Share purchase plan (SPP) also announced to
allow eligible shareholders to purchase up to A$3.0 million in
shares
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced an institutional placement of
A$40.0 million (Institutional Placement) to fund the marketing and
sales effort to support U.S. market launch of the RECELL® System,
clinical and research and development to facilitate pipeline
advancement, and general working capital requirements.
Avita has received under the Institutional Placement commitments
from U.S., Australian and international institutional and
sophisticated investors for a placement of A$40.0 million at an
issue price of A$0.080 per share, with the placement to occur in
two tranches. Tranche 1 of the institutional placement, totaling
A$24.5 million, is expected to settle on 7 December 2018 without
the need for prior shareholder approval. Settlement of Tranche 2
totaling A$15.2 million is subject to shareholder approval at an
Extraordinary General Meeting to be held in January 2018.
“The recent U.S. approval to the RECELL System for the treatment
of burns was a transformative event for AVITA, and we appreciate
the support of our shareholders as we advance to the U.S. market
launch,“ said Dr. Michael Perry, Chief Executive Officer. “Proceeds
from this placement will ensure that we are positioned to fully
realize the opportunity provided by the FDA approval and allows us
to advance our pipeline beyond burns in additional high-value areas
such as the treatment of traumatic wounds and vitiligo.”
Institutional Placement
The Institutional Placement was managed by Cowen and Company,
LLC in the U.S. as lead placement agent and Bell Potter as lead
Australian manager. The Company has received commitments for A$40.0
million at an issue price of A$0.080 per fully paid ordinary share.
Upon completion of the placement, the Company will issue up to 500
million shares to U.S., Australian and international institutional
and sophisticated investors to whom disclosure was not required
pursuant to Chapter 6D of the Corporations Act 2001. The issue
price of $0.080 per share represents a 2.4 percent discount to the
last closing price on 29 November 2018 price prior to the Company
seeking a trading halt. The new AVITA shares to be issued under the
Institutional Placement will rank equally with existing AVITA
shares on issue.
Tranche 1 of the Institutional Placement totals A$24,803,761 of
proceeds and the issuance of 310,047,015 shares. For Tranche 1 the
Company will issue 186,028,209 shares under its 15 percent
placement capacity (under ASX Listing Rule 7.1) and 124,018,806
shares under its 10 percent placement capacity (under ASX Listing
Rule 7.1A, referred to below as the "7.1A Placement")). Tranche 2
totals A$15,196,239 of proceeds and the issuance of 189,952,985
shares, and settlement is contingent upon shareholder approval at
Extraordinary General Meeting to be held in January 2019.
Share Purchase Plan
To recognize the support of current shareholders of AVITA, the
Company is also announcing a share purchase agreement (SPP) that
will allow eligible shareholders to purchase up to A$15,000 of
AVITA Medical ordinary shares at a purchase price of A$0.080 per
share, limited to A$3.0 million in total. Eligible shareholders are
those who are recorded on the Company's share register at 5:00 p.m.
AEDT on 3 December 2018. Details of the SPP will be provided to
shareholders this week in a separate communication.
Additional Disclosures Regarding 7.1A Placement
As the Company is issuing Shares under its ASX Listing Rule 7.1A
capacity, it provides the following further information (pursuant
to ASX Listing Rule 3.10.5A):
- Existing shareholders will be diluted
by 8.5% as a result of the issue of the 7.1A Placement under ASX
Listing Rule 7.1A (although, to the extent the investors are
already shareholders, their relative holdings will increase or
decrease to a lesser extent);
- As announced below, the Company also
intends making an offer to existing Shareholders under a Share
Purchase Plan at the same price as under the 7.1A Placement. This
proposed offer under the Share Purchase Plan is limited in
aggregate to $3.0 million and the Company considered it was in the
best interests of shareholders to undertake the 7.1A Placement as
the most efficient and most certain means of raising capital
quickly and attracting cornerstone institutional investors, but
while still offering existing shareholders the ability to
participate in the SPP at the same price as the institutional
investors;
- The 7.1A Placement was not
underwritten, but managed by the lead placement agent and the lead
Australian manager, for which the Company will pay a base
commission ranging from 6 to 7 percent of the 7.1A Placement
depending on the location of the investor, and;
- The Company has also incurred further
legal and listing fees in relation to the 7.1A Placement. ###
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 produces 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 7,000 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 for a full
description of 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181203006101/en/
US MediaSyneos Health Public RelationsChristian
PflaumerPhone +1-212-229-8412Nicole BeckstrandPhone
+1-858-431-9611AVITAMedicalTeam@syneoshealth.com
OUS MediaMonsoon CommunicationsSarah KemterPhone +61 (0)3
9620 3333Mobile +61 (0)407 162 530sarahk@monsoon.com.au
Investors:Westwicke PartnersCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.com
AVITA Medical LtdDale A. SanderChief Financial
OfficerPhone +1-661-367-9178dsander@avitamedical.com
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