FORM 10-K
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(Mark One)
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ý
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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, 2017
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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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ý
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No
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¨
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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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¨
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No
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ý
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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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No
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¨
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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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No
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¨
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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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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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¨
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(Do not check if a smaller reporting company)
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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¨
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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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¨
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No
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The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was approximately $50,337,000,000, computed by reference to the closing sales price of the stock on NASDAQ on June 30, 2017, 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, 2018:
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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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1,911,354
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Common Stock, $.001 par value
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105,785,444
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DOCUMENTS INCORPORATED BY REFERENCE
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Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its 2018 Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages 88 to 95 of this filing.
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Page Numbers
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"ARCALYST
®
", "EYLEA
®
", "ZALTRAP
®
", "
VelocImmune
®
", "
VelociGene
®
", "
VelociMouse
®
", "
VelociMab
®
", "
VelociSuite
®
", and "Regeneron Genetics Center
®"
are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners.
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•
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EYLEA (aflibercept) Injection, which is approved by the U.S. Food and Drug Administration (FDA), European Union (EU), Japan, and certain other countries for use in retinal indications, delivered net sales growth of
11.4%
over 2016 in the United States and net sales growth of
18.9%
outside the United States. In December 2017, the supplemental Biologics License Application (sBLA) for a 12-week dosing interval of EYLEA in patients with neovascular age-related macular degeneration (wet AMD) was filed with the FDA, with a target action date of August 11, 2018. A Phase 3 study for the treatment of non-proliferative diabetic retinopathy (NPDR) in patients without diabetic macular edema (DME) completed enrollment.
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•
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Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis received regulatory approval in the United States and EU. We also reported positive results from two additional pivotal Phase 3 studies of dupilumab for the treatment of asthma, and recently submitted an sBLA with the FDA. We reported positive results in the Phase 2 study in eosinophilic esophagitis (EoE). Phase 3 studies in patients (12-17 years of age and 6-11 years of age) with atopic dermatitis and pediatric patients (6-11 years of age) with asthma were initiated.
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The Phase 3 cardiovascular outcomes study of Praluent has recently been completed, and a Phase 3 study for the treatment of homozygous familial hypercholesterolemia (HoFH) was initiated. The U.S. Court of Appeals for the Federal Circuit ordered a new trial on the issues of written description and enablement and vacated the permanent injunction in the ongoing PCSK9 litigation. The sBLA for use of Praluent with apheresis was filed with the FDA, with a target action date of August 24, 2018.
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Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) received regulatory approval in the United States, EU, and Japan.
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We reported positive top-line results from a pivotal Phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC). We have commenced a rolling BLA submission to the FDA and expect to complete the submission in the first quarter of 2018. The FDA granted Breakthrough Therapy designation to cemiplimab for the treatment of adults with metastatic CSCC and adults with locally advanced and unresectable CSCC. A Phase 3 study as a first-line treatment for non-small cell lung cancer (NSCLC) and a Phase 3 study in cervical cancer were initiated. A potentially pivotal Phase 2 study in basal cell carcinoma (BCC) was also initiated.
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Phase 3 efficacy studies of fasinumab in osteoarthritis of the knee or hip were initiated, while the Phase 3 long-term safety study in osteoarthritis continued patient enrollment. A Phase 3 study in chronic low back pain in patients with concomitant osteoarthritis of the knee and hip was also initiated.
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The FDA granted Breakthrough Therapy designation for evinacumab for the treatment of hypercholesterolemia in patients with HoFH.
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We advanced one new product candidate (REGN3918, an antibody to complement 5 (C5)) into Phase 1 clinical development.
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We entered into significant new research and development license and collaboration arrangements, including agreements with the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) to develop new treatments to combat infectious diseases; Decibel Therapeutics, Inc. to discover and develop new potential therapeutics to protect, repair, and restore hearing; and ISA Pharmaceuticals B.V. to develop ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab.
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•
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From a growth perspective, we hired our 6,000
th
employee, completed a new lease financing for our laboratory and office facilities in Tarrytown, New York, continued to expand our bulk drug product manufacturing operations in Rensselaer, New York, and continued build-out and validation activities at our 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 five of the past seven years, with second-place rankings in 2015 and 2011.
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•
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EYLEA (aflibercept) Injection
, known in the scientific literature as VEGF Trap-Eye, is available in the United States, EU, Japan, and certain other countries outside the United States for the treatment of wet AMD, 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.
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Dupixent
(dupilumab) Injection.
On March 28, 2017, the FDA approved Dupixent for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The launch of Dupixent commenced in March following the FDA approval. In September 2017, the European Commission granted marketing authorization for Dupixent for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in January 2018, the Ministry of Health, Labor and Welfare (MHLW) in Japan approved Dupixent for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies.
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Praluent (alirocumab) Injection
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 (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of high low-density lipoprotein (LDL) cholesterol. Praluent is also available in certain European countries and in Japan. In April 2017, the FDA approved the sBLA for a once-monthly (every four weeks), 300 mg dose of Praluent. In July 2017, the FDA approved the sBLA for Praluent's time out of refrigeration, which was increased from 24 hours to 30 days. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
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•
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Kevzara
(sarilumab) Solution for Subcutaneous Injection
. In January 2017, Health Canada approved Kevzara 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 was the first approval of Kevzara worldwide. On May 22, 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response or intolerance to one or more DMARDs. In June 2017, the European Commission granted marketing authorization for Kevzara in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; Kevzara may be used as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. In September 2017, the MHLW in Japan approved Kevzara for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional treatments.
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•
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ARCALYST
®
(rilonacept) Injection for Subcutaneous Use
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. CAPS are a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.
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•
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ZALTRAP
®
(ziv-aflibercept) Injection for Intravenous Infusion
, known in the scientific literature as VEGF Trap, 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, 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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Net Product Sales of Regeneron-Discovered Products
(1)
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Year Ended December 31,
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(In millions)
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2017
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2016
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2015
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EYLEA in the United States
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$
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3,701.9
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$
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3,323.1
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$
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2,676.0
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ARCALYST
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16.5
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15.3
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13.5
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Net product sales recorded by Regeneron
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$
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3,718.4
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$
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3,338.4
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$
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2,689.5
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EYLEA outside of the United States
(1)
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$
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2,226.9
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$
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1,872.3
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$
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1,413.3
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EYLEA global
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$
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5,928.8
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$
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5,195.4
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$
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4,089.3
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Global net product sales recorded by Sanofi
(1)
:
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Praluent in the United States
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$
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131.4
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$
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94.4
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$
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9.5
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Praluent outside of the United States
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63.3
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21.9
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1.0
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Praluent global
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194.7
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116.3
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10.5
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Dupixent
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256.5
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—
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—
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Kevzara
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13.3
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—
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—
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ZALTRAP
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83.8
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72.3
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85.7
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Net product sales recorded by Sanofi
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$
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548.3
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$
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188.6
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$
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96.2
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(1)
As described in the "General" section above, Bayer records net product sales of EYLEA outside the United States and Sanofi records global net product sales of Praluent, Dupixent, Kevzara, and ZALTRAP.
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Phase 1
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Phase 2
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Phase 3
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Cemiplimab (REGN2810)
(a)
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Dupilumab
(a)
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EYLEA
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Antibody to programmed cell death protein 1 (PD-1)
(h)
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Antibody to the interleukin-4 receptor (IL-4R) alpha subunit
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NPDR in patients without DME
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Solid tumors and advanced hematologic malignancies
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EoE
(c)
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Dupilumab
(a)
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REGN3767
(a)
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Sarilumab
(a)
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Atopic dermatitis in adolescents and pediatrics (6–17 years of age)
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Antibody to Lymphocyte Activation Gene 3 (LAG-3) protein
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Antibody to the interleukin-6 receptor (IL-6R)
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Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)
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Advanced malignancies (administered alone or in combination with cemiplimab)
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Polyarticular-course juvenile idiopathic arthritis (pcJIA)
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Asthma in adults and adolescents
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Asthma in pediatrics (6–11 years of age)
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REGN1979
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Cemiplimab
(a)
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Nasal polyps
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Bispecific antibody against CD20 and CD3
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Metastatic or locally advanced and unresectable CSCC (pivotal study)
(d)
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Praluent
(a)
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Certain B-cell malignancies (monotherapy and in combination cemiplimab)
(c)
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BCC (potentially pivotal study)
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Antibody to PCSK9
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Evinacumab (REGN1500)
(f)
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LDL cholesterol reduction and prevention of cardiovascular events
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REGN3470-3471-3479
(g)
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Antibody to angiopoietin-like protein 3 (ANGPTL3)
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HoFH
(c)
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Multi-antibody therapy to Ebola virus
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HoFH
(c)(d)
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Cemiplimab
(a)
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Ebola virus infection
(c)
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Refractory hypercholesterolemia (both HeFH and non-FH)
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First-line treatment for NSCLC
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REGN1908-1909
(f)
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Cervical cancer
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Multi-antibody therapy to Feld1
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Fasinumab (REGN475)
(b)(f)
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Allergic disease
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Osteoarthritis of knee and hip
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REGN3500
(a)
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Chronic low back pain in patients with concomitant osteoarthritis of the knee and hip
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Antibody to interleukin-33 (IL-33). Studied as monotherapy and in combination with dupilumab.
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Evinacumab (REGN1500)
(f)
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Asthma
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HoFH
(c)(d)
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Trevogrumab (REGN1033)
(f)
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Antibody to myostatin (GDF8)
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Muscle wasting diseases (in combination with REGN2477)
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REGN2477
(f)
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Antibody to Activin A
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Fibrodysplasia ossificans progressiva (FOP)
(c)(e)
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Muscle-wasting diseases (in combination with trevogrumab)
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REGN3918
(f)
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Antibody to complement 5 (C5)
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Paroxysmal nocturnal hemoglobinuria (PNH)
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(a)
In collaboration with Sanofi
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(b)
In collaboration with Teva and Mitsubishi Tanabe Pharma
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(c)
FDA granted orphan drug designation
|
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(d)
FDA granted Breakthrough Therapy designation
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(e)
FDA granted Fast Track designation
|
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(f)
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 global sales of the product candidate.
|
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(g)
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. We and BARDA of the HHS are parties to agreements (including an agreement executed in September 2017 - see "Other Programs" below for further information) whereby HHS provides certain funding to support research, development, and manufacturing of an antibody therapy for the treatment of Ebola virus infection.
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(h)
Studied as monotherapy and in combination with other antibodies and treatments
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•
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The mean change in the Eosinophilic Esophagitis Endoscopic Reference Score (EoE-EREFS) at 12 weeks was significantly reduced by 1.9 points from baseline (48% improvement) in patients who received dupilumab compared to 0.3 points (7% improvement) for those who received placebo (p=0.0006). EoE-EREFS is a visual measure of disease severity (inflammation and fibrosis in the esophagus) on a 0–8 point scale, with 8 indicating more severe disease. The mean baseline score was 3.9 for dupilumab and 4.3 for placebo.
