Ondine Biomedical Inc. (OBI) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Ondine Biomedical Investor presentation. [Operator Instructions] The company may not be in a position to answer every question received during the meeting itself, however, the company can review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Nicolas Loebel. Good afternoon, sir.

Good afternoon. Thank you so much, Lily. Thank you to all investors and attendees of our midyear results corporate update for 2024. We start by reminding folks on this call that every year, there are 9 Wembley Stadium full of people who get a hospital-acquired infection. This is a horrible statistic. This is something that shouldn't be there at all. There should be zero hospital-acquired infections, but they are unfortunately a fact of life in today's world. And those infections are so significant that they produce an enormous added burden to the cost of health care. And this is in all countries. But in the U.K., you're looking at a GBP 2 billion-plus expense and over 5.5 million bed days utilized for these infections. Put that in context, we have a 6 million patient waiting, backlog of folks in the NHS, the longest in history. And to double that with another 6 million days needed to treat these infections is a really serious problem. We need to get on top of this. And unfortunately, the current approach, which is using empirical antibiotics, isn't working well as resistance starts to cut into the effectiveness of antibiotics. So you can see that on the screen, we can show that the average hospital budget is spending about 6% on the cost of these deadly adverse events. Okay? This published HAI rate can vary from, let's say, 3% to 11%. But you can see that the cost is in the billions. And this affects every health care system and every hospital from the small to the medium to the large. We've developed an approach that really seriously impacts this infection rate. And the approach involves disinfecting the patient's nose before they go into surgery. Those of you who've listened to me before have heard that this has taken over $200 million and almost 20 years to develop. The particular format that we currently sell in Canadian and other hospitals were regulated and approved in 37 countries now is on the screen where you see the [ popule ] on the top right, a small swab, which is pre-saturated with a photosensitive solution. This is a solution that is benign until it is spread onto a surface on which microbes have colonized. And then, we illuminate it with light from a laser. That light is red. It is the appropriate power. It is the appropriate time, and that light activates the substance that's in that photosensitizer. That activation causes lethal kill to bacteria, fungus, and virus, but it doesn't harm human cells. There's a charge-based interaction with human cells, which doesn't occur in the way it does with microbes. So that kill is extremely rapid. In about 5 minutes, we can take a patient from heavily colonized with MRSA, for example, that's the drug-resistant form of Staphylococcus aureus, that causes the most intensively difficult-to-treat infections. You take that patient to effectively zero colonization. Let's say, 99.9% -- sometimes 99.99% decolonized in that space over only a few minutes. And imagine what that does to hospital workflows, imagine how that opens up the opportunity of a hospital to treat patients. Instead of relying on a 5-day course of antibiotics in the nose, twice a day, which most patients will not comply with, also to which bacteria are often resistant. So rather than focus on all the negatives of antibiotics, let me just tell you how powerful this treatment can be. In a year of deployment in some of the largest Canadian hospitals, we've seen 50%, 60% and 70% reductions in infection rate. Imagine what that does to the pharmacoeconomics of the bottom line of a hospital only operating at a 6% or 8% gross margin. So this is a proprietary technology. It's protected by 70-plus patents. We have deployed it now for a number of years in Canada, and we're starting the deployment elsewhere. If you've been reading the press releases from Ondine, you'll know that we have now deployed within the National Health System, several hospitals have deployed. Others are now involved in the introduction to the system and are considering deployment imminently. We are at the commercial stage in the EMEA, and we're going to tell you about an exciting new development for our company, and that is the partnership with a large Swedish firm called Mölnlycke Healthcare, and that occurred post period, but it's so material that we insisted to keep that into this presentation. As always, our U.S. clinical partner is HCA Healthcare, a company with more than 300 hospitals and surgery centers, are representing themselves 5% of all U.S. hospitalizations and 15% of the U.S. hospitalizations as their group purchasing organization Health Trust and their 1,600 hospitals is involved. That company had $65 billion in revenue in 2023. And you can imagine with that number of hospitals, how much of an impact we could have on reducing costs and patient morbidity, of course, in surgical site infections. We are traded on AIM on the symbol OBI. Talk a few minutes about Mölnlycke and Ondine. We have joined forces against