Telix Exceeds FY24 Guidance with US$142M Q4 Revenue
Telix Pharmaceuticals reported strong Q4 2024 performance with unaudited revenue of approximately US$142 million, marking a 46% increase year-over-year and a 5% increase quarter-over-quarter. The company exceeded its FY2024 guidance with total unaudited revenue of US$517 million, representing a 55% increase over FY2023.
Key developments include the submission of a Biologics License Application (BLA) for renal cancer imaging candidate TLX250-CDx, FDA Priority Review for brain cancer imaging agent TLX101-CDx with a PDUFA date of April 26, 2025, and progress in therapeutic programs including prostate cancer (TLX591), kidney cancer (TLX250), and glioblastoma (TLX101). The company also acquired FAP-targeting assets and completed strategic partnerships, including an AI imaging collaboration with Subtle Medical.
Telix commenced trading on the Nasdaq Global Select Market under symbol 'TLX' in November 2024, while maintaining its ASX listing.
Telix Pharmaceuticals ha riportato eccellenti risultati per il quarto trimestre del 2024, con un fatturato non verificato di circa 142 milioni di dollari USA, segnando un aumento del 46% rispetto all'anno precedente e un incremento del 5% rispetto al trimestre precedente. L'azienda ha superato le previsioni per l'intero anno fiscale 2024, con un fatturato totale non verificato di 517 milioni di dollari USA, che rappresenta un aumento del 55% rispetto all'anno fiscale 2023.
Sviluppi chiave includono la presentazione di una domanda di licenza biologica (BLA) per il candidato per l'imaging del cancro renale TLX250-CDx, la revisione prioritaria da parte della FDA per l'agente per l'imaging del cancro al cervello TLX101-CDx con una data PDUFA del 26 aprile 2025, e progressi nei programmi terapeutici che includono il cancro alla prostata (TLX591), il cancro renale (TLX250) e il glioblastoma (TLX101). L'azienda ha anche acquisito beni mirati a FAP e completato partnership strategiche, inclusa una collaborazione per l'imaging AI con Subtle Medical.
Telix ha iniziato a quotarsi sul Nasdaq Global Select Market con il simbolo 'TLX' a novembre 2024, mantenendo al contempo la propria quotazione ASX.
Telix Pharmaceuticals reportó un sólido desempeño en el cuarto trimestre de 2024, con ingresos no auditados de aproximadamente 142 millones de dólares estadounidenses, lo que representa un aumento del 46% en comparación con el año anterior y un incremento del 5% en comparación con el trimestre anterior. La compañía superó su guía para el año fiscal 2024 con un ingreso total no auditado de 517 millones de dólares estadounidenses, que representa un aumento del 55% respecto al año fiscal 2023.
Entre los desarrollos clave se incluye la presentación de una Solicitud de Licencia Biológica (BLA) para el candidato de imágenes de cáncer renal TLX250-CDx, la Revisión Prioritaria de la FDA para el agente de imágenes de cáncer cerebral TLX101-CDx con una fecha de PDUFA del 26 de abril de 2025, y avances en programas terapéuticos que incluyen cáncer de próstata (TLX591), cáncer renal (TLX250) y glioblastoma (TLX101). La empresa también adquirió activos dirigidos a FAP y completó asociaciones estratégicas, incluida una colaboración de imágenes de IA con Subtle Medical.
Telix comenzó a cotizar en el Nasdaq Global Select Market bajo el símbolo 'TLX' en noviembre de 2024, manteniendo su cotización en la ASX.
텔릭스 제약은 2024년 4분기에 비감사 수익 약 1억 4천 2백만 달러를 기록하며, 전년 대비 46% 증가하고 전분기 대비 5% 증가한 강력한 실적을 발표했습니다. 이 회사는 2024 회계연도 가이드를 초과 달성하며 총 비감사 수익 5억 1천 7백만 달러를 기록하여 2023 회계연도 대비 55% 증가했습니다.
