NeoGenomics, Inc. (NASDAQ:NEO) reported a 14% increase in revenue to $156 million for the first quarter of 2024, fueled by a 17% rise in clinical services revenue. The company's adjusted EBITDA saw a significant increase of 149% to $3 million. Despite a 3% decline in advanced diagnostics revenue due to macroeconomic conditions, the company's adjusted gross profit and margin saw improvements. NeoGenomics maintains its full-year revenue guidance of $650 million to $660 million and aims to be at the higher end of the adjusted EBITDA range of $21 million to $24 million. The company is preparing to retire its 2025 convertible notes using its cash reserves and marketable securities, which stood at $385 million at the end of the quarter.
Key Takeaways
- Revenue rose to $156 million, a 14% increase, with clinical services revenue up by 17%.
- Adjusted EBITDA soared by 149% to reach $3 million.
- Gross profit improved by 19% to $71 million.
- Full-year revenue guidance reiterated at $650 million to $660 million.
- Plans to retire 2025 convertible notes using the current cash balance.
- Advanced diagnostics revenue declined by 3% due to external economic factors.
- Operating expenses rose due to legal and lab closure costs.
- Cash flow from operations decreased by $13 million.
Company Outlook
- NeoGenomics expects revenue flow to remain consistent in Q2 and Q3, with a stronger Q4.
- The company is focusing on profitably growing its core business and accelerating advanced diagnostics.
- Investment in R&D and quality programs to drive innovation and improve products and services is ongoing.
Bearish Highlights
- Advanced diagnostics revenue saw a 3% decline influenced by macroeconomic conditions.
- Operating expenses increased, primarily due to legal costs and lab closure costs.
- Cash flow from operations saw a decrease of $13 million.
Bullish Highlights
- NeoGenomics is optimistic about the FDA's final ruling on lab developed tests.
- The company plans to launch new products, including a liquid biopsy test.
- There is strong growth potential in hospitals and community oncology for the Neo Comprehensive product line.
- NeoGenomics is investing in digital pathology and evaluating MRD testing options.
Misses
- The company has yet to find a comprehensive solution for digital pathology.
- Reimbursement issues remain a challenge for MRD testing.
Q&A Highlights
- NeoGenomics is evaluating strategic M&A opportunities.
- The company is awaiting a decision on its appeal in a patent litigation case.
- There is a focus on operational efficiencies and cost savings initiatives.
- The sales force has expanded, targeting community oncology and traditional call points in hospitals.
NeoGenomics' first quarter of 2024 demonstrates the company's resilience and strategic focus on growth despite some challenges in the advanced diagnostics sector. With a strong cash position and a clear vision for the future, NeoGenomics is positioning itself to capitalize on the evolving diagnostics market.
InvestingPro Insights
NeoGenomics, Inc. (NEO) continues to navigate the diagnostics market with strategic growth initiatives, as evidenced by the reported 14% revenue increase in Q1 2024. To further understand the company's financial health and future prospects, let's delve into some key metrics and insights from InvestingPro.
InvestingPro Data reveals a market capitalization of $1780 million, indicating the company's size and investor valuation in the market. Despite not being profitable over the last twelve months, NEO's revenue growth remained positive at 16.07% as of the last twelve months ending Q4 2023, showcasing its ability to expand its top-line revenue. This is particularly relevant as the company aims to be at the higher end of its adjusted EBITDA guidance.
Among the InvestingPro Tips, analysts have revised their earnings upwards for the upcoming period, reflecting optimism in NeoGenomics' financial outlook. Additionally, the company's liquid assets exceed short-term obligations, suggesting a healthy liquidity position to manage its immediate financial responsibilities, such as the retirement of its 2025 convertible notes.
For readers seeking additional insights and detailed analysis, InvestingPro offers more tips that can guide investment decisions. With the use of the coupon code PRONEWS24, users can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are currently 6 additional InvestingPro Tips available for NeoGenomics, which can provide a deeper understanding of the company's financial metrics and market position.
As NeoGenomics looks to the future with plans for new product launches and potential strategic M&A opportunities, these InvestingPro insights can help investors keep a close eye on the company's performance and potential in the diagnostics sector.
Full transcript - NeoGenomics Inc (NEO) Q1 2024:
Operator: Welcome to the NeoGenomics First Quarter 2024 Financial Results Conference Call and Webcast. 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.
Kendra Sweeney: Thank you, Holly. Good morning, everyone, and welcome to the NeoGenomics first quarter 2024 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 Warren Stone, Chief Commercial Officer; Melody Harris, Chief Operations Officer and President of Informatics; and Ali Olivo, Executive Vice President, General Counsel and Business Development. 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 company. Any non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measures in a table available in the press release we issued this morning. I will now turn the call over to Chris Smith, Chief Executive Officer of NeoGenomics.
