electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic
medicine company, today announced fourth quarter and full year 2021
financial results and provided an operational update.
Fourth Quarter 2021 and Recent Highlights
- Reported full year 2021 net sales of approximately $5.5
million, representing an increase of 56% over $3.5 million for full
year 2020;
- Fourth quarter net sales of approximately $1.5 million, an
increase of 61% over the fourth quarter of 2020;
- Net cash used to fund operations was approximately $13.6
million for full year 2021, representing a 32% decrease compared to
full year 2020;
- Cash on hand as of December 31, 2021, totaled approximately
$34.7 million;
- Launched a new online shop in the United Kingdom for consumers
suffering from menstrual migraine to purchase gammaCore
Saphhire™;
- Launched a new telehealth portal and e-commerce store in the
United States for consumers to purchase gammaCore
Saphhire™;
- Received breakthrough device designation from the FDA for the
treatment of PTSD; and
- Top line data from three abstracts was presented at the
American Heart Associations’ 2022 International Stroke Conference
on the possible role of nVNS in the acute treatment of stroke.
Dan Goldberger, Chief Executive Officer of electroCore,
commented: “I am thrilled about long-term prospects of our Company.
Our fourth quarter revenue grew 61% year-over-year while we
delivered 56% annual revenue growth for the full year. We continue
to make our gammaCore therapy more broadly available around the
world.”
“We are making select investments in cash pay initiatives that
we believe will make our gammaCore therapy available directly to
consumers through a growing number of physician prescribers in the
United States, as well as through ecommerce platforms in both the
US and UK.”
“I believe we have made significant progress towards making our
gammaCore therapy available directly to consumers through multiple
channels, and we plan to further invest in awareness campaigns
through advertising and promotional activities. We continue to
conduct clinical programs across a diverse range of indications
including secondary headaches, traumatic brain injury, PTSD,
stroke, opioid use disorder, Parkinson’s, and postoperative ileus.
Lastly, we are exploring growth opportunities to enhance and
leverage distribution channels through acquisitions. With a cash
and cash equivalents balance of $34.7 million at December 31, 2021,
we believe there is substantial runway to execute our plan into the
future.”
Fourth Quarter and Full Year 2021 Financial
ResultsFor the quarter ended December 31, 2021,
electroCore reported net sales of approximately $1.5 million
compared to $928,000 in the same period of 2020. For the full year
2021, the Company reported net sales of approximately $5.5 million,
as compared to net sales of approximately $3.5 million for the full
year 2020.
Net sales from the Department of Veterans Affairs (VA) and
Department of Defense (DOD) of $858,000 increased 69% as compared
to $509,000 in the fourth quarter of 2020. Full year 2021 net sales
from the VA and DOD grew 61% to approximately $3.3 million, as
compared to net sales of approximately $2.0 million for the full
year 2020.
100 VA and DoD military treatment facilities have purchased
gammaCore products through December 31, 2021, as compared to 96
facilities through September 30, 2021 and 71 facilities through the
fourth quarter of 2020.
Net sales from the Commercial channel was $271,000 in the fourth
quarter of 2021, as compared to $108,000 during the fourth quarter
of 2020. For the full year 2021, net sales in the Commercial
channel grew 89% to $679,000 as compared to $358,000 for the full
year 2020. These figures include net sales from the commercial
payer and cash pay channels in the US through our new online store,
our gConcierge, and our gCDirect programs.
Net sales from outside the United States (OUS) was $361,000 in
the fourth quarter of 2021, inclusive of all OUS channels, an
increase of 16% as compared to $311,000 in the fourth quarter of
2020. For the full year 2021, the Company reported total OUS net
sales of approximately $1.5 million, as compared to net sales of
approximately $1.1 million for the full year 2020.
Gross profit for the fourth quarter of 2021 was $1.2 million as
compared to $109,000 for the fourth quarter of 2020. Gross profit
for the fourth quarters of 2021 and 2020 included an increase in
inventory reserves of $70,000 and $434,000, respectively. Gross
margin for the full year 2021 was 76% as compared to 63% for the
full year of 2020, excluding the increase in inventory reserves in
both years.
