Biodesix Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 13, 2025

There are 10 speakers on the call.

Operator

Please be advised that today's conference is being recorded.

Operator

I would now like to hand the conference over to Chris Brenzi. You may begin.

Speaker 1

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

Speaker 1

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?

Speaker 2

Thank you, Chris, and thank you all for joining us today. At Biodesix, our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. We leverage a multimodal approach that includes genomics, proteomics, and radiomics combined with AI to discover, develop, and commercialize innovative diagnostic tests for physicians, biopharmaceutical, life sciences and diagnostic companies to help improve patient care. In 2025, we are focused on three main goals, growing our top line revenue, improving operational effectiveness and efficiencies that will result in a positive adjusted EBITDA in the fourth quarter and advancing our pipeline for future growth and expansion. In the first quarter, we made progress on all three by growing revenue by 21% year over year, all while decreasing our year over year spend in SG and A, improving our already strong gross margins by 80 basis points to 79.4 and presenting clinical data on multiple pipeline products.

Speaker 2

Lung diagnostic revenue, which grew 18%, was our sixteenth straight quarter of greater than 15% year over year growth. Starting with the clinical offering in lung diagnostics, our major focus is on lung nodule management, where nodules are either found incidentally when the patient has an image taken for another purpose, or during lung cancer low dose CT screening. Throughout last year, a growing number of ordering pulmonologists provided feedback that our NotifyXL2 and NotifyCDT test may better address gaps within lung nodule management if they're ordered upstream within their referral network. This would help optimize the referred patient population by identifying those at higher risk of lung cancer that should be referred on to the interventional pulmonologist, while lower risk patients remain with the primary care physicians for monitoring. As noted in our last earnings call, we conducted a commercial pilot in the second half of last year to assess the viability of expanding into the pulmonologist referral network, which mainly consists of primary care physicians, where claims data shows that fifty percent of the patients with nodules are managed.

Speaker 2

While there's a large number of primary care physicians practicing in The US, a limited group of approximately 15,000 primary care physicians provide care for approximately eighty percent of those patients who are managed at primary care. The concentrated nature of the nodule referral network and support of the pulmonologist means we can reasonably access those patients with nodules in the primary care setting. As a first mover in lung nodule diagnostics, we have the responsibility to build this market, which will increase patient access. As a reminder, historically, pulmonologists do not routinely order blood based tests for their patients, and therefore, typically do not have phlebotomy services on-site. In order to integrate into pulmonology practice workflow, there are a variety of logistical challenges that must be overcome, such as appropriate patient identification, facilitating test ordering through digital means, including EMR integration, and coordinating blood draws.

Speaker 2

Since the launch of Notify, we have developed a nationwide mobile phlebotomy network to support those physicians who do not have on-site phlebotomy capabilities. Additionally, in 2023, we introduced the Tasso capillary blood draw device, which enables on-site blood collection. Not surprisingly, completing blood collection on-site before a patient leaves the facility results in thirty percent more tests delivered than if the patient leaves and needs to schedule a blood draw at another time. Similarly, since notified launch, we've expanded our digital test ordering capabilities through our Biodesix physician portal and early EMR integrations. In 2024, we contracted with Redox, an EMR integration specialist, to enable efficient and cost effective site level integrations.

Speaker 2

Based on our portal adoption and early integration efforts, we've seen success, and our digital ordering has increased by 58% over the last year. Customer retention in those who utilize digital ordering is 40% higher than those who do not. We're still only scratching the surface with digital integrations. However, this is a costly endeavor. As we balance our cost disciplined approach with the need to expand and accelerate the number of physicians utilizing digital ordering, we have selectively engaged additional EMR providers for broader and more significant EMR integrations in 2025 and beyond to facilitate streamline test ordering.

Speaker 2

During the primary care commercial pilot in the second half of twenty twenty four, we gained critical information about primary care practices, not only in how they manage lung nodules, but also their familiarity and expertise with incorporating diagnostic testing into standard practice, particularly blood based testing and access to phlebotomy services, all of which is now guiding our primary care commercial strategy. While EMR integration is an important driver in all practice types, primary care providers already have processes in place for ordering diagnostic testing and phlebotomy services to facilitate blood draws on-site, which is expected to relieve some of the logistical challenges we've been working to overcome in pulmonology. As part of the primary care commercial strategic effort, we have shifted to a territory based sales approach. The territories are anchored by a senior pulmonology sales rep with primary care sales reps and associate reps providing support and driving adoption across specialties and care settings. In the first quarter, we reconfigured our sales team from 71 sales reps in the fourth quarter to 65 sales reps in order to accommodate the territory based approach consisting of 49 territories with 49 pulmonology sales reps and 16 associate sales reps.

Speaker 2

Average sales rep productivity remains strong at an annualized $1,000,000 of revenue per rep throughout the reconfiguration. Additionally, in the first quarter, we began recruiting the new primary care sales reps. The profile of the primary care sales rep, as well as their onboarding and sales training are slightly different than that of the pulmonology rep. We've taken a cost conscious, mindful approach in recruiting the right Biodesics team members to support the expanded market touchpoint. Hiring the right team has taken more time than we had originally anticipated, putting us one quarter behind plan in hiring and, therefore, revenue, which will impact our guidance.

Speaker 2

Robin will provide greater detail on adjusted revenue guidance later on the call. Historically, we have planned to hire six sales reps per quarter. To support this new plan and catch up starting in the second quarter, we're now planning to hire 10 sales reps per quarter, ending the year with 50 territories covered by approximately 95 total sales reps in the fourth quarter. Overall, we believe reconfiguring our sales team in this way will allow us to continue building this market and increasing patient access in both pulmonology and primary care. With a lung focused sales team in place, we are continually looking for ways to further leverage this commercial channel.

