FORM 10-K
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(Mark One)
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(X)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended
December 31, 2014
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OR
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( )
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from __________ to __________
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Commission File Number: 0-19034
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New York
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13-3444607
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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777 Old Saw Mill River Road, Tarrytown, New York
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10591-6707
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common Stock - par value $.001 per share
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NASDAQ Global Select Market
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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
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Yes
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a
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No
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Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.
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Yes
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No
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a
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Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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Yes
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a
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No
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Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
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Yes
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a
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No
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§232.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this form 10-K.
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a
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
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Yes
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No
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a
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Class of Common Stock
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Number of Shares
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Class A Stock, $.001 par value
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1,971,868
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Common Stock, $.001 par value
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100,645,094
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Page Numbers
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"ARCALYST
®
", "EYLEA
®
", "ZALTRAP
®
", "
VelocImmune
®
", "
VelociGene
®
", "
VelociMouse
®
", "
VelociMab
®
", and "
VelociSuite
®
" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners.
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EYLEA (aflibercept) Injection, 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). In addition, in July 2014, August 2014, and November 2014, the U.S. Food and Drug Administration (FDA), European Commission, and Japanese Ministry of Health, Labour and Welfare (MHLW), respectively, approved EYLEA for the treatment of diabetic macular edema (DME). In September 2014, the Japanese MHLW approved EYLEA for myopic choroidal neovascularization (mCNV). In October 2014, the FDA approved EYLEA for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch retinal vein occlusion (BRVO). In November 2014, the FDA accepted for priority review the supplemental biologics application (sBLA) for EYLEA for the treatment of diabetic retinopathy in patients with DME, with a target action date of March 30, 2015. We are collaborating with Bayer HealthCare on the global development and commercialization of EYLEA outside the United States. Regulatory applications have been submitted for EYLEA in Europe and Japan for the treatment of macular edema following BRVO.
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ZALTRAP
®
(ziv-aflibercept) Injection for Intravenous Infusion, known in the scientific literature as VEGF Trap, which is available in the United States, EU, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. 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.
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ARCALYST
®
(rilonacept) Injection for Subcutaneous Use, which is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children 12 years and older.
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Trap-based Clinical Programs
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EYLEA
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In Phase 3 clinical development for the treatment of wet AMD (Asia) and DME (Asia) in collaboration with Bayer HealthCare. As described below, EYLEA is also being studied in combination with (i) an antibody to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta), and (ii) an antibody to angiopoietin-2 (Ang2).
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ZALTRAP
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In Phase 3 clinical development in metastatic colorectal cancer in the Asia-Pacific region (in collaboration with Sanofi).
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Antibody-based Clinical Programs in Collaboration with Sanofi
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PRALUENT (alirocumab/REGN727)
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Antibody to PCSK9. In Phase 3 clinical development for low-density lipoprotein (LDL) cholesterol reduction and for the prevention of cardiovascular events.
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Sarilumab (REGN88)
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Antibody to the interleukin-6 receptor (IL-6R). In clinical development in rheumatoid arthritis (Phase 3) and non-infectious uveitis (Phase 2).
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Dupilumab (REGN668)
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Antibody to the interleukin-4 receptor (IL-4R) alpha subunit. In clinical development in atopic dermatitis (Phase 3), asthma (Phase 2b), chronic sinusitis with nasal polyps (CSwNP) (Phase 2), and eosinophilic esophagitis (EoE) (Phase 2).
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REGN1033
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Antibody to myostatin (GDF8). In Phase 2 clinical development in skeletal muscle disorders.
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REGN2222
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Antibody against respiratory syncytial virus (RSV). Phase 1 clinical study initiated in the second quarter of 2014. In the fourth quarter of 2014, Sanofi provided notice to Regeneron that it had elected not to continue co-development of REGN2222 effective December 2015, and will be entitled to receive royalties on any future sales of the product candidate.
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Antibody-based Clinical Programs in Collaboration with Bayer HealthCare
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REGN2176-3
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Combination product comprised of an antibody to PDGFR-beta co-formulated with EYLEA for use in ophthalmology, via intravitreal administration. Phase 1 clinical study for the treatment of wet AMD initiated in the first quarter of 2014.
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Antibody-based Clinical Programs Developing Independently
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REGN1908-1909
*
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Antibody combination in Phase 1/Phase 2 clinical development against allergic disease.
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REGN1400
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Antibody to ErbB3. In Phase 1 clinical development in oncology.
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REGN1154
*
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Antibody against an undisclosed target. Phase 1 clinical study in Australia completed.
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REGN1500
*
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Antibody to Angptl-3 in Phase 1 clinical development. Studies are ongoing under a partial clinical hold by the FDA that excludes women of childbearing potential.
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REGN1193
*
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Antibody in Phase 1 clinical development against an undisclosed target.
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REGN1979
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Bispecific antibody against both CD20 and CD3 for use in oncology. Phase 1 clinical study initiated in the third quarter of 2014.
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REGN910-3
**
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Combination product comprised of an antibody to Ang2 co-formulated with EYLEA for use in ophthalmology, via intravitreal administration. Phase 1 clinical study initiated in the fourth quarter of 2014.
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REGN2810
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Antibody to PD-1. Phase 1 clinical study in oncology initiated in the first quarter of 2015.
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Fasinumab (REGN475)
*
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Antibody to Nerve Growth Factor (NGF). In development for the treatment of pain; currently on partial clinical hold by the FDA limiting duration of trials in osteoarthritis to 16 weeks.
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*
Sanofi did not opt-in to or elected not to continue to co-develop the product candidate and we have sole global rights. Under the terms of our agreement, Sanofi is entitled to receive a mid-single digit royalty on any future sales of the product candidate.
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**
We acquired from Sanofi full exclusive rights to antibodies targeting the Ang2 receptor and ligand in ophthalmology, which were previously included in our antibody collaboration with Sanofi. Under the terms of our agreement, Sanofi is entitled to receive a potential development milestone and royalties on any future sales of the product candidate.
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(continued)
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Study
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Patient group
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Primary efficacy endpoint
(percent change from baseline in LDL-C at 24 weeks)
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Most common AEs
a
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PRALUENT
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Comparator
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MONO
PRALUENT (n=52) vs. ezetimibe (n=51)
75 mg/150 mg dose
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Moderate CV risk
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48% reduction
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16% reduction (ezetimibe)
b
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Nasopharyngitis,
influenza, upper respiratory tract infection
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12% to 33% of dupilumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an IGA score of 0 or 1, compared to 2% with placebo (p=0.02 to p<0.0001).
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Dupilumab-treated patients experienced a 16.5% to 47% mean reduction in itching, as measured by the pruritus numerical-rating scale (NRS) score, compared to an increase of 5% in the placebo group (p=0.0005 to p<0.0001).
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In the high eosinophils patient group - mean improvements from baseline in FEV
1
(and mean percent change in FEV
1
) at 12 weeks, the primary (and a secondary) endpoint of the study were: 390 ml (26%) dupilumab 300 mg every other week (Q2W); 430 ml (26%) dupilumab 200 mg Q2W; 180 ml (10%) placebo. (p<0.01)
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In the overall population - mean improvements from baseline in FEV
1
at 12 weeks (and mean percent change in FEV
1
) were: 280 ml (18%) dupilumab 300 mg Q2W; 310 ml (18%) dupilumab 200 mg Q2W; 120 ml (6%) placebo. (p<0.001)
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In both the high eosinophils patient group and overall patient group - dupilumab showed a reduction in adjusted annualized rate of severe exacerbations compared to placebo (64% to 75% reduction, p<0.05 for high eosinophils group and p<0.01 for the overall population)
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Competitor
Product/Product
Candidate
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Commercial or
Development
Status
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Competitor
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Indication
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Territory
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Lucentis
®
(ranibizumab)
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Approved
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Novartis/Genentech
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Wet AMD, DME, macular edema following RVO, choroidal neovascularization secondary to pathologic myopia, diabetic retinopathy in patients with DME, and other eye indications
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Worldwide
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Avastin
®
(bevacizumab)
(off-label)
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Used to treat wet AMD, DME, and macular edema following RVO
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Genentech
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Wet AMD, DME, and macular edema following RVO
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Sold worldwide
Being evaluated in trials in the United Kingdom, Canada, Brazil, Germany, and other countries
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Conbercept
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Approved in China for wet AMD
In development for other eye indications
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Chengdu Kanghong Pharmaceutical Group
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Wet AMD
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China
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Fovista
TM
, an aptamer directed against PDGF-B
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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
)
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Ophthotech Corporation
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Wet AMD
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—
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RTH258 (ESBA1008), a single chain antibody fragment directed against VEGF-A
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In development (non-inferiority Phase 3 trial initiated in 2014 comparing RTH258 (ESBA1008) and EYLEA)
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Novartis
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Wet AMD
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—
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Abicipar pegol (anti-VEGF-A-DARPin
®
)
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In development (Phase 2)
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Allergan
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Wet AMD and related conditions
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—
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Bi-specific antibody
R06867461
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In development (Phase 1)
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Genentech
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Wet AMD
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—
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Lucentis
®
Sustained Delivery System
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In development (Phase 1)
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Genentech
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Wet AMD and related conditions
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—
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PF582, a biosimilar to Lucentis
®
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In development (Phase 1/2)
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Pfenex Inc.
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Wet AMD and related conditions
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—
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Competitor Product/Product Candidate
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Commercial or
Development
Status
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Competitor
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Indication
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Territory
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Avastin
®
(
bevacizumab)
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Approved and launched in 2004
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Genentech
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Certain cancers
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Worldwide
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Oral medications that target tumor cell growth and new vasculature formation that fuels growth of tumors
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Being sold and marketed
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Pfizer, Amgen (together with its partner Bayer HealthCare), GlaxoSmithKline, and Bayer HealthCare
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Certain cancers
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Worldwide
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Other VEGF antagonists
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In various phases of development
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Novartis, Amgen, Imclone LLC/Eli Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, and Aveo Pharmaceuticals, Inc.
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Certain cancers
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—
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Regeneron Antibody
Program
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Competitor
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Competitor
Product/Product
Candidate
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Commercial or
Development
Status
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Target
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PRALUENT (Phase 3)
Target: PCSK9
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Amgen
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Evolocumab (AMG-145)
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In development (Phase 3)
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Antibody against PCSK9
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Pfizer
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Bococizumab (RN316 / PF-04950615
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In development (Phase 3)
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Antibody against PCSK9
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Eli Lilly
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LY3015014
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In development (Phase 2)
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Antibody against PCSK9
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Alnylam Pharmaceuticals, Inc. (in partnership with The Medicines Company)
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ALN-PCS
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In development (Phase 1)
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RNAi against PCSK9
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(continued)
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Regeneron Antibody
Program
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Competitor
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Competitor
Product/Product
Candidate
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Commercial or
Development
Status
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Target
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Sarilumab (Phase 3)
Target: IL-6R
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Roche
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Actemra
®
(Tocilizumab)
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Approved
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Antibody against IL-6R for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis
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Johnson & Johnson (in partnership with GlaxoSmithKline)
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Sirukumab
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In development (Phase 3)
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Antibody against IL-6
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Alder Biopharmaceuticals, Inc.
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Clazakizumab
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In development (Phase 2)
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Antibody against IL-6
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Ablynx (in partnership with AbbVie)
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ALX-0061
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In development (Phase 2)
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Antibody against IL-6R
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R-Pharm
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Olokizumab
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In development (Phase 2)
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Antibody against IL-6
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Pfizer
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PF-04236921
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In development (Phase 1/Phase 2)
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Antibody against IL-6
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Roche
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SA 237
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In development (Phase 1/Phase 3)
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Antibody against IL-6R
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Dupilumab (Phase 2/Phase 3)
Target: IL-4R
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Roche
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Lebrikizumab
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In development (Phase 3)
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Antibody against IL-13
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Teva
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Reslizumab
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In development (Phase 3)
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Antibody against IL-5
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GlaxoSmithKline
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Mepolizumab
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In development (Phase 3)
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Antibody against IL-5
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AstraZeneca
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Benralizumab
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In development (Phase 3)
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Antibody against IL-5R
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AstraZeneca
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Tralokinumab
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In development (Phase 3)
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Antibody against IL-13
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Novartis
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QBX258
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In development (Phase 2)
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Fixed dose combination of antibodies against IL-4 and IL-13
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•
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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;
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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;
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our ability to meet the demand for commercial supplies of EYLEA;
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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 repackaged Avastin
®
to EYLEA;
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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;
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our ability to maintain sales of EYLEA in the face of competitive products, including those currently in clinical development; and
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the effect of existing and new health care laws and regulations currently being implemented in the United States, including reporting and disclosure requirements of such laws and regulations and the potential impact of such requirements on physician prescription practices.
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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;
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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;
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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
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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.
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unfamiliar foreign laws or regulatory requirements or unexpected changes to those laws or requirements;
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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
");
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changes in the political or economic condition of a specific country or region;
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fluctuations in the value of foreign currency versus the U.S. dollar;
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our ability to deploy overseas funds in an efficient manner;
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tariffs, trade protection measures, import or export licensing requirements, trade embargoes, and other trade barriers;
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difficulties in attracting and retaining qualified personnel; and
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cultural differences in the conduct of business.
