The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Form 10-Q and our audited consolidated financial statements and the related notes thereto and the discussion under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Form 10-K filed with theSEC onMarch 30, 2022 (the "2021 10-K"). Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the sections titled "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in the 2021 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Data as of and for the three months endedMarch 31, 2022 and 2021 has been derived from our unaudited condensed consolidated financial statements appearing at the beginning of this Form 10-Q. Results for any interim period should not be construed as an inference of what our results would be for any full fiscal year or future period. OverviewIsoPlexis is the Superhuman Cell company. Our systems uniquely identify a comprehensive range of multifunctional single cells, i.e. the superhero cells in the human body. These cells enable researchers to understand and predict disease progression, treatment resistance and therapeutic efficacy to advance all of human health. We are a life sciences company building solutions to accelerate the development of curative medicines and personalized therapeutics. Our award-winning single-cell proteomics systems reveal unique biological activity in small subsets of cells, allowing researchers to connect more directly to in vivo biology and develop more precise and personalized therapies. We are enabling deeper access to in vivo biology and driving durable and potentially transformational research on disease in a new era of advanced medicine. We believe our platform is the first to employ both proteomics and single cell biology in an effort to fully characterize and link cellular function to patient outcomes by revealing treatment response and disease progression. Our single cell proteomics platform, which includes instruments, chip consumables and software, provides an end-to-end solution to reveal a more complete view of protein function at an individual cellular level. Since our commercial launch inJune 2018 , our platform has been adopted by the top 15 global biopharmaceutical companies by revenue and nearly three quarters of the comprehensive cancer centers inthe United States to help develop more durable therapeutics, overcome therapeutic resistance, and predict patient responses for advanced immunotherapies, cell therapies, gene therapies, vaccines, and regenerative medicines. Our initial focus has been on developing applications of our platform for cancer immunology and cell and gene therapy. We are now expanding our capabilities to include applications for infectious diseases, inflammatory conditions, and neurological diseases. We currently market and sell our technology with an in-house commercial team inthe United States andEurope . We are also utilizing our distribution network to market and sell across multiple countries, includingAustralia ,Belgium ,Canada ,China ,Czech Republic ,France ,Germany ,Italy ,Israel ,Japan ,Portugal ,Singapore ,South Korea ,Spain ,Switzerland , and theUnited Kingdom . We intend to further expand our international presence by growing our distribution networks inBrazil ,India ,Mexico and beyond. We manufacture our instruments and chip consumables in our manufacturing facilities inBranford, Connecticut and do not outsource any of our production manufacturing to third party contract manufacturers. Certain of our suppliers of components and materials are single source suppliers and we do not have supply agreements with certain suppliers of these critical components and materials beyond purchase orders. As part of our overall risk management strategy, we continue to evaluate and identify alternative suppliers for each of our components and materials. Since our inception inMarch 2013 , we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, conducting research and development activities, and filing patent applications. Prior to the completion of our IPO, we financed our operations primarily through the private placement of our securities, the incurrence of indebtedness and, to a lesser extent, grant income and revenue derived from sales of our instruments and chip consumables. As ofMarch 31, 2022 , our principal source of liquidity was cash, which totaled$97.6 million . We completed our first sale of our systems inJune 2018 and have experienced significant revenue growth in recent periods. Revenue increased to$4.9 million for the three months endedMarch 31, 2022 , as compared to$3.2 million for the three months endedMarch 31, 2021 . Nevertheless, we have incurred recurring losses since inception. For the three months endedMarch 31, 2022 , our net losses were$28.7 million as compared to$15.6 million for the three months ended 20
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March 31, 2021 . As ofMarch 31, 2022 , we had an accumulated deficit of$162.7 million . We expect to continue to incur significant expenses and operating losses for the foreseeable future in connection with ongoing development and business expansion activities, particularly as we continue to:
•expand our research and development activities;
•obtain, maintain and expand and protect our intellectual property portfolio;
•market and sell new and existing products and services; and
•attract, hire and maintain qualified personnel to support our expanding business efforts.
Furthermore, we will incur additional costs associated with operating as a public company, including significant legal, accounting, compliance, investor relations and other expenses that we did not incur as a private company.
