AVITA Medical Inc
For the period ended Mar 31, 2024. Filed May 13, 2024.
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Mar 31, 2024 · Filed May 13, 2024
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Notes to Consolidated Financial Statements (unaudited)
Notes to Consolidated Financial Statements
- The Company
Nature of the Business
AVITA Medical, Inc. and its subsidiaries (collectively, “AVITA Medical”, “we”, “our”, “us”, or “Company”) is a commercial-stage regenerative medicine company transforming the standard of care in wound management and skin restoration with innovative devices. At the forefront of the Company's portfolio is its patented and proprietary RECELL®System (“RECELL System” or “RECELL”), approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects ("FTSD"), and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create an autologous skin cell suspension, Spray-On Skin™ Cells, delivering a transformative solution at the point of care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes.
On January 10, 2024, the Company entered into an exclusive multi-year distribution agreement with Stedical Scientific, Inc.
("Stedical") to commercialize PermeaDerm® Biosynthetic Wound Matrix ("PermeaDerm") in the United States (the "Stedical Agreement"). PermeaDerm is cleared by the FDA as a transparent matrix for use in the treatment of a variety of wound types until healing is achieved. Under the terms of the agreement, the Company holds the exclusive rights to market, sell, and distribute PermeaDerm products, including any future enhancements or modifications, within the United States. The initial term is forfive years, with the option to renew for an additional five years, contingent upon meeting certain minimum requirements.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited Consolidated Financial Statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the Consolidated Financial Statements reflect all adjustments of a normal and recurring nature that are considered necessary for a fair presentation of the results for the interim periods presented. The information included in this quarterly report on Form 10-Q should be read in conjunction with the audited Consolidated Financial Statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year-ended December 31, 2023 filed with the SEC on February 22, 2024 and the Australian Securities Exchange ("ASX") on February 23, 2024 (the “2023 Annual Report").
There have been no changes to the Company’s significant accounting policies as described in the 2023 Annual Report that have had a material impact on the Company’s Consolidated Financial Statements. See the summary of the Company’s significant accounting policies set forth in the notes to its Consolidated Financial Statements included in the 2023 Annual Report.
Principles of Consolidation
The accompanying Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation.
Recent Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the Chief Operating Decision Maker ("CODM") and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective for the Company’s 2023 Annual Report on Form 10-K for the fiscal year ending December 31, 2025, and subsequent interim periods, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
Use of Estimates
The preparation of the accompanying Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts (including estimate of the average selling price for PermeaDerm sales, allowance for credit losses, reserves for inventory excess and obsolescence, carrying value of long-lived assets, the useful lives of long-lived assets, accounting for marketable securities, income taxes, fair value of the debt, fair value of warrants and stock-based compensation) and related disclosures. Estimates have been prepared on the basis of the current and available information. However, actual results could differ from estimated amounts.
Foreign Currency Translation and Foreign Currency Transactions
The financial position and results of operations of the Company’s operating non-U.S. subsidiaries are generally determined using the respective local currency as the functional currency of that subsidiary. Assets and liabilities of these subsidiaries are translated at the exchange rate in effect at each period end. Income statement accounts are translated at the average rate of exchange prevailing during the period. Adjustments arising from the use of differing exchange rates from period to period are included in Other comprehensive gain (loss) in Stockholders’ Equity. Gains and losses resulting from foreign currency transactions are included in earnings in the Consolidated Statement of Operations. Gains and losses resulting from foreign currency transactions were minimal for the three-months ended March 31, 2024 and 2023.
The Company’s non-operating subsidiaries that use the U.S. dollar as their functional currency remeasure monetary assets and liabilities at exchange rates in effect at the end of each period and nonmonetary assets and liabilities at historical rates. Gains and losses resulting from these remeasurements are included in earnings in the Consolidated Statement of Operations. Gains and losses for remeasurement and foreign currency transactions were minimal during the three-months ended March 31, 2024 and 2023.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash held at deposit institutions and cash equivalents. Cash equivalents consist primarily of money market funds. Cash equivalents also includes short-term highly liquid investments with original maturities of three months or less from the date of purchase. The Company holds cash at deposit institutions in the amount of $4.9 million and $10.7 million as of March 31, 2024 and December 31, 2023, respectively. The Company doesnot have cash on deposit denominated in foreign currency in foreign institutions as of March 31, 2024. As of December 31, 2023, the Company had $69,000 of cash on deposit denominated in foreign currencies in foreign institutions. As of March 31, 2024 and December 31, 2023, the Company held cash equivalents in the amount of$12.0 million and $11.4 million, respectively.
Concentrations
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, marketable securities, trade receivables and debt and other liabilities. As of March 31, 2024 and December 31, 2023, substantially all the Company’s cash was deposited in accounts at financial institutions, and amounts exceed federally insured limits and are subject to the risk of bank failure.
As of March 31, 2024 and December 31, 2023, no single commercial customer accounted for more than 10% of net accounts receivable or more than 10% of revenues for the three-months ended March 31, 2024 and 2023.
