- Total revenue of A$17.0 million for fiscal year 2019 (FY19), an
increase of 50% year-over-year
- U.S. product sales of A$6.2 million for FY19
- U.S. product sales of A$2.9 million for fourth quarter, an
increase of 32% compared to FY third quarter sales
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, announced that it filed today with the ASX its
Appendix 4C - Quarterly Cash Flow Report for the quarter ended 30
June 2019, the fourth quarter of its fiscal 2019.
Provided below is an update regarding the substantial
accomplishments achieved during the quarter and full fiscal
year.
U.S. Commercial Sales of RECELL® System
AVITA began fulfilling orders within three weeks of the
September 20, 2018 FDA approval in a pre-launch phase prior to the
full nationwide launch which commenced in January 2019. The fourth
quarter represents the second quarter of active promotion of the
product. Product sales and other revenues for the fourth quarter
and fiscal year ended 30 June 2019 were as follows (unaudited):
Three Months Ended
Year Ended
(In thousands of AUD)
30 June
30 June
2019
2018
2019
2018
U.S. product sales
A$
2,867
A$
-
A$
6,215
A$
-
International product sales
591
354
1,490
1,199
Total product sales
3,458
354
7,705
1,199
Other revenue (including BARDA)
1,781
4,766
9,321
10,173
Total revenue
A$
5,239
A$
5,120
A$
17,026
A$
11,372
Fourth Quarter Highlights
- A$2.9 million U.S. sales of the RECELL System, 32% sequential
quarterly growth and 100% growth year-over-year
- U.S. commercial achievements to date:
- 41 of 134 U.S. burn centers have ordered RECELL
- 136 of 300 burn surgeons at 59 of the 134 U.S. burn centers
have been trained and have performed a RECELL procedure
- RECELL has a 100% success rate for hospital purchasing approval
(U.S. Value Analysis Committee or “VAC”)
- Clinical and cost-savings advantages of using the RECELL System
for the treatment of severe burns in broad range of patient
populations and burn types highlighted during 10 presentations at
the American Burn Association (ABA) 51st Annual Meeting 2-5 April
2019, in Las Vegas, Nevada.
- Published health economic model in Advances in Therapy
demonstrating reduced cost and decreased hospital stay with the
RECELL System. Utilizing this model, health economic data projects
that use the RECELL System to treat in-patient burns could save a
major U.S. burn center up to US$28 million annually, approximately
14 to 17% of their overall costs, compared to treatment with the
standard of care.i
- A$0.6 million international product sales for fourth quarter
(FY19), 100% sequential quarterly growth. On 12 June 2019, the
notified body responsible for EU certificates closed all open
administrative and procedural non-conformities previously announced
on 4 March 2019, and fully reinstated AVITA’s EU certificates,
allowing the resumption of sales throughout the EU.
- Presentations and publications on RECELL System studies
highlighted the potential use of the RECELL System in regenerative
dermatology and wound healing:
- Preliminary data for treatment of vitiligo and facial acne
scars presented at World Congress of Dermatology 10-15 June 2019 in
Milan, Italy
- Feasibility study results presented at 11th annual meeting of
the Japanese Society of Limb Salvage & Podiatric Medicine 28-29
June 2019 in Kobe, Japan, demonstrated that use of the RECELL
System reduced size of wounds caused by diabetic foot ulcers in all
participants
- Publication in the Journal of Dermatological Treatment of
favorable results, particularly in pediatric patients, from a
retrospective study of before-and-after comparisons exploring the
use of the RECELL System in the treatment of patients with stable
vitiligoii
Full Year Highlights
- A$17.0 million total revenue, 50% growth year-over-year.
(RECELL was launched in the U.S. in the second half of the fiscal
year 2019)
- Received U.S. Food and Drug Administration (FDA) approval of
the RECELL System in September 2018 for treatment of acute thermal
burns
- Attained reimbursement coding guidelines (from ABA), issued
within one week of FDA approval
- First commercial order received within three weeks of FDA
approval
- U.S. field force completely in place within 8 weeks of FDA
approval
- U.S. commercial launch in January 2019
- Expansion of manufacturing capabilities to support U.S. launch
of the RECELL System
- Executed collaboration agreement with COSMOTEC, an M3 Group
company, and application to market the RECELL System in Japan was
submitted for review
- Commenced enrollment in the U.S. Pediatric Donor Site
Study
- Presented and published RECELL System data:
- 50+ RECELL System presentations at more than 15 medical
conferences
- Pivotal trial results demonstrating safety and effectiveness of
the RECELL System in the treatment of second-iii and third-degree
burnsiv published and presented at ABA Annual meeting
“We view AVITA’s financial performance for the year as a
tremendous success, driven largely by the strong uptake of the
RECELL System by U.S. burn centers that have been quick to adopt
this innovative technology,” said Dr. Michael Perry, AVITA
Medical’s Chief Executive Officer. “This positive growth momentum
will continue in the next year with the anticipated expansion into
the Japanese market and advancement of our clinical pipeline in
additional high-value indications.”
