Biogen's drug for Alzheimer's disease, once considered a blockbuster-in-waiting, has run into so many obstacles since gaining approval last June that the company is now scrapping its marketing plans almost entirely.
The challenges facing the drug, called Aduhelm, might not have come at a worse time for Biogen. Most of the company's top-selling products are in decline due to fresh competition. Its stock price, at $205 as of Tuesday's close, is down 25% from a year ago. And while there are a few research programs with the potential to become lucrative products — namely, another Alzheimer's therapy known as lecanemab — many analysts still view Biogen's pipeline of experimental brain and nervous system drugs as "high risk."
The company's board has therefore decided it's time for a shakeup. On Tuesday, as part of a quarterly earnings presentation, Biogen announced it is searching for a new CEO to replace Michel Vounatsos, who's led the storied biotech for the last five years. Additionally, executives said that two priorities moving forward will be making deals and "derisking" Biogen's research.
But how exactly Biogen intends to implement this strategy remains unclear.
With dealmaking, for example, the company said it spent about $6.5 billion on business development over the last five and a half years. Yet much of that money has gone to smaller-scale research collaborations or licensing agreements, rather than all-out acquisitions. In fact, since its multibillion-dollar merger with Idec in the early 2000s, Biogen has avoided big-ticket acquisitions altogether, with its largest being the $800 million purchase of Nightstar Therapeutics in 2019.
Biogen has about $6 billion in cash to do more deals, and if it takes on more debt, that number could grow to roughly $8 billion. Still, biotech acquisitions are often expensive. Even though many companies are now valued much lower due to a sector-wide downturn, $8 billion might not be enough to complete what some would judge a transformational deal.
Notably, Biogen executives don't seem to think they'll need that much money. "We've got so much cash on hand right now that adding debt is not something that we would obviously be needing or looking to do in the near term," Chief Financial Officer Mike McDonnell told investors Tuesday.
Analysts at the investment firm Piper Sandler wrote that, given Biogen's "historic reticence" to pursue deals for more advanced, often pricier drugs, "we frankly struggle to see whether this will form a significant part of a successful ... turnaround."
They highlighted, too, how recent deals inked by Biogen haven't amounted to much in terms of promising programs or new products. Multiple assets acquired in the Nightstar buyout, for example, have failed in key clinical trials.
Those setbacks, along with others involving experimental treatments for stroke, ALS, Alzheimer's and Parkinson's disease, have fueled criticism of Biogen's pipeline and calls for the company to diversify beyond its core area of neuroscience.
Though scant on specifics, company executives on Tuesday's call stressed that derisking is part of the strategy. Priya Singhal, interim head of research and development, said neuroscience will remain a focus, but that Biogen is "definitely open to adjacencies." On that front, she noted Biogen's work in neuropsychiatry, where it's co-developing depression therapies with Sage Therapeutics as well as testing a potential medicine for the cognitive impairment associated with schizophrenia.
The company also says it's interested in immunology, as evidenced by a couple of lupus drugs that have advanced to the final stage of human testing. "That's a specialized immunology field, and we may consider other indications, we may consider other potential opportunities in the space," Singhal said. "So that's one way in which we would diversify and rebalance our risk."
Yet, the most closely watched asset in Biogen's pipeline continues to be lecanemab, a drug meant to work in a similar way to Aduhelm.
Biogen and its development partner Eisai have already begun the process of submitting lecanemab to the Food and Drug Administration for approval. Their application, expected to be completed before the end of June, is based on a mid-stage trial that, according to the companies, generated some positive findings, although it ultimately failed on its main objective.
As Biogen and Eisai wrap up their application, they're also sponsoring a larger trial meant to confirm the drug's benefits. That study should produce data by September.
If positive, the study could help Biogen take another shot at bringing an Alzheimer's drug to market. As such, some believe that, in spite all the talk about new priorities, the real focus over the next few months will be on the future of lecanemab.
"Whatever strategic initiatives are to occur, it is hard to imagine much that can be done to sway investors before the lecanemab Phase 3 data readout," wrote Brian Skorney, an analyst at Baird.