Microbix Biosystems Inc.

Microbix Biosystems Inc.

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Microbix Biosystems Inc. (MBXBF) Q4 2024 Earnings Call Transcript

Published at 2024-12-19 11:00:00
Deborah Honig
[Call Starts Abruptly]. This session will deal specifically with those earnings or that earnings release rather. With me today, I have Cameron Groome, President and CEO; Ken Hughes, COO; and Jim Currie, CFO. As always, this presentation 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, which will be updated today. And there will be a Q&A session, so feel free to enter your questions in the Q&A box, or you can send them directly to me. With that out of the way, thanks, gentlemen, for joining me this morning.
Cameron Groome
Morning, Deborah.
Jim Currie
Pleasure, Deborah.
Deborah Honig
Thank you. Yes. Congrats on the great quarter.
Cameron Groome
It caps a very successful year, I believe, for us. And we'll talk about the year, the quarter and the year to come or the year we're already in, actually. But before we get into discussion of the financial results for Q4 and fiscal 2024, I thought I might touch on some of the strategic achievements and focus areas that, we've had for 2024 and going into 2025. Our primary focus has been and very much remains on achieving thought leadership in our areas of the diagnostics industry in ensuring maximum test accuracy both with our provision of antigens, as ingredients and our caps test quality assessment products or test controls as they're called. We've acquired significant new customers and we're focused continue to be focused on acquiring new customers in North America, the EU and Asia and expanding our business with existing customers is a big focus area for us. And with that, we are very much committed to holding our compound annual growth rate of revenues in the 20% to 40% per year band. And in 2024, we achieved the upper range of that band with 40% growth in our ongoing sales for the company. And that compares to our industry, which is usually in the 5% to 10% is considered very good performance. So, when we're performing at 4 times to 8 times the growth rate of our industry, we're pretty pleased with that. And while we're doing that, we're also demonstrating some very strong control of our operations by maintaining positive EBITDA, positive net earnings, positive cash flow, and actively repurchasing shares. So not only are we growing the business, we're growing it while managing our resources appropriately and not diluting shareholders. In fact, move the company to an anti-dilutive overall position. So, we very much believe that our actions to advance the revenue driven business as well as our Kinlytic Therapeutics project, which we'll, I'm sure, touch on as well, are building very much real and sustained value within Microbix for our shareholders. And the financial results that Jim will move to summarize are really the reflection of that fundamental and strategic work we're doing to create value. So, Jim, why don't I hand off to you, and you can give a summary of Q4 and the fiscal year 2024.
Jim Currie
Thanks, Cameron. It's a real pleasure, actually, this year to present the results. It's excellent from, quarterly as well as the fiscal year. It's not always been that way, so it's great. Yes. Q4 was an excellent quarter. Record revenues, $6.3 million revenues, up 48% from last year's, Q4. We saw a good growth in both businesses. Antigens were up 50%, while our caps business was up 42%. Again, that came with some strong margins as well. Margins were 55%, well above where we were last year, and that all led to, an 18% EBITDA for the quarter, and it was a great finish to, a great year. On an annualized basis, we ended at $25.4 million in revenues, 40% growth. We saw a gain, saw a growth on both businesses. Engine's up 44%, caps up 38%. We also had the recognition of $3 million worth of U.S. Kinlytic milestone, payments in Q1 of the year, so that contributed to the fiscal year performance as well. Ken will go into a little bit more about where we are with, the Kinlytic businesses in his discussion. Again, core business margin growth was great, and it went from 40% last year to 53% for the year, and it was just excellent performance.
Cameron Groome
Jim, I'll just make a quick note. You're normalizing, of course, in your 40% sales growth and your 53% margins for the year to take out the one-time revenue the immediate revenues from Kinlytics. So, if we were to include Kinlytics, the revenue growth would be 54% for the full year and the margin be 60.6%. But Jim is already doing a bit of the analyst work and carving that back.
Jim Currie
Sorry. Yes.
Cameron Groome
No worries.
Jim Currie
Thank you for, clarifying that for us, for me and for them, listeners as well. Appreciate that. We also had a close to $2 million investment in our facilities, our equipment, and acquisition of some core technology during the year as well. So, again, utilizing some of our the cash that we have to helps help support the growth of the business. As Cameron outlined, we purchased greater than, 2% of our shares during the year, 2.6 million shares, again, to help stabilize, our share price over the year. And so, overall, an excellent performance for 2024. I may not look excited, but I don't get as excited as the other two guys, but I am. And so, it was a great year, and we've got off to, as Cameron will probably outline, we've gotten off to a good start to the year. We're pretty close to finishing our first quarter for the year, and it's looking strong as well. Ken, would you like to give us some update on the operations?
