Dan Goldberger
Analyst · BTIG. Please proceed with your question
Thank you, Hans. Hello, everybody, and thank you for joining us today. We're pleased to report record revenue and ongoing reductions in operating expenses and cash burn for the quarter ended September 30, 2020. Brian will cover the financials in detail, but I wanted to begin with a few highlights. First, we generated total third quarter revenue of approximately $1.1 million, representing an increase of 44% sequentially and 58% over the third quarter of 2019. We're still in the very early stages of commercializing gammaCore non-invasive Vagus Nerve Stimulation therapy, or nVNS and we are pleased to see a renewed ability to grow revenue against a backdrop of COVID-19, demonstrating that we are adapting successfully to the new normal. During the third quarter, we saw a resumption of growth in all three of our primary revenue channels, the Department of Veterans Affairs, commercial prescriptions in the United States and in the United Kingdom. Notably, we were able to achieve these results while continuing to manage our spending and balance sheet aggressively. During the third quarter, we used $4.1 million in cash to fund our operations. We ended the third quarter with cash and cash equivalents of approximately $26 million, which we believe provides substantial runway and resources to support a number of important and potentially value creating milestones. Turning now to an operational update, beginning with our COVID-19 initiatives. Recall that in July, 2020, we announced an FDA emergency use authorization or UA for the use of gammaCore Sapphire™ CV at home or in a healthcare setting for the acute treatment of adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduce airflow and for whom approved drug therapies are not tolerated or provide insufficient symptom relief. Reactive airway disease was among the first areas of research for the company and prior prospective studies on the use of nVNS to treat asthma symptoms, provide strong rationale for this therapy as a COVID treatment. Upon receiving the EUA, we moved quickly to establish multiple access channels for patients to procure the device for $1,250, a substantial discount from the $1,750 list price. It is available by prescription throughout our VA, DoD channels to hospitals directly from the company and through our specialty pharmacy partner, Premier Specialty Pharmacy by obtaining a prescription through a patient's health care provider or through a telehealth consult powered by our telehealth partner Upscript, LLC. With Upscript’s comprehensive online telehealth platform, a patient can consult with a licensed healthcare provider in real-time and if the therapy is deemed appropriate, have a gammaCore Sapphire CV prescribed and shipped directly to his or her home. We have set up an online portal for patients to use www.getgammacore.com. We've taken a number of steps to generate awareness of gammaCore Sapphire CV for known or suspected COVID patients, but we're still in the early stages of product launch and relatively few prescriptions have been written and filled. That said it is worth noting the media coverage around our EUA has generated an increased interest in gammaCore for headache as well. We've previously announced that two investigator-initiated clinical studies were enrolling patients to evaluate nVNS therapy in hospitalized COVID patients, one in Valencia, Spain, and the other in Pittsburgh, Pennsylvania. The studies known as SAVIOR 1 and SAVIOR 2 respectively will measure the safety and efficacy of gammaCore Sapphire CV plus standard of care versus standard of care alone in patients hospitalized with COVID-19 across a broad range of clinical and laboratory endpoints. Enrollment in the SAVIOR studies has been slower than anticipated, however, with the increased cases around the world, enrollment trends have recently accelerated. At this point, I'd like to provide an update on key operating metrics and our individual revenue channel. During the third quarter 2,881 total paid months of therapy were utilized across our three revenue generating channels versus 2,407 in the second quarter. 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 third quarter 68 VA and DOD treatment facilities purchased gammaCore, compared to 67 during the second quarter of 2020 and 48 during the third quarter of 2019 Also, during the third quarter of 2020, the company shipped 1,571 paid months of therapy pursuant to VA and DOD originating prescriptions, compared to 988 paid months of therapy in the second quarter of 2020 and 553 during the third quarter of 2019. The 59% sequential increase in paid months of therapy in Q3 is a testament to our team's ability to be nimble and to adapt to a challenging environment that continues to evolve. Revenue from the VA and DOD in the third quarter was $646,000 as compared to $415,000 for the second quarter and $279,000 in the third quarter of 2019. Also related to the VA, in September 2020, we announced that the agency has agreed to sponsor a randomized, control clinical trial or RCT of nVNS in mild traumatic brain injury or mTBI and post-traumatic stress disorder or PTSD. The trial is being sponsored by the Department of Veterans Affairs, Office of Research and Development at the Atlanta VA Medical Center, and will be led by Dr. Douglas Bremner, staff physician at the Atlanta Veterans Clinic General Mental Health Unit at the Atlanta VA Medical Center, and Professor of Psychiatry and Behavioral Sciences and Radiology at the Emory University School of Medicine. Study, which is expected to enroll up to 100 veterans is designed to assess the clinical and physiological effects of nVNS in patients with mTBI and PTSD. Study’s primary outcome measures include assessments of the veterans’ clinical improvement, several objectives measurements of brain activity, and changes in the levels of the inflammatory cytokine interleukin-6 in