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fluctuations in our operating results, in particular net product sales of EYLEA and, to a lesser degree, sales of ZALTRAP;
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•
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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;
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market acceptance of, and fluctuations in market share for, our marketed products, especially EYLEA;
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whether our net products sales and net profits underperform, meet, or exceed the expectations of investors or analysts;
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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;
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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;
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progress, delays, or results in clinical trials of our or our competitors' product candidates or new indications for marketed products;
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announcement of technological innovations or product candidates by us or competitors;
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claims by others that our products or technologies infringe their patents;
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challenges by others to our patents in the European Patent Office and in the U.S. Patent and Trademark Office;
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public concern as to the safety or effectiveness of any of our marketed products or product candidates or new indications for our marketed products;
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pricing or reimbursement actions, decisions, or recommendations by government authorities, insurers, or other organizations (such as health maintenance organizations and pharmacy benefit management companies) affecting the coverage, reimbursement, or use of any of our marketed products or competitors' products;
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our ability to raise additional capital as needed on favorable terms;
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developments in our relationships with collaborators or key customers;
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developments in the biotechnology industry or in government regulation of healthcare, including those relating to compounding;
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large sales of our Common Stock by our executive officers, directors, or significant shareholders;
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changes in tax rates, laws, or interpretation of tax laws;
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arrivals and departures of key personnel;
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general market conditions;
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other factors identified in these "Risk Factors"; and
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the perception by the investment community or our shareholders of any of the foregoing factors.
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our current executive officers and directors beneficially owned 10.7% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options held by such persons which are exercisable within 60 days of December 31, 2014, and 22.3% 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, 2014; and
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•
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our five largest shareholders plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately 48.7% 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
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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;
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a staggered board of directors, so that it would take three successive annual meetings to replace all of our directors;
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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;
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•
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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;
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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
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•
|
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
|
|
706,000
|
|
|
June 2024 - June 2029
|
|
$
|
2,375,000
|
|
|
Three 5-year terms
|
Tarrytown, New York
(2)
|
|
297,000
|
|
|
June 2029
|
|
—
|
|
Three 5-year terms
|
|
|
High
|
|
Low
|
||||
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
|
|
||
|
|
|
|
|
||||
2014
|
|
|
|
|
||||
First Quarter
|
|
$
|
352.49
|
|
|
$
|
262.97
|
|
Second Quarter
|
|
320.00
|
|
|
269.50
|
|
||
Third Quarter
|
|
369.31
|
|
|
285.06
|
|
||
Fourth Quarter
|
|
437.64
|
|
|
320.06
|
|
|
12/31/2009
|
|
12/31/2010
|
|
12/31/2011
|
|
12/31/2012
|
|
12/31/2013
|
|
12/31/2014
|
||||||||||||
Regeneron
|
$
|
100.00
|
|
|
$
|
135.77
|
|
|
$
|
229.24
|
|
|
$
|
707.49
|
|
|
$
|
1,138.30
|
|
|
$
|
1,696.65
|
|
S&P 500
|
100.00
|
|
|
112.78
|
|
|
112.78
|
|
|
127.90
|
|
|
165.76
|
|
|
184.64
|
|
||||||
NQ US Pharma TR Index
|
100.00
|
|
|
102.60
|
|
|
120.54
|
|
|
137.81
|
|
|
186.98
|
|
|
227.77
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||
(In thousands, except per share data)
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
|
$
|
1,750,762
|
|
|
$
|
1,425,839
|
|
|
$
|
858,093
|
|
|
$
|
44,686
|
|
|
$
|
25,254
|
|
Collaboration revenue
|
|
1,036,854
|
|
|
650,400
|
|
|
493,913
|
|
|
369,681
|
|
|
386,725
|
|
|||||
Technology licensing and other revenue
|
|
31,941
|
|
|
28,506
|
|
|
26,471
|
|
|
31,457
|
|
|
47,095
|
|
|||||
|
|
2,819,557
|
|
|
2,104,745
|
|
|
1,378,477
|
|
|
445,824
|
|
|
459,074
|
|
|||||
Expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
1,271,353
|
|
|
859,947
|
|
|
625,554
|
|
|
529,506
|
|
|
489,252
|
|
|||||
Selling, general, and administrative
|
|
504,755
|
|
|
329,415
|
|
|
210,755
|
|
|
117,261
|
|
|
65,201
|
|
|||||
Cost of goods sold
|
|
129,030
|
|
|
118,048
|
|
|
83,927
|
|
|
4,216
|
|
|
2,093
|
|
|||||
Cost of collaboration manufacturing
|
|
75,988
|
|
|
37,307
|
|
|
528
|
|
|
—
|
|
|
—
|
|
|||||
|
|
1,981,126
|
|
|
1,344,717
|
|
|
920,764
|
|
|
650,983
|
|
|
556,546
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) from operations
|
|
838,431
|
|
|
760,028
|
|
|
457,713
|
|
|
(205,159
|
)
|
|
(97,472
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Other income (expense)
|
|
(62,684
|
)
|
|
(46,668
|
)
|
|
(43,292
|
)
|
|
(17,733
|
)
|
|
(6,996
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) before income taxes
|
|
775,747
|
|
|
713,360
|
|
|
414,421
|
|
|
(222,892
|
)
|
|
(104,468
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income tax (expense) benefit
(1)
|
|
(427,673
|
)
|
|
(288,998
|
)
|
|
335,848
|
|
|
1,132
|
|
|
—
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss)
|
|
$
|
348,074
|
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
|
$
|
(221,760
|
)
|
|
$
|
(104,468
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss) per share - basic
|
|
$
|
3.46
|
|
|
$
|
4.33
|
|
|
$
|
7.92
|
|
|
$
|
(2.45
|
)
|
|
$
|
(1.26
|
)
|
Net income (loss) per share - diluted
|
|
$
|
3.07
|
|
|
$
|
3.81
|
|
|
$
|
6.75
|
|
|
$
|
(2.45
|
)
|
|
$
|
(1.26
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
As of December 31,
|
||||||||||||||||||
(In thousands)
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Unrestricted and restricted cash, cash equivalents, and marketable securities (current and non-current)
|
|
$
|
1,360,634
|
|
|
$
|
1,083,875
|
|
|
$
|
587,511
|
|
|
$
|
810,550
|
|
|
$
|
626,939
|
|
Total assets
|
|
3,871,827
|
|
|
2,951,013
|
|
|
2,080,490
|
|
|
1,323,583
|
|
|
1,089,432
|
|
|||||
Convertible senior notes (current and non-current)
|
|
146,773
|
|
|
320,315
|
|
|
296,518
|
|
|
275,019
|
|
|
—
|
|
|||||
Facility lease obligations (current and non-current)
|
|
312,291
|
|
|
185,197
|
|
|
160,810
|
|
|
160,514
|
|
|
160,030
|
|
|||||
Capital lease obligations (current and non-current)
|
|
—
|
|
|
126
|
|
|
1,309
|
|
|
2,506
|
|
|
2,829
|
|
|||||
Stockholders' equity
|
|
2,542,325
|
|
|
1,952,076
|
|
|
1,245,385
|
|
|
485,732
|
|
|
527,815
|
|
ITEM 7.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
EYLEA (aflibercept) Injection.
We commenced sales of EYLEA for the treatment of wet AMD in November 2011, for the treatment of macular edema following CRVO in September 2012, and for the treatment of DME in July 2014, following receipt of regulatory approval in the United States. In addition, in October 2014, the FDA approved EYLEA for the treatment of macular edema following RVO, which includes macular edema following BRVO. Bayer HealthCare commenced sales of EYLEA for the treatment of wet AMD in the fourth quarter of 2012 and for the treatment of macular edema secondary to CRVO in the fourth quarter of 2013 following receipt of regulatory approvals outside the United States. In addition, Bayer HealthCare commenced sales of EYLEA for the treatment of visual impairment due to DME in the third quarter of 2014 following receipt of regulatory approval in the EU. In September 2014, the Japanese MHLW approved EYLEA for mCNV. Bayer HealthCare has additional regulatory applications for EYLEA for the treatment of wet AMD, macular edema secondary to CRVO, and DME pending in other countries. In addition, Bayer HealthCare has submitted applications to the EMA and MHLW seeking marketing authorization in the EU and Japan, respectively, for EYLEA for the treatment of macular edema following BRVO.
|
•
|
ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion.
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. 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
$91.4 million
in
2014
, $
70.2 million
in
2013
, and
$31.7 million
in 2012. 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.
ARCALYST is available in the United States for the treatment of CAPS in adults and children 12 years and older. CAPS are a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or
|
Trap-based Clinical Programs
|
|
EYLEA
|
|
In Phase 3 clinical development for the treatment of wet AMD (Asia) and DME (Asia) in collaboration with Bayer HealthCare. As described below, EYLEA is also being studied in combination with (i) an antibody to PDGFR-beta, and (ii) an antibody to Ang2.
|
|
ZALTRAP
|
|
In Phase 3 clinical development in metastatic colorectal cancer in the Asia-Pacific region (in collaboration with Sanofi).
|
|
Antibody-based Clinical Programs in Collaboration with Sanofi
|
|
PRALUENT
|
|
Antibody to PCSK9. In Phase 3 clinical development for LDL cholesterol reduction and for the prevention of cardiovascular events.
|
|
Sarilumab (REGN88)
|
|
Antibody to IL-6R. In clinical development in rheumatoid arthritis (Phase 3) and non-infectious uveitis (Phase 2).
|
|
Dupilumab (REGN668)
|
|
Antibody to the IL-4R alpha subunit. In clinical development in atopic dermatitis (Phase 3), asthma (Phase 2b), CSwNP (Phase 2), and EoE (Phase 2).
|
|
REGN1033
|
|
Antibody to GDF8. In Phase 2 clinical development in skeletal muscle disorders.
|
|
REGN2222
|
|
Antibody against RSV. Phase 1 clinical study initiated in the second quarter of 2014. In the fourth quarter of 2014, Sanofi provided notice to Regeneron that it had elected not to continue co-development of REGN2222 effective December 2015, and will be entitled to receive royalties on any future sales of the product candidate.
|
|
Antibody-based Clinical Programs in Collaboration with Bayer HealthCare
|
|
REGN2176-3
|
|
Combination product comprised of an antibody to PDGFR-beta co-formulated with EYLEA for use in ophthalmology, via intravitreal administration. Phase 1 clinical study for the treatment of wet AMD initiated in the first quarter of 2014.
|
Antibody-based Clinical Programs Developing Independently
|
|
REGN1908-1909
*
|
|
Antibody combination in Phase 1/Phase 2 clinical development against allergic disease.
|
|
REGN1400
|
|
Antibody to ErbB3. In Phase 1 clinical development in oncology.
|
|
REGN1154
*
|
|
Antibody against an undisclosed target. Phase 1 clinical study in Australia completed.
|
|
REGN1500
*
|
|
Antibody to Angptl-3 in Phase 1 clinical development. Studies are ongoing under a partial clinical hold by the FDA that excludes women of childbearing potential.
|
|
REGN1193
*
|
|
Antibody in Phase 1 clinical development against an undisclosed target.
|
|
REGN1979
|
|
Bispecific antibody against both CD20 and CD3 for use in oncology. Phase 1 clinical study initiated in the third quarter of 2014.
|
|
REGN910-3
**
|
|
Combination product comprised of an antibody to Ang2 co-formulated with EYLEA for use in ophthalmology, via intravitreal administration. Phase 1 clinical study initiated in the fourth quarter of 2014.
|
|
REGN2810
|
|
Antibody to PD-1. Phase 1 clinical study initiated in the first quarter of 2015 in oncology.
|
|
Fasinumab (REGN475)
*
|
|
Antibody to NGF. In development for the treatment of pain; currently on partial clinical hold by the FDA limiting duration of trials in osteoarthritis to 16 weeks.
|
*
Sanofi did not opt-in to or elected not to continue to co-develop the product candidate and we have sole global rights. Under the terms of our agreement, Sanofi is entitled to receive a mid-single digit royalty on any future sales of the product candidate.
|
||||
**
We acquired from Sanofi full exclusive rights to antibodies targeting the Ang2 receptor and ligand in ophthalmology, which were previously included in our antibody collaboration with Sanofi. Under the terms of our agreement, Sanofi is entitled to receive a potential development milestone and royalties on any future sales of the product candidate.
