SOPHiA GENETICS S.A. (SOPH) Q4 2024 Earnings Report, Transcript and Summary

Good morning. My name is Liway, and I'll be your conference operator today. At this time, I would like to welcome everyone to the SOPHiA GENETICS Fourth Quarter and Full Year 2024 Earnings Conference Call. [Operator Instructions] This call is being recorded on Tuesday, March 4, 2025. I would now like to turn the conference over to Kellen Sanger, SOPHiA GENETICS Head of Strategy and Investor Relations. You may begin.

Thank you, and good morning, everyone. Welcome to the SOPHiA GENETICS Fourth Quarter and Full Year 2024 Earnings Conference Call. Joining me today to discuss our results are Dr. Jurgi Camblong, our Co-Founder and Chief Executive Officer; Ross Muken, our Company President; and George Cardoza, our Chief Financial Officer. I'd like to remind you that management will make statements during this call that are forward-looking statements within the meaning of federal securities laws. These statements involve risks and uncertainties that could cause results or events to materially differ from those anticipated, and you should not place undue reliance on forward-looking statements. Additional information regarding these risks, uncertainties, and factors that could cause results to differ appears in the press release issued by SOPHiA GENETICS today and in the documents and reports filed by SOPHiA GENETICS from time to time with the Securities and Exchange Commission. During this call, we will present both IFRS and non-IFRS financial measures. A reconciliation of IFRS to non-IFRS measures is included in today's earnings press release, which is available on our website. With that, I'll now turn the call over to Jurgi.

Thanks, Kellen, and good morning, everyone. I will start today's call by providing a brief recap of our performance in 2024, followed by what's ahead for 2025. I will then turn the call over to Ross, who will give a more detailed business update. George will close with a review of our financial performance for the year and the guidance for 2025. 2024 was a foundational year for SOPHiA. We laid the groundwork for accelerated growth in 2025 and 2026 by signing an impressive cohort of new customers, continuing to penetrate the U.S. market, and launching exciting new applications such as MSK-ACCESS and MSK-IMPACT powered with SOPHiA DDM. 2024 also presented challenges. BioPharma budgets tightened across the industry and our BioPharma business was impacted materially. In the face of these constraints, I was proud of the team for responding quickly and taking action. And I'm happy to see those actions already beginning to pay off. In 2024, we delivered $65.2 million of revenue, falling within our most recent guidance range. We exceeded expectations on the cost management side by delivering another year of high-impact improvements. Adjusted gross margin reached 72.8%, up 60 basis points due to targeted initiatives to expand our data compute capability. In addition, adjusted operating loss improved 20% year-over-year as we continue to improve efficiency across teams. Beyond these achievements, we also solidified our position as the most widely used AI platform in healthcare. In 2024, we analyzed a record 352,000 patients on SOPHiA DDM, that's almost 30,000 patients per month or 1,000 patients per day who receive insights from our platform. Our global reach expanded to nearly 800 healthcare institutions across more than 70 countries. This means that the patients analyzed by SOPHiA benefit from the collective intelligence of the world's top institutions as well as an artificial intelligence exposed to over 1.9 million patients since conception. During the year in which many companies talked about AI changing the future of healthcare, it was reassuring to see that at SOPHiA, the future is now. Thank you to the SOPHiA employees for making this vision a reality. As we look to 2025, we're excited to expand our leading position in the space by executing on 3 key growth drivers. First, we look to take advantage of the many new customers signed during 2024 by expediting implementation times and then expanding usage across those accounts. Second, we will continue capitalizing on the massive momentum we have in the U.S. And third, we will focus on growing our groundbreaking new applications, MSK-ACCESS and MSK-IMPACT, which are starting to have a notable impact on both the clinical and BioPharma businesses. I will now take a moment to discuss each of these growth drivers, starting with number one. I'm incredibly proud of the record 92 new core genomic customers we signed in 2024, including the 31 signed in Q4. In 2025, we will remain laser-focused on expanding implementation time for these new customers and expanding within those accounts over time. Last year, we created a new team focused especially on accelerating time to revenue. Those actions paid off as we implemented a record 35 new customers in Q4, up from an average of 19 customers over the past 3 quarters. I look forward to these customers beginning to generate revenue in 2025 and ramping up usage over the year. As the 92 new customers enter routine usage, another focus will be on expanding within this account by encouraging them to adopt additional applications over time. Expanding platform usage is an area in which we typically excel. For example, in 2024, 58% of our customers used 2 or more applications, 36% used 3 or more applications, and 21% used 4 or more applications. I'm proud to say that each of these metrics rose from 2023 to 2024. And next year, I look forward to seeing them rise again. The second growth driver for 2025 will be continuing our success in the U.S. Over the past few years, we have excelled at winning new customers and increasing market share. Clinical revenue grew 23% in the U.S. in 2024 and analysis volume grew 26%. We expect to continue this trend in 2025 as we bring more and more marquee accounts. In this area, 2025 is already off a great start. I'm excited to announce today that we recently signed Mount Sinai, one of the leading hospitals in the world located in New York City, who is adopting SOPHiA DDM for HemOnc and SolidTumors applications. Mount Sinai joins the Mayo Clinic and other top names in the U.S. who are using SOPHiA for their testing needs. Welcome Mount Sinai to the SOPHiA community. As I consider our progress in the U.S. over the last few years, I can't help feeling that we've reached an inflection point. Bigger and bigger institutions continue to join our network, volumes continue to grow materially, and the market will likely become our largest market globally at SOPHiA in 2025. New business pipeline in the U.S. is up more than 100%. We continue to build strong foundation for continued growth. Looking ahead, I'm excited to keep you updated on our progress in this market. The final growth driver I would like to highlight for 2025 is a new MSK-ACCESS and MSK-IMPACT applications. The launch of MSK-ACCESS on SOPHiA DDM has enabled hospitals and labs across the globe to launch world-renowned Liquid Biopsy testing from within the walls of their own institutions. In many cases, this decentralized testing results in lower costs and faster turnaround times while also enabling institutions to retain control of their patients' data for research or other purposes. Since launch, 34 customers across 20 countries have adopted the application. As we move into 2025, I'm excited for these 34 customers to continue entering routine usage over the coming months. Of the 34 customers signed to date, 15 have already completed implementation and will ramp up their usage over 2025. As these customers come online, they will provide a meaningful catalyst to growth towards the back half of the year. This is truly helping to democratize Liquid Biopsy testing across the globe. Beyond the impressive progress of MSK-ACCESS, I am also excited by the recent launch of the application SolidTumors testing counterpart, MSK-IMPACT. Since MSK-IMPACT's launch in October 2024, 7 customers have adopted the application. Our expanding network of decentralized SolidTumors and Liquid Biopsy testing is also continuing to initiate interest from BioPharma. BioPharma partners such as AstraZeneca have been excited to leverage the SOPHiA network to improve the deployment of their drugs and expand market access. In addition, the data from these diverse patient populations as well as the predictive multimodal algorithms we are developing on the data offer immense value to BioPharma for drug development and commercialization. I look forward to updating you on our progress with BioPharma partners and the expanding deployment of MSK-ACCESS and MSK-IMPACT throughout 2025. With that, I will now turn the call over to Ross, who will provide a more detailed update on each of these areas and make a few announcements on new business wins going into 2025.

