Morning, everyone. Thanks for joining us today. We have a session with Microbix to discuss the Q2 results they put out this morning. You can find those on the company's website on SEDAR, and the press release probably was sent to your inbox. Let's hope. With me today, I've got Ken Hughes, COO, Jim Currie, CFO, and Cameron Groome, CEO. The format of the session will be a review of the quarterly results by Cameron and his team, and then we'll open it up for Q&A. Feel free to start putting your questions in the Q&A box if you'd like, or you can email them to me. I don't believe that we're going to work off a formal presentation today, but as always, this session will contain forward-looking statements.
You can find more about those on the company's website, on the presentation on the website, which I will update later today with the results. With that out of the way, I'd like to turn the mic over to Cameron Groome, CEO. Hi, Cameron.
Hello, Deborah. I'll start by taking myself off mute. It's always a good start for these things. Thank you very much, Deborah, and Jim and Ken for joining us, and for a second, Deborah, as well. Thank you to everyone participating for taking the time this morning. Very pleased to be reporting our results for the second quarter and first half of Microbix's fiscal 2025. In these periods, the three and six months, respectively, we've demonstrated solid sales, excellent gross margins, and material net earnings, all those achieved as we've been continuing to build out the capabilities and capacity needed to successfully engage with the largest multinational diagnostics companies and PT EQA agencies and clinical lab chains.
Our Q2 results, specifically, we had CAD 5.3 million in total revenues, strengths in our antigen or ingredient test sales business over the quarter, and slower sales of our quality assessment products due to a few one-off factors. We had excellent gross margins for the period at 60%, up a full 7% gross margin over the prior year. As expected in the second quarter, we had geared for this level of revenues to generate effectively a break-even result, which is what we achieved for the first half, total revenues of CAD 11.4 million, gross margins up by 10% year over year. Very strong progress there and materially positive net earnings of CAD 900,000, which, while we do not publish our budgets, both figures were in line or ahead of what we had targeted for the six months.
Jim, did you want to offer any further color on the Q2 or first half results?
Yes, Cameron. I think you've covered the key points, but certainly the one area that I'm happy with, and I don't get happy easily, as these two guys know, but I'm happy with is the gross margins and the cost of sales of the products, especially on the antigens business. We've put a number of processes in place within our antigens business to improve our margins, and we've seen that come through in spades over the last year. That is an excellent one. We've also, in terms of the quarter, had a good strong quarter from cash and available credit, I guess, during the quarter. We exercised, or people exercised, $2.7 million worth of warrants and options during the quarter. We utilized some of those funds to pay down our mortgage of CAD 1.15 million.
We also worked with our bank to increase our credit line, doubled it from CAD 2 million to CAD 4 million. Overall, a good strong quarter, and we see that our balance sheet is in probably the best shape it has ever been in. We had good strong ratios at the end of the quarter with our current ratio at 9.36 and our debt equity ratio at 0.27. Overall, an excellent quarter and an excellent half.
Thank you. Thank you very much, Jim. I think that's a great point to discuss the financial strength of the company, just how we have been building up our liquidity to keep executing and have been adding to our capabilities and capacity in that process and ending up still stronger. We've also, of course, bought back a material number, continued to buy back a material number of shares, and that is a use of proceeds and capital that also serves as a holds back the improvement of those ratios somewhat as we're using equity to buy back shares and some of our surplus liquidity. I think that's a wonderful summary, Jim. Thank you very much, and we'll leave time for more questions on the quarter should people want to field them into the Q&A queue.
We've also done, I think, some excellent operational work in Q2 and over the six months. Some of the things that I'll point to there, we have commissioned for the first time recombinant capabilities are coming in. Our specialty has been in native antigens, which are the native viruses and bacteria grown up, purified, and inactivated for use as ingredients in immunoassay tests. There are cases where synthetic or recombinant test ingredients can play an important role. Onboarding these capabilities, as we announced in January, is now ongoing, progressing very well, and opens up substantial new addressable markets for our test ingredients business and really enables us to offer a broader suite of services to our customers.
