CYTEK(CTKB) - 2024 Q2 - Quarterly Report

PART I FINANCIAL INFORMATION Item 1. Consolidated Financial Statements (Unaudited) This section presents the company's unaudited interim consolidated financial statements and detailed notes for the periods ended June 30, 2024, and December 31, 2023 Consolidated Balance Sheets Consolidated Balance Sheet Highlights (In thousands) | Metric | June 30, 2024 (unaudited) | December 31, 2023 (audited) | | :--- | :--- | :--- | | Total assets | $483,725 | $494,577 | | Total liabilities | $94,602 | $101,393 | | Total stockholders' equity | $389,123 | $393,064 | | Cash and cash equivalents | $177,888 | $167,299 | | Marketable securities | $99,323 | $95,111 | | Trade accounts receivable, net | $44,643 | $55,928 | | Inventories | $50,070 | $60,877 | | Deferred revenue, current | $23,968 | $22,695 | Consolidated Statements of Operations and Comprehensive Loss Consolidated Statements of Operations and Comprehensive Loss (In thousands) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $46,617 | $49,693 | $91,477 | $86,781 | | Gross profit | $25,436 | $28,162 | $48,449 | $49,200 | | Loss from operations | $(8,527) | $(9,127) | $(19,260) | $(21,289) | | Net loss | $(10,434) | $(4,388) | $(16,603) | $(11,195) | | Net loss per share, basic | $(0.08) | $(0.03) | $(0.13) | $(0.08) | | Net comprehensive loss | $(9,075) | $(5,560) | $(15,523) | $(12,257) | Consolidated Statements of Stockholders' Equity Consolidated Statements of Stockholders' Equity (In thousands) | Metric | Balances at December 31, 2023 | Balances at June 30, 2024 | | :--- | :--- | :--- | | Common stock (shares) | 130,714,906 | 131,505,201 | | Common stock (amount) | $131 | $132 | | Additional paid-in capital | $423,386 | $434,967 | | Accumulated deficit | $(29,178) | $(45,781) | | Accumulated other comprehensive loss | $(1,275) | $(195) | | Total stockholders' equity | $393,064 | $389,123 | Consolidated Statements of Cash Flows Consolidated Statements of Cash Flows (In thousands) | Metric | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $10,161 | $8 | | Net cash used in investing activities | $(3,732) | $(166,084) | | Net cash (used in) provided by financing activities | $(98) | $216 | | Effect of exchange rate changes on cash, cash equivalents and restricted cash | $3,957 | $(2,096) | | Net increase (decrease) in cash, cash equivalents and restricted cash | $10,288 | $(167,956) | | Cash, cash equivalents and restricted cash at end of period | $177,918 | $131,544 | Notes to Consolidated Financial Statements 1. Description of Business - Cytek Biosciences, Inc is a cell analysis solutions company leveraging Full Spectrum Profiling (FSP™) technology for high-resolution, high-content, and high-sensitivity cell analysis[14] - On February 28, 2023, Cytek acquired the flow cytometry and imaging business (FCI Business) from Luminex Corporation, expanding its product portfolio[14] 2. Basis of Presentation and Summary of Significant Accounting Policies - The unaudited interim consolidated financial statements are prepared in accordance with GAAP and include wholly-owned subsidiaries[15][16] - The Company operates and manages its business as one reportable and operating segment[18] Cash, Cash Equivalents, and Restricted Cash (In thousands) | Category | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash | $33,797 | $22,407 | | Money market funds | $144,091 | $144,892 | | Restricted cash | $30 | $331 | | Total cash, cash equivalents and restricted cash as presented on the consolidated statements of cash flows | $177,918 | $167,630 | - Restricted cash of $0.3 million was released by June 30, 2024, following the fulfillment of delivery commitments by Cytek Biosciences B.V[23] - Investments are designated as available-for-sale and reported at fair value, with unrealized gains and losses in accumulated other comprehensive loss[24][25] Allowance for Credit Losses (In thousands) | Period | Amount | | :--- | :--- | | Balance at December 31, 2023 | $372 | | Utilization of allowance for credit losses | $(198) | | Provision for credit losses | $125 | | Balance at June 30, 2024 | $299 | Estimated Useful Lives of Property and Equipment | Asset Category | Estimated Useful Lives | | :--- | :--- | | Building | 20 years | | Furniture and fixtures | 7 years | | Laboratory equipment | 5 years | | Office and computer equipment | 3 years | | Leasehold improvements | Shorter of expected lease term or estimated useful life | Estimated Useful Lives of Intangible Assets | Asset Category | Estimated Useful Lives | | :--- | :--- | | Patent | 20 years | | Trademarks | 10 years | | Tradename | 3 - 15 years | | FCI developed technology | 1 - 6 years | | Customer relationship | 7 - 9 years | | Reagent licenses | 7 years | | IP license | 5 years | - Revenue is recognized when control of promised goods or services is transferred to a customer[38][41] - The Company recorded $0.0 million of revenue under bill-and-hold arrangements for the three months ended June 30, 2024, a decrease from $1.0 million in the same period of 2023[38] - Deferred revenue and customer deposits are classified as contract liabilities, representing fees invoiced or paid for services not yet performed[42] - Research and development costs are expensed as incurred, totaling $1.3 million and $2.2 million for advertising, marketing, and media expenses for the three and six months ended June 30, 2024, respectively[45][47] - Stock-based compensation is measured at