Thanks, Jurgi. The go-to-market team shares your excitement for 2025 and are looking forward to executing on our plan of growth reacceleration. Before I give an update on new business, I'll start by highlighting some of the major trends from 2024. First, the clinical business, which is a majority of our revenue, performed admirably in 2024 with analysis volume growing 13% year-over-year ex-COVID. BioPharma headwinds, notably in HRD, impacted overall revenue performance, resulting in a reported revenue growth rate below our long-term expectations. We remain confident that the challenges faced in 2024 are now behind us and look for improved performance in 2025 and beyond. From a regional standpoint, North America and Asia Pacific outperformed in 2024 with 33% and 40% year-over-year growth in volume, respectively. EMEA performed well in the back half of the year as we emerged from some one-off challenges in Spain and France in the first half of 2024, which we discussed in detail during the second quarter call. The main outlier for 2024 was Latin America, which notably declined. The primary driver of this decline was the first quarter acquisition of one of our top customers by another lab. However, today, I'm proud to announce that we have rewon the business with the lab, which was acquired, and are in talks with the acquiring entity to service them across their full testing needs. This represents excellent proof of our ability to delight customers and create lifelong supporters of our products. Given this, we expect volumes in Latin America to resume to normal levels of growth in 2025. From an application standpoint, hematology was the top-performing application in 2024. SolidTumors and rare disease applications closely followed with growth rates above the company average. Hereditary Cancers, however, experienced a slight moderation in growth in 2024 as labs are increasingly shifting to our Exome applications. As we move ahead to 2025, we're excited to see high-growth new applications such as MSK-ACCESS and MSK-IMPACT come online and begin impacting overall growth in Solid Tumor and Liquid Biopsy. Beyond ACCESS and IMPACT, I'm excited to highlight a few other areas we are investing in which we will drive future growth. In 2025, we have a compelling product roadmap and an exciting schedule of product upgrades and launches. I'll take a moment to highlight 3 today. First, we are launching a new application called Enhanced Exomes, which offers customers a unique way to both analyze a patient's Exome while at the same time, retaining the ability to zoom into specific areas for deeper analysis of highly sophisticated variants of interest. This modularized approach to Exome sequencing has been very well received by customers and is already driving a large amount of late-stage pipeline opportunities. The second major focus from our product team in 2025 is a series of investments to further improve our Liquid Biopsy offering and solidify our place as a leader in the decentralized market. And last, we also plan to upgrade and further modularize our SolidTumors applications for CGP, solidifying our offering as a gold standard and taking advantage of joint selling opportunities with Liquid Biopsy by leveraging synergies between tissue and blood-based testing. Beyond application launches and upgrades, we're also thrilled to continue to roll out the new generation of SOPHiA DDM to all of our customers in 2025. The new generation includes a full technology modernization, moving the platform from Java to web and microservices. This upgrade not only creates a better user experience for customers, but it also enables us to scale our data compute more efficiently and launch new applications and features even more quickly than we do today. These launches as well as our strong menu of offerings across application areas are driving higher interest than ever from both our clinical and BioPharma customers. Clinical new business pipeline or potential incremental revenue beyond renewals and organic growth is at record levels, now cumulatively exceeding $90 million in value. A major driver of this growth has been mounting interest across the U.S. from a number of major healthcare systems, an area we look forward to updating you on in the coming weeks and months. From an application perspective, the growth in new business pipeline can primarily be attributed to hematology, rare diseases, which includes enhanced Exomes and the new applications, MSK-ACCESS and MSK-IMPACT. The MSK applications alone currently have over 60 unique opportunities in the pipeline. For these opportunities and others, I'm happy to share that we've been closing new business at impressive speeds. 2025 is already off to an exciting start with a strong list of new customers and signings to start the year. In EMEA, MSK-ACCESS has been a major catalyst, and I'm excited to highlight a few recent major wins. In Spain, we recently signed Fundación Jiménez Díaz, a leading oncology hospital located in Madrid to the Liquid Biopsy application. In Italy, we were thrilled to receive an endorsement from Professor Umberto Malapelle, the President-elect of the International Society of Liquid Biopsy and Chair of the Pathology Lab at the University of Federico Segundo of Naples, who is adopting MSK-ACCESS at his institution. In the U.K., I'm excited to announce today that we've now signed 5 of the 7 NHS genomic laboratory hubs, and they are now using SOPHiA. And last, in the UAE, we recently signed M42, one of the largest and most sophisticated healthcare systems in the Middle East with a presence across 28 countries to the Liquid Biopsy application. Congratulations to the EMEA team for this incredible start to the year. In North America, Jurgi highlighted Mount Sinai. I'm excited to announce today that we recently expanded our partnership with the Mayo Clinic. This leading hospital, which we originally signed in April 2024 is now adopting a second HemOnc application on SOPHiA DDM. We continue to look to this growth partnership. Beyond the U.S., we have made significant inroads in Canada and the recent signings of Sunnybrook Health Sciences Center in Toronto for SolidTumors and the Sir Mortimer B. Davis Jewish General Hospital in Montreal for MSK-ACCESS. In Latin America, we recently signed hospital Sírio-Libanês, one of the top hospitals in Brazil to the MSA application as well. On a final note, 2024 was an exceptional year in Asia Pacific, and 2025 is following suit as recent investments in the sales team in the region are paying off. I recently returned from a trip to visit customers in the region, and I'm proud to announce today that we're expanding our presence into the Japanese market. Genesis Healthcare, Japan's leading private genetic testing company with almost 3 million patients tested to date has entered a collaboration with SOPHiA to accelerate access to best-in-class genomic testing for the Japanese population. I'm thrilled by the opportunity from a clinical perspective, but also from a BioPharma perspective as the collaboration will explore ways in which we can port CROs and BioPharma together. Given the country's population size, sophistication in NGS and incidence rates, we expect that Japan will become a top 5 market for SOPHiA in the next several years. To conclude, 2025 is off to a strong start. Our focus will be on keeping new business momentum at the elevated levels that we experienced throughout 2024 while also expediting implementation times and looking for opportunities to expand across new accounts. The U.S. remains a key focus area with plenty of room for additional growth, and MSK-ACCESS and MSK-IMPACT continue to open doors across other geographies. So, with that, I will now turn the call over to George, who will provide a more detailed look at our fourth quarter financial results and update you on our outlook for 2025.

Thank you, Ross, and good morning, everyone. As Jurgi and Ross highlighted, 2024 was an exciting year from a new business perspective with several levers for growth going into 2025. Before I get to the outlook for this year, I'll start by providing a brief recap of Q4 results. Total revenue for the fourth quarter of '24 was $17.7 million compared to $17.0 million for the fourth quarter of 2023, representing year-over-year growth of 4% or 6% on a constant currency ex-COVID basis. FX headwinds from the strengthening U.S. dollar negatively impacted revenue in the quarter by approximately $200,000. Platform analysis volume was over 91,000 for the fourth quarter of 2024 compared to approximately 85,000 for the fourth quarter of 2023. Analysis volume in Q4 ex COVID related was approximately 9%. Gross profit for the fourth quarter of 2024 was $12.1 million compared to gross profit of $11.9 million in the fourth quarter of 2023, representing year-over-year growth of 2%. Gross margin was 68.2% for the fourth quarter of 2024 compared with 69.8% for the fourth quarter of 2023. Adjusted gross profit was $13.2 million, an increase of 5% compared to adjusted gross profit of $12.5 million in the fourth quarter of 2023. Adjusted gross margin was 74.2% for the fourth quarter of 2024 compared to 73.4% for the fourth quarter of 2023, increasing 80 bps year-over-year. As Jurgi mentioned, targeted platform improvements throughout the year continue to drive cloud compute and storage costs lower, an achievement we're all proud of and that will continue into 2025. Total operating expenses for the fourth quarter of 2024 were $29.6 million compared to $30.8 million for the fourth quarter of '23. R&D and G&A expenses declined year-over-year as our strong focus on cost optimization continues to yield results. We did have an increase in sales and marketing as we made some strategic headcount adds and increased our marketing spend. Cost control will continue to be a focus in 2025. Operating loss for the fourth quarter of 2024 was $17.4 million compared to $18.9 million in the fourth quarter of 2023. Adjusted operating loss for the fourth quarter of 2024 was $10.2 million compared to $13.3 million for the fourth quarter of 2023, improving by 23% year-over-year. EBITDA loss for the quarter was $15.2 million compared to $17.0 million in the prior year period. Adjusted EBITDA loss for the quarter was $9.1 million compared to $12.1 million in the prior year period. Lastly, total cash burn, which we define as the change in cash and cash equivalents for the fourth quarter of 2024, was $15.6 million compared to $9.5 million in the prior year quarter. This increase is largely due to the impact of exchange rate differences on our cash balances held in Swiss francs and Euros relative to our reporting currency, the U.S. dollar. Now turning to full year 2024 results. Total revenue for the full year was $65.2 million, representing year-over-year growth of 4%. Constant currency revenue growth, excluding COVID-19-related revenue was also 5%. As we mentioned previously, total revenue was materially impacted from a decline in BioPharma-related revenue in 2024. The year-over-year decline was approximately $4 million. Platform analysis volume was 352,000 for the full year 2024 compared to 317,000 in 2023, representing 11% growth year-over-year or 13% year-over-year growth, excluding COVID. Core genomic customers were 472 as of December 31, 2024, up from 450 in the prior year period and up sequentially by 10 customers relative to Q3 2024. While we added 35 new customers in the quarter, we churned out a few smaller accounts who had not generated revenue over the past 12 months. Nonetheless, annualized revenue churn remained low at approximately 4% for 2024, consistent with our 2023 levels. Our Net Promoter Score in the fourth quarter was 67, and our customers continue to be very loyal to the DDM platform. Our dollar retention for the year decreased to 104% in 2024 on both a nominal and constant currency ex-COVID basis. Gross profit for the year was $43.9 million compared to gross profit of $42.9 million in 2023, representing year-over-year growth of 2%. Gross margin was 67% for the full year 2024 compared with 69% for 2023. Adjusted gross profit was $47.5 million, an increase of 5.4% compared to adjusted gross profit of $45 million in the full year 2023. Adjusted gross margin was 72.8% for the full year 2024 compared to 72.2% for 2023, increasing 60 bps due to the ongoing compute optimizations. I am incredibly proud of this outcome and remains encouraged about our ability to expand gross margins going forward. Total operating expenses for the full year 2024 were $110.5 million compared to $117.7 million in 2023, improving 9% year-over-year. We continue to be very focused on our expenses and operating as efficiently as possible while still making strategic long-term investments in R&D and continuously improving our platform. Operating loss for the full year 2024 was $66.6 million compared to $74.8 million in 2023. Adjusted operating loss for the full year 2024 was $44.8 million compared to $55.9 million in 2023, improving 20% year-over-year. In this area, I would like to commend the team for maintaining a stringent focus on optimizing costs and improving operating loss, especially during a year of softer-than-expected revenue growth. EBITDA loss for the year was $58.0 million compared to $66.0 million in 2023. Adjusted EBITDA loss for the year was $40.2 million compared to $49.9 million in 2023. Lastly, total cash burn for the full year 2024 was $58 million, exclusive of the $15 million in cash received from the Perceptive credit agreement compared to $55.4 million in the prior year, up 5%. This increase was primarily driven by the negative impact of exchange rates on our cash balances held in Swiss francs and Euros relative to our reporting currency, the U.S. dollar. This significant appreciation of the U.S. dollar relative to the Franc and Euro in Q4 resulted in a negative impact of $3.6 million for full year 2024 relative to a benefit of $5 million for full year 2023. Cash and cash equivalents were approximately $80.2 million as of December 31, 2024. We also have the undrawn portion of the Perceptive loan agreement of another $35 million. Turning to our 2025 outlook. SOPHiA GENETICS expects to report full year revenue between $72 million and $76 million, representing 10% to 17% growth on a reported basis. Let me provide a few key underlying assumptions relative to our revenue forecast for 2025. First, as a reminder, new business signed typically takes between 6 and 9 months to complete implementation and begin generating revenue after which it typically takes another 3 to 6 months to ramp up to routine usage. This means that the new business from customers signed in 2024 as well as the momentum of our MSK-ACCESS and MSK-IMPACT applications will not begin showing up in revenue until the back half of 2025 at the earliest. As Jurgi mentioned, we will continue to focus on expediting implementation times in 2025 as they are critical to our revenue recognition. Second, given the performance of our BioPharma business last year, we did not factor any material growth from BioPharma into our guidance. The business remains in its nascent stages and revenue recognition continues to be complex. Nonetheless, BioPharma can be viewed as a potential accelerator for 2025 and certainly for 2026, depending on when new business is signed and the structure of those contracts. Third, we currently contemplate that exchange rates will remain volatile due to macro uncertainties. And as such, we are anticipating a moderate negative impact to reported results in 2025. With respect to seasonality, we expect 2025 growth to be mostly back half weighted as new business signed in 2024 comes online in the second half of the year and as MSK-ACCESS business begins ramping up to routine usage. As a reminder, Q1 tends to be seasonally softer from a revenue standpoint, whereby Q4 is seasonably stronger. The company expects adjusted EBITDA loss to be between $35 million and $39 million compared to $40.2 million in full year 2024. This guidance is based on the following expectations. We continue to make targeted investments in our platform, which should further optimize cloud compute and storage costs and therefore, expect gross margin to continue to expand slightly in 2025. For the near and medium term, we also expect to largely hold the line on operating expenses as we currently have the correct team size to support our medium-term growth objectives. This excludes some high ROI investments we will continue to make related to marketing activities as well as certain investments in the commercial team. Lastly, we will continue to revisit our discretionary expenditures and execute on identified savings in systems, professional services and certainly public company costs throughout 2025. The combined nature of these items and the natural operating leverage in the business from strong revenue growth will further our path to profitability over the next 2 years. Overall, the company remains committed to profitable growth and expects to be approaching adjusted EBITDA breakeven by the end of 2026 and crossing over into positive adjusted EBITDA in the second half of 2027. We are confident in our current capital position with respect to the achievement of these goals. As a reminder, we currently have access to an additional $35 million of capital through the financing line with Perceptive Advisors in addition to our cash and cash equivalents of approximately $80.2 million. With that, I would like to turn the call back over to Jurgi for the closing remarks before we take your questions. Jurgi?

