- U.S. RECELL® System product sales of A$4.6M
for fiscal first quarter, 60% growth quarter-over-quarter
- Over half of all U.S. burn centers and
surgeons trained on RECELL System
AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine
company with a technology platform positioned to address unmet
medical needs in therapeutic skin restoration, reported financial
results for the fiscal first quarter ended 30 September 2019 today
in its Appendix 4C - Quarterly Cash Flow Report filed with the
ASX.
U.S. Commercial Sales of RECELL® System
The RECELL System has been actively promoted for nine months in
the United States following approval by the U.S. Food and Drug
Administration (FDA) on 20 September 2018, and the full nationwide
commercial launch in January 2019. Product sales and other revenues
for the first quarter ended 30 September 2019 were as follows
(unaudited):
Three Months Ended
(In thousands of AUD)
30 September
2019
2018
U.S. product sales
A$
4,583
A$
-
International product sales
176
368
Total product sales
4,759
368
Other revenue (including BARDA)
3,141
2,604
Total revenue
A$
7,900
A$
2,972
First Quarter Highlights
- A$4.6 million U.S. sales of RECELL System, 60% growth
quarter-over-quarter
- U.S. Commercial achievements since approval:
- 56 of 132 U.S. burn centers have placed orders for the RECELL
System
- Over 50% of U.S. burn surgeons and burn centers are trained on
the RECELL System
- A$10.8 million in U.S. sales
- Listed American Depositary Shares on the Nasdaq Capital Market
under the ticker symbol “RCEL,” with trading commencing 1
October
- AVITA Medical added to S&P/ASX300 index, which measures the
performance of the largest 300 companies based on market
capitalization on the Australian Securities Exchange
- Received U.S. FDA Investigational Device approval of pivotal
study protocol to evaluate the RECELL System for soft tissue
reconstruction, inclusive of traumatic wounds
- Publication of multiple studies in peer-reviewed medical
journals investigating the potential use of the RECELL System for
dermatological conditions:
- “The clinical efficacy of treatment using the autologous
non-cultured epidermal cell suspension technique for stable
vitiligo in 41 patients” by Bin Liu and Zhong-Hai Liu, Guangzhou
New Centre Institute of Vitiligo, Guangzhou, PR China, and Hui-Heng
Chen, Dongguan Eighth People’s Hospital & Dongguan Children’s
Hospital, Dongguan, PR China, et al. published online in the
Journal of Dermatological Treatmenti
- “The use of noncultured regenerative epithelial suspension for
improving skin color and scars: A report of eight cases and review
of the literature” by Jie Ren, PhD, M.D., and Jianlan Liu, PhD,
Department of Dermatology, Huashan Hospital, Fudan University,
Shanghai, China, et al. published in the Journal of Cosmetic
Dermatologyii
- “The clinical efficacy of RECELL autologous cell regeneration
techniques combined with dermabrasion treatment in acne scars” by
Qiao Chen, Nanze Yu, Zhifei Liu, et al. Department of Plastic
Surgery, Peking Union Medical College Hospital Chinese Academy of
Medical Sciences & Peking Union Medical College, Beijing,
China, published in Aesthetic Plastic Surgeryiii
- Health economics data demonstrating real-world cost savings and
reduced length of hospital stay for burn patients treated at Metro
Health Center in Cleveland, Ohio, with the RECELL System as
compared to the National Burn Repository data set presented at the
Eastern Great Lakes Regional Burn Conference 26-27 September 2019,
in Pittsburgh, Pennsylvania
“We are pleased with the substantial increase in quarterly sales
and the robust uptake of the RECELL System by U.S. burn surgeons
nine months into our commercial launch. Moreover, we are proud of
the impact this innovative technology is having on the advancement
of patient care,” said Dr. Mike Perry, AVITA Medical’s Chief
Executive Officer. “With our recent Nasdaq listing of American
Depositary Shares, we are providing broader access to investors and
we look forward to maintaining our growth trajectory by sustaining
a keen focus on U.S. commercial activities in tandem with growth of
our development pipeline.”
Recent Developments
AVITA Medical exhibited at the American Burn Association
National Burn Reconstruction Conference, 16-18 October 2019, in
Chicago; and RECELL System health economic and clinical data
demonstrating costs savings and efficacy is being presented by
physicians at four regional U.S. burn conferences this quarter.
