Move to the agenda. I will flip to Slide number 3. Here you can see what we will go through today. Please bear in mind that all presenters are real time today Nothing is prerecorded. If we have some gaps, then you know why it is.
For example, during a live tour, where we will go through 4 sections. We will have 3 camera teams shooting that event. On the live tour, we will look at research and development, quality control, pharmaceutical development and GMP Manufacturing. We will start with our CEO, Edward Ekstrom. Following that, our Chairman of the Board, Miguel Collado.
After Leito, some commercial aspects and the entire team. We have a guest speaker today, Mike Ria, our Strategic Innovation Advisor. Welcome to you too, Mike. We will continue with Biologics, AI and finally with some finance. In the end, we have the Q and A.
I please ask everybody to save the questions till the Q and A, and we will take them all there in one go. With these words, our Founder, Professor, CEO, Edward Hechtel, please.
Hello. Also from my side, warmly welcome and much appreciate that you take your time And give it to us. I would like to start by saying that everything we do, We set out from the patient perspective. So, patients first. Then, of course, today, Capital Markets Today, if I have understood it correctly, it's about a show.
It's about education and it's also hopefully to provide some insight. So, these things are on the top of my mind when we set out. And once again, thank you for joining and let's have some fun today. Next slide, please. So if we take a look at the slide, in the southeast corner, Which is much, much larger than what we had 1 year ago.
And I am very much a person who looks at deltas. So how did we reach that one? Of course, we have muscled up and polished the organization. We grow, we serve and we become stronger every day. Next slide, please.
Here you can see to the left the situation a year ago and to the right the situation today. This is my scoreboard. This is my operational palette. This is what I'm working on. Here we can see a big pharma, we can see midsized and specialty pharma, we can see biotechs And we can also see collaborations.
Let me spend a little bit time on the collaborations, which is a new class. These collaborations are with other tech parties and we do them in order to create synergies, 1 +1equals3. So together, we can serve API owners and API parties better. That's why we do them. Next slide, please.
Here you can see to the left the situation a year ago and to the right the situation now. In order to spread The evangelium of nanoforming, how important it is for the industry and for the patients. We need to have people talking. Today, Christian and his teams are going to take you on this tour. So as you can see, we have put a lot of effort into this and we will continue to do so.
It's important to us and it's important to others. Next slide, please. Here you can see our business targets for 2025. Let me start with what has not changed. What has not changed is we will be cash flow positive.
What has not changed is we will achieve 90% gross margin. What has changed is we will run through the machine more APIs per year, up 40%. In order to do that, we will require more lines and as you can see also up 40%. We will also mathematically increase our productivity Because we will achieve this 40% increases, you are seeing something between 0% 25% more employees. So, more APIs through the machine in order to be able to show to the world and to the patients what nanofarming can do for them.
Next slide, please. I switch gears. It is my great pleasure to introduce my boss and my mentor, Miguel Collado. He is a man who has seen a lot, Harvard educated, a lot of time in the pharma industry And also a lot of other things, motorbikes, airplanes, you name it. I have found a guy who is faster than me, Who is smarter than me and most importantly, a guy I like to work with.
So Miguel, please.
Well, thanks for your Nice words, Edward. And once again, welcome and thanks for joining us. So I'll use the next few minutes just to focus on 2 topics. The first one is why Nanoform, why I joined the Board of Nanoform and then the second one about the role of the Nanoform's Board going forward. But before doing that, let me spend a few words on myself and my background.
So I was born and raised in Portugal. But as a teenager, I left to Brazil and was in Brazil At the Qatar University, I finished my degree in Business Administration, although later on, I graduated from Harvard Business School. I started my professional career at the division of General Electric as a CFO for Brazil. Then for 15 years, I was with PepsiCo, first as a CFO for Latin America based in Rio and then later on in Buenos Aires. And then I was the CFO for Asia and Pacific out of Hong Kong.
And the last 5 years at Pepsi, See, I was the CFO for all the international business based in New York, USA. I moved to the U. S. In 1992, And then I became a U. S.
Citizen. The 10 years after that, I was at Dean Foods, which is on the large Food company in the U. S, and I was their CFO for the International Business and Executive Vice President for the company. But in the last 15 years, I was in I am in the Pharma business. The 1st 13 years with Avian, which is a leading CMO with significant expertise on spray drying and the last 2 years with Nanoform.
And this brings me to the first topic of today, why Nanophore, why I joined the Board. So at Avion, I had hands on experience on the importance of particle sizing On the development of new drugs, the improvement of the current ones and the overall success of pharma. Because NanoFront technology takes particle sizing into a totally new level. Not only can achieve Particle sizings that no one else can achieve, but more importantly, has proprietary technology. The IP that Nanoform has gives Nanoform a great and clear competitive advantage going forward.
The second reason that I am part of Nanoform was due to the people. So I met Edward, I met Albert, I met other founders, And I was very impressed with the caliber of the whole team, their knowledge, their teamwork, their valeries And their attitude and motivation to the business. So in my old standards, there's a quite impressive team. So overall, if you ask me, would I join the Board of Nanoform again? Absolutely.
So that brings me to the second topic of the day, which is the Board of Nanophore. Now Just a parenthesis here. Based on my experience, not only as a manager being part of the Board As a VP or as a management part, but also as a board member of publicly traded companies. I think there are 4 areas, It's called 4 pillars that I think makes to a high performing Board. The first one is governance.
We want to be a higher quality and effective Board with very strong governments, not only with the right mix Skills in terms of people and then the clear functioning of our committees, audit and compensation. But we also want to adopt the best practice on issues that are relevant to all stakeholders, Talking about issues like ESG, areas like diversity and inclusion. And a very important one that making sure that we have robust risk management processes. The second pillar area related to the Board is strategy. I think it's The Board's responsibility to ensure that the Nanoform has a well supported And well articulated business strategy that have clear goals and milestones.
And it is also our responsibility to ensure That all management actions and capital allocation is done in a way that is consistent with our overall strategy. And this brings me to the 3rd pillar, which is people. You can have the best strategy, but if you don't execute it well, Which means if you don't have the right people, it's maybe worthless. So people and people management, I think, is a key Priority for the management and for the Board. It's important that we have the right human resources processes, Not only hiring the best people, but just making sure that we have the right training and development programs, That we have a solid succession plan with specific focus on our senior team, but very importantly That we have a compensation system that is well aligned with the strategic goals, the company performance and more important, that promotes Good behavior.
And that finally, that brings me to the last item, which I think is measured has a major importance On the functioning of the Board. I'm talking about ongoing support to the CEO and senior management. So we meet formally, most of the time face to face, Not recently because of the current situation. We meet 10 times a year. So the committees do the same.
But every Friday, every afternoon on Friday, Edward and I talk over the phone. I will discuss any item that I, Edward or myself, feel that are relevant. And I think these conversations are very important because It helps our understanding and hopes us to solve any business issues that we think is important To address early and should not wait for the Board meeting. So overall, I think we have the basis for having a high performing board, as I call it, right? So In summary, I think I gave you a sense of who I am, why I'm here and what are the goals going forward.
So with that, thank you for listening and the conversation back to Eduardo.
Welcome back. And I want to show you where we are and what it looks like at our facilities. Over to the left on my side, you can see the biggest pharma campus in Finland, that's in Viki Outside Helsinki, 15 minutes from the Helsinki International Airport in Finland. We are just outside on the other side of the road. And as you can see, even the government likes us.
They have here invested A lot of money in a fast rail truck that's going to go right outside our house and it will serve us well. Then I move over to the right side of myself, and I would like to introduce to you our house. On the first floor, we have the GMP floor to the left, GMP 2, 3 being constructed to the right, GMP 12. As you can see, we have a construction going on here at the same time we are speaking. On the second floor, you can see a formulation where we Basically create intermediates.
And on the right hand side sorry, on the left hand side on the second floor, we can see more of the formulation people And there is also going to be parts of the GMP 2, 3 lines that protrude through the floors. To the left on me, on the 3rd floor, we see finance. And then on the right hand side, on the 3rd floor, We basically see QC and all these functions. And we're also going to go there today. So this is our house 15 minutes from the Helsinki National Airport, which is 6 hours from Boston, at least with tailwinds.
And now, it's my great pleasure to introduce to you the guy who has maybe the toughest job in the company, Professor Niklas Sandler, who is our CTO, it's really, really hard to lead a technology that's being developed Both technically and commercially at the same time. So over to Niklas and let's have some fun.
Thank you, Edward, and welcome to the R and D laboratories here at NanoFoam. These labs are hosting some of our SES Lines for small molecules. So I'm Niklas Sandler. I'm the Chief Technology Officer of Nanoform. I was intrigued and excited to join Nanopharm 2.5 years ago due to the fact that this is a unique opportunity To take a new technology to the market and with this technology, provide future therapies using nanotechnology.
My background is in pharmaceutical technology. Before joining Nanoform, I was Professor of Pharmaceutical Technology At Aurovo Academy University Finland. And I've also worked in the industry with particle engineering, material science And Pharmaceutical Manufacturing Technologies. So the R and D Labs today host 11 R and D or non GMP lines on the small molecule side and then 2 lines on the biologics side. Obviously, as you saw in the new targets, we are will be busy the coming years as well, increasing the capability On both the small molecule and biologics side, we have been growing Fast.
As you saw in the numbers, also in the R and D sector, we have doubled the amount of Staff and we're really happy to be able to really attract talent to the labs. You will see during the tour that we have been able to boost up the formulation capabilities And the instrument part for quality control as well. 1 of the biggest Endeavors that we have during the years and the years to come and currently is to really be on the edge of the technology development All the time, and we're investing, of course, heavily on that. For instance, by Implementing automation and increasing our process control capabilities. But let's go into the labs.
I will show you around a little bit, so let's enter the lab. And as I said, this Laboratories hosts SESLIGES. Actually, this facility here hosts 3 lines altogether. Today, we have 2 of our process engineers here, Thomas Pura and Gjerne Naval, who will demonstrate the SES Process line in action.
Okay. So welcome. I'm Juan, R and D engineer here. Let's start from our OLED supply. So here we have 2 cylinders Liquids 2, then we pull it down for more efficient pumping.
