Vericel Corp
For the period ended Dec 31, 2024. Filed Feb 27, 2025.
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FY2024 · Filed Feb 27, 2025
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Notes to Consolidated Financial Statements
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
- Organization
Vericel Corporation, a Michigan corporation (together with its consolidated subsidiaries referred to herein as the Company, or Vericel), was incorporated in March 1989 and began employee-based operations in 1991. The Company is a fully-integrated, commercial-stage biopharmaceutical company and is a leading provider of advanced therapies for the sports medicine and severe burn care markets. Vericel currently markets three commercial-stage products in the U.S., MACI®, Epicel® and NexoBrid®.
MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product that is indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Since MACI’s commercial launch, the product’s FDA-approved labeling has provided for a treating surgeon to use MACI to treat a patient through an open surgical procedure. In August 2024, the U.S. Food & Drug Administration (“FDA”) approved a supplemental Biologics License Application (“sBLA”) expanding the MACI indication to add instructions for the arthroscopic delivery of MACI to the product’s approved labeling. MACI Arthro™ allows surgeons to evaluate and prepare the cartilage defect site as well as deliver the MACI implant through small incisions using custom-designed arthroscopic instruments developed by the Company (“MACI Arthro instruments”). MACI Arthro became commercially available in the United States during the third quarter of 2024 and the Company began selling the MACI Arthro instruments at that time.
Epicel (cultured epidermal autografts) is a permanent skin replacement indicated for the treatment of adult and pediatric patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of a patient’s total body surface area (“TBSA”). The Company also holds an exclusive license from MediWound Ltd. (“MediWound”) for North American rights to NexoBrid (anacaulase-bcdb), a topically administered biological orphan product containing proteolytic enzymes, which is indicated for the removal of eschar in adult and pediatric patients with deep partial-thickness and/or full thickness thermal burns.
The Company is subject to risks common to companies in the life sciences industry including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, commercialization of existing and new products, and compliance with FDA regulations and approval requirements, as well as the ability to grow the Company’s business through appropriate commercial strategies.
In May 2019, the Company entered into exclusive license and supply agreements with MediWound, under which MediWound manufactures and supplies NexoBrid to the U.S. market on a unit price basis. MediWound develops and manufactures NexoBrid, in part, at its facilities in Yavne, Israel.
The Company continues to monitor the ongoing conflicts in the Middle East region involving Israel, and the Company is in close communication with MediWound leadership. MediWound’s NexoBrid manufacturing operations are continuing and, as of the date of this disclosure, MediWound does not anticipate a material disruption to its ongoing supply of commercial NexoBrid to the United States. To the extent the conflicts in the Middle East region intensify or expand and MediWound’s facilities in Israel are damaged or destroyed, travel to and from Israel is halted or inhibited, or significant key MediWound operational personnel are called to military service, MediWound’s ability to continue to supply NexoBrid to the U.S. market could be disrupted. As of the date of this report, the Company maintains an ample supply of NexoBrid at its U.S.-based third-party logistics provider.
Liquidity
The accompanying consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of December 31, 2024, the Company had an accumulated deficit of $392.8 million and had a net income of $10.4 million during the year ended December 31, 2024. The Company had cash and cash equivalents of $74.5 million and investments of $81.6 million as of December 31, 2024. The Company expects that cash from the sales of its products and existing cash, cash equivalents, investments, and available borrowing capacity will be sufficient to support the Company’s current operations through at least 12 months from the issuance of these consolidated financial statements. If
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revenues decline for a sustained period, the Company may need to access additional capital; however, the Company may not be able to obtain additional financing on acceptable terms or at all. The terms of any additional financing may adversely affect the holdings or the rights of the Company’s shareholders.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and investments in marketable debt securities. The Company may maintain deposits in financial institutions in excess of the insurance coverage offered by the Federal Deposit Insurance Corporation, the loss of which could have a negative effect on its operations and liquidity. The Company believes that it is not exposed to significant credit risk as its deposits, including cash and cash equivalents, are held at multiple high-credit-quality financial institutions. The Company has not experienced any losses on these deposits; however, no assurances can be provided that there will not be losses experienced in the future. The Company believes that the market risk arising from its holdings of these financial instruments is mitigated based on the fact that many of these securities are either government-backed or of high credit rating.
- Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with U.S. GAAP. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and accounts have been eliminated in consolidation.
Use of Estimates
The preparation of the 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 at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The more significant estimates reflected in the Company’s consolidated financial statements include, but are not limited to, certain judgments regarding revenue recognition, inventory valuation, stock option valuation, lease valuation, deferred tax assets and liabilities and accrued expenses. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments reflected in these consolidated financial statements or a revision of the carrying value of its assets or liabilities as of the issuance of these consolidated financial statements. These estimates may change as new events occur and additional information is obtained. Actual results could materially differ from those estimates.
Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase and consist primarily of demand deposits, money market funds, U.S. government securities, U.S. government agency bonds and commercial paper.
Restricted Cash
Restricted cash as of December 31, 2024 and 2023, represents amounts in a construction escrow account. See Note 5, “Leases” for further discussion.
Investments
Investments classified as short-term have maturities of less than one year. Investments classified as long-term are those that: (i) have a maturity of greater than one year, and (ii) the Company does not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale. The Company’s investment strategy is to buy short-duration marketable securities with a high credit rating. As of December 31, 2024 and 2023, all marketable securities held by the Company had remaining contractual maturities of three years or less.
Unrealized gains are included as a component of accumulated other comprehensive income in the consolidated balance sheets and consolidated statements of shareholders’ equity and a component of total comprehensive income (loss) in the consolidated statements of comprehensive income (loss), until realized. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses(“ASC 326”), to determine if the impairment is credit-related or non-credit-
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related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and non-credit-related impairment is recognized in other comprehensive income (loss), net of taxes.
Leases
The Company determines if an arrangement is a lease at inception, in accordance with ASC Topic 842, Leases. Operating lease commitments with a lease term greater than 12 months are recognized as right-of-use assets and liabilities, on a discounted basis on the balance sheet. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Certain of the Company’s lease agreements include lease payments that are adjusted periodically for an index or rate. The leases are initially measured using the present value of the projected payments adjusted for the index or rate in effect at the commencement date. In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance and other expenses, which do not transfer a good or service to the Company and are generally referred to as non-lease components. Variable non-lease components are not measured as part of the right-of-use asset and liability. Only when lease components and their associated non-lease components are fixed are they accounted for as a single lease component and are recognized as part of a right-of-use asset and liability. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants.
The Company has options to renew lease terms for facilities and other assets. Some leases contain clauses for renewal at the Company’s option with renewal terms that generally extend the lease term from 1 to 10 years. The exercise of lease renewal options is generally at the Company’s sole discretion. The Company evaluates renewal and termination options at the lease commencement date to determine if it is reasonably certain to exercise the option on the basis of economic factors. Certain lease agreements contain options to terminate the lease. A portfolio approach is applied to certain lease contracts with similar characteristics.
The Company uses a discount rate to calculate the present value of lease payments in order to determine lease classification and measurement of the lease asset and liability. In the absence of a rate of interest that is readily determinable in the contract, the Company estimates the incremental borrowing rate (“IBR”) for each lease based on the information available at commencement. The IBR reflects the rate of interest that the Company would pay on the lease commencement date to borrow an amount equal to the lease payments on a collateralized basis over a similar term in similar economic environments.
