GlobeNewswire Inc | Aug 26, 2021 04:01PM EDT

August 26, 2021

VALENCIA, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX:AVH) (Company), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today reported financial results for its fourth quarter of fiscal year 2021, ended June 30, 2021.

Fourth Quarter of Fiscal Year 2021 Highlights

-- Total net revenue increased 166% to $10.3 million compared to $3.9 million in the fourth quarter of 2020 -- Total commercial revenue increased 45% to $6.7 million compared to the prior quarter ended March 31, 2021 and exceeded revised revenue guidance of $6.0-6.2 million -- Gross profit margin of 80% compared to 77% in the fourth quarter of 2020 -- Net loss of $4.7 million, or $0.19 per share compared to a net loss of $12.9 million, or $0.60 per share in the fourth quarter of 2020 -- As of June 30, 2021, the Company had $110.7 million in cash and cash equivalents, and no debt -- FDA approved expanded use of the RECELL System in combination with meshed autografting for the treatment of all sizes of acute full-thickness thermal burn wounds for both pediatric and adult patients

Full-Year of Fiscal 2021 Highlights

-- Total net revenue increased 105% to $29.2 million compared to $14.3 million in the prior year -- Commercial revenues increased 50% compared to the prior year -- Gross profit margin of 80% compared to 79% in the prior year -- Net loss of $26.6 million, or $1.17 per share compared to a net loss of $42.0 million, or $2.07 per share, in the prior year

We are excited to report our substantial progress this quarter. As COVID-related restrictions decreased and people resumed everyday activities, the organization was well-positioned for the marked increase in burn-related accidents, said Dr. Mike Perry, AVITA Medical Chief Executive Officer. We realized a significant revenue increase primarily from the increase in burn cases but also from our further penetration in burn center accounts. We also realized an acceleration of enrollment into our soft tissue reconstruction trial, which is now over half enrolled at 36 of 65 subjects.

Fourth Quarter of Fiscal 2021 Financial ResultsTotal net revenue increased 166% to $10.3 million, compared to $3.9 million in the corresponding period in the prior year. RECELL commercial revenues increased 72% to $6.7 million, while RECELL revenues associated with the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response (BARDA) were $3.6 million. Revenues associated with BARDA were attributable to the purchase of RECELL units for emergency preparedness by BARDA.

Gross profit margin improved by 3% to 80% compared to the corresponding period in the prior year. The increase in gross profit margin was driven by lower shipping costs and increased production.

Total operating expenses decreased by 19% to $13.4 million compared to $16.5 million in the corresponding period in the prior year. The decrease in operating expenses is primarily attributable to lower stock-based compensation and higher costs in the prior year related to the Avita groups redomiciliation to the United States (Redomiciliation), which were partially offset by higher costs in research and development. Lower stock-based compensation was driven by higher share-based compensation expenses in the prior year associated with certain performance milestones being met. Higher research and development expenses have resulted from a ramping up of activities related to clinical trials in vitiligo and soft tissue reconstruction, research in RECELL related cell and gene therapies, and initiatives to further improve the RECELL platform technology.

Net loss decreased by 63% or $8.1 million to $4.7 million, or $0.19 per share, compared to a net loss of $12.9 million, or $0.60 per share, in the corresponding period of the prior year.

Full-Year 2021 Financial ResultsTotal net revenue increased by 105% to $29.2 million, compared to $14.3 million in the corresponding period in the prior year. RECELL commercial revenues increased by 50% or $7.2 million to $21.5 million, while RECELL revenues associated with BARDA were $7.7 million. Revenues associated with BARDA were attributable to the purchase of RECELL units for emergency preparedness by BARDA.

Gross profit margin increased by 1% to 80%, compared with 79% in the prior year, driven largely by lower shipping costs, increased production, and lower costs resulting from the extension of RECELL shelf-life.

Total operating expenses decreased by 10% or $6.0 million to $51.9 million, compared with $57.9 million in the corresponding period in the prior year. The decrease in operating costs is primarily attributable to lower stock-based compensation, higher costs in the prior year related to the Redomiciliation along with lower sales and marketing costs in the current year, partially offset by higher costs in research and development in the current year. Lower stock-based compensation was driven by higher share-based compensation expenses in the prior year associated with certain performance milestones being met. The decrease in sales and marketing costs in the current year is primarily due to reduced commercial team travel to burn centers and industry conferences necessitated by COVID-19 related travel restrictions, and higher prior year costs incurred with the RECELL product launch. Higher research and development expenses have resulted from a ramping up of clinical trial related activities for the treatment of vitiligo and further improvements to the RECELL platform technology.

Net loss decreased by 37% or $15.4 million to $26.6 million or $1.17 per share, compared to a net loss of $42.0 million or $2.07 per share in the corresponding period in the prior year.

