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 12, 2013
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 August 12, 2013, Enanta Pharmaceuticals, Inc. announced via press release its results for the quarter ended June 30, 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 |
Description | |
| 99.1 | Press Release of Enanta Pharmaceuticals, Inc., dated August 12, 2013, reporting Enanta’s financial results for the quarter ended June 30, 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: August 12, 2013 | ENANTA PHARMACEUTICALS, INC. | |||||
| By: | /s/ Paul J. Mellett | |||||
| Paul J. Mellett | ||||||
| Chief Financial Officer | ||||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press Release of Enanta Pharmaceuticals, Inc., dated August 12, 2013, reporting Enanta’s financial results for the quarter ended June 30, 2013. | |
Exhibit 99.1
For Immediate Release
Enanta Pharmaceuticals Reports Financial Results for the
Third Fiscal Quarter and Nine Months Ended June 30, 2013
WATERTOWN, Mass., August 12, 2013 – 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 third fiscal quarter and nine months ended June 30, 2013.
Third Fiscal Quarter and Nine Months Ended June 30, 2013 Financial Results (unaudited)
Revenue for the three months ended June 30, 2013 was $1.6 million compared to $2.5 million for the three months ended June 30, 2012, and $30.7 million for the nine months ended June 30, 2013 compared to $39.8 million for the nine months ended June 30, 2012. The change in revenue for the nine-month periods is primarily related to the timing and amount of milestone payments from collaborations, which are expected to vary significantly from period to period.
Research and development expenses totaled $4.0 million for the three months ended June 30, 2013 compared to $4.9 million for the three months ended June 30, 2012, and $12.5 million for the nine months ended June 30, 2013 compared to $10.9 million for the nine months ended June 30, 2012. The increase in research and development expenses for the nine-month period is primarily due to increases in external preclinical expenses for our early stage drug discovery programs.
General and administrative expenses totaled $1.8 million for the three months ended June 30, 2013 compared to $1.1 million for the three months ended June 30, 2012, and $4.4 million for the nine months ended June 30, 2013 compared to $3.6 million for the nine months ended June 30, 2012. The increase in these expenses is primarily due to higher stock-based compensation expense related to additional employee stock options and to additional professional fees incurred as a result of operating as a public company.
Net loss for the three months ended June 30, 2013 was $4.1 million compared to a net loss of $3.5 million for the same period in 2012. Net income for the nine months ended June 30, 2013 was $14.1 million compared to $25.5 million for the same period ended 2012.
Cash, cash equivalents and marketable securities totaled $114.8 million at June 30, 2013. This compares to $45.4 million at September 30, 2012. The Company 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.
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“Our all oral, antiviral hepatitis C pipeline continues to progress with three compounds advancing in clinical development,” stated Jay R. Luly, Ph.D., President and Chief Executive Officer. “For our most advanced compound, ABT-450, our partner has completed enrollment in all six Phase 3 registration studies, and data are expected to read out later this year and into early 2014.”
Recent Developments
| • | Six Phase 3 registration studies that include ABT-450, Enanta and AbbVie’s collaborative protease inhibitor for hepatitis C (HCV), are fully enrolled, and a New Drug Application is expected to be filed in calendar 2Q 2014 |
| • | Combination studies of ABT-493 (Enanta and AbbVie’s next-generation collaborative protease inhibitor for HCV) with ABT-530 (AbbVie’s next-generation NS5A inhibitor) were recently initiated, and Phase 2 studies are expected to begin in 2013 |
| • | Enanta was added to the Russell 3000 and Russell 2000 Indexes on June 28, 2013 |
| • | A proof-of-concept study of EDP-239 (Enanta’s NS5A inhibitor) was recently initiated by Novartis, Enanta’s development partner for NS5A compounds for HCV |
Upcoming Events and Presentations
Enanta management will participate at the following events:
| • | August 12, 2013: Jefferies 2013 Boston Healthcare Summit, Boston, MA |
| • | September 3, 2013: Citi’s 8th Annual Biotech Conference, Boston, MA |
| • | September 11-12, 2013: Stifel 2013 Healthcare Conference, Boston, MA |
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 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 further clinical development of ABT-450, ABT-493 and EDP-239 and the expected timeline for results of Phase 3 studies of regimens that include ABT-450. 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
| Enanta Pharmaceuticals, Inc. | Page | 2 of 5 |
