Telix Pharmaceuticals Conference Call Summary Company Overview - **Company**: Telix Pharmaceuticals (NasdaqGS:TLX) - **Industry**: Radiopharmaceuticals, focusing on oncology - **2025 Performance**: Achieved over $800 million in sales, primarily from the U.S. prostate cancer imaging franchise with two FDA-approved products [3][4] - **2026 Revenue Guidance**: Projected revenue between AUD 950 million and AUD 970 million, reflecting approximately 25% growth in the precision medicine business unit [5][6] Core Business Insights - **Focus Areas**: Urologic oncology and neuro-oncology [3] - **Growth Drivers**: - Continued growth in the PSMA (Prostate-Specific Membrane Antigen) imaging market, estimated at 5%-7% annually due to market education and increased urologist engagement [7] - Launch of a second prostate cancer product, Gozellix, which received pass-through status [8] - Ongoing Phase 3 BYPASS trial aimed at expanding the total addressable market (TAM) for prostate cancer imaging [9][10] Clinical Trials and Product Pipeline - **BYPASS Trial**: A significant Phase 3 trial that aims to improve biopsy accuracy using gallium PSMA PET scans, potentially reducing the need for invasive procedures [30][33] - **ProstACT Global Trial**: A Phase 3 trial for mCRPC (metastatic castration-resistant prostate cancer) that includes a randomized study design with various treatment cohorts [39][40] - **IPAX-BRIGHT Trial**: A Phase 3 trial for TLX101 in brain cancer, focusing on overall survival as the primary endpoint [68][71] - **TLX250 for Renal Cell Carcinoma**: Ongoing studies exploring combination therapies in a rapidly evolving treatment landscape [76][77] Market Opportunities and Challenges - **Prostate Cancer Imaging**: The BYPASS trial could lead to significant market expansion, with over 1 million biopsies performed annually in the U.S., many of which yield inconclusive results [30][31] - **Patient Compliance**: The potential to improve patient compliance and engagement through less invasive imaging techniques [38] - **Competitive Landscape**: The need to differentiate from other modalities, such as T-cell engagers, by emphasizing the short duration of treatment and integration into standard care [63][66] Future Directions - **Alpha Emitters**: Exploration of TLX592, an alpha emitter, with a focus on its potential advantages over beta emitters in targeting specific cancer types [54][58] - **Innovative Targets**: Plans to introduce novel targeting agents and expand the pipeline with a mix of validated and novel targets [92] - **Long-term Vision**: Aiming to establish a strong position in the radiopharmaceutical market by leveraging unique pharmacological approaches and addressing unmet medical needs [87][88] Conclusion - Telix Pharmaceuticals is positioned for significant growth in the oncology space, particularly in prostate cancer imaging and treatment, with a robust pipeline and strategic focus on innovative therapies. The company is actively addressing market challenges and exploring new opportunities to enhance patient outcomes and expand its market presence [3][4][5][6][7][8][9][10][30][31][39][40][68][71][76][77][87][88][92]

Telix Pharmaceuticals FY Conference Summary Company Overview - **Company**: Telix Pharmaceuticals (NasdaqGS:TLX) - **Focus**: Development of therapeutics pipeline, particularly in the radiopharmaceutical space - **Key Leadership**: Group CEO Christian Behrenbruch Core Industry Insights - **Industry**: Radiopharmaceuticals - **Market Dynamics**: Increased investment in in-house innovation and development of therapeutics pipeline - **Competition**: Notable competitors include Novartis, Lantheus, and others in the radiopharmaceutical market Financial Performance - **2025 Revenue**: Record year with AUD 804 million, a 56% year-on-year increase - **2026 Guidance**: Expected revenue in the range of $950-$970 million, excluding unapproved products [5][6] Product Pipeline and Strategy - **Therapeutics Pipeline**: Three programs in late-stage clinical trials, with a focus on growing core business and launching new products - **Key Products**: - **Zircaix and Pixclara**: Expected to be refiled in 2026, significant revenue streams anticipated [6][32] - **Gozellix**: Launched with a new clinical utility and different distribution profile, expected to drive average selling price (ASP) higher [15][16] - **RLS Acquisition**: Successful acquisition contributing to revenue and expected to grow with third-party contracts [6][25] Market Expansion and International Strategy - **International Expansion**: Filed Pixclara in Europe and NDA in China, with ongoing studies in Japan [28][29] - **Market Opportunities**: Potential to double the size of the prostate cancer imaging market in the U.S. through ongoing studies [29][30] Clinical Trials and Data - **ProstACT Global Trial**: U.S. requirement met, progressing to randomization ex-U.S. with a focus on safety and dosimetry [39][41] - **TLX250 and TLX090**: Expected updates and interim analyses in 2026, with potential for early approval based on positive data [75][82] Key Challenges and Considerations - **Regulatory Hurdles**: Previous CRLs for Pixclara and Zircaix have delayed timelines but are now being addressed [32][34] - **Market Perception**: Company viewed as a pro rata of Lantheus, with a need to better communicate the value of its therapy pipeline [84][85] Conclusion - **Outlook**: Positive growth anticipated in 2026 with a strong focus on therapeutics and international expansion, despite regulatory challenges and market competition [6][84]