Total operating expenses in the fourth quarter of 2021 were
approximately $6.7 million, an increase of approximately $300,000
from $6.4 million in the fourth quarter of 2020. Total operating
expenses for the fourth quarter of 2020 included a charge of
$558,000 in connection with the write-off of a right of use
operating lease asset. Total operating expenses for the full year
2021 were $24.1 million as compared to $26.5 million for the full
year 2020.
Research and development expense in the fourth quarter of 2021
was $742,000, as compared to $1.0 million for the same period in
2020. Research and development expenses for the full year 2021 were
$2.5 million as compared to $4.2 million for the full year
2020.
Selling, general and administrative expense in the fourth
quarter of 2021 was $5.9 million, as compared to $5.4 million for
the same period in 2020. Selling, general and administrative
expense for the full year 2021 was $21.6 million as compared to
$21.8 million for the full year 2020.
GAAP net loss in the fourth quarter of 2021 was $4.9 million as
compared to a GAAP net loss of $6.3 million in the fourth quarter
of 2020. GAAP net loss for the full year 2021 was $17.2 million as
compared to a GAAP net loss of $23.5 million for the full year
2020.
Adjusted EBITDA net loss in the fourth quarter of 2021 was a
loss of $4.4 million as compared to a loss of $4.3 million in the
fourth quarter of 2020. Adjusted EBITDA net loss for the full year
2021 was $15.8 million as compared to an adjusted EBITDA net loss
of $18.4 million for the full year 2020.
The company defines adjusted EBITDA net loss as GAAP net loss as
adjusted to exclude non-operating gains and losses, depreciation
and amortization, stock-compensation expense, write-off of right of
use operating lease asset, inventory reserve charges, restructuring
and other severance related charges, gain on lease settlement,
legal fees associated with stockholders’ litigation, and provision/
benefit from income taxes. 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 December 31, 2021, was
approximately $4.4 million, as compared to $3.6 million in the
fourth quarter of 2020. Net cash used in the fourth quarter of 2021
included approximately $700,000 due to the company’s refund of
overpayments it received related to the sale of NJ net operating
losses and the termination of the company’s lease for its former
corporate headquarters. Net cash used for the full year 2021 was
$13.6 million as compared to net cash used of $20.1 million
reported in 2020.
Cash and cash equivalents and marketable securities at December
31, 2021 totaled approximately $34.7 million, as compared to
approximately $22.6 million at December 31, 2020.
Webcast and Conference Call
InformationelectroCore’s management team will host a
conference call today, March 10, 2022, beginning at 4:30 PM
EST.
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:
13726544, or click here to access the webcast.
An archived webcast of the event will be available on the
“Investors” section of the company’s website at:
www.electrocore.com.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, the acute treatment of
migraine and episodic cluster headache, the acute and preventive
treatment of migraines in adolescents, and paroxysmal hemicrania
and hemicrania continua in adults.
For more information, visit www.electrocore.com.
About gammaCore™gammaCore™ (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, and paroxysmal hemicrania and
hemicrania continua 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) 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:
- Adolescent patients
with congenital cardiac issues
- 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
For more information, please visit gammaCore.com
Forward-Looking StatementsThis press release
and other written and oral statements made by representatives of
electroCore 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 business prospects and clinical and
product development plans (including with respect to enrollment in
ongoing studies); its pipeline or potential markets for its
technologies; the timing, outcome and impact of regulatory,
clinical and commercial developments including online, e-commerce,
direct-to-consumer channels, telehealth portal, and cash pay
initiatives; the issuance of U.S. and international patents
providing expanded IP coverage; the possibility of future business
models and revenue streams from the company’s potential use of nVNS
for the acute treatment of PTSD, stroke and hemorrhagic brain
injury, the potential of nVNS generally and gammaCore in particular
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™, the potential impact and effects of
COVID-19 on the business of electroCore, electroCore’s results of
operations and financial performance, and any measures electroCore
has and may take in response to COVID-19 and any expectations
electroCore may have with respect thereto, 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 CockrellCG
Capital404-736-3838ecor@cg.capital
or
Media Contact:Jackie
DorskyelectroCore908-313-6331jackie.dorsky@electrocore.com
electroCore, Inc. Consolidated Statements
of Operations(Unaudited)(in thousands, except per share
data)
|
|
Three months |
|
Year ended |
|
|
ended December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Net sales |
|
$ |
1,490.8 |
|
|
$ |
928.2 |
|
|
$ |
5,451.2 |
|
|
$ |
3,495.8 |
|
Cost of goods sold |
|
|
291.7 |
|
|
|
818.9 |
|
|
|
1,385.0 |
|
|
|
1,737.5 |
|
Gross profit |
|
|
1,199.1 |
|
|
|
109.3 |
|
|
|
4,066.2 |
|
|
|
1,758.3 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
741.8 |
|
|
|
1,018.7 |
|
|
|
2,535.9 |
|
|
|
4,201.3 |
|
Selling, general and administrative |
|
|
5,929.1 |
|
|
|
5,413.8 |
|
|
|
21,573.4 |
|
|
|
21,840.9 |
|
Restructuring and other severance related charges |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
464.6 |
|
Total operating expenses |
|
|
6,670.9 |
|
|
|
6,432.5 |
|
|
|
24,109.3 |
|
|
|
26,506.8 |
|
Loss from operations |
|
|
(5,471.8 |
) |
|
|
(6,323.2 |
) |
|
|
(20,043.1 |
) |
|
|
(24,748.5 |
) |
Other (income) expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(1,422.2 |
) |
|
|
— |
|
Gain on termination of joint venture |
|
|
(549.2 |
) |
|
|
— |
|
|
|
(549.2 |
) |
|
|
— |
|
Interest and other income |
|
|
(2.3 |
) |
|
|
(3.8 |
) |
|
|
(10.7 |
) |
|
|
(84.3 |
) |
Other expense |
|
|
1.0 |
|
|
|
4.4 |
|
|
|
8.3 |
|
|
|
17.8 |
|
Total other (income)
expense |
|
|
(550.5 |
) |
|
|
0.6 |
|
|
|
(1,973.8 |
) |
|
|
(66.5 |
) |
Loss before income taxes |
|
|
(4,921.3 |
) |
|
|
(6,323.8 |
) |
|
|
(18,069.3 |
) |
|
|
(24,682.0 |
) |
(Provision) benefit from
income taxes |
|
|
(25.5 |
) |
|
|
— |
|
|
|
851.2 |
|
|
|
1,170.9 |
|
Net loss |
|
$ |
(4,946.8 |
) |
|
$ |
(6,323.8 |
) |
|
$ |
(17,218.1 |
) |
|
$ |
(23,511.1 |
) |
Net loss per share of common
stock - Basic and Diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.60 |
) |
Weighted average number of
common shares outstanding - Basic and Diluted |
|
|
70,659,557 |
|
|
|
45,398,309 |
|
|
|
59,177,718 |
|
|
|
38,998,698 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
electroCore,
Inc. Consolidated Balance Sheet
Information(Unaudited)(in thousands)
|
|
December 31, 2021 |
|
December 31, 2020 |
Cash and cash equivalents |
|
$ |
34,688.9 |
|
|
$ |
4,241.9 |
|
Marketable securities |
|
$ |
— |
|
|
$ |
18,386.2 |
|
Total assets |
|
$ |
42,832.7 |
|
|
$ |
31,518.2 |
|
Current liabilities |
|
$ |
5,485.4 |
|
|
$ |
5,890.3 |
|
Total liabilities |
|
$ |
6,184.9 |
|
|
$ |
7,873.6 |
|
Total equity |
|
$ |
36,647.8 |
|
|
$ |
23,644.6 |
|
(Unaudited) Use of Non-GAAP Financial
MeasureThe company is presenting adjusted EBITDA net loss
because it believes this measure is a useful indicator of its
operating performance. electroCore management uses this non-GAAP
measure principally as a measure of the company’s core operating
performance and believes that this measure is useful to investors
because it is frequently used by the financial community,
investors, and other interested parties to evaluate companies in
the company’s industry. The company also believes that this measure
is useful to its management and investors as a measure of
comparative operating performance from period to period.
Additionally, the company believes its use of non-GAAP adjusted
EBITDA net loss from operations facilitates management’s internal
comparisons to historical operating results by factoring out
potential differences caused by gains and charges not related to
its regular, ongoing business, including, without limitation,
non-cash charges and certain large and unpredictable charges such
as restructuring expenses.
The company defines adjusted EBITDA net loss as GAAP net loss,
adjusting to exclude non-operating gains/losses, depreciation
and amortization, stock-compensation expense, restructuring and
other severance related charges, write-off of right of use
operating lease, inventory reserve charges, legal fees associated
with stockholders’ litigation, and provision / benefit from income
taxes. 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.
|
|
Three months ended |
|
Year ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
(in thousands) |
|
(in thousands) |
GAAP net loss |
|
$ |
(4,946.8 |
) |
|
$ |
(6,323.8 |
) |
|
$ |
(17,218.1 |
) |
|
$ |
(23,511.1 |
) |
Depreciation and
amortization |
|
|
95.1 |
|
|
|
110.6 |
|
|
|
381.5 |
|
|
|
399.2 |
|
Stock-based compensation |
|
|
761.5 |
|
|
|
775.7 |
|
|
|
3,302.1 |
|
|
|
3,266.3 |
|
Write-off of right of use
operating lease |
|
|
— |
|
|
|
557.5 |
|
|
|
— |
|
|
|
557.5 |
|
Inventory reserve charge |
|
|
70.0 |
|
|
|
434.0 |
|
|
|
70.0 |
|
|
|
434.0 |
|
Restructuring and other
severance related charges |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
464.6 |
|
Gain on extinguishment of
debt |
|
|
— |
|
|
|
— |
|
|
|
(1,422.2 |
) |
|
|
— |
|
Gain on termination of joint
venture |
|
|
(549.2 |
) |
|
|
— |
|
|
|
(549.2 |
) |
|
|
— |
|
Gain on lease settlement |
|
|
(57.4 |
) |
|
|
— |
|
|
|
(57.4 |
) |
|
|
— |
|
Legal fees associated with
stockholders litigation |
|
|
186.8 |
|
|
|
135.5 |
|
|
|
581.6 |
|
|
|
1,205.3 |
|
Interest and other income |
|
|
(1.3 |
) |
|
|
0.6 |
|
|
|
(2.4 |
) |
|
|
(66.5 |
) |
Provision (Benefit) from
income taxes |
|
|
25.5 |
|
|
|
— |
|
|
|
(851.2 |
) |
|
|
(1,170.9 |
) |
Adjusted EBITDA net
loss |
|
$ |
(4,415.8 |
) |
|
$ |
(4,309.9 |
) |
|
$ |
(15,765.3 |
) |
|
$ |
(18,421.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The company’s use of a non-GAAP measure has limitations as an
analytical tool, and you should not consider it in isolation or as
a substitute for analysis of its results as reported under GAAP.
Some of these limitations are: the non-GAAP measure does not
reflect interest or tax payments that may represent a reduction in
cash available; although depreciation and amortization are non-cash
charges, the assets being depreciated and amortized may have to be
replaced in the future, and the non-GAAP measure does not reflect
cash capital expenditure requirements for such replacements or for
new capital expenditure requirements; the non-GAAP measure does not
reflect the potentially dilutive impact of equity-based
compensation; and the non-GAAP measure does not reflect changes in,
or cash requirements for, working capital needs; other companies,
including companies in electroCore’s industry, may calculate
adjusted EBITDA net loss differently, which reduces its usefulness
as a comparative measure.
Because of these and other limitations, you should consider the
non-GAAP measure together with other GAAP-based financial
performance measures, including various cash flow metrics, net
loss, and other GAAP results. A reconciliation of GAAP net loss to
non-GAAP adjusted EBITDA net loss has been provided in the
preceding financial statements table of this press
release.
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