RECELL clinical data will also be presented at the Congress of the
Asian Pacific Society for Scar Medicine with the Japan Scar
Workshop, 2-3 November 2019, in Tokyo.
Pipeline Update
In fiscal 2020, AVITA anticipates:
- Pivotal trials commencing to establish the safety and efficacy
of the RECELL System for early intervention treatment of pediatric
scald wounds and for soft tissue reconstruction and traumatic
wounds
- Pilot studies with the RECELL System for the treatment of
vitiligo with anticipation of advancing to pivotal clinical trials
in fiscal 2021
- Securing marketing approval and reimbursement for the RECELL
System in Japan in collaboration with COSMOTEC, an M3 Group
company
Funding and technical support for the development of the RECELL
System is provided by the Biomedical Advanced Research and
Development Authority (BARDA), under the Assistant Secretary for
Preparedness and Response, within the U.S. Department of Health and
Human Services, under ongoing USG Contract No. HHSO100201500028C.
Programs funded under the BARDA contract include two randomized,
controlled pivotal clinical trials, the Compassionate Use and
Continued Access programs, development of the health economic model
demonstrating the cost savings associated with the RECELL System,
and two randomized, controlled clinical trials in pediatric burn
patients.
First Quarter Fiscal 2020 Financial Results
(Unaudited)
(All amounts are in thousands of AUD except where noted)
A copy of the Appendix 4C - Quarterly Cash Flow Report for the
first quarter of fiscal 2020, the quarter ended 30 September 2019,
is attached. Operations for the quarter were focused primarily on
the U.S. national adoption of the RECELL System for the treatment
of acute thermal burns, and the preparation and implementation of
further clinical development of the RECELL System.
During the quarter ended 30 September 2019, total cash receipts
were A$5,237, an increase of A$197 or 4% compared to the prior
quarter ended 30 June 2019. Cash receipts from customers for the
quarter ended 30 September 2019 were A$4,079, an increase of A$565
or 16% compared to the prior quarter due to increased sales in the
U.S. Cash received from BARDA during the current quarter totalled
A$1,158, a decrease of A$368 or 24% compared to the prior quarter.
The decrease was the result of wind-down of certain activities
associated with supporting the U.S. FDA approval of the RECELL
System as well as Compassionate Use and Continued Access programs.
Through 30 September 2019, cumulative payments of A$27.9 million
have been received under the BARDA contract.
Overall payments for operating expenses decreased during the
first quarter of fiscal 2020 as a result of the timing of planned
initiatives set forth by the Company. During the quarter ended 30
September 2019, payments related to sales and marketing, staffing,
administrative and corporate costs for the current quarter totalled
A$9,535, a A$3,491 or 27% decrease compared to the quarter ended 30
June 2019 driven by the timing of planned initiatives. During the
quarter ended 30 September 2019, payments related to product
manufacturing and operating costs totalled A$1,344, a A$308 or 30%
increase compared to the quarter ended 30 June 2019. The increase
was directly related to the increase in sales during the current
quarter. During the quarter ended 30 September 2019, payments for
research and development costs totalled A$1,300, a A$129 or 9%
decrease compared to the quarter ended 30 June 2019. The decrease
was a result of the timing of research and development initiatives
as well as the Compassionate Use and Continued Access programs. As
a result of the national launch of the RECELL System in the U.S. in
January 2019, payments for operating expenses are expected to
increase in future quarters. These expense payments are expected to
be partially offset by receipts from customers and receipts under
the BARDA contract.
Total net cash used in operating activities during the quarter
ended 30 September 2019 was A$7,037, a A$3,393 or 33% decrease
compared to the quarter ended 30 June 2019 driven primarily by
timing of planned initiatives. Cash and cash equivalents held at 30
September 2019 was A$22,656.
Future cash requirements will be dependent upon the success of
AVITA Medical’s efforts to commercialize the RECELL System,
particularly in the U.S., and the timing and magnitude of clinical
and other research and development programs the Company elects to
undertake to expand its product pipeline. Until such time that the
Company generates sufficient cash flow from operations, it expects
to fund its future cash requirements through a combination of
current cash resources, and potentially the issuance of shares and
debt financing.