response to stress. mTBI and PTSD are significant concerns in the VA, particularly among veterans with both conditions. As we indicated in our September 30 press release announcing the study, it's estimated that up to 56% of mTBI patients have comorbid PTSD and 18% of veterans have conflicts in Iraq and Afghanistan present with comorbid mTBI PTSD, making the comorbid condition more common than either disorder alone. There already exists a body of evidence that provides a strong mechanistic and clinical rationale for nVNS as a potential treatment for mTBI and PTSD. Earlier in the quarter, we announced the publication of a paper entitled non-invasive vagal nerve stimulation decreases brain activity during trauma scripts in the journal, Brain Stimulation. Dr. Bremner is a co-author of that paper, which reports on a double-blind, randomized control trial of 19 participants who had experienced trauma, but did not have the diagnosis of PTSD and highlights the ability of nVNS to decrease the fear associated with emotional stress. We are eager to see the results of this study, and we are hopeful that we can make a positive change in the lives of our veterans. To further support our VA and DoD initiatives, we announced the hiring of Commander Sylvester Steele for the newly created role of Vice President and General Manager of our Government Channels Business Unit. As the title implies this role is responsible for driving continued growth of nVNS therapy within the VA and DoD, as well as developing new revenue opportunities within government channels. Commander Steele brings a wealth of experience, creating and leading complex systems and organizations. His background includes more than 20 years in the United States Navy, where he served with distinction in a variety of leadership roles, including his Commanding Officer or Chief Executive Officer of two warships, USS Stout and USS The Sullivans, and as a senior advisor and strategic leader at U.S. Fleet Forces Command and Naval Special Warfare Development Group. Needless to say, Commander Steele has a perfect skill set for role. And we look forward to his contributions. Turning now to the United Kingdom and other OUS territories. During the third quarter of 2020, electric core shift approximately 1,020 paid months of therapy outside of the United States as compared to 938 paid months of therapy during the second quarter of 2020 and 828 during the third quarter of 2019. Revenue generated outside the U.S. was $278,000 in the third quarter as compared to $247,000 in the second quarter of 2020, and $188,000 in the third quarter of 2019. New patient starts to continue to be impacted by the COVID pandemic, but we're optimistic that we can sustain growth in both revenue and paid months of therapy in the fourth quarter and entering 2021. Last month, we announced that gammaCore would continue to be reimbursed in England under the NHS Innovation and Technology Payment Program, or ITPP for the treatment of cluster headache in adults for an additional six months through March, 2021. The proposed contract includes the option to extend for up to an additional three years through March 31, 2024. The potential contract value is a three-year extension option is exercised, could be up to approximately 3.6 million pounds or approximately $4.7 million based on the current exchange rate. Since reimbursement commenced under this program in April, 2019, we've built a steady base of users and this extension ensures their continued access to therapy, potentially for an additional three and a half years, more than 55,000 adults in England suffer from cluster headache, a truly debilitating condition with few effective treatment options. Turning to our commercial prescriptions, we previously announced that we've successfully restructured our distribution channel by eliminating layers and selling through the inventory that had been placed with distributors during 2019. We recognized a small amount of revenue from specialty pharmacy replenishment in June 2020. And we recognized a full three months of replenishment revenue in the quarter ended September 30, 2020. Commercial replenishment revenue of $112,000 in Q3 was a significant contributor to our strong performance in the quarter. Now that we've cleaned up the channel. The company can once again make investments to grow the commercial prescription business. We started to call on commercial insurers that work through our existing contracts with the pharmacy benefit managers like CVS and express scripts, with the goal of adding nVNS to benefit plans with more covered lives. In parallel, we are working towards providing a pathway through the medical benefit, including our pending application for a unique HCPCS code. We should have additional information about the CMS process early next year. Moving now out to a clinical update, we previously announced that the premium to trial and migraine prevention was closed early due to the pandemic in March 2020. At that time, we had 231 patients in the intent-to-treat group and 113 patients in the modified intent-to-treat group. This compares to the original enrollment targets of approximately 400 patients in the intent-to-treat group for a population of approximately 300 in the modified intent-to-treat group. We continue to analyze data from the study and are working to present top-line findings before the end of the year. Company is providing devices and support for several other investigator initiated trials in a variety of indications. Many of these are having difficulty recruiting patients in the short term, as the world manages through the pandemic. The studies allowed for the development of novel data and possible additional indications for nVNS, without a significant outlay of our financial resources. We will share updates on these programs as they become available. At this point, I'll turn the call over to Brian for review of our financials and other guidance items.