On Tuesday the company announced it was shutting down its sales structure and most of its efforts around Aduhelm in the US, as well as announcing a total of $1bn in cost-reduction measures and the search for a new CEO.
As it looks to the future, Biogen sets out five near-term operational priorities which aim to drive renewed revenue growth and value creation.
1. Prioritizing promising R&D
Firstly, Biogen will look closely at how it prioritizes R&D programs, with the aim of maximizing programs with the best chance of success.
“This may include choosing to accelerate, terminate, divest, or partner certain programs, and will also include a continued evaluation of new internal and external opportunities within Biogen’s therapeutic areas of focus and adjacencies,” says the company.
This will be largely informed by three key data readouts expected in 2022.
The most high-profile will be with lecanemab: another Alzheimer’s monoclonal antibody with a Phase 3 readout expected in the fall this year. Biogen and partner Eisai plan to complete the rolling submission for lecanemab with the FDA in Q2 this year with an application for full FDA approval planned for Q1 2023: which, if successful, would make it the first anti-amyloid antibody to obtain full approval for Alzheimer’s in the US.
While Biogen has substantially cut back on efforts around Aduhelm, it notes that the upcoming data readouts from this class of antibodies could inform subsequent decisions in this area. A Phase 4 trial for the drug, as required by the FDA as part of its approval, is still going ahead with patient screening set to start this month.
In neuropsychiatry, Biogen is working with Sage Therapeutics to advance zuranolone as a new potential treatment option for patients suffering from major depressive disorder (MDD) and post-partum depression (PPD). A readout of the Phase 3 Skylark study in PPD is expected in mid-2022. The companies have initiated the rolling submission of a New Drug Application to the US FDA for MDD, which is expected to be completed in the second half of 2022; with a filing for PDD expected to follow in early 2023.
A third readout is awaited in mid-2022: for the Phase 2 study of BIIB104 in cognitive impairment associated with schizophrenia.
2. Cost reductions
Biogen says it will add an additional $500m in cost reductions through the ‘substantial elimination’ of its global commercial infrastructure for Aduhelm and other cost reductions. This is on top of the $500m in savings previously announced, which include layoffs.
“This brings total expected annualized savings to approximately $1bn, a portion of which will be reinvested in strategic initiatives over the coming years,” says the company.
Biogen outlines its ambitions to renew its focus on biosimilars in the future, with several products in the pipeline.
“While Biogen’s current commercial portfolio of anti-TNF products is likely past the peak of its lifecycle, the company currently has four more programs in development and is preparing to launch Byooviz, referencing Lucentis, in the US in the coming months,” it says.
In April, Biogen completed the sale of the company’s equity stake in the Samsung Bioepis biosimilars joint venture to Samsung Biologics for up to $2.3bn. Together Biogen and Samsung Bioepis will continue with their exclusive agreements, including the commercialization of their current biosimilars portfolio including Benepali, Flixabi, Imraldi in Europe; and the potential upcoming launches of Byooviz and potential filings for SB15 in major markets worldwide.
4. Worldwide growth
Biogen spots an opportunity to execute on international growth opportunities with a focus on key emerging markets, such as China and certain markets in both Latin America and the Middle East.
“This includes the continued launch of Spinraza and may also include pursuing local business development opportunities,” says the company.
5. Revenue growth opportunities
Finally, Biogen says it will continue to focus the deployment of cash on hand and future cash flow towards initiatives designed to create incremental revenue growth opportunities, while continuing to return cash to shareholders through share repurchases.