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•
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The mean percent change in overall peak intraepithelial eosinophil count from baseline to 12 weeks was significantly reduced by 93% in patients who received dupilumab compared to an increase of 14% in those who received placebo (p<0.0001).
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•
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The mean percent change in a composite measure of symptoms and quality of life, as measured by Eosinophilic Esophagitis Symptom Activity Index (EEsAI), was numerically improved at 10 weeks (although not statistically significant) by 35% in patients who received dupilumab compared to an 11% improvement for those who received placebo (p=0.085).
|
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 AG and Genentech/Roche
|
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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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Genentech/Roche
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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, PLC
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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, Inc.
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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 (two non-inferiority Phase 3 trials comparing RTH258 and EYLEA met their primary endpoint in June 2017)
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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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RG7716, a bi-specific antibody targeting anti-VEGF and Ang2
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In development (Phase 2)
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Genentech/Roche
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Wet AMD, DME
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—
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Lucentis
port delivery system
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In development (Phase 2)
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Genentech/Roche
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Wet AMD and related conditions
|
|
—
|
X-82, an orally administered small molecule tyrosine kinase inhibitor in development for use in combination with EYLEA or Lucentis
|
|
In development (Phase 2)
|
|
Tyrogenex
|
|
Wet AMD and related conditions
|
|
—
|
DE-122, an anti-endoglin antibody in development for use in combination with EYLEA or Lucentis
|
|
In development (Phase 2)
|
|
Santen Pharmaceuticals Co. Ltd./ TRACON Pharmaceuticals, Inc.
|
|
Wet AMD and related conditions
|
|
—
|
GB-102, an intravitreally administered depot formulation of the small molecule tyrosine kinase inhibitor, sunitinib
|
|
In development (Phase 2)
|
|
Graybug Vision, Inc.
|
|
Wet AMD and related conditions
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EYLEA (continued):
|
||||||||
Competitor
Product/Product Candidate |
|
Commercial or
Development Status |
|
Competitor
|
|
Indication
|
|
Territory
|
OPT-302, a VEGFR-3 large molecule trap in development for use in combination with EYLEA or Lucentis
|
|
In development (Phase 2b)
|
|
Opthea Limited
|
|
Wet AMD and related conditions
|
|
—
|
M710, a biosimilar to EYLEA
|
|
In development (Phase 3)
|
|
Momenta Pharmaceuticals, Inc. (in partnership with Mylan N.V.)
|
|
Wet AMD and related conditions
|
|
—
|
CHS-3351, a biosimilar to Lucentis
|
|
In development (Phase 1)
|
|
Coherus BioSciences, Inc.
|
|
Wet AMD and related conditions
|
|
—
|
PF582, a biosimilar to Lucentis
|
|
In development (Phase 1/2 completed in August 2016)
|
|
Pfenex Inc.
|
|
Wet AMD and related conditions
|
|
—
|
FYB201, a biosimilar to Lucentis
|
|
In development (Phase 3)
|
|
Formycon AG (in collaboration with Bioeq GmbH)
|
|
Wet AMD and related conditions
|
|
—
|
SB11, a biosimilar to Lucentis
|
|
In development (Phase 3)
|
|
Samsung Bioepis Co., Ltd.
|
|
Wet AMD and related conditions
|
|
—
|
Razumab, a biosimilar to Lucentis
|
|
Approved in India for wet AMD and related conditions
|
|
Intas Phamaceuticals Limited
|
|
Wet AMD and related conditions
|
|
India
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
|
Indication
|
|
Territory
|
Eucrisa
®
(crisaborole)
|
|
Approved
|
|
Pfizer
|
|
Mild-to-moderate atopic dermatitis
|
|
United States
|
Xolair
®
(omalizumab)
|
|
Approved
|
|
Roche/Novartis
|
|
Asthma
|
|
Worldwide
|
Nucala
®
(mepolizumab)
|
|
Approved for asthma
In development (Phase 2) for atopic dermatitis
|
|
GlaxoSmithKline (GSK)
|
|
Asthma and atopic dermatitis
|
|
Worldwide
|
Cinqair
®
(reslizumab)
|
|
Approved
|
|
Teva
|
|
Asthma
|
|
Worldwide
|
Fasenra
®
(benralizumab)
|
|
Approved
|
|
AstraZeneca
|
|
Asthma
|
|
United States, EU
|
Tralokinumab, an anti-IL-13 antibody
|
|
In development (Phase 3)
|
|
AstraZeneca/ LEO Pharma Inc.
|
|
Atopic dermatitis
|
|
—
|
Baricitinib, an orally administered JAK inhibitor
|
|
In development (Phase 3)
|
|
Eli Lilly and Company/Incyte Corporation
|
|
Atopic dermatitis
|
|
—
|
PF-04965842, an orally administered JAK inhibitor
|
|
In development (Phase 3)
|
|
Pfizer
|
|
Atopic dermatitis
|
|
—
|
Upadacitinib, an orally administered JAK inhibitor
|
|
In development (Phase 3)
|
|
AbbVie
|
|
Atopic dermatitis
|
|
—
|
Fevipiprant, an orally administered CRTH2 antagonist
|
|
In development (Phase 3)
|
|
Novartis
|
|
Asthma
|
|
—
|
Tezepelumab, an anti-TSLP antibody
|
|
In development (Phase 3)
|
|
Amgen Inc./AstraZeneca
|
|
Asthma
|
|
—
|
ANB-020, an anti-IL-33 antibody
|
|
In development (Phase 2)
|
|
AnaptysBio, Inc.
|
|
Asthma and atopic dermatitis
|
|
—
|
Lebrikizumab, an anti-IL-13 antibody
|
|
In development (Phase 2)
|
|
Dermira, Inc./Roche
|
|
Atopic dermatitis
|
|
—
|
Nemolizumab, an anti-IL-31R antibody
|
|
In development (Phase 2)
|
|
Galderma S.A.
|
|
Atopic dermatitis
|
|
—
|
CNTO7610, an anti-ST2 antibody
|
|
In development (Phase 2 for asthma and Phase 1 for atopic dermatitis)
|
|
Johnson & Johnson
|
|
Asthma and atopic dermatitis
|
|
—
|
RG6149, an anti-ST2 antibody
|
|
In development (Phase 2)
|
|
Roche
|
|
Asthma
|
|
—
|
MEDI-9314, an anti-IL-4R antibody
|
|
In development (Phase 1)
|
|
AstraZeneca
|
|
Atopic dermatitis
|
|
—
|
PRS-060, an inhaled anticalin targeting IL-4R
|
|
In development (Phase 1)
|
|
AstraZeneca/ Pieris Pharmaceuticals, Inc.
|
|
Asthma
|
|
—
|
Competitor Product/Product Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
|
Indication
|
|
Territory
|
Repatha
®
(evolocumab)
|
|
Approved
|
|
Amgen
|
|
(1) Reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease, (2) primary hyperlipidemia, and (3) HoFH
|
|
Worldwide
|
Inclisiran (ALN-PCSsc)
|
|
In development (Phase 2)
|
|
Alnylam Pharmaceuticals (in collaboration with The Medicines Company)
|
|
RNAi molecule against PCSK9 (injectable, small molecule)
|
|
—
|
ETC-1002 (bempedoic acid)
|
|
In development (Phase 3)
|
|
Esperion Therapeutics, Inc.
|
|
ACL-inhibitor
(oral, small molecule)
|
|
—
|
Gemcabene
|
|
In development (Phase 2)
|
|
Gemphire Therapeutics Inc.
|
|
Cholesterol synthesis inhibitor (oral, small molecule)
|
|
—
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
|
Indication
|
|
Territory
|
Actemra
®
(tocilizumab)
|
|
Approved
|
|
Roche
|
|
Rheumatoid arthritis
|
|
Worldwide
|
Orencia
®
(abatacept)
|
|
Approved
|
|
Bristol-Myers Squibb Company
|
|
Rheumatoid arthritis
|
|
Worldwide
|
Xeljanz
®
(tofacitinib)
|
|
Approved
|
|
Pfizer
|
|
Rheumatoid arthritis
|
|
Worldwide
|
Olumiant
®
(baricitinib)
|
|
Approved
|
|
Eli Lilly/Incyte
|
|
Rheumatoid arthritis
|
|
EU
|
Olokizumab, an anti-IL-6 antibody
|
|
In development (Phase 3)
|
|
R-Pharm
|
|
Rheumatoid arthritis
|
|
—
|
Upadacitinib, an orally administered JAK inhibitor
|
|
In development (Phase 3)
|
|
AbbVie
|
|
Rheumatoid arthritis
|
|
—
|
Filgotinib, an orally administered JAK inhibitor
|
|
In development (Phase 3)
|
|
Gilead Sciences, Inc./
Galapagos NV
|
|
Rheumatoid arthritis
|
|
—
|
Peficitinib, an orally administered JAK inhibitor
|
|
In development (Phase 3)
|
|
Astellas Pharma Inc.
|
|
Rheumatoid arthritis
|
|
—
|
Clazakizumab, an anti-IL-6 antibody
|
|
In development (Phase 2)
|
|
Vitaeris Inc.
|
|
Rheumatoid arthritis
|
|
—
|
Vobarilizumab, an anti-IL-6R antibody fragment
|
|
In development (Phase 2)
|
|
Ablynx NV
|
|
Rheumatoid arthritis
|
|
—
|
Gerilimzumab, an anti-IL-6 antibody
|
|
In development (Phase 1)
|
|
Bird Rock Bio, Inc.
|
|
Rheumatoid arthritis
|
|
—
|
Regeneron Antibody
Program
|
|
Competitor
|
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Target
|
Cemiplimab (Phase 2/3)
Target: PD-1
|
|
Bristol-Myers Squibb
|
|
Opdivo
®
(nivolumab)
|
|
Approved
|
|
Antibody against PD-1
|
|
|
Merck & Co., Inc.
|
|
Keytruda
®
(pembrolizumab)
|
|
Approved
|
|
Antibody against PD-1
|
|
|
Pfizer/
Merck
|
|
Bavencio
®
(avelumab)
|
|
Approved
|
|
Antibody against PDL-1
|
|
|
Roche
|
|
Tecentriq
®
(atezolizumab)
|
|
Approved
|
|
Antibody against PDL-1
|
|
|
AstraZeneca
|
|
Imfinzi
®
(durvalumab)
|
|
Approved
|
|
Antibody against PDL-1
|
|
|
Novartis
|
|
PDR001
|
|
In development (Phase 3)
|
|
Antibody against PD-1
|
|
|
Celgene Corporation/
BeiGene Ltd.
|
|
BGB-A317
|
|
In development (Phase 3)
|
|
Antibody against PD-1
|
|
|
Agenus Inc.