Speaker 2

A complementary area we've been evaluating is radiomics and digital diagnostics. Imaging is a critical tool in diagnosis and monitoring of lung disease, and AI tools are being developed to augment clinical workflows and decision making across a range of indications. Our near term interests are in applications to better identify nodules and images and help identify the risk of cancer for those nodules. While the potential clinical utility of digital diagnostics is obvious, the practical application of how these AI based tests could fit into a physician workflow was an area that we needed to better understand. In addition to the primary care commercial pilot in the second half of last year, we also ran a commercial digital diagnostic pilot to assess the specifics of adding these type of tests into our portfolio and the physician workflow.

Speaker 2

As a result of the successful completion of the commercial digital diagnostics pilot, we are pleased to welcome Doctor. Michael Tamer as our head of radiomics. Doctor. Tamer brings biomedical and experience exploring the benefits of integrating imaging and blood based biomarkers. Radiomics is an integral component of lung care, and we're now uniquely positioned to combine AI and radiomics with the biological insights provided by our blood test.

Speaker 2

We'll provide more details on these efforts in coming months. Turning to our pipeline. Our goals are to develop new tests and expand indications for existing tests. Our current pipeline consists of a new combination MRD test that combines genomic MRD with our proteomic risk of recurrence test and expanded indications for Veristrat, including into other tumor types and into immunotherapy selection. At the third molecular medicine Tricon in March, and again at the AACR annual meeting in April, we provided updates on the approaches we're taking in MRD, specifically the inclusion of our genomic and proteomic tests as measures of early clinical endpoints.

Speaker 2

This approach is unique from other MRD tests, and that it combines our genomics and proteomics platforms. The proteomic information from our risk of recurrence test provides insights into the patient's immune profile, while the tumor informed genomic component leverages ddPCR for disease monitoring. The test will be offered as a complete package and not separate genomic and proteomic testing. We expect this test will be available for use by biopharma through our development services offering by the end of twenty twenty five. As we continue to make progress, we will provide updates on the potential timeline for commercial launch, including revenue expectations.

Speaker 2

Turning to Verastrat, data was presented at both the AACR liquid biopsy meeting and the molecular medicine Tricon meeting on our pioneering immune classifier. Verastrat has been studied in nine solid tumor types over the last twenty years. And the new data was in metastatic castrate resistant prostate cancer. The data showed that Verastrat stratifies patients who are more or less likely to respond to standard of care hormonal therapy. Technical methodology data from this study will also be presented at the upcoming American Society for Mass Spectrometry meeting.

Speaker 3

For new tests and indications we develop outside of our commercial lung focus, we plan to partner for distribution or out license of these products for commercialization. In addition to the new prostate hormonal therapy indication, new data on the use of Verastrat in immunotherapy and chemo combination treatment from the prospective registry study INSIGHT will be presented at ASCO entitled, Host Immune Classifier to Predict Survival with Chemo Immunotherapy in PD L1 greater than fifty percent metastatic non small cell lung cancer. In

Speaker 2

addition to this data, new preliminary results from another study showed that Verastrat may also be valuable in predicting response to immunotherapy in a wide spectrum of metastatic solid tumors. It is clear from this data that the test and its ability to assess patients' immune status is a versatile and powerful tool. And as a result, we plan to continue studies expanding the indications for use of Verastat. Based on the strength of the immunotherapy data, we have replaced the Biodesics primary immune response test in our pipeline with the expanded Verastat immune therapy indication. In addition to the data being presented on our pipeline, we are continuing to make progress with our studies for our on market products.

Speaker 2

The CLARIFI study is a retrospective chart review evaluating the use of notified testing in real world clinical practice, expecting to enroll approximately 4,000 patients. Since launch of the study in late October twenty twenty four, we've already accrued 800 patients and are on track to release interim data from the study in the second half of this year. Finally, enrollment and patient follow-up in our prospective randomized clinical study, altitude, is progressing well under the supervision of the data and safety monitoring board. We'll provide additional updates as they're available. We know there's been a lot of new information provided on our pipeline and data.

Speaker 2

Due to this, we're planning an r and d day in the fall to provide greater insights into the progress being made. More details to come. Moving to development services, we continue to see strong interest in our service offering that leverages our multi omic approach and R and D expertise to help deliver insights that our biopharma, life science tools and diagnostic partners use to personalize patient care and help improve disease detection and treatment evaluation across various disease types. In addition to delivering $1,700,000 in revenue in q one, growing 61% over Q1 twenty twenty four, the pipeline has continued to develop with the team exiting Q1 with $10,900,000 under contract, but not yet recognized, representing a 21% increase over Q1 last year. Overall, we're very encouraged by the continued strong year over year growth in this business and believe there's a significant potential for upside as both existing business and additional opportunities mature.

Speaker 2

In addition to the operational improvements already mentioned, we continued our efforts to improve business processes, laboratory operations processes, and revenue cycle management. As I highlighted at the beginning, our focus on improvements and cost containments resulted in operational leverage such that we grew revenue by 21%, all without growing SG and A. We delivered significant advancements in our pipeline with a very modest increase in the number of dollars spent in R and D. We grew our already strong gross margins and continued improvements in adjusted EBITDA on our path to profitability. With that, let me turn it over to Robin to review our financial performance for the quarter.

Speaker 2

Robin?

