ENTA Enanta Pharmaceuticals Inc

 

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): November 25, 2024

 

 

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.)
4 Kingsbury Avenue
Watertown, Massachusetts				02472
(Address of Principal Executive Offices)				(Zip Code)

 

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

 

500 Arsenal Street

Watertown, Massachusetts 02472

(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:

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 November 25, 2024, Enanta Pharmaceuticals, Inc. announced via press release its results for the fiscal quarter and year-ended September 30, 2024. 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 November 25, 2024, reporting Enanta's financial results for the fiscal quarter and year-ended September 30, 2024
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:	November 25, 2024	By:	/s/ Paul J. Mellett
			Paul J. Mellett Chief Financial and Administrative Officer

 

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Exhibit 99.1

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year-Ended September 30, 2024

 

WATERTOWN, Mass., November 25, 2024 – Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today reported financial results for its fiscal fourth quarter and year-ended September 30, 2024.

 

“Our fiscal fourth quarter was an exciting time for Enanta as we announced positive data from a Phase 2a human challenge study of EDP-323, our RSV L-inhibitor. We believe these results are among the strongest ever reported for an antiviral in an RSV challenge study, and significantly unlock further promise of our RSV program, in addition to advancing our leadership role in the RSV treatment landscape,” said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. “With results from our RSVPEDs study of zelicapavir, our RSV N-inhibitor, expected in December, we could potentially have two of the leading clinical candidates for the treatment of RSV with different mechanisms of action, providing us with important optionality. The results of these studies will guide our decisions as we work to develop first-in-disease and best-in-class treatments for patients suffering from RSV.”

 

Dr. Luly added, “We also made notable progress in advancing and expanding our immunology portfolio with the nomination of EPS-1421 as our lead development candidate for our KIT inhibition program. We are excited about the potential for potent and selective, oral, small molecule inhibitors for the treatment of chronic spontaneous urticaria and possibly other mast cell driven diseases. We are also pleased to introduce our second discovery stage program to develop oral STAT6 inhibitors for the treatment of type 2 immune driven diseases, with an initial focus on the treatment of atopic dermatitis, and future expansion opportunities in asthma and other indications. With multiple ongoing programs in both virology and immunology, we are committed to advancing our pipeline to help patients and to create value for shareholders.”

 

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Fiscal Fourth Quarter and Year-Ended September 30, 2024 Financial Results

Total revenue was $14.6 million for the three months ended September 30, 2024, which consisted of royalty revenue derived from worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®, compared to royalty revenue of $18.9 million for the three months ended September 30, 2023. For the twelve months ended September 30, 2024, total revenue was $67.6 million compared to $79.2 million for the same period in 2023. The decrease in the quarter and in year-over-year revenue is due to a decline in AbbVie’s sales of MAVYRET®/MAVIRET®.

 

A portion (54.5%) of Enanta’s ongoing royalty revenue from AbbVie’s net sales of MAVYRET®/MAVIRET® is paid to OMERS, one of Canada’s largest defined benefit pension plans, pursuant to a royalty sale transaction affecting royalties earned after June 2023. For financial reporting purposes, the transaction was treated as debt, with the upfront purchase payment of $200.0 million recorded as a liability. Each quarter, Enanta records 100% of the royalty earned as revenue and then amortizes the debt liability proportionally as 54.5% of the cash royalty payments are paid to OMERS through June 30, 2032, subject to a cap of 1.42 times the purchase payment, after which point 100% of the cash royalty payments will be retained by Enanta. Interest expense was $2.6 million for the three months ended September 30, 2024 and $10.9 million for the twelve months ended September 30, 2024. This compares to interest expense of $3.2 million for the three months ended September 30, 2023 and $5.1 million for the twelve months ended September 30, 2023.

 

Research and development expenses were $30.8 million for the three months ended September 30, 2024, compared to $36.2 million for the three months ended September 30, 2023. For the twelve months ended September 30, 2024, research and development expenses were $131.5 million compared to $163.5 million for the same period in 2023. The decrease in the quarter and in year-over-year research and development expenses is primarily due to a decrease in costs associated with Enanta’s COVID-19 program as the company announced previously that plans to pursue any further COVID-19 efforts would be in the context of collaborations. These decreases were partially offset by increased costs associated with Enanta’s immunology programs.

General and administrative expenses totaled $13.7 million for the three months ended September 30, 2024, compared to $13.8 million for the three months ended September 30, 2023. For the twelve months ended September 30, 2024, general and administrative expenses were $57.9 million compared to $52.9 million in 2023. The increase in year-over-year general and administrative expenses was due to an increase in legal fees related to the company’s patent infringement suit against Pfizer.

 

Interest and investment income, net, totaled $3.2 million for the three months ended September 30, 2024, compared to $4.7 million for the three months ended September 30, 2023. The decrease was due to lower cash and investment balances year-over-year. For the twelve months ended September 30, 2024, interest and investment income, net, totaled $14.8 million compared to $11.4 million in 2023. The increase was due to an increase in average invested cash due to receipt of $200.0 million from OMERS in April 2023 as well as changes in interest rates year-over-year.

