Watch Live

Tweet TWEET

Egalet Reports Full Year 2013 Financial Results and Provides Business Update

 Egalet Reports Full Year 2013 Financial Results and Provides Business Update  -- Strengthened balance sheet with $73.0 million in aggregate gross proceeds from IPO and simultaneous private placement with Shionogi --  --Webcast and conference call today at 8:30 a.m. EDT--  PR Newswire  WAYNE, Pa., March 26, 2014  WAYNE, Pa., March 26, 2014 /PRNewswire/ --Egalet Corporation (Nasdaq: EGLT) ("Egalet") today reported business highlights and financial results for the year ended December 31, 2013. This marks the first time that Egalet is reporting its operating results as a public company.  Egalet Logo.  Recent corporate highlights include:    oInitiated pivotal bioequivalence studies of Egalet-001;   oReceived Fast Track designation from the FDA for Egalet-001, an     abuse-deterrent, extended-release, oral morphine formulation, and     Egalet-002, an abuse-deterrent, extended-release, oral oxycodone     formulation, both in development for the treatment of moderate to severe     chronic pain;   oAdded to the board of directors Timothy P. Walbert, chairman, president     and CEO of Horizon Pharma, and Greg Weaver, CFO, senior vice president,     treasurer and corporate secretary of Fibrocell Science, Inc.;   oEntered into a development, collaboration and license agreement with     Shionogi Limited ("Shionogi") related to abuse-deterrent oral hydrocodone     opioid product candidates under which Egalet received $10.0 million in an     upfront payment. Pursuant to this agreement, Egalet is entitled to receive     payments in excess of $300 million in aggregate upon the achievement of     development, regulatory and sales milestones and royalties on future net     product sales; and   oStrengthened the balance sheet with $73.0 million in aggregate gross     proceeds from initial public offering (IPO), subsequent exercise of the     underwriters' over-allotment option and concurrent private placement with     Shionogi resulting in $65.5 million in net proceeds after deducting     underwriting discounts and offering expenses.  "With the ongoing epidemic of opioid abuse and the successful completion of our IPO, we are well positioned to move forward with the development of our differentiated abuse-deterrent opioids," said Bob Radie, Egalet's president and chief executive officer. "Having just initiated the pivotal bioequivalence studies for Egalet-001, which has received Fast Track designation, we are one step closer to bringing patients a treatment option to manage their moderate to severe chronic pain while lowering the potential for abuse."  2013 Financial Results    oRevenue: There were no revenues for the year ended December 31, 2013     compared to net revenue of $1.2 million for the year ended December 31,     2012. The decrease was due to the completion of research and development     services under our collaborative agreements in 2012.   oR&D Expenses: Research and development expenses were $6.3 million for the     year ended December 31, 2013 compared to $4.3 million in 2012. The     increase of $2.0 million, or 47.6%, was driven primarily by a $2.3 million     increase in development costs for Egalet‑001 and a $609,000 increase in     other clinical and pre-clinical development costs, partially offset by an     $868,000 decrease in clinical trial expenses for Egalet‑002.   oG&A Expenses: General and administrative expenses increased to $4.9     million for 2013 compared to $2.2 million for 2012. The 117.4% increase     was primarily due to higher compensation, travel costs and     facility‑related expenses, which relate to the establishment of Egalet's     U.S. office and personnel hired in 2013, including Egalet's chief     financial officer. Egalet also incurred higher professional fees and     communication expenses in 2013 related to increased business development     efforts, the pursuit of licensing arrangements and preparations for the     IPO.   oNet (Loss) Income: Net loss was $20.2 million for the year ended December     31, 2013 compared to net loss of $5.4 million for the year ended December     31, 2012.    oCash Position: Cash as of December 31, 2013 was $15.7 million compared to     $3.4 million at December 31, 2012. The cash increase was primarily driven     by the $10.0 million upfront payment related to the development     collaboration and license agreement with Shionogi. Subsequent to year end,     Egalet further strengthened its balance sheet with $73.0 million in     aggregate gross proceeds or $65.5 million in net proceeds after     underwriters' discounts and offering expenses raised from its IPO, the     simultaneous private placement of 1.25 million shares of common stock with     Shionogi at the IPO price and the subsequent exercise of the underwriters'     over-allotment.  Upcoming Milestones    oQ1: Egalet plans to complete the first phase of category 1 abuse     deterrence studies for Egalet-001.   oQ2: Egalet plans to initiate category 2 and 3 abuse deterrence studies for     Egalet-001 and the second phase of category 1 abuse deterrence studies for     Egalet-002.   oQ3: Egalet plans to initiate category 2 and 3 abuse deterrence studies for     Egalet-002.   oQ4: Egalet plans to initiate its pivotal Phase 3 trial for Egalet-002. In     addition, Egalet plans to complete bioequivalence studies and submit a new     drug application (NDA) filing for Egalet-001.  