We've also made some excellent progress in our QAPs business with demonstrating our global leadership in screening for human papillomavirus, so screening for cervical cancer, and enabling globally the move from the 1950s, albeit very valuable, pap testing methodologies, which rely on cytology and pathology, into molecular diagnostics, looking for the genetic signature of the virus that will drive that cancer formation over a period of many years, 5 to 10, typically. Our leadership there is enabling that transition globally, as evidenced by our Indo-Pacific alliance with the Australian Centre for the Prevention of Cervical Cancer and other global organizations across the Indo-Pacific. We've also demonstrated our leadership in emerging pathogens with our work with the H5N1 virus and developing synthetic constructs to be able to determine could labs' existing tests pick up the emergence of H5N1 into human-to-human transmission and more broad spread.
God forbid that happen, but we're enabling labs to validate whether their lab-developed or commercial tests can do that detection with our partner API and, again, demonstrating technical leadership. We have also been opening up new addressable markets in our QAPs business, starting work in genetics testing with a very exciting point-of-care genetics test program out of the U.K., and in oncology, working to help in the emerging field of molecular pathology, as there is really a blending between pathology and molecular diagnostics, and all of those innovations need to be validated, and Microbix, again, taking a leadership role in doing that. Lastly, before I hand the baton over to Ken for a bit of an operational update, I do not want to neglect mentioning the excellent progress that is being made with Microbix' therapeutic drug asset.
This is the thrombolytic Kinlytic urokinase, a program that would have been too much of a financial lift for Microbix to undertake on our own and have been successfully partnered with Sequel Pharma, a portfolio company of a globally significant US-based private equity firm that have all been wonderful partners in advancing that. We had a very substantial milestone just announced a short while ago on May 5th. Outside of Q2, it is still relevant for this discussion where our partner has undertaken another major program step, providing the incontrovertible evidence that this program is progressing well. I do not want to steal all your material, Ken, but maybe you could dive in a little bit more deeply on some of the operational progress that is being made.
Sure. The operational side of the business, I mean, the operations of the business is humming along very nicely. We've spoken about building capabilities and building capacity to support our growth going forward. That is exactly what we're doing. That is exactly what we've done, and that is what we'll continue to do. From the perspective of manufacturing, the manufacturing process upgrades we've put in place in the last little while using operational excellence are manifested in the numbers in the margins. We're getting much better yields, bigger yields in our antigen products. We're getting a lower scrap rate, and we're going to be driving on from there. As I say, that is represented in margin gains to a certain extent, and we're going to continue doing that.
The use of the digitization that we've done, the electronic quality management system and the enterprise resource planning software has allowed us to, and of course, all the automation we've done in the lab as well in the last little while has allowed us to reduce the workload and the drudgery to quality control, to quality assurance and regulatory and other manufacturing staff. That, again, is manifested in capacity of the business and in the margins that you see in our financials. The new CL2 laboratory, containment level 2 laboratory in building three, is humming along nicely. It's fully operational, and there's good testing and products coming out of that as we speak. The high-throughput filling line is online and operational.
There are new QAPs quality assessment products coming from the molecular side, in the protein side, in the formalin-fixed paraffin embedded clinical specimen side for oncology and molecular pathology. They're moving along. The recombinant aspects are going really well. Our first recombinant antigen is going to be ready for prime time imminently, and there's a rich pipeline coming beyond that. That will open up new customers, but also we'll be a customer for that because we'll be securing our own supply chains for products down the line. Really, everything we're doing is bearing fruit in the operational side. I can't really speak highly enough of the team, of the team with its manufacturing, QC, QA, R&D, IT, facilities, and finance. Even finance, they're all doing a great job and creating a great environment for growth. That's what I would say with firm operations.
Things are going very, very well.
Excellent. Thank you very much, Ken. That's great. First half, very much delivered as we have been targeting, and we're pleased to see the build of our financial strength, the build of our operational capabilities and capacity. You will see in reviewing the disclosures associated with Q2, though, we are looking at a more challenging outlook for the second half of the year. Specifically, that's going to be weaker than we've been targeting on our sales of test ingredients and offset somewhat, but not entirely, by strength in our antigens business. We have seen specifically in the test ingredients business a real pause in our sales of certain respiratory-oriented antigen products into China.
Our distributor and other clients with whom we deal have indicated that there just was not as much spread of bacterial pneumonias in China over the 2024, 2025 Chinese New Year period, which is normally a period of many, many hundreds of millions of people traveling over that period and presents a spreading event. We provide antigens for that diagnosis, which is done immunologically in China, and there was not a great sell-through this year of those tests. Understandably, clients there are pausing their purchase of ingredients until that inventory is either sold through or expires. We are looking at a reduction in our sales to China over the second half, but we are looking and we are seeing the onboarding and acquisition of many new clients in our QAPs business.
