Adaptive Biotechnologies Corporation

Good day, and thank you for standing by. Welcome to the Adaptive Biotechnologies fourth quarter and full year 2021 earnings results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 1 on your telephone. And if you require any assistance during the call, please press star 0. I would now like to hand the conference over to your speaker today, Ms. Karina Cazadilla, Investor Relations at Adaptive. Ms. Cazadilla, the floor is yours.

Thank you, Chris, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies' fourth quarter and full year 2021 earnings conference call. Earlier today, we issued a press release reporting adaptive financial results for the fourth quarter and full year of 2021. The press release is available at adaptivebiotechnologies.com. We are conducting a live webcast of this call and will be referencing to a slide presentation that has been posted to the investor section in our corporate website. During the call, management will make projections and other forward-looking statements within the meanings of federal security laws regarding future events and the future financial performance of the company. These statements reflect management's current perspective of the business as of today. Actual results may differ materially from today's forward-looking statement, depending on a number of factors which are set forth in our public findings with the SEC and listed in this presentation. In addition, non-GAAP financial measures will be discussed during the call, and a reconciliation from non-GAAP to GAAP metrics can be found in our earnings release. Joining the call today are Chad Robbins, our CEO and co-founder, and Kyle Fiskell, our Intern Chief Financial Officer. In addition, Harlan Robbins, adaptive chief scientific officer and co-founder, and Nathan Soot, our chief commercial officer, will be available for Q&A. With that, I will turn the call over to Chad Robinson. Chad?

