electroCore, Inc.

Greetings, ladies and gentlemen, and welcome to the MetroCorp's smooth quarter 2020 earnings copy webinar. Currently at this time, all participants on the list will be known. Mayor will conduct a question and answer session, and instructions will follow at that time. Also a reminder that this conference call is being recorded. At this time, I'd like to turn the call over to your host, Tom Richum of LifeSide Drivers. Please go ahead, sir.

Thank you, Operator, and thank you all for participating in today's call. Joining me are Dan Goldberger, Chief Executive Officer, Brian Posner, Chief Financial Officer, and Dr. Peter Stotz, ElectriCorps' Chief Medical Officer. Earlier today, ElectriCorps released results for the quarter and year ended December 31, 2020. 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 this 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, 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 risks and uncertainties that could cause actual results or events to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with the company's business, please see the company's filings with the Securities and Exchange Commission. Electric Cord 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 11th, 2021. And with that, I'll now turn the call over to Dan.

Thank you, Hans. Hello, everybody, and thank you for joining us today. Full year 2020 revenue was $3.5 million, the upper end of our previously provided guidance range of $3.3 to $3.5 million. Furthermore, net cash used for the full year decreased 55% to $20.2 million for the full year 2020 from $44.5 million for the full year 2019. Brian will cover the financials in detail, but I want to begin with a few highlights. For the full year 2020, total revenue of $3.5 million increased approximately 46%, as compared to $2.4 million for the full year 2019. We're pleased that the aggressive restructuring activities in 2019 and 2020 drove growth across our key revenue generating channels in spite of COVID-19 pandemic headwinds. During the fourth quarter of 2020, 2,647 total paid months of therapy were utilized across our three revenue generating channels, resulting in net sales of $928,000. A sequential decline from 2,881 paid months of therapy in the third quarter of 2020, largely due to the third wave of COVID. The Federal Supply Schedule, or FSS, which encompasses the VA, DOD, and other government and military agencies, continues to be our most important revenue channel. During the fourth quarter of 2020, 71 Department of Veterans Affairs and Department of Defense military treatment facilities purchased Gamma Corps products as compared to 68 during the third quarter of 2020 and 54 during the fourth quarter of 2019. Also, during the fourth quarter of 2020, the company shipped approximately 1,232 paid months of therapy pursuant to VA and DOD originating prescriptions. compared to 1,571 paid months of therapy during the third quarter of 2020 and 829 during the fourth quarter of 2019. Fourth quarter sales and paid months of therapy to VA and DOD facilities continue to be impacted by the ongoing COVID-19 pandemic, which saw case counts surge in many parts of the country in Q4 2020. Our sales and marketing function continues to leverage telehealth, and other virtual capabilities, and management believes that the company remains well positioned to resume normalized outreach activities as the pandemic subsides. Turning now to the United Kingdom and other OUS territories. During the fourth quarter of 2020, ElectriCorps shipped approximately 1,143 paid months of therapy outside of the United States, as compared to 1,020 paid months of therapy during the third quarter of 2020, and 961 during the fourth quarter of 2019. Revenue generated outside the U.S. was $311,000 in the fourth quarter of 2020 as compared to $278,000 in the third quarter of 2020 and $294,000 in the fourth quarter of 2019. We were pleased to see a sequential increase in paid months of therapy driven mostly by the U.K., which has been and continues to be hit very hard by the pandemic. During the fourth quarter of 2020, we announced that Gamma Corps would continue to be reimbursed in England under the NHS Innovation and Technology Payment Program, ITPP, for the treatment of cluster headache in adults for an additional six months through March 2021. With the January notification that Gamma Corps was selected for inclusion in a new long-term reimbursement policy called NHS Improvement MedTech Funding Mandate Policy 2122. We are confident that broad NHS England coverage will remain as our team works with NHS England to transition from the ITPP to the MedTech Funding Mandate Policy. In short, the policy supports