Microbix Biosystems Inc.

Microbix Biosystems Inc.

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Biotechnology

Microbix Biosystems Inc. (MBX.TO) Q4 2021 Earnings Call Transcript

Published at 2022-01-04 17:29:06
Deborah Honig
Good morning. Thanks for joining us today. We have a webinar with Microbix, who put out their Q4 numbers on December 23rd, I believe, and also had some material result - news of the day after about VTM sales to Ontario. So an exciting year end for the company. With me today I have CEO, Cameron Groome, who I'm sure most of you know, also we have CFO, Jim Currie and COO, Ken Hughes. For those who might be less familiar with those characters. The format of the webinar will be a run through of some of the high level points of the quarter. And then what will probably be a lengthy Q&A session as it usually is. As always, this presentation will contain forward-looking statements. If you'd like to know more about those you can find them on the company's presentation on their website. And as I mentioned, there will be a Q&A section so feel free to put your questions in the Q&A box at the bottom. With that out of the way, I'd like to introduce Cameron, Ken and Jim. Hi, gentlemen.
Cameron Groome
Hello, Deborah, thank you very much. And thank you, everybody, for joining us. I see we've got a good crew and appreciate everybody taking their time this morning - this morning, we'll do our best to make it worthwhile. Deborah, I thought we'd run through a little bit about 2021 results, speak a bit about why those results were achieved. Give some big picture items in terms of the outlook for the company. And then we'll conclude with a bit of a summary on what we see on a going forward basis. Just very briefly, for those who don't know our company well. Microbix is active in a number of areas. I'll just quickly share screen on one slide from our corporate presentation, just describing the company and you know where we are with Microbix, we develop, make and sell biological products and technologies from our base in Mississauga, Ontario all over the world. And we have three principal revenue generating segments. Our diagnostic quality assessment products or QAPs. These are the controls that help ensure the accuracy of a wide range of medical tests including PCR and antigen tests for COVID. But much more broadly than that, we are also have become a core producer of viral transport medium for PCR and other testing for Ontario, and are moving forward with material production and sales of that. And the core business from which we started, our supply of native antigens as critical test ingredients and these operations are what have generated growth to prime us for continuing growth as we expand our production, optimize our production methods, optimize margins, and drive share price appreciation. And there's considerable information about the company on our website, on our public filings. We are listed on the TSX and trade on the OTC QX market in the United States. So talking about 2021, we've accomplished a great deal across the fiscal 2021 ended September 30. And that includes growing sales by over $8 million and close to 80% year-over-year increase, so quite an achievement. We also improved our percentage gross margin by 15% year-over-year and over $6 million of incremental gross margin, which realized strongly positive net earnings for each quarter and in fact for the full fiscal year. In the process, we also massively strengthened our balance sheet and financial position to a much stronger position, a combination of earnings and cash flow and also an equity offering, public offering and concurrent private placement, as well as the exercise of warrants from prior financings. We demonstrated very much successful growth in our quality assessment products, our test controls business increased top line over 200% year-over-year for that very important growth segment. And we launched a third revenue generating unit with our Viral Transport Medium sales, branded DxTM to Ontario and others generating $4.5 million in sales of that entirely new business area for us, so a resounding success there. And, you know, I have to highlight in speaking about this, that this is a result of a lot of planning, and efforts that go back several years. And it's the corporate expertise that was built over decades, that enabled us to build on the - the specific skill sets at the company to drive success. And we've not just done that, in random, we had specific targets for 2021. And that extends into 2022, as well. So I think now, with the 2021 results, and the reorder from Ontario, that was announced on December 24th, for our Viral Transport Medium really puts to bed any, at least to rest any concerns about whether there be orders and whether that is an ongoing business for us. We also would say that our quality assessment products or QAPs prospects there have never been brighter as we move forward, particularly with different OEM discussions for supplying QAPs with different companies test cartridges [Indiscernible] and our antigen sales very much stable at margins that we've been working to improve across years, and as those recover will drive, we believe more gross margin dollars out of every dollar - more gross margin pennies out of every dollar of sales. So we should see some very strong fiscal 2022 results. And of course, we’re well into the fiscal year now having a September 30 year end, so our fiscal 2022 started on October 1st, and our first quarter of the fiscal year ended on December 31st. So some of the things that I most want to communicate today is, you know, how we're preparing Microbix to be the leader in its areas and also support a much larger scale of business. You know, during COVID, and afterwards, we'll have a much greater emphasis we believe in worldwide health systems on bio-vigilance, and that bio-vigilance is going to be driven by widespread and sophisticated diagnostic testing. And I've referred in prior webinars to this likely being the golden age for diagnostics industry. And, you know, we are broadly supporting it. So we're not one company with one platform trying to gain commercial success at the expense of others. We're very broadly supporting industry in multiple areas, and see Microbix benefiting from those broad trends. And those areas that will benefit and specifically that testing is going to require supplies, and like VTM, and above all test controls to ensure the accuracy because the only thing worse than no testing is inaccurate testing. And it's our products that help ensure that the testing doesn't result in false negatives, or false