Chris Smith: Thanks Kendra, and welcome everyone. Thanks for joining us this morning to go through our first quarter financial results. As always, I want to begin with our mission and vision statements 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. And before we get into the financial results, I just want to thank our teammates for everything they do every single day to make a difference in so many patients lives. Now let's move to Slide 4 and get into the first quarter highlights. As you can see, we delivered another quarter of strong revenue growth, growing 14% over prior year to $156 million. Clinical services revenue increased 17% to $135 million, primarily driven by execution of the commercial strategy and increased adoption of our NGS products. The compounding effect of volume and revenue cycle management initiatives, including an AUP lift, enabled NGS growth of over 50% and now is approaching 30% of our total clinical revenue. As growth rates accelerate and NGS becomes a larger portion of our base business, the comparables will become tougher as the year progresses. Advanced diagnostics revenue declined by 3% over prior year, in part due to macro conditions in the pharma sector and margin optimization initiatives from 2023. As a business adjusted gross profit was up 19% to $71 million and adjusted EBITDA improved 149%, or $11 million over Q1 of last year to a positive $3 million. Now on Slide 5. I'm very pleased that the first quarter continued the trend we've seen since the fourth quarter of 2022 of consistent year-over-year improvements in revenue, adjusted gross profit and adjusted EBITDA. This is especially noteworthy as we did not see the typical industry seasonality in Q1, with total revenue actually increasing sequentially from the fourth quarter. We believe that we've laid a solid foundation for growth in 2023 and expect that momentum will continue as we move forward. Let's move on to Slide 6. On our full year 2023 call, we laid out our strategic priorities for 2024. They included profitably growing the core business, accelerating advanced diagnostics, driving value creation and enhancing our people and culture. Our people are our greatest asset and we are devoting time and resources to enhance teammate development and engagement. Everything we do internally is centered around developing a customer-oriented and growth mindset and our teammates show each day their dedication to improving patient care. This morning, though, I'm going to focus on our three financial priorities. As we continue to profitably grow our core clinical business as we execute on our commercial strategy, which is protect, expand, acquire. This has contributed to our strong volume growth, increased AUP and improved mix. The mixed shift towards higher value modalities and tests that supported the delivery of yet another quarterly improvement in revenue per test. Even with the focus on growing NGS, we continue to see growth in clinical volumes across all modalities. To win in oncology, we have the breadth of menu and the products that deliver value in real-world clinical settings through high quality, actionable, differentiated tests that help support treatment decisions as well as best in class, customer focused mindset. Earlier this month, we announced senior leadership promotions as part of our ongoing efforts to optimize our operating structure. Warren Stone is now NEO's Chief Commercial Officer and will lead our clinical and pharma service commercial teams. Melody Harris is now NEO's Chief Operations Officer and President of Informatics and will oversee data-oriented teams and continue to manage all enterprise operations. Warren and Melody have shown exceptional leadership and performance in their roles, and I'm confident their new responsibilities will strengthen commercial synergies and drive growth as well as improving operating efficiencies. As a result of these changes, the legacy pharma business is now reporting to Warren. Informatics is now under Melody's leadership. And R&D will be reporting to me. We remain focused on R&D as we believe innovation is a turbocharger for growth. Specifically, we're committed to offering an MRD product to patients and healthcare providers, and we believe we have several viable pathways to accomplish that. As we noted over the past several quarters, macro trends as well as operational challenges continue to impact our pharma revenue, building on the strength and our go-to-market strategy seen in our clinical business. We are integrating the pharma commercial organization under Warren's leadership to leverage the success and the commercial execution seen in the clinical business. We are expanding our pharma sales organization as it moves under Warren's leadership and expect to see benefits from it's initiative in the future. In addition, our margin optimization efforts in ADx have continued to improve adjusted gross margin performance. Informatics revenue continues to grow as we drive increased investment and look to expand product offerings. We continue to focus on the acceleration of innovation in R&D, including the launch of a new liquid biopsy comprehensive genomic profile test expected in late 2024. Additionally, building on the success of the NEO comprehensive 1.0, we are focusing on the development of our next generation broad solid tumor panel, which is targeted to be one of the largest solid tumor CGP panels on the market. While providing industry leading turnaround times. We believe this new large NGS panel will provide additional growth opportunities in clinical pharma and the informatics space. We remain focused on driving value creation from a financial perspective. In late 2023, we kicked off our LIMS project that will consolidate fragmented systems into one end-to-end solution, which will serve as the foundation for our digital transformation strategy. While enhancing operating efficiencies. We are driving gross margin expansion through investing in automation and lab and supply chain optimization. We also continue to invest in our quality programs to improve our products and services, as well as to prepare the company for increasing regulatory oversight. Yesterday, the FDA released its final ruling regarding regulation of lab developed tests. Our initial view is that the rule is favorable to our business. The rule significantly expands LTTS that would not be required to get pre-market approval from the FDA, including tests marketed before May 6, 2024 and those approved by the New York State. This enforcement discretion is favorable to our broad test menu and should reduce the anticipated cost of compliance. We've been preparing for the increasing regulation and we believe we're well positioned to comply with the rule. From a legal perspective, we are vigorously defending our RaDaR technology. A hearing to appeal the preliminary injunction against RaDaR was held on March 29th in the Federal Circuit Court and we are awaiting that outcome. The North Carolina District court case is currently in discovery and the jury trial is scheduled for March of 2025. We have also filed IPR petitions with the U.S. Patent and Trademark Office seeking to determine that Natera (NASDAQ:NTRA)'s two patents at issue are unpatentable in the view of prior art. With that, I will now turn the call over to Jeff to review our first quarter financial results in more detail. Jeff?
