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electroCore(ECOR) - 2021 Q3 - Earnings Call Transcript
2021-11-07 04:58
electroCore, Inc. (NASDAQ:ECOR) Q3 2021 Earnings Conference Call November 4, 2021 4:30 PM ET Company Participants Rich Cockrell - CG Capital Daniel Goldberger - CEO & Director Peter Staats - Chief Medical Officer Brian Posner - CFO & Corporate Secretary Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann & Co. Swayampakula Ramakanth - H.C. Wainwright & Co. John Vandermosten - Zacks Investment Research Operator Greetings, and welcome to electroCore's Third Quarter 2021 Earnings Call. [Operator In ...
electroCore(ECOR) - 2021 Q3 - Quarterly Report
2021-11-03 16:00
PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Financial%20Statements) Q3 2021 unaudited financials show significant cash and equity growth from financing, with sales up and net loss narrowed [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2021, total assets and equity significantly increased due to cash growth, while liabilities decreased Condensed Consolidated Balance Sheet Data (in thousands) | Balance Sheet Item | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,995 | $4,242 | | Total current assets | $41,885 | $25,064 | | **Total assets** | **$47,571** | **$31,518** | | **Liabilities & Equity** | | | | Total current liabilities | $5,739 | $5,890 | | **Total liabilities** | **$6,454** | **$7,874** | | **Total equity** | **$41,116** | **$23,645** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q3 and nine-month 2021 statements show strong net sales growth and significantly narrowed net losses year-over-year Statement of Operations Highlights (in thousands) | Metric | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $1,487 | $1,081 | $3,960 | $2,568 | | Gross profit | $1,132 | $733 | $2,867 | $1,649 | | Loss from operations | $(3,985) | $(4,489) | $(14,571) | $(18,425) | | Net loss | $(3,994) | $(4,486) | $(12,271) | $(17,187) | | Net loss per share | $(0.06) | $(0.10) | $(0.22) | $(0.47) | [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Comprehensive loss improved in Q3 and nine-month 2021 periods, driven by a smaller net loss and positive FX adjustments Comprehensive Loss Summary (in thousands) | Metric | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(3,994) | $(4,486) | $(12,271) | $(17,187) | | Other comprehensive (loss) income | $(22) | $(84) | $127 | $(149) | | **Comprehensive loss** | **$(4,016)** | **$(4,570)** | **$(12,145)** | **$(17,336)** | [Condensed Consolidated Statements of Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Equity) Total equity substantially increased to $41.1 million, primarily from common stock issuance, offsetting the net loss - Total equity grew from **$23.6M** on Jan 1, 2021, to **$41.1M** on Sep 30, 2021, mainly due to capital raised from issuing new stock, which counteracted the period's net loss[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Improved operating cash flow and significant financing from stock issuances led to a substantial increase in cash reserves Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,274) | $(16,470) | | Net cash provided by (used in) investing activities | $17,217 | $(11,666) | | Net cash provided by financing activities | $25,685 | $18,550 | | **Net increase (decrease) in cash** | **$33,753** | **$(9,731)** | | **Cash and cash equivalents – end of period** | **$37,995** | **$3,832** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, liquidity risks, revenue concentration, PPP loan forgiveness, stock offerings, and ongoing litigation [Note 3. Significant Risks and Uncertainties](index=11&type=section&id=Note%203.%20Significant%20Risks%20and%20Uncertainties) Going concern doubt is mitigated by recent financing, providing 12-month capital, despite high revenue concentration with key clients - The company acknowledges substantial doubt about its ability to continue as a going concern due to historical net losses, but believes this is alleviated by recent capital raises, providing a cash runway for at least the next 12 months[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) Revenue Concentration by Channel | Revenue Channel | Q3 2021 | Nine Months 2021 | | :--- | :--- | :--- | | Dept. of Veterans Affairs & DoD | 63.6% | 60.7% | | National Health Service (UK) | 24.1% | 25.6% | [Note 4. Revenue Recognition](index=12&type=section&id=Note%204.%20Revenue%20Recognition) Revenue from gammaCore sales is recognized upon delivery, with the US and UK as primary growing markets Net Sales by Geographic Area (in thousands) | Geographic Market | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | United States | $1,104 | $801 | $2,810 | $1,759 | | United Kingdom | $367 | $278 | $1,038 | $801 | | Other | $17 | $2 | $112 | $7 | | **Total Net Sales** | **$1,487** | **$1,081** | **$3,960** | **$2,568** | [Note 10. Notes Payable & Note 11. Stockholders' Equity](index=16&type=section&id=Note%2010.%20Notes%20Payable%20%26%20Note%2011.%20Stockholders'%20Equity) PPP loan was forgiven, and significant capital was raised from a public offering and prior equity agreement termination - The company's **$1.4 million** Paycheck Protection Program (PPP) loan was fully forgiven by the SBA in May 2021[71](index=71&type=chunk)[72](index=72&type=chunk) - A public offering in July 2021 raised net proceeds of approximately **$18.8 million** from the sale of **20.7 million** shares of common stock[72](index=72&type=chunk) - The equity facility with Lincoln Park was terminated in March 2021 after the company sold an additional **2.75 million** shares for **$6.9 million** in January 2021[76](index=76&type=chunk) [Note 15. Commitments and Contingencies](index=20&type=section&id=Note%2015.