AVITA Medical Announces Institutional Placement of A$120.0 Million to Support Commercial Growth and Pipeline Development
November 12 2019 - 7:24PM
Business Wire
AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine
company with a technology platform positioned to address unmet
medical needs in therapeutic skin restoration, announced today an
institutional placement of A$120.0 million (Institutional
Placement) to fund pipeline development of new indications,
including optimizing support for clinical trials and development
projects, as well as the Company’s continued U.S. commercial growth
strategy.
The Institutional Placement was managed by Bell Potter as sole
lead manager. Cowen served as financial advisor to the Company in
connection with the Institutional Placement. Lake Street Capital
Markets also acted as a financial advisor to AVITA Medical. The
Company has received commitments for A$120.0 million at an issue
price of A$0.59 per fully paid ordinary share, representing a 7.2
percent discount to the 30-day VWAP, and a 14.5 percent discount to
the last closing price on 8 November 2019. The new AVITA shares to
be issued under the Institutional Placement will rank equally with
existing AVITA shares on issue. The Institutional Placement will
occur in a single tranche, and issue 203,389,831 shares to
international and Australian sophisticated investors under its 15
percent placement capacity (under ASX Listing Rule 7.1).
“We are grateful for the confidence and conviction of the
investors who have joined us in our mission to transform burn care
with our revolutionary RECELL® System and to promptly execute on
our pipeline of add-on indications,” said Dr. Mike Perry, Chief
Executive Officer. “This financing reflects our shared excitement
for, and strong confidence in, AVITA Medical’s myriad near-term
growth opportunities. These include trauma/soft tissue
reconstruction, vitiligo, our next generation RECELL device to
facilitate use of the RECELL System in the outpatient setting, and
pediatric scald wounds, as well as efforts to enable research
programs to support the advancement and extension of our existing
intellectual property. Through diligent and focused execution on
our highly de-risked pipeline of new indications, we have the
opportunity to access the full potential of our innovative
regenerative medicine platform to advance patient care that
addresses unmet medical needs, while aggressively growing our top
line revenues and ultimately building a robust self-sustaining
business.”
Accelerating pipeline development
The funds from the Institutional Placement will enable AVITA
Medical to fast-track progression of clinical development programs
and to accelerate its broader commercialization strategy. Key
initiatives include:
- Initiating U.S. pivotal trials to establish the safety and
efficacy of the RECELL System in soft tissue reconstruction and
traumatic wounds, as well as early intervention in the treatment of
pediatric scald wounds
- Further development and submission to the FDA of a next
generation RECELL System to facilitate access to the large
outpatient market
- Pilot studies with the RECELL System for the treatment of
vitiligo, and subsequent rapid advancement into a pivotal clinical
trial to secureadva this indication in the U.S.
- Conducting research and preclinical studies to augment our
existing IP portfolio
- Securing marketing approval and reimbursement for the RECELL
System in Japan in collaboration with our partner, COSMOTEC, an M3
Group company targeting patients with burn injuries, soft tissue
wounds, chronic wounds (DFUs/VLUs), and vitiligo
- Early phase research into cell and cell-based gene therapy for
skin regeneration that either corrects inborn genetic defects of
the skin or contributes materially to rejuvenation
In addition to the successful Institutional Placement, the
Company’s CEO Dr Michael Perry has sold 23,470,000 shares to enable
him to meet his tax obligations relating to previously issued
Restricted Stock Units (RSUs).
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.
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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
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