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, 2018
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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 Section 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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ý
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No
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¨
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Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files).
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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 disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 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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¨
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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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ý
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Accelerated filer
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¨
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Non-accelerated filer
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¨
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Smaller reporting company
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¨
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Emerging growth company
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¨
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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 Act).
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Yes
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¨
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No
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ý
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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 $35,741,000,000, computed by reference to the closing sales price of the stock on NASDAQ on June 29, 2018, 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 January 31, 2019:
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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, $.001 par value
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107,365,835
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DOCUMENTS INCORPORATED BY REFERENCE
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Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its 2019 Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages 78 to 83 of this filing.
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Page Numbers
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"ARCALYST
®
", "EYLEA
®
", "Libtayo
®
" (in the United States), "Regeneron
®
", "Regeneron Genetics Center
®
", "
Veloci-Bi
TM
", "
VelociGene
®
", "
VelociMab
®
", "
VelocImmune
®
", "
VelociMouse
®
", "
VelociSuite
®
", and "ZALTRAP
®
" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners.
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Year Ended December 31,
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(In millions, except per share data)
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2018
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2017
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2016
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Revenues
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$
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6,710.8
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$
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5,872.2
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$
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4,860.4
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Net income
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$
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2,444.4
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$
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1,198.5
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$
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895.5
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Net income per share - diluted
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$
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21.29
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$
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10.34
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$
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7.70
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Product
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Disease Area
(1)
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Territory
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U.S.
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EU
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Japan
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Certain other countries outside the U.S.
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EYLEA (aflibercept) Injection
(2)
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Neovascular age-related macular degeneration (wet AMD)
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a
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a
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a
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a
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Diabetic macular edema (DME)
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a
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a
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a
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a
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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)
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a
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a
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a
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a
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Myopic choroidal neovascularization (mCNV)
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a
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a
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a
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Diabetic retinopathy in patients with DME
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a
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Dupixent (dupilumab) Injection
(3)
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Atopic dermatitis (in adults)
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a
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a
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a
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a
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Asthma (in adults and adolescents)
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a
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Praluent (alirocumab) Injection
(3)
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Heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) (in adults)
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a
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a
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a
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a
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Kevzara (sarilumab) Solution for Subcutaneous Injection
(3)
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Rheumatoid arthritis (RA) (in adults)
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a
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a
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a
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a
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Libtayo (cemiplimab) Injection
(3)(5)
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Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)
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a
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ARCALYST
®
(rilonacept) Injection for Subcutaneous Use
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Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)
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a
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ZALTRAP
®
(ziv-aflibercept) Injection for Intravenous Infusion
(4)
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Metastatic colorectal cancer (mCRC)
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a
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a
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a
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a
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(1)
Refer to label information in each territory for specific indication
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(2)
In collaboration with Bayer (outside the United States)
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(3)
In collaboration with Sanofi
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(4)
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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(5)
Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States
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Clinical Program
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Phase 1
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Phase 2
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Phase 3
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Regulatory Review
(i)
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EYLEA
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Non-proliferative diabetic retinopathy (NPDR) in patients without DME
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Diabetic retinopathy (U.S.)
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Dupixent (dupilumab)
(a)
Antibody to IL-4R alpha subunit
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Grass allergy
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Atopic dermatitis in adolescents and pediatrics (6–11 years of age)
(d)
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Asthma in adults and adolescents (EU and Japan)
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Peanut allergy
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Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)
(d)
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Atopic dermatitis in adolescents (12–17 years of age) (U.S. and EU)
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Asthma in pediatrics (6–11 years of age)
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Auto-injector for 200 mg dose (U.S. and EU)
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Eosinophilic esophagitis (EOE) (Phase 2/3)
(c)
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Chronic rhinosinusitis with nasal polyposis (CRSwNP) (U.S.)
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Clinical Program
(continued)
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Phase 1
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Phase 2
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Phase 3
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Regulatory Review
(i)
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REGN3048-3051
(g)
Multi-antibody therapy to Middle East Respiratory Syndrome (MERS) virus
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MERS virus infection
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REGN3767
(f)
Antibody to LAG-3 protein
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Advanced cancers (administered alone or in combination with Libtayo)
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Pozelimab
(f)
(REGN3918)
Antibody to C5
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Paroxysmal nocturnal hemoglobinuria (PNH)
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REGN4461
Agonist antibody to leptin receptor (LEPR)
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Lipodystrophy and obesity
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REGN4018
(a)
Bispecific antibody targeting MUC16 and CD3
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Platinum-resistant ovarian cancer (administered alone or in combination with Libtayo)
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REGN4659
(f)
Antibody to CTLA4
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Advanced NSCLC (administered alone or in combination with Libtayo)
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REGN5069
Antibody to GFRα3
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Pain
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REGN5458
(a)
Bispecific antibody targeting BCMA and CD3
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Multiple myeloma
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(a)
In collaboration with Sanofi
|
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(b)
In collaboration with Teva and Mitsubishi Tanabe Pharma
|
||||
(c)
U.S. Food and Drug Administration (FDA) granted orphan drug designation
|
||||
(d)
FDA granted Breakthrough Therapy designation
|
||||
(e)
FDA granted Fast Track designation
|
||||
(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.
|
||||
(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 the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) are parties to agreements whereby HHS provides certain funding to support research, development, and manufacturing of these antibodies.
|
||||
(h)
Studied as monotherapy and in combination with other antibodies and treatments
|
||||
(i)
Regulatory application submitted. Information in this column relates to U.S., European Union (EU), and Japan submissions only.
|
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Clinical Program
(continued)
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2018 and 2019 Events to Date
|
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Select 2019 Milestones
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Dupixent (dupilumab; IL-4R Antibody) (continued)
|
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Initiated Phase 2/3 study in eosinophilic esophagitis
|
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Initiated Phase 2 study in peanut allergy
|
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Submitted sBLA for auto-injector for 200 mg dose
|
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Reported positive top-line results from both Phase 3 trials of patients with CRSwNP
|
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Submitted sBLA for CRSwNP
|
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Praluent (alirocumab; PCSK9 Antibody)
|
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Reported positive results from ODYSSEY OUTCOMES study
|
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FDA (target action date of April 28, 2019) and EMA decisions on applications for cardiovascular risk reduction
|
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Submitted sBLA and MAA variation for cardiovascular risk reduction
|
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European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for a new indication to reduce cardiovascular risk
|
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FDA decision on sBLA for first-line treatment of hyperlipidemia (target action date of April 29, 2019)
|
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Submitted sBLA for first-line treatment of hyperlipidemia
|
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Initiated Phase 3 pediatric studies in HeFH and HoFH
|
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FDA approved sBLA for use with apheresis
|
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Kevzara (sarilumab; IL-6R Antibody)
|
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FDA approved sBLA for single-dose pre-filled pen presentation
|
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Initiated Phase 2 study in sJIA
|
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Initiated Phase 3 study in polymyalgia rheumatica
|
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Initiated Phase 3 study in giant cell arteritis
|
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Libtayo (cemiplimab; PD-1 Antibody)
|
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EMA accepted for review MAA for advanced CSCC
|
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Regulatory agency decision for advanced CSCC in the EU
|
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Positive results from pivotal trial in advanced CSCC published in the New England Journal of Medicine
|
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Continue patient enrollment in NSCLC and various other studies
|
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FDA approved BLA for the treatment of advanced CSCC
|
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Reported positive results from Phase 1 study in advanced NSCLC
|
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Initiated additional Phase 3 studies in advanced NSCLC
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Fasinumab (NGF Antibody)
|
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Completed patient enrollment in the efficacy sub-study of the Phase 3 long-term safety study in osteoarthritis
|
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Continue patient enrollment in Phase 3 long-term safety study and Phase 3 efficacy studies in osteoarthritis
|
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Independent Data Monitoring Committee (DMC) recommended higher dose-regimens be discontinued, and osteoarthritis trials modified accordingly
|
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Discontinued dosing in chronic low back pain in patients with concomitant osteoarthritis of the knee and hip
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Reported positive top-line results from first Phase 3 efficacy study in osteoarthritis
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Competitor
Product/Product
Candidate
|
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Commercial or
Development
Status
|
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Competitor
|
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Indication
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Territory
|
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
|
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
|
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
|
Conbercept
|
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Approved in China for wet AMD
In development in the United States and the EU (two non-inferiority Phase 3 trials comparing dosing regimens of conbercept to EYLEA initiated in 2018)
|
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Chengdu Kanghong Pharmaceutical Group Co., Ltd.
|
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Wet AMD
|
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China
|
EYLEA (continued)
|
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Competitor
Product/Product Candidate |
|
Commercial or
Development Status |
|
Competitor
|
|
Indication
|
|
Territory
|
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)
|
|
Novartis
|
|
Wet AMD and related conditions
|
|
—
|
Abicipar pegol (anti-VEGF-A-DARPin
®
)
|
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In development (two non-inferiority Phase 3 trials comparing dosing regimens of abicipar pegol and Lucentis reported to have met their primary endpoints in July 2018)
|
|
Allergan
|
|
Wet AMD and related conditions
|
|
—
|
Faricimab (RG7716), a bi-specific antibody targeting anti-VEGF and Ang2
|
|
In development (two non-inferiority Phase 3 trials comparing dosing regimens of faricimab and EYLEA in DME reported to have been initiated in September 2018)
|
|
Genentech/Roche
|
|
Wet AMD, DME
|
|
—
|
Ranibizumab port delivery system
|
|
In development (non-inferiority Phase 3 trial comparing ranibizumab administered via the Port Delivery System and monthly intravitreal injections of Lucentis in wet AMD reported to have been initiated in September 2018)
|
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Genentech/Roche
|
|
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
|
|
—
|
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
|
|
—
|
PAN-90806, a topically administered tyrosine kinase inhibitor
|
|
In development (Phase 1/2)
|
|
PanOptica, Inc.
|
|
Wet AMD
|
|
—
|
KSI-301, an anti-VEGF biologic therapy that is conjugated to a phosphorylcholine-based biopolymer to extend its half-life
|
|
In development (Phase 1b)
|
|
Kodiak Sciences Inc.
|
|
Wet AMD, DME, and RVO
|
|
—
|
RGX-314, a gene therapy
|
|
In development (Phase 1)
|
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REGENXBIO Inc.
|
|
Wet AMD
|
|
—
|
|
|
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EYLEA (continued)
|
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Competitor
Product/Product Candidate |
|
Commercial or
Development Status |
|
Competitor
|
|
Indication
|
|
Territory
|
M710, a biosimilar to EYLEA
|
|
In development (Phase 3)
|
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Momenta Pharmaceuticals, Inc. (in partnership with Mylan N.V.)
