Good morning, everyone. Thanks for joining us. Today we have a presentation with Microbix Biosystems, where we're going to go through their fiscal Q1 results. With me today, I have Cameron Groome, CEO; Jim Currie, CFO; Ken Hughes, COO. Before we jump into everything, I don't think we're going to work off a presentation, but just so everyone's aware, this session will contain forward-looking statements. If you'd like to know more about those, you can find them on the company's presentation on the website, which will be updated today at some point.
The session will consist of a bit of an overview of the quarter from management, and then we'll jump into Q&A. Feel free to put any questions you have in the Q&A box, or you can email them to me. I apologize, I'm a little bit under the weather, so if I have a hack attack, my apologies in advance. I did go get tested, but it wasn't point of care, so five days later, I still don't know what I have, Cameron.
Well, case in point, Deborah, I hope you're feeling better soon, and maybe we'll get you into the lab, and we can add to our viral seed banks.
Thanks. Yeah, my bet is on RSV, but I thought I had it in December, so who knows? Anyway, more important things. Cameron, do you want to kick us off with a dialogue about the quarter?
Sure. Why don't I start with a bit of a financial overview and ask Jim to expand on that, and then we can talk about some of the operational achievements. I'll lead in on those and ask Ken to expand on some of those achievements. It's a pretty long list, and we could go well above the appointed time, but we'll try to keep everything concise. In short, it was an excellent quarter. We came in with revenues just over CAD 6 million, and that is, on the surface of it, down versus the prior year quarter. The prior year quarter included CAD 4.1 million of non-recurring milestone payments associated with our Kinlytic project, which is going extremely well, and we'll talk about. Your relevant comparable is revenues of over CAD 6 million from recurring sales, recurring products to recurring customers, versus CAD 4.3 million the prior year.
We also had excellent progress in expanding gross margins, which is reflective of excellent work from our teams, from sales and marketing through engineering and operations, in rigor on the manufacturing side, and our gross margins expanded to 62% in this year versus 49% if we exclude the Kinlytic revenues in the prior year. We also had very good control of operational expenditures, with those being down year- over- year, partly because of a lack of investment banking fees this year associated with the Kinlytic successful realization last year. Those led to a very strong net earnings of CAD 856,000, rounded to CAD 900,000 if you're rounding up, or close to 15% gross margin on the quarter. I think we are very happy with that and hope that our shareholders are too. Jim, what would you want to speak to to expand upon that?
Well I think, I mean, certainly we did see really strong growth in our, let's call it our recurring core businesses, a 40% growth. Along with that, as you mentioned, Cameron, excellent margins. We're starting to see the benefits from the efforts that are being put into our manufacturing processes, and they're achieving the margins that we have been hoping for and expecting for quite a while now. That is starting to produce a bottom line that is very strong as well. Also, during the quarter, we continued to buy back shares, and we continued to do that in January as well. Over the last first four months of the year, we've bought back about 2.5 million shares.
We've also, more recently, I guess, as a subsequent event in our notes to the financial statements, we noted the strong exercise of warrants that we saw in options in January. So, t he combination of those two have brought an additional, approximately just under CAD 3 million of cash in as well, and a recognition from our shareholders and those that participated in the private placement five years ago that we've got a really strong business right now, and they wanted to exercise their warrants, and management wanted to exercise their options too. So, a good quarter.
Yeah, thank you. Thank you, Jim. Great points. Certainly, we are active in the normal course issue of the share buyback program, as Jim indicated. Our strong financial ratios are after the impact of those purchases, which, of course, is a use of liquidity and reduces shareholder equity somewhat as we are buying back those shares. We consider that to continue to be an excellent use of shareholder capital in adding to the pro- rata ownership of each shareholder. Cash position very strong. The warrants and option exercises, of course, occurred principally subsequent to the quarter end for Q1. Those numbers are not reflected in our cash balances at the end of the quarter from December 31, 2023. That is, in fact, on top of and in addition to.
It's nice to see a little bit of recognition of the really great operational progress of the business that drives these financial results, with the share price beginning to reflect a little bit more of the fundamental value of the company as we've seen the share price move up sharply from lows at the end of October to crest slightly over CAD 0.52 on some of these announcements, and then consolidate a little bit in the high CAD 0.40's currently. The share price is tail-wagged by the fundamental dog rather than the other way around. I'd remind everybody that in terms of our announcements, we announce things when they are done. We don't announce typically intentions. The only exception to that would be something that we discussed in January that I'll get to, the importance of.