- Marketable Securities
The following table summarizes the amortized cost and estimated fair values of securities available-for-sale:
| AmortizedCost · GrossUnrealizedHoldingGains · GrossUnrealizedHoldingLosses · CarryingValue | ||||||
|---|---|---|---|---|---|---|
| (in thousands) | ||||||
| Cash equivalents: | ||||||
| Money market funds | $12,018 | $ | - | $ | - | $12,018 |
| Total cash equivalents | $12,018 | $ | - | $ | - | $12,018 |
| Current marketable securities: | ||||||
| U.S. Treasury securities | $51,225 | $11 | $(4) | $51,232 | ||
| Total current marketable securities | $51,225 | $11 | $(4) | $51,232 | ||
| AmortizedCost · GrossUnrealizedHoldingGains · GrossUnrealizedHoldingLosses · CarryingValue | ||||||
|---|---|---|---|---|---|---|
| (in thousands) | ||||||
| Cash equivalents: | ||||||
| Money market funds | $8,427 | $ | - | $ | - | $8,427 |
| U.S. Treasury securities | 2,992 | - | - | 2,992 | ||
| Total cash equivalents | $11,419 | $ | - | $ | - | $11,419 |
| Current marketable securities: | ||||||
| U.S. Treasury securities | $65,145 | $100 | $(3) | $65,242 | ||
| U.S. Government agency obligations | 1,699 | - | (2) | 1,697 | ||
| Total current marketable securities | $66,844 | $100 | $(5) | $66,939 | ||
The maturities of our available-for-sale securities are summarized in the following table using contractual maturities. Actual maturities may differ from contractual maturities due to obligations that are called or prepaid.
| As of March 31, 2024 | As of December 31, 2023 | |||
|---|---|---|---|---|
| (in thousands) | AmortizedCost | CarryingValue | AmortizedCost | CarryingValue |
| Due in one year or less | $51,225 | $51,232 | $66,844 | $66,939 |
Unrealized gains and losses, net of any related tax effects for available-for-sale securities are excluded from earnings and are included in other comprehensive loss and reported as a separate component of stockholders' equity until realized. Realized gains and losses on marketable securities are included in Other income (expense), net, in the accompanying Consolidated Statements of Operations. The Company had net unrealized gains of $7,000 and $95,000 as of March 31, 2024 and December 31, 2023, respectively. The Company didnot have sales of investments during the three-months ended March 31, 2024 and 2023 that resulted in realized gains or losses. As of March 31, 2024, and December 31, 2023, the Company didnot recognize credit losses. The Company has accrued interest income receivable of $182,000 and $227,000 as of March 31, 2024, and December 31, 2023, respectively, in Prepaids and other current assets.
- Fair Value Measurements
ASC 820, Fair Value Measurement, the authoritative guidance on fair value measurements establishes a framework with respect to measuring assets and liabilities at fair value on a recurring basis and non-recurring basis. Under the framework, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as of the measurement date. The framework also establishes a three-tier hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability and are developed based on the best information available in the circumstances. The hierarchy consists of the following three levels:
Level 1: Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date.
Level 2: Inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3: Inputs are unobservable inputs for the asset or liability
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis, based on the three-tier fair value hierarchy:
| (in thousands) · Level 1 · Level 2 · Level 3 · Total | |||||||
|---|---|---|---|---|---|---|---|
| Cash equivalents: | |||||||
| Money market funds | $12,018 | $ | - | $ | - | $12,018 | |
| Total cash equivalents | $12,018 | $ | - | $ | - | $12,018 | |
| Current marketable securities: | |||||||
| U.S. Treasury securities | $ | - | $51,232 | $ | - | $51,232 | |
| Total current marketable securities | $ | - | $51,232 | $ | - | $51,232 | |
| Total marketable securities and cash equivalents | $12,018 | $51,232 | $ | - | $63,250 | ||
| Financial liabilities: | |||||||
| Long-term debt | $ | - | $ | - | $41,301 | $41,301 | |
| Warrant liability | - | - | 4,028 | $4,028 | |||
| Non-qualified deferred compensation plan liability | - | 4,342 | - | $4,342 | |||
| Total financial liabilities | $ | - | $4,342 | $45,329 | $49,671 | ||
| Financial assets: | |||||||
| Corporate-owned life insurance policies | $ | - | $2,880 | $ | - | $2,880 | |
| Total financial assets | $ | - | $2,880 | $ | - | $2,880 | |
| (in thousands) · Level 1 · Level 2 · Level 3 · Total | |||||||
|---|---|---|---|---|---|---|---|
| Cash equivalents: | |||||||
| Money market funds | $8,427 | $ | - | $ | - | $8,427 | |
| U.S. Treasury securities | - | 2,992 | - | 2,992 | |||
| Total cash equivalents | $8,427 | $2,992 | $ | - | $11,419 | ||
| Current marketable securities: | |||||||
| U.S. Treasury securities | $ | - | $65,242 | $ | - | $65,242 | |
| U.S. Government agency obligations | - | 1,697 | - | 1,697 | |||
| Total current marketable securities | $ | - | $66,939 | $ | - | $66,939 | |
| Total marketable securities and cash equivalents | $8,427 | $69,931 | $ | - | $78,358 | ||
| Financial liabilities: | |||||||
| Long-term debt | $ | - | $ | - | $39,812 | $39,812 | |
| Warrant liability | - | - | 3,158 | 3,158 | |||
| Non-qualified deferred compensation plan liability | - | 3,831 | - | $3,831 | |||
| Total financial liabilities | $ | - | $3,831 | $42,970 | $46,801 | ||
| Financial assets: | |||||||
| Corporate-owned life insurance policies | $ | - | $2,475 | $ | - | $2,475 | |
| Total financial assets | $ | - | $2,475 | $ | - | $2,475 | |
The following table presents the summary of changes in the fair value of our Level 3 financial instruments:
| As of March 31, 2024 · As of December 31, 2023 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Long-term debt · Warrant liability · Long-term debt · Warrant liability | ||||||||
| Balance beginning of period | $39,812 | $3,158 | $ | - | $ | - | ||
| Fair value on issuance date | 37,575 | 2,425 | ||||||
| Change in fair value in earnings | 397 | 870 | 1,616 | 733 | ||||
| Change in fair value in other comprehensive loss | 1,092 | - | 621 | - | ||||
| Balance end of period, at fair value | $41,301 | $4,028 | $39,812 | $3,158 | ||||
The Company’s Level 1 assets include money market instruments and are valued based upon observable market prices. Level 2 assets consist of U.S Treasury securities and U.S. Government Agency obligations. Level 2 securities are valued based upon observable inputs that include reported trades, broker/dealer quotes, bids and offers. The corporate-owned life insurance contracts are recorded at cash surrender value, which approximates the fair value and is categorized as Level 2. Non-qualified deferred compensation plan liability is measured at fair value based on quoted prices of identical instruments to the investment vehicles selected by the participants and its recorded as Level 2. There were no transfers between fair value measurement levels during the period ended March 31, 2024 and December 31, 2023.
