Biogen Sees Pivotal Pipeline Moment as It Expands Beyond Neurology

Key Points

• Biogen’s pipeline is reaching a pivotal stage: The company now has 10 Phase III programs, with clinical readouts beginning in the fourth quarter, as it seeks to offset declines in its legacy multiple sclerosis business and return to growth.
• The company is diversifying beyond neurology through investments in immunology and nephrology, including felzartamab for antibody-mediated kidney transplant rejection and potential additional indications. The Apellis acquisition also adds commercial products such as SYFOVRE and infrastructure to support future launches.
• Biogen expects roughly $250 million in annualized cost savings exiting next year, while managing Apellis-related interest costs and planning to pay down acquisition debt by the end of 2027. Management expects to pursue earlier-stage deals in immunology, rare disease and neurology through 2027.

Biogen NASDAQ: BIIB executives said the company is focused on diversifying beyond its historical neurology concentration, advancing a broader late-stage pipeline and managing expenses as it seeks to return to growth.

Speaking at a Wells Fargo conference, Chief Financial Officer Robin Kramer said Biogen has made progress launching growth products, offsetting erosion in its multiple sclerosis portfolio and reshaping its research pipeline. The company now has 10 Phase III programs, with readouts beginning in the fourth quarter, she said.

“The pipeline is at a pivotal point for us from a growth perspective,” Kramer said. She added that Biogen is also working to control operating expenses while investing in product launches and pipeline development.

Portfolio diversification and capital allocation

Kramer said Biogen’s Fit for Growth initiative was designed to optimize the company’s cost base and infrastructure while redirecting investment from its MS portfolio to newer launches, including LEQEMBI, SKYCLARYS and ZURZUVAE. The company also prioritized R&D programs where it had the highest conviction, she said.

Adam Keeney, Biogen’s head of corporate development, said the company has intentionally looked for development opportunities with validated endpoints, clearer regulatory paths and more established Phase III trial designs. That approach differs from pursuing unvalidated biology across the portfolio, he said.

Biogen has expanded into immunology and nephrology through transactions including its acquisition of HI-Bio and its felzartamab asset. Keeney said felzartamab’s initial focus is antibody-mediated rejection, or AMR, in kidney transplantation.

According to Keeney, there are no approved therapies for AMR, and approximately 11,000 U.S. patients experience secondary rejection of their kidney transplants. He described AMR as the “foundational opportunity” for felzartamab, which Biogen also plans to evaluate in IgA nephropathy, membranous nephropathy and other potential indications.

Biogen has also initiated two undisclosed Phase II proof-of-concept studies involving CD38 in autoantibody-driven diseases outside nephrology, Keeney said.

Apellis acquisition and nephrology expansion

The company said its acquisition of Apellis added commercial products and nephrology capabilities, including medical and commercial infrastructure that could support a future felzartamab launch. Kramer said Biogen expects the Apellis transaction to be dilutive in 2026, primarily because of interest expense.

Biogen has already implemented some cost actions, she said, and expects annualized savings of roughly $250 million exiting next year. Those savings are expected to come largely from research and development and general and administrative functions, while sales and medical organizations are being kept largely intact.

Keeney said Biogen sees significant opportunity in geographic atrophy, where Apellis’ SYFOVRE operates. He said the market remains underpenetrated and that growth will depend on bringing in new patients and maintaining persistence among patients already receiving treatment.

“New patient starts and persistency are critical,” Keeney said, adding that Biogen is considering direct-to-consumer and other awareness efforts around the need for early intervention and continued treatment.

MS, SMA and royalty considerations

Kramer said TYSABRI has shown resilience following biosimilar entry, which she attributed to the product’s reputation among neurologists and patients, Biogen’s patient-services organization and its FDA-approved JCV assay. Outside the U.S., the company also offers a subcutaneous formulation of TYSABRI.

She said the company’s growth portfolio more than offset erosion in the legacy MS portfolio for most quarters in 2025. In the second quarter, growth products excluding the two Apellis products exceeded the legacy MS portfolio, according to Kramer.

Biogen also expects continued contributions from its relationship with Roche and Genentech. Kramer noted that Roche recently launched a subcutaneous version of OCREVUS, which has shown traction. Biogen receives royalties tied to OCREVUS and participates in profit-sharing arrangements involving RITUXAN and GAZYVA. GAZYVA received U.S. and European approvals for lupus nephritis this year, she said.

In spinal muscular atrophy, executives said SPINRAZA patient volumes have stabilized and that patients have transitioned rapidly from lower-dose treatment to the higher-dose option. Biogen also sees its acquired Alcyone device technology as a way to reduce administration barriers for certain patients receiving intrathecal therapies. The implanted device could allow SPINRAZA to be injected through a port rather than requiring a spinal tap for each quarterly administration, Keeney said.

Outlook for business development

Looking ahead, Keeney said Biogen expects to focus more on earlier-stage business-development opportunities through 2027, particularly in immunology, rare disease and neurology. He said the company is not financially constrained for early-stage transactions and could consider larger transactions as its balance sheet builds next year.

Kramer said Biogen expects to pay down debt associated with the Apellis deal by the end of 2027. For the coming year, she said success would mean meeting growth portfolio commitments on revenue and earnings while preparing for potential launches in lupus and AMR.

About Biogen (NASDAQ:BIIB)

Biogen Inc is a biotechnology company focused on discovering, developing and commercializing therapies for neurological and neurodegenerative diseases. Founded in 1978, the company is headquartered in Cambridge, Massachusetts, and serves patients and healthcare providers in markets around the world.

Biogen's portfolio includes treatments for multiple sclerosis, including Tecfidera, Vumerity, Tysabri, Avonex and Plegridy, as well as Spinraza for spinal muscular atrophy, developed in collaboration with Ionis Pharmaceuticals.

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