|
|
AGEN2034
|
|
In development (Phase 1)
|
|
Antibody against PD-1
|
|
|
TESARO, Inc./AnaptysBio
|
|
TSR-042
|
|
In development (Phase 1)
|
|
Antibody against PD-1
|
|
|
Pfizer
|
|
PFE-06801591
|
|
In development (Phase 1)
|
|
Antibody against PD-1
(Subcutaneous Formulation)
|
Fasinumab (Phase 3)
Target: NGF
|
|
Pfizer/Eli Lilly
|
|
Tanezumab
|
|
In development (Phase 3)
|
|
Antibody against NGF
|
Evinacumab (Phase 3)
Target: ANGPTL3
|
|
Ionis Pharmaceuticals, Inc./Akcea Therapeutics, Inc.
|
|
AKCEA-ANGPTL3-LRx
|
|
In development (Phase 2)
|
|
Ligand conjugated antisense drug against ANGPTL3
|
•
|
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;
|
•
|
sufficient coverage of, and reimbursement for, EYLEA by 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 results of post-approval studies of EYLEA (whether conducted by us or by others and whether mandated by regulatory agencies or voluntary), and studies of other products that could implicate VEGF inhibitors as a class or are perceived to do so;
|
•
|
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 these products, 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 these products from competitive products (including, in the case of Dupixent, Pfizer's Xeljanz and Eli Lilly's Olumiant; in the case of Praluent, Amgen's Repatha; and, in the case of Kevzara, Genentech/Roche's Actemra), as well as product candidates currently in clinical development (such as, in the case of Dupixent, the antibody product candidates being developed by Roche, LEO Pharma, AstraZeneca, Galderma, AnaptysBio, and Amgen);
|
•
|
the outcome of the pending patent infringement proceedings relating to Dupixent (described further in Note 17 to our Consolidated Financial Statements), and other risks relating to Dupixent 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 outcome of the pending patent infringement proceedings relating to Praluent initiated by Amgen against us and Sanofi (described further in Note 17 to our Consolidated Financial Statements), and other risks relating to Praluent 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;
|
•
|
sufficient coverage of, and reimbursement for, these products by 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;
|
•
|
the results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary (including, in the case of Praluent, the ODYSSEY OUTCOMES trial prospectively assessing the potential of Praluent to demonstrate cardiovascular benefit), and studies of other products that could implicate an entire class of products or are perceived to do so;
|
•
|
our ability to meet the demand for commercial supplies of these products;
|
•
|
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 these products with parties who perform fill/finish or other steps in the manufacture of these products 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.
|
•
|
net product sales of our marketed products, in particular EYLEA and Dupixent, as well as our overall operating results;
|
•
|
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 the market share for, our marketed products, especially EYLEA and Dupixent;
|
•
|
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 EPO and in the USPTO;
|
•
|
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
10.4%
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, 2017, and
21.5%
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, 2017; and
|
•
|
our five largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately
47.2%
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, 2017. In addition, these five shareholders plus our Chief Executive Officer held approximately
53.0%
of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of December 31, 2017.
|
•
|
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
|
||||
2017
|
|
|
|
|
||||
First Quarter
|
|
$
|
401.21
|
|
|
$
|
340.09
|
|
Second Quarter
|
|
543.55
|
|
|
360.00
|
|
||
Third Quarter
|
|
526.12
|
|
|
426.47
|
|
||
Fourth Quarter
|
|
477.00
|
|
|
353.14
|
|
||
|
|
|
|
|
||||
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
|
|
|
12/31/2012
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
|
12/31/2017
|
||||||||||||
Regeneron
|
$
|
100.00
|
|
|
$
|
160.89
|
|
|
$
|
239.81
|
|
|
$
|
317.34
|
|
|
$
|
214.58
|
|
|
$
|
219.77
|
|
S&P 500
|
$
|
100.00
|
|
|
$
|
129.60
|
|
|
$
|
144.36
|
|
|
$
|
143.31
|
|
|
$
|
156.98
|
|
|
$
|
187.47
|
|
NQ US Pharma TR Index
|
$
|
100.00
|
|
|
$
|
135.68
|
|
|
$
|
165.28
|
|
|
$
|
174.27
|
|
|
$
|
172.37
|
|
|
$
|
207.54
|
|
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
|
|||||
10/1/2017-10/31/2017
|
|
184
|
|
|
$
|
440.50
|
|
|
—
|
|
|
—
|
|
11/1/2017-11/30/2017
|
|
515
|
|
|
$
|
405.27
|
|
|
—
|
|
|
—
|
|
12/1/2017-12/31/2017
|
|
257,850
|
|
|
$
|
386.90
|
|
|
—
|
|
|
—
|
|
Total
|
|
258,549
|
|
|
$
|
386.97
|
|
|
—
|
|
|
—
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||
(In thousands, except per share data)
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
|
$
|
3,718,463
|
|
|
$
|
3,338,390
|
|
|
$
|
2,689,478
|
|
|
$
|
1,750,762
|
|
|
$
|
1,425,839
|
|
Sanofi and Bayer collaboration revenue
|
|
1,815,245
|
|
|
1,402,935
|
|
|
1,339,361
|
|
|
1,036,854
|
|
|
650,400
|
|
|||||
Other revenue
|
|
338,519
|
|
|
119,102
|
|
|
74,889
|
|
|
31,941
|
|
|
28,506
|
|
|||||
|
|
5,872,227
|
|
|
4,860,427
|
|
|
4,103,728
|
|
|
2,819,557
|
|
|
2,104,745
|
|
|||||
Expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
2,075,142
|
|
|
2,052,295
|
|
|
1,620,577
|
|
|
1,271,353
|
|
|
859,947
|
|
|||||
Selling, general, and administrative
|
|
1,320,433
|
|
|
1,177,697
|
|
|
838,526
|
|
|
519,267
|
|
|
346,393
|
|
|||||
Cost of goods sold
|
|
202,507
|
|
|
194,624
|
|
|
241,702
|
|
|
129,030
|
|
|
118,048
|
|
|||||
Cost of collaboration and contract manufacturing
|
|
194,554
|
|
|
105,070
|
|
|
151,007
|
|
|
75,988
|
|
|
37,307
|
|
|||||
|
|
3,792,636
|
|
|
3,529,686
|
|
|
2,851,812
|
|
|
1,995,638
|
|
|
1,361,695
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income from operations
|
|
2,079,591
|
|
|
1,330,741
|
|
|
1,251,916
|
|
|
823,919
|
|
|
743,050
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Other income (expense), net
|
|
(1,080
|
)
|
|
(926
|
)
|
|
(26,819
|
)
|
|
(62,684
|
)
|
|
(46,668
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income before income taxes
|
|
2,078,511
|
|
|
1,329,815
|
|
|
1,225,097
|
|
|
761,235
|
|
|
696,382
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income tax expense
(1)
|
|
(880,000
|
)
|
|
(434,293
|
)
|
|
(589,041
|
)
|
|
(423,109
|
)
|
|
(282,644
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income
|
|
$
|
1,198,511
|
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
|
$
|
338,126
|
|
|
$
|
413,738
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income per share - basic
|
|
$
|
11.27
|
|
|
$
|
8.55
|
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
|
$
|
4.23
|
|
Net income per share - diluted
|
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
$
|
3.72
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
As of December 31,
|
||||||||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents, and marketable securities (current and non-current)
|
|
$
|
2,896,074
|
|
|
$
|
1,902,944
|
|
|
$
|
1,677,385
|
|
|
$
|
1,360,634
|
|
|
$
|
1,083,875
|
|
Total assets
|
|
8,764,286
|
|
|
6,973,466
|
|
|
5,609,132
|
|
|
3,837,672
|
|
|
2,950,130
|
|
|||||
Convertible senior notes (current and non-current)
|
|
—
|
|
|
—
|
|
|
10,802
|
|
|
146,773
|
|
|
320,315
|
|
|||||
Capital and facility lease obligations (current and non-current)
|
|
703,453
|
|
|
481,126
|
|
|
364,708
|
|
|
312,291
|
|
|
185,323
|
|
|||||
Stockholders' equity
|
|
6,144,078
|
|
|
4,449,245
|
|
|
3,654,837
|
|
|
2,550,251
|
|
|
1,964,716
|
|
ITEM 7.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
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, 2014
|
$
|
3.1
|
|
|
$
|
21.2
|
|
|
$
|
0.5
|
|
|
$
|
24.8
|
|
Provisions
|
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
|
|
||||
Provisions
|
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
|
|
||||
Provisions
|
167.8
|
|
|
194.1
|
|
|
46.4
|
|
|
408.3
|
|
||||
Credits/payments
|
(150.6
|
)
|
|
(189.5
|
)
|
|
(28.7
|
)
|
|
(368.8
|
)
|
||||
Balance as of December 31, 2017
|
$
|
29.9
|
|
|
$
|
34.1
|
|
|
$
|
21.3
|
|
|
$
|
85.3
|
|
Net Income
|
Year Ended December 31,
|
||||||||||
(In millions)
|
2017
|
|
2016
|
|
2015
|
||||||
Revenues
|
$
|
5,872.2
|
|
|
$
|
4,860.4
|
|
|
$
|
4,103.7
|
|