Speaker 4

Thanks, Scott, and good afternoon, everyone. First quarter total revenue was 18,000,000 a 21 increase over the prior year. Lung diagnostic testing revenue in the first quarter of twenty twenty five was $16,300,000 from approximately 13,800 tests, as compared to 13,800,000.0 from approximately 11,900 tests for the first quarter of twenty twenty four, representing 16% growth in test volumes and 18% growth in revenue. While the first quarter was impacted by normal seasonality, abnormal weather, and fire events, and the respiratory illness season, our lung diagnostic test volume was mostly impacted by the number of sales reps we had in the field. Development services revenue was $1,700,000 in the quarter, representing 61% growth over the first quarter of twenty twenty four.

Speaker 4

We ended the quarter with $10,900,000 under contract, but not yet recognized as revenue, which is a 21% increase over the prior year. Turning to operational effectiveness, we continue to make strong progress. Our gross margin percentage in the first quarter twenty twenty five was 79.4%, up from 78.6% in the first quarter of twenty twenty four. Even with the existing macroeconomic uncertainties, we expect gross margins to remain in the upper 70s through the rest of the year. Overall operating expense, excluding direct costs and expenses, was $23,400,000 in the first quarter, which was a 3% increase over the first quarter of twenty twenty four.

Speaker 4

Cost containment and operational efficiencies resulted in a year over year decrease in SG and A of 1%. Total SG and A was $20,400,000 versus $20,600,000 despite having 10 more sales reps in the field in the first quarter of this year versus last year. The minor increase in total operating expense was driven by an increase in R and D expense of $900,000 from $2,900,000 versus $2,000,000 due to the investment in clinical studies to help advance adoption of our lung diagnostic tests and advancement of our pipeline. Net loss for the first quarter twenty twenty five was $11,100,000 an improvement of 18% year over year. Adjusted EBITDA, which excludes non cash and other one time items, was a loss of $6,200,000 which was an 11% improvement year over year.

Speaker 4

We ended the quarter with $17,600,000 in unrestricted cash and cash equivalents, as compared to $26,200,000 at the end of fourth quarter twenty twenty four. Cash used in the first quarter includes annual cash payments for accrued expenses, such as payments for short term incentive compensation plans and royalty payments. Subsequent to the end of the quarter, we drew down on the $10,000,000 tranche C loan from Perceptive Advisors, increasing our cash reserves to a pro form a cash balance of $27,600,000 thus strengthening our balance sheet. Based on the existing and anticipated hiring of our sales team, we anticipate an acceleration of growth in the second half of twenty twenty five. As Scott discussed, based on the reconfiguration of our sales organization, we had 65 sales reps in the first quarter versus 71 in the fourth quarter of twenty twenty four.

Speaker 4

Based on the number of reps in the field in the quarter and the subsequent hiring delay, our commercial expansion is approximately one quarter behind our original plan. Including the results of the first quarter, and then shifting of the sales rep hiring and strategy implementation, we are revising revenue guidance to 80,000,000 to $85,000,000 for the year. Because of strong gross margins and cost efficiencies, in combination with the new rep hiring plan, we expect to achieve adjusted EBITDA positivity in the fourth quarter. Now I'll turn it back to Scott for some closing thoughts before the Q and A.

Speaker 2

Thank you, Robin. To summarize our achievements over the last few quarters, we have continued to develop the pulmonology diagnostic market moving from early adopters into early mainstream users. We have grown test volumes from pulmonology year over year. We have conducted two pilot programs to explore expansion of our sales efforts through the pulmonology referral network into primary care and radiomic digital diagnostics. We have maintained average sales rep productivity in excess of $1,000,000 revenue per rep.

Speaker 2

We have leveraged learnings from the primary care commercial pilot to reconfigure our sales organization and begin implementation of the referral network strategy that will expand our access to the

Speaker 3

total

Speaker 2

market. We have controlled cost and gained operational efficiencies to increase our already high gross margins and gain operational leverage. We have advanced our radiomics and AI efforts, and we've presented data on our pipeline of tests for future growth and expansion. I'm also proud to share that for the second year running, Biodesics has been recognized as a top workplace in 2025. While we look forward to sharing more specific details in coming days, I can say that winning another award like this speaks volumes about our team and culture.

Speaker 2

Before moving on to questions, I want to restate that we have the best lung focused team in diagnostics and continue to make significant progress in building a market in an area that has not historically used diagnostics in the way that other medical or oncology specialties have. With first mover status in lung nodule management, and an ever increasing body of robust clinical and health economic data, we are generating the momentum to drive greater clinical and payer adoption as we move through 2025 and beyond. With all this happening, it's a very exciting time here at Biodesics. We look forward to sharing more with you in the coming quarters. Let's now move to questions.

Speaker 2

Operator, let's start the q and a session.

Operator

Thank you. And our first question will be coming from Dan Brennan of TD Cowen. Your line is open, Dan.

Speaker 5

Great. Thank you. Thanks for the questions. Maybe the first one, digging into the sales force changes or rather the kind of bit of slower hiring there. Mean, Scott and Rob, can you just elaborate a little bit on what was different about hiring these PCC sales reps than you anticipated and kind of the confidence level in the new guide that you provided?

Speaker 5

Kind of any more details you can provide would be great. Then I have a follow-up.

Speaker 2

Yeah, thanks, Dan. As we stated in shifting from a pulmonology focus into the primary care focus, what needed to be discovered was target hiring profile, background, experience, network. So, we worked through that. We've continued to apply those learnings. And throughout the recruiting process here in the last few weeks, we've also continued to hone in on that ideal profile.

