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, 2016
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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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The aggregate market value of the common stock held by non-affiliates of the registrant was approximately $35,224,000,000, computed by reference to the closing sales price of the stock on NASDAQ on June 30, 2016, the last trading day of the registrant's most recently completed second fiscal quarter. For purposes of this calculation only, the registrant has assumed that all of its directors and executive officers, and no other persons, are its affiliates. This determination of affiliate status is not necessarily a determination for other purposes.
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The number of shares outstanding of each of the registrant's classes of common stock as of February 1, 2017:
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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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1,911,456
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Common Stock, $.001 par value
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104,169,299
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DOCUMENTS INCORPORATED BY REFERENCE
:
Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its 2016 Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages 85 to 92 of this filing.
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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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EYLEA (aflibercept) Injection, which is approved by the U.S. Food and Drug Administration (FDA) for use in retinal indications, delivered U.S. net sales growth of
24.2%
over 2015, and continues to be the market-leading, branded anti-VEGF therapy in the United States. A Phase 3 study for the treatment of non-proliferative diabetic retinopathy (NPDR) in patients without DME was initiated.
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We, along with our partner Sanofi, received regulatory approval for Praluent in additional countries outside the United States. Praluent has been launched in the United States, Europe, and other countries. We also reported positive Phase 3 data from the ODYSSEY ESCAPE study of Praluent in patients with heterozygous familial hypercholesterolemia (HeFH) and consequently, high LDL cholesterol levels who were undergoing apheresis. A Phase 3 cardiovascular outcomes study of Praluent is ongoing.
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We reported positive efficacy and safety data from Phase 3 studies of Dupixent in patients with moderate-to-severe atopic dermatitis. The FDA accepted, and granted priority review for, the Biologics License Application (BLA) for Dupixent for the treatment of atopic dermatitis with a target action date of March 29, 2017. In addition, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for Dupixent for the treatment of atopic dermatitis. The FDA granted Breakthrough Therapy designation for Dupixent for the treatment of atopic dermatitis
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A Phase 3 study of fasinumab in patients with pain due to osteoarthritis of the knee or hip was initiated. A Phase 2b study of fasinumab in chronic low back pain was also initiated and later placed on clinical hold by the FDA. We completed an unplanned analysis of this Phase 2b study in chronic low back pain which showed clear evidence of efficacy with improvement in pain scores in all fasinumab groups compared to placebo.
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REGN2810 entered a potentially pivotal clinical study for the treatment of advanced cutaneous squamous cell carcinoma.
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Phase 2 studies of EYLEA, in a co-formulated combination with nesvacumab, an antibody to angiopoietin-2 (ANG2), advanced in clinical development for the treatment of wet AMD and DME.
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We advanced four new product candidates (REGN3500, REGN3470-3471-3479, REGN2477, and REGN3767) into Phase 1 clinical development.
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We entered into significant new research and development license and collaboration arrangements: a collaboration with Bayer for a co-formulated combination therapy of the Ang2 antibody nesvacumab and aflibercept for the treatment of serious eye diseases; a collaboration with Teva for fasinumab; a license and collaboration with Intellia Therapeutics, Inc. to advance CRISPR/Cas gene-editing technology for
in vivo
therapeutic development; and a license and collaboration agreement with Adicet Bio, Inc. to develop next-generation engineered immune-cell therapeutics with fully human chimeric antigen receptors and T-cell receptors directed to disease-specific cell surface antigens in order to enable the precise engagement and killing of tumor cells.
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Our initiatives in genomics also advanced, and we have sequenced over 150,000 exomes to date.
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From a company growth perspective, we hired our 5,000
th
employee, purchased an office building near our Tarrytown facility, purchased land and an office building near our Rensselaer, New York facilities, 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 the top employer in the global biotech and pharmaceutical industry by
Science
magazine. We have been ranked first for four of the past six years, with second place rankings in 2015 and 2011.
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Society for Science & the Public announced that Regeneron has become the new title sponsor of the Science Talent Search. Regeneron became only the third sponsor in 75 years of the nation's oldest and most prestigious high school science competition.
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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 the EU, Japan, and certain other countries outside the United States for the treatment of myopic choroidal neovascularization (mCNV) and in the United States for the treatment of diabetic retinopathy in patients with DME. Bayer has additional regulatory applications for EYLEA for various indications pending in other countries. We are collaborating with Bayer on the 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. Praluent is also available in certain countries in Europe for the treatment of adult patients with primary 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. In July 2016, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted marketing and manufacturing authorization for Praluent for the treatment of uncontrolled LDL cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk. 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. See Part I, Item 3. "Legal Proceedings" for information regarding the patent infringement proceedings relating to Praluent, which may impact Praluent's commercial availability in the United States and other jurisdictions.
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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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Kevzara
TM
(sarilumab) Solution for Subcutaneous Injection
. In January 2017, Health Canada approved Kevraza for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to or intolerance to one or more biologic or non-biologic disease modifying anti-rheumatic drugs (DMARDs). This is the first approval of Kevzara worldwide.
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ZALTRAP
®
(ziv-aflibercept) Injection for Intravenous Infusion
, known in the scientific literature as VEGF Trap, which is available in the United States, EU, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Pursuant to a 2015 amended and restated ZALTRAP agreement (Amended ZALTRAP Agreement), Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net sales of ZALTRAP.
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Trap-based Clinical Program
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EYLEA
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Phase 3 study for the treatment of Neovascular Glaucoma (NVG) (in Japan) was completed in 2016 (in collaboration with Bayer). Phase 3 study for the treatment of non-proliferative diabetic retinopathy in patients without DME initiated in the first quarter of 2016. As described below, aflibercept is also being studied in combination with nesvacumab, 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.
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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). Phase 2 study in Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) initiated in the third quarter of 2016.
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Dupixent (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 in adults and adolescents (Phase 3), and eosinophilic esophagitis (EoE) (Phase 2). Phase 3 study in patients with nasal polyps initiated in the fourth quarter of 2016.
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REGN2810
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Antibody to programmed cell death protein 1 (PD-1). In Phase 1 clinical development in solid tumors and advanced hematologic malignancies. Potentially pivotal Phase 2 study for the treatment of advanced cutaneous squamous cell carcinoma initiated in the second quarter of 2016. REGN 2810 is also being studied in combination with other antibodies and treatments.
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REGN3500
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Antibody to interleukin-33 receptor (IL-33) being developed for inflammatory diseases. Phase 1 study in healthy volunteers initiated in the third quarter of 2016. Phase 1 study in patients with mild asthma initiated in the first quarter of 2017.
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REGN3767
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Antibody to Lymphocyte Activation Gene 3 (LAG-3) protein. Phase 1 study (administered alone or in combination with REGN2810) in advanced malignancies initiated in the fourth quarter 2016.
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Antibody-based Clinical Program in Collaboration with Bayer
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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 2 studies for the treatment of wet AMD and DME initiated in the first quarter of 2016. Fast track designation received from the FDA for the treatment of patients with wet AMD, DME and diabetic retinopathy.
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Antibody-based Clinical Program in Collaboration with Teva and Mitsubishi Tanabe Pharma
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Fasinumab (REGN475)
*
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Antibody to Nerve Growth Factor (NGF). Phase 3 long-term safety and efficacy study in patients with osteoarthritis of knee and hip initiated in the first quarter of 2016. Phase 2b study for chronic low back pain initiated in the first quarter of 2016, and placed on clinical hold by the FDA in October 2016.
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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. In Phase 3 clinical development for prevention of RSV infection.
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Evinacumab (REGN1500)
*
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Antibody to Angptl-3. In Phase 2 clinical development for the treatment of homozygous familial hypercholesterolemia (HoFH) and severe forms of hyperlipidemia. FDA granted orphan drug designation for the treatment of HoFH.
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Trevogrumab (REGN1033)
*
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Antibody to myostatin (GDF8). Phase 2 monotherapy study in patients with sarcopenia completed. REGN1033 is being studied in combination with REGN2477.
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REGN1908-1909
*
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Antibody to Feld1. In Phase 1 clinical development for the treatment of 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, Chronic Lymphocytic Leukemia, and Acute Lymphoblastic Leukemia. REGN1979 is also being studied in combination with REGN2810 in B-cell malignancies.
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REGN3470-3471-3479
***
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Antibody to Ebola virus. Phase 1 study in healthy volunteers initiated in the second quarter of 2016. Also in the second quarter of 2016, the FDA granted orphan drug designation for the treatment of Ebola virus infection.
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REGN2477
*
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Antibody to Activin A being developed for Fibrodysplasia Ossificans Progressiva (FOP). Phase 1 study in combination with REGN1033 in healthy volunteers initiated in the second quarter of 2016. FDA granted orphan drug designation for the treatment of FOP.
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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 Ang2 receptor and ligand in ophthalmology were previously included in our antibody collaboration with Sanofi. Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate and a potential development milestone.
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***
Sanofi did not opt-in to the product candidate. Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate. In 2015, we and the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) entered into an agreement whereby HHS provides certain funding to support research, development, and manufacturing of a monoclonal antibody therapy for the treatment of Ebola virus infection.
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Ninety-three percent of patients treated with Praluent experienced at least a 50% reduction in their apheresis
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Throughout the trial, patients treated with Praluent experienced significant reductions in their LDL cholesterol starting
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A similar proportion of patients experienced adverse events (AEs) in both the Praluent and placebo groups (76% in both groups). The most common AEs (occurring in at least 5% of the Praluent group) were fatigue (15% Praluent; 10% placebo), nasopharyngitis (10% Praluent; 10% placebo), diarrhea (10% Praluent; 0% placebo), myalgia (10% Praluent; 5% placebo), upper respiratory infection (7% Praluent; 19% placebo), headache (7% Praluent; 5% placebo), arthralgia (7% Praluent; 10% placebo), and back pain (5% Praluent; 10% placebo).
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For SOLO 1 and SOLO 2, respectively, 37% and 36% of patients who received Dupixent 300 mg weekly, and 38% and 36% of patients who received Dupixent 300 mg every two weeks, achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10% and 8.5% with placebo (p<0.0001). This was the primary endpoint of the study in the United States.
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For SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72% and 69% in patients who received the 300 mg weekly dose, and 72% and 67% for patients who received Dupixent 300 mg every two weeks, compared to 38% and 31% for placebo (p<0.0001).
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For SOLO 1 and SOLO 2, respectively, 52.5% and 48% of patients who received Dupixent 300 mg weekly, and 51% and 44% of patients who received Dupixent 300 mg every two weeks, achieved EASI-75 compared to 15% and 12% with placebo (p<0.0001). This was the key secondary endpoint in the United States and one of the primary endpoints in the EU.
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39% of patients who received either Dupixent 300 mg weekly with TCS or Dupixent 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12% of patients receiving placebo with TCS (p<0.0001).
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64% of patients who received Dupixent 300 mg weekly with TCS, and 69% of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75, a 75% reduction on an index measuring eczema severity, compared to 23% of patients receiving placebo with TCS (p<0.0001).
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40% of patients who received Dupixent 300 mg weekly with TCS, and 36% of patients who received Dupixent 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12.5% of patients receiving placebo with TCS (p<0.0001).
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64% of patients who received 300 mg weekly with TCS, and 65% of patients who received 300 mg every two weeks with TCS achieved EASI-75, compared to 22% with placebo with TCS (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 (including CRVO and BRVO), diabetic retinopathy in patients with DME, and mCNV
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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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Brolucizumab (RTH258), 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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Lucentis
port delivery system
|
|
In development (Phase 2)
|
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Roche/Genentech
|
|
Wet AMD and related conditions
|
|
—
|
PF582, a biosimilar to Lucentis
|
|
In development (Phase 1/2)
|
|
Pfenex Inc.
|
|
Wet AMD and related conditions
|
|
—
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FYB201, a biosimilar to Lucentis
|
|
In development (Phase 3)
|
|
Formycon AG (in collaboration with Bioeq GmbH)
|
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Wet AMD and related conditions
|
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—
|
Competitor Product/Product Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
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Indication/Target
|
|
Territory
|
Repatha
®
(evolocumab)
|
|
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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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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Inclisiran (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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ETC-1002 (bempedoic acid)
|
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In development (Phase 3)
|
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Esperion Therapeutics, Inc.
|
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ACL-inhibitor
(oral, small molecule)
|
|
—
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Gemcabene
|
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In development (Phase 2)
|
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Gemphire Therapeutics Inc.
|
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Cholesterol synthesis 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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MEDI4166
|
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In development (Phase 1)
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AstraZeneca
|
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Anti-PCSK9 antibody fused to a GLP-1 peptide (injectable, biologic)
|
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—
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Regeneron Antibody
Program
|
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Competitor
|
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Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Target
|
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. (in collaboration with Vitaeris 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
|
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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
|
|
|
Roche
|
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SA 237
|
|
In development (Phase 1/Phase 3)
|
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Antibody against IL-6R
|
|
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Bird Rock Bio, Inc.
|
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Gerilimzumab
|
|
In development (Phase 2)
|
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Antibody against IL-6
|
Dupilumab (Phase 2/Phase 3)
Target: IL-4R
|
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GlaxoSmithKline
|
|
Nucala
®
(mepolizumab)
|
|
Approved
|
|
Antibody against IL-5
|
|
|
Teva
|
|
Cinqair
®
(reslizumab)
|
|
Approved
|
|
Antibody against IL-5
|
|
|
Roche
|
|
Lebrikizumab
|
|
In development (Phase 3)
|
|
Antibody against IL-13
|
|
|
AstraZeneca
|
|
Benralizumab
|
|
In development (Phase 3)
|
|
Antibody against IL-5R
|
|
|
AstraZeneca
|
|
Tralokinumab
|
|
In development (Phase 3)
|
|
Antibody against IL-13
|
|
|
Novartis
|
|
QBX258
|
|
In development (Phase 2)
|
|
Fixed dose combination of antibodies against IL-4 and IL-13
|
|
|
Galderma S.A.
|
|
Nemolizumab
|
|
In development (Phase 2)
|
|
Antibody against IL-31R
|
|
|
Amgen (in collaboration with AstraZeneca)
|
|
AMG-157
|
|
In development (Phase 2)
|
|
Antibody against TSLP
|
|
|
AstraZeneca
|
|
MEDI9314
|
|
In development (Phase 1)
|
|
Antibody against IL-4R
|
Fasinumab (Phase 2b/ Phase 3)
Target: NGF
|
|
Pfizer/Eli Lilly
|
|
Tanezumab
|
|
In development (Phase 3)
|
|
Antibody against NGF
|
REGN2222 (Phase 3)
Target: RSV-F protein
|
|
AstraZeneca
|
|
Synagis
®
(palivizumab)
|
|
Approved
|
|
Antibody against RSV-F protein
|
|
|
AstraZeneca (in collaboration with AIMM Therapeutics)
|
|
MEDI8897
|
|
In development (Phase 2b)
|
|
Antibody against RSV-F protein
|
•
|
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;
|
•
|
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;
|
•
|
our ability to meet the demand for commercial supplies of EYLEA;
|
•
|
our ability to differentiate EYLEA from Lucentis and other competitive products, 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;
|
•
|
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;
|
•
|
our ability to maintain sales of EYLEA in the face of competitive products, including those currently in clinical development;
|
•
|
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
|
•
|
risks associated with intellectual property of other parties and pending or future litigation relating thereto, as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below.
|
•
|
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;
|
•
|
our and Sanofi's ability to differentiate Praluent from Amgen's Repatha and other competitive products;
|
•
|
the outcome of the pending patent infringement proceedings initiated by Amgen against us and Sanofi (described further in Part I, Item 3. "Legal Proceedings" of this report), and other risks associated with intellectual property of other parties and pending or future litigation relating thereto, as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below;
|
•
|
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;
|
•
|
payer restrictions on eligible patient populations and the reimbursement process, both in the United States and abroad;
|
•
|
our and Sanofi's ability to maintain sales of Praluent in the face of competitive products, including Repatha
, as well as product candidates currently in clinical development;
|
•
|
the results of post-approval studies of (i) 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 (ii) other PCSK9 inhibitors, including Repatha, that could implicate an entire class of products or are perceived to do so;
|
•
|
our ability to meet the demand for commercial supplies of Praluent;
|
•
|
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
|
•
|
maintaining and successfully monitoring commercial manufacturing arrangements for Praluent with 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.
