Good day, and thank you for standing by. Welcome to the GeneDx Third Quarter 2023 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker’s presentation, there will be a question and answer session. [Operator Instructions]. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Sabrina Dunbar at GeneDx. 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, 2023. 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 30, 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 2023 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. We have a lot of news to cover on our call today, so I’m going to jump right in. Our third quarter results were strong with $53 million in revenue, gross margins of nearly 50% and a 52% year-over-year reduction in cash burn. We also saw the highest mix of exomes as a percentage of total volume coming in at nearly 30% in September. Our industry-leading exome and genome dove almost 2/3 of our revenue this quarter, and we continue to grow the market and offer clinical insights to more and more patients. And at the same time, we are materially reducing our cost structure in effective and scalable ways. The fundamentals of our business have never been stronger. We have organized our entire team around three major efforts: one, increasing exome and genome volumes; two, reducing claim denial rates to increase revenue per test and three, driving down our cash burn. Our exome focused strategy is taking hold. Our goal is to transform the market from single gene tests, multi-gene panels and microarrays to exomes and genome. And with exome representing 63% of our revenue in September, we’re well on our way. This quarter, we saw a 12% increase in the number of clinicians ordering exomes in the outpatient setting with the fastest-growing clinician count coming from neurology, representing 18% quarter-over-quarter growth. Pediatric neurologists continue to make up the largest portion of our new ordering clinicians. The building markets takes time. This year, we had our sights on an aggressive growth trajectory in the second half of the year centered around a faster conversion of single and multi-gene tests to our exome business. With $50 million in core revenue in Q3, we expect continued growth in Q4 and full year revenue now in the range of $187…

So I’ll repeat what Katherine said, it was a strong quarter. Total revenues were $53.3 million for the third quarter of 2023. Revenues from continuing operations were $50.4 million compared to $47.2 million in the third quarter of 2022 and $45.2 million in the second quarter of 2023. Excluding a onetime appeal benefit in the third quarter of 2022, revenues increased 14% for this third quarter. Whole exome and genome volume this quarter was over 13,000 tests, which represents a 71% increase year-over-year, an 11% increase compared to the second quarter of this year. We generated $34 million this quarter from exome and genome testing, a 42% increase year-over-year and 18% compared to the second quarter of this year. Adjusting for the same onetime appeal benefit in the third quarter of 2022, revenue specific to exome and genome increased 61% year-over-year. In the third quarter of 2023, adjusted gross margin from continuing operations was 48%, up from 37% in the second quarter. The margin expansion is coming from 3 places. The first is Test Mix. To level set, our adjusted gross margin for exome remains over 60%. Exome and genome represented 23% of all tests in the third quarter with a high of 28% in the month of September. Total gross margins will continue to benefit as exome picks up more share of our overall test production volume, replacing lower margin and, in some cases, negative margin products. The second is on cost per test. We now have 2 lower cost per test Illumina X Plus machines live, and we will aim to replace the remainder of our APS legacy NovaSeq fleet at the right time over the next several quarters. We also have recently received our first PacBio Revio machine. Beyond our long-read sequencing collaboration, the team here is…

Our commitment to turning to profitability in 2025 is our unquestionable focus. As we’ve commented today, that is possible with growth, efficiency and cash management and our planned support to these 3 drivers. In managing the business to this goal, we are well positioned to lead the market to diagnosing all inheritable diseases with our exome and genome backbone and ultimately realize our vision of using genomic and clinical data to inform disease diagnosis, treatment selection and to accelerate drug discovery and development. For now, by focusing our business on exome and genome we will drive value creation for our shareholders while continuing to serve more and more patients. Now we’ll turn it back to the operator for Q&A.

Thank you. [Operator Instructions] Our first question comes from the line of Dan Brennan from Cowen, your line is open.

Hey this is Joe for Dan. It seems like the exome volume growth story and the mix shift is really playing out with 70% exome growth in the quarter and 28% mix in September. So what’s -- what do you see changing in the fourth quarter that’s bringing down the implied Q4 guide?

Yes. Joe, look, I think the way we view it is we did add some new team members to the commercial field force, and that’s in large part what is driving the growth in the exome portfolio. We’re really happy with how the quarter played out. We’ve seen some pretty substantial growth in both Q2 and Q3. And so the guide is really reflective of what we see line of sight to. October is coming in strong. We’re pleased with the data thus far. We do typically see a Q4 uplift in terms of ordering patterns and ASPs. We would expect that. And so I have every confidence that we can hit the high end of that range. But the previous guidance range that we provided particularly at the higher ends of that, we just fell short in the first couple of quarters of this year. Really happy with how the second half of the year is progressing here. So the guide really was just reflective of how the earlier part of the year played out.