 

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Enanta recorded an income tax benefit of $0.4 million for the three months ended September 30, 2024, compared to an income tax benefit of $1.4 million for the three months ended September 30, 2023. Enanta recorded an income tax benefit of $1.7 million for the twelve months ended September 30, 2024, compared to an income tax expense of $2.8 million for the twelve months ended September 30, 2023. The income tax benefit during 2024 was due to interest earned on a pending $28.7 million federal income tax refund. Despite recording a loss before taxes during the twelve months ended September 30, 2023, Enanta recorded tax expense driven by the receipt of the $200.0 million from OMERS, which is treated as income for Federal and State income tax purposes.

Net loss for the three months ended September 30, 2024, was $28.8 million, or a loss of $1.36 per diluted common share, compared to a net loss of $28.1 million, or a loss of $1.33 per diluted common share, for the corresponding period in 2023. For the twelve months ended September 30, 2024, net loss was $116.0 million, or a loss of $5.48 per diluted common share, compared to a net loss of $133.8 million, or loss of $6.38 per diluted common share for the corresponding period in 2023.

Enanta’s cash, cash equivalents and marketable securities totaled $248.2 million at September 30, 2024. Enanta expects that its current cash, cash equivalents and short-term marketable securities, as well as its continuing retained portion of royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of its existing business and development programs into fiscal 2027.

 

Virology

RSV

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Immunology

Corporate

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 with an emphasis on indications in virology

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and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition.

Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. 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 and its preclinical programs targeting KIT and STAT6 inhibition. 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; the discovery and development risks of Enanta’s programs in virology and immunology; 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, 2023, 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 Investors Contact:

Jennifer Viera

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								Twelve Months Ended
			September 30,								September 30,
			2024				2023				2024				2023
Revenue			$	14,607			$	18,932			$	67,635			$	79,204
Operating expenses
Research and development				30,778				36,167				131,476				163,524
General and administrative				13,683				13,795				57,850				52,887
Total operating expenses				44,461				49,962				189,326				216,411
Loss from operations				(29,854	)			(31,030	)			(121,691	)			(137,207	)
Interest expense				(2,581	)			(3,151	)			(10,940	)			(5,148	)
Interest and investment income, net				3,249				4,664				14,843				11,360
Loss before income taxes				(29,186	)			(29,517	)			(117,788	)			(130,995	)
Income tax benefit (expense)				363				1,410				1,743				(2,821	)
Net loss			$	(28,823	)		$	(28,107	)		$	(116,045	)		$	(133,816	)
Net loss per share
	Basic		$	(1.36	)		$	(1.33	)		$	(5.48	)		$	(6.38	)
	Diluted		$	(1.36	)		$	(1.33	)		$	(5.48	)		$	(6.38	)
Weighted average common shares outstanding
	Basic			21,190				21,057				21,157				20,969
	Diluted			21,190				21,057				21,157				20,969

 

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ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
				September 30,				September 30,
				2024				2023
Assets
Current assets
	Cash and cash equivalents			$	37,233			$	85,388
	Short-term marketable securities				210,953				284,522
	Accounts receivable				6,646				8,614
	Prepaid expenses and other current assets				12,413				13,263
	Income tax receivable				31,999				31,004
	Short-term restricted cash				608				—
		Total current assets			299,852				422,791
Property and equipment, net					32,688				11,919
Operating lease, right-of-use assets					40,658				22,794
Long-term restricted cash					3,360				3,968
Other long-term assets					94				803
		Total assets		$	376,652			$	462,275
Liabilities and Stockholders' Equity
Current liabilities
	Accounts payable			$	8,002			$	4,097
	Accrued expenses and other current liabilities				13,547				18,339
	Liability related to the sale of future royalties				34,462				35,076
	Operating lease liabilities				1,524				5,275
		Total current liabilities			57,535				62,787
Liability related to the sale of future royalties, net of current portion					134,779				159,429
Operating lease liabilities, net of current portion					53,943				21,238
Series 1 nonconvertible preferred stock					1,350				1,423
Other long-term liabilities					231				663
		Total liabilities			247,838				245,540
Total stockholders' equity					128,814				216,735
		Total liabilities and stockholders' equity		$	376,652			$	462,275

 

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v3.24.3

Document And Entity Information	Nov. 25, 2024
Document Information [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 25, 2024
Entity Registrant Name	ENANTA PHARMACEUTICALS, INC.
Entity Central Index Key	0001177648
Entity Emerging Growth Company	false
Entity File Number	001-35839
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	04-3205099
Entity Address, Address Line One	4 Kingsbury Avenue
Entity Address, City or Town	Watertown
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02472
City Area Code	(617)
Local Phone Number	607-0800
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	ENTA
Security Exchange Name	NASDAQ
Former Address [Member]
Document Information [Line Items]
Entity Address, Address Line One	500 Arsenal Street
Entity Address, City or Town	Watertown
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02472

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