GeneDx Holdings Corp.

Thank you for standing by, and welcome to the GeneDx Third Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. And after the speaker's presentation, we will have a question-and-answer session. Keep in mind that this call is being recorded. If you would like to ask a question, please press star-one-one on your telephone, and you will hear an automated message advising your hand is raised. I would now like to turn the call over to Sabrina Dunbar, Investor Relations. Please go ahead.

Thank you, Operator, and thank you to everyone for joining us today. On the call, we have Catherine Stuland, President and Chief Executive Officer, and Kevin Feeley, Chief Financial Officer. Earlier today, GDX released financial results for the third quarter ended September 30, 2024. Before we begin, please take note of our cautionary statements. we may make forward-looking statements on today's call, including about our business plans, guidance, and outlook. Forward-looking statements inherently involve risks and uncertainties and only reflect our view as of today, October 29th, and we are under no obligation to update. When discussing our results, we refer to non-GAAP measures, which exclude certain items from reported results. Please refer to our third quarter 2024 earnings release and slides available at ir.gndx.com for definitions and reconciliations of non-GAAP measures and additional information regarding our results, including a discussion of factors that could cause actual results to materially differ from forward-looking statements. And with that, I'll turn the call over to Katherine.

Thanks, Sabrina, and thank you all for joining us. The third quarter was an exceptionally strong quarter for GDX. We delivered over $76 million in revenues, expanded gross margins to 64%, and achieved our 10th consecutive quarter of cash burn reduction. Our organizational focus and discipline continued to fuel our growth, and we achieved profitability in the third quarter. This milestone is an important one in the industry. We've demonstrated that you can prioritize patient care and do it while running a successful business. And as we walk through the door of profitability, we're entering a new phase of growth for GeneDx. one in which we hold a sustainable and durable market leading position in exome and genome testing and translate our leadership to serve all patients who can benefit from genomic insights. On the back of a strong Q3, we're raising our revenue guidance for the full year 2024 to between $284 million to $290 million. We're bullish on our ability to keep expanding our footprint to the pediatric outpatient setting and begin extending our reach into new clinical settings in the years to come. Our work is just getting started. Today, we enjoy 80% of the US exome market share. Historically, our dominance was anchored in volumes from expert genetics providers, but beginning in 2023, we shifted our commercial focus to pediatric neurologists who represented the next rung of clinicians primed for a more comprehensive approach to genetic testing. While these pediatric neurologists have significantly expanded adoption and fueled growth over the last 12 months, there remains an ample multi-year growth opportunity ahead as we remain approximately 12% penetrated amongst these specialists. As we look at the path in front of us, there are many untapped growth catalysts yet to be unlocked. We see expanded clinical indications for exome and genome, entry into the general pediatrician market, and the development of additional patient access channels as opportunities to cultivate new arenas for our market leadership. We're proud to share that as of Q3, we've officially sequenced over 700,000 clinical exomes and genomes, completing over 100,000 of those sequences in the last six months alone. This acceleration is a testament to growing utilization of our exome and genome testing while creating a flywheel effect for our business. With every test we complete, we deepen our understanding of disease gene correlations to inform more definitive diagnoses for more patients. We unlock improved operational efficiency and lower costs, and we further differentiate our products from those of our competitors. This acceleration in volume also demonstrates our ability to scale our data engine and positions us to be a key strategic partner for biopharma. We're leveraging our growing data asset to deliver value to biopharma companies big and small while supporting our own commercial initiative, as evidenced by our Epilepsy Partnership Program, which improves access to testing for children with epilepsy while delivering valuable insights to biopharma looking to inform their drug development efforts with new targets and find patients to enroll in active clinical trials. In the NICU, we're seeing a steady increase in rapid whole genome volume quarter over quarter, as we set the stage for a broader push in 2025. We announced in Q2 that we've taken steps to solidify our position in this growing market with product improvements and a partnership with Epic Aura. Recent product releases are already providing an uplift in this segment, and we're proving that our product and technology approach is effective. Regarding Epic, we're well on our way to implementing our partnership, which will seamlessly integrate GDX exome and genome testing into the workflows at many of the largest health systems across the country. We expect to begin receiving orders through ORA in the first half of 2025, with revenue ramping in the second half of the year. Our experience in the NICU has demonstrated time and again the power of a genetic diagnosis to change the course of a baby's life. We also know there's an opportunity to intervene even earlier. We believe in a world where every newborn's genome can be sequenced at birth, And we're confident GeneDx will lead this opportunity to revolutionize the traditional approach to newborn screening by adding genomic sequencing. Today's traditional newborn screening protocols test for about 60 conditions. But with the addition of genomic sequencing, newborn screening can be enhanced to screen for more than 450 actionable conditions. For some of these families, actionability can be as simple as changing their baby's diet, And for others, it can mean enrolling in a clinical trial or treating the condition with an FDA-approved therapy. We are approaching the genomic newborn screening opportunity with never-before-seen scale. In the short timeframe we've invested in the space, we've sequenced more than 15,000 newborns, which is more than any other lab in the United States. We began work with the Guardian study merely two years ago, and the findings of that research were published last week in the Journal of the American Medical Association, a leading peer-reviewed publication. An analysis of Guardian participants found a nearly 4% positivity rate with genomic newborn screening. Dramatically, 92% of newborns with true positive results would have been assumed healthy and sent home using today's traditional newborn screening. In an absence of proactive genomic screening for these conditions, we're subjecting families to a multi-year diagnostic odyssey and funneling a pipeline of sick kids directly into our healthcare system. In the meantime, we have an incredible opportunity to serve an ever-growing number of patients and their families who are symptomatic today with our industry-leading exome and genome testing. Our focus and financial discipline, combined with the proven clinical utility of our testing, are setting us up for the next phase of sustainable growth, and we're excited by the opportunities ahead. And with that, I'll turn it over to Kevin.

