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Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended

Key Takeaway: Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2019 Webcast and Conference Call today at 4:30 p.m. ET WATERTOWN, Mass., August 6, 2019 - Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology co

Full Press Release Details

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2019
Webcast and Conference Call today at 4:30 p.m. ET
WATERTOWN, Mass., August 6, 2019 - Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused 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, 2019.
"Enanta executed on key clinical milestones during the past few months, the most significant being the completion of a successful Phase 2a challenge study of EDP-938 for RSV. In addition, we recently initiated a Phase 1 study of EDP-514, our lead candidate for the treatment of HBV," commented Jay R. Luly, Ph.D., Enanta President and CEO. "Our pipeline is maturing, and we now have clinical studies ongoing with three compounds, all of which have been granted Fast Track designation."
Fiscal Third Quarter Ended June 30, 2019 Financial Results
Total revenue of $44.4 million for the three months ended June 30, 2019 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, 2018, total revenue was $57.3 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 2019 was mainly driven by lower treated patient volumes in select international markets.
Research and development expenses increased to $34.5 million for the three months ended June 30, 2019, compared to $28.5 million for the three months ended June 30, 2018, primarily due to increased clinical costs associated with the progression of Enanta's wholly-owned clinical programs in respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and hepatitis B virus (HBV).
General and administrative expenses totaled $6.2 million for the three months ended June 30, 2019, compared to $6.1 million for the three months ended June 30, 2018.
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Enanta recorded an income tax benefit of $0.9 million for the three months ended June 30, 2019 compared to income tax expense of $3.7 million for the same period in 2018. The income tax benefit was driven by a federal tax benefit associated with foreign derived royalty income from our AbbVie collaboration agreement.
Net income for the three months ended June 30, 2019 was $7.0 million, or $0.33 per diluted common share, compared to net income of $20.3 million, or $0.97 per diluted common share, for the corresponding period in 2018.
Enanta's cash, cash equivalents and marketable securities totaled $389.2 million at June 30, 2019. This compares to a total of $325.1 million at September 30, 2018. 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 the foreseeable future.
Development Programs and Business Review
EDP-938, N-Protein Inhibitor for Respiratory Syncytial Virus (RSV):
EDP-305, FXR Agonist for Non-Alcoholic Steatohepatitis (NASH):
EDP-514, Core Inhibitor for Hepatitis B Virus (HBV):
Hepatitis C Virus (HCV) collaboration with AbbVie:
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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 6, 2019, through 11:59 p.m. ET on August 8, 2019 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 6794018. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentation" 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 are currently focused on the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH)/ primary biliary cholangitis (PBC), and hepatitis B virus (HBV).
Enanta's research and development activities are funded by royalties from HCV products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is now sold by AbbVie in numerous countries as part of its newest treatment for chronic hepatitis C virus (HCV) infection. This leading HCV regimen is sold 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/PBC and HBV, as well as the prospects for 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, PBC and HBV; treatment rates, competitive pricing, and reimbursement rate actions affecting MAVYRET /MAVIRET compared to competitive HCV products on the market; the discovery and development risks of Enanta's programs in
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RSV, NASH, PBC, 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; 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, 2019, 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.
MacDougall Biomedical Communications
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ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except per share amounts)
Three Months Ended Nine Months Ended
June 30, June 30,
2019 2018 2019 2018
Revenue $ 44,367 $ 57,262 $ 153,884 $ 139,420
Operating expenses
Research and development 34,461 28,487 103,494 67,933
General and administrative 6,151 6,135 20,083 17,611
Total operating expenses 40,612 34,622 123,577 85,544
Income from operations 3,755 22,640 30,307 53,876
Other income, net 2,415 1,338 6,545 3,364
Income before income taxes 6,170 23,978 36,852 57,240
Income tax (expense) benefit 866 (3,690 ) 340 (12,704 )
Net income $ 7,036 $ 20,288 $ 37,192 $ 44,536
Net income per share
Basic $ 0.36 $ 1.05 $ 1.90 $ 2.32
Diluted $ 0.33 $ 0.97 $ 1.77 $ 2.17
Weighted average common shares outstanding
Basic 19,673 19,303 19,549 19,212
Diluted 21,105 21,017 20,999 20,509
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ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
June 30, September 30,
2019 2018
Assets
Current assets
Cash and cash equivalents $ 94,206 $ 63,902
Short-term marketable securities 295,042 244,828
Accounts receivable 44,367 67,205
Prepaid expenses and other current assets 17,647 4,454
Total current assets 451,262 380,389
Long-term marketable securities - 16,389
Property and equipment, net 11,373 8,374
Deferred tax assets 10,149 8,375
Restricted cash 608 608
Other long-term assets 92 92
Total assets $ 473,484 $ 414,227
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable $ 6,504 $ 4,745
Accrued expenses and other current liabilities 13,997 9,892
Income taxes payable - 1,388
Total current liabilities 20,501 16,025
Series 1 nonconvertible preferred stock 1,628 1,628
Other long-term liabilities 3,258 2,895
Total liabilities 25,387 20,548
Total stockholders' equity 448,097 393,679
Total liabilities and stockholders' equity $ 473,484 $ 414,227
Last updated: Aug 6, 2019