electroCore Provides Business Update and Select Financial Guidance
Third quarter 2020 Revenue expected to exceed
Operating cash burn for the third quarter 2020 of approximately
“During the third quarter, we again demonstrated our ability to adapt to a rapidly changing business environment and maintain our focus despite the ongoing pandemic, resulting in a greater than 35% sequential increase in total revenue to more than
COVID-19: The launch of gammaCore Sapphire™ CV for treatment of known or suspected COVID patients under the previously announced Emergency Use Authorization is proceeding. gammaCore Sapphire CV is available by prescription through our
Federal Supply Schedule: During the third quarter of 2020, 68
In light of the ongoing COVID-19 pandemic, the company’s ability to visit
Outside of the
Commercial: During the first half of 2020, the company restructured and streamlined its commercial distribution channel. All of the inventory placed in the commercial channel during 2019 was fully dispensed by
mTBI/PTSD VA Study. In the quarter ended
Please refer to https://clinicaltrials.gov/ct2/show/NCT04437498 for more information.
Clinical: In addition to COVID-19, gammaCore™ investigator initiated trials continue to progress in stroke, subarachnoid hemorrhage, certain rheumatologic conditions, and as outlined above, in mTBI/PTSD which is supported by the
electroCore today announced the following preliminary unaudited financial guidance for the third quarter of 2020:
Q3 2020 revenue: The company expects third quarter 2020 total revenue to be greater than
Q3 2020 cash flow: Operating cash burn for the third 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 third 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, its pipeline or potential markets for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments including potential human trials for the study of nVNS in COVID-19 patients in