Long-term debt
The fair value of the debt was determined using a Monte Carlo Simulation ("MCS") in order to predict the probability of different outcomes. The valuation was performed based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The fair value of the debt is recorded in the Consolidated Balance Sheets. The fair value is estimated by the Company each reporting period and the change in the fair value is recorded in both earnings and other comprehensive income depending on the instrument's inherent credit risk and market risk related to the debt valuation.
As the debt is subject to net revenue requirements, the valuation of the debt was determined using the Monte Carlo Simulation (“MCS”). The underlying metric to be simulated is the projected Trailing Twelve Month (“TTM”) revenues at each quarter end through the maturity date of October 18. 2028. Based on the simulated metric, the different levels of simulated TTM revenues may trigger different discounted cash flow scenarios in which the TTM revenues are lower than the targeted revenues per the Credit Agreement or TTM is equal to or higher than the targeted revenues per the Credit Agreement. The MCS performs 100,000 iterations of various simulated revenues to determine the fair value of the debt.
The below assumptions were used in the Monte Carlo simulation
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Risk-free interest rate | 4.20% | 3.81% |
| Revenue volatility | 64.00% | 64.00% |
| Revenue discount rate | 16.99% | 16.58% |
Warrant Liability
The fair value of the warrant liability is recognized in connection with the Credit Agreement. The fair value of the warrant liability was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The fair value of the warrant liability, which is reported within Warrant liabilities on the Consolidated Balance Sheets, is estimated by the Company based on the Black-Scholes option pricing model with the following key inputs:
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Price of common stock | $16.03 | $13.72 |
| Expected term | 9.56 years | 9.81 years |
| Expected volatility | 31.39% | 31.07% |
| Exercise price | $10.9847 | $10.9847 |
| Risk-free interest rate | 4.16% | 3.84% |
| Expected dividends | 0.00% | 0.00% |
- Revenues
The Company’s revenue consists of sale of the RECELL System to hospitals, treatment centers and distributors. Revenue also includes the sale of PermeaDerm to customers (collectively “commercial customers”). Revenue also includes maintenance fee received from BARDA to ensure first right of access. In the prior year, the Company recorded service revenue for the emergency preparedness services provided to BARDA (collectively "customers"). Services are included in Revenues within the Consolidated Statements of Operations.
Distributor Transactions
For international markets, the Company exclusively partners with third-party distributors (COSMOTEC and PolyMedics Innovation GmbH). Revenue recognition occurs when the distributors obtain control of the product. The terms of sales transactions through distributors are generally consistent with the terms of direct sales to customers and do not contain return rights. These transactions are accounted for in accordance with the Company’s revenue recognition policy described in Note 2 of the Company's Annual Report for the year-ended December 31, 2023.
PermeaDerm Sales
As provided in the Stedical Scientific Distribution Agreement, the Company’s gross margin from the sale of PermeaDerm will be 50% of the average sales price. The Company and Stedical will split the gross revenue from sale of the products evenly through the purchase of products at 50% of Average Sale Price (“ASP”). The Company recognizes revenue when the customer obtains control of promised goods, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods.
Remaining Performance Obligations
Revenues from remaining performance obligations are calculated as the dollar value of the remaining performance obligations on executed contracts and relate to COSMOTEC. The estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied (or partially unsatisfied) pursuant to the Company’s existing customer agreements is $382,000 and $390,000 as of March 31, 2024 and December 31, 2023, respectively. These amounts are split between current and long-term in Other current liabilities and other Contract liabilities, respectively, in the Consolidated Balance Sheets. The Company has $33,000 in Other current liabilities as of March 31, 2024 and December 31, 2023 and $349,000 and $357,000 Contract liabilities as of March 31, 2024 and December 31, 2023, respectively. The Company expects to recognize these amounts as revenue on a straight-line basis over the term of the contract with COSMOTEC.
Contract Assets and Contract Liabilities
Contract assets include amounts related to the Company’s contractual right to consideration for both completed and partially completed performance for which the Company does not have the right to payment. As of March 31, 2024 and December 31, 2023, the Company doesnot have any contract assets.
