Veracyte Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 24, 2025

There are 12 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Veracyte Fourth Quarter and Full Year twenty twenty four Financial Results Webcast. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Call.

Operator

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Shayla Gorman, Senior Director, Investor Relations. Please go ahead.

Speaker 1

Good afternoon, everyone, and thank you for joining us today for a discussion of our fourth quarter and full year twenty twenty four financial results. With me today are Mark Staffley, Veracyte's Chief Executive Officer and Rebecca Chambers, our Chief Financial Officer. Veracyte issued a press release earlier this afternoon detailing our fourth quarter and full year twenty twenty four financial results. This release and a copy of the presentation we will review during the call today are available in the Investor Relations section of our website at veracyte.com. Before we begin, I'd like to remind you that various statements we make during this call will include forward looking statements as defined under applicable securities laws.

Speaker 1

Forward looking statements are subject to risks and uncertainties, and the company can give no assurance they will prove to be correct. Additionally, we are not under any obligation to provide further updates on our business trends or our performance during the quarter. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that VeriCite files with the Securities and Exchange Commission, including Veracyte's most recent Forms 10 Q and 10 ks. In addition, this call will include certain non GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures are included in today's earnings release accessible from the IR section of Veracyte's website.

Speaker 1

I will now turn the call over to Mark Staffley, Veracyte's CEO.

Speaker 2

Thank you, Sheila, and thanks everyone for joining us today. 2024 was a record year for Veracyte. I could not be more proud of our team for their hard work on behalf of the patients we serve, which is the reason we come to work every day. Not only did that focus and dedication lead to approximately 150,000 patients benefiting from the information provided by our tests, it also enabled us to execute on our key strategic objectives and deliver a best in class financial profile. We capped off a record year with Q4 revenue totaling $119,000,000 or 21% year over year growth.

Speaker 2

This brought full year total revenue to $446,000,000 for robust growth of 23% year over year. Testing revenue, which now accounts for almost 95% of our business, grew 28% year over year. Fourth quarter testing revenue increased 24% over the prior year and marked our tenth consecutive quarter of 20% or greater testing revenue growth, demonstrating the durability and runway of a firm and decisive that we have consistently signaled. And we drove class leading bottom line performance, delivering full year adjusted EBITDA margin of 20.6% and cash generation of more than $70,000,000 Starting with DECIPHER, we further strengthened our position as the market leader with outstanding adoption over the course of 2024 as we delivered more than 80,000 tests, representing volume growth of 36%. During the fourth quarter, DECIPER volume grew 45% year over year to a new record of more than 22,400 tests.

Speaker 2

We are particularly proud of our land and expand approach in prostate cancer, which has enabled us to go from an early beginning in RP only to adding biopsy almost a decade ago and growing that to be the vast majority of our testing today. In Q4, we saw 40% to 55% annual volume growth across each of the NCCN biopsy risk categories from low risk to intermediate risk and high risk. Importantly, low risk now represents an impressive 20% of our total Decipher volume. This is a testament to the value that DECIPA brings to this population in better managing their disease from those that will benefit from active surveillance to those who have a worse prognosis and might need treatment. As a demonstration of the clinical utility of DECIPA in the NCCN low risk population, based on our extensive real world evidence about a third of those patients are reclassified to DECIPA intermediate or high.

Speaker 2

DECIPHER's clinical validity and utility has already been demonstrated in approximately 85 clinical studies. This includes 42 on biopsy samples, more than a dozen of which could inform an active surveillance decision and 43 on radical prostatectomy. Since our last earnings call, we added 20 new publications, posters, abstracts and presentations highlighting the clinical utility for DECIPA as well as incremental disease insights powered by DECIPA grid. Looking ahead to further the CIFAR catalyst, we now estimate the growing prostate cancer market is approximately forty percent penetrated and we believe we have more than 65% market share, which we estimate increased by more than 500 basis points over the course of 2024. As we have previously shared, our goal is to drive at least 80% market penetration in all of our indications.

Speaker 2

With the 2025 updated NCCN guidelines for prostate cancer, Defyper is still the only gene expression test with Simon level one evidence and we believe it's now the only gene expression test that is recommended by the NCCN panel to make personalized treatment decisions for prostate cancer patients. Now to expanding DECIPHER to cover the entire risk spectrum for patients with prostate cancer. Our metastatic technical assessment was approved in late December and we secured New York State approval in January. We are well on our way to finalizing all the necessary commercialization and training activities to launch into this expanded population in the first half with volumes benefiting in the back half of twenty twenty five and beyond. Given our leadership position, the expansion of DECIPA into the metastatic patient population, as well as significant greenfield opportunity ahead for our test in localized disease, we expect to drive meaningful DECIPA growth for the foreseeable future.

Speaker 2

Moving to Afirma, volume growth continues to be very strong and increased 12% in 2024. Despite the challenging Q4 comp, we delivered more than 16,300 tests during the fourth quarter, growing 8% year over year, while revenue grew 4% given the large prior period collection in the fourth quarter of twenty twenty three. Deeper penetration into existing accounts along with some sizable new customers drove the majority of growth in the quarter, a testament to Afirma's differentiated level of evidence, service and overall performance. As a reminder, an expanded LCV for Afirma went into effect in July 2024, adding reimbursement for Medicare and Medicare Advantage patients with Bethesda five thyro nodules. Revenues for Bethesda five and six grew more than 80% year over year in the fourth quarter.

Speaker 2

We expect this to be a moderate ASP tailwind in 2025 as the clinical utility is further developed and resonates more with physicians. Meanwhile, the research use only GRID data is driving interest in evidence generation from the KOL and academic community. We look forward to sharing a number of upcoming publications and poster presentations leveraging this data in 2025 as we continue to build on our commitment to patients and physicians to advance thyroid cancer research. The endocrinology market is still only about 65% penetrated as of the beginning of twenty twenty five and we estimate is growing in the low single digits. We believe Afirma grew share in 2024, continues to serve the majority of the market and will make gains in both share and penetration to deliver strong revenue growth of high single digits this year.

Speaker 2

We are confident that DECIPHER and AFFIRMA have ample growth runway ahead to bridges to our longer term growth drivers, which I will discuss next. First, I'll start by providing a quick update on the status of our Nightingale study for nasal swab. To date, we have enrolled more than 85 of the 2,400 patients that we are targeting and look forward to sharing when enrollment is fully completed. Next, I'd like to provide an update on our efforts to serve more of the patient journey through MRD and recurrence testing. Our MRD approach is differentiated in the whole genome every step of the way, including the initial baseline sequencing followed by the sequencing of serial testing samples.

Speaker 2

This approach is backed by our fundamental belief that more data drives more insights, more clinical evidence, more payer coverage and therefore more durable adoption. As we have shared, we are working on the first indication of our MRD platform for muscle invasive bladder cancer. This indication will leverage our strong decipher channel that serves urologists and radiation oncologists. We are also focused on expanding into other indications where we already have a commercial presence. We have completed setting up the workflow in our lab and submitted for New York State approval.

Speaker 2

Further, we recently submitted to MolDX our proposed Z codes and expect to submit our tech assessment this quarter. These are critical steps for us to be able to launch and we're pleased with the progress we're making. As is our strategy across our platform, we are committed to having reimbursement in place and all development managed care and commercial activities are progressing well so that we can launch our inaugural MRD test in the first half of twenty twenty six. Finally, turning to our longer term strategic growth driver of international expansion. Here we are dedicated to launching our tests as IVDs to address patient needs outside The U.

Speaker 2

S. As you know, our French subsidiary Veracyte SAS or SAS has been focused on supporting our IVD strategy as well as a legacy biopharma and third party contract development manufacturing business. Given the declines in biopharma and our manufacturing supply challenges for Prosigna, we believe that to continue to support such a large operation and infrastructure may be inconsistent with our core strategy and may not be in the best interest of Veracyte. Given this, we notified SaaS that Veracyte Inc. Is considering no longer funding their operations.

Speaker 2

As a result, SaaS will engage in consultation proceedings with the Work Council over the coming months, while in parallel seeking to identify one or more buyers for all or part of the SaaS activities. Without Veracyte Inc. Continued funding or identification of a buyer, SaaS may be required to commence bankruptcy proceedings this year. Consequently, Veracyte Inc. Would no longer own or operate the Marseille facility by year end, if not sooner.

Speaker 2

Our first priority is to our patients and so we will do our utmost to maintain continuity of Prosigna nCounter supplies for the foreseeable future, which will depend in part on finding a buyer for this portion of the business. Further, we remain committed to our IBD strategy and our ongoing development programs. Having said that, this potential change is expected to impact our timelines and we are diligently reassessing our development roadmaps. In terms of the financial impact this year, this is of course highly dependent on the final outcome and the timing of that. Rebecca will share what she can to help you bracket the potential impacts.

Speaker 2

Our Marseille team has worked hard on behalf of customers and patients and I truly appreciate their efforts. As we always do, we will compassionately support our employees during this information and consultation period. Despite these challenges in what is now a very small part of our business, I don't want to lose sight of the success we are having in the core business. As you can see, Q4 was another incredible quarter that capped off a truly exceptional year for Veracyte. My sincere thanks to our team for their relentless focus on our mission to serve patients.

Speaker 2

It is their hard work that sets us apart as we transform cancer care for patients around the world. This year, we are committed to continuing to deliver robust testing revenue growth as we execute on a number of key catalysts that will expand our reach both further along the patient journey and geographically. We look forward to sharing more details with you as we progress towards these goals. With that, I will now turn to Rebecca to review our financial results for the fourth quarter and full year 2024 as well as our outlook for 2025.

Speaker 3

Thanks, Mark. As mentioned, Q4 was a strong conclusion to 2024 as we delivered revenue of $118,600,000 an increase of 21% over the prior year period. Further, total volume grew to approximately 41,000 tests, a 22% increase over the same period in 2023. Testing revenue during the quarter was $112,200,000 an increase of 24% year over year driven by DECIPHER and AFFIRMA revenue growth of 444% respectively. Total testing volume was approximately 39,100 tests.

Speaker 3

Testing ASP was approximately $2,875 which included approximately $600,000 of prior period collections. Adjusting for the impact in the quarter, testing ASP would have been approximately $2,850 up 4% compared with the prior year period. Turning to the product line, fourth quarter volume was approximately 2,200 tests and revenue was $3,000,000 down 18% year over year as we continue to experience supply and manufacturing challenges, while also managing demand for Porcigna. Biopharmaceutical and other revenue was $3,500,000 down 17% year over year. Moving to gross margin and operating expenses, I will highlight our non GAAP results.