Summary of Telix Pharmaceuticals FY Conference Call Company Overview - **Company Name**: Telix Pharmaceuticals (NasdaqGS:TLX) - **Industry**: Targeted Radiopharmaceuticals - **Revenue**: Expected to be just under $1 billion for the year, primarily from precision medicine, specifically imaging [3][6] - **Global Presence**: Commercially active in 26 countries with a diverse R&D pipeline focused on therapeutic oncology [3][4] - **R&D Investment**: Approximately $300 million allocated for R&D and infrastructure development [3] Key Products Precision Medicine - **Illuccix**: - Flagship product launched in 2021, a PSMA-targeting agent. - Competes with Lantheus, which had a first-mover advantage. - Transitioned off transitional pass-through reimbursement in Q2 last year [9][10]. - **Gozellix**: - Lifecycle management product for Illuccix, with reimbursement secured. - Offers clinical advantages, including a longer shelf life and improved transport capabilities [10][11]. - Aims to service high-volume accounts and penetrate underserved areas [11][12]. Therapeutics - **TLX591**: - Antibody linked to lutetium-177, currently in a pivotal study for prostate cancer. - The study has transitioned to the randomized phase, with data expected soon [28][30]. - **Zircaix**: - Focused on renal cell carcinoma, with a BLA filed and expected to launch this year. - The company is harmonizing EU and US submissions to streamline the approval process [23][25][27]. Market Dynamics - **Prostate Imaging Market**: - Estimated growth of 5%-7% annually, driven by increasing awareness and clinical value of PSMA imaging [16]. - BiPASS trial aims to potentially double the market size by adding 800,000 scans [18][19]. - **PET Scanner Capacity**: - Increasing demand for PET scans due to growth in various disease areas. - New installations and advancements in scanner technology are expected to alleviate capacity issues [20][21]. Regulatory Challenges - **FDA Interactions**: - Experienced setbacks with two CRLs for glio and renal products, but ongoing collaboration with the FDA is noted as positive [24][26]. - Learning curve in submitting PET biologics, with expectations for approval still high [27]. Competitive Landscape - **Market Positioning**: - Aims to differentiate from competitors like Pluvicto by focusing on survival benefits and unique dosing regimens [47][49]. - Emphasizes the importance of OS (Overall Survival) as a key metric for success in the market [50][51]. Future Outlook - **Pipeline Development**: - Plans to expand therapeutic offerings with a focus on combination therapies, particularly in renal cancer [61]. - Anticipates significant data releases and product launches in 2026, with a strong emphasis on diagnostics and therapeutics [62]. Conclusion - Telix Pharmaceuticals is positioned as a significant player in the targeted radiopharmaceutical space, with a robust pipeline and strategic focus on both diagnostics and therapeutics. The company is navigating regulatory challenges while aiming for market differentiation through innovative product offerings and a strong emphasis on clinical outcomes.

