Enanta Pharmaceuticals Reports Financial Results for the Fiscal Fourth Quarter and Year Ended September 30, 2013
Fiscal Fourth Quarter and Year Ended
Revenue for the three months ended
Research and development expenses totaled
General and administrative expenses totaled
Net loss for the three months ended
Cash, cash equivalents and marketable securities totaled
“2013 was a transformational year for Enanta,” stated
Pipeline and Business Review
- Enanta recently announced results from the SAPPHIRE-I study, one of six phase 3 registrational studies being conducted by
AbbVie for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, using a regimen containing Enanta’s lead protease inhibitor ABT-450. Results demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in treatment-naive adult patients chronically infected with GT1 HCV. Results from the remaining five ABT-450 containing studies will be available in the coming months, supporting regulatory submissions starting in the second quarter of 2014. - Data from AbbVie’s PEARL-1 study was presented at the AASLD meeting on
November 3, 2013 . In an intent-to-treat analysis, a two-direct acting antiviral HCV regimen which included ABT-450, produced SVR12 results of 95% in GT 1b, treatment-naïve HCV patients and SVR12 results of 90% in prior null responders, without the use of interferon or ribavirin The National Institute of Allergy and Infectious Diseases (NIAID) awarded Enanta an additional$9.2 million to further fund development of Enanta’s new class of bridged bicyclic antibiotics known as Bicyclolides.- Bicyclolide EDP-788 is targeted to begin phase 1 clinical studies in the first half of calendar 2014.
Upcoming Events and Presentations
Enanta management will participate at the Deutsche Bank BioFest investor conference in
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
About Enanta
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for further clinical development of ABT-450 and EDP-788, the expected timeline for announcement of results of Phase III studies of regimens that include ABT-450, and the projected sufficiency of Enanta’s cash equivalent resources. 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 reliance on the development and commercialization efforts of
ENANTA PHARMACEUTICALS, INC. | |||||||||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||||||||||||
Revenue | $ | 1,349 | $ | 1,858 | $ | 32,053 | $ | 41,706 | |||||||||||||||||||||
Operating expenses | |||||||||||||||||||||||||||||
Research and development | 4,300 | 4,255 | 16,841 | 15,115 | |||||||||||||||||||||||||
General and administrative | 1,750 | 1,699 | 6,183 | 5,302 | |||||||||||||||||||||||||
Total operating expenses | 6,050 | 5,954 | 23,024 | 20,417 | |||||||||||||||||||||||||
Income (loss) from operations | (4,701) | (4,096) | 9,029 | 21,289 | |||||||||||||||||||||||||
Other income, net | 258 | 44 | 598 | 110 | |||||||||||||||||||||||||
Net income (loss) | (4,443) | (4,052) | 9,627 | 21,399 | |||||||||||||||||||||||||
Liabilities, Preferred Stock and Stockholders' Equity (Deficit) | |||||||||||||||||||||||||||||
to redemption value | - | (1,332) | (2,526) | (5,367) | |||||||||||||||||||||||||
Net income attributable to participating securities | - | - | (13,670) | (14,663) | |||||||||||||||||||||||||
Net income (loss) attributable to common stockholders | $ | (4,443) | $ | (5,384) | $ | (6,569) | $ | 1,369 | |||||||||||||||||||||
Net income (loss) per share attributable to common stockholders | |||||||||||||||||||||||||||||
Basic | $ | (0.25) | $ | (4.78) | $ | (0.67) | $ | 1.26 | |||||||||||||||||||||
Diluted | $ | (0.25) | $ | (4.78) | $ | (0.67) | $ | 1.13 | |||||||||||||||||||||
Weighted average common shares outstanding | |||||||||||||||||||||||||||||
Basic | 17,904 | 1,127 | 9,788 | 1,089 | |||||||||||||||||||||||||
Diluted | 17,904 | 1,127 | 9,788 | 2,475 | |||||||||||||||||||||||||
ENANTA PHARMACEUTICALS, INC. | ||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||||||
(in thousands) | ||||||||||||||
September 30, | September 30, | |||||||||||||
2013 | 2012 | |||||||||||||
Assets | ||||||||||||||
Current assets | ||||||||||||||
Cash and cash equivalents | $ | 8,859 | $ | 10,511 | ||||||||||
Short-term marketable securities | 92,621 | 33,251 | ||||||||||||
Accounts receivable | 808 | 1,049 | ||||||||||||
Unbilled receivables | 784 | 1,893 | ||||||||||||
Prepaid expenses and other current assets | 1,641 | 604 | ||||||||||||
Total current assets | 104,713 | 47,308 | ||||||||||||
Property and equipment, net | 1,121 | 611 | ||||||||||||
Long-term marketable securities | 10,703 | 1,656 | ||||||||||||
Restricted cash | 436 | 436 | ||||||||||||
Other assets | - | 2,151 | ||||||||||||
Total assets | $ | 116,973 | $ | 52,162 | ||||||||||
Liabilities, Preferred Stock and Stockholders' Equity (Deficit) | ||||||||||||||
Current liabilities | ||||||||||||||
Accounts payable | $ | 1,481 | $ | 1,851 | ||||||||||
Accrued expenses | 3,035 | 3,866 | ||||||||||||
Deferred revenue | 10 | 17 | ||||||||||||
Total current liabilities | 4,526 | 5,734 | ||||||||||||
Warrant liability | 1,620 | 2,001 | ||||||||||||
Other long-term liabilities | 359 | 498 | ||||||||||||
Total liabilities | 6,505 | 8,233 | ||||||||||||
Redeemable convertible preferred stock | - | 158,955 | ||||||||||||
Convertible preferred stock | - | 327 | ||||||||||||
Total stockholders' equity (deficit) | 110,468 | (115,353) | ||||||||||||
Total liabilities, preferred stock and stockholders' equity (deficit) | $ | 116,973 | $ | 52,162 | ||||||||||
Source:
Investor
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com
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