Financial Performance - Revenues for the three months ended September 30, 2023, were $13,645,000, a 50.1% increase from $9,092,000 in the same period of 2022[16] - Gross profit for the nine months ended September 30, 2023, was $29,964,000, compared to $20,272,000 for the same period in 2022, reflecting a 47.9% increase[16] - Operating loss for the three months ended September 30, 2023, was $9,306,000, compared to a loss of $5,748,000 in the same period of 2022, indicating a 62.5% increase in losses[16] - Net loss for the nine months ended September 30, 2023, was $28,316,000, compared to $21,312,000 for the same period in 2022, representing a 33% increase in net losses[16] - Net loss for the nine months ended September 30, 2023, was $28.316 million, compared to a net loss of $21.312 million for the same period in 2022, representing a 33.9% increase in losses[27] - The net loss for the three months ended September 30, 2023, was $8.712 million, compared to a net loss of $5.588 million for the same period in 2022, representing a 56.5% increase in losses[84] - The basic and diluted net loss per share for the three months ended September 30, 2023, was $0.34, up from $0.22 in the same period of 2022, indicating a 54.5% increase[84] Assets and Liabilities - Total current assets decreased to $73,927,000 as of September 30, 2023, from $87,458,000 as of December 31, 2022, a decline of 15.4%[14] - Total liabilities increased to $17,407,000 as of September 30, 2023, compared to $12,967,000 as of December 31, 2022, reflecting a 34.5% increase[14] - Stockholders' equity decreased to $62,978,000 as of September 30, 2023, from $84,740,000 as of December 31, 2022, a decline of 25.7%[14] - Cash and cash equivalents rose to $50,854,000 as of September 30, 2023, up from $18,164,000 as of December 31, 2022, a significant increase of 179.5%[14] - Cash used in operations for the nine months ended September 30, 2023, was $27.148 million, up from $15.654 million in the prior year, indicating a 73.5% increase in cash outflow[27] - As of September 30, 2023, cash and cash equivalents amounted to $4.4 million, with cash equivalents primarily in money market funds totaling $46.4 million[46] - Total current marketable securities as of September 30, 2023, were valued at $9.3 million, with U.S. Treasury securities contributing $5.4 million[51] - The Company reported a net unrealized loss of $20,000 on marketable securities as of September 30, 2023, compared to a net unrealized loss of $426,000 as of December 31, 2022[53] - The Company has accrued interest income of $228,000 as of September 30, 2023, compared to $168,000 as of December 31, 2022[53] Revenue Sources - The company reported BARDA income of $212,000 for the three months ended September 30, 2023, down from $904,000 in the same period of 2022, a decrease of 76.5%[16] - The Company recognized $90,000 and $250,000 in revenue from BARDA for the three-months and nine-months ended September 30, 2023, respectively, compared to $93,000 and $279,000 for the same periods in 2022[62] - Estimated revenue from remaining performance obligations is $469,000 as of September 30, 2023, down from $698,000 as of December 31, 2022, with a notable portion related to the BARDA contract[59] Research and Development - Research and development expenses for the nine months ended September 30, 2023, were $14,056,000, compared to $10,478,000 for the same period in 2022, an increase of 34.7%[16] Stock and Compensation - Total stock-based compensation for the nine months ended September 30, 2023, was $6.213 million, compared to $5.782 million in the prior year, marking a 7.5% increase[27] - Stock-based compensation expense for the three-months ended September 30, 2023, was $2.4 million, compared to $1.4 million in 2022, a 71.4% increase[78] - The Company’s total common stock increased to 25,550,694 shares by September 30, 2023, from 25,030,902 shares a year earlier, reflecting a growth of 2.1%[24] - The Company had a payout of approximately $753,000 in the deferred compensation liability for terminated employees during the third quarter of 2023[87] Operational Changes - The Company received FDA approval for the RECELL System for full-thickness skin defects on June 7, 2023, and commenced commercial launch on June 8, 2023[30] - The FDA approved a PMA application for the repigmentation of stable depigmented vitiligo lesions on June 16, 2023, with a post-market study expected to be completed by the end of 2024[31] - The company submitted a PMA supplement for RECELL GO™ on June 29, 2023, with a complete response to the FDA expected by February 28, 2024, potentially leading to a product launch on May 31, 2024[32] Inventory and Assets Management - Total inventory increased to $4,377,000 as of September 30, 2023, compared to $2,125,000 as of December 31, 2022, reflecting growth in raw materials, work in process, and finished goods[67] - The Company recorded charges for estimated excess and obsolescence in inventory of $81,000 for the three-months ended September 30, 2023, compared to $125,000 