TLX

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved 22% year-on-year revenue growth to $477 million in H1 2026, driven by robust demand for Illuccix and the successful launch of Gozellix. Management attributes commercial success to a 'two-product strategy' that addresses distinct customer segments and economics, resulting in 16 consecutive quarters of unit and revenue share growth. The RLS acquisition has transitioned into a strategic pillar, now serving as the second-largest distributor of Telix products while maintaining a stable third-party revenue stream. Operational focus has shifted toward building a scalable, just-in-time manufacturing infrastructure, including clean room expansions and cyclotron installations to support future therapeutic delivery. Strategic positioning is defined by a 'modality agnostic' approach, prioritizing disease biology over specific platforms, exemplified by the Regeneron collaboration in biologics and antibody engineering. The Precision Medicine business is explicitly utilized as a capital engine, generating $153 million in commercial profit to fund high-value R&D and therapeutic pipeline acceleration. Maintained full-year 2026 revenue guidance of $950 million to $970 million, with management expecting to land at the upper end of the range based on current momentum. R&D guidance was increased to $230 million–$270 million to accelerate Phase III therapeutic candidates and the Regeneron collaboration initiatives. Anticipated U.S. launch of Pixclara following the September 11 PDUFA date, targeting brain metastases as a significant expansion beyond the initial indication. The BiPASS Phase III study is positioned as a 'market doubler' with the potential to move PSMA imaging from staging to initial diagnosis, potentially displacing invasive biopsies. Resubmission of the Zircaix BLA is prioritized for the next one to two months, focusing on resolving third-party manufacturing deficiencies identified in the FDA's complete response letter. Management addressed the Zircaix 'corrected' CRL as an administrative matter on the FDA's side, clarifying that no additional actions or data requirements were triggered beyond the original deficiencies. The BiPASS trial recruitment target was increased not solely for statistical powering, but to accommodate a significant backlog of patients following rapid site onboarding and high physician interest. Refinancing of convertible bonds successfully increased the cash balance to $252 million, providing the financial capacity to support late-stage clinical trials without immediate dilution. Astatine-based alpha therapy candidates (TLX101 and TLX592) are being positioned as sequential treatments to follow beta therapies in the therapeutic cascade for advanced disease states. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management views TruVu primarily as a manufacturing improvement rather than a segmented market strategy, expecting minimal impact on Telix's current trajectory. Reiterated that the Telix two-product strategy (Illuccix/Gozellix) remains the most pragmatic approach to managing diverse customer segments. The study aims to halve the number of unnecessary prostate biopsies by identifying patients who do not have clinically significant cancer. For patients who still require a biopsy, the goal is to shift from 12-20 needle template biopsies to a single targeted, image-guided biopsy ('none and done' or 'one and done'). Management defended the use of biologics/antibodies, noting that academic prejudice against them is often driven by budget constraints rather than pharmacological data. Emphasized that antibodies offer long tumor retention and limited radiation to healthy organs, making them ideal for combination therapies with standard-of-care backbones. Telix has fully aligned with the FDA on the protocol for Part 2 and The company expects to file the IND amendment following a final courtesy meeting with the FDA in a couple of weeks. The primary focus is activating U.S. sites this year, with broader European expansion to follow once the U.S. regulatory hump is cleared.

This article first appeared on GuruFocus. Revenue: $477 million, up 22% year-on-year. EBITDA: $52 million, up 146% year-on-year. Net Profit After Tax: $38 million, up 30% year-on-year. Precision Medicine Revenue: Approximately $390 million, up 27% year-on-year. Precision Medicine Gross Margin: 65%, up 1% year-on-year. Consolidated Gross Margin: 55%, up 2% year-on-year. R&D Investment: Represented 26% of revenue. Cash Balance: $252 million. TMS Third-Party Revenue: $89 million, up 10% year-on-year. TMS Internal Revenue: $57 million, up 70% year-on-year. Precision Medicine EBITDA: $132 million, up 26% year-on-year. Q2 Precision Medicine Revenue: $202 million, up 9% quarter-over-quarter. Q1 Precision Medicine Revenue: $186 million, up 16% quarter-over-quarter. Full-Year Revenue Guidance: Maintained at $950 million to $970 million, expected to land at the upper end. R&D Guidance: Updated to $230 million to $270 million. Warning! GuruFocus has detected 7 Warning Signs with TLPPF. Is TLPPF fairly valued? Test your thesis with our free DCF calculator. Release Date: August 19, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Telix Pharmaceuticals Ltd (TLPPF) delivered strong financial results with revenue up 22% year-on-year to $477 million and EBITDA improving 146% to $52 million. The Precision Medicine business saw robust growth of 27% year-on-year, driven by successful launches of Gozellix and continued strength of Illuccix, with market share increasing for 16 consecutive quarters. Regulatory progress is on track with Pixclara assigned a PDUFA date of September 11, 2026, and submissions completed for Pixclara and Pixlumi in both the US and Europe. The BiPASS Phase 3 study, which could potentially double the PSMA imaging market, is close to completing targeted enrollment, with strong physician enthusiasm and rapid recruitment. The company maintains a strong cash position of $252 million after refinancing convertible bonds on better terms, providing financial capacity to accelerate growth. Telix Pharmaceuticals Ltd (TLPPF) is advancing a diversified therapeutic pipeline with three Phase 3 candidates, including ProstACT Global, IPAX BrIGHT, and LUTEON, and has a strategic collaboration with Regeneron for next-generation alpha therapies. International expansion is progressing well, with NDA submissions in China and Japan, and the company is building infrastructure for future therapeutic launches. Zircaix received a corrected Complete Response Letter from the FDA, and the resubmission process is still ongoing, with no definitive timeline for approval. The company maintains conservative full-year revenue guidance of $950-$970 million despite strong performance, suggesting potential headwinds or uncertainty in the second half. R&D investment increased significantly, representing 26% of revenue, which may pressure near-term profitability despite strong commercial performance. The PSMA imaging market is estimated to be nearly two-thirds penetrated, limiting future growth potential in the core diagnostic segment. Competitive threats loom with Lantheus's TruVu product receiving a reimbursement code, which could impact market share dynamics in the PSMA imaging space. The company faces regulatory delays and administrative issues with the FDA, as seen with the Zircaix CRL, which could affect investor confidence. The BiPASS trial's statistical powering was increased, raising questions about the robustness of the study design and potential challenges in meeting endpoints. Q: Regarding Zircaix, you mentioned the resubmission is tracking against agreed timelines. How much of the resubmission process is within your control, and is it correct to assume the resubmission should occur in the next month or two?A: Christian Behrenbruch (Group CEO): All of it is within our control. It would be a reasonable assumption that the resubmission will occur in the next month or two. The extension granted by the FDA is unconnected to the corrected CRL, which was an administrative matter on the FDA's side. There are no restrictions preventing flexibility on the resubmission date. Q: Can you provide an update on the BiPASS trial, specifically regarding the increased target recruitment and the motivation behind it?A: Kevin Richardson (Precision Medicine CEO): The increase was not solely about statistical powering. The trial experienced massive uptake and rapid site onboarding, essentially recruiting