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Tuesday, April 30, 2019

Increasing Revlimid Sales Drive Strong Quarter for Celgene

In what could be its final quarterly report before becoming part of the Bristol-Myers Squibbfamily, Celgene posted revenue of $4.02 billion, a growth of 18 percent over the first quarter of 2018.
As could be expected, Celgene’s revenue was driven by its top performing drug, Revlimid, which was one of the key assets BMS had in mind when it plunked down $74 billion in January for the company. Revlimid, which earned nearly $10 billion in revenue for Celgene last year, will lose about 60 percent of its earning power over the next seven years as patent protection drops. However, that patent protection has yet to drop and the cancer drug continued to be a strong driver for the company. In the first quarter, Revlimid raked in $2.5 billion, an increase of 15 percent year-over-year, the company said.
Pomalyst, which was also another drug that drew the eye of BMS, also saw strong growth during the quarter. Pomalyst, a treatment for multiple myeloma, brought in $557 million during the first quarter, an increase of 23 percent year-over-year. Other strong revenue drivers were Abraxane and Otezla, which generated $286 million and $389 million, respectively during the quarter. Both drugs saw sales growth of 9 and 10 percent, respectively.
Mark Alles, chairman and chief executive officer of Celgene, said the company delivered “strong top-and bottom-line growth while advancing our innovative pipeline with multiple regulatory submissions in the U.S. and EU.”
“Our excellent operating performance continues to generate positive momentum into the expected closing of the Bristol-Myers Squibb transaction during the third quarter of 2019,” Alles said in a brief statement.

Earlier this month Celgene and BioSpace stakeholders overwhelmingly supported the acquisition, despite opposition of some shareholder groups. That opposition seemed to wane ahead of the April 12 shareholder vote after proxy advisory firm Institutional Shareholder Services came out in support of the deal.
While Revlimid may remain a concern for some shareholders, Celgene has a deep pipeline with potential revenue drivers, as well as multiple partnerships that could provide significant revenues. For example, in April, Celgene and Acceleron Pharma announced the submission of a BLA to the U.S. Food and Drug Administration for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions.
Celgene also submitted a New Drug Application in March for ozanimod in patients with relapsing forms of multiple sclerosis. Also in March, the FDA granted Priority Review designation for the NDA for fedratinib in patients with myelofibrosis. The FDA is set to make a decision on that drug by Sept. 3.
The company has had some setbacks during the first part of the year. In addition to its quarterly report, Celgene also announced top-line results from the phase III ROBUST trial evaluating Revlimid plus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated activated B-cell (ABC) subtype diffuse large B-cell lymphoma (DLBCL). The trial failed to meet the primary endpoint of demonstrating superiority in progression-free survival (PFS) compared to placebo.
As the closing date for completing the acquisition nears, Celgene reported in its quarterly announcement that it’s planning on several data presentations at coming medical conferences, including the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Some of the data the company will present include late-stage data from the apact trial evaluating Abraxane as adjuvant therapy in patients with surgically resected pancreatic cancer. In March, Celgene announced that the Phase III apact trial did not achieve the primary endpoint of improvement in disease-free survival, compared to gemcitabine alone. Overall survival, a secondary endpoint of the study, was improved, reaching nominal statistical significance.

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