The Medicines Company Will See Dynamic 2015, As Trials, Approvals Gain: Citi
Published: Feb 20, 2015
February 19, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
The Medicines Company will see a dynamic 2015, with several major pipeline "catalysts" and late-stage pipeline that has been bogged down by regulator approvals and litigation could soon have both those problems solved, Jonathan Eckard, a biotech analyst at Citi, said this week.
MDCO's 2014 revenue beat the Street, at $191 million versus a consensus of $189.8 million and Citi's estimate of $188.1 million. Generally accepted accounting principles earnings per share was $0.08 versus a consensus of $0.82 and Citi's $0.96. So far, the company has no provided any financial guidance for 2015, because investors are wary of ongoing litigation surrounding its blood clot drug Angiomax, though that could soon change, said Eckard.
"The focus for MDCO has been on the exclusivity of lead revenue driver Angiomax; however, there are multiple pipeline programs which, if catalysts fall the right way, could change how the Street views the outlook for the company," he wrote in a note to investors. "While we see several pipeline catalysts with potential to capture broader attention, many are hard to predict with markets that are not well understood. We would like to see some early positive news on any program to gain confidence."
In the meantime, Eckard predicted that the main focus will likely remain on Angiomax litigation with updates on the current appeal trial likely sometime during mid-year. Investors are also closely watching the outcome of the company's re-submission to the U.S. Food and Drug Administration for cardiac drug Cangrelor comes around June, with an AdCom meeting likely before then. MDCO is also expecting FDA decisions in the second quarter for Raplixa (hemostatic powder for use during surgery) and Ionsys (patient controlled analgesic patch, PDUFA on 4/30/15).
Early trial results are expected for MDCO's drugs ALN-PCS (antisense PCSK9) and ABP-700 (rapid on/off general anesthetic) around mid-year with potential to move the needle for the stock.
"We view the upcoming FDA AdCom and approval decision around Cangrelor around June to be important events to set sentiment for the pipeline," said Eckard. "We see improved chances for success this round (with a 50 percent probably of success) due to, one, better sense of FDA concerns and can be better prepared to address the sticking points, two, the retirement of the FDA reviewer that led a highly negative view that drove the rejection last round, and three, the drug has since been approved in the European Union."
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