Conference Call Information Egalet's management will host a conference call to discuss the 2013 financial results:  Date:                       Wednesday, March 26, 2014 Time:                       8:30 a.m. EDT Webcast (live and archive): http://egalet.investorroom.com/eventsandwebcasts                             1-877-870-4263 (domestic) Dial-in numbers:                             1-412-317-0790 (international)                             1-877-344-7529 (domestic)  Replay dial-in numbers:     1-412-317-0088 (international)                              Conference Number:10042524  About Egalet Egalet Corporation is a specialty pharmaceutical company developing and planning to commercialize proprietary, abuse-deterrent oral products for the treatment of pain and other indications. Egalet has created two distinct drug delivery systems, each with novel abuse-deterrent features and the ability to control the release profile of the active pharmaceutical ingredient (API). Using its proprietary platform, Egalet has developed a pipeline of clinical-stage, opioid-based product candidates in tablet form that are specifically designed to deter abuse by physical and chemical manipulation, while also providing tailored release of the active pharmaceutical ingredient. Its lead product candidate, Egalet-001, is an abuse-deterrent, extended-release, oral morphine formulation in development for the treatment of moderate to severe chronic pain. There are currently no commercially available abuse-deterrent formulations of morphine, and if approved, Egalet believes that Egalet-001 would fill a significant unmet need in the marketplace. Its second product candidate, Egalet-002, is an abuse-deterrent, extended-release, oral oxycodone formulation in development for the treatment of moderate to severe chronic pain. The Egalet technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple APIs with similar or different release profiles. Visit www.egalet.com for more information.  Safe Harbor Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations, and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: the success of our clinical trials; our ability to obtain regulatory approval of our product candidates; competitive factors; general market conditions; and other risks factors described in Egalet's filings with the United States Securities and Exchange Commission. Egalet assumes no obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.  Contacts: Investor Relations: Lisa M. Wilson In-Site Communications, Inc. Tel: 917-543-9932 Email: lwilson@insitecony.com  Media: E. Blair Clark-Schoeb Tel: 917-432-9275 Email: blair@biotechcomm.com  Tables Follow    Egalet Corporation and Subsidiaries Consolidated Balance Sheets                                                      December31,                                                      2012         2013 Assets Current assets: Cash                                                 $3,404,000   $15,700,000 Related party receivable                             34,000       — Prepaid expenses                                     680,000      1,812,000 Other receivables                                    319,000      231,000 Total current assets                                 4,437,000    17,734,000 Property and equipment, net                          931,000      2,378,000 Intangible asset                                     200,000      209,000 Deposits and other assets                            25,000       33,000 Total assets                                         $5,593,000   $20,363,000 Liabilities, convertible preferred stock, and stockholders' deficit Current liabilities: Related party senior convertible debt, net of        $—           $17,209,000 discount Accounts payable                                     1,334,000    1,046,000 Accrued expenses                                     581,000      1,755,000 Deferred revenue                                     —            10,149,000 Other current liabilities                            19,000       55,000 Total current liabilities                            1,934,000    30,214,000 Deferred income tax liabilities                      —            22,000 Total liabilities                                    1,934,000    30,236,000 Commitments and contingencies Convertible preferred stock: Convertible SeriesA‑1 preferred stock, $0.01 par value, 1,406,894 shares  issued and outstanding at December31, 2012 and 1,443,000    1,443,000 2013, liquidation  preference of $13,559,000 at December31, 2013 Convertible SeriesA‑2 preferred stock, $0.01 par value, 593,106 shares issued  and outstanding at December31, 2012 and 2013,  770,000      770,000 liquidation preference of  $4,083,000 at December31, 2013 Convertible SeriesB preferred stock, $0.01 par value, 2,327,301 shares issued  and outstanding at December31, 2012 and 2013,  12,628,000   12,628,000 liquidation preference of  $42,610,000 at December31, 2013 Convertible SeriesB‑1 preferred stock, $0.01 par value, 113,916 shares issued  and outstanding at December31, 2012 and 2013,  116,000      116,000 liquidation preference of  $695,000 at December31, 2013 Stockholders' deficit Common stock, $0.01 par value, 1,292,307 shares issued and outstanding at                            13,000       13,000  December31, 2012 and 2013 Additional paid in capital                           1,610,000    7,431,000 Accumulated other comprehensive income               271,000      1,125,000 Accumulated deficit                                  (13,192,000) (33,399,000) Total stockholders' deficit                          (11,298,000) (24,830,000) Total liabilities, convertible preferred stock and   $5,593,000   $20,363,000 stockholders' deficit  Egalet Corporation and Subsidiaries Consolidated Statements of Operations                                          Year Ended December31,                                          2012         2013 Revenues                                 $1,201,000   $          - Operating expenses: Research and development                 4,256,000    6,280,000 General and administrative               2,241,000    4,873,000 Total operating expenses                 6,497,000    11,153,000 Loss from operations                     (5,296,000)  (11,153,000) Interest expense                         75,000       8,842,000 Loss (gain) on foreign currency exchange 27,000       190,000                                          102,000      9,032,000 Loss from operations before income taxes (5,398,000)  (20,185,000) Provision for income taxes               -            22,000 Net loss                                 $(5,398,000) $(20,207,000)    Logo - http://photos.prnewswire.com/prnh/20140219/NY67493LOGO  SOURCE Egalet Corporation  Website: http://www.egalet.com  
Press spacebar to pause and continue. Press esc to stop.