Thanks, Katherine, and good morning, everyone. In the third quarter of 2024, our revenues from continuing operations reached $76.6 million. That's a 52% increase from Q3 2023 and 11% sequentially from the second quarter of 2024. Exome and genome revenues grew 77% year-over-year and 18% sequentially, contributing $60 million this quarter. The growth was driven by both volume and collection performance. Adjusted gross profit from continuing operations for Q3 2024 was $49.3 million, which is up 103% compared to the same quarter last year, and up 16% sequentially from the previous quarter. That translates to a gross margin of 64% up from 48% a year ago and 62% last quarter. Margin expansion benefited from all three of better average reimbursement rates, lower cost per test, and favorable mix shift. Regarding volume and mix, exome and genome tests accounted for 33% of all tests this quarter, up from 23% a year ago and 31% in the previous quarter. Our team delivered over 19,000 exome and genome tests this quarter. That's up 46% year-over-year and 7% sequentially. We continue to expect an inevitable long-term replacement cycle of the industry's gene tests and multi-gene panels into exome and whole genome. We're in the early innings of penetrating the outpatient specialist market and are poised to layer on the NICU service opportunity in the back half of 2025 and long-term expect the pediatrician call point to open up. Eventually, exome and genome will become standard first-line diagnostics for nearly all hereditable disorders, including adult disorders. On average reimbursement rates, all uplifts have come from our efforts to reduce denial. In Q3 2024, the average reimbursement rate for exome and genome after all denial was approximately $3,100, up from $2,800 last quarter, and up from approximately $2,600 in the same quarter of last year. Our work to refine insurance-specific workflows to minimize administrative and procedural denials at commercial payers is paying off. Additionally, Medicaid denials are decreasing as individual state policies evolve to cover exome and genome testing more broadly. That's a round sound of clinical and health economic data, patient advocacy, and biomarker bills for having a positive impact on policy and reimbursement decisions at the state level. This quarter, Connecticut, Florida, Indiana, and Texas all expanded or implemented enhanced policy. And while the state-by-state approach to expanding coverage is taking hold, we've also seen promising support at the federal level. Recently, CMS issued, quote, historic guidance, quote, to state Medicaid agencies underscoring their obligation to provide all medically necessary services under the Early and Periodic Screening, Diagnostic, and Treatment Program, or EPSDT, which entitles every Medicaid-enrolled child to services that meet their unique medical needs, including diagnostic tools like exome and genome sequencing. On COGS, our team has optimized the web lab and we see further opportunity in the next several quarters to enhance efficiency throughout what today is fairly manual drive-side process. Turning to operating expense, total adjusting operating expense for Q3 2024 were $46.6 million. This team has built the skill set of balancing innovation and growth with financial discipline and stewardship to all that we do to drive leverage. And on the bottom line, Total company adjusted net income for Q3 2024 was $1.2 million, marking the first positive quarter on that basis since inception. Our net cash burn for the third quarter was $5 million, an 88% improvement year-over-year and 17% improvement sequentially. This quarter marks our 10th consecutive quarter of cash flow improvement. On the balance sheet, our cash, cash equivalents, marketable securities, and restricted cash total $117.4 million as of September 30, 2024, inclusive of proceeds of $14.6 million net of fees for the issuance of 418,653 shares of common stock in connection with at-the-market sales during the third quarter of 2024. The outstanding share count as of September 30, 2024, stands at 27,433,803 Class A common shares. Now, looking ahead, we're again raising our revenue guidance for the full year of 2024 to between $284 and $290 million. We're also raising our adjusted gross margin guidance, expecting it to be 62% for the full year. Additionally, we're improving our net cash burn guidance, now anticipating using $60 to $65 million in net cash for the full year of 2024, excluding the financing process. And with that, I'll turn you back to Catherine.