%20Commitments%20and%20Contingencies) Company faces multiple stockholder lawsuits related to its IPO and disclosures, with potential losses currently unestimable - The company is involved in multiple stockholder lawsuits, including class actions and derivative actions, stemming from its IPO and post-IPO disclosures[92](index=92&type=chunk)[94](index=94&type=chunk)[97](index=97&type=chunk) - Due to the preliminary stage of the litigation, the company cannot determine the reasonable probability of loss or a range of potential loss and has not established an accrual[98](index=98&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=22&type=section&id=Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A highlights strong revenue growth, narrowed net loss, and sufficient liquidity for 12 months despite going concern doubts [Overview](index=22&type=section&id=Overview) electroCore focuses on its FDA-cleared gammaCore nVNS therapy, targeting US VA/DoD and UK markets, and expanding globally - The company's core business is its proprietary nVNS therapy, **gammaCore**, which is FDA-cleared for multiple headache indications[103](index=103&type=chunk) - The primary commercial focus is on two channels: the U.S. Department of Veterans Affairs/DoD and the United Kingdom's National Health Service[106](index=106&type=chunk) - The company is expanding its global presence through agreements with new international distributors[108](index=108&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q3 and nine-month 2021 results show significant sales growth, improved gross margin, and narrowed net losses, aided by PPP loan forgiveness Q3 2021 vs. Q3 2020 Results (in thousands) | Metric | Q3 2021 | Q3 2020 | Change | | :--- | :--- | :--- | :--- | | Net sales | $1,487.1 | $1,080.9 | $406.2 | | Gross profit | $1,132.1 | $733.4 | $398.7 | | Loss from operations | $(3,985.0) | $(4,488.6) | $503.6 | | Net loss | $(3,993.7) | $(4,486.4) | $492.7 | Nine Months 2021 vs. 2020 Results (in thousands) | Metric | Nine Months 2021 | Nine Months 2020 | Change | | :--- | :--- | :--- | :--- | | Net sales | $3,960.4 | $2,567.6 | $1,392.8 | | Gross profit | $2,867.1 | $1,649.0 | $1,218.1 | | Loss from operations | $(14,571.3) | $(18,425.3) | $3,854.0 | | Net loss | $(12,271.3) | $(17,187.3) | $4,916.0 | - The nine-month net loss improvement was supported by a **$1.4 million** gain on the extinguishment of the PPP loan[128](index=128&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) Company holds $39.0 million in cash, asserting sufficient liquidity for 12 months despite recurring losses and going concern doubts - The company had **$39.0 million** in cash, cash equivalents, and marketable securities as of September 30, 2021[134](index=134&type=chunk) - Net cash used in operating activities for the first nine months of 2021 was **$9.3 million**, a significant improvement from **$16.5 million** in the same period of 2020[130](index=130&type=chunk) - Management believes that despite a history of losses, cash on hand is sufficient to fund operating expenses and capital requirements for at least the next 12 months[138](index=138&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks are foreign currency and interest rate fluctuations, with no current hedging instruments - The company's main market risks include foreign currency fluctuations, particularly from sales in British Pound Sterling, and interest rate changes affecting its cash and marketable securities[140](index=140&type=chunk) [Controls and Procedures](index=28&type=section&id=Controls%20and%20Procedures) Management concluded disclosure controls were effective as of September 30, 2021, with no material changes to internal controls - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[142](index=142&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[143](index=143&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) Company faces multiple stockholder lawsuits related to its IPO, with potential losses currently unestimable - The company is defending against multiple stockholder lawsuits (class action and derivative) in both state and federal courts concerning its IPO and subsequent disclosures[145](index=145&type=chunk)[146](index=146&type=chunk)[150](index=150&type=chunk) - A state court dismissal was reversed on appeal, and a federal case was dismissed with leave to re-plead. The company cannot determine the probability or range of potential loss at this stage[145](index=145&type=chunk)[147](index=147&type=chunk)[153](index=153&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors focus on COVID-19 impacts, including operational disruptions, revenue loss, and vaccine mandate challenges - The COVID-19 pandemic continues to pose significant risks to the business, including potential impacts on manufacturing, sales efforts, and overall financial condition[156](index=156&type=chunk)[157](index=157&type=chunk) - A federal vaccine mandate for contractors could lead to the loss of the company's Federal Supply Schedule contract, and the company's internal mandatory vaccination policy may adversely affect employee recruitment and retention[157](index=157&type=chunk) - The broad availability of COVID-19 vaccines may reduce demand for **gammaCore Sapphire CV**, which is authorized for use under an Emergency Use Authorization (EUA)[163](index=163&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=32&type=section&id=Other%20Items%20(Items%202,%203,%204,%205,%206)) Other disclosures include no unregistered equity sales, no senior security defaults, and a list of filed exhibits - The company reported no unregistered sales of equity securities or defaults upon senior securities during the reporting period[165](index=165&type=chunk)[166](index=166&type=chunk) - The report includes standard exhibits, such as officer certifications required by the Sarbanes-Oxley Act and interactive data files (XBRL)[172](index=172&type=chunk)
electroCore(ECOR) - 2021 Q2 - Earnings Call Transcript
2021-08-08 15:28
electroCore, Inc. (NASDAQ:ECOR) Q2 2021 Earnings Conference Ca August 5, 2021 4:30 PM ET Company Participants Rich Cockrell - CG Capital Dan Goldberger - Chief Executive Officer Brian Posner - Chief Financial Officer Peter Staats - Chief Medical Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann John Vandermosten - Zacks SCR Operator Greetings, and welcome to the electroCore Second Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A questio ...
electroCore(ECOR) - 2021 Q2 - Quarterly Report
2021-08-04 16:00
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 June 30, 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) (State or other juris ...
electroCore(ECOR) - 2021 Q1 - Earnings Call Transcript
2021-05-10 07:19
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 ...
electroCore(ECOR) - 2021 Q1 - Quarterly Report
2021-05-05 16:00
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(ECOR) - 2020 Q4 - Earnings Call Transcript
2021-03-12 03:11
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 ...
electroCore(ECOR) - 2020 Q4 - Annual Report
2021-03-10 16:00
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]
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 ...