in five months. We elected to fulfill the patient backlog. David Cade (CMO) added that the design was a collaborative dialogue with the FDA, building on the PRIMARY and PRIMARY 2 studies with agreed endpoints and a statistical analysis plan intended to support a regulatory filing. Q: Given the upcoming reimbursement code for TruVu, how do you expect market share development to progress through the balance of the year?A: Christian Behrenbruch (Group CEO): We don't expect a huge impact. TruVu is positioned as a manufacturing improvement and will be rolled out across all market segments, unlike our two-product strategy with Gozellix and Illuccix. We have not modified our guidance, which bakes in a realistic outcome. Kevin Richardson (Precision Medicine CEO) added that they see it as a similar product and will continue their successful two-product strategy. Q: Can you provide early feedback from physicians on the BiPASS study and what successful outcomes would look like?A: David Cade (CMO): We were pleasantly surprised by the enrollment rate. The Melbourne site almost completed the study by itself, demonstrating significant physician desire to add PSMA PET imaging on top of MRI. Physicians believe it furnishes more useful information about whether to biopsy, what type of biopsy to do, and allows for more certain treatment planning. The rapid enrollment reflects investigators' confidence in the asset's clinical performance. Q: If BiPASS is successful, what label claim do you expect to ask for, and how do you see it being used, particularly regarding PI-RADS scores?A: Christian Behrenbruch (Group CEO): We don't give label guidance until negotiated, but the spirit is to guide decision-making around biopsy utilization. David Cade (CMO): We agreed with the FDA to enroll PI-RADS 1-4, not 5, but the FDA will consider the totality of data covering all scores. The goal is to halve the number of prostate biopsies while not missing clinically significant cancer, and shift from template biopsy to a single targeted image-guided biopsy"none and done" or "one and done." Q: Can you comment on the animated discussion at ASCO regarding antibody modality, and how the Lantheus/Curium merger might affect your strategy?A: Christian Behrenbruch (Group CEO): Data speaks for itself, and the rebuttal from the floor was vibrant. Nuclear medicine has a history of budget-conscious academic environments where experimenting with biologics isn't possible, leading to prejudice not driven by data. We invest based on pharmacology and payload delivery. Regarding the merger, we see it as business as usual; it's mystifying why one would acquire a company with such a flat growth outlook compared to our 22% growth. Q: Can you provide an update on the ProstACT Global trial progress, specifically regarding the IND amendment and European submissions?A: Christian Behrenbruch (Group CEO): The FDA review was treated as an End-of-Part 1 meeting. We have one more engagement with the FDA in a couple of weeks, after which we'll file the IND amendment. Our priority is getting US patients into the study this year. European jurisdictions like the UK and Turkey are already in the study, and we'll add more European countries once the FDA submission is complete. Q: You maintained revenue guidance of $950-$970 million but noted tracking to the upper end. Is this conservatism, or are you factoring in seasonality or the TruVu launch?A: Christian Behrenbruch (Group CEO): We've given guidance, and we're maintaining our guidance. The strength in Q2, particularly in the PSMA PET franchise, supports the upper end, but we remain committed to the stated range without an upgrade at this time. Q: What are the next steps for TLX597 after the OPTIMAL-PSMA and OPTIMAL-e trials?A: Christian Behrenbruch (Group CEO): We're waiting for the first chunk of data to read out. Our priority is completing recruitment for TLX591, our flagship program. Once we have the Phase 2 data in hand, it will be the catalyst to inform the market about our longer-term plans for TLX597. Q: Can you provide an update on the Pixlumi timeline for the Marketing Authorization Application in Europe?A: Christian Behrenbruch (Group CEO): We haven't given updated timelines due to potential clock stops during review. The standardized process is around 18 months from submission. We don't expect major issues as the package was already reviewed by a major regulator, giving us high confidence in the submission. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

MELBOURNE, Australia and INDIANAPOLIS, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces its financial results for the period ended June 30, 2026. H1 2026 key results Group performance1: Double-digit revenue growth and gross margin improvement Group revenue of US$477 million, up 22%2 year-over-year, tracking in line with the upper end of full year guidance of US$950 million to US$970 million. Group gross margin of 55%, up 2% year-over-year, Precision Medicine gross margin of 65%, up 1% year-over-year, reflecting solid commercial performance, a favorable product mix and operational efficiencies. Adjusted EBITDA3 of US$52 million, up 146% year-over-year reflecting strong demand across our product portfolio and initial non-refundable payment of US$40 million from Regeneron collaboration4. Research & Development (R&D) investment of US$124 million, primarily directed toward advancing late-stage therapeutic and precision medicine programs, supporting the Company's strategy to build diversified revenue streams. Entered into strategic collaboration with Regeneron to jointly develop and commercialize next generation radiopharmaceutical therapies4. Completed refinancing of existing convertible bond structure, issuing US$600 million of new convertible bonds due 20315. Profit after tax of US$38 million includes US$40 million of other income received from Regeneron and finance costs of US$19 million, predominately related to refinancing of the convertible bonds. Generated positive operating cash flow of US$23 million and maintained a cash balance of US$252 million as of June 30, 2026. Executive commentary Managing Director and Group CEO, Dr. Christian Behrenbruch, stated: “Telix delivered an outstanding first half, with strong revenue growth, market share gains and significant progress across clinical and regulatory milestones. Our strengthened balance sheet is enabling increased investment in late-stage programs, including ProstACT Global, market expansion opportunities within our precision medicine portfolio and manufacturing and supply chain capabilities that differentiate Telix. With multiple near-term catalysts, we enter the second half with strong momentum and confidence.” Segment results Telix Precision Medicine: Strong volume growth of Illuccix® and Gozellix® Precision Medicine segment revenue up by 27% year-over-year reflecting continued success of Telix’s two product strategy, with Illuccix® and Gozellix® delivering growth in sales volumes and market share gains. Gross margin of 65% up 1% year-over-year. Adjusted (segment) EBITDA up by 26% year-over-year to US$132 million. Patient enrollment nearing completion for Phase 3 BiPASS™ study of Illuccix and Gozellix for prostate cancer imaging in the pre-biopsy setting. Illuccix Japan Phase 3 registrational study enrollment completion6. New drug application (NDA) for Illuccix accepted and under review by the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE)7. TLX101-Px, (floretyrosine F 18) for glioma (brain cancer) imaging: TLX250-Px, Zircaix®8 (zirconium-89 (89Zr) girentuximab senvedoxam) for kidney cancer imaging: Telix continues to make good progress toward near-term resubmission of its U.S. Biologics License Application (BLA). The Company has been granted an extension of the BLA resubmission deadline, following receipt of a corrected Complete Response Letter (CRL)12. Telix continues to work closely with the FDA to ensure the resubmission package comprehensively addresses all outstanding CRL items. Telix Therapeutics: Investment delivering significant advances across a number of key late-stage development programs Of the R&D investment, US$68 million was invested in the therapeutics pipeline. Milestones include: TLX591-Tx (lutetium (177Lu) rosopatamab tetraxetan): TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA): TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan): TLX101-Tx (iodofalan 131I): Telix Manufacturing Solutions (TMS): Expanding Telix’s global footprint to enable next phase of