SMARTKEM, INC.
The following discussion and analysis of our financial condition and results of
operations should be read together with our unaudited interim condensed
consolidated financial statements and the related notes and other financial
information included in this Report. Some of the information contained in this
discussion and analysis or set forth elsewhere in this Report, including
information with respect to our plans and strategy for our business, includes
forward-looking statements that involve risks and uncertainties as described
under the heading "Cautionary Note on Forward-Looking Statements" below. You
should review the disclosure under the heading "Risk Factors" in this 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
statement.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, including the sections entitled "Risk
Factors" and "Management's Discussion and Analysis of Financial Condition and
Results of Operations," contains express or implied forward-looking statements
that are based on our management's belief and assumptions and on information
currently available to our management. Although we believe that the expectations
reflected in forward-looking statements are reasonable, such statements involve
known and unknown risks, uncertainties and other factors that may cause our
actual results, performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
forward-looking statements. All statements other than statements of historical
fact contained in this Report are forward-looking statements. In some cases, you
can identify forward-looking statements by terminology such as "may," "could,"
"will," "would," "should," "expect," "plan," "anticipate," "believe,"
"estimate," "intend," "predict," "seek," "contemplate," "project," "continue,"
"potential," "ongoing" or the negative of these terms or other comparable
terminology.
These forward-looking statements include, but are not limited to, statements about:
? the implementation of our business model and strategic plans for our business,
technologies and products;
? the rate and degree of market acceptance of any of our products or organic
semiconductor technology in general, including changes due to the impact of (i) new semiconductor
technologies, (ii) the performance of organic semiconductor technology, whether
? perceived or actual, relative to competing semiconductor materials, and (iii)
the performance of our products, whether perceived or actual, compared to
competing silicon-based and other products;
? the timing and success of our, and our customers', product releases;
? our ability to develop new products and technologies;
? our estimates of our expenses, ongoing losses, future revenue and capital
requirements, including our
our needs for additional financing;
? our ability to obtain additional funds for our operations and our intended use
of any such funds;
? our ability to become listed and remain eligible on an over-the-counter
quotation system;
our receipt and timing of any royalties, milestone payments or payments for
? products, under any current or future collaboration, license or other
agreements or arrangements;
our ability to obtain and maintain intellectual property protection for our
? technologies and products and our ability to operate our business without
infringing the intellectual property rights of others;
? the strength and marketability of our intellectual property portfolio;
? our dependence on current and future collaborators for developing,
manufacturing or otherwise bringing our products to market;
? the ability of our third-party supply and manufacturing partners to meet our
current and future business needs;
? our exposure to risks related to international operations;
? our dependence on third-party fabrication facilities;
? the impact of the COVID-19 pandemic and any future communicable disease
outbreak on our business and operations;
? our relationships with our executive officers, directors and significant
stockholders;
our expectations regarding our classification as a "smaller reporting company,"
? as defined under the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), and an "emerging growth company" under the JOBS Act (as defined below)
in future periods;
? our future financial performance;
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? the competitive landscape of our industry;
? the impact of government regulation and developments relating to us, our
competitors or our industry;
? the restatement of previously issued financial statements;
? the identified material weaknesses in our internal control over financial
reporting and our ability remediate those material weaknesses; and
? other risks and uncertainties, including those listed under the caption "Risk
Factors."
These statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under "Risk Factors" and elsewhere in this Form 10-Q. Any forward-looking statement in this Form 10-Q reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our business, results of operations, industry and future growth. Given these uncertainties, you should not place undue reliance on these forward looking statements. No forward-looking statement is a guarantee of future performance. You should read this Form 10-Q and the documents that we reference in this Form 10-Q and have filed with theSEC as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward looking statements for any reason, even if new information becomes available in the future.