Thank you, George. I'm incredibly excited about the year to come. As we approach 2025, our major focus is on growth. A record number of new customers gives us a strong base for expanding usage of our platform. The US market continues to provide huge opportunity and new applications such as MSK-ACCESS and IMPACT offer unique catalysts. In closing, I want to say thank you to our SOPHiA colleagues, partners, customers and investors for joining us in our journey to use AI to transform patient care. Together, we have built the most widely used AI platform in healthcare, impacting 352,000 patients in 2024 and over 1.9 million patients since inception. Please note, we are presenting at the Cowen Healthcare Conference tomorrow in Boston. I will also be presenting at NVIDIA's GTC Conference on March 17 in San Jose, California, unveiling how SOPHiA continues to pioneer using AI to change healthcare. We all look forward to continuing to update you on SOPHiA's future success. Operator, you may now open the line for questions.

Thank you. [Operator instruction] Our first question comes from the line of Subbu Nambi of Guggenheim. Your line is now open.

Yes. Good morning. Thank you for taking my questions. I know you're not assuming material growth for BioPharma. But what are you seeing in terms of BioPharma funding and any other recovery trends so far, fully realizing that that's not contemplated in the guide? And my second question is regarding the guidance, could you tell us about any metrics, indicators that give you, that gives you some line of sight into customer volumes, please?

Good morning, Subbu and thank you for your questions. So, I will start by reminding the obvious Subbu, that the BioPharma environment has not been easy over the last years with important budget constraints. And in our case, we came out of a strong 2023 performance on the BioPharma, which negatively impacted our overall revenue performance in 2024. And just reminding, as you heard about our full year numbers that besides that, the clinical market has been nicely growing in 2024. So, speaking about forward-looking BioPharma potential, as you may remember, we had splitted the teams with a team dedicated on Pharma Dx. So, for instance, sponsor testing, eventually CDx deals. and another team focused on BioPharma data. And thanks to that, we've been able to now refill our pipeline, Subbu, with more of a repeatable opportunities. Ross, now you've been leading most of it on the commercial side. I don't know if you want to give more color to Subbu.

