Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 03, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-39130 | |
Entity Registrant Name | TELA Bio, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 45-5320061 | |
Entity Address, Address Line One | 1 Great Valley Parkway, Suite 24 | |
Entity Address, City or Town | Malvern | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19355 | |
City Area Code | 484 | |
Local Phone Number | 320-2930 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | TELA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,713,798 | |
Entity Central Index Key | 0001561921 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 26,496 | $ 46,729 |
Accounts receivable, net of allowances of $303 and $416 | 9,097 | 9,737 |
Inventory | 13,372 | 13,162 |
Prepaid expenses and other assets | 2,144 | 2,098 |
Total current assets | 51,109 | 71,726 |
Property and equipment, net | 2,349 | 1,984 |
Intangible assets, net | 1,929 | 2,119 |
Right-of-use assets | 1,851 | 1,954 |
Other long-term assets | 2,701 | |
Restricted cash | 265 | 265 |
Total assets | 60,204 | 78,048 |
Current liabilities: | ||
Accounts payable | 2,314 | 1,667 |
Accrued expenses and other current liabilities | 12,675 | 15,300 |
Total current liabilities | 14,989 | 16,967 |
Long-term debt | 40,817 | 40,515 |
Other long-term liabilities | 1,528 | 1,685 |
Total liabilities | 57,334 | 59,167 |
Stockholders' equity: | ||
Preferred stock; $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock; $0.001 par value: 200,000,000 shares authorized; 24,653,939 and 24,494,675 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 25 | 24 |
Additional paid-in capital | 341,897 | 339,655 |
Accumulated other comprehensive income | 98 | 91 |
Accumulated deficit | (339,150) | (320,889) |
Total stockholders' equity | 2,870 | 18,881 |
Total liabilities and stockholders' equity | $ 60,204 | $ 78,048 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Consolidated Balance Sheets | ||
Accounts receivable, Allowance | $ 298 | $ 416 |
Preferred stock, Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, Par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 24,675,832 | 24,494,675 |
Common stock, shares outstanding (in shares) | 24,675,832 | 24,494,675 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Consolidated Statements of Operations and Comprehensive Loss | ||||
Revenue | $ 16,091 | $ 14,494 | $ 32,694 | $ 26,403 |
Cost of revenue (excluding amortization of intangible assets) | 4,923 | 4,198 | 10,095 | 8,114 |
Amortization of intangible assets | 95 | 95 | 190 | 190 |
Gross profit | 11,073 | 10,201 | 22,409 | 18,099 |
Operating expenses: | ||||
Sales and marketing | 16,699 | 14,577 | 34,219 | 28,043 |
General and administrative | 3,621 | 3,472 | 7,450 | 7,106 |
Research and development | 2,323 | 2,514 | 4,716 | 4,566 |
Total operating expenses | 22,643 | 20,563 | 46,385 | 39,715 |
Other operating income: | ||||
Gain on sale of product line | (7,580) | |||
Loss from operations | (11,570) | (10,362) | (16,396) | (21,616) |
Other expense: | ||||
Interest expense | (1,331) | (1,298) | (2,663) | (2,544) |
Other income | 301 | 870 | 798 | 1,343 |
Total other expense | (1,030) | (428) | (1,865) | (1,201) |
Net loss | $ (12,600) | $ (10,790) | $ (18,261) | $ (22,817) |
Net loss per common share, basic | $ (0.51) | $ (0.46) | $ (0.74) | $ (1.08) |
Net loss per common share, diluted | $ (0.51) | $ (0.46) | $ (0.74) | $ (1.08) |
Weighted average common shares outstanding, basic | 24,663,234 | 23,239,262 | 24,621,310 | 21,223,639 |
Weighted average common shares outstanding, diluted | 24,663,234 | 23,239,262 | 24,621,310 | 21,223,639 |
Comprehensive loss: | ||||
Net loss | $ (12,600) | $ (10,790) | $ (18,261) | $ (22,817) |
Foreign currency translation adjustment | 1 | (36) | 7 | (66) |
Comprehensive loss | $ (12,599) | $ (10,826) | $ (18,254) | $ (22,883) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common stock | Additional paid-in capital | Accumulated other comprehensive income | Accumulated deficit | Total |
Balance at Beginning of period at Dec. 31, 2022 | $ 19 | $ 288,361 | $ 150 | $ (274,225) | $ 14,305 |
Balance at Beginning of period (in shares) at Dec. 31, 2022 | 19,165,027 | ||||
Vesting of restricted stock units and exercise of stock options | 100 | 100 | |||
Vesting of restricted stock units and exercise of stock options (in shares) | 117,238 | ||||
Shares withheld for employee taxes | (280) | (280) | |||
Shares withheld for employee taxes (in shares) | (25,951) | ||||
Foreign currency translation adjustment | (66) | (66) | |||
Stock-based compensation expense | 2,422 | 2,422 | |||
Sale of common stock, net of underwriting discounts, commissions and offering costs | $ 5 | 46,336 | 46,341 | ||
Sale of common stock, net of underwriting discounts, commissions and offering costs (in shares) | 5,219,190 | ||||
Net loss | (22,817) | (22,817) | |||
Balance at Ending period at Jun. 30, 2023 | $ 24 | 336,939 | 84 | (297,042) | 40,005 |
Balance at Ending period (in shares) at Jun. 30, 2023 | 24,475,504 | ||||
Balance at Beginning of period at Mar. 31, 2023 | $ 19 | 289,254 | 120 | (286,252) | 3,141 |
Balance at Beginning of period (in shares) at Mar. 31, 2023 | 19,227,777 | ||||
Vesting of restricted stock units and exercise of stock options | 56 | 56 | |||
Vesting of restricted stock units and exercise of stock options (in shares) | 28,650 | ||||
Shares withheld for employee taxes | (1) | (1) | |||
Shares withheld for employee taxes (in shares) | (113) | ||||
Foreign currency translation adjustment | (36) | (36) | |||
Stock-based compensation expense | 1,294 | 1,294 | |||
Sale of common stock, net of underwriting discounts, commissions and offering costs | $ 5 | 46,336 | 46,341 | ||
Sale of common stock, net of underwriting discounts, commissions and offering costs (in shares) | 5,219,190 | ||||
Net loss | (10,790) | (10,790) | |||
Balance at Ending period at Jun. 30, 2023 | $ 24 | 336,939 | 84 | (297,042) | 40,005 |
Balance at Ending period (in shares) at Jun. 30, 2023 | 24,475,504 | ||||
Balance at Beginning of period at Dec. 31, 2023 | $ 24 | 339,655 | 91 | (320,889) | 18,881 |
Balance at Beginning of period (in shares) at Dec. 31, 2023 | 24,494,675 | ||||
Vesting of restricted stock units and exercise of stock options | $ 1 | 225 | 226 | ||
Vesting of restricted stock units and exercise of stock options (in shares) | 202,565 | ||||
Issuance of common stock under the employee stock purchase plan | 164 | 164 | |||
Issuance of common stock under the employee stock purchase plan (in shares) | 27,969 | ||||
Shares withheld for employee taxes | (339) | (339) | |||
Shares withheld for employee taxes (in shares) | (49,377) | ||||
Foreign currency translation adjustment | 7 | 7 | |||