growth Telix continues to invest in its global infrastructure, expanding its TMS operations. The TMS segment includes RLS Radiopharmacies (RLS), IsoTherapeutics (U.S.), and production (and R&D) facilities in Sacramento (U.S.), Seneffe (Belgium), North Melbourne (Australia) and Yokohama (Japan), representing a significantly expanded global production and manufacturing footprint. TMS is central to Telix's long-term growth strategy and is expected to support increasing commercial demand and future pipeline expansion. TMS reported US$146 million total segment revenue, which includes US$89 million from third-party product sales and service fees, and US$58 million internal revenue20, reflecting growth in sales of Illuccix and Gozellix through the RLS network and contributing to Group gross margin improvement. TMS operating loss of US$33 million, includes US$10 million of depreciation and amortization on acquired intangibles. Adjusted EBITDA loss for the TMS segment of US$23 million (H1 2025: Adjusted EBITDA loss of US$13 million), driven by increased investment in supply chain and logistics functions to meet anticipated therapeutics infrastructure needs. Other TMS milestones in H1 2026 include: Guidance FY 2026 revenue and other income expected to be in excess of US$1 billion, with revenue progressing in line with upper end of FY 2026 guidance of US$950 million to US$970 million and US$40 million of other income received from Regeneron. Telix reaffirms R&D expenditure guidance of US$230 million to US$270 million, enabled by the Company’s strong commercial performance and initial payment of US$40 million received from Regeneron. Corporate update The Company advises that on August 20, 2026, it entered into an equity distribution agreement (EDA) with Morgan Stanley & Co. LLC and William Blair & Company, L.L.C. (together, the "Sales Agents") to establish an "at-the-market" (ATM) facility. Under the ATM facility, the Company may, from time to time, determine to offer and issue new fully paid ordinary shares ("Shares") at prevailing market prices in the form of American Depository Shares (ADSs). Each ADS represents one Share. The ATM facility will provide an opportunity to facilitate greater access to the Company’s securities on the Nasdaq stock exchange. The Company will control the offer process and has sole discretion over whether and when the ATM facility is used, the number of ADSs sold, and the minimum sale price of the ADSs. No offers or sales of ADSs will be made under the ATM facility unless and until a prospectus supplement has been filed with the U.S. Securities and Exchange Commission (SEC). The ATM facility will be subject to compliance with the ASX Listing Rules, including the Company’s available share placement capacity. Summary: Group financial results Investor call An investor webcast and conference call will be held at 9:00 a.m. AEST today, Thursday, August 20, 2026 (7:00 p.m. EDT Wednesday, August 19, 2026). Participants can register for the webcast via this link: https://s1.c-conf.com/diamondpass/10056417-pz2402.html About Telix Pharmaceuticals Limited Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA). The Company's late-stage therapeutic pipeline includes three investigational assets in pivotal-stage trials: TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (131I-iodofalan) in recurrent glioblastoma, and TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) in kidney cancer, additionally complemented by a deep pipeline of next generation candidates. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook. Investor Relations Annie Kasparian [email protected] Charlene [email protected] Guidance Disclaimer The stated 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 listed below. 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. This announcement has been authorized for release by the Telix Pharmaceuticals Limited Board of Directors No Offer or Solicitation This announcement does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities of the Company in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offers or sales of ADSs will be made under the EDA unless and until a prospectus supplement has been filed with the SEC. Telix has filed an automatic shelf registration statement on Form F-3ASR (File No. 333-293611) with the SEC, which became immediately effective upon filing. Any offering of securities in connection with the at-the-market offering will be made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. A prospectus supplement describing the terms of the at-the-market offering will be filed with the SEC prior to any sales of ADSs under the EDA. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained from: Morgan Stanley & Co. LLC Attention: Prospectus Department 180 Varick Street, 2nd Floor New York, NY 10014 and William Blair & Company, L.L.C. Attention: Prospectus Department 150 North Riverside Plaza Chicago, IL 60606 or by accessing the SEC's website at www.sec.gov. The at-the-market facility will be subject to the ASX Listing Rules framework for share issuances, including applicable placement and participation limits. 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 Annual Report 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, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including TLX101-Px and TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization 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 commercial 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 impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Forward-looking statements may also include statements about the timing and use of the at-the-market facility established under the EDA, the potential sale of ADSs therefrom, Telix's intentions regarding activation of the at-the-market facility, and the anticipated benefits of the at-the-market facility. 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. Non-IFRS Financial Measures. Telix’s results are reported under International Financial Reporting Standards (IFRS). This announcement includes various non-IFRS financial information to reflect its underlying performance, which have not been subject to audit or review. These non-IFRS measures include Adjusted EBITDA, which represents net earnings attributable to the Group excluding net finance costs, income tax expense, depreciation and amortization and other gains/(losses) (net). As required by SEC rules, we have provided reconciliations of these non-IFRS financial measures to the most directly comparable IFRS measures, which for Adjusted EBITDA, is Profit/(loss) before income tax. The Group believes that these non-IFRS measures, which are not considered to be a substitute for or superior to IFRS measures, provide stakeholders with additional useful information on the underlying trends, performance and position of the Group and are consistent with how business performance is measured internally. The non-IFRS measures are not defined by IFRS and therefore may not be directly comparable with other companies’ alternative performance measures. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 1 Group performance includes Telix Precision Medicine, Telix Therapeutics and Telix Manufacturing Solutions (TMS).2 All comparisons to H1 2025 results.3 Earnings before interest, tax, depreciation and amortization.4 Telix ASX disclosure April 13, 2026.5 Telix ASX disclosure April 14, 2026.6 Telix media release July 17, 2026. Japan Registry of Clinical Trials identifier: JRCT2031250473.7 Telix media release January 20, 2026.8 Launch and brand names subject to final regulatory approval. Zircaix (TLX250-Px, ccRCC imaging), Pixclara and Pixlumi (TLX101-Px, glioma imaging). 9 Prescription Drug User Fee Act.10 Telix ASX disclosure April 10, 2026.11 Telix media release May 1, 2026.12 Corrected CRL issued April 10, 2026.13 Telix ASX disclosure March 10, 2026.14 Telix ASX disclosure July 2, 2026.15 Telix LinkedIn June 25, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12625000971437. 16 Telix media release July 16, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12626000034336.17 Telix media release July 21, 2026. ClinicalTrials.gov ID: NCT07197580. Clear cell renal cell carcinoma.18 ClinicalTrials.gov ID: NCT07100730.19 ClinicalTrials.gov ID: NCT05450744.20 Inter-segment revenue is eliminated on consolidation, refer to note 3 of the Interim financial report lodged today with the ASX.21 Earnings before interest, tax, depreciation and amortization and other gains/(losses) (net).

