NASDAQ:ADPT Adaptive Biotechnologies Q1 2024 Earnings Report $7.77 -0.13 (-1.65%) Closing price 04/28/2025 04:00 PM EasternExtended Trading$7.97 +0.20 (+2.63%) As of 04:24 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Adaptive Biotechnologies EPS ResultsActual EPS-$0.33Consensus EPS -$0.35Beat/MissBeat by +$0.02One Year Ago EPS-$0.40Adaptive Biotechnologies Revenue ResultsActual Revenue$41.87 millionExpected Revenue$38.78 millionBeat/MissBeat by +$3.09 millionYoY Revenue Growth+11.20%Adaptive Biotechnologies Announcement DetailsQuarterQ1 2024Date5/7/2024TimeAfter Market ClosesConference Call DateTuesday, May 7, 2024Conference Call Time4:30PM ETUpcoming EarningsAdaptive Biotechnologies' Q1 2025 earnings is scheduled for Thursday, May 1, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Adaptive Biotechnologies Q1 2024 Earnings Call TranscriptProvided by QuartrMay 7, 2024 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to the Adaptive Biotechnologies First Quarter 2024 Earnings Call. Please note, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. Operator00:00:27I would now like to hand the conference over to your first speaker today, Corina Calandia, Head of Investor Relations. Please go ahead. Speaker 100:00:37Thank you, Corey, and good afternoon, everyone. Speaker 200:00:40I would like to welcome you to Adaptive Biotechnologies' Q1 2024 earnings conference call. Earlier today, we issued a press release reporting Adaptive financial results for the Q1 of 2024. The press release is available on www.adaptivebiotech.com. We are conducting a live webcast of this call and will be referencing to a slide presentation that has been posted to the Investors section in our corporate website. During the call, management will make projections and other looking forward statements within the meaning of federal securities laws regarding future events and future financial performance of the company. Speaker 200:01:17These 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 filings with the SEC and listed in this presentation. In addition, non GAAP financial measures will be discussed during the call and will be reconciled in non GAAP to GAAP metrics that can be found in the earnings release. Joining the call today are Chad Robbins, our CEO and Co Founder and Kyle Pindzko, our Chief Financial Officer. Additional members from management will be available for Q and A. Speaker 200:01:53With that, I'll turn the call over to Chad Rollins. Chad? Speaker 300:01:57Thanks, Karina. Good afternoon, and thank you for joining us on our Q1 earnings call. As communicated last month and shown on Slide 3, moving forward, both our MRD and Immune Medicine businesses will remain under the adaptive umbrella, each with its own dedicated resources and separate segment reporting. This will provide each business with the autonomy to execute on the respective focused strategies, which are for MRD, marching towards profitability with a strengthened financial profile and for immune medicine, translating science in cancer and autoimmunity into breakthrough therapeutic programs with clear guardrails to guide investment. Importantly, we continue to preserve our strong capital position with approximately $309,000,000 as of March 31, which enables us to bridge the R and D business to profitability and to support targeted investments in immune medicine. Speaker 300:02:58Our position is further strengthened by access to additional non dilutive capital through our agreement with Orbit. Now let's take a closer look at the MRD business on Slide 4. The MRD business had an impressive quarter with $32,600,000 in revenue representing 52% growth versus prior year driven by both clinical and pharma. On the clinical side, volumes continue to grow quarter over quarter with over 17,000 tests delivered in Q1, representing a 41% increase prior year and a 9% increase sequentially. Growth came from all marketed indications and multiple myeloma continues to be the largest contributor, representing approximately 40% of volume. Speaker 300:03:45The diffuse large B cell lymphoma is our fastest growing indication, growing approximately 25% quarter over quarter and now contributing to 5% of total tests. We also continue to be laser focused on driving ASP growth by reducing auto policy and non contracted claims and improving revenue cycle management. Importantly, we are encouraged to see the recent preliminary GAAP bill rate of set by Medicare of $18.23 per test, an increase from our current implied per test rate under the episode structure. Once finalized, this rate would go into effect beginning of 2025. This rate, which will have implications for both Medicare and commercial payer pricing, give us further confidence in our ability to grow ASP per test by $200 over the next 2 years. Speaker 300:04:41In addition, clonoC key indicators continue to trend positive in Q1. Blood based testing represented nearly 40% of tests with multiple myeloma in blood now at 20% following positive data presented at ASH in December. Tests in the community continue to grow sequentially, contributing about 25% of tests delivered. Ordering HCPs and ordering accounts grew 33% 25% versus prior year respectively. Additionally, EMR integration remains central to our efforts to further enhance our customer experience and to solidify our market leadership position. Speaker 300:05:20We saw post integration quarter over quarter growth of 40% across the first four accounts we integrated at the end of 2023 and we now have 9 additional active Epic integrations in motion. Looking at MRD Pharma on Slide 5. Our pharma business started the year strong with Q1 revenue growth of 71% versus prior year. Sequencing revenue grew 17% and we recognized milestones from 2 drug approvals. Last month, the FDA's Oncologic Drug Advisory Committee or ODAC voted unanimously in favor of the use of MRD as a primary endpoint to support the accelerated approval of new therapies for patients with most myeloma. Speaker 300:06:02ODAC's recommendation, if accepted by the FDA, has potential to accelerate myeloma patient access to novel therapies and to reduce drug development costs. In addition to clonaseq being the only FDA cleared MRD assay for patients with multiple myeloma, and it's also the singular assay that can consistently deliver the sensitivity and standardization needed to meet the FDA performance standards. This further solidifies clonosate as the assay of choice for multiple myeloma drug developers. So what does this mean for clonosate? On the revenue recognition front, we can potentially accelerate the realization of revenue from existing studies. Speaker 300:06:42There's also potential to generate new bookings as companies reprioritize their multiple myeloma programs to leverage a faster path to commercialization. On the milestone recognition front, we also have the opportunity to monetize our portfolio primary endpoints from existing MRD Pharma contracts. In addition, this could represent a positive halo effect for the continued acceptance of MRD as a standard measure of response in the clinic. Now let's turn to immune medicine on Slide 6. The I'm business is focused on developing differentiated immune driven therapeutics in cancer and autoimmunity. Speaker 300:07:24In oncology, we continue to support and work closely with our Genentech colleagues in the development of TCR based cell therapy products targeting tumor neoantigens. We're jointly working with Genentech on a holistic review of the programs to enable the development and delivery of the highest impact therapy for patients. Both companies are excited and committed as we move forward with these developments. We'll provide you with an update at the appropriate time. In autoimmunity, we narrowed our focus to select indications in multiple sclerosis and type 1 diabetes, where we believe there is still a high unmet need to develop better, more targeted therapies with a better side effect profile. Speaker 300:08:05Our approach allows us to discover the specific T cells that are attacking itself. Therapeutically, our goal is to eliminate or block the activation of these problem T cells and directly stop them from attacking healthy tissue. In MS and T1D, we've successfully identified the subset of auto reactive T cell receptors that are likely causing these devastating diseases. And in multiple sclerosis, we've confirmed the specific self antigen or target to which these T cell receptors bind. This quarter, we started our antibody discovery campaigns in MS and T1D. Speaker 300:08:41Our goal in 2024 is to discover, make and test select antibodies to generate preclinical data that informs further investment by year end. We continue to gauge our R and D investments based on expected data readouts throughout the year. In Q1, we aligned our resources to execute on these select 2024 programs and specific goals. As a result of these changes, we expect