After that, Here we have the pipe cracker pump under the table, which then pressurizes The CO2 of several 100 bars and so it enters the supercritical phase. Then the supercritical CO2 enters the Salvation pressure vessel here in the fume hood where we have the API inside. So there, The supercritical carbon dioxide results, the API and after which we then control the expansion of Supercritical Solution, and there at the nozzle on the top of the collection vessel, we then get API nanoparticles, which are then encapsulated in the dry ice, which is also formed by the supercritical carbon dioxide. And Then a few words about our Process Control. So here we have the Process Control software.
So it is our custom Software to control the test process. So it reads all the sensors. It controls all the equipment, so the pumps, the thermostats And the valves and after the process, it stores all the data to the cloud for further analysis.
Thank you very much. And this is a demonstration of one line. And As you appreciate, we have the capability of serving many customer projects here. 1 of the greatest successes from last year was the manufacture of the clinical batch, first ever nanoform material that went out from our facilities. And what we did there was that the process of nanoforming was first developed here on the R and D side and then it was transferred David Rhodes Manufacturing Organization downstairs, which we will visit soon.
And there the clinical batch was manufactured and Then sent to Quotient Sciences in the U. K. Where it was made into tablets and dosed into humans. The formulation itself was made here in NanoFarms facilities by Satoosteep. So this was a great success story and a demonstrator of collaboration between the different teams of Nanophore.
And I'm sure we will have these types of successes in the future as well. With this, I say thank you and I'm pleased That I have been able to host you here and we will move on to the next stage and I'll hand over to Henrik at this stage.
Thank you, Niklas, and thank you, Toramas. What you saw there was our now famous SES technology. Let's move over to quality control. Do we have Director Antonio da Silva there?
Hello. Yes. So welcome to the quality control area. So I'm Antonio da Silva. So as a background, I have 20 years experience in pharma going specialized in the functions of quality control, analytical development, So to cover all the activities that are necessary from bringing early development stage Drugs into commercial phases, so going through all the processes that are needed for GMP Also in the release of these materials.
So before joining Nanoform at 2019 November, I previously was working in the CDMO, Hovion, where I specialized in all these analytical functions. So it was a big opportunity here to accommodate the technical challenges that NanoPharm is developing And to introduce all the necessary capacities in quality control to handle this process and to support The process development activities that are being developed both by Nicholas Pharmaceutical Development And also the manufacturing facilities that you will see. So in here, one of the things we have to start always is the capacity to handle high potent materials such as high potent APIs. So our laboratory is equipped with these facilities So inside our laboratories, we have built up the capacity to support the several stages of our process. So Here in this first bench, we're actually looking at the performance evaluation of our nano foam drugs where we can have this solution testing and we can have also the simulation of in vivo and in vitro in vivo relation between the drugs That we are analyzing and developing.
So before we get here, of course, we need to evaluate the quality And the quality properties of our drugs. So we have several number of equipments, so starting with high performance And go to performance chromatography where we can address and evaluate the issues around quality of our produced Products and also the incoming materials that we receive. So, with these automated systems, we are able to evaluate this quality By chromatography, but also other technologies are very important, such as the thermal capabilities. So we have here an example of an equipment, which is the Differential scanning calorimetry that we can get properties such as melting points and crystallinity assessment of our materials. Also critical is to measure the water content.
So we have here Karl Fischer that allows us to do this And also a particle size analysis. So size matters, especially when we are a nano farming company. And so here we have 2 systems that allow us to go from 7 nanometers into micron sized range, So a broad spectrum of evaluation of particle size. But these are not the only systems we use to evaluate particle size. So very special equipment we need is actually the SEM microscope.
So the electronic microscope allows us to look into the Material to see its aspect ratio and to also evaluate size. So here we have an example of this equipment And the pictures here that we can take looking at the materials and seeing exactly how they are throughout the development activities. So this is not all the capacity we have. So in this room, we will go now to a second room where we have XRPD powder diffraction systems. And so Doctor.
Eric Kissey will take you through that equipment. So, we will go there now. Thank you.
Thank you. Hello. My name is Erik And I have a PhD in Pharmaceutical Sciences. And my background is in amorphous drug delivery systems, solid state Characterization and then 3 d printing of Pharmaceuticals. So I've been doing all this over the past 5 years, and I joined Manoform In the beginning of 2021, as an expert in characterization of Pharmaceuticals.
And over here, we would like to welcome you to our diffraction room where we have our pan analytical Empion 3 series, which is our x-ray powder diffractometer and it's the state of the art instrument that we have over here. Now this instrument comes equipped with all the automation system. So then we are able to run or operate And for 24 hours. Now it also comes equipped with various gadgets such as the humidity generator As well as the temperature control units that we are then able to do performance Of our non formed material and then also track the quality of our non formed material. This instrument is very important to us as it helps us To analyze materials coming from the pharmaceutical development side, also coming from R and D and of course also coming from The GMP facilities.
In terms of product performance, we are able to characterize using our humidity and temperature systems so that we then generate Atmospheres necessary or atmosphere our product will be working in to see whether the quality remains the same throughout the entire Yes, and then throughout the entire month. But that is all from me from the diffraction room, and then I would like to hand it back to you, Henrik.
Thank you, Erik and Antonio. From Quality Control, we will move on to Pharmaceutical Development. Doctor. Satu Makio, please.
So hello. My name is Satu, and I'm the Director of Pharmaceutical Development. So I'm a pharmacist and I have a PhD in Pharmaceutical Technology. And before joining NanoPharm, I worked for Academia as well as Pharma Industry AstraZeneca and Orion Pharma. So when I was working at AstraZeneca, I was part of the unit that had all the AstraZeneca's development project coming in.
So they were scaled up from
Okay. One second, I will check one technical thing here. Gerard, you are shooting this Pharmaceutical Development section. Could you turn on your camera?
Yes, the camera is on.
Camera is on, Gerard says.
Okay. Hold on. Operator, can you see it now? Okay, please continue.
Okay, thank you. So I will continue Explaining my previous experience with AstraZeneca. So in there, I was able to see a lot of different kind of projects and Also see the challenges they might have. So when I was joining NanoPharm, I was really intrigued to understand what SMALL can do for patients And what kind of unique opportunities it can bring to pharmaceutical development. So here at Nano My team is responsible for all the formulation development, preclinical work, so in vivo work and also pharmaceutical support For other functions.
And we cover small molecule and biologicals. And we also cover really Wide range of the like a pharma development. So we start with the preclinical all the way to the clinical. And if we now move forward a bit, I can start with where we do most of the preclinical development. So in this room here, we hoist this manufacturer suspensions for animal pests and other work.
Yes, it's Banu now at the moment working with hydrogels. But as I said, we also cover Development towards the clinical development. So as we know, pharma industry have really tight Time lines and time to market is crucial. So that's why we take the learnings we get from the preclinical Development and take that to the clinical development. And that also enables really like fast Time lines and parallel working.
So in this room here, you can see how we manufacture tablets And developed the formulations for going to the clinical testing. So Traditionally, pharma industry has developed tablets for Phase II studies, But nowadays, there's trend towards doing it already earlier for the Phase 1, where typically before there was only like Truck in capsules kind of formulations. And yes, we can now fully support those activities. And this machine here is fully instrumented, so we get a lot of relevant data how the tablets are compressed. We also have capabilities to work with coated materials.
So we have this dedicated room That we can, for instance, take the tablet press in there if we need to do tablets with coated material. And then I will end the tour by demonstrating you how the nonoform material for instance behaves. So here we have a hydroxicon and a nonoporn material and it actually flows really nicely, Better than we would expect some material to decay. It forms this we call the loose aquiferae, so it's like Small snowballs and that's why the handling of the flowability is easy. But when we disperse this material, then with points to this in this case Rakdos, you can see that there is no agglomerates anymore.
It's evenly distributed And the probability is actually excellent. And then I'm happy also saw a couple of those satellites As we manufacture here. So as you can see, we cover very deeply guided dosage pumps. Okay. Thank you for this and back to you, Hennep.
Thank you, Sato, for that one. From pharmaceutical development, we will move on to GMP Manufacturing, the only site in the world which can now form material. We will start with Doctor. David Rowe, our Head of Manufacturing. Please go ahead.
Thank you, Henry. Hello, and welcome to GMP Manufacturing. My name is David Rowe, and I'm Head of Manufacturing. I joined Nanoform in April 2019. Prior to that, I was particle size reduction lead with GlaxoSmithKline.
This was a global role where I was a subject matter expert for the technologies GSK utilized for size reduction To size reduce API, I worked with the R and D teams in Europe and North America for new chemical entities And also with the global manufacturing organization, both at GSK sites and also at 3rd parties To optimize the existing portfolio. I decided to leave GSK and join Nanoform I was excited with the NanoForm technology to produce nanoparticles as small as 10 nanometers. The benefits of these nanoparticles to the patient and also to the pharma industry include reduced dosage, Faster onsets and Novel Medicines. This is the only facility in the world which has this capability. I'd like to follow on from Nicholas Sandler, our CTO and share the NanoForm clinical trial.
In October 2020, 5 months ahead of schedule, we progressed the GMP clinical make campaign Working as a value stream P TECH Group, that's production, technical, engineering and quality teams working together With collaboration with Nicholas' R and D organization. For client readiness, we are progressing the following. Regulatory, we're working with Fermia for a multi API license. With capacity, We're introducing shift work. We're actually running shifts at this moment in time, and we're also building new GMP lines.
Our 2025 target Is to have as many as 7 to 14 GMP lines. Within the GMP team, There is production, there is engineering and there is operational excellence functions. You're now going to meet some of my talented team who are going to take you on a short tour, who will introduce themselves now. So I'll first introduce you to Peter.
Thanks, David. So my name is Peter Blackburn. I'm the Manufacturing Operations Manager. So my team run the GMP line. I've been with Nanoform for just coming up 1 year, originally from the UK, I have extensive overseas work experience, I've got a background in high end electronics manufacture and aseptic food production.
So today, we're going to take you on a very brief tour of our GMP facility. As David said, we're in the middle of a campaign. Actually running 2 shifts at the moment. So to start the tour, I'm going to hand you over to our team leader, Rosella.
Hi, everybody. I'm Marcela Darmazo, a production team leader. I'm Italia. I moved here to join NanoFirm in 2019. I have about 5 years of experience in cell manufacturing and pharmaceutical development.
