TSE:MBX Microbix Biosystems Q2 2026 Earnings Report C$0.23 -0.03 (-9.80%) As of 03:46 PM Eastern ProfileEarnings HistoryForecast Microbix Biosystems EPS ResultsActual EPS-C$0.01Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AMicrobix Biosystems Revenue ResultsActual Revenue$3.38 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AMicrobix Biosystems Announcement DetailsQuarterQ2 2026Date5/14/2026TimeBefore Market OpensConference Call DateThursday, May 14, 2026Conference Call Time10:00AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress ReleaseEarnings HistoryCompany ProfilePowered by Microbix Biosystems Q2 2026 Earnings Call TranscriptProvided by QuartrMay 14, 2026 ShareLink copied to clipboard.Key Takeaways Negative Sentiment: Q2 results were weak, with revenues below the company’s breakeven level and a net loss, driven mainly by lower sales to China and a soft quarter for QAPs. Neutral Sentiment: Excluding the China distributor decline, the company said the rest of the business grew 13% in the quarter, while management emphasized that new large customer opportunities are building. Positive Sentiment: Management reiterated that the balance sheet remains strong, with CAD 8.1 million in cash and expected quarterly cash burn around CAD 1 million including debt repayment, CapEx, and share buybacks. Positive Sentiment: The company said its operational capabilities and capacity have been significantly expanded, supporting large audits from major customers and positioning Microbix for larger-scale business wins. Positive Sentiment: Kinlytic remains on track toward a supplemental biologics filing in 2027 and a market launch in 2028, with management describing strong demand potential and ongoing manufacturing/validation work with Sequel. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallMicrobix Biosystems Q2 202600:00 / 00:00Speed:1x1.25x1.5x2xThere are 4 speakers on the call. Speaker 100:00:00Call. I have Cameron Groome, CEO, Ken Hughes, COO, Jim Currie, CFO. I'm not sure if we're gonna work off a presentation today, but as always, this session will contain forward-looking statements. If you'd like to know more about those, you can find them on the presentation on the company's website. There will be a Q&A section, so feel free to enter any questions you have in the Q&A box. With that out of the way, I'd like to turn the mic over to Cameron. Hi, Cameron. Operator00:00:28Good morning, Deborah. Thank you so much. Good morning, Ken and Jim Currie. I just want to thank everybody on the call for joining us for this update call this morning. As everybody will have seen from our results in Q2, it's not a particularly pretty quarter. The revenues were well below our engineered breakeven point, which is about CAD 5.5 million a quarter of revenues. Not unexpected to show a net loss, we are continuing to control our costs well. You know, net losses are not what we get dressed up in the morning for, you know, even if controlled. Operator00:01:12Some of that, and I'll ask Jim to speak to any specifics and address particular questions, but we have continued, of course, to see lower year-over-year sales into China, and that's a principal driver for the year-over-year comparability. We also saw some, as we normally see in Q2, is not a strong quarter for our sales to the proficiency testing and external quality assessment agencies, so our QAPs products. We did see some antigen sales that we'd aimed to land in Q2 delayed until later in the year that weren't made up by QAPs programs just due to some continued client delays. It's a bit frustrating, and it doesn't reflect the level of effort and fine work that we're doing, exerting on now looking to secure new business. Operator00:02:15You know, if I reflect on where we'd hoped to be at this point, we're probably, we're certainly well behind that level. You know, it took decades to get this business to CAD 10 million in revenues. We've been adding to our capabilities considerably, we're actually looking to bring back about CAD 10 million in revenues within 12 months of a couple of major client fall-offs. It's a steep hill we're climbing, and I think we're climbing it very well. We started with building capabilities for our business and broadening those out, modernizing the antigen production, bringing in the skills and capabilities to create our quality test control products, our Quality Assessment Products or QAPs. We worked successfully on building the capacity to produce those at scale. Operator00:03:18I think because of that, now we've really achieved the credibility as a result of both the capabilities and capacity we have successfully built. What we need to demonstrate, I think, now to investors is the league that we're actually playing in. I'm very confident that over the coming months, we are going to be able to demonstrate that. There are opportunities that we're pursuing that are at a scale that's unprecedented for our business that we can absolutely deliver on, and our prospective customers know that we have both the skills and the capacity to execute on that. These are opportunities that really dwarf anything we've seen so far coming into our company. We're very optimistic that we'll win that business now. Operator00:04:12As we look forward, we have to abide by our disclosure policies, which are, you know, we will only discuss specifics of opportunities when they are either secured by way of a firm contract agreement or begin to realize material revenues. We're really at the cusp of some of those developments, I believe, and that's definitely forward-looking information, so you know, you can't take that to the bank yet. These are the things we're working on and why we get up in the morning. We'll also talk about the ongoing work on our Kinlytic file as well, which is advancing well towards a supplemental biologicals licensing application filing. That is moving ahead as a value creator. Operator00:05:04We continue to have our business on the diagnostic side playing at the highest levels of industry now and working with many multiple large companies and driving value on that front, while we continue to, on a fully funded basis, advance a clinically and economically important therapeutics program. That's, you know, very much where we are. We are quite optimistic about what we're achieving, and we continue to have a strong balance sheet to be able to execute on that, notwithstanding the quarterly losses we've seen over the past few quarters. With that, maybe I can pass over to Jim to speak to any high points you'd like to call out about a quarter that's far from a high point. Operator00:05:57Ken, we'll then pass over to you for operations, and then Deb, we can move into any questions from those on the line. Speaker 200:06:07Great. Thanks, Cameron. Yeah, it was, as Cameron's indicated, it was a disappointing quarter. I mean, it's tough comparator to last year. I mean, we've been looking at our numbers, and last year, last year's first half was actually excluding Kinlytic license fees, last year the first half was the record half. It's been a tough comparator this year against that. A lot of that record was created by the distribution into China. That reduction in revenues of about CAD 2 million a quarter has had a significant impact on the business. Without that, we actually, in the second quarter, we actually grew the rest of our business, excluding our Chinese distribution, 13% during the quarter. There was some upside in terms of our performance to the quarter. Speaker 200:07:01Margins aren't where we want or targeting. Our target has always been in the 60-ish % range, which we achieved last year in the quarter. This year, lower volumes. We've got fixed manufacturing costs that we're absorbing within our lower volumes, that's leading to, you know, lower margins at this point in time, higher cost of sales. From a balance sheet perspective, still strong. Cash, CAD 8.1 million. Our cash burn during the quarter was about CAD 1 million, that's sort of where we see it over the next few quarters as well. Operator00:07:48Yeah. Jim, I'll just mention that you know, if we look at the traditional cash flow from operations or operating cash flow is about CAD 300,000. When we're talking about burn, we're also including capital investments, activities, and financial activities, including debt repayment and, you know, a prudent ongoing level of share buybacks. Speaker 200:08:12Yeah. On the cash front, I mean, while we have benefited from interest-free loans from FedDev over the last number of years to support the growth of our business, we're now in a position where we've started, during this quarter, to repay that debt. That's something new in terms of our cash spend that will occur over the next 5 years, as we've got 5 years to repay that no interest loan. CapEx, as Cameron said, we're not only our OpEx, but on our CapEx, we're trying to control spending, we're making investments in capital equipment where we need to. The nice to haves, we're delaying at this point in time. We're monitoring the spend. Speaker 200:09:11We're continuing to spend on our NCIB. We bought about 1.5 million shares at a cost of CAD 361,000. I think we believe that continuing that spend is important for the business and to help maintain our stock price level during a weaker time. Operator00:09:40Yeah. During an interval where, we're rebuilding, we certainly don't want to see a situation where anybody starts to get abusive in share price. I think I'll be looking at potentially at some further purchases personally, and that expresses, you know, our confidence in the business, not only individually, but collectively through the NCIB. Speaker 200:10:06Great. Kind of summarizing where we are right now, I mean, as Cameron Groome and I have both indicated, controlled spending. We're making sure we're investing our funds and spending our money in the right places. We have started to see some orders coming in from China. That's a good sign. We had budgeted to see that. I think we had budgeted to see that happening a little sooner. It is starting to happen now. Good outlook there. We're maintaining our capabilities. We wanna make sure that we keep the staff that we have today. We've got a strong employee base, and we've got growth expectations that are gonna require people with these skill sets as we move forward. We've indicated we've got the strong balance sheet, we've got the cash. Speaker 200:10:58We've had the cash to get us through and this