electroCore Announces Second Quarter Financial Results
Received EUA and initiated gammaCore Sapphire CV distribution process for certain known or suspected COVID-19 patients experiencing asthma exacerbations
Generated sequential increase in revenue
Further strengthened balance sheet and reduced quarterly cash burn
Company to host conference call and webcast today,
Second Quarter 2020 and Recent Highlights
- Obtained Emergency Use Authorization (EUA) for the use of gammaCore Sapphire CV (non-invasive nerve stimulation or nVNS) in known or suspected COVID-19 patients who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief.
- Commenced support of two investigator-initiated clinical trials (IITs) of gammaCore Sapphire CV in COVID-19 patients in
Valencia, Spain(SAVIOR 1) and in Pittsburgh, PA(SAVIOR 2) which continue to enroll.
- Announced a publication in the journal Cephalalgia supporting the first line use of nVNS for the acute and preventative treatment of cluster headache and concluding that scientific and clinical studies support the emergence of non-invasive nerve stimulation as an effective, safe and practical treatment option for most primary headache disorders.
- Subsequent to the end of the second quarter, raised
$10.3 millionthrough the company’s existing stock purchase agreement with Lincoln Park Capitalannounced in March 2020, resulting in pro-forma June 30, 2020cash and cash equivalents and marketable securities of $29.2 million.
“Notwithstanding the impact of the pandemic on our core operations during the second quarter, we were nonetheless able to generate a sequential increase in revenue, driven largely by the replenishment order in the commercial channel, even while physicians, hospitals, and military treatment facilities pivoted to treat COVID patients. Total paid months of therapy were down only single digit percentages, a testament to the unwavering focus of the entire electroCore team who experienced unprecedented restrictions in their physician outreach efforts. We are encouraged that our two most significant revenue channels, the
“The redeployment and cost reduction plan that we announced in
Second Quarter 2020 Financial Results
For the quarter ended
Revenue from the
Revenue from outside the US decreased sequentially to
During the quarter ended
Total operating expenses for the second quarter of 2020 were approximately
SG&A expense declined approximately 44% to
Research and development expense decreased by approximately
During the second quarter of 2020, electroCore recorded a tax benefit of approximately
GAAP net loss for the second quarter of 2020 was
Adjusted EBITDA net loss for the second quarter of 2020 was a loss of
The company defines adjusted EBITDA net loss as GAAP net loss, excluding income tax expense/benefit, stock-compensation expense, 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 operations for 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
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 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
- 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
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients should not use gammaCore if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
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 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 for the above emergency use by FDA under an Emergency Use Authorization
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 all of the important warnings and precautions before using or prescribing gammaCore Sapphire CV (nVNA).
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 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, potential IITs for the study of gammaCore Sapphire CV in COVID-19 patients in
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
|For the three months
|For the six months
|Cost of goods sold||273.0||254.4||571.1||412.2|
|Research and development||1,030.5||2,510.4||2,553.6||5,970.3|
|Selling, general and administrative||5,273.3||9,387.9||11,834.1||20,390.9|
|Restructuring and other related charges||99.6||849.8||464.6||849.8|
|Total operating expenses||6,403.4||12,748.1||14,852.3||27,211.0|
|Loss from operations||(5,923.4||)||(12,379.8||)||(13,936.7||)||(26,590.9||)|
|Interest and other income, net||(11.7||)||(279.3||)||(74.7||)||(645.5||)|
|Total other (income)/expense||(11.0||)||(279.3||)||(64.9||)||(628.8||)|
|Loss before income taxes||(5,912.4||)||(12,100.5||)||(13,871.8||)||(25,962.1||)|
|Benefit from income taxes||1,170.9||—||1,170.9||—|
|Net loss per share of common stock - Basic and Diluted||(0.13||)||(0.41||)||(0.38||)||(0.89||)|
|Weighted average common shares outstanding - Basic and Diluted||36,658,797||29,341,574||33,216,512||29,330,442|
Condensed Consolidated Balance Sheet Information
|Cash and cash equivalents||$||14,863.1||$||13,563.8|
(Unaudited) Use of Non-GAAP Financial Measure
The company is presenting adjusted EBIDTA net loss because it believes this measure is a useful indicator of its operating performance. electroCore management uses this non-GAAP measure principally as a measure of the company’s core operating performance and believes that this measure is useful to investors because it is frequently used by the financial community, investors, and other interested parties to evaluate companies in the company’s industry. The company also believes that this measure is useful to its management and investors as a measure of comparative operating performance from period to period. Additionally, the company believes its use of non-GAAP adjusted EBITDA net loss from operations facilitates management’s internal comparisons to historical operating results by factoring out potential differences caused by charges not related to its regular, ongoing business, including, without limitation, non-cash charges and certain large and unpredictable charges such as restructuring expenses.
The company has presented adjusted EBITDA net loss as a non-GAAP financial measure in this press release. The company defines adjusted EBITDA net loss as its reported GAAP net loss excluding income tax expense/benefit, depreciation and amortization, stock-based compensation, restructuring and other severance related charges, legal fees associated with stockholders litigation and total other income /expense and other income and expense.
|For the three months
|For the six months
|GAAP net loss||$||(4,742||)||$||(12,101||)||$||(12,701||)||$||(25,962||)|
|Restructuring and other related charges||100||850||465||850|
|Legal fees associated with stockholders litigation||402||—||729||958|
|Total other (income)/expense||(11||)||(279||)||(65||)||(629||)|
|Benefit from income taxes||(1,171||)||—||(1,171||)||—|
|Adjusted EBIDTA net loss from operations||$||(4,322||)||$||(10,775||)||$||(10,801||)||$||(23,258||)|
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.