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Dec 31, 2022
Biogen Q4 2022 Earnings Report
Biogen's Q4 2022 results were released, exceeding full year 2022 revenue and Non-GAAP EPS guidance, and full year 2023 guidance was provided.
Key Takeaways
Biogen reported Q4 2022 revenue of $2,544 million, with a GAAP diluted EPS of $3.79 and a Non-GAAP diluted EPS of $4.05. The company is strategically focused on growth drivers such as LEQEMBI in Alzheimer’s disease and zuranolone in depression, while also working to diversify its product portfolio and improve R&D productivity.
LEQEMBI (lecanemab-irmb) received FDA Accelerated Approval and is under regulatory review in the E.U. and Japan.
Phase 2 clinical trials have begun for a potential first-in-class therapy targeting tau.
The New Drug Application for zuranolone, a treatment for MDD and PPD, has been accepted in the U.S. with Priority Review.
Biogen is prioritizing programs with attractive risk-reward profiles and diversifying into specialized immunology, neuropsychiatry, and rare diseases.
Biogen
Biogen
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Biogen anticipates a mid-single-digit revenue decline for 2023 compared to 2022, with Non-GAAP EPS expected to be between $15.00 and $16.00. This guidance relies on a favorable legal decision regarding TECFIDERA and includes modest in-market revenue for LEQEMBI, with commercialization expenses exceeding revenue.
Positive Outlook
- Expects mid-single digit revenue decline versus 2022
- Non-GAAP EPS of $15.00 to $16.00
- Assumes a favorable decision by the Court of Justice of the European Union relating to regulatory data protection for TECFIDERA, which is currently expected on March 16, 2023
- Expects modest in-market revenue for LEQEMBI in 2023
- Assumes that foreign exchange rates as of December 31, 2022, will remain in effect for the remainder of the year, net of hedging activities.
Challenges Ahead
- Biogen expects modest in-market revenue for LEQEMBI in 2023 with commercialization expenses exceeding revenue.
- Biogen will record its share of net commercial profits and losses for LEQEMBI in the U.S. as a component of total revenue, which is expected to be a headwind to revenue in 2023.
- This financial guidance does not include any impact from potential acquisitions or large business development transactions or pending and future litigation, as all are hard to predict, or any impact of potential tax or healthcare reform.
- Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2023 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.
- Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from our equity security investments; and the ultimate outcome of pending significant litigation without unreasonable effort.
Revenue & Expenses
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