Biodesix, Inc.

Welcome to the Biodysic Q1 2024 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Chris Brinze, Investor Relations.

Please go ahead. Thank you, Operator, and good afternoon, everyone.

Thank you for joining us today for a discussion of Biodesic's first quarter 2024 business highlights and financial results. Leading the call today will be Scott Hutton, Chief Executive Officer. He will be joined by Robin Harper-Cowie, Chief Financial Officer. After the prepared remarks, we will open the call for Q&A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. Today, we issued a press release announcing our business highlights and financial results for the first quarter of 2024. A copy of the release can be found on the investor relations page of the company website. Actual events or results may differ materially from those projected as a result of changing market trends, reduced demand, and the competitive nature of the diagnostics industry. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. The forward-looking statements discussed on this call are subject to other risks and uncertainties including those discussed in the Risk Factors section and elsewhere in the company's annual report on Form 10-K for the year ending December 31, 2023, filed with the Securities and Exchange Commission, as well as subsequent quarterly reports on Form 10-Q, filed during 2024, as applicable. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company's press release, issued today and in the company's filings with the SEC. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. A reconciliation to the most directly comparable GAAP financial measure is available in the press release we issued today. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

Thank you, Chris. and thank you all for joining us today. It's been a great start to the year, and I'm thrilled with our performance in the first quarter. Our organization and all team members remain committed towards delivering upon the three goals we outlined last quarter. These include driving increased revenue through the adoption of our lung diagnostic test and our biopharmaceutical and diagnostic services, implementing operational efficiencies to improve gross margins, and maintaining a cost-disciplined approach on our path to profitability. Achieving these three goals is all about successful execution of our business plan, and I believe our first quarter results highlight the commitment of our team to making this happen, and we are on track to meet and exceed our goals for the year. I'm pleased to share that total revenue grew 64%, driven by our seventh consecutive quarter of greater than 50% growth in lung diagnostic test volumes. and over 100% growth in our biopharmaceutical services revenue. Gross margins were 79%, which continues to rank among the highest in the diagnostic industry. On top of that, we improved our adjusted EBITDA by 48%, making yet more progress on our path to profitability. Our pulmonology-focused sales team is comprised of sales consultants managing territories and associate sales consultants who focus on developing additional business and existing accounts in those territories. After a positive pilot program, we started building out the associate sales consultant team in 2023. In the first quarter, we had an average of approximately 55 fully trained sales representatives, including both the territory managers and associates, and started the second quarter with approximately 60. Today, this model has been implemented in more than 50% of our sales territories, and we plan to continue strategically expanding through the remainder of the year by adding about six to eight additional sales representatives and associates per quarter. Overall, this model has proven to be very effective in strengthening account retention and expanding within an account by adding physician users. It also creates a successful, fully vetted, and fully trained bench to backfill territories as needed and rapidly expand into new territories to drive further growth. In our biopharmaceutical services business, we continue to see the momentum that began in the second half of last year. Like our lung diagnostic testing, we're achieving growth through additional projects from existing customers, as well as new contracts from new customers from an increasing number of incoming RFPs and opportunities. In addition to the lung diagnostic and biopharmaceutical service advancements made in the quarter, we were thrilled to announce our new co-development agreement with Memorial Sloan Kettering Cancer Center. This expands on our earlier research collaborations and will accelerate the development of new diagnostic tests aimed at improving cancer treatment options and outcomes. Our Chief Development Officer, Dr. Gary Pisano, and Dr. Howard Scheer from MSK shared an update on this new collaboration at the 31st International Precision Medicine Tricon Meeting. The framework presented demonstrates our pipeline strategy that builds on our strength in product development, quality, reimbursement, and commercialization, and gained strength from selectively partnering with premier clinical institutions, such as MSK, and also with other strategic partners in the technology and regulatory space. Building on our existing body of clinical data, a new manuscript in which our liquid biopsy DDPCR testing was an important component was published in collaboration with the Friends of Cancer Research, and we shared a number of presentations at the American Association for Cancer Research annual meeting. The AACR data demonstrated are advancements in liquid biopsy testing, including the real-world value of actionable variant testing in the community, as well as informing clinicians with actionable information to make rapid and optimal treatment decisions. We also continue to enroll in altitude. our prospective randomized trial evaluating the clinical utility and performance of our notified testing that's been conducted at a number of major academic institutions. This study is being overseen by a third party independent data monitoring committee that will be determining updates on potential interim analysis and will provide more updates in the coming quarters. Finally, moving to operations Our team continues to deliver on test process automation and workflow optimization projects covering commercial diagnostics and biopharmaceutical services that continue to drive improvements in gross margin. We ended the first quarter with 79% gross margins, an increase of 14 points over last year, and another two-point enhancement over an already strong fourth quarter. We've been exceptionally effective in providing our tests with industry-leading turnaround times and have made great strides in becoming even more efficient in the delivery of those tests. With our commitment to an effective, efficient, and cost-disciplined approach, we've built a commercial and operational platform that will help facilitate long-term, consistent, sustainable growth. And I believe everyone is beginning to appreciate the operating leverage that exists within the business model and our efforts to demonstrate the team's significant progress and outstanding execution on our path to profitability. Before I turn the call over to Robin, I'd like to reiterate our commitment to transform the standard of care in lung cancer and improve patient outcomes with personalized diagnostics. Lung cancer is still the deadliest of all cancers, as it claims more lives annually in the United States than the combined total of the next three deadliest cancers, breast, prostate, and colon cancer. Time is of the essence when it comes to diagnosing and treating these patients. By discovering, developing, and commercializing tests with demonstrated clinical utility and best-in-class turnaround times, we believe that our diagnostic tests play a critical role in these efforts to treat the right patients quickly and effectively. With that, let me turn it over to Robin to review the first quarter 2024 financial performance. Robin?