Although that does not result in an immediate upshift in sales, it gives us very excellent visibility on the strategic wins that we have been targeting for our QAPs business. We are looking at a more challenging second half from a revenue perspective, but that is a tactical matter while we are achieving all of the strategic objectives that we are looking for as our business in acquiring major international multinational diagnostics companies and PT EQA agencies and continuing to build our more retail sales into the clinical lab period. Continued excellent prospects for our business strategically and more tactical challenges over the second half of 2025, for which, of course, we have ample treasury to withstand any headwinds and continue to move forward. All the while, of course, Kinlytic is moving forward as well.
From things looking a little too far away to perhaps grab attention fully, that is moving ever closer. We are continuing to be optimistic for a refiling of a supplement to the Biological Licensing Application, or SBLA, by our partners and ourselves in 2027 with the target of a reapproval by FDA late that year. That is most of the news that is fit to print, and happy to go into specifics. I do also have our current and recently refreshed corporate PowerPoint ready to pull up should we want to touch on any supplement, any of the information provided here. I do encourage everybody to review that on our website. I think there is some excellent materials in there.
All the time, we look to provide everything we see going on in as much of a level of candor as we can about the excellent progress that is being made, as well as some of the challenges as well. With that, happy to launch into questions, Deborah.
Sure. I've got a few audience questions. Talking about the slowdown in revenues from the Chinese market, do you expect this to normalize in the coming year, or do you expect that QAPs sales are anticipated to compensate for the shortfall long-term?
With China, we've had no evidence, and we work through a distributor in China, but we've had no evidence that this is anything geopolitical. Rather, it's just probably residual immunity from a worse year from a respiratory infection point of view, the prior year that people still had some ongoing acquired immunity to those bacteria this year. We have to balance between China perhaps snapping back very fast with a bad respiratory season in 2025-2026, or does that take longer? We do not want to be caught without inventories with those products, but we do not want to build too much either. We're threading a needle between too much and too little on that for those products and with those particular SKUs.
Understood. Then a couple of questions about the QAPs. Has the delay in the QAPs partner impacted your outlook on overall CAP sales? Do you still foresee this segment growing annually?
We do very much see this segment growing. One of the absolutely delightful and motivating things has been to attend some of the major international trade shows and scientific congresses and just see the excitement with potential major companies about the capabilities we have and what we can deliver for it. Working with such companies is absolutely delightful. We are currently acquiring and in the process of onboarding some of the largest companies in the field that have huge instrument install bases as well that need new assays, new games for that Game Boy or PlayStation installation. It is a delight to be pulled into supporting those customers. It takes a little while.
The typical workflow is the product starts with product development, and that's revenues in the tens of thousands, then into pilot lots to validate manufacturing, which moves into the hundreds of thousands, then pre-launch inventories and potentially onboarding kits to train new sites and new installations, and then finally into commercial reorders of product post-launch. That takes multiple quarters to work through that process. As we load the pipeline at the front end, our experience has been that things do come out the back end, and that involves a hundred-fold expansion in the potential revenues or the revenues from the start to the finish of that process. As we keep loading the pipeline, we see that coming, and it becomes a question more of when rather than if.
Can you provide some color on the delays with the large QAPs customer?
This quarter, we had two issues, one customer, and it's impolite to kiss and tell too much and go into details. I won't be discussing specific client names. One client moved from parallel development of multiple assays to serial development, and that has led to timing changes in their plans and revenue changes for us, at least in the short term, while we onboard other clients in the field. Keep in mind, we work with supporting multiple companies, and we're platform agnostic by and large. The other issue in this quarter is many of our proficiency testing customers, these are the agencies that provide what's called proficiency testing programs in North America or EQA, external quality assessment programs, schemes they call them in Europe. It's either PT programs or EQA schemes, depending on whether you're using North American or European terminology.
Those programs most often have three events per year. A lab's competency is challenged with a blinded package of QAPs for a particular form of testing three times per year. One of our major QAPs clients, it happened this quarter that one of their events, the shipment for one of their events did not fall within this quarter. That meant a lower QAPs number for this quarter. We'll see a resumption of QAPs numbers more in the CAD 2 million-plus range per quarter from Q3 forward.
Do you expect a bit of a rebound in the back half of the year for QAPs?
Very much. Yeah. QAPs will be fine and on track in the back half of the year. It's always a question of which new customer moves from that tens of thousands to hundreds of thousands to more process and how many quarters that takes. Sometimes customers, for example, if they're working on a respiratory assay, you've got two choices. You've either got the northern hemisphere, quote-unquote, "flu season" or the southern hemisphere "flu season" to do your studies, but you can't just pick August and expect to enroll patients to qualify a new respiratory virus panel test, for example. There's some inherent seasonality to some things like respiratory or gastrointestinal. One tends to be winter, the other tends to be summer, and some things have no seasonality or little seasonality associated with them. You don't have that timing issue there.
Got it. As you continue to expand that pipeline of devices and products in kind of your formative tens of thousands of sales, as that grows, the lumpiness should go away on the larger orders?
Absolutely. Along with customer concentration issues as well. The two come together. We have now about 10 clients each in the 100. We have several clients in the multi-million dollar range across our portfolio. We have about 20 clients that are $100,000 or more in annual revenues split between antigens, ingredients, and QAPs medical devices. As we broaden out that number of significant customers of six or seven-figure customers, the customer concentration risk comes down, as does the lumpiness in revenues quarter- by- quarter.
Got it. Taking a step back, what are the total addressable market sizes for QAPs and antigens respectively?
For antigens, we're broadening it out substantially with bringing on full recombinant antigen capabilities. We expand that addressable market by multiples. You're probably looking for native antigens. The total addressable market would be in the $50 million-$100 million range globally. With the amount we can capture being a subset of that, we've expanded that substantially with onboarding recombinant capabilities. Keeping in mind, we're not doing this on speculation, but rather Microbix will become the first customer for our recombinants that we produce, will use in our medical devices business for our QAPs, and then be able to offer those more broadly to our ingredients customers as fully validated products. That's the process we're undertaking there. That market expands, at least doubles or triples in terms of the addressable market there. In QAPs, it's an interesting question.
We probably originally overestimated the potential of that business in the laboratory space as many laboratories use patient sample pools that are internally validated rather than externally validated controls, as they should under the regulations, but are under extreme margin pressure and have to sometimes come up with creative solutions. For the proficiency and EQA business, we're certainly expanding that, and we've grown that at least fivefold over the past several years in terms of our penetration of that business. I think that certainly moves as well into the tens of millions in overall potential for the accreditation side, the proficiency and accreditation side of our business.
The test makers, which is what we've started and are now adding more and more customers, has dramatic potential for external controls used in kits of point-of-care test cartridges, is certainly an area we see tremendous potential on, as well as internal controls that we'll talk more about, I think, over the coming quarters. There are materials within the actual test cartridges of companies, is another big area we're looking at. Of course, onboarding kits for training and validating new sites and use in the clinical lab to bookend daily test runs, even if they're on large automated instruments.
A couple of questions on G&A. Was the increase in G&A part of ongoing OpEx investment? Should we expect a similar run rate going forward?
Good question. Jim, do you want to tackle that one?
Sure. Some of it definitely is. As Cameron indicated, we are certainly making further investments in research and development as well as in our sales and marketing, unless it was specific to the admin line. I guess in the admin line, there was some sort of non-recurring costs in the admin side that we incurred during the quarter that we do not anticipate going forward. So of our total OpEx in the quarter, there's probably a couple of hundred thousand dollars in there that will not be recurring, and we shouldn't see in Q3 and Q4.
Yeah. By and large, we have created deliberately the level of infrastructure to, frankly, be taken seriously and have the cutting-edge capabilities and win new business. You have to have that balanced with enough financial strength that potential international clients look at us and say, "We are a good pick as a critical sole source supplier to those customers." That is really what we have been doing and why we are running the business as we are in bringing in state-of-the-art capabilities, whether that is synthetic biology, digital PCR, bioreactors, recombinant technology, all these immense capabilities that we have onboarded while improving our financial strength along the way. I think it has been a challenging force to chart, but a lot of fun to sail that race.
Yeah. We have a lot of capabilities now in place to support growth without adding massively to the operational expenses. We have that additional capacity. In the next little while, we're going to realize a little bit of increased margins as we reduce testing portfolio or automate testing. We are really building that efficiency in the background all the while. You will not see any particular increase in operational expenses as our sales grow.
