On May 3, 2016, Biogen Inc. (NASDAQ: BIIB) announced that it intends to spin off its hemophilia business as an independent, publicly traded company, to be named Bioverativ Inc. Biogen shareholders will receive one share of Bioverativ for every two shares of Biogen common stock held as of the record date of January 17, 2017. The distribution is expected to be paid on February 1, 2017. Bioverativ has applied for listing of its common stock on the NASDAQ Global Select Market under the ticker symbol “BIVV”.
Founded in 1978, Biogen is one of the world’s oldest biotechnology companies and provides innovative therapies for neurological, autoimmune, and rare diseases, including multiple sclerosis (MS) and hemophilia. The consolidated company generated revenue of $10.8 billion for the year ended December 31, 2015. In late 2015, the company announced a corporate restructuring, which included the termination of a number of pipeline programs (primarily in immunology and fibrosis) and an 11% reduction in workforce. These changes are expected to reduce the current annual run-rate for operating expenses by approximately $250 million.
The spin entity, Bioverativ, will focus on the discovery and development of therapies for the treatment of hemophilia. Currently marketed products are ELOCTATE and ALPROLIX, indicated for the treatment of hemophilia A and B, respectively. Bioverativ generated revenue of $560.3 million in 2015. The spin entity is expected to continue to develop and commercialize ELOCTATE and ALPROLIX under Biogen’s existing collaboration agreement with Swedish Orphan Biovitrum AB (SOBI SS) (Sobi). In addition, Bioverativ plans to pursue programs with other third parties in hemophilia to bring longer-acting therapies utilizing XTEN technology (a proprietary recombinant polypeptide technology licensed from privately-held pharmaceutical company Amunix Operating Inc.) into clinical development in the first half of 2017 and to accelerate the development of bispecific antibodies and hemophilia-related gene therapy programs. Bioverativ will also conduct additional studies to confirm early data that suggest ELOCTATE’s potential to rapidly induce immune tolerance in hemophilia patients who develop inhibitors. John G. Cox, Biogen’s current Executive Vice President, Pharmaceutical Operations & Technology, will serve as the Chief Executive Officer of the new company. The spin entity is expected to be capitalized with a positive cash position and minimal debt.
Biogen has achieved strong profitability on the success of three marketed products in the fields of oncology and neuroimmunology; the company’s market-leading multiple sclerosis franchise, centered around its blockbuster drug Tecfidera, the most prescribed oral MS therapy globally, is unparalleled. Yet, revenue growth is faltering. In 2015, revenue growth declined to 10.9% from 40.0% in 2014; current consensus estimates call for 7% and 4% growth in 2016 and 2017, respectively. Notably, Tecfidera reached a peak in its U.S. business in early 2015, with analysts projecting 2017 sales of $4.19 billion, down from previous estimates of $9 billion. International sales of Tecfidera have been somewhat disappointing (owing to pricing pressure in Europe and several reported cases of a rare brain infection, progressive multifocal leukoencephalopathy [PML]), as has Tecfidera’s direct-to-consumer marketing effort in the U.S. For active, relapsing MS, Biogen’s beta interferon franchise is facing competition from oral agents and from exclusion of coverage for generic Copaxone by CVS Health Corp. (NYSE: CVS), as pharmacy health care providers gravitate toward lower-priced treatments. More recently, the company has focused on key long-term pipeline assets in Alzheimer’s disease, autoimmune, and rare diseases. While these offer significant potential, they are also high risk or have strong competition. Contribution to sales is not expected until beyond 2018. As a result of these factors, the company is under pressure to find new avenues for growth while operating with financial discipline.
The spin-off represents a first step in a longer-term growth strategy. Given that the neurology and hemophilia franchises target different physician and patient segments, the separation allows each post-spin company to pursue different strategic initiatives specific to its core commercial therapies and assets, while leveraging distinct capital allocation strategies. For investors, the separation should provide greater visibility into the financial and operational structures of each company and a clearer understanding of their respective strategies.
The separation allows post-spin Biogen to focus on its neurological and neurodegeneration business, and potentially seek acquisitions to bolster revenue. Outside of MS, Biogen has strong human genetic target validation for its neurology pipeline, creating the potential to offset pressure on MS drugs. Spinal muscular atrophy drug nusinersen could reach $2 billion in peak sales and launch in 2017, following strong phase III clinical data. Alzheimer’s drug aducanumab had strong phase I data that could allow for multibillion-dollar potential if approved (estimated 2020).
For Bioverativ, the company appears to have considerable long-term potential in its hemophilia franchise, which comprises ALPROLIX and ELOCTATE as well as several investigational drugs with favorable prospects.
Based on an analysis of comparable revenue, projected 2017 EPS, and cash flow, a pre-spin sum-of-the-parts estimate of $316 for pre-spin Biogen can be derived, consisting of $289 for BIIB and $28 for BIVV. Post-spin, assuming approximately 110 million shares outstanding (1:2 distribution ratio) Bioverativ can be fairly valued at $55 per share. The pre-spin sum-of-the-parts estimate represents 7% potential upside to BIIB’s current share price (approximately $294 as of this writing), suggesting that the shares are approaching a full valuation. Notably, at 13.9x forward earnings, BIIB’s current valuation represents a slight premium to its 10-year historical average of 12.9x (range of 6.5x to 18.8x).