HAIs, and that headline is carefully considered. Mölnlycke is a perfect fit for Ondine, and we would like to think vice versa. Mölnlycke is a company with almost EUR 2 billion in revenue. They're commercialized worldwide. Most of their commercialization activity is direct. Some is through distribution. They have 8,000-plus people and 100 countries into which they've commercialized operations involved in wound care, in surgical specialties and gloves and antiseptics and so forth. The operating room solutions group, et cetera, have enormous impact. You may remember or recall that Mölnlycke is the purveyor of the Hibi franchise, more than 10 million patients annually get disinfected using one of their Hibi gluconate products, Hibiwash, Hibiclens, and so forth. The Hibi franchise is very powerful, very, very venerable. It's a well-understood product, well accepted by hospitals, and it is designed to decolonize the surface of the body effectively and quickly. But Mölnlycke, we're looking for a solution to the problem of microbes in the nose because that's quite difficult to solve. You need to have a technique which is acceptable from a safety standpoint, fast enough to be acceptable from a hospital, workflow standpoint, one that is not resistance forming, certainly one that is broad spectrum, so that you don't have to do the testing for which antibiotic to use on a patient. Just decolonize them all. And they found what they were looking for in Ondine, and we have put together a joint venture, a collaboration agreement, which has taken us 1 year of careful and detailed negotiations to put together. The companies have visited each other at their headquarters, and we will shortly be hosted by Mölnlycke in their Swedish facility as well. So we're very excited about this opportunity because Mölnlycke really represents for us an ability to focus on what we're good at. We develop product, we test the product, we clinically trial the product. We're very good at creating all of the components required under quality managed approaches. But when it comes to selling, we have been very successful with a single salesperson. We've proven that it can be done. We've proven that the product can be moved into major hospitals. We'll be at 29 hospitals at the end of this period, and that's the first half alone, growing rapidly. Our revenue, as you will see, is growing 100% per annum, doubling per annum. And what we will rely on Mölnlycke for is that go-to-market strategy. And in fact, we can see that the 2 companies have complementary strengths to accelerate the adoption of photodisinfection. It's not just the extraordinary good faith vouchsafing that they are doing. The fact that Mölnlycke has done such careful due diligence, have looked through all of the studies, have evaluated carefully all of our products, our production, our supply chain, our documentation, our post-market surveillance systems, but they see the future and their future is in growth. And the growth mindset at Mölnlycke is such a complementary feature for us. Because to get where we need to go, which is to dominate topical disinfection. In every hospital, in every clinic, we need to have a strong clinical partner. And in the U.S., HCA Healthcare is helping us with the clinical side of the business. They're not a direct sales organization. We may or may not work with Mölnlycke in the future in the U.S. The transaction that we did with them involves the rest of the world. And it is a relationship that we're very proud of. Obviously, Mölnlycke sales reach is something that we're counting on. They will be putting a direct sales force to work solely for Steriwave, the product in the U.K. as well as utilizing other members of their surgical specialties and other groups who will be co-selling the product as well. So we're looking for a great first year starting in January in the U.K., selling to the U.K. hospitals that Mölnlycke is in, and has been in for a number of years. Mölnlycke have a great business in the U.K. And then quickly thereafter, expanding to other countries. You will see this is a carefully considered rollout, just moving the product into the Mölnlycke Healthcare system, getting it set up logistically and so forth, is the work of the next quarter. And thereafter, you will see the rollout looking at those kinds of opportunities on the screen. So a total across all countries of over 6,000 hospitals, 12.5 million major surgeries and over $1 billion (sic) [$1.1 billion ] in TAM, and that's the U.S. total addressable market -- U.S. dollar total addressable market. Note that this does not yet include the U.S. We certainly anticipate that we will be working with Mölnlycke in the U.S., but we're going to collectively evaluate how it goes over the next year to 2 years as we see this product rollout into these countries. And you'll notice that in the first wave are a number of important countries which do suffer from higher infection rates and have the medical system and the medical mindset to want to combat this problem. Which brings me to the U.S. and one of the most important undertakings of Ondine in its entire history. We are ready for our Phase III study. We have our clinical trial agreement, and it says agreement, but I'll say agreements, many of them signed with HCA. Our clinical research organization is on