During the quarter, we had some excellent milestones. In the fall, we achieved our IVDR accreditation for sales in the European Union. This is a big upgrade in the rigor of the in vitro medical device rules in the European Union, moving from directives, softer and less rigorous controls on how medical devices are able to access that market to the regulations. IVDD has disappeared, and IVDR has come in. Many companies have had great difficulty in moving to that higher level of accreditation. We have done so successfully as we announced in the fall. We are also very conscious of expanding the total addressable markets that Microbix can access. Of course, every day we are working to sell more products and services to current customers, and we are looking to add customers. We have also been working very hard to expand our total addressable markets.
As evidence of that, I'll point to three things. One is the first quality assessment product we fielded in the genetic testing market, our QAPs for an urgent point of care genetic test with a partner in the U.K. We have also begun to field products in oncology, moving into QAPs on the formalin-fixed paraffin-embedded tissue sample mimetics, very high-end stuff. Say that three times quickly, it's a lot of fun. That drives us into the field of oncology. Moving beyond our traditional specialty in infectious disease into being able to address genetic testing markets and oncology markets. Unbounded potential in terms of driving sales growth in that field. Another exciting area, and this is the sort of exception we have made in terms of not disclosing projects until they are done because of the broader strategic significance of this. This is starting our recombinant program.
Microbix has been a world leader in the production of native or natural antigen products as test ingredients, but had not moved into synthetic or recombinant antigen capabilities in production. We now have the resources, both financial and people, to do that without it being an insurmountable lift. We announced that intention in January, which in turn expands massively the total addressable markets for our antigens business. We will ensure that it continues to grow. As Jim indicated, its performance was extremely strong in Q1, and we expect that strength to continue as we do the growth in the quality assessment product business. Lastly, and I'll ask Ken to expand on these various points, the movements of QAPs and expanding that market, expanding the addressable markets in antigens, but also to speak to Kinlytic.
Without too much spoiler alerts, Ken, I think it's fair to say that our Kinlytic Biologic Therapeutics program is progressing extremely well also, and that is a big value builder for Microbix. It would have been far too heavy a spend for us to support as a small Canadian public company, but through partners, we're making it happen. This is getting ever closer and is going to be something very transformative for Microbix within the next couple of years. Not so far away now and getting closer every day. Ken, maybe you could expand on some of the successes that the teams have had and just cover the waterfront.
I mean, starting in the core business, right? We've talked a lot about capacity building. Capacity building is not just square footage and headcount, it's also capabilities and time to deploy those capabilities, and that's what we've been doing. You can see how we're servicing the market, how we're doing growth, but also we're building margin by reducing costs through efficiencies, using our quality management system, reducing the testing load to QC, and also increasing yields, and then really reducing to almost zero batch failures. These things happen, but the reduction in batch failures has led to this margin increase. We're deploying that capability in all aspects of our core business. That's why you see growth, and we have much more capacity than that, so we're ready to go and deploy that capacity going forward. Speaking of capacity, we're all scientists.
We're experts in synthetic as well as native biology, and therefore the recombinant program with a bit of power behind it is going to move quickly. You can expect to see the first products coming out in the next few months, and certainly several, both in prokaryotic in bacterial expression, and eukaryotic meaning mammalian human cell expression before the end of the fiscal year. As Cameron, quite correctly says, that addresses multiple new large and growing markets and also creates internal customers who are not the best of them as well. We are really setting the stall for rapid growth, as you already said, and you're already seeing the benefits of that. I'll switch to Kinlytic. I have nothing to say other than what I said last time, which is the relationship with Seqirus is fine. Everything is on schedule.
There's no change to the timeline. We're moving forward nicely with the international CDMO, which is working on the drug substance, which is the purified product. Seqirus has just, in collaboration with Microbix, identified the CDMO, the contract manufacturer who will fill the finished product and package it. That's just being papered right now, and that's another multinational driving force company going forward. We have had lots of discussions about, because we obviously were doing catheter clearance right now, but we're not stopping there. We're already talking about the next indications, the next jurisdictions, looking at stroke, looking at heart attacks and things of that nature, pulmonary embolism and deep vein thrombosis, the bigger indications to drive this franchise to multi-billion dollar opportunities.
We have the technical capacity to do that, and we have the technical capacity to upgrade all these processes to contemporary standards to maximize the margins associated with that. The top line and the bottom line get maximized by what we're doing. Like I said last time, I haven't got much bad to tell you. Everything's on schedule. We're going nicely. I can't speak highly enough for the technical team and Microbix, the manufacturing, the R&D, the QC, the QA, and everything else around it, the IT group. We're driving everything as it should, as we said we would, and we're going to be successful.
I muted myself. That's amazing. After all these years, we still do that. Ken made some great points. I mean, the quality of the team that we have is just superlative, and we can't say enough about them or be thankful enough. We're moving; we've, I think, created a very positive culture where people enjoy working at Microbix and the dynamic and the team spirit. We're moving to, even in our compensation systems, a higher proportion of variable compensation that's performance-driven by design. That includes performance-driven and KPI-driven bonus systems. We have, of course, our ongoing option plan, which embeds and really incents people to do their best and become eligible for those by moving up in the organization. We're seeing the benefit of those designed systems in that.
I just learned yesterday at our senior management team call that another scientist who'd left Microbix is coming back. We have people that do enjoy working with us, and I just think we've created a culture that works, and we're seeing the results of that as shareholders. Some of the other things I'll mention, just on cutting edge, for example, in January, we announced, speaking of synthetic biology, our work on H5N1 influenza, the bird flu that continues to simmer in dairy cattle populations and in poultry populations. We have created a forward-looking safe synthetic biology construct that can be used in a QAPs to check whether the existing flu tests, whether they're commercial FDA-approved assays or lab-developed tests, can actually detect H5N1 flu, which is, of course, critical to managing any emerging viral outbreaks.
Proud to be working on that with one of the global leaders in that field, American Proficiency Institute, that has 20,000 clinical labs subscribed to its programs. Not all of those in the respiratory category, but it just goes to show how we are very much at the forefront of this kind of innovative work in public health and in individual health. You know, witness Deborah's difficulty in getting a definitive diagnosis in a timely manner for a respiratory virus. I mean, this shouldn't happen in the 21st century. It's bonkers. We are taking a very strong leadership role even in policy development and making sure that these next-generation diagnostics are used to the best possible effect. That can be in flu.
In the genetic testing field, the quality assessment product we've launched there is a rapid emergency point of care, supports an emergency point of care test to detect whether people have a gene variant that will cause them to go profoundly and irreversibly deaf if they are given even a single dose of a very effective antibiotic. If you've got a bloodstream infection that could kill you within hours and the physician says, "This is the best possible drug, but I don't know if you'll go deaf," what a difficult challenge of a decision to make. A test that costs tens of dollars, if it's properly controlled and has the quality systems can run it, can make that difficult determination much easier and much more effective.
Again, the kind of leading-edge work that we're supporting with our company drives the thought leadership and drives more customers to choose to work with us as their preferred partner when they're launching these innovative next-generation diagnostics. Just indicative of why our sales are growing, why our margins are improving. It's both the outward-facing and the inward progress that we make on that front. Coming back to the quarter, I'd say it's an excellent quarter. We're very pleased to be in such a strong position. It's by design, not by accident, and we'll continue to drive forward on that basis. Jim, did you want to make any further remarks before we start to field some questions from investors?
No, I don't think so, Cameron. I think you've done an excellent job of covering where we are. I mean, it's been a strong quarter, and we're looking forward to the rest of the fiscal year. With our business, we do have a good, strong order backlog. It gives us an indication of the business going forward, especially in our antigens business. We've got a good, strong backlog right now. We're looking at a good second quarter and into the remainder of the year.
Yeah. No, that's great. We've sort of talked about target range in the 20%-40% revenue growth. We came in at 40% on the button for Q1. Please don't set that as the benchmark for every single quarter. We're growing revenues at an outsized rate, but we're not magicians and mathematical geniuses setting the quarter at that number.
All right. You ready for some questions?
Sure thing, Deborah. Fire away.
Actually, maybe I'll share this with the audience because I was telling you before, Cameron. The only reason I went to the doctor is because I had six respiratory infections in the past year, and I thought, for sure, something must be wrong. I did a chest X-ray, which came back totally fine. The doctor told me that's not unusual anymore to have six chest infections a year. She said since COVID, the rate of respiratory infections has skyrocketed and that I shouldn't be concerned. Apparently, this is just the new normal, which is crazy. Anyway, I remember before COVID, I never got sick, really. Now I'm sick, I guess, six times a year. Anyway.
I'll see what I can bring. We're doing some investor conference and meetings in a few cities next week. I'll see if I can bring some immunochromatography strip tests with us and see if we can pin that down for you.
Yeah, we're glad the investors don't want you to bring me.
I think we might be changing plans if you're not better by then.
Oh, I'll be fine. So, going through questions, there's quite a lot, so I'm going to try and keep it thematic. I'm going to start with QAPs. If anyone has questions about QAPs, please start entering them now so I don't have to jump back. What percentage of QAPs revenue relate to assays currently in development versus assays that are commercial?
