May 4, 2018 / 11:43 AM / 23 days ago

Celgene profit tops estimates; clarifies path for key MS drug

(Reuters) - Celgene Corp (CELG.O) reported much-needed, stronger-than-expected first quarter results as profit and sales of several drugs exceeded Wall Street forecasts, and the U.S. biotechnology company said it would re-apply for approval of an important multiple sclerosis treatment in early 2019.

Celgene shares rose as much as 4 percent.

A series of clinical setbacks and perceived management missteps took a heavy toll on Celgene shares, which have declined 42 percent since October. Perhaps most embarrassing was the February rejection for insufficient data by U.S. regulators of Celgene’s filing seeking approval of ozanimod, a MS drug seen as critical to lessening reliance on the flagship cancer treatment Revlimid.

The company said on Friday it now plans to re-submit the U.S. ozanimod application and apply for European approval in the first quarter of 2019.

“We are very confident the regulatory path for ozanimod is understood and back on track,” Chief Executive Mark Alles told analysts.

Jefferies analyst Michael Yee called the new plan “good enough” given fears it would be delayed until 2020.

Celgene said it expects to file for U.S. approval of fedratinib for myelofibrosis later this year, and for CAR-T therapy JCAR017 for blood cancers in 2019, treatments Celgene gained with recent acquisitions of Impact Biomedicines and Juno Therapeutics.

Celgene said it believes the two treatments will help make up for the later than originally expected launch of ozanimod, and it maintained its 2020 revenue targets.

    For the first quarter, Celgene posted adjusted earnings of $2.05 per share, topping analysts’ average expectations by 9 cents, according to Thomson Reuters I/B/E/S.

    Celgene now expects 2018 revenue at the high end of its $14.4 billion to $14.8 billion forecast.

    It sees 2018 adjusted earnings of $8.95 per share, up from its prior view of $8.70 to $8.90. That excludes the cost of the Juno acquisition, which would take full-year adjusted EPS down to about $8.45.

    Revlimid sales, driven by longer duration of use in multiple myeloma, rose about 19 percent to $2.23 billion, above analysts’ estimates of $2.21 billion.

    Sales of Otezla for psoriasis surged 46 percent to $353 million, helped by an aggressive U.S. television ad campaign. That also exceeded estimates, as did sales of cancer drugs Pomalyst at $453 million, and Abraxane at $262 million.

    Revenue rose 19.4 percent to $3.54 billion, topping estimates of $3.46 billion.

    Celgene shares rose 2.1 percent to $87.27 after earlier climbing as high a $88.88.

    Reporting by Bill Berkrot in New York and Akankshita Mukhopadhyay in Bengaluru; Editing by Sai Sachin Ravikumar and Nick Zieminski

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