Arcticzymes Technologies ASA

OSE:AZT

Earnings Call Transcript 2024-Q2

[Michael Akoh, executive]

Good morning, and welcome to ArcticZymes Q2 Earnings Report. My name is Michael Akoh. I'm the CEO of ArcticZymes and I'm joined by Borge Sorvoll, our CFO.

Next slide, Borge. I'm going to go through the highlights of the quarter. And then I'm also going to do a recap of our strategic priorities, followed by a sales update. And then I'm going to also go into a biomanufacturing segment update. Then as usual, Borge is going to take you through the financials of the quarter. And we're going to end by going through a Q&A session. Next slide, Borge. I'm not going to go through this highlight slide, so please go to next slide, Borge. The highlights of Q2 2024. It's been a busy quarter for ArcticZymes. We've executed on the key elements of our strategy. We have progressed our innovation portfolio. We've been in dialogue with hundreds of our customers out in the market space. We've also seen that we had an all-time high number of orders for the quarter, just short of 400. So what does that point to?

That points to that in a challenging market, there's still activity, there's still interest and demand for our unique enzymes. We achieved Q1 (sic) [ Q2 ] revenue of NOK 27.5 million, sales of NOK 26.5 million and an EBITDA of NOK 2.6 million. I'm happy to report that we have made significant progress in our partnership talks both within the CDMO area as well as on the distribution front.

Since I joined the company, I've been talking about the importance of partnerships. You've seen us make partnerships early on in the value chain such as partnership with Biomatter on enzyme development. You've seen us done -- do partnerships with acib as well in regards to generation of scientific data. And now we have moved on in the value chain and are now in active discussions with both key CDMOs as well as key life science distribution partners. I'm going to get back to that in more detail later on in the presentation.

Another thing I've talked about is the importance of scientific marketing, the importance of selling scientists to scientists. And during the quarter, we had a successful presentation at the American Society of Gene & Cell Therapy, where one of our scientists did a very good talk on SAN HQ GMP. And that talk actually also fueled our partnership talks, made them progress even faster at some of the -- as some of the partners we were talking to were present during that presentation. So a nice outcome of that talk by one of our scientists.

Our strategic priorities, it's really all about building a platform for long-term growth, and the journey has started. Short term, we're going to continue the journey to become even more market-driven. We're focusing a lot currently on our commercialization, our ability to commercialize our unique enzymes. Starting already in regards to the definition of the products by having a strong product management team into place through interacting with key opinion leaders that are going to give us input on specifications for future enzymes as well as be ambassadors for the enzymes when they are launched. We're also making changes to our commercial team to ensure that we have the best possible commercialization effort in place. Channel development through partners is also a key element. We have five business developers currently working. More than 90% of our sales goes through these five individuals. They're doing a great job. But the market is large, the customers are many, and we believe that we need to complement our direct channels with partner distribution as well. Scientific marketing, extremely important. I talked about our talk at the American Society of Gene & Cell Therapy. You have most likely also seen a recent webinar that we did in Q2. And we're going to do another webinar with our partners in Austria in mid-September where we're going to reveal very interesting data highlighting the benefits of our M-SAN nucleases.

Regulatory compliance is key to penetrate the biomanufacturing market. We have started that journey. We launched our first GMP-grade enzyme in Q1. And within the next 12 months, we're going to launch two new GMP nucleases plus an ELISA kit. So within the next 12 months, we are probably going to have the strongest portfolio of nucleases within the biomanufacturing segment. So it's about having competitive products today and ensuring that you also have competitive products going forward. And we are progressing according to plan in this regard.

Molecular Tools is a focus and will remain a focus and we've developed new application data as well as repositioned some of the enzymes to boost sales. On a more long-term basis, we have seen that with our capabilities within enzymes, there is a unique opportunity for us to build an enzyme portfolio targeting the advanced therapies biomanufacturing space. That journey has also started. We're working together with a number of partners. We got a grant as I talked about of NOK 12 million (sic) [ NOK 1 million ] from the Norwegian Research Council, that's going to support the development of new enzymes for the advanced therapies biomanufacturing market.

Next-generation salt-active nucleases. That journey has also started. As I talked about, we announced a partnership with Biomatter. Biomatter is an AI enzyme engineering company. I had the pleasure of visiting Biomatter early on this week to discuss the progress in developing next-generation salt-active nucleases. And I was very impressed to see how far they have come in a very, very short time.

So currently we have two new exciting variants that our discovery teams are working with ensuring that we have competitive products also in the future. We've also had a large scale innovation projects running during Q2. And the purpose of this project was to define the future of our Molecular Tools portfolio. So we now have a very clear list of enzymes that we're going to start working on in discovery and development phases going forward.