Company Overview - Telix Pharmaceuticals focuses on radiopharmaceuticals for cancer diagnosis and treatment, emphasizing the importance of early detection in cancer care [1] - The company is developing cancer-targeting molecules that can be attached to radioactive isotopes for both detection and treatment of cancer [3] Market Growth - Cancer diagnostics is projected to grow at a compound annual rate of 8.33% from 2026 to 2035, reaching a market size of $378.4 billion [2] - Telix's revenue for 2025 was reported at $804 million, reflecting a 56% increase, with management forecasting 2026 revenue between $950 million and $970 million, a 19% increase at the midpoint [7] Product Development - Telix's lead products, Illuccix and Gozellix, are designed to identify prostate-specific antigen-positive cells using PET scans, with increasing regulatory approvals and recent U.S. launch of Gozellix [8] - The company has a robust R&D pipeline, including four late-stage and six early-stage candidates targeting various cancers, such as kidney cancer and glioblastoma [9] Clinical Trials - Telix is advancing two key drugs in phase 3 trials: TLX591 for prostate cancer and TLX250 for kidney cancer, both capable of using isotopes for detection and treatment [11] Competitive Advantage - The acquisition of RLS Pharmacies for $250 million has provided Telix with a distribution network, enhancing its competitive position in the radiopharmaceutical market [13] - This integrated ecosystem allows Telix to manage the distribution of its products more effectively compared to competitors reliant on external partners [13] Investment Potential - Analysts have a bullish outlook on Telix, with an average 12-month price target of $21.30, indicating significant upside potential from its current price of under $7 [14]

Core Insights - The Precision Medicine segment is viewed as a strategic engine that validates therapeutic targets and builds physician relationships rather than merely serving as a cash generator [1] - The company has shifted towards an internal innovation model for R&D to capture higher value, highlighting the high market premiums for early-stage radiopharmaceutical assets [1] - Vertical integration through over $0.5 billion in infrastructure investment is considered a critical competitive advantage due to the complex logistics and short shelf life of radiopharmaceuticals [1] Revenue Growth - Revenue increased by 56% to $804 million, driven by strong demand for Illuccix and the successful launch of Gozellix, which utilizes the acquired ARTMS production technology [1] Regulatory Affairs - Delays in approvals for Pixclara and Zircaix were attributed to a tumultuous period within the FDA, prompting the company to enhance its regulatory affairs capabilities and management teams [1] Commercial Strategy - The commercial strategy emphasizes selling complex clinical workflows rather than simple products, creating barriers to entry for smaller competitors lacking specialized sales forces [1]

Core Insights - Telix Pharmaceuticals is launching two additional products, Pixclara for glioblastoma and Zircaix for renal cancer, pending regulatory outcomes [1] - The company reported a full-year revenue of $804 million, reflecting a 56% increase, and is guiding for 2026 revenue of $950 million to $970 million, indicating over 20% growth [6][11] - Telix emphasizes its vertically integrated radiopharmaceutical platform, having invested over $500 million in manufacturing and supply chain improvements [2][6] Financial Performance - Full-year revenue reached $804 million, up 56%, marking the third consecutive year of double-digit growth [8] - Adjusted EBITDA was $39.5 million, with a gross margin of 53% [9] - The precision medicine segment saw a 22% year-over-year revenue increase, totaling $622 million [15] Product Pipeline and Strategy - Key pipeline priorities include resubmissions for Pixclara and Zircaix, with potential approvals targeted for 2026 [5][7] - The company is focusing on a dual-product strategy with its PSMA agents, which provides competitive advantages in customer choice and reimbursement dynamics [17] - Telix plans to invest $200 million to $240 million in R&D for 2026, primarily directed towards therapeutics development [12] Global Expansion and Regulatory Efforts - Illuccix is available in 17 countries, with ongoing efforts for market access in key European markets [18] - The company has submitted an NDA in China and is progressing with a Phase III study in Japan [19] - Regulatory submissions for Pixclara and Zircaix are in progress, with the company confident in meeting FDA requirements for resubmission [20][21]