for the same period in 2022[67] - Total plant and equipment, net increased to $1,862,000 as of September 30, 2023, from $1,200,000 as of December 31, 2022, representing a 55.0% increase[70] - Depreciation expense for the three-months ended September 30, 2023, was $156,000, up from $130,000 for the same period in 2022, a 20.0% increase[70] Lease and Other Liabilities - Operating lease liabilities increased to $2,749,000 as of September 30, 2023, from $918,000 as of December 31, 2022, due to new lease agreements[66] - Other current liabilities increased to $1,341,000 as of September 30, 2023, from $990,000 as of December 31, 2022, a 35.4% increase[73] Future Financial Planning - The Company entered into a Credit Agreement on October 18, 2023, providing a five-year senior secured credit facility of up to $90 million, with an initial borrowing of $40 million[95] - The Company issued a warrant to purchase up to 409,661 shares of common stock at an exercise price of $10.9847 per share as part of the Credit Agreement[96] - The Company expects future amortization expenses for intangible assets to total $405,000, with $9,000 expected for the remainder of 2023[69]

Financial Data and Key Metrics Changes - The company reported commercial revenues of $11.7 million for Q2 2023, representing a 42% increase compared to $8.2 million in the same period in 2022, and at the top end of the guidance range of $10.7 million to $11.7 million [26][60] - The gross profit margin was 81%, down from 83% in the same period in 2022, primarily due to decreased product production in one month of the quarter [39] - The net loss for the quarter was $10.4 million, or a loss of $0.41 per share, compared to a net loss of $6.3 million, or a loss of $0.25 per share in the same period in 2022 [63] Business Line Data and Key Metrics Changes - The increase in commercial revenue was largely driven by broader surgeon usage and deeper penetration, particularly within smaller burn procedures [52] - The company achieved two landmark FDA approvals and a pivotal FDA submission, which are critical for advancing its platform and unlocking growth potential [25] Market Data and Key Metrics Changes - The expansion into trauma centers allows the commercial team to capture a larger portion of the burn market, with an initial target market of approximately 127,000 eligible soft tissue repair procedures and 35,000 eligible burn procedures, representing a total addressable market (TAM) of over $1.2 billion [43] - Japan represents a majority of the foreign revenue line item, with over 90% of international revenue coming from this market [102] Company Strategy and Development Direction - The company is expanding its focus from burn centers to include hospitals, trauma centers, and outpatient settings, with plans to build out its portfolio and explore external business development opportunities [20] - The company is increasing its 2023 annual revenue guidance from $49 million to $51 million, now expecting a range of $51 million to $53 million, reflecting a 53% growth over 2022 at the midpoint of guidance [37][64] Management's Comments on Operating Environment and Future Outlook - Management expressed bullishness about the remainder of the year and 2024, citing early momentum and preparation for new approvals [13] - The company plans to provide 2024 guidance in February 2024, indicating a solid balance sheet and ongoing development of its 2024 plan [51][77] Other Important Information - The company initiated the expansion of its commercial organization, more than doubling its team from 30 to 70, which will result in peak operating expenses as a percentage of revenue in Q3 2023 [47] - The RECELL GO product is expected to significantly ease the burden of training required for physicians and operating room staff, leading to increased adoption across indications [80] Q&A Session Summary Question: Can you provide insight on the broader label secured for soft-tissue data and the potential rethinking of the commercial organization structure? - Management indicated that there are numerous applications under full-thickness skin defects that create a much bigger opportunity, and they plan to assess these before rushing into new initiatives [56] Question: What is the expected timeline for new sales reps to reach productivity levels? - It was noted that new sales reps typically take three to six months to reach cost coverage, with five resale kits per month needed to break even [101] Question: How does the company view margins longer term with the introduction of RECELL GO? - Management expects margins to increase as sales volume grows, potentially approaching 90% margins if sales align with expectations [106] Question: What specific cases are doctors most comfortable with regarding the new indication for full-thickness skin defects? - Management mentioned that cases like degloving and necrotizing fasciitis are being captured quickly, indicating a positive early adoption trend [107]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organizat ...