Interested in Telix Pharmaceuticals Limited? Here are five stocks we like better. Strong first-half financial performance: Telix reported revenue of $477 million, up 22% year over year, while EBITDA surged 146% to $52 million and net profit reached $38 million. The company is tracking toward the upper end of its AUD 950 million–AUD 970 million full-year revenue guidance. Imaging portfolio continues expanding: Precision medicine sales rose 27% to approximately AUD 390 million, driven by Gozellix and Illuccix. Telix has launched or begun launching its PSMA imaging products in 24 countries, with further regulatory submissions and reviews underway in China, Japan, the U.S. and Europe. Pipeline advances support future growth: The Phase III BiPASS study is nearing its enrollment target and could significantly expand the PSMA imaging market if it reduces unnecessary prostate biopsies. Telix also progressed multiple therapeutic programs, including TLX591, TLX597 and TLX101, while increasing 2026 R&D guidance to AUD 230 million–AUD 270 million. Telix Pharmaceuticals (NASDAQ:TLX) reported first-half 2026 revenue of $477 million, up 22% from the prior-year period, as demand for its precision medicine imaging products continued to grow. The company said EBITDA increased 146% year over year to $52 million, while net profit after tax rose to $38 million. Managing Director and Group CEO Dr. Christian Behrenbruch said the company generated approximately AUD 390 million in precision medicine sales, a 27% increase from a year earlier, driven by the launch of Gozellix and continued growth in Illuccix. Telix said it is tracking toward the upper end of its full-year revenue guidance of AUD 950 million to AUD 970 million. → Looking Beyond CrowdStrike? 3 AI Security Stocks Stand Out Group CFO Darren Smith said Telix’s precision medicine business generated gross margins of 65%, up 1 percentage point year over year. Consolidated gross margin improved 2 percentage points to 55%, he said. The company increased its cash balance to $252 million following a refinancing of its convertible bonds. Smith said Telix is prioritizing reinvestment in development programs rather than maximizing near-term earnings. → 3 Robotics Stocks Under $10: Value, Momentum, or Bet? Research and development spending represented 26% of revenue in the first half. Telix updated its 2026 R&D guidance to AUD 230 million to AUD 270 million, citing additional investment in development programs and its collaboration with Regeneron. Precision medicine EBITDA rose 26% year over year to AUD 132 million. Telix Manufacturing Solutions, including RLS, generated AUD 89 million in third-party revenue, up 10% year over year. Internal revenue distributed through RLS increased 70% to AUD 57 million, making RLS Telix’s second-largest distributor of its products, according to Smith. Telix said it continues to invest in manufacturing and distribution capacity at facilities in Seneffe, Yokohama and selected RLS sites. The investments include clean-room capacity, cyclotrons and capabilities needed to dispense lutetium therapeutic drugs. → Michael Burry Is Betting Against Palantir Again—Should Investors Care? Kevin Richardson, CEO of Telix Precision Medicine, said the company’s prostate-specific membrane antigen, or PSMA, imaging portfolio has gained unit and revenue market share for 16 consecutive quarters. Revenue from the portfolio totaled $202 million in the second quarter, up 9% sequentially, following $186 million in the first quarter. Richardson said Telix’s two-product strategy, centered on Illuccix and Gozellix, was designed to serve different customer segments. He said the products’ clinical characteristics, service reliability, ordering process, pricing consistency and physician education efforts have supported adoption. Telix has launched or initiated launches of its PSMA portfolio in 24 countries. In China, the company submitted a new drug application earlier this year and is awaiting review by the National Medical Products Administration. In Japan, Telix completed enrollment of more than 100 patients in a registration-enabling study and is preparing an NDA submission while awaiting feedback regarding conditional approval. On the regulatory front, Telix said the U.S. Food and Drug Administration assigned a Sept. 11 PDUFA date for Pixclara, while the company has also submitted Pixlumi in Europe. Behrenbruch said the European review process generally takes about 18 months from submission, although timing can vary based on review periods and clock stops. For Zircaix, Telix received a corrected Complete Response Letter from the FDA and said it is finalizing a resubmission package, particularly addressing third-party manufacturing deficiencies. Behrenbruch said a resubmission in the next one to two months would be a reasonable assumption and that the timing is within the company’s control. Telix said its Phase III BiPASS study is close to completing targeted enrollment. The trial is evaluating the potential use of PSMA PET imaging before prostate biopsy, an application that Richardson said could approximately double the current PSMA imaging market if successful. The company said approximately 800,000 prostate biopsies are performed annually in the U.S., with roughly 75% producing negative results. Richardson said BiPASS could reduce unnecessary biopsies and improve confidence for patients who proceed to the procedure. Chief Medical Officer Dr. David Cade said the study enrolled rapidly, with approximately 350 patients recruited in about five months. He said early investigator experience indicated interest in using gallium PSMA PET imaging alongside MRI to inform whether a biopsy is needed and, when appropriate, what type of biopsy should be conducted. Cade said BiPASS enrolled patients with PI-RADS scores from 1 through 4, but not PI-RADS 5, under an agreement with the FDA. He described the program’s objective as potentially reducing the number of biopsies while maintaining detection of clinically significant prostate cancer. Telix said the FDA completed its safety review of Part 1 of the Phase III ProstACT Global study of TLX591 in metastatic castrate-resistant prostate cancer. The company said it has aligned with the FDA on the Part 2 protocol design and expects another FDA engagement before filing an amended investigational new drug application. The company is enrolling ProstACT Global patients in seven countries and plans to provide an update when an event-driven interim analysis of radiographic progression-free survival becomes available. The analysis requires 81 disease-progression events. Telix also said it has completed enrollment in the Phase II OPTIMAL-PSMA study of TLX597 in metastatic castrate-resistant prostate cancer and has begun dosing patients in the OPTIMAL-e study in metastatic hormone-sensitive prostate cancer. The company is also dosing patients in its Phase III IPAX-BrIGHT study of TLX101 plus lomustine in glioblastoma and in a renal cell carcinoma study involving a CAIX-targeting antibody therapy. Behrenbruch said Telix will host an R&D Day in New York on Sept. 22 to provide further detail on its pipeline and clinical data. Telix Pharmaceuticals (NASDAQ: TLX) is a clinical-stage biopharmaceutical company focused on the development and commercialization of molecularly targeted radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging expertise in radiochemistry, nuclear medicine and oncology, Telix aims to address unmet clinical needs across a range of tumor types by pairing diagnostic imaging agents with therapeutic radionuclides. The company’s pipeline spans both imaging and therapeutic candidates. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Telix Pharmaceuticals H1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

