stock dropped sharply Thursday after the biotech giant said in a presentation that the launch of controversial Alzheimer’s disease drug, Aduhelm, “was slower than we initially anticipated.”
“Although we are facing some near-term challenges and everybody can see that, we continue to see a very high level of physician and patient interest and we continue to believe the mid- to long-term opportunity remains significant,” said
(ticker: BIIB) CEO Michel Vounatsos in a presentation at the Morgan Stanley Global Healthcare Conference.
“In addition to the launch in the U.S., Aduhelm is now filed in many geographies, and we are pleased to report the recent regulatory approval in the UAE,” the CEO added, according to a conference transcript.
Back in late July, Biogen unveiled sales figures for the drug that fell slightly short of analysts’ expectations. The company previously warned that the rollout would take time.
The blowback against the approval for Aduhelm peaked earlier that month when the Food and Drug Administration’s acting commissioner asked the acting inspector general of the Department of Health and Human Services to review the drug’s approval process.
Vounatsos said at the conference that the company “stands behind our clinical data for the eight studies with more than 3,000 patients that supported the accelerated approval, and we stand behind the integrity of the review process.”
The company said it was advancing three studies to generate additional data.
Alisha Alaimo, Biogen’s president of U.S. operations, addressed concerns about the Aduhelm data and the approval process. She said questions about the approval process have “been more pervasive than we originally anticipated.
“Our commercial, market access and medical teams are working with an incredible sense of urgency to communicate our clinical data. And once it is published, we’ll appropriately disseminate the manuscripts on our Phase III trials, which we believe will enable a data-centric conversation and better inform clinical practice,” Alaimo added.
Analysts at Jefferies acknowledged Thursday that early challenges to Aduhelm weren’t positive. But they added they weren’t “totally unexpected, and we agree it will take time.
“With stock down at $300 and sentiment very negative, we think it’s an attractive opportunity, though think Street might not pay attention until closer to (January national coverage determination) decision and more time for logistical rollout of drug,” the analysts added.
Jefferies analysts rate the stock a Buy with a price target of $500.
RBC analyst Brian Abrahams wrote in a note Thursday that Biogen said it was aware of just 50 sites currently infusing the drug – “only a sliver of the 900 centers they expected would be ready to infuse shortly after adu’s approval.”
He added, like the Jefferies analysts, that he doesn’t believe “these dynamics will come as a major surprise to those following the story or the headlines.”
“While management acknowledgement of the significant Aduhelm launch hurdles is unlikely to be a major surprise, and the stock is already now starting to reflect much more pessimism about Aduhelm uptake and competitive impact, we do believe it underscores the limited potential for meaningful upside drivers between now and the quarters post” a national coverage determination) decision.
Abrahams rates the stock at Sector Perform with a price target of $341.
Biogen shares closed down 6.66% on Thursday to $300.15. The stock has risen more than 22% year to date but has been sliding over the past week.
Thirty-two analysts surveyed by FactSet rate the stock Overweight with an average price target of $425.20.
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