John West
Analyst · Morgan Stanley
Thank you, Caroline. Q1 was our first quarter dealing with the impact of COVID-19. When we saw the COVID-19 epidemic expanding, we took action to accelerate the processing of samples in the population sequencing part of our business, both to make sure we could achieve our overall goals for the quarter and to leave as much lab capacity as possible for pharma samples which might be delayed. We did experience some delays, but we were still able to achieve $4.4 million in revenue for biopharma and all other customers which was within the range we had planned for the quarter. In part because we had accelerated processing of samples in the population sequencing part of our business, our revenues with the VA MVP program achieved a new high of $14.8 million. As a result, our total company revenue reached $19.2 million, our 15th quarter of sequential growth and a new record high. We have received strong orders in our biopharma business starting in Q3 last year for the launch of our NeXT platform. In Q1, we received new biopharma orders totaling more than 3x our biopharma revenue in the quarter. Those orders included a large order from a single existing customer. We do not expect that order to repeat every quarter. But even if we exclude it from our Q1 orders, our order amount would still be well above our Q1 revenue. Our population sequencing and biopharma businesses share a unifying theme in the comprehensive and large-scale genomic characterization of human samples. Both of our whole genome sequencing and our NeXT platform cover all 20,000 human genes. Because of their shared underlying technologies and the operational implementation, we achieved considerable synergy between the two businesses. Next, I would like to provide some additional updates on the impact of COVID-19 on our organization. First, we are focused on the health of our employees and our community. We have been under shelter-in-place orders since March 17, which now extend at least through May 31. Most of our employees are working from home. Our laboratory is staffed to run samples at reduced capacity with appropriate safety and social distancing measures. Our commercial team is still engaged with our customers. We received a record biopharma – we received record biopharma customer orders in Q1 and remain encouraged by engagement and order flow in Q2. We continue to receive pharma customer samples though with some delays. We received record batches of samples from the VA during the month of April, and assuming we can maintain adequate staffing of our lab, we expect they will keep us busy for most of the rest of this year. Our cash level puts us in a position of strength. We remain focused on adoption of our NeXT platform, development of new products and supporting our customers. Shifting focus to our progress this quarter, there are several factors which give us confidence in the long-term growth of our business. In Q1, we continued to scale, delivering over 14,000 whole human genomes, which is more than a 90% increase from Q1 of last year. We have now delivered more than 1,000 genomes from cancer samples and, in Q1, also completed sequencing our 100,000 sample overall. The potential value of new orders received from biopharma and all other customers was more than three times the amount of our biopharma revenue in Q1, and new orders have now increased sequentially since Q3 2019. In April, this trend continued with orders again exceeding revenue from our biopharma customers. As we’ve explained before, it takes time for orders to convert to revenue and the actual revenue recognized from an order may be less than expected due to the failure of individual customer samples to meet our sample quality requirements and other factors. But this growth in orders gives us confidence in our future revenue stream. As of the end of Q1, 26 different customers have now placed orders for NeXT, up from 19 at the end of Q4. We continue to be happy with how NeXT is being adopted by our existing and new customers. While it will take time for new customers to complete pilots, we are pleased with the number of customers engaged and look forward to deepening our relationships. We are establishing a lab and commercial operation in the People’s Republic of China. Several global pharmaceutical companies have asked us about China, underscoring our belief that it’s a good time to expand there. In January, before the COVID-19 disruption, members of our management team traveled to China to start this process. We continue to build our commercial team in both the U.S. and Europe, which has grown by 50% since our IPO. In particular, we have added business development staff with extensive commercial experience in companion diagnostic development. And as a result, we are now engaging with an increasing number of pharma companies for potential companion diagnostic development programs. We’ve also expanded our quality and regulatory team to support these efforts. In April, we applied to the FDA for a presubmission meeting for a single-site PMA for NeXT. This represents another investment we are making for our future growth. We are also leveraging the technology we developed for cancer to capture opportunities outside of cancer. For example, it is beginning to be appreciated that neoantigens can be created outside of cancer. In Q1, we were contracted by a major biotechnology company to apply our proprietary neoantigen bioinformatic expertise to their non-cancer gene therapy drug development. We have also announced our pharma research solutions, a suite of DNA sequencing and data analytics to support pharmaceutical development across a wide range of disease indications. Personalis had a total of 10 scientific posters accepted for presentation at this year’s AACR and ASCO conferences, continuing our scientific leadership in the field. These are listed on our website under Conferences, and they will be presented online in May and June. In March, we welcome Steve Moore as our new General Counsel. Steve has a long career at state-of-the-art companies in the genomics field. He was most recently at Pacific Biosciences as General Counsel, having joined