(Mark One)
|
|
|
|
☒
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
||
|
For the fiscal year ended
|
December 31, 2019
|
|
|
OR
|
|
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
||
|
For the transition period from __________ to __________
|
|
Commission File Number:
|
0-19034
|
|
New York
|
|
13-3444607
|
(State or other jurisdiction of incorporation or organization)
|
|
(I.R.S. Employer Identification No.)
|
777 Old Saw Mill River Road
|
Tarrytown,
|
New York
|
10591-6707
|
(Address of principal executive offices, including zip code)
|
Title of each class
|
Trading Symbol
|
Name of each exchange on which registered
|
Common Stock - par value $.001 per share
|
REGN
|
NASDAQ Global Select Market
|
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
|
Yes
|
☒
|
No
|
☐
|
|
|
|
|
|
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
|
Yes
|
☐
|
No
|
☒
|
|
|
|
|
|
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.
|
Yes
|
☒
|
No
|
☐
|
|
|
|
|
|
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).
|
Yes
|
☒
|
No
|
☐
|
|
|
|
|
|
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.
|
Large accelerated filer
|
☒
|
|
Accelerated filer
|
☐
|
|
Non-accelerated filer
|
☐
|
|
Smaller reporting company
|
☐
|
|
Emerging growth company
|
☐
|
|
|
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.
|
☐
|
|
|
|
|
|
|
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
|
Yes
|
☐
|
No
|
☒
|
Class of Common Stock
|
|
Number of Shares
|
Class A Stock, $.001 par value
|
|
1,848,970
|
Common Stock, $.001 par value
|
|
108,170,839
|
DOCUMENTS INCORPORATED BY REFERENCE
|
Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its 2020 Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages 76 to 81 of this filing.
|
|
|
|
|
Page Numbers
|
|
|
|
|
|
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|||
|
|
|
|
|
|
"ARCALYST®", "EYLEA®", "Libtayo®" (in the United States), "Regeneron®", "Regeneron Genetics Center®", "Veloci-Bi®", "VelociGene®", "VelociMab®", "VelocImmune®", "VelociMouse®", "VelociSuite®", "VelociT™", 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.
|
|
|
Year Ended December 31,
|
||||||||||
(In millions, except per share data)
|
|
2019
|
|
2018
|
|
2017
|
||||||
Revenues
|
|
$
|
7,863.4
|
|
|
$
|
6,710.8
|
|
|
$
|
5,872.2
|
|
Net income
|
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
Net income per share - diluted
|
|
$
|
18.46
|
|
|
$
|
21.29
|
|
|
$
|
10.34
|
|
Product
|
|
Disease Area(1)
|
|
Territory
|
||||||
|
|
U.S.
|
|
EU
|
|
Japan
|
|
ROW(6)
|
||
EYLEA (aflibercept) Injection(2)
|
-
|
Neovascular age-related macular degeneration ("wet AMD")
|
|
a
|
|
a
|
|
a
|
|
a
|
-
|
Diabetic macular edema ("DME")
|
|
a
|
|
a
|
|
a
|
|
a
|
|
-
|
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")
|
|
a
|
|
a
|
|
a
|
|
a
|
|
-
|
Myopic choroidal neovascularization ("mCNV")
|
|
|
|
a
|
|
a
|
|
a
|
|
-
|
Diabetic retinopathy
|
|
a
|
|
|
|
|
|
|
|
Dupixent (dupilumab) Injection(3)
|
-
|
Atopic dermatitis (in adults and adolescents)(7)
|
|
a
|
|
a
|
|
a
|
|
a
|
-
|
Asthma (in adults and adolescents)
|
|
a
|
|
a
|
|
a
|
|
a
|
|
-
|
Chronic rhinosinusitis with nasal polyposis ("CRSwNP")
|
|
a
|
|
a
|
|
|
|
a
|
|
Libtayo (cemiplimab) Injection(3)(4)
|
-
|
Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC")
|
|
a
|
|
a
|
|
|
|
a
|
Praluent (alirocumab) Injection(3)
|
-
|
LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") (in adults)
|
|
a
|
|
a
|
|
a
|
|
a
|
-
|
Cardiovascular risk reduction in patients with established cardiovascular disease
|
|
a
|
|
a
|
|
|
|
a
|
|
Kevzara (sarilumab) Solution for Subcutaneous Injection(3)
|
-
|
Rheumatoid arthritis ("RA") (in adults)
|
|
a
|
|
a
|
|
a
|
|
a
|
ARCALYST® (rilonacept) Injection for Subcutaneous Use
|
-
|
Cryopyrin-Associated Periodic Syndromes ("CAPS"), including Familial Cold Auto-inflammatory Syndrome ("FCAS") and Muckle-Wells Syndrome ("MWS")
|
|
a
|
|
|
|
|
|
|
ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion(5)
|
-
|
Metastatic colorectal cancer ("mCRC")
|
|
a
|
|
a
|
|
a
|
|
a
|
|
|
|
|
|
|
|
||||
(1) Refer to label information in each territory for specific indication
|
||||||||||
(2) In collaboration with Bayer (outside the United States)
|
||||||||||
(3) In collaboration with Sanofi
|
||||||||||
(4) Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States
|
||||||||||
(5) 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
|
||||||||||
(6) Rest of world. Checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union (EU), or Japan
|
||||||||||
(7) Approval in Japan is for adults and adolescents 15 years of age and older
|
Clinical Program
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Regulatory Review(i)
|
|
2019 and 2020 Events to Date
|
|
Select Upcoming Milestones
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmology
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
EYLEA
|
|
|
-
|
High-dose formulation in wet AMD
|
-
|
Retinopathy of prematurity
("ROP")(c)
|
|
|
-
|
Approved by FDA for the treatment of diabetic retinopathy
|
-
|
Initiate Phase 3 studies of a high-dose formulation of aflibercept in wet AMD and DME (mid-2020)
|
|
|
|
|
|
|
|
|
|
-
|
Pre-filled syringe approved by FDA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology & Inflammatory Diseases
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Dupixent (dupilumab)(a)
Antibody to IL-4R alpha subunit
|
|
|
-
|
Grass allergy
|
-
|
Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)(d)
|
-
|
Atopic dermatitis in pediatrics (6–11 years of age) (U.S. and EU)(d)
|
-
|
Approved by FDA and European Commission ("EC") for expanded atopic dermatitis indication in adolescent patients (12–17 years of age)
|
-
|
FDA decision (target action date of May 26, 2020) on supplemental Biologics License Application ("sBLA") and EC decision (second half 2020) for expanded atopic dermatitis indication in pediatric patients (6–11 years of age)
|
|
|
-
|
Peanut allergy
|
|
|
|
|
|||||
|
|
|
|
|
-
|
Asthma in pediatrics (6–11 years of age)
|
-
|
CRSwNP (Japan)
|
|
|
||
|
|
|
|
|
-
|
Eosinophilic esophagitis
("EOE")(c) |
-
|
Auto-injector for 300 mg dose (U.S. and Japan)
|
-
|
Reported that Phase 3 study in pediatric patients (6–11 years of age) with severe atopic dermatitis met its primary and secondary endpoints
|
|
|
|
|
|
|
|
-
|
Chronic obstructive pulmonary disease ("COPD")
|
|
|
|
-
|
Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022)
|
|
|
|
|
|
|
-
|
Bullous pemphigoid (Phase 2/3)(c)
|
|
|
-
|
Approved by EC for treatment of asthma in adults and adolescents
|
|
|
|
|
|
|
|
-
|
Chronic spontaneous urticaria
|
|
|
|
-
|
Report results from Phase 3 study for asthma in pediatric patients (6–11 years of age) (second half 2020)
|
|
|
|
|
|
|
-
|
Prurigo nodularis
|
|
|
-
|
Approved by FDA and EC for CRSwNP
|
|
|
|
|
|
|
|
|
|
|
|
-
|
EU approval for 200 mg and 300 mg auto-injector
|
-
|
Japan decision on application for CRSwNP (first half 2020)
|
|
|
|
|
|
|
|
|
|
-
|
FDA issued Complete Response Letter ("CRL") on sBLA for 200 mg auto-injector
|
-
|
FDA decision on application for 300 mg auto-injector (target action date of March 20, 2020)
|
|
|
|
|
|
|
|
|
|
-
|
Completed Phase 2a trial in grass allergy
|
-
|
Resubmit sBLA for 200 mg auto-injector (first half 2020)
|
|
|
|
|
|
|
|
|
|
|
|
-
|
Present results from Phase 2a trial in grass allergy at medical meeting (first half 2020)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Program (continued)
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Regulatory Review(i)
|
|
2019 and 2020 Events to Date
|
|
Select Upcoming Milestones
|
|
|
|
|
|
|
|
|
|
|
|
-
|
Report results from Phase 2 study in peanut allergy (first half 2021)
|
|
|
|
|
|
|
|
|
|
|
|
-
|
Initiate Phase 3 study in pediatric patients with EOE (second half 2020)
|
|
|
|
|
|
|
|
|
|
|
|
-
|
Report results from Phase 2 portion of Phase 2/3 study in EOE (mid-2020)
|
|
|
|
|
|
|
|
|
|
|
|
-
|
Initiate Phase 3 studies in hand and foot atopic dermatitis and allergic bronchopulmonary aspergillosis ("ABPA") (first half 2020)
|
Kevzara (sarilumab)(a)
Antibody to IL-6R
|
|
|
-
|
Polyarticular-course juvenile idiopathic arthritis ("pcJIA")
|
-
|
Polymyalgia rheumatica ("PMR")
|
|
|
|
|
|
|
|
|
-
|
Systemic juvenile idiopathic arthritis ("sJIA")
|
-
|
Giant cell arteritis ("GCA")
|
|
|
|
|
|
|
|
REGN3500(a)
Antibody to IL-33.
