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Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year Ended September 30, 2015Enanta Pharmaceuticals, Inc., (NASDAQ: 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 fourth quarter and year ended September 30, 2015.
Fiscal Fourth Quarter and Year Ended September 30, 2015 Financial
Results Revenue for the three months ended September 30, 2015 was $14.4 million, compared to $2.6 million for the three months ended September 30, 2014. For the 2015 quarter, revenue consisted primarily of royalties earned on contractually specified portions of AbbVie's worldwide net sales of hepatitis C virus (HCV) treatment regimens containing paritaprevir, Enanta's lead protease inhibitor identified within the ongoing AbbVie-Enanta collaboration. Quarterly royalty revenues are all included in accounts receivable at quarter end and then collected in a single payment in the following quarter. For the twelve months ended September 30, 2015, revenue was $160.9 million, compared to revenue of $47.7 million for the same period in 2014. The increase in revenue for the twelve months ended September 30, 2015 was due primarily to a total of $125 million in payments earned from AbbVie for the achievement of U.S. and EU commercialization regulatory approvals of VIEKIRA PAK™ and VIEKIRAX®, respectively, as well as to royalties earned on those products, compared to $40 million in milestone payments and other contractual revenue in the comparable period in 2014. Milestone payments, royalties and other payments from collaborations have varied significantly from period to period, and are expected to continue to do so. Research and development expenses totaled $7.0 million for the three months ended September 30, 2015, compared to $5.2 million for the three months ended September 30, 2014. For the twelve months ended September 30, 2015, research and development expenses were $23.2 million, compared to $18.7 million for the comparable period in 2014. The increases in the three and twelve month periods over the prior year periods were primarily due to increased internal and external spend on Enanta's proprietary research programs. General and administrative expenses totaled $3.7 million for the three months ended September 30, 2015, compared to $2.8 million for the three months ended September 30, 2014. For the twelve months ended September 30, 2015, general and administrative expenses totaled $13.5 million, compared to $10.0 million for the comparable period in 2014. The increases in the three and twelve month periods primarily reflected increases in stock-based compensation expense, due principally to increases in Enanta's stock price, as well as additional expenses incurred as Enanta expands its operations. Net income for the three months ended September 30, 2015 was $5.8 million, or $0.29 per diluted common share, compared to a net loss of $5.0 million, or ($0.27) per diluted common share, for the corresponding period in 2014. For the twelve months ended September 30, 2015, net income was $79.0 million, or $4.09 per diluted common share, compared to $34.4 million, or $1.80 per diluted common share for the comparable period in 2014. The increase in net income during the twelve month ended September 30, 2015 was primarily due to $125 million in milestone payments received, as well as royalty revenue earned from AbbVie. Net income in the 2014 year reflected a total of $40 million in milestone payments for regulatory filings, and the reversal of the entire valuation allowance related to Enanta's deferred tax assets, which resulted in an income tax benefit of $15.2 million in 2014. "We ended our fiscal year in a position of financial strength and poised for advances in our research pipeline," commented Jay R. Luly, Ph.D., President and Chief Executive Officer. "Our cash and marketable securities balance is strong, and we have royalties on paritaprevir that were running at an annualized rate of approximately $57 million at the quarter ending September 30. Additionally, our second protease inhibitor, ABT-493 has advanced into Phase 3 trials as part of AbbVie's next-generation, fixed-dose combination treatment for HCV, we plan to advance two of our wholly-owned programs - our cyclophilin inhibitor for HCV and an FXR agonist for NASH - into the clinic next year, and we are also advancing other discovery programs." Development Program and Business Review
Financial Guidance
Upcoming Events and Presentations
Conference Call and Webcast Information Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 6:30 p.m. Eastern time on November 23, 2015, through 11:59 p.m. Eastern time on November 30, 2015 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for international callers. The passcode for both the live call and the replay is 58326369. A live audio webcast of the call and replay can be accessed by visiting the "Calendar of Events" section on the "Investors" page of Enanta's website at www.enanta.com. About Enanta Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases. Enanta has developed novel protease and NS5A inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). Enanta's protease inhibitors partnered with AbbVie include paritaprevir, which is contained in AbbVie's marketed DAA regimens for HCV, and ABT-493, Enanta's next-generation protease inhibitor which recently initiated phase 3 development in combination with ABT-530, AbbVie's next-generation NS5A inhibitor. Enanta also has discovered a host-targeted antiviral (HTA) inhibitor for HCV targeted against cyclophilin, which Enanta plans to study in a phase 1 clinical trial in the first quarter of 2016 as well as another DAA program to develop nucleotide polymerase inhibitors. In addition, Enanta has a preclinical program in non-alcoholic steatohepatitis, or NASH, which is a condition that results in liver inflammation and liver damage caused by a buildup of fat in the liver. Forward Looking Statements Disclaimer This press release contains forward-looking statements, including statements with respect to the prospects for royalties on sales of AbbVie's HCV treatment regimens containing paritaprevir, the prospects for AbbVie's development of a next-generation regimen containing ABT-493, the prospects for advancement of the NASH development program, expectations for a commercialization regulatory approval in Japan milestone payment from AbbVie, the prospects for Enanta's cyclophilin inhibitor being valuable in treating resistance forms of HCV, the prospects for advancing a cyclophilin inhibitor for the treatment of HCV and an FXR agonist for the treatment of NASH into clinical trials, and the projected sufficiency of Enanta's cash-equivalent resources and marketable securities. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta's revenues are dependent upon the success of AbbVie's planned regulatory approval and commercialization efforts for its treatment regimens containing paritaprevir; Enanta's longer term revenues will likely be dependent upon the success of AbbVie's planned clinical development and commercialization of next-generation regimens containing ABT-493; regulatory actions affecting any approval of a treatment regimen containing ABT-493; the pricing, market acceptance and reimbursement rates of treatment regimens containing paritaprevir or ABT-493 compared to competitive HCV products on the market and product candidates of other companies under development; the discovery and development risks of early stage discovery efforts in new disease areas; potential competition from the development efforts of others in those new disease areas; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year ended September 30, 2014 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
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