Full Press Release Details
Enanta Pharmaceuticals Reports Financial Results for its
Fiscal Third Quarter Ended June 30, 2015
Conference Call and Webcast Today at 4:30 p.m. ET
WATERTOWN, Mass., August 6, 2015 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, 2015.
Fiscal Third Quarter Ended June 30, 2015 Financial Results
Cash, cash equivalents and short-term and long-term marketable securities totaled $212 million at June 30, 2015. This compares to a total of $132 million
in such accounts at September 30, 2014. Enanta expects that its current cash, cash equivalents and marketable securities will be sufficient to meet the anticipated cash requirements of its existing business for the foreseeable future.
Revenue for the three months ended June 30, 2015 was $11.6 million, compared to $42.1 million for the three months ended June 30, 2014. For the 2015
quarter, revenue consisted primarily of royalties earned on a contractually specified portion of AbbVie s worldwide net sales of hepatitis C virus (HCV) treatment regimens containing paritaprevir, Enanta s lead protease inhibitor
identified within the ongoing AbbVie-Enanta collaboration. The higher revenue in the comparable quarter in 2014, when Enanta had no royalty revenue, consisted primarily of milestone payments from AbbVie totaling $40 million related to regulatory
filings in the U.S. and EU. For the nine months ended June 30, 2015, revenue was $146.5 million, compared to revenue of $45.1 million for the same period in 2014. The increase in revenue for the nine months ended June 30, 2015 was due
primarily to a total of $125 million in payments earned from AbbVie for the achievement of U.S. and EU commercialization regulatory approvals of VIEKIRA PAK and VIEKIRAX , respectively,
as well as to royalties earned on those products. Milestone payments, royalties and other payments from collaborations have varied significantly from period to period, and are expected to continue to do so.
Research and development expenses totaled $6.3 million for the three months ended June 30, 2015, compared to $4.6 million for the three months ended
June 30, 2014. For the nine months ended June 30, 2015, research and development expenses were $16.1 million, compared to $13.5 million for the same period in 2014. The increases in the three and nine month periods over the prior year
periods were primarily due to increased spending on Enanta s proprietary research programs.
General and administrative expenses totaled $3.6 million for the three months ended June 30, 2015, compared
to $2.6 million for the three months ended June 30, 2014. For the nine months ended June 30, 2015, general and administrative expenses totaled $9.9 million, compared to $7.3 million for the same period in 2014. The increases in the three
and nine month periods primarily reflected increases in stock-based compensation expense, due principally to increases in Enanta s stock price, as well as additional expenses incurred as Enanta expands its operations.
Net income for the three months ended June 30, 2015 was $2.4 million, or $0.13 per diluted common share, compared to $50.1 million, or $2.61 per diluted
common share, for the corresponding period in 2014. The net income in the 2014 quarter reflected not only a total of $40 million in milestone payments for regulatory filings, but also the reversal of the entire valuation allowance related to
Enanta s deferred tax assets, which resulted in an income tax benefit of $15.1 million in the quarter. For the nine months ended June 30, 2015, net income was $73.2 million, compared to $39.5 million for the same period in 2014. The
increase in net income during the nine month period ended June 30, 2015 was primarily due to $125 million in milestone payments received, as well as royalty revenue earned and payable, from AbbVie.
Enanta has a solid financial base from milestone payments received and royalty revenues being earned on AbbVie s net sales of paritaprevir,
commented Jay R. Luly, Ph.D., President and Chief Executive Officer. We will use these revenues to sustain our business operations, and advance our wholly-owned, proprietary programs in HCV and NASH, among others.
Development Program and Business Review
Upcoming Events and Presentations
Conference Call and Webcast Information
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 6:30 p.m. Eastern time on August 6, 2015, through 11:59 p.m. Eastern time on August 12, 2015 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 82580357. A live audio webcast of the call and replay can be accessed by visiting the Calendar of Events section on the Investors page of Enanta s website at www.enanta.com.
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases. Enanta has developed novel protease and NS5A inhibitors
that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). Enanta s protease inhibitors partnered with AbbVie include paritaprevir, which is contained in AbbVie s marketed
DAA regimens for HCV. Enanta also has a program to develop a host-targeted antiviral (HTA) inhibitor class for HCV targeted against cyclophilin, as well as another DAA program to develop nucleotide polymerase inhibitors. In addition, Enanta has a
preclinical program in non-alcoholic steatohepatitis, or NASH, which is a condition that results in liver inflammation and liver damage caused by a buildup of fat in the liver.