Speaker 3

Non GAAP gross margin was 69.3%, down approximately 130 basis points compared to the prior year period. Testing gross margin was 72.3%, down approximately 150 basis points due to the impact of approximately $4,000,000 of lower prior period collections compared with the same period in 2023. Product gross margin was 7.3% down materially from the prior year period due to lower fixed cost absorption and manufacturing challenges. Biopharmaceutical and other gross margin was 26.5%, up 9.4% year over year. Non GAAP operating expenses were flat year over year at $57,900,000 Research and development expenses increased by $200,000 to $17,400,000 given personnel additions from our C2I acquisition and increased development costs, partially offset by the NextSeqDX IVD technology access fee that was recognized in Q4 twenty twenty three.

Speaker 3

Sales and marketing expenses increased by $200,000 to $23,000,000 G and A expenses were down $300,000 to $17,600,000 driven by lower compensation expense partially offset by infrastructure investments. Moving to profitability metrics, our financial profile continues to be best in class driven by our disciplined approach. In the fourth quarter, we recorded GAAP net income of $5,100,000 and delivered adjusted EBITDA of $26,100,000 or 22% of revenue. Full year 2024 adjusted EBITDA margin was in line with our guidance of over 20% at 20.6%. We ended 2024 with $289,400,000 of cash and cash equivalents generating over $70,000,000 of cash driven by $75,000,000 of cash from operations.

Speaker 3

During the fourth quarter, we made an election to treat Veracyte SaaS as a disregarded entity for U. S. Federal income tax purposes resulting in a $356,000,000 worthless stock deduction. Given this, our Q4 GAAP effective tax rate was minus 48.5%, our full year 2024 tax rate was 6.2% and exiting 2024, our NOLs available to offset offset U. S.

Speaker 3

Future income now stands at more than $600,000,000 Before moving to our outlook for 2025, I would like to provide you with additional information regarding the France business. Please bear in mind that we are subject to a strict legal process and so are somewhat limited in what we can share. Biopharma and other revenue now runs at about $2,000,000 per quarter as does product revenue. Our fixed cost structure in France runs about $7,000,000 per quarter and our net operating losses are approximately $5,000,000 per quarter. Revenue could be negatively impacted anytime depending on our ability to continue servicing current customers including through Prosigna production.

Speaker 3

Meanwhile, our cost structure will be positively impacted in the future if SAS completes a sale to a potential purchaser or finalizes bankruptcy proceedings. The timing of these events could occur in different quarters or not at all. This year, we are currently estimating one time costs of up to $15,000,000 Going forward into 2026 and beyond, if this goes ahead, we would see an improvement in our annualized profit of approximately $13,000,000 Looking ahead to 2025, given the dynamic nature of the situation with our French entity, our guidance will highlight testing revenue and total company adjusted EBITDA margin for the year. We are forecasting testing revenue of $470,000,000 to $480,000,000 or 12% to 15% year over year growth. As a reminder, and as we shared on our Q3 call, we made the difficult decision to pause offering the Envisia CLIA test at the end of twenty twenty four.

Speaker 3

Adjusting for the approximately $6,000,000 revenue impact, testing growth would be 14% to 16%. For 2025, we are forecasting adjusted EBITDA margin to improve by approximately 100 basis points as we balance investment in organic revenue opportunities for long term growth with enhancing our already best in class financial profile. Our guidance assumes 2025 GAAP and non GAAP tax rate will be in the mid to high single digits. Turning to the first quarter, we expect testing revenue to step down from Q4 given the firma seasonality as well as lower product and biopharma revenue. With the annual reset of taxes and merit as is typical, we expect Q1 adjusted EBITDA margin to be in the mid teens.

Speaker 3

Further, due to standard first quarter personnel costs, we plan to use cash in Q1 before generating cash over the remainder of the year. In closing, I am proud of the tremendous strides we made in 2024 and, together with the entire Veracyte team, committed to delivering to the strategic priorities we've set in 2025 and beyond. Further, I'm proud of this organization's focus on delivering what is best for all stakeholders. We do our best to balance this each and every day with patients as our purpose. We'll now turn to the Q and A portion of the call.

Operator

And our first question comes from Doug Schenkel with Wolfe Research. Your line is open.

Speaker 4

Good afternoon, everybody, and thank you for taking my questions. I have two and I will just rattle through both of them here and then get back in the queue. The first is a higher level question. 2024 was a really strong year for the company. You set testing expectations for 2025, taking out all the adjustments at levels that I think were well ahead of consensus expectations.

Speaker 4

So in many ways, you're in a position of strength in what is a tough environment for the broader market and the group. I'm just wondering, Mark, if you would talk a little bit about how you balance the potential to maybe get more aggressive with either further investment in growth and or capital deployment with really the desire and the need in this environment to continue improving margin and cash flow? How are you balancing those options and those levers you have to pull? So that's the first topic. The second is for Rebecca.

Speaker 4

Rebecca, I think the assumption for a firm of revenue growth is high single digit growth this year. I think that's what's embedded into guidance. Assuming I have that right, how much is expanded LCD coverage versus pricing or other levers contributing to growth within the Afirma franchise this year? Thank

Speaker 2

you. Great. Thanks Doug. Appreciate questions. I'll take the first one and Rebecca will take the second.