grant date fair value and expensed over the service period[48] - The Company accounts for income taxes using an asset and liability approach, with an effective income tax rate of (2.6)% for the six months ended June 30, 2024, compared to 28.4% for the same period in 2023[48][94] - Net loss per share is computed using the weighted-average number of common shares outstanding[49] - The Company adopted ASU 2022-04 (Supplier Finance Programs) in Q2 2024, which did not materially affect its consolidated financial statements[52][53] 3. Concentrations of Credit Risk and Other Risks and Uncertainties - The Company's credit risk is primarily concentrated in cash, cash equivalents, and marketable securities, held in major financial institutions and high-credit-rated securities[54] 4. Revenue from Contracts with Customers Disaggregation of Revenue by Sales Channel Mix (In thousands) | Sales Channel Mix | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Direct sales channel | $34,549 | $37,854 | $68,869 | $63,307 | | Distributor channel | $12,068 | $11,839 | $22,608 | $23,474 | | Total revenue, net | $46,617 | $49,693 | $91,477 | $86,781 | Disaggregation of Revenue by Customer Mix (In thousands) | Customer Mix | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Academia and government | $20,239 | $20,405 | $52,834 | $35,602 | | Biotechnology, pharmaceutical, distributor and contract research organizations | $26,378 | $29,288 | $38,643 | $51,179 | | Total revenue, net | $46,617 | $49,693 | $91,477 | $86,781 | Estimated Revenues from Remaining Performance Obligations (In thousands) as of June 30, 2024 | Revenue Type | Less than 1 year | Greater than 1 year | Total | | :--- | :--- | :--- | :--- | | Product revenue | $1,079 | $— | $1,079 | | Service revenue | $22,889 | $14,064 | $36,953 | | Total revenue | $23,968 | $14,064 | $38,032 | Contract Liabilities Roll-Forward (In thousands) | Contract Liabilities | Amount | | :--- | :--- | | Balance at December 31, 2022 | $27,665 | | Revenue recognized | $(36,298) | | Revenue deferred | $47,898 | | Balance at December 31, 2023 | $39,265 | | Revenue recognized | $(22,779) | | Revenue deferred | $22,615 | | Balance at June 30, 2024 | $39,101 | 5. Balance Sheet Details Inventories (In thousands) | Component | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Raw materials | $29,831 | $35,718 | | Work in progress | $6,028 | $10,454 | | Finished goods | $14,211 | $14,705 | | Total inventories | $50,070 | $60,877 | Prepaid Expenses and Other Current Assets (In thousands) | Component | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Prepaid income tax | $7,264 | $5,813 | | Other prepaid expenses and current assets | $4,866 | $6,701 | | Total prepaid expenses and other current assets | $12,130 | $12,514 | Accrued Expenses (In thousands) | Component | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Accrued compensation and related benefits | $10,302 | $13,748 | | Product warranty | $2,238 | $2,805 | | Other accrued expenses | $2,949 | $3,482 | | Total accrued expenses | $15,489 | $20,035 | Other Current Liabilities (In thousands) | Component | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Customer deposits | $1,069 | $1,438 | | Income tax payable | $358 | $1,297 | | Sales and use tax payable | $1,127 | $1,763 | | Operating lease liability, current | $2,407 | $2,444 | | Current portion of loan and line of credit | $1,926 | $565 | | Other | $341 | $396 | | Total other current liabilities | $7,228 | $7,903 | 6. Fair Value of Financial Instruments Fair Value of Financial Assets (In thousands) as of June 30, 2024 | Description | Total | Level 1 | Level 2 | Level 3 | | :--- | :--- | :--- | :--- | :--- | | Money market funds | $144,091 | $144,091 | $— | $— | | U.S. Treasury | $85,439 | $85,439 | $— | $— | | Commercial paper | $13,884 | $— | $13,884 | $— | | Total | $243,414 | $229,530 | $13,884 | $— | Fair Value of Financial Assets (In thousands) as of December 31, 2023 | Description | Total | Level 1 | Level 2 | Level 3 | | :--- | :--- | :--- | :--- | :--- | | Money market funds | $144,892 | $144,892 | $— | $— | | U.S. Treasury | $47,366 | $47,366 | $— | $— | | Federal agency securities | $35,818 | $— | $35,818 | $— | | Commercial paper | $11,927 | $— | $11,927 | $— | | Total | $240,003 | $192,258 | $47,745 | $— | - The Company had no transfers between Level 1, Level 2, or Level 3 for financial assets measured at fair value on a recurring basis during the periods presented[66] 7. Investments Available-for-Sale Securities (In thousands) as of June 30, 2024 | Investment Category | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Loss | Estimated Fair Value | | :--- | :--- | :--- | :--- | :--- | | U.S. Treasury | $85,481 | $— | $(42) | $85,439 | | Commercial paper | $13,905 | $— | $(21) | $13,884 | | Total | $99,386 | $— | $(63) | $99,323 | Contractual Maturities of Available-for-Sale Securities (In thousands) as of June 30, 2024 | Maturity | Amortized Cost | Fair Value | | :--- | :--- | :--- | | Less than one year | $99,386 | $99,323 | | Total | $99,386 | $99,323 | Available-for-Sale Securities (In thousands) as of December 31, 2023 | Investment Category | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Loss | Estimated Fair Value | | :--- | :--- | :--- | :--- | :--- | | U.S. Treasury | $47,347 | $19 | $— | $47,366 | | Federal agency securities | $35,840 | $— | $(22) | $35,818 | | Commercial paper | $11,937 | $— | $(10) | $11,927 | | Total | $95,124 | $19 | $(32) | $95,111 | Contractual Maturities of Available-for-Sale Securities (In thousands) as of December 31, 2023 | Maturity | Amortized Cost | Fair Value | | :--- | :--- | :--- | | Less than one year | $95,124 | $95,111 | | Total | $95,124 | $95,111 | 8. Property and Equipment, Net Property and Equipment, Net (In thousands) | Component | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total property and equipment | $25,120 | $24,325 | | Less: accumulated depreciation | $(7,006) | $(5,920) | | Property and equipment, net | $18,114 | $18,405 | - Total depreciation expense for the three and six months ended June 30, 2024, was $0.9 million and $1.6 million, respectively, an increase from $0.6 million and $1.1 million in the prior year periods[70] 9. Acquisition - On February 28, 2023, Cytek completed the FCI Acquisition for $44.9 million cash, expanding its product portfolio with Amnis and Guava branded instruments and related products[71] - Measurement period adjustments in Q4 2023 resulted in a $3.0 million decrease in goodwill[71][72] Estimated Fair Value of Assets Acquired and Liabilities Assumed at FCI Acquisition Date (In thousands) | Asset/Liability | Fair Value | | :--- | :--- | | Inventories | $18,695 | | Property and equipment | $3,040 | | Deferred tax assets | $570 | | Intangible assets (Customer Relationships, Developed Technology, Tradename) | $21,750 | | Goodwill | $6,038 | | Deferred revenue | $(4,952) | | Other current liabilities | $(316) | | Fair value of net assets acquired | $44,895 | - Goodwill from the FCI Acquisition, primarily attributed to time-to-market advantages and existing relationships, is deductible for tax purposes[72] 10. Goodwill and Intangible Assets, Net Intangible Assets, Net (In thousands) | Component | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total intangible assets | $27,898 | $27,697 | | Less: accumulated amortization | $(6,478) | $(4,613) | | Intangible assets, net | $21,420 | $23,084 | - Total amortization expense for the three and six months ended June 30, 2024, was approximately $0.9 million and $1.9 million, respectively[75] 11. Legal Settlement Liability - Cytek recorded a legal settlement liability of $19.4 million as of June 30, 2024, related to a 2020 agreement with Becton, Dickinson, and Company (BD)[76][77] - The settlement includes a non-exclusive license to BD patents and requires royalty payments, a $6 million milestone payment (achieved in Q4 2021), and a specified payment upon a change of control[76] - Interest expense for the accretion of the legal settlement liability was $0.1 million and $0.4 million for the three and six months ended June 30, 2024, respectively[77] 12. Debt - Cytek Wuxi has a fixed asset loan (Wuxi Loan) of $1.9 million as of June 30, 2024, collateralized by its Wuxi building, with a fixed interest rate of 4.5%[79] - The Company also has a maximum credit agreement for 40 million Chinese renminbi (approx US $5.7 million), collateralized by the Wuxi building, with a $1.4 million short-term loan drawn in February 2024[79] 13. Common Stock - As of June 30, 2024, Cytek Biosciences, Inc had 131,505,201 shares of common stock outstanding[80] - The Company has an 'at-the-market' offering program for up to $150 million of common stock, but no sales have been made as of June 30, 2024[80][81] - A new share repurchase program for up to $50 million was approved on June 6, 2024; during Q2 2024, 444,319 shares were repurchased for $2.7 million, with $47.3 million remaining authorized[81] - Total repurchases across all programs to date amount to 7,058,099 shares for $46.7 million, subject to a 1% excise tax under the Inflation Reduction Act of 2022[82] 14. Stock-Based Compensation Plan - The Company operates three stock-based compensation plans: the 2015 Equity Incentive Plan, the 2021 Equity Incentive Plan, and the 2021 Employee Stock Purchase Plan (ESPP)[83][84][85] Stock Option Activity (In thousands, except share and per share data) | Metric | Number of options outstanding | Weighted-average exercise price | Remaining contractual term (in years) | Aggregate intrinsic value | | :--- | :--- | :--- | :--- | :--- | | Balance as of December 31, 2023 | 7,219,702 | $8.74 | 6.90 | $23,574 | | Options granted | 1,916,670 | $6.86 | | | | Options exercised | (483,157) | $1.51 | | | | Options forfeited | (95,210) | $13.25 | | | | Options expired | (133,785) | $16.18 | | | | Balance as of June 30, 2024 | 8,424,220 | $8.56 | 7.28 | $10,232 | | Options exercisable as of June 30, 2024 | 4,949,291 | $7.95 | 6.19 | $10,034 | - Unrecognized stock-based compensation expense for unvested stock options was $22.1 million as of June 30, 2024, to be recognized over 2.59 years[87] RSU Awards Activity | Metric | Shares | Weighted-average grant date fair value per share | Weighted-average remaining contractual term (in years) | Aggregate intrinsic value (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Unvested balance at December 31, 2023 | 2,608,257 | $10.88 | 1.51 | $23,787 | | Granted | 3,358,467 | $6.97 | | | | Vested | (582,543) | $10.18 | | | | Forfeited | (232,552) | $10.24 | | | | Unvested balance at June 30, 2024 | 5,151,629 | $8.44 | 1.68 | $28,746 | - Unrecognized stock-based compensation expense for unvested RSU awards was $41.2 million as of June 30, 2024, to be recognized over 3.21 years[89] Stock-Based Compensation Expense Allocation (In thousands) | Category | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Cost