electroCore, Inc. (Nasdaq: ECOR) today published a letter from the
company’s Board of Directors to shareholders. The letter is
included in its entirety, below:
Dear Shareholders:
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 United Kingdom
(UK) and the United States (US). Headache patients can now access
gammaCore therapy simply by going to our web site and filling out a
short questionnaire. The questionnaire is reviewed by a Health Care
Professional who can write prescriptions for the therapy and moved
into a shopping cart on our e-commerce storefront. After the
gammaCore product is received by the patient, our customer
experience team provides a variety of hands-on tools for patient
training and support. Our team then stays in regular contact with
the patient, providing further support during the course of the
therapy and reminders about refill opportunities.
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
Department of Veterans Affairs (VA) and Department of Defense (DoD)
business in the United States, our National Health Service (NHS)
business in the United Kingdom, and our distributor relationships
around the world. We plan to continue to invest in growth from
these channels as we move through 2022, strengthened by our
Direct-to-Consumer initiatives and advertising spend. While we
continue to work towards expanding commercial insurance coverage
for gammaCore in the United States, we recognize the barrier high
deductible plans represent for many Americans and anticipate they
will benefit significantly from our newly launched cash pay
programs, even when coverage is available.
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 $5.5 million. This
would represent an approximately 55% increase over full-year 2020
revenue of $3.5 million.
Government Channels: During the full-year 2021,
the Company expects to recognize revenue of approximately $3.3
million pursuant to the VA and DoD originating prescriptions or in
excess of 60% growth as compared to $2.0 million during the
full-year 2020. One hundred VA and DoD military treatment
facilities have purchased gammaCore products through December 31,
2021, as compared to 71 facilities through full-year 2020. With
roughly 1,800 Federal Supply Schedule (FSS) eligible treatment
facilities to which we have access, we believe the US government
channel remains a significant opportunity for revenue
generation.
Outside of the U.S.: During the year-ending
December 31, 2021, electroCore expects to recognize revenue of
approximately $1.5 million outside of the US, as compared to $1.1
million during the fiscal 2020, representing year-over-year growth
of approximately 36%. These results are primarily due to the
stellar work and dedication of our UK subsidiary, led by Iain
Strickland VP, Global Sales and Strategy, who gracefully navigated
the funding transition for our gammaCore product in England from
the NHS Innovation and Technology Payment (ITP) Program to the
MedTech Funding Mandate Policy 2021/2022.
Commercial: During the year-ending December 31,
2021, electroCore expects to recognize revenue of approximately
$680,000 or approximately 89% growth compared to $360,000 in
full-year 2020. These figures include revenues from the commercial
payer and cash pay channels in the US through our new online store,
our gConcierge, and our gCDirect programs discussed
above.
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 January 11, 2022, the Company received
Breakthrough Designation from the Food and Drug Administration for
the treatment of PTSD.
Cash: The Company ended the fourth quarter of
2021 with approximately $34.7 million of cash, cash equivalents and
marketable securities. Net cash used in operations is expected to
be approximately $13.6 million for the full-year 2021 as compared
to $20.1 million and $45.1 million reported in 2020 and 2019,
respectively.
During 2021, we accessed the capital markets to strengthen our
balance sheet by approximately $25.7 million, which will give us
the resources to make the transformational changes to our business
we envision for the future. As we move into 2022, we continue to
position the Company to take advantage of additional steps that
could expand our business including, for example through
acquisitions, by enabling the Company to access the capital markets
as opportunities warrant.
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.
About gammaCoreTMgammaCoreTM (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 the United States for
adjunctive use for the preventive treatment of cluster headache in
adult patients, the acute treatment of pain associated with
episodic cluster headache in adult patients, and the acute and
preventive treatment of migraine in adolescent (ages 12 and older)
and adult patients. gammaCore is CE-marked in the European Union
for the acute and/or prophylactic treatment of primary headache
(Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and
Hemicrania Continua) and Medication Overuse Headache in adults.
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.
The U.S. FDA has cleared the gammaCore Sapphire CV (nVNS) device
under an emergency use authorization for acute use at home or in a
healthcare setting to treat adult patients with known or suspected
COVID-19 who are experiencing an exacerbation of asthma-related
dyspnea and reduced airflow, and for whom approved pharmacologic
therapies are not tolerated or provide insufficient symptom relief
as assessed by their healthcare provider, using noninvasive vagus
nerve stimulation (nVNS) on either side of the patient's neck.
gammaCore Sapphire CV has been authorized only for the duration of
the statement that circumstances exist that warrant authorization
of the emergency use of medical devices under section 564(b)(1) of
the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is
terminated or revoked.
More information can be found at:Letter of authorization:
https://www.fda.gov/media/139967/downloadFact sheet for healthcare
workers: https://www.fda.gov/media/139968/downloadPatient
information sheet:
https://www.fda.gov/media/139969/downloadInstructions for use of
gammaCore: https://www.fda.gov/media/139970/download
Forward-Looking StatementsThis 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 Canada, Western Europe,
Qatar, Taiwan, and China) 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™, 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 SEC available at www.sec.gov.
Investors:Rich CockrellCG
Capital404-736-3838ecor@cg.capital
or
Media Contact:Jackie
DorskyelectroCore908-313-6331Jackie.dorsky@electrocore.com
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