hurdle at this point in time and to invest as we move forward. Ken, you got anything? Speaker 300:11:09Sure. I got plenty. The group knows we've been building operations for a while here. Cameron alluded to the fact that we're building both capacity and capability. In terms of capabilities, not, we started from a position of classical virology and pathology. We've added synthetic virology and pathology, and recombinant now capabilities here as well, which is a pretty unique portfolio of capabilities from a capability perspective. From a capacity perspective, we've been building semi-automated and automated procedures, scalability left, right, and center, really to give us the capacity and capabilities to support the growth going forward. That has not changed. Everything has been implemented and is operating extremely well. Speaker 300:11:59From an operational side, we continue to use operational excellence to increase yields in specific products to reduce costs and ultimately drive margins, and that's what we've been doing. We've been doing successfully. We're adding to our portfolio of QAPs. We're continuing to improve our antigens capabilities and going on from there. Our electronic quality management system is getting more and more sophisticated and more and more integrated, which is improving efficiencies and dovetailing nicely with our enterprise resource planning software. All the things we've said we're gonna do from an operational perspective are being executed where we have unique capabilities, I would say, and some global leadership in a number of areas, including QAPs and antigens and certain specific ones from within there, from within those portfolios. Speaker 300:12:48We have plenty of capacity to scale as these new opportunities come online. We're ready to go. I can't speak highly enough about the staff we have here, the scientific, procedural manufacturing, quality control, quality assurance. Even the finance people are quite good. We're doing really well from an operational perspective. I should have mentioned IT as well. We're really doing very well. I have nothing negative to say at all. We're ready to accept the opportunities as they come to us. That's great from an operational perspective. Perhaps a comment on Kinlytic as well. Kinlytic is moving forward as it should. Our relationship with Sequel continues to be strong. Scale-up and validation of drug substance manufacturing is underway. Speaker 300:13:32We're working with the drug product CDMO now as well. The timelines have not changed. We're moving forward. We expect material events over the next little while and submissions in 2027, building that market in 2028 as being disclosed. The relationship remains excellent. The scientific component is moving ahead. I think that's something that's very exciting for the future. Once we come back for the catheter clearance market, there are other markets to get involved with too. We're talking to our partner Sequel about those indications as well and whether or not we could bring some manufacturing component to Canada. That's again a forward-looking statement right now. Speaker 300:14:13We're working towards getting the supplement to the BLA filed and then start building the market for catheter management in the U.S., and then subsequently in the rest of the world, and that project is on schedule and on course. Operator00:14:27Yeah. Very good. No, thank you. Thank you, Ken. I'll just reemphasize, you know, this is, you know, major customers really need to see the capabilities and the both the capabilities and the capacity. If they're going to rely on Microbix as a critical sole source supply chain partner, we have to demonstrate all this. We have regular stream of major companies now coming in and doing multi-day quality systems audits of our capabilities and our capacity to ensure that they can trust us on these matters. We pass those with flying colors, and now have access to a scale of opportunity that would have been unthinkable a few years ago. Operator00:15:23That's not to give assurance we'll win that business, but it gives us assurance, you know, we are, certainly in our view, the best partner for such companies, and I think that's a view that they're coming to share more and more. You know, I'm increasingly optimistic that we'll be able to, at the, when the time is ripe, make some very interesting, very interesting business disclosures. Justified optimism. It's not naive optimism, but it's justified. And those of you who visited us see both the human resource capabilities as well as the technology and the infrastructure we have, to be able to deliver on these opportunities. And certainly, there's no slowdown in the technical advancements in the global diagnostics industry, whether that's on molecular diagnostics, multiplex tests, point of care. Operator00:16:22You know, all this is happening and being driven and we're really very much at the heart of it. You know, you'll see my reference to our logo in the corporate presentation where we're really at that intercept point between our customers and their target markets, and that's never been more true than it is today. Thank you. You know, not a financial quarter that we're going to be putting into the record books by any means, but I think this is turning out to be a really fun year. I'm very optimistic for the second half of this year from a fundamental developments and value creation point of view. Operator00:17:08I think that's probably a great place to leave it, Deborah, and maybe we can move over to questions. I see a few in the queue, and if you'd like to read those out, we'll do our level best to answer them. Speaker 100:17:23I had some via email, so I'll start with those ones. Operator00:17:28Very good. Speaker 100:17:29This antigen decrease was a result of a CAD 2 million reduction in sales to the company's distributor for China, believed due to reduced incidents of respiratory diseases requiring testing and tighter test access and reimbursement policies. I thought your sales to China for an entire year were CAD 2 million. Do they all historically come in Q2? Operator00:17:53No. Our, our sales in China in 2025 fiscal, were closer to, Sorry, 2024 fiscal, I should say. Thank you. I could see Jim's brow starting to furrow as he began to correct me. For fiscal 2024, we did about CAD 7 million into China in fiscal 2024, and we were on track to do north of that, and we're at CAD 8 million plus run rate through the first half of 2025, and that really fell off quite abruptly. I think we're you know, certainly speaking to our partner in, or that distributes into China for us, they're not exiting the market and they don't see it as gone. Operator00:18:37There was just a very abrupt slowdown in the incidents of walking pneumonia or white lung, as they called it in China, coupled with restrictions on people going to multiple hospitals or clinics and being tested multiple times. It's just, you know, as greater trust perhaps is being developed in that market, people were wanting to make sure the test they got was actually working and accurate, and doing tests, retesting. We've got a bit of a double whammy there, along with the normal cost control pressures that we see all around the world. That slowed things down, but we see as end users there, work through their inventories, we see reorders happening, and we're already starting to see that. It's not been at that high level. Operator00:19:35We were budgeting a little over CAD 1 million into China this year. I think we're below that level so far in terms of the run rate. I know we're below that level in terms of the run rate so far. We'll see when that comes back, and it could snap back as early as the fall, or that could push out a little bit more. Where the new normal becomes in China is the question. You know, do we look for CAD 1 million, CAD 2 million, CAD 4 million? You know, these are the questions we're trying to benchmark with our partners now. Is there another outbreak and it snaps back to a much higher level than that? Either way, we're ready for it. Operator00:20:17We can deliver on the volumes as may be required, but we're not counting on that as the big growth driver. Our big growth driver remains QAPs in the near term, nearer term, and Kinlytic going out at that 2028 timeframe that Kenneth indicated. Speaker 100:20:36So- Operator00:20:36Jim, did you wanna speak further on that, on that question? Deborah, do you feel we've answered it? Speaker 100:20:42Yeah, I had a follow-up, but Jim, if you have extra color, feel free. Speaker 200:20:46Oh, no, I didn't have any. I think, Cameron, you covered it correctly. I mean, I think we were seeing CAD 2 million a quarter for a period of, I guess, 6 quarters. That was not historically the level that we had seen in terms of revenues from China. There's no question. I mean, they really came up quite substantially in fiscal 2024. Prior to that, sales were probably in the, you know, CAD 2 million-CAD 4 million annualized with our Chinese distributors. We did see an uptick in 2024 and 2025, the first half of 2025. Operator00:21:21Yeah. That was not evident to either us or our partners or the manufacturers in China that that was going to be a temporary issue. It looked like there was an ongoing need for that testing, and nobody saw that slowing down as abruptly as it did. Speaker 100:21:41Is there seasonality in that typically? Operator00:21:44There is some seasonality in respiratory infections generally. It tends to be winter months. That's a tendency. It's not a hard line, you know. Sometimes you'll see, for example, COVID has now more of a fall incidence as there's a bit more of a back to school driver necessarily than a winter one. You know, we see some of the gastrointestinal infections occurring more in the spring and summertime. You know, food spoilage and camping and so forth. There's all these interlocking waves. As we continue to grow our business, we're seeing different sources of that volatility, and that, you know, we see that also evening out as we add additional large clients. Speaker 100:22:36The issue of titer test access and reimbursement, what has the bigger impact, that or reduced respiratory diseases? Operator00:22:49Tough to know exactly. I believe for us it is the incidence of respiratory disease more. We've also seen, we're also told there's been a consolidation of the number of test manufacturers has been reduced in China with a number of the more marginal players