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): February 13, 2014
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 and zip code)
(617) 607-0800
(Registrant’s telephone number, including area code)
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 (see General Instruction A.2. below):
| ¨ | 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)) |
Item 2.02 Results of Operations and Financial Condition.
On February 13, 2014, Enanta Pharmaceuticals, Inc. announced via press release its results for the quarter ended December 31, 2013. 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 No. |
Description | |
| 99.1 | Press Release of Enanta Pharmaceuticals, Inc., dated February 13, 2014, reporting Enanta’s financial results for the quarter ended December 31, 2013. | |
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 hereunto duly authorized.
| Date: February 13, 2014 | ENANTA PHARMACEUTICALS, INC. | |||||
| By: | /s/ Paul J. Mellett | |||||
| Paul J. Mellett | ||||||
| Senior Vice President, Finance and Administration and Chief Financial Officer | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release of Enanta Pharmaceuticals, Inc., dated February 13, 2014, reporting Enanta’s financial results for the quarter ended December 31, 2013. | |
Exhibit 99.1
For Immediate Release
Enanta Pharmaceuticals Reports Financial Results for its
Fiscal First Quarter Ended December 31, 2013
WATERTOWN, Mass., February 13, 2014 — Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today reported financial results for its fiscal first quarter ended December 31, 2013.
Fiscal First Quarter Ended December 31, 2013 Financial Results
Revenue for the three months ended December 31, 2013 was $0.9 million compared to $27.9 million for the three months ended December 31, 2012. The changes in revenue for the three-month periods are primarily related to the timing and amount of milestone and other payments from collaborations, which have varied significantly from period to period and are expected to continue to do so.
Research and development expenses totaled $4.3 million for the three months ended December 31, 2013 compared to $4.8 million for the three months ended December 31, 2012. The decrease is primarily due to a decrease in preclinical spending.
General and administrative expenses totaled $2.1 million for the three months ended December 31, 2013 compared to $1.2 million for the three months ended December 31, 2012. The increase is primarily due to additional expenses incurred as a result of operating as a public company.
Net loss for the three months ended December 31, 2013 was $5.4 million compared to a net income of $22.0 million for the same period in 2012.
Cash, cash equivalents and marketable securities totaled $106.2 million at December 31, 2013. This compares to $112.2 million at September 30, 2013. Enanta expects that its current cash, cash equivalents and marketable securities will be sufficient to meet its anticipated cash requirements for at least the next 24 months.
“Enanta is beginning 2014 with a strong cash position and four compounds in the clinic,” stated Jay R. Luly, Ph.D., President and Chief Executive Officer. “Our partner AbbVie recently completed the largest phase 3 program to date for an all-oral, genotype 1 hepatitis C virus treatment regimen, and it expects to launch the regimen in 2014. AbbVie’s tested regimen includes our collaboration’s lead protease compound ABT-450. In addition, we continue to explore new infectious disease areas and have recently initiated a phase 1 study of our proprietary bicyclolide candidate EDP-788 which we are developing for MRSA.”
