Chad Robins
Analyst · Bank of America. Your line is now open
Thanks, Karina. Good afternoon, everybody. And thank you for joining us on our 2022 fourth quarter and full year earnings call. As always, I want to thank all of our Adaptive employees for their dedication and strong execution throughout the year. As you can see on Slide 3, 2022 was a year of key decisions and achievements for Adaptive. We started with the reorganization of the company around two business areas, MRD and Immune Medicine. We established clear strategic goals for each of these two business areas and executed against these goals by hitting key deliverables throughout the year. Following the restructuring, we shared our long-range financial plan to achieve sustainable revenue growth while reaching adjusted EBITDA profitability in 2025. We also strengthened our cash position with a non-diluted royalty financing agreement. Importantly, given our 2022 ending cash position of 498 million, we do not anticipate the need to raise additional capital to achieve our profitability targets. Both of our business areas achieved significant progress and finished the year strong. In MRD, clonoSEQ clinical volumes grew 51% versus fiscal year 2021 supported by our fully trained sales team, which we nearly doubled during the year. In addition, we launched clonoSEQ and DLBCL and signed an agreement with Epic for EMR integration. Both are key milestones that are fundamental to the growth of our MRD business. In Immune Medicine, we made the strategic decision to focus our commercial and development efforts around pharma services and drug discovery. Pharma services had substantial growth of 67% versus 2021. In drug discovery, our partnership with Genentech had significant progress in both of our cell therapy programs. We are optimistic about the potential of Genentech advancing the first candidate into the clinic. In addition to Genentech, we are focused on leveraging our capabilities to develop our internal programs in autoimmune disorders. We finished the year with a strong fourth quarter of 55.2 million in total revenue representing a significant growth of 46% versus prior year. And our fiscal year 2022 revenue of 185.3 million reflects a 20% growth versus 2021. We're off to a great start in 2023. The momentum is building. We're growing revenue, advancing our pipeline, and we're managing our operating expenses. And importantly, we have the capital to fuel sustainable growth and execute on our long-range plan. I'm going to start with MRD on Slide 4. clonoSEQ is the gold standard for MRD and blood cancers. Over the last decade, we have built strong moats around clonoSEQ that provide significant competitive advantages including best in class sensitivity, broad coverage, clinical evidence, guideline inclusion, and pharma uses of surrogate endpoint in clinical trials. Now, having nearly doubled our sales force expanded into DLBCL, and with the forthcoming Epic integration, it is about execution and driving penetration. As shown in the graph, clonoSEQ test volumes are growing consistently. Fourth quarter volume grew 9% from third quarter to 10,526 tests delivered. Ordering healthcare providers and ordering accounts experienced significant growth of 56% and 47%, respectively, versus prior year, and unique patients tested grew 63%. ASP is nearly $1,100 per test and we expect it to continue to grow annually in the mid-single digit. As we finalize pricing agreements with non-contracted payers and improved collection performance. Our revenue from MRD pharma partnerships, which is a key component of our MRD business is also growing. Quarterly revenue excluding regulatory milestones from these partnerships grew 52% versus prior year and 41% versus prior quarter. This quarter, we recognized a $2 million milestones from the approval of another multiple myeloma therapy, which use our clonoSEQ assay as a secondary endpoint. We are off to a great start this year with clinical clonoSEQ orders at a record high for us in the past month. To further increase clonoSEQ penetration, we are focused on a three-prong strategy shown on Slide 5. First, increased blood-based testing. Blood-based testing will be a catalyst to drive penetration in the community and increase the frequency of testing for patients. clonoSEQ is validated and reimbursed in blood and ALL, multiple myeloma, CLL and diffuse large B cell lymphoma and overall usage of blood in the fourth quarter currently accounts for approximately 1/3rd of all clonoSEQ MRD tests. In addition, as we increase penetration in CLL, and DLBCL, which are primarily blood-based, the overall usage in blood will continue to increase and will catalyze penetration in the community, which now represents 15% of volume versus 12% just last quarter. Second, drive growth in DLBCL. We launched clonoSEQ and DLBCL during the ASH Conference in December. DLBCL represents 30% of patients with non-Hodgkin’s lymphoma and is an aggressive disease with a high relapse rate. We anticipate DLBCL to be a meaningful contributor in the second half of 2023. Expanding access to clonoSEQ allows physicians to detect relapse sooner and create a more precise treatment plan for each patient. We expect to generate additional data in DLBCL and filed with the FDA to support clinical adoption and increased pharma usage. Third, expand clinical used cases by further demonstrating clinical utility at multiple points along the patient care continuum. You can see on Slide 6, a snapshot of the relevance of MRD testing in patients with blood cancers recently featured at ASH more than 30 clonoSEQ-related abstracts and multiple presentations reinforced clonoSEQ's ability to provide valuable insights for treatment surveillance, clinical decision-making, and continued demonstration of the value that clonoSEQ offers to drug developers. A rich set of evidence has driven specific use cases that clinicians are incorporating into clinical practice today. Particularly the master trial demonstrates that 90% of standard risk multiple myeloma patients who have two consecutive MRD negative results with clonoSEQ can stop treatment and remain cancer free after two years. This is an outstanding outcome for patients who can find relief from treatment side effects and also enable substantial savings for the healthcare system. As more studies read out, there will be greater adoption of MRD in the clinic resulting in more patients benefiting from clonoSEQ at multiple time points along the treatment journey. The setup for MRD business is strong, and we are confident that we will achieve significant growth this year. Now, turning to Immune Medicine business on Slide 7. Our Immune Medicine business leverages our platform proprietary ability to sequence, map, and characterize T cell and B cell receptors at scale to drive opportunities in major indications. Growth in Immune Medicine is driven by two main areas, pharma services, and drug discovery. Through pharma services, we deliver rich and valuable immune receptor data to our biopharma customers, that informs biomarkers of response and accelerates their drug development programs. In drug discovery, we are focused on cancer and autoimmune disorders, with the goal to advance therapeutics either on our own or with potential partners. As shown on Slide 8, our strategy and drug discovery is to use our proprietary and differentiated capabilities to discover new drug targets and then develop T cell receptor or antibody therapeutic candidates against those targets. We are already doing this in oncology with our partner Genentech in cell therapy. As shown on Slide 9, we're making good progress with Genentech on two cell therapy programs. For both cell therapy products and development under this collaboration, Adaptive validates specific cancer new antigen targets, and then identifies and characterizes potent therapeutic grade TCRs to those targets. For the first shared TCR candidates selected by Genentech, we are focused on speed to the clinic. In addition, we delivered two additional shared TCR data packages for Genentech's consideration. On the fully personalized program having established our prototype with more than 60 patients, we successfully identified and characterized T cell receptors to patients specific tumor mutations. We also completed end-to-end process runs to start to define early product development. This year, we are focused on standardizing and optimizing our process towards future clinical readiness. In addition to our partner programs, with Genentech in cancer, Slide 10, I liked our internal efforts in autoimmune disorders. In this therapeutic area, disease specific antigens are not well known. We are leveraging our unique capabilities to identify druggable targets in multiple sclerosis, and IBD among others. Next steps are to generate data that validate those targets. So we can make progress towards developing therapeutic assets using our TCR and antibody discovery capabilities. We believe drug discovery is another major value driver in Adaptive and we are excited by the strides we're making with Genentech and our internal programs. I'll now pass it over to Tycho for our financial update.