|
•
|
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;
|
•
|
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;
|
•
|
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
|
•
|
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.
|
•
|
unfamiliar foreign laws or regulatory requirements or unexpected changes to those laws or requirements;
|
•
|
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
");
|
•
|
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;
|
•
|
trading activity that results from the rebalancing of stock indices in which our Common Stock is included, or the inclusion or exclusion of our Common Stock from such indices;
|
•
|
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
10.8%
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, 2016
, and
22.0%
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, 2016
; and
|
•
|
our five largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately
52.0%
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, 2016
. In addition, these five shareholders plus our Chief Executive Officer held approximately
57.2%
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, 2016
.
|
•
|
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 shareholder 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
|
||||
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
|
|
||
|
|
|
|
|
||||
2016
|
|
|
|
|
||||
First Quarter
|
|
$
|
532.91
|
|
|
$
|
348.96
|
|
Second Quarter
|
|
433.93
|
|
|
329.09
|
|
||
Third Quarter
|
|
443.99
|
|
|
348.43
|
|
||
Fourth Quarter
|
|
452.96
|
|
|
325.35
|
|
|
12/31/2011
|
|
12/31/2012
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
||||||||||||
Regeneron
|
$
|
100.00
|
|
|
$
|
308.62
|
|
|
$
|
496.55
|
|
|
$
|
740.12
|
|
|
$
|
979.38
|
|
|
$
|
662.26
|
|
S&P 500
|
$
|
100.00
|
|
|
$
|
113.41
|
|
|
$
|
146.98
|
|
|
$
|
163.72
|
|
|
$
|
162.53
|
|
|
$
|
178.02
|
|
NQ US Pharma TR Index
|
$
|
100.00
|
|
|
$
|
114.32
|
|
|
$
|
155.11
|
|
|
$
|
188.95
|
|
|
$
|
199.22
|
|
|
$
|
197.05
|
|
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
|
|||||
|
|
|
|
|
|
|
|
|
|||||
10/1/2016-10/31/2016
|
|
184
|
|
|
$
|
371.33
|
|
|
—
|
|
|
—
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||
(In thousands, except per share data)
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
|
$
|
3,338,390
|
|
|
$
|
2,689,478
|
|
|
$
|
1,750,762
|
|
|
$
|
1,425,839
|
|
|
$
|
858,093
|
|
Sanofi and Bayer collaboration revenue
|
|
1,402,935
|
|
|
1,339,361
|
|
|
1,036,854
|
|
|
650,400
|
|
|
493,913
|
|
|||||
Other revenue
|
|
119,102
|
|
|
74,889
|
|
|
31,941
|
|
|
28,506
|
|
|
26,471
|
|
|||||
|
|
4,860,427
|
|
|
4,103,728
|
|
|
2,819,557
|
|
|
2,104,745
|
|
|
1,378,477
|
|
|||||
Expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
2,052,295
|
|
|
1,620,577
|
|
|
1,271,353
|
|
|
859,947
|
|
|
625,554
|
|
|||||
Selling, general, and administrative
|
|
1,177,697
|
|
|
838,526
|
|
|
519,267
|
|
|
346,393
|
|
|
229,859
|
|
|||||
Cost of goods sold
|
|
194,624
|
|
|
241,702
|
|
|
129,030
|
|
|
118,048
|
|
|
83,927
|
|
|||||
Cost of collaboration and contract manufacturing
|
|
105,070
|
|
|
151,007
|
|
|
75,988
|
|
|
37,307
|
|
|
528
|
|
|||||
|
|
3,529,686
|
|
|
2,851,812
|
|
|
1,995,638
|
|
|
1,361,695
|
|
|
939,868
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income from operations
|
|
1,330,741
|
|
|
1,251,916
|
|
|
823,919
|
|
|
743,050
|
|
|
438,609
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Other income (expense), net
|
|
(926
|
)
|
|
(26,819
|
)
|
|
(62,684
|
)
|
|
(46,668
|
)
|
|
(43,292
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income before income taxes
|
|
1,329,815
|
|
|
1,225,097
|
|
|
761,235
|
|
|
696,382
|
|
|
395,317
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income tax (expense) benefit
(1)
|
|
(434,293
|
)
|
|
(589,041
|
)
|
|
(423,109
|
)
|
|
(282,644
|
)
|
|
347,081
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
$
|
413,738
|
|
|
$
|
742,398
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income per share - basic
|
|
$
|
8.55
|
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
|
$
|
4.23
|
|
|
$
|
7.84
|
|
Net income per share - diluted
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
$
|
3.72
|
|
|
$
|
6.69
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
As of December 31,
|
||||||||||||||||||
(In thousands)
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents, and marketable securities (current and non-current)
|
|
$
|
1,902,944
|
|
|
$
|
1,677,385
|
|
|
$
|
1,360,634
|
|
|
$
|
1,083,875
|
|
|
$
|
587,511
|
|
Total assets
|
|
6,973,466
|
|
|
5,609,132
|
|
|
3,837,672
|
|
|
2,950,130
|
|
|
2,091,723
|
|
|||||
Convertible senior notes (current and non-current)
|
|
—
|
|
|
10,802
|
|
|
146,773
|
|
|
320,315
|
|
|
296,518
|
|
|||||
Facility lease obligations (current and non-current)
|
|
353,852
|
|
|
364,708
|
|
|
312,291
|
|
|
185,197
|
|
|
160,810
|
|
|||||
Capital lease obligations
(2)
(current and non-current)
|
|
127,274
|
|
|
—
|
|
|
—
|
|
|
126
|
|
|
1,309
|
|
|||||
Stockholders' equity
|
|
4,449,245
|
|
|
3,654,837
|
|
|
2,550,251
|
|
|
1,964,716
|
|
|
1,256,618
|
|
ITEM 7.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
|
2016 and 2017 Events to Date
|
|
2017 Plans
|
EYLEA
|
|
Bayer received regulatory approval for EYLEA for various indications and continued to pursue regulatory applications for marketing approval in additional countries
|
|
Bayer to submit for additional regulatory approvals outside the United States for various indications
|
|
|
|
Regulatory agency decisions on applications outside the United States for various indications
|
|
|
|
Initiated Phase 3 study for the treatment of NPDR in patients without DME
|
|
Continue patient enrollment in Phase 3 study for the treatment of NPDR in patients without DME
|
|
|
Reported positive top-line results from Phase 3 study in Japan for the treatment of NVG
|
|
|
|
|
2016 and 2017 Events to Date
|
|
2017 Plans
|
Praluent (PCSK9 Antibody)
|
|
Reported positive results from Phase 3 ODYSSEY ESCAPE trial
|
|
Complete ODYSSEY OUTCOMES study
|
|
|
DMC of ODYSSEY OUTCOMES study completed the first interim analysis for futility and recommended the study to continue with no changes
|
|
Submit for additional regulatory approvals outside the United States
|
|
|
Supplemental BLA for monthly dosing regimen accepted for review by the FDA
|
|
Regulatory agency and reimbursement authority decisions on applications outside the United States
|
|
|
Regulatory application filed for monthly dosing regimen in the EU
|
|
FDA target action date of April 24, 2017 for monthly dosing regimen
|
|
|
Japanese MHLW approved Praluent for the treatment of uncontrolled LDL cholesterol in certain adult patients
|
|
|
|
|
ODYSSEY study data presented at the AHA Scientific Sessions 2016
|
|
|
|
|
DMC of ODYSSEY OUTCOMES study completed the second interim analysis for futility and overwhelming efficacy and recommended the study continue as planned
|
|
|
|
|
European Commission approved 300mg every 4 week dosing regimen
|
|
|
|
|
Court issued a permanent injunction barring commercialization of Praluent in the United States beginning February 21, 2017. On February 8, 2017, an emergency motion to stay (suspend) the injunction pending appeal was granted
|
|
|
|
|
FDA extended review period for the supplemental BLA for monthly dosing regimen
|
|
|
Sarilumab (IL-6R Antibody)
|
|
Reported positive top-line results from Phase 3 SARIL-RA-MONARCH trial
|
|
Re-submission of the BLA contingent upon successful completion of FDA re-inspection of Le Trait facility
|
|
|
Regulatory applications submitted in the EU, Japan, and other jurisdictions outside the United States
|
|
Assuming successful re-submission, FDA action expected in the second quarter of 2017
|
|
|
Presented 52-week top-line data from Phase 2 SARIL-NIU-SATURN study at American Academy of Ophthalmology conference
|
|
Submit for additional regulatory approvals outside the United States
|
|
|
FDA issued CRL regarding the BLA
|
|
Regulatory agency decisions on applications outside the United States
|
|
|
Initiated Phase 2 study in pcJIA
|
|
|
|
|
Presented detailed results of SARIL-RA-MONARCH study at ACR Annual Meeting
|
|
|
|
|
Health Canada approved Kevzara
for the treatment of adult patients with RA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
•
|
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, 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
|
|
||||
Provision related to current period sales
|
93.4
|
|
|
154.4
|
|
|
30.4
|
|
|
278.2
|
|
||||
Credits/payments
|
(87.1
|
)
|
|
(173.3
|
)
|
|
(27.3
|
)
|
|
(287.7
|
)
|
||||
Balance as of December 31, 2016
|
$
|
12.7
|
|
|
$
|
29.5
|
|
|
$
|
3.6
|
|
|
$
|
45.8
|
|
Net Income
|
Year Ended December 31,
|
||||||||||
(In millions)
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues
|
$
|
4,860.4
|
|
|
$
|
4,103.7
|
|
|
$
|
2,819.6
|
|
Operating expenses
|
(3,529.7
|
)
|
|
(2,851.8
|
)
|
|
(1,995.6
|
)
|
|||
Other income (expense), net
|
(0.9
|
)
|
|
(26.8
|
)
|
|
(62.7
|
)
|
|||
Income before income taxes
|
1,329.8
|
|
|
1,225.1
|
|
|
761.3
|
|
|||
Income tax expense
|
(434.3
|
)
|
|
(589.0
|
)
|
|
(423.1
|
)
|
|||
Net income
|
$
|
895.5
|
|
|
$
|
636.1
|
|
|
$
|
338.2
|
|
|
|
|
|
|
|
||||||
Net income per share - diluted
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
Revenues
|
Year Ended December 31,
|
||||||||||
(In millions)
|
2016
|
|
2015
|
|
2014
|
||||||
Net product sales
|
$
|
3,338.4
|
|
|
$
|
2,689.5
|
|
|
$
|
1,750.8
|
|
Collaboration revenue:
|
|
|
|
|
|
||||||
Sanofi
|
658.7
|
|
|
758.9
|
|
|
541.3
|
|
|||
Bayer
|
744.3
|
|
|
580.5
|
|
|
495.6
|
|
|||
Total collaboration revenue
|
1,403.0
|
|
|
1,339.4
|
|
|
1,036.9
|
|
|||
Other revenue
|
119.0
|
|
|
74.8
|
|
|
31.9
|
|
|||
Total revenues
|
$
|
4,860.4
|
|
|
$
|
4,103.7
|
|
|
$
|
2,819.6
|
|
Sanofi Collaboration Revenue
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2016
|
|
2015
|
|
2014
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
564.9
|
|
|
$
|
735.4
|
|
|
$
|
547.8
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
322.1
|
|
|
157.4
|
|
|
19.5
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(459.1
|
)
|
|
(240.0
|
)
|
|
(41.4
|
)
|
|||
Other
|
|
12.3
|
|
|
10.2
|
|
|
10.2
|
|
|||
Total Antibody
|
|
440.2
|
|
|
663.0
|
|
|
536.1
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
138.5
|
|
|
40.0
|
|
|
—
|
|
|||
Other
|
|
80.0
|
|
|
40.0
|
|
|
—
|
|
|||
Total Immuno-oncology
|
|
218.5
|
|
|
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
|
|
$
|
658.7
|
|
|
$
|
758.9
|
|
|
$
|
541.3
|
|
Bayer Collaboration Revenue
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2016
|
|
2015
|
|
2014
|
||||||
EYLEA:
|
|
|
|
|
|
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
649.2
|
|
|
$
|
466.7
|
|
|
$
|
301.3
|
|
Sales milestones
|
|
—
|
|
|
15.0
|
|
|
105.0
|
|
|||
Cost-sharing of Regeneron EYLEA development expenses
|
|
9.0
|
|
|
8.9
|
|
|
23.4
|
|
|||
Other
|
|
52.6
|
|
|
69.4
|
|
|
52.4
|
|
|||
Total EYLEA
|
|
710.8
|
|
|
560.0
|
|
|
482.1
|
|
|||
PDGFR-beta antibody:
|
|
|
|
|
|
|
||||||
Cost-sharing of rinucumab/aflibercept development expenses
|
|
10.3
|
|
|
10.1
|
|
|
2.9
|
|
|||
Other
|
|
9.6
|
|
|
10.4
|
|
|
10.6
|
|
|||
Total PDGFR-beta antibody
|
|
19.9
|
|
|
20.5
|
|
|
13.5
|
|
|||
Ang2 antibody:
|
|
|
|
|
|
|
||||||
Cost-sharing of nesvacumab/aflibercept development expenses
|
|
8.0
|
|
|
—
|
|
|
—
|
|
|||
Other
|
|
5.6
|
|
|
—
|
|
|
—
|
|
|||
Total Ang2 antibody
|
|
13.6
|
|
|
—
|
|
|
—
|
|
|||
Total Bayer collaboration revenue
|
|
$
|
744.3
|
|
|
$
|
580.5
|
|
|
$
|
495.6
|
|
Regeneron's Net Profit from EYLEA Sales Outside the United States
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2016
|
|
2015
|
|
2014
|
||||||
Net product sales outside the United States
|
|
$
|
1,872.3
|
|
|
$
|
1,413.3
|
|
|
$
|
1,038.5
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
703.3
|
|
|
521.8
|
|
|
358.3
|
|
|||
Reimbursement of EYLEA development expenses incurred by Bayer in accordance with Regeneron's payment obligation
|
|
(54.1
|
)
|
|
(55.1
|
)
|
|
(57.0
|
)
|
|||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
649.2
|
|
|
$
|
466.7
|
|
|
$
|
301.3
|
|
Research and Development Expenses
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||||||||||
(In millions)
|
|
2016
|
|
2015
|
|
2014
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||
Payroll and benefits
(1)
|
|
$
|
597.5
|
|
|
$
|
506.3
|
|
|
$
|
401.6
|
|
|
$
|
91.2
|
|
|
$
|
104.7
|
|
Clinical trial expenses
|
|
370.6
|
|
|
306.1
|
|
|
203.0
|
|
|
64.5
|
|
|
103.1
|
|
|||||
Clinical manufacturing costs
(2)
|
|
539.2
|
|
|
431.8
|
|
|
284.8
|
|
|
107.4
|
|
|
147.0
|
|
|||||
Research, licensing, and other development costs
|
|
257.6
|
|
|
133.6
|
|
|
137.2
|
|
|
124.0
|
|
|
(3.6
|
)
|
|||||
Occupancy and other operating costs
|
|
176.4
|
|
|
136.4
|
|
|
116.5
|
|
|
40.0
|
|
|
19.9
|
|
|||||
Cost-sharing of Bayer and Sanofi development expenses
(3)
|
|
111.0
|
|
|
106.4
|
|
|
128.3
|
|
|
4.6
|
|
|
(21.9
|
)
|
|||||
Total research and development expenses
|
|
$
|
2,052.3
|
|
|
$
|
1,620.6
|
|
|
$
|
1,271.4
|
|
|
$
|
431.7
|
|
|
$
|
349.2
|
|
Project Costs
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||||||||||
(In millions)
|
|
2016
|
|
2015
|
|
2014
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||||
Praluent
|
|
$
|
154.1
|
|
|
$
|
231.0
|
|
|
$
|
316.4
|
|
|
$
|
(76.9
|
)
|
|
$
|
(85.4
|
)
|
Dupilumab
|
|
449.5
|
|
|
404.0
|
|
|
169.0
|
|
|
45.5
|
|
|
235.0
|
|
|||||
Sarilumab
|
|
59.5
|
|
|
84.6
|
|
|
86.1
|
|
|
(25.1
|
)
|
|
(1.5
|
)
|
|||||
Fasinumab
|
|
170.8
|
|
|
56.1
|
|
|
8.2
|
|
|
114.7
|
|
|
47.9
|
|
|||||
REGN2222
|
|
60.9
|
|
|
42.6
|
|
|
16.7
|
|
|
18.3
|
|
|
25.9
|
|
|||||
REGN2810
|
|
119.9
|
|
|
39.4
|
|
|
22.1
|
|
|
80.5
|
|
|
17.3
|
|
|||||
Other product candidates in clinical development
|
|
259.2
|
|
|
221.4
|
|
|
281.9
|
|
|
37.8
|
|
|
(60.5
|
)
|
|||||
Other research programs and unallocated costs
(1)
|
|
778.4
|
|
|
541.5
|
|
|
371.0
|
|
|
236.9
|
|
|
170.5
|
|
|||||
Total research and development expenses
|
|
$
|
2,052.3
|
|
|
$
|
1,620.6
|
|
|
$
|
1,271.4
|
|
|
$
|
431.7
|
|
|
$
|
349.2
|
|
|
As of December 31,
|
|
Increase
|
||||||||
(In millions)
|
2016
|
|
2015
|
|
(Decrease)
|
||||||
Financial assets:
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
535.2
|
|
|
$
|
809.1
|
|
|
$
|
(273.9
|
)
|
Marketable securities - current
|
503.5
|
|
|
236.1
|
|
|
267.4
|
|
|||
Marketable securities - non-current
|
864.2
|
|
|
632.2
|
|
|
232.0
|
|
|||
|
$
|
1,902.9
|
|
|
$
|
1,677.4
|
|
|
$
|
225.5
|
|
|
|
|
|
|
|
||||||
Borrowings:
|
|
|
|
|
|
||||||
Convertible senior notes
|
$
|
—
|
|
|
$
|
10.8
|
|
|
$
|
(10.8
|
)
|
|
|
|
|
|
|
||||||
Working capital:
|
|
|
|
|
|
||||||
Current assets
|
$
|
3,180.2
|
|
|
$
|
2,915.1
|
|
|
$
|
265.1
|
|
Current liabilities
|
1,241.5
|
|
|
811.2
|
|
|
430.3
|
|
|||
|
$
|
1,938.7
|
|
|
$
|
2,103.9
|
|
|
$
|
(165.2
|
)
|
|
|
|
|
Payments Due by Period
|
||||||||||||||||
(In millions)
|
|
Total
|
|
Less than one year
|
|
1 to 3 years
|
|
3 to 5 years
|
|
Greater than 5 years
|
||||||||||
Purchase and other obligations
(1)
|
|
$
|
1,022.6
|
|
|
$
|
579.3
|
|
|
$
|
353.4
|
|
|
$
|
42.0
|
|
|
$
|
47.9
|
|
Facility lease obligations
(2) (3)
|
|
448.5
|
|
|
32.1
|
|
|
67.1
|
|
|
70.4
|
|
|
278.9
|
|
|||||
Capital leases
(2) (3)
|
|
71.0
|
|
|
8.7
|
|
|
18.1
|
|
|
19.1
|
|
|
25.1
|
|
|||||
Operating leases
(3)
|
|
51.3
|
|
|
9.9
|
|
|
10.8
|
|
|
8.3
|
|
|
22.3
|
|
|||||
Total contractual obligations
|
|
$
|
1,593.4
|
|
|
$
|
630.0
|
|
|
$
|
449.4
|
|
|
$
|
139.8
|
|
|
$
|
374.2
|
|
(1)
|
Purchase and other obligations primarily relate to research and development commitments, including those related to clinical trials, funding in connection with our sponsorship of the Science Talent Search and other programs by the Society for Science & the Public, and capital expenditures. 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.