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Pipeline and Business Review
| • | Topline data from all six of the phase 3 hepatitis C virus registration studies for the ABT-450 containing regimen have now been released demonstrating sustained virologic response rates 12 weeks post treatment (SVR12) in genotype 1 (GT1) subtypes, including 92 to 96 percent in cirrhotic patients |
| • | Timothy D. Ocain, Ph.D. was appointed Senior Vice President, New Product Strategy and Development |
| • | Enrollment has begun in two phase 3 studies in Japan, GIFT-I and GIFT II, for GT1 and GT2 HCV patients respectively |
| • | A phase 1 study of methicillin-resistant Staphylococcus aureus (MRSA) infection candidate Bicyclolide EDP-788 was initiated |
| • | Bruce L.A. Carter, Ph.D. and George S. Golumbeski, Ph.D. were appointed to Enanta’s Board of Directors |
Upcoming Events and Presentations
| • | Enanta management will participate in the Leerink Global Healthcare Conference in New York City at 2:15 p.m. ET today. |
About Enanta
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 in the infectious disease field. Enanta is discovering, and in some cases, developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of three direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for commercial launch of AbbVie’s HCV treatment regimen containing ABT-450, further clinical development of EDP-788, and the projected sufficiency of Enanta’s cash equivalent resources. 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
| Enanta Pharmaceuticals, Inc. | Page | 2 of 5 |
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 reliance on AbbVie’s planned regulatory submissions and commercialization efforts for its treatment regimens containing ABT-450 or any additional collaboration protease inhibitor and on the efforts of NIAID for the early clinical development of EDP-788; regulatory actions affecting approval of treatment regimens containing ABT-450 or any additional protease inhibitors; clinical and commercial development of competitive product candidates of others for HCV and other viruses or for MRSA and other bacteria; 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, 2013 and other periodic reports filed 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.
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ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
| Three Months Ended December 31, |
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| 2013 | 2012 | |||||||
| Revenue |
$ | 893 | $ | 27,859 | ||||
| Operating expenses |
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| Research and development |
4,263 | 4,798 | ||||||
| General and administrative |
2,087 | 1,152 | ||||||
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| Total operating expenses |
6,350 | 5,950 | ||||||
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| Income (loss) from operations |
(5,457 | ) | 21,909 | |||||
| Other income, net |
87 | 48 | ||||||
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| Net income (loss) |
(5,370 | ) | 21,957 | |||||
| Accretion of redeemable convertible preferred stock to redemption value |
— | (1,282 | ) | |||||
| Net income attributable to participating securities |
— | (18,807 | ) | |||||
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| Net income (loss) attributable to common stockholders |
$ | (5,370 | ) | $ | 1,868 | |||
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| Net income (loss) per share attributable to common stockholders |
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| Basic |
$ | (0.30 | ) | $ | 1.61 | |||
| Diluted |
$ | (0.30 | ) | $ | 1.45 | |||
| Weighted average common shares outstanding |
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| Basic |
17,949 | 1,158 | ||||||
| Diluted |
17,949 | 2,637 | ||||||
| Enanta Pharmaceuticals, Inc. | Page | 4 of 5 |
ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| December 31, 2013 |
September 30, 2013 |
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| Assets |
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| Current assets |
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| Cash and cash equivalents |
$ | 4,426 | $ | 8,859 | ||||
| Short-term marketable securities |
87,469 | 92,621 | ||||||
| Accounts receivable |
279 | 808 | ||||||
| Unbilled receivables |
929 | 784 | ||||||
| Prepaid expenses and other current assets |
1,275 | 1,641 | ||||||
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| Total current assets |
94,378 | 104,713 | ||||||
| Property and equipment, net |
1,077 | 1,121 | ||||||
| Long-term marketable securities |
14,267 | 10,703 | ||||||
| Restricted cash |
436 | 436 | ||||||
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| Total assets |
$ | 110,158 | $ | 116,973 | ||||
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| Liabilities and Stockholders’ Equity |
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| Current liabilities |
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| Accounts payable |
$ | 840 | $ | 1,481 | ||||
| Accrued expenses |
1,723 | 3,035 | ||||||
| Deferred revenue |
5 | 10 | ||||||
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| Total current liabilities |
2,568 | 4,526 | ||||||
| Warrant liability |
1,637 | 1,620 | ||||||
| Other long-term liabilities |
373 | 359 | ||||||
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| Total liabilities |
4,578 | 6,505 | ||||||
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| Total stockholders’ equity |
105,580 | 110,468 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 110,158 | $ | 116,973 | ||||
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Investor Contact
Carol Miceli
Enanta Pharmaceuticals, Inc.
617-607-0710
cmiceli@enanta.com
Media Contact
Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com
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