Telix Reports Third Quarter 2026 Financial Performance

MELBOURNE, Australia and INDIANAPOLIS, Oct. 21, 2026 /PRNewswire/ — Telix Prescribed drugs Restricted (ASX: TLX, NASDAQ: TLX, “Telix”) gives a monetary replace on its industrial and operational efficiency for the quarter ended September 30, 2026 (Q3 2026).

Q3 2026 Highlights^[1]

• Group income of US$245 million elevated 19% over the prior corresponding quarter (Q3 2025) pushed by continued sturdy demand for the industrial portfolio, in keeping with expectations. September gross sales drove the next quarterly exit fee indicating continued energy in underlying demand for Telix’s PSMA merchandise.
• Precision Drugs income of US$201 million, elevated 30% over the prior corresponding quarter, pushed by each Gozellix® and Illuccix®^[2]. Telix’s industrial PSMA-PET imaging^[3] portfolio continued to strengthen its market place, pushed by sturdy demand for our clinically differentiated merchandise.
• U.S. Meals and Drug Administration (FDA) authorised Pixclara®^[4] for glioma imaging, marking a big milestone and establishing the primary authorised imaging agent for this indication within the U.S.^[5]. The primary industrial doses had been administered in September 2026^[6].
• BiPASS®, a Section 3 examine evaluating pre-biopsy prostate most cancers detection, accomplished enrollment^[7], with the FDA supporting an NDA pathway and granting Quick Monitor Designation^[8].
• Telix introduced a merger with Isotope Applied sciences Munich SE (ITM). The merger creates a number one radiopharmaceutical platform with one of many {industry}’s broadest therapeutics pipelines, supported by best-in-class isotope manufacturing, manufacturing, and provide chain capabilities^[9].
• Telix reaffirmed that FY 2026 income and different revenue is anticipated to be in extra of US$1 billion, with income monitoring in keeping with higher finish of FY 2026 steerage of US$950 million to US$970 million plus US$40 million of different revenue. The Firm has additionally revised its FY 2026 R&D expenditure steerage vary to US$240 million to US$260 million.

Q3 2026 Income

Government Commentary

Dr. Christian Behrenbruch, Managing Director and Group CEO, said, “Demand for each Gozellix and Illuccix remained sturdy through the quarter, with U.S. dose volumes rising 1% quarter-over-quarter, in keeping with our expectations and reflecting anticipated summer time seasonality. We’re happy by the sturdy September exit run fee, supporting our confidence in delivering over 25% Precision Drugs income development in 2026. We achieved an necessary milestone with the FDA approval of Pixclara, increasing our industrial portfolio, establishing a presence in neuro-oncology and additional diversifying our income base. In the course of the quarter, we introduced a transformative merger with ITM, creating a number one vertically built-in radiopharmaceutical firm with one of many {industry}’s broadest therapeutic pipelines and expanded isotope manufacturing and world manufacturing capabilities. That is aligned with our long-term development technique reinforcing our potential to reliably serve sufferers at scale.”

Therapeutics Enterprise Unit

• TLX591-Tx (¹⁷⁷Lu rosopatamab tetraxetan): Following FDA overview and alignment of the Half 1 security knowledge, Telix is finalizing its IND modification to the FDA to help development to Half 2 of the ProstACT World Section 3 examine within the U.S.^[12]. Outdoors the U.S., Half 2 of the worldwide examine continues to enroll sufferers throughout seven nations: Australia, New Zealand, Canada, Türkiye, the UK, Singapore, and South Korea. Regulatory approvals have additionally been obtained to proceed in China and Japan^[13].
• TLX597-Tx (¹⁷⁷Lu-DOTA-HYNIC-panPSMA): OPTIMAL-PSMA^[14], a Section 2 examine evaluating TLX597-Tx in metastatic androgen pathway modulator-resistant (mAPMR) prostate most cancers^[15],  accomplished enrollment of 120 sufferers^[16]. A knowledge readout is anticipated within the first half of 2027. OPTIMAL-e^[17], a Section 2 examine evaluating TLX597-Tx in metastatic androgen pathway modulator-naive or -sensitive (mAPMN/S) prostate most cancers^[18], continues to display sturdy enrollment momentum.
• TLX250-Tx (¹⁷⁷Lu girentuximab tetraxetan): Continued enrollment of sufferers in LUTEON^[19], a pivotal trial of TLX250-Tx in superior clear cell Renal Cell Carcinoma (ccRCC). The trial is evaluating the protection and efficacy of TLX250-Tx in contrast with the investigator’s selection of monotherapy according to commonplace of care.
• TLX101-Tx (iodofalan ¹³¹I): Following full enrollment of the primary cohort in Half 1 of the Section 3 IPAX BrIGHT examine^[20], an IND modification was filed with the FDA to help enlargement of the trial into Half 1b within the U.S. IPAX-2^[21], a Section 1 examine of TLX101-Tx in sufferers with newly identified glioblastoma met its major endpoint, establishing a most tolerated dose (MTD) of two 5 GBq cycles together with commonplace of care. No dose-limiting toxicities had been noticed, supporting development of IPAX-2 to Section 2^[22].

