John West
Analyst · Morgan Stanley. Your line is now open
Thank you, Caroline. In spite of the pandemic, Personalis has continued to grow. Personalis achieved record revenue during Q4, our 18th consecutive quarter of revenue growth. For the full year 2020, we also achieved record revenue and grew 21%. Our performance over the last several months highlights our ability to execute and also the resilience of our business. This results from our ability so far to shift our focus and capacity between our biopharma and population sequencing customers. Focusing on our revenue from biopharma and all other non-VA customers, during Q4, we grew 33% sequentially and 73% from the same period of the prior year. In the fourth quarter, we had a few projects where customers required completion before the end of the year, so they could use the data quickly. This customer push helped us achieve a new record level and highlights our ability to turn around test results quickly and support our customers as well. While we may not achieve quite that level of revenue in Q1, we do feel that our Q4 record reflects a longer term growth trajectory, evidenced by the orders we have received from these customers. In every quarter since mid-2019, the aggregate value of orders we have received has exceeded the revenue reported. For the full year 2020, orders were approximately 80% higher than 2019. Because of this order strength, entering 2021, our backlog was approximately double the amount at the start of 2020. In Q4, orders continued above our revenue level. And so far in Q1, the dollar value of orders we have already received exceeds the revenue we expect in the quarter. We believe we are winning pharma business based on the value proposition of our NeXT platform’s technology and capability and also our ability to service customers well. This underscores our confidence in future revenue growth. We expect our oncology business to become a larger part of our revenue mix in the future by leveraging our combined ability to analyze both tissue and liquid biopsy samples. Tissue samples, in particular, give us access to RNA and to the immune cells which have infiltrated the tumor. Liquid biopsy samples give us much easier access to multiple time points. We believe that the combination provides a system which is better than either alone. From tissue, we can deliver results using our exome scale ImmunoID NeXT and NeXT DX platforms and also offer whole genome sequencing. For liquid biopsies, we now offer three options. First, our NeXT liquid biopsy can assay the whole exome at multiple time points, particularly for discovery of new tumor escape mechanisms under therapeutic pressure. Second, NeXT Personal, which we plan to introduce in 2021, is expected to assay up to several thousand loci, combining the power of the tumor-informed approach with fixed content to look for new mutations, which may emerge as the tumor progresses. Third, a partnership with Natera in which we will provide them with advanced exome sequencing and diagnostic testing based on tumor tissue samples. Natera plans to use this data to identify somatic variants for their Signatera liquid biopsy test. We believe these three liquid biopsy offerings work together to accelerate Personalis growth in the monitoring of cancer progression. I will now provide more detail on our progress and plans for each. First, our exome scale liquid biopsy product for biopharma customers complements our tissue-based offering. Discussions with our existing and potential new customers are going well. We have received orders from several customers now and expect to fulfill these orders as we receive customer samples. You may recall that both our tissue and liquid biopsy-based products have been designed specifically to meet the needs of our pharmaceutical customers and provide data on all 20,000 human genes. Monitoring is rapidly becoming a key facet of long-term cancer care. Our first liquid biopsy product tracks the evolution of what can be hundreds or even thousands of cancer mutations in a single tumor and importantly, can detect new mutations as they emerge under therapeutic pressure. We expect to – we continue to expect initial sales of our liquid biopsy product to predominantly be to customers using our tissue-based testing who also want to monitor patients over time and indeed, that is where current conversations are focused. Second, later this year, we plan to launch NeXT Personal, our MRD offering that will be designed for each patient’s specific tumor. We believe this offering will enhance tumor tracking for patients due to its high sensitivity and its ability to identify thousands of mutations compared with competitor panels that can identify and track only hundreds or less. Our biopharma customers will be able to use NeXT Personal for multiple time point monitoring, and we believe that it will also be applicable for the diagnostic market in the future. Although we have not provided revenue estimates for our liquid biopsy offerings, we believe that with multiple time points per patient, we have a tremendous opportunity to grow revenues in this area. Third, we announced a commercial partnership with Natera earlier this month, and it’s a great opportunity for us to showcase the strengths of our technology and capabilities. Personalis will provide front-end tissue exome sequencing services for Natera, who will identify variance they will use to design their Signatera personalized liquid biopsy test for cancer patients in both a clinical setting and/or for their biopharma customers. Let me describe some of the benefits of this Natera partnership for Personalis. First, working with Natera further validates our NeXT platform as a best-in-class tissue sequencing front end, capable of detecting mutations in cancer that conventional exomes often miss. Second, it provides us with an incremental revenue opportunity from clinical diagnostic tests without any reimbursement risk. Third, this partnership allows our highly differentiated NeXT exome to be featured in a clinical setting earlier than if we only pursue this market ourselves. This partnership also complements the traction and adoption we have achieved thus far with our biopharma customers. Now, I would like to give you an update about other elements of our progress and how we have been executing on our plan. In January, we raised approximately $162 million, net of