Egalet Corporation
Egalet Corporation (EGLT) is a fully integrated specialty pharmaceutical company developing, manufacturing and commercializing innovative treatments for pain and other conditions. Given the need for acute and chronic pain products and the issue of prescription abuse, the company focused on bringing non-narcotic and abuse-deterrent (“AD”) opioid formulations to patients and physicians. Egalet is currently marketing ARYMO® ER (morphine sulfate) extended-release (“ER”) tablets, for oral use CII (“ARYMO ER”), SPRIX® (ketorolac tromethamine) Nasal Spray (“SPRIX Nasal Spray”), and OXAYDO® (oxycodone HCI, USP) tablets for oral use only—CII (“OXAYDO”).1
ARYMO ER, an ER morphine product formulated with abuse-deterrent properties and approved 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, is its first product developed using its proprietary Guardian™ Technology. Egalet acquired, and became obligated to pay royalty payments under a preexisting license of, SPRIX Nasal Spray, the first and only approved nasal spray formulation of a nonsteroidal anti-inflammatory drug (“NSAID”), used for short‑term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Egalet also licensed OXAYDO, an immediate-release (“IR”) oral formulation of oxycodone designed to discourage intranasal abuse, which is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
In June 2017, Egalet secured a contract with one of the largest payers in the United States (“U.S.”) that will provide coverage of ARYMO ER to more than 24 million of its member lives. Egalet believe that this contract will enable it to remove barriers to access to ARYMO ER for the applicable healthcare providers and the patients they treat.
Also in June 2017, Egalet entered into a two-year agreement with Ascend Therapeutics ("Ascend") to co-promote SPRIX Nasal Spray to more than 9,000 women's healthcare practitioners. The agreement, set to begin in the third quarter 2017, will enable it to avail itselves of the 37-person Ascend sales team to promote SPRIX Nasal Spray to healthcare practitioners in women's health.
Its supplemental new drug application (“sNDA”) for OXAYDO to support an abuse-deterrent label claim for the intravenous route of abuse has been accepted by the Food and Drug Administration (“FDA”) and had a goal date of March 30, 2017. The FDA is still reviewing the file and an action is pending. The sNDA includes data from a battery of Category 1 in vitro abuse-deterrent studies that was presented at the PAINWeek conference in September 2016. On June 20, 2017, Egalet received a complete response letter (“CRL”) from the FDA regarding a prior approval supplement (“PAS”) for OXAYDO® 10 mg and 15 mg dosage strengths. The FDA has requested more information regarding the effect of food on OXAYDO 15 mg and the intranasal abuse-deterrent properties of OXAYDO 10 mg and 15 mg. Egalet intend to work with the FDA to determine the path forward.
Beyond its commercial programs, Egalet has a pipeline of products developed using its Guardian Technology. Egalet-002, an AD, ER, oral oxycodone formulation, is currently in Phase 3 studies and in development for the same indication as ARYMO ER. Egalet has determined to delay indefinitely its previously-announced anticipated 2019 filing date for the Egalet-002 New Drug Application. Egalet also have Egalet-003, an AD stimulant, and Egalet-004, an AD, ER hydrocodone, which were developed using its Guardian Technology. Egalet is seeking partners for all of its product candidates.
Egalet continue to focus its business development on augmenting its product portfolio through potential in-licenses and product acquisitions; enhancing the opportunities for its existing products through partnerships that access physicians and patients outside of its commercial focus in the U.S. or markets outside the U.S.; and developing partnerships to leverage its Guardian Technology by collaborating on its current product candidates or exploring new product opportunities. Financial Operations
Its net losses for the three months ended June 30, 2016 and 2017 were $23.8 million and $26.5 million, respectively, and $42.3 million and $51.9 million for the six months ended June 30, 2016 and 2017, respectively. Egalet recognized revenues in the three months ended June 30, 2016 and 2017 of $3.5 million and $6.3 million, respectively, and $6.1 million and $11.7 million for the six months ended June 30, 2016 and 2017, respectively. As of June 30, 2017, Egalet had an accumulated deficit of $277.8 million. Egalet expect to incur significant expenses and operating losses for the foreseeable future as Egalet incur significant commercialization expenses as Egalet continue to grow its sales, marketing and distribution infrastructure to sell its commercial products in the U.S.
Until Egalet become profitable, if ever, Egalet will seek to fund its operations primarily through public or private equity or debt financings or other sources. Other additional financing may not be available to it on acceptable terms, or at all. Its failure to raise capital as and when needed could have a material adverse effect on its financial condition and its ability to pursue its business strategy. If Egalet is unable to raise capital when needed or on attractive terms, Egalet could be forced to delay, reduce or eliminate its research and development programs or any future commercialization efforts.
