Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 01, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36046 | ||
Entity Registrant Name | AXOGEN, INC. | ||
Entity Incorporation, State or Country Code | MN | ||
Entity Tax Identification Number | 41-1301878 | ||
Entity Address, Address Line One | 13631 Progress Blvd., Suite 400 | ||
Entity Address, City or Town | Alachua | ||
Entity Address, State or Province | FL | ||
Entity Address, Postal Zip Code | 32615 | ||
City Area Code | 386 | ||
Local Phone Number | 462-6800 | ||
Title of 12(b) Security | Common Stock, $0.01 par value | ||
Trading Symbol | AXGN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 314,414,758 | ||
Entity Common Stock, Shares Outstanding | 43,206,246 | ||
Documents Incorporated by Reference | Portions of the Registrant’s definitive proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the Registrant’s fiscal year are incorporated by reference into Part III of this Form 10-K. | ||
Entity Central Index Key | 0000805928 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Firm ID | 34 |
Auditor Name | Deloitte & Touche LLP |
Auditor Location | Tampa, Florida |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 31,024 | $ 15,284 |
Restricted cash | 6,002 | 6,251 |
Investments | 0 | 33,505 |
Accounts receivable, net of allowance for doubtful accounts of $337 and $650, respectively | 25,147 | 22,186 |
Inventory | 23,020 | 18,905 |
Prepaid expenses and other | 2,811 | 1,944 |
Total current assets | 88,004 | 98,075 |
Property and equipment, net | 88,730 | 79,294 |
Operating lease right-of-use assets | 15,562 | 14,369 |
Intangible assets, net | 4,531 | 3,649 |
Total assets | 196,827 | 195,387 |
Current liabilities: | ||
Accounts payable and accrued expenses | 28,883 | 22,443 |
Current maturities of long-term lease obligations | 1,547 | 1,310 |
Total current liabilities | 30,430 | 23,753 |
Long-term debt, net of debt discount and financing fees | 46,603 | 45,712 |
Long-term lease obligations | 21,142 | 20,405 |
Debt derivative liabilities | 2,987 | 4,518 |
Total liabilities | 101,162 | 94,388 |
Commitments and contingencies - see Note 14 | ||
Shareholders’ equity: | ||
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 43,124,496 and 42,445,517 shares issued and outstanding | 431 | 424 |
Additional paid-in capital | 376,530 | 360,155 |
Accumulated deficit | (281,296) | (259,580) |
Total shareholders’ equity | 95,665 | 100,999 |
Total liabilities and shareholders’ equity | $ 196,827 | $ 195,387 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Accounts receivable, allowance for doubtful accounts | $ 337 | $ 650 |
Common stock, par value (in USD per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 43,124,496 | 42,445,517 |
Common stock, shares outstanding (in shares) | 43,124,496 | 42,445,517 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | |||
Revenues | $ 159,012 | $ 138,584 | $ 127,358 |
Cost of goods sold | 31,138 | 24,147 | 22,931 |
Gross profit | 127,874 | 114,437 | 104,427 |
Costs and expenses: | |||
Sales and marketing | 86,060 | 80,228 | 73,328 |
Research and development | 28,333 | 27,158 | 24,177 |
General and administrative | 34,943 | 36,758 | 32,338 |
Total costs and expenses | 149,336 | 144,144 | 129,843 |
Loss from operations | (21,462) | (29,707) | (25,416) |
Other (expense) income: | |||
Investment income | 1,487 | 569 | 93 |
Interest expense | (2,835) | (624) | (1,356) |
Change in fair value of derivatives | 1,531 | 1,044 | (28) |
Other expense | (437) | (230) | (278) |
Total other (expense) income, net | (254) | 759 | (1,569) |
Net loss | $ (21,716) | $ (28,948) | $ (26,985) |
Weighted average common shares outstanding - basic (in shares) | 42,878,543 | 42,083,125 | 41,214,889 |
Weighted average common shares outstanding - diluted (in shares) | 42,878,543 | 42,083,125 | 41,214,889 |
Loss per common share - basic (in USD per share) | $ (0.51) | $ (0.69) | $ (0.65) |
Loss per common share - diluted (in USD per share) | $ (0.51) | $ (0.69) | $ (0.65) |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 40,619,000 | |||
Beginning balance at Dec. 31, 2020 | $ 123,149 | $ 406 | $ 326,390 | $ (203,647) |
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation | 10,919 | 10,919 | ||
Issuance of restricted and performance stock units (in shares) | 254,000 | |||
Issuance of restricted and performance stock units | 0 | $ 2 | (2) | |
Shares surrendered by employees to pay tax withholdings (in shares) | 0 | |||
Shares surrendered by employees to pay tax withholdings | 0 | 0 | ||
Exercise of stock options and employee stock purchase plan (in shares) | 864,000 | |||
Exercise of stock options and employee stock purchase plan | 5,467 | $ 9 | 5,458 | |
Net loss | (26,985) | (26,985) | ||
Ending balance (in shares) at Dec. 31, 2021 | 41,737,000 | |||
Ending balance at Dec. 31, 2021 | 112,550 | $ 417 | 342,765 | (230,632) |
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation | 15,591 | 15,591 | ||
Issuance of restricted and performance stock units (in shares) | 343,000 | |||
Issuance of restricted and performance stock units | 0 | $ 3 | (3) | |
Exercise of stock options and employee stock purchase plan (in shares) | 365,000 | |||
Exercise of stock options and employee stock purchase plan | 1,806 | $ 4 | 1,802 | |
Net loss | $ (28,948) | (28,948) | ||
Ending balance (in shares) at Dec. 31, 2022 | 42,445,517 | 42,445,000 | ||
Ending balance at Dec. 31, 2022 | $ 100,999 | $ 424 | 360,155 | (259,580) |
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation | 14,418 | 14,418 | ||
Issuance of restricted and performance stock units (in shares) | 369,000 | |||
Issuance of restricted and performance stock units | 0 | $ 4 | (4) | |
Exercise of stock options and employee stock purchase plan (in shares) | 310,000 | |||
Exercise of stock options and employee stock purchase plan | 1,964 | $ 3 | 1,961 | |
Net loss | $ (21,716) | (21,716) | ||
Ending balance (in shares) at Dec. 31, 2023 | 43,124,496 | 43,124,000 | ||
Ending balance at Dec. 31, 2023 | $ 95,665 | $ 431 | $ 376,530 | $ (281,296) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (21,716) | $ (28,948) | $ (26,985) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 4,218 | 2,827 | 2,744 |
Amortization of right-of-use assets | 1,062 | 1,761 | 1,795 |
Amortization of intangible assets | 273 | 265 | 202 |
Amortization of debt discount and deferred financing fees | 891 | 891 | 831 |
Loss on disposal of equipment | 56 | 0 | 0 |
(Recovery of) provision for bad debt | (271) | 612 | (41) |
Provision for inventory write-down | 1,939 | 1,769 | 3,314 |
Investment losses (gains) | (666) | (228) | 68 |
Change in fair value of derivatives | (1,531) | (1,044) | 28 |
Stock-based compensation | 14,418 | 15,591 | 10,919 |
Change in operating assets and liabilities: | |||
Accounts receivable | (2,691) | (4,639) | (499) |
Inventory | (6,054) | (3,656) | (7,478) |
Prepaid expenses and other | (867) | (84) | 2,435 |
Accounts payable and accrued expenses | 6,509 | 660 | (270) |
Operating lease obligations | (1,269) | (1,841) | (463) |
Cash paid for interest portion of finance leases | (3) | (2) | (2) |
Contract and other liabilities | (14) | 0 | (3) |
Net cash used in operating activities | (5,716) | (16,066) | (13,405) |
Cash flows from investing activities: | |||
Purchase of property and equipment | (13,872) | (20,078) | (27,811) |
Economic development grant proceeds | 0 | 0 | 950 |
Purchase of investments | (10,203) | (39,247) | (68,699) |
Proceeds from sale of investments | 44,374 | 57,300 | 72,500 |
Cash payments for intangible assets | (1,046) | (1,175) | (589) |
Net cash provided by (used in) investing activities | 19,253 | (3,200) | (23,649) |
Cash flows from financing activities: | |||
Proceeds from issuance of long-term debt | 0 | 0 | 15,000 |
Cash paid for debt portion of finance leases | (10) | (12) | (15) |
Proceeds from exercise of stock options and ESPP stock purchases | 1,964 | 1,806 | 5,467 |
Net cash provided by financing activities | 1,954 | 1,794 | 20,452 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 15,491 | (17,472) | (16,602) |
Cash, cash equivalents, and restricted cash, beginning of period | 21,535 | 39,007 | 55,609 |
Cash, cash equivalents, and restricted cash, end of period | 37,026 | 21,535 | 39,007 |
Supplemental disclosures of cash flow activity: | |||
Cash paid for interest, net of capitalized interest | 1,944 | 0 | 495 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Acquisition of fixed assets in accounts payable and accrued expenses | 704 | 866 | 1,420 |
Embedded derivative associated with the long-term debt | 0 | 0 | 3,037 |
Obtaining a right-of-use asset in exchange for a lease liability | 2,298 | 1,018 | 1,375 |
Acquisition of intangible assets in accounts payable and accrued expenses | $ 407 | $ 299 | $ 418 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business Axogen, Inc. (together with its wholly-owned subsidiaries, the “Company”) was incorporated in Minnesota. Our business is focused on the science, development and commercialization of the technologies used for the peripheral nerve regeneration and repair. The Company's products include Avance ® Nerve Graft, Axoguard Nerve Connector ® , , Axoguard Nerve Protector ® , Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap ® and Axotouch ® Two-Point Discriminator . The Company is headquartered in Florida. The Company has processing, warehousing, and distribution facilities in Ohio and Texas. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements of the Company are prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP"). All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The significant estimates affecting the amounts reported or disclosed in the consolidated financial statements include the realizable value of inventories, the valuation of stock-based compensation and the valuation of derivative instruments and the fair value of debt instruments. Other estimates that affect the amounts reported or disclosed in the consolidated financial statements include the allowance for doubtful accounts, the useful life and recoverability of long-lived assets, incremental borrowing rates for operating leases, accounting for income taxes including the realizability of deferred tax assets and the related valuation allowance. The Company bases its estimates on historical and anticipated results, trends, and various other assumptions that management believes are reasonable under the circumstances, including assumptions as to future events. Actual results may differ from those estimates. Risk and Uncertainties The Company is dependent on its suppliers, including single source suppliers, some of which are outside of the U.S., and the inability of these suppliers to deliver necessary components of its products in a timely manner at prices, quality levels and volumes acceptable to the Company, or its inability to efficiently manage these components from these suppliers, could have a material adverse effect on its business, financial condition and operating results. Cash and Cash Equivalents Cash and cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of acquisition. Certain of the Company's cash and cash equivalents balances exceed Federal Deposit Insurance Corporation ("FDIC") insured limits or are invested in money market accounts with investment banks that are not FDIC-insured. The Company places its cash and cash equivalents in what they believe to be credit-worthy financial institutions. As of December 31, 2023, $30,524 of the cash and cash equivalents balance was in excess of FDIC limits. Restricted Cash Amounts included in restricted cash represent those required to be set aside to meet contractual terms of a lease agreement held by the Company. See Note 9 - Long-Term Debt, Net of Debt Discount and Financing Fees- Other Credit Facilities . The following table provides a reconciliation of cash and cash equivalents, and restricted cash reported in the consolidated balance sheets that sum to the total of the same reported in the consolidated statements of cash flows: (in thousands) December 31, December 31, Cash and cash equivalents $ 31,024 $ 15,284 Restricted cash 6,002 6,251 Total cash and cash equivalents, and restricted cash shown in the consolidated statements of cash flows 37,026 $ 21,535 Investments Investments consisted of commercial paper and U.S. government securities, were classified as available-for-sale and had maturities less than one year as of each balance sheet date. Investments were carried at fair value based upon quoted market prices. The Company elected the fair value option ("FVO") for all of its available-for-sale investments. The FVO election results in all changes in unrealized gains and losses being included in investment income in the consolidated statements of operations. Accounts Receivable and Allowance for Doubtful Accounts Account receivables are recorded at invoiced amounts and do not bear interest. The Company grants credit to customers in the normal course of business, but generally does not require collateral or other security to support its receivables. An allowance for doubtful accounts is established for estimated uncollectible receivables based on the Company's assessment of the collectability of customer accounts and recognizes the provision in general and administrative on the consolidated statements of operations. In determining the amount of the allowance, the Company considers aging of account balances, historical credit losses, customer-specific information, the current economic environment, supportable forecasts, and other relevant factors. Uncollectible receivables are written off against the allowance for doubtful accounts when all attempts to collect the receivable have been exhausted. Concentration Risk Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents, which are held at major financial institutions and trade receivables. The Company's products are sold on an uncollateralized basis and on credit terms. None of the Company's customers accounted for 10% or more of the consolidated revenues or accounts receivable during the years ended December 31, 2023, 2022, and 2021. Inventory Inventories, consisting of materials, direct labor and manufacturing overhead, are stated at the lower of cost or net realizable value. At each balance sheet date, the Company evaluates inventories for excess quantities, obsolescence or shelf-life. The Company monitors the shelf life of its products and historical expiration and spoilage trends, and reserves for inventory based on the estimated amount of inventory that will not be distributed before expiration or spoilage. To estimate the amount of inventory that will expire or spoil prior to being distributed, the Company reviews inventory quantities on hand, historical and projected distribution levels, historical expiration trends, and historical spoilage trends. The Company’s calculation of the amount of inventory that will expire prior to distribution has three components: 1) a spoilage-based component that compares historical spoilage rates to inventory quantities on hand 2) a demand or consumption-based component that compares projected distribution to inventory quantities on hand; and 3) an expiring inventory component that assesses the risk related to inventory that is near expiration. The Company’s model assumes that inventory will be distributed on a first-in-first-out basis. Due to the nature of the inventory (surgical implants with expiration dates) and the fact that a significant portion of the Company’s inventory is at medical facility consignment locations, estimating the amount of spoilage, the amount of inventory that will expire and the amount of inventory that should be reserved for involves significant judgments and estimates. Property and Equipment, Net Property and equipment, net are stated at historical cost less accumulated depreciation and amortization. Additions and improvements that extend the lives of the assets are capitalized, while expenditures for repairs and maintenance are expensed as incurred. Leasehold improvements are amortized on a straight-line basis over the shorter of the asset’s estimated useful life or the remaining lease term. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets ranging from three years. Gains or losses on the disposition of property and equipment are recorded in the period incurred and recorded as general and administrative expenses on the consolidated statement of operations. Capitalized Interest The interest cost on capital projects, including facilities build-outs, is capitalized and included in the cost of the project. Capitalization begins with the first expenditure for the project and continues until the project is substantially complete and ready for its intended use. For the years ended December 31, 2023, and 2022, the Company capitalized $5,285 and $6,155, respectively, of interest expense into property and equipment. Impairment of Long-Lived Assets The Company analyzes long-lived assets (asset groups), including property and equipment and definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable. An impairment is recognized when the estimated undiscounted cash flows generated by those assets is less than the carrying amounts of such assets. If it is determined that long-live asset (asset groups) is not recoverable, an impairment loss would be calculated based on the excess of the carrying value of the long-lived asset (asset groups) over the fair value of the long-lived asset (asset groups). There have been no impairments of long-lived assets during the years ended December 31, 2023, 2022, and 2021. Indefinite-lived intangible assets are not subject to amortization, however, annually in the third quarter or whenever an event occurs or circumstances indicate that the indefinite-lived intangible assets may be impaired, the Company evaluates qualitative factors to determine whether it is more likely or not that the fair value of the indefinite lived asset is less than its carrying amount. The Company's qualitative evaluation includes an assessment of factors, including specific operating results as well as industry, market and general economic conditions. The Company may elect to bypass this qualitative evaluation and perform a quantitative test. Intangible Assets, Net Intangible assets are recorded at cost and include patents and patent application costs, licenses, and trademarks. Intangible assets with finite lives are amortized on a straight-line basis over their estimated useful lives and reported net of accumulated amortization. Amortization expense is recorded in general and administrative expenses on the consolidated statements of operations. The useful lives of intangible assets are as follows: • License agreements (1) : 17 to 20 years • Patents: up to 20 years. • Trademarks: indefinite lived (1) The Company pays royalty fees based on net sales of the licensed products, which are recorded in sales and marketing on the consolidated statements of operation. The licenses expired during 2023. See Note 5 - Intangible Assets, Net. Global Nerve Foundation Periodically, the Company may make contributions to the Global Nerve Foundation ("GNF"), a related party, due to certain executives of the Company being members of GNF's board of directors. The GNF was incorporated in 2021 exclusively for charitable, educational, and scientific purposes and qualifies under IRC 501(c)(3) as an exempt private foundation. Under its charter, the GNF engages in activities that focus on improving the awareness and care of patients with peripheral nerve injuries through grants, contributions and other appropriate means. The GNF is a separate legal entity and is not a subsidiary of the Company; therefore, its results are not included in the accompanying consolidated financial statements. The Company contributed $0 and $700 to the GNF during the year ended December 31, 2023, and 2022, no amounts were contributed previously. These contributions were recorded in sales and marketing expense on the consolidated statement of operations. Fair Value The Company uses fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. Cash equivalents, investments and derivative instruments are recorded at fair value on a recurring basis. Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for classification and disclosure of fair value measurements as follows: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Derivative Instruments The Company reviews its debt instruments in determining whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as a derivative financial instrument. Embedded derivatives that are not clearly and closely related to the debt host are bifurcated and are recognized at fair value on the consolidated balance sheet with changes in fair value recognized as either a gain or loss on the consolidated statement of operations each reporting period. The fair value of embedded derivatives are measured based on equity markets and interest rates, as well as an estimate of the Company's nonperformance risk adjustment. This estimate includes an option adjusted spread and an estimate of the Company's risk-free rate. Leases The Company determines if a contract contains a lease at the inception date and determines the lease classification, recognition, and measurement at commencement date. All operating lease commitments with a lease term greater than 12 months are recognized as right-of-use assets and obligations on a discounted basis on the balance sheet. Leases with an initial term of 12 months or less are not recorded on the consolidated balance sheet. The Company classifies a lease based on whether the arrangement is effectively a purchase of the underlying asset. Leases that transfer the control of the underlying asset are classified as finance leases and all others are classified as operating leases. Interest and amortization expense are recognized for operating leases on a straight-line basis. If a change to the lease term leads to a reassessment of the lease classification and remeasurement, assumptions such as the discount rate and variable rents based on a rate or index will be updated as of the remeasurement date. If an arrangement is modified, the Company will reassess whether the arrangement contains a lease. Any subsequent changes in lease payments are recognized when incurred, unless the change requires a remeasurement of the lease liability. Certain of the Company's leases include options for the Company to extend the lease term. The exercise of lease renewal option is generally at the Company's sole discretion. Certain of the Company's lease agreements include provisions for the Company to reimburse the lessor for common area maintenance, real estate taxes, and insurance, which the Company accounts for as variable lease costs. The Company's lease agreements do not contain any material residual value guarantees or material restrictive covenants. Revenue Recognition The Company enters into contracts to sell and distribute products and services to hospitals and surgical facilities for use in caring for patients with peripheral nerve damage or transection. Revenue is recognized when the Company transfers control of the products and services to the Company’s customers when the product is shipped or when it is delivered to the customer depending on the agreement. Products are primarily transferred to customer at a point in time. A portion of the Company's product revenue is generated from consigned inventory maintained at hospitals and independent sales agencies, and also from inventory physically held by field sales representatives. For these types of product sales, the Company retains control until the product has been used or implanted, at which time revenue is recognized. In the case of products or services sold to a customer under a distribution or purchase agreement, the customers are granted exclusive distribution rights to sell the implants internationally in a territory defined by the contract. These international distributor agreements contain provisions that allow the Company to terminate the distribution agreement with the distributor, and upon termination, the right to repurchase inventory from the distributor at the distributor’s cost. The Company has determined that its contractual rights to repurchase distributor inventory upon termination of the distributor agreement are not substantive and do not impact the timing of when control transfers; and therefore, the Company has determined it is appropriate to recognize revenue when: i) the product is shipped vi a common carrier; or ii) the product is delivered to the customer or distributor, depending on the terms of the agreement. Determining the timing of revenue recognition for such contracts is subject to judgment, because an evaluation must be made regarding the distributor’s ability to direct the use of, and obtain substantially all of the remaining benefits from, the implants received from the Company. Changes in these assessments could have an impact on the timing of revenue recognition from sales to distributors. The Company accounts for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The Company operates in a single reportable segment of peripheral nerve repair, offers similar products to its customers, and enters into consistently structured arrangements with similar types of customers. As such, the Company does not disaggregate revenue from contracts with customers as the nature, amount, timing, and uncertainty of revenue and cash flows does not materially differ within and among the contracts with customers. The contract with the customer states the final terms of the sale, including the description, quantity, and price of each implant distributed. The payment terms and conditions in the Company’s contracts vary; however, as a common business practice, payment terms are typically due in full within 30 days of delivery. Since the customer agrees to a stated price in the contract that does not vary over the contract term, the contracts do not contain any material types of variable consideration, and contractual rights of return are not material. The Company has several contracts with distributors in international markets that include consideration paid to the customer in exchange for distinct marketing and other services. The Company records such consideration paid to the customer as a reduction to revenue from the contracts with those distributor customers, which totaled $1,056, $856 and $736 for the years ended December 31, 2023, 2022 and 2021, respectively. Government Assistance As there is no authoritative guidance under U.S. GAAP for accounting for grants to for-profit business entities, the Company accounts for the grants by analogy to International Accounting Standard ("IAS") 20 Accounting for Government Grants and Disclosures of Government Assistance ("IAS 20") . Government assistance and grants are recognized when there is reasonable assurance that the Company has met the requirements of the assistance and there is reasonable assurance that the grant will be received. The Company received government grants of $393, $158 and $1,164 duri ng the years ended December 31, 2023, 2022, and 2021 respectively. See Research and Development Costs below and Note 14. Commitments and Contingencies. Costs of Goods Sold Cost of goods sold includes materials, direct labor and manufacturing overhead costs related to each product sold or produced, including processing, quality assurance labor and scrap, inbound freight costs, as well as facility, warehousing and overhead supporting the Company's manufacturing operations. All of the Company's manufacturing costs are included in cost of goods sold on the consolidated statements of operations. Research and Development Cost s Research and development costs are charged to expense as incurred. Costs of research and development activities relate to product development, clinical trial expenses, and technical support of products. Costs primarily consist of salaries, wages, consulting and depreciation and maintenance of research facilities and equipment. The Company received certain government grants totaling $393, $158, and $214 w hich were recorded as an offset to research and development Shipping and Handling All shipping and handling costs, including facility and warehousing overhead, directly related to bringing the Company’s products to their final selling destination are included in sales and marketing expenses on the consolidated statements of operations totaling $5,048, $5,271, and $4,883 for the December 31, 2023, 2022, and 2021, respectively. Income Taxes The Company uses the asset and liability method to account for income taxes in accordance with the authoritative guidance for income taxes. Under this method, deferred tax assets and liabilities are determined based on future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and tax loss and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that has a greater than 50% likelihood of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company identifies and evaluates uncertain tax positions, if any, and recognizes the impact of uncertain tax positions for which there is a less than more-likely-than-not probability of the position being upheld when reviewed by the relevant taxing authority. Such positions are deemed to be unrecognized tax benefits and a corresponding liability is established on the consolidated balance sheet. The Company has not recognized a liability for uncertain tax positions. If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses. Share-Based Compensation Share-based compensation is in the form of stock options, restricted stock units ("RSU"), performance stock units ("PSU"), and recognized at, or above, the fair market value of the Company's common stock on the date of grant. The Company estimates the fair value of each stock option award on the date of grant using a multiple-point Black-Scholes option-pricing model. In addition, the Company measures stock options granted to employees at a premium price based on market conditions, such as the trading price of the Company’s common stock, using a Monte Carlo Simulation option-pricing model in estimating the fair value at the grant date. The Company estimates the fair value of RSU grants based upon the grant date closing market price of the Company’s common stock. The fair value of the PSU grants is based on the Company’s closing stock price on the grant date. The number of PSUs that will ultimately be earned is based upon the Company’s performance as measured against specified targets over the measurement period. Expectations related to the achievement of performance goals associated with PSU grants is assessed as of each reporting period and is used to determine whether PSU grants are expected to vest. If performance-based milestones related to PSU grants are not met or not expected to be met, any compensation expense recognized associated with such grants will be reversed. The Company recognizes expense for all stock-based compensation awards, including stock options, RSUs, and PSUs granted to employees eligible for retirement, as defined within the award notice and allowing for continued vesting post-retirement, over the retirement notice period and continuously updates its estimate of expense over the notice period each reporting period if a retirement notice has not been provided. The Company recognizes compensation expense related to the Employee Stock Purchase Plan (“ESPP”) based on the estimated fair value of the options on the date of grant. The Company estimates the grant date fair value, and the resulting stock-based compensation expense, using the Black-Scholes option pricing model for each purchase period. The grant date fair value is expensed on a straight-line basis over the offering period. The determination of fair value using option-pricing models, as indicated above, is affected by the Company’s stock price, as well as assumptions regarding several subjective variables. These variables include, but are not limited to, the Company’s expected stock price volatility over the expected term of the awards. The Company determines the expected term of each award giving consideration to the contractual terms, vesting schedules, and post-vesting forfeitures. The Company uses the risk-free interest rate on the implied yield available on U.S. Treasury issues with an equivalent remaining term approximately equal to the expected term of the award. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statements of operations. The expense is reduced for forfeitures as they occur. Net Loss Per Share Basic net loss per common share is computed by dividing reported net loss by the weighted average number of common shares outstanding during the period without consideration of potentially dilutive securities. Diluted net loss per share reflects the potential dilution that could occur if contracts to issue common stock were exercised or converted into common stock of the Company. Diluted net loss per share is the same as basic net loss per common share for all periods presented, since the effect of the potentially dilutive securities are anti-dilutive. Potential dilutive common share equivalents consist of the incremental common shares issuable upon exercise of vested stock options, RSUs, and PSUs. Recently Issued Accounting Pronouncements In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update 2023-09 — Income Taxes (Topic 740) — Improvements to Income Tax Disclosures ("ASU 2023-09"). The new guidance provides for disclosure on an annual basis of the following: (i) specific categories in the rate reconciliation, and (ii) additional information for reconciling items that meet a quantitative threshold of greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate. The amendment in ASU 2023-09 is effective for the annual periods beginning after December 15, 2025, early adoption is permitted. The Company expects to enhance annual income tax reporting disclosures based on the new requirements. In November 2023, the FASB issued Accounting Standard Update 2023-07 — Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"). The new guidance requires disclosure on an annual and interim basis of the following: (i) significant segment expenses regularly provided to the chief operating decision maker ("CODM") and a measure of segment profit or loss; (ii) an amount for other segment items by reportable segment and a description of its composition; (iii) all annual disclosures about a reportable segment's profit and loss and assets as currently required by Topic 280; (iv) clarify if the CODM uses more than one measure of a segment's profit or loss in assessing segment performance and deciding how to allocate resources; and (v) disclose title and position of the CODM and how the CODM uses the reported measures. Public entities with a single reportable segment are required to provide all the disclosures required by this amendment. The amendment in ASU 2023-07 is effective for the annual periods beginning after December 15, 2023, and for the quarters in the years after December 15, 2024, early adoption is permitted. The Company expects to enhance annual segment reporting disclosures based on the new requirements. Recently Adopted Accounting Pronouncements In December 2022, the FASB issued ASU 2022-06 - Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848 ("ASU 2022-06"). ASU 2022-06 amended Accounting Standards Codification 848 Reference Rate Reform and ASU 2020 - 4, Reference Rate Reform. The amendment in ASU 2022-06 defers the sunset date of Topic 848 from December 31, 2022, to December 31, 2024, after which entities will no longer be permitted to apply the relief in Topic 848. The new guidance provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met. The amendments apply only to contracts and hedging relationships that reference the London Interbank Offered Rate (“LIBOR”), or another reference rate expected to be discontinued due to reference rate reform. The Company early adopted ASU 2022-06 in the second quarter of 2023 and the adoption of this accounting standard did not have an impact on the Company's consolidated financial statements. All other ASUs issued and not yet effective as of December 31, 2023, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s current or future financial position or results of operations. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consists of the following: (in thousands) December 31, December 31, Finished goods $ 13,545 $ 12,651 Work in process 2,120 1,026 Raw materials 7,355 5,228 Inventory $ 23,020 $ 18,905 The provision for inventory write-down for the years ended as follows: December 31, (in thousands) 2023 2022 2021 Provision for inventory write-down $ 1,939 $ 1,769 $ 3,314 As of December 31, 2023, and 2022, we reserved $1,342 and $1,221, respectively, for potential losses relating to inventory. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net consist of the following: (in thousands) December 31, December 31, Furniture and equipment $ 8,741 $ 5,316 Building 60,679 — Leasehold improvements 15,348 15,482 Processing equipment 13,116 4,227 Land 731 731 Finance lease right-of-use assets 138 131 Projects in process 3,674 63,703 Property and equipment, at cost 102,427 89,590 Less: accumulated depreciation and amortization (13,697) (10,296) Property and equipment, net $ 88,730 $ 79,294 Depreciation expense is as follows for the years ended: December 31, (in thousands) 2023 2022 2021 Depreciation expense $ 4,218 $ 2,827 $ 2,744 |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Intangible Assets, Net Intangible assets consist of the following: December 31, 2023 December 31, 2022 (in thousands) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Amortizable intangible assets: Patents $ 4,905 $ (820) $ 4,085 $ 3,792 $ (621) $ 3,170 License agreements 1,101 (1,087) 14 1,101 (1,014) 87 Total amortizable intangible assets 6,006 (1,907) 4,099 4,893 (1,635) 3,258 Unamortized intangible assets: Trademarks 432 — 432 391 — 391 Total intangible assets $ 6,438 $ (1,907) $ 4,531 $ 5,284 $ (1,635) $ 3,649 The amortization expense is as follows for the years ended: December 31, (in thousands) 2023 2022 2021 Amortization expense 273 265 202 As of December 31, 2023, future amortization of patents and license agreements are as follows: Year Ending December 31, 2024 236 2025 236 2026 235 2027 232 2028 232 Thereafter 2,928 Total 4,099 License Agreements The Company has multiple license agreements with the University of Florida Research Foundation and the University of Texas at Austin (the "License Agreements") in which the Company acquired exclusive worldwide licenses for underlying technology used in repairing and regenerating nerves. The licensed technologies include the rights to issued patents and patents pending in the U.S. and international markets. The License Agreement with the University of Texas expired in September 2023 and the royalty obligations associated with the License Agreement with the University of Florida Research Foundation expired in December 2023. The Company paid royalty fees ranging from 1% to 3% under the License Agreements based on net sales of licensed products. Also, when the Company paid royalties to more than one licensor for sales of the same product, a royalty stack cap applies, capping total royalties at 3.75%. Royalty fees included in sales and marketing on the consolidated statement of operations are as follows for the years ended: (in thousands) December 31, 2023 2022 2021 Royalty fees $ 3,110 $ 3,103 $ 2,715 |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Fair Value Measurement The following tables represent the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2023, and 2022: (in thousands) Level 1 Level 2 Level 3 Total December 31, 2023 Assets: Money market funds $ 24,977 $ — $ — $ 24,977 Total assets $ 24,977 $ — $ — $ 24,977 Liabilities: Debt derivative liabilities $ — $ — $ 2,987 $ 2,987 Total liabilities $ — $ — $ 2,987 $ 2,987 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 10,354 $ — $ — $ 10,354 U.S. government securities 12,316 — — 12,316 Commercial paper — 21,189 — 21,189 Total assets $ 22,669 $ 21,189 $ — $ 43,859 Liabilities: Debt derivative liability $ — $ — $ 4,518 $ 4,518 Total liabilities $ — $ — $ 4,518 $ 4,518 The changes in Level 3 liabilities measured at fair value on a recurring basis were as follows: (in thousands) Debt Derivative Liabilities Balance, December 31, 2021 $ 5,562 Change in fair value included in net loss (1,044) Balance, December 31, 2022 4,518 Change in fair value included in net loss (1,531) Balance, December 31, 2023 $ 2,987 There were no changes in the levels or methodology of the measurement of financial assets or liabilities during the years ended December 31, 2023, and 2022. The fair value of cash, restricted cash, accounts receivable, accounts payable and accrued expenses approximates the carrying values because of the short-term nature of these instruments. The carrying value and fair value of the Credit Facility was $46,603 and $51,486 at December 31, 2023, respectively, and $45,712 and $50,293 at December 31, 2022, respectively. See Note 9 - Long-Term Debt, Net of Debt Discount and Financing Fees. The debt derivative liabilities are measured using a ‘with and without’ valuation model to compare the fair value of each tranche of the Credit Facility including the identified embedded derivative feature and the fair value of a plain vanilla note with the same terms. The fair value of the Credit Facility including the embedded derivative features was determined using a probability-weighted expected return model based on four potential settlement scenarios for the Credit Facility included in the table below. The estimated settlement value of each scenario, which would include any required make-whole payment (see Note 9 - Long-Term Debt, Net of Debt Discount and Financing Fees), is then discounted to present value using a discount rate that is derived based on the initial terms of the Credit Facility at issuance and corroborated utilizing a synthetic credit rating analysis. The significant inputs that are included in the valuation of the debt derivative liability - first tranche include: December 31, 2023 December 31, 2022 Input Remaining term (years) 3.5 years 4.5 years Maturity date June 30, 2027 June 30, 2027 Coupon rate 9.5% - 13.2% 9.5% - 12.7% Revenue participation payments Maximum each year Maximum each year Discount rate 12.06% 1 13.90 % 1 Probability of mandatory prepayment before 2024 N/A 2 5.0% 1 Estimated timing of mandatory prepayment event before 2024 N/A 2 December 31, 2023 1 Probability of mandatory prepayment 2024 or after 15.0% 1 15.0% 1 Estimated timing of mandatory prepayment event 2024 or after March 31, 2026 1 March 31, 2026 1 Probability of optional prepayment event 5.0% 1 5.0% 1 Estimated timing of optional prepayment event December 31, 2025 1 December 31, 2025 1 Probability of note held-to-maturity 3 80 % 1 75 % 1 1 Represents a significant unobservable input. 