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. [Operator Instructions]. 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 represented the next rung of clinicians primed for a more comprehensive approach to genetic testing. While these pediatric neurologists have significantly expanded adoption and fuel 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…

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 Test 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 inevitable long-term replacement cycle of the industry's gene test 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 expected pediatrician call point to open up. Eventually, exome and genome will become standard first-line diagnostics for nearly all or edible disorders, including adult disorder. On average reimbursement rate, all uplift have come from our efforts to reduce denials. 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…

Thank you, Kevin. As we exit the third quarter 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 that what's best for patients is also access 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 obvious today. We're not just imagining a healthier future. We're building it on diagnosis at a time. And with that, we'll open it up to questions.

[Operator Instructions] 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 like your fourth quarter guide now compared to kind of normal seasonality?

Yes. 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, I wanted to leave some room to see how long until we see a snap back 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-exon 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 the early nature of where you sit today despite the really strong growth, you've got a lot of upsides across a lot of different planes. The volume growth really good in the quarter in Europe in a tough comp and the comp gets harder in the fourth quarter. So, can you give us a little flavor of kind of maybe between outpatient and inpatient maybe new accounts versus existing accounts? Any color on kind of what's driving that really strong volume growth to 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. 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, 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 cheap swam for that NICU setting will 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 it's 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.

And if I could sneak one last one in the CMS program you talked about in the prepared remarks, historic guidance, as you called an 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 kind of covering it today? So, just give us a sense on 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'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.

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. 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 one follow-up.

Perfect. 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 to as 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 therapy. 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 is 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, 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. 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 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 when you got an answer. But thanks to the technology improvements and scale that we've been able to build into our business or 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 five have no out of pocket. And then because we're continuing to resolve variance 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 technologists about why they should use genetic testing versus other modalities that are inconclusive and continue to drive costs in the health care system and why we are easier to work with.

That's really helpful. And where -- 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 ologists, who has a child with a seizure is getting a genetic test. So, as we've talked about the total addressable market and the outpatient said anything 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 trial who has several of these symptoms, whether it is persistent seizures -- is it is milestones. It's usually a combination of multiple different types of symptoms that are showing up. That genetic testing being 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 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 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. 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 benefit 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. So, 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 that are partnering with us in 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 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 how it relates to cash burn? And then secondly, when do you expect to commercially launch your exome product to newborn. 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 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 -- so that would include GeneDx, Alumina, 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, alumina providing reagents, GeneDx providing the actual sequencing and interpretation and so our labor and know-how effort there, each contributing what we do best at, frankly, within no cost to the families involved in this.

In terms of timing and payer strategy, one, I want to reemphasize some of the comments that we made that the absence of this testing is indeed bundling children through this multiyear 6- to 8-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, it's 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. More than 70% of parents enroll in the 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 of 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 US. There's great evidence on clinical action-ability 4% is what we're seeing. But the business problems that we have to solve, that's what we're really good at, at GeneDx. 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 5-plus year time frame 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 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?

Yes. Maybe one way I contextualize, Mark, is we're still at a point where our payment rate is in the mid-50s and certainly believe the mature product in our space over time. One that we believe fills a large unmet medical need and really make 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 form, which will 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 -- improvement there.

Awesome. And then last one for me. It's for you, Katherine. 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 loves 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 exult 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 and others on the cardiovascular side of things. And again, taking a look at where biopharma companies are investing -- are investing their capital as well. So, we're going to work 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 with 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 a -- 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, and 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 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 population.

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. 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 to profitability from that revenue coming in year-to-date?

Yes, as you pointed out, there's about $6 million of estimate true-ups, although I've put that in the context of true-up spending a number of months or actually quarters. And the way I would think about it is that the GAAP 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 you view sort of the rev rec rate of $3,100 that you can 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. Maybe something you called out. But would this be -- 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 wanting 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. 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 setting the lower negative gross margin test and really staying focused on test that one, provide the best patient care to ensure that there is healthy gross margin and we'll continue to wind down task Kevin mentioned in the fourth quarter, continuing to have an eye for 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 2-test menu in exome and genome, ultimately running everything SAS genome for all. So, -- we do want to get to that place over time, but again, making sure that there's a clear reimbursement pathway.

Yes. The only thing I'd add to that, Matt, is, as Katherine said, returning 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-exnome, 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 coromosonal micro-array 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 breakeven. With we think a path to further improve upon that. So, a lot of rigors going into what is the remaining test menu, as Katherine 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.

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 relations on crops in the profitability line. How should we think about incremental investments over the next six to 12 months and 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 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 pets, 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 Buccal swab. We will have a 5-day turnaround time, and we will have repeat expansions. So, is 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 a really healthy business. So, 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 and really deliberate and methodical way moving forward.

Yes, maybe just to layer on 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 bringing 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, gross profit outpaces 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? And 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. So, the 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.

And our next question will be coming from Matt Stanton 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 mix 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?

Yes, 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 COGS stack, about a third of it resides in what I'll call the dry side processes. So, after the sequencer book 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 '25 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?

Yes. A typical lag of one to two quarters is not unreasonable. And so, I would really expect more of a '25 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.