Vitrolife AB (publ) (STO:VITR)
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CMD 2023

Dec 12, 2023

Patrik Tolf
CFO, Vitrolife Group

Good morning. Welcome to the Capital Markets Day for the Vitrolife Group. Thanks everybody for joining us here in Stockholm, and everybody who are joining us online, very warm welcome to you as well, wherever you are in the world. My name is Patrik Tolf. I am CFO for the Vitrolife Group, and has been so, since January 1, 2022. Throughout today, we have a fantastic lineup of presenters. We will be joined by key opinion leaders, and also then combining with management representatives from the Vitrolife Group, wider management team.

In addition to us presenting, and you can listen to presentations, I would also like to say that we have a fantastic marketplace that you will see to the right in this room, where you will also then be able to touch and feel on our products, and also then talk to colleagues and experts in the various areas. We have an agenda that we have set out then to reflect our new corporate strategy. We will have a couple of breaks. There will be one coffee break that we will have at 11:10 A.M., for 10 minutes, and come back here so that we can continue the agenda at 11:20 A.M. And then we will also have lunch. That will start at 12:30 P.M., and that's also then an opportunity for you to visit the marketplace.

Get back, and we will start it here by 1:15 P.M. sharp for continuing on the agenda. Bronwyn will then later sum up the event, and then we will have time for questions at the end of the presentation. So the presentation will then and the Capital Markets Day will end at 3:00 P.M., but we will be here. The marketplace will be here, so take this opportunity to ask questions, listen to the experts, and explore more on our products and services. With those introduction words, it's a pleasure for me then to hand over the word to our CEO, Bronwyn Brophy. There you go.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Thank you, Patrik. So good morning, god morgon, excuse the very poor Swedish pronunciation, and buenos dias. It's fantastic to have so many people here physically present in the room with us in Stockholm, and also a big thank you to all of those joining online. We're really excited to present the Vitrolife Group corporate strategy. The team have worked very, very hard, and before we kick off the day, I do want to acknowledge and thank the wonderful employees and team at the Vitrolife Group, supported by some incredible key opinion leaders, who've really partnered with us in developing and helping us to present what we believe will be a very exciting corporate strategy that will enable the Vitrolife Group to drive profitable double-digit growth long into the future. So some introduction to myself. I have... I'm recognizing some faces in the audience, which is nice.

But for those of you who don't know me, if you haven't already detected, I am Irish, Bronwyn Brophy, or to give me my full, Bronwyn Brophy O'Connor. I have been working in the med tech and life science industry since 1997. I actually started my career with Johnson & Johnson. I then moved to Covidien, which was acquired by Medtronic, and then I moved to Thermo Fisher Scientific, where in actual fact, I was based in Uppsala, running the old Phadia business, globally. So a lot of experience in med tech. I have two big passions when it comes to my career, and that is innovation and access to healthcare.

So you can imagine for me, as the new CEO of the Vitrolife Group, it's a huge pleasure, honor, and privilege to be able to come in, into a company that's really striving to bring innovation and helping to improve access for patients in the IVF space. So that's essentially me in a nutshell. Okay, so I'm going to move on then and talk to you a little bit about the Vitrolife Group. You've seen some of these high-level statistics on our opening video. I'd like to draw your attention on this occasion to our new mission. And our mission, the mission of the Vitrolife Group, is to be the leading global partner, leading global partner in reproductive health, striving for better treatment outcomes for patients around the world. This is the mission of the Vitrolife Group.

You've seen from the opening slides, we are present in 125 countries. In 2022, we delivered revenues just in excess of SEK 3.2 billion. And of course, we have combined and integrated two wonderful companies, pioneer Vitrolife, who you all know, a great Swedish success story with Igenomix, also an incredible success story in the field of Genetic Services to create the Vitrolife Group. And I would have to say, as an incoming CEO, I'm really impressed and pleased at how smoothly that integration has gone and how well the teams are working together. Our values. I'd really like to draw your attention to our values, because essentially this is what will define us as a company, how we operate with all of our stakeholders, doctors, patients, embryologists, our shareholder community, our board, our employees. Our number one value, integrity.

