Hi, welcome to the Canaccord Genuity Global Growth Conference. I'm Kyle Mixon. I cover life science tools and diagnostics for Canaccord . Please welcome me to a fireside chat with Biodesix. Biodesix offers a unique platform to test for many areas of lung cancer, and we'll talk about that today. With the company, we have Scott Hutton, CEO. Thanks Scott for joining us today. Appreciate it.
Yeah, thank you, Kyle.
Maybe for those who aren't totally up to snuff on the company, can you just walk through the business model and some of the products as well as the vision for Biodesix?
Yeah, so we're a blood-based diagnostic company currently with a commercial focus on lung cancer. On our biopharmaceutical partnership and collaboration side, we focus on pan-cancer. As Kyle said, we've got a differentiated offering with five on-market tests, all with Medicare coverage for patients with lung disease. Two of those pre-cancer diagnosis, where we have our Nodify portfolio of tests identifying those patients that are likely malignant or likely benign. Then post-cancer diagnosis, we have two genomic tests and one proprietary proteomic test called VeriStrat, where we really help physicians understand what the ideal or best treatment option might be for those patients.
Alright, awesome. You just announced second quarter results last week, better than we expected. That was after a 1Q update that was kind of had to digest a lot to understand the go forward basically. Maybe talk about the shift in primary care focus and all that that kind of happened more in that 1Q timeframe and what's happened since and why the second quarter shaped out, shaped up pretty well.
Yeah, thank you, Kyle. We were pleased with second quarter performance. We looked at the first quarter as a slowdown to speed up. What Kyle just referenced was adding a focus to the primary care call point. It really is not about calling on the 250,000+ primary care physicians. What we've gained experience with in pulmonology is a better understanding of the referral networks. What we're leveraging here is through the support of our ordering pulmonologists, extending out into their primary care referral network to offer Nodify testing. What that really does is it'll enrich the patient population. A positive Nodify T where you've ruled in with a likely malignant test result now gets pulled to the front and/or referred in as quick as possible to the pulmonologist. What pulmonologists are concerned about is when primary care just refers everyone, their practice bogs down.
They can't find and identify those cancer patients soon enough. Their fear is that it'll delay time to diagnosis. They're really motivated to encourage those primary care physicians to utilize our tests to identify who to refer on. The other extreme would be who do they manage in a conservative wait and watch approach that's supported with an annual CT?
Okay, I think in the second quarter, 9% of the ordering was done by the PCP team.
Yeah.
Is that right?
Yeah.
The rest was the pulmonology. Was that ahead of your expectations? Is that a pretty good number to stay with, like 10% or so of ordering or higher?
Yeah, I think it'll continue to grow and expand. Because we're really leaning heavily on the pulmonology network, we were pleased and we were encouraged. We were received really well into the primary care call point. We think that'll continue to expand. We'll continue to keep everybody updated. It's still early. We've made a lot of progress. We're being received well. Most importantly, primary care, when we walk in, they say, "Thank goodness you're here. We have a big problem." What we really knew was 50% of the patients were stuck in primary care. When we looked at how large the addressable market was, we were only accessing about 50% of that. Now we've opened that up. We'll continue to report out, but that early reception is very positive. We're encouraged and we're excited to continue to build on the momentum that we've got.
Okay, and then talk about the sales force that's just really focused on primary care at this point. Is that growing it out, I guess? How's that been?
Yeah, we hired, we recruited and hired that team, brought them on, put them through training in the second quarter. They didn't even have the full quarter. For us, it was a minimal amount of time that they could contribute. They came out of the gates performing exceptionally well. We continue to model and see them performing consistent with our pulmonology sales force. Getting to a point in time where they can pay for themselves in about three months, that ramp has been consistent. We're excited to continue to prove that out. Sales rep productivity has remained consistent across both areas of specialty also.
Great. I know in the first quarter, it was a little bit of a hiccup, I guess, with the strategy, but ultimately this is going to be, you know, additive incremental to the pulmonologist kind of opportunity that you previously had. Now you just kind of layer on this, you know, primary care kind of referral aspect as well.
Yeah, that's right. It really isn't a deviation. It's just an expansion. That's why I use the phrase slow down to speed up. Slowing down allowed us to intentionally go out. We stated in the first quarter that we had done a pilot last year to explore this. We had a lot of wonderful learnings. We applied those this year. Those learnings have remained consistent. Because it is early days, we'll continue to learn. I'm certain of that. The new hires have come on board. They're eager to be here. Most importantly, we're being received exceptionally well. We're not having to convince primary care physicians that they have a problem. They know they've got this problem. What pulmonologists told us is they need that type of testing to better know and assess who to refer on.
Okay. Overall sales reps, I think you're in the 70s now. You want to get to mid 80s in the third quarter, like on average, and then the mid 90s basically in the fourth quarter. Would you like to slow down on that kind of hiring path?
No, we've right now we're at about 74. To your point, we expect to be at 85 at the end of the third quarter, 95 at the end of the fourth quarter. We feel confident that getting back to that was kind of a prior plan, that there's a tremendous opportunity for each and every one of those territories and resultant sales reps to grow and contribute. Again, monitoring that sales rep productivity and that time to ramp. As long as that remains consistent, we feel very good that it's the right thing to do. We know that sub 100 sales reps, we're still barely scratching the surface, right? We're less than 10% penetrated into the opportunity.
The more feet on the street we can get, the sooner we can get out in front of some of those physicians and start increasing our orders not only through number of sales reps, but also same order sales that start to increase.
Okay. At least 10 of these 74 reps that you have now or that you had at the end of the second quarter aren't fully trained, obviously. That'll take multiple quarters. How much runway do you have with some of these? How much more can you get out of these reps, let's say? You would think that growing a team at 95 reps is pretty good. Most companies might be happy with something that large, let's say, if there's a revenue base at this level.
Yeah, you know, the one thing that we know is that in urban areas where it's densely populated, especially here in kind of the Northeast, we've been stable there. We've grown, we've expanded, we've decreased territory size. We've seen sales rep productivity numbers shoot through the roof. West of the Mississippi, we still have some territories that are really large. When they're that large, we know that the cost burden is going to be a little bit higher, possibly going to be a little less effective on a daily basis, especially if they're spending time in the car or traveling and have overnights. We want to be very consistent about continuing to cut territories and narrow them down to minimize travel time, but we want to do it at the right time.
Part of that is the education and continuing to publish and get data out there so more and more physicians are comfortable and familiar with us. When it comes to primary care, we're just now introducing ourselves really to that call point. That'll take a little bit of time. We feel confident that we can continue to scale. We'll continue to leverage the sales force we have. As long as sales rep productivity remains the same, we feel good about the remainder of 2025 heading into 2026.
Okay. On the topic of productivity, you're talking about calls per rep and touch points per rep. How does this, like the digital order—I know digital ordering was pretty strong in the second quarter. How is that kind of helping results?
Yeah, in case everybody's not familiar, there still are medical practices out there that are paper-based. They are utilizing fax to order. That's not just for us. That is for every company out there. We deal with it. The example I'll give is if somebody faxes in a test request order, we have no ability to give them real-time feedback. If that test request form is missing any data or content that we need, we have a customer service representative that gets on the phone. What I'm describing ultimately starts to be a delay. It takes time. Utilizing our internally developed physician portal, which is like an app on your phone or an iPad, or utilizing EMR integration, we have the ability to ensure that all the right content is in when the order is placed.
Not only does it make you more effective and more efficient, it increases the reorder rate. We've been able to demonstrate that. Part of it is customer satisfaction. It's not whether a nurse or a physician inputs something wrong, but if it's missing data, they don't even know that it was missing data. In their mind, it's now delayed. What we really want is we want to increase that quote unquote stickiness. We've demonstrated that. When we've converted somebody from paper or fax to our portal or EMR, we've seen reorder rates increase. We'll continue to offer that. You've got to be easy to do business with, and each and every physician's office and practice is slightly different. We'll continue to offer each of those, but when given our preference, we push everyone towards a portal or EMR integration.
All right. Those investments to integrate with the EMR, are those already done or is there further work to just get connected to more EMRs, for example, and then streamline this whole process even further?
Yeah, specific to EMRs, there is more work to be done. As an interim step, though, the portal or the app, there's no work to be done there. That can be implemented today. What needs to be done with the EMRs is even if you have broad EMR integration, each site has to enable it or turn it on, if you will. That can take some time. That is out of our control. Oftentimes when we meet with a clinic or a practice, they'll say, "Hey, this is a top priority for us." You go to their administration and they're like, "Yeah, there's 15 priorities and this is 12th," right? It's going to take a little time to get there. In those instances, we would rather get somebody on the portal ordering now while we work on the EMR integration. We've worked with a number of different EMRs.
