electroCore, Inc. (NASDAQ:ECOR) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET Company Participants Rich Cockrell - CG Capital Dan Goldberger - Chief Executive Officer Peter Staats - Chief Medical Officer Brian Posner - Chief Financial Officer Conference Call Participants Carolyn Huszagh - BTIG Sean Kang - H.C. Wainwright Jeremy Pearlman - Maxim Group John Vandermosten - Zacks Operator Greetings and welcome to the electroCore's First Quarter 2021 Earnings Conference Call. [Operator Instructions] As ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 1 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ______________ Commission File Number 001-38538 electroCore, Inc. (Exact name of Registrant as specified in its charter) Delaware 20-3454976 ...

electroCore, Inc. (NASDAQ:ECOR) Q4 2020 Earnings Conference Call March 11, 2021 4:30 PM ET Company Participants Hans Vitzthum - LifeSci Advisors Dan Goldberger - CEO Peter Staats - CMO Brian Posner - CFO Conference Call Participants Ryan Zimmerman - BTIG Daniel Stauder - JMP Securities Sean Kang - H.C. Wainwright Anthony Vendetti, - Maxim Group John Vandermosten - Zacks SCR Operator Greetings, ladies and gentlemen and welcome to the electroCore's Fourth Quarter 2020 Earnings Conference Call. Currently at th ...

Product Approval and Regulatory Compliance - gammaCore therapy is FDA-cleared for the acute treatment of pain associated with migraine and episodic cluster headache, with an estimated 39 million patients in the U.S. suffering from migraine[22] - The FDA granted an Emergency Use Authorization for gammaCore Sapphire CV to treat adult patients with known or suspected COVID-19 experiencing asthma-related dyspnea[19] - The unique HCPCS code K1020 for "non-invasive vagus nerve stimulator" was established to streamline reimbursement for gammaCore therapy, effective April 1, 2021[25] - gammaCore has received CE Mark approval for multiple indications in the European Economic Area, enhancing its commercial potential[26] - The National Institute for Health and Care Excellence (NICE) recommended gammaCore for use in the NHS, which supports its reimbursement pathway in the UK[27] - The FDA cleared gammaCore for the acute treatment of migraine in adults, showing a pain freedom rate of 30.4% at 120 minutes in pivotal trials[58] - The FDA approved gammaCore for the prevention of cluster headaches, with a significant reduction in the number of attacks per week (-5.9 vs. -2.1; p<0.001) in pivotal trials[74] - The FDA has cleared gammaCore for the acute and preventive treatment of migraine in adolescents aged 12 to 17, based on previous studies[58] - The company received CE Certificate of Conformity for gammaCore therapy, which includes treatment for primary headaches and additional indications for reactive airway disease[142] - gammaCore is classified as a Class IIa medical device in the EU, requiring compliance with essential requirements and a conformity assessment procedure[145] - The EU Medical Devices Regulation (MDR) adopted in May 2017 aims to establish a uniform regulatory framework across the EEA, applicable from May 26, 2021[146] - The company has the necessary certificates for compliance with the MDR[147] - The PMA process for Class III devices requires extensive data, including preclinical studies and human clinical trials[122] - The FDA may require post-market surveillance for devices to ensure ongoing safety and effectiveness[124] - Modifications affecting safety or effectiveness of a PMA-approved device require new PMA approval or PMA supplements[125] - The FDA may issue an Emergency Use Authorization (EUA) for unapproved products during declared emergencies[127] Financial Performance and Economic Impact - The indirect annual costs associated with migraine in the U.S. are estimated at $19.3 billion[22] - The annual economic burden of migraine in the United States is approximately $78 billion, with direct and indirect costs for chronic migraine patients estimated between $8,500 and $9,500[59] - The overall average medical costs for eCH patients over a three-year period exceeded $22,500, compared to $10,140 for non-headache sufferers[76] - The total addressable market for the treatment of CH in the United Kingdom in 2021 is estimated to be approximately £100 million[79] - The overall cost for treating CH patients in England over the next five years is projected to be approximately £218.7 million[80] - The average monthly cost of Imitrex for CH patients and their insurance