AVITA Medical, Inc. (NASDAQ:RCEL) Q1 2023 Results Conference Call May 11, 2023 4:30 PM ET Company Participants Jessica Ekeberg - Investor Relations James Corbett - Chief Executive Officer Sean Ekins - Acting Chief Financial Officer Conference Call Participants Joshua Jennings - TD Cowen Phillip Dantoin - Piper Sandler Ryan Zimmerman - BTIG Operator Good day and thank you for standing by. Welcome to the AVITA Medical Inc. First Quarter 2023 Earnings Conference Call. At this time all participants are in a lis ...

Financial Performance - Revenues for the three months ended March 31, 2023, were $10,550,000, representing a 40.0% increase from $7,539,000 in the same period of 2022[16] - Gross profit for the same period was $8,883,000, up from $5,761,000, indicating a gross margin improvement[16] - The net loss for the three months ended March 31, 2023, was $9,220,000, slightly improved from a net loss of $9,463,000 in the prior year[19] - Net loss for the three months ended March 31, 2023, was $9.22 million, a slight improvement from a net loss of $9.46 million in the same period of 2022[24] - Total revenue for the three months ended March 31, 2023, was $10,550,000, representing a 40.4% increase from $7,539,000 in the same period of 2022[103] - Revenue from the United States was $9,425,000, up 27.4% from $7,398,000 year-over-year[103] - Commercial sales accounted for $10,458,000 of total revenue, an increase of 40.4% from $7,446,000 in the prior year[103] Expenses and Liabilities - Total operating expenses increased to $19,421,000 from $15,982,000, primarily driven by higher sales and marketing expenses of $6,540,000 compared to $4,828,000[16] - Stock-based compensation expense for the three months ended March 31, 2023, was $2,640,000, a decrease from $2,932,000 in the same period of 2022[111] - Total liabilities rose to $14,268,000 from $12,967,000, with current liabilities increasing to $11,486,000[14] - The Company’s deferred compensation plan liability increased to $3.3 million as of March 31, 2023, compared to $1.3 million as of December 31, 2022[125] Cash and Cash Equivalents - Cash and cash equivalents increased to $28,050,000 as of March 31, 2023, compared to $18,164,000 at December 31, 2022[14] - Cash flow from operating activities resulted in a net cash used of $9.07 million, compared to $9.37 million in the prior year, indicating a reduction in cash burn[24] - Cash provided by investing activities was $18.79 million, a significant increase from a cash used of $22.60 million in the same period last year, primarily due to maturities of marketable securities[24] - Cash and cash equivalents at the end of the period increased to $28.05 million from $23.74 million at the end of the previous year[24] - The company's cash equivalents, specifically money market funds, increased from $14,089,000 as of December 31, 2022, to $24,797,000 as of March 31, 2023[75] Assets and Marketable Securities - Total assets decreased to $92,622,000 from $98,264,000, reflecting a reduction in marketable securities[14] - The Company’s marketable securities, classified as available-for-sale, include corporate debt securities and U.S. government obligations, and are carried at fair value[52] - As of March 31, 2023, the total current marketable securities amounted to $45,401,000, with a gross unrealized loss of $188,000[73] - The total long-term marketable securities as of March 31, 2023, were valued at $4,189,000, with a gross unrealized loss of $5,000[73] - The net unrealized loss on marketable securities as of March 31, 2023, was $185,000, compared to a net unrealized loss of $426,000 as of December 31, 2022[75] Customer and Revenue Recognition - The company recognized revenue from the sale of the RECELL System to BARDA when the product is placed in the vendor-managed inventory, reflecting a shift in revenue recognition practices[41] - BARDA revenue for emergency deployment accounted for approximately 1% of total revenues for the three months ended March 31, 2023, consistent with the previous year[49] - As of March 31, 2023, no single commercial customer accounted for more than 10% of net accounts receivable, indicating a diversified customer base[49] Research and Development - The Company’s BARDA grant supports ongoing research and development, including clinical trials for soft-tissue reconstruction, with income recognized under a cost-plus-fixed-fee arrangement[55][56] - The company plans to submit a PMA supplement application for the RECELL GO device by June 30, 2023, maintaining its FDA Breakthrough Device designation[26] - The RECELL System has received FDA approval for expanded use in treating acute full-thickness thermal wounds in both pediatric and adult patients[26] - COSMOTEC launched the RECELL System in Japan in September 2022, following regulatory approval, and is evaluating further applications for additional indications[27] Tax and Deferred Compensation - The company recorded a tax expense of $30,000 for the three months ended March 31, 2023, compared to $4,000 in the same period of 2022[118] - As of March 31, 2023, the company had net operating loss carryforwards totaling $129.5 million for federal tax purposes[118] - The company has established a valuation