falling away. Speaker 100:23:11A follow-up question to that. Given the tight access and reimbursement policies, does that mean that even if respiratory diseases rebound, sales to China will be substantially lower than in years before the drawdown? Operator00:23:28Tough, tough to know. You know, the products we're selling into China are quite unique. You know, we are the global leader in the manufacture of those antigen products. You know, there's always a question, you know, is there a domestic manufacturer? I don't think there's anybody that has either the purity, the capacity, or the economics that we have. We're not, you know, we don't have marble fountains in the courtyard and gold-plated washrooms. You know, we do run a frugal cost base in our organization even though our science is excellent, as is our quality. I don't think there's a real ability to undercut it, or to deliver the same quality of product. Operator00:24:20People in medical devices manufacturing, you know, by definition should be conscious of quality as well. Speaker 100:24:28What, when will you know if your Chinese distribution partner will want to resume buying antigens for this year's? Operator00:24:35They already have, but at a lower level. Speaker 100:24:39Okay. Operator00:24:42you know, it's a question of inventory at three levels. There's inventory at the end user level, there's inventory at the distributor level, and there's inventory at the Microbix level. you know, we, as we see the latter two, the end user and the distributor inventories deplete, that's when our inventory gets pulled out. Speaker 100:25:02You've seen orders in both Q2 and Q3? Operator00:25:06Jim, when have we booked those orders? I'm just losing track here. Speaker 200:25:14In Q3. Operator00:25:14the current ones are Q3. Speaker 200:25:16Q3. Operator00:25:16Yeah. Yeah. Thank you. Speaker 100:25:19Moving on to caps. Have any of your large caps clients recently commercially launched their assays? Speaker 100:25:29soon to launch their assays? What's the expected revenue impact for Microbix at these launches this year and beyond? Operator00:25:38That's a little more specific forward-looking than I want to get into. We have customers with current assays that we're supporting. Oftentimes that comes into the onboard kits where we're supporting the validation at new sites and training of operators at new sites. That's for an existing assay if we're not already in the cartridge or in the kit. That's, I think, where we're winning good business and business prospects there. For assays that are now being developed, that's where we have the opportunity to go either be included in the boxes of test cartridges as an external control, the swab, for example, or be included in the cartridge itself as some of the critical biological materials in the cartridge. Both of those are moving forward. Operator00:26:44The onboard kits opportunities, typically those are 6-figure opportunities, but over time they move into 7 figures across multiple assays with clients. Some of the other opportunities range from 6-figure to 7-figure to even some 8-figure opportunities that we're looking at now. Those don't go from 0 to 100 all at once, you know, this is where there may be disclosures whereby we're talking about a large project, but that may involve development revenues in the first year, validation lots and pre-launch stocking in year 2, and full and growing commercial sales from year 3 forward. These are, you know, these are big projects, and big projects don't happen, you know, don't go from 0 to 100 overnight. Speaker 100:27:50Seen any cancellations on the CapEx side in terms of? Operator00:27:55No. Speaker 100:27:57Um, and then Operator00:28:00That's a, I like that answer. That's a quick answer. No. Speaker 100:28:05It's a good answer. Operator00:28:06Yeah. Speaker 100:28:06Previously, QAPs revenues were about CAD 1.6 million a quarter. This quarter, CAD 0.6 million. Will this be normalized level moving forward or do you expect things to normalize back up to around CAD 1.6 million, and what's the time on that? Speaker 200:28:22Yeah, no, that's, if you don't know whether you call it seasonality or not, but we've got one of our largest customers on the proficiency testing side, has three events a year, and it just happens in our Q1, Q3, and Q4, but nothing in Q2. Those events are anywhere from CAD 1 million-CAD 1.3 million, that's the reason why there was that dip in the second quarter. Operator00:28:51Yeah. Speaker 200:28:51It'll definitely bounce back up into Q3 and Q4. Operator00:28:54Absolutely. Yes. The way some of these proficiency or testing or external quality assessment schemes work is that the clinical labs will receive a box of blinded samples in a disease area, 3 times a year and not 4 times a year. We're shipping to our client, the agency running those schemes, 3 times in the calendar year. As Jim indicated, that happens to land in revenues for us in Q1, Q3, and Q4. Now, you know, as we gain additional clients in that category that may have different timing of shipments and we increase our sales to the major test manufacturers in the QAPs category. We increase our sales at the B2C level with the clinical labs. Operator00:29:58Those don't have that sort of periodicity associated with the 3 shipments per year. It's more regular. That starts to smooth. Speaker 100:30:09Got it. Where you're supporting QAPs customers with onboard kits and validation at new sites, are these assays approved or still in development? If approved, does this represent recurring revenue? Operator00:30:25Those would be for approved assays by definition because they're rolling out at clinical sites that need that training, validate, you know, new onboarding or validation. There are two categories in the onboard kits. For new sites, that is, one-time business. For the regular retraining that needs to happen and for training new technicians due to the turnover that inevitably happens in any industry, staff turnover, those are recurring revenues. There's both. Speaker 100:31:06Okay. I've got one last audience question here. Just going back to Kinlytic. I understood that revenues from Kinlytic would start in 2027, and now hearing 2028. What's caused the delay? Operator00:31:22I don't think there's a delay per se on this. We've spoken to a filing in the second half of 2027, followed by an FDA review, then, you know, the product launch should happen in 2028. Exactly where in 2027 and where in 2028 is where there's some flex in timelines. You know, part of that too is, you know, what is the exact timing of the BLA filing, and how fast does the FDA review it? Ken, I don't know if you wanna add to that. Speaker 300:31:58Yeah. Yeah, yeah. It may well be the case that there's revenues in 2027, but at the end, at the end of the day, I'll preface my comments by reminding the group that we do have an approved regulatory file with the FDA, and we have no chance of clinical failure with a product that has been successfully used in the clinic for decades. Notwithstanding that, it's a non-trivial activity to set up new manufacturing, both for the drug substance and the finished drug product, and all the analytics that go with that. All of those different areas are being done at contract manufacturing organizations with our partner, Sequel. It's all moving forward as it should. Then, you know, there's a level of complexity that we have to manage. Speaker 300:32:42The timeline hasn't changed. Of course, when we make the regulatory file, we have the vagaries of the FDA. Maybe they'll be expeditious, maybe they won't. Notwithstanding it, we're targeting for that approval time to be at the back end of 2027. Obviously we can't build even though we've had discussions with user groups in the dialysis clinics and things like that, the regulatory agencies in Europe all have a big pull for this particular product. They want this product. Till we have it, we can't start marketing it. The building of the market will start in 2028. The work will happen in 2027 as previously described. There may be little vagaries associated with the CDMOs and the complexity of the product and the FDA. Speaker 300:33:25Right now there's nothing on the horizon. We're just moving forward as we said we would. Operator00:33:29Yeah. In my, you know, in my view from what I've seen, this is a market that is neither fully satisfied at present, in terms of the quantities of product needed, nor is it satisfied in terms of the service that it's receiving by the incumbent. I'm optimistic we're going to see some pretty big switching happening quickly. Speaker 300:33:58Yeah. Operator00:33:58You know, it's not a question of grinding out, you know, small client by small client. It's a question of moving big users over to our product quickly to give them, you know, better product, security of supply, some price relief. There's a lot of reasons why customers for Kinlytic would consider quickly adopting this product in their, in their clinical settings. Whether that's, you know, hospital, hospitals, chemotherapy, parenteral nutrition, dialysis, there's a lot of use cases for Kinlytic that are very compelling, in my view. Speaker 300:34:43Yeah. There's a huge pull for this product. There's only one incumbent in the marketplace, and they have supply issues, so we'll be securing supply with frankly a superior product. Speaker 100:34:56Are you seeing any indication that, Sequel's pursuing any of approvals beyond the first indication? Operator00:35:04Not as yet. We're all very cognizant of it. The current production methodologies are extremely well suited for satisfying the catheter clearance indication, which is less hungry for active ingredient. It uses, you know, one-fiftieth or less of the amount of drug active for a catheter clearance treatment than it would for a pulmonary embolism, for example. You know, one of the things that certainly we're going to continue to pursue aggressively with our partner is Microbix taking a role in redeveloping the upstream to be more efficient, the upstream API or drug substance manufacture to be more efficient. That's just the exact kind of work we've proven our ability to deliver upon with our antigen products, and Rubella specifically. Operator00:36:03You know, we've gone through a very steep learning curve successfully on that, and really I think have unrivaled expertise in how to do that. That, that's something that will come, but you can't demonstrate comparability until you have