MOLEKULE GROUP, INC. The following discussion and analysis should be read in conjunction with the historical condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q (this "Quarterly Report") as well as our audited financial statements for the fiscal year endedDecember 31, 2021 included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , filed with theSecurities and Exchange Commission (the "SEC") onApril 1, 2022 (our "Annual Report"). This discussion contains forward-looking statements reflecting our current expectations and estimates and assumptions concerning events and financial trends that may affect our future operating results or financial position. See "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" appearing elsewhere in this Quarterly Report. You should review the "Risk Factors" section of our Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
AeroClean Technologies is an interior space air purification technology company. Our immediate objective is to initiate full-scale commercialization of our high-performance interior air sterilization and disinfection products for the eradication of harmful airborne pathogens, including COVID-19. We were established to develop unmatched, technology-driven medical-grade air purification solutions for hospitals and other healthcare settings. The onset of the COVID-19 global pandemic underscores the urgency of bringing to market air purification solutions to protect front-line healthcare workers, patients and the general population.
We incorporate our proprietary, patented UV-C LED technology in equipment and devices to reduce the exposure of occupants of interior spaces to airborne particles and pathogens. These spaces include hospital and non-hospital healthcare facilities (such as outpatient chemotherapy and other infusion facilities and senior living centers and nursing homes), schools and universities, commercial properties and other indoor spaces.
InJuly 2021 , we completed the development stage of our first device, the P?rgo room air purification unit, including design and independent testing and certification, as well as the scale-up of manufacturing, and began commercial production and sales. P?rgo's launch also marks the debut of our go-to-market strategy for SteriDuct, our patented air purification technology. We intend to incorporate SteriDuct into a broad line of autonomous air treatment devices. InFebruary 2022 , we debuted a prototype of P?rgo Lift, our air purification solution for elevators and other wall-mount applications, and since then, certain of our customers have been testing and evaluating P?rgo Lift for future deployment in their facilities. To support the transition to commercial operations, inJuly 2021 , we also completed the build out of our corporate headquarters inPalm Beach Gardens, Florida , which includes our warehouse and distribution facility, as well as the site for our future service operations. Our products are being designed and engineered to exceed the rigorous standards set by theU.S. Food and Drug Administration (the "FDA") for Class II medical devices used for interior air sterilization and disinfection products. InJune 2022 , the FDA granted our P?rgo technology 510(k) clearance for use in healthcare and other markets for which product performance to reduce the amount of certain airborne particles and infectious microbes in an indoor environment must be validated to specific standards. Our P?rgo technology was tested and certified to meet such standards by independent laboratories. Regulatory clearances and independent certifications serve as important indications of product quality and performance that also influence decision-making by non-healthcare market equipment purchasers.
P?rgo has been well-received by our customers. Our success depends to a large extent on our ability to increase sales of our P?rgo device during 2022 and beyond.
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We have incurred operating losses each year since our inception and have only
begun to recognize revenue starting in July 2021 . We incurred losses of
approximately $7.8 million , $7.9 million and $3.3 million during the six months
ended June 30, 2022 and the years ended December 31, 2021 and 2020,
respectively, and had an accumulated deficit of approximately $9.5 million as of
June 30, 2022 . As of June 30, 2022 , the Company had aggregate cash balance of
approximately $29.2 million . As part of our business strategy we continually
evaluate a wide array of strategic opportunities, including the acquisition,
disposition or licensing of intellectual property, mergers and acquisitions,
joint ventures and other strategic transactions. In connection with these
activities we may enter into non-binding letters of intent as we assess the
commercial appeal of potential strategic transactions. We may seek to acquire
technologies, product lines and companies that operate in businesses similar to
our own or that are ancillary, complementary or adjacent to our own or in which
we do not currently operate. Such businesses could operate in the air
purification space or more generally in the health and wellness space or in
other industries. We could also seek to merge with or into another company or
sell all or substantially all of our assets to another company. Any transactions
that we enter into could be material to our business, financial condition and
operating results.
As part of this strategy, the Company has been in discussions with several
acquisition candidates and may seek 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 currently has no material agreements or arrangements
with any of the several acquisition candidates and there can be no assurance
that any of these acquisitions, or any others, will be consummated.