M&A opportunities, we have talked about that before. Our focus is really now on executing on the short-term initiatives on the left-hand side. And then we will see if M&A becomes relevant at a later stage within these three categories that I mentioned. So a lot of activities [ out of ] progress on the strategic priorities. We can't do anything about the current market conditions. But what we can do is ensure that we are positioned in the best possible way, in the strongest way when things pick up again, so we can grow and take market share.

On to the sales update of Q2 2024, combined sales, as mentioned, for the quarter of NOK 26.5 million, which is a slight decrease from Q1. And the distribution of sales was approximately 52% of sales came from EMEA, whereas U.S. accounted for 45%. So that is more or less business as usual. We did see a bit of uptick in China, but whether that's a trend is far too early to say.

Looking into Molecular Tools. We had quarterly sales of NOK 14.6 million, accounting for 55% of total Q2 sales. As I mentioned during the Q1 presentation, we had a large order coming in, in Q1 which is also why Q1 was particularly good. Next slide, Borge. Looking at biomanufacturing. We have quarterly sales of approximately NOK 12 million, a slight improvement from Q1. We saw a bit more orders coming in from the U.S. East Coast than the previous quarter. And we also saw that SAN HQ GMP sales was slowly starting to pick up in the Q2 proportion of sales.

Looking at total orders. As I mentioned, we had a record all-time high of just short of 400 orders for the quarter, and I'm encouraged by this. So even though it is a very challenging market environment we are bringing in, we are still managing to get our products out in the hands of customers. We're planting seeds for the future that is going to lead to growth. It is, of course, driven by smaller value orders. So the average order size value is down, but there is activity which I am very pleased about. Next slide, Borge. Then I want to go into biomanufacturing in a bit more detail. I want to take you through about our thinking, how we're working with ensuring that we are going to be successful with growing this segment long term. First of all, you have to have a product that solves customer pain points. We have that with SAN HQ GMP. We have a lot of positive response from customers on not just SAN HQ GMP, but also especially on M-SAN and what M-SAN can do for their manufacturing process. We're going to launch new AI-generated versions of SAN to our partnership with Biomatter. And we are already now working on a project where we're looking into enzymes for advanced therapies. So the future is already being planned.

Regulatory compliance, GMP grade is a given, we need to have nucleases with produced according to GMP, and we also need long term on our nucleases. We're working on that, as mentioned. And within the next 12 months, we're going to have new GMP-grade enzymes on the market.

Another important element in our penetration of the market is to ensure that we have the right application data. We have the right competitive data and that we also have publications and patents. We've made progress within all of those areas during the past third quarter. We have filed two patents during Q2, one on the application of our nucleases and another one on RNA enzymes. And we have also progressed significantly with our partnership with acib where we have generated new data that's going to be presented September 19 [indiscernible].

In regards to the value proposition, we have a strong value proposition. We're going to continue to strengthen that to ensure that we have all the tangible benefits of switching to SAN laid out. Then the last point, that's the go-to-market decision, which is, of course, also extremely important. We, as mentioned, sell more than 90% of our enzymes through our own channels. We believe that a distribution partnership is a viable way to go to ensure that we improve our reach to the market. So all these elements put together executing on these parameters is going to lead to long-term growth and further penetration of the biomanufacturing market.

I want to provide you with a bit more detail in regards to our thinking in regards to distribution agreement. So what we are talking about is an OEM agreement. And by that, we mean that we're going to work together with a partner and that partner is going to sell one of our SAN nucleases under their own brand. So that's an OEM partnership agreement, which we are currently talking about. If we look at the reasoning behind looking into a distribution agreement, then we are historically an OEM company, meaning that we have limited reach. We work together with larger partners. We supply them with a component that is typically put into their process or their products. We have identified a number of potential companies, larger companies within the life science space that work within the cell and gene therapy area, but do not have a salt-active nuclease.

So we have reached out to them and the whole idea behind it, of course, is to create a win-win situation where ArcticZymes gets market penetration and share for SAN and the partner gets a more complete portfolio to offer its viral therapy customers. In regards to progress, then we have made significant progress. We have three partners that we're working with, talking to two partners have made significant progress. The requirement is that it is -- it has to be a GMP-grade nuclease. Partner one have tested a nuclease and the next step is to go into further discussions in regards to time line and potential deal scenarios. Partner two have already tested. They have taken the enzyme into their accelerated product development plans, which we are now part of. And their initial goal is to try to launch an OEM version of SAN in Q2 next year.

