genedrive plc (GDR.L) Earnings Call Transcript & Summary
September 3, 2026
Earnings Call Speaker Segments
Unknown Executive
executiveGood morning, ladies and gentlemen. I am going to make a slow start for any people that are joining us in the next minute, making sure that we can get everybody into this webinar. So good morning to the shares of webinar. Today, we are focused on genedrive. My name is Thera Prins, I'm a Director of ShareSoc, and I will be your host for today in assisting those questions later. Today's presenters that will be joining after I've done the introductions will be Dr. Gino Miele who is the company's CEO of genedrive; and Russ Shaw, CFO of genedrive. As always, before we get into the material, Third, I ask you to participate into a quick poll because we always like to stand from participants, whether you are currently invested in genedrive, so please could I ask you to participate in this call. Fantastic. So thank you very much for participating. And Gino and Russ, I see here that we have 77% of people on the call who already invested in the business. So that is hugely interesting. And [indiscernible], no doubt very much looking forward to this presentation. Okay. Next slide. I have to do this, which is basically our sharehold disclaimer. Just a reminder that this is not investment advice that you're going to receive next by ShareSoc. We always encourage you to do your own research and/or take professional [indiscernible] before making any investment decisions. So thank you for that. And then I would be fully sure if I didn't take the opportunity to spend a moment to just going a bit about ShareSoc. Many of you will probably be aware already that ShareSoc is a not-for-profit organization -- membership organization, our primary activities are investor education and representation, looking after the interest of all our private investors. We also campaign [indiscernible] lobby government regulators, companies and brokers on your behalf. In terms of direct membership services, we inform, we educate and we connect through a variety of forums, seminars, newsletters and through our Signet Group. We also tried to save you some money with various discounts that you get made available to you by being a member. Thank you for the slide [indiscernible]. [Operator Instructions] Okay. And without further ado, let me just -- it gives me great pleasure for me to stop talking and hand over to Gino and Russ. Welcome Gino and Russ. Please join me on the screen. Brilliant. And Gino, welcome, Russ. And I know you're going to go into your presentation. And one thing I would ask of you is -- we starting with yourself, Gino, is I always love to understand a little bit about how long you've been with the organization. Where in the world are you would love to know 1 or 2? Who are you [indiscernible] from you if that's okay?
Gino Miele
executiveYes. I'm Gino Miele, Chief Exec in genedrive. I have been [indiscernible] since September 2024. But I have been with the company since its inception as genedrive since 2016 and prior to that, its legacy business [indiscernible]. I've been with the company a long time. My background is predominantly a novel disruptive diagnostic and placing those into developed health care settings and commercialization there. We're based in Manchester, our company headquarters in Manchester, but we operate through the NHS and internationally as well.
Unknown Executive
executiveOkay. I understand. And what about yourself for us, lovely to have you join us today.
Russell Shaw
executiveYes. Thanks very much. Good morning, everyone. So I'm Russ Shaw, CFO of genedrive, also based in Manchester, I've been with the company, not quite as long as Gino, 4 1/2 years. [indiscernible] 25 years [indiscernible] life sciences, diagnostics, technology, industrials, predominantly within quoted companies, we experienced a diverse range of businesses covering technology business turnaround. And I was previously CFO of a private company that scaled to over GBP 100 million in turnover.
Unknown Executive
executiveThank you for introduction. On that note, it's time for me to stop talking. And Gino, I think I'm handing over to you. So controls over to you, sir.
Gino Miele
executiveOkay. Great. Well, listen, thanks for joining us. Good afternoon. Really delighted to introduce genedrive to you. Some of you know us, some of you don't. We're a U.K.-based med tech company, and we are focused on transforming patient outcomes through what we call pharmacogenetic testing. Our work sits a very, very exciting intersection of genetics, acute care, preventive health care and NHS productivity. And we're not talking about distant science here. We're talking about rapid tests that are available today that help clinicians make better prescribing decisions, and those decisions can be taken at exactly the moment where they matter. So today, over the course of the next 25 minutes or so, I'll try and cover the clinical need and the market opportunity. Our commercial progress. And importantly, why we believe genedrive is increasingly well positioned for scale. And then at the end of the presentation, Russ and I will take questions. And just to note that any remaining questions that are submitted that are unanswered, we will absolutely endeavor to provide responses to those afterwards. So if we could just move to Slide 2 and 3. These are standard disclaimer slides, and I'm just going to pause very briefly here. And they're important because some of our presentation does a market opportunities, anticipate milestones, risks and forward-looking statements. So please read the slide after the session, if you wish. And of course, nothing today should be taken as net investment adviser. But with that, let's target the story that really matters, patient impact and commercial execution. So what genedrive in action? This slide captures that. On the left is our MTA R&R 1 test, there's a test that's designed to help prevent antibiotic induced hearing loss in newborns, very vulnerable stage of their life. The issue here is that around 90,000 babies are admitted to [indiscernible] care in the U.K. each year and a proportion of these care well-known genetic variant that means that if they're exposed to the immunoglycosyte class of antibiotics, that results in a devastating impact on their hearing, lifelong, irreversible hearing loss. So our test is a rapid test that allows clinicians to identify those babies within minutes before treatment decisions are made and that ensures that babies with this variant that are identified and not exposed to these antibiotics. And instead, they're given safer second-line alternative i.e., we avoid preventable harm in these newborn patients. On the right is our CYP2C19 genetic testing for stroke pathways and transient ischemic attack pathways where a commonly prescribed platelet drug capital is widely used. But the clinical issue here is that a significant proportion of patients don't respond adequately because of their genetics and it's a very high frequency. Approximately 30% of people and even higher in certain ethnic groups up to 56%, don't respond adequately to this commonly prescribed medication. Again, a point of high vulnerability in their life. So our rapid testing genetic solutions help support a move to the right patient to the right treatment at the right time. The key point is very simple. We're targeting moments for a fast generic answer, but some of the most vulnerable times and someone's life can profoundly change that person's life. And at the same time, we're offering significant health economic benefits, productivity gains and reducing downstream health care costs via true significant savings to organizations such as the NHS. So move to the next slide, a glance. We're a commercial U.K. pharmacogenetic testing company. We have a U.K. supply chain, and we're focused on solutions for enabling time-critical treatment decisions. We have to -- we have a product rapid molecular platform, which is the engine behind everything, and we serve NHS international market. On that instrumentation, we have 2 CIVD certified products, which have been developed with and are used by NHS partners currently in routine clinical care pathways. And we believe our investment case for us is built around 6 key points. First of all, we're a commercial stage. Secondly, we have 2 products addressing high-value clinical needs, and these are global significance with respect to that clinical need. Third, there's a meaningful market opportunity, both in the U.K. and internationally. Fourth, our clinical and regulatory positioning is strong, including recommendations from NICE for use in the U.K. NHS, and we're also very well aligned to U.K. political and health care drivers. Fifth, we see -- we're seeing early commercial traction and increase in revenues and sixth, the business is positioned for scale through a recurring consumable model, manufacturing capability emergence of defined market access and reimbursement route. Again, these are novel diagnostics. They're disrupting clinical pathways and the path we involved with us. But in short, we're a platform business moving from evidence into adoption and growth. With respect to the unmet clinical need, I think that's relatively easy to articulate and understand and I'll try and do so. People respond very differently to medicines and your DNA is one of the reasons why. In fact, a very high proportion, people carry at least one so-called actionable variant for a very common set of medications. So in the hands of prescribing position, knowledge of those actionable changes can have significant and profound impacts providing benefits. And historically, that pharmacogenetic testing has been performed in -- and is performed in cental diagnostic labs. And that pathway has value. Of course, it does, but it can take days or weeks. And so it's only appropriate in certain instances in acute health care settings. So for example, neonatal intensive care, stroke units, other emergency care settings, clinicians don't have that time. They need to make decisions quickly. And to do that, they need the genetic results quickly. So we're focused on bridging that gap, bringing actionable genetic insight to the point of care, but fast enough to influence the first prescribing decision rather than explain it after the consequence. And this is where we come in, enabling the right prescription for the right patient at the right time which is the essence of personalized medicine. And this is our solution. It's enabling that rapid near-patient pharmacogenetic testing but at the point of clinical decision-making where it's needed. So the system is designed and proven to be practical and busy clinical environment and where the focus is on care of the patient and not negatively impacting that. That's really important. It involves a very simple check swap sample automated analysis in the instrument and the user is presented with an actionable genetic result without having to do any data analysis. So simple enough to run whilst we're focused on delivering other important aspects of care. And it's really important to evidence that in real-world settings. For MT-RNR1, results are available to the clinician as little as 26 minutes, which is crucial because it's well within what's called the Golden [indiscernible] requirement of antibiotic prescription following the decision to treat in neonatal sepsis. For [indiscernible], the aim is to inform [indiscernible] choice quickly enough to matter in stroke pathways. The important word here in both cases is actionable. We're not generating genetic debt for its own sake. We're providing a result that can meaningfully change a prescribing decision in emergency health care pathways. And this is what we believe next genedrive exciting. Rapid results actionable decisions, better outcomes for patients and health care systems. And this is all powered by our single-use ID kits that also create a scalable recurring consumable model. Next slide. So the market opportunity. Timing here is important. Rapid genetic testing, rapid pharmacogenetic testing is moving into routine clinical care pathways and we are solution ready. We're not coming after the event. We're coming with the event. We've got nice recommendations the NHS focus on prevention and productivity, very strong health economic evidence and a growing body of guideline adoption. And all of these are pushing in the same direction. So the market dynamics and drivers are strong. We estimate an annual total global opportunity, maximum of approximately GBP 480 million across the markets shown. And that includes approximately GBP 26 million in the U.K., approximately GBP 190 million in markets which recognize our existing CE/IVD certifications. And of course, there's further opportunities in additional regulated markets, one of those being the U.S.A. So for investors, the message, I think, here is important to take away is it isn't a narrow clinical research niche. It's an unmet clinical requirement of global significance that we're addressing. It's a growing market, I mean that's emerging in developed healthcare [indiscernible], but it's also aligned with what health care systems are trying to do with respect to improved patient outcomes whilst resealable costs product positioning, I'm going to take you through for [indiscernible] products. So for the first one, MT-RNR1. Again, we've gone through some of this, but just to reiterate, this is a very powerful example of vent to precision medicine in practice, around 1 in 300 -- 1 in 500 people carry this variant, this high-risk MT-RNR1 DNA variant and it's -- but if you're a newborn baby that has that variant and you're exposed to immunoglycoside antibiotics, your neonatal care, the consequence could be found irreversible and lifelong hearing loss. This can be avoided. The clinical challenge that as aminoglycoside antibiotics are used urgently in neonatal care, and the treatment window sort of the clinician nice guidance, say, within an hour of the decision to treat [indiscernible] sepsis. And this is why a test that can deliver a result in such -- in a short time frame is so important. A simple [indiscernible] swab near the point or can inform safer antibiotic decisions during that critical window. And for the AHS, the value case here is also compelling prevents avoidable hearing loss and it improves outcomes for babies and families whilst also avoid a substantial downstream costs. So for genedrive, for us, this intervention pathway exemplifies our core value proposition, fast generic insight, real-world prevention of avoidable harm and clear health economic value to health care systems. Our commercial progress is on the next slide for MT-RNR1. And the progress has been encouraging. Remember, these are novel disruptive products with pathways being created that aren't there at the moment. So our progress has been encouraging, as safe following recommendation for use in the nice -- in NICE, sorry, in the NHS via the NICE early value assessment. Our subsequent funding by [indiscernible] Life Sciences and [indiscernible] U.K., which is run by [indiscernible] here in Greater Manchester. That was recently completed with respect to patient enrollment. We enrolled nearly 6,000 babies across foreign sites in all 4 U.K. nations and the study report and the findings from this are going to be made publicly available and submitted to NICE very shortly as we've disclosed. We've got gene clinical service for this product and around 20 old units across the U.K. and Ireland. And importantly, implementation of this is underway at national level throughout the health boards of NHS Scotland. Importantly, this is just a U.K. story. We have a memorandum of understanding with the Saudi Arabian Minister of Health distributor in the region. And obviously, that has the ultimate goal of national implementation in Saudi Arabia. We also have routine use in the National Guard Hospital in Saudi Arabia. You may have seen our recent announcement of implementation Erasmus Medical Center in Netherlands, which is a leading intuition, particularly with respect to pharmacogenetic testing and we have an expanding qualified distributor network. So international traction whilst it's early, is growing. Overall, we -- overall to date, we've treated -- we've tested more than 30,000 babies or 13,000 babies have been tested. And more than 4 of those have been protected from lifelong defines and crucially for this type of -- it has an evidence ability to implement it in a busy emergency care pathways and that creates a very strong foundation for wider adoption both in the U.K. and subsequent international scale issue into. So CYP2C19. This is our second major product opportunity. The clinical need here is also very clear. Around 1/3 of patients don't respond adequately to the commonly prescribed drug the platelet drug clopidogrel. And as I said earlier, this can be up to 56% in certain ethnic group. I think you'd all agree that after a stroke or a transient ischemic attack, select and the most effective antiplatelet therapy quickly is critical. Yes, up to 2/3 of patients may be prescribing medication that's not effective for them. So [indiscernible] similar pathway to the [indiscernible] test in that it uses a simple cheek swab automated analysis of a complex genetic test, but prevents simple actionable results in around an hour to prescribing clinician at the point of need. So the purpose here is very clear is to help clinicians identify those patients who should be considered for alternative and platelet strategies rather than relying on a medicine or genetic may make less effective. And the value case is also substantial. As you can see in this slide, it's got the potential to prevent recurrent stroke, release valuable bed days in the health care system save health care professional time and deliver significant NHS value not only in the first year, importantly, but accumulating over several years. So there's a high-impact, high-value opportunity in a major project care pathway and it's scalable and highly economically significant. Our commercial progress with CYP2C19. So this is also CIBT certified, and it's also recommended by NICE in the U.K. for use in the NHS setting. And there's also an NHS England implementation guide that's been published for this type of testing to help clinicians understand how to embed it their pathways and the downstream care pathway that's required. We're seeing routine use in leading stroke centers. We have our Scotland test of change pilot underway, which is looking at the benefits in rural settings versus centralized laboratory testing and accelerating commercial adoption. Very importantly, were accepted onto the NHS dynamic purchasing system for both of these products, and that provides a framework for procurement. Internationally, we're -- we're making progress through distributors in Europe and the Middle East and our U.S. FDA submission pathway has progressed under the 510(k) pathway. There are also important expansion [indiscernible] stroke to take no though, particularly in cardiology, including coronary syndrome, where this drug is also used and also a particular note here is our laboratory-based pharmacogenetic test solutions, and this is through our product development collaboration with Thermo Fisher, which we announced recently. That breadth matters. It means that CYP2C19 has several routes to scale and support point care testing and acute signing, whilst also opening the route to laboratory and wider precision medicine opportunities. And with respect to the political drivers, the policy environment in our space is increasingly supportive in the U.K., and the company is very well aligned with national priorities. The NHS 10-year plan emphasizes prevention and genomics is identified as a transformative technology that can support earlier diagnosis, better outcomes for patients and deliver long-term value. The U.K. life sciences sector plan also supports innovation, commercialization and supply chain resilience and genomics and diagnostics. So for us, this really matters because our products are completely aligned with the direction of travel, prevention for personalized care, productivity and faster adoption of effective innovation and premarket engagement and procurement signals that are emerging are also important because they provide visibility of future routes to adoption at scale in the U.K. So the market is moving towards what we do on the solutions that we offer. This shows it's a bit of a busy slide, but it shows you why we believe genedrive is positioned for scale. Here in the U.K. alone, as I've said, there are 90,000 babies in [indiscernible] each year and around 100,000 new stroke patients annually. The annual value opportunity to the NHS has also shown is approximately GBP 20 million per annum for MT-RNR1 and approximately GBP 91 million for CYP2C19, that's valued at the same time of delivering real tangible better outcomes for patients. For the U.K. is strategically important to us because validation and adoption here can support international expansion in the Europe, Middle East and the rest of the world and the models attract a simple, rapid point of care solutions with a high gross margin, recurring consumable model, embedding in clinical pathways and a platform approach that can support future tests. The adoption pathway required is relatively clear. There are several milestones to get through, several gates to get through, but that spans clinical validation, evidence generation in the U.K., nice recommendation embedding in routine clinical practice and implementation at scale. And the implementation at scale is the piece to take note of and that has reimbursement, obviously, to enable prevention-led interventions, and we're moving through that pathway with increasing momentum. With respect to our journey, our journey over the years has covered early concept and clinical validation through certification, regulatory progress nice recommendation, NHS adoption, and we're now moving towards U.K. penetration and subsequent international expansion. And this is what's important here. Each stage is built on the last. The technology is being developed with a focus on addressing high impact, unmet need, evidence has been generated through clinical studies and publications regulatory certification to be put in place, a nice recommendation and NHS implementation guides have helped support the pathway adoption to where we are just now. But today, we can point to real-world use thousands of babies tested, babies protected from lifelong debtness, expanding stroke adoption and growing international partnership. And our mission here remains consistent, as always, has rapid accessible, actionable pharmacogenetic test doing to transform patient outcomes. With respect to key financials, our financial story is also one of growing commercial momentum and capital discipline. The revenue trajectory, as you can see here, has moved from approximately GBP 0.06 million in FY '23, our financial year ends in June to GBP 0.5 million in FY '24, GBP 1 million in FY '25 and approximately GBP 1.4 million expected for FY '26 just ended in June. So our revenue growth is increasingly driven by commercialization both of these products, MT-RNR1 and CYP2C19. And we have early international sales beginning to contribute. As a business, we remain lean. We're running for FTEs. Our operating cash burn is approximately GBP 0.35 million per month, and we've reported cash at 30th of June 2026 will be approximately GBP 3 million unaudited. The message I want to convey you here is that genedrive is a capital-light business with a recurring revenue recurring consumables revenue opportunity. We have a target transition to positive EBITDA in H2 FY '27, whilst we're very focused on growth and efficiency. So if we move to the next slide, the investment case for us, we believe, is straightforward. We have year-on-year revenue growth to date, a growing recurring consumables opportunity, capital-light business, expanding U.K. adoption and growing international distributor partnerships. Our current commercial focus is very much on the U.K., Europe and Middle East, but there are additional regulated market opportunities over time. So the addressable market is financially meaningful, but importantly, it's grounded in real clinical pathways, neonatal care, stroke, cardiology and pharmacogenetic testing. And that combination of patient impact health economic value and commercial scalability is what we believe makes them drive an exciting med tech growth opportunity. And we believe the company is now moving from proving the technology to adoption and implementation at scale. Looking ahead, there are several -- with respect to news flow. There are several important catalysts for investors to follow through this financial year and this calendar year, for MT-RNR1, we expect continued business as usual progression in existing clinical sites under the [indiscernible] program, progression of business cases in additional U.K. NHS trusts to implement the technologies evidence generation submission and our participation in the nice accelerated access pathway. And of course, this progress towards U.K. national reimbursement. For CYP2C19, our focus includes U.K. point-of-care progress through NHS Integrated Care Board, international progress in Europe and the Middle East progressed on our Thermo Fisher both collaboration and our FDA submission progress. From the news flow is important, it reflects multiple reached value creation, commercial adoption, clinical evidence regulatory process -- progress, procurement access and international expansion. And of course, we will strive to report on these as soon as we're able to do so at the time we're able to do so. So to summarize, I hope I'm leaving you with a clear message. As a company, we, genedrive are focused on saving lives, improving patient outcomes and reducing health care system costs. We're addressing critical clinical needs in neonatal care in neurology and cardiology, and we have products that are supported by clear evidence and guideline adoption, early commercial traction, U.K. leadership and growing international partnerships. We firmly believe the future is exciting because health care systems are moving towards prevention, personalization and productivity, and this is exactly where our rapid pharmacogenetic platform can contribute an impact. So we think genedrive has the potential to deliver long-term, long-lasting value for patients, health care systems and core shareholders, patient impact, scalable growth, long-term value. And I'm going to finish on the final slide, which is just for further information. If you -- you have the QR codes here and the URL. For further information, please follow these links. The one on the left is for the company, where you'll find lots of information about our product and the other is for our investor hub platform where interested current and prospective shareholders can sign up to receive news alert and also engage in Q&A directly with the genedrive team. So with that, thank you for your time. I hope it's clear, we're excited about the journey ahead, and we look forward to updating the market as we continue to execute. And with that, I'll hand back for the Q&A session. Thank you.
Unknown Executive
executiveWelcome, Gino, thank you very much. Okay. I think I am [indiscernible] going to start with 2 questions perhaps that I have from your presentation. And I noticed that a few people on the call had a similar question. And that is, as a clarification point, is the focus of the business on these 2 tests, in particular, a knock on to try and play back the code references that you so ably articulated. But a key question is, are there any new tests in development? Or is the business 100% about the current 2 tests?
Gino Miele
executiveI can take that one. I mean the current focus and priority is absolutely on these 2 targets. And the reason for that, I hope was clear in the presentation that there's a clear unmet need and there's clear political drivers towards this, and they have a clear place in the care pathway. And there's a really strong rationale for them. The results are needed quickly. There are other emerging genetic targets that will evolve over time and that can also be done on the platform. There is also the laboratory-based pharmacogenetic testing that I hope I've given you the flavor for that we have the opportunity to broaden into. But for now, it's very much laser-focused on the commercial opportunities with these 2 products.
Unknown Executive
executiveOkay. I'm going to stay on this theme, if that's okay, because there were a few more technical questions. So I think why don't we work those through. A question that's just come in is, of the 14 hospitals that 2 parts in the Palo U.K. pilot, how many of them have transitioned to business as usual?
Gino Miele
executiveSo we've announced the ones that we can announce, but I would say the majority have but we're not at liberty to talk about the remaining ones just yet. However, we're confident that there's progression.
Unknown Executive
executiveOkay. Again, a couple of more technical questions. I'll come to a revenue point in a moment, but just a few technical questions [indiscernible] come up. The first one being, you're relying on NICE final guidance mid-2027 as the trigger for uptake. Why isn't there an active preguidance adoption push given NHS Trust can and do adopt point-of-care diagnostics ahead of formal technology appraisals where local business cases suggest that makes sense.
Gino Miele
executiveAgain, I can take this one. I think it's a very good question. I think that's a question I love and more people to direct NHS England and NICE. But the reality is that -- the issue with pathways like this where you're delivering value downstream of where the cost implication is. there's always that funding silo that becomes difficult to overcome. You're inducing a budget in someone's department that didn't have it before while saving money in a downstream pathway. So unless there funding in -- within the same umbrella of the people who are incurring the cost is recognized in the savings, but it's always difficult for people to move that around. And that's what the system is trying to change. So the technology assessment pathway aligns medtech medicines, which creates an environment where health boards have 90 days, I think, legally to consider implementation and if it's been nice recommended and if not provide reasons fine. And that comes with financing. That's the intention of NICE through NHS England. But it's important that you move this moved the funding up to ICB level up to national level. And that's what these 2 pathways are aligning to the July 27 date is important for us because, obviously, that's when NICE have communicated, they'll release their final recommendation based on all the evidence that submitted, but it's also the timing that NHS England have indicated that the procurement tender pathway will coincide to be in time for. So both of those pathways are aligning to that point in time next year.
Unknown Executive
executiveThen I think on an aligned theme, a few question that's come up is competitors like UniHealth, [indiscernible] are now consulted on the same NICE appraisal, what's stopping them taking first-mover commercial position while genedrive weights on guidance?
Gino Miele
executiveThey're subject to the same -- so you [indiscernible] a distributor, Credo is the manufacturer that are based in Singapore. And they're subject to the same evidence requirements as genedrive. So the early mover first advantage isn't available to them without going through the nice pathway in the same way that genedrive has.
Unknown Executive
executiveNext question on the technical content. When will the Thermal Fisher collaboration be complete? And what's the potential value of high throughput testing, especially in the U.S.A. worth year?
Gino Miele
executiveYes. I mean I think -- I mean I hope at the moment, we shouldn't speculate past what we've announced. The focus is on developing a laboratory base test for use in centralized diagnostic laboratories. It uses our expertise. It uses Thermo Fisher's expertise, but importantly, they're a global molecular diagnostics player with a large installed base in the diagnostic testing arena. Importantly, they have a wide coverage of pharmacogenetic test solutions and under many other tests that make sense in the laboratory pharmacogenetic testing space. So we see this as a first step in that, but we're focused at the moment on the opportunities that arise with a laboratory-based CYP2C19 test, in addition to our point-of-care test in markets. It's very complementary.
Unknown Executive
executiveSo having listened to your presentation, some of your answers here I think a key question that's triggered in my mind is, okay, your revenue prediction. What are the bigger revenue drivers as you look ahead? And what are the kind of indicators that you would point to investors to look at?
Russell Shaw
executiveI'll take that one, I think. So sort of several drivers that we look at, I think, first and foremost is progressing the national tender and the reimbursement pathway for NHS England. So that tends due to be announced in January, go live in July and that coincides with the nice financial guidance outcomes and evidence and that the adoption becomes repeatable, so moving away from reference sites into multiple routine implementations. So in practical terms, that means that site that transitions to the business as usual, as Gino was describing before and continued adoption through the NHS Trusts and regional ICBs. Important is utilization. So that once the site is installed, it becomes a recurring testing so that the activity is what demonstrates that we're embedded within the clinical called pathway. Beyond the U.K., so continued progression internationally. So as we go into countries, European countries and the Middle East, and obviously, the CYP2C19 lab test as well with the Thermo Fisher collaboration. So I think if we're making progress against all those areas, then investors will see -- we'll be able to see us more as a commercial diagnostics business.
Unknown Executive
executiveOkay. Which I think leads me nice on to the next question and also link a question I had, but also a question that's come up by one of the attendees. Clearly, your projection, Russ, you showed in terms of what your cash burn is and also your revenue. There was a question relating to, okay, that's your cash burn in FY '26, what's your expectation in '27, which leads to my question, which is what are the bigger milestones to become self-sufficient? What's the trajectory towards -- yes, milestones trajectory to become self-sufficient?
Russell Shaw
executiveYes. So I think sort of conceptually, the pathway is relatively straightforward, and it's about converting the clinical and regulatory validations and that the routine use tax volumes increases also keeping a very disciplined cost base. As the transition of the revenue with the individual deployments are generating recurring revenue streams with the clinical use and the utilization of those grows, the revenue characteristics of the business becomes more repeatable. And I think that, combined with achieving this in a very capital-efficient manner is what would drive us to being self-sufficient.
Unknown Executive
executiveSorry, sorry, thank you for the financial, Russ. Next question, Gino, I think probably we'll come back to you as I go through the list. Apart from your 2 lead projects, are there any other clinical unmet needs that could be addressed using the genedrive genotyping technology in order to rapidly identify the optimal drug regime for time-critical treatment? It's basically an opportunity question, Gino, what are opportunities for rapid testing are out there?
Gino Miele
executiveYes. I mean I would say the case -- the business case and the clinical case is the strongest for these 2 with respect to the requirement for urgent rapid testing in emergency care. But when you think about the opportunities for pharmacogenetic testing is outside of a diagnostic lab. It's broader than this. It's broader than MT-RNR1 and CYP2C19. There are groups of genes, relatively small groups of genes that can influence, as I said earlier, that start the presentation, drug response for a wide diversity of a wide range of common prescribed medicines, antidepressant, analgesics and such like. So you can envisage a world in the future where this type of pharmacogenetic testing is delivered outside of centralized laboratory, and we move away from trial and error medicine where your doctor prescribes a drug, 3 weeks later, it doesn't work. You increased the dose, you reduce the dose, you try a different one. You can prevent all of that by testing upfront, but that world is not here yet. That world exists in diagnostic labs, central labs.
Unknown Executive
executiveTalking about -- well, central labs, maybe put a link to this question. How long does it typically take to genotype your target patient using standard laboratory tests? And how does that compare with your MT-RNR1 -- your 2 tests basically?
Gino Miele
executiveYes, it's a great question, and we probably didn't cover it. I think it was in the slide, but I didn't cover it. So it's really important. Centralized laboratory test, it depends on where you live in the U.K. Obviously, if you are -- if you're part of our pilot test to change pilot in the Western Isles in Scotland, for example, you're getting your sample taken there and it's sent back to either Dundee or Glasgow. It takes anywhere from 3 to 5 days to actually do the processing and the testing and having the result getting that result back to the patient and back to the prescriber that needs it. Overall, it can take up to 2 to 3 weeks. The patient has normally gone from the care pathway at that point. They're further downstream. They're not accessible anymore how that compares to -- I should say, some labs, very well, very mature, very high throughput labs, maybe it will turn this around in a day, but it's certainly not minutes and hours, and that's what's required. And that's the advantage with our testing for RNR1, 26 minutes, for CYP2C19, just over an hour, whilst the patient is still there and the attending clinician can make the appropriate prescription.
Unknown Executive
executiveOkay. And then that was a question about timing and pace of turnaround. Someone has asked what's the average unit price per test?
Russell Shaw
executiveSo the DPS system has a list price of GBP 110 for the RNR1 test and GBP 120 for the CYP2C19 test.
Unknown Executive
executiveOkay. Thank you for that. And Gino, I think one for you. Could changing the names of your products to something that describes what they do aid adoption? Could it be more intuitive? I relate to that because you know [indiscernible] this morning.
Gino Miele
executiveYes. Yes. No, listen, I do take that. I think the names are the names of the genes they're recognized by the clinical and clinical stakeholders and pharmacy stakeholders, having by jazzy names that don't refer to the gene name isn't necessarily a sensible thing to do because no one knows what clinical pathway they're directing. But I take the point, they don't flow off the tone, but we don't name the genes.
Unknown Executive
executiveOkay. Thank you. Just so that -- I realized you talk to this, but I'm not completely clear in my mind. You've got some NHS Trust on board. How long does it actually take to onboard NHS Trust? So I recall your opportunity, market opportunity, U.K., Europe and America, but what does it take to get these tests into NHS Trust?
Gino Miele
executiveI mean I'd be honest about this. I mean it varies widely. You have to remember, at this moment in time, there's no national implementation and there's no mandate at national level to test when that becomes the case, I think the time frames will get more condensed a quicker NHS Scotland were very quick. They've taken out -- they've done their assessment, they've taken on. They've rolled out the scotch health boards all in the time that we're still going through nice assessment in NHS England. Trust in NHS England are -- they're looking to nice recommendation for implementation mostly. You do have early adopters, and you do have trust to have local funding options to support implementation. And that's very much behind our 20 or so sites that we're active in, in the U.K. at the moment. Of course, we believe that will change when we get to the point of national funding and mandate to test. But in terms of time frames, it can be anything from a few months to a couple of years, depending on the region internationally or in the U.K. without fail, outside of the U.K., there's always the steps to go through of registration key opinion leader pilot studies, assessment of those pilot studies, reimbursement pathways and codes and then implementation. That takes time, and it's different in each of those countries. But in the U.K. the path to that is becoming increasingly clearer. And as I said, at least for Ann, as we move towards that July date next year, which I must stress was communicated by NICE. It's not our time line, it's NICE's time line. that should be facilitated. But in the meantime, you may find sites that are wanting to adopt, but they're waiting for that final guidance and that final indication of reimbursement and how it's paid for.
Unknown Executive
executiveOkay. Understood. So that's quite a critical date for you as a business in '27. Okay. And then just linking to the international question because you showed, of course, the market opportunity internationally. What are you focused on? What does it mean for the business in terms of markets outside of the U.K.?
Russell Shaw
executiveSo yes, the clinical needs of the tests are global as Gino demonstrated with the market opportunity. So the real-world evidence an implementation that we're generating within the NHS, a very important foundation for expansion into other health care systems. So NICE has significant international standing, which is course is helpful to us. And we have seen encouraging progress in our near-term target markets of Europe and the Middle East. Recently, there was an implementation of the RNR1, Erasmus University Medical Center in Netherlands, alongside commercial activities progressing in Spain, Saudi Arabia, UAE and other countries. So the commercial strategy is to work with in-country distributors and clinical partners who understand the health care systems can help establish clinical commercial past grays in each local market and that would allow us to sort of expand geographically without building up large direct commercial infrastructure to sort of support each individual territory. So our focus is U.K., Europe, Middle East, the U.S.A. represents a significant longer-term opportunity, and we will continue with the U.S. regulatory pathway progressions and we'll update the market as those milestones are achieved.
Unknown Executive
executiveOkay. Understood. And just so that I am completely clear. I kind of asked this question again, but I want to ask it last time, last question for me. Where do you see the next big opportunity for your technology?
Gino Miele
executiveRNR1 testing in units and CYP2C19 testing in stroke. CYP2C19 at the moment is very focused on -- in the U.K., the NICE guidance revolves around recommendation for use in ischemic stroke and transient ischemic attack. But very importantly, as I think I alluded to earlier on the presentation, clopidogrel is also used in other indications in cardiovascular. And in the U.S., for example, the American Heart Association released a scientific statement that basically just said this type of testing should be done across all of these indications in which the drug is used. So I just want to reiterate, it's not a narrow clinical niche. It's a very, very large opportunity just with these 2 tests alone. I think, for me, the diversification to pharmacogenetics with laboratory-based testing opens up a number very interesting opportunities that may be available to us with our existing collaborations.
Unknown Executive
executiveComments come in saying I'm more impressed now. Final technical question. The question has been posed as this. Is the local wildlife affected? I don't know whether this references to animal testing or anything like that. I thought I would just -- that's where my brain went. So forgive me to the person who's put the question there if I misinterpreted it wrong, but...
Gino Miele
executiveIf the question is about animal testing, not from genedrive, our test don't have any relevance or requirement for animal testing.
Unknown Executive
executiveThank you for confirming that. Okay. I'm just going to have a last little counter to the questions. Okay. I think we have moved through certainly questions I had, and I think all the key technical questions. Gino, it probably doesn't come as a surprise to you that there are a few questions that I have gotten to because we've made a decision that a few of those questions, you will make a CEO, you make a commitment to get back to the individuals that asked them via e-mail as opposed to this webinar. So I would say to anybody on this webinar, I'm conscious that I have 5 questions on here that I haven't had the opportunity to get through that we have a commitment that we will follow up those questions outside of this webinar. Okay. Then that leaves me, Russ, Gino, is there anything you would have expected either myself or the attendees today to ask that hasn't been asked? Or final thing you wanted to cover.
Gino Miele
executiveNo, for me, just thanks again for your time and for your support. And I hope it's evident that we're excited about the opportunities that are directly in front of us.
Unknown Executive
executiveOkay. Well, we had 77 people join us today. So that goes to show how welcome and popular this update was. So I think we draw a line on that there. Thank you, Gino and Russ and well done as well for -- without seeing your audience presenting. Thank you to all our members that have joined and dialed in today. We will follow up on those questions. If there's anything that I can help with, you know how to get hold of me, please do not hesitate and we'll follow that up outside this meeting. And thank you, everybody, for joining today, and I wish you a very wonderful rest of -- it's Thursday, isn't it? It's Thursday. Thank you so much for today, everybody.
Gino Miele
executiveThank you.
Russell Shaw
executiveThank you.
Unknown Executive
executiveThank you. Thank care, and bye-bye. Bye-bye from all of us.
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