“The current annualized run rates, based on dollarizing the August 2012 prescription data for XIFAXAN, MOVIPREP/OSMOPREP, APRISO, RELISTOR (U.S.) and our ’other products’, are approximately $495 million, $108 million, $87 million, $32 million, and $48 million, respectively. In line with the full year 2012 guidance provided above, for the fourth quarter of 2012 we anticipate total Company product revenue should be approximately $198 million and adjusted net income should be approximately $46 million, or $0.72 per share, fully diluted, on the non-GAAP basis described above.”
Carolyn Logan, President and Chief Executive Officer, stated, “Our third quarter growth was driven primarily by XIFAXAN 550, APRISO and RELISTOR. XIFAXAN continues to grow sequentially, with prescriptions, on a milligram basis, increasing 5% for the third quarter of 2012 compared to the second quarter of 2012. APRISO also continued to exceed the Company’s expectations during the quarter. APRISO prescriptions increased 4% during the third quarter of 2012 compared to the second quarter of 2012. RELISTOR prescriptions increased 18% during the third quarter of 2012 compared to the second quarter of 2012.
“During the third quarter our sales force continued launching SOLESTA
- our first-in-class, biocompatible tissue bulking agent for the treatment of fecal incontinence, or FI. Fecal incontinence is estimated to affect approximately 15% of people in the United States over the age of 50 and is the leading reason for admission to assisted living facilities in the United States. Physicians and patients have shown significant interest in the use of SOLESTA as an alternative to more invasive treatment options in the treatment of FI. In early November the Centers for Medicare and Medicaid Services (CMS) assigned SOLESTA a unique HCPCS code of “L8605” for reimbursement purposes. This new code will facilitate separate reimbursement for SOLESTA across multiple settings of care. SOLESTA will be billed under the new code L8605 (Injectable Bulking Agent, Anal Canal) effective January 1, 2013.
“On July 27, 2012 the Company received from the FDA a Complete Response Letter (CRL) requesting additional clinical data for our supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. On October 5, 2012 Salix conducted an End-of-Review meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products to better understand the contents of the letter. The Division has expressed a concern that there may be a risk associated with the chronic use of mu-opioid antagonists in patients that are taking opioids for chronic pain. In order to understand this potential risk, the Division has communicated that a very large, well-controlled, chronic administration trial will have to be conducted to assess the safety of any mu-opioid antagonist prior to market approval for the treatment of patients with OIC who are taking opioids for chronic, non-cancer pain. Salix has held discussions with the Division and has expressed the view that the post-marketing, clinical and preclinical data currently available for RELISTOR adequately demonstrate an appropriate and expected safety profile sufficient to permit the approval of the current sNDA.