Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
announces its financial results for the half-year ended 30 June
2024. All figures are in AU$ unless otherwise stated.1
H1 2024
financial highlights
- Total Group revenue of $364.0 million, an increase of 65%
compared to H1 2023, reflecting continued growth in sales of its
prostate cancer imaging agent, Illuccix® in the United States
(U.S.), now in its second full year of commercial sales.
- Net profit after tax of $29.7 million compared to a net loss of
$14.3 million in H1 2023.
- Gross margin improved to 66% (compared to 63% in H1 2023),
supported by stable selling price of Illuccix® and disciplined cost
control.
- Adjusted earnings before interest, tax, depreciation, and
amortisation (Adjusted EBITDA) of $57.5 million, an increase of
$22.8 million or 66%, when compared to $34.7 million in H1
2023.
- Adjusted earnings before interest, tax, depreciation,
amortisation and research and development (Adjusted EBITDAR) of
$137.1 million, a significant uplift from $81.3 million in H1 2023,
demonstrating the profitability of the commercial
organisation.
- Net cash generated from operating activities of $39.1 million
(compared to $13.3 million in H1 2023), primarily from sales of
Illuccix®.
- Closing cash balance was $118.8 million as at 30 June 2024.
Subsequent to the reporting period, Telix completed a convertible
bond financing, raising $650.0 million (before costs).
- Telix reaffirms its full year 2024 revenue guidance of US$490M
to US$510M ($745 million to $776 million at current exchange
rates), representing a ~48-54% increase on FY 2023. Telix also
confirms previously advised guidance for R&D expenditure
remains unchanged.2
H1 2024
operational highlights
- Positive efficacy data generated by the
ProstACT SELECT (TLX591) study, and proof-of-concept in the CUPID
(TLX592) study reinforce the clinical potential and differentiation
of the Company's beta and alpha prostate cancer therapy
programs.
- For the Phase III ProstACT GLOBAL
trial (TLX591), the Investigational New Drug application was
cleared by the U.S. Food and Drug Administration (FDA) and site
activation commenced in the U.S.
- Expansion of the commercial precision
medicine (diagnostic imaging) portfolio:
- Regulatory filing of a New Drug
Application (NDA) for a new PSMA-PET3 product (TLX007-CDx) accepted
by the FDA.
- Regulatory filings for two
additional new products: TLX101-CDx (Pixclara®4 for imaging of
glioma) and TLX250- CDx (Zircaix®4 for imaging of kidney cancer)
expected in Q3 2024, and Q4 20245, respectively.
- Illuccix® European Union (EU) and
United Kingdom (UK) submissions progressing in line with
expectations and in accordance with guidance to industry. All
questions raised by the German Federal Institute for Drugs and
Medical Devices (Bundesinstitut für Arzneimittel und
Medizinprodukte, BfArM) as EU competent authority during standard
review “clock-stop” period have been addressed. The UK Medicines
& Healthcare Products Regulatory Agency (MHRA) regulator's
assessment report has been received with no substantive issues
raised. Decisions expected in H2 2024.
- Illuccix® submission with the
Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia
Sanitaria, ANVISA) in the final stages of review with an approval
decision anticipated during Q3 2024 based on current information.
Approval is expected, however regulator has been experiencing
strike action.
- Completion of the ARTMS and
IsoTherapeutics acquisitions further enhance ongoing vertical
integration strategy, delivering greater control over supply chain
and additional self-sufficiency and capabilities in manufacturing,
particularly for gallium-68 (68Ga) and zirconium-89 (89Zr) to
support near-term revenue and margin growth.
Dr Christian Behrenbruch, Managing Director and Group Chief
Executive Officer, commented on the result:
“Telix continues to grow revenue from Illuccix®, increase gross
profit margin and manage costs effectively, while investing for
future growth. Our achievements in the first half of 2024 have
created value for shareholders and positioned the Company for
success on multiple fronts. Building on our commercial success with
Illuccix®, we are focused on expanding the near-term opportunity in
precision medicine diagnostics with three new products planned for
launch in 2025, subject to regulatory approval. At the same time,
new efficacy data from the ProstACT SELECT trial has reinforced the
therapeutic potential of TLX591 – our Phase III asset for prostate
cancer therapy, while we have a number of additional significant
clinical milestones ahead across our therapeutic pipeline.
“We also continue to build out our internal manufacturing
capability, which we believe is a competitive advantage for our
radiopharmaceutical supply chain and ability to deliver patient
doses globally. Telix’s successful $650 million convertible bond
offering will facilitate our ambitions in this regard, while also
positioning us to accelerate clinical development on key programs
and capitalise on potential strategic M&A opportunities.
“We believe the radiopharmaceutical sector is at an inflection
point and Telix has the proven commercial ability, clinical
experience and balance sheet strength to advance our leading-edge
theranostic pipeline. With a proven revenue stream and a clear path
to future business growth, Telix is positioned at the vanguard of
this fast-growing field.”
