Chad Robins
Analyst · Piper Sandler
Thanks, Karina. Good afternoon, everybody, and thank you for joining us on our third quarter 2022 earnings call. As always, a big thank you to all our Adaptive employees for their dedication and for delivering another solid quarter. As we approach year-end, we are well positioned to finish strong in both MRD and Immune Medicine. This quarter, as outlined on slide three, we achieved important milestones and results. Starting with key corporate achievements. As planned, we strengthened our cash position to $528 million with an attractive non-dilutive royalty financing agreement with OrbiMed. This agreement extends our cash runway to over three years while providing the flexibility to make strategic investments. We also finalized our long-range plan update, which will enable us to achieve sustainable revenue growth while reaching adjusted EBITDA profitability in 2025 and cash flow breakeven in 2026. Tycho is going to go further in detail during his remarks. Revenue for the third quarter was $47.8 million, representing strong growth of 21% versus prior year. In our MRD business, both our clinical testing and MRD pharma partnerships delivered solid performance. Clinical volumes grew 52% versus prior year and our MRD pharma partnerships also had significant growth of 33%, excluding milestones. Our Immune Medicine business continues to execute on pharma services and drug discovery opportunities. Pharma services drove 23% growth versus prior year as we increased penetration into larger trials. And our Genentech partnership in drug discovery is on track with both our shared and private cell therapy programs. Moving to our MRD business on Slide 4. As shown in the graph, clonoSEQ clinical testing volumes continue to grow quarter-over-quarter. This quarter, tests delivered grew 7% sequentially to 9,650 tests. In the United States, our market of focus, tests delivered grew 11%, with volume growth observed across all 3 marketed indications. Multiple myeloma was the biggest growth driver and the largest contributor to our business. Ordering health care providers and ordering accounts experienced significant growth of 56% and 53% versus prior year, respectively. And unique patients tested grew 62% in the quarter. ASP is now over $1,000 per test and we expect it to grow annually in the mid-single digits as we finalize pricing agreements with non-contracted payers and improve our collection performance. Our strategy to maintain our leadership in MRD testing in lymphoid cancers continues to progress, as shown on Slide 5. First, our expanded sales force is structured into 2 distinct groups, key account managers and diagnostic hematology specialists. These groups serve 2 different customer segments with distinct sales strategies. Key account managers focus on penetrating deeper into our existing established institutions. This quarter, 85% of the growth came from existing institutional accounts, including Mount Sinai, MD Anderson, Dana Farber, Stanford, among others. Our current diagnostic hematology specialist team targets driving adoption and community practice accounts currently representing 12%. Another key driver of growth is blood-based testing, which now accounts for 30% of all clonoSEQ MRD tests. In multiple myeloma, growth in blood was over 100% year-over-year. Blood-based testing is key, and it has the potential to both increase penetration of clonoSEQ among clinicians and the number of tests run per patient. In addition, we are launching a validated diffuse large B-cell lymphoma product at ASH. In line with previous expectations, we anticipate DLBCL to contribute to clonoSEQ growth in the second half of 2023 and beyond. As a reminder, last quarter, we obtained Medicare coverage for all DLBCL patients, 75% of which are Medicare age, regardless of line of therapy, treatment regimen or testing time point. Lastly, we are focused on enhancing the overall customer experience, including more seamless integration of clonoSEQ into clinical workflow. As such, we signed an agreement with Epic to expand access and increase ease of use for clonoSEQ. Shifting to our MRD pharma portfolio on Slide 6. Our clonoSEQ assay is currently being used by over 60 biopharma partners and an over 20% of acted industry-sponsored clinical trials in lymphoid cancers. Almost every major pharma company developing a blood cancer drug is using clonoSEQ in their trials as a secondary or primary clinical endpoint. From these partnerships, besides sequencing revenue, we are also eligible to receive milestones in excess of $370 million based on potential drug approvals from ongoing and future studies. We have line of sight to approximately half of the $370 million in milestones from 74 active trials today, which we anticipate recognizing over the next 5 to 7 years. We believe there is a significant growth opportunity for our MRD pharma business. ClonoSEQ is the gold standard in multi myeloma trials, and we aim to replicate this success in other indications especially in non-Hodgkin's lymphoma where there's significant ongoing drug development activity. Now turning to our Immune Medicine business on Slide 7. Our Immune Medicine business leverages our ability to sequence and characterize T cell and B cell receptors at scale to drive opportunities in various indications. We categorize our immune medicine business into 2 main growth areas: pharma services and drug discovery. Zooming into pharma services on Slide 8. This quarter, pharma services grew 23% year-over-year. This growth is driven by our team executing to incorporate T cell or B-cell receptor sequencing in more and more clinical trials with existing and new bio pharma customers. Our portfolio today consists of more than 140 active studies with more than 85 companies. We expect this double-digit growth to continue in the coming years. Our unique ability to detect and monitor T cell and B cell responses, delivers rich data back to our customers that informs biomarkers of drug response with the ability to accelerate our pharma customers' clinical development programs. As indicated on this slide, we have a diversified portfolio that supports customers in multiple indications. This includes pharma clinical trials in more than 4 major therapeutic areas. Approximately 50% of our current portfolio includes Phase I and Phase II trials. Our growth strategy is to continue to grow in these phases and expand into Phase III programs while bringing on new accounts. Slide 9 shows an overview of our drug discovery business. Drug Discovery leverages our end-to-end TCR and DCR discovery capabilities to develop therapeutic assets either in partnership or potentially on our own. Our partnered pipeline today focuses on our shared and private programs with Genentech to advance cellular therapies in oncology. We are also building an early-stage adaptive pipeline by investing in our core drug discovery competencies that we've built during the last several years. Specifically, the value of our true TCR discovery and our true AB antibody discovery approaches, gives us a unique ability to identify and characterize therapeutic-grade TCRs and antibodies at unprecedented scale. This quarter, drug discovery grew 36% versus prior year due to accelerated amortization of our Genentech upfront. This is due to increased R&D investments and reflects progress on both our shared and private product program [Technical Difficulty] I'm going to pick up at drug discovery. I'm not sure where the phone dropped. This quarter, drug discovery grew 36% versus prior year due to accelerated amortization of our Genentech upfront. This is due to increased R&D investments and reflects progress on both our shared and private product programs with Genentech. In addition to the first neoantigen-specific T cell receptor candidate that Genentech selected this year, we are on track by year-end to complete and deliver to Genentech 2 additional TCR data packages. These 3 TCR assets are the result of our established end-to-end true TCR discovery process that allows us to identify therapeutic grade T cell receptors that are fully characterized and derisked for safety. We are also making excellent progress on our private product program. We have completed initial proof of concept to identify patient-specific T cell receptors for each patient's unique tumor mutations. We are working on product specifications towards early product development with Genentech. The next phase of our personalized prototype is to transition from the research team to the product development team in the coming months while implementing the necessary regulated workflows in our dedicated state-of-the-art South San Francisco lab, we will provide further updates as appropriate. We are excited by our Immune Medicine opportunities from Genentech and future drug discovery programs on the way. I'll now pass it over to Tycho for our financial update.