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Collaboration Agreements (Notes)
6 Months Ended
Jun. 30, 2017
Collaboration Agreement [Abstract]  
Collaboration Agreements
Collaboration Agreements
a. Sanofi
The collaboration revenue the Company earned from Sanofi is detailed below:
 
 
Three Months Ended
June 30,
 
Six Months Ended
June 30,
Sanofi Collaboration Revenue
 
2017
 
2016
 
2017
 
2016
Antibody:
 
 
 
 
 
 
 
 
Reimbursement of Regeneron research and development expenses
 
$
137,272

 
$
144,232

 
$
292,517

 
$
337,834

Reimbursement of Regeneron commercialization-related expenses
 
87,104

 
80,817

 
160,663

 
149,539

Regeneron's share of losses in connection with commercialization of antibodies
 
(122,281
)
 
(122,107
)
 
(230,683
)
 
(221,529
)
Other
 
31,204

 
8,122

 
42,490

 
15,639

Total Antibody
 
133,299

 
111,064

 
264,987

 
281,483

Immuno-oncology:
 
 
 
 
 
 
 
 
Reimbursement of Regeneron research and development expenses
 
68,080

 
32,350

 
126,759

 
61,625

Other
 
20,749

 
20,000

 
40,749

 
40,000

Total Immuno-oncology
 
88,829

 
52,350

 
167,508

 
101,625

 
 
$
222,128

 
$
163,414

 
$
432,495

 
$
383,108


Antibodies
In November 2007, the Company entered into a global, strategic collaboration with Sanofi to discover, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration"). The Antibody Collaboration is governed by the companies' Discovery and Preclinical Development Agreement ("Antibody Discovery Agreement") and a License and Collaboration Agreement (each as amended). Pursuant to the Antibody Discovery Agreement, Sanofi agreed to fund up to $130.0 million of the Company's research activities in 2017. The Company's Antibody Discovery Agreement with Sanofi will end on December 31, 2017 without any extension and, therefore, funding from Sanofi under the Antibody Discovery Agreement will cease after 2017.
Under the License and Collaboration Agreement, agreed-upon worldwide development expenses incurred by both companies are funded by Sanofi, except that following receipt of the first positive Phase 3 trial results for a co-developed drug candidate, subsequent Phase 3 trial-related costs for that drug candidate ("Shared Phase 3 Trial Costs") are shared 80% by Sanofi and 20% by Regeneron. Consequently, during the three months ended June 30, 2017 and 2016, the Company recognized as research and development expense $20.6 million and $30.6 million, respectively, and during the six months ended June 30, 2017 and 2016, the Company recognized as research and development expense $45.6 million and $52.3 million, respectively, of antibody development expenses that the Company was obligated to reimburse to Sanofi related to Praluent®, Kevzara® (sarilumab), and Dupixent® (dupilumab).
"Reimbursement of Regeneron commercialization-related expenses" in the table above represents reimbursement of internal and external costs in connection with preparing to commercialize or commercializing, as applicable, Praluent, Kevzara, and Dupixent. During the same periods that the Company recorded reimbursements from Sanofi related to the Company's commercialization expenses, the Company also recorded its share of losses in connection with the companies preparing to commercialize or commercializing, as applicable, Praluent, Kevzara, and Dupixent within Sanofi collaboration revenue.
In March 2017, the U.S. Food and Drug Administration ("FDA") approved Dupixent for the treatment of adult patients with moderate-to-severe atopic dermatitis. In May 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis and in June 2017, the European Commission granted marketing authorization for Kevzara for the treatment of rheumatoid arthritis in adult patients. Therefore, commencing in 2017, the Company's share of losses in connection with commercialization of antibodies also included the Company's share of revenue in connection with Sanofi's sales of Kevzara and Dupixent.
Immuno-Oncology
In July 2015, the Company and Sanofi entered into a collaboration to discover, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). The IO Collaboration is governed by an Immuno-oncology Discovery and Development Agreement ("IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement ("IO License and Collaboration Agreement"). Pursuant to the IO Discovery Agreement, Sanofi will reimburse the Company for up to $200.0 million in 2017 to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept. Under the terms of the IO License and Collaboration Agreement, the parties are co-developing the Company's antibody product candidate targeting the receptor known as programmed cell death protein 1, or PD-1 ("REGN2810"). The parties share equally, on an ongoing basis, development expenses for REGN2810.
The $640.0 million in aggregate up-front payments made by Sanofi during 2015 in connection with the execution of the IO Collaboration has been recorded by the Company as deferred revenue, and is being recognized ratably as revenue over the related performance period.
b. Bayer
The collaboration revenue the Company earned from Bayer is detailed below:
 
 
Three Months Ended
June 30,
 
Six Months Ended
June 30,
Bayer Collaboration Revenue
 
2017
 
2016
 
2017
 
2016
EYLEA:
 
 
 
