FORM 10-K
|
|
(Mark One)
|
|
|
(X)
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
|
|
|
|
|
For the fiscal year ended
December 31, 2013
|
|
|
|
|
|
|
|
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
|
|
(I.R.S. Employer Identification No.)
|
incorporation or organization)
|
|
|
|
|
|
777 Old Saw Mill River Road, Tarrytown, New York
|
|
10591-6707
|
(Address of principal executive offices)
|
|
(Zip Code)
|
Title of each class
|
|
Name of each exchange on which registered
|
Common Stock - par value $.001 per share
|
|
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
|
a
|
No
|
|
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.
|
Yes
|
|
No
|
a
|
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
|
a
|
No
|
|
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
|
Yes
|
a
|
No
|
|
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§232.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this form 10-K.
|
|
|
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
|
Yes
|
|
No
|
a
|
Class of Common Stock
|
|
Number of Shares
|
Class A Stock, $.001 par value
|
|
2,020,481
|
Common Stock, $.001 par value
|
|
97,907,887
|
|
|
|
|
Page Numbers
|
|
|
|
|
|
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
"ARCALYST
®
", "EYLEA
®
", "ZALTRAP
®
", "
VelocImmune
®
", "
VelociGene
®
", "
VelociMouse
®
", "
VelociMab
®
", and "
VelociSuite
®
" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners.
|
•
|
EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, which is available in the United States, European Union (EU), Japan, and certain other countries outside the United States for the treatment of neovascular age-related macular degeneration (wet AMD) and macular edema following central retinal vein occlusion (CRVO). Net product sales of EYLEA in the United States were
$1,408.7 million
in 2013, $837.9 million in 2012, and $24.8 million in 2011. Bayer HealthCare records revenue from sales of EYLEA outside the United States. EYLEA net product sales outside of the United States commenced in the fourth quarter of 2012, and were
$472.1 million
in 2013 and $19.0 million in 2012.
|
•
|
ZALTRAP
®
(ziv-aflibercept) Injection for Intravenous Infusion, known in the scientific literature as VEGF Trap, which is available in the United States, EU, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Regulatory applications for marketing authorization of ZALTRAP for the treatment of previously treated mCRC patients in other countries have also been submitted and are currently under review by the respective regulatory agencies. We and Sanofi globally collaborate on the development and commercialization of ZALTRAP, and share profits and losses from commercialization of ZALTRAP, except for Japan, where we are entitled to receive a percentage of the sales of ZALTRAP, as described below. ZALTRAP net product sales, which are recorded by Sanofi, commenced in the United States in August 2012 and in Europe in the first quarter of 2013, and were
$70.2 million
in 2013 and $31.7 million in 2012.
|
•
|
ARCALYST
®
(rilonacept) Injection for Subcutaneous Use, which is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children 12 and older. CAPS are a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. Net product sales of ARCALYST totaled
$17.1 million
in
2013
, $
20.2 million
in
2012
, and $
19.9 million
in
2011
.
|
•
|
EYLEA, which is in clinical trials for the treatment of DME and macular edema following BRVO in collaboration with Bayer HealthCare; and
|
•
|
ZALTRAP, which is being studied in combination with our angiopoietin-2 inhibitor (nesvacumab) in oncology in collaboration with Sanofi.
|
•
|
Sarilumab (REGN88), an antibody to the interleukin-6 receptor (IL-6R), which is being developed in rheumatoid arthritis and non-infectious uveitis;
|
•
|
Alirocumab (REGN727), an antibody to Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), which is being developed for low-density lipoprotein (LDL) cholesterol reduction;
|
•
|
Dupilumab (REGN668), an antibody to the interleukin-4 receptor alpha (IL-4R), which is being developed in atopic dermatitis, asthma, and nasal polyposis;
|
•
|
Enoticumab (REGN421), an antibody to Delta-like ligand-4 (Dll4), a novel angiogenesis target, which is being developed in oncology;
|
•
|
Nesvacumab (REGN910), an antibody to angiopoietin-2 (Ang2), another novel angiogenesis target, which is being developed in oncology;
|
•
|
REGN1033, an antibody to myostatin (GDF8), which is being developed in skeletal muscle disorders; and
|
•
|
REGN2009, an antibody in clinical development against an undisclosed target.
|
•
|
REGN1400, an antibody to ErbB3, which is being developed in oncology;
|
•
|
REGN1154, an antibody in clinical development against an undisclosed target;
|
•
|
REGN1500, an antibody in clinical development against an undisclosed target;
|
•
|
REGN1193, an antibody in clinical development against an undisclosed target;
|
•
|
REGN1908-1909, an antibody combination in clinical development against an undisclosed target; and
|
•
|
Fasinumab (REGN475), an antibody to Nerve Growth Factor (NGF), which is being developed for the treatment of pain and is currently on clinical hold by the FDA.
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
|
Indication
|
|
Territory
|
Lucentis
®
|
|
Approved
|
|
Novartis/Genentech
|
|
Wet AMD, DME, macular edema following RVO, choroidal neovascularization secondary to pathologic myopia, and other eye indications
|
|
Worldwide
|
Avastin
®
(off-label)
|
|
Used to treat wet AMD, DME, and macular edema following RVO
|
|
Genentech
|
|
Wet AMD, DME, and macular edema following RVO
|
|
Sold worldwide
Being evaluated in trials in the United Kingdom, Canada, Brazil, Germany, and other countries
|
Conbercept
|
|
Approved in China for wet AMD
In development for other eye indications
|
|
Chengdu Kanghong Pharmaceutical Group
|
|
Wet AMD
|
|
China
|
Fovista
TM
, an aptamer directed against PDGF-B
|
|
In development (Phase 3 trials initiated in 2013 evaluating multiple combinations of Fovista
TM
, including Lucentis
®
+ Fovista
TM
, Avastin
®
+ Fovista
TM
, and EYLEA + Fovista
TM
)
|
|
Ophthotech Corporation
|
|
Wet AMD
|
|
—
|
ESBA1008, a single chain antibody fragment directed against VEGF-A
|
|
In development (Phase 2 trial initiated in 2013 comparing ESBA1008 and EYLEA)
|
|
Novartis
|
|
Wet AMD
|
|
—
|
Anti-VEGF-A-DARPin
®
|
|
In development (Phase 2)
|
|
Allergan
|
|
Wet AMD and related conditions
|
|
—
|
Bi-specific antibody
R06867461
|
|
In development (Phase 1)
|
|
Genentech
|
|
Wet AMD
|
|
—
|
Lucentis
®
Sustained Delivery System
|
|
In development (Phase 1)
|
|
Genentech
|
|
Wet AMD and related conditions
|
|
|
Competitor Product/Product Candidate
|
|
Commercial or
Development
Status
|
|
Competitor
|
|
Indication
|
|
Territory
|
Avastin
®
|
|
Approved and launched in 2004
|
|
Genentech
|
|
Certain cancers
|
|
Worldwide
|
Oral medications that target tumor cell growth and new vasculature formation that fuels growth of tumors
|
|
Being sold and marketed
|
|
Pfizer, Amgen (together with its partner Bayer HealthCare), GlaxoSmithKline, and Bayer HealthCare
|
|
Certain cancers
|
|
Worldwide
|
Other VEGF antagonists
|
|
In various phases of development
|
|
Novartis, Amgen, Imclone LLC/Eli Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, and Aveo
|
|
Certain cancers
|
|
—
|
Regeneron Antibody
Program
|
|
Competitor
|
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Target
|
Alirocumab (Phase 3)
Target: PCSK9
|
|
Amgen
|
|
Evolocumab (AMG-145)
|
|
In development (Phase 3)
|
|
Antibody against PCSK9
|
|
|
Pfizer
|
|
Bococizumab (RN316 / PF-04950615
|
|
In development (Phase 3)
|
|
Antibody against PCSK9
|
|
|
Genentech
|
|
RG7652
|
|
In development (Phase 2)
|
|
Antibody against PCSK9
|
|
|
Eli Lilly
|
|
LY3015014
|
|
In development (Phase 2)
|
|
Antibody against PCSK9
|
|
|
Bristol-Myers Squibb
|
|
BMS-962476
|
|
In development (Phase 1)
|
|
Adnectin against PCSK9
|
|
|
Alnylam (in partnership with The Medicines Company)
|
|
ALN-PCS
|
|
In development
|
|
RNAi against PCSK9
|
Regeneron Antibody
Program
|
|
Competitor
|
|
Competitor
Product/Product
Candidate
|
|
Commercial or
Development
Status
|
|
Target
|
Sarilumab (Phase 3)
Target: IL-6R
|
|
Roche
|
|
Tocilizumab (Actemra
®
)
|
|
Approved
|
|
Antibody against IL-6R for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis
|
|
|
Johnson & Johnson (in partnership with GlaxoSmithKline)
|
|
Sirukumab
|
|
In development (Phase 3)
|
|
Antibody against IL-6
|
|
|
Bristol-Myers Squibb (in partnership with Alder Biopharmaceuticals, Inc.)
|
|
Clazakizumab
|
|
In development (Phase 2)
|
|
Antibody against IL-6
|
|
|
Ablynx (in partnership with AbbVie)
|
|
ALX-0061
|
|
In development (Phase 2)
|
|
Antibody against IL-6R
|
|
|
R-Pharm
|
|
Olokizumab
|
|
In development (Phase 2)
|
|
Antibody against IL-6
|
|
|
Pfizer
|
|
PF-04236921
|
|
In development (Phase 1)
|
|
Antibody against IL-6
|
|
|
Roche
|
|
SA 237
|
|
In development (Phase 1)
|
|
Antibody against IL-6R
|
Dupilumab (Phase 2)
Target: IL-4R
|
|
Roche
|
|
Lebrikizumab
|
|
In development (Phase 3)
|
|
Antibody against IL-13
|
|
|
Teva
|
|
Reslizumab
|
|
In development (Phase 3)
|
|
Antibody against IL-5
|
|
|
GlaxoSmithKline
|
|
Mepolizumab
|
|
In development (Phase 3)
|
|
Antibody against IL-5
|
|
|
AstraZeneca
|
|
Benralizumab
|
|
In development (Phase 3)
|
|
Antibody against IL-5R
|
|
|
AstraZeneca
|
|
Tralokinumab
|
|
In development (Phase 2)
|
|
Antibody against IL-13
|
|
|
Novartis
|
|
QBX258
|
|
In development (Phase 2)
|
|
Fixed dose combination of antibodies against IL-4 and IL-13
|
|
|
GlaxoSmithKline
|
|
GSK2434735
|
|
In development (Phase 1)
|
|
Bi-specific antibody against IL-4 and IL-13
|
•
|
effectiveness of the commercial strategy in and outside the United States for the marketing of EYLEA, including pricing strategy and the continued effectiveness of efforts to obtain, and the timing of obtaining, adequate third-party reimbursements;
|
•
|
maintaining and successfully monitoring commercial manufacturing arrangements for EYLEA with third parties who perform fill/finish or other steps in the manufacture of EYLEA to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor pharmaceutical manufacturing facilities;
|
•
|
our ability to meet the demand for commercial supplies of EYLEA;
|
•
|
our ability to effectively communicate to the marketplace the benefits of the dosing regimen of EYLEA as compared to the dosing regimen of Lucentis
®
, and the willingness of retinal specialists and patients to switch from Lucentis
®
or off-label use of Avastin
®
to EYLEA;
|
•
|
the ability of patients, retinal specialists, and other providers to obtain and maintain sufficient coverage and reimbursement from third-party payers, including Medicare and Medicaid in the United States and other government and private payers in the United States and foreign jurisdictions;
|
•
|
our ability to maintain sales of EYLEA in the face of competitive products, including those currently in clinical development; and
|
•
|
the effect of new health care legislation currently being implemented in the United States.
|
•
|
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 and the cost of currency exchange;
|
•
|
our ability to deploy overseas funds in an efficient manner;
|
•
|
adverse tax consequences, including those that might result from the failure to operate in conformity with the requirements for certain tax treatment, tax incentives, or grants;
|
•
|
tariffs, trade protection measures, import or export licensing requirements, trade embargoes, and other trade barriers;
|
•
|
difficulties in attracting and retaining qualified personnel; and
|
•
|
cultural differences in the conduct of business.