Forward Looking Statements Disclaimer
contains forward-looking statements, including statements with respect to the prospects for regulatory approval in Japan for AbbVie s HCV treatment regimen containing paritaprevir, the prospects for AbbVie s development of a
next-generation regimen containing ABT-493, the prospects for advancement of the NASH development program, expectations for a commercialization regulatory approval milestone payment for Japan, the likely level of Enanta royalties on AbbVie s
future net sales of paritaprevir-containing regimens, and the projected sufficiency of Enanta s cash-equivalent resources and marketable securities. 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: Enanta s revenues are dependent upon the success of AbbVie s planned regulatory approval and commercialization efforts for
its treatment regimens containing paritaprevir; Enanta s longer term revenues will likely be dependent upon the success of AbbVie s planned clinical development and commercialization of next-generation regimens containing ABT-493;
regulatory actions affecting further approvals of treatment regimens containing paritaprevir or any approval of a treatment regimen containing ABT-493; the pricing, market acceptance and reimbursement rates of treatment regimens containing
paritaprevir or ABT-493 compared to competitive HCV products on the market and product candidates of other companies under development; the discovery and development risks of early stage discovery efforts in new disease areas; potential competition
from the development efforts of others in those new disease areas; Enanta s lack of clinical development experience; Enanta s need to attract and retain senior management and key scientific 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-K
for the fiscal year ended September 30, 2014 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.
ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenue | $ | 11,599 | $ | 42,051 | $ | 146,464 | $ | 45,104 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 6,253 | 4,553 | 16,140 | 13,538 | ||||||||||||
| General and administrative | 3,643 | 2,603 | 9,850 | 7,255 | ||||||||||||
| Total operating expenses | 9,896 | 7,156 | 25,990 | 20,793 | ||||||||||||
| Income from operations | 1,703 | 34,895 | 120,474 | 24,311 | ||||||||||||
| Other income, net | 287 | 36 | 798 | 47 | ||||||||||||
| Income before income taxes | 1,990 | 34,931 | 121,272 | 24,358 | ||||||||||||
| Income tax (expense) benefit | 428 | 15,122 | (48,092 | ) | 15,122 | |||||||||||
| Net income | $ | 2,418 | $ | 50,053 | $ | 73,180 | $ | 39,480 | ||||||||
| Net income per share | ||||||||||||||||
| Basic | $ | 0.13 | $ | 2.70 | $ | 3.92 | $ | 2.16 | ||||||||
| Diluted | $ | 0.13 | $ | 2.61 | $ | 3.80 | $ | 2.06 | ||||||||
| Weighted average common shares outstanding | ||||||||||||||||
| Basic | 18,697,104 | 18,528,833 | 18,659,742 | 18,275,831 | ||||||||||||
| Diluted | 19,277,966 | 19,203,270 | 19,276,767 | 19,168,368 |
ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | September 30, | |||||||
| 2015 | 2014 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 19,844 | $ | 30,699 | ||||
| Short-term marketable securities | 134,442 | 60,065 | ||||||
| Accounts receivable | 11,724 | 1,724 | ||||||
| Unbilled receivables | 1,376 | 2,770 | ||||||
| Deferred tax assets | 1,757 | 11,123 | ||||||
| Prepaid expenses and other current assets | 3,497 | 1,594 | ||||||
| Total current assets | 172,640 | 107,975 | ||||||
| Property and equipment, net | 2,582 | 1,803 | ||||||
| Long-term marketable securities | 57,657 | 41,003 | ||||||
| Deferred tax assets | 4,287 | 4,198 | ||||||
| Restricted cash | 608 | 436 | ||||||
| Total assets | $ | 237,774 | $ | 155,415 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,614 | $ | 1,874 | ||||
| Accrued expenses | 3,469 | 2,872 | ||||||
| Income taxes payable | 2,229 | |||||||
| Total current liabilities | 7,312 | 4,746 | ||||||
| Warrant liability | 1,457 | 1,584 | ||||||
| Series 1 nonconvertible preferred stock | 185 | 202 | ||||||
| Other long-term liabilities | 538 | 229 | ||||||
| Total liabilities | 9,492 | 6,761 | ||||||
| Total stockholders equity | 228,282 | 148,654 | ||||||
| Total liabilities and stockholders equity | $ | 237,774 | $ | 155,415 |
Enanta Pharmaceuticals, Inc.
MacDougall Biomedical Communications