VALENCIA, Calif.andMELBOURNE, Australia,Nov. 10, 2022(GLOBE...

VALENCIA, Calif.andMELBOURNE, Australia,Nov. 10, 2022(GLOBE NEWSWIRE) --AVITA Medical, Inc.(NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today reported financial results for the third quarter ended September 30, 2022.

Third Quarter Highlights and Recent Updates:

1. Reported commercial revenue, which excludes BARDA revenue, of$9.0 million, a 30% increase compared to$6.9 millionin the corresponding period in the prior year
2. Reported total revenue, which includes BARDA revenue, of$9.1 millioncompared to$7.0 millionin the corresponding period in the prior year
3. Gross profit margin was 83%
4. Topline results from its pivotal randomized controlled trial evaluating the safety and effectiveness of the RECELL® System for healing of soft tissue repair with reduced donor skinCo-primary endpoints were met for superiority relative to donor skin sparing and for non-inferiority relative to healing
5. Topline results from its pivotal randomized controlled trial evaluating the safety and effectiveness of the RECELL® System for repigmentation for stable vitiligoSuper-superiority was established for the primary endpoint
6. The Company plansU.S. Food and Drug Administration(FDA) submissions for soft tissue repair and vitiligo indications inDecember 2022
7. Breakthrough Device designation provided by the FDA for the RECELL System for soft tissue repair and vitiligo
8. The Japanese MHLW (Ministry of Health, Labor, and Welfare) granted the RECELL System marketing approval with pricing to end-customers equivalent to ourU.S.pricing. Our partner inJapan, COSMOTEC, anM3 Company, will launch commercial RECELL inJapanin Q4 2022
9. As of September 30, 2022, the Company had$88.2 millionin cash, cash equivalents, and marketable securities, with no debt

“Over the next 24 to 36 months, our growth is expected to be driven by the burns and soft tissue repair markets,” saidJim Corbett,AVITA MedicalChief Executive Officer. “Soft tissue repair will expand our hospital and treating physician call points by nearly three times. We are prepared to make the necessary investment in our commercial organization to support this expansion. This market opportunity expansion and the related revenue growth is the number one priority of AVITA Medical.”

Three Months EndedSeptember 30, 2022Financial Results

Our commercial revenue, which excludes BARDA revenue, increased by 30% or$2.1 millionto$9.0 millionin the three months endedSeptember 30, 2022, compared to$6.9 millionin the corresponding period in the prior year. Total revenue, which includes BARDA revenue, increased 30% or$2.1 millionto$9.1 millioncompared to$7.0 millionin the corresponding period in the prior year. The growth in commercial revenues was largely driven by deeper penetration within individual customer accounts along with the commencement of commercial sales with our partner COSMOTEC inJapan.

Gross profit margin decreased by 2% to 83% compared to the corresponding period in the prior year.

Total operating expenses increased by 16% or$2.0 millionto$14.2 millioncompared to$12.3 millionin the corresponding period in the prior year. The increase in operating expenses is attributable to higher compensation costs, pre-commercialization costs, research and development expenses, partially offset by lower share-based compensation expenses. Higher compensation costs were primarily a result of an expansion of our commercial team along with an increase in commissions which resulted from an increase in commercial revenues. In addition, we incurred severance costs in the current quarter associated with the termination of a former executive employee. Higher pre-commercialization costs are driven by activities related to future RECELL launches in soft tissue reconstruction and vitiligo. Increased research and development expenses resulted from ongoing development of next generation devices for an automated preparation of Spray-On Skin™ Cells. Higher research and development expenses were partially offset by lower clinical trial expenses for soft tissue reconstruction and vitiligo as trial participants were in less costly follow-up phases this period compared to more costly recruitment and treatment phases in the prior period. Share-based compensation expense was lower in the current period as certain performance milestones were met in the prior period, and there was a reversal in the current period of previously recognized expense for unvested awards related to the termination of an executive officer.

Net loss decreased by 6% or$0.4 millionto$5.6 million, or$0.22per share, compared to a net loss of$5.9 million, or$0.24per share, in the corresponding period of the prior year.

Adjusted EBITDA* loss increased by 2% or$84 thousandto$4.0 million, compared to a loss of$3.9 millionin the corresponding period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

2022 Revenue Guidance

Turning to guidance, full year 2022 commercial revenue (excluding BARDA revenues) is expected to be$33.0-34.0 million, an increase from our prior guidance of$30 million, and an approximate 33% increase year-over-year. We continue to project BARDA revenues of approximately$0.3 millionin calendar year 2022.