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 third quarter of fiscal year
2021, ended March 31, 2021.
Third Quarter Highlights
- Reported RECELL® revenue of $8.8 million in the third quarter
of 2021, a 126% increase over the same quarter in the prior
year.
- Commercial metrics:
- Procedural volumes were 492 in the third quarter of 2021,
compared with 408 in the same period last year, and 487 in the
prior quarter ended December 31, 2020;
- Added 6 new burn center accounts in the third quarter 2021 for
a total of 99 accounts, or a penetration rate of 73% of the 136
total U.S. burn centers;
- Of the approximate 300 total U.S. burn surgeons:
- 244 U.S. burn surgeons have been trained and certified with
RECELL® through the third quarter of 2021, for a penetration rate
of 81%; and
- 147 burn surgeons used RECELL® in the third quarter of 2021,
for a penetration rate of nearly 50%.
“We made steady progress over the last quarter as we continued
to drive RECELL® usage in our established hospital burn center base
with an increasing focus on smaller burns, and we continued to
expand our physician training and outreach programs. As pandemic
headwinds abate, we plan to leverage our highly experienced burns
sales force and strong relationships built to date with the burn
practitioner community to increase hospital access and to penetrate
deeper into our existing accounts, resulting in additional
procedures and engaging more burn practitioners,” said Dr. Mike
Perry, AVITA Medical Chief Executive Officer. “Our three pivotal
clinical trials in vitiligo, trauma, and pediatric burns are
continuing on schedule and we expect to see expanded indications
for RECELL® coming online, allowing us to serve an ever-growing
population of patients.”
Third Quarter 2021 Financial
ResultsRevenue in the third quarter ended March 31, 2021
was $8.8 million, compared to $3.9 million in the corresponding
period ended March 31, 2020, and compared to $5.1 million in the
prior quarter ended December 31, 2020. In the third quarter ended
March 2021, RECELL® commercial revenues were $4.6 million, while
RECELL® revenues associated with the U.S. Department of Health and
Human Services’ Biomedical Advanced Research and Development
Authority within the Office of the Assistant Secretary for
Preparedness and Response (“BARDA”) were $4.1 million. Revenues
associated with BARDA were attributable to the purchase of RECELL®
units for emergency preparedness by BARDA. RECELL® commercial
revenues in the third quarter ended March 31, 2021 compared to the
corresponding period ended March 31, 2020, increased $0.7 million,
or 19%.
Gross margin was 76% for the third quarter of
2021, compared with 84% in the same quarter last year. Lower third
quarter gross margins resulted from a lower RECELL® price point for
units that were purchased under contract with BARDA. AVITA’s
contract with BARDA was negotiated prior to the establishment of a
higher price point achieved in the RECELL® commercialization in the
United States.
Operating expenses were $13.2 million for the
third quarter of 2021, compared with $19.7 million in the same
quarter last year. The decrease in quarter over quarter expenses is
primarily attributable to lower stock-based compensation along with
lower sales and marketing expenses, partially offset by higher
costs in research and development. Lower stock-based compensation
was driven by higher share-based compensation expenses in the prior
year associated with certain performance milestones being met. The
decrease in sales and marketing expense in the current quarter is
primarily due to reduced travel to burn centers and industry
conferences necessitated by COVID-19 related travel restrictions,
partially offset by higher prior year costs incurred with the
RECELL® product launch. Higher research and development expenses
have resulted from a ramping up of clinical trial related
activities for treatment of vitiligo as well as other research and
developments costs to further expand the Company’s pipeline.
Net loss was $6.0 million for the third quarter
of 2021 and net loss per share was $0.26 on a weighted-average
basic and diluted share count of 22.7 million, compared to $15.0
million and a net loss per share of $0.71 on a weighted-average
basic and diluted share count of 21.2 million in the same period of
the prior year.
Cash was $114.9 million as of March 31, 2021,
which includes $64.0M net proceeds from our capital issuance closed
in the third quarter of 2021.
Fourth Quarter 2021 Revenue Guidance
- Total revenue expected to be in the range of $8.2-$8.6 million,
consisting of $5.0-5.3 million of commercial RECELL® revenue and
$3.2-3.3 million of RECELL® revenue associated with BARDA.
Webcast and Conference Call InformationThe
Company will host a conference call to discuss the third quarter
financial results after market close on Thursday, May 13, 2021 at
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (being 6.30 a.m.
