Investors reacted positively to The Medicines Company’s (MDCO) third quarter results with shares increasing more than 9% since the company announced results on Oct 23 before the opening bell. The company’s third quarter earnings of 47 cents per share were well above the year-ago earnings of 27 cents per share. Including the impact of stock-based compensation expense, third quarter 2013 earnings were 38 cents per share, significantly above the year-ago earnings of 22 cents per share. The Zacks Consensus Estimate for the third quarter of 2013 was 19 cents per share.
Including one-time items, the company reported earnings of 12 cents per share compared to the year-ago earnings of 17 cents per share. Third quarter 2013 revenues increased 27% year over year to $174.3 million, ahead of the Zacks Consensus Estimate of $173 million.
The Quarter in Detail
Angiomax U.S. sales increased 12% to $138.5 million due to higher volume (7.3%) and price increases (4.6%). Ex-U.S. sales of Angiomax increased 52% to $15.1 million during the quarter. The Medicines Co. reported continued growth in market share in the percutaneous coronary intervention (PCI) segment in the U.S.
The Medicines Co. is currently working on expanding Angiomax’ label into peripheral endovascular intervention (PEI). The company is conducting a phase III study (ENDOMAX - ENDOvascular interventions with AngioMAX) in patients undergoing PEI.
Recothrom sales in the U.S. were $17 million, reflecting volume growth of 10.7%. The Medicines Co. started selling Recothrom from Feb 8, 2013 under its collaboration with Bristol-Myers Squibb (BMY). Net sales of The Medicines Co.’s Ready-to-Use (:RTU) Argatroban, Cleviprex and generic portfolio increased 22% to $3.7 million in the third quarter of 2013. The Medicines Co. intends to launch Cleviprex in Europe early next year.
The Medicines Co. maintained its 2013 net revenue growth guidance of 20% - 22%.
Meanwhile, The Medicines Co. has made significant progress with its pipeline. While its antiplatelet candidate, Cangrelor, is currently under FDA review (for use in patients undergoing PCI and in patients requiring bridging from oral antiplatelet therapy to surgery), the company intends to file a new drug application (:NDA) for its antibiotic candidate, oritavancin, by year end.
As far as Cangrelor is concerned, a response from the FDA should be out in the second quarter of 2014. The company intends to file for EU approval shortly.
Meanwhile, a regulatory submission for Fibrocaps (a dry powder topical fibrinogen thrombin hemostat) will be filed in the EU by year end. The U.S. filing is slated for the first quarter of 2014. A supplemental new drug application (sNDA) for Ionsys (a patient-controlled analgesia system for the management of acute postoperative pain) will be submitted early next year in the U.S. and in the third quarter of 2014 in the EU.
We are impressed by The Medicines Co.’s progress with its pipeline. With Cangrelor under FDA review and oritavancin scheduled to be filed this year, The Medicines Co. could potentially have two additional products in its portfolio next year.
The Medicines Co. currently carries a Zacks Rank #3 (Hold). Currently, companies like Actelion Ltd. (ALIOF) and Isis Pharmaceuticals (ISIS) look well-positioned with both being Zacks Rank #1 (Strong Buy) stocks.