|
|
|
2014 and 2015 Events to Date
|
|
2015 Plans
|
PRALUENT (PCSK9 Antibody)
|
|
Initiated Phase 3 ODYSSEY CHOICE II trial
|
|
Continue enrollment of Phase 3 ODYSSEY OUTCOMES trial
|
|
|
Initiated Phase 3 program in Japan
|
|
Report results from additional Phase 3 ODYSSEY trials
|
|
|
Reported positive top-line results from nine Phase 3 ODYSSEY studies
|
|
File for additional regulatory approvals outside the United States
|
|
|
Detailed positive results from four Phase 3 ODYSSEY trials presented at the ESC Congress 2014
|
|
FDA decision on U.S. regulatory application
|
|
|
BLA accepted for priority review in the United States
|
|
|
|
|
Regulatory application accepted for review by the EMA
|
|
|
|
|
Reported positive topline results from ODYSSEY CHOICE I and CHOICE II trials
|
|
|
Sarilumab (IL-6R Antibody)
|
|
Obtained positive results from Phase 1b RA trial in Japan
|
|
Continue enrollment in Phase 3 SARIL-RA program
|
|
|
Positive results from Phase 3 SARIL-RA-MOBILITY trial presented at EULAR and ACR conferences
|
|
Complete patient enrollment in SARIL-NIU-SATURN Phase 2 study in
non-infectious uveitis
|
|
|
SARIL-RA-COMPARE Phase 3 study discontinued
|
|
Report results from additional Phase 3 trials
|
|
|
Initiated additional clinical studies, including Phase 3 MONARCH study (head-to-head monotherapy study against adalimumab)
|
|
Submit for regulatory approval in the United States
|
|
|
Completed patient enrollment in SARIL-RA-TARGET, SARIL-RA-ASCERTAIN, SARIL-RA-ONE and SARIL-RA-EASY trials
|
|
|
Dupilumab (IL-4R Antibody)
|
|
Reported positive Phase 2a data in atopic dermatitis
|
|
Continue enrollment in LIBERTY AD Phase 3 studies in atopic dermatitis
|
|
|
Reported positive Phase 2b data in atopic dermatitis
|
|
Initiate Phase 3 studies in asthma and CSwNP
|
|
|
Reported positive Phase 2 data in CSwNP
|
|
|
|
|
Initiated LIBERTY AD Phase 3 studies in atopic dermatitis
|
|
|
|
|
Reported positive Phase 2b data in asthma
|
|
|
|
|
Received Breakthrough Therapy designation from the FDA for the treatment of adults with moderate-to-severe atopic dermatitis
|
|
|
|
|
Initiated Phase 2 study in EoE
|
|
|
REGN1033 (GDF8 Antibody)
|
|
Completed patient enrollment in Phase 1 and Phase 2a studies
|
|
Report Phase 2a proof-of-concept data
|
REGN1908-1909 (target not disclosed)
|
|
Completed patient enrollment of First in Human study
|
|
Continue patient enrollment in Phase 2 study
|
|
|
Initiated Phase 2 study
|
|
|
REGN1400 (ErbB3 Antibody)
|
|
Completed patient enrollment in Phase 1 study
|
|
Determine future development plan
|
REGN1154 (target not disclosed)
|
|
|
|
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
|
|
||||
Provision related to current period sales
|
33.1
|
|
|
77.2
|
|
|
1.6
|
|
|
111.9
|
|
||||
Credits/payments
|
(34.4
|
)
|
|
(75.7
|
)
|
|
(1.6
|
)
|
|
(111.7
|
)
|
||||
Balance as of December 31, 2014
|
$
|
3.1
|
|
|
$
|
21.2
|
|
|
$
|
0.5
|
|
|
$
|
24.8
|
|
(In millions)
|
2014
|
|
2013
|
||||
Revenues
|
$
|
2,819.6
|
|
|
$
|
2,104.7
|
|
Operating expenses
|
(1,981.1
|
)
|
|
(1,344.7
|
)
|
||
Other income (expense)
|
(62.7
|
)
|
|
(46.6
|
)
|
||
Income before income taxes
|
775.8
|
|
|
713.4
|
|
||
Income tax expense
|
(427.7
|
)
|
|
(289.0
|
)
|
||
Net income
|
$
|
348.1
|
|
|
$
|
424.4
|
|
(In millions)
|
2014
|
|
2013
|
||||
Net product sales
|
$
|
1,750.8
|
|
|
$
|
1,425.8
|
|
Collaboration revenue:
|
|
|
|
||||
Sanofi
|
541.3
|
|
|
430.1
|
|
||
Bayer HealthCare
|
495.6
|
|
|
220.3
|
|
||
Total collaboration revenue
|
1,036.9
|
|
|
650.4
|
|
||
Technology licensing and other revenue
|
31.9
|
|
|
28.5
|
|
||
Total revenue
|
$
|
2,819.6
|
|
|
$
|
2,104.7
|
|
Sanofi Collaboration Revenue
|
|
Year Ended
December 31, |
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
ZALTRAP:
|
|
|
|
|
||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
$
|
(4.7
|
)
|
|
$
|
(30.8
|
)
|
Reimbursement of Regeneron research and development expenses
|
|
4.8
|
|
|
5.6
|
|
||
Other
|
|
5.1
|
|
|
9.7
|
|
||
Total ZALTRAP
|
|
5.2
|
|
|
(15.5
|
)
|
||
Antibody:
|
|
|
|
|
||||
Reimbursement of Regeneron research and development expenses
|
|
547.8
|
|
|
453.5
|
|
||
Reimbursement of Regeneron commercialization-related expenses
|
|
19.5
|
|
|
1.9
|
|
||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(41.4
|
)
|
|
—
|
|
||
Up-front payments to Sanofi for acquisition of rights related to two antibodies
|
|
—
|
|
|
(20.0
|
)
|
||
Other
|
|
10.2
|
|
|
10.2
|
|
||
Total Antibody
|
|
536.1
|
|
|
445.6
|
|
||
Total Sanofi collaboration revenue
|
|
$
|
541.3
|
|
|
$
|
430.1
|
|
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
Year Ended December 31,
|
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
Net product sales recorded by Sanofi
|
|
$
|
91.4
|
|
|
$
|
70.2
|
|
Regeneron's share of collaboration losses
|
|
(4.7
|
)
|
|
(30.8
|
)
|
Bayer HealthCare Collaboration Revenue
|
|
Year Ended
December 31, |
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
EYLEA:
|
|
|
|
|
||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
301.3
|
|
|
$
|
101.5
|
|
Sales and substantive development milestones
|
|
105.0
|
|
|
70.0
|
|
||
Cost-sharing of Regeneron EYLEA development expenses
|
|
23.4
|
|
|
20.9
|
|
||
Other
|
|
52.4
|
|
|
27.9
|
|
||
Total EYLEA
|
|
482.1
|
|
|
220.3
|
|
||
PDGFR-beta antibody:
|
|
|
|
|
||||
Cost-sharing of REGN2176-3 development expenses
|
|
2.9
|
|
|
—
|
|
||
Other
|
|
10.6
|
|
|
—
|
|
||
Total PDGFR-beta
|
|
13.5
|
|
|
—
|
|
||
Total Bayer HealthCare collaboration revenue
|
|
$
|
495.6
|
|
|
$
|
220.3
|
|
Regeneron's Net Profit from EYLEA Sales Outside the United States
|
|
Year Ended
December 31,
|
||||||
(In millions)
|
|
2014
|
|
2013
|
||||
Net product sales outside the United States
|
|
$
|
1,038.5
|
|
|
$
|
472.1
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
358.3
|
|
|
159.1
|
|
||
Reimbursement of EYLEA development expenses incurred by Bayer HealthCare in accordance with Regeneron's payment obligation
|
|
(57.0
|
)
|
|
(57.6
|
)
|
||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
301.3
|
|
|
$
|
101.5
|
|
Research and Development Expenses
*
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Payroll and benefits
(1)
|
|
$
|
401.6
|
|
|
$
|
290.7
|
|
|
$
|
110.9
|
|
Clinical trial expenses
|
|
203.0
|
|
|
139.5
|
|
|
63.5
|
|
|||
Clinical manufacturing costs
(2)
|
|
284.8
|
|
|
237.3
|
|
|
47.5
|
|
|||
Research and other development costs
|
|
137.2
|
|
|
73.1
|
|
|
64.1
|
|
|||
Occupancy and other operating costs
|
|
116.5
|
|
|
86.4
|
|
|
30.1
|
|
|||
Cost-sharing of Bayer HealthCare and Sanofi development expenses
(3)
|
|
128.3
|
|
|
32.9
|
|
|
95.4
|
|
|||
Total research and development expenses
|
|
$
|
1,271.4
|
|
|
$
|
859.9
|
|
|
$
|
411.5
|
|
Project Costs
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
(In millions)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
EYLEA
|
|
$
|
110.4
|
|
|
$
|
133.3
|
|
|
$
|
(22.9
|
)
|
PRALUENT
|
|
316.4
|
|
|
152.2
|
|
|
164.2
|
|
|||
Sarilumab
|
|
86.1
|
|
|
51.9
|
|
|
34.2
|
|
|||
Dupilumab
|
|
169.0
|
|
|
89.0
|
|
|
80.0
|
|
|||
Other antibody candidates in clinical development
|
|
196.5
|
|
|
120.3
|
|
|
76.2
|
|
|||
Other research programs and unallocated costs
|
|
393.0
|
|
|
313.2
|
|
|
79.8
|
|
|||
Total research and development expenses
|
|
$
|
1,271.4
|
|
|
$
|
859.9
|
|
|
$
|
411.5
|
|
(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
|
|
—
|
|
|
50.0
|
|
||
Reimbursement of Regeneron research and development expenses
|
|
5.6
|
|
|
10.7
|
|
||
Other
|
|
9.7
|
|
|
13.2
|
|
||
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 milestones
|
|
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)
|
|
$
|
290.7
|
|
|
$
|
210.3
|
|
|
$
|
80.4
|
|
Clinical trial expenses
|
|
139.5
|
|
|
92.3
|
|
|
47.2
|
|
|||
Clinical manufacturing costs
(2)
|
|
237.3
|
|
|
171.7
|
|
|
65.6
|
|
|||
Research and other development costs
|
|
73.1
|
|
|
58.0
|
|
|
15.1
|
|
|||
Occupancy and other operating costs
|
|
86.4
|
|
|
71.4
|
|
|
15.0
|
|
|||
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
|
|
PRALUENT
|
|
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
|
|
|
|
|
|
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)
|
|
$
|
175.7
|
|
|
$
|
13.2
|
|
|
$
|
162.5
|
|
|
—
|
|
|
—
|
|
||
Operating leases
(2)
|
|
108.6
|
|
|
10.8
|
|
|
19.8
|
|
|
$
|
19.7
|
|
|
$
|
58.3
|
|
|||
Purchase and other obligations
(3)
|
|
771.1
|
|
|
659.8
|
|
|
103.6
|
|
|
7.7
|
|
|
—
|
|
|||||
Facility lease obligations
(4)
|
|
286.6
|
|
|
18.1
|
|
|
37.4
|
|
|
39.0
|
|
|
192.1
|
|
|||||
Total contractual obligations
|
|
$
|
1,342.0
|
|
|
$
|
701.9
|
|
|
$
|
323.3
|
|
|
$
|
66.4
|
|
|
$
|
250.4
|
|
(1)
|
Consists of
$169.4 million
remaining 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 are 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. See Note 12 to our Consolidated Financial Statements.
|
(2)
|
Excludes future contingent costs for utilities, real estate taxes, and operating expenses. In 2014, these costs were
$13.6 million
. See Note 13(a) to our Consolidated Financial Statements.
|
(3)
|
Purchase and other obligations primarily relate to (i) a $59.8 million payment expected to be made in February 2015 to a warrant holder (see Note 12 to our Consolidated Financial Statements), (ii) research and development commitments, including those related to clinical trials, (iii) capital expenditures for equipment acquisitions, and (iv) 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 the second half of
2015
, and will be based on several factors, including 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, relating to 1.875% Convertible Senior Notes due October 1, 2016, between Regeneron Pharmaceuticals, Inc. (the "Registrant") 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)
|
–
|
Regeneron Pharmaceuticals, Inc. 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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan.
|
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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan.
|
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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan.
|
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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan.
|
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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan.
|
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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan (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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan (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 under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan (revised)
|
10.1.10 +
|
|
(gg)
|
–
|
Amendment No. 1 to the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan.
|
10.2 +
|
|
(hh)
|
–
|
Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan.
|
10.2.1 +
|
|
(ii)
|
–
|
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan.
|
10.2.2 +
|
|
(ii)
|
–
|
Form of stock option agreement and related notice of grant for use in connection with the grant of incentive stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan.
|
10.2.3 +
|
|
(ii)
|
–
|
Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan.
|
10.2.4 +
|
|
(ii)
|
–
|
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan.
|
10.3 +
|
|
(p)
|
–
|
Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S. Schleifer, M.D., Ph.D.
|
10.4* +
|
|
(d)
|
–
|
Employment Agreement, dated as of December 31, 1998, between the Registrant and P. Roy Vagelos, M.D.
|
10.5 +
|
|
(ee)
|
–
|
Offer Letter for Robert E. Landry effective September 9, 2013.
|
10.6 +
|
|
(p)
|
–
|
Regeneron Pharmaceuticals, Inc. Change in Control Severance Plan, amended and restated effective as of November 14, 2008.
|
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*
|
|
|
–
|
Restated Amendment Agreement, dated December 30, 2014 and entered into effective as of May 7, 2012, by and between Bayer HealthCare LLC and the Registrant.
|
10.11
|
|
(kk)
|
–
|
License and Collaboration Agreement, dated as of January 10, 2014, by and between Bayer HealthCare LLC and the Registrant.
|
10.12
|
|
(j)
|
–
|
Lease, dated as of December 21, 2006, by and between BMR-Landmark at Eastview LLC and the Registrant.
|
10.12.1*
|
|
(l)
|
–
|
First Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, effective as of October 24, 2007.
|
10.12.2
|
|
(o)
|
–
|
Second Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, effective as of September 30, 2008.
|
10.12.3
|
|
(q)
|
–
|
Third Amendment to lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of April 29, 2009.
|
10.12.4
|
|
(s)
|
–
|
Fourth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, effective as of December 3, 2009.
|
10.12.5
|
|
(t)
|
–
|
Fifth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of February 11, 2010.
|
10.12.6
|
|
(w)
|
–
|
Sixth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 4, 2010.
|
10.12.7
|
|
(y)
|
–
|
Seventh Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of December 22, 2010.
|
10.12.8
|
|
(bb)
|
–
|
Eighth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of August 1, 2011.
|
10.12.9
|
|
(bb)
|
–
|
Ninth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of September 30, 2011.
|
10.12.10
|
|
(ff)
|
–
|
Eleventh Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, dated April 3, 2013.
|
10.12.11
|
|
(ff)
|
–
|
Twelfth Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, dated May 31, 2013.
|
10.12.12
|
|
(ff)
|
–
|
Thirteenth Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, dated May 31, 2013.
