General and administrative expenses totaled $5.5 million for the three months ended March 31, 2017, compared to $4.4 million for the three months ended March 31, 2016. For the six months ended March 31, 2017, general and administrative expenses was $10.4 million, compared to $8.2 million for the same period in 2016. For the three month period, the increase in general and administrative expenses was primarily due to increases in stock-based compensation expense driven by increased headcount. For the six month period, the increase was due to increased headcount as well as achievement of milestones under existing performance-based stock awards.Enanta recorded an income tax benefit for the three months ended March 31, 2017 of $3.6 million compared to an income tax expense of $1.6 million for the same period in 2016. The Company's estimated annual effective tax rate for fiscal 2017 of 33.0 percent was slightly below the statutory rate of 35.0 percent due to the availability of federal research and development tax credits. Net loss for the three months ended March 31, 2017 was $5.4 million, or $(0.28) per diluted common share, compared to net loss of $1.6 million, or ($0.09) per diluted common share, for the corresponding period in 2016. For the six months ended March 31, 2017, net loss was $10.4 million, or ($0.54) per diluted common share, compared to net income of $24.5 million, or $1.28 million per diluted common share, for the corresponding period in 2016. "With our second partnered protease inhibitor product, glecaprevir, expected to launch starting in August as part of AbbVie's new, investigational G/P treatment for HCV, the prospects for additional milestone and royalty payments to us for G/P are significant," stated Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. "Any such payments, coupled with our existing financial resources, will allow us to advance our clinical program in NASH/PBC and also fund our additional R&D programs, including our lead compound EDP-938 for RSV, scheduled to begin clinical development later this year."
Development Program and Business Review
- Enanta presented new preclinical data on EDP-305, its wholly-owned FXR agonist for non-alcoholic steatohepatitis, at the International Liver Congress™ (ILC) 2017 in Amsterdam. Data from three poster presentations presented at the Congress demonstrated that EDP-305 is a potent Farnesoid X receptor (FXR) agonist that has been shown to reduce expression of fibrogenic genes, reduce fibrosis progression and improve non-alcoholic fatty liver disease (NAFLD) activity scores (NAS) in a variety of preclinical models.
- Enanta expects to present clinical data from our ongoing Phase 1 clinical study of EDP-305 in healthy volunteers and presumed NAFLD subjects 1 and to initiate NASH-enabling studies in the second half of this year. A Phase 2 study in PBC is expected to begin in the fourth quarter of calendar 2017 and Phase 2 studies in NASH are expected to begin in early 2018.
- Also at the ILC, AbbVie presented new data from its investigational, pan-genotypic, ribavirin-free regimen for hepatitis C virus (HCV) consisting of a combination of glecaprevir/pibrentasvir (G/P). Data from the EXPEDITION-1 study demonstrated that 99 percent (n=145/146) of chronic HCV infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR 12) with G/P. This high SVR 12 rate was seen following 12 weeks of G/P treatment without ribavirin. Data were also presented at the ILC from the ENDURANCE-3 study. In this study, 95 percent (n=149/157) of genotype 3 (GT3) chronic HCV-infected patients without cirrhosis and who were new to treatment, achieved sustained virologic response at 12 weeks post-treatment (SVR 12) following 8 weeks of treatment with G/P.
- In March, Enanta announced the Japanese Ministry of Health, Labour and Welfare (MHLW) granted priority review designation to AbbVie's G/P combination for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV) infection. AbbVie had submitted the NDA for the G/P regimen in Japan in February 2017. The NDAs for G/P in the U.S and Japan have been granted priority review designation, and the MAA for G/P has been granted accelerated assessment in the E.U.
- On June 25 at the XIX International Symposium on Respiratory Viral Infections in Berlin, Germany, Enanta will present data on EDP-938, its respiratory syncytial virus inhibitor candidate in an oral presentation titled: " EDP-938, a Novel Non-Fusion Replication Inhibitor of Respiratory Syncytial Virus, Demonstrates Potent Antiviral Activities both In Vitro and In Vivo".
- Enanta plans to issue its fiscal third quarter financial results press release, and hold a conference call regarding those results, on August 7, 2017.
|ENANTA PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|March 31,||March 31,|
|Research and Development||13,004||9,143||25,530||18,176|
|General and administrative||5,461||4,426||10,398||8,244|
|Total operating expenses||18,465||13,569||35,928||26,420|
|Income (loss) from operations||(9,506||)||(565||)||(16,552||)||35,029|
|Other income, net||549||472||1,073||801|
|Income (loss) before income taxes||(8,957||)||(93||)||(15,479||)||35,830|
|Income tax (expense) benefit||3,565||(1,552||)||5,107||(11,286||)|
|Net income (loss)||$||(5,392||)||$||(1,645||)||$||(10,372||)||$||24,544|
|Net income (loss) per share|
|Weighted average common shares outstanding|
|ENANTA PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||September 30,|
|Cash and cash equivalents||$||19,211||$||16,577|
|Short-term marketable securities||156,362||193,507|
|Prepaid expenses and other current assets||6,059||9,231|
|Total current assets||190,591||232,156|
|Property and equipment, net||8,526||8,004|
|Long-term marketable securities||65,330||32,119|
|Deferred tax assets||13,903||8,390|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||5,098||4,512|
|Total current liabilities||9,154||7,889|
|Series 1 nonconvertible preferred stock||162||159|
|Other long-term liabilities||2,355||2,042|
|Total stockholders' equity||266,011||269,936|
|Total liabilities and stockholders' equity||$||278,958||$||281,277|