Inventory
Inventories are measured at the lower of cost or net realizable value. Cost is calculated based upon standard-cost which approximates costs determined on the first-in, first-out method. The Company periodically reviews its inventories for excess or obsolescence and writes down obsolete or other unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by the Company, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. Amounts written down are charged to cost of product sales.
Accounts Receivable
Accounts receivable are initially recorded at the contractual amount owed by the customer or based on expected payments from the insurance provider, hospital or patient. Allowances for doubtful accounts are established when the facts and circumstances indicate that a receivable may not be collectible. Potential credit risk exposure has been evaluated for the Company’s accounts receivable in accordance with ASC 326. The Company assesses risk and determines a loss percentage by pooling accounts receivable based on similar risk characteristics. The loss percentage is calculated through the use of forecasts that are based on current and historical economic and financial information.
Property and Equipment, net
Property and equipment are initially measured and recognized at acquisition cost, including any directly attributable cost of preparing the asset for its intended use. After initial measurement, property and equipment are carried at cost less accumulated depreciation. Repair and maintenance costs of property and equipment are expensed as incurred.
The depreciable value of property and equipment is depreciated on a straight-line basis over the useful life of the asset. The useful life of an asset is usually equivalent to its economic life. The useful lives of property and equipment are as follows:
Machinery and equipment:3 to 10 years
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Furniture, fixtures and office equipment:5 years
Computer equipment and software:3 years
Leasehold improvements: shorter of the remaining life of the lease or 15 years
The costs of assets retired or otherwise disposed of and the accumulated depreciation thereon are removed from the accounts, with any gain or loss realized upon sale or disposal credited or charged to operations.
Intangible Assets, net
The Company amortizes its intangible assets on a straight-line basis over their estimated economic lives, unless another amortization method is deemed to be more appropriate. In determining the useful lives of intangible assets, the Company considers the expected use of the assets and the effects of obsolescence, demand, competition, anticipated technological advances, market influence and other economic factors.
Long-Lived Assets
The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be fully recoverable. No impairment was identified or recorded during the years ended December 31, 2024, 2023 and 2022.
Revenue Recognition
The Company recognizes product revenue from sales to a customer following the five step model in Accounting Standards Codification 606, Revenue Recognition (“ASC 606”): (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation. Under this revenue standard, the Company recognizes revenue when its customer obtains control of the promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods. There are no contractual rights of returns, refunds or similar obligations related to MACI, MACI biopsy kits, MACI Arthro instruments or Epicel; however, in certain limited cases the Company will accept a product return if a surgery is canceled. Revenue is not recognized in certain canceled cases. There are limited contractual rights of returns, refunds, or similar obligations related to NexoBrid.
For MACI, MACI biopsy kits, MACI Arthro instruments, Epicel and NexoBrid, there are no variable pricing arrangements related to warranties or rebates offered to customers. The majority of orders are due within 30 to 90 days of delivery. Shipping and handling fees are included as a component of revenue. The Company recognizes any commission fees as an expense when incurred. These fees are included in selling, general, and administrative expenses. See Note 3, “Revenue” for further discussion on revenues.
Research and Development Expense
Research and development expenses are expensed as incurred. These expenditures relate to the development of new products, improvement of existing products, technical support of products and compliance with governmental regulations for the protection of consumers and patients.
Stock-Based Compensation
The Company’s accounting for stock-based compensation requires it to determine the fair value of common stock issued in the form of stock option awards and restricted stock units. The fair value of restricted stock units held by employees and non-employee directors is determined based on the fair value of the Company’s common stock on the date of the grant. Compensation expense is recorded for restricted stock units that are expected to vest over the expected vesting period. The fair value of stock options held by employees and non-employee directors is determined using a Black-Scholes option valuation method. Key assumptions in determining fair value include volatility, risk-free interest rate, dividend yield and expected term. The assumptions used in calculating the fair value of stock options represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and different assumptions are used, the stock-based compensation expense could be materially different in the future. In addition, the Company estimates the expected forfeiture rate and only recognizes expense for those stock options expected to vest over the service period. The estimated forfeiture rate considers the historical experience of the Company’s stock-based awards. If the
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actual forfeiture rate is different from the estimate, expense is adjusted accordingly. The Company records the expense for stock options and restricted stock units using a graded-vesting attribution method.
The Company also has an Employee Stock Purchase Plan (“ESPP”) which is a compensatory plan. Compensation expense is recorded based on the fair value of the purchased options at the grant date, which corresponds to the first day of each purchase period, and is amortized over the purchase period.
Comprehensive Income (Loss)
Comprehensive income (loss) is the change in shareholders’ equity during a period arising from unrealized gains or losses related to the Company’s investments.
Income Taxes
Deferred tax assets are recognized for deductible temporary differences and tax credit carryforwards and deferred tax liabilities are recognized for taxable temporary differences. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized based on the weight of available evidence. When evaluating the realizability of the deferred tax assets, all evidence, both positive and negative, is considered. Items considered when evaluating the need for a valuation allowance include the ability to carry back losses, future reversals of existing temporary differences, tax planning strategies, and expectations of future earnings.
The Company records uncertain tax positions in the consolidated financial statements only if it is more likely than not that the uncertain tax position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain tax positions in income tax expense.
Net Income (Loss) Per Common Share
Basic earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period, plus the potential dilutive effect of other securities if those securities were converted or exercised. During periods in which the Company incurs net losses, both basic and diluted loss per common share is calculated by dividing the net loss by the weighted-average shares of common stock outstanding and potentially dilutive securities are excluded from the calculation because their effect would be antidilutive.
Financial Instruments
The Company’s financial instruments include cash, cash equivalents, accounts receivables, accounts payable and accrued expenses for which the current carrying amounts approximate market value, based upon their short-term nature, deferred compensation plan liability carried at fair value, and marketable debt securities which are classified as available-for-sale and carried at fair value on a settlement date basis.
Recent Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The disclosure requirements must be applied retrospectively to all prior periods presented in the financial statements. The effective date for the standard is for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-07 as of December 31, 2024 and the adoption of this standard is disclosed in the footnotes of the Company’s consolidated financial statements.
No other accounting standards were adopted during the year ended December 31, 2024. The Company considers the applicability and impact of any recent Accounting Standards Updates (“ASU's”) issued by the Financial Accounting Standards Board (“FASB”), as noted below.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, to provide more detailed income tax disclosure requirements. The guidance requires entities to disclose disaggregated information about their effective
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tax rate reconciliation as well as information on income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. The effective date for the standard is for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires new disclosures to disaggregate prescribed natural expenses underlying any income statement caption. This standard is effective for annual periods in fiscal years beginning after December 15, 2026, and interim periods thereafter, with early adoption permitted, and will be applied on a prospective basis. The Company is currently evaluating the impact of this guidance on the consolidated financial statements and disclosures.
- Revenue
Revenue Recognition and Product Sales, Net
As disclosed in Note 2, the Company recognizes product revenue from sales of MACI biopsy kits, MACI implants, MACI Arthro instruments, Epicel grafts, and NexoBrid following the five-step model in Accounting Standards Codification 606, Revenue Recognition.
