Good morning, and, welcome to this, webcast presentation of, quarter two and first half year results of, Gentian Diagnostics. My name is Njaal Kind , I'm the CFO of, Gentian Diagnostics. And with me today, we have, our CEO, Hilja Ibert, and also our Chief Scientific Officer, Aleksandra Havelka. Before we get started, I want to remind you that you can pose questions using the questions box, in the application. And, we will, address those questions, in the Q&A session that we will start, immediately after, the presentation. So, with that, I would, like to introduce, Hilja, that will, provide, an overview and status, and I will be back, with the financials, a bit later. Hilja?
Thank you very much, Hilja. Good morning, everybody. Before I start, I would like to make you a little curious about the results we have to present later on, on Q2 and H1. I say that rarely, but I'm really, really pleased with the outcome of our work so far. So that you can put it into context of our company, I will introduce you now to the company. The very first element is what's the value we provide to the market? The value is articulated in our mission statement to innovate efficient diagnostics or to innovate the efficiency of diagnostics, which enables, ultimately, the clinicians to take better treatment decisions. Keep that in mind, because with this kind of relevance, you can achieve good results.
If you're not relevant to clinicians and to the laboratories in this world, it is not so likely they're driven by your products. We have received several times the questions to explain a little in what space we are working in. So what does it mean, efficient diagnostics? The life science market can be split into two pieces from a very high level point of view. One is those products which helps clinicians to treat patients, and the other one is which helps clinicians to diagnose the disease.
Within this diagnostics part, that is our space, you can further split it down into the part where you do the diagnostics on the living patient, a good example is X-ray, and the other part is where you do the diagnostics part on the samples of patients, blood and urine and wound swabs, for example. So those samples are then examined mainly in laboratories on all kinds of different technologies. This is our space, and what can be said about this kind of diagnostics market, it is called the in vitro diagnostics, because we are not acting on the living patient, only on the samples. Those samples, again, as I mentioned before, are examined with different kinds of technologies. Our expertise currently are the immunoassays.
The immunoassays, again, are examined in different kind of ways, and here our core expertise is this so-called PETIA technology. We do not go deeper into the technology today, but important for you to know is that we focus and that we are what we do, we do very, very well, and that is understood by our customers and as well by our partners. So the PETIA technology is what drives currently our growth. But PETIA and technology alone is not good enough, and so we need to address burning problems in the market, and here we are getting now closer to our mission statement. The problem in the market is that laboratories look for productivity, especially as they need to provide more results because they receive more samples from clinicians with more or less the same resources.
But those results should be provided as fast as possible, because the clinicians would like to take treatment decisions based on information. And information coming from the laboratory are often key for a good diagnosis, the diagnosis of a disease. For the laboratory itself, dealing with this productivity issue, is that they would like to shift biomarkers which are demanded more and more, so higher volumes to bring them to those instruments they have in the lab, which can run much higher throughput. Often, biomarkers are manual examined or with low throughput instrumentation. And that is the solution we provide. We enable laboratories to shift biomarkers, clinical relevant biomarkers, to a high throughput, highest possible throughput instrumentation.
We, by doing so, enabling to provide results within, to examine them within 10 minutes, so means within 30 minutes, 90 minutes, they can be available to the clinician in a high efficient hospital. Higher throughput, three-10 times higher throughput, faster results to clinician. That is a very powerful value proposition. Again, one of the a majority of why we achieved these great results, which you will hear later. We have developed a while ago, growth plan, ambitious growth plan, which was based on seven products. These seven products serve currently estimated market of $1.8 billion. The market growth is expected to be 5%-10% per year because we need optimization to receive data from the in vitro diagnostics.