Ken Hughes
No. Jim gets excited in his own way. He just shows it differentially. From a scientific and operational perspective, you know, this has been a great fiscal 2024, and there's no two ways about it. I've spoken, we've spoken a lot about capacity building over the years and we continue. We've built a lot of capacity and we continue to build that capacity. We now have three facilities over 34,000 square feet. We opened the last another lab 2,000 square feet CL-2 containment QC and R&D, the Berkeley to build our capacity and our portfolio of product lines going forward, which is opened by Minister Tanguy this year. I should point out that we've used capital that was not too expensive by using support from FedDev Ontario at the federal level and from the provincial government from the Ontario Together Fund granting system and we've deployed that money. And we have a reputation for seeing what we're going to do and then doing it. Our new automated filling line is now fully operational in Building 3, which commissioned in the last couple of years. We've implemented our electronic quality management system in our enterprise resource planning software successfully to build capacity and build efficiency going forward, and we're adding in augmenting capabilities, integration of those capacities, as we speak. Our quality system has been audited, we recertified ISO 9001, ISO 1345. We've done the infectious in vivo diagnostic regulation a very high lift for the European authorities, so we can continue selling CE Mark medical devices into Europe. We've had a client audits of several of those, all of which have gone extremely well and speaks to the operational excellence we have at Microbix. We continue to do process development through our manufacturing, our development and our engineering teams to build and improve yields, to improve margins going forward and we're deploying our unique capabilities in infectious disease diagnostics and other aspects of biomedical science to diversify offerings going forward. And that's in the core business side, everything is going extremely well, which brings me to Kinlytic, and Kinlytic is also going extremely well. I've said many times, we have an excellent relationship with CECO Pharma, just funding this particular program. We have a fabulous CDMO who's doing great work in upgrading the systems to contemporary standards. I was in a great meeting with them this morning. And all I can say is the stated timeline for 2027 is unchanged. If anything, it's derisked moving forward at a pace and everything is going extremely well. I have no bad news to deliver. Operationally, Microbix is in very good shape and we're just continuing to build.
Cameron Groome
Brilliant. Thank you, Kevin. That's great. I know we want to take most of the time today to address shareholder questions, but I'll just make a few concluding remarks, before we move over to that segment. One of the things we of course doing is, making sure that our little business is growing. And our little business is growing and our little business isn't so little anymore. I was reflecting on our Q4 top-line of $6.3 million and that effectively means, we are making sales of about CAD100,000 every single business day. Clearly, there are customers buying what we are selling. And what we are selling is providing some real value to them. So, we're growing the business very, very well in that respect and becoming a larger company, as Ken has outlined with our systems and Jim has highlighted with our financial results. We are also working to expand the total addressable markets that we can tap into. While infectious disease diagnostics is a tremendous market of tens of billions of dollars. It's not the pinnacle of our ambitions to stay in that silo. So, we are adding capabilities and addressable markets. And through the year, you've seen us describing some of our work, most recently moving into the area of genetics testing and supporting a program, one of the first programs I'm aware of, for urgent point of care genetic testing. And we're right in there supporting it. We're also supporting work in oncology and in fact molecular pathology in looking at supporting the accuracy of pathology, histopathology, and molecular analysis of tissues that may have tumors that have been driven by infections with viruses. So, a great crossover between our expertise in infectious disease and the new mark addressable markets in oncology and the emerging field of molecular pathology as well. So again, this speaks to the kind of the thought leadership that we're driving and getting upfront, creating new markets, creating markets alongside our customers, and building some real and sustained value for our shareholders. And you see similar skill and diligence with our Kinlytic urokinase project, which will really supercharge an already strong value creation engine as we move ever closer to re approval of that drug by U.S. FDA. So again, very strong year in fiscal 2024. We're looking for an even stronger year in fiscal 2025 that we've already begun. And as Jim has highlighted, we're off to a great start for fiscal 2025 as we close in on Christmas and the conclusion of our first quarter of the fiscal year. So, with that, I wish I had any negatives to report, but everybody is doing superlative work here. I just can't thank our team enough. And we also are very grateful for the support of our many shareholders as well. So, Deborah, with that, maybe we can open it to questions about the picture for the company and the results just posted. A - Deborah Honig: Sure. Sounds good. First question is for you, Jim. What's the outlook for gross margins in each segment and for the total company for 2025, if you're able to give us any guidance?
Jim Currie
We don't typically provide guidance on forward outlook. I think what I can say is that we are kin continually working on our pricing as well as the cost structure of the organization to improve our margins. And we've always indicated that our margin target for the organization is somewhere in the 60% range. So, I would suggest that's continues to be our target, but I can't really speak to specifics at this point in time.
Cameron Groome
Yeah. I think, certainly, we'll be looking at, we're certainly targeting higher gross margins in all product lines. And we pursue operational efficiencies as well as intelligent pricing that works for both us and our customers. So, I wouldn't look for 2025 gross margin to be down. I would look for it to be up. And the question is how close to that penultimate target do we get in each quarter. And there's always going to be a bit of fluctuation quarter to quarter depending on mix between antigens and caps and product mix within those categories as well. So, there'll be a bit of quarter-to-quarter fluctuation in margins. But you've seen through our fiscal 2024, some fluctuation in margins quarter-by-quarter as well. And it's only been a swing of a few points if you normalize for Kinlytic milestones.
Jim Currie
I would also comment we've got that critical mass now to address these issues in terms of operational efficiency. I can't speak highly enough of our development, quality control and engineering teams and the manufacturing as well, who are addressing all opportunities to maximize yields, minimize costs, reduce batch failures, because we're in a biological world, things go wrong, but they're going wrong less and less and less and we get more and more and more success. So, we're going to be building margins just through operational excellence as well and that's and we have the critical mass to do that now by design.
Deborah Honig
Switching gears to revenue. So, a comment from the audience, congrats on such strong revenue growth. Going forward, do you expect the growth rate in the antigen and CAHPS businesses to taper off at all? Do you have a target growth rate range?
Cameron Groome
First question, do we expect growth to taper off? No, we don't. We expect growth in both categories. Our antigens business is realizing much of the potential we've hoped for it and intended and directed it to. We're seeing some very strong sales growth into Asian markets, which we have looked at as being the growth market, primary growth markets for the antigen business, but we're also seeing some solid growth in North America and Europe as well. So very strong there. Caps continues to grow very strongly as well, and these two business lines really paced each other incredibly well through fiscal 2024 with both of them up well into the upper end of our target growth range. I think that, compound annual revenue growth rate that we're targeting for the business is in that 20% to 40% growth per year that we're aiming for. Certainly, we'll control our financial projections and our cash management to the lower end of that range, but we'll certainly be targeting to get to the upper end of that range or beat it if we can. It's up to investors and analysts to really decide, where they believe we'll land. We don't provide a pinpoint guidance outside of that broad range.
Deborah Honig
Talking specifically about the growth in antigens, I was under the impression that, antigens is sort of a GDP growth rate business, at least in Europe and the Americas or North America. What's driving that additional growth? Are you capturing orders from customers? Can you maybe elaborate a little bit on that growth?
Cameron Groome
Absolutely. We certainly are not missing growth opportunities within our native antigens business in North America and Europe. But that does tend to pace population growth, as well as a bit of, not so much GDP, but population growth. Where we are seeing some very nice opportunities emerging is in markets where these tests have not been done historically or not been done in the frequency. But as, countries become wealthier, people want better health care, they certainly deserve it, and they want it, and they can get it finally. And we're right in the midst of that transition. And those are markets if you go by population that are potentially much larger than the European and North American population. So, it really gives us some very strong growth opportunities in the antigen business. And we have been investing, as Ken has noted in the operational excellence of our antigen business and its efficiencies and capacity. And certainly, we'll be targeting as well to add to the breadth of technology that we're able to bring to bear on that business and maximize its growth opportunities going forward. So, expect to hear more from us on that.
Deborah Honig
I had some more specific questions about antigen growth. Sorry, these are coming from multiple sources. So, I'm trying to aggregate them.
Cameron Groome
Hey, better, better. You do the aggregating. We'll do the answer.
Deborah Honig
So, still talking about antigen growth. Do you think this was driven by a catch up in orders following weaker pandemic years? Or do you think this level is the new baseline?
Cameron Groome
I think this level is the new baseline, and will from which we will be building.
Deborah Honig
And were there any onetime shipments that boosted the quarter but will hurt next quarter? This is specifically antigen as well. Okay. And I don't see anything else on antigen. Here we go. What is the growth rate in antigen's in established markets, U.S. and Europe? Is all the growth in emergent that question was already answered? Okay. Let's just move on to, let's talk about operating leverage. Is it reasonable to expect operating leverage given the revenue growth forecast? Or should we just see more investment in infrastructure and SG&A to offset it?
Cameron Groome
If by operating leverage, we mean, it's meant driving a higher proportion of profit. I think that's where we're striking a balance between where we feel the best intercept for value creation is. We could certainly minimize reinvest the business and investment systems capacity and excellence and drive a whole lot more profit to the bottom line. Where we're balancing is between maximizing revenue growth, customer capture, new opportunities, new addressable market areas and demonstrating control of the business. So that's I think the balance we'll be looking to strike in 2025 in driving that. And that's where we feel the maximum value creation for the businesses. It'd be very, very healthy EBITDA, strong earnings and cash flow. And we'll be even more aggressive, I think, going forward on our share repurchases and cancellations. But it's not 100% slam as much to the bottom line. We're not polishing the business up for a quick sale. We're building it on the fundamental value.
Deborah Honig
Can you provide an update on the CapEx outlook? Which investments are now concluded and which costs from 2024 are going to will drop out going forward? And can we anticipate any new ones coming into the calculation?
Cameron Groome
Well, I'll give a bit of a summary on that, and then I'm going to defer to Jim as to how specific we want to get. We'll certainly be making CapEx investments at a strong rate in 2025. From my memory, we're certainly above $2 million in capital investments planned for the year. In terms of categorizations, Jim, how would you want to break them into categories?
Jim Currie
I guess, in terms of categories, I mean, the investment in 2025 will probably be less so on what I would call facilities or labs or et cetera. We will have some investment in labs, but a lot of it's on equipment. Additional equipment, replacement of equipment, we've always got aging equipment that requires replacement, and we want to have our products and our inventory secure. And so, that's where the investment seems to be going for next year. And as Cameron, you indicated, yeah, our initial capital plan is in the $2 million range. But as always, our staff knows that they it's not signed and approved. They've always got to go through and do the proper justification for the investments that they're making.
Cameron Groome
Yes. A lot of it is actually capacity building as well. I'm just looking at our schedule, Jim, from the Board package. So, a lot of things that we're -- some of the equipping of additional lab upgrades to lab spaces, additional capacity driven equipment and capability driven equipment as well. So, it's a very healthy mix, but all supported within our cash management plans.
Jim Currie
Yes. I mean, we're continuing to build capacity to build this business to a much bigger business and we need that capacity to do that. We're moving away from the kind of bricks-and-mortar capacity to the skills capacity and the execution capacity. That's the way for business to grow. Obviously, we're not going to over invest, but we're going to make sure we're ready to accept the opportunities we've been building towards and reap the benefits of the thought leadership position in the various areas we're in going forward.
Deborah Honig
I have a couple of CAPS questions. Sorry to jump around a little bit.
Cameron Groome
No, no worries.
Deborah Honig
I should have gone. And just CAPS that general, but I think I tripped myself up with so many questions. So, for CAPS, are you able to share approximately how much of the CAPS revenue in 2024 was generated from QuidelOrtho?
Cameron Groome
QuidelOrtho is an important customer for us, and we are doing a reasonable level of revenues from them, but they are not our biggest CAPS customer. They are a meaningful one, but they are not the only one, nor are they the largest. So, a lot of our work with Cornell is continuing to support the development of assays on the Savanna. The comments in Cornell's Q3 presentation and their recent investor presentation that was December 3 to 5, described their outlook for Savanna in that they are continuing to prepare for the respiratory virus panels with the view that for late 2025 approval and to drive additional panels, they already have a respiratory panel approved in Europe, a general ulcers panel approved for North America, and they're looking at the newer respiratory virus panel, 4plex and a STI panel as the next assays. They are targeting approval on that platform, the platform itself already being approved, of course. And our work backs up from that. So obviously, there has to be inventory ready to support any launch of a new assay. And so, you can count back three to six months from any time lines of theirs for them to have inventory in hand to support product launches. And then, of course, that has to be built, designed and built prior to that. So, our revenues actually track back even further in the build of product, build of inventory, and then approval and launch. So, we do see them being a significant customer in 2025, but again, not our largest caps customer nor our only one.
Deborah Honig
How much visibility do you have for caps growth this upcoming year? How much revenue could be at risk due to customer delays?
Cameron Groome
Not a huge amount of our revenues, CAPS revenues for 2024 for the full year, as you've seen in the news release disclosure this morning was on the order of CAD7 million. We're looking for that to grow double digits certainly well within our guidance span for fiscal 2025. And we have a growing list of customers, any one of which having a breakout will drive revenue growth in caps and also margin expansion. A lot of our work in the external quality assessment and proficiency testing industry with caps are very complex products but small runs comparatively speaking. And those serve to depress the margins of that segment. So as some of these break out from proficiency testing schemes into full commercial launches with major international companies, those manufacturing run sizes expand dramatically. And that should lead to margin expansion in that category as well.
Deborah Honig
Okay. And then for 2025, the 20% to 40% revenue growth rate target, is that based on 2024 revenues, including Kinlytic or excluding that milestone?