MELBOURNE, Australia and INDIANAPOLIS, July 31, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today advises that it will release its financial results for the half-year ended June 30, 2026 on Thursday August 20, 2026. An investor webcast and conference call will be held at 9:00 a.m. AEST on Thursday August 20, 2026 (7:00 p.m. EDT Wednesday August 19, 2026). Participants can register for the webcast or teleconference at the following link: https://s1.c-conf.com/diamondpass/10056417-pz2402.html About Telix Pharmaceuticals Limited Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA). The Company's late-stage therapeutic pipeline includes three investigational assets in pivotal-stage trials: TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (131I-iodofalan) in recurrent glioblastoma, and TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) in kidney cancer, additionally complemented by a deep pipeline of next generation candidates. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook. This announcement has been authorized for release by Telix Pharmaceuticals Limited's Company Secretary, Shomalin Naidoo. Legal Notices Cautionary Statement Regarding Forward-Looking Statements. 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 Annual Report 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, completion and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enroll 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 commercialization 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 impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business, including as a result of war or other geopolitical conflicts; 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. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 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Regeneron Pharmaceuticals reported past second-quarter 2026 results with revenue rising to US$4,290.7 million from US$3,675.6 million a year earlier, while net income slipped to US$1,296.9 million and diluted EPS from continuing operations softened to US$12.23. Alongside these mixed earnings, Regeneron recently entered a collaboration with Telix Pharmaceuticals to co-develop next-generation radiopharmaceutical oncology therapies, potentially broadening its precision-medicine footprint beyond its existing biologics franchise. We’ll now examine how Regeneron’s higher revenue but lower profitability this quarter may influence its investment narrative and future expectations. The future of work is here. Discover the 34 top robotics and automation stocks leading the charge in AI-driven automation and industrial transformation. To own Regeneron, you need to be comfortable with a story built around high-value biologics, ongoing R&D spend, and managing the drag from a maturing EYLEA franchise. The latest quarter’s higher revenue but softer earnings underscore how mix, pricing, and investment can pull in different directions, yet do not appear to change the central near term catalyst: how effectively Regeneron can defend and upgrade its ophthalmology business while offsetting competitive and pricing pressure on EYLEA. The Telix collaboration on radiopharmaceutical oncology fits neatly beside this, as it extends Regeneron’s oncology reach into precision radiotherapy rather than reshaping the near term profit picture. It looks more like a long term pipeline option that could complement existing biologics if it progresses, rather than a driver that alters current concerns around EYLEA competition, regulatory timing, and margin pressure in the next few quarters. Yet behind the revenue growth, there is a pricing and biosimilar risk that investors should be aware of if... Read the full narrative on Regeneron Pharmaceuticals (it's free!) Regeneron Pharmaceuticals' narrative projects $19.4 billion revenue and $6.0 billion earnings by 2029. Uncover how Regeneron Pharmaceuticals' forecasts yield a $833.31 fair value, a 20% upside to its current price. Some of the lowest analysts were already assuming only about 6 percent annual revenue growth to roughly US$17.8 billion and modest margin compression, so if you worry about pricing pressure and rising R&D, you may find their more cautious take on Regeneron a useful counterpoint to the latest quarter’s US$4,290.7 million in sales. Explore 7 other fair value estimates on Regeneron Pharmaceuticals - why the stock might be worth over 3x more than the current price! Disagree with existing narratives? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Regeneron Pharmaceuticals research is our analysis highlighting 3 key rewards that could impact your investment decision. Our free Regeneron Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Regeneron Pharmaceuticals' overall financial health at a glance. Markets shift fast. These stocks won't stay hidden for long. Get the list while it matters: We've uncovered the 9 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. Find 49 companies with promising cash flow potential yet trading below their fair value. Explore 26 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include REGN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

MELBOURNE, Australia and INDIANAPOLIS, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces its financial results for the year ended December 31, 2025. FY 2025 key results1 Group performance2: Double-digit revenue growth and positive adjusted operating cash flow Revenue of US$803.8 million, up by 56%3 and achieving upsized full year guidance4. US$157.1 million invested in research and development (R&D) product development for late-stage therapeutics and precision medicine pipeline assets5, in line with stated FY 2025 guidance. Adjusted EBITDA6 of US$39.5 million, reflective of increased operating expenditure driven by strategic acquisitions, investment in commercial infrastructure and research and development (R&D). A non-material loss before tax of US$5.3 million, includes US$26.7 million in non-cash finance costs associated with convertible bonds and increased asset amortization of US$11.9 million (2024: US$5.1 million) following the RLS Radiopharmacies (RLS) acquisition. Year-end cash balance of US$141.9 million following US$246.4 million of strategic investments (M&A) and cash generated from operating activities of US$34.5 million before the final contingent consideration payment to Advanced Nuclear Medicine Ingredients (ANMI) of US$51.8 million7. Telix Precision Medicine: Strengthening commercial profitability, driving growth Precision Medicine segment revenue up by 22% year-over-year, driven by continued increase in Illuccix® volumes and successful launch of Gozellix® in the U.S. Gross margin remains stable at 64%. Adjusted (segment) EBITDA up by 24% year-over-year to US$216.4 million. Selling and marketing expenses of US$82.4 million, reflecting incremental investment in global commercial infrastructure for new product launches (Illuccix EU, Gozellix, Zircaix®8 and Pixclara®8). TLX101-Px (Pixclara8) regulatory filings: Telix has filed a marketing authorization application for TLX101-Px in Europe, concurrent to finalizing the New Drug Application (NDA) package for the U.S. Food and Drug Administration (FDA). TLX250-Px (Zircaix8) submission: Based on the two Type A meetings with the FDA, Telix believes it has aligned on key outstanding issues for the Biologics License Application (BLA) resubmission, including demonstration of drug product comparability between clinical trial material and scale-up commercial production. The Company is now completing the agreed deliverables and documentation required for resubmission. Telix Manufacturing Solutions (TMS): Expanded global operations to deliver patient outcomes TMS segment includes RLS, IsoTherapeutics (TX, U.S.), and production (and R&D) facilities in Sacramento (CA, U.S.), Brussels (Belgium), North Melbourne (Australia) and Yokohama (Japan), representing a significantly expanded global production and manufacturing footprint. RLS reported US$238.4 million of total segment revenue, which includes US$170.1 million from third-party product sales and service fees, and US$68.3 million inter-segment revenue9, reflecting excellent growth in sales of Illuccix and Gozellix through the RLS network. RLS transitioned to positive adjusted EBITDA contribution of US$1.2 million. RLS operating loss includes US$7.4 million of depreciation and amortization on acquired intangibles. Adjusted EBITDA loss for the TMS segment of US$21.7 million, expenditure consistent with first half, demonstrating inter-company cost control (H1 2025: Adjusted EBITDA loss of US$12.7 