electroCore, Inc., a commercial-stage bioelectronic medicine company, today provided an operating and business update as well as select unaudited financial guidance for the third quarter.
“During the third quarter, we again demonstrated our ability to adapt to a rapidly changing business environment and maintain our focus despite the ongoing pandemic, resulting in a greater than 35% sequential increase in total revenue to more than one million dollars,” stated Dan Goldberger, Chief Executive Officer of electroCore. “Our key revenue channels, notably the VA/DoD and United Kingdom, continued to perform well. While our COVID-19 initiatives did not contribute material revenue during the quarter, our physician and patient outreach efforts under our Emergency Use Authorization are ongoing. We are also very pleased that the VA is sponsoring a study of gammaCore Sapphire in veterans with co-morbid traumatic brain injury and Post-Traumatic Stress Disorder. This work could lead to another potentially high-value indication for nVNS. We believe we are well positioned to finish the year and to enter 2021 with renewed momentum across all of our revenue channels.”
COVID-19: The launch of gammaCore Sapphire™ CV for treatment of known or suspected COVID patients under the previously announced Emergency Use Authorization is proceeding. gammaCore Sapphire CV is available by prescription through our VA/DoD channels, from Premier Specialty Pharmacy, and access to telehealth consults from health care providers are being offered through the UpScript telehealth portal at www.getgammacore.com. We are pleased with the level of interest this initial launch has generated for both gammaCore Sapphire CV as well as our headache products. As our understanding of the disease has evolved and in-patient treatment regimens have changed, the enrollment criteria for SAVIOR 1 and SAVIOR 2 trials in hospitalized COVID patients have proven to be more challenging than originally anticipated. We continue to monitor COVID-19 levels near the two sites conducting the study and are discussing possible modifications to the protocol with the Investigators.
Federal Supply Schedule: During the third quarter of 2020, 68 Department of Veterans Affairs (VA) and Department of Defense (DoD) military treatment facilities purchased gammaCore™ products as compared to 67 during the second quarter of 2020, 64 during the first quarter of 2020, 54 during the fourth quarter of 2019 and 48 during the third quarter of 2019. Also, during the third quarter of 2020, the company shipped approximately 1,600 paid months of therapy pursuant to VA and DoD originating prescriptions, compared to 988 paid months of therapy in the second quarter of 2020, 1,084 paid months of therapy during the first quarter of 2020, 829 during the fourth quarter of 2019 and 553 during the third quarter of 2019.
In light of the ongoing COVID-19 pandemic, the company’s ability to visit VA doctors and facilities remains limited. However, the VA quickly and effectively adopted telehealth capabilities, with the number of daily sessions increasing more than 10x since the start of the pandemic, according to a news release from the Office of Public and Intergovernmental Affairs. The company continues to navigate through this challenging business environment and remains well positioned to resume all available outreach activities if and when the pandemic subsides.
Outside of the U.S.: During the third quarter of 2020, electroCore shipped approximately 1,020 paid months of therapy outside of the United States, as compared to 938 paid months of therapy during the second quarter of 2020 and 1,008 during the first quarter of 2020.
Since April 2019, gammaCore has been reimbursed by NHS England’s Innovation and Technology Payment (ITP) Program for the treatment of cluster headache in adults. The ITP Program is designed to support the adoption of innovations and technologies in the NHS market through the removal of significant financial barriers for both commissioners and providers. Earlier this month, the ITP Program for gammaCore was again extended for a six-month period through March 1, 2021 with the option for three additional years. The total contract value, assuming exercise of the three-year option, could be up to approximately $4.6 million at recent exchange rates. Perhaps more importantly, the company views this extension as another meaningful validation of nVNS technology. More than 55,000 adults in the U.K. suffer from cluster headache, a truly debilitating condition with few effective treatment options.
Commercial: During the first half of 2020, the company restructured and streamlined its commercial distribution channel. All of the inventory placed in the commercial channel during 2019 was fully dispensed by June 30, 2020. As a result, the company was able to recognize a full quarter of replenishment orders during the period ended Sep 30, 2020. The company is monitoring pharmacy inventory on an ongoing basis and expects ongoing contribution from commercial replenishment orders in the coming quarters.
mTBI/PTSD VA Study. In the quarter ended September 30, 2020, the company was notified that the VA has agreed to sponsor a quadruple blind, randomized, sham-controlled clinical trial of nVNS as a potential treatment for mild traumatic brain injury (mTBI) and Post-Traumatic Stress Disorder. The trial is being sponsored by the VA‘s Office of Research and Development at the Atlanta VA Medical Center. mTBI and PTSD are of significant concern for the VA in light of recent conflicts in Iraq and Afghanistan, and it is estimated that up to 56% of mTBI patients have co-morbid PTSD, making the combined conditions more common than each individually. This is an important study for the company with the potential to introduce gammaCore in an entirely new indication and further leverage the company’s existing relationship with the VA.
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.