Cameron Groome
We would be looking at the baseline revenues from 2024 and growing off of that baseline. So, our growth, if one removes the Kinlytic milestones, we were $15.1 million in fiscal 2023 in terms of ongoing sales revenue and $21.3 million in fiscal 2024. And we'd be building off that base of sustained revenues. Now, Kinlytic will kick in, we believe, quite dramatically towards the end of calendar 2027 with both approval and sales driven milestones as well as royalties on sales. And that will have a dramatic impact at that point for our business. And we'll be growing like hell in the interim.
Deborah Honig
I assume the same for gross margins. When you say they're going to increase year over year, that's excluding the milestone. Correct?
Cameron Groome
Correct. Yes.
Deborah Honig
Okay.
Cameron Groome
Gosh. I'd make such a terrible politician. I'm answering yes and no to questions rather than going through some horrible redirect.
Deborah Honig
I like it. I mean, short and sweet. Get to the point. Okay. Going back to CAPS, has QuidelOrtho reached the performance that they feel they need in the new panels, so low development risk? Are they still working towards getting the performance they want, so some development risk?
Cameron Groome
Certainly, I'm not going to speak to their development risk. We're supporting them extremely well. And they have capable teams developing these assay panels. There are of course clinical validations and regulatory filings that need to be made. So, you're looking at multivariate equations. So, I'm not guaranteeing their performance other than saying, it's a great company and we're very pleased to be working with them.
Deborah Honig
Kinlytic, with Kinlytic proceeding so well, is there any chance of expanding the geography and indication of the current partner agreement prior to the formal FDA approval of the SBLA?
Cameron Groome
I'm going to go with another political answer on that one and say, yes. Yes, we are certainly looking at with our partner and certainly encouraging them to consider moving forward aggressively on both clinical label expansion, things like catheter prophylaxis, and the resuming systemic programs. But that's their funding decision at the end of the day. We're going to provide the best technical support we can, and certainly encourage them as we strongly believe in the clinical utility and clinical importance of the product as well as the economic -- very attractive economic drivers on that. Ken, what would you want to add to that?
Ken Hughes
Yes. There's absolutely no desire to stop after catheter clearance in the North American market. There's catheter clearance in Europe, there's catheter prophylaxis everywhere, and then there's the bigger indication, which are bigger markets for indications related to pulmonary embolism, like peripheral artery, locressive disease, stroke, even cancer indications associated with this product, and there's every intention to pursue all of these opportunities going forward.
Cameron Groome
Yes. So, we see Kinlytic very much as just an opportunity that continues to broaden and broaden both from clinical indications and geography. And I believe, we've said previously, we have had the European Medicines Agency reach out to Microbix and say, please don't forget about us. When you have a package to provide, we want to engage with you and see if this could be brought into Europe. Now, kinlytic was never approved in Europe, so it's not precisely the same pathway, as it would be in the United States and Canada, where it had been previously approved. But there's really been a tremendous openness on the part of the European regulators to engaging with us to see how it can be expeditiously brought into the European market, because there's a screaming need there as well.
Deborah Honig
There's a question I can answer. Are you interested in buying blocks with the NCIB? Yes. Call me or call the company if you have one for sale. Anything to add there, Cameron?
Cameron Groome
Absolutely. We did engage a block in -- we were made aware of a block in October. We said we're willing to buy the entire block under the NCIB. And, then Deborah advised us that might upset a few current shareholders so then we have demand from current shareholders for more than the entire block. So, we had to saw it off in the middle and the NCIB ended up buying back 1.1 million shares of that 3.3 million share block. But we will absolutely react to any blocks and continue to view our shares as undervalued based on the fundamentals of our business. I see companies in our area that have no sales, no cash or losing lots of money and are pure concept that have a higher market cap in some instances than our growing healthy operating profitable business that has well north of 100 customers, multiple products, generating revenues cash flow. We have -- we ended the fiscal year with close to $13 million in cash on the books and shareholders' equity growing shareholders' equity of $28 million even while we're buying back shares, which reduces shareholders' equity. So, we're in a great position and we will absolutely be aggressive in buying back stock.
Deborah Honig
Can you please expand on the opportunities you're seeing for controls in the oncology and genetic testing areas that you recently entered? Any thoughts on breaking out cab sales into these three segments of the future as they mature in addition to infectious disease controls?
Cameron Groome
Well, we've got to be a little bit careful just how much we break things out because as a public company, we've got to keep shareholders informed, but that also telegraphs our moves to potential competitors. Now we've had some sit downs with different competitors and some of them have just said, you're so far ahead of us, we're not going to catch up. Could you would you consider working with us? So that's high praise indeed. But we have to be careful what we telegraph. So just remind everybody, our disclosure practice is when something is done, we announce it. We don't announce our intentions, our ambitions, our hopes, dreams and aspirations. We announce when a project is completed to a measurable milestone. Some of the ones we've announced recently, one of them extraordinary, our first genetic test control. And this is for a genetic test that identifies patient's far greater susceptibility almost to the point of certainty that treatment with a certain class of antibiotics will result in profound irreversible deafness in that patient. And there's some cases, particularly in pediatrics, where an urgent antibiotic intervention is needed. And thus far, that's really been, -- my gosh, I'm so sorry you went deaf. We should have perhaps we should have chosen a different antibiotic that might have been would be -- but that would be less effective. This is a point-of-care genetic test that, in an emergency context determines is a patient at risk of that side effect, yes or no. Bang. Then you can treat with the certainty, that you've got the right risk-benefit for that antibiotic class. So that's the innovative work we're doing. Our work in formalin fixed paraffin-embedded tissue sample pneumetics for oncology. There's a big mouthful of words. Effectively looking at, when a pathologist is looking at a tissue slice and doing both conventional pathology analysis and molecular diagnostic testing on that, there are effectively no standardized controls for that, which leaves a lot of subjectivity and room for error in diagnosis of cancer and particularly in virus-driven cancers like HSV and HPV. We're starting to provide those controls. An area that is arguably out of control is being brought into greater test accuracy directly by work Microbix is doing. So, we're working with thought leaders around the world on that, and that'll form a whole new class of test controls. And we're right in the thick of that as well. There's many, many of these opportunities that we see, and all of those as they mature, drive real revenues to microbix. So, some years down the line, yes, perhaps we'll start breaking those out. Right now, I think it would be both telegraphing our moves a little bit more than we'd wants. And those revenues are just starting now. They'll be breaking into six figures in 2025 in these different categories and probably break into seven figures in 2026 and maybe eight figures 2027 and beyond, but great opportunities for us. And just again, as more and more customers are working with us, it becomes easier to acquire the next one. And it's the best thing to do is build the base -- the breadth and size of product revenues with each existing customer as well.
Deborah Honig
Moving on to tariffs. So, specifically, how much revenue was from the U.S. market in fiscal 2024? How much is anticipated in 2025 and beyond? And what could a 25% U.S. tariff mean for Microbix's business and future growth prospects?
Cameron Groome
Great question. The tariff issues, if we take them at face value, it should be an incredibly easy thing to address. There's hundreds of billions of dollars of cross border-trade just between and I think it's $600 billion or something just for Ontario with the U.S. never mind Canada as a whole. The incoming administration in the U.S. says they have concerns about illegal immigration and drug smuggling, let just strengthen the damn border. Why is this even a conversation? So, but if there isn't that leadership at the Canadian federal level to do it or at the Canadian provincial level to do it, then those tariffs may come on. Even if for a short time that's going to hurt both U.S. and Canadian consumers. For us, as a supplier of critical materials, these are so sticky and so regulated there is little alternative for our U.S. customers. But to pay those tariffs certainly in the immediate term. And we certainly hope that there'll be adults in the room to make sure that if they do come on in January, that'll be a short-term thing. In terms of the proportion of our U.S. sales, some of our U.S. sales are currently rooted through the U.S. into Asia. Obviously, we would change that routing and bring those into Asia directly. So, that would immunize us fully against any impact on that segment of our business. And for U.S. Centered customers, they would have little choice but to continue with us for over that short term and absorb that disruption. So, our products are both critical, complex and sticky. And this gives us a very good advantage as there's no easy substitution to be made. Jim, anything you'd want to supplement on that or Ken?
Ken Hughes
We have UV capabilities that a lot of people don't have. We are a global leader in the antigen area and the caps area. So, to comment to point out, products are very, very sticky. The regulatory hurdles to change is not worth the effort. So, in the short term, as you say, you have to the European sorry, the American customers will have to deal with that we hope. Again, that Sensible Minds will prevail quickly and will go back to the appropriate trade, but we do have opportunities to distributors to move distribution out of the U.S. and into Europe or Asia and that that will support us. But the bottom line is we're a global leader here and our products are very, very sticky. So, I doubt this will have much of an effect on us at all.
Cameron Groome
Yeah. It's a great point, Ken. And just looking at where we are in the overall value chain of testing. Our products are a few percentage points of the overall value of a test. So even if a tariff is were to be applied on our products. If you're looking at adding 25% to a nickel, that's not life changing for the customer either. So, gives us a good position there.
Deborah Honig
VTM, any update on VTM or what used to be the VTM lines?