|
|
Wet AMD and related conditions
|
|
—
|
PF582, a biosimilar to Lucentis
|
|
In development (Phase 1/2 completed in August 2016)
|
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Pfenex Inc.
|
|
Wet AMD and related conditions
|
|
—
|
FYB201, a biosimilar to Lucentis
|
|
In development (Phase 3 trial of FYB201 and Lucentis completed in December 2018)
|
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Formycon AG (in collaboration with Bioeq GmbH)
|
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Wet AMD and related conditions
|
|
—
|
SB11, a biosimilar to Lucentis
|
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In development (Phase 3)
|
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Samsung Bioepis Co., Ltd.
|
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Wet AMD and related conditions
|
|
—
|
Razumab, a biosimilar to Lucentis
|
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Approved in India for wet AMD and related conditions
|
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Intas Phamaceuticals Limited
|
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Wet AMD and related conditions
|
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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
|
|
GlaxoSmithKline (GSK)
|
|
Asthma
|
|
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 (recently reported to have met the primary endpoints of two atopic dermatitis Phase 3 studies)
|
|
Eli Lilly and Company/Incyte Corporation
|
|
Atopic dermatitis
|
|
—
|
Abrocitinib (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 for asthma and Phase 2 for atopic dermatitis)
|
|
Amgen Inc./AstraZeneca
|
|
Asthma and atopic dermatitis
|
|
—
|
Etiokimab (ANB-020), an anti-IL-33 antibody
|
|
In development (Phase 2)
|
|
AnaptysBio, Inc.
|
|
Asthma and atopic dermatitis
|
|
—
|
|
|
|
|
|
|
|
|
|
Dupixent (continued)
|
||||||||
Competitor
Product/Product Candidate |
|
Commercial or
Development Status |
|
Competitor
|
|
Indication
|
|
Territory
|
Lebrikizumab, an anti-IL-13 antibody
|
|
In development (Phase 2b)
|
|
Dermira, Inc./Roche
|
|
Atopic dermatitis
|
|
—
|
Nemolizumab, an anti-IL-31R antibody
|
|
In development (Phase 2b reported to have been completed; Phase 3 initiation expected in 2019)
|
|
Galderma S.A.
|
|
Atopic dermatitis
|
|
—
|
GSK3772847, an anti-ST2 antibody
|
|
In development (Phase 2 for asthma and Phase 1 for atopic dermatitis)
|
|
GSK
|
|
Asthma and atopic dermatitis
|
|
—
|
RG6149, an anti-ST2 antibody
|
|
In development (Phase 2)
|
|
Roche
|
|
Asthma and atopic dermatitis
|
|
—
|
CSJ117, an inhaled antibody fragment against thymic stromal lymphopoietin
|
|
In development (Phase 1)
|
|
Novartis
|
|
Asthma
|
|
—
|
GBR-830, an anti-OX40 antibody
|
|
In development (Phase 2b)
|
|
Glenmark Pharmaceuticals Ltd.
|
|
Atopic dermatitis
|
|
—
|
KHK4083, an anti-OX40 antibody
|
|
In development (Phase 2)
|
|
Kyowa Hakko Kirin Co., Ltd.
|
|
Atopic dermatitis
|
|
—
|
ASN002, an orally administered dual JAK/SYK inhibitor
|
|
In development (Phase 2b)
|
|
Asana BioSciences, LLC
|
|
Atopic dermatitis
|
|
—
|
ZPL389, an orally administered histamine H4 receptor agonist
|
|
In development (Phase 2)
|
|
Novartis
|
|
Atopic dermatitis
|
|
—
|
Bermekimab, an anti-IL-1alpha antibody
|
|
In development (Phase 2 completed)
|
|
XBiotech Inc.
|
|
Atopic dermatitis
|
|
—
|
MOR-106, an anti-IL-17C antibody
|
|
In development (Phase 2)
|
|
Novartis/
MorphoSys, AG
|
|
Atopic dermatitis
|
|
—
|
KPL-716, an antibody against the oncostatin M receptor beta
|
|
In development (Phase 1 reported to have been completed)
|
|
Kiniksa Pharmaceuticals, Ltd.
|
|
Atopic dermatitis
|
|
—
|
PRS-060, an inhaled anticalin targeting IL-4R
|
|
In development (Phase 1)
|
|
AstraZeneca/ Pieris Pharmaceuticals, Inc.
|
|
Asthma
|
|
—
|
ASLAN004, an antibody against the IL-13R alpha-1 subunit
|
|
In development (Phase 1)
|
|
ASLAN Pharmaceuticals
|
|
Atopic dermatitis
|
|
—
|
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 3)
|
|
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)
|
|
—
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
|
Indication
|
|
Territory
|
Actemra
®
(tocilizumab)
|
|
Approved
|
|
Genentech/Roche/ Chugai Pharmaceutical Co., Ltd.
|
|
Rheumatoid arthritis
|
|
Worldwide
|
Orencia
®
(abatacept)
|
|
Approved
|
|
Bristol-Myers Squibb
|
|
Rheumatoid arthritis
|
|
Worldwide
|
Xeljanz
®
(tofacitinib)
|
|
Approved
|
|
Pfizer
|
|
Rheumatoid arthritis
|
|
Worldwide
|
Olumiant
®
(baricitinib)
|
|
Approved
|
|
Eli Lilly/Incyte
|
|
Rheumatoid arthritis
|
|
United States, EU
|
Olokizumab, an anti-IL-6 antibody
|
|
In development (Phase 3)
|
|
R-Pharm
|
|
Rheumatoid arthritis
|
|
—
|
Upadacitinib, an orally administered JAK inhibitor
|
|
In development (Submitted for regulatory approval)
|
|
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
|
|
—
|
BCD-089, an anti-IL-6R antibody
|
|
In development (Phase 2)
|
|
BIOCAD
|
|
Rheumatoid arthritis
|
|
—
|
LusiNEX, a biosimilar to Actemra
|
|
In development (Phase 1 trials reported to have been completed)
|
|
Mycenax Biotech Inc.
|
|
Rheumatoid arthritis
|
|
—
|
BAT1806, a biosimilar to Actemra
|
|
In development (Phase 1)
|
|
Bio-Thera Solutions Ltd.
|
|
Rheumatoid arthritis
|
|
—
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
|
Indication
|
|
Territory
|
Opdivo
®
(nivolumab)
|
|
Approved
|
|
Bristol-Myers Squibb
|
|
Various Cancers
|
|
Worldwide
|
Keytruda
®
(pembrolizumab)
|
|
Approved
|
|
Merck & Co., Inc.
|
|
Various Cancers
|
|
Worldwide
|
Bavencio
®
(avelumab)
|
|
Approved
|
|
Pfizer/Merck
|
|
Various Cancers
|
|
Worldwide
|
Tecentriq
®
(atezolizumab)
|
|
Approved
|
|
Roche
|
|
Various Cancers
|
|
Worldwide
|
Imfinzi
®
(durvalumab)
|
|
Approved
|
|
AstraZeneca
|
|
Various Cancers
|
|
Worldwide
|
Spartalizumab (PDR001), an antibody against PD-1
|
|
In development (Phase 3)
|
|
Novartis
|
|
Various Cancers
|
|
—
|
Tislelizumab (BGB-A317), an antibody against PD-1
|
|
In development (Phase 3)
|
|
Celgene Corporation/
BeiGene Ltd.
|
|
Various Cancers
|
|
—
|
AGEN2034, an antibody against PD-1
|
|
In development (Phase 1/2)
|
|
Agenus Inc.
|
|
Various Cancers
|
|
—
|
Dostarlimab (TSR-042), an antibody against PD-1
|
|
In development (Phase 2/3)
|
|
GSK/
AnaptysBio
|
|
Various Cancers
|
|
—
|
INCMGA0012, an antibody against PD-1
|
|
In development (Phase 2)
|
|
Incyte/
MacroGenics, Inc.
|
|
Various Cancers
|
|
—
|
JNJ-63723283, an antibody against PD-1
|
|
In development (Phase 1/2)
|
|
Johnson & Johnson
|
|
Various Cancers
|
|
—
|
PF-06801591, an antibody against PD-1
|
|
In development (Phase 1)
|
|
Pfizer
|
|
Various Cancers
|
|
—
|
Regeneron Antibody
Program
|
|
Competitor
|
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Target
|
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
|
Evinacumab
|
|
Arrowhead Pharmaceuticals, Inc.
|
|
ARO-ANG3
|
|
In development (Phase 1)
|
|
RNAi against ANGPTL3
|
•
|
effectiveness of the commercial strategy in and outside the United States for the marketing of our products, including pricing strategy;
|
•
|
sufficient coverage of, and reimbursement for, our marketed 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, as well as payer restrictions on eligible patient populations and the reimbursement process, both in the United States and abroad;
|
•
|
our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA, 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;
|
•
|
maintaining and successfully monitoring commercial manufacturing arrangements for our marketed products with third parties who perform fill/finish or other steps in the manufacture of such products 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 our marketed products;
|
•
|
the outcome of the pending patent infringement proceedings relating to EYLEA, Dupixent, and Praluent (described further in Note 17 to our Consolidated Financial Statements included in this report), and other risks relating to our marketed products 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 results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and studies of other products that could implicate an entire class of products or are perceived to do so; and
|
•
|
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 prescribing practices.
|
•
|
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;
|
•
|
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 (as recorded by us or our collaborators), in particular EYLEA, Dupixent, and Libtayo, 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, Dupixent, and Libtayo;
|
•
|
whether our net product 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 (
i.e.
, a practice in which a pharmacist, a physician, or, in the case of an outsourcing facility, a person under the supervision of a pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient);
|
•
|
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
9.7%
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, 2018
, and
20.4%
of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by such persons which are exercisable within 60 days of
December 31, 2018
; and
|
•
|
our five largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately
44.4%
of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of
December 31, 2018
. In addition, these five shareholders plus our Chief Executive Officer held approximately
50.5%
of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of
December 31, 2018
.
|
•
|
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.
