electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today provided an operating and
business update as well as select unaudited preliminary financial
guidance for the first quarter of 2021.
“We are pleased to announce a return to strong
sequential revenue growth in the first quarter of 2021,” stated Dan
Goldberger, Chief Executive Officer of electroCore. In addition to
strong performances in the United States and the United Kingdom,
our new OUS distributor relationships have begun generating revenue
with initial orders totaling approximately $45,000 from Eastern
Europe and Australia, and initial revenue from our new Canadian
distributor is expected in the second quarter. Additionally, we
have recently announced an exclusive distribution agreement with
Silvert Medical who will distribute gammaCore™ in the Western
European countries of Belgium, Luxembourg, the Netherlands, and
France. We look forward to supporting our new OUS distribution
relationships and growing the use of gammaCore as a therapeutic
option for multiple forms of primary headache by expanding global
distribution throughout 2021.”
Operational:
Government Channels: During the
first quarter of 2021, we began to see clinician meetings with our
staff increase within the Department of Veterans Affairs (“VA”), as
the number of COVID-19 cases decreased within the system. There
have been a total of 79 VA and Department of Defense (“DoD”)
military treatment facilities that have purchased gammaCore
products through Q1 2021, as compared to 71 through the fourth
quarter of 2020 and 64 through the first quarter of 2020. Also,
during the first quarter of 2021, the company shipped approximately
1,768 paid months of therapy pursuant to VA and DoD originating
prescriptions, compared to 1,232 during the fourth quarter of 2020
and 1,084 during the first quarter of 2020.
Outside of the U.S.: During the
first quarter of 2021, electroCore shipped approximately 1,156 paid
months of therapy outside of the United States directly to
patients, as compared to 1,123 during the fourth quarter of 2020
and 1,008 during the first quarter of 2020. Note the newly engaged
distributors around the world are not included in this metric.
In January 2021, NHS England and NHS Improvement
announced that gammaCore would be included in their new long-term
reimbursement scheme titled “NHS Improvement MedTech Funding
Mandate Policy 2021/22”, which became effective on April 1, 2021.
We are working with NHS England to transition providers and
commissioners from the NHS Innovation and Technology Program (ITP)
to the MedTech Funding Mandate policy.
Similarly, in January 2021 Health Improvement
Scotland (“HIS”) published a Scottish Health Technology Group
(“SHTG”) adaptation of our NICE Medical Technology Guidance (MTG46)
for NHS Scotland on the use of gammaCore for cluster headache. The
SHTG adaptation is now being disseminated across NHS Scotland
health boards to inform the use of gammaCore for cluster
headache.
In February 2021, gammaCore’s listing in the NHS
Supply Chain catalogue was extended for an additional two years
through June 3, 2023. The NHS Supply Chain helps NHS deliver
clinically assured, quality products at the best value to its
patients and the inclusion of gammaCore in the catalogue allows
hospitals to purchase gammaCore Sapphire™ for their primary
headache patients, taking into account their own budgetary
restrictions. The listing of gammaCore Sapphire as an e-Direct
product marks an important milestone in the Company’s provision of
its medical technologies to UK patients, in an easy, cost-effective
way.
In recent months, we took meaningful steps to
expand gammaCore’s global availability. In December, we announced
an exclusive distribution agreement with Pro Medical Baltic to
distribute gammaCore in Eastern Europe, including Lithuania,
Latvia, Belarus, Kazakhstan, Ukraine, and most recently, Romania.
In January, we entered into a similar agreement with RSK Medical in
Canada, and in February, we announced an agreement with Medistar to
serve as the exclusive distributor for gammaCore in Australia. Most
recently, in March 2021 we announced an exclusive distribution
agreement with Silvert Medical to make gammaCore therapy available
in certain Western Europe countries such as Belgium, Luxembourg,
the Netherlands, and France. We look forward to further expanding
our global network with leading medical technology distribution
partners to make gammaCore more broadly available outside the USA
throughout 2021.
Commercial: The company
continues to make measured investments in its Commercial
channel.
In January 2021, we announced that CMS published
its most recent Level II Healthcare Common Procedure Coding System,
commonly known as HCPCS, establishing a unique code “K1020” for
“Non-invasive vagus nerve stimulator.” All final coding decisions
for the second biannual 2020 Coding Cycle for non-drug and
non-biological items and services went into effect on April 1,
2021. We view the establishment of a unique HCPCS code for
non-invasive vagus nerve stimulation (“nVNS”) as an important
differentiator, and a potentially significant step forward in
obtaining additional coverage of our proprietary nVNS therapy
within the medical benefit pathway.
Research and Development:
During the first quarter of 2021, we announced that the FDA cleared
our 510(k) submission to expand the gammaCore label to include the
acute and preventive treatment of migraine in adolescents between
12 and 17 years of age.
In February 2021, we announced that full
enrollment had been achieved in the investigator-initiated TR-VENUS
study evaluating the utility of nVNS for the acute treatment of
stroke. We look forward to reporting data from the TR-VENUS trial
later this year.
Also, in February 2021, we announced publication
of a study in the journal Colorectal Disease that further
demonstrates the broad potential of nVNS. The study evaluated the
effectiveness of nVNS in preventing post-operative ileus following
major elective colorectal surgery. The results detailed in this
paper strongly support continued development in this indication and
a larger study funded by the National Institute for Health Research
in England is ongoing.
Lastly, we recently announced preliminary
results from 110 hospitalized patients enrolled in the
investigator-initiated SAVIOR-1 trial in Valencia, Spain, which is
evaluating nVNS as a potential treatment for COVID-19. nVNS was
well tolerated with no major device-related adverse events and the
results suggest nVNS that could be a viable treatment for patients
and possibly help decrease symptoms early in the course of the
disease. Full results are expected to be published in a
peer-reviewed journal later this year.
We will continue to provide updates on the
progress of ongoing gammaCore investigator-initiated trials in a
variety of conditions as they become available.
Financial Guidance:
electroCore today announced the following
preliminary unaudited financial guidance for the first quarter of
2021:
First Quarter 2021 Revenue:
electroCore anticipates that first quarter 2021 revenue will be
more than $1.1 million, representing greater than 50% growth over
first quarter 2020 revenue of $0.7 million and greater than 20%
growth over fourth quarter 2020 revenue of $0.9 million.
March 31, 2021 cash: The
company ended the first quarter of 2021 with approximately $25.5
million of cash, cash equivalents and marketable securities,
compared to $22.6 million as of December 31, 2020. The company
raised $6.9 million during the quarter under a stock purchase
agreement. That stock purchase agreement was voluntarily terminated
by the company before the end of the first quarter. This capital
raise was offset by net cash used of approximately $4.1 million to
fund operations during the first quarter of 2021.
The company intends to provide a detailed
operational and financial update during its first quarter 2021
earnings call in May.
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 and the acute treatment of migraine
and episodic cluster headache.
For more information, visit www.electrocore.com.
About gammaCoreTM
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 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 contraindications include but are not
limited to:
- Patients with an active implantable medical device, such as a
pacemaker, hearing aid implant, or any implanted electronic
device
- Patients with a metallic device, such as a stent, bone plate or
bone screw, implanted at or near the neck
- Patients who 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:
- 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 of age)
- 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/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
Forward-Looking Statements
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 first quarter of
2021, 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 Spain, the U.S., or elsewhere, and
the business, operating or financial impact of such studies),
further international expansion, and statements about anticipated
distribution arrangements, government funding arrangements
(including those relating to NHS England, HIS and SHTG) 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 Cockrell
CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com
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