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
second quarter of 2021.
“We are pleased to announce preliminary second quarter results,
which were in line with our expectations,” stated Dan Goldberger,
Chief Executive Officer of electroCore. “Revenue for the quarter
ended June 30, 2021 is expected to be approximately $1.3 million.
Our headache markets in the US and UK continue to emerge from the
pandemic and we look forward to accelerating revenue in the
future.” Operational:Government
Channels: During the second quarter of 2021, the company
expects to recognized revenue of approximately $779,000 pursuant to
the Department of Veterans Affairs (“VA”) and Department of Defense
(“DoD”) originating prescriptions, compared to $679,000 during the
first quarter of 2021 and $415,000 second quarter of 2020. 85 VA
and DoD military treatment facilities have purchased gammaCore
products through June 30, 2021 as compared to 79 through the first
quarter 2021 and 67 through the second quarter of
2020. Outside of the U.S.: During the second
quarter of 2021, electroCore expects to recognize revenue of
approximately $369,000 outside of the United States through direct
channels, as compared to $335,000 during the first quarter of 2021
and $247,000 during the second quarter of 2020. These figures do
not include new global stocking distributors which contributed
revenues from Canada and Western Europe during the second quarter
of 2021.
The company continues to expand its distributor relationships
internationally. In April 2021, the company announced that East
Agency will serve as the exclusive distributor of the gammaCore
Sapphire™ non-invasive vagus nerve stimulator (“nVNS”) in Qatar. In
June, the Company announced a distribution agreement with Kromax
International Corporation to serve as the exclusive distributor of
gammaCore Sapphire™ (nVNS) in Taiwan and China.
Commercial: The company continues to make
targeted investments in its Commercial channel. In January 2021,
CMS published its Level II Healthcare Common Procedure Coding
System, commonly known as HCPCS, including a unique code “K1020”
for “Non-invasive vagus nerve stimulator,” which went into effect
on April 1, 2021. During the second quarter, the company received a
favorable coverage determination from a regional payor and
continues to work on obtaining additional positive medical benefit
coverage decisions.
Research and Development: There were several
important research and development advancements related to
gammaCore during the second quarter of 2021.
In April 2021, the company announced the publication of a paper,
entitled, “Cluster headache pathophysiology — insights from current
and emerging treatments,” by Drs. Diana Wei and Peter Goadsby in
Nature Reviews: Neurology. The paper reviews data on existing and
emerging treatments for the acute and preventive treatment of
cluster headache. Among the emerging treatments, electroCore’s
gammaCore is identified as the only therapy that has been shown to
be effective in clinical trials for both the acute treatment of
episodic cluster headache as well as the preventive treatment of
cluster headache. In May 2021, the U.S. Department of Veterans
Affairs announced an investigator-initiated study of the use of
gammaCore SapphireTM (nVNS) for the treatment of post-traumatic
headache (“PTH”). PTH accounts for approximately 4% of all
symptomatic headache disorders and is one of the most common
consequences of mild traumatic brain injury (mTBI), also known as
concussion.
In June 2021, the company announced publication of a
peer-reviewed paper, entitled “Non-Invasive Vagus Nerve Stimulation
Improves Clinical and Molecular Biomarkers of Parkinson’s Disease
in Patients with Freezing of Gait” in the journal NPJ Parkinson’s
Disease. The paper reports the results of a randomized,
double-blind, sham-controlled crossover trial conducted at the
Institute of Neurosciences in Kolkata, India in collaboration with
the Faculty of Medical Sciences at Newcastle University in England
using gammaCore SapphireTM. The study provides preliminary evidence
supporting the safety and efficacy of nVNS in treating motor and
non-motor symptoms of Parkinson’s Disease. Patients were reportedly
satisfied with the treatment and the majority were able to
self-administer nVNS.
On June 10, 2021 the company announced the publication of a
peer-reviewed paper entitled “Effects of Transcutaneous Vagal Nerve
Stimulation (tVNS/nVNS) on Cognitive Performance under Sleep
Deprivation Stress,” in the journal Communications Biology, a
Nature publication. The paper reports the ability of gammaCore to
reduce fatigue and increase performance in a randomized,
double-blind, sham-controlled trial conducted at Wright-Patterson
Air Force Base using gammaCore and sponsored by the United States
Air Force Research Laboratories (USAFRL).
Financial Guidance: electroCore today announced
the following preliminary unaudited financial guidance for the
second quarter of 2021:
Second Quarter Revenue: electroCore anticipates
that second quarter 2021 revenue will be approximately $1.3
million. This represents a 5% increase over first quarter 2021
revenue of $1.2 million and 69% growth over second quarter 2020
revenue of $753,000.
June 30, 2021 Cash: The company ended the
second quarter of 2021 with approximately $23.7 million of cash,
cash equivalents and marketable securities, compared to $25.5
million as of the end of the first quarter 2021. During the second
quarter of 2021, the company received approximately $1.4 million in
non-dilutive cash from the sale of New Jersey net operating loss
tax benefits. The $1.4 million of cash proceeds were offset by net
cash used of approximately $3.2 million to fund operations during
the second quarter of 2021. The cash balance at June 30, 2021
excludes approximately $18.8 million raised in the recent public
offering (after deducting underwriting discounts and commissions
and estimated offering expenses payable by the Company) which
closed subsequent to the end of the quarter.
The company intends to provide a detailed operational and
financial update during its second quarter 2021 earnings call in
August 2021.
Mr. Goldberger commented further, “We continue to be
enthusiastic about the prospects of the business. We have a
strong balance sheet which will support our continued efforts to
educate and improve physician and patient awareness, which we
believe will ultimately lead to the successful adoption of
gammaCore globally.” 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 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:
- 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 second 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 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 Cockrell
CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Jackie Dorsky
electroCore
908-313-6331
jackie.dorsky@electrocore.com
electroCore (NASDAQ:ECOR)
Gráfico Histórico do Ativo
De Jun 2024 até Jul 2024
electroCore (NASDAQ:ECOR)
Gráfico Histórico do Ativo
De Jul 2023 até Jul 2024