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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 09, 2022

 

 

ENANTA PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-35839	04-3205099
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
500 Arsenal Street
Watertown, Massachusetts				02472
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (617) 607-0800

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.01 per share		ENTA		NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On May 9, 2022, Enanta Pharmaceuticals, Inc. announced via press release its results for the fiscal quarter March 31, 2022. A copy of Enanta's press release is hereby furnished to the Commission and incorporated by reference herein as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

Exhibit Number	Description
99.1	Press Release of Enanta Pharmaceuticals, Inc. dated May 9, 2022, reporting Enanta's financial results for the fiscal quarter ended March 31, 2022
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			ENANTA PHARMACEUTICALS, INC.
Date:	May 9, 2022	By:	/s/ Paul J. Mellett
			Paul J. Mellett Senior Vice President, Finance and Administration and Chief Financial Officer

 

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Exhibit 99.1

 

 

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2022 With Webcast and Conference Call Today at 4:30 p.m. ET

 

WATERTOWN, Mass., May 9, 2022 – 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, 2022.

 

“We had a strong start to 2022, making meaningful strides to advance our leadership in the development of therapeutics for viral infections with important progress in our broad pipeline, most notably in our clinical stage RSV and COVID-19 programs,” said Jay R. Luly Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “The progress we made lays the groundwork for an important quarter to come, particularly as we soon approach significant inflection points. During this quarter, we expect to report topline data from our RSVP study, a Phase 2b trial designed to confirm the results of the challenge study, in the setting of community-acquired RSV infection in an otherwise healthy adult population. We are also on track to announce preliminary data from our COVID-19 Phase 1 study of EDP 235 this quarter which, if positive, will allow us to move to the next phase of clinical development in the second half of this year. Additionally, we plan to initiate a Phase 2b study in adults at high-risk for serious RSV infection by year end. With much to look forward to in the coming months, we are excited to continue to advance our mission of transforming the lives of patients by developing curative therapies for viral diseases that have a global impact and high unmet need.”

 

Fiscal Second Quarter Ended March 31, 2022 Financial Results

Total revenue for the three months ended March 31, 2022 was $18.7 million and consisted of royalty revenue derived primarily from worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), as treated patient volumes remain suppressed compared to pre-COVID levels. For the three months ended March 31, 2021, total revenue from royalties on AbbVie’s net sales of HCV regimens was $20.1 million.

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Research and development expenses totaled $42.1 million for the three months ended March 31, 2022, compared to $41.5 million for the three months ended March 31, 2021. The increase was driven by the timing of manufacturing and clinical trial costs associated with the company’s virology and liver disease programs.

 

General and administrative expenses totaled $10.5 million for the three months ended March 31, 2022, compared to $8.3 million for the three months ended March 31, 2021. The increase in general and administrative expenses was due to increased headcount and stock-related compensation expense.

 

Enanta recorded no income tax expense for the three months ended March 31, 2022, compared to an income tax benefit of $7.1 million for the same period of 2021. Enanta recorded an income tax benefit in 2021 due to the provision of the CARES Act of 2020, which enabled the company to carry back its tax loss in the 2021 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 March 31, 2022 was $33.6 million, or a loss of $1.63 per diluted common share, compared to a net loss of $22.0 million, or a loss of $1.09 per diluted common share, for the corresponding period in 2021.

 

Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled $322.5 million at March 31, 2022. 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

 

RSV

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COVID-19 (SARS-CoV-2)

 

Hepatitis B Virus (HBV)

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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 March 9, 2022, through 11:59 p.m. ET on March 16, 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 7061969. 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

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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-Q for the fiscal quarter ended December 31, 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.

 

Media and Investor Contact:

Jennifer Viera

617-744-3848

jviera@enanta.com

 

 

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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,
			2022				2021				2022				2021
Revenue			$	18,716			$	20,132			$	46,364			$	51,875
Operating expenses
Research and development				42,087				41,506				90,636				78,171
General and administrative				10,476				8,326				19,984				15,703
Total Operating expenses				52,563				49,832				110,620				93,874
Loss from operations				(33,847	)			(29,700	)			(64,256	)			(41,999	)
Other income, net				255				545				549				1,222
Loss before income taxes				(33,592	)			(29,155	)			(63,707	)			(40,777	)
Income tax benefit				—				7,110				—				10,404
Net loss			$	(33,592	)		$	(22,045	)		$	(63,707	)		$	(30,373	)
Net loss per share
	Basic		$	(1.63	)		$	(1.09	)		$	(3.11	)		$	(1.51	)
	Diluted		$	(1.63	)		$	(1.09	)		$	(3.11	)		$	(1.51	)
Weighted average common shares outstanding
	Basic			20,551				20,171				20,473				20,131
	Diluted			20,551				20,171				20,473				20,131

 

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ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
				March 31,				September 30,
				2022				2021
Assets
Current assets
	Cash and cash equivalents			$	40,989			$	57,206
	Short-term marketable securities				239,338				186,796
	Accounts receivable				18,716				23,576
	Prepaid expenses and other current assets				14,078				14,188
	Income tax receivable				28,748				37,255
		Total current assets			341,869				319,021
Long-term marketable securities					42,218				108,416
Property and equipment, net					4,815				5,943
Operating lease, right-of-use assets					17,216				4,711
Restricted cash					608				608
Other long-term assets					92				92
		Total assets		$	406,818			$	438,791
Liabilities and Stockholders' Equity
Current liabilities
	Accounts payable			$	5,985			$	9,540
	Accrued expenses and other current liabilities				21,740				22,429
	Operating lease liabilities				3,013				4,203
		Total current liabilities			30,738				36,172
Operating lease liabilities, net of current portion					15,115				1,126
Series 1 nonconvertible preferred stock					1,506				1,506
Other long-term liabilities					876				558
		Total liabilities			48,235				39,362
Total stockholders' equity					358,583				399,429
		Total liabilities and stockholders' equity		$	406,818			$	438,791

 

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