MACI Biopsy Kits
MACI biopsy kits are sold directly to hospitals and ambulatory surgical centers based on contracted rates set forth in an approved contract or sales order. The Company recognizes MACI kit revenue upon delivery of the biopsy kit, at which time the customer (the facility) is in control of the kit. The kit is used by the treating surgeon to provide a sample of cartilage tissue to the Company, which can later be used to manufacture a MACI implant. The ordering of the kit does not obligate the Company to manufacture an implant nor does the receipt of the cartilage tissue by the Company from the customer following biopsy. The customer’s order of an implant is separate from the process of ordering the biopsy kit. Therefore, the sale of the biopsy kit and any subsequent sale of an implant are distinct contracts and are accounted for separately.
MACI Arthro Instruments
MACI Arthro instruments are sold directly to hospitals and ambulatory surgical centers based upon rates set forth in price lists. The Company recognizes revenue from the sale of MACI Arthro instruments upon delivery of the instruments, at which time the customer (the facility) is in control of the instruments. MACI Arthro instruments can be used by an orthopedic surgeon to deliver MACI to a treated patient using an arthroscopic approach. The customer’s order of a MACI implant is separate from the process of ordering the MACI Arthro instruments. Therefore, the sale of the MACI Arthro instruments and any sale of an implant are distinct and are accounted for separately.
MACI Implants
The Company contracts withtwo specialty pharmacies, Orsini Pharmaceutical Services, Inc. (“Orsini”) and AllCare Plus Pharmacy, Inc. (“AllCare”) to distribute MACI in a manner in which the Company retains the credit and collection risk from the end customer. The Company pays each specialty pharmacy a fee in each instance when it dispenses MACI for use in treating a patient. Both Orsini and AllCare perform collection activities to collect payment from customers. In addition, the Company sells MACI directly to hospitals pursuant to an agreed upon purchase order and to a distributor, DMS Pharmaceutical Group, Inc. (“DMS”) at a contracted rate for the treatment of patients at military facilities throughout the U.S. The Company engages a third party to provide services in connection with a patient support program to manage patient cases and to ensure that complete and correct billing information is provided to the insurers and hospitals.
Prior authorization and confirmation of coverage level by the patient’s private insurance plan, hospital or government payer is a prerequisite to the shipment of a MACI implant to a patient. The Company recognizes product revenue from sales of all MACI implants upon delivery at which time the customer obtains control of the implant and the claim is billable. The total consideration that the Company expects to collect in exchange for MACI implants (the “Transaction Price”) may be fixed or variable. Direct sales to hospitals or distributors are recorded at a contracted price, and there are typically no forms of variable consideration.
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When the Company sells MACI through its specialty pharmacies, the Company is typically reimbursed by a third-party insurer or government payer, subject to a patient co-pay amount. Reimbursements from third-party insurers and government payers vary by patient and payer and are based on either contracted rates, publicly available rates, fee schedules or past payer precedents. Net product revenue is recognized net of estimated contractual allowances, which considers historical collection experience from both the payer and patient, denial rates and the terms of the Company’s contractual arrangements. The Company estimates expected collections for these transactions using the portfolio approach. The Company records a reduction to revenue at the time of sale for its estimate of the amount of consideration that will not be collected. In addition, potential credit risk exposure has been evaluated for the Company’s accounts receivable in accordance with ASC 326, Financial Instruments - Credit Losses. The Company assesses risk and determines a loss percentage by pooling accounts receivable based on similar risk characteristics. The loss percentage is calculated through the use of forecasts that are based on current and historical economic and financial information. This loss percentage was applied to the accounts receivables as of December 31, 2024. The total allowance for uncollectible consideration was $5.4 million and $5.6 million as of December 31, 2024, and 2023, respectively. Changes to the estimate of the amount of consideration that will not be collected could have a material impact on the revenue recognized. A 50 basis points change to the estimated uncollectible percentage could result in an approximately $0.5 million decrease or increase in the revenue recognized for the year ended December 31, 2024.
Changes in estimates of the Transaction Price are recorded through revenue in the period in which such change occurs. Changes in estimates related to prior periods are shown in the Revenue by Product and Customer table below and relate primarily to changes in the initial expected reimbursement or collection expectation upon completion of the billing claims process for MACI implants that occurred in a prior year.
Epicel
The Company sells Epicel directly to hospitals and burn centers based on contracted rates stated in an approved contract or purchase order. Similar to MACI, there is no obligation to manufacture Epicel grafts upon receipt of a skin biopsy, and Vericel has no contractual right to receive payment until the product is delivered to the hospital. The Company recognizes product revenue from sales of Epicel upon delivery to the hospital, at which time the customer is in control of the Epicel grafts and the claim is billable to the hospital.
The Company entered into exclusive license and supply agreements with MediWound in May 2019, pursuant to which MediWound will manufacture and supply NexoBrid on a unit price basis, which may be increased pursuant to the terms of the agreements.
In December 2022, the FDA approved a BLA for NexoBrid, granting a license for its commercial use in the U.S. NexoBrid is a topically-administered biological orphan product containing proteolytic enzymes, which is indicated for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. In August 2024, the FDA additionally approved NexoBrid for pediatric use.
The Company sells NexoBrid to specialty distributors. These customers subsequently resell NexoBrid to hospitals and burn centers. Product revenue is recorded net of reserves for specialty distributor fees, prompt payment or other discounts and allowances for returns, as applicable. The Company recognizes product revenue from sales of NexoBrid when the specialty distributors take control of the product, which typically occurs upon delivery to the specialty distributors.
