Hey, och varmt välkomna tillbaka till DNB Carnegie. Vi fortsätter med våran Micro Cap Healthcare-dagen och vi tar faktiskt nästa presentation på engelska också. Please, Anders Månsson, welcome. We're going to talk about Iconovo. We just remind you of the format. You will first give us a presentation about what you do and what your future may look like. We will continue with some Q&A. I encourage everyone to ask some questions in the chat. I will make sure to be on the lookout for questions that may come in here. For now, please, Anders, take it away.
Thank you so much. Thank you for the kind introduction. It's my pleasure today to talk about Iconovo. Of course, Iconovo is a company that has its base in inhaled medicine. Of course, that is most often applied for respiratory disease. As I will allude to later in the presentation, it has a growing area of interest also for other therapy areas where it can be used to replace injections for vaccines and for therapeutics. Perhaps first, a few words of introduction to myself. My name is Anders Månsson. I am at the helm of Iconovo since November of last year. In terms of introduction, educational background, I've got a business degree from Lund University in Sweden, and on top of that, an MBA from IMD Business School, Lausanne, Switzerland. I have a vast experience in terms of international experience.
I work for global pharmaceutical companies, as well as for smaller development-focused companies, both in pharma, in med tech, and in biotech. I've also worked in consultancy and in the financial sector that surrounds our industry. I have particular strengths in marketing, in mergers and acquisitions, in licensing, and also in commercial operations and finance. I will devote about 50% of my time to business development in Iconovo. Moving our focus then to the company itself, we have a mission that is to accelerate access to innovative inhalation medicines. We do that in two aspects. We do develop generic versions of inhalation medicines for respiratory diseases, we also increasingly focus on new and reformulation of drugs that are typically available only in injection form for use in any therapy area, bringing superior patient convenience.
Obviously, if something is available only in injection form, we can add patient convenience by adding an inhalation form. We rest on a few core competencies. We have, through technical competency, developed five inhalation platforms, and we have know-how around these, and we continuously adapt on these. We do have drug development competencies that allows us to develop dry powder inhalation formulation of medicine, and we have the analytical capabilities that allow us to guide the development of pharmaceuticals step by step. All in all, we suggest that we have leading development capabilities in inhalation medicine. Looking at this through the lens of business models and partner categories, as I alluded to, we do develop respiratory inhaler generics. Essentially, we have two products there. One is a copy of AstraZeneca's Turbuhaler, and the other one is a copy of GSK's Ellipta.
Obviously, with those development projects, we work with generic companies. We also have a resting generic company ourself, which is called Iconovo Pharma. The idea with this company is to market our own generics in the Nordics when these products reach the markets. As I also alluded to before, we do have inhalation formulation in any therapy area, and there we work in two subcategories. One is differentiated generics, where we work with off-patent APIs, active pharmaceutical ingredients, and we invest our own money into starting these development projects, and then we try to license these development projects to companies that work with generics.
The other branch is that we work on differentiated originals, where we have original APIs, active pharmaceutical ingredients, and we work in coalition or together with innovators in that area to produce innovation in terms of the administration form of an existing API. As I've alluded to a few times already, there is an imminent paradigm shift in inhalation medicine going beyond only respiratory disease and moving on to biologics. As I will comment on later in the presentation, there are many high sales biologics that are impossible or notoriously difficult, at least, to develop into oral formulations, which are preferable to patients. If you look at these various formulations here, you've got inhalation, which is something that is patient friendly, and you can also work on biologics with them.
Tablets, obviously patient friendly, but very often you cannot formulate an oral formulation with larger molecules. Injections, not at all patient friendly. Many patients fear injections, but obviously, if you shoot something directly into the bloodstream, you can also work with larger molecules. Inhalation essentially has both of these benefits, if you compare it to tablets and injections. Moving further into our business model and looking at our investment model, we typically work at the early stages of development ourselves, where we invest money into building the platform that we have built in terms of the inhalers themselves, but we also work on developing the formulations that fit these inhalers.
