Neogenomics Inc (NEO) Q3 2023 Earnings Call Transcript

Greetings. Welcome to the NeoGenomics Third Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. Please note this call is being recorded, and an audio replay will be available on the company's website. Kendra Sweeney, Vice President of Investor Relations, you may begin your conference.

Thank you, John. Good afternoon, everyone, and welcome to the NeoGenomics third quarter financial results call. With me today to discuss the results are Chris Smith, Chief Executive Officer, and Jeff Sherman, Chief Financial Officer. Additional members of the management team are available for Q&A including Vishal Sikri, President of Advanced Diagnostics; Warren Stone, President of Clinical Services; and Melody Harris, President of Enterprise Operations. This call is being simultaneously webcast. We will be referring to a slide presentation that has been posted to the Investors tab on our website at ir.neogenomics.com. Starting on Slide 2, during this call, we'll be making forward-looking statements regarding our anticipated future performance. We caution you that such statements reflect our best judgment based on factors currently known to us, and that actual events, or results could differ materially. Please refer to our most recent forms 10-K, 10-Q, and 8-K we filed with the SEC to identify important risks and other factors that may cause our actual results to differ materially from the forward-looking statements. The forward-looking statements made during this call speak only as of the original date of the call, and we undertake no obligation to update or revise any of these statements. During this call, in order to provide greater transparency regarding our operating performance, we refer to certain non-GAAP financial measures that involve adjustments to GAAP results. The non-GAAP financial measures presented should not be considered an alternative to the financial measures required by GAAP, should not be considered measures of liquidity, and are unlikely to be comparable to non-GAAP financial measures provided by other companies. Any non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measure in a table available in the press release we issued this afternoon. I will now turn the call over to Chris Smith, Chief Executive Officer of NeoGenomics.

Thanks, Kendra, and welcome, everyone. Thanks for joining us this afternoon to go through our third quarter financial results. As always, I want to begin with our mission, our vision statement because it’s what motivates our company and teammates on a daily basis. Our mission at Neo is to save lives by improving patient care. Before we dive in, I also want to thank the 2,200 team mates for the impact they are making on patients' lives every single day. Now, let's move to Slide 4 and get into the third quarter highlights. As you can see, we had another very strong quarter growing revenue 18% over the prior year. Clinical Services revenue increased 20%, driven by strong volumes across our modalities, and an increase in revenue per test. As a highlight, NGS grew in excess of 35%, and now represents approximately 25% of our total clinical revenue. Advanced Diagnostics revenue, which includes pharma services and informatics, increased 8% from prior year, driven by continued growth in informatics in ramp and RaDaR. As we continue to execute on the transformation of the business, our progress has outpaced our internal plans. We started the year with the outlook that we would be adjusted positive in the fourth quarter. However, in the third quarter, adjusted EBITDA significantly improved 129% as compared to Q3 of last year, to a positive $3 million. Adjusted gross profit was $67 million, representing a 25% increase over the prior year, or 44%. For the 10th consecutive quarter, we saw an increase in revenue per test versus prior year. NGS growth continues to be a driver of improvements in revenue per test, and is growing well above the estimated market growth. In addition, revenue cycle management and pricing initiatives also are contributing to revenue growth per test. In terms of other key quarterly business updates, we completed three submissions to MolDX including one additional breast application, as well as two new indications, one in lung, and one in head and neck. Slide 5 demonstrates the consistent performance with the third quarter delivering sustained improvement in revenue, gross margin, and adjusted EBITDA. We are proud of this year-over-year accelerated growth because it's a direct result of the strong execution by our Neo teammates, and the growing demand for our products from existing clients, as well as new customers. Our operating and revenue cycle initiatives implemented in the second half of 2022 continue to enable accelerated growth, and we believe they have the ability to continue to drive improvement in the business through the end of the year and beyond. Let's move on to Slide 6. We've kept the narrow focus on our strategic priorities laid out at the beginning of the year: profitably grow the core business, accelerate Advanced Diagnostics, drive value creation, and enhance people and culture. Our Neo teammates are the foundation of the company, and continuing to enhance this team and our strong mission-driven culture is critical to our long-term success. This afternoon, I'm going to focus on our other financial priorities. We continue to profitably grow our core clinical business as we execute our commercial strategy, which is protect, expand, and acquire. This has helped us deliver strong volume and improved mix. Our continued improvement in turnaround time has allowed all modalities to grow faster than the market. In addition, the mix shift towards more comprehensive panels has supported the delivery of yet another quarterly improvement in revenue per test. Clinical adjusted gross profit increased to $13 million or 28% versus the prior year. Our newest NGS CTP panel for heme malignancies, Neo Comprehensive - Heme, was launched a few weeks ago and strengthens our leadership position in the heme oncology services. We also launched a therapy selection panel, providing a comprehensive overview of biomarkers for detecting early stage lung cancer. Finally, we continued our sales force expansion that we disclosed in Q2. Within the Advanced Diagnostics division, which includes pharma services, informatics, and R&D, we continue to focus on innovation. As mentioned, during the third quarter, we submitted three RaDaR applications to MolDX, collectively now have 27 studies in progress utilizing RaDaR technology. Some of these are interventional trials, including Meridian in head and neck, CAN, HER2 in breast and a randomized ctDNA lung trial. In December, additional RaDaR breast cancer data will be presented at the San Antonio Breast Cancer Symposium, and we also have three posters featuring other Neo - Heme modalities accepted at ASH. We hired a new Head of R&D, who will implement a new structure, focus on accelerating new product development, and driving innovation that will benefit our clinical and pharma customers. While it's still early days with RaDaR, we are very pleased that our technologies are capturing low positive clinical samples, highlighting the value of sensitivity for RaDaR. We are focused on driving value creation from a financial perspective and are pleased that we've delivered even further margin expansion from Q2, and have generated significant operating leverage as revenue favorability fell through to the bottom line. As we continue to optimize our lab operation, we achieved approximately a 20% improvement in turnaround time over Q2. Because of several key acquisitions over the last five years, we've been operating under multiple LIMS systems. To further enhance operating efficiencies, we launched a key initiative to move the organization to one LIMS system. This project will provide a new system, which will become the backbone of digitization of our labs, allowing for tighter integration between our CRM system, ordering systems, and ERP back end, and allow for increased efficiency across our entire enterprise. We'll start to see the benefits in 2024. To further reduce costs, and improve margins, we've completed the consolidation of our international labs into one lab in Cambridge, UK, and have improved processes on procurement and supply chain. We expect to see these benefits continue in 2024 and beyond. Before I turn the call over to Jeff, I want to take a minute to address the FDA's proposed unilateral regulation of lab-developed tests as medical devices. Given the substance of the proposed rule is in draft form, the agency has requested public comments on the topics, that includes grandfathering. It is important to note that many instances around this topic are still hypothetical. That being said, Neo has a strong history of complying with CAP and CLIA regulatory standards, and we have also been working with MolDX on coverage termination. We believe these factors, taken together, give us a head start over many other reference labs and providers performing similar testing. We have operated our business in preparation for regulations for some time now, and have executives and teams in place, who have experience with the FDA approval process including quality, regulatory, and R&D. Furthermore, our assay development over the last 12 months to 18 months has been incorporating FDA design control, and preparation for future submissions. As a member of ACLA, we will work with the association to ensure the continuation of patient care with limited business impact. Now, let me turn the call over to Jeff to review our financial results in more detail.

Thanks, Chris, and good afternoon, everyone. I'll begin with a little more detail on our operating results for the quarter. As Chris said, we continued the year with revenue experiencing accelerated double-digit growth over the prior year. Third quarter revenue was $152 million, an 18% increase over the prior year and a 3.4% increase from Q2 of '23. Revenue growth was driven by growth in clinical test volume, a continuing shift to higher complexity tests, and improvement in revenue per test driven by business mix and revenue cycle improvements. Adjusted EBITDA improved 129% from prior year to a positive $3 million. Q3 marks the fourth consecutive quarter that adjusted EBITDA increased from prior year. We generated significant operating leverage as revenue favorability flowed through to the bottom line, with over 60% of revenue growth flowing to adjusted EBITDA. Looking at Slide 8, Clinical Services revenue of $128 million was an increase of 20% year-over-year, driven by a 7% increase in volume, and a 12% increase in revenue per test. Higher volume is driven by growth within our existing client base, as well as newly acquired customers, and demonstrates that our sales force optimization strategy is enabling us to reach the oncologists, pathologists, and other physicians and providers we serve. Turning to Slide 9, average revenue per clinical test increased by 12% over prior year to $440, representing an improvement for the 10th consecutive quarter versus prior year, as we maintain our focus on higher value tests, and revenue cycle management initiatives. As we've previously noted, NGS growth is a focus of our sales team, with NGS revenue approaching approximately 25% of our total clinical revenue for the year. As a result of our strong performance in NGS, and the expansion in our sales team, we continue to see accelerated growth in NGS. On Slide 10, as we noted on our Q2 call, Advanced Diagnostics revenue growth slowed in Q3, with an increase of 8% versus prior year. ADx revenue grew slower in the third quarter due to macroeconomic conditions, and pharma R&D spend, as well as our decision to rationalize our global testing sites and low margin business. This is expected to continue into the fourth quarter and early 2024. However, the focus on profitability and margin growth is driving performance with adjusted gross profit for ADx improving by $6.4 million, or 32%, and adjusted gross margins improving by 440 basis points on a year-to-date basis versus prior year. Looking at the income statement on Slide 11, adjusted gross margin was 44.2%, an improvement of 247 basis points over the third quarter of last year. Adjusted EBITDA was positive $3 million, up $15 million, or 129% improvement over the third quarter of 2022. These significant improvements were driven by both higher gross profit, and lower operating expenses, and highlight the operating leverage in the business. Regarding operating expenses, sales and marketing expense was $17.6 million as we continue to invest in the expansion of our sales force. G&A was $61.5 million and R&D expense was $5.3 million. We did have a favorable R&D tax credit related to fiscal year 2022, of $1 million in the quarter. In addition, there was $2.1 million in restructuring costs in the quarter, related to the previously announced organizational restructuring, and footprint optimization, which is part of our value capture program to gain operating leverage. We have revised our original restructuring plan cost and timing of projects, and as a result, now anticipate these costs extending into 2024. These charges will ultimately result in enhanced operational efficiencies, as we continue to optimize our geographic presence. Turning to the balance sheet on Slide 12, we ended the third quarter with cash and marketable securities of $402 million. We continue to make good progress in diligently managing our cash burn, and are focused on accountability and disciplined oversight of operating expenses. Cash flow from operations improved $11 million or 66% from Q3 2022. On a year-to-date basis, cash flow from operations improved by $43 million or 68%, and the year-to-date cash burn improved by $36 million or 50% over the first nine months of 2022. Our strong financial position provides us the financial flexibility to continue to invest in the business, and achieve our strategic and financial objectives. Given our Q3 financial performance, and continued progress executing on our strategic priorities, we are revising our revenue and adjusted EBITDA guidance for the year. Turning to Slide 14, we previously had revenues of $565 million to $575 million, representing 11% to 13% growth in 2023. We are revising that range upward, and now expect total revenue between $585 million and $592 million for the year, representing 15% to 16% growth. Adjusted EBITDA was negative $13 million to negative $10 million, and is now negative $4 million to negative $1 million, and at the midpoint represents an improvement of $46 million or 95% from year-end 2022. We continue to see strong revenue growth, and an increase in NGS product mix, and are very encouraged by the opportunities for RaDaR and other newly launched tests, which provide accelerated leverage to the bottom line. As we stated at the beginning of the year, our year-over-year comparisons will be more difficult in the fourth quarter, but we believe we have a strong foundation and dedicated teammates to deliver financial results. While we continue to be focused on driving operational efficiencies, we will also continue to invest in the business to capitalize on our future growth opportunities. Our strategic focus remains to deliver long-term sustainable growth. With that, I'll turn it back over to Chris.

