false 0001177648 0001177648 2020-08-04 2020-08-04

 

 

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): August 4, 2020

 

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, including 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		ENTA		NASDAQ

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 August 4, 2020, Enanta Pharmaceuticals, Inc. announced via press release its results for the fiscal quarter ended June 30, 2020. 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.

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release of Enanta Pharmaceuticals, Inc. dated August 4, 2020, reporting Enanta’s financial results for the fiscal quarter ended June 30, 2020
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

1

---

 

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: August 4, 2020		By:	/s/ Paul J. Mellett
			Paul J. Mellett
			Senior Vice President, Finance and Administration and Chief Financial Officer

 

2

Exhibit 99.1

 

For Immediate Release

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2020 with Webcast and Conference Call Today at 4:30 p.m. ET

WATERTOWN, Mass., August 4, 2020 – 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 third quarter ended June 30, 2020.

“During the past quarter, Enanta made progress in our clinical development programs, laying the groundwork for several catalyst-rich quarters to come. Our virology programs, developed from years of antiviral drug discovery expertise, continue to advance with the initiation of our Phase 1b clinical trial in viremic HBV patients and the resumption of our Phase 1b study in HBV patients currently treated with nucleos(t)ide reverse transcriptase inhibitors, which was previously paused due to the COVID-19 pandemic,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “In addition, our Phase 2b RSVP trial in RSV is ongoing, and we are on schedule to initiate two additional studies for the condition, one in pediatric patients and a second in adult transplant patients, by year end. Finally, we are also excited about advancing our candidates in NASH this quarter, starting with the initiation of the ARGON-2 trial of EDP-305, our potent FXR agonist candidate, and the planned initiation later this quarter of the Phase 1 study of EDP-297, our highly potent and targeted follow-on FXR agonist.”

Fiscal Third Quarter Ended June 30, 2020 Financial Results

Total revenue of $18.7 million for the three months ended June 30, 2020 consisted of royalty revenue derived primarily from worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen

 

 

---

MAVYRET®/MAVIRET®. For the three months ended June 30, 2019, total revenue was $44.4 million, which consisted of royalty revenue earned on AbbVie’s global net sales of its HCV regimens. AbbVie has stated that the decrease in royalty revenue in the three months ended June 30, 2020 was mainly driven by declining treated patient volumes due to the COVID-19 pandemic.

Research and development expenses increased slightly to $34.7 million for the three months ended June 30, 2020, compared to $34.5 million for the three months ended June 30, 2019.

General and administrative expenses totaled $6.8 million for the three months ended June 30, 2020, compared to $6.2 million for the three months ended June 30, 2019. The slight increase was due to an increase in compensation expense.

Enanta recorded an income tax benefit of $7.1 million for the three months ended June 30, 2020 compared to an income tax benefit of $0.9 million for the same period in 2019. The income tax benefit in 2020 was driven by the company’s net loss for the period, federal research and development tax credits, and a federal net operating loss carry back.

Net loss for the three months ended June 30, 2020 was $14.3 million, or a loss of $0.71 per diluted common share, compared to net income of $7.0 million, or $0.33 per diluted common share, for the corresponding period in 2019.

Enanta’s cash, cash equivalents and marketable securities totaled $435.4 million at June 30, 2020. This compares to a total of $400.2 million at September 30, 2019, its fiscal year end. 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 for the foreseeable future.

Pipeline Programs and Near-term Milestones

 

 

---

 

 

 

Upcoming Events and Presentations

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 (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on August 4, 2020, through 11:59 p.m. ET on August 6, 2020 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 7561838. 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 efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).  

 

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, NASH and HBV, as well as the prospects for advancing research in hMPV and SARS-CoV-2 and future royalty revenue to Enanta 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, NASH, HBV, hMPV and SARS-CoV-2; treatment rates, competitive pricing, and reimbursement rate actions affecting MAVYRET/MAVIRET compared to competitive HCV products on the market; the impact COVID-19 could have on number of patient treatments which could impact MAVYRET/MAVIRET sales; the discovery and development risks of Enanta’s programs in RSV, NASH and HBV; 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 March 31, 2020, and 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

Tel: 617-744-3848

jviera@enanta.com

 

###

 

 

---

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

---