So thanks, Subbu. So relative to the changes we made in the middle of 2024, I think we're starting to see the benefits of that in the pipeline and in some of the deals that we have later stage that we hope to be able to share later this year. I think I'll let George comment from a guidance perspective. But if we just look at objectively, are we seeing an improvement in both activity rate with pharma as well as in some of the dedicated areas where we've planted a flag and decided that's really where we're going to go after share and play. I think we've seen improved momentum. And frankly, we see enough opportunities out there to win to secure better growth for us. I think that being said, these deals do tend to take some time, right, to get to signature. So, some pharma deals, if they're larger, can be 6 to 12 months of negotiation and contracting. So just think about that in the context of when we began sort of the changes. And I would say as well, again, we're not quite at a place where like our clinical business, where we have a high degree of visibility typically on a near- to medium-term basis, so let's say, next 12 months, Pharma still, just given its size and the concentration of customers remains a bit variable. So that explains kind of our conservatism because we obviously didn't want to come into this year with the same posture we did with last year, which was having some deals at risk, right, and then not coming through. So, George, I don't know if you want to comment it just from a guidance perspective and then take the second part of the question.

Subbu, our guide does not include really any pharma growth. So obviously, we're at a low level given the 2024 pharma performance. We do believe that there's significant upside there in '25 and certainly in 2026. But our guide right now basically does not really factor in any pharma growth right now. So hopefully, we'll be able to outperform that. And I think for 2026, we're still committed to the pharma business. We're still as Ross said, we've still got quite a few proposals out there, and we do believe this is a significant long-term upside for us.

And then my second question was what indicators or metrics gives you some line of sight into customer volumes?

So, if you think about Subbu, how our model works, right? So obviously, we talked to you a lot during the year around the new business environment, right? And we shared, obviously, the new logos signed. We also had really good expansion that we sold throughout the year. And so again, given the lead time from signature to launch and revenue can be 6 to 9 months or even as much as 12 months for us for some of the newer products like Liquid Biopsy. We obviously have a backlog of signed contracts that will come online over the upcoming months and quarters. So, in that, that's what gives us confidence in the clinical business to our underlying volume assumptions. And obviously, to the degree that we continue to sign business at a more elevated level, you'll see that pull up the growth rate over the upcoming quarters back toward a level more consistent with our performance in the past. But I would say for the year, particularly relevant to the global market. So, if you look at some of the sequencing vendors and what they're sharing in terms of consumable growth, I think our ability to have grown volume 13% and data was up multiples of that, right? I think you can still see in a market that this year was maybe a little bit more constrained versus the prior year, we still gained share. And I think if you think about the new business environment that we're alluding to, obviously, that should give us a leg up as well over the next 12, 24 months and drive a lot of that growth reacceleration. I don't know, George, if you want to comment on that relative to the guide.

And certainly, as Ross said, we've built quite a bit of momentum in terms of signing new logos on. And actually, the MSK-ACCESS is also very important as well because that's at a very high price point and a significant revenue opportunity given the market for Liquid Biopsy testing and what we believe is the future of more decentralized Liquid Biopsy testing. So, as those new signings come online, we're certainly believing that the back half of this year, you're going to see a very significant growth and more in line with the historic CAGR of the business.

And our next question comes from the line of Mark Massaro of BTIG.

So in 2024, it looks like you grew volumes by 11% reported and 13% ex COVID. Is that the right way to think about application volumes in 2025? Maybe another way to ask is what's embedded in your ASP assumptions for 2025?

Good morning, and thank you, Mark. So first to start, Mark, as you heard about us, we've been signing a record of customers this year, right, 92 new logos. And some of those customers have already been implemented. And so, this is when we start to see volume of analysis in the platform. And so, what is important to follow with our model is a number of implementations. And so, taking a step back in Q4, we had implemented 35 new customers versus an average of 19 in the previous quarters and an average of 16 per quarter in the previous year, right? So, this should give you already a sense, Mark, of how by having more customers move now more quickly because of good bookings into routine implementation, volumes should grow up. On the ASP side, I will start by stating that, in 2024, as you may remember, we had some sponsor testing from BioPharma, in particular for HRD, and that the sponsor testing had terminated. And so, then the healthcare systems, for example, in Spain has to take the reimbursement on their side and which impacted our overall ASP. But Ross, I don't know if you want to give some color first on the ASP side and then on the volume side, how we're thinking about the future.

So as Jurgi said, obviously, if you think about volume, there are 2 components of that, right? There's sort of the new accounts coming online that will drive volume. And again, we've talked about that being strong, albeit it takes some time. And obviously, they also have to ramp up. They don't go to 100% utilization on day 1 of the sequencer. So those will phase in over the balance of the year. So, you can expect, as George mentioned, second half to be greater than first half. That being said, we also have seen strong growth on sort of the same-store side, both from the expand as well as in a number of the emerging regions, excluding any noise of the losses we had where we saw really good continued momentum. So certainly, we're feeling quite confident on the volume side, and that remains, I would say, predominance of the clinical growth. Although I would say if you look at what we're booking, right, and what will come into the mix, obviously, we're talking a lot about MSK-IMPACT and ACCESS. We've talked about now our enhanced Exome product. These all carry ASPs that are above our corporate average. And so, as that comes online and becomes a bigger part of our mix, that will pull the ASP back up. So, I think what Jurgi was kind of alluding to is some of what you see as ASP decline is really a function of some of the pharma-linked business that rolled off, particularly in HRD, and you saw this also from the market leader in that space. And so, I would say in that, again, expect this year to certainly be more volume than ASP biased, but we're hopeful that in the second half and into '26, you'll start to see those new products pull up ASPs overall as well.

I appreciated the disclosure that you guys have identified over 60 opportunities in 2025 for MSK-ACCESS and MSK-IMPACT. Can you give us a sense, I don't know if you have an internal target of what you think might be embedded in your guidance for converting that number. And then broadly speaking, do you expect MSK-ACCESS to be a bigger market than MSK-IMPACT, just given perhaps the market's preference for liquid at this time?

Yes. Thank you, Mark. I may start to give you a color of what we did last year first. So, before we move to next year, I will let -- well, this year, I will let Ross take that. And then I'm happy to give you a color of how we think of Liquid Biopsy combined with SolidTumors testing. So, as a reminder, right, Liquid Biopsy testing has been mainly done in a centralized way. And as it happens often when there is a clinical utility that is being demonstrated, you start having hospitals around the world, starting with comprehensive cancer centers who want to deploy these capabilities in-house to serve more quickly the patients that are next to them. And so, in that regard, we launched this MSK-ACCESS application last year, I think it was Q2 last year. And indeed, in a record time, we've been able to sign 34 customers for this single application within 10 countries, if I'm not mistaken, and all continents. And we then launched MSK-IMPACT, which is a counterpart of MSK-ACCESS, but starting from Solid Tumors testing, so for solid biopsy, sorry, in Q3 or Q4 this year. And since then, have already been signing 7 customers, right? And so, for us, this effort has been an important effort, both in terms of R&D investment, but as well in terms of commercial investment. And to your point, today, our sales pipeline is quite dominated by these 2 applications. And so, for 2025, Ross, you may want to give Mark a bit of perspective of how this should impact our performance.

Yes. So, Mark, I'm super pleased with where we are with both of these products given the time post-launch. I think it's probably the best uptake we've seen of a new product of this magnitude in the company's history. That being said, obviously, the time to revenue has taken longer. So, while we're seeing it on the bookings side, you haven't really seen a significant uptick yet in our revenue related to some of this adoption. So that's what's driving, again, a good amount of our growth in this year, particularly in the second half and then into '26. But I would say, overall, liquid, in particular, remains a super exciting category, as you know. I would say the challenge ex-U.S. is reimbursement is not consistent in many geographies. And so, a lot of different parts of the world are still, I would say, sorting out payment and then obviously, clinical evidence. And so, to the degree, and again, Jurgi gave you some flavor on the variety of geographic dispersion here. I think as we start to see evidence generation on the early users of MSK-ACCESS and as we sort of work with our pharma partners and others, on market access and adoption. I'm incredibly optimistic on what this product line over time can do both here in the U.S. And I would say as well, going back to George's comment on pharma and where we're hopeful, we also have quite a lot of activity there around MSK-ACCESS as a CDx and backbone and helping in both trial selection and enrollment as well as then the commercial asset. And so, I think Liquid, as you all know, has incredibly exciting potential everywhere, frankly, we look all over the world. But I think the pacing of adoption and revenue conversion will be dependent on the reimbursement and sort of market access landscape. And so not all countries look the same. But at the moment, we see a lot of activity in the pipeline. We're converting a high percentage of folks into signed customers. And I think after the first round of publications you'll get from us during this year, my guess is you'll continue to see that accelerate. And so again, it's an area we continue to focus on as a big upside growth driver for us.

And Mark, maybe just to conclude, so super exciting opportunity. Actually, the 2 are helping each other. And now in more and more customer sites, we're signing for both MSK-ACCESS and MSK-IMPACT.

And just last quick one. Can you peel the onion back a little bit on the new enhanced Exome product? Are you focusing in pediatric? Or are you focusing in adults in oncology or rare disease? I would just be curious to understand the focus area.

Yes. Thank you, Mark. So, at this stage is for anything which is germline, or inherited, not necessarily only [Rads] and others. If you take a step back, what happened is that with more knowledge that has been created on the biology and the clinical utility of genetic testing, labs have started to go to broader and broader panels, right? But by doing so and moving from targeted panels to Exomes, sometimes they accumulated a technical depth or a penalty on the accuracy of the identification of some specific type of variants in very important genetic considerations, regions basically that can be actionable. And so, this enhanced Exome concept now enable us, if you like, to support large labs and academic centers on having a single solution for all their inherited needs by covering many genes, but in the meantime, being able to zoom into specific type of regions where accuracy is extremely important. And so, while we started with that on germline at this stage, you may expect not this year, but in the future to see a similar trend on the somatic side.

And maybe just to quickly add, think about it from a lab economics perspective. In this case, right? So, a lot of labs today are really frustrated with both labor shortages as well as high labor costs as well as the complexity of running multiple workflows and the automation required to do so. So here, we're allowing a laboratory to basically get the benefit of the performance of a targeted panel, but in an Exome setting. So, let's say you're running carrier screening in PGx and hereditary and you want to do Exome, you can essentially do all of that in one product with one workflow. So, from a lab efficiency and automation standpoint, it's a very big step up. And the performance is world-class, not just on the Exome, but also on the more targeted panels where you tend to get a big degradation in quality as you move from targeted to whole Exome to whole genome.

And our next question comes from the line of Tejas Savant of Morgan Stanley.

So just a quick follow-up on the comments on ACCESS and IMPACT, helpful color there. How are you thinking about the pipeline, Ross, in terms of just the U.S. versus OUS split in light of some of your comments there. Obviously, there's the clinical versus pharma split. Let the question about sort of immediate revenue because both those products are still ramping. But as you look at your current pipeline and into 2026, what does that look like in steady state for you?

Yes. Thank you, Tejas. Indeed, as you pointed out, right, depending on the regions, eventually, the need and the adoption of ACCESS and IMPACT can be different. Let me start by reminding that the U.S. market has been the one where we've been growing the strongest this year. So, in the clinical volume of analysis, we've been growing over 20%, same on the revenue side. So, we've been able to indeed demonstrate that our model fulfills a need clearly in this market, which will ultimately be the main market for SOPHiA and a very important one, not only on the clinical side, but to be able to work with pharma. On MSK-ACCESS and MSK-IMPACT pipeline, we see opportunities everywhere. Maybe, Ross, you want to explain the dynamics in U.S. versus ex U.S.