Contract liabilities are recorded when the Company receives payment prior to satisfying its obligation to transfer goods to a customer. The Company had $382,000 and $390,000 of total contract liabilities as of March 31, 2024 and December 31, 2023, respectively. As of March 31, 2024 and December 31, 2023, a total of $33,000 was included in Other current liabilities and $349,000 and $357,000, respectively, in Contract liabilities in the Consolidated Balance Sheets. The balance relates to the unsatisfied performance obligation from COSMOTEC. The Company recognized approximately $8,000 of revenue from COSMOTEC for amounts included in the beginning balance of contract liabilities for the three-months ended March 31, 2024 and 2023.
Disaggregated Revenue
The Company disaggregates revenue from contracts with customers into geographical regions, by customer type and by product. As noted in the segment footnote, the Company’s business consists of one reporting segment. A reconciliation of disaggregated revenue by geographical region, customer type and product is provided in Note 12.
- Long-term debt
On October 18, 2023 (“Closing Date”) the Company entered into a Credit Agreement, by and between the Company, as borrower, and an affiliate of OrbiMed Advisors, LLC as the lender and administrative agent (the “Lender”). The Credit Agreement provides for afive-year senior secured credit facility in an aggregate principal amount of up to $90.0 million, of which (i) $40.0 million wasmade available on the Closing Date (the “Initial Commitment Amount”), (ii) $25.0 million is available, at the Company’s discretion, on or prior to December 31, 2024, subject to certain net revenue requirements, and (iii) $25.0 million is available, at the Company’s discretion, on or prior to June 30, 2025, subject to certain net revenue requirements. The maturity date of the agreement is October 18, 2028 ("Maturity Date"). On the Closing date, the Company closed on the Initial Commitment Amount of $40.0 million, less certain fees and expenses payable to or on behalf of the Lender. The Company received net proceeds of $38.8 million upon closing after deducting the Lender's transaction costs in connection with the issuance.
All obligations under the Credit Agreement are guaranteed by all of the Company’s wholly owned subsidiaries (subject to certain exceptions) and secured by substantially all of the Company's and each guarantor's assets. The loan will be due in full on the Maturity Date unless the Company elects to repay the principal amount at any time prior to the Maturity Date. Upon prepayment, the Company will owe the applicable repayment premium and exit fee of 3% on the principal amount of the loans. The repayment premium varies between 0.0% -3.0%, depending on certain conditions that are defined in the Credit Agreement. The repayment premium incorporates the make-whole amount. The make-whole amount represents the remaining scheduled interest payments on the loan during the period commencing on the prepayment date through the 24-month anniversary of the closing date. The Credit Agreement further states that the Company will be required to repay the principal amount of the loans if the Company does not achieve certain net revenue thresholds. If, for any quarter until the maturity date, the Company’s net revenue does not equal or exceed the applicable trailing twelve-month amount as set forth in the Credit Agreement, then the Company shall repay in equal quarterly installments equal to 5.0% of the outstanding principal amount on the date the net revenue amount was not satisfied, together with a repayment premium and exit fee. The Company shall repay amounts outstanding in full immediately upon an acceleration as a result of an event of default as set forth in the Credit Agreement, together with a repayment premium and other fees. As of March 31, 2024, the Company hasnot made any repayments on the outstanding debt balance.
During the term of the Credit Agreement, interest payable in cash by the Company shall accrue on any outstanding debt at a rate per annum equal to the greater of (x) the SOFR rate for such period and (y)4.00% plus, in either case,8.00%. As of March 31, 2024, the interest rate was 13.33%. During an event of default, any outstanding amount will bear interest at a rate of 4.00% in excess of the otherwise applicable rate of interest. The Company will pay certain fees with respect to the Credit Agreement, including an upfront fee, an unused fee on the undrawn portion of the Loan Facility, an administration fee, a repayment premium and an exit fee, as well as certain other fees and expenses of the Lender. The undrawn fee accrues at 0.5% of the undrawn balance and its recorded as an asset in the Consolidated Balance Sheets.
The Credit Agreement contains certain customary events of default, including with respect to nonpayment of principal, interest, fees or other amounts; material inaccuracy of a representation or warranty; failure to perform or observe covenants; material defaults on other indebtedness; bankruptcy and insolvency events; material monetary judgments; loss of certain key permits, persons and contracts; material adverse effects; certain regulatory matters; and any change of control. As of March 31, 2024, the Company was in compliance with all financial covenants in the Credit Agreement.
Each of the Credit Agreement and the Pledge and Security Agreement entered into by the Company, the guarantors and the Lender on October 18, 2023 (the “Pledge and Security Agreement”) contains a number of customary representations, warranties and covenants that, among other things, will limit or restrict the ability of the Company and its subsidiaries to (subject to certain qualifications and exceptions): create liens and encumbrances; incur additional indebtedness; merge, dissolve, liquidate or consolidate; make acquisitions, investments, advances or loans; dispose of or transfer assets; pay dividends or make other payments in respect of their capital stock; amend certain material documents; redeem or repurchase certain debt; engage in certain transactions with affiliates; and enter into certain restrictive agreements. In addition, the Company and guarantors will be required to maintain at least $10.0 million of unrestricted cash and cash equivalents.