Thanks, Karina. Good afternoon, everybody, and thank you for joining us on our fourth quarter and full year 2021 earnings call. As always, I want to thank all of our adaptive employees for their dedication, flexibility, and strong execution during another challenging year. as we continue to adjust to the changing dynamics of the workplace. 2021 was a year of key achievements for Adaptive, which set a solid base for many upcoming catalysts in 2022. Indeed, we are off to a great start with Genentech's selection of our TCR candidate targeting a shared cancer neoantigen to progress as a potential therapeutic product candidate, which I'll discuss later in the call. Before I go into our annual performance details and upcoming milestones, I'd like to address an important initiative we communicated at the J.P. Morgan Conference. As shown on slide three, to effectively allocate capital and drive growth, going forward, we will discuss adaptive around two key and distinct business areas, MRD and immune medicine. The MRD business is comprised of our ClonoSeq diagnostic test offered to clinicians and the ClonoSeq assay offered to our pharma partners to support drug development and approvals. The immune medicine business is comprised of drug discovery, research, and diagnostics driven by our T-cell mapping efforts with Microsoft. This includes Genentech, Nycode, the T-Detect franchise, and ImmunoSeq T-MAP. We aim to begin reporting revenues based on these two business areas by next quarter. Turning to slide four, you can see the significant progress we made throughout the year. Despite the impact from COVID variants, we delivered strong growth and ended the year with $154.3 million in revenue, up 57% versus 2020. Revenue in the fourth quarter grew 26%. In our MRD business, we expanded our Clonaseq sales team, which will be fully trained and in the field by mid-year. And we launched an enhanced version of the Clonaseq assay for CLL patients, which provides additional mutation status information at the time of diagnosis. In addition, multiple clinical studies were published demonstrating clinical utility of Clonaseq for patients. We continue to be the MRD test of choice in pharma clinical trials, having signed two major PAN portfolio agreements in 2021. Regulatory milestones from our partnership started to accelerate with $10 million in recognized revenue during the year. We also achieved important milestones in our immune medicine business. As mentioned on the shared program, Genentech has selected a prioritized TCR candidate to progress as a therapeutic product. Throughout the year, we also made significant progress on the personalized product and successfully completed initial proof of concept in which we identified tumor-specific TCRs using blood from about 60 cancer patients. Another key achievement was the extension of our drug discovery capabilities into vaccines with our NICODE collaboration. This is the first time that our T-cell data will be used to inform the design and development of a T-cell-based vaccine. NICODE has initiated its Phase 1-2 clinical trial for SARS-CoV-2, and we expect data in the first half of this year. Importantly, adaptive technology may inform the design of a new class of T-cell-based vaccines to treat different diseases. We also made great progress in our T-DETECT franchise, highlighted by the emergency use authorization of T-DETECT COVID. This is the first T-cell-based test authorized by the FDA and clearly marks an important strategic milestone for T-DETECT. We also completed the ImmuneSense Lyme study, which is the first clinical validation study successfully conducted by Adaptive. We expect to enable T-Detect Lyme in our CLIA lab offering during Lyme season and to leverage our consumer pay experience that we learned from T-Detect COVID. In autoimmune disorders, we identified four signals demonstrating the applicability of our technology in this hard-to-diagnose class of diseases. Lastly, I'd like to touch on the important traction of our TMAP COVID product. which is being used by multiple pharma partners such as J&J, AstraZeneca, and Moderna to understand the T cell response to COVID vaccines. This is just the beginning of our ability to leverage mapping data as a product for pharma to understand the immune response across diseases. Now I'm going to provide more details on our business starting with MRD on slide five. There is a strong synergy between clinical adoption and inclusion of ClonoSeq in pharma drug development trials. The integration of ClonoSeq in pharma trials increases the value of MRD for clinicians to make therapy decisions and raises awareness of ClonoSeq validation and sensitivity. At the same time, the adoption of ClonoSeq in clinical practice drives its inclusion as an endpoint in pharma clinical trials. Both clinical testing and pharma partnerships achieved significant growth and traction during 2021. For the full year, tests delivered grew 48% to 22,516 tests. Ordering healthcare providers and ordering accounts experienced significant growth of 57% and 32% respectively versus 2020. And approximately 28% of all tests were done in the blood. During the last few weeks of December, we experienced a slowdown with intersection of the Omicron surge and the holidays. However, we have seen an uptake in January and anticipate that our commercial investments, data readouts, and expansion of our commercial offering will enable us to overcome last year's headwinds such that we accelerate our growth trajectory in 2022. We began expanding the sales team with a focus of reaching the community settings. Our goal is to have a sales team fully built out and trained by mid-year, which will allow us to deepen our penetration in academic centers and increase our reach into the community. As part of our growth strategy to increase blood-based testing and expand indications, we are seeking Medicare coverage for diffuse large B-cell lymphoma. It is important to note that Clonacy for multiple myeloma and NHL in blood are already available through our CLIA offering. On the pharma side, our Clonacigase is currently being used in 155 active trials by more than 60 pharma companies. Importantly, we're embedded across all phases of the clinical development and used as a clinical endpoint across multiple indications with different drug modalities. Through these partnerships, in addition to the per sample sequencing revenue, we also have access to more than $330 million in regulatory milestones. Now, let's turn to the immune medicine business on slide six. We have been building the necessary capabilities to identify and map T cell receptors to disease-specific antigens that serve as a source code for T-DETECT, pharma partnerships, and our drug discovery efforts. We validated this platform strategy with our COVID efforts and are now organizing our teams to repeat the success in other infectious diseases and in autoimmune disorders. Slide 7 shows the most advanced indications for T-DETECT, their progress, and next steps. During 2021, over 30,000 consumers ordered a T-DETECT COVID test. For the most part, orders followed the course of the pandemic. with significant increases during variant surges. We will continue to offer the test to consumers with modest promotional activities to maintain awareness and monitor demand behaviors as the pandemic evolves. To increase the value proposition in a potential endemic state, we're working with vaccine manufacturers to generate correlate of protection data and other measures of efficacy. We're in direct communication with the FDA to determine the best path forward and we will continue to provide updates as the data progresses. 2021 was a year of signal generation in the autoimmune space for T-DETECT. We first confirmed a T-cell signal specific to ileochrones and demonstrated T-cells were distinct from those that recognize colitis. This data is being presented at the European Crohn's and Colitis Organization Scientific Conference this week. We also completed the analysis of over 5,000 IBD samples, which supported encouraging signal identification in colonic Crohn's and colitis. In addition to IBD, we confirmed a signal in multiple sclerosis and have identified an early signal in rheumatoid arthritis. It's important to understand that our TCR classifiers get more sensitive as the sample size increases. Our focus this year is to improve these autoimmune signals by significantly increasing sensitivity while maintaining extremely high specificity in order that we minimize false positives. To that end, we're in the final stages of designing our protocol to initiate clinical validation in IBD. We believe autoimmune disorders represent a large market opportunity for differentiated clinical diagnostics. and a meaningful opportunity to inform drug development with our pharma partners. Lastly, slide eight shows progress in our cell therapy collaboration with Genentech. We continue to make good progress with both our shared and private programs. Regarding our shared program, we delivered efficacy and safety data for a TCR candidate that targets a shared cancer neoantigen. Following review of data generated by both Adaptive and Genentech using this TCR candidate, Genentech recently selected this neoantigen-specific TCR. Also, this year we're on track to deliver to Genentech up to two additional TCR data packages. In our private program, following successful initial proof-of-concept screens, this year we aim to centralize, test, and optimize the personalized process using additional cancer patient samples in our purpose-built South San Francisco lab. We continue to work closely with Genentech to establish the private product specifications and build our private product data package. The personalized data that we generate this year with Genentech will define early product development. I'll now pass it over to Kyle Pitskill for our financial update.

Thanks, Chad. I'll first review our fourth quarter financial results, briefly describe our full year financial performance, and then we'll provide an outlook for 2022. Turning to slide nine, total revenue in the fourth quarter was $37.9 million, representing a 26% increase from $30.2 million in the same period last year. Our revenue mix for the fourth quarter consisted of 61% of our revenues coming from sequencing and 39% coming from development. Sequencing revenue in the fourth quarter was 23.1 million, an increase of 81% for the same period in 2020. Growth in sequencing revenue was driven primarily by a 6.5 million increase in revenue generated from our pharma customers and a 3.3 million increase in revenue generated from our clinical customers. Research sequencing volume increased to 9,510 sequences delivered up 61% from 5,907 sequences delivered in the fourth quarter of 2020. Clinical sequencing volume, excluding T-DETECT COVID, increased 41% to 6,356 clinical tests delivered in the fourth quarter of 2021 versus prior. Development revenue was $14.9 million in the fourth quarter, down 15% for the same period last year due to lower amortization of the Genentech upfront payments. Shifting now to our operating costs. Total operating expenses for the fourth quarter of 2021 were 99.5 million, representing a 34% increase from 74.4 million in the same quarter last year. Cost of revenue was 14.4 million during the fourth quarter of 2021, compared to 6.2 million for the fourth quarter last year, representing a 131% increase. Higher cost of revenue was primarily driven by an increase in material costs due to volume growth and an increase in labor and overhead expenses. Research and development expenses for the fourth quarter of 2021 were $34.7 million, compared to $35.8 million in the fourth quarter of 2020, representing a 3% decrease. This decrease was mainly attributed to lower material costs and production volume partially offset by increased personnel costs. Sales and marketing expenses for the fourth quarter of 2021 were $26.7 million, compared to $18.5 million in the fourth quarter of 2020, representing an increase of 44%. This growth was primarily driven by an expansion of the KonoSeq organization and commercial support. General and administrative expenses for the fourth quarter of 2021 were $23.3 million, compared to $13.4 million in the fourth quarter of 2020, representing an increase of 74%. The increase was primarily driven by an expansion of our overall facility footprint and higher depreciation expenses, as well as growth in headcount, personnel costs, and consultant expenses. Net loss for the fourth quarter of 2021 was $61.4 million compared to fourth quarter 2020 net loss of $44.6 million. Adjusted EBITDA for the fourth quarter of 2021 was $44.9 million compared to a loss of $34.6 million in the same period last year. Quickly, turning now to our annual financial results for 2021, total revenue was 154.3 million, representing a 57% increase from 98.4 million in 2020. Our revenue mix consisted of 51% of our revenues coming from sequencing and 49% from development. Sequencing revenue in 2021 was 78.9 million, an increase of 90% from 2020. Research sequencing volume increased by 42% to 32,146 sequences delivered versus 2020. Clinical sequencing volume, excluding T-detect COVID, increased by 48% to 22,516 clinical tests delivered compared to prior year. Development revenue grew to $75.4 million in 2021, up 32% from last year. The increase was largely due to growth in revenue generated from our Genentech collaboration and a $7.5 million increase in revenue recognized from milestones related to our MRD pharma partners. Operating expenses for the year totaled $363.3 million, representing a 45% increase from $251.2 million in 2020. The largest driver of OPEX growth on an absolute dollar basis was sales and marketing, which grew by $34.1 million. up 56% from prior year. This was mainly due to additional personnel costs. We also saw increased investments made in ClonoSeq and T2Tech marketing efforts. Full year 2021 net loss was $207.3 million compared to $146.2 million in the prior year. Adjusted EBITDA for 2021 was a loss of $151.7 compared to a loss of $119.6 million in 2020. We ended the year with approximately $570 million in cash, cash equivalents, and marketable securities, and we have no debt. With respect to our outlook for 2022 on slide 10, we expect full-year revenue to be in the range of $185 to $195 million. At the midpoint of the range, we anticipate our sequencing and development mix to be approximately $60-$40 million. This would represent growth in the mid-40% range for sequencing revenues versus prior year and roughly flat year-over-year for development revenues. Our development revenues largely comprised of the amortization of the $300 million upfront from our Genentech partnership, which we expect at similar levels to 2021. It also includes potential milestones in the low to mid-teens millions that are available to us this year from our various pharma partners. With respect to trends over the year, we expect Q1 to be the low watermark. This is mainly due to normal seasonality coupled with an Omicron overhang from Q4 and no anticipated milestones during the quarter. In addition, the growth in our sequencing business is expected to be back half-weighted as our expanded Clonaseq sales force hits its stride around mid-year. Regarding our operating expenses, we expect full-year OpEx growth to be in the mid to high single-digit range from our fourth quarter 2021 run rate level. This deceleration in spend reflects the significant investments we made last year, which will continue to support our core growth initiatives as we continue to ramp the business. We are being thoughtful about our cash and expect to deploy capital off our balance sheet to support those projects with the greatest potential while consistently growing revenues faster than expenses. With that, I'll hand it back over to Chad.

Thanks, Kyle. As you heard during the call and shown on slide 11, 2022 is expected to be a catalyst-filled year with multiple shots at goal across both our MRD and immune medicine businesses. We're off to a running start, and I'm confident in the success of our business as we continue to execute and demonstrate the capabilities of our platform. With that, I'd like to turn the call back over to the operator and open up for questions.

Thank you. As a reminder, to ask a question, you'll need to press star one on your telephone. To withdraw your question, please press the pound key. Stand by as we compile the Q&A roster. Our first question comes from Mark Massaro of BTIG. Your line is open.

Hey, guys. Thank you for the questions. I guess maybe the first one on the 2022 revenue guide You know, at the midpoint, it came in about $3 million below consensus, I guess. We understand that, you know, sequencing revenue is going to be about 60% of the total revenue for the year. Can you just give us, you know, Chad, you know, your comments suggest that, like, access to the clinic seems to have improved in January. So can you just give us maybe some framework for what led you to this guidance recognizing that hopefully, you know, maybe we're out of the woods with COVID perhaps. But can you just give us some of the puts and takes to how you came up with that range?

Yeah, sure. Hey, Mark. So, first of all, it's early in the year, and we want to be prudent. But there's variability in revenues associated with the milestones, and there's some variability in some of the T-detect with the changing dynamics of the pandemic. There also is potential upside in some of the T-cell mapping efforts and potential target discovery efforts that we're looking from our T-cell franchise. and there could be a potential upside in Clonacy, both in the clinical business and the MRD pharma business as well. But we're very confident in our ability to execute, and like I said, it's early, and we want to make sure that we're being prudent as we look forward to the year.

Maybe just my second question. You know, you did get attractive reimbursement for T-Detect COVID. What are you seeing with respect to demand there? I think you talked about ebbs and flows related to variants, but do you see that being a material product here in 2022? And how should we think about that test sort of, you know, being any type of read-through to any other products in your franchise?

Yeah, that's a really good question. I mean, it's First and foremost, I think it was great that we were acknowledged by CMS for this important use case in COVID. We are currently enabling the software infrastructure for the reimbursed product. It is important to note, though, that the new rate hasn't started yet. We're assessing our path forward in light of really the changing nature of the pandemic. As I mentioned on the comments related to guidance, This isn't a very significant portion of the revenue profile of the year, and we're being extremely prudent in monitoring what's going on in the pandemic. As far as a read-through, remember the COVID test is an EUA. and it gave us a lot of experience in launching a test to consumers. We're going to leverage some of that consumer-related experience, but for the future tests, the test case for kind of Lyman going forward and setting us up for the franchise and the launch of the IBD panel in 2023, What we're looking to do is really get that whole machinery and infrastructure in place, and we're building that out, you know, over the course of the year so that we can rapidly deploy tests up on the system in a clean environment to generate data and to be able to launch tests with an extremely high specificity and increasing sensitivity that have a high, you know, positive predictive value to patients.

