AVITA Medical, Inc. (NASDAQ: RCEL, ASX:AVH)
(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 second quarter of fiscal
year 2021, ended December 31, 2020.
Second Quarter Highlights
- Reported U.S based RECELL® revenue of $5.0 million in the
second quarter of 2021 ended December 31, 2020, a 62% increase over
the same quarter in the prior year
- Reported total global revenue of $5.1 million in the second
quarter of 2021 ended December 31, 2020, a 57% increase over the
same quarter in the prior year
- Commercial metrics:° Procedural volumes were 487 in the
second quarter of 2021 versus 496 in the prior quarter ended
September 30, 2020° Added 7 new accounts in the second
quarter 2021 for a total of 93 accounts
- Enrolled nine patients in the pivotal study assessing the use
of the RECELL® System to treat stable vitiligo
“I’m proud of our progress over the last quarter as we strive to
broaden the applications of our platform to serve patients both
within burns and beyond. With our burn center account base now
mostly built out, our sales team is poised and ready to drive
utilization as the pandemic abates and we regain access to
hospitals and patients,” said Dr. Mike Perry, AVITA Medical Chief
Executive Officer. “We have continued to make strong progress with
our vitiligo pivotal trial, seeing very encouraging interest and
enrollment trends, and we believe this could put us in a position
to file for FDA approval in 2022.”
Second Quarter 2021 Financial
ResultsTotal global revenue was $5.1 million in the second
quarter of 2021, compared to $3.3 million for the same quarter last
year and flat to the prior quarter ended September 30, 2020.
Gross margin was 84% for the second quarter of
2021, compared with 74% in the same quarter last year, driven
largely by the extension of our shelf-life along with lower
shipping costs and increased production.
Operating expenses were $10.4 million for the
second quarter of 2021, compared with $13.4 million in the same
quarter last year. The decrease was primarily attributable to lower
stock-based compensation along with lower legal costs, partially
offset by the ramping up of clinical trials for treatment of
vitiligo and pediatric scald injuries and other research and
developments costs to further expand the Company’s pipeline. Lower
stock-based compensation is as a result of a reversal for unvested
stock awards due to the resignation of an executive officer.
Net loss was $5.6 million for the second quarter
of 2021 and net loss per share was $0.26 on a weighted-average
basic and diluted share count of 21.6 million, compared to $10.5
million and a net loss per share of $0.53 on a weighted-average
basic and diluted share count of 19.9 million in the same period of
the prior year.
Cash was $59.8 million as of December 31,
2020.
Outlook and COVID-19Due to uncertainty
surrounding the COVID-19 pandemic, the Company will not provide
financial guidance at this time. Nearly half of the Company’s
revenues come from twenty accounts with physicians and hospitals.
These accounts are susceptible to the effects of COVID-19 and
COVID-19 restrictions. To the extent that COVID-19 or other factors
cause such physicians or hospitals to be unable to treat patients
or delay the treatment of patients using the RECELL System in a
particular quarter, or make patients unavailable because of
COVID-19, our revenues could be negatively affected. Due to these
uncertainties, providing guidance at this time is not feasible.
Webcast and Conference Call InformationThe
Company will host a conference call to discuss the second quarter
financial results after market close on Thursday, February 11, 2021
at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (being 8.30am
Australian Eastern Daylight Time on Friday, February 12, 2021). 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: 5047528. The live webinar can be accessed at
https://ir.avitamedical.com.
Authorized for release by the Chief Executive 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 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 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 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 MEDICAL, INC.