Studied as monotherapy and in combination with Dupixent.
|
|
|
-
|
Asthma
|
|
|
|
|
-
|
Reported that Phase 2 study in asthma met its primary and key secondary endpoints
|
-
|
Report results from Phase 2 study in atopic dermatitis (second half 2020)
|
|
|
-
|
COPD
|
|
|
|
|
|
|
|||
|
|
-
|
Atopic dermatitis
|
|
|
|
|
-
|
Sanofi reported that Phase 2 study in COPD demonstrated reduced exacerbations in the overall study population, but results were not statistically significant
|
-
|
Initiate Phase 2b study in asthma (second half 2020)
|
|
REGN1908-1909(f)
Multi-antibody therapy to Feld1
|
|
|
-
|
Cat allergy
|
|
|
|
|
|
|
-
|
Report results from Phase 2 study in cat allergic asthmatics (first half 2020)
|
REGN5713-5714-5715
Antibody to Betv1
|
-
|
Birch allergy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Program (continued)
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Regulatory Review(i)
|
|
2019 and 2020 Events to Date
|
|
Select Upcoming Milestones
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Libtayo (cemiplimab)(a)(h)
Antibody to PD-1
|
-
|
Solid tumors and advanced hematologic malignancies
|
-
|
Basal cell carcinoma ("BCC")
(potentially pivotal study)
|
-
|
First-line non-small cell lung cancer ("NSCLC")
|
|
|
-
|
Conditionally approved by EC for treatment of advanced CSCC
|
-
|
Report results from potentially pivotal Phase 2 study in BCC (mid-2020)
|
|
-
|
Metastatic or locally advanced CSCC(d)
|
-
|
Second-line cervical cancer(e)
|
|
|
-
|
Independent data monitoring committee conducted an interim analysis for overall survival in a Phase 3 NSCLC trial, and recommended trial continue as planned
|
-
|
Report results from Phase 3 study in cervical cancer (first half 2021)
|
||
|
|
|
-
|
Neoadjuvant CSCC
|
-
|
Adjuvant CSCC
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
-
|
Interim analysis of overall survival from Phase 3 NSCLC monotherapy study (2020)
|
|
REGN1979
Bispecific antibody targeting CD20 and CD3
|
-
|
Certain B-cell malignancies(c)
|
-
|
B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study)
|
|
|
|
|
-
|
Reported updated results from Phase 1 trial in B-cell malignancies
|
-
|
Report updated results from initial study in certain B-cell malignancies (2020)
|
|
|
|
|
|
|
|
-
|
Continued to expand potentially pivotal Phase 2 program with different subtypes of NHL
|
-
|
Continue to expand potentially pivotal Phase 2 study (2020)
|
||
REGN5458(a)
Bispecific antibody targeting BCMA and CD3
|
-
|
Multiple myeloma
|
|
|
|
|
|
|
-
|
Reported positive preliminary results from Phase 1 trial in multiple myeloma
|
-
|
Report updated results from initial study in multiple myeloma (2020)
|
REGN5459(a)
Bispecific antibody targeting BCMA and CD3
|
-
|
Multiple myeloma
|
|
|
|
|
|
|
|
|
|
|
REGN4018(a)
Bispecific antibody targeting MUC16 and CD3
|
-
|
Platinum-resistant ovarian cancer
|
|
|
|
|
|
|
|
|
|
|
REGN5678
Bispecific antibody targeting PSMA and CD28
|
-
|
Prostate cancer
|
|
|
|
|
|
|
|
|
|
|
REGN5093
Bispecific antibody targeting two distinct MET epitopes
|
-
|
MET-altered advanced NSCLC
|
|
|
|
|
|
|
|
|
|
|
REGN3767(f)
Antibody to LAG-3
|
-
|
Solid tumors and advanced hematologic malignancies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Program (continued)
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Regulatory Review(i)
|
|
2019 and 2020 Events to Date
|
|
Select Upcoming Milestones
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular/Metabolic Diseases
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Praluent (alirocumab)(a)
Antibody to PCSK9
|
|
|
|
|
-
|
Homozygous familial hypercholesterolemia ("HoFH")(c) in adults and pediatrics
|
|
|
-
|
Approved by EC for a new indication to reduce cardiovascular risk in adults with established ASCVD
|
-
|
Report results from Phase 3 study in HoFH and submit sBLA (2020)
|
|
|
|
|
-
|
HeFH in pediatrics
|
|
|
-
|
Approved by FDA for a new indication to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established CV disease
|
|
|
|
|
|
|
|
|
|
|
-
|
Approved by FDA for treatment of adults with primary hyperlipidemia (including HeFH) to reduce low-density lipoprotein cholesterol ("LDL-C")
|
|
|||
Evinacumab(f) (REGN1500)
Antibody to ANGPTL3
|
|
|
-
|
Refractory hypercholesterolemia (both HeFH and non-FH)
|
-
|
HoFH(c)(d)
|
|
|
-
|
Reported positive top-line results from Phase 3 trial in HoFH
|
-
|
Submit BLA and Marketing Authorization Application ("MAA") for HoFH (2020)
|
|
|
-
|
Severe hypertriglyceridemia
|
|
|
|
|
|
||||
Pozelimab(f) (REGN3918)
Antibody to C5
|
|
|
-
|
Paroxysmal nocturnal hemoglobinuria ("PNH")(c)
|
|
|
|
|
-
|
Reported positive top-line results from Phase 2 trial in PNH
|
-
|
Initiate combination program with Alnylam's cemdisiran (second half 2020)
|
|
|
|
|
|
|
|
|
|
|
-
|
Initiate Phase 3 program in PNH (second half 2020)
|
|
Garetosmab(f) (REGN2477)
Antibody to Activin A
|
|
|
-
|
Fibrodysplasia ossificans progressiva
("FOP")(c)(e) (potentially pivotal study)
|
|
|
|
|
-
|
Reported results from Phase 2 study in FOP
|
-
|
Discuss regulatory submission for FOP with regulatory authorities (first half 2020)
|
REGN4461(f)
Agonist antibody to leptin receptor ("LEPR")
|
|
|
-
|
Generalized lipodystrophy(e)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Program (continued)
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Regulatory Review(i)
|
|
2019 and 2020 Events to Date
|
|
Select Upcoming Milestones
|
Pain
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Fasinumab(b)(f) (REGN475)
Antibody to NGF
|
|
|
|
|
-
|
Osteoarthritis pain of the knee or hip(e)
|
|
|
|
|
-
|
Report results from Phase 3 studies in osteoarthritis pain of the knee or hip (mid-2020)
|
REGN5069
Antibody to GFRα3
|
|
|
-
|
Osteoarthritis pain of the knee(e)
|
|
|
|
|
|
|
-
|
Report results from Phase 2 study in osteoarthritis pain of the knee (second half 2020)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious Diseases
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
REGN-EB3(f)(g) (REGN3470-3471-3479)
Multi-antibody therapy to Ebola virus infection ("Ebola")
|
|
|
|
|
|
|
-
|
Ebola (U.S.)(c)(d)(j)
|
-
|
Investigational trial in the Democratic Republic of Congo was stopped early based on data showing that REGN-EB3 was superior to ZMapp in preventing death
|
-
|
Complete rolling BLA submission for Ebola (first half 2020)
|
Note 1: For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after recruiting for the corresponding study or studies has commenced
|
||||
Note 2: We have discontinued further clinical development of REGN4659, an antibody to CTLA4, which was previously being studied in advanced NSCLC
|
||||
(a) In collaboration with Sanofi
|
||||
(b) In collaboration with Teva and Mitsubishi Tanabe Pharma
|
||||
(c) 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 sales of the product candidate.
|
||||
(g) 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) Information in this column relates to U.S., EU, and Japan regulatory submissions only
|
||||
(j) Included as part of the Extension Phase of a trial coordinated by World Health Organization
|
•
|
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 payors, including Medicare and Medicaid in the United States and other government and private payors in the United States and foreign jurisdictions, as well as U.S. and foreign payor restrictions on eligible patient populations and the reimbursement process (including drug price control measures that may be introduced in the United States by various federal and state authorities);
|
•
|
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 existing and potential new competition for EYLEA (discussed further under "The commercial success of our products and product candidates is subject to significant competition - Marketed Products" below) and the willingness of retinal specialists and patients to start or continue treatment with EYLEA or to switch from another product to EYLEA;
|
•
|
serious complications or side effects in connection with the use of our marketed products, as discussed under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Serious complications or side effects in connection with the use of our products and in clinical trials for our product candidates and new indications for our marketed products could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition" below;
|
•
|
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 Dupixent and Praluent (described further in Note 16 to our Consolidated Financial Statements included in this report), as well as 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 outcome of the pending government investigations described in Note 16 to our Consolidated Financial Statements included in this report;
|
•
|
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 price reporting and other disclosure requirements of such laws and regulations and the potential impact of such requirements on physician prescribing practices and payor coverage.
