Full Press Release Details
electroCore Announces First Quarter 2021 Financial
Record First quarter 2021 net sales of $1.2
million, increased 64% over first quarter 2020 and 30% sequentially
Company to host a conference call and webcast
today, May 6, 2021 at 4:30 pm ET
May 6, 2021 at 4:05 pm ET
ROCKAWAY, NJ, - electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, announced first quarter 2021 financial results and provided an operational update.
First Quarter 2021 and Recent Highlights
| - | Posted revenue of $1.2 million, representing an increase of 64% over first quarter 2020 and 30% sequentially; | ||
| - | Net cash used was $4.1 million during the first quarter 2021 leaving approximately $25.5 million of cash, cash equivalents, and marketable securities at March 31, 2021; | ||
| - | Secured unique CMS Level II HCPCS reimbursement code for "Non-invasive vagus nerve stimulator"; | ||
| - | Announced inclusion of gammaCore in the new NHS England and NHS Improvement MedTech Funding Mandate Policy 2021/22, and two-year extension of gammaCore listing in the NHS Supply Chain Catalogue; | ||
| - | Announced Scottish Health Technology Group recommendation for use of gammaCore in NHS Scotland cluster headache patients; | ||
| - | Executed distribution agreements with RSK Medical, Medistar, Silvert Medical and East Agency for distribution of gammaCore Sapphire in Canada, Australia, Western Europe, and Qatar, respectively; and | ||
| - | Obtained 510(k) clearance of gammaCore from the FDA to expand its indication into preventative and acute treatment of adolescent migraine (ages 12-17). |
Dan Goldberger, Chief Executive Officer of electroCore,
commented: "During the quarter, we demonstrated continued progress in operating metrics across all of our revenue channels, despite
the challenges and headwinds of the pandemic. We delivered 64% year-over-year revenue growth in the quarter, we achieved a major U.S.
reimbursement milestone in the establishment of a unique Level II HCPCS code for Non-invasive vagus nerve stimulator,' we
increased the number of signed ex-U.S. distribution agreements, we continued expanding the FDA cleared gammaCore indications
for use to include adolescents suffering from migraine, we announced publications highlighting the power of nVNS as a platform in the
Journal of Colorectal Disease for post-operative ileus and Nature Reviews as an emerging treatment for cluster headache, we saw topline
results in the SAVIOR-1 investigator initiated trial, and the progression of clinical trials in four additional indications: stroke, post-operative
ileus, opioid use disorder, and post traumatic headache, and we realized continued support by NHS England to cover gammaCore therapy through
inclusion in the new NHS Improvement MedTech Funding Mandate."
taken steps to pursue continued growth of gammaCore in our core revenue generating channels while working to establish and capitalize
on new opportunities. gammaCore has broad potential utility across a very diverse range of indications, and along with the entire electroCore team,
I remain committed to making this therapy available to every individual who can potentially benefit from it."
able to demonstrate continued momentum across our business while also maintaining discipline around expense and cash management. We believe
our cash balance of $25.5 million at March 31, 2021 provides a solid pathway to execute our plan into 2022."
First Quarter 2021 Financial Results
For the quarter ended March 31, 2021, electroCore
reported net sales of $1.2 million compared to $928,000 in the fourth quarter of 2020 and $734,000 during same period of 2020.
Revenue from the Department of Veterans Affairs
("VA") and Department of Defense ("DOD") increased 33% sequentially to $679,000 in the first quarter of 2021 from
$509,000 in the fourth quarter of 2020 and increased 49% as compared to $454,000 in the first quarter of 2020. Paid months of therapy
shipped to the VA and DOD increased 44% sequentially to 1,768 in the first quarter of 2021 from 1,232 in the fourth quarter of 2020 and
increased 63% as compared to 1,084 in the first quarter of 2020.
Revenue from outside the United States increased
sequentially by 22% to $380,000 in the first quarter of 2021 from $311,000 in the fourth quarter of 2020 and increased 38% as compared
to $276,000 in the first quarter of 2020. First quarter 2021 OUS revenue included initial orders from our new distributors in Eastern
Europe and Australia. Paid months of therapy shipped directly to patients outside the United States increased 1% sequentially to 1,156
from 1,143 in the fourth quarter of 2020 and 15% from 1,008 in the first quarter of 2020.
