Release Date: August 22, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Telix Pharmaceuticals Ltd (ASX:TLX, Financial) reported a 65% increase in revenue for the first half of 2024, driven primarily by strong sales of Illuccix in the US market.
- The company successfully raised $650 million in convertible bonds, significantly strengthening its balance sheet and enabling further strategic investments.
- Telix Pharmaceuticals Ltd (ASX:TLX) completed two strategic acquisitions, enhancing its manufacturing capabilities and supporting its vertical integration strategy.
- The company is making significant progress in its prostate cancer therapy program, with positive data from the ProstACT SELECT study and the expansion of the ProstACT GLOBAL Phase III trial into the US.
- Telix Pharmaceuticals Ltd (ASX:TLX) is advancing its pipeline with multiple late-stage therapeutic programs in prostate, kidney, and brain cancer, and expects further key data in the second half of the year.
Negative Points
- Despite the strong revenue growth, the company faces challenges in the US reimbursement landscape, which is described as quite challenging.
- There was a minor setback with the FDA submission for Zircaix, requiring an updated BLA to address manufacturing issues.
- The company is still in the process of integrating its recent acquisitions, which could pose operational challenges.
- Telix Pharmaceuticals Ltd (ASX:TLX) has significant ongoing investment requirements for its pipeline and manufacturing capabilities, which could impact short-term profitability.
- The company has not yet provided specific guidance on the commercial strategy for its 591 asset, leaving some uncertainty about its market approach.
Q & A Highlights
Q: Could you talk a little bit about whether the market penetration of Illuccix in the US is uniform or if there are variations?
A: The market dynamic in the US is shifting towards larger scale acquisitions through IDN and group purchasing organizations. While there is a concentration of PSMA imaging in major metropolitan areas and academic centers, there are still opportunities for penetration in community settings. The ability to deliver PSMA imaging locally is a significant advantage for patients.
Q: Regarding 591, do the infrastructure and relationships built for Illuccix give you optionality around marketing 591 yourselves or seeking a partner?
A: We have built a very capable commercial team and are delivering on a large-scale indication. We have a strong nexus with the customer base using Illuccix, which is also used for Pluvicto therapies. While we haven't committed one way or another, we are not lacking in capabilities to commercialize our products.
Q: Could you talk about the opportunity you see in Brazil and whether it applies to diagnostics like Illuccix?
A: Brazil is a substantial market with a lot of prostate cancer cases. We aim to service patients globally and see potential for significant revenue from jurisdictions like Brazil. The R2 Pharma relationship in Brazil is promising, and once we get ANVISA approval, it could open up the whole continent for us.
Q: Could you comment on trial enrollment for ProstACT GLOBAL and expectations for interim data?
A: We expect to put out interim results next year. Site activation is going well, with a good number of US and APAC sites ramping up. We are working on adding European and other countries towards the back half of this year and early next year. There is high scientific interest in the differentiated asset approach of the trial.
Q: Can you discuss your expectations for the launch of Zircaix and Pixclara diagnostics?
A: We are optimistic about these assets. The urology space is well-informed about the benefits of molecular imaging. We expect rapid adoption of the kidney cancer product Zircaix, and Pixclara has a high degree of concentration in specific customers. Both products have significant market potential and are expected to perform well upon approval.
Q: What are the expectations for interim data from ProstACT GLOBAL next year?
A: We haven't given specific guidance yet. We have a run-in phase for CMC comparability, and once finalized, we will present results to the FDA and provide more detailed guidance on the randomization phase.
Q: Can you provide insights on the efficacy expectations for TLX250 in the STARLITE-2 study?
A: The goal is to understand how targeted radiation layers with immune checkpoint inhibitors and to assess overlapping toxicities. We are encouraged by the study's progress and plan to provide an update in the next few months. We are also considering a monotherapy study in end-stage renal cancer to develop a therapeutic signal.
Q: What lessons can be learned from Actinium's regulatory feedback for your targeted conditioning asset?
A: We focus on yttrium-90 for our program due to its clinical workflow advantages and better manufacturability. We believe our approach will have better clinical outcomes and be easier to handle compared to iodine-131.
Q: Can you explain the EAP for Zircaix in the US and plans for European approval?
A: The EAP in the US is company-supported, providing access to key renal cancer centers. We have had positive scientific consultations in Europe and plan to submit for centralized approval early next year. We expect a good price point for Zircaix in Europe.
Q: Do you have any views on the 64 Cu SAR-bisPSMA product in development versus Illuccix?
A: The product is still in clinical development and faces significant supply chain and clinical deployment issues. We believe the real-world use of copper-64 will be limited compared to the established success of F-18 and gallium-68 in prostate cancer imaging.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