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Revenue by Product and Customer
The following table and descriptions below show the products from which the Company generated its revenue for the periods indicated:
| Year Ended December 31, | |||
|---|---|---|---|
| Revenue by product (in thousands) | 2024 | 2023 | 2022 |
| MACI implants, kits, and instruments | |||
| Implants based on contracted rate sold through a specialty pharmacy (a) | $141,806 | $105,948 | $81,388 |
| Implants subject to third party reimbursement sold through a specialty pharmacy (b) | 15,058 | 22,203 | 18,695 |
| Implants sold direct based on contracted rates (c) | 31,217 | 27,484 | 24,261 |
| Implants sold direct subject to third-party reimbursement (d) | 4,603 | 4,921 | 3,499 |
| Biopsy kits and instruments - direct bill | 2,096 | 2,087 | 2,090 |
| Change in estimates related to prior periods (e) | 2,529 | 2,157 | 2,034 |
| Total MACI implants, kits, and instruments | 197,309 | 164,800 | 131,967 |
| Epicel | |||
| Direct bill (hospital) | 36,623 | 31,574 | 31,731 |
| NexoBrid (f) | 3,292 | 1,142 | 667 |
| Total revenue | $237,224 | $197,516 | $164,365 |
| (a) Represents implants sold through Orsini and AllCare whereby such specialty pharmacies have a direct contract with the underlying insurance provider. The amount of reimbursement is based on contracted rates at the time of sale supported by the pharmacy’s direct contracts. | |||
| (b) Represents implants sold through Orsini and AllCare whereby such specialty pharmacy does not have a direct contract with the underlying payer and are subject to third-party reimbursement. The amount of reimbursement is established based on publicly available rates, fee schedules or past payer precedents. | |||
| (c) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. Also represents direct sales under a contract to specialty distributor DMS. | |||
| (d) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. The payment terms are subject to third-party reimbursement from an underlying insurance provider. | |||
| (e) Primarily represents changes in estimates related to implants sold through Orsini or AllCare and relate to changes to the initial expected reimbursement or collection expectations upon completion of the billing claims process. The change in estimates is a result of additional information, changes in collection expectations or actual cash collections received in the current period. | |||
| (f) Represents U.S. commercial revenue of NexoBrid for the years ended December 31, 2024 and 2023. In the year ended December 31, 2022, represents revenue based on a percentage of gross profits for sales of NexoBrid to the U.S. Biomedical Advanced Research and Development Authority (“BARDA”), pursuant to the license agreement between the Company and MediWound. | |||
Concentration of Credit Risk
The Company’s total revenue and accounts receivable concentrations from a single customer consisted of the following:
| For the year ended and as of | Revenue | Accounts Receivable |
|---|---|---|
| December 31, 2023 | 11% | 13% |
| December 31, 2024 | 11% | 10% |
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- Selected Balance Sheet Components
Inventory
Inventory consisted of the following:
| December 31, | ||
|---|---|---|
| (In thousands) | 2024 | 2023 |
| Raw materials | $12,827 | $11,348 |
| Work-in-process | 1,571 | 1,210 |
| Finished goods | 2,975 | 529 |
| Total inventory | $17,373 | $13,087 |
Property and Equipment
Property and Equipment, net consisted of the following:
| December 31, | ||
|---|---|---|
| (In thousands) | 2024 | 2023 |
| Machinery and equipment | $12,161 | $5,562 |
| Furniture, fixtures and office equipment | 5,109 | 1,731 |
| Computer equipment and software | 12,318 | 9,116 |
| Leasehold improvements | 77,990 | 14,901 |
| Construction in process | 22,482 | 32,531 |
| Total property and equipment, gross | 130,060 | 63,841 |
| Less accumulated depreciation | (26,899) | (22,206) |
| Total property and equipment, net | $103,161 | $41,635 |
Depreciation expense for the years ended December 31, 2024, 2023 and 2022 was $4.9 million, $4.0 million and $4.0 million, respectively.
Intangible Assets
Intangible assets, net consisted of the following:
| December 31, 2024 · December 31, 2023 | ||||||||
|---|---|---|---|---|---|---|---|---|
| (In thousands) | Useful Life (in years) | Amortization Method | Cost | Accumulated Amortization | Net | Cost | Accumulated Amortization | Net |
| NexoBrid license | 12 | Straight-line | $7,500 | $(1,250) | $6,250 | $7,500 | $(625) | $6,875 |
Amortization expense for the years ended December 31, 2024 and 2023 was $0.6 million and $0.6 million, respectively. There wasno amortization expense recognized during theyear ended December 31, 2022. The NexoBrid intangible asset is amortized to cost of product sales.
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Future amortization expense of intangible assets as of December 31, 2024 is estimated to be as follows:
| (In thousands) | Amount |
|---|---|
| 2025 | $625 |
| 2026 | 625 |
| 2027 | 625 |
| 2028 | 625 |
| 2029 | 625 |
| Thereafter | 3,125 |
| Total | $6,250 |
Accrued Expenses
Accrued Expenses consisted of the following:
| December 31, | ||
|---|---|---|
| (In thousands) | 2024 | 2023 |
| Bonus related compensation | $10,313 | $9,757 |
| Employee related accruals | 3,269 | 3,503 |
| Insurance reimbursement-related liabilities | 3,159 | 3,591 |
| Other accrued expenses | 324 | 364 |
| Total accrued expenses | $17,065 | $17,215 |
- Leases
The Company leases facilities in Ann Arbor, Michigan, Cambridge, Massachusetts and Burlington, Massachusetts. The Ann Arbor facility includes office space, and the Cambridge facility includes clean rooms, laboratories for MACI and Epicel manufacturing and office space. The Company also leases offsite warehouse space and certain equipment.
On January 28, 2022, the Company entered into a lease agreement (as amended, the “Burlington Lease”) to lease approximately 126,000 square feet of manufacturing, laboratory and office space in Burlington, Massachusetts (the “Premises”), which has been under construction. The Burlington facility is substantially complete, and the Company is currently utilizing the facility’s office space. The remaining tenant improvements to the manufacturing suites and related equipment remain ongoing and will be placed in service when they are ready for their intended uses. Once validated, the facility’s manufacturing component will eventually become the primary manufacturing facility for MACI and Epicel.
In April 2023, in connection with the Burlington Lease, the Company entered into a construction escrow agreement (the “Construction Escrow Agreement”) with the facility’s landlord and an escrow agent. Pursuant to the terms of the Construction Escrow Agreement, in April 2023, the Company began funding, into an escrow account maintained by the escrow agent, a portion of its share of tenant improvement construction costs at the facility, which are designated as restricted cash. At the same time, the facility’s landlord began funding a portion of its tenant improvement allowance through a separate escrow account. The Company funded the remaining 50% of its required cost amount, or approximately $28.3 million, with cash on hand, pursuant to the Construction Escrow Agreement in April 2024.
The term of the Burlington Lease began on June 1, 2023 (the “Commencement Date”), when the Company gained control of and commenced tenant improvement work at the Premises. The Company’s obligation to pay rent for the Premises began on July 1, 2024 (the “Rent Commencement Date”). The initial term of the Lease is 144 months following the Rent Commencement Date. The Company has aone-time option to extend the term of the Lease for an additional 10 years, exercisable under certain conditions and at a market rate determined in accordance with the Burlington Lease.
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The annual base rent of the Burlington Lease is initially $57 per square foot per year, subject to annual increases of 2.5%. Monthly contractual payments are expected to range from $0.6 million to $0.8 million. Additionally, the Company is responsible for reimbursing the landlord for the Company’s share of the Premises’ property taxes and certain other operating expenses. The Burlington Lease also provides for a tenant improvement allowance from the landlord in an amount equal to $200 per square foot of the Premises, or approximately $24.4 million. The tenant improvement allowance has been and continues to be used towards the design and construction of the tenant improvements made to the Premises, subject to the terms set forth in the Burlington Lease.
The Company was not involved in the initial construction of the core and shell of the building. On June 1, 2023, the Company gained control of the Premises to begin construction of its tenant improvements. As such, the corresponding right-of-use asset and lease liability of $35.5 million was recorded on the Company’s consolidated balance sheet. As there was not an implicit rate within the lease available, the Company estimated the incremental borrowing rate of 7.7%, based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. The lease term of 13.1 years does not include the lease extension option, as the Company is not reasonably certain to exercise that option. The Company has determined that certain improvements to the Premises are landlord-owned improvements and costs incurred for these improvements are accounted for as a variable lease payment. In the years ended December 31, 2024 and 2023, the Company recorded a right-of-use asset related to landlord-owned improvements incurred of approximately $3.6 million and $2.0 million, respectively.
In January 2022, in connection with the execution of the Burlington Lease, the Company issued a letter of credit collateralized by cash deposits of approximately $6.0 million. Subsequent to the execution of the Revolving Credit Agreement on July 29, 2022 (see Note 8, “Revolving Credit Agreement” for further details), the letter of credit is issued under the sub-facility limit of the Revolving Credit Agreement. Such letter of credit shall be reduced to approximately $4.2 million and $1.8 million at the conclusion of the third and sixth lease years, respectively, provided certain conditions set forth in the Burlington Lease are satisfied.