Operating expenses
|
(3,792.6
|
)
|
|
(3,529.7
|
)
|
|
(2,851.8
|
)
|
|||
Other income (expense), net
|
(1.1
|
)
|
|
(0.9
|
)
|
|
(26.8
|
)
|
|||
Income before income taxes
|
2,078.5
|
|
|
1,329.8
|
|
|
1,225.1
|
|
|||
Income tax expense
|
(880.0
|
)
|
|
(434.3
|
)
|
|
(589.0
|
)
|
|||
Net income
|
$
|
1,198.5
|
|
|
$
|
895.5
|
|
|
$
|
636.1
|
|
|
|
|
|
|
|
||||||
Net income per share - diluted
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
Revenues
|
Year Ended December 31,
|
||||||||||
(In millions)
|
2017
|
|
2016
|
|
2015
|
||||||
Net product sales in the United States:
|
|
|
|
|
|
||||||
EYLEA
|
$
|
3,701.9
|
|
|
$
|
3,323.1
|
|
|
$
|
2,676.0
|
|
ARCALYST
|
16.5
|
|
|
15.3
|
|
|
13.5
|
|
|||
Sanofi and Bayer collaboration revenue:
|
|
|
|
|
|
||||||
Sanofi
|
877.2
|
|
|
658.7
|
|
|
758.9
|
|
|||
Bayer
|
938.1
|
|
|
744.3
|
|
|
580.5
|
|
|||
Other revenue
|
338.5
|
|
|
119.0
|
|
|
74.8
|
|
|||
Total revenues
|
$
|
5,872.2
|
|
|
$
|
4,860.4
|
|
|
$
|
4,103.7
|
|
Sanofi Collaboration Revenue
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses - Discovery Agreement
|
|
$
|
130.0
|
|
|
$
|
130.0
|
|
|
$
|
145.0
|
|
Reimbursement of Regeneron research and development expenses - License and Collaboration Agreement
|
|
378.4
|
|
|
434.9
|
|
|
590.4
|
|
|||
Reimbursement of Regeneron commercialization-related expenses
|
|
368.8
|
|
|
305.9
|
|
|
155.3
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(442.6
|
)
|
|
(459.0
|
)
|
|
(240.0
|
)
|
|||
Other
|
|
119.1
|
|
|
28.4
|
|
|
12.3
|
|
|||
Total Antibody
|
|
553.7
|
|
|
440.2
|
|
|
663.0
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses - Discovery Agreement
|
|
138.8
|
|
|
86.5
|
|
|
29.2
|
|
|||
Reimbursement of Regeneron research and development expenses - License and Collaboration Agreement
|
|
101.2
|
|
|
52.0
|
|
|
10.8
|
|
|||
Other
|
|
83.5
|
|
|
80.0
|
|
|
40.0
|
|
|||
Total Immuno-oncology
|
|
323.5
|
|
|
218.5
|
|
|
80.0
|
|
|||
ZALTRAP:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
—
|
|
|
—
|
|
|
0.7
|
|
|||
Other
|
|
—
|
|
|
—
|
|
|
15.2
|
|
|||
Total ZALTRAP
|
|
—
|
|
|
—
|
|
|
15.9
|
|
|||
Total Sanofi collaboration revenue
|
|
$
|
877.2
|
|
|
$
|
658.7
|
|
|
$
|
758.9
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
||||||
Praluent in the United States
|
|
$
|
131.4
|
|
|
$
|
94.4
|
|
|
$
|
9.5
|
|
Praluent outside of the United States
|
|
63.3
|
|
|
21.9
|
|
|
1.0
|
|
|||
Praluent global
|
|
194.7
|
|
|
116.3
|
|
|
10.5
|
|
|||
Dupixent
|
|
256.5
|
|
|
—
|
|
|
—
|
|
|||
Kevzara
|
|
13.3
|
|
|
—
|
|
|
—
|
|
Bayer Collaboration Revenue
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
||||||
EYLEA:
|
|
|
|
|
|
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
802.3
|
|
|
$
|
649.2
|
|
|
$
|
466.7
|
|
Sales milestones
|
|
—
|
|
|
—
|
|
|
15.0
|
|
|||
Reimbursement of Regeneron EYLEA development expenses
|
|
13.3
|
|
|
9.0
|
|
|
8.9
|
|
|||
Other
|
|
58.7
|
|
|
52.6
|
|
|
69.4
|
|
|||
Total EYLEA
|
|
874.3
|
|
|
710.8
|
|
|
560.0
|
|
|||
Ang2 antibody and PDGFR-beta antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of development expenses
|
|
17.8
|
|
|
18.3
|
|
|
10.1
|
|
|||
Other
|
|
46.0
|
|
|
15.2
|
|
|
10.4
|
|
|||
Total Ang2 antibody and PDGFR-beta antibody
|
|
63.8
|
|
|
33.5
|
|
|
20.5
|
|
|||
Total Bayer collaboration revenue
|
|
$
|
938.1
|
|
|
$
|
744.3
|
|
|
$
|
580.5
|
|
Regeneron's Net Profit from EYLEA Sales Outside the United States
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
||||||
Net product sales outside the United States
|
|
$
|
2,226.9
|
|
|
$
|
1,872.3
|
|
|
$
|
1,413.3
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
856.1
|
|
|
703.3
|
|
|
521.8
|
|
|||
Reimbursement of EYLEA development expenses incurred by Bayer in accordance with Regeneron's payment obligation
|
|
(53.8
|
)
|
|
(54.1
|
)
|
|
(55.1
|
)
|
|||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
802.3
|
|
|
$
|
649.2
|
|
|
$
|
466.7
|
|
Other Revenue
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
||||||
Teva collaboration revenue:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
115.1
|
|
|
$
|
24.2
|
|
|
—
|
|
|
Substantive development milestones
|
|
60.0
|
|
|
—
|
|
|
—
|
|
|||
Other
|
|
46.4
|
|
|
13.7
|
|
|
—
|
|
|||
Total Teva collaboration revenue
|
|
221.5
|
|
|
37.9
|
|
|
—
|
|
|||
Other revenue
|
|
117.0
|
|
|
81.2
|
|
|
$
|
74.9
|
|
||
Total other revenue
|
|
$
|
338.5
|
|
|
$
|
119.1
|
|
|
$
|
74.9
|
|
•
|
Under the terms of the Amended ZALTRAP Agreement, Sanofi's reimbursement for manufacturing commercial supplies of ZALTRAP and a percentage of aggregate net sales of ZALTRAP.
|
•
|
Recognition of revenue related to amortization of the $165.0 million up-front payment we received in August 2010, which was deferred upon receipt and is being recognized as revenue through mid-2018, in connection with the
VelocImmune
license agreement with Astellas. In addition, Astellas will make a $130.0 million second payment to us in June 2018 unless the license agreement has been terminated prior to that date. Astellas has the right to terminate the agreement at any time by providing 90 days' advance written notice.
|
•
|
Royalties in connection with a June 2009 agreement with Novartis, under which we receive royalties on worldwide sales of Novartis' Ilaris
®
(canakinumab). The royalty rates in the agreement start at 4% and reach 15% when annual sales exceed $1.5 billion, and we are entitled to royalties until Novartis ceases sale of products subject to royalty.
|
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
|
2017 vs. 2016
|
|
2016 vs. 2015
|
||||||||||
Research and development
|
|
$
|
2,075.1
|
|
|
$
|
2,052.3
|
|
|
$
|
1,620.6
|
|
|
$
|
22.8
|
|
|
$
|
431.7
|
|
Selling, general, and administrative
|
|
1,320.4
|
|
|
1,177.7
|
|
|
838.5
|
|
|
142.7
|
|
|
339.2
|
|
|||||
Cost of goods sold
|
|
202.5
|
|
|
194.6
|
|
|
241.7
|
|
|
7.9
|
|
|
(47.1
|
)
|
|||||
Cost of collaboration and contract manufacturing
|
|
194.6
|
|
|
105.1
|
|
|
151.0
|
|
|
89.5
|
|
|
(45.9
|
)
|
|||||
Total operating expenses
|
|
$
|
3,792.6
|
|
|
$
|
3,529.7
|
|
|
$
|
2,851.8
|
|
|
$
|
262.9
|
|
|
$
|
677.9
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Average headcount
|
|
5,780
|
|
|
4,927
|
|
|
3,713
|
|
|
853
|
|
|
1,214
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
||||||
Income tax expense
|
|
$
|
880.0
|
|
|
$
|
434.3
|
|
|
$
|
589.0
|
|
Effective tax rate
|
|
42.3
|
%
|
|
32.7
|
%
|
|
48.1
|
%
|
|
As of December 31,
|
|
Increase
|
||||||||
(In millions)
|
2017
|
|
2016
|
|
(Decrease)
|
||||||
Financial assets:
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
812.7
|
|
|
$
|
535.2
|
|
|
$
|
277.5
|
|
Marketable securities - current
|
596.8
|
|
|
503.5
|
|
|
93.3
|
|
|||
Marketable securities - non-current
|
1,486.5
|
|
|
864.2
|
|
|
622.3
|
|
|||
|
$
|
2,896.0
|
|
|
$
|
1,902.9
|
|
|
$
|
993.1
|
|
|
|
|
|
|
|
||||||
Working capital:
|
|
|
|
|
|
||||||
Current assets
|
$
|
4,335.0
|
|
|
$
|
3,180.2
|
|
|
$
|
1,154.8
|
|
Current liabilities
|
1,135.5
|
|
|
1,241.5
|
|
|
(106.0
|
)
|
|||
|
$
|
3,199.5
|
|
|
$
|
1,938.7
|
|
|
$
|
1,260.8
|
|
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||||||||||
(In millions)
|
|
2017
|
|
2016
|
|
2015
|
|
2017 vs. 2016
|
|
2016 vs. 2015
|
||||||||||
Cash flows provided by operating activities
|
|
$
|
1,307.1
|
|
|
$
|
1,473.4
|
|
|
$
|
1,330.8
|
|
|
$
|
(166.3
|
)
|
|
$
|
142.6
|
|
Cash flows used in investing activities
|
|
(1,005.2
|
)
|
|
(1,046.9
|
)
|
|
(907.6
|
)
|
|
41.7
|
|
|
$
|
(139.3
|
)
|
||||
Cash flows used in financing activities
|
|
(24.4
|
)
|
|
(700.4
|
)
|
|
(262.8
|
)
|
|
676.0
|
|
|
$
|
(437.6
|
)
|
|
|
|
|
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)
|
|
$
|
1,404.3
|
|
|
$
|
816.9
|
|
|
$
|
485.9
|
|
|
$
|
62.8
|
|
|
$
|
38.7
|
|
Capital and facility lease obligations
(2)
|
|
105.7
|
|
|
21.1
|
|
|
50.1
|
|
|
34.5
|
|
|
—
|
|
|||||
Operating leases
|
|
21.9
|
|
|
9.0
|
|
|
7.0
|
|
|
4.4
|
|
|
1.5
|
|
|||||
Total contractual obligations
|
|
$
|
1,531.9
|
|
|
$
|
847.0
|
|
|
$
|
543.0
|
|
|
$
|
101.7
|
|
|
$
|
40.2
|
|
(1)
|
Purchase and other obligations primarily relate to research and development commitments, including those related to clinical trials, and capital expenditures. Our obligation to pay certain of these amounts may increase or be reduced based on relevant future events.
|
(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 the purchase price we would be obligated to pay if we were to exercise our option to purchase the Facility.