"
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
|
12/31/2017
|
|
12/31/2018
|
||||||||||||
Regeneron
|
$
|
100.00
|
|
|
$
|
149.05
|
|
|
$
|
197.24
|
|
|
$
|
133.37
|
|
|
$
|
136.59
|
|
|
$
|
135.70
|
|
S&P 500
|
$
|
100.00
|
|
|
$
|
111.39
|
|
|
$
|
110.58
|
|
|
$
|
121.13
|
|
|
$
|
144.65
|
|
|
$
|
135.63
|
|
NQ US Pharma TR Index
|
$
|
100.00
|
|
|
$
|
121.82
|
|
|
$
|
128.44
|
|
|
$
|
127.04
|
|
|
$
|
152.96
|
|
|
$
|
163.37
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||
(In millions, except per share data)
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
|
$
|
4,106.2
|
|
|
$
|
3,718.5
|
|
|
$
|
3,338.4
|
|
|
$
|
2,689.5
|
|
|
$
|
1,750.8
|
|
Sanofi and Bayer collaboration revenue
|
|
2,187.8
|
|
|
1,815.3
|
|
|
1,403.0
|
|
|
1,339.4
|
|
|
1,036.9
|
|
|||||
Other revenue
|
|
416.8
|
|
|
338.4
|
|
|
119.0
|
|
|
74.8
|
|
|
31.9
|
|
|||||
|
|
6,710.8
|
|
|
5,872.2
|
|
|
4,860.4
|
|
|
4,103.7
|
|
|
2,819.6
|
|
|||||
Expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
2,186.1
|
|
|
2,075.1
|
|
|
2,052.3
|
|
|
1,620.6
|
|
|
1,271.4
|
|
|||||
Selling, general, and administrative
|
|
1,556.2
|
|
|
1,320.4
|
|
|
1,177.7
|
|
|
838.5
|
|
|
519.3
|
|
|||||
Cost of goods sold
|
|
180.0
|
|
|
202.5
|
|
|
194.6
|
|
|
241.7
|
|
|
129.0
|
|
|||||
Cost of collaboration and contract manufacturing
|
|
254.1
|
|
|
194.6
|
|
|
105.1
|
|
|
151.0
|
|
|
76.0
|
|
|||||
|
|
4,176.4
|
|
|
3,792.6
|
|
|
3,529.7
|
|
|
2,851.8
|
|
|
1,995.7
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income from operations
|
|
2,534.4
|
|
|
2,079.6
|
|
|
1,330.7
|
|
|
1,251.9
|
|
|
823.9
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Other income (expense), net
|
|
19.1
|
|
|
(1.1
|
)
|
|
(0.9
|
)
|
|
(26.8
|
)
|
|
(62.7
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income before income taxes
|
|
2,553.5
|
|
|
2,078.5
|
|
|
1,329.8
|
|
|
1,225.1
|
|
|
761.2
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income tax expense
(1)
|
|
(109.1
|
)
|
|
(880.0
|
)
|
|
(434.3
|
)
|
|
(589.0
|
)
|
|
(423.1
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
$
|
895.5
|
|
|
$
|
636.1
|
|
|
$
|
338.1
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income per share - basic
|
|
$
|
22.65
|
|
|
$
|
11.27
|
|
|
$
|
8.55
|
|
|
$
|
6.17
|
|
|
$
|
3.36
|
|
Net income per share - diluted
|
|
$
|
21.29
|
|
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
$
|
5.52
|
|
|
$
|
2.98
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
As of December 31,
|
||||||||||||||||||
(In millions)
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents, and marketable securities (current and non-current)
|
|
$
|
4,564.9
|
|
|
$
|
2,896.0
|
|
|
$
|
1,902.9
|
|
|
$
|
1,677.4
|
|
|
$
|
1,360.6
|
|
Total assets
|
|
11,734.5
|
|
|
8,764.3
|
|
|
6,973.5
|
|
|
5,609.1
|
|
|
3,837.7
|
|
|||||
Convertible senior notes (current and non-current)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10.8
|
|
|
146.8
|
|
|||||
Capital and facility lease obligations (current and non-current)
|
|
708.5
|
|
|
703.5
|
|
|
481.1
|
|
|
364.7
|
|
|
312.3
|
|
|||||
Stockholders' equity
|
|
8,757.3
|
|
|
6,144.1
|
|
|
4,449.2
|
|
|
3,654.8
|
|
|
2,550.3
|
|
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.
|
|
Year Ended December 31,
|
||||||||||
(In millions, except per share data)
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues
|
$
|
6,710.8
|
|
|
$
|
5,872.2
|
|
|
$
|
4,860.4
|
|
Operating expenses
|
(4,176.4
|
)
|
|
(3,792.6
|
)
|
|
(3,529.7
|
)
|
|||
Other income (expense), net
|
19.1
|
|
|
(1.1
|
)
|
|
(0.9
|
)
|
|||
Income before income taxes
|
2,553.5
|
|
|
2,078.5
|
|
|
1,329.8
|
|
|||
Income tax expense
|
(109.1
|
)
|
|
(880.0
|
)
|
|
(434.3
|
)
|
|||
Net income
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
$
|
895.5
|
|
|
|
|
|
|
|
||||||
Net income per share - diluted
|
$
|
21.29
|
|
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||||||||||
(In millions)
|
2018
|
|
2017
|
|
2016
|
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||
Net product sales in the United States:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
EYLEA
|
$
|
4,076.7
|
|
|
$
|
3,701.9
|
|
|
$
|
3,323.1
|
|
|
$
|
374.8
|
|
|
$
|
378.8
|
|
Libtayo
|
14.8
|
|
|
—
|
|
|
—
|
|
|
14.8
|
|
|
—
|
|
|||||
ARCALYST
|
14.7
|
|
|
16.6
|
|
|
15.3
|
|
|
(1.9
|
)
|
|
1.3
|
|
|||||
Sanofi and Bayer collaboration revenue:
|
|
|
|
|
|
|
|
|
|
||||||||||
Sanofi
|
1,111.1
|
|
|
877.2
|
|
|
658.7
|
|
|
233.9
|
|
|
218.5
|
|
|||||
Bayer
|
1,076.7
|
|
|
938.1
|
|
|
744.3
|
|
|
138.6
|
|
|
193.8
|
|
|||||
Other revenue
|
416.8
|
|
|
338.4
|
|
|
119.0
|
|
|
78.4
|
|
|
219.4
|
|
|||||
Total revenues
|
$
|
6,710.8
|
|
|
$
|
5,872.2
|
|
|
$
|
4,860.4
|
|
|
$
|
838.6
|
|
|
$
|
1,011.8
|
|
(In millions)
|
Rebates, Chargebacks, and Discounts
|
|
Distribution-
Related Fees |
|
Other Sales-
Related Deductions |
|
Total
|
||||||||
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
|
|
||||
Provisions
|
223.4
|
|
|
211.0
|
|
|
44.5
|
|
|
478.9
|
|
||||
Credits/payments
|
(212.2
|
)
|
|
(203.1
|
)
|
|
(57.5
|
)
|
|
(472.8
|
)
|
||||
Balance as of December 31, 2018
|
$
|
41.1
|
|
|
$
|
42.0
|
|
|
$
|
8.3
|
|
|
$
|
91.4
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses - Discovery Agreement
|
|
—
|
|
|
$
|
130.0
|
|
|
$
|
130.0
|
|
|
Reimbursement of Regeneron research and development expenses - License and Collaboration Agreement
|
|
$
|
265.3
|
|
|
378.4
|
|
|
434.9
|
|
||
Reimbursement of Regeneron commercialization-related expenses
|
|
417.2
|
|
|
368.8
|
|
|
305.9
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(227.0
|
)
|
|
(442.6
|
)
|
|
(459.0
|
)
|
|||
Other
|
|
103.5
|
|
|
119.1
|
|
|
28.4
|
|
|||
Total Antibody
|
|
559.0
|
|
|
553.7
|
|
|
440.2
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses - Discovery Agreement
|
|
154.4
|
|
|
138.8
|
|
|
86.5
|
|
|||
Reimbursement of Regeneron research and development expenses - License and Collaboration Agreement
|
|
157.4
|
|
|
101.2
|
|
|
52.0
|
|
|||
Reimbursement of Regeneron commercialization-related expenses
|
|
8.9
|
|
|
7.0
|
|
|
—
|
|
|||
Other
|
|
231.4
|
|
|
76.5
|
|
|
80.0
|
|
|||
Total Immuno-oncology
|
|
552.1
|
|
|
323.5
|
|
|
218.5
|
|
|||
Total Sanofi collaboration revenue
|
|
$
|
1,111.1
|
|
|
$
|
877.2
|
|
|
$
|
658.7
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
992.3
|
|
|
$
|
802.3
|
|
|
$
|
649.2
|
|
Reimbursement of Regeneron development expenses
|
|
10.8
|
|
|
31.1
|
|
|
27.3
|
|
|||
Other
|
|
73.6
|
|
|
104.7
|
|
|
67.8
|
|
|||
Total Bayer collaboration revenue
|
|
$
|
1,076.7
|
|
|
$
|
938.1
|
|
|
$
|
744.3
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Net product sales outside the United States
|
|
$
|
2,668.9
|
|
|
$
|
2,226.9
|
|
|
$
|
1,872.3
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
$
|
1,045.9
|
|
|
$
|
856.1
|
|
|
$
|
703.3
|
|
Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation
|
|
(53.6
|
)
|
|
(53.8
|
)
|
|
(54.1
|
)
|
|||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
992.3
|
|
|
$
|
802.3
|
|
|
$
|
649.2
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Teva collaboration revenue:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
129.5
|
|
|
$
|
115.1
|
|
|
$
|
24.2
|
|
Other
|
|
115.1
|
|
|
106.4
|
|
|
13.7
|
|
|||
Total Teva collaboration revenue
|
|
244.6
|
|
|
221.5
|
|
|
37.9
|
|
|||
Other revenue
|
|
172.2
|
|
|
116.9
|
|
|
81.1
|
|
|||
Total other revenue
|
|
$
|
416.8
|
|
|
$
|
338.4
|
|
|
$
|
119.0
|
|
•
|
Recognition of a portion of deferred revenue from up-front and other payments received from MTPC, including a portion related to the achievement of a $20.0 million development milestone in the third quarter of 2018, and, in 2017, recognition of a substantive development milestone of $30.0 million from MTPC, in connection with our fasinumab collaboration.
|
•
|
Sanofi's reimbursement for manufacturing commercial supplies of ZALTRAP and a percentage of aggregate net sales of ZALTRAP under the terms of the Amended ZALTRAP Agreement.
|
•
|
Recognition of revenue related to the $165.0 million up-front payment we received in August 2010, which was deferred upon receipt and was being recognized as revenue through mid-2018, in connection with the
VelocImmune
license agreement with Astellas. In accordance with the terms of the license agreement, Astellas terminated the agreement effective June 2018.