For the year ended December 31, 2024, lease expense of $0.3 million, and for the years ended December 31, 2023 and 2022, lease expense of less than $0.1 million, was recorded related to short-term leases. For the years ended December 31, 2024, 2023 and 2022, the Company recognized $12.7 million, $10.3 million and $6.9 million, respectively, of operating lease expense. For the years ended December 31, 2024, 2023 and 2022, the Company recognized less than $0.1 million of financing lease expense.
Operating and finance lease assets and liabilities are as follows:
| December 31, | ||||
|---|---|---|---|---|
| (In thousands) · Classification · 2024 · 2023 | ||||
| Assets | ||||
| Operating | Right-of-use assets | $70,098 | $73,462 | |
| Finance | Property and equipment, net | 686 | — | |
| Total leased assets | $70,784 | $73,462 | ||
| Liabilities | ||||
| Current | ||||
| Operating | Current portion of operating lease liabilities | $9,257 | $6,187 | |
| Finance | Other current liabilities | 116 | — | |
| Non-current | ||||
| Operating | Operating lease liabilities | 89,593 | 81,856 | |
| Finance | Other long-term liabilities | 570 | — | |
| Total leased liabilities | $99,536 | $88,043 | ||
Cash received for amounts included in the measurement of the Company’s operating lease liabilities was $1.4 million for the year ended December 31, 2024. Cash paid for amounts included in the measurement of the Company’s operating lease liabilities was $1.7 million and $5.3 million for the years ended December 31, 2023 and 2022, respectively.
Future minimum lease payments under non-cancellable leases as of December 31, 2024 are as follows:
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| (In thousands) | Operating Leases | Finance Leases | Total |
|---|---|---|---|
| 2025 | $13,677 | $116 | $13,793 |
| 2026 | 13,969 | 116 | 14,085 |
| 2027 | 14,351 | 116 | 14,467 |
| 2028 | 14,743 | 116 | 14,859 |
| 2029 | 15,146 | 116 | 15,262 |
| Thereafter | 73,339 | 219 | 73,558 |
| Total lease payments | $145,225 | $799 | $146,024 |
| Less: tenant improvement allowances | (4,419) | — | (4,419) |
| Less: interest | (41,956) | (113) | (42,069) |
| Present value of lease liabilities | $98,850 | $686 | $99,536 |
Lease terms and discount rates are as follows:
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Weighted-average remaining lease term (years) | ||
| Operating leases | 9.7 | 10.0 |
| Finance leases | 6.9 | — |
| Weighted-average discount rate | ||
| Operating leases | 6.9% | 6.8% |
| Finance leases | 5.0% | —% |
- Investments
Marketable debt securities held by the Company are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities, and carried at fair value in the accompanying consolidated balance sheets on a settlement date basis. The following tables summarize the gross unrealized gains and losses of the Company’s marketable securities:
| Gross Unrealized | ||||||
|---|---|---|---|---|---|---|
| (In thousands) · Amortized Cost · Gains · Losses · Credit Losses · Estimated Fair Value | ||||||
| Commercial paper | $1,953 | $1 | $(1) | $— | $1,953 | |
| Corporate notes | 71,733 | 117 | (87) | — | 71,763 | |
| U.S. government agency bonds | 7,883 | 4 | (30) | — | 7,857 | |
| $81,569 | $122 | $(118) | $— | $81,573 | ||
| Classified as: | ||||||
| Short-term investments | $41,693 | |||||
| Long-term investments | 39,880 | |||||
| $81,573 | ||||||
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| Gross Unrealized | ||||||
|---|---|---|---|---|---|---|
| (In thousands) · Amortized Cost · Gains · Losses · Credit Losses · Estimated Fair Value | ||||||
| Commercial paper | $3,638 | $1 | $— | $— | $3,639 | |
| Corporate notes | 47,228 | — | (69) | — | 47,159 | |
| U.S. government securities | 983 | — | — | — | 983 | |
| U.S. government agency bonds | 14,003 | — | (32) | — | 13,971 | |
| $65,852 | $1 | $(101) | $— | $65,752 | ||
| Classified as: | ||||||
| Short-term investments | $40,469 | |||||
| Long-term investments | 25,283 | |||||
| $65,752 | ||||||
There have beenno impairments of the Company’s assets measured and carried at fair value during the years ended December 31, 2024 or 2023.
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- Stock-Based Compensation
Stock Option, Restricted Stock Units and Equity Incentive Plans
The Company has historically had various stock incentive plans and agreements that provide for the issuance of non-qualified and incentive stock options and restricted stock units as well as other equity awards. Such awards may be granted by the Company’s Board of Directors to certain of the Company’s employees, directors and consultants.
Options granted to employees and non-employees under these plans expire no later thanten years from the date of grant. Options and restricted stock units generally become exercisable or vest over afour year period (other than options and restricted stock units awarded annually to non-employee directors, which generally vest overone year, and options and restricted stock units awarded to non-employee directors upon initial appointment to the Vericel Board of Directors, which generally vest over athree year period), under a graded-vesting methodology for stock options and annually on the anniversary grant date for restricted stock units, following the date of grant. The Company generally issues new shares upon the exercise of stock options or vesting of restricted stock units.
The Vericel Corporation 2022 Omnibus Incentive Plan (“2022 Plan”) was approved on April 27, 2022, and provides incentives through the grant of stock options, stock appreciation rights, restricted stock awards and restricted stock units. The exercise price of stock options granted under the 2022 Plan shall not be less than the fair market value of the Company’s common stock on the date of grant. The 2022 Plan replaced the 1992 Stock Option Plan, the 2001 Stock Option Plan, the Amended and Restated 2004 Equity Incentive Plan, the 2009 Second Amended and Restated Omnibus Incentive Plan, the 2017 Omnibus Incentive Plan, and the Amended and Restated 2019 Omnibus Incentive Plan (collectively the “Prior Plans”), and no new grants have been granted under the Prior Plans after approval of the 2022 Plan. However, the expiration or forfeiture of options previously granted under the Prior Plans will increase the number of shares available for issuance under the 2022 Plan.
As of December 31, 2024, there were 1,189,503 shares available for future grant under the 2022 Plan.
