Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2014

  Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second   Quarter Ended March 31, 2014  Business Wire  WATERTOWN, Mass. -- May 12, 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 second quarter ended March 31, 2014.  Fiscal Second Quarter Ended March 31, 2014 Financial Results  Revenue for the three months ended March 31, 2014 was $2.2 million, compared to $1.2 million for the three months ended March 31, 2013. For the six months ended March 31, 2014, revenue was $3.1 million, compared to revenue of $29.1 million for the same period in 2013. The changes in revenue for the three and six-month periods were 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 $4.7 million for the three months ended March 31, 2014, compared to $3.7 million for the three months ended March 31, 2013. For the six months ended March 31, 2014, research and development expenses were $9.0 million, compared to $8.5 million for the same period in 2013. The increase in the three and six month periods is primarily due to increased spending on Enanta’s proprietary research programs.  General and administrative expenses totaled $2.6 million for the three months ended March 31, 2014, compared to $1.5 million for the three months ended March 31, 2013. For the six months ended March 31, 2014, general and administrative expenses totaled $4.7 million, compared to $2.6 million for the same period in 2013. The increase in the three and six month periods is primarily due to an increase in stock-based compensation expense as well as additional expenses incurred as a result of operating as a public company.  Net loss for the three months ended March 31, 2014 was $5.2 million, compared to a net loss of $3.7 million for the same period in 2013. For the six months ended March 31 2014, net loss was $10.6 million, compared to net income of $18.2 million for the same period in 2013.  Cash, cash equivalents and marketable securities totaled $102.0 million at March 31, 2014. 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.  “There have been significant developments in Enanta’s partnered and proprietary programs for hepatitis C in recent months,” commented Jay R. Luly, Ph.D. President and Chief Executive Officer. “The recent U.S. NDA and MAA submissions by our partner AbbVie for its genotype 1 HCV regimen is an important step toward Enanta being part of the first wave of all-oral, interferon-free HCV treatments. In addition, our internal programs are advancing and we continue to explore new infectious disease areas for which we can apply our internal chemistry expertise.”  Program and Business Review    *AbbVie submitted a New Drug Application (NDA) to the U.S. Food and Drug     Administration in April and Marketing Authorization Applications (MAA) to     the European Medicines Agency in May, for its hepatitis C virus (HCV)     regimen containing the Enanta/AbbVie collaboration’s protease inhibitor     ABT-450. Enanta earned a $20 million milestone payment for each     submission.   *This quarter, Enanta’s NS5A inhibitor EDP-239, is expected to advance into     drug combination studies in healthy volunteers with alisporivir,     Novartis’s cyclophilin inhibitor. EDP-239 is being studied in     collaboration with Novartis on NS5A inhibitors for the treatment of HCV     infection.   *Detailed data from several phase 3 studies that include the Enanta/AbbVie     collaboration’s protease inhibitor ABT-450 were presented at the     International Liver Congress in London and at Digestive Disease Week in     Chicago.   *Pre-clinical data on ABT-493, a next-generation HCV NS3/4A protease     inhibitor identified within the Enanta/AbbVie collaboration, was presented     at the 21^st Conference on Retroviruses and Opportunistic Infections in     Boston. The data demonstrates that ABT-493 has a substantially improved in     vitro profile compared to earlier generation HCV NS3/4A protease     inhibitors and displays potent and broad genotypic activity in genotypes     1a, 1b, 2a, 3a, 4a and 6a.  Upcoming Events and Presentations  Enanta management will participate in the following upcoming investor conferences:    *Jefferies 2014 Global Healthcare Conference, June 2-5, 2014   *Wells Fargo 2014 Healthcare Conference, June 17-18, 2014   *JMP Securities Healthcare Conference, June 24-25, 2014  Conference Call and Webcast Information  Enanta will host a conference call and webcast today at 8:30 a.m. Eastern time to discuss these results and provide an update on its research and development pipeline. 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 11:30 a.m. Eastern time on May 12, 2014, through 11:59 p.m. Eastern time on May 16, 2014 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 31914722. A live audio webcast of the call and replay will be accessible on our website at www.enanta.com. Please visit the Investor home page of our website and search for calendar of events. A replay of the webcast will be available on www.enanta.com approximately two hours following the live webcast.  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 approval of AbbVie’s HCV treatment regimen containing ABT-450 for use in the U.S., the prospects for EDP-239 and Enanta’s internal programs, 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 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; 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; 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.  ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts)                                                                                                                                                              Three Months Ended        Six Months Ended                            March 31,                 March 31,                             2014       2013       2014        2013                                                                         Revenue                    $ 2,160      $ 1,196      $ 3,053       $ 29,055 Operating expenses        Research and          4,722        3,704        8,985         8,502        development        General and          2,565      1,493      4,652       2,645           administrative              Total              operating      7,287      5,197      13,637      11,147                expenses Income (loss) from           (5,127 )     (4,001 )     (10,584 )     17,908 operations Other income (expense),     (76    )    252        11          300      net Net income (loss)            (5,203 )     (3,749 )     (10,573 )     18,208                                                                     Accretion of redeemable convertible preferred stock to           -            (1,244 )     -             (2,526  ) redemption value Net income attributable to participating            -          -          -           (13,670 ) securities Net income (loss) attributable to common     $ (5,203 )   $ (4,993 )   $ (10,573 )   $ 2,012    stockholders                                                                                                                                         Net income (loss) per share attributable to common stockholders        Basic               $ (0.28  )   $ (2.28  )   $ (0.58   )   $ 1.21        Diluted             $ (0.28  )   $ (2.28  )   $ (0.58   )   $ 1.09 Weighted average common shares outstanding        Basic                 18,354       2,192        18,149        1,670        Diluted               18,354       2,192        18,149        3,084                                                                                ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)                                                                                                                    March 31,   September 30,                                                       2014         2013 Assets Current assets      Cash and cash equivalents                       $ 18,101    $   8,859      Short-term marketable securities                  76,669        92,621      Accounts receivable                               998           808      Unbilled receivables                              1,604         784      Prepaid expenses and other current assets        1,977        1,641         Total current assets                           99,349        104,713 Property and equipment, net                            1,377         1,121 Long-term marketable securities                        7,184         10,703 Restricted cash                                       436          436         Total assets                                 $ 108,346   $   116,973 Liabilities, Preferred Stock and Stockholders' Equity Current liabilities      Accounts payable                                $ 2,041     $   1,481      Accrued expenses                                  2,327         3,035      Deferred revenue                                 51           10         Total current liabilities                      4,419         4,526 Warrant liability                                      1,617         1,620 Series 1 nonconvertible preferred stock                206           - Other long-term liabilities                           389          359         Total liabilities                             6,631        6,505 Total stockholders' equity                            101,715      110,468         Total liabilities, preferred stock and       $ 108,346   $   116,973         stockholders' equity                                                                        Contact:  Investors Carol Miceli, 617-607-0710 Enanta Pharmaceuticals, Inc. cmiceli@enanta.com or Media Kari Watson, 781-235-3060 MacDougall Biomedical Communications kwatson@macbiocom.com  
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