Biodesix Q4 2024 Earnings Call Transcript

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Provided by Quartr
March 3, 2025
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Operator

Good day and thank you for standing by. Welcome to the BioDesk's Q4 twenty twenty four Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.

Operator

I would now like to turn the conference over to Chris Briesley, BioDesk Investor Relations. Please go ahead.

Chris Brinzey
Chris Brinzey
IR at Biodesix

Thank you, operator, and good afternoon, everyone. Today, BioDeskix released results from the fourth quarter and full year of 2024. Leading the call today will be Scott Hutton, Chief Executive Officer. He is joined by Robin Harper Kaui, Chief Financial Officer. An audio recording of today's call and the press release announcement with the quarterly results can be found in the Investor Relations section of the company's website at biodesix.com.

Chris Brinzey
Chris Brinzey
IR at Biodesix

As today's call includes forward looking statements, we encourage you to review the statements contained in today's press release and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance and results to differ materially from those contained in the forward looking statements made on today's webcast. In addition, we will discuss non GAAP financial measures on this call. Descriptions of these non GAAP financial measures and reconciliations of GAAP to non GAAP financial measures are included in today's press release. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thanks, Chris. Twenty twenty four was an excellent year for the BioDosix team as we delivered on our annual objectives across the board. We delivered $71,300,000 in total revenue, exceeding the midpoint of our improved revenue guidance and delivered 45% year over year growth. We increased our already strong gross margins to 78 percent for the year and improved our adjusted EBITDA loss by 32% on our path to profitability. At BioDessics, our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible and address immediate clinical needs.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We leverage a multimodal approach that includes genomics, proteomics and radiomics combined with AI to discover developing commercialized innovative diagnostic tests for physicians, biopharmaceutical, life sciences and diagnostic companies to help improve patient care. Clinically, we focus on lung disease because there's a massive unmet medical need. Pulmonologists diagnose, treat and manage over 50 different lung diseases, including lung cancer. In The U. S, One In Sixteen people will be diagnosed with lung cancer in their lifetime and it is responsible for one in five deaths from cancer annually.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Our commercial team currently sells five Medicare covered tests addressing lung nodule management and treatment guidance following the diagnosis of lung cancer, supporting clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. In 2024, we continued to invest in the expansion and professional development of our lung focused sales and commercial teams, extending our reach in clinics specializing in the management of lung nodules, the diagnosis of lung disease and their referral networks. We grew 2024 lung diagnostic testing revenues by 43% over 2023, driven by 40% test volume growth and the expansion of reimbursement coverage of our nodule tests throughout the year. As the leader in lung nodule management testing, our initial sales approach focused on interventional pulmonologists, who are specialists in diagnosing lung cancer. After gaining clinical experience with the test and observing the utility for their patients, leading interventionalists worked with the Bioethics team to educate and enable their referring pulmonologists to order the notified test.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

As a result, the proportion of high risk patients seen by interventionalists increases. Conversely, the general pulmonologist keeps the patients at low risk in their practice and monitors them with CT surveillance. In 2024, we began seeing some interventionalist and general pulmonologists identify opportunities to educate and enable high volume primary care providers to implement the same testing and referral practices. Claims data shows that approximately forty nine percent of all patients with lung nodules have their first imaging workup conducted by primary care providers, the majority of which are managed by approximately 10,000 to 15,000 primary care physicians. We conducted a pilot program in the second half of twenty twenty four to assess how best to leverage the referral networks and access more of the existing addressable market.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