Overview
We are seeking to reshape the world of electronics with a revolutionary semiconductor platform that enables a new generation of displays, sensors and logic.SmartKem's patented TRUFLEX® inks are solution deposited at a low temperature, on low-cost substrates to make organic thin-film transistor (OTFT) circuits. Our semiconductor platform can be used in a number of applications including mini-LED displays, AMOLED displays, fingerprint sensors and logic circuits. We develop our materials at our research and development facility inManchester, UK , and at our semiconductor manufacturing process at the Centre of Process Innovation (CPI) in Sedgefield,UK . We have an extensive IP portfolio including approximately 120 issued patents.
Since our inception in 2009, we have devoted substantial resources to the research and development of materials and production processes for the manufacture of organic thin film transistors and the enhancement of our intellectual property.
Our loss before income taxes was$4.0 million and$2.7 million for the three months endedSeptember 30, 2022 and 2021, respectively and$10.4 million and$14.4 million for the nine months endedSeptember 30, 2022 and 2021, respectively. As ofSeptember 30, 2022 , our accumulated deficit was$85.5 million . Substantially all our operating losses have resulted from expenses incurred in connection with research and development activities and from general and administrative costs associated with our operations.
Key Factors Affecting Our Performance
There are a number of industry factors that affect our business which include, among others:
Overall Demand for Products and Applications using Organic Thin Film Transistors
Our potential for growth depends significantly on the adoption of organic thin film transistor (OTFT) materials in the display and sensor markets and our ability to capture a significant share of any market that does develop. We expect that demand for our technology will also fluctuate based on various market cycles, continuously evolving industry supply chains, trade and tariff terms, as well as evolving competitive dynamics in each of the respective markets. These uncertainties make demand difficult to forecast for us and our customers.
Intense and Constantly Evolving Competitive Environment
Competition in the industries we serve is intense. Many companies have made significant investments in product development and production equipment. To remain competitive, market participants must continuously
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increase product performance, reduce costs and develop improved ways to serve their customers. To address these competitive pressures, we have invested in research and development activities to support new product development, improve ease of use, lower product costs and deliver higher levels of performance to differentiate our products in the market.
Governmental Trade and Regulatory Conditions
Our potential for growth depends on a balanced and stable trade, political, economic and regulatory environment among the countries where we do business. Changes in trade policy such as the imposition of tariffs or export bans to specific customers or countries could reduce or limit demand for our products in certain markets.
Technological Innovation and Advancement
Innovations and advancements in organic materials continue to expand the potential commercial application for our products. However, new technologies or standards could emerge, or improvements could be made in existing technologies that could reduce or limit the demand for our products in certain markets.
Intellectual Property Issues
We rely on patented and non-patented proprietary information relating to product development, manufacturing capabilities and other core competencies of our business. Protection of intellectual property is critical. Therefore, steps such as additional patent applications, confidentiality and non-disclosure agreements, as well as other security measures are important. While we believe we have a strong patent portfolio and there is no actual or, to our knowledge, threatened litigation against us for patent-related matters, litigation or threatened litigation is a common method to effectively enforce or protect intellectual property rights. Such action may be initiated by or against us and would require significant management time and expenses.
Components of Results of Operations
There have been no material changes to the key components of our Condensed Consolidated Statements of Operations as described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our 2021
Form 10-K. Results of Operations The following tables set forth our results of operations for the periods presented. The information in the tables below should be read in conjunction with our unaudited interim condensed consolidated financial statements and related notes included in Part I, Item 1 of this Form 10-Q. The period-to-period comparisons of financial results in the tables below are not necessarily indicative of future results.