Gross profit for the first quarter of 2021 was
$840,000 as compared to $109,000, for the fourth quarter of 2020 and $436,000 for the first quarter of 2020. Gross profit for the fourth
quarter of 2020 was reduced by an increase in inventory reserves of $434,000. Gross margin for the first quarter of 2021 was 70%, compared
to 59% (excluding the increase in inventory reserves) in the fourth quarter of 2020 and 59% in the first quarter of 2020.
Total operating expenses in the first quarter
of 2021 were approximately $6.2 million, a reduction of approximately $200,000 from $6.4 million in the fourth quarter of 2020 and a reduction
of $2.2 million from $8.4 million in the first quarter of 2020.
Research and development expense in the first
quarter of 2021 was $500,000, as compared to $1.0 million in the fourth quarter of 2020, a reduction of approximately $1.0 million from
$1.5 million in the first quarter of 2020.
Selling, general and
administrative expense in the first quarter of 2021 was $5.7 million as compared to $5.4 million in the fourth quarter of 2020. Selling,
general and administrative expense decreased by 13% from $6.6 million in the first quarter of 2020.
GAAP net loss in the
first quarter of 2021 was $5.4 million compared to fourth quarter 2020 GAAP net loss of $6.3 million. GAAP net loss decreased by 33% or
$2.6 million as compared to a GAAP net loss of $8.0 million in the first quarter of 2020.
Adjusted EBITDA net loss
in the first quarter of 2021 was $4.2 million as compared to $4.3 million during the fourth quarter of 2020 and as compared to a loss
of $6.4 million in the first quarter of 2020.
The company defines adjusted
EBITDA net loss as GAAP net loss, excluding depreciation and amortization, stock-compensation expense, restructuring and other severance
related charges, legal fees associated with stockholders' litigation and total other income/expense. A reconciliation
of GAAP net loss to Non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in this press release.
Net cash used in the
quarter ended March 31, 2021, exclusive of financing activities, was approximately $4.1 million, as compared to $3.7 million in the fourth
quarter of 2020, and $8.4 million in the first quarter of 2020.
Cash, cash equivalents
and marketable securities at March 31, 2021 totaled approximately $25.5 million, as compared to approximately $22.6 million at December
31, 2020. The company raised $6.9 million during the first quarter of 2021 under a stock purchase agreement that was voluntarily terminated
by the company before the end of the first quarter.
For the second quarter
of 2021, the Company expects net revenue to exceed $1.2 million and net cash usage, exclusive of financing activities, to approximate
Webcast and Conference Call Information
electroCore's management team will
host a conference call today, May 6, 2021, beginning at 4:30pm ET.
Investors interested in listening to the conference
call, or webcast may do so by dialing 877-269-7756 for domestic callers or 201-689-7817 for international callers,
using Conference ID: 13718262, or by connecting to the Web: electroCore 1Q21 Business Update Webcast
An archived webcast of the event
will be available on the "Investors" section of the company's website at: www.electrocore.com.
gammaCore (nVNS) is the first non-invasive
manual medical therapy delivered to the neck as adjunctive therapy to treat migraine and cluster headache using mild electrical stimulation
of 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 medications. When placed on the patient's
neck over the vagus nerve, gammaCore stimulates afferent nerve fibers, which can lead to a reduction in pain for patients.
gammaCore is cleared by the FDA in the United
States for adjunctive use in 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 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 Continuous Hemicrania) and Drug Use Headache in adults. In 2019, NICE
published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within the NHS
In the United States, the FDA has not cleared
gammaCore for the treatment of pneumonia and/or respiratory disorders, such as COVID-19-associated acute respiratory stress disorder.
Refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.
The U.S. FDA has cleared 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
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, available under an emergency access mechanism called EUA.
gammaCore Sapphire CV has not been cleared
or approved for acute use in the home or 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