I will explain you briefly the material flow. So the materials are taken in from that door on the right, and then they are placed here in the material storage. In here, we have sampling materials. We have gowning materials. We have chemicals and cleaning equipment as well.
And everything is stored in here with the and we follow the first expire, first out principle. When we have to start production, the material is taken into this sampling room Where we have the biosafety cabinets, which is classified as D class. And in here, we sample the inert filler material And the API and also the primary packaging materials. After that, the API is And the inner filler material are taken into this room, which is the dispensing room and the basket It's loaded with API and inner filler material and then taken out and installed in the production line. And I will hand over back to Peter, who will explain you the process from here.
Thanks, Rosella. So as Rosella just pointed out, the
material transfers there from the room on the left hand
side, our dispensing room, There's there from the room on the left hand side, our dispensing room through to the left hand side of the isolator where it transfers through a pass box Then into the pressure vessels, which are the next section of the isolator. So the CO2 comes from the room just over on the left, that's our control room. The CO2 comes through into the isolator, through the pressure vessels and then through into the collection vessels. It goes into a bag. When the bags are then removed through the pass box, comes back to dispensing room So that we can do the sampling.
It then moves through back to the right, through to the small hatch you can see on the wall over there. And it goes through then into material storage for finished product where it waits for quality release. I'll just show you very briefly Our gowning room, just so that you can see, this is a fully fledged GMP facility. So this is our Downing facility. I'll just show you very briefly because the alarm will go off shortly to say the door has been open too long.
So this is what we would consider world class facility. All the gowning is done here. We've got complete segregation of Everyday close and close needed for the clean room. So we'll move back out here. So that's A very brief tour, but hopefully it's given you a good flavor for the fact that we have this GMP facility here, and we're working, and we're working every day.
So now I'm going to pass you over to my colleague, Marco.
Thank you, Peter. Hello, everybody. I'm Marco Minerva from Operational Excellence. I'm a Lean 6 Sigma black belt with pharma background. At Operational Excellence, we work to improve quality, And reduce operational costs.
Lately, we have been working with the daily management process And a visual factory. One example of daily management It's this board over here. So we use this board each day to check all the tasks, follow all the tasks which we have for each day. In addition to that, we have also a weekly meeting and a monthly meeting where we follow the performance. In addition to those, we have started also a Lean 6 Sigma training program to expand further The Lean 6 Sigma Knowledge at Nanoform.
Thank you. David, to you.
Thank you very much, Marco. So Henri, it's been a pleasure to show the guys a quick tour of the GMP facility. I'll now hand back over to you.
Thank you, David, Peter, Rosella and Marco for that tour. Our CFO will come back in the end discussing how many lines we will have in the future. Now from GMP Manufacturing, we will move over to commercial, and I would like to introduce our Chief Commercial Officer, Jan Jones. And Christian, with your consent, I'm going to ask the operator to bring up your team, showing it to the customers and clients and investors at the same time. So operator That we have Christian showing out, Jamie Arnwin, Gonzalo Andrade, Erik
Thank you, Henry, and Good afternoon. I'm Christian Jones. I'm the Chief Commercial Officer at Nanoform. I have a master's degree in chemistry and for the last 20 years I've worked in In development and in manufacturing. I've held commercial leadership roles at Johnson Murphy, a FTSE100 public company, Doctor.
Reddy's, a global generics player and working in the CDMO division and ProSonics As the first employee based in Oxford, UK, an innovative startup in the particle engineering and drug delivery field. This is where I started to get my commercial interest into particle engineering. I joined Nanoform to make a difference, To help grow this exciting technology, and take it into the company that it is today and to position it for the future With a sole purpose to add value to patients' lives. Nanoform has the potential to address a clear gap in the marketplace With its groundbreaking nanoparticle technologies and I just had to be part of that story. I'm truly honored, to be joined in the commercial team With such talented colleagues, let's go around the world to meet them.
Let's first start off with Britta. Britta in Helsinki, over to you.
Thank you, Christian. Hello, I am Britta Mattison and I'm commercial associate. And my role in Nanoform is to support the commercial team with sales and marketing activities. My responsibilities include Supporting the team at conferences and events and in generating and managing business development leads. Previously, sorry, I worked in sales and marketing in private companies and government organization in trade and tourist.
When considering, Nanoform had innovative technologies that can help improve patient lives, Was fast growing business environment and had many experts in their fields pushing the boundaries of science. There was no question that this was the opportunity I was looking for and I have been delighted to work in the company since June 2018. Thank you.
Thanks. Thanks very much, Britta. And let's now move over to UK And we go to Oxford. Jamie, Jamie in Oxford over to you.
Thanks, Christian. Hi everybody. I'm Jamie, I'm the Commercial Insight Officer at Nanoform And I've been enrolled for just over 6 weeks now. I'm a PhD molecular geneticist by training, and for the last 20 years I've held commercial insight leadership roles at GlaxoSmithKline, GE Healthcare, Johnson and Johnson, and most Klein, GE Healthcare at Johnson and Johnson, and most recently I was VP of Enterprise Insights at Biocom Biologics, who are an Indian biosimilars company. I think very simply, I come to work every day to try and positively impact patients' lives.
I joined NANA Forum so I could work with many different companies help them understand how our technology can partner with their medicines to make them even more transformative and even more patient centric.
Thank you, Jamie. And let's go across Europe to Europe and in Portugal, where we have Gonzalo, our Chief Business Operations. Gonzalo, over to you.
Thank you, Christian, and good afternoon and good morning to everybody. It's a pleasure to speak to you this afternoon and morning as well. I'm Gonsal Madras. I'm originally a biochemist by training. After being played in my initial professional career with poorly soluble drug candidates And working with them towards making them clinical and potentially marketed products, I decided that I wanted to move closer to the marketplace and joined Hovbjorn, where I was for 6 years responsible for Innovation Business Development activities over in the U.
S. And in Europe. And after that, joined NanoFarms in 2019, January 2019 because I saw the value that the technology could provide. Looking at my professional career, I have observed the success Of the nano milling technology at Ilan has observed the success that spray drying has contributed to OVION's growth and success over My stint there. And it was clear to me that NanoPharm was bringing on another wave of growth Into the pharmaceutical industry and enabling newer candidates to move into the clinic and into the market.
So it was clear that I wanted to join It's been a successful journey so far and I'm happy to be part of this amazing team.
Thank you, Gonzalo. And let's move across the pond now Stateside to New York where we're joined by Erik. Erik, the floor is yours.
Thank you, Christian. Hello, everybody. I'm Erik Peter, Vice President of Business Located here in the East Coast of the U. S. I began my career as an analytical chemist back in 1994 and have spent the past 20 years Promoting drug development commercial services with companies like Quintiles, Aptuit, Patheon, and Hovione.
The past 15 of those years were focused on offering a wide range of particle engineering solutions, in particular applying a variety of Dray drying and hot melt technologies to successful commercial programs. I joined NanoForm because I saw the many benefits of technology over other leading particle engineering platforms. Coming from years of working with successful particle engineering and formulation CDMOs, This struck me as being the next best thing, in the pharmaceutical particle engineering space and offers the greatest chance of success for the next generation of pharmaceutical Products, I mean, when you add it all up, it results in a win for the patients, a win for the pharmaceutical partners and a win for the environment because this is a green process. And that's a great outcome for society as a whole. So, it was a no brainer to join, Nanoform and represent this fantastic, unique technology platform.
Thanks, Christian.
Thank you, Eric. Now let's go Midwest to Chicago, where we're joined by Sergey. Sergey, take it away.
Thanks, Christian. Hi, everyone. My name is Sergy Lutzer and I'm the VP of Business Development. Before joining the NanoForm last year, I spent my entire career in the CDMO space having held roles in both technical and commercial functions. My past experience includes roles with Cambridge Major Laboratories, Johnson Matthey Most recently with Porton Pharma Solutions.
Having been in the pharmaceutical industry my entire career, I was acutely aware of the solubility and bioavailability challenges that many programs And having the opportunity to join a company with a new unique and game changing technology that can help overcome these challenges was something that I was just Quite excited to be a part of.
Thanks very much, Sergey. And finally, the last but by no means least, let's go to Chris in San Diego. Chris, thanks for getting up before 4 am this morning. It looks like you're still awake and the floor is yours.
Thanks, Christian. Good morning, everyone. My name is Chris Hall. I'm VP of US Business Development. I have a PhD in Synthetic Organic Chemistry And over 17 years experience in the chemicals industry with 15 of those in pharmaceuticals.
I work with companies such as Merck KGaA, SAFC, which is part of Sigma and Aldridge, Pharmofix and Johnson Matthey. I've spent the last 13 years Working specifically in the pharmaceutical solid state arena and I'm well versed in the different techniques and their capabilities To improve the physicochemical properties of APIs, the opportunity to work with Nanoform and our SESS technology, Which essentially supersedes all current approaches in terms of API product performance was hugely exciting and something that I couldn't turn down. I very much look forward to playing my part in improving the quality of life of a 1000000000 patients around the world. I appreciate your time. Thank you very much.
Back to you, Christian.
Thank you, Chris. Excellent. And that's the team. So as you can see, we have a stellar team with a lot of experience. And it's a great commercial team, but also a fantastic technical and nanoform team That we're all part of.
Henry, if we can go to the next slide, please. So I'm going to briefly explain Why we're in this and what Nanoform can do for patients. Ultimately, we want to set north stars. We want to set the best products In the marketplace by our partners working with our technology to improve their existing products, but also to enable Products into clinical development and into onto the market. We want to also help with greater choice, Greater choice for the patient by improving the possibilities, that our technology can do for products, again, entering into the pipeline of development.
We want to empower patients, give them more choice, enable them to go to their physician and to say, actually, I don't want that tablet. I want this one that has nanoformed inside. We want also to improve compliance. We want to be able to reduce, adverse effects, toxicity, pill burden and enable Medications to be taken in a smarter and more effective way. So we want to help patients in every aspect of their medicine journey.
Let's go to the next slide, Henry. In terms of the market that we serve, We work with small molecules and we work in the growing biologics arena. Small molecules still dominate the marketplace. However, that is likely to change over the next 5 to 10 years as biologics take precedence. However, small molecules are still very, very important and have a huge volume within the markets.