Thanks, Jeff. As you can see, we're very pleased with our year-over-year progress, including strong revenue growth of 18% and significant improvement in adjusted EBITDA. We now have three pending submissions for RaDaR with MolDX, and we're generating additional data that will support expanded coverage in the future. We saw meaningful progress in the execution of our strategic priorities, and therefore are raising our guidance for the full year results. We are well on our way to becoming the leading cancer testing information decision support company. We'll continue to build on the foundation we have laid out over the past several quarters to deliver long-term sustainable growth. I'm excited for our teammates and our customers, but most of all, the patients that we get to serve on a daily basis. Thanks, and we'll turn it back over the operator to open the call up for questions.

Thank you. We will now begin the question-and-answer session. The first question comes from Mark Massaro with BTIT. Please go ahead.

Hey, Mark.

Hey, this is Vidyun filling in for Mark. Thank you for taking my questions and congratulations on a strong quarter. I'm curious about the key data points we should watch for regarding RaDaR from the twenty-seven clinical trials. Specifically, when can we expect to see a head-to-head comparison with a competitor's MRD test? Thank you.

Yeah. Why don't I let Vishal take that. He can talk a little bit about some of those key trials that we've got ongoing.

So, one of the trials will have some initial data coming out at San Antonio, which is the TRACER clinical trial. The other ones, we'll see data readouts throughout the year in 2024. In terms of head-to-head, that's still something that we are considering. It's not something that is a main focus for us. Our focus is developing our own clinical data, to get published and also to get MolDx approval.

Okay. Perfect. Yeah. And then, what levers could be pulled from here, with respect to operating leverage and OpEx management? Should we think about most of the improvement from here to be a dropdown on revenue growth, and what are some areas you might be looking to optimize from here on, taking out any additional cost, if any?