Stock Compensation Expense
Non-cash stock-based compensation expense (service-based stock options, restricted stock units and employee stock purchase plan) is summarized in the following table:
| Years Ended December 31, | |||
|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2022 |
| Cost of product sales | $3,911 | $2,970 | $3,630 |
| Research and development | 4,068 | 3,705 | 5,261 |
| Selling, general and administrative | 28,516 | 25,650 | 28,292 |
| Total non-cash stock-based compensation expense | $36,495 | $32,325 | $37,183 |
Service-Based Stock Options
The fair value of each service-based stock option grant for the reported periods is estimated on the date of the grant using the Black-Scholes option-pricing model using the assumptions noted in the following table:
| Year Ended December 31, | |||
|---|---|---|---|
| Service-Based Stock Options | 2024 | 2023 | 2022 |
| Expected dividend rate | —% | —% | —% |
| Expected stock price volatility | 57.3 - 62.5% | 62.5 - 66.7% | 63.8 - 75.3% |
| Risk-free interest rate | 3.4 - 4.7% | 3.4 - 4.7% | 1.50 -4.4% |
| Expected life (years) | 5.5 | 5.5 | 5.3 - 6.3 |
| Weighted-average grant date fair value | $28.05 | $18.85 | $19.83 |
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The following table summarizes the activity for service-based stock options for the indicated periods:
| Service-Based Stock Options | Options | Weighted-Average Exercise Price | Weighted-Average Remaining Contractual Term(Years) | Aggregate Intrinsic Value(Thousands) |
|---|---|---|---|---|
| Outstanding at December 31, 2023 | 6,716,686 | $25.85 | 6.2 | $88,387 |
| Granted | 767,037 | 48.49 | ||
| Exercised | (1,544,653) | 14.97 | ||
| Expired | (28,247) | 53.73 | ||
| Forfeited | (146,716) | 42.44 | ||
| Outstanding at December 31, 2024 | 5,764,107 | $31.22 | 6.1 | $137,365 |
| Exercisable at December 31, 2024 | 4,381,393 | $28.38 | 5.4 | $116,951 |
As of December 31, 2024,5,615,834 shares are vested and expected to vest. As of December 31, 2024, there was approximately $18.7 million of total unrecognized compensation cost related to non-vested service-based stock options granted under the 2022 Plan and the Prior Plans. That cost is expected to be recognized over a weighted-average period of 2.6 years.
The total intrinsic value of stock options exercised for the years ended December 31, 2024, 2023, and 2022 was $50.1 million, $7.5 million and $5.4 million, respectively.
Restricted Stock Units
The following table summarizes the activity for restricted stock units for the indicated periods:
| Restricted Stock Units | Number of Restricted Stock Units | Weighted-Average Grant Date Fair Value |
|---|---|---|
| Outstanding at December 31, 2023 | 930,936 | $32.85 |
| Granted | 644,905 | 48.20 |
| Vested | (323,435) | 32.90 |
| Forfeited | (117,145) | 40.18 |
| Unvested at December 31, 2024 | 1,135,261 | $40.80 |
The weighted-average grant-date fair value of restricted stock units granted during the years ended December 31, 2024, 2023, and 2022 was $48.20, $30.36 and $33.71, respectively.
At December 31, 2024 the total unrecognized compensation cost related to the restricted stock units was $27.0 million, and the weighted-average period over which that cost is expected to be recognized was 2.7 years. The total fair value of restricted stock units vested in the years ended December 31, 2024 and 2023 was $15.7 million and $6.8 million respectively.
Employee Stock Purchase Plan
Employees are able to purchase stock under the ESPP. The ESPP allows for the issuance of an aggregate of 1.0 million shares of common stock of which 889,342 have been issued since the inception of the benefit in 2015. Participation in this plan is available to substantially all employees. The ESPP is a compensatory plan accounted for under the expense recognition provisions of the share-based payment accounting standards. Compensation expense is recorded based on the fair market value of the purchase options at the grant date, which corresponds to the first day of each purchase period and is amortized over the purchase period.
- Revolving Credit Agreement
On July 29, 2022, the Company, as borrower, entered into a $150.0 million five-year senior secured revolving credit agreement by and among the Company, the other loan parties thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as the administrative agent (the “Revolving Credit Agreement”). The Revolving Credit Agreement includes a $15.0 million sub-facility for the issuance of letters of credit, of which the Company is utilizing approximately $6.2 million. Amounts available under the Revolving Credit Agreement are for the working capital needs and other general corporate
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purposes of the Company. The Company incurred and capitalized approximately $1.1 million of debt issuance costs related to the Revolving Credit Agreement.
Outstanding borrowings under the Revolving Credit Agreement bear interest, with pricing based from time to time at the Company’s election at (i) the Secured Overnight Financing Rate (“SOFR”) plus 0.10% plus a spread ranging from 1.25% to 2.50% as determined by the Company’s Total Net Leverage Ratio (as defined in the Revolving Credit Agreement) or (ii) the alternative base rate (as defined in the Revolving Credit Agreement) plus a spread ranging from 0.25% to 1.50% as determined by the Company’s Total Net Leverage Ratio. The Revolving Credit Agreement also includes a commitment fee, which ranges from 0.20% to 0.25% as determined by the Company’s Total Net Leverage Ratio.
The Company is permitted to voluntarily prepay borrowings under the Revolving Credit Agreement, in whole or in part, without premium or penalty. On any business day on which the total amount of outstanding Revolving Loans (as defined in the Revolving Credit Agreement) and letters of credit exceeds the total Revolving Commitments (as defined in the Revolving Credit Agreement), the Company must prepay the Revolving Loans in an amount equal to such excess. As of December 31, 2024, there areno outstanding borrowings under the Revolving Credit Agreement.
The Revolving Credit Agreement contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds. The Revolving Credit Agreement requires the Company to be in quarterly compliance, measured on a trailing four quarter basis, with a financial covenant. The maximum Total Net Leverage Ratio (as defined in the Revolving Credit Agreement is 3.50 to 1.00. The Company may elect to increase the maximum Total Net Leverage Ratio to 4.00 to 1.00 for a period of four consecutive quarters in connection with a Permitted Acquisition (as defined in the Revolving Credit Agreement).
The Revolving Credit Agreement contains usual and customary restrictions on the ability of the Company and its subsidiaries to: (i) incur additional indebtedness (ii) create liens; (iii) consolidate, merge, sell or otherwise dispose of all, or substantially all, of its assets; (iv) sell certain assets; (v) pay dividends on, repurchase or make distributions in respect of capital stock or make other restricted payments; (vi) make certain investments; (vii) repay subordinated indebtedness prior to stated maturity; and (viii) enter into certain transactions with its affiliates.
Obligations under the Revolving Credit Agreement are secured by first priority liens over substantially all of the assets of Vericel Corporation, excluding certain subsidiaries (subject to customary exclusions set forth in the Revolving Credit Agreement and the other transaction documents).
- Net Income (Loss) Per Common Share
A summary of net income (loss) per common share is presented below:
| Year Ended December 31, | |||
|---|---|---|---|
| (Amounts in thousands, except per share amounts) | 2024 | 2023 | 2022 |
| Net income (loss) | $10,362 | $(3,182) | $(16,709) |
| Basic weighted-average common shares outstanding | 48,848 | 47,590 | 47,130 |
| Effect of dilutive stock options and restricted stock units | 2,831 | — | — |
| Diluted weighted-average common shares outstanding | 51,679 | 47,590 | 47,130 |
| Basic income (loss) per common share | $0.21 | $(0.07) | $(0.35) |
| Diluted income (loss) per common share | $0.20 | $(0.07) | $(0.35) |
| Anti-dilutive shares excluded from diluted net loss per common share: | |||
| Stock options | 1,887 | 6,717 | 6,609 |
| Restricted stock units | 23 | 931 | 648 |
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- Fair Value Measurements
The Company’s fair value measurements are classified and disclosed in one of the following three categories:
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability;
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The commercial paper, corporate notes, U.S. government securities, and U.S. government agency bonds are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The deferred compensation plan liabilities are recorded at the value of the amount owed to the plan participants, with changes in value recognized as compensation expense. The calculation of the deferred compensation plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants. There were no transfers into or out of Level 3 from December 31, 2022 to December 31, 2024.