Number two, quality. Vitrolife Group is synonymous with quality, something that we really want to preserve as we move forward. Innovation. Innovation, we have been known as being pioneers in the IVF space, and we need to continue to do so in order to drive further technology leadership. And then finally, collaboration. We have brought two together, two powerhouses in the field of IVF, and we want to ensure that we are collaborating across our business areas and across our regions around the globe. We're a very well-balanced company. As I mentioned, I've spent 26 years working in med tech, and I can tell you, this is the first time that I have been able to present such a balanced share of distribution of revenue in terms of geographies and regions.

So approximately one third of our global revenue year to date comes from each of our regions, with Americas 33%, EMEA being our biggest region with 36%, and APAC, where we are very strongly represented, most notably in China and in Japan. In terms of the balance of our portfolio from business areas, we're also very well-balanced, and the acquisition of Igenomix has essentially spread out that portfolio. We have a fantastic Consumables business. It's been a growth and profit engine for the company, but now we reduce and our reliance on Consumables and are able to additionally drive growth from the Genetic Services side of the portfolio. And then, very importantly, our Technologies business based in Aarhus, Denmark, where we have our time-lapse technology. So a well-balanced global company in terms of revenue and in terms of contribution from our business areas.

We are also present in countries where 94% of all of the IVF procedures globally are taking place. So we don't have a need to do significant geographic expansion, but rather ramp up in those geographies where we are already present. Our portfolio is... It's best in class. We have an end-to-end portfolio that touches the patient and/or the embryo on every step of their IVF journey. And with this portfolio, combined portfolio, end to end, we want to drive our vision, which is to enable people around the world to fulfill the dream of having a healthy baby. So again, the vision of the Vitrolife Group is to enable people to fulfill the dream of having a healthy baby. What I like most about this slide is that we can start with something like carrier screening.

So a couple, before they even embark upon the IVF journey, and you'll see this at our marketplace, can decide to have themselves tested for genetic genes, all the way through to supporting the patient on that journey. Time-lapse technology, a significant portion of the embryo's life is spent in the time-lapse incubators. So we really are bringing such value to the core of the IVF lab and to the entire patient pathway. This is something really important when it comes to the Vitrolife Group. Our portfolio is uniquely positioned to capitalize on what we would call divergent or differing standards of care. What do I mean by that? So essentially, there are two ways to assess an embryo in order to select the embryo with the highest degree of probability that it will result in a successful pregnancy.

The way that is mostly and most prevalent in the U.S. is genetic testing, and of course, with our full portfolio of tests, we are able to aid clinicians, doctors, and embryologists around the world to genetically test embryos and help them in their assessment and selection. But equally, in other parts of the world where genetic testing is less prevalent, our time-lapse technology also allows for embryo evaluation and aiding embryologists and clinicians in the selection of embryos. So we have a portfolio unlike any other, where we are uniquely positioned to capitalize on the standard of care in the U.S., which is going further down the path of genetic testing, and the path which is most common outside of the U.S., which is through embryo evaluation and time-lapse. However, how are we going to stay ahead of the competition and further differentiate ourselves?

Our next generation platform will combine these two technologies, the genetic assessment and the time-lapse technology, to streamline workflow, to bring more advanced embryo selection, and to increase capacity and ease of use. No other player in the IVF market today will be able to do what the Vitrolife Group is planning to do, due to the fact that we are combining the genetic services and the time-lapse technology. We continue to innovate. This is just a sample of some of the products and tests that we have launched this year, and I'd like to draw your attention to the media. So Vitrolife Group has been at the forefront of media development... Some might argue media has been around for a long time. How much more can we innovate?

Well, I think when Professor Gardner comes onto the stage, you will see the relentless way that we have continued to pioneer in media development in order to ensure that we are giving embryos the best-in-class media as they progress on their life and pre-implantation. So even in areas like media, which some might argue is moving towards maturity, we continue to innovate. So I've spoken a lot about our company. I'd now, now like to talk a little bit about the market. One in six people globally are affected by infertility. So there are approximately 100 people in the room today. 16 people in this room have infertility issues. They may or may not be known to that individual, but that is the reality, one in six people. That's a pretty high prevalence.

If you look at other areas of healthcare, you will struggle to find a statistic whereby one in six people globally is impacted. Yet, of the 134 million babies that are born annually, less than 1% are born via IVF. Why? One in six people affected by infertility, yet less than 1% of all babies are born with the help of IVF. Essentially, there are two key factors which are restricting the number of babies born with the help of IVF. Factor number one is treatment outcomes.