|
•
|
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.
|
•
|
Recognition of revenue in connection with our agreement with BARDA to develop, test, and manufacture an antibody therapy (REGN3470-3471-3479) for the treatment of Ebola virus infection.
|
•
|
Recognition of revenue in connection with sequencing of samples by the RGC for its customers.
|
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||||||||||
(In millions, except headcount data)
|
|
2018
|
|
2017
|
|
2016
|
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||
Research and development
|
|
$
|
2,186.1
|
|
|
$
|
2,075.1
|
|
|
$
|
2,052.3
|
|
|
$
|
111.0
|
|
|
$
|
22.8
|
|
Selling, general, and administrative
|
|
1,556.2
|
|
|
1,320.4
|
|
|
1,177.7
|
|
|
235.8
|
|
|
142.7
|
|
|||||
Cost of goods sold
|
|
180.0
|
|
|
202.5
|
|
|
194.6
|
|
|
(22.5
|
)
|
|
7.9
|
|
|||||
Cost of collaboration and contract manufacturing
|
|
254.1
|
|
|
194.6
|
|
|
105.1
|
|
|
59.5
|
|
|
89.5
|
|
|||||
Total operating expenses
|
|
$
|
4,176.4
|
|
|
$
|
3,792.6
|
|
|
$
|
3,529.7
|
|
|
$
|
383.8
|
|
|
$
|
262.9
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Average headcount
|
|
6,906
|
|
|
5,780
|
|
|
4,927
|
|
|
1,126
|
|
|
853
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions, except effective tax rate)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Income tax expense
|
|
$
|
(109.1
|
)
|
|
$
|
(880.0
|
)
|
|
$
|
(434.3
|
)
|
Effective tax rate
|
|
4.3
|
%
|
|
42.3
|
%
|
|
32.7
|
%
|
|
As of December 31,
|
|
Increase
|
||||||||
(In millions)
|
2018
|
|
2017
|
|
(Decrease)
|
||||||
Financial assets:
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
1,467.7
|
|
|
$
|
812.7
|
|
|
$
|
655.0
|
|
Marketable securities - current
|
1,342.2
|
|
|
596.8
|
|
|
745.4
|
|
|||
Marketable securities - noncurrent
|
1,755.0
|
|
|
1,486.5
|
|
|
268.5
|
|
|||
|
$
|
4,564.9
|
|
|
$
|
2,896.0
|
|
|
$
|
1,668.9
|
|
|
|
|
|
|
|
||||||
Working capital:
|
|
|
|
|
|
||||||
Current assets
|
$
|
6,447.6
|
|
|
$
|
4,335.0
|
|
|
$
|
2,112.6
|
|
Current liabilities
|
1,442.8
|
|
|
1,135.5
|
|
|
307.3
|
|
|||
|
$
|
5,004.8
|
|
|
$
|
3,199.5
|
|
|
$
|
1,805.3
|
|
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||||||||||
(In millions)
|
|
2018
|
|
2017
|
|
2016
|
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||
Cash flows provided by operating activities
|
|
$
|
2,195.1
|
|
|
$
|
1,307.1
|
|
|
$
|
1,485.9
|
|
|
$
|
888.0
|
|
|
$
|
(178.8
|
)
|
Cash flows used in investing activities
|
|
$
|
(1,463.0
|
)
|
|
$
|
(1,005.2
|
)
|
|
$
|
(1,046.8
|
)
|
|
$
|
(457.8
|
)
|
|
$
|
41.6
|
|
Cash flows used in financing activities
|
|
$
|
(77.1
|
)
|
|
$
|
(24.4
|
)
|
|
$
|
(700.5
|
)
|
|
$
|
(52.7
|
)
|
|
$
|
676.1
|
|
(In millions)
|
|
Notional Amount
|
||
Interest rate swap contracts
|
|
$
|
75.0
|
|
Interest rate cap contracts
|
|
$
|
75.0
|
|
10.12.1*
|
|
10.13*
|
|
10.13.1*
|
|
10.13.2*
|
|
10.14
|
|
10.15*
|
|
10.16
|
|
10.17*
|
|
10.18*
|
|
10.19*
|
|
10.20*
|
|
10.21*
|
|
10.22*
|
|
10.23
|
|
10.24
|
10.25
|
|
10.26 +
|
|
10.27
|
|
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 7, 2019
|
|
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 7, 2019
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
/s/ ROBERT E. LANDRY
|
|
Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)
|
|
February 7, 2019
|
Robert E. Landry
|
|
|
|
|
/s/ CHRISTOPHER R. FENIMORE
|
|
Vice President, Controller (Principal Accounting Officer)
|
|
February 7, 2019
|
Christopher R. Fenimore
|
|
|
|
|
/s/ GEORGE D. YANCOPOULOS
|
|
President, Chief Scientific Officer, and Director
|
|
February 7, 2019
|
George D. Yancopoulos, M.D., Ph.D.
|
|
|
|
|
/s/ P. ROY VAGELOS
|
|
Chairman of the Board
|
|
February 7, 2019
|
P. Roy Vagelos, M.D.
|
|
|
|
|
/s/ BONNIE L. BASSLER
|
|
Director
|
|
February 7, 2019
|
Bonnie L. Bassler, Ph.D.
|
|
|
|
|
/s/ MICHAEL S. BROWN
|
|
Director
|
|
February 7, 2019
|
Michael S. Brown, M.D.
|
|
|
|
|
/s/ N. ANTHONY COLES
|
|
Director
|
|
February 7, 2019
|
N. Anthony Coles, M.D.
|
|
|
|
|
/s/ JOSEPH L. GOLDSTEIN
|
|
Director
|
|
February 7, 2019
|
Joseph L. Goldstein, M.D.
|
|
|
|
|
/s/ CHRISTINE A. POON
|
|
Director
|
|
February 7, 2019
|
Christine A. Poon
|
|
|
|
|
/s/ ARTHUR F. RYAN
|
|
Director
|
|
February 7, 2019
|
Arthur F. Ryan
|
|
|
|
|
/s/ GEORGE L. SING
|
|
Director
|
|
February 7, 2019
|
George L. Sing
|
|
|
|
|
/s/ MARC TESSIER-LAVIGNE
|
|
Director
|
|
February 7, 2019
|
Marc Tessier-Lavigne, Ph.D.
|
|
|
|
|
/s/ HUDA Y. ZOGHBI
|
|
Director
|
|
February 7, 2019
|
Huda Y. Zoghbi, M.D.
|
|
|
|
|
|
|
Page Numbers
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
1,467.7
|
|
|
$
|
812.7
|
|
Marketable securities
|
1,342.2
|
|
|
596.8
|
|
||
Accounts receivable - trade, net
|
1,723.7
|
|
|
1,538.6
|
|
||
Accounts receivable from Sanofi
|
226.4
|
|
|
193.7
|
|
||
Accounts receivable from Bayer
|
293.1
|
|
|
242.0
|
|
||
Inventories
|
1,151.2
|
|
|
726.1
|
|
||
Prepaid expenses and other current assets
|
243.3
|
|
|
225.1
|
|
||
Total current assets
|
6,447.6
|
|
|
4,335.0
|
|
||
|
|
|
|
||||
Marketable securities
|
1,755.0
|
|
|
1,486.5
|
|
||
Property, plant, and equipment, net
|
2,575.8
|
|
|
2,358.6
|
|
||
Deferred tax assets
|
828.7
|
|
|
506.3
|
|
||
Other noncurrent assets
|
127.4
|
|
|
77.9
|
|
||
Total assets
|
$
|
11,734.5
|
|
|
$
|
8,764.3
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
218.2
|
|
|
$
|
178.2
|
|
Accrued expenses and other current liabilities
|
772.1
|
|
|
637.2
|
|
||
Deferred revenue from Sanofi
|
246.7
|
|
|
177.7
|
|
||
Deferred revenue - other
|
205.8
|
|
|
142.4
|
|
||
Total current liabilities
|
1,442.8
|
|
|
1,135.5
|
|
||
|
|
|
|
||||
Capital and facility lease obligations
|
708.5
|
|
|
703.5
|
|
||
Deferred revenue from Sanofi
|
279.3
|
|
|
379.9
|
|
||
Deferred revenue - other
|
184.9
|
|
|
249.3
|
|
||
Other noncurrent liabilities
|
361.7
|
|
|
152.0
|
|
||
Total liabilities
|
2,977.2
|
|
|
2,620.2
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 12)
|
|
|
|
||||
|
|
|
|
||||
Stockholders' equity:
|
|
|
|
||||
Preferred Stock, $.01 par value; 30,0000,000 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 2018 and 2017
|
—
|
|
|
—
|
|
||
Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - 111,084,951 in 2018 and 109,477,222 in 2017
|
0.1
|
|
|
0.1
|
|
||
Additional paid-in capital
|
3,911.6
|
|
|
3,512.9
|
|
||
Retained earnings
|
5,254.3
|
|
|
2,946.7
|
|
||
Accumulated other comprehensive (loss) income
|
(12.3
|
)
|
|
0.6
|
|
||
Treasury Stock, at cost; 3,990,021 shares in 2018 and 3,763,868 shares in 2017
|
(396.4
|
)
|
|
(316.2
|
)
|
||
Total stockholders' equity
|
8,757.3
|
|
|
6,144.1
|
|
||
Total liabilities and stockholders' equity
|
$
|
11,734.5
|
|
|
$
|
8,764.3
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
Statements of Operations
|
|
|
|
|
|
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Net product sales
|
|
$
|
4,106.2
|
|
|
$
|
3,718.5
|
|
|
$
|
3,338.4
|
|
Sanofi collaboration revenue
|
|
1,111.1
|
|
|
877.2
|
|
|
658.7
|
|
|||
Bayer collaboration revenue
|
|
1,076.7
|
|
|
938.1
|
|
|
744.3
|
|
|||
Other revenue
|
|
416.8
|
|
|
338.4
|
|
|
119.0
|
|
|||
|
|
6,710.8
|
|
|
5,872.2
|
|
|
4,860.4
|
|
|||
|
|
|
|
|
|
|
||||||
Expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
2,186.1
|
|
|
2,075.1
|
|
|
2,052.3
|
|
|||
Selling, general, and administrative
|
|
1,556.2
|
|
|
1,320.4
|
|
|
1,177.7
|
|
|||
Cost of goods sold
|
|
180.0
|
|
|
202.5
|
|
|
194.6
|
|
|||
Cost of collaboration and contract manufacturing
|
|
254.1
|
|
|
194.6
|
|
|
105.1
|
|
|||
|
|
4,176.4
|
|
|
3,792.6
|
|
|
3,529.7
|
|
|||
|
|
|
|
|
|
|
||||||
Income from operations
|
|
2,534.4
|
|
|
2,079.6
|
|
|
1,330.7
|
|
|||
|
|
|
|
|
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
||||||
Other income (expense), net
|
|
47.3
|
|
|
24.0
|
|
|
6.3
|
|
|||
Interest expense
|
|
(28.2
|
)
|
|
(25.1
|
)
|
|
(7.2
|
)
|
|||
|
|
19.1
|
|
|
(1.1
|
)
|
|
(0.9
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income before income taxes
|
|
2,553.5
|
|
|
2,078.5
|
|
|
1,329.8
|
|
|||
|
|
|
|
|
|
|
||||||
Income tax expense
|
|
(109.1
|
)
|
|