ABOUT AVITA MEDICAL LIMITED
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 REGENERATIVE EPIDERMAL SUSPENSION™
(RES™), 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 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.
i Bin Liu, Hui-Heng Chen, Zhong-Hai Liu, Jing-Feng Liang, Ru-Jun
Xue, Ping-Jiao Chen, Chang-Xing Li, Xiao-Dong Liang, Jie Deng,
Rui-Xian Ye, Xi- Bao Zhang & Jing-Yao Liang (2019) The clinical
efficacy of treatment using the autologous non-cultured epidermal
cell suspension technique for stable vitiligo in 41 patients,
Journal of Dermatological Treatment, DOI:
10.1080/09546634.2019.1619657 ii Ren J, Liu J, Yu N, et al. The use
of noncultured regenerative epithelial suspension for improving
skin color and scars: A report of 8 cases and review of the
literature. J Cosmet Dermatol. 2019;00:1–8.
https://doi.org/10.1111/jocd.13071 iii Chen, Q., Yu, N., Liu, Z. et
al. Aesth Plast Surg (2019).
https://doi.org/10.1007/s00266-019-01481-8
Appendix 4C Quarterly Report for entities
subject to Listing Rule 4.7B
+Rule 4.7B
Appendix 4C Quarterly Report for entities
subject to Listing Rule 4.7B
Introduced 31/03/00 Amended 30/09/01, 24/10/05,
17/12/10, 01/09/16
Name of entity
AVITA Medical Limited
ABN
Quarter Ended ("current
quarter")
28 058 466 523
30 September 2019
Consolidated statement of cash
flows
Current quarter
$A’000
Year to date
(3 months)
$A’000
1.
Cash flows from operating
activities
1.1
Receipts from customers
4,079
4,079
1.1a
Receipts from government contract
(BARDA)
1,158
1,158
1.2
Payments for
(a) research and development
(1,300
)
(1,300
)
(b) product manufacturing and operating
costs
(1,344
)
(1,344
)
(c) advertising and marketing
(2,257
)
(2,257
)
(d) leased assets
(246
)
(246
)
(e) staff costs
(5,097
)
(5,097
)
(f) administration and corporate costs
(2,181
)
(2,181
)
1.3
Dividends received
-
-
1.4
Interest received
151
151
1.5
Interest and other costs of finance
paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
-
1.8
Other (provide details if material)
-
-
1.9
Net cash used in operating
activities
(7,037
)
(7,037
)
Consolidated statement of cash
flows
Current quarter
$A’000
Year to date
(3 months)
$A’000
2.
Cash flows from investing
activities
2.1
Payments to acquire:
(a) property, plant and equipment
(203
)
(203
)
(b) businesses (see item 10)
-
-
(c) investments
-
-
(d) intellectual property
(97
)
(97
)
(e) other non-current assets
-
-
2.2
Proceeds from disposal of:
(a) property, plant and equipment
(b) businesses (see item 10)
-
-
(c) investments
-
-
(d) intellectual property
-
-
(e) other non-current assets
-
-
2.3
Cash flows from loans to other
entities
-
-
2.4
Dividends received (see note 3)
-
-
2.5
Other (provide details if material)
-
-
2.6
Net cash used in investing
activities
(300
)
(300
)
3.
Cash flows from financing
activities
3.1
Proceeds from issues of shares
-
-
3.2
Proceeds from issue of convertible
notes
-
-
3.3
Proceeds from exercise of share
options
-
-
3.4
Transaction costs related to issues of
shares, convertible notes or options
-
-
3.5
Proceeds from borrowings
-
-
3.6
Repayment of borrowings
-
-
3.7
Transaction costs related to loans and
borrowings
-
-
3.8
Dividends paid
-
-
3.9
Other (provide details if material)
-
-
3.10
Net cash from financing
activities
-
-
Consolidated statement of cash
flows
Current quarter
$A’000
Year to date
(3 months)
$A’000
4.