Got it. And then on ASPs, it looks like they came down about 15% in Q3 on a blended basis. Do you see pricing generally stabilizing into ‘24? Or do you expect these kind of like 10% to 15%-ish year-over-year quarters to continue?

No, I think we view Q3 as a baseline from which to improve on. If you just focus in on exome, we did see improvements in Q3 versus the second quarter with an average of just north of $2,500 versus the second quarter in the $2,400 range after all denials. We’d expect a similar progression in the fourth quarter with a slight uptick in the fourth quarter. And as we mentioned in our remarks, we’ve got teams nearly across the entirety of the company focused on improving front-end processes to bring down the denial rate and would expect that over the next several quarters, you’d see incremental ASPs improvements in exome. On the other product lines, we’ve identified some near-term opportunities in particular with chromosomal microarray in hereditary cancer. Frankly, those are 2 product lines that had not received as much focus in the past couple of years as they maybe should have. So the team working on improving [Zeni] rates on those 2 product lines, in particular. Outside of exome and CMA hereditary cancer, you might expect blended ASPs on the other panels to stay flat, on a go-forward basis.

The only thing I would add to that, and I think the way that Kevin framed it in terms of finding opportunities beyond the exome since we saw a nice increase in exome. We are going to be retiring about 350 tests in early 2024. So again, continuing to really focus the business on the test that differentiate us that are best for patient care and that can have a positive impact on the P&L as well.

Got it. And then just last on the $40 million incremental cost out. Where are these coming from? And just kind of can you talk about where we’ll see this in the P&L would be great.

Yes. About half is coming from employee reductions. We took some actions midway through the third quarter and then today, impacted another subset of employees with a fairly sizable reduction in force throughout the day to day. The group’s impacted there, primarily research and development, some product and technology and then other support functions as frankly, as we’ve gotten further away from separating Sema4, the overall support necessary for the go-forward business is titrating down. And so we’re reacting as quickly as possible to right size the cost base as we move further and further away from that shutdown. And those shutdown activities are now complete. As it relates to the remainder of the spend there, we’ve taken a focus on really earning our way to longer-term pursuits around research and development. And so reductions with respect to projects that would have longer-term payoff, I think 2026 and beyond. And so feel confident that everything necessary to grow the top line to expand gross margins still remains intact, and it’s those longer-term pursuits with respect to R&D that have been trimmed down.

Thank you. One moment for our next question. And our next question comes from the line of Mark Massaro from BTIG, your line is open.

Hey guys, thank you for taking the questions. I know you addressed that most of the $40 million annualized cost reduction is coming from R&D and support functions. But were there any reductions to the sales force or MSL crew. I think based on my notes, I think you are planning to onboard 10 new reps in the second half of this year and finish somewhere in the 65% to 70% range. Can you just maybe update us on the size of the commercial organization?

Yes. The commercial organization is going to continue to be an area of investment for us. So for the most part, I would say the removal that we try to do very surgically ensures that we are not eliminating any rules that will slow down growth or will impact the integrity of the product. So we feel really confident that the quality will remain high and ensure that we can continue to be the market leader and that we can continue to drive meaningful growth through the commercial organization. So no impact on sales force, no impact on MSLs. Those 2 teams and the commercial functions supporting them are critically important and have been doing a fantastic job this year, as evidenced by the results of the quarter. The sales force, we’ve got, I think, about 62 of those roles filled right now. So close to being at capacity. We always expect that there’s going to be a handful of roles that are open from time to time. And then we do have our team of MSLs that are fully staffed, they were just gathered in Gaithersburg last week, I had the chance to talk with them. So they are continuing, I would say, as we look towards the future commercial strategy to really hone in on working collaboratively as a team looking at overall account profitability and keeping focused on ensuring that we can continue to drive exome and genome moving forward, and those MSLs are critically important to our ability to do that.

Okay, thank you for that. So I’m still not understanding why you lowered the full year guidance. I mean I understand that, you needed 60% of your revenue to come in, in the back half of this year. We were modeling below your guidance, but still, the implied Q4 is still very significantly below the Q4 consensus revenue estimate. So maybe can you just walk us through what has changed? I understand that you have been onboarding new reps, I assume maybe their initial traction in Q3 wasn’t as high as you expected. But what else is going on in terms of pricing, in terms of work with payers. I would assume that some of your prior guide would have required more work from payers. So can you just broadly give us an update on traction with commercial pay, maybe the timing of some of the new plan coverage and maybe some of the onetime payments that you might have expected in your prior outlook.