2 Scenario ended on December 31, 2023. 3 See Maturity date in table. The significant inputs that are included in the valuation of the debt derivative liability - second tranche include: December 31, 2023 December 31, 2022 Input Remaining term (years) 4.5 years 5.5 years Maturity date June 30, 2028 June 30, 2028 Coupon rate 9.5% - 13.2% 9.5% - 12.7% Revenue participation payments Maximum each year Maximum each year Discount rate 15.60 % 1 17.56 % 1 Probability of mandatory prepayment before 2024 N/A 2 5.0% 1 Estimated timing of mandatory prepayment event before 2024 N/A 2 December 31, 2023 1 Probability of mandatory prepayment 2024 or after 15.0% 1 15.0% 1 Estimated timing of mandatory prepayment event 2024 or after March 31, 2026 1 March 31, 2026 1 Probability of optional prepayment event 5.0% 1 5.0% 1 Estimated timing of optional prepayment event December 31, 2025 1 December 31, 2025 1 Probability of note held-to-maturity 3 80 % 1 75 % 1 1 Represents a significant unobservable input. 2 Scenario ended on December 31, 2023. 3 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following: (in thousands) December 31, December 31, Accounts payable $ 11,774 $ 8,964 Accrued expenses 3,180 4,520 Accrued compensation 13,929 8,959 Accounts payable and accrued expenses $ 28,883 $ 22,443 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | Leases The Company leases administrative, manufacturing, research and distribution facilities through operating leases. Several leases include fixed payments including rent and non-lease components such as common-area or other maintenance costs. The components of total lease expense for the years ended were as follows: December 31, (in thousands) 2023 2022 2021 Finance lease costs Amortization of right-of-use assets $ 4 $ 20 $ 22 Interest on lease obligations 3 2 2 Operating lease costs Operating lease costs 3,316 4,077 4,326 Short-term lease costs 520 72 10 Variable lease costs 1,438 1,241 744 Total lease expense $ 5,282 $ 5,412 $ 5,104 Supplemental balance sheet information related to the operating and financing leases is as follows: (In thousands, except lease term and discount rate) December 31, 2023 December 31, 2022 Operating Leases Right-of-use operating assets $ 15,562 $ 14,369 Current maturities of long-term lease obligations $ 1,541 $ 1,303 Long-term lease obligations $ 21,123 $ 20,387 Financing Leases Right-of-use financing leases (1) $ 28 $ 41 Current maturities of long-term lease obligations $ 6 $ 7 Long-term lease obligations $ 19 $ 18 Weighted average operating lease term (in years): 9.6 11 Weighted average financing term (in years): 6.5 4 Weighted average discount rate operating leases 10.99 % 10.58 % Weighted average discount rate financing leases 13.22 % 11.91 % (1) Financing leases are included in property and equipment, net on the consolidated balance sheets. Future minimum lease payments under operating and financing leases as of December 31, 2023, were as follows: (In thousands) Year ending December 31, 2024 $ 3,925 2025 4,134 2026 4,269 2027 3,106 2028 3,104 Thereafter 18,566 Total $ 37,104 Less: Imputed interest (14,415) Total lease liability 22,689 Less: Current lease liability (1,547) Long-term lease liability $ 21,142 New leases The Company accounts for new leases in accordance with ASC 842, Leases. On May 9, 2023, the Company entered into a Commercial Lease with JA-Cole L.P., with an effective date of May 9, 2023 (the "2023 JA-Cole Lease"). The 2023 JA-Cole Lease is for an additional 2,500 square feet of office and warehouse facility located in Burleson, Texas. The Commercial Lease has a commencement date of September 1, 2023, and an expiration date of September 30, 2027. The Company valued the 2023 JA-Cole Lease using a 13.9% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $98 o n the commencement date. On October 6, 2023, the Company entered into a Commercial Lease with JA-Cole L.P., with an effective date of September 27, 2023 (the "2023 JA-Cole Lease No. 2"). The 2023 JA-Cole Lease No. 2 is for an additional 2,500 square feet of office and warehouse facility located in Burleson, Texas. The Commercial Lease has a commencement date of October 6, 2023, and an expiration date of April 30, 20230. The Company valued the 2023 JA-Cole Lease No. 2 using a 14.2% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $138 on the commencement date. On December 27, 2023, the Company entered into the Ninth Amendment to License and Service Agreement ("Ninth Amendment") with Community Blood Center (d/b/a Community Tissue Services) with an effective date of December 21, 2023, pursuant to the original License and Services Agreement dated August 6, 2015. The Ninth Amendment has a commencement date of December 21, 2023, and an expiration date of December 31, 2026. The Company valued the Ninth Amendment using a 13.6% incremental borrowing rate and recorded a right-of-use asset and lease liability of $1,787 on the commencement date. Lease modifications The Company accounts for lease revisions as a lease modification in accordance with ASC 842, Leases , when the modification effectively terminates the existing lease and creates a new lease. On January 27, 2022, the Company entered into a Commercial Lease Amendment ("Amendment") with JA-Cole L.P., with an effective date of February 1, 2022, pursuant to the original Commercial Lease dated April 21, 2015, as amended (the "2015 JA-Cole Lease"). The 2015 JA-Cole Lease is for the office and warehouse facility located in Burleson, Texas. The Amendment revised the commencement date to May 1, 2022, and the expiration date to April 30, 2027. The Company valued the 2015 JA-Cole Lease using a 11.3% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $641 as a result of this amendment. On August 22, 2022, the Company entered into the First Amendment to Lease Agreement (the “First Amendment”) with JA-Cole, L.P. with an effective date of October 1, 2022, pursuant to the original Commercial Lease dated October 1, 2020, as amended (the "2020 JA-Cole Lease"). The 2020 JA-Cole Lease is for the office and warehouse facility located in Burleson, Texas. The First Amendment adds an additional 2,500 square feet to the Leased Premises, for a total of 5,000 square feet and revises the expiration date of the 2020 JA-Cole Lease to mean September 30, 2027. The Company valued the 2020 JA Cole Lease using a 12.8% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $221 as a result of this amendment. |
Leases | Leases The Company leases administrative, manufacturing, research and distribution facilities through operating leases. Several leases include fixed payments including rent and non-lease components such as common-area or other maintenance costs. The components of total lease expense for the years ended were as follows: December 31, (in thousands) 2023 2022 2021 Finance lease costs Amortization of right-of-use assets $ 4 $ 20 $ 22 Interest on lease obligations 3 2 2 Operating lease costs Operating lease costs 3,316 4,077 4,326 Short-term lease costs 520 72 10 Variable lease costs 1,438 1,241 744 Total lease expense $ 5,282 $ 5,412 $ 5,104 Supplemental balance sheet information related to the operating and financing leases is as follows: (In thousands, except lease term and discount rate) December 31, 2023 December 31, 2022 Operating Leases Right-of-use operating assets $ 15,562 $ 14,369 Current maturities of long-term lease obligations $ 1,541 $ 1,303 Long-term lease obligations $ 21,123 $ 20,387 Financing Leases Right-of-use financing leases (1) $ 28 $ 41 Current maturities of long-term lease obligations $ 6 $ 7 Long-term lease obligations $ 19 $ 18 Weighted average operating lease term (in years): 9.6 11 Weighted average financing term (in years): 6.5 4 Weighted average discount rate operating leases 10.99 % 10.58 % Weighted average discount rate financing leases 13.22 % 11.91 % (1) Financing leases are included in property and equipment, net on the consolidated balance sheets. Future minimum lease payments under operating and financing leases as of December 31, 2023, were as follows: (In thousands) Year ending December 31, 2024 $ 3,925 2025 4,134 2026 4,269 2027 3,106 2028 3,104 Thereafter 18,566 Total $ 37,104 Less: Imputed interest (14,415) Total lease liability 22,689 Less: Current lease liability (1,547) Long-term lease liability $ 21,142 New leases The Company accounts for new leases in accordance with ASC 842, Leases. On May 9, 2023, the Company entered into a Commercial Lease with JA-Cole L.P., with an effective date of May 9, 2023 (the "2023 JA-Cole Lease"). The 2023 JA-Cole Lease is for an additional 2,500 square feet of office and warehouse facility located in Burleson, Texas. The Commercial Lease has a commencement date of September 1, 2023, and an expiration date of September 30, 2027. The Company valued the 2023 JA-Cole Lease using a 13.9% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $98 o n the commencement date. On October 6, 2023, the Company entered into a Commercial Lease with JA-Cole L.P., with an effective date of September 27, 2023 (the "2023 JA-Cole Lease No. 2"). The 2023 JA-Cole Lease No. 2 is for an additional 2,500 square feet of office and warehouse facility located in Burleson, Texas. The Commercial Lease has a commencement date of October 6, 2023, and an expiration date of April 30, 20230. The Company valued the 2023 JA-Cole Lease No. 2 using a 14.2% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $138 on the commencement date. On December 27, 2023, the Company entered into the Ninth Amendment to License and Service Agreement ("Ninth Amendment") with Community Blood Center (d/b/a Community Tissue Services) with an effective date of December 21, 2023, pursuant to the original License and Services Agreement dated August 6, 2015. The Ninth Amendment has a commencement date of December 21, 2023, and an expiration date of December 31, 2026. The Company valued the Ninth Amendment using a 13.6% incremental borrowing rate and recorded a right-of-use asset and lease liability of $1,787 on the commencement date. Lease modifications The Company accounts for lease revisions as a lease modification in accordance with ASC 842, Leases , when the modification effectively terminates the existing lease and creates a new lease. On January 27, 2022, the Company entered into a Commercial Lease Amendment ("Amendment") with JA-Cole L.P., with an effective date of February 1, 2022, pursuant to the original Commercial Lease dated April 21, 2015, as amended (the "2015 JA-Cole Lease"). The 2015 JA-Cole Lease is for the office and warehouse facility located in Burleson, Texas. The Amendment revised the commencement date to May 1, 2022, and the expiration date to April 30, 2027. The Company valued the 2015 JA-Cole Lease using a 11.3% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $641 as a result of this amendment. On August 22, 2022, the Company entered into the First Amendment to Lease Agreement (the “First Amendment”) with JA-Cole, L.P. with an effective date of October 1, 2022, pursuant to the original Commercial Lease dated October 1, 2020, as amended (the "2020 JA-Cole Lease"). The 2020 JA-Cole Lease is for the office and warehouse facility located in Burleson, Texas. The First Amendment adds an additional 2,500 square feet to the Leased Premises, for a total of 5,000 square feet and revises the expiration date of the 2020 JA-Cole Lease to mean September 30, 2027. The Company valued the 2020 JA Cole Lease using a 12.8% incremental borrowing rate and recorded a right-of-use asset and a lease liability of $221 as a result of this amendment. |
Long-Term Debt_, Net of Debt Di
Long-Term Debt, Net of Debt Discount and Financing Fees | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt, Net of Debt Discount and Financing Fees | Long-Term Debt, Net of Debt Discount and Financing Fees Long-term debt, net of debt discount and financing fees consists of the following: (in thousands) December 31, 2023 December 31, 2022 Credit Facility - first tranche $ 35,000 $ 35,000 Credit Facility - second tranche 15,000 15,000 Less - unamortized debt discount and deferred financing fees (3,397) (4,288) Long-term debt, net of debt discount and financing fees $ 46,603 $ 45,712 Credit Facility On June 29, 2023, the Company amended its Credit Facility with Oberland Capital and its affiliates TPC Investments II LP and Argo LLC (collectively, the "Lender"). The term loan agreement for the Credit Facility was amended to transition the base interest rate from three-month LIBOR to Adjusted SOFR. The Company obtained the first tranche of $35,000 at closing on June 30, 2020. On June 30, 2021, the second tranche of $15,000 was drawn down by the Company. Each tranche under the Credit Facility requires quarterly interest payments for seven years. Interest is calculated as 7.5% plus the greater of Adjusted SOFR or 2.0% (12.99% as of December 31, 2023); provided that the interest rate shall never be less than 9.5%. Each tranche of the Credit Facility has a term of seven years from the date of issuance (with the first tranche issued on June 30, 2020, maturing on June 30, 2027, and the second tranche issued on June 30, 2021, maturing on June 30, 2028). In connection with the Credit Facility, the Company entered into a revenue participation agreement (the “Revenue Participation Agreement”) with the Lender, which provided that, among other things, a quarterly royalty payment as a percentage of the Company’s net revenues up to $70 million in any given year, after April 1, 2021, ending on the date upon which all amounts owed under the Credit Facility have been paid in full. This structure results in approximately 1.5% per year of additional interest payments on the outstanding loan amount. The Company recorded interest expense for this Revenue Participation Agreement of $756 for each of the years ended December 31, 2023, and 2022, respectively. The Company pays the quarterly debt interest on the last day of the quarter, and for the years ended December 31, 2023, and 2022, paid $6,436 and $5,074, respectively, to the Lender. The Company capitalized interest of $5,285 and $6,155 for the years ended December 31, 2023, and 2022, respectively, towards the costs to construct and retrofit its APC Facility in Vandalia, OH. See Note 14 - Commitments and Contingencies. To date, the Company has capitalized interest of $16,714 related to this project. The capitalized interest is recorded as part of property and equipment, net in the consolidated balance sheets. The amounts outstanding under the Credit Facility may be accelerated upon certain events, including: (a) required mandatory prepayments upon an asset sale; (b) in the event the Company is subject to (i) any litigation brought by a Governmental Authority (as defined in the Credit Facility) including intervention after litigation is commenced by a Person (as defined in the Credit Facility), or (ii) any final administrative action by a Governmental Authority, in each case arising out of or in connection with any of the Company’s registry studies, payments made to doctors or training activities with respect to healthcare professionals (excluding certain final administrative actions that have been fully and finally resolved by the parties pursuant to a settlement agreement) or (c) upon the occurrence of an event of default (either automatically or at the option of the Lender depending on the nature of the event). In addition, the Company has the right to prepay any amounts outstanding under the Credit Facility. Upon maturity or upon such earlier repayment of the Credit Facility, the Company will repay the principal balance and provide a make-whole payment calculated to generate an internal rate of return to the Lender equal to 11.5%, less the total of all quarterly interest and royalty payments previously paid to the Lender. See Note 14 - Commitments and Contingencies for further information related to the make-whole payment calculation. Upon the occurrence of an event of default, the interest rate incurred on amounts outstanding under the Credit Facility will be increased by 4%. The Credit Facility includes a financial covenant requiring the Company to achieve certain revenue targets each quarter. As of December 31, 2023, the Company was in compliance with all the covenants. In the event of a failure to meet such covenants the Company may avoid a default by electing to be subject to a liquidity covenant and meeting all of the obligations required by such covenant. The borrowings under the Credit Facility are secured by substantially all of the assets of the Company. The debt derivative liabilities are recorded at fair value, with the change in fair value reported in change in the fair value of the derivative on the consolidated statements of operations at each reporting date. See Note 6 - Fair Value Measurement. Unamortized Debt Discount and Financing Fees The unamortized debt discount consists of the remaining initial fair values of the embedded derivatives related to the Credit Facility. The financing fees for the Credit Facility were $642 and were recorded as a contra liability to long-term debt on the consolidated balance sheet. Amortization of debt discount and deferred financing fees for the years ended December 31, 2023, 2022 and 2021, was $891, $891 and $831, respectively, and recorded in interest expense using the effective interest rate method. Other Credit Facilities The Company had restricted cash of $6,002 and $6,251 at December 31, 2023, and 2022, respectively. The December 31, 2023, and 2022 balances both include $6,000, which represents collateral for an irrevocable standby letter of credit. In March 2021, the Company entered into an agreement which required an additional irrevocable standby letter of credit in the amount of $250, which was terminated during the third quarter of 2023. |
Basic and Diluted Loss per Comm