I may lean on Jim, though, just to be more into authorized fixing those broken chairs in the boardroom and perhaps even redo some of the carpets. It's getting a little embarrassing. We have clients in. We do spend all the money on the labs.
Labs are a few.
Manufacturing spaces. Yeah.
I guess similar question. This level of gross margin, as a percentage, is it sustainable going forward? It sounds like yes. I'll let you guys answer.
Jim has a bit of alchemy on overhead allocations, but I think that's a bit more teasing there. Sorry, Jim. Yes, in short, these are improvements that have been most significantly driven by progress from our MTech group on manufacturing technology engineering and some benefit from optimizing pricing and having a very clear-eyed and steely-eyed view on what our real costs are. Jim, did you want to comment further?
Yeah. I think you covered most of it off, Cameron. Yeah. I think as we go forward, that would be my expectation. I think one of the key areas where we have been held back a little bit has been in our test ingredients or antigen business, where we haven't had the yields that we had anticipated, and we were working on process improvements that have finally come to fruition. Based upon where we are today, I would expect that the margin expectation should be where they are right now.
Yeah.
We still have the, now we have the capabilities, the size, the critical mass to drive these processes to continue to boost yields and to continue to reduce unit costs. That is what we are going to have happen. Bottom line here, it is absolutely, we would expect to maintain those margins.
Yeah. I think we have the torque on revenue growth as well as Ken had indicated and Jim has indicated. We're not adding a tremendous amount from here to our footprints and infrastructure. As revenues grow, we'll see some of that, some further margin expansion, particularly as we secure longer-run commercial programs and fewer pilot product development programs for our QAPs business. That would have an upward bias on margins. Of course, we need to be allocating manufacturing costs across what revenues we generate quarter to quarter. We'll still have some lumpiness for a few quarters yet, I think, before that works its way through the system.
That's a good point, Cameron. I was just going to say that. I mean, one component of gross margin is the cost aspect, but the other is the revenues. We've certainly got the manufacturing infrastructure in place to grow our business and probably produce 50% more than we are producing today. However, if we do drop off in revenues, they're going to be absorbing the overhead in that short-term period.
Yeah.
All right. Moving on. I've got two questions left. If anyone has any, make sure to get those in before we get through these. The first question is on most favored nation policy implications. How might the recently revived most favored nation directive proposed by President Trump impact the pricing strategy or reimbursement outlook for Kinlytic in the U.S.? This policy could potentially influence reimbursement dynamics, and we're interested in understanding the company's preparedness and response. Bit of a long one, Cameron. It's the first one in the Q&A box if you need to review it.
I may do just that. I'm just going to digest that sentence here. Okay. This refers to the comments in the past few days about drug pricing in the United States and how the United States should not be priced dramatically higher than other nations in terms of the cost of drugs. We're very fortunate in what we're doing is very much rubber meets the road kind of medicine. We're talking about a drug with Kinlytic urokinase for catheter clearance where you are infusing about $150 worth of drug into a catheter to dissolve a clot and then safely remove it and avoid probably $10,000 or more of surgical costs from having to remove a long-term indwelling catheter and replace it using a vascular surgeon as the physician and often a general anesthetic and a nurse and risk of morbidity and mortality associated with that.
This is not the sort of million-dollar orphan therapy that we hear about. It is very much meat and potatoes in terms of the dollar costs being modest and the benefits being incontrovertible. I do not see this being an issue for us at all. In fact, our partners are looking at the manufacturing of this drug in the United States for the critical portion of the manufacture of the active ingredient. It will be a US product for the vast majority of its value and thus would attract no tariff regardless of the situation. The pricing is so modest compared to many therapies and the benefits so clear, I do not see it being an issue at all. Ken, is there anything you would want to expand on or correct in that?
No, I think that's fine. The urokinase program is addressing what is essentially an unmet medical need or a monopolist situation. The drive to do that is clear. To your point, Sequel and the CDMO that we're working with will be essentially a U.S.-based experience. Therefore, we don't see any problem with that going forward. Notwithstanding, it's the state of the art. It's the best product in this particular space. People want it anyway. We're moving forward, it appears to do that. I mean, I may jump in and reiterate to the group that our relationship with Sequel is excellent. They're very sophisticated in the process development, regulatory, and marketing aspects of this. We're working closely with them.