Stock-based compensation expense | 2,192 | 2,192 | |||
Net loss | (18,261) | (18,261) | |||
Balance at Ending period at Jun. 30, 2024 | $ 25 | 341,897 | 98 | (339,150) | 2,870 |
Balance at Ending period (in shares) at Jun. 30, 2024 | 24,675,832 | ||||
Balance at Beginning of period at Mar. 31, 2024 | $ 25 | 340,812 | 97 | (326,550) | 14,384 |
Balance at Beginning of period (in shares) at Mar. 31, 2024 | 24,653,939 | ||||
Vesting of restricted stock units and exercise of stock options | 6 | 6 | |||
Vesting of restricted stock units and exercise of stock options (in shares) | 24,332 | ||||
Shares withheld for employee taxes | (11) | (11) | |||
Shares withheld for employee taxes (in shares) | (2,439) | ||||
Foreign currency translation adjustment | 1 | 1 | |||
Stock-based compensation expense | 1,090 | 1,090 | |||
Net loss | (12,600) | (12,600) | |||
Balance at Ending period at Jun. 30, 2024 | $ 25 | $ 341,897 | $ 98 | $ (339,150) | $ 2,870 |
Balance at Ending period (in shares) at Jun. 30, 2024 | 24,675,832 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (18,261) | $ (22,817) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 293 | 239 |
Noncash interest expense | 302 | 296 |
Amortization of intangible assets | 190 | 190 |
Net changes in operating lease ROU assets and liabilities | (47) | (22) |
Inventory excess and obsolescence charge | 908 | 704 |
Stock-based compensation expense | 2,192 | 2,422 |
Gain on sale of product line | (7,580) | |
Change in operating assets and liabilities: | ||
Accounts receivable, net | 263 | (1,219) |
Inventory | (1,545) | (2,936) |
Prepaid expenses and other current assets | 253 | 107 |
Accounts payable | 594 | 651 |
Accrued expenses and other current and long-term liabilities | (2,627) | (104) |
Foreign currency translation loss | (16) | (349) |
Net cash used in operating activities | (25,081) | (22,838) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (603) | (272) |
Proceeds from the sale of product line | 5,366 | |
Net cash provided by (used in) investing activities | 4,763 | (272) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock, net of underwriting discounts, commissions and offering costs | 46,354 | |
Proceeds from exercise of stock options | 226 | 100 |
Payment of withholding taxes related to stock-based compensation to employees | (339) | (280) |
Proceeds from issuance of common stock under the employee stock purchase plan | 164 | |
Net cash provided by financing activities | 51 | 46,174 |
Effect of exchange rate on cash and cash equivalents | 34 | 183 |
Net (decrease) increase in cash and cash equivalents and restricted cash | (20,233) | 23,247 |
Cash and cash equivalents and restricted cash, beginning of period | 46,994 | 42,019 |
Cash and cash equivalents and restricted cash, end of period | 26,761 | 65,266 |
Supplemental disclosure of cash flow information: | ||
Cash paid during the period for interest | 2,361 | 2,248 |
Supplemental disclosures of noncash investing and financing activities: | ||
Offering costs in accounts payable and accrued expenses and other current liabilities | 13 | |
Property and equipment in accounts payable and accrued expenses and other current liabilities | $ 55 | $ 49 |
Background
Background | 6 Months Ended |
Jun. 30, 2024 | |
Background | |
Background | (1) Background TELA Bio, Inc. (the “Company”) was incorporated in the state of Delaware on April 17, 2012 and wholly owns TELA Bio Limited, a company incorporated in the United Kingdom. The Company is a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy. OviTex Reinforced Tissue Matrix (“OviTex”), the Company’s first portfolio of products, addresses unmet needs in hernia repair and abdominal wall reconstruction by combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings, at a cost-effective price. OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), the Company’s second portfolio of products, addresses unmet needs in plastic and reconstructive surgery. The Company’s principal corporate office and research facility is located in Malvern, Pennsylvania. |
Risks and Liquidity
Risks and Liquidity | 6 Months Ended |
Jun. 30, 2024 | |
Risks and Liquidity | |
Risks and Liquidity | (2) Risks and Liquidity The Company’s operations to date have focused on commercializing products, developing and acquiring technology and assets, business planning, raising capital and organization and staffing. The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $339.2 million as of June 30, 2024. The Company anticipates incurring additional losses until such time, if ever, it can generate sufficient revenue from its products to cover its expenses. In March 2024, the Company sold its distribution rights for NIVIS Fibrillar Collagen Pack to MiMedx Group, Inc. in exchange for an initial $5.0 million payment and additional future payments aggregating between a minimum of $3.0 million and a maximum of $7.0 million based on net sales of NIVIS during the first two years following its launch by MiMedx Group, Inc. The operations of the Company are subject to certain risks and uncertainties including, among others, the uncertainty of product development, the impact of macroeconomic conditions, including any lingering effects of the COVID-19 pandemic or other public health crises, general economic uncertainty, including as a result of inflationary pressures and the measures undertaken by various governments to address them, banking instability, monetary policy changes, geopolitical factors such as the ongoing Russia-Ukraine conflict, the current conflict in Israel and Gaza (including any escalation or expansion) and increasing tensions between China and Taiwan, cybersecurity events affecting or disrupting normal hospital operations, technological uncertainty, commercial acceptance of any developed products, alternative competing technologies, dependence on collaborative partners, uncertainty regarding patents and proprietary rights, comprehensive government regulations, and dependence on key personnel. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | (3) Summary of Significant Accounting Policies The Company’s complete summary of significant accounting policies can be found in “Note 3, Summary of Significant Accounting Policies” in the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Any reference in these notes to applicable guidance is meant to refer to generally accepted accounting principles (“GAAP”) in the U.S. as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) promulgated by the Financial Accounting Standards Board (“FASB”). Interim Financial Statements The accompanying unaudited interim consolidated financial statements have been prepared from the books and records of the Company in accordance with GAAP for interim financial information and Rule 10-01 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”), which permits reduced disclosures for interim periods. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying consolidated balance sheets and statements of operations and comprehensive loss, stockholders’ equity and cash flows have been made. Although these interim consolidated financial statements do not include all of the information and footnotes required for complete annual consolidated financial statements, management believes the disclosures are adequate to make the information presented not misleading. The unaudited interim results of operations and cash flows are not necessarily indicative of the results that may be expected for the full year. The unaudited interim consolidated financial statements and footnotes should be read in conjunction with the consolidated financial statements and footnotes included in the Annual Report on Form 10-K for the year ended December 31, 2023. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. The most significant judgments are employed in estimates used to determine the recoverability of the carrying value of the Company’s inventory. As future events and their effects cannot be determined with precision, actual results may differ significantly from these estimates. Revenue Recognition Under ASC Topic 606, Revenue from Contracts with Customers A significant portion of the Company’s revenue is generated from product shipped to a customer or from consigned inventory maintained at hospitals or other surgical facilities. Revenue from the sale of consigned products is recognized when control is transferred to the customer, which occurs at the time the product is used in a surgical procedure. For product that is not held on consignment, the Company recognizes revenue when control transfers to the customer which occurs at the time the product is shipped or delivered. For all of the Company’s customer contracts, the only identified performance obligation is providing the product to the customer. Revenue is recognized at the estimated net sales price, which includes estimates of variable consideration. The Company enters into contracts with certain third-party payors for the payment of rebates with respect to the utilization of its products. These rebates are based on contractual percentages. The Company estimates and records these rebates in the same period the related revenue is recognized, resulting in a reduction of product revenue. Payment terms with customers do not exceed one year and, therefore, the Company does not account for a financing component in these arrangements. There are no incremental costs of obtaining a contract that would rise to or enhance an asset other than product costs, which are a component of inventory. The Company expenses incremental costs of obtaining a contract with a customer (e.g., sales commissions) when incurred as the period of benefit is less than one year. Fees charged to customers for shipping are recognized as revenue. The following table presents revenue disaggregated by the Company’s portfolio of products (in thousands): Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 OviTex $ 11,124 $ 10,058 $ 21,659 $ 18,081 OviTex PRS 4,796 4,390 10,741 8,251 Other 171 46 294 71 Total revenue $ 16,091 $ 14,494 $ 32,694 $ 26,403 Sales outside of the U.S. were $2.4 million and $1.5 million, respectively, for the three months ended June 30, 2024 and 2023 and $4.7 million and $2.5 million, respectively, for the six months ended June 30, 2024 and 2023. Fair Value of Financial Instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction among market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments are made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, other assets, and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The carrying amounts of the Company’s Credit and Security Agreement approximates fair value due to its variable interest rate. The Company follows the provisions of ASC Topic 820, Fair Value Measurement ● Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. ● Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liabilities. ● Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair value measurement at reporting date using Quoted prices in active markets Significant other Significant for identical observable unobservable assets inputs inputs (Level 1) (Level 2) (Level 3) June 30, 2024: Cash equivalents – money market fund $ 24,498 $ — $ — December 31, 2023: Cash equivalents – money market fund $ 41,561 $ — $ — Net Loss per Common Share Basic and diluted net loss per common share is determined by dividing net loss by the weighted-average shares of common stock outstanding during the reporting period. In periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share since dilutive shares are not assumed to have been issued if their effect is antidilutive. Therefore, the weighted-average shares used to calculate both basic and diluted net loss per share are the same. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding for the periods presented, as they would be antidilutive. Six months ended June 30, 2024 2023 Stock options 2,239,140 2,218,832 Unvested restricted stock units 991,391 781,011 Common stock warrants 88,556 88,556 Total 3,319,087 3,088,399 Recently Issued Accounting Pronouncements The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options and Derivatives and Hedging - Contracts in Entity’s Own Equity (“ . In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures some categories if the items meet a quantitative threshold. This guidance is effective for annual periods beginning after December 15, 2024, and should be applied prospectively, but entities have the option to apply it retrospectively for each period presented. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the expected impact that the standard could have on its consolidated financial statements and related disclosures. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | (4) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, December 31, 2024 2023 Compensation and related benefits $ 6,609 $ 9,216 Third-party and professional fees 2,685 2,828 Amounts due to contract manufacturer 1,945 2,024 Current portion of operating lease liabilities 571 565 Research and development expenses 99 140 Other 766 527 Total accrued expenses and other current liabilities $ 12,675 $ 15,300 |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt | |
Debt | (5) Long-term Debt Long-term debt consisted of the following (in thousands): June 30, December 31, 2024 2023 MidCap term loan $ 40,000 $ 40,000 End of term charge 2,000 2,000 Unamortized end of term charge and issuance costs (1,183) (1,485) Long-term debt $ 40,817 $ 40,515 MidCap Term Loan On May 26, 2022, the Company entered into the Credit and Security Agreement (the “MidCap Credit Agreement”) with MidCap Financial Trust, as agent, and certain lender parties thereto. The MidCap Credit Agreement consists of $40.0 million in a term loan. Upon closing, the Company used a portion of the proceeds to repay borrowings under a previous credit facility and intends to use the remaining proceeds to fund operations and other general corporate purposes. Pursuant to the MidCap Credit Agreement, the Company provided a first priority security interest in all existing and future acquired assets, including intellectual property, owned by the Company. The MidCap Credit Agreement contains certain covenants that limit the Company’s ability to engage in certain transactions that may be in the Company’s long-term best interests, including the incurrence of additional indebtedness, effecting certain corporate changes, making certain investments, acquisitions or dispositions and paying dividends. The MidCap Credit Agreement also contains customary indemnification obligations and customary events of default, including, among other things, (i) non-payment, (ii) breach of warranty, (iii) non-performance of covenants and obligations, (iv) default on other indebtedness, (v) judgments, (vi) change of control, (vii) bankruptcy and insolvency, (viii) impairment of security, (ix) key permit events, (x) termination of a pension plan, (xi) regulatory matters, (xii) material adverse effect and (xiii) breach of material contracts. In addition, the Company must maintain minimum net revenue levels tested quarterly. In the event of default under the MidCap Credit Agreement, the Company would be required to pay interest on principal and all other due and unpaid obligations at the current rate in effect plus 2%. The MidCap term loan matures on May 1, 2027 and bears interest at a rate equal to 6.25% plus the greater of one-month Term SOFR Subject to certain limitations, the MidCap term loan has a prepayment fee equal to 3.0% of the prepaid principal amount for the first year following the closing date of the MidCap term loan, 2.0% of the prepaid principal amount for the second year following the closing date and 1.0% of the prepaid principal amount for the third year following the closing date and thereafter. The Company is also required to pay an exit fee at the time of maturity or prepayment event equal to 5% of all principal borrowings (the “End of Term Charge”) (or in the event of a prepayment event, the amount of principal being prepaid). Interest expense associated with the MidCap Credit Facility recorded for the three and six months ended June 30, 2024 was $1.3 million and $2.7 million, respectively, of which $0.2 million and $0.3 million, respectively, was related to the amortization of debt issuance costs. Interest expense associated with the MidCap Credit Facility recorded for the three and six months ended June 30, 2023 was $1.3 million and $2.5 million, respectively, of which $0.2 million and $0.3 million, respectively, was related to the amortization of debt issuance costs. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity | |
Stockholders' Equity | (6) Stockholders’ Equity In November 2023, the Company entered into an Equity Distribution Agreement (the “2023 Equity Agreement”) with Piper Sandler & Co, (“Piper”) in connection with the establishment of an at-the-market offering program under which the Company may sell shares of its common stock, from time to time through Piper as sales agent, in an initial amount of up to $50.0 million. The 2023 Equity Agreement superseded and replaced the Company’s previous Equity Distribution Agreement with Piper dated December 18, 2020 (the “2020 Equity Agreement”), which is no longer effective. No sales were made under the 2023 Equity Agreement or the 2020 Equity Agreement during the six months ended June 30, 2024 or 2023. Warrants The Company had the following warrants outstanding to purchase common stock at June 30, 2024: Exercise Expiration Outstanding price dates Common stock warrants 8,379 $ 28.65 2028 Common stock warrants 80,177 28.65 2027 88,556 |
Sale of Product Line
Sale of Product Line | 6 Months Ended |
Jun. 30, 2024 | |
Sale of Product Line | |
Sale of Product Line | (7) Sale of Product Line In March 2024, the Company entered into an Asset Purchase Agreement (“APA”) with MiMedx Group, Inc. (“MDXG”) to sell certain assets (the “Transaction”) related to NIVIS Fibrillar Collagen Pack Device (“NIVIS”). These assets mainly included the Company’s existing inventory of NIVIS, with a net carrying value of $0.8 million, and certain intellectual property rights to sell NIVIS, with no carrying value. MDXG assumed the Company’s existing supply agreements, including the minimum obligations for NIVIS that the Company entered into in 2022 ahead of the initial sales of NIVIS. In exchange for entering into the Transaction, the Company received an initial $5.0 million upfront payment and is entitled to receive future revenue-sharing payments based on the net sales of NIVIS during the first two years following its launch by MDXG, which revenue-sharing payments would range from a minimum of $3.0 million to a maximum of $7.0 million in the aggregate. Any consideration in excess of $3.0 million up to $7.0 million is considered variable consideration that is fully constrained. The Company accounted for the Transaction as a sale of a nonfinancial asset group in accordance with ASC 610-20 and followed the principals of ASC 606 to determine the consideration of $8.4 million related to the Transaction. The Company transferred control of the nonfinancial asset group in March 2024 and recognized a gain of $7.6 million on the consolidated statement of operations and comprehensive loss during the three months ended March 31, 2024. Additionally, the Company recorded the minimum revenue-share payment of $3.0 million as a receivable at June 30, 2024, with $0.3 million representing the current portion in prepaid expenses and other assets in the consolidated balance sheet and $2.7 million representing the long-term portion in other long-term assets in the consolidated balance sheet. At each reporting date, the Company assesses the constraint of variable consideration and records increases in the transaction price in the period that the estimate of variable consideration changes. For the three and six months ended June 30, 2024, no changes were made to the variable consideration. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | (8) Stock-Based Compensation The Company has two equity incentive plans: the 2012 Stock Incentive Plan and the Amended and Restated 2019 Equity Incentive Plan. New awards can only be granted under the Amended and Restated 2019 Equity Incentive Plan (the “Plan”). At June 30, 2024, 806,609 shares of common stock were available for future issuances under the Plan. The Plan is subject to an annual increase, subject to prior approval by the Company’s board of directors, equal to the lesser of (i) 432,442 shares, (ii) 4% of the shares outstanding on the last day of the immediately preceding fiscal year and (iii) such smaller number of shares as determined by the board of directors. The Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock awards, restricted stock units and/or stock appreciation rights to employees, directors, and other persons, as determined by the Company’s board of directors. The Company estimates forfeitures that it expects will occur and adjusts expense for actual forfeitures in the periods they occur. The Company measures employee and nonemployee stock-based awards at grant-date fair value and records compensation expense ratably over the vesting period of the award. The Company recorded stock-based compensation expense in the following expense categories of the accompanying consolidated statements of operations and comprehensive loss (in thousands): Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Sales and marketing $ 302 $ 467 $ 675 $ 868 General and administrative 624 637 1,197 1,191 Research and development 164 190 320 363 Total stock‑based compensation $ 1,090 $ 1,294 $ 2,192 $ 2,422 Stock Options The Company’s stock options vest based on the terms in each award agreement and generally vest over four years and have a term of 10 years. The following table summarizes stock option activity: Weighted average Weighted remaining Number of average exercise contractual term shares price per share (years) Outstanding at January 1, 2024 2,162,453 $ 11.48 Granted 259,900 6.86 Exercised (38,431) 5.88 Canceled/forfeited (144,782) 11.07 Outstanding at June 30, 2024 2,239,140 $ 11.07 6.11 Vested and expected to vest at June 30, 2024 2,202,926 $ 11.10 6.06 Exercisable at June 30, 2024 1,667,647 $ 11.60 5.24 Included in outstanding options at June 30, 2024 were 334,907 stock options granted outside of the Plan. These grants were made pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq listing rule 5635(c)(4). At June 30, 2024, the aggregate intrinsic value of both outstanding options and exercisable options was immaterial. The weighted average grant-date fair value per share of options granted was $4.67 during the six months ended June 30, 2024. The aggregate intrinsic value of options exercised was immaterial and $41,000 for the three and six months ended June 30, 2024, respectively. At June 30, 2024, the total unrecognized compensation expense related to unvested employee and nonemployee stock option awards was $3.2 million, which is expected to be recognized in expense over a weighted-average period of approximately 2.3 years. Estimating Fair Value of Stock Options The fair value of each grant of stock options was determined by the Company using the methods and assumptions discussed below. Certain of these inputs are subjective and generally require judgment to determine. Expected term Expected volatility Risk-free interest rate Expected dividend The fair value of each option was estimated on the date of grant using the Black-Scholes option pricing model and the weighted average assumptions in the table below: Six months ended June 30, 2024 Expected dividend yield — Expected volatility 73.2 % Risk‑free interest rate 4.29 % Expected term (in years) 6.14 Restricted Stock Units The Company has issued service-based and performance-based restricted stock units (“RSUs”). Vesting of the service-based RSUs is based on the terms in each award agreement and is generally over four years. Vesting of the performance-based RSUs is subject to continued service through 2026 and the achievement of certain performance milestones for fiscal year 2026. The amount of performance-based RSUs that will vest can range from 0% to 110% of the original number of RSUs granted. Expense for the performance-based RSUs is not recognized until the performance conditions are deemed probable of achievement. The Company has not recorded any expense related to the performance-based RSUs. The following table summarizes the service-based RSUs for the Plan: Number of shares Outstanding at January 1, 2024 657,054 Granted 393,425 Vested (164,134) Canceled/forfeited (111,454) Outstanding at June 30, 2024 774,891 The following table summarizes the performance-based RSUs for the Plan: Number of shares Outstanding at January 1, 2024 250,149 Granted — Vested — Canceled/forfeited (33,649) Outstanding at June 30, 2024 216,500 Included in outstanding RSUs at June 30, 2024 were 122,949 RSUs granted outside of the Plan. These grants were made pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq listing rule 5635(c)(4). The weighted average grant-date fair value per RSU granted was $6.74 during the six months ended June 30, 2024. The aggregate intrinsic value of RSUs outstanding was $4.7 million at June 30, 2024. The total unrecognized compensation expense at June 30, 2024 related to RSUs was $5.3 million, which is expected to be recognized in expense over a weighted-average period of approximately 2.9 years. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (12,600) | $ (10,790) | $ (18,261) | $ (22,817) |
Insider Trading Arrangements
Insider Trading Arrangements | 6 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Interim Financial Statements | Interim Financial Statements The accompanying unaudited interim consolidated financial statements have been prepared from the books and records of the Company in accordance with GAAP for interim financial information and Rule 10-01 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”), which permits reduced disclosures for interim periods. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying consolidated balance sheets and statements of operations and comprehensive loss, stockholders’ equity and cash flows have been made. Although these interim consolidated financial statements do not include all of the information and footnotes required for complete annual consolidated financial statements, management believes the disclosures are adequate to make the information presented not misleading. The unaudited interim results of operations and cash flows are not necessarily indicative of the results that may be expected for the full year. The unaudited interim consolidated financial statements and footnotes should be read in conjunction with the consolidated financial statements and footnotes included in the Annual Report on Form 10-K for the year ended December 31, 2023. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. The most significant judgments are employed in estimates used to determine the recoverability of the carrying value of the Company’s inventory. As future events and their effects cannot be determined with precision, actual results may differ significantly from these estimates. |
