AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage
regenerative medicine company focused on first-in-class devices for
wound care management and skin restoration, today reported
financial results for the second quarter ended June 30, 2024.
Financial Results and Recent Business
Updates
- Commercial revenue of $15.1 million, an increase of
approximately 29% compared to the same period in 2023
- Gross profit margin of 86.2%
- RECELL GO™ premarket approval (PMA) supplement approved by the
FDA on May 29, 2024; first case completed on May 31, 2024
- Submitted PMA supplement for RECELL GO mini™, designed to
address smaller wounds, on June 28, 2024; maintains Breakthrough
Device designation ensuring a prioritized 180-day interactive
review period
- Entered into an exclusive development and distribution
agreement with Regenity Biosciences ("Regenity") providing AVITA
Medical with the commercialization rights to a unique
collagen-based dermal matrix following 510(k) clearance
“Our second-quarter commercial revenue reached a record $15.1
million, reflecting the effectiveness of our enhanced focus on
commercial execution,” said Jim Corbett, Chief Executive Officer of
AVITA Medical. “The FDA approval of RECELL GO and our recent
submission of RECELL GO mini highlight our progress in expanding
treatment capabilities for burn and full-thickness skin defects.
Additionally, our agreement with Regenity further enhances our
ability to address a full spectrum of clinical needs. We remain
committed to establishing RECELL as the standard of care for wound
therapy while continuing to transform AVITA Medical into a
broad-based wound care company, ultimately improving accessibility
and reaching more patients.”
Future Milestones
- Expect Regenity to receive 510(k) clearance for the dermal
matrix in the fourth quarter of 2024; following clearance, AVITA
Medical will begin to market, sell, and distribute
- Plan to initiate multiple post-market clinical studies to
establish the unique synergies between the new dermal matrix and
RECELL
- Anticipate FDA approval of RECELL GO mini by December 27,
2024
- Expect to submit both our post-market study (TONE) treating
patients with stable vitiligo and separate health care economics
study for publication by year-end
Financial Guidance
- Commercial revenue for the third quarter 2024 is expected to be
in the range of $19.0 to $20.0 million, reflecting growth of
approximately 40% to 48% over the same period in 2023
- Commercial revenue for the full-year 2024 is now expected to be
in the range of $68.0 to $70.0 million, reflecting growth of
approximately 37% to 41% over the full-year 2023
- Expect to achieve previously given guidance of cashflow break
even and GAAP profitability no later than the end of the third
quarter of 2025
“We anticipate sequential third-quarter commercial revenue
growth between 26% to 32% over the second quarter,” said David
O'Toole, Chief Financial Officer of AVITA Medical. “Following our
solid second quarter and a strong start in July, we are confident
in our commercial team's ability to achieve this goal. However, we
have adjusted downward our full-year revenue guidance, which still
reflects a growth rate of over 37% year-over-year and our ongoing
growth trajectory. With positive new developments, including the
launch of RECELL GO and PermeaDerm, as well as the anticipated
launch of our new dermal matrix, we intend to build on our
second-quarter momentum and continue delivering strong
results.”
Second Quarter 2024 Financial Results
Total revenues increased by 29.3%, or $3.4 million, to $15.2
million, compared to $11.8 million in the same period in the prior
year. Our commercial revenue was $15.1 million in the three-months
ended June 30, 2024, an increase of $3.4 million, or 29.5%,
compared to $11.7 million in the corresponding period in the prior
year. The growth in commercial revenues was largely driven by
deeper penetration within existing customer accounts and new
accounts for full-thickness skin defect.
Gross profit margin was 86.2% compared to 81.2%, representing an
increase of 500 bps from the corresponding period in the prior
year. This was largely driven by increases in revenues and the
volume of production.
BARDA income decreased to zero, compared to $0.5 million in the
corresponding period in the prior year due to the ending of
reimbursable clinical trials. BARDA income in the prior year
consisted of funding from the Biomedical Advanced Research and
Development Authority, under the Assistant Secretary for
Preparedness and Response, within the U.S. Department of Health and
Human Services, under ongoing USG Contract No.
HHSO100201500028C.
Total operating expenses for the quarter were $28.7 million,
compared to $21.2 million in the same period in 2023. The increase
in operating expenses is primarily attributable to an increase of
$6.3 million in sales and marketing expenses due to
employee-related costs, including salaries and benefits,
commissions, professional fees, and travel expenses, collectively,
as a result of the expansion of our commercial organization to
support our growing commercial operations in the second quarter of
2023 and again in first quarter of 2024. G&A expenses increased
by $1.4 million as a result of higher salaries and benefits,
severance benefits, partially offset by lower deferred compensation
expenses and lower professional fees. In addition, operating
expenses were offset by a decrease of $0.2 million in R&D
costs, which was primarily due to a decrease in professional fees
and development expenses.