With our technology, We want to improve the existing products, but we also want to help new products. And there is a good opportunity, as you can see on the graph on the left, For drug reformulation, to add value to existing products and to even make them better. Now when we look at the graph on the right in terms of biologics that have been launched, You'll also see, there are less, opportunities in the drug reformulation space, but it's going to become a very big market, Particularly in the bio betters. And this is where our biological nanoparticle technology will really play a role as well as again, helping with those north stars In the bio area. Let's move to the next slide please, Henry.
This slide Represents, molecules that are entering preclinical or Phase 1. And as you can see that on the left hand side, It's either oral or IV that are the dominant presentations that are chosen. And there are some presentations in injectable, Subcutaneous, injectable other and a few other routes of administration. However, if you look on the right hand side, that changes. So, you know, oral and IV are still the largest, present, but there's subcutaneous Really is a big, growth area for drug reformulations as are respiratory, ophthalmology and, transnasal.
So lots of opportunities in the drug delivery space. And this is where Nanoform also plays a role. Let's go to the next slide please. What I wanted to do here was just to show, these are the opportunities That Nanoform have seen this year. And you can see them in pipeline.
This is our pipeline by phase In terms of the opportunities that we are looking at and it closely mirrors the market, but there is a slightly more emphasis On the preclinical and phase 1, which we would expect. And this is because the drug solubility and bioavailability challenges Are really ever present in that space. It's where molecules die if they can't get into clinic and that's where our technology Can have huge value. We also have a role to play in the life cycle expansion, the drug reformulation and the 505(2) area, Which is why we also see quite a few opportunities in that space too. As you can see, the global pipeline is over 18,000 molecules in development.
So there's a lot of opportunity for NanoFoam's technology to be applied. Let's move to the next slide, please. Finally, I wanted to show where our technology is being applied. And it's not just about solubility and bioavailability. And this message is clear in this slide.
We are now working with partners, some in collaboration and some as clients, to Investigate how our technology can improve drug delivery in across a whole wide range of areas. These ones that you see on this slide Are the ones we can publicly talk about, but we have many others as well, that we're working on. So on the left, we have Quotient Sciences. We publicly disclosed that we did the NanoMan clinical trial where we showed that using our technology, we could get rapid absorption Of a poorly soluble BCS Class II drug, paroxacam. Moving across, we have the collaboration with Apricia, The only company in the United States, to have a drug on the market that is 3 d printed as an oral tablet.
We're working with them to look at buccal delivery, and this is delivery into the mouth to avoid the first pass metabolism. Now if we can combine nanoparticles for fast dissolution of a poly soluble drug with their oral disintegrating tablet for fast disintegrating, That 1 +1 equals 3 from a technology added value for the patients. Then we move across the respiratory where we have Publicly disclosed that we have worked with the UK Respiratory Biotech for localized lung delivery. Particle size is key in this area. Then we move across to Herantis, where we have publicly disclosed that we are working with the CDNF molecules To try to improve brain delivery, with Herantis and these are biological molecules for Parkinson's disease.
Finally or last but not least, we have nicuity and selenis. So nicuity, we're looking at the ophthalmology space, A really interesting area for nanoparticles and there we're looking to enhance ocular tissue penetration of 2 of their lead candidates. And latest, announcement is with Celanese, a Fortune 500 company in the U. S, specialty chemicals organization. And we're looking at taking their Co polymer drug delivery platform and adding our nanoparticles to see how much more value we can offer for sustained release And modified release for patients.
And that's it from me. And I hope you've enjoyed this presentation. Now, before we move on, it gives me great pleasure to introduce Mike Rehan. Mike is a Thought leader in the pharmaceutical industry. He is the CEO of Ideafarma.
And, Mike sets All pharma companies try to hit. He releases annually the Pharmaceutical Innovation Index, through idea pharma And ranks all of the major pharma companies. He also mentors the heads of R and D of a lot of those major pharma companies. We are honored to have Mike as our Strategic Innovation Advisor. And Mike is now going to present on the opportunities That nanoparticles can have in the biologic space.
Mike, over to you.
Thank you so much, Kristian, And welcome to a quick talk on the opportunity for biologics. And clearly, if we go to the next slide, We tried to carve this into some major areas, but one of the main things, of course, is the industry tends to think of Biologics is large molecules, and it tends to approach them in that way. But of course, the opportunity for that to be small It's suddenly overwhelmingly an opportunity for people to get their heads around. If you think about biologics from the perspective of the pharmaceutical industry, one of Biggest challenges that they have is the delivery mechanism. Traditionally, they think about going IV.
Maybe if they're creative, they think about Going subcutaneous, but the opportunity to get biologics into the blood is a huge opportunity for the industry to get its heads around, Both in repurposing, as we've discussed already, but actually in the early investigation of how that drug might work, Time to blood and the reliability of delivery into the blood is clearly hugely important As we think about biologics' ability to do what they have the potential to do within the body. Okay. Then we can also think about some of those formulations are limited by our ability to get those drugs into The blood or how quickly we can do that, so we think about the world of infusions and other mechanisms, Which are often limited by toxicity issues and other things. If we could change the way that we load drugs into those formulations, Again, we have a change in possibility for our industry. Even further, think about a tailored release profile.
Issues that we have is the peak and trough that we see with biologics, where if you have, let's say, a disease modifier for Alzheimer's disease, which You are limited in delivery to a peak and a trough profile, but you need a constant delivery mechanism. Well, actually the ability to non form could allow you to have an extended release formulation of a biologic, which certainly you can tailor to the patient, you You can tailor to the indication that you're looking to manage. So, we also then we move into this area where Improving uptake for the individual. A lot of the problems that we see with Biologics are delivery. Therein, the uptake of the patient We can get people to take their medicines more readily, more reliably, more predictably.
Again, our pharmaceutical clients have an opportunity to improve The P and L on those drugs that they've been relying on and if we see the profile of biologics within the pharma space, it's most of the revenue of most the major pharmaceutical companies now. But that's thinking the old way and thinking about just improving things incrementally. If we think about Let's think about the idea of new drug combinations. One of the problems with combinations is simply the amount of drug that you need to get in if you think about biologics. Think about putting novel formulations into novel devices.
Think about the ways that you can manage predictive digital solutions With those devices and novel biomarkers, certainly we have this world of combinatorics or combinatorology where Things get unlocked that would not be possible if we didn't nanoform our pharmaceuticals. Well, that's wonderful to be thinking about. And actually, this is where the more creative pharmaceutical companies have to come to Nanoform to say, well, look, there are things that Could be unlocked this way that couldn't be possible any other way. But this world of new drug combinations is clearly part of the new horizon. And then finally, we think about that old world of supply chain and the infrastructure for drug logistics.
1 of the biggest issues when we think about Predicting pipeline development and development structures for pharmaceutical companies is onset of how can we manufacture this stuff. So if you need to build a plant 5 years ahead of being able to use it for a drug like Avastin, which is the way that it works, right? You need to build a new build a new factory, you need to start to plan uptake curves. If we can change that infrastructure, we can make it more agile, in the way that they think about this. We might be able to go for niche populations and to be thinking about more Just in time delivery of biologics into the drug logistic supply chain, Which isn't a trivial issue.
It's a huge issue for anyone that's forecasting opportunity for the biologics in their pipeline. So, I think if we stop thinking of biologics as large and start thinking about them as small, certainly we a whole new horizon of opportunity for the pharmaceutical industry. Thank you, Christian.
Thank you, Mike. Thank you for presenting at Nanoform's Capital Markets Day. It's always a great pleasure to have you, Mike, with us. Now that was a good introduction actually to biologics because now Maria Lewen, our doctor in biologics will present from our side as well. Maria, are you there?
Yes, I'm here. Can you hear me?
Okay, great.
On to the next slide please. So as Henry kindly mentioned, I'm the BioAg team leader here at Nandaform. The company 3.5 years and have been able to administer the part and development of the company. On the right hand side image, the presence of experts and businesses And we have a goal in the second half of the year. So we collaborate closely with the pharmaceutical development Could then support developing the formulations and characterization and Qualitative assessment of the bio particles that we formed.
Next slide, please. So the technology that we have developed is a gentle bottom up process and so far we have used this For processing proteins and peptides that range from 6 to 140 kilodaltons in size. As you can appreciate from the right hand side image, with our technology we can make nanoparticles as small as 50 Nanometers in diameter. On the left, one can follow the development of our technology by produced batches over the years. So we started from scratch in 2018.
And in 2020, we produced a little over 300 batches. Thanks to improved automation capabilities, we have been able to further increase the production rate in 2021 And have completed almost 90% of the last year's batches in biomon's time. Next slide, please. So during the year, we are able to control the process parameters and set the way That we are able to tune the particle size according to the clients' needs. So here you can see 3 images all taken with a scanning electron microscope From different batches with different sizes, namely we have here, one image on the left With an average size of 178 nanometers.
Then in the middle, the average size of the particles is €786,000,000 And on the right hand side, it's close to €1300,000,000 Okay. If we move on, I would like to show you an example of nano forming insulin. Insulin is a small peptide that is about 6 Kilodaltons in sizes. And on the left here, you can see how the unprocessed bulk material looks like. And on the right hand side, how the non formed material looks like.
So it's clear that we can make it small. Well, the next important question is, Has it also retained the biological activity? So in collaboration with the University of Helsinki, Next slide please. We have assessed the activity of the Nanoformed Insulin by using liver cell line derived HepG2 cells, Which you can see on the left image. Those cells express insulin receptor on their cell surface.
And once you add insulin to the cells And it's bound to this insulin receptor. It elicits a number of signaling pathways inside the cell. And we have used one of those AKT as the readout for the activity assay. And we are measuring the comparison of phosphorylated Which is the active protein to the total level of the protein. Next slide, please.
Okay. So here on the left, you can see fresh samples of bulk, which is the unprocessed form of insulin And 2 versions of nanoformed insulin. You can appreciate that the more you add insulin to the cells, the higher is the response And the amount of the phosphorylated AKT protein, which is in the upper panel, whereas the total protein levels in all samples are roughly the same. To assess whether our material stays active, We kept the samples in the fridge for a month and then repeated the assay and the results of the 1 month old samples are presented on the right hand side. So you can appreciate that the nanoform material has stayed active over time.