Basic and Diluted Loss per Common Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Loss per Common Share | Basic and Diluted Loss per Common Share The following reflects the net loss attributable to common shareholders and share data used in the basic and diluted earnings per share computations using the two-class method as of: December 31, (in thousands, except per share amounts) 2023 2022 2021 Numerator: Net loss $ (21,716) $ (28,948) $ (26,985) Denominator: Weighted-average common shares outstanding (Basic) 42,878,543 42,083,125 41,214,889 Weighted-average common shares outstanding (Diluted) 42,878,543 42,083,125 41,214,889 Net loss per common share (Basic and Diluted) $ (0.51) $ (0.69) $ (0.65) Anti-dilutive shares excluded from the calculation of diluted earnings per share (1) Stock options 4,404,765 3,133,865 1,364,567 Restricted stock units 386,402 454,430 333,276 (1) These common equivalent shares are not included in the diluted per share calculations as they would be anti-dilutive if the Company was in a net income position. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company maintains two stock-based incentive plans: the Axogen, Inc. 2019 Amended and Restated Long-Term Incentive Plan, as amended ("2019 Plan") approved by shareholders on May 25, 2022, which provides incentives through the grants of stock options, non-qualified stock options, PSUs and RSUs to employees, directors, and consultants which replaced the Company's 2010 Stock Incentive Plan ("2010 Plan") and the Axogen 2017 Employee Stock Purchase Plan (“2017 ESPP”). At the August 15, 2023, Annual Shareholder Meeting, approval was received to increase the number of shares available under the 2017 ESPP Plan by 600,000 to 1,200,000. As of December 31, 2023, there were 1,864,063 shares of common stock available for future grant under the 2019 Plan. Additionally, the Company issued 215,800 options and 112,500 restricted stock units as inducement grants to certain employees in accordance with Nasdaq Listing Rule 5635(c)(4). Stock-based compensation expense is included in the following line items in the accompanying consolidated statements of operations for the years ended: December 31, (in thousands) 2023 2022 2021 Costs of goods sold $ 796 $ 215 $ 157 Sales and marketing 2,982 2,341 2,905 Research and development 3,875 2,640 1,923 General and administrative 6,764 10,395 5,934 Total stock-based compensation expense $ 14,418 $ 15,591 $ 10,919 Stock Options The options granted to employees prior to July 1, 2017, typically vest 25% one year after the grant date and 12.5% every six months thereafter for the remaining three-year period until fully vested after four years. The options granted to employees after July 1, 2017, typically vest 50% two years after the grant date and 12.5% every six months thereafter for the remaining two-year period until fully vested after four years. The options granted to directors and certain options granted from time to time to certain executive officers have vested ratably over three years or 25% per quarter over one year. Options typically have terms ranging from seven The following weighted-average assumptions were used in the calculation of fair value for stock options granted for the following periods: Year Ended December 31, 2023 2022 2021 Expected term (in years) 5.40 6.01 5.88 Expected volatility 59.32 % 61.17 % 58.38 % Risk free interest rate 3.52 % 2.31 % 1.02 % Expected dividends — % — % — % The following table summarizes the Company's stock option activity for the year ended December 31, 2023: Options Weighted Weighted Aggregate Outstanding at December 31, 2022 3,894,856 $ 14.38 6.78 $ 2,783 Granted (1) 1,393,464 $ 7.88 Forfeited (740,319) $ 13.09 Exercised (175,758) $ 5.94 Outstanding at December 31, 2023 4,372,243 $ 12.87 6.43 $ 87 Exercisable at December 31, 2023 2,281,681 $ 16.33 4.26 $ 0 (1) Options granted include 215,800 inducement shares. in accordance with Nasdaq Listing Rule 5635(c)(4). The weighted-average grant-date fair value of stock options granted during the years ended December 31, 2023, 2022 and 2021 was $4.72, $4.65, $10.53, respectively. The total intrinsic value of options exercised for the years ended December 31, 2023, 2022 and 2021 was $1,710, $2,643 and $14,167, respectively. As of December 31, 2023, there was approximatel y $6,414 of total unrecognized compensation costs related to unvested stock options. These costs are expected to be recognized over a weighted-average period of 2.3 years. Restricted Stock Units RSUs granted to employees have a requisite service period of four years. The RSUs granted to directors and certain RSUs granted from time to time to certain executive officers have a requisite service period of three years, while certain of these RSUs have a requisite service period of one year. The Company expenses the fair value of RSUs on a straight-line basis over the requisite service period. The following table summarizes the activity for restricted stock units for the indicated periods: Outstanding Restricted Stock Units Stock Units Weighted Weighted Average Remaining Vesting Life (Years) Aggregate Intrinsic Value (in thousands) Unvested December 31, 2022 1,861,106 $ 11.13 1.60 $ 18,574 Granted (1) 1,359,500 $ 8.10 Released (324,731) $ 16.23 Forfeited (560,645) $ 9.70 Unvested December 31, 2023 2,335,230 $ 9.00 1.39 $ 15,950 (1) RSU granted include 112,500 inducements shares. in accordance with Nasdaq Listing Rule 5635(c)(4). The weighted-average grant-date fair value of restricted stock units granted during the years ended December 31, 2023, 2022 and 2021 was $8.10, $8.40, $20.13, respectively. As of December 31, 2023, there was approximately $12,530 of total unrecognized compensation costs related to unvested restricted stock. These costs are expected to be recognized over a weighted-average period of 2.51 years. The total fair market value of restricted stock vested during the years ended December 31, 2023, 2022 and 2021 was $2,685, $2,288 and $2,179, respectively. Performance Stock Units The Company estimates the fair value of the PSUs based on its closing stock price at the time of grant and its estimate of achieving such performance target and records compensation expense as the milestones are achieved. PSUs generally have a requisite service period of three years and are subject to graded vesting conditions based on revenue goals of the Company. The Company expenses their fair value over the requisite service period. Over the performance period, the number of shares of common stock that will ultimately vest and be issued and the related compensation expense will be adjusted based upon the Company’s estimate of achieving such performance target. The number of shares delivered to recipients and the related compensation cost recognized as an expense will be based on the actual performance metrics as set forth in the applicable PSU award agreement. The amount actually awarded will be based upon achievement of the performance measures. The following table summarizes the activity for performance stock units for the indicated periods: Outstanding Performance Stock Units Stock Units Weighted Weighted Average Remaining Vesting Life (Years) Aggregate Intrinsic Value (in thousands) Unvested December 31, 2022 1,112,031 $ 15.90 1.86 $ 11,098 Granted 747,870 8.29 Released (41,833) 12.00 Forfeited (560,656) 15.46 Unvested December 31, 2023 1,257,412 $ 11.69 1.76 $ 8,588 The weighted-average grant-date fair value of performance stock units during the years ended December 31, 2023, 2022 and 2021 was $8.29, $8.23 and $20.70, respectively. As of December 31, 2023, there was approximately $2,423 of total unrecognized compensation costs related to unvested performance stock. These costs are expected to be recognized over a weighted-average period of 1.76 years. The total fair market value of performance stock vested during the years ended December 31, 2023, 2022 and 2021 was $374, $673 and $2,302, respectively. PSU Awards On December 18, 2017, December 27, 2018, and December 17, 2019, the Compensation Committee of the Board of Directors approved PSU awards to certain employees related to their work on the Company’s Biologics License Application ("BLA"). As of December 31, 2023, 255,283 PSU awards were available to vest. The number of shares is allocated to certain milestones related to the BLA submission to and approval by the FDA. These awards are expected to begin vesting when the BLA is submitted to the FDA, which is not expected to be until the third quarter of 2024. The performance measure is based upon achieving each of the specific milestones and will vest 50% upon achieving each of the milestones and 50% one year later. No expense has been recognized on these awards. On March 16, 2021, the Compensation Committee of the Board of Directors approved PSU awards of 332,200 shares tied to 2022 revenue, with a payout ranging from 0% to 200% upon achievement of specific revenue goals. In the fourth quarter of 2021, it was determined that the performance metrics tied to 2022 revenue were no longer probable; therefore, stock compensation expense related to these awards of $1,831 was reversed in 2021. On March 16, 2022, the Compensation Committee of the Board of Directors approved PSU awards of 526,467 shares tied to revenue from 2022 to 2024 with a pay-out range from 0% to 150% upon achievement of specific revenue targets. At December 31, 2023, the total future stock compensation expense related to non-vested performance awards is expected to be $292 for those awards issued on March 16, 2022. On March 16, 2023, the Compensation Committee of the Board of Directors approved PSU awards of 744,000 shares tied to revenue from 2023 to 2025 with a pay-out range from 0% to 150% upon achievement of specific revenue targets. At December 31, 2023, the total future stock compensation expense related to non-vested performance awards is expected to be $2,226 for those awards issued on March 16, 2023. 2017 ESPP The 2017 ESPP allows eligible employees to acquire shares of the Company's common stock through payroll deductions at a discount to market price (currently 15.0%) of the lesser of the closing price of the Company’s common stock on the first day or last day of the offering period. The offering period is currently 6 months. Participants may not purchase more than $25 or 3,000 shares of the Company’s common stock in a calendar year through the ESPP. Stock-based compensation expense related to the 2017 ESPP, included in total stock-based compensation expense, was $333, $844 and $401 for the years ended December 31, 2023, 2022 and 2021, respectively. The following are the weighted average assumptions used in the valuation of ESPP options for the years ended December 31: December 31, 2023 2022 2021 Expected term (in years) 0.5 0.5 0.5 Expected volatility 53.6 % 66.5 % 48.0 % Risk-free interest rate 5.1 % 1.1 % 0.1 % Expected dividends — % — % — % The weighted-average grant-date fair value of ESPP options during the years ended December 31, 2023, 2022 and 2021 was $2.84, |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Deferred income taxes are accounted for using the balance sheet approach, which requires recognition of deferred tax assets and liabilities for the expected future consequences of temporary differences between the financial reporting basis and the tax basis of assets and liabilities, as measured by enacted state and federal tax rates. Deferred tax assets and deferred tax liabilities are as follows: (in thousands) December 31, December 31, Deferred tax assets: Net operating loss carryforwards $ 41,454 $ 42,716 Inventory write-down 347 503 Allowance for doubtful accounts 87 169 Lease obligations 5,867 5,643 Stock-based compensation 6,084 5,274 Capitalized research and development costs 11,530 6,357 Debt derivative liability 772 1,174 Charitable contributions 3 203 Accrued compensation 56 1,010 Total deferred tax assets 66,200 63,049 Deferred tax liabilities: Depreciation (978) (983) Amortization (51) (17) Right-of-use assets (4,031) (3,744) Contract liabilities — 4 Total deferred tax liabilities (5,060) (4,740) Net deferred tax assets 61,140 58,309 Valuation allowance $ (61,140) $ (58,309) A valuation allowance is provided to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more-likely-than-not that a portion or none of the deferred tax assets will be realized. As of December 31, 2023, and 2022, management assessed the realizability of deferred tax assets. After consideration of all the evidence, including reversal of deferred tax liabilities, future taxable income and other factors, management determined that a full valuation allowance was necessary as of December 31, 2023, and 2022. The valuation allowance increased by $2,831 and $5,058 during 2023 and 2022, respectively, primarily as a result of the increase in the capitalized research and development costs for tax purposes. The Company adopted Section 174 of the Tax Cuts and Jobs Act of 2017 ("TCJA") which requires taxpayers to capitalize and amortize research and development expenditures for the tax years beginning after December 31, 2022. This rule became effective for the Company during 2022 and resulted in capitalized research and development costs of $11,530 being recorded to deferred tax assets as of December 31, 2023. The difference between the financial statement income tax benefit and the income tax benefit using statutory rates is primarily due to a combination of items: valuation allowance; non-deductible permanent items such as meals, entertainment and equity compensation. The Company’s effective income tax rate differs from the statutory federal income tax rate as follows: December 31, 2023 2022 2021 Federal tax rate 21.0 % 21.0 % 21.0 % State taxes - net of Federal benefit 1.5 % 4.1 % 5.1 % Permanent items and other deductions (8.7) % (7.1) % (1.6) % Other (0.8) % (0.5) % 0.2 % Valuation allowance (13.0) % (17.5) % (24.7) % Effective income tax rate — % — % — % As of December 31, 2023, the Company had tax-effected net operating loss carryforwards of $41,254 to offset future taxable income. The Tax Cuts & Job Act (TCJA) enacted significant changes to Net Operating Loss ("NOL") utilization. NOL’s generated after January 1, 2018 limiting the NOL utilization to 80% of taxable income. The remaining 20% is carried forward to subsequent years. Net operating losses incurred in tax years beginning on or after January 1, 2018, are carried forward indefinitely. Net operating losses incurred in tax years prior to January 1, 2018, are subject to a twenty-year carryforward before expiring. A portion of the net operating loss carryforwards may expire due to limitations imposed by Section 382 of the Internal Revenue Code. Future utilization of the available net operating loss carryforward may be limited under Internal Revenue Code Section 382 as a result of changes in ownership. The Company files U.S. federal and state income tax returns in jurisdictions with varying statutes of limitations. In the normal course of business, the Company is subject to examination by taxing authorities throughout the U.S. These examinations could include examining the timing and amount of deductions, the allocation of income among various tax jurisdictions and compliance with federal, state, and local laws. The Company’s remaining open tax years subject to examination by federal tax authorities include the years ended December 31, 2020, through 2023. The Company's remaining open tax years subject to examination by state and foreign tax authorities include the years ended December 31, 2019, through 2023. However, for tax years 2004 through 2017, federal and state taxing authorities may examine and adjust loss carryforwards in the years in which those loss carryforwards are ultimately utilized. Legislation enacted in 2018, titled the Tax Cuts and Jobs Act of 2017, subjects a U.S. shareholder to tax on global intangible low-taxed income (“GILTI”) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income , states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI in the year the tax is incurred. The Company has no recorded income tax expense or income tax benefit for the years ended December 31, 2023, 2022, and 2021 due to the generation of net operating losses. The Company is in a three year cumulative loss and net Deferred Tax Asset (DTA) position, the benefits of which have been fully reserved as of December 31, 2023. The Company does not believe there are any additional tax refund opportunities currently available |
Retirement Plan_
Retirement Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Retirement Plan | Retirement Plan The Company sponsors the Axogen 401(k) plan (the "401(k) Plan"), a defined contribution plan covering substantially all employees of the Company. All full-time employees who have attained the age of 18 are eligible to participate in the 401(k) Plan. Eligibility is immediate upon employment and enrollment is available any time during employment. Participating employees may make annual pretax contributions to their accounts up to a maximum amount as limited by law. The 401(k) Plan requires the Company to make 100% matching contributions on up to 3% of the employee’s annual salary and 50% matching contributions on up to the next 2% of the employee’s annual salary as long as the employee participates in the 401(k) Plan. Both employee contributions and Company contributions vest immediately. Employer contributions to the 401(k) Plan were $1,612, $1,409, and $1,346 for the years ended December 31, 2023, 2022 and 2021, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Service Agreements The Company pays CTS a facility fee for the use of clean room/manufacturing, storage, and office space and for services in support of its product process including for routine sterilization of daily supplies, providing disposable supplies and microbial services, and office support. Pursuant to the CTS Agreement, the Company recorded expenses of $2,327, $2,278 and $2,466 for the years ended December 31, 2023, 2022, and 2021, respectively, and included in cost of goods sold. The CTS Agreement was amended on December 31, 2023, extending the term through December 31, 2026. The CTS Agreement may be terminated by either party by providing an eighteen-month written notice. The Company reduced its utilization of CTS in the fourth quarter 2023 for Avance, however, will continue to utilize CTS beyond 2023 for the processing of Avive +. In December 2011, the Company entered into a Master Services Agreement for Clinical Research and Related Services. The Company was required to pay $151 upon execution of this agreement and the remainder monthly based on activities associated with the execution of the Company's phase 3 pivotal clinical trial to support the biologics license application ("BLA") for Avance Nerve Graft. Payments made under this agreement were $191, $1,254 and $1,100 for the years ended December 31, 2023, 2022 and 2021, respectively. Distribution and Supply Agreements In August 2008, the Company entered into an exclusive distribution agreement with Cook Biotech Incorporated ("Cook Biotech") to distribute the Axoguard Nerve Connector and Axoguard Nerve Protector products worldwide and the parties subsequently amended the agreement on August 4, 2023. The distribution agreement expires on December 31, 2030. The Cook Biotech agreement establishes a formula for the transfer cost of the Axoguard products and requires certain minimum purchases by the Company, although, through mutual agreement, the parties have not established such minimums; and, to date, have not enforced such provision. Under the Cook Biotech agreement, the Company provides purchase orders to Cook Biotech, and Cook Biotech fulfills the purchase orders. The agreement allows for termination provisions for both parties. The loss of the ability to sell the Axoguard products could have a material adverse effect on the Company's business until other replacement products would be available. In June 2017, the Company entered into the Nerve End Cap Supply Agreement (the "Supply Agreement") with Cook Biotech whereby Cook Biotech is the exclusive contract manufacturer of the Axoguard Nerve Cap, and the parties subsequently amended the agreement on August 4, 2023. The Supply Agreement expires on December 31, 2030. The agreement establishes the terms and conditions in which Cook Biotech will manufacture the product to the Company Under the Supply Agreement the Company provides purchase orders to Cook Biotech and Cook Biotech fulfills the purchase orders. The agreement allows for termination provisions for both parties The loss of the ability to sell the Axoguard Nerve Cap products could have a material adverse effect on the Company's business until other replacement products would be available. In May 2023, the Company entered into a Supply and Manufacturing Agreement ("HA+ Supply Agreement") with Cook Biotech whereby Cook Biotech is the exclusive contract manufacturer of the Axoguard HA + Nerve Protector. The HA+ Supply Agreement expires on July 1, 2030. The Agreement establishes the terms and condition in which Cook Biotech will manufacture, package, label and deliver the product to the Company. Under the Cook Biotech agreement, the Company provides purchase orders to Cook Biotech, and Cook Biotech fulfills the