Sandoz Group Ag S/Adr

Good morning, ladies and gentlemen, and welcome to the Sandoz call today. I will now pass on to Craig Marks, head of investor relations, for his opening remarks.

Thank you. Welcome to the Sandoz Q1 sales update. Earlier today, we published a press release and an accompanying presentation on our website, which will follow on today's call. You can find these documents at sandoz.com strokeinvestors. Joining me on today's call are Richard Saylor, Chief Executive Officer, and Remco Steenbergen, Chief Financial Officer. Please turn to slide two. Our sales announcement, presentation, and discussion include forward-looking statements. Please see our disclaimer here. Please turn to slide three. Richard will begin today's presentation with a summary of the highlights in the quarter, followed by an update on the business. Remco will cover the sales performance as well as full year guidance. Following the wrap-up of the presentation, we'll be happy to take your questions. With that, I will now hand over to Richard. Please turn to slide four.

Thank you, Craig, and hello, everybody. It's a pleasure to welcome you all to today's call, and I'm looking forward to talking you through our continued progress. Please turn to slide five. There are four key messages I'd like you to take away from this morning. Firstly, the quarter one sales performance was in line with our expectations, meaning we've now delivered 14 consecutive courses of top-line growth. This reconfirms our growing track record of execution and performance. Secondly, we again delivered double-digit growth in biosimilars in the quarter, ahead of more launches later this year, putting us in an excellent position to produce good results in 2025. The new confirmed U.S. tariffs have been absorbed within our four-year guidance. And lastly, we're confident in our plan for this year and beyond, and we're extremely well positioned to deliver on our reiterated four-year guidance. Now, let's move to the details of the business performance, starting with slide six. Before we go into the performance of our biosimilars, I wanted to take you through the initial steps of what could be a very significant beneficial movement towards regulatory streamlining, potentially ending the requirement to conduct phase three by a similar trial. In light of the involving global regulatory landscape and growing indications that major regulatory authorities will move to a streamlined by a similar clinical program, we're already minimizing our ongoing Pembrolizumab phase three trial. We believe that this trial will no longer be considered scientifically necessary to confirm that it produces the same clinical outcome as its reference medicine. There is unlikely to be a blanket-wide decision by the regulators on streamlining. It may be a more case-by-case basis, but we're encouraged by these first developments that could lead to significant changes for the industry and for patients. Turning to our approved biosimilars, I'll provide more color on Omnitrope Hymeros, Tyruco, and Pestiva in the following slides. But let me just say a word on YOS-Gibonti and Envizu. Last year, we launched YOS-Gibonti, or biosimilar to Nosemab, in Canada, and we're looking forward to the launch in the U.S. in the coming weeks. We plan to launch YOS-Gibonti and Aflipicept as biosimilar in Europe later this year. The U.S. launch timing of Envisu remains dependent on several factors, including the progress and outcome of potential litigation or potential settlements. Please turn to slide seven. Now, let me deep dive on some of our other biosimilars. After almost 20 years after it was launched, we're again delivering double-digit growth for Omnitrope, which continues to speak to the sustainability of biosimilars. The performance, again, undermined our continued market leadership, driven by a particularly strong result in the international region, which is expected to continue. Please turn to slide eight. Turning to Heimerod's, again, we delivered good growth in Europe. In the U.S., the launch is continuing to go very well. In addition to our private label arrangement with Cordavis, we're on formulary with the major pharmacy benefit managers with our own branded Hymeros and unbranded Adelunumab. This puts us in a leading position in terms of market access and payer coverage amongst Adelunumab via Simulus. In the quarter, we saw significant price erosion in the private label setting, a dynamic you'd expect to see at this stage. Sandoz remains a market leader amongst biosimilars, and we anticipate seeing changes in formularies to benefit biosimilar penetration during 2025. In summary, we're extremely well positioned to capture market share in what is a growing market. Please turn to slide nine. We started rolling Tyruco out across Europe around 18 months ago. Since then, this important medicine has been growing consistently, reaching 21% market share as per the most recent IQVIA data. Both tender authorities and healthcare professionals appreciate a more affordable option in the multiple sclerosis space. In the U.S., we are continuing to work with our partner and the FDA on the potential approval of our JCV assay and remain confident of launching Tyreco before the end of this year. Finally, Ustikinema continues to make strong progress in the quarter following the European launch of Pisceva in 2024. We are amongst the first companies to launch with all key reference strengths by the end of the year, and the medicine has been launched in 22 markets. Uptake continues to be very strong, and we've achieved a leading position in Europe. Position reception is very positive, reinforced by the availability of an initiation dose, which is key to enabling patient switches. Ustekinumab by similar penetration has now reached 30%, a higher level than that of Adalidumab penetration at this stage of a launch. We're also delighted to launch PeaceGiva in February in the U.S. You may have seen that the originator's request for a preliminary injunction on the launch of private label Ustekinumab was denied this week, and we look forward to the launch in due course. With that, I will hand over to Remco.