Speaker 2

So yes, I appreciate you pointing that out. I mean, the twenty twenty four has been an incredible year and it's clear it's driven by our core testing business and the growth of DECIPHER and AFERMA. We've been signaling for quite a while now that both products have plenty of runway. I cited the amount of that kind of opportunity there is in the market to grow each further, the opportunity is to take share even though we're coming from a position of strength there. And so we feel confident that those two businesses, that core franchise bridges us to our long term growth drivers.

Speaker 2

And we talk about three things that we're doing within the company, including our international expansion, our MRD platform and innovative tests like nasal swab. And of course, as you can imagine, we're working on other things as well. We're not ready to get into at this stage. But there's a lot of things that we're focused on as a company. And I think what you've seen us announced today with again another step in our kind of portfolio rationalization work and our difficult decision or rather than decision our recommendation or our desire to look at the further investment in France.

Speaker 2

We have continued that portfolio process. And as a consequence, if that goes ahead at some point, that might create opportunity for us to invest in other ways. And so this portfolio decision making process that we go through has been key to create opportunity, so that we can both focus our company and focus our team and focus our investment in things that we think are going to drive a positive ROI for the company in the next few years, five years and even ten years. So we think very long term at Veracyte and we're excited about the opportunities we have. Capital deployment is one legal we have as well.

Speaker 2

Obviously, coming from a position of strength in terms of generating positive cash flow gives us even greater opportunity there. So lots for us to do, but right now our team is very, very focused on things that are right in front of us. We have to get through this consultation period with France. We have to get MRD launched. We have to get metastatic launched.

Speaker 2

We're doing things within the company to improve costs. There's a lot in front of us right now, all very positive things and one or two things that we just have to get through and let the dust settle.

Speaker 3

Absolutely. And the other thing I would just add is the benefit of the structure of our P and L allows us to both enhance multi year period while also investing for those growth drivers that Mark mentioned and others that have not yet been mentioned. So we're pretty excited about 2024 results, 2025 outlook and even beyond all is headed in the right direction. To that end, Doug, on your question on Afirma, effectively, yes, you're correct. Guidance does contemplate high single digit growth for Afirma.

Speaker 3

Given some of the given effectively the benefit of what we're seeing both competitively, incidence growth, as well as kind of share gains, we are driving most of that through volume. There is not a huge ASP tailwind assumed in the Afirma guide for the year. So I think we're going to kind of continuously play our playbook here for Afirma and that is continuously introducing product introductions, whether that's through customer experience or new grid signatures etcetera, get out there, pound the pavement, share what we're doing and execute as we have for that product for the last number of years now.

Operator

Thank you. Our next question comes from Mason Carricka with Stephens. Your line is open.

Speaker 5

Hey guys, thanks for the question. I'll just keep it to one here. When it comes to guidance, could you give us some color around how you're thinking about metastatic revenue this year? I know you talked about the back half, but any incremental color around cadence or potentially the opportunity to pull that revenue forward this year?

Speaker 2

Maybe Mason, I'll start and Rebecca can jump on in terms of guidance. But a reminder for everybody, the metastatic indication is thirty thousand new incidents of the year, which is about ten percent of them the total market. We're very deliberate about our choice of language there around the second half of the year. We've still got work to do to get this launched. The hardest part of actually getting everything ready and approved is very much behind us.

Speaker 2

Now it's a lot of just blocking and tackling internally to get it done. And then that then we've got to go out to customers and really talk about the benefit of this test for patients in that setting. And so in that regard, we're starting from ground zero there. And so you would expect to ramp as our sales teams do that. We also don't want to distract from a core localized business that's been growing fantastically as well.

Speaker 2

So how we meter those two things and balance those two things is a really important part of the equation. So given that we've been very deliberate about this being more of an impact in the second half and accelerating it wouldn't necessarily be in our best interest. We're thinking about the long term doing it right, launching it right, getting it right and having the most success with that for the benefit of patients.

Speaker 3

Absolutely. And on the guidance front, we have assumed a relatively small contribution, given it will be the first two quarters of launch for that 30,000 patient population. So I think could there be upside to that potentially, but I think the bigger upside driver would be outperformance during the year on the core DECIPHER business. That could obviously be a piece of it, but I think given our projections for where volume is coming from and where volume growth is coming from this year, metastatic will be a multi year growth driver more so than the second half of our 2025 growth driver. Nathan, if you don't mind, maybe perhaps we can go into some of the sequential trends for guidance for the year, given the highlight of the second half with metastatic that absolutely is the case.

Speaker 3

As is typical, we do expect Q1 seasonality. There's a couple of drivers to that. One is Afirma. Last year, obviously, we saw a step down in Afirma. We're expecting something similar this year.

Speaker 3

Also, we are not having going to have the benefit of Envisia revenue in the first quarter, which was around $1,000,000 in the fourth quarter. And then we did have a little bit more weather so far this year than we have had in prior years. The reason I cite this isn't because that has impacted order trends are actually quite strong, but it has impacted effectively three days of samples getting to us and we'll make that up within the first half, but it depends on whether or not weather kind of strains out from here on out whether we make it up in the first quarter or so. So just want to make sure you all have the benefit of that information. We're incredibly excited about this year for DECIFA for Afirma for kind of the strategic long term growth drivers and what we're setting up for here.

Speaker 3

So don't want to have some sequential trends be a surprise given those are effectively what we see every year.

Speaker 5

Got it. Thank you, guys.

Operator

Thank you. Our next question comes from Puneet Souda with Leerink Partners. Your line is open.

Speaker 6

Yes. Hi, guys. Thanks for taking my questions. First one, just given the puts and takes on the NCCN. And first of all, very strong quarter here in Decipher volumes.

Speaker 6

Just want to understand NCCN contribution versus other factors that are contributing to that? And how do you expect that to play out in 2025? You have the advanced table as well. And also in terms of overall the penetration of DECIPHER is a strong well established in the market. So just trying to understand how should we think about DECIPHER twenty twenty five and DECIPHER volume growth 2025 and longer term as well, given the status of this product with the strong clinical evidence behind it and metastatic also helping?

Speaker 2

Yes, thanks Puneen. You talked about the key point here is the evidence because the NCCN is really just a kind of a manifestation of the great evidence that you have for a product and that we have for DECIPHER. I'll start by saying, obviously, I appreciate the incredible amount of work that goes into the NCCN process. It's a group of very hardworking individuals to spend time understanding the evidence, making sure they can assimilate that evidence and provide guidelines that are in the best interest of patients. What's very clear is NCCN has, I think, raised the bar and is very focused on SIMON level one evidence, whether it's level 1A or level 1B, they've determined that the table that's in the guidelines would be tests that have level one evidence only.

Speaker 2

And I think it's probably fair to say as an industry, we will strive to get to that level of robust evidence demonstration. And so DECIPHER is there. And I think I'd be doing a disservice to our team and our KOLs and our PIs and collaborators by not calling out that distinction and how important that is. Having said that, when it comes to, for example, metastatic will be a good example of this. When it comes to launching a new part of the test that doesn't have NCCN guidelines, we need to continue to generate the evidence to get there.

Speaker 2

And so I do think the guidelines are very important, but as we demonstrated before we all had guidelines, you can continue to grow and penetrate the market without. They certainly help to, I think, step it up. But really at the end of the day, what they do is they demonstrate that the test has incredibly robust evidence behind it. With 85 publications, peer reviewed publications for DECIPHER, I couldn't be more pleased with how much evidence we've gotten. We are continuing we're not standing still, we're continuing to generate evidence at a very nice clip.

Speaker 2

So I think standing still, we're continuing to generate evidence at a very nice clip. So I think that certainly helps provide a tailwind, continued tailwind for Decipher. I don't want to get specifically into guidance. You can obviously see the testing guide that we have. We've guided to Afirma.

Speaker 2

And so the DECYPL volume is obviously a part of that equation as well.

Speaker 3

Yes. And the only other thing to help with that equation is effectively CYTO is the plug, if you will, between Afirma and DECYPLER and the CYTO doesn't necessarily grow that materially. So I think you can assume Cyto is roughly around the same level in 2025 as it was in 2024.

Speaker 6

And then just a clarification question in terms of Prosigna, is that I just want to clarify, but with the biopharma products and Prosigna, both of those will be obviously terminated with the French entity. Just can you clarify what products will continue forward? It appears that AFFIRMA and DECIPHER are the only two commercial products at this point, but I just want to make sure I have that right. Thank you.

Speaker 2

Yes, I'm glad you brought that up Puneet, because I really do want to avoid confusion on this and so want to be crystal clear. One is, there is no decision at this point to terminate or anything else. At this point, we're in consultation and we're considering no longer funding our French legal entity in that operation. That will impact if that goes to either a sale or bankruptcy process, it will impact our biopharma and other revenue, clearly. And that's coming out of that SaaS entity.

Speaker 2

We do have a small amount of biopharma revenue that comes out of U. S. Entity, but that's neither here nor there at this point in terms of getting into and I don't want to confuse the situation. Turning to Prosigna though, this is a really important point. No, we fully expect to continue BOSIGNA on the nCounter.

Speaker 2

And as we've mentioned before, at some point, we will move that test to NGS and we do need to get our IVDR approval for that test on nCounter and ultimately on NGS. So that's important. Now that is being run out of our being manufactured by our Marseille operation. And so being able to continue that supply of Prosigna is dependent, as I said in the prepared remarks on being able to find a buyer for all or part of that business. So we want to continue.

Speaker 2

We want to make sure our customers have access to that test. And that is top of mind for us right now. So no, this doesn't ultimately affect the long term goal and the long term IBD strategy. We're committed to our IBD strategy. We're committed to getting tests that make sense into other markets, including first off Europe.

Speaker 2

And so this doesn't change that commitment. What it might change, as I mentioned in the prepared remarks, is our timelines for when we're able to get that certification and launch those tests. And so we're going to have to revisit our development roadmaps depending on how this process plays out. And then we'll have an update on those timelines when we've done that. Hopefully, Puneet, that clarifies our situation.

Speaker 2

If there's any remaining questions, please do let me know.

Operator

Thank you. Our next question comes from Andrew Brackman with William Blair. Your line is open.

Speaker 1

Hi, everyone. This is Maggie Buie on for Andrew. Thanks for taking our questions. Maybe the first one on guidance. Could you talk about what you view our potential upside levers for Decipher in 2025?

Speaker 1

What type of areas can we see to pull upside there? Thanks.

