Full Press Release Details
electroCore Provides Business Update
and Select Financial Guidance
BASKING RIDGE, N.J., July 14, 2020
-- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an operating
and business update as well as select unaudited financial guidance for the second quarter and full year 2020.
"During the second quarter, the COVID-19
pandemic continued to impair business operations around the world, and as a result like many companies, we both anticipated and
experienced some impact to our performance," stated Dan Goldberger, Chief Executive Officer of electroCore. "While
our overall revenues were up sequentially and achieved our guidance of being in excess of $700,000 in the quarter, paid months
of therapy shipped to both the VA/DoD and outside the U.S. (OUS) channels were down modestly on a sequential basis as providers
pivoted to help fight the pandemic, patient and provider appointments were cancelled, and travel and other restrictions were implemented.
However, temporary softness in these channels was in part offset by replenishment orders from our specialty pharmacy partner. Additionally,
the pandemic has presented us with an opportunity to explore the potential utility of non-invasive nerve stimulation technology
in treating respiratory symptoms related to COVID-19. Taken together, we believe we are well positioned for a strong second half
of the year as key revenue channels return to positive growth if a more normalized business environment emerges."
COVID-19: The company recently announced
that it has been granted an Emergency Use Authorization (EUA) by the FDA to facilitate the study and clinical use of gammaCoreTM
CV for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients. The EUA is supported by data from early
clinical and non-clinical work in several pilot studies that involved patients with a variety of respiratory disorders.
Additionally, two investigator-initiated
clinical trials (IITs) of gammaCore in COVID-19 patients continue to enroll subjects - one at Hospital Cl nico
Universitario de Valencia in Valencia, Spain (SAVIOR 1) and the other at Allegheny Medical Center in Pittsburgh (SAVIOR 2). These
trials are designed to study the potential for gammaCore (nVNS) to treat the respiratory symptoms and underlying inflammation
affecting COVID-19 patients. Both trials continue to enroll patients and are largely funded by third party grants. Data will be
reported as they become available. Additional U.S. investigator-initiated COVID-19 trials are under consideration.
Federal Supply Schedule: During
the second quarter of 2020, 67 Department of Veterans Affairs (VA) and Department of Defense (DoD) military treatment facilities
purchased gammaCore products as compared to 64 during the first quarter of 2020, 54 during the fourth quarter of 2019, 48
during the third quarter of 2019 and 35 during the second quarter of 2019. Also, during the second quarter of 2020, the company
shipped approximately 988 paid months of therapy pursuant to VA and DoD originating prescriptions, compared to 1,084 paid months
of therapy during the first quarter of 2020, 829 during the fourth quarter of 2019, 553 during the third quarter of 2019 and 233
during the second quarter of 2019.
As the company indicated in its earnings
announcement in May 2020, in light of the ongoing pandemic, the company's ability to visit hospitals and doctors has been
limited, and according to VA officials, some 5.7 million appointments with VA providers were cancelled between February and April.
Partly offsetting this is the VA's advanced telehealth capabilities, which have increased almost tenfold from 2,500 daily
sessions in early March to nearly 25,000 current daily sessions , according to the Federal News Network. gammaCore can be
prescribed easily during a telehealth consult and delivered directly to the patient's home, and this has allowed us to navigate
through the crisis with only a modest sequential reduction in paid months of therapy. In light of these recent challenges, the
trajectory of this business channel remains difficult to forecast into the remainder of the year. We believe, however, that our
performance during the second quarter represents a strong leading indicator and gives us conviction that this important channel
will rebound strongly when and if the pandemic subsides.
Outside of the U.S.: During the
second quarter of 2020, electroCore shipped approximately 938 paid months of therapy outside of the United States, as compared
to 1,008 during the first quarter of 2020, 961 during the fourth quarter of 2019 and 828 during the third quarter of 2019. The
modest sequential decline was driven by COVID-19 related disruptions and discontinued operations in Germany.
Commercial: The inventory placed
in the commercial channel during 2019 has been fully dispensed by our specialty pharmacy partner. As a result, the company shipped
a small replenishment order in June. The company expects further contribution from replenishment orders in coming quarters.
Clinical: As previously disclosed,
electroCore recently made the decision to terminate the PREMIUM 2 clinical trial. There are currently no company-funded trials
ongoing, but as previously indicated, multiple IITs are active and more are under consideration. In addition to COVID-19/reactive
airway disease, gammaCore IITs are progressing in stroke, subarachnoid hemorrhage and Sjogren's syndrome.
electroCore today announced the following
preliminary unaudited financial guidance for the second quarter of 2020:
Q2 2020 revenue: The company expects
second quarter 2020 total revenue to be approximately $730,000 to $750,000, as compared to first quarter 2020 total revenue of
Q2 2020 cash used in operations: During
the second quarter, electroCore used approximately $5.5 million to fund its operations, not including $1.1 million received in
connection with its sale of New Jersey net operating losses, as compared to $8.4 million in the first quarter of 2020 and $9.4
million in the fourth quarter of 2019.
June 30, 2020 cash: The company
ended the first quarter of 2020 with approximately $18.9 million of cash, cash equivalents and marketable securities.
About electroCore, Inc.
electroCore, Inc. is a commercial-stage
bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation
therapy initially focused on the treatment of multiple conditions in neurology. The company's current indications are for
the preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
(nVNS) is the first non-invasive, hand-held medical therapy
applied at the neck 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 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, the acute treatment of pain associated with migraine headache in adult
patients and the prevention of migraine in 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),
Bronchoconstriction and Medication Overuse Headache in adults.
In the U.S., the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute
respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for
all of the important warnings and precautions before using or prescribing this product available at www.gammacore.com.
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 second
quarter of 2020, its expectations for full year 2020 and its expectations for future performance, as well as electroCore's business
prospects and clinical and product development plans, its pipeline or potential markets for its technologies, the timing, outcome
and impact of regulatory, clinical and commercial developments including potential human trials for the study of nVNS in COVID-19
patients in Spain, the U.S., or elsewhere, the business, operating or financial impact of such studies, 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