Thank you, Kevin. As we exit the third quarter of profitable business, we're more confident than ever that we have a long runway of growth ahead of us. We've struck the balance between financial discipline and strategic investment, and we are in the privileged position that what's best for patients is also what's best for our business. While we continue to cement our leading position in the pediatric and rare disease market with substantial room to grow, we've turned our eyes towards the future, a future in which any genetic disorder is diagnosed quickly prevent disease progression and ensure long and healthy lives for all. Fueled by our dedication to a healthier tomorrow, we're committed to ending the diagnostic odyssey today. We're not just imagining a healthier future, we're building it one diagnosis at a time. And with that, we'll open it up to questions.

Thank you. As a reminder, if you would like to ask a question, please press star 11 on your telephone. If you would like to remove yourself from the queue, press star 11 again. We also ask that you please wait for your name and company to be announced before you proceed with your question. And our first question for the day will be coming from Dan Brennan of TD Cal when your line is open.

Great. Thanks for the question. Congrats on a strong quarter. Maybe the first one just on the guidance, pretty healthy raise. Can you just give us a sense on how we're thinking about the fourth quarter? Obviously, you're pointing to around $80 million, but when you think about the volume price for exomes and genomes, maybe can you just give us some flavor there? And how does, like, your fourth quarter guide now compare to kind of normal seasonality?

Yeah. Hi, Jay. Good morning. Look, we're really pleased with the progress of the business, continued momentum heading into fourth quarter. We previously talked that Q4 is typically seasonally strongest. That said, the early part of the fourth quarter here was impacted some by the weather down in the southeast, the hurricanes and tornadoes. So wanted to leave some room to see how long until we see a snapback there at the same time as we've talked throughout the year. wanting to leave some room in the guide if we were to make some unilateral decisions with respect to the non-exome and non-genome portion of the portfolio, namely hereditary cancer and some other non-exome tests. We expect that the fourth quarter will be seasonally stronger, but left some room in the guide there for some of those toggles.

And could you give us, I mean, obviously the prepared remarks spoke to, you know, the early nature of where you sit today, despite the really strong growth. You've got a lot of upside across a lot of different planes. You have a volume growth really good in the quarter in Europe against a tough comp, and the comp gets harder in the fourth quarter. So could you give us a little flavor of kind of, you know, maybe between outpatient and inpatient, maybe new accounts versus existing accounts, any color on kind of what's driving that really strong volume growth excellence in genomes?

