A Biogen facility in Cambridge, Massachusetts.
Brian Snyder | Reuters
Biogen on Tuesday reported fourth-quarter revenue and profit that shrank from a 12 months ago, because it recorded charges related to dropping its controversial Alzheimer’s drug Aduhelm and as sales slumped in its multiple sclerosis therapies, the corporate’s biggest drug category.
Biogen booked sales of $2.39 billion for the quarter, down 6% from the identical period a 12 months ago. It reported net income of $249.7 billion, or $1.71 per share, for the fourth quarter, down from net income of $550.4 billion, or $3.79 per share, for a similar period a 12 months ago. Adjusting for one-time items, the corporate reported $2.95 per share.
The drugmaker’s fourth-quarter earnings per share, each unadjusted and adjusted, saw a negative impact of 35 cents related to previously disclosed costs of pulling Aduhelm, which had a polarizing approval and rollout within the U.S.
Biogen is cutting costs while pinning its hopes on its other Alzheimer’s drugs, including its closely watched treatment Leqembi, and other newly launched products to interchange declining revenue from its multiple sclerosis therapies.
Shares of Biogen fell nearly 7% in early morning Tuesday.
Here’s what Biogen reported for the fourth quarter compared with what Wall Street was expecting, based on a survey of analysts by LSEG, formerly often known as Refinitiv:
- Earnings per share: $2.95 adjusted vs. $3.18 expected
- Revenue: $2.39 billion vs. $2.47 billion expected
Also on Tuesday, Biogen issued full-year 2024 guidance that calls for adjusted earnings of $15 to $16 per share. Analysts surveyed by LSEG had expected full-year earnings guidance of $15.65 per share.
The drugmaker said it expects 2024 sales to say no by a low to mid-single digit percentage compared with last 12 months. But the corporate anticipates its pharmaceutical revenue, which incorporates product revenue and its 50% share of Leqembi sales, to be flat this 12 months compared with 2023.
Multiple sclerosis drug sales slump
Biogen’s fourth-quarter revenue from multiple sclerosis products fell 8% to $1.17 billion as a number of the therapies face competition from cheaper generics.
The corporate’s once-blockbuster drug Tecfidera, which is facing competition from a generic rival, posted revenue that fell 17.8% to $244.3 million within the fourth quarter. Analysts had expected that drug to book sales of $233.1 million, in line with FactSet.
Vumerity, an oral medication for relapsing types of multiple sclerosis, generated $156.4 million in sales. That got here in below analysts’ estimates of $174.4 million, FactSet estimates said.
“We have had several years of declining revenue and profit, which just isn’t unusual once you’re coping with patent expirations,” Biogen CEO Christopher Viehbacher told reporters on a media call Tuesday. He added that one in all the important thing ways Biogen will return to growth is to “reposition the corporate away from our legacy franchise of multiple sclerosis towards latest products.”
Meanwhile, Biogen’s rare disease drugs recorded $471.8 million in sales, up 3% from the identical period a 12 months ago.
Spinraza, a medicine used to treat a rare neuromuscular disorder called spinal muscular atrophy, recorded $412.6 million in sales. That got here under analysts’ estimate of $443.4 million in revenue, in line with FactSet.
Biogen’s biosimilar drugs booked $188.2 million in sales, up 8% from the year-earlier period. Analysts had expected sales of $196.7 million from those medicines.
Leqembi, other latest drugs
The outcomes come amid the rollout of Biogen and Eisai’s Leqembi, which became the primary drug found to slow the progression of the disease to win approval within the U.S. in July.
Eisai, which reported earnings last week, recorded $7 million in fourth-quarter revenue and $10 million in full-year sales from Leqembi.
Biogen CEO Christopher Viehbacher told reporters on a media call Tuesday that there are around 2,000 patients currently on Leqembi. That makes Biogen’s goal of 10,000 patients by the tip of March 2024 look increasingly difficult to hit, but Viehbacher emphasized that the corporate is targeted more on the long-term reach of Leqembi fairly than meeting that benchmark.
“I believe what’s vital is we are actually making progress,” he told reporters. “The ten,000 isn’t hard and I believe we are actually really specializing in business plans — how can we get to the subsequent 100,000?”
Notably, the low rate of adoption is not as a consequence of lack of demand: There are some 8,000 U.S. patients currently waiting to get on treatment, executives from Eisai said on an earnings call last week.
The businesses are also working toward Food and Drug Administration approval of an injectable version of Leqembi, which showed promising initial leads to a clinical trial in October.
Leqembi is currently administered twice monthly through the veins, a technique often known as intravenous infusion. The injectable form can be a latest and more convenient option for administering the antibody treatment to patients, which could pave the way in which for higher uptake.
But investors even have their eyes on other newly launched drugs.
That features Skyclarys from Biogen’s acquisition of Reata Pharmaceuticals in July. That drug brought in $56 million in fourth-quarter revenue, in line with Biogen.
The FDA cleared Skyclarys last 12 months, making it the primary approved treatment for Friedreich ataxia, a rare inherited degenerative disease that may impair walking and coordination in children as young as 5.
On Monday, EU regulators approved Skyclarys for the treatment of Friedreich ataxia in patients ages 16 and up.
Biogen has also partnered with Sage Therapeutics on the primary pill for postpartum depression, which won FDA approval in August. However the agency declined to clear the drug for major depressive disorder, which is a far larger business opportunity.
Biogen said that pill, called Zurzuvae, generated roughly $2 million in sales for the fourth-quarter.
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