Great question. I'd have to revert back for a precise split. I don't have that at my fingertips, but the vast majority of sales of QAPs in the first quarter were driven to fully commercial programs. There was relatively little development revenue in this particular quarter. The majority of sales were to the proficiency testing and accreditation or external quality assessment agencies, with some sales to ongoing partnerships for training new sites and installations and small ongoing order flow from clinical laboratories around the world. I would say we were likely less than 10% or less in terms of development revenues as the proportion for the quarter. Jim, does that sound about right to you?
Yeah.
Okay. You're on mute. Yeah. Thank you. Okay. Next, Deborah. Oh, Deborah, you're on mute now.
Okay. Now I'm back. Was the reduced activity from test manufacturer that impacted your QAPs revenue transient reduction in activity or likely to continue, i.e., a canceled program?
I would say firmly a transient reduction related to timing of programs. We expect from that customer and others, we expect orders of training panels and pre-launch and launch inventories in our fiscal Q3 and Q4. That, of course, the future is always subject to risk, but that is our firm expectation driven by the communications with our customers.
Right. I see that there was an add-on question, which you already answered part of, which was, what percentage of QAPs revenue relate to assays currently in development versus assays that are commercial? The second part of that is, where do you expect this ratio to be at the end of the year?
I would like to see it come up a little bit. I think the development work, we have a variety of customers for whom there are pending development projects. I think that proportion will increase, but I think it would still be less than a quarter of overall QAPs revenues. Just keeping in mind, Deborah, what you're reading, development projects, oftentimes we will charge a fee for such development work if it's not an off-the-shelf product to cover our labor and materials, but that's not the end game for that. A project starts, it may have revenues in the tens of thousands associated with development work. That follows by validation lots.
Typically, there are three smallest possible commercial-scale production runs to validate the repeatability and start to generate any specific stability data that might be needed. There is launch inventory that is generated, and then the ongoing commercial pull. It can take many months for a development project to translate into ongoing commercial sales.
Got it. Can you provide more color on the slowdown and delays in QAPs sales?
It's a delicate question. I prefer not to kiss and tell with regards to customer programs, but I think it's fair to say that a customer that had been planning to develop a whole portfolio of assays in parallel has moved to serial development of a narrower front of tests in succession. It's that change to strategy that's driven some of the short-term reduction in QAPs revenues, just fewer production lots, validation lots being produced in parallel.
I have a couple of QAPs questions via email. Regarding the delays at one of your customers, can we expect these to be gone next quarter, or what time frame are we talking about?
I don't think those will be gone next quarter. I think we'll start to see that in Q3 and Q4 if that particular partner is moving forward on time. Of course, when a new assay or program is launched, you have to count back months from that for the production of product to support that launch. If a launch is to take place toward the end of the year, for example, in December, we've got to be thinking about production of the supporting QAPs associated with that through the early part of the fall at the latest to do that. The products have to be designed and validated well before that. You're counting backwards minimum of one quarter, maximum three quarters, likely from that program launch.
What gives you confidence to guide for 20% plus growth in QAPs? Are there new projects on the horizon?
Yes, there are new projects on the horizon with multiple customers, and we have continuing growth from almost every customer in our QAPs field. It really comes down to issues of timing quarter to quarter. Oftentimes, too, this happens with our antigen business as well. Depending on which side of a quarter end a shipment organically falls upon, it affects the quarter-to-quarter revenue. We used to see much more quarter-to-quarter volatility in the sales of the business, but as we're growing the customers and the product line and the product categories, that's been starting to smooth out. There's always an element of that.
I see one last QAPs question. Does CAD 1.6 million a quarter in QAPs seem sustainable? Is there any Quidel Savanna revenue in the budget for 2025?
I'll address both questions. Absolutely. That is more than we expect and are targeting significantly in excess of those sales, particularly in the back half of the year. Recall that last year, we did about nearly CAD 7 million in sales of QAPs over the full year. We are targeting a higher run rate than CAD 1.6 million a quarter, of course, and we're targeting higher QAPs sales in 2025 fiscal than in 2024. That falls from a variety of customers, including Quidel Ortho.
Moving on to antigens, was the 118% growth in antigens due to customer order lumpiness or other one-time things, or should this level of antigen revenues be sustainable?
I can cover that one off.
Yeah. Go ahead, Jim.
Yeah. There was a combination of things. I think I would say that the antigen revenues of Q1 last year were probably weaker than we would have typically seen. It got enhanced this year by some really strong growth. I would expect that for the remainder, at least our outlook for the year is that the antigen business should be staying at comparable levels to what it was in Q1 for the remainder of this year, at least.
Yeah. No, thank you. Thank you, Jim. This growth is in part driven by new assays in new geographic markets pulling a real pull of antigens for us and validates the premise that we've talked about that new geographies is a means of growth for the current antigen portfolio. Now, with our recombinant program, we're expanding the antigen portfolio. A wonderful thing is that our QAPs business will become the first customer for the new antigens that we're creating. As we validate those for use in our own product line, those products can be successively added to our catalog.
To not build our catalog and build our margins at the same time and build our expertise for new opportunities as they come down the pike. We have mature native antigen sales, and we're growing those in geographies, but we also have the new initiatives to add to the portfolio of offerings, which will continue to grow also.
Yeah. It also goes a long way to making sure our supply chains are bulletproof with regards to QAPs product. Why, for antigen-based QAPs, why buy from outside when we can create these internally?
I have a couple more questions specifically related to the recombinant antigens. Native antigens used to set you apart from the competition. What gave rise to the need to start producing recombinant antigens?
Great question. Often, there are many instances in which a native antigen will provide an immunoassay, a test looking for antibodies in your blood, better sensitivity and specificity than is possible with a recombinant antigen. There are instances where a recombinant is sufficient and can be a better economic solution, can be a cheaper solution for that. We were working in that high-end element in the native antigens, and this enables us to go into broader markets. Also for emerging pathogens, there can be cases where either the risk class of the pathogen precludes doing a native production, or it is more efficient to do recombinant. This just expands our addressable markets. Ken, do you want to expand on that?
Yeah. I mean, all of what you said is correct. To add to that, there are just some organisms you cannot grow in the native sense. You can't do it in a commercial way. With these capabilities in synthetic biology, we can create flexibilities of that or individual antigens which are germane to our antigen business going forward. It's not that we're in any way undermining our expertise in native antigens, and it still allows us to stand apart from everybody else. We're just adding additional capabilities. Also, we could increase potency of products by mixing them together in appropriate strategic ways as well. Just adding to the capacity which we can apply to these opportunities. Yeah, that's the only thing I would add to what Cameron said. It's about capabilities.
Yeah. Capacity and capability is really the two areas that we're looking at there. As we look at recombinants, nobody knows better. We have all the tools to analyze what constitutes a good recombinant that has the right immunogenicity and the right properties to be recognized by the necessary antibodies. It is really, again, deploying expertise we already have in-house in the best possible ways.
Yeah. We deploy that expertise in the QAPs all the time. We are now adapting it to new opportunities with the bandwidth to do it. That is going to just create more opportunity going forward.
Yeah.
You would say you have competitive advantages in recombinant antigens?
I would say we have competitive advantages in knowing what a recombinant antigen needs to look like and needs to be. Now we're building the capabilities and capacity to do that at commercial scale, and we're doing it at a hell of a clip.
How much of Q1 antigens revenue was actually recombinant antigens?
Very, very little. This is just a newly announced program. We have done a few recombinants in the past on request of customers, and we do sell a little bit. The vast majority of sales in Q1 and in every quarter have been native product historically.
Do you expect margins on recombinant antigens to be lower than your other products?
Good question. I think there will be a range of margins on that. If there is something that is more widely available, of course, you will have greater difficulty distinguishing yourself. If we are able to, as we expect, create value-added and unique products, then those will have margins comparable or better than what we generate off the native program. Ken, what would be your thoughts on that?
It's completely variable and depending on the individual protein and whether or not you express it in bacteria, which is generally easier, or in a mammalian or human cells going for a eukaryotic expression. Also, the nature of the individual protein or organism you're expressing has its own idiosyncrasies with regards to yields. In some cases, the margins will be massive. In some cases, they'll be less massive. In many of those cases, you won't be able to do it by any other route anyway. Basically, you are deploying differential expertise where it makes the most sense to do it.
We'll have a breakout call, I think, on some of the nuances there. I'm not going to let Ken get into too much genetic engineering on this call.
Yeah. I can nerd out now and again.
Yeah. Yeah.
Can recombinant antigens cannibalize native antigens market?
No, not for the products we're looking at. The product line in Microbix in most cases would have been cannibalized a long time ago if they could be. We will occasionally see movement as assays are redeveloped, but it's a fairly well-established business that we have. We would have to look at the performance and the economics before we would swap over a program. There may be prospects, as Ken has indicated, to enhance the potency of a native product by mixing in part of a recombinant. That would be a capability that we would have fairly uniquely.
The other aspect is that the non-recombinant products that we already have are very sticky. Across validation, to drop in a recombinant may be more work than people would want to do. To Cameron's point, if it was that easy to do, it had already been done. We do not expect to lose anything of any significance from our native antigen supply; that is entirely additive to the current business.
Yeah. Thank you.
Sorry. Previously, you said you expected antigens to grow at 5%-10% per year over the long term. With your new recombinant antigen capabilities, do you expect this growth rate to accelerate materially?
Over time, yes. It opens up more opportunities, new opportunities, broader opportunities for that business. We have been seeing an acceleration of growth based on new geographies, principally uptake of our antigens into immunoassays in Asian markets. The 5%-10% was more the Western European and North American growth rate with a higher growth rate in new markets. Now, I think we can start to consider a higher growth rate in aggregate for our antigen business based on the decision and the support of the board to move forward with a full recombinant antigen program.
I see one last question on recombinants. What sort of CapEx do you foresee spending on this business?
Surprisingly little. As we look at this, and we've got a great board of directors, and they challenge in the right way the management team to think about these growth opportunities. They put our feet to the fire across 2024, saying, "What are the initiatives you need to think about, guys, that will accelerate growth? And how does this look like from a CapEx point of view, from a spend point of view, P&L balance sheet up and down the line?" We brought forward a series of recommendations to the board for review at our annual offsite. Do not get excited about the offsite. It is in Mississauga, nothing too exotic.
We reviewed those, and we received the go-ahead in November to move forward with that, completed our internal planning, reallocating teams, setting budgets, and thereby announced the go-live of that program in January. It is really good. It's going to be we estimate a spend of perhaps CAD 500,000 a year on that. Not that if you were starting this from Greenfield, it would be millions and millions and millions of dollars potentially. Because we already have the expertise and the infrastructure, it's much less costly for us to do. That's a unique situation for Microbix.
Yeah. I mean, it has to be remembered that we have many excellent molecular biologists, molecular virologists, and probably even biochemists on staff already that deal with our core business and the native antigens as well as recombinant QAPs. This is about bringing expertise together and letting it loose. We're already seeing great progress.
Yeah. R&D, manufacturing, QC, QA, all this infrastructure is already in place. It is adding that increment and focusing the energy. This is a wonderful thing.
I had a couple more general questions about financials. Do you feel like 60% plus gross margins is a sustainable level going forward?
Depends on just how wild Jim goes on the spending, I think. Jim, why don't you take that question?
Yeah. It's a bit of a tough question. With the antigen business, mix of products can have a significant impact on the margin in any particular quarter. Q1 was pretty favorable, and 62% overall was a strong margin. Would we expect to be in the 60%-65% range for right now? Probably not. I would say the high 50s is sort of where we're sort of expecting to be for fiscal 2025. You could see a 3%-5% variance plus or minus on that, depending on the product mix that takes place during a quarter.
We're not done on the optimizations across product lines. Incrementally, that will move forward. Of course, that also is affected by pricing policies and negotiations as well as product mix.
Yeah.
Do you expect operating expenses to remain relatively stable at this level for the remainder of the year?
My first blush would be yes. Jim, why don't you take that one?
Yeah. I mean, in terms of Q1, again, probably not at that level for the whole year. Certainly, we're not anticipating anything significant in the way of operating expense increase during the year at this point in time.
Yeah. I mean, we do have a bit of creep with cost of living adjustments for staff and so forth. These are not sea change items. These are more incremental that you'd expect given the current inflationary environment.
Yeah. We have the majority of the capacity we need to drive what we need to do. Any changes will be minor.
Yeah.
Okay. Getting down to the last couple of questions. Excellent results and progress. Thank you. Of all the announced initiatives and excluding Kinlytic since it's further out, which do you see as potentially the most impactful for 2025?
For 2025. Interesting. All these programs will have a far greater longitudinal impact than just in 2025. I would say the most strategic for me, and this is excluding Kinlytic because the question said to exclude Kinlytic, I think the moves into QAPs areas beyond infectious disease is very important for us in opening up markets in oncology and genetic disease is very important. I would say that moving the antigens opportunities into the recombinant category as well as the native antigen category is similarly strategic. Ken and Jim, what would you want to say there?
I would agree with what you've just said. There's a steep linear growth in antigens and a potential logarithmic growth in QAPs as we move forward. We've discussed many times before. I expect all of those initiatives to materially increase through 2025, but certainly beyond that. This is a longitudinal opportunity on multiple longitudinal opportunities as we go forward.
Yeah. Jim, what would your thoughts be?
No, I don't have anything to add beyond what you and Ken have just outlined.
Okay. One thing I'll add, as I'm just considering the question as well, is that we are already in the QAPs side. We are already generating good margins. These are good margins driven by relatively small product volumes, lot sizes. The huge lot size volume opportunities have been elusive in the timing of lighting those off. As we get more customers lined up for these big volume opportunities, that's where the steep linear growth that Ken describes for QAPs can go exponential.
The fact that our business is already profitable and demonstrating good margins on relatively small lot sizes where the setup and takedown and line clearance and everything kills you on the margin is very, very positive. As we move to realize some of these big volume opportunities, we'll see at that point, I believe, we'll see both margin expansion and big revenue growth. I can't tell you exactly when because that's out of our control. We are lining up more and more of such opportunities.
I can certainly see that from an operational perspective. There is no lack of focus on increasing margins by operational efficiency. That is something we are really focused on going forward. I think we have seen that evidenced in this particular quarter, and we will continue to see that.
Yeah. A lot of the work we're doing now is this sort of custom work. It's relatively low volume still. If we're able to roll out 10 million Model Ts, and they're all black, obviously, the margin shoots up associated with that.
Okay. A couple of final questions. This one is number two in the question in the box. I'm a little bit confused by it, but I think they're asking for an update on a partnership or contract side with a drug manufacturing organization. Is there an update on that, I think, for Kinlytic?
Let me take a stab at that, Ken, and maybe you can expand on it. There are several critical components to the Kinlytic program. We have tremendous capability in cell culture, which is the basis for manufacturing product. But we are not a GMP drug manufacturer. We're a virology facility. You can't be doing that work for creating product for clinical use in our facilities. The two largest segments of project spend associated with Kinlytic are, as Ken delineated, a contract drug manufacturing organization or CDMO to make what's called drug substance. That's the active protein ingredient that is the active ingredient of Kinlytic. That contract was signed in the early part of 2024 and has been proceeding very well since that time. That's certainly well in excess of $10 million spend by our partner on that program.
The second CDMO that needs to be brought on, the second principal one that needs to be brought on, is what's called for drug product. This is the process of actively formulating the ingredient with the correct excipients, lyophilizing or freeze-drying that product, having it in a final vial format ready for clinical use. That is, in turn, a multimillion-dollar contract with already qualified facilities to do that work. That will be the next major evidence of progress.
As is our normal practice, we'll announce that when that is completely signed and done as evidence of progress. The level of disclosure will be a negotiation with our partner as they're a private company and their preference would be to say nothing ever and pop onto the market one day. We have public company reporting obligations. There's a bit of to and fro that needs to be done there. But that's something we do expect certainly in 2025, just to be very clear, that will happen, I believe.
Yeah. The timeline for the whole of the Kinlytic project has not changed at all. There's another aspect is what Cameron just described, describes the opportunity for small dosing, clearing catheters or preserving flow-through catheters. There are other indications where process upgrades will be needed. I think the group knows that Microbix has been involved with urokinase for decades and has manufactured it in a development sense many times. We are going to participate in that scale-up to address things like pulmonary embolism and deep vein thrombosis going forward. It is every intention to do that. Yes, we are currently providing technical counsel to Seqirus as they move forward. We are going to continue to be technically involved through all aspects of this project.
Yeah. The manufacturing process upgrades that can be done once there is in-dated, validated drug available to do comparability analysis, we can then modernize manufacturing tremendously. Frankly, I do not think there is any organization that has better expertise in the precise areas that are required for that process than Microbix. We are really excited about that.
That is right in our technical sweet spot.
Yeah. That is critical for enabling Kinlytic to, as Ken has indicated, move beyond the catheter clearance indication, which does not use a lot of drug-active substance, back into the systemic treatments of pulmonary embolisms and deep vein thrombosis, peripheral arterial occlusions, and other such clots that use a lot more drug. You have to manufacture it much more efficiently. That is where we can bring our expertise to bear to realize those opportunities, which are potentially massive.
One more Kinlytic question. Please remind us, as well as the Kinlytic manufacturing steps, what also needs to be done and how long will those steps take?
Ken, do you want to just do an overview of the process front to back?
Yes, absolutely. We grow cells. It expresses the urokinase, which is the active in Kinlytic at a commercial scale. We purify that product. We put it into the lyophilized or freeze-dried form, which is stable, packaged, and labeled for distribution. That is the first thing that we will be doing. We are upgrading all the process technologies to contemporary standards, as expected. That is what we have discussed with the FDA. We have to compare in that analytical sense with the previously marketed product. Recall, of course, that Kinlytic, which is the original Kinlytic from Abbott Laboratories, was a standard of care in these indications for multiple decades. There is absolutely no chance of clinical failure in this product. What we are doing is showing it is sufficiently comparable to the previous product going forward.