|
•
|
fluctuations in our operating results, in particular net product sales of EYLEA and, to a lesser degree, sales of ZALTRAP;
|
•
|
if any of our product candidates or our new indications for our marketed products receive regulatory approval, net product sales of, and profits from, these product candidates and new indications;
|
•
|
market acceptance of, and fluctuations in market share for, our marketed products, especially EYLEA;
|
•
|
whether our net products sales and net profits underperform, meet, or exceed the expectations of investors or analysts;
|
•
|
announcement of actions by the FDA or foreign regulatory authorities or their respective advisory committees regarding our, or our collaborators', or our competitors', currently pending or future application(s) for regulatory approval of product candidate(s) or new indications for marketed products;
|
•
|
announcement of submission of an application for regulatory approval of one or more of our, or our competitors', product candidates or new indications for marketed products;
|
•
|
progress, delays, or results in clinical trials of our or our competitors’ product candidates or new indications for marketed products;
|
•
|
announcement of technological innovations or product candidates by us or competitors;
|
•
|
claims by others that our products or technologies infringe their patents;
|
•
|
challenges by others to our patents in the European Patent Office and in the U.S. Patent and Trademark Office;
|
•
|
public concern as to the safety or effectiveness of any of our marketed products or product candidates or new indications for our marketed products;
|
•
|
pricing or reimbursement actions or decisions by government authorities or insurers affecting the coverage or reimbursement 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 collaborative partners or key customers;
|
•
|
developments in the biotechnology industry or in government regulation of healthcare, including those relating to compounding;
|
•
|
large sales of our Common Stock by our executive officers, directors, or significant shareholders;
|
•
|
changes in tax rates, laws, or interpretation of tax laws;
|
•
|
arrivals and departures of key personnel; and
|
•
|
general market conditions.
|
•
|
our current executive officers and directors beneficially owned 10.8% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options held by such persons which are exercisable within 60 days of
December 31, 2013
, and 22.9% 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, 2013
; and
|
•
|
our four largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately 42.9% 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
|
•
|
authorization to issue “blank check” preferred stock, which is preferred stock that can be created and issued by the board of directors without prior shareholder approval, with rights senior to those of our Common Stock and Class A Stock;
|
•
|
a staggered board of directors, so that it would take three successive annual meetings to replace all of our directors;
|
•
|
a requirement that removal of directors may only be effected for cause and only upon the affirmative vote of at least eighty percent (80%) of the outstanding shares entitled to vote for directors, as well as a requirement that any vacancy on the board of directors may be filled only by the remaining directors;
|
•
|
a provision whereby any action required or permitted to be taken at any meeting of shareholders may be taken without a meeting, only if, prior to such action, all of our shareholders consent, the effect of which is to require that shareholder action may only be taken at a duly convened meeting;
|
•
|
a requirement that any shareholder seeking to bring business before an annual meeting of shareholders must provide timely notice of this intention in writing and meet various other requirements; and
|
•
|
under the New York Business Corporation Law, in addition to certain restrictions which may apply to “business combinations” involving our company and an “interested shareholder”, a plan of merger or consolidation of our company must be approved by two-thirds of the votes of all outstanding shares entitled to vote thereon. See the risk factor above captioned
“Our existing shareholders may be able to exert significant influence over matters requiring shareholder approval and over our management.”
|
Location
|
|
Square Footage
|
|
Expiration
|
|
Current Monthly Base Rental Charges
(1)
|
|
Renewal Option Available
|
|||
Tarrytown, New York
|
|
664,000
|
|
|
June 2024 - June 2029
|
|
$
|
2,239,000
|
|
|
Three 5-year terms
|
Tarrytown, New York
(2)
|
|
297,000
|
|
|
June 2029
|
|
—
|
|
Three 5-year terms
|
|
|
High
|
|
Low
|
||||
2012
|
|
|
|
|
||||
First Quarter
|
|
$
|
121.39
|
|
|
$
|
56.01
|
|
Second Quarter
|
|
145.04
|
|
|
107.31
|
|
||
Third Quarter
|
|
153.98
|
|
|
111.50
|
|
||
Fourth Quarter
|
|
188.95
|
|
|
136.13
|
|
||
|
|
|
|
|
||||
2013
|
|
|
|
|
||||
First Quarter
|
|
$
|
185.78
|
|
|
$
|
154.16
|
|
Second Quarter
|
|
283.99
|
|
|
177.12
|
|
||
Third Quarter
|
|
319.83
|
|
|
225.78
|
|
||
Fourth Quarter
|
|
319.50
|
|
|
257.69
|
|
|
|
12/31/2008
|
|
12/31/2009
|
|
12/31/2010
|
|
12/31/2011
|
|
12/31/2012
|
|
12/31/2013
|
||||||||||||
Regeneron
|
$
|
100.00
|
|
|
$
|
131.70
|
|
|
$
|
178.81
|
|
|
$
|
301.91
|
|
|
$
|
931.75
|
|
|
$
|
1,499.13
|
|
|
NASDAQ Pharm
|
100.00
|
|
|
112.36
|
|
|
121.80
|
|
|
130.38
|
|
|
173.45
|
|
|
285.96
|
|
|||||||
NQ US Pharm
|
100.00
|
|
|
118.85
|
|
|
121.94
|
|
|
143.27
|
|
|
163.78
|
|
|
222.22
|
|
|||||||
NASDAQ US
|
100.00
|
|
|
143.74
|
|
|
170.23
|
|
|
171.13
|
|
|
202.46
|
|
|
281.91
|
|
|||||||
S&P 500
|
100.00
|
|
|
123.45
|
|
|
139.23
|
|
|
139.23
|
|
|
157.90
|
|
|
204.63
|
|
Period
|
|
Total Number of Shares (or Units) Purchased
|
|
Average Price Paid per Share (or Unit)
|
|
Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs
|
|
Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs
|
|||||
|
|
|
|
|
|
|
|
|
|||||
12/1/2013-12/31/2013
|
|
57,433
|
|
|
$
|
272.73
|
|
|
—
|
|
|
—
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
|
|
(In thousands, except per share data)
|
||||||||||||||||||
Statement of Operations Data
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
|
$
|
1,425,839
|
|
|
$
|
858,093
|
|
|
$
|
44,686
|
|
|
$
|
25,254
|
|
|
$
|
18,364
|
|
Collaboration revenue
|
|
650,400
|
|
|
493,913
|
|
|
369,681
|
|
|
386,725
|
|
|
314,457
|
|
|||||
Technology licensing and other revenue
|
|
28,506
|
|
|
26,471
|
|
|
31,457
|
|
|
47,095
|
|
|
46,447
|
|
|||||
|
|
2,104,745
|
|
|
1,378,477
|
|
|
445,824
|
|
|
459,074
|
|
|
379,268
|
|
|||||
Expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
859,947
|
|
|
625,554
|
|
|
529,506
|
|
|
489,252
|
|
|
398,762
|
|
|||||
Selling, general, and administrative
|
|
329,415
|
|
|
210,755
|
|
|
117,261
|
|
|
65,201
|
|
|
52,923
|
|
|||||
Cost of goods sold
|
|
118,048
|
|
|
83,927
|
|
|
4,216
|
|
|
2,093
|
|
|
1,686
|
|
|||||
Cost of collaboration manufacturing
|
|
37,307
|
|
|
528
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
|
1,344,717
|
|
|
920,764
|
|
|
650,983
|
|
|
556,546
|
|
|
453,371
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) from operations
|
|
760,028
|
|
|
457,713
|
|
|
(205,159
|
)
|
|
(97,472
|
)
|
|
(74,103
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Other income (expense)
|
|
(46,668
|
)
|
|
(43,292
|
)
|
|
(17,733
|
)
|
|
(6,996
|
)
|
|
2,151
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) before income taxes
|
|
713,360
|
|
|
414,421
|
|
|
(222,892
|
)
|
|
(104,468
|
)
|
|
(71,952
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income tax (expense) benefit
(1)
|
|
(288,998
|
)
|
|
335,848
|
|
|
1,132
|
|
|
—
|
|
|
4,122
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss)
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
|
$
|
(221,760
|
)
|
|
$
|
(104,468
|
)
|
|
$
|
(67,830
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss) per share - basic
|
|
$
|
4.33
|
|
|
$
|
7.92
|
|
|
$
|
(2.45
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
(0.85
|
)
|
Net income (loss) per share - diluted
|
|
$
|
3.81
|
|
|
$
|
6.75
|
|
|
$
|
(2.45
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
(0.85
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
As of December 31,
|
||||||||||||||||||
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrestricted and restricted cash, cash equivalents, and marketable securities (current and non-current)
|
|
$
|
1,083,875
|
|
|
$
|
587,511
|
|
|
$
|
810,550
|
|
|
$
|
626,939
|
|
|
$
|
390,010
|
|
Total assets
|
|
2,951,013
|
|
|
2,080,490
|
|
|
1,323,583
|
|
|
1,089,432
|
|
|
741,202
|
|
|||||
Notes payable (current and non-current)
|
|
320,315
|
|
|
296,518
|
|
|
275,019
|
|
|
—
|
|
|
—
|
|
|||||
Facility lease obligations (current and non-current)
|
|
185,197
|
|
|
160,810
|
|
|
160,514
|
|
|
160,030
|
|
|
109,022
|
|
|||||
Capital lease obligations (current and non-current)
|
|
126
|
|
|
1,309
|
|
|
2,506
|
|
|
2,829
|
|
|
—
|
|
|||||
Stockholders' equity
|
|
1,952,076
|
|
|
1,245,385
|
|
|
485,732
|
|
|
527,815
|
|
|
396,762
|
|
ITEM 7.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
EYLEA (aflibercept) Injection, which is available in the United States, EU, Japan, and certain other countries outside the United States for the treatment of wet AMD and macular edema following CRVO. Net product sales of EYLEA in the United States were
$1,408.7 million
in
2013
, $
837.9 million
in
2012
, and $
24.8 million
in
2011
. Bayer HealthCare records revenue from sales of EYLEA outside the United States. EYLEA net product sales outside of the United States commenced in the fourth quarter of 2012, and were
$472.1 million
in
2013
and
$19.0 million
in
2012
.
|
•
|
ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion, which is available in the United States, EU, and certain other countries for treatment, in combination with FOLFIRI, of patients with mCRC that is resistant to or has progressed following an oxaliplatin-containing regimen. Regulatory applications for marketing authorization of ZALTRAP for the treatment of previously treated mCRC patients in other countries have also been submitted and are currently under review by the respective regulatory agencies.
|
•
|
ARCALYST (rilonacept) Injection for Subcutaneous Use, which is available in the United States for the treatment of CAPS, including FCAS and MWS, in adults and children 12 and older. CAPS are a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Net product sales of ARCALYST totaled
$17.1 million
in
2013
, $
20.2 million
in
2012
, and $
19.9 million
in
2011
. We do not expect future net product sales of ARCALYST for the treatment of CAPS to be significant.
|
•
|
EYLEA, which is in clinical trials for the treatment of DME and macular edema following BRVO in collaboration with Bayer HealthCare; and
|
•
|
ZALTRAP, which is being studied in combination with our angiopoietin-2 inhibitor (nesvacumab) in oncology in collaboration with Sanofi.
|
•
|
Sarilumab (REGN88), an antibody to IL-6R, which is being developed in rheumatoid arthritis and non-infectious uveitis;
|
•
|
Alirocumab (REGN727), an antibody to PCSK9, which is being developed for LDL cholesterol reduction;
|
•
|
Dupilumab (REGN668), an antibody to IL-4R, which is being developed in atopic dermatitis, asthma, and nasal polyposis;
|
•
|
Enoticumab (REGN421), an antibody to Dll4, a novel angiogenesis target, which is being developed in oncology;
|
•
|
Nesvacumab (REGN910), an antibody to Ang2, another novel angiogenesis target, which is being developed in oncology;
|
•
|
REGN1033, an antibody to GDF8, which is being developed in skeletal muscle disorders; and
|
•
|
REGN2009, an antibody in clinical development against an undisclosed target.
|
•
|
REGN1400, an antibody to ErbB3, which is being developed in oncology;
|
•
|
REGN1154, an antibody in clinical development against an undisclosed target;
|
•
|
REGN1500, an antibody in clinical development against an undisclosed target;
|
•
|
REGN1193, an antibody in clinical development against an undisclosed target;
|
•
|
REGN1908-1909, an antibody combination in clinical development against an undisclosed target; and
|
•
|
Fasinumab (REGN475), an antibody to NGF, which is being developed for the treatment of pain and is currently on clinical hold by the FDA.