Speaker 2

Yes. I mean, for me, I'd come from a couple of standpoints on Decipher. One is the significant amount of white space opportunity there in the market. As we've talked about the test is only 40% penetrated coming into this year. We clearly have a lot of share there, but there the key point there is there's 60% that isn't penetrated and our goal is to drive molecular diagnostics in prostate cancer testing to eighty percent.

Speaker 2

And clearly, we'd like to say that it'd be the leader there. So that is priority number one, two and three, and that's done through expanding the utilization with an existing account. It's done by expanding into new accounts. It's also done by expanding into new indications like as I said earlier, metastatic being a factor kind of later in the year than earlier in the year. The incidence is also growing sadly, which is an important point.

Speaker 2

And I think those are probably the key ones.

Speaker 3

The only other one I would add is typically at this point in time of the year, we don't have a ton of clarity on prior period collections. And so to the extent we see a strong amount of those over the course of 2025 that could be upside as well.

Speaker 1

Got it. Thank you. And then maybe just one on Nightingale. As you continue to make progress on enrollment here with over 85% of the enrollment completed, can you just talk about your view on the market opportunity here? Has there been any changes to that as you continue to make progress there?

Speaker 1

Thanks.

Speaker 2

Yes, the market thanks for asking. The market opportunity hasn't changed or at least our view of it hasn't. I mean, it's still leading major cause of cancers of deaths in cancer in terms of lung cancer, unfortunately. And it's a vast market, plenty of opportunity. The test utility, sorry, validity has already been demonstrated with respect to how it can actually help patients and determine and classify patients into appropriate categories.

Speaker 2

Nightingale will hopefully demonstrate and that's the key to it, but it also is able to change practice right. And patients will be treated differently depending on whether they have a low intermediate or high result based on our nasal swab test. But there is a tremendous amount of work to get done to get to that point, not only complete the enrollment, analyze the results, create a peer review publication from those results and get reimbursement in place. And we've always said, we will make sure reimbursement is in place before we launch the test and then we're off to the races. So no, nothing has really changed with respect to our view of the market and the market opportunities for nasal swabs.

Speaker 2

It all hinges on as it always has the clinical utility and us being able to demonstrate that through Nightingale. And it's too early to say whether that will be the case or not. Step number one is continuing enrollment and follow-up those patients and look at the data.

Speaker 1

Great. Thank you so much.

Speaker 2

Thank you.

Operator

Thank you. Our next question comes from Lou Li with UBS. Your line is open.

Speaker 7

Great. Thank you for taking my question. A lot has been asked, so I will keep it short. I guess my first one on the cyber, if I'm doing the math right, it seems like the guidance has seen 25% growth. Can I just get a little bit more color on that and how much is coming from pricing, assume the majority is coming from volume?

Speaker 7

And second, on the MRD, it seems like you're already you planning to submit a technical assessment to Modias in the quarter. I wonder what is the kind of like the latest timeline we can expect from our reimbursement outcome? And then do you think that all kind of like uses around government agency will impact the timeline for the review? Thank you.

Speaker 2

Yes, thanks. So on your first question, I think you're higher than the guidelines, the guidance would suggest for DECIPHER. Again, if you think about our guidance that we provided in the new Just for Envisia, it leads you to a testing revenue growth of 14% to 16% net of Envisia. And we said high single digits for pharma. So if you do that math, you get to site for somewhere in the low 20s, something like that.

Speaker 2

So slightly lower than you cited. And that's a volume, if you think about it right now, that's a volume factor more than everything else given and Rebecca feel free to jump in here if you got anything to add, but given we had a lot of one time collections last year, we had a big payer in the early part of last year that is now nicely embedded in the numbers. So think of it that way for Decipher. On MRD reimbursement, tech assessment I've said this quarter, and then as a case of completing everything we need to do in our lab, automation, etcetera, getting the test launched and then reimbursement should flow.

Speaker 3

And with regard to your question around federal agencies and will that have an impact, there's always a chance. I don't think any of us know really what the impact on the types of decisions that are going on will be. That being said, we are in active engagement with MolDX on this and other reimbursement questions and haven't seen any change in their posture or their engagement. So we would hope that this would progress as planned, but obviously there's always a tail risk to these sort of things given the dynamic of the situation.

Speaker 7

Thank you.

Operator

Thank you. Our next question comes from Sung Ji Nam with Scotiabank. Your line is open.

Speaker 5

Hey, this is Corey Rosenbaum on for Sung Ji. Thanks for taking my questions. So you're continuing to strengthen your clinical evidence for decipher bladder, including the recent study published in European Urology Open Science. Do you see the prognostic and predictive use cases of DECIPRE bladder as largely distinct from the MRD test under development? And if not, do you think there could be a significant opportunity to use both tests concurrently?

Speaker 2

Yes. So to the first part of your question, we do see it as distinct. Obviously, the MRD test has now become our most important priority in bladder for muscle invasive bladder cancer. And that has a very distinct use case for patients who've been treated. In terms of the prognostic test itself, clearly, it's another opportunity to drive more into the channel.

Speaker 2

It's more investment in the clinical utility, more studies like the ones that you mentioned and that will be part of our roadmap over time, I'm sure. But it's not the immediate priority right now. But of course, yes, the more we can continue to serve the urologists and their offices, the more we will do that as long as we see the cost of creating these studies is offset by the revenue opportunity in the future.

Speaker 5

Got it. Thanks for the insight. And again on MRD, given the sensitivity advantages you expect from the C2I test, do you believe that the test will be viable potentially in the non muscle invasive market as well for bladder cancer?

Speaker 2

There's actually, I mean, it's a platform, Ryan. You've talked about the sensitivity of it and the whole genome approach that we take for every sample, including just not just the initial sample, but the serial testing samples, we think is unique, helps improve the performance of the test in our mice performances measured by detection earlier than imaging. And so that we can we believe that that test will have multiple applications in multiple cancers. Muscle invasive bladder cancer is current focus, whether it can be utilized in other bladder cancers and or muscle invasive, Maybe, but that wouldn't be in my mind, that wouldn't necessarily be the first place we would go. I wouldn't say it as a larger market opportunity.

Speaker 2

I think there are larger opportunities where we currently have channel and serve customers or will have, where we could launch that platform. But we're not ready to actually give the detailed roadmap yet. But you can imagine anything is in play where there's a utility opportunity for MRD.

Speaker 5

Got it. Thanks for taking my questions.

Speaker 2

You're

Operator

welcome. Thank you. Our next question comes from Subbu Nabi with Guggenheim Securities. Your line is open.

Speaker 8

Hey guys, thank you for taking my questions. Coming into 2025, what is your commercial headcount, meaning what is the proportional mix of focus by product and where do you where would you expect to build out more over the course of the year? That's question one. And question two, regarding the long term outlook for DECIPHER, to the extent that is interest in using a digital pathology complement to your existing assets, how well are you positioned to bring something to market?

Speaker 2

Yes. So let me just quickly address the headcount question because one thing that's been really, I think important for both our decipher and Afirma franchise is we've had tremendous leverage in our sales team. So we haven't added significant number of sales head single digits over each year. And I don't see that changing going forward given the current opportunities we have to both test to broaden both market penetration and share. And I think it's roughly, as I said, 50 heads per firmer and decipher a little bit more.

Speaker 2

In terms of digital pathology, I think the important thing to think about there is some of the studies that we've seen so far really don't demonstrate that the digital pathology is any better than and in some cases actually not performing as well as the genomic test. And I think the reason for that is they kind of focus on different biology, different parts of the biology. So looking at different things and consequently, there's not a great deal of correlation there. So if anything, we see maybe a complementary opportunity in the future, but whatever we do see the opportunity to be, and you can imagine we watch it very, very closely, we couldn't be better positioned. And the reason I say that is we have hundreds of thousands of samples, tissue samples.

Speaker 2

We've already scanned in our lab over 50,000 samples across more than 30,000 patients and the vast majority of those have clinical outcomes. And so, with that richness of our data and remember the richness comes from us being able to run a whole transcriptome in every case that gives us rich genomic data, scanning is scanning. So we would have as rich digital topology data as anybody else would have. And then we have incredible AI capabilities already within our company. It's not like we have to go out and build or buy that.

Speaker 2

We already have that. And so with that richness of data, we could do whatever analysis we need to do and publish on that. Again, it would be a question of the priorities. We have lots of things to do right now, which we think have a better near term priority and opportunity for the company. But bear in mind, we always have this in our back pockets to the extent we need it.

Speaker 2

And we'll continue to do research and fund research or support research that looks at the opportunities for digital pathology and AI in our markets, not just in prostate. And we'll always stay ahead of the curve.

Speaker 8

Thank you for that. I'll hop back in the queue. Thank you. Thanks.

Operator

Thank you. Our next question comes from Tejas Savant with Morgan Stanley. Your line is open.

Speaker 9

Hello. This is Yuko on the call for Tejas. Thank you for taking our questions. Some of the current players in the MRD market are now pursuing both tumor informed and tumor naive approaches. What are your thoughts on that direction of travel and MRD?

Speaker 9

And could we see you pursue both options down the road? And then more importantly, do you think that physician preference will evolve where each approach is preferred in certain cancer types versus one size fits all approach?

Speaker 2

Yes, it's a great question. Of course, we think about that a lot. And I think in a nutshell, I do believe that our MRD approach with whole genome in particular lends itself very well to all the research and studies we would need to do to demonstrate validity in human naive. But I think at this point where we are in the market, our view is tumor informed where you have tissue obviously, is by far the better performing test. Human iE comes into its own where you don't have tissue, hard to get to tissue, etcetera.

Speaker 2

But right now for the vast majority of the market, you do have tissue, you have enough of it, you don't need a lot to do that initial sequence. And with a whole genome approach, it is by far the best approach. But as I said, it does lend itself to the studies we need to do to support human naive in the future. And I do think that both will be offered, whether a physician preference or not. I think it's a little early for me to say, I don't have the data to suggest one way or the other on that.

Speaker 2

Certainly, we could get that. But I think it's going to come down to a number of factors. I think what's most important is for a company like us that has the platform to be able to support whatever paradigms make the most sense for the patient and the physician in the future. And it's hard for me to imagine a world where, we're not all thinking about whole genome approaches five to ten years from now. I think whole genome is absolutely the way to go because it does support those kinds of studies and product enhancements and expansions.

Speaker 9

Great. That was helpful color. Thank you for that. And then my follow-up question, given the unique approach that you're taking in MRD with C2I, do you think that you have an opportunity to file for ADLT status? Is that something you may pursue?

