Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year Ended September 30, 2021 with Webcast and Conference Call Today at 4:30 p.m. ET
Enanta Pharmaceuticals has presented first preclinical data for EDP-235, an oral protease inhibitor targeting COVID-19, and reported positive Phase 1b results for EDP-514 in chronic HBV patients. The company terminated the development of EDP-721 due to safety concerns. For the fiscal year ended September 30, 2021, total revenue was $97.1 million, down from $122.5 million in 2020, primarily from unchanged royalty revenue of $23.6 million. Enanta recorded a net loss of $79.0 million for the year. The company expects sufficient cash to meet operational needs for at least two years.
- Presented positive Phase 1b data for EDP-514, showing significant HBV DNA reductions in chronic patients.
- First preclinical data for EDP-235 demonstrated effective SARS-CoV-2 replication inhibition.
- Cash reserves of $352.4 million expected to cover expenses for at least two years.
- Total revenue declined to $97.1 million in the fiscal year, down from $122.5 million in 2020.
- Increased R&D expenses rose to $174.1 million, compared to $136.8 million in 2020.
- Terminated clinical development of EDP-721 due to adverse safety signals.
- Presented First Preclinical Data for EDP-235, an Oral Protease Inhibitor Specifically Designed for the Treatment of COVID-19; First-in-Human Study Planned for Early 2022
-
Reported Positive Clinical Data from Two Phase 1b Studies of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic and NUC-Suppressed Chronic HBV Patients;
Terminated Clinical Development of EDP-721, an Oral HBV RNA Destabilizer - Announced Decision to Pursue Combination Approaches with Farnesoid X Receptor (FXR) Agonists for Non-Alcoholic Steatohepatitis (NASH) Through an Out-Licensing Strategy
-
Royalty Revenue for the Quarter was
$23.6 Million
“We ended fiscal 2021 achieving multiple milestones including presenting positive Phase 1b data of EDP-514 in two major HBV patient populations,” stated
Fiscal Fourth Quarter and Year Ended
Total revenue of
Research and development expenses were
General and administrative expenses totaled
Enanta recorded an income tax benefit of
Net loss for the three months ended
Enanta’s cash, cash equivalents and marketable securities totaled
Financial Guidance for Fiscal Year 2022
-
Research and Development Expense:
$150 million $170 million -
General and Administrative Expense:
$35 million $41 million
Pipeline Programs – Recent Events and Near-Term Milestones
Virology
-
Respiratory Syncytial Virus (RSV): N-Protein Inhibitor EDP-938
- Evaluating EDP-938, an N-protein inhibitor, in a broad clinical development program, consisting of three ongoing Phase 2 trials: RSVP, RSVTx and RSVPEDs.
-
Continued to establish additional trial sites worldwide for RSVP, which is designed to study the effect of EDP-938 on community-acquired RSV infection in an adult population. While RSV, like influenza, was significantly suppressed while there were mitigation measures in place to control COVID-19, more recently there has been evidence of increased RSV activity in various regions of the world, including parts of
the United States andEurope . Enanta expects that enrollment in the RSVP study will be complete during the Northern Hemisphere winter season, if there is no further significant increase in COVID-19 or mitigation measures in those regions. Assuming this enrollment occurs, the company expects data in the first half of 2022. - For RSVTx and RSVPEDs, which were initiated more recently, enrollment is expected to require more than one global RSV season, subject to the uncertainties of the continuing pandemic.
-
COVID-19 (SARS-CoV-2): Protease Inhibitor EDP-235
-
Presented preclinical data during the
International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)–World Health Organization (WHO) Virtual Conference 2021 demonstrating that oral EDP-235 selectively blocked replication of SARS-CoV-2 in multiple cellular models with nanomolar potency. Further, antiviral activity was maintained against multiple SARS-CoV-2 variants. Good distribution to lung cells was observed with optimized pharmacokinetic properties supporting once-daily, oral dosing without ritonavir boosting. Enanta plans to move EDP-235 into the clinic in early 2022.
-
Presented preclinical data during the
-
HBV: Core Inhibitor EDP-514 and HBV RNA Destabilizer EDP-721
- Announced positive final data from both Phase 1b studies of EDP-514 in viremic and NUC-suppressed chronic HBV patients. These data demonstrated that the 200 mg, 400 mg, and 800 mg doses were safe and well-tolerated through 28 days of treatment and displayed pharmacokinetics supportive of once-daily dosing. In viremic patients, treatment with EDP-514 resulted in mean HBV DNA reductions of 2.9, 3.3, and 3.5 logs at 28 days for the 200 mg, 400 mg, and 800 mg cohorts, respectively, compared to a 0.2 log reduction in the placebo group.
- Terminated development of EDP-721, an oral HBV RNA destabilizer due to adverse safety signals in a Phase 1 healthy volunteer study.
-
Respiratory Virology Discovery Initiatives: Enanta’s goal in the second half of 2021 is to identify one more clinical development candidate among the two discovery initiatives below:
-
RSV L-Protein Inhibitor
- On schedule to select a clinical candidate with potent nanomolar activity against both RSV-A and RSV-B by year-end.
-
Human Metapneumovirus (hMPV)
- Continuing lead optimization on potent nanomolar hMPV inhibitors.
-
RSV L-Protein Inhibitor
Non-Alcoholic Steatohepatitis (NASH)
- Announced a strategic decision to discontinue internal development of FXR agonists EDP-305 and EDP-297, to prioritize combination approaches for NASH through out-licensing.
Corporate
-
Announced the election of
Yujiro S. Hata to Enanta’s Board of Directors.