On the Closing Date, the Company issued to an affiliate of the Lender a warrant (the “Warrant”) to purchase up to 409,661 shares of the Company’s Common Stock, par value $0.0001 per share (“Common Stock”), at an exercise price of $10.9847 per share, with a term of 10 years from the issuance date. The Warrant contains customary share adjustment provisions, as well as weighted average price protection in certain circumstances.
As permitted under ASC 825, Financial Instruments, the Company elected the fair value option to record the long-term debt and warrant with changes in fair value recorded in the Consolidated Statements of Operations in Other income (expense), net. Changes related to instrument specific credit risk are revalued bycomparing the amount of the total change in fair value of the long-term debt to the amount of change in fair value that would have occurred if the Company’s credit spread had not changed between the reporting periods, and is recorded in other comprehensive income in the Consolidated Balance Sheet. The difference between the fair value of the long-term debt and the unpaid principal balance of $40.0 million is an additional liability of $1.3 million and reduction to the liability of $188,000 as of March 31, 2024 and December 31, 2023, respectively. For changes in fair value refer to Note 4.
- Leases
During January 2024, the Company modified the lease agreement of the Ventura production facility to extend the lease term. The modification resulted in an increase of approximately $1.3 million to the operating lease ROU assets and operating lease liabilities. There was no impact on earnings as a result of the lease modification.
The following table sets forth the Company’s operating lease expenses which are included in operating expenses in the Consolidated Statements of Operations (in thousands):
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Operating lease cost | $296 | $198 |
| Variable lease cost | 35 | 13 |
| Total lease cost | $331 | $211 |
Supplemental cash flow information related to operating leases for the three-months ended March 31, 2024 and 2023 (in thousands):
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash outflows from operating leases | $293 | $205 |
Supplemental balance sheet information, as of March 31, 2024 and December 31, 2023, related to operating leases was as follows (in thousands, except for operating lease weighted average remaining lease term and operating lease weighted average discount rate):
| As of | ||
|---|---|---|
| March 31, 2024 | December 31, 2023 | |
| Reported as: | ||
| Operating lease right-of-use assets | $3,275 | $2,440 |
| Total right-of-use assets | $3,275 | $2,440 |
| Other current liabilities: | ||
| Operating lease liabilities, short-term | $903 | $895 |
| Operating lease liabilities, long term | 2,532 | 1,702 |
| Total operating lease liabilities | $3,435 | $2,597 |
| Operating lease weighted average remaining lease term (years) | 3.46 | 3.31 |
| Operating lease weighted average discount rate | 9.42% | 8.75% |
As of March 31, 2024, maturities of the Company’s operating lease liabilities are as follows (in thousands):
| Operating Leases | |
|---|---|
| Remainder of 2024 | $891 |
| 2025 | 1,165 |
| 2026 | 1,125 |
| 2027 | 657 |
| 2028 | 190 |
| Total lease payments | 4,028 |
| Less imputed interest | (593) |
| Total operating lease liabilities | $3,435 |
As of March 31, 2024, there were no leases entered into that had not yet commenced.
- Inventory
The composition of inventory is as follows (in thousands):
| As of | ||
|---|---|---|
| March 31, 2024 | December 31, 2023 | |
| Raw materials | $2,693 | $3,683 |
| Work in process | 446 | 878 |
| Finished goods | 4,032 | 1,035 |
| Total inventory | $7,171 | $5,596 |
The Company values its inventories to reflect the lower of cost or net realizable value. Charges for estimated excess and obsolescence are recorded in cost of sales in the Consolidated Statements of Operations and were$83,000 and $67,000 for the three-months ended March 31, 2024 and 2023, respectively. The inventory balance as of March 31, 2024, includes inventory purchased from Stedical for the sales of PermeaDerm.
- Intangible Assets
The composition of intangible assets, net is as follows (in thousands):
| As of March 31, 2024 · As of December 31, 2023 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| WeightedAverage Useful Life · GrossAmount · AccumulatedAmortization · NetCarryAmount · GrossAmount · AccumulatedAmortization · NetCarryAmount | ||||||||||||||
| Patent 1 | 3 | $17 | $(17) | $ | - | $17 | $(17) | $ | - | |||||
| Patent 2 | 13 | 141 | (42) | 99 | 141 | (39) | 102 | |||||||
| Patent 3 | 14 | 206 | (58) | 148 | 206 | (54) | 152 | |||||||
| Patent 5 | 19 | 104 | (13) | 91 | 99 | (11) | 88 | |||||||
| Patent 6 | 19 | 56 | (7) | 49 | 56 | (6) | 50 | |||||||
| Patent 7 | 13 | 2 | - | 2 | 2 | - | 2 | |||||||
| Patent 8 | 18 | 31 | (2) | 29 | 29 | (1) | 28 | |||||||
| Patent 9 | 3 | 68 | (6) | 62 | 3 | - | 3 | |||||||
| Patent 10 | 19 | 3 | - | 3 | 3 | - | 3 | |||||||
| Patent 11 | 19 | 6 | (1) | 5 | 6 | (1) | 5 | |||||||
| Trademarks | Indefinite | 54 | - | 54 | 54 | - | 54 | |||||||
| Total intangible assets | $688 | $(146) | $542 | $616 | $(129) | $487 | ||||||||
During the three-months ended March 31, 2024 and 2023, the Company did not identify any events or changes in circumstances that indicated that the carrying value of its intangibles may not be recoverable. As such, there wasno impairment of intangibles assets recognized for the three-months ended March 31, 2024 and 2023 Amortization expense of intangibles included in the Consolidated Statements of Operations was $17,000 and $9,000 for the three months ended March 31, 2024 and 2023, respectively.
