Celgene Primed For Growth Through 2017, Hugin Says At JPM
This article was originally published in The Pink Sheet Daily
Executive Summary
Celgene CEO Bob Hugin gave investors a taste of what’s to come for the biotech as it prepares for multiple NDA filings this year and the influx of data on several new indications for its lead drugs.
Celgene Corp. expects to be a strong growth story over the next five years as three of its franchises are set to achieve milestones, as well as get further regulatory approvals. Celgene Chairman and CEO Robert Hugin laid out the biotech’s goals at the J.P. Morgan Healthcare conference in San Francisco on Jan. 7.
During his presentation, Hugin pre-announced some of Celgene’s results for the fourth quarter and 2012 – telling investors that the multiple myeloma treatment Revlimid (lenalidomide) is expected to produce revenues of about $1 billion for the fourth quarter, in line with analyst estimates. The drug is expected to bring in between $4.1 billion to $4.2 billion in revenues in 2013, slightly below consensus.
Hugin gave indications that the company is planning to grow by quite a bit over the next five years, reaching total revenues greater than $12 billion in 2017 and earnings per share of $13 to $14. This doubling of the company’s sales will rely heavily on its late-stage psoriasis drug apremilast.
“There is a real tangible feeling of acceleration in all of our research programs and we are very proud of the productivity that we're producing in these programs, both internally and with our important collaborators,” said Hugin. “Overall, I think 2012 was a year of great positive results and importantly positioning us today with three new blockbuster potential products and two new blockbuster franchises that are really now being turned from promise into reality for Celgene.”
Hugin told investors at the conference that Celgene achieved statically significant results in ESTEEM I & II, two Phase III trials of apremilast in 1,250 patients with psoriasis. While Hugin gave no other details about the results of the trial, the analysis will be presented at an upcoming medical meeting. The company is expected to submit regulatory applications in the U.S. and Canada for apremilast for the treatment of psoriatic arthritis in the first quarter, with an NDA for the psoriasis application to follow in the second half of the year.
Strong Expectations For Oncology And Hematology
New indications for the cancer drug Abraxane (paclitaxel) are going to be pursued by Celgene over the coming year; the drug already is approved in breast cancer and lung cancer.
“Clearly, Abraxane with pancreatic [cancer] and melanoma provides us the opportunity to increase our growth rate over the next five years,” said Hugin at the conference. “Abraxane showed clear differentiated advantage, clinically meaningful opportunity – advantage in diseases where Taxane had previously never shown activity. And we are working very hard to get the drug approved in these new indications as quickly as possible.”
The drug, which previously was approved in 2005 for metastatic breast cancer, got further clearance from FDA in October for the treatment of first-line advanced non-small cell lung cancer (Also see "Abraxane Lung Cancer Approval Comes With Questionable Commercial Value" - Pink Sheet, 12 Oct, 2012.). In November, the biotech announced that a Phase III trial of Abraxane in pancreatic cancer patients showed an overall survival benefit. Further data on the drug in pancreatic cancer are expected later this month at ASCO GI and an sNDA in pancreatic cancer will be submitted before the middle of the year. Further data on the melanoma indication are expected by year-end.
Beyond that, investors eagerly are awaiting an FDA decision on the company’s relapsed/refractory multiple myeloma treatment Pomalyst (pomalidomide), which is expected Feb. 10 (Also see "Celgene’s Pomalidomide Faces Review, With Confirmatory Trial Waiting In Wings" - Pink Sheet, 27 Sep, 2012.). “Pomalyst has the potential to be our next blockbuster. It is a drug that was discovered in our laboratories, developed throughout our clinical and regulatory organizations and will be commercialized globally by our organization. It has a very differentiated mechanism and has strong, strong data. We’re working hard to accelerate its regulatory approvals around the world,” said Hugin.