(880.0
|
)
|
|
(434.3
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
$
|
895.5
|
|
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
22.65
|
|
|
$
|
11.27
|
|
|
$
|
8.55
|
|
Net income per share - diluted
|
|
$
|
21.29
|
|
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
|
107.9
|
|
|
106.3
|
|
|
104.7
|
|
|||
Weighted average shares outstanding - diluted
|
|
114.8
|
|
|
115.9
|
|
|
116.3
|
|
|||
|
|
|
|
|
|
|
||||||
Statements of Comprehensive Income
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
$
|
895.5
|
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
||||||
Unrealized (loss) gain on marketable securities
|
|
(7.0
|
)
|
|
12.7
|
|
|
(21.4
|
)
|
|||
Unrealized gain on cash flow hedges
|
|
0.7
|
|
|
0.8
|
|
|
—
|
|
|||
Comprehensive income
|
|
$
|
2,438.1
|
|
|
$
|
1,212.0
|
|
|
$
|
874.1
|
|
|
|
|
|
|
|
|
||||||
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, 2015
|
|
1.9
|
|
|
—
|
|
|
106.4
|
|
|
$
|
0.1
|
|
|
$
|
3,099.5
|
|
|
$
|
852.7
|
|
|
$
|
8.6
|
|
|
(3.6
|
)
|
|
$
|
(306.1
|
)
|
|
$
|
3,654.8
|
|
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
1.7
|
|
|
—
|
|
|
115.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
115.2
|
|
||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(0.3
|
)
|
|
—
|
|
|
(143.2
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(143.2
|
)
|
||||||
Issuance of Common Stock in connection with conversion of convertible notes
|
|
—
|
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
48.0
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
48.0
|
|
||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16.6
|
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
574.9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
574.9
|
|
||||||
Acquisition of Common Stock in connection with exercise of convertible note hedges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10.1
|
|
|
—
|
|
|
—
|
|
|
(0.2
|
)
|
|
(10.1
|
)
|
|
—
|
|
||||||
Reduction of warrants
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(643.3
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(643.3
|
)
|
||||||
Reduction of equity component of convertible notes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(47.8
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(47.8
|
)
|
||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
895.5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
895.5
|
|
||||||
Other comprehensive loss, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(21.4
|
)
|
|
—
|
|
|
—
|
|
|
(21.4
|
)
|
||||||
Balance, December 31, 2016
|
|
1.9
|
|
|
—
|
|
|
107.9
|
|
|
0.1
|
|
|
3,030.0
|
|
|
1,748.2
|
|
|
(12.8
|
)
|
|
(3.8
|
)
|
|
(316.2
|
)
|
|
4,449.3
|
|
||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
2.3
|
|
|
—
|
|
|
240.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
240.6
|
|
||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(0.8
|
)
|
|
—
|
|
|
(301.7
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(301.7
|
)
|
||||||
Issuance of restricted stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19.4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19.4
|
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
524.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
524.6
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
$
|
895.5
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
148.2
|
|
|
145.5
|
|
|
104.7
|
|
|||
Non-cash compensation expense
|
|
427.4
|
|
|
507.3
|
|
|
559.9
|
|
|||
Other non-cash items, net
|
|
12.1
|
|
|
63.5
|
|
|
45.1
|
|
|||
Deferred taxes
|
|
(140.0
|
)
|
|
318.8
|
|
|
(360.1
|
)
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Increase in Sanofi, Bayer, and trade accounts receivable
|
|
(268.9
|
)
|
|
(362.7
|
)
|
|
(143.8
|
)
|
|||
Increase in inventories
|
|
(387.9
|
)
|
|
(314.2
|
)
|
|
(149.8
|
)
|
|||
(Increase) decrease in prepaid expenses and other assets
|
|
(55.7
|
)
|
|
(113.3
|
)
|
|
36.1
|
|
|||
(Decrease) increase in deferred revenue
|
|
(194.5
|
)
|
|
(113.1
|
)
|
|
244.3
|
|
|||
Increase (decrease) in accounts payable, accrued expenses, and other liabilities
|
|
210.0
|
|
|
(23.2
|
)
|
|
254.0
|
|
|||
Total adjustments
|
|
(249.3
|
)
|
|
108.6
|
|
|
590.4
|
|
|||
Net cash provided by operating activities
|
|
2,195.1
|
|
|
1,307.1
|
|
|
1,485.9
|
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable and other securities
|
|
(1,845.5
|
)
|
|
(1,277.2
|
)
|
|
(809.4
|
)
|
|||
Sales or maturities of marketable securities
|
|
775.6
|
|
|
544.6
|
|
|
274.5
|
|
|||
Capital expenditures
|
|
(383.1
|
)
|
|
(272.6
|
)
|
|
(511.9
|
)
|
|||
Other
|
|
(10.0
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash used in investing activities
|
|
(1,463.0
|
)
|
|
(1,005.2
|
)
|
|
(1,046.8
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||||||
Proceeds in connection with capital and facility lease obligations
|
|
—
|
|
|
57.0
|
|
|
5.1
|
|
|||
Payments in connection with capital and facility lease obligations
|
|
—
|
|
|
(19.9
|
)
|
|
(32.8
|
)
|
|||
Repayments of convertible senior notes
|
|
—
|
|
|
—
|
|
|
(12.9
|
)
|
|||
Payments in connection with reduction of outstanding warrants
|
|
—
|
|
|
—
|
|
|
(643.4
|
)
|
|||
Proceeds from issuance of Common Stock
|
|
114.5
|
|
|
240.2
|
|
|
126.7
|
|
|||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(187.2
|
)
|
|
(301.7
|
)
|
|
(143.2
|
)
|
|||
Repurchases of Common Stock
|
|
(4.4
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash used in financing activities
|
|
(77.1
|
)
|
|
(24.4
|
)
|
|
(700.5
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net increase (decrease) in cash, cash equivalents, and restricted cash
|
|
655.0
|
|
|
277.5
|
|
|
(261.4
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash, cash equivalents, and restricted cash at beginning of period
|
|
825.2
|
|
|
547.7
|
|
|
809.1
|
|
|||
|
|
|
|
|
|
|
||||||
Cash, cash equivalents, and restricted cash at end of period
|
|
$
|
1,480.2
|
|
|
$
|
825.2
|
|
|
$
|
547.7
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest (net of amounts capitalized)
|
|
$
|
22.3
|
|
|
$
|
18.7
|
|
|
$
|
5.5
|
|
Cash paid for income taxes
|
|
$
|
205.6
|
|
|
$
|
754.8
|
|
|
$
|
481.4
|
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
|
|
December 31, 2018
|
||||||||||
Balance Sheet Data
|
|
As Reported
|
|
Adjustments
|
|
Balance Without Adoption of ASC 606
|
||||||
Inventories
|
|
$
|
1,151.2
|
|
|
$
|
17.5
|
|
|
$
|
1,168.7
|
|
Deferred tax assets
|
|
$
|
828.7
|
|
|
$
|
17.5
|
|
|
$
|
846.2
|
|
Total assets
|
|
$
|
11,734.5
|
|
|
$
|
35.0
|
|
|
$
|
11,769.5
|
|
Accrued expenses and other current liabilities
|
|
$
|
772.1
|
|
|
$
|
(1.3
|
)
|
|
$
|
770.8
|
|
Deferred revenue from Sanofi (current)
|
|
$
|
246.7
|
|
|
$
|
(93.0
|
)
|
|
$
|
153.7
|
|
Deferred revenue - other (current)
|
|
$
|
205.8
|
|
|
$
|
(58.3
|
)
|
|
$
|
147.5
|
|
Total current liabilities
|
|
$
|
1,442.8
|
|
|
$
|
(152.6
|
)
|
|
$
|
1,290.2
|
|
Deferred revenue from Sanofi (noncurrent)
|
|
$
|
279.3
|
|
|
$
|
163.2
|
|
|
$
|
442.5
|
|
Deferred revenue - other (noncurrent)
|
|
$
|
184.9
|
|
|
$
|
21.8
|
|
|
$
|
206.7
|
|
Total liabilities
|
|
$
|
2,977.2
|
|
|
$
|
32.4
|
|
|
$
|
3,009.6
|
|
Retained earnings
|
|
$
|
5,254.3
|
|
|
$
|
2.6
|
|
|
$
|
5,256.9
|
|
Total stockholders' equity
|
|
$
|
8,757.3
|
|
|
$
|
2.6
|
|
|
$
|
8,759.9
|
|
Total liabilities and stockholders' equity
|
|
$
|
11,734.5
|
|
|
$
|
35.0
|
|
|
$
|
11,769.5
|
|
|
|
Year Ended
December 31, 2018
|
||||||||||
Consolidated Statement of Operations Data
|
|
As Reported
|
|
Adjustments
|
|
Balance Without Adoption of ASC 606
|
||||||
Sanofi collaboration revenue
|
|
$
|
1,111.1
|
|
|
$
|
(163.8
|
)
|
|
$
|
947.3
|
|
Other revenue
|
|
$
|
416.8
|
|
|
$
|
(31.7
|
)
|
|
$
|
385.1
|
|
Total revenues
|
|
$
|
6,710.8
|
|
|
$
|
(195.5
|
)
|
|
$
|
6,515.3
|
|
Cost of collaboration and contract manufacturing
|
|
$
|
254.1
|
|
|
$
|
(17.5
|
)
|
|
$
|
236.6
|
|
Income from operations
|
|
$
|
2,534.4
|
|
|
$
|
(178.0
|
)
|
|
$
|
2,356.4
|
|
Income before income taxes
|
|
$
|
2,553.5
|
|
|
$
|
(178.0
|
)
|
|
$
|
2,375.5
|
|
Income tax expense
