AVITA Medical Reports First Quarter 2022 Financial Results

AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “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 first quarter ended March 31, 2022.

Financial Highlights and Recent Updates:

• Reported commercial revenue, which excludes BARDA revenue, of $7.4 million a 61% increase compared to $4.6 million in the corresponding period in the prior year
• Reported total revenue, which includes BARDA revenue, of $7.5 million compared to $8.8 million in the corresponding period in the prior year, which included $4.1 million in BARDA revenue
• In February 2022, FDA approved our premarket approval application (PMA) supplement for RECELL® Autologous Cell Harvesting Device, an enhanced RECELL system aimed at providing clinicians a more efficient user experience and simplified workflow
• In February 2022, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved our application for commercialization of the RECELL system in burns
• As of March 31, 2022, the Company had $95.0 million in cash, cash equivalents, and marketable securities, with no debt

“Our commercial team performed well this quarter driving further adoption and penetration within burn centers, and our clinical team continued to move the soft tissue reconstruction and vitiligo trials forward,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “We are well positioned to drive revenue growth ahead and we look forward to topline data readouts from our soft tissue reconstruction and vitiligo clinical trials in the second half of this year.”

First Quarter of Year 2022 Financial Results

Our commercial revenue, which excludes BARDA revenue, was $7.4 million in the current year, an increase of $2.8 million or 61%, compared to $4.6 million the corresponding period in the prior year. Total revenue, which includes BARDA revenue, was $8.8 million in the corresponding period in the prior year which included $4.1 million in BARDA related revenue that resulted from our delivery of units to managed inventory for BARDA for emergency response preparedness. The increase in commercial revenue was largely driven by broader utilization among our customer base as well as deeper penetration within individual customer accounts.

Gross profit margin was 76% and is flat compared to the corresponding period in the prior year.

Total operating expenses increased by 21% to $16.0 million compared to $13.2 million in the corresponding period in the prior year. The increase in operating expenses is primarily attributable to higher share-based compensation, salary, and benefits. Higher share-based compensation expenses are associated with acceleration of expense for certain performance milestones being met in the current quarter. Higher salary and benefits are driven by the expansion of our workforce to support the overall operations, an increase in field resources to expand our market coverage and hiring of an executive at the end of March 2021.

Net loss increased by 58% or $3.5 million to $9.5 million, or $0.38 per share, compared to a net loss of $6.0 million, or $0.26 per share, in the corresponding period of the prior year.

Adjusted EBITDA* loss increased by 42%, or $1.9 million to $6.4 million, over the $4.5 million recognized in the corresponding period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

Calendar Year 2022 Revenue Guidance

Commercial revenues in calendar year 2022 are projected to be approximately $30 million, excluding BARDA revenues, which represents a 20% increase year-over year. We project BARDA revenues of approximately $0.3 million in calendar year 2022, as compared to $7.9 million in calendar year 2021, since we completed delivery of RECELL units into the national stockpile in 2021.

*Adjusted EBITDA is a non-GAAP financial measure. See the appendix to this release for a discussion of Non-GAAP financial measures, including a reconciliation to the most closely correlated GAAP measure.

Webcast and Conference Call Information

The Company will host a conference call to discuss the first quarter financial results after market close on Thursday May 12, 2022, at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (being 6.30 a.m. Australian Eastern Standard Time on Friday May 13, 2022). The conference call can be accessed live over the phone at (833) 614-1538 for U.S. callers or at (706) 634-6548 international callers, using conference ID:2592487. The live webinar can be accessed at https://ir.avitamedical.com.