The pilot tested the viability of having a sales teammate support the lead sales professional in territory and follow the referral pattern from primary care into pulmonology. That pilot was a success, demonstrating that adding additional sales professionals supporting a senior pulmonology sales representative facilitates us accessing more of the addressable market across pulmonology and primary care in a given territory. So what does that mean? We will continue to grow and expand the sales force in 2025 by adding approximately six sales teammates per quarter, ending the year at approximately 95 teammates supporting 50 territories, up from 71 teammates supporting 48 territories in the fourth quarter of twenty twenty four, with the majority of these new additions going to support this approach. To support the ongoing adoption of our tests by healthcare providers and payers, we published and presented new clinical data and health economics and outcomes research data at various key physician society meetings throughout 2024.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We also announced the launch of our new clinical study CLARIFY in the fourth quarter. In this study, we are collecting patient outcomes and other clinical information on 4,000 patients who've received notified testing in clinical practice with at least one year of available follow-up. The CLARIFY study uses a cost effective study design that is faster to execute compared to a standard prospective design. In the three months that the study was open in 2024, we accrued over 300 patients with that increasing to over 600 to date. While the primary goal of the CLARIFY study is to confirm performance of the NOTIFY CDT and NOTIFY XL2 test in a broad population of patients, the study will also allow us to answer several specific questions that are of particular importance to healthcare professionals, such as the relative performance and utility of NOTIFY testing compared to PET scans.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We know PET scans are used extensively in the initial assessment of nodules despite having a very high false positivity rate, which limits their utility. We have observed in several physician practices that the incorporation of notified testing in a system wide structured nodule management program can have a positive impact on the early diagnosis of lung cancer, leading to more cancers being caught in the early stages of the disease. This is something we will also look to document within CLARIFY study sites and are excited to see this effect demonstrated in a broader population. We expect to start releasing data from the CLARIFY study in 2025 and a number of presentations and publications to be generated over the course of the next two years. Enrollment and patient follow-up in our prospective randomized clinical study, ALTITUDE, is progressing well under the supervision of the Data Safety Management Board.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

The DSMB is scheduled to meet again in the second quarter and will provide timing expectations for the study mid year. If the DSMB recommends closing the study due to the endpoints being met at that time, we could be in a position to start releasing data before the end of the year. Now let's shift to our diagnostic development services. We've talked over the past year about the increasing demand for our services, resulting in 70% growth in diagnostic development services revenue year over year. With dollars under contract, but not yet recognized as revenue improving to $12,200,000 at the end of twenty twenty four, up 54% versus the end of twenty twenty three.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

This is a differentiated service offering that leverages our multimodal approach and R and D expertise to help deliver insights that our partners use to personalize patient care and help improve disease detection and treatment evaluation across various disease types. New data from one such partnership demonstrating the performance of the VerisRET test in advanced prostate cancer was presented at the AACR liquid biopsy meeting in San Diego in the fourth quarter. The early findings showed that the immune classifier Verastat may accurately stratify metastatic prostate patients initiating standard of care hormonal therapy into good and poor prognosis groups. A second study showed that Verastat may also be valuable in predicting response to KEYTRUDA in a wide spectrum of metastatic solid tumors. Further validation studies are ongoing.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We will see new data and continuing research and development efforts on our existing tests and new tests throughout 2025, including a new presentation at the Precision Medicine Tricon on March 11 entitled Accelerating Drug Development in Prostate Cancer Using MRD as an Endpoint. We look forward to sharing more in our upcoming calls. Moving on to establishing expectations for company performance. In 2025, we expect to one, deliver $92,000,000 to $95,000,000 in total revenue driven by growth in our lung diagnostic testing and our diagnostic development services two, maintain our already strong gross margins in the mid to upper 70s and three, achieve adjusted EBITDA profitability in the second half of the year based upon our cost disciplined approach and revenue growth. With that, let me turn it over to Robin to review the financial performance.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Robin?

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

Thanks, Scott, and good afternoon, everyone. Revenues for both the fourth quarter and the full year were in line with the numbers pre announced in January. Fourth quarter total revenue was $20,400,000 a 39% increase over the prior year. Full year revenue for 2024 was $71,300,000 a 45% increase over 2023. Lung diagnostic testing revenue in the fourth quarter of twenty twenty four was $17,200,000 from approximately 14,600 tests as compared to $12,800,000 from approximately 10,900 tests for the fourth quarter of twenty twenty three, representing 34% growth in revenue and test volume.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

Lung diagnostic testing revenues for the full year was $64,700,000 from 54,300 tests, representing 43% growth in revenue and 40% growth in tests. Diagnostic development services revenue, which we previously referred to as biopharma services, was $3,200,000 in the quarter and $6,600,000 for the year, representing 7270% growth over prior periods. We entered 2025 with $12,200,000 under contract but not yet recognized as revenue, which is a 54% increase over the prior year. Gross margin percentage in the fourth quarter twenty twenty four was 78.7, up from 77% in the fourth quarter of twenty twenty three and seventy seven point zero percent in the third quarter of twenty twenty four. The full year gross margin was 78.2%, up five percentage points over the full year 2023.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