|
(2)
|
Represents rent payments with respect to capital lease and facility lease obligations in connection with our property leases in Tarrytown, New York, as described under "
Tarrytown, New York Leases
" above and Note 12 to our Consolidated Financial Statements. Amounts in the table above exclude (i) potential future rent payments with respect to the lease we anticipate entering into in 2017, and (ii) the potential purchase price we would be obligated to pay if the anticipated financing pursuant to the engagement letter with BAL is not obtained.
|
(3)
|
Excludes future contingent costs for utilities, real estate taxes, and operating expenses.
|
10.1.10 +
|
Amendment No. 1 to the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2013, filed February 13, 2014.)
|
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. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)
|
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. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)
|
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). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)
|
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*
|
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.)
|
10.9*
|
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.)
|
10.9.1*
|
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.)
|
10.10
|
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.)
|
10.11
|
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.)
|
10.11.1*
|
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.)
|
10.11.2
|
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.)
|
10.11.3
|
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.)
|
10.11.4
|
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.)
|
10.11.5
|
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.)
|
10.11.6
|
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.)
|
10.11.7
|
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.)
|
10.11.8
|
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.)
|
10.11.9
|
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.)
|
10.11.10
|
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.)
|
10.11.11
|
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.)
|
10.11.12
|
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.)
|
10.11.13
|
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.)
|
10.11.14
|
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.)
|
10.11.15
|
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.)
|
10.11.16
|
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.)
|
10.11.17
|
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.)
|
10.12
|
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.)
|
10.12.1
|
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.)
|
10.13*
|
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.)
|
10.13.1*
|
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.)
|
10.14*
|
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.)
|
10.14.1*
|
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.)
|
10.15*
|
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.)
|
10.15.1*
|
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.)
|
10.15.2*
|
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.)
|
10.16
|
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.)
|
10.17
|
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.)
|
10.18
|
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.)
|
10.19
|
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.)
|
10.20.1
|
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.)
|
10.20.2
|
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.)
|
10.20.3
|
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.)
|
10.20.4
|
Termination Agreement, dated as of November 23, 2016, between Goldman, Sachs & Co. and the Registrant.
|
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 Citibank, N.A. 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 Citibank, N.A. 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 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.)
|
10.22.2
|
Second Amendment, dated as of February 22, 2016, 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 March 31, 2016, filed May 5, 2016.)
|
10.22.3
|
Third Amendment, dated as of November 10, 2016, to the Master Terms and Conditions for Warrants, between Citibank, N.A. and the Registrant.
|
10.22.4
|
Termination Agreement, dated as of November 14, 2016, between Citibank, N.A. and the Registrant.
|
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 Credit Suisse International 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 Credit Suisse International 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 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.)
|
10.24.2
|
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.)
|
10.24.3
|
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.)
|
10.24.4
|
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. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)
|
10.24.5
|
Termination Agreement, dated as of November 15, 2016, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant.
|
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 Morgan Stanley & Co. International plc 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 Morgan Stanley & Co. International plc 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 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.)
|
10.26.2
|
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.)
|
10.26.3
|
Termination Agreement, dated as of November 21, 2016, between Morgan Stanley & Co. International plc and the Registrant.
|
10.27*
|
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.)
|
10.27.1*
|
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.)
|
10.27.2*
|
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.)
|
10.27.3
|
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.)
|
10.28*
|
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.)
|
10.29
|
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.)
|
10.29.1
|
Consent and Amendment No. 1 Memorandum, dated as of February 2, 2017, by and among the Registrant, as a borrower and guarantor; Regeneron Healthcare Solutions, Inc., Regeneron Genetics Center LLC, Regeneron International Unlimited Company, Regeneron Ireland Holdings Unlimited Company, Regeneron Ireland Unlimited Company, and Regeneron Capital International B.V., as subsidiary borrowers; JPMorgan Chase Bank, N.A., as administrative agent; and the lenders party thereto. (Incorporated by reference from the Form 8-K for the Registrant, filed February 7, 2017.)
|
10.30*
|
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.)
|
10.31*
|
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.)
|
10.32*
|
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.)
|
10.33*
|
ANG2 License and Collaboration Agreement, dated as of March 23, 2016, 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, 2016, filed May 5, 2016.)
|
10.34*
|
Collaboration Agreement, dated as of September 17, 2016, by and between Teva Pharmaceuticals International GmbH and Regeneron Ireland. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2016, filed November 4, 2016.)
|
10.35*
|
Purchase Agreement, dated as of December 30, 2016, by and among BMR-Landmark at Eastview LLC and BMR-Landmark at Eastview IV LLC and the Registrant.
|
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 9, 2017
|
|
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 9, 2017
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
/s/ ROBERT E. LANDRY
|
|
Senior Vice President, Finance and Chief Financial Officer (Principal Financial Officer)
|
|
February 9, 2017
|
Robert E. Landry
|
|
|
|
|
/s/ DOUGLAS S. McCORKLE
|
|
Vice President, Controller, and Assistant Treasurer (Principal Accounting Officer)
|
|
February 9, 2017
|
Douglas S. McCorkle
|
|
|
|
|
/s/ GEORGE D. YANCOPOULOS
|
|
President, Chief Scientific Officer, and Director
|
|
February 9, 2017
|
George D. Yancopoulos, M.D., Ph.D.
|
|
|
|
|
/s/ P. ROY VAGELOS
|
|
Chairman of the Board
|
|
February 9, 2017
|
P. Roy Vagelos, M.D.
|
|
|
|
|
/s/ N. ANTHONY COLES
|
|
Director
|
|
February 9, 2017
|
N. Anthony Coles, M.D.
|
|
|
|
|
/s/ CHARLES A. BAKER
|
|
Director
|
|
February 9, 2017
|
Charles A. Baker
|
|
|
|
|
/s/ BONNIE L. BASSLER
|
|
Director
|
|
February 9, 2017
|
Bonnie L. Bassler, Ph.D.
|
|
|
|
|
/s/ MICHAEL S. BROWN
|
|
Director
|
|
February 9, 2017
|
Michael S. Brown, M.D.
|
|
|
|
|
/s/ JOSEPH L. GOLDSTEIN
|
|
Director
|
|
February 9, 2017
|
Joseph L. Goldstein, M.D.
|
|
|
|
|
/s/ CHRISTINE A. POON
|
|
Director
|
|
February 9, 2017
|
Christine A. Poon
|
|
|
|
|
/s/ ARTHUR F. RYAN
|
|
Director
|
|
February 9, 2017
|
Arthur F. Ryan
|
|
|
|
|
/s/ GEORGE L. SING
|
|
Director
|
|
February 9, 2017
|
George L. Sing
|
|
|
|
|
/s/ MARC TESSIER-LAVIGNE
|
|
Director
|
|
February 9, 2017
|
Marc Tessier-Lavigne, Ph.D.
|
|
|
|
|
/s/ HUDA Y. ZOGHBI
|
|
Director
|
|
February 9, 2017
|
Huda Y. Zoghbi, M.D.