|
(In millions)
|
|
Notional Amount
|
||
Interest rate swap contracts
|
|
$
|
75.0
|
|
Interest rate cap contracts
|
|
$
|
75.0
|
|
10.1 +
|
|
10.1.1 +
|
|
10.1.2 +
|
|
10.1.3 +
|
|
10.1.5 +
|
|
10.1.6 +
|
|
10.1.7 +
|
|
10.1.8 +
|
|
10.1.9 +
|
|
10.1.10 +
|
|
10.2 +
|
|
10.2.1 +
|
|
10.2.2 +
|
|
10.2.3 +
|
|
10.2.4 +
|
10.9*
|
|
10.10*
|
|
10.10.1*
|
|
10.11
|
|
10.12
|
|
10.12.1*
|
|
10.12.2
|
|
10.12.3
|
|
10.12.4
|
|
10.12.5
|
|
10.12.6
|
|
10.12.7
|
|
10.12.8
|
|
10.12.9
|
|
10.12.10
|
|
10.12.11
|
|
10.12.12
|
|
10.12.13
|
|
10.12.14
|
|
10.12.15
|
10.12.16
|
|
10.12.17
|
|
10.13
|
|
10.13.1
|
|
10.14*
|
|
10.14.1*
|
|
10.15*
|
|
10.15.1*
|
|
10.16*
|
|
10.16.1*
|
|
10.16.2*
|
|
10.17
|
|
10.18
|
|
10.19
|
|
10.20
|
|
10.20.1
|
|
10.20.2
|
10.20.3
|
|
10.20.4
|
|
10.21
|
|
10.22
|
|
10.22.1
|
|
10.22.2
|
|
10.22.3
|
|
10.22.4
|
|
10.23
|
|
10.24
|
|
10.24.1
|
|
10.24.2
|
|
10.24.3
|
|
10.24.4
|
|
10.24.5
|
|
10.25
|
|
10.26
|
10.26.1
|
|
10.26.2
|
|
10.26.3
|
|
10.27*
|
|
10.27.1*
|
|
10.27.2*
|
|
10.27.3
|
|
10.28*
|
|
10.29
|
|
10.29.1
|
|
10.30*
|
|
10.31*
|
|
10.32*
|
|
10.33*
|
|
10.34*
|
10.35*
|
|
10.36
|
|
10.37
|
|
10.38
|
|
21.1
|
|
23.1
|
|
24.1
|
|
31.1
|
|
31.2
|
|
32
|
|
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 8, 2018
|
|
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 8, 2018
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
/s/ ROBERT E. LANDRY
|
|
Senior Vice President, Finance and Chief Financial Officer (Principal Financial Officer)
|
|
February 8, 2018
|
Robert E. Landry
|
|
|
|
|
/s/ CHRISTOPHER R. FENIMORE
|
|
Vice President, Controller (Principal Accounting Officer)
|
|
February 8, 2018
|
Christopher R. Fenimore
|
|
|
|
|
/s/ GEORGE D. YANCOPOULOS
|
|
President, Chief Scientific Officer, and Director
|
|
February 8, 2018
|
George D. Yancopoulos, M.D., Ph.D.
|
|
|
|
|
/s/ P. ROY VAGELOS
|
|
Chairman of the Board
|
|
February 8, 2018
|
P. Roy Vagelos, M.D.
|
|
|
|
|
/s/ CHARLES A. BAKER
|
|
Director
|
|
February 8, 2018
|
Charles A. Baker
|
|
|
|
|
/s/ BONNIE L. BASSLER
|
|
Director
|
|
February 8, 2018
|
Bonnie L. Bassler, Ph.D.
|
|
|
|
|
/s/ MICHAEL S. BROWN
|
|
Director
|
|
February 8, 2018
|
Michael S. Brown, M.D.
|
|
|
|
|
/s/ N. ANTHONY COLES
|
|
Director
|
|
February 8, 2018
|
N. Anthony Coles, M.D.
|
|
|
|
|
/s/ JOSEPH L. GOLDSTEIN
|
|
Director
|
|
February 8, 2018
|
Joseph L. Goldstein, M.D.
|
|
|
|
|
/s/ CHRISTINE A. POON
|
|
Director
|
|
February 8, 2018
|
Christine A. Poon
|
|
|
|
|
/s/ ARTHUR F. RYAN
|
|
Director
|
|
February 8, 2018
|
Arthur F. Ryan
|
|
|
|
|
/s/ GEORGE L. SING
|
|
Director
|
|
February 8, 2018
|
George L. Sing
|
|
|
|
|
/s/ MARC TESSIER-LAVIGNE
|
|
Director
|
|
February 8, 2018
|
Marc Tessier-Lavigne, Ph.D.
|
|
|
|
|
/s/ HUDA Y. ZOGHBI
|
|
Director
|
|
February 8, 2018
|
Huda Y. Zoghbi, M.D.
|
|
|
|
|
|
|
Page Numbers
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
812,733
|
|
|
$
|
535,203
|
|
Marketable securities
|
596,847
|
|
|
503,481
|
|
||
Accounts receivable - trade, net
|
1,538,642
|
|
|
1,343,368
|
|
||
Accounts receivable from Sanofi
|
193,684
|
|
|
92,989
|
|
||
Accounts receivable from Bayer
|
242,014
|
|
|
175,263
|
|
||
Inventories
|
726,138
|
|
|
399,356
|
|
||
Prepaid expenses and other current assets
|
224,972
|
|
|
130,528
|
|
||
Total current assets
|
4,335,030
|
|
|
3,180,188
|
|
||
|
|
|
|
||||
Marketable securities
|
1,486,494
|
|
|
864,260
|
|
||
Property, plant, and equipment, net
|
2,358,605
|
|
|
2,083,421
|
|
||
Deferred tax assets
|
506,291
|
|
|
825,303
|
|
||
Other assets
|
77,866
|
|
|
20,294
|
|
||
Total assets
|
$
|
8,764,286
|
|
|
$
|
6,973,466
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
815,078
|
|
|
$
|
879,096
|
|
Capital and facility lease obligations
|
—
|
|
|
129,557
|
|
||
Deferred revenue from Sanofi, current portion
|
177,746
|
|
|
115,267
|
|
||
Deferred revenue - other, current portion
|
142,392
|
|
|
116,397
|
|
||
Other current liabilities
|
267
|
|
|
1,178
|
|
||
Total current liabilities
|
1,135,483
|
|
|
1,241,495
|
|
||
|
|
|
|
||||
Capital and facility lease obligations
|
703,453
|
|
|
351,569
|
|
||
Deferred revenue from Sanofi
|
379,936
|
|
|
503,474
|
|
||
Deferred revenue - other
|
249,263
|
|
|
327,298
|
|
||
Other long-term liabilities
|
152,073
|
|
|
100,385
|
|
||
Total liabilities
|
2,620,208
|
|
|
2,524,221
|
|
||
|
|
|
|
||||
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 - 1,911,354 in 2017 and 1,911,456 in 2016
|
2
|
|
|
2
|
|
||
Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - 109,477,222 in 2017 and 107,860,567 in 2016
|
110
|
|
|
108
|
|
||
Additional paid-in capital
|
3,512,833
|
|
|
3,029,993
|
|
||
Retained earnings
|
2,946,733
|
|
|
1,748,222
|
|
||
Accumulated other comprehensive income (loss)
|
640
|
|
|
(12,840
|
)
|
||
Treasury Stock, at cost; 3,763,868 shares in 2017 and 2016
|
(316,240
|
)
|
|
(316,240
|
)
|
||
Total stockholders' equity
|
6,144,078
|
|
|
4,449,245
|
|
||
Total liabilities and stockholders' equity
|
$
|
8,764,286
|
|
|
$
|
6,973,466
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Statements of Operations
|
|
|
|
|
|
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Net product sales
|
|
$
|
3,718,463
|
|
|
$
|
3,338,390
|
|
|
$
|
2,689,478
|
|
Sanofi collaboration revenue
|
|
877,193
|
|
|
658,665
|
|
|
758,873
|
|
|||
Bayer collaboration revenue
|
|
938,052
|
|
|
744,270
|
|
|
580,488
|
|
|||
Other revenue
|
|
338,519
|
|
|
119,102
|
|
|
74,889
|
|
|||
|
|
5,872,227
|
|
|
4,860,427
|
|
|
4,103,728
|
|
|||
|
|
|
|
|
|
|
||||||
Expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
2,075,142
|
|
|
2,052,295
|
|
|
1,620,577
|
|
|||
Selling, general, and administrative
|
|
1,320,433
|
|
|
1,177,697
|
|
|
838,526
|
|
|||
Cost of goods sold
|
|
202,507
|
|
|
194,624
|
|
|
241,702
|
|
|||
Cost of collaboration and contract manufacturing
|
|
194,554
|
|
|
105,070
|
|
|
151,007
|
|
|||
|
|
3,792,636
|
|
|
3,529,686
|
|
|
2,851,812
|
|
|||
|
|
|
|
|
|
|
||||||
Income from operations
|
|
2,079,591
|
|
|
1,330,741
|
|
|
1,251,916
|
|
|||
|
|
|
|
|
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
||||||
Other income (expense), net
|
|
24,039
|
|
|
6,269
|
|
|
(12,578
|
)
|
|||
Interest expense
|
|
(25,119
|
)
|
|
(7,195
|
)
|
|
(14,241
|
)
|
|||
|
|
(1,080
|
)
|
|
(926
|
)
|
|
(26,819
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income before income taxes
|
|
2,078,511
|
|
|
1,329,815
|
|
|
1,225,097
|
|
|||
|
|
|
|
|
|
|
||||||
Income tax expense
|
|
(880,000
|
)
|
|
(434,293
|
)
|
|
(589,041
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
1,198,511
|
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
11.27
|
|
|
$
|
8.55
|
|
|
$
|
6.17
|
|
Net income per share - diluted
|
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
|
106,338
|
|
|
104,719
|
|
|
103,061
|
|
|||
Weighted average shares outstanding - diluted
|
|
115,954
|
|
|
116,367
|
|
|
115,230
|
|
|||
|
|
|
|
|
|
|
||||||
Statements of Comprehensive Income
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
1,198,511
|
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
||||||
Unrealized gain (loss) on marketable securities
|
|
12,715
|
|
|
(21,412
|
)
|
|
(43,679
|
)
|
|||
Unrealized gain on cash flow hedges
|
|
765
|
|
|
—
|
|
|
—
|
|
|||
Comprehensive income
|
|
$
|
1,211,991
|
|
|
$
|
874,110
|
|
|
$
|
592,377
|
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Class A Stock
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Retained Earnings
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Treasury Stock
|
|
Total Stockholders' Equity
|
|||||||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
Shares
|
|
Amount
|
|
|||||||||||||||||||||
Balance, December 31, 2014
|
|
1,973
|
|
|
$
|
2
|
|
|
102,475
|
|
|
$
|
102
|
|
|
$
|
2,450,782
|
|
|
$
|
216,644
|
|
|
$
|
52,251
|
|
|
(2,018
|
)
|
|
$
|
(169,530
|
)
|
|
$
|
2,550,251
|
|
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
2,457
|
|
|
2
|
|
|
215,460
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
215,462
|
|
|||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(298
|
)
|
|
—
|
|
|
(160,538
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(160,538
|
)
|
|||||||
Issuance of Common Stock in connection with conversion of convertible notes
|
|
—
|
|
|
—
|
|
|
1,625
|
|
|
2
|
|
|
818,358
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
818,360
|
|
|||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan
|
|
—
|
|
|
—
|
|
|
31
|
|
|
—
|
|
|
15,382
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15,382
|
|
|||||||
Issuance of restricted stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
28
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Class A Stock converted 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 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
|
|
|
8,572
|
|
|
(3,643
|
)
|
|
(306,069
|
)
|
|
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 notes
|
|
—
|
|
|
—
|
|
|
121
|
|
|
—
|
|
|
48,004
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
48,004
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
1,198,511
|
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
145,467
|
|
|
104,745
|
|
|
74,909
|
|
|||
Non-cash compensation expense
|
|
507,277
|
|
|
559,878
|
|
|
459,049
|
|
|||
Other non-cash charges and expenses, net
|
|
63,581
|
|
|
45,139
|
|
|
52,562
|
|
|||
Deferred taxes
|
|
318,809
|
|
|
(360,078
|
)
|
|
(121,623
|
)
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Increase in Sanofi, Bayer, and trade accounts receivable
|
|
(362,720
|
)
|
|
(143,827
|
)
|
|
(491,421
|
)
|
|||
Increase in inventories
|
|
(314,195
|