Overall operating expense, excluding direct costs and expenses, was $22,700,000 in the fourth quarter, which was a 25% increase over the fourth quarter of twenty twenty three and flat to the operating expense in the third quarter of twenty twenty four. Full year operating expense was $90,200,000 which was an increase of 17% over 2023. Operating expenses include $2,700,000 in non cash stock compensation expense and depreciation and amortization in the fourth quarter and $12,400,000 for the year, an increase of 3243% as compared to the prior year period. The increase in operating expenses versus the prior year quarter is primarily the result of an increase in sales and marketing costs to support lung diagnostic testing sales growth to enhance product awareness and drive adoption as well as an increase in non cash depreciation expense related to the leasehold improvements in our Louisville, Colorado office and laboratory, which opened in January of twenty twenty four. Net loss for the fourth quarter twenty twenty four was $8,300,000 an improvement of 10% as compared to the fourth quarter of twenty twenty three and twenty percent improvement sequentially.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

For the year, net loss was $42,900,000 which was an 18% improvement over 2023. Adjusted EBITDA, which excludes non cash and other one time items, was a loss of $3,900,000 which was a 19% improvement over the fourth quarter of twenty twenty three and a 30% improvement sequentially. For the full year, adjusted EBITDA was a loss of $22,100,000 a a 32% improvement over 2023. We ended the quarter with $26,200,000 in unrestricted cash and cash equivalents as compared to $31,400,000 at the end of the third quarter. Subsequent to the end of the quarter, we amended our term loan agreement with Perceptive Advisors to extend the availability of the $10,000,000 tranche fee loan.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

Based on our expected growth and the leverage we have seen in the business over the past year, we believe we can fund the business to profitability with the available cash on hand. Now, I'll turn it back to Scott for some closing thoughts before the Q and A.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thank you, Robin. It is an exciting time at Biodesec. We believe that we have both the opportunity and the responsibility to transform the standard of care in diagnosis and management of patients with lung disease. We have the best pulmonology focused commercial team in diagnostics with first mover status and lung nodule management and an ever increasing body of robust clinical and health economic data. We have the momentum to drive greater clinical and payer adoption for this large underserved population.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We expect 2025 to be a transformative year for BioDessics in which we will increase revenue from the adoption of our lung diagnostic test and diagnostic development services and present new data on our existing test and pipeline test to further support adoption. We look forward to sharing more with you in the coming quarters. Let's now move to questions.

Operator

Thank you. And our first question today will be coming from the line of Andrew Brackman of William Blair. Your line is open.

Andrew Brackmann
Equity Research Analyst at William Blair & Company, L.L.C

Hi guys. Good afternoon. Thanks for taking the questions. Two for me on the financial side of things. One, as it relates to the revenue guidance, can you maybe just sort of peel back those targets a little bit?

Andrew Brackmann
Equity Research Analyst at William Blair & Company, L.L.C

How should we be thinking about that between the testing business and the biopharma business? Just any color that you can share with respect to the assumptions between volume and ASP growth for 2025? And then separately here, just on the profitability outlook, appreciate you guys reiterating the adjusted EBITDA target for the back half of this year. Can you maybe just sort of talk to us though about the drivers of that? How do we bridge from today to that goal on the adjusted EBITDA front?

Andrew Brackmann
Equity Research Analyst at William Blair & Company, L.L.C

Thanks.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

Thanks, Andrew. Yes, we expect the biopharma services component of revenue for 2025 to be pretty consistent with the portion that it has contributed in prior years. I expect it to be sort of about 8% to 9% of the total guide in that biopharma services bucket and the remainder coming from lung diagnostic services. In our models, we tend to be pretty conservative on the ASP front. And while we do model in a slight uptick in ASP over the course of the year from the improvements we expect to see from our increasing number of coverage policies, The vast majority of that revenue growth is all from volume and not from any either one time items or any big changes in ASP.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

On the EBITDA front, it's the combination of the growth in revenue and then a tight control on our expenses. While we are expecting to add sales teammates across the year, consistent with what we've said in the past earnings calls, we are keeping a very tight clamp on all other expenses to ensure that we get to adjusted EBITDA breakeven in the second half.

