- Despite recording double-digit revenue growth in the second quarter, Celgene wasn't able to shake investor concerns about its portfolio and spent much of a Thursday earnings call fielding questions on late-stage assets that could give the big biotech a boost over the next few years.
- Total revenue rose 17% year over year to hit $3.8 billion for the quarter. Revlimid continued to contribute the lion's share, with sales rising 21% to nearly $2.5 billion, while Celgene's other blood cancer drug Pomalyst notched a strong performance of its own — achieving $507 million in sales, or 30% growth compared to the same period in 2017.
- Along with the results, Celgene raised annual revenue guidance from around $14.8 billion to $15 billion. It also highlighted five pipeline candidates it expects to launch before 2020's end: ozanimod for multiple sclerosis, fedratinib for myelofibrosis, luspatercept for blood disorders, bb2121 for multiple myeloma and liso-cel for blood cancers.
Revenue growth of 17% would typically be welcome among biopharma investors. But Celgene's not a typical company, underscored by the fact its shares were higher by a little more than 1% at Thursday's market open.
For years, the bulk of the biotech's revenue has come from Revlimid (lenalidomide). In itself that's not the biggest of problems, yet Celgene hasn't — at least until recently — built up a slate of late-stage assets that could offset the declines expected when its top-seller eventually loses patent protection (slated for early 2022 in the U.S.).
During their earnings call, executives made sure to showcase the progress Celgene's made on that front.
The company plans to file fedratinib, a Janus kinase 2 inhibitor picked up through its potentially $7 billion acquisition of Impact Biomedicines, before the end of 2018. They're also looking to investigate the drug in combination with luspatercept, a first-in-class red blood cell maturation agent that recently scored positive results in Phase 3 studies of patients with myelodysplastic syndromes and beta-thalassemia, respectively. Celgene intends to submit the latter drug to U.S. and European regulators during the first half of 2019.
Filings for Celgene's closely watched multiple sclerosis treatment ozanimod are also set for early next year. The drug's development pathway has had some surprises, including the finding that its efficacy stems almost entirely from a metabolite — which in turn caused the Food and Drug Administration to deny a review until more information about the metabolite was known.
Still, Celgene has high hopes for the drug and its ability to compete with a market of heavy-hitters like Teva Pharmaceutical's Copaxone (glatiramer acetate), Biogen's Tecfidera (dimethyl fumarate) and, in particular, Novartis' Gilenya (fingolimod), which also acts on sphingosine‐1‐phosphate receptors. Novartis is currently moving to get a lower dose of Gilenya approved.
"I think as we look at the clinical data, the Phase 3 program for ozanimod ... we really do see very clear differentiation from both Gilenya as well as the low dose, particularly when you look at the cardiovascular profile and the safety profile," said Terran Curran, Celgene's president of inflammation and immunology, on the call.
Further out, Celgene expects to secure approval for its CAR-T therapy bb2121 in highly refractory multiple myeloma patients in 2020. While analysts have inquired about the potential overlap in the company's multiple myeloma treatments, executives believe there's enough room in the market.
"Within BCMA, I think we're uniquely positioned because we have both CAR-T approaches as well as antibody approaches," Nadim Ahmed, Celgene's president of hematology and oncology, said on the call.