We've worked with some integration partners and providers, and we feel like we've got a multitude of options to meet everybody's need. A broad system-wide integration doesn't really work where you push it out to everybody. They have to enable it at the site.
Got it. Okay. Just shifting gears a little bit to the biopharma kind of side of the business. It's definitely smaller, but it's interesting. I think you basically exited the second quarter with the largest revenue under contract, but not yet recognized as revenue for the company. It was $12.5 million. What's driving success there? You have a bunch of pipeline products that might be helping there. Is this biopharma business becoming bigger and bigger and more material for you?
Yeah, and I'm really proud of the biopharmaceutical team. It's a smaller team. Internally, we like to highlight that they have the highest sales rep productivity because of the size of the team. It's based on a number of things. One is consistency. We haven't had turnover. We've had the same team. That is a relationship business. It takes a while to build trust. It's an extension of your development team, both in who they are as individuals in terms of what their expertise may be, but competence in delivering results. What we have seen over time is an increase in continued business or reorders, if you want to think of it that way. If we can work with a pharmaceutical company on an early stage discovery effort, we're seeing more of those lead to follow-on testing.
What it's also demonstrating is our ability to function as not only just a solution provider, but we're doing development efforts for them. We're developing bespoke assays for them. We're not just utilizing our portfolio of tests we have. Our discovery and development team, I'm biased. I think they're world-class, and I think others are starting to take note. You might have seen the recent announcement where Thermo referenced us as getting their Genexus NGS platform through the FDA. We were the provider that did that research work and collaborated with Thermo over the years. We've got a number of others that I can't disclose that are in the works, but I think it's just a culmination of a lot of good hard work. It took a little time, more and more starting to pay attention to what we're delivering.
Offering both genomic and proteomics also differentiates us. It isn't just offering proteomic solutions. We think of ourselves as a commercial leader in proteomics, having three on-market tests that have extremely high throughput and strong gross margins on the proteomic side. That is not consistent across diagnostics. I think some of those parties are starting to take note of that also.
Okay. Just thinking about the pipeline still, you've announced over the years like a bunch of non-commercialized tests, basically. You obviously have an MRD test that's in development with MSK . How should we think about that one relative to the risk of recurrence or some of these earlier ones that maybe you're working on less or postponed or maybe you're not even focused on anymore? When also could we hear maybe an update on some of these tests?
Yeah, it's a great question. We as a smaller diagnostic company have been focused on getting to profitability. We were mindful about 18 months ago that we were not going to push forward and commercialize any tests that didn't have a reimbursement, a near-term reimbursement pathway. We continued to offer those tests and assays to our biopharma partners in an RUO capacity. We've continued to make a lot of progress. One area that you've talked about is MRD, where we've partnered with Memorial Sloan Kettering. Here we have merged two development efforts. Years ago we had highlighted that we discovered a test that we named Risk of Recurrence. This is a pre-surgical resection blood-based test, proteomic in nature, where we could identify those patients that would recur. That's different than an MRD test where you're doing the blood draw after.
Because it's proteomic, what we've decided is to merge that with our MRD efforts and have a kind of a joint proteomic-genomic effort for MRD, where we'll have the insights of both genomic and proteomic pre-surgical resection and post-surgical resection at multiple time points. That test will be available in an RUO capacity for our biopharmaceutical partners by the end of the year. We're working diligently on getting that ready to go. We're grateful to have the partnership in collaboration with Memorial Sloan Kettering, which is bringing in their biomarker development team and their insights. It's also enabled us to keep development costs down, where they're providing samples, patient outcomes. We're providing the laboratory team and the equipment. We're seeing that team in Colorado on a quarterly basis, if not more, to make as much progress as possible.
Because we're just now going to introduce it in an RUO capacity, we don't plan on commercializing that test in 2026. We're hopeful to give an update on what that commercial timing looks like closer to the end of this year, beginning of next.
Okay. Not on your term thing, but just to understand it better, it would be like, is it like the two tests are always being done before and after the surgical resection, or is it like a reflex kind of?
