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): May 8, 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 May 8, 2013, Enanta Pharmaceuticals, Inc. announced via press release its results for the quarter ended March 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 May 8, 2013, reporting Enanta’s financial results for the quarter ended March 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: May 8, 2013 | ENANTA PHARMACEUTICALS, INC. | |||||
| By: | /s/ Paul J. Mellett | |||||
| Paul J. Mellett | ||||||
| Chief Financial Officer | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release of Enanta Pharmaceuticals, Inc., dated May 8, 2013, reporting Enanta’s financial results for the quarter ended March 31, 2013. | |
Exhibit 99.1
For Immediate Release
Enanta Pharmaceuticals Announces Financial Results for the
Second Fiscal Quarter and Six Months Ended March 31, 2013
WATERTOWN, Mass., May 8, 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 second fiscal quarter and six months ended March 31, 2013.
Second Fiscal Quarter and Six Months Ended March 31, 2013 Financial Results (unaudited)
Revenue for the three months ended March 31, 2013 was $1.2 million and $29.1 million for the six months ended March 31, 2013. This compares to $36.6 million for the three months ended March 31, 2012 and $37.3 million for the six months ended March 31, 2012. The $1.2 million in revenue for the three months ended March 31, 2013 was primarily due to Enanta’s NIAID contract. The $29.1 million in revenue for the six months ended March 31, 2013 primarily reflects the $15 million milestone payment from AbbVie, as well the $11 million milestone payment from Novartis. Revenue for the three and six month periods in 2012 are primarily due to an upfront payment of $34 million received from Novartis when Enanta entered into a collaboration and license agreement for its NS5A inhibitor, EDP-239, in February 2012.
Research and development expenses totaled $3.9 million for the three months ended March 31, 2013 and $8.7 million for the six months ended March 31, 2013. This compares to $3.3 million for the three months ended March 31, 2012 and $5.9 million for the six months ended March 31, 2012. The increase in research and development expenses for the three and six month periods of 2013 compared to the comparable periods in 2012 is primarily due to increased preclinical study activity for both Enanta’s cyclophilin inhibitor program and its antibiotic contract with NIAID.
General and administrative expenses totaled $1.3 million for the three months ended March 31, 2013 and $2.5 million for the six months ended March 31, 2013. This compares to $1.2 million for the three months ended March 31, 2012 and $2.5 million for the six months ended March 31, 2012.
Net loss for the three months ended March 31, 2013 was $3.7 million compared to a net income of $32.1 million for the same period in 2012. Net income for the six months ended March 31, 2013 was $18.2 million compared to $29.0 million for the same period ended 2012.
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Cash, cash equivalents and marketable securities totaled $121.7 million at March 31, 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.
“With our successful initial public offering in March, Enanta remains well-funded and positioned to advance our proprietary HCV assets through early clinical development and to fund new research and development activities,” stated Jay R. Luly, Ph.D., president and chief executive officer. “In addition, our three partnered, clinical-stage HCV candidates continue to progress in trials and have the potential to be part of multiple HCV combination regimens.”
Recent Developments
| • | A milestone payment of $11 million was received from Novartis in January for the initiation of a Phase 1 clinical trial that includes EDP-239. EDP-239 is Enanta’s NS5A inhibitor for Hepatitis C Virus (HCV) which is being developed by Novartis. |
| • | The Company closed its IPO on March 26, 2013 resulting in net proceeds of $59.9 million. |
| • | New data on HCV protease inhibitor ABT-450 from the “Aviator” study, a Phase 2b interferon-free combination study being performed by AbbVie, was presented in April 2013 at the Annual Meeting of the European Association for the Study of the Liver (EASL). 12 weeks of treatment demonstrated high SVR12 and SVR24 rates of 99% and 96%, respectively, in patients new to treatment (naïve) and SVR12 and SVR24 rates of 93% in patients who had previously failed treatment with pegylated interferon and ribavirin (null responders). |
| • | Breakthrough Therapy designation was granted by the U.S. Food and Drug Administration to AbbVie’s investigational HCV combination treatment regimen containing ABT-450, Enanta’s lead protease inhibitor. |
Upcoming Events and Presentations
Enanta management will present a corporate overview at the following investor conferences:
| • | Jefferies 2013 Healthcare Conference, June 3-6, 2013, New York |
| • | Wells Fargo Securities 2013 Healthcare Conference, Boston, June 18-19, 2013 |
| • | JMP Securities Healthcare Conference, July 9-10, 2013, New York |
Presentations related to ABT-450
| • | Digestive Disease Week, Orlando, FL, May 20, 2013 |
Maribel Rodriguez-Torres, et al.