|
•
|
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 (or the expectation of any such sales);
|
•
|
changes in tax rates, laws, or interpretation of tax laws;
|
•
|
arrivals and departures of key personnel;
|
•
|
general market conditions;
|
•
|
our ability to repurchase our Common Stock under any share repurchase program on favorable terms or at all;
|
•
|
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 9.8% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options held by such persons which are exercisable within 60 days of December 31, 2019, and 20.5% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by such persons which are exercisable within 60 days of December 31, 2019; and
|
•
|
our five largest shareholders (including our largest shareholder Sanofi) plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately 45.2% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of December 31, 2019. In addition, these five shareholders plus our Chief Executive Officer held approximately 51.4% of the combined voting power of our outstanding shares of Common Stock and Class
|
•
|
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."
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
|
12/31/2017
|
|
12/31/2018
|
|
12/31/2019
|
||||||||||||
Regeneron
|
$
|
100.00
|
|
|
$
|
132.33
|
|
|
$
|
89.48
|
|
|
$
|
91.64
|
|
|
$
|
91.04
|
|
|
$
|
91.52
|
|
S&P 500
|
$
|
100.00
|
|
|
$
|
99.27
|
|
|
$
|
108.74
|
|
|
$
|
129.86
|
|
|
$
|
121.76
|
|
|
$
|
156.92
|
|
NQ US Pharma TR Index
|
$
|
100.00
|
|
|
$
|
105.43
|
|
|
$
|
104.29
|
|
|
$
|
125.57
|
|
|
$
|
134.11
|
|
|
$
|
153.57
|
|
Period
|
|
Total Number of Shares Purchased
|
|
Average Price Paid per Share
|
|
Total Number of Shares Purchased as Part of a Publicly Announced Program
|
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Program
|
||||||
11/1/2019–11/30/2019
|
|
509,365
|
|
|
$
|
343.35
|
|
|
508,314
|
|
|
$
|
825,664,565
|
|
12/1/2019–12/31/2019
|
|
214,282
|
|
|
$
|
371.59
|
|
|
214,282
|
|
|
$
|
745,967,321
|
|
Total
|
|
723,647
|
|
(a)
|
|
|
|
722,596
|
|
(a)
|
|
|||
|
|
|
|
|
|
|
|
|
||||||
(a) The difference between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program is related to Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock awards or restricted stock units granted under one of our long-term incentive plans.
|
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)
|
2019
|
|
2018
|
|
2017
|
||||||
Revenues
|
$
|
7,863.4
|
|
|
$
|
6,710.8
|
|
|
$
|
5,872.2
|
|
Operating expenses
|
(5,653.6
|
)
|
|
(4,176.4
|
)
|
|
(3,792.6
|
)
|
|||
Income from operations
|
2,209.8
|
|
|
2,534.4
|
|
|
2,079.6
|
|
|||
Other income (expense), net
|
219.3
|
|
|
19.1
|
|
|
(1.1
|
)
|
|||
Income before income taxes
|
2,429.1
|
|
|
2,553.5
|
|
|
2,078.5
|
|
|||
Income tax expense
|
(313.3
|
)
|
|
(109.1
|
)
|
|
(880.0
|
)
|
|||
Net income
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
|
|
|
|
|
||||||
Net income per share - diluted
|
$
|
18.46
|
|
|
$
|
21.29
|
|
|
$
|
10.34
|
|
|
Year Ended December 31,
|
|
$ Change
|
||||||||||||||||
(In millions)
|
2019
|
|
2018
|
|
2017
|
|
2019 vs. 2018
|
|
2018 vs. 2017
|
||||||||||
Net product sales in the United States:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
EYLEA
|
$
|
4,644.2
|
|
|
$
|
4,076.7
|
|
|
$
|
3,701.9
|
|
|
$
|
567.5
|
|
|
$
|
374.8
|
|
Libtayo
|
175.7
|
|
|
14.8
|
|
|
—
|
|
|
160.9
|
|
|
14.8
|
|
|||||
ARCALYST
|
14.5
|
|
|
14.7
|
|
|
16.6
|
|
|
(0.2
|
)
|
|
(1.9
|
)
|
|||||
Sanofi and Bayer collaboration revenue:
|
|
|
|
|
|
|
|
|
|
||||||||||
Sanofi
|
1,426.8
|
|
|
1,111.1
|
|
|
877.2
|
|
|
315.7
|
|
|
233.9
|
|
|||||
Bayer
|
1,188.8
|
|
|
1,076.7
|
|
|
938.1
|
|
|
112.1
|
|
|
138.6
|
|
|||||
Other revenue
|
413.4
|
|
|
416.8
|
|
|
338.4
|
|
|
(3.4
|
)
|
|
78.4
|
|
|||||
Total revenues
|
$
|
7,863.4
|
|
|
$
|
6,710.8
|
|
|
$
|
5,872.2
|
|
|
$
|
1,152.6
|
|
|
$
|
838.6
|
|
(In millions)
|
Rebates, Chargebacks, and Discounts
|
|
Distribution-
Related Fees |
|
Other Sales-
Related Deductions |
|
Total
|
||||||||
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
|
|
||||
Provisions
|
423.2
|
|
|
242.9
|
|
|
61.8
|
|
|
727.9
|
|
||||
Credits/payments
|
(384.0
|
)
|
|
(238.5
|
)
|
|
(40.7
|
)
|
|
(663.2
|
)
|
||||
Balance as of December 31, 2019
|
$
|
80.3
|
|
|
$
|
46.4
|
|
|
$
|
29.4
|
|
|
$
|
156.1
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2017
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of research and development expenses - Discovery Agreement
|
|
—
|
|
|
—
|
|
|
$
|
130.0
|
|
||
Reimbursement of research and development expenses - License and Collaboration Agreement
|
|
$
|
277.7
|
|
|
$
|
265.3
|
|
|
378.4
|
|
|
Reimbursement of commercialization-related expenses(1)
|
|
479.9
|
|
|
417.2
|
|
|
368.8
|
|
|||
Reimbursement for manufacturing of commercial supplies(2)
|
|
206.7
|
|
|
127.6
|
|
|
35.1
|
|
|||
Regeneron's share of profits (losses) in connection with commercialization of antibodies
|
|
209.3
|
|
|
(227.0
|
)
|
|
(442.6
|
)
|
|||
Other
|
|
(1.5
|
)
|
|
(24.1
|
)
|
|
84.0
|
|
|||
Total Antibody
|
|
1,172.1
|
|
|
559.0
|
|
|
553.7
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of research and development expenses - Discovery Agreement
|
|
54.1
|
|
|
154.4
|
|
|
138.8
|
|
|||
Reimbursement of research and development expenses - License and Collaboration Agreement
|
|
108.9
|
|
|
157.4
|
|
|
101.2
|
|
|||
Reimbursement of commercialization-related expenses(1)
|
|
10.3
|
|
|
8.9
|
|
|
7.0
|
|
|||
Amounts recognized in connection with up-front payments received
|
|
92.7
|
|
|
243.8
|
|
|
80.0
|
|
|||
Other
|
|
(11.3
|
)
|
|
(12.4
|
)
|
|
(3.5
|
)
|
|||
Total Immuno-oncology
|
|
254.7
|
|
|
552.1
|
|
|
323.5
|
|
|||
Total Sanofi collaboration revenue
|
|
$
|
1,426.8
|
|
|
$
|
1,111.1
|
|
|
$
|
877.2
|
|
|
|
|
|
|
|
|
||||||
(1) The corresponding commercialization-related costs incurred by us are recorded within Selling, general and administrative expense.
|
||||||||||||
(2) The corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing.
