Microba Life Sciences Limited

morning everyone. I'm very pleased to share an update on our progress following close of the quarter ended 30 September 2024. This is our standard disclaimer. Now let me start by taking you through the strong numbers from the quarter. We delivered $3.65 million in revenue which is up 239% year-on-year and $5.07 million in cash receipts which is up 184% year-on-year. Importantly, we saw continued strong sales momentum for MetaExplore in Australia. Test sales up over 100% year-on-year, ordering clinicians up over 80% year-on-year, giving us an annualized run rate of over 7,300 tests and a strong start to Q2. With October, as at the end of last week, Friday the 25th, having already set a record sales month with a week left to go before we even finish the month. In the United Kingdom, we saw sustained growth in supplements up 3.6% year on year and relatively flat ordering clinician numbers year on year in line with the UK summer holiday period. And we weren't surprised to see testing sales down temporarily in Q1 with the UK summer holidays and our intentional focus on the team on preparations for meta explore access into the UK. And pleasingly, testing sales have already recovered as of the 25th of October with sales ahead of September. And aligned to that focus, the team have successfully launched an early access program for Meta Explore to key clinician accounts in October with first orders already flowing in. And aligned to this, we doubled the size of the sales force, setting up for growth and Meta Explore full access in the UK in 2025. Pleasingly, during October, our testing business is trading in line with expectations with both testing and supplement sales ahead of September back in line with non-summer holiday months. Now, Q1 traditionally is our soft quarter of the year due to school holiday periods in both northern and southern hemispheres and revenue recognition for service contracts, which typically conclude in Q4. So the key is to look at the PCP growth as that compares similar periods and takes out that seasonality. So as you can see, the PCP or year-on-year growth is compelling at over 239%. Noting that MetaExplore sales have now commenced in the UK in October, together with a doubling of the UK sales force, and we expect to see this translate into UK testing revenue growth in the second half of the financial year. 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 covering our continued momentum in Australia with our diagnostic tests, Meta Explore and Meta Panel, our progress in the UK transitioning to unlock growth in that region with the launch of Meta Explore, advancement of our therapeutic assets and strategic appointments to accelerate our growth. And I'm going to start there. So with the momentum of our diagnostics business, we've bolstered the team in key strategic areas aligned to our growth strategy. We've been carefully building a team of top tier talent, bringing on what I call true 10 Xs. And one excellent recent addition is Eric Davis, who's joined us as chief growth officer to spearhead our global go-to-market strategy. Eric has a phenomenal track record in the healthcare industry at Abbott, He was pivotal in developing and commercializing Freestyle Libra, the continuous glucose monitor, which has revolutionized diabetes management and become one of the world's top selling medical devices, generating over 5 billion in annual sales. Eric then got poached by Cochlear, which brought him to Australia. And we're absolutely thrilled to have attracted him to Microbar to lead our global strategic growth initiatives. Another world-class addition to the team is Chris Saab, who joined us as Chief Product Officer, an incredible proven product leader. He was a critical product leader at Uber, where he was in the trenches with founding CEO Travis through their critical growth years. He's now a globally sought-after advisor, and we've been able to attract him into Microbit to lead our product strategy, roadmaps, and rapid execution at the forefront of the clinical application of microbiome testing. The attraction of this calibre of talent is a real testament to what we build at MoCrobar and a clear sign of our conviction for future success and growth. In Australia, we're seeing continued growth and clinical adoption of MetaExplore. Over 1,800 tests sold for the quarter, up 100% year on year. Over 480 ordering clinicians for the quarter, up 80% year on year. And the Q1 results here clearly indicate that we're on track for another strong half of growth. And in support of that, we've had a very strong start to Q2 with October, as at the end of last week, on Friday the 25th, having already set a record sales month with a week left to go before we even finished the month, signalling a continuation of this growth in Q2. The team... at the moment are incredibly focused on a range of growth activities that are purposefully designed to continuing this growth momentum. Next, Metapanel in Australia. We're making good progress since launch earlier in the year. Doctor referrals and sales continuing to build across the country. And a key highlight from the quarter was a presentation of the product and clinical results from Associate Professor Mike Weyron from Douglas Hanley Moyer, which is Sonic Healthcare's New South Wales business. That presentation was at the leading gastroenterologist event of the year in Australia, Gastroenterology Week, also known as GISA. The microbe and sonic teams continue to grow our collaboration on targeted sales and marketing activities directed both gastroenterologists and general practitioners through a combination of field sales, clinician education, KOL engagement, and important clinical utility studies and publications. Next, our business in the United Kingdom, officially transitioning into growth aligned to execution of our clear growth strategy for that region. Again, ordering clinicians have been maintained as we prepared for growth, supplement sales are up, and we weren't surprised to see testing sales down temporarily in Q1 with our intentional focus of the team on preparations for meta-explore access in the UK. And this has already recovered with October trading in line with expectations and both testing and supplement sales ahead of September back in line with non-summer holiday months in the UK. Now, if you remember, the fundamental investment thesis of the in vivo clinical acquisition was the ability to accelerate Microva's entry of its world-leading meta-explore test into the United Kingdom through an established team and customer base. And there were two key components to our strategy. And I'm very pleased that with the team's focus, we are well advanced on the execution of that strategy that we laid out at the time of acquisition. So the first part was that the InVivo team had light resourcing in sales and marketing with less than one full-time resource in sales for a company generating almost $9 million in revenue. Stage one of the growth plan was to sensibly add some firepower to that and then get that new team educated on and ready to sell MetaExplore. And we've now done that with the appointment of a UK commercial director and the addition of field sales reps. Then stage two of the growth plan was the core thesis of the acquisition, that in vivo has a leading position in gastrointestinal microbiome testing for clinicians in the UK, and that by adding our world-leading test, we could multiply that business. And aligned to that, The team successfully opened an early access program to key clinician accounts in October and achieved first meta-explore orders, setting up for growth and full market access in 2025. For Microbe's therapeutic business, firstly, for inflammatory bowel disease program, we continue to advance to a phase two clinical trial to demonstrate clinical efficacy for our lead candidate, MAP315. Second, for our immuno-oncology program, we grew our clinical data and sample set to over 4,500 patients to support the preclinical package and our lead candidate selection process. And finally, for our autoimmune program, following successful completion of our two-year discovery program in partnership with Ginkgo Bioworks, we took our six therapeutic leads for that program through multiple preclinical validation models confirming their disease-relevant activity and further characterized them for manufacturability and for safety. So all moving forward aligned to the plan and we are well and truly at the forefront of drug development from the microbiome and the team are active in our global partnering efforts. So close the quarterly update here and then go to a deep dive on the business for those that are new to the microbus story. So to first close out the quarterly in our diagnostics, we are critically focused on growth in Australia. our launch and growth of MetaExplore in the United Kingdom and driving to reimbursement in the US. For therapeutics, we're laser focused on advancing to phase two and very active in our partnering efforts. As at 30 September 2024, we had $16.4 million in the bank with circa $6 million also expected to be received in this quarter for Microbe's FY24 R&D tax incentive claim. So I'll stop here on the quarterly and switch gears to recap and do a deep dive on the business for anyone that's new to microba. To explain what microba is all about, let me start by sharing a surprising fact. Your body is home to trillions of tiny microorganisms, and these tiny microorganisms are absolutely essential for your health. In fact, they are so essential There are now more than 21,000 studies showing that they are key to how we develop and can treat chronic diseases. Now, most of them, about 95%, live in your gut. And we call this ecosystem of organisms your gut microbiome. Chronic diseases affect six in 10 people. They include cancer, depression, diabetes, bowel, heart, and many other diseases. But the exciting insight 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 chronic diseases. Microbius 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 at Microbah, we're already making both microbiome testing and treatment a reality. We are commercial stage and already generating revenues and grew over 120% last year. We recently launched two diagnostic testing products, opening up a $15 billion new diagnostic category. And we have partnerships with two of the world's largest diagnostic companies backing us to do this, Sonic Healthcare and SynLab. In parallel, We've discovered and developed novel microbiome therapeutics addressing an aggregate market worth over $50 billion, successfully completed a phase one clinical trial and advancing to phase two. All founded by two professors who wrote the book in this field and led by a world-class team. So diving into our diagnostics business, we are in a leading position at the forefront of clinical microbiome testing. And with the central impact that the microbiome plays in a range of diseases, there is a lot of opportunity. But today, we are laser focused on applying our technology to help patients suffering from gastrointestinal disease. Gastrointestinal disease is a ginormous market. In biotech, cancer gets a lot of attention for good reasons. But there are a significantly higher number of people seeing a doctor with gastrointestinal issues, including severe diarrhea, bloating, pain, irritable bowel syndrome, or inflammatory bowel disease. In fact, every year, there are over 37 million of them in the US alone. But the real headline number is, 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 two tests, MetaPanel for diagnosing gastrointestinal pathogens, which launched just this year across Australia with Sonic Healthcare, and MetaExplore for diagnosing gastrointestinal disorders, which launched just last year here in Australia, and we've just opened up the first orders in the United Kingdom. Our real world data has shown that with our tests, we can get critical new diagnosis and treatment recommendations for 52% of patients who previously had no path to a resolution. This is huge and we're very proud of the impact that we're having on these patients. Safe to say this is a big market. This new diagnostic category is expected to be worth well in excess of $15 billion in the US alone. I'll skip over. a couple of the testimonial slides here, but 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. Perhaps then not surprising that we're seeing strong sales growth and it's continuing to accelerate. This is a huge market with millions of patients suffering every day, and we're just getting started. Now to deep dive into our therapeutics business. Microbar is also in a prime position at the forefront of microbiome therapeutics. 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 therapeutics. We have successfully completed a phase one trial for our inflammatory bowel disease lead candidate MAP315 showing it was safe and well tolerated and now rapidly advancing to a phase two trial. Looking at recent transactions in inflammatory bowel disease, the appetite here from Big Pharma in this category is strong with five recent deals valued between one and a half to 11 billion US dollars. So I'll close by saying I'm incredibly excited about the opportunity impact and growth ahead for microbar. We have an incredible team and we've just bolstered that with some additional top tier talent to continue our growth trajectory. For patients, we're already changing lives and there are a lot of people that need our help. So thank you all for your ongoing support and I'll close here.