Yeah, we're still seeing a tremendous amount of growth with new accounts and with same-store sales in that outpatient setting, which, again, is predominantly our ex-home business. But I would say we did start to see, because of some product improvements last quarter, we have seen some nice growth on the NICU side of things as well as we turn our sights towards really ensuring that we can translate that same leadership that we have in exome to genome in the NICU setting. So, you know, we've ramped up our commercial efforts there. We've talked about the future with Aura. We're continuing to improve beyond sample collection, so we released a cheap swab for that NICU setting. We'll have faster turnaround times. We will have repeat expansions, all of which will help really continue to support our growth in that NICU setting as we head into 2025. So I think we're really pleased to see kind of a diversification beyond the outpatient exome setting and starting to see some movement in that NICU setting, which I think just sets us up for a really strong outlook on 2025 growth in both settings.

If I could speak one last one. The CMS program you talked about in the prepared remarks, historic guidance, as you called it, on state Medicaid plans. Can you just elaborate a bit? Does this essentially force Medicaid plans to adopt testing? When can you start accruing more broadly across those states that aren't covering it today? Just give us a sense on that program and its potential impact.

Yeah, I wouldn't go that far, Dan, with it. There's no real forced mechanism there. It's more of a reinforcement of what is existing guidance by CMS to individual state programs for a unique program for early childhood diseases and disorders for states to cover where there's unique and special needs. And we think much of our testing fits into that mold of unique and special needs. But I wouldn't overstate to say that there's an enforcement regimen in place there.

Got it. Okay. I'll get back in the queue. Thank you.

Thank you.

One moment for the next question.

And our next question will be coming from William Bonello of Craig Hellam Capital Group. Your line is open.

Hey, good morning, guys. Thanks for taking the question. Just a couple quick things. Can you talk a little bit about some of the actual initiatives that you have in place to drive increased penetration with the pediatric neurologists? I mean, what do you do to get more of them using the testing? And where do you think penetration can go over time? And then I have, you know, one follow-up.

Perfect. You know, I think there's a number of things that are impacting utilization in the pediatric neurology setting. And I guess at a high level, there's our own efforts, but they are, I think, joined by guidelines from the American Epilepsy Society that really amplify the need for exome testing for any child who has a seizure. And then I think it's further amplified by continued reimbursement in that setting, not to mention the fact that there are many companies on the biopharma side of things who are all out there educating pediatric neurologists in order to really fuel their clinical trials and their pipeline for FDA approved therapies. So there's really this incredible ecosystem play that is happening in order to benefit these children. So there's not only a diagnosis, but there's something that is clinically actionable on the other side of that diagnosis by way of a study or an FDA approved therapy. The work that we're doing on the sales and medical affairs side of things is we're going in, we're showing them data that really ensures that they understand the importance of getting a precise genetic diagnosis and not just doing a brain scan, but really understanding if there is an underlying genetic cause for these seizures in particular. You need to know exactly what is happening from a genetic standpoint in order to be eligible for those clinical trials or FDA-approved therapies. And so it's very similar to the phenomenon that you see on the cancer side of things and that you have seen on the cancer side of things for many years. We have a lot of education still to do just about how much more within reach our testing is. Historically, it took a long time It was expensive and it was confusing once you got an answer. But thanks to the technology improvements and scale that we've been able to build into our business, our turnaround times are now in the three week range versus even a four week range. Reimbursement is really strong in that setting. So it takes price off the table for most of these patients. Four out of five have no out of pocket And then because we're continuing to resolve variants of unknown significance for upgrading and downgrading them, these results are actually more conclusive and less confusing. So there's a number of things that we're doing to really educate pediatric neurologists about why they should use genetic testing versus other modalities that are inconclusive and continue to drive costs in the healthcare system and why we are easier to work with.

That's really helpful. And just on that, where do you think penetration could maybe go?

