Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 07, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Registrant Name | AVITA MEDICAL, INC. | |
Entity Central Index Key | 0001762303 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Security Exchange Name | NASDAQ | |
Trading Symbol | RCEL | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Entity Interactive Data Current | Yes | |
Entity Address, State or Province | CA | |
Entity Incorporation, State or Country Code | DE | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 25,030,902 | |
Entity File Number | 001-39059 | |
Entity Tax Identification Number | 85-1021707 | |
Entity Address, Address Line One | 28159 Avenue Stanford | |
Entity Address, Address Line Two | Suite 220 | |
Entity Address, City or Town | Valencia | |
Entity Address, Postal Zip Code | 91355 | |
City Area Code | (661) | |
Local Phone Number | 367-9170 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
ASSETS | ||
Cash and cash equivalents | $ 23,613,000 | $ 55,511,000 |
Marketable securities | 60,559,000 | 29,649,000 |
Accounts receivable, net | 3,553,000 | 3,118,000 |
BARDA receivables | 792,000 | 308,000 |
Prepaids and other current assets | 1,041,000 | 1,213,000 |
Restricted cash | 202,000 | 201,000 |
Inventory | 1,960,000 | 2,132,000 |
Total current assets | 91,720,000 | 92,132,000 |
Marketable securities, long-term | 4,012,000 | 19,692,000 |
Plant and equipment, net | 1,226,000 | 1,262,000 |
Operating lease right-of-use assets | 1,029,000 | 1,544,000 |
Corporate-owned life insurance asset | 948,000 | 304,000 |
Intangible assets, net | 449,000 | 443,000 |
Other long-term assets | 548,000 | 638,000 |
Total assets | 99,932,000 | 116,015,000 |
LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Accounts payable and accrued liabilities | 3,118,000 | 2,708,000 |
Accrued wages and fringe benefits | 4,776,000 | 5,363,000 |
Other current liabilities | 1,619,000 | 1,075,000 |
Total current liabilities | 9,513,000 | 9,146,000 |
Non-qualified deferred compensation plan liability | 1,016,000 | 262,000 |
Contract liabilities | 740,000 | 952,000 |
Operating lease liabilities, long-term | 405,000 | 918,000 |
Other long-term liabilities | 113,000 | |
Total liabilities | 11,674,000 | 11,391,000 |
Non-qualified deferred compensation plan share awards | 272,000 | |
Contingencies (Note 12) | ||
Shareholders' Equity: | ||
Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,030,902 and 24,925,743 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 3,000 | 3,000 |
Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2022 and December 31, 2021 | ||
Company common stock held by the non-qualified deferred compensation plan | (127,000) | |
Additional paid-in capital | 337,995,000 | 332,484,000 |
Accumulated other comprehensive income | 7,350,000 | 8,060,000 |
Accumulated deficit | (257,235,000) | (235,923,000) |
Total shareholders' equity | 87,986,000 | 104,624,000 |
Total liabilities and shareholders' equity | $ 99,932,000 | $ 116,015,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement Of Financial Position [Abstract] | ||
Common stock par value | $ 0.0001 | $ 0.0001 |
Common stock shares authorized | 200,000,000 | 200,000,000 |
Common stock shares issued | 25,030,902 | 24,925,743 |
Common stock shares outstanding | 25,030,902 | 24,925,743 |
Preferred stock par value | $ 0.0001 | $ 0.0001 |
Preferred stock shares authorized | 10,000,000 | 10,000,000 |
Preferred stock shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenues | $ 9,092 | $ 7,020 | $ 24,966 | $ 26,089 |
Cost of sales | (1,530) | (1,088) | (4,694) | (5,287) |
Gross profit | 7,562 | 5,932 | 20,272 | 20,802 |
BARDA income | 904 | 374 | 2,189 | 1,384 |
Operating expenses: | ||||
Sales and marketing expenses | (5,411) | (3,518) | (15,571) | (11,313) |
General and administrative expenses | (5,004) | (5,349) | (18,009) | (16,046) |
Research and development expenses | (3,799) | (3,388) | (10,478) | (11,471) |
Total operating expenses | (14,214) | (12,255) | (44,058) | (38,830) |
Operating loss | (5,748) | (5,949) | (21,597) | (16,644) |
Interest expense | (6) | (9) | (10) | (21) |
Other income | 170 | 16 | 307 | 25 |
Loss before income taxes | (5,584) | (5,942) | (21,300) | (16,640) |
Income tax expense | (4) | (6) | (12) | (23) |
Net loss | $ (5,588) | $ (5,948) | $ (21,312) | $ (16,663) |
Net loss per common share: | ||||
Basic | $ (0.22) | $ (0.24) | $ (0.85) | $ (0.69) |
Diluted | $ (0.22) | $ (0.24) | $ (0.85) | $ (0.69) |
Weighted-average common shares: | ||||
Basic | 25,006,995 | 24,905,403 | 24,972,331 | 24,174,811 |
Diluted | 25,006,995 | 24,905,403 | 24,972,331 | 24,174,811 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (5,588) | $ (5,948) | $ (21,312) | $ (16,663) |
Other comprehensive income gain/(loss): | ||||
Change in foreign currency translation loss | (96) | (50) | (188) | (80) |
Change in net unrealized loss on marketable securities, net of tax | (90) | (10) | (522) | (10) |
Comprehensive loss | $ (5,774) | $ (6,008) | $ (22,022) | $ (16,753) |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Company Common Stock Held by the NQDC | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2020 | $ 59,597 | $ 3 | $ 262,086 | $ 8,289 | $ (210,781) | |
Beginning balance, shares at Dec. 31, 2020 | 21,625,058 | |||||
Net loss | (16,663) | (16,663) | ||||
Issuance of common stock under direct placement | 69,106 | 69,106 | ||||
Issuance of common stock under direct placement, shares | 3,214,250 | |||||
Issuance costs associated with direct placement | (5,109) | (5,109) | ||||
Share-based compensation | 4,585 | 4,585 | ||||
Exercise of stock options | 66 | 66 | ||||
Exercise of stock options, shares | 9,550 | |||||
Vesting of restricted stock units, shares | 76,260 | |||||
Other comprehensive loss | (90) | (90) | ||||
Ending Balance at Sep. 30, 2021 | 111,492 | $ 3 | 330,734 | 8,199 | (227,444) | |
Ending Balance, shares at Sep. 30, 2021 | 24,925,118 | |||||
Beginning Balance at Jun. 30, 2021 | 115,655 | $ 3 | 328,889 | 8,259 | (221,496) | |
Beginning balance, shares at Jun. 30, 2021 | 24,895,864 | |||||
Net loss | (5,948) | (5,948) | ||||
Share-based compensation | 1,842 | 1,842 | ||||
Exercise of stock options | 3 | 3 | ||||
Exercise of stock options, shares | 500 | |||||
Vesting of restricted stock units, shares | 28,754 | |||||
Other comprehensive loss | (60) | (60) | ||||
Ending Balance at Sep. 30, 2021 | 111,492 | $ 3 | 330,734 | 8,199 | (227,444) | |
Ending Balance, shares at Sep. 30, 2021 | 24,925,118 | |||||
Beginning Balance at Dec. 31, 2021 | 104,624 | $ 3 | 332,484 | 8,060 | (235,923) | |
Beginning balance, shares at Dec. 31, 2021 | 24,925,743 | |||||
Net loss | (21,312) | (21,312) | ||||
Share-based compensation | 5,495 | 5,495 | ||||
Exercise of stock options | $ 1 | 1 | ||||
Exercise of stock options, shares | 125 | 125 | ||||
Vesting of restricted stock units, shares | 87,107 | |||||
Company common stock held by the NQDC | $ (127) | 127 | ||||
Company common stock held by the NQDC, Shares | 17,927 | |||||
Change in classification of deferred compensation share awards | $ (192) | (192) | ||||
Change in redemption value of share awards in NQDC plan | 80 | 80 | ||||
Other comprehensive loss | (710) | (710) | ||||
Ending Balance at Sep. 30, 2022 | 87,986 | $ 3 | (127) | 337,995 | 7,350 | (257,235) |
Ending Balance, shares at Sep. 30, 2022 | 25,030,902 | |||||
Beginning Balance at Jun. 30, 2022 | 92,560 | $ 3 | 336,668 | 7,536 | (251,647) | |
Beginning balance, shares at Jun. 30, 2022 | 25,003,088 | |||||
Net loss | (5,588) | (5,588) | ||||
Share-based compensation | 1,229 | 1,229 | ||||
Vesting of restricted stock units, shares | 9,887 | |||||
Company common stock held by the NQDC | (127) | 127 | ||||
Company common stock held by the NQDC, Shares | 17,927 | |||||
Change in redemption value of share awards in NQDC plan | (29) | (29) | ||||
Other comprehensive loss | (186) | (186) | ||||
Ending Balance at Sep. 30, 2022 | $ 87,986 | $ 3 | $ (127) | $ 337,995 | $ 7,350 | $ (257,235) |
Ending Balance, shares at Sep. 30, 2022 | 25,030,902 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flow from operating activities: | ||
Net loss | $ (21,312) | $ (16,663) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 438 | 517 |
Share-based compensation | 5,782 | 4,585 |
Non-cash lease expense | 515 | 477 |
Loss on fixed asset disposal | 3 | 130 |
Patent impairment loss | 19 | |
Remeasurement and foreign currency transaction gain | (121) | (28) |
Excess and obsolete inventory related charges | 284 | 288 |
BARDA deferred costs | (12) | 343 |
Contract cost amortization | 253 | 211 |
Provision for doubtful accounts | 10 | 21 |
Amortization of premium of marketable securities | (12) | 36 |
Non-cash changes in the fair value of NQDC plan | (5) | |
Changes in operating assets and liabilities: | ||
Trade and other receivables | (449) | (1,197) |
BARDA receivables | (484) | (163) |
Prepaids and other current assets | 168 | (316) |
Inventory | (119) | 107 |
Operating lease liability | (531) | (492) |
Corporate-owned life insurance asset | (840) | |
Other long-term assets | (163) | (763) |
Accounts payable and accrued expenses | 433 | (336) |
Accrued wages and fringe benefits | (570) | (635) |
Other current liabilities | 511 | 70 |
Non-qualified deferred compensation plan liability | 829 | |
Contract liabilities | (212) | 422 |
Other long-term liabilities | (50) | 238 |
Net cash used in operations | (15,654) | (13,129) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (59,408) | (49,550) |
Maturities of marketable securities | 43,669 | |
Cash paid for property and equipment | (382) | (490) |
Cash paid for patent filing fees | (53) | (142) |
Net cash used in investing activities | (16,174) | (50,182) |
Cash flow from financing activities: | ||
Proceeds from direct placement of common stock | 69,106 | |
Issuance cost associated with direct placement | (5,109) | |
Principal repayment of finance lease | (2) | |
Proceeds from exercise of stock options | 1 | 66 |
Net cash provided by financing activities | 1 | 64,061 |
Effect of foreign exchange rate on cash and restricted cash | (70) | (31) |
Net increase/(decrease) in cash and cash equivalents and restricted cash | (31,897) | 719 |
Cash and cash equivalents and restricted cash beginning of the period | 55,712 | 59,966 |
Cash and cash equivalents and restricted cash end of the period | 23,815 | 60,685 |
Supplemental Disclosure of Cash Flow Information | ||
Cash paid for income taxes | 17 | 28 |
Cash paid for interest | 10 | $ 20 |
Plant and equipment purchases not yet paid | $ 7 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2022 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
The Company | 1. The Company Nature of the Business The AVITA group of companies (comprising AVITA Medical, Inc. (“ AVITA Company AVITA Medical FDA PMA Following receipt of our original In February 2022, the FDA approved a PMA supplement for the RECELL Autologous Cell Harvesting Device , an enhanced ease-of-use device aimed at providing clinicians a more efficient user experience and simplified workflow. IDEs In February 2019, we entered into a collaboration with COSMOTEC, an M3 Group company, to market and distribute the RECELL System in Japan. We worked with COSMOTEC to advance our application for approval of the RECELL System in Japan pursuant to Japan’s Pharmaceuticals and Medical Devices Act (“ PMDA In March 2020, the World Health Organization declared the outbreak of a novel strain of the coronavirus (“ COVID-19 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. 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 SEC ASX Transition Report There have been no changes to the Company’s significant accounting policies as described in the T ransition R eport on Form 10-K T 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 Transition 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. Reclassification of Prior Year Presentation Certain prior year amounts within other long-term assets and other long-term liabilities have been reclassified to Corporate-owned life insurance asset and Non-qualified deferred compensation plan liability, respectively, in the Consolidated Balance Sheets, for consistency with current period presentation. These reclassifications had no effect on the reported results of operations or financial position. Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts (including doubtful accounts, carrying value of long-lived assets, the useful lives of long-lived assets, accounting for marketable securities, income taxes, share-based compensation, and the stand-alone selling price for the BARDA contract) 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 accumulated other comprehensive gain (loss) in shareholders’ equity. Gains and losses resulting from foreign currency transactions are included in general and administrative expenses and were a gain of $76,000 and $41,000 for the three-months ended September 30, 2022 and 2021, respectively. Foreign currency transactions were a gain of $123,000 and $58,000 for the nine-months ended September 30, 2022 and 2021, respectively. 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 and foreign currency transactions are included in general and administrative expenses. During the three-months ended September 30, 2022 and 2021, the Company recorded gains of $6,000 and a loss of $14,000, respectively. The Company recorded losses of $2,000 and $30,000 for the nine-months ended September 30, 2022 and 2021, respectively. Comprehensive Loss The components of comprehensive loss consist of net loss, foreign currency translation adjustments from its subsidiaries not using the U.S. dollar as their functional currency and unrealized gains and losses in investments available for sale. The Company did not have reclassifications from other comprehensive loss to net loss during the three and nine-months ended September 30, 2022. Revenue Recognition The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Accounting Standard Codification (“ASC”) Topic 606, Revenue Recognition, the Company performs the following five steps: 1. Identify the contract with a customer 2. Identify the performance obligations 3. Determine the transaction price 4. Allocate the transaction price to the performance obligations 5. Recognize revenue when/as performance obligation(s) are satisfied In order for an arrangement to be considered a contract, it must be probable that the Company will collect the consideration to which it is entitled for goods or services to be transferred. Once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised with each contract, determines whether those are performance obligations and the related transaction price. The Company then recognizes the sale of goods based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. The Company’s revenue consists primarily of the sale of the RECELL System to hospitals or other treatment centers and to BARDA (collectively, “customers”), predominately in the United States. The Company evaluated the BARDA contract and concluded that a portion of the arrangement, such as the procurement of the RECELL system and the emergency preparedness, represents a transaction with a customer and as such are in the scope of ASC 606. Amounts received from BARDA for the research and development of the Company’s product are classified as BARDA income in the Consolidated Statements of Operations and are accounted for under IAS 20. For further details refer to BARDA Income and Receivables below. Revenues for commercial customers (hospitals and treatment centers) are recognized as control of the product is transferred to customers, at an amount that reflects the consideration expected to be received in exchange for the product. Revenues are recognized net of volume discounts. As such, revenue is recognized only to the extent a significant reversal of revenues is not expected to occur in subsequent periods. For the Company’s contracts that have an original duration of one year or less, the Company elected the practical expedient applicable to such contracts and does not consider the time value of money. Further, because of the short duration of these contracts, the Company has not disclosed the transaction price for the remaining performance obligations as of each reporting period or when the Company expects to recognize this revenue. The Company has further applied the practical expedient to exclude sales tax in the transaction price and expense contract fulfilment costs such as commissions and shipping and handling expenses as incurred. For revenues related to the BARDA contract within the scope of ASC 606, the Company identified two performance obligations: (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. Through this contract the Company promises to procure the product through a vendor management inventory arrangement and to stand ready to provide emergency deployment services related to the product. Emergency preparedness services include procuring necessary storage containers, housing, and maintaining the containers (and product), and providing shipping and handling services in the event of an emergency situation. This stand ready obligation is a series of distinct services that are substantially the same and have the same pattern of transfer to the customer, overtime as services are consumed. The total transaction price for the portion of the BARDA contract that is within the scope of ASC 606, was determined to be $9.2 million. The transaction price was allocated on a stand-alone selling price basis as follows: $7.6 million to the procurement of the RECELL product, which is classified as Revenues when recognized in the Consolidated Statements of Operations and $1.6 million to the emergency deployment services which is classified as Revenues when recognized in the Consolidated Statements of Operations. The $1.6 million for emergency deployment includes variable consideration which is deemed immaterial to the contract as a whole. The Company estimated the stand-alone selling price of the procurement of the RECELL product based on historical pricing of the Company’s product at the initial execution of the contract. The Company estimated the stand-alone selling price of the emergency deployment services performed based on the Company’s projected cost of providing the services plus an applicable profit margin as denoted in the contract. The Company’s performance obligations are either satisfied at a point in time or over time as services are provided. , Commission Guidance regarding Accounting for Sale of Vaccines and BioTerror Countermeasures to the Federal Government for Placement into the Pediatric Vaccine Stockpile or the Strategic National Stockpile (SNS). The Company has estimated deferred cost of approximately $52,000 and $64,000 as of September 30, 2022 and December 31, 2021, respectively, for the rotation cost of the product. Such amounts are recorded in other current liabilities and other long-term liabilities as of September 30, 2022, and December 31, 2021, respectively. Contract Liabilities The Company receives payments from customers based on contractual terms. Trade receivables are recorded when the right to consideration becomes unconditional. The Company satisfies its performance obligation on product sales when the products are shipped or delivered, depending on the terms of the sale. Payment terms on invoiced amounts are typically 30-90 days, and do not include a financing component. Contract liabilities are recorded when the Company receives payment prior to satisfying its obligation to transfer goods to a customer. Cost of Sales Cost of sales related to products includes costs to manufacture or purchase, package, and ship the Company’s products. Costs also include relevant production overhead and depreciation and amortization. These costs are recognized when control of the product is transferred to the customer and revenue is recognized. Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income or loss in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that a portion of the deferred tax asset will not be realized. We recognize interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying consolidated statement of operations. Accrued interest and penalties are included on the related tax liability line in the Consolidated Balance Sheets. The Company reviews its uncertain tax positions regularly. An uncertain tax position represents the Company’s expected treatment of a tax position taken in a filed return or planned to be taken in a future tax return or claim that has not been reflected in measuring income tax expense for financial reporting purposes. The Company recognizes the tax benefit from an uncertain tax position when it is more-likely-than-not that the position will be sustained upon examination on the basis of the technical merits or the statute of limitations for the relevant taxing authority to examine and challenge the tax position has expired. Cash and Cash Equivalents Consists of cash held at deposit institutions and 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 money market funds. The Company holds cash at deposit institutions in the amount of $6.2 million and $4.4 million of which $296,000 and $203,000 is denominated in foreign currencies in foreign institutions as of September 30, 2022 and December 31, 2021, respectively. As of September 30, 2022 and December 31, 2021, the Company held cash equivalents in the amount of $17.4 million and $51.1 million, respectively. Restricted Cash Pursuant to a contractual agreement to maintain the business credit card, the Company must maintain restricted cash deposits which amounted to approximately $202,000 and $201,000 as of September 30, 2022 and December 31, 2021, 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, BARDA receivables and other receivables. As of September 30, 2022 and December 31, 2021, substantially all of the Company’s cash was deposited in accounts at financial institutions, and amounts may exceed federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository institutions in which its cash is held. As of September 30, 2022, no single commercial customer accounted for more than 10% of total net accounts receivable. As of December 31, 2021, one commercial customer accounted for approximately 10% of net accounts receivable. September 30, 202 2 and 2021 , BARDA revenue for emergency deployment accounted for approximately 1 % and 30 % of total revenues, respectively. B ARDA receivables for emergency preparedness services accounted for 2 % and 3 % of total BARDA receivables as of September 3 0 , 2022 and December 31 , 2021, respectively. See table below for breakdown of BARDA receivables (in thousands). As of September 30, 2022 As of December 31, 2021 BARDA procurement and emergency preparedness services $ 15 $ 9 BARDA expense reimbursements 777 299 Total BARDA receivables $ 792 $ 308 Marketable Securities We classify all highly liquid investments with original maturities of three months or less from the date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months as marketable securities. The Company classifies marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date, and as long-term when the investments have remaining contractual maturities of more than one year from the balance sheet date. Classification is determined at the time of purchase and re-evaluated each balance sheet date. Short-term marketable securities represent investment of cash available for current operations. We account for our marketable securities as available-for-sale securities. All marketable securities, which consist of corporate debt securities, U.S government agency obligations, U.S treasury and commercial paper are denominated in the U.S. dollars, have been classified as “available for sale”, and are carried at fair value. Unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income (loss) and reported as a separate component of shareholders equity until realized. Realized gains and losses on marketable securities are included in other income in the accompanying consolidated statements of operations. The cost of any marketable securities sold is based on the specific identification method. The amortized cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity. Interest on marketable securities is included in other income. In accordance with the Company’s investment policy, management invests to diversify credit risk and only invests in securities with high credit quality, including U.S. government securities, and the maximum final maturity from the date of purchase is thirty-seven months. If necessary, the Company will recognize an allowance for credit losses on available-for-sale debt securities on an individual basis, and will no longer consider other than-temporary impairment or immediately reduce the cost basis of the investment provided that it is more likely than not that the security will be held to recovery or maturity. Further, the Company will recognize any improvements in estimated credit losses on available-for-sale debt securities immediately in earnings and reduce the existing allowance for credit losses. The Company will disaggregate its available-for-sale debt securities into the following categories: commercial paper, corporate debt, government and agency securities, asset backed securities and money market funds. The Company’s corporate bonds are comprised of predominantly high-grade corporate bonds while its government and agency securities are U.S. treasury bonds, and U.S. agency bonds. The Company has analyzed both corporate bonds and government and agency securities and identified that both types of securities have similar risk characteristics in that they are traded infrequently and have contractual interest rates and maturity dates. To evaluate for impairment, management reviews credit rating changes, securities trends, interest rate movements and unrealized loss at the security level of the Company’s available for sale debt securities. If any of these give rise to a potential credit concern, the Company performs a discounted cash flow analysis to determine the credit portion of the impairment. The discounted cash flow analysis will be performed either internally or through the assistance of a qualified third party. Once the credit component of the impairment is determined, the Company will record the impaired amount as an allowance to the available-for-sale debt securities balance and as a charge to other income in the accompanying consolidated statements of operations, not to exceed the amount of the unrealized loss. The Company assesses expected credit losses at the end of each reporting period and adjusts the allowance through other income. BARDA Income and Receivables The AVITA Group was awarded a Biomedical Advance Research and Development Authority (“ BARDA The Company has concluded that grants under the BARDA arrangement are not within the scope of ASC 606, as it does not meet the definition of a contract with a “customer.” The Company has further concluded that Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition also does not apply, as the Company is a business entity and the payments are with governmental agencies or units. With respect to the BARDA arrangement, we considered the guidance in IAS 20, Accounting for Government Grants and Disclosure of Government Assistance, by analogy. BARDA income and related receivables are recognized when there is reasonable assurance that the amount will be received, and all attaching conditions have been complied with. When the payment relates to an expense item, the amount received is recognized as income over the period when the expense was incurred. Leases The Company has operating leases for corporate office space, manufacturing and a warehouse facility. The Company’s operating leases have remaining lease terms of one year to two years, some of which include options to renew the lease. At contract inception, the Company determines whether the contract is a lease or contains a lease. A contract contains a lease if the Company is both able to identify an asset and can conclude it has the right to control the identified asset for a period of time. Leases with an initial term of twelve months or less are not recorded on the Consolidated Balance Sheets. Right-of-use (“ ROU IBR The Company’s lease terms are only for periods in which it has enforceable rights. A lease is no longer enforceable when both the lessee and the lessor each have the right to terminate the lease without permission from the other party with no more than an insignificant penalty. The Company has options to renew some of these leases for three years after their expiration. The Company considers these options, which may be elected at the Company’s sole discretion, in determining the lease term on a lease-by-lease basis. Lease expense is recognized on a straight-line basis over the lease term and is primarily included in general and administrative expenses in the accompanying consolidated statements of operations. The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component for all underlying asset classes. Some leases require variable payments for common area maintenance, property taxes, parking, insurance and other variable costs. The variable portion of lease payments is not included in operating lease assets or liabilities. Variable lease costs are expensed when incurred. Share-based compensation The Company records compensation expense for stock options based on the fair market value of the awards on the date of grant. The fair value of share-based compensation awards is amortized over the vesting period of the award. Compensation expense for performance-based awards is evaluated based on the number of shares ultimately expected to vest, estimated at each grant date based on management’s expectations regarding the relevant performance criteria, if any. The Black-Scholes option pricing model and Monte Carlo Simulation were used to estimate the fair value of the time-based and performance-based options, respectively. To estimate the grant date fair value of the performance vesting employee stock options, we utilized a Monte Carlo simulation-based approach to capture the holder’s expected post-vesting exercise behavior. Specifically, we simulated the Company’s stock price from the valuation date to the maturity of the options on a daily basis using Geometric Brownian Motion, whereby the options are assumed to be early exercised if the simulated stock price exceeded a certain exercise threshold estimated based on empirical research. Under ASU 2016-09, Compensation – Stock Compensation (“ASC 718”) Improvements to Employee Share-Based Payment Accounting • Expected volatility – determined using the average of the historical volatility using daily intervals over the expected term and the derived volatility using the longest term available of 12 months. • Expected dividends - based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future • Expected term – the expected term of the Company’s stock options for tenure only vesting has been determined utilizing the “simplified” method as described in the SEC’s Staff Accounting Bulletin No. 107 relating to share-based compensation. The simplified method was chosen because the Company has limited historical option exercise experience due to its short operating history of awards granted, with the first plan being established in 2016 which was primarily used for e xecutive awards. Further, the Company does not have sufficient history of exercises in the U.S. market given the AVITA Group's recent redomiciliation from Australia to the United States in 2020 . The initial term input of options with a performance condition was set to the contractual term of 10 years for the modeling process, while the expected term within each simulation path was determined by the early exercise mechanism discussed above within the Monte Carlo simulation model. • Risk-free interest rate – t he risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for a period approximately equal to the expected term of the award. Segment Reporting Operating segments are defined as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company’s chief operating decision-maker is its Chief Executive Officer. To date, the Company has viewed its operations and manages its business as one segment. Non-Qualified Deferred Compensation Plan Liability and Corporate-Owned Life Insurance Asset The Company’s non-qualified deferred compensation plan (the " NQDC plan Compensation – Retirement Benefits Investments – Other Rabbi Trust During April 2022, we established a rabbi trust for a select group of participants in which share awards granted under the 2020 Omnibus Incentive Plan (“2020 Plan”) and deferred under the NQDC plan may be deposited. In addition to the deferral of shares, the rabbi trust holds the assets in the COLI for the NQDC plan. The rabbi trust is an irrevocable trust and no portion of the trust fund may be used for any purpose other than the delivery of those assets to the participants. The assets held in the rabbi trust are subject to the claims of our general creditors in the event of bankruptcy or insolvency. The value of the assets of the rabbi trust is consolidated into our financial statements. The NQDC plan permits diversification of vested shares (common stock) into other equity securities subject to a six-month and one day holding period subsequent to vesting. Per ASC 710-10-25-15, accounting for deferred common stock will be under plan type C or D. Accounting will depend on whether or not the employee has diversified the common stock. Under Plan type C, diversification is permitted but the employee has not diversified. Under Plan type D, diversification is permitted and the employee has diversified. For common stock that have not been diversified, the employer stock held in the rabbi trust is classified in a manner similar to treasury stock and presented separately on the Consolidated Balance Sheets as Company common stock held by the non-qualified deferred compensation plan. Common stock will be recorded at fair value of the stock at the time it vested, subsequent changes in the value of the common stock will not be recognized. The deferred compensation obligation is measured independently at fair value of the common stock with a corresponding charge or credit to compensation cost. Fair value is determined as the product of the common stock and the closing price of the stock each reporting period. Under plan type D, assets held by the rabbi trust are subject to applicable GAAP. As diversified common stock will be invested in mutual funds, assets held by the rabbi trust will be subject to accounting in ASC 321 - Investments - Equity Securities. The deferred compensation obligation is measured independently at fair value of the underlying assets. As of September 30, 2022, deferred common stock has not been diversified. Non-qualified deferred compensation share awards In accordance with ASC 718, Compensation — Stock Compensation, the deferred RSU awards under the NQDC plan are classified as an equity instrument and changes in fair value of the amount owed to the participant are not recognized. As the plan permits diversification, presentation outside of permanent equity in accordance with ASR 268, Redeemable Preferred Stock is appropriate. The redemption amounts are based on the vested percentage and are recorded outside of equity as non-qualified deferred compensation share awards on the Consolidated Balance Sheets. Deferred awards will be presented outside of permanent equity until the awards are vested. As of September 30, 2022, a total of 253,048 shares awards have been deferred with a redemption value of |
Accounting Standards Update
Accounting Standards Update | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Changes And Error Corrections [Abstract] | |