of sales | $1,200 | $868 | $2,145 | $1,560 | | Research and development | $1,677 | $1,805 | $2,999 | $3,239 | | Sales and marketing | $1,280 | $1,171 | $2,287 | $2,107 | | General and administrative | $2,995 | $2,078 | $5,361 | $3,715 | | Total stock-based compensation | $7,152 | $5,922 | $12,792 | $10,621 | 15. Employee Benefit Plan - The Company contributed approximately $569,732 and $974,025 to its 401(k) retirement savings plan for the three and six months ended June 30, 2024, respectively[93][94] 16. Income Taxes - The Company's effective income tax rate from continuing operations was (2.6)% for the six months ended June 30, 2024, significantly lower than 28.4% for the same period in 2023[94] Provision for (Benefit from) Income Taxes (In thousands) | Period | 2024 | 2023 | Change Amount | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $3,248 | $(2,207) | $5,455 | (247)% | | Six months ended June 30, | $424 | $(4,440) | $4,864 | (110)% | - The increase in tax provision for both periods was primarily due to a lower effective tax rate and an adjustment for restricted stock units settlement price being lower than grant price[97][144] 17. Lease Total Lease Cost (In thousands) | Period | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | | Operating lease cost | $1,433 | $1,596 | | Short-term lease cost | $580 | $368 | | Total lease cost | $2,013 | $1,964 | Supplemental Balance Sheet Information Related to Leases (In thousands) | Metric | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Operating lease right-of-use assets | $9,328 | $10,853 | | Total operating lease liabilities | $10,520 | $11,923 | | Weighted-average remaining lease term | 4.32 years | 4.68 years | | Weighted-average discount rate | 2.7% | 2.7% | Future Undiscounted Cash Flows for Lease Liabilities (In thousands) as of June 30, 2024 | Year | Amount | | :--- | :--- | | 2024 (excluding Q1-Q2) | $1,362 | | 2025 | $2,550 | | 2026 | $2,504 | | 2027 | $2,315 | | 2028 | $2,047 | | Thereafter | $348 | | Total lease payments | $11,126 | | Less imputed interest | $(606) | | Total present value of lease liabilities | $10,520 | 18. Commitments and Contingencies - The Company is not currently involved in any material legal proceedings or litigation[104] 19. Investment in Cytek Japan - Cytek Japan, initially a 50/50 joint venture, became a wholly-owned subsidiary of Cytek in January 2023[105][106] 20. Product Warranty Product Warranty Accrual Activity (In thousands) | Metric | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Balance, beginning of the period | $2,805 | $2,126 | | Accrual for current year warranties | $396 | $3,540 | | Warranty cost incurred | $(963) | $(2,861) | | Balance, end of period | $2,238 | $2,805 | 21. Net Loss Per Share Net Loss Per Share (In thousands, except share and per share data) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(10,434) | $(4,388) | $(16,603) | $(11,195) | | Weighted-average common shares outstanding, basic | 131,440,486 | 135,918,707 | 131,180,734 | 135,705,139 | | Net loss per share, basic | $(0.08) | $(0.03) | $(0.13) | $(0.08) | | Net loss per share, diluted | $(0.08) | $(0.03) | $(0.13) | $(0.08) | - Basic and diluted net loss per share are identical due to the Company being in a net loss position[108] 22. Geographic Areas Geographical Distribution of Revenue (In thousands) | Region | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | United States | $22,393 | $31,440 | $43,751 | $51,280 | | EMEA | $13,773 | $9,084 | $28,900 | $19,115 | | APAC | $8,984 | $7,053 | $15,335 | $13,274 | | Other | $1,467 | $2,116 | $3,491 | $3,112 | | Total revenue, net | $46,617 | $49,693 | $91,477 | $86,781 | Long-Lived Assets by Geographic Area (In thousands) | Region | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | United States | $8,689 | $8,814 | | EMEA | $420 | $325 | | APAC | $9,005 | $9,266 | | Total | $18,114 | $18,405 | - Most of the Company's long-lived assets are located in the United States and Wuxi, China[110] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on financial condition and results of operations for the three and six months ended June 30, 2024 Forward-Looking Statements - The discussion includes forward-looking statements regarding strategy, future operations, financial position, revenues, costs, and plans[113] - Actual results may differ materially from these statements due to various risks and uncertainties[113] Overview - Cytek Biosciences is a leading cell analysis solutions company utilizing Full Spectrum Profiling (FSP™) technology[114] - The FSP platform includes Cytek Aurora, Northern Lights, and Aurora CS systems, supported by software, reagents, and services[114] - Total revenue for the three months ended June 30, 2024, decreased by 6% to $46.6 million, while for the six months, total revenue increased by 5% to $91.5 million[114][116] - The Company operates with a direct sales model in North America, Europe, and parts of APAC (74-75% of revenue) and through third-party distributors elsewhere (25-26% of revenue)[116] - Net loss increased to $10.4 million for the three months and $16.6 million for the six months ended June 30, 2024, primarily due to higher tax expense and foreign exchange losses[116] Key Factors Affecting Our Results of Operations and Future Performance - Future financial performance is driven by global customer adoption of the FSP platform[118] - The expanding installed base of instruments is expected to increase