We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Enanta Pharmaceuticals Inc | NASDAQ:ENTA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 13.56 | 12.36 | 15.31 | 0 | 12:00:04 |
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal second quarter ended March 31, 2021.
“This quarter was marked by meaningful progress, particularly as we further our efforts to develop an all-oral regimen for chronic HBV patients,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “We are especially pleased with the safety, tolerability, pharmacokinetic, and HBV RNA data we announced today from our Phase 1b study in NUC-suppressed patients, which reinforces our belief in EDP-514’s potential to serve as the foundation of an oral combination treatment approach to achieve a functional cure in patients with HBV. We also remain on track for other key milestones in our HBV program later this quarter, including reporting preliminary data from our Phase 1b trial of EDP-514 in viremic chronic HBV patients and initiating a Phase 1 study of EDP-721, our novel HBV RNA destabilizer. Looking to the rest of our pipeline, we are excited to soon initiate IND-enabling studies of a lead oral protease inhibitor specifically designed to target SARS-CoV-2, with a goal of beginning a Phase 1 study in early 2022. Each milestone we achieve brings us closer to our vision of being a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases.”
Fiscal Second Quarter Ended March 31, 2021 Financial Results
Total revenue for the three months ended March 31, 2021 was $20.1 million and consisted of royalty revenue derived primarily from worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), which continued to be adversely impacted by the pandemic. For the three months ended March 31, 2020, total revenue from royalties on AbbVie’s net sales of HCV regimens was $27.6 million.
Research and development expenses totaled $41.5 million for the three months ended March 31, 2021, compared to $32.6 million for the three months ended March 31, 2020. The increase in research and development expenses was primarily due to the timing of the company’s clinical trials year over year.
General and administrative expenses totaled $8.3 million for the three months ended March 31, 2021, compared to $6.9 million for the three months ended March 31, 2020. The increase in general and administrative expenses was due to increased headcount and compensation expense.
Enanta recorded an income tax benefit of $7.1 million for the three months ended March 31, 2021, compared to an income tax benefit of $3.9 million for the same period of 2020. The income tax benefit during the three months ended March 31, 2021 was due to the provision of the CARES Act of 2020, which enables the Company to carry back its projected current year tax loss to offset taxable income in prior years.
Net loss for the three months ended March 31, 2021 was $22.0 million, or a loss of $1.09 per diluted common share, compared to a net loss of $6.0 million, or a loss of $0.30 per diluted common share, for the corresponding period in 2020.
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled $400.4 million at March 31, 2021. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its continuing royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.
Pipeline Programs and Near-Term Milestones
Virology
NASH
Upcoming Events and Presentations
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on May 6, 2021, through 11:59 p.m. ET on May 10, 2021 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for international callers. The passcode for both the live call and the replay is 4283865. A live audio webcast of the call and replay can be accessed by visiting the “Events and Presentation” section on the “Investors” page of Enanta’s website at www.enanta.com.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta’s research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and emerging coronaviruses, including SARS-CoV-2.
Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta and now marketed by AbbVie as part of its leading treatment for chronic HCV infection, is sold under the brand names MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta’s clinical programs in RSV, NASH and HBV, as well as discovery initiatives in SARS-CoV-2, RSV and hMPV. 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: the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, HBV, HCV, COVID-19 and NASH; the discovery and development risks of Enanta’s programs in RSV, HBV, NASH, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; Enanta’s lack of clinical development experience; Enanta’s need to attract and retain senior management and key research and development 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-Q for the quarter ended December 31, 2020, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS UNAUDITED (in thousands, except per share amounts) Three Months Ended Six Months Ended March 31, March 31,2021
2020
2021
2020
Revenue$
20,132
$
27,619
$
51,875
$
80,189
Operating expenses Research and development
41,506
32,610
78,171
65,388
General and administrative
8,326
6,884
15,703
13,805
Total operating expenses
49,832
39,494
93,874
79,193
Income (loss) from operations
(29,700
)
(11,875
)
(41,999
)
996
Other income, net
545
1,950
1,222
4,026
Income (loss) before income taxes
(29,155
)
(9,925
)
(40,777
)
5,022
Income tax benefit
7,110
3,920
10,404
2,416
Net income (loss)$
(22,045
)
$
(6,005
)
$
(30,373
)
$
7,438
Net income (loss) per share Basic$
(1.09
)
$
(0.30
)
$
(1.51
)
$
0.37
Diluted$
(1.09
)
$
(0.30
)
$
(1.51
)
$
0.36
Weighted average common shares outstanding Basic
20,171
19,922
20,131
19,836
Diluted
20,171
19,922
20,131
20,692
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS UNAUDITED (in thousands) March 31, September 30,2021
2020
Assets Current assets Cash and cash equivalents$
77,126
$
87,131
Short-term marketable securities
298,821
299,518
Accounts receivable
20,132
23,492
Prepaid expenses and other current assets
32,140
26,696
Total current assets
428,219
436,837
Long-term marketable securities
24,493
32,634
Property and equipment, net
7,038
8,596
Deferred tax assets
345
345
Operating lease, right-of-use assets
6,972
7,020
Restricted cash
608
608
Other long-term assets
92
92
Total assets$
467,767
$
486,132
Liabilities and Stockholders' Equity Current liabilities Accounts payable$
5,699
$
5,737
Accrued expenses and other current liabilities
15,744
14,159
Operating lease liabilities
5,175
4,261
Total current liabilities
26,618
24,157
Operating lease liabilities, net of current portion
2,644
3,838
Series 1 nonconvertible preferred stock
1,479
1,479
Other long-term liabilities
994
1,078
Total liabilities
31,735
30,552
Total stockholders' equity
436,032
455,580
Total liabilities and stockholders' equity$
467,767
$
486,132
View source version on businesswire.com: https://www.businesswire.com/news/home/20210506006072/en/
Media and Investor Contact: Jennifer Viera 617-744-3848 jviera@enanta.com
1 Year Enanta Pharmaceuticals Chart |
1 Month Enanta Pharmaceuticals Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions