electroCore, Inc.

to ElectroCore full year 2021 earnings conference call. At this time, all participants are in 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, and over to you, sir.

Thank you all for participating in today's ElectroCorps earnings call. Joining me on the call today are Dan Goldberger, Chief Executive Officer, Brian Posner, Chief Financial Officer, and Dr. Peter Stotts, ElectroCorps' Chief Medical Officer. Early today, ElectroCorps released results for the fourth quarter and full year ended December 31st, 2021. 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 that include forward-looking statements within the meaning of 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 fact 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. For a list of risk and uncertainties associated with the company's business, please see the company's filings with the Securities and Exchange Commission. ElectroCorps 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 March 10th, 2022 at 4 30 PM Eastern standard time. And with that, I'll turn the call over to Dan.

Thank you, Rich. Hello everybody. And thank you for joining us on today's call. I'm pleased to report that our dedicated team continues to dramatically improve our operating results while advancing so many new opportunities for a proprietary non-invasive vagus nerve stimulation therapy. We've implemented several new initiatives that we expect will generate strong results during 2022 and beyond. Full year 2021 revenue was a record $5.5 million, increasing 56% over $3.5 million in 2020. Gross margins expanded to 76%, and net cash used in operations decreased to $13.6 million for the full year 2021. Entering 2022, our business is more efficient, scalable, and positioned for accelerating growth. Pharmacy benefit managers, or PBMs, including CVS, Caremark, and Express Scripts, continue to adjudicate insurance benefits for an estimated 12 million covered lives and provide gamma-core therapy to patients that have a high-end benefit design that does not differentiate between drugs and devices. These patients are subject to a copay of between $25 and $75 per month, depending on their specific benefit plan. Even for these patients, we find that more than 60% of our patients going through the specialty pharmacy to have their pharmacy benefits adjudicated ultimately pay cash because the patient has not yet met deductible or copay obligations or because their benefit design does not yet reimburse for noninvasive vagus nerve stimulation therapies. We've established three new cash pay commercial channels in recent months to improve access for patients that are willing to pay for therapy. First, GC Direct 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. G-Concierge, it's a physician dispense model under which the prescriber purchases inventory from ElectriCorps at a transfer price and provides therapy directly to their patient from their own inventory. And third, we launched e-commerce storefronts in the United States and United Kingdom where consumers can go to our website, fill out a questionnaire that is adjudicated by a telehealth process, obtain a prescription, and then move therapy seamlessly into a shopping cart that is dispensed directly to a patient. Our world-class customer experience team is available to patients in all of these channels, providing training and support for new prescriptions and sending reminders about refill prescriptions. During 2022, we plan to further invest 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. We expect that these new channels and campaigns can significantly increase awareness and streamline availability of NVNS therapy for patients, many of whom have historically been encumbered by reimbursement and physician access challenges. Net sales of $858,000 in the fourth quarter of 2021 from our government channels, including the Department of Veterans Affairs and Department of Defense Hospitals, increased 69% as compared to $509,000 in the fourth quarter of 2020. Full year 2021 net sales from the VA and DOD grew 61% to approximately $3.3 million, as compared to net sales of approximately $2 million for the full year 2020. A total of 100 VA and DOD military treatment facilities have purchased Gamma Corps products through December 31, 2021. as compared to 71 in 2020. Note that there are approximately 1,300 VA healthcare facilities and over 500 military hospitals and medical clinics, so we still have plenty of growth ahead of us. Revenue from channels outside the United States increased 36% to $1.5 million in 2021 as compared to $1.1 million for the full year 2020. We look forward to continued revenue growth in the UK as the MedTech funding mandate continues to roll out and we expand the indications available through the United Kingdom e-commerce site. Net revenue from the U.S. commercial headache channel was $679,000 for 2021 as compared to $358,000 in 2020. Approximately $321,000 of our U.S. commercial revenue in 2021 came from cash pay programs. Going forward, our US sales function will be focused on the following four revenue growth initiatives. Number one, going deeper into our 100 existing VA hospital customers. Number two, leveraging our VA hospital success to open new VA hospital customers. Number three, recruiting additional commercial prescribers to our cash pay business models while we work towards broader commercial insurance coverage. And number four, increasing our direct-to-consumer advertising spend to build awareness and demand. We've grown our U.S. sales function in recent months within our customer experience team, territory business managers in the field, and sales agents. We look forward to reporting accelerating growth within the United States channels. While focused on commercializing our broad headache indications, we continue to advance future applications of NVNS across several clinical trials, regulatory submissions, as well as in our intellectual property estate. In February 2022, data was presented at the International Stroke Congress suggesting that NVNS therapy could be an effective acute intervention for ischemic or hemorrhagic stroke. In the TR venous trial, 69 acute stroke patients were randomly assigned to three treatment arms, sham, low-dose, and high-dose NVNS. The study met its primary safety objective and all secondary safety and feasibility endpoints. Relative infarct growth measured by diffusion-weighted imaging in the high-dose NVNS group was lower than in the sham group with a p-value of 0.05 against baseline. A subsequent larger trial called NOVIS is more than 50% enrolled towards a 150-patient target and should be fully enrolled by early 2023. These early data are 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 publication of the stroke data in a peer-reviewed journal later this year. On January 12, 2022, we announced Gamma Corps NVNS received breakthrough designation from the U.S. Food and Drug Administration, or FDA. for the treatment of post-traumatic stress disorder, or PTSD, a highly prevalent and disabling disorder with limited approved treatment options. Research from an Emory Georgia Tech team showed a 31% reduction of symptoms of PTSD, as well as changes in the inflammatory cytokine IL-6 when compared to sham stimulation. The ability of NVNS to target the underlying causes of PTSD supports its potential as a breakthrough treatment for PTSD. We look forward to scheduling a breakthrough device sprint meeting with the FDA in coming months to discuss the regulatory pathway for NVNS therapy to treat the symptoms of PTSD. FDA offers sprint discussions to support sponsors needing a timely resolution of potentially novel issues within a set time period, for example, 45 days. During a sprint discussion, the sponsor may provide additional information or revisions to initial proposals. We also plan to request pre-submissions meeting with the FDA to discuss NVNS for opioid use disorder, traumatic brain injury, and Parkinson's disease, among other possible indications we will evaluate later this year. A pre-sub provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission. A pre-sub is appropriate when FDA's feedback on specific questions is necessary to guide product development and or submission preparation. Recently, Lancet Neurology published a review highlighting the potential role of non-invasive neurostimulation approaches for Parkinson's disease, a progressive neurodegenerative disorder. One study cited in the review found that patients who received active stimulation had significant improvements in both non-motor, especially cognitive, and motor symptom burden scores compared with patients who received sham stimulation. We are encouraged by the growing amount of data supporting the role of NBNS as a plausible therapeutic option for Parkinson's disease. In addition to our ongoing clinical and regulatory activities, we have also been investing in and building on our strong intellectual property portfolio. Last year, we announced two new patents issued by the United States Patent and Trademark Office. is related to the treatment of stroke symptoms and methods for treating the acute symptoms of stroke or transient ischemic attack. The second patent is related to devices, systems, and methods integrated with smartphones that allow patients to self-treat medical conditions such as migraine headache by electrical, non-invasive stimulation of nerves. The specific patent is the eighth U.S. patent issued to us in the company's mobile connectivity platform with additional U.S. and international matters pending. We will continue building an intellectual property portfolio around smartphone-connected noninvasive therapy. This may provide a foundation for combining the company's clinically proven therapy with digital health platforms that could enable healthcare providers to use remote patient monitoring or remote therapeutic monitoring reimbursement codes. That combination, in turn, may enable future business models as well as expand revenue streams for the company's products. Earlier this week, we announced a few changes to our board of directors. Dr. Steven Andra has resigned effective March 4, 2022, and Mike Attia has notified us that he will serve out his remaining term but not stand for re-election at our annual general meeting later this year. Both directors will remain available to the chairman and CEO as advisors, and we greatly appreciate their long, dedicated service to ElectroCorp. I'm thrilled to announce the two fine executives, Ms. Julie Goldstein and Ms. Tricia Wilber, have agreed to join our Board of Directors effective March 15, 2022. Ms. Goldstein and Ms. Wilber have had tremendous success building direct-to-consumer businesses, and we look forward to bringing their expertise to Electric Court. Now, I'd like to turn the call over to Brian for a review of our financials and other guidance items. Brian?