|
|
|
|
|
|
|
Page Numbers
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
535,203
|
|
|
$
|
809,102
|
|
Marketable securities
|
503,481
|
|
|
236,121
|
|
||
Accounts receivable - trade, net
|
1,343,368
|
|
|
1,152,489
|
|
||
Accounts receivable from Sanofi
|
92,989
|
|
|
153,152
|
|
||
Accounts receivable from Bayer
|
175,263
|
|
|
162,152
|
|
||
Inventories
|
399,356
|
|
|
238,578
|
|
||
Prepaid expenses and other current assets
|
130,528
|
|
|
163,501
|
|
||
Total current assets
|
3,180,188
|
|
|
2,915,095
|
|
||
|
|
|
|
||||
Marketable securities
|
864,260
|
|
|
632,162
|
|
||
Property, plant, and equipment, net
|
2,083,421
|
|
|
1,594,120
|
|
||
Deferred tax assets
|
825,303
|
|
|
461,945
|
|
||
Other assets
|
20,294
|
|
|
5,810
|
|
||
Total assets
|
$
|
6,973,466
|
|
|
$
|
5,609,132
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
879,096
|
|
|
$
|
644,112
|
|
Capital lease obligations
|
127,274
|
|
|
—
|
|
||
Deferred revenue from Sanofi, current portion
|
115,267
|
|
|
101,573
|
|
||
Deferred revenue - other, current portion
|
116,397
|
|
|
51,914
|
|
||
Other current liabilities
|
3,461
|
|
|
13,563
|
|
||
Total current liabilities
|
1,241,495
|
|
|
811,162
|
|
||
|
|
|
|
||||
Deferred revenue from Sanofi
|
503,474
|
|
|
582,664
|
|
||
Deferred revenue - other
|
327,298
|
|
|
82,015
|
|
||
Facility lease obligations
|
351,569
|
|
|
362,919
|
|
||
Other long-term liabilities
|
100,385
|
|
|
115,535
|
|
||
Total liabilities
|
2,524,221
|
|
|
1,954,295
|
|
||
|
|
|
|
||||
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 - 1,911,456 in 2016 and 1,913,776 in 2015
|
2
|
|
|
2
|
|
||
Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - 107,860,567 in 2016 and 106,378,001 in 2015
|
108
|
|
|
106
|
|
||
Additional paid-in capital
|
3,029,993
|
|
|
3,099,526
|
|
||
Retained earnings
|
1,748,222
|
|
|
852,700
|
|
||
Accumulated other comprehensive (loss) income
|
(12,840
|
)
|
|
8,572
|
|
||
Treasury Stock, at cost; 3,763,868 shares in 2016 and 3,642,820 in 2015
|
(316,240
|
)
|
|
(306,069
|
)
|
||
Total stockholders' equity
|
4,449,245
|
|
|
3,654,837
|
|
||
Total liabilities and stockholders' equity
|
$
|
6,973,466
|
|
|
$
|
5,609,132
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Statements of Operations
|
|
|
|
|
|
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Net product sales
|
|
$
|
3,338,390
|
|
|
$
|
2,689,478
|
|
|
$
|
1,750,762
|
|
Sanofi collaboration revenue
|
|
658,665
|
|
|
758,873
|
|
|
541,299
|
|
|||
Bayer collaboration revenue
|
|
744,270
|
|
|
580,488
|
|
|
495,555
|
|
|||
Other revenue
|
|
119,102
|
|
|
74,889
|
|
|
31,941
|
|
|||
|
|
4,860,427
|
|
|
4,103,728
|
|
|
2,819,557
|
|
|||
|
|
|
|
|
|
|
||||||
Expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
2,052,295
|
|
|
1,620,577
|
|
|
1,271,353
|
|
|||
Selling, general, and administrative
|
|
1,177,697
|
|
|
838,526
|
|
|
519,267
|
|
|||
Cost of goods sold
|
|
194,624
|
|
|
241,702
|
|
|
129,030
|
|
|||
Cost of collaboration and contract manufacturing
|
|
105,070
|
|
|
151,007
|
|
|
75,988
|
|
|||
|
|
3,529,686
|
|
|
2,851,812
|
|
|
1,995,638
|
|
|||
|
|
|
|
|
|
|
||||||
Income from operations
|
|
1,330,741
|
|
|
1,251,916
|
|
|
823,919
|
|
|||
|
|
|
|
|
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
||||||
Other income (expense), net
|
|
6,269
|
|
|
(12,578
|
)
|
|
(25,312
|
)
|
|||
Interest expense
|
|
(7,195
|
)
|
|
(14,241
|
)
|
|
(37,372
|
)
|
|||
|
|
(926
|
)
|
|
(26,819
|
)
|
|
(62,684
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income before income taxes
|
|
1,329,815
|
|
|
1,225,097
|
|
|
761,235
|
|
|||
|
|
|
|
|
|
|
||||||
Income tax expense
|
|
(434,293
|
)
|
|
(589,041
|
)
|
|
(423,109
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
8.55
|
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
Net income per share - diluted
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
|
104,719
|
|
|
103,061
|
|
|
100,612
|
|
|||
Weighted average shares outstanding - diluted
|
|
116,367
|
|
|
115,230
|
|
|
113,413
|
|
|||
|
|
|
|
|
|
|
||||||
Statements of Comprehensive Income
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
||||||
Unrealized (loss) gain on marketable securities, net of tax
|
|
(21,412
|
)
|
|
(43,679
|
)
|
|
53,439
|
|
|||
Comprehensive income
|
|
$
|
874,110
|
|
|
$
|
592,377
|
|
|
$
|
391,565
|
|
|
|
|
|
|
|
|
||||||
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, 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
|
|
|||||||
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
|
)
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|||||||||||||||||||||
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
|
)
|
|||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
636,056
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
636,056
|
|
|||||||
Other comprehensive loss, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(43,679
|
)
|
|
(43,679
|
)
|
|||||||
Balance, December 31, 2015
|
|
1,913
|
|
|
2
|
|
|
106,378
|
|
|
106
|
|
|
3,099,526
|
|
|
852,700
|
|
|
(3,643
|
)
|
|
(306,069
|
)
|
|
8,572
|
|
|
3,654,837
|
|
|||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
1,697
|
|
|
2
|
|
|
115,180
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
115,182
|
|
|||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(382
|
)
|
|
—
|
|
|
(143,182
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(143,182
|
)
|
|||||||
Issuance of Common Stock in connection with conversion of convertible senior notes
|
|
—
|
|
|
—
|
|
|
121
|
|
|
—
|
|
|
48,004
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
48,004
|
|
|||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
|
|
—
|
|
|
—
|
|
|
27
|
|
|
—
|
|
|
16,561
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16,561
|
|
|||||||
Issuance of restricted Common Stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
17
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Conversion of Class A Stock to Common Stock
|
|
(2
|
)
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
104,745
|
|
|
74,909
|
|
|
52,686
|
|
|||
Non-cash compensation expense
|
|
559,878
|
|
|
459,049
|
|
|
321,750
|
|
|||
Other non-cash charges and expenses, net
|
|
45,139
|
|
|
52,562
|
|
|
77,571
|
|
|||
Deferred taxes
|
|
(360,078
|
)
|
|
(121,623
|
)
|
|
(53,276
|
)
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Increase in Sanofi, Bayer, and trade accounts receivable
|
|
(143,827
|
)
|
|
(491,421
|
)
|
|
(34,927
|
)
|
|||
Increase in inventories
|
|
(149,776
|
)
|
|
(111,825
|
)
|
|
(56,947
|
)
|
|||
Decrease (increase) in prepaid expenses and other assets
|
|
23,543
|
|
|
(79,476
|
)
|
|
(45,327
|
)
|
|||
Increase (decrease) in deferred revenue
|
|
244,270
|
|
|
608,892
|
|
|
(8,403
|
)
|
|||
Increase in accounts payable, accrued expenses, and other liabilities
|
|
253,980
|
|
|
303,657
|
|
|
161,182
|
|
|||
Total adjustments
|
|
577,874
|
|
|
694,724
|
|
|
414,309
|
|
|||
Net cash provided by operating activities
|
|
1,473,396
|
|
|
1,330,780
|
|
|
752,435
|
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
|
(809,419
|
)
|
|
(557,105
|
)
|
|
(564,188
|
)
|
|||
Sales or maturities of marketable securities
|
|
274,456
|
|
|
327,437
|
|
|
476,417
|
|
|||
Capital expenditures
|
|
(511,941
|
)
|
|
(677,933
|
)
|
|
(333,006
|
)
|
|||
Net cash used in investing activities
|
|
(1,046,904
|
)
|
|
(907,601
|
)
|
|
(420,777
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||||||
(Payments) proceeds in connection with capital and facility lease obligations
|
|
(27,689
|
)
|
|
26,020
|
|
|
(1,095
|
)
|
|||
Repayments of convertible senior notes
|
|
(12,894
|
)
|
|
(166,467
|
)
|
|
(220,639
|
)
|
|||
Payments in connection with reduction of outstanding warrants
|
|
(643,365
|
)
|
|
(573,487
|
)
|
|
(294,552
|
)
|
|||
Proceeds from issuance of Common Stock
|
|
126,739
|
|
|
206,358
|
|
|
126,045
|
|
|||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(143,182
|
)
|
|
(160,537
|
)
|
|
(267,584
|
)
|
|||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
405,317
|
|
|
439,278
|
|
|||
Net cash used in financing activities
|
|
(700,391
|
)
|
|
(262,796
|
)
|
|
(218,547
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net (decrease) increase in cash and cash equivalents
|
|
(273,899
|
)
|
|
160,383
|
|
|
113,111
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at beginning of period
|
|
809,102
|
|
|
648,719
|
|
|
535,608
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at end of period
|
|
$
|
535,203
|
|
|
$
|
809,102
|
|
|
$
|
648,719
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest (net of amounts capitalized)
|
|
$
|
5,454
|
|
|
$
|
10,582
|
|
|
$
|
20,348
|
|
Cash paid for income taxes
|
|
$
|
481,360
|
|
|
$
|
276,092
|
|
|
$
|
59,847
|
|
|
|
|
|
|
|
|
||||||
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 the EU, Japan, and certain other countries outside the United States for the treatment of myopic choroidal neovascularization (mCNV) and in the United States for the treatment of diabetic retinopathy in patients with DME. The Company is collaborating with Bayer on the development and commercialization of EYLEA outside the United States.
|
•
|
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 low-density lipoprotein ("LDL") cholesterol. Praluent is also available in certain countries in Europe 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. In July 2016, the Japanese Ministry of Health, Labour and Welfare ("MHLW") granted marketing and manufacturing authorization for Praluent for the treatment of uncontrolled LDL cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. The Company is collaborating with Sanofi on the global development and commercialization of Praluent. See Note 17 for information regarding the patent infringement proceedings relating to Praluent, which may impact Praluent's commercial availability in the United States and other jurisdictions.
|
•
|
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.
|
•
|
Kevzara
TM
(sarilumab) Solution for Subcutaneous Injection
. In January 2017, Health Canada approved Kevraza for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to or intolerance to one or more biologic or non-biologic disease modifying anti-rheumatic drugs ("DMARDs"). This is the first approval of Kevzara worldwide.
|
•
|
ZALTRAP
®
(ziv-aflibercept) Injection for Intravenous Infusion
, known in the scientific literature as VEGF Trap, which is available in the United States, EU, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan ("FOLFIRI"), of patients with metastatic colorectal cancer ("mCRC") that is resistant to or has progressed following an oxaliplatin-containing regimen. Pursuant to a 2015 amended and restated ZALTRAP agreement ("Amended ZALTRAP Agreement"), Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays the Company a percentage of aggregate net sales of ZALTRAP.
|
•
|
Included in Sanofi collaboration revenue is the Company's share of profits or losses from commercialization of antibodies, which is provided by Sanofi, and includes an estimate of the Company's share of profits or losses for the most recent fiscal quarter.
|
•
|
Included in Bayer collaboration revenue is the Company's share of profits or losses from commercialization of EYLEA outside the United States, which is provided by Bayer, 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 and Sanofi, including the Company's share of Bayer and Sanofi estimated development expenses for the most recent fiscal quarter.
|
Building and improvements
|
|
10-40 years
|
Laboratory and other equipment
|
|
3-10 years
|
Furniture and fixtures
|
|
5 years
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Besse Medical, a subsidiary of AmerisourceBergen Corporation
|
55
|
%
|
|
67
|
%
|
|
73
|
%
|
McKesson Corporation
|
28
|
%
|
|
26
|
%
|
|
20
|
%
|
Curascript SD Specialty Distribution, a subsidiary of Express Scripts
|
16
|
%
|
|
**
|
|
|
**
|
|
|
Rebates &
Chargebacks
|
|
Distribution-
Related
Fees
|
|
Other Sales-
Related
Deductions
|
|
Total
|
||||||||
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
|
|
||||
Provision related to current period sales
|
93,385
|
|
|
154,477
|
|
|
30,442
|
|
|
278,304
|
|
||||
Credits/payments
|
(87,092
|
)
|
|
(173,325
|
)
|
|
(27,285
|
)
|
|
(287,702
|
)
|
||||
Balance as of December 31, 2016
|
$
|
12,712
|
|
|
$
|
29,465
|
|
|
$
|
3,674
|
|
|
$
|
45,851
|
|
|
|
Year Ended December 31,
|
||||||||||
Sanofi Collaboration Revenue
|
|
2016
|
|
2015
|
|
2014
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
564,900
|
|
|
$
|
735,439
|
|
|
$
|
547,761
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
322,149
|
|
|
157,350
|
|
|
19,480
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(459,058
|
)
|
|
(240,042
|
)
|
|
(41,378
|
)
|
|||
Other
|
|
12,177
|
|
|
10,243
|
|
|
10,243
|
|
|||
Total Antibody
|
|
440,168
|
|
|
662,990
|
|
|
536,106
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
138,497
|
|
|
39,961
|
|
|
—
|
|
|||
Other
|
|
80,000
|
|
|
40,000
|
|
|
—
|
|
|||
Total Immuno-oncology
|
|
218,497
|
|
|
79,961
|
|
|
—
|
|
|||
ZALTRAP:
|
|
|
|
|
|
|
||||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
—
|
|
|
—
|
|
|
(4,715
|
)
|
|||
Reimbursement of Regeneron research and development expenses
|
|
—
|
|
|
686
|
|
|
4,806
|
|
|||
Other
|
|
—
|
|
|
15,236
|
|
|
5,102
|
|
|||
Total ZALTRAP
|
|
—
|
|
|
15,922
|
|
|
5,193
|
|
|||
|
|
$
|
658,665
|
|
|
$
|
758,873
|
|
|
$
|
541,299
|
|
|
|
As of December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Antibody:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
47,268
|
|
|
$
|
126,687
|
|
Deferred revenue
|
|
98,741
|
|
|
84,237
|
|
||
|
|
|
|
|
||||
Immuno-oncology:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
40,647
|
|
|
$
|
21,394
|
|
Deferred revenue
|
|
520,000
|
|
|
600,000
|
|
|
|
Year Ended December 31,
|
||||||||||
Bayer Collaboration Revenue
|
|
2016
|
|
2015
|
|
2014
|
||||||
EYLEA:
|
|
|
|
|
|
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
649,232
|
|
|
$
|
466,667
|
|
|
$
|
301,302
|
|
Sales milestones
|
|
—
|
|
|
15,000
|
|
|
105,000
|
|
|||
Cost-sharing of Regeneron EYLEA development expenses
|
|
9,010
|
|
|
8,887
|
|
|
23,383
|
|
|||
Other
|
|
52,527
|
|
|
69,466
|
|
|
52,390
|
|
|||
Total EYLEA
|
|
710,769
|
|
|
560,020
|
|
|
482,075
|
|
|||
PDGFR-beta antibody:
|
|
|
|
|
|
|
||||||
Cost-sharing of rinucumab/aflibercept (REGN2176-3) development expenses
|
|
10,291
|
|
|
10,075
|
|
|
2,848
|
|
|||
Other
|
|
9,576
|
|
|
10,393
|
|
|
10,632
|
|
|||
Total PDGFR-beta antibody
|
|
19,867
|
|
|
20,468
|
|
|
13,480
|
|
|||
Ang2 antibody:
|
|
|
|
|
|
|
||||||
Cost-sharing of nesvacumab/aflibercept (REGN910-3) development expenses
|
|
8,036
|
|
|
—
|
|
|
—
|
|