|
|
$
|
(109.1
|
)
|
|
$
|
37.2
|
|
|
$
|
(71.9
|
)
|
Net income
|
|
$
|
2,444.4
|
|
|
$
|
(140.8
|
)
|
|
$
|
2,303.6
|
|
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
|
|
2018
|
|
2017
|
|
2016
|
||||||
EYLEA
|
|
$
|
4,076.7
|
|
|
$
|
3,701.9
|
|
|
$
|
3,323.1
|
|
Libtayo
|
|
14.8
|
|
|
—
|
|
|
—
|
|
|||
ARCALYST
|
|
14.7
|
|
|
16.6
|
|
|
15.3
|
|
|||
|
|
$
|
4,106.2
|
|
|
$
|
3,718.5
|
|
|
$
|
3,338.4
|
|
|
Rebates, Chargebacks, and Discounts
|
|
Distribution-
Related
Fees
|
|
Other Sales-
Related
Deductions
|
|
Total
|
||||||||
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
|
|
||||
Provisions
|
223.4
|
|
|
211.0
|
|
|
44.5
|
|
|
478.9
|
|
||||
Credits/payments
|
(212.2
|
)
|
|
(203.1
|
)
|
|
(57.5
|
)
|
|
(472.8
|
)
|
||||
Balance as of December 31, 2018
|
$
|
41.1
|
|
|
$
|
42.0
|
|
|
$
|
8.3
|
|
|
$
|
91.4
|
|
|
|
Year Ended December 31,
|
||||||||||
Sanofi Collaboration Revenue
|
|
2018
|
|
2017
|
|
2016
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
265.3
|
|
|
$
|
508.4
|
|
|
$
|
564.9
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
417.2
|
|
|
368.8
|
|
|
305.9
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(227.0
|
)
|
|
(442.6
|
)
|
|
(459.0
|
)
|
|||
Other
|
|
103.5
|
|
|
119.1
|
|
|
28.4
|
|
|||
Total Antibody
|
|
559.0
|
|
|
553.7
|
|
|
440.2
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
311.8
|
|
|
240.0
|
|
|
138.5
|
|
|||
Reimbursement of Regeneron commercialization-related expenses
|
|
8.9
|
|
|
7.0
|
|
|
—
|
|
|||
Other
|
|
231.4
|
|
|
76.5
|
|
|
80.0
|
|
|||
Total Immuno-oncology
|
|
552.1
|
|
|
323.5
|
|
|
218.5
|
|
|||
|
|
$
|
1,111.1
|
|
|
$
|
877.2
|
|
|
$
|
658.7
|
|
|
|
As of December 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Accounts receivable
|
|
$
|
138.2
|
|
|
$
|
121.0
|
|
Deferred revenue
|
|
$
|
236.1
|
|
|
$
|
117.7
|
|
|
|
Year Ended
December 31, 2018
|
||
Increase due to shipments of commercial supplies to Sanofi
|
|
$
|
251.6
|
|
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(133.2
|
)
|
|
|
As of December 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Accounts receivable
|
|
$
|
77.9
|
|
|
$
|
59.3
|
|
Deferred revenue
|
|
$
|
289.9
|
|
|
$
|
440.0
|
|
|
|
Year Ended
December 31, 2018 |
||
Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606
|
|
$
|
93.6
|
|
Net decrease as a result of cumulative catch-up adjustments arising from changes in the estimate of the stage of completion
|
|
$
|
(135.0
|
)
|
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(108.7
|
)
|
|
|
Year Ended December 31,
|
||||||||||
Bayer EYLEA Collaboration Revenue
|
|
2018
|
|
2017
|
|
2016
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
992.3
|
|
|
$
|
802.3
|
|
|
$
|
649.2
|
|
Reimbursement of Regeneron EYLEA development expenses
|
|
11.2
|
|
|
13.3
|
|
|
9.0
|
|
|||
Other
|
|
73.6
|
|
|
58.7
|
|
|
52.6
|
|
|||
|
|
$
|
1,077.1
|
|
|
$
|
874.3
|
|
|
$
|
710.8
|
|
|
|
As of December 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Accounts receivable (recorded within Prepaid expenses and other current assets)
|
|
$
|
28.8
|
|
|
$
|
71.3
|
|
Deferred revenue
|
|
$
|
194.5
|
|
|
$
|
197.4
|
|
|
|
Year Ended
December 31, 2018 |
||
Increase as a result of cumulative-effect adjustment arising from the adoption of ASC 606
|
|
$
|
48.2
|
|
Increase due to amounts invoiced, excluding amounts recognized as revenue during the period
|
|
$
|
30.7
|
|
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(83.8
|
)
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
As of December 31, 2018
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Available-for-sale debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
$
|
2,734.8
|
|
|
$
|
1.0
|
|
|
$
|
(17.4
|
)
|
|
$
|
2,718.4
|
|
U.S. government and government agency obligations
|
|
110.4
|
|
|
—
|
|
|
(1.0
|
)
|
|
109.4
|
|
||||
Sovereign bonds
|
|
7.6
|
|
|
—
|
|
|
—
|
|
|
7.6
|
|
||||
Commercial paper
|
|
113.8
|
|
|
—
|
|
|
—
|
|
|
113.8
|
|
||||
Certificates of deposit
|
|
60.0
|
|
|
—
|
|
|
—
|
|
|
60.0
|
|
||||
|
|
$
|
3,026.6
|
|
|
$
|
1.0
|
|
|
$
|
(18.4
|
)
|
|
$
|
3,009.2
|
|
As of December 31, 2017
|
|
|
|
|
|
|
|
|
||||||||
Available-for-sale debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
$
|
1,718.0
|
|
|
$
|
2.2
|
|
|
$
|
(7.7
|
)
|
|
$
|
1,712.5
|
|
U.S. government and government agency obligations
|
|
186.7
|
|
|
—
|
|
|
(1.2
|
)
|
|
185.5
|
|
||||
Municipal and sovereign bonds
|
|
4.6
|
|
|
—
|
|
|
—
|
|
|
4.6
|
|
||||
Commercial paper
|
|
107.0
|
|
|
—
|
|
|
—
|
|
|
107.0
|
|
||||
Certificates of deposit
|
|
11.0
|
|
|
—
|
|
|
—
|
|
|
11.0
|
|
||||
|
|
$
|
2,027.3
|
|
|
$
|
2.2
|
|
|
$
|
(8.9
|
)
|
|
$
|
2,020.6
|
|
|
|
As of December 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Maturities within one year
|
|
$
|
1,342.2
|
|
|
$
|
593.8
|
|
Maturities after one year through five years
|
|
1,667.0
|
|
|
1,426.8
|
|
||
|
|
$
|
3,009.2
|
|
|
$
|
2,020.6
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
As of December 31, 2018
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
$
|
1,482.6
|
|
|
$
|
(6.1
|
)
|
|
$
|
801.6
|
|
|
$
|
(11.3
|
)
|
|
$
|
2,284.2
|
|
|
$
|
(17.4
|
)
|
U.S. government and government agency obligations
|
—
|
|
|
—
|
|
|
99.1
|
|
|
(1.0
|
)
|
|
99.1
|
|
|
(1.0
|
)
|
||||||
|
$
|
1,482.6
|
|
|
$
|
(6.1
|
)
|
|
$
|
900.7
|
|
|
$
|
(12.3
|
)
|
|
$
|
2,383.3
|
|
|
$
|
(18.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
As of December 31, 2017
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Corporate bonds
|
$
|
931.0
|
|
|
$
|
(4.9
|
)
|
|
$
|
256.8
|
|
|
$
|
(2.8
|
)
|
|
$
|
1,187.8
|
|
|
$
|
(7.7
|
)
|
U.S. government and government agency obligations
|
110.5
|
|
|
(0.4
|
)
|
|
67.9
|
|
|
(0.8
|
)
|
|
178.4
|
|
|
(1.2
|
)
|
||||||
|
$
|
1,041.5
|
|
|
$
|
(5.3
|
)
|
|
$
|
324.7
|
|
|
$
|
(3.6
|
)
|
|
$
|
1,366.2
|
|
|
$
|
(8.9
|
)
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||
As of December 31, 2018
|
Fair Value
|
|
Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
||||||
Available-for-sale debt securities:
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
2,718.4
|
|
|
—
|
|
|
$
|
2,718.4
|
|
|
U.S. government and government agency obligations
|
109.4
|
|
|
—
|
|
|
109.4
|
|
|||
Sovereign bonds
|
7.6
|
|
|
—
|
|
|
7.6
|
|
|||
Commercial paper
|
113.8
|
|
|
—
|
|
|
113.8
|
|
|||
Certificates of deposit
|
60.0
|
|
|
—
|
|
|
60.0
|
|
|||
Equity securities (unrestricted)
|
43.6
|
|
|
$
|
43.6
|
|
|
—
|
|
||
Equity securities (restricted)
|
44.4
|
|
|
—
|
|
|
44.4
|
|
|||
|
$
|
3,097.2
|
|
|
$
|
43.6
|
|
|
$
|
3,053.6
|
|
|
|
|
|
|
|
||||||
As of December 31, 2017
|
|
|
|
|
|
||||||
Available-for-sale debt securities:
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
1,712.5
|
|
|
—
|
|
|
$
|
1,712.5
|
|
|
U.S. government and government agency obligations
|
185.5
|
|
|
—
|
|
|
185.5
|
|
|||
Municipal and sovereign bonds
|
4.6
|
|
|
—
|
|
|
4.6
|
|
|||
Commercial paper
|
107.0
|
|
|
—
|
|
|
107.0
|
|
|||
Certificates of deposit
|
11.0
|
|
|
—
|
|
|
11.0
|
|
|||
Equity securities (unrestricted)
|
62.7
|
|
|
$
|
62.7
|
|
|
—
|
|
||
|
$
|
2,083.3
|
|
|
$
|
62.7
|
|
|
$
|
2,020.6
|
|
|
As of December 31,
|
||||||
|
2018
|
|
2017
|
||||
Interest rate swap contracts
|
$
|
75.0
|
|
|
$
|
75.0
|
|
Interest rate cap contracts
|
$
|
75.0
|
|
|
$
|
75.0
|
|
|
As of December 31,
|
||||||
|
2018
|
|
2017
|
||||
Land
|
$
|
199.0
|
|
|
$
|
192.8
|
|
Building and improvements
|
1,507.2
|
|
|
1,441.6
|
|
||
Leasehold improvements
|
97.0
|
|
|
102.6
|
|
||
Construction-in-progress
|
469.6
|
|
|
408.9
|
|
||
Laboratory and other equipment
|
773.7
|
|
|
599.1
|
|
||
Furniture, computer and office equipment, and other
|
258.0
|
|
|
179.9
|
|
||
|
3,304.5
|
|
|
2,924.9
|
|
||
Less, accumulated depreciation and amortization
|
(728.7
|
)
|
|
(566.3
|
)
|
||
|
$
|
2,575.8
|
|
|
$
|
2,358.6
|
|
|
As of December 31,
|
||||||
|
2018
|
|
2017
|
||||
Accrued payroll and related costs
|
$
|
261.8
|
|
|
$
|
191.8
|
|
Accrued clinical trial expense
|
142.2
|
|
|
120.9
|
|
||
Accrued sales-related charges, deductions, and royalties
|
182.7
|
|
|
194.5
|
|