Next, I'd like to move on to another protein, which is 23 times bigger in size compared to insulin it is. It has a molecular weight of 140 kilodaltons and a complex structure As you can see from the top right image, the enzyme is called lactic dehydrogenase. It is Enzyme which catalyzes the interconversion of pyruvate and lactate and it is used in the 3, to evaluate technologies because it's highly, highly sensitive to share and temperature. So basically, it can lose The activity when even kept in ice and a few hours time when it's kept in suboptimal conditions. LDH is used in the diagnostics to evaluate the level of tissue toxicity and it's elevated in pathological conditions Such as cancer, but also myocardial infarction.
So next slide please, Henry. So here on the left, you can see again the electron microscopy images of the bulk and unprocessed material on the top And nanoform material below. And on the right hand side, there are our first Preliminary results on the LDH activity assay. When compared to lyophilization, which is another technique 2 process biologics, then one can appreciate that based on the literature, the published results show that LDH activity Varies from anything between 40% to 90% after processing. Our NanoFoam material has retained 75 Percent of the activity, which is a good result and which can be improved by further developing the formulation and optimizing our processing conditions.
Next slide, please. So, last but not least, I would like to introduce you our future prospects. So those include building of additional lines to support the commercial projects as there is a lot of interest in us. Then broadening the product production capabilities and last but not least supporting expansion towards GMP for biological chemicals. With that, I thank you for your attention and handing over back to Henri.
Thanks.
Thank you, Maria, for the presentation. Impressive and beautiful science. We will move on to our AI initiative. Doctor. Elisabetha Michelotta, please.
Hello. Thank you, Harry. Good day, everybody. Yes, I'm Elisabetta Michelotta. I'm leading the science and technology team in Nanoform and I will introduce you to Startmap, Our AI tool to pick the winners and turn the knobs of our SES technology.
Before starting, a few words about myself. I have a PhD in molecular astrophysics. And before joining the company, I have been a scientist at NASA working in the field Of nanoparticles in space. I also work at CERN in an experiment that is now collecting data in the International Space Station, I've been a researcher in Canada, University of Western Ontario, at the Institute of Space Astrophysics in Paris and at the University of Before joining Nanoform in September 2019. And yes, one of the reasons why I decided to join Nanoform is because we do things that nobody did before.
And one of these things is STARBOP That I will explain you in the next slide please. So what is StarMap? StarMap is our in house cutting edge Sparse data AI platform that we develop to identify the winners. So the molecules that Are predicted to be the best amenable to our SaaS powered nanoform, the one that will have more success with nanoform, And that exhibit the optimal production characteristics. And in doing so, we will be able to open new opportunities to our pharma Because we will be able and we are already doing this, we can revisit drug candidates that have been previously discarded By artificial intelligence techniques trained on old particle engineering methods.
But we will be also able to pick Quickly, winners among new drug candidates. So how does the process work? Please, next slide. So we are talking here about artificial intelligence. So this means advanced statistics that typically requires a lot of data.
And if the amount of data is not sufficient, it's not possible to make a specific prediction. But in this case, we can get help from sparse data AI. And this is what STARMA is doing. We can augment the results from experiments using our detailed that we developed in house about our process. And this allows us to make sensible predictions about drug development success.
And actually, STARMAP 2.0, our newly released version, It's a digital version of the TESTS technology and allow us to perform a very large number of in silico experiments To make predictions on nanoformability. And therefore, explore the huge number of potentially available drugs that are out there. So which are the inputs and outputs of STAR MAPP? Next slide, please. How does it work?
Well, the input is the molecule. We run it through the process and we derive 2 important parameters. The first one is the solubility in supercritical CO2, Because the first step for nano formation is being able to dissolve the drug in supercritical CO2. So being able to assess this before running the process can tell us how we need to turn the knobs in order to get the product that our customer wants. Also, we predict the propensity to crystallize, because our customers, they prefer having crystalline material for very well known reasons.
So again, if we know whether a material has a high propensity or a low propensity to form crystalline nanoparticles, We can tune better our process. Okay. So let me show you a bit the performances of our tool in the next slide, So, about solubility prediction in supercritical CO2. In this plot, You can see the solubility is a function of the density of supercritical CO2. Density because this is one of the key parameters Determining the solubility of an API.
You can see here a series of solid lines, and those represent the solubility predictions from STARMAP. The field circles are the solubility measurement that we performed in house of compound B. The shaded areas So the uncertainty in the predictions, and these predictions have been performed at different temperatures, which is another key Parameter for the supercritical CO2. And you can see that the field circles are very close or even on top of the solid lines. And this shows clearly that we have a very good match between predictions and measurement.
Okay. What about how to use a stand map? In the next slide a few words. So which kind of data are required and which kind of data structure? Well, in terms of input, we only need Sure.
As an input, again, a very simple machine readable file that is easy to fill and for which we can provide Examples and template. And finally, we can assure that the data are transferred in a secure way, in and out. And maybe even more important, there is no need for human eyes to see the molecular structure. So STARMAP can work without having operators looking at those. And we think that is extremely important because we are operating here with the most important assets Of pharmaceutical companies.
Okay. Now let's move on to our growth. What we have been doing So far, and which are our targets for the future. So in 2020, we were able to perform 10 evaluations per week. Now, 2021, we launch StarMap 2.0 and we can perform 1,000 evaluations per week.
Our target for 2025 is 1,000,000 evaluations per week. And you can appreciate here that The growth has been pretty impressive. We are talking about orders of magnitude. But when we talk about this €1,000,000 evaluation, which one of drugs are we talking about? Well, you can think about, for instance, the more than 58,000 drugs that have been discarded so far in the last 40 years.
You can think about current drugs, more than 5,000, that maybe we could improve somehow. But especially think about the more than 18,000 drugs which are in the pipeline, which are under development. We can focus on those as well. And the one that will be, let's say, proposed until 2025. So you can see here that while these are ambitious targets, But this growth curve is showing that the SaaS technology has been appreciated, Is known.
People are requesting evaluation. And we think that the start map will also boost The growth of the company as a whole and this at the end will benefit patients. And just to conclude, We will reach, and we are reaching these results, combining our expert knowledge. We are a science based company with cutting edge artificial intelligence technology. And this is what will lead us there.
So I will conclude here, thanking you for your attention and back to you, Harry.
Thank you so much, Isabela. Punch numbers and impressive capacity indeed. Talking about numbers, that means we're going to come to the last section before Q and A and that is finance. Albert Hekstra.
Thank you, Henry. I'm really honored to be speaking after all these Tremendous nanoformers. It's been really fun to see you present really impressive. If I go to some numbers, I will not talk about the financials as we did that in the Q1 report, I will talk now about the market And a little bit relate to the fact that when we raised our targets for 2025 from more than 50 APIs to more than 70 And we raised by 40% and also for the lines. Where do we see all these APIs and clients that we can work with?
So, if we go to the next page, please. We have long already said that there are 3 pools of APIs that we can work on. 1 is the already failed ones. And as Elisabetta said, there are Over 58,000 failed drugs during the last 40 years. Then we have more than 5,800 that are already on the market.
And then, we have more than 18,000 drugs in the R and D pipeline. So, there is lots of APIs around. Next, please. One thing which is very clear also that there are 2 trends that support nanoform's growth, and one is that the number of APIs Continues to grow. And now, I'm talking about the number in the pipeline.
So, here you can see the number of APIs in the global pipeline over the last 20 years. It's been growing by almost 6%. And only during the last 5 years when Nanoform has been around, it's grown by more than 5,000. So today, we have more than 18,000 APIs in the pipeline. And remember that 70% to 90% of all APIs in the pipeline Are seen as having some kind of issues or problems with solubility and bioavailability.
Next, please. Christian also already showed that how the split of the big pipeline of 18,000 APIs It's split between the different phases, but here you can see it again. So preclinical is slightly more than half, then you have Phase 1 and Phase 2 roughly the same, And then you have clearly less in Phase 3 because the big cut comes after failing in Phase 2 or many of the APIs, unfortunately. And then, you have some 10% that are basically on the market or going to the market. Next, please.
If you look at the growth trend of these different segments, then remember that we can work in all the phases, but Many of the APIs we work on are in preclinical Phase 1 and 505(2) in the market, But some of them could also be in Phase 2 and Phase 3. And of course, as we move along, we will also do Phase 2 and Phase 3 before we bring them to market. One thing which is very striking is that even though the number of APIs in the pipelines and in all the phases have been growing, Something has happened during the last 5 years in the Phase 3. It's not been growing. And this is, of course, not a good thing from a Humanity point of view that we want more APIs to come to market.
But I think that this last 5 years of no growth in the Phase 3 It's also what you have seen in the new approved NCEs on the market that this has not been able to improve very much from And above or up to 50 new drugs every year. Next, please. It's another It's not only the number of APIs that's been going up clearly, steadily. It's in fact, the number of companies With an active pipeline has been growing even faster. So, here you can see that over the last 20 years, every year on average, The number of companies with an API or several APIs has been growing by 7.5% per year, meaning that 20 years ago, there were slightly more than 1,000 companies with an API.
Now, there are more than 5,000 companies With an API, an active pipeline. And you can see that the growth has been increasing also here During the last 10 years, and for example, during Nanoform's lifetime, the number has increased by more than 1,000. So here, we can clearly see that Christian and his team, they will be busy also in the future chasing new And new companies to work with. Next, please. If you take these two numbers, Number of API growing and number of companies growing even faster.
It's a natural thing that people in the industry know that Much of the R and D in the industry is nowadays done in biotechs, smaller companies. It's not the big pharma who alone does it. And here, you can see that the top 10 and the top 25 big pharma, the proportion of the APIs they have has been going down steadily. And actually, the 25 biggest pharmas in the world, they have less than 10% of the APIs in total. But of course, if you have 25 companies having 1800 APIs, Of course, they have every one of them have many APIs, so they are important to work with as well.
The one graph that is not shown here Is, of course, the proportion of companies that have between, let's say, 3 more than 3 APIs, But are not part of the top 25. And that proportion has, of course, been growing, and that's an important customer potential customer group for us as well. Next, please. Then you can ask where are these companies domiciled. And our strategy today is to focus on the U.
S. And Europe. And Edward, who has lived more than 10 years in the U. S, is always talking about U. S, that's where the action is.
