Quantcast
Channel: Endpoints News
Viewing all articles
Browse latest Browse all 2046

Biogen details Leqembi and Skyclarys rollouts, eyes licensing deals and sells PRV

$
0
0

Biogen’s leaders defended their Eisai-partnered Leqembi during a first-quarter earnings update on Wednesday, saying the Alzheimer’s treatment is on a path to greater uptake as more patients started treatment last month.

The company is in the midst of resetting its business, making hundreds of cuts to its workforce in recent quarters and reshaping its pipeline last year. Now, Biogen said it’s on more solid footing for the future.

An increase in patients on Leqembi and better-than-anticipated sales of its rare disease drug Skyclarys buoyed Biogen’s stock, which was up about 5% $BIIB on Wednesday morning.

Cantor Fitzgerald analysts described Leqembi’s utilization as “modest in scale” but moving “in the right direction.”

“Biogen has taken a more hands-on role in US promotion,” Cantor’s Eric Schmidt wrote. “These efforts appear to be having an impact on broadening and deepening adoption at individual treatment centers.”

Below are key takeaways from Biogen’s first-quarter update, including the disclosure that it sold one of its priority review vouchers for $103 million:

  • Leqembi’s launch has been ‘extraordinarily difficult’: CEO Chris Viehbacher told investors that the rollout of the drug has been challenging. “I’ve been in this business for 3.5 decades,” he said. “I’ve lost count of how many launches I’ve seen. But this is an extraordinarily difficult launch, really because the amount of change that physicians are facing with this is really profound.” He said that it took one hospital “three months to get approval just to hire a nurse to help navigate the system.” And at a “major medical center, they were having to develop a five-year business plan just to be able to access the infusion beds.”
  • Skyclarys rollout: In the US, 1,100 patients are taking the rare disease drug, representing about 24% of the population stateside, according to Alisha Alaimo, Biogen’s head of North America. In Europe, where Skyclarys was approved in January, about 300 people are on treatment. It’s been submitted for approval in Brazil, Viehbacher said. The drug came to Biogen via its $7 billion acquisition of Reata last year.
  • Expect more licensing deals and less M&A: The drugmaker expects to “bring in some new assets both into early-stage research and development” this year, Viehbacher said, by way of licensing deals. After its Reata deal last year, Biogen isn’t looking to splurge on major acquisitions, echoing comments made by Viehbacher last fall. “I don’t think, where we sit right now, we’d be thinking about doing anything this year on an acquisition front,” he told analysts.
  • Along with cuts, a focus on reinvestment: Viehbacher reminded analysts that the company’s “fit-for-growth” plan, which includes reducing 1,000 positions, doesn’t mean cost-cutting across the board. “One of the things that you may not see is that there’s an awful lot of reinvestment going on,” he said. “One of my early bosses in my career once told me you can’t save your way to prosperity in this business, and that is absolutely true.”
  • Biogen sells PRV: CFO Michael McDonnell said the company completed the sale of one of its two priority review vouchers. It sold for $103 million to an undisclosed third party. A spokesperson told Endpoints News that the sale was “finalized this morning,” and more details will be disclosed post-market.
  • Multiple sclerosis is still core: When asked by an analyst if Biogen is diversifying away from the therapeutic category, given its recent business development activities, Viehbacher said Biogen “hasn’t abandoned MS.” The company has long been known for its MS franchise. It’s still running programs in early research. “The unmet need in MS has really narrowed,” he said. “It’s really the progressive form, which is a very tough indication to go after.”
  • The future of its biosimilar business is still up in the air: McDonnell said the company has “not received an acceptable offer from a third party” to sell its biosimilar business, which has been under review for about a year. “Our process remains ongoing, and we will remain disciplined as we continue to explore all options, including retaining the business,” he added. The business brought in $197 million in first-quarter revenue, a 2% increase over the same period in 2023.
  • No pipeline changes: After removing various therapeutic assets and digital health studies over the past few years, Biogen said it had no pipeline changes in the most recent quarter.

Viewing all articles
Browse latest Browse all 2046

Trending Articles