Jeff Sherman: Thanks Chris, and good morning, everyone. I'll begin with a little more detail on our operating results for the quarter. As Chris said, we started the year with revenue experiencing double-digit growth over prior year. First quarter revenue was $156 million, a 14% increase over the prior year and higher than the fourth quarter of 2023. Revenue growth was driven by growth in clinical test volume, a continuing shift to higher value tests, and improvement in revenue per test driven by business mix and revenue cycle improvements. Adjusted EBITDA improved to 149% from prior year to positive $3 million. Q1 marks the sixth consecutive quarter that adjusted EBITDA increased from prior year as we continue to generate significant operating leverage on our revenue growth. Looking at Slide 8, clinical services revenue of $135 million was an increase of 17% over prior year, driven by an 11% improvement in revenue per test and a 5% increase in volume. The optimization of our sales force along with the increased adoption of our NGS products continues to drive higher volume growth. NGS growth continues to be strong and is helping to drive revenue growth and earnings. Turning to Slide 9. Average revenue per clinical test increased by 11% over prior year to $447, the third consecutive quarter of double-digit growth and represents an improvement for the 12th consecutive quarter, as we maintain our focus on higher value tests and revenue cycle management initiatives. As we shared with you in the past, NGS is a strategic priority and is approaching 30% of our total clinical revenue. The focused efforts of our sales team to penetrate new and existing oncology accounts and drive adoption of our higher value NGS portfolio accelerated NGS revenue growth. Turning to Slide 10, advanced diagnostics revenue declined 3% over the prior year in Q1 as a result of macroeconomic conditions in pharma and R&D spend as well as a continuation of 2023 decisions to rationalize our global testing sites and low margin contracts. The focus on profitability and margin growth is driving performance in ADx, with adjusted gross profit and gross margins increasing versus the prior year. Looking at the income statement on Slide 11, adjusted gross profit increased by 18.6% over prior year and adjusted gross margin was 45.3%, an improvement of 180 basis points over the first quarter of last year. Regarding operating expenses, sales and marketing expense was $20 million, as we continue to increase our commercial investment and R&D expense was $7.6 million. G&A expense increased by $4.2 million over prior year, primarily driven by legal costs associated with the ongoing Natera litigation and costs related to the closure of the lab in La Jolla, California. The ongoing cost for this litigation as well as the costs related to the lab closure are being added back to adjusted EBITDA as non-recurring items in the quarter. Turning to the balance sheet on Slide 12, we ended the first quarter with cash and marketable securities of $385 million. Cash flow from operations decreased by $13 million in Q1 over prior year. The first quarter is typically the largest use of cash quarter when annual bonuses are paid. In addition, cash collections were impacted by approximately $5 million in the quarter due to the Change Healthcare (NASDAQ:CHNG) data breach as our hospital and payer clients struggled to manage their claims, adjudication and payments, we have started to recover some of this collection shortfall in the second quarter. Our strong cash position gives us the financial flexibility to address our 2025 convertible notes, with the principal balance of $201 million maturing in May 2025, these notes will become current liabilities on our balance sheet in the second quarter. Given our liquidity profile, our current expectation is to use our existing cash and marketable securities to retire the 2025 convertible notes when they mature. However, we are starting to evaluate strategic M&A opportunities which could ultimately impact our capital structure decisions. Now turning to our 2024 financial expectations on Slide 13, we are reiterating full year revenue guidance of $650 million to $660 million, representing 10% to 12% growth, and expect to be at the high end of the adjusted EBITDA range of $21 million to $24 million. In summary, Q1 continues the revenue margin improvement and earnings growth from 2023 and positions us well to achieve our goals for the year. I will now turn it back to Chris for his closing remarks.
Chris Smith: Thanks Jeff. I'm very proud of our team's first quarter progress, including strong revenue growth and significant improvement in adjusted EBITDA. In addition, we saw meaningful progress in the execution on our strategic priorities. We believe we're well on our way to becoming the leading cancer testing information and decision support company. The investments we have made in our teammates, labs, commercial organization, and R&D position us well to execute through the next stage of our growth. And while it's still early days, we believe the initial read on the FDA final rule is favorable to our business. I'm excited for our teammates and our customers, but most of all, for the patients we serve on a daily basis. Thanks for your time. And we'll now open up for questions.
Operator: [Operator Instructions] Your first question for today is from Mark Massaro with BTIG.
Chris Smith: Hi Mark.