Thanks, Scott. First quarter total revenue was $14.8 million, a 64% increase over the prior year. We delivered approximately 11,900 lung diagnostic test results in the first quarter of 2024 versus approximately 7,600 test results for the first quarter of 2023, a 57% increase. Lung diagnostic revenue in the first quarter was 13.8 million compared to 8.6 million for the first quarter of 2023, an increase of 60% over the prior year. This was driven by continued strength in testing volume growth despite continued challenges with certain Medicare Advantage plans. As we've discussed in prior earnings calls, we continue to experience delay in some Medicare Advantage payments for our Medicare covered tests from certain payers. While we continue to work with the plans to resolve the administrative hurdles, the backlog of claims continues and is now approximately 3.5 to 4 million. We will continue to provide updates in our calls as we work towards a satisfactory resolution And as a reminder, we have excluded both the collections of any of the backlog and the prospective collections from tests from these payers from our guidance in 2024 as we work to resolve the administrative issue. Biopharmaceutical services revenue was $1.0 million in the quarter compared to $400,000 in the first quarter of 2023, an increase of 149%. Importantly, We continue to see continued strength in the number of incoming requests in this area of our business, and we ended the quarter with $9.0 million contracted but not yet recognized as revenue. Gross margin percentage in the first quarter of 2024 increased to 79%, up 14 percentage points versus 65% in the prior year quarter, and 77% in the fourth quarter of 2023. The steady improvement we have seen And the current gross margin trend reflects the growth in our lung diagnostic testing and the successful completion of projects to decrease costs and optimize testing workflows. As we've made such large improvements over the last year, we anticipate that the margins will remain fairly steady in the mid to upper 70s going forward. Overall operating expense, excluding direct costs and expenses, was $22.7 million in the first quarter of 2024, compared to $22.3 million for the same period of 2023. only 2% growth versus 64% growth in revenue, demonstrating the operating leverage that exists within the business model. The increase in operating expense versus the prior year quarter is primarily the result of an increase in non-cash stock-based compensation and depreciation expense related to the leasehold improvements in our new Louisville, Colorado office and laboratory, plus increased sales and marketing costs to support lung diagnostic sales growth to enhance product awareness and drive adoption, partially offset by a decrease in research and development costs. Specifically, operating expense for the first quarter 2024 includes $4.1 million in non-cash stock compensation expense, non-cash depreciation and amortization, and asset impairment as compared to $3.1 million during the comparable period in 2023 and $2.1 million in the fourth quarter of 2023. Net loss for the first quarter of 2024 was $13.6 million compared to $18.7 million net loss for the same period of 2023 and $9.1 million for the fourth quarter of 2023. The decrease in net loss for the quarter was driven primarily by the increase in revenue, improvements in gross margin, and reduction in certain operating expenses, including R&D expenses. The increase in net loss versus the fourth quarter reflects an increase in the depreciation expense related to the leasehold improvements in our new Louisville, Colorado office and laboratory and non-cash stock compensation. To provide better clarity of progress on our path to profitability, during the third quarter of last year, we started reporting adjusted EBITDA, which excludes certain non-cash items and COVID-19 testing revenue and direct costs and expenses. Adjusted EBITDA for the first quarter, 2024, was a loss of $6.96 million compared to a loss of $13.32 million for the first quarter 2023, a 48% improvement. The improvement in adjusted EBITDA in the quarter demonstrates our focus on actively managing our operating expenses, our success in improving gross margins, and driving growth in top line revenue, resulting in a decrease to our cash burn. While we ended the quarter with $11.5 million in unrestricted cash and cash equivalents as compared to $26.3 million at the end of the fourth quarter, I did want to highlight important subsequent events that have strengthened our balance sheet, putting us in a well-capitalized position for continued growth going forward. In April, we announced the closing of $55 million in gross proceeds raised in our successful oversubscribed and upsized underwritten offering and concurrent private placement. This fundraise strengthens our balance sheet, expanded our investor base, and provides us the runway to accomplish our goals of growing the top line and achieving profitability. After taking into consideration underwriting fees and commissions, the company collectively raised net proceeds from the equity offerings of approximately $51.5 million. Subsequent to the end of the quarter on April 1st, the company made the scheduled milestone payment of $5.3 million for the acquisition of integrated diagnostics in 2018. In addition, we prepaid the July 1, 2024 milestone payment of $8.4 million, which included interest through the date of payment, saving approximately $160,000 in interest. The company has one payment of $6.1 million remaining due on October 1, which does not accrue interest. Finally, turning to 2024 guidance, We are reiterating our plan to deliver 65 to 68 million in total revenue and are excited to deliver on our year of execution. Now let me turn it back to Scott.

