Roche Holding AG

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In addition to that, you may also raise your virtual hand to address your questions verbally. For participants joining via phone, to raise your hand, use star nine on your phone's dial pad. When you then get selected to ask your questions, please follow the instructions from the phone and dial star nine and then star six to unmute yourself. One last remark, if you would like to follow the presented slides on your end as well, please feel free to go to roche.com slash investors to download the presentation. At this time, it's my pleasure to introduce you to Thomas Schieneker, CEO Roche Group. Mr. Schieneker, the stage is yours.

Good morning and good afternoon, everyone. Together with my team, I'm looking forward to presenting the Q1 2023 results. So let's get right into it. Group sales declined by 3% and this was driven by the expected decline in COVID-19 testing. The underlying base business in both divisions reported strong growth results, which meant for the group plus 8% for the base business. Pharma had a very strong performance in Q1 with plus 9%, and this was driven by the ongoing portfolio rejuvenation. We had also a good diagnostics base business growth of plus 4%. The COVID-19 sales decline is in line with our full year 2023 expectations and our full year guidance of roughly minus 5 billion Swiss francs. The growth in pharma was strongly supported by the key products and new medicines, Vabaismo, Ocrevus, Hemlibra, Evristi, Ticentric, Progetta, Fesco and Polyvi. And we've had a number of key approvals already in the first quarter. Let me highlight PolyV in first-line diffuse large B-cell lymphoma in the US, Hemlibra in moderate haemophilia A in the EU, and Columv or glufitinib in third-line DLBCL in Canada. And we are now rolling it out also into other countries. In diagnostics, we launched several new oncology tests and navigated digital solutions. Let me also give you an update on the pipeline in the first quarter. We had a positive phase three study, IAMBRAVE050, of Dicentric and Avastin in adjuvant hepatocellular carcinoma, where we hit on the RFS primary endpoints. and overall survival is still immature. We've had also a positive phase three study in Krovalumab with Krovalumab in PNH. For the remainder of the year, we expect at least another 14 late stage readouts. And among those are a number of line extensions and pivotal readouts for another two NMEs. and we also have a strong pipeline of upcoming launches in diagnostics. On this slide, you see the Q1 sales development for the group and for the divisions. Group sales reached 15.3 billion Swiss francs, down 3% in constant exchange rates, and excluding the impact of COVID-19 sales, you see we grew by 8%, which is a fantastic growth. COVID-19 sales erosion in Q1 was only in the diagnostics division, which you can clearly see on this slide. Diagnostics declined by 28%, and excluding COVID testing sales, diagnostics grew by plus 4%, and Matt will give you more details here. Pharma grew strongly with 9%, driven by ongoing portfolio rejuvenation. And you see that COVID-19 didn't have any material impact on the sales growth rates. This slide summarizes the key and most important movements in Q1. The diagnostics-based business grew with 146 million. And here you also see a strong decline in diagnostics COVID-19 sales by minus 1.6 billion. So we had roughly 300 million testing sales in Q1. The pharma underlying business continues to do extremely well based on the new medicines. growing by 1.3 billion. And I would say the buy small really stood out again with sales of 432 million. So really being now the biggest growth driver in our portfolio. AHNR is completely in line with our expectations. And on the right hand side, you see how our portfolio diversification is ongoing. In the light orange, you can see AHNR back in 2018 made about 40% of our total sales and oncology was about 50% of our total sales. Now, moving forward in 2023, while growing, you see that AHNR is now a significantly smaller part of our business, and also we have diversified into other disease areas, such as neuroscience, playing a much bigger part, Haemophilia A, but also ophthalmology, where you see that Vabaismo is taking a bigger share of the cake, and this will continue to go into this direction. This slide shows the underlying performance by quarter. Pharma growing 9% and having no impact from Ronaprev. Diagnostics-based business growing with 4%. Again, Matt will take you through those numbers in more detail. Since 2015, we've launched 19 new medicines, and these new medicines are expected to deliver growth in the next years. We've had the latest launch of Columv or Clovitamab, a bispecific CD20, CD3 antibody. The first launch was in Canada, but we are in the process of rolling this out throughout the world. The Biduva date is set for July 1st. We have the possibility for two further NMEs this year, Crovalimab in PNH, where we already had a positive phase III readout, and SRP9001, which is a gene therapy for Duchenne muscular dystrophy. Now, there is the expectation that the Phase III will read out at the end of the year, but depending on an FDA approval, we have the opportunity to launch in a number of countries ahead of this Phase III readout. On the right-hand side, you can see that the new launches now account for more than 50% of the pharma sales, which is eight percentage points more than in Q1 2022. And you can also see the increasing contribution from Vabaisement, which has achieved blockbuster status after only four quarters and is one of the best launches in the history of Roche. And it is already approaching annualized sales of about two billion, if you extrapolate the March sales numbers. Now, let me provide you with a quick update on our pipeline, and I'm sure Theresa will take you through those in more detail. I've already mentioned the positive phase 3 T-centric and Avastin study in adjuvant HTC. The data was presented at AACR. We've had a negative trial outcome for T-centric and chemo in adjuvant triple negative breast cancer. I've already mentioned the positive phase three data for Crovalimab in PNH, and we have already shared the positive news on SOSFIMO in DME and DR in the full year 2022 presentation. Now, let me also share quickly an update to my team. Since April, we now have the team complete, and I'm very proud of this team because I believe we have a very strong team that will take this organisation forward. We have two new CEOs for both divisions. Theresa Graham as the Pharma CEO, Matt South as the Diagnostic CEO. In addition, we have two new people with two roles that were not present on the CEC in the past, now part of the CEC. First, Levi Gerway, our Head of Pharma Development and our Chief Medical Officer. who is now part of the Corporate Executive Committee. Now, with this move, the entire pharma research and development now have a seat at the Corporate Executive Committee, including people like Hans Klevers and Avriv Rejev, who are leading the early research and development organizations and who were already part of the CEC in the past. Together with James Sabri, our head of partnering, they will work closely together to make sure that we have a clear focus on our pipeline going forward silke hernstein has also joined the corporate executive committee it's again a new role as head of strategy and sustainability and she will help lead our future esg activities and also our strategic initiatives This slide should be very familiar to you as we presented it at the full year 2022 presentation. Let me reiterate, the guidance remains unchanged and we see that the sales drivers continue to perform as we had expected in the beginning of the year. In pharma, we have our key products, new medicines, new launches with strong growth and momentum. as you've already seen in Q1. In diagnostics, we expect good base business growth. We do also expect a significant decline in COVID-19 sales of roughly 5 billion Swiss francs across the two divisions, with a decline of 1.6 billion already in the first quarter. And this is in line with our expectations. H&R sales are expected to erode by roughly 1.6 billion. In the first quarter, we had an erosion of 330 million. This is also in line with our expectations. We confirm the full year 2023 guidance. Group sales to decline in the low single digit range. Core EPS is broadly in line with the sales decline and dividend to further increase in Swiss francs. And with that, I hand over to our new CEO for Pharma, Theresa Graham.