Please see related risks described under the captions "We may acquire other
companies or technologies, which could divert our management's attention, result
in additional dilution to stockholders and otherwise disrupt our operations, and
adversely affect our business, financial condition and results of operations"
and "Our executive officers, directors and principal stockholders have the
ability to control all matters submitted to stockholders for approval" in the
"Risk Factors" section of our Annual Report on Form 10-K filed with the SEC onApril 1, 2022 . COVID-19 Pandemic We continue to monitor the COVID-19 pandemic and its variants, including the emergence of variant strains, which continue to spread throughout the world and have adversely impacted global commercial activity and contributed to significant declines and volatility in financial markets. Across many industries, including our own, COVID-19 - among other factors - has negatively impacted personnel and operations at third-party manufacturing and component part supplier facilities inthe United States and around the word. These disruptions have adversely impacted the availability and cost of raw materials and component parts. For example, various electronic components and semi-conductor chips have become increasingly difficult to source, and when available, may be subject to substantially longer lead times and higher costs than historically applicable. While the Company's manufacturing run rate is not currently being impacted, past shortages have impacted the Company's ability to manufacture units and likely the run rates the Company expects to achieve for the remainder of this fiscal year. The Company does have line of sight to improvement on some long lead-time board and electronics components in the second half of 2022 but cannot predict the ever-changing global logistics and supply chain environment. We continue to actively monitor the situation and may take further actions that impact operations as may be required by federal, state or local authorities or that we determine is in the best interests of our employees, customers, suppliers and stockholders. As of the date of this Quarterly Report, the pandemic presents uncertainty and risk as we cannot reasonably determine or predict the nature, duration or scope of the overall impact the COVID-19 pandemic and the evolving strains of COVID-19 will have on our business, results of operations, liquidity or capital resources. 17 Table of Contents Results of Operations
The following table summarizes our results of operations for the periods indicated:
Comparison of the Six Months and Three Months ended
Three Months Ended June 30, Six Months Ended June 30,
2022 2021 Change 2022 2021 Change
Product revenues $ 70,918 $ - $ 70,918 $ 77,652 $ - $ 77,652
Cost of sales 36,126 - 36,126 39,891 - 39,891
Gross profit 34,792 - 34,792 37,761 - 37,761
Operating expenses:
Selling, general and
administrative 4,105,066 1,613,608 2,491,458 6,247,290 1,993,610 4,253,680 Research and development
579,061 1,070,912 (491,851) 1,110,544 2,660,602 (1,550,058) Total operating expenses
4,684,127 2,684,520 1,999,607 7,357,834 4,654,212 2,703,622 Loss from operations
(4,649,335) (2,684,520) (1,964,815) (7,320,073) (4,654,212) (2,665,861) Change in fair value of warrant liability
650,000 - 650,000 650,000 - 650,000
Loss before income tax benefit (5,299,335) (2,684,520) (2,614,815) (7,970,073) (4,654,212) (3,315,861)
Income tax benefit (127,058) - (127,058) (219,832) - (219,832)
Net loss $ (5,172,277) $ (2,684,520) $ (2,487,757) $ (7,750,241) $ (4,654,212) $ (3,096,029)
Revenues and Cost of Sales
The Company began the production and sale of its first commercial product, P?rgo, inJuly 2021 , and therefore, did not have any revenue in the prior year period. Revenues for the three and six months endedJune 30, 2022 were$70,918 and$77,652 , respectively. Sales increased for the quarter endedJune 30, 2022 as the Company resumed production after pausing production while testing was being conducted in the quarter endedMarch 31, 2022 , and the Company began to distribute its product within a number of new target segments including hospitality and leisure and commercial office space. Cost of sales increased in line with the increase in revenues as compared to the prior year period. 18 Table of Contents Operating Expenses
Selling, General and Administrative Expenses
Selling, general and administrative expenses ("SG&A") consist primarily of costs
related to our employees, independent contractors and consultants. Other
significant general and administrative expenses include accounting and legal
services and expenses associated with obtaining and maintaining patents as well
as marketing and advertising services and expenses associated with establishing
our brand and developing our website, marketing materials and call center.
For the three months ended June 30, 2022 and 2021, we incurred $4,105,066 and
$1,613,608 , respectively, of SG&A expenses. We attribute the increase of
$2,491,458 primarily to offering costs expensed in conjunction with the private
placement (approximately $1,300,000 ) public company costs (an increase of
approximately $1,000,000 ) and costs related to the development of P?rgo Lift (an
increase of approximately $150,000 ).
For the six months ended June 30, 2022 and 2021, we incurred $6,247,290 and
$1,993,610 , respectively, of SG&A expenses. We attribute the increase of
$4,253,680 primarily to the offering costs associated with the private placement
(approximately $1,300,000 ) and an increase in costs required to be a public
company as well as a greater level of business activities being conducted in the
six months ended June 30, 2022 as compared to the same period in 2021. Public
company costs include: audit and legal fees; costs required to establish
investor relations, financial reporting and public relations functions;
increased insurance costs; public company filing and registration fees; and
related costs. These public company costs drove an increase in SG&A of
approximately $1,800,000 for the six months ended June 30, 2022 as compared to
the prior year period. The balance of the increase was primarily due to an
increase in stock-based compensation expense of approximately $500,000 and
increased rent and personnel costs of approximately $550,000 .
