Thierry Bernard
Analyst · Citi. Please go ahead
Thank you, Roland, and I'd like to invite you for a quick update now on the progress QIAGEN teams have made regarding our five pillars of growth. In this slide, for example, you can see a brief overview of our portfolio expansion goals for 2021 and our status after the first quarter. We are continuing to focus on our road map and on providing robust menus to support strong growth in all areas beyond COVID testing. In sample technologies, for example, in which QIAGEN has a large portfolio of market-leading sample extraction solutions, we continue to leverage our experience and innovate to bring new solutions to the market. As an example, in the first quarter, we launched QIAcube Connect for molecular diagnostic and the new QIAprep& kit. I will give you more details on these new products in the next slide. As we continue to successfully roll out QIAcuity digital PCR platform, our teams are working to expand the field of research applications for those systems. For example, a new workflow for integrating digital PCR and exosome-based liquid biopsy for the detection of bladder cancer from urine samples is being released into clinical trials. And QIAstat diagnostic syndromic testing system now features a new connectivity solution that we call QIAsphere. This is a cloud-based platform allowing users to monitor tests and instruments remotely. We continue to be focused on menu expansion and capacity scale up to support the use of installed platform beyond COVID testing needs. For NeuMoDx, our integrated PCR testing platform for core labs, we are also on track for two FDA submissions plans for this year. In the first quarter of 2021, as you can see, our U.S. menu has grown with the receipt of the Emergency Use Authorization for a four plex test with simultaneous detection of flu A and B, RSV and SARS-CoV-2. In our QuantiFERON franchise, we are moving forward with planned launches with the recent release of the LymeDetect assay on DiaSorin LIAISON platform. This assay was developed as part of our ongoing partnership with DiaSorin to leverage our proven QuantiFERON technology on their large installed base of testing platforms. I will share once again more details on this opportunity in the next slide. Let's go back to the sample technologies. As you know, our sample technologies product group has continued to perform well throughout the pandemic. And since Q4 2020, we are seeing significant demand returning from sample preparation kits used in applications outside of COVID. Sales in our non-COVID kits grew over 22% in Q1 2021 versus Q1 2020 demonstrating once again the strength of our sample technologies business and proving that we are not depending here from the – on the pandemic. On this slide, I would like to highlight a few launches in this product group. As noted before, the QIAcube Connect instrument for automated sample processing has now been launched globally for diagnostic applications. This system is the latest addition to the QIAcube family of instruments and builds on the successful launch of the QIAcube Connect in research application. The new placements in clinical labs will add to over 9,800 systems installed from the QIAcube family worldwide. We are also expanding our proprietary QIAprep& portfolio with the newly launched artus SARS-CoV-2 prep& kit, which has been CE marked and is now submitted for Emergency Use Authorization in the U.S. The QIAprep&Amp technology, if you remember, was initially launched in October last year in a kit for viral epidemiology, and we have seen significant demand for this product to automate rapid processing of RNA viral samples on standard labs equipment. The new kit launched in April combines liquid-based sample prep with PCR assay technology to enable clinical labs to rapidly scale up COVID testing. I would also like to highlight an upcoming launch for the new generation of QIAGEN EZ1 sample processing in three months, which is extremely well-known worldwide for its ease of use. The EZ2 connect instruments will feature connectivity, much like the QIAcube and QIAstat instruments, using the cloud-based QIAsphere solution popular for remote monitoring. In the third quarter, platforms will be launched for research and pharmaceutical application as well as in forensic labs for human identification application, and clinical platform is planned for launch early 2022. And for this, I would like to remind you what we explained in our QIAGEN Deep Dive Day in December that every automated sample prep solution from QIAGEN has already an upgrade automation launched on the market, QIAcube, EZ1, EZ2 QIAcube Connect, and we are still working on an upgrade of our flagship instrument, QIAsymphony. Looking forward, in 2021, we expect continuous acceleration of our non-COVID sample technologies products quarter-over-quarter. Here again, we are focused on executing on a solid road map for this portfolio to drive our post-pandemic business, while, of course, being also prepared for any future pandemics. Let's spend some time on QuantiFERON. As you have seen, we have recently announced the CE marking of our new Lyme disease test for use on DiaSorin LIAISON platform. This new test addresses an unmet need for early detection of this very debilitating disease. It has been designed to support earlier disease detection, which is critical for those suffering from Lyme disease, with the goal to prevent severe illness in those infected with this bacterial disease. DiaSorin once again is the perfect partner for this test and to take over the commercialization given their portfolio of more than 8,000 instruments installed worldwide. The combination of QuantiFERON technology for the detection of T cell response with DiaSorin's existing assays to detect B-cell response offer a new level of clinical detection and a very innovative new level of clinical detection. This is indeed an attractive market as Lyme disease cases are constantly on the rise, especially in the U.S. and Europe. This is driving an increase in testing volumes year after year. In Europe alone, for example, more than 230,000 people are estimated to contract Lyme disease every year. On a global basis, the annual market opportunity is about $400 million to $600 million for Lyme disease testing. And as a next step, as we already announced, we are now going to work on the U.S. submission, and we will obviously keep you informed. The second part of our agreement with DiaSorin is obviously the continuous automation of our QuantiFERON solution. As a reminder, we have developed options for customers to create fully automated workflows for the QuantiFERON-TB test using LIAISON system. This allows QIAGEN to reach new customers through new commercial channels, while offering, at the same time, DiaSorin with a differentiated test to embed in their broad menu. Beyond the existing successful cooperation on the LIAISON XL instruments, the large volume system, QIAGEN and DiaSorin have commercial actions now centered on the lower volume LIAISON XS platform. The partnership with DiaSorin is really, really gaining traction in the U.S., and we are looking for recovering strong trends in Europe as well once the pandemic subsidies. The latent TB market is returning to growth after the pandemic pressures in 2020. And as you have seen, with sales rising 22% at constant exchange rate in the first quarter of 2021. The real competitor is the tuberculin skin test given that only 25% of the more than 70 million global latent TB tests are converted to modern blood-based testing. So there are still significant greenfield conversion opportunities. Our automation strategy enables us to target a wide range of mid to high throughput laboratories in any market. Also, the launch of our QIAreach TB is coming out soon for this year, which is a version of our QuantiFERON-TB test for low resources, high burden countries. And this test will run on a small device that can be used in the field with battery power. So we are on track to achieve our 2021 sales goal for over $230 million for the QuantiFERON franchise. Our partnership with DiaSorin is bearing fruit and helping us to expand in both industrialized and emerging markets. Moving now to the appointment of a new Supervisory Board Member. I'd like to introduce you to our newest Supervisory Board Member and welcome Thomas Ebeling to QIAGEN. Thomas joined the Board in February and brings with him a wealth of experience in international management, particularly in health care, given his previous roles as CEO of the German media company, ProSieben, and Division CEO role at Novartis involving pharmaceuticals and consumer health. With the addition of Thomas, the Supervisory Board of QIAGEN now has eight members. I'd like now to hand back to Roland.