to reduce our immune medicine operating expenses in 2024 by more than 50% versus prior year. The I'm business remains disciplined on its spend and we continue to engage with strategic partners to help offset our cash burn. Speaker 300:09:20Now I'm going to pass it over to Kyle to go through the key financials and provide detail on segment reporting. Kyle? Thanks, Chad. Speaker 400:09:28Let's start with revenue for the Q1 on the left of Slide 7. Total revenue in the Q1 was $41,900,000 with 78% from MRD and 22% from immune medicine. MRD revenue grew to $32,600,000 up 52% from a year ago with clinical testing and MRD Pharma partnerships each driving approximately 48% 12% of the growth respectively, along with a 4,500,000 increase in regulatory milestones. Excluding these milestones, MRD revenue grew 31% from a year ago. Immunomedicine revenue was $9,200,000 down 43% from a year ago, driven largely as expected by lower Genentech amortization, which decreased 49% as well as decreases in I'm pharma services due to a shift in focus towards target and drug discovery efforts. Speaker 400:10:23Moving down the P and L, total operating expenses including cost of revenue were $90,600,000 representing a 4% decrease from last year. This decrease was mainly driven by the continued emphasis on driving leverage across functions and reductions in research and development expenses as we continue to prioritize our investments in Innovate Medicine. Cost of revenue decreased 3%, resulting in gross margin for the quarter of 57 percent, a 7 percentage point increase versus a year ago. This increase was mainly attributed to MRD milestone recognition, partially offset by lower amortization of Genentech upfront. Finally, interest expense from our royalty financing agreement with Orban was $3,000,000 which was more than offset by interest income. Speaker 400:11:10Net loss for the quarter was $47,500,000 compared to $57,700,000 last year, while adjusted EBITDA was a loss of $28,200,000 compared to $37,100,000 in Q1 of 2023. Now turning to segment reporting on the right side of the slide. Restructuring activities during the quarter aligned resources and operations, sales and marketing and R and D towards either the MRD or immune medicine businesses. These resources and related costs are dedicated to each business and are included within the operating spend of MRD and immune medicine respectively. Other corporate functions such as finance, legal, HR and IT continue to be managed centrally to avoid dis synergies from duplication. Speaker 400:11:52We allocate the majority of these corporate expenses to each segment using direct headcount in MRD and immune medicine, which is approximately 75% MRD and approximately 25% I'm Certain expenses will remain unallocated such as our corporate insurance costs, governance, audit fees, our idle facility and interest income and expense, which are reflected under an unallocated corporate segment. In addition to operating expenses per segment, we are also providing adjusted EBITDA, which adjusting for certain income and expense line items can be used as a proxy for cash burn per segment, excluding CapEx and working capital. Now turning to our updated full year guidance on Slide 8. We are updating our MRD full year revenue guidance to $135,000,000 to 140,000,000 dollars bringing up the midpoint of the range to reflect the realization of milestones not previously included in the guidance. With respect to trends throughout the year, we continue to expect MRD revenue to be about 45%, 55% weighted between the first and second half respectively. Speaker 400:12:59For the year, we are lowering the total company estimated operating spend to $350,000,000 to 3.60 dollars a $10,000,000 reduction from our previous guidance as we continue to drive leverage across the businesses and manage investments. Of this total spend approximately 70% sits within the MRD business and approximately 25% within immune medicine. We continue to be thoughtful about our cash position. Excluding one time costs from restructuring activity, we now expect the burn to average approximately $30,000,000 for the remaining three quarters, which implies an annual cash burn of $130,000,000 versus our previous estimate of $140,000,000 dollars This represents a 14% reduction in cash burn over full year 2023. Of note, approximately 50% of the cash burn this year is expected to come from the MRD business and approximately 40% from the immune metal business. Speaker 400:13:52The remaining 10% is due to the unallocated corporate costs. I look forward to providing you with further financial updates throughout the year as we continue to make progress towards our goals. With that, I'll hand it back over to Chad. Speaker 300:14:05Thanks, Kyle. As I think it's evident, we've made important decisions over the last couple of months. I'm confident we're taking the right steps as we move forward with our 2 business segments and execute on the priorities. Our cash position is strong and we're disciplined in managing our capital to bridge the MRD business to profitability, while supporting measured investments in immune medicine to advance our key programs. With that, I'll turn the call back over to the operator and open it up for questions. Speaker 300:14:32Thank you. Operator00:14:34Thank you. At this time, we will conduct a question and answer session. Our first call comes from the line of Mark Massaro from BTIG. Mark, your line is open. Speaker 500:15:00Hey, guys. Congrats on the quarter. Thank you for taking the question. I recognize it's only been about 3 or 4 weeks, but following the FDA ADCOM meeting or ODAC meeting, where multiple myeloma was recommended to be a unanimous primary endpoint in clinical trials for multiple myeloma. Can you just give us a sense for what you've been hearing in the marketplace? Speaker 500:15:28Any of your customers perhaps looking to pick things up a little bit on the clinical trial side? And how do you envision this impacting your business like over the next couple of years? Speaker 300:15:41Yes. Thanks, Mark, for joining the call. I'm going to pass it over to Susan, who can provide quite a bit of color on that. Susan? Speaker 100:15:49Thanks, Chad, and thanks, Mark. Yes, I mean, the ODAC vote, we think it's a huge milestone for the field of myeloma and obviously tremendous news for patients. We have been in active discussions with our pharma partners to discuss potential implications. And while many companies are waiting for the final FDA guidance, which we do expect to be shortly forthcoming, we already have a few studies that have been upgraded primary endpoint as well as a few new studies where MRD is being used a few new studies where MRD is going to be used as a primary endpoint directly as a result of the ODAC vote. In general, as Chad outlined, we see some potential upside in a couple of areas. Speaker 100:16:28First of all, acceleration of primary endpoint milestones that have already been established in ongoing studies. Additionally, upgrading, as I mentioned, of trials that are currently secondary endpoint to primary endpoint status, which will both accelerate the realization of those milestones and also increase their value. And then potentially additional new bookings as pharma companies reprioritize their development programs to center more on back end myeloma. In the clinic, we've also had an opportunity to have quite a few conversations around this topic and clinicians are universally very, very excited on behalf of their patients. They see a tremendous remaining unmet need. Speaker 100:17:09And they also acknowledge the strength that this recommendation coming directly from MODAC and ultimately likely from FDA, provides to the credibility of MRD as a measure of clinical response and as a tool they can use in dialogue with their patients to individualize their care. We really do believe that there is potential for a halo effect, in the clinic as well. Speaker 500:17:35Okay. That's great. And then, it was nice to see the MolDX gap fill rate of 18.23 per test. I think that is scheduled to go live, I think January 2025. How are you thinking about commercial payers? Speaker 500:17:52Is that something that you can potentially initiate that dialogue ahead of the go live date with MolDX? How should we think about that as an incremental driver to the business? Speaker 100:18:05Yes, absolutely, Mark. So you're correct that it will go live formally on January 1 after it's finalized later this year. We are already leveraging the published preliminary rate in conversations with commercial payers. So there are 2 implications in the short term. We have several large non contracted payers who have been holding out waiting for the PLA price to be published so that they could complete their negotiations on price with us. Speaker 100:18:32And so we've already engaged them to advance those negotiations and of those of note and some is a particularly large one that we're working with utilizing the recently published price. Additionally, over time, we can use this price to re approach existing contracted payers to potentially bring up contracted rates that we've previously negotiated if they are below the PLA price. Speaker 300:19:00And one other comment, Mark, worth noting, this as we've mentioned a couple of times, the preliminary pricing rate, obviously, no there's no promise when we continue to work with MolDX on kind of finalizing the price and the episode structure. Speaker 500:19:19That's great. And then one last one for me. You took up the low end of the guide for MRD. I assume that's just cycling in the $4,500,000 milestone that you realized in Q1. Just clarifying that and then how should we think about the total contribution in MRD milestones for the full year? Speaker 400:19:43Yes, Mark, this is Kyle. Yes, the B and the low end pull is fully related to the milestones. As it relates to the go forward, I'd say we continue to be conservative as we think about the milestones in our guidance. We're not necessarily anticipating anything. We don't control the timing and we'll see how it plays out throughout the rest of the year. Speaker 400:20:06It's still early. Speaker 500:20:08Okay. Thanks guys. Speaker 400:20:10Thanks Mark. Operator00:20:12Thank you very much. One moment while we gather our next question. Our next question comes from the line of David Westenberg of Piper Sandler. David, your line is open. Speaker 600:20:24Hi, thank you for taking the question and congrats on all the progress here. I mean, that's a really nice update. The $18.23 it is higher than I remember. I think it was $6,870 for 4. So it was like $1700 a test, which is about a little over $100 Now you said you think that you can have this be $200 so can you run us through the math that gets $200 versus the other difference there? Speaker 600:20:53Also, I just wanted to have a clarification because the last payment was for 4 tests at that 6,000 $870,000,000 rate. With this new rate, does that imply that it's kind of no open end, I mean no closed end after that 4th pass? And I have just one more question. Thank you. Speaker 300:21:13Yes. Maybe I'll start and Susan, please if you want to add color, you can afterwards. Remember, the $200 in ASP raised over the next 2 years is a combination of multiple factors. We talked about reducing out of policy claims and non contracting claims and we're doing a lot of work operationally on revenue cycle management, faster collections, We're actually implementing AI and the appeals process. There's a whole bunch of things that we're doing just to collect money faster. Speaker 300:21:49So as Susan just mentioned, having the new kind of gap fill per price test will also allow us to kind of use that dollar amount to go and close some of those kind of non contracted claims gap that will further enhance it. But if you look at kind of the Medicare percentage of tests, this was this is, I would say, I'm going to call it right now a de risking event to allow us to get to the $200 but it wasn't necessarily contemplated kind of originally in that $200 So I want to be careful, but could represent some potential upside. But certainly, at least all we're looking at right now at least de risking and we're quite confident that we're going to be able to get that $200 increase over the next 2 year period. The second I wasn't sure I totally understood your second question, David, if you could maybe ask it again. Speaker 600:22:45Yes. If I'm not mistaken, your original rate, it was 6,870 for 4 tests. And I wasn't sure after the 4th, like the 5th test, did you get 1750? I don't remember if you actually did. I kind of remember you didn't, but I could be wrong. Speaker 600:23:02I mean, my memory is failing from time to time. So I was thinking if there's any update in terms of being able to get paid in perpetuity versus if there's like a fixed number, rate number of tests. Speaker 300:23:16Yes. So, okay. A couple of comments here, David. On the Medicare episode structure, we don't get paid yet for what we'll call recurrence monitoring. That being said, we have a submission in right now in our first indication for mantle cell lymphoma that we have nice data on our first kind of recurrence monitoring tests that could essentially once a patient goes into remission kind of sets a new bar on a per test rate for Medicare. Speaker 300:23:47Separately, on commercial payers, we don't have a limitation a per case basis, so we can get paid in perpetuity for as many tests as deemed medically necessary. Speaker 600:23:59Got it. Okay. Thank you very much. And just as my follow-up, is there I'm just one of the ODAC meeting, another really positive development here. Is there differences in behavior in the way MRD is used in clinical trials in pharma versus how it's used in clinical? Speaker 600:24:18And specifically, I'm kind of thinking about things like testing interval or testing in terms of timing and when the test is done. And the reason why I'm asking you this question is, does this have a chance to change behavior in the clinic in terms of maybe test frequency and use cases following greater usage in clinical trial and after I'm done after that? Speaker 200:24:46Sure. No, thanks David for the question. Speaker 100:24:48I mean certainly we see that there are synergies in both directions between the MRD pharma and clinical use cases. And depending on the setting in which the trial is being performed, depending on the type of patients who are eligible for the study, the time points and frequency of testing can vary and may also vary in the clinic for those exact same reasons. So while there are no definitive differences that I would call out between clinical and pharma based use of the test, certainly the use is customized to the particular need of the investigator or the clinician and patient. One thing though that I would call out is that in the clinic, blood based testing has begun to really take shape, with about 20% of our MRD test now coming from blood and myeloma. That's something that pharmas have great interest in, but we have not yet really explored in-depth. Speaker 100:25:41And I certainly think that with the incorporation of MRD as an endpoint myeloma, there will be quite a few additional opportunities that will open up, exploration of deeper sensitivity testing in pharma studies as well as potentially use of blood down the road. Speaker 600:25:57Got it. Thank you. And I forgot to give Kyle a congrats on the new position. Thank you. Speaker 400:26:03Appreciate it. Thanks, David. Operator00:26:05Thank you very much. One moment for our next question. Our next question comes from the line of Tom Stevens of TD Cowen. Tom, your line is open. Speaker 400:26:17Hey, guys. Thanks for taking the question here. Speaker 700:26:20Just one on kind of the EBITDA margins by segment and thank you for breaking that out. I guess it looks like today it's kind of negative 50 from about 100 last year and it looks like quite a big lift on an incremental basis to get to breakeven by back half as kind of guided. Clearly, there's a lot of tailwinds there. There's the pricing tailwinds. There's the switch to the X. Speaker 700:26:43But I guess, could you break out maybe in a more granular way for investors just how you get to that breakeven by next year? Speaker 400:26:53Yes. I mean, I'll talk, I mean broadly, obviously the ASP initiatives are a big factor, margin improvements to reduce our kind of per volume test costs. And really the biggest driver is the leverage throughout our operating expenses both on the sales team and those margin profiles at the end Speaker 300:27:16of the day as we continue Speaker 400:27:17to grow ASPs and the pharma business. Speaker 300:27:20Yes. I mean, Tom, it's 3 things, right? It's raising the price per test, it's lowering the cost that we deliver each test and it's continued to look at kind of operating expenses, and we're doing all 3. And you can see that we've made improvements and kind of reduced the operating expense for the year of $10,000,000 We continue to look at ways that we can kind of reduce expenses and gain leverage and we will do so. Speaker 400:27:50Great. And Speaker 700:27:52then yes, go on, sorry. Speaker 400:27:53Just to reiterate, back half of twenty twenty five adjusted EBITDA breakeven and then the cash flow is not till 26. So just to make sure that we're clear on that. Speaker 700:28:03Yes, definitely. And then just a question on kind of blood, you kind of mentioned it's now 20% of your multiple myeloma volumes. What reimbursement rate are you getting on blood versus your kind of more traditional bone marrow or spinal tap? Speaker 100:28:21Our reimbursement rates aren't distinguished by sample type. So, our coverage policy, both for Medicare and for majority of private payers are sample agnostic. So coverage applies both to bone marrow and to blood based testing for myeloma. Operator00:28:46Our next question comes from Sung Ji Nam of Scotiabank. Sung, your line is open. Speaker 800:28:53Hey, this is Corey Rosenbaum on for Sung Ji. Thanks for taking my questions. So with the recent FDA ODAC recommendation, during the meeting, there a big discussion around the 10 to the minus 6 sensitivity threshold. Are any of the existing trials using climacy currently differentiating between 10 to the minus 5 and 10 to the minus 6? Just wondering how the industry may be able to start evaluating the differences between these two sensitivity thresholds? Speaker 800:29:18Thanks. Speaker 100:29:20Yes. Thanks for the question, Cory. Absolutely, a number increasingly studies are being designed to differentiate between 10 to the 5th and 10 to the 6 sensitivity and of course, clonoSeq is really the singular assay that can deliver that level of sensitivity consistently with a reasonable sample input and with the standardization across patients. So what we are actually hearing from the investigators who were central to the preparations and the data that went into support for the ODAC meeting couple of weeks ago, they acknowledged that most of the data historically that was able to be analyzed was at negative 5th. But the group, the KOLs have moved on to 10 of the 6th as the real important standard threshold And they are already anticipating pursuing additional engagements with the FDA over the coming months years to move that threshold to 106 over time. Speaker 800:30:22Awesome. Thank you. That's all for me. I'll hop back to the queue. Operator00:30:26Thank you very much. One moment for our next question, please. Our next question comes from the line of Tejas Savant of Morgan Stanley. Tejas, your line is open. Speaker 900:30:39Hello, this is Yigal on for Tejas. Thank you for taking our questions. Where are you in the restructuring and resource allocation process, the increased independence between the two reporting segments today? Are there any work that remains to be done heading into the back half or are they in good place operationally? Speaker 400:30:57I'd say the 90% of the work has been done. In Q1, we realigned the workforce and most of that was aligning operations and R and D investments around each of the businesses. That work is complete. We still have a little bit of transitory processes in extracting the immune medicine pharma services lab from our production lab for the MRD business, but that's the only kind of remaining activity. So by and large, everything is done and we're operating in that vein today. Speaker 900:31:31Great. And then asking a question on the ODAC meeting. Following the AdCom, how do you see FDA receptibility to discussing MRD as an endpoint in other Are there particular features of trials that may not read through to other heme indications like ALL, CLL or DLBCL? Speaker 100:31:56Yes. Thank you for the question. In fact, that's Speaker 200:31:59a question that was of Speaker 100:32:00great interest to us as well. And certainly, we do anticipate that this FDA likely FDA decision following the ODAC vote will pave the way for further discussion with the FDA about MRD as an endpoint and other indication. The one that investigators have expressed most interest to us about is CLL. And that is one for which currently the thresholds that are utilizing guidelines and in many trials are 104. But just like in myeloma, there's interest in continuing to move that threshold further to the benefit of patients. Speaker 100:32:35And so we're already actively engaging with investigators to talk about how we might potentially support those efforts, providing data, and supporting studies that are already being designed. We've also had conversations with our pharma partners. And interestingly, many of those who we've talked to with the intent of focusing on myeloma are actually taking a bigger picture view and looking across their portfolios to think about how they might proactively leverage MRD more prospectively in anticipation of the FDA essentially being more open to MRD data across hematologic malignancies in the forthcoming time. Speaker 900:33:16Great. Thank you very much. Operator00:33:19Thank you very much. One moment for our next question. Our next question comes from Andrew Brackmann of William Blair. Andrew, your line is open. Speaker 1000:33:33Hi, everyone. This is Maggie Bui on for Andrew today. I wanted to ask one on the progress of the EMR integration. I know you spoke to earlier some strong growth in the quarter from customers, but just wanted to know like what feedback has been for the accounts that you've recently added? And then how many more accounts do Speaker 200:33:51you expect to be able Speaker 1000:33:52to add this year? And then how is this factoring into growth assumptions? Speaker 100:33:57Yes. Thank you for the questions, Maggie. We are hearing very positive feedback. As you might imagine, it makes the assay significantly easier to use both from an ordering perspective and in terms of integrating the results directly into the patient's chart for clinical use. We have 9 active projects that Chad mentioned currently in motion with IT departments at the specific sites. Speaker 100:34:24We have dozens of additional sites that are in conversations, securing IT resources, going through various approval processes, and we are ready to go with any account that's ready to move. I'll note that some of the accounts that are in active IT development are among our largest accounts. And in fact, 15 of our 20 largest accounts are Epic customers. So we're very eager to move those forward and to ensure that a meaningful portion of our volume goes through Epic over the next 1 to 2 years. We do anticipate by the end of this year, continue to expect between 2025 accounts to be integrated. Speaker 100:35:06That will represent somewhere between 15% 20 percent of our volume we expect. And we expect to continue to increase the speed whereby we can get these accounts up and running. Our most recent projects are trending toward about a 7 week timeline, which is really nicely aligned with industry standards for integration. Speaker 1000:35:28Great. Thank you so much. And then I wanted to ask another one on improving gross margins just as I know that's one of the drivers to reach your profitability targets for MRD. Can you talk about the progress of some of the initiatives there such as the transition to NovaSeq and the LEMS overhaul and how these are progressing? How should we be thinking about these driving improvements in gross margins over time? Speaker 1000:35:50Thank you. Speaker 400:35:52Yes. I mean, I think 1st and foremost on the gross margins ASP initiatives, we're starting to see kind of some of that pull through with strong collections subsequent to the quarter. As it relates to the costing profile of the assay with the transition in OOC, in OCC. I think of that as a 25% of that. We're still undergoing the development aspects of that and assessing that. Speaker 400:36:14So I view that as 25%. And then I think the other thing to just note is overall as a company, we're going to continue to look at everything we can do to streamline operations and continue to gain leverage without increasing expenses to get to that profitability metric. So I think of leveraging our field force as just as important as what we do in the margin profile of the business. Speaker 1000:36:39Great. Thank you so much. Operator00:36:41Thank you very much. At this time, I'm showing no further questions in the queue. This will conclude our question and answer session.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallAdaptive Biotechnologies Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Adaptive Biotechnologies Earnings HeadlinesAdaptive Biotechnologies to Report First Quarter 2025 Financial Results on May 1, 2025April 10, 2025 | globenewswire.comAdaptive Biotechnologies receives expanded medical coverage of clonoSEQApril 9, 2025 | markets.businessinsider.comGet Your Bank Account “Fed Invasion” Ready with THESE 4 Simple StepsStarting as soon as a few months from now, the United States government will make a sweeping change to bank accounts nationwide. It will give them unprecedented powers to control your bank account.April 29, 2025 | Weiss Ratings (Ad)Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ® for Surveillance in Mantle Cell LymphomaApril 8, 2025 | globenewswire.comAnalysts Offer Insights on Healthcare Companies: Siemens Healthineers AG (OtherSEMHF), Adaptive Biotechnologies (ADPT) and Alnylam Pharma (ALNY)March 31, 2025 | markets.businessinsider.comGoldman Sachs Upgrades Adaptive Biotechnologies (ADPT)March 22, 2025 | msn.comSee More Adaptive Biotechnologies Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Adaptive Biotechnologies? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Adaptive Biotechnologies and other key companies, straight to your email. Email Address About Adaptive BiotechnologiesAdaptive Biotechnologies (NASDAQ:ADPT), a commercial-stage company, develops an immune medicine platform for the diagnosis and treatment of various diseases. The company offers immunosequencing platform which combines a suite of proprietary chemistry, computational biology, and machine learning to generate clinical immunomics data to decode the adaptive immune system. It also provides clonoSEQ diagnostic test which detects and monitors the remaining number of cancer cells that are present in a patient's body during and after treatment, known as Minimal Residual Disease (MRD). The company offers products and services for life sciences research, clinical diagnostics, and drug discovery applications. Adaptive Biotechnologies Corporation has strategic collaborations with Genentech, Inc. for the development, manufacture, and commercialization of neoantigen directed T cell therapies for the treatment of a range of cancers; and Microsoft Corporation to develop diagnostic tests for the early detection of various diseases from a single blood test. The company was formerly known as Adaptive TCR Corporation and changed its name to Adaptive Biotechnologies Corporation in December 2011. Adaptive Biotechnologies Corporation was incorporated in 2009 and is headquartered in Seattle, Washington.View Adaptive Biotechnologies ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Alphabet Rebounds After Strong Earnings and Buyback AnnouncementMarkets Think Robinhood Earnings Could Send the Stock UpIs the Floor in for Lam Research After Bullish Earnings?Texas Instruments: Earnings Beat, Upbeat Guidance Fuel RecoveryMarket Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial Earnings Upcoming Earnings QUALCOMM (4/30/2025)Automatic Data Processing (4/30/2025)Microsoft (4/30/2025)Meta Platforms (4/30/2025)KLA (4/30/2025)Equinix (4/30/2025)Lloyds Banking Group (4/30/2025)Itaú Unibanco (4/30/2025)Banco Santander (4/30/2025)Equinor ASA (4/30/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 11 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to the Adaptive Biotechnologies First Quarter 2024 Earnings Call. Please note, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. Operator00:00:27I would now like to hand the conference over to your first speaker today, Corina Calandia, Head of Investor Relations. Please go ahead. Speaker 100:00:37Thank you, Corey, and good afternoon, everyone. Speaker 200:00:40I would like to welcome you to Adaptive Biotechnologies' Q1 2024 earnings conference call. Earlier today, we issued a press release reporting Adaptive financial results for the Q1 of 2024. The press release is available on www.adaptivebiotech.com. We are conducting a live webcast of this call and will be referencing to a slide presentation that has been posted to the Investors section in our corporate website. During the call, management will make projections and other looking forward statements within the meaning of federal securities laws regarding future events and future financial performance of the company. Speaker 200:01:17These 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 filings with the SEC and listed in this presentation. In addition, non GAAP financial measures will be discussed during the call and will be reconciled in non GAAP to GAAP metrics that can be found in the earnings release. Joining the call today are Chad Robbins, our CEO and Co Founder and Kyle Pindzko, our Chief Financial Officer. Additional members from management will be available for Q and A. Speaker 200:01:53With that, I'll turn the call over to Chad Rollins. Chad? Speaker 300:01:57Thanks, Karina. Good afternoon, and thank you for joining us on our Q1 earnings call. As communicated last month and shown on Slide 3, moving forward, both our MRD and Immune Medicine businesses will remain under the adaptive umbrella, each with its own dedicated resources and separate segment reporting. This will provide each business with the autonomy to execute on the respective focused strategies, which are for MRD, marching towards profitability with a strengthened financial profile and for immune medicine, translating science in cancer and autoimmunity into breakthrough therapeutic programs with clear guardrails to guide investment. Importantly, we continue to preserve our strong capital position with approximately $309,000,000 as of March 31, which enables us to bridge the R and D business to profitability and to support targeted investments in immune medicine. Speaker 300:02:58Our position is further strengthened by access to additional non dilutive capital through our agreement with Orbit. Now let's take a closer look at the MRD business on Slide 4. The MRD business had an impressive quarter with $32,600,000 in revenue representing 52% growth versus prior year driven by both clinical and pharma. On the clinical side, volumes continue to grow quarter over quarter with over 17,000 tests delivered in Q1, representing a 41% increase prior year and a 9% increase sequentially. Growth came from all marketed indications and multiple myeloma continues to be the largest contributor, representing approximately 40% of volume. Speaker 300:03:45The diffuse large B cell lymphoma is our fastest growing indication, growing approximately 25% quarter over quarter and now contributing to 5% of total tests. We also continue to be laser focused on driving ASP growth by reducing auto policy and non contracted claims and improving revenue cycle management. Importantly, we are encouraged to see the recent preliminary GAAP bill rate of set by Medicare of $18.23 per test, an increase from our current implied per test rate under the episode structure. Once finalized, this rate would go into effect beginning of 2025. This rate, which will have implications for both Medicare and commercial payer pricing, give us further confidence in our ability to grow ASP per test by $200 over the next 2 years. Speaker 300:04:41In addition, clonoC key indicators continue to trend positive in Q1. Blood based testing represented nearly 40% of tests with multiple myeloma in blood now at 20% following positive data presented at ASH in December. Tests in the community continue to grow sequentially, contributing about 25% of tests delivered. Ordering HCPs and ordering accounts grew 33% 25% versus prior year respectively. Additionally, EMR integration remains central to our efforts to further enhance our customer experience and to solidify our market leadership position. Speaker 300:05:20We saw post integration quarter over quarter growth of 40% across the first four accounts we integrated at the end of 2023 and we now have 9 additional active Epic integrations in motion. Looking at MRD Pharma on Slide 5. Our pharma business started the year strong with Q1 revenue growth of 71% versus prior year. Sequencing revenue grew 17% and we recognized milestones from 2 drug approvals. Last month, the FDA's Oncologic Drug Advisory Committee or ODAC voted unanimously in favor of the use of MRD as a primary endpoint to support the accelerated approval of new therapies for patients with most myeloma. Speaker 300:06:02ODAC's recommendation, if accepted by the FDA, has potential to accelerate myeloma patient access to novel therapies and to reduce drug development costs. In addition to clonaseq being the only FDA cleared MRD assay for patients with multiple myeloma, and it's also the singular assay that can consistently deliver the sensitivity and standardization needed to meet the FDA performance standards. This further solidifies clonosate as the assay of choice for multiple myeloma drug developers. So what does this mean for clonosate? On the revenue recognition front, we can potentially accelerate the realization of revenue from existing studies. Speaker 300:06:42There's also potential to generate new bookings as companies reprioritize their multiple myeloma programs to leverage a faster path to commercialization. On the milestone recognition front, we also have the opportunity to monetize our portfolio primary endpoints from existing MRD Pharma contracts. In addition, this could represent a positive halo effect for the continued acceptance of MRD as a standard measure of response in the clinic. Now let's turn to immune medicine on Slide 6. The I'm business is focused on developing differentiated immune driven therapeutics in cancer and autoimmunity. Speaker 300:07:24In oncology, we continue to support and work closely with our Genentech colleagues in the development of TCR based cell therapy products targeting tumor neoantigens. We're jointly working with Genentech on a holistic review of the programs to enable the development and delivery of the highest impact therapy for patients. Both companies are excited and committed as we move forward with these developments. We'll provide you with an update at the appropriate time. In autoimmunity, we narrowed our focus to select indications in multiple sclerosis and type 1 diabetes, where we believe there is still a high unmet need to develop better, more targeted therapies with a better side effect profile. Speaker 300:08:05Our approach allows us to discover the specific T cells that are attacking itself. Therapeutically, our goal is to eliminate or block the activation of these problem T cells and directly stop them from attacking healthy tissue. In MS and T1D, we've successfully identified the subset of auto reactive T cell receptors that are likely causing these devastating diseases. And in multiple sclerosis, we've confirmed the specific self antigen or target to which these T cell receptors bind. This quarter, we started our antibody discovery campaigns in MS and T1D. Speaker 300:08:41Our goal in 2024 is to discover, make and test select antibodies to generate preclinical data that informs further investment by year end. We continue to gauge our R and D investments based on expected data readouts throughout the year. In Q1, we aligned our resources to execute on these select 2024 programs and specific goals. As a result of these changes, we expect to reduce our immune medicine operating expenses in 2024 by more than 50% versus prior year. The I'm business remains disciplined on its spend and we continue to engage with strategic partners to help offset our cash burn. Speaker 300:09:20Now I'm going to pass it over to Kyle to go through the key financials and provide detail on segment reporting. Kyle? Thanks, Chad. Speaker 400:09:28Let's start with revenue for the Q1 on the left of Slide 7. Total revenue in the Q1 was $41,900,000 with 78% from MRD and 22% from immune medicine. MRD revenue grew to $32,600,000 up 52% from a year ago with clinical testing and MRD Pharma partnerships each driving approximately 48% 12% of the growth respectively, along with a 4,500,000 increase in regulatory milestones. Excluding these milestones, MRD revenue grew 31% from a year ago. Immunomedicine revenue was $9,200,000 down 43% from a year ago, driven largely as expected by lower Genentech amortization, which decreased 49% as well as decreases in I'm pharma services due to a shift in focus towards target and drug discovery efforts. Speaker 400:10:23Moving down the P and L, total operating expenses including cost of revenue were $90,600,000 representing a 4% decrease from last year. This decrease was mainly driven by the continued emphasis on driving leverage across functions and reductions in research and development expenses as we continue to prioritize our investments in Innovate Medicine. Cost of revenue decreased 3%, resulting in gross margin for the quarter of 57 percent, a 7 percentage point increase versus a year ago. This increase was mainly attributed to MRD milestone recognition, partially offset by lower amortization of Genentech upfront. Finally, interest expense from our royalty financing agreement with Orban was $3,000,000 which was more than offset by interest income. Speaker 400:11:10Net loss for the quarter was $47,500,000 compared to $57,700,000 last year, while adjusted EBITDA was a loss of $28,200,000 compared to $37,100,000 in Q1 of 2023. Now turning to segment reporting on the right side of the slide. Restructuring activities during the quarter aligned resources and operations, sales and marketing and R and D towards either the MRD or immune medicine businesses. These resources and related costs are dedicated to each business and are included within the operating spend of MRD and immune medicine respectively. Other corporate functions such as finance, legal, HR and IT continue to be managed centrally to avoid dis synergies from duplication. Speaker 400:11:52We allocate the majority of these corporate expenses to each segment using direct headcount in MRD and immune medicine, which is approximately 75% MRD and approximately 25% I'm Certain expenses will remain unallocated such as our corporate insurance costs, governance, audit fees, our idle facility and interest income and expense, which are reflected under an unallocated corporate segment. In addition to operating expenses per segment, we are also providing adjusted EBITDA, which adjusting for certain income and expense line items can be used as a proxy for cash burn per segment, excluding CapEx and working capital. Now turning to our updated full year guidance on Slide 8. We are updating our MRD full year revenue guidance to $135,000,000 to 140,000,000 dollars bringing up the midpoint of the range to reflect the realization of milestones not previously included in the guidance. With respect to trends throughout the year, we continue to expect MRD revenue to be about 45%, 55% weighted between the first and second half respectively. Speaker 400:12:59For the year, we are lowering the total company estimated operating spend to $350,000,000 to 3.60 dollars a $10,000,000 reduction from our previous guidance as we continue to drive leverage across the businesses and manage investments. Of this total spend approximately 70% sits within the MRD business and approximately 25% within immune medicine. We continue to be thoughtful about our cash position. Excluding one time costs from restructuring activity, we now expect the burn to average approximately $30,000,000 for the remaining three quarters, which implies an annual cash burn of $130,000,000 versus our previous estimate of $140,000,000 dollars This represents a 14% reduction in cash burn over full year 2023. Of note, approximately 50% of the cash burn this year is expected to come from the MRD business and approximately 40% from the immune metal business. Speaker 400:13:52The remaining 10% is due to the unallocated corporate costs. I look forward to providing you with further financial updates throughout the year as we continue to make progress towards our goals. With that, I'll hand it back over to Chad. Speaker 300:14:05Thanks, Kyle. As I think it's evident, we've made important decisions over the last couple of months. I'm confident we're taking the right steps as we move forward with our 2 business segments and execute on the priorities. Our cash position is strong and we're disciplined in managing our capital to bridge the MRD business to profitability, while supporting measured investments in immune medicine to advance our key programs. With that, I'll turn the call back over to the operator and open it up for questions. Speaker 300:14:32Thank you. Operator00:14:34Thank you. At this time, we will conduct a question and answer session. Our first call comes from the line of Mark Massaro from BTIG. Mark, your line is open. Speaker 500:15:00Hey, guys. Congrats on the quarter. Thank you for taking the question. I recognize it's only been about 3 or 4 weeks, but following the FDA ADCOM meeting or ODAC meeting, where multiple myeloma was recommended to be a unanimous primary endpoint in clinical trials for multiple myeloma. Can you just give us a sense for what you've been hearing in the marketplace? Speaker 500:15:28Any of your customers perhaps looking to pick things up a little bit on the clinical trial side? And how do you envision this impacting your business like over the next couple of years? Speaker 300:15:41Yes. Thanks, Mark, for joining the call. I'm going to pass it over to Susan, who can provide quite a bit of color on that. Susan? Speaker 100:15:49Thanks, Chad, and thanks, Mark. Yes, I mean, the ODAC vote, we think it's a huge milestone for the field of myeloma and obviously tremendous news for patients. We have been in active discussions with our pharma partners to discuss potential implications. And while many companies are waiting for the final FDA guidance, which we do expect to be shortly forthcoming, we already have a few studies that have been upgraded primary endpoint as well as a few new studies where MRD is being used a few new studies where MRD is going to be used as a primary endpoint directly as a result of the ODAC vote. In general, as Chad outlined, we see some potential upside in a couple of areas. Speaker 100:16:28First of all, acceleration of primary endpoint milestones that have already been established in ongoing studies. Additionally, upgrading, as I mentioned, of trials that are currently secondary endpoint to primary endpoint status, which will both accelerate the realization of those milestones and also increase their value. And then potentially additional new bookings as pharma companies reprioritize their development programs to center more on back end myeloma. In the clinic, we've also had an opportunity to have quite a few conversations around this topic and clinicians are universally very, very excited on behalf of their patients. They see a tremendous remaining unmet need. Speaker 100:17:09And they also acknowledge the strength that this recommendation coming directly from MODAC and ultimately likely from FDA, provides to the credibility of MRD as a measure of clinical response and as a tool they can use in dialogue with their patients to individualize their care. We really do believe that there is potential for a halo effect, in the clinic as well. Speaker 500:17:35Okay. That's great. And then, it was nice to see the MolDX gap fill rate of 18.23 per test. I think that is scheduled to go live, I think January 2025. How are you thinking about commercial payers? Speaker 500:17:52Is that something that you can potentially initiate that dialogue ahead of the go live date with MolDX? How should we think about that as an incremental driver to the business? Speaker 100:18:05Yes, absolutely, Mark. So you're correct that it will go live formally on January 1 after it's finalized later this year. We are already leveraging the published preliminary rate in conversations with commercial payers. So there are 2 implications in the short term. We have several large non contracted payers who have been holding out waiting for the PLA price to be published so that they could complete their negotiations on price with us. Speaker 100:18:32And so we've already engaged them to advance those negotiations and of those of note and some is a particularly large one that we're working with utilizing the recently published price. Additionally, over time, we can use this price to re approach existing contracted payers to potentially bring up contracted rates that we've previously negotiated if they are below the PLA price. Speaker 300:19:00And one other comment, Mark, worth noting, this as we've mentioned a couple of times, the preliminary pricing rate, obviously, no there's no promise when we continue to work with MolDX on kind of finalizing the price and the episode structure. Speaker 500:19:19That's great. And then one last one for me. You took up the low end of the guide for MRD. I assume that's just cycling in the $4,500,000 milestone that you realized in Q1. Just clarifying that and then how should we think about the total contribution in MRD milestones for the full year? Speaker 400:19:43Yes, Mark, this is Kyle. Yes, the B and the low end pull is fully related to the milestones. As it relates to the go forward, I'd say we continue to be conservative as we think about the milestones in our guidance. We're not necessarily anticipating anything. We don't control the timing and we'll see how it plays out throughout the rest of the year. Speaker 400:20:06It's still early. Speaker 500:20:08Okay. Thanks guys. Speaker 400:20:10Thanks Mark. Operator00:20:12Thank you very much. One moment while we gather our next question. Our next question comes from the line of David Westenberg of Piper Sandler. David, your line is open. Speaker 600:20:24Hi, thank you for taking the question and congrats on all the progress here. I mean, that's a really nice update. The $18.23 it is higher than I remember. I think it was $6,870 for 4. So it was like $1700 a test, which is about a little over $100 Now you said you think that you can have this be $200 so can you run us through the math that gets $200 versus the other difference there? Speaker 600:20:53Also, I just wanted to have a clarification because the last payment was for 4 tests at that 6,000 $870,000,000 rate. With this new rate, does that imply that it's kind of no open end, I mean no closed end after that 4th pass? And I have just one more question. Thank you. Speaker 300:21:13Yes. Maybe I'll start and Susan, please if you want to add color, you can afterwards. Remember, the $200 in ASP raised over the next 2 years is a combination of multiple factors. We talked about reducing out of policy claims and non contracting claims and we're doing a lot of work operationally on revenue cycle management, faster collections, We're actually implementing AI and the appeals process. There's a whole bunch of things that we're doing just to collect money faster. Speaker 300:21:49So as Susan just mentioned, having the new kind of gap fill per price test will also allow us to kind of use that dollar amount to go and close some of those kind of non contracted claims gap that will further enhance it. But if you look at kind of the Medicare percentage of tests, this was this is, I would say, I'm going to call it right now a de risking event to allow us to get to the $200 but it wasn't necessarily contemplated kind of originally in that $200 So I want to be careful, but could represent some potential upside. But certainly, at least all we're looking at right now at least de risking and we're quite confident that we're going to be able to get that $200 increase over the next 2 year period. The second I wasn't sure I totally understood your second question, David, if you could maybe ask it again. Speaker 600:22:45Yes. If I'm not mistaken, your original rate, it was 6,870 for 4 tests. And I wasn't sure after the 4th, like the 5th test, did you get 1750? I don't remember if you actually did. I kind of remember you didn't, but I could be wrong. Speaker 600:23:02I mean, my memory is failing from time to time. So I was thinking if there's any update in terms of being able to get paid in perpetuity versus if there's like a fixed number, rate number of tests. Speaker 300:23:16Yes. So, okay. A couple of comments here, David. On the Medicare episode structure, we don't get paid yet for what we'll call recurrence monitoring. That being said, we have a submission in right now in our first indication for mantle cell lymphoma that we have nice data on our first kind of recurrence monitoring tests that could essentially once a patient goes into remission kind of sets a new bar on a per test rate for Medicare. Speaker 300:23:47Separately, on commercial payers, we don't have a limitation a per case basis, so we can get paid in perpetuity for as many tests as deemed medically necessary. Speaker 600:23:59Got it. Okay. Thank you very much. And just as my follow-up, is there I'm just one of the ODAC meeting, another really positive development here. Is there differences in behavior in the way MRD is used in clinical trials in pharma versus how it's used in clinical? Speaker 600:24:18And specifically, I'm kind of thinking about things like testing interval or testing in terms of timing and when the test is done. And the reason why I'm asking you this question is, does this have a chance to change behavior in the clinic in terms of maybe test frequency and use cases following greater usage in clinical trial and after I'm done after that? Speaker 200:24:46Sure. No, thanks David for the question. Speaker 100:24:48I mean certainly we see that there are synergies in both directions between the MRD pharma and clinical use cases. And depending on the setting in which the trial is being performed, depending on the type of patients who are eligible for the study, the time points and frequency of testing can vary and may also vary in the clinic for those exact same reasons. So while there are no definitive differences that I would call out between clinical and pharma based use of the test, certainly the use is customized to the particular need of the investigator or the clinician and patient. One thing though that I would call out is that in the clinic, blood based testing has begun to really take shape, with about 20% of our MRD test now coming from blood and myeloma. That's something that pharmas have great interest in, but we have not yet really explored in-depth. Speaker 100:25:41And I certainly think that with the incorporation of MRD as an endpoint myeloma, there will be quite a few additional opportunities that will open up, exploration of deeper sensitivity testing in pharma studies as well as potentially use of blood down the road. Speaker 600:25:57Got it. Thank you. And I forgot to give Kyle a congrats on the new position. Thank you. Speaker 400:26:03Appreciate it. Thanks, David. Operator00:26:05Thank you very much. One moment for our next question. Our next question comes from the line of Tom Stevens of TD Cowen. Tom, your line is open. Speaker 400:26:17Hey, guys. Thanks for taking the question here. Speaker 700:26:20Just one on kind of the EBITDA margins by segment and thank you for breaking that out. I guess it looks like today it's kind of negative 50 from about 100 last year and it looks like quite a big lift on an incremental basis to get to breakeven by back half as kind of guided. Clearly, there's a lot of tailwinds there. There's the pricing tailwinds. There's the switch to the X. Speaker 700:26:43But I guess, could you break out maybe in a more granular way for investors just how you get to that breakeven by next year? Speaker 400:26:53Yes. I mean, I'll talk, I mean broadly, obviously the ASP initiatives are a big factor, margin improvements to reduce our kind of per volume test costs. And really the biggest driver is the leverage throughout our operating expenses both on the sales team and