purchase orders. The agreement allows for termination provisions for both parties The loss of the ability to sell the Axoguard products could have a material adverse effect on the Company's business until other replacement products would be available. On January 31, 2024, RTI Surgical, Inc. announced the acquisition of Cook Biotech. Although we do not expect the acquisition of Cook Biotech to have a material impact on our relationship with Cook Biotech or our operations. Processing Facilities The Company is highly dependent on the continued availability of its processing facilities at CTS and APC in Dayton, Ohio and could be harmed if the physical infrastructure of this facility is unavailable for any prolonged period of time. Certain Economic Development Grants The Company obtained certain economic development grants from state and local authorities totaling up to $2,685 including $1,250 of cash grants to offset costs to acquire and develop the APC Facility. The economic development grants are subject to certain job creation milestones by December 31, 2023, and have clawback clauses if the Company does not meet the job creation milestones. The Company requested an extension from the grant authorities to extend the job creation milestones and received approval to extend the evaluation date to December 31, 2024, and the expiration date to December 31, 2026. As of December 31, 2023, the Company had received $1,188 in cash grants during the years ended 2021 and 2020. Fair Value of the Debt Derivative Liabilities The fair value of the debt derivative liabilities is $2,987 as of December 31, 2023. The fair value of the debt derivative liabilities was determined using a probability-weighted expected return model based upon the four potential settlement scenarios for the Credit Facility which are described in Note 2 - Summary of Significant Accounting Policies – Derivative Instruments. The estimated settlement value of each scenario, includes any required make-whole payment see Note 9 - Long- Term Debt, Net of Debt Discount and Financing Fees, is then discounted to present value using a discount rate that is derived based upon the initial terms of the Credit Facility at issuance and corroborated utilizing a synthetic rating analysis. The calculated fair values under the four scenarios are then compared to the fair value of a plain vanilla note, with the difference reflecting the fair value of the debt derivative liabilities. The Company estimated the make-whole payments required under each scenario according to the terms of the Credit Facility to generate an internal rate of return equal to 11.5% through the scheduled maturity dates, less the total of all quarterly interest and royalty payments previously paid to the Lender. The calculation utilized the XIRR function in Microsoft Excel as required by the Credit Facility. If the debt is not prepaid but instead is held to its scheduled maturities, the Company’s estimate of the make-whole payment for the first and second tranches of the Credit Facility due on June 30, 2027, and June 30, 2028, respectively, are approximately zero. The Company has consistently applied this approach since the inception of the debt agreement on June 30, 2020. The Company has become aware that the Lender may have an alternative interpretation of the calculation of the make-whole payments that the Company believes does not properly utilize the same methodology utilized by the XIRR function in Microsoft Excel as described in the Credit Facility. The Company estimates the top end of the range of the make-whole payments if the debt is held to scheduled maturity under an alternative interpretation to be approximately $9,000 for the first tranche of the Credit Facility on June 30, 2027, and approximately $4,000 for the second tranche of the Credit Facility on June 30, 2028. Further, if the debt is prepaid prior to the scheduled maturity dates and subject to the alternative interpretation, the make-whole payment would be larger than the amounts herein. Other Commitments Certain executive officers of the Company are parties to employment contracts. Such contracts have severance payments for certain conditions including change of control. During 2023, the Company entered into certain severance agreements with former employees to pay $755 in severance and $300 in consulting fees in 2024, these amounts were included in accounts payable and accrued expenses on our consolidated balance sheet. The Company also entered into a Transition and Separation Agreement with its CEO on January 4, 2024, which will result in potential payments of $1,538 and $1,646 in 2024 and 2025, respectively, which i ncludes the CEO's 2023 bonus to be paid in March 2024, salary, 2024 bonus to paid in March of 2025, accrued PTO through January 5, 2025, nine months of senior advisory fees, and eighteen months of COBRA payments. Actual timing of payments are subject to the determination of the end of CEO Term per the Transition and Separation Agreement. Legal Proceedings The Company is and may be subject to various claims, lawsuits, and proceedings in the ordinary course of the Company's business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company. In the opinion of management, such claims are either adequately covered by insurance or otherwise indemnified, or are not expected, individually or in the aggregate, to result in a material, adverse effect on the Comp any's financial condition, results of operations or cash flows. However, it is possible that the Company's results of operations, financial position and cash flows in a particular period could be materially affected by these contingencies. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event On January 4, 2024, Karen Zaderej, the Chief Executive Officer (the “CEO”) and President of the Company informed the Company of her intention to retire in January 2025.Ms. Zaderej’s retirement will qualify as a Qualified Retirement under the terms of Ms. Zaderej’s equity award agreements, which allow for continuation of vesting of certain equity awards (the “Retirement Vesting”) following retirement pursuant to the terms of the retirement program the Compensation Committee of the Board approved in March 2022. Pursuant to the terms of the Transition and Separation Agreement, dated January 4, 2024, between the Company and Ms. Zaderej (the “Transition Agreement”), Ms. Zaderej will remain the Company’s CEO until the earlier of (i) January 4, 2025, (ii) the date the Board identifies a new CEO, or (iii) she is terminated with or without substantial cause (the “CEO Term”). During the CEO Term, Ms. Zaderej will continue to receive her base salary and benefits, as well as continued vesting of all unvested equity awards previously granted to Ms. Zaderej. At the conclusion of the CEO Term, Ms. Zaderej will cease vesting in all prior equity awards except for awards subject to Qualified Retirement (as defined below) treatment. Post the CEO Term, Ms. Zaderej would resign from all board and officer positions she holds with the Company and its affiliates. Following the CEO Term, she will provide transition services for nine months following the end of the CEO Term, unless such period is earlier terminated by the Board of Directors (the “Transition Period”). During the Transition Period, Ms. Zaderej will be employed as a senior advisor and will receive $112,500 per month for the first six months for 40 hours of work per week and $75,000 per month for the final three months for 20 hours of work per week to provide transition services as determined by the Board. Following the CEO Term and the first six months of the Transition Period, Ms. Zaderej will be reimbursed for continuation coverage under the Company’s medical plan through COBRA until the earlier of (i) 18 months, (ii) the date she becomes eligible for coverage under another employer’s medical plan, or (iii) she is no longer eligible for coverage through COBRA. Additionally, Ms. Zaderej will be entitled to receive her 2023 bonus, as well as a prorated bonus earned in 2024 during the CEO Term. On January 5, 2024, the Company and Peter J. Mariani, the Company's former CFO, entered into a Separation, Waiver and Release of Claims Agreement ("Separation Agreement") providing for the terms of his separation of employment with the Company. The separation was effective December 22, 2023, and provided for certain lump sum payments totaling $755 and $300 in a consulting agreement which extends through 2024 . |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2023 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | Schedule II – Valuation and Qualifying Accounts AXOGEN, INC. SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS THREE YEARS ENDED DECEMBER 31, 2023, 2022 AND 2021 (in thousands) Balance at Beginning of Year Additions Deductions (Charge-offs) Balance at End of Year Allowance for doubtful accounts 2021 $ 416 $ — $ (140) $ 276 2022 $ 276 $ 612 $ (238) $ 650 2023 $ 650 $ — $ (313) $ 337 Valuation allowance for deferred tax assets 2021 $ 46,517 $ 6,734 $ 53,251 2022 $ 53,251 $ 5,058 $ — $ 58,309 2023 $ 58,309 $ 2,831 $ — $ 61,140 Valuation for inventory reserves 2021 $ 1,553 $ 3,314 $ (2,291) $ 2,576 2022 2,576 1,769 (2,410) 1,935 2023 1,935 1,939 (2,533) 1,342 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The significant estimates affecting the amounts reported or disclosed in the consolidated financial statements include the realizable value of inventories, the valuation of stock-based compensation and the valuation of derivative instruments and the fair value of debt instruments. Other estimates that affect the amounts reported or disclosed in the consolidated financial statements include the allowance for doubtful accounts, the useful life and recoverability of long-lived assets, incremental borrowing rates for operating leases, accounting for income taxes including the realizability of deferred tax assets and the related valuation allowance. The Company bases its estimates on historical and anticipated results, trends, and various other assumptions that management believes are reasonable under the circumstances, including assumptions as to future events. Actual results may differ from those estimates. |
Risks and Uncertainties | Risk and Uncertainties The Company is dependent on its suppliers, including single source suppliers, some of which are outside of the U.S., and the inability of these suppliers to deliver necessary components of its products in a timely manner at prices, quality levels and volumes acceptable to the Company, or its inability to efficiently manage these components from these suppliers, could have a material adverse effect on its business, financial condition and operating results. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents Cash and cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of acquisition. Certain of the Company's cash and cash equivalents balances exceed Federal Deposit Insurance Corporation ("FDIC") insured limits or are invested in money market accounts with investment banks that are not FDIC-insured. The Company places its cash and cash equivalents in what they believe to be credit-worthy financial institutions. As of December 31, 2023, $30,524 of the cash and cash equivalents balance was in excess of FDIC limits. Restricted Cash Amounts included in restricted cash represent those required to be set aside to meet contractual terms of a lease agreement held by the Company. See Note 9 - Long-Term Debt, Net of Debt Discount and Financing Fees- Other Credit Facilities . |
Investments | Investments Investments consisted of commercial paper and U.S. government securities, were classified as available-for-sale and had maturities less than one year as of each balance sheet date. Investments were carried at fair value based upon quoted market prices. The Company elected the fair value option ("FVO") for all of its available-for-sale investments. The FVO election results in all changes in unrealized gains and losses being included in investment income in the consolidated statements of operations. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Account receivables are recorded at invoiced amounts and do not bear interest. The Company grants credit to customers in the normal course of business, but generally does not require collateral or other security to support its receivables. |
Concentration Risk | Concentration Risk Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents, which are held at major financial institutions and trade receivables. |
Inventory | Inventory Inventories, consisting of materials, direct labor and manufacturing overhead, are stated at the lower of cost or net realizable value. At each balance sheet date, the Company evaluates inventories for excess quantities, obsolescence or shelf-life. The Company monitors the shelf life of its products and historical expiration and spoilage trends, and reserves for inventory based on the estimated amount of inventory that will not be distributed before expiration or spoilage. To estimate the amount of inventory that will expire or spoil prior to being distributed, the Company reviews inventory quantities on hand, historical and projected distribution levels, historical expiration trends, and historical spoilage trends. The Company’s calculation of the amount of inventory that will expire prior to distribution has three components: 1) a spoilage-based component that compares historical spoilage rates to inventory quantities on hand 2) a demand or consumption-based component that compares projected distribution to inventory quantities on hand; and 3) an expiring inventory component that assesses the risk related to inventory that is near expiration. The Company’s model assumes that inventory will be distributed on a first-in-first-out basis. Due to the nature of the inventory (surgical implants with expiration dates) and the fact that a significant portion of the Company’s inventory is at medical facility consignment locations, estimating the amount of spoilage, the amount of inventory that will expire and the amount of inventory that should be reserved for involves significant judgments and estimates. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net are stated at historical cost less accumulated depreciation and amortization. Additions and improvements that extend the lives of the assets are capitalized, while expenditures for repairs and maintenance are expensed as incurred. Leasehold improvements are amortized on a straight-line basis over the shorter of the asset’s estimated useful life or the remaining lease term. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets ranging from three years. Gains or losses on the disposition of property and equipment are recorded in the period incurred and recorded as general and administrative expenses on the consolidated statement of operations. |
Capitalized Interest | Capitalized Interest The interest cost on capital projects, including facilities build-outs, is capitalized and included in the cost of the project. Capitalization begins with the first expenditure for the project and continues until the project is substantially complete and ready for its intended use. For the years ended December 31, 2023, and 2022, the Company capitalized $5,285 and $6,155, respectively, of interest expense into property and equipment. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company analyzes long-lived assets (asset groups), including property and equipment and definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable. An impairment is recognized when the estimated undiscounted cash flows generated by those assets is less than the carrying amounts of such assets. If it is determined that long-live asset (asset groups) is not recoverable, an impairment loss would be calculated based on the excess of the carrying value of the long-lived asset (asset groups) over the fair value of the long-lived asset (asset groups). There have been no impairments of long-lived assets during the years ended December 31, 2023, 2022, and 2021. Indefinite-lived intangible assets are not subject to amortization, however, annually in the third quarter or whenever an event occurs or circumstances indicate that the indefinite-lived intangible assets may be impaired, the Company evaluates qualitative factors to determine whether it is more likely or not that the fair value of the indefinite lived asset is less than its carrying amount. The Company's qualitative evaluation includes an assessment of factors, including specific operating results as well as industry, market and general economic conditions. The Company may elect to bypass this qualitative evaluation and perform a quantitative test. |
Intangible Assets, Net | Intangible Assets, Net Intangible assets are recorded at cost and include patents and patent application costs, licenses, and trademarks. Intangible assets with finite lives are amortized on a straight-line basis over their estimated useful lives and reported net of accumulated amortization. Amortization expense is recorded in general and administrative expenses on the consolidated statements of operations. The useful lives of intangible assets are as follows: • License agreements (1) : 17 to 20 years • Patents: up to 20 years. • Trademarks: indefinite lived (1) The Company pays royalty fees based on net sales of the licensed products, which are recorded in sales and marketing on the consolidated statements of operation. The licenses expired during 2023. See Note 5 - Intangible Assets, Net. |
Fair Value | Fair Value The Company uses fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. Cash equivalents, investments and derivative instruments are recorded at fair value on a recurring basis. Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for classification and disclosure of fair value measurements as follows: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Derivative Instruments | Derivative Instruments The Company reviews its debt instruments in determining whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as a derivative financial instrument. Embedded derivatives that are not clearly and closely related to the debt host are bifurcated and are recognized at fair value on the consolidated balance sheet with changes in fair value recognized as either a gain or loss on the consolidated statement of operations each reporting period. The fair value of embedded derivatives are measured based on equity markets and interest rates, as well as an estimate of the Company's nonperformance risk adjustment. This estimate includes an option adjusted spread and an estimate of the Company's risk-free rate. |
Leases | Leases The Company determines if a contract contains a lease at the inception date and determines the lease classification, recognition, and measurement at commencement date. All operating lease commitments with a lease term greater than 12 months are recognized as right-of-use assets and obligations on a discounted basis on the balance sheet. Leases with an initial term of 12 months or less are not recorded on the consolidated balance sheet. The Company classifies a lease based on whether the arrangement is effectively a purchase of the underlying asset. Leases that transfer the control of the underlying asset are classified as finance leases and all others are classified as operating leases. Interest and amortization expense are recognized for operating leases on a straight-line basis. If a change to the lease term leads to a reassessment of the lease classification and remeasurement, assumptions such as the discount rate and variable rents based on a rate or index will be updated as of the remeasurement date. If an arrangement is modified, the Company will reassess whether the arrangement contains a lease. Any subsequent changes in lease payments are recognized when incurred, unless the change requires a remeasurement of the lease liability. Certain of the Company's leases include options for the Company to extend the lease term. The exercise of lease renewal option is generally at the Company's sole discretion. Certain of the Company's lease agreements include provisions for the Company to reimburse the lessor for common area maintenance, real estate taxes, and insurance, which the Company accounts for as variable lease costs. The Company's lease agreements do not contain any material residual value guarantees or material restrictive covenants. |