Accounting Standards Update | 3. Accounting Standards Update Recently Adopted Accounting Pronouncements In November 2021, the FASB issued ASU 2021-10, “ Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes Income Taxes The Company adopted this standard as of January 1, 2022. The adoption did not have a material impact on the consolidated financial statements. Recent Accounting Pronouncements Not Yet Adopted All other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Available For Sale Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities The following table summarizes the amortized cost and estimated fair values of debt securities available for sale: As of September 30, 2022 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Carrying Value (in thousands) Cash Equivalents: Money market funds $ 17,425 $ - $ - $ 17,425 Current marketable securities: U.S Treasury securities $ 44,875 $ 1 $ (539 ) $ 44,337 Commercial paper 11,055 - - 11,055 Corporate debt securities 3,317 - (33 ) 3,284 U.S Government Agency Obligations 1,902 - (19 ) 1,883 Total current marketable securities $ 61,149 $ 1 $ (591 ) $ 60,559 Long-term marketable securities: U.S Treasury securities $ 2,887 $ - $ (21 ) $ 2,866 Corporate debt securities 557 - (12 ) 545 Asset backed securities 604 - (3 ) 601 Total Long-term marketable securities $ 4,048 $ - $ (36 ) $ 4,012 As of December 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Carrying Value (in thousands) Cash Equivalents: Money market funds $ 51,112 $ - $ - $ 51,112 Current marketable securities: Commercial paper $ 19,586 $ - $ - $ 19,586 Corporate debt securities 7,068 - (7 ) 7,061 Asset-backed securities 3,002 - - 3,002 Total current marketable securities $ 29,656 $ - $ (7 ) $ 29,649 Long-term marketable securities: U.S Treasury securities $ 18,043 $ - $ (89 ) $ 17,954 Corporate debt securities 1,746 - (8 ) 1,738 Total Long-term marketable securities $ 19,789 $ - $ (97 ) $ 19,692 The maturities of debt securities available for sale 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 September 30, 2022 As of December 31, 2021 Amortized Cost Carrying Value Amortized Cost Carrying Value Due in one year or less $ 61,149 $ 60,559 $ 29,656 $ 29,649 Due after one year through three years $ 4,048 $ 4,012 $ 19,789 $ 19,692 Gross unrealized gains and losses on the Company’s marketable securities were an unrealized gain of $1,000 and an unrealized loss of $627,000 as of September 30, 2022, which resulted in a net unrealized loss of $626,000. Gross unrealized gains and losses on the Company’s marketable securities were an unrealized gain of $0 and an unrealized loss of $104,000 as of December 31, 2021 which resulted in a net unrealized loss of $104,000. As of September 30, 2022, and December 31, 2021, the Company did not recognize credit losses. The Company has accrued interest income of $146,000 and $72,000 as of September 30, 2022, and December 31, 2021, respectively, recorded in prepaids and other current assets. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements 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: As of September 30, 2022 (in thousands) Level 1 Level 2 Level 3 Total Cash Equivalents Money market funds $ 17,425 $ - $ - $ 17,425 Total cash equivalents 17,425 - - 17,425 Short-term marketable securities U.S Treasury securities - 44,337 - 44,337 Commercial paper - 11,055 - 11,055 Corporate debt securities - 3,284 - 3,284 U.S Government Agency Obligations - 1,883 - 1,883 Total short-term marketable securities - 60,559 - 60,559 Long-term investments U.S Treasury securities - 2,866 - 2,866 Corporate debt securities - 545 - 545 Asset backed securities - 601 - 601 Total long-term marketable securities - 4,012 - 4,012 Total marketable securities and cash equivalents $ 17,425 $ 64,571 $ - $ 81,996 As of December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Cash Equivalents Money market funds $ 51,112 $ - $ - $ 51,112 Total cash equivalents 51,112 - - 51,112 Short-term marketable securities Commercial paper - 19,586 - 19,586 Corporate debt securities - 7,061 - 7,061 Asset-backed securities - 3,002 - 3,002 Total short-term marketable securities - 29,649 - 29,649 Long-term investments U.S Treasury securities - 17,954 - 17,954 Corporate debt securities - 1,738 - 1,738 Total long-term marketable securities - 19,692 - 19,692 Total marketable securities and cash equivalents $ 51,112 $ 49,341 $ - $ 100,453 The Company’s Level 1 assets include money market instruments and are valued based upon observable market prices. Level 2 assets consist of commercial paper, U.S Government agency obligations, corporate debt securities, asset backed securities and U.S Treasury securities. Level 2 securities are valued based upon observable inputs that include reported trades, broker/dealer quotes, bids and offers. As of September 30, 2022 and December 31, 2021, the Company had no investments that were measured using unobservable (Level 3) inputs. There were no transfers between fair value measurement levels as of September 30, 2022 or December 31, 2021. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | 6. Leases During August 2021, the Company remeasured the lease liability for an office lease due to a change in the lease term. As a result of the remeasurement of the lease liability, there was an increase of approximately $392,000 to the operating lease ROU assets and operating lease liabilities. There was no impact on earnings as a result of the modification. The following table sets forth the Company’s operating lease expenses which are included in general and administrative expenses in the consolidated statements of operations (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Operating lease cost $ 194 $ 188 $ 582 $ 560 Variable lease cost 13 12 38 36 Total lease cost $ 207 $ 200 $ 620 $ 596 Supplemental cash flow information related to operating leases for the three and nine-months ended September 30, 2022 and 2021 was as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows from operating leases $ 201 $ 192 $ 598 $ 575 Supplemental balance sheet information, as of September 30, 2022 and December 31, 2021 related to operating leases was as follows (in thousands): As of September 30, 2022 As of December 31, 2021 Reported as: Operating lease right-of-use assets $ 1,029 $ 1,544 Total right-of-use assets $ 1,029 $ 1,544 Other current liabilities: Operating lease liabilities, short-term $ 702 $ 720 Operating lease liabilities, long term 405 918 Total operating lease liabilities $ 1,107 $ 1,638 Operating lease weighted average remaining lease term (years) 1.64 2.30 Operating lease weighted average discount rate 6.64 % 6.51 % As of September 30, 2022, maturities of the Company’s operating lease liabilities are as follows (in thousands): Operating Leases Remainder of 2022 $ 205 2023 649 2024 314 Total lease payments 1,168 Less imputed interest (61 ) Total operating lease liabilities $ 1,107 As of September 30, 2022, there were no leases entered into that had not yet commenced. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | 7. Inventory The composition of inventory is as follows (in thousands): As of September 30, 2022 As of December 31, 2021 Raw materials $ 1,384 $ 1,222 Work in process 209 176 Finished goods 367 734 Total inventory $ 1,960 $ 2,132 The Company has reduced the carrying value of 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 $125,000 and $46,000, for the three-months ended September 30, 2022 and 2021, respectively. Charges for estimated excess and obsolescence were $284,000 and $288,000 for the nine-months ended September 30, 2022 and 2021, respectively. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | 8. Intangible Assets The composition of intangible assets, net is as follows (in thousands): As of September 30, 2022 As of December 31, 2021 Weighted Average Life Gross Amount Accumulated Amortization Net Carry Amount Gross Amount Accumulated Amortization Net Carry Amount Patent 1 2 $ 211 $ (210 ) $ 1 $ 209 $ (182 ) $ 27 Patent 2 13 137 (25 ) 112 123 (18 ) 105 Patent 3 14 192 (37 ) 155 192 (25 ) 167 Patent 5 19 71 (5 ) 66 46 (3 ) 43 Patent 6 20 44 (3 ) 41 39 (2 ) 37 Patent 7 13 2 - 2 2 - 2 Patent 8 19 13 - 13 3 - 3 Patent 10 19 3 - 3 3 - 3 Patent 11 19 6 - 6 6 - 6 Trademarks Indefinite 50 - 50 50 - 50 Total intangible assets $ 729 $ (280 ) $ 449 $ 673 $ (230 ) $ 443 During the three and nine-months ended September 30, 2022, 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 was no impairment of intangibles assets recognized for the three and nine-months ended September 30, 2022. During the three and nine-months ended September 30, 2021, the Company recorded an impairment charge of $19,000 for an abandoned patent. Amortization expense of intangibles included in the consolidated statements of operations was $8,000 and $27,000 for the three-months ended September 30, 2022 and 2021, respectively. Amortization expense of intangibles included in the consolidated statements of operations was $50,000 and $88,000 for the nine-months ended September 30, 2022 and 2021, respectively The Company expects the future amortization of amortizable intangible assets held at September 30, 2022 to be as follows (in thousands): Estimated Amortization Expense 2023 $ 33 2024 32 2025 32 2026 32 2027 32 Thereafter 238 Total $ 399 |
Plant and Equipment
Plant and Equipment | 9 Months Ended |
Sep. 30, 2022 | |
Property Plant And Equipment [Abstract] | |
Plant and Equipment | 9. Plant and Equipment The composition of property, plant and equipment, net is as follows (in thousands): Useful Lives As of September 30, 2022 As of December 31, 2021 Computer equipment 3 years $ 734 $ 740 Computer software 3 years 871 811 Construction in progress 181 29 Furniture and fixtures 7 years 440 440 Laboratory equipment 5 years 643 566 Leasehold improvements Lesser of life or lease term 257 242 RECELL Moulds 5 years 129 129 Less: accumulated amortization and depreciation (2,029 ) (1,695 ) Total plant and equipment, net $ 1,226 $ 1,262 Depreciation expense related to plant and equipment for the three-months ended September 30, 2022 and 2021 was $130,000 and $147,000, respectively. Depreciation expense related to plant and equipment for the nine-months ended September 30, 2022 and 2021 was $388,000 and $429,000, respectively. |
Other Current and Long-Term Ass
Other Current and Long-Term Assets and Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Other Current And Long Term Assets And Liabilities [Abstract] | |
Other Current and Long-Term Assets and Liabilities | 10. Other Current and Long-Term Assets and Liabilities Prepaids and other current assets consisted of the following (in thousands): As of September 30, 2022 As of December 31, 2021 Prepaid expenses $ 862 $ 1,124 Lease deposits 16 2 Accrued investment income 146 72 Other receivables 17 15 Total prepaids and other current assets $ 1,041 $ 1,213 Prepaid expenses primarily consist of prepaid benefits and insurance. Other long-term assets consisted of the following (in thousands): As of September 30, 2022 As of December 31, 2021 BARDA contract costs $ 315 $ 504 Long-term lease deposits 121 124 Long-term prepaids 112 10 Total other long-term assets $ 548 $ 638 Other current liabilities consisted of the following (in thousands): As of September 30, 2022 As of December 31, 2021 Operating lease liability $ 702 $ 720 Unsettled investment trade payable 480 - Other current liabilities 437 355 Total other current liabilities $ 1,619 $ 1,075 |
Reporting Segment and Geographi
Reporting Segment and Geographic Information | 9 Months Ended |
Sep. 30, 2022 | |
Segment Reporting [Abstract] | |
Reporting Segment and Geographic Information | 11. Reporting Segment and Geographic Information The Company views its operations and manages its business in one reporting segment. Long-lived assets are primarily located in the United States as of September 30, 2022, and December 31, 2021 with an insignificant amount located in Australia and the United Kingdom. Revenue by region for the three and nine-months ended September 30, 2022, and 2021 were as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Revenue: United States $ 8,996 $ 6,924 $ 24,672 $ 25,888 Foreign: Australia 57 66 173 141 United Kingdom 39 30 121 60 Total $ 9,092 $ 7,020 $ 24,966 $ 26,089 Revenue and cost of sales by customer type for the three and nine-months ended September 30, 2022, and 2021 were as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Revenue: Commercial sales $ 8,999 $ 6,928 $ 24,687 $ 18,249 BARDA: Product sales - - - 7,594 Services for emergency preparedness 93 92 279 246 Total $ 9,092 $ 7,020 $ 24,966 $ 26,089 Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Cost of sales Commercial cost $ 1,446 $ 1,006 $ 4,453 $ 3,187 BARDA: Product cost - - (12 ) 1,889 Emergency preparedness service cost 84 82 253 211 Total $ 1,530 $ 1,088 $ 4,694 $ 5,287 |
Contingencies
Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Contingencies | 12. 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 to be a better estimate 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 September 30, 2022 and December 31, 2021, the Company did not have any outstanding or threatened litigation that would have a material impact to the financial statements. |
Common and Preferred Stock
Common and Preferred Stock | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Common and Preferred Stock | 13. 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 As a result of the ‘implicit consolidation’ that occurred under the AVITA group’s redomiciliation from Australia to the United States of America in 2020 (the “Redomiciliation”), the number of shares of common stock on issue in the Company (as set out in the consolidated financial statements) is less than the number of ordinary shares in AVITA Medical (the prior parent company of the AVITA group) that was previously set out in the consolidated financial statements of AVITA Medical. All common share amounts included in the consolidated financial statements have been retroactively reduced by a factor of one hundred and all per share amounts have been increased by a factor or one hundred, with the exception of the Company’s common stock par value. 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 September 30, 2022, and December 31, 2021, 25,030,902 On March 1, 2021, the Company issued 3,214,250 shares of common stock at the offering price of $21.50 per share. The gross proceeds from the offering were approximately $69.1 million while the Company incurred $5.1 million in capital issuance expenses. The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-249419) that was previously filed with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and declared effective on October 16, 2020. It was also publicly released on the ASX. The final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on February 25, 2021 (in the United States) and released on the ASX on March 1, 2021 (in Australia). |
Revenues
Revenues | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Performance Obligation [Abstract] | |
Revenues | 14. Revenues Revenues The Company’s revenue consists of sale of the RECELL System to hospitals or other treatment centers (“commercial customers”) and to BARDA (collectively “ customers Performance Obligations For commercial contracts, we identified the hospital or treatment center as the customer in Step 1 of the 5-step model of ASC 606 and have determined a contract exists with those customers. As these contracts typically have a single performance obligation (i.e. product delivery), no allocation of the transaction price is required in Step 4 of the model. Control of the product is transferred to the customer at a point in time, at the point in time at which the goods are either shipped or delivered to our customers’ facilities, depending on the terms of the contract. The transaction price is stated within the contract and is therefore fixed consideration. The transaction price does not include the sales tax that is imposed by governmental authorities. For the contract with BARDA, the Company identified two performance obligations (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. Remaining Performance Obligations Revenues from remaining performance obligations are calculated as the dollar value of the remaining performance obligations on executed contracts. 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 $740,000 and $952,000 as of September 30, 2022 and December 31, 2021, respectively. Approximately $308,000 for September 30, 2022 and $517,000 for December 31, 2021 of the total balance relates to our July 2020 contract with BARDA for the purchase, delivery and storage of RECELL Systems for emergency response preparedness for a period of three years. The Company expects to recognize this amount as services are provided to BARDA. For the remaining balance of $432,000 and $435,000 as of September 30, 2022 and December 31, 2021, respectively, the Company expects to recognize revenue on a straight-line basis over the term of the contract commencing with the generation of commercial sales to COSMOTEC. Variable Consideration The Company evaluates its contracts with customers for forms of variable consideration, which may require an adjustment to the transaction price based on their estimated impact. For commercial customers, revenue from the sale of goods is recognized net of volume discounts. The Company uses the expected value method when estimating variable consideration. Revenue is only recognized to the extent that it is probable that a significant reversal will not occur. Variable consideration under the BARDA contract is not material to the consolidated financial statements. 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 the period ended September 30, 2022 and December 31, 2021, the Company does not 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 $740,000 and $952,000 of contract liabilities as of September 30, 2022 and December 31, 2021, respectively. The balance relates to the unsatisfied performance obligation for emergency preparedness under the BARDA contract and COSMOTEC. The performance obligation will be satisfied, and revenue will be recognized over time over the term of the contract. For the three-months ended September 30, 2022 and 2021, the Company recognized $93,000 and $92,000 of revenue from BARDA and $3,000 and $0 for COSMOTEC of the amounts included in the beginning balance of contract liabilities. For the nine-months ended September 30, 2022, and 2021, the Company recognized $279,000 and $246,000 of revenue from BARDA and $3,000 and $0 for COSMOTEC from amounts included in the beginning balance of contract liabilities. Cost to Obtain and Fulfill a Contract Commercial contract fulfillment costs include commissions and shipping expenses. The Company has opted to immediately expense the incremental cost of obtaining a contract when the underlying related asset would have been amortized over one year or less. The Company generally does not incur costs to obtain new contracts. BARDA Contract Costs Cost to fulfill the BARDA emergency preparedness performance obligation, which primarily consist of billed costs to BARDA incurred in connection with the emergency deployment services, are incremental and expected to be recovered. Costs are capitalized and amortized on a straight-line basis over the term of the contract. As of September 30, 2022, and December 31, 2021, the Company had Disaggregated Revenue The Company disaggregates revenue from contracts with customers into geographical regions and by customer type. As noted in the segment footnote, the Company’s business consists of one reporting segment. A reconciliation of disaggregated revenue by geographical region and customer type is provided in Segment Note 11. |
Share-Based Payment Plans
Share-Based Payment Plans | 9 Months Ended |