providers exceeds $700, limiting patient access to only six to ten doses per month[77] - The company incurred net losses of $23.5 million and $45.1 million for the years ended December 31, 2020, and 2019, respectively, with an accumulated deficit of $107.0 million as of December 31, 2020[186] - The company has never been profitable and expects to continue incurring substantial net losses and negative cash flows from operations as it commercializes gammaCore therapy[188] Market Strategy and Distribution - The company entered into exclusive distribution agreements for gammaCore therapy in Eastern Europe, Canada, and Australia, expanding its international reach[46] - The company is exploring additional indications for nVNS technology, including potential applications for COVID-19 symptoms and PTSD, supported by various clinical studies[51] - The company is evaluating further international distribution opportunities for nVNS technology, anticipating future agreements[46] - The company plans to continue targeted investments in building its U.S. and UK commercial infrastructure to support gammaCore therapy[187] - The company plans to potentially expand its direct-to-consumer cash-pay business channel, which may require significant investment in sales and marketing capabilities[202] Intellectual Property and Competitive Position - The company has broad intellectual property protection, with key patents extending until 2033 for various aspects of its technology[39] - The company holds more than 170 patents and patent applications, with all current issued patents projected to expire between 2026 and 2033[105] - The company actively seeks to protect its intellectual property, including patents and trademarks, to maintain its competitive position[108] Risks and Uncertainties - The company faces significant risks and uncertainties regarding its ability to achieve adequate payer coverage and market acceptance for gammaCore therapy[203] - The completion of competitors' clinical trials could negatively impact the perception of the company's gammaCore therapy[88] - The coronavirus pandemic has severely depressed global economic activity, impacting the company's business operations and revenues[175] - The degree of impact from the coronavirus on the company's results remains uncertain and depends on various unpredictable future developments[179] - The pandemic may exacerbate other risks, potentially leading to a material adverse effect on the company[182] - The company is unable to reasonably estimate the pandemic's impact on its business and financial condition[181] - The company anticipates future healthcare reform measures that could limit federal and state government payments for healthcare products and services, potentially reducing demand[166] - Regulatory compliance failures can lead to enforcement actions, including fines, product recalls, and reputational damage[140] - The company faces risks of reduced market value for gammaCore therapy due to potential changes in payer plans and possible discontinuation of coverage by some payers[207] - Third-party payers have resisted covering gammaCore through pharmacy benefit plans, hindering the commercialization strategy and delaying revenue generation[212] - The need to modify the commercialization strategy due to lack of pharmacy benefit coverage may adversely affect sales and financial condition[213] Employment and Organizational Structure - The company employed 45 full-time employees as of March 1, 2021, with no employees represented by a labor union[169] Regulatory Environment - The company is subject to healthcare fraud and abuse regulations, including the federal Anti-Kickback Statute and the Physician Self-Referral Law[149][153] - Violations of the Anti-Kickback Statute can result in significant civil monetary penalties, criminal fines, and exclusion from federal healthcare programs[151] - The federal civil False Claims Act prohibits presenting false claims for federal funds, with penalties including treble damages and exclusion from federal healthcare programs[154] - The implementation of the Affordable Care Act has significantly changed healthcare financing and delivery, impacting medical device manufacturers[164] - The Budget Control Act of 2011 resulted in aggregate reductions to Medicare payments to providers, averaging 2% per fiscal year, effective from April 1, 2013, through 2029[165] - The company must comply with post-market surveillance regulations to ensure ongoing safety and effectiveness of its devices[140]