Research and Development Expenses
Since our inception, we have focused our resources on our research and development activities. We expense research and development costs as they are incurred. Our research and development expenses primarily consist of outsourced engineering, product development and manufacturing design costs. For the three months endedJune 30, 2022 and 2021, we incurred$579,061 and$1,070,912 respectively, in research and development costs. For the six months endedJune 30, 2022 and 2021, we incurred$1,110,544 and$2,660,602 respectively, in research and development costs. Research and development expenses decreased by$491,851 and$1,550,058 for the three and six months endedJune 30, 2022 as compared to the prior year period. Research and development activities were higher in the second quarter and first half of 2021 as compared to the current quarter and first half of 2022 due to product development, engineering, testing and regulatory costs incurred to prepare our P?rgo device for launch inJuly 2021 .
Change in Fair Value of Warrant Liability
The fair value of the warrant liability was an increase of$650,000 between the initial measurement date ofJune 24, 2022 andJune 30, 2022 . The non-cash loss of$650,000 resulting from increase in the fair value of the warrant liability was reported in our statement of operations for the three and six months endedJune 30, 2022 . Net Losses Our net losses were$5,172,277 and$2,684,520 for the three months endedJune 30, 2022 and 2021, respectively. Our net losses were$7,750,241 and$4,654,212 for the six months endedJune 30, 2022 and 2021, respectively. Losses increased in the second quarter and first half of 2022 as compared to the second quarter and first half of 2021 for the reasons set forth above.
Liquidity and Capital Resources
Sources of Liquidity
As ofJune 30, 2022 , we had cash of$29,163,429 compared to cash of$19,629,649 as ofDecember 31, 2021 . OnNovember 29, 2021 , we completed our initial public offering (the "IPO") of 2,514,000 shares of our common stock, which included the partial exercise of the underwriters' overallotment option, at a public offering price of$10.00 per share for aggregate gross proceeds of$25,140,000 and net proceeds of approximately$21,640,000 , after deducting underwriting fees and closing costs of approximately$3,500,000 . 19
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The Company issued a purchase option to the underwriters (the "Underwriter Option") exercisable within five years of the IPO for 5.0% of the shares of common stock issued, or 125,700 shares of common stock, at an exercise price of$12.50 per share. OnJune 21, 2022 , 31,192 shares of common stock were issued pursuant to the Underwriter Option. Prior to the IPO,AeroClean Technologies, LLC , our predecessor, funded its operations principally with approximately$15,000,000 in gross proceeds from the sale of Class A units. As ofJune 30, 2022 , we had an accumulated deficit of$7,741,721 . The Company's net cash used in operating activities was$4,312,706 for the six months endedJune 30, 2022 as compared to$3,950,684 used in operating activities for the prior year period. OnJune 29, 2022 , we completed a private placement with a single institutional investor (the "Purchaser") pursuant to which we received gross cash proceeds of$15,000,000 in connection with the issuance of (i) 1,500,000 shares of our common stock and (ii) a common stock purchase warrant (the "Warrant") to purchase up to 1,500,00 shares of our common stock (the "Private Placement"). The Warrant has an exercise price of$11.00 and is exercisable untilJuly 21, 2027 . Net proceeds amounted to$13,578,551 after issuance costs of$1,421,450 , of which$1,326,212 was charged to expense, and$95,237 was charged to additional paid-in capital. The Purchaser has contractually agreed to restrict its ability to exercise the Warrant if the number of shares of common stock held by the Purchaser and its affiliates after such exercise would exceed 4.99% of the then issued and outstanding shares of the common stock. The Purchaser may increase or decrease this limitation upon notice to the Company, but in no event will any such limitation exceed 9.99%. Pursuant to a registration rights agreement between us and the Purchaser, we filed a registration statement on Form S-1, which became effective onJuly 21, 2022 , registering the offering and resale, from time to time, by the Purchaser of up to 3,000,000 shares of our common stock which includes 1,500,000 shares of our common stock issued in the Private Placement and 1,500,00 shares issuable upon the exercise of the Warrant acquired in the Private Placement. We have incurred operating losses since our inception. While the Company began producing and selling its P?rgo device inJuly 2021 , these losses are expected to continue through at least the end of 2022 as we continue to make significant investments to develop and market our products and to establish our consumables and service business.