board, and we are engaged in finalizing the site selection. You'll notice on the slide here, I may be able to draw, but I'll just point if you see that, and that is 14 sites and 5,000 patients expected on this study. And that's something where we believe we will provide for a remarkable clinical outcome, where in a large number of patients with comorbidities that would otherwise range from highly disfiguring all the way to death with a high death rate and certainly with lengthy time spent in the hospital, occupying beds, requiring all companies who are involved, not just HCA, to spend time with revisioning that patient, seeing a great pharmacoeconomic benefit. We're looking for one primary endpoint, which is the reduction in infection rate. We have HCA providing all clinical sites. HCA is also providing us with a highly, highly cost-reduced approach to the study. We are extremely grateful, and we repeat this every time we can at the heavy lifting that HCA is doing for us. This cost-reduced study is the reason why our small company can afford to do a study that will hopefully end up published in some of the most important journals in the world and become a landmark study in the impact of photodisinfection on the reduction of surgical site infections. We have provided for medical endpoint adjudication committees. Key opinion leaders have joined to do the monitoring as well as internal monitoring. FDA is fully integrated into the study design. In fact, that's a reflection of their requirements. You see on the screen how the treatment arm is half the study initially with the control arm the other half and then the treatment hospitals become the control hospitals. And after a short washout period, 6-week washout period, we repeat the study with the sites switched over. This is the strongest statistical study design, the one with the most impact, the one with the least bias that we could design and the FDA certainly agreed with that. Only a 30-day follow-up, presence or absence of an infection, and we expect recruitment to be complete in 2 to 3 months on each side of the study. So again, a study that only will take 6 to as much as 9 months to complete. No long-term follow-up. This is not a long-term cancer type study. This is a short follow-up study. And the endpoints will involve both looking as a primary endpoint at post-surgical infection rate and a secondary endpoint at the reduction in microbes. Please recall that after 250,000-odd patients that have been treated in Canada using photodisinfection by Ondine, we're very familiar with the outcomes of such studies, and we believe the study to be substantially derisked. And it's on that basis that HCA and the other stakeholders have moved forward to determine finally in an FDA protocol, a Phase III study that will ultimately result in approval. And we expect that that approval should occur within a period of time that is faster than most because we are a fast track and QIDP company. But there's been another exciting development for Ondine in the recent past. We have constantly been engaged by hospitals with interest to deploy photodynamic disinfection in the nose in the critical care environment, so in the intensive care unit. Why? Because those patients suffer from extremely dangerous infections. These patients have a 30% mortality rate, and that is far too high. There are far fewer of them going into an ICU than going into surgery. But when you look at the fact that the patients must be decolonized once a day versus a single treatment before surgery, you actually get to approximately the same impact factor from a revenue perspective and total number of treatments for each. So in one stroke, we seize the opportunity to decolonize patients in the greatest need and at the same time, double our revenue. These patients in ICU are sicker. They have a much higher mortality, and that need is unmet today by Mupirocin, which is the antibiotic that is used in patients. Why? A patient will transfer to ICU and potentially need Mupirocin without the previous 5 days required for that substance to work and other products have proven less effective. So we're extremely proud to tell you that we have established our second indication for use development already. We have been in discussion with Royal Columbian Hospital, one of the oldest hospitals in British Columbia and certainly with fantastic folks who know exactly what they're doing in the ICU. They have worked with us now for months to develop the study. And indeed, they're so bullish that they've agreed to conduct the entire study on the basis of a share exchange agreement, so services for equity rather than for precious cash from our treasury, which is being devoted towards the Phase III in the U.S. You'll see that our design here is a 4-month pilot, which informs the development of the primary multicenter study, which is up to 2,000 patients. And again, we will be looking at infection reduction, but some things that are very important in the ICU, length of stay impact, many thousands of dollars a day to stay in the ICU and length of stay even by a single day is a really important outcome. Obviously, the mortality impact. And we have some data in this regard, from previous studies, which indicate that we will be successful on those endpoints. This supplemental indication will now permit once approved for direct marketing in Canada, we will then bring that into the EU and provide the FDA with the data for a supplemental study also to be done with HCA in the U.S. A few words about our commercial momentum as this is a results presentation. Very proud to tell you that we maintain our doubling of revenue. That's commensurate with almost 200% year-over-year growth in hospitals. You'll notice that we were at 10 hospitals in the first half of 2023. We are currently at 29 hospitals, and that's just in the first half, and we're growing quickly. So you can appreciate major hospitals are now deploying the system. We've had some of the fastest expansion within existing hospitals that we've seen in the company's history, the most recent being the same day, deployment within one area of the hospital resulted in request for deployment in other areas. As I mentioned, we're listed on the NHS supply chain, which allows Mölnlycke now to roll out the product into the U.K. We've seen our first hospitals deploying in Spain and Australia. And we have now designed and roll -- started the rollout of our next-generation hardware, which is a cost-reduced and more efficient approach to our current fiberoptic hardware that we've used, the legacy hardware that we've used for years. That development is something that increases our gross margin, improves usability, improves outcomes and is something that we can manufacture in high volume. So when we're looking at large clinical deployments through strategic partners, we need to be able to have manufacturing that is commensurate with that demand. And so within the next few years, we are bringing into a production line something that can be built every 20 to 30 seconds and not built every 2 to 3 minutes. And that's something consistent with the volumes that we expect in the future. Steriwave is now in many of Canada's largest hospitals. There are hospitals on the West Coast, there are hospitals on the East Coast and other provinces in between. And each of these produces outcomes which are consistent with our 40%, 50%, 60% and greater percent reductions in infection rate, reductions in number of bed days used, reductions in the readmission rates and certainly reductions in cost, all important in the Canadian socialized health care system. When you look at some of these hospitals, you realize that these are the culmination of a year of development, but now our sales cycle is dropping into just a very few months and in some cases, just weeks. And I think that is a testament to our existing sales operation with our single, most extraordinary sales executive and some sales management that truly have driven an extraordinary business and proven that this is something ready for worldwide expansion. Just like to take us through the financial progress in the last half. As you see, sales revenue increased by 100% -- 101%, so doubling year-over-year. That's driven by the new hospital adoption rate, as I said, of 190%. As of H1, there will be 29 hospitals using or having approved Steriwave versus 10 in first half of 2023. The same hospital sales growth via expansion into new indications is driving that revenue growth and also an increase in the average sales price of treatment kits, is also helping there. So both organic growth as well as expansion into new hospitals. Gross margin, you'll see that we were able to slightly increase that by 300 basis points due to new customers acquiring at that higher average sales price. And we have maintained a strong focus on bringing cost -- cost of goods down, and that's exemplified in our second-generation products. G&A costs is a 10% decrease versus the first half of 2023, and that's because we remain highly focused on finding and exploiting those improved operational efficiency measures and being disciplined with any discretionary spending. The R&D costs, a 51% increase, that's large. You saw that because we've commenced the start-up phase of the Phase III. We've had to produce a lot of the product that is going to be deployed into that Phase III. We've worked with HCA Healthcare and contract research organizations, which are costed into that figure to commence the patients recruitment. So that's been the big increase in R&D costs. And then, in our sales and marketing costs, as we start to evolve towards a Mölnlycke-led organization, we've significantly reduced that investment. We've streamlined the sales approach. We've developed a network of KOLs who are virally marketing for us. We standardized operations. We've dramatically improved efficiency. We work with consultants who help us in that regard. And the revenues we were able to double while the sales and marketing costs went down by half. In May of 2024, you'll see that we raised a gross total of CAD 6 million. And post period, we've raised an additional CAD 5 million. So the company is capitalized along with post-period, other financing that we're putting in place and have put in place. So that concludes the financial progress slide. And I will just summarize now to say, one, the strategic commercial partnership with Mölnlycke is an enormous catalyst for our company, a company that some of our investors have been with now for many years. We're looking at one of the most breakthrough moments in our history. As a global wound care