Yes. So, I would say, certainly, there's quite balanced enthusiasm. Frankly, I'm a bit surprised positively in the U.S. with the scale of customers we're speaking to, both sort of existing laboratories that already have some sequencing capacity and then want to in-source or do their own Liquid, but also some labs at very large AMCs that are interested in setting up new NGS capabilities solely for this purpose as well as some other large panels. So, I think and again, it fits with what you're seeing in the sequencing world overall, where the variety of new boxes out there and the price points coming down and the, I would say, streamlining of the workflows, allowing for more institutions to be able to do this themselves. So, I would say it's quite balanced globally, much more than our revenue would project. And again, I'm quite optimistic both U.S. and ex U.S. on that trajectory. I think, again, today, you think about a market like Japan, which we highlighted as a real new entrant for us. I think this will be a big market for ACCESS and IMPACT, frankly. And I think it will be because we can, again, work with local players to bring down the cost of these solutions materially and provide a world-class ability in a market that pricing and reimbursement is still not as, I would say, significant as in the U.S. In terms of clinical and BioPharma, again, I would say we certainly are quite confident given the customer data and the pipeline data we shared around the clinical adoption and many of our central labs and AMCs that we serve. But on the pharma side, it's also quite significant. Again, this is a product that really solves a huge need for trial enrollment that I would say, addresses a major challenge, particularly in Europe, in Latin America and parts of Asia Pacific with respect to access to Liquid Biopsy testing more locally. And so, in that vein, again, for pharma, as they're thinking about CTA, CDx, there's quite a lot of interest. And so again, I don't want to obviously overpromise, and we obviously didn't include much of that enthusiasm in our guide. But certainly, on a multiyear basis, I'm quite optimistic around that contributing to our P&L from a pharma standpoint as well.

Got it. That's helpful. And then one question for you, Jurgi, on the policy side of things. Lots of chatter here around the fallout from NIH indirect cost caps, causing disruption in academic labs if they were to come through here. Are you seeing any sort of shift in behavior among your U.S. academic medical customer base at all? Could this actually be a benefit in some sense to you guys if some of these customers look to prioritize revenue-generating activities to offset budget shortfalls?

Yes. Thank you, Tejas. And obviously, these are things that we've been closely following. Now on our side, the exposure to the NIH cuts are minimal. Actually, we have one customer, which might be impacted about it in the U.S. But beyond that, we don't think we have any other customer. And even on this one, given that we're not selling lab equipment, right, we are selling the platform on a consumption basis, we hope that this will be resolved quite soon.

Got it. Okay. And then, George, one for you on just the guide. Any incremental color you can share in just phasing and FX impact that's embedded in the guide? And as you think about that path to EBITDA breakeven by year-end '26, any sort of like early framework on top-line assumptions to get you there to breakeven by '26 and sustainable positive EBITDA in the back half of '27?

Yes. I mean if you look at where we're expecting to be, I mean, in terms of our profitability, and we're very focused on our cost reductions and growth we believe that we can actually grow our gross margin slightly. So, we're looking for a modest improvement in our gross margins. And if you want to add in a little bit for sales commissions and the like, but our anticipation is we'll drop about $0.60 of each incremental sales dollar down to the bottom line. So obviously, if you factor this year's growth in, you factor hopefully growth that's more in line with our historical CAGR in '26, we've said we'll be approaching profitability by the end of '26. So, EBITDA, adjusted EBITDA breakeven and then adjusted EBITDA will go positive into 2027. So that's clearly been our guide, and it's our expectation. And again, we, you've seen the focus on operating expenses that were down this year. You've seen the improvement in COGS. So, while we're very focused on growth, we haven't lost the need for cost control. And the good part of the DDM platform is it is very scalable. So, we're at a point now where we believe we've got the right-sized sales force. We've got the rightsized infrastructure and really now the incremental growth should have a very nice drop down to our adjusted EBITDA. And then FX, I mean, we said a modest negative into the model that we factored in. I'm not smart enough to project what's going to happen in the market with tariffs and currencies and who knows what. But I think right now, we saw a strong appreciation of the U.S. dollar. We actually do hold most of our cash in U.S. dollars, but our operating expenses, we have a significant payroll here in Switzerland, and that is paid, those workers clearly are paid in Swiss Francs. So, and our customers in Europe typically do pay us in Euros. So, we have a good match in terms of our cash flows. But there's obviously -- we modeled in a very small negative in terms of 2025 guidance. I don't think we have a crystal ball as to what's going to happen in the currency markets, though. So, it's, hopefully, we'll see some stability. And historically, the Swiss Franc has been a very strong currency and Europe is certainly a robust market. So, I think we're just hopeful that we sort of get into some stability and 2025, we can really focus more on the core business and less on the external market dynamics.

And our next question comes from the line of Bill Bonello of Craig-Hallum.

So obviously, a lot of exciting stuff going on with the new customer wins and the pipeline. But volume growth was quite a bit lower than it's been in recent quarters and volume was flat sequentially. And so, I'm just trying to get a little more color on what happened in terms of volumes in Q1, in particular, why we shouldn't be concerned about that. And then I do have a follow-up.

Yes. Thank you for the question. So indeed, right, the year-on-year volume growth in the clinical market was 13% in terms of number analysis, while it was 9%, excluding COVID for Q4. Ross, do you want to give some color on what has been trending that versus prior year?

