electroCore Announces Fourth Quarter and Full Year 2020 Financial Results
Full year 2020 net sales of approximately
Further reduced net cash usage to
Ended 2020 with cash and cash equivalents of
Company to host conference call and webcast today,
Fourth Quarter 2020 and Recent Highlights
|•||Reported full year 2020 net sales of approximately
|•||Used net cash of approximately
|•||Secured unique CMS Level II HCPCS reimbursement code for "Non-invasive vagus nerve stimulator";|
|•||Announced inclusion of gammaCore in new NHS England and NHS Improvement MedTech Funding Mandate Policy 2021/22, and two-year extension of gammaCore listing in the NHS Supply Chain Catalogue;|
|•||Executed distribution agreements with Pro Medica Baltic, RSK Medical and Medistar for distribution of gammaCore Sapphire in
|•||Obtained 510(k) clearance of gammaCore to expand its indication into preventative and acute treatment of adolescent migraine (ages 12-17);|
|•||Announced completion of enrollment in the investigator-initiated SAVIOR-1 clinical trial evaluating gammaCore Sapphire CV in hospitalized COVID-19 patients exhibiting respiratory symptoms;|
|•||Announced publication of a peer reviewed paper entitled: “Non-Invasive vagus nerve stimulation to reduce ileus after major colorectal surgery: Early development study” in the journal Colorectal Disease on use of nVNS to reduce post-operative ileus after major colorectal surgery;|
|•||Announced selection of gammaCore for NIDA-sponsored study in opioid use disorders;|
|•||Announced full enrollment in study of gammaCore for the acute treatment of stroke supported by the
|•||Presented positive topline results from the
Dan Goldberger, Chief Executive Officer of electroCore, commented: “We had a highly productive fourth quarter across all facets of our business in spite of the challenges and headwinds of the pandemic. We delivered 38% year-over-year revenue growth in the quarter, we achieved a major
“Notably, we were able to achieve all of this while continuing to manage our cash prudently. Our net cash usage for the fourth quarter of
“Looking ahead, while the course of the pandemic remains difficult to predict, I believe we have taken steps to ensure continued growth of gammaCore in our core revenue generating channels while working to establish and capitalize on new opportunities. I believe gammaCore has broad potential utility across a very diverse range of indications, and along with the entire electroCore team, I remain committed to making this therapy available to every individual who can potentially benefit from it.”
Fourth Quarter and Full Year 2020 Financial Results
For the quarter ended
Revenue from the
Revenue from outside
Gross profit for the fourth quarter of 2020 was
Total operating expenses in the fourth quarter of 2020 were approximately
Research and development expense in the fourth quarter of 2020 was
Selling, general and administrative expense in the fourth quarter of 2020 was
GAAP net loss in the fourth quarter of 2020 was
Adjusted EBITDA net loss in the fourth quarter of 2020 was a loss of
The company defines adjusted EBITDA net loss as GAAP net loss, excluding income tax expense/benefit, depreciation and amortization, stock-compensation expense, write-off of right of use operating lease, increase in inventory reserves, restructuring and other severance related charges, legal fees associated with stockholders’ litigation and total other income/expense. A reconciliation of GAAP net loss to Non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in this press release.
Net cash used in the quarter ended
Cash and cash equivalents and marketable securities at
Webcast and Conference Call Information
electroCore’s management team will host a conference call today,
Investors interested in listening to the conference call or webcast may do so by dialing 877-407-4018 for domestic callers or 201-689-8471 for international callers, using conference ID: 13715729, or through the following link: http://public.viavid.com/index.php?id=143276
An archived webcast of the event will be available on the “Investors” section of the company’s website at: www.electrocore.com.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore is FDA cleared in
|•||gammaCore is contraindicated for patients with:|
|○||An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device|
|○||A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck|
|○||An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location|
|•||Safety and efficacy of gammaCore have not been evaluated in the following patients:|
|○||Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)|
|○||Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)|
|○||Pediatric patients (younger than 12 years)|
|○||Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia|
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
gammaCore Sapphire™ CV has received Emergency Use Authorization (EUA) from the FDA for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus Nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.
Please refer to gammaCore Sapphire CV (nVNS) Instructions for Use for Use for all of the important warnings and precautions before using or prescribing gammaCore Sapphire CV (nVNS).