Sep. 30, 2022 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Payment Plans | 15. Share-Based Payment Plans Overview of Employee Share-Based Compensation Plans Our former parent company, AVITA Medical, adopted the Employee Share Plan and the Incentive Option Plan (collectively, the “ 2016 Plans 2020 Plan Former CEO The 2020 Plan provides for the grant of the following Grants: (a) Incentive Stock Options, (b) Nonstatutory Stock Options, (c) Stock Appreciation Rights, (d) Restricted Stock Grants, (e) Restricted Stock Unit Grants, (f) Performance Grants, and (g) Other Grants. The 2020 Plan will be administered by the Compensation Committee or by the Board acting as the Compensation Committee. Subject to the general purposes, terms and conditions of the 2020 Plan, applicable law and any charter adopted by the Board governing the actions of the Compensation Committee, the Compensation Committee will have full power to implement and carry out the 2020 Plan. Without limitation, the Compensation Committee will have the authority to interpret the plan, approve persons to receive grants, determine the terms and number of shares of the grants, determine vesting and exercisability of grants, and make all other determinations necessary or advisable in connection with the administration of this Plan. The contractual term of awards granted under the 2020 Plan is ten years from the date of its grant. Unless otherwise specified, the vesting period of awards granted under the 2020 Plan was: (i) vest over a four-year Share-Based Payment Expenses Share-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 The Company has included share-based compensation expense as part of operating expenses in the accompanying consolidated statements of operations as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Sales and marketing expenses $ 408 $ 291 $ 1,022 $ 592 General and administrative expenses 761 1,251 4,071 3,353 Research and development expenses 267 300 689 640 Total $ 1,436 $ 1,842 $ 5,782 $ 4,585 A summary of share option activity as of September 30, 2022, and changes during the period ended is presented below: Service Only Share Options Performance Based Share Options Market Awards Total Share Options Outstanding shares at December 31, 2021 1,129,126 599,994 27,600 1,756,720 Granted 456,300 - - 456,300 Exercised (125 ) - - (125 ) Expired (5,025 ) (6,900 ) (27,600 ) (39,525 ) Forfeited (41,175 ) - - (41,175 ) Outstanding shares at September 30, 2022 1,539,101 593,094 - 2,132,195 Exercisable at September 30, 2022 668,137 364,258 - 1,032,395 Restricted Stock Units Restricted stock units (“ RSUs AGM A summary of the status of the Company’s unvested RSUs as of September 30, 2022, and changes that occurred during the year is presented below: Service Condition RSU Performance Condition RSU Market Condition Total RSU's Unvested RSUs outstanding at December 31, 2021 114,757 135,093 47,640 297,490 Granted 334,450 - - 334,450 Vested (47,507 ) (57,527 ) - (105,034 ) Forfeited (5,850 ) (11,920 ) (47,640 ) (65,410 ) Unvested RSUs outstanding at September 30, 2022 395,850 65,646 - 461,496 2019 On November 2019, the equivalent of 395,542 RSUs were issued to the Former CEO with the following vesting terms: a) Tenure – the equivalent of 142,521 RSUs with a vesting period of three-years b) Milestone performance – 253,021 of the RSUs would vest upon satisfaction of various performance conditions. During the first quarter of 2022 the last performance milestone was achieved, the RSUs vested and were appropriately released. As of September 30, 2022, no RSUs are outstanding from this award. 2021 AGM Awards On December 22, 2021, as part of the Company’s 2021 AGM, the Company’s stockholders approved the grant of stock option awards and RSUs to the Former CEO and the Board of Directors. These awards are referred to as the 2021 AGM Awards. Awards to the Former CEO under the 2021 AGM Awards On December 22, 2021, the Former CEO was issued an aggregate 150,480 options and RSUs comprising: • 37,600 • 37,640 o 9,410 options) - Achieve Centers for Medicare and Medicaid Services reimbursement for out-patient transitional pass-through payment code (“ TPT ”) by June30, 2022. This performance condition was met during the quarter ended March 31, 2022 resulting in the 5,960 RSUs vesting and 5,960 shares of common stock being issued in respect of those vested RSUs, as well as the 3,450 options vesting (although those vested options have not been exercised by the Former CEO as at the date of this Form 10-Q). o 9,410 PMDA ”) and reimbursement code by September 30, 2022. This performance condition was met during the quarter ended September 30, 2022, resulting in the RSUs vesting and 5,960 shares of common stock being issued in respect of those vested RSUs, as well as the 3,450 options vesting (although those vested options have not been exercised by the Former CEO as at the date of this Form 10-Q). o 9,410 o 9,410 • 75,240 o 37,620 (23,820 RSUs and 13,800 options) - Achieve a doubling based on a 10-day volume-weighted average price (“ VWAP o 37,620 In accordance with the terms of the RSU Agreement and Option Agreements with the Former CEO, unvested performance-based and market condition RSUs were forfeited on the date of termination and unvested performance-based and market conditions options expired on the date of termination. Per the terms of the RSU and Option Agreements, RSUs and options that were granted and are tenure-based only will continue to vest as long as the Former CEO continues to provide services to the Company as a Board Member. Awards to the Board of Directors under the 2021 AGM Awards The Board of Director awards that were granted in 2021 consist of an aggregate 68,600 options and RSUs as follows: • 41,400 o 6,900 tenure-based options and RSUs (4,350 RSUs and 2,550 options) were granted to each of the six non-executive board members based on the vesting terms detailed above. • 27,200 1/3 o |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 16. Income Taxes At December 31, 2021, the Company and its subsidiaries had net operating loss carryforwards for federal, state, United Kingdom, and Australian income tax purposes of $122.0 million, $79.7 million, $31.9 million and $38.2 million respectively. The net operating loss carryforwards may be subject to limitation regarding their utilization against taxable income in future periods due to “change of ownership” provisions of the Internal Revenue Code and similar state and foreign provisions. Of these carryforwards, $21.7 million will expire, if not utilized, between 2026 through 2038. The state carryforwards begin to expire between 2026 through 2041. The remaining carryforwards have no expiration. The Company is forecasting current year losses and has full valuation allowances against its deferred tax assets. Tax expense for the three-months ended September 30, 2022 and 2021 of $4,000 and $6,000, respectively, is related to state minimum taxes. Tax expense for the nine-months ended September 30, 2022 and 2021, is $12,000 and $23,000, respectively. In assessing the recoverability of its deferred tax assets, the Company considers whether it is more likely than not that its deferred assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income in those periods in which temporary differences become deductible and/or net operating losses can be utilized. The Company considers all positive and negative evidence when determining the amount of the net deferred tax assets that are more likely than not to be realized. This evidence includes, but is not limited to, historical earnings, scheduled reversal of taxable temporary differences, tax planning strategies and projected future taxable income. Based upon the weight of available evidence including the uncertainty regarding the Company’s ability to utilize certain net operating losses and tax credits in the future, the Company has established a valuation allowance against its net deferred tax assets of $51.3 million and $46.9 million as of December 31, 2021 and 2020, respectively. The deferred tax assets are primarily net operating loss carryforwards for which management has determined it is more likely than not that the deferred tax assets will not be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements related to a particular tax position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon settlement. The amount of unrecognized tax benefits is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. The Company has not identified any uncertain tax positions as of September 30, 2022 or December 31, 2021. The Company files income tax returns in the U.S. federal, California and certain other state and foreign jurisdictions. The Company remains subject to income tax examinations for its U.S. federal and state income taxes generally for fiscal years ended June 30, 2006 and forward. The Company also remains subject to income tax examinations for international income taxes for fiscal years ended June 30, 2018 through June 30, 2021, and for certain other U.S. state and local income taxes generally for the fiscal years ended June 30, 2018 through June 30, 2021. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 17. Net Loss per Share The following is a reconciliation of the basic and diluted loss per share computations: Three-Months Ended September 30, Nine-Months Ended September 30, (in thousands, except per share data) 2022 2021 2022 2021 Net Loss $ (5,588 ) $ (5,948 ) $ (21,312 ) $ (16,663 ) Weighted-average common shares – outstanding, basic 25,007 24,905 24,972 24,175 Weighted-average common shares – outstanding, diluted 25,007 24,905 24,972 24,175 Net loss per common share, basic $ (0.22 ) $ (0.24 ) $ (0.85 ) $ (0.69 ) Net loss per common share, diluted $ (0.22 ) $ (0.24 ) $ (0.85 ) $ (0.69 ) 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, 17,927 shares of common stock held by the rabbi trust are excluded from the denominator in the basic and diluted EPS calculations. For details on shares of common stock held by the rabbi trust refer to Note 18. 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 and nine - months ended September 30 , 2022, and 2021 , diluted net loss per common share is the same as the basic net loss per share for those periods . |
Retirement Plans
Retirement Plans | 9 Months Ended |
Sep. 30, 2022 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plans | 18. Retirement Plans The Company offers a 401(k)-retirement savings plan (the “401(k) Plan” Non-qualified deferred compensation plan The Company’s non-qualified deferred compensation plan (the " NQDC plan two-year 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. The fair values of the Company’s deferred compensation plan assets and liability are included in the table below. For additional information on the fair value hierarchy and the inputs used to measure fair value, see Note 5, Fair Value Measurements. Fair Value as of September 30, 2022 Fair Value as of December 31, 2021 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Corporate-owned life insurance policies (1) - 948 - 948 - 304 - 304 Non-qualified deferred compensation plan liability (2) - 1,016 - 1,016 - 262 - 262 (1) (2) Rabbi Trust During April 2022, we 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 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 Compensation — Stock Compensation 17,927 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. A total of 17,927 shares were vested at the redemption value of $127,000. The following table summarizes the eligible share award activity as of September 30, 2022, and December 31, 2021 (in thousands): As of September 30, 2022 December 31, 2021 Non-qualified deferred compensation share awards: Balance at inception/beginning of period - - Change in classification of deferred compensation share awards 192 - Share-based compensation expense 287 - Change in redemption value (80 ) - Vesting of share awards held by NDQC (127 ) - Ending Balance 272 - |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 19. Subsequent Events The Company has evaluated subsequent events through the filing of this Quarterly Report on Form 10-Q and determined that there have been no events that have occurred that would require adjustments to our disclosures in the consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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 SEC ASX Transition Report There have been no changes to the Company’s significant accounting policies as described in the T ransition R eport on Form 10-K T 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 Transition Report. |
Principles of Consolidation | 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. |
Reclassification of Prior Year Presentation | Reclassification of Prior Year Presentation Certain prior year amounts within other long-term assets and other long-term liabilities have been reclassified to Corporate-owned life insurance asset and Non-qualified deferred compensation plan liability, respectively, in the Consolidated Balance Sheets, for consistency with current period presentation. These reclassifications had no effect on the reported results of operations or financial position. |
Use of Estimates | Use of Estimates The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts (including doubtful accounts, carrying value of long-lived assets, the useful lives of long-lived assets, accounting for marketable securities, income taxes, share-based compensation, and the stand-alone selling price for the BARDA contract) 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 | 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 accumulated other comprehensive gain (loss) in shareholders’ equity. Gains and losses resulting from foreign currency transactions are included in general and administrative expenses and were a gain of $76,000 and $41,000 for the three-months ended September 30, 2022 and 2021, respectively. Foreign currency transactions were a gain of $123,000 and $58,000 for the nine-months ended September 30, 2022 and 2021, respectively. 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 and foreign currency transactions are included in general and administrative expenses. During the three-months ended September 30, 2022 and 2021, the Company recorded gains of $6,000 and a loss of $14,000, respectively. The Company recorded losses of $2,000 and $30,000 for the nine-months ended September 30, 2022 and 2021, respectively. |
Comprehensive Loss | Comprehensive Loss The components of comprehensive loss consist of net loss, foreign currency translation adjustments from its subsidiaries not using the U.S. dollar as their functional currency and unrealized gains and losses in investments available for sale. The Company did not have reclassifications from other comprehensive loss to net loss during the three and nine-months ended September 30, 2022. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of Accounting Standard Codification (“ASC”) Topic 606, Revenue Recognition, the Company performs the following five steps: 1. Identify the contract with a customer 2. Identify the performance obligations 3. Determine the transaction price 4. Allocate the transaction price to the performance obligations 5. Recognize revenue when/as performance obligation(s) are satisfied In order for an arrangement to be considered a contract, it must be probable that the Company will collect the consideration to which it is entitled for goods or services to be transferred. Once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised with each contract, determines whether those are performance obligations and the related transaction price. The Company then recognizes the sale of goods based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. The Company’s revenue consists primarily of the sale of the RECELL System to hospitals or other treatment centers and to BARDA (collectively, “customers”), predominately in the United States. The Company evaluated the BARDA contract and concluded that a portion of the arrangement, such as the procurement of the RECELL system and the emergency preparedness, represents a transaction with a customer and as such are in the scope of ASC 606. Amounts received from BARDA for the research and development of the Company’s product are classified as BARDA income in the Consolidated Statements of Operations and are accounted for under IAS 20. For further details refer to BARDA Income and Receivables below. Revenues for commercial customers (hospitals and treatment centers) are recognized as control of the product is transferred to customers, at an amount that reflects the consideration expected to be received in exchange for the product. Revenues are recognized net of volume discounts. As such, revenue is recognized only to the extent a significant reversal of revenues is not expected to occur in subsequent periods. For the Company’s contracts that have an original duration of one year or less, the Company elected the practical expedient applicable to such contracts and does not consider the time value of money. Further, because of the short duration of these contracts, the Company has not disclosed the transaction price for the remaining performance obligations as of each reporting period or when the Company expects to recognize this revenue. The Company has further applied the practical expedient to exclude sales tax in the transaction price and expense contract fulfilment costs such as commissions and shipping and handling expenses as incurred. For revenues related to the BARDA contract within the scope of ASC 606, the Company identified two performance obligations: (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. Through this contract the Company promises to procure the product through a vendor management inventory arrangement and to stand ready to provide emergency deployment services related to the product. Emergency preparedness services include procuring necessary storage containers, housing, and maintaining the containers (and product), and providing shipping and handling services in the event of an emergency situation. This stand ready obligation is a series of distinct services that are substantially the same and have the same pattern of transfer to the customer, overtime as services are consumed. The total transaction price for the portion of the BARDA contract that is within the scope of ASC 606, was determined to be $9.2 million. The transaction price was allocated on a stand-alone selling price basis as follows: $7.6 million to the procurement of the RECELL product, which is classified as Revenues when recognized in the Consolidated Statements of Operations and $1.6 million to the emergency deployment services which is classified as Revenues when recognized in the Consolidated Statements of Operations. The $1.6 million for emergency deployment includes variable consideration which is deemed immaterial to the contract as a whole. The Company estimated the stand-alone selling price of the procurement of the RECELL product based on historical pricing of the Company’s product at the initial execution of the contract. The Company estimated the stand-alone selling price of the emergency deployment services performed based on the Company’s projected cost of providing the services plus an applicable profit margin as denoted in the contract. The Company’s performance obligations are either satisfied at a point in time or over time as services are provided. , Commission Guidance regarding Accounting for Sale of Vaccines and BioTerror Countermeasures to the Federal Government for Placement into the Pediatric Vaccine Stockpile or the Strategic National Stockpile (SNS). The Company has estimated deferred cost of approximately $52,000 and $64,000 as of September 30, 2022 and December 31, 2021, respectively, for the rotation cost of the product. Such amounts are recorded in other current liabilities and other long-term liabilities as of September 30, 2022, and December 31, 2021, respectively. |
