electroCore Announces Shareholder Letter and Full-Year 2021 Business Update
We continue to be excited about the long-term prospects of our Company and would like to share some of the reasons for our optimism.
We are investing in marketing initiatives that we believe will make our gammaCore™ therapy available directly to consumers through multiple channels at a very compelling price. Among these channels are our newly launched e-commerce storefronts in the
In parallel with our online stores, we have launched our gConcierge and gCDirect programs for a growing number of physician prescribers in the US. These new programs allow physicians to offer their patients the opportunity to purchase gammaCore therapy directly through their offices (gConcierge) or directly from us (gCDirect). We have broadened our call points from the traditional neurology headache specialists to include a wider range of medical providers who manage patients’ headache conditions, including those in primary care, women’s health, pain management, functional and integrative medicine, as well as chiropractors and Doctor of Pharmacy (PharmDs). In total, we have had approximately 200 prescribers write scripts through the gConcierge and gCDirect programs, all of whom have patients that can be supported by our in-house customer experience team.
With the early growth and promise of success among these newly established, streamlined consumer access initiatives, we are planning to aggressively ramp up our spending on Direct-to-Consumer advertising and other promotional activities. Our goal is to drive consumer awareness and funnel that interest to our e-commerce stores and provider partners.
In our legacy business channels, we have continued to grow our
Looking beyond primary headache, we anticipate reporting on our multiple clinical programs over the course of 2022. Ongoing trials continue to be conducted with our gammaCore therapy in secondary headache, traumatic brain injury (concussion), post traumatic stress disorder (PTSD), stroke, opioid use disorder, Parkinson’s, postoperative ileus, and other potential indications. We anticipate many of these programs will generate results that can support expanded labels and additional uses for gammaCore nVNS therapy, and support potentially expanded total addressable markets for our therapy. We believe nVNS therapy will be highly differentiated in conditions like concussion, PTSD, stroke, and opioid use disorder where there are few effective therapies currently.
Finally, as we expand our commercial initiatives, we are also looking beyond organic growth opportunities and exploring ways to accelerate our growth through acquisitions that enhance and leverage the distribution channels we are developing.
We have also continued to expand our intellectual property portfolio, especially in digital health and smartphone-integrated and smartphone-connected non-invasive therapy, which may provide us with opportunities to leverage our patents. We believe our intellectual property will be the foundation of next generation neuromodulation devices in the market, including our own nVNS devices.
We look forward to enabling health care providers in their use of Remote Patient Monitoring and Remote Therapeutic Monitoring, which have been identified as critical areas for practice revenue growth in the future.
Preliminary Unaudited Financial Results for Full-Year 2021
Full-Year 2021 Revenue: electroCore anticipates full-year 2021 revenue will be approximately
Government Channels: During the full-year 2021, the Company expects to recognize revenue of approximately
Outside of the
Commercial: During the year-ending
Research and Development: During fiscal 2021, the Company continued to make progress across its clinical programs. The Company received four new 510(k) clearances. Additionally, on
Cash: The Company ended the fourth quarter of 2021 with approximately
During 2021, we accessed the capital markets to strengthen our balance sheet by approximately
We are proud of the progress we have made and are excited about the future. Thank you for your continued support.
With best wishes,
electroCore Board of Directors
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company's current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.
For more information, visit www.electrocore.com.
gammaCoreTM (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 (nVNS) is FDA cleared in
gammaCore is contraindicated for patients 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 the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Adolescent patients with congenital cardiac issues
- 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 (less than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
More information can be found at:
Letter of authorization: https://www.fda.gov/media/139967/download
Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download
Patient information sheet: https://www.fda.gov/media/139969/download
Instructions for use of gammaCore: 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 and full year of 2021, growth through acquisitions, its expectations for future performance, as well as electroCore's business prospects (including its e-commerce initiative, and gConcierge and gCDirect programs) and clinical and product development plans for 2022 and beyond, its pipeline or potential markets (including cash pay programs) 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 headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to