allowance against its net deferred tax assets of $56.5 million as of December 31, 2022[119] - The company did not identify any uncertain tax positions as of March 31, 2023[121] Inventory and Amortization - Total inventory increased to $2,811,000 as of March 31, 2023, from $2,125,000 as of December 31, 2022[95] - Amortization expense related to intangible assets was $9,000 for the three months ended March 31, 2023, compared to $34,000 for the same period in 2022[97] - The Company expects future amortization of amortizable intangible assets to total $407,000[98] Other Financial Information - The Company recorded a foreign currency transaction gain of $11,000 for the three months ended March 31, 2023, compared to a loss of $22,000 in the same period of 2022[33] - The Company entered into a Sales Agreement on April 14, 2023, to offer and sell up to 3,799,164 shares of its common stock, with no sales made under the agreement as of the report date[132] - The Company executed a new office lease in Irvine, California, for a term of 60 months with an average monthly rent of approximately $25,000[133]

AVITA Medical, Inc. (NASDAQ:RCEL) Q4 2022 Earnings Conference Call February 23, 2023 4:30 PM ET Company Participants Caroline Corner - Managing Director, Investor Relations Jim Corbett - Chief Executive Officer Sean Ekins - Acting Chief Financial Officer Conference Call Participants Joshua Jennings - Cowen Phillip Dantoin - Piper Brooks O'Neil - Lake Street Capital Markets Lyanne Harrison - Bank of America Operator Good day and thank you for standing by. Welcome to AVITA Medical Fourth Quarter 2022 Earnings ...

Part I [Business](index=4&type=section&id=Item%201.%20BUSINESS) AVITA Medical is a regenerative medicine company focused on skin restoration through its proprietary RECELL® System - AVITA Medical is a regenerative medicine company commercializing the RECELL® System, a technology that creates an autologous skin cell suspension (Spray-On Skin™ Cells) to regenerate skin[17](index=17&type=chunk) - The company's core strategy includes increasing penetration in the U.S. burns market, commercializing RECELL for soft tissue repair and vitiligo following anticipated FDA approvals, and expanding internationally, particularly in Japan[30](index=30&type=chunk) - In December 2022, the company submitted a Premarket Approval (PMA) supplement application to the FDA for the use of RECELL in soft tissue repair and a separate PMA application for its use in treating vitiligo[51](index=51&type=chunk)[59](index=59&type=chunk) RECELL System Clinical Benefits | Indication | Key Benefit | | :--- | :--- | | **2nd-Degree Burns** | Used **97.5% less donor skin** compared to standard care | | **3rd-Degree Burns** | Used **32% less donor skin** when combined with autograft | | **Pediatric Cases** | **56% fewer mean surgical procedures** compared to NBR | Estimated U.S. Addressable Markets | Indication | Estimated Annual Market Size | | :--- | :--- | | **Burns** | ~35,000 patients annually | | **Soft Tissue Repair** | ~$1 billion | | **Vitiligo** | ~$5 billion | - The company has a contract with BARDA valued at approximately **$53.3 million** to support the development of the RECELL System and for emergency preparedness[86](index=86&type=chunk)[87](index=87&type=chunk) - The company's core U.S. patent (No. 9,029,140) covering the RECELL System is in force until February 6, 2024, with a Patent Term Extension (PTE) application filed to extend it to **April 9, 2024**[76](index=76&type=chunk)[78](index=78&type=chunk) [Risk Factors](index=16&type=section&id=Item%201A.%20RISK%20FACTORS) The company faces significant financial, operational, and intellectual property risks, including a history of losses and dependency on regulatory approvals - The company has a history of significant losses, reporting a **net loss of $26.7 million** for the year ended December 31, 2022, and has an **accumulated deficit of $262.6 million**[108](index=108&type=chunk) - Future growth is **highly dependent on obtaining additional FDA approvals** for the RECELL System in new indications, such as soft tissue repair and vitiligo[110](index=110&type=chunk) - The company faces manufacturing risks at its Ventura, California facility and **relies on single-source suppliers** for some components, making it vulnerable to supply chain disruptions[127](index=127&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - A core U.S. patent for the RECELL System will **expire in February 2024**, which could allow competitors to introduce similar products and impair the company's competitive position[150](index=150&type=chunk) - The business is subject to risks from **unfavorable pricing regulations and third-party reimbursement policies** from government or private insurers[121](index=121&type=chunk)[162](index=162&type=chunk) - Macroeconomic risks, including the ongoing effects of the COVID-19 pandemic, supply chain disruptions, inflation, and potential economic recession, could adversely affect customer demand and operating results[165](index=165&type=chunk)[171](index=171&type=chunk) [Unresolved Staff Comments](index=29&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - There are no unresolved staff comments[191](index=191&type=chunk) [Properties](index=29&type=section&id=Item%202.