million). Telix Therapeutics: Prioritization of R&D investment towards advancing late-stage assets Of the total R&D investment, US$98.0 million was invested in the therapeutics pipeline. Milestones achieved include: TLX591-Tx (lutetium (177Lu) rosopatamab tetraxetan): Completed target enrollment of 30 patients for Part 1 of the ProstACT® Global10 Phase 3 study in metastatic castration resistant prostate cancer (mCRPC). First patients treated in Part 2 (randomized expansion)11. TLX250-Tx (177Lu-DOTA-girentuximab): Received regulatory approval to commence LUTEON12, a global Phase 2/3 monotherapy trial in metastatic clear cell renal cell carcinoma (ccRCC), initiating sites. First patients dosed in the STARLITE-113 Phase 1b/2 investigator-initiated trial exploring TLX250-Tx in combination with cabozantinib and nivolumab in ccRCC. TLX101-Tx (iodofalan 131I): Received regulatory approval in Australia and the European Union to commence the IPAX-BrIGHT14 pivotal trial of TLX101-Tx in recurrent glioblastoma (GBM). TLX592-Tx (225Ac-PSMA-RADmAb): Received regulatory approval to commence AlphaPRO15, a Phase 1, first-in-human (FIH) study of Telix's targeted alpha therapy (TAT) candidate in advanced mCRPC. TLX252-Tx (225Ac-DOTA-girentuximab): Received regulatory approval to commence ALPHIX16, a Phase 1, FIH study of Telix's TAT candidate for the treatment of patients with advanced metastatic kidney cancer and other carbonic anhydrase IX (CAIX) expressing cancers. TLX300-Px (89Zr-olaratumab): First patients dosed in the ZOLAR17 Phase 1, FIH imaging study for patients with advanced, metastatic soft tissue sarcoma (STS) and other platelet derived growth factor receptor alpha (PDGFRα) positive tumors, aiming to demonstrate proof of concept for therapy. TLX090-Tx (153Sm-DOTMP): First U.S. patients dosed in SOLACE18, a Phase 1 study evaluating safety, dosimetry, patient‑reported outcomes, and potential opioid‑sparing effects of TLX090‑Tx in patients with metastatic bone pain. FY 2026 Guidance Telix provides FY 2026 Group Revenue guidance of US$950 million to US$970 million. Guidance reflects revenue from product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS. Telix provides pipeline R&D expenditure guidance of US$200 million to US$240 million. Executive Commentary Managing Director and Group CEO, Dr. Christian Behrenbruch, commented on the result: “Our strong commercial performance in 2025 provides a platform for continued growth across Telix’s global Precision Medicine franchise. The revenue guidance we are issuing today reflects our confidence in sustaining the momentum of our core cash generative business. Consistent with our stated strategy, we are reinvesting earnings to prioritize the acceleration of our best-in-class therapeutic pipeline, which now includes three pivotal stage trials in prostate, kidney and brain cancer. We also intend to continue to expand the Precision Medicine growth opportunity through label expansion studies and new product launches. In 2026 we are focused on delivery of these near‑term priorities to further strengthen the foundations for long‑term revenue and earnings growth.” Summary: Group financial results Investor call An investor webcast and conference call will be held at 9:30 a.m. AEDT on Friday 20 February 2026 (5:30 p.m. EST Thursday 19 February 2026). Participants can register for the webcast or the teleconference by clicking here: https://edge.media-server.com/mmc/p/famdpwzh To read or download the 2025 Annual Report and to view the accompanying investor presentation, visit Telix's Investor Relations website: ir.telixpharma.com/ 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, United Kingdom, Canada, Europe (Belgium and Switzerland), Brazil 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). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA. Telix’s osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix’s miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. 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 U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Guidance Disclaimer The stated revenue 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 listed below. 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. This announcement has been authorized for release by the Telix Pharmaceuticals Limited Board of Directors 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 Annual Report 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, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including the planned NDA resubmission for TLX101-Px and the planned BLA resubmission for TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization 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 commercial 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 impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; 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. Non-IFRS Financial Measures. Telix’s results are reported under International Financial Reporting Standards (IFRS). This announcement includes various non-IFRS financial information to reflect its underlying performance, which have not been subject to audit or review. These non-IFRS measures include Adjusted EBITDA, which represents net earnings attributable to the Group excluding net finance costs, income tax expense, depreciation and amortization and other gains/(losses) (net). As required by SEC rules, we have provided reconciliations of these non-IFRS financial measures to the most directly comparable IFRS measures, which for Adjusted EBITDA, is Profit/(loss) before income tax. The Group believes that these non-IFRS measures, which are not considered to be a substitute for or superior to IFRS measures, provide stakeholders with additional useful information on the underlying trends, performance and position of the Group and are consistent with how business performance is measured internally. The non-IFRS measures are not defined by IFRS and therefore may not be directly comparable with other companies’ alternative performance measures. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 1 See summary Group financial results table at end of this document. 2 Group performance includes Telix Precision Medicine, Telix Therapeutics and Telix Manufacturing Solutions (TMS). 3 All comparisons to FY 2024 results. 4 Revised FY 2025 revenue guidance of US$800 million to US$820 million. 5 US$14.1 million of inventory for TLX250-Px (Zircaix®) commercial launch is additionally expensed to R&D. This expense arises from commercial inventory produced in anticipation of Zircaix approval and will be reversed upon FDA approval if received. 6 Earnings before interest, tax, depreciation and amortization. 7 In 2018, Telix acquired ANMI, the developer of the underlying Illuccix technology. The acquisition agreement included contingent consideration (variable payments) based on Illuccix global sales for five years following marketing authorization of Illuccix, with an option to buy out remaining payments in the third year following marketing authorization if agreed sales thresholds were met. As a result of strong sales performance, Telix successfully exercised its option to buy-out the remaining variable payments. The final payment of US$51.8 million comprising the option payment and third and final annual variable payment was made in July 2025, and is reflected in the cash flows for H2 2025, included in the Company’s full year financial results. 8 Launch and brand names subject to final regulatory approval. 9 Inter-segment revenue is eliminated on consolidation, refer to note 3 of the financial statements lodged today with the ASX. 10 Telix ASX disclosure August 21, 2025. ClinicalTrials.gov ID: NCT06520345. 11 Telix media release December 8, 2025. 12 ClinicalTrials.gov ID: NCT07197580. 13 ClinicalTrials.gov ID: NCT05663710. 14 ClinicalTrials.gov ID: NCT07100730. 15 Telix ASX disclosure August 21, 2025. 16 Telix ASX disclosure January 20, 2026. 17 Telix media release April 2, 2025. ClinicalTrials.gov ID: NCT06537596. 18 Telix media release October 23, 2025. ClinicalTrials.gov ID: NCT07197645. 19 Earnings before interest, tax, depreciation and amortization and other gains/(losses) (net).