Precision Drugs Enterprise Unit

⁶⁸Ga-PSMA-11 for prostate most cancers imaging:

• BiPASS®, a Section 3 examine of ⁶⁸Ga-PSMA-11 PET together with MRI for the analysis of prostate most cancers within the pre-biopsy setting, accomplished enrollment of 350 sufferers. Fast enrollment underscores the unmet want for a minimally invasive choice for prostate most cancers analysis. The examine builds on the medical basis established by the PRIMARY^[23] and PRIMARY2^[24] research and is meant to help regulatory submissions. The FDA has supported an NDA pathway that might facilitate reimbursement and granted Quick Monitor Designation, which can allow an expedited overview.
• With enrollment full within the Section 3 registrational examine of TLX591-Px (Illuccix) in Japan^[25], Telix is making ready for NDA submission and potential market entry. A Conditional Approval is at present beneath overview by Japan’s Pharmaceutical and Medical Gadgets Company (PMDA) and is anticipated to facilitate an expedited overview course of.

TLX101-Px (floretyrosine F 18) for mind most cancers imaging:

• Telix’s Advertising and marketing Authorization Utility (MAA) for Pixlumi®^[26] in Europe stays beneath overview.
• Following the FDA clearance of the IND software, Telix is advancing a Section 3 registrational examine to help enlargement of the Pixclara label for the analysis of mind metastases.

TLX250-Px, Zircaix®^[27] (⁸⁹Zr-girentuximab senvedoxam) for kidney most cancers imaging:

• Following receipt of the corrected Full Response Letter (CRL), Telix is finalizing its Biologics License Utility (BLA) resubmission package deal, addressing the remaining third-party manufacturing observations. Resubmission to the FDA is deliberate within the close to time period and stays a high precedence for the Firm in 2026.

Telix Manufacturing Options (TMS)

• By means of RLS, Telix has established a rising community of micro-pharmacy websites, often known as UroOncRx^TM, offering urologists with onsite entry to our imaging brokers, significantly in underserved and distant markets. A number of websites at the moment are operational and dishing out product, additional strengthening our radiopharmacy infrastructure and increasing affected person entry.
• ARTMS, a Telix firm, has secured contracts for 50 QUANTM® Irradiation Programs (QIS®) globally, reaching a key industrial milestone and reflecting continued demand for its isotope manufacturing know-how.
• Telix introduced a collaboration with Ekalia^[28], a three way partnership between IBA (Ion Beam Purposes S.A., EURONEXT) and Framatome, to advance scalable U.S. manufacturing of astatine-211 (²¹¹At), an alpha-emitting radioisotope being investigated for focused alpha remedy. The primary IBA alpha-beam cyclotron set up at Telix’s RLS Radiopharmacies website in Trevose close to Philadelphia (PA) is meant to determine a reproducible manufacturing mannequin, with the potential for additional rollout throughout the RLS community as demand develops. The collaboration secures long-term, precedence isotope entry for Telix’s alpha remedy pipeline, whereas additionally supporting third-party educational and {industry} packages.

