Biogen NASDAQ: BIIB CEO Christopher Viehbacher told investors at TD Cowen’s 46th Annual Healthcare Conference that the company is focused on building what he described as “a whole new era of growth” through a broadened pipeline, launch execution, and continued financial discipline. Viehbacher said Biogen now has 10 Phase 3 programs, with the first readouts expected this year and additional “cards” turning over sequentially each year through the end of the decade.
Pipeline expansion alongside lower R&D spending
Viehbacher said the company has “dramatically expanded the pipeline” while spending “25% less on R&D” than it did three years ago, citing improved productivity and reallocation of resources toward pre-launch and medical affairs activities. He said Biogen is “very happy” with its late-stage pipeline and is now shifting more attention to “reloading the early-stage pipeline,” including preclinical and early clinical programs.
Two operating stories: growth products versus legacy erosion
Addressing investor focus on when total revenue could return to growth—after Biogen’s guidance for a mid-single-digit revenue decline in 2026—Viehbacher framed the company as “two Biogens.” He said a “new Biogen” is already growing, driven by products launched in the last three years: Leqembi, QALSODY, ZURZUVAE, and SKYCLARYS. He added that Biogen is also “still heavily investing” in SPINRAZA and VUMERITY.
Against that, he described a legacy portfolio facing “ever-increasing competition,” particularly within multiple sclerosis, though he said Biogen has managed the decline “pretty substantially.” Looking ahead, he said growth could be “accentuated” by additional potential launches and catalysts, mentioning felzartamab (including in lupus), salanersen as a potential successor to SPINRAZA, and zorevunersen in Dravet syndrome. He also pointed to potential for “increased sales escalation” for Leqembi coming out of the end of this year and into next year.
Business development: emphasis on fit and nearer-term impact
Viehbacher said Biogen has been active in business development but must be selective given the company’s scale. He argued that replacing $1 billion of after-tax profit could require “about $15 billion–$20 billion,” which he characterized as more than Biogen can do, driving a need for caution on large M&A. He said M&A should not be “the only plank” of strategy and that the company first worked to clarify its therapeutic focus, expanding beyond a purely neuroscience-driven profile that he described as risky and capital intensive.
Looking forward, Viehbacher said the company is interested in assets that fit Biogen’s narrative and can add to cash flow, with less interest in programs that would not launch until 2028 or 2029 because Biogen already has many later-stage opportunities. He said the company would look for assets “early stage in its launch trajectory,” likely with Phase 3 results or “extremely high conviction” in Phase 3.
Leqembi launch: complexity, care pathways, and subcutaneous transition
Viehbacher called Leqembi “by far the most complex launch” of his career, pointing to the operational changes required for neurologists, including infusion capacity, repeat MRIs, diagnostics, patient registration, and reimbursement logistics. He said reimbursement has “almost never been a problem,” including for PET scans, MRIs, and diagnostics, which he suggested helped build physician confidence.
He said physicians have grown more comfortable managing ARIA, noting that most ARIA is asymptomatic and that monitoring has become more routine. He also said physician perception of efficacy has evolved, as clinicians see patient-level functional benefits beyond commonly cited trial measures.
Viehbacher emphasized steps aimed at simplifying diagnosis and treatment logistics:
- Blood-based diagnostics: He said the first blood-based diagnostics have been approved and are enabling triage earlier in the pathway, particularly in primary care. He stated that “several hundred thousand tests” were sold last year by large labs and that the yield of patients appropriate for treatment has improved from about 50% to about 70%.
- Infusion burden and subcutaneous options: He described a shift to monthly infusion for maintenance after the initial amyloid-removal period and said a subcutaneous maintenance form was approved last year. He said the subcutaneous induction regimen is under priority review, with an expected decision date of May 24.
- Direct-to-consumer education: He said Biogen has started patient education through direct-to-consumer advertising after observing that some physicians were treating only one patient—often because a patient requested therapy—prompting a strategy to deepen prescriber engagement and increase patient-driven demand.
On reimbursement dynamics for the subcutaneous form, Viehbacher said IV infusion is covered under Medicare Part B, while the subcutaneous option would be covered under Part D as a separate BLA. He outlined a timing pathway where Part D formulary decisions occur in midyear with coverage effective the following January, and said Biogen would expect coverage decisions in 2026 that could take effect January 1, 2027. He added that formulary exceptions are possible and said the company was not aware of patients being denied exemptions for maintenance, while acknowledging the paperwork burden.
