NASDAQ:BDSX Biodesix Q2 2023 Earnings Report $0.47 -0.04 (-8.44%) Closing price 04:00 PM EasternExtended Trading$0.48 +0.01 (+2.05%) As of 05:09 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Biodesix EPS ResultsActual EPS-$0.17Consensus EPS -$0.21Beat/MissBeat by +$0.04One Year Ago EPSN/ABiodesix Revenue ResultsActual Revenue$11.87 millionExpected Revenue$11.38 millionBeat/MissBeat by +$490.00 thousandYoY Revenue GrowthN/ABiodesix Announcement DetailsQuarterQ2 2023Date8/7/2023TimeN/AConference Call DateMonday, August 7, 2023Conference Call Time4:30PM ETUpcoming EarningsBiodesix's Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Biodesix Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 7, 2023 ShareLink copied to clipboard.There are 7 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the BioDesk's 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. Please be advised that today's conference is being recorded. Operator00:00:38I would now like to hand the call over to Chris Frenze of Investor Relations, our first speaker for today's conference. Please stand by. Speaker 100:00:54Thank you, operator, and good afternoon, everyone. Thank you for joining us Today for a discussion of BioDesk's Q2 2023 business highlights and financial results. Leading the call today will be Scott Hutton, Chief Executive Officer. He will be joined by Robin Harper Kaui, Chief Financial Officer. After the prepared remarks, we will open the call Q and A. Speaker 100:01:15An 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 Q2 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 Changing market trends, reduced demand and the competitive nature of the BioDessics industry. Such forward looking statements and their implications involve known and unknown risks, 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 ks for the year ending December 31, 2022, filed with the Securities and Exchange Commission on March 6, 2023, as well as subsequent quarterly reports on Form 10 Q filed during the 2023, as applicable. Speaker 100:02:24Additional 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? Speaker 200:02:42Thank you, Chris. BioDessics is a patient centric, mission driven lung disease diagnostics company with a mission to unite physicians, patients and biopharma to transform the standard of care and improve outcomes with personalized diagnostics. At BioDessics, we've built a comprehensive portfolio of precision diagnostic tests 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 Notify Lung Testing to post cancer diagnosis treatment guidance and monitoring with IQ Lung Testing. Notify Lung consists of 2 blood based proteomic tests, Notify CDT and Notify XL2, which are used by physicians to assess the risk of malignancy of a lung nodule. Speaker 200:03:40IQ Lung consists of 3 blood based tests: The GenoStrat NGS genomic test, the GenoStrat ddPCR targeted genomic test and the Verastat proteomic test. Offered as options within IQLUN, these three tests are used to inform treatment decisions And monitor for the rise of resistance mutations while patients are on therapy. All 5 of our core lung diagnostic tests are covered by Medicare, and we believe we're the only diagnostics company with 5 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 reinforce the team's progress and outstanding execution on our path to profitability. Speaker 200:04:53In addition, we successfully completed a fundraising effort through a private placement, raising $27,500,000 in equity funding subsequent to quarter end to further support our growth and provide near term financial flexibility. 100% of the funds raised through this private placement were from insiders, including all Board members, All Section 16 officers and additional members of the leadership team, which continues to signify our confidence in the future of the company and the extraordinary value that we believe exists. Time and time again, our long term investors have demonstrated their steadfast support An unwavering commitment because they too believe in the BioDessics team and our goal to make a significant impact in the care of those patients with lung disease. In the Q2, we reported total revenue of $11,900,000 which excluding non core revenue from COVID represented growth of 48% compared to the same period a year ago. The quarter was again highlighted by the impressive growth in our core lung diagnostic testing business, which generated revenue of $11,400,000 reflecting approximately 58% year over year growth. Speaker 200:06:13We reported overall gross margins of 73%, a significant improvement over the 64% gross margins reported In the Q2 of 2022 and the 65% gross margins reported in the Q1 of this year. We are exceptionally pleased that our core lung diagnostic sales efforts continue to gain momentum during the Q2 As the number of tests delivered reached the highest in company history for the 2nd consecutive quarter, increasing by 75% compared to the Q2 of 2022 and nearly matching the 78% year over year growth we saw in the Q1. The test volumes also represent a 29% sequential increase over the Q1 of 2023. This strong growth continues to be primarily driven by our Notify Lung testing volumes. Our sales team continues to benefit from regular interaction with physicians and care teams, and we are actively participating and an increasing number of peer to peer physician educational events. Speaker 200:07:20It is worth noting that the positive momentum we witnessed throughout the second quarter has carried over into the start of the Q3, further reinforcing our satisfaction with the team's progress and performance. To further support our clinical adoption and reimbursement, we were pleased to have recently shared several updates on clinical studies that build upon and support the clinical utility of our Notify Lung and IQ Lung testing strategies. In May, we presented original data in 4 separate poster presentations at the International Society For Pharmaceutical and Outcomes Research conference, providing evidence of the health economic benefit of the Notify CDT and Notify XL2 test in the management of pulmonary nodules. Most recently in July, we were thrilled to share data from the prospective real world ORACLE study, An observational registry study to evaluate the performance of the NOTIFY XL2 test. It is important to remember that demonstrating clinical utility Is a critical step necessary to drive adoption of any diagnostic test and we're excited that the ORACLE study successfully achieved its primary endpoint demonstrating a 74% reduction in unnecessary invasive procedures. Speaker 200:08:42Overall, the findings from the ORACLE study represent a significant advancement in the clinical evidence for use of the NOTIFY XL2 test in nodule management. In addition to the Oracle publication, Physicians from Beth Israel Deaconess, Tulane University and Einstein Medical Center published an independent third party Multi center study demonstrating that the use of the NOTIFY XL2 test resulted in a 73% reduction in the number of unnecessary invasive procedures conducted on benign nodules as compared to the control arm. Looking ahead, we anticipate sharing additional data and updates on other studies, including our Incyte study assessing the clinical effectiveness of Verastat, our proprietary blood based proteomic immune profiling test At the upcoming International Association For the Study of Lung Cancer World Conference on Lung Cancer being held in Singapore in September and additional abstracts at the annual CHEST meeting being held in Hawaii in October. In addition to the growth in volumes driven by our sales team, Broadening reimbursement coverage remains an important part of our growth strategy. In July, the BioDessics Notify CDT test Was awarded Advanced Diagnostic Laboratory Test or ADLT status by the Center For Medicare and Medicaid Services. Speaker 200:10:09Receiving ADLT status is a major milestone for the BioDosix team as this status is reserved for innovative tests with Medicare coverage that provide clinical value and new diagnostic information that cannot be obtained from any other test or combination of tests, recognizing the unique utility of the Notify CDT test. Now, BioDeskix has 3 tests, Notify CDT, Notify XL2 and Verastrat, all with ADLT status. We'll continue to expand and build upon our reimbursement coverage and expect to have additional updates in the second half of the year. Moving on to our biopharmaceutical partnerships and services business. In the second quarter, We reported revenue of $423,000 which grew slightly over the Q1, but it's still an area that continues to be impacted by delayed enrollment in clinical trials. Speaker 200:11:06We remain bullish on the biopharmaceutical partnership and service business as we continue to have a strong backlog and incoming requests for proposals. And we ended the quarter with $9,300,000 under contract, but not yet recognized. While we're encouraged by the continued strength in the backlog, we assume the challenges our biopharma partners are experiencing will remain for the next few quarters as projects slow and in some cases are delayed beyond the originally expected timelines. I've emphasized this point before and cannot stress it enough. 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 3 deadliest cancers, breast, prostate and colon cancer. Speaker 200:11:55Time is of the essence when it comes to diagnosing and treating these patients. At biodessics, we take great pride in our capability and capacity to healthcare professionals and care teams swiftly. We strive to offer the best testing turnaround times in the industry for all our tests with the goal of improving patient outcomes. Our company and team experienced a strong quarter and first half of the year. We maintain confidence in our ability to sustain this momentum, driving continued growth in test volumes and revenue throughout the second half of the year and beyond. Speaker 200:12:39Now let me turn it over to Robin to review the Q2 2023 financial performance. Robin? Speaker 300:12:46Thanks, Scott. 2nd quarter total revenue was $11,900,000 an 8% increase over the prior year, including COVID revenue and a 48% increase over the prior year excluding COVID revenue of $3,000,000 from COVID testing volumes in the Q2 of 2022. Core lung diagnostic revenue in the Q2 was $11,400,000 compared to $7,300,000 for the Q2 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 Q2 of 2022, a 75% increase. The test volume growth was primarily driven by our Notify nodule management lung testing, which includes Notify XL2 and Notify CDT. Speaker 300:13:39The difference in growth rates between volumes and revenue was primarily driven by the timing of Medicare coverage for Notify CDT achieved in the Q2 of 2022. Biopharmaceutical Services revenue was $423,000 in the quarter compared to $744,000 in the Q2 of 2022 And $411,000 in the Q1 of 2023, a decrease of 43% compared to the Q2 of 20 22 and an increase of 3% over the Q1 of 2020. 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 Q2 of 2023 with $9,300,000 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. Speaker 300:14:39Gross margin percentage in the Q2 2023 was 73% versus 64% in the prior year quarter and 65% in the Q1 of 2023. Current gross margin trends reflect the growth in our higher Gross Margin Lung Diagnostic Testing Business, successful completion of projects to decrease costs and optimize testing workflows And cessation of commercial COVID testing. This margin achievement is ahead of plan and we anticipate maintaining margins in the low 70s going forward. Overall operating expense, excluding direct costs and expenses, was $19,600,000 in the Q2 of 2023 compared to $6,000,000 for the same period of 2022 $22,300,000 in the Q1 of 2023. The increase versus last year is primarily from increased sales and marketing expense from increased travel related costs due to the return to pre pandemic level access to physicians and increases in other non employee related costs. Speaker 300:15:42The decrease as compared to the Q1 is related to the realization of savings from our Prioritization of projects that are expected to result in near term revenue and the delay of longer term projects. Operating expense for the Q2 2023 includes $1,100,000 in non cash stock compensation expense as compared to $1,400,000 during the Q2 2022 $2,300,000 in the Q1 of 2023. Net loss for the Q2 2023 was $13,400,000 compared to a $15,800,000 net loss for the same period of 2022 and $18,700,000 for the Q1 of 2023, driven partially by the improvements in gross margin and operating expenses. The decrease in net loss for the quarter included a decrease in non cash stock based compensation and the absence of a onetime loss on extinguishment In the year ago quarter of $3,000,000 resulting from the restructuring of the contingent consideration agreement with Integrated Diagnostics, offset by an increase in interest expense primarily associated with the Perceptive Term loan facility. If we remove the 800 dollars 1,000 from depreciation and amortization, dollars 1,100,000 from stock based compensation and $2,400,000 in interest expense. Speaker 300:17:01The loss for the Q2 was $9,100,000 as compared to $13,200,000 when making the comparable adjustments to Q1 of 2023, a decrease of 31%. We ended the quarter with $17,400,000 in unrestricted cash and cash equivalents as compared to $25,300,000 in unrestricted cash and cash equivalents at the end of the Q1, a decrease of $7,900,000 which included the scheduled milestone payment of $2,300,000 paid in April 2023 to Integrated Diagnostics, Change in working capital and also includes $5,800,000 in tenant improvement dollars offset by $6,200,000 in investment in the new facility. The cash burn decreased from $17,800,000 in the Q1 of 2023 as a result of our commitment to a cost disciplined approach in growing the business. The cash balance as of June 30, 2023 does not include the $27,500,000 raised in the private placement previously discussed, which was completed subsequent to quarter end. In the upcoming Q4, we expect to move into our new state of the art facility in Louisville, Colorado, just down the road from our current Boulder location. Speaker 300:18:15The new facility has improved capacity for lung diagnostic testing, Biopharmaceutical Services Testing and Collection Kit Manufacturing, which we brought in house in 2022. During the construction of the new facility, Materials and equipment were incorporated to optimize energy efficiency and reduce emissions, advancing some of our longer term ESG goals. We remain focused on 2 major goals, growing our revenue by helping more physicians treat more patients than ever before and making sequential progress on our path to profitability. 2nd quarter results showed our progress and success towards both of those goals, And we are maintaining the guidance provided earlier this year of full year 2023 revenue of $52,000,000 to 55,000,000 Our guidance assumes continued strong year over year growth in our core lung diagnostic testing business, broader reimbursement of our 5 on market tests, as well as modest expected growth in our biopharmaceutical services business. Now let me turn it back to Scott. Speaker 300:19:18Scott? Speaker 200:19:19Thanks, Robin. In closing, I want to express my gratitude to all the incredible members of the BioDessics 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 loan focused sales team, who've 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. Speaker 200:20:08Additionally, 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 BioDessics team for your invaluable contributions to our success. Speaker 200:20:55Together, We're making a real difference and positively impacting physicians and the patients they treat. Robin, the BioDeskix team and I Are as excited as we've ever been about the future of biodesics and the opportunities that lie ahead. With that, I'll turn the call over to the operator for questions. Operator00:21:16Thank you. We will now conduct a question and answer session. Our first question comes from the line of Andrew Brackman. Your line is now open. Speaker 400:21:53Hey, everyone. This is Maggie Buie 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. Speaker 400:22:05Can you talk about kind of the pacing for the 3rd Q4 within these assumptions, maybe both on the core lung diagnostic side and then the biopharma services side? And then the biopharma services side? Speaker 300:22:17Yes. 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 Q3 and then further step up in the 4th. Speaker 300:22:38With our biopharma services, that one is the one that is More difficult to predict. It's very lumpy. We've seen great interest Coming into the company, more requests 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. Speaker 400:23:23Got it. That makes sense. And maybe just one on volume growth on that core lung side. So you've now had 2 really strong quarters of growth in a row. Can you maybe Break apart that growth and talk about how much of it's being driven by greater existing account utilization or even new account utilization or any other drivers here? Speaker 400:23:42Thank you. Speaker 500:23:44Yes. Speaker 200:23:44Thank you, Maggie. This is Scott. Appreciate the question. Yes, as we've stated before, we've Had and experienced great interest in adoption really across all pulmonology groups, which also includes kind of community, rural And academic. So we continue to see growth across all segments. Speaker 200:24:05We think that the Oracle publication will continue to increase that. 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. Speaker 400:24:37Great. Thanks so much. Speaker 200:24:39Thank you, Maggie. Operator00:24:41Thank you. Please standby for our next question. Thank you. Our next question comes from the line of Kyle Nixon of Canaccord Genuity. Your line is now open. Speaker 500:25:02Great. Hey, guys. Thanks for taking the questions. Congrats on the quarter. So similar line of thoughts, this took the 75% growth year over year for test volume. Speaker 500:25:11I guess, like, could you like just parse out how much of that, Scott, is from recurring sort of like Among clinicians and reordering, I think that's like an interesting dynamic that this is like such outsize 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 years. So I'd be if you could just double click on that, it'd be kind of good to hear. Speaker 200:25:34Yes. Thanks, Kyle. Appreciate the question. We haven't disclosed that metric. Obviously, we track that closely. Speaker 200:25:41What 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 begins ordering the test and applying those test results, at what point in time do they become sticky? Speaker 200:26:26And so We really, we expect to get into that 10 to 20 test 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 result 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. Speaker 500:27:10Okay. That was great, Scott. And the 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 Verastat, Janusrat, the Can you talk about like the competitive dynamics that are happening in that market and maybe like your penetration and how that has been progressing because we don't really hear about it as much on these calls? Speaker 200:27:31Yes. No, it's a good point. The IQ lung portion of our test, which includes Verastat, Genostrat NGS and Genostrat DD PCR. The Genostrat 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. Speaker 200:27:55I 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 More recently, and we felt like that complemented the ddPCR test. We are the only company out there offering both In that clinical setting. Speaker 200:28:26But 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 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. Speaker 500:29:04Perfect. And on the gross margin, this is great to see the 73% low 70s already kind of approaching mid-70s. 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 bio Pharma revenue is going to impact gross margins going forward too. Speaker 500:29:25I know it's probably somewhat uncertain and hard to predict, but I was just curious if you guys could just comment on that. Speaker 200:29:30Yes. It's a great question and I think you kind of answered it. It is uncertain because we did state that we've got $9,300,000 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. Speaker 200:29:55Now 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. Speaker 500:30:10Awesome. And then just a final one for me. Rob, you talked about the you guys are moving into a new facility. Is there any CapEx implications from that or is it already kind of built out and everything? Speaker 300:30:21Yes, there is. So we have still have some tenant improvement dollars that we Expect to exhaust here in the Q3 and then there'll be some CapEx in Q3 Q4. We move towards the end of the well, at the end of the year, and we'll 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 expect to see sort of the consistent CapEx in 3rd and 4th quarter like we've seen in 1st and second. Speaker 500:31:05So there wouldn't be like a step up temporarily? Speaker 300:31:11No step up in the amount of CapEx, but step down in the tenant improvement dollars that come in. So we'll exhaust that here in the 3rd Operator00:31:45Our last question comes from the line of Tejas Savant of Morgan Stanley. Your line is now open. Speaker 600:31:53Hello. 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 in prospective clinical trial enrollment and sample delivery has trended over the And also could you provide a degree of customer concentration for the $9,300,000 under contract? Speaker 200:32:18Hi, Hugo. 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 pickup. 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. Speaker 200:32:52And so we feel like there is movement and progress there, and that's encouraging for us. We've also seen a record number of requests 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 $9,300,000 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. Speaker 200:33:25And 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 Their own development and research. So we feel like we're fairly balanced. We're also balanced I 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. Speaker 200:34:11Is that helpful, Yuko? Speaker 600:34:12Yes, that was great. Thank you so much, Scott. Also with the upcoming chess conference, what presentation and presence do you anticipate to have there since 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 CHAS? Speaker 200:34:31Yes. 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 November. This year's meeting has been pulled up, so it's early October. Speaker 200:34:53We'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. Speaker 200:35:37And 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. Speaker 600:35:49No, no, no. Go ahead. Speaker 200:35:52Yes. 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 enrollment. So, I don't expect to have interim Data analysis that we'd be sharing at CHEST because we would already be doing that analysis. Speaker 200:36:18I 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 prospective randomized trial in this space is significant. We're excited to get that data out there. And we're really proud to be working with the number of major academic institutions that we are on that study. Speaker 600:36:48Great. Thank you so much for the color. Speaker 200:36:51Yes. Thank you, Yuko. Operator00:36:54Thank 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 BioDeskix for closing remarks. Speaker 200:37:07Thank you, operator. We 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 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 result delivery. We've prioritized a quality focused Biodesic's team and culture And trust that our cost discipline approach and resultant reduction in operating expense and cash burn will provide greater clarity and assurance around our path to profitability. Speaker 200:38:23We 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 artRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallBiodesix Q2 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Biodesix Earnings HeadlinesCanaccord Genuity Group Cuts Biodesix (NASDAQ:BDSX) Price Target to $2.50May 2 at 2:41 AM | americanbankingnews.comBiodesix, Inc. 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Sign up for Earnings360's daily newsletter to receive timely earnings updates on Biodesix and other key companies, straight to your email. Email Address About BiodesixBiodesix (NASDAQ:BDSX) operates as a data-driven diagnostic solutions company in the United States. The company offers blood-based lung tests, including Nodify XL2 and Nodify CDT tests, together marketed as part of Nodify Lung Nodule Risk Assessment testing strategy, to assess the risk of lung cancer and help in identifying the appropriate treatment pathway and help physicians in reclassifying risk of malignancy in patients with suspicious lung nodules. It also provides GeneStrat ddPCR and NGS, and VeriStrat tests, which are used in the diagnosis of lung cancer to measure the presence of mutations in the tumor and the state of the patient's immune system to establish the patient's prognosis and help guide treatment decisions. In addition, the company, through its partnership with Bio-Rad Laboratories, Inc., provides Bio-Rad SARS-CoV-2 ddPCR, a COVID-19 Test under Biodesix WorkSafe testing program; and Platelia SARS-CoV-2 Total Ab test, an antibody test for detecting a B-cell immune response to SARS-CoV-2 that indicate recent or prior infection. Further, it offers diagnostic and clinical research, as well as clinical trial testing services to biopharmaceutical companies; and discovers, develops, and commercializes companion diagnostics. The company was formerly known as Elston Technologies, Inc. and as changed to Biodesix, Inc. in 2006. Biodesix, Inc. was incorporated in 2005 and is headquartered in Louisville, Colorado.View Biodesix ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Is Reddit Stock a Buy, Sell, or Hold After Earnings Release?Warning or Opportunity After Super Micro Computer's EarningsAmazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousRocket Lab Braces for Q1 Earnings Amid Soaring ExpectationsMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback Plan Upcoming Earnings American Electric Power (5/6/2025)Advanced Micro Devices (5/6/2025)Marriott International (5/6/2025)Constellation Energy (5/6/2025)Arista Networks (5/6/2025)Brookfield Asset Management (5/6/2025)Duke Energy (5/6/2025)Energy Transfer (5/6/2025)Mplx (5/6/2025)Ferrari (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 7 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the BioDesk's 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. Please be advised that today's conference is being recorded. Operator00:00:38I would now like to hand the call over to Chris Frenze of Investor Relations, our first speaker for today's conference. Please stand by. Speaker 100:00:54Thank you, operator, and good afternoon, everyone. Thank you for joining us Today for a discussion of BioDesk's Q2 2023 business highlights and financial results. Leading the call today will be Scott Hutton, Chief Executive Officer. He will be joined by Robin Harper Kaui, Chief Financial Officer. After the prepared remarks, we will open the call Q and A. Speaker 100:01:15An 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 Q2 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 Changing market trends, reduced demand and the competitive nature of the BioDessics industry. Such forward looking statements and their implications involve known and unknown risks, 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 ks for the year ending December 31, 2022, filed with the Securities and Exchange Commission on March 6, 2023, as well as subsequent quarterly reports on Form 10 Q filed during the 2023, as applicable. Speaker 100:02:24Additional 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? Speaker 200:02:42Thank you, Chris. BioDessics is a patient centric, mission driven lung disease diagnostics company with a mission to unite physicians, patients and biopharma to transform the standard of care and improve outcomes with personalized diagnostics. At BioDessics, we've built a comprehensive portfolio of precision diagnostic tests 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 Notify Lung Testing to post cancer diagnosis treatment guidance and monitoring with IQ Lung Testing. Notify Lung consists of 2 blood based proteomic tests, Notify CDT and Notify XL2, which are used by physicians to assess the risk of malignancy of a lung nodule. Speaker 200:03:40IQ Lung consists of 3 blood based tests: The GenoStrat NGS genomic test, the GenoStrat ddPCR targeted genomic test and the Verastat proteomic test. Offered as options within IQLUN, these three tests are used to inform treatment decisions And monitor for the rise of resistance mutations while patients are on therapy. All 5 of our core lung diagnostic tests are covered by Medicare, and we believe we're the only diagnostics company with 5 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 reinforce the team's progress and outstanding execution on our path to profitability. Speaker 200:04:53In addition, we successfully completed a fundraising effort through a private placement, raising $27,500,000 in equity funding subsequent to quarter end to further support our growth and provide near term financial flexibility. 100% of the funds raised through this private placement were from insiders, including all Board members, All Section 16 officers and additional members of the leadership team, which continues to signify our confidence in the future of the company and the extraordinary value that we believe exists. Time and time again, our long term investors have demonstrated their steadfast support An unwavering commitment because they too believe in the BioDessics team and our goal to make a significant impact in the care of those patients with lung disease. In the Q2, we reported total revenue of $11,900,000 which excluding non core revenue from COVID represented growth of 48% compared to the same period a year ago. The quarter was again highlighted by the impressive growth in our core lung diagnostic testing business, which generated revenue of $11,400,000 reflecting approximately 58% year over year growth. Speaker 200:06:13We reported overall gross margins of 73%, a significant improvement over the 64% gross margins reported In the Q2 of 2022 and the 65% gross margins reported in the Q1 of this year. We are exceptionally pleased that our core lung diagnostic sales efforts continue to gain momentum during the Q2 As the number of tests delivered reached the highest in company history for the 2nd consecutive quarter, increasing by 75% compared to the Q2 of 2022 and nearly matching the 78% year over year growth we saw in the Q1. The test volumes also represent a 29% sequential increase over the Q1 of 2023. This strong growth continues to be primarily driven by our Notify Lung testing volumes. Our sales team continues to benefit from regular interaction with physicians and care teams, and we are actively participating and an increasing number of peer to peer physician educational events. Speaker 200:07:20It is worth noting that the positive momentum we witnessed throughout the second quarter has carried over into the start of the Q3, further reinforcing our satisfaction with the team's progress and performance. To further support our clinical adoption and reimbursement, we were pleased to have recently shared several updates on clinical studies that build upon and support the clinical utility of our Notify Lung and IQ Lung testing strategies. In May, we presented original data in 4 separate poster presentations at the International Society For Pharmaceutical and Outcomes Research conference, providing evidence of the health economic benefit of the Notify CDT and Notify XL2 test in the management of pulmonary nodules. Most recently in July, we were thrilled to share data from the prospective real world ORACLE study, An observational registry study to evaluate the performance of the NOTIFY XL2 test. It is important to remember that demonstrating clinical utility Is a critical step necessary to drive adoption of any diagnostic test and we're excited that the ORACLE study successfully achieved its primary endpoint demonstrating a 74% reduction in unnecessary invasive procedures. Speaker 200:08:42Overall, the findings from the ORACLE study represent a significant advancement in the clinical evidence for use of the NOTIFY XL2 test in nodule management. In addition to the Oracle publication, Physicians from Beth Israel Deaconess, Tulane University and Einstein Medical Center published an independent third party Multi center study demonstrating that the use of the NOTIFY XL2 test resulted in a 73% reduction in the number of unnecessary invasive procedures conducted on benign nodules as compared to the control arm. Looking ahead, we anticipate sharing additional data and updates on other studies, including our Incyte study assessing the clinical effectiveness of Verastat, our proprietary blood based proteomic immune profiling test At the upcoming International Association For the Study of Lung Cancer World Conference on Lung Cancer being held in Singapore in September and additional abstracts at the annual CHEST meeting being held in Hawaii in October. In addition to the growth in volumes driven by our sales team, Broadening reimbursement coverage remains an important part of our growth strategy. In July, the BioDessics Notify CDT test Was awarded Advanced Diagnostic Laboratory Test or ADLT status by the Center For Medicare and Medicaid Services. Speaker 200:10:09Receiving ADLT status is a major milestone for the BioDosix team as this status is reserved for innovative tests with Medicare coverage that provide clinical value and new diagnostic information that cannot be obtained from any other test or combination of tests, recognizing the unique utility of the Notify CDT test. Now, BioDeskix has 3 tests, Notify CDT, Notify XL2 and Verastrat, all with ADLT status. We'll continue to expand and build upon our reimbursement coverage and expect to have additional updates in the second half of the year. Moving on to our biopharmaceutical partnerships and services business. In the second quarter, We reported revenue of $423,000 which grew slightly over the Q1, but it's still an area that continues to be impacted by delayed enrollment in clinical trials. Speaker 200:11:06We remain bullish on the biopharmaceutical partnership and service business as we continue to have a strong backlog and incoming requests for proposals. And we ended the quarter with $9,300,000 under contract, but not yet recognized. While we're encouraged by the continued strength in the backlog, we assume the challenges our biopharma partners are experiencing will remain for the next few quarters as projects slow and in some cases are delayed beyond the originally expected timelines. I've emphasized this point before and cannot stress it enough. 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 3 deadliest cancers, breast, prostate and colon cancer. Speaker 200:11:55Time is of the essence when it comes to diagnosing and treating these patients. At biodessics, we take great pride in our capability and capacity to healthcare professionals and care teams swiftly. We strive to offer the best testing turnaround times in the industry for all our tests with the goal of improving patient outcomes. Our company and team experienced a strong quarter and first half of the year. We maintain confidence in our ability to sustain this momentum, driving continued growth in test volumes and revenue throughout the second half of the year and beyond. Speaker 200:12:39Now let me turn it over to Robin to review the Q2 2023 financial performance. Robin? Speaker 300:12:46Thanks, Scott. 2nd quarter total revenue was $11,900,000 an 8% increase over the prior year, including COVID revenue and a 48% increase over the prior year excluding COVID revenue of $3,000,000 from COVID testing volumes in the Q2 of 2022. Core lung diagnostic revenue in the Q2 was $11,400,000 compared to $7,300,000 for the Q2 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 Q2 of 2022, a 75% increase. The test volume growth was primarily driven by our Notify nodule management lung testing, which includes Notify XL2 and Notify CDT. Speaker 300:13:39The difference in growth rates between volumes and revenue was primarily driven by the timing of Medicare coverage for Notify CDT achieved in the Q2 of 2022. Biopharmaceutical Services revenue was $423,000 in the quarter compared to $744,000 in the Q2 of 2022 And $411,000 in the Q1 of 2023, a decrease of 43% compared to the Q2 of 20 22 and an increase of 3% over the Q1 of 2020. 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 Q2 of 2023 with $9,300,000 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. Speaker 300:14:39Gross margin percentage in the Q2 2023 was 73% versus 64% in the prior year quarter and 65% in the Q1 of 2023. Current gross margin trends reflect the growth in our higher Gross Margin Lung Diagnostic Testing Business, successful completion of projects to decrease costs and optimize testing workflows And cessation of commercial COVID testing. This margin achievement is ahead of plan and we anticipate maintaining margins in the low 70s going forward. Overall operating expense, excluding direct costs and expenses, was $19,600,000 in the Q2 of 2023 compared to $6,000,000 for the same period of 2022 $22,300,000 in the Q1 of 2023. The increase versus last year is primarily from increased sales and marketing expense from increased travel related costs due to the return to pre pandemic level access to physicians and increases in other non employee related costs. Speaker 300:15:42The decrease as compared to the Q1 is related to the realization of savings from our Prioritization of projects that are expected to result in near term revenue and the delay of longer term projects. Operating expense for the Q2 2023 includes $1,100,000 in non cash stock compensation expense as compared to $1,400,000 during the Q2 2022 $2,300,000 in the Q1 of 2023. Net loss for the Q2 2023 was $13,400,000 compared to a $15,800,000 net loss for the same period of 2022 and $18,700,000 for the Q1 of 2023, driven partially by the improvements in gross margin and operating expenses. The decrease in net loss for the quarter included a decrease in non cash stock based compensation and the absence of a onetime loss on extinguishment In the year ago quarter of $3,000,000 resulting from the restructuring of the contingent consideration agreement with Integrated Diagnostics, offset by an increase in interest expense primarily associated with the Perceptive Term loan facility. If we remove the 800 dollars 1,000 from depreciation and amortization, dollars 1,100,000 from stock based compensation and $2,400,000 in interest expense. Speaker 300:17:01The loss for the Q2 was $9,100,000 as compared to $13,200,000 when making the comparable adjustments to Q1 of 2023, a decrease of 31%. We ended the quarter with $17,400,000 in unrestricted cash and cash equivalents as compared to $25,300,000 in unrestricted cash and cash equivalents at the end of the Q1, a decrease of $7,900,000 which included the scheduled milestone payment of $2,300,000 paid in April 2023 to Integrated Diagnostics, Change in working capital and also includes $5,800,000 in tenant improvement dollars offset by $6,200,000 in investment in the new facility. The cash burn decreased from $17,800,000 in the Q1 of 2023 as a result of our commitment to a cost disciplined approach in growing the business. The cash balance as of June 30, 2023 does not include the $27,500,000 raised in the private placement previously discussed, which was completed subsequent to quarter end. In the upcoming Q4, we expect to move into our new state of the art facility in Louisville, Colorado, just down the road from our current Boulder location. Speaker 300:18:15The new facility has improved capacity for lung diagnostic testing, Biopharmaceutical Services Testing and Collection Kit Manufacturing, which we brought in house in 2022. During the construction of the new facility, Materials and equipment were incorporated to optimize energy efficiency and reduce emissions, advancing some of our longer term ESG goals. We remain focused on 2 major goals, growing our revenue by helping more physicians treat more patients than ever before and making sequential progress on our path to profitability. 2nd quarter results showed our progress and success towards both of those goals, And we are maintaining the guidance provided earlier this year of full year 2023 revenue of $52,000,000 to 55,000,000 Our guidance assumes continued strong year over year growth in our core lung diagnostic testing business, broader reimbursement of our 5 on market tests, as well as modest expected growth in our biopharmaceutical services business. Now let me turn it back to Scott. Speaker 300:19:18Scott? Speaker 200:19:19Thanks, Robin. In closing, I want to express my gratitude to all the incredible members of the BioDessics 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 loan focused sales team, who've 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. Speaker 200:20:08Additionally, 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 BioDessics team for your invaluable contributions to our success. Speaker 200:20:55Together, We're making a real difference and positively impacting physicians and the patients they treat. Robin, the BioDeskix team and I Are as excited as we've ever been about the future of biodesics and the opportunities that lie ahead. With that, I'll turn the call over to the operator for questions. Operator00:21:16Thank you. We will now conduct a question and answer session. Our first question comes from the line of Andrew Brackman. Your line is now open. Speaker 400:21:53Hey, everyone. This is Maggie Buie 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. Speaker 400:22:05Can you talk about kind of the pacing for the 3rd Q4 within these assumptions, maybe both on the core lung diagnostic side and then the biopharma services side? And then the biopharma services side? Speaker 300:22:17Yes. 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 Q3 and then further step up in the 4th. Speaker 300:22:38With our biopharma services, that one is the one that is More difficult to predict. It's very lumpy. We've seen great interest Coming into the company, more requests 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. Speaker 400:23:23Got it. That makes sense. And maybe just one on volume growth on that core lung side. So you've now had 2 really strong quarters of growth in a row. Can you maybe Break apart that growth and talk about how much of it's being driven by greater existing account utilization or even new account utilization or any other drivers here? Speaker 400:23:42Thank you. Speaker 500:23:44Yes. Speaker 200:23:44Thank you, Maggie. This is Scott. Appreciate the question. Yes, as we've stated before, we've Had and experienced great interest in adoption really across all pulmonology groups, which also includes kind of community, rural And academic. So we continue to see growth across all segments. Speaker 200:24:05We think that the Oracle publication will continue to increase that. 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. Speaker 400:24:37Great. Thanks so much. Speaker 200:24:39Thank you, Maggie. Operator00:24:41Thank you. Please standby for our next question. Thank you. Our next question comes from the line of Kyle Nixon of Canaccord Genuity. Your line is now open. Speaker 500:25:02Great. Hey, guys. Thanks for taking the questions. Congrats on the quarter. So similar line of thoughts, this took the 75% growth year over year for test volume. Speaker 500:25:11I guess, like, could you like just parse out how much of that, Scott, is from recurring sort of like Among clinicians and reordering, I think that's like an interesting dynamic that this is like such outsize 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 years. So I'd be if you could just double click on that, it'd be kind of good to hear. Speaker 200:25:34Yes. Thanks, Kyle. Appreciate the question. We haven't disclosed that metric. Obviously, we track that closely. Speaker 200:25:41What 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 begins ordering the test and applying those test results, at what point in time do they become sticky? Speaker 200:26:26And so We really, we expect to get into that 10 to 20 test 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 result 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. Speaker 500:27:10Okay. That was great, Scott. And the 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 Verastat, Janusrat, the Can you talk about like the competitive dynamics that are happening in that market and maybe like your penetration and how that has been progressing because we don't really hear about it as much on these calls? Speaker 200:27:31Yes. No, it's a good point. The IQ lung portion of our test, which includes Verastat, Genostrat NGS and Genostrat DD PCR. The Genostrat 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. Speaker 200:27:55I 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 More recently, and we felt like that complemented the ddPCR test. We are the only company out there offering both In that clinical setting. Speaker 200:28:26But 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 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. Speaker 500:29:04Perfect. And on the gross margin, this is great to see the 73% low 70s already kind of approaching mid-70s. 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 bio Pharma revenue is going to impact gross margins going forward too. Speaker 500:29:25I know it's probably somewhat uncertain and hard to predict, but I was just curious if you guys could just comment on that. Speaker 200:29:30Yes. It's a great question and I think you kind of answered it. It is uncertain because we did state that we've got $9,300,000 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. Speaker 200:29:55Now 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. Speaker 500:30:10Awesome. And then just a final one for me. Rob, you talked about the you guys are moving into a new facility. Is there any CapEx implications from that or is it already kind of built out and everything? Speaker 300:30:21Yes, there is. So we have still have some tenant improvement dollars that we Expect to exhaust here in the Q3 and then there'll be some CapEx in Q3 Q4. We move towards the end of the well, at the end of the year, and we'll 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 expect to see sort of the consistent CapEx in 3rd and 4th quarter like we've seen in 1st and second. Speaker 500:31:05So there wouldn't be like a step up temporarily? Speaker 300:31:11No step up in the amount of CapEx, but step down in the tenant improvement dollars that come in. So we'll exhaust that here in the 3rd Operator00:31:45Our last question comes from the line of Tejas Savant of Morgan Stanley. Your line is now open. Speaker 600:31:53Hello. 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 in prospective clinical trial enrollment and sample delivery has trended over the And also could you provide a degree of customer concentration for the $9,300,000 under contract? Speaker 200:32:18Hi, Hugo. 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 pickup. 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. Speaker 200:32:52And so we feel like there is movement and progress there, and that's encouraging for us. We've also seen a record number of requests 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 $9,300,000 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. Speaker 200:33:25And 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 Their own development and research. So we feel like we're fairly balanced. We're also balanced I 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. Speaker 200:34:11Is that helpful, Yuko? Speaker 600:34:12Yes, that was great. Thank you so much, Scott. Also with the upcoming chess conference, what presentation and presence do you anticipate to have there since 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 CHAS? Speaker 200:34:31Yes. 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 November. This year's meeting has been pulled up, so it's early October. Speaker 200:34:53We'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. Speaker 200:35:37And 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. Speaker 600:35:49No, no, no. Go ahead. Speaker 200:35:52Yes. 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 enrollment. So, I don't expect to have interim Data analysis that we'd be sharing at CHEST because we would already be doing that analysis. Speaker 200:36:18I 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 prospective randomized trial in this space is significant. We're excited to get that data out there. And we're really proud to be working with the number of major academic institutions that we are on that study. Speaker 600:36:48Great. Thank you so much for the color. Speaker 200:36:51Yes. Thank you, Yuko. Operator00:36:54Thank 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 BioDeskix for closing remarks. Speaker 200:37:07Thank you, operator. We 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 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 result delivery. We've prioritized a quality focused Biodesic's team and culture And trust that our cost discipline approach and resultant reduction in operating expense and cash burn will provide greater clarity and assurance around our path to profitability. Speaker 200:38:23We 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 artRead morePowered by