Mark Massaro: Hi, guys. Hi, Chris. Congrats on a strong quarter in Q1. So I heard some interesting commentary about, I think, that you're starting to evaluate M&A opportunities. And then I heard that you're planning to participate in the MRD market one way or another, if those are my words, not yours. But can you just give us a sense for maybe your confidence about RaDaR litigation? And then can you speak to maybe the types of things you're looking at? Are you looking at partnerships or potential all-out acquisitions? And just give us a sense for what you're seeing in the marketplace. It appears to me that valuations are pretty depressed. So maybe an outright acquisition could make some sense.
Chris Smith: Yes, Mark. I'm going to hit a high level, and then I'll let Ali kind of take it, because she is our General Counsel but also leads BD. So she can hit it. But look, I think all along we talked about that the first 12 to 18 months, we're going to be very internally focused on getting the house back in order, and starting to put wins on the board. And that really to us, is really delivering double-digit growth and improving the operating earnings at a faster rate. And that's gone incredibly well. I think that now being said, we believe there's some interesting opportunities that we think strategically would help our mission and kind of the vision for the company to grow. And so Ali took on the role of BD beginning of the year. We've hired, we've brought on, built out a team there just to start to explore those. So I think, we definitely see that as an opportunity because we really think we're very uniquely positioned to kind of lead this oncology diagnostics testing business, right, from a reference perspective. But Ali, do you want to talk a little bit more about BD, and then just touch on how we're feeling about the legal amendment to RaDaR?
Ali Olivo: Sure. So I guess we'll start backwards. So there's three pathways that we kind of alluded to in our prepared remarks. One, is obviously the litigation. And we see that via the district court matter, as well as our IPRs that were filed against both patents that are asserted by Natera. The other is certainly with our R&D activity and our continued development of tests, including MRD tests. And then the third being in M&A. And that could take many forms. It can, you're right, valuations are depressed. It could take full acquisition. It could also be tech transfer, licensing, all of these things. And so all of these pathways are viable, and we're evaluating all of them.
Mark Massaro: Okay. Great. I'll keep my question to one.
Chris Smith: Thanks, Mark.
Operator: Your next question is from Puneet Souda with Leerink Partners.
Chris Smith: Hi Puneet.
Puneet Souda: Hi, Chris. Hi, Chris. Hi, thanks for taking my questions. So, just one on the clinical beat that you had. It's really great to see AUP continues to work, so congrats there. But you came in $7 million ahead of us and the street number, I believe, as well. But you're not raising the full year guide. So just wondering, where's the moderation? Is it on the pharma business or on the clinical side? I know you talked about a weaker pharma environment. Obviously, we're seeing that on the pharma side. But just wondering what, are some things that we ought to consider?
Chris Smith: Yes, I'm going to let Jeff kind of hit it, getting into the detail. But look, at a high level, you did hear me talk about not only kind of the macro issues in pharma, but also kind of some operational challenges in that business. And look - I would say from a strategic perspective, bringing Warren over to lead that business, and I think some of the strategies that we've implemented in clinical around sales force optimization, and our go-to-market have worked significantly well. And, Warren grew up a lot in the pharma business, key roles at Millipore and being able to call on that. And so, we think that's going to make a difference in the back half of the year. But as far as specific guidance, let me let Jeff kind of comment.
Jeff Sherman: Yes, sure. Thanks, Chris. Yes. So, Puneet, I think as we looked at guidance, we're only a couple months out from giving our annual guidance. I would remind everyone when we started the year, our initial guidance was over $20 million higher than consensus when we started the year. And as we looked at our Q1 performance, we were about $6 million ahead of consensus in Q1. So we had a strong Q1 from an execution standpoint. We did not see the typical seasonal slowdown in clinical that we've seen in prior years. So I think that's a testament, to our commercial teams and the execution we've seen, particularly on the NGS growth side. But we also have just put the pharma commercial sales team under Warren. So, we do want to give Warren a little time to get his arms around it and look at the business. We have been adding, sales reps there as well. So I think more of our expectation is ADx has been a challenge over the last couple of quarters, as well as what's happened in the overall macro situation. So, we want to give Warren time to get his arms around the business. And we'll look how performance happens in Q2, and we'll reevaluate guidance as we exit the second quarter.
Puneet Souda: Got it. That's helpful. And then just a quick follow-up on the FDA LDT rule. I mean, thanks for your comments, and it's great to see the majority of the portfolio is protected here, despite the rule. When you, Chris, when you think about the next round of tests and the products yet to be launched, for those to go through the FDA approval process, how are you thinking about the cost? Do you think it raises the cost for those, even though that process is over the next, three to four years? And maybe just talk to us at a high level, how do you see this FDA LDT regulation implementation playing out?