Successful treatment outcomes following an IVF procedure are still hovering between 30% and 35%, and you're going to see a fantastic presentation from Professor Carlos Simón later in terms of how we can strive to move the needle and take IVF from what he calls, and I love this phrase, "IVF 1.0 to IVF 2.0." The second factor that is restricting both access to IVF treatment and affordability. So affordability and access around the globe is still restricted, and although it is getting better, and I'll show you that in coming slides, it is limiting the growth and also limiting people's ability to access treatment no matter where they are in the globe. So best estimates are that this market is predicted to grow between 5% and 7% in the next 3-5 years.

Just imagine, just imagine how much more this market can grow if we can improve access and we can improve treatment outcomes for patients. So this is a graph which shows how outcomes have improved between 1992 out to 2019. It's a good story. We're now reaching 30%-35%, but is that enough? Well, we would argue, no, it's not enough. It's not acceptable that only one in three couples or one in three individuals that embark on this journey will take home, a healthy baby. One of the greatest, I guess, leakage points, is possibly the best way to describe it, in that journey, is that less than half of all embryos that are transferred today result in a successful pregnancy, which makes us start to think: What can we do at that embryo to transfer to pregnancy stage in order to improve those outcomes?

I believe that Professor Simón's presentation today and the work that he has been doing over many years with IVI and with Igenomix will give us some sense in terms of how we can move the needle in this, what is a very complicated ecosystem. I've spoke then about global access and affordability to treatment. This is definitely constraining growth, but it is improving, and if we look at the top three countries around the world in terms of IVF treatments, they are China, Japan, and the U.S. And in China, province by province, we are seeing the ministries of health stepping in to provide improved reimbursement and coverage for their citizens. Why? Well, Chinese birthrate is, is dropping, and it is becoming a national priority. Additionally, in Japan, wide coverage reimbursement for Japanese citizens. Similar challenges when it comes to population and birth rate.

And in Japan, what we're already seeing in Japan, it's probably one of the countries with best coverage, is not just access to treatment but also access to the latest technologies and tests. And then in the U.S., while we don't see government stepping in per se, insurers are most definitely picking up the baton and increasing options for employees of companies. Just as an example, I find this statistic really interesting. One of our largest customers for the Vitrolife Group today, one of our top five customers in the U.S., in fact, is an insurance company. So insurance coverage reimbursement, definitely improving in the U.S. What are the additional market dynamics that are at play in this market? So clearly, growth and demand, delayed maternal age, all of the factors that we know. Clinics are really struggling in terms of staff.

This is a healthcare that's prevalent across all sectors, shortages in nurses, shortages in embryologists, shortages in doctors. We're seeing consolidation of clinics. This slowed down quite a bit in COVID, but the pace has picked back up again. What are the implications to the ecosystem of this continued consolidation? Regionalization of standard of care. I've spoken about the more prevalent use of genetic testing in the U.S., and then patient empowerment. We were having some fantastic conversations at dinner last night with some of our key opinion leaders, and Dr. Rosen was saying that U.S. patients come in, they're informed, they want the latest tests, they want to know what's going to improve their, their probabilities. Patients are better informed, and they are taking and having a bigger say in terms of their pathway and their, their treatment.

So, in answer to these market dynamics, what do we as the Vitrolife Group, as part of what is a complicated and interdependent ecosystem, what do we need to do and how can we support? Well, clearly, capacity and access is an issue. Automation and digitalization is going to be extremely important in this industry. If you have clinic consolidation, growth and demand, and staff shortages, we have to find a way to automate. IVF, as it happens today, no matter where you are in the world, is a manual, labor-intensive procedure. Standardization and scalability is going to be really important as we continue to see this consolidation happening, and I heard a new statistic yesterday, which is that 50% of all clinics in the United States are part of a consolidated chain. These chains, in order to scale, are going to need standardization and automation.

They will need the help and the support of industry and Vitrolife Group to do that. Diverse portfolio, I've already mentioned that, and then communication and education for patients is going to be paramount going forward, and we certainly need to step up our efforts in this area. So, over the coming 4 or 5 hours, we will present to you the Vitrolife Group's corporate strategy with focus, focus being an extremely important word. Focusing on 5 key strategic pillars, where we believe we are best placed to address the challenges that the IVF industry faces and also the opportunity that it presents. Pillar number 1, we at the Vitrolife Group will own the platform connecting products and services. What do we mean by own the platform? We want to further develop embryo evaluation. We want to connect products and services, help workflow.

