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Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year Ended September 30, 2022 With Webcast and Conference Call Today at 4:30 p.m. ET

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today reported financial results for its fiscal fourth quarter and year ended September 30, 2022.

“Our fiscal 2022 was a year of progress toward our vision of transforming the lives of patients with curative therapies, and in the past two months alone we began three new clinical trials to advance our pipeline,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “Most recently, the initiation of SPRINT, a Phase 2 study of EDP-235, our lead 3CL protease inhibitor, moves us further in developing a best-in-class treatment for COVID-19 without ritonavir boosting and associated drug-drug interactions. As new variants emerge that can evade immunity arising from vaccination or previous infection, EDP-235 has the potential to fill the need for rapid treatment of COVID infection as a once-daily, oral treatment. This quarter, we also expanded our RSV clinical program with the initiation of RSVHR, a Phase 2 study of EDP-938 in patients who are at high risk of complications, a population where we believe that treatment with EDP-938 has significant potential to show optimal efficacy and clinical benefit. Additionally, we dosed our first subject with EDP-323, our novel, oral therapeutic targeting the RSV L-protein RNA polymerase. The further progression of our clinical studies and expansion of our pipeline continues to enhance our robust position in respiratory virology.”

Fiscal Fourth Quarter and Year Ended September 30, 2022 Financial Results

Total revenue of $20.3 million for the three months ended September 30, 2022, consisted of royalty revenue derived from worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®, compared to royalty revenue of $23.6 million for the three months ended September 30, 2021. For the twelve months ended September 30, 2022, total revenue was $86.2 million compared to $97.1 million for the same period in 2021.

Research and development expenses were $34.8 million for the three months ended September 30, 2022, compared to $48.9 million for the three months ended September 30, 2021. For the twelve months ended September 30, 2022, research and development expenses were $164.5 million compared to $174.1 million in 2021. The decreases in both periods were due to the timing and scope of the company’s clinical trials.

General and administrative expenses totaled $12.6 million for the three months ended September 30, 2022, compared to $8.4 million for the three months ended September 30, 2021. For the twelve months ended September 30, 2022, general and administrative expenses were $45.5 million compared to $32.5 million in 2021. The increases in both periods were due primarily to additional headcount and stock compensation expense.

Enanta recorded an income tax expense of $0.01 million for the three months ended September 30, 2022, and an income tax benefit of $0.4 million for the twelve months ended September 30, 2022, which are due primarily to the release of a state tax reserve. Enanta recorded an income tax benefit of $8.8 million and $28.6 million for the three and twelve months ended September 30, 2021, respectively, due primarily to a federal net loss carryback available in fiscal 2021 under the CARES Act of 2020. Enanta is still due a refund of $28.7 million for the tax losses carried back in 2021 to offset taxable income in prior years.

Net loss for the three months ended September 30, 2022, was $26.3 million, or a loss of $1.27 per diluted common share, compared to a net loss of $24.6 million, or a loss of $1.22 per diluted common share, for the corresponding period in 2021. For the twelve months ended September 30, 2022, net loss was $121.8 million, or a loss of $5.91 per diluted common share, compared to a net loss of $79.0 million, or loss of $3.92 per diluted common share for the corresponding period in 2021.

Enanta’s cash, cash equivalents and marketable securities totaled $278.5 million at September 30, 2022. Enanta expects that its current cash, cash equivalents and short-term and long-term marketable securities, as well as its continuing royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of its existing business and development programs into the fourth quarter of fiscal 2024.

Financial Guidance for Fiscal Year 2023

Pipeline Programs

COVID-19 (SARS-CoV-2)

RSV

Human Metapneumovirus (hMPV)

Hepatitis B Virus (HBV)

Upcoming Events and Presentations

Conference Call and Webcast Information

Enanta will host a conference call and webcast today at 4:30 p.m. ET. The live webcast can be accessed under “Events & Presentations” in the investors section of Enanta’s website https://ir.enanta.com/events-presentations or by clicking here. To participate by phone, please register for the call here. It is recommended that participants register a day in advance or at a minimum of 15 minutes before the call. Once registered, participants will receive the dial-in information. The archived webcast will be available on Enanta’s website for approximately 30 days following the event.

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. Enanta’s research and development programs include clinical candidates 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 part of one of the leading treatment regimens for curing chronic HCV infection and is sold by AbbVie in numerous countries 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 vaccines and 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-Q for the fiscal quarter ended June 30, 2022, 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.

Tables to Follow

ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except per share amounts)
 

Three Months Ended

 

Twelve Months Ended

September 30,

 

September 30,

2022

 

2021

 

2022

 

2021

 
Revenue

$

20,317

 

$

23,575

 

$

86,160

 

$

97,074

 

Operating expenses
Research and development

 

34,796

 

 

48,946

 

 

164,522

 

 

174,111

 

General and administrative

 

12,569

 

 

8,356

 

 

45,482

 

 

32,536

 

Total operating expenses

 

47,365

 

 

57,302

 

 

210,004

 

 

206,647

 

Loss from operations

 

(27,048

)

 

(33,727

)

 

(123,844

)

 

(109,573

)

Other income, net

 

714

 

 

333

 

 

1,656

 

 

1,994

 

Loss before income taxes

 

(26,334

)

 

(33,394

)

 

(122,188

)

 

(107,579

)

Income tax benefit (expense)

 

(14

)

 

8,795

 

 

433

 

 

28,583

 

Net loss

$

(26,348

)

$

(24,599

)

$

(121,755

)

$

(78,996

)

Net loss per share
Basic

$

(1.27

)

$

(1.22

)

$

(5.91

)

$

(3.92

)

Diluted

$

(1.27

)

$

(1.22

)

$

(5.91

)

$

(3.92

)

Weighted average common shares outstanding
Basic

 

20,755

 

 

20,221

 

 

20,603

 

 

20,171

 

Diluted

 

20,755

 

 

20,221

 

 

20,603

 

 

20,171

 

ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
 

September 30,

 

September 30,

2022

 

2021

Assets
Current assets
Cash and cash equivalents

$

43,994

$

57,206

Short-term marketable securities

 

205,238

 

186,796

Accounts receivable

 

20,318

 

23,576

Prepaid expenses and other current assets

 

13,445

 

14,188

Income tax receivable

 

28,718

 

37,255

Total current assets

 

311,713

 

319,021

Long-term marketable securities

 

29,285

 

108,416

Property and equipment, net

 

6,173

 

5,943

Operating lease, right-of-use assets

 

23,575

 

4,711

Restricted cash

 

3,968

 

608

Other long-term assets

 

696

 

92

Total assets

$

375,410

$

438,791

Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable

$

6,000

$

9,540

Accrued expenses and other current liabilities

 

20,936

 

22,429

Operating lease liabilities

 

2,891

 

4,203

Total current liabilities

 

29,827

 

36,172

Operating lease liabilities, net of current portion

 

22,372

 

1,126

Series 1 nonconvertible preferred stock

 

1,423

 

1,506

Other long-term liabilities

 

454

 

558

Total liabilities

 

54,076

 

39,362

Total stockholders’ equity

 

321,334

 

399,429

Total liabilities and stockholders’ equity

$

375,410

$

438,791

 

Contacts

Media and Investor Contact:
Jennifer Viera

617-744-3848

jviera@enanta.com

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