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): May 06, 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.)
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:

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. ☐

 

---

Item 2.02 Results of Operations and Financial Condition.

On May 6, 2024, Enanta Pharmaceuticals, Inc. announced via press release its results for the fiscal quarter ended March 31, 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 May 6, 2024, reporting Enanta's financial results for the fiscal quarter ended March 31, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

---

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 6, 2024	By:	/s/ Paul J. Mellett
			Paul J. Mellett Chief Financial and Administrative Officer

 

---

Exhibit 99.1

 

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter with Webcast and Conference Call Today at 4:30 p.m. ET

 

WATERTOWN, Mass., May 6, 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 second quarter ended March 31, 2024.

“At Enanta, we are committed to advancing the first antiviral treatment for RSV, and more broadly developing important medicines in virology and immunology. Our commitment is highlighted by our goal to deliver multiple RSV data readouts this year, including from our challenge study of EDP-323, an oral L-protein inhibitor, expected in the third quarter, and from RSVPEDs, our Phase 2 pediatric study of zelicapavir, an oral N-protein inhibitor. In RSVPEDs, we are nearing study completion and are now only enrolling patients aged 28 days to 6 months, which is the last age cohort in Part 2. As this narrows the eligible patient population, we will continue recruiting in the Southern Hemisphere and anticipate reporting data from this study in the second half of 2024,” said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. “Pending positive data from these studies, we will be poised to deliver potential first-in-class antiviral replication inhibitors with differentiated mechanisms of action and advance our robust RSV portfolio. Beyond RSV, we are eager to help patients affected by CSU, a severely debilitating inflammatory skin disease, with our first immunology program focused on developing oral KIT inhibitors. We are on track to select a KIT inhibitor development candidate in the fourth quarter and look forward to expanding more broadly into immune-mediated chronic diseases with a second program this year.”

Fiscal Second Quarter Ended March 31, 2024 Financial Results

Total revenue for the three months ended March 31, 2024 was $17.1 million and consisted of royalty revenue from worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), compared to $17.8 million for the three months ended March 31, 2023.

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 from the royalty sale was $2.6 million for the three months ended March 31, 2024.

Research and development expenses totaled $35.6 million for the three months ended March 31, 2024, compared to $43.5 million for the three months ended March 31, 2023. The decrease was primarily due to a decrease in costs associated with Enanta’s COVID-19 program, as the company announced previously that plans to pursue any future COVID-19 efforts would be in the context of a collaboration. This decrease was partially offset by increased costs associated with Enanta’s RSV programs and its recently announced immunology programs.

General and administrative expenses totaled $14.2 million for the three months ended March 31, 2024, compared to $13.8 million for the three months ended March 31, 2023. The increase was primarily due to an increase in legal expenses related to the company’s patent infringement lawsuit against Pfizer.

Enanta recorded an income tax benefit of $0.4 million for the three months ended March 31, 2024, for interest earned on a pending $28.0 million federal income tax refund, compared to an income tax expense of less than $0.1 million for the three months ended March 31, 2023.

Net loss for the three months ended March 31, 2024 was $31.2 million, or a loss of $1.47 per diluted common share, compared to a net loss of $37.7 million, or a loss of $1.79 per diluted common share, for the corresponding period in 2023.

Enanta is updating its expense guidance at this fiscal year mid-point. Research and development expense is $125 million to $145 million. General and administrative expense is $50 million to $60 million. The research and development expense increase reflects the impact of the company’s new immunology programs as well as additional efforts to accelerate the RSV clinical studies. The general and administrative expense increase is due to additional stock compensation expense and costs associated with pursuing the company’s patent infringement lawsuit.

Enanta’s cash, cash equivalents and short-term marketable securities totaled $300.3 million at March 31, 2024. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its retained portion of future royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs through the third quarter of fiscal 2027.

Virology

RSV

---

Immunology

Corporate

---

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 at "Events & Presentations" in the investors section of Enanta’s website. To participate by phone, please register for the call here. It is recommended that participants register a minimum of 15 minutes before the call. Once registered, participants will receive an email with 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 with an emphasis on indications in virology and immunology. Enanta’s research and development programs are currently focused on respiratory syncytial virus (RSV) and chronic spontaneous urticaria (CSU) and the company has previously advanced clinical-stage compounds for SARS-CoV-2 (COVID-19) and chronic hepatitis B virus (HBV) infection.

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 program in CSU. 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 and CSU; 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

#

 

 

---

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,
			2024				2023				2024				2023
Revenue			$	17,054			$	17,795			$	35,057			$	41,380
Operating expenses
Research and development				35,585				43,468				71,956				84,370
General and administrative				14,235				13,778				30,753				26,474
Total operating expenses				49,820				57,246				102,709				110,844
Loss from operations				(32,766	)			(39,451	)			(67,652	)			(69,464	)
Interest expense				(2,563	)			—				(6,004	)			—
Interest and investment income, net				3,809				1,837				8,107				2,830
Loss before income taxes				(31,520	)			(37,614	)			(65,549	)			(66,634	)
Income tax benefit				363				(44	)			985				(10	)
Net loss			$	(31,157	)		$	(37,658	)		$	(64,564	)		$	(66,644	)
Net loss per share
	Basic		$	(1.47	)		$	(1.79	)		$	(3.06	)		$	(3.19	)
	Diluted		$	(1.47	)		$	(1.79	)		$	(3.06	)		$	(3.19	)
Weighted average common shares outstanding
	Basic			21,167				21,035				21,128				20,882
	Diluted			21,167				21,035				21,128				20,882

 

---

ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
				March 31,				September 30,
				2024				2023
Assets
Current assets
	Cash and cash equivalents			$	63,542			$	85,388
	Short-term marketable securities				236,768				284,522
	Accounts receivable				7,756				8,614
	Prepaid expenses and other current assets				10,932				13,263
	Income tax receivable				32,031				31,004
		Total current assets			351,029				422,791
Property and equipment, net					15,479				11,919
Operating lease, right-of-use assets					42,894				22,794
Restricted cash					3,968				3,968
Other long-term assets					187				803
		Total assets		$	413,557			$	462,275
Liabilities and Stockholders' Equity
Current liabilities
	Accounts payable			$	6,726			$	4,097
	Accrued expenses and other current liabilities				10,630				18,339
	Liability related to the sale of future royalties				33,671				35,076
	Operating lease liabilities				3,581				5,275
		Total current liabilities			54,608				62,787
Liability related to the sale of future royalties, net of current portion					147,776				159,429
Operating lease liabilities, net of current portion					43,412				21,238
Series 1 nonconvertible preferred stock					1,423				1,423
Other long-term liabilities					224				663
		Total liabilities			247,443				245,540
Total stockholders' equity					166,114				216,735
		Total liabilities and stockholders' equity		$	413,557			$	462,275

 

---

v3.24.1.u1

Document And Entity Information	May 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 06, 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	500 Arsenal Street
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
Entity Information, Former Legal or Registered Name	Not Applicable
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

---