Egalet Reports Third Quarter 2014 Financial Results And Provides Business Update

WAYNE, Penn., Nov. 12, 2014 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet") today reported business highlights and financial results for the three months ended September 30, 2014. 

Third quarter highlights include:

• Presented two posters from Category 1 abuse-deterrence studies at PainWeek that support Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and highlight its abuse-deterrent characteristics;
• Completed three bioequivalence studies of Egalet-001;
• Began planning for Phase 3 trial of Egalet-001;
• Had a successful end-of-phase 2 meeting with the U.S. Food and Drug Administration regarding Egalet-002, an extended-release, abuse-deterrent oxycodone;
• Hired Jeffrey M. Dayno, M.D. as chief medical officer; and
• Added to patent portfolio providing protection with dates extending between 2022 and 2032.

"To deliver on our mission of bringing medications to those living with significant pain while offering patients and physicians peace of mind, we are focused on moving our differentiated abuse-deterrent formulations through development," said Bob Radie, Egalet's president and chief executive officer. "We are completing the final stages of planning for our three Phase 3 studies for Egalet-001 and Egalet-002 that will begin in the first quarter of 2015."

Q3 Financial Results

• Cash Position: Cash as of September 30, 2014 was $59.7 million compared to $69.3 million at June 30, 2014. Our primary use of cash was, and we expect will continue to be, driven by our clinical development and manufacturing activities, compensation and related expenses, other regulatory expenses and general overhead costs. We expect our cash expenditures to increase in the near term as we fund our ongoing clinical development of Egalet-001 and Egalet-002, and continue to build-out our commercial manufacturing capability.

• Revenue: Revenue increased from zero for the three months ended September 30, 2013 to $346,000 for the three months ended September 30, 2014, as a result of the amortization of deferred revenue and certain research and development services performed under Egalet's collaborative agreement with Shionogi.

• R&D Expenses: Research and development expenses increased to $6.3 million for the three months ended September 30, 2014 from $1.1 million for the three months ended September 30, 2013. The increase of $5.2 million was driven primarily by an increase in our development activities for Egalet-001 and employee and stock-based compensation expenses. 

• G&A Expenses: General and administrative expenses increased to $4.2 million for the three months ended September 30, 2014 from $1.3 million for the three months ended September 30, 2013. The increase was primarily attributable to the increase in employee compensation and stock compensation expense of $1.8 million related to hiring of personnel and the adoption of a stock compensation plan and professional fees of $700,000 related to the establishment of our U.S. office.

• Interest Income (Expense): Interest income increased to $5,000 for the three months ended September 30, 2014 from an expense of $3.1 million for the three months ended September 30, 2013. This change was primarily attributable to the $3.1 million in interest expense recognized in 2013 related to the accretion of the beneficial conversion feature that was recorded in connection with our April 2013 convertible debt issuance and the accretion of the premium that we recorded in connection with our August 2013 convertible debt issuance.

• Net Loss: Net loss increased to $10.2 million for the three months ended September 30, 2014 from a net loss of $5.5 million for the three months ended September 30, 2013. 

Upcoming Milestones

• 2014 Q4: Complete enrollment of Category 3 abuse-deterrent study for Egalet-001;
• 2014 Q4: Initiate Category 3 abuse-deterrent study for Egalet-002;
• 2015 Q1: Begin enrollment of Egalet-001 Phase 3 study; and
• 2015 Q1: Initiate pivotal Phase 3 efficacy and safety trials for Egalet-002.

Conference Call Information

Egalet's management will host a conference call to discuss the third quarter 2014 financial results:

About Egalet
Egalet's mission is to help ensure access to effective medications for individuals living with chronic pain while protecting physicians, families and communities from the burden of abuse. Prescription opioid abuse has reached epidemic levels in the United States, with 6.8 million current prescription drug abusers and drug abuse is now the leading cause of accidental death in the United States. With the majority of opioids abused in the United States originating from a prescription and most often coming from a friend or family, a safeguard against the unexpected is needed. Egalet is committed to bringing peace of mind to the patients and physicians it serves by offering abuse-deterrent pain medications. Using the proprietary Guardian Technology the Company has a pipeline of clinical-stage, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The Guardian Technology is customized to resist specific routes of abuse that often occur with the underlying active pharmaceutical ingredient. The Company's lead program, Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, is in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. It was designed to resist common methods of abuse, including one of the most common routes for morphine via injection. Egalet-001 which is in pivotal studies, if approved, could fill a significant unmet need in the marketplace. Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, is in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Egalet-002 was designed to resist common methods of abuse, including crushing and snorting the most common route of abuse for oxycodone. Egalet entered into a collaboration with Shionogi in November of 2013, to develop abuse-deterrent hydrocodone based products.

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