Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017
Webcast and Conference Call today at
- Royalty revenue was
- R&D expense increased to
$13.0 millionin support of pipeline development
- Cash and marketable securities totaled
$240.9 millionat March 31, 2017
Enanta’s cash, cash equivalents and short-term and long-term marketable
Fiscal Second Quarter Ended
Total revenue for the three months ended
Research and development expenses totaled
General and administrative expenses totaled
Enanta recorded an income tax benefit for the three months ended March
31, 2017 of $3.6 million compared to an income tax expense of
Net loss for the three months ended
“With our second partnered protease inhibitor product, glecaprevir,
expected to launch starting in August as part of AbbVie’s new,
investigational G/P treatment for HCV, the prospects for additional
milestone and royalty payments to us for G/P are significant,” stated
Development Program and Business Review
Enanta presented new preclinical data on EDP-305, its wholly-owned FXR
agonist for non-alcoholic steatohepatitis, at the International Liver
Congress™ (ILC) 2017 in
Amsterdam. Data from three poster presentations presented at the Congressdemonstrated that EDP-305 is a potent Farnesoid X receptor (FXR) agonist that has been shown to reduce expression of fibrogenic genes, reduce fibrosis progression and improve non-alcoholic fatty liver disease (NAFLD) activity scores (NAS) in a variety of preclinical models.
- Enanta expects to present clinical data from our ongoing Phase 1 clinical study of EDP-305 in healthy volunteers and presumed NAFLD subjects1 and to initiate NASH-enabling studies in the second half of this year. A Phase 2 study in PBC is expected to begin in the fourth quarter of calendar 2017 and Phase 2 studies in NASH are expected to begin in early 2018.
Also at the ILC,
AbbViepresented new data from its investigational, pan-genotypic, ribavirin-free regimen for hepatitis C virus (HCV) consisting of a combination of glecaprevir/pibrentasvir (G/P). Data from the EXPEDITION-1 study demonstrated that 99 percent (n=145/146) of chronic HCV infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with G/P. This high SVR12 rate was seen following 12 weeks of G/P treatment without ribavirin. Data were also presented at the ILC from the ENDURANCE-3 study. In this study, 95 percent (n=149/157) of genotype 3 (GT3) chronic HCV-infected patients without cirrhosis and who were new to treatment, achieved sustained virologic response at 12 weeks post-treatment (SVR12) following 8 weeks of treatment with G/P.
In March, Enanta announced the
Japanese Ministry of Health, Labour and Welfare(MHLW) granted priority review designation to AbbVie’s G/P combination for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV) infection. AbbViehad submitted the NDA for the G/P regimen in Japanin February 2017. The NDAs for G/P in the U.S and Japanhave been granted priority review designation, and the MAA for G/P has been granted accelerated assessment in the E.U.
Upcoming Events and Presentations
June 25at the XIX International Symposium on Respiratory Viral Infections in Berlin, Germany, Enanta will present data on EDP-938, its respiratory syncytial virus inhibitor candidate in an oral presentation titled: “EDP-938, a Novel Non-Fusion Replication Inhibitor of Respiratory Syncytial Virus, Demonstrates Potent Antiviral Activities both In Vitro and In Vivo”.
Enanta plans to issue its fiscal third quarter financial results press
release, and hold a conference call regarding those results, on
August 7, 2017.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with
Forward Looking Statements
This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie’s investigational G/P regimen in HCV and the prospects for advancement of Enanta’s earlier stage programs in NASH/PBC and RSV. 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 efforts to obtain regulatory approvals for G/P and commercialize that regimen; 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 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
1 Presumed NAFLD subjects in this study are obese subjects, with or without pre-diabetes or type-2 diabetes.
ENANTA PHARMACEUTICALS, INC.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|March 31,||March 31,|
|Research and Development||13,004||9,143||25,530||18,176|
|General and administrative||5,461||4,426||10,398||8,244|
|Total operating expenses||18,465||13,569||35,928||26,420|
|Income (loss) from operations||(9,506||)||(565||)||(16,552||)||35,029|
|Other income, net||549||472||1,073||801|
|Income (loss) before income taxes||(8,957||)||(93||)||(15,479||)||35,830|
|Income tax (expense) benefit||3,565||(1,552||)||5,107||(11,286||)|
|Net income (loss)||$||(5,392||)||$||(1,645||)||$||(10,372||)||$||24,544|
|Net income (loss) per share|
|Weighted average common shares outstanding|
ENANTA PHARMACEUTICALS, INC.
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||September 30,|
|Cash and cash equivalents||$||19,211||$||16,577|
|Short-term marketable securities||156,362||193,507|
|Prepaid expenses and other current assets||6,059||9,231|
|Total current assets||190,591||232,156|
|Property and equipment, net||8,526||8,004|
|Long-term marketable securities||65,330||32,119|
|Deferred tax assets||13,903||8,390|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||5,098||4,512|
|Total current liabilities||9,154||7,889|
|Series 1 nonconvertible preferred stock||162||159|
|Other long-term liabilities||2,355||2,042|
|Total stockholders' equity||266,011||269,936|
|Total liabilities and stockholders' equity||$||278,958||$||281,277|