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2017
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
1,091.4
|
|
|
$
|
992.3
|
|
|
$
|
802.3
|
|
Reimbursement of development expenses
|
|
23.0
|
|
|
10.8
|
|
|
31.1
|
|
|||
Other
|
|
74.4
|
|
|
73.6
|
|
|
104.7
|
|
|||
Total Bayer collaboration revenue
|
|
$
|
1,188.8
|
|
|
$
|
1,076.7
|
|
|
$
|
938.1
|
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2017
|
||||||
EYLEA net product sales outside the United States
|
|
$
|
2,897.4
|
|
|
$
|
2,668.9
|
|
|
$
|
2,226.9
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
$
|
1,148.0
|
|
|
$
|
1,045.9
|
|
|
$
|
856.1
|
|
Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation
|
|
(56.6
|
)
|
|
(53.6
|
)
|
|
(53.8
|
)
|
|||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
1,091.4
|
|
|
$
|
992.3
|
|
|
$
|
802.3
|
|
|
|
|
|
|
|
|
||||||
Regeneron's net profit as a percentage of EYLEA net product sales outside the United States
|
|
38
|
%
|
|
37
|
%
|
|
36
|
%
|
|
|
Year Ended December 31,
|
||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2017
|
||||||
Teva collaboration revenue:
|
|
|
|
|
|
|
||||||
Reimbursement of research and development expenses
|
|
$
|
122.9
|
|
|
$
|
129.5
|
|
|
$
|
115.1
|
|
Other
|
|
83.6
|
|
|
115.1
|
|
|
106.4
|
|
|||
Total Teva collaboration revenue
|
|
206.5
|
|
|
244.6
|
|
|
221.5
|
|
|||
Other revenue
|
|
206.9
|
|
|
172.2
|
|
|
116.9
|
|
|||
Total other revenue
|
|
$
|
413.4
|
|
|
$
|
416.8
|
|
|
$
|
338.4
|
|
•
|
recognition of a portion of deferred revenue from up-front and other payments received 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;
|
•
|
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 agreements with BARDA related to REGN-EB3 for the treatment of Ebola;
|
•
|
recognition of revenue in connection with sequencing of samples by the RGC for its customers.
|
|
|
Year Ended December 31,
|
|
$ Change
|
||||||||||||||||
(In millions, except headcount data)
|
|
2019
|
|
2018
|
|
2017
|
|
2019 vs. 2018
|
|
2018 vs. 2017
|
||||||||||
Research and development
|
|
$
|
3,036.6
|
|
|
$
|
2,186.1
|
|
|
$
|
2,075.1
|
|
|
$
|
850.5
|
|
|
$
|
111.0
|
|
Selling, general, and administrative
|
|
1,834.8
|
|
|
1,556.2
|
|
|
1,320.4
|
|
|
278.6
|
|
|
235.8
|
|
|||||
Cost of goods sold(1)
|
|
362.3
|
|
|
180.0
|
|
|
202.5
|
|
|
182.3
|
|
|
(22.5
|
)
|
|||||
Cost of collaboration and contract manufacturing(2)
|
|
419.9
|
|
|
254.1
|
|
|
194.6
|
|
|
165.8
|
|
|
59.5
|
|
|||||
Total operating expenses
|
|
$
|
5,653.6
|
|
|
$
|
4,176.4
|
|
|
$
|
3,792.6
|
|
|
$
|
1,477.2
|
|
|
$
|
383.8
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Average headcount
|
|
7,773
|
|
|
6,906
|
|
|
5,780
|
|
|
867
|
|
|
1,126
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
(1) Cost of goods sold includes costs in connection with producing commercial supplies for products that are sold by Regeneron in the United States (i.e., EYLEA, Libtayo, and ARCALYST) and any royalties we are obligated to pay on such sales, period costs for our Limerick manufacturing facility, and amounts we are obligated to pay to Sanofi for its share of Libtayo U.S. gross profits.
|
||||||||||||||||||||
(2) Cost of collaboration and contract manufacturing primarily includes costs we incur in connection with producing commercial drug supplies for Sanofi and Bayer.
|
|
|
Year Ended December 31,
|
||||||||||
(In millions, except effective tax rate)
|
|
2019
|
|
2018
|
|
2017
|
||||||
Income tax expense
|
|
$
|
313.3
|
|
|
$
|
109.1
|
|
|
$
|
880.0
|
|
Effective tax rate
|
|
12.9
|
%
|
|
4.3
|
%
|
|
42.3
|
%
|
|
As of December 31,
|
|
|
||||||||
(In millions)
|
2019
|
|
2018
|
|
$ Change
|
||||||
Financial assets:
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
1,617.8
|
|
|
$
|
1,467.7
|
|
|
$
|
150.1
|
|
Marketable securities - current
|
1,596.5
|
|
|
1,342.2
|
|
|
254.3
|
|
|||
Marketable securities - noncurrent
|
3,256.8
|
|
|
1,755.0
|
|
|
1,501.8
|
|
|||
|
$
|
6,471.1
|
|
|
$
|
4,564.9
|
|
|
$
|
1,906.2
|
|
|
|
|
|
|
|
||||||
Working capital:
|
|
|
|
|
|
||||||
Current assets
|
$
|
7,689.1
|
|
|
$
|
6,447.6
|
|
|
$
|
1,241.5
|
|
Current liabilities
|
2,096.6
|
|
|
1,442.8
|
|
|
653.8
|
|
|||
|
$
|
5,592.5
|
|
|
$
|
5,004.8
|
|
|
$
|
587.7
|
|
|
|
Year Ended December 31,
|
|
$ Change
|
||||||||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2017
|
|
2019 vs. 2018
|
|
2018 vs. 2017
|
||||||||||
Cash flows provided by operating activities
|
|
$
|
2,430.0
|
|
|
$
|
2,195.1
|
|
|
$
|
1,307.1
|
|
|
$
|
234.9
|
|
|
$
|
888.0
|
|
Cash flows used in investing activities
|
|
$
|
(2,027.8
|
)
|
|
$
|
(1,463.0
|
)
|
|
$
|
(1,005.2
|
)
|
|
$
|
(564.8
|
)
|
|
$
|
(457.8
|
)
|
Cash flows used in financing activities
|
|
$
|
(252.1
|
)
|
|
$
|
(77.1
|
)
|
|
$
|
(24.4
|
)
|
|
$
|
(175.0
|
)
|
|
$
|
(52.7
|
)
|
10.8*
|
|
10.9*
|
|
10.10*
|
|
10.10.1*
|
|
10.10.2**
|
|
10.11
|
|
10.12*
|
|
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**
|
|
10.27.1**
|
|
10.27.2**
|
|
10.28**
|
|
10.29
|
|
21.1
|
|
23.1
|
|
24.1
|
|
31.1
|
|
31.2
|
|
32
|
101
|
Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Consolidated Balance Sheets as of December 31, 2019 and 2018; (ii) the Registrant's Consolidated Statements of Operations and Comprehensive Income for the years ended December 31, 2019, 2018, and 2017; (iii) the Registrant's Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2019, 2018, and 2017; (iv) the Registrant's Consolidated Statements of Cash Flows for the years ended December 31, 2019, 2018, and 2017; and (v) the notes to the Registrant's Consolidated Financial Statements.
|
104
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
|
_______
|
|
|
|
|
*
|
|
Portions of this document have been omitted and filed separately with the Commission pursuant to requests for confidential treatment pursuant to Rule 24b-2.
|
**
|
|
Certain confidential portions of this exhibit were omitted in accordance with Item 601(b)(10) of Regulation S-K.
|
+
|
|
Indicates a management contract or compensatory plan or arrangement.
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
Date:
|
February 7, 2020
|
|
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, 2020
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
/s/ ROBERT E. LANDRY
|
|
Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)
|
|
February 7, 2020
|
Robert E. Landry
|
|
|
|
|
/s/ CHRISTOPHER R. FENIMORE
|
|
Vice President, Controller (Principal Accounting Officer)
|
|
February 7, 2020
|
Christopher R. Fenimore
|
|
|
|
|
/s/ GEORGE D. YANCOPOULOS
|
|
President, Chief Scientific Officer, and Director
|
|
February 7, 2020
|
George D. Yancopoulos, M.D., Ph.D.
|
|
|
|
|
/s/ P. ROY VAGELOS
|
|
Chairman of the Board
|
|
February 7, 2020
|
P. Roy Vagelos, M.D.
|
|
|
|
|
/s/ BONNIE L. BASSLER
|
|
Director
|
|
February 7, 2020
|
Bonnie L. Bassler, Ph.D.
|
|
|
|
|
/s/ MICHAEL S. BROWN
|
|
Director
|
|
February 7, 2020
|
Michael S. Brown, M.D.
|
|
|
|
|
/s/ N. ANTHONY COLES
|
|
Director
|
|
February 7, 2020
|
N. Anthony Coles, M.D.
|
|
|
|
|
/s/ JOSEPH L. GOLDSTEIN
|
|
Director
|
|
February 7, 2020
|
Joseph L. Goldstein, M.D.
|
|
|
|
|
/s/ CHRISTINE A. POON
|
|
Director
|
|
February 7, 2020
|
Christine A. Poon
|
|
|
|
|
/s/ ARTHUR F. RYAN
|
|
Director
|
|
February 7, 2020
|
Arthur F. Ryan
|
|
|
|
|
/s/ GEORGE L. SING
|
|
Director
|
|
February 7, 2020
|
George L. Sing
|
|
|
|
|
/s/ MARC TESSIER-LAVIGNE
|
|
Director
|
|
February 7, 2020
|
Marc Tessier-Lavigne, Ph.D.
|
|
|
|
|
/s/ HUDA Y. ZOGHBI
|
|
Director
|
|
February 7, 2020
|
Huda Y. Zoghbi, M.D.