Comparison of Loss from Operations for the three month-periods ended
Our results of operations for the three month-periods endedSeptember 30, 2022 and 2021 are as follows: Three Months Ended September 30, Increase (Decrease)US$000 2022 2021 Amount Percentage Revenue $ 26 $ -$ 26 100 % Cost of revenue 26 - 26 100 % Gross profit - - - 100 % Other operating income 277 447 (170) (38) % Operating expenses Research and development 1,346 1,356 (10) (1) %
Selling, general and administrative 1,392
1,368 24 2 %
Transaction expenses - - - - %
Total operating expenses 2,738 2,724 14 1 %
Loss from operations $ (2,461) $ (2,277) $ (184) 8 %
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Revenue and Cost of revenue
Revenues were
Cost of revenue was$26 thousand in the three months endedSeptember 30, 2022 , compared with none in the same period of 2021. Cost of revenue resulted from the sale of the OTFT backplanes and materials described above. Other operating income Three Months Ended September 30, Increase (Decrease) % of total % of totalUS$000 2022 2021
Amount Percentage 2022 2021
Research & development tax credit $ 273 $ 446
4 - 4 100 % 1% 0%
Other grants - 1 (1) (100) % 0% 0%
Total other operating income $ 277 $ 447
Other operating income was$277 thousand in the three months endedSeptember 30, 2022 , compared to$447 thousand in the same period of 2021, a decrease of$170 thousand , or 38%. The decrease resulted primarily from a decrease in research and development tax credits resulting from a lower level of eligible expenditure and the impact of adverse exchange rate movements compared to the comparable period of 2021. Operating expenses Three Months Ended September 30, Increase (Decrease) % of total % of totalUS$000 2022 2021 Amount Percentage 2022 2021 Research and development $ 1,346 $ 1,356$ (10) (1) % 49% 50% Selling, general and administrative 1,392 1,368 24 2 % 51% 50% Transaction expenses - - - - % 0% 0% Total operating expenses $ 2,738 $ 2,724$ 14 1 % 100% 100%
Operating expenses of
Research and development expense, which represents 49% and 50% of our total operating expenses for the three months endedSeptember 30, 2022 and 2021, respectively, decreased by$0.1 million compared to the comparable period of 2021 to$1.3 million due to the impact of movements in exchange rates offsetting$0.2 million higher expenditure as we further developed core materials and fabricated demonstrator devices to promote our technology to prospective customers and partners. Selling, general and administrative expense, which represents 51% and 50% of our total operating expenses for the three months endedSeptember 30, 2022 and 2021, respectively, remained at$1.4 million for the quarter as increased expenditure of$0.2 million was offset by the impact of movements in exchange rates. 28
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Non-operating (expense)/income
Three Months Ended September 30, Increase (Decrease)
US$000 2022 2021 Amount Percentage
Loss from operations $ (2,461) $ (2,277) $ (184) 8 %
Non-operating (expense)/income
(Loss)/gain on foreign currency transactions (1,493)
(386) (1,107) 287 %
Interest expense - - - - %
Interest income 1 1 - - %Total non-operating (expense)/income (1,492) (385) (1,107) 288 % Loss before income taxes (3,953)
(2,662) (1,291) 48 %
Income tax expense - - - -
Net loss $ (3,953) $ (2,662) $ (1,291) 48 %
Non-operating expenses for the three months ended September 30, 2022 increased
$1.1 million , or 288%, to $1.5 million , compared to $0.4 million for the three
months ended September 30, 2021 , as a result of higher losses on foreign
currency transactions due to fluctuations in U.S. dollar/U.K. pound value
arising from the translation of foreign currency denominated balances on
intra-group loans and other intra-group balances.
Loss before income taxes was $4.0 million for the three months ended September
30, 2022 , an increase of $1.3 million , or 48%, compared to $2.7 million for the
three months ended September 30, 2021 . The increase in loss before income taxes
was attributable to the $0.2 million lower other operating income and the $1.1
million higher non-operating expenses as described in the preceding paragraphs.