Yes. I think Mark, it’s a little less around payers and pricing. In fact, we are fairly optimistic that we’re -- the data in the last two months and including through today, through October from a reimbursement and denial perspective is improving and is starting to show payoff from the efforts we’ve put in place around revenue cycle. If you go back to the original guide, it anticipated that, in particular, at the tail end of the second quarter and beyond, we would start to see a fairly sizable ramp in conversion from chromosomal microarray into exome. We had previously talked about bringing on some of those CMA tests as stepping stones or seeds for future exome. And as the commercial team has been out executing, we’ve added the MSL teams to engage in conversations I think we -- what we’ve seen is that we should expect a more moderate conversion ramp from CMA into exome than a massive bolus of conversion or inflection point, really anchored on a few things. One, physicians -- long-standing physician behavior. We’re just encountering docs who’ve been practicing genetics for the same way for quite a long period of time. And we have education to do with respect to misperceptions in the marketplace with respect to these tests, that they take months and not weeks. We’ve got our rapid exome product down to a verbal report in 3 days. And so old perceptions around turnaround times, old perceptions around pricing. And the noise that might be in a report with respect to variance of unknown significance are all things that we’re seeing entrenched behaviors and mindset among physicians, and we’ve seen a flattening of that conversion ramp versus previous expectations. So is the primary driver. That said, the exome portfolio has grown rapidly, and we’d expect pretty similar growth rates going forward. So the go-forward guide for the fourth quarter, we just posted a plus $5 million revenue quarter from Q2 to Q3, and we’d expect something similar in the fourth quarter as we’re starting to see a normalization of what we can expect in terms of that CMA to exome conversion.

Okay. That is helpful. So it looks like the midpoint of your guide would imply about 10% or 11% revenue growth for the full year. Recognizing that you are picking up a higher mix from exomes. Is it reasonable as we think about our models for 2024 that greater than 10% should be readily achievable. But any other granularity or commentary about the levers of growth in ‘24 would be helpful.

Yes. I mean -- so we’re not providing full year ‘24 guidance. We’ll do that in early January. But tried to outline for you in my prepared remarks, and there’s a page in our earnings materials as the deck we posted to our website really to sketch out what we believe is an illustration of the path to profitability. And believe firmly we can get there to breakeven and beyond, even if you assumed year-over-year revenue growth of around 20%. And if you think about the go-forward base, all of our growth is really going to come from the exome portfolio, which just grew well in excess of that mark. And so I really believe that you should expect similar exome growth year-over-year moving forward. If you recall, this year was impacted earlier from some price concessions we offer to the marketplace at the end of next year. So that played with the year-over-year growth rate some. That’s all worked through the system and believe at this point, you should expect on exome only sequential ASP improvements moving forward. So we might expect a greater growth rate year-over-year from 23% to 24% than what we posted this year.

Okay. That’s helpful. And if I can sneak one last one. The adjusted gross margin from continuing ops of 48%, that was strong and well above our modeling. Do you think that’s perhaps a level that you can build off from here? Or were there any one timers in Q3?

Yes. We do think it’s a new level or a base to work off of. There were no meaningful onetime items in that number either in terms of ASPs revenue or COGS. To your point, we are seeing some efficiency initiatives take hold and provide results ahead of schedule. I tried to call out a few in my opening remarks. But yes, we’ve outperformed in the cost per test, in particular, cost per test around exome and think that those efficiency gains are here to stay.

Okay. That’s it from me. Thank you

Thank you. One moment for our next question. And our next question will come from the line of Brandon Couillard from Jefferies, your line is open.

Thanks. This is Matt on for Brandon. Maybe sticking with gross margin there. I appreciate all the color, Kevin. In terms of the 3 buckets you spiked out for the sequential improvement in gross margin, should we think about each one of those kind of having a similar contribution? Or is there one in there that kind of was an outsized driver to the improvement here we saw in 3Q?

It’s really the -- I would say, take them in the relative order that I outlined with cost per test leading the way there. And those are coming from a number of areas, both in the wet and dry side of the laboratory. Some are process related, some are technology related. The new machinery from Illumina is paying off as expected. I think what gives us the most comfort and conviction moving forward is we’ve got a large road map going forward of additional efficiency items that are near-term line of sight and can be relied on. And so we’re only just getting started in driving down cost per test of exome. That one probably leads the way, and you can take them into ranked order in which I outlined.

That’s helpful. And then I appreciate all the color on the cost outs. I just wanted to ask, so $40 million of further cost outs reiterated your profitability target for 2025, so not pulling it forward on those or anything. I mean are we supposed to think about that when that profitability of custom comes it could be more meaningful given the additional $40 million that’s coming out today or just trying to get hands around using the profitability target now pulling it forward, but taking another $40 million out of the cost structure, thanks.

Yes, I think the marker of 2025 acknowledges that the revenue base came in a bit lower than expected for this full year. The $40 million really meant to ensure we meet the commitment we made, which was to turn this company profitable by the end of 2025. We’re more convicted today in our ability to do that. Frankly, we found more efficiencies as part of a recent review than we thought we might on the outside -- outset of that analysis. I think any upside to be able to pull profitability into 2024 would come from outsized revenue growth, which, of course, we’re aiming to achieve, but wanted to be careful not to overpromise.