Yeah. I think as we've said in previous quarters, I think, from an operating leverage standpoint, we continue to see a lot of different opportunities that continue to drive results. We've seen good progress on the volume front this year, and continue to see opportunities to drive volume growth. We've seen good growth in pricing as we focus our attention on a higher complexity test. We've talked about NGS growth. It represents only about 25% of our total clinical revenue today, and it's growing much faster than the overall market growth. So, that area is going to drive performance as well. We continue to see opportunities to grow the ADx business, and we've talked about a few things for the margin perspective. Implementing a new LIMS system is going to help us be more efficient to drive more improvement on the adjusted gross margin line, better procurement, and systematic buying will also help us drive performance there. And then below the line on the OpEx side, we're continuing to look for opportunities to get more efficient there as well. You see our year-to-year OpEx expense is down year-to-year, both in the quarter, and on a year-to-date basis, and that's before even taking into account restructuring costs that we're hitting this year. So, I think as we think about our drivers, we see a lot of opportunity to continue to do what we've done this year, and we'll talk more about 2024 when we give our Q4 guidance in February, but we still see a lot of runway to drive improved performance.

Thanks.

John, can we move to the next question?

Absolutely. The next question comes from Andrew Brackman with William Blair. Please proceed.

Hey, Andrew.

Hi, guys. Good afternoon. Hey, Chris. How are you doing? Thanks for taking the questions. Maybe if I could start on the durability of growth for that revenue per test metric, can you maybe just sort of talk about how you're thinking about some of those drivers, or sort of some moderation in that rate over time? Just trying to figure out how much juice is left to squeeze, just from internal initiatives. Thanks.

So I'll hit it high level, but I'll let Jeff kind of walk through because there are like really three main levers, but I think, look, one of them, obviously, has been mixed around NGS, and this is the first quarter as you know, we've kind of come out and disclosed the growth on NGS, and the amount of revenue, and look, at being only 25% clinical revenue, it gives us lots of runway because of where the ASP is. And so that mix, we're able to continue to manage, especially as we expand the sales force, and continue to expand our presence with the oncologists versus just pathologists and hospitals. But, Jeff, do you want to kind of talk through the levers in the way because I know you, and the team, and Warren spend a lot of time there?

Yeah. If you go back to 2021 and 2022, our revenue per test was growing anywhere between 2% and 7%. We've clearly seen an uptick in 2023 with our revenue per test, with our NGS growth now averaging almost 10% for the year. So, I think we're going to continue to stay focused on growing NGS, and expect to continue to see growth over time in revenue per test. I'm not sure I would extrapolate 12% in one quarter over time, but I think we continue to expect to see growth. And then, I think there's two other areas that we have focused initiatives on. The first is our revenue cycle, just collecting more for the work we're currently doing. We've seen good improvements in that for the year, and I think we actually have a multi-year opportunity there. And then, the last area is just price. We are seeing price increases with our direct client bill contracts, and we're working on taking a more coordinated approach with our managed care pricing as well. And this is an area where we think dedicating some resources, and some talent is going to help drive our revenue. So, I think as we stand back, and look at we've had very strong growth this year, but we still see, I think, a multi-year opportunity to see revenue per test grow over time.

Yeah. So, I think from a durability perspective, we see that continuing to run for the next several years.

Okay. That's perfect. And then, appreciate you guys actually giving that color on sort of the NGS mix here. I wanted to ask on the non-NGS side, because I think by math, you guys put up growth, call it in the low-teens and mid-teens in the quarter. Can you maybe just talk about the durability of growth in that category as well, just as we look at those more traditional tests? Thanks.

I believe there are several factors influencing this situation. Firstly, we are currently experiencing more wins than losses, which has allowed us to gain market share and enhance our growth across different modalities. Generally, these modalities might see a growth rate of around 2% to 4%, but we are outperforming the market in every category. Additionally, our strategy around revenue cycle management benefits not only our NGS sector but also contributes positively across the board, boosting our revenue in all areas. We are witnessing impressive growth, and looking at the overall market, we see ample opportunity to increase our market share. Our strategy includes not only acquiring new accounts but also penetrating existing accounts where we don’t yet have a presence. Warren, do you have anything to add?

I think that probably the high level of Chris is that ultimately, it's commercial strategy that we're executing again. So, we're losing less than what we have in the past. That's the fundamental for us to build on.

And winning more.

Expanding share of wallet is much easier with existing customers, and we have been very effective in this area, which has likely driven our largest growth. Additionally, winning new customers is important as we've increased our sales resources. We believe many of the customers we've secured in 2023 will continue to grow in 2024, providing a positive boost as we head into next year. Ultimately, it is the effective execution of our strategy that is leading to above-market growth in other areas.

And then, I think, that we will clearly see a correlation between improved turnaround time and sales growth as well, so as our operational efficiencies continue to improve, it's helping us drive incremental volume.

Okay. That was great. Thanks, guys.

Thanks, Andrew.

The next question comes from Alex Nowak with Craig-Hallum. Alex, please proceed.

Hey, Alex.

Okay. Great. Good afternoon. Hey, good afternoon, everyone. Really strong NGS gains as we've talked about here so far in the call. The company lost market share in NGS, and the molecular business over the last couple of years, really, before the new team has joined. So, is this really taking back market share from those gains that were lost, or is this better penetration of NGS into your existing customers that maybe haven't used NGS to the full extent?

I would say yes, it's really both. The market is growing 15% to 20%, so when we're growing over 35%, we are not only keeping pace with the market but also gaining market share. It's really a combination of both.

Okay. Got it. And then the breast MolDx re-submission here, Is that going to be to grant a broader MRD and recurrence label versus the five-year recurrence label we have today?

Let me pass it over to Vishal to discuss what’s happening with our products at MolDX.

Yeah. So that is correct. It's going to be an expansion to our current approval that we have from MolDX, both in the recurrence and surveillance mix.

Very easy. Excellent. Thank you.

Thank you.

Up next, we have David Westenberg with Piper Sandler. David, please proceed.

Hey, David.

Hi. Thank you.

Thank you for taking my questions and congratulations on a strong quarter. I appreciate the discussion around the growth in NGS. The increase in ASP was significant, so I’d like to delve a bit deeper into the revenue cycle management aspect. If possible, could you help us understand the impact of that increase and how substantial it is in terms of revenue cycle management? Also, was there any one-time item in this quarter related to revenue cycle management that we should consider while modeling ASPs? I believe you exceeded expectations by around $40 this quarter. Yeah. Let me maybe take it a couple of ways, and let Jeff, kind of get into the details. So, we haven't disclosed how much the opportunity is, but when we build, the way we've thought about the business over the next several years, there's opportunity to continue to move that out. And, David, I think we may have even talked about this when we met in San Francisco, that being new to the industry, I am incredibly surprised that just general how bad the industry is getting paid for the work that we do. And I think, we believe that reimbursement, and billing should be a core competency of the company. So we're spending a lot of time, resources, and energy, I would say doing innovative things that we think will significantly improve our ability to get paid for what we do, but Jeff, do you want to give more...

Yeah. From an overall NGS perspective, look, I think roughly 60% plus of the revenue per test is driven by just NGS, mix and price within NGS, and then the balance would be revenue cycle initiatives, and other modalities that we're seeing growth in. And so, again, with that relatively low penetration percentage of our total clinical revenue, and our continued focus on driving that, we do see an opportunity to continue to drive that. Again, I wouldn't extrapolate one quarter, but we've got 10% revenue per test year to date, and it has clearly stepped up from where we've been, the previous eight to 10 quarters before that.

Got it. Just a quick thought on PAMA, if and when it returns, I would like to consider that for '24 and '25 in relation to our model. Thank you.

You want to take that, Warren?

Yeah. I mean, if and when it returns, I mean it's difficult to actually understand exactly how it will impact. Certainly, some of the lower value modalities is certainly where some of the cuts are isolated at the end of the day. As we look forward into the future, we don't see that has a material impact to job performance. Certainly, if it does materialize, it will be a marginal headwind to AUP, but nothing too material because it is with the lower value modalities that are in focus.

Thank you.

Thanks, David.

Okay. The next question comes from Tejas Savant with Morgan Stanley. Please proceed.

Hi, this is Madison Pasterchick for Tejas. Congratulations on a strong quarter. Regarding the guidance and its implications for the fourth quarter, could you provide some insight on why you consider flat sequential growth for the top line to be a reasonable expectation for the quarter? Also, is there any caution reflected in the guidance? What are your assumptions regarding budget fluctuations at the midpoint?

I missed part of your question. Could you repeat the last part? You were discussing the conservatism in the guidance, but I didn't catch everything you said.

Yeah. Just wondering what kind of conservatism is built into the guide for the fourth quarter, and if you're assuming kind of any budget flush, just looking at, it looks about flat sequentially from third quarter, fourth quarter, so trying to parse out some color there.

Yeah, I mean, the midpoint is roughly flat, but it is a range of performance for Q4. So, I wouldn't call on anything unusual in Q4. We expect to see, continued improvement as we have throughout the year, but clearly as we think about guiding for Q4, wanted to give a range that we thought made sense.

Got you. That makes sense. And anything you're assuming there on the budget flush?

The what?

Budget flush.

I'm not sure what you mean by budget flush.

Okay. Within biopharma.

I'm sorry?