Chris Smith: Yes. So look, I think it's, I think the ruling was very favorable. I'll start by saying that. I think also just to say that, look, we're a board member at ACLA, and we're kind of aligned that we don't believe it's medical devices. And so, we'll see how that unfolds. But as far as cost and the impact of the business, one of the things that we did as a leadership team is everybody that we brought on has come from a regulated FDA environment. So the person that runs QRC grew up in only FDA regulated. So, we started probably 18 months ago of putting the systems in place, including design control and new products. And so, we've been going through that process. We've got two key products that are under development now that are kind of running through that process. And so, while there's definitely going to be costs associated with it, we believe we can manage it in the day-to-day business. There won't be a significant change to our outlook, or our forecast to be able to manage that business.
Puneet Souda: Got it. Super. Okay. Thank you.
Operator: Your next question for today is from Dan Brennan with TD Cowen.
Chris Smith: Hi Dan.
Dan Brennan: Hi, thanks for the question. Sorry about that. Hi, guys, can you speak a little bit just to the core clinical business? Just wondering, ex-NGS, kind of, what you guys saw in the quarter, looks like the results are okay there. And kind of how you're thinking about the progression of maybe volume, and price as we look out in the Q2 and beyond?
Chris Smith: Yes, look, I mean, I did mention in our prepared remarks that we did grow in all modalities, but Warren's here. So maybe I can let Warren kind of give you the high level piece of it. And then maybe Jeff kind of around more specifics in the detail. Do you want to?
Warren Stone: Yes, certainly. Thanks. Thanks, Chris. Dan, good morning. Q1 was a strong quarter, across all modalities, as Chris said. And from our data, we feel that we continue to grow from a volume perspective above market across all modalities. And that really speaks to our sort of account penetration strategy that, we have from a commercial perspective. Yes, we over-index on NGS, because of the relative importance of that. But the overarching sales strategy does target on sort of account ownership. And we're seeing the benefits of that through all of our modalities. And we feel based on the fact that it's sort of broad-based across multiple customers, and across the geography of the United States that it should be sustainable.
Jeff Sherman: Yes, and I think I would expect a similar kind of flow of revenue, Dan, from a quarterly perspective. Q1 is generally our softest quarter, tends to ramp, and Q2 and Q3, are in a similar range. And then we finish the year stronger in Q4. So, I would expect a similar sequencing of clinical performance this year.
Chris Smith: Yes, and I guess the last thing on that, Dan, remember we went through a field expansion where probably over an 18-month period, we doubled the size of our field organization. And so, I think what you see in this business, it really does take six to nine months of time and grade, to get flowing from a sales perspective, whether it's new products, new processes, new customers, new business. And so, I think we're starting to see the benefit of that, and to a point where I think it's something we've got to continue to evaluate, is kind of what we call feet on the street and making sure that we have the right amount of coverage, because we believe the opportunity is significant. And so it's about capturing it.
Dan Brennan: And then maybe just one follow-up, just on the sequencing side. So the liquid test, so is anything baked into the guide for that? I know you said it's later in '23. Like is that a fourth quarter event? Is it just any more color on kind of what the impact of that being, from a timing perspective? Thank you.
Chris Smith: Not expecting any material revenue from that in this year, Dan.
Jeff Sherman: Yes, it's late in the year.
Dan Brennan: Okay. All right. Great, guys. Thank you.
Chris Smith: Thanks. Take care.
Operator: The next question is from Andrew Brackman with William Blair.
Chris Smith: Hi, Andrew.
Andrew Brackman: Good morning. Thanks for taking the question. Hi Chris. Maybe on Neo Comprehensive, I think it's been just over a year since you launched that product. Can you maybe just give us a sense of the scale for that business, and that product line? And I guess just related to that, any color you can provide on sort of success rate, with cross-selling initiatives, or sort of - what accounts you're really seeing a lot of uptake in? Thanks.
Chris Smith: Yes, Andrew, I'll take it high level, then I'm going to let Warren kind of get into detail to it. But remember, we've talked a lot about this, that from a team perspective, we're a market leader in NGS. But from a solid tumor, we would have very low double-digit share. So, we knew that when we launched kind of that product. But let me maybe have Warren give more.
Warren Stone: Yes, just the correction there for Chris. We have low single-digit share in solid tumors. You said double-digit.
Chris Smith: I am so sorry. No I thought I've mistaken.
Warren Stone: So yes, and one of the reasons why we had low single-digit share in solid tumor, is the fact that we didn't have this board CGP panel. And as you correctly pointed out, we launched this in late March of last year. And we've done an upgrade on the product as well. Our penetration continues to evolve very, very favorably. We see it coming across in two areas. Obviously, our area of strength lies within the hospitals. And we're tapping into that opportunity. And we estimate sort of 20% of the market potential, comes from the hospital side of things. And the balance of the opportunity is in the community oncologist. Sometimes they're independent. Sometimes they're affiliated. But that's where we have a lot of opportunity to grow in the community oncology space, because we are largely underpenetrated for lack of a portfolio. We see robust growth quarter-over-quarter in terms of volume within that space as well. And ultimately, this is one of the leading drivers as to the 50% growth in NGS. We spoke about earlier today.
Andrew Brackman: Great. Thanks, guys.
