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A Biogen manufacturing unit in Cambridge, Massachusetts.
Brian Snyder | Reuters
Biogen on Tuesday reported fourth-quarter income and revenue fell from a 12 months in the past as the corporate recorded expenses associated to the drop of its controversial Alzheimer’s drug Aduhelm and when gross sales in his nation dropped therapies for a number of sclerosisthe corporate’s largest drug class.
Biogen posted income of $2.39 billion this 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. Adjusted for one-time objects, the corporate reported $2.95 per share.
The drugmaker’s fourth-quarter earnings per share, each unadjusted and adjusted, had been negatively impacted by 35 cents associated to beforehand disclosed expenses for the withdrawal of Aduhelm, which had a polarizing approval and rollout within the US.
Biogen is chopping prices because it pins its hopes on its different Alzheimer’s medication, together with intently watched remedy Leqembi, and different newly launched merchandise to switch declining revenues from its a number of sclerosis therapies.
Shares of Biogen fell 5% in early buying and selling on Tuesday.
That is what Biogen reported for the fourth quarter in comparison with what Wall Road anticipated, primarily based on a survey of analysts by LSEG:
Earnings per share: $2.95 adjusted vs. $3.18 expectedSales: $2.39 billion vs. $2.47 billion anticipated
Additionally on Tuesday, Biogen launched steerage for full-year 2024, calling for adjusted earnings of $15 to $16 per share. Analysts polled by LSEG anticipated full-year earnings of $15.65 per share.
The drugmaker stated it expects gross sales to say no by a low to mid-single digit share in 2024 in comparison with final 12 months. However the firm expects its pharmaceutical gross sales, together with product gross sales and its 50% share of Leqembi gross sales, to stay flat this 12 months in comparison with 2023.
Gross sales of a number of sclerosis medication are declining
Biogen’s income from a number of sclerosis merchandise fell 8% to $1.17 billion within the fourth quarter as some therapies face competitors from cheaper generics.
The corporate’s once-successful drug Tecfidera, which is going through competitors from a generic rival, posted gross sales that fell 17.8% to $244.3 million within the fourth quarter. Analysts had anticipated the drug to put up gross sales of $233.1 million, based on FactSet.
Vumerity, an oral drug for relapsed types of a number of sclerosis, generated gross sales of $156.4 million. That got here in decrease than analyst estimates of $174.4 million, based on FactSet estimates.
“We have had a number of years of declining gross sales and earnings, which isn’t uncommon if you’re coping with patent expirations,” Biogen CEO Christopher Viehbacher instructed reporters on a media name on Tuesday. He added that one of many key methods Biogen will return to progress is to “reposition the corporate away from our legacy a number of sclerosis franchise and towards new merchandise.”
In the meantime, Biogen’s uncommon illness medication posted income of $471.8 million, up 3% from the identical interval a 12 months in the past.
Spinraza, a drug used to deal with a uncommon neuromuscular situation known as spinal muscular atrophy, posted gross sales of $412.6 million. That got here in beneath analysts’ estimates of $443.4 million in income, based on FactSet.
Biogen’s biosimilar medicines posted gross sales of $188.2 million, up 8% from the identical interval final 12 months. Analysts had anticipated gross sales of $196.7 million from these medication.
Leqembi, different new medication
The outcomes come throughout the rollout of Biogen and Eisai’s Leqembi, the primary drug discovered to sluggish the development of the illness, gaining approval within the US in July.
Eisai, which reported earnings final week, recorded $7 million in fourth-quarter income and $10 million in full-year income from Leqembi.
Biogen CEO Christopher Viehbacher instructed reporters on a media name Tuesday that there are about 2,000 sufferers presently taking Leqembi. That makes Biogen’s purpose of 10,000 sufferers by the top of March 2024 look more and more tough to attain, however Viehbacher emphasised that the corporate is targeted extra on Leqembi’s long-term attain than on hitting that benchmark.
“I believe a very powerful factor is that we’re making progress now,” he instructed reporters. “The ten,000 isn’t actually tough and I believe we’re actually specializing in industrial plans now. How will we get to the following 100,000?”
Notably, the low adoption fee is not resulting from a scarcity of demand: There are about 8,000 U.S. sufferers presently ready for remedy, Eisai executives stated throughout an earnings name final week.
The businesses are additionally working towards Meals and Drug Administration approval for an injectable model of Leqembi, which confirmed promising early ends in a medical trial in October.
Leqembi is presently given twice a month by the veins, a technique referred to as intravenous infusion. The injectable type would offer a brand new and simpler possibility for delivering the antibody remedy to sufferers, which might pave the way in which for greater uptake.
However buyers even have their eyes on different newly launched medication.
That features Skyclarys from Biogen’s acquisition of Reata Prescription drugs in July. That drug generated $56 million in fourth-quarter gross sales, based on Biogen.
The FDA permitted Skyclarys final 12 months, making it the primary permitted remedy for Friedreich ataxia, a uncommon inherited degenerative illness that may impair strolling and coordination in youngsters as younger as 5 years previous.
On Monday, EU regulators stated permitted Skyclarys for the remedy of Friedreich ataxia in sufferers aged 16 years and older.
Biogen additionally collaborates with Sage Therapeutics in regards to the first capsule for postpartum despair, which was permitted by the FDA in August. However the company declined to clear the drug for depressive problems, which is a a lot larger industrial alternative.
Biogen stated that capsule, known as Zurzuvae, generated about $2 million in gross sales within the fourth quarter.
Biogen (BIIB) This autumn 2023 Earnings
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