Teva to Launch Humira Biosimilar Amid Mixed Q1 Results
Following its FDA approval in February, Teva is set to launch Simlandi, a biosimilar to AbbVie's arthritis drug Humira, in the coming weeks. Separately, Teva reported earnings missing analysts' estimates, although revenue was up.
The following article originally appeared in Microsoft Start.
Teva Pharmaceutical Industries said it was set to launch its long awaited biosimilar of AbbVie's blockbuster arthritis drug Humira in the coming weeks after it posted mixed results in the first three months of 2024.
The drugmaker also said late-stage results for a new drug for schizophrenia met its primary endpoints, helping to push its New York-listed shares up more than 13% to their highest level since 2019 in late morning trade. It is developing the monthly injection with France's Medincell.
In the wake of February's U.S. Food and Drug Administration approval of Humira biosimilar Simlandi, Teva chief executive Richard Francis said the launch will be during the second quarter.
"I don't have exact timetables but it's imminent," he told Reuters, adding Teva has been in "lots and lots of discussions" with pharmacy benefit managers (PBMs) and payers.
"There could be a shift here where the market in the U.S. starts to really adopt biosimilars on a broader level" Francis said. "Let's see how this plays out for this year, but it's definitely encouraging."
Two of the largest PBMs - Cigna Group's Express Scripts and UnitedHealth Group's Optum RX - are only currently covering two or three Humira biosimilars for 2024 alongside the branded drug.
Teva plans to launch six biosimilar drugs by 2027, including Simlandi and psoriasis treatment Selarsdi, a copycat of Johnson & Johnson’s blockbuster drug Stelara. It developed both drugs with Alvotech.
The company said it earned 48 cents per share excluding one-time items in the first quarter, up from 40 cents per share a year earlier. Revenue rose 4% to $3.82 billion. Analysts had forecast earnings of 51 cents per share on revenue of $3.73 billion, LSEG data showed.
Teva reiterated its outlook of 2024 revenue of $15.7-$16.3 billion and adjusted EPS of $2.20-$2.50. In 2023, it posted revenue of $15.8 billion and adjusted EPS of $2.56.
Generic drug sales rose 9% globally in the quarter.
Teva, which is hoping 2024 will be a growth year, said U.S. sales of its Huntington's disease treatment Austedo jumped 67% in the quarter, while global sales of migraine drug Ajovy rose 18%.
It projects Austedo to hit sales of $1.5 billion in 2024, along with $500 million for Ajovy and $80 million for recently launched schizophrenia drug Uzedy. This trio of its own branded drugs, it believes, will help Teva bounce back from a rough few years.
Jefferies analyst Glen Santangelo, who rates Teva a "buy," said the company has not been getting credit from investors for its pipeline of innovative drugs and is being valued as a straight generic drugmaker.
"We think the market hasn't fully digested the changing DNA at Teva, but we believe today's and upcoming pipeline catalysts could represent a turning point," he said.
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