recurring reagent and service revenue[119][120] - Gross margin is expected to improve with increased manufacturing scale and efficiency[121] - The Company plans to expand into new markets, such as immunotherapy and infectious diseases[122] Key Business Metrics Key Business Metrics (In thousands) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Dollar Change (3M) | Six months ended June 30, 2024 | Six months ended June 30, 2023 | Dollar Change (6M) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Direct sales channel | $34,549 | $37,854 | $(3,305) | $68,869 | $63,307 | $5,562 | | Distributor channel | $12,068 | $11,839 | $229 | $22,608 | $23,474 | $(866) | | Total revenue, net | $46,617 | $49,693 | $(3,076) | $91,477 | $86,781 | $4,696 | | Academia and government | $20,239 | $20,405 | $(166) | $52,834 | $35,602 | $17,232 | | Biotechnology, pharmaceutical, distributor and CRO | $26,378 | $29,288 | $(2,910) | $38,643 | $51,179 | $(12,536) | | Total revenue, net | $46,617 | $49,693 | $(3,076) | $91,477 | $86,781 | $4,696 | Known Trends, Events and Uncertainties - Rising inflation and higher recession risk may adversely affect operating results by increasing costs and extending sales cycles[125] - These factors contributed to longer sales cycles and lower operating results for the three months ended June 30, 2024[125] Components of Our Results of Operations - Revenue is generated from product sales and service sales[126] - Cost of sales includes manufacturing costs, inventory write-downs, warranty costs, royalties, and personnel expenses[126] - Operating expenses comprise R&D, sales & marketing, and general & administrative costs[127][129] - Other income (expense), net, includes interest expense, interest income, and foreign exchange gains/losses[129] - Income taxes consist of federal, state, and foreign taxes[129] Results of Operations Comparison of the Three and Six Months Ended June 30, 2024 and 2023 Consolidated Results of Operations (In thousands) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $46,617 | $49,693 | $91,477 | $86,781 | | Gross profit | $25,436 | $28,162 | $48,449 | $49,200 | | Loss from operations | $(8,527) | $(9,127) | $(19,260) | $(21,289) | | Net loss | $(10,434) | $(4,388) | $(16,603) | $(11,195) | | Net comprehensive loss | $(9,075) | $(5,560) | $(15,523) | $(12,257) | Total Revenue, Net Total Revenue, Net (In thousands, except percentages) | Revenue Type | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Amount Change | % Change | Six months ended June 30, 2024 | Six months ended June 30, 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Product | $34,576 | $40,452 | $(5,876) | (15%) | $68,698 | $71,624 | $(2,926) | (4%) | | Service | $12,041 | $9,241 | $2,800 | 30% | $22,779 | $15,157 | $7,622 | 50% | | Total revenue, net | $46,617 | $49,693 | $(3,076) | (6%) | $91,477 | $86,781 | $4,696 | 5% | - The 6% decrease in total revenue for the three months was primarily due to lower product revenue, while the 5% increase for the six months was driven by higher service revenue[133] - Service revenue increased by 30% and 50% for the three and six months, respectively, due to growth in the installed base of instruments[134] Total Cost of Sales, Gross Profit and Gross Margin Total Cost of Sales, Gross Profit and Gross Margin (In thousands, except percentages) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Amount Change | % Change | Six months ended June 30, 2024 | Six months ended June 30, 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Product cost of sales | $15,808 | $16,675 | $(867) | (5%) | $32,554 | $29,352 | $3,202 | 11% | | Service cost of sales | $5,373 | $4,856 | $517 | 11% | $10,474 | $8,229 | $2,245 | 27% | | Total cost of sales | $21,181 | $21,531 | $(350) | (2%) | $43,028 | $37,581 | $5,447 | 14% | | Gross profit | $25,436 | $28,162 | | | $48,449 | $49,200 | | | | Gross margin | 55% | 57% | | | 53% | 57% | | | - Total cost of sales decreased by 2% for the three months but increased by 14% for the six months[134] - Gross profit margin declined to 55% (3 months) and 53% (6 months) in 2024 from 57% in 2023, primarily due to lower product gross margins[134] Product and Service Gross Profit (In thousands, except percentages) | Metric | Three months ended June 30, 2024 | Three months ended June 30, 2023 | Amount Change | % Change | Six months ended June 30, 2024 | Six months ended June 30, 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Product gross profit | $18,768 | $23,777 | $(5,009) | (21%) | $36,144 | $42,272 | $(6,128) | (14%) | | Product gross margin | 54% | 59% | | | 53% | 59% | | | | Service gross profit | $6,668 | $4,385 | $2,283 | 52% | $12,305 | $6,928 | $5,377 | 78% | | Service gross margin | 55% | 47% | | | 54% | 46% | | | Operating Expenses Research and Development Expenses (In thousands, except percentages) | Period | 2024 | 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $10,001 | $12,136 | $(2,135) | (18%) | | Six months ended June 30, | $19,796 | $22,110 | $(2,314) | (10%) | - R&D expenses decreased by 18% (3 months) and 10% (6 months) primarily due to headcount reductions and lower engineering expenses[137] Sales and Marketing Expenses (In thousands, except percentages) | Period | 2024 | 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $12,268 | $14,367 | $(2,099) | (15%) | | Six months ended June 30, | $24,811 | $25,512 | $(701) | (3%) | - Sales and marketing expenses decreased by 15% (3 months) and 3% (6 