|||
Other
|
|
5,598
|
|
|
—
|
|
|
—
|
|
|||
Total Ang2 antibody
|
|
13,634
|
|
|
—
|
|
|
—
|
|
|||
|
|
$
|
744,270
|
|
|
$
|
580,488
|
|
|
$
|
495,555
|
|
|
|
As of December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
EYLEA
|
|
$
|
62,373
|
|
|
$
|
46,694
|
|
PDGFR-beta antibody
|
|
—
|
|
|
9,522
|
|
||
Ang2 antibody
|
|
45,739
|
|
|
—
|
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
As of December 31, 2016
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate bonds
|
|
$
|
1,076,964
|
|
|
$
|
630
|
|
|
$
|
(4,743
|
)
|
|
$
|
1,072,851
|
|
U.S. government and government agency obligations
|
|
132,923
|
|
|
58
|
|
|
(641
|
)
|
|
132,340
|
|
||||
Municipal bonds
|
|
7,663
|
|
|
1
|
|
|
(20
|
)
|
|
7,644
|
|
||||
Commercial paper
|
|
63,074
|
|
|
1
|
|
|
—
|
|
|
63,075
|
|
||||
Certificates of deposit
|
|
42,612
|
|
|
—
|
|
|
—
|
|
|
42,612
|
|
||||
Equity securities
|
|
57,251
|
|
|
5,551
|
|
|
(13,583
|
)
|
|
49,219
|
|
||||
|
|
$
|
1,380,487
|
|
|
$
|
6,241
|
|
|
$
|
(18,987
|
)
|
|
$
|
1,367,741
|
|
As of December 31, 2015
|
|
|
|
|
|
|
|
|
||||||||
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
|
|
|
14,462
|
|
|
—
|
|
|
31,467
|
|
||||
|
|
$
|
856,429
|
|
|
$
|
14,623
|
|
|
$
|
(2,769
|
)
|
|
$
|
868,283
|
|
|
|
As of December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Maturities within one year
|
|
$
|
503,482
|
|
|
$
|
236,121
|
|
Maturities after one year through five years
|
|
815,040
|
|
|
600,695
|
|
||
|
|
$
|
1,318,522
|
|
|
$
|
836,816
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
As of December 31, 2016
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
$
|
759,222
|
|
|
$
|
(4,685
|
)
|
|
$
|
36,407
|
|
|
$
|
(58
|
)
|
|
$
|
795,629
|
|
|
$
|
(4,743
|
)
|
U.S. government and government agency obligations
|
81,170
|
|
|
(641
|
)
|
|
—
|
|
|
—
|
|
|
81,170
|
|
|
(641
|
)
|
||||||
Municipal bonds
|
7,141
|
|
|
(20
|
)
|
|
—
|
|
|
—
|
|
|
7,141
|
|
|
(20
|
)
|
||||||
Equity securities
|
36,417
|
|
|
(13,583
|
)
|
|
—
|
|
|
—
|
|
|
36,417
|
|
|
(13,583
|
)
|
||||||
|
$
|
883,950
|
|
|
$
|
(18,929
|
)
|
|
$
|
36,407
|
|
|
$
|
(58
|
)
|
|
$
|
920,357
|
|
|
$
|
(18,987
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
As of December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
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
|
)
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||
As of December 31, 2016
|
Fair Value
|
|
Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
1,072,851
|
|
|
—
|
|
|
$
|
1,072,851
|
|
|
U.S. government and government agency obligations
|
132,340
|
|
|
—
|
|
|
132,340
|
|
|||
Municipal bonds
|
7,644
|
|
|
—
|
|
|
7,644
|
|
|||
Commercial paper
|
63,075
|
|
|
—
|
|
|
63,075
|
|
|||
Certificates of deposit
|
42,612
|
|
|
—
|
|
|
42,612
|
|
|||
Equity securities
|
49,219
|
|
|
$
|
49,219
|
|
|
—
|
|
||
|
$
|
1,367,741
|
|
|
$
|
49,219
|
|
|
$
|
1,318,522
|
|
|
|
|
|
|
|
||||||
As of December 31, 2015
|
|
|
|
|
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
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
|
31,467
|
|
|
$
|
31,467
|
|
|
—
|
|
||
|
$
|
868,283
|
|
|
$
|
31,467
|
|
|
$
|
836,816
|
|
|
As of December 31,
|
||||||
|
2016
|
|
2015
|
||||
Raw materials
|
$
|
92,287
|
|
|
$
|
59,151
|
|
Work-in-process
|
202,301
|
|
|
132,068
|
|
||
Finished goods
|
13,334
|
|
|
11,197
|
|
||
Deferred costs
|
91,434
|
|
|
36,162
|
|
||
|
$
|
399,356
|
|
|
$
|
238,578
|
|
|
As of December 31,
|
||||||
|
2016
|
|
2015
|
||||
Land
|
$
|
103,906
|
|
|
$
|
77,826
|
|
Building and improvements
|
1,278,283
|
|
|
760,517
|
|
||
Leasehold improvements
|
101,101
|
|
|
95,226
|
|
||
Construction-in-progress
|
318,929
|
|
|
579,834
|
|
||
Laboratory and other equipment
|
554,181
|
|
|
330,432
|
|
||
Furniture, computer and office equipment, and other
|
152,525
|
|
|
81,381
|
|
||
|
2,508,925
|
|
|
1,925,216
|
|
||
Less, accumulated depreciation and amortization
|
(425,504
|
)
|
|
(331,096
|
)
|
||
|
$
|
2,083,421
|
|
|
$
|
1,594,120
|
|
|
As of December 31,
|
||||||
|
2016
|
|
2015
|
||||
Accounts payable
|
$
|
134,984
|
|
|
$
|
140,962
|
|
Accrued payroll and related costs
|
153,086
|
|
|
133,223
|
|
||
Accrued clinical trial expense
|
91,753
|
|
|
88,297
|
|
||
Accrued sales-related charges, deductions, and royalties
|
159,985
|
|
|
195,986
|
|
||
Income taxes payable
|
235,776
|
|
|
—
|
|
||
Other accrued expenses and liabilities
|
103,512
|
|
|
85,644
|
|
||
|
$
|
879,096
|
|
|
$
|
644,112
|
|
|
As of December 31,
|
||||||
|
2016
|
|
2015
|
||||
Current portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
115,267
|
|
|
$
|
101,573
|
|
Received or receivable from Bayer (see Note 3b)
|
31,084
|
|
|
24,290
|
|
||
Received or receivable from MTPC (see Note 3c)
|
9,188
|
|
|
2,352
|
|
||
Received or receivable from Teva (see Note 3d)
|
43,122
|
|
|
—
|
|
||
Received for technology license agreement (see Note 4)
|
23,572
|
|
|
23,572
|
|
||
Other
|
9,431
|
|
|
1,700
|
|
||
|
$
|
231,664
|
|
|
$
|
153,487
|
|
Long-term portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
503,474
|
|
|
$
|
582,664
|
|
Received or receivable from Bayer (see Note 3b)
|
77,028
|
|
|
31,926
|
|
||
Received or receivable from MTPC (see Note 3c)
|
45,940
|
|
|
7,059
|
|
||
Received or receivable from Teva (see Note 3d)
|
194,050
|
|
|
—
|
|
||
Received for technology license agreement (see Note 4)
|
10,280
|
|
|
33,851
|
|
||
Other
|
—
|
|
|
9,179
|
|
||
|
$
|
830,772
|
|
|
$
|
664,679
|
|
|
|
As of December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Total convertible senior notes - par
|
|
$
|
—
|
|
|
$
|
11,154
|
|
Unamortized discount
|
|
—
|
|
|
(352
|
)
|
||
|
|
$
|
—
|
|
|
$
|
10,802
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Contractual coupon interest rate
|
|
$
|
7
|
|
|
$
|
544
|
|
|
$
|
5,036
|
|
Amortization of discount and note issuance costs
|
|
150
|
|
|
2,818
|
|
|
17,821
|
|
|||
|
|
$
|
157
|
|
|
$
|
3,362
|
|
|
$
|
22,857
|
|
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2017
|
|
$
|
4,728
|
|
|
$
|
5,156
|
|
|
$
|
9,884
|
|
2018
|
|
4,860
|
|
|
825
|
|
|
5,685
|
|
|||
2019
|
|
4,817
|
|
|
273
|
|
|
5,090
|
|
|||
2020
|
|
4,271
|
|
|
12
|
|
|
4,283
|
|
|||
2021
|
|
3,982
|
|
|
11
|
|
|
3,993
|
|
|||
Thereafter
|
|
22,336
|
|
|
—
|
|
|
22,336
|
|
|||
|
|
$
|
44,994
|
|
|
$
|
6,277
|
|
|
$
|
51,271
|
|
Year Ended December 31,
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2016
|
|
$
|
15,861
|
|
|
$
|
852
|
|
|
$
|
16,713
|
|
2015
|
|
14,659
|
|
|
543
|
|
|
15,202
|
|
|||
2014
|
|
13,360
|
|
|
952
|
|
|
14,312
|
|
|
|
Buildings A and B
|
|
Building C
|
|
Buildings D and E
|
|
Building F
|
|
Total
|
||||||||||
2017
|
|
$
|
13,965
|
|
|
$
|
4,740
|
|
|
$
|
12,922
|
|
|
$
|
490
|
|
|
$
|
32,117
|
|
2018
|
|
14,242
|
|
|
4,873
|
|
|
13,267
|
|
|
759
|
|
|
33,141
|
|
|||||
2019
|
|
14,526
|
|
|
5,009
|
|
|
13,621
|
|
|
786
|
|
|
33,942
|
|
|||||
2020
|
|
14,818
|
|
|
5,149
|
|
|
13,983
|
|
|
813
|
|
|
34,763
|
|
|||||
2021
|
|
15,116
|
|
|
5,292
|
|
|
14,354
|
|
|
841
|
|
|
35,603
|
|
|||||
Thereafter
|
|
101,010
|
|
|
48,801
|
|
|
121,927
|
|
|
7,190
|
|
|
278,928
|
|
|||||
|
|
$
|
173,677
|
|
|
$
|
73,864
|
|
|
$
|
190,074
|
|
|
$
|
10,879
|
|
|
$
|
448,494
|
|
a.
|
Stock Options
|
Stock Options:
|
|
Number of Shares
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term (in years)
|
|
Intrinsic Value
|
||||||
Outstanding as of December 31, 2015
|
|
23,165,769
|
|
|
$
|
236.75
|
|
|
|
|
|
|
||
2016:
|
Granted
|
|
4,201,978
|
|
|
$
|
386.44
|
|
|
|
|
|
||
|
Forfeited
|
|
(468,798
|
)
|
|
$
|
398.57
|
|
|
|
|
|
||
|
Expired
|
|
(20,645
|
)
|
|
$
|
420.04
|
|
|
|
|
|
||
|
Exercised
|
|
(1,742,277
|
)
|
|
$
|
76.79
|
|
|
|
|
|
||
Outstanding as of December 31, 2016
|
|
25,136,027
|
|
|
$
|
269.69
|
|
|
6.66
|
|
$
|
3,399,815
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vested and expected to vest as of December 31, 2016
|
|
24,598,430
|
|
|
$
|
266.16
|
|
|
6.60
|
|
$
|
3,397,437
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable as of December 31, 2016
|
|
15,140,287
|
|
|
$
|
166.96
|
|
|
5.19
|
|
$
|
3,299,296
|
|
|
|
Number of Options Granted
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Fair Value
|
|||||
2016:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
4,201,978
|
|
|
$
|
386.44
|
|
|
$
|
126.68
|
|
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
|
|
|
|
2016
|
|
2015
|
|
2014
|
|||
Expected volatility
|
|
34
|
%
|
|
35
|
%
|
|
39
|
%
|
Expected lives from grant date
|
|
5.1 years
|
|
|
5.1 years
|
|
|
5.2 years
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk-free interest rate
|
|
1.84
|
%
|
|
1.68
|
%
|
|
1.62
|
%
|
b.
|
Restricted Stock
|
Restricted Stock:
|
|
Number of Shares
|
|
Weighted-Average Grant Date Fair Value
|
||||
Outstanding as of December 31, 2015
|
|
541,700
|
|
|
$
|
133.96
|
|
|
2016:
|
Granted
|
|
16,750
|
|
|
$
|
385.84
|
|
|
Vested
|
|
(11,590
|
)
|
|
$
|
125.38
|
|
|
Forfeited
|
|
(40
|
)
|
|
$
|
237.68
|
|
Outstanding as of December 31, 2016
|
|
546,820
|
|
|
$
|
141.85
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
United States
|
$
|
1,650,959
|
|
|
$
|
1,665,087
|
|
|
$
|
1,101,446
|
|
|
Foreign
|
(321,144
|
)
|
|
(439,990
|
)
|
|
(340,211
|
)
|
||||
|
|
$
|
1,329,815
|
|
|
$
|
1,225,097
|
|
|
$
|
761,235
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Current:
|
|
|
|
|
|
|||||||
|
Federal
|
$
|
786,964
|
|
|
$
|
686,561
|
|
|
$
|
437,038
|
|
|
State
|
8,769
|
|
|
28,568
|
|
|
28,718
|
|
|||
|
Foreign
|
(1,362
|
)
|
|
4,004
|
|
|
2,879
|
|
|||
|
Total current tax expense
|
794,371
|
|
|
719,133
|
|
|
468,635
|
|
|||
Deferred:
|
|
|
|
|
|
|||||||
|
Federal
|
(377,368
|
)
|
|
(119,849
|
)
|
|
(62,932
|
)
|
|||
|
State
|
13,431
|
|
|
(3,768
|
)
|
|
18,891
|
|
|||
|
Foreign
|
3,859
|
|
|
(6,475
|
)
|
|
(1,485
|
)
|
|||
|
Total deferred tax (benefit) expense
|
(360,078
|
)
|
|
(130,092
|
)
|
|
(45,526
|
)
|
|||
|
$
|
434,293
|
|
|
$
|
589,041
|
|
|
$
|
423,109
|
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
U.S. federal statutory tax rate
|
35.0
|
%
|
|
35.0
|
%
|
|
35.0
|
%
|
Stock-based compensation
|
(10.9
|
)
|
|
—
|
|
|
—
|
|
State and local income taxes
|
0.3
|
|
|
1.0
|
|
|
2.4
|
|
Change in state effective rate
|
1.0
|
|
|
(0.1
|
)
|
|
2.9
|
|
Foreign income tax rate differential
|
8.8
|
|
|
12.2
|
|
|
15.8
|
|
Income tax credits
|
(1.2
|
)
|
|
(1.6
|
)
|
|
(5.1
|
)
|
Non-deductible Branded Prescription Drug Fee
|
1.9
|
|
|
2.0
|
|
|
2.8
|
|
Domestic production activities deduction
|
(2.8
|
)
|
|
(3.2
|
)
|
|
—
|
|
Other permanent differences
|
0.6
|
|
|
2.8
|
|
|
1.8
|
|
Effective income tax rate
|
32.7
|
%
|
|
48.1
|
%
|
|
55.6
|
%
|
|
|
As of December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating loss carryforward
|
|
$
|
137
|
|
|
$
|
140
|
|
Fixed and intangible assets
|
|
21,139
|
|
|
—
|
|
||
Deferred revenue
|
|
214,587
|
|
|
51,766
|
|
||
Deferred compensation
|
|
515,984
|
|
|
349,508
|
|
||
Capitalized research and development costs
|
|
2,492
|
|
|
7,725
|
|
||
Accrued expenses
|
|
37,188
|
|
|
47,520
|
|
||
Other
|
|
46,471
|
|
|
26,580
|
|
||
|
|
837,998
|
|
|
483,239
|
|
||
Valuation allowance
|
|
(3,420
|
)
|
|
—
|
|
||
Total deferred tax assets
|
|
834,578
|
|
|
483,239
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
||||
Unrealized gains/losses on marketable securities
|
|
—
|
|
|
(3,280
|
)
|
||
Fixed assets and intangible assets
|
|
—
|
|
|
(5,559
|
)
|
||
Other
|
|
(9,275
|
)
|
|
(12,455
|
)
|
||
Total deferred tax liabilities
|
|
(9,275
|
)
|
|
(21,294
|
)
|
||
Net deferred tax assets
|
|
$
|
825,303
|
|
|
$
|
461,945
|
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Balance as of January 1
|
|
$
|
116,572
|
|
|
$
|
57,615
|
|
|
$
|
26,627
|
|
Gross increases related to current year tax positions
|
|
45,575
|
|
|
59,909
|
|
|
27,538
|
|
|||
Gross (decreases) increases related to prior year tax positions
|
|
(42,284
|
)
|
|
(952
|
)
|
|
6,464
|
|
|||
Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation
|
|
(2,697
|
)
|
|
—
|
|
|
(3,014
|
)
|
|||
Balance as of December 31
|
|
$
|
117,166
|
|
|
$
|
116,572
|
|
|
$
|
57,615
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Net income - basic
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Convertible senior notes - interest expense related to contractual coupon interest rate and amortization of discount and note issuance costs
|
|
397
|
|
|
—
|
|
|
—
|
|
|||
Net income - diluted
|
|
$
|
895,919
|
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
|
|
|
|
|
|
||||||
(Shares in thousands)
|
|
|
|
|
|
|
||||||
Weighted average shares - basic
|
|
104,719
|
|
|
103,061
|
|
|
100,612
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
10,177
|
|
|
9,446
|
|
|
9,440
|
|
|||
Restricted stock
|
|
474
|
|
|
477
|
|
|
425
|
|
|||
Convertible senior notes
|
|
61
|
|
|
—
|
|
|
—
|
|
|||
Warrants
|
|
936
|
|
|
2,246
|
|
|
2,936
|
|
|||
Dilutive potential shares
|
|
11,648
|
|
|
12,169
|
|
|
12,801
|
|
|||
Weighted average shares - diluted
|
|
116,367
|
|
|
115,230
|
|
|
113,413
|
|
|||
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
8.55
|
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
Net income per share - diluted
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
|
Year Ended December 31,
|
|||||||
(Shares in thousands)
|
|
2016
|
|
2015
|
|
2014
|
|||
Stock options
|
|
8,041
|
|
|
1,343
|
|
|
1,470
|
|
Restricted stock
|
|
19
|
|
|
—
|
|
|
—
|
|
Convertible senior notes
|
|
—
|
|
|
994
|
|
|
4,247
|
|
|
|
First Quarter Ended
March 31, 2016
*
|
|
Second Quarter Ended
June 30, 2016
|
|
Third Quarter Ended
September 30, 2016
|
|
Fourth Quarter Ended
December 31, 2016
|
||||||||
|
|
(Unaudited)
|
||||||||||||||
Revenues
|
|
$
|
1,200,849
|
|
|
$
|
1,212,629
|
|
|
$
|
1,220,122
|
|
|
$
|
1,226,827
|
|
Net income
|
|
$
|
181,385
|
|
|
$
|
196,218
|
|
|
$
|
264,804
|
|
|
$
|
253,115
|
|
Net income per share - basic
|
|
$
|
1.74
|
|
|
$
|
1.88
|
|
|
$
|
2.53
|
|
|
$
|
2.41
|
|
Net income per share - diluted
|
|
$
|
1.59
|
|
|
$
|
1.69
|
|
|
$
|
2.27
|
|
|
$
|
2.19
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
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
|
|
|
|
November 25, 2016 Settlement
|
|
|
|
Applicable Number of Warrants:
|
194,777
|
First Termination Payment Amount:
|
USD 58,902,512.57
|
Payment Date:
|
November 25, 2016
|
|
|
November 28, 2016 Settlement
|
|
|
|
Applicable Number of Warrants:
|
197,477
|
First Termination Payment Amount:
|
USD 58,530,208.03
|
Payment Date:
|
November 28, 2016
|
|
|
November 29, 2016 Settlement
|
|
|
|
Applicable Number of Warrants:
|
197,997
|
First Termination Payment Amount:
|
USD 58,753,629.78
|
Payment Date:
|
November 29, 2016
|
GOLDMAN, SACHS & CO.