Financial Data and Key Metrics Changes - The company reported total revenue of approximately $1.1 million for Q3 2020, representing a sequential increase of 44% and a year-over-year increase of 58% [7][33] - GAAP net loss for Q3 2020 was $4.5 million, compared to a GAAP net loss of $10.7 million in Q3 2019 [37] - Adjusted EBITDA net loss for Q3 2020 was $3.3 million, compared to an adjusted EBITDA net loss of $8.7 million for the same period in 2019 [37] - Cash and cash equivalents at the end of Q3 2020 totaled approximately $26 million, an increase from approximately $24.1 million at the end of 2019 [38] Business Line Data and Key Metrics Changes - Revenue from the Department of Veterans Affairs (VA) and Department of Defense (DoD) was $646,000 in Q3 2020, up from $415,000 in Q2 2020 [17][34] - Paid months of therapy shipped to the VA and DoD increased by 59% sequentially to 1,571 in Q3 2020 from 988 in Q2 2020 [34] - Revenue generated outside the U.S. was $278,000 in Q3 2020, compared to $247,000 in Q2 2020 [24][34] - Commercial channel revenue was $112,000 for Q3 2020, up from $60,000 in Q2 2020 [34] Market Data and Key Metrics Changes - The company shipped 1,020 paid months of therapy outside the U.S. in Q3 2020, an increase from 938 in Q2 2020 [24] - The Federal Supply Schedule (FSS) remains the most important revenue channel, with 68 VA and DoD treatment facilities purchasing gammaCore in Q3 2020 [15][16] Company Strategy and Development Direction - The company is focused on commercializing gammaCore non-invasive Vagus Nerve Stimulation therapy and has seen growth in all three primary revenue channels despite COVID-19 challenges [8] - The company is optimistic about sustaining growth in revenue and paid months of therapy in Q4 2020 and into 2021 [25] - The company announced the hiring of Commander Sylvester Steele to drive growth within the VA and DoD channels [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed caution regarding Q4 2020 guidance due to potential COVID-related headwinds and seasonality [46][47] - The company is optimistic about returning to pre-pandemic growth rates in the VA channel and expects to see continued growth in the UK [59][60] - Management highlighted the importance of upcoming data events and the healthy cash balance to support future milestones [42] Other Important Information - The company received FDA emergency use authorization for gammaCore Sapphire CV for COVID-19 patients [10] - The company is working towards obtaining a unique HCPCS code to facilitate reimbursement processes [29][70] Q&A Session Summary Question: What is the guidance for Q4 revenue? - Management indicated that the guidance is conservative due to COVID ramping up and potential impacts on VA facilities [46][47] Question: What is needed to get covered lives in the commercial channel? - Management noted that normalcy is needed for payers to take meetings, and they are optimistic about the data from the UK [48][49] Question: What are the trends in the VA system regarding telehealth and in-person visits? - Management observed a return to in-person consults over the summer, but noted a reversal as COVID cases increased [68][69] Question: What is the status of the pending application for a unique CMS code? - Management stated that the timeline is uncertain due to COVID-related delays, but it is crucial for negotiating reimbursement [70][71] Question: What are the plans for the VA study on traumatic brain injury and PTSD? - Management is optimistic about showing efficacy and plans to extend labeling into these indications if results are positive [73]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share ECOR The Nasdaq Global Select Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ...

electroCore, Inc. (NASDAQ:ECOR) Q2 2020 Earnings Conference Call August 13, 2020 4:30 PM ET Company Participants Hans Vitzthum - LifeSci Advisors Dan Goldberger - Chief Executive Officer Brian Posner - Chief Financial Officer Conference Call Participants Ryan Zimmerman - BTIG Swayampakula Ramakanth - H.C. Wainwright John Vandermosten - Zacks Investment Research Operator Greetings and welcome to electroCore's Second Quarter 2020 Earnings Conference Call. At this time all participants are in a listen-only mod ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ______________ Commission File Number 001-38538 electroCore, Inc. (Exact name of Registrant as specified in its charter) Delaware 20-3454976 (St ...