|
|
|
2013 and 2014 Events to Date
|
|
2014 Plans
|
Sarilumab (IL-6R Antibody)
|
|
Initiated SARIL-RA-ASCERTAIN and SARIL-RA-COMPARE Phase 3 studies in rheumatoid arthritis
|
|
Continue enrollment in Phase 3 SARIL-RA program
|
|
|
Reported positive results from SARIL-RA- MOBILITY study
|
|
Continue patient enrollment in SARIL-NIU-SATURN Phase 2 study in non-infectious uveitis
|
|
|
Initiated SARIL-NIU-SATURN Phase 2 study in non-infectious uveitis
|
|
Initiate additional clinical studies
|
Alirocumab (PCSK9 Antibody)
|
|
Completed patient enrollment in majority of Phase 3 ODYSSEY trials
|
|
Continue enrollment of Phase 3 ODYSSEY OUTCOMES and ODYSSEY CHOICE I and II trials
|
|
|
Reported positive results from Phase 3 ODYSSEY MONO trial
|
|
Report results from additional Phase 3 ODYSSEY trials
|
|
|
Initiated Phase 3 ODYSSEY CHOICE I and ODYSSEY CHOICE II trials
|
|
|
Dupilumab (IL-4R Antibody)
|
|
Reported results for Phase 1b studies in atopic dermatitis
|
|
Continue patient enrollment in Phase 2 trials
|
|
|
Reported results from Phase 2a study in asthma. Results were also published online in the
New England Journal of Medicine
.
|
|
Report results from Phase 2a and Phase 2b studies in atopic dermatitis
|
|
|
|
Initiate Phase 3 studies
|
|
|
|
Reported results from Phase 2 study in atopic dermatitis
|
|
|
|
|
Initiated Phase 2b trials in atopic dermatitis and asthma
|
|
|
|
|
Initiated Phase 2 trial in nasal polyposis
|
|
|
Enoticumab (Dll4 Antibody)
|
|
Continued patient enrollment in Phase 1 program
|
|
Complete patient enrollment in the expansion of the Phase 1 program
|
Nesvacumab (Ang2 Antibody)
|
|
Continued patient enrollment in Phase 1 program
|
|
Complete patient enrollment in the Phase 1b program in advanced malignancies
|
|
|
|
|
Initiate clinical development in ophthalmology
|
REGN1033 (GDF8 Antibody)
|
|
Continued patient enrollment in Phase 1 program
|
|
Complete patient enrollment in Phase 1 and Phase 2a programs
|
|
|
Initiated Phase 2a study
|
|
|
REGN2009 (target not disclosed)
|
|
Initiated Phase 1 program
|
|
Continue patient enrollment in Phase 1 program
|
REGN1400 (ErbB3 Antibody)
|
|
Continued patient enrollment in Phase 1 program
|
|
Continue patient enrollment in Phase 1 program
|
REGN1154 (target not disclosed)
|
|
Completion of Phase 1 program
|
|
|
REGN1500 (target not disclosed)
|
|
Continued patient enrollment in Phase 1 program
|
|
Continue patient enrollment in Phase 1 program
|
REGN1193 (target not disclosed)
|
|
Initiated Phase 1 program
|
|
Continue patient enrollment in Phase 1 program
|
REGN1908-1909 (target not disclosed)
|
|
Initiated Phase 1 program
|
|
Continue patient enrollment in Phase 1 program
|
REGN2176-3 (PDGFR-beta Antibody in combination with EYLEA)
|
|
Initiated Phase 1 program
|
|
Continue patient enrollment in Phase 1 program
|
Fasinumab (NGF Antibody)
|
|
On clinical hold
|
|
Determine future development plan
|
•
|
It requires an assumption (or assumptions) regarding a future outcome; and
|
•
|
Changes in the estimate or the use of different assumptions to prepare the estimate could have a material effect on our results of operations or financial condition.
|
(In millions)
|
Rebates &
Chargebacks
|
|
Distribution-
Related
Fees
|
|
Other Sales-
Related
Deductions
|
|
Total
|
||||||||
Balance as of December 31, 2011
|
$
|
0.6
|
|
|
$
|
1.5
|
|
|
$
|
0.2
|
|
|
$
|
2.3
|
|
Provision related to current period sales
|
14.2
|
|
|
45.0
|
|
|
3.0
|
|
|
62.2
|
|
||||
Credits/payments
|
(11.8
|
)
|
|
(31.2
|
)
|
|
(2.7
|
)
|
|
(45.7
|
)
|
||||
Balance as of December 31, 2012
|
3.0
|
|
|
15.3
|
|
|
0.5
|
|
|
18.8
|
|
||||
Provision related to current period sales
|
25.9
|
|
|
63.0
|
|
|
1.0
|
|
|
89.9
|
|
||||
Credits/payments
|
(24.5
|
)
|
|
(58.6
|
)
|
|
(1.0
|
)
|
|
(84.1
|
)
|
||||
Balance as of December 31, 2013
|
$
|
4.4
|
|
|
$
|
19.7
|
|
|
$
|
0.5
|
|
|
$
|
24.6
|
|
(In millions)
|
2013
|
|
2012
|
||||
Revenues
|
$
|
2,104.7
|
|
|
$
|
1,378.5
|
|
Operating expenses
|
(1,344.7
|
)
|
|
(920.8
|
)
|
||
Other expenses
|
(46.6
|
)
|
|
(43.3
|
)
|
||
Income before income taxes
|
713.4
|
|
|
414.4
|
|
||
Income tax (expense) benefit
|
(289.0
|
)
|
|
335.8
|
|
||
Net income
|
$
|
424.4
|
|
|
$
|
750.2
|
|
(In millions)
|
2013
|
|
2012
|
||||
Net product sales
|
$
|
1,425.8
|
|
|
$
|
858.1
|
|
Collaboration revenue:
|
|
|
|
||||
Sanofi
|
430.1
|
|
|
423.8
|
|
||
Bayer HealthCare
|
220.3
|
|
|
70.1
|
|
||
Total collaboration revenue
|
650.4
|
|
|
493.9
|
|
||
Technology licensing and other revenue
|
28.5
|
|
|
26.5
|
|
||
Total revenue
|
$
|
2,104.7
|
|
|
$
|
1,378.5
|
|
Sanofi Collaboration Revenue
|
|
Year ended
December 31, |
||||||
(In millions)
|
|
2013
|
|
2012
|
||||
ZALTRAP:
|
|
|
|
|
||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
$
|
(30.8
|
)
|
|
$
|
(25.6
|
)
|
Substantive milestone payment
|
|
—
|
|
|
50.0
|
|
||
Reimbursement of Regeneron research and development expenses
|
|
5.6
|
|
|
10.6
|
|
||
Other
|
|
9.7
|
|
|
13.3
|
|
||
Total ZALTRAP
|
|
(15.5
|
)
|
|
48.3
|
|
||
Antibody:
|
|
|
|
|
||||
Reimbursement of Regeneron research and development expenses
|
|
453.5
|
|
|
365.3
|
|
||
Up-front payments to Sanofi for acquisition of rights related to two antibodies
|
|
(20.0
|
)
|
|
—
|
|
||
Other
|
|
12.1
|
|
|
10.2
|
|
||
Total Antibody
|
|
445.6
|
|
|
375.5
|
|
||
Total Sanofi collaboration revenue
|
|
$
|
430.1
|
|
|
$
|
423.8
|
|
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
Year ended December 31,
|
||||||
(In millions)
|
|
2013
|
|
2012
|
||||
Net product sales recorded by Sanofi
|
|
$
|
70.2
|
|
|
$
|
31.7
|
|
Regeneron's share of collaboration losses
|
|
(30.8
|
)
|
|
(25.6
|
)
|
Bayer HealthCare Collaboration Revenue
|
|
Year ended
December 31, |
||||||
(In millions)
|
|
2013
|
|
2012
|
||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
101.5
|
|
|
$
|
—
|
|
Sales and substantive development milestone payments
|
|
70.0
|
|
|
25.0
|
|
||
Cost-sharing of Regeneron EYLEA development expenses
|
|
20.9
|
|
|
34.9
|
|
||
Other
|
|
27.9
|
|
|
10.2
|
|
||
Total Bayer HealthCare collaboration revenue
|
|
$
|
220.3
|
|
|
$
|
70.1
|
|
Regeneron's Net Profit from EYLEA Sales Outside the United States
|
|
Year ended
December 31,
|
||||||
(In millions)
|
|
2013
|
|
2012
|
||||
Net product sales outside the United States
|
|
$
|
472.1
|
|
|
$
|
19.0
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
159.1
|
|
|
4.2
|
|
||
Reimbursement of EYLEA development expenses incurred by Bayer HealthCare in accordance with Regeneron's payment obligation
|
|
(57.6
|
)
|
|
(4.2
|
)
|
||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
101.5
|
|
|
$
|
—
|
|
Research and Development Expenses
|
|
Year ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2013
|
|
2012
|
|
(Decrease)
|
||||||
Payroll and benefits
(1)
|
|
$
|
294.2
|
|
|
$
|
212.1
|
|
|
$
|
82.1
|
|
Clinical trial expenses
|
|
139.5
|
|
|
92.3
|
|
|
47.2
|
|
|||
Clinical manufacturing costs
(2)
|
|
225.3
|
|
|
165.0
|
|
|
60.3
|
|
|||
Research and other development costs
|
|
73.1
|
|
|
58.0
|
|
|
15.1
|
|
|||
Occupancy and other operating costs
|
|
94.9
|
|
|
76.3
|
|
|
18.6
|
|
|||
Cost-sharing of Bayer HealthCare and Sanofi development expenses
(3)
|
|
32.9
|
|
|
21.9
|
|
|
11.0
|
|
|||
Total research and development expenses
|
|
$
|
859.9
|
|
|
$
|
625.6
|
|
|
$
|
234.3
|
|
Project Costs
|
|
Year ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2013
|
|
2012
|
|
(Decrease)
|
||||||
EYLEA
|
|
$
|
133.3
|
|
|
$
|
132.7
|
|
|
$
|
0.6
|
|
Alirocumab
|
|
152.2
|
|
|
70.1
|
|
|
82.1
|
|
|||
Sarilumab
|
|
51.9
|
|
|
27.7
|
|
|
24.2
|
|
|||
Dupilumab
|
|
89.0
|
|
|
34.9
|
|
|
54.1
|
|
|||
ARCALYST
|
|
6.4
|
|
|
38.2
|
|
|
(31.8
|
)
|
|||
Other antibody candidates in clinical development
|
|
113.9
|
|
|
101.2
|
|
|
12.7
|
|
|||
Other research programs and unallocated costs
|
|
313.2
|
|
|
220.8
|
|
|
92.4
|
|
|||
Total research and development expenses
|
|
$
|
859.9
|
|
|
$
|
625.6
|
|
|
$
|
234.3
|
|
(In millions)
|
2012
|
|
2011
|
||||
Net product sales
|
$
|
858.1
|
|
|
$
|
44.7
|
|
Collaboration revenue:
|
|
|
|
||||
Sanofi
|
423.8
|
|
|
326.6
|
|
||
Bayer HealthCare
|
70.1
|
|
|
43.1
|
|
||
Total collaboration revenue
|
493.9
|
|
|
369.7
|
|
||
Technology licensing and other revenue
|
26.5
|
|
|
31.4
|
|
||
Total revenue
|
$
|
1,378.5
|
|
|
$
|
445.8
|
|
Sanofi Collaboration Revenue
|
|
Year ended
December 31, |
||||||
(In millions)
|
|
2012
|
|
2011
|
||||
ZALTRAP:
|
|
|
|
|
||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
$
|
(25.6
|
)
|
|
$
|
(9.3
|
)
|
Substantive milestone payment
|
|
50.0
|
|
|
—
|
|
||
Reimbursement of Regeneron research and development expenses
|
|
10.6
|
|
|
16.9
|
|
||
Other
|
|
13.3
|
|
|
9.9
|
|
||
Total ZALTRAP
|
|
48.3
|
|
|
17.5
|
|
||
Antibody:
|
|
|
|
|
||||
Reimbursement of Regeneron research and development expenses
|
|
365.3
|
|
|
299.3
|
|
||
Other
|
|
10.2
|
|
|
9.8
|
|
||
Total Antibody
|
|
375.5
|
|
|
309.1
|
|
||
Total Sanofi collaboration revenue
|
|
$
|
423.8
|
|
|
$
|
326.6
|
|
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
Year ended December 31,
|
||||||
(In millions)
|
|
2012
|
|
2011
|
||||
Net product sales recorded by Sanofi
|
|
$
|
31.7
|
|
|
—
|
|
|
Regeneron's share of collaboration losses
|
|
(25.6
|
)
|
|
$
|
(9.3
|
)
|
Bayer HealthCare Collaboration Revenue
|
|
Year ended
December 31, |
||||||
(In millions)
|
|
2012
|
|
2011
|
||||
Cost-sharing of Regeneron EYLEA development expenses
|
|
$
|
34.9
|
|
|
$
|
33.7
|
|
Substantive milestone payments
|
|
25.0
|
|
|
—
|
|
||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
—
|
|
|
—
|
|
||
Other
|
|
10.2
|
|
|
9.4
|
|
||
Total Bayer HealthCare collaboration revenue
|
|
$
|
70.1
|
|
|
$
|
43.1
|
|
Regeneron's Net Profit from EYLEA Sales Outside the United States
|
|
Year ended
|
||
(In millions)
|
|
December 31, 2012
|
||
Net product sales outside the United States recorded by Bayer HealthCare
|
|
$
|
19.0
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
4.2
|
|
|
Reimbursement of EYLEA development expenses incurred by Bayer HealthCare in accordance with Regeneron's payment obligation
|
|
(4.2
|
)
|
|
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
—
|
|
Research and Development Expenses
|
|
Year ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2012
|
|
2011
|
|
(Decrease)
|
||||||
