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electroCore(ECOR) - 2020 Q3 - Earnings Call Transcript
2020-11-13 03:23
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]
electroCore(ECOR) - 2020 Q3 - Quarterly Report
2020-11-12 22:03
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(ECOR) - 2020 Q2 - Earnings Call Transcript
2020-08-14 02:52
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 ...
electroCore(ECOR) - 2020 Q2 - Quarterly Report
2020-08-13 20:39
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 ...
electroCore(ECOR) - 2020 Q1 - Quarterly Report
2020-05-15 16:25
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]
electroCore(ECOR) - 2020 Q1 - Earnings Call Transcript
2020-05-15 02:51
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]
electroCore(ECOR) - 2019 Q4 - Annual Report
2020-03-30 20:47
Financial Performance - The company incurred net losses of $45.1 million and $55.8 million for the years ended December 31, 2019 and 2018, respectively, with an accumulated deficit of $83.5 million as of December 31, 2019[142]. - The company expects to continue incurring substantial net losses and negative cash flows from operations as it commercializes its gammaCore therapy[143]. - As of December 31, 2019, the company had cash and cash equivalents of $13.6 million and marketable securities of $10.5 million, indicating potential liquidity challenges[144]. - The company may need to seek additional funds in the future to support its commercialization efforts and research and development activities, which could impact its growth[146]. Market and Regulatory Challenges - The company relies heavily on third-party payers for adequate coverage and reimbursement for gammaCore therapy, which is essential for revenue generation[155]. - The lack of sufficient and timely coverage and reimbursement could adversely affect the demand for the company's products and its revenues[157]. - The company faces regulatory challenges as its products are not currently covered by Medicare and Medicaid, which could impact its commercialization strategy[159]. - The ongoing COVID-19 pandemic has significantly restricted economic activity, potentially affecting the company's business operations and revenues[161]. - The company has closed its New Jersey office and warehouse due to state-imposed restrictions related to the coronavirus outbreak, impacting its operational capabilities[164]. - Sales and marketing efforts with the VA and DoD are adversely affected by recent protocols for screening and restricting outside visitors and vendors[165]. - The company is unable to reasonably estimate the impact of the novel coronavirus outbreak on its business, revenues, financial condition, and results of operations, but the impact could be significantly negative[166]. Commercialization and Sales Strategy - The commercialization strategy may expose the company to increased billing, cash application, and credit risks due to the high cost of claims and complex billing requirements[168]. - Revenues from the sale of gammaCore therapy depend on the continued availability of reimbursement by government and private insurance plans, which involves a complex and time-consuming billing and collection process[169]. - The company faces challenges in obtaining coverage and reimbursement for gammaCore therapy under pharmacy benefit plans, which has hindered its commercialization strategy[171]. - The company must demonstrate the medical and economic benefits of gammaCore therapy compared to competitors' products to gain physician support and market acceptance[173]. - The company’s operating results may vary significantly from quarter to quarter due to factors such as physician and payer acceptance, timing of payer coverage, and seasonal variations in headache attacks[178]. Clinical Trials and Development - The company must overcome significant challenges in developing and commercializing its product candidates, including regulatory approval and market acceptance[176]. - Conducting clinical trials in the United States may incur significantly higher costs compared to foreign clinical trials, potentially impacting the company's financial condition[189]. - The company relies on patient enrollment for clinical trials; insufficient enrollment could delay research and development efforts, increasing costs and hindering product development timelines[190]. - Factors affecting patient enrollment include eligibility criteria, perceived risks and benefits, competition for patients, and the design of the trial[191]. - Delays in clinical trials could increase expenses and slow down the approval process for the gammaCore therapy, jeopardizing future revenue generation[195]. - The company has postponed certain clinical trials as part of a comprehensive redeployment plan and cost reduction strategy implemented in June 2019[197]. - The FDA or other regulatory bodies may suspend or terminate clinical trials due to various factors, including safety concerns and noncompliance with regulations[199]. Competition and Market Position - The company faces significant competition in the cluster headache (CH) and migraine markets, with established competitors having advantages such as larger sales forces and greater financial resources[215]. - The company has a limited commercial track record for its gammaCore therapy, which has been available for approximately two years in the United States, compared to traditional products that have been available for decades[219]. - Sales of gammaCore outside the United States represented a substantial portion of the company's net sales in 2019 and 2018, indicating reliance on international markets[221]. - The company must establish and strengthen its brand to achieve market acceptance of gammaCore therapy, which may require significant marketing expenses[229]. Intellectual Property and Legal Risks - The company may become involved in costly and time-consuming lawsuits to protect its intellectual property, which could hinder commercialization efforts[267]. - The success of the company depends on securing effective patent protection, which is expensive and time-consuming[268]. - The company may not be able to accurately estimate or control future operating expenses related to intellectual property, leading to potential cash shortfalls[273]. - The company may face challenges in obtaining necessary patents, which could allow competitors to market similar products without incurring significant development costs[269]. - Changes in patent laws and their interpretations may adversely affect the company's ability to protect its intellectual property rights[277]. - The company may face challenges to its patents, which could result in invalidation or limitations on their enforceability, impacting business objectives[280]. - Legal means provide limited protection for proprietary rights, and competitors may develop superior products not covered by existing patents[281]. Operational and Management Challenges - Future acquisitions may increase capital requirements and subject the company to risks such as increased operating expenses and dilution of stockholders[183]. - The company has reduced its direct salesforce, which may affect its ability to market and sell gammaCore therapy effectively in the United States[210]. - Future growth will require significant management resources to recruit, train, and integrate additional employees, which may strain the company's operational infrastructure[208]. - The company may encounter difficulties with manufacturing and supply chain issues, potentially leading to delays in the availability of gammaCore therapy and increased expenses[207]. - The company is dependent on retaining key executives and attracting new talent, with potential turnover risks due to unvested equity awards losing value[236]. - Effective succession planning is crucial for the company's long-term success, especially following the appointment of a new CEO in October 2019[239]. Compliance and Regulatory Environment - The company is subject to a wide variety of regulatory compliance requirements as a federal contractor, and failure to comply could adversely impact future contracts[251]. - The company faces risks related to government regulations that could delay the marketing of new products and impose costly procedures[324]. - The medical device industry is heavily regulated, with oversight from the FDA and other international regulatory agencies affecting all aspects of product development and marketing[330]. - The company must ensure adequate training for users and secure reimbursement for procedures performed with its products to support market acceptance[328].
electroCore(ECOR) - 2019 Q4 - Earnings Call Transcript
2020-03-24 03:20
electroCore, Inc. (NASDAQ:ECOR) Q4 2019 Earnings Conference Call March 23, 2020 4:45 PM ET Company Participants Hans Vitzthum - Investor Relations Dan Goldberger - Chief Executive Officer Brian Posner - Chief Financial Officer Conference Call Participants Ryan Zimmerman - BTIG Craig Bijou - Cantor Fitzgerald Swayampakula Ramakanth - H.C. Wainwright Ahu Demir - Noble Capital Operator Greetings. Welcome to electroCore’s Fourth Quarter and Full Year 2019 Earnings Conference Call. At this time all participants ...
electroCore(ECOR) - 2019 Q3 - Quarterly Report
2019-11-14 16:02
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 September 30, 2019 ☐ 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 20-345497 ...
electroCore(ECOR) - 2019 Q2 - Quarterly Report
2019-08-14 20:47
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, 2019 ☐ 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 ...