Microba Life Sciences Limited (MAP) Earnings Call Transcript & Summary

Hello, everyone. I'm very pleased to share an update on our progress following close of the quarter ended 31 March 2025. And for anyone new to Microba, after the quarterly update here, I'll zoom out and provide an overview of Microba's business. So if you're new, hold on and wait to that for the end. This is our standard disclaimer. I will move past that. So let me start by taking you through the strong numbers from the quarter. And that starts with our delivery of 240% year-on-year growth for our core diagnostic tests. So in Australia, we saw record months across the quarter for MetaXplore continuing to drive growth in test volume. And we just released yesterday in a press release landmark clinical study results for our MetaPanel test in inflammatory bowel disease patients, and that we signed a partnership with a major gastroenterology service provider to embed our testing into routine care. And in the U.K., we made great progress in migrating from our legacy testing products there to our focus on MetaXplore, delivering strong month-on-month growth across the quarter, culminating in over 98% growth between Feb. and March. And to exemplify that migration from legacy products in the U.K., you just have to look at this chart. So firstly, what you can see is sales starting to take off. And second, you can see here on the other axis that we've already replaced around 40% of the legacy GI test sales with MetaXplore over just a handful of months. And so this has been achieved, remember, just through the early access program to a select group of clinicians. And at the end of the quarter, the U.K. team had built a significant wait list of clinicians eager to access our market-leading product here. So safe to say we're excited about what Q4 will deliver in the U.K. And a quick reminder here that after years of work to distill the clinical value of microbiome testing and launch these world-leading MetaXplore and MetaPanel products into market, we've been strategically transitioning to focus 100% of our diagnostic team resourcing onto these core diagnostic products, and making great progress in liberating our team's focus to continue accelerating growth of our core diagnostics. And so if you've got any questions on this transition, we did a whole deep dive on our diagnostic strategy just recently and unpacked this in detail, and all of those materials are publicly available. So that transition of product and revenue mix has an impact to our Q3 revenues. But despite those changes, we delivered growth for Personal Testing and our Supplements, whilst transitioning from those legacy products, and, importantly, are forecasting a strong Q4 and another strong year of growth with full year revenue forecast that we put out there to land between AUD 15.25 million and AUD 16.25 million, representing between 26% and 34% growth for the full financial year. So another strong year that we're expecting. And aligned to this growth, there were a range of milestones and highlights from the quarter. We've summarized the key highlights here, but I'll take you through them in a little bit more detail on the following slides, which will span our continued momentum in Australia with our diagnostic test MetaXplore and MetaPanel, our growth in the U.K. with MetaXplore, and a transition from a research and development heavy phase to a capital-light sales and partnering-focused phase for our therapeutics. So let's start by diving deep on our diagnostic results for the quarter. So we're seeing continued strong growth in clinical adoption for MetaXplore in Australia, plain and simple. Month-on-month record sales across the quarter with over 3,200 tests sold for the quarter, which was up over 200% year-on-year. And that was underpinned in this quarter by opening up and bringing new clinicians into the top of the funnel. And that saw growth in ordering clinicians with around 700 ordering clinicians for the quarter, which was up 130% year-on-year. And we did this whilst maintaining and not diluting our average referral rate per clinician, which was impressive. And so the team remain incredibly focused here, have a growth formula which is working, and being supported by continued advancements in the product. And we've got several new feature releases scheduled in Q4, driving more clinical value and ease of use. Next, MetaPanel in Australia. Here we're in an active market development phase. And that's expected to take time. We're going to educate and develop these targeted clinicians and then have that flow through to meaningful adoption in sales. So how are we going on this market development work? Well, in short, the team are making great progress. So we've got those landmark study results for inflammatory bowel disease patients, which I'll speak to more on the next slide. The team have formally engaged multiple new key opinion leaders. And we inked a strategic partnership with major private gastroenterology clinic to -- sorry, with a major private gastroenterology clinic to include MetaPanel into their clinical protocols, and I'll provide some more details on that in a moment. Yesterday we announced these landmark clinical study results for our MetaPanel test in a press release. Now this data was from 2 independent clinical studies performed by 2 key opinion leaders in inflammatory bowel disease: Dr. Graham Radford-Smith and Dr. Jake Begun. And what this showed independently is that, for inflammatory bowel disease patients experiencing a flare, MetaPanel could identify pathogen in 35% of them. And more than 60% of those pathogens would be completely missed utilizing current routine testing methods. So why is this such a big deal? Well, a flare in these patients can lead to serious surgery. So detecting a treatable GI pathogen during a flare episode could provide a more effective path to remission through simply addressing a pathogenic infection, and help avoid those unnecessary escalations of therapeutics and reduce the risk of treatment failure and minimize the need for surgical intervention. So those results could lead to a significant advancement in clinical management for the 7 million IBD sufferers globally, and support the integration of MetaPanel testing into standard of care protocols. So the team are now working on writing up and publishing these results in peer-reviewed journals. And this is really exciting. These are really exciting clinical results for the MetaPanel test. And this flows nicely into our partnership with one of Australia's largest private gastroenterology services, which sees more than 10,000 patients annually: the Colonoscopy Clinic and Integrated Gut Health Clinic. Now the aim and purpose of this partnership is to embed Microba's testing into routine care to improve patient outcomes in gastroenterology. That's what we're trying to do. And the team at the Colonoscopy Clinic and Integrated Gut Health Clinic are real thought leaders and pioneers in providing the best care and pushing the boundaries of advanced precision care models in gastroenterology. So we couldn't have hoped for a better partner here. Now the key components of this partnership are routine use of MetaPanel and MetaXplore to support diagnosis and treatment decision-making; joint clinical research and publication efforts to quantify the impact of Microba's diagnostic test on patient outcomes; and to develop a next-generation gastroenterology care model centered on Microba's precision diagnostics. And important to call out, this is not conceptual. It's already started. The clinicians have already started using our tests and the studies and planning is already underway. We can't speak highly enough of this group and the work that we do with them here, we expect can set the foundation for advancing the gastroenterology care model at a global level. So a really big partnership for us, and excited on how this is going to play out for Microba. I've spoken to our progress in the U.K., but I don't want to skim past it and I want to underscore it again so it isn't missed. Strong month-on-month growth. We saw over 98% month-on-month growth between February and March. And our MetaXplore test at the end of March are already accounting now for around 40% of all GI tests sold as we migrate away from legacy products there in the U.K. And aligned to strategy, the whole U.K. testing business has shifted and transitioned its focus onto MetaXplore. And remember here, we've only provided access to a limited number of clinicians under an early access program, but now accelerating to full market access by the end of June. And whilst we're focused on delivering all of this diagnostic growth, Supplement revenues here have been maintained, which is good. And we have a small, focused team designing the next phase of growth for this part of the business. So stay tuned on that for a future update. Final update here for our diagnostics business is our advancement into the U.S. So the U.S. represents 60% of our target global addressable market. And put it plain and simple, it's time. It's time for us to start making our move into the U.S. Now the U.S. is a big pie. And so we're going to take it one slice and one bite at a time. So we've designed an entry strategy here with -- which is one state, one city, one metro area to start. And I've said repeatedly that one of the unique elements for Microba and our diagnostic products is that, unlike most diagnostic companies and products who rely on reimbursement to have a market, because of the deficiency of standard of care and how many patients have unresolved gastrointestinal issues, a significant portion of patients are willing to pay out of pocket for what can be a potential life-changing result. So our strategy is to leverage that, not have reimbursement as a barrier to entry, but as an adoption accelerant. So stage one of our U.S. strategy will be cash pay and deliver initial growth. And then we will have a reimbursement strategy, which will progress in parallel and come online as an accelerant to access and to supercharge growth. And the focus of stage one of our entry strategy is to get into market with a small sales and operational team and demonstrate strong clinician adoption and patient referral rates, and then expand from there. And aligned to all of that, we expect to have first hires completed before the end of this year. Now let's close off diagnostics and let's switch gears for a moment to an update on progress and our strategy for our therapeutics. We are declaring an important transition of our therapeutic activities. We've invested for over 5 years to develop a rich pipeline of live biotherapeutic assets that have leveraged our world-leading databank and deep preclinical and early clinical validation work. And we're now in a position to shift gears from this R&D-heavy mode that we've been in, into an R&D-light, capital-light, partnering-heavy and revenue-focused mode. And with that, our focus with a small team is now on partnering to advance these assets to bring them to patients and deliver a return on investment for shareholders with 2 commercial streams to value return, which I'll speak to just now on the next slide. So stream one is live biotherapeutics. So these are the traditional drug route, disrupting and advancing standard of care across multiple chronic diseases. Stream two is next-generation probiotics, disrupting the $79 billion probiotic market with new, healthy human-derived products, advancing from the work that we've just completed with the world's largest probiotic manufacturer, International Flavors & Fragrances. So we put more information on all of that into the quarterly release itself detailing the multiple partnering and non-dilutive funding streams that the team are focused on. And this is an important transition. This is an important transition of our therapeutic activities from what has been an R&D-heavy mode, to an R&D-light, capital-light, partnering-heavy, revenue-focused mode. And I'm truly excited by what we can achieve. We have a brilliant small team focused on accessing non-dilutive funding and partnering these assets to bring them to patients and ultimately deliver a return on investment for shareholders. So what's the focus and upcoming catalysts? Well, in diagnostics, we're critically focused on growth of our diagnostic tests in Australia, accelerating to full market access of MetaXplore in the United Kingdom and driving now to first access in the United States. And in therapeutics, we are executing our focused non-dilutive funding work and 2-track partnering activities that I just spoke to. At 31 March 2025, we had AUD 12.41 million in the bank. And so on that, I'll close the quarterly update here. But I'm going to respond to a range of submitted questions which came through. And then, for those new to the Microba story, I'm going to do a quick recap on the whole Microba business. So stay tuned for the questions, and then for those new, hold time for the recap on the whole Microba business.