)
|
|
(149,776
|
)
|
|
(111,825
|
)
|
|||
(Increase) decrease in prepaid expenses and other assets
|
|
(113,331
|
)
|
|
23,543
|
|
|
(79,476
|
)
|
|||
(Decrease) increase in deferred revenue
|
|
(113,099
|
)
|
|
244,270
|
|
|
608,892
|
|
|||
(Decrease) increase in accounts payable, accrued expenses, and other liabilities
|
|
(23,188
|
)
|
|
253,980
|
|
|
303,657
|
|
|||
Total adjustments
|
|
108,601
|
|
|
577,874
|
|
|
694,724
|
|
|||
Net cash provided by operating activities
|
|
1,307,112
|
|
|
1,473,396
|
|
|
1,330,780
|
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable and other securities
|
|
(1,277,140
|
)
|
|
(809,419
|
)
|
|
(557,105
|
)
|
|||
Sales or maturities of marketable securities
|
|
544,584
|
|
|
274,456
|
|
|
327,437
|
|
|||
Capital expenditures
|
|
(272,626
|
)
|
|
(511,941
|
)
|
|
(677,933
|
)
|
|||
Net cash used in investing activities
|
|
(1,005,182
|
)
|
|
(1,046,904
|
)
|
|
(907,601
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||||||
Proceeds in connection with capital and facility lease obligations
|
|
57,000
|
|
|
5,085
|
|
|
27,373
|
|
|||
Payments in connection with capital and facility lease obligations
|
|
(19,925
|
)
|
|
(32,774
|
)
|
|
(1,353
|
)
|
|||
Repayments of convertible senior notes
|
|
—
|
|
|
(12,894
|
)
|
|
(166,467
|
)
|
|||
Payments in connection with reduction of outstanding warrants
|
|
—
|
|
|
(643,365
|
)
|
|
(573,487
|
)
|
|||
Proceeds from issuance of Common Stock
|
|
240,213
|
|
|
126,739
|
|
|
206,358
|
|
|||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(301,688
|
)
|
|
(143,182
|
)
|
|
(160,537
|
)
|
|||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
—
|
|
|
405,317
|
|
|||
Net cash used in financing activities
|
|
(24,400
|
)
|
|
(700,391
|
)
|
|
(262,796
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net increase (decrease) in cash and cash equivalents
|
|
277,530
|
|
|
(273,899
|
)
|
|
160,383
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at beginning of period
|
|
535,203
|
|
|
809,102
|
|
|
648,719
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at end of period
|
|
$
|
812,733
|
|
|
$
|
535,203
|
|
|
$
|
809,102
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest (net of amounts capitalized)
|
|
$
|
18,678
|
|
|
$
|
5,454
|
|
|
$
|
10,582
|
|
Cash paid for income taxes
|
|
$
|
754,843
|
|
|
$
|
481,360
|
|
|
$
|
276,092
|
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
•
|
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
|
|
10–50 years
|
Laboratory and other equipment
|
|
3–10 years
|
Furniture and fixtures
|
|
5 years
|
|
|
Year Ended December 31,
|
||||||||||
Net Product Sales in the United States
|
|
2017
|
|
2016
|
|
2015
|
||||||
EYLEA
|
|
$
|
3,701,917
|
|
|
$
|
3,323,081
|
|
|
$
|
2,676,040
|
|
ARCALYST
|
|
16,546
|
|
|
15,309
|
|
|
13,438
|
|
|||
Net Product Sales
|
|
$
|
3,718,463
|
|
|
$
|
3,338,390
|
|
|
$
|
2,689,478
|
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Besse Medical, a subsidiary of AmerisourceBergen Corporation
|
51
|
%
|
|
55
|
%
|
|
67
|
%
|
McKesson Corporation
|
29
|
%
|
|
28
|
%
|
|
26
|
%
|
Curascript SD Specialty Distribution, a subsidiary of Express Scripts
|
19
|
%
|
|
16
|
%
|
|
**
|
|
|
Rebates &
Chargebacks
|
|
Distribution-
Related
Fees
|
|
Other Sales-
Related
Deductions
|
|
Total
|
||||||||
Balance as of December 31, 2014
|
$
|
3,083
|
|
|
$
|
21,166
|
|
|
$
|
532
|
|
|
$
|
24,781
|
|
Provisions
|
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
|
|
||||
Provisions
|
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
|
|
||||
Provisions
|
167,755
|
|
|
194,132
|
|
|
46,383
|
|
|
408,270
|
|
||||
Credits/payments
|
(150,627
|
)
|
|
(189,455
|
)
|
|
(28,737
|
)
|
|
(368,819
|
)
|
||||
Balance as of December 31, 2017
|
$
|
29,840
|
|
|
$
|
34,142
|
|
|
$
|
21,320
|
|
|
$
|
85,302
|
|
|
|
Year Ended December 31,
|
||||||||||
Sanofi Collaboration Revenue
|
|
2017
|
|
2016
|
|
2015
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
508,364
|
|
|
$
|
564,900
|
|
|
$
|
735,439
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
368,859
|
|
|
305,947
|
|
|
155,271
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(442,610
|
)
|
|
(459,058
|
)
|
|
(240,042
|
)
|
|||
Other
|
|
119,076
|
|
|
28,379
|
|
|
12,322
|
|
|||
Total Antibody
|
|
553,689
|
|
|
440,168
|
|
|
662,990
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
239,981
|
|
|
138,497
|
|
|
39,961
|
|
|||
Other
|
|
83,523
|
|
|
80,000
|
|
|
40,000
|
|
|||
Total Immuno-oncology
|
|
323,504
|
|
|
218,497
|
|
|
79,961
|
|
|||
ZALTRAP:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
—
|
|
|
—
|
|
|
686
|
|
|||
Other
|
|
—
|
|
|
—
|
|
|
15,236
|
|
|||
Total ZALTRAP
|
|
—
|
|
|
—
|
|
|
15,922
|
|
|||
|
|
$
|
877,193
|
|
|
$
|
658,665
|
|
|
$
|
758,873
|
|
|
|
As of December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Antibody:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
121,001
|
|
|
$
|
47,268
|
|
Deferred revenue
|
|
$
|
117,682
|
|
|
$
|
98,741
|
|
|
|
|
|
|
||||
Immuno-oncology:
|
|
|
|
|
||||
Accounts receivable, net
|
|
$
|
59,274
|
|
|
$
|
40,647
|
|
Deferred revenue
|
|
$
|
440,000
|
|
|
$
|
520,000
|
|
|
|
Year Ended December 31,
|
||||||||||
Bayer Collaboration Revenue
|
|
2017
|
|
2016
|
|
2015
|
||||||
EYLEA:
|
|
|
|
|
|
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
802,298
|
|
|
$
|
649,232
|
|
|
$
|
466,667
|
|
Sales milestones
|
|
—
|
|
|
—
|
|
|
15,000
|
|
|||
Reimbursement of Regeneron EYLEA development expenses
|
|
13,325
|
|
|
9,010
|
|
|
8,887
|
|
|||
Other
|
|
58,634
|
|
|
52,527
|
|
|
69,466
|
|
|||
Total EYLEA
|
|
874,257
|
|
|
710,769
|
|
|
560,020
|
|
|||
Ang2 antibody and PDGFR-beta antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of development expenses
|
|
17,841
|
|
|
18,327
|
|
|
10,075
|
|
|||
Other
|
|
45,954
|
|
|
15,174
|
|
|
10,393
|
|
|||
Total Ang2 antibody and PDGFR-beta antibody
|
|
63,795
|
|
|
33,501
|
|
|
20,468
|
|
|||
|
|
$
|
938,052
|
|
|
$
|
744,270
|
|
|
$
|
580,488
|
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
As of December 31, 2017
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate bonds
|
|
$
|
1,717,976
|
|
|
$
|
2,176
|
|
|
$
|
(7,672
|
)
|
|
$
|
1,712,480
|
|
U.S. government and government agency obligations
|
|
186,699
|
|
|
34
|
|
|
(1,241
|
)
|
|
185,492
|
|
||||
Municipal bonds
|
|
4,600
|
|
|
—
|
|
|
(13
|
)
|
|
4,587
|
|
||||
Commercial paper
|
|
106,973
|
|
|
—
|
|
|
—
|
|
|
106,973
|
|
||||
Certificates of deposit
|
|
11,024
|
|
|
—
|
|
|
—
|
|
|
11,024
|
|
||||
Equity securities
|
|
56,191
|
|
|
6,594
|
|
|
—
|
|
|
62,785
|
|
||||
|
|
$
|
2,083,463
|
|
|
$
|
8,804
|
|
|
$
|
(8,926
|
)
|
|
$
|
2,083,341
|
|
As of December 31, 2016
|
|
|
|
|
|
|
|
|
||||||||
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,
|
||||||
|
|
2017
|
|
2016
|
||||
Maturities within one year
|
|
$
|
593,783
|
|
|
$
|
503,481
|
|
Maturities after one year through five years
|
|
1,426,773
|
|
|
815,041
|
|
||
|
|
$
|
2,020,556
|
|
|
$
|
1,318,522
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
As of December 31, 2017
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
$
|
930,970
|
|
|
$
|
(4,924
|
)
|
|
$
|
256,750
|
|
|
$
|
(2,748
|
)
|
|
$
|
1,187,720
|
|
|
$
|
(7,672
|
)
|
U.S. government and government agency obligations
|
110,532
|
|
|
(409
|
)
|
|
67,921
|
|
|
(832
|
)
|
|
178,453
|
|
|
(1,241
|
)
|
||||||
Municipal bonds
|
2,582
|
|
|
(10
|
)
|
|
2,005
|
|
|
(3
|
)
|
|
4,587
|
|
|
(13
|
)
|
||||||
|
$
|
1,044,084
|
|
|
$
|
(5,343
|
)
|
|
$
|
326,676
|
|
|
$
|
(3,583
|
)
|
|
$
|
1,370,760
|
|
|
$
|
(8,926
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
As of December 31, 2016
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
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
|
)
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||
As of December 31, 2017
|
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
|
$
|
1,712,480
|
|
|
—
|
|
|
$
|
1,712,480
|
|
|
U.S. government and government agency obligations
|
185,492
|
|
|
—
|
|
|
185,492
|
|
|||
Municipal bonds
|
4,587
|
|
|
—
|
|
|
4,587
|
|
|||
Commercial paper
|
106,973
|
|
|
—
|
|
|
106,973
|
|
|||
Certificates of deposit
|
11,024
|
|
|
—
|
|
|
11,024
|
|
|||
Equity securities
|
62,785
|
|
|
$
|
62,785
|
|
|
—
|
|
||
|
$
|
2,083,341
|
|
|
$
|
62,785
|
|
|
$
|
2,020,556
|
|
|
|
|
|
|
|
||||||
As of December 31, 2016
|
|
|
|
|
|
||||||
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
|
|
|
Notional Amount
|
||
Interest rate swap contracts
|
$
|
75,000
|
|
Interest rate cap contracts
|
$
|
75,000
|
|
|
As of December 31,
|
||||||
|
2017
|
|
2016
|
||||
Land
|
$
|
192,757
|
|
|
$
|
103,906
|
|
Building and improvements
|
1,441,565
|
|
|
1,278,283
|
|
||
Leasehold improvements
|
102,599
|
|
|
101,101
|
|
||
Construction-in-progress
|
408,857
|
|
|
318,929
|
|
||
Laboratory and other equipment
|
599,153
|
|
|
554,181
|
|
||
Furniture, computer and office equipment, and other
|
179,968
|
|
|
152,525
|
|
||
|
2,924,899
|
|
|
2,508,925
|
|
||
Less, accumulated depreciation and amortization
|
(566,294
|
)
|
|
(425,504
|
)
|
||
|
$
|
2,358,605
|
|
|
$
|
2,083,421
|
|
|
As of December 31,
|
||||||
|
2017
|
|
2016
|
||||
Accounts payable
|
$
|
178,183
|
|
|
$
|
134,984
|
|
Accrued payroll and related costs
|
191,825
|
|
|
153,086
|
|
||
Accrued clinical trial expense
|
120,891
|
|
|
91,753
|
|
||
Accrued sales-related charges, deductions, and royalties
|
194,542
|
|
|
159,985
|
|
||
Income taxes payable
|
227
|
|
|
235,776
|
|
||
Other accrued expenses and liabilities
|
129,410
|
|
|
103,512
|
|
||
|
$
|
815,078
|
|
|
$
|
879,096
|
|
|
As of December 31,
|
