Adaptive Biotechnologies Corporation

Q3 2022 Earnings Conference Call

11/3/2022

speaker
Operator
Good day, and thank you for standing by. Welcome to the Adaptive Biotechnology's third quarter financial 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 the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would like to now hand the conference over to your speaker today, Karina Calzadilla, Vice President, Investor Relations. Please go ahead.
speaker
Karina Calzadilla
Thank you, Talisha, and good afternoon, everyone. I would like to welcome you to Adaptive Oil Technologies' third quarter 2022 earnings conference call. Earlier today, we issued a press release reporting adaptive financial reports for the third quarter of 2022. The press release is available at www.adaptivebiotech.com. We are conducting a live broadcast 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 meaning 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 statements, 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 Tycho Peterson, our Chief Financial Officer. In addition, Arlen Robbins, adaptive chief scientific officer and co-founder, Nathan Sood, head of MRG business, and Sharon Benzino, head of immune medicine business, will be available for Q&A. With that, I'll turn it over to Chad.
speaker
Talisha
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 in 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 OrbaMed. 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. Taika 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 Clonacy 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 four. As shown in the graph, Clonacy clinical testing volumes continue to grow quarter over quarter. This quarter, test delivered grew 7% sequentially to 9,650 tests. In the United States, our market of focus, test delivered grew 11% with volume growth observed across all three marketed indications. Multiple myeloma was the biggest growth driver and the largest contributor to our business. Ordering healthcare 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 five. First, our expanded sales force is structured into two distinct groups. Key account managers and diagnostic hematology specialists. These groups serve two different customer segments with distinct sales strategies. Key account managers focus on penetrating deeper into our existing established institution. 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 clonal-seq 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 CLIO-validated strep tube-based 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-aged, 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 Clonaseq. Shifting to our MRD Pharma portfolio on slide six, our Clonaseq assay is currently being used by over 60 biopharma partners and in over 20% of active 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 five to seven years. We believe there is a significant growth opportunity for our MRD pharma business. Clonoseq is the gold standard in multiple 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 seven. 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 two main growth areas, pharma services and drug discovery. Zooming in to pharma services on slide eight. 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 biopharma 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 four major therapeutic areas. Approximately 50% of our current portfolio includes phase one and phase two trials. Our growth strategy is to continue to grow in these phases and expand into phase three programs while bringing on new accounts. Slide nine shows an overview of our drug discovery business. Drug discovery leverages our end-to-end TCR and VCR 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 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 . You're on live, Jeff. Okay. 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 two additional TCR data packages. These three 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 de-risked 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.
speaker
Karina
Thanks, Chad. Turning to our financial results, starting with revenue on slide 10. Total revenue in the third quarter was $47.8 million, with 58% from immune medicine and 42% from MRD, representing a 21% increase from the same period last year. MRD revenue of $20 million, good 26% from a year ago, with clonal-seq clinical testing and MRD pharma partnerships driving approximately 51% and 33% of the growth, respectively. This growth was partially offset by a $1.5 million decrease in MRD regulatory milestones. While we continue to anticipate milestones from our MRD partnerships, these are not within our control and will vary quarter over quarter. Clonal-seq test volume, including international, increased 52%, to 9,649 tests from 6,341 in the same period last year. We expect strong growth to continue through year end. Immune medicine revenue was 27.9 million, up 18% from a year ago. This change was driven by a $5.4 million increase from Genentech and a $1.3 million increase from pharma and academic, partially offset by a $2.5 million decrease from T-Detect COVID. Shifting to operating costs and guidance on slide 11, total operating expenses were 93.3 million, representing a 3% decrease from 95.8 million last year and a 3% decrease versus the prior quarter. Cost of revenue was 14.9 million compared to 14.2 million last year, representing a 5% increase, primarily driven by increased labor and overhead costs, partially offset by a decrease in material costs due to lower sample volumes. R&D expenses were $35.7 million compared to $36.1 million a year ago, representing a 1% decrease, mainly due to decreased investments in T-Detect. This was partially offset by higher drug discovery expenditures related to Genentech. Sales and marketing expenses were $21.5 million compared to $24.9 million a year ago, representing a 14% decrease, largely due to our ongoing efforts to drive operating leverage. General administrative expenses were $20.8 million compared to $20.2 million a year ago, representing an increase of 3%. This was partially driven by higher personnel costs as well as building facility and depreciation. Lastly, interest expense from a royalty financing agreement with OrbitMed was $700,000. Net loss for the quarter was $45.3 million compared to $56 million last year. Now turning to full year guidance, we are narrowing our revenue range to 185 to 190 million from 185 to 195 million. We now expect the contribution from our businesses to be approximately 47% from MRD and 53% from immune medicine at the midpoint versus 50-50 as previously anticipated. The change of guidance is a response to a shift in timing related to our anticipated MRD pharma milestones. For operating expenses, we now expect the full year to be below 400 million compared to our prior expectations of $410 to $415 million. This reflects our ongoing efforts to drive efficiencies from a number of areas. We expect our quarterly burn rate in the fourth quarter to be below $50 million and aim to further reduce it next year. Our capital position is strong, and we ended the quarter with roughly $528 million in cash and equivalents, including $125 million from our deal with OrbitMed. Slide 12 shows more details related to the OrbitMed agreement. As Chad mentioned, we are pleased to have entered into a non-dilutive royalty financing agreement with OrbitMed, a leading healthcare investor, for up to $250 million. This additional cash adds to our already strong balance sheet and provides us with flexibility to support our growth profile while reaching profitability. Turning to long-term guidance on slide 13, following our restructuring around two business areas, MRD and immune medicine, We have worked extensively on our latest long-range plan to ensure that we are allocating capital prudently and investing behind the projects to support our growth profile with higher returns. As you can see from the slide, we estimate revenues to grow at a 20% to 30% CAGR through 2027, while our operating expenses are expected to grow at a much lower pace, leading to positive adjusted EBITDA in 2025. In addition, this operating model gives us the ability to reach cash flow breakeven in 2026. Importantly, given our strong cash position, we do not anticipate the need to raise additional capital to achieve these profitability targets. Our performance is solid and our outlook is strong, so we believe we are well-positioned to deliver sustainable growth with a clear path to profitability. With that, I'll hand it back over to Chad.
speaker
Talisha
Hey, thanks, Tycho. As outlined today, we're delivering on our promises. Both our immune medicine and MRD businesses have great momentum to achieve the respective catalysts listed on slide 14, and we have a strong balance sheet to support future growth. I'd like to turn it back over to the operator and open up for questions.
speaker
Operator
Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster. The first question comes from the line of David Westenberg of Piper Sandberg.
speaker
David Westenberg
Hey, hi. Thank you for taking the questions here. So I'm going to start here with the DBCL adoption ramp. So what are we thinking about for DBCL adoption ramp, given the fact that, you know, I think Klonospeak, and sorry if you disagree with this characterization, you did really, really well. Pandemic hit. It kind of slowed. You know, you had really good momentum in 2022. You know, I think you have had a little bit of critical mass, particularly in the first half of this year with the Colonial Seek business. Do you think that you can ride that momentum in DBCL and this is going to be faster than, say, the ramp that you got in multiple myeloma and I believe the first one was ALL, right? Okay. Hey, David, it's...
speaker
Talisha
Hey, David, it's Chad. I'll make one comment, then I'll pass it over to Nitin to specifically address DLBCL. We are very still low penetrated in our marketed indications in myeloma, ALL, and CLL. So I think there's a significant ramp of our existing indications. And with the new launch of DLBCL, again, I'll hand it over to Nitin to specifically comment on timing and ramp.
speaker
David
Yeah, and I just want to build on what Chad said, you know, multiple myeloma, which is a key growth driver for us going forward, grew 17% quarter over quarter this quarter. So, you know, we're still at sort of 6.5%, 7% penetration in multiple myeloma. So there's a lot of room for multiple myeloma to drive growth going forward into 2023. Talking specifically about DLBCL, At ASH this year in December, we will launch the DLBCL strecQ-based clear validated assay. We expect this assay to contribute to growth in the second half of 2023 as it takes time for us to educate physicians on the use of blood-based MRD testing. You know, the current standard of care in DLBCL is imaging-based monitoring. We have data to show that DLBCL has higher specificity than imaging and detects recurrence earlier than imaging. you know, the foundation and the fundamentals are strong. You know, as we continue to do physician education, I think the second half of 2023 is where we'll see the growth of the LBCL.
speaker
David Westenberg
Got it. Maybe I might ask a continuation with that. I mean, I believe, you know, your physicians are pretty educated in the fact that, you know, this is counting T cells and B cells, and really, theoretically, this could be used on any kind of T cell or B cell mediated cancer. So can I ask, you know, how much of this, how many of this is actually already being ordered off label? And, you know, it would just be, you know, as you get Medicare coverage, maybe some turning on of some additional ASP and, you know, maybe I'm completely off base with that question. Yeah.
speaker
David
You know, around sort of 10% of our ordering volume is outside our main indications. You know, this includes DLDCL. This includes, you know, CTCL, MCL, and other indications. So, you know, we'll see, obviously, you know, we'll get paid on the DLBCL component of that test. But I think as we expand into the community, which is where DLBCL is treated, we'll see a greater uptake of DLBCL. In addition, you know, we will continue to file for reimbursement for these other indications like NCLCTCL, and that will contribute overall to increasing our ESP as well.
speaker
Talisha
Got it. David, it's also... I was just going to make another comment. It's also worth noting, if you look at the number of trials right now going on in non-Hodgkin's lymphoma, particularly in DLVCL, the necessity to monitor residual disease as these new therapies hit the market really do drive clinical adoption and awareness. That's why the MRD clinical business and the MRD pharma business are incredibly synergistic, as we've seen kind of in multiple myeloma. That's what you'll start to see, again, being conservative in the second half of 2023. Got it. Thank you.
speaker
David Westenberg
And if I'm not being too greedy here, I'm just going to squeeze one more in for Tycho here. You mentioned additional cost cuts into 2023. Is this going to be primarily in R&D or SG&A? And You know, in terms of, I know you've done a lot of restructuring in the immune medicine business, particularly around, specifically around T-Detect. Is there some remaining stuff there, or has that already been, or have those costs been mostly removed? Thank you.
speaker
Karina
Yeah, the costs for P2Tech specifically are kind of out of the equation when we made that decision last quarter. I think, you know, to give you some high-level commentary on 23 without getting too quantitative guidance, which we'll give on the fourth quarter, you know, I'd say we're looking at a lot of things. I mean, publicly we've talked about real estate consolidation. We've talked about workflow enhancements, leveraging sequencing costs. Obviously, Illumina is driving down costs there. There's some stuff in the cloud compute costs. But, you know, the other angle here is, yeah, as we went through our long-range planning process, you know, we came up with a list of R&D projects and triaged them and, you know, mapped them to revenue and margin. And, yeah, there are some opportunities to drive a little bit of R&D leverage. G&A will have some leverage as well. And we'll communicate more, you know, as we give official guidance. But it's all part of a process of getting more efficient, you know, as a company and being more thoughtful about how we invest our dollars.
speaker
Chad
I appreciate it. Thank you, guys.
speaker
Operator
The next question comes from Tejas Savant of Morgan Stanley. Please go ahead.
speaker
Tejas Savant
Hey, good morning, guys. This is Edmond . Just wanted to touch bases on your partnership with Epic. I was wondering how you envisioned the integration of their integration into their EMR system will impact volumes once it goes live in 23. Sure.
speaker
Talisha
Nitin, I'll let you cover that as well.
speaker
David
Yes. So we've initiated work with Epic and expect to have accounts up and running in 2023. We've started with four pilot accounts and expect that integration to be completed within six months. And, you know, overall, we're anticipating the impact on order volumes in the second half of 2023 and a more considerable, much bigger impact in 2024. And the way we think about this is, you know, first, Epic will We'll sort of standardize the use of QuonoSeq in accounts that we already have, so sort of drive deeper penetration in the accounts that we have, and then reduce the barrier for adoption in the newer accounts. So, overall, we're pretty excited about this. We're underway, and, you know, we expect to announce more updates on this in 2023. Got it.
speaker
Tejas Savant
And then peers in the space have talked about hospital staffing issues, and you've also noted seeing order spikes in the past. I was wondering if this trend has changed over the past few months, and separately on the biopharma side, some peers have also noticed clinical child sample collection and deliveries being slowed down due to staffing shortages. Are you seeing similar trends here?
speaker
Talisha
Go ahead, Ninh.
speaker
David
Yeah. Yeah, I mean, I think, you know, I would say we're not seeing sort of any significant, you know, impact. You know, we see sort of variability here and there related to various events, but I would say both, you know, our pharma business as well as our clinical business looks, you know, looks, you know, off to a good start in Q4. And, you know, I'm, you know, we were pretty feeling pretty good that we continue to grow robustly about 50% in 2023.
speaker
Chad
Great, thank you.
speaker
Operator
Our next call comes from Julia Chen of JPMorgan Chase. Please go ahead.
speaker
Julia Chen
Hello, thank you for taking the question. This is Martha for Julia. So I want to take a deep breath into the 2023 I know it's a bit too early, but can you share some qualitative color regarding upcoming headwinds and tailwinds, any type of indicators or factors you could share with us without giving the specific numbers? Thank you.
speaker
Karina
Yeah, I don't think we want to say a lot about 2023 until we're ready to officially guide. I did mention in my prepared comments we're going to continue to drive operating leverage, so that's an ongoing focus, and we laid out our path to profitability, obviously, on the call today. You know, I don't know. I mean, you just touched on the hospital end market. I mean, is there anything else you would add in terms of end market dynamics for MRD that you want to flag? Yeah.
speaker
David
Yeah, I mean, I think, you know, I'd just like to, again, sort of highlight the fact that all the leading indicators are looking strong. You know, the number of HCPs in accounts grew 50% year over year in this quarter and has been in the last few quarters. The number of unique patients tested grew 60%. You know, so, and that combined with the fact that our penetration both in the pharma space as well as in the clinical diagnostic space is low, you know, I think we feel, you know, that we'll do pretty nicely in 2023, and all the leading indicators look positive, and we'll provide specific guidance, as Taiko said, in Q4.
speaker
Talisha
And Sharon, can you make a couple comments on our immune medicine business, particularly Genentech?
speaker
John
Absolutely. With Genentech, again, we're making great progress on both fronts, both the shared and the private product. And as Chad mentioned, significant growth in terms of what we achieved in Q3 and look to do the same closing out this year into next year. As it relates to the new medicine pharma services, similarly, we expect good growth trajectory as well in 2023 and beyond. with significant opportunities to penetrate in later stage clinical trials and across multiple indications relevant to our athletes.
speaker
Karina
One thing I'll add just from the financial perspective, again, we're going to wait to officially guide with the fourth quarter call, but we will take a more conservative view around the MRD pharma milestones. You saw that in the narrowing of the range for the fourth quarter. Those can move around quarter to quarter, of course, and I think as we go forward, we're going to try to kind of de-risk the reliance on those. So that's one area I'll flag ahead of official guidance where we'll be a little bit more conservative.
speaker
Chad
That's very helpful. Thank you. Another question is in Go ahead. Sorry, was there an additional question? Operator, do you want to go to the next one?
speaker
Operator
Sure. The next question comes from the line of Derek DeBrine from Bank of America.
speaker
Chad
Please go ahead. You can go to the next one.
speaker
Operator
Okay.
speaker
Chad
Operator, if you want to go to the next question, it would be great.
speaker
Talisha
Thank you.
speaker
Operator
Sure. The next question comes from the line of Salveen Richter of Goldman Sachs. Please go ahead.
speaker
Elizabeth
Hey, guys, this is Elizabeth on Perselvy, and thanks for taking our question. I had a question on the drug discovery efforts and specifically the antibody therapeutics area. What are adaptive key differentiators, and can you speak to the status of those discovery efforts currently? Thank you.
speaker
Talisha
Sure. Sharon, you want to take that?
speaker
John
Absolutely. Hi, Elizabeth. So similar to our TTR discovery efforts with Genentech and what attracted Genentech, amongst many of our capabilities is the sheer scale at which we discover and are able to characterize naturally occurring potent T cell receptors. The same applies for antibody discovery where the technologies and the platform that we've built and validated for the past several years allow us to identify those ultra unique antibodies which you alluded to. We have a portfolio of potent neutralizing antibodies They happen to be against SARS-CoV-2. And we're pursuing additional capabilities to be able to focus on areas that really differentiate us against targets that we may discover in areas that are unmet need, like autoimmune disorders.
speaker
Elizabeth
Got it. And when can we expect the next catalyst or milestone from that program?
speaker
Chad
So our strategy is to monetize on our existing assets.
speaker
John
As I mentioned, neutralizing antibodies, because of the portfolio of antibodies we've identified, we have several of them that are still relevant, given some of the variants that exist today. So our core strategy is partnering for both, but in the interim is really heads down on elaborating, as Chad mentioned, our own potential pipeline where antibody discovery can really make a unique differentiator for advancing those assets either in partnership or perhaps in the future on our own.
speaker
Chad
Got it. Thanks for the color.
speaker
Operator
Our next question comes from Derek. Debrine from Bank of America, please go ahead.
speaker
spk08
Hi, good afternoon. This is John on for Derek. Can you hear me?
speaker
Talisha
Yeah, we can hear you.
speaker
spk08
All right, yeah, apologies. I was double muted. Forgot to mute the other one. In terms of any commercial benefit down the road from your work on PTLDS, is there sort of a timeframe on when you might decide that data might become positive? And along with that, thank you for the five-year long-term plan. Just wondering, like looking at your profitability target by 25 and the cash flow positivity by 26, you're obviously looking to spend less and burn less cash, but if you could just provide any puts and takes there. And if I could just squeeze in one more there. If you're In that same long-term range, I was wondering what sort of contribution you're assuming from like the perhaps like future target discovery in therapeutics or, for instance, how much contribution you might be assuming from like COVID in, to detect COVID in Lyme, given that you talked about how the financial contributions should be minimal in the coming quarters. Apologies for lumping them all in.
speaker
Talisha
Sure. Yeah, no, thanks, John, a lot there. Sharon, I'll have you cover the post-treatment Lyme disease syndrome, and then Tycho, I'll have you cover some of the puts and takes on future cash flow and then how we're moving, kind of bringing in profitability years, and then I'll make some overall comments on strategic direction. So you want to start?
speaker
John
Absolutely. So in Lyme CCLDS, because of the investment we previously had made, we are wrapping up the last time point of the cohort that we enrolled, and that completes sort of an assessment in different settings of individuals with Lyme. The goal there in the strategy, as overarchingly for CEATx, is opportunities that we may have with our pharma partners. As you may know, there are a number of therapeutics out there now, both the vaccine but other modalities, and so we're going to be opportunistic to leverage that data, including in the PTLDS setting.
speaker
Karina
On the long-term guidance, you know, as we kind of laid out on the slide there, it's a 20% to 30% revenue CAGR. The goal is to, you know, try to drive OpEx leverage. You know, over the long-term plan, you know, we do expect low single-digit OpEx growth over that same period. You know, one nuance, the difference, you know, on EBITDA positivity in 2025 is that we're excluding stock comp and then cash flow break even in 26. You know, the cash flow components, you know, include the royalty payments to OrbitMed and obviously working capital. I don't know that we're going to give a lot more color on kind of what's behind the revenue projections. We certainly don't want to get into kind of, you know, talking about specific partners or deals in the long-range plan. So I think that's all we'll kind of say at this point.
speaker
Talisha
Yeah, and I'll just make a comment with respect to our immune medicine business and our strategy, which is we built a unique set of capabilities over the last several years to identify targets and then find immune receptors, both T cells and antibodies against those targets. And what we're doing kind of from an investment standpoint is prioritizing opportunities to either ourselves or in partnerships to kind of leverage those capabilities moving more into the therapeutic area. So that's what I'll say about that for now. Obviously Genentech is the first set of catalysts, but behind that we're working on quite a few things that kind of leverage those capabilities.
speaker
Karina
And just to round it out, you know, the long-term guidance does not assume revenues from T-DETECT. You know, we kind of made that decision last quarter to pause and online in particular, so there's really nothing in the long-term outlook for T-DETECT on the diagnostic side.
speaker
spk08
Gotcha. Thank you for that. And if I could ask on the DLV-BCL as well, you're obviously trying to increase you're trying to educate the physicians here and you're having conversations with the pharma sponsors, the clinical trial sponsors. Any update on the physician access, for better or for worse, or has it held steady? And if there are any additional channels you're finding helpful in getting in front of them, what sort of work are you doing?
speaker
Talisha
Nitin, you want to take that?
speaker
David
Yeah, I mean, if I understand the question correctly, you know, physician access in general is improving and, you know, has improved quite a bit. It's also region dependent. Certain regions, you know, it's, you know, full-on in-person meetings. In other regions, you know, physicians have, you know, just sort of permanently shifted over to meeting virtually, you know, and But I think overall, you know, we're just driving growth in multiple ways. You know, I think Epic integration is going to help a lot. Expanding into DLTCL and in the community is going to help a lot. So I think there's a lot of catalysts for growth going forward.
speaker
Chad
Appreciate the color. Thank you.
speaker
Operator
Last call for questions. As a reminder, if you'd like to participate in the Q&A, please press star 1-1 on your telephone and wait to be announced.
speaker
Chad
Okay. If that is all, thank you for your participation in today's call.
speaker
Operator
This does conclude the program. You may now just thank you for your
Disclaimer

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