Comparison of Loss from Operations for the nine month-periods ended
Our results of operations for the nine month-periods ended
Nine Months Ended September 30, Increase (Decrease)
US$000 2022 2021 Amount Percentage
Revenue $ 60 $ - $ 60 - %
Cost of revenue 50 - 50 - %
Gross profit 10 - 10 - %
Other operating income 855 1,135 (280) (25) %
Research and development 4,150 6,725 (2,575) (38) %Selling, general and administrative 4,002
6,695 (2,693) (40) %
Transaction expenses - 1,329 (1,329) (100) %
Total operating expenses 8,152 14,749 (6,597) (45) %
Loss from operations $ (7,287) $ (13,614) $ 6,327 (46) %
Revenue and Cost of revenue
Revenues were $60 thousand in the nine months ended September 30, 2022 , compared
with none in the same period of 2021. Revenue in the first three quarters of
2022 resulted from sales of OTFT backplanes and TRUFLEX® materials for customer
assessment and development purposes.
Cost of revenue was $50 thousand in the nine months ended September 30, 2022 ,
compared with none in the same period of 2021. Cost of revenue resulted from the
sale of the OTFT backplanes and materials described above.
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Other operating income
Nine Months Ended
September 30, Increase (Decrease) % of total % of total
US$000 2022 2021 Amount Percentage 2022 2021Research & development tax credit$ 851 $ 945 $ (94) (10) % 100% 83% Research & development grants - 181
(181) (100) % 0% 16% Sale of fixed assets 4 - 4 100 % 0% 0% Other grants - 9 (9) (100) % 0% 1%
Total other operating income
Other operating income was$855 thousand in the nine months endedSeptember 30, 2022 , compared to$1,135 thousand in the same period of 2021, a decrease of$280 thousand , or 25%. The decrease resulted primarily from the absence of research and development grants in the first nine months of 2022, and the adverse impact of exchange rate movements on research and development tax credits recognized compared to the prior period. In the first three quarters of 2021, we received$181 thousand in research and development funding for our work on the "SmartLight" project that successfully demonstrated OTFT mini-LED backlights for displays with improved light uniformity and lower defects.
Operating expenses
Nine Months Ended September 30, Increase (Decrease) % of total % of total
US$000 2022 2021 Amount Percentage 2022 2021
Research and
development $ 4,150 $ 6,725 $ (2,575) (38) % 51% 46%
Selling, general and
administrative 4,002 6,695 (2,693) (40) % 49% 45%
Transaction expenses - 1,329 (1,329) (100) % 0% 9%
Total operating
expenses $ 8,152 $ 14,749 $ (6,597) (45) % 100% 100%
Operating expenses decreased$6.6 million , or 45%, to$8.2 million for the nine months endedSeptember 30, 2022 , compared to$14.7 million for the comparable period of 2021. Research and development expense, which represents 51% and 46% of our total operating expenses for the nine months endedSeptember 30, 2022 and 2021, respectively, decreased by$2.6 million to$4.2 million for the period, primarily due to a$2.7 million decrease in stock compensation expense, a$0.4 million reduction from the effect of exchange rate movement compared to the prior year, partially offset by a$0.5 million increase in expenses incurred in further developing core materials and in fabricating demonstrator devices to promote our technology to prospective customers and partners. Selling, general and administrative expense, which represents 49% and 45% of our total operating expenses for the nine months endedSeptember 30, 2022 and 2021, respectively decreased by$2.7 million to$4.0 million for the period. This decrease was mainly due to a$3.0 million decrease in stock compensation expense, a$0.2 million reduction from the effect of exchange rate movements compared to the prior period, offset by$0.5 million additional expense from the additional legal, accounting and insurance expenses of operating as a public company and from increased marketing and related expenses promoting our products. Transaction costs of$1.3 million associated with the Exchange were incurred in the nine-month period endedSeptember 30, 2021 . The Exchange was consummated during the first quarter of 2021 and no significant additional Exchange-related expenses were recorded thereafter. 30
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Non-operating (expense)/income
Nine Months Ended September 30, Increase (Decrease)
US$000 2022 2021 Amount Percentage
Loss from operations $ (7,287) $ (13,614) $ 6,327 (46) %
Non-operating (expense)/income
Loss on foreign currency transactions (3,131)
(799) (2,332) 292 %
Interest expense - (19) 19 (100) %
Interest income 3 3 - - %
Total non-operating expense (3,128) (815) (2,313) 284 %
Loss before income taxes (10,415) (14,429) 4,014 (28) %
Income tax expense - - - -
Net loss $ (10,415) $ (14,429) $ 4,014 (28) %
Non-operating expenses for the nine months ended September 30, 2022 increased by
$2.3 million , or 284%, to $3.1 million , compared to $815 thousand for the nine
months ended September 30, 2021 , as a result of higher losses on foreign
currency transactions due to fluctuations in U.S. dollar/U.K. pound value
arising from transactions denominated in foreign currencies and the translation
of foreign currency denominated balances on intra-group loans.