Andrew Brackmann
Equity Research Analyst at William Blair & Company, L.L.C

Perfect. And then Scott, maybe one for you. You gave a lot of nice color on sort of the expansion of the sales team and also the pilot that you ran in the back half of twenty twenty four. Can you maybe just talk a little bit more specific about what you saw in that pilot? What you learned from and sort of the key takeaways and what drives the confidence of the expansion of that model?

Andrew Brackmann
Equity Research Analyst at William Blair & Company, L.L.C

Thanks guys.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes. Thanks Andrew. It's a great question. You know, what we were aware of is what the claims data told us and we knew that one of the challenges pulmonologists have is getting those patients that have a lung nodule that's already been identified, getting them out of primary care. And the estimates are that approximately forty nine percent of them are managed at primary care or stuck.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

So through that pilot program, not only were we able to demonstrate that they were accessible, you know, we followed the lead of ordering pulmonologists, that helped guide, educate and train how they would like the test results received. There's a couple other things that make that call point a little more, viable than most may think. One is that primary care physicians are very comfortable with phlebotomy services and offer them on-site. So what we noticed was, that we were more effective and efficient in those call points because we weren't having to offer mobile phlebotomy services or our self collection device provided by TASO. So we found that that makes us a little more effective and efficient, right up front.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

You also worry when you have a patient that leaves the office, that there's a retention gap. And so what I mean by that is as patients head away, what's the likelihood that they're compliant to that follow-up, blood draw and then subsequent visit? So much of that we were able to demonstrate early on that those patients were viable, they were accessible, and what we saw with the primary care physicians was they were pleased and saw the utility in the test. It really helped guide them where to refer those patients on, and maybe even more importantly, which pulmonologist to refer them to. Is that helpful, Andrew?

Andrew Brackmann
Equity Research Analyst at William Blair & Company, L.L.C

Very helpful. I'll stop there and let others ask. Thanks, Scott. Thanks, Robin.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thank you, Andrew.

Operator

Thank you. One moment for the next question. And our next question will be coming from the line of Kyle Mikeson of Canaccord. Your line is open.

Kyle Mikson
Managing Director & Senior Research Analyst at Canaccord Genuity - Global Capital Markets

Hey guys, thanks for the questions. Congrats on the quarter and the year. So you're getting closer to you have breakeven. Could you just provide an update on the pipeline? It seems like that's still also some skill based on the 10 ks, but just is that given you're kind of getting to a point where you could be sustainable from a capital perspective, you could probably invest more in there.

Kyle Mikson
Managing Director & Senior Research Analyst at Canaccord Genuity - Global Capital Markets

So could you just provide an update on that? I want to just ask a follow-up on that note as well after your answer. Thanks.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes. Thanks, Kyle. Great question. We stated in the past that our product pipeline is robust, but we would be mindful of where we were in utilization of cash. And we also want to be mindful of the ever changing kind of reimbursement landscape.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

And so coming into the year, what we have highlighted is that, we will not be launching or commercializing any new test in 2025, But as we progress through 2025, we'll start providing additional updates on the progress that is being made. Specifically, we're very pleased with our partnership with Memorial Sloan Kettering and the work that we're doing there. We highlighted some of the presentations that have come out of there. I fully expect that as we progress into the year, Kyle will provide more detailed updates, specifically around risk of recurrence and MRD. And then we've got a couple other things that we're pursuing and exploring that I think provide exciting opportunities for us to continue to leverage this commercial channel and this opportunity to partner in advancing care for those with lung disease.

Kyle Mikson
Managing Director & Senior Research Analyst at Canaccord Genuity - Global Capital Markets

Yes, fantastic. Thanks for that, Scott. Follow-up on that. So can you just provide more info on the VMRD program MSK, just like a reminder, basically refresher, because it seems like it could be based on the test could be based on proteomics and GDPR. And it seems like it could be like a pan cancer test now with the prostate, like illusion that you just provided.

Kyle Mikson
Managing Director & Senior Research Analyst at Canaccord Genuity - Global Capital Markets

So just a little bit of a snapshot before we provide the update I guess in a few months or kind of soon?

