Treace(TMCI) - 2023 Q1 - Quarterly Report

Special Notes Regarding Forward-Looking Statements This section provides important disclaimers and context for forward-looking statements, highlighting inherent risks and uncertainties that could impact future results Forward-Looking Statements Overview This section provides a standard disclaimer regarding forward-looking statements, outlining various factors that could cause actual results to differ materially from expectations - Forward-looking statements are identified by terms such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'will,' and similar expressions, indicating future events or trends[10] - Key areas covered by forward-looking statements include product use, business growth, cash utilization, reimbursement, personnel, supply chain, product development, regulatory clearances, market expansion, compliance, financial estimates, economic impacts, clinical studies, and the effects of the COVID-19 pandemic[11] - Actual results may differ materially from expectations due to unpredictable events and various known and unknown risks, uncertainties, and other factors, some of which are beyond the company's control[12] PART I—FINANCIAL INFORMATION This section presents the company's unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Unaudited Condensed Financial Statements This section presents the company's unaudited condensed financial statements, detailing balance sheets, operations, equity, cash flows, and related notes Condensed Balance Sheets This section presents the company's condensed balance sheets, detailing assets, liabilities, and stockholders' equity at specific reporting dates | Metric (in thousands) | March 31, 2023 | December 31, 2022 | Change | | :-------------------- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $29,613 | $19,473 | +$10,140 | | Marketable securities, short-term | $141,049 | $61,779 | +$79,270 | | Total current assets | $223,133 | $133,402 | +$89,731 | | Total assets | $249,170 | $159,024 | +$90,146 | | Total current liabilities | $23,296 | $30,245 | -$6,949 | | Total liabilities | $91,553 | $98,495 | -$6,942 | | Total stockholders' equity | $157,617 | $60,529 | +$97,088 | Condensed Statements of Operations and Comprehensive Loss This section presents the company's condensed statements of operations and comprehensive loss, outlining revenues, expenses, and net loss over specified periods | Metric (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (YoY) | | :-------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Revenue | $42,195 | $29,047 | +45.3% | | Cost of goods sold | $8,039 | $5,130 | +56.7% | | Gross profit | $34,156 | $23,917 | +42.8% | | Sales and marketing | $33,655 | $22,299 | +50.9% | | Research and development | $3,412 | $3,052 | +11.8% | | General and administrative | $10,865 | $6,662 | +63.1% | | Total operating expenses | $47,932 | $32,013 | +49.7% | | Loss from operations | $(13,776) | $(8,096) | +70.2% | | Net loss | $(13,454) | $(9,036) | +48.9% | | Net loss per share (basic & diluted) | $(0.23) | $(0.16) | +43.8% | Condensed Statements of Stockholders' Equity (Deficit) This section details changes in the company's stockholders' equity (deficit), including common stock, additional paid-in capital, and accumulated deficit | Metric (in thousands) | December 31, 2022 | March 31, 2023 | Change | | :-------------------- | :---------------- | :------------- | :----- | | Common Stock (shares) | 55,628,208 | 61,280,703 | +5,652,495 | | Common Stock (amount) | $55 | $61 | +$6 | | Additional Paid-In Capital | $145,221 | $255,786 | +$110,565 | | Accumulated Deficit | $(84,720) | $(98,174) | -$(13,454) | | Total Stockholders' Equity | $60,529 | $157,617 | +$97,088 | - The issuance of common stock from a public offering, net of issuance costs and underwriting discount of $7.5 million, contributed $107.5 million to additional paid-in capital[23] Condensed Statements of Cash Flows This section presents the company's condensed statements of cash flows, categorizing cash movements from operating, investing, and financing activities | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(17,259) | $(7,241) | | Net cash used in investing activities | $(80,480) | $(1,481) | | Net cash provided by financing activities | $107,879 | $1,372 | | Net increase (decrease) in cash and cash equivalents | $10,140 | $(7,350) | | Cash and cash equivalents at end of period | $29,613 | $98,483 | - Proceeds from the public offering of common stock, net of costs, provided $107.5 million in financing activities in Q1 2023[26] - Investing activities included $99.6 million in purchases of marketable securities, partially offset by $20.5 million in maturities[26] Notes to Condensed Financial Statements This section provides detailed explanations and disclosures supporting the condensed financial statements, covering accounting policies, fair value measurements, and specific balance sheet components Formation and Business of the Company This section describes the company's core business, its focus on surgical management of bunion and midfoot deformities, and recent capital-raising activities - Treace Medical Concepts, Inc. is a medical technology company focused on advancing the standard of care for surgical management of bunion and related midfoot