Biogen (BIIB) earnings This autumn 2023
A Biogen facility in Cambridge, Massachusetts.
Brian Snyder | Reuters
Biogen on Tuesday reported fourth-quarter income and revenue that shrank from a 12 months in the past, because it recorded prices associated to dropping its controversial Alzheimer’s drug Aduhelm and as gross sales slumped in its multiple sclerosis therapies, the corporate’s largest drug class.
Biogen booked gross sales of $2.39 billion for the quarter, down 6% from the identical interval a 12 months in the past. It reported internet revenue of $249.7 billion, or $1.71 per share, for the fourth quarter, down from internet revenue of $550.4 billion, or $3.79 per share, for a similar interval a 12 months in the past. Adjusting for one-time gadgets, the corporate reported $2.95 per share.
The drugmaker’s fourth-quarter earnings per share, each unadjusted and adjusted, noticed a unfavorable affect of 35 cents related to beforehand disclosed prices of pulling Aduhelm, which had a polarizing approval and rollout within the U.S.
Biogen is chopping prices whereas pinning its hopes on its different Alzheimer’s medicine, together with its carefully watched remedy Leqembi, and different newly launched merchandise to exchange declining income from its a number of sclerosis therapies.
This is what Biogen reported for the fourth quarter in contrast with what Wall Avenue was anticipating, primarily based on a survey of analysts by LSEG:
- Earnings per share: $2.95 adjusted vs. $3.18 anticipated
- Income: $2.39 billion vs. $2.47 billion anticipated
Additionally on Tuesday, Biogen issued full-year 2024 steerage that requires adjusted earnings of $15 to $16 per share. Analysts surveyed by LSEG had anticipated full-year earnings steerage of $15.65 per share.
The drugmaker mentioned it expects 2024 gross sales to say no by a low to mid-single digit share in comparison with final 12 months. However the firm expects its pharmaceutical income, which incorporates product income and its 50% share of Leqembi gross sales, to be flat this 12 months in comparison with 2023.
A number of sclerosis drug gross sales droop
Biogen’s fourth-quarter income from a number of sclerosis merchandise fell 8% to $1.17 billion as among the therapies face competitors from cheaper generics.
The corporate’s once-blockbuster drug Tecfidera, which is dealing with competitors from a generic rival, posted income that fell 17.8% to $244.3 million within the fourth quarter. Analysts had anticipated that drug to e-book gross sales of $233.1 million, in keeping with FactSet.
Vumerity, an oral medicine for relapsing types of a number of sclerosis, generated $156.4 million in gross sales. That got here in beneath analysts’ estimates of $174.4 million, FactSet estimates mentioned.
“We have had a number of years of declining income and revenue, which isn’t uncommon if you’re coping with patent expirations,” Biogen CEO Christopher Viehbacher informed reporters on a media name Tuesday. He added that one of many key methods Biogen will return to progress is to “reposition the corporate away from our legacy franchise of a number of sclerosis in direction of new merchandise.”
In the meantime, Biogen’s uncommon illness medicine recorded $471.8 million in gross sales, up 3% from the identical interval a 12 months in the past.
Spinraza, a drugs used to deal with a uncommon neuromuscular dysfunction referred to as spinal muscular atrophy, recorded $412.6 million in gross sales. That got here beneath analysts’ estimate of $443.4 million in income, in keeping with FactSet.
Biogen’s biosimilar medicine booked $188.2 million in gross sales, up 8% from the year-earlier interval. Analysts had anticipated gross sales of $196.7 million from these medicines.
Leqembi, different new medicine
The outcomes come amid the rollout of Biogen and Eisai’s Leqembi, which turned the primary drug discovered to sluggish the development of the illness to win approval within the U.S. in July.
Eisai, which reported earnings final week, recorded $7 million in fourth-quarter income and $10 million in full-year gross sales from Leqembi.
Biogen CEO Christopher Viehbacher informed reporters on a media name Tuesday that there are round 2,000 sufferers at the moment on Leqembi. That makes Biogen’s goal of 10,000 sufferers by the top of March 2024 look more and more troublesome to hit, however Viehbacher emphasised that the corporate is targeted extra on the long-term attain of Leqembi relatively than assembly that benchmark.
“I feel what’s vital is we at the moment are making progress,” he informed reporters. “The ten,000 is not actually exhausting and I feel we at the moment are actually specializing in industrial plans — how can we get to the subsequent 100,000?”
Notably, the low fee of adoption is not because of lack of demand: There are some 8,000 U.S. sufferers at the moment ready to get on remedy, executives from Eisai mentioned on an earnings name final week.
The businesses are additionally working towards Meals and Drug Administration approval of an injectable version of Leqembi, which confirmed promising preliminary ends in a medical trial in October.
Leqembi is at the moment administered twice month-to-month by the veins, a technique often called intravenous infusion. The injectable type can be a brand new and extra handy choice for administering the antibody remedy to sufferers, which might pave the best way for larger uptake.
However traders even have their eyes on different newly launched medicine.
That features Skyclarys from Biogen’s acquisition of Reata Prescription drugs in July. That drug introduced in $56 million in fourth-quarter income, in keeping with Biogen.
The FDA cleared Skyclarys final 12 months, making it the primary authorized remedy for Friedreich ataxia, a uncommon inherited degenerative illness that may impair strolling and coordination in youngsters as younger as 5.
On Monday, EU regulators approved Skyclarys for the remedy of Friedreich ataxia in sufferers ages 16 and up.
Biogen has additionally partnered with Sage Therapeutics on the primary capsule for postpartum despair, which received FDA approval in August. However the company declined to clear the drug for main depressive dysfunction, which is a far bigger industrial alternative.
Biogen mentioned that capsule, referred to as Zurzuvae, generated roughly $2 million in gross sales for the fourth-quarter.
This story is growing. Please examine again for updates.
