electroCore Provides Business Update and Select First Quarter 2020 Guidance - Seite 2

FSS encompasses over 10 million covered lives, some 400,000 of whom saw VA healthcare providers for headache in 2018. The Company’s U.S. sales function continues to focus on this channel, but its ability to visit hospitals and doctors during the pandemic has been limited. The VA system has an advanced telehealth capability and gammaCore therapy can be prescribed in a telehealth consult and delivered directly to the patient’s home, a potential competitive advantage while the hospital system is locked down. That said, it is difficult to forecast the trajectory of the business during this period.

Outside of the U.S.: During the first quarter of 2020, electroCore shipped 1,008 paid months of therapy outside of the U.S., up from 961 paid months of therapy in the fourth quarter of 2019 and 828 in the third quarter of 2019. On April 8, 2020, the company announced that the U.K.’s National Health Service (NHS) exercised its option to extend the Innovation and Technology Payment (ITP) Program through September 2020. As such, gammaCore will continue to be reimbursed for those patients in England who suffer from cluster headache and respond to therapy.

Clinical:
Premium II: Premium II is a company-funded study designed to support electroCore’s proposed expansion of the gammaCore label into migraine prevention. As previously reported, the company has suspended enrollment in this study to further conserve cash. The company has initiated necessary steps to close the Premium II clinical trial and assess the data that has been collected from the trial to this point. As a result, there are currently no company-funded studies that are ongoing.

It should be noted, however, that a number of investigator-initiated clinical trials of gammaCore in new indications are progressing, including in respiratory distress secondary to COVID-19. These trials are largely funded by third party grants, and the company intends to report results from these studies as they become available.

Financial guidance:
electroCore today introduced the following preliminary unaudited financial guidance for the first quarter ended March 31, 2020:

Revenue: Management anticipates total revenue for the first quarter ended March 31, 2020 to be in a range of $700,000 to $750,000.

As previously reported, management has suspended full-year revenue guidance until it can better understand the trajectory of the company’s business through the COVID-19 pandemic.

Q1 cash used in operations: During the first quarter, electroCore used approximately $8.4 million to fund its operations, as compared to $9.4 million in the fourth quarter of 2019. The first quarter of 2020 included use of cash of approximately $1.7 million for previously committed purchases of inventory. Remaining outlays for these inventory commitments are not material. The company expects its average quarterly cash burn to be significantly lower for the balance of 2020.