in-dated product. Once we have acceptable drug product for and drug substance and drug product for the catheter clearance indication, then we have something to benchmark against on redeveloping the upstream for pulmonary embolism and the many other systemic applications for which Kinlytic has been successfully used. Ken, am I misspeaking? Speaker 300:36:45Yeah, I mean, Sequel has stated and many times that they have interest in all indications in all jurisdictions. Do we, and we get a share of that action, of course. But the place to start is the catheter management indications, where the amount of active is much smaller and is readily made in CDMOs, so we can satisfy a half billion dollar market in North America, then the equivalent in Europe, before we actually start looking at these bigger indications, which are bigger markets, but require 50-100-fold more active. I think that's really the I think Sequel quite correctly is saying, "Let's get that foot in the door, we'll build from there." Now, the technologies are related. Speaker 300:37:27It's just scalable. I think the group knows that Microbix is excellent at scaling. We are set up ready to do that, and we'll bring that online at the appropriate time. You never know, maybe we'll be doing some manufacturing in Canada. You never know. Operator00:37:42It sure would be nice. Speaker 300:37:43It would be nice. Speaker 100:37:46A follow-up question to the assay question I asked maybe 10 minutes ago. Why one-time business? Once a client assay is launched, are QAPs controls not needed on a repeat regular basis? Operator00:38:01QAPs controls, QAPs are needed on a regular repeat basis. It depends on the context we're looking at. In a clinical setting, ongoing quality management and external quality assessment is part of the laboratory ISO 15189 standard. There is recurring business associated with that. Use of a kit to validate a site, you know, at the start of use, you've sold new equipment to that site. You're going to use an onboard kit to train the staff the first time to use the equipment. You're gonna use onboard kits on regular intervals to retrain, you know, refresh training, train new staff. You're also going to use controls at regular intervals as part of your quality management system to challenge the tests and make sure there aren't any systemic errors. Operator00:39:00QAPs are also going to be used, provided by the PT/EQA scheme providers, the third-party accreditation groups, as a part of their sort of audit challenges of the labs to truly make sure they know what they're doing. There's at least four instances where QAPs are used on an external basis, and then there are instances where QAPs materials may be used either as in-cartridge reagents or may be used as part of the manufacturing process. For example, our QUANTDx products that are quantitated materials may be used as part of the manufacturing QC release criteria for a test manufacturer, and that's an area we're building as well, where we're selling the QUANTDx products to people that are either developing a test or manufacturing a test. Operator00:40:03That's a valuable touchpoint with customers as well, and we're already generating material sales and building up, making sure we have validated manufacturing for a growing range of catalog numbers in the QUANTDx line. Jim kind of furrows his brow a little bit seeing our growth in inventory as we grow the number of seeds and cell bank materials and raw materials that we need to provide the range of capabilities our customers need. If somebody wants a 15-plex, you know, control for materials, we've got to have every biological target in that material, and we've got to have that banked and validated internally to be able to manufacture that, transfer it to manufacturing. Operator00:40:58you know, whether it's our product management and business development group, whether it's our R&D group, whether it's manufacturing, QC, QA, you know, finance, you name it, everybody's hopping to deliver on these pending and WIP projects. Speaker 100:41:21If they're validated on your QAPs, will it be your QAPs they use as regular controls? Operator00:41:28Sorry, could you repeat that question? Speaker 100:41:30Sorry, I was just going back to the, I think it's a follow-up to the same question. If they're validated on your QAPs, will it be your QAPs that they use as regular controls? Operator00:41:41Yes. Speaker 100:41:41I'm assuming it's Yes. Okay. Operator00:41:43Yeah. Speaker 100:41:44I think that's all I have for questions, gentlemen. Any final thoughts? Anything we didn't cover today that you wanted to discuss? Operator00:41:52Well, you know, I think I would circle back to the concept of capabilities, capacity, and credibility. You know, we built all three of these, and we're now, you know, engaged with leading companies in our industry for, you know, large business opportunities because we've done that. You know, we're not, we're not arm-waving, you know, stock promoters here. We're very much running and building an operating business and delivering on those opportunities, and that applies to, you know, what we've done in hardening and strengthening systems, improving yields on, you know, antigen products and capability to deliver there, creating the whole range of QAPs and QUANTDx products, and driving forward with a very real drug development opportunity with Kinlytic. Operator00:42:48This is all reality stuff, and, you know, we're committed to building real sustained value within the business, and I think we're building that. You know, notwithstanding the vagaries of, you know, quarter by quarter and different, you know, individual customers and markets, the big picture shouldn't be lost of the value that we're creating within this business. Speaker 100:43:13Got it. Okay. Operator00:43:14Yeah. Speaker 100:43:14Well, thank you very much for your time. Sorry, Ken, did you have something? Speaker 300:43:17Yeah, I was gonna just- Operator00:43:18Yeah Speaker 300:43:18just supplement that a little bit. I mean, we're getting audits. We're getting bigger and bigger clients, present clients, future clients, and potential future clients coming in for audits and seeing what we do at Microbix, and I know a number of the group have already toured Microbix. We never have a problem. We always pass audits with flying colors because we're very serious about what we do from an operational perspective. Cameron also talked about the infantry side, 'cause we, you know, we're making a lot of seeds, a lot of products. You make a lot of products, you need a lot of seeds, and we're very good at doing that and managing that going forward. People who come in to see what we do are impressed by that. Speaker 300:43:53We have a broad portfolio of scientific and technical capabilities that are scalable and are directly applicable to what we do, and I think everybody's starting to recognize that, and hopefully we'll reap the benefit of that going forward, plus Kinlytic on the side. Operator00:44:10Yeah. I think I'll just clarify two things. One, we're talking about quality system audits, customers wanting to know that if they're incorporating our products within theirs, or as a companion to theirs, that we can deliver on every aspect of quality, consistency, reliability. I think barely a month goes by now that we don't have such a visit. The activity level's very high. I'm just gonna, Ken said inventory, not infantry, just in the case anybody was confused there. Speaker 300:44:49Strange accent this guy's got. I don't know. Operator00:44:52Lots of good things happening, and, you know, we'll continue to communicate that. Just as we have with regards to some of the scientific congresses that we discuss, whether it's EUROGIN, whether it's ESCMID, Passive, these congresses at which Microbix data is presented, sometimes by Microbix and sometimes by Microbix customers or prospective customers, these are not lost on the industry. I know that can be a little bit, a little bit technical, but I do urge people to read between the lines a little bit about this. You know, to whom is that targeted? It's sure, it's part of our continuous disclosure, and it's great for everybody as investors, but that's also not lost on customers. Operator00:45:46You know, we recently presented at ESCMID some data on some very innovative work around RNA test controls. You know, presenting in the last hours of the last day of a conference and, you know, we had 35 people lined up to discuss our poster. This is very impactful within the industry. Our news releases aren't just intended for investors, but they're also very widely read by industry and impactful for industry, so multiple constituencies. You see some of the touch points as well. The podcast series, for example, gives us visibility with policymakers, and it gives us great touch points with leading experts in the field and makes it that much easier to win new business when somebody says, "Well, who's Microbix? Operator00:46:38Maybe I hadn't heard of them." They go on, and they see the technical excellence that we're delivering the companies and thought leaders we're rubbing shoulders with. This, again, is that driving real value creation for our business and value creation that I'm dead certain we're gonna see realized. Speaker 100:47:01Great. Well, you've made good progress. Sounds like you got a lot of irons in the fire. I don't see any additional questions. We're coming up on the hour. I think we can leave it there. If anyone does have any follow-up questions or would like a meeting, please feel free to reach out. Thank you to the audience for your participation and your questions, and thank you Jim, Ken, and Cameron for making yourselves available. Operator00:47:25Thank you so much, Deborah. Speaker 300:47:27Thank you. Operator00:47:27It's always a pleasure, you know, we couldn't do this without the ongoing support of our many shareholders. Thank each and every one of you for your support of our work. We really do appreciate it. Speaker 100:47:43Thanks, everyone. Speaker 300:47:44Thanks, Deborah. Operator00:47:44Okay. Thanks, everyone. Speaker 100:47:45Take care. Speaker 300:47:46Bye-bye.Read morePowered by Earnings DocumentsPress Release Microbix Biosystems Earnings HeadlinesMicrobix Biosystems Inc.: Microbix Schedules Release of Results for Q2 Fiscal 2026May 8, 2026 | finanznachrichten.deMicrobix Schedules Release of Results for Q2 Fiscal 2026May 8, 2026 | finance.yahoo.comYou'll buy SpaceX at $1.75 trillion. Insiders bought at $20 billion.Insiders bought SpaceX at $20 billion. Banks got in at $100 billion. By the time it hits your brokerage account, the price tag is $1.75 trillion - making retail investors the exit liquidity. There's a different play. One small, already-public company powers the infrastructure SpaceX literally cannot run without. Dylan Jovine has identified the ticker.May 14 at 1:00 AM | Behind the Markets (Ad)Microbix Biosystems Inc.: Microbix Product Results Being Presented at 2026 PASCVApril 27, 2026 | finanznachrichten.deMicrobix Product Results Being Presented at 2026 PASCVApril 27, 2026 | finance.yahoo.comMicrobix Presenting at the 2026 Bloom Burton ConferenceApril 16, 2026 | theglobeandmail.comSee More Microbix Biosystems Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Microbix Biosystems? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Microbix Biosystems and other key companies, straight to your email. Email Address About Microbix BiosystemsMicrobix develops proprietary biological technology solutions for human health and well-being, with about 90 skilled employees and sales growing from a base of over $1 million per month. It makes a wide range of critical biological materials for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products that support clinical lab proficiency testing, assay development and validation, or clinical lab workflows.View Microbix Biosystems ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles YETI Rallies After Earnings Beat and Raised OutlookCisco’s Vertical Rally May Still Be in the Early InningsHow the 3 Leading Quantum Firms Stack Up After Q1 EarningsNebius Upside Expands as AI Feedback Loop IntensifiesOklo Stock Could Be Ready for Another Massive RunAmazon vs. Alibaba: One Is Clearly The Better Value Play right NowD-Wave Earnings Looked Weak, But Investors May Be Missing This Upcoming Earnings Mizuho Financial Group (5/15/2026)Palo Alto Networks (5/19/2026)Home Depot (5/19/2026)Keysight Technologies (5/19/2026)Analog Devices (5/20/2026)Intuit (5/20/2026)NVIDIA (5/20/2026)Lowe's Companies (5/20/2026)Medtronic (5/20/2026)Target (5/20/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 4 speakers on the call. Speaker 100:00:00Call. I have Cameron Groome, CEO, Ken Hughes, COO, Jim Currie, CFO. I'm not sure if we're gonna work off a presentation today, but as always, this session will contain forward-looking statements. If you'd like to know more about those, you can find them on the presentation on the company's website. There will be a Q&A section, so feel free to enter any questions you have in the Q&A box. With that out of the way, I'd like to turn the mic over to Cameron. Hi, Cameron. Operator00:00:28Good morning, Deborah. Thank you so much. Good morning, Ken and Jim Currie. I just want to thank everybody on the call for joining us for this update call this morning. As everybody will have seen from our results in Q2, it's not a particularly pretty quarter. The revenues were well below our engineered breakeven point, which is about CAD 5.5 million a quarter of revenues. Not unexpected to show a net loss, we are continuing to control our costs well. You know, net losses are not what we get dressed up in the morning for, you know, even if controlled. Operator00:01:12Some of that, and I'll ask Jim to speak to any specifics and address particular questions, but we have continued, of course, to see lower year-over-year sales into China, and that's a principal driver for the year-over-year comparability. We also saw some, as we normally see in Q2, is not a strong quarter for our sales to the proficiency testing and external quality assessment agencies, so our QAPs products. We did see some antigen sales that we'd aimed to land in Q2 delayed until later in the year that weren't made up by QAPs programs just due to some continued client delays. It's a bit frustrating, and it doesn't reflect the level of effort and fine work that we're doing, exerting on now looking to secure new business. Operator00:02:15You know, if I reflect on where we'd hoped to be at this point, we're probably, we're certainly well behind that level. You know, it took decades to get this business to CAD 10 million in revenues. We've been adding to our capabilities considerably, we're actually looking to bring back about CAD 10 million in revenues within 12 months of a couple of major client fall-offs. It's a steep hill we're climbing, and I think we're climbing it very well. We started with building capabilities for our business and broadening those out, modernizing the antigen production, bringing in the skills and capabilities to create our quality test control products, our Quality Assessment Products or QAPs. We worked successfully on building the capacity to produce those at scale. Operator00:03:18I think because of that, now we've really achieved the credibility as a result of both the capabilities and capacity we have successfully built. What we need to demonstrate, I think, now to investors is the league that we're actually playing in. I'm very confident that over the coming months, we are going to be able to demonstrate that. There are opportunities that we're pursuing that are at a scale that's unprecedented for our business that we can absolutely deliver on, and our prospective customers know that we have both the skills and the capacity to execute on that. These are opportunities that really dwarf anything we've seen so far coming into our company. We're very optimistic that we'll win that business now. Operator00:04:12As we look forward, we have to abide by our disclosure policies, which are, you know, we will only discuss specifics of opportunities when they are either secured by way of a firm contract agreement or begin to realize material revenues. We're really at the cusp of some of those developments, I believe, and that's definitely forward-looking information, so you know, you can't take that to the bank yet. These are the things we're working on and why we get up in the morning. We'll also talk about the ongoing work on our Kinlytic file as well, which is advancing well towards a supplemental biologicals licensing application filing. That is moving ahead as a value creator. Operator00:05:04We continue to have our business on the diagnostic side playing at the highest levels of industry now and working with many multiple large companies and driving value on that front, while we continue to, on a fully funded basis, advance a clinically and economically important therapeutics program. That's, you know, very much where we are. We are quite optimistic about what we're achieving, and we continue to have a strong balance sheet to be able to execute on that, notwithstanding the quarterly losses we've seen over the past few quarters. With that, maybe I can pass over to Jim to speak to any high points you'd like to call out about a quarter that's far from a high point. Operator00:05:57Ken, we'll then pass over to you for operations, and then Deb, we can move into any questions from those on the line. Speaker 200:06:07Great. Thanks, Cameron. Yeah, it was, as Cameron's indicated, it was a disappointing quarter. I mean, it's tough comparator to last year. I mean, we've been looking at our numbers, and last year, last year's first half was actually excluding Kinlytic license fees, last year the first half was the record half. It's been a tough comparator this year against that. A lot of that record was created by the distribution into China. That reduction in revenues of about CAD 2 million a quarter has had a significant impact on the business. Without that, we actually, in the second quarter, we actually grew the rest of our business, excluding our Chinese distribution, 13% during the quarter. There was some upside in terms of our performance to the quarter. Speaker 200:07:01Margins aren't where we want or targeting. Our target has always been in the 60-ish % range, which we achieved last year in the quarter. This year, lower volumes. We've got fixed manufacturing costs that we're absorbing within our lower volumes, that's leading to, you know, lower margins at this point in time, higher cost of sales. From a balance sheet perspective, still strong. Cash, CAD 8.1 million. Our cash burn during the quarter was about CAD 1 million, that's sort of where we see it over the next few quarters as well. Operator00:07:48Yeah. Jim, I'll just mention that you know, if we look at the traditional cash flow from operations or operating cash flow is about CAD 300,000. When we're talking about burn, we're also including capital investments, activities, and financial activities, including debt repayment and, you know, a prudent ongoing level of share buybacks. Speaker 200:08:12Yeah. On the cash front, I mean, while we have benefited from interest-free loans from FedDev over the last number of years to support the growth of our business, we're now in a position where we've started, during this quarter, to repay that debt. That's something new in terms of our cash spend that will occur over the next 5 years, as we've got 5 years to repay that no interest loan. CapEx, as Cameron said, we're not only our OpEx, but on our CapEx, we're trying to control spending, we're making investments in capital equipment where we need to. The nice to haves, we're delaying at this point in time. We're monitoring the spend. Speaker 200:09:11We're continuing to spend on our NCIB. We bought about 1.5 million shares at a cost of CAD 361,000. I think we believe that continuing that spend is important for the business and to help maintain our stock price level during a weaker time. Operator00:09:40Yeah. During an interval where, we're rebuilding, we certainly don't want to see a situation where anybody starts to get abusive in share price. I think I'll be looking at potentially at some further purchases personally, and that expresses, you know, our confidence in the business, not only individually, but collectively through the NCIB. Speaker 200:10:06Great. Kind of summarizing where we are right now, I mean, as Cameron Groome and I have both indicated, controlled spending. We're making sure we're investing our funds and spending our money in the right places. We have started to see some orders coming in from China. That's a good sign. We had budgeted to see that. I think we had budgeted to see that happening a little sooner. It is starting to happen now. Good outlook there. We're maintaining our capabilities. We wanna make sure that we keep the staff that we have today. We've got a strong employee base, and we've got growth expectations that are gonna require people with these skill sets as we move forward. We've indicated we've got the strong balance sheet, we've got the cash. Speaker 200:10:58We've had the cash to get us through and this hurdle at this point in time and to invest as we move forward. Ken, you got anything? Speaker 300:11:09Sure. I got plenty. The group knows we've been building operations for a while here. Cameron alluded to the fact that we're building both capacity and capability. In terms of capabilities, not, we started from a position of classical virology and pathology. We've added synthetic virology and pathology, and recombinant now capabilities here as well, which is a pretty unique portfolio of capabilities from a capability perspective. From a capacity perspective, we've been building semi-automated and automated procedures, scalability left, right, and center, really to give us the capacity and capabilities to support the growth going forward. That has not changed. Everything has been implemented and is operating extremely well. Speaker 300:11:59From an operational side, we continue to use operational excellence to increase yields in specific products to reduce costs and ultimately drive margins, and that's what we've been doing. We've been doing successfully. We're adding to our portfolio of QAPs. We're continuing to improve our antigens capabilities and going on from there. Our electronic quality management system is getting more and more sophisticated and more and more integrated, which is improving efficiencies and dovetailing nicely with our enterprise resource planning software. All the things we've said we're gonna do from an operational perspective are being executed where we have unique capabilities, I would say, and some global leadership in a number of areas, including QAPs and antigens and certain specific ones from within there, from within those portfolios. Speaker 300:12:48We have plenty of capacity to scale as these new opportunities come online. We're ready to go. I can't speak highly enough about the staff we have here, the scientific, procedural manufacturing, quality control, quality assurance. Even the finance people are quite good. We're doing really well from an operational perspective. I should have mentioned IT as well. We're really doing very well. I have nothing negative to say at all. We're ready to accept the opportunities as they come to us. That's great from an operational perspective. Perhaps a comment on Kinlytic as well. Kinlytic is moving forward as it should. Our relationship with Sequel continues to be strong. Scale-up and validation of drug substance manufacturing is underway. Speaker 300:13:32We're working with the drug product CDMO now as well. The timelines have not changed. We're moving forward. We expect material events over the next little while and submissions in 2027, building that market in 2028 as being disclosed. The relationship remains excellent. The scientific component is moving ahead. I think that's something that's very exciting for the future. Once we come back for the catheter clearance market, there are other markets to get involved with too. We're talking to our partner Sequel about those indications as well and whether or not we could bring some manufacturing component to Canada. That's again a forward-looking statement right now. Speaker 300:14:13We're working towards getting the supplement to the BLA filed and then start building the market for catheter management in the U.S., and then subsequently in the rest of the world, and that project is on schedule and on course. Operator00:14:27Yeah. Very good. No, thank you. Thank you, Ken. I'll just reemphasize, you know, this is, you know, major customers really need to see the capabilities and the both the capabilities and the capacity. If they're going to rely on Microbix as a critical sole source supply chain partner, we have to demonstrate all this. We have regular stream of major companies now coming in and doing multi-day quality systems audits of our capabilities and our capacity to ensure that they can trust us on these matters. We pass those with flying colors, and now have access to a scale of opportunity that would have been unthinkable a few years ago. Operator00:15:23That's not to give assurance we'll win that business, but it gives us assurance, you know, we are, certainly in our view, the best partner for such companies, and I think that's a view that they're coming to share more and more. You know, I'm increasingly optimistic that we'll be able to, at the, when the time is ripe, make some very interesting, very interesting business disclosures. Justified optimism. It's not naive optimism, but it's justified. And those of you who visited us see both the human resource capabilities as well as the technology and the infrastructure we have, to be able to deliver on these opportunities. And certainly, there's no slowdown in the technical advancements in the global diagnostics industry, whether that's on molecular diagnostics, multiplex tests, point of care. Operator00:16:22You know, all this is happening and being driven and we're really very much at the heart of it. You know, you'll see my reference to our logo in the corporate presentation where we're really at that intercept point between our customers and their target markets, and that's never been more true than it is today. Thank you. You know, not a financial quarter that we're going to be putting into the record books by any means, but I think this is turning out to be a really fun year. I'm very optimistic for the second half of this year from a fundamental developments and value creation point of view. Operator00:17:08I think that's probably a great place to leave it, Deborah, and maybe we can move over to questions. I see a few in the queue, and if you'd like to read those out, we'll do our level best to answer them. Speaker 100:17:23I had some via email, so I'll start with those ones. Operator00:17:28Very good. Speaker 100:17:29This antigen decrease was a result of a CAD 2 million reduction in sales to the company's distributor for China, believed due to reduced incidents of respiratory diseases requiring testing and tighter test access and reimbursement policies. I thought your sales to China for an entire year were CAD 2 million. Do they all historically come in Q2? Operator00:17:53No. Our, our sales in China in 2025 fiscal, were closer to, Sorry, 2024 fiscal, I should say. Thank you. I could see Jim's brow starting to furrow as he began to correct me. For fiscal 2024, we did about CAD 7 million into China in fiscal 2024, and we were on track to do north of that, and we're at CAD 8 million plus run rate through the first half of 2025, and that really fell off quite abruptly. I think we're you know, certainly speaking to our partner in, or that distributes into China for us, they're not exiting the market and they don't see it as gone. Operator00:18:37There was just a very abrupt slowdown in the incidents of walking pneumonia or white lung, as they called it in China, coupled with restrictions on people going to multiple hospitals or clinics and being tested multiple times. It's just, you know, as greater trust perhaps is being developed in that market, people were wanting to make sure the test they got was actually working and accurate, and doing tests, retesting. We've got a bit of a double whammy there, along with the normal cost control pressures that we see all around the world. That slowed things down, but we see as end users there, work through their inventories, we see reorders happening, and we're already starting to see that. It's not been at that high level. Operator00:19:35We were budgeting a little over CAD 1 million into China this year. I think we're below that level so far in terms of the run rate. I know we're below that level in terms of the run rate so far. We'll see when that comes back, and it could snap back as early as the fall, or that could push out a little bit more. Where the new normal becomes in China is the question. You know, do we look for CAD 1 million, CAD 2 million, CAD 4 million? You know, these are the questions we're trying to benchmark with our partners now. Is there another outbreak and it snaps back to a much higher level than that? Either way, we're ready for it. Operator00:20:17We can deliver on the volumes as may be required, but we're not counting on that as the big growth driver. Our big growth driver remains QAPs in the near term, nearer term, and Kinlytic going out at that 2028 timeframe that Kenneth indicated. Speaker 100:20:36So- Operator00:20:36Jim, did you wanna speak further on that, on that question? Deborah, do you feel we've answered it? Speaker 100:20:42Yeah, I had a follow-up, but Jim, if you have extra color, feel free. Speaker 200:20:46Oh, no, I didn't have any. I think, Cameron, you covered it correctly. I mean, I think we were seeing CAD 2 million a quarter for a period of, I guess, 6 quarters. That was not historically the level that we had seen in terms of revenues from China. There's no question. I mean, they really came up quite substantially in fiscal 2024. Prior to that, sales were probably in the, you know, CAD 2 million-CAD 4 million annualized with our Chinese distributors. We did see an uptick in 2024 and 2025, the first half of 2025. Operator00:21:21Yeah. That was not evident to either us or our partners or the manufacturers in China that that was going to be a temporary issue. It looked like there was an ongoing need for that testing, and nobody saw that slowing down as abruptly as it did. Speaker 100:21:41Is there seasonality in that typically? Operator00:21:44There is some seasonality in respiratory infections generally. It tends to be winter months. That's a tendency. It's not a hard line, you know. Sometimes you'll see, for example, COVID has now more of a fall incidence as there's a bit more of a back to school driver necessarily than a winter one. You know, we see some of the gastrointestinal infections occurring more in the spring and summertime. You know, food spoilage and camping and so forth. There's all these interlocking waves. As we continue to grow our business, we're seeing different sources of that volatility, and that, you know, we see that also evening out as we add additional large clients. Speaker 100:22:36The issue of titer test access and reimbursement, what has the bigger impact, that or