Yeah, always, right? We look at it and say that pre-surgical resection blood draw is going to be critical, and it's going to tell you a lot. I should also offer, this is not NGS-based. We're going to use a PCR platform where sensitivity is higher and your turnaround time is more rapid. We can keep costs lower that way. For us, we've got a longstanding relationship with Bio-Rad and collaborating with them. We're working with them. Memorial Sloan Kettering is collaborating on that also. We do actually have, I can't name them, but we have a major biopharmaceutical partner that's working with us on that also. What gives us confidence is our experience, but also looking at who those partners are, the insights they're bringing to the table, their experience with the tests that are on market now, and giving us development opportunities to improve upon the current offerings.
We won't be a market leader. We won't be first to market, but we plan on offering a very competitive and compelling offering.
Okay. R&D expenses in general, you know, ticked up a bit recently. How much of that is like your own clinical study, like, you know, output and investment versus, you know, developing these kinds of like pipeline tests, which you have other ones, I think, as well?
Yeah, we do. On that front, one that I should reference is I mentioned that we really focus on pan-cancer when it comes to those development efforts. One that we're really focused on right now is VeriStrat, which was the first test that Biodesix discovered. We're also working with Memorial Sloan Kettering on a prostate indication there. What most don't appreciate is we did initial research on VeriStrat going back to 2015 in nine different disease states. We know where the test worked. We just put that on the shelf because we were focused on lung cancer. This is not a test that we would sell within our commercial channel. We'll look for partners and allow them to sell that. VeriStrat has demonstrated that it's a very robust test. We're eager to get that submission out there. We do plan on submitting that to the FDA.
That'll be a little bit different of an approach there. Going back to your question on R&D expense, there was a little bit of that expense related to the VeriStrat push that we've made recently, especially to get it ready to submit to the FDA. The majority of that was related to CLARIFY. That was the new retrospective chart review study that we kicked off last October. As a reminder, the goal there is 4,000 patients enrolled. The value here is, even though it's a retrospective study, not a prospective, we have outcomes data. ALTITUDE, our prospective trial, we've stopped enrolling, but we still have to watch and see outcomes over a one to two-year time horizon. Because of our commercial and clinical success, we can go out and pull patient charts and actually see how the test performed in the real world.
We have over 1,100 patients already enrolled in CLARIFY since October. We're planning on continuing to prioritize that and accelerate it. We're hopeful to have an interim analysis that is occurring right now that we can actually submit something late-breaking to CHEST and get it out there in the October meeting. Added expense increased, but we see a near-term return. Some of the things we're looking at in CLARIFY are how does utilization of our test and our test results compare to PET? Are we changing physician treatment behavior or decision-making? Also seeing how it's holding up in the real world in terms of test performance. Tons of other opportunities for us to get that out there. That really was related to CLARIFY. We won't see a decrease in R&D expenses that's related to ALTITUDE because we still have to continue to keep those sites open and monitor those patients.
Are either of those studies, you know, guideline inclusion driving possibly?
Yeah, you know, guidelines in the CHEST society or in the pulmonology community are interesting. If you're not familiar, they have not updated guidelines in over 10 years. They went on record last year and said they plan on updating guidelines in 2025. As you can imagine, if as a physician society, you haven't updated your guidelines in 10 years, you've got a lot of catch-up work to do, and it's difficult. We were never focused on one singular study that we thought would get us guideline inclusion. We've always said, develop as much data and content as possible, be the market leader, and give them as much data as they need to make a decision. Because they haven't made a decision, we don't know. You could make a statement that we've already done enough to be in guidelines. We won't know that until they actually update the guidelines.
At this point in time, because they haven't, and the CHEST meeting occurs in late October, I think that's the next time we'll get an update. We think we've done enough. We also know through the 26 different major academic institutions that we partnered with on ALTITUDE that we're working with some of the preeminent thought leaders in the space, and a number of them utilize the test commercially also. We feel like that speaks volumes, or at least gives us confidence that we're on the right track.
Okay, and kind of on the note of guidelines, just today I saw there was, I think it was bicameral support, the elimination of cost sharing for certain types of lung cancer screening. I don't know if you saw that, but how does the upstream, kind of the impact on these upstream things that have to do with lung cancer screening really affect your business, which is much more nodule kind of facing?
