Dr. Jurgi Camblong
Analyst · Morgan Stanley
Thank you, Katherine, and good morning, everyone. We appreciate you joining us on our call today. I am pleased to share that our third quarter results came in strong with revenue for the quarter growing 37% year-over-year on a constant currency ex-COVID basis. Moreover, we achieved this growth while delivering meaningful expense reductions from the prior year period. Our operating loss on an adjusted basis was $11.8 million, an improvement of $7.5 million or 39% from the third quarter of 2022, an improvement of $2.8 million or 19% from the prior quarter. On today's call, I will start by reviewing our progress in the third quarter as it relates to our business execution and the continued growth of our SOPHiA DDM platform. I will then turn it to Ross Muken, our Chief Financial Officer and Chief Operating Officer, to share our financial results for the period in more detail followed by our outlook for 2023. We will then end by taking your questions. Let me start with a review of the third quarter highlights and the execution of our business strategy overall. At SOPHiA GENETICS, we are focused on driving the adoption of our SOPHiA DDM platform. SOPHiA DDM is a cloud based software-as-a-service platform that health care institutions analyze and generate insights from patient data. SOPHiA DDM applies artificial intelligence to complex patient data, including genomics and radiomic data to help customers identify valuable patient insights. Our platform provides insights on a wide range of diseases with applications spanning across oncology and rare inherited disorders. A key attribute of SOPHiA DDM platform is that we leverage our network of connected customers to create flywheel effect. As more customers use our platform to generate patient insights, the more powerful our insights become for the next patient. Customers who use SOPHiA DDM are constantly uploading patient data to the platform and providing inputs as they apply their expertise. As customers upload more data and provide more inputs, the AA algorithms which powers SOPHiA DDM become stronger over time. Ultimately, this allows health care institutions to benefit from the expertise and knowledge of one another and contribute to the collective intelligence of SOPHiA DDM. In the third quarter, we made great strides towards driving further adoption of SOPHiA DDM. First, we added 18 new logos to our network. These customers join our more than 750 customers worldwide who use SOPHiA DDM, out of which 431 are core genomics customers. As a reminder, core genomic customers are those who generate revenue through our SOPHiA DDM platform in the last 12 months through our dry lab, bundle and integrated access modes by uploading their patient genomic data to generate insights. We aim to increase the usage of SOPHiA DDM by landing new customers and then expanding their usage of the platform. In that regard, our strong Q3 revenue performance is driven by robust utilization of SOPHiA DDM across the board. For the third quarter of 2023, analysis volume across our core genomic customers, which can be considered a close proxy for the number of patients analyzed, was 79,784. This represents an all-time high and is up 28% year-over-year. When excluding COVID-19 related analysis, platform analysis volume was 78,709 for the third quarter of 2023, up a very robust 36% year-over-year. As mentioned earlier, customers use SOPHiA DDM to generate data-driven insights for patients across 2 primary disease areas, oncology and rare and inherited disorders. For oncology, we offer SOPHiA DDM applications for hereditary cancer testing, solid tumor profiling and hematological malignant testing in addition to the newer applications we added in the market for homologous recombination deficiency, HRD, and liquid biopsy. On that note, the later applications, HRD and liquid biopsy, were the fastest growing in the quarter while more established applications like hereditary cancer grew in line with our company's overall growth. For rare and inherited disorders, we offer applications to cover a wide range of diseases. Exome analysis represents the fastest growing applications in this area and we are expecting to see a shift to larger gene panels over time. Overall, we saw both the oncology and rare and inherited disorders categories grow in line with our company's overall growth and reflect strong year-over-year performance while COVID analysis were down year-on-year as expected. I will now share some highlights during the quarter across our geographies. In EMEA, I'm excited to highlight 3 customers from the third quarter who are using SOPHiA DDM to generate insights for their oncology patients. First, we recently announced 2 new customers who were attracted to SOPHiA DDM by the impressive analytical performance