positives. So we're incredibly well positioned, we believe to benefit from the broad trends not just during COVID, but as COVID goes from pandemic to endemic. So it's to support such growth. And I'm talking when I talk about growth, I'm talking about a large percentage sales increases each year, that we have to have both capacity and systems to support and enable that growth. And that's what we're setting up to take the company from where it is today to more on the order of $100 million top line. And that growth entails QAPs, supporting QAPs, supporting viral transport medium and having systems such as electronic quality management systems, enterprise resource planning systems, LIMS systems, for that kind of scale, and that's what we're gearing up to be able to properly support that growth. We actually make stuff you know, and you've invested in a company - very real competence and increasingly successful. That is making critical products here in Ontario for the world and we're building on the 35 years of virology and diagnostic expertise, great conductivity across the whole diagnostics industry. We now up to 100 staff across three facilities. We have the capability to manufacture at over 100 SKUs now in our commercial scale. With pending automation, we've got all the QC and QA capabilities, required registrations and licenses to make these critical products. We've got not only our own direct sales capabilities, but we also have global distribution network in place now with nine distributors. We've got a strong balance sheet. We've got a growing market cap and the TSX listing at US trading. And we've got I would maintain sophisticated management that is seriously running the business and is very much shareholder value-driven. So you know, this is what I want to drive home today. And from there, you know, I certainly, Ken, and Jim can supplement those comments as we get into the question side of things. But I think 2021 has been a very strong year for us. 2022 is setting up to be even stronger. And we're creating all of the systems needed to sustain profitable growth for our company that will be meaningfully beneficial to all of us as shareholders, and we all are meaningful shareholders. So that's the sum of my comments and love to take some questions at this point. Q - Deborah Honig: Thank you, Cameron. So the first question that we have from the audience is about Kinlytic, would you be able to provide an update on how that's transpiring?
Cameron Groome
Yes, we remain certainly hopeful that we will secure a partnership for Kinlytic. We have terms that we have discussed that we believe would be quite acceptable to Microbix, as well as beneficial - jointly beneficial to a prospective partner. And we are looking forward to move to a definitive agreement on Kinlytic and you know that and, and five bucks might get you a cup of coffee. But until an agreement is signed, but we are optimistic, and that is still an active file.
Deborah Honig
Okay, thank you. And can you please explain where you're at in your capacity expansion?
Cameron Groome
Certainly, there are two expansions ongoing. One is in relation to our quality assessment products. And that's taking place at our site number 2 at 235 Watline Avenue, Mississauga. And the second that is underway is at 275 Watline, our third site in relation to Viral Transport Medium our DxTM product line. And Ken maybe I can ask you to - to dive in with some comments on how that's – how that's been proceeding through 2021 and how it's unfolding into 2022?
Ken Hughes
Well, absolutely. And at the start of 2021, and actually, in 2020, we raised some money through FedDev Ontario, and the group is probably well aware of the Ontario Together Fund grant that we received in support of the activities we're doing regards to VTM, and the QAPs. And so in that period of time, not only have we been building the capacity in semi-automation and staffing up and building up facilities, you know, the group is probably well aware that we've activated some new laboratories, now second facility in 2021, is another laboratory and just being built is being commissioned in our second facility. And we've acquired the third facility, where an automation suite for VTM DxTM production will be in place in the spring. So throughout the time, we've been building that capacity, and that will continue. So we will now have had have three new laboratories online now, fourth in the spring, and the automation for producing swabs [Indiscernible] and DxTM at much higher scale going from say 60 to 100,000 a week to 60,000 a day. And therefore build - building our footprint and beyond that actually is ongoing right now and will continue in that capacity building situation. Also to Cameron's point, automating our systems, the digitization of our quality management system and all of those processes that allow us to manage our growth is being put in place. We just hired a Director of IT for instance to - and his group will be solidifying that capability. we have some capability already, but as well in this kind of meteoric growth phase, we want to make sure that we're not weighing down the rocket, as it were, as we move forward. So everything is designed to support rapid growth. It's exemplified by what we've done in 2021. And we consider that it will - it will continue in 2022.
Deborah Honig
Thank you, Ken. Can you comment on the updated eligibility for PCR testing in Ontario that was announced a few days ago? Is this expected to significantly decrease the number of daily tests and thus the demand for VTM?
Cameron Groome
I think it's – I certainly invite Ken also weigh in Deborah, but I think it's more a question of test capacity was - was more than maxed out. And these changes are not going to reduce testing volumes, but rather, perhaps, permit the system to keep up. Ken, what are your observations?
Ken Hughes
I completely agree. And, you know, obviously, this system is just bombed by the number of cases that are going right now, as we move through omicron, and we get back into this kind of endemic reality, there's still going to be a whole lot of testing going on. And don't forget, again, the golden age of diagnostics is not just COVID out there, as flu or various [Indiscernible] viruses, human papilloma virus and, and non-viral related testing is going to be going on which is going to require transport medium and PCR based testing. So in terms of growth in our business and support of that in Ontario, and subsequently in Canada, and then perhaps throughout the world, there's lots of opportunity there. And certainly it's not going to be an impediment to our growth.