Back to that whole standardization automation. We believe that with the time-lapse technology, combined with our portfolio and our genetic tests, we are uniquely placed to own the platform on the IVF journey, and we need to enhance that portfolio with additional products, tests, and services. Innovate, innovate, innovate. We have been pioneers in IVF. We need to continue to be pioneers in IVF. We have to, we have to enhance our R&D capabilities. We need to complement that with targeted M&A opportunities that support our play of owning the platform. Third strategic pillar is we need to accelerate in key markets.

I'm Irish, I've been living in Sweden for 3.5 years now, and I can safely say at least 10 Swedish people have said to me, "Bronwyn, be less Swedish, be more Irish, and be bold when it comes to accelerating across the globe." And we will be bold, okay? We need to increase our presence in the U.S. market. The U.S. just doesn't happen in and of itself. You have to invest, you have to increase capabilities, you have to have footprint, you have to have presence, you have to have Americans on the ground, and that is what we need to do in the Vitrolife Group in order to capitalize on what is the third-largest market in terms of cycles, but the highest market in terms of value. China is a really, really interesting one for the Vitrolife Group.

Again, I've been working in healthcare for 26 years. It's unusual, it is unusual nowadays to find a med tech company that is doing exceptionally well and better than local competition when it comes to China. We are. We are doing very, very well in China. We can't afford to be complacent around it. We need to bolster our investments in China, but we are very, very confident in terms of our ability to continue to drive double-digit profitable growth in this very important market. Optimize our go-to-market model is the fourth strategic pillar- will be the fourth strategic pillar for the Vitrolife Group. Our Senior Vice President of Sales and Marketing, Rickard Ericsson, will present the plans in terms of how we are going to optimize our go-to-market model. How are we going to leverage the breadth of this incredible portfolio that we have?

How will we bring more digital, more better interactions, to our, our customer portals, how our customers order our tests? So a lot of room for improvement there, but I do think we're starting to get some, some very nice traction. And then finally, we need to drive operational excellence in, in increasing investment in R&D, ramping up in the US. This costs money, and we believe as a company through our operational excellence program, sponsored by our CFO, Patrik Tolf, we will be able to implement a scalable operating model, we'll be able to synergize on our processes, and we should leverage digital in order to increase productivity. So essentially, these will be the five strategic pillars of the Vitrolife Group strategy going forward. We're going to deep dive on each of them throughout the course of today.

I hope you feel as excited about them as we do. But prior to that, we would like to start the next session with the history of IVF, and we're going to have two incredible presenters. Our first presenter will be David Gardner. I rarely resort to notes. I like to know what I'm going to say and say exactly what I mean, but when somebody's CV is as impressive as Professor Gardner's, I'm afraid, unfortunately, in this instance, I'm going to have to resort to notes. So I would like to introduce as our next speaker, Professor David Gardner. David is a fellow of the Australian Academy of Science. He's a distinguished professorial fellow at the School of BioSciences at the University of Melbourne. He is Scientific Director of Melbourne IVF, and he is a Director of ART Innovation and Research at Virtus Health.

Professor Gardner or David, I hope you'll allow me to call you David, is a true pioneer within the field of IVF, and he has been instrumental in the development of several Vitrolife Group products, which are now in use worldwide. Professor Gardner has traveled all the way from Melbourne in Australia to be with us today. So can I please ask you to give a significant round of applause to Professor Gardner, who will talk to us about the history of IVF. Thank you all very much.

David Gardner
Scientific Director, Melbourne IVF

Thank you. Thank you, Bronwyn, and good morning, everybody, or should I say, good day, folks. So they've asked me to talk about the history and the future of IVF. I think that's really important because if you're gonna look to the future, you have to know where you've come from. So I'm gonna share with you a very brief 40-year window of what is human IVF. I'd also like to share with you my team's contribution, supported entirely by Vitrolife, and how together we've effectively shaped how human IVF is performed today. So I've had the pleasure of being funded by Vitrolife for the past 25 years, which has been very grateful, and it's been a phenomenal team to have worked with. So a little bit about me. I've been an embryologist and worked in IVF for 40 years.

My wife thinks I have a bit of an obsession, and she's absolutely right, I do. This is something, as I hope I show you, is ridiculously marvelous to work in. Basically, I get paid to study life, which is very cool. I trained in the U.K. at the University of York. I went to Harvard Med, and then I went down to Australia to work with the pioneers, Trounson and Wood. In 1997, I moved to Colorado, and it was there, at the Colorado Center for Reproductive Medicine, that we translated a lot of our basic science ideas into clinical translation, and we introduced what we call blastocyst culture and single embryo transfer. In 2007, I moved back to Australia, and in 2017, I took up the position of Scientific Director of Melbourne IVF, which is Australia's largest IVF clinic.

