CSL Limited

Thank you for standing by and welcome to the CSL Limited half-year financial results. All participants are in a listen-only mode. There will be a presentation followed by a question and answer session. If you wish to ask a question, you will need to press the star key followed by the number one on your telephone keypad. I would now like to hand the conference over to Mr. Chris Cooper, Head of Investor Relations. Please go ahead.

Good morning and welcome to CSL's first half results call for fiscal 2025. It's Chris Cooper speaking and I'm pleased to be joined here today by Dr Paul McKenzie, CSL's chief executive officer, and John Levy, CSL's interim chief financial officer. As with past practice, Paul will provide an overview of the results and then John will provide additional detail on the financials. We'll then move to Q&A. Please note, this briefing is being webcast. And lastly, before we start, I draw your attention to the forward statement disclaimer contained in the slide deck. I'll now hand over to CSL's CEO, Dr. Paul McKenzie.

Thank you, Chris, and good morning, everyone. Thank you for joining us for CSL's first half results call for fiscal year 25. Before I get into the results, a word on my management team. I am pleased to say that Andy Schmeltz will resume the role of Executive Vice President for CSL Bearing in March, and Joy Linton, who has been filling in for Andy, will resume the role of Chief Financial Officer. I would like to thank both Joy and John for their significant contributions during this interim period. Now on to the results. CSL has delivered a solid result for the first half of fiscal year 25, driven by the strong performance of CSL Bearing Business and also growth in CSL v4. Importantly today, we are reaffirming our guidance for fiscal year 25 for NPAD A, which is expected to grow by 10 to 13%. CSL Securus' performance was impacted by weak market conditions in the U.S., and I will go into more detail on this shortly. First, the headline numbers. Revenue was $8.5 billion, up 5% at constant currency. NPAD A was $2.1 billion, also up 5%. And net profit after tax was $2 billion, up 7%. In terms of the major highlights for the period, the CSL Bearing business delivered strong growth of 10%, driven once again by the IG franchise, which grew 15%, and another robust performance by Albumen. The gross margin for CSL Bearing continues to improve and was up 170 basis points at constant currency. The rollout of the Ricca plasmapheresis machines is well advanced, and we are excited to implement the iKnomi technology in December. This is already delivering benefits as planned. The uptake of hemogenics continues to accelerate, with the four-year data reinforcing the strength of this product. And the regulatory process for Garidacimab, our next generation HAE therapy, which has been branded Endembri, is progressing well. Approvals have been received in Australia and the UK. A positive CHMP recommendation was received in Europe. And our resubmitted filing in the US was accepted by the FDA. Moving over to CSL Securus, as I said at the beginning, its performance has been negatively impacted by the significant decline in immunization rates in the U.S., specifically in the 18 to 64-year cohort, which drove competitive pressures in the market. While this is a disappointing outcome for public health, there are signs that vaccination rates outside the U.S. are stabilizing, which gives us some comfort on the future market outlook. During the period, CSL Securus secured several pandemic tenders for avian flu. The majority of this revenue will be recognized in the second half of the year. CoStave was launched by our partner in Japan. This is the world's first self-amplifying mRNA vaccine for the prevention of COVID-19 in adults. Switching over to CSLV4, revenue was up 6%, driven by both iron and nephrology. Ferrinject delivered volume growth of 6% in Europe. In nephrology, Tavanos performed strongly, and we successfully launched Filspare in Europe. Focusing now on CSL Bearing, where revenue was up 10% at constant currency. As I mentioned, growth in our IG franchise was strong. Underlying demand continues to be robust in all of our core indications, and patient diagnosis rates continue to improve. Sales were up 15% with strong growth recorded across all geographies. Our intravenous IG products were up 15%, and our subcutaneous product, Hycentra, was up 16%. For Hycentra, the uptake of our recently launched 50 ml pre-filled syringe in both the U.S. and the EU has accelerated. Hycentra continues to be the clear market leader in subcutaneous treatment for patients in PID and CIDP. Our albumin portfolio grew strongly by 9%, driven by exceptional performance in China. Hemophilia growth was 11%, with Adelvion up 6%. Contributing to the growth in hemophilia is our gene therapy, Hemgenix. I am pleased to say that the uptake is accelerating as we slowly but steadily find a way through the complexities of the U.S. healthcare system to bring this transformative therapy to patients. Further, last week we announced the four-year results from the Pivotal Hope B study. These results underscore the ability of hemogenics to offer long-term bleed protection with a single treatment. Plasma-derived hemophilia products grew by 6%. Led by UMATE and HayMATE are treatment for patients with von Willebrand disease. Specialty products were down 5%, where the loss of a substantial contract for Kcentra saw its sales decline by 20% in the period. Despite the loss of this contract, Kcentra remains the clear market leader in a growing market. In HAE, Haegarda was up 1% and Bernert up 6%. We've been able to add new patients and preserve our existing patient base ahead of bringing Endembri to market in the second half of this financial year. Moving to the operating highlights for CSL Bearing on slide six. The underlying fundamentals of plasma collection remain strong. Plasma donations continue to grow, and we