Sorry, just a quick follow-up to the guidance question. I know you talked about how Q1 will be the low watermark for the year, but in Q1 of 2021, you did grow sequentially. So can you just help us determine whether or not you expect to grow sequentially at Q1 2022? Yeah, I mean, this is Kyle.

Q1 2021 was a little bit of a difficult comp for us. We had, you know, 7 million in milestones recognized during that year and also a little bit of pull-through, which we typically see at the end of the year from our pharma business in Q1 2021. So, you know, while Q1 of 2022 is kind of sequentially stable to Q4 of 2021, we're still expecting to see modest growth in the sequencing line and roughly flat again on the development line with no milestones anticipated.

Okay. That's it for me. Thanks, guys.

Thanks, Mark. Thank you. Our next question comes from Brian Weinstein of William Blair. Your line is open.

Hey, guys. How are you doing? Thanks for taking the questions. So obviously you talked about the MRD and the immune medicine kind of characterization, but is that mostly an external reporting mechanism, or can you just talk about how the business is being structured internally, if there's been any changes in terms of how you're structuring it along these lines and if it's changing kind of the way that you're thinking about investments here, or is this strictly just an external kind of reporting mechanism?

Thanks, Brian, for the question. Actually, it's both external and internal. You know, what we're trying to do in terms of providing clarity externally, at the same time we're trying to create very focused teams around the different business areas for businesses that really fit together. And so if you think about it, MRD Pharma and Clonaseq really fit together And at the same time, all of the underlying mapping data that supports all of the opportunities in immune medicine under really kind of that T cell franchise all fit together. And so we're not only looking to align our revenues to these business areas, we're also looking to align organizationally so that we can better prosecute and be focused and nimble against these opportunities.

Great. And then as a follow-up, on the MRD, the $330 million, obviously you guys aren't going to talk about who the partners are. You said that I think you had 60 or so of them, but can you just give us an idea about kind of the sizes that some of these potentially could be and the timing that some of the more important ones might read out? I recognize that you're risk-adjusting things in your guidance, but Is there any kind of additional light that you can shed on kind of the makeup of that $330 million at this point?

Yeah, this is Kyle again. I'd say think of the basket of milestones, the $330 as being one-third relating to secondary endpoints and two-thirds of them relating to primary endpoints. We've got access to the secondary endpoints right now, and that's what you're seeing run through today. in our top line numbers and expect us to continue to see that this year and on to the next year. And then once our pharma partners get access to enabling these as primary endpoints, you know, we expect to see the rest of that two-thirds kind of unlock and start to fall into our top line.

Okay. I guess I'll just leave it there. Thanks so much, guys. Thanks, Brian.

Thank you. And next we have Derek DeBrun of Bank of America. Your line is open. Hi. Good afternoon.

Hey, Derek. So, hey, a few questions. So what's embedded in your guide for clinical testing volumes? You know, last year at this time you talked about doubling clinical volumes. In 21, obviously, the pandemic sort of stymied those plans, but – I'd love to know sort of what you're embedding in the guide for volume.

Yeah, so, you know, this is Nitin. I'll take that question. So, despite COVID, you know, we had strong growth in 2021. We grew 48%. Our HCPs that ordering the test grew 57%. And as a result, you know, we've So we decided to expand our sales team because all the leading indicators for the business are very positive. Good news is we've completed the hiring and we're deploying the expanded sales team where we've doubled the size of the sales team. And 2022 is off to a good start. We actually had a very strong performance in January. So I'm confident of our strong position, the momentum we're seeing, and I expect that our growth trajectory will actually increase in 2022. And we also have a lot of other things outside in the industry that are acting as catalysts. For example, in CLL, we're seeing the adoption, a greater adoption of fixed duration therapy. These therapies require measurement of depth of response. And obviously, you know, MRD is the choice to do so. In multiple myeloma, we're seeing clinical data reading out right now that allows MRD-directed de-escalation of therapy. That's another catalyst. And then finally, in non-Hodgkin's lymphoma, Medicare is providing a path for reimbursement, which I think will be a longer-term catalyst. So overall, I expect 2022 to grow stronger than 2021. And we actually expect, given our penetration, to have growth in, you know, even beyond 2022 into 2023 and 2024.