So as we said earlier, we're at about 12%. We're aiming to make sure that every pediatric neurologist who has a child with a seizure is getting a genetic test. So as we've talked about the total addressable market in the outpatient setting being about $2 billion, that doesn't contemplate really an expansion of testing beyond ICD-10 codes, which is what we're really driving towards. We want to make sure that any child who has several of these symptoms, whether it is persistent seizures, if it's missed milestones, it's usually a combination of multiple different types of symptoms that are showing up, that genetic testing is being used as early as possible to prevent progression of disease. We think that every pediatric neurologist should be utilizing this testing for these children who are showing up as a first line of treatment. And again, AES guidelines support that. And so we'll continue to work alongside AES. Patient advocacy groups are wonderful partners in terms of educating providers as well to make sure that everyone has access to this testing.

Okay, that's great. And then just the second question I had was just on the NICU penetration and sort of how we think about the ramp there. Are there accounts that are essentially, you know, preparing to turn on, you know, rapid whole genome testing once you are live and launched with Epic, or do we think of that as more kind of the starting date and then there's a, you know, a bit of a delay accounts prepare to launch?

It's both. So we are currently selling and actively driving volumes and institutional pay today. So we are able to start bringing on business and realizing the benefits for their patients today and for our business today. So that is happening. Again, just as a reminder for everyone, this is an enterprise sales approach. So we're going in, our chief medical officer, our enterprise sales team will go in and sell a system-wide approach to embedding testing. Without a doubt, we believe that Epic Aura will be an important catalyst next year. We'll begin actually accepting orders through that in the first half of the year. And we expect that we'll start to see the impact of that in the second half of the year. We're continuing to do what I would call blocking and tackling in some of these health systems with the improvements that we've had. Several of these health systems, they're partnering with us in the outpatient setting, so it's a natural extension into that NICU setting. But next year, as we think about the potential to really drive more meaningful volumes and revenues, and importantly, more diagnoses faster for more of these families, We think that the EPIC partnership is going to be an important catalyst for us.

Okay. Thank you very much. Appreciate your taking all those questions.

Thanks, though.

Thank you. One moment for the next question, please.

And our next question will be coming from Mark Cesaro of BTIG. Your line is open.

Hey, guys. Thank you very much for the questions, and congrats on the quarter. I wanted to start on the JAMA study and the Guardian readout. Pretty impressive stuff. So I guess, multi-part question here. First, can you remind us who is paying for the study? I see it's a collaboration among academic institutions and Illumina is involved as well, but I just wanted to double check how much of this study you guys are paying for. how it relates to cash burn. And then secondly, when do you expect to commercially launch your exome product to newborns? And then the third one is more on the medical affairs or payer strategy side. How are you thinking about starting to potentially work with medical societies and getting payers to pay for newborn screening. I know a number of us are familiar with Natera's strategy in microdeletion screening, and it has taken them a little bit of time getting in front of ACOG. So maybe help us determine if ACOG is one of these groups, but give us a sense for timing, both on commercial launch and on guidelines.

Yeah, maybe, Mark, I'll start with that first one. So it's effectively in-kind consideration by each partner in the Guardian study. So that would include GDX, Illumina, New York State, and New York Presbyterian. The lead PI is Wendy Chung. She was formerly with Columbia. Now she's with Boston Children's Hospital with Wendy and her team. contributing principal investigation type of work, Illumina providing reagents, GDX providing the actual sequencing and interpretation. And so our labor and know-how effort there, each contributing what we do best at, frankly, with then no cost to the families involved in this.

