WAYNE, Pa., Aug. 4, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced that the joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of ARYMO™ ER (morphine sulfate). ARYMO ER was developed using Egalet's proprietary Guardian™ Technology 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.
The committees also voted:
- 16 to 3 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the oral route of abuse;
- 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the nasal route of abuse; and
- 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.
"The Committees' support of ARYMO ER labeling as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse is an important step forward in the development of this product candidate," said Bob Radie, president and CEO of Egalet. "We believe ARYMO can offer patients, when appropriate, effective pain relief and can deter potential abuse. We will continue to work closely with the FDA over the next few months to bring this product to the market."
Based on the committees' votes, Egalet anticipates, if approved, the label for ARYMO ER will describe the product's abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the NDA for ARYMO ER. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.
Today the Company also reported financial results for the second quarter ended June 30, 2016.
Second Quarter 2016 Financial Results:
- Cash Position: As of June 30, 2016, Egalet had cash and marketable securities totaling $103.7 million.
- Revenue: Total net revenue was $3.5 million for the quarter ended June 30, 2016 compared to $959,000 for the quarter ended June 30, 2015. There were net product sales of $3.5 million for the quarter ended June 30, 2016 compared to $607,000 for the quarter ended June 30, 2015. Related party revenues decreased from $352,000 for the quarter ended June 30, 2015 to $0 for the quarter ended June 30, 2016 due to the termination of the collaboration agreement with Shionogi in the fourth quarter of 2015.
- Cost of Sales: Cost of sales was $784,000 for the quarter ended June 30, 2016 and $207,000 for the second 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 the average cost of inventory produced, which 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 second quarter of 2016 consisted of both SPRIX Nasal Spray and OXAYDO sales, while the second quarter in 2015 consisted only of SPRIX Nasal Spray sales.
- G&A Expenses: General and administrative expenses increased to $8.9 million for the quarter ended June 30, 2016 compared to $5.8 million for the same period in 2015. This was primarily attributable to increases in employee salary and benefits, due to the expansion of the U.S. organization, stock-based compensation expense, regulatory fees and professional fees associated with preparing for the August 4 FDA Advisory Committees meeting.
- S&M Expenses: Sales and marketing expenses increased to $6.3 million for the quarter ended June 30, 2016 from $3.3 million in the quarter ended June 30, 2015, primarily related to the growth in the U.S.-based commercial organization, including increases in salary and benefits, the contract sales force and sales and marketing for SPRIX Nasal Spray and OXAYDO.
- R&D Expenses: Research and development expenses increased to $8.7 million for the quarter ended June 30, 2016 from $4.9 million for the quarter ended June 30, 2015. The increase was driven primarily by an increase in development costs for Egalet-002 and OXAYDO, and offset by a decrease in development costs for ARYMO ER.
- Interest Expense: Interest expense was $2.3 million for the quarter ended June 30, 2016 and $2.3 million for the same period in 2015. Interest expense is due primarily to the loan agreement with Hercules and the 5.50% convertible notes.
- Net Loss: Net loss for the quarter ended June 30, 2016 was $23.8 million, or $0.97 per share, compared to a net loss of $17.1 million, or $1.03 per share, for the quarter ended June 30, 2015.
Conference Call Information
Results from the second quarter financial results and the FDA Advisory Committee meeting will be discussed on the conference call later today.