Deborah Honig
Can you maybe give an update on VTM orders outside of Ontario? Is that something that you're still looking at expanding outside of Ontario?
Cameron Groome
Most, certainly we are. And you know, it's a bit, you know, we occasionally share some frustration of shareholders on visibility order flow. However, it's very good that we effectively moved out all of our inventory of VTM has been provided to the province. And I think everyone is thankful that we built inventory, or it might have been a very difficult situation all around, had that not been the case. So we're in full swing production. And I, I suspect that we will fill orders as soon as ship product as soon as it becomes available.
Ken Hughes
Our communications consider other provinces throughout Canada, but right now, Ontario's taking everything we've got, and it will take more if we could make it faster. And that's why we're ramping up.
Deborah Honig
Okay. And then I had a question, which is somewhat of a follow-on question. I've lost it, sorry. There's a bunch coming in. Let's back up a little bit. Still talking about the VTM automation, what's the timeline to 100 million in revenue business?
Cameron Groome
Well, I think I think we can - we can talk about capacity, I would be reluctant to - to talk precisely about, you know, whether every high order capacity is used, but we are - we have demonstrated our capabilities to produce quite readily 50,000 vials per week. We had - we did run, a number of - we double shifted at 100,000 vials per week. That is full tilt, however - excuse me. That is full tilt however. What we're looking at is automating such that we should be able to produce on a single shift more on the order of 50,000 units a day or perhaps double shifting, that could be up to 100,000 units a day. So that is the sort of automation equipment that we're procuring, and that will arrive in Q1, the calendar Q1, the quarter that we're in, and we'll have to see exactly when the qualification procedures are completed to put that into use, but all of that is furiously ongoing now. Ken, did you - did want to add to that at all?
Ken Hughes
No, that's exactly right. And that's the timeline. The team has done a superb job in the semi manual, semi automated scale up to meet demand that's currently in place but you know, to go outside of Ontario and beyond, and, you know, take a bigger share of Ontario, we're going to have to automate it and we've already ordered the equipment, we're setting up the qualification technologies, got the team in place, we're building out the facility in our third building right now. And so in the spring, we should be good to go and - and move on from there.
Deborah Honig
And how much for these expansions cost? And will you be able to complete them with your current and generated cash?
Ken Hughes
Yes, I'm going to answer that, Jim, why don't perhaps you can jump in and talk a little bit about the costs associated with that expansion. Thanks.
Jim Currie
Sure. Let me first start by thanking those that are on the call today, many of you are shareholders of ours who have been shareholders for a long period of time and through some of the pilot private placements and public offering you provide us with the funding that we needed to grow the business. And we've just discussed a few examples of what we've been using those funds for. One was we were able to build inventory of VTM. Without an order in place, which was very excellent timing for the province, I'm sure they're very happy with the fact that we had built that inventory. And also, it's allowing us to make these investments in automation, and also the facilities that we've got going on right now. So our we've got budgeted, and we had as part of our public offering use of funds, the - these items as investment opportunity items, and we'll be spending - we will have spent, probably somewhere in the neighborhood of about $300,000 on improving the facilities and one of our locations and building lab capabilities. Our new facility will likely be spending in the neighborhood of a $0.5 million in that particular facility on getting it ready for a lab, as well as expanding our office capabilities. In addition, we're also making investments in the automation, and that automation will - which is started and we will spend about a $1 million in the first six months. And we've got continued plans for additional automation in fiscal 22 later on as well.
Cameron Groome
And fair to say that those projects are all funded from the capital that we have on hand.
Jim Currie
Yeah, sorry, I should have said that.
Cameron Groome
Yeah, yeah.
Deborah Honig
It's currently producing VTM? Or is it paused for expansion?
Cameron Groome
It was paused for expansion, and is now back in production.
Jim Currie
Now, the [indiscernible] our second facility is now in full swing making VTM in support of the Government of Ontario right now. And obviously, in the communications elsewhere, the third facility will have - well, how's the fully automated line in the spring?.
Deborah Honig
And what's your first production run rate?
Cameron Groome
We are currently producing on a single shift at 50,000 files per week.
Ken Hughes
Can there - have you spoken with Damien and team about potentially doubling that up again? Or…
Jim Currie
Indeed I have. And we're doing exactly that.
Cameron Groome
Very good. Yeah. I didn't really need to speak to DME. He was already on it, as usual.
Jim Currie
It's good, good.
Deborah Honig
And I have a couple questions related to VTM generally, if you could clarify. Is your VTM, specific to COVID? And if so, what's the plan to expand its use, maybe you could talk a little bit about the universality of VTM?
Cameron Groome
Sure, our VTM is characterized for any viral testing currently, and can be used for that broad purpose. There are different kinds of transport medium for different kinds of testing, for example, if you want to read culture bacteria, or recovered live virus, so those are different nuanced formulations of VTM, that certainly were capable of producing, the one that we manufactured was specifically as requested by public health authorities. And that's why we made this specific type and it's been very positively received by - I think, pretty much everyone who's - who's used it is what can maybe you can expand on that feedback.