That is the core of our doing, but our doing is coming from industry-leading expertise. I mentioned before, focus on a certain technology, and that is important. We have, in all departments, a deep expertise about what we are doing, and that is one of the core, and that is what is driving as well our current success. Current success is based on a go-to-market model, which we consider as very efficient. As a small company, we cannot assume to build sales forces all over the world while we are serving already laboratories all over the world. Therefore, we achieve the majority of our sales with global IVD partners who provide the instruments to the laboratories. And as part of the instrument, they offer our reagents as well as part of their package.
So with this, we have access to thousands of sales reps from our partners all over the world. Our job is more to make it our partners easy to sell and to argue the benefits of our assay versus competitive biomarkers or technologies. I mentioned before that we are encouraged by the results of Q2. But we had as well in the former years, in fact, from 2019- 2022, achieved an average growth rate of 28%. That is quite encouraging for us. As you will see later on, we continue with growing as well in 2023. I mentioned before the seven products.
As we have Aleksandra here today, she will speak about some of them a little bit more in detail, so therefore, I will not speak a lot about this, this list of our products. Important, again, for you is to remind, be reminded, all of them drive productivity for the laboratory because they can shift those bio, biomarkers now to the highest possible throughput, and all of them have individual clinical benefits. And today, we would like to highlight certain achievements from Cystatin C, our now, now number one product. We would like to speak about GCAL, our perceived blockbuster, which is in market development, and obviously the third product, which is in product development, NT-proBNP. And all, for all three products, we assume that they will support our growth as well in the future.
With this, I hand over to Aleksandra. You introduce yourself, maybe?
Yes, I will. Thank you, Hilja, and hello, everyone. My name is Aleksandra Havelka, and I am Chief Scientific Officer in Gentian. Today, I will focus on some highlights related to three of our products, and I will start with Cystatin C. As most of you know, Cystatin C is biomarker, which is used to measure kidney function. It is used today in routine to detect reduced kidney function in an early stage, but also to follow therapeutic monitoring of patients with a kidney disease. Cystatin C has several advantages compared to creatinine, which is another old, very well-known biomarker for estimation and diagnosis of reduced kidney function. However, creatinine has several limitations, and those are related to unreliable results of creatinine in patients with increased body mass.
These results are also impacted by muscle mass, ethnicity, and protein. All these limitations of creatinine are addressed and highlight several guidelines that will be published in 2023. Those guidelines are coming from reputable organizations, such as National Kidney Foundation and the American Association for Clinical Chemistry, recognize Cystatin C as a reliable biomarker for early diagnosis of kidney failure and good biomarker for monitoring of the treatment of patients with a kidney disease. These guidelines also emphasize use of Cystatin C in combination with creatinine or alone, when creatinine results are unreliable and when more accurate results are needed to estimate diagnosis or to follow the patients with kidney disease. So we are very optimistic, and we believe that-...
Recognition of Cystatin C as a good and accurate biomarker together with Creatinine will lead to significant increase of use of Cystatin C globally and also in the US where the majority of these guidelines are coming from. Another product and another biomarker I would like to mention today is our GCAL assay, which is used for analysis of biomarker calprotectin in blood, in serum and plasma. So in this quarter, we have been able to report the proven value of calprotectin in patients admitted to emergency departments with suspected infection.
So we have in April, we have presented results from a prospective study done in collaboration with Charité Hospital and Labor Berlin in Berlin, where we have studied the value of calprotectin in early diagnosis of bacterial infections in patients admitted to emergency department. We have been able to show that calprotectin is not only a good biomarker for detection of bacterial infection, it is also a good biomarker for estimation of disease severity, prediction of complications such as organ failure and mortality, and also biomarker that can be used to predict sepsis. So these results have been presented at the meeting for European Congress of Microbiology and Infectious Diseases in Copenhagen in April, and the aim is to publish these data during this year.