reduced respiratory diseases? Operator00:22:49Tough to know exactly. I believe for us it is the incidence of respiratory disease more. We've also seen, we're also told there's been a consolidation of the number of test manufacturers has been reduced in China with a number of the more marginal players falling away. Speaker 100:23:11A follow-up question to that. Given the tight access and reimbursement policies, does that mean that even if respiratory diseases rebound, sales to China will be substantially lower than in years before the drawdown? Operator00:23:28Tough, tough to know. You know, the products we're selling into China are quite unique. You know, we are the global leader in the manufacture of those antigen products. You know, there's always a question, you know, is there a domestic manufacturer? I don't think there's anybody that has either the purity, the capacity, or the economics that we have. We're not, you know, we don't have marble fountains in the courtyard and gold-plated washrooms. You know, we do run a frugal cost base in our organization even though our science is excellent, as is our quality. I don't think there's a real ability to undercut it, or to deliver the same quality of product. Operator00:24:20People in medical devices manufacturing, you know, by definition should be conscious of quality as well. Speaker 100:24:28What, when will you know if your Chinese distribution partner will want to resume buying antigens for this year's? Operator00:24:35They already have, but at a lower level. Speaker 100:24:39Okay. Operator00:24:42you know, it's a question of inventory at three levels. There's inventory at the end user level, there's inventory at the distributor level, and there's inventory at the Microbix level. you know, we, as we see the latter two, the end user and the distributor inventories deplete, that's when our inventory gets pulled out. Speaker 100:25:02You've seen orders in both Q2 and Q3? Operator00:25:06Jim, when have we booked those orders? I'm just losing track here. Speaker 200:25:14In Q3. Operator00:25:14the current ones are Q3. Speaker 200:25:16Q3. Operator00:25:16Yeah. Yeah. Thank you. Speaker 100:25:19Moving on to caps. Have any of your large caps clients recently commercially launched their assays? Speaker 100:25:29soon to launch their assays? What's the expected revenue impact for Microbix at these launches this year and beyond? Operator00:25:38That's a little more specific forward-looking than I want to get into. We have customers with current assays that we're supporting. Oftentimes that comes into the onboard kits where we're supporting the validation at new sites and training of operators at new sites. That's for an existing assay if we're not already in the cartridge or in the kit. That's, I think, where we're winning good business and business prospects there. For assays that are now being developed, that's where we have the opportunity to go either be included in the boxes of test cartridges as an external control, the swab, for example, or be included in the cartridge itself as some of the critical biological materials in the cartridge. Both of those are moving forward. Operator00:26:44The onboard kits opportunities, typically those are 6-figure opportunities, but over time they move into 7 figures across multiple assays with clients. Some of the other opportunities range from 6-figure to 7-figure to even some 8-figure opportunities that we're looking at now. Those don't go from 0 to 100 all at once, you know, this is where there may be disclosures whereby we're talking about a large project, but that may involve development revenues in the first year, validation lots and pre-launch stocking in year 2, and full and growing commercial sales from year 3 forward. These are, you know, these are big projects, and big projects don't happen, you know, don't go from 0 to 100 overnight. Speaker 100:27:50Seen any cancellations on the CapEx side in terms of? Operator00:27:55No. Speaker 100:27:57Um, and then Operator00:28:00That's a, I like that answer. That's a quick answer. No. Speaker 100:28:05It's a good answer. Operator00:28:06Yeah. Speaker 100:28:06Previously, QAPs revenues were about CAD 1.6 million a quarter. This quarter, CAD 0.6 million. Will this be normalized level moving forward or do you expect things to normalize back up to around CAD 1.6 million, and what's the time on that? Speaker 200:28:22Yeah, no, that's, if you don't know whether you call it seasonality or not, but we've got one of our largest customers on the proficiency testing side, has three events a year, and it just happens in our Q1, Q3, and Q4, but nothing in Q2. Those events are anywhere from CAD 1 million-CAD 1.3 million, that's the reason why there was that dip in the second quarter. Operator00:28:51Yeah. Speaker 200:28:51It'll definitely bounce back up into Q3 and Q4. Operator00:28:54Absolutely. Yes. The way some of these proficiency or testing or external quality assessment schemes work is that the clinical labs will receive a box of blinded samples in a disease area, 3 times a year and not 4 times a year. We're shipping to our client, the agency running those schemes, 3 times in the calendar year. As Jim indicated, that happens to land in revenues for us in Q1, Q3, and Q4. Now, you know, as we gain additional clients in that category that may have different timing of shipments and we increase our sales to the major test manufacturers in the QAPs category. We increase our sales at the B2C level with the clinical labs. Operator00:29:58Those don't have that sort of periodicity associated with the 3 shipments per year. It's more regular. That starts to smooth. Speaker 100:30:09Got it. Where you're supporting QAPs customers with onboard kits and validation at new sites, are these assays approved or still in development? If approved, does this represent recurring revenue? Operator00:30:25Those would be for approved assays by definition because they're rolling out at clinical sites that need that training, validate, you know, new onboarding or validation. There are two categories in the onboard kits. For new sites, that is, one-time business. For the regular retraining that needs to happen and for training new technicians due to the turnover that inevitably happens in any industry, staff turnover, those are recurring revenues. There's both. Speaker 100:31:06Okay. I've got one last audience question here. Just going back to Kinlytic. I understood that revenues from Kinlytic would start in 2027, and now hearing 2028. What's caused the delay? Operator00:31:22I don't think there's a delay per se on this. We've spoken to a filing in the second half of 2027, followed by an FDA review, then, you know, the product launch should happen in 2028. Exactly where in 2027 and where in 2028 is where there's some flex in timelines. You know, part of that too is, you know, what is the exact timing of the BLA filing, and how fast does the FDA review it? Ken, I don't know if you wanna add to that. Speaker 300:31:58Yeah. Yeah, yeah. It may well be the case that there's revenues in 2027, but at the end, at the end of the day, I'll preface my comments by reminding the group that we do have an approved regulatory file with the FDA, and we have no chance of clinical failure with a product that has been successfully used in the clinic for decades. Notwithstanding that, it's a non-trivial activity to set up new manufacturing, both for the drug substance and the finished drug product, and all the analytics that go with that. All of those different areas are being done at contract manufacturing organizations with our partner, Sequel. It's all moving forward as it should. Then, you know, there's a level of complexity that we have to manage. Speaker 300:32:42The timeline hasn't changed. Of course, when we make the regulatory file, we have the vagaries of the FDA. Maybe they'll be expeditious, maybe they won't. Notwithstanding it, we're targeting for that approval time to be at the back end of 2027. Obviously we can't build even though we've had discussions with user groups in the dialysis clinics and things like that, the regulatory agencies in Europe all have a big pull for this particular product. They want this product. Till we have it, we can't start marketing it. The building of the market will start in 2028. The work will happen in 2027 as previously described. There may be little vagaries associated with the CDMOs and the complexity of the product and the FDA. Speaker 300:33:25Right now there's nothing on the horizon. We're just moving forward as we said we would. Operator00:33:29Yeah. In my, you know, in my view from what I've seen, this is a market that is neither fully satisfied at present, in terms of the quantities of product needed, nor is it satisfied in terms of the service that it's receiving by the incumbent. I'm optimistic we're going to see some pretty big switching happening quickly. Speaker 300:33:58Yeah. Operator00:33:58You know, it's not a question of grinding out, you know, small client by small client. It's a question of moving big users over to our product quickly to give them, you know, better product, security of supply, some price relief. There's a lot of reasons why customers for Kinlytic would consider quickly adopting this product in their, in their clinical settings. Whether that's, you know, hospital, hospitals, chemotherapy, parenteral nutrition, dialysis, there's a lot of use cases for Kinlytic that are very compelling, in my view. Speaker 300:34:43Yeah. There's a huge pull for this product. There's only one incumbent in the marketplace, and they have supply issues, so we'll be securing supply with frankly a superior product. Speaker 100:34:56Are you seeing any indication that, Sequel's pursuing any of approvals beyond the first indication? Operator00:35:04Not as yet. We're all very cognizant of it. The current production methodologies are extremely well suited for satisfying the catheter clearance indication, which is less hungry for active ingredient. It uses, you know, one-fiftieth or less of the amount of drug active for a catheter clearance treatment than it would for a pulmonary embolism, for example. You know, one of the things that certainly we're going to continue to pursue aggressively with our partner is Microbix taking a role in redeveloping the upstream to be more efficient, the upstream API or drug substance manufacture to be more efficient. That's just the exact kind of work we've proven our ability to deliver upon with