underwriter discounts, fees and expenses, from a follow-on equity offering. That further strengthens our balance sheet, so we can invest in initiatives to continue our growth. In December, we launched our SHERPA, new antigen characterization capability, which is a module incorporated within our NeXT platform and enhances the features. We believe that neoantigens are the crucial center piece of a new generation of companion diagnostic biomarkers. We expect our biopharma customers will apply this capability to mainstream cancer drugs such as checkpoint inhibitors and also to experimental personalized cancer therapies, which explicitly target neoantigens. This project has required multiple proprietary technologies, including genetic engineering of proprietary human cell lines, mass spectrometry to identify and quantify peptides binding to HLA and the training of novel machine learning algorithms. Our customer base has broadened substantially over the last year. We have now received orders from a majority of the top 10 oncology-focused pharma companies. Since we introduced the NeXT platform in 2019, as of the end of Q4, we have received NeXT orders from 45 different customers, up from 39 at the end of Q3. We believe that this growing adoption of NeXT further highlights the power of our platform and that comprehensiveness is important to our customers. Over the past couple of quarters, we highlighted some of our initial plans to establish a lab and commercial operations in the People’s Republic of China and partner with Berry Genomics. Our team is currently working to build out our laboratory in Shanghai and we are also hiring additional employees. Customer engagement is very good. We are just beginning to understand how the use of our exome-scale data will be viewed under China’s regulations on human genetic resources, which went into effect in 2019. We continue to expect that our operations in China will begin in 2021 with moderate revenues and begin ramping in 2022. While this project will take some time to meaningfully contribute to our top line, we believe this is an important investment. We look forward to updating you on our progress in the future. Earlier this month, we announced the hiring of Susan Moriconi as VP of People and Chief Human Resources Officer. In her prior experience at Omnicell, the company grew from 800 to over 2,700 employees, expanded office locations from 5 to 19 locations in 9 countries, while company revenues grew from approximately $250 million to almost $900 million. We believe her experience will be extremely valuable to Personalis and as we expand our employee base and continue to scale our company. I would now like to update you on the population sequencing part of our business, which is sometimes referred to in the field as population genomics. We are in the process of building a funnel of opportunities, and we are in early discussions with several of these prospects. Initial discussions are going well and are encouraging. We expect that we will have additional customers and revenue in 2022. Our work with the VA MVP represents the largest population sequencing effort within the United States. The VA now targets enrollments of 2 million veterans and over 825,000 veterans have enrolled so far. Personalis has been contracted so far to sequence over 147,000 VA MVP samples with approximately 42,000 remaining to be sequenced. We have been a good partner and the sole provider for the VA MVP’s whole genome sequencing project over the last 8 plus years and over multiple contracts. During more normal times, the VA MVP would initiate an RFP process during the summer months and then award a contract and task order by late September, the timing of which correlates with their fiscal year-end. 2021 is not a normal year. The VA has been focusing a lot of time and funds towards COVID-19, testing, treatment and now vaccinations. It is not entirely clear what the VA MVP process for contract renewal will be in 2021, but we believe that our scale, quality and service levels over the years puts us in a good position to win new business going forward. We will share additional information with you when their process becomes more definitive. In December, we announced that we have become the first for-profit company to sequence more than 100,000 whole human genomes in the United States, which was an important milestone for us. We expect that total to grow to more than 150,000 whole human channels by the end of 2021. Some will be for population sequencing such as the VA MVP and others will be cancer genomes. We expect our unparalleled experience and scale with the VA MVP program to position us well for new opportunities in population sequencing. Given our clinical experience and work with pharma, we also see an opportunity to help transition population research to population health and to involve pharma in the future. I would now like to expand on the synergy between the population sequencing and oncology parts of our business, in particular, those that go beyond the more obvious operational and cost synergies. Our extensive experience with whole genome sequencing, combined with our deep expertise in cancer, has allowed us to launch whole genome sequencing from cancer samples. We believe that this will be increasingly important in the future, particularly in cancers such as breast and prostate, which have relatively low mutational burdens. Using our cancer whole genome technology can identify up to 20x more somatic variants to serve as the basis for personalized cancer assays. We believe this will let us achieve high sensitivity even in cancers which have low mutational rates, which have been surgically resected or which shed relatively low amounts of cell-free DNA into the blood. We believe this can be a leading technology in some very large market opportunities, and we’ll have more to say about this as these product developments progress. In summary, I am very proud that our business has continued to show strong resilience throughout the pandemic so far and across our multiple revenue streams. Customer interest and adoption of NeXT has been excellent, and our pipeline of compelling new products is rich, and we have the capital required to invest in our growth initiatives. Together, this puts us in a strong position for both near- and long-term growth. With that, I will now hand it over to Aaron for our financial results.