NASDAQ:TTOO T2 Biosystems Q2 2024 Earnings Report $0.11 0.00 (0.00%) As of 03:48 PM Eastern Earnings HistoryForecast T2 Biosystems EPS ResultsActual EPS-$0.66Consensus EPS -$0.97Beat/MissBeat by +$0.31One Year Ago EPSN/AT2 Biosystems Revenue ResultsActual Revenue$1.95 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AT2 Biosystems Announcement DetailsQuarterQ2 2024Date7/29/2024TimeAfter Market ClosesConference Call DateMonday, July 29, 2024Conference Call Time4:30PM ETUpcoming EarningsT2 Biosystems' Q4 2024 earnings is scheduled for Thursday, April 24, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by T2 Biosystems Q2 2024 Earnings Call TranscriptProvided by QuartrJuly 29, 2024 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:00Greetings and welcome to T2 Biosystems Inc. 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. Operator00:00:22I will now turn the conference over to your host, Tripp Taylor, Investor Relations at T2. You may begin. Speaker 100:00:29Thank you, operator. I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements. Those include statements related to T2 Biosystems' future financial and operating results and plans for developing and marketing new products. Forward looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in T2 Biosystems' annual report on Form 10 ks filed with the SEC on April 1, 2024, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward looking statements except as required by law. Speaker 100:01:17With that, I would like to turn the call over to Chairman and CEO, John Sperzel. John? Speaker 200:01:24Thank you all for joining our Q2 2024 results call. Speaker 300:01:29Today, I Speaker 200:01:29will start by discussing the July 2024 health alerts issued by multiple U. S. Government agencies, informing healthcare providers that Becton Dickinson or BD is unable to supply sufficient quantities of blood culture media bottles, which has the potential to favorably impact our sepsis revenue. I will then provide a brief update on our 3 corporate priorities before turning the call over to John Sprague, our Chief Financial Officer, who will review our financial results. I will then provide closing remarks and open the call for questions and answers. Speaker 200:02:06On July 10, 2024, the U. S. Food and Drug Administration, or FDA issued an alert to inform healthcare providers of interruptions in the supply of BD Bactech blood culture media bottles because of recent supplier issues and added blood culture media bottles to the medical device shortages list. According to the FDA alert, The disruption in supply of this device is expected to impact patient diagnosis, follow-up patient management and antimicrobial stewardship efforts. On July 23, 2024, the U. Speaker 200:02:44S. Centers For Disease Control and Prevention, or CDC, issued a health alert network to inform healthcare providers, laboratory professionals, healthcare facility administrators and state, tribal, local and territorial health departments of a critical shortage of BD Back Tech Blood Culture Media Bottles. The CDC alert included a link informing that the BD Back Tech Blood Culture Media Bottles had an estimated shortage duration through Q4 2024. This is very important as the current guidelines for treating patients with a bloodstream infection or sepsis referred to as the CEP-one bundle specify a collection of blood cultures before the initiation of empirical treatment with broad spectrum antibiotics or antifungals. As such, blood culture is one of the most widely used diagnostic tests in U. Speaker 200:03:39S. Hospitals with an estimated 58,000,000 tests run each year. According to the CDC, most blood cultures in the United States are performed using continuous monitoring blood culture systems and the BD continuous monitoring blood culture system is used in about half of all U. S. Laboratories and is only compatible with BD Backtech Blood Culture Media Bottles. Speaker 200:04:05T2 Biosystems is focused on sepsis and I will remind everyone that sepsis continues to exact an enormous human and economic toll. Sepsis is the leading cause of death in U. S. Hospitals and claims the lives of approximately 350,000 Americans annually. Sepsis also represents the leading cost of hospitalization in the U. Speaker 200:04:28S, fussing our healthcare system an estimated $62,000,000,000 annually. Lastly, sepsis is the leading cause of 30 day hospital readmission in the United States. With 19% of sepsis survivors rehospitalized within 30 days and 40% within 90 days. On previous earnings calls, I have described the limitations of relying on blood culture as a clinical specimen for patients at risk of sepsis, including poor sensitivity that is false negative results or missed infections and slow time to result that is 1 to 5 days. Despite these shortcomings, blood culture remains as the standard of care for patients at risk of sepsis. Speaker 200:05:16And except for T2 Biosystems sepsis products, all other FDA cleared products authorized for pathogen detection or antibiotic resistance testing require a positive blood culture as the clinical specimen. These blood culture dependent diagnostic products, which include virtually all of our competitors, provide little to no clinical value if blood culture yields a false negative result due to poor sensitivity or if blood culture is not available due to supplier issues. The blood culture supply interruption underscores the risk of creating guidelines based on a single diagnostic technology that is blood culture. We believe this is the perfect time to lobby for changes to the guidelines to include diagnostic products that are able to detect sepsis causing pathogens and antibiotic resistance genes directly from blood and independent of blood culture. As a reminder, T2 Biosystems developed and is commercializing the only FDA cleared diagnostics able to detect sepsis causing pathogens directly from whole blood without the need to wait days for a positive blood culture. Speaker 200:06:33Combination of our FDA cleared T2Dx instrument, T2Bacteria Panel and T2Candida Panel can detect sepsis causing bacterial and fungal pathogens in 3 to 5 hours directly from blood. No other company in the world can make that claim. As part of the communication, both the FDA and CDC have recommended that healthcare providers develop strategies to minimize the use of blood culture media bottles. Our products can be effectively used to minimize the use of blood culture bottles, especially during this critical shortage and can also provide results for the most common pathogens much faster than blood culture, which can lead to faster targeted antimicrobial treatment. It's important to note that our expanded T2Bacteria Panel, which now includes the detection of Acinetobacter baumannii covers approximately 75% of all sepsis causing bacterial pathogens commonly found in bloodstream infections. Speaker 200:07:35Likewise, our T2Candida Panel covers approximately 90% of Candida species commonly found in bloodstream infections. Now turning to review the significant progress we have made across our 3 corporate priorities, accelerating our sales, enhancing our operations and advancing our pipeline. Starting with our 1st corporate priority, accelerating our sales. The T2 Biosystems team achieved record quarterly and first half sepsis test revenue, representing growth of 27% and 25%, respectively, compared to the prior year periods. This double digit sales growth was driven by sales of our T2Bacteria Panel and our T2Resistance Panel. Speaker 200:08:22During the Q2, we executed contracts for 2 T2Dx instruments in international markets and ended the quarter with a number of opportunities deep in our sales funnel. As expected, we have already executed contracts for an additional 6 T2Dx instruments in July of 2024 valued at approximately $400,000 In the U. S. Market, our commercial team continues to prioritize increasing sales of our sepsis test panels. We believe the BD blood culture media bottle shortage represents an opportunity for T2 Biosystems to increase adoption of our direct from blood or blood culture independent diagnostics and our team is implementing a plan to proactively contact hospital microbiology departments. Speaker 200:09:13Over the last 12 months, we have been exploring a range of strategic alternatives, including U. S. Commercial partnerships to accelerate the growth of our business. I'm pleased to inform you that we are in negotiations with a multibillion dollar healthcare company regarding a potential U. S. Speaker 200:09:31Commercial partnership for the distribution of our products. In international markets, we continue to execute on our plan to expand our commercial footprint by entering into territory exclusive distribution agreements to market and sell the T2Dx instrument, the T2Bacteria Panel, the T2Candida Panel and the T2Resistance Panel. During the Q2, we entered into new territory exclusive distribution agreements covering Qatar, Hong Kong and Macau. Earlier today, we announced a new territory exclusive distribution agreement covering Malaysia and Indonesia. The execution of these distribution agreements further expands our commercial footprint in the Asia Pacific and Middle East regions, which we believe represents strong growth potential for our blood culture independent rapid diagnostics. Speaker 200:10:25The introduction of the T2Dx instrument and sepsis panels into Hong Kong, Macau, Malaysia, Indonesia and Qatar will allow rapid detection of certain sepsis causing pathogens and antibiotic resistance genes in hours instead of days, enabling clinicians to potentially achieve faster targeted therapy. We look forward to building lasting relationships with our newly appointed distributors. Our sepsis products continue to generate data further validating the value we can deliver to hospital microbiology labs to improve patient care. In May, T2 Biosystems customers presented new clinical data to support the T2Candida Panel at the American Society For Microbiology ASM Microbe 2024 Conference in Atlanta. The first presentation at ASM demonstrated how the use of the T2Candida Panel led to improved patient care for patients suspected of candidemia at Henry Ford Hospital. Speaker 200:11:27The findings highlighted the T2Candida Panel results being available over 38 hours faster than beta D glucan tests and the detection of over 3 times as many infections as blood culture. The evidence further supports the improved clinical outcomes that can be achieved with the T2Candida Panel in the diagnosis and management of candidemia at a large urban academic center. 2nd presentation at ASM demonstrated clinical outcome data for patients admitted to an ICU at Henry Ford Hospital that utilized the T2Candida Panel compared to a control hospital using only the blood culture standard of care. Analysis revealed that more patients diagnosed with the T2Candida Panel were alive without any events and had a 58.6 probability of achieving a better outcome compared to conventional blood culture testing. There was also less incidence of treatment failures, persistent candidemia and infection confiscations in patients who were diagnosed via the T2Candida Panel compared to conventional testing. Speaker 200:12:37Overall, the presentation highlighted that the use of T2Candida Panel with an antifungal stewardship policy was associated with an overall medical clinical outcome compared to diagnosis with blood culture. Beyond sepsis, we're also applying our technology to 2 additional areas, bioterrorism and Lyme disease. We believe these additional applications have the potential to be significant growth catalysts for the company. On the T2 Biothreat panel, we've entered into an agreement with Doctor. Robin Robinson to serve as a strategic advisor. Speaker 200:13:14He's currently fielding interest in identifying strong potential government targets to procure the T2 Biothreat Panel. We believe the panel represents a strong market opportunity and has the important ability to protect our nation from the consequences of deliberate or accidental exposure to biothreats. We plan to launch our T2 line panel as a laboratory developed test or LDT during the Q3 of 2024 through a strategic partnership with Ecolaboratory. We believe there are numerous advantages of launching the T2Lyme Panel in this format, including faster time to market, higher test throughput and stronger product contribution margins as the LDT format does not require the use of the T2Dx instrument or the costs associated with a cartridge. Internal market research confirms that reference laboratories often charge greater than $2.50 for 2 tiered antibody Lyme tests and greater than $2.50 for PCR Lyme tests. Speaker 200:14:20It's important to note that sales of the T2 BioThreat Panel and T2Lyme Panel are not in our current 2024 revenue guidance. So potential sales during 2024 represent upside to that guidance. Moving to our 2nd corporate priority, enhancing our operations. We continue to take important steps to transform our balance sheet and improve our cost structure. Over the past 12 months, we have reduced our debt by approximately 80% by converting $40,000,000 of our term loan with entities affiliated with CRG Servicing LLC or CRG to common stock. Speaker 200:15:00This has significantly strengthened our balance sheet and reduced our annual interest payments by approximately $3,200,000 During the second half of twenty twenty four, we plan to further consolidate our real estate space by exiting our facility at 4 Hartwell Avenue in Lexington, Massachusetts and consolidating those operations into our headquarters at 101 Hartwell Avenue in Lexington, Massachusetts. We expect this move to reduce our facility costs by approximately $1,000,000 annually. Effective August 1, 2024, we are partnering with ADP TotalSource as our Professional Employer Organization or PEO to provide comprehensive and cost effective HR benefits, including healthcare benefits, workers' compensation, payroll and tax support and HR guidance. We estimate this change will result in annualized savings of approximately $400,000 Since early 2023, we have reduced our headcount by approximately 30% to 113 employees. At the same time, we have reduced employee related operating expenses. Speaker 200:16:18Finally, during the Q2, we expanded the use of our Oracle ERP system to improve inventory planning and material management. We believe the Oracle ERP expansion will favorably impact inventory levels, cost of goods sold and ultimately improve cash flow. Moving to our 3rd corporate priority, advancing our pipeline. We have 3 tests in our pipeline, including the U. S. Speaker 200:16:44T2Resistance Panel, the T2Lyme Panel and the expanded T2Candida Panel to include detection of Candida auris. These three tests or test panels have each received FDA breakthrough device designation and each share a critical requirement for rapid detection of the causative pathogen and targeted antimicrobial treatment. The U. S. T2Resistance Panel is a direct from blood molecular diagnostic test that runs on the FDA cleared T2Dx instrument and simultaneously detects 13 antibiotic resistance genes in just 3 to 5 hours without the need to wait days for a positive blood culture. Speaker 200:17:27We believe the T2Resistance Panel will be a significant catalyst to drive broader adoption of our T2Dx instrument and our T2Bacteria Panel. In March, we issued a press release to announce the results of a new prospective study that was published in the Journal of Clinical Microbiology, highlighting the performance and clinical benefits of the T2Resistance Panel compared to blood culture and standard microbiology methods, including high accuracy, that is 94.7 percent sensitivity and 97.4 percent specificity. Rapid turnaround time, that is results available in 4.4 hours compared to 58.3 hours and clinical impact that is clinical interventions in 41% of the patients in the study, 24 of 59 patients. We believe this performance data represents the enormous potential of this unique and highly differentiated product to reduce cost, improve patient outcomes and reduce the threat of antibiotic resistance. We expect this to be a catalyst for greater adoption of the teacher resistance panels in countries where we currently market under a CE mark. Speaker 200:18:42We also believe the international experience with the direct from blood or culture independent detection of antibiotic resistance genes is an important precursor to our launch in the U. S. Market. Due to our priority to provide products for our existing customers, our internal verification and validation studies were slightly delayed. As a result, we now plan to submit a 510 premarket notification to the U. Speaker 200:19:09S. Food and Drug Administration or FDA during the Q4 of 2024. And we expect to receive a prioritized FDA review due to its breakthrough device designation. The T2Lyme Panel is a direct from blood molecular diagnostic test designed for the early detection of Borrelia burgdorferi, the bacterium that causes Lyme disease in the United States. Lyme disease is the leading vector borne disease in America with an estimated 3,400,000 tests performed each year. Speaker 200:19:43The current diagnostic product is a 2 tiered antibody test algorithm that relies on the presence of antibodies and can only be used accurately 4 to 8 weeks after infection. If left untreated, the bacteria may spread throughout the body and become much harder to eradicate and treat effectively. Although early symptoms of Lyme disease are similar to the flu, reliobordorferi infections can lead to chronic debilitating disease. To address this critical unmet need, we've developed an extremely sensitive diagnostic test for the detection of early Lyme disease with an analytical sensitivity that is in line with our FDA cleared sepsis tests. We've recently completed clinical studies required to launch the T2Lyme Panel as a lab developed test. Speaker 200:20:33We believe our test will detect Lyme disease within the 1st 30 days post infection compared to antibody tests that can take 30 to 60 days post infection. As I mentioned earlier on the call, we plan on the T2Lyme Panel as an LDT in the Q3 of 2024 through a strategic partnership with Ecolaboratory. Our ultimate objective is to provide early Lyme disease results to major U. S. Reference laboratories. Speaker 200:21:02We believe we can utilize their retail networks to collect patient samples, which would potentially allow us to provide testing to Lyme patients across the country. These samples would then be sent to our LDT laboratory partner to perform the T2Lyme Panel in their lab. Again, it's important to note that T2 line panel sales are not in our current 2024 guidance. So any potential sales during 2024 represent upside to that guidance. The expanded T2Candida Panel, which will include the detection of Candida auris is a direct from blood molecular diagnostic test designed to detect Candida species in just 3 to 5 hours without the need to wait days for a positive blood culture. Speaker 200:21:46We believe the addition of Candida auris test will strengthen the value proposition of our T2Candida panel and lead to increased adoption. Candida auris is a multi drug resistant fungal pathogen that has a mortality rate of up to 60% and is recognized as a serious global health threat by the CDC and the World Health Organization. The CDC estimates the costs associated with U. S. Fungal diseases are as high as $48,000,000,000 annually and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the life saving benefits of early detection and proper treatment. Speaker 200:22:27A 2022 Journal of Clinical Microbiology study conducted at the Bambino Gizhou Hospital in Rome, Italy found that pediatric patients suspected of fungal bloodstream infections that were tested with the T2Candida Panel received species identification results 121.8 hours faster compared to blood culture based diagnostics. Finally, we're also pursuing expanded claims for our FDA cleared T2Candida Panel and T2Bacteria Panel to include pediatric testing. In December 2023, we submitted a 510 premarket notification to the FDA to expand the use of the T2Candida Panel to include pediatric testing. And we expect to submit a 510 premarket notification to the FDA to expand the use of the T2Bacteria Panel to include pediatric testing during 2024. With that, I'll now turn the call over to John Sprague to provide a detailed update on our Q1 financial results. Speaker 400:23:29Thank you, John. 2nd quarter 2024 revenues were $2,000,000 all from sepsis product sales. Sepsis test panel sales increased 27% compared to the prior year period and increased 12% compared to the Q1 of 2024 led by increased sepsis test sales offset by lower international instrument sales. 2nd quarter 2024 cost of product revenues were $2,700,000 a 45% increase decrease, excuse me, compared to the prior year period, driven by increased sepsis test sales and lower international instrument sales. Research and development expenses were $3,400,000 a 13% decrease compared to the prior year period, driven by decreased trial activities. Speaker 400:24:19Selling, general and administrative expenses were $5,500,000 a 13% decrease compared to the prior year period, driven by decreased headcount spending. The Q2 2024 net loss was $9,200,000 $0.66 per share compared to the prior year's 2nd quarter net loss of $6,300,000 $7.84 per share. Cash and cash equivalents were $4,200,000 as of June 30, 2024 and we raised $7,300,000 in net proceeds from a private placement stock sale in the quarter. The CRG debt conversion reduced our debt by almost 80% and interest expense by almost 70% compared to a year ago. In 2024, we continue to expect total sepsis and related products revenues to grow between 49% 64% to $10,000,000 to $11,000,000 over 2023 and this target excludes any potential sales from our T2 BioThreat or T2Lyme panels. Speaker 400:25:25Thank you and back to John Sperzel for closing remarks. Speaker 200:25:32We are highly encouraged by the progress made in the Q2 of 2024, including record sepsis test sales, significantly improving our balance sheet, materially improving our cost of product revenue and reducing our operating expenses. Moving forward, we're excited by the potential to accelerate the growth of our sepsis business in the United States and internationally. We're also excited by the potential near term catalysts, including the opportunity created by the B blood culture media bottle shortage, the U. S. Commercial launch of our T2Lyme Panel for the detection of early Lyme disease planned for the Q3 of 2024 and the potential to establish a U. Speaker 200:26:16S. Commercial partnership for the distribution of our products with a multibillion dollar healthcare company. Our pipeline is also rich with potential catalysts that have already received FDA breakthrough device designation, including the U. S. T2Resistance Panel, which we plan to submit to the FDA for 510 clearance during the Q4 of 2024 and the expanded T2Candida Panel to include the detection of Candida auris. Speaker 200:26:44With that, I'd like to turn the call back over to the operator to open the line for questions. Operator? Operator00:26:49Thank you. At this time, we will be conducting a question and answer session. The first question is coming from Kyle Mixon from Kennard. Kyle, your line is live. Speaker 300:27:31Hey, guys. Thanks for the questions. So just wanted to talk the second half of the year outlook, what you're expecting there. So whatever you're seeing internationally in terms of like just the pipeline, the deals and orders and when you could place those instruments and also utilization internationally? Like could anything ramp up maybe like towards year end or something? Speaker 300:27:51And obviously, you have guidance for full year, but how should we think about Q3 and Q4, as we kind of go ahead here? And obviously, like there's revenue as a component of that as well as margin. So if you could just maybe parse those out and help us think about that would be great. Speaker 200:28:06Sure, Kyle. So on the last call, I mentioned that the company was at an inflection point. And I continue to believe that, and I also believe that the progress that we made during the Q2 reflects that. To get to your questions, in terms of our guidance, if you look at the guidance that we have given and reiterated both at the beginning of the year and at the end of the first and now the end of the second quarter, we expected somewhere between $10,000,000 $11,000,000 of product revenue, which is in the range of mid-forty percent to mid-fifty percent growth year over year. And it was weighted approximately 40% in the first half of the year and 60% in the back half of the year. Speaker 200:28:52And we continue to believe that, that is the appropriate mix first half versus second half. So we expect a very good second half of twenty twenty four, given all of that that I said. In terms of our international business, it continues to be strong. We continue to expand our distribution network in international markets. We added a number of countries during the Q2. Speaker 200:29:16We expect to add additional territory exclusive distribution agreements in the second half of twenty twenty four. When it comes to instruments, we had 2 instruments in the Q2, which admittedly was lighter than we expected. We had a number that were close to the goal line at the end of June, which essentially rolled over into July. And I referenced in the prepared remarks, we already have 6 instruments sold in international markets, which will generate about $400,000 in Q3. As far as utilization is concerned, it's much more difficult to track utilization in international markets because we're selling through distributors and it's a little more difficult to parse out what product might be in the pipeline and what product is in customers' hands and what product has been used, and it's much easier to track that in the United States. Speaker 200:30:09In the United States, utilization continues to increase, and we continue to believe that all of our U. S. Customers and customers that we have in the future could get to approximately $200,000 of annualized infectious test revenue. Speaker 300:30:27Okay. Thanks for all that. And the partnership with the, I think with like multibillion dollar healthcare company, What are the like the financial implications of that? And when could that kind of come through? Like I'm just, for example, if that's a distributor, could that increase, I guess, like placements and stuff? Speaker 300:30:46Or does that really not have to do with consumable utilization? Or is it something where maybe it's like a partnership that will actually boost pull through basically or something? I'm just trying to think about how that's going to affect the model in years going forward. Speaker 200:31:03So our objective with a U. S. Commercial partner, first of all, is to find the right one, the one that has presence across U. S. Hospitals, that has a physical presence in the locations within the hospital and has scale because one of the things that we lack as a small diagnostic company, particularly in the United States, is commercial scale. Speaker 200:31:26And so we have been working to address that. And we feel confident about the partner that we are negotiating that with. Obviously, confident enough that we would mention it on this call. As far as details about that potential agreement, Kyle, I can't get into that yet. But most certainly, once we have finalized that, that would be something that we would share with the market. Speaker 300:31:53Okay. And some of the studies that yes, sorry, go Speaker 200:31:57ahead. I said we're certainly excited about it. Okay. Speaker 300:32:00And then some of the studies that, I guess were sort of it sounds like a little delayed, maybe some of the submissions were a little delayed. Is there any risk that was get further delayed? And how important was that timing of that? If you look if you kind of think about how the milestone to shape up for you going forward? Or was timing kind of like not the most important thing this year? Speaker 200:32:22Were you talking about T2Resistance, Connor? Speaker 300:32:26Yes. It also sounded like some of the clinical studies maybe were a little bit either delayed or sort of like slower than expected, but I'll let you kind of take that. Speaker 200:32:34Sure. So let me just take the couple of things in our pipeline. T2Lyme, those studies on track, on time and they're completed. The tissue resistant studies were delayed for one reason and that was that we had a manufacturing issue that we had discussed with the market in the back half of twenty twenty three, which we have resolved. But that delay forced us to prioritize where we shipped the product that we actually made, again, for teacher resistance. Speaker 200:33:06And we made the, I'd say, obvious decision to supply our current customers in Europe and not to supply ourselves so we could get those clinical studies done. Or sorry, the internal verification validation studies. So the field clinical studies for T2Resistance are completed. What's left are internal verification validation, and we have resumed those. It did unfortunately push our planned submission to FDA from Q3 of this year to Q4 of this year. Speaker 300:33:38Okay. Got it. That makes sense. And then then just kind of looking at the P and L and SG and A, it remains pretty relatively low compared to like prior year level levels and recent levels. Are you thinking about, I guess, increasing sales force anytime soon or not? Speaker 200:33:59Absolutely not. In fact, we have reduced our sales force, particularly in the United States, not internationally, but we reduced it in the United States because we expected to have a U. S. Commercial partner. And what we have as our U. Speaker 200:34:17S. Sales team are people that we believe can effectively work with the partners that we're engaged with. So we haven't done it by happenstance. It's part of a planned strategy. Speaker 300:34:34Okay. And then just a final question about the balance sheet. Is there anything you could kind of share regarding like moves that you'll maybe make in the second half of the year here just to kind of like shore up the balance sheet and just make sure you have enough entering 25%. You made some moves recently, but the cash position, maybe it's not totally ideal. So maybe just like a little bit of like a preview, I guess, of anything to put in the model for us? Speaker 200:35:05Todd, what I could say about that, we obviously filed an S-three, we put an ATM in place. We obviously want to have the tools available in these markets. We also want to be smart about when we strengthen our balance sheet. We have a whole bunch of catalysts in front of us that I described partly in this Q and A, but also in the prepared remarks that we think are going to be excellent vehicles for us to strengthen our balance sheet around. Speaker 300:35:33Perfect. I'll leave it there. Thanks guys. Appreciate it. Speaker 200:35:36Thank you, Kyle. Speaker 300:35:38Thank you, Kyle. Operator00:35:38Thank you. There were no other questions in the queue at this time. I would now like to hand the call back to John Sperzel for closing remarks. Speaker 200:35:46I would like to say thank you all very much for joining our Q2 2024 earnings call and we look forward to updating you as we progress through the back half of twenty twenty four. Have a great day.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallT2 Biosystems Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) T2 Biosystems Earnings HeadlinesStockNews.com Begins Coverage on T2 Biosystems (NASDAQ:TTOO)April 21 at 1:17 AM | americanbankingnews.comT2 Biosystems initiates major layoffs, seeks asset saleFebruary 22, 2025 | uk.investing.comIs he more powerful than Trump? Is there anybody more powerful than Donald Trump right now? In a single tariff announcement, he wiped out nearly $5 trillion in wealth from the S&P 500 and $6.4 trillion from the Dow Jones… Not to mention the countless trillions of dollars lost in every market around the world… leaving the major political powers scrambling in fear of Trump’s next move.April 24, 2025 | Porter & Company (Ad)Medical diagnostics firm T2 Biosystems cuts ‘substantially all’ workersFebruary 18, 2025 | bizjournals.comT2 Biosystems to be delisted from NasdaqFebruary 11, 2025 | msn.comT2 Biosystems stock plunges to 52-week low of $0.22January 30, 2025 | msn.comSee More T2 Biosystems Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like T2 Biosystems? Sign up for Earnings360's daily newsletter to receive timely earnings updates on T2 Biosystems and other key companies, straight to your email. Email Address About T2 BiosystemsT2 Biosystems (NASDAQ:TTOO), an in vitro diagnostics company, develops and sells diagnostic products and product candidates in the United States and internationally. Its technology enables detection of pathogens, biomarkers, and other abnormalities in various unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum, cerebral spinal fluid, and urine. The company also offers T2Dx Instrument, a bench-top instrument that runs various diagnostic tests from patient samples; T2Candida panel, a direct-from-blood molecular diagnostic test panel that detects lethal form of common blood stream infections, which cause sepsis and candidemia; T2Bacteria panel, a direct-from-blood molecular diagnostic test panel, which detects bacterial pathogens in blood stream infections; T2Resistance panel, a direct-from-blood test that identifies carbapenem resistance genes; and T2Biothreat, a direct-from-blood molecular diagnostic test panel that runs on the T2Dx Instrument and detects biothreat pathogens. In addition, it is developing T2Cauris panel, a direct-from-blood molecular diagnostic test that runs on the T2Dx Instrument and detects Candida auris; and T2Lyme panel, a direct-from-blood molecular diagnostic test panel that runs on the T2Dx Instrument to identify the bacteria that cause Lyme disease. T2 Biosystems, Inc. was incorporated in 2006 and is headquartered in Lexington, Massachusetts.View T2 Biosystems 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 Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Tesla Earnings Miss, But Musk Refocuses and Bulls ReactQualcomm’s Range Narrows Ahead of Earnings as Bulls Step InWhy It May Be Time to Buy CrowdStrike Stock Heading Into EarningsCan IBM’s Q1 Earnings Spark a Breakout for the Stock? 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There are 5 speakers on the call. Operator00:00:00Greetings and welcome to T2 Biosystems Inc. 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. Operator00:00:22I will now turn the conference over to your host, Tripp Taylor, Investor Relations at T2. You may begin. Speaker 100:00:29Thank you, operator. I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements. Those include statements related to T2 Biosystems' future financial and operating results and plans for developing and marketing new products. Forward looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in T2 Biosystems' annual report on Form 10 ks filed with the SEC on April 1, 2024, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward looking statements except as required by law. Speaker 100:01:17With that, I would like to turn the call over to Chairman and CEO, John Sperzel. John? Speaker 200:01:24Thank you all for joining our Q2 2024 results call. Speaker 300:01:29Today, I Speaker 200:01:29will start by discussing the July 2024 health alerts issued by multiple U. S. Government agencies, informing healthcare providers that Becton Dickinson or BD is unable to supply sufficient quantities of blood culture media bottles, which has the potential to favorably impact our sepsis revenue. I will then provide a brief update on our 3 corporate priorities before turning the call over to John Sprague, our Chief Financial Officer, who will review our financial results. I will then provide closing remarks and open the call for questions and answers. Speaker 200:02:06On July 10, 2024, the U. S. Food and Drug Administration, or FDA issued an alert to inform healthcare providers of interruptions in the supply of BD Bactech blood culture media bottles because of recent supplier issues and added blood culture media bottles to the medical device shortages list. According to the FDA alert, The disruption in supply of this device is expected to impact patient diagnosis, follow-up patient management and antimicrobial stewardship efforts. On July 23, 2024, the U. Speaker 200:02:44S. Centers For Disease Control and Prevention, or CDC, issued a health alert network to inform healthcare providers, laboratory professionals, healthcare facility administrators and state, tribal, local and territorial health departments of a critical shortage of BD Back Tech Blood Culture Media Bottles. The CDC alert included a link informing that the BD Back Tech Blood Culture Media Bottles had an estimated shortage duration through Q4 2024. This is very important as the current guidelines for treating patients with a bloodstream infection or sepsis referred to as the CEP-one bundle specify a collection of blood cultures before the initiation of empirical treatment with broad spectrum antibiotics or antifungals. As such, blood culture is one of the most widely used diagnostic tests in U. Speaker 200:03:39S. Hospitals with an estimated 58,000,000 tests run each year. According to the CDC, most blood cultures in the United States are performed using continuous monitoring blood culture systems and the BD continuous monitoring blood culture system is used in about half of all U. S. Laboratories and is only compatible with BD Backtech Blood Culture Media Bottles. Speaker 200:04:05T2 Biosystems is focused on sepsis and I will remind everyone that sepsis continues to exact an enormous human and economic toll. Sepsis is the leading cause of death in U. S. Hospitals and claims the lives of approximately 350,000 Americans annually. Sepsis also represents the leading cost of hospitalization in the U. Speaker 200:04:28S, fussing our healthcare system an estimated $62,000,000,000 annually. Lastly, sepsis is the leading cause of 30 day hospital readmission in the United States. With 19% of sepsis survivors rehospitalized within 30 days and 40% within 90 days. On previous earnings calls, I have described the limitations of relying on blood culture as a clinical specimen for patients at risk of sepsis, including poor sensitivity that is false negative results or missed infections and slow time to result that is 1 to 5 days. Despite these shortcomings, blood culture remains as the standard of care for patients at risk of sepsis. Speaker 200:05:16And except for T2 Biosystems sepsis products, all other FDA cleared products authorized for pathogen detection or antibiotic resistance testing require a positive blood culture as the clinical specimen. These blood culture dependent diagnostic products, which include virtually all of our competitors, provide little to no clinical value if blood culture yields a false negative result due to poor sensitivity or if blood culture is not available due to supplier issues. The blood culture supply interruption underscores the risk of creating guidelines based on a single diagnostic technology that is blood culture. We believe this is the perfect time to lobby for changes to the guidelines to include diagnostic products that are able to detect sepsis causing pathogens and antibiotic resistance genes directly from blood and independent of blood culture. As a reminder, T2 Biosystems developed and is commercializing the only FDA cleared diagnostics able to detect sepsis causing pathogens directly from whole blood without the need to wait days for a positive blood culture. Speaker 200:06:33Combination of our FDA cleared T2Dx instrument, T2Bacteria Panel and T2Candida Panel can detect sepsis causing bacterial and fungal pathogens in 3 to 5 hours directly from blood. No other company in the world can make that claim. As part of the communication, both the FDA and CDC have recommended that healthcare providers develop strategies to minimize the use of blood culture media bottles. Our products can be effectively used to minimize the use of blood culture bottles, especially during this critical shortage and can also provide results for the most common pathogens much faster than blood culture, which can lead to faster targeted antimicrobial treatment. It's important to note that our expanded T2Bacteria Panel, which now includes the detection of Acinetobacter baumannii covers approximately 75% of all sepsis causing bacterial pathogens commonly found in bloodstream infections. Speaker 200:07:35Likewise, our T2Candida Panel covers approximately 90% of Candida species commonly found in bloodstream infections. Now turning to review the significant progress we have made across our 3 corporate priorities, accelerating our sales, enhancing our operations and advancing our pipeline. Starting with our 1st corporate priority, accelerating our sales. The T2 Biosystems team achieved record quarterly and first half sepsis test revenue, representing growth of 27% and 25%, respectively, compared to the prior year periods. This double digit sales growth was driven by sales of our T2Bacteria Panel and our T2Resistance Panel. Speaker 200:08:22During the Q2, we executed contracts for 2 T2Dx instruments in international markets and ended the quarter with a number of opportunities deep in our sales funnel. As expected, we have already executed contracts for an additional 6 T2Dx instruments in July of 2024 valued at approximately $400,000 In the U. S. Market, our commercial team continues to prioritize increasing sales of our sepsis test panels. We believe the BD blood culture media bottle shortage represents an opportunity for T2 Biosystems to increase adoption of our direct from blood or blood culture independent diagnostics and our team is implementing a plan to proactively contact hospital microbiology departments. Speaker 200:09:13Over the last 12 months, we have been exploring a range of strategic alternatives, including U. S. Commercial partnerships to accelerate the growth of our business. I'm pleased to inform you that we are in negotiations with a multibillion dollar healthcare company regarding a potential U. S. Speaker 200:09:31Commercial partnership for the distribution of our products. In international markets, we continue to execute on our plan to expand our commercial footprint by entering into territory exclusive distribution agreements to market and sell the T2Dx instrument, the T2Bacteria Panel, the T2Candida Panel and the T2Resistance Panel. During the Q2, we entered into new territory exclusive distribution agreements covering Qatar, Hong Kong and Macau. Earlier today, we announced a new territory exclusive distribution agreement covering Malaysia and Indonesia. The execution of these distribution agreements further expands our commercial footprint in the Asia Pacific and Middle East regions, which we believe represents strong growth potential for our blood culture independent rapid diagnostics. Speaker 200:10:25The introduction of the T2Dx instrument and sepsis panels into Hong Kong, Macau, Malaysia, Indonesia and Qatar will allow rapid detection of certain sepsis causing pathogens and antibiotic resistance genes in hours instead of days, enabling clinicians to potentially achieve faster targeted therapy. We look forward to building lasting relationships with our newly appointed distributors. Our sepsis products continue to generate data further validating the value we can deliver to hospital microbiology labs to improve patient care. In May, T2 Biosystems customers presented new clinical data to support the T2Candida Panel at the American Society For Microbiology ASM Microbe 2024 Conference in Atlanta. The first presentation at ASM demonstrated how the use of the T2Candida Panel led to improved patient care for patients suspected of candidemia at Henry Ford Hospital. Speaker 200:11:27The findings highlighted the T2Candida Panel results being available over 38 hours faster than beta D glucan tests and the detection of over 3 times as many infections as blood culture. The evidence further supports the improved clinical outcomes that can be achieved with the T2Candida Panel in the diagnosis and management of candidemia at a large urban academic center. 2nd presentation at ASM demonstrated clinical outcome data for patients admitted to an ICU at Henry Ford Hospital that utilized the T2Candida Panel compared to a control hospital using only the blood culture standard of care. Analysis revealed that more patients diagnosed with the T2Candida Panel were alive without any events and had a 58.6 probability of achieving a better outcome compared to conventional blood culture testing. There was also less incidence of treatment failures, persistent candidemia and infection confiscations in patients who were diagnosed via the T2Candida Panel compared to conventional testing. Speaker 200:12:37Overall, the presentation highlighted that the use of T2Candida Panel with an antifungal stewardship policy was associated with an overall medical clinical outcome compared to diagnosis with blood culture. Beyond sepsis, we're also applying our technology to 2 additional areas, bioterrorism and Lyme disease. We believe these additional applications have the potential to be significant growth catalysts for the company. On the T2 Biothreat panel, we've entered into an agreement with Doctor. Robin Robinson to serve as a strategic advisor. Speaker 200:13:14He's currently fielding interest in identifying strong potential government targets to procure the T2 Biothreat Panel. We believe the panel represents a strong market opportunity and has the important ability to protect our nation from the consequences of deliberate or accidental exposure to biothreats. We plan to launch our T2 line panel as a laboratory developed test or LDT during the Q3 of 2024 through a strategic partnership with Ecolaboratory. We believe there are numerous advantages of launching the T2Lyme Panel in this format, including faster time to market, higher test throughput and stronger product contribution margins as the LDT format does not require the use of the T2Dx instrument or the costs associated with a cartridge. Internal market research confirms that reference laboratories often charge greater than $2.50 for 2 tiered antibody Lyme tests and greater than $2.50 for PCR Lyme tests. Speaker 200:14:20It's important to note that sales of the T2 BioThreat Panel and T2Lyme Panel are not in our current 2024 revenue guidance. So potential sales during 2024 represent upside to that guidance. Moving to our 2nd corporate priority, enhancing our operations. We continue to take important steps to transform our balance sheet and improve our cost structure. Over the past 12 months, we have reduced our debt by approximately 80% by converting $40,000,000 of our term loan with entities affiliated with CRG Servicing LLC or CRG to common stock. Speaker 200:15:00This has significantly strengthened our balance sheet and reduced our annual interest payments by approximately $3,200,000 During the second half of twenty twenty four, we plan to further consolidate our real estate space by exiting our facility at 4 Hartwell Avenue in Lexington, Massachusetts and consolidating those operations into our headquarters at 101 Hartwell Avenue in Lexington, Massachusetts. We expect this move to reduce our facility costs by approximately $1,000,000 annually. Effective August 1, 2024, we are partnering with ADP TotalSource as our Professional Employer Organization or PEO to provide comprehensive and cost effective HR benefits, including healthcare benefits, workers' compensation, payroll and tax support and HR guidance. We estimate this change will result in annualized savings of approximately $400,000 Since early 2023, we have reduced our headcount by approximately 30% to 113 employees. At the same time, we have reduced employee related operating expenses. Speaker 200:16:18Finally, during the Q2, we expanded the use of our Oracle ERP system to improve inventory planning and material management. We believe the Oracle ERP expansion will favorably impact inventory levels, cost of goods sold and ultimately improve cash flow. Moving to our 3rd corporate priority, advancing our pipeline. We have 3 tests in our pipeline, including the U. S. Speaker 200:16:44T2Resistance Panel, the T2Lyme Panel and the expanded T2Candida Panel to include detection of Candida auris. These three tests or test panels have each received FDA breakthrough device designation and each share a critical requirement for rapid detection of the causative pathogen and targeted antimicrobial treatment. The U. S. T2Resistance Panel is a direct from blood molecular diagnostic test that runs on the FDA cleared T2Dx instrument and simultaneously detects 13 antibiotic resistance genes in just 3 to 5 hours without the need to wait days for a positive blood culture. Speaker 200:17:27We believe the T2Resistance Panel will be a significant catalyst to drive broader adoption of our T2Dx instrument and our T2Bacteria Panel. In March, we issued a press release to announce the results of a new prospective study that was published in the Journal of Clinical Microbiology, highlighting the performance and clinical benefits of the T2Resistance Panel compared to blood culture and standard microbiology methods, including high accuracy, that is 94.7 percent sensitivity and 97.4 percent specificity. Rapid turnaround time, that is results available in 4.4 hours compared to 58.3 hours and clinical impact that is clinical interventions in 41% of the patients in the study, 24 of 59 patients. We believe this performance data represents the enormous potential of this unique and highly differentiated product to reduce cost, improve patient outcomes and reduce the threat of antibiotic resistance. We expect this to be a catalyst for greater adoption of the teacher resistance panels in countries where we currently market under a CE mark. Speaker 200:18:42We also believe the international experience with the direct from blood or culture independent detection of antibiotic resistance genes is an important precursor to our launch in the U. S. Market. Due to our priority to provide products for our existing customers, our internal verification and validation studies were slightly delayed. As a result, we now plan to submit a 510 premarket notification to the U. Speaker 200:19:09S. Food and Drug Administration or FDA during the Q4 of 2024. And we expect to receive a prioritized FDA review due to its breakthrough device designation. The T2Lyme Panel is a direct from blood molecular diagnostic test designed for the early detection of Borrelia burgdorferi, the bacterium that causes Lyme disease in the United States. Lyme disease is the leading vector borne disease in America with an estimated 3,400,000 tests performed each year. Speaker 200:19:43The current diagnostic product is a 2 tiered antibody test algorithm that relies on the presence of antibodies and can only be used accurately 4 to 8 weeks after infection. If left untreated, the bacteria may spread throughout the body and become much harder to eradicate and treat effectively. Although early symptoms of Lyme disease are similar to the flu, reliobordorferi infections can lead to chronic debilitating disease. To address this critical unmet need, we've developed an extremely sensitive diagnostic test for the detection of early Lyme disease with an analytical sensitivity that is in line with our FDA cleared sepsis tests. We've recently completed clinical studies required to launch the T2Lyme Panel as a lab developed test. Speaker 200:20:33We believe our test will detect Lyme disease within the 1st 30 days post infection compared to antibody tests that can take 30 to 60 days post infection. As I mentioned earlier on the call, we plan on the T2Lyme Panel as an LDT in the Q3 of 2024 through a strategic partnership with Ecolaboratory. Our ultimate objective is to provide early Lyme disease results to major U. S. Reference laboratories. Speaker 200:21:02We believe we can utilize their retail networks to collect patient samples, which would potentially allow us to provide testing to Lyme patients across the country. These samples would then be sent to our LDT laboratory partner to perform the T2Lyme Panel in their lab. Again, it's important to note that T2 line panel sales are not in our current 2024 guidance. So any potential sales during 2024 represent upside to that guidance. The expanded T2Candida Panel, which will include the detection of Candida auris is a direct from blood molecular diagnostic test designed to detect Candida species in just 3 to 5 hours without the need to wait days for a positive blood culture. Speaker 200:21:46We believe the addition of Candida auris test will strengthen the value proposition of our T2Candida panel and lead to increased adoption. Candida auris is a multi drug resistant fungal pathogen that has a mortality rate of up to 60% and is recognized as a serious global health threat by the CDC and the World Health Organization. The CDC estimates the costs associated with U. S. Fungal diseases are as high as $48,000,000,000 annually and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the life saving benefits of early detection and proper treatment. Speaker 200:22:27A 2022 Journal of Clinical Microbiology study conducted at the Bambino Gizhou Hospital in Rome, Italy found that pediatric patients suspected of fungal bloodstream infections that were tested with the T2Candida Panel received species identification results 121.8 hours faster compared to blood culture based diagnostics. Finally, we're also pursuing expanded claims for our FDA cleared T2Candida Panel and T2Bacteria Panel to include pediatric testing. In December 2023, we submitted a 510 premarket notification to the FDA to expand the use of the T2Candida Panel to include pediatric testing. And we expect to submit a 510 premarket notification to the FDA to expand the use of the T2Bacteria Panel to include pediatric testing during 2024. With that, I'll now turn the call over to John Sprague to provide a detailed update on our Q1 financial results. Speaker 400:23:29Thank you, John. 2nd quarter 2024 revenues were $2,000,000 all from sepsis product sales. Sepsis test panel sales increased 27% compared to the prior year period and increased 12% compared to the Q1 of 2024 led by increased sepsis test sales offset by lower international instrument sales. 2nd quarter 2024 cost of product revenues were $2,700,000 a 45% increase decrease, excuse me, compared to the prior year period, driven by increased sepsis test sales and lower international instrument sales. Research and development expenses were $3,400,000 a 13% decrease compared to the prior year period, driven by decreased trial activities. Speaker 400:24:19Selling, general and administrative expenses were $5,500,000 a 13% decrease compared to the prior year period, driven by decreased headcount spending. The Q2 2024 net loss was $9,200,000 $0.66 per share compared to the prior year's 2nd quarter net loss of $6,300,000 $7.84 per share. Cash and cash equivalents were $4,200,000 as of June 30, 2024 and we raised $7,300,000 in net proceeds from a private placement stock sale in the quarter. The CRG debt conversion reduced our debt by almost 80% and interest expense by almost 70% compared to a year ago. In 2024, we continue to expect total sepsis and related products revenues to grow between 49% 64% to $10,000,000 to $11,000,000 over 2023 and this target excludes any potential sales from our T2 BioThreat or T2Lyme panels. Speaker 400:25:25Thank you and back to John Sperzel for closing remarks. Speaker 200:25:32We are highly encouraged by the progress made in the Q2 of 2024, including record sepsis test sales, significantly improving our balance sheet, materially improving our cost of product revenue and reducing our operating expenses. Moving forward, we're excited by the potential to accelerate the growth of our sepsis business in the United States and internationally. We're also excited by the potential near term catalysts, including the opportunity created by the B blood culture media bottle shortage, the U. S. Commercial launch of our T2Lyme Panel for the detection of early Lyme disease planned for the Q3 of 2024 and the potential to establish a U. Speaker 200:26:16S. Commercial partnership for the distribution of our products with a multibillion dollar healthcare company. Our pipeline is also rich with potential catalysts that have already received FDA breakthrough device designation, including the U. S. T2Resistance Panel, which we plan to submit to the FDA for 510 clearance during the Q4 of 2024 and the expanded T2Candida Panel to include the detection of Candida auris. Speaker 200:26:44With that, I'd like to turn the call back over to the operator to open the line for questions. Operator? Operator00:26:49Thank you. At this time, we will be conducting a question and answer session. The first question is coming from Kyle Mixon from Kennard. Kyle, your line is live. Speaker 300:27:31Hey, guys. Thanks for the questions. So just wanted to talk the second half of the year outlook, what you're expecting there. So whatever you're seeing internationally in terms of like just the pipeline, the deals and orders and when you could place those instruments and also utilization internationally? Like could anything ramp up maybe like towards year end or something? Speaker 300:27:51And obviously, you have guidance for full year, but how should we think about Q3 and Q4, as we kind of go ahead here? And obviously, like there's revenue as a component of that as well as margin. So if you could just maybe parse those out and help us think about that would be great. Speaker 200:28:06Sure, Kyle. So on the last call, I mentioned that the company was at an inflection point. And I continue to believe that, and I also believe that the progress that we made during the Q2 reflects that. To get to your questions, in terms of our guidance, if you look at the guidance that we have given and reiterated both at the beginning of the year and at the end of the first and now the end of the second quarter, we expected somewhere between $10,000,000 $11,000,000 of product revenue, which is in the range of mid-forty percent to mid-fifty percent growth year over year. And it was weighted approximately 40% in the first half of the year and 60% in the back half of the year. Speaker 200:28:52And we continue to believe that, that is the appropriate mix first half versus second half. So we expect a very good second half of twenty twenty four, given all of that that I said. In terms of our international business, it continues to be strong. We continue to expand our distribution network in international markets. We added a number of countries during the Q2. Speaker 200:29:16We expect to add additional territory exclusive distribution agreements in the second half of twenty twenty four. When it comes to instruments, we had 2 instruments in the Q2, which admittedly was lighter than we expected. We had a number that were close to the goal line at the end of June, which essentially rolled over into July. And I referenced in the prepared remarks, we already have 6 instruments sold in international markets, which will generate about $400,000 in Q3. As far as utilization is concerned, it's much more difficult to track utilization in international markets because we're selling through distributors and it's a little more difficult to parse out what product might be in the pipeline and what product is in customers' hands and what product has been used, and it's much easier to track that in the United States. Speaker 200:30:09In the United States, utilization continues to increase, and we continue to believe that all of our U. S. Customers and customers that we have in the future could get to approximately $200,000 of annualized infectious test revenue. Speaker 300:30:27Okay. Thanks for all that. And the partnership with the, I think with like multibillion dollar healthcare company, What are the like the financial implications of that? And when could that kind of come through? Like I'm just, for example, if that's a distributor, could that increase, I guess, like placements and stuff? Speaker 300:30:46Or does that really not have to do with consumable utilization? Or is it something where maybe it's like a partnership that will actually boost pull through basically or something? I'm just trying to think about how that's going to affect the model in years going forward. Speaker 200:31:03So our objective with a U. S. Commercial partner, first of all, is to find the right one, the one that has presence across U. S. Hospitals, that has a physical presence in the locations within the hospital and has scale because one of the things that we lack as a small diagnostic company, particularly in the United States, is commercial scale. Speaker 200:31:26And so we have been working to address that. And we feel confident about the partner that we are negotiating that with. Obviously, confident enough that we would mention it on this call. As far as details about that potential agreement, Kyle, I can't get into that yet. But most certainly, once we have finalized that, that would be something that we would share with the market. Speaker 300:31:53Okay. And some of the studies that yes, sorry, go Speaker 200:31:57ahead. I said we're certainly excited about it. Okay. Speaker 300:32:00And then some of the studies that, I guess were sort of it sounds like a little delayed, maybe some of the submissions were a little delayed. Is there any risk that was get further delayed? And how important was that timing of that? If you look if you kind of think about how the milestone to shape up for you going forward? Or was timing kind of like not the most important thing this year? Speaker 200:32:22Were you talking about T2Resistance, Connor? Speaker 300:32:26Yes. It also sounded like some of the clinical studies maybe were a little bit either delayed or sort of like slower than expected, but I'll let you kind of take that. Speaker 200:32:34Sure. So let me just take the couple of things in our pipeline. T2Lyme, those studies on track, on time and they're completed. The tissue resistant studies were delayed for one reason and that was that we had a manufacturing issue that we had discussed with the market in the back half of twenty twenty three, which we have resolved. But that delay forced us to prioritize where we shipped the product that we actually made, again, for teacher resistance. Speaker 200:33:06And we made the, I'd say, obvious decision to supply our current customers in Europe and not to supply ourselves so we could get those clinical studies done. Or sorry, the internal verification validation studies. So the field clinical studies for T2Resistance are completed. What's left are internal verification validation, and we have resumed those. It did unfortunately push our planned submission to FDA from Q3 of this year to Q4 of this year. Speaker 300:33:38Okay. Got it. That makes sense. And then then just kind of looking at the P and L and SG and A, it remains pretty relatively low compared to like prior year level levels and recent levels. Are you thinking about, I guess, increasing sales force anytime soon or not? Speaker 200:33:59Absolutely not. In fact, we have reduced our sales force, particularly in the United States, not internationally, but we reduced it in the United States because we expected to have a U. S. Commercial partner. And what we have as our U. Speaker 200:34:17S. Sales team are people that we believe can effectively work with the partners that we're engaged with. So we haven't done it by happenstance. It's part of a planned strategy. Speaker 300:34:34Okay. And then just a final question about the balance sheet. Is there anything you could kind of share regarding like moves that you'll maybe make in the second half of the year here just to kind of like shore up the balance sheet and just make sure you have enough entering 25%. You made some moves recently, but the cash position, maybe it's not totally ideal. So maybe just like a little bit of like a preview, I guess, of anything to put in the model for us? Speaker 200:35:05Todd, what I could say about that, we obviously filed an S-three, we put an ATM in place. We obviously want to have the tools available in these markets. We also want to be smart about when we strengthen our balance sheet. We have a whole bunch of catalysts in front of us that I described partly in this Q and A, but also in the prepared remarks that we think are going to be excellent vehicles for us to strengthen our balance sheet around. Speaker 300:35:33Perfect. I'll leave it there. Thanks guys. Appreciate it. Speaker 200:35:36Thank you, Kyle. Speaker 300:35:38Thank you, Kyle. Operator00:35:38Thank you. There were no other questions in the queue at this time. I would now like to hand the call back to John Sperzel for closing remarks. Speaker 200:35:46I would like to say thank you all very much for joining our Q2 2024 earnings call and we look forward to updating you as we progress through the back half of twenty twenty four. Have a great day.Read morePowered by