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.
Authorized for release by the Chief Financial
Officer of AVITA Medical, Inc.
ABOUT AVITA Medical, Inc.
AVITA Medical, Inc. is a regenerative medicine company with a
technology platform positioned to address unmet medical needs in
burns, chronic wounds, and aesthetics indications. AVITA Medical
Inc. patented, and proprietary collection and application
technology provides innovative treatment solutions derived from the
regenerative properties of a patient’s own skin. The medical
devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION,
an autologous suspension comprised of the patient’s skin cells
necessary to regenerate natural healthy epidermis. This autologous
suspension is then sprayed onto the areas of the patient requiring
treatment.
AVITA Medicals’ 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. 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 8,000 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 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 a device that enables healthcare professionals to produce
a suspension of Spray-On Skin™ Cells using a small sample of the
patient’s own skin for the treatment of acute thermal burns
In international markets, our products are marketed under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, chronic wounds, and aesthetics. The
RECELL System is TGA-registered in Australia and received CE-mark
approval in Europe.
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 goals. 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 statement. Applicable risks and uncertainties
include, among others, the timing 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 including, but not
limited to the ongoing COVID-19 pandemic which are 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:
U.S. MediaSam Brown, Inc.Christy
CurranPhone +1 615 414 8668christycurran@sambrown.comO.U.S
MediaMonsoon CommunicationsRudi
MichelsonPhone +61 (0)3 9620 3333Mobile +61 (0)411 402
737rudim@monsoon.com.au |
InvestorsICR WestwickeCaroline
CornerPhone +1 415 202 5678caroline.corner@westwicke.com |
AVITA MEDICAL,
INC.Consolidated Balance
Sheets(In thousands, except share and per share
data)(Unaudited)
|
|
As of |
|
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
23,535 |
|
|
$ |
55,511 |
|
Marketable securities |
|
|
59,835 |
|
|
|
29,649 |
|
Accounts receivable, net |
|
|
3,481 |
|
|
|
3,118 |
|
BARDA receivables |
|
|
682 |
|
|
|
308 |
|
Prepaids and other current assets |
|
|
1,146 |
|
|
|
1,213 |
|
Restricted cash |
|
|
201 |
|
|
|
201 |
|
Inventory |
|
|
1,803 |
|
|
|
2,132 |
|
Total current assets |
|
|
90,683 |
|
|
|
92,132 |
|
Marketable securities, long-term |
|
|
11,684 |
|
|
|
19,692 |
|
Plant and equipment, net |
|
|
1,171 |
|
|
|
1,262 |
|
Operating lease right-of-use assets |
|
|
1,375 |
|
|
|
1,544 |
|
Intangible assets, net |
|
|
416 |
|
|
|
443 |
|
Other long-term assets |
|
|
1,162 |
|
|
|
942 |
|
Total
assets |
|
$ |
106,491 |
|
|
$ |
116,015 |
|
LIABILITIES AND
SHAREHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
2,397 |
|
|
|
2,708 |
|
Accrued wages and fringe benefits |
|
|
2,914 |
|
|
|
5,363 |
|
Other current liabilities |
|
|
1,186 |
|
|
|
1,075 |
|
Total current liabilities |
|
|
6,497 |
|
|
|
9,146 |
|
Contract liabilities |
|
|
882 |
|
|
|
952 |
|
Operating lease liabilities, long-term |
|
|
726 |
|
|
|
918 |
|
Other long-term liabilities |
|
|
571 |
|
|
|
375 |
|
Total liabilities |
|
|
8,676 |
|
|
|
11,391 |
|
Contingencies (Note 12) |
|
|
|
|
|
|
|
|
Shareholders' Equity: |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value per share, 200,000,000 shares
authorized, 24,955,581 and 24,925,743 shares issued and outstanding
at March 31, 2022 and December 31, 2021, respectively |
|
|
3 |
|
|
|
3 |
|
Preferred stock, $0.0001 par value per share, 10,000,000 shares
authorized, no shares issued or outstanding at March 31, 2022 and
December 31, 2021 |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
335,417 |
|
|
|
332,484 |
|
Accumulated other comprehensive income |
|
|
7,781 |
|
|
|
8,060 |
|
Accumulated deficit |
|
|
(245,386 |
) |
|
|
(235,923 |
) |
Total shareholders'
equity |
|
|
97,815 |
|
|
|
104,624 |
|
Total liabilities and
shareholders' equity |
|
$ |
106,491 |
|
|
$ |
116,015 |
|
AVITA MEDICAL,
INC.Consolidated Statements of
Operations(In thousands, except share and per
share data)(Unaudited)
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenues |
|
$ |
7,539 |
|
|
$ |
8,765 |
|
Cost of sales |
|
|
(1,778 |
) |
|
|
(2,146 |
) |
Gross profit |
|
|
5,761 |
|
|
|
6,619 |
|
BARDA income |
|
|
734 |
|
|
|
570 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Sales and marketing expenses * |
|
|
(4,828 |
) |
|
|
(3,649 |
) |
General and administrative expenses * |
|
|
(7,534 |
) |
|
|
(5,422 |
) |
Research and development expenses * |
|
|
(3,620 |
) |
|
|
(4,109 |
) |
Total operating expenses |
|
|
(15,982 |
) |
|
|
(13,180 |
) |
Operating loss |
|
|
(9,487 |
) |
|
|
(5,991 |
) |
Interest expense |
|
|
- |
|
|
|
(3 |
) |
Other income |
|
|
28 |
|
|
|
7 |
|
Loss before income taxes |
|
|
(9,459 |
) |
|
|
(5,987 |
) |
Income tax expense |
|
|
(4 |
) |
|
|
(10 |
) |
Net loss |
|
$ |
(9,463 |
) |
|
$ |
(5,997 |
) |
Net loss per common
share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.38 |
) |
|
$ |
(0.26 |
) |
Diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.26 |
) |
Weighted-average common
shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
24,937,999 |
|
|
|
22,734,335 |
|
Diluted |
|
|
24,937,999 |
|
|
|
22,734,335 |
|
* Total operating expenses include impact of share-based
compensation as follows:
|
|
Three-months ended March 31, |
|
|
2022 |
|
2021 |
Sales and marketing expenses |
|
$ |
329 |
|
$ |
238 |
General and administrative
expenses |
|
|
2,327 |
|
|
930 |
Research and development
expenses |
|
|
276 |
|
|
165 |
Total |
|
$ |
2,932 |
|
$ |
1,333 |
Reconciliation of reported Net Loss
(GAAP) to Adjusted EBIDTA (NON-GAAP) Measure –
Unaudited
|
Three months ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Net Loss |
$ |
(9,463 |
) |
|
$ |
(5,997 |
) |
Depreciation expense |
|
129 |
|
|
|
137 |
|
Patent Amortization |
|
34 |
|
|
|
30 |
|
Share-based expense |
|
2,932 |
|
|
|
1,333 |
|
Interest Expense |
|
- |
|
|
|
3 |
|
Income Tax Expense |
|
4 |
|
|
|
10 |
|
Adjusted EBITDA
(Non-GAAP) |
$ |
(6,364 |
) |
|
$ |
(4,484 |
) |
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Sep 2024 to Oct 2024
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Oct 2023 to Oct 2024