of our platform and specially by our new homologous recombination deficiency application. In August, CHU Bordeaux, one of the largest hospital in France went live on SOPHiA DDM and will be using our platforms HRD application capabilities. In addition, Istituto Romagnolo per lo Studio dei Tumori, IRST, an oncology center in Italy went live on SOPHiA DDM in September and is also using our platform's HRD detection algorithms to help provide personalized treatment for patients with advanced ovarian cancer. In October, we also announced a new logo with OnkoMedeor Diagnostics, a German-based hematology-oncology clinical lab, who will use SOPHiA DDM's hematology application capabilities for chronic lymphocytic leukemia, CLL, a common type of blood cancer. We welcome these new customers to the SOPHiA DDM network and are excited to work with them for their oncology needs as well as them contribute their data and knowledge to the SOPHiA DDM community. In the LatAm region, we announced that we expanded our relationship with laboratory Laboratorio Curie, a laboratory in the capital city of Paraguay. Laboratorio Curie became a SOPHiA DDM customer in 2022 using the hereditary cancer application of our platform. This quarter they expanded their use of SOPHiA DDM by adding our HRR application for solid tumor testing. Laboratorio Curie cited that the SOPHiA DDM's today expected turnaround time for this application will help accelerate reporting and decision making. In the Asia Pacific region, analysis volume in the third quarter grew above company average benefiting from September of 2022 signings when we added 2 labs in India, Unipath Specialty Laboratory and MedGenome. These labs in addition to the Tata Institute of Genetics and Society Center at inStem have all now completed their onboarding and are using SOPHiA DDM to run about 12,000 analysis per year. These large volumes in India are notably beyond what we see in other parts of the world and are underpinned by India's large population size albeit at a price point established to suit the Indian market. In the Asia Pacific region, we now intend to build on these early successes in India and in Australia with Peter Mac, which we discussed in detail last quarter, and are looking to push into new territories such as Korea and Japan. We intend to leverage direct and indirect sales. In doing so, expect to add small number of sales headcount in the region. Next turning to NORAM. We are pleased with the solid progress we are making in the region. NORAM revenue growth accelerated sequentially and grew at an impressive 78% year-over-year, well above the company average. NORAM benefited from above company average analysis volume growth as well as contribution from biopharma. We continue to be excited with our growth in NORAM, which we consider to be a relatively underpenetrated and high potential market for us. I would like to take this time to highlight 3 new customers we signed in NORAM this quarter. In Canada, we signed CReATe Fertility Center in Toronto will be using SOPHiA DDM for fertility testing. And in the U.S., we signed [indiscernible] in Seattle and BioReference outside of New York City that serves over 19 million patients annually. Both of those reference labs are adopting SOPHiA DDM for liquid biopsy applications, which I'm excited to talk about in more detail now. As you know, liquid biopsy technology has the potential to revolutionize the diagnosis and management of cancer. Today, liquid biopsies are being investigated across 3 main use cases. First, for diagnosis and therapy selection for cases in which obtaining a biopsy of the primary tumor is not feasible, for example, in subset of advanced lung and prostate cancer cases. Second, for the longitudinal monitoring of response after onset of systemic anticancer treatment. And third, for early detection of cancer. However, these promising use cases do not come without challenges. Liquid biopsies require highly sophisticated analytical capabilities to overcome the number of signal detection challenges such as low input materials. We believe this is an area in which our algorithmic capabilities may be distinctive. Our analysis of over 1.4 million genomic profiles to date means that we can confidently pick the signal from the noise. In addition, we have developed our own proprietary molecular barcoding technology required for liquid biopsy analysis named CUMIN, which grants us freedom to operate in this important area. Both [indiscernible] and BioReference have recognized the analytical performance of our liquidity applications and we're excited to welcome them to our network. In addition to these U.S. customers, we also recently helped Centre Leon-Berard, a leading cancer center in France, adopt SOPHiA DDM for liquid biopsy testing needs. Overall in Q3, our liquid biopsy analysis volumes grew 80% granted off a small base and we look forward to seeing this trend continue as we bring on new customers. Speaking of expanding our liquid biopsy customers, I would like to take this opportunity to talk about our partnership with Memorial Sloan Kettering. As previously announced, we recently entered into a partnership with MSK to help them commercialize and deploy their liquid biopsy assay MSK-ACCESS. MSK-ACCESS is a liquid biopsy test that MSK developed in 2019 and successfully implemented clinically over the last 4 years at their New York facilities performing over 10,000 analysis to-date. This has been a resounding achievement for MSK and they are facing a lot of demand for their tests. However, they do not have the capacity to materially ramp up their testing volumes. Earlier this year they turned to us with the shared vision of working together to decentralize the MSK-ACCESS test and bring it to the world. The cloud-based nature of the SOPHiA DDM platform uniquely positions us to automatically break the data failures created by the centralized on-premise solution and bring their vision of deentralization to reality. We are currently in the process of working with MSK to decentralize and commercialize their liquid biopsy test MSK-ACCESS powered by SOPHiA DDM and make it available to customers across the globe. Customers around the world will be able to use SOPHiA DDM to run MSK 146 gene panel that analyzes match genome and their samples and pick the signal from the noise. Participants to our early access program will be able to use SOPHiA DDM before the end of 2023 with full commercial launch on track for the first half of 2024. In fact by reference, the New York City lab we announced earlier today is one of the first adopters of MSK-ACCESS through this early access program. In addition to this initial traction, we also announced ahead of ESMO in October that AstraZeneca will join the collaboration between us and MSK to help bring MSK-ACCESS to a global scale. AstraZeneca will leverage its global footprint to help accelerate the deployment of MSK-ACCESS worldwide. In doing so, institutions around the world, including those in under-resourced and underserved areas with access to highly accurate and reliable data and insights. Beyond improving global health equity and enabling proper cancer testing, the network we're building with MSK will also be very important to accelerate standard recruitment of patients for clinical trials and in partnership with biopharma companies accelerates the development cycle of new compounds in oncology. Having now covered the opportunity in liquid biopsy, let me move to a second fast-growing application area HRD. Identifying patients with homologous recombination deficiency, HRD, means identifying a biomarker that has been shown to be associated with response to PARP inhibitors in advanced ovarian cancer. Since the launch of HRD detection capabilities on SOPHiA DDM last year, we have seen sustained strong growth in analysis volumes. We have now approximately 35 customers in routine usage globally and in the third quarter we added Peter Mac in Australia to the list of countries using SOPHiA DDM for HRD detection; which includes India, Brazil, Italy, France and Spain. We recently expanded our HRD offering covering CIBD and RU applications by offering a patented analytical algorithm named Ginger. Ginger is a deep learning algorithm that powers our HRD detection capabilities. This algorithm uses low path wall genome analysis in conjunction with our proprietary deep learning algorithm to detect patterns of genomic scarring across the genome and as a result of mutations associated with homologous recombination repair. Ginger is technology agnostic and can be readily deployed on any wet lab library prep, including third-party CGP panels. Overall, we are very happy with the traction of our HRD application today. In addition to our positive momentum in the clinical space, biopharma continues to show interest in SOPHiA DDM for HRD and HRR testing applications notably in the context of liquid biopsy testing. Today, I spent a lot of time highlighting the process we have made selling the genomics capabilities offered by SOPHiA DDM. While the genomics offering you've heard about today such as our HRD and liquid biopsy applications continue to be the key focus, we have always intended to complement this genomic capabilities with multimodal analysis. I am pleased to update you on our progress towards this multimodal vision. During the third quarter, we released the multimodal model of the SOPHiA DDM platform SOPHiA CarePath. SOPHiA CarePath provides customers with the ability to perform multimodal and longitudinal analysis of patient data. In order to ensure SOPHiA CarePath gets off a strong start in the market, in December of 2021 we initiated a multimodal clinical study called DEEP-Lung-IV. As a reminder, this flagship initiative is a real-world observational study to develop AA powered multimodal predictive models of response to immunotherapy in the context of Stage 4 nonsmall cell lung cancer. Using the study as a springboard, we have now activated SOPHiA CarePath at all 30 of the sites we are participating in the DEEP-Lung-IV study and have recorded data on the 2,000 patients enrolled to-date. Researchers from those 30 institutions are now using Sofia CarePath to develop new clinical research hypothesis by accessing the study data in a statistical aggregated manner. On that note, we are currently working on a first plan interim analysis of around 600 patient cases, which will be reviewed by the study IDMC, an Independent External Data Review Committee, by end of this year. This will notably be the opportunity to have a first readout regarding the performance of the predictive models being developed and we are looking forward to updating you on the first results in Q1 2024. The progress that we've made to develop our multimodal capabilities could not have been achieved without the partnership of several key players in the health care ecosystem. In order to continue cultivating a community of joint collaboration, we proudly hosted the AI-driven Precision Oncology Summit in New York City in September. Attendees enjoyed 2 keynotes, 1 from Michael Burger of Memorial Sloan Kettering discussing our precision oncology with decentralized solutions and the second from David Gu, Chief Medical Officer of Microsoft, who presented opportunities and challenges with AI in health care. Then our Chief Biopharma Officer, Peter Casasanto, hosted a panel discussion with distinguished guests from AstraZeneca, Janssen, Henry Ford, Memorial Sloan Kettering and Microsoft with a focus on AI's potential for enhancing treatment decisions making and supporting development of novel therapies. Beyond this event, we attended ESMO, the European Society for Medical Oncology, where our meetings with prospects and customers focused on the excitement surrounding the recent press coverage of our joint announcement with AstraZeneca and Memorial Sloan Kettering to broaden the adoption globally of NGS testing with a focus on patient health equity. Our biopharma team hosted meetings with most of the Top 20 oncology companies to discuss the impact of this memorandum of understanding and potential for them to participate in the movement, enabling greater access to testing and eligibility for clinical trials and life-saving therapies. And just this past week, NVIDIA, our partner for rapid and scalable wall genome sequencing data analysis, joined us in Washington DC at ASHG to showcase our joint efforts. We look forward to continue working with all of our partners to advance our shared mission of improving our equity through data-driven medicine. Now turning to financial priorities. I want to address our recognition of the constrained environment for capital and reiterate that SOPHiA GENETICS has the ability to reach profitability without additional capital if necessary. We fully expect and will proceed with our forward budgeting under the scenario that will not be available. Our concerted efforts of cost containment are now in the sixth quarter of consecutive improvement, excellent recurring items. In the third quarter of 2023, our reported operating loss was reduced by 30% year-over-year and by 17% sequentially. On an adjusted basis, our third quarter operating loss was $11.8 million, an improvement of 39% year-over-year and 19% sequentially. I would like to emphasize we do not take this challenging environment lightly. As such, we continually inspect our spending for opportunities and improvement. To that point, I would like to share that we have identified incremental select actions that can further expedite our path to sustainability. We are just underway with these actions and expect benefits to 2024 and onwards. So to conclude my section. SOPHiA technology has been adopted by more than half of the 20 leading global cancer participants. As technology markets have shown us, winning the early adopters can be helpful in longer-term efforts to garner share with the majority. We are in the early days of the movement towards personalized medicine for cancer and our sense is that our momentum is increasing. And so in closing, I feel as excited today as ever that SOPHiA GENETICS has the elements in place that will enable us to accomplish what we set out to do 12 years ago to harness data from the global community, to generate actionable insights that contribute meaningfully to patient care and patient outcomes. And now I will turn the call over to Ross to discuss our financial performance in more detail.