Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2017
Webcast and Conference Call today at
- Total revenue for the quarter was
$38.1 million - Net income for the quarter was
$11.7 million , or$0.59 per diluted common share - Cash and marketable securities totaled
$297.5 million atDecember 31, 2017 and include the milestone payment of$15.0 million received following reimbursement approval of AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) inJapan - Recruitment initiated in Phase 2, “ARGON-1” study of EDP-305 in NASH
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled
“We are pleased that we have now initiated recruitment in our Phase 2 “ARGON-1” study in NASH. We now have three ongoing clinical programs, in NASH, PBC and RSV,” stated
Fiscal First Quarter Ended
Total revenue for the three months ended
Research and development expenses totaled
General and administrative expenses totaled
Enanta recorded income tax expense of
The first quarter tax provision is based on various estimates and current analysis of the recently enacted tax legislation. Given the expectation of further guidance with respect to such legislation and its financial accounting from the U.S. Treasury,
Net income for the three months ended
Development Programs and Business Review
- A Phase 2 dose-ranging clinical study of EDP-305, Enanta’s lead FXR agonist, has been initiated in patients with PBC. This Phase 2 clinical study, named “INTREPID”, is a 12-week, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in subjects with PBC, with or without an inadequate response to ursodeoxycholic acid. The efficacy of EDP-305 will be assessed by evaluating reductions in levels of alkaline phosphatase (ALP) versus placebo.
- Enanta has recently initiated recruitment of a Phase 2 dose-ranging clinical study of EDP-305 in NASH patients. This Phase 2 clinical study, named “ARGON-1”, is a 12-week, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in subjects with NASH. This proof-of-concept Phase 2 study will assess safety and changes in alanine transaminase (ALT) levels as a primary endpoint and will also focus on evaluating multiple secondary endpoints, including imaging and non-invasive markers of fibrosis and steatosis at Week 12.
- Data was presented at the 2018 NASH-TAG conference in
Park City, Utah ,January 4-6, 2018 , from Enanta’s Phase 1 study of EDP-305 in healthy subjects and in subjects with presumptive non-alcoholic fatty liver disease (NAFLD). Top line results were first announced onOctober 23, 2017 . - A Phase 1 clinical study of EDP-938, a potent non-fusion inhibitor of both RSV-A and RSV-B activity, has been initiated. The objective of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending dose (SAD) and multiple ascending dose (MAD) levels of EDP-938 in healthy volunteers. Upon successful completion of this study, a Phase 2 proof-of-concept challenge study in RSV-infected humans is expected to begin in the fourth quarter of calendar 2018.
- Preclinical lead optimization continues to progress in our HBV program with the goal of identifying a development candidate in calendar 2018.
- On November 30, Enanta announced reimbursement approval in Japan for AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) and earned the remaining
$15.0 million milestone under theAbbVie collaboration.
Upcoming Events and Presentations
February 21, 2018 –RBC Capital Markets 2018 Global Healthcare Conference,New York February 28, 2018 – Enanta Annual Meeting of Stockholders,4:00 p.m. ET ,Watertown, MA - Enanta plans to issue its fiscal second quarter financial results press release, and hold a conference call regarding those results, on
May 8, 2018 .
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
About Enanta
Royalties and milestone payments from the
Forward Looking Statements
This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie’s MAVYRET/MAVIRET regimen in HCV and the prospects for advancement of Enanta’s earlier stage programs in NASH, PBC, RSV and HBV. 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 and its new MAVYRET/MAVIRET regimen; competitive pricing, market acceptance and reimbursement rates for AbbVie’s HCV treatment regimens compared to competitive HCV products on the market; the discovery and development risks of early stage discovery efforts in other disease areas such as NASH, PBC, RSV and HBV; potential competition from the development efforts of others in those other 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 | ||||||||||
| UNAUDITED | ||||||||||
| (in thousands, except per share amounts) | ||||||||||
| Three Months Ended | ||||||||||
| December 31, | ||||||||||
| 2017 | 2016 | |||||||||
| Revenue | $ | 38,109 | $ | 10,417 | ||||||
| Operating expenses | ||||||||||
| Research and development | 17,962 | 12,526 | ||||||||
| General and administrative | 5,770 | 4,937 | ||||||||
| Total operating expenses | 23,732 | 17,463 | ||||||||
| Income (loss) from operations | 14,377 | (7,046) | ||||||||
| Other income, net | 960 | 524 | ||||||||
| Income (loss) before income taxes | 15,337 | (6,522) | ||||||||
| Income tax (expense) benefit | (3,644) | 1,542 | ||||||||
| Net income (loss) | $ | 11,693 | $ | (4,980) | ||||||
| Net income (loss) per share | ||||||||||
| Basic | $ | 0.61 | $ | (0.26) | ||||||
| Diluted | $ | 0.59 | $ | (0.26) | ||||||
| Weighted average common shares outstanding | ||||||||||
| Basic | 19,130 | 19,038 | ||||||||
| Diluted | 19,918 | 19,038 | ||||||||
| ENANTA PHARMACEUTICALS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| UNAUDITED | ||||||||
| (in thousands) | ||||||||
| December 31, | September 30, | |||||||
| 2017 | 2017 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 68,053 | $ | 65,675 | ||||
| Short-term marketable securities | 152,389 | 157,994 | ||||||
| Accounts receivable | 23,109 | 10,614 | ||||||
| Prepaid expenses and other current assets | 4,075 | 3,536 | ||||||
| Total current assets | 247,626 | 237,819 | ||||||
| Property and equipment, net | 7,870 | 8,049 | ||||||
| Long-term marketable securities | 77,047 | 70,038 | ||||||
| Deferred tax assets | 7,568 | 10,123 | ||||||
| Restricted cash | 608 | 608 | ||||||
| Total assets | $ | 340,719 | $ | 326,637 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,268 | $ | 3,714 | ||||
| Accrued expenses and other current liabilities | 5,697 | 7,970 | ||||||
| Income taxes payable | 10,257 | 9,298 | ||||||
| Total current liabilities | 19,222 | 20,982 | ||||||
| Warrant liability | - | 807 | ||||||
| Series 1 nonconvertible preferred stock | 1,528 | 762 | ||||||
| Other long-term liabilities | 2,390 | 2,410 | ||||||
| Total liabilities | 23,140 | 24,961 | ||||||
| Total stockholders' equity | 317,579 | 301,676 | ||||||
| Total liabilities and stockholders' equity | $ | 340,719 | $ | 326,637 | ||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20180207006067/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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