months) due to reductions in headcount and personnel-related expenses[138] General and Administrative Expenses (In thousands, except percentages) | Period | 2024 | 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $11,694 | $10,786 | $908 | 8% | | Six months ended June 30, | $23,102 | $22,867 | $235 | 1% | - G&A expenses increased by 8% (3 months) due to higher stock-based compensation and professional service fees[140] Interest Expense Interest Expense (In thousands, except percentages) | Period | 2024 | 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $(134) | $(409) | $275 | (67%) | | Six months ended June 30, | $(575) | $(1,082) | $507 | (47%) | - Interest expense decreased by 67% (3 months) and 47% (6 months) primarily due to the accretion of the present value discount related to the BD settlement agreement[140] Interest Income Interest Income (In thousands, except percentages) | Period | 2024 | 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $1,416 | $1,201 | $215 | 18% | | Six months ended June 30, | $2,775 | $3,344 | $(569) | (17%) | - Interest income increased by 18% for the three months but decreased by 17% for the six months, mainly due to a lower average balance of cash and cash equivalents[141] Other Income, Net Other Income, Net (In thousands, except percentages) | Period | 2024 | 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $59 | $1,740 | $(1,681) | (97%) | | Six months ended June 30, | $881 | $3,392 | $(2,511) | (74%) | - Other income, net, declined significantly by 97% (3 months) and 74% (6 months) primarily due to increased realized and unrealized foreign exchange losses in 2024[142] Income Taxes Provision for (Benefit from) Income Taxes (In thousands, except percentages) | Period | 2024 | 2023 | Amount Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three months ended June 30, | $3,248 | $(2,207) | $5,455 | (247%) | | Six months ended June 30, | $424 | $(4,440) | $4,864 | (110%) | - The shift from a tax benefit in 2023 to a provision in 2024 was primarily due to a lower effective tax rate and an adjustment for restricted stock units settlement price[143][144] Liquidity and Capital Resources - As of June 30, 2024, the Company had $277.2 million in cash, cash equivalents, restricted cash, and short-term investments[145] - The Company anticipates significant cash expenditures for R&D, commercialization, market expansion, and capital expenditures[145] - Existing cash and anticipated cash flows are expected to be sufficient for working capital and capital expenditure needs for at least the next 12 months[145] Summary of Cash Flows (In thousands) | Cash Flow Activity | Six months ended June 30, 2024 | Six months ended June 30, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $10,161 | $8 | | Net cash used in investing activities | $(3,732) | $(166,084) | | Net cash (used in) provided by financing activities | $(98) | $216 | | Effect of exchange rate changes on cash, cash equivalents and restricted cash | $3,957 | $(2,096) | | Net increase (decrease) in cash, cash equivalents and restricted cash | $10,288 | $(167,956) | - Net cash provided by operating activities significantly increased to $10.2 million in H1 2024 (from $8k in H1 2023), driven by non-cash expenses and working capital changes[147] - Net cash used in investing activities decreased to $3.7 million in H1 2024 (from $166.1 million in H1 2023), primarily due to lower net purchases of marketable securities[148] - Net cash used in financing activities was $0.1 million in H1 2024, mainly due to share repurchases[149] - There were no material changes to contractual obligations and commitments or off-balance sheet arrangements during the six months ended June 30, 2024[150][151] Critical Accounting Policies, Significant Judgments and Use of Estimates - The preparation of financial statements requires management to make significant estimates and assumptions[152] - There were no material changes to the Company's critical accounting policies during the three months ended June 30, 2024[153] Recently Adopted Accounting Pronouncements - Information regarding recently adopted accounting pronouncements is incorporated by reference from Note 2 of the unaudited interim consolidated financial statements[154] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section discusses the company's exposure to market risks, primarily from fluctuations in foreign currency exchange rates and interest rates Interest Rate Risk - As of June 30, 2024, the Company held $277 million in cash, cash equivalents, and short-term investments, generating variable interest income[156] - Due to the short-term nature of these holdings, the Company does not believe it is exposed to material interest rate risk[156] Foreign Currency Risk - A substantial portion of the Company's revenue and operating expenses are denominated in foreign currencies, primarily the Renminbi and Euro[156] - The Company has not entered into hedging arrangements to minimize these fluctuations but intends to reassess its approach as international operations grow[156] - Neither inflation nor foreign currency risk had a material effect on the business during the periods presented[156] Item 4. Controls and Procedures This section details the evaluation of disclosure controls and procedures, identifying material weaknesses in internal control over financial reporting Evaluation of Disclosure Controls and Procedures - As of June 30, 2024, management concluded that