Australian Eastern Daylight Time on Friday, May 14, 2021). The
conference call can be accessed live over the phone for (833)
614-1538 U.S. callers or for (706) 634-6548 international callers,
using conference ID:5490156. 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 Medical’s 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 |
|
March 31, 2021 |
|
June 30, 2020 |
ASSETS |
|
|
|
|
|
Cash |
$ |
114,879 |
|
|
$ |
73,639 |
|
Accounts receivable, net |
|
2,230 |
|
|
|
2,076 |
|
BARDA receivables |
|
3,250 |
|
|
|
356 |
|
Prepaids and other current assets |
|
1,357 |
|
|
|
990 |
|
Restricted cash |
|
201 |
|
|
|
201 |
|
Inventory |
|
1,794 |
|
|
|
1,125 |
|
Total current assets |
|
123,711 |
|
|
|
78,387 |
|
Plant and equipment, net |
|
1,643 |
|
|
|
1,363 |
|
Operating lease right-of-use
assets |
|
1,639 |
|
|
|
2,347 |
|
Intangible assets, net |
|
463 |
|
|
|
364 |
|
Other long-term assets |
|
631 |
|
|
|
1 |
|
Total assets |
$ |
128,087 |
|
|
$ |
82,462 |
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
Accounts payable and accrued liabilities |
$ |
3,638 |
|
|
$ |
4,333 |
|
Accrued wages and fringe benefits |
|
2,472 |
|
|
|
2,816 |
|
Other current liabilities |
|
956 |
|
|
|
560 |
|
Total current liabilities |
|
7,066 |
|
|
|
7,709 |
|
Contract liabilities |
|
999 |
|
|
|
435 |
|
Operating lease liabilities,
long term |
|
1,060 |
|
|
|
1,917 |
|
Other long-term
liabilities |
|
19 |
|
|
|
- |
|
Total liabilities |
|
9,144 |
|
|
|
10,061 |
|
Contingencies (Note 10) |
|
|
Shareholders’ Equity: |
|
|
Common stock, $0.0001 par
value per share, 200,000,000 shares authorized, 24,842,883 and
21,467,912 shares issued and outstanding at March 31, 2021 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 March 31, 2021 and June 30, 2020 |
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
327,447 |
|
|
|
259,165 |
|
Accumulated other
comprehensive income |
|
8,271 |
|
|
|
8,146 |
|
Accumulated deficit |
|
(216,778 |
) |
|
|
(194,913 |
) |
Total shareholders’
equity |
|
118,943 |
|
|
|
72,401 |
|
Total liabilities and
shareholders’ equity |
$ |
128,087 |
|
|
$ |
82,462 |
|
|
|
|
|
AVITA MEDICAL, INC. Consolidated
Statements of Operations (In thousands, except
share and per share data)
(Unaudited) |
|
|
|
|
|
|
|
Three months ended March 31, |
|
Nine months ended March 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenues |
$ |
8,765 |
|
|
$ |
3,877 |
|
|
$ |
18,928 |
|
|
$ |
10,386 |
|
Cost of sales |
|
(2,146 |
) |
|
|
(634 |
) |
|
|
(3,896 |
) |
|
|
(2,099 |
) |
Gross profit |
|
6,619 |
|
|
|
3,243 |
|
|
|
15,032 |
|
|
|
8,287 |
|
BARDA income |
|
570 |
|
|
|
1,008 |
|
|
|
1,615 |
|
|
|
3,445 |
|
Operating expenses: |
|
|
|
|
Sales and marketing
expenses(1) |
|
(3,649 |
) |
|
|
(4,375 |
) |
|
|
(10,514 |
) |
|
|
(11,446 |
) |
General and administrative
expenses(1) |
|
(5,422 |
) |
|
|
(12,787 |
) |
|
|
(17,125 |
) |
|
|
(23,316 |
) |
Research and development
expenses(1) |
|
(4,109 |
) |
|
|
(2,495 |
) |
|
|
(10,844 |
) |
|
|
(6,626 |
) |
Total operating expenses |
|
(13,180 |
) |
|
|
(19,657 |
) |
|
|
(38,483 |
) |
|
|
(41,338 |
) |
Operating loss |
|
(5,991 |
) |
|
|
(15,406 |
) |
|
|
(21,836 |
) |
|
|
(29,656 |
) |
Interest expense |
|
(3 |
) |
|
|
(5 |
) |
|
|
(13 |
) |
|
|
(25 |
) |
Other income/(expense) |
|
7 |
|
|
|
363 |
|
|
|
15 |
|
|
|
565 |
|
Loss before income taxes |
|
(5,987 |
) |
|
|
(15,048 |
) |
|
|
(21,834 |
) |
|
|
(29,116 |
) |
Income tax expense |
|
(10 |
) |
|
|
— |
|
|
|
(31 |
) |
|
|
— |
|
Net loss |
$ |
(5,997 |
) |
|
$ |
(15,048 |
) |
|
$ |
(21,865 |
) |
|
$ |
(29,116 |
) |
Net loss per common
share: |
|
|
|
|
Basic |
$ |
(0.26 |
) |
|
$ |
(0.71 |
) |
|
$ |
(1.00 |
) |
|
$ |
(1.46 |
) |
Diluted |
$ |
(0.26 |
) |
|
$ |
(0.71 |
) |
|
$ |
(1.00 |
) |
|
$ |
(1.46 |
) |
Weighted-average common
shares: |
|
|
|
|
Basic |
|
22,734,335 |
|
|
|
21,215,246 |
|
|
|
21,948,132 |
|
|
|
19,932,947 |
|
Diluted |
|
22,734,335 |
|
|
|
21,215,246 |
|
|
|
21,948,132 |
|
|
|
19,932,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses include impact of
share-based compensation as follows:
|
|
|
|
|
|
Three Months EndedMarch
31, |
|
Nine Months EndedMarch 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Sales and marketing expenses |
$ |
(238 |
) |
|
$ |
(214 |
) |
|
$ |
(862 |
) |
|
$ |
(584 |
) |
General and administrative
expenses |
|
(930 |
) |
|
|
(8,641 |
) |
|
|
(2,922 |
) |
|
|
(11,541 |
) |
Research and development
expenses |
|
(165 |
) |
|
|
(193 |
) |
|
|
(469 |
) |
|
|
(498 |
) |
|
|
|
|
|
Total |
$ |
(1,333 |
) |
|
$ |
(9,048 |
) |
|
$ |
(4,253 |
) |
|
$ |
(12,623 |
) |
|
|
|
|
|
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