Shares of Cubist Pharmaceuticals, Inc. ( CBST ) have been on the rise following upbeat preliminary sales results for the fourth quarter of 2013. The biopharmaceutical company will release detailed fourth quarter and full year 2013 results on Jan 23, 2014 after the closing bell.
As per the preliminary results, Cubist Pharma expects fourth quarter 2013 revenues of $299.7 million, up 22%. Fourth quarter sales are above the current Zacks Consensus Estimate of $281 million. The strong results were driven by impressive sales of Cubist Pharma's key growth engine, Cubicin (daptomycin), an antibiotic injection. The preliminary results hinted at a 15% year-over-year growth in Cubicin sales to $248.9 million.
For full year 2013, total revenues climbed 14% to $1.1 billion. According to the preliminary data, Cubicin, accounting for the bulk of revenues, recorded global sales of more than $1 billion. Cubicin performed very well in the U.S. with sales climbing 12% to $908 million in 2013.
Cubist Pharma strengthened its antibiotics portfolio further by acquiring two antibiotic makers, Optimer Pharma and Trius Therapeutics. The acquisition of Trius added tedizolid phosphate (TR-701) to Cubist Pharma's pipeline. The candidate is under priority review in the U.S. for treating acute bacterial skin and skin structure infections (ABSSSI). A final decision from the U.S. Food and Drug Administration (FDA) is expected on Jun 20, 2014. European approval of the candidate for the same indication is expected to be sought by Jun 30, 2014. Following the acquisition of Optimer, Cubist Pharma has gained full control of Dificid (Clostridium difficile-associated diarrhea or CDAD. The company intends to re launch the drug in 2014. Dificid is also being studied for preventing CDAD in patients undergoing hematopoietic stem cell transplant (phase IIIb). Another CDAD candidate in Cubist Pharma's pipeline is surotomycin (phase III). The top-line data is expected in 2015. Approval in the U.S. and EU is expected to be sought later compared to the earlier projection of the second half of 2015.
Ceftolozane/tazobactam is another interesting candidate in Cubist Pharma's pipeline. The impressive top-line data on ceftolozane/tazobactam from the phase III studies in the complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) indications is encouraging. On the back of positive results from these two phase III studies, the company intends to submit a New Drug Application (NDA) for ceftolozane/tazobactam to the FDA in the first half of 2014 for both indications. Cubist Pharma also intends to do the same in the EU in the latter half of the year. Approval of ceftolozane/tazobactam will drive the company's long-term growth. Furthermore, Cubist Pharma intends to initiate a phase III study on ceftolozane/tazobactam in patients suffering from in hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) by Jun 30, 2014.
Cubist Pharma further said that it has decided to suspend the phase III efficacy studies on another pipeline candidate bevenopran in patients suffering from opioid-induced constipation (OIC). The biopharmaceutical company intends to focus on completing the long-term safety study on the candidate. The results of the safety study coupled with the outcome of the Mar 2014 FDA advisory committee meeting on the potential for elevated cardiovascular events related to mu-opioid antagonists like bevenopran are expected to decide Cubist Pharma's action plan regarding the candidate.
We expect investor focus to remain on Cubist Pharma's pipeline going forward. Cubist Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Medivation, Inc. ( MDVN ), Actelion Ltd. ( ALIOF )and Gentium ( GENT ). All these stocks carry a Zacks Rank # 1 (Strong Buy).
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