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes, very good question. We haven't provided a lot of detail, but you're thinking about it exactly how we are. We had disclosed a few years back that we had discovered a test that we called risk of recurrence. This was a test where we were able to identify those patients that would recur, via a simple blood draw prior to their surgical resection. And then as we entered into the collaborative partnership with Memorial Sloan Kettering, we highlighted that we were gonna prioritize MRD, and minimal residual disease as we know, is a very, very interesting topic, but also a lot of utilization from a test perspective from competitors out there.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

So the way that we're looking at this is we do have the potential to be the only company that would have a pre surgical resection test and a post highlighting those that would have the highest likelihood of recurrence upfront and then monitoring and surveilling those patients to pick up MRD over time. I think what we've demonstrated in some of those early presentations are exactly the direction we're going. We still believe that a multi omic approach is going to be the most impactful long term. That's really kind of been a foundation within biodestics, from a scientific perspective. We think that applies here.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

It's critically important to not only understand what's going on with the cancer or the tumor, but it's equally, if not more important to understand what's going on with the patient and their immune response.

Kyle Mikson
Managing Director & Senior Research Analyst at Canaccord Genuity - Global Capital Markets

Perfect. Thanks, Scott. Again, and then finally, it seems like there could be some key risk quality measure updates possibly this year for lung cancer screening. How would that affect your outlook in 2025 or 2026 if that hits as expected? Thanks.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes, really good question. Just a reminder, we had shared last year that we were expecting updates on the HEDIS measure front, especially and specifically around lung cancer. We still expect that, but I have to be mindful that in the current environment, with all of the ongoing changes and uncertainty within the current administration, HHS and CMS, this is one that we're monitoring closely and we'll give updates if and when we hear of anything related to HEDIS. But if you think back what we'd stated prior, anything and everything we do in a lung disease population to help identify and diagnose patients with lung cancer sooner will have a significant impact. We still function in a world in The United States where less than ten percent of the screen eligible population is participating in screening programs.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

So what we do know is we're not doing an effective job, we can improve. And just like the single cancer early detection or the multi cancer early detection test focused on that screening population, we fully expect this to expand our addressable market in a significant and meaningful fashion. And many of the pulmonologists that we partner with and some that you may have spoken to, they highlight that there's more false positives with those tests, it's going to break them in terms of finding and highlighting those patients that truly do have a malignancy, and most importantly coming out of that is where will they have confidence in sending a patient to CT surveillance and taking a wait and watch approach. So almost every physician we've spoken to has said we play an integral role there and that the addressable market for us is going to expand significantly.

Kyle Mikson
Managing Director & Senior Research Analyst at Canaccord Genuity - Global Capital Markets

Awesome. Thanks, Scott.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thank you, Kyle.

Operator

Thank you. One moment, please. And our next question will be coming from the line of Dan Brennan of TD Cowen. Your line is open.

William Ruby
Equity Research Associate at TD Cowen

Hi, this is William Ruby on for Dan Brennan. Question I have is, what impact do you think the Altitude publication could have on usage and awareness? After it's published, how quickly do you think this will impact if they felt in the market? And do you think that the ALTIGEN study has the opportunity to potentially sway CHEST guidelines down the road? Thank you.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes. Thanks, William. Really appreciate the question. As a reminder, ALTIGUDE is the first of its kind in the pulmonology community. There has not been a prospective controlled trial focused on lung nodule management.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

So to answer your question, with that being the case and then looking at the 26 sites that have been enrolling and who they are whether it's Mayo, Cleveland Clinic, Johns Hopkins, we're working with, the thought leaders in the space. And so, we do believe that it's very meaningful and it will have a significant impact. As it relates to guidelines, we've highlighted that within CHEST or ACCP, the guidelines related to lung nodule management have not been updated in over ten years. What is worth sharing today is that last year towards the end of the year, CHESS leadership actually stated in an open forum that they were well aware of the delay in updates and that they had prioritized it and that updates were coming in 2025. So we haven't heard any material updates or changes in that, but that was the first time that CHF's leadership went out and stated that they were aware and acknowledging it and working on it.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

So we feel pretty confident that we've done a very good job of putting, strong data that's not only useful but compelling out there. We know that a number of the major academic institutions, that help implement consensus statements or guidelines, either have used Notify or are involved in the Altitude study. So for us, a positive, result in the study and publishing that, like any other amount of data that we get out there, it will be helpful. It's really just a question on the timing related around guidelines. But for the first time, I'm able to sit here on an earnings call and state at least, CHEST has acknowledged it and stated that they're working on it and plan to have an update released in 2025.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We think that's a positive. And like anything else, you know, inclusion in guidelines and additional data getting out there, helps the sales team with physicians, but it also helps with payers. And so we're really excited. We think this will be a big year on a data front, which also translates into what we expect with CLARIFY, the new study that we launched.