Of course, they're a portfolio company, one of the biggest life sciences VC groups in the world, who are covering the entire cost of this, including paying for my time to help them with the technical and regulatory aspects of this product. We're very, very serious in moving forward. Recently, in this milieu, Sequel has just brought on board the contract manufacturing organization for the fill initiative drug product, the labeling, the packaging, and labeling and ready for distribution as part of the program. We're moving forward, and we expect to realize all the timeline remains the same for 2027, and the opportunity remains the same going forward. The relationship with Sequel continues to be excellent.
Absolutely. Thank you, Ken. I would encourage everybody to review our news release from May 5th, which describes the latest progress. That is the second biggest contract in the and spend associated with the return of Kinlytic to market. The largest contract and spend was with the drug substance manufacturing CDMO or contract drug manufacturing organization that was announced last year. This year, this spring, we have been pleased to announce the engagement of the drug product CDMO. One is the active ingredient. The other is the finished formulated package product. Both those contracts have been undertaken. Collectively, they would have blown through our entire treasury probably times two, those agreements. It speaks to the logic of our doing this through a partnership where all costs are being funded, including the direct support, as Ken mentioned.
The relationship with both CMOs continues to be very constructive and on pace and on track.
Yeah. Thank you.
Great to hear. I've got another long one for you, Cameron. Again, it's the.
Okay. Better open it up.
This one's on your European expansion strategy. Actually, let's start with because they talk about Syner-Kinase, which as a layperson, I'm assuming is some sort of drug competitor to urokinase. Maybe we can start there. You can give us a little bit of background on Syner-Kinase if you're familiar.
I don't know that trade name specifically, but there have been what are called high molecular weight urokinases available as legacy approval drugs in Europe. There are a number of functional differences with high molecular weight kinases that make them less desirable as a therapeutic. The biggest issue is that high molecular weight urokinase is manufactured by isolating the molecule from vast quantities of urine collected typically from soldiers or prisoners. That process is typically run in India or China, where there are large population centers of such individuals. Regardless of how good your filtering or viral inactivation processes may be, there's always an immense risk of a process failure or a catastrophic risk, however small, of process failure exposing treated individuals with potentially the risk of 50,000 or 100,000 individuals' health records.
Those sorts of products, while they have legacy approval in some markets, would never get approval in the United States or approval at the EU level, even if they're available as legacy items in some markets. That's sort of the difference. Our process is cell culture derived from a single tissue donation. The risk is completely inverted. Whereas 50,000 people might be contributing urine to a pool and then that be treated with thousands of people, we're looking at one donation that would be heavily screened as well as all state-of-the-art viral inactivation and filtering procedures being conducted from a clean donation versus donations that inherently cannot be clean and relying on that. Just a bit chalk and cheese, if I can use the term in terms of the comparability.
Maybe just to supplement that, Syner-Kinase is indeed a high molecular weight form of urokinase, which is from thousands of liters of donated urine with all the issues that Cameron described there. High molecular weight urokinase has been used in Europe and in Asia for a long time. It has never been approved in the U.S. for the very reasons Cameron already said about the safety and the origin of the materials. There is another aspect of this. The urokinase that comes out of the urine is high molecular weight form, which has growth factor domains and different biodistribution capabilities, which can potentially influence health outcomes. That is the reason why tissue plasminogen activator is totally dominated in that market as well. It is not a good alternative.
We should not be confusing high molecular weight urokinase with Kinlytic, which is the low molecular weight form, which does not have all those receptor binding domains that cause differential biodistribution. It is produced with a biotechnology process with all the necessary bells and whistles and testing that goes with that. I would also point out, even though the presence of Syner-Kinase in Europe, TPA still has more or less a monopoly. The European regulators actually reached out to Microbix to remind us not to forget them with our product when we bring it back online after we have dealt with the FDA and the U.S. market. Clearly, this is a superior product. They do not have the advantages we do. They also do not have the advantages we have over TPA, which is the stability of urokinase at room temperature. TPA is stored in the fridge.
That is a very big operational advantage for urokinase going forward. I would not be concerned by the presence of a high molecular weight urokinase form whatsoever. It will not take over the TPA market. We will be a functional biosimilar to TPA when we come on the market and an actual bio better.
Yeah. Great points, Ken. Thank you so much. Just dealing with the second part of that question, how does that expand? How do we expand that market? Initially, we'll be looking at clearance of blocked catheters in the United States. Then we will be looking at likely catheter prophylaxis, so clearing of biofilms out of catheters that aren't yet blocked to reduce the risk of blockage or infection. We'll then, in parallel, be looking at expanding the geographies for the catheter clearance indication. We'll, in parallel, be doing some, I hope, redevelopment of the upstream manufacturing processes to enhance efficiencies. Once we have indeed a product to compare with, we can more readily validate new processes.