Cameron Groome
VTM, we are building the VTM -- rebuilding the VTM. Principally, we've been using it is elution buffers or reagent sales are transforming into elution buffers for our controls business, particularly in our onboard kits. The government procurement continues to be -- what was the Churchill thing, a mystery wrapped in an enigma surrounded by a riddle or something like that. So, the government procurement, no private industry sales, yes.
Deborah Honig
Hey. And two more I would say, more corporate general questions. One, I have been a shareholder for many years and, over that period of time, have seen very little change in the board of directors. I think it's about time new blood be brought into the business. What plans do the company have to make these changes?
Cameron Groome
Interesting commentary. I think we've demonstrated with over the past several years with the tripling of sales and with going from consistent losses to profitability that we have a very good board. We have a board that holds certainly management to account, management that holds ourselves to account. And we have moved as well to specific performance driven goals and milestones that the senior managers are measured against. And our performance really reflects that. With regards to board renewal, our most recent addition of Director was Jennifer Stewart, who brought some very strong skills in the government relations field, where we're positioning ourselves to really have a strong voice on policy development at the federal level and working with others at the provincial side as well. So that's been strong. And I think you'll see Board renewal as we go forward. Certainly, some of our directors will ultimately want to retire and will see Board renewal through the Human Resources Governance & Compensation Subcommittee of the Board as we go forward. But we're not on some DEI train or renewing just for the sake of renewing. We are very much looking at what skills our Board has and how it functions.
Deborah Honig
No obvious areas that you're lacking in terms of skill sets?
Cameron Groome
Not that we see. Joe Renner brings tremendous experience in the pharmaceutical side. Mark Cochran, public policy and healthcare, Peter Blecher in clinical medicine; Jen Stewart, government relations; Juan Gabriel Panaloni on Audit Committee and Financial Matters. We've got a very good breadth of Board skills on that.
Deborah Honig
If you're successful in your move into genetics and oncology, is that an area that you would look to potentially add?
Cameron Groome
Question whether -- sorry, and I didn't mention our Chairman, Martin Moreno, of course, adds tremendous skill across the pharmaceutical and legal side as well. Sorry. Just on the oncology side, some of these areas, absolutely, we are developing strong relationships with thought leaders in that field in clinical medicine as well as the technical sides. Question whether those are Board positions or not is an open word. Do we start to formalize the Scientific Advisory Board where we have tremendous, but informal relationships now, or do we add somebody on the Board side? And adding on the Board, perhaps if we were to add it might be somebody with specific diagnostics industry, acumen as well, more on the commercial operational side there and just look over our shoulders a little bit. But I think we're performing much better in the past five to seven years, in spite of all the volatility that was introduced by the pandemic, which certainly upended many plans. And we successfully adapted into the pandemic, during the pandemic and out of the pandemic. And I think if you look at many players in our industry, we're less successful on all three fronts.
Deborah Honig
Another comment from the audience, Cameron, just suggesting that you could use a capital markets person on the Board and maybe you could give a little bit of your background too, because I think you fill that role.
Cameron Groome
Sure. I've been in the life science industry for more than three decades now and half of that was spent on the sell side of the financial business as both an equity research analyst where I spent a decade and as an investment banker, where I spent half a dozen years leading the practice of a major Canadian dealer in the space. So, I do have some good capital markets experience and expertise. And we also involve others, including Deborah Hoenig in Adelaide Capital, who Deborah's background for those of you that may not know was institutional equity sales before she started Adelaide Capital. So, we do look to maintain that visibility.
Deborah Honig
Cameron says a series of four life decisions that led me to Investor Relations.
Cameron Groome
I did actually say that.
Deborah Honig
One last question for you, Cameron. Is M&A still on the table? Is this something you're still considering?
Cameron Groome
Yes. M&A cuts two ways. For ourselves, we've looked at some businesses that we concluded they were additive rather than firmly synergistic. So, with our share price, we didn't feel particularly enthusiastic about diluting shareholders for an acquisition opportunity that merely added size and adjacent revenue lines. We will consider and continue to consider things that are strongly synergistic and accretive for our business. And one of the things we'll be looking to is to make sure we're properly prepared for such opportunities if and when they emerge. So that's something we're looking at. And now with our ERP system fully -- ERP upgrade fully operational and our EQMS, digital quality management system work advancing more quickly to completion now, it becomes more sensible to consider our ability to successfully integrate an acquisition. It's not just about doing a deal, it's what happens at the day after the deal closes that's the big element of concern. The other side of the M&A coin is okay, gosh, we are still in a market where fast-growing healthy small-cap companies such as ourselves are not necessarily getting their value fully appreciated in the marketplace. And that's certainly not lost on our competitors and private equity firms that have expressed, hey, guys, would you sell or gosh, we're hoping you'll stumble and we'll be able to buy you without a change of control premium. There are still folks expressing that level of interest. And our response remains consistent that we're not entrenched managers. But if somebody seriously wants to do something in transacting to take microbics out, you better come with a change of control premium that is sufficiently interesting and something level we're not going to be at for two or three years. And the closer and closer Kinlytic comes as well, the more interesting that asset becomes and the greater the reality of Kinlytic will be reflected in our share price. So, we see a business going from strength to -- from strong to stronger. And that puts us in a very good position as shareholders to keep maximizing value. So, yeah, we get frustrated too about the share price and we joke about it that we could announce that we cured cancer, colonized Mars and solve death and the share price of move a penny or two. But ultimately, we'll just keep winding the spring and one day all that will unfold and be reflected.
Deborah Honig
Well, investors keep saying that they want profitable growth, right? And that's what you're showing.
Cameron Groome
Yeah. Yeah. Absolutely. And the other thing, sometimes I'll joke, that the best cure for a low share price is to go buy some shares. And all of our management are material shareholders and we continue to add to our holdings. And nothing that moves the share price than a few shareholders going out and buying more.
Deborah Honig
Great. We don't see any more audience questions. Wait. There's one here. There was one. Sorry. What is the next major milestone for Kinlytic?
Cameron Groome
Ken, do you want to talk about that?
Ken Hughes
I would say the obvious one is the, contracting of the supplier, the CDMO for the money for the drug product itself, the -- finished drug. We're required at the moment to upgrade to contemporary standards the drug substance, which is the purified protein, urokinase protein, that's going forward at a pace. We have major international CDMO to drug products, now being evaluated to where one will be selected to be the final producer of the product. We expect that to happen in the first quarter of 2025 -- first half of 2025. It's not in the critical path right now, but we have three excellent candidates already jumping at the bit to work with us there. So that's probably the next major milestone. And of course, we'll be building the manufacturing capacity and going to the FDA for approval to relaunch in 2027.
Cameron Groome
Yes. And we have to strike a balance to be respectful with our partner that is a private company and their druthers would be to say nothing and just pop onto the market one day. But they do respect the need for us to, as a public company, it's material for us and we have to keep our shareholders up to date on the progress of that. But that means we can't be issuing a new Kinlytic news release every time somebody sneezes. So, it's only once or twice a year when we have a material milestone such as engaging one of these major contractors that we can provide the updates beyond our continuous disclosure.
Ken Hughes
And the project is going very, very well. The CDMO on the drug substance is doing superior work and away we go.
Deborah Honig
Okay. Now I don't see any questions, we might actually be done in just on the hour.
Cameron Groome
Wow. Brilliant.
Deborah Honig
Your wonderful marketing person just informed me that the presentation is on the website now. So, any investor looking for early Chrismas gift, you are welcome. You can check that out. There is no significant changes. I don't think just updating financial information and couple tweaks. Cameron, was there any closing comments that you wanted to have for the session? Anything that we missed that you wanted to discuss?
Cameron Groome
I think I would just say, we are very grateful always to our shareholders for their trust and support in the management team of Microbix. Our management team are very appreciative of them as well as our Board of Directors and just the wonderful staff we have, our senior management team, our managers, our staff. Everybody is just doing fantastic work and it's just a real pleasure to be able to be the spokesperson and coach for such a wonderful team. Thank you, Jim and Ken. Did you have any concluding comments you want to make?
Ken Hughes
My only comment is, obviously, we're looking quite pleased with a really good year in 2024, but we're nowhere complacent. We've been building capacity to build this business way, way beyond $25 million. And so, we're going to be you know, pet pedal to the metal to do that in the next little while to realize that shareholder value. And to Cameron's point, we're all shareholders, and we want to enjoy that in the future. So, there's going to be no taking the foot off the gas anytime soon. But we've done but we do have a great team. We have the right team to do this work.
Jim Currie
Yeah. And we're not we're not resting on our laurels at this point in time. It was a very strong 2024, but, we've already switched to 2025, and looking forward to another very successful year.
Cameron Groome
Yeah. 2024 was a record year, and I think we'll see the same for 2025 with new records for revenues, margins and so forth.
Deborah Honig
Well, thank you all for participating. Thanks to the audience for your participation and your great questions. I think we had about 30 questions today. So, like seeing that because I don't have to come up with my own. So, appreciate the help. And, yeah, everyone have a great holiday season, and reach out if you have any additional questions or would like a one on one. With that see you all next year.
Ken Hughes
Thanks, Deborah.
Jim Currie
Thank you. Thank you, everybody.