The following table summarizes the valuation of the Company’s financial assets and liabilities that are measured at fair value on a recurring basis:
| December 31, 2024 · December 31, 2023 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Fair value measurement category | Fair value measurement category | |||||||
| (In thousands) | Total | Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 |
| Assets: | ||||||||
| Money market funds | $43,307 | $43,307 | $— | $— | $34,672 | $34,672 | $— | $— |
| Commercial paper (a) | 1,953 | — | 1,953 | — | 4,876 | — | 4,876 | — |
| Corporate notes | 71,763 | — | 71,763 | — | 47,159 | — | 47,159 | — |
| U.S. government agency bonds (a) | 7,857 | — | 7,857 | — | 13,971 | — | 13,971 | — |
| U.S. government securities (a) | 16,150 | — | 16,150 | — | 24,874 | — | 24,874 | — |
| Total assets | $141,030 | $43,307 | $97,723 | $— | $125,552 | $34,672 | $90,880 | $— |
| Liabilities: | ||||||||
| Deferred compensation plan liabilities | $306 | $— | $306 | $— | $100 | $— | $100 | $— |
| Total liabilities | $306 | $— | $306 | $— | $100 | $— | $100 | $— |
(a) Approximately $16.2 million of U.S. government securities as of December 31, 2024, and approximately $23.9 million of U.S. government securities and $1.2 million of commercial paper as of December 31, 2023, had an original maturity of 90 days or less and were recorded as a cash equivalent.
The fair values of the cash equivalents and marketable securities are based on observable market prices. The Company’s accounts receivables, accounts payable and accrued expenses are valued at cost which approximates fair value.
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- Income Taxes
The components of loss before income taxes are summarized as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2024 | 2023 | 2022 |
| U.S. | $10,580 | $(2,381) | $(15,912) |
| Foreign | (70) | 13 | (76) |
| Income (loss) before income taxes | $10,510 | $(2,368) | $(15,988) |
A reconciliation of income taxes computed using the U.S. federal statutory rate to the taxes reported in the consolidated statements of operations is as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2024 | 2023 | 2022 |
| Income (loss) before income taxes | $10,510 | $(2,368) | $(15,988) |
| Federal statutory rate | 21% | 21% | 21% |
| Taxes computed at federal statutory rate | 2,207 | (497) | (3,357) |
| State and local income taxes | 381 | (389) | (630) |
| Nondeductible stock-based compensation | (6,547) | (586) | 1,168 |
| Federal and state rate change | 1,090 | (704) | 574 |
| Research and orphan drug credits | (156) | 362 | (644) |
| Other | 402 | 162 | 267 |
| Deferred tax adjustment | 7,374 | — | — |
| Change in valuation allowance | (4,603) | 2,466 | 3,343 |
| Reported income taxes | $148 | $814 | $721 |
Deferred tax assets (liabilities) consist of the following:
| Year Ended December 31, | ||
|---|---|---|
| (In thousands) | 2024 | 2023 |
| Deferred tax assets: | ||
| Net operating loss carryforwards | $15,481 | $4,505 |
| Employee benefits and stock-based compensation | 18,606 | 24,812 |
| Research and development costs | 4,778 | 5,176 |
| Intangible assets | 786 | 962 |
| Operating lease liabilities | 20,664 | 20,849 |
| Inventory reserve | 2,540 | 3,570 |
| Tax credit carryforward | 10,937 | 10,781 |
| Other, net | 3 | 12 |
| Total deferred tax assets | 73,795 | 70,667 |
| Less: valuation allowance | (45,153) | (49,755) |
| Total net deferred tax assets | 28,642 | 20,912 |
| Deferred tax liabilities: | ||
| Right-of-use assets | (18,056) | (19,296) |
| Property and equipment, net | (10,586) | (1,616) |
| Total net deferred tax liabilities | (28,642) | (20,912) |
| Net deferred tax assets and liabilities | $— | $— |
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As of December 31, 2024, the Company had U.S. federal net operating loss carryforwards of $56.6 million, of which $10.9 million begin to expire in 2033 and the remainder do not expire but are subject to 80% limitation. As of December 31, 2024, the Company had state net operating loss carryforwards of $54.9 million that begin to expire in 2027. The projected annual limitation on the use of the net operating losses that existed prior to September 17, 2014 resulting from the Company’s change in control in 2014 per Section 382 of the Internal Revenue Code is $0.8 million. As a result, a significant portion of the net operating losses and tax credit carryforwards will expire prior to their utilization, regardless of the level of future profitability. As of December 31, 2024, the Company’s U.S. federal tax credit carryforwards available to offset future profits are $10.9 million. These credit carryforwards expire between 2027 and 2044.
In accordance with the accounting guidance for income taxes, the Company estimates whether recoverability of its deferred tax assets is “more likely than not”, based on forecasts of taxable income in the related tax jurisdictions. In this estimate, the Company uses historical results, projected future operating results based upon approved business plans, eligible carry forward periods, tax planning opportunities and other relevant considerations. Based on these factors, including historical losses incurred by the Company, a full valuation allowance for the deferred tax assets, including the deferred tax assets for the aforementioned net operating losses and credits has been provided, since they are not more likely than not to be realized. If sufficient positive evidence exists in future periods to support a release of some or all of the valuation allowance, such a release would likely have a material impact on the Company’s results of operations. The change in the valuation allowance was a decrease of $4.6 million and an increase of $2.5 million for the years ended December 31, 2024 and 2023, respectively.
The Company assesses uncertain tax positions in accordance with the guidance for accounting for uncertain tax positions. This pronouncement prescribes a recognition threshold and measurement methodology for recording within the consolidated financial statements uncertain tax positions taken, or expected to be taken, in the Company’s income tax returns. To the extent the uncertain tax positions do not meet the “more likely than not” threshold, the Company derecognizes such positions. To the extent the uncertain tax positions meet the “more likely than not” threshold, the Company measures and records the highest probable benefit, and establishes appropriate reserves for benefits that exceed the amount likely to be sustained upon examination. The Company currently has not recorded any uncertain tax positions and does not anticipate that unrecognized tax benefits will significantly increase or decrease within the next twelve months.
The Company files U.S. federal and state income tax returns with varying statutes of limitations. During the year ended December 31, 2020, examinations by U.S. tax authorities were completed for 2017 and 2018. The Company is currently under examination by U.S. tax authorities for the tax year ended December 31, 2021. Due to the Company’s net operating loss carryforwards, federal income tax returns from incorporation are still subject to examination. The Company files in several state tax jurisdictions and is subject to examination in years ranging from incorporation to 2024.