Sorry, I don't know if…

Can you say that…

Yeah. I'll just move on to the next question.

Okay.

Just, can you talk a bit about any conversations you've been having with biopharma customers, feedback you've been getting from them? And I know you talked a bit about the tougher macroenvironment in ADx, so any color there you've been seeing?

Yeah. I can take that. So, we do hear from our pharma customers that there is consolidation in terms of the number of clinical trials that they're running, and the number of compounds that they're focusing on. A lot of it was earlier on in small biotech, but we're hearing this a little bit on the larger pharma companies also. So, based off that, I mean, that's why we saw a little bit of a slowdown in Q3 compared to the previous quarter, and we do expect it to continue a little bit going into Q4 and early 2024, but we're hearing consolidation, especially when it comes to the programs that they're focusing on, the limited number going into 2024.

And I think our broad menu of testing does help us…

It does.

Soften some of that impact, because we're not just focused on a couple of different single modalities.

It's a small percentage of indiscernible.

Yeah. We talked a lot about the importance of a portfolio effect. I mean, having informatics, and pharma, and RaDaR, and clinical, if one of those slows down a little bit in the quarter, even though you see good long-term opportunities, the others covered, and I think that's what you really saw here in the quarter.

Got you. That's really helpful. Thank you.

Thanks.

The next question is from Mike Matson with Needham. Mike, please proceed.

Hey, Mike.

Hey, everyone. Hey, this is Joseph on for Mike. Congrats on the quarter. Maybe just a couple around RaDaR, I'll try to just put this onto one, but for breast, looking just, at the expanded coverage, do you think that timeline could be a little bit quicker than the other two submissions, just given that you've already had dialogue with them in a previous submission? And then, just a reminder, I know you guys said it before, but under the current reimbursement profile for breast that you guys have, about what percentage of that potential MRD volume for breast cancer patients is there with that current reimbursement? And then, just looking at the other three submissions that you guys announced, can you maybe just talk about your confidence on those submissions, if you have enough evidence with those? I know you guys didn't necessarily get awarded for colorectal. You're looking at more evidence for that. Maybe could you put a timeline of, when you're expecting that submission, if it could be by the end of the year?

Okay. That's a lot of questions, a lot in one there.

Yeah, my bad.

Thank you for your question. We believe we will have a quicker timeline for the breast indication compared to what we experienced with colorectal. We have successfully pursued the initial breast indication, and we feel confident in our understanding of what is expected by MolDx. Currently, we haven't differentiated the number of minimal residual disease cases from breast cancer patients versus our existing submissions by cancer type. Our primary focus remains on breast cancer due to its high sensitivity and significant value proposition. Regarding our confidence in other submissions, including head and neck and lung, we have already submitted those. A key advantage we have with these submissions, which we did not have with colorectal, is strong publications that we believe will enhance patient care. We have incorporated those publications into our submissions. For colorectal cancer, we are looking at potential developments in 2024 rather than this year. I believe that covers everything.

Thanks. That was great. I'll ask one more quick question about RaDaR. Looking ahead to 2024, it seems possible that RaDaR could be used clinically for various cancers. Could you provide some insight into the potential gross margins for those tests? Specifically, what are the expectations for both high and low gross margin improvements as these tests begin to roll out in a clinical setting?

I appreciate your attempt to ask that question, but we haven't provided guidance for 2024. It's still early with RaDaR. We believe it’s essential to ensure coverage, which involves running the right clinical trials and publishing the results. This is the first time we've publicly discussed the number of ongoing clinical trials related to RaDaR, indicating there's a lot happening. As we make progress, we will keep you updated, but we are not providing any financial guidance regarding gross margins or anything else related to RaDaR for next year.

Okay. Sure. Fair enough. Well, congrats on the great quarter you guys.

Thank you.

The next question comes from Tom Stevens with TD Cowen. Tom, please proceed.

Hey, all. Massive quarter, congratulations. I had sort of quick one, again, just to kind of beat the dead horse on your kind of CGP portfolio and kind of just where you're winning there. I mean, you talked about operational efficiency, you talked about more specialist sales force. Is it as simple as fast turnaround times, and being in front of conditions, or is it something more going on?

There are several factors at play. Many of these align with our sales optimization strategy and our priorities. We began adding field personnel late last year and continued to do so this year, specifically focusing on community oncologists, as we have previously concentrated on pathologists in hospitals. This shift is definitely having an effect. Prior to our product launch in March, we were not a significant player in the solid tumor space, and it takes time for a new product to gain traction. We remain a leader in hematology and continue to introduce new innovations in that area. So, there are multiple elements involved, but perhaps Warren can provide further details.