Financial Performance - Net sales for Q1 2020 were $733,771, a 79% increase compared to $409,601 in Q1 2019[16] - Gross profit for Q1 2020 was $435,656, compared to $251,810 in Q1 2019, reflecting improved operational efficiency[16] - The net loss for Q1 2020 was $7,959,349, compared to a net loss of $13,861,530 in Q1 2019, indicating a 43% improvement[16] - The company reported a basic and diluted net loss per share of $0.27 for Q1 2020, an improvement from $0.47 in Q1 2019[16] - The company reported a net loss of $7.96 million for the three months ended March 31, 2020, compared to a net loss of $13.86 million for the same period in 2019, representing a 42% improvement in losses year-over-year[40] - Net loss from operations improved to $7,959.3 million for the three months ended March 31, 2020, compared to a net loss of $13,861.5 million in the prior year, reflecting a reduction of $5,902.2 million[139] Cash and Liquidity - Cash and cash equivalents increased to $15,620,496 as of March 31, 2020, from $13,563,791 at December 31, 2019[11] - The company had cash and cash equivalents of $15.62 million as of March 31, 2020, compared to $6.95 million at the end of the same period in 2019, indicating improved liquidity[27] - The company generated net cash used in operating activities of $8.38 million for the three months ended March 31, 2020, an improvement from $16.40 million for the same period in 2019[27] - The company entered into an equity facility purchase agreement with Lincoln Park Capital Fund, allowing it to sell up to $25 million in common stock, which is expected to provide additional funding[41] - The company received approximately $5 million in aggregate proceeds from sales of common stock to Lincoln Park and a private placement transaction in April 2020[42] - The company entered into a loan for approximately $1.4 million under the Paycheck Protection Program (PPP) as part of the CARES Act[43] Operating Expenses - Total operating expenses decreased to $8,448,840 in Q1 2020 from $14,462,822 in Q1 2019, a reduction of approximately 41%[16] - Selling, general and administrative expenses fell by $4.4 million or 40% to $6,560.7 million for the three months ended March 31, 2020, primarily due to reductions in personnel and non-personnel costs[130] - Research and development expenses decreased by $1.9 million or 56% to $1,523.1 million for the three months ended March 31, 2020, due to significant reductions in near-term investment[129] Assets and Liabilities - Total assets decreased to $26,364,264 as of March 31, 2020, down from $35,461,679 at December 31, 2019[11] - Total liabilities reduced to $8,630,482 as of March 31, 2020, compared to $10,564,561 at December 31, 2019[11] - Current liabilities decreased to $7.35 million as of March 31, 2020, from $9.14 million at December 31, 2019, showing improved short-term financial health[11] Strategic Focus and Challenges - The company is focused on continuing its research and development efforts despite the challenges posed by the COVID-19 pandemic[8] - The company has focused on the commercialization and development of non-invasive Vagus Nerve Stimulation therapies for primary headache conditions[29] - The company has experienced significant net losses and expects to continue incurring losses as it works to increase market acceptance of its gammaCore therapy[39] - The company expressed substantial doubt about its ability to continue as a going concern within one year due to insufficient cash flow and liquidity[160] - Future operations depend on the ability to increase revenue, reduce operating expenses, and secure additional funding through equity or debt sales[160] Inventory and Expenses - Inventory as of March 31, 2020, totaled $890,992, with reserves for obsolete inventory amounting to $287,544[64] - Lease expenses for the three months ended March 31, 2020, were $119,650, a decrease from $199,654 in the same period of 2019[66] - The total future minimum lease payments as of March 31, 2020, amounted to $2,533,962, with $487,694 due in the remainder of 2020[68] Regulatory and Market Actions - The company submitted an Emergency Use Authorization application to the FDA for gammaCore therapy related to COVID-19 respiratory symptoms[115] - The company terminated its Premium II clinical trial in April 2020, resulting in no ongoing company-funded studies[116] - The company suspended its full-year revenue guidance on March 23, 2020, due to the impact of the COVID-19 pandemic[123]