주요 개발 사항으로는 신장암 이미징 후보 TLX250-CDx에 대한 생물학적 라이센스 신청(BLA) 제출, 2025년 4월 26일 PDUFA 날짜가 있는 뇌암 이미징 제제 TLX101-CDx에 대한 FDA 우선 검토, 전립선암(TLX591), 신장암(TLX250) 및 교모세포종(TLX101)을 포함한 치료 프로그램 진행 상황이 있습니다. 이 회사는 또한 FAP 표적 자산을 인수하고 Subtle Medical과 AI 이미징 협업을 포함한 전략적 파트너십을 완료했습니다.
텔릭스는 2024년 11월 'TLX' 기호로 나스닥 글로벌 선택 시장에서 거래를 시작했으며, ASX 상장도 유지하고 있습니다.
Telix Pharmaceuticals a annoncé de solides performances au quatrième trimestre 2024 avec des revenus non vérifiés d'environ 142 millions de dollars US, marquant une augmentation de 46 % par rapport à l'année précédente et une augmentation de 5 % par rapport au trimestre précédent. L'entreprise a dépassé ses prévisions pour l'exercice 2024 avec un revenu total non vérifié de 517 millions de dollars US, représentant une augmentation de 55 % par rapport à l'exercice 2023.
Les développements clés incluent la soumission d'une demande de licence biologique (BLA) pour le candidat d'imagerie du cancer rénal TLX250-CDx, l'examen prioritaire de la FDA pour l'agent d'imagerie du cancer du cerveau TLX101-CDx avec une date de PDUFA fixée au 26 avril 2025, et des progrès dans des programmes thérapeutiques, y compris le cancer de la prostate (TLX591), le cancer rénal (TLX250) et le glioblastome (TLX101). L'entreprise a également acquis des actifs ciblant le FAP et a complété des partenariats stratégiques, y compris une collaboration en imagerie AI avec Subtle Medical.
Telix a commencé à se négocier sur le Nasdaq Global Select Market sous le symbole 'TLX' en novembre 2024, tout en maintenant son inscription à l'ASX.
Telix Pharmaceuticals berichtete über eine starke Leistung im vierten Quartal 2024 mit einem unverifizierten Umsatz von etwa 142 Millionen US-Dollar, was einem Anstieg von 46 % im Jahresvergleich und einem Anstieg von 5 % im Quartalsvergleich entspricht. Das Unternehmen übertraf seine Prognose für das Geschäftsjahr 2024 mit einem Gesamtumsatz von 517 Millionen US-Dollar, was einem Anstieg von 55 % im Vergleich zum Geschäftsjahr 2023 entspricht.
Zu den wichtigsten Entwicklungen gehören die Einreichung eines Antrags auf Biologics-Lizenz (BLA) für den bildgebenden Kandidaten TLX250-CDx bei Nierenkrebs, die FDA-Prioritätsprüfung für das bildgebende Mittel TLX101-CDx bei Hirnkrebs mit einem PDUFA-Datum vom 26. April 2025 sowie Fortschritte in therapeutischen Programmen, darunter Prostatakrebs (TLX591), Nierenkrebs (TLX250) und Glioblastom (TLX101). Das Unternehmen hat außerdem Vermögenswerte mit FAP-Ziel erworben und strategische Partnerschaften abgeschlossen, darunter eine Kooperation für KI-Bildgebung mit Subtle Medical.
Telix begann im November 2024 den Handel an der Nasdaq Global Select Market unter dem Symbol 'TLX' und behielt gleichzeitig seine ASX-Notierung bei.
- Q4 2024 revenue reached US$142M, up 46% YoY
- FY2024 revenue of US$517M exceeded guidance, showing 55% YoY growth
- FDA granted Priority Review for brain cancer imaging agent TLX101-CDx
- Successful Nasdaq listing expanding market access
- Strategic acquisition of FAP-targeting assets enhancing product pipeline
- R&D investments continue to impact expenses
- Regulatory delays in UK and Brazil market approvals
Insights
The Q4 2024 results demonstrate exceptional commercial execution with
The strong commercial performance of Illuccix in prostate cancer imaging continues to fund R&D investments while maintaining profitability. The dual-listing on Nasdaq enhances liquidity and access to capital markets, potentially leading to broader institutional ownership and improved valuation multiples.