Revenue Recognition | Revenue Recognition Under ASC Topic 606, Revenue from Contracts with Customers A significant portion of the Company’s revenue is generated from product shipped to a customer or from consigned inventory maintained at hospitals or other surgical facilities. Revenue from the sale of consigned products is recognized when control is transferred to the customer, which occurs at the time the product is used in a surgical procedure. For product that is not held on consignment, the Company recognizes revenue when control transfers to the customer which occurs at the time the product is shipped or delivered. For all of the Company’s customer contracts, the only identified performance obligation is providing the product to the customer. Revenue is recognized at the estimated net sales price, which includes estimates of variable consideration. The Company enters into contracts with certain third-party payors for the payment of rebates with respect to the utilization of its products. These rebates are based on contractual percentages. The Company estimates and records these rebates in the same period the related revenue is recognized, resulting in a reduction of product revenue. Payment terms with customers do not exceed one year and, therefore, the Company does not account for a financing component in these arrangements. There are no incremental costs of obtaining a contract that would rise to or enhance an asset other than product costs, which are a component of inventory. The Company expenses incremental costs of obtaining a contract with a customer (e.g., sales commissions) when incurred as the period of benefit is less than one year. Fees charged to customers for shipping are recognized as revenue. The following table presents revenue disaggregated by the Company’s portfolio of products (in thousands): Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 OviTex $ 11,124 $ 10,058 $ 21,659 $ 18,081 OviTex PRS 4,796 4,390 10,741 8,251 Other 171 46 294 71 Total revenue $ 16,091 $ 14,494 $ 32,694 $ 26,403 Sales outside of the U.S. were $2.4 million and $1.5 million, respectively, for the three months ended June 30, 2024 and 2023 and $4.7 million and $2.5 million, respectively, for the six months ended June 30, 2024 and 2023. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction among market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments are made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, other assets, and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The carrying amounts of the Company’s Credit and Security Agreement approximates fair value due to its variable interest rate. The Company follows the provisions of ASC Topic 820, Fair Value Measurement ● Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. ● Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liabilities. ● Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair value measurement at reporting date using Quoted prices in active markets Significant other Significant for identical observable unobservable assets inputs inputs (Level 1) (Level 2) (Level 3) June 30, 2024: Cash equivalents – money market fund $ 24,498 $ — $ — December 31, 2023: Cash equivalents – money market fund $ 41,561 $ — $ — |
Net Loss per Common Share | Net Loss per Common Share Basic and diluted net loss per common share is determined by dividing net loss by the weighted-average shares of common stock outstanding during the reporting period. In periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share since dilutive shares are not assumed to have been issued if their effect is antidilutive. Therefore, the weighted-average shares used to calculate both basic and diluted net loss per share are the same. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding for the periods presented, as they would be antidilutive. Six months ended June 30, 2024 2023 Stock options 2,239,140 2,218,832 Unvested restricted stock units 991,391 781,011 Common stock warrants 88,556 88,556 Total 3,319,087 3,088,399 |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options and Derivatives and Hedging - Contracts in Entity’s Own Equity (“ . In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures some categories if the items meet a quantitative threshold. This guidance is effective for annual periods beginning after December 15, 2024, and should be applied prospectively, but entities have the option to apply it retrospectively for each period presented. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the expected impact that the standard could have on its consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Disaggregation of Revenue | The following table presents revenue disaggregated by the Company’s portfolio of products (in thousands): Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 OviTex $ 11,124 $ 10,058 $ 21,659 $ 18,081 OviTex PRS 4,796 4,390 10,741 8,251 Other 171 46 294 71 Total revenue $ 16,091 $ 14,494 $ 32,694 $ 26,403 |
Schedule of fair value of assets and liabilities measured on recurring basis | The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair value measurement at reporting date using Quoted prices in active markets Significant other Significant for identical observable unobservable assets inputs inputs (Level 1) (Level 2) (Level 3) June 30, 2024: Cash equivalents – money market fund $ 24,498 $ — $ — December 31, 2023: Cash equivalents – money market fund $ 41,561 $ — $ — |
Schedule of dilutive securities excluded | Six months ended June 30, 2024 2023 Stock options 2,239,140 2,218,832 Unvested restricted stock units 991,391 781,011 Common stock warrants 88,556 88,556 Total 3,319,087 3,088,399 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, December 31, 2024 2023 Compensation and related benefits $ 6,609 $ 9,216 Third-party and professional fees 2,685 2,828 Amounts due to contract manufacturer 1,945 2,024 Current portion of operating lease liabilities 571 565 Research and development expenses 99 140 Other 766 527 Total accrued expenses and other current liabilities $ 12,675 $ 15,300 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt | |
Schedule of long term debt | Long-term debt consisted of the following (in thousands): June 30, December 31, 2024 2023 MidCap term loan $ 40,000 $ 40,000 End of term charge 2,000 2,000 Unamortized end of term charge and issuance costs (1,183) (1,485) Long-term debt $ 40,817 $ 40,515 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity | |
Schedule of warrants outstanding to purchase common stock | Exercise Expiration Outstanding price dates Common stock warrants 8,379 $ 28.65 2028 Common stock warrants 80,177 28.65 2027 88,556 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stock-Based Compensation | |
Schedule of stock based compensation expense categories in statement of operations | Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Sales and marketing $ 302 $ 467 $ 675 $ 868 General and administrative 624 637 1,197 1,191 Research and development 164 190 320 363 Total stock‑based compensation $ 1,090 $ 1,294 $ 2,192 $ 2,422 |
Schedule of stock option activity | Weighted average Weighted remaining Number of average exercise contractual term shares price per share (years) Outstanding at January 1, 2024 2,162,453 $ 11.48 Granted 259,900 6.86 Exercised (38,431) 5.88 Canceled/forfeited (144,782) 11.07 Outstanding at June 30, 2024 2,239,140 $ 11.07 6.11 Vested and expected to vest at June 30, 2024 2,202,926 $ 11.10 6.06 Exercisable at June 30, 2024 1,667,647 $ 11.60 5.24 |
Schedule of weighted average assumptions | Six months ended June 30, 2024 Expected dividend yield — Expected volatility 73.2 % Risk‑free interest rate 4.29 % Expected term (in years) 6.14 |
Schedule of restricted stock units (RSUs) | Number of shares Outstanding at January 1, 2024 657,054 Granted 393,425 Vested (164,134) Canceled/forfeited (111,454) Outstanding at June 30, 2024 774,891 |
Schedule of performance-based (RSUs) | Number of shares Outstanding at January 1, 2024 250,149 Granted — Vested — Canceled/forfeited (33,649) Outstanding at June 30, 2024 216,500 |
Risks and Liquidity (Details)
Risks and Liquidity (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Unusual Risk or Uncertainty [Line Items] | |||
Accumulated deficit | $ (339,150) | $ (320,889) | |
Proceeds from the sale of product line | 5,366 | ||
Received net proceeds of after deducting underwriting discounts, commissions and other offering expenses | $ 46,354 | ||
MiMedx Group, Inc. | |||
Unusual Risk or Uncertainty [Line Items] | |||
Proceeds from the sale of product line | $ 5,000 | ||
Period of net sales considered for calculating additional future payment receivable | 2 years | ||
MiMedx Group, Inc. | Maximum | |||
Unusual Risk or Uncertainty [Line Items] | |||
Revenue sharing payments | $ 7,000 | ||
MiMedx Group, Inc. | Minimum | |||
Unusual Risk or Uncertainty [Line Items] | |||
Revenue sharing payments | $ 3,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Revenue Disaggregated (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 16,091 | $ 14,494 | $ 32,694 | $ 26,403 |
Incremental costs of obtaining a contract | 0 | |||
Non-US [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 2,400 | 1,500 | 4,700 | 2,500 |
OviTex | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 11,124 | 10,058 | 21,659 | 18,081 |
OviTex PRS | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 4,796 | 4,390 | 10,741 | 8,251 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 171 | $ 46 | $ 294 | $ 71 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Recurring | Level 1 | Money market funds | ||
Fair Value of Financial Instruments | ||
Cash equivalents | $ 24,498 | $ 41,561 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Net Loss per Common Share (Potentially dilutive securities) (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Potentially dilutive securities | ||
Potentially dilutive securities excluded from computation of diluted weighted average shares | 3,319,087 | 3,088,399 |
Employee Stock Option | ||
Potentially dilutive securities | ||
Potentially dilutive securities excluded from computation of diluted weighted average shares | 2,239,140 | 2,218,832 |
Unvested restricted stock units | ||
Potentially dilutive securities | ||
Potentially dilutive securities excluded from computation of diluted weighted average shares | 991,391 | 781,011 |
Common Stock Warrants | ||
Potentially dilutive securities | ||
Potentially dilutive securities excluded from computation of diluted weighted average shares | 88,556 | 88,556 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Expenses and Other Current Liabilities | ||
Compensation and related benefits | $ 6,609 | $ 9,216 |
Third-party and professional fees | 2,685 | 2,828 |
Amounts due to contract manufacturer | 1,945 | 2,024 |
Current portion of operating lease liabilities | $ 571 | $ 565 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total accrued expenses and other current liabilities | Total accrued expenses and other current liabilities |
Research and development expenses | $ 99 | $ 140 |
Other | 766 | 527 |
Total accrued expenses and other current liabilities | $ 12,675 | $ 15,300 |
Long-term Debt - Schedule of lo
Long-term Debt - Schedule of long term debt (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | May 26, 2022 |
Long term Debt | |||
End of term charge | $ 2,000 | $ 2,000 | |
Unamortized end of term charge and issuance costs | (1,183) | (1,485) | |
Long-term debt | 40,817 | 40,515 | |
MidCap term loan | |||
Long term Debt | |||
MidCap term loan | $ 40,000 | $ 40,000 | $ 40,000 |
Long-term Debt - MidCap Term Lo
Long-term Debt - MidCap Term Loan (Details) - MidCap term loan - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | May 26, 2022 | |
Long term Debt | ||||||
Debt amount | $ 40,000 | $ 40,000 | $ 40,000 | $ 40,000 | ||
Interest due to unpaid obligation | 2% | |||||
Interest Rate (as a percent) | 6.25% | 6.25% | ||||
Variable Interest Rate (as a percent) | 1% | |||||
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration] | us-gaap:SecuredOvernightFinancingRateSofrOvernightIndexSwapRateMember | |||||
Interest-Only Period | 36 months | |||||
Exit fee (as a percent) | 5% | |||||
Interest expenses | $ 1,300 | $ 1,300 | $ 2,700 | $ 2,500 | ||
Amortization of debt issuance costs | $ 200 | $ 200 | $ 300 | $ 300 | ||
Maximum | ||||||
Long term Debt | ||||||
Extension for interest only payment period | 48 months | |||||
Minimum | ||||||
Long term Debt | ||||||
Extension for interest only payment period | 12 months | |||||
First year | ||||||
Long term Debt | ||||||
Percentage of prepayment penalty on prepaid principal amount | 3% | |||||
Second year | ||||||
Long term Debt | ||||||
Percentage of prepayment penalty on prepaid principal amount | 2% | |||||
Third year | ||||||
Long term Debt | ||||||
Percentage of prepayment penalty on prepaid principal amount | 1% |
Stockholders' Equity - Public S
Stockholders' Equity - Public Stock Offerings (Details) - USD ($) $ in Thousands | 6 Months Ended | 18 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2024 | Nov. 30, 2023 | |
Stockholders' Equity | |||
Received net proceeds of after deducting underwriting discounts, commissions and other offering expenses | $ 46,354 | ||
Equity Distribution Agreement | |||
