A motion for biotechnology company, Biogen, Inc. is seen connected a gathering successful Cambridge, Massachusetts,
Dominick Reuter/AFP via Getty ImagesText size
Biogen banal was dropping sharply Thursday aft the biotech elephantine said successful a presumption that the motorboat of arguable Alzheimer’s illness drug, Aduhelm, “was slower than we initially anticipated.”
“Although we are facing immoderate near-term challenges and everybody tin spot that, we proceed to spot a precise precocious level of doc and diligent involvement and we proceed to judge the mid- to semipermanent accidental remains significant,” said Biogen (ticker: BIIB) CEO Michel Vounatsos in a presumption astatine the Morgan Stanley Global Healthcare Conference.
“In addition to the motorboat successful the U.S., Aduhelm is present filed successful galore geographies, and we are pleased to study the caller regulatory support successful the UAE,” the CEO added, according to a league transcript.
Back successful precocious July, Biogen unveiled income figures for the cause that fell somewhat abbreviated of analysts’ expectations. The institution antecedently warned that the rollout would instrumentality time.
The blowback against the approval for Aduhelm peaked earlier that period erstwhile the Food and Drug Administration’s acting commissioner asked the acting inspector wide of the Department of Health and Human Services to reappraisal the drug’s support process.
Vounatsos said astatine the league that the institution “stands down our objective information for the 8 studies with much than 3,000 patients that supported the accelerated approval, and we basal down the integrity of the reappraisal process.”
The institution said it was advancing 3 studies to make further data.
Alisha Alaimo, Biogen’s president of U.S. operations, addressed concerns astir the Aduhelm data and the support process. She said questions astir the support process have “been more pervasive than we primitively anticipated.
“Our commercial, marketplace entree and aesculapian teams are moving with an unthinkable consciousness of urgency to pass our objective data. And erstwhile it is published, we’ll appropriately disseminate the manuscripts connected our Phase III trials, which we judge volition alteration a data-centric speech and amended pass objective practice,” Alaimo added.
Analysts astatine Jefferies acknowledged Thursday that aboriginal challenges to Aduhelm weren’t a positive. But they added they weren’t “totally unexpected, and we hold it volition instrumentality time.
“With banal down astatine $300 and sentiment precise negative, we deliberation it’s an charismatic opportunity, though deliberation Street mightiness not wage attraction until person to (January national sum determination) decision and much clip for logistical rollout of drug,” the analysts added.
Jefferies analysts complaint the banal a Buy with a terms people of $500.
RBC expert Brian Abrahams wrote successful a enactment Thursday that Biogen said it was alert of conscionable 50 sites presently infusing the cause – “only a sliver of the 900 centers they expected would beryllium acceptable to infuse soon aft adu’s approval.”
He added, similar the Jefferies analysts, that helium doesn’t judge “these dynamics volition travel arsenic a large astonishment to those pursuing the communicative oregon the headlines.”
“While absorption acknowledgement of the important Aduhelm motorboat hurdles is improbable to beryllium a large surprise, and the banal is already present starting to bespeak overmuch much pessimism astir Aduhelm uptake and competitory impact, we bash judge it underscores the constricted imaginable for meaningful upside drivers betwixt present and the quarters post” a nationalist sum determination) decision.
Abrahams rates the banal astatine Sector Perform with a terms people of $341.
Biogen shares fell 7.37% connected Thursday to $297.84. The banal has risen astir 22% twelvemonth to day but has been sliding implicit the past week.
Thirty-two analysts surveyed by FactSet complaint the banal Overweight with an mean terms people of $425.20.
Write to editors@barrons.com
English (US) ·