electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, announced second quarter 2021
financial results and provided an operational update.
Second Quarter 2021 and Recent
Highlights
- Posted revenue of $1.3 million, representing an increase of 5%
sequentially and 69% over second quarter of 2020
- Net cash used was $3.2 million during the second quarter of
2021 leaving approximately $23.7 million of cash, cash equivalents,
and marketable securities at June 30, 2021
- A follow-on public offering subsequent to June 30, 2021 added
approximately $18.8 million of net proceeds
Dan Goldberger, Chief Executive Officer of electroCore,
commented: “We are pleased that our second quarter results were in
line with expectations, representing revenue growth of 69%
year-over-year and 5% over first quarter of 2021. We saw continued
progress in operating metrics across all our revenue channels. Our
cash balance of $23.7 million at June 30, 2021, together with the
approximately $18.8 million raised in our subsequent public
offering and lower operating burn, puts the company in an excellent
position to execute on its plan through 2022.”
Second Quarter 2021 Financial Results For
the quarter ended June 30, 2021, electroCore reported net sales of
$1,300,000 compared to $1,200,000 in the first quarter of 2021 and
$753,000 during same period of 2020. This represents a quarterly
revenue increase of 5% sequentially and 69% over the same period
last year.
Revenue from the Department of Veterans Affairs (“VA”) and
Department of Defense (“DOD”) increased 15% sequentially to
$779,000 in the second quarter of 2021 from $679,000 in the first
quarter of 2021 and increased 88% as compared to $415,000 in the
second quarter of 2020.85 VA and DoD military treatment facilities
have purchased gammaCore products through June 30, 2021 as compared
to 79 through the first quarter of 2021 and 67 through the second
quarter of 2020.
Revenue from outside the United States through direct sales
channels increased sequentially by 10% to $369,000 in the second
quarter of 2021, as compared to $335,000 during the first quarter
of 2021 and increased 50% from $247,000 during the second quarter
of 2020. These figures do not include new stocking distributors in
other countries which contributed $18,000 of revenue from Canada
and Western Europe during the second quarter of 2021.
Gross profit for the second quarter of 2021 was $895,000 as
compared to $840,000, for the first quarter of 2021 and $480,000
for the second quarter of 2020. Gross margin for the second
quarter of 2021 was 71%, compared to 70% in the first quarter of
2021 and 64% in the second quarter of 2020.
Total operating expenses in the second quarter of 2021 were
approximately $6,100,000, a reduction of approximately $100,000
from $6,200,000 in the first quarter of 2021 and a reduction of
$300,000 from $6,400,000 in the second quarter of 2020.Research and
development expense in the second quarter of 2021 was $825,000, as
compared to $500,000 in the first quarter of 2021, an increase of
approximately $325,000 sequentially. Research and development
expense decreased by $175,000 from $1,000,000 during the second
quarter of 2020.
Selling, general and administrative expense in the second
quarter of 2021 were $5,300,000 as compared to $5,700,000 in the
first quarter of 2021. Selling, general and administrative expense
was flat as compared to the second quarter of 2020.
GAAP net loss in the second quarter of 2021 was $2,900,000
compared to a GAAP net loss of $5,400,000 in the first quarter of
2021. GAAP net loss decreased by 39% or $1,800,000 as compared to a
GAAP net loss of $4,700,000 in the second quarter of 2020.
Adjusted EBITDA net loss in the second quarter of 2021 was
$4,100,000 as compared to $4,200,000 during the first quarter of
2021 and as compared to adjusted EBITDA net loss of $4,300,000 in
the second 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, total other
income/expense, extinguishment of debt, and 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 June 30, 2021, exclusive of
cash proceeds from the sale of NJ NOL carryforwards, was
approximately $3,200,000, as compared to $4,100,000 in the first
quarter of 2021, and $5,200,000 in the second quarter of 2020.
Cash, cash equivalents and marketable securities at June 30,
2021, totaled approximately $23,700,000, as compared to
approximately $25,500,000 at March 31, 2021. Subsequent to June 30,
2021, the company raised net proceeds of approximately $18,800,000
through a public offering of 20,700,000 shares of its common
stock.
Third Quarter 2021 OutlookFor the third quarter
of 2021, the Company expects net revenue to be at least $1,500,000
and net cash usage, exclusive of financing activities, to be
approximately $4,500,000. The expected increase in net cash
usage is largely due to the annual renewal of our insurance
policies.
Webcast and Conference Call
InformationelectroCore’s management team will host a
conference call today, August 5, 2021, beginning at 4:30pm ET.
Investors interested in listening to the conference call, or
webcast may do so by dialing 888-506-0062 for domestic callers or
973-528-0011 for international callers, using Conference ID:
748491, or by connecting to the Web: electroCore 2Q21 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.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.
About
gammaCoreTMgammaCoreTM (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. 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:
- 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
Please refer to the gammaCore Instructions for Use for all of
the important warnings and precautions before using or prescribing
this product.
The 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.
gammaCore 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 revoked.
More information can be found at:Letter of authorization:
https://www.fda.gov/media/139967/downloadFact sheet for healthcare
workers: https://www.fda.gov/media/139968/downloadPatient
information sheet:
https://www.fda.gov/media/139969/downloadInstructions for use of
gammaCore: https://www.fda.gov/media/139970/download
Forward-Looking StatementsThis 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 third quarter of 2021, its
expectations for future performance, as well as electroCore's
business prospects and clinical and product development plans for
2021 and beyond, its pipeline or potential markets for its
technologies, additional indications for gammaCore, the timing,
outcome and impact of regulatory, clinical and commercial
developments (including human trials for the study of headache,
PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and
the business, operating or financial impact of such studies),
further international expansion, and statements about anticipated
distribution arrangements, government and payor funding
arrangements (including those relating to Canada, Western Europe,
Qatar, Taiwan, and China) 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 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.
electroCore,
Inc.Condensed Consolidated Statements of
Operations(Unaudited)(in thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
months |
|
Six
months |
ended June 30, |
|
ended June 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Net
sales |
|
$ |
1,269.5 |
|
|
$ |
753.0 |
|
|
$ |
2,473.4 |
|
|
$ |
1,486.7 |
|
Cost of
goods sold |
|
|
374.3 |
|
|
|
273.0 |
|
|
|
738.3 |
|
|
|
571.1 |
|
Gross profit |
|
|
895.2 |
|
|
|
480.0 |
|
|
|
1,735.1 |
|
|
|
915.6 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
824.9 |
|
|
|
1,030.5 |
|
|
|
1,323.9 |
|
|
|
2,553.6 |
|
Selling, general and administrative |
|
|
5,272.9 |
|
|
|
5,273.3 |
|
|
|
10,997.5 |
|
|
|
11,834.1 |
|
Restructuring and other severance related
charges |
|
|
- |
|
|
99.6 |
|
|
|
- |
|
|
464.6 |
|
Total operating
expenses |
|
|
6,097.8 |
|
|
|
6,403.4 |
|
|
|
12,321.4 |
|
|
|
14,852.3 |
|
Loss from operations |
|
|
(5,202.6 |
) |
|
|
(5,923.4 |
) |
|
|
(10,586.3 |
) |
|
|
(13,936.7 |
) |
Other
(income) expense |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
|
|
(1,422.2 |
) |
|
|
- |
|
|
(1,422.2 |
) |
|
|
- |
Interest and other income |
|
|
(1.3 |
) |
|
|
(11.7 |
) |
|
|
(1.1 |
) |
|
|
(74.7 |
) |
Other expense |
|
|
- |
|
|
0.7 |
|
|
|
- |
|
|
9.8 |
|
Total other
(income) expense |
|
|
(1,423.5 |
) |
|
|
(11.0 |
) |
|
|
(1,423.3 |
) |
|
|
(64.9 |
) |
Loss before
income taxes |
|
|
(3,779.1 |
) |
|
|
(5,912.4 |
) |
|
|
(9,163.0 |
) |
|
|
(13,871.8 |
) |
Benefit from
income taxes |
|
|
885.4 |
|
|
|
1,170.9 |
|
|
|
885.4 |
|
|
|
1,170.9 |
|
Net
loss |
|
$ |
(2,893.7 |
) |
|
$ |
(4,741.5 |
) |
|
$ |
(8,277.6 |
) |
|
$ |
(12,700.9 |
) |
Net loss per
share of common stock - Basic and Diluted |
|
$ |
(0.06 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.38 |
) |
Weighted average number of common shares outstanding - Basic and
Diluted |
48,520,241 |
|
|
|
36,658,797 |
|
|
|
48,089,117 |
|
|
|
33,216,512 |
|
electroCore,
Inc.Condensed Consolidated Balance Sheet
Information(Unaudited)(in thousands)
|
|
June 30, 2021 |
|
December 31, 2020 |
Cash and
cash equivalents |
|
|
$ |
14,699.1 |
|
|
|
$ |
4,241.9 |
Marketable
securities |
|
|
$ |
9,027.8 |
|
|
|
$ |
18,386.2 |
Total
assets |
|
|
$ |
31,297.2 |
|
|
|
$ |
31,518.2 |
Current
liabilities |
|
|
$ |
5,757.5 |
|
|
|
$ |
5,890.3 |
Total
liabilities |
|
|
$ |
6,680.7 |
|
|
|
$ |
7,873.6 |
Total
equity |
|
|
$ |
24,616.5 |
|
|
|
$ |
23,644.6 |
(Unaudited) Use of Non-GAAP Financial
Measure
The 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 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,
excluding depreciation and amortization, stock-compensation
expense, restructuring and other severance related charges, legal
fees associated with stockholders’ litigation, total other
income/expense, extinguishment of debt, and 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 |
|
Six months
ended |
|
|
|
|
|
|
June 30, |
|
June 30, |
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
(in
thousands) |
|
(in
thousands) |
|
|
|
|
GAAP
net loss |
|
$ |
(2,893.7 |
) |
|
|
$ |
(4,741.5 |
) |
|
$ |
(8,277.6 |
) |
|
|
$ |
(12,700.9 |
) |
|
|
|
|
Depreciation
and amortization |
|
|
95.6 |
|
|
|
|
96.3 |
|
|
|
191.3 |
|
|
|
|
193.7 |
|
|
|
|
|
Stock-based
compensation |
|
|
838.0 |
|
|
|
|
1,002.7 |
|
|
|
1,780.2 |
|
|
|
|
1,747.6 |
|
|
|
|
|
Restructuring and other severance related charges |
- |
|
|
|
99.6 |
|
|
|
- |
|
|
|
464.6 |
|
|
|
|
|
Legal fees associated with stockholders litigation |
166.0 |
|
|
|
|
402.0 |
|
|
|
317.4 |
|
|
|
|
729.0 |
|
|
|
|
|
Interest and
other (income) expense |
|
|
(1.3 |
) |
|
|
|
(11.0 |
) |
|
|
(1.1 |
) |
|
|
|
(64.9 |
) |
|
|
|
|
Benefit from
income taxes |
|
|
(885.4 |
) |
|
|
|
(1,170.9 |
) |
|
|
(885.4 |
) |
|
|
|
(1,170.9 |
) |
|
|
|
|
Gain on
extinguishment of debt |
|
|
(1,422.2 |
) |
|
|
|
- |
|
|
(1,422.2 |
) |
|
|
|
- |
|
|
|
|
Adjusted EBITDA net loss |
|
$ |
(4,103.0 |
) |
|
|
$ |
(4,322.8 |
) |
|
$ |
(8,297.4 |
) |
|
|
$ |
(10,801.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com
electroCore (NASDAQ:ECOR)
Gráfico Histórico do Ativo
De Jun 2024 até Jul 2024
electroCore (NASDAQ:ECOR)
Gráfico Histórico do Ativo
De Jul 2023 até Jul 2024