Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year Ended September 30, 2016
Conference Call and Webcast Today at
- Royalty revenue increased
$23.6 million year over year - R&D expense increased
$17.3 million year over year in support of pipeline development - Phase 1 clinical study initiated with EDP-305, Enanta’s lead Farnesoid X Receptor (FXR) agonist candidate for NASH and Primary Biliary Cholangitis (PBC), in healthy adults and in adults with presumptive non-alcoholic fatty liver disease (NAFLD)
- Cash and marketable securities totaled
$242.2 million atSeptember 30, 2016
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled
Fiscal Fourth Quarter and Year Ended
Revenue from royalties on AbbVie’s hepatitis C virus (HCV) treatment regimens was
Research and development expenses totaled
General and administrative expenses totaled
Enanta recorded an income tax benefit for the three months ended
Net loss for the three months ended
“Enanta made significant progress this past year and executed on its stated goals for advancing our pipeline,” commented
Development Program and Business Review for the Quarter
Hepatitis C Virus (HCV)
AbbVie announced results from several Phase 3 studies of its investigational pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with HCV, in which 97.5 percent of chronic HCV infected patients without cirrhosis and new to treatment across all major genotypes (GT1-6) achieved SVR12 with just 8 weeks of G/P treatment.AbbVie also announced results of its EXPEDITION-4 study in chronic HCV patients with chronic kidney disease (CKD), in which 98 percent (n=102/104 of patients across all major genotypes (GT1-6) achieved SVR12 with 12 weeks of treatment with G/P.AbbVie expects to file a New Drug Application with theU.S. Food and Drug Administration by the end of 2016 and to file Marketing Authorization Applications outside the U.S. during the first quarter of 2017.AbbVie anticipates commercialization of G/P in the U.S. in 2017. Glecaprevir is Enanta’s next-generation protease inhibitor, which is being developed byAbbVie in combination with pibrentasvir (ABT-530), AbbVie’s next-generation NS5A Inhibitor.The U.S. Food and Drug Administration (FDA ) has granted Breakthrough Therapy Designation for the G/P combination for the treatment of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs), including previous therapy with an NS5A inhibitor and/or protease inhibitor.
NASH (non-alcoholic steatohepatitis)
- Several poster presentations regarding Enanta’s wholly-owned pipeline program in NASH were presented at The Liver Meeting® in November. Preclinical data presented demonstrated that EDP-305 is a potent and selective FXR agonist that reduces fibrosis progression and shows favorable lipid metabolism in pre-clinical models.
- In September Enanta initiated a phase 1 clinical study of EDP-305, its lead Farnesoid X Receptor (FXR) agonist candidate for NASH and Primary Biliary Cholangitis (PBC), in healthy adults and in adults with presumptive non-alcoholic fatty liver disease (NAFLD).
Respiratory Syncytial Virus (RSV)
- Enanta presented promising data on EP-023938, a lead compound for the treatment of Respiratory Syncytial Virus (RSV) based on promising preclinical data presented at the 10th Annual
Respiratory Syncytial Virus Conference inSeptember 2016 . Data demonstrated that EP-023938 is a potent inhibitor of both RSV-A and RSV-B with a high barrier to resistance post-infection, and maintains antiviral potency across all clinical isolates tested, as well as virus that was resistant to fusion inhibitors.
Financial Guidance
- For the full fiscal year ending
September 30, 2017 , Enanta expects to incur between$50.0 and $60.0 million of research and development expense.
Upcoming Events and Presentations
J.P. Morgan Healthcare conferenceJanuary 9-12, 2017 ,San Francisco, CA - Enanta plans to issue its fiscal first quarter 2017 financial results press release, and hold a conference call regarding those results, during the week of
February 6, 2017 .