|
10.13
|
|
(ff)
|
–
|
Mt. Pleasant Lease by and between BMR-Landmark at Eastview LLC and the Registrant, dated April 3, 2013.
|
10.14*
|
|
(k)
|
–
|
Non Exclusive License and Material Transfer Agreement, dated as of March 30, 2007, by and between Astellas Pharma Inc. and the Registrant.
|
10.14.1*
|
|
(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.
|
10.15*
|
|
(v)
|
–
|
Amended and Restated Discovery and Preclinical Development Agreement, dated as of November 10, 2009, by and between Aventis Pharmaceuticals Inc. and the Registrant.
|
10.16*
|
|
(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.
|
10.16.1*
|
|
(ff)
|
–
|
First Amendment to Amended and Restated License and Collaboration Agreement by and between the Registrant and Aventis Pharmaceuticals Inc., dated May 1, 2013.
|
10.17
|
|
(jj)
|
–
|
Amended and Restated Investor Agreement, dated as of January 11, 2014, by and among Sanofi, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant.
|
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 the Registrant and Goldman, Sachs & Co.
|
10.20
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Goldman, Sachs & Co. and the Registrant.
|
10.21
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Goldman, Sachs & Co. and the Registrant.
|
10.21.1
|
|
(ll)
|
–
|
Amendment, dated as of May 15, 2014, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant.
|
10.21.2
|
|
|
–
|
Second Amendment, dated as of November 25, 2014, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant.
|
10.22
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Citibank, N.A. and the Registrant.
|
10.23
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Citibank, N.A. and the Registrant.
|
10.23.1
|
|
(ll)
|
–
|
Amendment, dated as of May 13, 2014, to the Master Terms and Conditions for Warrants, between Citibank, N.A. and the Registrant.
|
10.24
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Credit Suisse International and the Registrant.
|
10.25
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Credit Suisse International and the Registrant.
|
10.25.1
|
|
(ll)
|
–
|
Amendment, dated as of May 14, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant.
|
10.25.2
|
|
|
–
|
Second Amendment, dated as of November 18, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant.
|
10.25.3
|
|
|
–
|
Third Amendment, dated as of November 24, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant.
|
10.26
|
|
(aa)
|
–
|
Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Morgan Stanley & Co. International plc and the Registrant.
|
10.27
|
|
(aa)
|
–
|
Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Morgan Stanley & Co. International plc and the Registrant.
|
10.27.1
|
|
(ll)
|
–
|
Amendment, dated as of May 16, 2014, to the Master Terms and Conditions for Warrants, between Morgan Stanley & Co. International plc and the Registrant.
|
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 the Registrant, effective May 17, 2013.
|
10.28.2*
|
|
(ff)
|
–
|
Non-Exclusive License and Settlement Agreement by and between Genentech, Inc., the Registrant, 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, the Registrant, Regeneron UK Ltd and Genentech Inc.
|
10.29*
|
|
(ff)
|
–
|
Letter Agreement by and between the Registrant and Aventis Pharmaceuticals Inc., dated May 2, 2013.
|
21.1
|
|
|
–
|
Subsidiaries of the Registrant.
|
23.1
|
|
|
–
|
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
|
24.1
|
|
|
–
|
Power of Attorney (included on the signature page of this Annual Report on Form 10-K).
|
31.1
|
|
|
–
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
31.2
|
|
|
–
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
32
|
|
|
–
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
|
101
|
|
|
–
|
Interactive Data File
|
101.INS
|
|
|
–
|
XBRL Instance Document
|
101.SCH
|
|
|
–
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
|
|
–
|
XBRL Taxonomy Extension Calculation Linkbase
|
101.DEF
|
|
|
–
|
XBRL Taxonomy Extension Definition Document
|
101.LAB
|
|
|
–
|
XBRL Taxonomy Extension Label Linkbase
|
101.PRE
|
|
|
–
|
XBRL Taxonomy Extension Presentation Linkbase
|
_______
|
|
|
|
|
(a)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed November 13, 2007.
|
(b)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed December 16, 2005.
|
(c)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed December 13, 2004.
|
(d)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2004, filed March 11, 2005.
|
(f)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2003, filed November 12, 2003.
|
(g)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed January 11, 2005.
|
(h)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2005, filed February 28, 2006.
|
(i)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2006, filed November 6, 2006.
|
(j)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed December 22, 2006.
|
(k)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2007, filed May 4, 2007.
|
(l)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2007, filed November 7, 2007.
|
(m)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2007, filed February 27, 2008.
|
(n)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2008, filed August 1, 2008.
|
(o)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2008, filed November 5, 2008.
|
(p)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, 2009.
|
(q)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2009, filed April 30, 2009.
|
(r)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2009, filed August 4, 2009.
|
(s)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed December 8, 2009.
|
(t)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed February 16, 2010.
|
(u)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2009, filed February 18, 2010.
|
(v)
|
|
Incorporated by reference from the Form 10-K/A for the Registrant, for the year ended December 31, 2009, filed June 2, 2010.
|
(w)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2010, filed July 28, 2010.
|
(x)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2010, filed October 28, 2010.
|
(y)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2010, filed February 17, 2011.
|
(z)
|
|
Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 13, 2011.
|
(aa)
|
|
Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.
|
(bb)
|
|
Incorporated by reference from the Form 10-Q for the Registrant for the quarter ended September 30, 2011, filed October 27, 2011.
|
(cc)
|
|
Incorporated by reference from the Form 10-Q for the Registrant for the quarter ended June 30, 2012, filed July 25, 2012.
|
(dd)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2011, filed February 21, 2012.
|
(ee)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed September 12, 2013.
|
(ff)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.
|
(gg)
|
|
Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2013, filed February 13, 2014.
|
(hh)
|
|
Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 16, 2014.
|
(ii)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.
|
(jj)
|
|
Incorporated by reference from the Form 8-K for the Registrant, filed January 13, 2014.
|
(kk)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2014, filed May 8, 2014.
|
(ll)
|
|
Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.
|
_______
|
|
|
|
||
|
|
|
*
|
|
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 12, 2015
|
|
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 12, 2015
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
|
|
/s/ ROBERT E. LANDRY
|
|
Senior Vice President, Finance and Chief Financial Officer (Principal Financial Officer)
|
|
February 12, 2015
|
Robert E. Landry
|
|
|
|
|
/s/ DOUGLAS S. McCORKLE
|
|
Vice President, Controller, and Assistant Treasurer (Principal Accounting Officer)
|
|
February 12, 2015
|
Douglas S. McCorkle
|
|
|
|
|
/s/ GEORGE D. YANCOPOULOS
|
|
Chief Scientific Officer, President, Regeneron Laboratories, and Director
|
|
February 12, 2015
|
George D. Yancopoulos, M.D., Ph.D.
|
|
|
|
|
/s/ P. ROY VAGELOS
|
|
Chairman of the Board
|
|
February 12, 2015
|
P. Roy Vagelos, M.D.
|
|
|
|
|
/s/ CHARLES A. BAKER
|
|
Director
|
|
February 12, 2015
|
Charles A. Baker
|
|
|
|
|
/s/ MICHAEL S. BROWN
|
|
Director
|
|
February 12, 2015
|
Michael S. Brown, M.D.
|
|
|
|
|
/s/ ALFRED G. GILMAN
|
|
Director
|
|
February 12, 2015
|
Alfred G. Gilman, M.D., Ph.D.
|
|
|
|
|
/s/ JOSEPH L. GOLDSTEIN
|
|
Director
|
|
February 12, 2015
|
Joseph L. Goldstein, M.D.
|
|
|
|
|
/s/ ROBERT A. INGRAM
|
|
Director
|
|
February 12, 2015
|
Robert A. Ingram
|
|
|
|
|
/s/ CHRISTINE A. POON
|
|
Director
|
|
February 12, 2015
|
Christine A. Poon
|
|
|
|
|
/s/ ARTHUR F. RYAN
|
|
Director
|
|
February 12, 2015
|
Arthur F. Ryan
|
|
|
|
|
/s/ GEORGE L. SING
|
|
Director
|
|
February 12, 2015
|
George L. Sing
|
|
|
|
|
/s/ MARC TESSIER-LAVIGNE
|
|
Director
|
|
February 12, 2015
|
Marc Tessier-Lavigne, Ph.D.
|
|
|
|
|
|
|
Page Numbers
|
|
||
|
||
|
||
|
||
|
||
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
ASSETS
|
|||||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
648,719
|
|
|
$
|
535,608
|
|
Marketable securities
|
251,761
|
|
|
158,376
|
|
||
Accounts receivable - trade, net
|
739,379
|
|
|
787,071
|
|
||
Accounts receivable from Sanofi
|
121,058
|
|
|
104,707
|
|
||
Accounts receivable from Bayer HealthCare
|
156,962
|
|
|
63,189
|
|
||
Inventories
|
128,861
|
|
|
70,354
|
|
||
Deferred tax assets
|
49,235
|
|
|
44,677
|
|
||
Prepaid expenses and other current assets
|
71,486
|
|
|
32,952
|
|
||
Total current assets
|
2,167,461
|
|
|
1,796,934
|
|
||
|
|
|
|
||||
Marketable securities
|
460,154
|
|
|
389,891
|
|
||
Property, plant, and equipment, at cost, net of accumulated depreciation and amortization
|
974,309
|
|
|
526,983
|
|
||
Deferred tax assets
|
266,869
|
|
|
231,878
|
|
||
Other assets
|
3,034
|
|
|
5,327
|
|
||
Total assets
|
$
|
3,871,827
|
|
|
$
|
2,951,013
|
|
|
|
|
|
||||
LIABILITIES and STOCKHOLDERS' EQUITY
|
|||||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
484,228
|
|
|
$
|
250,896
|
|
Deferred revenue from Sanofi, current portion
|
15,927
|
|
|
12,815
|
|
||
Deferred revenue - other, current portion
|
58,098
|
|
|
34,185
|
|
||
Other current liabilities
|
96,407
|
|
|
939
|
|
||
Total current liabilities
|
654,660
|
|
|
298,835
|
|
||
|
|
|
|
||||
Deferred revenue from Sanofi
|
72,367
|
|
|
76,522
|
|
||
Deferred revenue - other
|
103,909
|
|
|
107,677
|
|
||
Facility lease obligations
|
310,938
|
|
|
184,258
|
|
||
Convertible senior notes
|
146,773
|
|
|
320,315
|
|
||
Other long-term liabilities
|
40,855
|
|
|
11,330
|
|
||
Total liabilities
|
1,329,502
|
|
|
998,937
|
|
||
|
|
|
|
||||
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 - 1,973,368 in 2014 and 2,020,481 in 2013
|
2
|
|
|
2
|
|
||
Common Stock, $.001 par value; 160,000,000 shares authorized; shares issued - 102,475,154 in 2014 and 97,666,814 in 2013
|
102
|
|
|
97
|
|
||
Additional paid-in capital
|
2,404,118
|
|
|
2,045,857
|
|
||
Retained earnings (accumulated deficit)
|
255,382
|
|
|
(92,692
|
)
|
||
Accumulated other comprehensive income (loss)
|
52,251
|
|
|
(1,188
|
)
|
||
Treasury stock, at cost; 2,017,732 shares in 2014 and none in 2013
|
(169,530
|
)
|
|
—
|
|
||
Total stockholders' equity
|
2,542,325
|
|
|
1,952,076
|
|
||
Total liabilities and stockholders' equity
|
$
|
3,871,827
|
|
|
$
|
2,951,013
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Statements of Operations
|
|
|
|
|
|
|
||||||
Revenues:
|
|
|
|
|
|
|
||||||
Net product sales
|
|
$
|
1,750,762
|
|
|
$
|
1,425,839
|
|
|
$
|
858,093
|
|
Sanofi collaboration revenue
|
|
541,299
|
|
|
430,111
|
|
|
423,814
|
|
|||
Bayer HealthCare collaboration revenue
|
|
495,555
|
|
|
220,289
|
|
|
70,099
|
|
|||
Technology licensing and other revenue
|
|
31,941
|
|
|
28,506
|
|
|
26,471
|
|
|||
|
|
2,819,557
|
|
|
2,104,745
|
|
|
1,378,477
|
|
|||
|
|
|
|
|
|
|
||||||
Expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
1,271,353
|
|
|
859,947
|
|
|
625,554
|
|
|||
Selling, general, and administrative
|
|
504,755
