AVITA Medical Announces Preliminary Fiscal Second Quarter 2021 Results
January 12 2021 - 8:00AM
AVITA Medical, 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 announced preliminary
unaudited estimates of its top line results for the three months
ended December 31, 2020.
Preliminary Fiscal Second Quarter Estimates
- U.S based RECELL® revenue is expected to be $5.0 million in the
second quarter of 2021 ended December 31, 2020, compared to $5.0
million in the previous quarter. U.S based RECELL revenue increased
$1.9 million or 62% over the same quarter in the prior year.
- Total global revenue is expected to be $5.1 million in the
second quarter of 2021, compared to $5.1 million in the previous
quarter. Total global revenue increased $1.8 million in the current
quarter or 57% over the same quarter in the prior year.
- The Company had cash of approximately $59.8 million, a decrease
of $6.0 million or 9% over the $65.8 million held at the end of the
previous quarter.
Commercial Metrics:
- Enrolled 9 additional patients in the pivotal study assessing
the use of the RECELL System to treat stable vitiligo.
- Added 7 new accounts in the second quarter 2021 for a total of
93 accounts.
- Estimated procedural volumes were 485 in the second quarter of
2021, compared to 496 in the previous quarter.
“I’m pleased with our team’s commercial execution during these
challenging times,” said Dr. Mike Perry, AVITA Medical Chief
Executive Officer. “We continue to make solid progress on our
pipeline initiatives, and I look forward to updating you further
during our quarterly earnings call.”
The Company is providing the above information in advance of its
participation in the 39th Annual J.P. Morgan Health Conference,
which begins on Monday, January 11, 2021. The Company will post its
conference presentation to the ASX Market Announcements Platform
and will also make that presentation available on its website at
www.avitamedical.com/investors.
Authorized for release by the Chief Executive Officer of AVITA
Medical, Inc.
Financial Measures and other Items
The foregoing information and estimates are preliminary in
nature and are subject to revisions as we prepare our Form 10-Q
Quarterly Report for the second quarter ended December 31, 2020.
Because we have not completed our normal quarterly closing and
review procedures for the six months ended December 31, 2020, and
subsequent events may occur that require material adjustments to
these results, the final results and other disclosures for the
period may differ materially from these estimates. These estimates
should not be viewed as a substitute for the full disclosure of our
Form 10-Q Quarterly Report. These estimated results should be read
together with subsequent filings and announcements, including any
subsequent press release announcing the Company’s earnings for the
second quarter ended December 31, 2020.
Non-U.S. GAAP Financial Measures and Other Items
We use the following measures of financial performance which are
not presented in accordance with U.S. GAAP:
- “U.S. based RECELL Sales”, which is the amount of revenue
denominated in United States dollars, we generate from our
commercial efforts in relation to the sale of RECELL Systems within
the United states. Management believes that this measurement is
useful for comparing period to period sales performance, and
product acceptance of the Company’s lead product, the RECELL
System, within the United States burn market.
U.S. base RECELL Sales is a non-GAAP financial measure used by
management in evaluating sales performance, and product acceptance,
within the United States and for the purposes of making strategic
decisions. Management believes that the presentation of U.S. base
RECELL sales provides useful information to investors regarding our
revenue results because they assist both investors and management
in analyzing and benchmarking the performance and value of our
business. U.S. RECELL Sales provides indicators of product
performance that are not affected by currency fluctuations.
Accordingly, management believes that this measurement is useful
for comparing general sales performance from period to period in
the Company’s largest market.
ABOUT AVITA MEDICAL, INC.AVITA Medical is a
regenerative medicine company with a technology platform positioned
to address unmet medical needs in burns, chronic wounds, and
aesthetics indications. AVITA Medical’s 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 10,000 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
STATEMENTS This 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.
This press release was authorized by the review committee of
AVITA Medical, Inc.
FOR FURTHER INFORMATION:
U.S. MediaSam Brown, Inc.Christy CurranPhone
+1-615-414-8668christycurran@sambrown.comO.U.S.
MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61
(0)411 402 737 rudim@monsoon.com.au |
InvestorsWestwicke PartnersCaroline CornerPhone
+1-415-202-5678 caroline.corner@westwicke.com |
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