Q3 2023 Earnings Summary
Reported on Jan 4, 2025 (Before Market Open)
Pre-Earnings Price$245.61Last close (Nov 7, 2023)
Post-Earnings Price$245.69Open (Nov 8, 2023)
Price Change
$0.08(+0.03%)
- Biogen expects significant value from SKYCLARYS following the acquisition of Reata Pharmaceuticals, with plans for expansion into the EU and Latin America, and is accelerating efforts to file for approval in these regions. Additionally, they are in discussions with regulators for a pediatric study, which is important to broaden the patient base.
- Biogen and Eisai are preparing to file data for LEQEMBI maintenance dosing with intravenous infusion every four weeks by Q1 2024, potentially enhancing treatment options for Alzheimer's disease patients.
- Biogen remains confident in securing a positive CHMP opinion for SKYCLARYS from the EMA in early 2024, with regulatory interactions ongoing and expectations remaining on track for approval.
- Uncertainty surrounding EMA approval of SKYCLARYS in the EU market, which represents about one-third of the value of the Reata acquisition, could impact Biogen's expected revenue growth. The company expects an outcome in early 2024 but could not comment on whether there will be an oral explanation, indicating potential regulatory hurdles.
- Lack of clarity on the regulatory path and potential approval for LEQEMBI maintenance dosing, which could affect the drug's long-term market potential. Biogen is preparing data for a potential filing by Q1 2024 but cannot comment on the indication or regulatory outcome, creating uncertainty about future approvals.
- Delays in converting patient interest into actual prescriptions for SKYCLARYS suggest challenges in reimbursement and access, potentially limiting revenue growth. Of 1,180 start forms submitted, only 860 patients are actually on the drug, indicating bottlenecks that the company needs to address.