We try to find a license partner, commercial license partner, prior to reaching the later stages of development, where investments are needed into clinical trials and also the setting up of commercial manufacturing. In doing these sorts of licensing agreements, we aspire to have a break-even situation prior to going into clinical operations. Of course, the idea is that the partner would then come in, pay us an upfront payment, pay milestone payments for the ongoing development, so that we reach this break even, and then we can choose either to invest or not to invest in the later stages of development. The partner will essentially pay the bulk at any rate, and then we get royalty income from the markets that the partner will take.
In most cases, that is global rights, or in the cases of generics, we like to retain the rights in the Nordics at least, for Iconovo Pharma, as we alluded to before. Essentially, we let the partner finance the later stages of development only to score the royalties from other markets and to have direct sales in the Nordic markets. There are a few external factors that I think are of importance to both of our areas.
One important external factor, as regards the generic side of our business is that there is a new simplified process for reaching the market with inhaled generics. That is the fact that the FDA has retracted their previous demand for pharmacodynamic studies, essentially clinical efficacy studies, and now settle only for PK studies or pharmacokinetic studies, where we essentially measure the levels of the drug in the bloodstream. This is very important because this removes the most expensive part of the development process, and perhaps even more significantly, it cuts time to market, which is, of course, of great importance to us, as that makes our generic projects so much more attractive to partners.
There is also an important external factor in our second area, which is reformulation, and that is the fact that there is an enormous, an enormously attractive, I'd say, from our perspective, pharma patent cliff in the next 10 years or so, where a lot of what we consider new products today will go off patent. A lot of these products are biologic products with large molecules that are, as I said, notoriously difficult or even impossible to formulate as an oral formulation. Going forward, Iconovo will focus more on biologics and other reformulation areas, and that is a journey that we've already started with semaglutide, which is the active ingredient in Ozempic. Let's have a look at the entire range of inhalers that we have available at Iconovo. Starting to the left, we have ICOres and ICOpre.
These are two generically directed inhalers. One is a copy of AstraZeneca's Turbuhaler, and the other one is a copy of GSK's Ellipta, which carries a lot of respiratory products. Those are two products that are currently in a structured licensing process. We have ICOcap, which is a capsule-based inhaler. Essentially you insert the capsule and you're able to click and make the drug available for inhalation. This can also be used in a generic setting, but it is a very versatile multi-dose inhaler, so that can also be used for reformulation and new formulation purposes. To the right we have the two ICOone and ICOone Nasal. One is a pulmonary inhaler and one is a nasal inhaler.
These are one-time use inhalers that obviously are very attractive in terms of when you have not daily use of the inhaler, but perhaps for a vaccination, perhaps there's some drugs that you don't take every day. They can, of course, be used every day too, but the inhaler is a throwaway inhaler, so you take a sniff and then you discard the inhaler and you get a new one for the next dosing. I'd like to emphasize that we also work on adaptable design depending on what the indication of the drug is. Some drug categories are, of course, perceived as more lifestyle-oriented. We also have the ability to produce our inhalers in a more sort of lifestyle-oriented design, as you can see to the right here.
Whereas we have this platform of five inhalers, that is the archetypical version of them, but we're able to adapt them to different needs. The advantages obviously remain the same, patient preference in terms of comparison to injections and a rapid onset of action in comparison to tablets, if tablets are at all available. Summarizing and repeating a bit, what is the vision for Iconovo's corporate development? It is to build a company going from a platform-based company where we have a technological platform and intrinsic know-how to the inhalation business, and we license through partners, going to spanning the full capacity of the value chain, having marketing and sales operations also in the Nordic European area, and also managing commercial supply of the inhalers themselves.
We want to expand from being a platform-based, licensing-dependent company to actually span across the value chain to become a fully fledged pharmaceutical company. Just a few words on our pipeline. Obviously, we have a lot of projects in our pipeline, although most of these projects are in the early phases, and obviously you need a lot of projects in the early phases as there is some attrition to going towards licensing. We have a few pipeline projects that I would like to highlight. One is the ICOres copy of Turbuhaler, which we have licensed to Amneal previously, but we're now searching for a European partner, and that process is ongoing and hopefully will come to fruition in the near-term future.