Loss before income taxes was $10.4 million for the nine months ended September
30, 2022 , a decrease of $4.0 million , or 28%, compared to $14.4 million for the
nine months ended September 30, 2021 . The decrease in loss before income taxes
was attributable to the lower research and development expense and the lower
selling, general and administrative expense, offset by higher non-operating
expense as described in the preceding paragraphs.
Liquidity and Capital Resources
To date, we have funded our liquidity and capital requirements primarily with proceeds from the private sale of our equity and debt securities and borrowing against our research and development credits. OnJanuary 27, 2022 , we sold an aggregate of 1,000,000 shares of our common stock to existing investors at a price of$2.00 per share for total gross proceeds of$2.0 million . As ofSeptember 30, 2022 , our cash and cash equivalents were$6.3 million compared with$12.2 million as ofDecember 31, 2021 . We believe that our existing cash as ofSeptember 30, 2022 will be sufficient to fund our operations through toApril 2023 if we continue to spend as forecasted to, and that we will require additional capital funding to continue our operations and research and development activity thereafter. There can be no assurance, however, that such financing will be available byApril 2023 , if at all, or on acceptable terms and conditions. The precise amount and timing of the funding needs cannot be determined accurately at this time, and will depend on a number of factors, including the market demand for our products, the quality of product development efforts including potential joint collaborations, management of working capital, and the continuation of normal payment terms and conditions for purchase of services. In order to address our capital needs, including our planned research and development activities and other expenditures, we are assessing options for financing our working capital requirements through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. Adequate financing opportunities might not be available to us, when and if needed, on acceptable terms or at all. 31
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The following table shows a summary of our cash flows for the nine months ended
Nine Months Ended September 30, Increase (Decrease)
US$000 2022 2021 Amount Percentage
Net cash used in operating activities $ (6,835) $ (7,301) $ 466 (6) %
Net cash used by investing activities (67) (282) 215 (76) %
Net cash provided by financing activities 1,830 22,204 (20,374) (92) %
Effect of exchange rate changes on cash (850)
(666) (184) 28 %
Net change in cash (5,922) 13,955 (19,877) (142) %
Cash, beginning of period 12,226 764 11,462 1,500 %
Cash, end of period $ 6,304 $ 14,719 $ (8,415) (57) %
Operating Activities
Net cash used in operating activities was$6.8 million for the nine months endedSeptember 30, 2022 , compared to$7.3 million for the nine months endedSeptember 30, 2021 , a decrease of$0.5 million , or 6%. The decrease resulted primarily from$1.0 million lower supplier payments as transaction expenses were largely settled in the nine months endedSeptember 30, 2021 and a$0.2m favorable impact from changes in exchange rates compared to the prior period, partially offset by$0.6 million higher payroll payments in 2022 reflecting increases in headcount to support our sales and marketing activities and to operate as a public company.
Investing Activities
Net cash used in investing activities was$67 thousand for the nine months endedSeptember 30, 2022 , compared to$282 thousand in the corresponding period of 2021. Net cash used in investing activities in the 2022 period resulted from purchase of laboratory and capital equipment to support our increasing research and development activity. In the future, we expect to continue to incur additional capital expenditures to support our research and development activities and wider business operations.
