Gentian Diagnostics ASA

OSE:GENT

Earnings Call Transcript 2023-Q2

[Njaal Kind, executive]

Good morning, and welcome to this webcast presentation on the Quarter 2 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. [Operator Instructions] 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?

[Hilja Ibert, executive]

Thank you very much, Njaal. Good morning, everybody. And before I start, I would like to make you a little bit curious about the results we have to present later on our Q2 and H1. And I'd say that really, but I'm really, really pleased with the outcome of our work so far. And so that you can put it into context of our company, I will introduce you now to the company. And the very first element is what's the value we provide to the market. And the value is articulated in our mission statement. To innovate efficient diagnostics or to innovate the efficiency of diagnostics, which enabled ultimately for clinicians to take better treatment decisions.

And 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 that they will buy your product. We have received several times a questions to explain a little bit more of the 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. And within these diagnostics part, that is our space. You can further split it down into the part, where you do the diagnostics on the living patients, 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 spots, 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 today, is in this kind of diagnostic market, it is called 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 -- and as immunoassays again, examined in different kind of ways. And here, our core expertise in this is 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. With 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 I need to provide more results because I 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 coming -- information coming from the laboratory are often key for a good diagnosis of the disease.

But the laboratory itself dealing with this productivity issue is that they would like to shift biomarkers, which are demanded more and more for 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 a solution we provide. We enable laboratories to shift biomarkers, clinical relevant biomarkers to a high throughput, highest possible throughput instrumentation and we by doing so enabling to provide results within -- to examine them within 10 minutes for me it's within 30 minutes, 90 minutes, they can be available to the clinician in a high-efficient hospital setting. So the benefit is higher on throughput, 3x to 10x higher throughput faster results to clinicians. That is a very powerful value proposition. And again, one of the majority of why we achieved these great results, which you will hear later.

We have developed a while ago growth plan, vicious growth plan, which was based on 7 products. These 7 products serve currently an estimated market of USD 1.8 billion. And the market growth is expected to be 5% to 10% per year because we need automation to receive data from the in vitro diagnostics. That is a core of our doing, but our doing is coming from industry-leading expertise.

I mentioned before, focus -- focus on a certain technology -- and that is important. We have, in all departments, deep expertise about what we are doing, and that is one of the course. And that is what is driving as well our current success. Current success is based on the 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 as a majority of our sales with global IVD partners, who provides the instruments to the laboratories. And as part of the instrument, they offer our region 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 work is moreover to make it our partner easy to sell and to argue the benefits of our assay, as well as competitive biomarkers or with 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 to 2022, achieved an average growth rate of 28%.

And that is quite encouraging for us. And as you will see later on, we continue restoring as well in 2023. I mentioned before the certain products, as we have Aleksandra here today, she will speak about some of them in a little bit more in detail. So therefore, I will not speak a lot about this list of our product. Important again for you is to be reminded all of them drive productivity for the laboratory because it can shift those 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 one of our #1 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 also all 3 products, we assume that they will support our growth as well in the future. So with this, I hand over to Aleksandra and you would introduce yourself, maybe?

[Aleksandra Havelka, executive]

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 3 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 routines to detect reduce 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 intake. So all these limitations of creatinine are addressed and highlighted in several guidelines that will be published in 2023. And those guidelines are coming from reputable organizations such as KDIGO, which is global organization for improved outcome in patients with kidney failure. National Kidney Foundation and the American Association for Clinical Chemistry.

All the guidelines recognized Cystatin C as a reliable biomarker for early diagnosis of kidney failure and good biomarker for monitoring of the treatment of patients with the kidney disease. These guidelines also emphasize use of Cystatin C in combination with creatinine or alone when the 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 U.S., 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 infections. So we have -- in April, we have presented results strong prospective study done in collaboration with Charité Hospital and Labor Berlin in Berlin. But 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 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 health economic exercise and have developed a model, which shows that there are strong health economic benefits for use of calprotectin in patients admitted to intensive care unit and this model is based on a previous study done in these patients, that is published in 2017, but we have shown that 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 saves lives, but also save costs and reduced 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 unit and up to 8 days in the general ward and which will result in cost savings of approximately EUR 15,000 per patient.

This study has been out. It has presented as a bolster several meetings, but is now published in the scientific journal of biomedicine. 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 molecules, which is the case with other existing, but their assays on the market. The development of the product and of the assay is currently in optimization phase. And we are making a good progress 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 turbidometric 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 -- 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 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.

[Hilja Ibert, executive]

Thank you very much, Aleksandra. Yes, so we have talked about our products, you have this Aleksandra as well an additional example of our management team, which we as I mentioned before is leading industry experts, calculating now the value of our product into U.S. dollar. As I mentioned before we assume that with our 7 products, we are addressing billion a market or we serve a market, in fact to be more concrete of USD 1.8 billion. So there is room for the growth we have planned for us.