Thanks, Robin. It's been a great start to the year, and we've delivered our seventh straight quarter of greater than 50% growth in lung diagnostic testing volume, over 100% growth in biopharma services revenue, 79% growth margins, and substantial progress on our path to achieving profitability. And with the additional capital in place to support our long-term growth, I believe our future is brighter now than at any point in the company history. We remain committed to executing upon our three goals, driving increased revenue by accelerating the adoption of our lung diagnostic test and biopharmaceutical services, implementing operational efficiencies to improve gross margins, and maintaining a strict cost discipline to achieve profitability. By aligning these three strategic efforts, we are confident in our ability to sustain our aggressive growth trajectory, make progress on our path to profitability, and deliver value to the healthcare professionals, their patients, and all shareholders. We are transforming the standard of care and are excited to be making such a significant impact. With that, I'll turn the call over to the operator for questions.

Thank you. At this time, we'll conduct a question and answer session. As a reminder, to ask a question, you need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Brackman from William Blair. Please go ahead.

Hi, Scott. Hi, Robin. Good afternoon. Thanks for taking the question. Maybe just starting here on the rep side of things, you maybe just sort of talk to us about rep productivity by cohort. You've added a handful. You've really added a significant number of reps over the last handful of years. So just any color that you can provide and what you're seeing from these different groups from those hiring classes and how that plays into your confidence and volume ramp for the rest of the year. Thanks.

Yeah, thank you, Andrew. Appreciate the question. Yeah, we have continued to kind of maintain a six to eight sales professionals being added per quarter. We've continued to maintain about a three-month timeframe from a new hire getting to a position where they're paying for themselves. So that gives us confidence that what we're doing is working in terms of training and onboarding. Now, when you look at the United States and where we have territories, we know that, especially in the West, we still have a number of territories that are too large. So when we place an individual in one of those territories, we know that that ramp might be a little bit lengthier, and those individuals are gonna have potentially a higher cost associated with their day-to-day activities. So they aren't all created equal, but because we are seeing that kind of path to profitability in their efforts be somewhat similar, it gives us confidence that we can continue to grow. We also are able to assess penetration and adoption within territories. And we know that we're just beginning to scratch the surface in this massive opportunity. So as we look at the full year, continuing to add six to eight sales professionals per quarter, we expect that we'll end the year somewhere around 70 to 72 that are contributing. The real key will be in that last cohort of how early do we bring them on and how much are they able to contribute probably into the second or third month of the quarter. So for us, we factored that in in our plans coming into the year, and we've guided really from a model and a position, or a framework I should say, that's built upon that sales rep productivity and that sales rep expansion. Now we have talked a lot about the associate sales consultant We've got, we're approaching 50% of our sales territory is actually having an associate sales consultant. That mix will change. It's going to be based upon productivity. It's going to be based upon size of territory and the real opportunity to continue to grow and expand. But we're grateful that we introduced that and piloted that a little over a year ago. And we see a lot of upside there remaining. Hope that was helpful, Andrew. Yes, very helpful.

Great color. Maybe I guess just sticking on the commercial infrastructure here for a minute, as you've established that channel in pulmonology, can you maybe just talk to us at a super high level on how you're thinking about further leveraging that channel moving forward, be that through new products that are organically developed or even partnerships or M&A? Thank you.

Yeah, great question. We feel that it's one of our strongest assets. All of us know that many efforts commercially don't succeed the first or second time. So we don't take that lightly. The fact that we've built a fully integrated commercial team and channel and having the successes that it's having, we know that there's greater opportunities. We also hear it from our pulmonology customers where they present new disease states or challenges and really they're all based upon a critical clinical question that remains unanswered. So we know there's additional opportunities just to provide value. We also know that there's a means by which we could potentially do so in an accretive fashion by adding additional products to our sales reps' bags and, you know, meanwhile, decreasing the size of their territory. Those are all on the roadmap and the horizon. You know, this has been an interesting year with our successes. We've had a number of companies reach out to talk to us about opportunities to sell their products, to distribute it, and we've said no. For us, it's laser-focused. We're so underpenetrated in this opportunity. We're focused, first and foremost, on really continuing to invest in this sales channel. And the reason I state that is, in the future, I still believe that this sales team can add two to three, maybe even four more products, as long as they're appropriate for that call point. And we're going to find a means by which we do that, whether that's organic or inorganic.

That's great. I appreciate the time today.

Thank you.

Thanks, Andrew.

Thank you. One moment for our next question. Our next question comes from Kyle Mixing from Conaccord Genuity. Please go ahead.

Hey, guys. Thanks for the questions. Congrats on the quarter. I guess on that note, you know, revenue numbers did beat by almost $1 million yesterday. cord lung and fly pharma have momentum and they're, you know, getting back on track, I guess, I guess, you know, why not raise the revenue guidance? I'm just kind of curious, like given that momentum and, you know, the field looks pretty open here. Is there anything to look out for in the lung diagnosis market in the near term that you see?

Yeah, thanks, Kyle. Great question. You know, for us on this journey, one of the things we focused on is really building trust. And we've been very consistent about the opportunity, very consistent about our priorities. And so as we focus on trust, you know, getting the 2024 year off to a great start, putting up a good quarter was our first priority. And I think we've done that, and I think you acknowledge that. We know once we've done it once, we want to do it twice. And so if anything, we're just being mindful of managing expectations. It's early in the year. I'm certain that we'll talk a little bit about the LDT FDA ruling. Some of those uncertainties just cause us to pause and, you know, quote, unquote, don't want to get over the tips of our skis. But we are very bullish on the year. We feel that we've got a lot of momentum. And I think you nailed it. The core lung diagnostic business continues to perform exceptionally well with our seventh consecutive quarter of greater than 50% growth. And we're really excited to see that rebound we've been talking about on the biopharma services. And so to put up another strong quarter there, have greater than $9 million of contracted business yet to be recognized on the biopharma services front, we feel really good about that. But on the biopharma services front, that's been the area that's been quite lumpy. Whenever you're dealing with partners or third parties, you've got to make certain that their priorities remain consistent and strong throughout the year. And most of those contracts are reliant on us receiving samples. And so we'll continue to talk a lot about the upside that we see. But for us, it's really let's just execute, let's put up strong performance, and let's have those conversations at the end of the second quarter.

That was great, Scott. Thanks so much. And on that note, the biopharma revenue, I guess the services side of things, you know, funding is definitely getting better. There's been, you know, IPOs, there's been private deals. So I'm wondering if, you know, this revenue contribution recently, what you're looking at in the near term, this $9 million in contracted revenue, is that like new RFPs or just the completion of new deals? Is that, of old deals, excuse me, is that going to be what the revenue kind of gets filled in by? And then what happens when the funding situation in the biotech world kind of levels out a bit? Could there be like a bolus situation of this biothermal revenue in the first quarter and second quarter maybe, or would there be kind of like growth throughout the year with a flush towards the year end possibly?

Yeah, that's a great question. You know, for us, as we've focused on, you know, building that trust and rapport with our partners, what we've seen is a lot of continuation and build on contracts. That's the ideal way to do it, where you partner with a partner, say, for an early stage discovery effort it works well, you move on to the second phase, you move on to the third, and those contracts become larger. But more importantly, you become of greater importance to that drug discovery and development effort. So we've seen a number of those that have continued. We have seen new RFPs come in from new partners, and we're proud to share that we've signed some of those agreements. We don't really attribute any of that to new fundraising efforts. I think those biopharmaceutical companies that have completed some of those fundraising efforts, you know, they're more on the horizon. They're going to be targets for us moving forward. And when it comes to revenue recognition and achievement, you know, it really is dependent upon the type of agreement that we sign and whatever their hypothesis is and what we're trying to help them answer the question to. You know, if it's retrospective samples, there's a likelihood that it can have a near-term impact. once we receive those banked samples. If it's a prospective trial or study, obviously those are a little bit easier to forecast, but those are going to be spread out over multiple years. So we look at that $9 million under contract, and the best way to look at that is we'll recognize the majority, if not all, of that revenue over the next two, maybe sliding a little bit into three years. So it gives you confidence that there's a good book of business that's built. It'll continue in a sustainable fashion for quarters to come. And then the sales team is out continuing to expand that funnel. So great opportunity. You highlighted the fundraising market for biopharmaceutical companies. One of the things we saw historically was a year-end push. We haven't seen that recently. So we'll keep you updated as we progress through this year. to see if we actually anticipate a significant hockey stick towards the end of the year. But at this point in time, it's too early to say. But we'll be well-positioned to capitalize if it presents.

Okay. That was great, Scott. Thanks a lot for that. And a final one for Robin. It's actually a two-part question. First is on the kind of like unpaid MA, the Medicare Advantage claims. I think it was $3.5 to $4.0 million. dollars in claims. I guess, you know, we've been hearing that for at least a few quarters now. Is there a possibility that you lose the opportunity to recognize that revenue after a certain period of time? Or is there just, you know, you have some unspecified amount of time to capture that and therefore you're probably good to go, you know, even if it takes years to capture. That's the first part. Second one's on the $6 million payment. I think it was, I think it's going to be paid in October. How was that structured? Is that just like a standard in your OpEx or something? And it's like, like baked in there or is it like incremental almost like they like kind of spaced out a bit?