So I'm going to take this in no specific order, starting with a question at the top here. The growth is positive in Australia and the U.K. Do you think this trajectory can continue? How big is the market? It's a big market. We have barely scratched the surface of it. We are only in the first thin slice of this with innovator and early adopter, solo clinicians that fit a certain clinician profile in one of the smallest initial markets in Australia, and then now kicking that off in the U.K. And we have a whole roadmap expanding this one tightly-defined customer segment at a time. So a huge market, we are barely scratching the surface of it. Next question. Regarding the press release for the clinical studies on MetaPanel and results for inflammatory bowel disease patients experiencing a flare, what could these results mean for MetaPanel sales? Well, to best answer that, let's step back for a second. So the state of care and management for inflammatory bowel disease is unfortunately not great. For inflammatory bowel disease patients, every flare brings a fear and a range of questions. Will it pass quickly or is this going to just spiral out of control? Will it mean an escalation to stronger medication, and what are going to be the side effects or impacts of that? And the most haunting one, is this the time that I end up in life-altering surgery with a bowel resection? There was actually a recent whole State of the Nation report on IBD released by the Federal Health Minister, Mark Butler. So 180,000, I think, patients in Australia, 7 million patients globally. One potential outcome is that this will ultimately lead to a complete change in the care model for inflammatory bowel disease, where MetaPanel is used as a standard of care for all patients experiencing a flare to detect a potential pathogenic cause of that flare, which would enable the avoidance of side effects, of unnecessary therapeutic escalation, stop unnecessary escalation to surgery, potentially enhance responsiveness to inflammatory bowel disease therapies, and ultimately significantly improve patient outcomes. So to answer the question, it could have a material impact to sales, as this messaging gets into market and impacts clinician behavior. Next question here. Taking a first step into the U.S. market is exciting, but it's also expensive and highly competitive. So how do you plan to mitigate risk and be successful where many have failed? As I said before, it's a big pie, and so we're going to take that one slice, one bite at a time so it's digestible. As I said, one state, one city, one metro area. Get in with a minimal operational and sales team. Execute our closed group, early access program with influential clinicians, proof that we can sell. Generate the referral rates that we expect and retain customers. And then expand from there. So precision, one bite at a time, and expand aligned to sales and revenue traction. That's the strategy. Next one. What's the update on U.S. reimbursement? So I'll recap on a bit of what I said before. And actually, I said in the recent diagnostic deep dive that we've done an immense amount of work on U.S. reimbursement. I've got a 200-page document on all of the work that we've done here, with some of the best advisers that we could possibly have. The strategy is focused on Medicare reimbursement before we go on to private payers. But importantly, as I said before, reimbursement is an accelerant for us, not a barrier to entry. So unlike many traditional diagnostics where you really don't have a market until you have reimbursement, because of the standard of care here with these patients being so poor and that leading to so many chronically unwell people not getting a solution, paying $500 for a test to potentially get a life-changing new answer and resolution is acceptable and viable for a good slice of the market. So rather than reimbursement being a hard barrier to adoption, it really is an accelerant for us: increases speed of adoption, opens up more of the market. So we will continue to deliver life-changing results for patients unencumbered by reimbursement, very happy to pay out of pocket, with a significant portion of that market being in that position. And in parallel, we'll execute a reimbursement strategy which will supercharge that and then just put wind in the sails of the growth team. So that's the strategy. Next question. Pleasing to see the partnership with the Colonoscopy Clinic. Is there the opportunity to do more partnerships like this? And what