leader, I think Mölnlycke represents an optimal partner for Ondine. They're the right scope, they're the right scale and they have the right mindset to do this job. We're ready to proceed with our U.S. Phase III trial with HCA Healthcare. We've talked about HCL Healthcare on this presentation as well as previously. But suffice it to say, a company that understands the benefit of what we're trying to do, understands the product has helped us co-develop it and is involved in allowing us to bring it to market inexpensively. We've maintained a strong operating performance, including both increases in the number of hospitals and in our revenue, commensurate with reducing our sales and marketing expense. And we are now expanding into new markets, both from an indication perspective. We talked about the ICU second indication that's going to be coming through our clinical studies shortly and indeed, with new geographies with first deployments in countries like Australia and in deployments that Mölnlycke will be involved in. It's incredibly exciting to be at the helm of this company and watch us evolve, watch your investment evolve into now hospitals and countries where we have never been, where we will not know the hospitals or the customers and where the product will now be deployed by a much larger organization with a much larger sales and marketing team and of course, the ability to expand worldwide. So I'd like to thank you for your attention and open it up for any questions.

[Operator Instructions] I'd like to remind you that the recording of this presentation, along with a copy of the slides and the published Q&A can be accessed by our investor dashboard. As you can see, we have received a number of questions throughout today's presentation. Can I please ask you to read out the questions and give responses where appropriate to do so, and I'll pick up from you at the end.

Thank you, Lily. Our first question, what makes Mölnlycke a good partner for Steriwave? Great question. We think that Mölnlycke represents, as I've said in this presentation, a good go-to-market channel for us, in that they understand surgical antisepsis very, very well. They've been in this market for many, many years. Their products are market leaders in their sectors. More than 10 million patients are treated with the AB franchise annually. And it is such a good fit to bring them an innovative nasal decolonizing product. One, because it is innovative and their mindset relates to this developmental mindset of innovation, growth, bringing best-of-breed products to patients. That's a Mölnlycke trademark. Their fundamental association when you look at hospitals, when we talk to HCA about Mölnlycke is high-quality products, products that are at the top of their respective pyramid. So from a partnership perspective for us with their global reach, with their larger organization and certainly with their willingness and interest to engage with us, we think they're a perfect partner. The next question is, of course, the converse. Why did Mölnlycke choose you? Well, I think that the answer to that question must be that we were perceived by Mölnlycke as being at the right stage for co-development of this product into its next higher volume phase. They've looked very carefully at our hospital growth. If you remember that this product was really launched into the teeth of COVID. And during the pandemic, we did not treat many hospitals because hospitals were shut down dealing with COVID victims, but we treated enterprise workers. We treated extracurricularly folks who looked for any means to destroy virus in the nasopharynx, and we were very successful at that. But post that, in the last 2 or 3 years, we've seen this tremendous exponential growth. And I think Mölnlycke understood that that represented a path forward for them into areas where we have much less likelihood of success because we'd be working at arm's length from Canada and the U.S. So I think they chose us because we are at the right stage. We have the right product. I think they understand that our franchise is willing to work within a Mölnlycke franchise. The 2 companies think similarly. The people that we have met from the sales and marketing folks to their M&A folks, to the folks who are handling all of their marketing are absolutely best-of-breed top class. And we really appreciate the fact that this has been a bilateral choice and a choice of partners who I think will make a very successful joint venture going forward. Can you share any feedback from the most recent discussions with FDA about the clinical trial? That feedback to the extent that I can discuss it is positive. FDA is affirmative. They're permissive to the design. They suggested it. They like the fact that there is no or very little bias possible to creep through the crossover study. The fact that we're permitting standard of care in the control arms. It doesn't matter what the hospitals want to do. Please bring your best foot forward, bring the worst patients, bring the other interventions that you'd like to have, we will beat them all. How do we know? Because we've done it now for a number of years in Canada, and we've seen all those interventions fail against the benefit of Steriwave. So we're very comfortable, and I think FDA said, great, do a great study, do a study