Egalet Reports First Quarter 2016 Financial Results

WAYNE, Pa., May 10, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today reported financial results for the first quarter ended March 31, 2016.  

"Highlights from the first quarter include the FDA's acceptance of our NDA for ARYMO ER, an abuse-deterrent, extended-release morphine product candidate, and momentum building with the commercialization of our two approved products, SPRIX Nasal Spray and OXAYDO," said Bob Radie, Egalet's president and chief executive officer. "If approved later this year, we will be able to begin promoting ARYMO ER leveraging our commercial experience over the past 12 months having built relationships with key pain health care professional, pharmacists and payers."

First Quarter 2016 Financial Results:

• Cash Position: As of March 31, 2016, Egalet had cash and marketable securities totaling $123.6 million.
• Revenue: Total net revenue was $2.7 million for the quarter ended March 31, 2016 compared to $805,000 for the quarter ended March 31, 2015. There were net product sales of $2.6 million for the quarter ended March 31, 2016 compared to $162,000 for the quarter ended March 31, 2015. Related party revenues decreased from $643,000 for the quarter ended March 31, 2015 to $0 for the quarter ended March 31, 2016 due to the termination of the collaboration agreement with Shionogi in the fourth quarter of 2015. Collaboration revenue of $100,000 for the quarter ended March 31, 2016 consisted entirely of revenue recognized under the SPRIX Nasal Spray marketing agreement with Septodont, Inc.
• Cost of Sales: Cost of sales was $882,000 for the quarter ended March 31, 2016 and $94,000 for the first quarter of 2015 related to the sales of SPRIX Nasal Spray and OXAYDO. The cost of sales for SPRIX Nasal Spray (excluding product amortization rights) reflects the fair value of finished goods inventory that was acquired as part of the acquisition and was dispensed to patients during the period. The cost of sales for OXAYDO (excluding product amortization rights) reflects the average costs of inventory dispensed to patients during the period. Cost of sales for the first quarter of 2016 consisted of both SPRIX Nasal Spray and OXAYDO sales, while the first quarter in 2015 consisted only of SPRIX Nasal Spray sales. 
• G&A Expenses: General and administrative expenses increased to $6.0 million for the quarter ended March 31, 2016 compared to $4.9 million for the same period in 2015. This was primarily attributable to increases in employee salary and benefits and professional and administrative fees due to the growth of our U.S. operations. These increases were offset by a decrease in regulatory fees.
• S&M Expenses: Sales and marketing expenses increased to $6.2 million for the quarter ended March 31, 2016 from $1.6 million in the quarter ended March 31, 2015. Expenses for the quarter ended March 31, 2016 consisted primarily of costs related to the contract sales force, sales and marketing operations for SPRIX Nasal Spray and OXAYDO, as well as salary and benefit expenses of new sales and marketing personnel.
• R&D Expenses: Research and development expenses decreased to $6.1 million for the quarter ended March 31, 2016 from $10.3 million for the quarter ended March 31, 2015. The decrease was driven primarily by a decrease in ARYMO ER clinical expenses and Egalet-002 manufacturing development expenses and a decrease in stock compensation expense, partially offset by increases in salary, benefits and administrative expenses.
• Interest Expense: Interest expense increased to $2.3 million for the quarter ended March 31, 2016 from $451,000 for the same period in 2015. Interest expense for the quarter ended March 31, 2016 was primarily attributable to the interest expense on the 5.50% convertible notes and the Hercules loan.
• Net Loss: Net loss for the quarter ended March 31, 2016 was $18.5 million, or $0.76 per share, compared to a net loss of $16.7 million, or $1.02 per share, for the quarter ended March 31, 2015.

Conference Call Information

Egalet's management will host a conference call to discuss the first quarter 2016 financial results:

About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has two approved products: OXAYDO^® (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX^® (ketorolac tromethamine) Nasal Spray. In addition, using its proprietary Guardian™ Technology, Egalet is developing a pipeline of clinical-stage, product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO™ ER, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Egalet's Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles. For additional information on Egalet, please visit egalet.com. For full prescribing information on SPRIX, including the boxed warning, please visit sprix.com. For full prescribing information on OXAYDO, please visit oxaydo.com.

Safe Harbor
Statements included in this press release (including but not limited to upcoming milestones) 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 Egalet's clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; Egalet's ability to obtain regulatory approval of Egalet's product candidates; Egalet's ability to maintain the intellectual property position of Egalet's products and product candidates; Egalet's ability to identify and reliance upon qualified third parties to manufacture its products; Egalet's ability to service its debt obligations; Egalet's ability to find and hire qualified sales professionals; the receptivity in the marketplace and among physicians to Egalet's products; the success of products which compete with Egalet's that are or become available; general market conditions; and other risk 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.

Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275

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SOURCE Egalet Corporation