Full Press Release Details
AVITA Medical Reports First Quarter Financial Results and Affirms Full Year Guidance
VALENCIA, California, May 11, 2023 and MELBOURNE, Australia, May 12, 2023 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 first quarter March 31, 2023.
Financial Highlights and Recent
With a solid first quarter, we are on track to deliver a year of significant growth revenue, said Jim Corbett, AVITA
Medical Chief Executive Officer. The onboarding and training of our expanded U.S. field sales organization is underway, and we believe we will be fully prepared for the commercial launch of the soft tissue repair indication following expected
FDA approval in June. Further, we are on track to submit our PMA supplement to the FDA for RECELL GO by the end of the second quarter. We believe RECELL GO is a critical component of our platform and has the potential to significantly accelerate our
Organizational Update
Mr. Terry Bromley has been promoted to Senior Vice President of Global Sales and Ms. Debbie Garner has been promoted to Senior Vice President of
Global Marketing and Strategy. Mr. Bromley and Ms. Garner will report directly to Jim Corbett, Chief Executive Officer of AVITA Medical.
May 11, 2023, Ms. Erin Liberto resigned from her position as Chief Commercial Officer to accept a role with a privately held, non-competing business.
First Quarter 2023 Financial Results
revenue, which excludes BARDA revenue, increased by 40% to $10.5 million in the three-months ended March 31, 2023, compared to $7.4 million in the same period in 2022. Total revenue, which includes BARDA revenue, increased by 40% to
$10.6 million compared to $7.5 million in the same period in 2022.
The gross profit margin was increased by 8% to 84% compared to 76% for the
first quarter of 2022.
Total operating expenses for the quarter increased by 22% to $19.4 million, compared to $16.0 million in the same period
in 2022, primarily due to increased field expansion and continued development of the RECELL GO device for the planned submission in June 2023.
decreased by 3% to $9.2 million, or $0.37 per share, compared to a net loss of $9.5 million, or $0.38 per share, in the same period in 2022.
Adjusted EBITDA* loss remained flat at $6.4 million.
Webcast and Conference Call Information
host a conference call to discuss the first quarter financial results and, recent business highlights on Thursday, May 11, 2023, at 1:30 p.m. Pacific Time (being Friday, May 12, 2023, at 6:30 a.m. Australian Eastern Daylight Standard
Time). To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique
personal PIN that can be used to join the call. A simultaneous webcast of the call will be available via the Company s website at https://ir.avitamedical.com.
Authorized for release by the Chief Executive Officer of AVITA Medical, Inc.
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 FDA for the treatment of acute thermal burns in both adults and children, 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 and validated cost savings. 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, including soft tissue repair and repigmentation of stable vitiligo lesions.
AVITA Medical s 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. In February 2022,
the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.
The RECELL System is used to prepare Spray-On Skin Cells
using a small amount of a patient s 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 15,000 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 approved under the RECELL System brand to promote skin healing in a wide range of applications including burns,
soft tissue repair, vitiligo, and aesthetics. 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.
* Use of non-GAAP Measure
AVITA Medical s reported earnings are prepared in accordance with generally accepted
accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. AVITA Medical has provided in this release certain financial information that has not been prepared in accordance with
GAAP. AVITA Medical s management believes that the non-GAAP adjusted EBITDA described in the release, which includes adjustments for specific items that are generally not indicative of our core
operations, provides additional information that is useful to investors in understanding AVITA Medical s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in AVITA Medical s industry. However, the non-GAAP financial measures
that AVITA Medical uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or
as substitutes for results prepared in accordance with GAAP.
CAUTIONARY NOTE REGARDING 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.