Ken Hughes
Yeah, we've had lots of feedback from the end user about the – not on the utility and the quality and consistency of our materials. And you know, as we talked about earlier, we're very serious about quality and scale up with Microbix and that's manifested in the customer satisfaction feedback we get from the end user. Yeah, our current DxTM is indeed a viral transport medium, not just the COVID transport medium. So any viral load can be pulled out for PCR testing. If you want to outgrow materials for COVID [ph] testing that's a different formulation and there's also a full inactivating formulations, and part of our development effort is to add to the menu of transport mediums. But current DxTM is a fully viral transport medium and not just focused on COVID. It would work for flu and RSV, and other things that you've probably heard about in the last little while.
Deborah Honig
Okay, I'm just looking, I don't think that there's anything else in the chat on VTM. So Oh, yes, there's one more? Are you looking to secure a long term guaranteed minimum contract for VTM in Ontario, et cetera, to secure long term visibility?
Cameron Groome
Certainly we are. And I think, you know, our relationship is been very good with the province. And we're encouraging them to look out longer than just order by order, in order that, that we can provide the continuity. And it isn't just, you know, lining up the fact that that we built inventory risk that perhaps was preventing some difficult situations for Ontarians. So we very much want that long term relationship where we plan together for inventories and can become more intimately involved in even in their projections, because certainly, we have a very broad overview of what's going on in the industry generally, and can add value at the table. So yes, very much on our radar, and to do that provincially, with Ontario with other provinces, and indeed federally as well.
Deborah Honig
Okay. And are you looking at any acquisitions in complementary or new business lines?
Cameron Groome
We do consider them, until relatively recently, our market capitalization has not made it overly appealing to and valuation is not made to be overly appealing. And we're still looking at a pretty low forward multiple on our shares. So it's an expensive currency we'll be using. We do have some cash, there are opportunities that we see from a sales channel point of view from a complementary product line point of view, and even from the supplier integration point of view that we could look at. The considerations are, of course, do you rent, do you build? Or do you buy anytime you're looking at an acquisition, just you don't want to make acquisitions just for the sake of being seen to be doing something. So they have to be at the right price, they have to be the right fit. And we also have to make sure that our management team has incremental bandwidth that we can successfully integrate in the acquisition, and we'd look at things through that very broad lens. And - but we do how we do - we continue to have a strong balance sheet and are in a good position from both a cash point of view and an equity point of view. If we see the right opportunity, will - we have some good capability to act on that. Jim, have you have you spent all the money on the balance sheet yet? Or do we still have a little bit to hang well?
Jim Currie
Oh, yeah, we still have a little hang around. Ken hasn't spent it on here.
Cameron Groome
Yeah.
Ken Hughes
I want to deploy it properly.
Deborah Honig
And when the automation is complete, do you - are you getting to any sort of like gross or EBITDA margin forecast? What sort of, like…
Cameron Groome
Yeah, we're not guiding, specifically by product and by product line. But we are guiding toward - we are targeting, you know, to see corporately a better than 60% gross margin. And certainly, we'd like to see new products introduced to be better than that margin to bias it upwards, not downwards. So you know, we came in for fiscal 2021 at a 59% gross margin. And that was up from 44%, the year prior. And Jim, I'm not sure I have it in my head as to what our fiscal 2019 margin was, but certainly the gross margin - but certainly where we're pushing to see margins in the 60s.
Deborah Honig
Okay. And you referenced potential VTM demand from other regions, are you actually starting to see that demand from provinces or other countries from around the world?
Cameron Groome
Well, you know, the - there's a bit of, I think, moving as a pack, in terms of the projections and you know, many people were thinking perhaps they could take a wait and see attitude with regards to procurement supply. And that's- that's certainly proven to be a dangerous strategy. So anyone that was thinking of buying product from us, is now going to have to get in line. So we will be moving forward. We have made some commercial sales, we have made some sales to into other provinces. But for now, as we're dancing with the one that Brungus [ph] and with Ontario providing a significant grant funding, and fed out of provincially and defensive interior program, from the federal side, a geared towards Ontario is our first loyalty necessarily has to be to Ontario and Ontario. So I think that that will broaden that said that will broaden out quite dramatically in the next few months, as our automation capacity comes online. The extent to which we have any supply surplus to the needs of material, we'll be delighted, of course, to to provide that more broadly. And, you know, we're looking at, of course, the larger Canadian provinces, we're looking at the smaller Canadian provinces, and we're looking at procurement at the federal level as well.
Deborah Honig
I think that covers all the questions about VTM. So let's move on to QAPs [ph] So I believe you mentioned in your introduction, you're now supplying QAPs to OEMs in defined quantity with their test cartridges, how many OEMs? Can you provide any guidance as to the magnitude of this recurring business?
Cameron Groome
We are these are - these are the discussions we're now working to conclude. And as they come to the fore, what we want to see happening is that our QAPs will be included with a positive swap based control, for example, in every kit of 25 to 50 cartridges such that it's predictable in recurring revenue stream business, and the capabilities that we've demonstrated whether it's with the original COVID Bouman [ph] strain, whether it's with variants of concern that we've generated, and the multiplex control that we announced on December 20, these are all demonstrated capabilities, and that OEM segment of our business, we believe, will become a large driver of growth in 2022 and beyond 2022. So those are matters that are concluding. And in real time, and that we're working on now/
Deborah Honig
Can you quantify what a large driver of growth would be?
