Summary: Q1 2024 financial performance
The Company reports unaudited total revenue of
Dr
“The recently closed acquisitions of
Q1 2024 operational highlights
- 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 theU.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 itsU.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
- 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
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
About
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
Visit www.telixpharma.com for further information about
Telix Investor Relations
Ms. Kyahn Williamson
SVP 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.
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The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of
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,
©2024
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1 Conversion to AUD$ is at an average exchange rate realised during Q1 2024 of AUD$1 =
2 Conversion to AUD$ is at an average exchange rate realised during Q4 2023 of AUD$1 =
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
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
9 Telix ASX disclosure
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
12 Telix ASX disclosure
13 Telix ASX disclosure
Source:
2024 GlobeNewswire, Inc., source