electroCore, Inc.

Hello, and welcome to the ElectroCore fourth quarter and full year 2022 earnings conference call webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Nicole Jones of CG Capital. Please go ahead, Nicole.

Thank you all for participating in today's ElectroCore earnings call. Joining me today are Dan Goldberger, Chief Executive Officer, and Brian Posner, Chief Financial Officer. Earlier today, ElectroCore released results for the fourth quarter and full year ended December 31, 2022. A copy of the press release is available on the company's website. 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 that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including without limitation any guidance, outlook, or future financial expectations, or operational activities and performance, are based upon the company's current estimates and various assumptions. These assumptions 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. For a list of the risks and uncertainties associated with the company's business, please see the company's filings with the Securities and Exchange Commission. Electra Cordis claims 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, March 8, 2023. With that, I'll turn the call over to Dan.

Thank you, Nicole. Hello, everyone, and thank you for joining us on today's call. We made great progress advancing non-invasive vagus nerve stimulation in 2022 for various uses. we reported record sales of $8.6 million for the year ended December 31, 2022, a 58% increase over the prior year, and record fourth quarter 2022 sales of $2.6 million. Gross margins expanded nicely to 81% for the full year 2022. Revenue from the US commercial channel was $1.7 million for the full year ended December 31, 2022, a 158% increase from $679,000 in the full year of 2021. $1.6 million of our U.S. commercial revenue in 2022 came from cash pay programs as compared to $310,000 for 2021. We have several initiatives in the U.S. commercial channel which continue to grow in terms of revenue and number of prescribers. Our cash pay clinician dispense programs, GC Direct and GConcierge, have grown from 218 prescribers at the end of 2021 to 1,328 by the end of 2022. In the fourth quarter, ended December 31, 2022, we added an additional 390 new prescribers, and our prescriber numbers continue to show strong growth through the first few months of 2023. We believe the increase in prescribers could be a leading indicator of future growth. In December 2022, we announced the launch of TrueVega, our direct-to-consumer wellness product for stress, anxiety, and sleep, available online without a prescription at TrueVega.com. We're pleased with the early performance of TrueVega, which has generated sales of almost $100,000 in January and February 2023. On future earnings calls, we'll provide additional metrics around the Truvega product line, but the soft launch so far has greatly exceeded our expectations. During the year, we also announced a distribution agreement with Jerns Healthcare LLC that we believe will add more than 12.5 million covered lives within a select managed care health system. The business model with Jerns will be similar to how we work with the VA hospital system. JIRNs will handle adjudications, billing, and collections, while ElectraCore will ship directly to patients and provide in-servicing and patient support. JIRNs will pay ElectraCore for devices dispensed. We continue to work with JIRNs on the implementation, and our field sales team will be responsible for educating clinicians within those managed care systems. Net sales from the government channel, including Department of Veterans Affairs, or the VA, the Department of Defense, or DOD, and other government departments were $5.2 million, an increase of 60% as compared to $3.3 million in the full year 2022. A total of 117 VA and DOD military treatment facilities have purchased Gamma Corps products through December 31, 2022, as compared to 100 through the fourth quarter of 2021. We anticipate continued growth in the number of facilities and penetration within those facilities through our customer experience team, territory business managers, and sales agents in the field. On April 19th, 2022, we announced that GammaCore non-invasive vagus nerve stimulation has been selected for additional funding by the Department of Defense Biotech Optimized for Operational Solutions and Tactics, or the BOOST program. The BOOST research program, which will be conducted under the leadership of the 711th Human Performance 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. More recently, we signed an agreement with the prime contractor and received our first purchase commitments under that contract. We are establishing the TACSTEM brand of NBNS for human performance to commercialize the product being developed under the BOOST program, and we're exploring ways to make our initial product offerings available to all branches of the active duty military and first responders in the United States and abroad. In 2022, TACSTEM product sales contributed $125,000 of the government channel revenue reported above. Revenue from channels outside the United States increased 7% to $1.6 million in the full year 2022, as compared to $1.5 million for the full year 2021. In 2022, $139,000 was attributed to licensing fees associated with the exclusive relationship for NVNS in Japan. Now, turning to our clinical progress on September 7, 2022, The company announced the publication of a peer-reviewed manuscript, Transcutaneous Cervical Vagus Nerve Stimulation Reduces Behavioral and Physiological Manifestations of Withdrawal in Patients with Opioid Use Disorder in the Journal Brain Stimulation, which was conducted with the support of Emory University and Georgia Tech University and sponsored by a grant from the National Institute on Drug Addiction. We subsequently participated in a pre-submission meeting jointly with the FDA and NIDA, where we discussed the pivotal trial to support a future regulatory submission for an indication to treat the symptoms of substance withdrawal. NIDA has indicated that they're likely to finance that pivotal trial in its entirety. On October 20, 2022, we announced data from an oral presentation at Neurocritical Care Society's 20th annual meeting held in San Antonio, Texas, on the possible role of GammaCore in the acute treatment of traumatic brain injury, or TBI. Additional work on the potential benefits of NVNS on TBI will be funded by an exploratory development research grant, an R21, from the National Institute of Neurological Disorders and Stroke. We will continue to provide updates about our pipeline and other opportunities. Now, I'll turn the call over to Brian for a review of our financials and other guidance items. Brian?