Speaker 2

Obviously, for muscle invasive bladder cancer, the answer is no, we don't need to, right. So we are where we are right now and there is an LCD and we're going to be able to just get to the market as soon as we can with that approach. Yes, ADLT is for unique situations. And if there are unique situations where ADLT makes sense and it's as open to us as it is to anybody else. But, so I don't think I would I don't build a strategy around ADLT or not ADLT.

Speaker 2

Our strategy is built around, can we get a test reimbursed at an appropriate level given the number of sequences you have to do. And there are some things as an industry, I think we need to evolve in terms of how MRD gets priced. MRD is a paradigm that hasn't been contemplated when a lot of these coverage determinations were put in place. And so there's some evolution that needs to happen there. But with that said, I think we'll build our strategy around getting the test launched with the appropriate pricing, managing our COGS to a level where we feel that the test is able to perform with an appropriate level of gross margin.

Speaker 9

Great. Thank you.

Speaker 2

Thanks.

Operator

Thank you. Our next question comes from Mike Matson with Needham and Company. Your line is open.

Speaker 10

Hey, everyone. This is Joseph on for Mike. I guess on Decipher, a lot of levers of growth there, indication expansion, obviously, in the market in general, but maybe just to focus on share gains in the market from your competitors. Can you maybe just talk about a big picture what that looks like for you guys? Is it more individually with your sales force going in and converting people directly?

Speaker 10

Or do you think a lot of it is more passively driven from clinicians seeing stuff like the NCCN recommendation and just the division between your competitors in terms of clinical evidence? And then if I could just ask a follow-up. AfirmaGrid,

Speaker 2

I was just kind

Speaker 10

of curious if you could give any metrics there maybe compared to Decipher Grid, I guess, for the same proportion kind of opting for that. I believe you said it was somewhere around one to two one in every two positions for Decipher Grid. But yes, thanks for taking our questions.

Speaker 2

Yes, happy to. In fact, maybe I'll just go to the Grid one first. I don't remember the exact metric on it. I mean, you're right, it was one in two for decipher and the firm was roughly around the same, maybe 30% to 50% would be a reasonable estimate for that. The uptake has been pretty decent so far.

Speaker 2

In terms of decipher and share, you can't really separate sales team going out and blocking and tackling from what you described as the passive reaction or response from KOLs because there's kind of the sales team will highlight to the physician the extent of evidence that exists and what it means and why it's important including the NCCN guidelines. So if we take a step back, all of this comes from robust evidence. It starts with robust evidence, which in our view starts with our whole transcriptome approach that drives a lot of studies, both studies that we fund or support to studies that we aren't even remotely involved in that just get done with DECIPHER given how much real world data there exists for the test. And so yes, we see our a lot of studies being completed. Our sales reps bring those to the physicians' attention.

Speaker 2

Some obviously paid more attention to those studies than others. Same obviously those studies result in NCCN guidelines. They result in things like level one evidence, which then result in guidelines. And that again, that's an important factor to sway some physicians, not all, but some. I think when you put it all together, it's the blended effect of all of these things that has really driven decisive success in both RP biopsy.

Speaker 2

And I couldn't be more excited with the growth we've seen across all NCCN categories. And I think that just demonstrates how DECIPHER is really covering the whole care continuum. And once we add metastatic, I mean, I truly will be able to see the whole care continuum for DECYFIR or the whole risk stratification for DECYFIR patients. So now hard to say it's all of that. It just it's giving our sales reps incredible information to share with physicians and have a good reason to go out and do that.

Operator

Thank you. Our next question comes from Matt Sykes with Goldman Sachs. Your line is open.

Speaker 11

Hey, guys. This is Prashant Kota on for Matt. I have one question that's a two parter. So building off of Puneet's question earlier, is it possible to quantify the benefit of NCCN guideline inclusion for a given test in terms of adoption, insurance reimbursement and competitive positioning? And then my second part is, as you enter new indications, given your NCCN guideline inclusion for DECIPHER prostate, does this increase the likelihood that future tests you may develop will get included in guidelines?

Speaker 2

Yes, I appreciate the questions. It's not possible to quantify the benefit of NCCM because they're just part of a whole package of positive indicators that really support the use of the test for a patient. Obviously, it's helpful. It's incredibly valuable. But you can't literally take it apart and figure out which decisive test would have been utilized with or without NCCN guidelines.

Speaker 2

I don't think it actually helps us you're kind of at the starting point or a level playing field when it comes to new indications and different indications as well, different for different cancer types. So a good example of that is metastatic. I mean, the NCCN guidelines for metastatic is going to be based on the peer reviewed publications, what level of evidence when you get to Simon level one evidence, which is the new threshold. And we're going to have to get there over time. Same with a new indication in a new cancer type.

Speaker 2

So no, it's I don't think it helps you there at all. I do think that knowing what it takes to and having the engine in the company to support and create that level of evidence, have those strong robust studies with scientific rigor behind them, get them through peer reviewed publications. Those are all factors that help you get this kind of recognition that we're getting from NCC. And so there is a competitive advantage to having done it before, but that's how I would characterize it.

Operator

Thank you. This concludes our question and answer session and today's conference call. Thank you for participating. You may now disconnect.

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Veracyte Q4 2024
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