Contract Liabilities | Contract Liabilities The Company receives payments from customers based on contractual terms. Trade receivables are recorded when the right to consideration becomes unconditional. The Company satisfies its performance obligation on product sales when the products are shipped or delivered, depending on the terms of the sale. Payment terms on invoiced amounts are typically 30-90 days, and do not include a financing component. Contract liabilities are recorded when the Company receives payment prior to satisfying its obligation to transfer goods to a customer. |
Cost of Sales | Cost of Sales Cost of sales related to products includes costs to manufacture or purchase, package, and ship the Company’s products. Costs also include relevant production overhead and depreciation and amortization. These costs are recognized when control of the product is transferred to the customer and revenue is recognized. |
Income Taxes | Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income or loss in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that a portion of the deferred tax asset will not be realized. We recognize interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying consolidated statement of operations. Accrued interest and penalties are included on the related tax liability line in the Consolidated Balance Sheets. The Company reviews its uncertain tax positions regularly. An uncertain tax position represents the Company’s expected treatment of a tax position taken in a filed return or planned to be taken in a future tax return or claim that has not been reflected in measuring income tax expense for financial reporting purposes. The Company recognizes the tax benefit from an uncertain tax position when it is more-likely-than-not that the position will be sustained upon examination on the basis of the technical merits or the statute of limitations for the relevant taxing authority to examine and challenge the tax position has expired. |
Cash and Cash Equivalents | Cash and Cash Equivalents Consists of cash held at deposit institutions and 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 money market funds. The Company holds cash at deposit institutions in the amount of $6.2 million and $4.4 million of which $296,000 and $203,000 is denominated in foreign currencies in foreign institutions as of September 30, 2022 and December 31, 2021, respectively. As of September 30, 2022 and December 31, 2021, the Company held cash equivalents in the amount of $17.4 million and $51.1 million, respectively. |
Restricted Cash | Restricted Cash Pursuant to a contractual agreement to maintain the business credit card, the Company must maintain restricted cash deposits which amounted to approximately $202,000 and $201,000 as of September 30, 2022 and December 31, 2021, respectively. |
Concentrations | Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, marketable securities, trade receivables, BARDA receivables and other receivables. As of September 30, 2022 and December 31, 2021, substantially all of the Company’s cash was deposited in accounts at financial institutions, and amounts may exceed federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository institutions in which its cash is held. As of September 30, 2022, no single commercial customer accounted for more than 10% of total net accounts receivable. As of December 31, 2021, one commercial customer accounted for approximately 10% of net accounts receivable. September 30, 202 2 and 2021 , BARDA revenue for emergency deployment accounted for approximately 1 % and 30 % of total revenues, respectively. B ARDA receivables for emergency preparedness services accounted for 2 % and 3 % of total BARDA receivables as of September 3 0 , 2022 and December 31 , 2021, respectively. See table below for breakdown of BARDA receivables (in thousands). As of September 30, 2022 As of December 31, 2021 BARDA procurement and emergency preparedness services $ 15 $ 9 BARDA expense reimbursements 777 299 Total BARDA receivables $ 792 $ 308 |
Marketable Securities | Marketable Securities We classify all highly liquid investments with original maturities of three months or less from the date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months as marketable securities. The Company classifies marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date, and as long-term when the investments have remaining contractual maturities of more than one year from the balance sheet date. Classification is determined at the time of purchase and re-evaluated each balance sheet date. Short-term marketable securities represent investment of cash available for current operations. We account for our marketable securities as available-for-sale securities. All marketable securities, which consist of corporate debt securities, U.S government agency obligations, U.S treasury and commercial paper are denominated in the U.S. dollars, have been classified as “available for sale”, and are carried at fair value. Unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income (loss) and reported as a separate component of shareholders equity until realized. Realized gains and losses on marketable securities are included in other income in the accompanying consolidated statements of operations. The cost of any marketable securities sold is based on the specific identification method. The amortized cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity. Interest on marketable securities is included in other income. In accordance with the Company’s investment policy, management invests to diversify credit risk and only invests in securities with high credit quality, including U.S. government securities, and the maximum final maturity from the date of purchase is thirty-seven months. If necessary, the Company will recognize an allowance for credit losses on available-for-sale debt securities on an individual basis, and will no longer consider other than-temporary impairment or immediately reduce the cost basis of the investment provided that it is more likely than not that the security will be held to recovery or maturity. Further, the Company will recognize any improvements in estimated credit losses on available-for-sale debt securities immediately in earnings and reduce the existing allowance for credit losses. The Company will disaggregate its available-for-sale debt securities into the following categories: commercial paper, corporate debt, government and agency securities, asset backed securities and money market funds. The Company’s corporate bonds are comprised of predominantly high-grade corporate bonds while its government and agency securities are U.S. treasury bonds, and U.S. agency bonds. The Company has analyzed both corporate bonds and government and agency securities and identified that both types of securities have similar risk characteristics in that they are traded infrequently and have contractual interest rates and maturity dates. To evaluate for impairment, management reviews credit rating changes, securities trends, interest rate movements and unrealized loss at the security level of the Company’s available for sale debt securities. If any of these give rise to a potential credit concern, the Company performs a discounted cash flow analysis to determine the credit portion of the impairment. The discounted cash flow analysis will be performed either internally or through the assistance of a qualified third party. Once the credit component of the impairment is determined, the Company will record the impaired amount as an allowance to the available-for-sale debt securities balance and as a charge to other income in the accompanying consolidated statements of operations, not to exceed the amount of the unrealized loss. The Company assesses expected credit losses at the end of each reporting period and adjusts the allowance through other income. |
BARDA Income and Receivables | BARDA Income and Receivables The AVITA Group was awarded a Biomedical Advance Research and Development Authority (“ BARDA The Company has concluded that grants under the BARDA arrangement are not within the scope of ASC 606, as it does not meet the definition of a contract with a “customer.” The Company has further concluded that Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition also does not apply, as the Company is a business entity and the payments are with governmental agencies or units. With respect to the BARDA arrangement, we considered the guidance in IAS 20, Accounting for Government Grants and Disclosure of Government Assistance, by analogy. BARDA income and related receivables are recognized when there is reasonable assurance that the amount will be received, and all attaching conditions have been complied with. When the payment relates to an expense item, the amount received is recognized as income over the period when the expense was incurred. |
Leases | Leases The Company has operating leases for corporate office space, manufacturing and a warehouse facility. The Company’s operating leases have remaining lease terms of one year to two years, some of which include options to renew the lease. At contract inception, the Company determines whether the contract is a lease or contains a lease. A contract contains a lease if the Company is both able to identify an asset and can conclude it has the right to control the identified asset for a period of time. Leases with an initial term of twelve months or less are not recorded on the Consolidated Balance Sheets. Right-of-use (“ ROU IBR The Company’s lease terms are only for periods in which it has enforceable rights. A lease is no longer enforceable when both the lessee and the lessor each have the right to terminate the lease without permission from the other party with no more than an insignificant penalty. The Company has options to renew some of these leases for three years after their expiration. The Company considers these options, which may be elected at the Company’s sole discretion, in determining the lease term on a lease-by-lease basis. Lease expense is recognized on a straight-line basis over the lease term and is primarily included in general and administrative expenses in the accompanying consolidated statements of operations. The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component for all underlying asset classes. Some leases require variable payments for common area maintenance, property taxes, parking, insurance and other variable costs. The variable portion of lease payments is not included in operating lease assets or liabilities. Variable lease costs are expensed when incurred. |
Share-based Compensation | Share-based compensation The Company records compensation expense for stock options based on the fair market value of the awards on the date of grant. The fair value of share-based compensation awards is amortized over the vesting period of the award. Compensation expense for performance-based awards is evaluated based on the number of shares ultimately expected to vest, estimated at each grant date based on management’s expectations regarding the relevant performance criteria, if any. The Black-Scholes option pricing model and Monte Carlo Simulation were used to estimate the fair value of the time-based and performance-based options, respectively. To estimate the grant date fair value of the performance vesting employee stock options, we utilized a Monte Carlo simulation-based approach to capture the holder’s expected post-vesting exercise behavior. Specifically, we simulated the Company’s stock price from the valuation date to the maturity of the options on a daily basis using Geometric Brownian Motion, whereby the options are assumed to be early exercised if the simulated stock price exceeded a certain exercise threshold estimated based on empirical research. Under ASU 2016-09, Compensation – Stock Compensation (“ASC 718”) Improvements to Employee Share-Based Payment Accounting • Expected volatility – determined using the average of the historical volatility using daily intervals over the expected term and the derived volatility using the longest term available of 12 months. • Expected dividends - based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future • Expected term – the expected term of the Company’s stock options for tenure only vesting has been determined utilizing the “simplified” method as described in the SEC’s Staff Accounting Bulletin No. 107 relating to share-based compensation. The simplified method was chosen because the Company has limited historical option exercise experience due to its short operating history of awards granted, with the first plan being established in 2016 which was primarily used for e xecutive awards. Further, the Company does not have sufficient history of exercises in the U.S. market given the AVITA Group's recent redomiciliation from Australia to the United States in 2020 . The initial term input of options with a performance condition was set to the contractual term of 10 years for the modeling process, while the expected term within each simulation path was determined by the early exercise mechanism discussed above within the Monte Carlo simulation model. • Risk-free interest rate – t he risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for a period approximately equal to the expected term of the award. |
Segment Reporting | Segment Reporting Operating segments are defined as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company’s chief operating decision-maker is its Chief Executive Officer. To date, the Company has viewed its operations and manages its business as one segment. |
Non-Qualified Deferred Compensation Plan Liability and Corporate-Owned Life Insurance Asset | Non-Qualified Deferred Compensation Plan Liability and Corporate-Owned Life Insurance Asset NQDC plan Compensation – Retirement Benefits Investments – Other |
Rabbi Trust | Rabbi Trust During April 2022, we established a rabbi trust for a select group of participants in which share awards granted under the 2020 Omnibus Incentive Plan (“2020 Plan”) and deferred under the NQDC plan may be deposited. In addition to the deferral of shares, the rabbi trust holds the assets in the COLI for the NQDC plan. The rabbi trust is an irrevocable trust and no portion of the trust fund may be used for any purpose other than the delivery of those assets to the participants. The assets held in the rabbi trust are subject to the claims of our general creditors in the event of bankruptcy or insolvency. The value of the assets of the rabbi trust is consolidated into our financial statements. The NQDC plan permits diversification of vested shares (common stock) into other equity securities subject to a six-month and one day holding period subsequent to vesting. Per ASC 710-10-25-15, accounting for deferred common stock will be under plan type C or D. Accounting will depend on whether or not the employee has diversified the common stock. Under Plan type C, diversification is permitted but the employee has not diversified. Under Plan type D, diversification is permitted and the employee has diversified. For common stock that have not been diversified, the employer stock held in the rabbi trust is classified in a manner similar to treasury stock and presented separately on the Consolidated Balance Sheets as Company common stock held by the non-qualified deferred compensation plan. Common stock will be recorded at fair value of the stock at the time it vested, subsequent changes in the value of the common stock will not be recognized. The deferred compensation obligation is measured independently at fair value of the common stock with a corresponding charge or credit to compensation cost. Fair value is determined as the product of the common stock and the closing price of the stock each reporting period. Under plan type D, assets held by the rabbi trust are subject to applicable GAAP. As diversified common stock will be invested in mutual funds, assets held by the rabbi trust will be subject to accounting in ASC 321 - Investments - Equity Securities. The deferred compensation obligation is measured independently at fair value of the underlying assets. As of September 30, 2022, deferred common stock has not been diversified. |
Non-qualified Deferred Compensation Share Awards | Non-qualified deferred compensation share awards In accordance with ASC 718, Compensation — Stock Compensation, the deferred RSU awards under the NQDC plan are classified as an equity instrument and changes in fair value of the amount owed to the participant are not recognized. As the plan permits diversification, presentation outside of permanent equity in accordance with ASR 268, Redeemable Preferred Stock is appropriate. The redemption amounts are based on the vested percentage and are recorded outside of equity as non-qualified deferred compensation share awards on the Consolidated Balance Sheets. Deferred awards will be presented outside of permanent equity until the awards are vested. As of September 30, 2022, a total of 253,048 shares awards have been deferred with a redemption value of |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Other Receivables | See table below for breakdown of BARDA receivables (in thousands). As of September 30, 2022 As of December 31, 2021 BARDA procurement and emergency preparedness services $ 15 $ 9 BARDA expense reimbursements 777 299 Total BARDA receivables $ 792 $ 308 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Available For Sale Securities [Abstract] | |
Summary of Amortized Cost and Estimated Fair Values of Debt Securities Available for Sale | The following table summarizes the amortized cost and estimated fair values of debt securities available for sale: As of September 30, 2022 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Carrying Value (in thousands) Cash Equivalents: Money market funds $ 17,425 $ - $ - $ 17,425 Current marketable securities: U.S Treasury securities $ 44,875 $ 1 $ (539 ) $ 44,337 Commercial paper 11,055 - - 11,055 Corporate debt securities 3,317 - (33 ) 3,284 U.S Government Agency Obligations 1,902 - (19 ) 1,883 Total current marketable securities $ 61,149 $ 1 $ (591 ) $ 60,559 Long-term marketable securities: U.S Treasury securities $ 2,887 $ - $ (21 ) $ 2,866 Corporate debt securities 557 - (12 ) 545 Asset backed securities 604 - (3 ) 601 Total Long-term marketable securities $ 4,048 $ - $ (36 ) $ 4,012 As of December 31, 2021 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Carrying Value (in thousands) Cash Equivalents: Money market funds $ 51,112 $ - $ - $ 51,112 Current marketable securities: Commercial paper $ 19,586 $ - $ - $ 19,586 Corporate debt securities 7,068 - (7 ) 7,061 Asset-backed securities 3,002 - - 3,002 Total current marketable securities $ 29,656 $ - $ (7 ) $ 29,649 Long-term marketable securities: U.S Treasury securities $ 18,043 $ - $ (89 ) $ 17,954 Corporate debt securities 1,746 - (8 ) 1,738 Total Long-term marketable securities $ 19,789 $ - $ (97 ) $ 19,692 |