The Company expects the future amortization of amortizable intangible assets held at March 31, 2024 to be as follows (in thousands):
| Estimated Amortization Expense | |
|---|---|
| Remainder of 2024 | $48 |
| 2025 | 64 |
| 2026 | 51 |
| 2027 | 37 |
| 2028 | 37 |
| Thereafter | 251 |
| Total | $488 |
- Plant and Equipment
The composition of plant and equipment, net is as follows (in thousands):
| As of | |||
|---|---|---|---|
| Useful Lives | March 31, 2024 | December 31, 2023 | |
| Computer equipment | 3 - 5 years | $1,157 | $984 |
| Computer software | 3 years | 840 | 840 |
| Construction in progress | 2,292 | 87 | |
| Furniture and fixtures | 7 years | 847 | 824 |
| Laboratory and other equipment | 3 - 5 years | 965 | 769 |
| Leasehold improvements | Lesser of life or lease term | 367 | 367 |
| RECELL moulds | 5 years | 447 | 438 |
| Less: accumulated amortization and depreciation | (2,618) | (2,432) | |
| Total plant and equipment, net | $4,297 | $1,877 | |
Construction in progress consists primarily of leasehold improvements for the renovations to the Ventura production facility and materials for the manufacture of the RECELL GO devices.
Depreciation expense related to plant and equipment was $186,000 and $126,000 for the three-months ended March 31, 2024 and 2023 respectively. During the three-months ended March 31, 2024 and 2023, the Company did not identify any events or changes in circumstances that indicated that the carrying value of its plant and equipment may not be recoverable. As such, there wasno impairment of plant and equipment recognized for the three-months ended March 31, 2024 and 2023.
- Other Current and Long-Term Assets and Liabilities
Prepaids and other current assets consisted of the following (in thousands):
| As of | ||
|---|---|---|
| March 31, 2024 | December 31, 2023 | |
| Prepaid expenses | $1,216 | $1,376 |
| Unsettled investment receivable | 1,000 | - |
| Amounts due from Stedical | 941 | - |
| Accrued investment income | 182 | 227 |
| Lease deposits | 49 | 38 |
| Other receivables | 135 | 18 |
| Total prepaids and other current assets | $3,523 | $1,659 |
Prepaid expenses primarily consist of prepaid benefits and insurance.
Other long-term assets consisted of the following (in thousands):
| As of | ||
|---|---|---|
| March 31, 2024 | December 31, 2023 | |
| Long-term lease deposits | $151 | $155 |
| Long-term prepaids | 135 | 148 |
| Other long-term assets | 115 | 52 |
| Total other long-term assets | $401 | $355 |
Other current liabilities consisted of the following (in thousands):
| As of | ||
|---|---|---|
| March 31, 2024 | December 31, 2023 | |
| Operating lease liability | $903 | $895 |
| COSMOTEC deferred revenue | 33 | 33 |
| Other current liabilities | 217 | 338 |
| Total other current liabilities | $1,153 | $1,266 |
- Reporting Segment and Geographic Information
The Company views its operations and manages its business inone reporting segment. Long-lived assets are primarily located in the United States as of March 31, 2024, and December 31, 2023.
Revenue by region for the three-months March 31, 2024 and 2023 were as follows (in thousands):
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Revenue by region: | ||
| United States | $10,532 | $9,425 |
| Japan | 461 | 1,021 |
| European Union | 51 | - |
| Australia | 17 | 62 |
| United Kingdom | 43 | 42 |
| Total | $11,104 | $10,550 |
Revenue by customer type for the three-months ended March 31, 2024 and 2023 were as follows (in thousands):
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Revenue by customer type: | ||
| Commercial sales | $11,068 | $10,458 |
| Deferred commercial revenue recognized | 8 | - |
| BARDA services for emergency preparedness | - | 92 |
| BARDA revenue for right of first access | 28 | - |
| Total | $11,104 | $10,550 |
Commercial revenue by product for the three-months ended March 31, 2024 and 2023 were as follows (in thousands):
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Commercial revenue by product: | ||
| RECELL | 10,962 | 10,458 |
| Other wound care products | 106 | - |
| Total commercial sales | $11,068 | $10,458 |
Cost of sales by customer type for the three-months ended March 31, 2024 and 2023 were as follows (in thousands):
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Cost of sales: | ||
| Commercial cost | $1,513 | $1,616 |
| BARDA: | ||
| Product cost | - | (34) |
| Emergency preparedness service cost | - | 85 |
| Total | $1,513 | $1,667 |
- Commitments and Contingencies
The Company is subject to certain contingencies arising in the ordinary course of business. The Company records accruals for these contingencies to the extent that a loss is both probable and reasonably estimable. If some amount within a range of loss appears more likely than any other amount within the range, that amount is accrued. Alternatively, when no amount within a range of loss appears to be a better estimate than any other amount, the lowest amount in the range is accrued. The Company expenses legal costs associated with loss contingencies as incurred. As of March 31, 2024 and December 31, 2023, the Company didnot have any outstanding or threatened litigation that would have a material impact on the financial statements.