William Ruby
Equity Research Associate at TD Cowen

Thank you.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes. Thanks, William.

Operator

Thank you. One moment please. And our next question will be coming from the line of Thomas Flaten of Lake Street Capital Markets. Your line is open.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets, LLC

Hey, guys. Appreciate you taking the questions. Scott, not to get too much in the weeds, but with respect to the pilot study you ran last year on the sales force, should we read that as there might be a need to have to maybe further segment your territories to give the reps the opportunity to engage with more primary care docs. Is that an appropriate read through?

Scott Hutton
Scott Hutton
President & CEO at Biodesix

The way we're looking at it, Thomas, is we have 48 territories right now. We're going to add two additional territories this year. We're going to end the year at 50 territories. Within those territories, there's going to be approximately two sales professionals per. We've talked about the expansion that we plan, this year in the sales force.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

So we'll be close to 100, somewhere between that 95 sales professionals and 100 sales professionals, and they will be segmented within those territories. What our sales ops team spends a lot of time looking at is claims data, going back and really looking at payer data and ensuring that we're doing the best we can to track, the referral patterns and the diagnosis of lung cancer in that pulmonology community. And what we want to be very clear with is, you know, this is not us going after all primary care physicians. This is us really looking at it through the lens of our pulmonologist, leaning heavily on them. They know who refers into them.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

They also know the claims data, just like us. And so working with them to make those introductions and have a team that's working to ensure that there's a warm handoff and that we're getting to those patients. So there will be some segmentation. We've talked in the past, Thomas, about having a pulmonology sales consultant, which is the leader, and then in some territories hiring an associate sales consultant. We're going to add this in where we look at it and say, if there's a focus on the general practitioner, that could be a subspecialty.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

It also could blend over into some of the work that the associate sales consultant is doing. Is that helpful, Thomas?

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets, LLC

Yes, no, it's super helpful. And then Robin, just one for you. What's left in terms of upside on the gross margin line? Is it just long term volume that's just going to drive that up on a per unit basis? Or are there other things you're working on to kind of maybe tick that over the 80% mark?

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

Great question. Yes, volume always helps. And so as we grow, we do expect some small incremental improvements. Our team is constantly working on operational improvements. And so while we don't have anything forecasted in for the year, we're anticipating maintaining sort of these already very strong gross margins in the upper 70s.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

We do think there is still some opportunity for improvements, and the team is constantly working to make those changes. So both the operational improvement side and volumes give us some potential in the later quarters of the year and into 2026?

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thomas, we appreciate the question because we've highlighted before that that's pretty much industry leading. And like Robin said, we still think that there's small opportunities here and there to improve it, but proud of having such strong gross margins and eager to continue to improve when and where we can.

Thomas Flaten
Senior Research Analyst at Lake Street Capital Markets, LLC

Got it. Appreciate it. Thank you guys.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thanks Thomas.

Operator

One moment for the next question. And our next question will be coming from the line of William Bonello of Craig Hallum. Your line is open.

Bill Bonello
Senior Research Analyst at Craig-Hallum Capital Group LLC

Hey guys, it's Bill. Couple of follow ups on some of the things we talked about. Just again sort of revisiting this primary care effort. Just trying to understand how you I mean, clearly there's a lot of patients in that channel, but how you sort of think about that and prioritize that relative to expanding presence with pulmonologists that currently are not ordering the test as well as maybe expanding within some of the pulmonologist offices to more fully utilize the test even if they're existing customers?

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes. Thanks, Bill. Great question. We've stated, towards I think it was towards the end of last year that we estimated we were approximately 7% penetrated into this opportunity. So you highlight a great point.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We have tremendous room to continue to grow within the pulmonology community. A lot of this, really the genesis was some of our early adopters who were pulmonologists after gaining experience with, you know, forty, fifty, 60 tests, all of a sudden what they noticed is where there was an inefficiency in their practice was when a referring physician, oftentimes that primary care physician, was referring a patient that did not have notified test results, but also was not appropriate. They were a benign patient that they could have continued to manage themselves. So the genesis of this really started with a few pulmonologists, some were general poems, some were interventional poems, but they started this on their own and asked us to assist them because they reached out into that referral networking community and really looked at it and said, Hey, if I'm an interventionalist, you know, I want you to refer every one of the CDT positives to me as quick as you can. If it is not CDT positive and it's, you know, an XL2 positive, then you go ahead and manage and watch that patient, ultimately surveilling them, more than likely supported with an annual CT scan.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

