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BiogenInc. BIIB shares have risen 40.7% this year so far compared with the industry’s increase of 2.7% in the same time frame.
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The share price increase was driven mainly by FDA approval of Biogen’s Alzheimer’s disease drug, Aduhelm (aducanumab), on an accelerated basis, in June. The label states that Aduhelm treatment should be initiated for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
Aduhelm has become the first medicine to be approved to reduce the clinical decline associated with this devastating disease and targeting the underlying cause of the disease. Aduhelm should bring in huge revenues for Biogen, if the drug is successfully commercialized given strong demand. Aducanumab is also under review in the EU, Japan and some other countries.
Biogen regularly in-licenses assets to build its pipeline with several candidates having transformative potential. It boasts a robust late-stage pipeline with several important data readouts expected in the second half.
Among some recent deals, Biogen signed a collaboration with Sangamo Therapeutics SGMO in 2020 to make gene regulation therapies for a range of neurological indications including Alzheimer's disease. It also collaborated with Denali Therapeutics DNLI in August 2020 to co-develop and co-commercialize its small molecule LRRK2 inhibitor program, DNL151/ BIIB122, for Parkinson’s disease, which will enter late-stage development in 2021. In November 2020, Biogen signed a collaboration with Sage Therapeutics SAGE, which added a late-stage program (zuranolone) in depression and movement disorders. All these deals signed in 2020 have strengthened its late-stage pipeline.
Biogen’s biosimilar medicines have become important contributors to the top line. Samsung Bioepis, the joint venture between Biogen and Samsung BioLogics, markets three anti-TNF biosimilars in the EU — Flixabi (a biosimilar referencing Remicade), Benepali (a biosimilar referencing Enbrel) and Imraldi (a biosimilar referencing Humira). Biosimilars revenues rose 8% in 2020. Biogen is optimistic that its biosimilars business has the opportunity to potentially double over the next couple of years.
Biogen faces its share of troubles. Aduhelm’s FDA approval faced a lot of criticism regarding its mixed efficacy results, the FDA’s selection of the accelerated approval path, and the regulatory process in general. Aduhelm also comes with a hefty price tag of $56,000 a year, which was widely condemned. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval in November last year due to mixed outcomes data from the ENGAGE and EMERGE phase III studies. All these issues may affect demand, patient access and reimbursement for Aduhelm, which could result in a slow launch.
Multiple generic versions of blockbuster multiple sclerosis drug, Tecfidera have been launched, which are significantly eroding the drug’s sales. Also, sales of its key spinal muscular atrophy (SMA) drug Spinraza are being hurt due to COVID-19. The drug’s competitive environment is also getting challenging.
Nonetheless, sales uptake of Aduhelm, higher biosimilar revenues, regular licensing deals, and positive pipeline developments are expected to keep the stock afloat in the rest of 2021 and 2022.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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