Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
provides an update on its revenue and operational performance for
the quarter ended 30 June 2024 (Q2 2024).
Q2 2024 Financial Performance and
Guidance Upgrade
The Company reports unaudited total revenue of
approximately US$124M1 (AU$189M) primarily generated from sales of
Telix’s prostate cancer imaging product Illuccix®. This represents
an increase of 55% on the prior corresponding quarter (Q2 2023:
US$80M or AU$120M) and an increase of 8% on the previous quarter
(Q1 2024: US$115M or AU$175M). Revenue generated from sales of
Illuccix® in the United States (U.S.) was approximately US$121M
(AU$184M, Q2 2023: US$78M or AU$116M).
On the basis of these results, the Company has
upgraded revenue guidance for FY2024 which is now expected to be in
the range of US$490M to US$510M (AU$745M to AU$776M at current
exchange rates). This represents an approximate increase of 48% to
54% on 2023 revenue. Prior guidance was ranged at US$445M to
US$465M2 (AU$675M to AU$705M).
Dr Christian Behrenbruch, Managing Director and
Group Chief Executive Officer said, “We have continued to deliver
excellent quarterly growth in both revenue and dose volume sales of
Illuccix. We have leveraged our unrivalled scheduling flexibility
and clinical differentiation, to increase our market share and
minimise the impact of new entrants.”
Revenue guidance is based on approved products
in jurisdictions with a marketing authorisation3. Telix reaffirms
guidance for R&D expenditure, which remains at an expected
40-50% increase compared with 2023, funded by earnings.
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 footnote4.
The Company will release its interim report and
Appendix 4D for the six months ended 30 June 2024 on 22 August
2024.
Q2 2024 Operational
Highlights
Telix continued to progress its extensive
theranostic pipeline during the quarter. Highlights include
positive data from prostate cancer therapy programs:
- TLX591
(177Lu rosopatamab
tetraxetan): Telix reported a positive efficacy signal
from the ProstACT SELECT trial of TLX591, its lead investigational
radio antibody-drug conjugate (rADC) in prostate cancer. The median
radiographic progression-free survival (rPFS) of 8.8 months
compares favourably to small molecule radioligand therapy (RLT)
agents at a similar stage of development and builds on earlier
results from ProstACT SELECT confirming the favourable safety
profile and clinical utility of the short, two-dose treatment
regimen. TLX591 is being further evaluated in the Phase III
ProstACT GLOBAL trial. The study received Investigational New Drug
(IND) clearance from the U.S. Food and Drug Administration (FDA)
during the quarter. Multiple sites across the U.S. are now being
activated and preparing to dose first patients. Patient recruitment
continues at sites in Asia Pacific.
- TLX592
(225Ac-RADmAb®):
Successful proof-of-concept study completed for targeted alpha
therapy in prostate cancer. The initial results demonstrated
Telix’s proprietary RADmAb engineered antibody is rapidly
eliminated from the blood circulation and cleared via the liver,
desirable characteristics for use with alpha emitting
radioisotopes. Based on the outcomes of this trial, the program
will progress to a Phase I/II therapeutic trial with Actinium
225.
Telix is progressing multiple marketing
authorisation applications across its precision medicine
(diagnostic) portfolio, including:
- New Drug Application (NDA)
submission for new prostate cancer imaging agent TLX007-CDx
(PSMA-PET imaging5):
Telix submitted a NDA to the FDA for a new PSMA targeting prostate
cancer imaging agent designed to expand the availability,
distribution and scheduling flexibility for PSMA-PET imaging6. The
FDA is expected to confirm by the end of July 2024 whether the
submission is accepted for review. Confirmation of the PDUFA7 goal
date (review timeframe) is expected in early August 2024, in line
with FDA procedure.
- Kidney cancer imaging agent
TLX250-CDx (Zircaix®8,
89Zr-DFO-girentuximab) regulatory filing
completed: The Biologics License Application (BLA)
submission to the FDA for kidney cancer imaging has now been
completed9. The Company is expecting confirmation of the PDUFA goal
date from the FDA by end of July 2024. Concurrently the expanded
access and compassionate use programs for TLX250-CDx continue to
dose patients across the U.S., Australia and Europe in a
significant area of unmet patient need. Separately, a manuscript
reporting the final results from the pivotal Phase III ZIRCON study
is in the late stages of peer-review for publication in a leading
medical journal.
- Brain cancer imaging agent
TLX101-CDx (Pixclara™8,
18F-floretyrosine or
18F-FET) regulatory package:
Telix participated in a pre-NDA meeting with the FDA on 12 June
2024, with the purpose of consulting on the final package and
likely scope of label indications, including alignment on the final
clinical package. On the basis of this positive discussion the
Company is now finalising its NDA for submission during Q3
2024.
- European Union (EU), United
Kingdom (UK) and Brazil regulatory filings for Illuccix®:
The marketing authorisation applications for the EU and the UK are
continuing to progress. All regulator questions raised in the EU
marketing authorisation application within the standard clock stop
period have been addressed and no substantive issues have been
identified. The Company will communicate the final decision date
once set by the competent authority, the German Federal Institute
for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und
Medizinprodukte, BfArM). Telix is expecting to receive a
regulator’s assessment report by the end of July 2024 from the UK
Medicines & Healthcare Products Regulatory Agency (MHRA), which
is expected to include final questions and a timeline for the
remainder of the review. The marketing authorisation application in
Brazil with Telix’s partner Grupo GSH is in the final stages of
review with an approval decision anticipated from the Brazilian
Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria,
ANVISA) during Q3 2024 based on current information.
Subsequent to the end of Q2 2024, the U.S.
Centers for Medicare & Medicaid Services (CMS) announced
proposed changes for the Hospital Outpatient Prospective Payment
System (OPPS) rule, which would improve payments to Medicare
patients for diagnostic radiopharmaceuticals in the U.S., including
Illuccix® and future Telix diagnostic products, if approved10.
Telix welcomes the proposal to keep the payment for the diagnostic
radiopharmaceuticals separate from the nuclear medicine test (scan)
after transitional pass-through payment status expires, which will
facilitate continued patient access11. The proposal is now in a
60-day comment period, with a final rule to be issued in early
November 2024 and take effect 1 January 2025.
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)12, by the Australian Therapeutic Goods
Administration (TGA) 13, and by Health Canada14. 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 Board
of Telix Pharmaceuticals Limited.
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®, Pixclara™8 and Zircaix®8 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 Q2 2024 of AUD$1 = US$0.6582 Telix ASX disclosures 22
February and 17 April 2024.3 Illuccix® has received a marketing
authorisation in Australia, Canada and the U.S.4 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.5 Imaging of prostate-specific membrane antigen with
positron emission tomography.6 Telix ASX disclosure 27 May 2024.7
Prescription Drug User Fee Act.8 Brand name subject to final
regulatory approval.9 Telix ASX disclosure 3 June 2024.10 CMS Press
Release 10 July 2024.11 Telix ASX disclosure 11 July 2024.12 Telix
ASX disclosure 20 December 2021.13 Telix ASX disclosure 2 November
2021.14 Telix ASX disclosure 14 October 2022.