deformities, primarily through its Lapiplasty® 3D Bunion Correction System and Adductoplasty® Midfoot Correction System[28] - The company completed a follow-on public offering on February 10, 2023, generating net proceeds of $107.5 million after deducting underwriting discounts and offering expenses[29] - As of March 31, 2023, the company had an accumulated deficit of $98.2 million but held $29.6 million in cash and cash equivalents and $141.0 million in marketable securities[30] - Management believes that the company's existing cash, cash equivalents, and marketable securities will allow it to continue planned operations for at least the next 12 months[31] Summary of Significant Accounting Policies This section outlines the key accounting principles and policies applied in preparing the interim condensed financial statements, including estimates and assumptions - The interim condensed financial statements are prepared in accordance with U.S. GAAP and SEC rules, relying on management's estimates and assumptions[32][36] - A $0.4 million reclassification of surgical instrument expense from cost of goods sold to sales and marketing expense was made for the three months ended March 31, 2022, with no effect on net loss[34] - The company did not have material cash deposits at Silicon Valley Bank at the time of the FDIC takeover or as of March 31, 2023, mitigating concentration of credit risk concerns[38] Recent Accounting Pronouncements This section discusses the adoption and impact of recent accounting standards on the company's financial reporting - The company adopted ASU 2016-13, Financial Instruments – Credit Losses, as of January 1, 2023[40] - Adoption of ASU 2016-13 did not have a material impact on the company's financial position, results of operations, or disclosures[40] Fair Value Measurements This section details the categorization and valuation methodologies for assets and liabilities measured at fair value, primarily cash equivalents and marketable securities - Assets and liabilities recorded at fair value are categorized into Level 1 (unadjusted quoted prices in active markets for identical assets) and Level 2 (observable inputs for similar assets or liabilities), with no Level 3 assets or liabilities[42][43][44] | Asset Category (in thousands) | March 31, 2023 (Total Fair Value) | December 31, 2022 (Total Fair Value) | | :---------------------------- | :-------------------------------- | :----------------------------------- | | Cash equivalents | $26,147 | $16,211 | | Short-term marketable securities | $141,049 | $61,779 | | Total | $167,196 | $77,990 | - The fair value of Level 1 securities is determined by trade prices in active markets, while Level 2 securities use valuation models with observable inputs such as interest rates, yield curves, and credit spreads[46] Balance Sheet Components This section provides a detailed breakdown of specific balance sheet accounts, including cash, marketable securities, property and equipment, and accrued liabilities | Category | March 31, 2023 | December 31, 2022 | | :---------------- | :------------- | :---------------- | | Cash | $3,466 | $3,262 | | Money market funds | $12,289 | $13,141 | | Commercial paper | $998 | $323 | | Corporate debt | $8,358 | $2,197 | | Yankee CD | $4,502 | $550 | | Total | $29,613 | $19,473 | | Category | March 31, 2023 | December 31, 2022 | | :---------------------------- | :------------- | :---------------- | | U.S. treasury and government agencies | $56,765 | $16,443 | | Commercial paper | $2,550 | - | | Corporate debt | $33,570 | $23,372 | | Asset-backed securities | $29,845 | $13,896 | | Yankee CD | $18,319 | $8,068 | | Total | $141,049 | $61,779 | | Category | March 31, 2023 | December 31, 2022 | | :---------------------------- | :------------- | :---------------- | | Capitalized surgical equipment | $9,886 | $9,248 | | Total property and equipment, net | $15,915 | $15,338 | | Category | March 31, 2023 | December 31, 2022 | | :------------------------ | :------------- | :---------------- | | Accrued royalties expense | $1,827 | $2,299 | | Accrued professional services | $2,083 | $1,727 | | Other accrued expense | $3,649 | $1,778 | | Total accrued liabilities | $7,971 | $6,216 | Long-Term Debt This section details the company's long-term debt obligations, including loan facilities and their terms, interest rates, and future principal payment schedules | Category | March 31, 2023 | December 31, 2022 | | :------------------------ | :------------- | :---------------- | | MidCap revolving loan facility | $4,000 | $4,000 | | MidCap term loan facility | $50,000 | $50,000 | | Total long-term debt, net | $52,785 | $52,711 | - The company entered into a new five-year $150.0 million loan facility with MidCap in April 2022, comprising up to $120.0 million in term loans and a $30.0 million revolving loan facility[55] - As of March 31, 2023, the term loan and revolving loan facility are accruing interest at capped rates of 9% and 7%, respectively[58] - Future principal payments for long-term debt are scheduled for 2026 ($33.3 million) and 2027 ($20.7 million)[54] Commitments and Contingencies This section outlines the company's contractual commitments, such as royalty expenses, and any contingent liabilities - Royalty expense under agreements with surgeon