And here, you can, of course, see that U. S. Is almost half or is home to almost half of all these 5,000 companies. But you can also see that Europe is doing really well. So, Europe, France, Germany, UK And the rest of Europe, they are really doing good.
So, the areas we are not at the moment working on, Meaning, for example, China, India, they are not that big part of the pie. So, We have the potential to cater to a big chunk of all these 5,000 companies with our present setting already. Next, please. 1 of the big things with us launching a new technology in biotech is, of course, the strong trend you have seen in the biotech And especially in the biologicals. And here you can see that the biologicals today It's more than 40% of the number of APIs.
So, of those 18,000, more than 40% are already biologicals, And we expect that trend to continue. And therefore, of course, I'm really, really pleased when I see the tremendous Improvement and growth we have been seeing in Maria and her team. But we also, of course, see it from the client interest. Next, please. And then finally, another slide on the market before we go into the targets released on Wednesday.
Here you can see that there are very different many different therapy areas. The big ones are, of course, oncology, Biologicals, but neurological and so forth. And we already work with many Companies in many of these different therapeutical areas. And then, the final slide before Q and A, And this is the one we released on Wednesday. And naturally, I'm very proud of the fact that we have been moving very fast ahead, been growing, Has seen a very strong interest in our technology.
So, therefore, we raised our midterm targets By 40% when it comes to new APIs coming in every year by 25%, and of course, also taking the lines to 35%. So implicitly, you can calculate what the addition from biologicals is. But also from a CFO point of view, I'm very Glad to see that the efficiency and scalability you can see when you don't need to increase the Target number of employees by 40%. So, if you can do more APIs with less growth in the cost base, that is, of course, very good for the company. And therefore, we are happy to reiterate the cash flow positiveness And above 90% gross margin for 2025.
This was my part. And thank you and back to you, Henry.
Thank you, Albert, for that presentation. Lots of data explaining the dynamics where we do operate. This is the first time we show this data in our presentations. So thank you so much, Albert, for that. Okay.
We come to the final section, which is the Q and A. There are 3 ways to ask Questions, they are shown here on Slide 48 it is. You guys can call in the numbers you see there. It's the same feed code from these regions. You can also type in questions in the question box or mail directly to irnanopharm.com.
Okay. I believe some of the analysts will be calling in, but I also hear that we have Juan Al is already in. So operator, I would suggest that we take the dial in first and then the other questions later. Operator, can you help with connecting in?
Thank you. 3. We have a question from the line of Max Hermann from Stifel. Please go ahead. Your line is open.
Great. Thanks guys for very informative and creative use of Online Technology, so congrats on that. Two questions, if I may, to start with. One is I was interested In your GMP element of the tour and the fact that you were doing it currently doing GMP runs. So Obviously intrigued to know what you will be running through on GMP.
Is that still paroxacam or What else would you be looking at? And then in the biologicals aspect, interested in the prospects Of oral delivery of Biologics, obviously, that's almost the Holy Grail of this area. Interesting to see some people's technologies now can deliver certainly larger Peptides orally without nanoforming. I wondered whether nanoforming might add some perhaps Even greater potential for oral delivery. Just those are my initial questions.
Thank you.
So, I'm happy to take you on, Max, and great to talk to you again. And I'm going to give you preliminary answers and maybe Gonzalo will need a little bit sort of tech detail on the oral peptides Since you are a master of the universe in that sense. So you asked about the GMP stuff, and it's clear that my compass is Showing very straight to the north. That is there are 2 kinds of things that we need to do. We need to make sure that the GMP line is running And then we need to make sure that the discussions that we are going in order to fulfill what we need to fulfill this year, which is a commercial DMP project, We do everything we can to squeeze the timelines everywhere when we can.
And this is probably an answer that is Sir, that is halfway to what you want, but I think we will come up with a press release when we have the details that can be released. Maybe Albert wants to say something.
Yes. Hi, it's Albert here. So I think as we have said before, we will press release when we Can do it, but this is just what we say this time. Then I think we can go to the Oral Biologicals.
Sure. Shall I start?
Yes, please.
So, Max, I think you touched upon a very good, maintenance point. It's the Holy Grail of the space. And It is also very important to keep in mind that not all biologics are going to be suitable for our delivery. So size, complex modifications We'll potentially deter some of the assets to be subject to our administration. Having said that, there has been and Novo Nordisk's Riberesus and Ozempic products are a testament of that, A transition from a subcutaneous peptide into an oral delivery peptide.
So the GLP-one analog that Novo Nordisk has Forward has significantly changed the way that we look at biologics and offered also a path and A headway into how to transition a subcutaneous product into an oral delivery route. So, It has been done. It is possible. It has been demonstrated. And it may be that there is a path also for NanoFarms.
Great. Thanks guys. Appreciate your responses.
Our next Question comes from the line of Christopher Udi from SEB. Please go ahead.
Hi there. My first question is The year to date opportunities that by phase that you just sort of a clarification. Can you tell me What exactly that means? That's how many have you come across that you've been able to or had the opportunity to choose between or Yes, that's my first question.
So let me see if I understand what you asked. So there are actually 2 questions in one. How many have we had the opportunities to look at and how many have we been talking about in the reports? And I think it's better to start with the second question first. And since Albert is our number Sky, maybe Albert you want to take this.
So if you ask about the was it N equals 57, then the answer is that those are APIs where we are in active dialogue With clients. It does not mean that we have signed them yet. And that's, of course, Christian can elaborate, but Some of them will be project and some of them will not be project, but those are sort of in active dialogue. Christian, you can continue.
Sure. Thanks, Albert. Yes, exactly that. Obviously, we have a lot more discussions going on than the 57. We have, hundreds of meetings that we're having throughout the year.
But of the meetings that we've had, These are the opportunities where clients have signed confidentiality agreements, disclosed more information about their molecules, And therefore, we're evaluating them. And this is what these are the opportunities we've seen since the start of the year to now, spread by phase of pipeline. And it doesn't mean that we have engaged in a project with them. It just means that these are the ones that we have been discussing.
And Christopher, it's also important to understand that in addition to that, both Elisabetta with her machine and also Gonzalo with his Nanoman project Are looking at a lot of opportunities. So I want to be very careful that there is like the commercial ones that fall under the Christian's realm And then there is all the other ones which fall under the R and D realm, which from my perspective is both preparation for what is to come And also preparing things that we can give to Christian to sell.
That's great. Thanks. And I don't know, is it well, just to follow on from that, how should we think about The split in terms of I mean, you have a certain number of active lines, and I guess these are projects that are going to be taking time even if They don't
even if
they're not generating sales, but I guess that presumably then contributes also a bit to The number of lines per API that you average or per year. And so Do we is this sort of like half of the capacity devoted to this? Or is it A quarter? And I guess, how do you see that evolving over time?
So I will give Albert the opportunity to talk The numbers, but let me talk about the trends. So, we are building, we are polishing and we are serving at the same time. And when I follow the graphs, I can see that we have a big problem. The commercial projects, the customer projects, they take up so much line time That Niklas really has to fight for getting enough so that we can grow with the maximum speed. I give the numbers to Albert again.
Yes. So just sort of we have not given you a numbers what sort of our heat ratio has been previously. I will let Christian talk a little bit, but I will give you an indication that I assume that all our commercial guys will say that Nano Forms hit ratio with client perspectives has been quietly much higher than the average in the industry. So we have had a very good hit ratio number. We don't give you exactly, so how many of these, for example, 57 will be a project in the coming 1 to 2 year.
But what is clear that these projects, some of these 57 will be a project And what is the proportion and how much capacity do we have? And therefore, of course, it's very important to us that we want to try to get Better and faster at doing a
project on
the line. So, if we had if we have 11 lines, The non GMP lines, how many projects can we do per year on that line? And our target there, of course, as we said earlier, that in the first project With a big client, for example, it might be that the project takes 300 days. Then we are trying to push that down to would be 200 days, so it would be 100 days. And at some point, we want to be in a situation where we could do a take in a new API and do a project POC project in, let's say, 90 days or even potentially at some point faster than that.
And that means that we could do 4, 5 projects Per line per year or even more. On the GMP side, it's of course also the same that The projects, how many projects can we do per line? And there, of course, it's again the same that it depends on how big The amount of material we need to ship, but our basic understanding is that this will be a same trend that as the years go by, we would be Better and faster or doing more projects per line. But Christian, if you want to add something or Gonzalo?
Yes, I'm happy to add to that, Al. I think I don't think we're going to disclose what our Exactly what our hit rate is, but it is higher than, well, certainly what I've seen in my experience As an industry hit rate, and I think that's a combination of the technology being attractive and there being a real need for it. But at the same time, I would just say, we have seen such a huge interest In the technology that these numbers are not, I guess, not surprising that we see this many opportunities from Beginning of January to the 4th June. We're only 6 months in. So what I would say is, You know, it puts us in a privileged position to really look at those projects and see where our technology can have the most value for our partners And really try to prioritize those projects.
We want to work with everybody, but we do have Some limited resources. So we can't work with every single client that comes to us. But We do want to really help our partners. And so we want to try and also help prioritize those projects.
Well, potentially, I could add to that also that remember that we have also over the last year, we have expanded Our offering a lot. So, especially now when you have smaller biotechs or companies that don't have the in house resources, It's very good for us to be able to also cater with pharma development and QC and stuff like that. So, for example, the RPD machine you saw, that is also one thing that we used to outsource that From the University of Helsinki, but now we are doing it internally. So, the good thing that we can do lots of things internally, but that also means that every part of that The organization need to be able to keep up with the inflow of the projects.
And maybe if I may close this Question by stating that Grow Polish and Service, it's really, really important to get that Try it right. And it also means that I spend a lot of time with Gonzalo and Nicolas on having this sort of balance Where all the time you want to secure the quality, but at the same time you have to change. So on the one hand side, you want to keep everything as it is because that's where you become the best. But on the other hand, My job is to make sure that we evolve all the time. So how do you stay the same and evolve at the same time?
That's where you need a magician. And Albert is the magician, you know, when it comes to the finance. And I like to think that potentially, I'm at least an apprentice when it comes to a magician as How to stay the same and evolve at the same time because this year is really at the core of what Nanonfor needs to do right now.