So I keep my feet in two camps, research and clinical translation and treatment. And it was back in 1997 that I met with Peter Svalander, and we started our journey together, with Scandinavian IVF Science as it was back then. The Google Scholar is a simple metric which shows and reflects sort of your scientific impact. And myself and my dear friend and colleague, Carlos, are a very few. We've joined the elite club of the 100-plus citation of Google Scholar. Anyway, this is what it's all about, the first week of human life. We've all been there. The beauty of this is that we start life with the fertilized egg.

The egg is the largest cell in the human body, and it's an amazing cell because basically, it's adapted to sitting around in the ovary for up to 40 years and still give rise to a viable pregnancy. So it's a cell that's basically adapted to doing very, very little for a long period of time, and the fertilized egg is very similar, which means it has unique nutritional requirements. For example, it can't use glucose. Most cells that you and I have are using glucose all the time. Eggs and early embryos can't use glucose. They have a very quiet metabolism. The embryo then develops and differentiates as it progresses through the fallopian tube. About day four, it enters the uterus, and the individual cells then flatten against each other and sew each other up into an epithelium.

And this facilitates the creation of what we call the blastocyst. And this beautiful structure contains the baby right in here, and this outer layer of cells goes on to be the placenta. It consumes vast amounts of glucose and oxygen, has a very idiosyncratic metabolism. It's like no other cell in the body, and it's the most active tissue in the body. So here's the point: within one week, we've gone from the quietest tissue in the human body to the most active tissue in the human body, and a completely different nutritional requirement, and that was the problem. We had to work out what the embryo wanted, and it turns out the oviduct to the uterus also provide very different environments. So this is the start of IVF. This gorgeous picture, the gentleman to the right is Sir Professor Robert Edwards.

He won the Nobel Prize in 2010 for medicine and physiology for his work in human IVF. The lady on the left is Jean Purdy. She's effectively the world's first clinical embryologist. What I want to show you is, this was taken in the 1970s, and this is the kind of incubators that we started to work with. They were terrible. They couldn't regulate gas very well, and they about held temperature. In order to create an environment that was more stable, what the guys did was they grew their embryos in these glass jars, or as I like to call them, a womb with a view. And what you can do is you can purge that jar, and it creates a very stable environment.

In fact, I first saw this in 1983 on my first trip to Bourn Hall, and I did my entire PhD using the same kind of glass jar. The significance of that is that Louise Brown, the world's first test tube baby, was grown in that glass jar. In the 1970s, and indeed all the way up to the mid-1990s, we didn't have anything made for us in human IVF. We had to make it all up. We had to beg, steal, or borrow from tissue culture or be very, very clever and come up with something new ourselves. We had to make our own media, and the media were very simplistic, and as a result of which, there was incredible lack of quality and consistency across.

It was really because of this that the founder of IVF Sciences, which then became Vitrolife, Peter Svalander, Peter was the first person in Sweden to do a process called ICSI, intracytoplasmic sperm injection. So he was a real pioneer in Swedish IVF, but he really struggled to get the materials he needed to do routine IVF well, so he formed his own company, and this is one of the first invoices in 1994, and the first product was this ICSI product. So now I'm gonna take you through the evolution of the culture media that we use. So the early embryo culture media were pretty bad. They were very simplistic. We didn't understand what the embryo needed. They were empirically derived.

The catch was, we could only grow the embryo for two days, maybe three at most, and yet we then put them back in the uterus. The problem with that was, it was the wrong environment for the embryo, and implantation rates were very, very low. On average, maybe 10%-15%. So that's, that's quite a bad situation for the couple. So to compensate for that, we would put back two or three embryos in order to raise the opportunity that a pregnancy would take. Indeed, in 1995, the average number of embryos being transferred was four. That's the average. Think about that. So that means infertile couples contributed disproportionately to multiple gestations. So twins, triplets, quads even were, were coming, and these are not good outcomes for anybody having a pregnancy, by the way.