In terms of timing and pair strategy. One, I want to reemphasize some of the comments that we made that the absence of this testing is indeed funneling children through this multi-year six to eight year diagnostic odyssey. And that's a big problem that we have to continue to solve today. But I think with that as a backdrop, I think it really further cements how important it is that we continue to accelerate the opportunity in the newborn screening setting. It's going to take a lot of work. We talk about the Guardian study as being proof of principle. Wendy has done a masterful job in showing that she can generate the attention and interest in prospective parents. So more than 70% of parents enroll in this study. But the key question, of course, is going to be who's going to pay for it. And we think that that's going to take us several years to really continue to make sure that policymakers appreciate it, that we can figure out exactly what that pull-through strategy is going to be. I tend to be optimistic about our ability to solve the business problems of it. I think if you There was just the International Conference on Newborn Screening here in New York a couple weeks ago. And all of the researchers, I think, are coalesced around there is great evidence, particularly given the fact that this is the largest study that's been done in the U.S. There's great evidence on clinical actionability. Four percent is what we're seeing. But the business problems that we have to solve, that's what we're really good at at GDX. And so... We're going to take our commercial team, our medical affairs team, we're going to continue to figure out the health economic argument that really goes beyond the clinical utility that we're seeing in the Guardian study. So, I think our view on it remains it will be in the five plus year timeframe before it really starts to take off in a meaningful way. But we are spending time on it today to make sure that we can be the ones who work with the entire ecosystem, including biopharma companies who have a really important interest. Several biopharma companies and patient advocates are the reasons that we have expanded from 200 conditions that we're screening for to 450. So we'll work in collaboration with all of them to figure out the commercial strategy and the payer strategy for that as well.

Okay, that is really helpful. And then One for you, Kevin. I know you talked about your ASPs on Exome and Genome hit $3,100 in the quarter. That's up $500 year over year. I don't think you have, but do you think you've hit a wall there, or at least have you reached a limit on the $3,100? Just give us a sense. I know that when you get paid in full, I think you're a little bit higher than that. So I'm just trying to get a sense as we are tweaking our models for 2025 and perhaps beyond, how should we think about the upper limit of realizing ASPs on exome genome?

Yeah, maybe one way I'd contextualize, Mark, is we're still at a point where our payment rate is in the mid-50s and certainly believe a mature product in our space over time, one that we believe is fills a large unmet medical need and really makes an impact on care, ought to have a much higher payment rate than that, at least 70% to 80%. So still a long way to go to ensure we're getting paid consistently at normalized rates there. So we consider the $3,100 here a new floor in which we'll challenge ourselves to continue to reduce denials. In large part, many of them still remain administrative and procedural. I'm really pleased with the progress the team has made. About a year ago, we invested a lot of resources in terms of people and technology, and it's paying off. So certainly optimistic that we can continue improvements there.

Awesome. And then last one for me. It's for you, Catherine. You know, you talk about longer term. You want to provide exome and genome tests to adults. Is there sort of a guardian study for adults in the works? Can you just give us a sense for what you're doing in terms of getting in front of collaborators to show the evidence of why this test would be helpful in adults?

Certainly. I think one of the key principles for us over the past several years that has differentiated us from labs of past is making sure we can get paid as often as possible for our testing. So we're going to continue to drive a business where there is line of sight between volume and getting paid for it. I think as we think about the adult setting, there's a few areas that come to mind for us One is, of course, adult neurodegenerative conditions like Parkinson's and Alzheimer's disease, amongst others, and really thinking about drug development in those areas. Another is on the cardiovascular side of things, and again, taking a look at where biopharma companies are investing their capital as well. So we're going to work... you know, in a really deliberate way to ensure that as we think about an adult opportunity in the future, it is, again, that total ecosystem play, ensuring we generate data to get in front of payers, ensuring that payers are going to pay for it, seeing what biopharma companies, what their needs are, because you can't treat it if you can't diagnose it. So where there are gene therapies, you need a genetic diagnosis. The way that I would say, though, Mark, I think it still remains like an exome genome test versus a screen. In the future, when we get to a place where we are doing newborn screening at birth for all babies, I could see us at that point in time. In the future, flip to being able to do a sequence and hold on adults as well. We haven't begun scoping out what that could look like, you know, beyond that being an important vision and North Star for us. But I would almost view the adult market as being an extension of the test-by-test symptomatic market versus screening market as we look to be able to continue to open up access to broader patient populations.

