Full Press Release Details
electroCore Provides
Business Update and Select First Quarter 2021 Financial Guidance
2021 revenue expected to be more than $1.1 million
for the first quarter 2021 of approximately $4.1 million
April 13, 2021 -- 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.
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."
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.
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.
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.
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.
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.
The company continues to make measured investments in its Commercial channel.
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.
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.
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.
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.
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.
to provide updates on the progress of ongoing gammaCore investigator-initiated trials in a variety of conditions as they become available.
announced the following preliminary unaudited financial guidance for the first quarter of 2021:
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.
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.
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.
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.
(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.
contraindications include but are not limited to:
of gammaCore have not been evaluated in the following patients:
the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
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.
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
information can be found at:
of authorization: https://www.fda.gov/media/139967/download
sheet for healthcare workers: https://www.fda.gov/media/139968/download
information sheet: https://www.fda.gov/media/139969/download
Instructions for use of gammaCore: