Centogene N.V.

Thanks, Sarah. Hello and welcome. Thank you for joining us to discuss our Q4 and full year 2020 results, which were issued earlier today. You can view this presentation and the related press release on Centogene's website. For those unable to view the webcast, you can find the relevant slides on investors.centogene.com. Before we begin, please refer to the slide two of our presentation, which provides information about certain statements to be made today that may be considered forward-looking statements. within the meaning of the U.S. securities laws, including those regarding our strategic plans, development programs, and future financial results. Statements made during this call that are not historical statements may be forward-looking statements, and as such may be subject to risks and uncertainties which, if they materialize, could materially affect our actual results. The forward-looking statements in this presentation speak only as of today, April 15th, 2021, and we undertake no obligation to update or revise any of these statements to reflect future events or developments, except as required by the law. Additional information regarding these statements appears on our SEC filings. It is now my pleasure to introduce you to today's speakers, our Chief Executive Officer, Andrew Oswald, and Richard Stoffel, our Chief Financial Officer. Following our presentation, we will open up the call to Q&A. We kindly ask you to only ask three questions. I will now hand the presentation over to Andrin. Please turn to slide four. Andrin.

Thank you, Leonard. Hello. Good afternoon. Good morning, everyone. Today, I will begin by walking you through our operational performance during 2020. I will update you on the progress of our core businesses, meaning the pharma and diagnostic segments, and provide you with further insights into our company and its key assets. Richard will then take you through the financials, including what we have been able to achieve in our commercial COVID-19 testing segment. We will then provide our financial guidance for 2021 and the business outlook. Afterwards, we will open up for Q&A. Let's please turn to slide five. Well, let me first highlight the key messages for today. We had a very strong performance from a revenue perspective, having more than doubled in 2020 compared to 2019. The company surpassed 100 million euros in revenues for the first time in its history for a record year overall. Additionally, we have achieved a record adjusted EBITDA. Both revenues and adjusted EBITDA were driven by the COVID-19 testing segment in the second half of the year. I believe this is a truly impressive achievement and a credit to the strong performance of a dedicated working team at CentoGene, especially during a very challenging year. When looking at the core business, I want to underline that this is our firm focus for 2021 and beyond. Even though the core segments overall financials for 2020 reflect the headwinds from the pandemic, I'm pleased to say that our diagnostic segment continued recovering since the lows in the second quarter, and sample and order intake value in q1 2021 is approximately on par with q1 2020 and growing in pharma we signed 60 new collaborations in 2020 and the further 16 extensions of existing collaborations as such i'm confident that the overall core business is back on track for growth Looking at 2021, the positive financial contribution from our COVID-19 testing segment leaves us in a stronger financial position. These contributions have allowed us to make continued investments into our rare disease core business, Accentogene. Accentogene embarks on its next phase of growth. On that topic, I'm pleased to invite you all to our virtual investor event planned for June 22nd, where I will, together with the CentoGene executive team, provide further insights and discuss the company's strategy and future direction. Let us now discuss the company's 2020 performance. Please turn to slide six. In 2020, our revenues more than doubled compared to 2019, reaching 128.4 million euros. This increase was driven by COVID-19 testing, which accounted for 89.3 million euros for the full year and 59.8 million euros in the fourth quarter. We experienced headwinds for sure from the COVID-19 pandemic that impacted our core business segments, particularly in the second and third quarter of 2020. The core segments gradually recovered towards the end of the year, but did not match our prior year's performance overall. That meant that the full year revenues within the farmer segment decreased by 21% and within diagnostics by 19%. However, COVID-19 testing revenues have enabled us to more than make up for the headwinds in the core business. As we look ahead into 2021, I'm confident that we will return to solid core business growth. Now please turn to slide seven to have a closer look at diagnostics. Firstly, I'd like to share an update on the momentum in our diagnostic segment. The graph on this slide depicts the sample ordering take value for each quarter. Using Q1 of 2020 as a benchmark for pre-pandemic levels. You can clearly see the levels falling dramatically to approximately 50% of normal levels in the second quarter of 2020. showing the impact of COVID-19 pandemic. Since then, we have steadily seen levels of recovery each quarter to approximately 80% of pre-pandemic levels in Q4 2020 overall. And as already mentioned, I'm pleased to say that we have seen the trend to continue in Q1 2021 with sample order intake values approximately on par with Q1 2020 and growing. I believe this demonstrates the ongoing and increasing need for our testing services. In 2020, we maintained also and built our leadership further in rare disease diagnostics and continue to strengthen our superior scientific insights and knowledge. We laid the foundation for this by offering 55 peer-reviewed publications in 2020, which was a record year for SEM2GENE. This truly demonstrates our commitment to continuously unlocking further insights into rare genetic diseases. Some of the scientific achievements are shown on the slide. Many of them are proof points for increasing diagnostic yield with genome sequencing and how we are providing bioinformatics tools to enable best-in-class diagnostic interpretation. Furthermore, our research is aimed to uncover specific genotype-phenotype associations to understand novel causes and unknown syndromes. We view our contribution in better understanding rare diseases at the core of our commitment to patients around the world, aiming to provide the best in class diagnostic possible for rare diseases. And you can expect more of this in 2021. Please turn to slide eight. As explained, we saw a dip in the number of sample and order intakes in our diagnostic segment. This is true for the overall core business. as you can see here on the left side of the chart. However, we still make progress on growing our bio and data bank, which includes samples as well as data and cell lines. On the graph on the right, you see the number of individuals in our data repository. Over the course of a difficult 2020, we still added approximately 100,000 individuals to our rare disease-centric data and biobank, an increase of approximately 20%. In the next few slides, I would like to demonstrate how this biobank translates into valuable data assets. Please turn to slide nine. It is Antigen's mission to revolutionize the understanding of rare diseases by connecting patients and their biology. This allows us to address different use cases for value creation. Our biobank can be visualized as is here. On the outer layers, there are hundreds of thousands of individuals for which we have clear genetic information. This data drives our general knowledge on the underlying genetic constellations, which in turn builds up superior diagnostic insights and enables us to find and diagnose patients. One example of being able to provide value in the patient finding process was recently demonstrated regarding a sordid gene, a novel genetic cause of neuropathy. A global academic consortium recently identified 45 patients carrying a mutation in this gene. While this is a new genetic cause only just identified, central genes biobank already contains 42 patients, all with exome and genome sequencing performed, and most of them with HBO terms-based clinical descriptions. This truly demonstrates that we already have patients in our biobank, in many cases, are able to quickly respond and be ideally positioned to support R&D for finding new patients, even for new diseases. In addition to the growing size of the database, we also prioritize its quality. One reason we believe our data bank is unique, apart from its focus on rare diseases, is the unique linkage of phenotypical information and diagnostic findings. We ensure this through careful curation of the cases In a way, we measure the quality of the data descriptions through standardized HPO terms. The continuous improvements to the quality of the data and the phenotypical information is reflected by the increase of average number of HPO terms per patient sample in our database, up from five in 2019 to eight in 2020. Another example of the patient finding aspect of our databank are sponsored genetic testing collaborations like the one with Takeda. The program focuses on lysosomal storage disorders for which an enzyme replacement therapy exists, such as Sabric, Gaucher, or Hunter syndrome. The goal is to enable a faster path to identify patients via biochemical screening or genetic analysis and accelerate patients receiving a diagnosis and potential access to treatment. In a normal year, we screen approximately 40,000 to 50,000 samples for Takeda. And as announced earlier this week, we are pleased to report that we have extended our collaboration with Takeda in Q1 2021. When moving from the diagnostic use case to the acceleration of drug and therapy development, we are looking at the specific data points and tools that help identify biomarkers, genetic modifiers, and potential targets. These are the data sets for which we have more information available, superior description of phenotypes, research content in place, and complete genetic information as well as multiomic information. The middle layer displayed enables clinical trial support and patient stratification use cases. The recent example is the Denali Corporation on Parkinson's. At the core, you will see the areas we view as having full disease models available, which then also include cell models to be used for in vitro compound screening via stem cells. Each layer allows us to address different use cases internally and, of course, with pharma partners. On the next slide, I would like to highlight two in particular. Please turn to slide 10. A good example of a collaboration on the clinical trial case or the middle layer of the sphere previously shown is our ROPAT study. This global study demonstrates both our innovative capabilities and how it can be a value driver for patient and former partners and internal development. As a brief reminder, CenterChain entered into strategic collaboration with Denali Therapeutics for the target global identification and recruitment of Parkinson's disease patients with mutations in the LRRK2 gene in 2018. We were proud to announce recently that the study now includes over 10,000 participants from over 120 sites globally, which we believe to be the most comprehensive dataset on genetic Parkinson's disease today. We utilized our broad physician network, which is particularly strong in neurology, to successfully identify hundreds of patients with LARC2 mutations. The study also created further novel insights. We leveraged our biobank to analyze and predict consequences of reducing LARC2 function, an important element for our partner Denali Therapeutics, who is working on the LARC2 inhibitor. In fact, the rich data in our biobank already contained individuals with homozygous loss function and without clinical symptoms, which are especially valuable to Denali. Based on a large cohort of individuals for which exome and genome sequencing had been performed in a diagnostic setting and for a wide range of phenotypes, we did not find evidence for heterozygous or homozygous poor loss of function variants to cause any distinct phenotype. And thus, our data facilitated the conceptual novel confirmation of the safety of LRRK2 activity reduced treatment strategies in Parkinson's disease, fundamentally de-risking the therapeutic development of such inhibitors. On that note, I'm very pleased to announce that we have just signed an extension of the contract with Denali for another 2,500 patients. In addition, we also believe that this unique data set will be very valuable beyond LRRK2. including the potential to identify new disease modifier or targets for Parkinson's, an opportunity that we are exploring internally and also with other potential partners. Let us now please turn to slide 11. I would like to highlight the targeted drug discovery case here. You know that Gaucher is one of our focus areas where we leverage our deep data and biobank. In authoring numerous publications, we have shown that power of Lysol GP1 is a biomarker for diagnostics as well as a tool for monitoring treatment response and quality. Now we have a large cohort. We have over 1,800 diagnosed Gaucher cases in our data bank. Looking at the depth of the biobank, we have over 135 of last samples. and has built patient-derived tissue-specific cell models to allow us to continue to build a full disease model for Gaucher, thus enabling, accelerating, and de-racing therapy development. In essence, we went from clinical to the preclinical stage here. To this effect, we have set up disease models and the needed multilayer multi-omic tool. A disease model for us is the patient-derived tissue-specific cell model from stem cells established with relevant readouts. On the side of bioinformatic tools, we have generated better insights into Gaucher disease through an extended multi-omics disease map for lysosomal storage disorders by mapping Gaucher disease subtypes from gene to phenotype. Now, our clear ambition is that the core data set we create can be used to identify pathways, targets, and modifying genes. We have set up two work streams in this regard. First, we are looking at Lyso-GB1 as a well-known target. This is well underway as part of our partnership with Evotek, where they bring access to the large molecule library they own. We have evaluated the first chemical compounds in our disease model in 2021 and will continue these efforts in the coming months. The collaboration is built on co-investment and sharing of findings. The progress should be apparent in the next six to eight months. Additionally, we are also looking into another target discovery, exploring modifying genes. We anticipate that target mining and novel target identification will take 12 to 18 months. In the meantime, the research project here will drive the development of our multi-omics platform and capabilities, which will support the use case for all the disease areas as well. And of course, we won't stop at Gaucher. I believe our bio and data bank and its expansive physician network is uniquely strong in neuroscience, metabolic diseases, such as lysosomal storage disorders. The progress on gauche is something we are replicating other disease errors and we are prioritizing the next disease errors we believe we can do so. We will update you on those in the upcoming investor event. Please turn to slide 12. I want to give you a quick update also on our management team. We have restructured it to really better reflect the two core segments where we drive value in the future. In my mind has always had a fantastic thrive for science and following science. But we now want to pair the scientific know-how also with commercial know-how and competence. And to that extent, we have created leadership teams consisting of the commercial scientific leader for both our diagnostic as well as our pharmaceutical segment. Those teams will be jointly driving and the value creation of these specific segments going forward. They are, of course, supported by dedicated, highly skilled functions such as bioinformatics and HR. And in that regard, I want to give you also an update on two new members that joined us just recently. And first, I would like to introduce Nathalie Dust, who has joined CenterGene as our new Chief Human Resource Officer starting in March. Nathalie has a strong track record of developing talent, fostering company culture, and building required capabilities to achieve a company strategy. Over the past decade, she has spearheaded a number of large-scale projects in the talent era, such as building capabilities for livestock and farmer companies, focusing value, driving skills, and behaviors. I think this will be particularly important as we move forward to our next growth trajectory. I would also like to welcome Maximilian Schmidt. He recently joined us as Chief Commercial Officer, Diagnostics. Max will be responsible for Diagnostics business strategy and growth. He brings an entrepreneurial spirit, having worked at the Silicon Valley startup before they were acquired by Roche. At Roche, Max was a member of the global leadership team of its sequencing business unit before he joined us. You will have the opportunity to hear from the team directly at our investor event in June. Well, with that said, let me hand it over to Richard to walk you through the financials in more detail. Richard, over to you.

Thank you, André. Could I kindly ask you to turn to slide 14? Our full year 2020 revenues grew by an impressive 163% compared to 2019. This was largely driven by COVID-19 testing revenues, which brought in close to 19 million euros in revenues for the full year. The core business segments experienced headwinds due to the COVID-19 pandemic, particularly in the second quarter. and the financials for the core segments reflect the challenging year. The pharma segment recorded 17 million euros in revenues, a 21% decrease compared to 2019. The diagnostic segment recorded 22.1 million euros in revenues, a 19% decrease compared to the year 2019. While such results are disappointing for the core business, I believe the company was nimble and effective in its response to the circumstances as we made good use of our diagnostic capabilities. We are well positioned as we continue into 21 and we'll get back to solid core business growth to materialize Centogene's long-term potential in its core segments. The slowdown in revenues translated into a decrease in adjusted EBITDA for both core business segments. Nonetheless, we are pleased with the momentum in the pharma segment currently and look forward to this translating into revenues in 21. The adjusted EBITDA margin in pharma decreased to 37% for the year, as the diagnostic segment showed a solid recovery in the second half of the year. Fixed cost elements resulted in the adjusted EBITDA margin declining for the year overall to minus 11%. Having said that, I want to emphasize that if sample volumes had been at pre-pandemic levels, adjusted EBITDA for the diagnostic segment would have been positive for the year. The COVID-19 testing segment leveraged 42% adjusted EBDR margin for the full year. Even though we do not have a comparison to 2019, I want to note that such includes upfront expenses for the setup of our COVID-19 segment at the beginning of 2020. Consequently, adjusted EBDR margins improved in the third and fourth quarter as we increased the revenue substantially throughout the year. Now, let's look at a further breakdown of where revenues in our segments came from in 2020. Please turn to slide 15. As usual, we provide you with the breakdown of revenues in our farmer segment by new and existing contracts for the period. As a reminder, we define a new contract as one signed in the last 12 months. We are happy to report the signing of 16 new contracts in 2020. The majority of the 16 new contracts were signed in the second half and did not result in recognized revenues for 2020. Rather, we will see the revenues of deep contracts in 21 and therefore the revenues for new contracts presented here are not an accurate reflection of our farmer segments momentum. In saying that, we did see revenues from existing contracts increased by 10% in 2020 compared to 2019. While it is our goal to grow the farmer segment, it is nevertheless encouraging to see our existing collaborations bring in a robust revenue space, even in a year as challenging as 2020. Looking at the diagnostic segment, revenues from NIPT decreased in 2020 compared to 2019. As mentioned in previous quarters, NIPT is not a core focus of our strategy. Revenues from other tests decreased by 19% compared to 2019, which was due to the previously discussed headwinds to our diagnostic segment. As for the COVID-19 segment, we demonstrated a significant ramp up in each quarter in 2020, particularly in the second half of the year, which led to the substantial contribution to our top line for the year. Now, please turn to slide 16, where I will discuss the financials for the fourth quarter in more detail. Looking at our revenues for the fourth quarter of 2020, COVID-19 testing brought in 59.8 million euros. In addition, we recorded an adjusted EBDR margin of 45% in that segment, which was an increase from 35% in Q3 2020. Although COVID-19 testing is not strategic to our business long-term, the financial contribution from this segment will support us in making key strategic investments into our core segments. Shifting to our core business segments, in pharma we recorded €4.7 million in revenues in Q4, which was a 41% decrease compared to the same period in 2019. In diagnostics, revenues decreased by 19% compared to Q4 2019 to €5.8 million. These financial outcomes reflect the trends we discussed earlier in the presentations, whereas signed pharma partnership contracts will result in 21 revenues and diagnostics will continue recovering towards the end of the year. Let us now finish discussing other key financial elements for this period. Please turn to slide 17. Looking at our income statement, we have already mentioned the increase in revenues for a record total for the company of more than 128 million euros. Such increase in revenues drove an increase in gross profit of approximately 19.2 million euros in 2020 compared to last year. Our expenses, including other operating income, increased by approximately 20.2 million euros for the year compared to 2019. As a result, the operating result was lowered by approximately 1 million euros. Let me comment on the two biggest factors that drove this increase in expenses. Firstly, general administrative expenses increased by approximately 14.5 million euros. As mentioned last quarter, the increase in G&A costs are primarily a result of being a public company, such as D&O insurance, corporate governance, investor relations expenses, and share-based payment expenses. Naturally, we did not incur those costs in 2019. In addition, we incurred costs related to our COVID-19 testing efforts, including continuing to internally test our employees to keep the company operational, as well as some upfront costs related to test site expansions. Second, our R&D expenses for the year were up by approximately 5.3 million euros. This increase was driven mostly by personnel costs and IQ-related expenses. This is reflected on our continued commitment to advancing our biomarkers, databases, And technology platforms such as AI. It also emphasizes that although we experienced headwinds in our core segments this year, we did not lose focus of our long term strategy and mission of the company towards rare diseases. Now please turn to slide 18. Let us have a closer look at the cash flow and balance sheet. cash flow from operating activities improved significantly compared to last year. The additional revenues from COVID-19 testing and the healthy adjusted DBDR margin in that segment led to a positive cash flow. Looking at the change in cash flow used for investing activities compared to 2019, I would like to emphasize that the cash flow from investing activities last year included a net positive cash flow of 21.3 million euros from the sale and leaseback of our Rostock headquarters. Taking that into account, The negative cash flow originated from our investments in PP&E and right of use assets, mainly related to starting our COVID-19 segments, including the development of our Corona test portal. Cash flow from financing activities decreased compared to 2019, as our IPO in 2019 resulted in roughly double the raise when compared to our full-on equity offering in July 2020. As of December 2020, we had 48.2 million euros of cash and cash equivalent on our balance sheet, which I believe is a strong financial position for a company the size of Sandstreet. Regarding our outstanding debt, I would like to remind you that as of year end 2020, this includes more than 21 million euros of lease liabilities. Having looked at our performance for 2020, let me now update you on our financial guidance for 21. Please turn to slide 20. Finally, firstly, let's start with our core business. We have seen the core business segment recover towards the end of 2020 and into 2021. As such, we believe we can return to solid growth in our core business. Moving to our COVID-19 testing segment, we will continue leveraging the contribution from that segment. As uncertainties remain around the vaccine rollout, it is possible that demand may be different than we perhaps expected. Based on the current trajectory, we anticipate revenues from the COVID-19 segment in 21 to be approximately the same level as in 2020. Now, let me hand it back to André for a 21 business outlook. Please turn to slide 21.