Full Press Release Details
electroCore Provides Business Update
and Select Financial Guidance
Third quarter 2020 Revenue expected to
exceed $1 million, representing an increase of greater than 35% sequentially and greater than 50% over Q3 2019
Operating cash burn for the third quarter
2020 of approximately $4.1 million
BASKING RIDGE, N.J., October 13,
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 third quarter.
"During the third quarter, we again
demonstrated our ability to adapt to a rapidly changing business environment and maintain our focus despite the ongoing pandemic,
resulting in a greater than 35% sequential increase in total revenue to more than one million dollars," stated Dan Goldberger,
Chief Executive Officer of electroCore. "Our key revenue channels, notably the VA/DoD and United Kingdom, continued to perform
well. While our COVID-19 initiatives did not contribute material revenue during the quarter, our physician and patient outreach
efforts under our Emergency Use Authorization are ongoing. We are also very pleased that the VA is sponsoring a study of gammaCore
Sapphire in veterans with co-morbid traumatic brain injury and Post-Traumatic Stress Disorder. This work could lead to another
potentially high-value indication for nVNS. We believe we are well positioned to finish the year and to enter 2021 with renewed
momentum across all of our revenue channels."
COVID-19: The launch of gammaCore
SapphireTM CV for treatment of known or suspected COVID patients under the previously announced Emergency Use Authorization
is proceeding. gammaCore Sapphire CV is available by prescription through our VA/DoD channels, from Premier Specialty Pharmacy,
and access to telehealth consults from health care providers are being offered through the UpScript telehealth portal at www.getgammacore.com.
We are pleased with the level of interest this initial launch has generated for both gammaCore Sapphire CV as well as our headache
products. As our understanding of the disease has evolved and in-patient treatment regimens have changed, the enrollment criteria
for SAVIOR 1 and SAVIOR 2 trials in hospitalized COVID patients have proven to be more challenging than originally anticipated.
We continue to monitor COVID-19 levels near the two sites conducting the study and are discussing possible modifications to the
protocol with the Investigators.
Federal Supply Schedule: During
the third quarter of 2020, 68 Department of Veterans Affairs (VA) and Department of Defense (DoD) military treatment facilities
purchased gammaCore products as compared to 67 during the second quarter of 2020, 64 during the first quarter of 2020, 54
during the fourth quarter of 2019 and 48 during the third quarter of 2019. Also, during the third quarter of 2020, the company
shipped approximately 1,600 paid months of therapy pursuant to VA and DoD originating prescriptions, compared to 988 paid months
of therapy in the second quarter of 2020, 1,084 paid months of therapy during the first quarter of 2020, 829 during the fourth
quarter of 2019 and 553 during the third quarter of 2019.
In light of the ongoing COVID-19 pandemic,
the company's ability to visit VA doctors and facilities remains limited. However, the VA quickly and effectively adopted
telehealth capabilities, with the number of daily sessions increasing more than 10x since the start of the pandemic, according
to a news release from the Office of Public and Intergovernmental Affairs. The company continues to navigate through this challenging
business environment and remains well positioned to resume all available outreach activities if and when the pandemic subsides.
Outside of the U.S.: During the
third quarter of 2020, electroCore shipped approximately 1,020 paid months of therapy outside of the United States, as compared
to 938 paid months of therapy during the second quarter of 2020 and 1,008 during the first quarter of 2020.
Since April 2019, gammaCore has been reimbursed
by NHS England's Innovation and Technology Payment (ITP) Program for the treatment of cluster headache in adults. The ITP
Program is designed to support the adoption of innovations and technologies in the NHS market through the removal of significant
financial barriers for both commissioners and providers. Earlier this month, the ITP Program for gammaCore was again extended for
a six-month period through March 1, 2021 with the option for three additional years. The total contract value, assuming exercise
of the three-year option, could be up to approximately $4.6 million at recent exchange rates. Perhaps more importantly, the company
views this extension as another meaningful validation of nVNS technology. More than 55,000 adults in the U.K. suffer from cluster
headache, a truly debilitating condition with few effective treatment options.
Commercial: During the first half
of 2020, the company restructured and streamlined its commercial distribution channel. All of the inventory placed in the commercial
channel during 2019 was fully dispensed by June 30, 2020. As a result, the company was able to recognize a full quarter of replenishment
orders during the period ended Sep 30, 2020. The company is monitoring pharmacy inventory on an ongoing basis and expects ongoing
contribution from commercial replenishment orders in the coming quarters.
mTBI/PTSD VA Study. In the quarter
ended September 30, 2020, the company was notified that the VA has agreed to sponsor a quadruple blind, randomized, sham-controlled
clinical trial of nVNS as a potential treatment for mild traumatic brain injury (mTBI) and Post-Traumatic Stress Disorder. The
trial is being sponsored by the VA s Office of Research and Development at the Atlanta VA Medical Center. mTBI and PTSD are
of significant concern for the VA in light of recent conflicts in Iraq and Afghanistan, and it is estimated that up to 56% of mTBI
patients have co-morbid PTSD, making the combined conditions more common than each individually. This is an important study for
the company with the potential to introduce gammaCore in an entirely new indication and further leverage the company's existing
relationship with the VA.
Please refer to https://clinicaltrials.gov/ct2/show/NCT04437498
for more information.
Clinical: In addition to COVID-19,
gammaCore investigator initiated trials continue to progress in stroke, subarachnoid hemorrhage, certain rheumatologic conditions,
and as outlined above, in mTBI/PTSD which is supported by the VA.
electroCore today announced the following
preliminary unaudited financial guidance for the third quarter of 2020:
Q3 2020 revenue: The company expects
third quarter 2020 total revenue to be greater than $1 million.
Q3 2020 cash flow: Operating cash
burn for the third quarter of 2020 is expected to be approximately $4.1 million. In addition, during the three months ended September
30, 2020 the company raised approximately $11.2 million through its existing stock purchase agreement with Lincoln Park Capital.
September 30, 2020 cash: The company
ended the third quarter of 2020 with approximately $26.0 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.
The United States FDA has authorized use of the gammaCore Sapphire
CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing