Earnings Call Transcript - BDSX Q1 2024

Chris Brinzey, Investor Relations

Thank you, operator, and good afternoon, everyone. Thank you for joining us today for a discussion of Biodesix' 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.

Scott Hutton, CEO

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 to 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 in 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 6 to 8 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 are achieving growth through additional projects from existing customers as well as new contracts from new customers from an increasing number of incoming requests for proposals 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 Pestano, and Dr. Howard Scher from MSK shared an update on this new collaboration at the 31st International Precision Medicine TRI-CON Meeting. The framework presented demonstrates our pipeline strategy that builds on our strength in product development, quality, reimbursement, and commercialization and gains 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. We shared a number of presentations at the American Association for Cancer Research Annual Meeting. The AACR data demonstrated our 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 Nodify testing that's being conducted at a number of major academic institutions. This study is overseen by a third-party independent data monitoring committee that will be determining updates on potential interim analysis, and we 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 2-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 built a commercial and operational platform that will help facilitate long-term, consistent, sustainable growth. 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 transforming the standard of care in lung cancer and improving 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 Harper Cowie, CFO

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 delays 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 million 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've 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 noncash 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 expenses for the first quarter of 2024 include $4.1 million in noncash stock-compensation expense, noncash 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 an $18.7 million net loss for the same period of 2023 and a $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 expense. 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 noncash 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 noncash items and COVID-19 testing revenue and direct costs and expenses. Adjusted EBITDA for the first quarter of 2024 was a loss of $6.96 million compared to a loss of $13.32 million for the first quarter of 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 fund raise 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 offering of approximately $51.5 million. Subsequent to the end of the quarter on April 1, 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 million to $68 million in total revenue and are excited to deliver on our year of execution.

Scott Hutton, CEO

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% gross 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's 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.

Operator, Operator

Thank you. Our first question comes from Andrew Brackmann from William Blair. Please go ahead.

Andrew Brackmann, Analyst

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

Scott Hutton, CEO

Thank you, Andrew, for your question. We continue to add 6 to 8 sales professionals each quarter, and it usually takes about three months for new hires to become self-sufficient. This consistency gives us confidence in our training and onboarding processes. In the U.S., particularly in the West, some territories remain quite large, which might result in a longer ramp-up time for new hires in those areas. Consequently, these individuals may incur higher operating costs. However, their similar efforts lead us to believe we can sustain growth. We are also assessing our market penetration and adoption, and we recognize we have only begun to explore the vast opportunities available. Over the full year, we aim to maintain our pace of adding 6 to 8 new sales professionals quarterly, expecting to finish the year with around 70 to 72 contributing reps. The critical factor will be how early we can onboard the last cohort and their contributions in the early months of the quarter. We have incorporated this into our strategic planning. Our strategy is based on the productivity and expansion of our sales representatives. We've mentioned the associate sales consultant role; nearly 50% of our sales territories now include one. The makeup of this role will evolve based on productivity, territory size, and growth potential. We're pleased to have introduced and tested this role over a year ago and see significant upside moving forward.

Andrew Brackmann, Analyst

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.

Scott Hutton, CEO

Yes. 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 are 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. We know there are 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 meanwhile decreasing the size of their territory. Those are all on the roadmap and the horizon. 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 said no. For us, it's laser-focused. We are so under-penetrated in this opportunity. We are focused, first and foremost, on really continuing to invest in the sales channel. The reason I state that is in the future, I still believe that the sales team can add two to three, maybe even four more products, as long as they're appropriate for that call point. We are going to find a means by which we do that, whether that's organic or inorganic.

Andrew Brackmann, Analyst

That’s great. Appreciate the time today. Thank you.

Scott Hutton, CEO

Thanks, Andrew.

Operator, Operator

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

Kyle Mikson, Analyst

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

Scott Hutton, CEO

Yes. Thanks, Kyle. Great question. 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, getting the 2024 year off to a great start, putting up a good quarter was our first priority. 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. If anything, we are just being mindful of managing expectations. It's early in the year. I'm certain that we will talk a little bit about the LDT FDA ruling. Some of those uncertainties just cause us to pause and we don't want to get over-extended. But we are very bullish on the year. We feel that we've got a lot of momentum. 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. We are really excited to see that rebound we've been talking about on the Biopharma Services. To put up another strong quarter there and 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. Most of those contracts are reliant on us receiving samples. We'll continue to talk a lot about the upside that we see. For us, it's really about executing, putting up strong performance, and having those conversations at the end of the second quarter.

Kyle Mikson, Analyst

That was great, Scott. Thanks so much. On that note regarding biopharma revenue, the services side is definitely improving. There have been IPOs and private deals. I'm curious about the recent contribution to revenue, particularly the $9 million in contracted revenue. Is this coming from new requests for proposals or the completion of new deals? Will this be the primary source of revenue? Additionally, when the situation in the biotech world stabilizes, could we see a surge of biopharma revenue in the first or second quarter, or will it grow steadily throughout the year, possibly with an increase toward the end?

Scott Hutton, CEO

Yes, it's a great question. For us, as we've focused on 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. More importantly, you become of greater importance to that drug discovery and development effort. We've seen a number of those that have continued. We have seen new requests for proposals come in from new partners, and we are 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 are more on the horizon. They are going to be targets for us moving forward. When it comes to revenue recognition and achievement, it really is dependent upon the type of agreement that we sign and whatever their hypothesis is and what we are trying to help them answer the question to. 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, those are a little bit easier to forecast, but those are going to be spread out over multiple years. 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 will continue in a sustainable fashion for quarters to come. The sales team is out continuing to expand that funnel, so a great opportunity. You highlighted the fundraising market for biopharmaceutical companies. One of the things we saw historically was the year-end push. We haven't seen that recently. We'll keep you updated as we progress through this year to see if we anticipate a significant uptick 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.

Kyle Mikson, Analyst

Thank you, Scott, for that update. I have a final question for Robin that consists of two parts. The first part concerns the unpaid Medicare Advantage claims, which I believe are between $3.5 million and $4.0 million. We've been hearing about this for several quarters now. Is there a risk that you might miss the chance to recognize that revenue after a certain period, or do you have an unspecified timeframe to capture it, suggesting that you should be fine even if it takes years? The second part is regarding the $6 million payment expected in October. How is that structured? Is it included in your operating expenses, or is it an incremental amount spaced out over time? Thank you.

Robin Harper Cowie, CFO

Yes. 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 is no clock for our ability to recognize it. When the cash comes in, that's when we will recognize it. So we are in good shape there, and we will keep you all updated as we make progress. No interaction or transaction with a payer is fast. 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 Integrated Diagnostics. 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 fund raise in April, we prepaid the July 1 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 1 milestone because there is no interest. So there's no real incentive for us to move it forward.

Kyle Mikson, Analyst

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

Scott Hutton, CEO

Thanks, Kyle.

Operator, Operator

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

Thomas Flaten, Analyst

Great. Appreciate you guys taking the questions. Robin, just a 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?

Robin Harper Cowie, CFO

There are significant individual claims, but there is a recurring administrative challenge. If we can resolve this challenge, it should allow us to address a good number of those claims. We don’t need to tackle each claim individually; it appears to be a more widespread issue affecting multiple claims.

Thomas Flaten, Analyst

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 caused it to move around within that window? What would cause it to be 76 next quarter versus 79 this quarter?

Robin Harper Cowie, CFO

Yes, it's really a mix. So if we have a higher biopharma and we've seen 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. 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 a process or productivity standpoint. It's really just a mix of tests in biopharma.

Thomas Flaten, Analyst

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?

Scott Hutton, CEO

Thank you for the question, Thomas. We're looking forward to the updates. As you mentioned, the CHEST guidelines typically see adjustments around their Annual Society Meeting and Conference, which is held around October-November. They haven't provided any specific guidance, only noting that it has been nearly a decade since the last update, which is quite overdue, and changes are necessary. We're keen to learn what they will reveal during that fall event. We remain committed to developing our data. On the commercial side, we will do our best to ensure that those involved with the guidelines are aware of our testing. They recognize its value and can share their personal experiences, which might help promote wider acceptance across the industry. We believe we are well-positioned and will await further updates. This interest extends beyond just CHEST to include NCCN and even the Fleischner guidelines. We are making progress in those areas as well, and we will keep everyone informed as soon as we receive updates. Regardless of whether this year brings changes, we remain focused on advancing our test, gathering data, and positioning ourselves effectively.

Thomas Flaten, Analyst

Great. Appreciate taking the questions. Thank you.

Scott Hutton, CEO

Yes. Thank you, Thomas.

Operator, Operator

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

Scott Hutton, CEO

Thank you, operator. It's an exciting time here at Biodesix. 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 are 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 the patients that they treat. 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. 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.

Operator, Operator

This does conclude the program. You may now disconnect.