have seen further reduction in our cost of collecting plasma as we continue to focus on introducing innovation and driving efficiencies in our plasma centers. This is helping to drive improvement in the gross margin for CSL bearing. One of our biggest focus areas has been the rollout of the RECA platform. As I mentioned earlier, we are well advanced with this major change program with 220 centers now operating with Ricoh machines. We are on track to have this completed on all U.S. centers by June this year. The other exciting component of the Ricoh platform is the introduction of the iKnomi technology, which we implemented in December last year as planned. we are observing an increase in donor yields of around 10% on average. As a reminder, all RECA machines to be rolled out over the next half will utilize the iNOMI technology immediately. Our Horizon 1 and Horizon 2 yield initiatives are both progressing with Horizon 1 continuing to deliver tangible yield benefits as it is incorporated into our existing manufacturing processes across the network. The other highlights for CSL Bearing that we are excited about is the progress we have made on bringing our homegrown monoclonal antibody, Garidacimab, to market for patients suffering with HAE. Branded as Indembri, we have recently received regulatory approvals in Australia and the UK, a positive CHMP recommendation in the EU, and our resubmitted BLA was accepted by the FDA in December. Our phase three study evaluating RehaStat for the treatment of acquired fibrinogen deficiency is progressing in Europe and we are preparing for a filing in the US. These are important early steps in our patient blood management strategy. Moving on to the next slide and results for CSL Securus. Revenue for CSL secures was down 9%, and this was significantly impacted by the decline in vaccination rates for influenza in the US, particularly in the 18 to 64 cohort. After increasing sharply during the COVID pandemic, vaccination rates have declined for various reasons, with consumer apathy and reduced access being two of the main factors. Lower vaccination rates have also led to competitive pressures in the market. This weak market backdrop has led to a disappointing result for CSL Seqirus this period. However, the incidence of influenza and hospitalization rates are up, and this poses a significant public health risk. In Europe, there are signs that vaccination rates are stabilizing, and over time we expect to see a similar recovery in the U.S. For the full year, the negative performance of the seasonal influenza vaccines will be offset to some extent by CSL Secure's leadership position in pre-pandemic preparedness as we secured several tenders for avian flu. As I mentioned, the majority of this revenue will be recognized in the second half. Finally, the first half also included revenue from the supply of COSTAVE to our partner in Japan. Turning to the next slide and operational highlights for CSL Securus. FluCellVAX received a positive CHMP opinion for six month plus age extension in the EU. It also launched in Switzerland and listed on Australia's national immunization program. Fluad. STITCO, Germany's highly influential technical advisory group, has given Fluad a preferential recommendation for the over 60s population. This recommendation underscores the effectiveness and public health value of Fluad. We expect this to be a benefit for SALS in the upcoming Northern Hemisphere season. Fluad was also awarded central tender for key populations in Finland and Denmark, and also launched in Taiwan and South Korea. On the pandemic side of the business, we were selected by BARDA, HERA, and the UK government to deliver H5 vaccines for preparedness against potential avian flu outbreak in humans. And under product innovation for ATIVC, the initial data supports our projected profile, and we expect to have the full 12-month data set in the third quarter of this calendar year. As I mentioned, we supplied doses of CoStave to our partner in Japan, and we presented one-year data from a head-to-head study demonstrating that our self-amplifying COVID-19 vaccine provided a durable and superior response compared to the conventional mRNA vaccine. Turning to CSLV4 on slide 9, revenue was up 6%. For iron, revenue was up 3%. We continue to maintain our leadership position in Europe, with volume growth in Farinject up 6 percent. In the U.S., injector for sales were up 3 percent, with step edit policies remaining stable. The launches of Farinject in China and Canada are on track. For nephrology, Macera cells normalized in this half after a strong comparable period in which a new agreement came into effect with a large dialysis provider. After completion of this very successful rollout, Macera is a well-established standard of care in the U.S. Valforo's performance was driven by strong demand. Tavernos saw solid sales growth in Europe with increased patient penetration. Filspare was successfully launched in Germany, Austria, and Switzerland. Focusing now on the operating highlights for CSLV4. On the commercial side, CSLV4 continues to execute on its strategy to remain the market leader in iron. Our flagship iron product, Firinject, is navigating the competitive landscape in the EU with volumes growing strongly. Iron deficiency remains a significant challenge around the world, and CSLV4 is well-positioned to continue its leadership role in helping patients. For nephrology, we have seen strong growth across the portfolio, driven by the successful launches of Tavanos and Filspare in Europe and Valforo in China. We remain on track for over 30 country launches in fiscal year 25 and see significant long-term growth opportunities in nephrology. The R&D pipeline is progressing with a key highlight being the Phase III study for clazikizumab for end-stage kidney disease, which is actively enrolling in 32 countries. I will now hand over to John, who will take you through the financials in more detail.