Financial Highlights and Recent Updates
- Commercial revenue of
$13.5 million , an approximately 51% increase compared to$9.0 million for the same period in 2022 - Gross margin of 84.5% for the quarter
- Announced international expansion plan; engaged first European distribution partner,
PolyMedics Innovations GmbH , to lead expansion intoGermany ,Austria , andSwitzerland - In October, secured a debt financing facility for up to
$90.0 million , of which$40.0 million was borrowed at closing. Together with the cash on hand of$60.1 million as ofSeptember 30, 2023 , the Company believes it has sufficient capital to meet its goals and to reach profitability during 2025.
“We continue to execute our growth strategy, paving the way to profitability,” said
Future Milestones
- Expect FDA real-time review of the PMA Supplement for RECELL GO™ to resume on
March 1, 2024 , day 91 of the 180-day review cycle, with FDA approval anticipated onMay 30, 2024 - Reaffirming high growth potential of full-thickness skin defect indication, which presents a market 10 times the size of original burns market
- Plan to actively identify new international distributor partnerships, including
Australia ,Japan , andEuropean Union , over the next 6 to 12 months - Expect full enrollment of post-market study, TONE, by end of
February 2024 - Initiating health care economics study to capture longitudinal healthcare costs of vitiligo patients
- Expect initial reimbursement coverage for vitiligo in Q3 2025
- Expect to reach profitability in 2025
“We have achieved significant commercial revenue growth rates for the last three quarters of 40%, 42% and 51%, respectively, over the same periods in the previous year,” said David O’Toole, Chief Financial Officer of
Financial Guidance
- Commercial revenue for the fourth quarter 2023 is expected to be in the range of
$15.3 to$16.3 million , reflecting a lower bound of 64% and upper bound of 73% growth over the same period in the prior year - Commercial revenue for the full year 2023 is expected to be in the range of
$51 to$53 million , reflecting a lower bound of 50% and upper bound of 56% growth over the same period in the prior year - Gross margin for the full year 2023 expected to be in the range of 83% to 85%
Third Quarter 2023 Financial Results
Our commercial revenue, which excludes
Gross profit margin increased by 1.3% to 84.5% compared to 83.2% for the third quarter of 2022. The increase was largely driven by higher production associated with our increase in revenues and lower shipping costs.
Total operating expenses for the quarter were
Net loss was
As of
BARDA income consisted of funding from the
Webcast and Conference Call Information
The Company will host a conference call to discuss the third quarter financial results and, recent business highlights on
About
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 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
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
To learn more, visit www.avitamedical.com.
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:
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com
Authorized for release by the Chief Financial Officer of
Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) | ||||||||
As of | ||||||||
ASSETS | ||||||||
Cash and cash equivalents | $ | 50,854 | $ | 18,164 | ||||
Marketable securities | 9,264 | 61,178 | ||||||
Accounts receivable, net | 5,875 | 3,515 | ||||||
BARDA receivables | 201 | 898 | ||||||
Prepaids and other current assets | 3,356 | 1,578 | ||||||
Inventory | 4,377 | 2,125 | ||||||
Total current assets | 73,927 | 87,458 | ||||||
Marketable securities long-term | - | 6,930 | ||||||
Plant and equipment, net | 1,862 | 1,200 | ||||||
Operating lease right-of-use assets | 2,607 | 851 | ||||||
Corporate-owned life insurance ("COLI") asset | 1,923 | 1,238 | ||||||
Intangible assets, net | 459 | 465 | ||||||
Other long-term assets | 236 | 122 | ||||||
Total assets | $ | 81,014 | $ | 98,264 | ||||
LIABILITIES, NON-QUALIFIED DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS' EQUITY | ||||||||
Accounts payable and accrued liabilities | 3,019 | 3,002 | ||||||
Accrued wages and fringe benefits | 7,143 | 6,623 | ||||||
Current non-qualified deferred compensation liability | 333 | 78 | ||||||
Other current liabilities | 1,341 | 990 | ||||||
Total current liabilities | 11,836 | 10,693 | ||||||
Non-qualified deferred compensation liability | 3,361 | 1,270 | ||||||
Contract liabilities | 365 | 698 | ||||||
Operating lease liabilities, long term | 1,845 | 306 | ||||||
Total liabilities | 17,407 | 12,967 | ||||||
Non-qualified deferred compensation plan share awards | 629 | 557 | ||||||
Contingencies (Note 12) | ||||||||
Stockholders' equity: | ||||||||
Common stock, | 3 | 3 | ||||||
Preferred stock, | - | - | ||||||
Company common stock held by the non-qualified deferred compensation plan ("NQDC Plan") | (1,290 | ) | (127 | ) | ||||
Additional paid-in capital | 347,192 | 339,825 | ||||||
Accumulated other comprehensive income | 7,977 | 7,627 | ||||||
Accumulated deficit | (290,904 | ) | (262,588 | ) | ||||
Total stockholders' equity | 62,978 | 84,740 | ||||||
Total liabilities, non-qualified deferred compensation plan share awards and stockholders' equity | $ | 81,014 | $ | 98,264 |
Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) | ||||||||||||||||
Three-Months Ended | Nine-Months Ended | |||||||||||||||
Revenues | $ | 13,645 | $ | 9,092 | $ | 35,948 | $ | 24,966 | ||||||||
Cost of sales | (2,113 | ) | (1,530 | ) | (5,984 | ) | (4,694 | ) | ||||||||
Gross profit | 11,532 | 7,562 | 29,964 | 20,272 | ||||||||||||
BARDA income | 212 | 904 | 1,369 | 2,189 | ||||||||||||
Operating expenses: | ||||||||||||||||
Sales and marketing expenses | (10,532 | ) | (5,411 | ) | (27,075 | ) | (15,571 | ) | ||||||||
General and administrative expenses | (6,124 | ) | (5,004 | ) | (20,584 | ) | (18,009 | ) | ||||||||
Research and development expenses | (4,394 | ) | (3,799 | ) | (14,056 | ) | (10,478 | ) | ||||||||
Total operating expenses | (21,050 | ) | (14,214 | ) | (61,715 | ) | (44,058 | ) | ||||||||
Operating loss | (9,306 | ) | (5,748 | ) | (30,382 | ) | (21,597 | ) | ||||||||
Interest expense | (10 | ) | (6 | ) | (21 | ) | (10 | ) | ||||||||
Other income | 615 | 170 | 2,141 | 307 | ||||||||||||
Loss before income taxes | (8,701 | ) | (5,584 | ) | (28,262 | ) | (21,300 | ) | ||||||||
Income tax expense | (11 | ) | (4 | ) | (54 | ) | (12 | ) | ||||||||
Net loss | $ | (8,712 | ) | $ | (5,588 | ) | $ | (28,316 | ) | $ | (21,312 | ) | ||||
Net loss per common share: | ||||||||||||||||
Basic and Diluted | $ | (0.34 | ) | $ | (0.22 | ) | $ | (1.12 | ) | $ | (0.85 | ) | ||||
Weighted-average common shares: | ||||||||||||||||
Basic and Diluted | 25,401,754 | 25,006,995 | 25,281,920 | 24,972,331 |
Source:
2023 GlobeNewswire, Inc., source