|
|
|
329,415
|
|
|
210,755
|
|
|||
Cost of goods sold
|
|
129,030
|
|
|
118,048
|
|
|
83,927
|
|
|||
Cost of collaboration manufacturing
|
|
75,988
|
|
|
37,307
|
|
|
528
|
|
|||
|
|
1,981,126
|
|
|
1,344,717
|
|
|
920,764
|
|
|||
|
|
|
|
|
|
|
||||||
Income from operations
|
|
838,431
|
|
|
760,028
|
|
|
457,713
|
|
|||
|
|
|
|
|
|
|
||||||
Other income (expense):
|
|
|
|
|
|
|
||||||
Investment and other income (expense)
|
|
8,157
|
|
|
(231
|
)
|
|
2,012
|
|
|||
Interest expense
|
|
(37,372
|
)
|
|
(46,437
|
)
|
|
(45,304
|
)
|
|||
Loss on extinguishment of debt
|
|
(33,469
|
)
|
|
—
|
|
|
—
|
|
|||
|
|
(62,684
|
)
|
|
(46,668
|
)
|
|
(43,292
|
)
|
|||
|
|
|
|
|
|
|
||||||
Income before income taxes
|
|
775,747
|
|
|
713,360
|
|
|
414,421
|
|
|||
|
|
|
|
|
|
|
||||||
Income tax (expense) benefit
|
|
(427,673
|
)
|
|
(288,998
|
)
|
|
335,848
|
|
|||
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
348,074
|
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
3.46
|
|
|
$
|
4.33
|
|
|
$
|
7.92
|
|
Net income per share - diluted
|
|
$
|
3.07
|
|
|
$
|
3.81
|
|
|
$
|
6.75
|
|
|
|
|
|
|
|
|
||||||
Weighted average shares outstanding - basic
|
|
100,612
|
|
|
97,917
|
|
|
94,685
|
|
|||
Weighted average shares outstanding - diluted
|
|
113,413
|
|
|
111,290
|
|
|
115,382
|
|
|||
|
|
|
|
|
|
|
||||||
Statements of Comprehensive Income
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
348,074
|
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
||||||
Unrealized gain (loss) on marketable securities, net of tax
|
|
53,439
|
|
|
(22
|
)
|
|
696
|
|
|||
Comprehensive income
|
|
$
|
401,513
|
|
|
$
|
424,340
|
|
|
$
|
750,965
|
|
|
|
|
|
|
|
|
||||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Class A Stock
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Retained Earnings (Accumulated Deficit)
|
|
Treasury Stock
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholders' Equity
|
|||||||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||
Balance, December 31, 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
|
|
|||||||
Excess tax benefit from stock-based compensation
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,308
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,308
|
|
|||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
750,269
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
750,269
|
|
|||||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
696
|
|
|
696
|
|
|||||||
Balance, December 31, 2012
|
|
2,069
|
|
|
2
|
|
|
95,223
|
|
|
95
|
|
|
1,763,508
|
|
|
(517,054
|
)
|
|
—
|
|
|
—
|
|
|
(1,166
|
)
|
|
1,245,385
|
|
|||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
3,052
|
|
|
3
|
|
|
54,759
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
54,762
|
|
|||||||
Common Stock tendered upon exercise of stock options in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(644
|
)
|
|
(1
|
)
|
|
(179,422
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(179,423
|
)
|
|||||||
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
|
|
—
|
|
|
—
|
|
|
38
|
|
|
—
|
|
|
5,718
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,718
|
|
|||||||
Issuance of restricted Common Stock under Long-Term Incentive Plan
|
|
—
|
|
|
—
|
|
|
6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Restricted Common Stock tendered upon vesting in connection with employee tax obligations
|
|
—
|
|
|
—
|
|
|
(57
|
)
|
|
—
|
|
|
(15,664
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,664
|
)
|
|||||||
Conversion of Class A Stock to Common Stock
|
|
(49
|
)
|
|
—
|
|
|
49
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||||||
Net income
|
|
$
|
348,074
|
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
52,686
|
|
|
41,204
|
|
|
36,940
|
|
|||
Non-cash compensation expense
|
|
307,238
|
|
|
198,399
|
|
|
94,157
|
|
|||
Non-cash interest expense
|
|
18,052
|
|
|
23,061
|
|
|
22,925
|
|
|||
Loss on extinguishment of debt
|
|
33,469
|
|
|
—
|
|
|
—
|
|
|||
Other non-cash charges and expenses, net
|
|
30,003
|
|
|
23,690
|
|
|
34,049
|
|
|||
Deferred taxes
|
|
(66,604
|
)
|
|
63,601
|
|
|
(340,156
|
)
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
Increase in Sanofi, Bayer HealthCare, and trade accounts receivable
|
|
(62,432
|
)
|
|
(258,994
|
)
|
|
(588,398
|
)
|
|||
Increase in inventories
|
|
(60,900
|
)
|
|
(47,956
|
)
|
|
(28,932
|
)
|
|||
(Increase) decrease in prepaid expenses and other assets
|
|
(37,767
|
)
|
|
7,571
|
|
|
(25,371
|
)
|
|||
Increase (decrease) in deferred revenue
|
|
19,102
|
|
|
(27,974
|
)
|
|
(41,077
|
)
|
|||
Increase in accounts payable, accrued expenses, and other liabilities
|
|
162,236
|
|
|
136,684
|
|
|
10,979
|
|
|||
Total adjustments
|
|
395,083
|
|
|
159,286
|
|
|
(824,884
|
)
|
|||
Net cash provided by (used in) operating activities
|
|
743,157
|
|
|
583,648
|
|
|
(74,615
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
|
(564,188
|
)
|
|
(577,278
|
)
|
|
(470,945
|
)
|
|||
Sales or maturities of marketable securities
|
|
476,417
|
|
|
378,146
|
|
|
439,209
|
|
|||
Capital expenditures
|
|
(333,006
|
)
|
|
(156,323
|
)
|
|
(49,337
|
)
|
|||
Net cash used in investing activities
|
|
(420,777
|
)
|
|
(355,455
|
)
|
|
(81,073
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||||||
Payments in connection with facility and capital lease obligations
|
|
(1,095
|
)
|
|
(2,024
|
)
|
|
(2,203
|
)
|
|||
Repayments of convertible senior notes
|
|
(220,639
|
)
|
|
—
|
|
|
—
|
|
|||
Payments in connection with reduction of outstanding warrants
|
|
(294,552
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from issuance of Common Stock
|
|
126,045
|
|
|
57,393
|
|
|
63,549
|
|
|||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(267,584
|
)
|
|
(195,087
|
)
|
|
(163,300
|
)
|
|||
Excess tax benefit from stock-based compensation
|
|
448,556
|
|
|
216,857
|
|
|
4,308
|
|
|||
Net cash (used in) provided by financing activities
|
|
(209,269
|
)
|
|
77,139
|
|
|
(97,646
|
)
|
|||
|
|
|
|
|
|
|
||||||
Net increase (decrease) in cash and cash equivalents
|
|
113,111
|
|
|
305,332
|
|
|
(253,334
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at beginning of period
|
|
535,608
|
|
|
230,276
|
|
|
483,610
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at end of period
|
|
$
|
648,719
|
|
|
$
|
535,608
|
|
|
$
|
230,276
|
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest (net of amounts capitalized)
|
|
$
|
20,614
|
|
|
$
|
23,842
|
|
|
$
|
21,946
|
|
Cash paid for income taxes
|
|
$
|
59,847
|
|
|
$
|
1,057
|
|
|
—
|
|
|
|
|
|
|
|
|
|
||||||
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"), macular edema following central retinal vein occlusion ("CRVO"), and diabetic macular edema ("DME"). In addition, EYLEA for the treatment of macular edema following retinal vein occlusion ("RVO"), which includes macular edema following branch retinal vein occlusion ("BRVO"), is available in the United States, and EYLEA for the treatment of myopic choroidal neovascularization ("mCNV") is available in Japan. Bayer HealthCare has additional regulatory applications for various indications pending in other countries. The Company is collaborating with Bayer HealthCare on the global development and commercialization of EYLEA outside the United States. The Company maintains exclusive rights to EYLEA in the United States and is entitled to all profits from such sales.
|
•
|
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"), for patients with metastatic colorectal cancer ("mCRC") that is resistant to or has progressed following an oxaliplatin-containing regimen. 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.
|
•
|
Included in Sanofi collaboration revenue is the Company's share of profits or losses from commercialization of ZALTRAP and commercialization of antibodies, which are provided by Sanofi, and include an estimate of the Company's share of profits or losses for the most recent fiscal quarter.
|
•
|
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 collaborators, Bayer HealthCare and Sanofi, including the Company's share of Bayer HealthCare and Sanofi estimated development expenses for the most recent fiscal quarter.
|
Building and improvements
|
|
10-30 years
|
Laboratory and other equipment
|
|
3-10 years
|
Furniture and fixtures
|
|
5 years
|
|
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
|
|
||||
Provision related to current period sales
|
33,117
|
|
|
77,160
|
|
|
1,578
|
|
|
111,855
|
|
||||
Credits/payments
|
(34,434
|
)
|
|
(75,657
|
)
|
|
(1,584
|
)
|
|
(111,675
|
)
|
||||
Balance as of December 31, 2014
|
$
|
3,083
|
|
|
$
|
21,166
|
|
|
$
|
532
|
|
|
$
|
24,781
|
|
|
|
Year Ended December 31,
|
||||||||||
Sanofi Collaboration Revenue
|
|
2014
|
|
2013
|
|
2012
|
||||||
ZALTRAP:
|
|
|
|
|
|
|
||||||
Regeneron's share of losses in connection with commercialization of ZALTRAP
|
|
$
|
(4,715
|
)
|
|
$
|
(30,810
|
)
|
|
$
|
(25,634
|
)
|
Substantive milestone
|
|
—
|
|
|
—
|
|
|
50,000
|
|
|||
Reimbursement of Regeneron research and development expenses
|
|
4,806
|
|
|
5,639
|
|
|
10,702
|
|
|||
Other
|
|
5,102
|
|
|
9,682
|
|
|
13,268
|
|
|||
Total ZALTRAP
|
|
5,193
|
|
|
(15,489
|
)
|
|
48,336
|
|
|||
Antibody:
|
|
|
|
|
|
|
||||||
Reimbursement of Regeneron research and development expenses
|
|
547,761
|
|
|
453,489
|
|
|
365,245
|
|
|||
Reimbursement of Regeneron commercialization-related expenses
|
|
19,480
|
|
|
1,868
|
|
|
—
|
|
|||
Regeneron's share of losses in connection with commercialization of antibodies
|
|
(41,378
|
)
|
|
—
|
|
|
—
|
|
|||
Up-front payments to Sanofi for acquisition of rights related to two antibodies
|
|
—
|
|
|
(20,000
|
)
|
|
—
|
|
|||
Other
|
|
10,243
|
|
|
10,243
|
|
|
10,233
|
|
|||
Total Antibody
|
|
536,106
|
|
|
445,600
|
|
|
375,478
|
|
|||
|
|
$
|
541,299
|
|
|
$
|
430,111
|
|
|
$
|
423,814
|
|
|
|
Year Ended December 31,
|
||||||||||
Bayer HealthCare Collaboration Revenue
|
|
2014
|
|
2013
|
|
2012
|
||||||
EYLEA:
|
|
|
|
|
|
|
||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
301,302
|
|
|
$
|
101,494
|
|
|
—
|
|
|
Sales and substantive development milestones
|
|
105,000
|
|
|
70,000
|
|
|
$
|
25,000
|
|
||
Cost-sharing of Regeneron EYLEA development expenses
|
|
23,383
|
|
|
20,905
|
|
|
34,892
|
|
|||
Other
|
|
52,390
|
|
|
27,890
|
|
|
10,207
|
|
|||
Total EYLEA
|
|
482,075
|
|
|
220,289
|
|
|
70,099
|
|
|||
PDGFR-beta antibody:
|
|
|
|
|
|
|
||||||
Cost-sharing of REGN2176-3 development expenses
|
|
2,848
|
|
|
—
|
|
|
—
|
|
|||
Other
|
|
10,632
|
|
|
—
|
|
|
—
|
|
|||
Total PDGFR-beta
|
|
13,480
|
|
|
—
|
|
|
—
|
|
|||
|
|
$
|
495,555
|
|
|
$
|
220,289
|
|
|
$
|
70,099
|
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
As of December 31, 2014
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
$
|
548,832
|
|
|
$
|
136
|
|
|
$
|
(1,462
|
)
|
|
$
|
547,506
|
|
U.S. government and government agency obligations
|
|
28,596
|
|
|
3
|
|
|
(46
|
)
|
|
28,553
|
|
||||
Municipal bonds
|
|
37,044
|
|
|
37
|
|
|
(43
|
)
|
|
37,038
|
|
||||
Equity securities
|
|
2,005
|
|
|
5,374
|
|
|
—
|
|
|
7,379
|
|
||||
|
|
616,477
|
|
|
5,550
|
|
|
(1,551
|
)
|
|
620,476
|
|
||||
Restricted
|
|
|
|
|
|
|
|
|
||||||||
Equity securities
|
|
15,000
|
|
|
76,439
|
|
|
—
|
|
|
91,439
|
|
||||
|
|
$
|
631,477
|
|
|
$
|
81,989
|
|
|
$
|
(1,551
|
)
|
|
$
|
711,915
|
|
As of December 31, 2013
|
|
|
|
|
|
|
|
|
||||||||
Unrestricted
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
$
|
369,321
|
|
|
$
|
233
|
|
|
$
|
(361
|
)
|
|
$
|
369,193
|
|
U.S. government and government agency obligations
|
|
107,493
|
|
|
55
|
|
|
(27
|
)
|
|
107,521
|
|
||||
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
|
|
|
|
As of December 31,
|
||||||
|
|
2014
|
|
2013
|
||||
Maturities within one year
|
|
$
|
251,761
|
|
|
$
|
158,376
|
|
Maturities after one year through five years
|
|
360,208
|
|
|
383,410
|
|
||
Maturities after five years through ten years
|
|
1,128
|
|
|
4,138
|
|
||
Maturities after ten years
|
|
—
|
|
|
1,177
|
|
||
|
|
$
|
613,097
|
|
|
$
|
547,101
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||
As of December 31, 2014