 
 
 
 
 
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
 
$
190,883

 
$
167,492

 
$
365,759

 
$
313,327

Reimbursement of Regeneron EYLEA development expenses
 
2,329

 
2,224

 
4,780

 
4,967

Other
 
10,593

 
13,355

 
21,196

 
39,847

Total EYLEA
 
203,805

 
183,071

 
391,735

 
358,141

PDGFR-beta antibody:
 
 
 
 
 
 
 
 
Reimbursement of rinucumab/aflibercept (REGN2176-3) development expenses
 
1,321

 
2,762

 
3,178

 
4,658

Other
 
19

 
2,607

 
32

 
5,233

Total PDGFR-beta antibody
 
1,340

 
5,369

 
3,210

 
9,891

Ang2 antibody:
 
 
 
 
 
 
 
 
Reimbursement of nesvacumab/aflibercept (REGN910-3) development expenses
 
3,070

 
2,074

 
5,111

 
2,074

Other
 
2,140

 
1,382

 
4,238

 
1,382

Total Ang2 antibody
 
5,210

 
3,456

 
9,349

 
3,456

 
 
$
210,355

 
$
191,896

 
$
404,294

 
$
371,488


EYLEA outside the United States
Under the terms of the license and collaboration agreement with Bayer for the global development and commercialization outside the United States of EYLEA, Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA. In Japan, the Company is entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales. In addition, all agreed-upon EYLEA development costs incurred by the Company and Bayer are shared equally.
PDGFR-beta antibody outside the United States
In 2014, the Company entered into a license and collaboration agreement with Bayer governing the joint development and commercialization outside the United States of an antibody product candidate to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta), including REGN2176-3, a combination product candidate comprised of an antibody to PDGFR-beta co-formulated with aflibercept. The agreement provided that the Company would conduct the initial development of the PDGFR-beta antibody through completion of the first proof-of-concept study, upon which Bayer would have a right to opt-in to license and collaborate on further development and commercialization outside the United States. Effective in the first quarter of 2017, the Company discontinued clinical development of REGN2176-3, and on July 31, 2017, the Company and Bayer agreed to terminate the agreement.
Ang2 antibody outside the United States
In March 2016, the Company entered into an agreement with Bayer governing the joint development and commercialization outside the United States of an antibody product candidate to angiopoietin-2 (Ang2), including in combination with aflibercept, for the treatment of ocular diseases or disorders. In connection with the agreement, Bayer made a $50.0 million non-refundable up-front payment to the Company and is obligated to pay 25% of global development costs and 50% of development costs exclusively for the territory outside the United States. The $50.0 million up-front payment was initially recorded as deferred revenue, and is being recognized ratably as revenue over the related performance period.
c. Mitsubishi Tanabe Pharma
In 2015, the Company and Mitsubishi Tanabe Pharma Corporation ("MTPC") entered into a collaboration agreement providing MTPC with development and commercial rights to fasinumab, the Company's nerve growth factor antibody in late-stage clinical development, in certain Asian countries. In connection with the agreement, MTPC made a $10.0 million non-refundable up-front payment. In the first quarter of 2016, MTPC made additional payments of $45.0 million and $15.0 million to the Company, which were recorded as deferred revenue and are being recognized ratably as revenue over the same performance period as the up-front payment.
In the second quarter of 2017, the Company earned, and recognized as a substantive milestone, a $30.0 million development milestone from MTPC upon initiation of a Phase 3 trial.
d. Teva
In September 2016, the Company and Teva entered into a collaboration agreement (the "Teva Collaboration Agreement") to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to the Company's collaboration agreement with MTPC (as described above). In connection with the Teva Collaboration Agreement, Teva made a $250.0 million non-refundable up-front payment in September 2016. The Company leads global development activities, and the parties share development costs equally on an ongoing basis. The $250.0 million up-front payment was initially recorded as deferred revenue, and is being recognized ratably as revenue over the related performance period.
The Company recognized $67.7 million and $100.8 million of revenue for the three and six months ended June 30, 2017, respectively, in connection with the Teva Collaboration Agreement. In the second quarter of 2017, the Company earned, and recognized as a substantive milestone, a $25.0 million development milestone from Teva upon initiation of a Phase 3 trial.
e. Intellia Therapeutics
In April 2016, the Company entered into a license and collaboration agreement with Intellia Therapeutics, Inc. to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development. The Company collaborates with Intellia to conduct research for the discovery, development, and commercialization of new therapies, in addition to the research and technology development of the CRISPR/Cas platform. In connection with the execution of the agreement, the Company made a $75.0 million up-front payment, which was recorded as research and development expense in the second quarter of 2016. In May 2016, Intellia completed an initial public offering ("IPO") of its common stock; as part of the concurrent private placement, the Company purchased $50.0 million of Intellia common stock.