AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), 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 fiscal first quarter of 2021, ended September 30,
2020.
First Quarter
Highlights
- Reported U.S based RECELL® revenue of $5.0 million in the first
quarter of 2021, a 59% increase over the same quarter prior
year
- Total global revenue of $5.1 million in the first quarter of
2021, a 56% increase over the same quarter prior year
- Commercial metrics:○ Procedural volumes were 496 in the
first quarter of 2021, an increase of 27.2% over the prior
quarter○ Added 9 new accounts in the first quarter 2021 for a
total of 86 accounts
- Enrolled first patient in the pivotal study assessing the use
of the RECELL® System to treat stable vitiligo
“We saw a very encouraging recovery in procedure volumes and new
account openings in our fiscal first quarter, and while we still
expect to see some impacts due to the pandemic, we think our sales
trajectory within burns is back on track,” said Dr. Mike Perry,
AVITA Therapeutics Chief Executive Officer. “Looking ahead, we are
driving forth our efforts to leverage the RECELL system in other
markets and have been particularly encouraged by the patient and
physician interest and enrollment levels we’ve experienced in our
vitiligo trial.”
First Quarter
2021 Financial ResultsRevenue was
$5.1 million in the first quarter of 2021, compared to $3.3 million
for the same quarter last year and $3.9 million for the prior
quarter.
Gross margin was 82% for the first quarter of
2021, compared with 81% in the same quarter last year.
Operating expenses were $14.9 million for the
first quarter of 2021, compared with $8.3 million in the same
quarter last year. The increase was primarily driven by the
additional costs of the Company’s status as a dual listed entity on
NASDAQ and the ASX, along with commencement of pivotal clinical
trials for the treatment of pediatric scald injuries, soft tissue
reconstruction, vitiligo and other research and development
activities to further promote the RECELL System.
Net loss was $10.2 million for the first quarter
of 2021 and net loss per share was $0.48 on a weighted-average
basic and diluted share count of 21.5 million, compared to $3.6
million and a net loss per share of $0.19 on a weighted-average
basic and diluted share count of 18.7 million in the same period of
the prior year.
Cash was $65.8 million as of September 30,
2020.
Outlook and COVID-19Due to uncertainty
surrounding the COVID-19 pandemic, AVITA Therapeutics will not
provide financial guidance at this time. Management will continue
to evaluate its guidance policies and anticipates providing an
update at the time of its second quarter earnings announcement, to
the extent practicable, based on available information at that
time.
Webcast and Conference Call InformationAVITA
Therapeutics will host a conference call to discuss the first
quarter financial results after market close on Tuesday, November
10, 2020 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The
conference call can be accessed live over the phone (833) 614-1538
for U.S. callers or (706) 634-6548 for international callers, using
conference ID: 2688929. The live webinar can be accessed at
https://ir.avitamedical.com.
Authorized for release by the Chief Executive Officer of AVITA
Therapeutics, Inc.
ABOUT AVITA THERAPEUTICS,
INC.AVITA Therapeutics is a regenerative medicine company
with a technology platform positioned to address unmet medical
needs in burns, chronic wounds, and aesthetics indications. AVITA
Therapeutics’ 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 Therapeutics’ 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 indicated for use in the
treatment of acute thermal burns in patients 18 years and older.