%20PROPERTIES) AVITA Medical leases its corporate office and production plant in California and does not own any real property - The company's principal corporate office is a **17,500 sq. ft.** leased facility in Valencia, California, with the lease expiring on October 31, 2026[191](index=191&type=chunk) - The production plant is a **27,480 sq. ft.** leased facility in Ventura, California, with a lease through September 30, 2024[191](index=191&type=chunk) [Legal Proceedings](index=29&type=section&id=Item%203.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material pending legal proceedings - As of the report date, the company is not a party to any material pending legal proceedings[192](index=192&type=chunk) [Mine Safety Disclosures](index=29&type=section&id=Item%204.%20MINE%20SAFETY%20DISCLOSURES) This section is not applicable to the company's operations - Not applicable[193](index=193&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=30&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock and CDIs trade on Nasdaq and ASX respectively, and it does not anticipate paying cash dividends - The company's common stock is listed on the Nasdaq Capital Market (ticker: **RCEL**) and its CDIs are quoted on the ASX (ticker: **AVH**)[196](index=196&type=chunk) - As of January 31, 2023, the company had approximately **23,190 unique stockholders** of record[197](index=197&type=chunk) - The company has **never paid cash dividends** and does not intend to in the foreseeable future, planning to retain earnings for business use[198](index=198&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenue grew 4% to $34.4 million in 2022, driven by commercial sales, while the net loss widened slightly due to increased operating expenses Results of Operations (Year-Ended Dec 31) | Metric | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | **Revenues** | $34.4M | $33.0M | 4% | | Commercial Revenues | $34.0M | $25.1M | 36% | | **Gross Profit** | $28.4M | $26.9M | 5% | | Gross Margin | 82% | 82% | 0% | | **Total Operating Expenses** | $59.1M | $53.6M | 10% | | **Operating Loss** | ($27.5M) | ($25.1M) | (10)% | | **Net Loss** | ($26.7M) | ($25.1M) | (6)% | - The **35% increase in sales and marketing expenses** in 2022 was driven by higher selling costs, pre-commercialization activities for planned new launches, and an increase in field personnel[212](index=212&type=chunk) - Research and development expenses **decreased by 12%** in 2022 as pivotal trials moved into less costly follow-up phases[215](index=215&type=chunk) Liquidity Position as of Dec 31, 2022 | Item | Amount (in millions) | | :--- | :--- | | Cash and cash equivalents | $18.2 | | Marketable securities | $68.1 | - Net cash used in operating activities was **$19.1 million** for the year ended December 31, 2022, an increase from $18.0 million in the prior year[233](index=233&type=chunk) - Critical accounting policies include revenue recognition under ASC 606, accounting for government grants from BARDA, and share-based compensation[243](index=243&type=chunk)[254](index=254&type=chunk)[257](index=257&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, AVITA Medical is not required to provide this information - The company is not required to provide this information as it qualifies as a smaller reporting company[265](index=265&type=chunk) [Financial Statements and Supplementary Data](index=39&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for fiscal year 2022 and prior periods - The financial statements were audited by Grant Thornton LLP, which issued an **unqualified opinion**[396](index=396&type=chunk) Key Financial Statement Data (as of Dec 31, 2022) | Metric | Amount (in thousands) | | :--- | :--- | | **Balance Sheet** | | | Total Assets | $98,264 | | Total Liabilities | $12,967 | | Total Shareholders' Equity | $84,740 | | **Statement of Operations (FY 2022)** | | | Revenues | $34,421 | | Net Loss | ($26,665) | | **Statement of Cash Flows (FY 2022)** | | | Net Cash Used in Operations | ($19,090) | [Controls and Procedures](index=39&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal controls over financial reporting were effective as of year-end 2022 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2022[268](index=268&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2022, based on the COSO framework (2013)[269](index=269&type=chunk) - **No material changes** were made to the company's internal control over financial reporting during the three months ended December 31, 2022[271](index=271&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=41&type=section&id=Item%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) The company details its board of directors and executive team, committee structures, and compliance with gender diversity targets Board of Directors | Name | Position | | :--- | :--- | | Lou Panaccio | Chairman of the Board | | Jeremy Curnock Cook | Non-Executive Director | | Professor Suzanne Crowe | Non-Executive Director | | Jan Stern Reed | Non-Executive Director | | James Corbett | Executive Director and CEO | Executive Officers | Name | Position | | :--- | :--- | | James Corbett | Chief Executive Officer | | Sean Ekins | Interim Chief Financial Officer | | Erin Liberto | Chief Commercial Officer | | Andrew Quick | Chief Technology Officer | | Donna Shiroma | General Counsel | - The company has achieved its gender diversity target, with the Board of Directors being **40% female** and 60% male[293](index=293&type=chunk) - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, each composed of independent directors[304](index=304&type=chunk)[305](index=305&type=chunk) [Executive Compensation](index=47&type=section&id=Item%2011.