Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced unaudited fourth quarter and full-year 2012 revenues and provided business updates, including the expected timing of data readouts for two ongoing Phase 3 clinical trials of CXA-201 (ceftolozane/tazobactam). Cubist continued to deliver double-digit total revenue growth in the fourth quarter. Fourth quarter and year-end 2012 unaudited revenue results include:
- Total net revenues for Q4 2012 of $245.9 million were up 16% compared to Q4 of 2011. Full-year 2012 total net revenues were $926.4 million, up 23% compared to $754.0 million in 2011.
- U.S. CUBICIN® (daptomycin for injection) net product revenues in Q4 2012 increased 14% to $216.0 million from $190.1 million in Q4 2011. Full-year 2012 total U.S. CUBICIN net product revenues were $809.2 million, up 16% compared to $698.8 million in 2011.
- International CUBICIN revenues for Q4 2012 increased 34% to $14.5 million from $10.8 million in Q4 2011. Full-year 2012 total international CUBICIN revenues were $50.5 million, up 38% compared to $36.7 million in 2011.
- ENTEREG® (alvimopan) net product revenues were $10.9 million in the fourth quarter of 2012. Full-year 2012 total ENTEREG net product revenues were $40.2 million.
- Service revenues for DIFICID® (fidaxomicin) in the fourth quarter of 2012 were $3.7 million. Full-year 2012 total services revenues for DIFICID were $23.2 million.
- The updated timing for anticipated top-line data from ceftolozane/tazobactam’s Phase 3 studies in cUTI and cIAI;
- CB-315’s recent QIDP designation, and Phase 3 trials now underway in Clostridium difficile-associated diarrhea (CDAD); and
- The bevenopran (CB-5945) Phase 3 program to develop a potential therapy for patients with opioid-induced constipation (OIC) which began in October 2012 with the initiation of a large, well-controlled, long-term safety trial. Three Phase 3 efficacy trials are planned to begin in the first half of 2013.
|******************Q4 2012 CONFERENCE CALL & WEBCAST INFORMATION******************Cubist will host a conference call and live audio webcast to discuss both its fourth quarter andfull-year 2012 financial results, business activities and financial outlook.WHEN: Wednesday, January 23, 2013 at 5:00 p.m. ETLIVE DOMESTIC & CANADA CALL-IN: (855) 319-7654LIVE INTERNATIONAL CALL-IN: (484) 756-4327Attendee Passcode: 8398635724-HOUR REPLAY DOMESTIC & CANADA: (855) 859-205624-HOUR REPLAY INTERNATIONAL: (404) 537-3406REPLAY PASSCODE:Conference ID: 83986357CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:www.cubist.comReplay will be available for 90 days via the Internet at www.cubist.com**********************************************************************|
About CubistCubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubist’s web site at www.cubist.com. Cubist Safe Harbor Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding (i) our unaudited expected fourth quarter and full-year 2012 financial results, (ii) the expected timing of data readouts for our two ongoing Phase 3 clinical trials of CXA-201, (iii) the expected timing of our NDA for ceftolozane/tazobactum in cUTI and cIAI, (iv) the expected five-year extension of Hatch-Waxman exclusivity for ceftolozane/tazobactum, (v) our belief in the blockbuster potential of ceftolozane/tazobactum, (vi) the expected timing of beginning Phase 3 efficacy trials for CB-5945 and (vii) our plan to execute against our Building Blocks of Growth five-year goals, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include: the risk that our final fourth quarter and 2012 full-year audited financial results will differ materially from our expected results disclosed in this release; our ability to continue to grow revenues from the sale of CUBICIN, the ability of our third-party suppliers to produce and deliver adequate amounts of CUBICIN; competition from generic drug companies such as Teva and Hospira; our ability to successfully market and sell ENTEREG, our ability to successfully develop, gain marketing approval for and commercially launch ceftolozane/tazobactam and our other product candidates for their planned indications and on the timelines that we expect; our ability to in-license or acquire new products and product candidates; our ability to achieve and manage our growth in our business; and those additional factors discussed in our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and we undertake no obligation to update or revise any of these statements.