As a result of these anticipated expenditures, we will need substantial additional financing to support our continuing operations and pursue our growth strategy. Until such time as we can generate positive cash flows from operations, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, sales of products and services to our customers and, to a lesser extent, grant income. We may be unable to raise additional funds when needed on favorable terms or at all. Our inability to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.
Key Factors Affecting Our Performance
We believe that our financial performance has been, and in the foreseeable future will continue to be, primarily driven by the following factors. While each of these factors presents significant opportunities for our business, they also pose important challenges that we must successfully address in order to pursue our growth strategy and improve our results of operations. Our ability to successfully address the factors below is subject to various risks and uncertainties, including those factors set forth in the section titled "Risk Factors" included in our 2021 10-K.
New Customer Adoption of Our Platform
Our financial performance has been, and in the foreseeable future will continue to be, driven by our ability to increase the adoption of our platform and the installed base of our instruments. We plan to drive new customer adoption through a direct sales and marketing organization inthe United States and parts ofEurope and third party distributors inEurope ,North America , theMiddle East andAsia-Pacific . As ofMarch 31, 2022 , we market and sell our technology with an in-house commercial team of approximately 210 team members and also utilize our distribution network to market and sell across multiple countries.
Recurring Revenues from Sales of our Chip Consumables
Our IsoCode and CodePlex chip consumables represent a source of recurring revenue from customers using our platform across a wide range of applications. Our instruments and consumables are designed to work together exclusively. As we expand our installed base of instruments, we expect consumable revenues to increase on an absolute basis and become an increasingly important contributor to our overall revenues.
Adoption of Our Platform Across Existing Customers' Organizations
There is an opportunity to grow our installed base and expand the number of instruments within organizations that are already utilizing our platform to advance their research and therapeutic development by their purchasing of additional instruments to support multiple locations or to increase capacity.
Adoption of Our Platform for New Applications
We founded our company to help solve critical challenges to accelerating advanced medicines and since our inception, we have developed multiple applications spanning cancer immunology, cell and gene therapy, infectious diseases, inflammatory conditions, and neurological diseases. As we continue to deploy our platform, we intend to concurrently expand the breadth of applications for our technologies to encourage increased use of our platform across our addressable markets. We expect our investments in these efforts to increase as we develop and market new applications, including a diagnostic application. 21
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Components of Our Results of Operations
Revenue
Revenue consists of sales of instruments and consumables in addition to service revenue. Our total revenue for the three months endedMarch 31, 2022 was$4.9 million and$3.2 million for the three months endedMarch 31, 2021 . We expect that our revenue will be less than our expenses for the foreseeable future and that we will experience losses as we continue to expand our business.
Cost of Product and Service Revenue
The Company's cost of product revenue primarily consists of manufacturing related costs incurred in the production process, including personnel and related costs, costs of components and materials, labor and overhead, packaging and delivery costs and allocated costs for facilities and information technology. Cost of service revenue consists primarily of personnel and related costs of service and warranty costs to support our customers.
Research and Development Expenses
Research and development expenses include:
•costs to obtain licenses to intellectual property and related future payments should certain success, development and regulatory milestones be achieved;
•employee-related expenses, including salaries, benefits and stock-based compensation expense;
•costs of purchasing lab supplies and non-capital equipment used in our research and development activities;
•consulting and professional fees related to research and development activities; and
•facility costs, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, and other supplies. We expense research and development costs as incurred. Research and development activities are central to our business model. We expect research and development costs to increase for the foreseeable future as our current development programs progress and new programs are added.
Because of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion costs of our current or future research and development efforts.
General and Administrative Expenses
General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and stock-based compensation, for personnel in executive, finance, business development, facility and administrative functions. Other significant costs include facility costs not otherwise included in research and development expenses, legal fees relating to patent and corporate matters and fees for accounting, tax and consulting services. We anticipate that our general and administrative expenses will increase in the future to support continued expansion of our commercial, development and operating activities and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, lawyers and accountants, among other expenses. Additionally, we anticipate increased costs associated with being a public company, including services associated with maintaining compliance with exchange listing andSEC requirements, director and officer insurance costs and investor and public relations costs.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of compensation related expenses, including salaries, bonuses, benefits, non-cash stock-based compensation, for sales and marketing personnel, advertising and promotion expenses, consulting and subcontractor fees, sales commissions, recruiting fees, and various other selling expenses. We anticipate that our sales and marketing expenses will increase in the future as we pursue our growth mission and as we identify and expand into new markets, including additional worldwide markets. 22
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Grant Income
We are engaged in variousSmall Business Innovation Research ("SBIR") grants with the federal government to help fund the costs of certain research and development activities. We believe that we have complied with all contractual requirements of the SBIR grants through the date of the financial statements. We do not currently expect future grant income to be a material source of funding for the Company.
