Vertex Pharmaceuticals Incorporated reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the period, the company reported net loss of $312,627,000 and net loss attributable to the company was $308,016,000 or $1.43 per basic and diluted share on total revenue of $328,368,000 against net income of $87,876,000 and net income attributable to the company was $91,590,000 or $0.44 per basic share and $0.43 per diluted share on total revenue of $438,737,000 a year ago. Loss from operations was $438,288,000 compared to income from operations was $91,649,000 a year ago. Loss before provision for income taxes was $442,940,000 compared to income before benefit from income taxes was $87,908,000 a year ago. On Non-GAAP basis, income from operations was $11,092,000, income before benefit from income taxes was $6,448,000, net income and net income attributable to the company was $5,749,000 or $0.03 per diluted share against income from operations was $124,722,000, income before benefit from income taxes was $120,919,000, net income and net income attributable to the company was $118,607,000 or $0.55 per diluted share a year ago. The company announced intangible asset impairment charge was $412,900,000 for the first quarter ended March 3, 2013. The company updated its financial guidance for full-year 2013 KALYDECO net revenues. The company now expects full-year 2013 KALYDECO net revenues to be in the range of $300 million to $340 million. The prior range, provided on January 29, 2013, was for full-year 2013 KALYDECO net revenues to be in the range of $280 million to $320 million. The company reiterated its financial guidance for total 2013 revenues to be in the range of $1.10 billion to $1.25 billion. The company also reiterated its guidance for total 2013 non-GAAP operating expenses, excluding cost of revenues, stock-based compensation expense, intangible asset impairment charges and Alios expenses related to the accounting for the collaboration with the company, of $1.09 billion to $1.15 billion, including full-year 2013.

Vertex Pharmaceuticals Incorporated has announced new data from a viral kinetic study of the uridine nucleotide analogue ALS-2200 (VX-135) in development for the treatment of hepatitis C. There was a median 4.08 log10 reduction in hepatitis C virus (HCV) RNA after seven days of dosing with 200 mg once daily in treatment-naive people with genotype 1 chronic HCV infection and compensated cirrhosis. Among treatment-naive people with genotypes 3 or 4 chronic HCV infection, there was a median 4.65 log10 reduction in HCV RNA after seven days of dosing with 200 mg once daily. Prior to a protocol amendment, one treatment-naive person with genotype 2 HCV infection received 100 mg of ALS-2200 once daily for seven days, and had a 5.04 log10 reduction in HCV RNA after seven days of dosing. ALS-2200 was well-tolerated in this study, there were no serious adverse events and no patients discontinued due to adverse events. These new data are consistent with previously reported data in people with genotype 1 chronic HCV infection, and will be presented the 48th Annual Meeting of the European Association for the Study of the Liver (EASL) in Amsterdam, Netherlands, April 24 to 28, (poster #866). These data support Vertex's recently announced non-exclusive agreement with Bristol-Myers Squibb Company to conduct Phase 2 studies of once-daily all-oral treatment regimens containing VX-135 and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C. As part of the agreement, Vertex plans to conduct two Phase 2 studies of the combination, including an initial study in treatment-naive people with genotype 1 HCV infection planned for the second quarter of 2013. Vertex plans to begin a subsequent study in treatment-naive people infected with genotype 1, 2 or 3 HCV, including those with cirrhosis, in the second half of 2013, pending data from the initial study.

Vertex Pharmaceuticals Incorporated announced new data from an interim analysis of the exploratory global Phase 3b CONCISE study evaluating the potential to shorten total treatment with telaprevir combination therapy to 12 weeks in certain people with genotype 1 chronic hepatitis C virus (HCV) infection who have the IL28B CC genotype. In the CONCISE trial, telaprevir was administered twice daily in combination with pegylated-interferon and ribavirin. Of the 239 people in the study, 159 people completed 12 weeks of telaprevir combination treatment and had undetectable hepatitis C virus at week four of treatment (rapid viral response, or RVR) and were eligible to be randomized. One hundred seven people were randomized to receive no further treatment and 52 people were randomized to receive an additional 12 weeks of treatment with pegylated-interferon and ribavirin alone, for a total of 24 weeks of treatment. In the 12-week total treatment group, of the 85 people with data available at the time of the interim analysis, 87% (74/85) had undetectable hepatitis C virus 12 weeks after the end of treatment (SVR12). In the 24-week treatment group, of the 30 people with data available at the time of the interim analysis, 97% (29/30) achieved SVR12. This study includes people with genotype 1 chronic HCV who were new to treatment or who had relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. Approximately one-third of people with hepatitis C have the 'CC' genotype, which has been associated with higher sustained viral response (SVR, or viral cure) rates and faster response to interferon-based treatment. The safety profile of telaprevir combination therapy observed in the CONCISE study through the time of the interim analysis was similar to that seen in previously reported clinical trials. The interim results of this study will be presented at the 48th Annual Meeting of the European Association for the Study of the Liver (EASL) in Amsterdam, Netherlands, April 24 to 28, 2013 (poster #881). Telaprevir is approved for use in combination with pegylated-interferon and ribavirin by the U.S. Food and Drug Administration (FDA) and Health Canada under the brand name INCIVEK(R) (telaprevir) tablets for people with genotype 1 chronic HCV infection with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK's approved dosing schedule is two 375mg tablets three times daily, and it is given for 12 weeks in combination with pegylated-interferon and ribavirin. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks.