AeroClean Technologies (“AeroClean” or the “Company”) (Nasdaq:
AERC), a leading pathogen elimination technology company, today
reported financial results for the three and six months ended June
30, 2022 (“Q2 2022”). All financial information is presented in
U.S. dollars unless otherwise indicated.
Second Quarter 2022
Highlights
- Granted U.S. Food and Drug
Administration (“FDA”) 510(k) clearance for Pūrgo™ medical grade
air hygiene technology intended for medical use and the elimination
of harmful airborne microorganisms.
- Completed $15.0 million private
placement in June 2022, positioning the company to evaluate a wide
range of strategic opportunities including acquisitions.
- Jimmy Thompson, healthcare
technology expert, appointed as Vice President of Strategic Sales
in June 2022.
- Timothy Scannell, former President
and Chief Operating Officer of Stryker, appointed to Board of
Directors in May 2022.
- Signed letter of intent to acquire
GSI Technology (“GSI”), focused on deploying an analytics-based
approach to indoor air quality (“IAQ”) by monitoring real-time air
quality and work safety conditions in an innovative, integrated
dashboard offering air quality, human capital and security. GSI
also focuses on public procurement opportunities to utilize the
billions of dollars of funding committed by the government to
address COVID preparedness as well as enhancing ventilation and
IAQ. The Company makes no assurance that the transaction with GSI
will be consummated.
- Participated in numerous industry
conferences and tradeshows, including for the Association for
Professionals in Infection Control and Epidemiology, ASHRAE,
American Society for Healthcare Engineering, and National
Facilities Management and Technology, further growing a distributor
base in target markets.
Recent Developments
- Independent laboratory testing has
proven that the Company’s Pūrgo™ air purifier is effective at
reducing 99.99% of indoor viral concentrations of the Omicron
variant of SARS-CoV-2, the virus that causes COVID-19, which the
CDC identifies as the current dominant variant in the United
States.
- Preparations continue for the
launch of Pūrgo Lift, the unique, mission-critical application of
our patented and proprietary technology engineered for elevators
and other wall/ceiling-mounted applications, targeted for the
fourth quarter of 2022.
- Joe Lesters, with a proven track
record in building and deploying healthcare technology software,
systems, and databases, hired as Chief Technology Officer in July
2022.
- Announced partnership with the
Florida chapter of the Club Management Association of America
(FLCMAA), securing multiple deployments of safe air technology at
notable hospitality and club spaces, as official health and safety
sponsor for the organization.
- Launched new Investor Relations
website to enhance communications with investors, analysts, media
and other stakeholders, offering intuitive access to essential
information.
Management Commentary
“In the second quarter, we were pleased to
receive FDA 510(k) clearance for our Pūrgo™ device, and I again
thank the administration for their thorough review of our patented
air hygiene technology,” said Jason DiBona, Chief Executive Officer
of AeroClean. “Our Pūrgo™ system, which is powered by our patented
SteriDuct™ technology, has been rigorously tested in a wide variety
of laboratory and real-world indoor spaces. The designation of our
Pūrgo™ technology as a Class II Medical Device represents a major
milestone for our business, and further differentiates us from
competitors in both performance and efficacy. In fact, we are
already seeing increased interest from new potential clients as a
result of this development.”
“Following the receipt of FDA clearance, in
order to accelerate our go-to-market strategy we were proud to
announce the addition of Jimmy Thompson as Vice President of
Strategic Sales in June,” said Mr. DiBona. “In this new role, Jimmy
is utilizing his deep experience in the healthcare industry to
build and grow our sales teams and develop market channels that
strengthen the AeroClean brand and drive revenue growth. We believe
our investments in talent and scientifically-proven technology,
evidenced by our recent testing on Pūrgo’s effectiveness at
eliminating the Omicron variant of SARS-CoV-2 in real-world
scenarios, will continue to differentiate us from the
competition.”
“In addition to our focus on organic growth, the
completion of the $15.0 million private placement at the end of
June supports the Company’s strategy to continuously evaluate a
wide range of strategic opportunities including acquisitions. As
part of that strategy, the Company is in discussions with several
acquisition candidates and may use the proceeds, together with
other sources of capital, to effect transactions that the Company
believes would substantially increase revenues, distribution and
selling capability, and expand product lines, and, most
importantly, add sensor and monitoring technology to enable the
Company to effect its recurring revenue “Safe Air-as-a-Service”
model. The Company’s goal is to provide actionable data to clients
through the internet of things (IOT) to enable clients to provide
Indoor Air Quality (IAQ) as part of their Indoor Environmental
Quality (IEQ) initiatives.” The Company makes no assurance that
these acquisitions, or any others, will be consummated.
Mr. DiBona continued, “We are well-positioned
with sufficient operating liquidity to complete the development,
testing and expected launch of Pūrgo Lift in Q4 of 2022. Elevators
are a confined space that people are still reluctant to share with
others and remain an acute point of vulnerability. We believe Pūrgo
Lift is a break-through technology to assist companies and
hospitals with safe ‘return-to-work’ initiatives as many employees,
customers and patients are still reluctant to fully re-immerse
themselves in society.
“During the second quarter, we were able to
overcome some of the negative impacts caused by the global supply
chain issues that peaked earlier this year,” Mr. DiBona continued.
“We continue to identify and implement further improvements to our
own manufacturing processes, with a particular focus on pre-empting
any future electronic component bottlenecks to create lasting
strength as our business expands. After the brief pause in
production during the first quarter and the FDA 510(k) clearance in
the second quarter, we are pleased to report that our sales team
has been diligently engaged in numerous discussions for direct
sales and distribution opportunities, sales began to rebound from
the first quarter pause, and we see positive momentum continuing
into the third quarter.”
“Last month, we were proud to announce new
partnerships with several organizations including as the official
Health & Safety Sponsor of the Florida Chapter of the Club
Management Association of America (“FLCMAA”),” DiBona added. “The
largest chapter worldwide, FLCMAA has more than 700 members
representing more than 300 country, golf, city and yacht clubs. We
have enjoyed early success in this channel, and we expect our
relationships within this target market to continue to grow over
time, expanding into new sales opportunities in Florida and beyond.
Meanwhile, we remain focused on securing and developing
distribution and channel partner relationships for hospitals,
non-hospital/ambulatory/surgery center markets, and both public and
private commercial sectors, and we are in active discussions within
each of these target markets. We look forward to sharing our
continued progress during the rest of 2022, as we expect our sales
teams to ramp up steadily through the end of the year.”
Q2 2022 Financial Overview
Revenues for the second quarter of 2022 were
$70,918, a $64,185 increase as compared to $6,733 during the first
quarter of 2022. The Company did not report revenues in the second
quarter of fiscal year 2021. Gross profit of $34,792, or 49.1% of
revenues, increased by $31,823 as compared to gross profit of
$2,969 in the first quarter of 2022.
Selling, general and administrative (“SG&A”)
expenses, including offering costs of $1,326,212, for the second
quarter of 2022 were $4,105,066 compared to $2,142,224 in the first
quarter of 2022. In the second quarter of 2022, SG&A was
$2,778,854, excluding offering costs.
Research and development expenses for the second
quarter of 2022 were relatively flat at $579,061 compared to
$531,483 in the first quarter of 2022. Research and development
expenses primarily consisted of quality and regulatory, testing,
engineering, and manufacturing design costs.
Net loss for the second quarter of 2022 was
$5,172,277, or $0.37 per share, compared to a net loss of
$2,577,964, or $0.19 per share, in the first quarter of 2022. The
Company also incurred a non-cash loss of $650,000 related to the
change in fair value of the warrants issued in connection with the
private placement. Excluding the offering costs of $1,326,212 and
non-cash loss of $650,000, net loss for the second quarter of 2022
was $3,196,065.
Cash was $29,163,429 as of June 30, 2022,
compared to $17,774,097 as of March 31, 2022, and total current
assets were $30,724,789 and total current liabilities were
$1,776,165 as of June 30, 2022. Net working capital (current assets
less current liabilities) as of June 30, 2022 was $28,948,624, and
the Company has no debt.
Financial results and analyses are available on
the Company’s investor relations website:
https://investors.aeroclean.com/.
Forward-Looking Statements
This press release includes forward-looking
statements relating to our management’s expectations, beliefs and
intentions and AeroClean’s prospects. Forward-looking statements
are statements that are not historical facts, including the
statements of our management and statements under the heading
“Management Commentary.” Such forward-looking statements are based
on our management’s current expectations and projections about
future events and trends, which are inherently subject to risks,
assumptions and uncertainties that could cause actual results to
differ materially from those explicitly or implicitly projected,
including (without limitation): macroeconomic uncertainties driven
by the war between Ukraine and Russia; rising inflation and the
COVID-19 pandemic; a failure by our products to perform as
expected; our inability to develop adequate distribution, customer
service, and technical support networks; our failure to implement
our business strategy; the effects of any acquisitions of other
companies or technologies, including the possible diversion of the
attention of our management or any challenges faced while
integrating such into our business; any delay in or failure to
achieve clearance from the U.S. Food and Drug Administration to
market our products or our failure to comply with applicable laws
and regulations; our inability to develop and maintain reliable
manufacturing, consulting and other vendor relationships important
to the commercialization of our products; our inability to protect
our intellectual property or our infringement upon the proprietary
rights of others; our inability to efficiently manage research and
development spending; potential dilution of existing stockholders
if we issue additional equity securities (including in connection
with acquisitions); and risks related to maintaining our listing on
Nasdaq.
These and other risks and uncertainties that
could affect AeroClean’s future results are included under the
caption “Risk Factors” in AeroClean’s annual report on Form 10-K
for the fiscal year ended December 31, 2021 and our quarterly
report on Form 10-Q for the fiscal quarter ended March 31, 2022
filed with the Securities and Exchange Commission (“SEC”) on April
1, 2022 and May 12, 2022, respectively, which are available on the
SEC’s website at www.sec.gov. Further information regarding
potential risks or uncertainties that could affect actual results
will be included in other periodic filings AeroClean makes with the
SEC.
The forward-looking statements in this release
reflect management’s expectations as of the date hereof and
AeroClean expressly disclaims any obligations or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in the
expectations with respect thereto or any change in events,
conditions or circumstances on which any statement is based.
Investors should realize that if our underlying assumptions for the
expectations contained herein prove inaccurate or that known or
unknown risks or uncertainties materialize, actual results could
vary materially from our expectations.
About AeroClean
Technologies
AeroClean is a pathogen elimination technology
company on a mission to keep work, play and life going—with
continuous air sanitization products called Pūrgo™ (pure-go). We
create solutions for hospitals, offices and many shared spaces as
well as elevators and more. Pūrgo™ products feature SteriDuct™, a
proprietary technology developed by our best-in-class aerospace
engineers, medical scientists and innovators. Powered by
SteriDuct™, our solutions are medical grade, eradicating viral,
fungal and bacterial airborne pathogens. Our purpose is simple: to
never stop innovating solutions that keep people healthy and safe,
so life never stops. Learn more at aeroclean.com.
Media ContactDrew Tybusdrew@oakpr.com
Investor Relations ContactsRyan TylerChief
Financial Officer, AeroCleanRTyler@AeroClean.com
Brian PinkstonMATTIO Communicationsaeroclean@mattio.com
Financial Statements
AEROCLEAN TECHNOLOGIES,
INC.Balance Sheets
|
June 30, 2022 |
|
December 31, 2021 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
|
|
|
Cash |
$ |
29,163,429 |
|
$ |
19,629,649 |
Other current assets |
1,561,360 |
|
1,948,004 |
Total current assets |
30,724,789 |
|
21,577,653 |
Non-current assets |
2,227,120 |
|
2,145,095 |
Total assets |
$ |
32,951,909 |
|
$ |
23,722,748 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities |
$ |
1,776,165 |
|
$ |
1,511,079 |
Non-current liabilities |
14,926,422 |
|
501,254 |
Total liabilities |
16,702,587 |
|
2,012,333 |
Total equity |
16,249,322 |
|
21,710,415 |
Total liabilities and
stockholders' equity |
$ |
32,951,909 |
|
$ |
23,722,748 |
AEROCLEAN TECHNOLOGIES,
INC.Statements of Operations
(Unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
$ |
70,918 |
|
|
$ |
- |
|
|
$ |
77,652 |
|
|
$ |
- |
|
Cost of sales |
36,126 |
|
|
- |
|
|
39,891 |
|
|
- |
|
Gross profit |
34,792 |
|
|
- |
|
|
37,761 |
|
|
- |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
4,105,066 |
|
|
1,613,608 |
|
|
6,247,290 |
|
|
1,993,610 |
|
Research and development |
579,061 |
|
|
1,070,912 |
|
|
1,110,544 |
|
|
2,660,602 |
|
Total operating expenses |
4,684,127 |
|
|
2,684,520 |
|
|
7,357,834 |
|
|
4,654,212 |
|
Loss from operations |
(4,649,335 |
) |
|
(2,684,520 |
) |
|
(7,320,073 |
) |
|
(4,654,212 |
) |
Change in fair value of
warrant liability |
650,000 |
|
|
- |
|
|
650,000 |
|
|
- |
|
Loss before income tax
benefit |
(5,299,335 |
) |
|
(2,684,520 |
) |
|
(7,970,073 |
) |
|
(4,654,212 |
) |
Income tax benefit |
(127,058 |
) |
|
- |
|
|
(219,832 |
) |
|
- |
|
Net loss |
$ |
(5,172,277 |
) |
|
$ |
(2,684,520 |
) |
|
$ |
(7,750,241 |
) |
|
$ |
(4,654,212 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.37 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.56 |
) |
|
$ |
(0.49 |
) |
Weighted-average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
13,894,119 |
|
|
11,361,025 |
|
|
13,885,923 |
|
|
9,491,797 |
|
AEROCLEAN TECHNOLOGIES,
INC.Statements of Cash Flows
(Unaudited)
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
Net cash flows used in operating
activities |
(4,312,706 |
) |
|
(3,950,684 |
) |
Net cash flows used in investing
activities |
(154,065 |
) |
|
(1,785,517 |
) |
Net cash flows provided by
financing activities |
14,000,551 |
|
|
5,173,599 |
|
Net increase in
cash |
9,533,780 |
|
|
(562,602 |
) |
Cash, beginning of
period |
19,629,649 |
|
|
2,333,117 |
|
Cash, end of period |
$ |
29,163,429 |
|
|
$ |
1,770,515 |
|
|
|
|
|
|
|
Supplemental schedule of
non-cash activities: |
|
|
|
|
|
Purchases of property and equipment in accounts payable |
$ |
- |
|
|
$ |
46,716 |
|
Offering costs in private placement |
$ |
422,000 |
|
|
$ |
- |
|
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