Yeah, you know, we haven't factored any of that into our plan because they've been on again, off again, a number of these, even the HEDIS measures. It is only upside. Right now, the Nodify test, patients are eligible for Nodify testing regardless of whether they were identified in a screening program or through an incidental finding. The best estimates you can find in the United States right now are about 10% of screen-eligible patients are participating in a screening program. We've got nothing but massive room for growth and improvement there. Whether it's a blood-based screening test, which a number of companies, some of which are here this week, are working on, we're big fans. We're big supporters of that. We've got to get to those patients earlier if we want to make a significant difference and positive impact. The challenge really, Kyle, is the infrastructure.
When you talk to a pulmonologist, they don't feel confident right now that they can handle those increased volumes. They don't know what they're going to do with that. When you've got 10% of your eligible population maxing out a screening implementation system, what are you going to do when that's 50%? They struggle with that. I think we saw that as a broader society. Was it about four weeks ago? The HEDIS measures, which were supposed to begin implementation for lung later this year, have now been put on hold. The statement was, this is complex and difficult. One of the things they cited is they don't have the infrastructure. They think they'll break the system. The second thing is one of the first reasons that a patient is there is because they're screen-eligible. That starts with having a smoking history.
Their fear is that's reliant on an honest response from a patient. They don't think patients will be compliant with that. There's a number of other factors. For us, any and all of those efforts increase awareness. They increase, you know, sadly, they increase the number of eligible patients for testing. It doesn't necessarily mean we're going to get to those cancers sooner. We look at it and say our opportunity only grows and expands as others have success. Whether it's guidelines that are updated, whether it's HEDIS measures and/or screening adoption improving, also as we see those screening tests get commercial access, it's going to benefit us. We just don't control the timing.
Okay. On your balance sheet, you have around $20 million cash or so. You have material debt, you're burning $5 million- $10 million a quarter. What are your options to kind of ease the cash burn, and what levers can be pulled to help that, to cushion that, let's say, as you, I think you're nearing adjusted EBITDA profitability soon. How do you, given this debt, I mean, how do you think about refinancing or paying it one day? What are some thoughts, given it's relatively near term?
Yeah, I think we are exploring as many different options as possible and we're always weighing what those are. We've had an ATM that's been open. We've got a wonderful debt partner and provider. They've also been huge supporters of ours on the equity side. Our insiders and existing investors remain exceptionally bullish, and we've got levers to pull. It's really being mindful of what's the cadence. How do we thread this needle? We're realistic. We look at the current stock price and we know that any sort of fundraise is going to be exceptionally dilutive to those loyal supporters that we've had. We're going to be opportunistic, but to your earlier point, we can get there, right? We just don't want to get there with fumes in the tank. I think we've got a very compelling story. We talk about the R&D opportunities.
We want to be able to continue to fuel future growth and continue to differentiate ourselves. I think on the debt front, it's pretty easy to say from a debt to equity ratio, we're not going to look to pull down more debt. We've got a good partner. We're not looking to pay that off. We'll continue to work with them. The whole goal is growth. We're not trying to save our way to prosperity here. It's fuel growth, continue to expand the sales force, get to adjusted EBITDA break even, and then shortly thereafter, cash flow positivity. We think as we do so, we're going to continue to differentiate ourselves, but also demonstrate that we're going to be here for the long haul.
Okay. Beyond that note with the stock price and everything, what's something that either investors aren't appreciating right now about Biodesix? We talked about the opportunity, but clearly I don't think it's being followed enough. Also, why might you prove people wrong in 2026?
We might prove people wrong or we will prove people wrong because of the team we have. We've built a very resilient team. We're motivated to get out and positively impact, you know, the lung disease and lung wellness space. I think where we are underappreciated and undervalued is on our development and discovery capabilities. We've done it for years. It's kind of a self-inflicted scenario where when we, you know, pull back on the investment there, it delays introducing new tests. We want to be very mindful. Again, every dollar spent needs to go towards profitability and sales growth. We know that people underappreciate the business model today because we have an industry-leading gross margin at 80%. There's only one other diagnostic company that's even in the ballpark. We can maintain that and keep doing that for quite some time.
I'd like to see us, and we have highlighted that we plan on doing an R&D day. I'd like to see others start to pay a little bit more attention in terms of what we're capable of continuing to contribute from a development perspective. I think that research is critically important. We'll have that day in that audience, and we're eager to do so.
All right, great. Thanks, Scott. Thanks for the day.
Yeah, thank you, Kyle.
Appreciate it.