Research and Development State Tax Credits
Research and development ("R&D") tax credits exchanged for cash pursuant to the Connecticut R&D Tax Credit Exchange Program, which permits qualified small businesses engaged in R&D activities withinConnecticut to exchange their unused R&D tax credits for a cash amount equal to 65% of the value of exchanged credits, are recorded as a receivable and other income in the year the R&D tax credits relate to, as it is reasonably assured that the R&D tax credits will be received, based upon our history of filing for and receiving the tax credits. R&D tax credits receivable where cash is expected to be received by us more than one year after the balance sheet date are classified as noncurrent in the consolidated balance sheets.
Fair Value Adjustment for Warrants and Loan Commitments
Warrants and loan commitments are freestanding financial instruments that qualify as liabilities and assets, respectively, required to be recorded at their estimated fair value at the inception date and remeasured at each reported balance sheet date thereafter until settlement, with gains and losses arising from changes in fair value recognized in the statement of operations during each period. Our preferred share warrants were converted to common share warrants upon our IPO and were reclassified from liabilities to equity for the year endedDecember 31, 2021 . Results of Operations
Comparisons of the Three Months Ended
The following table summarizes our results of operations for the three months endedMarch 31, 2022 and 2021, together with the dollar change in those items: Three months ended March 31, Period to (in thousands) 2022 2021 period change Revenue Product revenue $ 4,454$ 2,927 $ 1,527 Service revenue 457 307 150 Total revenue 4,911 3,234 1,677 Cost of product revenue 2,329 1,550 779 Cost of service revenue 27 24 3 Gross profit 2,555 1,660 895 Operating expenses: Research and development expenses 7,133 3,674 3,459 General and administrative expenses 11,476 4,378 7,098 Sales and marketing expenses 12,043 7,074 4,969 Total operating expenses 30,652 15,126 15,526 Loss from operations (28,097) (13,466) (14,631) Other income (expense), net: Interest expense, net (986) (743) (243) Other income (expense), net 358 (1,350) 1,708 Net loss$ (28,725) $ (15,559) $ (13,166) 23
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Revenue
Total revenue increased$1.7 million for the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 . This consisted primarily of an increase of$0.9 million for instruments,$0.6 million for consumables and$0.2 million in service revenue. The increase in instruments revenue for the three months endedMarch 31, 2022 was driven by an increase in unit sales generated from a larger commercial team, primarily hired in the second half of 2021. The increase in consumable revenue in 2021 was driven by an increase in the number of units at customer locations.
Gross Profit
Gross profit as a percentage of total revenues was 52% for the three months
ended
Research and Development Expenses
Three months ended March 31, Period to (in thousands) 2022 2021 period change Compensation related expenses$ 3,967 $ 1,714 $ 2,253 Professional fees and sub-contractor 428 324 104 Prototyping 442 394 48 Recruiting 115 165 (50) Lab materials 773 179 594 Supplies expense 882 675 207 Depreciation and amortization 154 108 46 Other 372 115 257 Total$ 7,133 $ 3,674 $ 3,459 Research and development expenses increased by$3.5 million , or 94%, for the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily due to increases in compensation related expenses of$2.3 million from hiring approximately 45 new employees year over year, a$0.1 million increase in professional fees and$0.6 million increase in lab materials related to Duomic, Codeplex, and initiatives to reduce material and production costs by unit of our existing products, a decrease of$0.1 million in recruiting expenses, an increase in supplies expense of$0.2 million , and increase in depreciation and amortization expense and other expenses of$0.3 million .
General and Administrative Expenses
General and administrative expenses increased by$7.1 million , or 162%, for the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily due to increases in compensation related expenses of$3.4 million for additional personnel to support organizational growth, an increase of$0.9 million of professional fees related to process enhancements, an increase of$1.0 million in depreciation and amortization expenses primarily related to the amortization of patent expenses, an increase of$0.7 million in software and networking expenses to support a larger organization, and an increase of$1.1 million in various other expenses.
