current tax expense
|
719,133
|
|
|
468,635
|
|
|
220,449
|
|
|||
Deferred:
|
|
|
|
|
|
|||||||
|
Federal
|
(119,849
|
)
|
|
(62,932
|
)
|
|
53,504
|
|
|||
|
State
|
(3,768
|
)
|
|
18,891
|
|
|
8,700
|
|
|||
|
Foreign
|
(6,475
|
)
|
|
(1,485
|
)
|
|
(9
|
)
|
|||
|
Total deferred tax (benefit) expense
|
(130,092
|
)
|
|
(45,526
|
)
|
|
62,195
|
|
|||
|
$
|
589,041
|
|
|
$
|
423,109
|
|
|
$
|
282,644
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
U.S. federal statutory tax rate
|
35.0
|
%
|
|
35.0
|
%
|
|
35.0
|
%
|
State and local income taxes
|
1.0
|
|
|
2.4
|
|
|
3.4
|
|
Change in state effective rate
|
(0.1
|
)
|
|
2.9
|
|
|
—
|
|
Foreign income tax rate differential
|
12.2
|
|
|
15.8
|
|
|
4.9
|
|
Income tax credits
|
(1.6
|
)
|
|
(5.1
|
)
|
|
(4.9
|
)
|
Non-deductible Branded Prescription Drug Fee
|
2.0
|
|
|
2.8
|
|
|
1.1
|
|
Domestic production activities deduction
|
(3.2
|
)
|
|
—
|
|
|
—
|
|
Other permanent differences
|
2.8
|
|
|
1.8
|
|
|
1.1
|
|
Effective income tax rate
|
48.1
|
%
|
|
55.6
|
%
|
|
40.6
|
%
|
|
|
As of December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating loss carryforward
|
|
$
|
140
|
|
|
$
|
150
|
|
Fixed assets
|
|
—
|
|
|
8,078
|
|
||
Deferred revenue
|
|
51,766
|
|
|
60,223
|
|
||
Deferred compensation
|
|
349,508
|
|
|
216,640
|
|
||
Income tax credit carryforwards
|
|
—
|
|
|
8,539
|
|
||
Capitalized research and development costs
|
|
7,725
|
|
|
12,908
|
|
||
Accrued expenses
|
|
47,520
|
|
|
19,331
|
|
||
Other
|
|
26,580
|
|
|
21,922
|
|
||
|
|
483,239
|
|
|
347,791
|
|
||
Valuation allowance
|
|
—
|
|
|
(359
|
)
|
||
Total deferred tax assets
|
|
483,239
|
|
|
347,432
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
||||
Unrealized gains/losses on marketable securities
|
|
(3,280
|
)
|
|
(28,186
|
)
|
||
Fixed assets
|
|
(5,559
|
)
|
|
—
|
|
||
Convertible senior notes
|
|
—
|
|
|
(252
|
)
|
||
Other
|
|
(12,455
|
)
|
|
(3,578
|
)
|
||
Total deferred tax liabilities
|
|
(21,294
|
)
|
|
(32,016
|
)
|
||
Net deferred tax assets
|
|
$
|
461,945
|
|
|
$
|
315,416
|
|
|
|
2015
|
|
2014
|
|
2013
|
||||||
Balance as of January 1
|
|
$
|
57,615
|
|
|
$
|
26,627
|
|
|
$
|
11,274
|
|
Gross increases related to current year tax positions
|
|
59,909
|
|
|
27,538
|
|
|
7,620
|
|
|||
Gross (decreases) increases related to prior year tax positions
|
|
(952
|
)
|
|
6,464
|
|
|
8,305
|
|
|||
Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation
|
|
—
|
|
|
(3,014
|
)
|
|
(572
|
)
|
|||
Balance as of December 31
|
|
$
|
116,572
|
|
|
$
|
57,615
|
|
|
$
|
26,627
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Net income - basic and diluted
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
$
|
413,738
|
|
|
|
|
|
|
|
|
||||||
(Shares in thousands)
|
|
|
|
|
|
|
||||||
Weighted average shares - basic
|
|
103,061
|
|
|
100,612
|
|
|
97,917
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
9,446
|
|
|
9,440
|
|
|
10,233
|
|
|||
Restricted stock
|
|
477
|
|
|
425
|
|
|
433
|
|
|||
Warrants
|
|
2,246
|
|
|
2,936
|
|
|
2,707
|
|
|||
Dilutive potential shares
|
|
12,169
|
|
|
12,801
|
|
|
13,373
|
|
|||
Weighted average shares - diluted
|
|
115,230
|
|
|
113,413
|
|
|
111,290
|
|
|||
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
|
$
|
4.23
|
|
Net income per share - diluted
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
$
|
3.72
|
|
|
|
