When it comes to healthcare events, there is none more important than the JPMorgan Healthcare Conference. Filled with dozens upon dozens of biotech and medical device companies, the JPMorgan Healthcare Conference, coming up in mid-January, is the perfect time for companies to unveil a study or device they've been keeping under their thumb for a rainy day.
With this in mind, we asked three of our top healthcare analysts to name one biotech stock they'd be closely watching in advance of the JPMorgan Healthcare Conference. Here what they had to say.
Brian Orelli: There are always a few companies with clinical trial data and a few deals that get announced at JP Morgan, but it's hard to guess which companies might have news.
Guidance for clinical trial data is usually vague -- "early 2015" or the even more obscure "first quarter" -- and there's no reason companies should hold data for JP Morgan. The data is material news and should be released to shareholders once it's known. Some companies are either breaking the SEC rules, or somehow managing to complete their data analysis just in the nick of time and have to release their data at JP Morgan.
It's more understandable how deals could be announced at JP Morgan, as both sides are inclined to consummate a deal before the big meeting, but predicting who might get together is difficult.
There is one constant at JP Morgan, however: Celgene (NASDAQ:CELG) earnings. The company typically gives tentative results for the previous quarter and guidance for the year ahead.
Last year, Celgene gave some longer-term guidance, predicting 2015 sales between $8.5 billion and $9.5 billion rising to between $13 billion and $14 billion in 2017. That's a 21% compounded annual growth rate at the midpoint. Earnings per share are expected to grow even faster, at around 26% per year.
It will be interesting to see if Celgene raises that guidance. Keep in mind, though, that management tends to be conservative. Last year at JP Morgan, the company guided for split-adjusted earnings of $3.50 to $3.60 per share in 2014, but the yearly guidance was bumped up a couple of times during the year; on its third-quarter conference call, management guided for earnings of $3.65 to $3.70 per share for the year.
Cheryl Swanson: There's a good reason the JP Morgan Healthcare Conference is often called the Super Bowl of healthcare. It's the biggest healthcare meeting of the year with pharma giants and small/mid-cap biotechs huddling up to listen to presentations and talk up deals.
One company that could emerge a winner at this year's conference is small-cap Amicus Therapeutics (NASDAQ:FOLD). Amicus is in the midst of a comeback and will be presenting positive Phase III results for its Fabry treatment.
Amicus lost a big chunk of its market cap after the Fabry treatment failed in a previous pivotal trial. But the company never gave up on the drug, and in a revised investigation, it proved itself a success last month.
Deep-pocketed partner GlaxoSmithKline gave back commercialization rights after the drug's previous study ended in failure, and Amicus has said it's open to new partners. The small-cap biotech market has plenty of perils, but with a Phase III victory in the bag, an EU approval filing coming up mid-year, and the U.S. hopefully to follow, Amicus will no doubt try to set the bar high.
Beyond its lead candidate, Amicus will also presenting data on a drug nearing the clinic for patients not eligible for Fabry.
Intercept had a wild ride in 2014. In January, its shares practically quintupled overnight after a midstage study for obeticholic acid, or OCA, was suggested to be stopped early by a data safety monitoring board due to statistically significant efficacy as a treatment for nonalcoholic steatohepatitis, a liver disease affecting up to 12% of the population.
However, since then, Intercept has given back much of its gains, with the FLINT trial data pointing to potentially worrisome elevated cholesterol levels in patients. Additionally, The Lancet suggested Intercept may need to run additional trials to demonstrate OCA's safety.
I'll be specifically looking for two things from Intercept at the JPMorgan Healthcare Conference. First, I'm hoping management will discuss their strategy moving forward with OCA. The POISE trial involving OCA as a treatment for primary biliary cirrhosis met its primary endpoint, but the filing date of a new drug application is still unknown beyond "the first half of 2015." It would also be great if management addressed some of the concerns surrounding OCA's safety.
Secondly, I'm looking for fresh studies to be published that might expand OCA's label or introduce investors to additional preclinical compounds. As it stands now, Intercept's entire clinical pipeline is based on OCA for three separate indications. Beyond that, it has two other product candidates in preclinical studies. If Intercept is to be taken seriously by investors, it's going to need some pipeline depth.
This year is certainly shaping up to be volatile once again for Intercept, and it all starts with the JPMorgan Healthcare Conference.
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