[Cash at 13/31/13 was $106.2M, implying a cash burn during FY1Q14 of $6.0M. Inasmuch as ENTA expects $195M of milestone payments from ABBV during the next year merely to get regulatory approval for ABBV/ENTA’s 3-DAA HCV regimen in the US and EU, liquidity is clearly not an issue. Note: There is no quarterly CC because ENTA is presenting at the Leerink conference today at 2:15pm ET.]
›Fiscal First Quarter Ended December 31, 2013 Financial Results
Revenue for the three months ended December 31, 2013 was $0.9 million compared to $27.9 million for the three months ended December 31, 2012. The changes in revenue for the three-month periods are primarily related to the timing and amount of milestone and other payments from collaborations, which have varied significantly from period to period and are expected to continue to do so.
Research and development expenses totaled $4.3 million for the three months ended December 31, 2013 compared to $4.8 million for the three months ended December 31, 2012. The decrease is primarily due to a decrease in preclinical spending.
General and administrative expenses totaled $2.1 million for the three months ended December 31, 2013 compared to $1.2 million for the three months ended December 31, 2012. The increase is primarily due to additional expenses incurred as a result of operating as a public company.
Net loss for the three months ended December 31, 2013 was $5.4 million compared to a net income of $22.0 million for the same period in 2012.
Cash, cash equivalents and marketable securities totaled $106.2 million at December 31, 2013. This compares to $112.2 million at September 30, 2013. Enanta expects that its current cash, cash equivalents and marketable securities will be sufficient to meet its anticipated cash requirements for at least the next 24 months.
“Enanta is beginning 2014 with a strong cash position and four compounds in the clinic,” stated Jay R. Luly, Ph.D., President and Chief Executive Officer. “Our partner AbbVie recently completed the largest phase 3 program to date for an all-oral, genotype 1 hepatitis C virus treatment regimen, and it expects to launch the regimen in 2014. AbbVie’s tested regimen includes our collaboration’s lead protease compound ABT-450. In addition, we continue to explore new infectious disease areas and have recently initiated a phase 1 study of our proprietary bicyclolide candidate EDP-788 which we are developing for MRSA.”
Pipeline and Business Review
• Topline data from all six of the phase 3 hepatitis C virus registration studies for the ABT-450 containing regimen have now been released demonstrating sustained virologic response rates 12 weeks post treatment (SVR12) in genotype 1 (GT1) subtypes, including 92 to 96 percent in cirrhotic patients
• Timothy D. Ocain, Ph.D. was appointed Senior Vice President, New Product Strategy and Development
• Enrollment has begun in two phase 3 studies in Japan, GIFT-I and GIFT II, for GT1 and GT2 HCV patients respectively
• A phase 1 study of methicillin-resistant Staphylococcus aureus (MRSA) infection candidate Bicyclolide EDP-788 was initiated
• Bruce L.A. Carter, Ph.D. and George S. Golumbeski, Ph.D. were appointed to Enanta’s Board of Directors‹
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