%20EXECUTIVE%20COMPENSATION) Executive compensation comprises base salary, performance bonuses, and long-term equity, with CEO James Corbett's 2022 total compensation at $1.5 million 2022 Summary Compensation for Key NEOs | Name and Position | Salary ($) | Bonus ($) | Stock Awards ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **James Corbett**, CEO | 156,992 | 100,726 | - | 1,232,747 | 1,495,584 | | **Michael Holder**, CFO | 430,128 | 184,900 | 178,672 | 82,524 | 925,212 | | **Erin Liberto**, CCO | 421,999 | 180,812 | 178,672 | 82,524 | 906,293 | | **Michael Perry**, Former CEO | 461,512 | - | - | - | 804,498 | - Employment contracts for executive officers provide for severance payments, typically **9-12 months of base salary** and a pro-rated target bonus, upon involuntary termination[326](index=326&type=chunk)[335](index=335&type=chunk) 2022 Non-Employee Director Compensation | Name | Fees in Cash ($) | Stock Awards ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | **L Panaccio**, Chairman | 126,250 | 87,494 | 31,248 | 244,992 | | **J Curnock Cook** | 90,833 | 87,494 | 31,248 | 209,575 | | **S Crowe** | 95,000 | 87,494 | 31,248 | 213,742 | | **J Reed** | 92,500 | 87,494 | 31,248 | 211,242 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=53&type=section&id=Item%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) No beneficial owners hold over 5% of common stock, while all executive officers and directors as a group own 4.21% - There are **no known beneficial owners of more than 5%** of the company's common stock as of January 31, 2023[347](index=347&type=chunk) Beneficial Ownership of Management (as of Jan 31, 2023) | Holder | Percentage of Class | | :--- | :--- | | **Michael Perry** (Former CEO) | 1.01% | | **All executive officers and directors as a group (13 persons)** | 4.21% | - As of January 31, 2023, the company had **25,296,086 shares** of common stock outstanding, with a significant portion held as CDIs on the ASX[356](index=356&type=chunk) [Certain Relationships and Related Party Transactions, and Director Independence](index=58&type=section&id=Item%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20PARTY%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) The company reports no material related party transactions and confirms the independence of all board members except for the CEO - The company has not participated in any related party transaction involving more than **$120,000** since January 1, 2021[375](index=375&type=chunk) - All members of the Board of Directors are considered independent, **except for James Corbett**, who serves as the company's Chief Executive Officer[376](index=376&type=chunk) [Principal Accounting Fees and Services](index=58&type=section&id=Item%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Total fees billed by auditor Grant Thornton LLP for 2022 were $740,013, covering audit and tax services Principal Accountant Fees (Year-Ended Dec 31, 2022) | Service | Fees ($) | | :--- | :--- | | Audit Fees | 652,732 | | Tax Fees | 87,281 | | **Total Fees** | **740,013** | - All audit and non-audit services provided by the independent registered public accounting firm were **pre-approved by the Audit Committee**[380](index=380&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=59&type=section&id=Item%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists all documents filed with the report, including financial statements, material contracts, and corporate governance documents - This item provides an index of all financial statements, schedules, and exhibits filed with the Form 10-K[382](index=382&type=chunk) - Exhibits include corporate governance documents, material contracts (including the BARDA agreement), lease agreements, and executive compensation plans and agreements[384](index=384&type=chunk)[385](index=385&type=chunk) [Form 10-K Summary](index=61&type=section&id=Item%2016.%20Form%2010-K%20Summary) This section is noted as 'None', indicating no summary is provided - No Form 10-K summary is provided[387](index=387&type=chunk)

AVITA Medical, Inc. (NASDAQ:RCEL) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Caroline Corner - Managing Director, Investor Relations Jim Corbett - Chief Executive Officer Michael Holder - Chief Financial Officer Conference Call Participants Charlie Montang - Lake Street Capital Matthew O’Brien - Piper Sandler Ryan Zimmerman - BTIG Joshua Jennings - Cowen Madeleine Williams - Wilsons Operator Good day and thank you for standing by and welcome to AVITA Medical Third Qua ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 85-1021707 (IRS Employer Identification No.) 28159 Avenue Stanford FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION ...