Company Updates

• Telix introduced a transformational merger with ITM, the world’s main provider of therapeutic radioisotopes, reinforcing its long-term technique as a vertically built-in radiopharmaceutical firm and additional strengthening one of many {industry}’s broadest therapeutic pipelines. ITM brings a complementary late-stage portfolio led by ITM-11 (¹⁷⁷Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), in addition to industry-leading isotope capabilities anchored by the one globally scaled commercial-grade ¹⁷⁷Lu manufacturing platform. The transaction consists of upfront consideration of US$1.65 billion on a cash-free, debt-free foundation, with ITM shareholders anticipated to obtain roughly US$1.25 billion in Telix shares launched as ADRs. Extra contingent consideration of as much as US$700 million could also be paid upon achievement of future regulatory approvals and industrial gross sales milestones for ITM-11. The transaction stays topic to Telix shareholder approval and customary closing circumstances. A Normal Assembly of Shareholders is anticipated to be held on December 1, 2026 (AEDT).
• Mr. David Gill was appointed Chair of the Board on September 1, 2026^[29]. Mr. Gill is a life sciences government with greater than 35 years of expertise in biopharma, radiopharmaceuticals and medical units. He has held senior management positions, together with President, Chief Working Officer and Chief Monetary Officer roles at a number of public corporations, and brings intensive experience in capital markets, governance, enterprise scaling and company technique. He at present serves on the boards of a number of healthcare corporations and holds levels from Wake Forest College and Emory College.
• Mr. Marcin Firek will be a part of Telix as Firm Secretary, efficient October 21, 2026. Mr. Firek brings intensive expertise in company governance, authorized affairs, threat administration and public firm administration, together with for dual-listed Australian and U.S. corporations. Most just lately, he served as Head of Enterprise & Operational Danger at PwC Australia. Beforehand, he led the Firm Secretary staff at Woolworths Group Restricted, ASX Restricted and James Hardie Industries Plc. Earlier in his profession, he practiced company and M&A legislation at MinterEllison. Mr. Firek would be the major particular person accountable for communications with the ASX beneath ASX Itemizing Rule 12.6. Mr. Shomalin Naidoo has additionally ceased his appointment as interim Firm Secretary efficient at this time.

FY 2026 steerage

• Telix expects FY 2026 income and different revenue to exceed US$1 billion, with income monitoring towards the higher finish of its FY 2026 steerage of US$950 million to US$970 million, together with US$40 million in different reported revenue.
• Income steerage displays product gross sales in markets the place advertising authorization has been granted, features a full-year contribution from RLS, and incorporates anticipated gross sales of Pixclara.
• Telix revises its FY 2026 R&D expenditure steerage vary to US$240 million to US$260 million, beforehand US$230 million to US$270 million, topic to the achievement of deliberate medical, regulatory and improvement milestones.

About Telix Prescribed drugs Restricted

Telix Prescribed drugs (ASX: TLX, NASDAQ: TLX) is a commercial-stage world radiopharmaceutical firm, advancing focused theranostics to enhance outcomes for folks with most cancers throughout the affected person journey. Theranostics pairs a precision diagnostic with a focused remedy to each diagnose and deal with illness.

Telix’s industrial franchise is anchored by its precision diagnostics portfolio: Illuccix® (package for the preparation of gallium-68 gozetotide injection), commercially accessible in 22 nations together with the U.S., Gozellix® (package for the preparation of gallium-68 gozetotide injection), authorised by the U.S. FDA, and Pixclara® (floretyrosine F 18) authorised by the FDA for glioma imaging. The Firm’s late-stage therapeutic pipeline consists of three investigational belongings in pivotal-stage trials: TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan) in prostate most cancers, TLX101-Tx (iodofalan ¹³¹I) in recurrent glioblastoma, and TLX250-Tx (lutetium (¹⁷⁷Lu) girentuximab tetraxetan) in kidney most cancers, moreover complemented by a deep pipeline of subsequent era candidates.

Telix is headquartered in Melbourne, Australia, with operations throughout North America, Europe, Latin America and Asia-Pacific. For extra info, go to www.telixpharma.com or observe Telix on LinkedIn, X and Fb.

This announcement has been approved for launch by the Telix Prescribed drugs Restricted Board of Administrators.