Speaker 2

Additionally, we're new to them. If you think about it, we've been building a pulmonology focus so those that have experience in lung or with pulmonologists became aware of Biodesics. The general practitioner sales consultants or those with experience and relationships in that network, we were new to them. So it took a little while to introduce, to share our strategy, to get them comfortable with it. And since then, we've made significant progress, and we feel very confident and comfortable that we've got the right hiring profile and the right target, and we're moving forward as rapidly as possible.

Speaker 5

And then in terms of the leadership there, is it the same leader, Scott, kind of who sits atop both pulmonologists or the PCP? Or do you have like a distinct subunit leader for the PCP side given the different profile of those salespeople?

Speaker 2

Yeah, great question. No, we've kept the same leadership team and structure. Internally, we're referring to this as a pod based structure. So, in each of those 50 territories, as we stated, we'll have 50 pulmonology sales consultants. Those really are going to be your more senior sales professionals.

Speaker 2

We'll have a number of associate sales consultants supporting them, and also the primary care sales consultants will be supporting those pulmonology focused sales reps. So your regional sales directors and your area vice presidents will remain the same, and everybody will report up to them.

Speaker 5

And did you guys discuss like what the outlook is for Q2 versus the back half of the year? I know you said you're one quarter behind, but the number of reps you're looking to hire remains the same by year end. So it's like you're planning to catch up. So I'm just wondering if there's any color on the expected pacing given that revenue per salesperson math.

Speaker 4

Yeah, absolutely. We have a pretty good sized class of reps that are finishing up training, and will be going live here soon in the May, beginning of June. We anticipate that we will have an average of 70 to 75 reps in the second quarter, and then are looking to be in sort of the 85 range for third quarter and 95 for fourth.

Speaker 5

In terms of what you've learned so far on the PCP side, any early color on the ordering pattern, how those doctors are kind of using your technology? Just wondering kind of what the early learnings are there.

Speaker 2

Yeah. As we've stated, this is not us calling on all primary care physicians, right? We're leveraging that referral network and claims data that indicates where the majority of those patients reside. So, those practices know that they've got an abundance of patients. They know they've got a problem.

Speaker 2

And the challenge really is in identifying who they refer on and who they don't. Additionally, we referenced this last year, we started getting pushed by many of our pulmonologists stating, Hey, we really want to see our referral networks ordering your tests sooner. That helps them determine who they refer on. We've also and it's early but we've also seen some anticipate that they're going to see a stage shift. And so, they think that by pushing it further upstream, we're going to get to some of these patients earlier in detecting and diagnosing cancer.

Speaker 2

So, we're seeing some of that occur. It is early, but we are seeing that progress. But this really just revolves around pulmonologists supporting us working backward into their referral network so that when a patient is referred on to them, they've increased the likelihood that they've identified the right patient to be referred on. So, pulmonologists and primary care physicians are receiving it well thus far.

Speaker 5

And maybe a final one, just maybe to Robin. Just on the drawdown on the $10,000,000 EBITDA positivity by 4Q, just what's the latest update on kind of capital needs now with the $10,000,000 and how we think about the burn as we kind of move into '26 and kind of the available cash you'll have?

Speaker 4

We are as you mentioned, we're working hard on catching up our sales organization. And so, on the revenue side, we're about a quarter behind, we maintained our low operating expense, and sales and marketing was actually a little bit down year over year And so, the combination of the anticipated sales growth, the number of sales reps, and that tight control on OpEx, we feel confident about achieving adjusted EBITDA in the fourth quarter, just as we had stated before. The additional 10,000,000 gives us more confidence. We have more cash on the balance sheet, gives us a little bit more flexibility, and we continue to believe that this is sufficient capital to get us through to breakeven.

Speaker 4

That includes our commercial expansion, as well as the pipeline activities we discussed in the call earlier.

Speaker 5

Great. Thanks a lot. Thanks for the questions. I'll get back in the Thanks, Dan.

Operator

Thank you. One moment for our next question. Our next question will be coming from Andrew Braxton of William Blair. Maybe

Speaker 6

just to follow-up on Dan's question on sort

Speaker 1

of the changes to the sales force here.

Speaker 6

Can you maybe just give us a little bit more color on the specific changes for reps just in terms of who they call on, the resources that they have and just the broader incentives at play? Basically, what I'm trying to get at is how does this sort of change their day to day? Thanks.

Speaker 2

Yes. Thanks, Andrew. So from a pulmonology sales consultant, it doesn't change their day to day, right? They continue to call on pulmonologists, both those that are currently ordering and those that we're targeting. What's really new and different is within that pod or territory, having an associate sales consultant that will support them, spending a lot more of their time focused on accounts that are already ordering.

Speaker 2

So you kind of have the hunter farmer type scenario. This allows us to also build a bench. So our associate sales consultants are high potential. They're earlier in their career. And so we can build, them into transitioning from an associate into a pulmonology sales consultant.

Speaker 2

Also supporting within the pod will be the primary care focused sales reps. There's where the difference really is kind of the shift this year or the reconfiguration is going further upstream talking to primary care physicians within those referral networks. The associate sales consultant really is going to spend the majority of their time supporting the pulmonology sales consultant. Those regional sales directors and the area vice presidents really kind of manage all of the activities that they report up. But we're not going to ask the pulmonology sales consultants to shift their focus.

Speaker 2

They've built a network. We still have considerable room to continue to grow within pulmonology. We just knew that when we looked at the addressable market, that nearly fifty percent of the patients with a lung nodule are not making it to pulmonology. And so this is really about us continuing to increase the addressable market size and our access to it. Is that helpful, Andrew?

Speaker 6

It's very helpful color. Thanks for that, Scott. And then just as I sort of think about this reconfiguration, it would seem like there's a great opportunity for you within IDN. So can you maybe just talk about in the pilot, were there any IDNs included in that? And how would this configuration sort of help in effort?

Speaker 2

Yes. There wasn't specifically. What we really attempted to do was look at as many different scenarios as possible. So we didn't take kind of a tops down approach. We looked at it and said, Hey, let's call on general practitioners that have an integrated practice that's part of an academic institution in an urban area.

Speaker 2

And then the opposite extreme, let's call on a community based, more rural scenario. So as part of the pilot, we tried to vet all of those different scenarios to see how not only is our sales consultant received, but do they know? Are they aware that they have nodules, that they're sitting there? Are they spending time with those patients? Do they know who to refer on to?

Speaker 2

And ultimately, to ensure that we could be a success. What we learned is that we can. We think there's a greater opportunity with IDNs, but that was not really something we started with. We started more from a bottoms up, trying to ensure additionally that primary care physicians had the ability to order diagnostic tests, had access to phlebotomy services on-site. And what we found was they do, more so than the pulmonologist.

Speaker 2

They've got an awareness, they've got access and capabilities within sites. So logically, we think that they can be just as, if not more efficient and effective.

Speaker 6

That's helpful. And then just last one for me. I think you said ending the year right around 95 reps. Is that the number that we should of peg as we look forward over the next few years? Or does that expand beyond 95?

Speaker 2

Yes. We want to end this year at 95, and we plan on returning back to hiring approximately six on a quarterly basis in 2026. That'll get us right around 120 sales professionals by the end of twenty twenty six. We still feel that there's additional room to grow. We'll continue to assess our progress.

Speaker 2

The big question we have and we still have to learn here is how rapidly can we grow within that primary care space and do we need to continue to add there disproportionately. And we'll keep you guys updated on those learnings.

Operator

And our next question will be coming from Sung Ji Nam of Scotiabank. Just

Speaker 7

to follow-up on Dan and Andrew's question around your sales force filled out for the rest of the year. So it sounds like based on what's going on that the majority of the hire will be coming from the for the primary care market. And it also sounds like it might take longer for the primary reps to be trained or to to ramp up than your pulmonary focused reps. So is that is that the right way to think about it? And then just kind of what gives you confidence that you could be more efficient going forward for the rest of the year?

Speaker 7

Is this something that could take a quarter or two for you to really kind of get to where you need to be? Thank you.

Speaker 2

Hi, Sung Ji. Great questions. Yeah, you know, what gave us confidence was really vetting all of those scenarios. And so, some of the first questions we had to address and answer were, are primary care physicians even aware that this patient population resides in their care? And they were.

Speaker 2

It was a known problem and a known challenge. Secondarily was, well, if we're going to introduce blood based testing, do they have access and comfort around phlebotomy services? And they do. They either offer the services within clinic or they offer them on-site. What we've seen is that you increase the likelihood of a patient being compliant if you can conduct that blood draw on-site the day that they have the visit.

Speaker 2

And then also helping them understand the referral needs and the patterns within their community. And so, what they want to do from a primary care physician perspective is they want to refer on those patients with the highest likelihood of a malignancy, right, trying to get to early detection and diagnosis, which hopefully leads to a positive outcome. What they don't want to do is refer on patients with a benign nodule, right? Those are the patients that they can continue to monitor through CT surveillance on an annual basis. And so, real question for us was, do they see the value of the clinical offering?

Speaker 2

And they did. And so, we have had no issues or pushback there. When it comes to RAMP, what we saw during the pilot was very consistent with what we had seen thus far with our pulmonology focus. So, right now, we believe that they can be equally as efficient. The sales training program is slightly different.

Speaker 2

We've modified some of the materials to be more appropriate to a primary care physician's focus and awareness, but the training program is not longer or any more detailed. So, we look at this and think that their effectiveness and efficiencies should be realized very similarly to how we've modeled pulmonology sales consultants, but we'll continue to vet that and provide updates. But as we've modeled it, it is very, very consistent.

Speaker 7

Okay. Got you. Thank you so much for that. And then just my follow-up is on, know, it's great to see continued strength for your development services business and the pipeline there. Just curious, given everything going on with pharma, you know, around potential sectoral tariffs to the most favored nation pricing and whatnot.

Speaker 7

Just wondering if you're seeing any impact. I know it's still a small part of your business currently. If you're seeing any impact a dynamic environment, kind of how are you positioned in terms of that business? And Robin, also, you give us a sense of what percent of your guidance would be coming from Development Services? Thank you.

Speaker 2

That's a great question. We continue to monitor things just as everybody else, and we've all seen things are changing quite rapidly. I'm happy to report and share that thus far, we don't see any impacts directly from a tariff perspective, favored nations perspective. Our biopharmaceutical partners have been very transparent with us, especially those that we already have a contract in place, But we're continuing to monitor it. So, more recently at AACR and then here as we head to ASCO here in a couple weeks, we'll continue to have that dialogue, making certain that we stay abreast of all of the challenges that they might be facing and how it can impact us.

Speaker 2

The good news is many of our studies are based upon retrospective samples, so in those cases, it's really about access to those patient samples. I think the bigger question will be prospective trials, And if a pharmaceutical company continues to prioritize and invest in that trial, if they do, then we should be in a good position. If they don't, obviously that could be of impact to us. And as we think more broadly, we're proud of the $10,900,000 in dollars under contract but not yet recognized. Our request for proposal and outreach has continued to increase and is at an all time high.

Speaker 2

So, you know, the offering that we're providing, our rapid turnaround time and those insights in our team, seems to be resonating with our biopharmaceutical partners. And going forward, we've consistently seen our total revenue from a biopharma services perspective being about 10% of total revenue, and we expect it to remain consistent.