Revenue Recognition | Revenue Recognition The Company enters into contracts to sell and distribute products and services to hospitals and surgical facilities for use in caring for patients with peripheral nerve damage or transection. Revenue is recognized when the Company transfers control of the products and services to the Company’s customers when the product is shipped or when it is delivered to the customer depending on the agreement. Products are primarily transferred to customer at a point in time. A portion of the Company's product revenue is generated from consigned inventory maintained at hospitals and independent sales agencies, and also from inventory physically held by field sales representatives. For these types of product sales, the Company retains control until the product has been used or implanted, at which time revenue is recognized. In the case of products or services sold to a customer under a distribution or purchase agreement, the customers are granted exclusive distribution rights to sell the implants internationally in a territory defined by the contract. These international distributor agreements contain provisions that allow the Company to terminate the distribution agreement with the distributor, and upon termination, the right to repurchase inventory from the distributor at the distributor’s cost. The Company has determined that its contractual rights to repurchase distributor inventory upon termination of the distributor agreement are not substantive and do not impact the timing of when control transfers; and therefore, the Company has determined it is appropriate to recognize revenue when: i) the product is shipped vi a common carrier; or ii) the product is delivered to the customer or distributor, depending on the terms of the agreement. Determining the timing of revenue recognition for such contracts is subject to judgment, because an evaluation must be made regarding the distributor’s ability to direct the use of, and obtain substantially all of the remaining benefits from, the implants received from the Company. Changes in these assessments could have an impact on the timing of revenue recognition from sales to distributors. The Company accounts for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The Company operates in a single reportable segment of peripheral nerve repair, offers similar products to its customers, and enters into consistently structured arrangements with similar types of customers. As such, the Company does not disaggregate revenue from contracts with customers as the nature, amount, timing, and uncertainty of revenue and cash flows does not materially differ within and among the contracts with customers. |
Government Assistance | Government Assistance As there is no authoritative guidance under U.S. GAAP for accounting for grants to for-profit business entities, the Company accounts for the grants by analogy to International Accounting Standard ("IAS") 20 Accounting for Government Grants and Disclosures of Government Assistance ("IAS 20") . Government assistance and grants are recognized when there is reasonable assurance that the Company has met the requirements of the assistance and there is reasonable assurance that the grant will be received. The Company received government grants of $393, $158 and $1,164 duri ng the years ended December 31, 2023, 2022, and 2021 respectively. See Research and Development Costs below and Note 14. Commitments and Contingencies. |
Cost of Goods Sold | Costs of Goods Sold Cost of goods sold includes materials, direct labor and manufacturing overhead costs related to each product sold or produced, including processing, quality assurance labor and scrap, inbound freight costs, as well as facility, warehousing and overhead supporting the Company's manufacturing operations. All of the Company's manufacturing costs are included in cost of goods sold on the consolidated statements of operations. |
Research and Development Costs | Research and Development Cost s Research and development costs are charged to expense as incurred. Costs of research and development activities relate to product development, clinical trial expenses, and technical support of products. Costs primarily consist of salaries, wages, consulting and depreciation and maintenance of research facilities and equipment. The Company received certain government grants totaling $393, $158, and $214 w hich were recorded as an offset to research and development |
Shipping and Handling | Shipping and Handling All shipping and handling costs, including facility and warehousing overhead, directly related to bringing the Company’s products to their final selling destination are included in sales and marketing expenses on the consolidated statements of operations totaling $5,048, $5,271, and $4,883 for the December 31, 2023, 2022, and 2021, respectively. |
Income Taxes | Income Taxes The Company uses the asset and liability method to account for income taxes in accordance with the authoritative guidance for income taxes. Under this method, deferred tax assets and liabilities are determined based on future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and tax loss and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that has a greater than 50% likelihood of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. |
Share-Based Compensation | Share-Based Compensation Share-based compensation is in the form of stock options, restricted stock units ("RSU"), performance stock units ("PSU"), and recognized at, or above, the fair market value of the Company's common stock on the date of grant. The Company estimates the fair value of each stock option award on the date of grant using a multiple-point Black-Scholes option-pricing model. In addition, the Company measures stock options granted to employees at a premium price based on market conditions, such as the trading price of the Company’s common stock, using a Monte Carlo Simulation option-pricing model in estimating the fair value at the grant date. The Company estimates the fair value of RSU grants based upon the grant date closing market price of the Company’s common stock. The fair value of the PSU grants is based on the Company’s closing stock price on the grant date. The number of PSUs that will ultimately be earned is based upon the Company’s performance as measured against specified targets over the measurement period. Expectations related to the achievement of performance goals associated with PSU grants is assessed as of each reporting period and is used to determine whether PSU grants are expected to vest. If performance-based milestones related to PSU grants are not met or not expected to be met, any compensation expense recognized associated with such grants will be reversed. The Company recognizes expense for all stock-based compensation awards, including stock options, RSUs, and PSUs granted to employees eligible for retirement, as defined within the award notice and allowing for continued vesting post-retirement, over the retirement notice period and continuously updates its estimate of expense over the notice period each reporting period if a retirement notice has not been provided. The Company recognizes compensation expense related to the Employee Stock Purchase Plan (“ESPP”) based on the estimated fair value of the options on the date of grant. The Company estimates the grant date fair value, and the resulting stock-based compensation expense, using the Black-Scholes option pricing model for each purchase period. The grant date fair value is expensed on a straight-line basis over the offering period. The determination of fair value using option-pricing models, as indicated above, is affected by the Company’s stock price, as well as assumptions regarding several subjective variables. These variables include, but are not limited to, the Company’s expected stock price volatility over the expected term of the awards. The Company determines the expected term of each award giving consideration to the contractual terms, vesting schedules, and post-vesting forfeitures. The Company uses the risk-free interest rate on the implied yield available on U.S. Treasury issues with an equivalent remaining term approximately equal to the expected term of the award. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statements of operations. The expense is reduced for forfeitures as they occur. |
Net Loss Per Share | Net Loss Per Share Basic net loss per common share is computed by dividing reported net loss by the weighted average number of common shares outstanding during the period without consideration of potentially dilutive securities. Diluted net loss per share reflects the potential dilution that could occur if contracts to issue common stock were exercised or converted into common stock of the Company. Diluted net loss per share is the same as basic net loss per common share for all periods presented, since the effect of the potentially dilutive securities are anti-dilutive. Potential dilutive common share equivalents consist of the incremental common shares issuable upon exercise of vested stock options, RSUs, and PSUs. |
Recently Issued Accounting Pronouncements and Recently Adopted Accounting Pronouncements | Recently Issued Accounting Pronouncements In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update 2023-09 — Income Taxes (Topic 740) — Improvements to Income Tax Disclosures ("ASU 2023-09"). The new guidance provides for disclosure on an annual basis of the following: (i) specific categories in the rate reconciliation, and (ii) additional information for reconciling items that meet a quantitative threshold of greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate. The amendment in ASU 2023-09 is effective for the annual periods beginning after December 15, 2025, early adoption is permitted. The Company expects to enhance annual income tax reporting disclosures based on the new requirements. In November 2023, the FASB issued Accounting Standard Update 2023-07 — Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"). The new guidance requires disclosure on an annual and interim basis of the following: (i) significant segment expenses regularly provided to the chief operating decision maker ("CODM") and a measure of segment profit or loss; (ii) an amount for other segment items by reportable segment and a description of its composition; (iii) all annual disclosures about a reportable segment's profit and loss and assets as currently required by Topic 280; (iv) clarify if the CODM uses more than one measure of a segment's profit or loss in assessing segment performance and deciding how to allocate resources; and (v) disclose title and position of the CODM and how the CODM uses the reported measures. Public entities with a single reportable segment are required to provide all the disclosures required by this amendment. The amendment in ASU 2023-07 is effective for the annual periods beginning after December 15, 2023, and for the quarters in the years after December 15, 2024, early adoption is permitted. The Company expects to enhance annual segment reporting disclosures based on the new requirements. Recently Adopted Accounting Pronouncements In December 2022, the FASB issued ASU 2022-06 - Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848 ("ASU 2022-06"). ASU 2022-06 amended Accounting Standards Codification 848 Reference Rate Reform and ASU 2020 - 4, Reference Rate Reform. The amendment in ASU 2022-06 defers the sunset date of Topic 848 from December 31, 2022, to December 31, 2024, after which entities will no longer be permitted to apply the relief in Topic 848. The new guidance provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met. The amendments apply only to contracts and hedging relationships that reference the London Interbank Offered Rate (“LIBOR”), or another reference rate expected to be discontinued due to reference rate reform. The Company early adopted ASU 2022-06 in the second quarter of 2023 and the adoption of this accounting standard did not have an impact on the Company's consolidated financial statements. All other ASUs issued and not yet effective as of December 31, 2023, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s current or future financial position or results of operations. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of reconciliation of cash, cash equivalents and restricted cash | The following table provides a reconciliation of cash and cash equivalents, and restricted cash reported in the consolidated balance sheets that sum to the total of the same reported in the consolidated statements of cash flows: (in thousands) December 31, December 31, Cash and cash equivalents $ 31,024 $ 15,284 Restricted cash 6,002 6,251 Total cash and cash equivalents, and restricted cash shown in the consolidated statements of cash flows 37,026 $ 21,535 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | Inventory consists of the following: (in thousands) December 31, December 31, Finished goods $ 13,545 $ 12,651 Work in process 2,120 1,026 Raw materials 7,355 5,228 Inventory $ 23,020 $ 18,905 The provision for inventory write-down for the years ended as follows: December 31, (in thousands) 2023 2022 2021 Provision for inventory write-down $ 1,939 $ 1,769 $ 3,314 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment, net | Property and equipment, net consist of the following: (in thousands) December 31, December 31, Furniture and equipment $ 8,741 $ 5,316 Building 60,679 — Leasehold improvements 15,348 15,482 Processing equipment 13,116 4,227 Land 731 731 Finance lease right-of-use assets 138 131 Projects in process 3,674 63,703 Property and equipment, at cost 102,427 89,590 Less: accumulated depreciation and amortization (13,697) (10,296) Property and equipment, net $ 88,730 $ 79,294 Depreciation expense is as follows for the years ended: December 31, (in thousands) 2023 2022 2021 Depreciation expense $ 4,218 $ 2,827 $ 2,744 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of finite-lived intangible assets | Intangible assets consist of the following: December 31, 2023 December 31, 2022 (in thousands) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Amortizable intangible assets: Patents $ 4,905 $ (820) $ 4,085 $ 3,792 $ (621) $ 3,170 License agreements 1,101 (1,087) 14 1,101 (1,014) 87 Total amortizable intangible assets 6,006 (1,907) 4,099 4,893 (1,635) 3,258 Unamortized intangible assets: Trademarks 432 — 432 391 — 391 Total intangible assets $ 6,438 $ (1,907) $ 4,531 $ 5,284 $ (1,635) $ 3,649 |
Schedule of indefinite-lived intangible assets | Intangible assets consist of the following: December 31, 2023 December 31, 2022 (in thousands) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Amortizable intangible assets: Patents $ 4,905 $ (820) $ 4,085 $ 3,792 $ (621) $ 3,170 License agreements 1,101 (1,087) 14 1,101 (1,014) 87 Total amortizable intangible assets 6,006 (1,907) 4,099 4,893 (1,635) 3,258 Unamortized intangible assets: Trademarks 432 — 432 391 — 391 Total intangible assets $ 6,438 $ (1,907) $ 4,531 $ 5,284 $ (1,635) $ 3,649 |
Schedule of amortization expense | The amortization expense is as follows for the years ended: December 31, (in thousands) 2023 2022 2021 Amortization expense 273 265 202 |
Schedule of future amortization | As of December 31, 2023, future amortization of patents and license agreements are as follows: Year Ending December 31, 2024 236 2025 236 2026 235 2027 232 2028 232 Thereafter 2,928 Total 4,099 |
Schedule of royalty expenses | Royalty fees included in sales and marketing on the consolidated statement of operations are as follows for the years ended: (in thousands) December 31, 2023 2022 2021 Royalty fees $ 3,110 $ 3,103 $ 2,715 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value financial assets measured on a recurring basis | The following tables represent the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2023, and 2022: (in thousands) Level 1 Level 2 Level 3 Total December 31, 2023 Assets: Money market funds $ 24,977 $ — $ — $ 24,977 Total assets $ 24,977 $ — $ — $ 24,977 Liabilities: Debt derivative liabilities $ — $ — $ 2,987 $ 2,987 Total liabilities $ — $ — $ 2,987 $ 2,987 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 10,354 $ — $ — $ 10,354 U.S. government securities 12,316 — — 12,316 Commercial paper — 21,189 — 21,189 Total assets $ 22,669 $ 21,189 $ — $ 43,859 Liabilities: Debt derivative liability $ — $ — $ 4,518 $ 4,518 Total liabilities $ — $ — $ 4,518 $ 4,518 |
Schedule of fair value instruments classified Level 3 | The changes in Level 3 liabilities measured at fair value on a recurring basis were as follows: (in thousands) Debt Derivative Liabilities Balance, December 31, 2021 $ 5,562 Change in fair value included in net loss (1,044) Balance, December 31, 2022 4,518 Change in fair value included in net loss (1,531) Balance, December 31, 2023 $ 2,987 |
Schedule of significant inputs in liability valuation | The significant inputs that are included in the valuation of the debt derivative liability - first tranche include: December 31, 2023 December 31, 2022 Input Remaining term (years) 3.5 years 4.5 years Maturity date June 30, 2027 June 30, 2027 Coupon rate 9.5% - 13.2% 9.5% - 12.7% Revenue participation payments Maximum each year Maximum each year Discount rate 12.06% 1 13.90 % 1 Probability of mandatory prepayment before 2024 N/A 2 5.0% 1 Estimated timing of mandatory prepayment event before 2024 N/A 2 December 31, 2023 1 Probability of mandatory prepayment 2024 or after 15.0% 1 15.0% 1 Estimated timing of mandatory prepayment event 2024 or after March 31, 2026 1 March 31, 2026 1 Probability of optional prepayment event 5.0% 1 5.0% 1 Estimated timing of optional prepayment event December 31, 2025 1 December 31, 2025 1 Probability of note held-to-maturity 3 80 % 1 75 % 1 1 Represents a significant unobservable input. 2 Scenario ended on December 31, 2023. 3 See Maturity date in table. The significant inputs that are included in the valuation of the debt derivative liability - second tranche include: December 31, 2023 December 31, 2022 Input Remaining term (years) 4.5 years 5.5 years Maturity date June 30, 2028 June 30, 2028 Coupon rate 9.5% - 13.2% 9.5% - 12.7% Revenue participation payments Maximum each year Maximum each year Discount rate 15.60 % 1 17.56 % 1 Probability of mandatory prepayment before 2024 N/A 2 5.0% 1 Estimated timing of mandatory prepayment event before 2024 N/A 2 December 31, 2023 1 Probability of mandatory prepayment 2024 or after 15.0% 1 15.0% 1 Estimated timing of mandatory prepayment event 2024 or after March 31, 2026 1 March 31, 2026 1 Probability of optional prepayment event 5.0% 1 5.0% 1 Estimated timing of optional prepayment event December 31, 2025 1 December 31, 2025 1 Probability of note held-to-maturity 3 80 % 1 75 % 1 1 Represents a significant unobservable input. 2 Scenario ended on December 31, 2023. 3 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of accounts payable and accrued expenses | Accounts payable and accrued expenses consist of the following: (in thousands) December 31, December 31, Accounts payable $ 11,774 $ 8,964 Accrued expenses 3,180 4,520 Accrued compensation 13,929 8,959 Accounts payable and accrued expenses $ 28,883 $ 22,443 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Schedule of components of total lease expense | The components of total lease expense for the years ended were as follows: December 31, (in thousands) 2023 2022 2021 Finance lease costs Amortization of right-of-use assets $ 4 $ 20 $ 22 Interest on lease obligations 3 2 2 Operating lease costs Operating lease costs 3,316 4,077 4,326 Short-term lease costs 520 72 10 Variable lease costs 1,438 1,241 744 Total lease expense $ 5,282 $ 5,412 $ 5,104 |
Schedule of supplemental balance sheet information | Supplemental balance sheet information related to the operating and financing leases is as follows: (In thousands, except lease term and discount rate) December 31, 2023 December 31, 2022 Operating Leases Right-of-use operating assets $ 15,562 $ 14,369 Current maturities of long-term lease obligations $ 1,541 $ 1,303 Long-term lease obligations $ 21,123 $ 20,387 Financing Leases Right-of-use financing leases (1) $ 28 $ 41 Current maturities of long-term lease obligations $ 6 $ 7 Long-term lease obligations $ 19 $ 18 Weighted average operating lease term (in years): 9.6 11 Weighted average financing term (in years): 6.5 4 Weighted average discount rate operating leases 10.99 % 10.58 % Weighted average discount rate financing leases 13.22 % 11.91 % (1) |