Payroll and benefits
(1)
|
|
$
|
212.1
|
|
|
$
|
168.9
|
|
|
$
|
43.2
|
|
Clinical trial expenses
|
|
92.3
|
|
|
67.6
|
|
|
24.7
|
|
|||
Clinical manufacturing costs
(2)
|
|
165.0
|
|
|
123.0
|
|
|
42.0
|
|
|||
Research and other development costs
|
|
58.0
|
|
|
60.4
|
|
|
(2.4
|
)
|
|||
Occupancy and other operating costs
|
|
76.3
|
|
|
61.8
|
|
|
14.5
|
|
|||
Cost-sharing of Bayer HealthCare EYLEA development expenses
(3)
|
|
21.9
|
|
|
47.8
|
|
|
(25.9
|
)
|
|||
Total research and development expenses
|
|
$
|
625.6
|
|
|
$
|
529.5
|
|
|
$
|
96.1
|
|
Project Costs
|
|
Year ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2012
|
|
2011
|
|
(Decrease)
|
||||||
EYLEA
|
|
$
|
132.7
|
|
|
$
|
147.6
|
|
|
$
|
(14.9
|
)
|
ARCALYST
|
|
38.2
|
|
|
43.2
|
|
|
(5.0
|
)
|
|||
ZALTRAP
|
|
13.7
|
|
|
17.1
|
|
|
(3.4
|
)
|
|||
Alirocumab
|
|
70.1
|
|
|
33.9
|
|
|
36.2
|
|
|||
Sarilumab
|
|
27.7
|
|
|
27.3
|
|
|
0.4
|
|
|||
Dupilumab
|
|
34.9
|
|
|
26.6
|
|
|
8.3
|
|
|||
Other antibody candidates in clinical development
|
|
87.5
|
|
|
48.1
|
|
|
39.4
|
|
|||
Other research programs and unallocated costs
|
|
220.8
|
|
|
185.7
|
|
|
35.1
|
|
|||
Total research and development expenses
|
|
$
|
625.6
|
|
|
$
|
529.5
|
|
|
$
|
96.1
|
|
|
|
December 31, 2013
|
|
December 31, 2012
|
||||||||||
Investment type
|
|
Fair Value
|
|
Percent
|
|
Fair Value
|
|
Percent
|
||||||
Unrestricted
|
|
|
|
|
|
|
|
|
||||||
U.S. government and government agency obligations
|
|
$
|
107.5
|
|
|
20
|
%
|
|
$
|
328.1
|
|
|
92
|
%
|
Corporate bonds
|
|
369.2
|
|
|
68
|
%
|
|
—
|
|
|
—
|
|
||
Commercial paper
|
|
24.0
|
|
|
4
|
%
|
|
—
|
|
|
—
|
|
||
Municipal bonds
|
|
36.9
|
|
|
7
|
%
|
|
17.5
|
|
|
5
|
%
|
||
International government agency obligations
|
|
2.0
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||
Certificates of deposit
|
|
7.5
|
|
|
1
|
%
|
|
—
|
|
|
—
|
|
||
Equity securities
|
|
1.2
|
|
|
—
|
|
|
3.4
|
|
|
1
|
%
|
||
Total unrestricted marketable securities
|
|
548.3
|
|
|
100
|
%
|
|
349.0
|
|
|
98
|
%
|
||
Restricted
|
|
|
|
|
|
|
|
|
||||||
U.S. government obligations
|
|
—
|
|
|
—
|
|
|
5.9
|
|
|
2
|
%
|
||
Total marketable securities
|
|
$
|
548.3
|
|
|
100
|
%
|
|
$
|
354.9
|
|
|
100
|
%
|
|
|
|
|
Payments Due by Period
|
||||||||||||||||
(In millions)
|
|
Total
|
|
Less than one year
|
|
1 to 3 years
|
|
3 to 5 years
|
|
Greater than 5 years
|
||||||||||
Convertible senior notes
(1)
|
|
$
|
422.5
|
|
|
$
|
7.5
|
|
|
$
|
415.0
|
|
|
—
|
|
|
—
|
|
||
Operating leases
(2)
|
|
117.6
|
|
|
10.9
|
|
|
19.8
|
|
|
$
|
19.0
|
|
|
$
|
67.9
|
|
|||
Purchase obligations
(3)
|
|
458.8
|
|
|
353.9
|
|
|
84.2
|
|
|
20.7
|
|
|
—
|
|
|||||
Other long-term liabilities
(4)
|
|
304.3
|
|
|
17.7
|
|
|
36.6
|
|
|
38.2
|
|
|
211.8
|
|
|||||
Total contractual obligations
|
|
$
|
1,303.2
|
|
|
$
|
390.0
|
|
|
$
|
555.6
|
|
|
$
|
77.9
|
|
|
$
|
279.7
|
|
(1)
|
Consists of $400.0 million aggregate principal amount of 1.875% convertible senior notes that mature on October 1, 2016, unless earlier converted or repurchased. The amounts in the table above assume the payment of interest on our convertible senior notes through their maturity date and the payment of the principal amount of the notes at their maturity date. Interest on the notes is payable semi-annually. The convertible senior notes will be convertible, subject to certain conditions, into cash, shares of our Common Stock, or a combination of cash and shares of Common Stock, at our option. As of
December 31, 2013
, the convertible senior notes were convertible under the terms of the indenture governing the notes.
|
(2)
|
Excludes future contingent costs for utilities, real estate taxes, and operating expenses. In 2013, these costs were
$11.5 million
. See Note 13(a) to our Consolidated Financial Statements.
|
(3)
|
Purchase obligations primarily relate to (i) research and development commitments, including those related to clinical trials, (ii) capital expenditures for equipment acquisitions, and (iii) license payments. Our obligation to pay certain of these amounts may increase or be reduced based on certain future events. Open purchase orders for the acquisition of goods and services in the ordinary course of business are excluded from the table above.
|
(4)
|
Represents payments with respect to facility lease obligations in connection with our lease of Buildings A, B, and C in Tarrytown, New York, as described under "Tarrytown, New York Leases" above. In addition to the estimated obligations in the table above, pursuant to a new lease agreement entered into in April 2013, there are two new buildings currently under construction (Buildings D and E). Rent payments on these buildings are expected to commence in
2015
, and will be based on the landlord's costs of construction and tenant allowances. See Note 13(a) to our Consolidated Financial Statements.
|
Exhibit Number
|
|
Description
|
||
3.1
|
|
(m)
|
–
|
Restated Certificate of Incorporation.
|
3.2
|
|
(a)
|
–
|
By-Laws, as amended.
|
4.1
|
|
(aa)
|
–
|
Indenture, dated as of October 21, 2011, between Regeneron Pharmaceuticals, Inc. and Wells Fargo Bank, National Association, as Trustee.
|
4.2
|
|
(aa)
|
–
|
Form of 1.875% Convertible Senior Note due October 1, 2016.
|
10.1 +
|
|
(z)
|
–
|
The Second Amended and Restated 2000 Long-Term Incentive Plan.
|
10.1.1 +
|
|
(b)
|
–
|
Form of option agreement and related notice of grant for use in connection with the grant of options to the Registrant's non-employee directors and named executive officers.
|
10.1.2 +
|
|
(b)
|
–
|
Form of option agreement and related notice of grant for use in connection with the grant of options to the Registrant's executive officers other than the named executive officers.
|
10.1.3 +
|
|
(c)
|
–
|
Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers.
|
10.1.5 +
|
|
(q)
|
–
|
Form of option agreement and related notice of grant for use in connection with the grant of time based vesting stock options to the Registrant's non-employee directors and executive officers.
|
10.1.6 +
|
|
(q)
|
–
|
Form of option agreement and related notice of grant for use in connection with the grant of performance based vesting stock options to the Registrant's executive officers.
|
10.1.7 +
|
|
(y)
|
–
|
Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers (revised).
|
10.1.8 +
|
|
(y)
|
–
|
Form of option agreement and related notice of grant for use in connection with the grant of performance based vesting stock options to the Registrant's executive officers (revised).
|
10.1.9 +
|
|
(dd)
|
–
|
Form of option agreement and related notice of grant for use in connection with the grant of time based vesting stock options to the Registrant's non-employee directors (revised)
|
10.1.10 +
|
|
|
–
|
Amendment No. 1 to the Second Amended and Restated 2000 Long-Term Incentive Plan.
|
10.2 +
|
|
(p)
|
–
|
Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S. Schleifer, M.D., Ph.D.
|
10.3* +
|
|
(d)
|
–
|
Employment Agreement, dated as of December 31, 1998, between the Registrant and P. Roy Vagelos, M.D.
|
10.4 +
|
|
(ee)
|
–
|
Offer Letter for Robert E. Landry effective September 9, 2013.
|
10.5 +
|
|
(p)
|
–
|
Regeneron Pharmaceuticals, Inc. Change in Control Severance Plan, amended and restated effective as of November 14, 2008.
|
10.6*
|
|
(e)
|
–
|
IL-1 License Agreement, dated June 26, 2002, by and among the Registrant, Immunex Corporation, and Amgen Inc.
|
10.7*
|
|
(r)
|
–
|
IL-1 Antibody Termination Agreement by and between Novartis Pharma AG, Novartis Pharmaceuticals Corporation and the Registrant, dated as of June 8, 2009.
|
10.8*
|
|
(r)
|
–
|
Trap-2 Termination Agreement by and between Novartis Pharma AG, Novartis Pharmaceuticals Corporation and the Registrant, dated as of June 8, 2009.
|
10.9*
|
|
(f)
|
–
|
Collaboration Agreement, dated as of September 5, 2003, by and between Aventis Pharmaceuticals Inc. and the Registrant.
|
10.9.1*
|
|
(d)
|
–
|
Amendment No. 1 to Collaboration Agreement, by and between Aventis Pharmaceuticals Inc. and the Registrant, effective as of December 31, 2004.
|
10.9.2
|
|
(g)
|
–
|
Amendment No. 2 to Collaboration Agreement, by and between Aventis Pharmaceuticals Inc. and the Registrant, effective as of January 7, 2005.
|
10.9.3*
|
|
(h)
|
–
|
Amendment No. 3 to Collaboration Agreement, by and between Aventis Pharmaceuticals Inc. and the Registrant, effective as of December 21, 2005.
|
10.9.4*
|
|
(h)
|
–
|
Amendment No. 4 to Collaboration Agreement, by and between sanofi-aventis U.S., LLC (successor in interest to Aventis Pharmaceuticals, Inc.) and the Registrant, effective as of January 31, 2006.
|
10.10*
|
|
(i)
|
–
|
License and Collaboration Agreement, dated as of October 18, 2006, by and between Bayer HealthCare LLC and the Registrant.
|
10.10.1*
|
|
(cc)
|
–
|
Amendment Agreement, dated as of May 7, 2012, by and between Bayer HealthCare LLC and the Registrant.
|
10.11
|
|
(j)
|
–
|
Lease, dated as of December 21, 2006, by and between BMR-Landmark at Eastview LLC and the Registrant.
|
10.11.1*
|
|
(l)
|
–
|
First Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, effective as of October 24, 2007.
|
10.11.2
|
|
(o)
|
–
|
Second Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, effective as of September 30, 2008.
|
10.11.3
|
|
(q)
|
–
|
Third Amendment to lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of April 29, 2009.
|
10.11.4
|
|
(s)
|
–
|
Fourth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, effective as of December 3, 2009.
|
10.11.5
|
|
(t)
|
–
|
Fifth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of February 11, 2010.
|
10.11.6
|
|
(w)
|
–
|
Sixth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 4, 2010.
|
10.11.7
|
|
(y)
|
–
|
Seventh Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of December 22, 2010.
|
10.11.8
|
|
(bb)
|
–
|
Eighth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of August 1, 2011.
|
10.11.9
|
|
(bb)
|
–
|
Ninth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of September 30, 2011.
|
10.11.10
|
|
(ff)
|
–
|
Eleventh Amendment to Lease by and between BMR-Landmark at Eastview LLC and Regeneron Pharmaceuticals, Inc., dated April 3, 2013.
|
10.11.11
|
|
(ff)
|
–
|
Twelfth Amendment to Lease by and between BMR-Landmark at Eastview LLC and Regeneron Pharmaceuticals, Inc., dated May 31, 2013.