That is the path to reopening the systemic indications, the many systemic indications for our low molecular weight urokinase Kinlytic for things like pulmonary embolism and other systemic clots like stroke, heart attack, peripheral arterial occlusions, deep vein thrombosis, and so forth.
Okay. I think just in providing some background on Syner-Kinase, you mostly answered this question, but just so that I'm thorough, I'm going to pose it. If there's anything else you would like to add, feel free. The question was, it is our understanding that Syner-Kinase is currently available in four European countries and holds approval across all four major indications, a milestone that Kinlytic may be sometime away from reaching. Is there any concern that Syner-Kinase has not expanded to more EU countries because the demand may not be sufficiently strong? I think you've covered that it's not a demand issue, but maybe a product issue.
No, I think it's very much a product issue. Anytime you're looking at a product that's pooled from many individuals that may inherently have a risk of having infectious human pathogens in the sample or tissue they're donating, it has enough risk to make regulators pause. I think expanding the number of countries and the number of approvals and indications will be a challenge. It will be even more of a challenge when Kinlytic comes back into those markets. You say, if we can supply something that's superior from a functionality point of view, as Ken indicated, and has lower associated inherent risks, it becomes a question of what is the role for Syner-Kinase going forward much more than it is a question about what's the role for Kinlytic.
Yeah. Syner-Kinase is an inferior product to tissue plasminogen activator and that describes why it hasn't taken off. Kinlytic is not an inferior product to tissue plasminogen activator, the current market effective monopoly. It's a better product. Therefore, if you look at where TPA sells, you'll understand where Kinlytic is going to sell.
I think that answers the question sufficiently. Moving on to some other more general questions. Can you provide information regarding the development going on for European customers? What kind of revenue are you expecting from the different regions you operate? I'm assuming that they mean for all products.
Okay. Yeah. I'll say the typical example. On the 13th of May, we announced a program with Aurevia for support of labs doing molecular diagnosis of bacterial vaginosis, which is a condition of an imbalance between healthy and potentially pathogenic bacteria. Such a program initially starts as a pilot program, and that might involve 50-100 labs where that's piloted out to see how the Microbix QAPs perform on all the different instrument platforms and help provide that validation. Typically, that will involve, in this case, three samples, three events, 50-100 labs piloted. As data is gathered and any necessary troubleshooting is done, that program might expand 5-10-20-fold next year in terms of the number of labs and become a regular product offering for that agency customer and an annuity for Microbix.
What we're doing is building and layering on these annuities. Another example would be the H5N1 work with American Proficiency Institute. Again, started with multiple pilot events to look at that. That will become a regular product offering into likely thousands of labs in subsequent years, 2025 forward, as labs need to continually revalidate that, yes, we can find H5N1 if it occurred. Again, another layering on of an annuity. Other developments that we look at anytime we're baked into the regulatory file of an assay, and that could be a laboratory-based assay or a point of care assay, those reorders, again, become recurring business to us. There are a few things that are less predictable. For example, our onboard kits where those are for training new installations and new assays. That just depends on the ongoing market penetration growth of customers as well.
There are many layers to our business, and we continue to grow them. Europe remains an important market for us. It has fluctuated between about 40% of our sales and probably in the 25-30% range, depending on what has gone on in other markets. It remains a significant portion of our business.
Okay. That was 35% through the first half of the year, Europe.
Thank you, Jim. I didn't have that number in my head, but that's absolutely wonderful to get it. Appreciate that.
Staying on percentage of sales, we have our last question, which is, what percentage of antigen sales are in China?
We grew that into a significant portion of the business across two categories, respiratory and prenatal test screening. The portion of antigen sales overall became quite significant last year and has been significant in the first half as well. We were north of 40% in terms of sales into Asia for the ingredients business last year for the antigen business. It was significant over the first half as well.
All right. I do not see any additional questions, but somebody always sneaks one in at the end, so we will give them a minute.
Okay.
Cameron, Jim, Ken, thanks for taking the time to review the quarterly results and outlook for the rest of the year. I think that's been really helpful. Is there anything that you wanted to discuss today that we didn't cover or any last thoughts you wanted to leave the audience?