Consolidated Balance Sheets (In thousands,
except share and per share data)
(Unaudited)
|
|
|
|
As of |
|
December 31, 2020 |
|
June 30, 2020 |
|
|
|
ASSETS |
|
|
Cash |
$ |
59,765 |
|
$ |
73,639 |
|
Accounts receivable, net |
|
1,941 |
|
|
2,076 |
|
BARDA receivables |
|
440 |
|
|
356 |
|
Prepaids and other current assets |
|
814 |
|
|
990 |
|
Restricted cash |
|
201 |
|
|
201 |
|
Inventory |
|
2,289 |
|
|
1,125 |
|
|
|
|
Total current assets |
|
65,450 |
|
|
78,387 |
|
Plant and equipment, net |
|
1,488 |
|
|
1,363 |
|
Operating lease right-of-use
assets |
|
1,795 |
|
|
2,347 |
|
Intangible assets, net |
|
420 |
|
|
364 |
|
Other long-term assets |
|
152 |
|
|
1 |
|
Total assets |
$ |
69,305 |
|
$ |
82,462 |
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
Accounts payable and accrued liabilities |
$ |
2,793 |
|
$ |
4,333 |
|
Accrued wages and fringe benefits |
|
4,305 |
|
|
2,816 |
|
Other current liabilities |
|
775 |
|
|
560 |
|
|
|
|
Total current liabilities |
|
7,873 |
|
|
7,709 |
|
Contract liabilities |
|
596 |
|
|
435 |
|
Operating lease liabilities, long
term |
|
1,239 |
|
|
1,917 |
|
|
|
|
Total liabilities |
|
9,708 |
|
|
10,061 |
|
|
|
|
Contingencies (Note 10) |
|
|
Shareholders’ Equity: |
|
|
Common stock, $0.0001 par value
per share, 200,000,000 shares authorized, 21,625,058 and 21,467,912
shares issued and outstanding at December 31, 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 December 31, 2020 and June 30, 2020 |
|
- |
|
|
- |
|
Additional paid-in capital |
|
262,086 |
|
|
259,165 |
|
Accumulated other comprehensive
income |
|
8,289 |
|
|
8,146 |
|
Accumulated deficit |
|
(210,781 |
) |
|
(194,913 |
) |
|
|
|
Total shareholders’ equity |
|
59,597 |
|
|
72,401 |
|
|
|
|
Total liabilities and
shareholders’ equity |
$ |
69,305 |
|
$ |
82,462 |
|
|
|
|
|
|
|
AVITA MEDICAL, INC.
Consolidated Statements of Operations (In
thousands, except share and per share data)
(Unaudited)
|
Three months ended December 31, |
|
Six months ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues |
$ |
5,103 |
|
|
$ |
3,259 |
|
|
$ |
10,163 |
|
|
$ |
6,509 |
|
Cost of sales |
|
821 |
|
|
|
846 |
|
|
|
1,750 |
|
|
|
1,465 |
|
Gross profit |
|
4,282 |
|
|
|
2,413 |
|
|
|
8,413 |
|
|
|
5,044 |
|
BARDA income |
|
449 |
|
|
|
386 |
|
|
|
1,045 |
|
|
|
2,437 |
|
Operating expenses: |
|
|
|
|
|
|
|
Sales and marketing expenses |
|
3,600 |
|
|
|
3,972 |
|
|
|
6,865 |
|
|
|
7,071 |
|
General and administrative
expenses |
|
3,401 |
|
|
|
7,107 |
|
|
|
11,703 |
|
|
|
10,529 |
|
Research and development
expenses |
|
3,361 |
|
|
|
2,312 |
|
|
|
6,735 |
|
|
|
4,131 |
|
Total operating expenses |
|
10,362 |
|
|
|
13,391 |
|
|
|
25,303 |
|
|
|
21,731 |
|
Operating loss |
|
(5,631 |
) |
|
|
(10,592 |
) |
|
|
(15,845 |
) |
|
|
(14,250 |
) |
Interest expense |
|
3 |
|
|
|
9 |
|
|
|
10 |
|
|
|
20 |
|
Other income/(expense) |
|
4 |
|
|
|
99 |
|
|
|
8 |
|
|
|
202 |
|
Loss before income taxes |
|
(5,630 |
) |
|
|
(10,502 |
) |
|
|
(15,847 |
) |
|
|
(14,068 |
) |
Income tax expense |
|
11 |
|
|
|
- |
|
|
|
21 |
|
|
|
- |
|
Net loss |
$ |
(5,641 |
) |
|
$ |
(10,502 |
) |
|
$ |
(15,868 |
) |
|
$ |
(14,068 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.26 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.74 |
) |
|
$ |
(0.73 |
) |
Diluted |
$ |
(0.26 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.74 |
) |
|
$ |
(0.73 |
) |
Weighted-average common
shares: |
|
|
|
|
|
|
|
Basic |
|
21,623,509 |
|
|
|
19,877,676 |
|
|
|
21,563,576 |
|
|
|
19,298,767 |
|
Diluted |
|
21,623,509 |
|
|
|
19,877,676 |
|
|
|
21,563,576 |
|
|
|
19,298,767 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses include impact of share-based
compensation as follows:
|
|
Three Months Ended December 31, |
|
Six Months Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Sales and marketing expenses |
$ |
294 |
|
|
$ |
234 |
|
$ |
624 |
|
$ |
370 |
General and administrative
expenses |
|
(774 |
) |
|
|
2,549 |
|
|
1,992 |
|
|
2,900 |
Research and development
expenses |
|
134 |
|
|
|
120 |
|
|
304 |
|
|
305 |
Total |
$ |
(346 |
) |
|
$ |
2,903 |
|
$ |
2,920 |
|
$ |
3,575 |
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