In our assumptions and in our business model, we aim for a market share, of course in an un-risk model of more than 15%, depending on the product. And are we take a share of this market share of the sales of 30% to 50% depending on the contract and the model we have in place. So these are always and obviously averages. As you can see, we have segmented the market, first in our established product, Cystatin C being here as a #1 example, but as for our GCAL Calprotectin, belongs to the so-called established products. We have 2 subsegments with GCAL Calprotectin product from serum and plasma, 1 for the severe infection/Sepsis part and 1 for the inflammation, which is rheumatoid arthritis for example, and which is a market on its own. And NT-proBNP, as we mentioned before, a highly demanded biomarker has a category for on itself. So all in all, an attractive market as well due to the growth -- which is estimated by the [indiscernible] Group to be 5% to 10% during the next 4 to 6 years.

Again, how do we sell our product, we have already now a contract in place with leading IVD companies those top 5, who are installing those instruments and selling those instruments and respective reagent menu to the laboratory. Siemens we had recently rolled out with GCAL, we have a longer outstanding commercial partnership with Beckman Coulter on Cystatin C, which is very fruitful and as well our partner, Bühlmann that are expert of people sample handling has achieved a good partnership, a strong partnership with the leading company in the IVD stream Roche. Our sales performance in the last years between 2019 and 2022 has been encouraging all along we achieved a growth -- compound growth rate of 28%. And before I hand over to Njaal, summary of our long-term ambition, I mentioned before we aim and ultimately we assumed that there's a potential to achieve NOK 1 billion.

Sales again un-risked and an ambition only, but we believe we are on the right track because our established product achieved, so far we achieving 20% annual growth and more. And as well our plans going forward are promising. We have good news on GCAL and we assume GCAL will be 1 of those products which will further accelerate our growth in the future. And with NT-proBNP, we have to develop the product, we have to finalize the product. It's a breakthrough product, nobody ever achieved those sensitivity levels, and we have as you have heard from Aleksandra made the right steps in the right direction.

The sales are obviously more products to bring to the market. We invest significantly into R&D, and we have several pipeline products in prevalent to NT-proBNP in earlier stages of the development. Our commercial team is very much engaged with existing, but as well as 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% to 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 some potential for an EBITDA margin of 40%.

And 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 much. And I hand over to you Njaal.

[Njaal Kind, executive]

Thank you, Hilja. I will provide a rundown on the financials. And this morning, we are very pleased to announce another record quarter with NOK 34.2 million of sales. If you look at the first half, it's a record there as well with NOK 65.6 million of sales, which is 30% higher than the corresponding period last year. We do experience some currency tailwinds, meaning that we take advantage of the currency -- current currency situation.

So adjusting for that, we had a growth in the first half of 17%. So still strong underlying growth on our existing products. And 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. I mean 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 NOK 8.5 million compared to the same period last year, quite strong.

We have also chosen to highlight this quarter with the third-party product sales that we conduct are from our operation in Sweden, so we are a distributor of our own products and also some third-party products in the Scandinavian market. We have seen sales increase by 112%, so very strong in the second quarter. And 68% in the first half, and this is mainly due to customer wins that we have now converted into steady business, both in Norway and Sweden for the fCAL turbo product, which proves to be an attractive product.

Gross margin of 56% that is strong improvement to what we have seen in previous quarters. The underlying performance is good, but here we also take advantage of the currency payments, as described. And Aleksandra explained, we still see a very positive environment for Cystatin C now backed by changes in guidelines under conditions, and we intend to take advantage of that.

The last thing I will mention is the acquisition of Getica that we closed on July 3. It was announced mid-June. It's not a big acquisition, but it is important for 2 reasons: the operational reason is that we now gain control over some critical competence related to our production of -- and purification of antibodies. And we also believe that we can realize some operational efficiency from here, we had set NOK 2 million from 2024. And the second reason is Getica also has some unique R&D capabilities that we will integrate into the again R&D organization.

So all in all, we believe that this is an acquisition that will strengthen us going forward. So focusing on the sales, as we said, we have a record quarter, NOK 34.2 million. Let's start with the geographical 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 health care market and our sales does not reflect that for the moment. But our efforts are yielding results, although still at the lower level, we have more than 80% growth in revenues in Q2, 70-ish percent in H1. So we are definitely on the right track here in terms of increasing our sales in the U.S.

Europe, our biggest market, we have seen sales increased by 30% 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 will see that the situation is almost -- it's quite stable, but we expect Asia to also grow going forward.