|
|
|
|
By:
|
/s/Daniela A. Rouse
|
Name:
|
Daniela A. Rouse
|
Title:
|
Vice President
|
|
|
Agreed and Accepted By:
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
By:
|
/s/Dominick Agron
|
Name:
|
Dominick Agron
|
Title:
|
Vice President and Treasurer
|
Date:
|
November 10, 2016
|
|
|
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
|
|
|
From:
|
Citibank, N.A.
|
|
390 Greenwich Street
|
|
New York, NY 10013
|
|
|
Attention:
|
James Heathcote
|
|
Corporate Equity Derivatives
|
|
390 Greenwich Street
|
|
New York, NY 10013
|
|
|
Re:
|
Third Amendment of the Warrant Transaction between Citibank, N.A. and Regeneron Pharmaceuticals, Inc. (this “
Amendment
”)
|
November 10, 2016 Settlement:
|
|
Applicable Number of Warrants:
|
125,000
|
Amendment Payment:
|
USD 32,108,750.00
|
Payment Date:
|
November 10, 2016
|
|
|
November 14, 2016 Settlement:
|
|
Applicable Number of Warrants:
|
176,293
|
Amendment Payment:
|
USD 47,241,235.21
|
Payment Date:
|
November 14, 2016
|
|
|
November 15, 2016 Settlement:
|
|
Applicable Number of Warrants:
|
80,000
|
Amendment Payment:
|
USD 24,463,200.00
|
Payment Date:
|
November 15, 2016
|
CITIBANK, N.A.
|
|
|
|
By:
|
/s/Herman Hirsch
|
Name:
|
Herman Hirsch
|
Title:
|
Authorized Representative
|
|
|
Agreed and Accepted By:
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
By:
|
/s/Dominick Agron
|
Name:
|
Dominick Agron
|
Title:
|
Vice President and Treasurer
|
Termination Payment Amount:
|
USD 74,908,135.55
|
|
|
Payment Date:
|
November 17, 2016
|
CITIBANK, N.A.
|
|
|
|
By:
|
/s/James Heathcote
|
|
Name: James Heathcote
|
|
Title: Authorized Signatory
|
|
|
Agreed and Accepted By:
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
By:
|
/s/Dominick Agron
|
|
Name: Dominick Agron
|
|
Title: Vice President & Treasurer
|
Termination Payment Amount:
|
USD 12,873,684.18
|
|
|
Payment Date:
|
November 18, 2016
|
CREDIT SUISSE CAPITAL LLC
|
|
|
|
By:
|
/s/Carole Villoresi
|
|
Name: Carole Villoresi
|
|
Title: Authorized Signatory
|
|
|
By:
|
/s/Shui Wong
|
|
Name: Shui Wong
|
|
Title: Authorized Signatory
|
|
|
CREDIT SUISSE SECURITIES (USA) LLC, as agent for Credit Suisse Capital LLC
|
|
|
|
By:
|
/s/Carole Villoresi
|
|
Name: Carole Villoresi
|
|
Title: Vice President
|
|
|
Agreed and Accepted By:
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
By:
|
/s/Dominick Agron
|
|
Name: Dominick Agron
|
|
Title: Vice President & Treasurer
|
Termination Payment Amount:
|
USD $33,465,723.78
|
|
|
Payment Date:
|
November 23, 2016
|
MORGAN STANLEY & CO. INTERNATIONAL PLC
|
|
|
|
By:
|
/s/Stefan Ploetscher
|
|
Name: Stefan Ploetscher
|
|
Title: Executive Director
|
|
|
MORGAN STANLEY & CO. LLC AS AGENT
|
|
|
|
By:
|
/s/Christopher Andrews
|
|
Name: Christopher Andrews
|
|
Title: Managing Director
|
|
|
Agreed and Accepted By:
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
By:
|
/s/Dominick Agron
|
|
Name: Dominick Agron
|
|
Title: Vice President & Treasurer
|
______/s/REL_____________
BUYER’S INITIALS
|
_______/s/KC____________
SELLER BMR-LANDMARK AT EASTVIEW LLC’S INITIALS
|
_________/s/KC__________
SELLER BMR-LANDMARK AT EASTVIEW IV LLC’S INITIALS
|
|
Telephone: (858) 485-9840
|
|
E-mail: legalreview@biomedrealty.com
|
|
|
with copy to:
|
c/o The Blackstone Group
|
|
345 Park Avenue, 42nd Floor
|
|
New York, NY 10154
|
|
Attention: Judy Turchin and Giovanni Cutaia
|
|
Telephone: (212) 583-5000
|
|
E-mail: giovanni.cutaia@blackstone.com and
|
|
judy.turchin@blackstone.com
|
|
|
with copy to:
|
Simpson Thacher & Bartlett LLP
|
|
425 Lexington Avenue
|
|
New York, New York 10017
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Attention: Sasan Mehrara, Esq.
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Telephone: (212) 455-2783
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E-mail: smehrara@stblaw.com
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To Buyer:
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Regeneron Pharmaceuticals, Inc.
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777 Old Saw Mill River Road
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|
Tarrytown, New York 10591
|
|
Attention: Joseph J. LaRosa
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Senior Vice President, General Counsel and Secretary
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Telephone: 914-847-7498
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E-mail: Joseph.LaRosa@regeneron.com
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|
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with a copy to:
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Regeneron Pharmaceuticals, Inc.
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|
777 Old Saw Mill River Road
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|
Tarrytown, New York 10591
|
|
Attention: Joanne Deyo
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Vice President, Facilities
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Telephone: (914) 847-7407
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E-mail: Joanne.Deyo@regeneron.com
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|
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with copy to:
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Skadden, Arps, Slate, Meagher & Flom LLP
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|
Four Times Square
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New York, New York 10036
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Attention: Marco Caffuzzi
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Telephone: (212) 735-2661
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E-mail: marco.caffuzzi@skadden.com
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SELLERS:
|
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BMR-LANDMARK AT EASTVIEW LLC,
|
a Delaware limited liability company
|
|
By:
/s/Kenneth A. Caplan
|
Name: Kenneth A. Caplan
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Title: Senior Managing Director and Vice President
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|
BMR-LANDMARK AT EASTVIEW IV LLC,
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a Delaware limited liability company
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|
By:
/s/Kenneth A. Caplan
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Name: Kenneth A. Caplan
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Title: Senior Managing Director and Vice President
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BUYER:
|
|
REGENERON PHARMACEUTICALS, INC.,
|
a New York corporation
|
|
By:
/s/Robert E. Landry
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Name: Robert E. Landry
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Title: SVP - CFO & Finance
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By:
/s/Gregory J. Chaparro
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Name: Gregory J. Chaparro
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Title: SVP
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By:
/s/Gregory J. Chaparro
|
Name: Gregory J. Chaparro
|
Title: SVP
|
By:
/s/Kenneth A. Caplan
|
Name: Kenneth A. Caplan
|
Title: Senior Managing Director and Vice President
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EXHIBITS
|
||
“A”
|
-
|
Legal Description
|
“B”
|
-
|
Reserved
|
“C”
|
-
|
Form of Deed
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“D”
|
-
|
Form of Bill Of Sale, Assignment, and Assumption
|
“E”
|
-
|
Form of Notice to Tenants
|
“F”
|
-
|
Form of Seller Title Certificate
|
“G”
|
-
|
Form of Seller Closing Certificate
|
“H”
|
-
|
Form of Buyer Closing Certificate
|
“I”
|
-
|
Form of FIRPTA
|
“J-1”
|
-
|
Form of Tenant Estoppel
|
“J-2”
|
-
|
Form of Contractor Estoppel
|
Tenant Name
|
Document Type
|
Document Date
|
ACS STATE & LOCAL SOLUTIONS, INC.
|
Amended and Restated Lease
|
12/31/2002
|
|
First Amendment
|
9/26/2003
|
|
Second Amendment
|
2/28/2005
|
|
Third Amendment
|
9/7/2011
|
|
Fourth Amendment
|
10/31/2011
|
Name change: XEROX STATE & LOCAL SOLUTIONS, INC.
(f/k/a ACS State & Local Solutions, Inc.)
|
Fifth Amendment
|
3/15/2016
|
|
|
|
TECHNOVAX, INC.
|
Lease Agreement
|
4/14/2005
|
|
First Amendment
|
5/29/2008
|
|
Second Amendment
|
7/19/2010
|
|
Third Amendment
|
12/24/2010
|
|
Fourth Amendment
|
4/1/2016
|
|
|
|
PSYCHOGENICS INC.
|
Lease Agreement
|
10/21/2011
|
|
First Amendment
|
10/25/2012
|
|
Second Amendment
|
2/1/2013
|
|
|
|
MOMENTIVE PERFORMANCE MATERIALS USA INC.
|
Lease Agreement
|
12/31/2009
|
|
Lease Guaranty
|
12/31/2009
|
|
First Amendment
|
9/17/2010
|
|
Letter Exercising Extension Option
|
12/27/2011
|
|
Second Amendment
|
12/28/2012
|
|
|
|
PEARL RIVER ACQUISITION CORPORATION
|
Space Lease
|
12/23/2008
|
|
Lease Agreement
|
12/23/2008
|
|
Lease Guaranty
|
12/23/2008
|
|
First Amendment to Lease Guaranty
|
5/15/2009
|
|
First Amendment to Lease
|
5/15/2009
|
|
Building Lease
|
5/15/2009
|
|
Amended and Restated Building Lease
|
6/19/2009
|
|
First Amendment to Space Lease
|
6/19/2009
|
|
Lease Termination Agreement
|
6/19/2009
|
|
Amended & Restated Lease Guaranty
|
6/19/2009
|
|
First Amendment
|
5/31/2013
|
|
Term Commencement
|
1/11/2010
|
|
Notice to Terminate Lease
|
5/1/2016
|
METROPOLITAN FIBER SYSTEMS OF NEW YORK
|
Utility Access License Agreement
|
8/1/2003
|
Name change: MCIMETRO ACCESS TRANSMISSION SERVICES, LLC
|
Renewal of License Agreement
|
1/23/2013
|
|
|
|
ICL-IP AMERICA INC.
|
Lease Agreement
|
5/19/2015
|
|
First Amendment
|
5/5/2016
|
|
Acknowledgement of Term Commencement
|
8/10/2016
|
|
Second Amendment
|
8/16/2016
|
|
|
|
COMBE INCORPORATED
|
Lease Agreement
|
3/31/2000
|
|
First Amendment
|
1/7/2003
|
|
Second Amendment
|
4/1/2005
|
|
Third Amendment
|
3/10/2010
|
|
Fourth Amendment
|
8/10/2010
|
|
Fifth Amendment
|
3/4/2011
|
|
Sixth Amendment
|
4/27/2011
|
|
Seventh Amendment
|
11/16/2012
|
|
Eighth Amendment
|
10/31/2014
|
|
Letter Exercising Extension Option
|
3/2/2015
|
|
|
|
EMPIRE MAINTENANCE GROUP
|
Space License Agreement
|
11/1/2015
|
|
|
|
SAVVY NETWORKS, INC.
|
Lease Agreement
|
3/13/2003
|
|
First Amendment
|
12/31/2004
|
|
Second Amendment
|
1/18/2006
|
|
Term Commencement
|
2/17/2006
|
|
Third Amendment
|
10/29/2007
|
Name Change: ANOTHER 9, LLC (successor-in-interest to Savy Networks, Inc.)
|
Fourth Amendment
|
5/18/2010
|
|
Fifth Amendment
|
5/16/2011
|
|
Settlement Agreement
|
3/30/2012
|
|
Sixth Amendment
|
12/21/2012
|
|
|
|
COHERE COMMUNICATIONS (assignee)
|
Assignment & Assumption of Lease
|
9/30/2014
|
|
|
|
ARMGO PHARMA, INC.
|
Lease Agreement
|
12/22/2009
|
|
Term Commencement
|
3/10/2010
|
|
First Amendment
|
3/16/2010
|
|
Work Letter
|
3/23/2010
|
|
|
|
BAYER HEALTHCARE LLC
|
Lease Agreement
|
11/16/2006
|
|
Lease Guaranty
|
11/16/2006
|
|
Term Commencement
|
7/10/2007
|
|
First Amendment
|
11/29/2007
|
ASCENSIA DIABETES CARE US, INC. (assignee)
|
Assignment & Assumption of Lease
|
1/4/2015
|
|
Consent to Assignment of Lease
|
1/4/2016
|
|
|
|
INNOTECH USA, INC.
|
Lease Agreement
|
5/30/2003
|
|
First Amendment
|
12/4/2006
|
Name Change: AEROLASE CORPORATION (f/k/a)
|
Second Amendment
|
9/13/2011
|
|
Third Amendment
|
1/11/2013
|
|
Acknowledgement of Substitute 777 Premises Commencement Date
|
1/17/2013
|
|
Fourth Amendment
|
3/10/2016
|
|
|
|
HOME DEPOT U.S.A., Inc.
|
Ground Lease Agreement
|
9/7/2006
|
•
|
Firewall, located in the basement of 777
|
•
|
Router, located in the basement of 777
|
•
|
CISCO phone system, located in the basement of 777 and BMR management office
|
•
|
Meraki wireless access points, located in the BMR management office
|
•
|
Switches, located in the BMR management office
|
•
|
Computers, located in the BMR management office
|
•
|
Monitors, located in the BMR management office
|
•
|
Xerox copier, located in the BMR management office
|
•
|
Cell phones
|
•
|
Laptops
|
•
|
iPads
|
1.
|
Variations between Tax Map and record description.
|
2.
|
Until a guaranteed survey is received, the title policy will not insure the exact location, courses, distances and dimensions of the premises or the bed of any street, road or avenue passing through the said premises or any state of facts that a survey would show.
|
3.
|
No title is insured to any land now or formerly lying in the bed of SAW MILL RIVER, its arms, branches or tributaries by whatever name called.
|
4.
|
Rights of others to the natural and unobstructed flow of any rivers, brooks and streams crossing premises.
|
5.
|
Subject to riparian rights and easements of others and over SAW MILL RIVER, but policy does not insure any riparian rights or easements in favor of the owner of the premises as described in the title report.
|
6.
|
Truck Sewer Line Easement granted to the COUNTY OF WESTCHESTER for the Saw Mill Sewer Project contained in Liber 3298 cp 166 and located on the Filed Maps No. 3932, 3933 and No. 3934.
|
7.
|
Terms Conditions of the unrecorded Easement Agreements for Air Space over Old Saw Mill River Road between the TOWN OF GREENBURGH and UNION CARBIDE CORP. dated August 21, 1968 with reference to the bridge thereon over Old Saw Mill River Road.
|
8.
|
Agreement and Easement between UNION CARBIDE CORPORATION and the TOWN OF GREENBURGH contained in Liber 7661 cp 320, located as shown on Map 19469.
|
9.
|
Access Easement, 20 feet wide, Reserved in Liber 4045 cp 92 for ingress and egress in favor of the COUNTY OF WESTCHESTER from Old Saw Mill Road to the Potter's Filed, A/K/A County Home Cemetery and referred to in Liber 4087 cp 405.
|
10.
|
Covenants and Restrictions as set forth in Deed recorded in Liber 5203 cp 58 and as shown on Filed Map No. 19473.
|
11.
|
Easements, public and private over so much of the premises described in Schedule A, which lies in the present or former bed of SAW MILL RIVER ROAD and OLD SAW MILL RIVER ROAD, for all street purposes including but not limited to utilities, water and sewer lines, telegraph, telephone and power lines.
|
12.
|
Notes, Easements and Wetlands as shown on Filed Map No. 27669, filed on 11/15/05.
|
13.
|
Notes, Easements and Wetlands as shown on Filed Map #27754.
|
14.