||
Income taxes payable
|
20.8
|
|
|
0.2
|
|
||
Other accrued expenses and liabilities
|
164.6
|
|
|
129.8
|
|
||
|
$
|
772.1
|
|
|
$
|
637.2
|
|
|
As of December 31,
|
||||||
|
2018
|
|
2017
|
||||
Current portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
246.7
|
|
|
$
|
177.7
|
|
Received or receivable from Bayer (see Note 3b)
|
44.4
|
|
|
39.0
|
|
||
Received or receivable from Teva (see Note 3c)
|
92.5
|
|
|
43.5
|
|
||
Other
|
68.9
|
|
|
59.9
|
|
||
|
$
|
452.5
|
|
|
$
|
320.1
|
|
Long-term portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
279.3
|
|
|
$
|
379.9
|
|
Received or receivable from Bayer (see Note 3b)
|
45.1
|
|
|
29.7
|
|
||
Received or receivable from Teva (see Note 3c)
|
102.0
|
|
|
153.9
|
|
||
Other
|
37.8
|
|
|
65.7
|
|
||
|
$
|
464.2
|
|
|
$
|
629.2
|
|
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2019
|
|
$
|
4.2
|
|
|
$
|
6.2
|
|
|
$
|
10.4
|
|
2020
|
|
3.6
|
|
|
0.2
|
|
|
3.8
|
|
|||
2021
|
|
3.3
|
|
|
0.1
|
|
|
3.4
|
|
|||
2022
|
|
2.2
|
|
|
—
|
|
|
2.2
|
|
|||
2023
|
|
1.5
|
|
|
—
|
|
|
1.5
|
|
|||
Thereafter
|
|
4.1
|
|
|
—
|
|
|
4.1
|
|
|||
|
|
$
|
18.9
|
|
|
$
|
6.5
|
|
|
$
|
25.4
|
|
Year Ended December 31,
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2018
|
|
$
|
3.7
|
|
|
$
|
1.2
|
|
|
$
|
4.9
|
|
2017
|
|
$
|
3.1
|
|
|
$
|
1.2
|
|
|
$
|
4.3
|
|
2016
|
|
$
|
15.9
|
|
|
$
|
0.9
|
|
|
$
|
16.8
|
|
|
|
Capital and Facility
Lease Obligations
|
||
2019
|
|
$
|
26.4
|
|
2020
|
|
28.4
|
|
|
2021
|
|
27.9
|
|
|
2022
|
|
7.0
|
|
|
2023
|
|
—
|
|
|
Thereafter
|
|
—
|
|
|
|
|
$
|
89.7
|
|
a.
|
Stock Options
|
|
|
Number of Shares
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term (in years)
|
|
Intrinsic Value
|
||||||
Outstanding as of December 31, 2017
|
|
26,205,373
|
|
|
$
|
295.98
|
|
|
|
|
|
|
||
2018:
|
Granted
|
|
4,665,320
|
|
|
$
|
378.51
|
|
|
|
|
|
||
|
Forfeited
|
|
(668,550
|
)
|
|
$
|
422.56
|
|
|
|
|
|
||
|
Expired
|
|
(205,030
|
)
|
|
$
|
467.40
|
|
|
|
|
|
||
|
Exercised
|
|
(1,717,417
|
)
|
|
$
|
66.87
|
|
|
|
|
|
||
Outstanding as of December 31, 2018
|
|
28,279,696
|
|
|
$
|
319.28
|
|
|
6.43
|
|
$
|
2,290.5
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vested and expected to vest as of December 31, 2018
|
|
27,192,461
|
|
|
$
|
316.51
|
|
|
6.32
|
|
$
|
2,289.1
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable as of December 31, 2018
|
|
17,893,976
|
|
|
$
|
275.10
|
|
|
4.98
|
|
$
|
2,276.2
|
|
|
|
Number of Options Granted
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Fair Value
|
|||||
2018:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
4,665,320
|
|
|
$
|
378.51
|
|
|
$
|
114.39
|
|
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
|
|
|
|
2018
|
|
2017
|
|
2016
|
|||
Expected volatility
|
|
29
|
%
|
|
31
|
%
|
|
34
|
%
|
Expected lives from grant date
|
|
4.9 years
|
|
|
5.1 years
|
|
|
5.1 years
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk-free interest rate
|
|
2.69
|
%
|
|
2.16
|
%
|
|
1.84
|
%
|
b.
|
Restricted Stock Awards and Restricted Stock Units
|
|
|
Number of Shares/Units
|
|
Weighted-Average Grant Date Fair Value
|
||||
Balance as of December 31, 2017
|
|
106,260
|
|
|
$
|
404.72
|
|
|
2018:
|
Granted
|
|
380,980
|
|
|
$
|
381.21
|
|
|
Vested
|
|
(6,090
|
)
|
|
$
|
276.46
|
|
|
Forfeited/Cancelled
|
|
(8,520
|
)
|
|
$
|
478.19
|
|
Balance as of December 31, 2018
|
|
472,630
|
|
|
$
|
386.10
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
United States
|
$
|
2,151.7
|
|
|
$
|
1,964.7
|
|
|
$
|
1,650.9
|
|
|
Foreign
|
401.8
|
|
|
113.8
|
|
|
(321.1
|
)
|
||||
|
|
$
|
2,553.5
|
|
|
$
|
2,078.5
|
|
|
$
|
1,329.8
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
Current:
|
|
|
|
|
|
|||||||
|
Federal
|
$
|
223.7
|
|
|
$
|
560.3
|
|
|
$
|
787.0
|
|
|
State
|
4.8
|
|
|
(4.1
|
)
|
|
8.8
|
|
|||
|
Foreign
|
20.6
|
|
|
4.8
|
|
|
(1.4
|
)
|
|||
|
Total current tax expense
|
249.1
|
|
|
561.0
|
|
|
794.4
|
|
|||
Deferred:
|
|
|
|
|
|
|||||||
|
Federal
|
687.6
|
|
|
317.1
|
|
|
(377.4
|
)
|
|||
|
State
|
(1.9
|
)
|
|
(1.3
|
)
|
|
13.4
|
|
|||
|
Foreign
|
(825.7
|
)
|
|
3.2
|
|
|
3.9
|
|
|||
|
Total deferred tax (benefit) expense
|
(140.0
|
)
|
|
319.0
|
|
|
(360.1
|
)
|
|||
|
$
|
109.1
|
|
|
$
|
880.0
|
|
|
$
|
434.3
|
|
|
Year Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
U.S. federal statutory tax rate
|
21.0
|
%
|
|
35.0
|
%
|
|
35.0
|
%
|
Impact of change in U.S. corporate tax rate (the Act)
|
(2.7
|
)
|
|
15.7
|
|
|
—
|
|
Sale of non-inventory related assets between foreign subsidiaries
|
(6.3
|
)
|
|
—
|
|
|
—
|
|
Stock-based compensation
|
(2.5
|
)
|
|
(9.0
|
)
|
|
(10.9
|
)
|
Taxation of non-U.S. operations
|
(1.9
|
)
|
|
0.7
|
|
|
8.8
|
|
Income tax credits
|
(2.6
|
)
|
|
(1.3
|
)
|
|
(1.2
|
)
|
Non-deductible Branded Prescription Drug Fee
|
0.6
|
|
|
1.7
|
|
|
1.9
|
|
Foreign-derived intangible income deduction
|
(1.0
|
)
|
|
—
|
|
|
—
|
|
Domestic production activities deduction
|
—
|
|
|
(2.6
|
)
|
|
(2.8
|
)
|
State and local income taxes
|
0.1
|
|
|
0.1
|
|
|
1.3
|
|
Other permanent differences
|
(0.4
|
)
|
|
2.0
|
|
|
0.6
|
|
Effective income tax rate
|
4.3
|
%
|
|
42.3
|
%
|
|
32.7
|
%
|
|
|
As of December 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Deferred compensation
|
|
$
|
458.2
|
|
|
$
|
391.0
|
|
Fixed assets and intangible assets
|
|
107.8
|
|
|
—
|
|
||
Deferred revenue
|
|
20.2
|
|
|
102.4
|
|
||
Accrued expenses
|
|
53.3
|
|
|
38.3
|
|
||
Other
|
|
33.3
|
|
|
26.5
|
|
||
|
|
672.8
|
|
|
558.2
|
|
||
Valuation allowance
|
|
—
|
|
|
(4.2
|
)
|
||
Total deferred tax assets
|
|
672.8
|
|
|
554.0
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
||||
Fixed assets and intangible assets
|
|
—
|
|
|
(44.6
|
)
|
||
Other
|
|
(2.7
|
)
|
|
(3.1
|
)
|
||
Total deferred tax liabilities
|
|
(2.7
|
)
|
|
(47.7
|
)
|
||
Net deferred tax assets
|
|
$
|
670.1
|
|
|
$
|
506.3
|
|
|
|
2018
|
|
2017
|
|
2016
|
||||||
Balance as of January 1
|
|
$
|
146.2
|
|
|
$
|
117.2
|
|
|
$
|
116.6
|
|
Gross increases related to current year tax positions
|
|
51.4
|
|
|
49.0
|
|
|
45.6
|
|
|||
Gross increases (decreases) related to prior year tax positions
|
|
5.6
|
|
|
(5.6
|
)
|
|
(42.3
|
)
|
|||
Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation
|
|
(13.7
|
)
|
|
(14.4
|
)
|
|
(2.7
|
)
|
|||
Balance as of December 31
|
|
$
|
189.5
|
|
|
$
|
146.2
|
|
|
$
|
117.2
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
Net income - basic
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
$
|
895.5
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Convertible senior notes - interest expense and amortization of discount and note issuance costs
|
|
—
|
|
|
—
|
|
|
0.4
|
|
|||
Net income - diluted
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
$
|
895.9
|
|
|
|
|
|
|
|
|
||||||
(Shares in millions)
|
|
|
|
|
|
|
||||||
Weighted average shares - basic
|
|
107.9
|
|
|
106.3
|
|
|
104.7
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
6.9
|
|
|
9.1
|
|
|
10.2
|
|
|||
Restricted stock
|
|
—
|
|
|
0.5
|
|
|
0.5
|
|
|||
Warrants
|
|
—
|
|
|
—
|
|
|
0.9
|
|
|||
Dilutive potential shares
|
|
6.9
|
|
|
9.6
|
|
|
11.6
|
|
|||
Weighted average shares - diluted
|
|
114.8
|
|
|
115.9
|
|
|
116.3
|
|
|||
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
22.65
|
|
|
$
|
11.27
|
|
|
$
|
8.55
|
|
Net income per share - diluted
|
|
$
|
21.29
|
|
|
$
|
10.34
|
|
|
$
|
7.70
|
|
|
|
Year Ended December 31,
|
|||||||
(Shares in millions)
|
|
2018
|
|
2017
|
|
2016
|
|||
Stock options
|
|
14.9
|
|
|
9.2
|
|
|
8.0
|
|
|
|
December 31,
|
|
December 31,
|
|
December 31,
|
||||||
|
|
2018
|
|
2017
|
|
2016
|
||||||
Cash and cash equivalents
|
|
$
|
1,467.7
|
|
|
$
|
812.7
|
|
|
$
|
535.2
|
|
Restricted cash included in Other noncurrent assets
|
|
12.5
|
|
|
12.5
|
|
|
12.5
|
|
|||
Total cash, cash equivalents, and restricted cash shown in the Consolidated Statement of Cash Flows
|
|
$
|
1,480.2
|
|
|
$
|
825.2
|
|
|
$
|
547.7
|
|
|
|
|
|
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-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 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.