Speaker 7

Got you. Thank you so much.

Speaker 6

Thanks, Sanjee.

Operator

Thank you. And our next question will be coming from Kyle Mixon of Canaccord Genuity. Your line is open.

Speaker 3

Thanks, guys, for the questions. Scott, at what point in during the quarter, I guess, or maybe recently did you kind of understand or figure out that like the sales force expansion situation was going to cause a reduction to the revenue potential for the year? And just like kind of curious when you do this going forward, how you can kind of work on visibility and communicate and things like that? Just any color on that would be interesting.

Speaker 2

Yeah, thanks, Kyle. You know, as we've reminded others, as a first mover in lung management and lung cancer, having the only diagnostic focused team, we're learning constantly. We don't have any predecessors out there, so we try to apply those learnings as quick as possible, update our plans and our forecast as soon as we're able to do so. As we entered this year, early in the first quarter, we made the decision to continue to explore more about the primary care physicians. And as we progressed and saw the successes and committed to it, we really started our hiring efforts.

Speaker 2

Some of those initial learnings that I talked about, whether it's a slightly different background, a different skill set, and also familiarizing them with us, with the Biodesics team, that took a little bit longer than we had thought, but it was quite fluid. It wasn't like overnight. It was a continual process over a three to four to five week period that we were revisiting it daily, continuing to focus. Additionally, when we stated that we made the shift to territories in the pod structure, we did shift some territories and it caused some difficult conversations with sales team members on changing of territory where some gonna move. So we did have some opt out.

Speaker 2

And so when we state that it was quite fluid as much as we were trying to add, we did have some turnover that was slightly more than we had anticipated or liked. We never liked to lose any team members. But we feel that as a learning organization, the goal really is about making progress. If you're going to fail, fail fast. Apply those learnings.

Speaker 2

We still feel very confident that we've got a great strategic plan. We continue to execute and we continue to grow. All the while, and most importantly, we're gonna get to profitability. And as you know, there's very few diagnostic companies that have ever done it and those that have, haven't stayed. And so, we think that what we're doing is durable, and we're excited to continue to build that out.

Speaker 3

That's great. And then when you think about the target to achieve adjusted EBITDA breakeven by the fourth quarter and you reiterated that, which is great. Just given this top line decrease here, mean, levers do you have to pull that will help you get to that target just in case the top line remains soft as the primary care team continues to ramp?

Speaker 4

Yeah, obviously revenue plays an important factor in reaching adjusted EBITDA breakeven, but we do have some levers on cost. We get asked a lot, could you grow faster? And the answer always is, yes, we could, but our focus really is getting to breakeven. So, it's a balance of adding these sales reps quickly to catch up, so that we can get our revenue in the fourth quarter where we need it to be to hit adjusted EBITDA, but also balancing that spend on the commercial expansion. So, it's really both.

Speaker 4

It's getting these reps in, trained, and out in the field as quickly as we can to catch up, and then also being very closely monitoring and managing our expenses.

Speaker 3

Awesome. And then just from a product perspective, could you guys dive into the treatment guidance side of the business and talk about which of the tests there are performing well and especially curious how Genestra NGS has done the past couple of years more recently, I guess.

Speaker 2

Yes, to remind others on the call, our IQ lung franchise is really our treatment guidance portion of the product portfolio where we have three tests. We have two genomic tests: Genistrat, which is a DDPCR based test and we have a broader panel, Genistrat NGS test, which is a fifty two gene NGS panel And then we have our Baristrat test, which is a proprietary test where we measure and monitor a patient's immune status. Baristrat really is the key driver in that portfolio, where there's no competition to date. And you've you've heard us over the last few earnings calls start to talk about the development efforts that we continue to pursue and invest in on the Verastrat front. So it is the most valuable as we think of future state and and uniquely being positioned as a proteomic test.

Speaker 2

It's one of the things that differentiates us as having three on market proteomic tests, unlike anybody else out there. On the on the second part of your question, know, NGS is an exceptionally crowded space. We're not out with our sales professionals selling to medical oncologists for all cancers, so it puts us at a disadvantage in capturing the broader NGS market. As a reminder, we're really focused on helping pulmonologists detect and diagnose cancer early, and then help order and facilitate ordering of that NGS test so that when a patient is referred on to a medical oncologist, he or she has those test results in hand. So they're modest contributors, but we still feel that they're extremely strategic and valuable to the overall offering.

Speaker 2

And as we continue to invest in the pipeline, you may have noticed that many of those tests fit more into that treatment guidance side of the business. So as we progress through the year and head into 2026, we'll provide greater clarity as to what that means for continued evolution of the sales force.

Speaker 3

Perfect. And then last one before I hop off on MRD. You you gave a little more color on that one today. I know you have the R and D Day in the fall, I think. Just Yeah.

Speaker 3

Maybe could you just touch on how you might commercialize that test? And, you know, just given your current sales force, isn't adequately suited to target that end market properly, like how would you sort of think about building out that team over time?

Speaker 2

Yeah, it's a great question. And really to reiterate, first and foremost, our top priority when it comes to the commercial team is Notify. With a first mover advantage in lung nodule management, we've got to continue to focus all of our time and attention there. And as Robin said, it's where we get the greatest return, and it's what will drive us and fuel us to to break even. As we continue to make progress, we've had tons of experience and learnings over the years, you know, starting back when Verastrat was the first test and we called directly on medical oncologists.

Speaker 2

So we know what that takes. We know how to position and present those products, but we're gonna do that in kind of a phased approach and be very mindful and intentional about not distracting from Notify. You won't see or hear anything in 2025 on the commercial front. The goal that we've stated earlier on the call was to have an MRD offering for biopharmaceutical research interest by the end of this year. The longer term play is gonna be more in the latter half of twenty six going into 2027.

Speaker 2

We wanna be mindful that anything we introduce, we've gotta have a reimbursement plan. We've gotta make sure that we've got payers on board because once we get to profitability, we plan on staying there.

Speaker 3

Got it. Helpful, Scott. Thank you.

Speaker 2

Yeah. Thank you, Kyle.

Operator

And one moment for our next question, which will be coming from Thomas Flaten of Lake Street Capital Markets. Your line is open.

Speaker 8

Yes. Hey, thanks for taking the questions. Scott, just doing some back and envelope math. If you get to about 100 at the end of this year, there won't be a one for one pulmonologist with a junior PCP rep. So you're obviously making decision that certain territories should have a PCP rep versus others.

Speaker 8

Can you just walk us one, is that correct? And then if so, could you walk us through the thinking behind that?

Speaker 2

Yes. Just to clarify, it will be a one to one for the pulmonology sales consultants. So all 50 territories will have a pulmonology sales consultant. They won't all have an associate sales consultant or support. Yeah.

Speaker 2

So as they start, you really think about it. They go out and start to build the business. They gain momentum. Then as they get a customer up and ordering, we really want the associate sales consultant to come in to support that business to help those ordering accounts increase effectiveness and efficiency, freeing the pulmonology sales consultant to continue to go out there and target and bring on new ordering accounts. We really do assess those decisions on a one by one basis, and it's a factor of test volumes, number of accounts.

Speaker 2

In some territories, it also has to deal with geographic size. We really are trying to ensure that we can increase access all the while being as present as needed. Same thing with the primary care sales professionals. As we bring them on board, you're not going to have 50 of them. We know through claims data that we've pulled and from conversations with our pulmonology ordering physicians and mapping back those referral networks, we know which primary care physicians are, as we stated, out of those broader 250,000 primary care physicians, narrowing it down to the 15,000 that account for eighty percent of the lung nodules.

Speaker 2

So we know who they are and it's very targeted. So, again, not all territories are created equal on all fronts, and so we'll continue to invest in the primary care sales professionals first and foremost in the territories where we have established relationships and can support that transition and pull into the referral network. Is that helpful, Thomas?

Speaker 8

Yeah. No. That that that's great. Thank you for that color. And then I'm just trying to understand a little bit the the the sequential downdraft in in testing volume and the promotional sensitivity of these docs to having reps around.

Speaker 8

So you didn't expand, you contracted a little bit the number of reps sequentially and volumes were down. Is that just because there wasn't a rep there kind of reminding them all like on an ongoing basis to order the test? I'm trying to understand why a few weeks of a missing rep would have a significant impact on volumes sequentially.

Speaker 2

Yes, it's a great question. Over the last five years, we have seen a sequential decline Q1 compared to Q4. So, that wasn't a surprise. There's a number of contributing factors that come into play there. So, we anticipated that whether it's weather, some seasonality, respiratory, those things have been consistent over a four to five year period.

Speaker 2

It's in flux as to how significant the impact may be. But we definitely did, as we were moving around the territories and decreased the size, we did see stretching the organization to ensure that we could call on and support all of those ordering physicians. But where you really see it is in the absence of a sales professional, you're not gonna continue to grow and bring on new accounts. That's the biggest challenge that you face. And so as we we track once we bring an account on and that physician begins ordering, obviously we want to see them continue to increase the number of orders.

Speaker 2

We want to see their partners within a practice start ordering so that we can expand within practice. And that takes time. But the one thing that you can't do if you don't have somebody present is you can't go out there and onboard a new ordering account. So we definitely saw an impact there. It's what gives us confidence is because we've seen a continued consistent sales rep productivity quarter over quarter.

Speaker 2

And so we know that when we have sales professionals in the territory aligned working within that pod structure, that it sets us up for success. Great. I appreciate it. Thank you. Thanks, Thomas.

Operator

Thank you. And our next question will be coming from Bill Bonello of Craig Hallum. Your line is open, Bill.

Speaker 9

Hey, guys. Thanks a lot. So a few things. I guess just starting with the number of reps, either the decline from 70 to 65. Obviously, you said in answering Kyle's question, had some attrition, maybe some attrition you didn't didn't want to have.

Speaker 9

But, I mean, how do we how do we think about that if you, you know, if you reduce the number of territories to 50 territories, I I don't know if you had more than 50 pulmonologist reps in that group of 70, if it was sort of inevitable that some were gonna have to to go? And if you can give us any sense of the maybe the attrition, you know, whether, you know, we think of it as maybe you lost five or so, or or did you hire some too and and you lost more productive reps than that?

Speaker 2

Yeah, it's a great question, Bill. You're spot on, right? When we exited last year, because we were focused on just calling on the pulmonology sales consultant, you definitely have that attrition as we've stated. We went down to 50 pulmonology focused sales consultants. You also there's a a ripple effect there with the associate sales consultant because they they both support each other in calling on the pulmonologist.

Speaker 2

On on the pulmonology sales consultant side, it is what you what you've described. If we're gonna constrict there down to the 50 territories, there definitely were some that that that need that weren't gonna fit, if you will. On the associate sales consultant side, it's a little bit different of a challenge because these are earlier career professionals that we have confidence in and their high potential. So when a territory opens up, they're the first individuals that we want to provide an opportunity to promote them in. So in constricting and changing, some of those associate sales consultants now didn't see their timeline for promotion was the same as they desired, and so they opt out.