Interest expense increased approximately $1.3 million in
comparison to the same period in the prior year due to the interest
expense related to the long-term debt incurred as part of the
OrbiMed Credit Agreement, for a principal amount owed of $40.0
million.
Other income, net increased by $0.8 million to income of $1.6
million. In the current period other income consists of income of
$2.1 million related to the change in fair value of warrant
liability, $0.7 million in income related to our investments.
Income was offset by a non-cash charge of $1.2 million due to the
change in fair value of the debt. The prior period income consisted
of $0.7 million related to our investments and $0.1 million in
gains.
Net loss was $15.4 million, or a loss of $0.60 per basic and
diluted share, compared to a net loss of 10.4 million, or a loss of
$0.41 per basic and diluted share, in the same period in 2023.
As of June 30, 2024, the Company had approximately $54.1 million
in cash, cash equivalents, and marketable securities.
Webcast and Conference Call InformationAVITA
Medical will host a conference call on Thursday, August 8, 2024 at
1:30 p.m. Pacific Time (Friday, August 9, 2024, at 6:30 a.m.
Australian Eastern Standard Time) to discuss its financial results
and recent business highlights. To participate by telephone, please
register in advance to receive dial-in details and a personal PIN
at
https://register.vevent.com/register/BI460b032551fb410185009f5eac59ddac.
The live webcast will be accessible through the Events section of
AVITA Medical’s Investor Relations website at ir.avitamedical.com.
A replay of the webcast will be available shortly after the live
event.
About AVITA Medical, Inc.AVITA Medical® is a
commercial-stage regenerative medicine company transforming the
standard of care in wound care management and skin restoration with
innovative devices. At the forefront of our platform is the RECELL®
System, 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.
RECELL harnesses the regenerative properties of a patient’s own
skin to create Spray-On Skin™ Cells, delivering a transformative
solution at the point-of-care. This breakthrough technology serves
as the catalyst for a new treatment paradigm enabling improved
clinical outcomes. AVITA Medical also holds the exclusive rights to
market, sell, and distribute PermeaDerm®, a biosynthetic wound
matrix, in the United States.
In international markets, the RECELL System is approved 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, has received CE-mark approval in
Europe, and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This press release may contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements are subject to significant
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Forward-looking statements generally may 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,”
and similar words or expressions, and the use of future dates.
Forward-looking statements include, but are not limited to,
statements relating to 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. These statements are made as of the date of
this release, and the Company undertakes no obligation to publicly
update or revise any of these statements, except as required by
law. For additional information and other important factors that
may cause actual results to differ materially from forward-looking
statements, please see the “Risk Factors” section of the Company’s
latest Annual Report on Form 10-K and other publicly available
filings for a discussion of these and other risks and
uncertainties.
Authorized for release by the Chief Financial
Officer of AVITA Medical, Inc.
AVITA MEDICAL, INC.Consolidated Balance
Sheets(In thousands, except share and per share
data) |
|
|
|
As of |
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
17,452 |
|
|
$ |
22,118 |
|
Marketable securities |
|
|
36,604 |
|
|
|
66,939 |
|
Accounts receivable, net |
|
|
8,717 |
|
|
|
7,664 |
|
BARDA receivables |
|
|
94 |
|
|
|
30 |
|
Prepaids and other current assets |
|
|
3,382 |
|
|
|
1,659 |
|
Inventory |
|
|
6,709 |
|
|
|
5,596 |
|
Total current assets |
|
|
72,958 |
|
|
|
104,006 |
|
