electroCore Provides Business Update and Select Financial Guidance
Full year 2020 revenue expected at the upper end of previously announced guidance range of
Net cash used for the fourth quarter 2020 of
“Notwithstanding the resurgence of COVID-19 case counts which began midway through the fourth quarter and impacted our customers and our ability to access them, we were able to deliver greater than 40% year-over-year revenue growth,” stated
COVID-19: The company previously announced that gammaCore Sapphire™ CV has been made available to known or suspected COVID-19 patients with asthma exacerbations under an FDA Emergency Use Authorization. The therapy is available by prescription through the
Government Channels: During the fourth quarter of 2020, 71
To facilitate growth of gammaCore within the
Outside of the
As noted previously, in
Commercial: The company continues to make measured investments in its Commercial channel, most notably through large insurers and pharmacy benefit managers, for the purpose of expanding the population of gammaCore covered lives.
To further support its commercial initiatives, the company continues to work toward establishing a unique HCPCS code that would streamline reimbursement for both government and commercial payers. The
Research and Development: As previously announced, gammaCore Sapphire CV is currently being evaluated in two investigator initiated trials (IITs) in hospitalized COVID-19 patients, one at Hospital Clínico Universitario de
In this population, 44.9% of the subjects using gammaCore nVNS had at least a 50% decrease in the number of migraine days compared to 26.8% for those receiving sham stimulation (secondary endpoint; p=0.048). Of particular clinical relevance were the results in the predefined sub-population of patients diagnosed as having migraine with aura. In this group, patients using nVNS had 5.5 fewer headache days compared to 2.7 fewer headache days in the sham group (p=0.041). Patients using gammaCore also reported a statistically significant decrease in migraine associated disability and improvement in their quality of life across all quality of life (QOL) endpoints in the study. There were no serious adverse effects reported in the study, which is consistent with nVNS’ strong safety and tolerability profile.
The company expects to publish full study results in a peer reviewed medical journal in 2021. gammaCore received 510(k) clearance for the preventative treatment of migraine on
This is in addition to the IIT assessing the utility of gammaCore in mild traumatic brain injury (mTBI) and Post-Traumatic Stress Disorder (PTSD) that electroCore announced during the third quarter. That study is also being conducted by
In addition to the programs discussed above, gammaCore investigator-initiated trials continue to progress in stroke, subarachnoid hemorrhage headache, and certain rheumatologic conditions.
electroCore today announced the following preliminary unaudited financial guidance for the fourth quarter of 2020:
Full-year 2020 Revenue: electroCore anticipates that full-year 2020 revenue will be at the upper end of the previously announced guidance range of
Q4 2020 net cash used: Net cash used during the fourth quarter of 2020 is expected to be approximately
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 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 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; or
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).
Please refer to the gammaCore™ Instructions for Use for all of the important warnings and precautions before using or prescribing this product available at www.gammacore.com.
The United States FDA has authorized use of the gammaCore Sapphire CV device 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 (VNS) on either side of the patient’s neck, available under an emergency access mechanism called an EUA.
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.
Further information is available at:
Authorization Letter: https://www.fda.gov/media/139967/download
Fact Sheet for Healthcare Providers: https://www.fda.gov/media/139968/download
Fact Sheet for Patients: https://www.fda.gov/media/139969/download
Instructions for gammaCore use https://www.fda.gov/media/139970/download
This press release 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 expectations for revenue and cash used in operations during the fourth quarter of 2020, its expectations for full year 2020 and its expectations for future performance, as well as electroCore's business prospects and clinical and product development plans for 2021 and beyond, its pipeline or potential markets for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments including human trials for the study of nVNS in COVID-19-19 patients in