That's all very helpful. Thanks so much.

Thank you. One moment for the next question. And our next question will be coming from Matt Sykes of Goldman Sachs. Your line is open.

Hi, good morning. Thanks for taking my questions. Congrats on another good quarter. I guess I just wanted to, more of a modeling question, but maybe just talk a little bit about the impact of prior period collections. I think you did 6.3 million this quarter, down from seven last quarter, but Just given the profile of that revenue, I assume it had an outsized impact on profitability. And so just from a modeling perspective, Kevin, I guess, how should we think about moving forward, the prior period collections, any kind of trends that you could help us out with, and what was the impact of profitability from that revenue coming in year to date?

Yeah, as you pointed out, about $6 million of estimate true-ups, although I put that in the context of true-ups banding a number of months or actually quarters. And the way I would think about it is that the gap calculations themselves tend to look at a historic look-back period to estimate collection rates by payer. And frankly, we've been outperforming past estimates. That's where we want to be with respect to those true-ups and still think we're in a a cycle where there's a number of quarters to come where we'll be on that side of the ledger so do view sort of the rev rec rate of thirty one hundred dollars that that you can derive from our table uh in the back of the release as a new floor uh in which we'll build for for gap revenue purposes moving forward okay thank you and then one for probably both catherine and kevin just

Just given the increase you've seen in whole exome and genome revenues, would you consider being more aggressive about either winding down or disposing of some of your non-genome exome testing? I think, Kevin, you mentioned in response to the first question just about hereditary cancer, maybe something you called out. But would this be, you know, how do you consider sort of the revenue versus margin implications? Because they're pretty significant for our modeling and just for the overall company. And if you were to be more aggressive about winding that down, could you sell some of these types of tests like hereditary cancer, or would it just be sort of winding down that business as the exome genome grows?

Sure. I'll kick it off and then hand it over to Kevin. You know, I think as we look back from a year ago, we've now retired 70% of our test menu. And so we've made really meaningful progress in shedding the – low or negative gross margin tests, and really staying focused on tests that, one, provide the best patient care, two, ensure that there's healthy gross margin, and will continue to wind down tests. Kevin mentioned in the fourth quarter, you know, continuing to have an eye towards winding down additional tests from that menu. So, I'm pleased that we've been able to make so much progress, and we do want to get to a place where we have a two-test menu, an exome and a genome, ultimately running everything, staff genomes for all. So, we do want to get to that place over time, but again, making sure that there's a clear reimbursement pathway.

Yeah, the only thing I'd add to that, Matt, is, as Catherine said, retiring about 70% of the test menu in the past year. What remains maybe putting aside hereditary cancer for a moment. Outside of that line, what remains in the non-exome, non-genome test line are all tests that we believe are long-term strategically important in that they would expect to convert to exome and genome once additional guidelines are put out. The largest portion of that volume line is chromosomal microarray represents about 20% of all volume. That test we do think long term is absolutely a great candidate to convert to exome and genome. And so strategically important and at the same time over the last year we've made strides to improve the COGS profile of the remaining portfolio. CMA one example where it was about 30% negative gross margin a year ago, we've gotten that to about break even. with, we think, a path to further improve upon that. So, a lot of rigor going into what is the remaining test menu, as Catherine alluded to, with a filter to say is it margin, positive, and accretive, and or a good strategic fit to build the exome genome business over time.

Thanks. Very helpful.

Appreciate it.

Thank you. One moment for the next question. And our next question will be coming from Brandon Collier of Wells Fargo. Your line is open.

Hey, thanks. Good morning. Kevin, congratulations on crossing the profitability line. How should we think about incremental investments over the next six to 12 months now that you are profitable? Are there some projects that have maybe been on the shelf that will be priorities at the top of that list? And Kevin, how should we think about OpEx spend moving into 25 in that context?