What you have to be aware of is that we are currently talking to a Fortune 500 company, and they do their due diligence thoroughly which is also extremely important for us because we want to have a partner that's committed. We want to have a partner where this fits into their strategy, their portfolio in order for us to ensure that we get the attention that we need and that it's also, of course, going to lead to volume growth for our products. We are not looking for a partnership where we're just going to become another catalog products. So we expect that we are going to be able to -- or anticipate that we're going to be able to reach an agreement within the end of the year. And we expect that it is going to have a positive effect of our SAN sales during 2025 and also a positive increase of our ELISA kit sales, of course. And all in all, just give us an increased penetration of the CDMO and biopharma market. So I'm really excited about this development because it really shows that our product performs. It shows that our product is competitive because these companies have tested our nuclease up against the competition and decided to continue the talks with us. So great development. Next slide, Borge. Partnerships with CDMOs is also extremely important for us. And also within this area, we have made progress in the quarter. The end goal is to become part of a CDMOs platform. Every CDMO out there within this space has a platform. So that's basically their manufacturing recipe -- their validated manufacturing recipe that they sell to their customer. This is what we are going to use if we are going to supply you with a viral vector of high quality and high yield. We are in close talks with one of the leading CDMOs within the cell and gene therapy space. They have said that they want to integrate our nuclease in their platform. And it's going to be their standard nuclease that's going to be applied in all new projects coming in at the CDMO. So we can expect a gradual ramp-up of revenue at this partner CDMO as soon as it's integrated in their platform. Also very exciting and also really, really a validation of our products. A statement from the VP of their process development on the performance of our nuclease was, your product is almost too good to be true. With our product, our nuclease, they have been able to take out one full nuclease step. Previously, they ran two nuclease steps. With ours, they only have to run one. So I think that speaks loud and it's really a testimonial of what our nucleases are capable of doing. Next slide, Borge. And now I'm going to hand it over to you, Borge, to take us through the finances for the quarter.

[Børge Sørvoll, executive]

Thank you for that introduction, Michael, and a great summary of all the activities that's been going on during the second quarter this year. I will now take you through some slides on our expenses and the profitability development over the last quarter. And it is, as I stated in the first quarter, our ambition has been now to ease up on the throttle and reduce the spend moving forward. However, this doesn't mean that we will stop with kind of investments we are doing, but we are not ramping up the organization and expanding the team beyond where we are today moving forward now.

Looking at the financials for the second quarter and the first six months of the year. Sales has, as Michael said, been challenging, but I can say that we have good control on our cost and also looking at the financial figures. Our revenues ended up on NOK 27.5 million. It's a slight decrease from the same period last year, but is also that our revenues in this quarter was also positively impacted by revenues related to the grant we were awarded in the second quarter this year by the Research Council of NOK 1 million, as you can see. Cost of materials is slightly higher than previous quarters due to the fact that we had to dispose some ELISA kits from our inventory that expired. And this is something that I will also talk a little bit more about in the next slide coming up now.

Personnel expenses slightly lower than the same period last year with NOK 12.9 million versus NOK 13.1 million in the same period last year. Capitalization of project and personnel expense is something that we have experienced through a larger degree over the last few years and in the second quarter this year, we capitalized NOK 2 million on projects, whereas NOK 1.2 million of this is related to personnel.

In the same period last year, NOK 1.3 million was capitalized of personnel expenses. You can also see that personnel expenses are lower in the second quarter compared to both Q1, Q3 and Q4, and that is due to holiday pay in Norway. So we basically have personnel expenses for two out of three months in the quarter. That's why it's lower in Q2 compared to other quarters. Our other operating expenses are slightly higher this quarter with NOK 10 million compared to NOK 7.4 million at the same time last year. And the main difference in expenses are primarily explained by expenses related to the ERP project of NOK 1.4 million in the second quarter and you can see that there is a currency conversion also that impacts the numbers.

Last year, we had a gain of NOK 0.6 million in the quarter, meaning our expenses were reduced by 0.6. And this quarter, our expenses were increased by NOK 0.1 million due to the currency changes. Our second quarter EBITDA ended up on NOK 2.6 million versus NOK 6.9 million (sic) NOK 6.8 million in the same period last year, but there are, however, some extraordinary items in both Q1 and Q2 that impacts underlying results and comparison, and I will talk a little bit more about that in the next slide.

For the first six months, revenues are at NOK 57.6 million versus NOK 59.4 million in the same period last year which is a reduction of NOK 1.8 million or just a 3% decline. Some expenses for the period are at NOK 52.7 million versus NOK 46.5 million (sic) NOK 46.4 million or an increase of 14%. And the majority of this increase is related to extraordinary items, such as the ERP project that I talked about, which is planned to be completed in the fourth quarter this year.

