Thomas Lingelbach
Analyst · Jefferies
Thank you, Josh. Good day, everyone. Yes, our first quarter was certainly dominated by the Lyme Phase III readout. With the strong efficacy observed, the first prespecified statistical criteria not met, but the second one met, Pfizer is planning for submissions to regulatory authorities. On financials, we reported a top line of approximately EUR 30 million. A year-on-year, quarter-to-quarter comparison is, however, with regards to this first quarter, not really meaningful because of various factors, including a different business setup, supply phasings, one-off effects on the expense side, all of that will be elaborated by Peter during his respective financial report. Given the level of uncertainty around Lyme, our strong focus is on cash containment and management. We reported a strong cash position, which excludes the proceeds from the recent financing, more than EUR 100 million total cash at the end of the first quarter and launched a comprehensive program to reduce our operating expenses, which also includes a reduction of global workforce by approximately 10% to 15% and aims to result in a significant 25% to 35% reduction in our operating expenses as compared to last year. With that, let me turn to our programs and to our key business activities. I reported already about the statistical miss and the fact that the second prespecified statistical criteria met the lower bound. Overall, the efficacy, as you can see on the slide, is above 70%, which is really strong. The vaccine was well tolerated. There were no safety concerns identified at the time of analysis. The reason for all of that is that we have observed fewer-than-anticipated Lyme disease cases that were accrued over the study period. Given, however, the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was above 20 in the second prespecified analysis, Pfizer is confident in the vaccine's potential and hence, as mentioned earlier, is planning submissions to regulatory authorities. Lyme represents a major medical need and hence market opportunity. There is no vaccine currently available to prevent Lyme disease in humans. And we see a continuous rise of the annual burden of disease. We have here in this slide, reported the numbers of people who live in high-risk areas of Lyme disease, almost 90 million in North America, more than 200 million in Europe and an annual disease burden of a reported 500,000 cases in the U.S., more than 100,000 in Europe. Also, we all acknowledge that those reported numbers are probably heavily underreported. Clinically, Lyme comes with different clinical manifestations. 10% to 30% of the individuals develop either carditis, neuroporosis or arthritis. And some, namely 5% to 10% of the cases continue to have persistent symptoms even following treatment. As such, we see VLA15 or LB6V using the Pfizer terminology as a compelling opportunity in a highly underserved market. It is the only Lyme disease vaccine candidate in such a stage of development in nearly 30 years. It's highly differentiated. We built on a proven mode of action, but with a broad coverage addressing all the prevalent serotypes prevalent on both sides of the Atlantic. It is a modern state-of-the-art recombinant protein-based subunit vaccine. We tested individuals in the study aged 5 years and above. And as I mentioned, we continue seeing a growing disease burden across high-risk areas, and some of you have recently seen, again, articles in this regards. There is, of course, a strong strategic fit with Pfizer's existing business and franchise. And overall, we really see a prophylactic solution as the solution of choice for this disease. As such, we remain confident. We remain confident in the prospect of this vaccine to ultimately make its way to patients or to people who are in need of it. Turning over to Chikungunya. Our IXCHIQ product is continuing its path through different R&D activities besides limited commercial sales in travel. The overall market evolution, market development and access in emerging markets and low medium-income countries is, however, quite remarkable and is progressing quite nicely. We have a very significant pilot vaccination campaign ongoing in Brazil. The vaccine is being given to adults 18 to 59 years of age. And the objective is to reach a 20% to 40% coverage within this target population across various municipalities in Brazil. We have already vaccinated more than 30,000 people to date, and we are aiming for much more than 100,000 overall. There is also additional work ongoing to prepare for post-marketing effectiveness in Brazil and in other jurisdictions. Currently, we are focusing on creating a strong safety database with our study 406, which is well advanced and is nearing completion of the enrollment. We are working on ensuring greater access to this vaccine in endemic countries. We have a project ongoing to expand the network of manufacturing and distribution partners in those countries, and we are making good progress. We reported very recently through our different social media channels that the locally produced Chikungunya vaccine by Butantan called Butantan-chik achieved licensure in Brazil. This has been a major, major achievement in the endeavor that is supported by CEPI and for which we are grateful on advancing this vaccine and advancing access into countries and for countries who can really benefit from it. A few words on Shigella and our shigellosis program. It is certainly one of the most advanced, if not the most advanced tetravalent vaccine candidate against shigellosis. We are targeting the 4 most common pathogenic Shigella bacteria. And previously, our partner, LimmaTech reported positive initial Phase I/II data. We have currently 2 studies ongoing, one in children in Africa and the other one is an immunogenicity and pilot efficacy study, so-called controlled human infection model. For both, we are expecting the first readouts or the readouts over the summer. And then as we discussed and reported previously, we will decide on next development steps for this program and for this program addressing a global market that is expected north of 0.5 billion annually. Given the severity of shigellosis, especially that it's the fact that it is the second leading cause of fatal diarrhea in children. And it, therefore, has been prioritized by WHO and other funding institutions. So overall, a lot going on, on our key R&D and business activities. And with that, I would like to hand over to Peter to provide us with the financial report.