So ironically, we were giving these poor patients pregnancies, but they were not good pregnancies and not good for a healthy baby. Along came this chap called Gardner, and my approach was to actually ask the embryo what it wanted. My approach was to investigate what was the composition of oviduct and uterine fluid. And it was through this combined approach, over about a 10-year period, that we came up with a sequential media, a media based on the oviduct and the uterus, and it turned out it grew the embryo all the way to the blastocyst. And when we transferred the embryos at the blastocyst, they had very high implantation rates, which was really, really exciting. And this ultimately led to single embryo transfer, which is now the standard of care worldwide, single blastocyst transfer.

Along the way, we realized as we were making our own media, before we managed to get our relationship with Vitrolife going, we couldn't buy chemicals of suitable compatibility with an embryo. We could buy cell culture-tested chemicals, but something that supports a somatic cell in culture can be very dangerously deadly to a sperm or an egg or an embryo. So we developed an assay by which we could screen out all of the chemicals, so when we made the media, we knew that that would be the way to go. And that was the same philosophy that Peter Salander had, and that was really where the marriage started, was all about quality. And over the last, gosh, now 30-odd years, we have a commitment to ongoing optimization of G-Series Media. I never use optimized. It's always optimization, continual improvements to what we do.

Indeed, in 1998, we were able to do a prospective randomized trial to prove that blastocyst culture was significantly better. In fact, we got implantation rates of up to 50% per embryo, hence the move to single embryo transfer. The nice thing about it was, in 1998, Vitrolife launched the G1, G2 as a commercial product, so I'm delighted to say it's in its 25th anniversary. Again, just to focus on the quality control, we developed an assay that was very quantitative. Rather than just look to see if media could produce what we call these blastocysts on the top left and top right, we actually then developed an assay where we could look at the number of cells in an embryo itself, and that indeed was related to success.

So this became a very quantitative assay, and indeed, we created this in Denver, and I believe it is the industry-leading assay for all of embryo culture media. This is the lab in Denver. For those of you who've not seen a human IVF lab, this is actually nicer than most human IVF labs. It's an amazing facility, and we screen raw materials as well as final products, so it's a really important adjunct to ensuring quality in what we do. Now, embryo scoring. How do we assess an embryo once we've grown it? It's very easy to assess a two-cell or a four-cell or an eight-cell 'cause it's got one, two, two, three, four, five. You can do that, right? But how do you assess these beautiful structures called the blastocyst?

Well, the point is, because we were the first to routinely grow and transfer the Blastocyst, I got to come up with my own grading system, which was great. So I came up with a very, I'll call it elegant, alphanumeric system, whereby I graded the embryos and gave them a number of 1-6 based on the degree of expansion, because that relates to its metabolic activity and health. So that was a clever thing. The next thing you could do is you could grade the inner cell mass. So A had many cells, bearing in mind, this is the baby. So if an embryo scores an A, it's got a very good chance it's going to give you a baby. And the egg on the trophectoderm means it's got a very good chance it's going to implant healthily and give you a baby.

Turns out that this system that I predicted would hold for about 12 months, has become the world standard. Pretty much most embryos in every country around the world are selected using the Gardner Grade, which is indeed rather humbling. But it's subjective. As you can see, I could make an opinion on this, but the next embryologist coming along may have a different perspective and grade it differently. Then along came time-lapse. At this stage, we only could look at the embryos statically every day. With time-lapse came the capacity to look at the embryo every 10 minutes of its development, of its entire life. So this revolutionized our perspective of embryo development, and as I like to say, who knew that all the really interesting stuff happened at 2:00 A.M. in the morning? But it did.

But as a result of which, we got a lot more information. We created algorithms, and then together with the team at Virtus, back in Australia, we created the world's first artificial intelligence to select embryos. It was called Ivy. This was then acquired by the Vitrolife Group and is now known as the iDAScore, and you're going to hear a lot more about iDAScore later on. But with iDAScore, it means that we've taken away the subjectivity and variability between embryologists when it comes to selection. It's also way quicker than the human, so we save a lot of time. I've talked about culture media, but one of the things that we have to do is get the embryo back into the uterus in a transfer medium.

Now, historically, people were just using the culture medium to put the embryo back, but that didn't sit well because implantation rates, I believe, could be better. And so we undertook an analysis of what was going on in the uterus itself, and what we observed was this wonderful molecule, hyaluronan, increased dramatically in concentration at the time of implantation in both the mouse and in the human. Now, you're all familiar with hyaluronan in the dermal, and cosmetic industry. It's one of these lovely things that plumps up your, your, wrinkles and gets rid of that. And that's because it has this incredible capacity to bind water and expand. It also has a lot of other biological functions, and it was that that we took advantage of.