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans, its expected cash runway, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including commercialization of, and potential reimbursement for, gammaCore Sapphire CV, the business, operating or financial impact of such studies, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the
Consolidated Statements of Operations
(In thousands, except per share data)
|Cost of goods sold||818.9||391.0||1,737.5||1,157.0|
|Research and development||1,018.7||1,623.0||4,201.3||9,902.2|
|Selling, general and administrative||5,413.8||7,267.0||21,840.9||35,422.3|
|Restructuring and other severance related charges||—||—||464.6||1,997.3|
|Total operating expenses||6,432.5||8,890.0||26,506.8||47,321.8|
|Loss from operations||(6,323.2||)||(8,606.0||)||(24,748.5||)||(46,088.5||)|
|Interest and other income||(3.8||)||(121.0||)||(84.3||)||(970.6||)|
|Total other expense/(income)||0.6||(125.3||)||(66.5||)||(958.3||)|
|Loss before income taxes||(6,323.8||)||(8,480.7||)||(24,682.0||)||(45,130.2||)|
|(Provision)/benefit for income taxes||—||(17.7||)||1,170.9||(17.7||)|
|Net loss per share of common stock - Basic and Diluted||(0.14||)||(0.29||)||(0.60||)||
|Weighted average number of shares common shares outstanding -
Basic and Diluted
Consolidated Balance Sheet Information
|Cash and cash equivalents||$||4,241.9||$||13,563.8|
(Unaudited) Use of Non-GAAP Financial Measure
The company is presenting adjusted EBITDA net loss because it believes this measure is a useful indicator of its operating performance. electroCore management uses this non-GAAP measure principally as a measure of the company’s core operating performance and believes that this measure is useful to investors because it is frequently used by the financial community, investors, and other interested parties to evaluate companies in the company’s industry. The company also believes that this measure is useful to its management and investors as a measure of comparative operating performance from period to period. Additionally, the company believes its use of non-GAAP adjusted EBITDA net loss from operations facilitates management’s internal comparisons to historical operating results by factoring out potential differences caused by charges not related to its regular, ongoing business, including, without limitation, non-cash charges and certain large and unpredictable charges such as restructuring expenses.
The company has presented adjusted EBITDA net loss as a non-GAAP financial measure in this press release. The company defines adjusted EBITDA net loss as its reported GAAP net loss excluding income tax expense/benefit, depreciation and amortization, stock-based compensation, write-off of right of use operating lease, increase in inventory reserves, restructuring and other severance related charges, legal fees associated with stockholders litigation and total other income/expense.
|Three months ended||Year ended|
|GAAP net loss||$||(6,323.8||)||$||(8,498.4||)||$||(23,511.1||)||$||(45,147.9||)|
|Provision/(benefit) for income taxes||—||17.7||$||(1,170.9||)||$||17.7|
|Depreciation and amortization||110.6||97.3||$||399.2||$||249.6|
|Write-off of right of use operating lease||557.5||—||557.5||—|
|Increase in inventory reserves||434.0||—||434.0||—|
|Restructuring and other severance related charges||—||—||$||464.6||$||1,997.3|
|Legal fees associated with stockholders’ litigation||135.5||$||641.0||$||1,205.3||$||963.0|
|Total other (income)/expense||0.6||$||(125.3||)||$||(66.5||)||$||(958.3||)|
|Adjusted EBITDA net loss||$||(4,309.9||)||$||(6,662.3||)||$||(18,421.6||)||$||(38,982.8||)|
|The company’s use of a non-GAAP measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of its results as reported under GAAP. Some of these limitations are: the non-GAAP measure does not reflect interest or tax payments that may represent a reduction in cash available; although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and the non-GAAP measure does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; the non-GAAP measure does not reflect the potentially dilutive impact of equity-based compensation; and the non-GAAP measure does not reflect changes in, or cash requirements for, working capital needs; other companies, including companies in electroCore’s industry, may calculate adjusted EBITDA net loss differently, which reduces its usefulness as a comparative measure.
Because of these and other limitations, you should consider the non-GAAP measure together with other GAAP-based financial performance measures, including various cash flow metrics, net loss, and other GAAP results. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the preceding financial statements table of this press release.