Financial Data and Key Metrics Changes - The company reported a 56% growth in revenue to $804 million, marking its third consecutive year of double-digit revenue growth [17][19] - EBITDA improved by 25% to $216 million, driven by strong demand for Illuccix and the launch of Gleolan [19][23] - The gross margin remained stable at 53%, with a significant portion of gross margin generated from the precision medicine business [22][23] Business Line Data and Key Metrics Changes - Revenue from the precision medicine business increased by 22% year-over-year, contributing an additional $113 million [19][23] - The precision medicine business generated approximately $400 million in gross margin, with 94% of the gross margin coming from this segment [20][23] - Investments in product development totaled $157 million, focusing on late-stage pipeline projects [22] Market Data and Key Metrics Changes - The precision medicine portfolio delivered $622 million in revenue, with sequential growth every quarter, even during challenging market conditions [30] - The company is expanding its market presence, with Illuccix now available in 17 countries and marketing authorizations in over 24 markets [35] Company Strategy and Development Direction - The company aims to transition to a high-value therapeutic business, with planned R&D investments ranging from $200 million to $240 million in 2026 [26] - A dual product strategy for Illuccix and Gleolan is in place to manage economic needs and reimbursement preferences effectively [58][60] - The company is focused on expanding its product offerings, indications, and geographical reach, particularly in key markets like the U.K., Germany, and China [35][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving approximately 20% revenue growth in 2026, with guidance set at $950 million to $970 million [28][29] - The company is committed to reinvesting earnings into R&D and commercial growth rather than optimizing near-term earnings per share [68] - Management highlighted the importance of clinical credibility and operational reliability in sustaining market leadership [32][33] Other Important Information - The company has over 30 sponsored and collaborative studies running, with four major trials expected to generate significant data this year [47] - The ProstACT Global study is progressing well, with recruitment for part two ramping up [48][49] Q&A Session Questions and Answers Question: When might we see data for 591, the safety data? - The company is completing clinical case report forms and will disclose the data simultaneously with the FDA submission, with no delays expected from the FDA side [54][56] Question: Can you elaborate on the early performance of the two-product strategy for Illuccix and Gleolan? - The two-product strategy allows the company to manage economic needs and reimbursement preferences effectively, adapting to changes in the reimbursement environment [58][60] Question: Will the company reinvest earnings to achieve close to zero NPAT for F-26, F-27, and F-28? - The company will reinvest the majority of earnings back into R&D and commercial growth, with no profit objective for the next two years [68] Question: How much growth in precision medicine revenue is coming from markets outside of the U.S.? - Currently, 95% of revenue is U.S.-based, but the company expects this mix to change as it expands into other markets like Japan [74]

Financial Data and Key Metrics Changes - The company reported a 56% growth in revenue to AUD 804 million, marking its third consecutive year of double-digit revenue growth [18][20] - EBITDA improved by 25% to AUD 216 million, driven by strong demand for Illuccix and the launch of Gozellix [20][23] - The gross margin remained stable at 53%, with 94% of gross margin generated from the precision medicine business [21][22] Business Line Data and Key Metrics Changes - Revenue from the precision medicine business increased by 22% year-over-year, contributing an additional AUD 113 million [20][23] - The precision medicine business demonstrated a 28% increase in operating profit and a 25% increase in EBITDA [23] - The company invested AUD 157 million into product development, focusing on its late-stage pipeline [22] Market Data and Key Metrics Changes - The precision medicine portfolio generated AUD 622 million in revenue, up 22% year-over-year, with sequential growth every quarter [31] - Illuccix is now available in 17 countries with reimbursement secured, and marketing authorizations in over 24 markets [35] - The company anticipates a 25% growth in its precision medicine business for 2026, driven by the full year of RLS revenue [28] Company Strategy and Development Direction - The company aims to transition to a high-value therapeutic business, with planned R&D investment in the range of AUD 200 million to AUD 240 million for 2026 [26] - The focus will remain on reinvesting revenues back into the business rather than optimizing near-term earnings per share [26][72] - The company is committed to building long-term value through disciplined capital allocation and strategic investments in R&D and commercial performance [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving another year of roughly 20%+ revenue growth in 2026, with guidance set at AUD 950 million to AUD 970 million [28][30] - The company is focused on executing its strategic plan to grow the precision medicine business by expanding product offerings and geographic reach [35] - Management acknowledged the challenges faced with regulatory approvals but emphasized the importance of learning from these experiences to enhance future submissions [15][72] Other Important Information - The company has over 30 sponsored and collaborative studies running, with four major trials highlighted as priorities for the year [49] - The ProstACT Global study is currently recruiting for part two, with results expected to be released soon [50] - The company has made extensive changes to its management team and regulatory affairs capabilities to improve future product submissions [15] Q&A Session Summary Question: When might data for 591 be available? - Management indicated that the company is not waiting on the FDA and will disclose data as soon as it is available [56][58] Question: Insights on the two-product strategy for Illuccix and Gozellix? - The two-product strategy allows the company to manage economic needs and preferences of different customer types, adapting to changes in reimbursement environments [61][62] Question: Clarification on reinvesting earnings for future years? - Management confirmed that the majority of earnings will be reinvested back into the company for growth, particularly in R&D and commercial development [72] Question: Growth contribution from markets outside the US? - Currently, 95% of revenue is US-based, but the company expects this mix to change as it expands into other markets [78] Question: Will R&D spending be adjusted based on commercial performance? - Management stated that R&D investment is discretionary and can be adjusted based on commercial performance, focusing on priority studies [75][76]