Recent Developments
On 19 July 2019, AVITA submitted a confidential draft
registration statement on Form 20-F under the Securities Exchange
Act of 1934 to the Securities and Exchange Commission relating to
the proposed registration in the United States of its class of
American Depositary Shares (ADS) representing ordinary shares of
the Company. This disclosure does not constitute an offer to sell,
or the solicitation of an offer to buy, any securities of the
Company. In connection with the registration of such class of
securities, the Company intends to apply for listing on NASDAQ.
Should such listing be approved, our ADS would trade on NASDAQ and
would no longer trade on the over-the-counter market. There is no
guarantee that the Company’s efforts will be successful and the
Company may abandon its efforts to register this class of shares
and the NASDAQ application at any time at its sole discretion.
Pipeline Update
In fiscal 2020, AVITA anticipates pivotal trials commencing to
establish the safety and effectiveness of the RECELL System for
early intervention treatment of pediatric scald wounds and for
trauma/soft tissue repair. In fiscal 2021, AVITA expects to
commence a pivotal study of the RECELL System for the treatment of
vitiligo and anticipates, in collaboration with COSMOTEC, an M3
Group company, securing marketing approval and reimbursement of the
RECELL System in Japan.
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.
Fourth Quarter Fiscal 2019 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
fourth quarter of fiscal 2019, the quarter ended 30 June 2019, is
attached. Operations for the quarter were focused primarily on the
U.S. national market launch 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 June 2019, total cash receipts were
A$5,040, an increase of A$192 or 4% compared to the prior quarter
ended 31 March 2019. Cash receipts from customers for the quarter
ended 30 June 2019 were A$3,514, an increase of A$1,001 or 40%
compared to the prior quarter due to the second quarter
commencement of the U.S. national market launch of the RECELL
System. Cash received from BARDA during the current quarter totaled
A$1,526, a decrease of A$198 or 11% 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 June 2019, cumulative payments of A$25.9 million have
been received under the BARDA contract.
Overall payments for operating expenses increased in line with
expectations during the fourth quarter of fiscal 2019 as a result
of increased initiatives. During the quarter ended 30 June 2019,
payments related to sales and marketing, staffing, administrative
and corporate costs for the current quarter totaled A$13,265, a
A$3,687 or 38% increase compared to the quarter ended 31 March
2019. During the quarter ended 30 June 2019, payments related to
product manufacturing and operating costs totaled A$1,036, a A$117
or 13% increase compared to the quarter ended 31 March 2019. The
increase was directly related to the increase in sales during the
current quarter. During the quarter ended 30 June 2019, payments
for research and development costs totaled A$1,429, a A$504 or 54%
increase compared to the quarter ended 31 March 2019. This increase
was the result of the expansion of research and development 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 will increase in future
quarters. These expense payments will 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 June 2019 was A$10,430, a A$3,949 or 61% increase compared
to the quarter ended 31 March 2019. The current quarter increase in
net cash used in operating activities resulted from the increase in
payments for operating expenses, partially offset by cash
receipts.
During the quarter ended 30 June 2019, net proceeds provided by
employee stock options exercised was A$453. Cash and cash
equivalents held at 30 June 2019 was A$29,155.
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 a 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 outside of Europe, 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,
CFDA-cleared in China, 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 Kowal S, Kruger E, Bilir P, Holmes JH, Hickerson W, Foster K,
Nystrom S, Sparks J, Iyer N, Bush K, Quick A. Cost-Effectiveness of
the Use of Autologous Cell Harvesting Device Compared to Standard
of Care for Treatment of Severe Burns in the United States.
