Enanta Pharmaceuticals Reports Financial Results for its Fourth Quarter and Year Ended September 30, 2017
Webcast and Conference Call today at
- Cash and marketable securities totaled
$293.7 millionat September 30, 2017
- Total revenue for the quarter was
- Milestone payments totaling
$65.0 millionreceived following AbbVie’s U.S. approval of MAVYRET™ (glecaprevir/pibrentasvir) and EU approval of MAVIRET™ (glecaprevir/pibrentasvir)
- Positive Phase 1 results for EDP-305 support further clinical evaluation in PBC and NASH patients
- Fast Track designation granted to EDP-305 by the U.S.
FDAfor the treatment of patients with primary biliary cholangitis.
Enanta’s cash, cash equivalents and short-term and long-term marketable
“Enanta has made great progress this past year and has delivered on
several key clinical and financial milestones,” stated
Fiscal Fourth Quarter and Year Ended
Total revenue for the three months ended
Research and development expenses totaled
General and administrative expenses totaled
Enanta recorded income tax expense of
Net income for the three months ended
Development Program and Business Review
October 23, Enanta announced positive results from its Phase 1 clinical study of EDP-305, Enanta’s lead FXR agonist for non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). In this study of single ascending doses (SAD) and multiple doses at ascending dose levels per subject cohort (MAD), EDP-305 was generally safe and well tolerated over a broad range of single and multiple doses with pharmacokinetic (PK) data supporting once daily oral dosing. EDP-305 also exhibited strong engagement of the FXR receptor as evidenced by increased FGF19 levels and reduced C4 levels. These results support the ability to administer EDP-305 in future trials at doses that neither elicited clinically significant changes in lipids nor resulted in pruritus (itching).
- Enanta expects to initiate two clinical studies by the end of 2017: a Phase 2 clinical study of EDP-305 in patients with primary biliary cholangitis (PBC) and a Phase 1 study of respiratory syncytial virus (RSV) development candidate EDP-938 in healthy volunteers. A Phase 2 clinical study of EDP-305 in patients with NASH is expected to begin in early 2018.
The U.S. Food and Drug Administration( FDA) has granted Enanta’s drug candidate EDP-305, an FXR agonist, Fast Track designation for the treatment of patients with primary biliary cholangitis. Bryan Goodwin, Ph.D., has recently joined Enanta as Vice President of Biology. Dr. Goodwin will provide senior leadership to the virology and NASH biology groups.
During the quarter, Enanta received milestone payments of
$65.0 millionfor the U.S. and European approvals of AbbVie’s new MAVYRET™/MAVIRET™ (glecaprevir/pibrentasvir) regimen. Glecaprevir, Enanta’s second protease inhibitor product, is part of this new HCV treatment regimen that will earn royalties for Enanta.
September 27, Enanta announced that AbbViealso received approval in Japanfor MAVIRET™ (glecaprevir/pibrentasvir). Enanta will earn a $15.0 millionmilestone payment from AbbVieupon price reimbursement approval of MAVIRET™ in Japan, which is expected in the quarter ending December 31, 2017.
Financial Guidance for Fiscal Year Ending
Research and development expense between
$90 million and $110 million
General and administration expense between
$22 million and $28 million
Upcoming Events and Presentations
J.P. Morgan Healthcare Conference, January 7-11, 2018
Enanta plans to issue its fiscal first quarter financial results press
release, and hold a conference call regarding those results, on
February 7, 2018.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
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 and RSV, as well as Enanta’s projections of its expenses in 2018. 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
(in thousands, except per share amounts)
|Three Months Ended
|Research and development||16,514||11,500||57,451||40,461|
|General and administrative||5,118||4,440||20,749||16,966|
|Total operating expenses||21,632||15,940||78,200||57,427|
|Income (loss) from operations||54,295||(3,099||)||24,614||30,841|
|Other income, net||660||471||2,333||1,719|
|Income (loss) before income taxes||54,955||(2,628||)||26,947||32,560|
|Income tax (expense) benefit||(18,447||)||826||(9,237||)||(10,894||)|
|Net income (loss)||$||36,508||$||(1,802||)||$||17,710||$||21,666|
|Net income (loss) per share|
|Weighted average common shares outstanding|
|ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||65,675||$||16,577|
|Short-term marketable securities||157,994||193,507|
|Prepaid expenses and other current assets||3,536||9,231|
|Total current assets||237,819||232,156|
|Property and equipment, net||8,049||8,004|
|Long-term marketable securities||70,038||32,119|
|Deferred tax assets||10,123||8,390|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||7,970||4,512|
|Income taxes payable||9,298||-|
|Total current liabilities||20,982||7,889|
|Series 1 nonconvertible preferred stock||762||159|
|Other long-term liabilities||2,410||2,042|
|Total stockholders' equity||301,676||269,936|
|Total liabilities and stockholders' equity||$||326,637||$||281,277|