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 reliance on the development and commercialization efforts of AbbVie for treatment regimens containing ABT-450, ABT-493 or any additional collaboration protease inhibitor and of Novartis for any treatment regimen containing EDP-239 or any additional NS5A inhibitor; regulatory actions affecting clinical development or treatment regimens containing ABT-450, ABT-493, EDP-239 or any additional protease or NS5A inhibitors; clinical development of competitive product candidates of others for HCV and other viruses; Enanta’s lack of clinical development experience; Enanta’s need to attract and retain senior management and key scientific personnel; Enanta’s lack of resources and experience commercializing drugs, including any future proprietary drug candidates it may develop; 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 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 STATEMENT OF OPERATIONS
(In thousands, except per share amounts)
| Three Months
Ended June 30, |
Nine Months
Ended June 30, |
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| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Revenue |
$ | 1,649 | $ | 2,542 | $ | 30,704 | $ | 39,848 | ||||||||
| Operating expenses |
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| Research and development |
4,039 | 4,925 | 12,541 | 10,860 | ||||||||||||
| General and administrative |
1,788 | 1,145 | 4,433 | 3,603 | ||||||||||||
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| Total operating expenses |
5,827 | 6,070 | 16,974 | 14,463 | ||||||||||||
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| Income from operations |
(4,178 | ) | (3,528 | ) | 13,730 | 25,385 | ||||||||||
| Other income (expense) |
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| Interest income |
64 | 48 | 146 | 77 | ||||||||||||
| Interest expense |
(7 | ) | — | (23 | ) | — | ||||||||||
| Change in fair value of warrant liability |
(17 | ) | (21 | ) | 217 | (11 | ) | |||||||||
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| Total other income (expense), net |
40 | 27 | 340 | 66 | ||||||||||||
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| Net income (loss) |
(4,138 | ) | (3,501 | ) | 14,070 | 25,451 | ||||||||||
| Accretion of redeemable convertible preferred stock to redemption value |
— | (1,330 | ) | (2,526 | ) | (4,035 | ) | |||||||||
| Net income (loss) allocable to participating securities |
— | — | (13,670 | ) | (19,606 | ) | ||||||||||
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| Net income (loss) allocable to common stockholders |
$ | (4,138 | ) | $ | (4,831 | ) | $ | (2,126 | ) | $ | 1,810 | |||||
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| Net income (loss) per share allocable to common stockholders: |
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| Basic |
$ | (0.23 | ) | $ | (4.31 | ) | $ | (0.30 | ) | $ | 1.68 | |||||
| Diluted |
$ | (0.23 | ) | $ | (4.31 | ) | $ | (0.30 | ) | $ | 1.52 | |||||
| Weighted average common shares outstanding: |
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| Basic |
17,819,813 | 1,120,400 | 7,052,989 | 1,075,993 | ||||||||||||
| Diluted |
17,819,813 | 1,120,400 | 7,052,989 | 2,436,637 | ||||||||||||
| Enanta Pharmaceuticals, Inc. | Page | 4 of 5 |
ENANTA PHARMACEUTICALS, INC
CONDENSED BALANCE SHEET DATA
(In thousands)
| June 30, 2013 |
September 30, 2012 |
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| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ | 18,878 | $ | 10,511 | ||||
| Short-term marketable securities |
75,668 | 33,251 | ||||||
| Accounts receivable |
876 | 1,049 | ||||||
| Unbilled receivables |
981 | 1,893 | ||||||
| Prepaid expenses and other current assets |
1,463 | 604 | ||||||
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| Total current assets |
97,866 | 47,308 | ||||||
| Property and equipment, net |
1,152 | 611 | ||||||
| Long-term marketable securities |
20,217 | 1,656 | ||||||
| Restricted cash |
436 | 436 | ||||||
| Other assets |
— | 2,151 | ||||||
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| Total assets |
$ | 119,671 | $ | 52,162 | ||||
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| Liabilities and Stockholders’ Equity (Deficit) |
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| Current liabilities: |
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| Accounts payable |
$ | 918 | $ | 1,851 | ||||
| Accrued expenses |
2,023 | 3,866 | ||||||
| Deferred Revenue |
— | 17 | ||||||
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| Total current liabilities |
2,941 | 5,734 | ||||||
| Warrant liability |
1,784 | 2,001 | ||||||
| Other long-term liabilities |
535 | 498 | ||||||
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| Total liabilities |
5,260 | 8,233 | ||||||
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| Redeemable convertible preferred stock |
158,955 | |||||||
| Convertible preferred stock |
327 | |||||||
| Total stockholders’ equity (deficit) |
114,411 | (115,353 | ) | |||||
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| Total liabilities and stockholders’ equity (deficit) |
$ | 119,671 | $ | 52,162 | ||||
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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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