Well, yes, sorry, I want to comment this. One more thing is that this is very interesting. You heard some of the people talk about automation today. And of course, it would be great, I mean, when you look at Elizabeth and going from SEK 10,000,000 to SEK 1,000,000 in 6 years evaluations per week, unfortunately, we will not be able to do that Sort of what my son calls in real life, meaning that you build the lines and you do the physical projects. And I think that Maria, what she showed, 100% growth and what Niklas and the team has done on there, but Still, there is the physical world and but I also think that by doing automation On the lines, we will get so much more efficiency also from how long does it take and so forth.
So Automating and using AI and all this will help a lot.
And Mike Ria said Something I took I don't take a lot of notes during the settings, but I took one note. Mike Ria talked about combinatorical growth. And being a former mathematics major, I really like that because everybody knows that exponential growth is fast, But combinatorical growth is actually faster. And when it comes to risk management, it's so cool because Combinatorics is really to combine what you have. So when you create things and you get them into control, then when you start to put them together, You have an opportunity to grow really fast and still keeping the risk profile sort of at bay.
So, of course, from my share, this is something which I Very, very much think about and very, very much try to execute.
As you can see, we could talk a long time about But let's go to the next question. It's an excellent question,
We have a question from the line of Lars Hevring from Danske Bank. Please go ahead.
Yes. Thanks for taking the question. I just wonder a bit, I mean, having listened to this impressive and broadening range of Conversations etcetera in the company. Could you just touch upon a bit upon trade secrets versus The patented technology that you have, I mean, you interact with more and more companies. You do work more and more people are working for the company.
How do you keep the It's Equisafe, say, in house and more companies, they have access to your pre form APIs, etcetera. If you could Touch upon that and of course how, I guess, technologies will be improved over time And Harry is going to take care of that.
Okay. So this is a great question, and it comes up every now and then. So I start by giving a general overview. Basically, what we have been saying during the last 3 years still holds. So we want to keep the technology close to our chest.
And this means that people basically provide powders for us and then go out. In the collaborations where we work with other technologies, we need to be very cognizant I'm sort of careful with this. It's interesting to see that when we move forward now and we are in practice During our negotiations about the GMP contracts, this is something that's going to be really important because The authorities require, of course, certain disclosure. And I think it's there will be a certain necessity to disclose, But it's also clear that the trade secrets, you will not need to disclose all of them. Then when it comes to sort of tradecraft, How to do compartmentalizing.
The basic rule is very simple. Those who build, they don't run. And those who run, they don't build. And it's something that We really sort of adhere to. In the commercial work, which Christian can talk more about, I don't see us having big troubles on this.
People basically Understand and they agree to the fact that in order to be able to draw all The good stuff that comes out from Nanoforming. These are the boundaries that we will stick to. But maybe over to Christian, how do you see it from Customers and commercial point.
Sure. Thanks, Edward. Yes, we work in the pharma industry, which is Highly secretive in terms of confidentiality. People come to us because we have something novel and innovative. And all of our partners respect the fact that we have know how, intellectual property And trade secrets.
So it's about structuring the framework of any agreement that we have To make sure that those aspects are covered respectfully by both parties and our partners have confidential information, know how and trade secrets that they Also need to be we need to be respectful of. So, it's I think it's part and par for the course, Any technology company operating in the pharma industry needs to have the highest levels of IT security, Has to have the best practices for information management and for confidentiality of our partners' Information and we take information very seriously and we look after it. We protect Our information and we protect our partners' information to the best possible standard.
And maybe it's also good to add And go back to what Elisabetta said. So we have put resources into answering the request and demand on our customers. Since they rightfully so feel that their sort of most precious assets, which is the structure of their molecules, Is something that they would rather not disclose if they can't do. We have catered to that need and worked On having an AI solution where no person needs to see the structure.
Okay. That's very helpful. Can I also ask about the Very interesting presentation as well in from Marie in Biologics? And she touched upon that. You're You're going to approach a bit slight bigger molecules like the standard ADG based antibodies.
What's The what's the differences there from a regulatory perspective in terms of what products You could bring into clinical trials compared to this more molecule side.
Sure. So if I Structure this question in the following way. Maria, if you want to answer it, then you are, of course, welcome to do so. And maybe Gonzalo also want to help out here. I first give a sort of general answer.
It is clear that the money lies somewhere around 170 kilo daltonnes. So, if you really plot the size versus The biggest opportunities, they appear to lie at a little bit larger sizes. Then you can ask, is there a difference between SEK140 1,000,000 SEK 170 1,000,000? And the answer is yes, there is a difference, but it's not huge. It's a clear difference between €400,000,000 and €170,000,000 though.
Basically, the larger they are, the more fragile they are. And that means that the gentleness of the processing becomes really, really important. With this sort of first Stop answering your question. I hand over to Maria and or Gonzalo, how do you want to answer this?
We can give the floor to Maria first.
Yes. So, I would say that In terms of restrictions, there are no restrictions that's why we could not take antibodies. This has been a developing story and We are eager to test those next.
Yes. And Lars, I think that One item that I always bring up is that depending on the post Post translation modifications of the antibodies, that may have an impact on the suitability of the antibodies for the technology that we have developed and that is something that we still need to confirm how this complies and how this affects The overall structure of the molecules after processing, right? So that's where we are today.
And maybe if I may add on the sort of scientific side on this. It was very intriguing for me to hear That when you when I started to ask a little bit about, okay, which are the main components to characterize A biological entity. It is less clear cut than on the small molecule side. So some people say, is the electric point, some people say activity, some people say the BioSmile structure. But it is clearly more spread out and part of what I as a sort of scientifically trained person is Very, very interesting in this.
Okay, what is the most effective way of characterizing these biologicals Because that is something which is going to be important for if we want to create a star map also for the biological side. In order for an AI to be effective, one needs to have a very good taxonomy, if you want. And the sort of Gordian approach that we have taken is, okay, let's hit the literature, let's see what people agree on and let's start From that sort of set point and then let's listen to the customers, the things they say is more important most important, let's incorporate that too. And I think this is a very good way to start. It will take us a certain distance and we will clearly be among the front runners also in this exercise.
I stop
All right. Thanks.
Thank you. Thank you, Lars. Operator, can I jump in here? So we have some questions Coming in through the e mail function as well. We are running out of time, so I would like to take at least I want to take one Question from the e mail function.
And then I believe we have analyst Arsen Guevakam also calling in and we will take him after that. Okay. So Alberto Nedver, I sent these questions to you. We have the questions from Mattias Heglom, Sector Head, Healthcare Equity Research, Handelsbanken. Here's some positive feedback first.
I will read up that actually. Thanks for hosting this CMD. Flawless execution with so many speakers tied in from around the globe, but also a virtual tour on-site, impressive.
Thank you.
First question from Matthias. In September 2019, you announced a technology evaluation together with AstraZeneca. Since then, I can recall we haven't heard much about this collaboration. How long does this technology evolution typically last? And what is the next step We should expect to hear from this partnership.
Help me understand the path forward here, please.
Okay. So if I first give an answer, Then I give the word to Christian after that. Our collaboration with Astra is strong and we are both Moving forward the way we want to do that. We're actually if I remember correctly, Christian, this is on Tuesday. We're going to have the next meeting, where we are going to talk specifically about both strategic and Tactical things that relate to our ongoing collaboration.
So we have been working closely with AstraZeneca. We have been very happy with This way they work with us and hopefully also they have been happy with the way we work with them. But maybe you want to add something to this.
Sure. Thanks, Edward. And thanks, Matthias, for the question. Obviously, our relationship with AstraZeneca It's public, but the content of the discussions is highly confidential. So I can't disclose any information with regards To the progression or where we are with them as a partner.
But I there's probably as much as we can say. We are working with them. You're aware of that. What I would say is in general The technology evaluations can be either narrow or they can be very broad. And if they are broad, then they can last for some time And they can look at a range of molecules.
So I would probably say that Hopefully, at some point, we will have some more news to share. But at this point, we can't disclose anything else on the relationship. Thanks.
I'll move on to the second question. Secondly, the number of partners are increasing at an impressive rate, but many of them remain undisclosed to us on the outside world. Will they remain undisclosed until they commit to a typical licensing deal with upfront milestone and royalties or when will we know their name?
Okay. So I would like to start to answer And maybe Albert want to continue then. We have basically 2 things we need to get right. We need to get right our interaction with our customers, partners and prospects. On the other hand, we also need To get right our interaction with the financial markets.
And this means that we will always be as open as we can And as closed as necessary.
There was a follow-up question also relating to this that Some of the partnerships have been mentioned. And so, Mattias mentioned Soraya and Aprizia, Celanese, While others remain undisclosed. I think Christian can take this, but this is, of course, a negotiation with the client and depending on their Internal policies, but Christian, please. So, the question is the number of partners and collaborations have been growing rapidly. Why are we disclosing some names and some names not?
And those names that have not been disclosed, when We'll be able to disclose them.
So, yeah, happy to take that one. I mean, I think we're not unusual in the nature of what we're doing. Every single pharma customer and partner is very, very different. Each partner has different policies involved internally within their businesses. Some are more open, to announcing relationships, compared to others.
And some are highly secretive And don't want any disclosure of relationship at any point. But At the same time, we recognize that we're a public company and we need to inform our shareholders of our progression. And As and when we can, we obviously will continue to work with our partners and I'm sure that we will be able to release more information As projects progress and our partners are more open to disclosing the information. Unfortunately, it's not a straightforward answer to your question, but We work in a very complex and highly regulated market. So we have to just respect that as well.
And maybe I can give you another sort of piece that you will like. It is clear that when there is A filing for marketing authorization. There will be a lot of information In that pack, if I remember correctly, in the old days, when you had everything in paper, it was 10 meters of paper on the shelf For a single product. So, when we are at the point where we are going to start to get the first products on market With a Nanoformed component inside, at least at that moment, there will be a lot of information available.
Okay, thank you for those questions and answers. I would like to move back to the operator for the dial in mode. I believe we have Arsen welcome there, please.
Our final question comes from the line of Arsen Gecan from Kepler Cheuvreux. Please go ahead.
Hello, gentlemen. Thank you for taking my question. I have 2. First of all, on your new target, does the increase only From Biologics, do you see also more traction for small molecules? And the second one is related to the Pharmacological profile of Nanoform Biologics.