|
10.11.12
|
|
(ff)
|
–
|
Thirteenth Amendment to Lease by and between BMR-Landmark at Eastview LLC and Regeneron Pharmaceuticals, Inc., dated May 31, 2013.
|
10.12
|
|
(ff)
|
–
|
Mt. Pleasant Lease by and between BMR-Landmark at Eastview LLC and Regeneron Pharmaceuticals, Inc., dated April 3, 2013.
|
10.13*
|
|
(k)
|
–
|
Non Exclusive License and Material Transfer Agreement, dated as of March 30, 2007, by and between Astellas Pharma Inc. and the Registrant.
|
10.13.1*
|
|
(x)
|
–
|
Amendment to the Non Exclusive License and Material Transfer Agreement, dated as of March 30, 2007 by and between Astellas Pharma Inc. and the Registrant, dated as of July 28, 2010.
|
10.14*
|
|
(v)
|
–
|
Amended and Restated Discovery and Preclinical Development Agreement, dated as of November 10, 2009, by and between Aventis Pharmaceuticals Inc. and the Registrant.
|
10.15*
|
|
(v)
|
–
|
Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009, by and among Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant.
|
10.15.1*
|
|
(ff)
|
–
|
First Amendment to Amended and Restated License and Collaboration Agreement by and between Regeneron Pharmaceuticals, Inc. and Aventis Pharmaceuticals Inc., dated May 1, 2013.
|
10.16
|
|
(m)
|
–
|
Stock Purchase Agreement, dated as of November 28, 2007, by and among sanofi-aventis Amerique Du Nord, sanofi-aventis US LLC, and the Registrant.
|
10.17
|
|
(m)
|
–
|
Investor Agreement, dated as of December 20, 2007, by and among sanofi-aventis, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant.
|
10.17.1
|
|
(u)
|
–
|
First Amendment to the December 20, 2007 Investor Agreement, dated as of November 10, 2009, by and among sanofi-aventis US LLC, Aventis Pharmaceuticals, Inc., sanofi-aventis Amerique du Nord, and the Registrant.
|
10.18*
|
|
(n)
|
–
|
Amended and Restated Non-Exclusive License Agreement, dated as of July 1, 2008 by and between Cellectis, S.A. and the Registrant.
|
10.19
|
|
(aa)
|
–
|
Purchase Agreement, dated as of October 18, 2011, between Regeneron Pharmaceuticals, Inc. and Goldman, Sachs & Co.
|
10.20
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated October 18, 2011, between Goldman, Sachs & Co. and Regeneron Pharmaceuticals, Inc.
|
10.21
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated October 18, 2011, between Goldman, Sachs & Co. and Regeneron Pharmaceuticals, Inc.
|
10.22
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated October 18, 2011, between Citibank, N.A. and Regeneron Pharmaceuticals, Inc.
|
10.23
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated October 18, 2011, between Citibank, N.A. and Regeneron Pharmaceuticals, Inc.
|
10.24
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated October 18, 2011, between Credit Suisse International and Regeneron Pharmaceuticals, Inc.
|
10.25
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated October 18, 2011, between Credit Suisse International and Regeneron Pharmaceuticals, Inc.
|
10.26
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated October 18, 2011, between Morgan Stanley & Co. International plc and Regeneron Pharmaceuticals, Inc.
|
10.27
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated October 18, 2011, between Morgan Stanley & Co. International plc and Regeneron Pharmaceuticals, Inc.
|
10.28*
|
|
(dd)
|
–
|
Non-exclusive License and Partial Settlement Agreement with Genentech, Inc.
|
10.28.1*
|
|
(ff)
|
–
|
Amended and Restated Non-Exclusive License and Settlement Agreement by and between Genentech, Inc. and Regeneron Pharmaceuticals, Inc., effective May 17, 2013.
|
10.28.2*
|
|
(ff)
|
–
|
Non-Exclusive License and Settlement Agreement by and between Genentech, Inc., Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. Inc. and Sanofi U.S. LLC, effective May 17, 2013.
|
10.28.3
|
|
(ff)
|
–
|
Agreement dated May 17, 2013 between Bayer Pharma AG, Bayer Australia Limited, Regeneron Pharmaceuticals, Inc., Regeneron UK Ltd and Genentech Inc.
|
10.29*
|
|
(ff)
|
–
|
Letter Agreement by and between Regeneron Pharmaceuticals, Inc. and Aventis Pharmaceuticals Inc., dated May 2, 2013.
|
21.1
|
|
|
–
|
Subsidiaries of Regeneron Pharmaceuticals, Inc.
|
23.1
|
|
|
–
|
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
|
24.1
|
|
|
–
|
Power of Attorney (included on the signature page of this Annual Report on Form 10-K).
|
31.1
|
|
|
–
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
31.2
|
|
|
–
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
32
|
|
|
–
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
|
101
|
|
|
–
|
Interactive Data File
|
101.INS
|
|
|
–
|
XBRL Instance Document
|
101.SCH
|
|
|
–
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
|
|
–
|
XBRL Taxonomy Extension Calculation Linkbase
|
101.DEF
|
|
|
–
|
XBRL Taxonomy Extension Definition Document
|
101.LAB
|
|
|
–
|
XBRL Taxonomy Extension Label Linkbase
|
101.PRE
|
|
|
–
|
XBRL Taxonomy Extension Presentation Linkbase
|
_______
|
|
|
|
|
(a)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed November 13, 2007.
|
(b)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed December 16, 2005.
|
(c)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed December 13, 2004.
|
(d)
|
|
Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2004, filed March 11, 2005.
|
(e)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended June 30, 2002, filed August 13, 2002.
|
(f)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended September 30, 2003, filed November 12, 2003.
|
(g)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed January 11, 2005.
|
(h)
|
|
Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2005, filed February 28, 2006.
|
(i)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended September 30, 2006, filed November 6, 2006.
|
(j)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed December 22, 2006.
|
(k)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended March 31, 2007, filed May 4, 2007.
|
(l)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended September 30, 2007, filed November 7, 2007.
|
(m)
|
|
Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2007, filed February 27, 2008.
|
(n)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended June 30, 2008, filed August 1, 2008.
|
(o)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended September 30, 2008, filed November 5, 2008.
|
(p)
|
|
Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2008, filed February 26, 2009.
|
(q)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended March 31, 2009, filed April 30, 2009.
|
(r)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended June 30, 2009, filed August 4, 2009.
|
(s)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed December 8, 2009.
|
(t)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed February 16, 2010.
|
(u)
|
|
Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2009, filed February 18, 2010.
|
(v)
|
|
Incorporated by reference from the Form 10-K/A for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2009, filed June 2, 2010.
|
(w)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended June 30, 2010, filed July 28, 2010.
|
(x)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended September 30, 2010, filed October 28, 2010.
|
(y)
|
|
Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2010, filed February 17, 2011.
|
(z)
|
|
Incorporated by reference from the Registration Statement on Form S-8 for Regeneron Pharmaceuticals, Inc., filed June 13, 2011.
|
(aa)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc. filed October 24, 2011.
|
(bb)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc. for the quarter ended September 30, 2011, filed October 27, 2011.
|
(cc)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc. for the quarter ended June 30, 2012, filed July 25, 2012.
|
(dd)
|
|
Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals, Inc., for the year ended December 31, 2011, filed February 21, 2012.
|
(ee)
|
|
Incorporated by reference from the Form 8-K for Regeneron Pharmaceuticals, Inc., filed September 12, 2013.
|
(ff)
|
|
Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc., for the quarter ended June 30, 2013, filed August 6, 2013.
|
|
|
|
|
|
|
*
|
|
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 13, 2014
|
|
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 13, 2014
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
/s/ ROBERT E. LANDRY
|
|
Senior Vice President, Finance and Chief Financial Officer (Principal Financial Officer)
|
|
February 13, 2014
|
Robert E. Landry
|
|
|
|
|
/s/ DOUGLAS S. McCORKLE
|
|
Vice President, Controller, and Assistant Treasurer (Principal Accounting Officer)
|
|
February 13, 2014
|
Douglas S. McCorkle
|
|
|
|
|
/s/ GEORGE D. YANCOPOULOS
|
|
Chief Scientific Officer, President, Regeneron Laboratories, and Director
|
|
February 13, 2014
|
George D. Yancopoulos, M.D., Ph.D.
|
|
|
|
|
/s/ P. ROY VAGELOS
|
|
Chairman of the Board
|
|
February 13, 2014
|
P. Roy Vagelos, M.D.
|
|
|
|
|
/s/ CHARLES A. BAKER
|
|
Director
|
|
February 13, 2014
|
Charles A. Baker
|
|
|
|
|
/s/ MICHAEL S. BROWN
|
|
Director
|
|
February 13, 2014
|
Michael S. Brown, M.D.
|
|
|
|
|
/s/ ALFRED G. GILMAN
|
|
Director
|
|
February 13, 2014
|
Alfred G. Gilman, M.D., Ph.D.
|
|
|
|
|
/s/ JOSEPH L. GOLDSTEIN
|
|
Director
|
|
February 13, 2014
|
Joseph L. Goldstein, M.D.
|
|
|
|
|
/s/ CHRISTINE A. POON
|
|
Director
|
|
February 13, 2014
|
Christine A. Poon
|
|
|
|
|
/s/ ARTHUR F. RYAN
|
|
Director
|
|
February 13, 2014
|
Arthur F. Ryan
|
|
|
|
|
/s/ ERIC M. SHOOTER
|
|
Director
|
|
February 13, 2014
|
Eric M. Shooter, Ph.D.
|
|
|
|
|
/s/ GEORGE L. SING
|
|
Director
|
|
February 13, 2014
|
George L. Sing
|
|
|
|
|
/s/ MARC TESSIER-LAVIGNE
|
|
Director
|
|
February 13, 2014
|
Marc Tessier-Lavigne, Ph.D.