Cameron Groome
Well, you know, depending on the size of the company, we could be looking at anywhere from, you know, 10,000 units a month per customer, up into hundreds of 1000s of units per month. And, you know, typically those are in the in 10s of dollars per unit in terms of the cost, or in terms of the sales price from record books. So these are these are, you know, large numbers that we're talking.
Deborah Honig
No longer those discussions, would you expect to see some of those deals signed in the coming quarters?
Cameron Groome
Yes.
Deborah Honig
Okay. And then you mentioned the multiplex QAPs that you announced on December 20 [ph] are you currently selling those?
Cameron Groome
We are now - we have the sold some of those to procurement, this proficiency testing organizations in we're now gearing those for sales to OEMs, as well as to clinical labs. So the announcement we made is for the fully IVD version, our red flock skews. And those are available now for labs. So any labs running a multiplex instrument, an instrument that's testing for multiple viruses, multiple respiratory viruses, those four specifically, can now instead of having to stock for controls, to run them at intervals, can use one single control and know that each one of their test channels or tests that they're running concurrently is actually working. So this is the efficiency and cost saving and the real innovation on our part.
Deborah Honig
[indiscernible] test for different variants as well?
Cameron Groome
Yes, we could creating multiplex that covered off different variants also, thus far, that's not been a driver for us. But we could also - we could readily create such a product – Ken, what would be your thoughts.
Ken Hughes
Just to agree and the capabilities in the lab, the research team and the manufacturing implementation team is such that we could readily do multiplex variant control, right now, people are asking for different viruses on controls, o and we can do that as well, because we grow them all, as I think everybody watching as well aware. So we have that kind of ability to respond to the Ask in real time and do it very quickly. With our quality management system in line, we can do these things in a matter of weeks, if the opportunity presents itself. And I think we've already alluded to our activities in omicron, by way, of example. Yeah, we were pretty responsive to the realities of the day, given the technology we have in house.
Cameron Groome
And from a technical perspective, the question with variance is, was there a mutation in the area of the viral genome that your PCR test was using? So the PCR tests look at a genetic segment or segments of the virus. And if those segments have mutated, then the test functionality is degraded. And that's really what you want to know. So as the virus continues to drift, you have to look and say was, you know, was the test if your test manufacturer clinical lab was it was the test that I'm making, or the test that I'm using, affected by these mutations? And what we're providing is a good way of checking.
Deborah Honig
I have a question, When should you get a dog, Kevin?
Ken Hughes
I did not. That is the question. You can ask me does your dog bite? And I can say that's not my dog.
Deborah Honig
All right. So I have a couple more questions just about the testing. So maybe we can back it up a little bit for some of the people on the call that are newer to Microbix and QAPs. Can you elaborate about false positives and how Microbix eliminates false positives and false negatives. Right now, false positives with rapid tests are widely talked about. So maybe you can just talk a little bit about the functionality of your QAPs?
Cameron Groome
Well, there's two broad test technologies that we're talking about here. One is the PCR testing, and one is the antigen test. And the PCR testing is looking for the genetic sequences of the viral RNA. Whereas the antigen tests are looking for the surface proteins on the virus or core proteins within the virus, and detecting those, the rapid tests have a bigger issue likely with false negatives, than false positives, it's thought they're probably only capable of detecting around two thirds of positives through the whole sequence of infection through to through to becoming symptomatic. They're very accurate when you're symptomatic, but less so in pre symptomatic phases. The PCR tests, very exquisitely accurate, but if it's pushed too far, it can result in false positives if there are too many cycles of amplification that are conducted. But any of these can be affected by systemic errors. And that's what the controls are most about catching. They're not enhancing the accuracy of the test, per se. They're catching errors that can be driven by technicians, they're performing steps wrongly or in the wrong order, reagents that spoiled are being used in the wrong way or instruments that have gone out of calibration or perhaps an electrode is corroded or a channel of fluid is gummed up. These are where systemic errors can happen. And that's what you want to catch is the 1000s and 10s of 1000s of errors that can result from one of these systemic problems. And that's what we're about catching. Ken, did you want to do you want to supplement that?
Ken Hughes
Yeah, we've seen situations where there's been a whole portfolio a whole load of false negatives coming out of labs where they've had systemic problems, and we described capsules, workflow controls, which covers all aspects of that. When you're getting a patient specimen, when you're testing and you're asking the question all the positive or the negative then of course an error can be made. When you run controls, we know when they're validated, they are positive, or they are negative. And you must get that result to show that your whole system is working. And our capsule look like patient specimens and not just a little bit of nucleotide, it look like something that came out of somebody's nose. And they're on swabs. And so you run it through the whole system, and you know, they're validated as positive. o you must get that result, if you get that result. And you should, and you know, that your whole system is working, you have much better confidence that what you're doing throughout the system is working for all the patients specimens. That's really what the control does. It doesn't enhance the accuracy of any individual test, it just makes sure it works at all. And that's where we've seen major problems, particularly with false negatives.