Sales and Marketing Expenses
Sales and marketing expenses increased by$5.0 million , or 70%, for the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily due to increases in compensation related expenses of$3.2 million for additional personnel to support increased activities, an increase in professional fees of$1.3 million related to international staff increases, a decrease in recruiting expenses of$0.4 million , an increase in supplies expense of$0.6 million , and increase in other expense of$0.3 million . Overall, the increase was driven by the increase in headcount to support our growth mission and the hiring of consultants to help us identify and expand into new markets, including worldwide markets. 24
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Interest expense
As a result of the Credit Agreement we entered into onDecember 30, 2020 , we had$38.9 million of borrowings outstanding as ofMarch 31, 2022 , and we recognized$1.0 million in interest expense for the three months endedMarch 31, 2022 .
Liquidity and Capital Resources
AtMarch 31, 2022 , we had$97.6 million in cash and$7.5 million available from our Credit Agreement. Cash as ofMarch 31, 2022 decreased by$29.0 million compared toDecember 31, 2021 , primarily due to the factors described under the heading "-Cash Flows" below. Our primary source of liquidity, other than cash on hand, has been cash flows from issuances of common stock in our IPO, issuances of preferred stock, debt financings and, to a lesser extent, grant income.
Cash Flows
Comparisons of the Three Months Ended
The following table provides information regarding our cash flows for the three
months ended
Three months endedMarch 31 , (in thousands) 2022
2021
Net cash provided by (used in): Operating activities (31,906) (14,421) Investing activities (4,554) (825) Financing activities 7,502 10,005 Net change in cash$ (28,958) $ (5,241) Operating Activities Net cash used by operating activities in the three months endedMarch 31, 2022 primarily consisted of net loss of$28.7 million , partially offset by net non-cash adjustments of$2.8 million , plus net changes in operating assets and liabilities of$6.0 million , including a$10.3 million inventory outflow. The primary non-cash adjustments to net income included share-based compensation of$0.9 million , depreciation and amortization expenses of$1.0 million and amortization of debt discount of$0.4 million . Cash flow impact from changes in net operating assets and liabilities were primarily driven by an increase in inventories and partially offset by increases in accounts payable and a decrease in other assets and accrued liabilities. Net cash used by operating activities in the three months endedMarch 31, 2021 primarily consisted of net loss of$15.6 million , partially offset by net non-cash adjustments of$2.6 million , plus net changes in operating assets and liabilities of$1.5 million . The primary non-cash adjustments to net income were change in fair value of warrants and loan commitment of$1.9 million and depreciation and amortization costs of$0.3 million . Cash flow impacts from changes in net operating assets and liabilities were primarily driven by increases in inventories, accounts receivable and prepaid expense and other current assets, partially offset by increases in accrued liabilities and accounts payable.
Investing Activities
Net cash used in investing activities totaled$4.6 million in the three months endedMarch 31, 2022 . We purchased$4.4 million of property and equipment. We paid$0.2 million related to patents acquired and patent costs that were capitalized. Net cash used in investing activities totaled$0.8 million in the three months endedMarch 31, 2021 . We purchased$0.7 million of property and equipment. We paid$0.1 million related to patents acquired and patent costs that were capitalized. 25
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Financing Activities
Net cash provided by financing activities was
Net cash provided by financing activities was$10.0 million in the three months endedMarch 31, 2021 . We raised cash through the issuance of Series D redeemable convertible preferred stock, with net proceeds of$10.0 million .
Funding Requirements
We expect to continue to generate operating losses in connection with our ongoing activities, particularly as we continue our research and development efforts and expand our business efforts. Furthermore, we have incurred and will continue to incur additional costs as a result of being a public company. Accordingly, we will need to obtain additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with our research and development efforts, we are unable to estimate the exact amount of our operating capital requirements. Our future capital requirements will depend on many factors, including:
•future research and development efforts;
•the need to service and refinance our indebtedness;
•our ability to enter into and terms and timing of any collaborations, licensing agreements or other arrangements;
•the costs of sales, marketing, distribution and manufacturing efforts;
•our headcount growth and associated costs as we expand our business;
•the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against intellectual property related claims; and
•the costs of operating as a public company
Until such time, if ever, as we can generate positive cash flows from operations, we expect to finance our additional cash needs through a combination of equity offerings, debt financings, sales of products and services to our customers and, to a lesser extent, grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, stockholder ownership interest will be diluted, and the terms of those securities may include liquidation or other preferences that adversely affect the rights of holders of common stock. 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. If we raise funds through additional strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or future revenue streams or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity offerings, debt financings or grants when needed, we may be required to delay, limit, or reduce our expansion efforts.