||||||
|
2017
|
|
2016
|
||||
Current portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
177,746
|
|
|
$
|
115,267
|
|
Received or receivable from Bayer (see Note 3b)
|
39,000
|
|
|
31,084
|
|
||
Received or receivable from MTPC (see Note 3c)
|
14,027
|
|
|
9,188
|
|
||
Received or receivable from Teva (see Note 3d)
|
43,535
|
|
|
43,122
|
|
||
Received for technology license agreement (see Note 3h)
|
10,280
|
|
|
23,572
|
|
||
Other
|
35,550
|
|
|
9,431
|
|
||
|
$
|
320,138
|
|
|
$
|
231,664
|
|
Long-term portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
379,936
|
|
|
$
|
503,474
|
|
Received or receivable from Bayer (see Note 3b)
|
29,734
|
|
|
77,028
|
|
||
Received or receivable from MTPC (see Note 3c)
|
56,106
|
|
|
45,940
|
|
||
Received or receivable from Teva (see Note 3d)
|
153,823
|
|
|
194,050
|
|
||
Received for technology license agreement (see Note 3h)
|
—
|
|
|
10,280
|
|
||
Other
|
9,600
|
|
|
—
|
|
||
|
$
|
629,199
|
|
|
$
|
830,772
|
|
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2018
|
|
$
|
2,866
|
|
|
$
|
6,097
|
|
|
$
|
8,963
|
|
2019
|
|
3,095
|
|
|
817
|
|
|
3,912
|
|
|||
2020
|
|
2,713
|
|
|
426
|
|
|
3,139
|
|
|||
2021
|
|
2,386
|
|
|
45
|
|
|
2,431
|
|
|||
2022
|
|
1,901
|
|
|
26
|
|
|
1,927
|
|
|||
Thereafter
|
|
1,498
|
|
|
8
|
|
|
1,506
|
|
|||
|
|
$
|
14,459
|
|
|
$
|
7,419
|
|
|
$
|
21,878
|
|
Year Ended December 31,
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2017
|
|
$
|
3,138
|
|
|
$
|
1,151
|
|
|
$
|
4,289
|
|
2016
|
|
$
|
15,861
|
|
|
$
|
852
|
|
|
$
|
16,713
|
|
2015
|
|
$
|
14,659
|
|
|
$
|
543
|
|
|
$
|
15,202
|
|
|
|
Capital and Facility Lease Obligations
|
||
2018
|
|
$
|
21,085
|
|
2019
|
|
23,838
|
|
|
2020
|
|
26,257
|
|
|
2021
|
|
27,650
|
|
|
2022
|
|
6,837
|
|
|
Thereafter
|
|
—
|
|
|
|
|
$
|
105,667
|
|
a.
|
Stock Options
|
|
|
Number of Shares
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term (in years)
|
|
Intrinsic Value
|
||||||
Outstanding as of December 31, 2016
|
|
25,136,027
|
|
|
$
|
269.69
|
|
|
|
|
|
|
||
2017:
|
Granted
|
|
4,235,015
|
|
|
$
|
383.56
|
|
|
|
|
|
||
|
Forfeited
|
|
(704,136
|
)
|
|
$
|
434.25
|
|
|
|
|
|
||
|
Expired
|
|
(100,727
|
)
|
|
$
|
505.96
|
|
|
|
|
|
||
|
Exercised
|
|
(2,360,806
|
)
|
|
$
|
122.92
|
|
|
|
|
|
||
Outstanding as of December 31, 2017
|
|
26,205,373
|
|
|
$
|
295.98
|
|
|
6.52
|
|
$
|
2,904,974
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vested and expected to vest as of December 31, 2017
|
|
24,667,723
|
|
|
$
|
293.65
|
|
|
6.46
|
|
$
|
2,904,723
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable as of December 31, 2017
|
|
16,263,766
|
|
|
$
|
223.00
|
|
|
5.08
|
|
$
|
2,894,474
|
|
|
|
Number of Options Granted
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Fair Value
|
|||||
2017:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
4,235,015
|
|
|
$
|
383.56
|
|
|
$
|
118.70
|
|
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
|
|
|
|
2017
|
|
2016
|
|
2015
|
|||
Expected volatility
|
|
31
|
%
|
|
34
|
%
|
|
35
|
%
|
Expected lives from grant date
|
|
5.1 years
|
|
|
5.1 years
|
|
|
5.1 years
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk-free interest rate
|
|
2.16
|
%
|
|
1.84
|
%
|
|
1.68
|
%
|
b.
|
Restricted Stock
|
|
|
Number of Shares
|
|
Weighted-Average Grant Date Fair Value
|
||||
Outstanding as of December 31, 2016
|
|
546,820
|
|
|
$
|
141.85
|
|
|
2017:
|
Granted
|
|
63,030
|
|
|
$
|
379.60
|
|
|
Vested
|
|
(501,590
|
)
|
|
$
|
115.07
|
|
|
Forfeited
|
|
(2,000
|
)
|
|
$
|
381.92
|
|
Outstanding as of December 31, 2017
|
|
106,260
|
|
|
$
|
404.72
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
United States
|
$
|
1,964,759
|
|
|
$
|
1,650,959
|
|
|
$
|
1,665,087
|
|
|
Foreign
|
113,752
|
|
|
(321,144
|
)
|
|
(439,990
|
)
|
||||
|
|
$
|
2,078,511
|
|
|
$
|
1,329,815
|
|
|
$
|
1,225,097
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Current:
|
|
|
|
|
|
|||||||
|
Federal
|
$
|
560,250
|
|
|
$
|
786,964
|
|
|
$
|
686,561
|
|
|
State
|
(4,086
|
)
|
|
8,769
|
|
|
28,568
|
|
|||
|
Foreign
|
4,827
|
|
|
(1,362
|
)
|
|
4,004
|
|
|||
|
Total current tax expense
|
560,991
|
|
|
794,371
|
|
|
719,133
|
|
|||
Deferred:
|
|
|
|
|
|
|||||||
|
Federal
|
317,064
|
|
|
(377,368
|
)
|
|
(119,849
|
)
|
|||
|
State
|
(1,258
|
)
|
|
13,431
|
|
|
(3,768
|
)
|
|||
|
Foreign
|
3,203
|
|
|
3,859
|
|
|
(6,475
|
)
|
|||
|
Total deferred tax expense (benefit)
|
319,009
|
|
|
(360,078
|
)
|
|
(130,092
|
)
|
|||
|
$
|
880,000
|
|
|
$
|
434,293
|
|
|
$
|
589,041
|
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
U.S. federal statutory tax rate
|
35.0
|
%
|
|
35.0
|
%
|
|
35.0
|
%
|
Impact of change in U.S. corporate tax rate (the Act)
|
15.7
|
|
|
—
|
|
|
—
|
|
Stock-based compensation
|
(9.0
|
)
|
|
(10.9
|
)
|
|
—
|
|
State and local income taxes
|
0.1
|
|
|
1.3
|
|
|
0.9
|
|
Taxation of non-U.S. operations
|
0.7
|
|
|
8.8
|
|
|
12.2
|
|
Income tax credits
|
(1.3
|
)
|
|
(1.2
|
)
|
|
(1.6
|
)
|
Non-deductible Branded Prescription Drug Fee
|
1.7
|
|
|
1.9
|
|
|
2.0
|
|
Domestic production activities deduction
|
(2.6
|
)
|
|
(2.8
|
)
|
|
(3.2
|
)
|
Other permanent differences
|
2.0
|
|
|
0.6
|
|
|
2.8
|
|
Effective income tax rate
|
42.3
|
%
|
|
32.7
|
%
|
|
48.1
|
%
|
|
|
As of December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Deferred revenue
|
|
$
|
102,441
|
|
|
$
|
214,587
|
|
Deferred compensation
|
|
391,034
|
|
|
515,984
|
|
||
Fixed assets and intangible assets
|
|
—
|
|
|
21,139
|
|
||
Accrued expenses
|
|
38,312
|
|
|
37,188
|
|
||
Other
|
|
26,387
|
|
|
49,100
|
|
||
|
|
558,174
|
|
|
837,998
|
|
||
Valuation allowance
|
|
(4,187
|
)
|
|
(3,420
|
)
|
||
Total deferred tax assets
|
|
553,987
|
|
|
834,578
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
||||
Fixed assets and intangible assets
|
|
(44,629
|
)
|
|
—
|
|
||
Other
|
|
(3,067
|
)
|
|
(9,275
|
)
|
||
Total deferred tax liabilities
|
|
(47,696
|
)
|
|
(9,275
|
)
|
||
Net deferred tax assets
|
|
$
|
506,291
|
|
|
$
|
825,303
|
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Balance as of January 1
|
|
$
|
117,166
|
|
|
$
|
116,572
|
|
|
$
|
57,615
|
|
Gross increases related to current year tax positions
|
|
49,028
|
|
|
45,575
|
|
|
59,909
|
|
|||
Gross decreases related to prior year tax positions
|
|
(5,606
|
)
|
|
(42,284
|
)
|
|
(952
|
)
|
|||
Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation
|
|
(14,430
|
)
|
|
(2,697
|
)
|
|
—
|
|
|||
Balance as of December 31
|
|
$
|
146,158
|
|
|
$
|
117,166
|
|
|
$
|
116,572
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Net income - basic
|
|
$
|
1,198,511
|
|
|
$
|
895,522
|
|
|
$
|
636,056
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Convertible senior notes - interest expense and amortization of discount and note issuance costs
|
|
—
|
|
|
397
|
|
|
—
|
|
|||
Net income - diluted
|
|
$
|
1,198,511
|
|
|
$
|
895,919
|
|
|
$
|
636,056
|
|
|
|
|
|
|
|
|
||||||
(Shares in thousands)
|
|
|
|
|
|
|
||||||
Weighted average shares - basic
|
|
106,338
|
|
|
104,719
|
|
|
103,061
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
9,132
|
|
|
10,177
|
|
|
9,446
|
|
|||
Restricted stock
|
|
484
|
|
|
474
|
|
|
477
|
|
|||
Convertible senior notes
|
|
—
|
|
|
61
|
|
|
—
|
|
|||
Warrants
|
|
—
|
|
|
936
|
|
|
2,246
|
|
|||
Dilutive potential shares
|
|
9,616
|
|
|
11,648
|
|
|
12,169
|
|
|||
Weighted average shares - diluted
|
|
115,954
|
|
|
116,367
|
|
|
115,230
|
|
|||
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
11.27
|
|
|
$
|
8.55
|
|
|
$
|
6.17
|
|
Net income per share - diluted
|
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
|
Year Ended December 31,
|
|||||||
(Shares in thousands)
|
|
2017
|
|
2016
|
|
2015
|
|||
Stock options
|
|
9,161
|
|
|
8,041
|
|
|
1,343
|
|
Restricted stock
|
|
—
|
|
|
19
|
|
|
—
|
|
Convertible senior notes
|
|
—
|
|
|
—
|
|
|
994
|
|
|
|
First Quarter Ended
March 31, 2017
|
|
Second Quarter Ended
June 30, 2017
*
|
|
Third Quarter Ended
September 30, 2017
|
|
Fourth Quarter Ended
December 31, 2017
**
|
||||||||
Revenues
|
|
$
|
1,318,991
|
|
|
$
|
1,470,116
|
|
|
$
|
1,500,673
|
|
|
$
|
1,582,447
|
|
Net income
|
|
$
|
248,931
|
|
|
$
|
387,744
|
|
|
$
|
388,317
|
|
|
$
|
173,519
|
|
Net income per share - basic
|
|
$
|
2.36
|
|
|
$
|
3.66
|
|
|
$
|
3.64
|
|
|
$
|
1.62
|
|
Net income per share - diluted
|
|
$
|
2.16
|
|
|
$
|
3.34
|
|
|
$
|
3.32
|
|
|
$
|
1.50
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
First Quarter Ended
March 31, 2016
***
|
|
Second Quarter Ended
June 30, 2016
|
|
Third Quarter Ended
September 30, 2016
|
|
Fourth Quarter Ended
December 31, 2016
|
||||||||
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
|
|
|
|
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
ID:
[
]
|
|
Notice of Grant of Stock Options
|
777 Old Saw Mill River Road
|
|
and Option Agreement for Time-Based Vesting
|
Tarrytown, New York 10591
|
|
Option Awards
|
|
|
|
||
|
||
[OPTIONEE NAME]
|
Option Number:
|
[
]
|
[OPTIONEE ADDRESS]
|
Plan:
|
[
]
|
|
ID
|
[
]
|
|
|
|
You and the Company agree that these options are granted under and governed by the terms and conditions of the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long Term Incentive Plan, as amended from time to time, and the enclosed Option Agreement, both of which are attached and made a part of this document.
|
|
**
|
|
Options for executive officers will vest in approximately equal annual 25% installments. Full Vest Dates will occur on the first, second, third and fourth anniversaries of the Grant Date.
|
|
|
|||
***
|
|
Date to be 10 years from the Grant Date.
|
|
|
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