Summary of Maturities of Debt Securities Available for Sale | The maturities of debt securities available for sale 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 September 30, 2022 As of December 31, 2021 Amortized Cost Carrying Value Amortized Cost Carrying Value Due in one year or less $ 61,149 $ 60,559 $ 29,656 $ 29,649 Due after one year through three years $ 4,048 $ 4,012 $ 19,789 $ 19,692 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | 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: As of September 30, 2022 (in thousands) Level 1 Level 2 Level 3 Total Cash Equivalents Money market funds $ 17,425 $ - $ - $ 17,425 Total cash equivalents 17,425 - - 17,425 Short-term marketable securities U.S Treasury securities - 44,337 - 44,337 Commercial paper - 11,055 - 11,055 Corporate debt securities - 3,284 - 3,284 U.S Government Agency Obligations - 1,883 - 1,883 Total short-term marketable securities - 60,559 - 60,559 Long-term investments U.S Treasury securities - 2,866 - 2,866 Corporate debt securities - 545 - 545 Asset backed securities - 601 - 601 Total long-term marketable securities - 4,012 - 4,012 Total marketable securities and cash equivalents $ 17,425 $ 64,571 $ - $ 81,996 As of December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Total Cash Equivalents Money market funds $ 51,112 $ - $ - $ 51,112 Total cash equivalents 51,112 - - 51,112 Short-term marketable securities Commercial paper - 19,586 - 19,586 Corporate debt securities - 7,061 - 7,061 Asset-backed securities - 3,002 - 3,002 Total short-term marketable securities - 29,649 - 29,649 Long-term investments U.S Treasury securities - 17,954 - 17,954 Corporate debt securities - 1,738 - 1,738 Total long-term marketable securities - 19,692 - 19,692 Total marketable securities and cash equivalents $ 51,112 $ 49,341 $ - $ 100,453 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Summary Of Lease Cost | The following table sets forth the Company’s operating lease expenses which are included in general and administrative expenses in the consolidated statements of operations (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Operating lease cost $ 194 $ 188 $ 582 $ 560 Variable lease cost 13 12 38 36 Total lease cost $ 207 $ 200 $ 620 $ 596 |
Summary Of Supplemental Cash Flow Information Related To Operating Leases | Supplemental cash flow information related to operating leases for the three and nine-months ended September 30, 2022 and 2021 was as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows from operating leases $ 201 $ 192 $ 598 $ 575 |
Summary Of Supplemental Balance Sheet Information Related To Operating Leases | Supplemental balance sheet information, as of September 30, 2022 and December 31, 2021 related to operating leases was as follows (in thousands): As of September 30, 2022 As of December 31, 2021 Reported as: Operating lease right-of-use assets $ 1,029 $ 1,544 Total right-of-use assets $ 1,029 $ 1,544 Other current liabilities: Operating lease liabilities, short-term $ 702 $ 720 Operating lease liabilities, long term 405 918 Total operating lease liabilities $ 1,107 $ 1,638 Operating lease weighted average remaining lease term (years) 1.64 2.30 Operating lease weighted average discount rate 6.64 % 6.51 % |
Summary Of Maturities Of The Company's Operating Lease Liabilities | As of September 30, 2022, maturities of the Company’s operating lease liabilities are as follows (in thousands): Operating Leases Remainder of 2022 $ 205 2023 649 2024 314 Total lease payments 1,168 Less imputed interest (61 ) Total operating lease liabilities $ 1,107 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Summary Of Composition Of Inventory | The composition of inventory is as follows (in thousands): As of September 30, 2022 As of December 31, 2021 Raw materials $ 1,384 $ 1,222 Work in process 209 176 Finished goods 367 734 Total inventory $ 1,960 $ 2,132 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary Of Composition Of Intangible Assets | The composition of intangible assets, net is as follows (in thousands): As of September 30, 2022 As of December 31, 2021 Weighted Average Life Gross Amount Accumulated Amortization Net Carry Amount Gross Amount Accumulated Amortization Net Carry Amount Patent 1 2 $ 211 $ (210 ) $ 1 $ 209 $ (182 ) $ 27 Patent 2 13 137 (25 ) 112 123 (18 ) 105 Patent 3 14 192 (37 ) 155 192 (25 ) 167 Patent 5 19 71 (5 ) 66 46 (3 ) 43 Patent 6 20 44 (3 ) 41 39 (2 ) 37 Patent 7 13 2 - 2 2 - 2 Patent 8 19 13 - 13 3 - 3 Patent 10 19 3 - 3 3 - 3 Patent 11 19 6 - 6 6 - 6 Trademarks Indefinite 50 - 50 50 - 50 Total intangible assets $ 729 $ (280 ) $ 449 $ 673 $ (230 ) $ 443 |
Summary Of Future Amortization Of Amortizable Intangible Assets Held | The Company expects the future amortization of amortizable intangible assets held at September 30, 2022 to be as follows (in thousands): Estimated Amortization Expense 2023 $ 33 2024 32 2025 32 2026 32 2027 32 Thereafter 238 Total $ 399 |
Plant and Equipment (Tables)
Plant and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property Plant And Equipment [Abstract] | |
Summary of Composition of Property, Plant and Equipment | The composition of property, plant and equipment, net is as follows (in thousands): Useful Lives As of September 30, 2022 As of December 31, 2021 Computer equipment 3 years $ 734 $ 740 Computer software 3 years 871 811 Construction in progress 181 29 Furniture and fixtures 7 years 440 440 Laboratory equipment 5 years 643 566 Leasehold improvements Lesser of life or lease term 257 242 RECELL Moulds 5 years 129 129 Less: accumulated amortization and depreciation (2,029 ) (1,695 ) Total plant and equipment, net $ 1,226 $ 1,262 |
Other Current and Long-Term A_2
Other Current and Long-Term Assets and Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Other Current And Long Term Assets And Liabilities [Abstract] | |
Summary of Prepaids and Other Current Assets | Prepaids and other current assets consisted of the following (in thousands): As of September 30, 2022 As of December 31, 2021 Prepaid expenses $ 862 $ 1,124 Lease deposits 16 2 Accrued investment income 146 72 Other receivables 17 15 Total prepaids and other current assets $ 1,041 $ 1,213 |
Summary of Other Long Term Assets | Other long-term assets consisted of the following (in thousands): As of September 30, 2022 As of December 31, 2021 BARDA contract costs $ 315 $ 504 Long-term lease deposits 121 124 Long-term prepaids 112 10 Total other long-term assets $ 548 $ 638 |
Summary of Other Current Liabilities | Other current liabilities consisted of the following (in thousands): As of September 30, 2022 As of December 31, 2021 Operating lease liability $ 702 $ 720 Unsettled investment trade payable 480 - Other current liabilities 437 355 Total other current liabilities $ 1,619 $ 1,075 |
Reporting Segment and Geograp_2
Reporting Segment and Geographic Information (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Segment Reporting [Abstract] | |
Schedule Of Revenue and Cost Of Sales By Region and Customer Type | Revenue by region for the three and nine-months ended September 30, 2022, and 2021 were as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Revenue: United States $ 8,996 $ 6,924 $ 24,672 $ 25,888 Foreign: Australia 57 66 173 141 United Kingdom 39 30 121 60 Total $ 9,092 $ 7,020 $ 24,966 $ 26,089 Revenue and cost of sales by customer type for the three and nine-months ended September 30, 2022, and 2021 were as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Revenue: Commercial sales $ 8,999 $ 6,928 $ 24,687 $ 18,249 BARDA: Product sales - - - 7,594 Services for emergency preparedness 93 92 279 246 Total $ 9,092 $ 7,020 $ 24,966 $ 26,089 Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Cost of sales Commercial cost $ 1,446 $ 1,006 $ 4,453 $ 3,187 BARDA: Product cost - - (12 ) 1,889 Emergency preparedness service cost 84 82 253 211 Total $ 1,530 $ 1,088 $ 4,694 $ 5,287 |
Share-Based Payment Plans (Tabl
Share-Based Payment Plans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary Of Stock-based Compensation Is Reflected In The Statements Of Operations | The Company has included share-based compensation expense as part of operating expenses in the accompanying consolidated statements of operations as follows (in thousands): Three-months ended September 30, Nine-months ended September 30, 2022 2021 2022 2021 Sales and marketing expenses $ 408 $ 291 $ 1,022 $ 592 General and administrative expenses 761 1,251 4,071 3,353 Research and development expenses 267 300 689 640 Total $ 1,436 $ 1,842 $ 5,782 $ 4,585 |
Summary Of Share Option Activity | A summary of share option activity as of September 30, 2022, and changes during the period ended is presented below: Service Only Share Options Performance Based Share Options Market Awards Total Share Options Outstanding shares at December 31, 2021 1,129,126 599,994 27,600 1,756,720 Granted 456,300 - - 456,300 Exercised (125 ) - - (125 ) Expired (5,025 ) (6,900 ) (27,600 ) (39,525 ) Forfeited (41,175 ) - - (41,175 ) Outstanding shares at September 30, 2022 1,539,101 593,094 - 2,132,195 Exercisable at September 30, 2022 668,137 364,258 - 1,032,395 |
Non Option Restricted Stock Units | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary Of Share Option Activity | A summary of the status of the Company’s unvested RSUs as of September 30, 2022, and changes that occurred during the year is presented below: Service Condition RSU Performance Condition RSU Market Condition Total RSU's Unvested RSUs outstanding at December 31, 2021 114,757 135,093 47,640 297,490 Granted 334,450 - - 334,450 Vested (47,507 ) (57,527 ) - (105,034 ) Forfeited (5,850 ) (11,920 ) (47,640 ) (65,410 ) Unvested RSUs outstanding at September 30, 2022 395,850 65,646 - 461,496 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary Of Reconciliation Of The Basic And Diluted Loss Per Share | The following is a reconciliation of the basic and diluted loss per share computations: Three-Months Ended September 30, Nine-Months Ended September 30, (in thousands, except per share data) 2022 2021 2022 2021 Net Loss $ (5,588 ) $ (5,948 ) $ (21,312 ) $ (16,663 ) Weighted-average common shares – outstanding, basic 25,007 24,905 24,972 24,175 Weighted-average common shares – outstanding, diluted 25,007 24,905 24,972 24,175 Net loss per common share, basic $ (0.22 ) $ (0.24 ) $ (0.85 ) $ (0.69 ) Net loss per common share, diluted $ (0.22 ) $ (0.24 ) $ (0.85 ) $ (0.69 ) |
Retirement Plans (Tables)
Retirement Plans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Compensation And Retirement Disclosure [Abstract] | |
Summary of Fair Values of Company's Deferred Compensation Plan Assets and Liability | The fair values of the Company’s deferred compensation plan assets and liability are included in the table below. For additional information on the fair value hierarchy and the inputs used to measure fair value, see Note 5, Fair Value Measurements. Fair Value as of September 30, 2022 Fair Value as of December 31, 2021 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Corporate-owned life insurance policies (1) - 948 - 948 - 304 - 304 Non-qualified deferred compensation plan liability (2) - 1,016 - 1,016 - 262 - 262 (1) (2) |
Summary of Eligible Share Award Activity | The following table summarizes the eligible share award activity as of September 30, 2022, and December 31, 2021 (in thousands): As of September 30, 2022 December 31, 2021 Non-qualified deferred compensation share awards: Balance at inception/beginning of period - - Change in classification of deferred compensation share awards 192 - Share-based compensation expense 287 - Change in redemption value (80 ) - Vesting of share awards held by NDQC (127 ) - Ending Balance 272 - |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 USD ($) shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) PerformanceObligation Segment shares | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | ||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Gain (loss) on foreign currency transactions | $ 121,000 | $ 28,000 | ||||
Contract description | For revenues related to the BARDA contract within the scope of ASC 606, the Company identified two performance obligations: (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. | |||||
Cash at deposit institutions | $ 6,200,000 | $ 6,200,000 | $ 4,400,000 | |||
Cash in foreign institutions | 296,000 | 296,000 | 203,000 | |||
Cash equivalents held | 17,400,000 | 17,400,000 | 51,100,000 | |||
Restricted cash | $ 202,000 | $ 202,000 | $ 201,000 | |||
Concentration risk, customer | no | no | no | no | one | [1] |
Description of maturity terms | We classify all highly liquid investments with original maturities of three months or less from the date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months as marketable securities. The Company classifies marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date, and as long-term when the investments have remaining contractual maturities of more than one year from the balance sheet date | |||||
Final maturity period | 37 months | |||||
Lease renewal period | 3 years | 3 years | ||||
Contractual term | 10 years | |||||
Number of business segment | Segment | 1 | |||||
Number of shares awards deferred, unvested | shares | 253,048 | |||||
Redemption value of non-qualified deferred compensation share awards | $ 272,000 | |||||
Deferred compensation arrangement with individual, shares vested | shares | 17,927 | 17,927 | ||||
Deferred compensation arrangement with individual, vested value | $ 127,000 | |||||
Deferred Compensation Plans | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Employer matching contributions, Vesting period | 2 years | |||||
Vesting on Year One | Deferred Compensation Plans | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Employer matching contributions, Vesting percentage | 25% | |||||
Vesting on Year Two | Deferred Compensation Plans | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Employer matching contributions, Vesting percentage | 75% | |||||
Revenue Benchmark | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, customer | one | |||||
Minimum | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Revenue, performance obligation, description of payment terms | 30 days | |||||
Remaining lease terms | 1 year | 1 year | ||||
Maximum | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Revenue, performance obligation, description of payment terms | 90 days | |||||
Remaining lease terms | 2 years | 2 years | ||||
BARDA | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Contract description | For the contract with BARDA, the Company identified two performance obligations (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. | |||||
Number of performance obligations | PerformanceObligation | 2 | |||||
Commercial Customer | Accounts Receivable | Customer Concentration Risk | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 10% | 10% | 10% | 10% | 10% | |
BARDA | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Number of performance obligations | PerformanceObligation | 2 | |||||
Total transaction price of contract | $ 9,200,000 | |||||
RECELL system | BARDA | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Number of units will be delivered | 5,614 | |||||
Product replacement obligation cost | $ 0 | |||||
Deferred cost | $ 52,000 | $ 52,000 | $ 64,000 | |||
RECELL system | BARDA | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Number of units will be delivered | 5,614 | |||||
Transaction price allocated on a stand alone selling price basis | $ 7,600,000 | |||||
Emergency Deployment | BARDA | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Transaction price allocated on a stand alone selling price basis | $ 1,600,000 | |||||
Emergency Deployment Service | Commercial Customer | Revenue Benchmark | Customer Concentration Risk | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 1% | 1% | 1% | 30% | ||
Emergency Preparedness Services | BARDA | Accounts Receivable Revenue | Customer Concentration Risk | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Concentration risk, percentage | 2% | 3% | ||||
General and Administrative Expense | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Gain (loss) on foreign currency transactions | $ 6,000 | $ (14,000) | $ (2,000) | $ (30,000) | ||
General and Administrative Expense | Non-US | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Gain (loss) on foreign currency transactions | $ 76,000 | $ 41,000 | 123,000 | $ 58,000 | ||
Revenue | RECELL system | BARDA | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Transaction price allocated on a stand alone selling price basis | $ 1,600,000 | |||||
[1]one |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Other Receivables (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other Receivables Net Current [Abstract] | ||
BARDA procurement and emergency preparedness services | $ 15 | $ 9 |
BARDA expense reimbursements | 777 | 299 |
Total BARDA receivables | $ 792 | $ 308 |
Marketable Securities - Summary
Marketable Securities - Summary of Amortized Cost and Estimated Fair Values of Debt Securities Available for Sale (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost, Current marketable securities | $ 61,149 | $ 29,656 |
Gross Unrealized Holding Gains, Current marketable securities | 1 | |
Gross Unrealized Holding Losses, Current marketable securities | (591) | (7) |
Carrying Value, Current marketable securities | 60,559 | 29,649 |
Amortized Cost, Long-term marketable securities | 4,048 | 19,789 |
Gross Unrealized Holding Losses, Long-term marketable securities | (36) | (97) |
Carrying Value, Long-term marketable securities | 4,012 | 19,692 |
Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost, Current marketable securities | 3,317 | 7,068 |
Gross Unrealized Holding Losses, Current marketable securities | (33) | (7) |
Carrying Value, Current marketable securities | 3,284 | 7,061 |
Amortized Cost, Long-term marketable securities | 557 | 1,746 |
Gross Unrealized Holding Losses, Long-term marketable securities | (12) | (8) |
Carrying Value, Long-term marketable securities | 545 | 1,738 |
U.S Treasury Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost, Current marketable securities | 44,875 | |
Gross Unrealized Holding Gains, Current marketable securities | 1 | |
Gross Unrealized Holding Losses, Current marketable securities | (539) | |
Carrying Value, Current marketable securities | 44,337 | |
Amortized Cost, Long-term marketable securities | 2,887 | 18,043 |
