- Biogen kept information on its closely watched Alzheimer's drug BAN2401 well-guarded during a Tuesday earnings call, choosing instead to focus on the durability of its multiple sclerosis portfolio and the growth of its muscular degeneration business.
- The big biotech raised annual revenue and earnings per share guidance after beating analyst expectations on both line items in the second quarter. Revenue totaled $3.36 billion, a 9% increase year over year that was driven by more spinal muscular atrophy (SMA) patients — and particularly those outside the U.S. — starting treatment with Spinraza, as well as the strongest quarterly performance for Tecfidera since Roche's rival therapy Ocrevus came to market.
- Executives also announced Biogen had acquired two drugs, one preclinical and one early-stage, from California-based AliveGen for $27.5 million upfront and $535 million in potential milestone payments. Each drug is a recombinant protein that targets a signaling pathway thought to negatively affect muscle development. Biogen plans to test them in multiple neuromuscular diseases, including SMA and amyotrophic lateral sclerosis.
Biogen's stock reflected its positive second quarter results, spiking 6% to $380 per share at market's open Tuesday. Yet it likely won't stay there for long.
On Wednesday, the biotech and partner Eisai are set to release more data from a Phase 2 study of their drug BAN2401, which binds to proteins called amyloid beta protofibrils that research suggests are part of Alzheimer's disease pathology. While BAN2401 failed to meet the trial's primary endpoint after a year, an analysis at 18-months showed the drug's highest-tested dose was slowing cognitive decline and decreasing amyloid protein plaques.
If positive, the results could be huge for Alzheimer's drug development. The Food and Drug Administration so far hasn't approved any treatments for the underlying causes of the disease, largely because most clinical candidates flunk out before reaching regulators' desks.
The results would also be huge for Biogen. Analysts note there could be a $100 per share difference in the biotech's stock depending on the efficacy BAN2401 shows. Between 30% and 40% of responders to a recent Evercore ISI investor survey thought shares would hit $400 apiece should BAN2401 demonstrate a 25% benefit on a new measurement system, the Alzheimer's Disease Composite Score (ADCOMS), as well as a 20% benefit on the Clinical Dementia Rating scale.
But if the ADCOMS results are 15% or below, shares could drop to near $300 apiece, according to Mizuho's Salim Syed.
Analysts on the Biogen earnings call pushed for more details about the Phase 2 trial, its readout and the next steps the company is planning to take with regard to developing and filing BAN2401. They didn't get many answers.
"Look, our next steps are to talk to FDA and other regulators. We'll see what they say. And I think it's too early to speculate as to whether or not we can file with this," Biogen's Chief Medical Officer Al Sandrock said on the call.
Company leadership was more open about other areas of its pipeline and portfolio. In multiple sclerosis, Tecfidera (dimethyl fumarate) had its highest level of new patient starts in the U.S. in a year, while Tysabri (natalizumab) achieved more stable U.S. volumes and patient growth in European and emerging markets.
And in SMA, Biogen filed Spinraza (nuserinsen) for approval in seven more countries — advancements that strengthen the franchise as rival therapies like Roche and PTC Therapeutics' RG7916 advance through the clinic.
"It's still early days, but we've always said from the beginning that we welcome additional modalities; we think that there's going to be a world in the future where there are multiple options for patients with SMA, whether it's Spinraza, whether potential gene therapy as we're seeing, whether oral splice modulators," the company said.
"And this kind of combinatorial effects or complementary effects to different mechanisms are things we're actively exploring."