|
|
|
|
|
|
|
Page Numbers
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
1,617.8
|
|
|
$
|
1,467.7
|
|
Marketable securities
|
1,596.5
|
|
|
1,342.2
|
|
||
Accounts receivable - trade, net
|
2,100.0
|
|
|
1,723.7
|
|
||
Accounts receivable from Sanofi
|
260.6
|
|
|
226.4
|
|
||
Accounts receivable from Bayer
|
311.6
|
|
|
293.1
|
|
||
Inventories
|
1,415.5
|
|
|
1,151.2
|
|
||
Prepaid expenses and other current assets
|
387.1
|
|
|
243.3
|
|
||
Total current assets
|
7,689.1
|
|
|
6,447.6
|
|
||
|
|
|
|
||||
Marketable securities
|
3,256.8
|
|
|
1,755.0
|
|
||
Property, plant, and equipment, net
|
2,890.4
|
|
|
2,575.8
|
|
||
Deferred tax assets
|
824.2
|
|
|
828.7
|
|
||
Other noncurrent assets
|
144.7
|
|
|
127.4
|
|
||
Total assets
|
$
|
14,805.2
|
|
|
$
|
11,734.5
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
418.1
|
|
|
$
|
218.2
|
|
Accrued expenses and other current liabilities
|
1,086.8
|
|
|
772.1
|
|
||
Deferred revenue from Sanofi
|
395.5
|
|
|
246.7
|
|
||
Deferred revenue - other
|
196.2
|
|
|
205.8
|
|
||
Total current liabilities
|
2,096.6
|
|
|
1,442.8
|
|
||
|
|
|
|
||||
Finance lease liabilities
|
713.9
|
|
|
708.5
|
|
||
Deferred revenue from Sanofi
|
509.7
|
|
|
279.3
|
|
||
Deferred revenue - other
|
109.3
|
|
|
184.9
|
|
||
Other noncurrent liabilities
|
286.0
|
|
|
361.7
|
|
||
Total liabilities
|
3,715.5
|
|
|
2,977.2
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 11)
|
|
|
|
||||
|
|
|
|
||||
Stockholders' equity:
|
|
|
|
||||
Preferred Stock, $.01 par value; 30,000,000 shares authorized; issued and outstanding - none
|
—
|
|
|
—
|
|
||
Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized; shares issued and outstanding - 1,848,970 in 2019 and 1,911,354 in 2018
|
—
|
|
|
—
|
|
||
Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - 113,288,103 in 2019 and 111,084,951 in 2018
|
0.1
|
|
|
0.1
|
|
||
Additional paid-in capital
|
4,428.6
|
|
|
3,911.6
|
|
||
Retained earnings
|
7,379.8
|
|
|
5,254.3
|
|
||
Accumulated other comprehensive income (loss)
|
21.1
|
|
|
(12.3
|
)
|
||
Treasury Stock, at cost; 4,860,123 shares in 2019 and 3,990,021 shares in 2018
|
(739.9
|
)
|
|
(396.4
|
)
|
||
Total stockholders' equity
|
11,089.7
|
|
|
8,757.3
|
|
||
Total liabilities and stockholders' equity
|
$
|
14,805.2
|
|
|
$
|
11,734.5
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Statements of Operations
|
|
|
|
|
|
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Net product sales
|
|
$
|
4,834.4
|
|
|
$
|
4,106.2
|
|
|
$
|
3,718.5
|
|
Sanofi collaboration revenue
|
|
1,426.8
|
|
|
1,111.1
|
|
|
877.2
|
|
|||
Bayer collaboration revenue
|
|
1,188.8
|
|
|
1,076.7
|
|
|
938.1
|
|
|||
Other revenue
|
|
413.4
|
|
|
416.8
|
|
|
338.4
|
|
|||
|
|
7,863.4
|
|
|
6,710.8
|
|
|
5,872.2
|
|
|||
|
|
|
|
|
|
|
||||||
Expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
3,036.6
|
|
|
2,186.1
|
|
|
2,075.1
|
|
|||
Selling, general, and administrative
|
|
1,834.8
|
|
|
1,556.2
|
|
|
1,320.4
|
|
|||
Cost of goods sold
|
|
362.3
|
|
|
180.0
|
|
|
202.5
|
|
|||
Cost of collaboration and contract manufacturing
|
|
419.9
|
|
|
254.1
|
|
|
194.6
|
|
|||
|
|
5,653.6
|
|
|
4,176.4
|
|
|
3,792.6
|
|
|||
|
|
|
|
|
|
|
||||||
Income from operations
|
|
2,209.8
|
|
|
2,534.4
|
|
|
2,079.6
|
|
|||
|
|
|
|
|
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
||||||
Other income (expense), net
|
|
249.5
|
|
|
47.3
|
|
|
24.0
|
|
|||
Interest expense
|
|
(30.2
|
)
|
|
(28.2
|
)
|
|
(25.1
|
)
|
|||
|
|
219.3
|
|
|
19.1
|
|
|
(1.1
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income before income taxes
|
|
2,429.1
|
|
|
2,553.5
|
|
|
2,078.5
|
|
|||
|
|
|
|
|
|
|
||||||
Income tax expense
|
|
(313.3
|
)
|
|
(109.1
|
)
|
|
(880.0
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
19.38
|
|
|
$
|
22.65
|
|
|
$
|
11.27
|
|
Net income per share - diluted
|
|
$
|
18.46
|
|
|
$
|
21.29
|
|
|
$
|
10.34
|
|
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
|
109.2
|
|
|
107.9
|
|
|
106.3
|
|
|||
Weighted average shares outstanding - diluted
|
|
114.6
|
|
|
114.8
|
|
|
115.9
|
|
|||
|
|
|
|
|
|
|
||||||
Statements of Comprehensive Income
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
||||||
Unrealized gain (loss) on marketable securities
|
|
35.9
|
|
|
(7.0
|
)
|
|
12.7
|
|
|||
Unrealized (loss) gain on cash flow hedges
|
|
(2.5
|
)
|
|
0.7
|
|
|
0.8
|
|
|||
Comprehensive income
|
|
$
|
2,149.2
|
|
|
$
|
2,438.1
|
|
|
$
|
1,212.0
|
|
|
|
|
|
|
|
|
||||||
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, 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 for equity awards granted under long-term incentive plans
|
|
—
|
|
|
—
|
|
|
2.4
|
|
|
—
|
|
|
240.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
240.6
|
|
||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
|
|
—
|
|
|
—
|
|
|
(0.8
|
)
|
|
—
|
|
|
(301.7
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(301.7
|
)
|
||||||
Issuance of Common Stock for 401(k) Savings Plan
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19.4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19.4
|
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
524.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
524.6
|
|
||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,198.5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,198.5
|
|
||||||
Other comprehensive income, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13.4
|
|
|
—
|
|
|
—
|
|
|
13.4
|
|
||||||
Balance, December 31, 2017
|
|
1.9
|
|
|
—
|
|
|
109.5
|
|
|
0.1
|
|
|
3,512.9
|
|
|
2,946.7
|
|
|
0.6
|
|
|
(3.8
|
)
|
|
(316.2
|
)
|
|
6,144.1
|
|
||||||
Issuance of Common Stock for equity awards granted under long-term incentive plans
|
|
—
|
|
|
—
|
|
|
2.0
|
|
|
—
|
|
|
114.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
114.2
|
|
||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
|
|
—
|
|
|
—
|
|
|
(0.5
|
)
|
|
—
|
|
|
(187.2
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(187.2
|
)
|
||||||
Issuance of Common Stock for 401(k) Savings Plan
|
|
—
|
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
26.9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26.9
|
|
||||||
Repurchases of Common Stock
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.2
|
)
|
|
(80.2
|
)
|
|
(80.2
|
)
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
444.8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
444.8
|
|
||||||
Cumulative-effect adjustment upon adoption of new accounting standards
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(136.8
|
)
|
|
(6.6
|
)
|
|
—
|
|
|
—
|
|
|
(143.4
|
)
|