Gross Unrealized Holding Losses, Long-term marketable securities | (21) | (89) |
Carrying Value, Long-term marketable securities | 2,866 | 17,954 |
Money Market Funds | Cash Equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 17,425 | 51,112 |
Carrying Value | 17,425 | 51,112 |
U.S Government Agency Obligations | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost, Current marketable securities | 1,902 | |
Gross Unrealized Holding Losses, Current marketable securities | (19) | |
Carrying Value, Current marketable securities | 1,883 | |
Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost, Current marketable securities | 11,055 | 19,586 |
Carrying Value, Current marketable securities | 11,055 | 19,586 |
Asset-backed Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost, Current marketable securities | 3,002 | |
Carrying Value, Current marketable securities | $ 3,002 | |
Amortized Cost, Long-term marketable securities | 604 | |
Gross Unrealized Holding Losses, Long-term marketable securities | (3) | |
Carrying Value, Long-term marketable securities | $ 601 |
Marketable Securities - Summa_2
Marketable Securities - Summary of Maturities of Debt Securities Available for Sale (Detail) - Contractual Maturities - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available for sale securities, Due in one year or less, Amortized cost | $ 61,149 | $ 29,656 |
Due after one year through three years | 4,048 | 19,789 |
Available for sale securities, Due in one year or less, Carrying value | 60,559 | 29,649 |
Due after one year through three years | $ 4,012 | $ 19,692 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Detail) - USD ($) | 6 Months Ended | 9 Months Ended |
Dec. 31, 2021 | Sep. 30, 2022 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Unrealized gain on marketable securities | $ 0 | $ 1,000 |
Unrealized loss on marketable securities | 104,000 | 627,000 |
Net unrealized loss on marketable securities | 104,000 | 626,000 |
Credit loss recognized | 0 | 0 |
Prepaids and Other Current Assets | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Accrued interest income | $ 72,000 | $ 146,000 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | $ 60,559 | $ 29,649 |
Total long-term marketable securities | 4,012 | 19,692 |
Fair Value on Recurring Basis | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 17,425 | 51,112 |
Total short-term marketable securities | 60,559 | 29,649 |
Total long-term marketable securities | 4,012 | 19,692 |
Total marketable securities and cash equivalents | 81,996 | 100,453 |
Fair Value on Recurring Basis | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 17,425 | 51,112 |
Total marketable securities and cash equivalents | 17,425 | 51,112 |
Fair Value on Recurring Basis | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 60,559 | 29,649 |
Total long-term marketable securities | 4,012 | 19,692 |
Total marketable securities and cash equivalents | 64,571 | 49,341 |
Fair Value on Recurring Basis | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 17,425 | 51,112 |
Fair Value on Recurring Basis | Money Market Funds | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 17,425 | 51,112 |
Fair Value on Recurring Basis | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 11,055 | 19,586 |
Fair Value on Recurring Basis | Commercial Paper | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 11,055 | 19,586 |
Fair Value on Recurring Basis | Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 3,284 | 7,061 |
Total long-term marketable securities | 545 | 1,738 |
Fair Value on Recurring Basis | Corporate Debt Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 3,284 | 7,061 |
Total long-term marketable securities | 545 | 1,738 |
Fair Value on Recurring Basis | U.S Government Agency Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 1,883 | |
Fair Value on Recurring Basis | U.S Government Agency Obligations | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 1,883 | |
Fair Value on Recurring Basis | U.S Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 44,337 | |
Total long-term marketable securities | 2,866 | 17,954 |
Fair Value on Recurring Basis | U.S Treasury Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 44,337 | |
Total long-term marketable securities | 2,866 | 17,954 |
Fair Value on Recurring Basis | Asset-backed Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | 3,002 | |
Total long-term marketable securities | 601 | |
Fair Value on Recurring Basis | Asset-backed Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term marketable securities | $ 3,002 | |
Total long-term marketable securities | $ 601 |
Leases - Additional Information
Leases - Additional Information (Detail) | Aug. 31, 2021 USD ($) |
Leases [Abstract] | |
Increase in operating lease ROU assets and operating lease liabilities | $ 392,000 |
Leases - Summary Of Lease Cost
Leases - Summary Of Lease Cost (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Lease Cost [Abstract] | ||||
Operating lease cost | $ 194 | $ 188 | $ 582 | $ 560 |
Variable lease cost | 13 | 12 | 38 | 36 |
Total lease cost | $ 207 | $ 200 | $ 620 | $ 596 |
Leases - Summary Of Supplementa
Leases - Summary Of Supplemental Cash Flow Information Related To Operating Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disclosure Of Supplemental Cash Flow Information Related To Operating Leases [Abstract] | ||||
Operating cash outflows from operating leases | $ 201 | $ 192 | $ 598 | $ 575 |
Leases - Summary Of Supplemen_2
Leases - Summary Of Supplemental Balance Sheet Information Related To Operating Leases (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Disclosure Of Supplemental Balance Sheet Information Related To Operating Leases [Abstract] | ||
Operating lease right-of-use assets | $ 1,029 | $ 1,544 |
Total right-of-use assets | 1,029 | 1,544 |
Operating lease liabilities, short-term | $ 702 | $ 720 |
Operating Lease Liability Current Statement Of Financial Position Extensible List | Other current liabilities | Other current liabilities |
Operating lease liabilities, long-term | $ 405 | $ 918 |
Total operating lease liabilities | $ 1,107 | $ 1,638 |
Operating lease weighted average remaining lease term (years) | 1 year 7 months 20 days | 2 years 3 months 18 days |
Operating lease weighted average discount rate | 6.64% | 6.51% |
Leases - Summary Of Maturities
Leases - Summary Of Maturities Of The Company's Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Operating Lease Liabilities Payments Due [Abstract] | ||
Remainder of 2022 | $ 205 | |
2023 | 649 | |
2024 | 314 | |
Total lease payments | 1,168 | |
Less imputed interest | (61) | |
Total operating lease liabilities | $ 1,107 | $ 1,638 |
Inventory - Summary Of Composit
Inventory - Summary Of Composition Of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,384 | $ 1,222 |
Work in process | 209 | 176 |
Finished goods | 367 | 734 |
Total inventory | $ 1,960 | $ 2,132 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Inventory Disclosure [Abstract] | ||||
Inventory impairments | $ 125,000 | $ 46,000 | $ 284,000 | $ 288,000 |
Intangible Assets - Summary Of
Intangible Assets - Summary Of Composition Of Intangible Assets (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Intangible Assets, Gross (Excluding Goodwill) | $ 729 | $ 673 |
Finite Lived Intangible Assets, Accumulated Amortization | (280) | (230) |
Finite Lived Intangible Assets, Net Carrying Amount | 399 | |
Intangible Assets, Net (Excluding Goodwill) | 449 | 443 |
Trademarks | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Indefinite-lived Intangible Assets (Excluding Goodwill) | $ 50 | 50 |
Patent 1 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 2 years | |
Finite Lived Intangible Assets, Gross Amount | $ 211 | 209 |
Finite Lived Intangible Assets, Accumulated Amortization | (210) | (182) |
Finite Lived Intangible Assets, Net Carrying Amount | $ 1 | 27 |
Patent 2 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 13 years | |
Finite Lived Intangible Assets, Gross Amount | $ 137 | 123 |
Finite Lived Intangible Assets, Accumulated Amortization | (25) | (18) |
Finite Lived Intangible Assets, Net Carrying Amount | $ 112 | 105 |
Patent 3 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 14 years | |
Finite Lived Intangible Assets, Gross Amount | $ 192 | 192 |
Finite Lived Intangible Assets, Accumulated Amortization | (37) | (25) |
Finite Lived Intangible Assets, Net Carrying Amount | $ 155 | 167 |
Patent 5 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 19 years | |
Finite Lived Intangible Assets, Gross Amount | $ 71 | 46 |
Finite Lived Intangible Assets, Accumulated Amortization | (5) | (3) |
Finite Lived Intangible Assets, Net Carrying Amount | $ 66 | 43 |
Patent 6 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 20 years | |
Finite Lived Intangible Assets, Gross Amount | $ 44 | 39 |
Finite Lived Intangible Assets, Accumulated Amortization | (3) | (2) |
Finite Lived Intangible Assets, Net Carrying Amount | $ 41 | 37 |
Patent 7 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 13 years | |
Finite Lived Intangible Assets, Gross Amount | $ 2 | 2 |
Finite Lived Intangible Assets, Net Carrying Amount | $ 2 | 2 |
Patent 8 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 19 years | |
Finite Lived Intangible Assets, Gross Amount | $ 13 | 3 |
Finite Lived Intangible Assets, Net Carrying Amount | $ 13 | 3 |
Patent 10 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 19 years | |
Finite Lived Intangible Assets, Gross Amount | $ 3 | 3 |
Finite Lived Intangible Assets, Net Carrying Amount | $ 3 | 3 |
Patent 11 | ||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 19 years | |
Finite Lived Intangible Assets, Gross Amount | $ 6 | 6 |
Finite Lived Intangible Assets, Net Carrying Amount | $ 6 | $ 6 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||||||
Impairment of intangible assets | $ 0 | $ 0 | ||||
Amortization of intangible assets | $ 8,000 | $ 27,000 | $ 50,000 | $ 88,000 | ||
Impairment charge | $ 19,000 | |||||
Abandoned Patent | ||||||
Schedule Of Intangible Assets Excluding Goodwill [Line Items] | ||||||
Impairment charge | $ 19,000 | $ 19,000 |
Intangible Assets - Summary o_2
Intangible Assets - Summary of Future Amortization of Amortizable Intangible assets held (Detail) $ in Thousands | Sep. 30, 2022 USD ($) |
Goodwill And Intangible Assets Disclosure [Abstract] | |
2023 | $ 33 |
2024 | 32 |
2025 | 32 |
2026 | 32 |
2027 | 32 |
Thereafter | 238 |
Finite Lived Intangible Assets, Net Carrying Amount | $ 399 |
Plant and Equipment - Summary O
Plant and Equipment - Summary Of Composition Of Property, Plant And Equipment (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Less: accumulated amortization and depreciation | $ (2,029) | $ (1,695) |
Total plant and equipment, net | $ 1,226 | 1,262 |
Computer Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Property, Plant and Equipment, Gross | $ 734 | 740 |
Computer Software | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Property, Plant and Equipment, Gross | $ 871 | 811 |
Construction In Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 181 | 29 |
Furniture And Fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 7 years | |
Property, Plant and Equipment, Gross | $ 440 | 440 |
Laboratory Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Property, Plant and Equipment, Gross | $ 643 | 566 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Useful Lives | Lesser of life or lease term | |
Property, Plant and Equipment, Gross | $ 257 | 242 |
RECELL Moulds | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Property, Plant and Equipment, Gross | $ 129 | $ 129 |
Plant and Equipment - Additiona
Plant and Equipment - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation | $ 130,000 | $ 147,000 | $ 388,000 | $ 429,000 |
Other Current and Long-Term A_3
Other Current and Long-Term Assets and Liabilities - Summary of Prepaids and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Prepaid expenses | $ 862 | $ 1,124 |
Lease deposits | 16 | 2 |
Accrued investment income | 146 | 72 |
Other receivables | 17 | 15 |
Total prepaids and other current assets | $ 1,041 | $ 1,213 |
Other Current and Long-Term A_4
Other Current and Long-Term Assets and Liabilities - Summary of Other Long Term Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other Assets Noncurrent Disclosure [Abstract] | ||
BARDA contract costs | $ 315 | $ 504 |
Long-term lease deposits | 121 | 124 |
Long-term prepaids | 112 | 10 |
Total other long-term assets | $ 548 | $ 638 |
Other Current and Long-Term A_5
Other Current and Long-Term Assets and Liabilities - Summary of Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other Liabilities Current [Abstract] | ||
Operating lease liability | $ 702 | $ 720 |
Unsettled investment trade payable | 480 | |
Other current liabilities | 437 | 355 |
Total other current liabilities | $ 1,619 | $ 1,075 |
Reporting Segment and Geograp_3
Reporting Segment and Geographic Information - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2022 Segment | |
Segment Reporting [Abstract] | |
Number of reporting segment | 1 |
Reporting Segment and Geograp_4
Reporting Segment and Geographic Information - Schedule Of Revenue and Cost Of Sales By Region and Customer Type (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue: | ||||
Revenues | $ 9,092 | $ 7,020 | $ 24,966 | $ 26,089 |
Cost of sales | ||||
Cost of sales | 1,530 | 1,088 | 4,694 | 5,287 |
BARDA deferred costs | (12) | 343 | ||
Commercial Sales | ||||
Revenue: | ||||
Revenues | 8,999 | 6,928 | 24,687 | 18,249 |
Product Sales | ||||
Revenue: | ||||
Revenues | 7,594 | |||
Services For Emergency Preparedness | ||||
Revenue: | ||||
Revenues | 93 | 92 | 279 | 246 |
Commercial Cost | ||||
Cost of sales | ||||
Cost of sales | 1,446 | 1,006 | 4,453 | 3,187 |
Product Cost | ||||
Cost of sales | ||||
BARDA deferred costs | (12) | 1,889 | ||
Emergency Preparedness Service Cost | ||||
Cost of sales | ||||
BARDA deferred costs | 84 | 82 | 253 | 211 |
United States | ||||
Revenue: | ||||
Revenues | 8,996 | 6,924 | 24,672 | 25,888 |
Foreign | Australia | ||||
Revenue: | ||||
Revenues | 57 | 66 | 173 | 141 |
Foreign | United Kingdom | ||||
Revenue: | ||||
Revenues | $ 39 | $ 30 | $ 121 | $ 60 |
Contingencies - Additional Info
Contingencies - Additional Information (Detail) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Threatened Litigation | ||
Litigation liability | $ 0 | $ 0 |
Common and Preferred Stock - Ad
Common and Preferred Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |||
Mar. 01, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Class Of Stock [Line Items] | ||||
Common stock shares authorized | 200,000,000 | 200,000,000 | ||
Common stock par value | $ 0.0001 | $ 0.0001 | ||
Preferred stock shares authorized | 10,000,000 | 10,000,000 | ||
Preferred stock par value | $ 0.0001 | $ 0.0001 | ||
Common stock shares issued | 25,030,902 | 24,925,743 | ||
Common stock shares outstanding | 25,030,902 | 24,925,743 | ||
Preferred stock shares outstanding | 0 | 0 | ||
Stock issued during period, value, new issues | $ 69,106 | |||
Common Stock | ||||
Class Of Stock [Line Items] | ||||
Stock issued during period, shares, new issues | 3,214,250 | 3,214,250 | ||
Sale of stock issue price per share | $ 21.50 | |||
Stock issued during period, value, new issues | $ 69,100 | |||
Capital issuance expenses | $ 5,100 | |||
Shareholders Of Avita Medical | ADRS | ||||
Class Of Stock [Line Items] | ||||
Reverse stock split ratio, description | One share of common stock on NASDAQ is equivalent to five CDIs on the ASX. |
Revenues - Additional Informati
Revenues - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) PerformanceObligation | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||||
Contract description | For revenues related to the BARDA contract within the scope of ASC 606, the Company identified two performance obligations: (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. | ||||
Capitalized fulfilment costs | $ 315,000 | $ 315,000 | $ 504,000 | ||
Performance obligation estimated revenue expected to be recognized | 740,000 | 740,000 | 952,000 | ||
Contract with customer assets | 0 | 0 | 0 | ||
Contract with customers non current liability | 740,000 | 740,000 | 952,000 | ||
Contract cost amortization | 253,000 | $ 211,000 | |||
Contract cost impairment loss | 0 | $ 0 | 0 | 0 | |
Cost of Sales | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||||
Contract cost amortization | 84,000 | 82,000 | 253,000 | 211,000 | |
Other Noncurrent Assets | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||||
Capitalized fulfilment costs | 315,000 | $ 315,000 | 504,000 | ||
BARDA | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||||
Contract description | For the contract with BARDA, the Company identified two performance obligations (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. | ||||
Number of performance obligations | PerformanceObligation | 2 | ||||
Contract with customer liability revenue recognized | 93,000 | 92,000 | $ 279,000 | 246,000 | |
BARDA | RECELL system | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||||
Number of units will be delivered | 5,614 | ||||
Product replacement obligation cost | $ 0 | ||||
Deferred cost | 52,000 | 52,000 | 64,000 | ||
Services recognized | 93,000 | 92,000 | 279,000 | 246,000 | |
Performance obligation estimated revenue expected to be recognized | 308,000 | 308,000 | 517,000 | ||
Japanese Pharmaceuticals and Medical Device Act Approval | RECELL system | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||||
Performance obligation estimated revenue expected to be recognized | 432,000 | 432,000 | $ 435,000 | ||
COSMOTEC | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||||
Contract with customer liability revenue recognized | $ 3,000 | $ 0 | $ 3,000 | $ 0 |
Share-Based Payment Plans - Add
Share-Based Payment Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 01, 2022 | Dec. 22, 2021 | Sep. 30, 2022 | Nov. 30, 2019 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Oct. 14, 2021 | Nov. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation | $ 1,400 | $ 1,800 | $ 5,800 | $ 4,600 | |||||||
Income tax benefit (expense) | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period | 334,450 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested | 105,034 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 461,496 | 461,496 | 461,496 | 297,490 | |||||||
Milestone performance awards to CEO | 2,132,195 | 2,132,195 | 2,132,195 | 1,756,720 | |||||||
Restricted Stock Units (RSUs) | Patient Visit For Treatment And Regulatory Approval | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 0 | 0 | 0 | ||||||||
Performance Based Share Options | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 593,094 | 593,094 | 593,094 | 599,994 | |||||||
