electroCore, Inc.

Greetings and welcome to ElectroCorps First Quarter 2022 Earnings Conference Call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Rich Cockrell. Thank you. You may begin.

Thank you all for participating in today's ElectraCore's earnings call. Joining me today are Dan Goldberger, Chief Executive Officer, Brian Posner, Chief Financial Officer, and Dr. Peter Stotz, ElectraCore's Chief Medical Officer. Earlier today, ElectraCore released results for the first quarter ended March 31st, 2022. A copy of the press release is available on the company's websites. Before we begin, I'd like to remind you that management will make statements during the call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including without limitation, Our examination of operating trends and our future financial expectations are based upon the company's current estimates and various assumptions. These statements involve material risk and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements or lists of risks and uncertainties associated with the company's business Please see the company's filings with the Securities and Exchange Commission. Electric Corps disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information that is accurate only as of the live broadcast today, May 5, 2022. And with that, I'll turn the call over to Dan. Go ahead, Dan.

Thank you, Rich. Hello, everybody, and thanks for joining us on today's call. Our U.S. business performance was solid in the first quarter and in March 31, 2022, more than making up for a slow start in our United Kingdom business. Revenue for the first quarter of 2022 hit a record $1.9 million last increasing approximately 58% over the first quarter of 2021, and approximately 27% sequentially. Gross margins expanded to 81%, and net cash used in operations was about $4.8 million for the quarter ended March 31, 2022. Our U.S. cash pay commercial headache channels are starting to accelerate, and we expect to continue those initiatives through the rest of 2022. We currently have about 345 active prescribers in our GC direct program that allows a prescriber to send a prescription directly to our home office for processing by our customer experience team. We work directly with the patient to dispense therapy and collect payment. We have an additional 52 prescribers in our G concierge program, a physician dispense model where the prescriber purchases inventory from ElectriCorps at a transfer price and provides therapy directly to their patient from their own inventory. E-commerce channels we established in January 2022 are off to a good start. Consumers can go to our website, fill out a questionnaire that is adjudicated by a telehealth process, obtain a prescription, and then move therapy into a shopping cart to obtain a GammaCore Sapphire for their own personal use. Our customer experience team is available to patients in all of these channels, providing training and support for new prescriptions, and following up with patients to ensure they are staying in compliance with their therapeutic protocol. We plan to continue investing in our digital awareness campaigns, initially through paid search and social media, in an effort to drive headache patients to our various channels in the United States and the United Kingdom. Net revenue from the U.S. commercial headache channel was $277,000, for the quarter ended March 31, 2022, a 90% increase from $145,000 in the first quarter of 2021. Approximately $254,000 of our U.S. commercial revenue in the first quarter came from cash pay programs. Net sales from the Department of Veterans Affairs, or the VA, and Department of Defense, or DOD, were $1.3 million, an increase of 86%, as compared to $679,000 in the first quarter of 2021. A total of 105 VA and DOD military treatment facilities have purchased Damacor products through March 31st, 2022, as compared to 79 through the first quarter of 2021. Note that there are approximately 1,300 VA healthcare hospitals and clinics and over 400 military hospitals and medical clinics. so we still have plenty of potential growth ahead of us. Revenue from channels outside the United States decreased 20% to $305,000 in the first quarter of 2022, as compared to $380,000 for the first quarter of 2021. Our UK business was affected by the resurgence of COVID, which severely impacted access to headache clinics in January and February. We saw some recovery in March, and April has been encouraging. We look forward to returning to growth in this channel in the second quarter and for the rest of 2022. On April 5, 2022, we announced an exclusive license agreement with Taysian Limited for Japan. The license covers our proprietary non-invasive vagus nerve stimulation technology for headache and provisions to expand to additional indications and or territories in the future. Taysian will be responsible for the regulatory process in Japan at Taysian's expense. with support from ElectriCorps and leveraging previously published pivotal data. The initial license fee will be recognized over the next four quarters, starting in the current quarter, ending June 30th, 2022. The agreement provides for additional license payments tied to successful completion of regulatory and commercial milestones in the future. It also requires an annual license fee that will come due every year, starting in April of 2023. In addition to the cash consideration, this license agreement further validates the long-term commercial opportunities for NVNS therapy around the world. On April 19, 2022, we announced that GammaCore noninvasive vagus nerve stimulation has been selected for additional funding by the Department of Defense Biotech Optimized for Operational Solutions and Tactics, or BOOST program, The BOOST research program, which will be conducted under the leadership of the 711th Human Performance Wing Optimization Branch of the United States Air Force, seeks to optimize and validate the efficacy of NVNS in accelerated training, sustained attention, reduced fatigue, and improved mood among Air Force personnel. Should the BOOST program confirm previous findings? The project schedule calls for electric core to supply field-ready devices to the Air Force in the second half of 2023. We're optimistic that the solution we ultimately provided to the Air Force will also find favor among other branches of the active military in the future. Now turning to our clinical progress, we continue to advance NDNS across several trials. We participated in a pre-submission meeting with the FDA on May 2nd, 2022, where we discussed our plans in post-traumatic stress disorder, or PTSD, mild traumatic brain injury or concussion, NBNS as a bridge therapy for inpatient substance abuse programs, and acute stroke, among other topics. We believe our presentation was well received, and we have several follow-up items to pursue. In February this year, data was presented at the International Stroke Congress, suggesting that NBNS therapy could be an effective acute intervention for ischemic or hemorrhagic stroke. A subsequent larger trial, NOVIS, is more than 50% enrolled towards a 150-patient target. Novus is on track to complete enrollment early next year. Stroke data is exciting, as there are relatively few acute interventions approved for treating stroke and none that can be deployed before an ischemic hemorrhagic determination has been made. NVNS could be a very exciting new tool in fighting this debilitating condition. We look forward to the anticipated full publication of the TRBNS study in a peer-reviewed journal later this year. On January 12th, 2022, we announced that Gamma Corp NBNS received breakthrough designation from the US Food and Drug Administration, or FDA, for the treatment of PTSD, a highly prevalent and disabling disorder with limited approved treatment options. We will schedule a sprint meeting with the agency shortly based on what we learned in our May 2nd, 2022 pre-submission discussion. Now, I'd like to turn the call over to Brian for a review of our financials and other guidance items. Brian?