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. 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 Katherine Stueland, President and Chief Executive Officer; and Kevin Feeley, Chief Financial Officer. Earlier today, GeneDx released financial results for the third quarter ended September 30, 2024. Before we begin, please take note of our cautionary statement. 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 29, 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.genedx.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 GeneDx. We delivered over $76 million in revenue, expanded gross margin to 64%, and achieved our tenth 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 of 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 U.S. exome market share. Historically, our dominance is anchored in volumes from expert genetics providers. But beginning in 2023, we shifted our commercial focus to pediatric neurologists who represent 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 multiyear growth opportunity ahead as we remain approximately 12% penetrated amongst these specialists. As we look at the top 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 improvement and a partnership with Epic Aura. Recent product releases are already providing an uplift in this segment. 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 GeneDx to exome and genome testing into the workflows at many of the largest health systems across the country. We expect to begin receiving orders through our partnership 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 genome can be sequenced, 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 protocol tests 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 a condition with an FDA-approved therapy. We are approaching the genomic newborn screening opportunity with never before seen scale. In the short time-frame 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 absence of proactive genomic screening for these conditions, we're subjecting families to a multiyear diagnostic odyssey and settling 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 the 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 the long-term expected pediatrician call point to open up. Eventually, exome and genome will become standard first-line diagnostics for nearly all heritable disorders, including adult disorders. On average reimbursement rate, all uplifts have come from our efforts to reduce denials. In Q3 2024, the average reimbursement rate for exome and genome after all denials 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 that commercial payers is paying off. Additionally, Medicaid denials are decreasing as individual state policies evolve to cover exome and genome testing more broadly. That surround sound of clinical and health economic data, patient advocacy, and biomarker bills are having a positive impact on policy and reimbursement decisions at the state level. This quarter, Connecticut, Sparta, 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 historic guidance 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 entitled every Medicaid enrolled child to services that meet their unique medical needs, including diagnostic tools like exome and genome sequences. On COGS, our team has optimized the wet lab, and we see further opportunities in the next several quarters to enhance efficiency throughout what today is fairly manual drive-site profits. Turning to operating expense. Total adjusted 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 tenth consecutive quarter of cash flow improvement. On the balance sheet, our cash, cash equivalents, marketable securities and restricted cash totaled $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 million 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 million to $65 million of net cash for the full year of 2024, excluding the financing cost. And with that, I'll turn you back to Katherine.

Thank you, Kevin. As we exit the third quarter as a 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 a privileged position where what's best for patients is also 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, preventing disease progression and ensuring 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.

And our first question for today will be coming from Dan Brennan of TD Cowen. 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 you'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 your fourth quarter guide now compared to kind of normal seasonality?

Yes. Look, we're really pleased with the progress of the business and continued momentum heading into the fourth quarter. We previously talked that Q4 is typically seasonally strongest. That said, the early part of the fourth quarter here was impacted somewhat by the weather down in the Southeast, the hurricanes and tornadoes. So, I wanted to leave some room to see how long it takes until we see a snap back there while at the same time we've talked throughout the year about 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 for some of those toggles.

Could you provide some insights on your current position despite the strong growth? You've mentioned significant potential across various areas, and the volume growth in Europe has been impressive this quarter, especially considering the tough comparison, which will only get more challenging in the fourth quarter. Can you share more details about the differences between outpatient and inpatient, as well as new versus existing accounts? What factors are contributing to the robust volume growth in exome and genome?

Yes. 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 exome business. But I would say we did start to see, because of some product improvement last quarter, some nice growth on the NICU side. We have 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 the buccal swab for that NICU setting, which will have faster turnaround times. We will have repeat expansions, all of which will help continue to support our growth in that NICU setting as we head into 2025. So, I think we're really pleased to see it's kind of a diversification beyond the outpatient exome setting and starting to see some movement in that NICU setting, which just sets us up for a really strong outlook on 2025 growth in both settings.

And if I could sneak one last one in the CMS program you talked about in the prepared remarks, historic guidance, as you called it, unstated Medicaid plans. Can you just elaborate a bit? Does this essentially force Medicaid plans to adopt testing? Kind of when can you start accruing more broadly across those states that aren't covering it today? So, just give us a sense of that program and its potential impact?

Yes. I wouldn't go that far, Dan, with it. There's no real force 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 are unique and special needs, and we think much of our testing fits into that mold. But I wouldn't overstate to say that there's an enforcement regimen in place there.

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

Hey, good morning, guys. Thanks for taking the question. Just a couple of 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? 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 one follow-up.

Perfect. I think there's a number of things that are impacting utilization in the pediatric neurology setting. 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 with a seizure. This is 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 to really fuel their clinical trials and their pipeline for FDA-approved therapy. So, there's this incredible ecosystem play happening in order to benefit these children. It's not only about a diagnosis but there is something 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 ensures they understand the importance of getting a precise genetic diagnosis, so 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 therapies. It's very similar to the phenomenon that you see in cancer that you have seen on the cancer side of things for many years. We have a lot of education still to do about how much more within reach our testing is. Historically, it took a long time, it was expensive, and it was confusing when 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 3-week range versus even a 4-week range. Reimbursement is really strong in that setting, so it takes price off the table for most of these patients, 4 out of 5 have no out-of-pocket costs. Because we're continuing to resolve variants of unknown significance by upgrading and downgrading them, these results are actually more conclusive and less confusing. There are a number of things that we're doing to 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. On that note, where do you think penetration could potentially 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. As we've talked about the total addressable market in the outpatient, we see it being about $2 billion, which doesn't consider the expansion of testing beyond ICD-10 codes, which we are really driving towards. We want to make sure that any trial who has several of these symptoms—whether persistent seizures, it is milestones. It's usually a combination of multiple different types of symptoms that are showing up. That genetic testing should be used as early as possible to prevent progression of disease. So, we think that every pediatric neurologist should be utilizing the testing for these children who are presenting as a first line of treatment. And again, AES guidelines support that. We'll continue to work alongside AES, patient advocacy groups, which are wonderful partners in terms of educating providers to ensure that everyone has access to this testing.

Okay. That's great. And then 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 preparing to turn on rapid whole genome testing once you are live and launched with Epic? Or do we think of that as more the starting date and then there's a bit of a delay as accounts prepare to launch?

It's both. We are currently selling and actively driving volumes and institutional pay today. We are starting to bring on business and realizing the benefit for their patients today and for our business today. This is happening. Again, just as a reminder for everyone, this is an enterprise sales approach. We believe that Epic Aura will be an important catalyst next year. We'll begin accepting orders through that in the first half of the year, and we expect to see the impact in the second half of the year. We are continuing to do what I would call blocking and tackling in some of these health systems with the improvements we have. Several of these health systems are partnering with us in the outpatient setting, making it a natural extension into that NICU setting. We think that the Epic partnership is going to be an important catalyst for us.

And our next question will be coming from Mark Massaro 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 a multipart 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 and how it relates to cash burn? And then secondly, when do you expect to commercially launch your exome product and newborn? And the third one is more on the medical affairs or payer strategy side. How are you thinking about starting to 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 micro-deletion 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.

Yes. Maybe, Mark, I'll start with that first one. So, it's effectively in-kind consideration by each partner in the Guardian study—this includes GeneDx, Illumina, New York State, and New York Presbyterian. The lead PI is Wendy Cheung. 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, GeneDx providing the actual sequencing and interpretation, along with our labor and know-how effort there, each contributing what we do best at, frankly, with no cost to the families involved in this.

In terms of timing and payer strategy, I want to reemphasize some comments that we made that the absence of this testing is indeed bundling children through this multiyear 6- to 8-year diagnostic odyssey. That's a big problem we have to continue to solve today. But I think with that as a backdrop, it really 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 generating attention and interest in prospective parents. More than 70% of parents enroll in the study. The key question, of course, is who's going to pay for it. We think that it's going to take several years to ensure that policymakers appreciate it and we can determine exactly what that pull-through strategy will be. I'll remain optimistic about our ability to solve the business problems of it. There was an international conference on newborn screening here in New York a couple of weeks ago, and all the researchers coalesced around the fact that there's great evidence for clinical actionability, 4% is what we're seeing. The business problems we have to solve—that's what we're really good at at GeneDx. We're going to take our commercial team and our medical affairs team and continue to define the health economic argument that goes beyond the clinical utility we're seeing in the Guardian study. It will take at least 5-plus years before it really starts to take off in a meaningful way. We are spending time now to ensure we can be the ones to work with the entire ecosystem, including biopharma companies who have a really important interest. Several biopharma companies and patient advocates are the reason we expanded from screening for 200 conditions to 450.

Okay. That is really helpful. And then one for you, Kevin. I know you talked about your ASPs on exome and genome hitting $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 as we tweak our models for 2025 and perhaps beyond, how should we think about the upper limit of realizing ASPs on exome and genome?

Yes. One way I contextualize, Mark, is we're still at a point where our payment rate is in the mid-50s, and we certainly believe that a mature product in our space over time, one that fills a large unmet medical need and makes an impact on care ought to have a much higher payment rate than that, at least 70% to 80%. There is 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 form, which we will challenge ourselves to continue to reduce denials. 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 people and technology, and it's paying off. So, certainly optimistic that we can continue improvements.

Awesome. And then last one for me. It's for you, Katherine. You talk about longer-term wanting 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. We will continue to drive a business where there is line of sight between volume and getting paid for it. In the exome setting, there are a few areas that come to mind for us. One is adult neurodegenerative conditions like Parkinson's and Alzheimer's disease, among others, really thinking about drug development in those areas and others on the cardiovascular side. We will work deliberately to ensure that as we think about an adult opportunity in the future, it is again an ecosystem play, ensuring we generate data to get in front of payers, ensuring that payers are going to pay for it. When there are gene therapies, you need a genetic diagnosis. It remains an exome and genome test versus a screen. In the future, when we get to a place of doing newborn screening at birth for all babies, I could see us performing sequence testing on adults as well. We haven't begun scoping out what that could look like beyond that being an important vision and North Star for us. I would view the adult market as an extension of the test-by-test symptomatic market versus screening.

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 $7 million last quarter. But just given the profile of that revenue, I assume it had an outsized impact on profitability. From a modeling perspective, Kevin, how should we think about moving forward the prior period collections? Any kind of trends that you could help us with? What was the impact on profitability from that revenue coming in year-to-date?

Yes, as you pointed out, there are about $6 million of estimated true-ups. I would put that in the context of true-ups spanning a number of months or actually quarters. The GAAP calculations themselves tend to look at a historic lookback period to estimate collection rates by payer. 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 cycle where there are a number of quarters to come where we'll be on that side of the ledger. You should view the revenue recognition rate of $3,100 that you derive from our table in the back of the release as a new floor in which we'll build for GAAP revenue purposes moving forward.

Okay. And then one for probably both Katherine and Kevin. Just given the increase you've seen in all exome and genome revenues, would you consider being more aggressive about either winding down or disposing of some of your non-genome, non-exome testing? I think Kevin, you mentioned in response to the first question just about hereditary cancer. How do you consider the revenue versus margin implications? Because they're pretty significant for our modeling and just for the overall company. 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. As we look back from a year ago, we've now retired 70% of our test menu. We've made really meaningful progress in setting aside lower negative gross margin tests and ensuring that there is a healthy gross margin. We'll continue to wind down tests. Kevin mentioned in the fourth quarter, continuing to keep an eye on winding down additional tests from that menu. I'm pleased we've been able to make so much progress, and we do want to get to a place where we have a 2-test menu in exome and genome, ultimately running everything as genome for all. We want to reach that place over time, but again, ensuring that there's a clear reimbursement pathway.

The only thing I'd add to that, Matt, is that as Katherine said, we have retired 70% of the test menu in the past year. What remains, putting hereditary cancer aside for a moment, are all tests that we believe are long-term strategically important, as they would expect to convert to exome and genome once additional guidelines are put out. The largest portion of that volume line is chromosomal micro-array, which represents about 20% of all volume. We do think that long term, it's an excellent candidate to convert to exome and genome and is strategically important. Over the last year, we've made strides to improve the COGS profile of the remaining portfolio. CMA is one example where a year ago it was about a 30% negative gross margin. We've gotten that to about breakeven, with a path to further improvement.

And our next question will be coming from Brandon Couillard of Wells Fargo. Your line is open.

Hey, thanks. Good morning, Kathy, congratulations. Katherine, in relation to profitability, 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 priority to tap that list? And Kevin, how should we think about OpEx spend moving into '25 in that context?

Awesome. Thanks, Brandon. I think you're absolutely right about the way that we're thinking about investments. We're going to make, I would say, discrete meaningful investments that ensure we're balancing continued profitable growth while ensuring we can innovate to continue to lead the way, not just in exome but in genome. We've seen this year already our ability to invest in some of those disparate initiatives, whether it's Epic Aura or putting capital behind improving our genome product. We already released our buccal swab, which will have a 5-day turnaround time, and we will have repeat expansions. We will continue to make investments like that, and will track the ROI of each one to ensure they pay off. We'll do it in a 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. Again, that's institutional pay, so it's a healthy business. We're going to continue to strike a healthy balance in making product improvements, customer experience, and overall commercial growth investments in a deliberate and methodical way moving forward.

Maybe just to layer on that, the broader team functional teams have really built the muscle memory to look at ROI analysis, cost-benefit analysis, and we still expect payback in something like one to three years rather than three to five or beyond. All investments will be measured with respect to where we see near-term accelerators in terms of revenue growth or gross profit expansion. We see a number of things we can do to further accelerate the business. We're excited to analyze those. However, you should expect that we're taking the same level of rigor that got us to this point of bringing profitability moving forward. From an OpEx standpoint, we expect some incremental aggregate dollars, but still expect a period over the next year where OpEx as a percent of revenue could slightly decline as revenue and gross 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? Is there some mix impact embedded in there? It would 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?

Yes. The at least 62% implies two components—one, it's at least 62%, so 62% or higher. And again, that's for the full year. There's some weighted math going on, and we 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.

Hey, thanks. Maybe sticking with gross margins, Kevin. Q3 saw a more meaningful step-up than we saw in the first half from low 60s moving towards mid-60s—about 300 basis points. I think you called out kind of mix reimbursement, better cost, and a 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?

Yes, I'd probably weight them with average reimbursement rate first, then cost per test, and then mix. Where we continue to see opportunity moving forward is if you look at our COGS stack, about a third of it resides in what I'll call the dry side processes. After the sequencing book and before report writing, 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 would expect that component to provide bigger proportionate share of expansion gains as we head into '25 and beyond. Yes. A typical lag of one to two quarters is not unreasonable. I would really expect more of a 2025 impact for those states that we announced to enhance or put in policy this year.

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 Katherine 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 today's conference call. You may all disconnect.