Biogen Sees Pivotal Pipeline Moment as It Expands Beyond Neurology

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 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.

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.

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.