Management describes the Precision Medicine segment as a strategic engine that validates therapeutic targets and builds physician relationships rather than just a cash generator. The company has pivoted toward an internal innovation model for R&D to capture higher value, citing the high market premiums paid for early-stage radiopharmaceutical assets. Vertical integration through over $0.5 billion in infrastructure investment is viewed as a critical moat due to the complex logistics and short shelf life of radiopharmaceuticals. Revenue growth of 56% to $804 million was driven by strong Illuccix demand and the successful launch of Gozellix, which utilizes the acquired ARTMS production technology. Management attributed the delay in Pixclara and Zircaix approvals to a tumultuous period within the FDA and has since boosted regulatory affairs capabilities and management teams. The commercial strategy focuses on selling complex clinical workflows rather than simple products, creating a barrier to entry for smaller competitors who lack specialized sales forces. Full year 2026 revenue guidance of $950 million to $970 million assumes 20-25% growth from currently approved products and excludes potential upside from pending approvals. R&D investment is projected to rise to $200 million to $240 million, with the majority allocated to transitioning toward a high-value therapeutics business. Management expects 2028 to be the pivotal commercial launch year for the therapeutics business, supported by clinical data readouts expected throughout 2026 and 2027. The company intends to prioritize reinvesting revenues into the pipeline and infrastructure over the next 2 to 3 years rather than optimizing for near-term earnings per share. The BiPASS Phase III study is expected to complete enrollment in 2026, targeting a move into frontline diagnosis to expand the total addressable market by 2027. The RLS acquisition delivered positive EBITDA in its first 11 months, though its lower-margin generic business diluted overall group gross margins to 53%. A final contingent consideration payment of $52 million for Illuccix impacted net operating cash flow, which otherwise would have been $35 million positive. Management noted that R&D spending is discretionary and can be flexed or 'ring-fenced' based on commercial performance to maintain a prudent cash buffer. The company is increasingly moving manufacturing in-house to prevent 'educating the ecosystem' and losing intellectual property to contract manufacturing organizations. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Data will be released simultaneously with the FDA submission once clinical case report forms are formally closed out and quality controlled. The independent data safety review board has already cleared the study to progress to randomization ex-U.S. based on prespecified safety criteria. Maintaining two products (Illuccix and Gozellix) allows Telix to navigate different reimbursement frameworks, specifically managing price-sensitive versus reimbursement-preferred accounts. This strategy provides flexibility as CMS reimbursement models evolve toward Average Sales Price (ASP) benchmarks. The FDA requires remediation of laboratory and process documentation rather than new clinical trials. A key deliverable involves proving comparability between research-grade material used in Phase III and the commercial scale-up material. Management explicitly stated that a profit objective is 'not the name of the game' for 2026 or 2027. The company expects to invest the vast majority of earnings back into R&D and commercial expansion to unlock long-term pipeline value. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Telix reported full-year revenue of $804 million (up 56%) with adjusted EBITDA of $39.5 million and $206 million cash from operations, and guided 2026 revenue to $950–$970 million (roughly 20%+ growth). Management frames Telix as a vertically integrated radiopharmaceutical platform and has invested over $500 million in manufacturing and supply chain, saying it will reinvest the bulk of earnings into R&D, commercial expansion and infrastructure in 2026–27. Key pipeline priorities include resubmissions for Pixclara and Zircaix (targeting potential 2026 approvals), a possible ProstACT interim futility readout in Q4, and continued global rollout of Illuccix with ongoing regulatory filings in China, Japan and Europe. Interested in Telix Pharmaceuticals Limited? Here are five stocks we like better. Telix Pharmaceuticals (NASDAQ:TLX) outlined a year of sharp top-line growth, continued investment in infrastructure, and an increasingly diversified product and pipeline strategy as management discussed full-year results and 2026 priorities on its earnings call. Chief Executive Officer and Managing Director Christian Behrenbruch described Telix as a radiopharmaceutical “platform” spanning five major segments: a therapeutics pipeline; internal innovation and discovery capabilities; the commercial precision medicine business; a specialty sales organization; and vertically integrated manufacturing and supply chain. → Corning’s Surprise AI Boom: Is It Already Too Late to Buy? Behrenbruch emphasized that reliable manufacturing and distribution can be a differentiator in radiopharmaceuticals due to short product shelf lives, noting Telix has invested “over $500 million” in recent years to strengthen infrastructure and control delivery. He also said the precision medicine business is more than a cash generator, calling it strategic validation of therapeutic targets, a way to streamline clinical trials, and an avenue to deepen relationships with physician stakeholders. Looking ahead to 2026, Behrenbruch said the company’s priorities are centered on: Continuing to grow approved products, including building on the launch of Gozetotide and the FDA approval of Gleolan in 2025. Launching two additional products pending regulatory outcomes: Pixclara (Pixlumia in Europe) for glioblastoma and Zircaix for renal cancer. Advancing several late-stage clinical programs, including pivotal and Phase III studies, with key near-term catalysts. → 3 Discount Retail Stocks to Watch as Earnings Put Valuations to the Test Behrenbruch acknowledged investor disappointment that Pixclara and Zircaix were not approved last year, but said the company has made “extensive changes” to management, boosted regulatory capabilities, and believes both programs are in good shape for resubmission and potential approval in 2026. Chief Financial Officer Darren Smith reported full-year revenue of $804 million, representing 56% growth and “in line with our uplifted full year guidance.” Smith highlighted it as Telix’s third consecutive year of double-digit revenue growth. → PayPal Is Back Near IPO-Era Prices—Value Setup or Value Trap? Within the precision medicine business, revenue increased 22% year-over-year, and Smith said EBITDA for that segment improved 25% to $216 million, driven by demand for Illuccix and the launch of Gleolan. On the consolidated income statement, Smith said: Group gross margin was 53%, consistent with first-half performance. Product development investment totaled $157 million, focused mainly on the late-stage pipeline. General and administration expenses decreased to 12% of revenue from 17% in the prior year, which management attributed to scale efficiencies. Adjusted EBITDA was $39.5 million, which Smith said was in line with market consensus. Smith also discussed cash flow and liquidity. Telix generated $206 million from operations in 2025 and ended the year with $142 million in cash. Excluding a $52 million contingent consideration earn-out payment tied to Illuccix, Smith said the company produced $35 million of net positive operating cash flow. Management guided to full-year 2026 revenue of $950 million to $970 million, which Smith described as implying roughly 20%+ revenue growth. He said the guidance is based on “current approved products in approved jurisdictions” and does not include any incremental contributions from pending product approvals. For R&D, Telix expects to invest $200 million to $240 million in 2026, with the largest allocation directed toward therapeutics development. Smith said the R&D range will depend on achieving certain clinical outcomes and development milestones. During Q&A, Behrenbruch addressed questions about profitability expectations, stating that Telix is not providing guidance beyond 2026 but that it is a “reasonable expectation” the company will invest the majority of earnings back into the business in 2026 and 2027. He added that a near-term profit objective is “not the name of the game,” with reinvestment spanning R&D, commercial expansion, and infrastructure. Behrenbruch also said R&D investment is discretionary and can be adjusted, with the company prioritizing a set of highlighted trials—four therapeutic studies and the