We have also done economic exercise and have developed a model which shows that there are strong health economic benefits for use of calprotectin in intensive care. That is published. Using calprotectin, you can detect infection 24 hours before onset of clinical symptoms, which means that you can start treatment of patients 24 hours earlier than what clinicians should do based on the clinical symptoms. So in this health economic model, we have shown that calprotectin not only save lives, but also save costs and reduce length of hospital stay. We have shown that using calprotectin in ICU cohort, you can reduce hospital stay by up to 2 days in intensive care units and up to 8 days in a general ward, and which will result in cost savings of approximately 15,000 EUR per patient.
This study has been out, it has presented as a poster at several meetings, but is now published in the scientific journal Biomedicines. Third product that I would like to mention today is NT-proBNP. As you know, NT-proBNP is biomarker for detection of congestive heart failure. Gentian will develop an assay with several advantages. The first advantage is that we are developing first turbidimetric assay on the market, which will result in higher productivity and cost savings in the laboratory. Our assay will not be affected by glycosylation of NT-proBNP molecule, which is the case with other existing assay on the market. The development of the product and of the assay is currently in optimization phase, and we are making in the development.
During this quarter, we have worked on prototype stability, and we have been able to extend stability of the prototype, which is good news. And we have also been able to use this prototype for the first time for measurement of NT-proBNP in samples from healthy volunteers. And this is challenging because in healthy people, the level of NT-proBNP is very low, and we know that this is a challenge for the troponin assay. But however, we have been able to correctly measure low concentration of NT-proBNP in healthy people. So we are very encouraged by these results, and the next step will be, of course, to measure samples in pathological samples from patients with cardiac disease, and evaluate performance of our assay in the pathologic population.
In parallel, we are also working in understanding of the impact that this glycosylation may have on the level of NT-proBNP in the blood, which is very important for calibration of our assay, but also for future harmonization of all assays on the market. So with this, I will hand over to Hilja, and I will be happy to answer your questions in Q&A session.
Thank you very much, Aleksandra. Yes, so, we have talked about our, from the additional example of our, calculating now, the value product into U.S. dollar, with our seven products, we are on the market, or we to be more complete in U.S. dollar. There is room for the growth we have, planned for us. In our assumptions and in our business model, we aim market share, of course, 13%, depending on the product. We take a share of this market share, of this sales of 30%-50%, depending on the contract in place. These are always and obviously, averages. As you can see, we have segmented the market first in our established products. As you hear the number one example, but as well, belongs to the so-called established products.
We have two sub-segments with GCAL, the calprotectin product from serum and plasma, one for the severe infection/sepsis part and one for the inflammation, which is rheumatoid arthritis, for example, and which is a market on its own. NT-proBNP, as we mentioned before, a highly demanded biomarker, has a category for, on its, on itself. So all in all, an attractive market, as well, due to the growth, which is estimated by the, to be 5%-10% during the next four-six years. Again, how do we sell our products? We have already now, contracts in place with leading IVD companies, those, top five who are, installing those instruments and selling those instruments and the respective region menu to the laboratory. Siemens, we had more recently rolled out.
We have a longer standing commercial partnership with Beckman Coulter on Cystatin C, which is very fruitful, and as well, our partner, Buhlmann, the expert of fecal sample handling, a good partnership, the IVD. Our first 2019 and 2020, and currently in all the top 10. Before I, good news on GCAL, and GCAL will be one of those products to accelerate our in the future. With NT-proBNP, we have to develop the product, we have to finalize the product. It's a breakthrough product, no activity level, and we have heard from Aleksandra made the right steps in the right direction. The same is obviously more products to bring to the market. We invest significantly into R&D, and we have several pipeline products in parallel to NT-proBNP in the earlier stages of the development.
Our commercial team is very much engaged with existing, but as well, new commercial partners, top IVD companies who are always eager to increase their menu with promising biomarkers. We aim to improve our gross margin from currently about 50%- 60%, mainly based on the volume increase, which we envision, and with certain leverage of the investments made, and cost discipline and control, we assume to have the potential for an EBITDA margin of 40%. I invite you now to compare what we have achieved in Q2 and H1 to our long-term ambition, and hopefully you will agree with me that we are on a good track. Thank you. So thank you so much, and I hand over to you.
Thank you very much. I will provide a rundown on the connections. This morning, we are very pleased to announce another record quarter with NOK 34.2 million on sales. If you look at the first half, it's a record as well, with NOK 65.6 million on sales, which is 30% higher than the corresponding period last year. We do experience some currency tailwinds, meaning that we take advantage of the current currency situation. Adjusting for that, we had growth in the first half of 17%, so still strong underlying growth on our existing products. Combined with a pretty decent cost picture, which I will get into a little bit later.
We also report a positive EBITDA for both the second quarter and for the first half. If we compare the EBITDA of NOK 3.1 million for the first half to the EBITDA loss of NOK 5.4 million last year, this becomes an EBITDA improvement of 8.5 million compared to the same period last year. Quite strong. We have also chosen to highlight this quarter, and our operation in Sweden of our own products and also market products in the Scandinavian market; we have seen sales increase 500. Previous quarters. The underlying performance is good, but here we also take advantage of the currency payments as described.
As Aleksandra explained, we still see a very positive environment for Cystatin C, now backed by changes in guidelines and recommendations, and we intend to take advantage of that. The last thing I will mention is the acquisition of Gene Tech that we closed on 3 July . It was announced in June. It's not a big acquisition, but it is important for two reasons. The operational reason is that we now gain control over some critical competence related to our production and purification of antibodies. And we also believe that we can realize some operational efficiency from Gene Tech. And the second reason is that Gene Tech also have some unique R&D capabilities that we will integrate into the Gene Tech organization.
So, all in all, we believe that this is an acquisition that will strengthen us going forward. So, focusing on the sales, as I said, we have a record quarter, NOK 34.2 million. Let's start with the geographic split. We have previously said that the U.S. is a focus area for us. We want to grow sales. It's the world's biggest healthcare market, and our sales does not reflect that for the moment. But our efforts are yielding results, although still at a low level, we have more than 80% growth in revenues in Q2, 70-ish% in H1.
So we are definitely on the right track in terms of increasing our sales in the US. Europe are our biggest market. We have seen sales increase by 32% in the quarter. And in Asia, there is what we call a base effect from Q2 last year, where we had very high sales. So if we look at H1 compared to H2, H1 2022, so first half year this year compared to first half year last year, you'll see that the situation is almost it's quite stable, so we expect Asia to also grow going forward. Looking at the different products, we also focus on first half compared to first half last year. Our largest product is the Cystatin C.
Now almost NOK 26 million in sales, 18% up from corresponding to last year. The biggest growth driver on the product side is the fCAL turbo, which had an increase of 37% compared to the first half last year, and now is at NOK 21.5 million. Third party products, I spoke about, and then the other products like fPELA et cetera is also showing positive growth in the quarter, 18%. It's a set of strong figures driven by, I would say, growth on all products and good development in U.S. and Europe. Looking at the cost, so this is the fixed cost, the operating expense.
We actually have a lower OpEx in quarter two this year than last year. So, that's a good cost discipline. If we look at the first half compared to last year, we had an increase of 4% in all our operating costs, and that can be compared to, for instance, the increase in organic sales by 17%. So, I think this cost development, compare them to the revenue development, really is an indication of the scalability of this business. So good margin improvement there. I think this is my last slide. I can highlight that we had positive cash flow in the second quarter. We accrue or we gained NOK 4.8 million on cash during the quarter.
And if we look at the first half, so first and second quarter, we have a cash burn of less than NOK 1 million. I think it's NOK 600,000 or NOK 700,000, so very close to cash breakeven. CapEx, as you see, is significantly down compared to the corresponding period last year. And that is, of course, because last year we finished up and the facility expansion here, where we basically laid the foundation for a significant volume and activity increase here in our facility here in Moss. So I think the CapEx level is now at a more recurring level than what it was last year.
Yeah, again, the cost base is we have a strong influence from personnel costs on our cost base. It's more than 50% of our OpEx. So of course, we are satisfied that we have managed to control costs to the extent we have, with that in mind. I'm happy to take questions in the Q&A. Please use the questions box. Let's see, what is the next? It's the Q&A, in fact. So then I will invite both Hilja and Aleksandra out there, and I will try to read out some of the questions that have come in.
It's not too busy on the screen at the moment, so please, if you have any questions, post them now. It will take a few seconds before we can see them. But I want to start off with Cystatin C and really this change in recommendations that we have, that you spoke about Aleksandra. And I think, do you think it would be able to, if you would be able to say, to quantify some of the impact on the market, given assuming that these recommendations were fully implemented? I think it might be difficult for the audience here to get a good grasp on that.
Yeah. So, so as I mentioned, these recommendations highly recommend use of Cystatin C in addition to creatinine whenever creatinine results are unreliable or can have impact on a clinical decision point. This means that Cystatin C is recommended to be used, for example, in all patients with abnormal muscle mass. So Cystatin C will be measured or should be measured in people, in bodybuilders with higher muscle mass, in people with reduced muscle mass or old people, people with malnutrition, yeah, children-
Amputation.
Amputation of limbs, et cetera, et cetera. In addition, there is a race or ethnicity impact, where Cystatin C has been shown to be biomarker, because there is no difference between different races, which is the case for creatinine. So, yeah, an estimate, we know today that based on a dialogue with clinicians and market reports, that Cystatin C today measured in four out of 1,000 samples, where creatinine is analyzed. So four Cystatin C in 1,000 creatinine samples. With these guidelines and these strong recommendations, we believe that the volume of Cystatin C should increase at least four-five times in the U.S., but also even globally. So yeah, if we want to translate that in numbers-
We can, we can probably make the link to our capital market day, which we had in Q2, where we spoke about Cystatin C. Our estimations there were a little bit more careful from, from a global level. So we estimate the market currently to be $100 million outside of China, so ex-China. And we assumed a 2.5 increase. So now, globally. But we know that the response to this guide in the US is strong, and I think that is quite encouraging that the effect of US might be even then further increased to the $250 million, which we had estimated, maybe it will be even a little bit more.
Okay, thank you.
Or much more.
As a follow-up question on Cystatin C, more commercially related is... We have a strong relationship with Beckman Coulter regarding Cystatin C, and the question is, could it be other similar relationships or are we look into, let's say, a more exclusivity around one product and one partner?
No, I think that's a very good point. We do not have exclusivity. So with Beckman Coulter, our collaboration is related to their implementation. And we have announced a contract with another partner already from U.S., which doesn't want to be named, but it's a very important IVD player. So as we speak, our commercial team is very busy, of course, to gain even more partners. Our major advantage is the turbidimetry and our quality. We are definitively understood as a quality leader from a product point of view, but as well from a team point of view, as we have a strong expertise within our team, starting with Aleksandra, but many more in our team. And that is very welcomed by our commercial partners.
Oh, thank you. Should we switch to NT-proBNP? So we say that we have achieved greater stability on the product during the quarter. And the question is if we could elaborate, and maybe this is a question for you, Alexa. Elaborate on the effect and the significance of having achieved better stability.
Yeah. So, stability of a product is very important both during development, because if you have a stable prototype, it gives you time to work on the same prototype and do more experiments. This is even very important for the final product, because what it means is the stability is synonym to shelf. Long stability to have and within the optimization phase. As soon as we have finalized the optimization, we'll be sure. We estimate another 9-18 months, maybe, work on the product.
We have complete in the on the call. So do you want to thank you again, both?
Thank you very much for your time today and listening to us, and we are looking forward seeing you then for the Q3 presentation. Goodbye.
Thank you.