Are you able to control the release With your technology, because I think that for some biologics, physicians would like to have a more linear release of the drug. So at this point, it could be interesting to develop.
Okay. So if I start with a later question and then come back to the first question. So basically, you asked about whether we can talk about what kind of release profiles and most importantly, if we can achieve More linear or less dippy, if you want, release profiles. I think we're a little bit early to hear disclose Details on that. Usually, when we have a data pack which we are sort of comfortable with, we're happy to release it.
Maria, Gonzalo, anything you want to add
Perhaps if I start, Maria, if you want to say anything else after that. Yes, I would agree that it's a bit too early for us to have a solid data package to disclose at this stage. If we were to have that, we would have certainly put forward today.
And then if I go to your first question, Arsen, the new target, does it solely come from Bayer or does do we also have Increase and traction in small molecules. So I answer your question in 2 parts. The new target is mainly derived From the biological side, and we do have a solid increase in the traction on the small molecule side. Albert has raised his digital hand.
Yes. So I could say like this that it's clear that when you look at, for example, the Q1 And you look at the N equals 57, it's the growth on the small molecule side is really good. And then also from the biologics side. So we have we are building more lines there. So let's say that the additional SEK 20, They come both from Biologics and also from the Small Molecules side, but mainly from the Biologics side.
Excellent. Thank you, Arce, for the questions. Operator, I believe we have One more from SEB.
Yes. We have a question from the line of Christopher Ude from SEB. Please go ahead.
Thank you so much for letting me take one more question. It's to Mike Ria, if it's possible. I was just wondering, I mean, I guess, When it comes to the pandemic, it's been certainly a trying time for everybody, but It has also been a pretty tremendously exciting time in terms of drug development to You see the silver lining. And I just wondered if you could maybe share your thoughts on any learnings from The COVID vaccine monoclonal antibody and other therapeutics development for that have taken place during this time and The extent to which sort of there are things that can be applied from all of this Massive process or processes to drug development, both in general and as it relates to time lines.
So Christopher, I will ask Henrik to help me out here a little bit. If I remember correctly, Mike may not be on this call anymore, but the question is very relevant and we're happy to provide you With Mike's comment and answer post this transmission. What I can say though without being as Well, we're seeing the topic as Mike, of course, is that COVID has done something tremendous for the industry, Which also helps Nanoform. Nanoform is a momentum machine and COVID Has broken one of the sacrosanct truths of the industry. The truth is that it takes at least 10 years To get the drug to the market.
COVID has shown that it can be done in 1 year. And as being a momentum guy Who wants to move fast and who knows that time there is not much time. This one thing, It is so important for the industry, and I think it's also very, very important for us. Gonzalo has his digital hand raised.
Thank you, Edward. And I think that one of the key items that we have also learned Not only from the vaccines, product road to market, it has also been recently demonstrated by Amgen's Recent approval. So they have received approval for a monoclonal sorry, for a new drug therapy Under 24 months, and they've announced it in late May. So that's something that is really massive When you can bring a product to market under Fast Track approval in under 24 months From initial proof of concept, Phase 1, Phase 2, Phase 3 and then market launch. Massive progress.
And this is a transition that's the fast track Paths that FDA and also other agencies are putting together will change the overall landscape.
Yes. And I think that I want to spend a minute on this if the operator allows. This year, it cannot be underestimated, the importance of this. And for a fast mover like Nanoform, This is music to our ears that there is a need, a request from patients, From regulators, maybe even from K Street to see can we do this faster? Of course, we need to do it safe.
But I don't think that safe and fast needs to be orthogonal. They can live together. It's just a matter of doing things smarter. And we think small is powerful, But we also think smarter is faster. Christian?
I would just yes, I would just add, Chris, I spoke about this recently on a panel about COVID and being a catalyst For innovative growth for pharma development. If you look at products like infliximab, a subcutaneous version, That's really been driven forward during the COVID pandemic because it means patients can effectively have this at home. It's beneficial for freeing up ward time for the physicians. And it's a win win win for the patient, the And it provides a lower cost burden on the health authorities. So when you think about products like that, that effectively Could have been developed, 10 years ago and could have been out there and could have been pushed.
I think COVID has been a real accelerator for innovation in drug reformulation and it just goes to show The benefits that optimized drug products can deliver for patients and the whole healthcare ecosystem. And I'm sure that now that everybody's going to be very sensitive about that. And I dare say if these Products have been around 10 years earlier. Everybody would be on them now. But it's just highlighted the importance of optimized product Performance for patients, but also for the rest of the healthcare system.
And that's ultimately where we feel we can add a lot of value to.
Thanks so much. That's a very helpful answer from all of you.
Sorry, Chris, do you have one more question on?
We have another question from the line of Max Herman from Stifel. Please go ahead.
Great. Thanks. Just a quick one, which is going back to your slide on clinical year to date Obviously, I appreciate these aren't all Existing agreements, but I wondered how that's progressed, say, this time last year, how that would look? And then I noticed on the Slide 16 with that. I wondered how your balance historically, you wanted to keep a balance Between 505(2) type projects and NCE type programs.
And I wondered how that has evolved because it looks here from that slide that Maybe there's a bias towards NCE, so just trying to understand that. Thank you.
Okay. So Let's hope that I got your question. I think your question was, is there a bias towards MC? So the slide that you're talking about basically says something about where we have ended up. And where we end up is a function of where the customers respond and where we look.
I still think one should not read too much Far reaching conclusions. This is a situational map. It shows where we are now. It Gives some guidance, but not total guidance on where we want to be moving forward. We have always said that we will not only do 50 5b2s, we want to be there work with them for NCE assets.
And on the other hand, it's clear that when we look at the transition probabilities and the time lines that the 505(2) routes Are fast. Then if I have understood it correctly, it's also clear that the sort of in vogue of the 505(2)s, It's something which may or may not be constant. So, Albert has his digital hand raised.
Yes. So, I think we have not Previously shown these numbers. Christian can then talk about how it has been evolved, so what would it potentially have been a year ago. But what I think is We wanted to show you this because it's interesting to see that it's when we started this, our thinking was that We want to be we will probably work a lot in preclinical and Phase 1 in the beginning, and then, of course, when we take The APIs forward in the clinic, then the proportion of Phase 2 and Phase 3 and all the way to market will sort of come the natural way. Then we had the question in when we did the IPO that some people said that why don't you work only on 505(2)s Because financially, that is more potentially rewarding.
And there we said that we don't want to work only on 505(2)s. We want to bring all new drugs also to the patients possible. But again, here, this is a very early sample And here, you can basically see no impact yet or very little impact yet from STARMAP. So, if we have done Tens or up to 100 plus evaluations or even 1,000 valuation. The impact from the STAR map is very small.
We believe that the impact of the STAR map will be much larger. It could be enormous in 5 years' time. If you take from SEK 1,000,000 And you choose 1 or 2 candidates and you start to talk with clients about them. It's a totally different story than if you talk to a tech scout and the tech scout says, This is our model compound. Nothing has worked ever on this, try to nanoform it.
So, to answer your question, We will work on both 505(2) and then seize, but it's interesting to see that we will continue to show when we Move forward how this but it's interesting that already now we see that there is a correlation with the sort of market situation. But of course, Our dream would be to change the market in a way, being able with Starmap To really change the dynamic of the market. Yes. But that we will have to wait for. But Christian, comment on So what would the NHAD look like 1 year ago when we did the IPO, if it's 57 now?
Yes, that's
A very good question. And I mean, it would certainly be less than half of where we are now. But I think I'd like to just come on to the point Max you raised with regards to the NCE and 505(2) piece. And I think Certainly, as Nanoform started out, we were very, very much focused on solving the bioavailability and solubility issues with pharma. And so that's where our Our sort of first commercial focus was pushing out those opportunities and really trying to apply our technology to as many molecules as we can In that space, and clearly there are a large number of opportunities there where people have got problems.
So that's reflective of what we see in the data. But then when we think about the 505(2) space, we are also gearing up And speaking to people and having lots more discussions in that space. And certainly that's been progressing through the last 12 months, our focus into that area. But at the same time, the opportunities have to make commercial sense. So it's not just a case So saying, well, let's nanoform something and then take into 505(2) product.
It has to have patient benefit and it has to have Has to hit all those 3 P's, the patient, the payer and the practitioner. And it has to make sense from a Ananna Parks' call technical perspective. So we can be much more highly focused in the 505(2) space to identify the real Rockstars that are going to sort of take us forward with our partners and potentially dismiss some of the ones that They might be incrementally adding value, but not enough value for patient benefit. So we want to really take products forward that are going to drive patient value and Be successful products because those products will be lower risk to take forward, and they'll be faster to take forward. But I think More selective about which ones we want to invest the efforts in, in that 505(2) space, which I think also perhaps is slightly reflective of, the numbers that we see.
But I think if you look forward 12 months from today, I'm sure it's going to be a different picture. So that's all I can say at the moment.
So Max, let me see if I can say it more briefly. We used to say the most important thing is can we nanoform it Because that's what the tech scouts want. What we are doing now together with Jamie and together with talking to more senior people on the commercial side is, Should we nanoform it? And the question in the first space is, can you nanoform and the other one, where can nanoform add most value? And these are on the surface of it, they are very similar.
But when you think a little bit more about it, they are very different. And here, we have been putting a lot of thought and a lot of work into sort of Making sure that we mature into the second viewpoint because 1 or 2 years ago, the important part was, Okay. Let's show that we can Nanoform and then let's see if there also would follow benefits. Now people know we can Nanoform. And this allows both our partners and our prospects to sort of skip that part and directly dive into what's important.
Okay, Which one have the largest probabilities to get new possibilities for the patients?
Okay, good. Excellent. Thank you, Max, for questions. Operator, I think we've come to an end on the dial in side. Am I correct?
Exactly. There are no further audio questions registered.
Thank you. We have more questions on mail, but we are 25 minutes over to you. So I will do the following. I will make sure that all of those of you who have e mailed in, you get your answers soon. And we decide to complete the Capital Markets Day here with some concluding remarks from our CEO, Edvard Ekstra.
So I promise you to be short. First of all, thank you for giving us the most value thing you have, your time. I hope you have enjoyed the show and I hope you have learned something new. When you log out from here and wonder, what did they say? They said one thing, small continues to be powerful.
Thank you.