Financial Data and Key Metrics Changes - The company reported record commercial RECELL revenues of $8.2 million for Q2 2022, a 23% increase from $6.7 million in the same quarter last year [9] - Total revenue for Q2 2022 was $8.3 million, down from $10.3 million in the prior year, which included $3.6 million in BARDA revenue [32] - Gross profit margin improved by 3% to 83% compared to the prior year [33] - Net loss increased by 33% to $6.3 million, or $0.25 per share, compared to a net loss of $4.7 million, or $0.19 per share, in the prior year [35] - Adjusted EBITDA loss increased by 51% to $4.7 million compared to $3.1 million in the prior year [36] Business Line Data and Key Metrics Changes - Commercial revenue for the first half of 2022 was $15.7 million, a 39% increase from $11.3 million in the same period last year [10] - The company achieved greater penetration and a larger base of accounts, leading to an increase in burn cases treated with RECELL [11] - The outpatient market is expected to become a larger portion of the addressable market, with ongoing efforts to familiarize centers with outpatient care pathways [14] Market Data and Key Metrics Changes - In Japan, the company completed its first training and evaluation cases during the quarter, with ongoing discussions regarding reimbursement and pricing [15] - The company anticipates that outpatient treatment will comprise the core soft tissue market, supporting continued growth [14] Company Strategy and Development Direction - The company is focused on driving healthcare provider engagement through education and maintaining momentum in burn treatments [28] - Plans to submit PMA supplements for soft tissue reconstruction and vitiligo indications by the end of 2022, with market entry anticipated in the second half of 2023 [29] - The company aims to leverage its existing infrastructure to launch RECELL in trauma centers co-located with burn centers [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving projected commercial revenue of approximately $30 million for 2022, representing a 20% year-over-year increase [42] - Concerns were raised regarding potential supply chain issues, macroeconomic factors, and staffing shortages in hospitals affecting growth [55] - Management noted that labor shortages have stabilized but have not improved, with increased training efforts to address staffing challenges [56] Other Important Information - The company is developing an automated RECELL device to improve efficiency in dermatology practices [24] - The RECELL system is expected to differentiate itself in the vitiligo market due to its strong safety record and treatment procedure [26] Q&A Session Summary Question: Clarification on soft tissue trial data and non-inferiority - Management explained that while donor skin sparing was statistically significant, non-inferiority for healing was not met at the pre-specified level, but they remain confident in the PMA submission [45][46] Question: Safety events in the study - Management confirmed that there were no differences in adverse events between the control and treated groups [49] Question: Updates on vitiligo trial data presentation - Management indicated that top-line data from the vitiligo trial would be released shortly, and they are currently pursuing a go-it-alone strategy for commercialization [51] Question: Guidance for the second half of the year - Management reiterated confidence in the $30 million revenue guidance, citing seasonality and external factors as reasons for not increasing guidance [55] Question: Labor shortages and improvements - Management noted that while labor shortages have stabilized, they have not improved, and training efforts have increased to address this issue [56] Question: Adoption and reimbursement in Japan - Management expressed optimism about reimbursement discussions in Japan and indicated that they expect favorable pricing [63][64] Question: Maintenance of gross margins - Management stated that they aim to maintain gross margins at the low 80% level moving forward [67]