advisory board members was $1.6 million for the three months ended March 31, 2023, at an aggregate rate of 3.9%, compared to $1.4 million (4.8%) for the same period in 2022[60] - There were no accrued contingent liabilities as of March 31, 2023, and December 31, 2022[61] Stockholders' Equity This section details changes in stockholders' equity, including stock option and restricted stock unit grants, and share-based compensation expenses - During Q1 2023, the company granted 727,650 stock options (weighted-average fair value of $10.58 per share) and 571,565 restricted stock units (RSUs) (weighted-average fair value of $24.07 per share)[63][64] | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Cost of goods sold | $76 | $0 | | Sales and marketing expense | $822 | $531 | | Research and development expense | $257 | $150 | | General and administrative expense | $1,537 | $728 | | Total | $2,692 | $1,409 | Net Loss Per Share Attributable to Common Stockholders This section presents the calculation of basic and diluted net loss per share, considering common stock outstanding and potentially dilutive securities | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss (in thousands) | $(13,454) | $(9,036) | | Weighted-average common stock outstanding | 58,723,760 | 54,827,665 | | Net loss per share (basic and diluted) | $(0.23) | $(0.16) | - Potentially dilutive securities, including 7,717,414 common stock options and 1,086,697 unvested full value awards as of March 31, 2023, were excluded from diluted EPS computation because their inclusion would be antidilutive due to the net loss[67] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's analysis of the company's financial condition and operational results, including business developments, external impacts, and comparative performance Overview This section provides a high-level introduction to the company's business, its primary products, and recent financial activities - Treace Medical Concepts is a medical technology company focused on advancing the standard of care for surgical management of bunion and related midfoot deformities, primarily through its Lapiplasty® 3D Bunion Correction System and Adductoplasty® Midfoot Correction System[70] - The company has sold more than 70,000 Lapiplasty Procedure Kits in the United States since receiving 510(k) clearance in March 2015[71] - A follow-on public offering completed on February 10, 2023, generated net proceeds of $107.5 million, adding to the company's liquidity[72] COVID-19 Impact This section assesses the historical and potential future impacts of the COVID-19 pandemic on the company's business operations and financial results - The COVID-19 pandemic intermittently impacted business operations and financial results in 2020 and 2021 due to reduced elective procedures and limited hospital staffing[73] - The company believes the COVID-19 pandemic did not have a significant impact on its 2022 or first quarter 2023 operations and financial results[73] - Uncertainty remains regarding potential future negative impacts if more contagious and virulent variants of the virus emerge[74] Economic Environment This section discusses the anticipated effects of macro-economic challenges, such as inflation and rising interest rates, on the company's costs and demand - The company expects macro-economic challenges, including inflationary pressures, rising interest rates, and ongoing supply chain issues, to continue throughout 2023[75] - These challenges may result in higher costs, longer lead times from suppliers, and potentially reduced demand for elective surgeries[75] Key Business Metrics This section presents key operational metrics, including Lapiplasty Procedure Kits sold, average sales price, active surgeons, and surgeon utilization rates | Metric | Three Months Ended March 31, 2023 | Change (YoY) | | :------------------------------------ | :-------------------------------- | :----------- | | Lapiplasty Procedure Kits sold | +1,480 units | +28% | | Blended average sales price per kit | $6,244 | +13% | | Active surgeons | 2,499 | +31.5% | | Surgeon utilization rate (kits per active surgeon) | 10.5 | +3.2% | Factors Affecting Our Business This section outlines various internal and external factors influencing the company's business performance, including product adoption, innovation, seasonality, and reimbursement Adoption of the Lapiplasty System This section discusses the company's strategy for increasing market acceptance and distribution of its Lapiplasty System and ancillary products - Business growth depends on gaining broader acceptance and successful marketing and distribution of the Lapiplasty System and ancillary products[79] - The company has approval at over 2,000 facilities across the United States and plans to increase access by educating surgeons and facility administrators[79] - The company expects to continue operating at a loss in the near term, financing operations primarily through offerings of capital stock and debt[79] Investments in Innovation and Growth This section details the company's strategic investments in sales force expansion, patient outreach, and research and development for new product innovations - The company is expanding its U.S. sales force and management team, and increasing patient-focused outreach