our antigen products, and Rubella specifically. Operator00:36:03You know, we've gone through a very steep learning curve successfully on that, and really I think have unrivaled expertise in how to do that. That, that's something that will come, but you can't demonstrate comparability until you have in-dated product. Once we have acceptable drug product for and drug substance and drug product for the catheter clearance indication, then we have something to benchmark against on redeveloping the upstream for pulmonary embolism and the many other systemic applications for which Kinlytic has been successfully used. Ken, am I misspeaking? Speaker 300:36:45Yeah, I mean, Sequel has stated and many times that they have interest in all indications in all jurisdictions. Do we, and we get a share of that action, of course. But the place to start is the catheter management indications, where the amount of active is much smaller and is readily made in CDMOs, so we can satisfy a half billion dollar market in North America, then the equivalent in Europe, before we actually start looking at these bigger indications, which are bigger markets, but require 50-100-fold more active. I think that's really the I think Sequel quite correctly is saying, "Let's get that foot in the door, we'll build from there." Now, the technologies are related. Speaker 300:37:27It's just scalable. I think the group knows that Microbix is excellent at scaling. We are set up ready to do that, and we'll bring that online at the appropriate time. You never know, maybe we'll be doing some manufacturing in Canada. You never know. Operator00:37:42It sure would be nice. Speaker 300:37:43It would be nice. Speaker 100:37:46A follow-up question to the assay question I asked maybe 10 minutes ago. Why one-time business? Once a client assay is launched, are QAPs controls not needed on a repeat regular basis? Operator00:38:01QAPs controls, QAPs are needed on a regular repeat basis. It depends on the context we're looking at. In a clinical setting, ongoing quality management and external quality assessment is part of the laboratory ISO 15189 standard. There is recurring business associated with that. Use of a kit to validate a site, you know, at the start of use, you've sold new equipment to that site. You're going to use an onboard kit to train the staff the first time to use the equipment. You're gonna use onboard kits on regular intervals to retrain, you know, refresh training, train new staff. You're also going to use controls at regular intervals as part of your quality management system to challenge the tests and make sure there aren't any systemic errors. Operator00:39:00QAPs are also going to be used, provided by the PT/EQA scheme providers, the third-party accreditation groups, as a part of their sort of audit challenges of the labs to truly make sure they know what they're doing. There's at least four instances where QAPs are used on an external basis, and then there are instances where QAPs materials may be used either as in-cartridge reagents or may be used as part of the manufacturing process. For example, our QUANTDx products that are quantitated materials may be used as part of the manufacturing QC release criteria for a test manufacturer, and that's an area we're building as well, where we're selling the QUANTDx products to people that are either developing a test or manufacturing a test. Operator00:40:03That's a valuable touchpoint with customers as well, and we're already generating material sales and building up, making sure we have validated manufacturing for a growing range of catalog numbers in the QUANTDx line. Jim kind of furrows his brow a little bit seeing our growth in inventory as we grow the number of seeds and cell bank materials and raw materials that we need to provide the range of capabilities our customers need. If somebody wants a 15-plex, you know, control for materials, we've got to have every biological target in that material, and we've got to have that banked and validated internally to be able to manufacture that, transfer it to manufacturing. Operator00:40:58you know, whether it's our product management and business development group, whether it's our R&D group, whether it's manufacturing, QC, QA, you know, finance, you name it, everybody's hopping to deliver on these pending and WIP projects. Speaker 100:41:21If they're validated on your QAPs, will it be your QAPs they use as regular controls? Operator00:41:28Sorry, could you repeat that question? Speaker 100:41:30Sorry, I was just going back to the, I think it's a follow-up to the same question. If they're validated on your QAPs, will it be your QAPs that they use as regular controls? Operator00:41:41Yes. Speaker 100:41:41I'm assuming it's Yes. Okay. Operator00:41:43Yeah. Speaker 100:41:44I think that's all I have for questions, gentlemen. Any final thoughts? Anything we didn't cover today that you wanted to discuss? Operator00:41:52Well, you know, I think I would circle back to the concept of capabilities, capacity, and credibility. You know, we built all three of these, and we're now, you know, engaged with leading companies in our industry for, you know, large business opportunities because we've done that. You know, we're not, we're not arm-waving, you know, stock promoters here. We're very much running and building an operating business and delivering on those opportunities, and that applies to, you know, what we've done in hardening and strengthening systems, improving yields on, you know, antigen products and capability to deliver there, creating the whole range of QAPs and QUANTDx products, and driving forward with a very real drug development opportunity with Kinlytic. Operator00:42:48This is all reality stuff, and, you know, we're committed to building real sustained value within the business, and I think we're building that. You know, notwithstanding the vagaries of, you know, quarter by quarter and different, you know, individual customers and markets, the big picture shouldn't be lost of the value that we're creating within this business. Speaker 100:43:13Got it. Okay. Operator00:43:14Yeah. Speaker 100:43:14Well, thank you very much for your time. Sorry, Ken, did you have something? Speaker 300:43:17Yeah, I was gonna just- Operator00:43:18Yeah Speaker 300:43:18just supplement that a little bit. I mean, we're getting audits. We're getting bigger and bigger clients, present clients, future clients, and potential future clients coming in for audits and seeing what we do at Microbix, and I know a number of the group have already toured Microbix. We never have a problem. We always pass audits with flying colors because we're very serious about what we do from an operational perspective. Cameron also talked about the infantry side, 'cause we, you know, we're making a lot of seeds, a lot of products. You make a lot of products, you need a lot of seeds, and we're very good at doing that and managing that going forward. People who come in to see what we do are impressed by that. Speaker 300:43:53We have a broad portfolio of scientific and technical capabilities that are scalable and are directly applicable to what we do, and I think everybody's starting to recognize that, and hopefully we'll reap the benefit of that going forward, plus Kinlytic on the side. Operator00:44:10Yeah. I think I'll just clarify two things. One, we're talking about quality system audits, customers wanting to know that if they're incorporating our products within theirs, or as a companion to theirs, that we can deliver on every aspect of quality, consistency, reliability. I think barely a month goes by now that we don't have such a visit. The activity level's very high. I'm just gonna, Ken said inventory, not infantry, just in the case anybody was confused there. Speaker 300:44:49Strange accent this guy's got. I don't know. Operator00:44:52Lots of good things happening, and, you know, we'll continue to communicate that. Just as we have with regards to some of the scientific congresses that we discuss, whether it's EUROGIN, whether it's ESCMID, Passive, these congresses at which Microbix data is presented, sometimes by Microbix and sometimes by Microbix customers or prospective customers, these are not lost on the industry. I know that can be a little bit, a little bit technical, but I do urge people to read between the lines a little bit about this. You know, to whom is that targeted? It's sure, it's part of our continuous disclosure, and it's great for everybody as investors, but that's also not lost on customers. Operator00:45:46You know, we recently presented at ESCMID some data on some very innovative work around RNA test controls. You know, presenting in the last hours of the last day of a conference and, you know, we had 35 people lined up to discuss our poster. This is very impactful within the industry. Our news releases aren't just intended for investors, but they're also very widely read by industry and impactful for industry, so multiple constituencies. You see some of the touch points as well. The podcast series, for example, gives us visibility with policymakers, and it gives us great touch points with leading experts in the field and makes it that much easier to win new business when somebody says, "Well, who's Microbix? Operator00:46:38Maybe I hadn't heard of them." They go on, and they see the technical excellence that we're delivering the companies and thought leaders we're rubbing shoulders with. This, again, is that driving real value creation for our business and value creation that I'm dead certain we're gonna see realized. Speaker 100:47:01Great. Well, you've made good progress. Sounds like you got a lot of irons in the fire. I don't see any additional questions. We're coming up on the hour. I think we can leave it there. If anyone does have any follow-up questions or would like a meeting, please feel free to reach out. Thank you to the audience for your participation and your questions, and thank you Jim, Ken, and Cameron for making yourselves available. Operator00:47:25Thank you so much, Deborah. Speaker 300:47:27Thank you. Operator00:47:27It's always a pleasure, you know, we couldn't do this without the ongoing support of our many shareholders. Thank each and every one of you for your support of our work. We really do appreciate it. Speaker 100:47:43Thanks, everyone. Speaker 300:47:44Thanks, Deborah. Operator00:47:44Okay. Thanks, everyone. Speaker 100:47:45Take care. Speaker 300:47:46Bye-bye.Read morePowered by