Year Ended December 31,
|
|||||||
(Shares in thousands)
|
|
2015
|
|
2014
|
|
2013
|
|||
Stock options
|
|
1,343
|
|
|
1,470
|
|
|
304
|
|
Convertible senior notes
|
|
994
|
|
|
4,247
|
|
|
4,761
|
|
|
|
First Quarter Ended
March 31, 2015
|
|
Second Quarter Ended
June 30, 2015
|
|
Third Quarter Ended
September 30, 2015
|
|
Fourth Quarter Ended
December 31, 2015
|
||||||||
|
|
(Unaudited)
|
||||||||||||||
Revenues
|
|
$
|
869,612
|
|
|
$
|
998,617
|
|
|
$
|
1,137,422
|
|
|
$
|
1,098,077
|
|
Net income
|
|
$
|
76,021
|
|
|
$
|
194,643
|
|
|
$
|
210,398
|
|
|
$
|
154,994
|
|
Net income per share - basic
|
|
$
|
0.74
|
|
|
$
|
1.89
|
|
|
$
|
2.04
|
|
|
$
|
1.49
|
|
Net income per share - diluted
|
|
$
|
0.66
|
|
|
$
|
1.69
|
|
|
$
|
1.82
|
|
|
$
|
1.34
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
First Quarter Ended
March 31, 2014
*
|
|
Second Quarter Ended
June 30, 2014
*
|
|
Third Quarter Ended
September 30, 2014
*
|
|
Fourth Quarter Ended
December 31, 2014
*
|
||||||||
|
|
(Unaudited)
|
||||||||||||||
Revenues
|
|
$
|
625,740
|
|
|
$
|
665,700
|
|
|
$
|
725,788
|
|
|
$
|
802,329
|
|
Net income
(1)
|
|
$
|
68,305
|
|
|
$
|
96,351
|
|
|
$
|
83,375
|
|
|
$
|
90,095
|
|
Net income per share - basic
|
|
$
|
0.69
|
|
|
$
|
0.96
|
|
|
$
|
0.83
|
|
|
$
|
0.89
|
|
Net income per share - diluted
|
|
$
|
0.61
|
|
|
$
|
0.85
|
|
|
$
|
0.73
|
|
|
$
|
0.78
|
|
|
|
By:
|
/s/ Joseph J. LaRosa
|
|
|
Name:
|
Joseph J. LaRosa
|
|
|
Title:
|
Senior Vice President, General Counsel and Secretary
|
|
|
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
|
ID:
[ ]
|
|
Notice of Grant of Stock Options
|
777 Old Saw Mill River Road
|
|
and Option Agreement for Time-Based Vesting
|
Tarrytown, New York 10591
|
|
Option Awards
|
|
|
|
|
|
[OPTIONEE NAME]
|
Option Number:
|
[
]
|
[OPTIONEE ADDRESS
|
Plan:
|
[
]
|
|
ID
|
[
]
|
Shares
|
|
Vest Type
|
|
Full Vest
|
|
Expiration Date
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
Options will vest in approximately equal annual 25% installments. Full Vest Dates will occur on the first, second, third and fourth anniversaries of the Grant Date.
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
ID:
[ ]
|
|
Notice of Grant of Stock Options
|
777 Old Saw Mill River Road
|
|
and Option Agreement for Time Vesting
|
Tarrytown, New York 10591
|
|
Option Awards
|
|
|
|
|
|
[OPTIONEE NAME]
|
Option Number:
|
[
]
|
[OPTIONEE ADDRESS
|
Plan:
|
[
]
|
|
ID
|
[
]
|
Shares
|
|
Vest Type
|
|
Full Vest
|
|
Expiration Date
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
Options will vest in approximately equal annual 25% installments. Full Vest Dates will occur on the first, second, third and fourth anniversaries of the Grant Date.
|
Regeneron Pharmaceuticals, Inc.
|
|
|
||
|
|
|
||
Notice of Grant of Stock Options
|
|
ID:
[ ]
|
||
and Option Agreement
|
|
777 Old Saw Mill River Road
|
||
|
|
Tarrytown, New York 10591
|
||
[OPTIONEE NAME]
|
|
Option Number:
|
|
[ ]
|
[OPTIONEE ADDRESS]
|
|
Plan:
|
|
[ ]
|
|
|
ID
|
|
[ ]
|
|
|
|
|
|
|
|
Shares
|
|
Vest Type
|
|
Full Vest
|
|
Expiration Date
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
Options for non-employee directors will vest in approximately equal annual 33-1/3% installments. Full Vest Dates will occur on the first, second, and third anniversaries of the Grant Date.
|
Date:
|
November 15, 2015
|
|
|
To:
|
Regeneron Pharmaceuticals, Inc.