Looking at the different products, we are also focus on first half compared to the first half last year. Our largest product is still Cystatin C. Now almost NOK 26 million in sales, 18% up from corresponding period last year. The biggest growth driver on the product side is still 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, GCAL et cetera, is also showing a positive growth in the quarter, 18%. So 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 2 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% of our operating costs.

And I can be comparative for instance, the increase in inorganic sales by 17%. So I think this cost development compared then 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 accrued -- we gained NOK 4.8 million of cash during the quarter. And if we look at the first half, so first and second quarter, we had a cash burn of less than NOK 1 million. I think it's NOK 600,000 or NOK 700,000. So has it very close to cash breakeven. CapEx as you see is significantly down compared to your 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 significant volume and activity increase here in our facility here in [ Nor's]. So I think the CapEx level is now at a more recurring level than what it was last year.

Again, the cost base is we have a strong influence on -- 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.

[Njaal Kind, executive]

[Operator Instructions] Let's see what is the next, is the Q&A, in fact. So then I will invite Hilja and Aleksandra up here, and I will try to read out some of the questions that are coming. It's not to be seen 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 will 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 will be able to -- if you will be able to say to [ come ] they find sort of impact on the market assuming that these recommendations were should be implemented, I think, it might be difficult for the [ organ sector ] to get the good grasp on us?

[Aleksandra Havelka, executive]

Yes. 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. That 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 body builders with higher muscle mass in people with reduced muscle mass or old people, people with malnutrition, anorexia children amputation of limbs, et cetera, et cetera.

And in addition there is a race or ethnicity impact, where Cystatin C has been shown to be good biomarker because there is no difference between different rates. If this is the case for creatinine. So -- yes, an estimate, we know today that based on a dialogue with clinicians and market reports that Cystatin C is today measured in 4 out of 1000 samples, where creatinine is unlike. So 4 Cystatin C in 1000 creatinine samples -- with these guidelines and the strong recommendation we believe that the volume of the Cystatin C should increase at least 4x to 5x in the U.S., but also even globally.

So yes, if we want to translate, that the numbers.

[Hilja Ibert, executive]

We can probably make the link to our Capital Markets Day, which we had in Q2 when we spoke about Cystatin C and our estimations there were a little bit more careful from a global level. So we estimate the market currently to be USD 100 million outside of China, so ex-China, and we assumed a 2.5% increase -- so now globally.

So but we know that the response to this guidance in the U.S. is strong. And I think, that is quite encouraging that the effect of the U.S. might be even then further increased to the USD 250 million, which we had estimated maybe it will be even little bit more.

[Njaal Kind, executive]

Okay. Thank you.

[Aleksandra Havelka, executive]

Or much more.

[Njaal Kind, executive]

As a follow-up question on Cystatin C more and more commercially related is, we have a strong relationship with Beckman Coulter regarding Cystatin C and the question is could it be of their similar relationships or how we look into, let's say, a more exclusively around the global product and 1 partner comp?

[Hilja Ibert, executive]

No, I think, that was a very good point. We do not have exclusivity. So with Beckman Coulter, our collaboration is related to their instrumentation. And we had announced a contract with another partner already from U.S., which doesn't want to be named, but as well a very important IVD player. So as we speak, our commercial team is very big, of course, to gain even more of our partners.

Our major advance is the turbidimetry and our quality. We are definitively understood as a quality leader from the 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 welcome by our commercial partners.

[Njaal Kind, executive]

Sure. 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 Aleksandra elaborate on the effect and the significance of having achieved that on a better stability?

[Aleksandra Havelka, executive]

Yes. So stability of the 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 self life. So if you have long stability, you have a product with long self life. And our aim is to have at least 1 year of shelf life and preferably even longer. So achieving and expanding stability is very good step into the right direction.

[Njaal Kind, executive]

Okay. Thank you. Yeah, I think, it's not that longest question list we have today. The final one, I have here is do you have updated timeline for NT-proBNP, that you would speak about that [indiscernible]?

[Hilja Ibert, executive]

No I think, you have read the news from Aleksandra which we consider is good news, because we achieved what we expect to achieve and making all steps within the optimization phase. But I repeat, what I always had said before we want to be incredible and incredible means we cannot estimate it. The end of the estimate of the optimization phase, we have to do our steps and some of them take longer, because it's a breakthrough product. As soon as, we have finalized the optimization and you would be the first to know about that. We, estimate another 9 to 18 months, for the remaining development and mainly as well now as the registrations are regulatory work on the product.

[Njaal Kind, executive]

We have come to the end of the questions list. So you want to thank the audience off.

[Hilja Ibert, executive]

Thank you very much for your time today and listening to us, and we are looking forward to seeing you then for the Q3 presentation. Goodbye. Thank you.

[Njaal Kind, executive]

Thank you.