BYPASS study—if changes are needed. Precision Medicine CEO Kevin Richardson said the precision medicine portfolio delivered $622 million in revenue in 2025, up 22% year-over-year, with sequential growth in every quarter. Richardson noted that Q3 was the “most challenging quarter” because it was the first full quarter after Illuccix’s transitional pass-through status expired and Medicare reimbursement transitioned to mean unit cost (MUC) for a subset of patients. Even so, he said the business delivered 3% quarter-over-quarter dose growth and 1% sales growth in Q3. Richardson attributed performance to “clinical differentiation and operational reliability,” adding that Telix’s PSMA agents show fewer indeterminate bone lesions and higher inter-reader agreement compared with F-18 assets, which he said supports confidence in clinical decision-making. He also highlighted Gleolan’s launch trajectory. Gleolan received FDA approval in April 2025, and transitional pass-through status became effective in October, enabling what he described as a pass-through-supported full launch in Q4 2025. Richardson said the company is “very pleased with the early uptake.” Richardson said Telix is the only company with two PSMA agents on the market and described the dual-product strategy as a competitive advantage that provides customers with economic choice and scheduling flexibility. In response to an analyst question, he added that having two products helps Telix manage different customer reimbursement dynamics—including HOPPS accounts versus independent diagnostic testing facilities—and offers flexibility as CMS reimbursement evolves. Richardson said Illuccix is available with reimbursement in 17 countries and has marketing authorizations in more than 24 markets. He said 2025 efforts focused on country-by-country access, while 2026 will pivot toward uptake in key European markets including the U.K., France, Germany, Italy, and Spain. On Asia, Richardson said Telix and partner Grand Pharma submitted an NDA in China after a Phase III study that produced a 94.8% positive predictive value, including patients with very low PSA levels. In Japan, he said a 105-patient Phase III study is progressing, with the first patient dosed. For Zircaix, Richardson said Telix has completed two Type A meetings with the FDA and believes it has alignment on key resubmission requirements. During Q&A, management said Zircaix remediation items are largely related to manufacturing and documentation, including a comparability deliverable between research-grade and commercial-scale material, and that Telix does not yet have definitive timing from the FDA on review duration after resubmission. For Pixclara, Richardson said TLX101-CDx was recently filed with European regulators and a U.S. submission will follow. He also noted Pixclara has orphan drug and fast track designations from the FDA, and said commercial, medical, and supply chain teams are “launch-ready,” citing expanded access programs and anticipated commercial use. Behrenbruch said Telix expects to soon release part one safety and dosimetry data from the ProstACT Global study at the same time it submits information to the FDA to request adding U.S. patients into the randomized portion of the study. In response to an analyst question, he said the company is not waiting on the FDA, but rather completing case report forms and validating the data set for submission and disclosure. He also provided an updated expectation for a part two interim futility analysis in ProstACT Global, indicating it could occur in Q4 based on current recruitment trajectory, while noting timelines can change in clinical trials. Telix Pharmaceuticals (NASDAQ: TLX) is a clinical-stage biopharmaceutical company focused on the development and commercialization of molecularly targeted radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging expertise in radiochemistry, nuclear medicine and oncology, Telix aims to address unmet clinical needs across a range of tumor types by pairing diagnostic imaging agents with therapeutic radionuclides. The company’s pipeline spans both imaging and therapeutic candidates. The article "Telix Pharmaceuticals H2 Earnings Call Highlights" was originally published by MarketBeat.

This article first appeared on GuruFocus. Revenue: $804 million, a 56% growth year-over-year. Precision Medicine Revenue: $622 million, up 22% year-over-year. EBITDA: Improved by 25% to $216 million. Gross Margin: 53%, consistent with the first half performance. Cash Balance: $142 million at year-end. R&D Investment: $157 million, focused on late-stage pipeline. General and Administration Expenses: Decreased to 12% of revenue from 17% last year. Adjusted Earnings: $39.5 million, in line with market consensus. 2026 Revenue Guidance: $950 to $970 million, implying up to 25% growth in precision medicine business. 2026 R&D Investment Guidance: $200 to $240 million. Warning! GuruFocus has detected 6 Warning Sign with TLPPF. Is TLPPF fairly valued? Test your thesis with our free DCF calculator. Release Date: February 19, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Telix Pharmaceuticals Ltd (TLPPF) reported a 56% growth in revenue to $804 million, marking the third consecutive year of double-digit revenue growth. The precision medicine business saw a 22% year-over-year increase in revenue, with EBITDA improving by 25% to $216 million. The company successfully launched Gozelix, which has been FDA approved and is expected to drive future revenue growth. Telix Pharmaceuticals Ltd (TLPPF) has a robust pipeline with over 30 sponsored and collaborative studies, including pivotal trials that are expected to generate significant commercial and financial inflection points. The company maintains a solid cash balance of $142 million, allowing it to self-fund R&D investments and commercial infrastructure without shareholder dilution. The European market for Telix Pharmaceuticals Ltd (TLPPF)'s products is experiencing delays due to the complex reimbursement landscape, which can take 9 to 12 months post-approval. Gross margins for the RLS business segment are lower due to the commoditized nature of third-party nuclear medicine products. The company faces ongoing competitive pressure in the precision medicine market, which could impact future growth. There are uncertainties regarding the timeline for FDA review and approval of new products, which could affect the launch schedule. Telix Pharmaceuticals Ltd (TLPPF) plans to reinvest earnings into R&D and commercial expansion, potentially impacting short-term profitability. Q: When can we expect to see safety data for the 59 study, and what are the next steps with the FDA? A: We have had an independent data safety review board that has reviewed the data and progressed to randomization. We need to complete the clinical case report forms and validate the data before submitting it to the FDA. Once available, we will simultaneously disclose it and submit it to the FDA. We are not waiting on anything from the FDA; it's all on the company side, and you will not have long to wait. - Christian Behrenbruch, CEO Q: Can you elaborate on the two-product strategy for Aus6 and Goelic and how it will drive 25% growth in precision medicine revenue? A: The two-product strategy allows us to manage economic needs and preferences for reimbursed versus non-reimbursed products. It helps us navigate the changing reimbursement environment and manage ASP as CMS evolves. This strategy provides options without locking down a singular product. - Kevin Richardson, CEO of Precision Medicine Q: How does the European market for Aluix and Gazellics compare to the US, and what are the challenges? A: The European market has a different reimbursement landscape, with delays between product approval and reimbursement. There are no material sales until reimbursement is secured, which can take 9 to 12 months. We have only just received reimbursement in some EU countries, and we are executing market launches now. - Christian Behrenbruch, CEO and Kevin Richardson, CEO of Precision Medicine Q: What are the key drivers for gross margin improvement, especially for the RLS business? A: The RLS segment reports third-party products, which have lower margins. Our products through RLS are captured in the precision medicine segment, which maintains mid-60% margins. As more of our product volume goes through our in-house pharmacy network, the gross margin has the potential to improve towards 70%. - Christian Behrenbruch, CEO Q: What is the timeline for the part two interim analysis of the Prospect Global study? A: The part two study is recruiting well, and the interim analysis is based on about 80 to 90 events. We expect the futility analysis to read out in Q4 of this year, based on the current recruitment trajectory. - Christian Behrenbruch, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.