We've also just started a structured process to license ICOpre for the GSK portfolio of products, and that process we deem will reach an end at least by the end of this year, if not before. We have a lot of ongoing minor projects, and perhaps one more project should be highlighted, and that is the semaglutide project or the inhaled version of Ozempic project. That is something that we're investing in currently. That project is currently in preclinical operations, but that is also something that will come to fruition. By the end of the year, we will reach a preclinical proof of concept, and that is the point at which we would like to license this project. Let's go deeper into some of these projects. We have two imminent licensing opportunities.
One is the copy of AstraZeneca's Symbicort Turbuhaler. That has access to a $3 billion US dollar market globally, and that market is still growing. On the other side, we have the GSK copy of Ellipta. The Trelegy and Relvar being the number one and number two asthma products. Asthma and COPD products, actually. That market address is about $6 billion US dollars and also still growing. Highlighting again the semaglutide project. Again, the active ingredient in Ozempic. Here we have an interesting view to this market. Obviously, we all know that obesity is the most potent risk factor for type 2 diabetes. An injected GLP-1, as this group of products is called, has revolutionized this treatment.
We suggest that ICOone Nasal could be something that provides a more patient-friendly option to injections and an option for those patients who don't prefer tablets, because there are lots of restrictions around the tablets. This market is forecasted to reach EUR 100 billion in 2030, so it's a humongous market, and we certainly aim to license after preclinical proof of concept, as I alluded to before. Just to provide you an example of how this switch to inhalation can work, there is a good benchmark here in glucagon, which was introduced in nasal formulation in 2019. Now, five years later, than that, or two- years ago, it was five- years later, we do have a market share of 50% of that market while the market has kept on growing.
When I say we, I don't mean we Iconovo. It's not our product, but this is the benchmark that we use in order to attract partners, suggesting that this is a viable option. Digging deeper into the semaglutide perspectives here, we are developing a broad-based IP structure around inhalable semaglutide and the drug device combination with our inhaler. We do this in collaboration with Lonza, a very large global CDMO player. As you might have noticed if you follow Iconovo, we have just signed an LOI, a letter of intent to engage in a deeper, a more expanded collaboration on a strategic level with Lonza. We have a first preclinical study on semaglutide in operation. As I alluded to you already before, this market is quite huge, EUR 100 billion.
Summarizing our priorities in 2026, we want to extend the partnership that we already have with Amneal on ICOres with a European partner and possibly some other rest of the world markets. We do this in collaboration with Amneal, and we wanna keep the Nordics for Iconovo Pharma AB. Then we want to enter into a global partnership on ICOpre, keep Northern Europe for ourselves, and of course, keep inhaler manufacturing rights. We want to enter into a partnership on ICOone Nasal on semaglutide. Obviously, these are three very important objectives. They're quite possible to accomplish in 2026, but even just reaching one of these objectives for 2026 would be transformational for the company.
In the longer run, in the longer term, we have a greater focus on the reformulation business, especially on biologics, because of the inability to produce patient-friendly formulation for a lot of these products. How do we do this? We've decreased our burn rate. We have much more external focus, which is valid for the company at large. We are introducing more creative businessmanship to the company. Business development is very much the art of what is practically possible. If we're successful in one instance, that success will translate into success in other areas. We're looking for flexible solutions on funding and collaboration, and the LOI that we just signed with Lonza is one example of this. We're taking an increased responsibility for sourcing and manufacturing.
We would like to take the responsibility for commercial manufacturing and supply of the inhalers per se, going forward. This requires a bit of courage, a bit of patience, obviously, but we focus on the long-term value creation since the markets that we address are so humongous. We are today a platform-based company, but we want to develop into a pharmaceutical company, and we certainly have some good benchmarks for that in our vicinity in Lund where we're based, in the companies like BONESUPPORT and Camurus, who have successfully developed from being a technology platform-based company into a fully fledged commercial company with tremendous value increase as a result of that. Summarizing the presentation, there's a new Chief Executive Officer on board. I have significant business development background and experience.