Key catalysts for 2025 include multiple product launches, particularly TLX250-CDx (Zircaix) for kidney cancer imaging with potential H2 2025 launch and TLX101-CDx (Pixclara) with PDUFA date in April 2025. The FAP-targeting assets acquisition and ImaginAb platform technology deal significantly expand the pipeline value proposition.
The therapeutic pipeline progression shows remarkable momentum. The ProstACT GLOBAL trial for TLX591 nearing first interim readout in H1 2025 represents a pivotal milestone in prostate cancer therapy. The FDA engagement for TLX250 and TLX101 pivotal trials demonstrates regulatory pathway clarity for these promising assets.
The strategic acquisition of FAP-targeting assets is particularly noteworthy. FAP expression occurs across multiple cancer types, with initial focus on bladder cancer complementing Telix's urology franchise. The ImaginAb platform acquisition adds next-generation biologics capability, potentially revolutionizing radiopharmaceutical development.
The regulatory progress across multiple geographies (US, EU, UK, Brazil) for Illuccix and the AI partnership with Subtle Medical indicate strong commercial execution and innovation in diagnostic imaging. The integration of AI technology could significantly improve scanning efficiency and patient throughput.
MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024).
Sustained revenue growth
- Q4 2024 unaudited revenue of approximately US
$142 million (AU$218 million )1, represents an increase of46% over the prior year corresponding quarter (Q4 2023: US$97 million or AU$148 million ) and a quarter-over-quarter increase of5% (Q3 2024: US$135 million or AU$201 million ). - Telix’s revenue is currently generated predominantly from sales of Illuccix®, its diagnostic radiopharmaceutical for prostate cancer PET2 imaging.
Full year guidance exceeded
- Total FY2024 unaudited revenue is approximately US
$517 million (AU$783 million ) exceeding previously stated guidance of US$490 million to US$510 million (AU$745 million to AU$776 million ), representing a55% increase over FY2023. - FY2024 investment into research and development (R&D) remains in line with guidance, funded by earnings generated from product sales.
- The Company intends to provide FY2025 guidance when it reports audited FY2024 annual results on 20 February 2025.
Q4 2024 business update
Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer, Telix, said, “This has been another great quarter of commercial performance. Strong sales of Illuccix have led Telix to close out the year with revenue above guidance, while significantly progressing our strategic priorities. Boosting our balance sheet and the Nasdaq listing were major corporate milestones. The acquisition of FAP-targeting assets is a major addition to our superb product pipeline. We are well-positioned for significant expansion, including planned launches of multiple imaging products in key markets and advancing late-stage therapeutic assets into pivotal trials. 2025 is shaping up to be transformative year for Telix.”
Therapeutics Business
- Prostate cancer therapy candidate, TLX591 (177Lu-rosapatamab): During Q4 2024 Telix progressed ProstACT GLOBAL, the registrational clinical trial for Telix’s lead clinical therapeutic asset with first interim read out expected in H1 2025.
- Kidney cancer therapy candidate, TLX250 (177Lu-girentuximab): The Company was granted a pre-investigational new drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in Q4 2024, to discuss a proposed Telix-sponsored pivotal trial of TLX250.
- Glioblastoma therapy candidate, TLX101 (131I-iodofalan, or 131I-IPA): During Q4 2024, the Company held a pre-IND meeting with the FDA to discuss the design of a pivotal trial for TLX101. Based on positive feedback from the meeting, Telix will move forward with an IND submission in H1 2025.
- Fibroblast Activation Protein (FAP) targeting therapy candidate, TLX400: Telix entered into asset purchase and exclusive worldwide in-license agreements for a suite of clinically validated assets targeting FAP. FAP is one of the most promising pan-cancer targets, with an initial focus on bladder cancer rounding out Telix’s leading urology theranostics franchise.