ID:
[
]
|
|
Notice of Grant of Stock Options
|
777 Old Saw Mill River Road
|
|
and Option Agreement for Time Vesting
|
Tarrytown, New York 10591
|
|
Option Awards
|
|
|
|
||
|
||
[OPTIONEE NAME]
|
Option Number:
|
[
]
|
[OPTIONEE ADDRESS]
|
Plan:
|
[
]
|
|
ID
|
[
]
|
|
Shares
|
|
Vest Type
|
|
Full Vest
|
|
Expiration Date
|
**
|
|
On Vest Date
|
|
[__/__/__]**
|
|
[10 years from Grant Date]
|
**
|
|
On Vest Date
|
|
[__/__/__]**
|
|
[10 years from Grant Date]
|
**
|
|
On Vest Date
|
|
[__/__/__]**
|
|
[10 years from Grant Date]
|
**
|
|
On Vest Date
|
|
[__/__/__]**
|
|
[10 years from Grant Date]
|
|
|
|
|
|
|
|
The Incentive Stock Option expires on [ ]*** (the “Expiration Date”).
|
|
|
You and the Company agree that these options are granted under and governed by the terms and conditions of the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long Term Incentive Plan, as amended from time to time, and the enclosed Option Agreement, both of which are attached and made a part of this document.
|
|
**
|
|
Options for executive officers will vest in approximately equal annual 25% installments. Full Vest Dates will occur on the first, second, third and fourth anniversaries of the Grant Date.
|
|
||
***
|
|
Date to be 10 years from the Grant Date.
|
|
Regeneron Pharmaceuticals, Inc.
|
||
|
ID:
[
]
|
||
Notice of Grant of Stock Options
|
777 Old Saw Mill River Road
|
||
and Option Agreement for Time-Based Vesting
|
Tarrytown, New York 10591
|
||
Option Awards
|
|
||
|
|
|
|
[OPTIONEE NAME]
|
Option Number:
|
[
]
|
|
[OPTIONEE ADDRESS]
|
Plan:
|
[
]
|
|
|
ID
|
[
]
|
Shares
|
|
Vest Type
|
|
Full Vest
|
|
Expiration Date
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
Options will vest in approximately equal annual 25% installments. Full Vest Dates will occur on the first, second, third and fourth anniversaries of the Grant Date.
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
ID:
[ ]
|
|
Notice of Grant of Stock Options
|
777 Old Saw Mill River Road
|
|
and Option Agreement for Time Vesting
|
Tarrytown, New York 10591
|
|
Option Awards
|
|
|
|
|
|
[OPTIONEE NAME]
|
Option Number:
|
[
]
|
[OPTIONEE ADDRESS]
|
Plan:
|
[
]
|
|
ID
|
[
]
|
Shares
|
|
Vest Type
|
|
Full Vest
|
|
Expiration Date
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
|
On Vest Date
|
|
[ / / ]*
|
|
[10 years from Grant Date]
|
*
|
Options will vest in approximately equal annual 25% installments. Full Vest Dates will occur on the first, second, third and fourth anniversaries of the Grant Date.
|
|
|
|
Regeneron Pharmaceuticals, Inc.
|
|
ID: [ ]
|
Notice of Grant of Award
|
777 Old Saw Mill River Road
|
And Award Agreement
|
Tarrytown, New York 10591
|
[NAME]
|
Award Number:
|
[ ]
|
[ADDRESS]
|
Plan:
|
[ ]
|
Shares
|
|
Full Vest
|
||
[ ]*
|
|
|
[ ]*
|
|
[ ]*
|
|
|
[ ]*
|
|
[ ]*
|
|
|
[ ]*
|
|
|
|
|
||
|
|
Regeneron Pharmaceuticals, Inc.
|
||
Notice of Grant of Stock Options
|
|
ID:
[ ]
|
||
and Option Agreement
|
|
777 Old Saw Mill River Road
|
||
|
|
Tarrytown, New York 10591
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[OPTIONEE NAME]
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Option Number:
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[ ]
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[OPTIONEE ADDRESS]
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Plan:
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[ ]
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ID
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[ ]
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Shares
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Vest Type
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Full Vest
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Expiration Date
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*
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On Vest Date
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[ / / ]*
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[10 years from Grant Date]
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*
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On Vest Date
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[ / / ]*
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[10 years from Grant Date]
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*
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On Vest Date
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[ / / ]*
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[10 years from Grant Date]
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*
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Options for non-employee directors will vest in approximately equal annual 33-1/3% installments. Full Vest Dates will occur on the first, second, and third anniversaries of the Grant Date.
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Name of Subsidiary*
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State or Other Jurisdiction of Incorporation or Organization
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Loop Road Holdings LLC
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New York
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Old Saw Mill Holdings LLC
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New York
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OSMR Holdings
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Bermuda
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OSMR International
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Bermuda
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Regeneron Assurance, Inc.
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New York
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Regeneron Belgium BVBA
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Belgium
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Regeneron Capital International B.V.
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The Netherlands
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Regeneron Genetics Center LLC
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Delaware
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Regeneron Healthcare Solutions, Inc.
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New York
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Regeneron International Holdings LLC
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Delaware
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Regeneron International Unlimited Company
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Ireland
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Regeneron Ireland Holdings Unlimited Company
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Ireland
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Regeneron Ireland Unlimited Company
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Ireland
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Regeneron Spain, S.L.U.
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Spain
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Regeneron UK Limited
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United Kingdom
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Rockwood Road Holdings LLC
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New York
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_____________
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* Directly or indirectly wholly owned by Regeneron Pharmaceuticals, Inc.
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1.
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I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date:
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February 8, 2018
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/s/ Leonard S. Schleifer
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Leonard S. Schleifer, M.D., Ph.D.
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President and Chief Executive Officer
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(Principal Executive Officer)
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1.
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I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date:
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February 8, 2018
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/s/ Robert E. Landry
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Robert E. Landry
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Senior Vice President, Finance and Chief Financial Officer
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(Principal Financial Officer)
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(1)
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Leonard S. Schleifer
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Leonard S. Schleifer, M.D., Ph.D.
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President and Chief Executive Officer
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(Principal Executive Officer)
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February 8, 2018
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/s/ Robert E. Landry
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Robert E. Landry
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Senior Vice President, Finance and Chief Financial Officer
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(Principal Financial Officer)
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February 8, 2018
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