Financing Activities
Net cash provided by financing activities was$1.8 million for the nine months endedSeptember 30, 2022 , compared to$22.2 million in the corresponding period of 2021, a decrease of$20.4 million , or 92%. During the first half of 2022, we consummated a private placement of our common stock resulting in net proceeds of$1.8 million . In connection with the Exchange inFebruary 2021 , we consummated a private placement resulting in net cash of$22.2 million in the first half of 2021.
Contractual Payment Obligations
Our principal commitments primarily consist of obligations under leases for office space and purchase commitments in the normal course of business for research & development facilities and services, communications infrastructure and administrative services. These will be funded from the Company's cash balances and working capital.
Payments Due by Period
US$(000) 2022 2023 2024 2025 Total
Operating lease liabilities $ 66 $ 218 $ 217 $ 17 $ 518
Purchase obligations 227 486 57 - 770
$ 293 $ 704 $ 274 $ 17 $ 1,288
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Critical Accounting Policies and Estimates
Our unaudited interim condensed consolidated financial statements and the related notes thereto included in this Report are prepared in accordance withU.S. GAAP. The preparation of interim condensed consolidated financial statements also requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. These estimates are developed based on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ significantly from the estimates made by management. To the extent that there are differences between our estimates and actual results, our future financial statement presentation, financial condition, results of operation, and cash flows will be affected. A summary of our critical accounting policies is presented in Note 2 Summary of Significant Accounting Policies to our unaudited interim condensed consolidated financial statements (Part I, Item 1 of this Form 10-Q). There were no material changes to our critical accounting policies during the three and nine months endedSeptember 30, 2022 . A summary of our critical accounting estimates was presented in our management's discussion and analysis of financial condition and results of operations contained in our Annual Report on Form 10-K for the year endedDecember 31, 2021 . There were no material changes to our critical accounting estimates during the three and nine months endedSeptember 30, 2022 .
Going Concern Evaluation
Our unaudited interim condensed consolidated financial statements included elsewhere herein have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We have financed our activities principally from the issuance of ordinary shares, and debt securities. We have experienced recurring losses since inception and expect to incur additional losses in the future in connection with research and development activities.
In the nine months ended
We believe that our existing cash as ofSeptember 30, 2022 will be sufficient to fund our operations through toApril 2023 and that we will require additional capital funding to continue our operations and research and development activity thereafter. There can be no assurance, however, that such financing will be available byApril 2023 , if at all, or on acceptable terms and conditions. The precise amount and timing of the funding needs cannot be determined accurately at this time, and will depend on a number of factors, including the market demand for our products, the quality of product development efforts including potential collaborations, management of working capital, and the continuation of normal payment terms and conditions for purchase of services. In order to address our capital needs, including our planned research and development activities and other expenditures, we are assessing options for financing our working capital requirements through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. Adequate financing opportunities might not be available to us, when and if needed, on acceptable terms or at all. If we are unable to obtain additional financing in sufficient amounts or on acceptable terms, manage working capital, or secure variation to the normal payment terms and conditions, we will be forced to delay, reduce or eliminate some or all of its research and development programs and product portfolio expansion, which could adversely affect our operating results or business prospects. Although management continues to pursue these plans for additional financing, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations byApril 2023 , if at all. After considering the uncertainties, management consider it is appropriate to continue to adopt the going concern basis in preparing the consolidated financial statements. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern. 33 Table of Contents Constant Currency Changes in our financial results include the impact of changes in foreign currency exchange rates. For the three and nine-month periods endedSeptember 30, 2022 and 2021, we did not include the impact of constant currency within this Quarterly Report on Form 10-Q as foreign exchange did not have a significant impact on our reported USD amounts for these periods.
JOBS Act Accounting Election
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act, or the JOBS Act. The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to either early adopt or delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
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