There's a good chance we'll be able to do that only with analytical work. If that's not the case, we would have to do a small clinical trial. We're talking about a very quick six-month, 300-patient trial, just from a safety perspective. Again, there's no chance of clinical failure. If there's some excursions in the biochemistry there, that would play into the regulatory process at six months. It would still fall in 2027. Everything's quite mechanistic going through. It's about the analysis of the product. It's about bringing it up to contemporary standards in manufacturing, which we do, which all our CDMOs do. We're just moving forward kind of from an engineering perspective right now. It's going very well.
Yeah. Thank you, Ken.
A couple more fun questions for you. Have you experienced any significant growth in orders because of tariffs potentially coming into effect?
No, not as yet. I'm just thinking. No, not so much. Certainly not in the Q1 period. We did not. In Q2, really, we're watching this carefully with our customers. Much of our revenues are denominated in US dollars, as everybody knows from our notes to financials. Not all of our product is destined for end use in the United States. There's a much lesser exposure than that in terms of the proportion of revenues that could be affected. Most of our products are quite unique and are sole-source products for our customers. It would impact them directly without an alternative to do much. I think some of our most generic products, like flu in a vial, for example, is somewhat more generic. Those could be affected. I think you're looking at direct exposure, perhaps 5% of revenues could be affected by switching suppliers.
Beyond that, we would work with our customers on mitigation strategies, whether that's, "Do you really need this shipped into the United States, If you're using it in manufacturing in the U.K., for example, why don't we just ship it directly to the U.K. and you can do the QC there?" There are lots of different procedures we can take. I am not going to get too much into tactics on addressing that. We will certainly, it will be unpleasant, but I do not think it will be devastating to us.
I had one other question, which was any impact or any anticipated impact on margin?
Yeah. The margin, our initial short-term, we might see a couple of points of impact on margin. If they persisted, that might be twice that. So 2%-4% is my best guess at this point. I think the bigger question is, how would margins be impacted by countervailing tariffs? Oftentimes, we're ordering supplies and materials from a distributor or wholesaler in Canada, but we don't know where the products necessarily are coming from that they're supplying us. We'd have to do a more—we're in the midst of doing some analyses on our vulnerability to countervailing tariffs in this respect.
One last question that I see, Cameron. Other than share buybacks, what do you intend to do with the pile of cash that you've built up?
It is a great question. It is a high-class problem to have. We will continue with share buybacks. CAD 15 million, which is about what we have in the bank currently, is much bigger than Microbix has been accustomed to in the past, but it is still laughably small in the big scheme of things. We will continue to be active in share buybacks. I think now that we have our ERP system fully lit up with Jim's team and excellent progress on our digital quality management or EQMS systems, it becomes a little more practical to look, are there brilliantly accretive and strategically valuable acquisitions? If we identify those, it starts to open up that opportunity as well for us, particularly with our share price not being quite so low, using a combination of cash, equity, and potentially even banking lines.
We will keep our eyes open and see if anything significant comes along that would further add to our capabilities and capacity from an acquisition point of view. Down the road, it may not even be beyond the pale to consider a dividend. That is not something I have discussed with the board. This is just me riffing. I think we will not permit a large amount of cash to just sit there and not be effectively used. Again, having in the global instability that we see as we are looking at more customers making us a critical sole-source supplier, having some cash on the balance sheet and demonstrating staying power is an advantage too. We will not be carelessly running around to sling our cash at the wrong opportunities.
There are no big cash bonus for IR, Damn.
Sorry. It's just not on the table, Deborah. My apologies.
Okay. That is all the questions that I see. Was there anything that you wanted to cover today that we did not get to? Any final thoughts or comments?
I would just say we've gotten the company to a very strong position by design. We're going to continue to build strength and build fundamental value for shareholders, which I hope and I believe that we're demonstrating and will continue to demonstrate going forward. Thank you to our board. Thank you to our very talented staff and to the shareholders for all your support. That goes to our customers and suppliers too. Just very thankful. I think this quarter reflects good fundamentals.
Okay. Thanks to you three for enduring me and my raspy voice. Thanks to the audience for all your questions. If there's anything that I didn't ask or that you wanted to follow up with me afterwards, feel free to send me an email and get you a one-on-one call or get whatever questions answered that you'd like. I hope everyone has a nice afternoon and a nice long weekend.
Thank you, everybody. You take care. Bye.
Thanks everybody.
Thanks, Deborah.
Bye.
Take care.