Minimum Purchase Commitments with Stedical
The Company is subject to minimum purchase of PermeaDerm product for the initial term offive years. For 2024, the Company has an obligation to purchase a minimum of $5.0 million of inventory from Stedical. As of March 31, 2024, the Company has purchased $2.6 million in inventory with another $2.4 million remaining. This obligation isnot recorded in the Company's Consolidated Balance Sheets. For the first three years of the agreement, the minimum purchase should increase annually by an amount equal to the percentage growth in the Company's annual US based revenues excluding PermeaDerm revenue, or a minimum increase of at least 20% over the prior year purchase commitment. For years after the third year, the minimum purchase obligation shall increase annually by an amount equal to the percentage growth of the Company's annual US-based revenues excluding PermeaDerm sales. The minimum purchase obligation should never decrease from the previous year.
- Common and Preferred Stock
The Company’s CHESS Depositary Interests (“CDIs”) are quoted on the ASX under the ticker code, “AVH.” The Company’s shares of Common Stock are quoted on the Nasdaq Capital Market (“Nasdaq”) under the ticker code, “RCEL”. One share of Common Stock on Nasdaq is equivalent to five CDIs on the ASX.
The Company is authorized to issue 200,000,000 shares of Common Stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share, issuable in one or more series as designated by the Company’s board of directors. No other class of capital stock is authorized. As of March 31, 2024, and December 31, 2023,25,789,051 and 25,682,078 shares of Common Stock, respectively, were issued and outstanding andno shares of preferred stock were outstanding during any period.
- Stock-Based Payment Plans
Stock-Based Payment Expenses
Stock-based payment transactions are recognized as compensation expense based on the fair value of the instrument on the date of grant. The Company uses the graded-vesting method to recognize compensation expense. Compensation cost is reduced for forfeitures as they occur in accordance with ASU 2016-09, Simplifying the Accounting for Share-Based Payment. The Company recorded stock-based compensation and Employee Stock Purchase Plan ("ESPP") expense of $2.6 million for the three-months ended March 31, 2024 and 2023, respectively. No income tax benefit was recognized in the Consolidated Statements of Operations for stock-based payment arrangements for the three-months ended March 31, 2024 and 2023.
The Company has included stock-based compensation expense for all equity awards and the ESPP as part of operating expenses in the accompanying Consolidated Statements of Operations as follows:
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Sales and marketing expenses | $527 | $325 |
| General and administrative expenses | 1,661 | 2,090 |
| Research and development expenses | 403 | 225 |
| Total | $2,591 | $2,640 |
A summary of share option activity as of March 31, 2024, and changes during the period ended is presented below:
| Service Only Share Options | Performance Based Share Options | Total Share Options | |
|---|---|---|---|
| Outstanding shares at December 31, 2023 | 2,397,571 | 292,587 | 2,690,158 |
| Granted | 1,156,000 | - | 1,156,000 |
| Exercised | (86,244) | (20,729) | (106,973) |
| Expired | (25,786) | (39,174) | (64,960) |
| Forfeited | (128,185) | (4,656) | (132,841) |
| Outstanding shares at March 31, 2024 | 3,313,356 | 228,028 | 3,541,384 |
| Exercisable at March 31, 2024 | 839,751 | 190,532 | 1,030,283 |
| Vested and expected to vest - March 31, 2024 | 3,313,356 | 228,028 | 3,541,384 |
A summary of the status of the Company’s unvested RSUs as of March 31, 2024, and changes that occurred during the period is presented below:
| Unvested Shares | Tenure-Based RSUs | PerformanceCondition RSUs | Total RSUs |
|---|---|---|---|
| Unvested RSUs outstanding at December 31, 2023 | 207,112 | 28,020 | 235,132 |
| Granted | - | - | - |
| Vested | - | - | - |
| Forfeited | (17,400) | (3,504) | (20,904) |
| Unvested RSUs outstanding at March 31, 2024 | 189,712 | 24,516 | 214,228 |
Employee Stock Purchase Plan
In June 2023, the stockholders approved the ESPP, which became effective on July 1, 2023. On June 30, 2023, the Company filed Registration Statement on Form S-8 to register 1,000,000 shares of Common Stock under the ESPP, as a result of the Company’s stockholders approving the ESPP at the 2023 Annual Meeting. The ESPP features two six-month offering periods per year, running from June 1 to November 30 and December 1 to May 31.
During the three-months ended March 31, 2024, the Company recorded $186,000 in ESPP expense. During the three-months ended March 31, 2023, the Company didnot have any ESPP expense. The Company had $583,000 and $122,000 in accrued payroll contributions as of March 31, 2024 and December 31, 2023, respectively. As of March 31, 2024, the Company had 927,681 shares remaining to be issued under the plan.
- Income Taxes
Tax expense for the three-months ended March 31, 2024 and 2023 was $30,000. These amounts are related to state minimum taxes.