Stockholders' Equity | |||
Common Stock Available Under ATM | $ 50,000 | ||
Value Of Shares Sold Under Equity Distribution Agreement | $ 0 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants outstanding (Details) | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Stockholders' Equity | |
Warrants outstanding | 88,556 |
Common stock warrants expiring in 2028 | |
Stockholders' Equity | |
Warrants outstanding | 8,379 |
Warrants exercise price | $ / shares | $ 28.65 |
Expiration dates | 2028 |
Common stock warrants expiring in 2027 | |
Stockholders' Equity | |
Warrants outstanding | 80,177 |
Warrants exercise price | $ / shares | $ 28.65 |
Expiration dates | 2027 |
Sale of Product Line - Narrativ
Sale of Product Line - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2024 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Proceeds from the sale of product line | $ 5,366,000 | ||
Gain on sale of product line | 7,580,000 | ||
MiMedx Group, Inc. | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Proceeds from the sale of product line | 5,000,000 | ||
Minimum | MiMedx Group, Inc. | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue sharing payments | $ 3,000,000 | 3,000,000 | |
Maximum | MiMedx Group, Inc. | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue sharing payments | 7,000,000 | 7,000,000 | |
Transaction | MiMedx Group, Inc. | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Amount minimum revenue share payments receivable | 3,000,000 | 3,000,000 | |
Amount minimum revenue share payments receivable current | 300,000 | 300,000 | |
Amount minimum revenue share payments receivable non-current | 2,700,000 | 2,700,000 | |
Variable Consideration | 0 | 0 | |
Transaction | Minimum | MiMedx Group, Inc. | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue sharing payments | 3,000,000 | 3,000,000 | |
Variable consideration | 3,000,000 | 3,000,000 | |
Transaction | Maximum | MiMedx Group, Inc. | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue sharing payments | 7,000,000 | 7,000,000 | |
Variable consideration | 7,000,000 | 7,000,000 | |
Transaction | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | MiMedx Group, Inc. | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Net carrying value | 800,000 | 800,000 | |
Carrying value | 0 | 0 | |
Proceeds from the sale of product line | 5,000,000 | ||
Consideration determined | $ 8,400,000 | $ 8,400,000 | |
Gain on sale of product line | $ 7,600,000 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narratives (Details) | 6 Months Ended |
Jun. 30, 2024 USD ($) item $ / shares shares | |
Stock-Based Compensation | |
Number of equity incentive plans | item | 2 |
Employee Stock Option [Member] | |
Stock-Based Compensation | |
Inducement grants | shares | 334,907 |
Weighted average grant date fair value, Options (per share) | $ / shares | $ 4.67 |
Aggregate intrinsic value of exercised options | $ | $ 41,000 |
Unrecognized compensation expense | $ | $ 3,200,000 |
Weighted average period for recognition of unrecognized expenses | 2 years 3 months 18 days |
Restricted stock units | |
Stock-Based Compensation | |
Inducement grants | shares | 122,949 |
Unrecognized compensation expense | $ | $ 5,300,000 |
Weighted average period for recognition of unrecognized expenses | 2 years 10 months 24 days |
Weighted average grant date fair value, Equity Instruments (per share) | $ / shares | $ 6.74 |
Aggregate intrinsic value | $ | $ 4,700,000 |
Performance based restricted stock units | Minimum | |
Stock-Based Compensation | |
Vest Range | 0% |
Performance based restricted stock units | Maximum | |
Stock-Based Compensation | |
Vest Range | 110% |
Service based restricted stock unit | |
Stock-Based Compensation | |
Vesting period | 4 years |
2019 Equity Incentive Plan | |
Stock-Based Compensation | |
Shares available for future issuance | shares | 806,609 |
Common Stock Capital Shares Reserved For Future Annual Issuance | shares | 432,442 |
Potential common shares outstanding on the last day of the immediately preceding fiscal year | 4% |
2019 Equity Incentive Plan | Employee Stock Option [Member] | |
Stock-Based Compensation | |
Vesting period | 4 years |
Contractual term | 10 years |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock-Based Compensation | ||||
Total stock-based compensation | $ 1,090 | $ 1,294 | $ 2,192 | $ 2,422 |
Sales and marketing | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 302 | 467 | 675 | 868 |
General and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 624 | 637 | 1,197 | 1,191 |
Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | $ 164 | $ 190 | $ 320 | $ 363 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Number of shares | |
Balance at beginning of period | shares | 2,162,453 |
Granted | shares | 259,900 |
Exercised | shares | (38,431) |
Canceled/forfeited | shares | (144,782) |
Balance at end of period | shares | 2,239,140 |
Vested and expected to vest at end of period | shares | 2,202,926 |
Exercisable at end of period | shares | 1,667,647 |
Weighted average exercise price per share | |
Balance at beginning of period (in dollars per share) | $ / shares | $ 11.48 |
Granted ( in dollars per share) | $ / shares | 6.86 |
Exercised (in dollars per share) | $ / shares | 5.88 |
Canceled/forfeited (in dollars per share) | $ / shares | 11.07 |
Balance at end of period (in dollars per share) | $ / shares | 11.07 |
Vested and expected to vest at end of period (in dollars per share) | $ / shares | 11.10 |
Exercisable at end of period (in dollars per share) | $ / shares | $ 11.60 |
Weighted average remaining contractual term (years) | |
Weighted average remaining contractual term, outstanding | 6 years 1 month 9 days |
Weighted average remaining contractual term, Vested and expected to vest | 6 years 21 days |
Weighted average remaining contractual term, Exercisable | 5 years 2 months 26 days |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted average assumptions (Details) | 6 Months Ended |
Jun. 30, 2024 | |
Stock-Based Compensation | |
Expected volatility | 73.20% |
Risk-free interest rate | 4.29% |
Expected term (in years) | 6 years 1 month 20 days |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Units (Details) | 6 Months Ended |
Jun. 30, 2024 shares | |
Service Based Restricted Stock Units [Member] | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Outstanding at beginning of period | 657,054 |
Granted | 393,425 |
Vested | (164,134) |
Canceled/forfeited | (111,454) |
Outstanding at end of period | 774,891 |
Performance Based Restricted Stock Units [Member] | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |
Outstanding at beginning of period | 250,149 |
Canceled/forfeited | (33,649) |
Outstanding at end of period | 216,500 |