What is the financial impact of the amended agreement with Sanofi?

Regeneron received $462 million from Sanofi as part of the Amended and Restated Immuno-oncology Discovery and Development Agreement. This payment covers the termination of the original agreement, prepays for certain development activities, and reimburses costs incurred in Q4 2018.

How has the scope of the immuno-oncology collaboration changed?

The collaboration has been narrowed to focus exclusively on the development of bi-specific antibodies targeting BCMA and CD3 (BCMAxCD3 Program) and MUC16 and CD3 (MUC16xCD3 Program) through clinical proof of concept. Other immuno-oncology programs are no longer part of this specific Sanofi collaboration but Regeneron retains rights, subject to Sanofi royalties on REGN3767 and REGN4659.

What are Regeneron's responsibilities and potential upside under the new agreement?

Regeneron is primarily responsible for conducting the discovery and development activities for the BCMAxCD3 and MUC16xCD3 programs up to clinical proof of concept, subject to specified cost caps. Regeneron retains exclusive rights to develop and commercialize any product candidates if Sanofi does not exercise its licensing option, and will receive royalties on sales in such cases. If Sanofi exercises its option, Regeneron will share in future profits and potentially reimburse half of clinical development costs from its share of profits.

What were the preliminary EYLEA® sales for 2018?

Regeneron announced preliminary, unaudited U.S. net product sales for EYLEA® of approximately $4.07 billion for the full year 2018, with approximately $1.07 billion in sales for the fourth quarter of 2018.

REGN 8-K: Earnings & Results, Material Agreements & More

Summary

Regeneron Pharmaceuticals, Inc. (REGN) filed an 8-K on January 7, 2019, detailing a significant amendment to its Immuno-oncology Discovery and Development Agreement with Sanofi, effective December 31, 2018. The amendment narrows the scope of the collaboration to focus on developing two specific bi-specific antibody programs: BCMAxCD3 and MUC16xCD3. Sanofi is providing $462 million to Regeneron as consideration for this updated agreement, covering termination fees, prepayment for development activities, and reimbursement of past costs. Regeneron will primarily lead the research and development through clinical proof of concept, subject to cost caps per program, with Sanofi having options to license the resulting product candidates. The company also provided preliminary 2018 U.S. net product sales for EYLEA® of approximately $4.07 billion, with Q4 2018 sales around $1.07 billion. Investor presentations discussing the corporate update and financial overview for 2019 were also furnished.

Key Highlights

1Amended and restated Immuno-oncology Discovery and Development Agreement with Sanofi, effective December 31, 2018.
2Collaboration scope narrowed to two specific bi-specific antibody programs: BCMAxCD3 and MUC16xCD3.
3Sanofi to pay Regeneron $462 million for agreement termination, development prepayment, and cost reimbursement.
4Regeneron will lead development through clinical proof of concept for the specified programs, subject to cost caps.
5Sanofi has options to license the developed product candidates, with specific commercialization leads outlined.
6Regeneron retains rights to other immuno-oncology programs, with Sanofi receiving royalties on REGN3767 and REGN4659.
7Preliminary full-year 2018 U.S. net product sales for EYLEA® are approximately $4.07 billion.

REGENERON PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jan 7, 2019)

Summary

Key Highlights

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