|
Shares
|
|
|
Full Vest Date
|
|
[
|
]*
|
|
[ ]*
|
|
|
|
You and the Company agree that this award is 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 Restricted Stock Agreement, both of which are attached and made a part of this document.
|
|
|
|
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
ID:
[
]
|
|
Notice of Grant of Stock Options
|
777 Old Saw Mill River Road
|
|
and Option Agreement
|
Tarrytown, New York 10591
|
|
|
|
|
|
||
|
||
[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.
|
|
*
|
|
The next Annual Meeting of Shareholders following the Grant Date.
|
|
|
|||
**
|
|
First anniversary of the Grant Date.
|
|
|
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
ID:
[
]
|
|
Notice of Grant of Restricted Stock Units
|
777 Old Saw Mill River Road
|
|
and Restricted Stock Agreement
|
Tarrytown, New York 10591
|
|
|
|
|
|
||
|
||
[NAME]
|
RSU Number:
|
[
]
|
[ADDRESS]
|
Plan:
|
[
]
|
|
ID:
|
[
]
|
|
|
|
You and the Company agree that these restricted stock units 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 Restricted Stock Unit Agreement, both of which are attached and made a part of this document.
|
|
*
|
|
The next Annual Meeting of Shareholders following the Grant Date.
|
|
|
|
**
|
|
First anniversary of the Grant Date.
|
(A)
|
Sanofi shall not have a surviving obligation under the Original Agreement with respect to Terminated IO Discovery Program Costs incurred by Regeneron under the Terminated IO Discovery Program from October 1, 2018 through December 31, 2018, which costs shall be reimbursed in accordance with Section 4.1;
|
(B)
|
the licenses granted to Sanofi under the Original Agreement (other than in Section 2.8 thereof) are hereby terminated as of the A&R Agreement Effective Date and the licenses granted by Sanofi under Section 2.7 of the Original Agreement are revised to read as set forth in Section 2.6 of this Agreement;
|
(C)
|
Sanofi hereby grants to Regeneron a non-exclusive, fully paid-up (other than with respect to IO Royalty Products), non-transferable, royalty-free (other than with respect to IO Royalty Products), worldwide, license, with the right to sublicense, under the “Sanofi Target IP” (as such term is defined in the Original Agreement) that was “Sanofi Target
|
(D)
|
the period for the survival of obligations with respect to Confidential Information (as defined in the Original Agreement) under Article 9 of the Original Agreement that relates only to the Terminated IO Discovery Program shall end five (5) years after the A&R Agreement Effective Date and the period for the survival of such obligations with respect to other Confidential Information (as defined in the Original Agreement) under Article 9 of the Original Agreement shall end five (5) years after the termination or expiration of this Agreement;
|
(E)
|
to the extent a Receiving Party (as defined in the Original Agreement) is in possession of Confidential Information (as defined in the Original Agreement) of a Disclosing Party (as defined in the Original Agreement) that is no longer relevant to the Receiving Party’s rights or obligations under this Agreement, the Receiving Party shall return or, at the Disclosing Party’s request, destroy all documents or other tangible materials representing such Confidential Information as provided in Section 12.8 of the Original Agreement; provided, that one (1) copy may be maintained in the confidential files of the Receiving Party for the purpose of complying with the terms of the Original Agreement;
|
(F)
|
the following Sections of the Original Agreement shall not survive such termination: Section 4.2(e), Section 12.7(c) (for clarity, Regeneron shall not have any royalty obligations under Article 4 of the Original Agreement with respect to any IO Royalty Product (as defined in the Original Agreement) which shall instead be subject to Article 4 of this Agreement), and Section 12.10;
|
(G)
|
for clarity, Article 10 of the Original Agreement will survive with respect to matters other than those with respect to IO Discovery Program Antibodies or IO Discovery Program Target Profiles, which will remain subject to Article 10 of this Agreement; and
|
(H)
|
in light of the Confidential Information disclosed under the Original Agreement, including the written reports
|
•
|
A bi-specific Antibody that targets solely BCMA and CD3
|
•
|
A bi-specific Antibody that targets solely MUC16 and CD3
|
REGN3767 (an IO Antibody that targets solely LAG3)
|
REGN4659 (an IO Antibody that targets solely CTLA-4)
|
•
|
Sanofi will pay Regeneron $462 million representing the balance of payments due under the original Immuno-oncology Agreement, which covers the Sanofi share of the immuno-oncology discovery program costs for the last quarter of 2018 and up to $120 million in development costs for the two selected clinical-stage bispecific antibodies, plus the termination fee for the other programs under the original immuno-oncology agreement.
|
•
|
Sanofi secures the right to opt-in to the BCMAxCD3 and MUC16xCD3 bispecific programs when proof of concept is achieved or when the allocated funding is expended.
|
•
|
Regeneron will commit up to $70 million to further develop the BCMAxCD3 bispecific antibody for multiple myeloma and up to $50 million to further develop the MUC16xCD3 bispecific for mucin-16 expressing cancers.
|
•
|
Post opt-in, Sanofi will lead development and commercialization of the BCMAxCD3 bispecific and fund 100 percent of development costs, with Regeneron reimbursing up to 50 percent out of its share of collaboration profits. Sanofi and Regeneron will share global profits equally.
|
•
|
Post opt-in, Regeneron will lead MUC16xCD3 bispecific development and lead commercialization in the U.S. The companies will share development costs and global profits equally. Sanofi will lead commercialization outside the U.S.
|
•
|
The companies’ ongoing collaboration for the development and commercialization of Libtayo
®
(cemiplimab-rwlc), a PD-1 antibody, is unaffected by the amended Discovery and Development Agreement.
|
•
|
Regeneron retains full rights to its other immuno-oncology programs.
|
•
|
Lung problems (pneumonitis).
Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
|
•
|
Intestinal problems (colitis) that can lead to tears or holes in your intestine.
Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
|
•
|
Liver problems (hepatitis).
Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
|
•
|
Hormone gland problems
(especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
|
•
|
Kidney problems,
including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
|
•
|
Skin problems.
Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
|
•
|
Problems in other organs.
Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph
|
•
|
Rejection of a transplanted organ.
Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
|
•
|
Infusion (IV) reactions that
can sometimes be severe and life-threatening.
Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.
|
•
|
Your healthcare provider will give you a pregnancy test before you start treatment.
|
•
|
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
|
•
|
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
|
•
|
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
|
Media Relations
Hala Mirza
Tel: +1 (914) 847-3422
hala.mirza@regeneron.com
|
Investor Relations
Mark Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
|
|
Name of Subsidiary*
|
|
State or Other Jurisdiction of Incorporation or Organization
|
|
Loop Road Holdings LLC
|
|
New York
|
|
Old Saw Mill Holdings LLC
|
|
New York
|
|
OSMR Holdings
|
|
Bermuda
|
|
OSMR International
|
|
Bermuda
|
|
OSMR LLC
|
|
New York
|
|
Regeneron Assurance, Inc.
|
|
New York
|
|
Regeneron Atlantic Holdings
|
|
Bermuda
|
|
Regeneron Belgium BVBA
|
|
Belgium
|
|
Regeneron Capital International B.V.
|
|
The Netherlands
|
|
Regeneron Genetics Center LLC
|
|
Delaware
|
|
Regeneron Healthcare Solutions, Inc.
|
|
New York
|
|
Regeneron International Holdings, LLC
|
|
Delaware
|
|
Regeneron International Limited
|
|
Ireland
|
|
Regeneron Ireland Holdings Unlimited Company
|
|
Ireland
|
|
Regeneron Ireland Unlimited Company
|
|
Ireland
|
|
Regeneron Spain, S.L.U.
|
|
Spain
|
|
Regeneron UK Limited
|
|
United Kingdom
|
|
Rockwood Road Holdings LLC
|
|
New York
|
|
_____________
|
|
|
|
* Directly or indirectly wholly owned by Regeneron Pharmaceuticals, Inc.
|
||
|
|
|
|
1.
|
I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
Date:
|
February 7, 2019
|
/s/ Leonard S. Schleifer
|
|
|
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
President and Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
1.
|
I have reviewed this annual report on Form 10-K of Regeneron Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
Date:
|
February 7, 2019
|
/s/ Robert E. Landry
|
|
|
|
Robert E. Landry
|
|
|
|
Executive Vice President, Finance and Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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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 7, 2019
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/s/ Robert E. Landry
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Robert E. Landry
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Executive Vice President, Finance and Chief Financial Officer
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(Principal Financial Officer)
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February 7, 2019
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