It's always more fun to stand in front of a group fresh on the heels of a major success. Unfortunately, that wasn't the case for Celgene (CELG +0.00%) CEO Mark Alles as he helped kick off the annual J. P. Morgan Healthcare Conference in San Francisco on Monday. The big biotech had a rough 2017, with the stock dropping nearly 10%.
Even a major acquisition announced by Celgene right before the conference wasn't enough to excite investors. Celgene reported that it was buying privately held biotech Impact Biomedicines on Sunday, but Celgene shares fell more than 3% in early trading the following day.
Still, though, there was some good news from Celgene at the J. P. Morgan event. Here are five things you need to know from the biotech's presentation.
Image source: Getty Images.
1. Why it's buying Impact Biomedicines
Celgene will spend $1.1 billion up front and potentially as much as $7 billion with milestone payments included to buy Impact Biomedicines. Investors probably weren't excited for a couple of reasons. First, Impact's fedratinib targets treatment of myelofibrosis (MF), an indication dominated currently by Incyte's (INCY +1.85%) Jakafi. Second, there are some potential safety concerns for fedratinib after it was placed on clinical hold last year.
Alles said that Impact is "a very important" addition to Celgene, though. He acknowledged that Jakafi is the market leader. However, Celgene believes that fedratinib still has blockbuster potential in treating relapsed myelofibrosis. Around 20% of all MF patients are those who didn't respond well to Jakafi.
Potential safety issues don't concern Celgene too much. The FDA ultimately lifted its clinical hold in August 2017. Alles said that fedratinib is a "ready-to-submit product." Celgene expects to file for approval by mid-2018.
2. Otezla is stronger than you might think
Celgene's dismal stock performance last year was driven in part by lower-than-expected sales for Otezla. But if you think the autoimmune disease drug is going to be a drag for the biotech, think again. Alles stated that Otezla is positioned well for continued strong growth.
He referred to Otezla's current market position as the No. 1 psoriasis drug in new-to-brand market share. It's also the top pre-biologic for treating psoriasis and ranks third in market share among all psoriasis drugs. Most importantly, though, Alles noted the significant untapped opportunity for Otezla, with around 60% of diagnosed psoriasis patients remaining untreated.
Alles also pointed to additional indications for the drug. Celgene already reported late-stage data for Otezla in treating Behcet's disease and phase 2 results in treating ulcerative colitis. The company also plans to initiate late-stage studies in added psoriasis indications.
3. Expect ozanimod to shake things up in the multiple sclerosis market
Celgene has high expectations for ozanimod. The company hopes to win FDA approval later this year for the drug in treating relapsed multiple sclerosis (MS). If ozanimod does win approval as expected, Alles indicated that the company thinks it will shake things up in the MS market.
In particular, ozanimod is likely to give Biogen's Tecfidera a run for its money. Ozanimod's safety profile appears to be best-in-class, which could give it an advantage over Tecfidera. In addition, Celgene could be well-positioned to compete against other MS drugs to a lesser extent, including Aubagio, Copaxone, and Gilenya.
Inflammatory bowel disease (IBD) could be another great opportunity for ozanimod. Alles said that results from a late-stage study of the drug in treating ulcerative colitis are expected in the second half of 2019. Celgene is also starting a late-stage study targeting Crohn's disease and plans to initiate another late-stage study this year evaluating ozanimod in treating ulcerative colitis.
4. More solid growth on the way
Although investors were disappointed by Celgene stock's performance last year, the company should report pretty strong results when it announces fourth-quarter and full-year 2017 figures. Alles said that Celgene expects to post full-year 2017 revenue of $13 billion -- up 16% from the previous year. He also gave encouraging guidance for 2018.
Celgene anticipates 2018 revenue growth of at least 12%. While that's slower than the last few years, it's not bad. The company projects that Revlimid will generate sales of $9.4 billion this year, up nearly 15% year over year. Pomalyst is expected to bring in around $1.9 billion, 18% higher than its 2017 sales level. Celgene thinks that Otezla will make roughly $1.5 billion -- a 17% increase from last year. And Abraxane should finally become a blockbuster after narrowly missing in 2017, with expected 2018 sales of around $1 billion.
Continued growth for its lead products should help Celgene increase adjusted earnings per share in 2018 by 18% year over year. That's close to the company's goal of average annual earnings growth of around 19% through 2020.
5. Long-term future looks bright -- even with Revlimid losing exclusivity
Some investors might be worried about what will happen to Celgene after the company loses exclusivity for its powerhouse blood cancer drug Revlimid. Alles, on the other hand, was optimistic.
He said that Celgene believes it will launch 10 potential blockbusters over the next five years that could add over $15 billion in incremental annual revenue at the drugs' peak levels. Obviously, ozanimod is on that list. Three other pipeline candidates are expected to be megablockbusters -- luspatercept, bb2121, and CC-220.
It's key to note that two of those anticipated huge winners stem from partnerships. Luspatercept was originally developed by Acceleron Pharma, while bb2121 is licensed by Celgene from partner bluebird bio.
Acquisitions are also important to Celgene's future. Ozanimod was picked up with the company's purchase of Receptos in 2015. Assuming Celgene's acquisition of Impact wraps up as expected, fedratinib could be yet another blockbuster gained through a buyout.
The bottom line, according to Mark Alles, is that Celgene has a strategy to deliver growth through 2020 and beyond. Will Celgene achieve its goals? I wouldn't underestimate this big biotech.