those margin profiles at the end Speaker 300:27:16of the day as we continue Speaker 400:27:17to grow ASPs and the pharma business. Speaker 300:27:20Yes. I mean, Tom, it's 3 things, right? It's raising the price per test, it's lowering the cost that we deliver each test and it's continued to look at kind of operating expenses, and we're doing all 3. And you can see that we've made improvements and kind of reduced the operating expense for the year of $10,000,000 We continue to look at ways that we can kind of reduce expenses and gain leverage and we will do so. Speaker 400:27:50Great. And Speaker 700:27:52then yes, go on, sorry. Speaker 400:27:53Just to reiterate, back half of twenty twenty five adjusted EBITDA breakeven and then the cash flow is not till 26. So just to make sure that we're clear on that. Speaker 700:28:03Yes, definitely. And then just a question on kind of blood, you kind of mentioned it's now 20% of your multiple myeloma volumes. What reimbursement rate are you getting on blood versus your kind of more traditional bone marrow or spinal tap? Speaker 100:28:21Our reimbursement rates aren't distinguished by sample type. So, our coverage policy, both for Medicare and for majority of private payers are sample agnostic. So coverage applies both to bone marrow and to blood based testing for myeloma. Operator00:28:46Our next question comes from Sung Ji Nam of Scotiabank. Sung, your line is open. Speaker 800:28:53Hey, this is Corey Rosenbaum on for Sung Ji. Thanks for taking my questions. So with the recent FDA ODAC recommendation, during the meeting, there a big discussion around the 10 to the minus 6 sensitivity threshold. Are any of the existing trials using climacy currently differentiating between 10 to the minus 5 and 10 to the minus 6? Just wondering how the industry may be able to start evaluating the differences between these two sensitivity thresholds? Speaker 800:29:18Thanks. Speaker 100:29:20Yes. Thanks for the question, Cory. Absolutely, a number increasingly studies are being designed to differentiate between 10 to the 5th and 10 to the 6 sensitivity and of course, clonoSeq is really the singular assay that can deliver that level of sensitivity consistently with a reasonable sample input and with the standardization across patients. So what we are actually hearing from the investigators who were central to the preparations and the data that went into support for the ODAC meeting couple of weeks ago, they acknowledged that most of the data historically that was able to be analyzed was at negative 5th. But the group, the KOLs have moved on to 10 of the 6th as the real important standard threshold And they are already anticipating pursuing additional engagements with the FDA over the coming months years to move that threshold to 106 over time. Speaker 800:30:22Awesome. Thank you. That's all for me. I'll hop back to the queue. Operator00:30:26Thank you very much. One moment for our next question, please. Our next question comes from the line of Tejas Savant of Morgan Stanley. Tejas, your line is open. Speaker 900:30:39Hello, this is Yigal on for Tejas. Thank you for taking our questions. Where are you in the restructuring and resource allocation process, the increased independence between the two reporting segments today? Are there any work that remains to be done heading into the back half or are they in good place operationally? Speaker 400:30:57I'd say the 90% of the work has been done. In Q1, we realigned the workforce and most of that was aligning operations and R and D investments around each of the businesses. That work is complete. We still have a little bit of transitory processes in extracting the immune medicine pharma services lab from our production lab for the MRD business, but that's the only kind of remaining activity. So by and large, everything is done and we're operating in that vein today. Speaker 900:31:31Great. And then asking a question on the ODAC meeting. Following the AdCom, how do you see FDA receptibility to discussing MRD as an endpoint in other Are there particular features of trials that may not read through to other heme indications like ALL, CLL or DLBCL? Speaker 100:31:56Yes. Thank you for the question. In fact, that's Speaker 200:31:59a question that was of Speaker 100:32:00great interest to us as well. And certainly, we do anticipate that this FDA likely FDA decision following the ODAC vote will pave the way for further discussion with the FDA about MRD as an endpoint and other indication. The one that investigators have expressed most interest to us about is CLL. And that is one for which currently the thresholds that are utilizing guidelines and in many trials are 104. But just like in myeloma, there's interest in continuing to move that threshold further to the benefit of patients. Speaker 100:32:35And so we're already actively engaging with investigators to talk about how we might potentially support those efforts, providing data, and supporting studies that are already being designed. We've also had conversations with our pharma partners. And interestingly, many of those who we've talked to with the intent of focusing on myeloma are actually taking a bigger picture view and looking across their portfolios to think about how they might proactively leverage MRD more prospectively in anticipation of the FDA essentially being more open to MRD data across hematologic malignancies in the forthcoming time. Speaker 900:33:16Great. Thank you very much. Operator00:33:19Thank you very much. One moment for our next question. Our next question comes from Andrew Brackmann of William Blair. Andrew, your line is open. Speaker 1000:33:33Hi, everyone. This is Maggie Bui on for Andrew today. I wanted to ask one on the progress of the EMR integration. I know you spoke to earlier some strong growth in the quarter from customers, but just wanted to know like what feedback has been for the accounts that you've recently added? And then how many more accounts do Speaker 200:33:51you expect to be able Speaker 1000:33:52to add this year? And then how is this factoring into growth assumptions? Speaker 100:33:57Yes. Thank you for the questions, Maggie. We are hearing very positive feedback. As you might imagine, it makes the assay significantly easier to use both from an ordering perspective and in terms of integrating the results directly into the patient's chart for clinical use. We have 9 active projects that Chad mentioned currently in motion with IT departments at the specific sites. Speaker 100:34:24We have dozens of additional sites that are in conversations, securing IT resources, going through various approval processes, and we are ready to go with any account that's ready to move. I'll note that some of the accounts that are in active IT development are among our largest accounts. And in fact, 15 of our 20 largest accounts are Epic customers. So we're very eager to move those forward and to ensure that a meaningful portion of our volume goes through Epic over the next 1 to 2 years. We do anticipate by the end of this year, continue to expect between 2025 accounts to be integrated. Speaker 100:35:06That will represent somewhere between 15% 20 percent of our volume we expect. And we expect to continue to increase the speed whereby we can get these accounts up and running. Our most recent projects are trending toward about a 7 week timeline, which is really nicely aligned with industry standards for integration. Speaker 1000:35:28Great. Thank you so much. And then I wanted to ask another one on improving gross margins just as I know that's one of the drivers to reach your profitability targets for MRD. Can you talk about the progress of some of the initiatives there such as the transition to NovaSeq and the LEMS overhaul and how these are progressing? How should we be thinking about these driving improvements in gross margins over time? Speaker 1000:35:50Thank you. Speaker 400:35:52Yes. I mean, I think 1st and foremost on the gross margins ASP initiatives, we're starting to see kind of some of that pull through with strong collections subsequent to the quarter. As it relates to the costing profile of the assay with the transition in OOC, in OCC. I think of that as a 25% of that. We're still undergoing the development aspects of that and assessing that. Speaker 400:36:14So I view that as 25%. And then I think the other thing to just note is overall as a company, we're going to continue to look at everything we can do to streamline operations and continue to gain leverage without increasing expenses to get to that profitability metric. So I think of leveraging our field force as just as important as what we do in the margin profile of the business. Speaker 1000:36:39Great. Thank you so much. Operator00:36:41Thank you very much. At this time, I'm showing no further questions in the queue. This will conclude our question and answer session.Read morePowered by