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Agreements

Date: 2017-01-12

Type of information: Establishment of a new subsidiary in the US

Compound: spin-off of the hemophilia business (Bioverativ)

Company: Biogen (USA - MA) Bioverativ (USA - CA)

Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases

Type agreement: establishment of a new subsidiary in the US

Action mechanism:

Disease: hemophilia A, hemophilia B

Details:

  • • On May 3, 2016, Biogen announced that it intends to spin off its hemophilia business as an independent, publicly traded company. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise. The new company, to be named at a later date, will focus on the discovery and development of therapies for the treatment of hemophilia, with existing marketed products to include Eloctate® and Alprolix®, indicated for the treatment of hemophilia A and B, respectively.
  • The new company is expected to continue to develop and commercialize Eloctate® and Alprolix® under Biogen's existing collaboration agreement with Swedish Orphan Biovitrum(Sobi). Eloctate® and Alprolix® generated combined revenues of $640 million during the twelve-month period ended March 31, 2016.
  • The new company plans to bring longer acting therapies utilizing the XTEN technology into clinical development in the first half of 2017 and to accelerate the development of bispecific antibodies and hemophilia-related gene therapy programs. The new company also plans to conduct additional studies to confirm early data that suggest Eloctate®’s potential to rapidly induce immune tolerance in hemophilia patients who develop inhibitors. The spin-off is expected to provide investors with greater visibility into the financial and operational structures of each company and a clearer understanding of their respective strategies. Biogen believes creating two stand-alone companies with dedicated and talented management teams will provide the necessary foundation for long-term value creation for each company.
  • John G. Cox, Biogen’s current Executive Vice President, Pharmaceutical Operations & Technology, will serve as the Chief Executive Officer of the new company. Mr. Cox joined Biogen in 2003 and has held several senior executive positions, including Senior Vice President of Technical Operations, Senior Vice President of Global Manufacturing, and Vice President of Manufacturing and General Manager of Biogen’s operations in Research Triangle Park, North Carolina.
  • The new company is expected to be headquartered in the Boston area. The new company will retain commercial rights for Eloctate® and Alprolix® for North America and for rest of the world markets outside of, essentially, Europe, North Africa, Russia and certain countries in the Middle East. Biogen is expected to provide transition services to the new company for some period of time and is expected to remain the manufacturer of Eloctate® and Alprolix® for the next three to five years. The full management team and board of directors of the new company will be named at a later date.
  • Biogen’s board of directors has authorized management to proceed with a plan to spin off its hemophilia business. The spin-off is planned to be completed by the end of 2016 or early 2017, subject to the satisfaction of certain conditions, including, among others, final approval of Biogen’s board of directors, receipt of a favorable opinion with respect to the tax-free nature of the transaction, and the effectiveness of a Form 10 registration statement that will be filed with the SEC. The spin-off is expected to be accomplished through a distribution of shares of the new publicly traded company to Biogen stockholders, in a transaction intended to be tax-free for U.S. federal income tax purposes.
     

Financial terms:

Latest news:

  • • On January 12, 2017, Biogen announced that it has been advised by NASDAQ that the common stock for Bioverativ, the spinoff of its global hemophilia business, begins trading, Thursday, January 12, 2017, on a "when-issued" basis under the symbol "BIVVV" on the NASDAQ Global Select Market. The “when-issued” status of trading of Bioverativ common stock is expected to convert to regular-way trading on Thursday, February 2, 2017, at which time Bioverativ common stock will trade under the symbol “BIVV” on the NASDAQ Global Select Market. The spin-off is expected to be completed on February 1, 2017. Following the spin-off, Bioverativ will be an independent, publicly-held global biotechnology company dedicated to advancing the research, development and commercialization of innovative therapies to address areas of serious unmet need for people with hemophilia and other rare blood disorders.
  • • On December 22, 2016, Biogen announced that the U.S. Securities and Exchange Commission (SEC) has declared effective the Registration Statement on Form 10 filed by Bioverativ Inc. Biogen expects to complete the separation of Bioverativ into an independent, global biotechnology company focused on hemophilia and other rare blood disorders on February 1, 2017. Biogen’s board of directors approved the planned separation of Biogen and Bioverativ on December 20, 2016, and declared a special dividend distribution of one share of Bioverativ common stock for every two shares of Biogen common stock held as of the close of business on January 17, 2017, the record date for the distribution. Shareholders will receive cash in lieu of fractional shares. The special dividend distribution is expected to be paid on February 1, 2017. Biogen expects that starting on January 12, 2017, common stock of Biogen will trade on the NASDAQ Global Select Market in two markets: "regular-way" under the symbol "BIIB" and in the "ex-distribution" market under the symbol "BIIB WI." Shares of Biogen common stock trading under "BIIB" will carry the right to receive shares of Bioverativ common stock, if held as of the close of business on January 17, 2017. Shares of Biogen common stock trading under "BIIB WI" will not carry the right to receive shares of Bioverativ as part of the special dividend distribution. If shares of Biogen common stock are sold in the "regular-way" market after January 17, 2017 but before the distribution date, the shareholder is selling the right to receive shares of Bioverativ common stock with respect to such Biogen shares as part of the distribution. Biogen shareholders are encouraged to consult with their financial advisors regarding the specific consequences of selling Biogen common stock on or before that date.
  • • On August 9, 2016, Biogen announced that Bioverativ will be the name of the standalone, publicly-traded global biotechnology company that it expects to launch in early 2017. Bioverativ will be focused on the discovery, research, development and commercialization of treatments for hemophilia and other blood disorders. Following completion of the spin-off, Bioverativ plans to trade under the symbol BIVV on the NASDAQ Stock Market. Bioverativ will continue commercialization of Eloctate® and Alprolix®, indicated for the treatment of hemophilia A and B, respectively, under Biogen's existing collaboration agreement with Swedish Orphan Biovitrum. After the spin-off, Bioverativ expects to continue development of Eloctate® and Alprolix®, including conducting studies to explore the potential benefits of Fc fusion technology on long-term joint health, immunogenicity and immune tolerance induction in hemophilia patients who develop inhibitors.
  • Bioverativ will also focus on advancing pipeline programs that address areas of unmet need in hemophilia and other blood disorders, including programs studying longer-acting factor therapies that utilize XTEN technology, a non-factor bi-specific antibody program to treat patients with hemophilia A and patients with inhibitors, and gene therapy programs for hemophilia A and B, as well as ongoing research relating to sickle cell disease.
  • Biogen announced its intent to spin-off its hemophilia business in May 2016. The spin-off is planned to be completed in early 2017, subject to the satisfaction of certain conditions, including, among others, final approval of Biogen’s board of directors, receipt of a favorable opinion with respect to the tax-free nature of the transaction, and the effectiveness of a Form 10 registration statement that is filed with the U.S. Securities and Exchange Commission (SEC).

Is general: Yes