that's adequately powered at 5,000 patients, do a generalizable study with multiple hospitals across the country, bring in all the covariants that you can, make this robust. And if you hit the p-value, you get an approval and open up what they said was not just a few patients selected from a niche indication like an orphan drug, but "millions and millions of patients." Next question, how are you going to pay for the ICU clinical study just announced at Royal Colombian? Right. As I mentioned, that is going to be on a share exchange agreement, share for services. And that's something that we truly value. First of all, it's an indication of incredible support from the hospital. They want to be the best partner they can. Secondly, we recognize that it preserves our capital for the U.S. Phase III. And so that will be on a share for services agreement. With the ICU agreement, you mentioned two phases of the trial. Are both phases funded under the agreement? So first part of the question, that is correct. Both phases are funded under the agreement. It is a milestone-driven study. So we will provide for equity as each milestone is complete. Second part of the question, what is the scope of the trials from a regulatory perspective? And third question, what additional work do you expect to need to do before full commercialization? Let me just point out that the indication for use currently is general. If clinicians want to decolonize the nose from a potentially pathogenic microorganism, they are permitted to use Steriwave in the nose. That has the advantage of breadth, but we are not specifically showing clinicians how this works in each specific area other than the quality improvement projects, which are now many and several in pre-surgical decolonization. So to specifically market to the endpoint of ICU decolonization, that requires an ICU study. And so we will be submitting these studies in support of a Health Canada Tier 1 regulatory approval. We will also package them up into the marketing submissions to the CE Mark and the UKCA mark. What additional work do you expect to need before full commercialization? Well, the product is the same. The protocols are different. The number of times they're used is different. We have data in humans as well as in preclinical work that demonstrates the safety of multiple administrations. But the main work will be packaging all of the data into the regulatory submission, which, as you might imagine, is large. But given the fact that we have it and given the fact that these studies will take a number of quarters to complete, we have the time necessary, especially as the FDA study gets underway and reduces the burden on our people in-house on a day-to-day basis. We will have the resources needed to provide that regulatory submission. But from an operational perspective, we just have to produce more product. And I think that's absolutely one of the most extraordinary opportunities we faced in many years. Next question. What are the expected costs of the P III trial and the subsequent FDA approval process? To the extent that I can give you precision there, we have been guiding for a number of years prior to this point that that clinical study will cost us in the USD 10 million to USD 12 million range, and that is precisely in the end where it's coming out. That's in part due to the fact that HCA has done such a great job for us reducing those costs. But USD 10 million to USD 12 million for that. And then, in terms of subsequent NDA submission to get to that PDUFA date, we will probably require another couple of million dollars, primarily external consultants, contract statisticians, clinical study report writers and all of the supportive information around it. Beyond that, we will then scale up for U.S. manufacturing. We're very familiar with what that will require. We will do our 3 batches and so forth, and we'll take it from there. All right. Those were the questions that I have. I just wanted to provide some closing comments, if I may, Lily?

Yes, of course.

Well, I'd like to thank our investors, not least our investors, certainly, our management teams and our incredible employees, consultants and all the folks around Ondine who've brought us to this day. The continued support is so appreciated. Ondine is its people. And in many ways, we have solicited and received unsolicited advice and guidance from our investors, which we truly appreciate. We evolved through this moment, this breakthrough moment with Mölnlycke, and we look forward to really developing something that will start to change the face of health care as we predicted we would do. And we look forward to the Phase III study initiation with HCA and then, of course, seeing how we evolve into the new indications in Canada and maintain the funding momentum. So please don't hesitate to contact me directly or any of our management team. If you have any further questions, we'd be happy and excited to answer them. And thank you again for your attention on this call.

Nicolas, thanks for updating investors today. Can I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete, and I'm sure it'll be greatly valued by the company. On behalf of the management team of Ondine Biomedical, we'd like to thank you for attending today's presentation, and good afternoon to you all.

Thank you.