Cameron Groome
Yeah. And what would you really want is to be book ending, a run of tests with the known positive and known negative Microbix controls the start of the day or the start of the shift, for example, then end the day with a known positive and unknown negative. And it's only if you know, our positive control shows positive and our negative controls shows negative that you can start the day's work. And it's only at the end of the day, or the end of the shift when the positive is positive, and the negative is negative, that you can have confidence that everything happened that happened the middle was actually functioning properly. And if anything untoward happens at the front end and the back end, you know, either side of that book and you say, wait a minute, stop, we have a problem. It can be identified and caught immediately. And, you know, what you don't want is the catastrophe such as happened in the UK, where a lab went, you know, some long period of time without catching a systemic error and told somewhere between 40 and 50,000 individuals, no, you don't have COVID, you know, perhaps, you know, perhaps you don't have anything at all, and sent them back to work back to visit relatives who might be, you know, exposing people that are at risk of grave harm.
Deborah Honig
How often do they run the tests on the equipment? Is there a standardized, like, every 50 tests?
Cameron Groome
This is - sometimes it's a manufacturer's guidelines, for example, with the OEMs in the discussions we're having they say, every 50th cartridge, for example, you will spend that 50th cartridge to make sure the machine is still working properly, and that everything's functioning well. In the lab laboratory setting, the regulations are you must use third party controls as a part of your quality system. But it does not say how often you need to use them. And this is something you know we're going to get involved in from an industry point of view is saying let's set some standards because we've seen very diligent proprietary directors that use controls very regularly. Sure, that quality control, and we've seen other people that are very cavalier, and frankly, that's frightening.
Deborah Honig
Do you provide any of the inputs to the at home rapid tests?
Cameron Groome
The at home testing is a different scenario whereby somebody is getting a single kit. So we do provide inputs for at home testing in our viral transport medium. So for example, if there's anybody with school aged children on the call, who may have gotten a add home PCR collection kit or collection kit at home, have a look. And you may be pleased and pleased to see there's a tube of microbe DxTM in that collection kit. Controls are not used the same way for those at home kits because obviously a mother or person isn't running 50 or 100 tests at once to check this for systemic errors. So that would be where we participate and that area is through viral transport meaning.
Deborah Honig
[indiscernible] the bottom is still VTM it's not something different?
Cameron Groome
Welding you know if it's if it's our DxTM, you'll see Microbix on the label.
Deborah Honig
Okay, I actually have a rapid test somewhere around here and I go grab it.
Cameron Groome
Well, this should be for at home collection, Deborah not the rapid test.
Deborah Honig
Okay…
Cameron Groome
So if somebody's collecting for collecting at home for the board is testing that's where we play a role.
Deborah Honig
Yeah.
Ken Hughes
So home flow. Being put it in our VTM send it back through a pharmacy or through a designated area for subsequent testing…
Deborah Honig
What's the liquid they use of the rapid tests?
Ken Hughes
It can be anything from specific reagent to just saline solution that physically drives the sample through the strip…
Deborah Honig
Got it…
Ken Hughes
It wildly varies between tests.
Deborah Honig
Okay. I think that's everything on QAPs. Let me just double check. And I had one question on the antigen business. So what sort of recovery are you currently seeing in that side of the business?
Ken Hughes
Antigen business, we continue to see a lower level of antigen business, we don't anticipate that it will recover fully to the million a month pre-COVID. In 2022. There's still sadly quite a number of medical procedures that aren't getting conducted because of COVID. And people, you know, people not seeing their doctors and their doctors not wanting to see patients. So that business continues to be under top line pressure. But we are certainly continuing to work to enhance the margin in that business and happen quite some success in, in doing so. So we'll be poised when the top line starts to recover, will get more margin out of every dollar of sales associated with that business. Jim, what, what would you want to supplement on that? Just from…
Jim Currie
I think from a top line perspective, I think you're correct. I mean, we're not expecting the pre-pandemic level of revenues. However, we have seen some limited growth over the last year in that business and the margins have are starting to improve quite well. And so we're poised to produce greater margin from that business, when we do get back to post-pandemic levels.
Ken Hughes
The group is likely well aware of the implementation of the bioreactor strategy, and rubella, which is now bearing great fruit with regards to margin and efficiency and shout out to the team here and the technical manufacturing team and quality control team for pushing that through. We're applying that type of discipline to all our products in the antigen space and solely to maximize margins, everything we do here, and that will continue. And so hopefully, the top line and the margin, bottom line will continue to increase in what is really a reasonably mature market will continue to grow within it.
Cameron Groome
Some good opportunities there, though, you know, we are seeing opportunities that will emerge ultimately in Asia as the stabilizes and we have some other ideas that we're pursuing, that may make the avatar [ph] iness even more interesting.
Ken Hughes
And there's a reason why we're putting together a BSL three containment suite of Chromebooks [ph] l in this in fiscal 2022 per business plan.
Deborah Honig
Can you maybe explain about [indiscernible] and how you achieve that status?
Cameron Groome
Which process in which status Deborah?