We want to grow the company from being a technology platform-based company to span the full value chain. We do have some interesting new external opportunities. We have a simplified process since only last year for respiratory generics with huge global sales potential, and inhaled biologics is a new area with an even bigger global sales potential, so that's highly interesting for us as an inhaler-based company. We have strong and competent major shareholders in Färna Invest and Fåhraeus Startup and Growth Fund, which is, of course, of crucial importance in these times. Our business models offer scalability between risk and reward and fee for service, and Iconovo has a lot of different projects, so we're certainly not a one-trick pony. I'd like to use a very popular phrase in saying thank you for your attention to this matter. Thank you.
I was just about to chuckle about that last phrase, very, very thematic in this last month. Thank you very much, Anders. I was thinking we will start with a question about the future and about the past a little bit as well. You've been on board since November, and a lot of the messaging in your presentations and when we talk is that it's been sort of a new start for Iconovo. Could you maybe summarize what are the biggest changes in how the company operated, say, a year ago towards now?
A year ago, in comparison to now, the company was still building its technology platform in terms of the actual inhalers. We're very satisfied with the five inhalers that we have currently, so we've sort of decreased efforts in scaling that. Instead, we focus much more on the projects, and typically, a lot of the projects that we operate on in early stage we also charge for. That is also an important distinction, I think.
Mm-hmm. You have mentioned when we talked about the pipeline, you've mentioned structured licensing processes. Could you please elaborate what that might mean?
Yeah. We're working together with a broker company called, Alira Health-
Mm.
They're handling the processes, trying to get as many potential, licensees in on the same process, so that the process becomes as competitive as possible. We have an aim to come to fruition, come to conclusion on these processes, during the course of this year.
All right. You have mentioned support from Fåhraeus Group and from Färna, and you recently raised some capital. My question here would maybe be what are the objectives, what were you gonna use that cash for, and what milestones do you aim to achieve with that money? Maybe what is the cash runway.
Yeah
I n simple terms?
The cash runway is as almost always at least a year of runway. Hopefully, and certainly our aspiration if we do one of these deals, or several of these deals, that will also bring cash to the company. The sort of long-term aspiration is that the company will, to a larger extent, fund itself going forward. That is certainly a long-term aspiration. Of course, in a matter of years when our first projects can actually hit the market, royalty revenue will also be sufficient to make a decent profit.
If, I know this maybe is a, an impossible question for a ceo, but out of your projects, what do you see as the most important value driver? If you could maybe rank them?
Well, value driver, I suppose, initially is that we have the competency to do this in an area that is, well, maybe booming is too big a word, but it's certainly expanding, and the interest is certainly there. Not in the least with the change, the paradigmatic change, as I described, in the biologics area. A lot of these biologic product patents are coming to an end in the next 10 years. Typically when that happens, there is typically new formulations being developed, and tablets is would be the obvious choice to go for. The problem is that these large molecules are not suitable for oral formulations because the gastrointestinal tract is basically programmed to break down this sort of molecule.
Inhalation provides sort of an escape here, whereas we're able to provide something that actually reaches the bloodstream to a large extent, while also being very patient friendly because very few patients would mind taking a nasal sniff, for example.
Yes. That is so. I'd like to end with a question that I've answered other companies here. If we were to meet here in five years time, what would have happened to Iconovo? What do you feel that you can achieve in five or six or seven, in the longer term?
Yeah. I think some of the projects that we currently have in the pipeline would certainly be on the market, and we would be collecting revenue from these markets and also operating on sales and marketing operations in the Nordics or Northern Europe perhaps even. The collaboration with Lonza, I think, is also an important one that can lead to expanded business development efforts but also to support the efforts that we're currently starting in biologics. Yeah, a positive cash flow or very significant strategic investments on the basis of the cash that we can generate. In the long term, I think value creation is key.
Thank you very much, Anders, thank you for everyone listening to us.