You can also see on the graph on the left-hand side that our EBITDA margin is slightly improved compared to the last -- previous two quarters with 10% margin this quarter compared to 7% and 8% in both Q4 and Q1 -- Q4 last year and Q1 this year. Also as I talked about in the previous slide in the first quarter presentation, there are some extraordinary items that are impacted both quarters here. In the second quarter, we had to expense NOK 0.6 million related to disposal of ELISA kits, which are produced by a third party supplier. And basically, 2024 is the first year ever where we had to dispose some of our inventory due to expiration of shelf life. Actions have been initiated to avoid similar situations moving forward where we are looking at extending the shelf life of the kits, and this is being done through internal stabilization studies and to improve the documentation that we have on the products here. We also expensed NOK 1.4 million related to implementation of our new ERP solution. And as I talked about in the first quarter, this is a project that is expected to be finalized in the second half of 2024. And the ERP investment is a key project in 2024 as our current solution is more or less outdated. And the new solution will also ensure that a more forward-looking platform incorporating new tools and efficient ways of conducting our business.

We would also ensure that we can scale up the business when we see proper growth in the underlying business here. When eliminating extraordinary items this quarter, adjusted EBITDA for this year would be NOK 4.6 million -- or for this quarter would be NOK 4.6 million compared to NOK 6.9 million in the same period last year which is a reduction of NOK 2.3 million.

The cash and cash balance, looking at the changes in cash, we had a negative change in cash of NOK 1.7 million, and this is primarily influenced by changes in accounts receivable, where receivables have gone up by close to NOK 8 million from the fourth quarter last year, but we have also reduced our payables by close to NOK 5.7 million. And both of these two has, of course, an impact on our cash flow from a temporary point of view.

For end of the quarter, our cash position was in excess of NOK 170 million. And as I mentioned in the fourth quarter and first quarter presentation, due to technical reasons, we had to reclassify some of our investments in low-risk interest rate funds to other assets. And in the past, we call them cash equivalents. And of course, this impacted our cash position by an estimated NOK 71 million but it does not have an impact on our available liquid funds in case there should be a need for cash.

And with the cash and short-term investment position of close to NOK 240 million per end of the quarter. I think I will hand it over to Michael now to give us a final detail on what we expect.

[Michael Akoh, executive]

Thank you, Borge for taking us through the finances. The outlook is that long-term market fundamentals are intact. There is a significant number of new drug approvals, especially within the cell and gene therapy area, indicating that there is going to be growth of the use of nucleases going forward, positioning our SAN portfolio nicely. In terms of important inflection points going forward, then partnership deals, both within CDMO as well as distribution partnership agreement are important to grow value revenue growth going forward. Within the next 12 months, as mentioned, we're going to have two new GMP-grade nucleases launched alongside with one ELISA kit. And that is going to provide ArcticZymes with what I would say is probably the strongest nuclease portfolio on the market. So we are going to be extremely well positioned for growth going forward. So we're going to continue to execute on our strategy, become more market driven, strengthen our portfolio and look for partnership deals throughout the value chain. And with that, I would like to thank you for your attention and open up for the Q&A session.

[Børge Sørvoll, executive]

All right, Michael. I will ask -- we have a few questions here online here. Are the increased number of orders relating to a pickup in evaluation orders from customer. If so, any early feedback and any signals when this can be converted to larger orders?

[Michael Akoh, executive]

For the quarter, we had approximately 43 so-called evaluation orders. And talking about signals from Q2 is maybe a bit early. We, in general, have received positive feedback. But I think what is important to state in regards to the pickup for the all-time high orders that we have in Q2 is that it is an indication of continued interest, continued activity, both within Molecular Tools and within biomanufacturing. But it's too premature to say that this is general momentum. We need to look at more quarters to actually see if this is a trend.

[Børge Sørvoll, executive]

Is it possible to share some expectations on the magnitude of our CDMO supply agreement in relation to the current biomanufacturing revenues you have?

[Michael Akoh, executive]

It's premature to share figures on that. But both in regards to the OEM distribution agreement as well as the CDMO agreement, it is a gradual pickup. We're going to have to invest especially in the distribution agreement to get the partner up and running, get their staff trained, well equipped to go out and have the customer conversations that are needed to convert things into sales. But it is, of course, something that I expect is going to be a major sales volume driver in the future. And that's why it is so important for us.

[Børge Sørvoll, executive]

Do CDMOs normally decide what nucleases customers use in their manufacturing processes or is it the CDMO customer who decides?

[Michael Akoh, executive]

I'm not an expert on this, but based on my discussions with CDMOs during the past quarters, then it is always the goal of the CDMO to ensure that their platform is used. That's what they're comfortable with, that's what they can ensure successful. So in the majority of cases, it is going to be the CDMO's platform that is applied on customer projects. There are, of course, exceptions to the rule. But normally, when a client comes to a CDMO within the cell and gene therapy space, they come to them because they are the manufacturing experts. And therefore, they would also most likely in most of the cases, apply the standard platform that the CDMO is using and is recommending to be used. So the answer is yes.

[Børge Sørvoll, executive]

Thank you, Michael. We don't have any further questions right now. So I think with that, we thank all -- everyone for listening in, and thank you for watching this Q2 presentation from ArcticZymes Technologies. And we wish you all a great day. Thank you.