Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch
30 9월 2024 - 9:55AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced it has entered into a convertible note subscription
agreement with its largest shareholder Gregory George (“Investor”)
for issue, at its sole discretion, up to US$50.0 million (A$72.7
million) convertible notes on approval by the United States Food
and Drug Administration (FDA) of Mesoblast’s lead product candidate
Ryoncil® (remestemcel-L) in the treatment of children with
steroid-refractory acute graft versus host disease (SR-aGvHD). The
funding is available at Mesoblast’s option and will enable the
Company to seamlessly implement its go-to-market commercial
strategy. Mesoblast anticipates a decision prior to or on the FDA’s
Prescription Drug User Fee Act (PDUFA) goal date of January 7,
2025.
Mesoblast Chief Executive Silviu Itescu said:
“We appreciate the ongoing support from our major shareholder in
ensuring that the Company is well capitalized for commercial
product launch and can hit the ground running immediately following
approval of RYONCIL by FDA.”
Activities For Go to Market Strategy for
RYONCIL in children with SR-aGvHD
- Hiring of select
senior positions to build targeted commercial team has
commenced.
- Key Pre-Launch
Activities include:
- Market Access
initiates payer outreach
- Medical provides
education to payers
- Corporate
leadership initiates engagement with Top 15 centers
- Regional sales
directors lead center profiling
- Ongoing KOL
engagement with greatest experience using RYONCIL at highest volume
centers
- Non-promotional
activities including profiling high-volume centers, education on
disease awareness & unmet needs, and payer engagement
- Post-launch -
Staged approach based on centers with highest volume and experience
with product.
- Targeted sales
force with experience in bone marrow transplant centers - 15
highest volume centers account for ~50% of patients.
Key terms of the Convertible
Notes
Mesoblast at its sole discretion, to issue up to
US$50 million of convertible notes in tranches of US$10 million at
any time following an FDA approval of RYONCIL for a 90-day period.
The convertible notes have a coupon of 5% per annum on the face
value of issued notes. A commitment fee comprising 2 million
warrants to subscribe for up to 2 million ordinary shares (or
200,000 Mesoblast ADRs) is payable on signing of the convertible
note subscription agreement and a further commitment fee comprising
3 million warrants to subscribe for up to 3 million ordinary shares
(300,000 Mesoblast ADRs) is payable on the first issue of
convertible notes. The warrants have an exercise price of US$9.06
per ADR and a maturity date of 4 years from the date of first
issuance of the warrants.
The conversion price of the convertible notes
will be US$9.06 per ADR (American Depository Receipt) equivalent to
A$1.32 per ASX-listed share, representing a 25% premium to
Mesoblast’s 5-day volume weighted average share price (“VWAP”) up
to and including the close of trading on NASDAQ on Friday,
September 27th, 2024.
The maturity date of the convertible notes will
be 4 years after the first issuance of notes (unless redeemed or
converted earlier). At any time up to the maturity date, the
Investor may elect to convert convertible notes issued into fully
paid ordinary shares or ADRs of Mesoblast, at the conversion
price.
The convertible notes will be unsecured and be
subordinated to the Company's two existing secured financing
facilities. The conversion price is subject to adjustment
mechanisms in the event of future share issues, capital reductions,
share consolidations and other corporate actions in accordance with
customary adjustment rules.
About Mesoblast Mesoblast (the
Company) is a world leader in developing allogeneic (off-the-shelf)
cellular medicines for the treatment of severe and life-threatening
inflammatory conditions. The Company has leveraged its proprietary
mesenchymal lineage cell therapy technology platform to establish a
broad portfolio of late-stage product candidates which respond to
severe inflammation by releasing anti-inflammatory factors that
counter and modulate multiple effector arms of the immune system,
resulting in significant reduction of the damaging inflammatory
process.
Mesoblast has a strong and extensive global
intellectual property portfolio with protection extending through
to at least 2041 in all major markets. The Company’s proprietary
manufacturing processes yield industrial-scale, cryopreserved,
off-the-shelf, cellular medicines. These cell therapies, with
defined pharmaceutical release criteria, are planned to be readily
available to patients worldwide.
Mesoblast is developing product candidates for
distinct indications based on its remestemcel-L and
rexlemestrocel-L allogeneic stromal cell technology platforms.
Remestemcel-L is being developed for inflammatory diseases in
children and adults including steroid refractory acute graft versus
host disease, and biologic-resistant inflammatory bowel disease.
Rexlemestrocel-L is being developed for advanced chronic heart
failure and chronic low back pain. Two products have been
commercialized in Japan and Europe by Mesoblast’s licensees, and
the Company has established commercial partnerships in Europe and
China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United
States and Singapore and is listed on the Australian Securities
Exchange (MSB) and on the Nasdaq (MESO). For more information,
please see www.mesoblast.com, LinkedIn: Mesoblast Limited and
Twitter: @Mesoblast
Forward-Looking StatementsThis
press release includes forward-looking statements that relate to
future events or our future financial performance and involve known
and unknown risks, uncertainties and other factors that may cause
our actual results, levels of activity, performance or achievements
to differ materially from any future results, levels of activity,
performance or achievements expressed or implied by these
forward-looking statements. We make such forward-looking statements
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
Forward-looking statements should not be read as a guarantee of
future performance or results, and actual results may differ from
the results anticipated in these forward-looking statements, and
the differences may be material and adverse. Forward-looking
statements include, but are not limited to, statements about: the
initiation, timing, progress and results of Mesoblast’s preclinical
and clinical studies, and Mesoblast’s research and development
programs; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies, including
multi-national clinical trials; Mesoblast’s ability to advance its
manufacturing capabilities; the timing or likelihood of regulatory
filings and approvals (including any future decision that the FDA
may make on the BLA for remestemcel-L for pediatric patients with
SR-aGVHD), manufacturing activities and product marketing
activities, if any; the commercialization of Mesoblast’s product
candidates, if approved; regulatory or public perceptions and
market acceptance surrounding the use of stem-cell based therapies;
the potential for Mesoblast’s product candidates, if any are
approved, to be withdrawn from the market due to patient adverse
events or deaths; the potential benefits of strategic collaboration
agreements and Mesoblast’s ability to enter into and maintain
established strategic collaborations; Mesoblast’s ability to
establish and maintain intellectual property on its product
candidates and Mesoblast’s ability to successfully defend these in
cases of alleged infringement; the scope of protection Mesoblast is
able to establish and maintain for intellectual property rights
covering its product candidates and technology; estimates of
Mesoblast’s expenses, future revenues, capital requirements and its
needs for additional financing; Mesoblast’s financial performance;
developments relating to Mesoblast’s competitors and industry; and
the pricing and reimbursement of Mesoblast’s product candidates, if
approved. You should read this press release together with our risk
factors, in our most recently filed reports with the SEC or on our
website. Uncertainties and risks that may cause Mesoblast’s actual
results, performance or achievements to be materially different
from those which may be expressed or implied by such statements,
and accordingly, you should not place undue reliance on these
forward-looking statements. We do not undertake any obligations to
publicly update or revise any forward-looking statements, whether
as a result of new information, future developments or
otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
Media |
Paul Hughes |
BlueDot Media |
T: +61 3 9639 6036 |
Steve Dabkowski |
E: investors@mesoblast.com |
T: +61 419 880 486 |
|
E: steve@bluedot.net.au |
Mesoblast (NASDAQ:MESO)
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