Sure. So, Bill, a couple of things. So, one, just to maybe set the table. So, we were actually in line to slightly ahead of our internal forecast, right? So, this is sort of how we saw the second half playing out based on our own internal metrics. So, this was not a surprise for us. I would say, if you look at the prior year, we did have last year a very strong 4Q versus 3Q. This year, I would say our step-up in 3Q versus 2Q was much bigger than anticipated. And so, we expected some consumption to, I would say, renormalize in the fourth quarter, which is what it did. And so, I would take the half more so versus the half versus just a quarter in and of itself because sometimes you'll see things even just by a few weeks in a consumption or usage-based model shift around. I would also say we've obviously called out Latin America as being a weak point for us. We saw pretty weak volume growth year-on-year. This was, again, a typically seasonally strong quarter in LatAm. And so, with the one customer that we did churn, there was a pretty big drag in this period, again, low ASP customer, but one that was quite large of volume that essentially, we had lost because they got acquired by another large lab in the region. Now as we pointed out, we did regain a portion of that customer in the fourth quarter, which will start benefiting us in the second half of next year. We've also seen growth in LatAm kind of get back to more normalized levels in the first quarter. And so net-net, for us, again, we're on trend. We expect a reacceleration, and I'm not particularly concerned. And again, I would say the other big piece just to keep in mind on volume is that 35 customers that did enter routine. That's a record for us in the fourth quarter. So, it should give you confidence in that reacceleration into both the first half and second half of next year.

Okay. That's really helpful. And then just the final thing, just to kind of push a little bit harder on where Mark was going on the guidance and how it kind of breaks out between volume and ASP. And you gave some really general color and maybe that's the most you're willing to do. But I guess I'm not sure if I should be thinking about 90% of that growth coming from volume or just so we're aligned with you in terms of expectations.

Yes, George?

Yes. Thanks, Bill. Yes. No, our 2025 guidance really assumes a fairly flat ASP. So really, if you're modeling, the revenue growth is really going to be volume-driven. That's our expectation. Certainly, we're hopeful that if, obviously, the MSK can really crank in, that can pick it up. But we are entering in some markets where the ASP would be lower potentially. So, all in all, we've modeled a fairly flat ASP. And really, the revenue growth that we're projecting is coming on the volume side.

And our last question comes from the line of Dan Brennan of TD Cowen

This is Kyle on for Dan. I wanted to build off an earlier question about the guide this year and that in the context of your long-term guide. Is the long-term range of 30% to 35% constant currency growth still realistic? And I guess you guys sound like you have a very, very strong pipeline. I guess what will it take to get you back towards this range?

Yes. Thank you, Kyle. So, I will let George give you more financial color. But as you have heard from us, right, the bookings have been strong in 2024. We know that the pipeline is significantly superior in 2025. and we significantly as well improve implementations. Hence, we highlighted the 35 new customers we implemented in Q4 2024 versus an average of 19 in the previous quarters and an average of 16 for each quarter of 2023. So given that with our model between implementation and seeing revenue ramp-up, it takes about 6 months. This gives you a sense of how you should see some of the accelerations. Plus, now if you are converting the pipeline in terms of net new booking with the same rate, one should expect that we sign more deals and hence, we implement more customers, and we accelerate the volume ramp-up. So, George, I don't know if you want to add anything else.

Yes. No, it is important to realize, as Ross pointed out, that there is a long-time horizon between when we sign the contract. We actually have a program called MaxCare, where literally clients, we walk them through the process, hold their hands through this, make sure that they're doing everything, they're passing all of the quality milestones and their validation. And that's a timely process to make sure that things are up to speed. So, there is that time horizon between when they actually sign the contract to when they're really ready to go into production. And then after they graduate from the MaxCare program, as Ross said, even then, typically, you might see 2 to 3 months before they're really fully into routine production. So, we have sort of modeled that in. But again, as our pipeline comes in, the growth pipeline we're signing today, that's going to be revenue out in Q4 and in 2026.

And I would say, in general, right, in the end, part of why we shared so much color, Kyle, around the new business pipeline is obviously because of that delay. And so, what we were trying to do is give you confidence that, obviously, we weren't pleased to some degree with the growth rates, right, we put up in 2024. We're more confident, obviously, in the reacceleration to 25. And obviously, our ambition is to get back to more normalized growth rates for us by '26.

Got it. And maybe just another one on what you're seeing regarding broader clinical volumes for NGS. Is the market growth rate here a key building block for your own growth rate?

Well, obviously, the fact that in the market, volumes might go up overall is good for us, right? And hence, in that regard, we very welcome seeing demand as well for new types of sequencers. So obviously, Illumina is the dominant player, a very good one. And most of the data computing we do is on Illumina. But I think the fact that others are as well pushing to enter that market should give you a sense that they believe that the market will grow, right? Otherwise, they wouldn't have made the investments. And so, we believe that still there is so much more to do in NGS testing. When you look at the number of patients suffering from cancer and who are being tested, we are far from helping all the patients today, same for rare inherited disorders. So, in this phase of decentralization, democratization of genomic testing, and precision medicine, we expect volumes to continue to grow, and this will require industrial-scale platforms. And that's why I think we're very, very well positioned as volumes go up, not only to benefit from our own organic efforts but as well to benefit from overall market growth.

Yes. I would say, look, the market is not what we're counting on ultimately to drive the growth. Right now, we are taking share, right? If you look at our win rates despite a significant increase in the pipeline, we are winning, right, at a very high clip. And in some cases, in some products, well above, I would say, industry standards. So again, I think in general, in terms of why we are increasingly confident around getting back again to that more normalized growth rate is we've put the right steps in place to be able to sort of execute and scale up our commercial efforts. We have a great product portfolio right now. It's feeding what the market needs. And so, we're seeing that come to us. And so, we're really relying on share to drive the majority of the growth. And if we get more, I would say, volume, as Jurgi stated, from the end market and again, with some of these new sequencing platforms coming in, unlocking some volumes, that will be an upside for us.

And there are no further questions at this time. I would now like to turn the call to Jurgi Camblong, Co-Founder and CEO, for closing remarks.

Yes. Thank you, everyone, for joining us today. Thank you as well to the SOPHiA colleagues for their commitment in our journey and our mission, to our clients for trusting our technology and our services. And just I would like to remind you that tomorrow, we are at the Cowen Healthcare Conference in Boston. And so, we would be happy to meet you there if any interest on SOPHiA stocks. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Have a good day.