Schedule of operating lease maturity | Future minimum lease payments under operating and financing leases as of December 31, 2023, were as follows: (In thousands) Year ending December 31, 2024 $ 3,925 2025 4,134 2026 4,269 2027 3,106 2028 3,104 Thereafter 18,566 Total $ 37,104 Less: Imputed interest (14,415) Total lease liability 22,689 Less: Current lease liability (1,547) Long-term lease liability $ 21,142 |
Schedule of finance lease maturity | Future minimum lease payments under operating and financing leases as of December 31, 2023, were as follows: (In thousands) Year ending December 31, 2024 $ 3,925 2025 4,134 2026 4,269 2027 3,106 2028 3,104 Thereafter 18,566 Total $ 37,104 Less: Imputed interest (14,415) Total lease liability 22,689 Less: Current lease liability (1,547) Long-term lease liability $ 21,142 |
Long-Term Debt_, Net of Debt _2
Long-Term Debt, Net of Debt Discount and Financing Fees (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of long-term debt, net of financing fees | Long-term debt, net of debt discount and financing fees consists of the following: (in thousands) December 31, 2023 December 31, 2022 Credit Facility - first tranche $ 35,000 $ 35,000 Credit Facility - second tranche 15,000 15,000 Less - unamortized debt discount and deferred financing fees (3,397) (4,288) Long-term debt, net of debt discount and financing fees $ 46,603 $ 45,712 |
Basic and Diluted Loss per Co_2
Basic and Diluted Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of net loss per common share | The following reflects the net loss attributable to common shareholders and share data used in the basic and diluted earnings per share computations using the two-class method as of: December 31, (in thousands, except per share amounts) 2023 2022 2021 Numerator: Net loss $ (21,716) $ (28,948) $ (26,985) Denominator: Weighted-average common shares outstanding (Basic) 42,878,543 42,083,125 41,214,889 Weighted-average common shares outstanding (Diluted) 42,878,543 42,083,125 41,214,889 Net loss per common share (Basic and Diluted) $ (0.51) $ (0.69) $ (0.65) Anti-dilutive shares excluded from the calculation of diluted earnings per share (1) Stock options 4,404,765 3,133,865 1,364,567 Restricted stock units 386,402 454,430 333,276 (1) These common equivalent shares are not included in the diluted per share calculations as they would be anti-dilutive if the Company was in a net income position. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of stock-based compensation expense of consolidated statements | Stock-based compensation expense is included in the following line items in the accompanying consolidated statements of operations for the years ended: December 31, (in thousands) 2023 2022 2021 Costs of goods sold $ 796 $ 215 $ 157 Sales and marketing 2,982 2,341 2,905 Research and development 3,875 2,640 1,923 General and administrative 6,764 10,395 5,934 Total stock-based compensation expense $ 14,418 $ 15,591 $ 10,919 |
Schedule of weighted-average assumptions for options granted | The following weighted-average assumptions were used in the calculation of fair value for stock options granted for the following periods: Year Ended December 31, 2023 2022 2021 Expected term (in years) 5.40 6.01 5.88 Expected volatility 59.32 % 61.17 % 58.38 % Risk free interest rate 3.52 % 2.31 % 1.02 % Expected dividends — % — % — % The following are the weighted average assumptions used in the valuation of ESPP options for the years ended December 31: December 31, 2023 2022 2021 Expected term (in years) 0.5 0.5 0.5 Expected volatility 53.6 % 66.5 % 48.0 % Risk-free interest rate 5.1 % 1.1 % 0.1 % Expected dividends — % — % — % |
Schedule of stock option activity | The following table summarizes the Company's stock option activity for the year ended December 31, 2023: Options Weighted Weighted Aggregate Outstanding at December 31, 2022 3,894,856 $ 14.38 6.78 $ 2,783 Granted (1) 1,393,464 $ 7.88 Forfeited (740,319) $ 13.09 Exercised (175,758) $ 5.94 Outstanding at December 31, 2023 4,372,243 $ 12.87 6.43 $ 87 Exercisable at December 31, 2023 2,281,681 $ 16.33 4.26 $ 0 (1) |
Schedule of stock unit activity | The following table summarizes the activity for restricted stock units for the indicated periods: Outstanding Restricted Stock Units Stock Units Weighted Weighted Average Remaining Vesting Life (Years) Aggregate Intrinsic Value (in thousands) Unvested December 31, 2022 1,861,106 $ 11.13 1.60 $ 18,574 Granted (1) 1,359,500 $ 8.10 Released (324,731) $ 16.23 Forfeited (560,645) $ 9.70 Unvested December 31, 2023 2,335,230 $ 9.00 1.39 $ 15,950 (1) RSU granted include 112,500 inducements shares. in accordance with Nasdaq Listing Rule 5635(c)(4). The following table summarizes the activity for performance stock units for the indicated periods: Outstanding Performance Stock Units Stock Units Weighted Weighted Average Remaining Vesting Life (Years) Aggregate Intrinsic Value (in thousands) Unvested December 31, 2022 1,112,031 $ 15.90 1.86 $ 11,098 Granted 747,870 8.29 Released (41,833) 12.00 Forfeited (560,656) 15.46 Unvested December 31, 2023 1,257,412 $ 11.69 1.76 $ 8,588 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of differences between the carrying amount of assets and liabilities for financial reporting purposes and their respective income tax basis | Deferred income taxes are accounted for using the balance sheet approach, which requires recognition of deferred tax assets and liabilities for the expected future consequences of temporary differences between the financial reporting basis and the tax basis of assets and liabilities, as measured by enacted state and federal tax rates. Deferred tax assets and deferred tax liabilities are as follows: (in thousands) December 31, December 31, Deferred tax assets: Net operating loss carryforwards $ 41,454 $ 42,716 Inventory write-down 347 503 Allowance for doubtful accounts 87 169 Lease obligations 5,867 5,643 Stock-based compensation 6,084 5,274 Capitalized research and development costs 11,530 6,357 Debt derivative liability 772 1,174 Charitable contributions 3 203 Accrued compensation 56 1,010 Total deferred tax assets 66,200 63,049 Deferred tax liabilities: Depreciation (978) (983) Amortization (51) (17) Right-of-use assets (4,031) (3,744) Contract liabilities — 4 Total deferred tax liabilities (5,060) (4,740) Net deferred tax assets 61,140 58,309 Valuation allowance $ (61,140) $ (58,309) |
Schedule of effective income tax rate reconciliation | The Company’s effective income tax rate differs from the statutory federal income tax rate as follows: December 31, 2023 2022 2021 Federal tax rate 21.0 % 21.0 % 21.0 % State taxes - net of Federal benefit 1.5 % 4.1 % 5.1 % Permanent items and other deductions (8.7) % (7.1) % (1.6) % Other (0.8) % (0.5) % 0.2 % Valuation allowance (13.0) % (17.5) % (24.7) % Effective income tax rate — % — % — % |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash and cash equivalents balance outside of FDIC limit | $ 30,524 | ||
Interest costs capitalized | 5,285 | $ 6,155 | |
Contributions to charitable organization | 0 | 700 | |
Grants received | $ 393 | $ 158 | $ 1,164 |
Government Assistance, Statement of Income or Comprehensive Income [Extensible Enumeration] | Research and development | Research and development | Research and development |
Sales and marketing | $ 86,060 | $ 80,228 | $ 73,328 |
Reduction to revenue for distributor customers | 1,056 | 856 | 736 |
Research and Development Grants | |||
Grants received | 393 | 158 | 214 |
Shipping and Handling | |||
Sales and marketing | $ 5,048 | $ 5,271 | $ 4,883 |
Minimum | |||
Property and equipment, useful life (in years) | 3 years | ||
Minimum | License agreements | |||
Amortization period of intangible assets (in years) | 17 years | ||
Maximum | |||
Property and equipment, useful life (in years) | 39 years | ||
Age of doubtful accounts | 30 days | ||
Maximum | License agreements | |||
Amortization period of intangible assets (in years) | 20 years | ||
Maximum | Patents | |||
Amortization period of intangible assets (in years) | 20 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Reconciliation of Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 31,024 | $ 15,284 | ||
Restricted cash | 6,002 | 6,251 | ||
Total cash and cash equivalents, and restricted cash shown in the consolidated statements of cash flows | $ 37,026 | $ 21,535 | $ 39,007 | $ 55,609 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |||
Finished goods | $ 13,545 | $ 12,651 | |
Work in process | 2,120 | 1,026 | |
Raw materials | 7,355 | 5,228 | |
Inventory | 23,020 | 18,905 | |
Provision for inventory write-down | 1,939 | 1,769 | $ 3,314 |
Inventory reserves | $ 1,342 | $ 1,221 |
Property and Equipment, Net -Sc
Property and Equipment, Net -Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property and equipment | ||
Finance lease right-of-use assets | $ 138 | $ 131 |
Property and equipment, at cost | 102,427 | 89,590 |
Less: accumulated depreciation and amortization | (13,697) | (10,296) |
Property and equipment, net | 88,730 | 79,294 |
Furniture and equipment | ||
Property and equipment | ||
Property and equipment, at cost | 8,741 | 5,316 |
Building | ||
Property and equipment | ||
Property and equipment, at cost | 60,679 | 0 |
Leasehold improvements | ||
Property and equipment | ||
Property and equipment, at cost | 15,348 | 15,482 |
Processing equipment | ||
Property and equipment | ||
Property and equipment, at cost | 13,116 | 4,227 |
Land | ||
Property and equipment | ||
Property and equipment, at cost | 731 | 731 |
Projects in process | ||
Property and equipment | ||
Property and equipment, at cost | $ 3,674 | $ 63,703 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 4,218 | $ 2,827 | $ 2,744 |
Intangible Assets, Net - Compon
Intangible Assets, Net - Components of Intangible Assets, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Amortizable intangible assets: | ||
Gross Carrying Amount | $ 6,006 | $ 4,893 |
Accumulated Amortization | (1,907) | (1,635) |
Net Carrying Amount | 4,099 | 3,258 |
Unamortized intangible assets: | ||
Intangible assets, gross | 6,438 | 5,284 |
Intangible assets, net | 4,531 | 3,649 |
Trademarks | ||
Unamortized intangible assets: | ||
Carrying amount | 432 | 391 |
Patents | ||
Amortizable intangible assets: | ||
Gross Carrying Amount | 4,905 | 3,792 |
Accumulated Amortization | (820) | (621) |
Net Carrying Amount | 4,085 | 3,170 |
License agreements | ||
Amortizable intangible assets: | ||
Gross Carrying Amount | 1,101 | 1,101 |
Accumulated Amortization | (1,087) | (1,014) |
Net Carrying Amount | $ 14 | $ 87 |
Intangible Assets, Net - Amorti
Intangible Assets, Net - Amortization Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization expense | $ 273 | $ 265 | $ 202 |
Intangible Assets, Net - Future
Intangible Assets, Net - Future Amortization of Patents and License Agreements (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Intangible assets | ||
Net Carrying Amount | $ 4,099 | $ 3,258 |
Patents And License Agreements | ||
Intangible assets | ||
2024 | 236 | |
2025 | 236 | |
2026 | 235 | |
2027 | 232 | |
2028 | 232 | |
Thereafter | 2,928 | |
Net Carrying Amount | $ 4,099 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - License agreements | 12 Months Ended |
Dec. 31, 2023 | |
Minimum | |
Intangible assets | |
Royalty fees range under the license agreements | 1% |
Maximum | |
Intangible assets | |
Royalty fees range under the license agreements | 3% |
Royalty stack cap for royalties paid to more than one licensor for sales of the same product | 3.75% |
Intangible Assets, Net - Royalt
Intangible Assets, Net - Royalty Fees (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Sales and marketing | |||
Finite-Lived Intangible Assets | |||
Royalty fees | $ 3,110 | $ 3,103 | $ 2,715 |
Fair Value Measurement - Schedu
Fair Value Measurement - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt derivative liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt derivative liabilities | $ 2,987 | |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 24,977 | $ 43,859 |
Total liabilities | 2,987 | 4,518 |
Recurring | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 24,977 | 10,354 |
Recurring | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 12,316 | |
Recurring | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 21,189 | |
Recurring | Debt derivative liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt derivative liabilities | 2,987 | 4,518 |
Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 24,977 | 22,669 |
Total liabilities | 0 | 0 |
Recurring | Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 24,977 | 10,354 |
Recurring | Level 1 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 12,316 | |
Recurring | Level 1 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Recurring | Level 1 | Debt derivative liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt derivative liabilities | 0 | 0 |
Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 21,189 |
Total liabilities | 0 | 0 |
Recurring | Level 2 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
Recurring | Level 2 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Recurring | Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 21,189 | |
Recurring | Level 2 | Debt derivative liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt derivative liabilities | 0 | 0 |
Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
Total liabilities | 2,987 | 4,518 |
Recurring | Level 3 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
Recurring | Level 3 | U.S. government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Recurring | Level 3 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Recurring | Level 3 | Debt derivative liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt derivative liabilities | $ 2,987 | $ 4,518 |
Fair Value Measurement - Fair V
Fair Value Measurement - Fair Value of Instruments Classified as Level 3 (Details) - Level 3 - Recurring - Debt derivative liabilities - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 4,518 | $ 5,562 |
Change in fair value included in net loss | (1,531) | (1,044) |
Ending balance | $ 2,987 | $ 4,518 |
Fair Value Measurement - Narrat
Fair Value Measurement - Narrative (Details) - Credit Facility - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Long-term debt, gross | $ 46,603 | $ 45,712 | $ 15,000 | $ 35,000 |
Long-term debt, fair value | $ 51,486 | $ 50,293 |
Fair Value Measurement - Signif
Fair Value Measurement - Significant Inputs Included in the Valuation of the Debt Derivative Liability (Details) | Dec. 31, 2023 | Dec. 31, 2022 |
First Tranche | Mandatory Prepayment Rate | Probability of note held-to-maturity | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.80 | 0.75 |
Second Tranche | Mandatory Prepayment Rate | Probability of note held-to-maturity | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.80 | 0.75 |
Debt derivative liabilities | First Tranche | Remaining term (years) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 3.5 | 4.5 |
Debt derivative liabilities | First Tranche | Coupon rate | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.095 | 0.095 |
Debt derivative liabilities | First Tranche | Coupon rate | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.132 | 0.127 |
Debt derivative liabilities | First Tranche | Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.1206 | 0.1390 |
Debt derivative liabilities | First Tranche | Mandatory Prepayment Rate | Probability of mandatory prepayment before 2024 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.050 | |
Debt derivative liabilities | First Tranche | Mandatory Prepayment Rate | Probability of mandatory prepayment 2024 or after | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.150 | 0.150 |
Debt derivative liabilities | First Tranche | Mandatory Prepayment Rate | Probability of optional prepayment event | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.050 | 0.050 |
Debt derivative liabilities | Second Tranche | Remaining term (years) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 4.5 | 5.5 |
Debt derivative liabilities | Second Tranche | Coupon rate | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.095 | 0.095 |
Debt derivative liabilities | Second Tranche | Coupon rate | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.132 | 0.127 |
Debt derivative liabilities | Second Tranche | Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.1560 | 0.1756 |
Debt derivative liabilities | Second Tranche | Mandatory Prepayment Rate | Probability of mandatory prepayment before 2024 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.050 | |
Debt derivative liabilities | Second Tranche | Mandatory Prepayment Rate | Probability of mandatory prepayment 2024 or after | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.150 | 0.150 |
Debt derivative liabilities | Second Tranche | Mandatory Prepayment Rate | Probability of optional prepayment event | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.050 | 0.050 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 11,774 | $ 8,964 |
Accrued expenses | 3,180 | 4,520 |
Accrued compensation | 13,929 | 8,959 |
Accounts payable and accrued expenses | $ 28,883 | $ 22,443 |
Leases- Components of Total Lea
Leases- Components of Total Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Finance lease costs | |||
Amortization of right-of-use assets | $ 4 | $ 20 | $ 22 |
Interest on lease obligations | 3 | 2 | 2 |
Operating lease costs | |||
Operating lease costs | 3,316 | 4,077 | 4,326 |
Short-term lease costs | 520 | 72 | 10 |
Variable lease costs | 1,438 | 1,241 | 744 |
Total lease expense | $ 5,282 | $ 5,412 | $ 5,104 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Current maturities of long-term lease obligations | Current maturities of long-term lease obligations |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term lease obligations | Long-term lease obligations |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Current maturities of long-term lease obligations | Current maturities of long-term lease obligations |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term lease obligations | Long-term lease obligations |
Operating Leases | ||
Operating lease right-of-use assets | $ 15,562 | $ 14,369 |
Current maturities of long-term lease obligations | 1,541 | 1,303 |
Long-term lease obligations | 21,123 | 20,387 |
Financing Leases | ||
Finance lease right-of-use assets | 28 | 41 |
Current maturities of long-term lease obligations | 6 | 7 |
Long-term lease obligations | $ 19 | $ 18 |
Weighted average operating lease term (in years): | 9 years 7 months 6 days | 11 years |
Weighted average financing term (in years): | 6 years 6 months | 4 years |
Weighted average discount rate operating leases | 10.99% | 11.91% |
Weighted average discount rate financing leases | 13.22% | 10.58% |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Leases [Abstract] | |
2024 | $ 3,925 |
2025 | 4,134 |
2026 | 4,269 |
2027 | 3,106 |
2028 | 3,104 |
Thereafter | 18,566 |
Total | 37,104 |
Less: Imputed interest | (14,415) |
Total lease liability | 22,689 |
Less: Current lease liability | (1,547) |
Long-term lease liability | $ 21,142 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | Dec. 27, 2023 USD ($) | Oct. 06, 2023 USD ($) | May 09, 2023 USD ($) ft² | Aug. 22, 2022 USD ($) ft² | Jan. 27, 2022 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Lessee, Lease, Description [Line Items] | |||||||
Operating lease right-of-use assets | $ 15,562 | $ 14,369 | |||||
2023 Commercial Lease With JA-Cole L.P | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Size of building space | ft² | 2,500 | ||||||
Operating lease, incremental borrowing rate | 13.90% | ||||||
Operating lease right-of-use assets | $ 98 | ||||||
Operating lease liability | $ 98 | ||||||
2023 Commercial Lease With JA-Cole L.P., Lease No. 2 | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Operating lease, incremental borrowing rate | 14.20% | ||||||
Operating lease right-of-use assets | $ 138 | ||||||
Operating lease liability | $ 138 | ||||||
Community Blood Center License and Service Agreement, Ninth Amendment | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Operating lease, incremental borrowing rate | 13.60% | ||||||
Operating lease right-of-use assets | $ 1,787 | ||||||
Operating lease liability | $ 1,787 | ||||||
2015 Commercial Lease With JA-Cole L.P | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Operating lease, incremental borrowing rate | 12.80% | 11.30% | |||||
Operating lease right-of-use assets | $ 221 | $ 641 | |||||