Time: 5:15 p.m. EDT
Webcast (live and archived): http://egalet.investorroom.com/eventsandwebcasts
Dial-in numbers:
- 1-888-346-2615 (domestic)
- 1-412-902-4253 (international)
Replay numbers:
- 1-877-344-7529 (domestic)
- 1-412-317-0088 (international)
Conference number: 10090245
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 anticipated labeling for ARYMO ER) 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 its product candidates; Egalet's ability to maintain the intellectual property position of its 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 raise additional funds related to execute its business plan and growth strategy in terms acceptable to Egalet, if at all; 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
Tables Attached
Egalet Corporation and Subsidiaries | |||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2015 | 2016 | 2015 | 2016 | ||||||||||
Revenues | |||||||||||||
Net product sales | $ | 607 | $ | 3,450 | $ | 769 | $ | 6,013 | |||||
Collaboration revenues | — | — | — | 100 | |||||||||
Related party revenues | 352 | — | 973 | — | |||||||||
Total revenue | 959 | 3,450 | 1,742 | 6,113 | |||||||||
Cost and Expenses | |||||||||||||
Cost of sales (excluding amortization of product rights) | 207 | 784 | 301 | 1,666 | |||||||||
Amortization of product rights | 585 | 503 | 963 | 1,004 | |||||||||
General and administrative | 5,804 | 8,854 | 10,499 | 14,852 | |||||||||
Sales and marketing | 3,284 | 6,280 | 4,859 | 12,482 | |||||||||
Research and development | 4,903 | 8,697 | 15,303 | 14,816 | |||||||||
Total costs and expenses | 14,783 | 25,118 | 31,925 | 44,820 | |||||||||
Loss from operations | (13,824) | (21,668) | (30,183) | (38,707) | |||||||||
Other (income) expense: | |||||||||||||
Change in fair value of derivative liability | 773 | (43) | 773 | (653) | |||||||||
Interest expense, net | 2,306 | 2,315 | 2,766 | 4,624 | |||||||||
Other (gain) loss | (2) | 69 | (2) | 66 | |||||||||
Loss on foreign currency exchange | 188 | 5 | 85 | 3 | |||||||||
3,265 | 2,346 | 3,622 | 4,040 | ||||||||||
Loss before provision (benefit) for income taxes | (17,089) | (24,014) | (33,805) | (42,747) | |||||||||
Provision (benefit) for income taxes | (23) | (237) | 3 | (422) | |||||||||
Net loss | $ | (17,066) | $ | (23,777) | $ | (33,808) | $ | (42,325) | |||||
Per share information: | |||||||||||||
Net loss per share of common stock, basic and diluted | $ | (1.03) | $ | (0.97) | $ | (2.05) | $ | (1.73) | |||||
Weighted-average shares outstanding, basic and diluted | 16,506,798 | 24,468,747 | 16,481,354 | 24,437,497 | |||||||||
Egalet Corporation and Subsidiaries | |||||||
December 31, 2015 | June 30, 2016 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 46,665 | $ | 35,021 | |||
Marketable securities, available for sale | 99,042 | 68,647 | |||||
Accounts receivable | 295 | 820 | |||||
Related party receivable | 57 | - | |||||
Inventory | 1,837 | 1,742 | |||||
Prepaid expenses and other current assets | 1,295 | 1,142 | |||||
Other receivables | 1,047 | 1,089 | |||||
Total current assets | 150,238 | 108,461 | |||||
Intangible assets, net | 10,380 | 9,405 | |||||
Property and equipment, net | 7,801 | 12,268 | |||||
Deposits and other assets | 3,997 | 3,440 | |||||
Total assets | $ | 172,416 | $ | 133,574 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | 7,417 | 6,112 | |||||
Accrued expenses | 7,616 | 9,026 | |||||
Deferred revenue | 10,128 | 7,182 | |||||
Debt - current | 3,320 | 6,809 | |||||
Other current liabilities | 183 | 383 | |||||
Total current liabilities | 28,664 | 29,512 | |||||
Debt - non-current portion, net | 52,442 | 51,439 | |||||
Deferred income tax liability | 1,084 | 662 | |||||
Derivative liability | 656 | 3 | |||||
Other liabilities | 348 | 1,504 | |||||
Total liabilities | 83,194 | 83,120 | |||||
Commitments and contingencies (Note 10) | |||||||
Stockholders' equity | |||||||
Common stock--$0.001 par value; 75,000,000 shares authorized at December 31, 2015 and June 30, 2016; 25,085,554 and 25,094,122 shares issued and outstanding at December 31, 2015 and June 30, 2016, respectively | 25 | 25 | |||||
Additional paid-in capital | 223,784 | 226,808 | |||||
Accumulated other comprehensive (loss) income | (41) | 495 | |||||
Accumulated deficit | (134,546) | (176,874) | |||||
Total stockholders' equity | 89,222 | 50,454 | |||||
Total liabilities and stockholders' equity | $ | 172,416 | $ | 133,574 | |||
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SOURCE Egalet Corporation