I think the multiples things is exactly. It's a number of things acting in concert, and I think one of the first things I want to call out is the work we've done operationally from a turnaround time perspective, and we spoke about that in the call, but, obviously, with the importance of the NGS to overall performance, we give that extra focus, and we've done really well there from a turnaround time. I think the added resources in the field is the second factor here that's really contributing to the success. And then, thirdly, it's the execution of the sales strategy I spoke about earlier, coupled with new products that we brought to market not only the CGP panel that we brought to market in March of this year, but also the new heme, the Neo Comprehensive that we launched earlier in quarter three. Those are all contributing. Just a number of factors and concepts that are sort of compounding on now that's driving the performance.

Wonderful. Yeah. So, I guess, I'll follow up with a two-parter there. I guess, just on the back of that, going into next year, should we expect these kinds of growth rates going into '24 within the NGS portfolio, given the number of launches in the sequence you've had this year? And then, just the second one, a bit unrelated is kind of, have you guys thought about, or outlined kind of the net gross margin benefit you get from this LIMS reorg?

Internally, we have undertaken a significant project with the Laboratory Information Management System (LIMS). The planning process took several months to reach a satisfactory state. We have separated this initiative from the business and dedicated specific resources to ensure focused execution. However, having completed five acquisitions throughout the company's history and operating on multiple LIMS systems has created considerable inefficiencies from a gross margin standpoint. Implementing one of these systems is similar to an ERP project and requires a significant amount of time, so we do not expect to see immediate results starting January 1. We anticipate some positive effects beginning in the first half of 2024, but we believe the full impact will unfold over a two-year period, continuing to improve over time.

And then…

Do you want to add anything else?

Just on the NGS growth, look, we continue to expect NGS is going to grow next year, but we'll give more color on that as we give our guidance going into next year.

Wonderful. Congrats on the quarter. I'll get back in the queue.

Thank you.

Thanks.

Up next, we have Matthew Sykes with Goldman Sachs. Matthew, please proceed.

Hey, Matt.

Hey, everyone. This is Prashant Kota filling in for Matt. Congratulations on the quarter, and thank you for taking my question. Could you provide clarification on the additional breast MRD submission? I know it's been discussed, but is it specifically for triple-negative breast cancer?

Hey, Matt. Yeah, it is for triple-negative breast cancer.

Got it. Okay. Thank you. And then, how much market share do you see RaDaR capturing over the longer term, given the competitive landscape?

Well, look, I think the way to think about it, a lot of you all, right, the market, the analysts have been writing that it's a $20 billion market, and less than 1% or 2% penetrated. So, there's a lot of lot of runway. I mean, obviously, there's a company in front of us, there's multiple companies coming out, but, look, I would not say that we're publicly disclosing, with the shares. I would say, look, what we're seeing is our sensitivity is significant, and we're seeing that really makes a difference in disease cancer states where sensitivity matters, places like breast, lung, etc. So, I think it's just too early to try to speculate how the share will all wake up, but look, big, big market with lots of opportunity.

Got it. And just lastly, any color on the sales force expansion?

Yeah. So we've continued to expand our sales force in the latter part of Q3 and into Q4. A lot of the work we're doing in full transparency really culminates into the sort of redeployment that we're kicking off very early in 2024 that will position us to continue the momentum that we've experienced in 2023 thus far.

Got it. Thanks, guys.

The next question comes from Mason Carrico from Stephens. Please proceed.

Hey, guys. This is Jacob on for Mason. Thanks for taking the question. Congrats on a strong print. So, I appreciate all the color on the NGS growth, lot's been covered there, but maybe just taking a little bit deeper in there, could you talk about how the growth trended during the quarter in NGS across heme versus solid tumor?

We combined all our NGS results, so we don’t separate how much is heme or solid. We've indicated publicly that we haven't been active in solid tumors until we launched our new panel in March, but we don't share the breakdown of heme versus solid.

And we don't really talk about inter-quarter performance either.

Yeah.

So, we'd prefer to just talk about in quarterly increments.

Okay. Yeah. Thanks for that. So…

It's really our competitive reasons. It's not that we don't want to give any color, but look, it's a highly competitive place, and I think we're really pleased with where things are going, and we just from a competitive perspective, don't disclose that.

Yeah. No, that makes sense. So on that new test you launched, Neo Comprehensive, it's been out there in the market for a little bit now. Could you maybe talk about how adoption trended, and maybe more specifically, do you think you're converting docs away from competing offerings that have been on the market for a little bit, or do you think the majority of the growth is just coming from broader market expansion?

Yeah. It's a combination of both. There are certainly many cases that we could cite where there's been conversions that we've managed to accomplish, and in other cases we had broader market expansion because of the growth in the market that we're actually benefiting from. So, it's a combination of both. And yeah, I reiterate the fact that the investment from the sales team spectrum is really what's helping heme.