|
|
|
|
|
|
|
Page Numbers
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
535,608
|
|
|
$
|
230,276
|
|
Marketable securities
|
158,376
|
|
|
77,819
|
|
||
Accounts receivable - trade, net
|
787,071
|
|
|
593,207
|
|
||
Accounts receivable from Sanofi
|
104,707
|
|
|
99,913
|
|
||
Inventories
|
70,354
|
|
|
28,638
|
|
||
Deferred tax assets
|
44,677
|
|
|
148,134
|
|
||
Prepaid expenses and other current assets
|
96,141
|
|
|
28,025
|
|
||
Total current assets
|
1,796,934
|
|
|
1,206,012
|
|
||
|
|
|
|
||||
Restricted cash and marketable securities
|
—
|
|
|
8,186
|
|
||
Marketable securities
|
389,891
|
|
|
271,230
|
|
||
Property, plant, and equipment, at cost, net of accumulated depreciation and amortization
|
526,983
|
|
|
379,940
|
|
||
Deferred tax assets
|
231,878
|
|
|
192,022
|
|
||
Other assets
|
5,327
|
|
|
23,100
|
|
||
Total assets
|
$
|
2,951,013
|
|
|
$
|
2,080,490
|
|
|
|
|
|
||||
LIABILITIES and STOCKHOLDERS' EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
250,896
|
|
|
$
|
111,345
|
|
Deferred revenue from Sanofi, current portion
|
12,815
|
|
|
17,022
|
|
||
Deferred revenue - other, current portion
|
34,185
|
|
|
33,809
|
|
||
Facility lease obligations, current portion
|
939
|
|
|
1,374
|
|
||
Total current liabilities
|
298,835
|
|
|
163,550
|
|
||
|
|
|
|
||||
Deferred revenue from Sanofi
|
76,522
|
|
|
76,520
|
|
||
Deferred revenue - other
|
107,677
|
|
|
131,822
|
|
||
Facility lease obligations
|
184,258
|
|
|
159,436
|
|
||
Convertible senior notes
|
320,315
|
|
|
296,518
|
|
||
Other long-term liabilities
|
11,330
|
|
|
7,259
|
|
||
Total liabilities
|
998,937
|
|
|
835,105
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 13)
|
|
|
|
|
|
||
|
|
|
|
||||
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 - 2,020,481 at December 31, 2013 and 2,069,187 at December 31, 2012
|
2
|
|
|
2
|
|
||
Common Stock, $.001 par value; 160,000,000 shares authorized; shares issued and outstanding - 97,666,814 at December 31, 2013 and 95,223,525 at December 31, 2012
|
97
|
|
|
95
|
|
||
Additional paid-in capital
|
2,045,857
|
|
|
1,763,508
|
|
||
Accumulated deficit
|
(92,692
|
)
|
|
(517,054
|
)
|
||
Accumulated other comprehensive loss
|
(1,188
|
)
|
|
(1,166
|
)
|
||
Total stockholders' equity
|
1,952,076
|
|
|
1,245,385
|
|
||
Total liabilities and stockholders' equity
|
$
|
2,951,013
|
|
|
$
|
2,080,490
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Statements of Operations
|
|
|
|
|
|
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Net product sales
|
|
$
|
1,425,839
|
|
|
$
|
858,093
|
|
|
$
|
44,686
|
|
Sanofi collaboration revenue
|
|
430,111
|
|
|
423,814
|
|
|
326,609
|
|
|||
Bayer HealthCare collaboration revenue
|
|
220,289
|
|
|
70,099
|
|
|
43,072
|
|
|||
Technology licensing and other revenue
|
|
28,506
|
|
|
26,471
|
|
|
31,457
|
|
|||
|
|
2,104,745
|
|
|
1,378,477
|
|
|
445,824
|
|
|||
|
|
|
|
|
|
|
||||||
Expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
859,947
|
|
|
625,554
|
|
|
529,506
|
|
|||
Selling, general, and administrative
|
|
329,415
|
|
|
210,755
|
|
|
117,261
|
|
|||
Cost of goods sold
|
|
118,048
|
|
|
83,927
|
|
|
4,216
|
|
|||
Cost of collaboration manufacturing
|
|
37,307
|
|
|
528
|
|
|
—
|
|
|||
|
|
1,344,717
|
|
|
920,764
|
|
|
650,983
|
|
|||
|
|
|
|
|
|
|
||||||
Income (loss) from operations
|
|
760,028
|
|
|
457,713
|
|
|
(205,159
|
)
|
|||
|
|
|
|
|
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
||||||
Investment (expense) income
|
|
(231
|
)
|
|
2,012
|
|
|
3,549
|
|
|||
Interest expense
|
|
(46,437
|
)
|
|
(45,304
|
)
|
|
(21,282
|
)
|
|||
|
|
(46,668
|
)
|
|
(43,292
|
)
|
|
(17,733
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income (loss) before income taxes
|
|
713,360
|
|
|
414,421
|
|
|
(222,892
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income tax (expense) benefit
|
|
(288,998
|
)
|
|
335,848
|
|
|
1,132
|
|
|||
|
|
|
|
|
|
|
||||||
Net income (loss)
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
|
$
|
(221,760
|
)
|
|
|
|
|
|
|
|
||||||
Net income (loss) per share - basic
|
|
$
|
4.33
|
|
|
$
|
7.92
|
|
|
$
|
(2.45
|
)
|
Net income (loss) per share - diluted
|
|
$
|
3.81
|
|
|
$
|
6.75
|
|
|
$
|
(2.45
|
)
|
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
|
97,917
|
|
|
94,685
|
|
|
90,610
|
|
|||
Weighted average shares outstanding - diluted
|
|
111,290
|
|
|
115,382
|
|
|
90,610
|
|
|||
|
|
|
|
|
|
|
||||||
Statements of Comprehensive Income (Loss)
|
|
|
|
|
|
|
||||||
Net income (loss)
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
|
$
|
(221,760
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
||||||
Unrealized (loss) gain on marketable securities, net of tax
|
|
(22
|
)
|
|
696
|
|
|
629
|
|
|||
Comprehensive income (loss)
|
|
$
|
424,340
|
|
|
$
|
750,965
|
|
|
$
|
(221,131
|
)
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Class A Stock
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholders' Equity
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
Balance, December 31, 2010
|
|
2,182
|
|
|
$
|
2
|
|
|
87,238
|
|
|
$
|
87
|
|
|
$
|
1,575,780
|
|
|
$
|
(1,045,563
|
)
|
|
$
|
(2,491
|
)
|
|
$
|
527,815
|
|
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
3,770
|
|
|
4
|
|
|
43,611
|
|
|
—
|
|
|
—
|
|
|
43,615
|
|
||||||
Common Stock tendered upon exercise of stock options in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(446
|
)
|
|
—
|
|
|
(22,440
|
)
|
|
—
|
|
|
—
|
|
|
(22,440
|
)
|
||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
|
|
—
|
|
|
—
|
|
|
92
|
|
|
—
|
|
|
6,979
|
|
|
—
|
|
|
—
|
|
|
6,979
|
|
||||||
Issuance of restricted Common Stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
16
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Restricted Common Stock tendered upon vesting in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(51
|
)
|
|
—
|
|
|
(2,638
|
)
|
|
—
|
|
|
—
|
|
|
(2,638
|
)
|
||||||
Conversion of Class A Stock to Common Stock
|
|
(73
|
)
|
|
—
|
|
|
73
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
56,609
|
|
|
—
|
|
|
—
|
|
|
56,609
|
|
||||||
Equity component of convertible senior notes, net of issuance costs
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
120,623
|
|
|
—
|
|
|
—
|
|
|
120,623
|
|
||||||
Purchase of convertible note hedges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(117,500
|
)
|
|
—
|
|
|
—
|
|
|
(117,500
|
)
|
||||||
Issuance of warrants in connection with issuance of convertible senior notes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
93,800
|
|
|
—
|
|
|
—
|
|
|
93,800
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(221,760
|
)
|
|
—
|
|
|
(221,760
|
)
|
||||||
Other comprehensive income, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
629
|
|
|
629
|
|
||||||
Balance, December 31, 2011
|
|
2,109
|
|
|
2
|
|
|
90,692
|
|
|
91
|
|
|
1,754,824
|
|
|
(1,267,323
|
)
|
|
(1,862
|
)
|
|
485,732
|
|
||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
5,086
|
|
|
5
|
|
|
67,169
|
|
|
—
|
|
|
—
|
|
|
67,174
|
|
||||||
Common Stock tendered upon exercise of stock options in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(878
|
)
|
|
(1
|
)
|
|
(112,833
|
)
|
|
—
|
|
|
—
|
|
|
(112,834
|
)
|
||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
|
|
—
|
|
|
—
|
|
|
64
|
|
|
—
|
|
|
6,325
|
|
|
—
|
|
|
—
|
|
|
6,325
|
|
||||||
Issuance of restricted Common Stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
501
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Restricted Common Stock tendered upon vesting in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(282
|
)
|
|
—
|
|
|
(50,466
|
)
|
|
—
|
|
|
—
|
|
|
(50,466
|
)
|
||||||
Conversion of Class A Stock to Common Stock
|
|
(40
|
)
|
|
—
|
|
|
40
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
94,181
|
|
|
—
|
|
|
—
|
|
|
94,181
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||||||
Net income (loss)
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
|
$
|
(221,760
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
41,204
|
|
|
36,940
|
|
|
31,082
|
|
|||
Non-cash compensation expense
|
|
198,399
|
|
|
94,157
|
|
|
56,094
|
|
|||
Non-cash interest expense
|
|
23,061
|
|
|
22,925
|
|
|
5,101
|
|
|||
Other non-cash charges and expenses, net
|
|
23,690
|
|
|
34,049
|
|
|
6,714
|
|
|||
Deferred taxes
|
|
63,601
|
|
|
(340,156
|
)
|
|
—
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Increase in Sanofi and trade accounts receivable
|
|
(198,658
|
)
|
|
(590,085
|
)
|
|
(21,118
|
)
|
|||
Increase in inventories
|
|
(47,956
|
)
|
|
(28,932
|
)
|
|
(14,094
|
)
|
|||
(Increase) decrease in prepaid expenses and other assets
|
|
(52,765
|
)
|
|
(23,684
|
)
|
|
6,612
|
|
|||
Decrease in deferred revenue
|
|
(27,974
|
)
|
|
(41,077
|
)
|
|
(40,329
|
)
|
|||
Increase in accounts payable, accrued expenses, and other liabilities
|
|
136,684
|
|
|
10,979
|
|
|
50,016
|
|
|||
Total adjustments
|
|
159,286
|
|
|
(824,884
|
)
|
|
80,078
|
|
|||
Net cash provided by (used in) operating activities
|
|
583,648
|
|
|
(74,615
|
)
|
|
(141,682
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
|
(577,278
|
)
|
|
(470,393
|
)
|
|
(240,391
|
)
|
|||
Sales or maturities of marketable securities
|
|
378,146
|
|
|
439,209
|
|
|
426,356
|
|
|||
Purchase of restricted cash and marketable securities
|
|
—
|
|
|
(552
|
)
|
|
(277
|
)
|
|||
Capital expenditures
|
|
(156,323
|
)
|
|
(49,337
|
)
|
|
(57,217
|
)
|
|||
Net cash (used in) provided by investing activities
|
|
(355,455
|
)
|
|
(81,073
|
)
|
|
128,471
|
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||||||
Payments in connection with facility and capital lease obligations
|
|
(2,024
|
)
|
|
(2,203
|
)
|
|
(1,667
|
)
|
|||
Proceeds from issuance of Common Stock
|
|
57,393
|
|
|
63,549
|
|
|
43,587
|
|
|||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(195,087
|
)
|
|
(163,300
|
)
|
|
(25,078
|
)
|
|||
Excess tax benefit from stock-based compensation
|
|
216,857
|
|
|
4,308
|
|
|
—
|
|
|||
Proceeds in connection with issuance of convertible notes, net of debt issuance costs
|
|
—
|
|
|
—
|
|
|
391,107
|
|
|||
Proceeds in connection with issuance of warrants
|
|
—
|
|
|
—
|
|
|
93,800
|
|
|||
Payment in connection with purchase of convertible note hedges
|
|
—
|
|
|
—
|
|
|
(117,500
|
)
|
|||
Net cash provided by (used in) financing activities
|
|
77,139
|
|
|
(97,646
|
)
|
|
384,249
|
|
|||
|
|
|
|
|
|
|
||||||
Net increase (decrease) in cash and cash equivalents
|
|
305,332
|
|
|
(253,334
|
)
|
|
371,038
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at beginning of period
|
|
230,276
|
|
|
483,610
|
|
|
112,572
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at end of period
|
|
$
|
535,608
|
|
|
$
|
230,276
|
|
|
$
|
483,610
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest
|
|
$
|
23,842
|
|
|
$
|
21,946
|
|
|
$
|
14,725
|
|
The accompanying notes are an integral part of the financial statements
|
•
|
EYLEA
®
(aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, which is available in the United States, European Union ("EU"), Japan and certain other countries outside the United States for the treatment of neovascular age-related macular degeneration ("wet AMD") and macular edema following central retinal vein occlusion ("CRVO"). The Company commenced sales of EYLEA for the treatment of wet AMD in November 2011 and for the treatment of macular edema following CRVO in September 2012, following receipt of regulatory approvals in the United States. Bayer HealthCare LLC commenced sales of EYLEA for the treatment of wet AMD in the fourth quarter of 2012 following receipt of regulatory approvals outside the United States, and for the treatment of macular edema secondary to CRVO in the fourth quarter of 2013 following receipt of regulatory approvals in the EU and Japan. Regeneron is collaborating with Bayer HealthCare on the global development and commercialization of EYLEA outside the United States. Regeneron maintains exclusive rights to EYLEA in the United States and is entitled to all profits from any such sales.
|
•
|
ZALTRAP
®
(ziv-aflibercept) Injection for Intravenous Infusion, known in the scientific literature as VEGF Trap, which is available in the United States, European Union, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan ("FOLFIRI"), for patients with metastatic colorectal cancer ("mCRC") that is resistant to or has progressed following an oxaliplatin-containing regimen. Marketing approval for ZALTRAP was received from the U.S. Food and Drug Administration ("FDA") in August 2012, and from the European Commission in February 2013. Regeneron and Sanofi globally collaborate on the development and commercialization of ZALTRAP.
|
•
|
ARCALYST
®
(rilonacept) Injection for Subcutaneous Use, which is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes ("CAPS"), including Familial Cold Auto-inflammatory Syndrome ("FCAS") and Muckle-Wells Syndrome ("MWS"), in adults and children 12 and older. Marketing approval for ARCALYST for the treatment of CAPS was received from the FDA in 2008.
|
Building and improvements
|
|
10-35 years
|
Laboratory and other equipment
|
|
3-10 years
|
Furniture and fixtures
|
|
5 years
|
•
|
Included in Sanofi collaboration revenue is the Company's share of profits or losses from commercialization of ZALTRAP,
|
•
|
Included in Bayer HealthCare collaboration revenue is the Company's share of profits or losses from commercialization of EYLEA outside the United States, which is provided by Bayer HealthCare, and includes an estimate of the Company's share of profits or losses for the most recent fiscal quarter.
|
•
|
Included in research and development expenses is the Company's share of development expenses incurred by its collaboration partners, Bayer HealthCare and Sanofi, including the Company's share of Bayer HealthCare and Sanofi estimated development expenses for the most recent fiscal quarter.