Yeah. Hi, Kyle. The Medicare Advantage, because we didn't recognize that revenue as an accrual in the period that the tests were performed, it will be recognized upon cash collections. So there's no clock for our ability to recognize it. When the cash comes in, that's when we'll recognize it. We're in good shape there, and we'll keep you all updated as we make progress. No interaction or transaction with a payer is fast, and so yes, it feels like a lot of quarters that we've been talking about this, which can be frustrating, but it's sort of the nature of the beast. The $6 million to be paid in October is just the last payment of the milestone payments for Indy. So we had it set up that we were paying quarterly over the span of multiple years on those milestones. And all but the last milestone carried interest. Following our fundraise in April, we actually prepaid the July 1st payment, which saved us about $160,000 in cash. So that's cash that stays in the business and doesn't leave. We did not prepay the October 1st milestone because there is no interest. So there's no real incentive for us to move it forward.

Perfect. Okay, thanks for clarifying all that. Thanks, guys. Appreciate it.

Thanks, Kyle.

Thank you. One moment for our next question. Our next question comes from Thomas Flatton from Lake Street. Please go ahead.

Great. Appreciate you guys taking the questions. Rob, just to follow up on the Medicare Advantage, aside from maybe a desire just not to pay you, is there any commonality in the reasons for not payment? And what I'm getting at is, is there a trigger which could unlock a substantial portion of that backlog, or is it just a whole mess of individual claims that need to be adjudicated as such?

It's a mess of individual claims, but it's a pretty consistent sort of administrative hurdle. So if we can address the administrative hurdle that's been placed in front of us, it should unlock a good portion of those. And so it's not like we have to deal each on a claim-by-claim basis. I'd say it's a... a more common issue across multiple claims.

Got it, got it. And just sticking with you, Robin, on the gross margins, you indicated that they would stay in the mid to high 70s. So if we call that like a 400 basis point swing, what causes it to move around within that window? You know, what would cause it to be 76 next quarter versus 79 this quarter?

Yeah, it's really a mix. So, you know, if we have a higher biopharma and the biopharma gross margins can be varied based on what the type of contract is. The last couple of quarters have been very strong, which have contributed to our high gross margins. But if we have a contract that comes in that's a slightly lower gross margin and that's a bigger portion of the business for the quarter, then you could see some movement. There's nothing... that we would expect to cause any sort of issues from like a process or productivity standpoint. It's really just mix of tests and biopharma.

Got it, got it. And then just a quick final one. Any whispers on the potential for guidelines changes, particularly with ACCP here in the fall?

Hey Thomas, thanks for the question. You know, we're eager to hear As you highlighted, the CHESS guidelines usually receive some sort of update or adjustment in and around their annual society meeting and conference, which occurs in the October-November timeframe. They have not given any guidance other than to state and comment that it's been nearly 10 years since they have updated them. They're woefully behind, and they've got to make a change. We're eager to see what they are willing to disclose heading into that fall convention timing. We continue to focus on data development and commercially. We're going to do what we can to ensure that anyone that's associated with guidelines has an opportunity to be exposed to our testing. They appreciate the value that it provides and they can go into those discussions with their own experiences that are personal in nature but can help drive broader adoption across the industry. So we feel like we've put ourselves in a good position. And again, we'll wait and see. And that really extends outside of just not just CHESS, but into NCCN and even the Fleischner Guidelines. We continue to make inroads there. And we'll let everybody know as soon as we're informed and hear something. And whether it's this year or not, it is definitely a focus and a priority to continue to develop our tests, develop data, and put ourselves in the best position possible. Great. I appreciate you taking the questions. Thank you. Yeah, thank you, Thomas.

Thank you. This concludes the Q&A session. I will now turn it over to Scott Hutton for closing remarks.

Thank you, Operator. It's an exciting time here at Biodesics. We've worked long and hard to build the best pulmonology-focused commercial team in diagnostics. With first mover status in lung nodule management and an ever increasing body of robust clinical data, we're building on the momentum we created as we further increase our clinical and payer adoption in this extremely large and underserved population. Ultimately, it is all about the healthcare professionals and their patients that they treat. And we believe in our unique ability to scale and have a material impact in the future. We've had a great start to the year, And with a strong balance sheet to execute our plan towards profitability, we view 2024 as a pivotal year of execution, and we look forward to updating you on our continued progress and success on our next earnings call. Thank you.

This does conclude the program. You may now disconnect.