Contractual Obligations and Commitments
Contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude orders for goods and services entered into in the normal course of business that are not enforceable or legally binding. OnDecember 30, 2020 , we entered into the Credit Agreement, which provides for senior secured financing of up to$50.0 million , consisting of a$25.0 million Tranche A term loan and a$25.0 million Tranche B term loan. The Tranche A term loan of$25.0 million was drawn at the initial closing of the Credit Agreement onDecember 30, 2020 . The Credit Agreement was amended onMay 27, 2021 to split the previously remaining$25.0 million delayed draw term loan commitments under the Credit Agreement into a$10.0 million Tranche B term loan and a$15.0 million Tranche C term loan. The Tranche B term loan of$10.0 million was drawn onMay 27, 2021 . The Credit Agreement was amended onMarch 30, 2022 to split the remaining$15.0 million Tranche C term loan into a$7.5 million Tranche C term loan and a 26
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$7.5 million Tranche D term loan. The Tranche C term loan was drawn onMarch 30, 2022 . Our ability to draw the$7.5 million Tranche D term loan remains available throughJune 30, 2022 subject to several conditions, including achieving total revenue of at least$16.8 million for the twelve month period endedMarch 31, 2022 . The Company has achieved this revenue milestone as ofMarch 31, 2022 . Borrowings under the Credit Agreement bear interest at a rate per annum equal to the one-month LIBOR rate (with a minimum LIBOR rate for such purposes of 1.75%) plus a margin of 9.50% (11.25% atMarch 31, 2022 ). Monthly payments of interest only are due over the term of the Credit Agreement with no scheduled loan amortization. Unless accelerated prior to such date, all amounts outstanding under the Credit Agreement are due to be repaid onDecember 30, 2025 . In addition, the Credit Agreement includes a quarterly minimum total revenue covenant for the applicable trailing twelve month period. OnOctober 29, 2021 , we entered into the Second Amendment to, among other things, eliminate the minimum total revenue covenant for the twelve months endingDecember 31, 2021 and reset the total minimum revenue covenants thereafter. Pursuant to the Second Amendment, the minimum total revenue covenant, as amended, has resumed testing for the twelve months endingMarch 31, 2022 . The Company is currently in compliance with the minimum total revenue covenant as ofMarch 31, 2022 . The following table summarizes our commitments to settle contractual obligations as ofMarch 31, 2022 : Less than 1 More than 5 (in thousands) Total year 1-3 Years 4-5 Years years Lease commitments (1)$ 6,186 $ 1,594 $ 3,055 $ 1,537 $ - Purchase obligations (2) 36,875 2,875 9,750 16,750 7,500 Total$ 43,061 $ 4,469 $ 12,805 $ 18,287 $ 7,500 (1) Represents commitments under our non-cancelable leases.
(2) Purchase obligations relate to our Patent Purchase Agreement with
Critical Accounting Policies and Significant Judgments and Estimates
The preparation of financial statements in accordance withU.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. Management bases its estimates on historical experience, market and other conditions, and various other assumptions it believes to be reasonable. Although these estimates are based on management's best knowledge of current events and actions that may impact us in the future, the estimation process is, by its nature, uncertain given that estimates depend on events over which we may not have control. Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty, we continue to use the best information available to inform our critical accounting estimates. If market and other conditions change from those that we anticipate, our consolidated financial statements may be materially affected. In addition, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material effect on our consolidated financial statements. During the three months endedMarch 31, 2022 , there were no material changes to our critical accounting policies and use of estimates from those described under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting Policies and Significant Judgments and Estimates" in the Form 10-K for the year endedDecember 31, 2021 and filed with theSEC onMarch 30, 2022 .
Recent Accounting Pronouncements
Refer to Note 2, "Summary of Significant Accounting Policies," in the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for a discussion of recent accounting pronouncements.
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