Net increase in cash and cash
equivalents for the period
4.1
Cash and cash equivalents at beginning of
quarter/year to date
28,983
28,983
4.2
Net cash used in operating activities
(item 1.9 above)
(7,037
)
(7,037
)
4.3
Net cash from used in investing activities
(item 2.6 above)
(300
)
(300
)
4.4
Net cash from financing activities (item
3.10 above)
-
-
4.5
Effect of movement in exchange rates on
cash held
1,010
1,010
4.6
Cash and cash equivalents at end of
quarter
22,656
22,656
5.
Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the related items in the
accounts
Current quarter
$A’000
Previous quarter
$A’000
5.1
Bank balances
22,656
28,983
5.2
Call deposits
-
-
5.3
Bank overdrafts
-
-
5.4
Other (provide details)
-
-
5.5
Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
22,656
28,983
6.
Payments to directors of the entity and
their associates
Current quarter
$A'000
6.1
Aggregate amount of payments to these
parties included in item 1.2
(291
)
6.2
Aggregate amount of cash flow from loans
to these parties included in item 2.3
6.3
Include below any explanation necessary to
understand the transactions included in items 6.1 and 6.2
6.1 Executive Director remuneration
(170k), Directors fees (81k), Clinical Advisory Board fees (11k),
and Bioscience Consultancy (29k).
7.
Payments to related entities of the
entity and their associates
Current quarter
$A'000
7.1
Aggregate amount of payments to these
parties included in item 1.2
7.2
Aggregate amount of cash flow from loans
to these parties included in item 2.3
7.3
Include below any explanation necessary to
understand the transactions included in items 7.1 and 7.2
8.
Financing facilities available
Add notes as necessary for an
understanding of the position
Total facility amount
at quarter end
$A’000
Amount drawn at
quarter end
$A’000
8.1
Loan facilities
8.2
Credit standby arrangements
8.3
Other (please specify)
8.4
Include below a description of each
facility above, including the lender, interest rate and whether it
is secured or unsecured. If any additional facilities have been
entered into or are proposed to be entered into after quarter end,
include details of those facilities as well.
9.
Estimated cash outflows for next
quarter
$A’000
9.1
Research and development
1,600
9.2
Product manufacturing and operating
costs
1,400
9.3
Advertising and marketing
2,400
9.4
Leased assets
250
9.5
Staff costs
5,200
9.6
Administration and corporate costs
2,100
9.7
Other (provide details if material)
-
9.8
Total estimated cash outflows*
12,950
* Pertains to outflows only, inflows from customer receipts and
government contracts, which totalled $5,237 for the quarter ended
30 September 2019 and are expected to increase in future quarters,
are not included.
10.
Acquisitions and disposals of business
entities
(items 2.1(b) and 2.2(b) above)
Acquisitions
Disposals
10.1
Name of entity
10.2
Place of incorporation or registration
10.3
Consideration for acquisition or
disposal
10.4
Total net assets
10.5
Nature of business
Compliance statement
- This statement has been prepared in accordance with accounting
standards and policies which comply with Listing Rule 19.11A.
- This statement gives a true and fair view of the matters
disclosed.
Timothy Rooney Timothy Rooney Chief Administrative Officer
and Interim Chief Financial Officer 31 October 2019
Notes
- The quarterly report provides a basis for informing the market
how the entity’s activities have been financed for the past quarter
and the effect on its cash position. An entity that wishes to
disclose additional information is encouraged to do so, in a note
or notes included in or attached to this report.
- If this quarterly report has been prepared in accordance with
Australian Accounting Standards, the definitions in, and provisions
of, AASB 107: Statement of Cash Flows apply to this report. If this
quarterly report has been prepared in accordance with other
accounting standards agreed by ASX pursuant to Listing Rule 19.11A,
the corresponding equivalent standard applies to this report.
- Dividends received may be classified either as cash flows from
operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
+ See chapter 19 for defined terms 1 September 2019
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191030006198/en/
U.S. Media Sam Brown, Inc. Christy Curran Phone +1
615 414 8668 christycurran@sambrown.com
O.U.S. Media Monsoon Communications Rudi Michelson
Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737
rudim@monsoon.com.au
Investors: Westwicke Partners Caroline Corner
Phone +1 415 202 5678 caroline.corner@westwicke.com
AVITA Medical Ltd Timothy Rooney Chief Administrative
Officer and Interim Chief Financial Officer Phone +1 661 367 9161
trooney@avitamedical.com
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