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
About Enanta
Enanta has discovered novel protease inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). These protease inhibitors, developed through Enanta’s collaboration with
Enanta has also discovered EDP-305, an FXR agonist product candidate for NASH, currently in Phase 1 clinical development, as well as a cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for HCV, which is also in Phase 1 clinical development. In addition, Enanta has early lead candidates for HBV and RSV in preclinical development. Please visit www.enanta.com for more information on our programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for further clinical development of EDP-305 for the treatment of NASH and EDP-494 for the treatment of HCV, the prospects for advancement of Enanta’s other programs in HBV and RSV, 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 in the short-term are dependent upon the success of AbbVie’s continuing commercialization efforts for its HCV treatment regimens containing paritaprevir; Enanta’s longer term revenues will be dependent upon the success of AbbVie’s planned regulatory approval and commercialization of G/P, its investigational HCV treatment combination containing glecaprevir (ABT-493); competitive pricing, market acceptance and reimbursement rates of AbbVie’s treatment regimens containing paritaprevir or its G/P combination 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 such as HBV, NASH and RSV; 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
ENANTA PHARMACEUTICALS, INC. | |||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||||
Revenue | $ | 12,841 | $ | 14,416 | $ | 88,268 | $ | 160,880 | |||||||||||||||
Operating expenses | |||||||||||||||||||||||
Research and development | 11,500 | 7,049 | 40,461 | 23,189 | |||||||||||||||||||
General and administrative | 4,440 | 3,693 | 16,966 | 13,543 | |||||||||||||||||||
Total operating expenses | 15,940 | 10,742 | 57,427 | 36,732 | |||||||||||||||||||
Income (loss) from operations | (3,099) | 3,674 | 30,841 | 124,148 | |||||||||||||||||||
Other income, net | 471 | 509 | 1,719 | 1,307 | |||||||||||||||||||
Income (loss) before income taxes | (2,628) | 4,183 | 32,560 | 125,455 | |||||||||||||||||||
Income tax (expense) benefit | 826 | 1,629 | (10,894) | (46,463) | |||||||||||||||||||
Net income (loss) | $ | (1,802) | $ | 5,812 | $ | 21,666 | $ | 78,992 | |||||||||||||||
Net income (loss) per share | |||||||||||||||||||||||
Basic | $ | (0.09) | $ | 0.30 | $ | 1.14 | $ | 4.23 | |||||||||||||||
Diluted | $ | (0.09) | $ | 0.29 | $ | 1.13 | $ | 4.09 | |||||||||||||||
Weighted average common shares outstanding | |||||||||||||||||||||||
Basic | 19,036 | 18,714 | 18,929 | 18,673 | |||||||||||||||||||
Diluted | 19,036 | 19,337 | 19,224 | 19,295 |
ENANTA PHARMACEUTICALS, INC. | |||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
(in thousands) | |||||||||||
September 30, | September 30, | ||||||||||
2016 | 2015 | ||||||||||
Assets | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | $ | 16,577 | $ | 21,726 | |||||||
Short-term marketable securities | 193,507 | 123,479 | |||||||||
Accounts receivable | 12,841 | 15,289 | |||||||||
Unbilled receivables | - | 433 | |||||||||
Deferred tax assets | - | 1,447 | |||||||||
Prepaid expenses and other current assets | 9,231 | 8,267 | |||||||||
Total current assets | 232,156 | 170,641 | |||||||||
Property and equipment, net | 8,004 | 5,886 | |||||||||
Long-term marketable securities | 32,119 | 64,238 | |||||||||
Deferred tax assets | 8,390 | 4,640 | |||||||||
Restricted cash | 608 | 608 | |||||||||
Total assets | $ | 281,277 | $ | 246,013 | |||||||
Liabilities and Stockholders' Equity | |||||||||||
Current liabilities | |||||||||||
Accounts payable | $ | 3,377 | $ | 1,543 | |||||||
Accrued expenses and other current liabilities | 4,512 | 3,962 | |||||||||
Income taxes payable | - | 1,199 | |||||||||
Total current liabilities | 7,889 | 6,704 | |||||||||
Warrant liability | 1,251 | 1,276 | |||||||||
Series 1 nonconvertible preferred stock | 159 | 163 | |||||||||
Other long-term liabilities | 2,042 | 1,713 | |||||||||
Total liabilities | 11,341 | 9,856 | |||||||||
Total stockholders' equity | 269,936 | 236,157 | |||||||||
Total liabilities and stockholders' equity | $ | 281,277 | $ | 246,013 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20161121005884/en/
Source:
Investor Contact
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com
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