Yeah. I think certainly our strategic gains are continuing to come. We're going to see those come, I think, fast and furious. Just looking at the disclosures we've made of new programs and customer onboardings since January is quite significant. We don't see that pace slowing down at all. Strategically, we're very much executing. I think what we have is the simple market ebb and flow coming out of Asia on disease incidents. That's going to bite us a little bit in the second half. We have tremendous financial strength, so we have no issues with that tactical matter disrupting anything strategic that we're pursuing and continuing to execute on. Great strength in the diagnostics-oriented side of our business and excellent ongoing progress there, coupled to tremendous balance sheet strength. All the while, we're winding forward on Kinlytic to drive that forward.
A healthy diagnostics business growing and providing leadership and acquiring customers left, right, and center and adding programs coupled to the successful development of a drug asset and without the normal binary balance sheet risk that we see with such companies. Again, Microbix operationally excellent, strategically in place, and immense financial strength.
I think it's interesting that you said it. Sorry. Go ahead.
No, I was just going to ask if Jim or Ken wanted to add any thoughts.
I would just support that position. I think we're in an operationally excellent position. We're continuing to build yields, add product offerings, reduce costs per product offering by implementing things like the electronic quality management system and ERP. Everything's on course as it should be. We've executed, as we said, we would. All the labs are there. I can't speak highly enough of the teams from all the different departments. We have a fantastic group at Microbix. It's not just us three sitting here. We have a huge team behind, not a huge team, but a very strong team behind us driving us forward. That capacity building and that capability building is setting us in a great stead to go forward. Basically, just to support what you said, Cameron, I think that's absolutely right.
Great. Thank you, Ken. Jim, any parting words?
No, I think you two gentlemen have covered everything up pretty well. No, nothing incremental.
Okay. All right. Deb, any questions, further questions you might have?
No, I was just going to comment that Kinlytic is something that we've discussed for a long time. It's always seemed long-dated. As you point out, 2027 is not that far away. As I've watched a lot of companies report Q1 over the last couple of weeks, you've seen analysts start to roll out their 2027 estimates. You're a quarter ahead, right? I would assume that you're going to start to see 2027 estimates being put out there in the market. I mean, it's 18, whatever, 18-24 months away still, but it's going to creep up pretty fast. I think it'll start to materially impact how people are evaluating Microbix, or it should within the next year. I think that's a strong positive for the stock.
Not to harp on the past at all, but I have worked with you for a long time, Cameron. I've seen you lose revenue lines before and quickly replace them. I think that's one of the really efficient skill sets that the Microbix team has is the ability to backfill products and backfill revenue and figure out new product lines. Like you always talk about, you build a platform for growth. Now you just have to go and find some of that growth for the back half of the year and for next year. I have full confidence you've done it before. You'll do it again. For anyone new to the story, I would say the coming quarters is probably going to be a really good buying opportunity.
Yeah. I think this is it. We've got to run. We obviously disclose what we see when we see it, and we'll continue to be completely forthright. I just remind everybody, when we do disclose programs, these aren't things we just conceived and threw out there. These are things that are now fully baked. That's the trigger for our disclosure. When you see a new program coming out, we're announcing it because it's done. We continue on that pathway.
Speaking to the best way to speaking to the timeline and the risk on Kinlytic that you mentioned as well. Yes, the timeline is short, and it's still talking 2027, as we said all along. As I say pretty much every time, I'm going to say again, this product is not new. It's already approved. We're putting new manufacturing in place. There are decades of clinical experience for this product. This is a new biologic production system, but not a new biologic per se. That's why I'll state directly, there is zero chance of clinical failure of this product. This is purely a manufacturing site transfer. That's why the timelines are short, and that's why the risks are low.
Yeah. Still expensive. It's a big boy game, biologic drug manufacturer. And why we partnered this? Yeah. Yeah.
New entities at entry phase one, less than 10% exit phase three successfully. There's no chance of that happening with Kinlytic.
Exactly.
Okay. We are ending pretty much right on the hour. Thank you, gentlemen, for your time. Thanks to the audience for your questions, your participation. I hope everyone has a really nice afternoon.
Thank you. Thank you, Deborah. Thank you, Jim and Ken, and everybody. Really appreciate it.
Take care.
Take care. Bye.
Good morning, everyone. Thanks this afternoon.
Everybody, really appreciate.