Adaptive Biotechnologies (NASDAQ:ADPT) has announced its financial results for the first quarter of 2024, showcasing significant growth in its Minimal Residual Disease (MRD) business with a 52% revenue increase to $32.6 million.
The company's total revenue reached $41.99 million, with MRD contributing 78%. Adaptive Biotechnologies has updated its full-year MRD revenue guidance to $135 million to $140 million and reduced its estimated total operating spend to $350 million to $360 million.
The company is also optimizing its Immune Medicine business, expecting to slash operating expenses by more than 50% in 2024 and is engaging in strategies to increase its average selling price over the next two years.
Key Takeaways
- MRD business revenue grew by 52% to $32.6 million, with a 41% increase in clinical volumes.
- Full-year revenue guidance for MRD is now $135 million to $140 million.
- Immune Medicine business to reduce operating expenses by over 50% in 2024.
- Total operating spend lowered to $350 million to $360 million for the year.
- The company expects an annual cash burn of $130 million, a 14% reduction from previous estimates.
- Adaptive Biotechnologies is leveraging recent Medicare gap-fill rates in payer negotiations.
Company Outlook
- Adaptive Biotechnologies anticipates reducing auto policy and non-contracting claims while improving revenue cycle management.
- The company's strategy includes leveraging the preliminary Medicare gap-fill rate to potentially increase contracted rates with existing payers.
- The path to break-even is expected to be achieved in the back half of next year through price increases per test, cost reductions, and operating expense management.
Bearish Highlights
- The company is managing a significant cash burn, with MRD and Immune Medicine businesses contributing to 90% of the total.
Bullish Highlights
- The company is confident in its cash position and its ability to bring the MRD business to profitability.
- There is growing interest in blood-based testing, which could lead to increased usage in clinical trials.
Misses
- There were no specific misses mentioned in the provided context.
Q&A Highlights
- Positive feedback has been received on the EMR integration, which is expected to cover 15-20% of the company's volume by the end of the year.
- The company is focusing on initiatives such as transitioning to NovaSeq and overhauling their LIMS system to improve gross margins.
- Adaptive Biotechnologies is actively engaging with pharma partners to discuss the implications of the recent FDA ODAC vote.
In conclusion, Adaptive Biotechnologies is making strides in the MRD market and taking strategic steps to improve its financial health and market position. The company remains focused on leveraging technological advancements and regulatory changes to enhance its business operations and profitability.
InvestingPro Insights
Adaptive Biotechnologies has shown resilience in its MRD business with a significant revenue uptick, yet the broader financial picture as captured by InvestingPro data indicates areas of caution. With a market capitalization of $458.32 million, the company's valuation reflects investor sentiment towards its growth potential and market position. However, the P/E ratio, both standard and adjusted for the last twelve months as of Q4 2023, stands at -2.02 and -2.17 respectively, signaling that the company is not currently generating profits relative to shareholder equity.
InvestingPro Tips highlight key financial health indicators for Adaptive Biotechnologies. On the positive side, the company holds more cash than debt, which is an encouraging sign of financial stability. Additionally, liquid assets exceed short term obligations, suggesting that the company has the liquidity to meet its immediate financial responsibilities. Yet, it's important to note that Adaptive Biotechnologies is quickly burning through cash and analysts do not anticipate the company will be profitable this year. This is reflective of the company's strategy to optimize its Immune Medicine business and manage operating expenses, as outlined in the article.
For readers interested in a deeper dive into Adaptive Biotechnologies' financial metrics and strategic outlook, there are additional InvestingPro Tips available. These tips provide further insights that could be pivotal in making informed investment decisions. By using the coupon code PRONEWS24, users can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro, which includes these valuable tips. Currently, there are six more tips listed on InvestingPro for Adaptive Biotechnologies, which could enrich investors' understanding of the company's financial trajectory and market dynamics.
The InvestingPro Fair Value estimate stands at $4.61, which may guide investors in assessing the stock's potential for growth against market expectations. As Adaptive Biotechnologies continues to navigate its path towards profitability, these InvestingPro insights can serve as a valuable resource for investors tracking the company's progress.
Full transcript - Adaptive Biotechnologies Corp (ADPT) Q1 2024:
Operator: Good day and thank you for standing by. Welcome to the Adaptive Biotechnologies First Quarter 2024 Earnings Call. Please note, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised today’s conference is being recorded. I would now like to hand the conference over to your first speaker today, Karina Calzadilla, Head of Investor Relations. Please go ahead.
Karina Calzadilla: Thank you, Corey, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies first quarter 2024 earnings conference call. Earlier today, we issued a press release reporting Adaptive financial results for the first quarter of 2024. The press release is available at www.adaptivebiotech.com. We are conducting a live webcast of this call and we’ll be referencing to a slide presentation that has been posted to the Investors section on our corporate website. During the call, management will be making projections and other forward-looking statements within the meaning of federal securities 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 filings 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 Robins, our CEO and Co-founder; and Kyle Piskel, our Chief Financial Officer. Additional members from management will be available for Q&A. With that, I will turn the call over to Chad Robins. Chad?
Chad Robins: Thank you for Karina. Good afternoon and thank you for joining us on our first quarter earnings call. As communicated last month and shown on slide three, 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 and cancer and auto-immunity into breakthrough therapeutic programs with clear guardrails to guide investment. Importantly, we continue to preserve our strong capital position with approximately $309 million as of March 31st, which enables us to bridge the MRD business to profitability and to support targeted investments in Immune Medicine. Our position is further strengthened by access to additional non-dilutive capital through our agreement with OncoEMR. Now let's take a closer look at the MRD business on slide four. The MRD business has an impressive quarter with $32.6 million 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 for prior year and a 9% increase sequentially. Growth came from all market indications and multiple myeloma continues to be the largest contributor representing approximately 40% of volume. The few sludge [ph] diesel 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 ASD growth by reducing auto policy and non-contracting claims and improving revenue cycle management. Importantly, we are encouraged to see the recent preliminary gap bill rate set by Medicare of $1,823 per test and 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 two years. In addition, clonoSEQ key indicator continue to trend positive in Q1. Blood-based testing represented nearly 40% of tests with multiple myeloma in blood, now like 20% following positive data presented in ASH in December. Chests in the community continue to grow sequentially, contributing about 25% of tests delivered. Ordering HCPs and ordering accounts grew 33% and 25% versus priority or respectively. Additionally, EMR integration remains central to our efforts to further enhance our customer experience and to solidify our market leadership position. We 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 nine additional active epic integrations in motion. Looking at MRD, farm 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 two 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 acceleration or approval of new therapies for patients with most myeloma. ODAC's recommendation is accepted by the FDA has potential to accelerate myeloma patient access to novel therapies and to reduce drug development costs. In addition to clonoSEQ, the only FDA-cleared MRD assay for patients with most myeloma, it is also the singular assay that can consistently deliver the sensitivity and standardization needed to meet the FDA performance standards. This further solidifies clonoSEQ as the assay of choice for multi-myeloma drug developers. So, what does this mean for clonoSEQ? On the revenue recognition front, we can potentially accelerate the realization of revenue from existing studies. There is also potential to generate new bookings as companies re-prioritize their multi-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 the existing MRD pharma contracts. In addition, this could represent a positive table 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 six. The IM business is focused on developing the differentiated immune-driven therapeutics in cancer and auto immunity. In oncology, we continue to support and work closely with our genetic 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 auto immunity, we narrow our focus to select indications and multiple sclerosis and type 1 diabetes, where we believe there is still a high unmet need to develop better or targeted therapies with a better side effect profile. Our approach allows us to discover the specific T cells that are attacking cells. 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 successfully identify the subset of auto-reactive T cell receptors that are likely causing these devastating diseases. And in multiple sclerosis, we can confirm the specific self-adagent or target to which these T cell receptors bind. This quarter, we started our antibody discovery campaigns in MS and T1D. Our 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&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 IM business remains disciplined on its spend and we continue to engage with strategic partners to help offset our cash burn. Now, I'm going to pass it over to Kyle to go through the key financials and provide detail on the second report. Kyle?
Kyle Piskel: Thanks. Thanks, Chad. Let's start with revenue for the first quarter on the left of slide 7. Total revenue in the first quarter was $41.99 million, 78% from MRD and 22% from Immune Medicine. MRD revenue grew to $32.6 million, up 52% from a year ago, with clonoSEQ clinical testing and MRD pharma partnerships each driving approximately 48% and 12% of the growth perspective, along with a 4.5 million increase in regulatory milestones. Excluding these milestones, MRD revenue grew 31% from a year ago, and the Immune Medicine revenue was $9.2 million, down 43% from a year ago, driven largely, as expected by lower genetic amortization, which decreased 49%, as well as decreases in IM pharma services due to a shift in focus towards target and direct discovery efforts. Moving down the P&L, total operating expenses, including costs of revenue, were $90.6 million, 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 it. Cost of revenue decreased 3%, resulting in gross margins for the quarter of 57%, a 7% point increase versus a year ago. This increase was mainly attributed to MRD milestone recognition, partially offset by lower amortization of Genentech. Finally, interest expense from our royalty financing agreement with ODAC was $3 million, which was more than offset by interest income. Net loss for the quarter was $47.5 million compared to $57.7 million last year, while adjusted EBITDA was a loss of $28.2 million compared to $37.1 million 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&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 disenergizing from duplication. We 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% high end. 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. Updating our MRD full-year revenue guidance to $135 million to $140 million, bringing up the midpoint of the range to reflect the realization of milestones not previously included in the guide. 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 respects. For the year, we are lowering the total company estimated operating spend to $350 million to $360 million, a $10 million 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 million for the remaining three quarters, which implies an annual cash burn of 130 million versus our previous estimate of 149. 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 Medicine business. The remaining 10% is due to the unallocated corporate cost. 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.
Chad Robins: Thank you, Kyle. As I think it's evident, we've made important decisions over the last couple months. I'm confident we're taking the right steps as we move forward with our two business segments and execute on the priorities. Our cash position is strong and we're disciplined and managed 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 up for questions. Thank you.
Operator: Thank you. [Operator Instructions] Our first call comes from the line of Mark Massaro from BTIG. Mark, your line is open.
Mark Massaro: Hey, guys. Congrats on the quarter. Thank you for taking the question. I recognize it's only been about three or four 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? Any of your customers perhaps looking to pick things up a little bit on the clinical trial side? How do you envision this impacting your business over the next couple of years?
Chad Robins: Yes. Thanks, Mark, for joining the call. I'm going to pass it over to Susan who can provide quite a bit of color in that. Susan.
Susan Bobulsky: Thanks, Chad, thanks Mark. The ODAC vote, we think it's a huge milestone in the field of myeloma and obviously tremendous news for patients. We have been in active discussions with our pharma partners to discuss the potential implications. 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 to primary endpoint, as well as 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. First 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 in 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. And they also acknowledge the strength that this recommendation coming directly from ODAC 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.
Mark Massaro: Okay, that's great. And then it was nice to see the Moldex gap-fill rate of 1,823 per test. I think that is scheduled to go live, I think, January 2025. How are you thinking about commercial payers? Is that something that you can potentially initiate that dialogue ahead of the go live date with Moldex? How should we think about that as an incremental driver to the business?
Susan Bobulsky: Yes, absolutely, Mark. So you're correct that it will go live formally on January 1st after it's finalized later this year. We are already leveraging the published preliminary rate in conversation with commercial payers. So there are two 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. And so we've already engaged them to advance the negotiations. And of those of note, Ansem [ph] 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.
Chad Robins: And one other comment, Mark, worth noting, as we mentioned a couple of times, the preliminary pricing rate. Obviously, there's no promise that we continue to work with Moldex on finalizing the price and the episode structure.
Mark Massaro: That'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 $4.5 million 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?
Kyle Piskel: Yes, Mark, that's Kyle. Yes, the beat and the low end poll 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 guide. 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 still early.
Mark Massaro: Okay, thanks, guys.
Operator: Thank you very much. One moment while we gather our next question. Our next question comes from the line of David Westenberg of Piper Sandberg. David, your line is open.
David Westenberg: Hi. Thank you for taking the question and congrats on all the progress here. I mean, that's a really nice update, the 1823. It is higher than I remember. I think it was up $6,874 [ph]. So it was like $1,700 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 to $200 versus the other difference there? Also, I just want to have a clarification because the last payment was for four tests at that $6,870 rate. With this new rate, does that imply that it's kind of no open end? I mean, no closed end after that fourth test. And I just want more question. Thank you.
Chad Robins: Yes, maybe I'll start, Susan, if you want to add color, you can add the word. Remember, the $200 in ASP raised over the next two years is a combination of multiple factors. We talked about reducing auto policy claims and non-contracted 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. So as Susan just mentioned, having the new gap bill per price test will also allow us to use that dollar amount to go and close some of those non-contracted claims gap that will further enhance it. But if you look at the Medicare percentage of tests, this is, I would say, I'm going to call it right now a risky event to allow us to get to the $200. But it wasn't necessarily contemplated 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 is at least de-risking, and we're quite confident that we're going to be able to get that $200 increase over the next two-year period. The second, I wasn't sure I totally understood your second question, David, if you could maybe ask it again.
David Westenberg: If I'm not mistaken, your original rate was $6870 for four tests. And I wasn't sure after the fourth, like the fifth test, did you get $17.50? I don't remember if you actually did. I kind of remembered you didn't, but I could be wrong. I mean, my memory was 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.
Chad Robins: Yes, 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 test that could essentially, once a patient goes into remission, kind of sets a new bar on a per test rate for Medicare. Separately, on commercial payers, we don't have a limitation on a per case basis so we can get paid in perpetuity for as many tests as deemed medically necessary.
David Westenberg: Got it. Okay. Thank you very much. And just as my follow up, is there, I just want to be 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? And 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?
Susan Bobulsky: Sure. No, thanks, David, for the question. I 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 tests now coming from blood and myeloma. That's something that pharmas have great interest in, but we have not yet really explored in depth. And I certainly think that with the incorporation of MRD and 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 potential use of blood down the red.
David Westenberg: Thank you. And I forgot to give Kyle a congrats on the new position. Thank you.
Kyle Piskel: Appreciate it. Thanks, David.
Operator: Thank 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.
Tom Stevens: Hey guys, thanks for taking the question here. Just 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 negative 100 last year and it looks like quite a big lift on an incremental basis to get the break-even by back half as kind of guided. Clearly, there's lots of tailwinds there. There's the pricing tailwind. There's the switch to the X, but I guess could you break out maybe in a more granular way for investors just how you get to that break-even by next year?
Chad Robins: Yes, 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 of the day as we continue to grow ASPs and the pharma business.
Kyle Piskel: Yes I mean, Tom, it's three things, right? It's raising the price per test. It's lowering the cost that we deliver each test and it's continuing to look at operating expenses. And we're doing all three. And you can see that we've made improvements and kind of reduced the operating expense for the year of $10 million. We continue to look at ways that we can kind of reduce reduced expenses and gain leverage and we will do so.
Tom Stevens: Great. Go on, sorry.
Kyle Piskel: Just to reiterate, back half of $25 adjusted even at break-even and then the cash flow is not till $26 just to make sure that we're clear.
Tom Stevens: Yes, definitely. And then just a question on kind of blood [ph]. You kind of mentioned it's now 20% of your multimyeloma volumes. What reimbursement rate are you getting on blood versus your kind of more traditional bone marrow or spinal tap?
Susan Bobulsky: Our reimbursement rates aren't distinguished by sample type. So our coverage policy, both for Medicare and for high-payers, our sample had contact. So coverage applies both to bone marrow and to blood-based testing for myeloma.
Tom Stevens: Wonderful. Thanks very much. I'll hop back in the queue.
Operator: Thank you very much. One moment for our next question, please. Our next question comes from Sung Ji Nam of Scotiabank. Sung, your line is open.
Unidentified Analyst: Hey, this is Corey Rosenbaum [ph] on for Sung Ji. Thanks for taking my questions. So with the recent FDA ODAC recommendation during the meeting, there was a big discussion around the 10 to the minus 6 sensitivity threshold. Are any of the existing trials using clinical disease 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. Thanks.
Susan Bobulsky: Yes, thanks for the question, Corey. Absolutely. A number, increasingly, studies are being designed to differentiate between 10 to the 5th and 10 to the 6th sensitivity. And of course, clinical disease is really the singular assay that can deliver that level of sensitivity consistently with a reasonable sample input and with a 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 a couple of weeks ago, they acknowledged that most of the data historically that was able to be analyzed was at 10 to the negative 5th. But the group, the KOLs have moved on to 10 to the 6th as the real important standard threshold. And they are already anticipating pursuing additional engagements with the FDA over the coming months and years to move that threshold to 10 to the 6th over time.
Unidentified Analyst: Awesome. Thank you. That's all for me. I'll head back to the queue.
Operator: Thank you very much. One moment for our next question, please. Our next question comes from the line of Tejas Savant of Morgan Stanley (NYSE:MS). Tejas, your line is open.
Unidentified Analyst: Hello, this is Hugo [ph] on for Tejas. Thank you for taking our questions. Where are you in the restructuring and resource allocation process to increase 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?
Chad Robins: I'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&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 and Pharmacervic Services Lab from our production lab for the MRD business, but that's the only kind of remaining activity. So by and large everything's done and we're operating in that vein today.
Unidentified Analyst: Great. And then asking a question on the ODAC meeting. Following the adcom, how do you see FDA receptability to discussing MRD as an endpoint in other HIEM [ph] indications? Are there particular features of MM trials that may not read through to other HIEM indications like ALL, CLL, or DLBCL?
Susan Bobulsky: Thank you for the question. In fact, that's a question that was of great interest to us as well, and certainly we do anticipate that this FDA, likely FDA decision following the ODAC will pave the way for further discussion with the FDA about MRD as an endpoint in other indications. The one that investigators have expressed the most interest to us about is CLL, and that is one for which currently the thresholds that are utilized guidelines in many trials are 10 to the fourth. But just like in myeloma, there's interesting continuing to move that threshold further to the benefit of patients. And so we're already actively engaging with investigators to talk about how we might essentially 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, MRD more prospectively in anticipation of the FDA potentially being more open to MRD data across hematologic malignancies in the fourth coming time.
Unidentified Analyst: Great. Thank you very much.
Operator: Thank you very much. One moment for our next question. Our next question comes from Andrew Brackmann of William Blair. Andrew, your line is open.
Unidentified Analyst: Hi, everyone. This is Maggie Builian [ph] 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 what feedback has been for the accounts that you've recently added, and then how many more accounts do you expect to be able to add this year, and then how is this factoring into gross assumptions?
Susan Bobulsky: Yes. Thank you for our 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 patients chart for clinical use. We have nine active projects that Chad mentioned currently in motion with IT departments at the specific sites. We have dozens of additional sites that are in conversation securing IT resources going through various approval processes. 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. 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 one to two years. We do anticipate by the end of this year, continue to expect between 20 and 25 accounts to be integrated. That'll represent somewhere between 15 and 20 percent of our volume we expect. 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 seven-week timeline, which is really nicely aligned with industry standards for our integration.
Unidentified Analyst: Great, thank you so much. And I wanted to ask another one on improving gross margins. One of the drivers to reach your profitability target frame are RD. Can you talk about the progress of some of the initiatives there, such as the transition to NovaSeq and the LIMS overhaul and how these are progressing? How should we be thinking about these driving improvements in gross margins over time? Thank you.
Chad Robins: Yes, I think first and foremost on the gross margins ASP initiatives, we're starting to see some of that pull through with some strong collections subsequent to the quarter. As it relates to the costing profile of the assay with the transition to NovaSeq, I think of that as a 25 event. We're still undergoing the development aspects of that and assessing that. I view that as 25. 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 line 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 business.
Unidentified Analyst: Great, thank you so much.
Operator: Thank you very much. At this time, I'm showing no further questions in the queue. This will conclude our question-and-answer session. Thank you for participating in today's conference. This does conclude the program. You may now disconnect.
Chad Robins: Thank you.
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