Right, yeah. But ultimately, I mean, when you report next quarter, are you going to give us a volume number? Because ultimately that's one of the metrics the street is going to look at.

Yes, we will give volume numbers. Yeah, and Derek, as part of that breakup of the businesses, That is one of the things that will be an output of that is that we'll be able to provide volume numbers around the business.

Got it. And are you going to – does anything change historically just from sort of how we should think about thinking about the volumes between the clinical and the pharma business?

No, I wouldn't think anything historically would change. You're just going to get an additional dimension to look at MRD and aggregate across our clonacy business and our pharma business. Got it.

So why, you know, the gross margin has been down quite a bit the last couple of quarters. I mean, does that expect to sort of like creep back up, or does it stay sort of like pressured to these levels in the 60s?

I mean, some of that's a reflection of the milestone timing. And I'd say expect, you know, to see modest improvement, especially as we're accessing more of our MRD pharma revenues, which have higher ASP price points over the year. So I wouldn't expect big swings over the periods outside of when we see milestone revenues land in the P&L.

Got it. I noticed on your catalyst chart there wasn't anything called out for LIME. What's the pathway on that in 2022?

Yeah, for T2Tech LIME, remember just to frame this, this has been a great technical proof point of a platform, and while it does have a minimal revenue contribution in 2022, it's really key to building the foundation for of our CLIA-related infrastructure to be able to enable one blood test for multiple answers. So not only are we building a lab, we're building all the software and data infrastructure to be able to essentially launch test after test through the exact same system. And so what we're doing is learning how to update and improve the classifier as we continue to generate more data disease by disease. So we are going to launch in Lyme, and this is gonna be a patient-directed physician-ordered consumer test to begin with, and then we're gonna aggregate that data and increase sensitivity over time. We'll launch first in the acute setting, but the goal here is to get into the larger segment of the post-treatment Lyme disease setting, which then enables us to access a larger testing population. So we're still kind of finalizing the pricing and kind of moving forward under that premise.

Great. And it's one more if I can. So how do we monitor, you know, from the Genentech standpoint on, you know, obviously the candidate was selected, you know, maybe that was a little bit more, the news around that was a little bit more muted than we had anticipated. I thought, you know, there might have been a little bit more information on that. How should we sort of think about you know, the candidate selection and some of the other packages and just how do we sort of monitor the progress of this? It's like what's the, you know, what are the obligations, if any, from Genentech to sort of disclose?

Yeah, so just to frame it, so Genentech selected the TCR candidates to move forward. It's against a neoantigen, which is expressed in tumors and not on healthy tissues, so there's inherently a better safety profile associated with that type of antigen. So Genentech will determine kind of the timing to advance its first cell candidate forward into the clinic with certain goals in mind. So they're going to have to demonstrate the kind of manufacturability of the product, and they also have kind of further work to do in terms of ensuring safety and administration to the patient population. So we're working kind of closely together to do more of that kind of end-to-end testing. And then further this year, we have – You know, we have a whole library of candidates, and we're going to aim to submit an additional kind of two data packages to generate this year. We can't disclose, you know, the targets. But we could – there is a potential that we could have several stacked milestones over the next few years kind of associated with the product – sorry, with the program, I should say. Okay. Great. Thank you.

Thank you. And next we have Tejas Savant of Morgan Stanley. Your line is open.

Hi, this is Yuko on for Tejas. Thank you for taking our questions. With investments behind a Clonoseq sales force, would you elaborate on the magnitude in which the increased sales force would expand on your existing call points, or is it more that there will be increase in the frequency of calling on those positions?

Yes, so as I said, we are doubling the size of our sales team. We'll have around 70 or so individuals doing two things. One is deepening our penetration in the existing accounts we have, primarily in the academic setting. So there they'll be increasing the frequency with which they call out to physicians. and expand the number of physicians that reach out into those accounts. And then the second part of the sales team is going to be focused on adding new accounts, primarily in the community setting. So we'll be doing both activities, deepening the penetration of the accounts we already have, and then adding new accounts in the community setting.