Speaker 2

And so we look at it and say, it's it's a good blend and mix across the the both, you know, areas. There's nothing really telling or anything concerning in there. You never like to make these changes, and we never like to lose teammates. But as we've continued to progress here with the primary care sales consultants, we're really seeing a lot of success. So for us, you know, wasn't the ideal timing needed to be done, and so we tried to do it as fast as possible to minimize the impact and shift focus so that we can move on to really the fifty percent of patients that are stuck in primary care.

Speaker 2

Opening that addressable market up and gaining access to those patients is critical for us.

Speaker 9

And I guess just understanding that a little bit more, mean, was that the notion of going I mean, obviously, there's a direct correlation between the number of salespeople you have and the amount of revenue and volume that you're going to generate. And so was the notion that, gosh, the only way we really can expand this associate model and hire some PCP reps, which we think will be productive, is if we cut back on the number of territories. We just can't afford to add associates and PCP reps and keep the number of pulmonology reps we had? Or what was sort of the basic thinking behind reducing the number of territories?

Speaker 2

Yeah, you know, Rodden stated it, our number one goal is to get to break even. And so we kept that in mind. If our number one goal was to grow, we would hire, but we know that it would cause an initial spend and there would be a time before those individuals could contribute. So, it really was balancing the two efforts, ensuring that we could be one of the few diagnostic companies that can get there and that when we got there, was sustainable. But also, really trying to apply all of our learnings as we've stated.

Speaker 2

We're going to continually learn here. We think this approach we've been anticipating that we might have to shift to this. And the pulmonologists that have gotten to know us well, when they started encouraging us to do this, we saw that as the opportunity to lean in, and we did. And it's been received well, we continue to see great success. So, you know, two, three years from now, we'll take those learnings.

Speaker 2

We might have 52 territories. Right? The territory component will allow our successes and our learnings to guide us there. We aren't really wed to one, one scenario. Is that helpful, Bill?

Speaker 9

Yeah, that's helpful. And then just one final question, because I know we're bumping up against the hour here. Just strategically, would you consider partnerships for primary care? I know you talked about maybe a focus group of PCPs that you're trying to reach, but 15,000 is still a lot of people and there obviously are labs out there with well developed primary care sales forces and patient service centers and in office phlebotomists and what have you. How did you kind of think through the decision of doing that expansion on your own versus maybe just partnering with somebody that leverage their existing primary care network?

Speaker 2

Yeah, it's a great question. And we spent a lot of time considering that. I think as walk you through it, on it was don't make any assumptions, let's do the pilot and learn. And so, what the pilot really demonstrated is that there's a great opportunity within primary care than do we do it ourselves or do we partner? Because we're starting small and because of the progress we've made, we chose to go at it ourselves.

Speaker 2

But we have considered and discussed what it might look like to partner with others, and we're open to that. So, we'll continue to assess it as we move forward. But really, when you think about the size of that market, 15,000 primary care physicians account for eighty percent of those lung nodules. There's about 14,000 pulmonologist. So, you know, we looked at it and said, hey, we know that's manageable.

Speaker 2

We know who they are. We've got them mapped. We can target to them. I think as we continue to make progress, you know, we'll welcome those conversations. But I think the other thing was is we didn't see an ideal partner out there that would give us the time and attention that we're going to.

Speaker 2

And we owe that to our pulmonology customers and their patients that are fighting lung cancer.

Speaker 9

Sure. Okay. Thanks a lot.

Speaker 2

Thank you, Bill.

Operator

And I'm showing no further questions. I would now like to hand the call back to Scott Hutton for closing remarks.

Speaker 2

Thank you. In closing, I want to express my gratitude to all the remarkable members of the Biodesics team who have 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 through our healthcare provider customers and industry partners. I am truly thankful for your efforts. I also want to take a moment and say thank you to Doctor.

Speaker 2

Chuck Watts and Jack Schuler, both of whom have been long standing board members at Bioethics, providing invaluable insights and guidance to the company for many years. While Chuck is retiring with our sincere appreciation, Jack will be moving into a board emeritus role and will still be participating and contributing to board activities for the foreseeable future. Thank you.

Operator

And thank you for your participation in today's conference. This does conclude the program. You may all disconnect. Thank you.

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Key Takeaways

  • Biodesix grew Q1 revenue by 21% year-over-year to $18 million, improved gross margin by 80 bps to 79.4%, controlled SG&A spend and narrowed its adjusted EBITDA loss, targeting positive adjusted EBITDA in Q4 2025.
  • The company reconfigured its sales force into 49 territory “pods” with senior pulmonology reps, associate reps and newly recruited primary care reps, trimming headcount from 71 to 65 in Q1, but plans to hire 10 reps per quarter to reach ~95 by Q4 and revised 2025 revenue guidance to $80–85 million.
  • Biodesix expanded its logistical and digital infrastructure for lung nodule diagnostics by launching a nationwide mobile phlebotomy network and Tasso capillary device (boosting on-site draws by 30%), and enhanced EMR integrations that drove a 58% increase in digital orders with 40% higher customer retention.
  • Pipeline progress includes a combined genomic + proteomic MRD test for biopharma development services by end-2025 and new data on its Veristrat immune classifier in prostate cancer and immunotherapy settings, replacing the prior primary immune response test.
  • Development services revenue rose 61% year-over-year to $1.7 million in Q1, with a $10.9 million contract backlog (+21%), driven by its multimodal genomics, proteomics and radiomics expertise for biopharma and diagnostic partners.
AI Generated. May Contain Errors.
Earnings Conference Call
Biodesix Q1 2025
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