Investor call
An investor webcast will be held at 9.00am AEST on Friday, 23
August 2024 (7.00pm EDT, Thursday, 22 August 2024).
Participants can register for the webcast and find audio call
details at the following link: https://s1.c-conf.com/
diamondpass/10041010-puhyt.html
About Telix
Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development
and commercialisation of therapeutic and diagnostic
radiopharmaceuticals and associated medical devices. Telix is
headquartered in Melbourne, Australia, with international
operations in the United States, Europe (Belgium and Switzerland),
and Japan. Telix is developing a portfolio of clinical and
commercial stage products that aims to address significant unmet
medical needs in oncology and rare diseases.Telix is listed on the
Australian Securities Exchange (ASX: TLX).
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide
injection, (also known as 68Ga PSMA-11 and marketed under the brand
name Illuccix®), has been approved by the U.S. Food and Drug
Administration (FDA)6, by the Australian Therapeutic Goods
Administration (TGA)7, and by Health Canada8. No other Telix
product has received a marketing authorisation in any
jurisdiction.
Visit www.telixpharma.com for further information about Telix,
including details of the latest share price, announcements made to
the ASX, investor and analyst presentations, news releases, event
details and other publications that may be of interest. You can
also follow Telix on X and LinkedIn.
Telix Investor
Relations
Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor
Relations and Corporate Communications Email:
kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix
Pharmaceuticals Limited Board of Directors
Legal Notices
You should read this announcement together with our risk
factors, as disclosed in our most recently filed reports with the
Australian Securities Exchange (ASX) or on our website.
The information contained in this announcement is not intended
to be an offer for subscription, invitation or recommendation with
respect to securities of Telix Pharmaceuticals Limited (Telix) in
any jurisdiction, including the United States. The information and
opinions contained in this announcement are subject to change
without notification. To the maximum extent permitted by law, Telix
disclaims any obligation or undertaking to update or revise any
information or opinions contained in this announcement, including
any forward-looking statements (as referred to below), whether as a
result of new information, future developments, a change in
expectations or assumptions, or otherwise. No representation or
warranty, express or implied, is made in relation to the accuracy
or completeness of the information contained or opinions expressed
in the course of this announcement.
This announcement may contain forward-looking statements that
relate to anticipated future events, financial performance, plans,
strategies or business developments. Forward-looking statements can
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“expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”,
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or other similar terms or expressions. Forward-looking statements
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. Forward-looking
statements are based on Telix’s good-faith assumptions as to the
financial, market, regulatory and other risks and considerations
that exist and affect Telix’sbusiness and operations in the future
and there can be no assurance that any of the assumptions will
prove to be correct. In the context of Telix’s business,
forward-looking statements may include, but are not limited to,
statements about:the initiation, timing, progress and results of
Telix’s preclinical and clinical trials, and Telix’s research and
development programs; Telix’s ability to advance product candidates
into, enrol and successfully complete, clinical studies, including
multi-national clinical trials; the timing or likelihood of
regulatory filings and approvals for Telix’s product candidates,
manufacturing activities and product marketing activities; Telix’s
sales, marketing and distribution and manufacturing capabilities
and strategies; the commercialisation of Telix’s product
candidates, if or when they have been approved; Telix’s ability to
obtain an adequate supply of raw materials at reasonable costs for
its products and product candidates; estimates of Telix’s expenses,
future revenues and capital requirements; Telix’s financial
performance; developments relating to Telix’s competitors and
industry; and the pricing and reimbursement of Telix’s product
candidates, if and after they have been approved. Telix’s actual
results, performance or achievements may be materially different
from those which may be expressed or implied by such statements,
and the differences may be adverse. Accordingly, you should not
place undue reliance on these forward-looking statements.
Telix uses various non-IFRS information to reflect its
underlying performance. For further information, the reconciliation
of non-IFRS financial information to Telix's statutory measures,
reasons for usefulness and calculation methodology, please refer to
the Alternative performance measures section in Telix’s Annual
Report.
©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®,
Illuccix®, Pixclara®4 and Zircaix®4 names and logos are trademarks
of Telix Pharmaceuticals Limited and its affiliates – all rights
reserved.
_______________________
- Conversion to AU$ is at the exchange rate on the relevant
transaction date. The average exchange rate realised during the
period was AU$1 = US$0.66; AU$1 = €0.58.
- Telix ASX disclosures 18 July 2024 and 22 February 2024.
Revenue guidance is based on approved products in jurisdictions
with a marketing authorisation. Illuccix® has received a marketing
authorisation in Australia, Canada and the U.S.
- Imaging of prostate-specific membrane antigen with positron
emission tomography.
- Brand name subject to final regulatory approval.
- FDA has requested further validation for the TLX250-CDx
Biologics License Application (BLA) filing to advance to full
review. Telix ASX disclosure 31 July 2024.
- Telix ASX disclosure 20 December 2021.
- Telix ASX disclosure 2 November 2021.
- Telix ASX disclosure 14 October 2022.