And if and when anything changes, refer them to me. So because we saw that, we also had a number of physicians that started doing it, at least gave us, you know, some insight to say, hey, there's a high likelihood this could be a success. And that's exactly what we saw. You know, this was not us going out and just blindly knocking on primary care, practice doors. We know they're busy.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We know that they won't have the number of nodules on a daily basis. So it really was a targeted approach. And so I think in time, you'll see a balanced approach where the territories that are more mature and have had more time and more success selling Notify, those are ripe for us to continue to focus on shifting, some of our resources into that primary care referral network. And in the territories, especially West Of The Mississippi, where we still have some sales reps covering large territories geographically, there we'll continue to focus on the pulmonologists because we've seen how this works over a period of time. And we think it's still successful and reproducible.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

It really just is about increasing our access to that really large addressable market.

Bill Bonello
Senior Research Analyst at Craig-Hallum Capital Group LLC

Sure. Okay. That's really helpful. And then maybe just kind of a two parter on the cash and cash burn situation. So you talked about adjusted EBITDA, but not necessarily about cash flow or free cash flow or cash burn.

Bill Bonello
Senior Research Analyst at Craig-Hallum Capital Group LLC

Can you maybe just tell us about sort of your expectation for cash burn for the full year and then maybe how that paces over the course of the year? And then I'm also curious when you talk about being able to reach breakeven, I thought you said with cash on hand, I just want to clarify if that means you think you'll get there without accessing the Perceptive line or the ATM or if you're kind of talking about getting there with the resources that you have?

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

Yes. Happy to go into details. So we believe we can with our revenue growth and our cost conscious approach, we can get to adjusted EBITDA breakeven and shortly thereafter cash flow breakeven with the cash we have on hand. We did amend the Perceptive Tranche C loan to provide access, extend access to that tranche, which if we drew that down would be additional cash on hand would provide more buffer to the balance sheet. We also, as you mentioned, have our ATM, which we put in place in November of last year but have not yet accessed.

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

We anticipate that cash burn always goes up in the first quarter, so we expect to see that in the first quarter. You have the annual bonus payments, resetting of payroll taxes and costs at the beginning of the year, and then steady decrease in that cash burn across the year, culminating in adjusted EBITDA breakeven at the and towards the end of the year in the second half followed by cash flow breakeven.

Bill Bonello
Senior Research Analyst at Craig-Hallum Capital Group LLC

Okay. And just in total sort of what you think the cash burn for the year might be?

Robin Harper Cowie
Robin Harper Cowie
CFO at Biodesix

We haven't guided that number, but we do believe that we can get to cash flow breakeven with the cash we have on hand.

Bill Bonello
Senior Research Analyst at Craig-Hallum Capital Group LLC

Okay. All right. That's very helpful. Thanks. That was all the questions I had.

Bill Bonello
Senior Research Analyst at Craig-Hallum Capital Group LLC

Thank you very much.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thanks, Bill.

Operator

Thank you. And one moment for the next question. Our next question will be coming from the line of Sung Jiyoung of Scotiabank. Your line is open.

Sung Ji Nam
Managing Director, Senior Equity Research Analyst at Scotiabank

Hi. Thanks for taking the questions. Scott and Robin, just a clarification question on the sales force expansion plans. Would you be able to comment on what kind of what inning you're in in terms of at the end of the year with 95 reps and 50 territories kind of in terms of optimizing or rightsizing your commercial structure?

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yeah. Great question, Sung Ji. I referenced us having 48 territories and expanding to 50. So when you look at it that way, territory alignment is pretty consistent. So you kind of look at that and say kind of eighth and ninth inning, we're really secure with that plan.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Because the pilot was the second half of last year, we continued to take a lot of those learnings all the way up and through December. And so as we presented the budget for approval this year, those kind of nuanced changes and adaptations were part of that plan. So we're in the midst of implementing that now. So one way to think about it and it builds off some of the earlier questions as we continue to hire approximately six sales reps a quarter, as we look out on the year about 60 ish percent of those are going to be focused on that primary care physician call point. So we don't have them all in place today, but that goes back to the question that Bill just asked really is, if we can continue to grow and focus on the pulmonologist and we'll do so, we're going to add those primary care specialists, if you will, if and when there's a need and there's a critical mass and volume in those territories, again, where the pulmonologist is guiding us and leading us to help work our way back through their referral pattern.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

So we can time that or gate that over time based upon continued growth and development. Is that helpful?