|
Memorandum of Agreement dated 8/19/05 recorded 6/16/06 in Control # 461580136 made by and between Madison Square Garden, L.P. with Eastview Holdings, LLC (and Helicopter Landing Area Restrictions).
|
15.
|
Water Line Easement with the Town of Greenburgh recorded 10/13/06 in Control # 462700118.
|
16.
|
Sewer Line Easement with the Town of Greenburgh recorded 10/13/06 in Control # 462700131.
|
17.
|
Easement Agreement between Eastview Holdings LLC and BMR-LANDMARK AT EASTVIEW, LLC dated 8/4/07 and recorded 10/10/07 in Control No. 472740314 (Stormwater Drainage).
|
18.
|
Reciprocal Easement Agreement between Eastview Holding LLC and BMR-LANDMARK AT EASTVIEW, LLC dated 8/16/07 and recorded 9/5/07 in Control No. 47360279 (Loop Road Easements).
|
19.
|
Easement Agreement between Eastview Holdings LLC and BMR-LANDMARK AT EASTVIEW, LLC and MSG Training Center, LLC, dated 8/16/07 and recorded 9/5/07 in Control No. 472360254 (Right of Way and Road Widening).
|
20.
|
Reciprocal Easement Agreement between Eastview Holdings LLC and BMR-LANDMARK AT EASTVIEW, LLC, and MSG Training Center, LLC dated 8/16/07 and recorded 9/5/07 in Control No. 472360245 (Detention Basin).
|
21.
|
Memorandum of Lease between BMR-LANDMARK AT EASTVIEW, LLC and REGENERON PHARMACEUTICALS, INC. dated 12/12/06 and recorded 2/22/07 in Control No. 470330388.
|
22.
|
Memorandum of Cost Allocation Agreement by and between Eastview Holdings LLC and BMR-LANDMARK AT EASTVIEW LLC dated 12/28/07 and to be recorded as amended by agreements recorded as Control Nos. 490280046 and 500050324.
|
23.
|
Easement among Consolidated Edison, Eastview Holdings LLC and BMR-Landmark at Eastview LLC dated 11/7/07, recorded 6/5/08 as Control No. 481430158 (drainage near softball field).
|
24.
|
Covenants and Restrictions as set forth in Deed recorded in Liber 5203 Cp. 58 and as shown on Filed Map No. 19473.
|
25.
|
Notes, Easements and Wetlands as shown on Filed Map No. 28024.
|
26.
|
Water Line Easement with the Town of Greenburgh recorded 10/13/06 in Control No. 462700118.
|
27.
|
Water Easement Agreement by and between EASTVIEW HOLDINGS LLC and THE TOWN OF MOUNT PLEASANT dated 3/31/06 and recorded 8/2/06 in Control No. 462020467, as amended by Agreement dated 11/12/13 and recorded 11/19/13 as Control No. 533173332 (affects Lot 1 and 2 on Filed Map No. 28024).
|
28.
|
Memorandum of Lease made by and between EASTVIEW HOLDINGS LLC and HOME DEPOT U.S.A., INC. dated 9/7/06 and recorded 11/17/06 in Control No. 462710333.
|
29.
|
Easements and Restrictions Agreement between EASTVIEW HOLDINGS LLC and HOME DEPOT U.S.A, INC. dated 9/7/06 and recorded 11/17/06 in Control No. 462890371.
|
30.
|
Easement Agreement made by and between EASTVIEW HOLDINGS LLC and BMR-LANDMARK AT EASTVIEW, LLC, and HOME DEPOT U.S.A, INC dated 8/31/06 and recorded 11/17/06 in Control No. 462890373.
|
31.
|
Memorandum of Cost Allocation Agreement by and between Eastview Holdings LLC and BMR-Landmark at Eastview LLC dated 12/28/07 and recorded 2/6/09 as Control No. 490280041, as amended in Control No. 490280046 and 500050324.
|
32.
|
Easement Agreement (Re: Parking and Access Road) by and between Eastview Holdings LLC and BMR-Landmark at Eastview LLC dated 12/28/07 and recorded 2/6/09 as Control No. 490280078.
|
33.
|
Trailway Easement among The County of Westchester, Eastview Holdings LLC and BMR-Landmark at Eastview LLC dated 12/5/08, recorded 12/22/08 as Control No. 483460309 and Filed Map No. 28156.
|
34.
|
Rights of Tenant Progenics Pharmaceuticals Inc. under lease dated 10/28/09, a Memorandum of which was recorded 3/29/10 as Control No. 500273310, wherein BMR-Landmark at
|
35.
|
Note for Information Only: A deed dated 12/28/07 made by Eastview Holdings LLC to BMR-Landmark at Eastview LLC was recorded 2/6/09 as Control No. 483310118 (See Exhibit FF). This deed purports to convey a parcel of land and improvements designated as “Lot PAR” on filed map 27754 (See Exhibit GG). Filed Map 27754 does not contain a lot designated as “Lot PAR”, but does show an area labeled “Bldg Over” - “Tax Lot P - AR”, which area is over a public right of way commonly known as Old Saw Mill River Road, Rt. 303, which area may be the subject of an unrecorded agreement dated August 21, 1968 between the Town of Greenburgh and Union Carbide Corp.
|
Tenant
|
Security Deposit
(As of 12/7/2016)
|
Aerolase
|
$[****]
|
ARMGO Pharma, Inc.
|
$[****]
|
Cohere Communications, LLC
|
$[****]
|
Combe Incorporated
|
$[****]
|
ICL
|
$[****]
|
Pearl River Acquisition Corp
|
$[****]
|
Total:
|
$561,442.17
|
Project Description - Powerhouse Phase I
|
Original Budget
|
Savings
|
Final Budget
|
Amounts Paid through 12/31/16
|
Remaining Buyer Costs as of 12/31/2016
|
Amount Of Retainage Held as of 12/31/2016
|
Remaining Costs Outside Of Retainage as of 12/31/2016
|
|
Decentralization
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Chillers
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Cooling Tower
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Total Powerhouse Phase I Project Cost
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
Project Description & Components - Powerhouse Phase II
|
Original Budget
|
Savings
|
Final Budget
|
Amounts Paid through 12/31/16
|
Remaining Buyer Costs as of 12/31/2016
|
Amount Of Retainage Held as of 12/31/2016
|
Remaining Costs Outside Of Retainage as of 12/31/2016
|
|
BMR Builders Risk
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Skanska GMP Contract
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Contingency (no Contract)
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Project Commissioning
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Mt. Pleasant Permit Fees
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Total
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
M/E/Vogel Taylor Engineers, P.C.
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Carlin Simpson & Assoc.
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Eco 3rd
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
A&E Reimburseables (no Contract)
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Cosentini/Tetra Tech
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Omega Laboratories, Inc.
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Total
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
Total Powerhouse Phase II Project Cost
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
Project Description - Roof Repairs
|
Original Budget
|
Savings
|
Final Budget
|
Amounts Paid through 12/31/16
|
Remaining Buyer Costs as of 12/31/2016
|
Amount Of Retainage Held as of 12/31/2016
|
Remaining Costs Outside Of Retainage as of 12/31/2016
|
|
Roof Repairs
1
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
1
[****]
|
||||||||
|
|
|
|
|
|
|
|
|
TOTAL REMAINING COSTS
|
40,954,870
|
(3,767,456)
|
37,187,414
|
(35,479,510)
|
$1,707,904
|
647,934
|
$1,059,970
|
•
|
[****]
|
•
|
[****]
|
•
|
[****]
|
1.
|
Letter Agreement dated November 7, 2006 regarding Proposed Lease between BMR-Landmark at Eastview LLC and Bayer for Office and Laboratory Space at 777 Old Saw Mill River Road, Tarrytown, New York 10591, executed by Equis (Broker) and BioMed Realty, L.P.
|
2.
|
Letter Agreement dated December 23, 2009 regarding Lease between BMR-Landmark at Eastview LLC and Armgo Pharma, Inc. at 777 Old Saw Mill River Road, Tarrytown, New York, executed by FirstService Williams New Jersey, LLC (Broker) and Landmark Owner.
|
3.
|
Letter Agreement dated April 1, 2009 regarding Proposed Third Amendment to Lease between BMR-Landmark at Eastview LLC and Regeneron, for Premises at 777 Old Saw Mill River Road, Tarrytown, New York, executed by Studley and Landmark Owner.
|
4.
|
Letter Agreement dated December 13, 2006 regarding Proposed Lease between BMR-Landmark at Eastview LLC and Regeneron for Premises in Buildings to be Built Near 777 Old Saw Mill River Road, Tarrytown, New York, executed by Studley and Landmark Owner.
|
5.
|
Letter Agreement dated November 17, 2009 regarding Proposed Fourth Amendment to Lease between BMR-Landmark at Eastview LLC and Regeneron, for Premises at 755 Old Saw Mill River Road, Tarrytown, New York, executed by Studley and Landmark Owner.
|
6.
|
Letter Agreement dated July 16, 2010 regarding Amendment between BMR-Landmark at Eastview LLC and Regeneron, for Premises at 765 Old Saw Mill River Road, Tarrytown, New York, executed by Studley and Landmark Owner.
|
7.
|
Letter Agreement dated November 11, 2010 regarding Amendment to Lease between BMR-Landmark at Eastview LLC and Regeneron, at 765 and 777 Old Saw Mill River Road, Tarrytown, New York, executed by Studley and Landmark Owner.
|
8.
|
Letter Agreement dated October 19, 2012 regarding Lease Amendment between BMR-Landmark at Eastview LLC and Regeneron, at 765 and 777 Old Saw Mill River Road, Tarrytown, New York, executed by Studley and Landmark Owner.
|
9.
|
Letter Agreement dated April 1, 2013 regarding Lease and Lease Amendments between BMR-Landmark at Eastview LLC and Regeneron, for Premises Located at the Landmark at Eastview in Tarrytown, New York, executed by Studley and Landmark Owner.
|
10.
|
Letter Agreement dated October 2, 2003 regarding CB Richard Ellis Real Estate Services, Inc. Brokerage Commission Agreement regarding The Landmark at Eastview, 765 Old Saw Mill River Road (Portion) between Eastview Holdings LLC and Progenics
|
11.
|
Letter Agreement regarding Amended & Restated Lease between BMR-Landmark at Eastview and Progenics Pharmaceuticals at 769, 771, and 777 Old Saw Mill River Road, Tarrytown, New York, executed by CB Richard Ellis, Inc. (Broker) and Landmark Owner.
|
12.
|
Letter Agreement dated December 17, 2008 regarding Lease between BMR-Landmark at Eastview LLC and Pearl River Acquisition Corporation at 755 Old Saw Mill River Road, Tarrytown, New York, executed by CB Richard Ellis, Inc. (Broker) and BMR-Landmark at Eastview LLC (“Landmark Owner”).
|
13.
|
Letter Agreement dated May 18, 2009 regarding Lease between BMR-Landmark at Eastview LLC and Momentive Performance Materials, Inc. at 769 Old Saw Mill River Road, Tarrytown, New York, executed by Cushman & Wakefield of Connecticut, Inc. (Broker) and Landmark Owner.
|
14.
|
Letter Agreement dated September 30, 2011 regarding Lease Amendment between BMR-Landmark at Eastview LLC and ACS State and Local Solutions, Inc. at 777 Old Saw Mill River Road, Tarrytown, New York, executed by Jones Lang Lasalle Brokerage, Inc. (Broker) and Landmark Owner.
|
15.
|
Letter Agreement regarding Thirteenth Lease Amendment between BMR-Landmark at Eastview LLC and Regeneron Pharmaceuticals, Inc. (“Regeneron”) for Premises Located at the Landmark at Eastview in Tarrytown, New York, dated as of June 10, 2013, executed by Studley, Inc. (“Studley”) as Broker and Landmark Owner.
|
16.
|
Letter Agreement dated June 26, 2015 regarding Lease Amendment between BMR-Landmark at Eastview LLC and Regeneron, for Premises located at The Landmark at Eastview in Tarrytown, New York, executed by Savills Studley, Inc. and Landmark Owner.
|
17.
|
Letter Agreement dated July 7, 2015 regarding Lease Amendment between BMR-Landmark at Eastview LLC and Regeneron for Premises Located at 767 and 777 Old Saw Mill River Road in Tarrytown, New York executed by Transwestern and Landmark Owner.
|
18.
|
Commission Agreement - Lease dated September 27, 2002 regarding Proposed Lease with ACS - State and Local Solutions, Inc. as tenant executed by Cushman & Wakefield of Connecticut, Inc. (Broker) and Eastview Holdings LLC.
|
[****]
|
[****]
|
|
Master Occupant Id: [****]
[****]
Current
|
Day Due:
Last Payment
|
1 Delq Day:
[****]
|
5
[****]
|
||||
12/31/2016
|
CAM
|
CAM Recoveries
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/31/2016
|
ELE
|
Electric Recoveries
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/31/2016
|
MGT
|
Management Fee
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/31/2016
|
RNT
|
Rent
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/31/2016
|
TAX
|
Tax Recoveries
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/31/2016
|
TIR
|
Tenant Imp Rent
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CAM
|
CAM Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
ELE
|
Electric Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
MGT
|
Management Fee
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
RNT
|
Rent
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
TAX
|
Tax Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
TIR
|
Tenant Imp Rent
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
|
|
[****]
Total:
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|||
|
|
|
|
|
|
|
|
|
|
|
[****]
|
[****]
|
|
Master Occupant Id: [****]
[****]
Current
|
Day Due:
Last Payment
|
1 Delq Day:
[****]
|
2
[****]
|
||||
11/1/2016
|
RNT
|
Rent
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/1/2016
|
CAM
|
CAM Recoveries
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/1/2016
|
ELE
|
Electric Recoveries
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/1/2016
|
HVC
|
HVAC Recoveries
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/1/2016
|
RNT
|
Rent
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
12/1/2016
|
TAX
|
Tax Recoveries
|
CH
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
[****]
|
|
|
|
|
|
|
CAM
|
CAM Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
ELE
|
Electric Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
HVC
|
HVAC Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
RNT
|
Rent
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
TAX
|
Tax Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
|
|
[****]
Total:
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
CAM
|
CAM Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
ELE
|
Electric Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
HVC
|
HVAC Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
MGT
|
Management Fee
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
RNT
|
Rent
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
TAX
|
Tax Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
TIR
|
Tenant Imp Rent
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
|
|
[****]
Total:
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
CAM
|
CAM Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
ELE
|
Electric Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
HVC
|
HVAC Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
MGT
|
Management Fee
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
RNT
|
Rent
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
TAX
|
Tax Recoveries
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
TIR
|
Tenant Imp Rent
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
|
|
|
Grand Total:
|
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
Leasing Costs Under Existing Leases (Committed) - Projected through 12/31/2016
|
||||||||
Tenant
|
Suite(s)
|
SF
|
Leasing Cost Type
|
Current Outstanding Balance
|
Amounts Paid through 12/31/16
|
Remaining Buyer Costs as of 12/31/16
|
Amount Of Retainage Held as of 12/31/2016
|
Remaining Costs Outside Of Retainage as of 12/31/2016
|
[****]
1
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
2
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
3
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
4
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
[****]
|
Total Committed Outstanding Leasing Related Capital
|
|
|
$
[****]
|
[****]
$
[****]
|
$
[****]
|
[****]
|
[****]
|
|
|
|
|
|
|
|
|
|
Contractor
|
Type of Contract
|
Commencement Date
|
Associated Boiler Line Equipment Co.
|
Boiler Maintenance
|
01/01/2017
|
Alert Systems LLC (Security Specialists)
|
Security Cameras and Access Systems
|
11/01/2014
|
|
1
st
Amendment
|
11/01/2015
|
|
2
nd
Amendment
|
11/01/2016
|
American Minutemen Sewer & Drain Service
|
General Sewer and Drain
|
10/20/2016
|
Arbon Equipment Corporation
|
Maintenance Loading Dock Doors
|
11/16/2015
|
Asbestos Corporation of America
|
Emergency Abatement
|
02/01/2016
|
Assured Environments (RAMAC Corp)
|
Pest Control
|
02/01/2016
|
Blondie's Treehouse, Inc.