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||
Corporate bonds
|
$
|
390,613
|
|
|
$
|
(1,462
|
)
|
|
—
|
|
|
—
|
|
|
$
|
390,613
|
|
|
$
|
(1,462
|
)
|
U.S. government and government agency obligations
|
25,549
|
|
|
(46
|
)
|
|
—
|
|
|
—
|
|
|
25,549
|
|
|
(46
|
)
|
||||
Municipal bonds
|
10,779
|
|
|
(43
|
)
|
|
—
|
|
|
—
|
|
|
10,779
|
|
|
(43
|
)
|
||||
|
$
|
426,941
|
|
|
$
|
(1,551
|
)
|
|
—
|
|
|
—
|
|
|
$
|
426,941
|
|
|
$
|
(1,551
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
As of December 31, 2013
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Corporate bonds
|
$
|
176,140
|
|
|
$
|
(361
|
)
|
|
—
|
|
|
—
|
|
|
$
|
176,140
|
|
|
$
|
(361
|
)
|
U.S. government and government agency obligations
|
49,241
|
|
|
(27
|
)
|
|
—
|
|
|
—
|
|
|
49,241
|
|
|
(27
|
)
|
||||
Municipal bonds
|
14,431
|
|
|
(59
|
)
|
|
—
|
|
|
—
|
|
|
14,431
|
|
|
(59
|
)
|
||||
|
$
|
239,812
|
|
|
$
|
(447
|
)
|
|
—
|
|
|
—
|
|
|
$
|
239,812
|
|
|
$
|
(447
|
)
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||
As of December 31, 2014
|
Fair Value
|
|
Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
Unrestricted
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
547,506
|
|
|
—
|
|
|
$
|
547,506
|
|
|
U.S. government and government agency obligations
|
28,553
|
|
|
—
|
|
|
28,553
|
|
|||
Municipal bonds
|
37,038
|
|
|
—
|
|
|
37,038
|
|
|||
Equity securities
|
7,379
|
|
|
$
|
7,379
|
|
|
—
|
|
||
|
620,476
|
|
|
7,379
|
|
|
613,097
|
|
|||
Restricted
|
|
|
|
|
|
|
|
||||
Equity securities
|
91,439
|
|
|
—
|
|
|
91,439
|
|
|||
|
$
|
711,915
|
|
|
$
|
7,379
|
|
|
$
|
704,536
|
|
|
|
|
|
|
|
||||||
As of December 31, 2013
|
|
|
|
|
|
||||||
Available-for-sale marketable securities:
|
|
|
|
|
|
||||||
Unrestricted
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
369,193
|
|
|
—
|
|
|
$
|
369,193
|
|
|
U.S. government and government agency obligations
|
107,521
|
|
|
—
|
|
|
107,521
|
|
|||
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
|
|
|
As of December 31,
|
||||||
|
2014
|
|
2013
|
||||
Land
|
$
|
2,768
|
|
|
$
|
2,768
|
|
Building and improvements
|
398,981
|
|
|
343,363
|
|
||
Leasehold improvements
|
42,600
|
|
|
26,370
|
|
||
Construction-in-progress
|
472,231
|
|
|
142,370
|
|
||
Laboratory and other equipment
|
253,058
|
|
|
189,543
|
|
||
Furniture, computer and office equipment, and other
|
58,655
|
|
|
44,186
|
|
||
|
1,228,293
|
|
|
748,600
|
|
||
Less, accumulated depreciation and amortization
|
(253,984
|
)
|
|
(221,617
|
)
|
||
|
$
|
974,309
|
|
|
$
|
526,983
|
|
|
As of December 31,
|
||||||
|
2014
|
|
2013
|
||||
Accounts payable
|
$
|
99,508
|
|
|
$
|
61,936
|
|
Accrued payroll and related costs
|
92,778
|
|
|
69,429
|
|
||
Accrued clinical trial expense
|
41,555
|
|
|
23,654
|
|
||
Accrued sales-related charges, deductions, and royalties
|
133,085
|
|
|
66,855
|
|
||
Other accrued expenses and liabilities
|
117,302
|
|
|
29,022
|
|
||
|
$
|
484,228
|
|
|
$
|
250,896
|
|
|
As of December 31,
|
||||||
|
2014
|
|
2013
|
||||
Current portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 4a)
|
$
|
15,927
|
|
|
$
|
12,815
|
|
Received or receivable from Bayer HealthCare (see Note 4b)
|
33,652
|
|
|
9,738
|
|
||
Received for technology license agreement (see Note 5)
|
23,572
|
|
|
23,572
|
|
||
Other
|
874
|
|
|
875
|
|
||
|
$
|
74,025
|
|
|
$
|
47,000
|
|
Long-term portion:
|
|
|
|
||||
Received or receivable from Sanofi (see Note 4a)
|
$
|
72,367
|
|
|
$
|
76,522
|
|
Received or receivable from Bayer HealthCare (see Note 4b)
|
46,486
|
|
|
26,683
|
|
||
Received for technology license agreement (see Note 5)
|
57,423
|
|
|
80,994
|
|
||
|
$
|
176,276
|
|
|
$
|
184,199
|
|
|
|
As of December 31,
|
||||||
|
|
2014
|
|
2013
|
||||
Total convertible senior notes - par
|
|
$
|
169,400
|
|
|
$
|
400,000
|
|
Unamortized discount
|
|
(22,627
|
)
|
|
(79,685
|
)
|
||
|
|
$
|
146,773
|
|
|
$
|
320,315
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Contractual coupon interest rate
|
|
$
|
5,036
|
|
|
$
|
7,230
|
|
|
$
|
7,503
|
|
Amortization of discount and note issuance costs
|
|
17,821
|
|
|
22,980
|
|
|
21,623
|
|
|||
|
|
$
|
22,857
|
|
|
$
|
30,210
|
|
|
$
|
29,126
|
|
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2015
|
|
$
|
9,370
|
|
|
$
|
1,449
|
|
|
$
|
10,819
|
|
2016
|
|
10,040
|
|
|
151
|
|
|
10,191
|
|
|||
2017
|
|
9,592
|
|
|
13
|
|
|
9,605
|
|
|||
2018
|
|
9,779
|
|
|
—
|
|
|
9,779
|
|
|||
2019
|
|
9,957
|
|
|
—
|
|
|
9,957
|
|
|||
Thereafter
|
|
58,271
|
|
|
—
|
|
|
58,271
|
|
|||
|
|
$
|
107,009
|
|
|
$
|
1,613
|
|
|
$
|
108,622
|
|
Year Ended December 31,
|
|
Facilities
|
|
Equipment
|
|
Total
|
||||||
2014
|
|
$
|
13,360
|
|
|
$
|
952
|
|
|
$
|
14,312
|
|
2013
|
|
9,404
|
|
|
471
|
|
|
9,875
|
|
|||
2012
|
|
7,428
|
|
|
601
|
|
|
8,029
|
|
|
|
Buildings A and B
|
|
Building C
|
|
Total
|
||||||
2015
|
|
$
|
13,545
|
|
|
$
|
4,562
|
|
|
$
|
18,107
|
|
2016
|
|
13,809
|
|
|
4,688
|
|
|
18,497
|
|
|||
2017
|
|
14,079
|
|
|
4,818
|
|
|
18,897
|
|
|||
2018
|
|
14,356
|
|
|
4,951
|
|
|
19,307
|
|
|||
2019
|
|
14,640
|
|
|
5,088
|
|
|
19,728
|
|
|||
Thereafter
|
|
132,027
|
|
|
59,987
|
|
|
192,014
|
|
|||
|
|
$
|
202,456
|
|
|
$
|
84,094
|
|
|
$
|
286,550
|
|
a.
|
Stock Options
|
Stock Options:
|
|
Number of Shares
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term (in years)
|
|
Intrinsic Value (in thousands)
|
||||||
Outstanding as of December 31, 2013
|
|
21,408,268
|
|
|
$
|
98.10
|
|
|
|
|
|
|||
2014:
|
Granted
|
|
3,913,368
|
|
|
$
|
385.33
|
|
|
|
|
|
||
|
Forfeited
|
|
(252,126
|
)
|
|
$
|
155.37
|
|
|
|
|
|
||
|
Expired
|
|
(350
|
)
|
|
$
|
64.35
|
|
|
|
|
|
||
|
Exercised
|
|
(3,562,900
|
)
|
|
$
|
44.72
|
|
|
|
|
|
||
Outstanding as of December 31, 2014
|
|
21,506,260
|
|
|
$
|
158.54
|
|
|
6.99
|
|
$
|
5,467,783
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vested and expected to vest as of December 31, 2014
|
|
20,988,044
|
|
|
$
|
154.81
|
|
|
6.94
|
|
$
|
5,414,258
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercisable as of December 31, 2014
|
|
12,104,560
|
|
|
$
|
65.48
|
|
|
5.53
|
|
$
|
4,203,941
|
|
|
|
Number of Options Granted
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Fair Value
|
|||||
2014:
|
|
|
|
|
|
|
|||||
Exercise price equal to Market Price
|
|
3,913,368
|
|
|
$
|
385.33
|
|
|
$
|
140.38
|
|
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
|
|
|
|
2014
|
|
2013
|
|
2012
|
|||
Expected volatility
|
|
39
|
%
|
|
42
|
%
|
|
45
|
%
|
Expected lives from grant date
|
|
5.2 years
|
|
|
5.3 years
|
|
|
5.4 years
|
|
Expected dividend yield
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk-free interest rate
|
|
1.62
|
%
|
|
1.73
|
%
|
|
0.86
|
%
|
b.
|
Restricted Stock
|
Restricted Stock:
|
|
Number of Shares
|
|
Weighted-Average Grant Date Fair Value
|
||||
Outstanding as of December 31, 2013
|
|
538,580
|
|
|
$
|
112.16
|
|
|
2014:
|
Granted
|
|
7,500
|
|
|
$
|
338.32
|
|
|
Vested
|
|
(20
|
)
|
|
$
|
237.68
|
|
Outstanding as of December 31, 2014
|
|
546,060
|
|
|
$
|
115.26
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Current:
|
|
|
|
|
|
|||||||
|
Federal
|
$
|
447,370
|
|
|
$
|
201,475
|
|
|
—
|
|
|
|
State
|
28,718
|
|
|
23,489
|
|
|
$
|
4,308
|
|
||
|
Foreign
|
2,879
|
|
|
433
|
|
|
—
|
|
|||
|
Total current tax expense (benefit)
|
478,967
|
|
|
225,397
|
|
|
4,308
|
|
|||
Deferred:
|
|
|
|
|
|
|||||||
|
Federal
|
(68,700
|
)
|
|
54,910
|
|
|
(300,319
|
)
|
|||
|
State
|
18,891
|
|
|
8,700
|
|
|
(39,837
|
)
|
|||
|
Foreign
|
(1,485
|
)
|
|
(9
|
)
|
|
—
|
|
|||
|
Total deferred tax expense (benefit)
|
(51,294
|
)
|
|
63,601
|
|
|
(340,156
|
)
|
|||
|
$
|
427,673
|
|
|
$
|
288,998
|
|
|
$
|
(335,848
|
)
|
|
Year Ended December 31,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
U.S. federal statutory tax rate
|
35.0
|
%
|
|
35.0
|
%
|
|
35.0
|
%
|
State and local income taxes
|
2.0
|
|
|
3.4
|
|
|
5.4
|
|
Change in state effective rate
|
2.8
|
|
|
—
|
|
|
5.4
|
|
Foreign income tax rate differential
|
15.3
|
|
|
4.9
|
|
|
—
|
|
Income tax credits
|
(7.4
|
)
|
|
(4.9
|
)
|
|
—
|
|
Reclassification of net operating losses related to exercises of stock options
|
—
|
|
|
—
|
|
|
9.3
|
|
Provision (benefit) attributable to valuation allowances
|
—
|
|
|
—
|
|
|
(139.0
|
)
|
Provision (benefit) related to uncertain tax positions
|
2.5
|
|
|
—
|
|
|
—
|
|
Non-deductible Branded Prescription Drug Fee
|
2.7
|
|
|
1.1
|
|
|
—
|
|
Other permanent differences
|
2.2
|
|
|
1.0
|
|
|
2.8
|
|
Effective income tax rate
|
55.1
|
%
|
|
40.5
|
%
|
|
(81.1
|
)%
|
|
|
As of December 31,
|
||||||
|
|
2014
|
|
2013
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating loss carry-forward
|
|
$
|
150
|
|
|
$
|
135
|
|
Fixed assets
|
|
8,078
|
|
|
18,902
|
|
||
Deferred revenue
|
|
75,503
|
|
|
88,033
|
|
||
Deferred compensation
|
|
194,489
|
|
|
109,715
|
|
||
Income tax credit carry-forwards
|
|
16,099
|
|
|
9,372
|
|
||
Capitalized research and development costs
|
|
12,908
|
|
|
18,942
|
|
||
Other
|
|
41,252
|
|
|
34,215
|
|
||
|
|
348,479
|
|
|
279,314
|
|
||
Valuation allowance
|
|
(359
|
)
|
|
(1,830
|
)
|
||
Total deferred tax assets
|
|
348,120
|
|
|
277,484
|
|
||
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
|
||||
Unrealized gains/losses on marketable securities
|
|
(28,186
|
)
|
|
—
|
|
||
Convertible senior notes
|
|
(252
|
)
|
|
(929
|
)
|
||
Other
|
|
(3,578
|
)
|
|
—
|
|
||
|
|
(32,016
|
)
|
|
(929
|
)
|
||
Net deferred tax assets
|
|
$
|
316,104
|
|
|
$
|
276,555
|
|
|
|
2014
|
|
2013
|
|
2012
|
||||||
Balance as of January 1
|
|
$
|
26,627
|
|
|
$
|
11,274
|
|
|
$
|
5,596
|
|
Gross increases related to current year tax positions
|
|
27,538
|
|
|
7,620
|
|
|
1,873
|
|
|||
Gross increases related to prior year tax positions
|
|
6,464
|
|
|
8,305
|
|
|
3,805
|
|
|||
Gross decrease due to settlements, recapture, filed returns, and lapse of statutes of limitation
|
|
(3,014
|
)
|
|
(572
|
)
|
|
—
|
|
|||
Balance as of December 31
|
|
$
|
57,615
|
|
|
$
|
26,627
|
|
|
$
|
11,274
|
|
|
|
December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Net income - basic
|
|
$
|
348,074
|
|
|
$
|
424,362
|
|
|
$
|
750,269
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Convertible senior notes - interest expense related to contractual coupon interest rate and amortization of discount and note issuance costs
|
|
—
|
|
|
—
|
|
|
29,126
|
|
|||
Net income - diluted
|
|
$
|
348,074
|
|
|
$
|
424,362
|
|
|
$
|
779,395
|
|
|
|
|
|
|
|
|
||||||
(Shares in thousands)
|
|
|
|
|
|
|
||||||
Weighted average shares - basic
|
|
100,612
|
|
|
97,917
|
|
|
94,685
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
||||||
Stock options
|
|
9,440
|
|
|
10,233
|
|
|
14,231
|
|
|||
Restricted stock
|
|
425
|
|
|
433
|
|
|
715
|
|
|||
Convertible senior notes
|
|
—
|
|
|
—
|
|
|
4,761
|
|
|||
Warrants
|
|
2,936
|
|
|
2,707
|
|
|
990
|
|
|||
Dilutive potential shares
|
|
12,801
|
|
|
13,373
|
|
|
20,697
|
|
|||
Weighted average shares - diluted
|
|
113,413
|
|
|
111,290
|
|
|
115,382
|
|
|||
|
|
|
|
|
|
|
||||||
Net income per share - basic
|
|
$
|
3.46
|
|
|
$
|
4.33
|
|
|
$
|
7.92
|
|
Net income per share - diluted
|
|
$
|
3.07
|
|
|
$
|
3.81
|
|
|
$
|
6.75
|
|
|
|
December 31,
|
|||||||
(Shares in thousands)
|
|
2014
|
|
2013
|
|
2012
|
|||
Stock options
|
|
1,470
|
|
|
304
|
|
|
325
|
|
Convertible senior notes
|
|
4,247
|
|
|
4,761
|
|
|
—
|
|
|
|
First Quarter Ended
March 31, 2014
|
|
Second Quarter Ended
June 30, 2014
|
|
Third Quarter Ended
September 30, 2014
|
|
Fourth Quarter Ended
December 31, 2014
|
||||||||
|
|
(Unaudited)
|
||||||||||||||
Revenues
(1)
|
|
$
|
625,740
|
|
|
$
|
665,700
|
|
|
$
|
725,788
|
|
|
$
|
802,329
|
|
Net income
(2)
|
|
$
|
65,443
|
|
|
$
|
92,735
|
|
|
$
|
79,720
|
|
|
$
|
110,176
|
|
Net income per share - basic
|
|
$
|
0.66
|
|
|
$
|
0.92
|
|
|
$
|
0.79
|
|
|
$
|
1.09
|
|
Net income per share - diluted
|
|
$
|
0.58
|
|
|
$
|
0.82
|
|
|
$
|
0.70
|
|
|
$
|
0.96
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
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
(3)
|
|
$
|
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
|
|
1.