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 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.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTSThis letter 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 letter 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 letter 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 outside of the company’s control. Investors
should not place considerable reliance on the forward-looking
statements contained in this letter. 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 letter 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 |
InvestorsWestwicke
PartnersCaroline CornerPhone +1 415 202
5678caroline.corner@westwicke.com |
|
AVITA THERAPEUTICS, INC. |
Consolidated Statements of Operations |
(In thousands, except share and per share
data) |
|
|
|
|
|
Three months ended September 30, |
|
2020 |
|
2019 |
Revenues |
$ |
5,060 |
|
|
$ |
3,250 |
|
Cost of sales |
|
929 |
|
|
|
619 |
|
Gross profit |
|
4,131 |
|
|
|
2,631 |
|
BARDA income |
|
596 |
|
|
|
2,051 |
|
Operating expenses: |
|
|
|
Sales and marketing expenses |
|
2,935 |
|
|
|
2,962 |
|
General and administrative expenses |
|
5,536 |
|
|
|
3,071 |
|
Research and development expenses |
|
3,204 |
|
|
|
1,635 |
|
Share-based compensation |
|
3,266 |
|
|
|
672 |
|
Total operating expenses |
|
14,941 |
|
|
|
8,340 |
|
Operating loss |
|
(10,214 |
) |
|
|
(3,658 |
) |
Interest expense |
|
7 |
|
|
|
11 |
|
Other income |
|
4 |
|
|
|
103 |
|
Loss before income taxes |
|
(10,217 |
) |
|
|
(3,566 |
) |
Income tax expense |
|
10 |
|
|
|
- |
|
Net loss |
$ |
(10,227 |
) |
|
$ |
(3,566 |
) |
Net loss per common
share: |
|
|
|
Basic |
$ |
0.48 |
|
|
$ |
0.19 |
|
Diluted |
$ |
0.48 |
|
|
$ |
0.19 |
|
|
|
|
|
Weighted-average common
shares: |
|
|
|
Basic |
|
21,503,643 |
|
|
|
18,719,857 |
|
Diluted |
|
21,503,643 |
|
|
|
18,719,857 |
|
|
|
|
|
|
AVITA THERAPEUTICS, INC. |
Consolidated Balance Sheets |
(In thousands, except share and per share
data) |
|
|
|
|
|
As of |
|
September 30, 2020 |
|
June 30, 2020 |
ASSETS |
|
|
|
Cash |
$ |
65,753 |
|
|
$ |
73,639 |
|
Accounts receivable, net |
|
2,360 |
|
|
|
2,076 |
|
BARDA receivables |
|
371 |
|
|
|
356 |
|
Prepaids and other current assets |
|
1,054 |
|
|
|
990 |
|
Restricted cash |
|
201 |
|
|
|
201 |
|
Inventory |
|
1,657 |
|
|
|
1,125 |
|
Total current assets |
|
71,396 |
|
|
|
78,387 |
|
Plant and equipment, net |
|
1,349 |
|
|
|
1,363 |
|
Operating lease right-of-use
assets |
|
2,216 |
|
|
|
2,347 |
|
Intangible assets |
|
403 |
|
|
|
364 |
|
Other long term assets |
|
55 |
|
|
|
1 |
|
Total assets |
$ |
75,419 |
|
|
$ |
82,462 |
|
LIABILITIES AND
SHAREHOLDERS' EQUITY |
|
|
|
Accounts payable and accrued liabilities |
$ |
3,570 |
|
|
$ |
4,333 |
|
Accrued wages and fringe benefits |
|
3,589 |
|
|
|
2,816 |
|
Other current liabilities |
|
561 |
|
|
|
560 |
|
Total current liabilities |
|
7,720 |
|
|
|
7,709 |
|
Contract liabilities |
|
435 |
|
|
|
435 |
|
Operating lease liabilities,
long term |
|
1,776 |
|
|
|
1,917 |
|
Total liabilities |
|
9,931 |
|
|
|
10,061 |
|
Contingencies (Note 10) |
|
|
|
Shareholders' Equity: |
|
|
|
Common stock, $0.0001 par value
per share, 200,000,000 shares authorized, 21,623,287 and 21,467,912
shares issued and outstanding at September 30, 2020 and June 30,
2020, respectively |
|
3 |
|
|
|
3 |
|
Preferred stock, $0.0001 par
value per share, 10,000,000 shares authorized, no shares issued or
outstanding at September 30, 2020 and June 30, 2020 |
|
- |
|
|
|
- |
|
Additional paid-in
capital |
|
262,431 |
|
|
|
259,165 |
|
Accumulated other
comprehensive income |
|
8,194 |
|
|
|
8,146 |
|
Accumulated deficit |
|
(205,140 |
) |
|
|
(194,913 |
) |
Total shareholders'
equity |
|
65,488 |
|
|
|
72,401 |
|
Total liabilities and
shareholders' equity |
$ |
75,419 |
|
|
$ |
82,462 |
|
|
|
|
|
|
|
|
|
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