Future Funding Requirements and Outlook
We have incurred operating losses each year since our inception. These losses are expected to continue through at least the end of 2022 because we plan to continue to make investments to develop and market our products and to establish our consumables and service business. We also expect to continue to incur increased costs to comply with corporate governance, internal controls and similar requirements applicable to public companies. OnFebruary 1, 2021 , we entered into a lease withGarden Bio Science Partners, LLC , an entity controlled by the chair of our board of directors, with a term of ten years at an annual base rent of$260,000 , subject to escalation of 2.5% on an annual basis. As ofJune 30, 2022 , the future minimum lease payments under this arrangement approximated$2,540,000 . Based on our current financial resources, our expected revenues and our expected level of operating expenditures, we believe that we will be able to fund our projected operating requirements for at least the next 12 months from the date of issuance of this Quarterly Report. Over the long-term, the Company will continue to have capital requirements, and expects to devote resources to grow its operations. Moreover, if the Company pursues an acquisition strategy, it may need to raise incremental capital in order to finance the purchase price to be paid to target stockholders. As a result of these funding requirements, we will likely need to obtain additional financing by engaging in debt and/or equity offerings or seeking additional borrowings. To the extent that we raise additional capital through the sale of convertible debt or equity securities, or pay for acquisitions in whole or in part with the issuance of equity securities (either as merger consideration or to finance the cash portion of merger consideration), the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. The availability of debt financing or equity capital will depend upon the Company's financial condition and results of operations as well as prevailing market conditions. 20 Table of Contents Inflation Inflation has adversely affected our business and we expect this to continue through the end of 2022. We have been and expect to continue to be negatively impacted by increased component and logistics costs. In addition, our cost of labor and materials may increase, which would negatively impact our business and financial results. Alternatively, deflation may cause a deterioration of global and regional economic conditions, which could impact unemployment rates and consumer discretionary spending. These, and other factors that may increase the risk of significant deflation, could negatively impact our business and results of operations.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our condensed financial statements, which we have prepared in accordance with accounting principles generally accepted inthe United States of America ("U.S. GAAP"). The preparation of the financial statements in accordance withU.S. GAAP requires us to make estimates and assumptions that affect the reported amounts and related disclosures. We evaluate these estimates, judgments and methodologies on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe are reasonable. Our actual results could differ from those estimates. Our significant accounting policies are more fully described in Note 2, Summary of Significant Accounting Policies to our audited financial statements included in our Annual Report on Form 10-K filed with theSEC onApril 1, 2022 . We believe that the accounting policies are critical for fully understanding and evaluating our financial condition and results of operations.
JOBS Act
OnApril 5, 2012 , the JOBS Act was enacted. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as public companies that are not emerging growth companies. As a result of this election, our financial statements may not be comparable to companies that are not emerging growth companies. We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an "emerging growth company," we intend to rely on certain of these exemptions, including without limitation, (i) an exemption from the requirement to provide an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) an exemption from any requirement that may be adopted by the Public Company Oversight Board ("PCAOB") regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an "emerging growth company" until the earliest of: (i) the last day of the fiscal year in which we have total annual gross revenues of$1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of the IPO; (iii) the date on which we have issued more than$1 billion in non-convertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of theSEC .
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor"
for forward-looking statements to encourage companies to provide prospective
information to investors. This Quarterly Report includes forward-looking
statements that reflect our current expectations and projections about our
future results, performance and prospects. Forward-looking statements include
all statements that are not historical in nature or are not current facts. When
used in this Quarterly Report, the words "believe," "expect," "plan," "project,"
"intend," "anticipate," "estimate," "predict," "potential," "continue," "may,"
"might," "likely," "should," "could," "will," "target" or the negative of these
terms or similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain such identifying
words. These forward-looking statements are based on our current expectations
and assumptions about future events and are based on currently available
information as to the outcome and timing of future events.
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These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause our actual results, performance and prospects to differ materially from those expressed in, or implied by, these forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in our filings with theSEC , in particular those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1, filed with theSEC onJuly 11, 2022 , as amended onJuly 20, 2022 , and in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021 , filed with theSEC onApril 1, 2022 , including the following factors:
?general economic conditions in the markets in which we operate;
?the impact of the COVID-19 pandemic and related prophylactic measures;
?expected timing of regulatory approvals and product launches;
?non-performance of third-party vendors and contractors;
?risks related to our ability to successfully sell our products and the market reception to and performance of our products;
?compliance with, and changes to, applicable laws and regulations;
?our limited operating history;
?our ability to manage growth;
?our ability to obtain additional financing when and if needed;
?our ability to expand the Company's product offerings;
?our ability to compete with others in our industry;
?our ability to protect our intellectual property;
?the ability of certain existing stockholders to determine the outcome of matters which require stockholder approval;
?our ability to retain the listing of our common stock on Nasdaq;
?our ability to defend against legal proceedings; and
?success in retaining or recruiting, or changes required in, our officers, key employees or directors.
In light of these risks, uncertainties and assumptions, you are cautioned not to put undue reliance on any forward-looking statements in this Quarterly Report. These statements should be considered only after carefully reading this entire Quarterly Report. Except as required under the federal securities laws and rules and regulations of theSEC , we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report not to occur.
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