ENTA 8-K
Enanta Pharmaceuticals Inc (ENTA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(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:
|
|
Trading |
|
|
|
|
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 8, 2023, Enanta Pharmaceuticals, Inc. announced via press release its results for the fiscal quarter March 31, 2023. 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 |
|
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 8, 2023 |
By: |
/s/ Paul J. Mellett |
|
|
|
Paul J. Mellett |
Exhibit 99.1
Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter with Conference Call and Webcast Today at 4:30 p.m. ET
WATERTOWN, Mass., May 8, 2023 – 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 second quarter ended March 31, 2023.
“At Enanta, we are focused on transforming the lives of patients with curative therapies, by leveraging our previous successes in the development of small molecules and our deep understanding of virologic diseases,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “This vision is supported by positive topline data from our SPRINT Phase 2 study announced today. With EDP-235 and Enanta’s entire pipeline, our goal continues to be to develop cures for life-threatening viral infections. Looking ahead, we are also eager to advance our programs in respiratory syncytial virus with an upcoming data readout for EDP-323, our L-protein inhibitor in development as a once-daily oral treatment, next month. Further, the financial flexibility we now have with the additional funding from our royalty monetization allows us to continue to advance our robust pipeline.”
Fiscal Second Quarter Ended March 31, 2023 Financial Results
Total revenue for the three months ended March 31, 2023 was $17.8 million and consisted of royalty revenue from worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), compared to $18.7 million for the three months ended March 31, 2022.
Research and development expenses totaled $43.5 million for the three months ended March 31, 2023, compared to $42.1 million for the three months ended March 31, 2022. The increase was primarily due to the timing of clinical trial expenses in our virology programs.
General and administrative expenses totaled $13.8 million for the three months ended March 31, 2023, compared to $10.5 million for the three months ended March 31, 2022. The increase was due to increased stock-related compensation expense and legal fees associated with our patent infringement suit against Pfizer.
Net loss for the three months ended March 31, 2023 was $37.7 million, or a loss of $1.79 per diluted common share, compared to a net loss of $33.6 million, or a loss of $1.63 per diluted common share, for the corresponding period in 2022.
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled $225.1 million at March 31, 2023, before giving effect to its April 2023 sale of 54.5% of its ongoing MAVYRET®/MAVIRET® royalties from AbbVie for an upfront payment of $200 million from OMERS, one of Canada’s largest defined benefit pension plans. Enanta expects that its current cash, cash equivalents and marketable securities, as well as the royalty sale and Enanta’s continuing portion of cash from future royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs into calendar 2026.
Pipeline Updates
COVID-19 (SARS-CoV-2)
Respiratory Syncytial Virus (RSV)
Human Metapneumovirus (hMPV)/RSV
Hepatitis B Virus (HBV)
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 under "Events & Presentations" in the investors section of Enanta’s website. To join by phone, participants can 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 for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus (hMPV).
Enanta receives 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 dual-inhibitor program in hMPV/RSV. 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 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-K for the fiscal year ended September 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.
Media and Investors Contact:
Jennifer Viera
617-744-3848
#
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
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, |
|
||||||||||
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue |
$ |
17,795 |
|
|
$ |
18,716 |
|
|
$ |
41,380 |
|
|
$ |
46,364 |
|
||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development |
|
43,468 |
|
|
|
42,087 |
|
|
|
84,370 |
|
|
|
90,636 |
|
||
General and administrative |
|
13,778 |
|
|
|
10,476 |
|
|
|
26,474 |
|
|
|
19,984 |
|
||
Total Operating expenses |
|
57,246 |
|
|
|
52,563 |
|
|
|
110,844 |
|
|
|
110,620 |
|
||
Loss from operations |
|
(39,451 |
) |
|
|
(33,847 |
) |
|
|
(69,464 |
) |
|
|
(64,256 |
) |
||
Other income, net |
|
1,837 |
|
|
|
255 |
|
|
|
2,830 |
|
|
|
549 |
|
||
Loss before income taxes |
|
(37,614 |
) |
|
|
(33,592 |
) |
|
|
(66,634 |
) |
|
|
(63,707 |
) |
||
Income tax expense |
|
(44 |
) |
|
|
- |
|
|
|
(10 |
) |
|
|
- |
|
||
Net loss |
$ |
(37,658 |
) |
|
$ |
(33,592 |
) |
|
$ |
(66,644 |
) |
|
$ |
(63,707 |
) |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share |
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic |
$ |
(1.79 |
) |
|
$ |
(1.63 |
) |
|
$ |
(3.19 |
) |
|
$ |
(3.11 |
) |
|
|
Diluted |
$ |
(1.79 |
) |
|
$ |
(1.63 |
) |
|
$ |
(3.19 |
) |
|
$ |
(3.11 |
) |
|
Weighted average common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic |
|
21,035 |
|
|
|
20,551 |
|
|
|
20,882 |
|
|
|
20,473 |
|
|
|
Diluted |
|
21,035 |
|
|
|
20,551 |
|
|
|
20,882 |
|
|
|
20,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
ENANTA PHARMACEUTICALS, INC. |
|
|||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|||||||||
UNAUDITED |
|
|||||||||
(in thousands) |
|
|||||||||
|
|
|
|
|
|
|
|
|
||
|
|
|
|
March 31, |
|
|
September 30, |
|
||
|
|
|
|
2023 |
|
|
2022 |
|
||
Assets |
|
|
|
|
|
|||||
Current assets |
|
|
|
|
|
|||||
|
Cash and cash equivalents |
$ |
73,178 |
|
|
$ |
43,994 |
|
||
|
Short-term marketable securities |
|
136,906 |
|
|
|
205,238 |
|
||
|
Accounts receivable |
|
17,795 |
|
|
|
20,318 |
|
||
|
Prepaid expenses and other current assets |
|
14,484 |
|
|
|
13,445 |
|
||
|
Income tax receivable |
|
28,774 |
|
|
|
28,718 |
|
||
|
|
Total current assets |
|
271,137 |
|
|
|
311,713 |
|
|
Long-term marketable securities |
|
15,040 |
|
|
|
29,285 |
|
|||
Property and equipment, net |
|
11,050 |
|
|
|
6,173 |
|
|||
Operating lease, right-of-use assets |
|
24,554 |
|
|
|
23,575 |
|
|||
Restricted cash |
|
3,968 |
|
|
|
3,968 |
|
|||
Other long-term assets |
|
696 |
|
|
|
696 |
|
|||
|
|
Total assets |
$ |
326,445 |
|
|
$ |
375,410 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|||||
Current liabilities |
|
|
|
|
|
|||||
|
Accounts payable |
$ |
11,761 |
|
|
$ |
6,000 |
|
||
|
Accrued expenses and other current liabilities |
|
15,482 |
|
|
|
20,936 |
|
||
|
Operating lease liabilities |
|
4,923 |
|
|
|
2,891 |
|
||
|
|
Total current liabilities |
|
32,166 |
|
|
|
29,827 |
|
|
Operating lease liabilities, net of current portion |
|
23,073 |
|
|
|
22,372 |
|
|||
Series 1 nonconvertible preferred stock |
|
1,423 |
|
|
|
1,423 |
|
|||
Other long-term liabilities |
|
408 |
|
|
|
454 |
|
|||
|
|
Total liabilities |
|
57,070 |
|
|
|
54,076 |
|
|
Total stockholders' equity |
|
269,375 |
|
|
|
321,334 |
|
|||
|
|
Total liabilities and stockholders' equity |
$ |
326,445 |
|
|
$ |
375,410 |
|
|
|
|
|
|
|
|
|
|
|
||