and education campaigns[81] - Ongoing research and development focuses on next-generation Lapiplasty System innovations, including Mini-Incision and Micro-Lapiplasty Minimally Invasive Systems, and improving core instrumentation[81] - New products introduced in 2022 include the 3-n-1™ Guide, S4A™ plating system, and SpeedRelease™ Instrument[81] - The Adductoplasty System was commercially launched in September 2021 to address midfoot deformities[82] - These investments are expected to increase net losses in the near term but are anticipated to positively impact business and results of operations in the longer term[83] Seasonality This section explains the seasonal patterns in the company's sales volumes, with higher activity in the fourth quarter and lower in the first - The company experiences seasonality with higher sales volumes in the fourth calendar quarter (historically 35% to 40% of full-year revenues) and lower sales volumes in the first calendar quarter[84] - Fourth-quarter sales are typically higher as patients elect surgery after meeting annual deductibles and having time to recover over winter holidays[84] - First-quarter sales tend to be lower due to adverse weather and the resetting of annual patient healthcare insurance plan deductibles[84] Coverage and Reimbursement This section addresses the importance of third-party payor coverage and reimbursement for the company's products and procedures - Sales of the company's products depend, in part, on the extent to which procedures using its products are covered by third-party payors, including government programs and private insurance plans[85] - Based on 2017 claims data, private payors covered approximately 63% of Lapidus cases and 60% of all bunion surgical cases[85] - Primary CPT codes for the Lapiplasty Procedure (CPT 28297 and CPT 28740) are grouped under Medicare APC 5114, while CPT 28730 for multiple tarsometatarsal joint fusion is classified under APC 5115[86] Components of Our Results of Operations This section breaks down the key components of the company's financial performance, including revenue, cost of goods sold, gross profit, and operating expenses Revenue This section describes the primary sources of the company's revenue and factors influencing its growth and fluctuations - Significant revenue is derived from the sale of proprietary Lapiplasty and Adductoplasty Systems and ancillary products to physicians, surgeons, hospitals, and ambulatory surgery centers in the United States[87] - No single customer accounted for 10% or more of the company's revenue during the three months ended March 31, 2023[88] - Revenue is expected to increase in absolute dollars with the expansion of sales territories, new accounts, and trained physician base, though it may fluctuate due to seasonality and macro-economic conditions[88] Cost of Goods Sold This section details the components of the cost of goods sold, including manufacturing costs, royalties, and inventory provisions - Cost of goods sold primarily consists of manufacturing costs for products purchased from third-party manufacturers, including materials and assembly markup[89] - Other components include royalties, allocated overhead for indirect labor, direct shipping costs, personnel costs, and provisions for excess and obsolete inventories[89] - Cost of goods sold is expected to increase in absolute dollars as more products are sold[89] Gross Profit and Gross Margin This section defines gross profit and gross margin, and discusses factors impacting their levels - Gross profit is calculated as revenue less cost of goods sold, and gross margin as gross profit divided by revenue[90] - Gross margin is affected by average selling prices, production and ordering volumes, changes in customer mix, third-party manufacturing costs, and cost-reduction strategies[90] Operating Expenses This section outlines the various categories of operating expenses, including sales and marketing, research and development, and general and administrative costs Sales and Marketing This section details the components of sales and marketing expenses and their expected trends due to growth investments - Sales and marketing expenses primarily include compensation for personnel (salaries, bonuses, commissions, share-based compensation), surgical instrument expense, physician education, training, shipping, direct-to-patient outreach, advertising, and market research[91] - These expenses are expected to continue increasing in absolute dollars due to ongoing investments in the direct sales force and expanded marketing efforts[91] Research and Development This section describes the nature of research and development expenses and anticipated increases from innovation investments - R&D expenses cover engineering, product development, clinical studies, regulatory expenses, and other costs associated with products and technologies in development, including personnel compensation, supplies, and consulting[93] - R&D expenses are expected to increase in absolute dollars due to continued hiring and investment in next-generation Lapiplasty System innovations and related products[93] General and Administrative This section outlines the components of general and administrative expenses and their expected growth due to infrastructure expansion and public