Upcoming Events and Presentations
-
Evercore HealthCONx,
November 30 –December 2, 2021 -
Piper Sandler 33rd Annual Healthcare Conference,
November 30 –December 2, 2021 -
40th Annual
JP Morgan Healthcare Conference ,January 10 – 13, 2022 -
Enanta plans to issue its fiscal 2022 first quarter results press release, and hold a conference call regarding those results, on
February 8, 2022 .
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at
About Enanta
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 currently in development for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and SARS-CoV-2 (COVID-19). 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 part of AbbVie’s leading treatment for chronic HCV infection that it sells in numerous countries under the tradenames MAVYRET® (
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta’s research and development programs in RSV, HBV, SARS-CoV-2 and hMPV, as well as future royalty revenue from sales of AbbVie’s MAVYRET/MAVIRET regimen for HCV. 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 dependence of Enanta’s revenues in the short-term upon the continued success of AbbVie’s sales of its MAVYRET/MAVIRET HCV regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, HBV, SARS-CoV-2 and hMPV; treatment rates, competitive pricing, and reimbursement rate actions affecting MAVYRET/MAVIRET compared to competitive HCV products on the market; any continuing impact of COVID-19 on AbbVie’s MAVYRET/MAVIRET sales; the discovery and development risks of Enanta’s research and development programs in RSV, HBV, SARS-CoV-2 and hMPV; 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; the realizability of our deferred tax assets; and other risk factors described or referred to in “Risk Factors” in Enanta’s most recent Form 10-Q for the quarter ended
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| UNAUDITED | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
Three Months Ended |
|
Twelve Months Ended |
||||||||||||||
|
|
|
||||||||||||||
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||||
| Revenue | $ |
23,575 |
|
$ |
23,631 |
|
$ |
97,074 |
|
$ |
122,473 |
|
||||
| Operating expenses | ||||||||||||||||
| Research and development |
|
48,946 |
|
|
36,686 |
|
|
174,111 |
|
|
136,756 |
|
||||
| General and administrative |
|
8,356 |
|
|
6,728 |
|
|
32,536 |
|
|
27,356 |
|
||||
| Total operating expenses |
|
57,302 |
|
|
43,414 |
|
|
206,647 |
|
|
164,112 |
|
||||
| Loss from operations |
|
(33,727 |
) |
|
(19,783 |
) |
|
(109,573 |
) |
|
(41,639 |
) |
||||
| Other income, net |
|
333 |
|
|
1,149 |
|
|
1,994 |
|
|
6,620 |
|
||||
| Loss before income taxes |
|
(33,394 |
) |
|
(18,634 |
) |
|
(107,579 |
) |
|
(35,019 |
) |
||||
| Income tax (expense) benefit |
|
8,795 |
|
|
(10,707 |
) |
|
28,583 |
|
|
(1,149 |
) |
||||
| Net loss | $ |
(24,599 |
) |
$ |
(29,341 |
) |
$ |
(78,996 |
) |
$ |
(36,168 |
) |
||||
| Net loss per share | ||||||||||||||||
| Basic | $ |
(1.22 |
) |
$ |
(1.46 |
) |
$ |
(3.92 |
) |
$ |
(1.81 |
) |
||||
| Diluted | $ |
(1.22 |
) |
$ |
(1.46 |
) |
$ |
(3.92 |
) |
$ |
(1.81 |
) |
||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic |
|
20,221 |
|
|
20,074 |
|
|
20,171 |
|
|
19,940 |
|
||||
| Diluted |
|
20,221 |
|
|
20,074 |
|
|
20,171 |
|
|
19,940 |
|
||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| UNAUDITED | ||||||
| (in thousands) | ||||||
|
|
|
||||
2021 |
|
2020 |
||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ |
57,206 |
$ |
87,131 |
||
| Short-term marketable securities |
|
186,796 |
|
299,518 |
||
| Accounts receivable |
|
23,576 |
|
23,492 |
||
| Prepaid expenses and other current assets |
|
14,188 |
|
13,655 |
||
| Income tax receivable |
|
37,255 |
|
13,041 |
||
| Total current assets |
|
319,021 |
|
436,837 |
||
| Long-term marketable securities |
|
108,416 |
|
32,634 |
||
| Property and equipment, net |
|
5,943 |
|
8,596 |
||
| Deferred tax assets |
|
— |
|
345 |
||
| Operating lease, right-of-use assets |
|
4,711 |
|
7,020 |
||
| Restricted cash |
|
608 |
|
608 |
||
| Other long-term assets |
|
92 |
|
92 |
||
| Total assets | $ |
438,791 |
$ |
486,132 |
||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities | ||||||
| Accounts payable | $ |
9,540 |
$ |
5,737 |
||
| Accrued expenses and other current liabilities |
|
22,429 |
|
14,159 |
||
| Operating lease liabilities |
|
4,203 |
|
4,261 |
||
| Total current liabilities |
|
36,172 |
|
24,157 |
||
| Operating lease liabilities, net of current portion |
|
1,126 |
|
3,838 |
||
| Series 1 nonconvertible preferred stock |
|
1,506 |
|
1,479 |
||
| Other long-term liabilities |
|
558 |
|
1,078 |
||
| Total liabilities |
|
39,362 |
|
30,552 |
||
| Total stockholders' equity |
|
399,429 |
|
455,580 |
||
| Total liabilities and stockholders' equity | $ |
438,791 |
$ |
486,132 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20211122006607/en/
Media and Investors:
Tel: 617-744-3848
jviera@enanta.com
Source:
FAQ
What were the financial results for Enanta Pharmaceuticals for the fiscal year 2021?
What is the status of Enanta's EDP-514 development?
What is the cash position of Enanta Pharmaceuticals?
What are the upcoming milestones for Enanta Pharmaceuticals?
What safety concerns led to the termination of EDP-721?
