Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
provides an update on its revenue and operational performance for
the quarter ended 31 March 2024 (Q1 2024).
Summary: Q1 2024 financial
performance
The Company reports unaudited total revenue of
US$114.9M1 (AU$175.0M), an increase of 18% on the prior quarter
(US$97.1M2 or AU$148.1M). Revenue was primarily generated from
sales of Telix’s prostate cancer imaging product Illuccix®.
U.S. revenue grew by 18% to US$111.8M (US$95.1M
in Q4 2023), compared to 11% growth between Q3 2023 and Q4
2023.
Dr Christian Behrenbruch, Managing Director and
Group CEO of Telix, commented, “The continued, consistent growth of
our precision diagnostics business is further evidence of an
effective market growth strategy for our prostate cancer franchise.
The dual benefit of an early revenue stream, and the ability to
fund our late-stage therapeutic programs ensures we are on track to
achieve major milestones in 2024 including the progression of three
drug approval submissions in the U.S. and the international
expansion of our Phase III ProstACT GLOBAL therapy trial in
prostate cancer, subject to requisite regulatory approvals.
“The recently closed acquisitions of ARTMS, Inc.
(ARTMS) and IsoTherapeutics Group (IsoTherapeutics) enhance the
vertical integration of our business and differentiate Telix as a
leading independent radiopharmaceutical company worldwide by adding
manufacturing capabilities and facilities, and isotope production
technologies to the Telix Group of companies.”
Q1 2024 operational
highlights
Telix continued to progress an extensive
oncology pipeline:
- Investigational New Drug (IND) application submitted to the
U.S. Food and Drug Administration (FDA) to start the ProstACT
GLOBAL Phase III trial of TLX5913 in the U.S.
- Continued enrolment of ProstACT GLOBAL at Australian sites with
13 new sites onboarded during the quarter
- TLX101-CDx (Pixclara™4, 18F-floretyrosine or 18F-FET) has been
granted Fast Track designation for PET5 characterisation of
glioma6. Concurrently, Telix is finalising its U.S. New Drug
Application (NDA) with submission on track for H1 2024
- The Biologics License Application (BLA) for TLX250-CDx
(Zircaix™4, 89Zr-DFO-girentuximab) is progressing under a
Breakthrough Therapy rolling review submission and is due for
completion by end-May. Telix has requested a Priority Review7 for
Zircaix™4, and
- Progression of a NDA for a novel prostate cancer imaging agent,
with a submission goal of this quarter.
Supply chain and manufacturing bolstered by recent
acquisitions
Telix continued to augment its product
development and manufacturing capabilities with two strategic
acquisitions:
- ARTMS, a company
which specialises in the physics, chemistry and materials science
of cyclotron-produced radionuclides. The acquisition brings an
advanced cyclotron-based diagnostic and therapeutic isotope
production platform, manufacturing plant and stockpile of
ultra-pure rare metals8.
- IsoTherapeutics, a
leading radiochemistry and bioconjugation firm. The acquisition
further enhances Telix’s in-house development capabilities and
expands Telix’s U.S. manufacturing footprint with particular focus
on bioconjugation and isotope processing9.
Full year 2024 outlook and guidance
Telix reaffirms guidance provided on 22 February
2024 for full year revenue expected to be in the range of US$445M
to $465M (AU$675M to $705M at current exchange rates), representing
an approximate 35-40% increase versus 2023.
The Company also reaffirms guidance that
research and development (R&D) investment is expected to
increase by 40-50% for full year 2024 (compared with 2023)
including external and internal costs funded by operating cash flow
and broadly in line with revenue growth.
The above guidance is based on expected global
and domestic economic conditions and is subject to known and
unknown risks, uncertainties and other factors that may cause our
actual results to differ materially. As such, investors are
cautioned not to place undue reliance on this guidance and in
particular Telix cannot guarantee a particular result. In compiling
financial forecasts, a number of key variables that may have a
significant impact on guidance have been identified and are
included below as a footnote10.
About Telix
Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on
the development and commercialisation of diagnostic and therapeutic
radiopharmaceuticals and associated medical devices. Telix is
headquartered in Melbourne, Australia, with international
operations in the U.S., 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 FDA11, by the
Australian Therapeutic Goods Administration (TGA)12, and by Health
Canada13. 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 CommunicationsEmail:
kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix
Pharmaceuticals Limited Board of Directors.
Legal Notices
The information contained in this announcement
is not intended to be an offer for subscription, invitation or
recommendation with respect to shares of Telix Pharmaceuticals
Limited (Telix) in any jurisdiction, including the United States.
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.
The information contained in this announcement is subject to change
without notification.
This announcement may contain forward-looking
statements that relate to anticipated future events, financial
performance, plans, strategies or business developments.
Forward-looking statements can generally be identified by the use
of words such as “may”, “expect”, “intend”, “plan”, “estimate”,
“anticipate”, “outlook”, “forecast” and “guidance”, or other
similar words. 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 the Company’s
good-faith assumptions as to the financial, market, regulatory and
other risks and considerations that exist and affect the Company’s
business 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
studies, 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, manufacturing activities and product marketing
activities; the commercialisation of Telix’s product candidates, if
or when they have been approved; 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. You
should read this announcement together with our risk factors, as
disclosed in our most recently filed reports with the ASX or on our
website.
To the maximum extent permitted by law, Telix
disclaims any obligation or undertaking to publicly update or
revise any forward-looking statements contained in this
announcement, whether as a result of new information, future
developments or a change in expectations or assumptions.
©2024 Telix Pharmaceuticals Limited. The Telix
Pharmaceuticals®, Illuccix®, Zircaix™4, Pixclara™4, ARTMS® and
IsoTherapeutics™ names and logos are trademarks of Telix
Pharmaceuticals Limited and its affiliates – all rights
reserved.
___________________
1 Conversion to AUD$ is at an average exchange
rate realised during Q1 2024 of AUD$1 = US$0.657 2 Conversion to
AUD$ is at an average exchange rate realised during Q4 2023 of
AUD$1 = US$0.656 3 177Lu rosopatamab tetraxetan, Telix’s lead
investigational radio antibody-drug conjugate (rADC) in prostate
cancer.4 Brand name subject to final regulatory approval.5 Positron
emission tomography.6 Telix ASX disclosure 16 April 2024. 7 A
Priority Review designation means FDA’s goal is to take action on
an application within six months (compared to 10 months under
standard review).8 Telix ASX disclosure 11 April 2024.9 Telix ASX
disclosure 9 April 2024.10 Key variables that could cause actual
results to differ materially include: the success and timing of
research and development activities; decisions by regulatory
authorities regarding approval of our products as well as their
decisions regarding label claims; competitive developments
affecting our products; the ability to successfully market new and
existing products; difficulties or delays in manufacturing; trade
buying patterns and fluctuations in interest and currency exchange
rates; legislation or regulations that affect product production,
distribution, pricing, reimbursement, access or tax; acquisitions
and divestitures; research collaborations; litigation or government
investigations; and Telix’s ability to protect its patents and
other intellectual property.11 Telix ASX disclosure 20 December
2021.12 Telix ASX disclosure 2 November 2021.13 Telix ASX
disclosure 14 October 2022.