- Net Loss per Share
The following is a reconciliation of the basic and diluted loss per share computations:
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| (in thousands, except per share amounts) | ||
| Net loss | $(18,658) | $(9,220) |
| Weighted-average common shares—outstanding, basic and diluted | 25,638 | 25,202 |
| Net loss per common share, basic and diluted | $(0.73) | $(0.37) |
| Three-Months Ended | ||
|---|---|---|
| March 31, 2024 | March 31, 2023 | |
| Anti-dilutive shares excluded from diluted net loss per common share: | ||
| Stock options | 3,541,384 | 2,218,496 |
| Restricted stock units | 214,228 | 371,368 |
| ESPP | 83,545 | - |
| Warrants | 409,661 | - |
The Company’s basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the relevant period. In accordance with ASC 710-10, Compensation - General,83,893 shares of Common Stock held by the rabbi trust are excluded from the denominator in the basic and diluted net loss per common share calculations. For details on shares of common stock held by the rabbi trust refer to Note 18. For the purposes of the calculation of diluted net loss per share, options to purchase common stock, restricted stock units and unvested shares of common stock issued upon the early exercise of stock options have been excluded from the calculation of diluted net loss per share as their effect is anti-dilutive. Because the Company has reported a net loss for the three-months ended March 31, 2024 and 2023, diluted net loss per common share is the same as the basic net loss per share for those periods.
- Retirement Plans
The Company offers a 401(k) retirement savings plan (the “401(k) Plan”) for its employees, including its executive officers, who satisfy certain eligibility requirements. The Internal Revenue Code of 1986, as amended, allows eligible employees to defer a portion of their compensation, within prescribed limits, on a pre-tax basis through contributions to the 401(k) Plan. The Company matches contributions to the 401(k) Plan based on the amount of salary deferral contributions the participant makes to the 401(k) Plan. The Company will match up to 6% of an employee’s compensation that the employee contributes to his or her 401(k) Plan account up to the maximum allowable. Total Company's matching contributions to the 401(k) Plan were $835,000 and $423,000 for the three-months ended March 31, 2024 and 2023, respectively.
Non-Qualified Deferred Compensation Plan
The Company’s NQDC plan, which became effective in October 2021 allows for eligible management and highly compensated key employees to elect to defer a portion of their salary, bonus, commissions and RSU awards to later years. Cash deferrals are immediately vested and are subject to investment risk and a risk of forfeiture under certain circumstances. RSU deferrals are subject to the vesting conditions of the award. Once RSUs vest, subject to a six-month and one day holding period, employees are allowed to diversify the common stock into other investment options offered by the plan. For cash deferrals, the Company matches 4% to 6% (depending on level) of employee contributions. These matching employer contributions are vested over atwo-year period with 25% vesting on year one and 75% vesting on year two for employees under 55 years of age. Employer contributions for employees over 55 years of age are immediately vested. Employer contributions to the NQDC Plan were $34,000 and $42,000 for the three-months ended March 31, 2024 and 2023, respectively. The Company’s deferred compensation plan liability was $4.3 million and $3.8 million as of March 31, 2024 and December 31, 2023, respectively. These liabilities are split between current and long term on the Consolidated Balance Sheets. As of March 31, 2024, $429,000 is included in Current non-qualified deferred compensation liability and $3.9 million in the long term non-qualified deferred compensation liability. As of December 31, 2023,$168,000 is included in Current non-qualified deferred compensation liability and $3.7 million in the long-term non-qualified deferred compensation liability. During the three-months ended March 31, 2024, the Company had distributions of approximately $215,000 in the deferred compensation liability for terminated employees. During the three-months ended March 31, 2023, the Company didnot have any distributions.
The Company established a COLI to fund the NQDC Plan. Amounts in the COLI are invested in a number of funds. The securities are carried at the cash surrender value on the Consolidated Balance Sheets. We record investment gains and losses of the
COLI as Other income (expense), net. Refer to Note 4, Fair Value Measurements for the fair values of the COLI policies and the NQDC liability.
Rabbi Trust
During April 2022, the Company established a rabbi trust to hold the assets of the NQDC Plan. The rabbi trust holds the COLI asset and the Common Stock from deferred RSU awards that have vested. The NQDC Plan permits diversification of fully vested shares into other equity securities subject to a six-month and one day holding period. In accordance with ASR 268, Redeemable Preferred Stock, and ASC 718, Compensation — Stock Compensation, prior to vesting, the deferred share awards are classified as an equity instrument and changes in fair value of the amount owed to the participant are not recognized. The redemption amounts of the deferred awards are based on the vested percentage and are recorded outside of permanent equity as Non-qualified deferred compensation share awards on the Consolidated Balance Sheets. As of March 31, 2024 and December 31, 2023, a total of 117,326 and 81,052, shares awards have been deferred, respectively. Vested shares are converted to Common Stock and are reclassified to permanent equity. Common Stock held in the rabbi trust is classified in a manner similar to treasury stock and presented separately on the Consolidated Balance Sheets as Common Stock held by the NQDC Plan. As of March 31, 2024 and December 31, 2023 a total of 83,893 and 99,106 shares were held in the rabbi trust at the redemption value of $944,000 and $1.1 million, respectively.
The following table summarizes the Non-qualified deferred compensation plan share award activity as of March 31, 2024 and December 31, 2023 (in thousands):
| As of | ||
|---|---|---|
| (in thousands) | March 31, 2024 | December 31, 2023 |
| Non-qualified deferred compensation share awards: | ||
| Balance at beginning of period | $693 | $557 |
| Stock-based compensation expense | 6 | 518 |
| Change in redemption value | 128 | 1,019 |
| Vesting of share awards held by NDQC | - | (1,401) |
| Ending Balance | $827 | $693 |
- Subsequent Events
The Company has evaluated subsequent events through the filing of this Quarterly Report on Form 10-Q and determined that no events that have occurred that would require adjustment to or disclosures in the Consolidated Financial Statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.