||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,444.4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,444.4
|
|
||||||
Other comprehensive loss, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6.3
|
)
|
|
—
|
|
|
—
|
|
|
(6.3
|
)
|
||||||
Balance, December 31, 2018
|
|
1.9
|
|
|
—
|
|
|
111.1
|
|
|
0.1
|
|
|
3,911.6
|
|
|
5,254.3
|
|
|
(12.3
|
)
|
|
(4.0
|
)
|
|
(396.4
|
)
|
|
8,757.3
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
210.3
|
|
|
148.2
|
|
|
145.5
|
|
|||
Non-cash compensation expense
|
|
464.3
|
|
|
427.4
|
|
|
507.3
|
|
|||
Other non-cash items, net
|
|
(29.3
|
)
|
|
12.1
|
|
|
63.5
|
|
|||
Deferred taxes
|
|
(130.6
|
)
|
|
(140.0
|
)
|
|
318.8
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Increase in Sanofi, Bayer, and trade accounts receivable
|
|
(473.1
|
)
|
|
(268.9
|
)
|
|
(362.7
|
)
|
|||
Increase in inventories
|
|
(335.5
|
)
|
|
(387.9
|
)
|
|
(314.2
|
)
|
|||
Increase in prepaid expenses and other assets
|
|
(130.4
|
)
|
|
(55.7
|
)
|
|
(113.3
|
)
|
|||
Increase (decrease) in deferred revenue
|
|
294.0
|
|
|
(194.5
|
)
|
|
(113.1
|
)
|
|||
Increase (decrease) in accounts payable, accrued expenses, and other liabilities
|
|
444.5
|
|
|
210.0
|
|
|
(23.2
|
)
|
|||
Total adjustments
|
|
314.2
|
|
|
(249.3
|
)
|
|
108.6
|
|
|||
Net cash provided by operating activities
|
|
2,430.0
|
|
|
2,195.1
|
|
|
1,307.1
|
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable and other securities
|
|
(3,202.4
|
)
|
|
(1,845.5
|
)
|
|
(1,277.2
|
)
|
|||
Sales or maturities of marketable securities
|
|
1,604.2
|
|
|
775.6
|
|
|
544.6
|
|
|||
Capital expenditures
|
|
(429.6
|
)
|
|
(383.1
|
)
|
|
(272.6
|
)
|
|||
Other
|
|
—
|
|
|
(10.0
|
)
|
|
—
|
|
|||
Net cash used in investing activities
|
|
(2,027.8
|
)
|
|
(1,463.0
|
)
|
|
(1,005.2
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||||||
Proceeds in connection with finance lease liabilities
|
|
—
|
|
|
—
|
|
|
57.0
|
|
|||
Payments in connection with finance lease liabilities
|
|
—
|
|
|
—
|
|
|
(19.9
|
)
|
|||
Proceeds from issuance of Common Stock
|
|
211.8
|
|
|
114.5
|
|
|
240.2
|
|
|||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(188.0
|
)
|
|
(187.2
|
)
|
|
(301.7
|
)
|
|||
Repurchases of Common Stock
|
|
(275.9
|
)
|
|
(4.4
|
)
|
|
—
|
|
|||
Net cash used in financing activities
|
|
(252.1
|
)
|
|
(77.1
|
)
|
|
(24.4
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net increase in cash, cash equivalents, and restricted cash
|
|
150.1
|
|
|
655.0
|
|
|
277.5
|
|
|||
|
|
|
|
|
|
|
||||||
Cash, cash equivalents, and restricted cash at beginning of period
|
|
1,480.2
|
|
|
825.2
|
|
|
547.7
|
|
|||
|
|
|
|
|
|
|
||||||
Cash, cash equivalents, and restricted cash at end of period
|
|
$
|
1,630.3
|
|
|
$
|
1,480.2
|
|
|
$
|
825.2
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest (net of amounts capitalized)
|
|
$
|
25.0
|
|
|
$
|
22.3
|
|
|
$
|
18.7
|
|
Cash paid for income taxes
|
|
$
|
342.3
|
|
|
$
|
205.6
|
|
|
$
|
754.8
|
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
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
|
|
2019
|
|
2018
|
|
2017
|
||||||
EYLEA
|
|
$
|
4,644.2
|
|
|
$
|
4,076.7
|
|
|
$
|
3,701.9
|
|
Libtayo
|
|
175.7
|
|
|
14.8
|
|
|
—
|
|
|||
ARCALYST
|
|
14.5
|
|
|
14.7
|
|
|
16.6
|
|
|||
|
|
$
|
4,834.4
|
|
|
$
|
4,106.2
|
|
|
$
|
3,718.5
|
|
|
Rebates, Chargebacks, and Discounts
|
|
Distribution-
Related Fees
|
|
Other Sales-
Related Deductions
|
|
Total
|
||||||||
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
|
|
||||
Provisions
|
423.2
|
|
|
242.9
|
|
|
61.8
|
|
|
727.9
|
|
||||
Credits/payments
|
(384.0
|
)
|
|
(238.5
|
)
|
|
(40.7
|
)
|
|
(663.2
|
)
|
||||
Balance as of December 31, 2019
|
$
|
80.3
|
|
|
$
|
46.4
|
|
|
$
|
29.4
|
|
|
$
|
156.1
|
|
|
|
Year Ended December 31,
|
||||||||||
Sanofi Collaboration Revenue
|
|
2019
|
|
2018
|
|
2017
|
||||||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of research and development expenses
|
|
$
|
277.7
|
|
|
$
|
265.3
|
|
|
$
|
508.4
|
|
Reimbursement of commercialization-related expenses
|
|
479.9
|
|
|
417.2
|
|
|
368.8
|
|
|||
Reimbursement for manufacturing of commercial supplies
|
|
206.7
|
|
|
127.6
|
|
|
35.1
|
|
|||
Regeneron's share of profits (losses) in connection with commercialization of antibodies
|
|
209.3
|
|
|
(227.0
|
)
|
|
(442.6
|
)
|
|||
Other
|
|
(1.5
|
)
|
|
(24.1
|
)
|
|
84.0
|
|
|||
Total Antibody
|
|
1,172.1
|
|
|
559.0
|
|
|
553.7
|
|
|||
Immuno-oncology:
|
|
|
|
|
|
|
||||||
Reimbursement of research and development expenses
|
|
163.0
|
|
|
311.8
|
|
|
240.0
|
|
|||
Reimbursement of commercialization-related expenses
|
|
10.3
|
|
|
8.9
|
|
|
7.0
|
|
|||
Amounts recognized in connection with up-front payments received
|
|
92.7
|
|
|
243.8
|
|
|
80.0
|
|
|||
Other
|
|
(11.3
|
)
|
|
(12.4
|
)
|
|
(3.5
|
)
|
|||
Total Immuno-oncology
|
|
254.7
|
|
|
552.1
|
|
|
323.5
|
|
|||
|
|
$
|
1,426.8
|
|
|
$
|
1,111.1
|
|
|
$
|
877.2
|
|
|
|
As of December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Accounts receivable
|
|
$
|
272.7
|
|
|
$
|
138.2
|
|
Deferred revenue
|
|
$
|
337.2
|
|
|
$
|
236.1
|
|
|
|
Year Ended
December 31, 2019
|
||
Increase due to shipments of commercial supplies to Sanofi
|
|
$
|
335.7
|
|
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(240.4
|
)
|
|
|
As of December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Accounts receivable, net
|
|
$
|
(16.7
|
)
|
|
$
|
77.9
|
|
Deferred revenue
|
|
$
|
568.0
|
|
|
$
|
289.9
|
|
|
|
Year Ended
December 31, 2019 |
||
Increase as a result of payment received from Sanofi in connection with the termination of the 2015 IO Discovery Agreement
|
|
$
|
415.9
|
|
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(92.7
|
)
|
Revenue recognized that was added to deferred revenue during the period
|
|
$
|
(48.4
|
)
|
|
|
Year Ended December 31,
|
||||||||||
Bayer EYLEA Collaboration Revenue
|
|
2019
|
|
2018
|
|
2017
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
1,091.4
|
|
|
$
|
992.3
|
|
|
$
|
802.3
|
|
Reimbursement of EYLEA development expenses
|
|
23.0
|
|
|
11.2
|
|
|
13.3
|
|
|||
Other
|
|
74.4
|
|
|
73.6
|
|
|
58.7
|
|
|||
|
|
$
|
1,188.8
|
|
|
$
|
1,077.1
|
|
|
$
|
874.3
|
|
|
|
As of December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Accounts receivable (recorded within Prepaid expenses and other current assets)
|
|
$
|
21.2
|
|
|
$
|
28.8
|
|
Deferred revenue
|
|
$
|
114.4
|
|
|
$
|
194.5
|
|
|
|
Year Ended
December 31, 2019 |
||
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(82.1
|
)
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
As of December 31, 2019
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate bonds
|
|
$
|
3,960.5
