General and administrative expenses totaled $5.2 million for the three months ended June 30, 2017, compared to $4.3 million for the three months ended June 30, 2016. For the nine months ended June 30, 2017, general and administrative expenses totaled $15.6 million, compared to $12.5 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 compensation expense driven substantially by increased headcount. For the nine 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 June 30, 2017 of $4.1 million compared to an income tax expense of $0.4 million for the same period in 2016. The Company's estimated annual effective tax rate for fiscal 2017 of approximately 33% was slightly below the statutory rate of 35% due to the availability of research and development tax credits. The net loss for the three months ended June 30, 2017 was $8.4 million, or $(0.44) per diluted common share, compared to a net loss of $1.1 million, or $(0.06) per diluted common share, for the corresponding period in 2016. For the nine months ended June 30, 2017, net loss was $18.8 million, or $(0.99) per diluted common share, compared to net income of $23.5 million, or $1.22 per diluted common share, for the corresponding period in 2016. "Enanta continues to make great progress from a research and development perspective," stated Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta. Our second commercialized protease inhibitor product, glecaprevir, is one of the two new DAAs in AbbVie's new pan-genotypic treatment regimen for HCV, which was recently approved in the EU and in the U.S. under the names MAVIRET™ and MAVYRET™, respectively. Additionally, data from the Phase 1 clinical study on our NASH candidate EDP-305 will be available soon, and, with our strong cash resources of over $235 million, we are well funded to continue to advance our clinical programs in NASH, PBC, RSV and HCV."
Development Program and Business Review
- On June 25 at the XIX International Symposium on Respiratory Viral Infections in Berlin, Germany, Enanta presented data on its respiratory syncytial virus inhibitor candidate EDP-938, which demonstrated a greater than 4-log reduction in viral load in an animal model challenged with RSV. Enanta expects to initiate a Phase 1 clinical study with EDP-938 during the fourth quarter of calendar 2017.
- On July 28, the European Commission granted AbbVie marketing authorization for MAVIRET (glecaprevir/pibrentasvir), and on August 3, the U.S. Food and Drug Administration (FDA) granted AbbVie marketing approval for MAVYRET (glecaprevir/pibrentasvir), sometimes referred to as the G/P regimen, AbbVie's new pan-genotypic treatment for patients with chronic hepatitis C virus (HCV) infection. Glecaprevir is Enanta's second protease inhibitor being developed and commercialized by AbbVie and is one of the two new direct-acting antivirals in G/P. Enanta earned a total of $65 million in milestone payments following the EU and U.S. approvals. Enanta is eligible to earn the remaining $15 million milestone payment upon G/P receiving commercial regulatory approval in Japan, which is anticipated next quarter. Additionally, Enanta is eligible to receive annually tiered, double digit, per product royalties on 50% of the net sales of G/P.
- Enanta expects to announce clinical data from its ongoing Phase 1 clinical study of EDP-305 in healthy volunteers and presumed NAFLD subjects 1 at the AASLD meeting in October and is conducting NASH-enabling studies during the second half of this year. A Phase 2 study in PBC is also expected to begin in the next quarter, and a Phase 2 study in NASH is expected to begin in early 2018.
- September 6, 2017 - Baird 2017 Global Healthcare Conference, New York
- September 11-13, 2017 - Morgan Stanley 15 th Annual Global Healthcare Conference, New York
- September 25-27, 2017 - Cantor Fitzgerald Global Healthcare Conference, New York
- Enanta plans to issue its fiscal fourth quarter financial results press release, and hold a conference call regarding those results, on November 20, 2017.
|ENANTA PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three Months Ended||Nine Months Ended|
|June 30,||June 30,|
|Research and development||15,407||10,785||40,937||28,961|
|General and administrative||5,233||4,282||15,631||12,526|
|Total operating expenses||20,640||15,067||56,568||41,487|
|Income (loss) from operations||(13,129)||(1,089)||(29,681)||33,940|
|Other income, net||600||447||1,673||1,248|
|Income (loss) before income taxes||(12,529)||(642)||(28,008)||35,188|
|Income tax (expense) benefit||4,103||(434)||9,210||(11,720)|
|Net income (loss)||$||(8,426)||$||(1,076)||$||(18,798)||$||23,468|
|Net income (loss) per share|
|Weighted average common shares outstanding|
|ENANTA PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||September 30,|
|Cash and cash equivalents||$||22,263||$||16,577|
|Short-term marketable securities||169,752||193,507|
|Prepaid expenses and other current assets||6,589||9,231|
|Total current assets||206,115||232,156|
|Property and equipment, net||8,070||8,004|
|Long-term marketable securities||43,321||32,119|
|Deferred tax assets||17,723||8,390|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||5,634||4,512|
|Total current liabilities||11,122||7,889|
|Series 1 nonconvertible preferred stock||164||159|
|Other long-term liabilities||2,394||2,042|
|Total stockholders' equity||260,866||269,936|
|Total liabilities and stockholders' equity||$||275,837||$||281,277|