I think that's been very beneficial. One of the strengths of Neo has always been the community setting. Consider the community oncologists; many of our competitors are primarily based in universities or research institutions. Therefore, our ability to further penetrate the community oncologist market is crucial for our growth. A significant number of treatments are taking place in the community.

Got it. And then, if I can just squeeze in one final one here, on your commercial sales team, you talked about how you're continuing to expand in Q3 and Q4, but I think you previously mentioned that you really don't plan on materially scaling that team in 2024. Is that still the plan, or have your thoughts changed there?

I believe that most of our investments for commercial expansion will occur towards the end of this year, with some possibly extending into the first quarter. This is all part of our broader strategy for 2024. We're focusing our resources on customer interaction while also investing in back-office functions to enhance enablement. This is crucial for driving productivity improvements within the sales team, enabling us to achieve more with our current team. This should help reduce the necessity for additional investments in 2024, but we will reassess our plans for 2025 around this time next year.

All right. That makes sense. Thanks, guys.

Thank you.

The next question comes from Puneet Souda with Leerink Partners. Please proceed.

Yeah. Hi, guys. Hey, Chris, thanks for taking the question. So maybe at a high level, and apologize if this was covered, but I wanted to get your view on the revenue cycle management has been a big focus. Obviously, you're seeing improvement here in AUP that is remarkable. So maybe can you talk about where you are in that revenue cycle management transformation process, how far it's done, and sort of what's left to go? Maybe just talk about that at a high level if you could?

I appreciate the busy day with the markets closed. We touched on some of these points earlier, but we can certainly revisit them. One key area we've discussed is our mix, particularly with NGS contributing 20% to 25% of our clinical revenue, which offers significant growth potential. Additionally, there are aspects that Jeff elaborated on regarding other strategies. We view revenue cycle management as a multi-year initiative, and I'd like to hear your thoughts on it.

I would say we're still in the early phases of capitalizing on the opportunity and revenue side, Puneet. And what I said earlier on the call was, roughly about 60% plus of our improvement in revenue per test was driven by NGS mix, and the balance was pricing, revenue cycle improvements, and some mix in our other testing volume. But as we think about what we're expecting to get paid, and what we are getting paid, we still see room to improve there, and it's not a one quarter or two-quarter process. I think it's a multi-quarter process. We want to use technology more efficiently to make sure we're being efficient, making sure we're getting prior authorizations, making sure that we have a medical necessity covered, medical records covered. So, there's a lot of different drivers, and frankly, varies by payer, where the opportunity exists, but I think we have a good handle on where we're not being paid, and have plans in place to close that gap.

Do you want to talk a little bit about contracting? We have like 200 payer contracts, but how'd you talk to managed care runway?

Managed care was another area of focus for us. We have a pricing strategy through our direct line bill, which accounts for about 65% of our clinical revenue. The remaining third comes from managed care contracting, and we have enhanced our resources to pursue pricing improvements in a more coordinated and sophisticated manner within our managed care operations. This approach is multifaceted, and we believe there is still significant potential for growth in this area over the next couple of years.

Got it. Thanks for all the insights. One more thing, labor inflation was a concern early on, and the cost of goods remains a worry for some labs. Could you discuss the overall labor costs and inflation you are experiencing? Do you think the layoffs in the biotech and diagnostics sectors might present you with opportunities in the hiring landscape to address these market concerns? Thank you.

I believe some companies have overextended themselves financially, which makes us more vigilant in seeking out excellent team members. Our people are our most valuable asset, so we always look to enhance that aspect. Additionally, our diverse locations, including wet labs in Houston, Orange County, Fort Myers, and Raleigh, provide us with access to strong labor pools, which helps us attract and retain top talent. Consequently, we haven’t experienced a significant impact. We are committed to hiring the best and compensating them fairly, but overall, we’ve managed to navigate this without major disruptions. Recently, we've recognized that Neo didn’t focus much on purchasing and procurement, leading us to spend substantial sums. In response to this, we appointed a chief procurement officer and implemented systems designed to improve our management of purchasing within the business.

Got it. Okay. Super. I think all the RaDaR questions are covered, so I'm good. Thank you.

All right. Thanks so much.

Okay. We have reached the end of the question-and-answer session. I will now turn the call over to management for any closing remarks.

Okay. So for the folks, who are still on, look, we really appreciate you taking the time. It was a busy day in our sector, and the market, so thanks for hanging in there with us and learning a little bit about what happened in the Q3, and look, we'll look forward to coming back to you with the Q4 results sometime after the first year. Until then, take care.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.