Good day and thank you for standing by. Welcome to the Biodesix Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the call over to your speaker today Chris Brinzey of Biodesix Investor Relations, our first speaker for today's conference. Please stand by.

Thank you, operator and good afternoon everyone. Thank you for joining us today for a discussion of Biodesix's second quarter 2023 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 second quarter 2023. 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 Biodesix 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 31st, 2022 filed with Securities and Exchange Commission on March 6th, 2023 as well as subsequent quarterly reports on Form 10-Q filed during the 2023 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. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

Thank you, Chris. Biodesix is a patient-centric, mission-driven lung disease diagnostics company with a mission to unite physicians, patients in biopharma to transform the standard-of-care and improve outcomes with personalized diagnostics. At Biodesix, we've built a comprehensive portfolio of precision diagnostic test to support clinical decision-making across the lung cancer continuum of care. Our core lung diagnostic testing portfolio ranges from initial risk assessment of lung nodules with Nodify Lung testing to post-cancer diagnosis treatment guidance and monitoring with IQLung testing. Nodify Lung consist of two blood-based proteomic test, Nodify CDT and Nodify XL2, which are used by physicians to assess the risk of malignancy of a lung nodule. IQLung consists of three blood-based tests, the GeneStrat NGS genomic test, the GeneStrat-ddPCR-targeted genomic test, and the VeriStrat proteomic test. Offered as options within IQ lung, these three tests are used to inform treatment decisions and monitor for the rise of resistance mutations, while patients are on therapy. All five of our core lung diagnostic tests are covered by Medicare, and we believe we're the only diagnostic company with five on-market tests for lung cancer, all with Medicare coverage. We've made significant strides, and I'm thrilled with our overall performance in the quarter and the first half of the year. We grew lung diagnostic test volumes and revenue, expanded our gross margin to the low 70% ahead of our year-end goal and reduced our operating expense and cash burn. Our commitment to a cost-disciplined approach while growing and expanding the business continues to pay off. And this quarter's results reinforced the team's progress and outstanding execution on our path to profitability. In addition, we successfully completed a fundraising effort through a private placement, raising $27.5 million in equity funding subsequent to quarter end, to further support our growth and provide near-term…

Thanks, Scott. Second quarter total revenue was $11.9 million, an 8% increase over the prior year, including COVID revenue and a 48% increase over the prior year, excluding COVID revenue of $3.0 million from COVID testing volumes in the second quarter of 2022. Core lung diagnostic revenue in the second quarter was $11.4 million, compared to $7.3 million for the second quarter of 2022, an increase of 58% over the prior year. In the quarter, we recorded total lung diagnostic test volumes of approximately 9,800 versus approximately 5,600 for the second quarter of 2022, a 75% increase. The test volume growth was primarily driven by our Nodify nodule management lung testing, which includes Nodify XL2 and Nodify CDT. The difference in growth rates between volumes and revenue was primarily driven by the timing of Medicare coverage for Nodify CDT achieved in the second quarter 2022. Biopharmaceutical Services revenue was $423,000 in the quarter, compared to $744,000 in the second quarter of 2022 and $411,000 in the first quarter of 2023, a decrease of 43% compared to the second quarter 2022 and an increase of 3% over the first quarter of 2023. As a reminder, this business can fluctuate due to several factors, including contract timing and project execution, but in this instance, reflects the continued delays of enrollment in prospective clinical trials to complete the projects and recognize revenue. As Scott mentioned, we ended the second quarter of 2023 with $9.3 million contracted but not yet recognized as revenue. These dollars are tied to multiple agreements with different time lines and will be recognized as these projects are executed. Gross margin percentage in the second quarter 2023 was 73% versus 64% in the prior year quarter and 65% in the first quarter of 2023. Current gross margin trends reflect the…

Thanks, Robin. In closing, I want to express my gratitude to all the incredible members of the Biodesix team, who've shown unwavering belief in and dedication to our mission, vision and culture. Our collective commitment and daily contributions are centered around making a positive impact on the lives of patients and I'm truly thankful for your efforts. We have again experienced remarkable double-digit growth in the past quarter, attributed to the exceptional performance of our long focused sales team who have been instrumental in fueling our growth and success. We've published critical clinical data that demonstrates the utility of our test supporting both physician and payer adoption and achieved a major reimbursement milestone. Additionally, we've improved our already strong gross margins ahead of plan. Looking ahead, our focus remains on driving near-term revenue growth while maintaining a disciplined approach in reducing expenses and cash burn. By aligning these strategic priorities, we are confident in our ability to sustain our growth trajectory, make progress on our path to profitability and deliver value to our shareholders. We look forward to moving into our new state-of-the-art facility that affords us the opportunity to maintain our growth and expand in an efficient and effective manner. Once again, I extend my sincere appreciation to each and every member of the Biodesix team for your invaluable contributions to our success. Together, we're making a real difference and positively impacting physicians and the patients they treat. Robin, the Biodesix team and I are as excited as we've ever been about the future of Biodesix and the opportunities that lie ahead. With that, I'll turn the call over to the operator for questions.

Thank you. We will now conduct a question-and-answer session. [Operator Instructions] Our first question comes from the line of Andrew Brackmann. Your line is now open.

Hey, everyone. This is Maggie Boeye on today for Andrew. Thanks for taking our questions. Maybe first to start on the guidance for the year. You reiterated your top line outlook today. Can you talk about kind of the pacing for the third and fourth quarter within these assumptions, maybe both on the core lung diagnostics side and then the biopharma services side?

Yeah. Hi, Maggie, thanks for hopping on. We haven't seen -- or we don't expect any real change in the pacing for the quarters. We still expect it to look sort of like what we saw last year, with a step up in the third quarter and then a further step up in the fourth. With our biopharma services, that one is the one that is more -- more difficult to predict. It's very lumpy. We've seen great interest coming into the company, more request for proposals than ever before. But just things are slow and sort of delayed. So that one, we hope to see some good uptick in the second half of the year, but put more strength and more emphasis on the lung nodule management and lung diagnostics portion of the revenue.

Got it. That makes sense. And maybe just one on volume growth on that core lung sides. So you've now had two really strong quarters of growth in a row. Can you maybe break apart that growth and talk about how much of its being driven by greater existing account utilization or even new account utilization or any other geography [ph] here? Thank you.

Yes. Thank you, Maggie. This is Scott. Appreciate the question. Yes. As we stated before, we've had and experienced great interest and adoption really across all pulmonology groups, which also includes kind of community, rural and academic. So we continue to see growth across all segments. We think that the Oracle publication will continue to increase that. And we're exceptionally pleased with the sales rep access. So for us, there's not one specialty within the pulmonology group where we're seeing greater or less adoption. It really is equal. And I think it speaks volumes about the clinical utility, which was also supported in Oracle, where we demonstrated a 74% reduction in unnecessary invasive procedures.

Great. Thanks so much.

Thank you, Maggie.

Thank you. Please stand by for our next question. Thank you. Our next question comes from the line of Kyle Mikson of Canaccord Genuity. Your line is now open.

Great. Hey, guys. Thanks for taking my questions. Congrats on the quarter. So a similar line of thoughts, the 75% growth year-over-year for test volume, I'm just -- I guess, like could you like just parse out how much of that Scott is from recurring, sort of, like stickiness among clinicians and reordering? I think that's an interesting dynamic that like such outsized growth, it seems like it's a lot of like inorganic almost, but a lot of your tests have been on the market for a while and have Medicare coverage for a year. So if you could just double click on that, I'd be kind of good to hear?

Yes. Thanks, Kyle. Appreciate the question. Yes. We haven't disclosed that metric. Obviously, we track that closely. What I'm comfortable sharing today is that we've been pleased really with that stickiness in that reorder rate. And we've seen that not only stay, kind of, consistently strong, but grow over time, which is what you want, right? As an individual physician or healthcare practice gains experience, you hope they see the greater value in the clinical utility of the test. And that's consistent with what we've seen as we've tracked this over time. One of the other metrics we've looked at, and again, we don't share the actual results publicly is as somebody onboards and begin ordering the test and applying those test results, at what point in time do they become sticky. And so for us, we really -- we expect to get into that 10 to 20 tests per account or physician range. And then we go in and we focus on what we call kind of a clinical utility review with them to make certain that they understand how each test results not only impacted that individual patient, but potentially changed their approach. And so that's resonated for us over time. But it's a great question. It is critically important to us, and we see it equal value in not only getting ordering physicians to continue to order and continue to order more, but also for our sales professionals to go out and open new accounts.

Okay. That was great, Scott. Thanks for that. And -- so the nodule management side of the business continues to really drive a lot of this growth here. But I'm just curious, the other side where Strat -- GeneStrat the treatment guidance. Can you talk about like the competitive dynamics that are happening in that market? And maybe like your penetration, how that has been progressing, as if you don't really hear about that as much on these calls.

Yes. No, it's a good point. The IQLung portion of our test, which includes VeriStrat, GeneStrat NGS and GeneStrat ddPCR. Thet GeneStrat portion is our genomic offering. We see and receive great value and feedback in offering both a broad-based NGS panel and the targeted ddPCR panel. I think where the greatest value is on the targeted panel is turnaround time, right? Getting the physician, those genetic results that they need in less than 36 hours. That's critical, especially early-stage disease before you prescribe treatment. We introduced, as you said, the NGS test more recently and we felt like that complemented the ddPCR test. We are the only company out there offering both in that clinical setting. But again, I think part of our reach limitations are based upon focusing specifically on lung cancer. So where the NGS test has a broader application. Our sales professionals have stayed kind of focused on lung cancer. And so we know that we aren't expecting to hit significant competitive conversions and drive up that market share list on the NGS front. For us, it's more about being that trusted consultative sales company that physicians go to for the answers they need in lung disease and lung cancer.

Perfect. And on the gross margins, this is great to see the 73% low 70s, already kind of approaching mid-70s. And it sounds like we should expect low 70s going forward. So that is helpful guidance, I guess, just to model out. But I was just curious how the kind of tempered biopharma revenue is going to impact gross margins going forward too. I know it's probably somewhat uncertain and hard to predict, but I was just curious if you guys could just comment on that.

Yes, it's a great question, and I think you kind of answered it. It is uncertain because we did state that we've got $9.3 million under contract, we're able to forecast and plan accordingly. And we have taken that into account. So when we state that we fully expect to stay in that low 70% range, that's inclusive of the biopharmaceutical agreements that we currently have in place. Now as that -- as our biopharmaceutical team is out there trying to get more contracts, that can obviously change and shift, but we don't see that directionally, negatively impacting gross margins in the near future.

Awesome. And then just a final one for me. Rob, you talked about the -- you guys are moving into the facility. Is there any CapEx implications from that, or is it already kind of built out and everything?

Yes, there is. So we have -- still have some tenant improvement dollars that we expect to exhaust here in the third quarter, and then there'll be some CapEx in third quarter and fourth quarter. We moved towards the end of -- well, at the end of the year and will be live in the new laboratory facility for 2024. So we're not performing tests in the new facility until the New Year. So we would expect to see sort of the consistent CapEx in third and fourth quarter like we've seen in first and second.

So there wouldn't be like a step up temporarily?

No step up in the amount of CapEx, but a step down in the tenant improvement dollars that come in. So we'll exhaust that here in the third quarter and then the final amount will be all out of pocket the CapEx.

Interesting. Thanks Robin, thank you, Scott. Congrats guys.

Thank you, Kyle.

Thank you. Our last question comes from the line of Tejas Savant of Morgan Stanley. Your line is now open.

Hello, this is Yuko on the call for Tejas. Thank you for taking our question. Just following-up on some of the biopharma business comments here. Could you comment on how delays on prospective clinical trial enrollment and sample delivery has trended over the course of the quarter and into July? And also could you provide a degree of customer concentration for the $9.3 million under contract?

Hi Yuko. Thanks for the question. Yes, when we think about the trends, one of the things that we have found encouraging and we're excited about is we have seen access to retrospective samples and prospective trial enrollment increase in pick up. And so we've been watching that closely over time and really been waiting for that. The nice thing about having the significant amount of dollars under contract that we have is knowing that it really comes back to access, timing, and cadence. And so we feel like there is movement and progress there, and that's encouraging for us. We've also seen a record number of request for proposals moving forward and so we feel like we're in a really, really strong position. When we break down those requests for proposals and the $9.3 million currently under contract, we haven't really disclosed what the tests are. We offer all of our commercial tests as part of our biopharmaceutical offering and then we offer a number of additional tests, both tests that we have created and offer for RUO use and just have chosen to not commercialize, but also we offer custom assay development. And so it really is a broad spectrum of different projects and tests or assays that we're offering and the biopharmaceutical partners are really coming to us at varied stages of their own development and research. So, we feel like we're fairly balanced. We're also balanced, I'd say, across size of the biopharmaceutical companies, where we've got some small biopharmaceutical companies coming in along with some of the major more significant names that everybody might know. Is that helpful, Yuko?

Yes, that was great. Thank you so much Scott. Also, with the upcoming CHEST Conference, what presentation and presence do you anticipate to have there? It's a conference that you are historically been present at. And then is it possible that we could see interim data from ALTITUDE at CHEST?

Yes. Great question. We look towards the annual CHEST meeting as one of the biggest opportunities for us. If you're not familiar with it, it's the largest Pulmonology Society -- Physician Society Conference on an annual basis, usually held in October and November. This year's meeting has been pulled up, so it's early October. We're not yet able to disclose exactly what will be presented and published as a number of the items that we've already had accepted are embargoed until we get closer to the event. And we've got a number of other efforts that are still in the works. We put a lot of pressure on ourselves to make certain that we show up, representing who we are. And so we think this CHEST will be equally as impactful as the last where we have an opportunity to get in front of a number of pulmonologists with an ever-increasing book of data. And so we're excited about that. Getting the Oracle data out now when we could give them more time to digest it, to research it on their own. And so we fully expect to have great robust conversation there. And then the second part, yes. I was just going to say sorry, go ahead, Yuko.

No, no, no, go ahead.

Yes. So for us, when we look towards interim data on altitude, it really is going to be based upon enrollment. We're very pleased with enrollment, we've had a number of back-to-back months with record number of enrollments. So I don't expect to have interim data or analysis that we'd be sharing at CHEST because we would already be doing that analysis. I think as we get closer to the end of the year, we'll look at that and maybe do an interim analysis share sooner in the year next year, not waiting for CHEST. But it's critically important for us. We know that a prospective randomized trial in this space is significant, more excited to get that data out there. And we're really proud to be working with a number of major academic institutions that we are on that study.

Great. Thank you so much for the color.

Yes. Thank you, Yuko

Thank you for your question. This now concludes our question-and-answer session. I'd now like to pass the call back over to Scott Hutton, Chief Executive Officer for Biodesix for closing remarks.

Thank you, operator. We've worked long and hard to build the best pulmonology focused sales team in diagnostics. And I think that's just the beginning of our growth. With a first-mover status in lung nodule management and an ever-increasing body of robust clinical data, we're eager to provide updates on our progress and how we continue to build on the momentum already created, as we increase our clinical data and payer adoption in this extremely large market opportunity. Ultimately, it's all about physicians and the patients they treat, and we believe in our ability to make a more significant impact in the future. Our research, development and laboratory teams are continuously delivering on operational improvements and cost savings, maintaining a high level of compliance and positively impacting our already strong gross margins while exceeding our standard of best-in-class operations as evidenced by our unmatched turnaround times on test results delivery. We've prioritized a quality-focused Biodesix team and culture and trust that our cost discipline approach and resulting reduction in operating expense and cash burn will provide greater clarity and assurance around our path to profitability. We look forward to updating you on our continued progress and successes on the next earnings call and hosting you in our new state-of-the-art and highly accredited facility soon. Thank you.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.