Sung Ji Nam
Managing Director, Senior Equity Research Analyst at Scotiabank

Yes. Thank you. And also in terms of we're increasingly hearing more about AI and diagnostics. I don't know if that gets overused now, but just given BioDessics uniquely you're uniquely positioned with your multimodal approach, just kind of curious to the extent that you can comment on it, kind of what your current capabilities are there and how you might be able to leverage AI to further differentiate your product going forward over the next few years?

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Yes, it's a great question. You might be right. It might be a phrase that's overused, but we think it's critically important, going forward. We have a long history of utilizing AI and machine learning in both the discovery and development of test and, in our biopharma services offering. So we're big believers.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

We haven't disclosed anything just yet that we may have been working on, but we do plan on participating and continuing to hopefully be a leader regardless of whether that's a proteomic, genomic, a radiomic solution that leans heavily on machine learning and AI. We do think that there's great value. We think there's an opportunity to continue to invest and improve not only your existing portfolio of tests, but really enrich your discovery and development efforts that are fueling your pipeline. So more to come as we progress through 2025, we still have a massive opportunity to continue to grow. We've got laser focus on this path towards profitability, and really all of our efforts are focused on getting to more lung disease patients this year than ever before.

Sung Ji Nam
Managing Director, Senior Equity Research Analyst at Scotiabank

Great. Thank you so much.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

Thanks, Sung Ji.

Operator

Thank you. And that does conclude today's Q and A session. I would like to go ahead and turn the call back over to Scott for closing remarks. Please go ahead.

Scott Hutton
Scott Hutton
President & CEO at Biodesix

In closing, I want to express my gratitude to all the remarkable members of the BioDesk six team who've shown unwavering belief in and dedication to our mission, vision and culture. Our collective commitment and daily contributions are centered around making a positive impact in the lives of patients, And I'm truly thankful for your efforts. Thank you, operator.

Operator

Thank you. This does conclude today's conference call. Thank you all for joining. You may now disconnect.

Executives
Analysts
    • Andrew Brackmann
      Equity Research Analyst at William Blair & Company, L.L.C
    • Kyle Mikson
      Managing Director & Senior Research Analyst at Canaccord Genuity - Global Capital Markets
    • William Ruby
      Equity Research Associate at TD Cowen
    • Thomas Flaten
      Senior Research Analyst at Lake Street Capital Markets, LLC
    • Bill Bonello
      Senior Research Analyst at Craig-Hallum Capital Group LLC
    • Sung Ji Nam
      Managing Director, Senior Equity Research Analyst at Scotiabank
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Key Takeaways

  • BioDesix delivered $71.3 million in 2024 revenue, up 45% year-over-year, with Q4 revenue of $20.4 million (+39%), gross margins of 78%, and a 32% improvement in adjusted EBITDA loss towards profitability.
  • Lung diagnostic testing revenue grew 43% in 2024 (40% volume growth), fueled by five Medicare-covered tests and a successful pilot engaging primary care referral networks, prompting plans to add ~6 sales team members per quarter to reach ~95 reps by year-end.
  • BioDesix launched the CLARIFY study to enroll 4,000 patients (600+ accrued) and compare NOTIFY tests to PET scans, while the ALTITUDE randomized trial is on track with a DSMB review in Q2 and potential data release by year-end.
  • Diagnostic development services saw 70% revenue growth and a $12.2 million backlog (+54%), highlighted by promising Verastat immune-classifier data in metastatic prostate and broader solid-tumor settings.
  • For 2025, BioDesix forecasts $92–95 million in revenue, will maintain gross margins in the mid-to-upper 70s, and aims to achieve adjusted EBITDA profitability in H2 through disciplined expense management and continued sales expansion.
AI Generated. May Contain Errors.
Earnings Conference Call
Biodesix Q4 2024
00:00 / 00:00

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