First Quarter of Fiscal Year 2022 Revenue Guidance

-- Total commercial revenue is expected to be approximately $7.0 million

Webcast and Conference Call InformationThe Company will host a conference call to discuss the fourth quarter financial results after market close on Thursday, August 26, 2021, at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (being 6.30 a.m. Australian Eastern Standard Time on Friday, August 27, 2021). The conference call can be accessed live over the phone for (833) 614-1538 U.S. callers or for (706) 634-6548 international callers, using conference ID:3858364. The live webinar can be accessed at https://ir.avitamedical.com.

Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.

ABOUT AVITA Medical, INC.AVITA Medical, Inc. is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical Inc. patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device ( https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.To learn more, visit www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSThis press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational, and financial goals. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions including, but not limited to the ongoing COVID-19 pandemic which are outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

FOR FURTHER INFORMATION:

U.S. MediaSam Brown, Inc.Christy CurranPhone +1 615 414 8668 Investorschristycurran@sambrown.com Westwicke Partners Caroline CornerO.U.S Media Phone +1 415 202 5678Monsoon Communications caroline.corner@westwicke.comRudi MichelsonPhone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.au



AVITA MEDICAL, INC. Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited)

As of June 30, June 30, 2021 2020ASSETS Cash $ 110,746 $ 73,639 Accounts 3,467 2,076 receivable, netBARDA receivables 3,936 356 Prepaids andother current 1,333 990 assetsRestricted cash 201 201 Inventory 1,647 1,125 Total current 121,330 78,387 assetsPlant and 1,458 1,363 equipment, netOperating leaseright-of-use 1,480 2,347 assetsIntangible 472 364 assets, netOther long-term 761 1 assetsTotal assets $ 125,501 $ 82,462 LIABILITIES ANDSHAREHOLDERS' EQUITYAccounts payableand accrued $ 3,120 $ 4,333 liabilitiesAccrued wages and 3,321 2,816 fringe benefitsOther current 560 liabilities 949Total current 7,390 7,709 liabilitiesContract 1,075 435 liabilitiesOperating leaseliabilities, long 878 1,917 termOther long-term - liabilities 503Total liabilities 9,846 10,061 Contingencies (Note 10)Shareholders' Equity:Common stock,$0.0001 par valueper share,200,000,000sharesauthorized,24,895,864 and 3 3 21,467,912 sharesissued andoutstanding atJune 30, 2021,and June 30,2020,respectivelyPreferred stock,$0.0001 par valueper share,10,000,000 sharesauthorized, no - - shares issued oroutstanding atJune 30, 2021,and June 30, 2020Additional 328,889 259,165 paid-in capitalAccumulated othercomprehensive 8,259 8,146 incomeAccumulated (221,496 ) (194,913 )deficitTotalshareholders' 115,655 72,401 equityTotal liabilitiesand shareholders' $ 125,501 $ 82,462 equity The accompanying notes form part of the consolidated financial statements

AVITA MEDICAL, INC. Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited)

ThreemonthsendedJune 30, Year ended June 30, 2021 2020 2021 2020 Revenues $ 10,304 $ 3,877 $ 29,232 $ 14,263 Cost of sales (2,053 ) (874 ) (5,949 ) (2,973 )Gross profit 8,251 3,003 23,283 11,290 BARDA income 440 481 2,055 3,926 Operating expenses:Sales andmarketing (4,146 ) (4,260 ) (14,660 ) (15,706 )expenses^(1)General andadministrative (5,275 ) (9,709 ) (22,400 ) (33,025 )expenses^(1)Research anddevelopment (3,974 ) (2,538 ) (14,818 ) (9,164 )expenses^(1)Total operating (13,395 ) (16,507 ) (51,878 ) (57,895 )expensesOperating loss (4,704 ) (13,023 ) (26,540 ) (42,679 )Interest expense (9 ) (8 ) (22 ) (33 )Other income/ 2 121 17 686 (expense)Loss before (4,711 ) (12,910 ) (26,545 ) (42,026 )income taxesIncome tax (7 ) (4 ) (38 ) (4 )expenseNet loss $ (4,718 ) $ (12,914 ) $ (26,583 ) $ (42,030 )Net loss per common share:Basic $ (0.19 ) $ (0.60 ) $ (1.17 ) $ (2.07 )Diluted $ (0.19 ) $ (0.60 ) $ (1.17 ) $ (2.07 )Weighted-average common shares:Basic 24,860,738 21,372,892 22,674,313 20,290,966 Diluted 24,860,738 21,372,892 22,674,313 20,290,966

(1) Total operating expenses include impact of share-based compensation as follows: ThreeMonthsEnded Year Ended June 30, June 30, 2021 2020 2021 2020 Sales andmarketing $ (63 ) $ (309 ) $ (925 ) $ (893 )expensesGeneral andadministrative (1,173 ) (3,348 ) (4,095 ) (14,890 )expensesResearch anddevelopment (175 ) (206 ) (644 ) (703 )expensesTotal $ (1,411 ) $ (3,863 ) $ (5,664 ) $ (16,486 )