|
Greenwall Maintenance
|
02/01/2016
|
Carrier Corporation
|
Power House Chiller Maintenance
|
09/01/2015
|
Chris Bisceglia (CRB Inc.)
|
Carpentry and Miscellaneous Repairs
|
05/01/2016
|
CoolerSmart USA, LLC
|
Water Cooler Service
|
09/01/2016
|
Empire Maintenance Group Corp.
|
Landscaping Services
|
10/15/2015
|
Empire Maintenance Group Corp.
|
Snow Removal
|
10/01/2015
|
GCS Service Inc.
|
kitchen equipment maintenance program
|
07/01/2016
|
Geese Relief LLC
|
Goose Control
|
01/01/2017
|
Gym Source Northeast Ltd.
|
Fitness Equipment Maintenance
|
11/01/2016
|
Johnson Controls, Inc.
|
Air-Cooled Refrigeration
|
01/15/2016
|
Johnson Controls, Inc.
|
PM on BAS System
|
04/01/2016
|
Lascon, Inc.
|
Annual Roof Inspection
|
10/15/2015
|
Lascon, Inc.
|
General Repairs
|
10/01/2016
|
Liberty Elevator
|
Elevator Maintenance
|
01/01/2017
|
NALCO Company
|
Water Treatment
|
09/01/2015
|
Open Systems Metro NY, Inc.
|
Fire Alarm System Monitoring
|
10/08/2014
|
|
First Amendment
|
10/8/2015
|
Parker Interior Plantscape,
|
Interior Plant Maintenance
|
08/01/2014
|
Inc.
|
|
|
Red Hawk Fire & Security LLC
|
Fire Alarm Systems Testing & Repair
|
12/01/2015
|
Richmar Controls
|
Andover Controls System R&M
|
05/01/2016
|
Safeguard Environmental Service Co.
|
Kitchen Maintenance
|
08/01/2016
|
Safeguard Lock & Key Co. Inc.
|
Locksmith
|
03/01/2014
|
|
1
st
Amendment
|
03/01/2015
|
|
2
nd
Amendment
|
03/01/2016
|
Sani-Pro Disposal Services Corp.
|
Trash Removal
|
05/01/2016
|
Service Bus Company, Inc.
|
Shuttle Service
|
09/01/2016
|
SourceOne, Inc.
|
Network Maintenance Services
|
09/01/2015
|
Tri-State Facade Services, Inc.
|
Window Cleaning
|
04/01/2016
|
United Security, Inc.
|
Security Services
|
01/01/2015
|
SMG Services, LLC
|
Light Bulb Porter
|
9/1/2015
|
|
1
st
Amendment
|
9/1/2016
|
|
Termination Letter
|
12/15/2016
|
SourceOne, Inc.
|
Professional Consulting Services Agreement
|
12/1/2016
|
Homeyer Consulting Services, Inc.
|
Service Contract
|
5/1/2014
|
DirectTV
|
Commercial Customer Agreement
|
6/24/2014
|
Contractor
|
Type of Contract
|
Commencement Date
|
Gardiner & Theobald, Inc.
|
Professional Consulting Services
|
7/1/2014
|
|
1
st
Amendment
|
9/2/2014
|
|
Professional Consulting Services
|
9/22/2014
|
JMC Planning Engineering Landscape Architecture & Land Surveying PLLC
|
Professional Consulting Services
|
7/1/2015
|
Johnson Controls, Inc.
|
Powerhouse House Power Metering
|
7/28/2016
|
|
Roof Repair Project
|
11/2/2016
|
Liberty Elevator
|
Purchase Order - Life Jackets
|
11/9/2016
|
M-E/Vogel Taylor Engineers, P.C.
|
Professional Design Services
|
7/2014
|
|
Professional Design Services
|
10/29/2015
|
|
Professional Consulting Services
|
3/1/2016
|
|
Professional Design Services
|
4/10/2013
|
|
Professional Design Services
|
3/22/2013
|
|
First Amendment
|
2/21/2014
|
|
Second Amendment
|
7/2/2014
|
|
Change Order No.1
|
2/11/2015
|
Perkins+Will, Inc.
|
Professional Design Services
|
5/29/2015
|
|
Change Order No. 1
|
11/21/2016
|
|
Professional Design Services
|
6/26/2015
|
|
Change Order No.1 - Revised
|
9/2/2015
|
|
Change Order No. 2
|
12/2/2015
|
|
Change Order No. 3
|
2/22/2016
|
Sullivan Engineering LLC
|
Professional Design Services
|
3/31/2016
|
|
Change Order No. 1
|
11/14/2016
|
|
Professional Design Services
|
9/9/2016
|
|
Professional Design Services
|
9/9/2016
|
|
Professional Design Services
|
9/9/2016
|
C&W Facility Services, Inc.
|
Purchase Order - Office Furniture
|
8/1/2016
|
Carey & Walsh, Inc.
|
Purchase Order - HVAC Ductwork
|
9/29/2015
|
Carey & Walsh, Inc.
|
Purchase Order - HVAC Ductwork
|
9/4/2015
|
CRB, Inc.
|
Purchase Order - Concrete Repair
|
11/29/2016
|
Dynamic Systems
|
Purchase Order - Piping Refeed
|
7/29/2015
|
Healy Electric Contracting, Inc.
|
Purchase Order - Fire Alarm System Repair
|
12/2/2015
|
ICO Energy and Engineering, Inc.
|
Purchase Order - Commissioning Services
|
5/20/2016
|
Lascon, Inc.
|
Purchase Order - C-level Water Remediation
|
12/1/2016
|
Carlin Simpson & Associates
|
Professional Consulting Services Agreement
|
5/29/2015
|
ComNet Communications LLC
|
Purchase Order - Lifesized Model
|
6/15/2016
|
ComNet Communications LLC
|
Purchase Order - Television/Data Services
|
3/31/2016
|
ComNet Communications
|
Purchase Order - Rewiring
|
6/27/2016
|
Lascon, Inc.
|
Purchase Order - Window Removal
|
9/22/2015
|
M. Arthur Gensler Jr. & Associates, Inc.
|
Professional Design Services Agreement
|
8/28/2015
|
|
Change Order No. 1
|
1/7/2016
|
|
Change Order No. 2
|
3/10/2016
|
|
Change Order No. 3
|
5/3/2016
|
Omega Environmental Services, Inc.
|
ACM Air Monitoring
|
11/13/2015
|
WSP USA Corp.
|
Professional Consulting Services Agreement
|
9/17/2014
|
Maspeth Contracting Corp. dba Maspeth Roofing & Siding, Inc.
|
Construction Contract
(765 Building)
|
10/26/2016
|
Maspeth Contracting Corp. dba Maspeth Roofing & Siding, Inc.
|
Construction Contract
(777 Building)
|
10/26/2016
|
Pavarini North East Construction Co., Inc.
|
Construction Contract
|
2/12/2016
|
|
Change Order No. 1
|
2/22/2016
|
|
Change Order No. 2
|
3/7/2016
|
|
Change Order No. 3
|
6/23/2016
|
|
Change Order No. 4
|
9/26/2016
|
Pavarini North East Construction Co., Inc.
|
Construction Agreement
|
2/17/2016
|
|
Change Order No. 1
|
2/25/2016
|
|
GMP Amendment to Construction Agreement
|
3/4/2016
|
|
Change Order No. 2
|
10/25/2016
|
Pavarini North East Construction Co., Inc.
|
Construction Contract
|
2/23/2016
|
|
Change Order No. 1
|
10/5/2016
|
Unity Mechanical Corp.
|
Construction Contract
|
10/1/2014
|
|
Change Order No. 1
|
5/13/2015
|
|
Change Order No. 2
|
7/8/2016
|
II.
|
Those certain Contracts set forth on Schedule 7.1.4-II herein are incorporated by reference.
|
I.
|
Assumed Non-CapEx Contracts
|
A.
|
Energy Contracts
|
Contractor
|
Type of Service
|
Commencement/
Effective Date
|
Constellation Energy Resources
|
Electricity
|
Master Agreement: 9/17/2014
|
|
|
TC: 1/4/2017
|
Plymouth Rock Energy
|
Natural Gas
|
1/1/2017
|
B.
|
Service Contracts
|
Contractor
|
Type of Service
|
Commencement
Date
|
C&W Facility Services Inc.
|
Engineering Service
|
4/1/2016
|
|
|
|
FLIK International Corporation
|
Food Services
|
7/1/2016
Effective Date: 4/1/2016
|
|
|
|
Healy Electric Contracting, Inc.
|
Electrical Repairs
|
5/1/2016
|
|
Parking Lot Lighting
|
4/1/2016
|
|
|
|
Rotundo Plumbing Corp.
|
Plumping Repairs
|
11/1/2015
|
|
1
st
Amendment
|
11/1/2016
|
|
|
|
SMG Services, LLC
|
Janitorial Services
|
1/1/2017
|
|
Linen Service
|
3/1/2014
|
|
1
st
Amendment
|
3/31/2015 (Execution Date)
|
|
2
nd
Amendment
|
3/31/2016 (Execution Date)
|
C.
|
Brokerage Agreements
|
D.
|
Telecommunications Contracts
|
II.
|
Uncompleted Capex Contracts
|
Contractor
|
Type of Contract
|
Commencement/Effective Date (as applicable)
|
Cosentini Associates, Inc. (Tetra Tech)
|
Purchase Order - Code Consulting Services
|
4/14/2016
|
M-E/Vogel Taylor Engineers, P.C.
|
Professional Design Services
|
6/9/2014
|
|
|
|
Skanska USA Building, Inc.
|
Construction Contract
|
11/2/2015
|
|
Change Order No. 1
|
2/11/2016
|
|
Change Order No. 2
|
6/22/2016
|
|
Change Order No. 3
|
8/11/2016
|
|
Change Order No. 4
|
9/29/2016
|
|
GMP Amendment
|
5/24/2016
|
|
|
|
Omega Environmental Services, Inc.
|
Perform Air Monitoring during ACM Activity
|
1/21/2016
|
•
|
Notice of Transfer of service from Verizon to Pacific Telemanagement Services, Invoice ID No. 77707713, effective November 15, 2011.
|
•
|
Service Contract made and executed as of October 1, 2015, by and between BMR-Landmark at Eastview LLC and Kings III America, Inc., d/b/a Kings III Emergency Communications.
|
•
|
Service Contract made and executed as of January 15, 2016, by and between BMR-Landmark at Eastview LLC and Kings III America, Inc., d/b/a Kings III Emergency Communications.
|
•
|
Service Agreement dated January 23, 2013, between BMR-Landmark at Eastview LLC and Spring Solutions, Inc.
|
•
|
Channel Service Agreement Order Form between The Landmark at Eastview and Avaya, executed April 6, 2007 and acknowledged June 11, 2007.
|
|
[BMR‑LANDMARK AT EASTVIEW LLC/ BMR-LANDMARK AT EASTVIEW IV LLC],
a Delaware limited liability company
By:
|
||
|
|
Name:
|
|
|
|
Title:
|
|
STATE OF NEW YORK
|
)
|
|
) ss:
|
COUNTY OF NEW YORK
|
)
|
Notary Public |
|
DATED: As of
|
|
, 2017
|
|
|
|
|
|
SELLER
|
|
|
|
[BMR-LANDMARK AT EASTVIEW LLC/BMR-LANDMARK AT EASTVIEW IV LLC]
|
|||
a Delaware limited liability company
|
|||
By:
|
|
|
|
Name:
|
|
|
|
Title:
|
|
|
|
|
|
|
|
BUYER:
|
|
|
|
[REGENERON PHARMACEUTICALS, INC.
|
|||
a New York corporation]
|
|||
By:
|
|
|
|
Name:
|
|
|
|
Title:
|
|
|
|
Re:
|
Landmark at Eastview, Mt. Pleasant and Greenburgh, New York
|
|
|
|
|
|
With a copy to:
|
|
|
|
|
By:
|
|
Name:
|
|
Title:
|
|
Owner:
|
|
|
|
|
|
[BMR-LANDMARK AT EASTVIEW LLC],
|
||
a Delaware limited liability company
|
||
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
SELLERS:
|
|
|
|
|
|
[BMR-LANDMARK AT EASTVIEW LLC],
|
||
a Delaware limited liability company
|
||
|
|
|
By:
|
|
|
Name:
|
|
|
Its:
|
|
|
|
|
|
|
|
|
BUYER:
|
|
By:
|
Name:
|
Title:
|
By:
|
|
|
|
|
Name:
|
|
|
Title:
|
Re:
|
Landmark at Eastview
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
Date:
|
|
, 2016
|
«Lease__License_Agreement»
|
«Lease_Date»
|
«Document_1»
|
«Document_1_Date»
|
«Document_2»
|
«Document_2_Date»
|
«Document_3»
|
«Document_3_Date»
|
«Document_4»
|
«Document_4_Date»
|
Re:
|
Landmark at Eastview
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
Date:
|
|
, 2016
|
Summary of Contract Terms
|
|
(1)
|
Name of Contractor
|
(2)
|
Contract Date
|
(3)
|
Amendment Dates, Executed Change Orders, if any:
|
(5)
|
Contract Commencement Date:
|
|
Current Contract Expiration:
|
(6)
|
Amount Paid Under Contract:
|
(7)
|
Amount Owed Under Contract:
|
(8)
|
Retainage Amounts:
|
(9)
|
Remaining Work To Be Completed:
|
|
Name of Subsidiary*
|
|
State or Other Jurisdiction of Incorporation or Organization
|
|
Loop Road Holdings LLC
|
|
New York
|
|
Old Saw Mill Holdings LLC
|
|
New York
|
|
OSMR Holdings
|
|
Bermuda
|
|
OSMR International
|
|
Bermuda
|
|
Regeneron Assurance, Inc.
|
|
New York
|
|
Regeneron Belgium BVBA
|
|
Belgium
|
|
Regeneron Capital International B.V.
|
|
The Netherlands
|
|
Regeneron Genetics Center LLC
|
|
Delaware
|
|
Regeneron Healthcare Solutions, Inc.
|
|
New York
|
|
Regeneron International Holdings LLC
|
|
Delaware
|
|
Regeneron International Unlimited Company
|
|
Ireland
|
|
Regeneron Ireland Holdings Unlimited Company
|
|
Ireland
|
|
Regeneron Ireland Unlimited Company
|
|
Ireland
|
|
Regeneron Spain, S.L.U.
|
|
Spain
|
|
Regeneron UK Limited
|
|
United Kingdom
|
|
Rockwood Road Holdings LLC
|
|
New York
|
|
_____________
|
|
|
|
* Directly or indirectly wholly owned by Regeneron Pharmaceuticals, Inc.
|
||
|
|
|
|
1.
|
I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
|
2.
|
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;
|
3.
|
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;
|
4.
|
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:
|
a)
|
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;
|
b)
|
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;
|
c)
|
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
|
d)
|
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
|
5.
|
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):
|
a)
|
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
|
b)
|
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.
|
Date:
|
February 9, 2017
|
/s/ Leonard S. Schleifer
|
|
|
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
President and Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
1.
|
I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
|
2.
|
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;
|
3.
|
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;
|
4.
|
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:
|
a)
|
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;
|
b)
|
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;
|
c)
|
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
|
d)
|
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
|
5.
|
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):
|
a)
|
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
|
b)
|
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.
|
Date:
|
February 9, 2017
|
/s/ Robert E. Landry
|
|
|
|
Robert E. Landry
|
|
|
|
Senior Vice President, Finance and Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Leonard S. Schleifer
|
Leonard S. Schleifer, M.D., Ph.D.
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
February 9, 2017
|
|
/s/ Robert E. Landry
|
Robert E. Landry
|
Senior Vice President, Finance and Chief Financial Officer
|
(Principal Financial Officer)
|
February 9, 2017
|