|
|
|
$
|
27.8
|
|
|
$
|
(0.2
|
)
|
|
$
|
3,988.1
|
|
U.S. government and government agency obligations
|
|
54.3
|
|
|
0.2
|
|
|
(0.1
|
)
|
|
54.4
|
|
||||
Sovereign bonds
|
|
26.9
|
|
|
0.4
|
|
|
—
|
|
|
27.3
|
|
||||
Commercial paper
|
|
92.3
|
|
|
—
|
|
|
—
|
|
|
92.3
|
|
||||
Certificates of deposit
|
|
72.3
|
|
|
0.1
|
|
|
—
|
|
|
72.4
|
|
||||
|
|
$
|
4,206.3
|
|
|
$
|
28.5
|
|
|
$
|
(0.3
|
)
|
|
$
|
4,234.5
|
|
|
|
|
|
|
|
|
|
|
||||||||
As of December 31, 2018
|
|
|
|
|
|
|
|
|
||||||||
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,
|
||||||
|
|
2019
|
|
2018
|
||||
Maturities within one year
|
|
$
|
1,596.5
|
|
|
$
|
1,342.2
|
|
Maturities after one year through five years
|
|
2,638.0
|
|
|
1,667.0
|
|
||
|
|
$
|
4,234.5
|
|
|
$
|
3,009.2
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
As of December 31, 2019
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
$
|
257.2
|
|
|
$
|
(0.2
|
)
|
|
$
|
41.1
|
|
|
$
|
—
|
|
|
$
|
298.3
|
|
|
$
|
(0.2
|
)
|
U.S. government and government agency obligations
|
17.3
|
|
|
(0.1
|
)
|
|
2.0
|
|
|
—
|
|
|
19.3
|
|
|
(0.1
|
)
|
||||||
|
$
|
274.5
|
|
|
$
|
(0.3
|
)
|
|
$
|
43.1
|
|
|
$
|
—
|
|
|
$
|
317.6
|
|
|
$
|
(0.3
|
)
|
|
|
|
|
|
|
||||||||||||||||||
As of December 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
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
|
)
|
•
|
Level 1 - Quoted prices in active markets for identical assets
|
•
|
Level 2 - Significant other observable inputs, such as quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-based valuations in which significant inputs used are observable
|
•
|
Level 3 - Significant other unobservable inputs
|
|
|
|
Fair Value Measurements at Reporting Date
|
||||||||
As of December 31, 2019
|
Fair Value
|
|
Level 1
|
|
Level 2
|
||||||
Available-for-sale debt securities:
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
3,988.1
|
|
|
—
|
|
|
$
|
3,988.1
|
|
|
U.S. government and government agency obligations
|
54.4
|
|
|
—
|
|
|
54.4
|
|
|||
Sovereign bonds
|
27.3
|
|
|
—
|
|
|
27.3
|
|
|||
Commercial paper
|
92.3
|
|
|
—
|
|
|
92.3
|
|
|||
Certificates of deposit
|
72.4
|
|
|
—
|
|
|
72.4
|
|
|||
Equity securities (unrestricted)
|
61.6
|
|
|
$
|
61.6
|
|
|
—
|
|
||
Equity securities (restricted)
|
557.2
|
|
|
557.2
|
|
|
—
|
|
|||
|
$
|
4,853.3
|
|
|
$
|
618.8
|
|
|
$
|
4,234.5
|
|
|
|
|
|
|
|
||||||
As of December 31, 2018
|
|
|
|
|
|
||||||
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,
|
||||||
|
2019
|
|
2018
|
||||
Raw materials
|
$
|
216.3
|
|
|
$
|
226.8
|
|
Work-in-process
|
727.7
|
|
|
571.1
|
|
||
Finished goods
|
70.6
|
|
|
24.4
|
|
||
Deferred costs
|
400.9
|
|
|
328.9
|
|
||
|
$
|
1,415.5
|
|
|
$
|
1,151.2
|
|
|
As of December 31,
|
||||||
|
2019
|
|
2018
|
||||
Land
|
$
|
230.8
|
|
|
$
|
199.0
|
|
Building and improvements
|
1,683.4
|
|
|
1,507.2
|
|
||
Leasehold improvements
|
97.6
|
|
|
97.0
|
|
||
Construction in progress
|
644.8
|
|
|
469.6
|
|
||
Laboratory equipment
|
850.7
|
|
|
773.7
|
|
||
Computer equipment and software
|
183.7
|
|
|
145.8
|
|
||
Furniture, office equipment, and other
|
121.8
|
|
|
112.2
|
|
||
|
3,812.8
|
|
|
3,304.5
|
|
||
Less, accumulated depreciation and amortization
|
(922.4
|
)
|
|
(728.7
|
)
|
||
|
$
|
2,890.4
|
|
|
$
|
2,575.8
|
|
|
As of December 31,
|
||||||
|
2019
|
|
2018
|
||||
Accrued payroll and related costs
|
$
|
344.4
|
|
|
$
|
261.8
|
|
Accrued clinical expenses
|
142.7
|
|
|
142.2
|
|
||
Accrued sales-related charges, deductions, and royalties
|
249.0
|
|
|
182.7
|
|
||
Income taxes payable
|
49.4
|
|
|
20.8
|
|
||
Other accrued expenses and liabilities
|
301.3
|
|
|
164.6
|
|
||
|
$
|
1,086.8
|
|
|
$
|
772.1
|
|
|
As of December 31,
|
||||||
|
2019
|
|
2018
|
||||
Current portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
395.5
|
|
|
$
|
246.7
|
|
Received or receivable from Bayer (see Note 3b)
|
49.2
|
|
|
44.4
|
|
||
Received or receivable from Teva (see Note 3c)
|
89.5
|
|
|
92.5
|
|
||
Other
|
57.5
|
|
|
68.9
|
|
||
|
$
|
591.7
|
|
|
$
|
452.5
|
|
Noncurrent portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 3a)
|
$
|
509.7
|
|
|
$
|
279.3
|
|
Received or receivable from Bayer (see Note 3b)
|
73.8
|
|
|
45.1
|
|
||
Received or receivable from Teva (see Note 3c)
|
24.9
|
|
|
102.0
|
|
||
Other
|
10.6
|
|
|
37.8
|
|
||
|
$
|
619.0
|
|
|
$
|
464.2
|
|
|
|
Year Ended
December 31, 2019
|
||
Amortization of right-of-use assets
|
|
$
|
14.4
|
|
Interest on lease liabilities
|
|
27.6
|
|
|
|
|
$
|
42.0
|
|
|
|
December 31,
|
|
|
|
2019
|
|
Remaining lease term (in years)
|
|
2.17
|
|
Discount rate
|
|
3.05
|
%
|
|
|
Operating Leases
|
|
Finance Leases
|
||||
2020
|
|
$
|
7.6
|
|
|
$
|
22.2
|
|
2021
|
|
6.6
|
|
|
21.9
|
|
||
2022
|
|
3.3
|
|
|
725.4
|
|
||
2023
|
|
2.0
|
|
|
—
|
|
||
2024
|
|
2.3
|
|
|
—
|
|
||
Thereafter
|
|
4.3
|
|
|
—
|
|
||
Total undiscounted lease payments
|
|
26.1
|
|
|
769.5
|
|
||
Imputed interest
|
|
(2.5
|
)
|
|
(50.1
|
)
|
||
Debt financing costs
|
|
—
|
|
|
(5.5
|
)
|
||
Total lease liabilities
|
|
$
|
23.6
|
|
|
$
|
713.9
|
|
|
|
Operating Leases
|
|
Capital and Facility Lease Obligations
|
||||
2019
|
|
$
|
10.4
|
|
|
$
|
26.4
|
|
2020
|
|
3.8
|
|
|
28.4
|
|
||
2021
|
|
3.4
|
|
|
27.9
|
|
||
2022
|
|
2.2
|
|
|
7.0
|
|
||
2023
|
|
1.5
|
|
|
—
|
|
||
Thereafter
|
|
4.1
|
|
|
—
|
|
||
|
|
$
|
25.4
|
|
|
$
|
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, 2018
|
|
28,279,696
|
|
|
$
|
319.28
|
|
|
|
|
|
|
||
2019:
|
Granted
|
|
3,271,222
|
|
|
$
|
366.65
|
|
|
|
|
|
||
|
Forfeited
|
|
(576,806
|
)
|
|
$
|
395.88
|
|
|
|
|
|
||
|
Expired
|
|
(300,581
|
)
|
|
$
|
460.37
|
|
|
|
|
|
||
|
Exercised
|
|
(2,064,254
|
)
|
|
$
|
103.51
|
|
|
|
|
|
||
Outstanding as of December 31, 2019
|
|
28,609,277
|
|
|
$
|
337.24
|
|
|
6.17
|
|
$
|
1,805.9
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vested and expected to vest as of December 31, 2019
|
|
27,524,704
|
|
|
$
|
335.73
|
|
|
6.06
|
|
$
|
1,800.5
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable as of December 31, 2019
|
|
19,291,335
|
|
|
$
|
318.15
|
|
|
4.90
|
|
$
|
1,763.9
|
|
|
|
Number of Options Granted
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Fair Value
|
|||||
2019:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
3,271,222
|
|
|
$
|
366.65
|
|
|
$
|
100.80
|
|
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
|
|
|
|
2019
|
|
2018
|
|
2017
|
|||
Expected volatility
|
|
28
|
%
|
|
29
|
%
|
|
31
|
%
|
Expected lives from grant date
|
|
5.0 years
|
|
|
4.9 years
|
|
|
5.1 years
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk-free interest rate
|
|
1.74
|
%
|
|
2.69
|
%
|
|
2.16
|
%
|
b.