“Interferon-Free Regimens of ABT-450/r, ABT-267, ABT-333 and Ribavirin Achieve High Sustained Virologic Response 4 Weeks Post-Treatment (SVR4) Rates in Patients with Chronic HCV Genotype 1 Regardless of Race, Ethnicity, or other Baseline Characteristic”
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
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infectious disease field. Enanta is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the 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 current 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 clinical development of ABT-450 and EDP-239, funding and prospects for Enanta’s other proprietary programs, and the Breakthrough Therapy designation that the FDA has given to AbbVie’s investigational HCV combination treatment regimen containing 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 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 treatment regimens containing ABT-450 or any additional collaboration protease inhibitor and of Novartis for any regimen containing EDP-239 or any additional NS5A inhibitor; regulatory actions affecting clinical development or treatment regimens containing ABT-450, EDP-239 or any additional protease or NS5A inhibitors or any other inhibitors in Enanta’s proprietary programs; 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; difficulties in Enanta commercializing any future proprietary drug candidates; 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 Registration Statement on Form S-1 (Registration No. 333-184779) and periodic reports filed subsequently 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 March 31, |
Six Months Ended March 31, |
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| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Revenue |
$ | 1,196 | $ | 36,565 | $ | 29,055 | $ | 37,306 | ||||||||
| Operating expenses |
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| Research and development |
3,855 | 3,263 | 8,653 | 5,935 | ||||||||||||
| General and administrative |
1,342 | 1,207 | 2,494 | 2,458 | ||||||||||||
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| Total operating expenses |
5,197 | 4,470 | 11,147 | 8,393 | ||||||||||||
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| Income from operations |
(4,001 | ) | 32,095 | 17,908 | 28,913 | |||||||||||
| Other income (expense) |
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| Interest income |
47 | 15 | 82 | 29 | ||||||||||||
| Interest expense |
(9 | ) | — | (16 | ) | — | ||||||||||
| Change in fair value of warrant liability |
214 | 1 | 234 | 10 | ||||||||||||
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| Total other income (expense), net |
252 | 16 | 300 | 39 | ||||||||||||
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| Net income (loss) |
(3,749 | ) | 32,111 | 18,208 | 28,952 | |||||||||||
| Accretion of redeemable convertible preferred stock to redemption value |
(1,244 | ) | (1,331 | ) | (2,526 | ) | (2,705 | ) | ||||||||
| Net income (loss) allocable to participating securities |
— | (25,279 | ) | (12,329 | ) | (21,802 | ) | |||||||||
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| Net income (loss) allocable to common stockholders |
(4,993 | ) | 5,501 | 3,353 | 4,445 | |||||||||||
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| Net income (loss) per share allocable to common stockholders: |
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| Basic |
(2.28 | ) | 2.41 | 1.21 | 2.06 | |||||||||||
| Diluted |
(2.28 | ) | 2.17 | 1.09 | 1.87 | |||||||||||
| Weighted average common shares outstanding: |
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| Basic |
2,192,470 | 1,088,251 | 1,669,578 | 1,053,912 | ||||||||||||
| Diluted |
2,192,470 | 2,536,900 | 3,084,084 | 2,377,211 | ||||||||||||
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ENANTA PHARMACEUTICALS, INC
CONDENSED BALANCED SHEET DATA
(In thousands)
| March 31, 2013 |
September 30, 2012 |
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| Assets |
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| Current assets |
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| Cash and cash equivalents |
$ | 74,464 | $ | 10,511 | ||||
| Short-term marketable securities |
34,647 | 33,251 | ||||||
| Accounts receivable |
669 | 1,049 | ||||||
| Unbilled receivable |
768 | 1,893 | ||||||
| Prepaid expenses and other current assets |
1,116 | 604 | ||||||
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| Total current assets |
111,664 | 47,308 | ||||||
| Property and equipment, net |
876 | 611 | ||||||
| Long-term marketable securities |
12,629 | 1,656 | ||||||
| Restricted cash |
436 | 436 | ||||||
| Other assets |
22 | 2,151 | ||||||
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| Total assets |
$ | 125,627 | $ | 52,162 | ||||
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| Liabilities and Stockholders’ Equity (Deficit) |
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| Current liabilities |
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| Accounts payable |
$ | 2,371 | $ | 1,851 | ||||
| Accrued expenses |
2,465 | 3,866 | ||||||
| Deferred Revenue |
115 | 17 | ||||||
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| Total current liabilities |
4,951 | 5,734 | ||||||
| Warrant liability |
1,767 | 2,001 | ||||||
| Other long-term liabilities |
534 | 498 | ||||||
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| Total liabilities |
7,252 | 8,233 | ||||||
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| Total stockholders’ equity (deficit) |
118,375 | (115,353 | ) | |||||
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| Total liabilities and stockholders’ equity (deficit) |
$ | 125,627 | $ | 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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