Thank you. That was super helpful. And then one more. Regarding the NHL opportunity for ClonoSeq, Would you comment on the current practice regarding minimal residual disease monitoring and DLBCL? Is this a market that you expect would likely need to invest in to build awareness?

Yes. So in terms of the use of MRD in non-Hodgkin's lymphoma or in DLBCL, this is certainly behind myeloma and CLL, but the adoption or the clinical need is increasing, as evidenced by the fact that Medicare provided a path for reimbursement. However, a lot more clinical evidence needs to be generated to drive adoption, and we will be investing in clinical studies to demonstrate the use of MRD in the LBCL.

Got it. Thank you.

Thanks, Chico.

Thank you. Next we have Tico Peterson of JPMorgan. Your line is open.

Hi, this is Rachel. I'm for Tycho. Thanks for taking the question. So first up on T-DETECT, can you just share your latest development progress with Crohn's and celiacs? So what are the latest milestones that we should watch for? And then what is the timeline for launching T-DETECT GI syndromic panel?

Yeah. Hey, Rachel. Thanks for the question. Yeah. So again, what we're focused is really on... launching a test with a very high positive predictive value, which means that we have to set the specificity very, very high and then increase the sensitivity over time. So for IBD, which is the farthest advanced, we are planning on launching a test next year to a set of patients with shared symptoms. We completed, so far, 5,000 IBD samples and confirmed in ileochromes and have signals in colonichromes and ulcerative colitis. So we're looking at a specificity in the 99.5% range and then improving the sensitivity all through this year is really the goal is to increase those metrics. And we are launching a clinical validation study that we're preparing for. We're going to be launching that this year and preparing for a launch in 2023. So we're looking at a kind of two- to four-year diagnostic path for patients, four to five kind of specialist visits and thousands of dollars for these patients to get diagnosed. And we're really looking to essentially eliminate or significantly reduce that diagnostic odyssey kind of by launching this path forward in IBD.

Great. And then it's good to hear about the decision to go forward with the TCR candidate with Genentech. But to clarify, can you just say, are you guys progressing to IND ready for that candidate or not?

Can you repeat that last part?

Yeah, if you guys are progressing to the investigational new drug application for the TCR candidate with Genentech.

There's a lot of steps as we prepare to have a successful clinical trial, but certainly that's the direction we're all moving in. Yeah.

Sounds good. And then last one from me. Just on Clonacy, can you give us an update on how your conversations have been going with private payers? And then does guidance assume any additional traction with private payers this year?

Yeah, so I think, as you know, you know, we have about 240 million covered lives, you know, for multiple myeloma and for ALL. You know, in terms of increasing coverage, we're very heavily focused on CLL, where we have about 150 million covered lives. Further, you know, we are engaged in conversations with private payers to really improve, you the collection rate we have, and our focus is going to be to, you know, drive increase in ASP. So expectation is mid-single digit increase in overall ASP in 2022. Great.

Thank you.

Thank you. And again, to ask a question, You need to press star 1 on your telephone. To withdraw your question, please press the pound key. Our next question comes from Salveen Richter of Goldman Sachs. Your line is open.

Great. Good afternoon. Thank you for taking our question. This is Elizabeth on for Salveen. Just regarding the guidance to deliver the two additional TCR data packages by year end for the shared program. Yes, could you just comment on the key learnings ahead of this, given the first candidate was selected to move forward, and then just your general thoughts on how, you know, the program may be a little bit de-risked at this point and just how you're thinking of this as a de-risking event.

Sure, Ms. Harlan, I'll take that. So for the – both with this So for now, we're staying away from naturally occurring targets in the human genome so that we're de-risking the safety profile, and that will continue for our other targets as well, the two other data packets that we're going to deliver. I know we don't get to communicate that much, but the team's been working really hard behind the scenes, and we've generated a very large number of T cell receptors against a wide variety of targets and have been working hand-in-hand with Genentech. So we've learned quite a bit about what's acceptable to them and also what we find acceptable to move forward and think has the best chance of really being able to patients with cancer. So I'd say the program is certainly de-risking as we go, as we improve our technology and learn more. Hello? I think we lost you.

Thank you. Yeah, that was our question.

Oh, great. Thank you.

Thank you. And speakers, I see no further questions in the queue. I return the conference back to you for closing remarks.

Thank you very much. We look forward to a great year.

This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.