Advances in therapy. 2019. 36: 1715-1729.
https://doi.org/10.1007/s12325-019-00961-2 ii Liu B, Chen HH, Liu
ZH, Liang JF, Xue RJ, Chen PJ, Li CX, Liang XD, Deng J, Ye RX,
Zhang XB. The clinical efficacy of treatment using the autologous
non-cultured epidermal cell suspension technique for stable
vitiligo in 41 patients. Journal of Dermatological Treatment. 2019.
(accepted). https://doi.org/10.1080/09546634.2019.1619657 iii
Holmes IV JH, Molnar JA, Carter JE, Hwang J, Cairns BA, King BT,
Smith DJ, Cruse CW, Foster KN, Peck MD, Sood R. A comparative study
of the ReCell® device and autologous split-thickness meshed skin
graft in the treatment of acute burn injuries. Journal of Burn Care
& Research. 2018. 39(5): 694-702.
https://doi.org/10.1093/jbcr/iry029 iv Holmes IV JH, Molnar JA,
Shupp JW, Hickerson WL, King BT, Foster KN, Cairns BA, Carter JE.
Demonstration of the safety and effectiveness of the RECELL® System
combined with split-thickness meshed autografts for the reduction
of donor skin to treat mixed-depth burn injuries. Burns. 2019.
45(4): 772-782. https://doi.org/10.1016/j.burns.2018.11.002
+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 June 2019
Consolidated statement of cash
flows
Current quarter
$A’000
Year to date
(12 months)
$A’000
1.
Cash flows from operating
activities
1.1
Receipts from customers
3,514
7,232
1.1a
Receipts from government contract
(BARDA)
1,526
9,354
1.2
Payments for
(a) research and development
(1,429
)
(5,449
)
(b) product manufacturing and operating
costs
(1,036
)
(3,334
)
(c) advertising and marketing
(3,465
)
(9,727
)
(d) leased assets
(239
)
(1,016
)
(e) staff costs
(7,414
)
(19,362
)
(f) administration and corporate costs
(2,147
)
(8,514
)
1.3
Dividends received
-
-
1.4
Interest received
260
450
1.5
Interest and other costs of finance
paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
2,441
1.8
Other (provide details if material)
-
611
1.9
Net cash used in operating
activities
(10,430
)
(27,314
)
Consolidated statement of cash
flows
Current quarter
$A’000
Year to date
(12 months)
$A’000
2.
Cash flows from investing
activities
2.1
Payments to acquire:
(a) property, plant and equipment
(251
)
(1,474
)
(b) businesses (see item 10)
-
-
(c) investments
-
-
(d) intellectual property
(321
)
(321
)
(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
(572
)
(1,795
)
3.
Cash flows from financing
activities
3.1
Proceeds from issues of shares
-
45,037
3.2
Proceeds from issue of convertible
notes
-
-
3.3
Proceeds from exercise of share
options
453
453
3.4
Transaction costs related to issues of
shares, convertible notes or options
-
(4,192
)
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
453
41,298
Consolidated statement of cash
flows
Current quarter
$A’000
Year to date
(12 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
38,902
14,825
4.2
Net cash used in operating activities
(item 1.9 above)
(10,430
)
(27,314
)
4.3
Net cash from used in investing activities
(item 2.6 above)
(572
)
(1,795
)
4.4
Net cash from financing activities (item
3.10 above)
453
41,298
4.5
Effect of movement in exchange rates on
cash held
802
2,141
4.6
Cash and cash equivalents at end of
quarter
29,155
29,155
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
29,155
38,902
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)
29,155
38,902
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
(793
)
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 (685k),
Directors fees (80k), Clinical Advisory Board fees (11k), and
Bioscience Consultancy (17k).
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
3,300
9.2
Product manufacturing and operating
costs
1,000
9.3
Advertising and marketing
3,500
9.4
Leased assets
300
9.5
Staff costs
6,400
9.6
Administration and corporate costs
2,400
9.7
Other (provide details if material)
-
9.8
Total estimated cash outflows*
16,900
* Pertains to outflows only, inflows from customer receipts and
government contracts, which totalled $5,040 for the quarter ended
30 June 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
+ See chapter 19 for defined terms 1 September 2016
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 July 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190730006126/en/
U.S. Media Sam Brown, Inc. Christy Curran Phone +1
615 414 8668 christycurran@sambrown.com
O.U.S. Media Monsoon Communications Sarah Kemter
Phone +61 (0)3 9620 3333 Mobile +61 (0)407 162 530
sarahk@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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