Financial Data and Key Metrics Changes - The company reported a 56% growth in revenue to AUD 804 million, marking its third consecutive year of double-digit revenue growth [15][17] - EBITDA improved by 25% to AUD 216 million, driven by strong demand for Illuccix and the launch of Gozellix [17][20] - The gross margin remained stable at 53%, with 94% of gross margin generated from the precision medicine business [19][20] Business Line Data and Key Metrics Changes - Revenue from the precision medicine business increased by 22% year-over-year, contributing an additional AUD 113 million [17][20] - The precision medicine business demonstrated a 28% increase in operating profit and a 25% increase in EBITDA [20] - The company invested AUD 157 million into product development, focusing on its late-stage pipeline [19] Market Data and Key Metrics Changes - The precision medicine portfolio delivered AUD 622 million in revenue, up 22% year-over-year, with sequential growth every quarter [28] - Illuccix is now available in 17 countries with reimbursement secured, and marketing authorizations exist in over 24 markets [32] - The company anticipates a 25% growth in precision medicine revenue in 2026, driven by the full year of RLS revenue [26] Company Strategy and Development Direction - The company aims to transition to a high-value therapeutic business, with planned R&D investment in the range of AUD 200 million to AUD 240 million for 2026 [24] - A dual product strategy for Illuccix and Gozellix is expected to enhance market share and manage economic needs of healthcare accounts [56] - The focus remains on reinvesting revenues back into the business rather than optimizing near-term earnings per share [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving another year of double-digit revenue growth, with guidance set at AUD 950 million to AUD 970 million for 2026 [26][27] - The company is committed to disciplined financial management and anticipates strong momentum heading into 2026 [25][27] - Management highlighted the importance of clinical credibility and operational reliability in sustaining market leadership [30] Other Important Information - The company has over 30 sponsored and collaborative studies running, with four major trials identified as priorities for the year [46] - The ProstACT Global study is progressing well, with recruitment for part two ramping up [47] - The company is focused on expanding its product offerings and indications, particularly in key markets like China and Japan [32][33] Q&A Session Summary Question: When might data for 591 be available? - Management indicated that the company is not waiting on the FDA and will disclose data as soon as it is available [52][54] Question: Insights on the two-product strategy for Illuccix and Gozellix? - The two-product strategy allows the company to manage economic needs and adapt to changing reimbursement environments [56][59] Question: Will earnings be reinvested to achieve close to zero NPAT for F-26, F-27, and F-28? - Management confirmed that the majority of earnings will be reinvested back into the company for growth initiatives [66][67] Question: How much growth in precision medicine is coming from markets outside the US? - Currently, 95% of revenue is US-based, but the company expects this mix to change as it expands into other markets [72] Question: Thoughts on the collaboration with Atley and Stanford focusing on astatine-211? - Management expressed excitement about the potential of astatine-211 and its fit within the product portfolio [76]

Full Year Results Presentation For personal use only February 20, 2026 ASX: TLX | NASDAQ: TLX - FY 2025 treatment 18 F -FET scan published in EJNMMI showing a patient with recurrent glioblastoma (GBM) who experienced a near -complete response following treatment with TLX101 -Tx (Iodofalan (¹³¹I), [¹³¹I]IPA), Telix's investigational LAT1 -targeted therapy. Patient representative scans, individual results may vary. Post - treatment Pre Presenters Agenda For personal use only Kyahn Williamson SVP Investor Rela ...