Deborah Honig
Sorry, did you just say that you're - sorry, maybe I misunderstood Ken, I thought you're talking about upgrading to a level three.
Ken Hughes
It's about the level of containment of the individual viruses that you can grow in any sort of scale. So you're looking at finishes and airflow, general and general safety and containment associated with that. Right now we have a manufacturing level CSCL or BSL two plus and that's what the virus is we can other pathogens we are currently growing activate for antigens and for our cuts, to handle like something like real Corona - that real cool SARS cov-2 or some of the more interesting tropical viruses, you need some additional air capabilities within the labs. And that's what we're building out. There's a number of opportunities in this regard. Also, you know, just you can deal with nasty pathogens, if you can contain them properly, and we would never grow nasty ones without proper containment. Put it that way.
Cameron Groome
Correct. And these distinctions, for example, Dan gay [ph] amongst the tropical diseases, dengue is classed as contained in level two or biosafety level two, but very analogous viruses such as Chikungunya or Zika are classed as level three and it will help our business to be able to safely work with a more fulsome spectrum of organisms. And to do so with the diligence that we've demonstrated over 30 plus years.
Deborah Honig
Okay. And the margin expansion you discussed on the antigens. Is that a result of the conversion that happened to bio reactors or is that a number of different factors?
Cameron Groome
It's a number of different factors. Certainly, you know, the bioreactor conversion has been one that took a product with subpar margins and has moved it closer to where we want to see it, still not fully there yet. And that same level of diligence and innovative thinking is being applied to a number of different antigen products to really get the maximum margin dollars out of each one. And we have seen, frankly, you know, in a negative impact, had we not done that work, we would have had the antigen business being a drag on the company rather than a benefit to the company if we were achieving the margins of several years ago, and it's seen some of the reduction in the sales level. So we've seen benefit from these improvements, but we'll see a much greater benefit, when sales research through the million a month range that they were pre COVID, that'll be much stronger results than we've ever seen so far from that business.
Deborah Honig
Okay. Does technology like that of PON technologies represent a threat to MDX patent technologies claims micro LJ and genetic engineering have created new opportunities versus mammalian cells? Et cetera? I don't know if I put you on the spot. I hadn't heard of that company previous…
Cameron Groome
Oh, no, we know, we no contact we like them. We've had discussions with Bondtech. There are a number of platforms that that one can look at, and consider their multiple ways of making synthetic antigens synthetically. But they're very many variables that determine whether an antigen is acceptable for use in a diagnostic test. And we make some synthetic antigens ourselves already, for example, our clients tend to be looking at an absolute gold standard, they want the real virus made in a real mammalian cell, so that it is as sensitive and specific as possible when put into their tests. So they tend to be incredibly quality conscious and very conservative. So, you know, we may look at technologies like Pond, but it will be many years before we would see changeover from our customers one way or the other.
Deborah Honig
Okay. And then I had a question about antibody testing. Do you make any products for antibody testing at this time?
Cameron Groome
We have developed QAPs to support COVID Serology tests and that's something we have available. The use of serology testing to look at your antibody levels for COVID has not taken off the way many felt it would. And, you know, governments have expressed some reluctance even to have people test their antibody levels because they don't want to dilute the message of vaccination. But we will ultimately, I think, see a role in that to say if we're, you know, people are going to lose patience, you know, when their booster looks like a coffee loyalty card and you're saying, you know, every seven shot you get a free cup of coffee is not going to go over well. So I think ultimately, we will see an adaption to say, Do you have a protective level of antibodies if you're at risk? Otherwise, we have to recall there are the memory cells that for somebody who's otherwise healthy and low risk may be adequately protective in and of themselves. But for those at risk, that may be a role for serology testing to maintain a higher level of protection. Ken what would you have to say about that?
Ken Hughes
Only that we do indeed have a cup. And we're actually developing a suite of serology cats with different specificities. And so yes, I mean, we complete the portfolio, we have antigen caps, we have PCR and nucleotide caps. And now we're going to have we have serology cuts as well. And as the market evolves, we will be then immediate.
Cameron Groome
Those who haven't yet been taken through the red process to be fully IVD controls just because there hasn't been the pressing need and we've been prioritizing that that's something we could readily add to the lab testing eligible product portfolio as a red control product when that market becomes ripe.
Ken Hughes
And we have done some qualification in third party laboratories and they work beautifully as expected.
Deborah Honig
Interesting, I kind of like that concept actually where you can your serology tests and tests you have not you know how many vaccinations you've had or whatever it just tells you? Are you immune? How far away do you think we are from being able to implement that like a rapid test or like efficient turnaround time?
Ken Hughes
Well, some of those tests are available now as strip with a drop of a few drops of blood can assess in a qualitative or semi quantitative fashion, the level of antibodies to spike protein, for example. So those exists now. And they were created very quickly, following the discovery of COVID, the question is more than what's the - what's the health care and clinical relevance of that testing? And how do we deploy it? It was, it was nice to know, but not too relevant before we had vaccines are widely available now. It's it becomes more relevant, as we say, to whom do we give those vaccines and what intervals do we look to give boosters?