Operating lease liability | $ 221 | $ 641 | |||||
Commercial Lease With JA-Cole L.P, First Amendment | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Size of building space | ft² | 2,500 | ||||||
Commercial Lease With JA-Cole L.P | |||||||
Lessee, Lease, Description [Line Items] | |||||||
Size of building space | ft² | 5,000 |
Long-Term Debt_, Net of Debt _3
Long-Term Debt, Net of Debt Discount and Financing Fees - Schedule of Carrying Values of Outstanding Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Less - unamortized debt discount and deferred financing fees | $ (3,397) | $ (4,288) |
Long-term debt, net of debt discount and financing fees | 46,603 | 45,712 |
First Tranche | ||
Debt Instrument [Line Items] | ||
Long-term debt, gross | 35,000 | 35,000 |
Second Tranche | ||
Debt Instrument [Line Items] | ||
Long-term debt, gross | $ 15,000 | $ 15,000 |
Long-Term Debt_, Net of Debt _4
Long-Term Debt, Net of Debt Discount and Financing Fees - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||||
Jun. 29, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | |
Debt Instrument [Line Items] | |||||||
Interest expense | $ 2,835 | $ 624 | $ 1,356 | ||||
Interest costs capitalized | 5,285 | 6,155 | |||||
Amortization of debt discount and deferred financing fees | 891 | 891 | $ 831 | ||||
Restricted cash | 6,002 | 6,251 | |||||
Standby Letters of Credit | |||||||
Debt Instrument [Line Items] | |||||||
Collateral amount | $ 250 | ||||||
Other Assets | |||||||
Debt Instrument [Line Items] | |||||||
Accumulated capitalized interest costs | 16,714 | ||||||
Restricted Cash | |||||||
Debt Instrument [Line Items] | |||||||
Collateral amount | 6,000 | 6,000 | |||||
Credit Facility | |||||||
Debt Instrument [Line Items] | |||||||
Principal balance | $ 46,603 | 45,712 | $ 15,000 | $ 35,000 | |||
Period for which quarterly interest payments are required | 7 years | ||||||
Interest rate | 7.50% | ||||||
Interest rate at period end | 12.99% | ||||||
Term of debt | 7 years | ||||||
Threshold revenue achievement for payment of additional quarterly royalty | $ 70,000 | ||||||
Additional payment percentage | 1.50% | ||||||
Interest expense | $ 756 | 756 | |||||
Interest paid | 6,436 | 5,074 | |||||
Make-whole payment, minimum required internal rate of return | 11.50% | ||||||
Interest rate increase in the event of default | 4% | ||||||
Financing costs | 642 | ||||||
Credit Facility | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Interest rate | 9.50% | ||||||
Credit Facility | Secured Overnight Financing Rate (SOFR) | |||||||
Debt Instrument [Line Items] | |||||||
Additional interest floor rate | 2% | ||||||
Second Tranche | |||||||
Debt Instrument [Line Items] | |||||||
Principal balance | 15,000 | 15,000 | |||||
First Tranche | |||||||
Debt Instrument [Line Items] | |||||||
Principal balance | $ 35,000 | $ 35,000 |
Basic and Diluted Loss per Co_3
Basic and Diluted Loss per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Numerator: | |||
Net loss | $ (21,716) | $ (28,948) | $ (26,985) |
Denominator: | |||
Weighted-average common shares outstanding (Basic) (in shares) | 42,878,543 | 42,083,125 | 41,214,889 |
Weighted-average common shares outstanding (Diluted) (in shares) | 42,878,543 | 42,083,125 | 41,214,889 |
Net loss per common share (Basic) (in USD per share) | $ (0.51) | $ (0.69) | $ (0.65) |
Net loss per common share (Diluted) (in USD per share) | $ (0.51) | $ (0.69) | $ (0.65) |
Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from the calculation of diluted earnings per share (in shares) | 4,404,765 | 3,133,865 | 1,364,567 |
Restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive shares excluded from the calculation of diluted earnings per share (in shares) | 386,402 | 454,430 | 333,276 |
Stock-Based Compensation - Over
Stock-Based Compensation - Overview of Equity Incentive Plans Narrative (Details) | 12 Months Ended | |
Aug. 15, 2023 shares | Dec. 31, 2023 plan shares | |
Stock Option Disclosures | ||
Number of share-based incentive plans | plan | 2 | |
Share Based Payment Arrangement Inducement Shares | ||
Stock Option Disclosures | ||
Granted (in shares) | 215,800 | |
Granted (in shares) | 112,500 | |
2017 ESPP | ||
Stock Option Disclosures | ||
Additional shares authorized for future issuance (in shares) | 600,000 | |
Shares authorized for issuance (in shares) | 1,200,000 | |
2019 Plan | ||
Stock Option Disclosures | ||
Shares authorized for issuance (in shares) | 1,864,063 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of consolidated statements of operations (Details) - 2019 Plan - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Option Disclosures | |||
Total stock-based compensation expense | $ 14,418 | $ 15,591 | $ 10,919 |
Costs of goods sold | |||
Stock Option Disclosures | |||
Total stock-based compensation expense | 796 | 215 | 157 |
Sales and marketing | |||
Stock Option Disclosures | |||
Total stock-based compensation expense | 2,982 | 2,341 | 2,905 |
Research and development | |||
Stock Option Disclosures | |||
Total stock-based compensation expense | 3,875 | 2,640 | 1,923 |
General and administrative | |||
Stock Option Disclosures | |||
Total stock-based compensation expense | $ 6,764 | $ 10,395 | $ 5,934 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Option Disclosures | |||
Intrinsic value of options exercised | $ 1,710 | $ 2,643 | $ 14,167 |
Weighted average period of recognition of unrecognized compensation expense | 2 years 3 months 18 days | ||
Prior Axogen Plan | Minimum | |||
Stock Option Disclosures | |||
Vesting period (in years) | 7 years | ||
Prior Axogen Plan | Maximum | |||
Stock Option Disclosures | |||
Vesting period (in years) | 10 years | ||
Stock options | |||
Stock Option Disclosures | |||
Weighted average grant date fair value (in dollars per share) | $ 4.72 | $ 4.65 | $ 10.53 |
Unrecognized compensation costs related to non-vested stock options and restricted stock awards | $ 6,414 | ||
Stock options | Prior Axogen Plan | |||
Stock Option Disclosures | |||
Vesting period (in years) | 4 years | ||
Stock options | Prior Axogen Plan | One Year After Grant Date | |||
Stock Option Disclosures | |||
Vesting percentage | 25% | ||
Vesting period (in years) | 1 year | ||
Stock options | Prior Axogen Plan | Tranche Two | |||
Stock Option Disclosures | |||
Vesting percentage | 12.50% | ||
Vesting period (in years) | 3 years | ||
Stock options | 2017 ESPP | |||
Stock Option Disclosures | |||
Vesting period (in years) | 4 years | ||
Stock options | 2017 ESPP | Tranche Two | |||
Stock Option Disclosures | |||
Vesting percentage | 12.50% | ||
Vesting period (in years) | 2 years | ||
Stock options | 2017 ESPP | Tranche One | |||
Stock Option Disclosures | |||
Vesting percentage | 50% | ||
Vesting period (in years) | 2 years | ||
Directors And Officers Stock Options | Per Quarter, Over One Year | |||
Stock Option Disclosures | |||
Vesting percentage | 25% | ||
Vesting period (in years) | 1 year | ||
Directors And Officers Stock Options | 2017 ESPP | |||
Stock Option Disclosures | |||
Vesting period (in years) | 3 years |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Weighted-Average Assumptions Used (Details) - Stock options | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Option Disclosures | |||
Expected term (in years) | 5 years 4 months 24 days | 6 years 3 days | 5 years 10 months 17 days |
Expected volatility | 59.32% | 61.17% | 58.38% |
Risk free interest rate | 3.52% | 2.31% | 1.02% |
Expected dividends | 0% | 0% | 0% |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock options | ||
Options | ||
Outstanding at the beginning of the period (in shares) | 3,894,856 | |
Granted (in shares) | 1,393,464 | |
Forfeited (in shares) | (740,319) | |
Exercised (in shares) | (175,758) | |
Outstanding at the end of the period (in shares) | 4,372,243 | 3,894,856 |
Exercisable (in shares) | 2,281,681 | |
Weighted Average Exercise Price | ||
Outstanding at the beginning of the period (in USD per share) | $ 14.38 | |
Granted (in USD per share) | 7.88 | |
Forfeited (in USD per share) | 13.09 | |
Exercised (in USD per share) | 5.94 | |
Outstanding at the end of the period (in USD per share) | 12.87 | $ 14.38 |
Exercisable (in USD per share) | $ 16.33 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||
Weighted Average Remaining Contractual Life, Outstanding (in years) | 6 years 5 months 4 days | 6 years 9 months 10 days |
Weighted Average Remaining Contractual Life, Exercisable (in years) | 4 years 3 months 3 days | |
Aggregate Intrinsic Value, Outstanding | $ 87 | $ 2,783 |
Aggregate Intrinsic Value, Exercisable | $ 0 | |
Share Based Payment Arrangement Inducement Shares | ||
Options | ||
Granted (in shares) | 215,800 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted and Performance Stock Units Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||||||
Mar. 16, 2023 | Mar. 16, 2022 | Mar. 16, 2021 | Dec. 17, 2019 | Dec. 27, 2018 | Dec. 18, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Option Disclosures | |||||||||
Weighted average period of recognition of unrecognized compensation expense | 2 years 3 months 18 days | ||||||||
Restricted stock units | |||||||||
Stock Option Disclosures | |||||||||
Vesting period (in years) | 4 years | ||||||||
Weighted average grant date fair value (in dollars per share) | $ 8.10 | $ 8.40 | $ 20.13 | ||||||
Unrecognized compensation costs related to non-vested stock options and restricted stock awards | $ 12,530 | ||||||||
Weighted average period of recognition of unrecognized compensation expense | 2 years 6 months 3 days | ||||||||
Total fair value of restricted stock vested | $ 2,685 | $ 2,288 | $ 2,179 | ||||||
Restricted stock units | Directors And Certain Executive Officers | |||||||||
Stock Option Disclosures | |||||||||
Vesting period (in years) | 3 years | ||||||||
Restricted stock units | Directors And Certain Executive Officers | Tranche One | |||||||||
Stock Option Disclosures | |||||||||
Vesting period (in years) | 1 year | ||||||||
Performance stock units | |||||||||
Stock Option Disclosures | |||||||||
Vesting period (in years) | 3 years | ||||||||
Weighted average grant date fair value (in dollars per share) | $ 8.29 | $ 8.23 | $ 20.70 | ||||||
Unrecognized compensation costs related to non-vested stock options and restricted stock awards | $ 2,423 | ||||||||
Weighted average period of recognition of unrecognized compensation expense | 1 year 9 months 3 days | ||||||||
Total fair value of restricted stock vested | $ 374 | $ 673 | $ 2,302 | ||||||
Unrecognized compensation expense | $ 2,226 | $ 292 | |||||||
PSU - BLA Milestones | |||||||||
Stock Option Disclosures | |||||||||
Shares authorized for issuance (in shares) | 255,283 | ||||||||
PSU - BLA Milestones | Tranche One | |||||||||
Stock Option Disclosures | |||||||||
Vesting percentage | 50% | 50% | 50% | ||||||
PSU - BLA Milestones | Tranche Two | |||||||||
Stock Option Disclosures | |||||||||
Vesting period (in years) | 1 year | 1 year | 1 year | ||||||
Vesting percentage | 50% | 50% | 50% | ||||||
2021 PSUs | |||||||||
Stock Option Disclosures | |||||||||
Shares authorized for issuance (in shares) | 332,200 | ||||||||
Value of grants reversed | $ 1,831 | ||||||||
2021 PSUs | Minimum | |||||||||
Stock Option Disclosures | |||||||||
Performance stock unit, payout opportunity | 0% | ||||||||
2021 PSUs | Maximum | |||||||||
Stock Option Disclosures | |||||||||
Performance stock unit, payout opportunity | 200% | ||||||||
2022 PSUs | |||||||||
Stock Option Disclosures | |||||||||
Shares authorized for issuance (in shares) | 744,000 | 526,467 | |||||||
2022 PSUs | Minimum | |||||||||
Stock Option Disclosures | |||||||||
Performance stock unit, payout opportunity | 0% | 0% | |||||||
2022 PSUs | Maximum | |||||||||
Stock Option Disclosures | |||||||||
Performance stock unit, payout opportunity | 150% | 150% |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Restricted and Performance Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restricted stock units | ||
Restricted and Performance Stock Units | ||
Outstanding at the beginning of the period (in shares) | 1,861,106 | |
Granted (in shares) | 1,359,500 | |
Released (in shares) | (324,731) | |
Forfeited (in shares) | (560,645) | |
Outstanding at the end of the period (in shares) | 2,335,230 | 1,861,106 |
Weighted Average Exercise Price | ||
Outstanding at the beginning of the period (in USD per share) | $ 11.13 | |
Granted (in USD per share) | 8.10 | |
Released (in USD per share) | 16.23 | |
Forfeited (in USD per share) | 9.70 | |
Outstanding at the end of the period (in USD per share) | $ 9 | $ 11.13 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Additional Disclosures [Abstract] | ||
Weighted Average Remaining Vesting Life (Years) | 1 year 4 months 20 days | 1 year 7 months 6 days |
Aggregate Intrinsic Value, Outstanding | $ 15,950 | $ 18,574 |
Share Based Payment Arrangement Inducement Shares | ||
Restricted and Performance Stock Units | ||
Granted (in shares) | 112,500 | |
Performance stock units | ||
Restricted and Performance Stock Units | ||
Outstanding at the beginning of the period (in shares) | 1,112,031 | |
Granted (in shares) | 747,870 | |
Released (in shares) | (41,833) | |
Forfeited (in shares) | (560,656) | |
Outstanding at the end of the period (in shares) | 1,257,412 | 1,112,031 |
Weighted Average Exercise Price | ||
Outstanding at the beginning of the period (in USD per share) | $ 15.90 | |
Granted (in USD per share) | 8.29 | |
Released (in USD per share) | 12 | |
Forfeited (in USD per share) | 15.46 | |
Outstanding at the end of the period (in USD per share) | $ 11.69 | $ 15.90 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Additional Disclosures [Abstract] | ||
Weighted Average Remaining Vesting Life (Years) | 1 year 9 months 3 days | 1 year 10 months 9 days |
Aggregate Intrinsic Value, Outstanding | $ 8,588 | $ 11,098 |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Aug. 15, 2023 | |
Employee Stock | ||||
Stock Option Disclosures | ||||
Weighted average grant date fair value (in dollars per share) | $ 2.84 | $ 2.87 | $ 5.18 | |
2017 ESPP | ||||
Stock Option Disclosures | ||||
Discount from market value on common stock | 15% | |||
Offering period | 6 months | |||
Maximum amount available to participants per year | $ 25 | |||
Shares authorized for issuance (in shares) | 1,200,000 | |||
2017 ESPP | Employee Stock | ||||
Stock Option Disclosures | ||||
Shares authorized for issuance (in shares) | 3,000 | |||
Total stock-based compensation expense | $ 333 | $ 844 | $ 401 |
Stock-Based Compensation - Su_5
Stock-Based Compensation - Summary of Weighted-Average Assumptions Used For 2017 ESPP (Details) - 2017 ESPP | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Option Disclosures | |||
Expected term (in years) | 6 months | 6 months | 6 months |
Expected volatility | 53.60% | 66.50% | 48% |
Risk free interest rate | 5.10% | 1.10% | 0.10% |
Expected dividends | 0% | 0% | 0% |
Income Taxes - Temporary Differ
Income Taxes - Temporary Differences (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 41,454 | $ 42,716 |
Inventory write-down | 347 | 503 |
Allowance for doubtful accounts | 87 | 169 |
Lease obligations | 5,867 | 5,643 |
Stock-based compensation | 6,084 | 5,274 |
Capitalized research and development costs | 11,530 | 6,357 |
Debt derivative liability | 772 | 1,174 |
Charitable contributions | 3 | 203 |
Accrued compensation | 56 | 1,010 |
Total deferred tax assets | 66,200 | 63,049 |
Deferred tax liabilities: | ||
Depreciation | (978) | (983) |
Amortization | (51) | (17) |
Right-of-use assets | (4,031) | (3,744) |
Contract liabilities | 0 | |
Contract liabilities | 4 | |
Total deferred tax liabilities | (5,060) | (4,740) |
Net deferred tax assets | 61,140 | 58,309 |
Valuation allowance | $ (61,140) | $ (58,309) |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Change in valuation allowance | $ 2,831,000 | $ 5,058,000 | |
Capitalized research and development costs | 11,530,000 | 6,357,000 | |
Operating loss carryforwards | 41,254,000 | ||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Federal tax rate | 21% | 21% | 21% |
State taxes - net of Federal benefit | 1.50% | 4.10% | 5.10% |
Permanent items and other deductions | (8.70%) | (7.10%) | (1.60%) |
Other | (0.80%) | (0.50%) | 0.20% |
Valuation allowance | (13.00%) | (17.50%) | (24.70%) |
Effective income tax rate | 0% | 0% | 0% |
Retirement Plan_ (Details)
Retirement Plan (Details) - AxoGen 401K Plan $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Defined Benefit Plan | |||
Age limit for eligibility to participate in the plan | 18 | ||
Employer contributions | $ 1,612 | $ 1,409 | $ 1,346 |
Employer's Contribution, First Tranche | |||
Defined Benefit Plan | |||
Matching contributions | 100% | ||
Employee contribution matched, percent | 3% | ||
Employer's Contribution, Second Tranche | |||
Defined Benefit Plan | |||
Matching contributions | 50% | ||
Employee contribution matched, percent | 2% |
Commitments and Contingencies -
Commitments and Contingencies - Service Agreements Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2011 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
CTS Agreement | ||||
Service Agreements | ||||
License fee amount | $ 2,327 | $ 2,278 | $ 2,466 | |
Notice period for termination of agreement | 18 months | |||
Master Services Agreement For Clinical Research and Related Services | ||||
Service Agreements | ||||
Service agreement amount paid upon execution of agreement | $ 151 | |||
Payment for service fees | $ 191 | $ 1,254 | $ 1,100 |
Commitments and Contingencies_2
Commitments and Contingencies - Certain Economic Development Grants (Details) - APC Facility - Design Build Agreement - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Jul. 09, 2019 | |
Other Commitments [Line Items] | ||
Receivable economic development grants from state and local authorities (up to) | $ 2,685 | |
Cash grants receivable (up to) | $ 1,250 | |
Proceeds from grantors | $ 1,188 |
Commitments and Contingencies_3
Commitments and Contingencies - Fair Value of Debt Derivative Liabilities (Details) | Dec. 31, 2023 USD ($) settlementScenario |
Debt derivative liabilities | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Debt derivative liabilities | $ 2,987,000 |
Credit Facility | Debt derivative liabilities | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Number of potential settlement scenarios | settlementScenario | 4 |
Make-whole payment required under each scenario, internal rate of return | 11.50% |
First Tranche | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Held to maturity make-whole payment | $ 0 |
Held to maturity make-whole payment, alternative interpretation | 9,000,000 |
Second Tranche | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Held to maturity make-whole payment | 0 |
Held to maturity make-whole payment, alternative interpretation | $ 4,000,000 |
Commitments and Contingencies_4
Commitments and Contingencies - Other Commitments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2024 | Dec. 31, 2023 | |
Other Commitments [Line Items] | ||
Payment to former employees in 2024 | $ 1,538 | |
Payment to former employees in 2025 | $ 1,646 | |
Expected | ||
Other Commitments [Line Items] | ||
Severance | $ 755 | |
Consulting fees | $ 300 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) | 12 Months Ended | |
Jan. 04, 2024 | Dec. 31, 2024 | |
Expected | ||
Subsequent Event [Line Items] | ||
Severance | $ 755,000 | |
Consulting fees | $ 300,000 | |
Subsequent Event | Chief Executive Officer | Transition Payment, Period One | ||
Subsequent Event [Line Items] | ||
Transition period compensation | $ 112,500 | |
Subsequent Event | Chief Executive Officer | Transition Payment, Period Two | ||
Subsequent Event [Line Items] | ||
Transition period compensation | $ 75,000 |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Allowance for doubtful accounts | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | $ 650 | $ 276 | $ 416 |
Additions | 0 | 612 | 0 |
Deductions (Charge-offs) | (313) | (238) | (140) |
Balance at End of Year | 337 | 650 | 276 |
Valuation allowance for deferred tax assets | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | 58,309 | 53,251 | 46,517 |
Additions | 2,831 | 5,058 | 6,734 |
Deductions (Charge-offs) | 0 | 0 | |
Balance at End of Year | 61,140 | 58,309 | 53,251 |
Valuation for inventory reserves | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | 1,935 | 2,576 | 1,553 |
Additions | 1,939 | 1,769 | 3,314 |
Deductions (Charge-offs) | (2,533) | (2,410) | (2,291) |
Balance at End of Year | $ 1,342 | $ 1,935 | $ 2,576 |