The Medicines Company (MDCO) reported a first-quarter profit of 60 cents per share, including the impact of stock-based compensation expense. First quarter profit was well above the Zacks Consensus Estimate of 39 cents and the year-ago profit of 19 cents.
Performance was boosted by higher revenues. Revenues, up 9.8% at $112.1 million, surpassed the Zacks Consensus Estimate of $110 million.
The Quarter in Detail
Angiomax US sales increased 9.7% to $105 million during the first quarter. During the fourth quarter, the company had reported extra stocking in hospitals ahead of a price increase for Angiomax in January 2011.
The company estimates that about 80% of that buy-in was used during the first quarter with the remaining 20% expected to be used through the rest of the year. Ex-US sales increased 26.9% to $7.1 million.
The Medicines Company is working on driving growth in ex-US markets by promoting data on the product. Moreover, Angiox (Angiomax’ trade name in Europe) has Class I recommendation from the European Society of Cardiology for heart attack patients undergoing percutaneous coronary intervention (PCI).
While approval for Angiomax in India is expected later this year, The Medicines Company will commence a confirmatory study in China soon. Meanwhile, Angiomax could be launched in Brazil in 2012.
Angiomax, acquired from Biogen Idec Inc. (BIIB), is the lead product at The Medicines Company. Acquired in 1996, Angiomax is used as an anticoagulant in patients undergoing coronary angioplasty.
Meanwhile, Cleviprex (clevidipine) is the only other drug at The Medicines Company that received FDA approval in 2008. The company had initiated a voluntary recall of Cleviprex in December 2009 due to the presence of visible particulate matter in some vials.
The Medicines Company started shipping Cleviprex to customers two weeks back. The full re-launch is scheduled to take place in the second half of 2011. Going forward, The Medicines Company intends to focus on neuro critical care and surgical procedures in the cardiac area where blood pressure control is very critical.
R&D spend increased 40.9% to $23.8 million mainly due to ongoing phase III studies with two candidates — Cangrelor and oritavancin. SG&A expenses declined 17.8% to $37.9 million.
Backs Guidance
The Medicines Company maintained its guidance for 2011. The company expects revenues to grow 6-9% in 2011. While R&D spend is expected to be up to 20% of revenues, SG&A spend is expected to be flat to slightly above 2010 levels.
Pipeline Update
The Medicines Company also provided an update on its pipeline candidates. The company said that patient enrolment for its new phase III study (Champion Phoenix) with Cangrelor has accelerated. Results should be available in 2012.
Meanwhile, The Medicines Company is hoping to gain approval for the ready-to-use formulation of Argatroban later this year. The Medicines Company said that it has started enrolling patients in a phase III program, SOLO, of oritavancin for the treatment of acute bacterial skin and skin structure infections (ABSSI). Results will be out in 2012. Positive results would allow The Medicines Company to file for US approval in 2012.
The Medicines Company’s early-stage candidates include MDCO-216 and MDCO-2010. The company acquired worldwide rights to MDCO-216 from Pfizer (PFE). MDCO-216 is a naturally occurring variant of a protein that could be used to reverse the development of arterial plaque development and reduce the risk of heart problems in patients with acute coronary syndrome (ACS).
If developed successfully, MDCO-216 should fit well within The Medicines Company’s product portfolio. Phase I studies with the candidate are scheduled to commence in 2011.
MDCO-2010, which became a part of The Medicines Company’s portfolio through its acquisition of Curacyte, is a small molecule serine protease inhibitor. Phase II data on the candidate should be out in 2011. The company completed a phase Ib study and expects to commence additional studies during the third quarter of 2011.
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