Steering Disclaimer

The said income steerage relies on anticipated world and home financial circumstances and is topic to recognized and unknown dangers, uncertainties and different components that will trigger our precise outcomes to vary materially. As such, buyers are cautioned to not place undue reliance on this steerage and specifically Telix can not assure a specific end result. In compiling monetary forecasts, quite a lot of key variables that will have a big influence on steerage have been recognized and are listed under.

Key variables that might trigger precise outcomes to vary materially embody: the success and timing of analysis and improvement actions; selections by regulatory authorities relating to approval of our merchandise in addition to their selections relating to label claims; aggressive developments affecting our merchandise; the power to efficiently market new and present merchandise; difficulties or delays in manufacturing; commerce shopping for patterns and fluctuations in curiosity and foreign money alternate charges; laws, regulation, or coverage that impacts product manufacturing, distribution, pricing, reimbursement, entry or tax; acquisitions and divestitures; analysis collaborations; litigation or authorities investigations; and Telix’s potential to guard its patents and different mental property. See the Authorized Notices part under for extra info, dangers and assumptions.

Authorized Notices

Cautionary Assertion Relating to Ahead-Wanting Statements. 

You must learn this announcement along with our threat components, as disclosed in our most just lately filed reviews with the Australian Securities Trade (ASX), U.S. Securities and Trade Fee (SEC), together with our Annual Report on Type 20-F filed with the SEC, or on our web site.

The data contained on this announcement just isn’t meant to be a proposal for subscription, invitation or suggestion with respect to securities of Telix Prescribed drugs Restricted (Telix) in any jurisdiction, together with america. The data and opinions contained on this announcement are topic to alter with out notification. To the utmost extent permitted by legislation, Telix disclaims any obligation or endeavor to replace or revise any info or opinions contained on this announcement, together with any forward-looking statements (as referred to under), whether or not because of new info, future developments, a change in expectations or assumptions, or in any other case. No illustration or guarantee, categorical or implied, is made in relation to the accuracy or completeness of the knowledge contained or opinions expressed in the midst of this announcement.

This announcement might comprise forward-looking statements, together with inside the that means of the U.S. Personal Securities Litigation Reform Act of 1995, that relate to anticipated future occasions, monetary efficiency, plans, methods or enterprise developments. Ahead-looking statements can typically be recognized by way of phrases equivalent to “might”, “count on”, “intend”, “plan”, “estimate”, “anticipate”, “consider”, “outlook”, “forecast” and “steerage”, or the unfavourable of those phrases or different related phrases or expressions. Ahead-looking statements contain recognized and unknown dangers, uncertainties and different components that will trigger our precise outcomes, ranges of exercise, efficiency or achievements to vary materially from any future outcomes, ranges of exercise, efficiency or achievements expressed or implied by these forward-looking statements. Ahead-looking statements are based mostly on Telix’s good-faith assumptions as to the monetary, market, regulatory and different dangers and issues that exist and have an effect on Telix’s enterprise and operations sooner or later and there may be no assurance that any of the assumptions will show to be right. Within the context of Telix’s enterprise, forward-looking statements might embody, however should not restricted to, statements about: the initiation, timing, progress, completion and outcomes of Telix’s preclinical and medical trials, and Telix’s analysis and improvement packages; Telix’s potential to advance product candidates into, enroll and efficiently full, medical research, together with multi-national medical trials; the timing or chance of regulatory filings and approvals for Telix’s product candidates, together with TLX101-Px and TLX250-Px, manufacturing actions and product advertising actions; Telix’s gross sales, advertising and distribution and manufacturing capabilities and methods; the commercialization of Telix’s product candidates, if or after they have been authorised; Telix’s potential to acquire an sufficient provide of uncooked supplies at cheap prices for its merchandise and product candidates; estimates of Telix’s bills, future revenues and capital necessities; Telix’s monetary efficiency; developments regarding Telix’s rivals and {industry}; the anticipated influence of U.S. and international tariffs and different macroeconomic circumstances on Telix’s enterprise, together with because of battle or different geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they’ve been authorised. Telix’s precise outcomes, efficiency or achievements could also be materially completely different from these which can be expressed or implied by such statements, and the variations could also be hostile. Accordingly, you shouldn’t place undue reliance on these forward-looking statements.

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