commissioners and providers in the use of selected National Institute for Health and Care Excellence, or NICE, approved clinically effective and cost-saving medical devices, diagnostic and digital technologies that will improve patient outcomes. A projection by NICE concludes that more widespread adoption of GammaCore as an adult cluster headache therapy could deliver cost savings to NHS of as much as 4.6 million pounds sterling over the next five years. We're grateful to NHS for their ongoing support of cutting-edge therapies such as GammaCore. Similarly, we learned in January that Health Improvement Scotland, or HIS, has published a Scottish Health Technology Group, SHTG, adaptation for NHS Scotland on the use of GammaCore for cluster headache. The SHTG adaptation is now being disseminated across NHS Scotland health boards to inform the use of GammaCore for cluster headache. In February 2021, we also learned that GammaCorp's listing in the NHS supply chain catalog has been extended for an additional two years through June 3, 2023. The NHS supply chain helps NHS deliver clinically assured quality products at the best value to its patients, and the inclusion of GammaCorp in the catalog allows hospitals to purchase GammaCorp Sapphire for their primary headache patients, taking into account their own budgetary restrictions. The listing of GammaCore Sapphire as an eDirect product marks an important milestone in the company's provision of its medical technologies to UK patients in an easier, cost-effective way. In recent months, we took meaningful steps to expand GammaCore's global availability. In December, we announced an exclusive distribution agreement with Pro Medical Baltic to distribute GammaCore in Eastern Europe, including Lithuania, Latvia, Belarus, Kazakhstan, and Ukraine. In January, we entered into a similar agreement with RSK Medical in Canada, and most recently in March, we announced an agreement with Medistar, who will serve as the exclusive distributor for non-invasive vagus nerve stimulation in Australia. We expect to expand our global network with leading medical technology distribution partners to make GammaCore more broadly available outside the USA. We continue to make measured investments in our commercial channel in the United States, most notably through negotiations with national and regional insurers and pharmacy benefit managers for the purpose of expanding the population of gamma-core-covered lives. In January 2021, we announced that CMS published its most recent Level 2 Healthcare Common Procedure Coding System, commonly known as HCPCS, establishing a unique code K1020 for noninvasive vagus nerve stimulator. The coding decision covers the GammaCore Sapphire G and is in response to the application that we submitted during CMS' second biannual 2020 coding cycle for non-drug and non-biological items and services. That application focused on the clinical and economic advantages of GammaCore therapy. All final coding decisions for the second biannual 2020 coding cycle for non-drug and non-biological items and services will go into effect on April 1, 2021. We view the establishment of a unique HCPCS code for noninvasive vagus nerve stimulation as an important differentiator from other nerve stimulator technologies and a potentially significant driver of additional coverage within the medical benefit pathway. We still have a lot of market access work to do and remain optimistic that the unique code will contribute to meaningful commercial reimbursement wins in the future. On the topic of the COVID-19 pandemic, our employees in Rockaway, New Jersey, and in the field continue to implement best practices for preserving the safety and health of all of our stakeholders. The FDA Emergency Use Authorization, or EUA, that was granted to us in July 2020 for the use of Gamma Core Sapphire CV at home or in a healthcare setting for the acute treatment of adult patients with known or suspected COVID-19 continues to generate clinician interest. GammaCore Sapphire CV is available throughout our BADOD channels to hospitals directly from the company, through Premier Specialty Pharmacy by obtaining a prescription from a patient's healthcare provider, or through a telehealth consult powered by our telehealth partner, Upscript LLC. We've also set up an online portal for patients to use, www.getgammacore.com. While prescriptions generated through the EUA were not a meaningful source of revenue during the fourth quarter, we continue to be pleased with the interest that it is generating in NVNS as a viable therapy. At this point, I want to ask our Chief Medical Officer, Dr. Peter Stotz, to provide an update on our various clinical initiatives.