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|Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2016|
WATERTOWN, Mass.--(BUSINESS WIRE)--
ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal first quarter ended December 31, 2016.' Enanta Pharmaceuticals, Inc. (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal first quarter ended December 31, 2016.
Enanta's cash, cash equivalents and short-term and long-term marketable securities totaled $244.4 million at December 31, 2016. This compares to a total of $242.4 million in such accounts at September 30, 2016. Enanta expects that its current cash, cash equivalents and marketable securities will be sufficient to meet the anticipated cash requirements of its existing business for the foreseeable future.
Fiscal First Quarter Ended December 31, 2016 Financial Results
Total revenue for the three months ended December 31, 2016 was $10.4 million, compared to $48.4 million for the three months ended December 31, 2015. For the current quarter, revenue consisted exclusively of royalties earned on AbbVie's worldwide net sales of HCV regimens containing paritaprevir. For the 2015 period, revenue primarily consisted of royalty revenue of $17.9 million and a $30.0 million milestone payment for the reimbursement approval of VIEKIRAX® in Japan. Milestone payments and royalties have varied significantly from period to period, and we expect that variability to continue in the future.
Research and development expenses totaled $12.5 million for the three months ended December 31, 2016, compared to $9.0 million for the three months ended December 31, 2015. The increase in research and development expenses was primarily due to increased preclinical and clinical costs associated with the progression of Enanta's wholly-owned R&D programs in non-alcoholic steatohepatitis (NASH)/primary biliary cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B virus (HBV).
General and administrative expenses totaled $4.9 million for the three months ended December 31, 2016, compared to $3.8 million for the three months ended December 31, 2015. The increase in general and administrative expenses was primarily due to increases in stock-based compensation expense driven by increased headcount and achievement of milestones under existing performance-based restricted stock unit awards.
Enanta recorded an income tax benefit for the three months ended December 31, 2016 of $1.5 million compared to income tax expense of $9.7 million for the same period in 2015. The Company's estimated annual effective tax rate for fiscal 2017 of 23.6% was driven by federal research and development tax credits which reduced the Company's annual effective tax rate below the statutory rate of 35.0%. For the three months ended December 31, 2015, the Company's effective tax rate of 27.1% was also driven by federal research and development tax credits.
Net loss for the three months ended December 31, 2016 was $5.0 million, or $(0.26) per diluted common share, compared to net income of $26.2 million, or $1.36 per diluted common share, for the corresponding period in 2015.
"With the NDA for glecaprevir/pibrentasvir, or G/P, now having been granted priority review in the U.S. and the MAA for G/P validated with accelerated assessment in the EU, we expect to earn a substantial portion of the $80 million in commercialization regulatory approval milestone payments for G/P in calendar 2017," commented Jay R. Luly, Ph.D., President and Chief Executive Officer. "This collaboration, along with our existing financial resources, is providing funding for our advancing pipeline. We expect to complete our Phase 1 study of EDP-305 mid-year and later this year plan to initiate a Phase 2 study of EDP-305 in PBC. We also plan the initiation of clinical development of our lead RSV compound, EDP-938 in calendar 2017."
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Enanta has discovered novel protease inhibitors for use against the hepatitis C virus (HCV). These protease inhibitors, developed through Enanta's collaboration with AbbVie, include paritaprevir, currently marketed in AbbVie's HCV regimens, and glecaprevir (ABT-493), Enanta's second protease inhibitor product, which AbbVie is developing as part of its investigational HCV regimen of glecaprevir/pibrentasvir (G/P) now in registration in the U.S. and the E.U. Royalties and any further milestone payments from this collaboration will provide funding for Enanta's earlier development programs, including its Phase 1 FXR agonist program for NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com for more information on Enanta's programs and pipeline.
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