Alzheimer’s pipeline: prevention study timeline and tau program readout
Viehbacher highlighted the AHEAD 3-45 study as a “landmark” effort focused on treating patients earlier in the disease process, including individuals before amyloid levels reach a threshold he associated with increased tau production. He said the study began in 2020 and is expected to read out in 2028. He characterized the long duration as necessary given the uncertainty in how quickly asymptomatic patients progress to symptoms, arguing that an interim analysis could risk misleading results.
He also discussed BIIB080, a tau-targeting program with data expected midyear. Viehbacher said tau is viewed by many neurologists as a highly compelling target because disease severity is believed to correlate with tau levels. He referenced prior Phase 1B data showing significant tau reduction and said the upcoming readout will help answer how tau reduction translates to cognitive outcomes.
SPINRAZA and salanersen: efficacy positioning and administration frequency
Viehbacher discussed SPINRAZA’s positioning in spinal muscular atrophy (SMA), saying that while dosing via intrathecal injection is burdensome, patients and caregivers prioritize efficacy in severe disease. He said Biogen is pursuing a higher-dose SPINRAZA approach, describing a move from 12 mg to 50 mg intended to reach therapeutic levels faster. He noted an April 3 PDUFA date for high-dose SPINRAZA and said early experience in Japan has shown “switchbacks” from oral therapy and some new patients from other treatments.
On pricing, he said Biogen is looking “more at market share as a lever for growth than for pricing.”
For salanersen, Viehbacher said the program was initially aimed at addressing “intrathecal fatigue” with a goal of once-yearly dosing, but he also described Phase 2 observations suggesting potential functional improvements in children previously treated with gene therapy. He cautioned that the findings involve small numbers and need validation in Phase 3.
SKYCLARYS rollout: global patient finding and pediatric expansion
Viehbacher said SKYCLARYS is being rolled out worldwide for a rare disease population that he estimated at fewer than 10,000 globally. He said Biogen recently received approval in Brazil and is seeking reimbursement there, which he described as a potentially significant market. He also said Biogen has “more patients outside the U.S. than inside the U.S.”
In the U.S., he said Biogen has found more older patients than initially expected and is working to convince older patients of the benefits of therapy. He said the company is also pursuing a pediatric indication, as the current label is for patients 16 and older, and estimated the pediatric trial could be completed by 2028. He described reimbursement work as country-by-country and said the company has used early access programs while negotiating pricing.
Multiple sclerosis: managing decline and leveraging patient services
Viehbacher said Biogen expects a mid-teens decline in the MS franchise this year excluding Vumerity, attributing pressure largely to portfolio maturity and competition, including European erosion of TECFIDERA. He said AVONEX and PLEGRIDY are declining at an 8%–10% rate and still generate close to $1 billion in sales globally, which he attributed partly to physician “stickiness” when patients are stable.
On TYSABRI, he described it as a favored therapy among neurologists for efficacy but noted the need for ongoing JC virus assay monitoring due to PML risk. He said biosimilar entrants do not have the same assay, which he suggested could slow physician adoption. He also noted that in Europe, Biogen’s subcutaneous version has helped retain about half of the business, which he described as “sticky.”
Viehbacher said Biogen has redirected substantial promotional resources away from legacy MS products to fund newer launches. He also highlighted Biogen’s in-house patient services organization as a differentiator, describing support for insurance navigation, co-pay assistance, and care pathway education as increasingly important as prior authorization and related delays become more common.
About Biogen NASDAQ: BIIB
Biogen Inc is a multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases. Headquartered in Cambridge, Massachusetts, the company has a longstanding emphasis on neuroscience, with research and commercial activities spanning multiple therapeutic areas including multiple sclerosis, spinal muscular atrophy and Alzheimer's disease. Biogen was founded in 1978 and has grown into a global biopharmaceutical firm with operations and commercial presence across North America, Europe, Japan and other international markets.
The company's marketed portfolio has historically included several well-known therapies for multiple sclerosis such as Avonex, Tysabri and Tecfidera, and it has pursued treatments for rare neurological conditions and genetic neuromuscular disorders.
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