Dan Goldberger
Analyst · Ryan Zimmerman with BTIG. Please proceed with your question
Thank you, Hans. Hello, everyone, and thanks for joining us today. I'm going to begin with an operational update, before turning the call over to Brian to review our financial results. You'll recall that electroCore is in the early stages of commercialization of our proprietary gammaCore therapy for headache patients. Before getting into the specifics, however, I want to lead with an update on COVID-19 and both the challenges and opportunities that we are experiencing as a result of the ongoing pandemic. It goes without saying that, the continued health and safety of our employees and external constituents remains of utmost importance. electroCore currently qualifies as an essential business under New Jersey state guidelines and our operations remain active. We serve patients, who are managing cluster headache and migraine conditions and remain committed to ensuring that these vulnerable individuals have access to our non-invasive vagus nerve stimulation or nVNS gammaCore therapy to treat their headache pain. The company has responded to the crisis by developing and deploying a multifaceted set of operational and financial initiatives designed to minimize disruptions to our normal business activities, and preserve its ability to execute our long-term growth objectives. To protect the safety, health and well-being of employees, customers, suppliers and communities, we are following federal state and local guidelines, to ensure safety in all facilities, including increased frequency of cleaning and disinfecting, physical distancing practices, requiring most non-production-related team members to work remotely, where possible, business travel restrictions, cancellation of events and limitations on visitor access to our facilities. The company is manufacturing and shipping products on schedule and is managing its inventory and supply chain to minimize disruptions. While the pandemic has caused unprecedented disruptions in business activities across the globe, we're doing everything possible to continue to execute on our growth plans, including as I'll discuss in more detail in a moment continued traction in sales channels that are currently producing revenue, notably the Veterans Administration and the United Kingdom. At the same time, opportunities are emerging that we believe may allow us to leverage our proprietary nVNS therapy to assist patients suffering from symptoms brought on by the virus. We previously announced that we have submitted an emergency use authorization application or EUA to the FDA that if approved would permit the use of gammaCore therapy to treat respiratory issues in COVID-19 patients for the duration of the emergency. The EUA leverages our prior studies of nVNS in other respiratory indications, including the treatment or prevention of symptoms of reactive airway disease, which includes asthma, bronchoconstriction, exercise induced bronchospasm, and COPD in adults. They are currently CE Mark approved to market gammaCore in the European Union for those disorders. This together with preclinical work and past pilot studies that we have conducted, could support our hypothesis that nVNS maybe beneficial to COVID-19 patients. In Spain, Dr. Carlos Tornero of the Hospital Clínico Universitario de Valencia, has started enrolling an investigator-initiated trial, IIT of gammaCore in COVID-19 patients called SAVIOR a Study for Assessing Vagus Nerve Stimulation in COVID-19 Respiratory Symptoms. This is a randomized open-label study that is targeting 90 hospitalized patients with a confirmed diagnosis of or suspected presumed to be COVID-19 positive. The primary endpoint is the need for mechanical ventilation. Secondary endpoints include supplemental oxygen requirements, mortality, delay onset of ventilation and cytokine levels. To date, five patients have been enrolled. SAVIOR-2 is the first formal study examining nVNS as a treatment for COVID-19 symptoms in the United States, has been initiated by Dr. Tariq Cheema at Allegheny General Hospital, the flagship hospital of the Allegheny Health Network in Pittsburgh. This study, which is expected to enroll its first patient shortly, is planned to recruit 60 subjects in total. In these two studies, the investigators are hoping to see that nVNS can improve the condition of their patients with COVID-19 through either improved breathing or blunting the cytokine storm that is leading to the worsening of COVID-19 in many patients. Cytokines and use of supplemental oxygen will also be measured. Recruitment for these studies is likely to take several months as the number of subjects in hospital with COVID fluctuates based on the location and current level of spread in that environment. We're also in discussions with several other highly regarded health care institutions here in the United States to launch similar studies. Importantly, the results of these investigator-initiated studies, if favorable may potentially lead to an important new indication for our technology. Final comment on COVID-19, we recently announced that a paper entitled Use of Non-invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated With COVID-19: A Theoretical Hypothesis and Early Clinical Experience, has been published in a peer reviewed journal Neuromodulation: Technology at the Neural Interface. That paper is available via open access. Turning now to our operating results. By the end of the first quarter, more than 2,850 American physicians have written at least one gammaCore prescription, up from 2,735 at the end of the fourth quarter of 2019. This metric continues to demonstrate physicians' growing awareness of and comfort with the efficacy and safety of gammaCore therapy. During the first quarter of 2020, we had 20% sequential growth in paid months of therapy rising to 2,633 from 2,195 in the fourth quarter of 2019. Total revenue for the first quarter 2020 was $734,000 as compared to $675,000 in the fourth quarter of 2019. Total revenue for the first quarter 2020 was within the guidance range of $700,000 to $750,000 that we provided in our April 17 update. Consistent with prior quarter's revenue growth was driven primarily by our continued focus on two specific opportunities where we are reliably getting paid. First, the Federal Supply Schedule eligible entities, which encompass Veterans Administration Department of Defense, and Indian Health Service. And second, the United Kingdom's National Health Service. Beginning with the Federal Supply Schedule or FSS recall that FSS encompasses approximately 10 million covered lives some 400,000 of whom saw VA healthcare providers for headache, in 2018. Last year, we redeployed significant sales resources to focus on this important channel. And we continue to see positive growth in our key metrics, as a result. 