company costs - G&A expenses primarily consist of compensation for finance, IT, legal, and human resource functions, professional services fees (legal, audit, tax), insurance costs, and general corporate expenses[94] - These expenses are expected to increase in absolute dollars due to hiring personnel, expanding infrastructure to support growth, and costs associated with operating as a public company[94] Interest income This section describes the sources of the company's interest income, primarily from money market funds and marketable securities - Interest income is derived from interest received on the company's money market funds and marketable securities[95] Interest Expense This section details the components of interest expense, including interest incurred and amortization of debt-related costs - Interest expense consists of interest incurred and amortization of debt discount and issuance costs related to outstanding borrowings[96] Results of Operations (Comparison of the three months ended March 31, 2023 and 2022) This section provides a detailed comparative analysis of the company's financial performance for the three months ended March 31, 2023, versus 2022 | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (Amount) | Change (%) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :-------------- | :--------- | | Revenue | $42,195 | $29,047 | $13,148 | 45.3% | | Cost of goods sold | $8,039 | $5,130 | $2,909 | 56.7% | | Gross profit | $34,156 | $23,917 | $10,239 | 42.8% | | Sales and marketing | $33,655 | $22,299 | $11,356 | 50.9% | | Research and development | $3,412 | $3,052 | $360 | 11.8% | | General and administrative | $10,865 | $6,662 | $4,203 | 63.1% | | Total operating expenses | $47,932 | $32,013 | $15,919 | 49.7% | | Loss from operations | $(13,776) | $(8,096) | $(5,680) | 70.2% | | Interest income | $1,479 | $9 | $1,470 | * | | Interest expense | $(1,285) | $(951) | $(334) | 35.1% | | Net loss | $(13,454) | $(9,036) | $(4,418) | 48.9% | - Revenue increased by $13.1 million (45.3%) in Q1 2023, driven by a 28% increase in Lapiplasty Procedure Kits sold and a 13% increase in average blended revenue per case due to increased adoption of newer technologies and ancillary products[98] - Gross profit margin decreased from 82.3% in Q1 2022 to 80.9% in Q1 2023, primarily due to increased payroll costs and inventory provisions, partially offset by lower royalty rates on newer products[99] - Sales and marketing expenses increased by $11.4 million (50.9%) due to higher payroll and related expenses from increased headcount, higher commissions, increased advertising spending for direct-to-consumer campaigns, and increased training and clinical-related expenses[100] - General and administrative expenses increased by $4.2 million (63.1%) due to higher payroll and related costs from increased headcount, increased rent expense for the new headquarters, and a rise in legal expenses[102] - Interest income increased significantly by $1.5 million due to higher cash balances invested in marketable securities following the equity offering and higher interest rates[103] Liquidity and Capital Resources This section discusses the company's financial position, sources of capital, and ability to meet its short-term and long-term funding requirements Liquidity and Capital Resources Overview This section provides an overview of the company's capital sources, current liquidity, and management's assessment of future funding sufficiency - The company's capital sources include $107.6 million net proceeds from its IPO in April 2021, a $150.0 million loan facility with MidCap (April 2022), and $107.5 million net proceeds from a follow-on public offering in February 2023[106] - As of March 31, 2023, the company had $29.6 million in cash and cash equivalents, $141.0 million in marketable securities, and $54.0 million in principal outstanding under term and revolving loans[107] - Management believes existing cash, cash equivalents, marketable securities, available debt borrowings, and expected revenues are sufficient to meet capital requirements and fund operations for at least the next twelve months[107] Funding Requirements This section outlines the company's anticipated future capital needs and potential methods for securing additional funding - The company expects increased operating expenditures for sales and marketing, R&D, and general and administrative functions to support anticipated growth and public company operations[108] - Future funding requirements depend on factors such as investment in commercial infrastructure, marketing efforts, market acceptance of products, intellectual property costs, and potential acquisitions[109][114] - Additional capital may be sought through public or private equity offerings or debt financings, which could lead to stockholder dilution or restrictive covenants[110] Cash Flows This section analyzes the company's cash flow activities from operations, investing, and financing for the reported periods | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(17,259) | $(7,241) | | Net cash used in investing activities | $(80,480) | $(1,481) | | Net cash provided by financing activities | $107,879 | $1,372 | | Net increase (decrease) in cash and cash equivalents | $10,140 | $(7,350) | - Net cash provided by