FOR FURTHER INFORMATION:
Consolidated Balance Sheets
(In thousands, except share and per share data)
| As of March 31, 2023 | As of December 31, 2022 | |||||||
| ASSETS | ||||||||
| Cash and cash equivalents | $ | 28,050 | $ | 18,164 | ||||
| Marketable securities | 45,401 | 61,178 | ||||||
| Accounts receivable, net | 4,502 | 3,515 | ||||||
| BARDA receivables | 516 | 898 | ||||||
| Prepaids and other current assets | 1,481 | 1,578 | ||||||
| Inventory | 2,811 | 2,125 | ||||||
| Total current assets | 82,761 | 87,458 | ||||||
| Marketable securities long-term | 4,189 | 6,930 | ||||||
| Plant and equipment, net | 1,333 | 1,200 | ||||||
| Operating lease right-of-use assets | 1,815 | 851 | ||||||
| Corporate-owned life insurance asset | 1,833 | 1,238 | ||||||
| Intangible assets, net | 461 | 465 | ||||||
| Other long-term assets | 230 | 122 | ||||||
| Total assets | $ | 92,622 | $ | 98,264 | ||||
| LIABILITIES, NON-QUALIFIED DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS EQUITY | ||||||||
| Accounts payable and accrued liabilities | 3,752 | 3,002 | ||||||
| Accrued wages and fringe benefits | 3,665 | 6,623 | ||||||
| Current non-qualified deferred compensation liability | 2,140 | 78 | ||||||
| Other current liabilities | 1,929 | 990 | ||||||
| Total current liabilities | 11,486 | 10,693 | ||||||
| Non-qualified deferred compensation liability | 1,165 | 1,270 | ||||||
| Contract liabilities | 382 | 698 | ||||||
| Operating lease liabilities, long term | 1,235 | 306 | ||||||
| Total liabilities | 14,268 | 12,967 | ||||||
| Non-qualified deferred compensation plan share awards | 793 | 557 | ||||||
| Contingencies (Note 12) | ||||||||
| Stockholders equity: | ||||||||
| Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,327,761 and 25,208,436 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 3 | 3 | ||||||
| Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at March 31, 2023 and December 31, 2022. | ||||||||
| Company common stock held by the non-qualified deferred compensation plan | (892 | ) | (127 | ) | ||||
| Additional paid-in capital | 342,400 | 339,825 | ||||||
| Accumulated other comprehensive income | 7,858 | 7,627 | ||||||
| Accumulated deficit | (271,808 | ) | (262,588 | ) | ||||
| Total stockholders equity | 77,561 | 84,740 | ||||||
| Total liabilities, non-qualified deferred compensation plan share awards and stockholders equity | $ | 92,622 | $ | 98,264 |
Consolidated Statements of Operations
(In thousands, except share and per share data)
| Three- Months Ended | ||||||||
| March 31, 2023 | March 31, 2022 | |||||||
| Revenues | $ | 10,550 | $ | 7,539 | ||||
| Cost of sales | (1,667 | ) | (1,778 | ) | ||||
| Gross profit | 8,883 | 5,761 | ||||||
| BARDA income | 627 | 734 | ||||||
| Operating expenses: | ||||||||
| Sales and marketing expenses | (6,540 | ) | (4,828 | ) | ||||
| General and administrative expenses | (8,295 | ) | (7,534 | ) | ||||
| Research and development expenses | (4,586 | ) | (3,620 | ) | ||||
| Total operating expenses | (19,421 | ) | (15,982 | ) | ||||
| Operating loss | (9,911 | ) | (9,487 | ) | ||||
| Interest expense | (4 | ) | ||||||
| Other income | 725 | 28 | ||||||
| Loss before income taxes | (9,190 | ) | (9,459 | ) | ||||
| Provision for income tax | (30 | ) | (4 | ) | ||||
| Net loss | $ | (9,220 | ) | $ | (9,463 | ) | ||
| Net loss per common share: | $ | (0.37 | ) | $ | (0.38 | ) | ||
| Basic | $ | (0.37 | ) | $ | (0.38 | ) | ||
| Diluted | ||||||||
| Weighted-average common shares: | 25,202,088 | 24,937,999 | ||||||
| Basic | 25,202,088 | 24,937,999 | ||||||
| Diluted |
| Three-Months Ended | ||||||||
| (In thousands) | March 31, 2023 | March 31, 2022 | ||||||
| Sales and marketing expenses | $ | 325 | $ | 329 | ||||
| General and administrative expenses | 2,090 | 2,327 | ||||||
| Research and development expenses | 225 | 276 | ||||||
| Total | $ | 2,640 | $ | 2,932 |
Reconciliation of reported Net Loss (GAAP) to Adjusted EBITDA (NON-GAAP) Measure Unaudited
| Three-Months Ended | ||||||||
| (In thousands) | March 31, 2023 | March 31, 2022 | ||||||
| Net Loss | $ | (9,220 | ) | $ | (9,463 | ) | ||
| Depreciation expense | 126 | 129 | ||||||
| Patent Amortization | 9 | 34 | ||||||
| Share-based expense | 2,640 | 2,932 | ||||||
| Interest Expense | 4 | |||||||
| Income Tax Expense | 30 | 4 | ||||||
| Adjusted EBITDA (Non-GAAP) | $ | (6,411 | ) | $ | (6,364 | ) |