Biogen Inc. Q1 FY2026 earnings call

• Strong start to 2026, stabilized business after 4 years of declining revenue and profit. - Shifted costs, 90% of commercial costs behind MS portfolio in 2023 shifted to growth products. - High dose SPINRAZA approved in U.S., Japan, Europe, with positive feedback and anecdotal reports of switch backs. - LEQEMBI has significant patients continuing on after 18 months regimen, PDUFA date for induction subcutaneous May 24. - Proposed acquisition of Apellis expands commercial growth portfolio, expected to be accretive in 2027 and increase EPS outlook. - Pipeline progress: Salanersen has durable benefit over 1 year in children, first patient dosed in STELLA-1 study; Litifilimab positive Phase II data in SLE; felzartamab first patient dosed in STELLAR 1; high conviction pipeline with multiyear registrational data flow starting this year.

Growth products generated $851 million in the first quarter, up 12% year-over-year. LEQEMBI market revenue was $168 million, up 74% year-over-year. SKYCLARYS had global revenue of $151 million, 22% growth year-over-year. Non-GAAP R&D expense in Q1 2026 was $480 million, non-GAAP SG&A expense was $600 million. Growth products include VUMERITY, which generated more revenue in Q1 2026 than remaining MS products. LEQEMBI is market leader in U.S., Japan, China. SKYCLARYS available in 35 countries with growth expected from ex U.S.

• Overall belief in strength of underlying business remains strong as when guided in February. - Expect roughly $600 million of contract manufacturing revenue this year, 2/3 in first half. - Q2 core operating expenses expected roughly consistent with Q1. - Incur $145 million or $0.80 EPS impact of acquired IPR&D charges in Q2, including $0.55 from TJ Bio transaction for felzartamab rights in China and $0.25 from STELLAR 1 milestone. - Transaction with Apellis not yet closed, will provide 2026 guidance inclusive of Apellis when results reported after close. Believe Apellis will contribute best-in-class commercialized medicines to growth portfolio, expect $120 - $130 million impact to non-GAAP and other income expense line in 2026, expect to delever by end of 2027, transaction accretive to non-GAAP EPS in 2027.

Q: On BIIB080, views on data and dosing regimen?

A: Priya Singhal says BIIB080 is antisense oligonucleotide, Phase Ib showed tau reduction, expecting data midyear, looking at totality of data including dosing regimens.

Q: On LITIFILIMAB filing strategy?

A: Priya Singhal says excited about potential, 2 Phase III trials in SLE expected to read out this year, filing strategy to be package, will communicate more as studies read out.

Q: On BIIB080 study design and go/no-go?

A: Priya Singhal says trial redesigned based on Phase Ib readout, confident trial set up to test hypothesis, will be disciplined in looking at data midyear.

Q: On LEQEMBI blood-based biomarkers and patient switch?

A: Alisha Alaimo says blood-based biomarkers adoption growing, CMS added use for confirmation, Q1 sees patients completing 18-month mark, physicians looking at switching to LEQEMBI.

Q: On SYFOVRE competitive dynamics?

A: Priya Singhal says SYFOVRE has compelling data on lesion growth, 42% reduction, 5-year data creates moat, competitive landscape evolving but SYFOVRE has advantage.

Q: On SYFOVRE franchise spending and prefilled syringe?

A: Alisha Alaimo says impressed with Apellis team, GA market promotionally sensitive, prefilled syringe optimism but no specific details on meaningfulness.

Q: On high dose SPINRAZA impact?

A: Alisha Alaimo says 20% of patient base have start forms for high dose, seeing interest from patients and physicians, Robin Kramer says ex U.S. seeing similar traction.

Q: On SKYCLARYS drivers?

A: Alisha Alaimo says Q1 SKYCLARYS revenue affected by inventory and fewer buying weeks, patient demand on par, Robin Kramer says ex U.S. revenue exceeded U.S. in quarter.

Q: On BIIB080 other tauopathies and biomarker?

A: Priya Singhal says discussing potential in other primary tauopathies, looking for tau reduction and other details in Phase II results.

Q: On FELS for AMR and China rights?

A: Christopher Viehbacher and Priya Singhal discuss kidney disease market, AMR patient numbers, competitiveness of felzartamab targeting CD38 and durability.

Q: On LEQEMBI real-world persistence and subcu version?

A: Priya Singhal says real-world data shows patients want to continue on LEQEMBI, subcu initiation PDUFA next month, optimistic about inflection in patient journey