Deborah Honig
Okay, couple more questions. Just maybe more general questions on your results? When can we expect q1 results? Mid February?
Ken Hughes
Q1 results would be mid February. So we would be looking, just looking at a calendar, probably on…
Cameron Groome
The 10th and the 14th.
Ken Hughes
Yeah, exactly. So that would be the timeline for the release of Q1 results. And q1 we are just looking at preliminary figures now. And we'll certainly discuss them in due course, but it is looking to be a quite a reasonable top line and a positive bottom line.
Deborah Honig
I know previously, we're guiding to seven seasonality in Q1, is that a typical seasonal sort of slower…
Ken Hughes
Q1 is typically slower. It's historically there - there have been the proficiency testing industry in the US. These are the groups that periodically check how the labs are doing in their third party agencies that give the labs a blinded group of samples that they must complete in a given timeline, those events. The tradition in the US and Canada has been that there are three events per year for the labs. And that's meant that we would typically ship product in Q2, Q3 and Q4 to support those events. We did see a few more shipments for proficient - proficiency testing in our Q1 of this year. But Q1 has historically been a slower quarter for Microbix. We of course, came in with shipments on December 24, Viral Transport media, which certainly helped the complexion of our Q1 numbers. We did offer put in a free Christmas hat with the order but - but it was deemed unnecessary. The other thing I would mention Q1 we had anticipated taking a non-cash charge of approximately $0.5 million in our Q1 associated with the early repayment of our debenture that ends up being taken in Q4 due to an accrual based methodology that was driven by our auditor, so that charge was taken in Q4 not in Q2 - d will not therefore occur in Q1.
Deborah Honig
Okay, and then are there any other seasonal trends that you see year to year or any other seasonality in the business?
Ken Hughes
Well I think you know, broadly speaking, respiratory viruses tend to circulate more in the winter in the Northern Hemisphere. So we will have some inherent seasonality in the respiratory business in other sites of testing. That is not the case. You know, for example, there's not a specific seasonality on things like HPV and other you know non-respiratory viruses, but when it's cold and damp out and people are congregated indoors and viruses don't get burned off by bright sunlight quite so much. They tend to circulate more in the wintertime. But again, there's an offset that some our shipments would tend to for that purpose would tend to happen a few months before the season if our customers are planning appropriately.
Deborah Honig
Got it. Right. And then final question. So what are the main catalysts for investors to look forward to in 2022 ?
Ken Hughes
I think some of the catalysts I'll invite Jim and Ken to step in as well. But some of the catalysts, I would look for more industry alliances that we'll be looking to put together. In terms of our QAP sales, I think the scaling and automation steps that we're taking to drive - drive and support growth, as well as with any luck [indiscernible] Jim and Ken what would be your some of the ones you want to highlight?
Jim Currie
Connectivey and increasing sales, X, Ontario downstream of the automation of DxTM would be a good - be good example, continuing, enhancing capabilities in the city - within our systems to support this growth with our inventory management and supply from there. But really, it would be diversifying geography as well as product portfolio as we move forward. And I think we're nicely set up to do exactly that in 2022.
Ken Hughes
And I think deploying the capital that we've been provided by our investors with in a variety of areas and expanding the business, whether it's research and development, sales and marketing, or with the expansion of the facilities, and the automation is incredibly important. We're also looking at our systems as well as enhancing our internal systems, ERP solutions and QMS systems to support the growth of the business as well.
Deborah Honig
Okay, great. Well, that's pretty close on the hour. Thank you, everyone, for participating for your questions. Cameron and team is there anything that you wanted to discuss today that wasn't discussed?
Cameron Groome
One thing I'll mention Deborah's, I will be - have some stock options that, that I negotiated when I came on as CEO that are expiring in 2022 will expire in August, I'm going to be exercising those in four tranches over the course of the year. One after Q4, shortly when after Q1 results are announced one after Q2 results are announced and one after Q3 results are now so just that everyone is expecting that I will be meaningfully adding to my net holdings. But there will be some of those for tax purposes and capital purposes that I cannot hang on to just because it's would be too much of a strain on my liquidity. So I will be adding to my net holdings, but will be active in four tranches across the year.
Deborah Honig
Now then I'm in. Okay with that, well, I think we can end it there. Congratulations on another fantastic year [indiscernible] this company continues to get better and better congrats on Q4 and sliding that VTM or in before your end, I think the market was anticipating that. So lots to look forward to excited to see the Q1 results. And yeah, thank you so much for your time.
Cameron Groome
Thank you very much, Deborah, it's been great to have your support in and that elaborate through the year. We've done our very finest work, I think in driving real value growth for shareholders. And that's something we're going to continue to do. We've got a great team, the three of us here, me, Jim and Ken are just scratching the surface of, of the great people that we have working with us. And it's, it's amazes me every day, just the talent that we have within a company of our size.
Deborah Honig
Great. It's always a pleasure and what a great way to start the year off. So congrats to you all. If anyone has any additional questions, feel free to reach out and I'll get those answered for you. And yeah, everyone have a good 2022.
Cameron Groome
Thank you and thank you for everybody on the call taking - taking your valuable time to spend with us.
Ken Hughes
Absolutely.