Financial Data and Key Metrics Changes - Total revenue for Q1 2020 was $734,000, compared to $675,000 in Q4 2019, within the guidance range of $700,000 to $750,000 [20][41] - GAAP net loss from operations for Q1 2020 was $8 million, an improvement from a net loss of $13.9 million in Q1 2019 [46] - Adjusted EBITDA from operations for Q1 2020 was a loss of $6.4 million, compared to a loss of $13.4 million for the same period in 2019 [47] - Cash and cash equivalents at March 31, 2020, totaled approximately $15.6 million, down from approximately $24.1 million at December 31, 2019 [48] Business Line Data and Key Metrics Changes - Paid months of therapy increased by 20% sequentially to 2,633 in Q1 2020 from 2,195 in Q4 2019 [20] - Paid months of therapy shipped to the Veterans Administration (VA) and Department of Defense (DoD) increased by 31% sequentially to 1,084 in Q1 2020 from 829 in Q4 2019 [42] - Revenue from VA and DoD increased by 20% sequentially to $454,000 in Q1 2020 from $378,000 in Q4 2019 [24][42] - Paid months of therapy outside the U.S. increased to 1,008 from 961 in Q4 2019, but revenue from outside the U.S. decreased to $277,000 from $294,000 [31][43] Market Data and Key Metrics Changes - The company reported that more than 2,850 American physicians had written at least one gammaCore prescription by the end of Q1 2020, up from 2,735 at the end of Q4 2019 [19] - The National Institute for Health and Care Excellence in the UK recommended the use of gammaCore for treating cluster headaches, which is expected to enhance market penetration [29] Company Strategy and Development Direction - The company is focusing on leveraging its proprietary nVNS therapy to assist patients suffering from symptoms related to COVID-19, including submitting an emergency use authorization application to the FDA [12][70] - The company has redeployed sales resources to focus on the Federal Supply Schedule and the UK National Health Service, which are key revenue channels [21][30] - The company is exploring additional clinical trials to expand the indications for gammaCore therapy, including studies related to COVID-19 [37][72] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's performance despite the challenges posed by the COVID-19 pandemic, noting that the business has remained flat while many others have declined [67] - The management highlighted the potential for pent-up demand for gammaCore therapy as the migraine prevention label was approved, which could lead to increased sales once access to physicians improves [68] - The company anticipates revenue in excess of $700,000 for Q2 2020 and expects operating cash burn to be between $5 million and $6 million [52] Other Important Information - The company recorded a restructuring charge of $365,000 related to the transition to a new Chief Medical Officer [46] - The company raised $5 million through a stock purchase agreement and received $1.4 million from the Federal Paycheck Protection Program [49][50] - The company is asking shareholders for authority to implement a reverse stock split if necessary to preserve its NASDAQ listing [40] Q&A Session Summary Question: How are providers taking advantage of the migraine prevention indication? - Management noted that there is a cohort of prescribers who were waiting for the migraine prevention label, and they are starting to re-engage with these customers, although COVID-19 has limited immediate engagement [56] Question: What drove the increase in gross margins this quarter? - Management attributed the increase to aggressive expense reductions and higher volumes spreading fixed expenses over a larger revenue base, indicating that gross margins are expected to continue expanding [57][58] Question: How is the VA operating in terms of patient treatment? - Management indicated that VA facilities are making decisions based on local COVID-19 conditions, but some are beginning to schedule live meetings and see patients again, with telehealth being well-received [61][62] Question: What is the outlook for pent-up demand once operations normalize? - Management expressed optimism about returning to solid growth, noting that there is significant pent-up demand for gammaCore therapy due to the expanded indications [68] Question: What is the status of the EUA application for treating COVID-19 patients? - Management confirmed ongoing communication with the FDA regarding the EUA application but could not speculate on timing or approval [71]