|
Restricted Stock Awards and Restricted Stock Units
|
|
|
Number of Shares/Units
|
|
Weighted-Average Grant
Date Fair Value
|
||||
Balance as of December 31, 2018
|
|
472,630
|
|
|
$
|
386.10
|
|
|
2019:
|
Granted
|
|
698,103
|
|
|
$
|
356.33
|
|
|
Vested
|
|
(3,090
|
)
|
|
$
|
406.65
|
|
|
Forfeited/Cancelled
|
|
(5,857
|
)
|
|
$
|
385.90
|
|
Balance as of December 31, 2019
|
|
1,161,786
|
|
|
$
|
368.16
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
United States
|
$
|
2,011.2
|
|
|
$
|
2,151.7
|
|
|
$
|
1,964.7
|
|
Foreign
|
417.9
|
|
|
401.8
|
|
|
113.8
|
|
|||
|
$
|
2,429.1
|
|
|
$
|
2,553.5
|
|
|
$
|
2,078.5
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
444.6
|
|
|
$
|
223.7
|
|
|
$
|
560.3
|
|
State
|
1.9
|
|
|
4.8
|
|
|
(4.1
|
)
|
|||
Foreign
|
(2.6
|
)
|
|
20.6
|
|
|
4.8
|
|
|||
Total current tax expense
|
443.9
|
|
|
249.1
|
|
|
561.0
|
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
(132.0
|
)
|
|
687.6
|
|
|
317.1
|
|
|||
State
|
(1.7
|
)
|
|
(1.9
|
)
|
|
(1.3
|
)
|
|||
Foreign
|
3.1
|
|
|
(825.7
|
)
|
|
3.2
|
|
|||
Total deferred tax (benefit) expense
|
(130.6
|
)
|
|
(140.0
|
)
|
|
319.0
|
|
|||
|
$
|
313.3
|
|
|
$
|
109.1
|
|
|
$
|
880.0
|
|
|
Year Ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
U.S. federal statutory tax rate
|
21.0
|
%
|
|
21.0
|
%
|
|
35.0
|
%
|
Income tax credits
|
(4.6
|
)
|
|
(2.6
|
)
|
|
(1.3
|
)
|
Stock-based compensation
|
(2.5
|
)
|
|
(2.5
|
)
|
|
(9.0
|
)
|
Foreign-derived intangible income deduction
|
(1.6
|
)
|
|
(1.0
|
)
|
|
—
|
|
Taxation of non-U.S. operations
|
(1.0
|
)
|
|
(1.9
|
)
|
|
0.7
|
|
Non-deductible Branded Prescription Drug Fee
|
0.7
|
|
|
0.6
|
|
|
1.7
|
|
Sale of non-inventory related assets between foreign subsidiaries
|
—
|
|
|
(6.3
|
)
|
|
—
|
|
Impact of change in U.S. corporate tax rate (the Act)
|
—
|
|
|
(2.7
|
)
|
|
15.7
|
|
Domestic production activities deduction
|
—
|
|
|
—
|
|
|
(2.6
|
)
|
Other permanent differences
|
0.9
|
|
|
(0.3
|
)
|
|
2.1
|
|
Effective income tax rate
|
12.9
|
%
|
|
4.3
|
%
|
|
42.3
|
%
|
|
|
As of December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Deferred compensation
|
|
$
|
519.7
|
|
|
$
|
458.2
|
|
Fixed assets and intangible assets
|
|
192.0
|
|
|
107.8
|
|
||
Accrued expenses
|
|
75.9
|
|
|
53.3
|
|
||
Deferred revenue
|
|
22.0
|
|
|
20.2
|
|
||
Other
|
|
—
|
|
|
33.3
|
|
||
Total deferred tax assets
|
|
809.6
|
|
|
672.8
|
|
||
Valuation allowance
|
|
(7.0
|
)
|
|
—
|
|
||
Deferred tax assets, net of valuation allowance
|
|
802.6
|
|
|
672.8
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
||||
Other
|
|
(11.2
|
)
|
|
(2.7
|
)
|
||
Net deferred tax assets
|
|
$
|
791.4
|
|
|
$
|
670.1
|
|
|
|
2019
|
|
2018
|
|
2017
|
||||||
Balance as of January 1
|
|
$
|
189.5
|
|
|
$
|
146.2
|
|
|
$
|
117.2
|
|
Gross increases related to current year tax positions
|
|
37.9
|
|
|
51.4
|
|
|
49.0
|
|
|||
Gross (decreases) increases related to prior year tax positions
|
|
(7.2
|
)
|
|
5.6
|
|
|
(5.6
|
)
|
|||
Gross decreases due to settlements and lapse of statutes of limitations
|
|
(9.4
|
)
|
|
(13.7
|
)
|
|
(14.4
|
)
|
|||
Balance as of December 31
|
|
$
|
210.8
|
|
|
$
|
189.5
|
|
|
$
|
146.2
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Net income - basic and diluted
|
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
|
$
|
1,198.5
|
|
|
|
|
|
|
|
|
||||||
(Shares in millions)
|
|
|
|
|
|
|
||||||
Weighted average shares - basic
|
|
109.2
|
|
|
107.9
|
|
|
106.3
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
5.4
|
|
|
6.9
|
|
|
9.1
|
|
|||
Restricted stock
|
|
—
|
|
|
—
|
|
|
0.5
|
|
|||
Weighted average shares - diluted
|
|
114.6
|
|
|
114.8
|
|
|
115.9
|
|
|||
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
19.38
|
|
|
$
|
22.65
|
|
|
$
|
11.27
|
|
Net income per share - diluted
|
|
$
|
18.46
|
|
|
$
|
21.29
|
|
|
$
|
10.34
|
|
|
|
Year Ended December 31,
|
|||||||
(Shares in millions)
|
|
2019
|
|
2018
|
|
2017
|
|||
Stock options
|
|
18.4
|
|
|
14.9
|
|
|
9.2
|
|
|
|
December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Cash and cash equivalents
|
|
$
|
1,617.8
|
|
|
$
|
1,467.7
|
|
|
$
|
812.7
|
|
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
|
|
$
|
1,630.3
|
|
|
$
|
1,480.2
|
|
|
$
|
825.2
|
|
•
|
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 the 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 the Company’s 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 the Company’s shareholders consent, the effect of which is to require that shareholder action may only be taken at a duly convened meeting; and
|
•
|
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.
|
|
|
|
|
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.
|
|
*
|
Awards designated as annual awards will vest 50% on the second anniversary of the Grant Date and 50% on the fourth anniversary of the Grant Date. Awards designated as special awards will vest in their entirety on the fourth anniversary of the Grant Date.
|
|
|
|
|
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.
|
|
|
|
|
Regeneron Pharmaceuticals, Inc.
|
|
|
ID: [ ]
|
|
Notice of Grant of Performance Restricted
|
777 Old Saw Mill River Road
|
|
Stock Units and Performance Restricted Stock
|
Tarrytown, New York 10591
|
|
Unit Agreement (“Notice”)
|
|
|
|
||
|
||
[NAME]
|
Performance RSU Number:
|
[ ]
|
[ADDRESS]
|
Plan:
|
[ ]
|
|
ID:
|
[ ]
|
|
Level
|
Cumulative TSR
|
Payout (as percentage of Target PSU)
|
Maximum
|
+75%
|
225%
|
|
+69%
|
200%
|
|
+63%
|
175%
|
|
+57%
|
150%
|
|
+52%
|
125%
|
Target
|
+46%
|
100%
|
|
+34%
|
75%
|
Threshold
|
+22%
|
50%
|
(a)
|
Net Sales will be calculated on the basis of sales by BYL to Santen with the gross amount invoiced corresponding to [***] pursuant to the Santen Co-Promotion Agreement; and
|
(b)
|
[***], calculated in accordance with the Extended Co-Promotion Agreement, shall be added as a deduction in Section 1.65 of the LCA in the calculation of Net Sales. [***].
|
REGENERON IRELAND DESIGNATED ACTIVITY COMPANY
|
BAYER HEALTHCARE LLC
|
By: /s/Muriel O’Byrne
|
By: /s/Ganesh Kamath
|
DATE: December 19, 2019
|
DATE: December 19, 2019
|
|
Aggregate
|
Company
|
Regeneron
|
Territory Profit Split
|
|
|
|
|
|
Net Sales in the Territory
|
1000
|
1000
|
|
|
COGS
|
(50)
|
(50)
|
0
|
|
Shared Promotion Expenses
|
(350)
|
(300)
|
(50)
|
|
|
|
|
|
|
Territory Profits
|
600
|
|
|
300
|
Regeneron Shared Promotion Expenses
|
50
|
Regeneron Commercial Supply Costs
|
10
|
Regeneron Development Costs under Territory Development Plan
|
5
|
Regeneron Reimbursement Amount
|
65
|
|
Aggregate
|
Company
|
Regeneron
|
Global
True-Up
|
|
|
|
|
|
Development Costs under Global Development Plan
|
80
|
30
|
50
|
|
Other Shared Expenses
|
40
|
35
|
5
|
|
Total
|
120
|
65
|
55
|
(5)
|
Territory Profit Split
|
300
|
Regeneron Reimbursement Amount
|
200
|
Global True-Up
|
(5)
|
[***]
|
[***]
|
Quarterly True-up
|
[***]
|
|
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 Designated Activity 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, 2020
|
/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, 2020
|
/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
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Leonard S. Schleifer
|
Leonard S. Schleifer, M.D., Ph.D.
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
February 7, 2020
|
|
/s/ Robert E. Landry
|
Robert E. Landry
|
Executive Vice President, Finance and Chief Financial Officer
|
(Principal Financial Officer)
|
February 7, 2020
|