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AVITA Medical Announces Preliminary Third Quarter 2023 Financial Highlights and Secures up to $90 million of Non-Dilutive Debt Financing with OrbiMed to Support Growth Initiatives

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AVITA Medical reports preliminary commercial revenue of $13.5 million for Q3 2023 and confirms full year 2023 guidance
Positive
  • Preliminary commercial revenue for Q3 2023 increased by 50% compared to the same period in 2022
  • Gross margin for Q3 was approximately 84.5%
  • Additional non-dilutive capital of up to $50 million available based on certain revenue thresholds
  • Capital from the debt financing facility will support strategic expansion and growth
Negative
  • None.
  • Preliminary commercial revenue of $13.5 million for the third quarter 2023; full year 2023 guidance confirmed
  • $40 million funded at close; $50 million of additional non-dilutive capital available at the Company’s option, based on the achievement of certain revenue thresholds
  • Capital from the transaction will support execution of strategic expansion and fuel continued growth

VALENCIA, Calif., Oct. 18, 2023 (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 announced third quarter 2023 financial highlights and the closing of a debt financing facility for up to $90 million with OrbiMed, a healthcare investment firm. The non-dilutive capital provides financial flexibility to support portfolio expansion, global initiatives, and the further development and commercialization of approved indications.

For the third quarter ended September 30, 2023, preliminary commercial revenue was $13.5 million, a 50% increase compared to approximately $9.0 million for the same period in 2022. Gross margin for the third quarter was approximately 84.5%. Guidance for full year 2023 commercial revenue remains unchanged and is expected to be in the range of $51 to $53 million.

Under the terms of the Credit Agreement (the “Credit Agreement”) with OrbiMed, the Company borrowed $40 million at closing. In addition, an aggregate of an additional $50 million is available in two tranches at the Company’s option, based on the achievement of certain revenue thresholds. The Credit Agreement has a five-year term that matures in October 2028. AVITA Medical also issued OrbiMed a warrant to purchase 409,661 shares of the Company’s common stock, with an exercise price of $10.9847.

“After another strong quarter, we are excited to be partnering with OrbiMed,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “This transaction provides us with the capital to execute strategic growth initiatives as we continue to transform our business. We believe this financing provides us with sufficient capital to meet our goals without the near-term need of equity financing and positions us to reach profitability during 2025.”

Matthew Rizzo, General Partner of OrbiMed, added, “We are excited to support AVITA Medical as they pursue their strategic objectives, providing them with the necessary capital for financial flexibility, enabling future portfolio expansion, global initiatives, and the continued advancement and commercialization of their approved indications, solidifying their position as a leader in regenerative medicine.”

Further details regarding the Credit Agreement, Pledge and Security Agreement, and the Warrant are set out in a Form 8-K filed by the Company with the U.S. Securities and Exchange Commission on October 18, 2023, and disclosed on the Australian Securities Exchange.

About AVITA Medical, Inc.
AVITA Medical® is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. The RECELL® System technology platform, approved by the Food and Drug Administration for the treatment of thermal burn wounds and full-thickness skin defects and for repigmentation of stable depigmented vitiligo lesions, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin cells. Delivered at the point-of-care, RECELL enables improved clinical outcomes. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications.

In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, full-thickness skin defects and vitiligo. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan.

To learn more, visit www.avitamedical.com.

About OrbiMed
OrbiMed is a healthcare investment firm, with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, London, Herzliya and other key global markets.

Forward-Looking Statements
This 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 goal. 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 statements. Applicable risks and uncertainties include, among others, the timing and realization 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 outside of the company’s 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.

Investor & Media Contact:
Jessica Ekeberg
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com

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


FAQ

What was AVITA Medical's preliminary commercial revenue for Q3 2023?

AVITA Medical reported preliminary commercial revenue of $13.5 million for Q3 2023, which is a 50% increase compared to the same period in 2022.

What was the gross margin for AVITA Medical in Q3?

The gross margin for AVITA Medical in Q3 was approximately 84.5%.

How much additional non-dilutive capital is available to AVITA Medical?

AVITA Medical has up to $50 million of additional non-dilutive capital available based on the achievement of certain revenue thresholds.

What will the capital from the debt financing facility support?

The capital from the debt financing facility will support strategic expansion and fuel continued growth for AVITA Medical.

Avita Medical, Inc.

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Surgical and Medical Instrument Manufacturing
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About RCEL

avita medical (http://www.avitamedical.com/) is a publicly listed regenerative medicine company trading on the australian stock exchange (asx:avh) and otc markets (otcqx:avmxy). the company’s lead product, recell® is used in a wide variety of burns, chronic wounds, plastic, reconstructive and cosmetic procedures. recell is patented, ce-marked for europe, tga- registered in australia, and sfda-cleared in china. recell is not available for sale in the united states; in the us recell is an investigational device limited by federal law to investigational use.