|
|
Rebates &
Chargebacks
|
|
Distribution-
Related
Fees
|
|
Other Sales-
Related
Deductions
|
|
Total
|
||||||||
Balance as of December 31, 2011
|
$
|
585
|
|
|
$
|
1,451
|
|
|
$
|
182
|
|
|
$
|
2,218
|
|
Provision related to current period sales
|
14,153
|
|
|
45,028
|
|
|
3,070
|
|
|
62,251
|
|
||||
Credits/payments
|
(11,755
|
)
|
|
(31,181
|
)
|
|
(2,707
|
)
|
|
(45,643
|
)
|
||||
Balance as of December 31, 2012
|
2,983
|
|
|
15,298
|
|
|
545
|
|
|
18,826
|
|
||||
Provision related to current period sales
|
25,936
|
|
|
62,984
|
|
|
955
|
|
|
89,875
|
|
||||
Credits/payments
|
(24,519
|
)
|
|
(58,619
|
)
|
|
(962
|
)
|
|
(84,100
|
)
|
||||
Balance as of December 31, 2013
|
$
|
4,400
|
|
|
$
|
19,663
|
|
|
$
|
538
|
|
|
$
|
24,601
|
|
|
|
Year ended December 31,
|
||||||||||
Sanofi Collaboration Revenue - ZALTRAP
|
|
2013
|
|
2012
|
|
2011
|
||||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
$
|
(30,810
|
)
|
|
$
|
(25,634
|
)
|
|
$
|
(9,321
|
)
|
Substantive milestone payment
|
|
—
|
|
|
50,000
|
|
|
—
|
|
|||
Reimbursement of Regeneron research and development expenses
|
|
5,639
|
|
|
10,702
|
|
|
16,871
|
|
|||
Other
|
|
9,682
|
|
|
13,268
|
|
|
9,932
|
|
|||
|
|
$
|
(15,489
|
)
|
|
$
|
48,336
|
|
|
$
|
17,482
|
|
|
|
Year ended December 31,
|
||||||||||
Sanofi Collaboration Revenue - Antibody
|
|
2013
|
|
2012
|
|
2011
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
453,489
|
|
|
$
|
365,245
|
|
|
$
|
299,281
|
|
Up-front payments to Sanofi for acquisition of rights related to two antibodies
|
|
(20,000
|
)
|
|
—
|
|
|
—
|
|
|||
Other
|
|
12,111
|
|
|
10,233
|
|
|
9,846
|
|
|||
|
|
$
|
445,600
|
|
|
$
|
375,478
|
|
|
$
|
309,127
|
|
|
|
Year ended December 31,
|
||||||||||
Bayer HealthCare Collaboration Revenue
|
|
2013
|
|
2012
|
|
2011
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
101,494
|
|
|
—
|
|
|
—
|
|
||
Sales and substantive development milestone payments
|
|
70,000
|
|
|
$
|
25,000
|
|
|
—
|
|
||
Cost-sharing of Regeneron EYLEA development expenses
|
|
20,905
|
|
|
34,892
|
|
|
$
|
33,682
|
|
||
Other
|
|
27,890
|
|
|
10,207
|
|
|
9,390
|
|
|||
|
|
$
|
220,289
|
|
|
$
|
70,099
|
|
|
$
|
43,072
|
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
At December 31, 2013
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
||||||||
U.S. government and government agency obligations
|
|
$
|
107,493
|
|
|
$
|
55
|
|
|
$
|
(27
|
)
|
|
$
|
107,521
|
|
Corporate bonds
|
|
369,321
|
|
|
233
|
|
|
(361
|
)
|
|
369,193
|
|
||||
Commercial paper
|
|
23,891
|
|
|
53
|
|
|
—
|
|
|
23,944
|
|
||||
Municipal bonds
|
|
36,935
|
|
|
45
|
|
|
(59
|
)
|
|
36,921
|
|
||||
International government agency obligations
|
|
2,007
|
|
|
1
|
|
|
—
|
|
|
2,008
|
|
||||
Certificates of deposit
|
|
7,509
|
|
|
5
|
|
|
—
|
|
|
7,514
|
|
||||
Equity securities
|
|
1,166
|
|
|
—
|
|
|
—
|
|
|
1,166
|
|
||||
|
|
$
|
548,322
|
|
|
$
|
392
|
|
|
$
|
(447
|
)
|
|
$
|
548,267
|
|
At December 31, 2012
|
|
|
|
|
|
|
|
|
||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
||||||||
U.S. government and government agency obligations
|
|
$
|
327,502
|
|
|
$
|
661
|
|
|
$
|
(17
|
)
|
|
$
|
328,146
|
|
Municipal bonds
|
|
17,542
|
|
|
—
|
|
|
(32
|
)
|
|
17,510
|
|
||||
Equity securities
|
|
4,044
|
|
|
—
|
|
|
(651
|
)
|
|
3,393
|
|
||||
|
|
349,088
|
|
|
661
|
|
|
(700
|
)
|
|
349,049
|
|
||||
Restricted
|
|
|
|
|
|
|
|
|
||||||||
U.S. government obligations
|
|
5,902
|
|
|
9
|
|
|
(2
|
)
|
|
5,909
|
|
||||
|
|
$
|
354,990
|
|
|
$
|
670
|
|
|
$
|
(702
|
)
|
|
$
|
354,958
|
|
|
|
2013
|
|
2012
|
||||
Unrestricted
|
|
|
|
|
||||
Maturities within one year
|
|
$
|
158,376
|
|
|
$
|
77,819
|
|
Maturities after one year through five years
|
|
383,410
|
|
|
267,837
|
|
||
Maturities after five years through ten years
|
|
4,138
|
|
|
—
|
|
||
Maturities after ten years
|
|
1,177
|
|
|
—
|
|
||
|
|
547,101
|
|
|
345,656
|
|
||
Restricted
|
|
|
|
|
||||
Maturities within one year
|
|
—
|
|
|
2,781
|
|
||
Maturities after one year through five years
|
|
—
|
|
|
3,128
|
|
||
|
|
—
|
|
|
5,909
|
|
||
|
|
$
|
547,101
|
|
|
$
|
351,565
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
At December 31, 2013
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
U.S. government and government agency obligations
|
$
|
49,241
|
|
|
$
|
(27
|
)
|
|
—
|
|
|
—
|
|
|
$
|
49,241
|
|
|
$
|
(27
|
)
|
||
Corporate bonds
|
176,140
|
|
|
(361
|
)
|
|
—
|
|
|
—
|
|
|
176,140
|
|
|
(361
|
)
|
||||||
Municipal bonds
|
14,431
|
|
|
(59
|
)
|
|
—
|
|
|
—
|
|
|
14,431
|
|
|
(59
|
)
|
||||||
|
$
|
239,812
|
|
|
$
|
(447
|
)
|
|
—
|
|
|
—
|
|
|
$
|
239,812
|
|
|
$
|
(447
|
)
|
||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
At December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
U.S. government and government agency obligations
|
$
|
44,738
|
|
|
$
|
(17
|
)
|
|
—
|
|
|
—
|
|
|
$
|
44,738
|
|
|
$
|
(17
|
)
|
||
Municipal bonds
|
17,510
|
|
|
(32
|
)
|
|
—
|
|
|
—
|
|
|
17,510
|
|
|
(32
|
)
|
||||||
Equity securities
|
—
|
|
|
—
|
|
|
$
|
3,393
|
|
|
$
|
(651
|
)
|
|
3,393
|
|
|
(651
|
)
|
||||
|
62,248
|
|
|
(49
|
)
|
|
3,393
|
|
|
(651
|
)
|
|
65,641
|
|
|
(700
|
)
|
||||||
Restricted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
U.S government obligations
|
1,194
|
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
1,194
|
|
|
(2
|
)
|
||||||
|
$
|
63,442
|
|
|
$
|
(51
|
)
|
|
$
|
3,393
|
|
|
$
|
(651
|
)
|
|
$
|
66,835
|
|
|
$
|
(702
|
)
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||
At December 31, 2013
|
Fair Value
|
|
Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
||||||
Unrestricted
|
|
|
|
|
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
U.S. government and government agency obligations
|
$
|
107,521
|
|
|
—
|
|
|
$
|
107,521
|
|
|
Corporate bonds
|
369,193
|
|
|
—
|
|
|
369,193
|
|
|||
Commercial paper
|
23,944
|
|
|
—
|
|
|
23,944
|
|
|||
Municipal bonds
|
36,921
|
|
|
—
|
|
|
36,921
|
|
|||
International government agency obligations
|
2,008
|
|
|
—
|
|
|
2,008
|
|
|||
Certificates of deposit
|
7,514
|
|
|
—
|
|
|
7,514
|
|
|||
Equity securities
|
1,166
|
|
|
$
|
1,166
|
|
|
—
|
|
||
|
$
|
548,267
|
|
|
$
|
1,166
|
|
|
$
|
547,101
|
|
|
|
|
|
|
|
||||||
At December 31, 2012
|
|
|
|
|
|
||||||
Unrestricted
|
|
|
|
|
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
U.S. government and government agency obligations
|
$
|
328,146
|
|
|
—
|
|
|
$
|
328,146
|
|
|
Municipal bonds
|
17,510
|
|
|
—
|
|
|
17,510
|
|
|||
Equity securities
|
3,393
|
|
|
$
|
3,393
|
|
|
—
|
|
||
|
349,049
|
|
|
3,393
|
|
|
345,656
|
|
|||
Restricted
|
|
|
|
|
|
|
|||||
Available-for-sale marketable securities:
|
|
|
|
|
|
|
|||||
U.S. government obligations
|
5,909
|
|
|
—
|
|
|
5,909
|
|
|||
|
$
|
354,958
|
|
|
$
|
3,393
|
|
|
$
|
351,565
|
|
|
As of December 31,
|
||||||
|
2013
|
|
2012
|
||||
Land
|
$
|
2,768
|
|
|
$
|
2,117
|
|
Building and improvements
|
343,363
|
|
|
328,173
|
|
||
Leasehold improvements
|
26,370
|
|
|
10,576
|
|
||
Construction-in-progress
|
142,370
|
|
|
25,076
|
|
||
Laboratory and other equipment
|
189,543
|
|
|
159,026
|
|
||
Furniture, computer and office equipment, and other
|
44,186
|
|
|
35,485
|
|
||
|
748,600
|
|
|
560,453
|
|
||
Less, accumulated depreciation and amortization
|
(221,617
|
)
|
|
(180,513
|
)
|
||
|
$
|
526,983
|
|
|
$
|
379,940
|
|
|
As of December 31,
|
||||||
|
2013
|
|
2012
|
||||
Accounts payable
|
$
|
61,936
|
|
|
$
|
38,934
|
|
Accrued payroll and related costs
|
69,429
|
|
|
19,987
|
|
||
Accrued clinical trial expense
|
23,654
|
|
|
10,985
|
|
||
Accrued sales-related charges, deductions, and royalties
|
66,855
|
|
|
21,870
|
|
||
Other accrued expenses and liabilities
|
29,022
|
|
|
19,569
|
|
||
|
$
|
250,896
|
|
|
$
|
111,345
|
|
|
As of December 31,
|
||||||
|
2013
|
|
2012
|
||||
Current portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 4a)
|
$
|
12,815
|
|
|
$
|
17,022
|
|
Received or receivable from Bayer HealthCare (see Note 4b)
|
9,738
|
|
|
9,212
|
|
||
Received for technology license agreement (see Note 5)
|
23,572
|
|
|
23,572
|
|
||
Other
|
875
|
|
|
1,025
|
|
||
|
$
|
47,000
|
|
|
$
|
50,831
|
|
Long-term portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 4a)
|
$
|
76,522
|
|
|
$
|
76,520
|
|
Received or receivable from Bayer HealthCare (see Note 4b)
|
26,683
|
|
|
27,256
|
|
||
Received for technology license agreement (see Note 5)
|
80,994
|
|
|
104,566
|
|
||
|
$
|
184,199
|
|
|
$
|
208,342
|
|
|
|
As of December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Total convertible senior notes - par
|
|
$
|
400,000
|
|
|
$
|
400,000
|
|
Unamortized discount
|
|
(79,685
|
)
|
|
(103,482
|
)
|
||
|
|
$
|
320,315
|
|
|
$
|
296,518
|
|
|
|
2013
|
|
2012
|
|
2011
|
||||||
Contractual coupon interest rate
|
|
$
|
7,230
|
|
|
$
|
7,503
|
|
|
$
|
1,455
|
|
Amortization of discount and note issuance costs
|
|
22,980
|
|
|
21,623
|
|
|
3,944
|
|
|||
|
|
$
|
30,210
|
|
|
$
|
29,126
|
|
|
$
|
5,399
|
|
December 31,
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2014
|
|
$
|
8,765
|
|
|
$
|
2,169
|
|
|
$
|
10,934
|
|
2015
|
|
9,348
|
|
|
505
|
|
|
9,853
|
|
|||
2016
|
|
9,895
|
|
|
24
|
|
|
9,919
|
|
|||
2017
|
|
9,429
|
|
|
—
|
|
|
9,429
|
|
|||
2018
|
|
9,606
|
|
|
—
|
|
|
9,606
|
|
|||
Thereafter
|
|
67,849
|
|
|
—
|
|
|
67,849
|
|
|||
|
|
$
|
114,892
|
|
|
$
|
2,698
|
|
|
$
|
117,590
|
|
Year Ended December 31,
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2013
|
|
$
|
9,404
|
|
|
$
|
471
|
|
|
$
|
9,875
|
|
2012
|
|
7,428
|
|
|
601
|
|
|
8,029
|
|
|||
2011
|
|
7,191
|
|
|
599
|
|
|
7,790
|
|
December 31,
|
|
Buildings A and B
|
|
Building C
|
|
Total
|
||||||
2014
|
|
$
|
13,288
|
|
|
$
|
4,438
|
|
|
$
|
17,726
|
|
2015
|
|
13,545
|
|
|
4,562
|
|
|
18,107
|
|
|||
2016
|
|
13,809
|
|
|
4,689
|
|
|
18,498
|
|
|||
2017
|
|
14,079
|
|
|
4,818
|
|
|
18,897
|
|
|||
2018
|
|
14,356
|
|
|
4,951
|
|
|
19,307
|
|
|||
Thereafter
|
|
146,667
|
|
|
65,074
|
|
|
211,741
|
|
|||
|
|
$
|
215,744
|
|
|
$
|
88,532
|
|
|
$
|
304,276
|
|
a.