|
|
777 Old Saw Mill River Road
|
|
Tarrytown, NY 10591-6707
|
|
|
Attention:
|
Dominick Agron
|
|
VP and Treasurer
|
|
777 Old Saw Mill River Road
|
|
Tarrytown, NY 10591-6707
|
|
|
Facsimile:
|
(914) 847-1555
|
|
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From:
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Credit Suisse Capital LLC
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Eleven Madison Avenue
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New York, NY 10010
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With Credit Suisse Securities (USA) LLC as agent
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Eleven Madison Avenue
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New York, NY 10010
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Re:
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Fourth Amendment of the Warrant Transaction between Credit Suisse Capital LLC and
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Regeneron Pharmaceuticals, Inc. (this "
Amendment
")
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Daily Number of Warrants:
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For any Unwind Date, a number of Warrants as determined by Dealer, in its good-faith, commercially reasonable discretion, with respect to which Dealer has closed out its Hedge Positions with Shares purchased by Dealer on such Unwind Date and, if applicable, any Shares delivered by Issuer pursuant to clause (x) of paragraph 1 in Annex B in respect of such Unwind Date;
provided
that the sum of the Daily Number of Warrants shall not exceed the Maximum Number of Warrants (as defined below).
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Maximum Number of Warrants:
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476,376
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per Warrant:
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As set forth in Annex A, to be the amount specified for the relevant Unwind Date Price.
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Payment Amount:
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USD 200,000,000.00 (in the aggregate);
provided, however
, that: (i) the Maximum Amendment Payment Amount with respect to Unwind Dates where the Unwind Date Price is greater than USD 505.00 shall be USD 50,000,000.00 (in the aggregate); (ii) the Maximum Amendment Payment Amount with respect to Unwind Dates where the Unwind Date Price is greater than USD 475.00 shall be USD 100,000,000.00 (in the aggregate); and (iii) the Maximum Amendment Payment Amount with respect to Unwind Dates where the Unwind Date Price is greater than USD 455.00 shall be USD 150,000,000.00 (in the aggregate).
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Payment Date:
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For each Unwind Date, the third Currency Business Day following such Unwind Date.
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Unwind Date:
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Each Scheduled Trading Day during the Unwind Period on which Dealer has closed out its Hedge Positions in respect of Warrants.
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Unwind Period:
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Each Exchange Business Day during the period commencing on November 16, 2015 and ending on February 9, 2016 (inclusive).
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Unwind Date Price:
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For any Unwind Date, the volume-weighted average of the per Share prices at which Dealer purchases Shares in order to close out its Hedge Positions in respect of the Daily Number of Warrants on such Unwind Date;
provided
that Dealer shall not
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Limit Price:
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USD 535.00
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By:
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/s/ Barry Dixon
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Name:
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Barry Dixon
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Title:
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Authorized Signatory
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By:
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/s/ Carole Villoresi
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Name:
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Carole Villoresi
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Title:
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Authorized Signatory
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By:
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/s/ Barry Dixon
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Name:
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Barry Dixon
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Title:
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Director
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By:
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/s/ Dominick Agron
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Name:
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Dominick Agron
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Title:
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V.P. & Treasurer
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Unwind Date Price
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Amendment Payment Amount per Warrant
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$450.00
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$347.66
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$455.00
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$352.62
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$460.00
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$357.57
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$465.00
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$362.53
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$470.00
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$367.48
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$475.00
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$372.44
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$480.00
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$377.39
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$485.00
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$382.35
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$490.00
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$387.30
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$495.00
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$392.26
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$500.00
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$397.21
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$505.00
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$402.17
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$510.00
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$407.12
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$515.00
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$412.08
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$520.00
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$417.03
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$525.00
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$421.99
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$530.00
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$426.94
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$535.00
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$431.90
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$540.00
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$436.85
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Name of Subsidiary*
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State or Other Jurisdiction of Incorporation or Organization
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Loop Road Holdings LLC
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New York
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OSMR Holdings
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Bermuda
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OSMR International
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Bermuda
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Regeneron Capital International B.V.
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The Netherlands
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Regeneron Genetics Center LLC
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Delaware
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Regeneron Healthcare Solutions, Inc.
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New York
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Regeneron International
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Ireland
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Regeneron International Holdings LLC
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Delaware
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Regeneron Ireland
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Ireland
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Regeneron Ireland Holdings
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Ireland
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Regeneron Spain, S.L.U.
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Spain
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Regeneron UK Limited
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United Kingdom
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_____________
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* Directly or indirectly wholly owned by Regeneron Pharmaceuticals, Inc.
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||
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1.
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I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date:
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February 11, 2016
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/s/ Leonard S. Schleifer
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Leonard S. Schleifer, M.D., Ph.D.
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President and Chief Executive Officer
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(Principal Executive Officer)
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1.
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I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date:
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February 11, 2016
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/s/ Robert E. Landry
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Robert E. Landry
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Senior Vice President, Finance and Chief Financial Officer
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(Principal Financial Officer)
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(1)
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Leonard S. Schleifer
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Leonard S. Schleifer, M.D., Ph.D.
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President and Chief Executive Officer
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(Principal Executive Officer)
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February 11, 2016
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/s/ Robert E. Landry
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Robert E. Landry
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Senior Vice President, Finance and Chief Financial Officer
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(Principal Financial Officer)
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February 11, 2016
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