- Employee Benefit Plans
401(k) Plan
The Company has a 401(k) savings plan that allows participating employees to contribute a portion of their salary, subject to annual limits and minimum qualifications. The Board may, at its sole discretion, approve Company matching contributions to the plan. The Company made contributions of $1.3 million, $1.2 million and $1.1 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Non-Qualified Deferred Compensation Plan
The Company has a deferred compensation plan which is a non-qualified deferred compensation plan that is intended to comply with Section 409A of the Code, for its non-employee directors, a select group of executive officers, senior management and highly compensated employees of the Company. Eligible employees may elect to contribute up to 75% of their annual base salary and 100% of their annual bonus, restricted stock units and/or director fees earned to the deferred compensation plan, and such employee contributions are 100% vested. The calculation of the deferred compensation plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants. The deferred compensation plan obligations are payable in cash upon retirement, termination of employment and/or certain other times in lump-sum distribution or in installments, as elected by the participant in accordance with the plan. As of December 31, 2024 the deferred compensation plan liabilities total $0.3 million and are recorded in other long-term liabilities.
- NexoBrid License and Supply Agreements
On May 6, 2019, the Company entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. NexoBrid is a topically-administered biological orphan product containing proteolytic enzymes,
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for which the FDA approved a BLA in December 2022 permitting the product’s use for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. Subsequently, in August 2024, the FDA approved a supplemental BLA expanding NexoBrid’s indication to include pediatric patients.
Pursuant to the terms of the license agreement, following the FDA approval of NexoBrid, MediWound transferred the BLA to Vericel. NexoBrid is approved in the European Union (“EU”) and other international markets and has been designated as an orphan biologic in the U.S., EU and other international markets.
In May 2019, the Company paid MediWound $17.5 million in consideration for the license, which was recorded as research and development expense during 2019. The FDA’s December 2022 approval of NexoBrid resulted in the achievement of a $7.5 million regulatory milestone payment pursuant to the terms of the license agreement. The Company recorded the $7.5 million milestone for the licensing rights to commercially sell NexoBrid in the U.S. as an intangible asset as of December 31, 2022 (see Note 4, “Selected Balance Sheet Components” for further details). The $7.5 million milestone payment was paid to MediWound in February of 2023.
Additionally, the Company is obligated to pay MediWound up to $125.0 million, which is contingent upon meeting certain sales milestones. The first sales milestone payment of $7.5 million would be triggered when annual net sales of NexoBrid or improvements to NexoBrid in North America exceed $75.0 million. As of December 31, 2024, the sales milestone payments are not yet probable and therefore, not recorded as a liability. The Company pays MediWound tiered royalties on net sales ranging from mid-high single-digit to mid-teen percentages, subject to customary reductions. Pursuant to the terms of the Company’s supply agreement with MediWound, MediWound is manufacturing, and will continue to manufacture NexoBrid for the Company on a unit price basis, which may be increased pursuant to the terms of the supply agreement. MediWound is obligated to supply the Company with NexoBrid for sale in North America on an exclusive basis for the first five years of the term of the supply agreement. Under the supply agreement, the Company possesses the option to extend the initial term of the agreement by an additional 24 months, which it did in May 2022. After the initial term, the Company may extend the supply agreement on an annual basis for up to 10 additional years, at its sole discretion. Under the supply agreement, the Company is permitted to establish an alternate source of supply in certain circumstances, including the event of a supply failure.
Additionally, beginning in 2020, BARDA procured quantities of NexoBrid from MediWound for use as a medical countermeasure in the event of a mass casualty emergency in the U.S. involving thermal burns. The initial, quarterly, procurement of NexoBrid by BARDA under its agreement with MediWound was completed during the third quarter of 2022. As a part of BARDA’s commitment to procure NexoBrid, the Company received a percentage of gross profit for sales directly to BARDA. As of December 31, 2024, the Company did not hold a direct contract or distribution agreement with BARDA, or take title to the product procured by BARDA.
- Commitments and Contingencies
From time-to-time, the Company could be a party to various legal proceedings arising in the ordinary course of business. The costs and outcome of litigation, regulatory, investigatory or other proceedings cannot be predicted with certainty, and some lawsuits, claims, actions or proceedings may be disposed of unfavorably to the Company and could have a material adverse effect on the Company’s results of operations or financial condition. In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations. If a matter is both probable to result in material liability and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible material loss or range of loss. If such loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements.
As of December 31, 2024, the Company had no material ongoing litigation in which the Company was a party or any material ongoing regulatory or other proceedings and had no knowledge of any investigations by government or regulatory authorities in which the Company is a target that could have a material adverse effect on its current business.
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Manufacturing and Supply Agreements
Matricel —On July 1, 2023, the Company renewed its long-term supply agreement with Matricel GmbH (“Matricel”) for the supply of ACI-Maix collagen membranes used in the manufacture of MACI (the “Matricel Supply Agreement”). In the event Matricel is unable to supply the membranes, the Company may license the technology and procure the membranes from another source. The Matricel Supply Agreement provides that Matricel shall supply the ACI-Maix membranes exclusively to the Company during the term of the agreement. The Matricel Supply Agreement is effective until December 31, 2030, with an option to extend its term forthree additional years to December 31, 2033. Thereafter, the Matricel Supply Agreement may be renewed for additional three-year periods. Under the terms of the Matricel Supply Agreement, the Company has committed to annual minimum purchase values totaling approximately €12.5 million over theeight-year term.
Manufacture, Supply and Other Agreements — The Company has entered into various agreements relating to the manufacture of its products and the supply of certain components. If the manufacturing or supply agreements expire or are otherwise terminated, the Company may not be able to identify and obtain ancillary materials that are necessary to develop its products and such expiration and termination could have a material effect on the Company’s business.
The Company’s purchase commitments consist of minimum purchase amounts of raw materials and finished goods used in the Company’s cell manufacturing process to manufacture its marketed cell therapy products. In addition, the Company also pays for usage of offsite warehouse space.
Future minimum purchase commitments related to the Company’s contractual obligations are as follows:
| Payments Due by Period | |||||||
|---|---|---|---|---|---|---|---|
| Contractual Obligations (In thousands) | Total | 2025 | 2026 | 2027 | 2028 | 2029 | More than 5 Years |
| Purchase commitments | $15,416 | $6,405 | $1,521 | $1,802 | $1,896 | $1,896 | $1,896 |
| Warehouse operating agreement | 941 | 941 | — | — | — | — | — |
| Total | $16,357 | $7,346 | $1,521 | $1,802 | $1,896 | $1,896 | $1,896 |
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- Segment Information
The Company operates its business primarily in the U.S. inone reportable segment - the research, product development, manufacture and distribution of cellular therapies and specialty biologics for use in the treatment of specific conditions. The Company is managed on a consolidated basis. The accounting policies, as described in Note 2, “Summary of Significant Accounting Policies” apply to the reportable segment.
The Company’s Chief Executive Officer was determined to be the Company’s chief operating decision maker (“CODM”). The CODM reviews and evaluates revenue, expenses and consolidated net income (loss), consistent with what is reported on the consolidated statement of operations, for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.
The Company’s revenues are generated in the U.S. and the Company’s long-lived assets, which consist primarily of property and equipment and right-of use assets, are located in U.S.
In additional to the significant expense categories within the Company’s consolidated statements of operations, see below for disaggregated amounts that comprise selling, general and administrative expenses:
| Year Ended December 31, | |||
|---|---|---|---|
| ( in thousands) | 2024 | 2023 | 2022 |
| Selling and marketing | $82,142 | $69,007 | $60,926 |
| General and administrative | 60,649 | 51,991 | 45,977 |
| Total selling, general and administrative expenses | $142,791 | $120,998 | $106,903 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.