Awesome. Thanks, Brandon. You know, I think you're absolutely right about the way that we're thinking about investments. We're going to make, you know, I would say discreet, meaningful investments that ensure that we're balancing continued profitable growth while ensuring that we can innovate to continue to lead the way, not just in exome but in genome. So, I think what we've seen this year already is our ability to place some of those disparate bets, whether it's Epic Aura, if it's putting capital behind improving our genome product, which we've discussed all in the works. We already released our buckle swab. We will have five-day turnaround time, and we will have repeat expansions. So it's continuing to make disparate investments like that. that will track the ROI of each one of those to make sure that they are paying off. We're going to make sure that we do it in a really methodical way. I'm happy to say that on the genome improvements, we started to see the results of that by way of volumes coming through. And again, that's institutional pay, so it's really healthy business. we're going to continue to strike a really healthy balance in terms of making the product improvement, the customer experience, and the overall commercial growth investment in a really deliberate and methodical way moving forward.

Yeah, maybe just to layer on, you know, the broader team, functional teams have really built the muscle memory to look at ROI analysis, cost benefit analysis, and we're still in a period where we expect payback in something like one to three years rather than three to five or beyond. So all investments will be measured with respect to where do we see near term accelerators in terms of revenue growth or gross profit expansion. we see a number of things that we believe we can do to further accelerate the business. So excited to analyze those, but certainly you should expect that we're taking the same level of rigor that got us to this point of brand and profitability moving forward. From an OPEX standpoint, maybe some incremental aggregate dollars, but still expect a period over the next year where that OPEX as a percent of revenue could slightly decline as revenue and growth profit outpace any incremental additions to OPEX.

Okay, that's helpful. And then, Kevin, I think the guide implies gross margins actually stepped down a little bit sequentially in the fourth quarter. Is that just conservatism, or is there some mixed impact embedded in there? And it'd be helpful if you could update us on Just the gross margin profile by test franchise and where you see the biggest opportunity for improvement. Thank you.

Yeah, so at least 62%, I'd say two components of that one, it's at least 62%, so 62% or higher. And again, that's for the full year. And so there's some weighted math going on. Effectively, expect margins to stay roughly flat with where they are in Q3 as we head into Q4. So, the guide implies roughly flat, and we'll try to beat that. Very good. Thanks.

Thank you. One moment for the next question.

And our next question will be coming from Matt Statton of Jefferies. Your line is open.

Hey, thanks. Maybe one sticking with gross margins, Kevin. 3Q saw a more meaningful step up than we saw in the first half from low 60s moving towards mid 60s or about 300 basis points. I think you called out kind of mixed reimbursement, better cost, number of drivers of that. Is there anything that was more meaningful than others or was it kind of equal weighted? And then as we start to think about 25, can you talk about some of the levers for ongoing improvement as we build off the updated 24 guide for the at least 62% on the gross margin side?

Yeah, I'd probably weight them with average reimbursement rate and then cost per test and then mix. But where we continue to see opportunity moving forward is if you look at our COG stack, about a third of it resides in what I'll call the dry side processes. So after the sequencer, but before report writing or including report writing, still fairly manual steps today. with a lot of effort and resources going in manually, we think those processes are good candidates for further automation. And so we're investigating any tools that might help us unlock further cost-per-test savings and would expect that component to have the bigger proportionate share of expansion gains as we head into 2025 and beyond.

Okay, that's really helpful. And then, nice to see the continued whole exome genome sequencing coverage by the states. In terms of some of the more recent wins, how do we think about the larger states like Texas in September, Florida here in October on the whole genome side? Can you just remind us on how quickly those coverage decisions can and will impact your business? Thanks.

Yeah, a typical lag of one to two quarters is not unreasonable. And so would really expect more of a 25 impact for those states that we announced enhanced or put in policy this year.

Thank you. Thank you. And that does conclude the Q&A session for today. And I would like to go ahead and turn the call over to Catherine for closing remarks. Please go ahead.

Great. Well, thank you all for joining us. We look forward to seeing you at upcoming conferences. Thanks so much. Have a good day.

This concludes this conference call. You may all disconnect.