the Company's disclosure controls and procedures were not effective due to identified material weaknesses in internal controls[157] Material Weaknesses - Material weaknesses were identified in the control environment and control activities components of the COSO framework for the year ended December 31, 2023[158] - Control environment deficiencies include an insufficient number of qualified accounting and IT resources[158] - Control activities deficiencies relate to ineffective design/implementation of controls, including inadequate general information technology controls (GITCs)[158] Remediation Plan and Status - The Company is augmenting its workforce with qualified accounting and IT personnel and leveraging external consultants[159] - Remediation efforts include enhancing existing controls, implementing new controls, updating documentation, and expanding education and training[159][161] Changes in Internal Control over Financial Reporting - Other than actions to remediate identified material weaknesses, there were no material changes in internal control over financial reporting during the six months ended June 30, 2024[162] PART II OTHER INFORMATION Item 1. Legal Proceedings This section states that the company is not currently involved in any material pending legal proceedings - The Company is not currently engaged in any material pending legal proceedings[163] Item 1A. Risk Factors This section outlines various risks and uncertainties that could materially affect the company's business, financial condition, and stock price Summary Risk Factors - The Company has a limited operating history and is highly dependent on a limited number of product offerings, which are prone to quarterly revenue fluctuations[165][168] - Reliance on single/sole source suppliers for key components, inability to accurately forecast demand, and manufacturing challenges pose significant risks[165][170][172] - Business success depends on customer adoption by academic, government, and biopharma institutions, and expansion into new markets[166][174][176][178] - Risks include ongoing regulatory obligations, potential product defects, challenges in obtaining intellectual property protection, and the need to raise additional capital[166][167][181][189][220] - Material weaknesses in internal control, concentration of common stock ownership, and potential stock price volatility are also highlighted[167][187][238] Risks Related to Our Business and Strategy - The Company's limited operating history and dependence on a few core products make future performance difficult to predict, with sales cycles of six months or longer[168][170] - Reliance on single/sole source suppliers for key components poses risks of supply interruptions, increased costs, and delays[170] - Inaccurate forecasting of customer demand can lead to inventory shortages or excesses, impacting gross margins[172] - Challenges in manufacturing, scaling capacity, and managing potential product defects could harm growth and reputation[172][181][183] - Future success depends on increasing market penetration and expanding into adjacent markets, which requires significant R&D investment and regulatory approvals[174][180][181] - Dependence on R&D spending by academic and government institutions makes the Company vulnerable to funding reductions[176] - International operations expose the Company to various risks, including regulatory complexities, currency fluctuations, and trade disputes[178][204] - The highly competitive cell analysis market requires continuous innovation and adaptation[178][180] - Acquisitions, joint ventures, and reliance on third-party shipping vendors introduce integration challenges and potential liabilities[183][184] - Inability to expand commercial operations or increase brand awareness could adversely affect business[184][186] - Material weaknesses in internal control over financial reporting could lead to inaccurate financial reporting[187] - The Company may need to raise additional capital, which could dilute ownership or impose restrictive debt covenants[189] - Compromised IT systems or data could lead to regulatory actions, litigation, and business disruptions[196][198] - Business disruptions from natural disasters, pandemics, or other events could seriously harm operations[199][201] - Use of hazardous biological materials and open-source software carries risks of claims and compliance costs[201][203][233] Risks Related to Government Regulation and Our Industry - The Company's Research Use Only (RUO) products may become subject to more stringent FDA regulation[205] - Failure to comply with ongoing regulatory obligations can result in enforcement actions and product recalls[206][207] - Product recalls, whether voluntary or mandated, could significantly impact the Company's business and reputation[208] - Misuse or off-label promotion of products could lead to product liability suits and FDA sanctions[211] - Changes in tariffs or government trade policies, particularly between the U.S. and China, could increase manufacturing costs and disrupt supply chains[209] - Non-compliance with governmental export controls and sanctions programs could lead to investigations and penalties[209] - Stringent and evolving U.S. and foreign data privacy and security laws (e.g., HIPAA, CCPA, GDPR, PIPL) impose significant compliance costs and risks[210][211][212][213] - Non-compliance with anti-corruption and anti-money laundering laws can result in criminal