- Proprietary engineered antibody platform and pipeline: Today, Telix announced it has entered into a transaction with ImaginAb Inc. to acquire a groundbreaking platform technology and drug discovery capability, along with a pipeline of next-generation biologic-based therapeutic candidates with significant potential to deliver future innovation in radiopharmaceuticals3.
Precision Medicine Business
- Kidney cancer imaging, TLX250-CDx (Zircaix®4, 89Zr-girentuximab): Telix submitted a Biologics License Application (BLA) for its renal cancer imaging candidate on 27 December 2024 and continues to target a U.S. commercial launch in H2 20255.
- Brain cancer imaging, TLX101-CDx, (Pixclara®4, 18F-floretyrosine or 18F-FET): The FDA formally accepted Telix’s New Drug Application (NDA), granted a Priority Review and provided a PDUFA6 goal date of 26 April 2025.
- Illuccix® global regulatory submissions: The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM) is expected to provide its decision on the Company’s EU marketing authorization application on 15 January 2025. In the United Kingdom (UK), the Company has responded to all queries with no substantive issues raised. The UK regulator (the Medicines and Healthcare products Regulatory Agency - MHRA) is experiencing significant administrative delays but an approval decision is expected this month. The Brazilian Health Regulatory Agency (ANVISA) is expected to provide a decision imminently after protracted administrative delays also unrelated to Telix’s marketing authorization application.
- MedTech partnership with Subtle Medical: Telix has concluded a partnership with California-based Subtle Medical, Inc. for artificial intelligence (AI)-powered PET imaging with Illuccix7. This technology enhances scanning workflow, increasing scanner throughput and capacity.
- Scintimun®: Today, Telix announced that it has entered into an agreement with Curium Pharma for the transfer of marketing and distribution rights for Scintimun® (99mTc-besilesomab, also known as TLX66-CDx)8. Scintimun is approved in 33 countries to image infection (osteomyelitis), with significant clinical indication expansion and theranostic potential.
Telix Manufacturing Solutions (TMS)
- RLS (USA) Inc acquisition: During Q4 2024, Telix progressed integration planning and expects to close the transaction in the first quarter of 20259.
- Brussels South production facility buildout: Telix completed the installation of two new cyclotrons at its facility in Brussels South, Belgium, facilitating the production of radioisotopes and patient doses on-site from 202510. Formal Good Manufacturing Practice (GMP) accreditation for the facility is expected imminently.
Corporate milestones
- On 14 November 2024, Telix American Depository Shares (ADSs) commenced trading on the Nasdaq Global Select Market (Nasdaq) under the symbol ‘TLX’11. Telix continues to maintain its primary listing on the Australian Securities Exchange (ASX).
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), Canada, 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) and the Nasdaq Global Select Market (Nasdaq: 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 FDA12, the Australian Therapeutic Goods Administration (TGA)13, and Health Canada14. No other Telix product has received a marketing authorization in any jurisdiction.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, 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 Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, 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, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, 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”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words 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’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 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; the anticipated benefits of Telix’s acquisitions; 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.
©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix®, Gozellix®4, Pixclara®4, Scintimun® and Zircaix®4 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
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1 Total revenue for Q4 2024 and year-to-date (FY2024) is provided on an unaudited basis. Conversion to AU$ is at an average exchange rate realized during Q4 2024 of AU
2 Positron emission tomography.
3 Telix ASX disclosure 13 January 2025.
4 Brand name subject to final regulatory approval.
5 The 27 December 2024 BLA submission to the FDA is intended to remediate a filing issue with the initial BLA submission from June 2024. See Telix ASX disclosures 31 July 2024 and 30 December 2024.
6 Prescription Drug User Fee Act.
7 Telix media release 30 October 2024.
8 Telix media release 13 January 2025.
9 Telix ASX disclosure 23 September 2024.
10 Telix media release 19 December 2024.
11 Telix ASX disclosure 14 November 2024.
12 Telix ASX disclosure 20 December 2021.
13 Telix ASX disclosure 2 November 2021.
14 Telix ASX disclosure 14 October 2022.
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