impact could that have on growth? So the team at the Colonoscopy Clinic and Integrated Gut Health Clinic are world-class. The work that we're doing with them, we expect, will not only immediately impact a lot of patients. In fact, it already is. But we expect could be seminal for the field in advancing the gastroenterology care model into a more precision model supported by our tests. And to answer the question, I think this is just the first example. Every country, every state, every city should have one or more of these. And the team are active in finding and engaging them. So this is just the first great example of how we can engage in that way. Next question here. With the transition for Microba's therapeutics business, what does that mean for the MAP 315 Phase II clinical trial? It means it will happen when the non-dilutive funding is one to execute it. We won't use our existing funds and balance sheet capital from Microba, and we're not planning to raise new funds and dilute shareholders to do it. We have multiple activities underway to win the funding we need without diluting shareholders, and so that's our focus. That's our strategy. Next question here. Having completed the allergy discovery program with International Flavors & Fragrances, what do we expect would happen next with them? And how does that fit into the next-generation probiotic stream for the therapeutics business? From my perspective and the team's perspective, that $79 billion probiotics market is on the edge or precipice of a major transformation. So you look at all those products on the shelf, typically say, right idea, wrong organisms. So what we're expecting to see, and the science supports this, is a move from what has been largely food and environmental based organisms that are not natural residents of the human microbiome into human-derived organisms that are natural residents of a healthy microbiome. And with the pool of data, our biobank assets and now our Supplement commercial capability, Microba is in a really strong position for this next-generation probiotic opportunity, to partner and bring these assets to health care professionals, patients and consumers across the globe and be a major part of this disruption to this $79 billion probiotic category. So the commercial focus of this stream is putting together structured, what we call pay-to-play, product development and commercialization programs leveraging all of our expertise, capability and IP, and where possible, leveraging non-dilutive federal and state ground-based funding. And as you called out in the question, we've already made great progress here. Microba has already engaged the largest probiotic manufacturer in the world, IFF. We have just recently completed our multistage discovery program to develop novel microbiome-based treatments for multiple forms of allergy and naturally engaging them around next steps. So stay tuned. Next question. What is Microba doing to stay ahead of the curve when it comes to using new artificial intelligence techniques? Multiple things. We have staff using multiple AI models across the business, all the way from business intelligence reporting through to marketing content. In our software engineering team, for example, they're using multiple AI models to advance coding efficiency. But we are actively building an AI strategy with the intent to have us at the forefront of AI integration into our product and service. And that contemplates everything from customer service agents through to report, results and interpretation. Perhaps like one example, we did some work where we developed an internal AI tool, which we called Sally, to support the team to produce our expert summaries that sit at the top of the report. They're historically done manually by our internal team of trained clinicians and pathologists. But by trialing Sally together with some other smart approaches, we created a solution that significantly reduced the time to produce those expert summaries at the top of the report just down to a couple of minutes. And in the recent Board meeting, I'll share, we discussed specific resourcing dedicated to our AI strategy. So we treat this as very important. And I believe we've got to be at the front of the pack here. And we have an incredible data position to enable us to do things with AI that others just simply can't. So data is key here, and we have the data. So that closes the quarterly results and the submitted questions. So for those that know the story well, feel free to check out.

And now for anyone new to the Microba story, stay tuned in and I'm going to do a recap on the business. And that starts with: What is Microba all about? Let me start by sharing an often unknown and surprising fact. And that is that your body is home to trillions of tiny microorganisms. And these tiny organisms are essential for your health. In fact, they are so essential that there are now more than 21,000 studies showing that they are key to how we develop and can treat chronic diseases. Important to call out, most of them, about 95%, live in your gut. And we call this ecosystem of organisms your gut microbiome. So that, I hope, puts into context everything that I've just said in the last half an hour or so. Now, what are we targeting with all of this? Well, chronic diseases affect 6 in 10 people. They include everything from cancer, depression, diabetes [ through the bowel and heart ] and many other diseases. But the exciting insight here is that there are now over 150 studies demonstrating that if we change these tiny organisms in our gut, we can improve and even treat these chronic diseases. And from this, Microba's vision is very clear, that testing and monitoring your gut microbiome is going to be a routine part of health and disease management with your doctor, and that novel microbiome therapeutics are going to be developed, commercialized and routinely used to treat chronic diseases. And now if taken together, that microbiome diagnostics and therapeutics here indeed play a meaningful role in supporting these patients. This could ultimately be worth more than $1 trillion. This is a huge market opportunity. Now I recognize that's a big state. So rather than just believe me, you can just look to action and look to the action of the giants in the space of medical diagnostics who also see this opportunity and have come to Microba and partnered with us at the forefront of this field. We've got a few of those. One of those is Sonic Healthcare, a global diagnostics leader and one of Australia's largest and most trusted health care companies, who believe this so much that they became not only a major partner, but a major shareholder. And here's the quote from their CEO, Colin Goldschmidt stating the thesis aligned to their strategic investment in us. So let's dive into the diagnostics business. We are in a leading position at the forefront of clinical microbiome diagnostics. And with the central impact that the microbiome plays in a range of diseases, there is a lot of opportunity here. Importantly, we've got to solve one thing well first. Today we are laser-focused on applying our technology and team to help patients suffering from gastrointestinal disease. Why? Well, 95% of those organisms live in your gut. They act there first before they act systemically on other parts of the body. And it's a ginormous market. So 37 million people are, every year, in the U.S. alone, seeing a doctor with these gastrointestinal issues spanning from severe diarrhea through to bloating, pain, irritable bowel syndrome or inflammatory bowel disease. And it is a huge unsolved problem. So looking at the chart on the right, historically, only half of these patients suffering have achieved a resolution. So how do we help these patients? Well, many of the answers lie in their gut microbiome. So to address that, we've developed 2 tests: MetaPanel for diagnosing gastrointestinal pathogens, which launched just us last year in Australia with Sonic Healthcare; and MetaXplore for diagnosing gastrointestinal disorders, which launched just the year prior. Now our real-world data here has shown that, with our tests, we can get critical new diagnosis and treatment recommendations for over half of those patients, 52%, who have previously had no path to a resolution. So that's massive. We're very proud of the impact that we're already having on these patients, and we are only just at the start of this journey. So what's this first opportunity in gastrointestinal disease worth? It's a big market. We did some really great work with a Boston-based consulting firm and estimate that the first -- just the first slice of what we define as this new major diagnostic category in clinical microbiome testing, just taking the first slice of that in gastrointestinal disease alone could be worth well in excess of $25 billion. I'm going to, in the interest of time, skip a couple of the testimonial slides here. We have patient testimonials for people getting answers and resolution to GI symptoms that they've been suffering from for 10, 20 or, in the case of this patient, for 35 years, now completely resolved. So perhaps then not surprising, we are seeing strong sales and growth and it's accelerating. So this is a huge market with millions of patients suffering every day. And as I said before, we are just getting started. So now to dive into our therapeutics business for a moment. Microba is in a prime position at the forefront of microbiome therapeutics. And again, our primary focus is on gastrointestinal disease, specifically inflammatory bowel disease, which is a $23 billion treatment market. We have a drug development platform, enabling us to deliver a pipeline of novel microbiome therapeutic assets. And we have successfully completed a Phase I trial for our inflammatory bowel disease lead candidate, which we call MAP 315, showing it was safe and well tolerated, and have now done significant preclinical and early clinical derisking, which leads to our focused partnering and non-dilutive funding work. So after what I said before of 5 years of R&D-heavy mode to develop these assets, we've now been able to shift into an R&D-light, capital-light and partnering-heavy and revenue-focused mode. And so there, we have 2 commercial streams to value returns, which stream one, live biotherapeutics, so traditional drug route disrupting and advancing the care for a range of chronic diseases. And stream two, that next-generation probiotics stream, disrupting that $79 billion robotic market with new, novel, healthy human-derived products. And so what could assets in those 2 commercial streams be worth? So I've obviously put some indications there on the right based on previous precedent deal activity. But just to give you a little bit more air time, looking at recent transactions in inflammatory bowel disease, the appetite from big pharma in this category is strong, with 5 recent deals valued between $1.5 billion to $11 billion. And then if you look at recent activity in next-generation probiotics, you can see that things are heading up. So hope that gives you an idea of the size and scale of the opportunities there with our therapeutics work. So on that, I'm going to close, as I always often do, in saying I'm incredibly excited about the opportunity, the impact and growth ahead for Microba. We have an incredible world-class team, best-in-class technology and category-defining products, for patients we're already changing lives, and there are a lot of patients that need our help. So thank you all for listening and for your ongoing support.