|
Stock Options
|
Stock Options:
|
|
Number of Shares
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term (in years)
|
|
Intrinsic Value (in thousands)
|
||||||
Outstanding at December 31, 2012
|
|
20,789,511
|
|
|
$
|
56.03
|
|
|
|
|
|
|||
2013:
|
Granted
|
|
3,937,989
|
|
|
$
|
263.77
|
|
|
|
|
|
||
|
Forfeited
|
|
(141,199
|
)
|
|
$
|
105.71
|
|
|
|
|
|
||
|
Expired
|
|
(1,521
|
)
|
|
$
|
21.46
|
|
|
|
|
|
||
|
Exercised
|
|
(3,176,512
|
)
|
|
$
|
27.82
|
|
|
|
|
|
||
|
Outstanding at December 31, 2013
|
|
21,408,268
|
|
|
$
|
98.10
|
|
|
7.01
|
|
$
|
3,811,441
|
|
Vested and expected to vest at December 31, 2013
|
|
20,875,388
|
|
|
$
|
95.63
|
|
|
6.96
|
|
$
|
3,768,120
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable at December 31, 2013
|
|
11,322,801
|
|
|
$
|
36.83
|
|
|
5.37
|
|
$
|
2,709,278
|
|
|
|
Number of Options Granted
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Fair Value
|
|||||
2013:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
3,937,989
|
|
|
$
|
263.77
|
|
|
$
|
104.90
|
|
2012:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
4,162,653
|
|
|
$
|
167.96
|
|
|
$
|
67.66
|
|
2011:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
4,286,640
|
|
|
$
|
51.96
|
|
|
$
|
23.82
|
|
|
|
2013
|
|
2012
|
|
2011
|
|||
Expected volatility
|
|
42
|
%
|
|
45
|
%
|
|
48
|
%
|
Expected lives from grant date
|
|
5.3 years
|
|
|
5.4 years
|
|
|
6.1 years
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk-free interest rate
|
|
1.73
|
%
|
|
0.86
|
%
|
|
1.31
|
%
|
b.
|
Restricted Stock
|
Restricted Stock:
|
Number of Shares
|
|
Weighted-Average Grant Date Fair Value
|
|||||
Outstanding at December 31, 2012
|
|
642,499
|
|
|
$
|
96.68
|
|
|
2013:
|
Granted
|
|
6,080
|
|
|
$
|
272.70
|
|
|
Vested
|
|
(109,999
|
)
|
|
$
|
30.63
|
|
|
Outstanding at December 31, 2013
|
|
538,580
|
|
|
$
|
112.16
|
|
|
|
2013
|
|
2012
|
||||
Current:
|
|
|
|
|||||
|
Federal
|
$
|
201,475
|
|
|
—
|
|
|
|
State
|
23,489
|
|
|
$
|
4,308
|
|
|
|
Foreign
|
433
|
|
|
—
|
|
||
|
Total current tax expense (benefit)
|
225,397
|
|
|
4,308
|
|
||
Deferred:
|
|
|
|
|||||
|
Federal
|
54,910
|
|
|
(300,319
|
)
|
||
|
State
|
8,700
|
|
|
(39,837
|
)
|
||
|
Foreign
|
(9
|
)
|
|
—
|
|
||
|
Total deferred tax expense (benefit)
|
63,601
|
|
|
(340,156
|
)
|
||
Total income tax expense (benefit)
|
$
|
288,998
|
|
|
$
|
(335,848
|
)
|
|
2013
|
|
2012
|
||
U.S. federal statutory tax rate
|
35.0
|
%
|
|
35.0
|
%
|
State and local income taxes
|
3.4
|
|
|
5.4
|
|
Change in state effective rate
|
—
|
|
|
5.4
|
|
Other non-deductible and permanent differences
|
2.1
|
|
|
2.8
|
|
Foreign income tax rate differential
|
4.9
|
|
|
—
|
|
Income tax credits
|
(4.9
|
)
|
|
—
|
|
Reclassification of net operating losses related to exercises of stock options
|
—
|
|
|
9.3
|
|
Provision (benefit) attributable to valuation allowances
|
—
|
|
|
(139.0
|
)
|
Effective income tax rate
|
40.5
|
%
|
|
(81.1
|
)%
|
|
|
As of December 31,
|
||||||
|
|
2013
|
|
2012
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating loss carry-forward
|
|
$
|
135
|
|
|
$
|
77,119
|
|
Fixed assets
|
|
18,902
|
|
|
1,380
|
|
||
Deferred revenue
|
|
88,033
|
|
|
99,659
|
|
||
Deferred compensation
|
|
109,715
|
|
|
53,367
|
|
||
Income tax credit carry-forwards
|
|
9,372
|
|
|
71,164
|
|
||
Capitalized research and development costs
|
|
18,942
|
|
|
24,437
|
|
||
Other
|
|
34,215
|
|
|
23,511
|
|
||
|
|
279,314
|
|
|
350,637
|
|
||
Valuation allowance
|
|
(1,830
|
)
|
|
(2,486
|
)
|
||
Total deferred tax assets
|
|
277,484
|
|
|
348,151
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
||||
Accruals
|
|
—
|
|
|
(6,824
|
)
|
||
Convertible senior notes
|
|
(929
|
)
|
|
(1,171
|
)
|
||
|
|
(929
|
)
|
|
(7,995
|
)
|
||
|
|
|
|
|
||||
Net deferred tax assets
|
|
$
|
276,555
|
|
|
$
|
340,156
|
|
|
|
2013
|
|
2012
|
|
2011
|
||||||
Balance as of January 1
|
|
$
|
11,274
|
|
|
$
|
5,596
|
|
|
$
|
12,819
|
|
Gross increases related to current year tax positions
|
|
7,620
|
|
|
1,873
|
|
|
2,192
|
|
|||
Gross increases related to prior year tax positions
|
|
8,305
|
|
|
3,805
|
|
|
—
|
|
|||
Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation
|
|
(572
|
)
|
|
—
|
|
|
(9,415
|
)
|
|||
Balance as of December 31
|
|
$
|
26,627
|
|
|
$
|
11,274
|
|
|
$
|
5,596
|
|
|
|
December 31,
|
||||||||||
|
|
2013
|
|
2012
|
|
2011
|
||||||
Net income (loss) - basic
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
|
$
|
(221,760
|
)
|
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Convertible senior notes - interest expense related to contractual coupon interest rate and amortization of discount and note issuance costs, net of tax
|
|
—
|
|
|
29,126
|
|
|
—
|
|
|||
Net income (loss) - diluted
|
|
$
|
424,362
|
|
|
$
|
779,395
|
|
|
$
|
(221,760
|
)
|
|
|
|
|
|
|
|
||||||
(Shares in thousands)
|
|
|
|
|
|
|
||||||
Weighted average shares - basic
|
|
97,917
|
|
|
94,685
|
|
|
90,610
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
10,233
|
|
|
14,231
|
|
|
—
|
|
|||
Restricted stock
|
|
433
|
|
|
715
|
|
|
—
|
|
|||
Convertible senior notes
|
|
—
|
|
|
4,761
|
|
|
—
|
|
|||
Warrants
|
|
2,707
|
|
|
990
|
|
|
—
|
|
|||
Dilutive potential shares
|
|
13,373
|
|
|
20,697
|
|
|
—
|
|
|||
Weighted average shares - diluted
|
|
111,290
|
|
|
115,382
|
|
|
90,610
|
|
|||
|
|
|
|
|
|
|
||||||
Net income (loss) per share - basic
|
|
$
|
4.33
|
|
|
$
|
7.92
|
|
|
$
|
(2.45
|
)
|
Net income (loss) per share - diluted
|
|
$
|
3.81
|
|
|
$
|
6.75
|
|
|
$
|
(2.45
|
)
|
|
|
December 31,
|
|||||||
(Shares in thousands)
|
|
2013
|
|
2012
|
|
2011
|
|||
Stock options
|
|
304
|
|
|
325
|
|
|
20,942
|
|
Restricted stock
|
|
—
|
|
|
—
|
|
|
846
|
|
Convertible senior notes
|
|
4,761
|
|
|
—
|
|
|
939
|
|
Warrants
|
|
—
|
|
|
—
|
|
|
939
|
|
|
|
First Quarter Ended
March 31, 2013
|
|
Second Quarter Ended
June 30, 2013
|
|
Third Quarter Ended
September 30, 2013
|
|
Fourth Quarter Ended
December 31, 2013
|
||||||||
|
|
(Unaudited)
|
||||||||||||||
Revenues
(1)
|
|
$
|
439,664
|
|
|
$
|
457,642
|
|
|
$
|
597,027
|
|
|
$
|
610,412
|
|
Net income
|
|
$
|
98,874
|
|
|
$
|
87,376
|
|
|
$
|
141,306
|
|
|
$
|
96,806
|
|
Net income per share - basic
|
|
$
|
1.02
|
|
|
$
|
0.89
|
|
|
$
|
1.44
|
|
|
$
|
0.98
|
|
Net income per share - diluted
|
|
$
|
0.90
|
|
|
$
|
0.79
|
|
|
$
|
1.25
|
|
|
$
|
0.86
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
First Quarter Ended
March 31, 2012
|
|
Second Quarter Ended
June 30, 2012
|
|
Third Quarter Ended
September 30, 2012
|
|
Fourth Quarter Ended
December 31, 2012
|
||||||||
|
|
(Unaudited)
|
||||||||||||||
Revenues
(2)
|
|
$
|
231,789
|
|
|
$
|
304,399
|
|
|
$
|
427,687
|
|
|
$
|
414,602
|
|
Net income
(3)
|
|
$
|
11,651
|
|
|
$
|
76,743
|
|
|
$
|
191,468
|
|
|
$
|
470,407
|
|
Net income per share - basic
|
|
$
|
0.12
|
|
|
$
|
0.81
|
|
|
$
|
2.02
|
|
|
$
|
4.92
|
|
Net income per share - diluted
|
|
$
|
0.11
|
|
|
$
|
0.70
|
|
|
$
|
1.72
|
|
|
$
|
4.08
|
|
|
Name of Subsidiary*
|
|
State or Other Jurisdiction of Incorporation or Organization
|
|
Regeneron Ireland
|
|
Ireland
|
|
Regeneron Ireland Holdings
|
|
Ireland
|
|
OSMR Holdings
|
|
Bermuda
|
|
Regeneron International Holdings LLC
|
|
Delaware
|
|
Regeneron UK Limited
|
|
United Kingdom
|
|
Regeneron Genetics Center LLC
|
|
Delaware
|
|
_____________
|
|
|
|
* 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 13, 2014
|
/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 13, 2014
|
/s/ Robert E. Landry
|
|
|
|
Robert E. Landry
|
|
|
|
Senior Vice President, Finance and Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Leonard S. Schleifer
|
Leonard S. Schleifer, M.D., Ph.D.
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
February 13, 2014
|
|
/s/ Robert E. Landry
|
Robert E. Landry
|
Senior Vice President, Finance and Chief Financial Officer
|
(Principal Financial Officer)
|
February 13, 2014
|