64 Veterans Administration and Department of Defense military treatment facilities, purchased gammaCore products during the first quarter of 2020, as compared to 54, during the fourth quarter of 2019. Also, during the first quarter of 2020, the company shipped 1,084 paid months of therapy to VA and DoD facilities, up 31% from 829, during the fourth quarter of 2019. Growth in paid months of therapy led to a 20% sequential increase in revenue, from the VA and DoD to $454,000 in the first quarter of 2020 from $378,000, in the fourth quarter of 2019. We were on a solid sequential growth trajectory before the pandemic. But our access to physicians and their access to patients have been severely impaired, since mid-March. Importantly, we continued to sell into new facilities, including the bellwether facility, Walter Reed Medical Center, subsequent to the end of the quarter. Through April 2020 and the first week of May, paid months of therapy are relatively flat, compared to the first quarter. We shipped 374 months of therapy to DoD, VA facilities in April 2020, compared to an average of 361 per month, from January through March. That's despite the fact that the COVID-19 pandemic has impaired our ability to travel and our ability to gain access to prescribing physicians to the VA and DoD facilities. We started shipping gammaCore directly to patients earlier this year, which enables VA-based physicians to provide their patients a totally virtual experience, by hosting a telehealth console, prescribing gammaCore, delivering the therapy directly to the patient at home, who is subsequently trained on our web portal. We believe that our virtual engagement can be a competitive advantage over injected therapies, which require an in-person consultation with a health care professional. We're encouraged by our current performance, against a very challenging business environment. In recent days, we've seen a few hopeful signs that certain VA hospitals are planning to host in-person meetings, with our field sales staff and are starting to see patients in clinic. Regarding the United Kingdom, we previously reported that, the National Institute for Health and Care Excellence, in its final guidance, recommended the use of gammaCore for the acute and preventive treatment of cluster headache in adult patients, across the National Health Service. Additionally, the NHS has indicated to us that it will again extend the previously announced innovation technology payment program that program which was first extended through April 2020 has now been extended through September 2020 and makes gammaCore eligible for the new medtech funding mandate mechanism, which could lead to long-term sustainable reimbursement of gammaCore. We view these developments as important additional validations of the benefits of nVNS therapy in general and gammaCore specifically. During the first quarter of 2020, total revenue attributed to outside the U.S. decreased to $277,000 from $294,000 in the fourth quarter of 2019. The decrease in revenue is largely due to the timing of revenue recognition and currency exchange fluctuations. Paid months of therapy outside the U.S. in the first quarter of 2020, actually increased to 1,008 from 961, in the fourth quarter of 2019. Not surprisingly, the impact of the COVID-19 pandemic in the United Kingdom has put pressure on new patient starts. And that could affect our ability to grow revenue from the United Kingdom channel, in the remainder of this year. Turning now to our U.S. commercial activities, in the pharmacy benefit management and commercial payer channels, our distribution partners report continued slow growth in paid months of therapy. We experienced sequential growth in the first quarter. And that trend appears to have continued into April 2020. This cadence is notable because late last year, we reallocated sales resources away from the commercial channel. It's too early to conclude that the commercial channel has turned a corner. But our recent announcement that we gained access to millions of ESI lives, on a preferred basis is one potential driver of paid months of therapy. We'll provide a more comprehensive commercial update, in August. In terms of the clinical update we previously announced that, as an additional cost savings measure and in light of the FDA clearance in migraine prevention that received in March 2020, we made the difficult decision to terminate the Premium II study. While we are terminating early, we have collected a significant amount of data from the study prior to the termination, which we're in the process of analyzing. We note that while the original enrollment target in the study was 340 to 360 patients, we were ultimately able to enroll approximately 220 to 230 prior to termination. Even with the lower enrollment Premium II is the largest randomized controlled clinical trial of the device in migraine prevention in the United States. We look forward to seeing that data as we work to further penetrate the very large adult migraine prevention market. There are several other investigator-initiated trials of gammaCore, underway in addition to SAVIOR 1 in Spain and SAVIOR 2 in Pittsburgh that we discussed previously. These trials are exploring the use of gammaCore in indications that would be considered more exploratory. Still those studies speak to the potential broad clinical utility of non-invasive vagus nerve stimulation and we look forward to results from ongoing studies as they become available. In preparation for our shareholder meeting on June 12, 2020, I wanted to recap recent changes to our Board of Directors. We announced at the end of March that our Chairman, Carrie Cox would be stepping down from the Board effective April 1, 2020 and that directors Nick Colucci and Jim Tullis would be stepping down prior to the annual meeting. Carrie, Nick and Jim provided invaluable guidance to the company during a critical time in its evolution and I want to personally thank them for their service. Carrie was succeeded as Chairman by our current independent Board member Michael Atieh. We also announced the appointments of John Gandolfo, Thomas Patton, and Peter Cuneo effective April 2, 2020. John, Tom, and Peter are all proven organizational leaders with diverse medical device industry and turnaround experience that will serve us very well as we continue to execute on our more streamlined commercial plan. I look forward to their contributions. On the topic of our shareholder meeting among other things, we are asking shareholders to give the Board authority to implement a reverse split at some time in the future, if and only if, it becomes advisable to preserve our NASDAQ listing or to improve the liquidity of our common stock. While NASDAQ is temporarily tolling the minimum bid price rules for maintaining a listing until June 30, 2020 we cannot be assured that we will be able to maintain a $1 bid into the future. At this point I'm going to turn the call over to Brian for a review of our financials and other guidance items. Brian?