|
Existing Definitions.
Capitalized terms used in this Amendment Agreement which are not defined herein and are defined in the LCA shall have the meanings ascribed to them in the LCA. Capitalized terms used in this Amendment Agreement which are not defined herein and are not defined in the LCA shall have the meanings ascribed to them in the Santen Co-Promotion Agreement and such definitions are hereby deemed incorporated by reference into Article I of the LCA.
|
2.
|
New Definitions.
Article 1 of the LCA is hereby amended to add the following definitions:
|
(a)
|
“
[****]
” shall mean [****].
|
(b)
|
“
Amendment Agreement
” shall mean this Amendment Agreement, as it may be amended from time to time.
|
(c)
|
“
Bayer Market Net Sales
” shall mean Net Sales in Japan calculated in accordance with the definition of Net Sales set forth in Article I of the LCA.
|
(d)
|
“
Bayer Sales
” shall mean the number of units of Licensed Product sold by Bayer to Santen during the respective Quarter multiplied by [****] and multiplied by [****].
|
(e)
|
“
BYL
” shall mean Bayer Yakuhin Ltd., an Affiliate of Company.
|
(f)
|
“
Japan Profit Share
” shall have the meaning, and shall be calculated as, set forth in Schedule 2, Section I.B.
|
(g)
|
“
Japan Purchase Price Adjustment
” shall have the meaning, and shall be calculated as, set forth in Schedule 2, Section I.A.
|
(h)
|
“
Japan Shared Promotion Expenses
” shall have the meaning set forth in Schedule 2, Section I.B.(i).
|
(i)
|
“
Santen
” shall mean Santen Pharmaceutical Co., Ltd., a Japanese corporation having its principal place of business at 3-9-19, Shimoshinjo, Higashiyodogawa-ku, Osaka 533-8651, Japan.
|
(j)
|
“
Santen Change of Control
” shall mean any of the following events: (a) Company or any of its Affiliates, alone or together, acquire(s) shares of capital stock of Santen representing a majority of the total voting power represented by all classes of capital stock then outstanding of Santen normally entitled to vote in the election of members of the board of directors (or analogous governing body) of Santen; (b) Santen consolidates with or merges with or into Company or any of its Affiliates; or (c) Santen conveys, transfers or leases all or substantially all of its assets to Company or any of its Affiliates.
|
(k)
|
“
Santen Co-Promotion Agreement
” shall mean the Co-Promotion and Distribution Agreement dated of even date herewith by and between BYL and Santen, as amended from time to time in accordance with the terms thereof and with the consent of Regeneron if required pursuant to the Amendment Agreement.
|
(l)
|
“
Santen Market Net Sales
” shall mean the number of units of Licensed Product sold by Santen to wholesalers or other Third Parties during the respective Quarter multiplied by [****] and multiplied by[****].
|
3.
|
Amended Definitions.
The following definitions in Article I of or elsewhere in the LCA are hereby amended as follows:
|
(a)
|
References in the LCA to “Agreement” shall mean the LCA, as amended by this Amendment Agreement.
|
(b)
|
“
Consolidated Payment Report
”. The definition of “Consolidated Payment Report” set forth in Article I of the LCA is amended by adding the following sentence at the end thereof: "In addition, the Consolidated Payment Report shall also include for such Quarter (i) if the Santen Co-Promotion Agreement is in effect and the Japan Purchase Price Adjustment is applicable for such Quarter and, in accordance with Schedule 2, is calculated based on Santen Market Net Sales, (A) Santen Market Net Sales, (B) the applicable NHI Price and (C) unit sales of the Licensed Product in Japan, (ii) if the Japan Purchase Price Adjustment is applicable for such Quarter and is calculated based on Bayer Market Net Sales in accordance with Schedule 2, Bayer Market Net Sales, and (iii) if the Santen Co-Promotion Agreement is in effect and the Japan Profit Share is applicable for such Quarter, (A) Bayer Sales, (B) COGS applicable to Bayer Sales and (C) Japan Shared Promotion Expenses incurred by BYL (following reconciliation with Santen) and by Regeneron, if any."
|
(c)
|
“
Net Sales
”. The definition of “Net Sales” set forth in Article I of the LCA is amended by adding the following sentence at the end thereof: “So long as the Santen Co-Promotion Agreement remains in effect, Net Sales excludes sales of Licensed Products in the Field in Japan.”
|
(d)
|
“
Shared Promotion Expenses
”. The definition of “Shared Promotion Expenses” in Article I of the LCA is amended by adding the following sentence at the end thereof: “So long as the Santen Co-Promotion Agreement is in effect, Shared Promotion Expenses excludes any of the items listed in this definition to the extent related to the Commercialization of Licensed Products in Japan.”
|
4.
|
Schedule 2.
Schedule 2 of the LCA is deleted in its entirety and replaced with the Amended and Restated Schedule 2 attached to this Amendment Agreement, and all references to Schedule 2 in this Amendment Agreement, or in the LCA from and after the date of this Amendment Agreement, refer to such Amended and Restated Schedule 2.
|
5.
|
Regeneron Consent to Sublicense Grant
. Regeneron hereby expressly agrees and consents for the Initial Term to a sublicense by BHC to BYL of BHC’s rights under the Regeneron Intellectual Property granted by Regeneron to BHC pursuant to the LCA, provided such sublicense is in compliance with Section 4.3 of the LCA unless agreed in writing by Regeneron with BHC, and to BYL’s further sublicense of such rights to Santen, to the extent that they comprise Licensed Intellectual Property, pursuant to the terms of the Santen Co-Promotion Agreement, provided that such agreement and consent shall not alter or affect in any manner BHC’s obligations or Regeneron’s rights under the
|
6.
|
Commercialization Governance
. For so long as the Santen Co-Promotion Agreement remains in effect, all management and governance of the Commercialization efforts for the Licensed Product in Japan shall be determined under the LCA as if such efforts were conducted by Company alone (it being understood that for so long as the Santen Co-Promotion Agreement remains in effect, Company may fulfill its obligations under the first two sentences of Section 6.6 and Section 6.7 of the LCA through Santen), except that Regeneron shall not participate in the Joint Steering Committee (as defined in the Santen Co-Promotion Agreement) for Japan. For the avoidance of doubt, Company must still prepare and present to the JCC the Country Commercialization Plan for Japan in accordance with Section 6.3 of the LCA. If the Santen Co-Promotion Agreement is no longer in effect, this Section 6 of this Amendment shall have no further force or effect and the management and governance of the Commercialization efforts for the Licensed Product in Japan shall again be governed by and subject to the LCA in all respects. Company shall provide to Regeneron, within ten (10) Business Days of receipt, all reports and information provided to BYL or Company under Section 3.3 of the Santen Co-Promotion Agreement. Notwithstanding anything to the contrary in this Section 6, Company shall provide, or shall cause BYL to provide, to Regeneron such other reports and information required to be provided under the LCA in the form required by the LCA.
|
7.
|
Section 9.3(f)
. Section 9.3(f) of the LCA is amended by adding the following at the end thereof: “provided, that if the Santen Co-Promotion Agreement is in effect and the Japan Profit Share is applicable, within forty-five (45) days following the end of each Quarter commencing after the First Commercial Sale in Japan (or such earlier agreed upon calendar Quarter, if appropriate), each Party that has (or whose Affiliate has) incurred Japan Shared Promotion Expenses in that Quarter shall deliver electronically to the other Party a written report setting forth in reasonable detail the Japan Shared Promotion Expenses incurred by that Party or its Affiliates in such Quarter”.
|
8.
|
Section 9.3(g)
. Section 9.3(g) of the LCA is amended by adding immediately after the words “for such Quarter” the following: “and, if the Santen Co-Promotion Agreement is in effect and the Japan Profit Share is applicable, Company shall deliver electronically to Regeneron a written report setting forth (i) COGS applicable to Bayer Sales and (ii) COGS incurred by Company or its Affiliates applicable to Net Sales in the Territory excluding Japan”.
|
9.
|
Section 11.6.
Section 11.6 of the LCA is amended by adding the following at the end of the first sentence of such Section (after the word “materials” and before the period): “;and provided further that if including Regeneron’s name with equal prominence on materials exclusively related to each Licensed Product in the Field as provided above is prohibited under applicable Laws, Company will use Commercially Reasonable Efforts to include, to the extent permitted by applicable Laws, a reference to Regeneron and its
|
10.
|
Calculation of the Japan Profit Split
. Unless the Japan Profit Share is applicable as provided in Section 11 or Section 12 of this Amendment Agreement, the Japan Profit Split (as defined in Schedule 2, Section I.) shall be calculated as the Japan Purchase Price Adjustment, as defined in and in accordance with Schedule 2, Section I.A.
|
11.
|
Bayer Renegotiation Option
. If the actual [****] in a given calendar year is less than [****] of the Assumed [****] for such calendar year as set forth in the table in Schedule 2A attached to this Amendment Agreement, either Party may request in writing that the Japan Purchase Price Adjustment set forth in Schedule 2, Section I.A., be renegotiated to reflect the changed circumstances and to restore the economic basis of such financial arrangements. The Parties agree to renegotiate in good faith for thirty (30) days following the written request by a Party for renegotiation of such Japan Purchase Price Adjustment pursuant to this Section 11. If the Parties do not reach written agreement on adjustments to the Japan Purchase Price Adjustment within such thirty (30)- day period, the Japan Profit Split (as defined in Schedule 2, Section I.) shall thereafter be the Japan Profit Share, as defined in and calculated in accordance with Schedule 2, Section I.B., beginning in the next calendar Quarter commencing on or after the expiration of the thirty (30)-day period referenced above in this Section 11.
|
12.
|
Launch Delay Option
. In the event that the First Commercial Sale of a Licensed Product in Japan occurs after [****], either Party may request in writing that the schedule of annual Baseline A Santen Market Net Sales forth in Schedule 2, Section I.A., and, if the delay materially adversely affects the economic basis of the financial arrangements regarding the Commercialization of Licensed Products in Japan provided for in this Amendment Agreement (including Schedule 2), the Japan Purchase Price Adjustment, be renegotiated to reflect the delayed launch date and to restore the economic basis of such financial arrangements. The Parties agree to renegotiate in good faith for thirty (30) days following such a written request. If the Parties do not reach written agreement on a revised schedule of Baseline A Santen Market Net Sales and, if applicable, revised Japan Purchase Price Adjustment, within such thirty (30)-day period, the Japan Profit Split (as defined in Schedule 2, Section I.) shall thereafter be the Japan Profit Share, as defined in and calculated in accordance with Schedule 2, Section I.B., beginning in the next calendar Quarter commencing on or after the expiration of the thirty (30)-day period referenced above in this Section 12. If the schedule of Baseline A Santen Market Net Sales is adjusted, the schedule of Baseline B and Baseline C Santen Market Net Sales will also be adjusted proportionately.
