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 first quarter ended December 31, 2021.
“We are excited to begin dosing subjects this month with EDP-235, our SARS-CoV-2 3CL protease inhibitor specifically designed as a once-daily, orally-dosed treatment for COVID-19. As the COVID-19 pandemic continues, demand for a convenient, once-daily therapeutic is stronger than ever, and we look forward to advancing EDP-235 as a COVID-19 treatment option based on its potential best-in-class preclinical profile,” said Jay R. Luly Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “Building on our respiratory virus portfolio, we also made significant progress in our RSV programs. Last quarter we completed enrollment in RSVP, our Phase 2b Study of EDP-938 in adults with community-acquired RSV, and we are eager to report topline data next quarter. Additionally, last month, we were pleased to introduce EDP-323, an RSV L-protein inhibitor that can be used alone or in combination with EDP-938 to potentially broaden the addressable patient populations or their treatment windows, and we plan to initiate a Phase 1 study of EDP-323 in the second half of 2022. Importantly, we remain committed to developing a functional cure for chronic hepatitis B virus patients with EDP-514, our lead core inhibitor, in combination with other mechanisms. We believe that a potent core inhibitor such as EDP-514 will be an important component of a successful combination treatment regimen.”
Fiscal First Quarter Ended December 31, 2021 Financial Results
Total revenue for the three months ended December 31, 2021 was $27.6 million and consisted entirely of royalty revenue from worldwide net sales of MAVYRET®/MAVIRET®, AbbVie’s eight-week treatment for chronic hepatitis C virus (HCV). For the three months ended December 31, 2020, total royalty revenue was $31.7 million on AbbVie’s sales of MAVYRET/MAVIRET. As reported by AbbVie, treated patient volumes remain suppressed compared to pre-COVID levels.
Research and development expenses totaled $48.5 million for the three months ended December 31, 2021, compared to $36.7 million for the three months ended December 31, 2020. The increase was primarily due to the timing of manufacturing in support of the company’s clinical studies in its virology programs.
General and administrative expenses totaled $9.5 million for the three months ended December 31, 2021, compared to $7.4 million for the three months ended December 31, 2020. This increase was primarily due to additional headcount and compensation expense.
Enanta recorded a minor income tax benefit related to the release of a state tax reserve for the three months ended December 31, 2021 compared to an income tax benefit of $3.3 million for the same period in 2020. Enanta recorded a larger income tax benefit in 2020 than in 2021 due to the provision of the CARES Act of 2020, which enabled the company to carry back its tax loss in the 2020 period to offset taxable income in prior years. This provision does not apply to periods ending after September 30, 2021.
Net loss for the three months ended December 31, 2021 was $30.1 million, or a loss of $1.48 per diluted common share, compared to a net loss of $8.3 million, or a loss of $0.41 per diluted common share, for the corresponding period in 2020.
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled $347.7 million at December 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 at least the next two years.
Pipeline Update and Business Review
Respiratory Syncytial Virus (RSV)
COVID-19 (SARS-CoV-2)
Hepatitis B Virus (HBV)
Human Metapneumovirus (hMPV)
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 844-467-7101 in the U.S. or 270-215-9353 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on February 8, 2022, through 11:59 p.m. ET on February 15, 2022, 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 3458965. A live audio webcast of the call and replay can be accessed by visiting the “Events and Presentations” 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 programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV).
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, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames 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, SARS-CoV-2 and HBV and its preclinical program in 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, SARS-CoV-2 and HBV; the discovery and development risks of Enanta’s programs in RSV, SARS-CoV-2, HBV and hMPV; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on business operations and clinical trials; 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 Form 10-K for the fiscal year ended September 30, 2021, and any 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 |
||||||||
December 31, |
||||||||
2021 |
|
2020 |
||||||
Revenue | $ |
27,648 |
|
$ |
31,743 |
|
||
Operating expenses | ||||||||
Research and development |
|
48,549 |
|
|
36,665 |
|
||
General and administrative |
|
9,508 |
|
|
7,377 |
|
||
Total operating expenses |
|
58,057 |
|
|
44,042 |
|
||
Loss from operations |
|
(30,409 |
) |
|
(12,299 |
) |
||
Other income, net |
|
258 |
|
|
677 |
|
||
Loss before income taxes |
|
(30,151 |
) |
|
(11,622 |
) |
||
Income tax benefit |
|
36 |
|
|
3,294 |
|
||
Net loss | $ |
(30,115 |
) |
$ |
(8,328 |
) |
||
Net loss per share | ||||||||
Basic | $ |
(1.48 |
) |
$ |
(0.41 |
) |
||
Diluted | $ |
(1.48 |
) |
$ |
(0.41 |
) |
||
Weighted average common shares outstanding | ||||||||
Basic |
|
20,388 |
|
|
20,093 |
|
||
Diluted |
|
20,388 |
|
|
20,093 |
|
||
ENANTA PHARMACEUTICALS, INC. | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
UNAUDITED | ||||||
(in thousands) | ||||||
December 31, |
|
September 30, |
||||
2021 |
|
2021 |
||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | $ |
99,068 |
$ |
57,206 |
||
Short-term marketable securities |
|
159,984 |
|
186,796 |
||
Accounts receivable |
|
27,648 |
|
23,576 |
||
Prepaid expenses and other current assets |
|
11,506 |
|
14,188 |
||
Income tax receivable |
|
28,751 |
|
37,255 |
||
Total current assets |
|
326,957 |
|
319,021 |
||
Long-term marketable securities |
|
88,668 |
|
108,416 |
||
Property and equipment, net |
|
5,435 |
|
5,943 |
||
Operating lease, right-of-use assets |
|
18,834 |
|
4,711 |
||
Restricted cash |
|
608 |
|
608 |
||
Other long-term assets |
|
92 |
|
92 |
||
Total assets | $ |
440,594 |
$ |
438,791 |
||
Liabilities and Stockholders' Equity | ||||||
Current liabilities | ||||||
Accounts payable | $ |
7,841 |
$ |
9,540 |
||
Accrued expenses and other current liabilities |
|
26,580 |
|
22,429 |
||
Operating lease liabilities |
|
3,469 |
|
4,203 |
||
Total current liabilities |
|
37,890 |
|
36,172 |
||
Operating lease liabilities, net of current portion |
|
15,958 |
|
1,126 |
||
Series 1 nonconvertible preferred stock |
|
1,506 |
|
1,506 |
||
Other long-term liabilities |
|
856 |
|
558 |
||
Total liabilities |
|
56,210 |
|
39,362 |
||
Total stockholders' equity |
|
384,384 |
|
399,429 |
||
Total liabilities and stockholders' equity | $ |
440,594 |
$ |
438,791 |
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