Operator: Your next question for today is from Tejas Savant with Morgan Stanley.
Tejas Savant: Hi, guys. Good morning. So maybe just to kick things off, Chris, you raised your long-term targets to north of 10% on the last earnings call. Three years out, where do you expect NGS test mix to be in terms of your clinical revenue? It's about 25% today. Just given the growth you're seeing here, is there a scenario in your mind where over the course of those long-term targets, NGS mix could essentially be approaching 50% on an ex MRD basis?
Chris Smith: Well look, I think when you think of it, Tejas, and you talk about it over the timeline that you mentioned, we will be launching other products along the way. So for example, we're really excited about this liquid product that we're going to be launching. So, there'll be new products that will come in. But without question, we believe we have a ton of runway on NGS. I mean, I think, all the data that we see is that NGS market is probably only penetrated 30% to 40% and growing in, the 20% to 25% per year. And so, we think that we will get our share of that growth. And then I think as we bring out even our next large panel, we think that that will be a product that will make a significant impact in the market. So it's hard to say percentage wise, but I will tell you, we're starting from a low base, especially compared to our competitors. We look at Foundation, you look at Tempest, you look at [TREX]. I mean, these are companies that are probably doing high, high double-digits of their business in NGS and solid, we just haven't been. So, we think there continues to be a lot of runway there.
Tejas Savant: Got it. And a quick follow up on informatics, actually. Chris or Melody, perhaps, I'm just curious as to your updated thoughts there on better monetizing your informatics offering. And on a somewhat related note, you've talked in the past of, your product sort of moving towards more data intensive formats, whole genome sequencing, whole exome, et cetera. As you trend in that direction, do you envision an additional level of investment that's needed to build the infrastructure to support those backend analytics and so forth for those kinds of tests?
Chris Smith: Yes, I'm going to let Melody kind of get into the detail with you. But now, remember, she's only had it officially, I think, for like two weeks. But look, I think high level, we believe that there's opportunities, especially in these markets that are growing double-digits, we need to invest in them. I think, our view is, is that we think that the business in entirety, we talk about it being portfolio has the ability to grow, double-digits. And so, I think informatics is no different than our other businesses, where we think if we invest the right amount, we can we can drive growth. But some of that has to do with product and strategy. And that on that, let me kind of throw it to Melody to give you kind of some more color on that.
Melody Harris: Yes, so two weeks, I've been here to us on this project. So just looking at it and learning, but I but I do feel we have quite a bit of opportunity. We are only now with our limb system really transforming the underlying system such that we have the data structure for the backend analytics that you mentioned. And as we get into new product offerings with whole genome sequencing. With liquid biopsy, a lot of the magic of those products is in the backend pipeline. And so, we're already building that infrastructure for that, which then also lays the foundation for us, for purposes of monetizing that in a meaningful way. And so, if you think about data being the new oil, this means that we're going to have more oil production, coming from whole genome sequencing and liquid biopsy. So the team is very excited about those new product offerings, and what then that means for their product down the road from that.
Jeff Sherman: And I think from an investment perspective, we are continuing to capture gross margin savings and efficiencies throughout the company, and have several different work streams going towards that. So part of those savings, we can reinvest into things like informatics and R&D as well. So, there'll be profit growth from that, but there'll also be some reinvestment from some of those operational efficiencies that, we garner over the next couple of quarters and years.
Chris Smith: Yes. And speaking of the limbs, obviously that's going to be a big cost savings to move multiple systems onto one platform. And we've talked a lot about the limbs, but that really is the turbocharger for informatics growth. It's been very hard for us from an informatics perspective on multiple limb systems, to aggregate all that data and be able to have data scientists, create the things that we needed. So the limbs project, think about it almost as an R&D campaign for informatics. It's going to create that.
Tejas Savant: Got it. Appreciate the color guys. Thank you.
Chris Smith: Thanks.
Operator: Your next question is from Mike Matson (NYSE:MATX) with Needham and Company.
Chris Smith: Hi, Mike.
Mike Matson: Hi, guys. Just one on the patent litigation. So with this hearing on March 29, I guess, what is the next step? And is it just a decision on your appeal? And what's the expected timing of that decision?
Chris Smith: Yes, I'll let Ali take that.
Ali Olivo: Sure. So yes, what was appealed was the preliminary injunction. And typically, divisions take one to four months, depending on various factors, including if there's a dissenting opinion, sort of who the judges are, whether it's precedential in nature. And so, we're about one month out. And so, we don't really have greater visibility into the timing other than generally one to four months, with the four months being if it's precedential, or has a dissent.
Mike Matson: Okay. Thanks. And then with the new liquid biopsy test that you mentioned, I mean, how does that fit with the prior RaDaR? Is this RaDaR kind of 2.0? Is this something that – would you sell both versions of the test, assuming you get the preliminary injunction and return?
Warren Stone: So the liquid that we're looking to launch in the latter part of this year doesn't relate to MRD. It's really - it's a liquid test. It's a CGP pan-cancer liquid test that we're launching so that we're able to offer sort of concurrent testing opportunities with solid tumor and liquid biopsy.
Mike Matson: Got it. Okay. Thank you.
Chris Smith: Thanks.
Operator: Your next question is from Michael Ryskin with Bank of America.
John Kim: Hi, good morning.
Chris Smith: Good morning.
John Kim: This is John Kim on for Mike. You mentioned that you'd actually be looking at the higher end of the adjusted EBITDA guidance. So I wanted to ask on the price and the mix. I think you've previously talked about the NGS contributing more than 60% of the increase in AUP last quarter. I'm wondering what that was this quarter. And looking at the 2024 guide and looking at that adjusted EBITDA, if you had any change in your AUP expectations? Yes, and I guess related to that note, and how much improvement you're seeing in the revenue cycle. And I know you talked about that it's a multi-year opportunity, but what sort of upside is left this year?
Jeff Sherman: Yes, and so in terms of the pricing question, NGS continues to drive over 60% plus of the AUP increase. And so that trend has continued. In terms of revenue cycle, I mean, we have kind of a lot of initiatives under that umbrella. We have what you would consider your historical kind of billing and collections, denials, management piece. We're having success there. There is kind of conversion of tests from single panel to larger panel tests. That kind of falls under, what we would consider revenue cycle initiatives as well. And then, we have payer policy movements as well. So as state biomarker legislation continues to get passed, that's long-term favorable for us. That's going to take time to kind of matriculate through our performance, and getting payers to pay. So and then finally, there's the rate aspect where we're seeing rate increases. And so, I would say we continue to have success across all of those. They don't really start, or end in any one particular quarter. So I continue to see kind of a multi-year opportunity of seeing improvements there. And that's really where the focus is on getting paid for the work that we're doing, making sure we're getting. We're capturing the value of the service we're delivering to our clients and their patients. And I think that the progress has been good, and we still see a lot of opportunity to improve more going forward.
John Kim: Understood. And sort of related to it, you've doubled the sales force. And now as that team transitions to the under warrant, you talked about expanding it further. How should we think about this additional investment in the commercial team? Is that going to be - what sort of impact is that going to have on the financial statement?
Chris Smith: Yes, I would say, look, all of our strategies are kind of built into our guide. So anything that we would do investing this year, are already built into the guide.
John Kim: Noted. Thank you.
Chris Smith: Thanks.
Operator: Your next question for today is from Mason Carrico with Stephens.
Chris Smith: Hi, Mason.
Mason Carrico: Hi, guys. You gave some color on this in a previous question, but to ask it more directly, for the ADx business overall, is this still a business that you believe can consistently grow double-digits? And if so, what needs to happen to get there? And how do you think about the timeline to return to that level of growth?
Chris Smith: Yes, look, a couple of things on that. I mean, I think we do believe that business can grow double-digits. But that being said, I think we've got to make sure from a commercial optimization perspective that we have the right strategies in place. And I think also, some of the newer tests that we're bringing to market, I think, are going to help us significantly. So why, Neo Comprehensive 1.0 is a broad panel. I think getting our next gen big panel out there that's going to be one of the largest, if not the largest on the market, is going to have a big impact as well as liquid biopsy. So, I think one of the things with the pharma, is taking these new products and presenting them as new products. And then I think the other piece is, when we came in and we talked a lot about the clinical business bringing in Warren, we talked about salesforce optimization. And when you look at the clinical group, we were below best-in-class optimized sales force or effective sales force, is probably scoring about, what 60 on the Gardner scale. And we were well below 20. And I would say we've got a lot of things to lift that on the clinical side. You've seen those financial results. I would say - we did not go through that process on the pharma side, and we're just beginning that now. So, I think kind of the same thing with allowing Warren to get his arms around this business and understand it. But the market's there. So the question is not whether the market's there. The question is for us to put in the right strategies, and execute to do it. But to be fair, it's going to take quarters to get it going. I think we did make some good strategy moves on looking at optimizing the financials around that. Especially around the gross margin, and closing some of those out of the country, or global sites, and cutting loose some underperforming profitable customers. But now it's about the growth and getting it back to that growth mode.
Jeff Sherman: I think the other point is we have a relatively new sales force that has come on over the last couple of quarters. And so, I think there's also the component of this, of just the natural ramp there. And I think we have built a comprehensive sales structure, support structure under Warren on the clinical side that, will now be really available for the pharma side as well.
Mason Carrico: Got it. I'll keep it to one. Thanks, guys.
Chris Smith: Thanks.
Operator: Your next question for today is from Matt Sykes with Goldman Sachs.
Prashant Kota: Hi guys.
Chris Smith: Hi, Matt.
Prashant Kota: Thanks for taking the questions. This is Prashant on for Matt. Lots been covered already, but despite the increase sequentially in clinical revenues for this quarter, how much erosion of clinical testing volumes could have been attributed to winter seasonality? And then, how are you thinking about investments into digital pathology, across your business?