Non Option Performance Based Restricted Stock Units | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested | 57,527 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 65,646 | 65,646 | 65,646 | 135,093 | |||||||
Market Awards | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 27,600 | ||||||||||
Non Option Market Condition | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 47,640 | ||||||||||
2020 Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement contractual term of awards | 10 years | ||||||||||
Share based compensation by share based payment arrangement vesting period | 4 years | ||||||||||
2020 Plan | Vesting Period One | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting percentage | 25% | ||||||||||
2020 Plan | Vesting Period Two | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting percentage | 25% | ||||||||||
2020 Plan | Vesting Period Three | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting percentage | 25% | ||||||||||
2020 Plan | Vesting Period Four | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting percentage | 25% | ||||||||||
2020 Plan | Common Stock [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement number of shares authorised for issuance | 1,750,000 | ||||||||||
Employee Share Plan And Incentive Option Plan Two Thousand And Sixteen | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Reverse stock split | reverse stock split of 100:1 | ||||||||||
Employee Share Plan And Incentive Option Plan Two Thousand And Sixteen | Restricted Stock Units (RSUs) | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement contractual term of awards | 10 years | ||||||||||
Long Term Incentive Plan | Restricted Stock Units (RSUs) | Chief Executive Officer | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period | 395,542 | ||||||||||
Long Term Incentive Plan | Restricted Stock Units (RSUs) | Chief Executive Officer | Service Based Milestone | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting period | 3 years | ||||||||||
Tenure RSU awards to CEO | 142,521 | 142,521 | 142,521 | ||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested | 47,507 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 0 | 0 | 0 | ||||||||
Long Term Incentive Plan | Restricted Stock Units (RSUs) | Chief Executive Officer | Patient Visit For Treatment And Regulatory Approval | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO on Nov 2019 | 253,021 | 253,021 | 253,021 | ||||||||
2021 AGM Awards | Chief Executive Officer | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting percentage | 25% | ||||||||||
Aggregate number of options and RSU | 150,480 | ||||||||||
Tenure awards to CEO | 37,600 | ||||||||||
Tenure option awards to CEO | 13,800 | ||||||||||
2021 AGM Awards | Restricted Stock Units (RSUs) | Chief Executive Officer | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Tenure RSU awards to CEO | 23,800 | ||||||||||
2021 AGM Awards | Performance Based Share Options | Chief Executive Officer | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 37,640 | ||||||||||
Milestone performance awards to CEO | 13,800 | ||||||||||
2021 AGM Awards | Performance Based Share Options | Chief Executive Officer | Share-Based Payment Arrangement, Tranche One | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 9,410 | ||||||||||
Milestone performance awards to CEO | 3,450 | ||||||||||
Milestone performance awards to CEO, vested | 3,450 | ||||||||||
Description of the milestone to be achieved for vesting of restricted stock awards | 9,410 awards (5,960 RSUs and 3,450 options) - Achieve Centers for Medicare and Medicaid Services reimbursement for out-patient transitional pass-through payment code (“TPT”) by June30, 2022. This performance condition was met during the quarter ended March 31, 2022 resulting in the 5,960 RSUs vesting and 5,960 shares of common stock being issued in respect of those vested RSUs, as well as the 3,450 options vesting (although those vested options have not been exercised by the Former CEO as at the date of this Form 10-Q). | ||||||||||
2021 AGM Awards | Performance Based Share Options | Chief Executive Officer | Share-Based Payment Arrangement, Tranche Two | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 9,410 | ||||||||||
Milestone performance awards to CEO | 3,450 | ||||||||||
Description of the milestone to be achieved for vesting of restricted stock awards | 9,410 awards (5,960 RSUs and 3,450 options) - Achieve Japanese approval from Pharmaceuticals and Medical Device Agency (“PMDA”) and reimbursement code by September 30, 2022. This performance condition was met during the quarter ended September 30, 2022, resulting in the RSUs vesting and 5,960 shares of common stock being issued in respect of those vested RSUs, as well as the 3,450 options vesting (although those vested options have not been exercised by the Former CEO as at the date of this Form 10-Q). | ||||||||||
2021 AGM Awards | Performance Based Share Options | Chief Executive Officer | Share-Based Payment Arrangement, Tranche Three | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 9,410 | ||||||||||
Milestone performance awards to CEO | 3,450 | ||||||||||
Description of the milestone to be achieved for vesting of restricted stock awards | 9,410 awards (5,960 RSUs and 3,450 options) - Achieve profitability of the Company’s Burns business for two consecutive quarters by March 31, 2023. These awards were unvested as at the date of termination of the Former CEO's employment. | ||||||||||
2021 AGM Awards | Performance Based Share Options | Chief Executive Officer | Share Based Compensation Award Tranche Four | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 9,410 | ||||||||||
Milestone performance awards to CEO | 3,450 | ||||||||||
Description of the milestone to be achieved for vesting of restricted stock awards | 9,410 awards (5,960 RSUs and 3,450 options) - Achieve US FDA approval of vitiligo indication by December 31, 2023. These awards were unvested as at the date of termination of the Former CEO's employment. | ||||||||||
2021 AGM Awards | Non Option Performance Based Restricted Stock Units | Chief Executive Officer | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 23,840 | ||||||||||
2021 AGM Awards | Non Option Performance Based Restricted Stock Units | Chief Executive Officer | Share-Based Payment Arrangement, Tranche One | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested | 5,960 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 5,960 | ||||||||||
2021 AGM Awards | Non Option Performance Based Restricted Stock Units | Chief Executive Officer | Share-Based Payment Arrangement, Tranche Two | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 5,960 | ||||||||||
2021 AGM Awards | Non Option Performance Based Restricted Stock Units | Chief Executive Officer | Share-Based Payment Arrangement, Tranche Three | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 5,960 | ||||||||||
2021 AGM Awards | Non Option Performance Based Restricted Stock Units | Chief Executive Officer | Share Based Compensation Award Tranche Four | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 5,960 | ||||||||||
2021 AGM Awards | Market Awards | Chief Executive Officer | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 75,240 | ||||||||||
Milestone performance awards to CEO | 27,600 | ||||||||||
2021 AGM Awards | Market Awards | Chief Executive Officer | Share-Based Payment Arrangement, Tranche One | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 37,620 | ||||||||||
Milestone performance awards to CEO | 13,800 | ||||||||||
Description of the milestone to be achieved for vesting of restricted stock awards | 37,620 (23,820 RSUs and 13,800 options) - Achieve a doubling based on a 10-day volume-weighted average price (“VWAP”) of the Company’s share price as of the date of the 2021 Annual Meeting (being December 14, 2021) by September 30, 2023. The target share price is $25.74. These awards were unvested as at the date of termination of the Former CEO's employment. | ||||||||||
Targeted share Price | $ 25.74 | ||||||||||
2021 AGM Awards | Market Awards | Chief Executive Officer | Share-Based Payment Arrangement, Tranche Two | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Milestone performance awards to CEO | 37,620 | ||||||||||
Milestone performance awards to CEO | 13,800 | ||||||||||
Description of the milestone to be achieved for vesting of restricted stock awards | 37,620 (23,820 RSUs and 13,800 options) - Achieve a market capitalization of the Company of greater than or equal to US$1.25 billion (as compared to market capitalization of ~US$435M as of October 14, 2021) and maintain that market capitalization for at least 30 consecutive calendar days on or before December 31, 2024. | ||||||||||
Market capitalization | $ 1,250,000 | $ 435,000 | |||||||||
2021 AGM Awards | Non Option Market Condition | Chief Executive Officer | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 47,640 | ||||||||||
2021 AGM Awards | Non Option Market Condition | Chief Executive Officer | Share-Based Payment Arrangement, Tranche One | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 23,820 | ||||||||||
2021 AGM Awards | Non Option Market Condition | Chief Executive Officer | Share-Based Payment Arrangement, Tranche Two | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options outstanding number | 23,820 | ||||||||||
Two Thousand And Twenty One A G M Plan | Board of Director | Service Period Milestone | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting period | 12 months | ||||||||||
Aggregate number of options and RSU | 68,600 | ||||||||||
Tenure awards to Board of Director | 41,400 | ||||||||||
Tenure option awards to Board of Director | 15,300 | ||||||||||
Tenure awards granted to Board of Director | 6,900 | ||||||||||
Tenure option awards granted to Board of Director | 2,550 | ||||||||||
Two Thousand And Twenty One A G M Plan | Board of Director | Vesting Percentage Milestone | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Share based compensation by share based payment arrangement vesting percentage | 33.33% | ||||||||||
Tenure awards to Board of Director | 27,200 | ||||||||||
Tenure option awards to Board of Director | 9,850 | ||||||||||
Tenure awards granted to Board of Director | 13,600 | ||||||||||
Tenure option awards granted to Board of Director | 4,925 | ||||||||||
Two Thousand And Twenty One A G M Plan | Restricted Stock Units (RSUs) | Board of Director | Service Period Milestone | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Tenure RSU awards to Board of Director | 26,100 | ||||||||||
Tenure RSU awards granted to Board of Director | 4,350 | ||||||||||
Two Thousand And Twenty One A G M Plan | Restricted Stock Units (RSUs) | Board of Director | Vesting Percentage Milestone | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Tenure RSU awards to Board of Director | 17,350 | ||||||||||
Tenure RSU awards granted to Board of Director | 8,675 |
Share-Based Payment Plans - Sum
Share-Based Payment Plans - Summary Of Stock-based Compensation Is Reflected In The Statements Of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based Payment Arrangement, Expense | $ 1,436 | $ 1,842 | $ 5,782 | $ 4,585 |
Selling and Marketing Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based Payment Arrangement, Expense | 408 | 291 | 1,022 | 592 |
General and Administrative Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based Payment Arrangement, Expense | 761 | 1,251 | 4,071 | 3,353 |
Research and Development Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Share-based Payment Arrangement, Expense | $ 267 | $ 300 | $ 689 | $ 640 |
Share-Based Payment Plans - S_2
Share-Based Payment Plans - Summary Of Share Option Activity (Detail) | 9 Months Ended |
Sep. 30, 2022 shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Beginning balance | 1,756,720 |
Granted | 456,300 |
Exercised | (125) |
Expired | (39,525) |
Forfeited | (41,175) |
Ending balance | 2,132,195 |
Exercisable | 1,032,395 |
Service Only Share Options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Beginning balance | 1,129,126 |
Granted | 456,300 |
Exercised | (125) |
Expired | (5,025) |
Forfeited | (41,175) |
Ending balance | 1,539,101 |
Exercisable | 668,137 |
Performance Based Share Options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Beginning balance | 599,994 |
Expired | (6,900) |
Ending balance | 593,094 |
Exercisable | 364,258 |
Market Awards | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Beginning balance | 27,600 |
Expired | (27,600) |
Share-Based Payment Plans - S_3
Share-Based Payment Plans - Summary Of Company Unvested RSUs (Detail) | 9 Months Ended |
Sep. 30, 2022 shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unvested RSUs beginning balance | 297,490 |
Unvested RSUs granted | 334,450 |
Unvested RSUs vested | (105,034) |
Unvested RSUs forfeited | (65,410) |
Unvested RSUs ending balance | 461,496 |
Non Options Service Based Restricted Stock Units | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unvested RSUs beginning balance | 114,757 |
Unvested RSUs granted | 334,450 |
Unvested RSUs vested | (47,507) |
Unvested RSUs forfeited | (5,850) |
Unvested RSUs ending balance | 395,850 |
Non Option Performance Based Restricted Stock Units | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unvested RSUs beginning balance | 135,093 |
Unvested RSUs vested | (57,527) |
Unvested RSUs forfeited | (11,920) |
Unvested RSUs ending balance | 65,646 |
Non Option Market Condition | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unvested RSUs beginning balance | 47,640 |
Unvested RSUs forfeited | (47,640) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | |||||||||
Tax expense | $ 4,000 | $ 6,000 | $ 12,000 | $ 23,000 | |||||
Deferred tax assets valuation allowance | $ 51,300,000 | $ 46,900,000 | |||||||
Unrecognized income tax benefits | $ 0 | 0 | $ 0 | ||||||
Tax Cut And Jobs Act | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Percentage of tax amount likely to be realised | 50% | 50% | 50% | ||||||
Tax Year 2026 through 2038 | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Net operating loss carryforwards | $ 21,700,000 | ||||||||
Earliest Tax Year | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Open tax year | 2026 | ||||||||
Latest Tax Year | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Open tax year | 2038 | ||||||||
Internal Revenue Service (IRS) | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Net operating loss carryforwards | $ 122,000,000 | ||||||||
State and Local Jurisdiction | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Net operating loss carryforwards | $ 79,700,000 | ||||||||
State and Local Jurisdiction | Earliest Tax Year | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Open tax year | 2026 | ||||||||
State and Local Jurisdiction | Latest Tax Year | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Open tax year | 2041 | ||||||||
Her Majesty's Revenue and Customs (HMRC) | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Net operating loss carryforwards | $ 31,900,000 | ||||||||
Australian Taxation Office | |||||||||
Income Tax Disclosure [Line Items] | |||||||||
Net operating loss carryforwards | $ 38,200,000 |
Net Loss per Share - Summary of
Net Loss per Share - Summary of Reconciliation of The Basic And Diluted Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net Loss | $ (5,588) | $ (5,948) | $ (21,312) | $ (16,663) |
Weighted-average common shares – outstanding, basic | 25,006,995 | 24,905,403 | 24,972,331 | 24,174,811 |
Weighted-average common shares – outstanding, diluted | 25,006,995 | 24,905,403 | 24,972,331 | 24,174,811 |
Net loss per common share, basic | $ (0.22) | $ (0.24) | $ (0.85) | $ (0.69) |
Net loss per common share, diluted | $ (0.22) | $ (0.24) | $ (0.85) | $ (0.69) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2022 shares | |
Earnings Per Share [Abstract] | |
Common stock excluded from calculation of basic and diluted EPS | 17,927 |
Retirement Plans - Additional I
Retirement Plans - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | |||||
Defined contribution plan employers matching contribution percentage of employees pay | 6% | ||||
Employers contribution to retirement plan | $ 312,000 | $ 183,000 | $ 783,000 | $ 606,000 | |
Number of shares awards deferred, unvested | 253,048 | ||||
Deferred compensation arrangement with individual, shares vested | 17,927 | 17,927 | |||
Deferred compensation arrangement with individual, vested redemption value | $ 127,000 | ||||
Non-qualified Deferred Compensation Plans | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Employer matching contributions, Vesting period | 2 years | ||||
Employer contributions to deferred compensation plan | $ 75,000 | $ 0 | $ 197,000 | $ 0 | |
Deferred compensation plan liability | $ 1,000,000 | $ 1,000,000 | $ 262,000 | ||
Non-qualified Deferred Compensation Plans | Vesting on Year One | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Employer matching contributions, Vesting percentage | 25% | ||||
Non-qualified Deferred Compensation Plans | Vesting on Year Two | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Employer matching contributions, Vesting percentage | 75% | ||||
Non-qualified Deferred Compensation Plans | Minimum | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Defined contribution plan employers matching contribution percentage of employees pay | 4% | ||||
Non-qualified Deferred Compensation Plans | Maximum | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Defined contribution plan employers matching contribution percentage of employees pay | 6% |
Retirement Plans - Summary of F
Retirement Plans - Summary of Fair Values of Company's Deferred Compensation Plan Assets and Liability (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Non-qualified deferred compensation plan liability | $ 1,016 | $ 262 | |
Non-qualified Deferred Compensation Plans | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Corporate-owned life insurance policies | [1] | 948 | 304 |
Non-qualified deferred compensation plan liability | [2] | 1,016 | 262 |
Non-qualified Deferred Compensation Plans | Level 2 | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Corporate-owned life insurance policies | [1] | 948 | 304 |
Non-qualified deferred compensation plan liability | [2] | $ 1,016 | $ 262 |
[1] (1) (2) |
Retirement Plans - Summary of E
Retirement Plans - Summary of Eligible Share Award Activity (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Change in classification of deferred compensation share awards | $ (192) | |
Share-based compensation | 5,782 | $ 4,585 |
Non-qualified | Deferred Compensation Plans | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Change in classification of deferred compensation share awards | 192 | |
Share-based compensation | 287 | |
Change in redemption value | (80) | |
Vesting of share awards held by NDQC | (127) | |
Ending Balance | $ 272 |