I guess, last one maybe for Katherine. You guys have made a lot of changes on the commercial side, working on new territories, new outreach programs, things like that. Maybe just talk a little bit about what needs and hire for your Chief Growth Officer, should we expect any kind of change or additional things there in the commercial side or more just kind of a continuation of some of the moves you guys have made so far this year? Thanks.

Certainly. So just added Melanie Duquette, who joined in September to lead the overall commercial strategy to working off of a strong foundation that we have in place, I think, to take us to kind of the 2.0 version of where we want to go in terms of commercial efficiency. So really, what we expect is, I would say, the cross-functional teams that are focusing on growth and on account profitability, to be really working more efficiently together. So I would say she has done a tremendous job when she was at her prior company, really shifting the focus from volume to keeping the team focused on volume on revenue, on ASPs and overall account profitability. So I would say that’s what we’re looking for in terms of the shifts moving forward and just some continued improvement on overall efficiency and ensuring that those teams that we’re working with are working in a more singular way and support of account growth. So continued focus on opening up markets but doing it in a way that will align with our P&L, and we’ll continue to focus on delivering on good patient care.

One moment for our next question. And our next question will come from the line of Matt Sykes from Goldman Sachs.

This is Prashant Kota on for Matt. What split do you see between inpatient and outpatient exome testing? And do you see that evolving over time?

Hey Prashant. Yes. So the vast majority, I think 97%, 98% is in the outpatient setting today, really predominantly focused on exome versus genome in outpatient setting. I would say though that the rapid setting in the inpatient, which is primarily a utilization of our rapid genome product, that is growing quickly. It’s just a very small portion of the business. I think that’s going to fall into the category of longer-term market building. There’s a lot of fundamental dynamics that we have to continue to work through in order to drive utilization. That being said, we just had a really nice win at a health system in Florida, where we’ve been able to get institutional contracts set up to be able to drive utilization of our rapid genome in the NICU. So I’m encouraged by some wins like that, that ensure that, that product is being utilized. The vast majority of the inpatient is institutional pay. So that’s obviously one barrier that we have removed both for utilization and also for us. We get paid 100% of the time on those. So we really appreciate that business. But we continue to view that as being a longer pull in terms of driving utilization. That’s going to take some more time. So as we think about the breakdown over the next several years, we’re still going to see it predominantly in that outpatient setting.

Got it. Thank you. And then can you just talk about your progress in reducing claim denials and specifically, what percent of claims are not approved if you have that number? And roughly how long is the appeals process?

Yes. So as we talked about, we did bring in a bunch of new folks really to take a look at our end-to-end processes, in particular on the front end of claims submission. So a lot of work is ongoing, and we did see an uptick in ASPs. That’s all driven by a slight reduction in the denial rate this quarter. So pleased with the initial finding, certainly a long way to go there. I think it was just important to get fresh eyes on our processes. And we really feel confident that much of the denials are addressable. To your question, north of 60%. So low 60s is our denial rate today on the exome portfolio. That hasn’t changed in a while, although we did improve about 1 percentage point in the third quarter versus the second, and that’s what drove the incremental uptick in average ASPs. I think longer term, you should expect us to take incremental bites out of that denial rate with each passing quarter as the effects of the ongoing work begins to take hold. The appeal process themselves -- itself is lengthy with really us going back to payers to re-adjudicate claims based on the medical necessity and unique circumstances of patients. We have an appeal process stood up today, but I think more important to driving down denials and improving ASPs and therefore, revenue comes from avoiding denied claims, and that’s where all of our effort is focused at the moment.

Got it. That makes sense. And if I could squeeze one last one in. How are you thinking about capital allocation given the new capital you’ve raised with the debt agreement?

Yes. I think we -- the way we look at the new debt agreement is to couple it with the cost reduction actions that we took today, which, as I mentioned, the reductions really placing an emphasis on three main priorities for the company. How do we drive exome growth? How do we improve exome reimbursement by reducing denials and then how do we find cost efficiency and reduce costs elsewhere to improve the financial health of GeneDx to meet that commitment to become profitable sustainably in 2025 and beyond. And so all of our available capital is allocated to supporting those three pursuits with any capital allocated to R&D and product and technology to find ways to help the company get more efficient to drive down exome costs.

Okay. Thank you.

Thank you. And that will conclude Q&A for today. I would now like to turn the conference back to Katherine Stueland for any closing remarks.

Great. Thank you. We have a strong and growing business, a commitment from the management team to continue to do it as efficiently as possible. And we are grateful for the continued support of our shareholders and look forward to seeing many of you at an upcoming conference. Thank you.

And this concludes today’s conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.