Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2015
Conference Call and Webcast Today at
- Cash and marketable securities totaled
$212 millionat June 30, 2015
- Existing financial resources and anticipated cash flows to fund continued operations and advance proprietary pipeline
Fiscal Third Quarter Ended
Cash, cash equivalents and short-term and long-term marketable securities totaled
Revenue for the three months ended
Research and development expenses totaled
General and administrative expenses totaled
Net income for the three months ended
“Enanta has a solid financial base from milestone payments received and royalty revenues being earned on AbbVie’s net sales of paritaprevir,” commented
Development Program and Business Review
The U.S. Food and Drug Administrationgranted marketing approval on July 24, 2015for TECHNIVIE™, the first and only all oral, interferon-free, two-direct-acting antiviral treatment regimen for Genotype 4 HCV patients. AbbVieannounced interim phase 2b SVR12 results of 100 percent in a study of ABT-493, Enanta’s next-generation HCV protease inhibitor in combination with ABT-530, AbbVie’s next-generation NS5A inhibitor.
- In June,
Nathalie Adda, MD, was appointed as Senior Vice President and Chief Medical Officer of Enanta. AbbViereported results from the TURQUOISE-III study in treatment-naïve and treatment-experienced patients with GT1b chronic HCV with compensated liver cirrhosis. These data demonstrated 100 percent SVR12 rates when treated with VIEKIRA without RBV.
- Results from AbbVie’s GIFT-I study were presented at the Annual Meeting of the
Japan Society for Hepatology. Results demonstrated sustained virologic response 12 weeks post-treatment (SVR12) of 95 percent and 91 percent in Japanese patients with genotype 1b (GT1b) hepatitis C virus (HCV) infection with and without compensated cirrhosis, respectively.
- Enanta was added to
S&Psmall cap 600 Index effective July 28.
- For the quarter ended
June 30, 2015, Enanta’s paritaprevir royalties represented approximately 3 percent of AbbVie’s reported VIEKIRA sales, and Enanta expects its royalties in the quarter ending September 30, 2015to continue to be approximately 3 percent of such sales.
- Based upon AbbVie’s guidance for regulatory approval in
Japanfor its 2-DAA hepatitis C virus treatment regimen, we expect to earn a $30 millionmilestone payment upon reimbursement approval in Japanin the quarter ending December 31, 2015.
Upcoming Events and Presentations
September 10, Baird 2015 Healthcare Conference, New York September 16, 2015 Morgan Stanley Global Healthcare Conference, New York
- Enanta plans to issue its fiscal fourth quarter and year-end financial results press release, and hold a conference call regarding those results, in the week of
November 23, 2015.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for regulatory approval in Japan for AbbVie’s HCV treatment regimen containing paritaprevir, the prospects for AbbVie’s development of a next-generation regimen containing ABT-493, the prospects for advancement of the NASH development program, expectations for a commercialization regulatory approval milestone payment for
|ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
|Three Months Ended||Nine Months Ended|
|June 30,||June 30,|
|Research and development||6,253||4,553||16,140||13,538|
|General and administrative||3,643||2,603||9,850||7,255|
|Total operating expenses||9,896||7,156||25,990||20,793|
|Income from operations||1,703||34,895||120,474||24,311|
|Other income, net||287||36||798||47|
|Income before income taxes||1,990||34,931||121,272||24,358|
|Income tax (expense) benefit||428||15,122||(48,092)||15,122|
|Net income per share|
|Weighted average common shares outstanding|
|ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|June 30,||September 30,|
|Cash and cash equivalents||$||19,844||$||30,699|
|Short-term marketable securities||134,442||60,065|
|Deferred tax assets||1,757||11,123|
|Prepaid expenses and other current assets||3,497||1,594|
|Total current assets||172,640||107,975|
|Property and equipment, net||2,582||1,803|
|Long-term marketable securities||57,657||41,003|
|Deferred tax assets||4,287||4,198|
|Liabilities and Stockholders' Equity|
|Income taxes payable||2,229||-|
|Total current liabilities||7,312||4,746|
|Series 1 nonconvertible preferred stock||185||202|
|Other long-term liabilities||538||229|
|Total stockholders' equity||228,282||148,654|
|Total liabilities and stockholders' equity||$||237,774||$||155,415|