Dan Goldberger
Analyst · Ladenburg Thalmann
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 2021. $1.6 million of our US commercial revenue in 2022 came from cash pay programs as compared to $310,000 for 2021. We have several initiatives in the US Commercial Channel, which continue to grow in terms of revenue and number of prescribers. Our cash pay clinician dispense programs, gCDirect 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 Truvaga, our direct-to-consumer wellness product for stress, anxiety and sleep available online without a prescription at truvaga.com. We're pleased with the early performance of Truvaga, which has generated sales of almost $100,000 in January and February, 2023. On future earnings calls, we'll provide additional metrics around the Truvaga product line, but the soft launch so far has greatly exceeded our expectations. During the year, we also announced a distribution agreement with Joerns Healthcare, LLC that we believe will add more than 12.5 million covered lives within its select managed care health system. The business model with Joerns will be similar to how we work with the VA hospital system. Joerns will handle adjudications, billing and collections, while electroCore will ship directly to patients and provide in-servicing and patient support. Joerns will pay electroCore for devices dispensed. We continue to work with Joerns 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 gammaCore 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 19, 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've signed an agreement with the prime contractor and received our first purchase commitments under that contract. We are establishing the TAC-STIM brand of nVNS 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, TAC-STIM 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 IDA where we discussed the pivotal trial to support future regulatory submission for an indication to treat the symptoms of substance withdrawal. And IDA 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 and 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?