|
13.
|
[****]
.
|
14.
|
Calculation of Sales Milestones Payments
. For so long as the Santen Co-Promotion Agreement is in effect, Santen Market Net Sales shall be added to Net Sales in calculating aggregate Net Sales for purposes of determining the achievement of the sales milestone events described on Schedule 3 to the LCA. If the Santen Co-Promotion Agreement is no longer in effect, Bayer Market Net Sales shall be utilized in calculating aggregate Net Sales for such purposes.
|
15.
|
Restrictions on BYL Actions under Santen Co-Promotion Agreement
.
|
(a)
|
Company will not, and will ensure that BYL does not, without Regeneron's prior written consent (such consent regarding subparagraphs (ii) and (iv) below not to be unreasonably withheld, delayed or conditioned):
|
(i)
|
Agree to any amendment or modification of, waive or fail to enforce any material rights or grant any consent or approval under (including without limitation to permit Santen to conduct any Non-Approval Trial related to the Licensed Product in Japan), extend the Initial Term of, or terminate in part, the Santen Co-Promotion Agreement;
|
(ii)
|
Agree to or permit any Public Relations Activity related to the Licensed Product in Japan;
|
(iii)
|
Agree to or permit any reduction in the Minimum Audited Detail, or any downward revision in the Market Share Target percentage;
|
(iv)
|
Enter into or thereafter amend any of the agreements referred to in Section 6.2 or 7.13 of the Santen Co-Promotion Agreement;
|
(v)
|
Accept Santen's rejection of any delivery of Licensed Product if such rejection is based on actions or omissions of Regeneron in connection with the Manufacture of such Licensed Product, unless Regeneron has confirmed in writing the basis for such rejection in its reasonable judgment prior to such acceptance. For the avoidance of doubt, neither Santen nor BYL shall be required to introduce to the market or keep on the market any Licensed Product that they have tendered for rejection;
|
(vi)
|
Resolve or agree to resolve any dispute under the Santen Co-Promotion Agreement if such resolution would diminish the economic benefit reasonably expected to accrue to Regeneron pursuant to the Japan Purchase Price Adjustment or Japan Profit Split, as applicable, or would adversely affect the Collaboration in the Territory outside Japan; or
|
(vii)
|
Agree, pursuant to Section 7.11 of the Santen Co-Promotion Agreement, on an extension of the Minimum Remaining Shelf-Life of the Licensed Product to be delivered to Santen.
|
(b)
|
If BYL is entitled to terminate the Santen Co-Promotion Agreement, Company and BYL will consult with Regeneron regarding the advisability of such termination, but BYL will have the ultimate decision on whether to terminate. Upon such termination, the Existing LCA, as amended by this Amendment Agreement, will govern Commercialization of the Licensed Product in Japan.
|
(c)
|
For so long as the Santen Co-Promotion Agreement is in effect, Company will not and will ensure that BYL does not make any sales of Licensed Products in Japan. The foregoing does not apply to sales of Licensed Product by Company or BYL to Santen as contemplated by the Santen Co-Promotion Agreement, or any other Commercialization activities expressly provided in the Santen Co-Promotion Agreement to be performed by Company or BYL.
|
16.
|
Supply Chain
. Notwithstanding the obligations set forth in the Santen Co-Promotion Agreement, Company and BYL will maintain a minimum inventory of [****] of work-in-process inventory of Licensed Product allocated for Japan for the first [****] following the First Commercial Sale in Japan, and thereafter, a minimum inventory of [****] of work-in-process inventory of Licensed Product allocated for Japan. The foregoing requirements shall be reviewed by the parties in good faith if [****]. For purposes of this paragraph 16, “work in progress inventory” shall mean Licensed Product in vials or syringes prior to labeling or blistering, filled vials or syringes of Licensed Product that are labeled or blistered prior to sterilization, or sterilized and filled vials or blisters of Licensed Product that are labeled or blistered prior to packaging.
|
17.
|
Public Announcement
. The Company and Regeneron will mutually agree upon the contents of any press release regarding the Santen Co-Promotion Agreement and this Amendment Agreement. Any other press release or public announcement concerning the Santen Co-Promotion Agreement or this Amendment Agreement shall be governed by Section 16.4 of the LCA. To the extent that a Party concludes in good faith that it is or may be required to file or register this Amendment Agreement or a notification thereof with any Governmental Authority in accordance with applicable Laws, such Party may do so subject to the provisions of Sections 16.4 and 20.8 of the LCA.
|
18.
|
Continuing Effect.
Except as specifically modified by this Amendment Agreement, all of the provisions of the LCA are hereby ratified and confirmed to be in full force and effect, and shall remain in full force and effect.
|
19.
|
Company Representation; Performance by BYL.
Company hereby represents and warrants to Regeneron that neither Company, BYL nor any of their Affiliates doing business principally in Japan has any current or planned agreement, arrangement or understanding with Santen or any of its Affiliates, other than the Santen Co-Promotion Agreement. Company shall
cause BYL to perform all its obligations under the Santen Co-Promotion Agreement and will notify Regeneron if it or any of its Affiliates enters into any such agreement, arrangement or understanding with Santen or any of its Affiliates, other than the Santen Co-Promotion Agreement.
For the avoidance of doubt, the foregoing representation and warranty, and the requirement to notify Regeneron, does
|
20.
|
No Offset.
For the avoidance of doubt, Bayer will have no right to offset the Japan Purchase Price Adjustment with any Bayer COGS, Shared Promotion Expenses or Japan Shared Promotion Expenses, as defined in Schedule 2, Section I.B.(i).
|
21.
|
Entire Agreement; Successors and Assigns.
The LCA, this Amendment Agreement, and any written agreements executed by both Parties pertaining to the subject matter therein or herein, contain the complete understanding and entire agreement of the Parties hereto with respect to subject matter hereof and thereof and said documents supersede all prior understandings and agreements, whether written or oral, relating to the subject matter hereof and thereof. This Amendment Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.
|
22.
|
Headings.
Headings in this Amendment Agreement are for convenience of reference only and shall not be considered in construing this Amendment Agreement.
|
23.
|
Counterparts.
This Amendment Agreement may be executed in counterparts and by facsimile signatures, each of which shall be deemed an original, and shall become a binding agreement when one or more counterparts have been signed by each Party and delivered to the other Party.
|
24.
|
Miscellaneous.
The provisions of Section 20.1 of the LCA shall apply, mutatis mutandis, to this Amendment Agreement. If there is a direct conflict between the provisions of the LCA and this Amendment Agreement, this Amendment Agreement shall govern. This Amendment Agreement may be amended only by a writing executed by an authorized representative of each of the Parties.
|
|
Aggregate
|
Company
|
Regeneron
|
|
|
|
|
|
|
Net Sales in the Territory*
|
1000
|
1000
|
|
|
|
|
|
|
|
COGS*
|
(50)
|
(50)
|
0
|
|
|
|
|
|
|
Shared Promotion Expenses*
|
(350)
|
(300)
|
(50)
|
|
|
|
|
|
|
Territory Profits
|
600
|
|
|
|
50% of Territory Profits
|
300
|
|
|
|
Japan Profit Split
|
100
|
|
|
|
Territory Profit Split
|
400
|
|
|
|
A.
|
JAPAN PURCHASE PRICE ADJUSTMENT
|
|
Santen Market Net Sales
(in millions of Yen) |
|
||
Year
|
Baseline A
|
Baseline B
(=[****] of Baseline A) |
Baseline C
(=[****] of Baseline A) |
|
2012
|
[****]
|
[****]
|
[****]
|
|
2013
|
[****]
|
[****]
|
[****]
|
|
2014
|
[****]
|
[****]
|
[****]
|
|
2015
|
[****]
|
[****]
|
[****]
|
|
2016
|
[****]
|
[****]
|
[****]
|
|
2017
|
[****]
|
[****]
|
[****]
|
|
2018
|
[****]
|
[****]
|
[****]
|
|
2019
|
[****]
|
[****]
|
[****]
|
|
2020
|
[****]
|
[****]
|
[****]
|
|
2021
|
[****]
|
[****]
|
[****]
|
|
|
|
Aggregate
|
|
Company
|
|
Regeneron
|
Global True-Up
|
||||
Development Costs under Global Development Plan
|
|
80
|
|
|
30
|
|
|
50
|
|
|
|
Other Shared Expenses
|
|
40
|
|
|
35
|
|
|
5
|
|
|
|
Total
|
|
120
|
|
|
65
|
|
|
55
|
|
(5
|
)
|
Territory Profit Split
|
|
400
|
|
Global Development Balance
|
|
200
|
|
[****]
|
|
[****]
|
|
Global Development Balance Payment
|
|
[****]
|
|
Territory Profit Split
|
|
400
|
|
Regeneron Reimbursement Amount
|
|
65
|
|
Global True-Up
|
|
(5
|
)
|
[****]
|
|
[****]
|
|
Quarterly True-up
|
|
[****]
|
|
Year
|
Assumed [****]
|
2012
|
[****]
|
2013
|
[****]
|
2014
|
[****]
|
2015
|
[****]
|
2016
|
[****]
|
2017
|
[****]
|
2018
|
[****]
|
2019
|
[****]
|
2020
|
[****]
|
2021
|
[****]
|
2022
|
[****]
|
2023
|
[****]
|
2024
|
[****]
|
2025
|
[****]
|
2026 and thereafter
|
[****]
|
To:
|
Regeneron Pharmaceuticals, Inc.
|
Attention:
|
Dominick Agron
|
Facsimile:
|
(914) 847-1555
|
From:
|
Goldman, Sachs & Co.
|
Re:
|
Second Amendment of the Warrant Transaction between Goldman, Sachs & Co. and Regeneron Pharmaceuticals, Inc.
|
Applicable Number of Warrants:
|
To be in the aggregate a number of Warrants as determined by GS&Co. with respect to which GS&Co. has closed out its Hedge Positions during the Unwind Period (as defined below);
provided
that the Applicable Number of Warrants shall not exceed the Maximum Number of Warrants (as defined below).
|
Maximum Number of Warrants:
|
493,229
|
per Warrant:
|
As set forth in Annex A, to be the amount specified for the relevant Unwind Period Price.
|
Payment Amount:
|
USD $148,500,000.
|
Payment Date:
|
The third Currency Business Day following the last day of the Unwind Period.
|
Unwind Period:
|
A number of Scheduled Trading Days selected by GS&Co. in its sole discretion, beginning on the Scheduled Trading Day immediately following the date hereof, and ending no later than February 12, 2015.
|
Unwind Period Price:
|
The volume-weighted average of the per Share prices at which GS&Co. purchases Shares in order to close out its Hedge Positions in respect of the Applicable Number of Warrants during the Unwind Period;
provided
that GS&Co. shall not effect any such purchases at a price per Share in excess of the Limit Price.
|
Limit Price:
|
USD $397.75 per Share.
|
Unwind Period Price
|
Amendment Payment Amount per Warrant
|
$370.00
|
$273.46
|
$375.00
|
$278.44
|
$380.00
|
$283.43
|
$385.00
|
$288.41
|
$390.00
|
$293.40
|
$395.00
|
$298.38
|
$397.75
|
$301.07
|
To:
|
Regeneron Pharmaceuticals, Inc.
|
Attention:
|
Dominick Agron
|
Facsimile:
|
(914) 847-5892
|
From:
|
Credit Suisse Capital LLC
|
Re:
|
Second Amendment of the Warrant Transaction between Credit Suisse Capital LLC and Regeneron Pharmaceuticals, Inc.
|
|
|
To:
|
Regeneron Pharmaceuticals, Inc.
|
Attention:
|
Dominick Agron
|
Facsimile:
|
(914) 847-5892
|
From:
|
Credit Suisse Capital LLC
|
Re:
|
Third Amendment of the Warrant Transaction between Credit Suisse Capital LLC and Regeneron Pharmaceuticals, Inc.
|
|
|
|
Name of Subsidiary*
|
|
State or Other Jurisdiction of Incorporation or Organization
|
|
OSMR Holdings
|
|
Bermuda
|
|
OSMR International
|
|
Bermuda
|
|
Regeneron Capital International B.V.
|
|
The Netherlands
|
|
Regeneron Genetics Center LLC
|
|
Delaware
|
|
Regeneron Healthcare Solutions, Inc.
|
|
New York
|
|
Regeneron International
|
|
Ireland
|
|
Regeneron International Holdings LLC
|
|
Delaware
|
|
Regeneron Ireland
|
|
Ireland
|
|
Regeneron Ireland Holdings
|
|
Ireland
|
|
Regeneron UK Limited
|
|
United Kingdom
|
|
|
|
|
|
_____________
|
|
|
|
* 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 12, 2015
|
/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):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date:
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February 12, 2015
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/s/ Robert E. Landry
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Robert E. Landry
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Senior Vice President, Finance and Chief Financial Officer
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(Principal Financial Officer)
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(1)
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Leonard S. Schleifer
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Leonard S. Schleifer, M.D., Ph.D.
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President and Chief Executive Officer
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(Principal Executive Officer)
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February 12, 2015
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/s/ Robert E. Landry
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Robert E. Landry
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Senior Vice President, Finance and Chief Financial Officer
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(Principal Financial Officer)
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February 12, 2015
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