them in 2010 when modern DNA sequencing was in its infancy. Prior to that, he was at the consumer genomics company, Navigenics, and before that, spent many years at Affymetrix. Welcome, Steve. I’d now like to update you on the population sequencing part of our business, which is sometimes referred to in the field as population genomics. Our work with the VA MVP represents the largest population sequencing effort within the United States. The VA now targets enrollment of 2 million veterans, and over 825,000 veterans have enrolled so far. Since 2013, Personalis has completed sequencing whole human genomes from over 60,000 VA MVP samples. Personalis has been contracted so far to sequence over 116,000 VA MVP samples. In Q3 2019, we received our largest VA MVP order ever. And later this year, we expect to begin work on it. With the large shipments of samples we have recently received, we now have all of the samples in-house that we will need to complete the 100,000 whole human genome for the VA. If we kept sequencing at the rate we achieved in Q1, we would expect to complete that 100,000 genome for the VA MVP by the end of this year. However, given the challenge of COVID-19, our sequencing production rate is uncertain. We think it is possible, though that Personalis could become the first for-profit company ever to sequence 100,000 whole human genomes in the United States. Since the VA has recently doubled the number of veterans they plan to enroll, we believe this program is likely to continue for many years. We expect our unparalleled commercial experience with the VA MVP program to position us for other opportunities in population sequencing. Given our clinical experience, we also see an opportunity to help transition population research to population health. We have already received population sequencing orders for over $145 million, and we plan to expand our commercial team to address what is projected to be a multibillion-dollar market. I’d now like to update you on three proprietary new products. First, in January, we launched our diagnostic readout on NeXT, called NeXT Dx, to be used by biopharma customers in clinical trials and by research collaborators. The core of NeXT Dx achieves over 1,000 fold DNA sequencing coverage in cancer driver genes, enabling sensitive detection of companion diagnostic biomarkers that have already been approved by the FDA on other platforms. We believe that this may eventually qualify NeXT Dx for reimbursement under an existing CMS national coverage decision, which could be very helpful for Personalis' customers seeking to develop companion or complementary diagnostics with our platform. Because NeXT Dx is based on the same underlying NeXT platform, for samples where a NeXT Dx report is generated, we expect to also provide our pharma partners with additional data covering all 20,000 human genes and a broad range of biology outside the coding regions of the genes, inaccessible by a standard exome. This rich biological content coverage would make NeXT particularly suitable for database development both by Personalis and Personalis' customers. Lastly, the broad footprint of NeXT allows it to capture more cancer mutations. This would make it an ideal front end for liquid biopsy products, which can subsequently use those variants for tracking tumor evolution. That brings me to the development of our liquid biopsy product line. Our first product in this product line is expected to be for use together with our tissue-based assay. Both our tissue and liquid biopsy-based products provide data on all 20,000 human genes. But with the addition of the liquid biopsy product, we expect to enable monitoring of patients that comprehensively at multiple time points. Many new cancer drugs extend the lives of patients but do not eradicate the disease. Thus, a growing segment of the cancer survivor population consists of patients who are still undergoing active disease management. Our exome-scale liquid biopsy product is being designed to track the evolution of what can be thousands of cancer mutations in a single tumor. And importantly, it is expected to be capable of detecting new mutations as they emerge under therapeutic pressure. This would represent a significant expansion of our addressable market, serving pharmaceutical companies, building our database and increasing clinical opportunities. While COVID-19 has impacted our R&D lab staffing, we still plan to launch our liquid biopsy product this year. Lastly, we have been working over three years on a combined laboratory and informatics project to advance our neoantigen characterization capabilities. We believe that neoantigens are the crucial centerpiece of a new generation of companion diagnostic biomarkers. We expect our pharma customers will apply this capability to mainstream cancer drugs, such as checkpoint inhibitors, and also to experimental personalized cancer therapies which explicitly target neoantigens. Our new advanced capability may also be used for development of drugs that are designed for use outside of cancer, such as gene therapies. This Personalis R&D project has required multiple proprietary technologies including genetic engineering of proprietary human cell lines, mass spectrometry to identify and modify peptides binding to HLA and the training of novel machine learning algorithms. Our data shows that this project has achieved a leapfrog advance in this field. We expect to launch this capability as part of our NeXT platform before the end of 2020. In summary, Personalis continued to receive strong orders from our pharmaceutical and biotech customers, continued to build commercial capability and has a great suite of new products already launched and with more to come. We believe that together, these factors, among others, put us in a strong position for long-term growth. While COVID-19 is causing some delays, our population sequencing business, with its backlog of orders and samples that we have already received, helps support us near term. That, combined with our strong cash position, lets us continue investment in our future growth initiatives. I will now hand it over to Aaron for our financial results.