Chris Smith: So it's two questions. So you want to talk a little bit about that? And then I'll give Melody the second.
Ali Olivo: Yes. I think as Jeff mentioned in his commentary, we didn't actually see a meaningful change in our demand patterns in quarter one. And actually, just from a weather perspective, maybe there was marginally more weather phenomenon in this year versus last year. But it wasn't materially different. And as a result, we didn't actually see as large a dip as what we have seasonally seen in quarter one. So we saw what I would define as fairly robust volume demand, across all of our modalities in the first quarter.
Chris Smith: You're going to take it.
Melody Harris: Yes. On digital pathology, we do have a couple of internal initiatives. We do, to some extent, employ a level of digital H&E and other circling methodologies today. But to really do it at our full production scale, we're not seeing digital path AI vendors in the marketplace that have the breadth of our menu. So, we're trying to figure out ways that we would piece that together in a full scale production method. So today, we've done it opportunistically in taking some of the higher pain points and digitize that. But as far as across the board digital pathology solutions, we don't see that they're quite out there yet today.
Prashant Kota: Thank you.
Chris Smith: Thanks.
Operator: Your next question is from Andrew Cooper with Raymond James.
Chris Smith: Hi Andrew.
Andrew Cooper: Hi, everybody. Good morning. Thanks for the questions here. Lots already been asked, but maybe one more on MRD, and the mention of sort of the various different pathways you could go down. Just would love kind of the high level thoughts of how you think about the value of time from that perspective, and with the trial potentially starting in 2025 with the IPRs underway, the timeline of seeing those through to the end, versus potentially going another route where you could do something faster, even if it maybe costs a little bit more. Just help us think about how you balance those things as you think about what the next step should be to add MRD to the portfolio, from a commercial perspective?
Chris Smith: I think it's a good question. Look, we do have a lot of confidence in the legal strategy, because I think especially these IPRs, and I think that's gone kind of under the RaDaR through all of this, because we're going through the natural steps, but those are now final. And to see if we can get those patents overturned. And so, look, I think from a RaDaR perspective, we like that technology a lot. And the team had already started working on the next gen RaDaR product. So, I think we're not abandoning that path, but I think that being said, look, we're a company that sells over 600 cancer tests, and we know that MRD will be a product that needs to be there. But our ability, we have multiple NGS tests, so I think our ability to evaluate other options. I think, is just prudent on our part. It's one of the big projects that Ali and her team are looking at. There's a lot of interesting, innovative, early-stage companies out there from a technology perspective. So look, I think we would do that. As far as timing, look, I think at the end of the day, you've got to remember a lot of that product is still not getting reimbursed. I think they're, I think Natera has done a good job with multi-axing and getting coverage. But if you still look at the whole industry, it's pretty deep in colorectal, but not a lot of other cases. And there are some very good companies that are bringing those products to market in the next year or two, which we think will only grow the market at a faster rate and help adoption, especially from a payer perspective. But this is still so, it's such early days from MRD. I think it's almost like if you would go back with NGS 10 years ago, and today NGS is only, what, 30%, 35% penetrated. So, we think that this is going to be a long game with MRD, and we believe that with being the leading cancer company, it's going to be important to us, but it's also about being prudent, and making sure that we have multiple opportunities.
Andrew Cooper: Awesome. That's super helpful. Maybe just one more in terms of some of the sales force commentary. Can you just remind us from a numbers perspective, sort of where you sit in that precision oncology versus the traditional sort of call points? And then as well in ADx, and maybe versus those numbers where you'd like to be end of year, or long-term to the degree there's material change there?
Warren Stone: Yes. So, as Chris said earlier, we've sort of doubled our sales force in the last 18 months, which ultimately means we now have an organization that's north of 100 on the clinical side. And if you think of allocation of time, et cetera, that we apply, roughly 40% of the sales force time is now focused on the community oncology setting, with the remaining roughly 60% focused on our traditional call point with the pathology in the hospital. So, that's really the breakdown with regards to the clinical side of things. On the farmer side of things, just getting my arms around it, today we have less than 10 people within our commercial organization targeting our farmer customers, and I think there is a real opportunity for us to make investments here, but not necessarily what I'm going to call traditional investments. I think there is opportunities to drive a much more sophisticated sales, commercial strategy and sales deployment to support that. So, I wouldn't just think about this as scaling the number of BDs. I would think about this in a much more transformational manner and different solutions that will drive better efficiency and reduce cost to serve. So, I think investment's there, but two weeks out of the [bell], probably a little early for me to comment.
Andrew Cooper: Great. I'll leave it there. Thank you so much.
Chris Smith: Thanks, Andy.
Operator: We have reached the end of the question-and-answer session. And I will now turn the call over to management for closing remarks.
Chris Smith: Okay. Thanks so much, Holly, and everybody, thanks for taking the time to catch up with us today. As we talked about, it was a strong quarter, and we're pleased with the progress that we continue to make, and we'll look forward to catching up with you next quarter. Thanks and take care.
Operator: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
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