financing activities was $107.9 million for Q1 2023, primarily from $107.5 million in net proceeds from the public offering of common stock[116] - Net cash used in operating activities for Q1 2023 was $17.3 million, driven by a net loss of $13.5 million and an increase in net operating assets (e.g., inventories, prepaid expenses), partially offset by accounts receivable collections[112] - Net cash used in investing activities for Q1 2023 was $80.5 million, mainly due to $99.6 million in purchases of marketable securities, partially offset by $20.5 million in maturities[114] Critical Accounting Policies and Estimates This section highlights the accounting policies and estimates that require significant management judgment and could materially affect financial results - The company's financial statements are based on management's estimates and assumptions, which are informed by historical experience and current events, and actual results may differ materially[119] - There were no material changes to the company's critical accounting policies and estimates during the three months ended March 31, 2023[120] Recently Issued Accounting Pronouncements This section addresses the impact of new accounting standards on the company's interim financial statements - No newly issued accounting pronouncements impacted the company's unaudited interim financial statements during the period[121] Item 3. Quantitative and Qualitative Disclosure About Market Risk As a smaller reporting company, Treace Medical Concepts, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a smaller reporting company[122] Item 4. Controls and Procedures Management, with the participation of the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2023, providing reasonable assurance for timely and accurate reporting - Management concluded that disclosure controls and procedures were effective as of March 31, 2023, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[123] - There was no change in internal control over financial reporting that materially affected, or is reasonably likely to materially affect, the company's internal control over financial reporting during the period[124] - Management acknowledges the inherent limitations of any control system, which can provide only reasonable, not absolute, assurance against errors and fraud[125] PART II—OTHER INFORMATION This section contains additional information not included in the financial statements, such as legal proceedings, risk factors, and equity sales Item 1. Legal Proceedings The company is not currently a party to any legal proceedings that would have a material effect on its business or results of operations, though it may be involved in various legal actions in the ordinary course of business - The company is not a party to any legal proceedings that would have a material effect on its business or results of operations[128] Item 1A. Risk Factors No material changes to risk factors were disclosed from the Annual Report on Form 10-K, except for an updated risk regarding potential losses from cash accounts due to financial institution failures or marketable securities defaults - No material changes from the risk factors disclosed in the Annual Report on Form 10-K, except for an updated risk concerning financial institution failures[129] - A new risk factor highlights potential losses from cash accounts if financial institutions fail (e.g., Silicon Valley Bank) or from marketable securities if issuers default on obligations[129] - Such events could lead to temporary or permanent loss of access to funds, impacting the company's ability to meet contractual obligations, its financial condition, cash flows, and stock price[129] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities and no material change in the planned use of proceeds from its April 2021 IPO - There were no unregistered sales of equity securities during the period[131] - The company completed its IPO on April 27, 2021, receiving net proceeds of approximately $107.6 million[132] - There has been no material change in the planned use of proceeds from the IPO[133] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - No defaults upon senior securities were reported[134] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable to the company[135] Item 5. Other Information No other information was reported under this item - No other information was reported under this item[136] Item 6. Exhibits This section lists the exhibits filed with the Quarterly Report, including certifications from the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents - The exhibits include certifications of the Principal Executive Officer and Principal Financial Officer (31.1, 31.2, 32.1, 32.2) and various Inline XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[137] Signatures This section contains the official signatures of the company's executive officers, certifying the accuracy and completeness of the report Report Signatures The Quarterly Report is duly signed on behalf of Treace Medical Concepts, Inc. by John T. Treace, Chief Executive Officer and Director, and Mark L. Hair, Chief Financial Officer, on May 9, 2023 - The report was signed by John T. Treace, Chief Executive Officer and Director, and Mark L. Hair, Chief Financial Officer, on May 9, 2023[142]