Plant and equipment, net |
|
|
7,024 |
|
|
|
1,877 |
|
Operating lease right-of-use assets |
|
|
3,938 |
|
|
|
2,440 |
|
Corporate-owned life insurance ("COLI") asset |
|
|
2,888 |
|
|
|
2,475 |
|
Intangible assets, net |
|
|
545 |
|
|
|
487 |
|
Other long-term assets |
|
|
473 |
|
|
|
355 |
|
Total assets |
|
$ |
87,826 |
|
|
$ |
111,640 |
|
LIABILITIES, NON-QUALIFIED
DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
4,155 |
|
|
|
3,793 |
|
Accrued wages and fringe benefits |
|
|
7,624 |
|
|
|
7,972 |
|
Current non-qualified deferred compensation ("NQDC") liability |
|
|
753 |
|
|
|
168 |
|
Other current liabilities |
|
|
1,255 |
|
|
|
1,266 |
|
Total current liabilities |
|
|
13,787 |
|
|
|
13,199 |
|
Long-term debt |
|
|
40,989 |
|
|
|
39,812 |
|
Non-qualified deferred compensation liability |
|
|
3,148 |
|
|
|
3,663 |
|
Contract liabilities |
|
|
340 |
|
|
|
357 |
|
Operating lease liabilities, long term |
|
|
3,281 |
|
|
|
1,702 |
|
Warrant liability |
|
|
1,968 |
|
|
|
3,158 |
|
Total liabilities |
|
|
63,513 |
|
|
|
61,891 |
|
Non-qualified deferred
compensation plan share awards |
|
|
398 |
|
|
|
693 |
|
Commitments and contingencies
(Note 13) |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value per share, 200,000,000 shares
authorized, 25,949,906 and 25,682,078, shares issued and
outstanding at June 30, 2024 and December 31, 2023,
respectively |
|
|
3 |
|
|
|
3 |
|
Preferred stock, $0.0001 par value per share, 10,000,000 shares
authorized, no shares issued or outstanding at June 30, 2024 and
December 31, 2023 |
|
|
- |
|
|
|
- |
|
Company common stock held by the non-qualified deferred
compensation plan |
|
|
(1,022 |
) |
|
|
(1,130 |
) |
Additional paid-in capital |
|
|
358,510 |
|
|
|
350,039 |
|
Accumulated other comprehensive loss |
|
|
(1,556 |
) |
|
|
(1,887 |
) |
Accumulated deficit |
|
|
(332,020 |
) |
|
|
(297,969 |
) |
Total stockholders'
equity |
|
|
23,915 |
|
|
|
49,056 |
|
Total liabilities,
non-qualified deferred compensation plan share awards and
stockholders' equity |
|
$ |
87,826 |
|
|
$ |
111,640 |
|
|
|
|
|
|
|
|
AVITA MEDICAL, INC.Consolidated Statements
of Operations(In thousands, except share and per
share data)(Unaudited) |
|
|
|
Three-Months Ended |
|
|
Six-Months Ended |
|
|
|
June 30, 2024 |
|
|
June 30, 2023 |
|
|
June 30, 2024 |
|
|
June 30, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales revenue |
|
$ |
15,183 |
|
|
$ |
11,753 |
|
|
$ |
26,287 |
|
|
$ |
22,303 |
|
Lease revenue |
|
|
12 |
|
|
|
- |
|
|
|
12 |
|
|
|
- |
|
Total revenues |
|
|
15,195 |
|
|
|
11,753 |
|
|
|
26,299 |
|
|
|
22,303 |
|
Cost of sales |
|
|
(2,111 |
) |
|
|
(2,204 |
) |
|
|
(3,624 |
) |
|
|
(3,871 |
) |
Gross profit |
|
|
13,084 |
|
|
|
9,549 |
|
|
|
22,675 |
|
|
|
18,432 |
|
BARDA income |
|
|
- |
|
|
|
530 |
|
|
|
- |
|
|
|
1,157 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
(16,302 |
) |
|
|
(10,003 |
) |
|
|
(28,942 |
) |
|
|
(16,543 |
) |
General and administrative |
|
|
(7,519 |
) |
|
|
(6,165 |
) |
|
|
(16,481 |
) |
|
|
(14,460 |
) |
Research and development |
|
|
(4,887 |
) |
|
|
(5,076 |
) |
|
|
(10,081 |
) |
|
|
(9,662 |
) |
Total operating expenses |
|
|
(28,708 |
) |
|
|
(21,244 |
) |
|
|
(55,504 |
) |
|
|
(40,665 |
) |
Operating loss |
|
|
(15,624 |
) |
|
|
(11,165 |
) |
|
|
(32,829 |
) |
|
|
(21,076 |
) |
Interest expense |
|
|
(1,347 |
) |
|
|
(7 |
) |
|
|
(2,703 |
) |
|
|
(11 |
) |
Other income, net |
|
|
1,611 |
|
|
|
801 |
|
|
|
1,544 |
|
|
|
1,526 |
|
Loss before income taxes |
|
|
(15,360 |
) |
|
|
(10,371 |
) |
|
|
(33,988 |
) |
|
|
(19,561 |
) |
Income tax expense |
|
|
(33 |
) |
|
|
(13 |
) |
|
|
(63 |
) |
|
|
(43 |
) |
Net loss |
|
$ |
(15,393 |
) |
|
$ |
(10,384 |
) |
|
$ |
(34,051 |
) |
|
$ |
(19,604 |
) |
Net loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.60 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.32 |
) |
|
$ |
(0.78 |
) |
Weighted-average common
shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
25,760,278 |
|
|
|
25,239,723 |
|
|
|
25,699,030 |
|
|
|
25,221,009 |
|
Investor & Media Contact:
Jessica Ekeberg
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com
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