liability and substantial fines[213][214] - Failure to comply with U.S. federal and state fraud and abuse healthcare laws could lead to substantial penalties and exclusion from federal healthcare programs[214][215][216][217][218] Risks Related to Our Intellectual Property - Inability to obtain and maintain broad patent or other intellectual property protection could harm the Company's competitive advantage[220] - Changes in patent laws or their interpretation create uncertainty regarding the enforceability of patents[220][227] - As of June 30, 2024, the Company owns 35 issued U.S. utility patents and 64 pending utility patent applications globally, with U.S. patents expiring between 2025 and 2038[221] - Patents could be found invalid or unenforceable if challenged, leading to loss of exclusive rights[224][225] - Reliance on trademarks and trade names requires adequate protection to build brand recognition[225] - Non-compliance with procedural requirements for intellectual property maintenance could result in loss of rights[225] - Limited foreign intellectual property rights outside key regions may hinder global protection[226] - Third-party claims of intellectual property infringement could lead to significant litigation expenses and damages[227][228][229][232] - Inability to protect trade secrets and know-how would harm the Company's competitive position[233] - Failure of key information technology systems or data breaches could disrupt operations and compromise confidential information[233][234] Risks Related to Ownership of Our Common Stock - The Company's stock price has been and may continue to be highly volatile[235][236] - Substantial future sales of common stock could dilute existing stockholders' ownership and depress the market price[236][238] - Concentration of ownership (approx 50.7%) by executive officers, directors, and principal stockholders may limit new investors' influence[238] - The Company does not intend to pay dividends in the foreseeable future[238] - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change of control[239][240] - Exclusive forum provisions in charter documents may limit stockholders' ability to choose a favorable judicial forum[240] General Risk Factors - Inaccurate estimates or judgments in critical accounting policies could lead to operating results falling below expectations[241] - The Company is exposed to securities class action litigation, which can result in substantial costs[242] - Operating as a public company incurs increased legal, accounting, and compliance costs[242] - Failure to meet Nasdaq's continued listing requirements could result in delisting[243] - Stock price and trading volume are heavily influenced by analyst research[244][245] - The ability to use Net Operating Losses (NOLs) to offset future taxable income may be limited by ownership changes[246] - Changes in effective tax rate or tax liability could adversely affect results[247][248] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports on equity security transactions, including issuer share repurchases and the use of IPO proceeds Unregistered Sales of Equity Securities - There were no unregistered sales of equity securities during the period[251] Issuer Purchases of Equity Securities - On June 6, 2024, the Board approved a new share repurchase program for up to $50 million of outstanding common stock[252][253] Issuer Purchases of Equity Securities (Three months ended June 30, 2024) | Period | Total number of shares repurchased | Average price paid per share | Total number of shares purchased as part of publicly announced plans or programs | Remaining dollar that may yet be purchased under the plans or programs | | :--- | :--- | :--- | :--- | :--- | | April 1 - April 30, 2024 | — | $— | — | $— | | May 1 - May 31, 2024 | — | $— | — | $— | | June 1 - June 30, 2024 | 444,319 | $5.99 | 7,058,099 | $47,300,000 | | Life to Date Total | 444,319 | $5.99 | 7,058,099 | $47,300,000 | Use of Proceeds - There has been no material change in the use of proceeds from the July 2021 IPO, which generated approximately $215.7 million net proceeds[254] Item 3. Defaults Upon Senior Securities This section confirms no defaults upon any senior securities during the reported period - There were no defaults upon senior securities[256] Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable to the Company[256] Item 5. Other Information This section provides other relevant information, specifically detailing Director and Officer trading arrangements Director and Officer Trading Arrangements Director and Officer Trading Arrangements (Three months ended June 30, 2024) | Name and Position | Action | Adoption/Termination Date | Type of Trading Arrangement (Rule 10b5-1) | Total Shares of Common Stock to be Sold | Expiration Date | | :--- | :--- | :--- | :--- | :--- | :--- | | Ming Yan, Chief Technology Officer and Director | Termination | May 28, 2024 | X | 1,280,000 | February 14, 2025 | - Ming Yan, CTO and Director, terminated a Rule 10b5-1 trading arrangement on May 28, 2024, for 1,280,000 shares[257][258] Item 6. Exhibits This section lists the exhibits filed with the Quarterly Report on Form 10-Q - Exhibits include Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, and certifications from the Principal Executive Officer and Principal Financial Officer[260] - Certifications under 18 U.S.C. Section 1350 are furnished, not filed, and not incorporated by reference into other SEC filings[261]