We found that not only did hyaluronan improve embryo development in our culture dish, but when we did the transfers, we got significantly higher pregnancy rates in the mouse model. We then translated this clinically and observed exactly the same thing in the human. That if you transfer a human embryo in the presence of high levels of hyaluronic acid or hyaluronan, you get increased pregnancy rates. And that led us to create EmbryoGlue. EmbryoGlue has now been shown, these are data taken from this Cochrane review in 2020, that with the number needed to treat with 14 patients, you get one more baby, live baby, born if you transfer the embryos in this specific medium, EmbryoGlue.

And indeed, recently, the ESHRE, the European Society of Human Reproduction and Embryology, published this in Human Reproduction just a few weeks ago, where they looked at good practice and what the recommendations, what was the data, what was the evidence to support add-ons in human IVF? And when it came to the various things, EmbryoGlue was one of the only things that they endorsed as actually evidence-based to improve transfer outcome. So it doesn't stop there. Like I said, we're always optimizing, not optimized. So one of the things about working in a laboratory is that you can create, whether you believe it or not, stresses, because it's very artificial. It's incredibly artificial, and one of the biggest stresses that we face in a laboratory is oxygen. Now, in this room, there's 20, around 20% oxygen, and it's what gives us life.

Paradoxically, it's also the thing that ultimately kills us. It's responsible for our aging through accumulated oxidative damage. So it's a paradoxical gas. It, it gives us life, but in the end, it takes it away. Within the female reproductive tract, levels are about 5%. So exposure to atmospheric oxygen, which is four times higher, can induce all kinds of stress. We use atmospheric oxygen during gamete collection, preparation, ICSI, embryo evaluation, and some laboratories still use it for embryo culture, during cryopreservation and biopsy. We can't get away from 20% oxygen, and the trouble is, stress is cumulative, so it keeps adding up and adding up. The embryo itself actually contributes to oxidative stress through its own metabolism as well. So what can we do? So we developed an antioxidant strategy.

We're all familiar with the concept of eating a diet, a healthy diet, a balanced diet, rich in antioxidants. The same should be true for embryo culture, have a balanced antioxidant environment. And we focused on many antioxidants over the years. The three that we ended up with as a functional group were lipoic acid, carnitine, and N-acetylcysteine. And we showed in animal models that they had a highly significant effect during embryo culture, in IVF, and during cryopreservation. And this led to the Gx media. This is the new series of media that contains those three antioxidants. We then did a prospective trial in Melbourne, and one of the things that we showed was that the antioxidant group supported a much higher, significantly higher fertilization rate in ICSI. In other words, male factor patients.

So these are patients whose sperm are suffering badly and are more susceptible to oxidative stress. Furthermore, we got one more embryo formed in these patients, so theoretically, the cumulative pregnancy rate could be higher for them as well.... So over the last several years, we've continued our commitment to optimizing culture media, and I'm delighted to say that there are other media in the pipeline of the G-Series. It's far from over. That's the culture media, but what about future developments in the IVF lab? What we do today in the IVF lab is pretty much what we did 40 years ago in terms of physically, and it's also very much, a group of artisans working, very skilled, to do what they do.

So I proposed that the way forward is actually, if you're gonna make IVF more efficient, cheaper, more accessible, we're gonna have to introduce a lot more technologies. So these are a couple of reviews, if you're interested, that really guide you along that way. So here's our beautiful embryo developing. It's always in motion. It's always in communication. This cross-section of a tissue is the human fallopian tube, and the embryo's always talking to the mother. And this is what we do in vitro. We put it in a polystyrene culture dish, whether it's in an embryo culture incubator or in an EmbryoScope, and it sits there. And this troubled me for a long time. So 30 years ago, I wrote a review on the future of IVF, in which I predicted that blastocyst culture, blastocyst biopsy, vitrification were gonna supersede what we did.

But one thing I also predicted would be this, which is a perfusion culture, and instead of leaving an embryo in a static environment, you could actually perfuse media across to mimic the gradients of the oviduct to the uterus. You could also sample the media for biomarkers. The problem with that, of course, was engineering was in no way, shape, or form able to support that concept because the embryo is smaller than a full stop on a printed page. It's a tiny, tiny entity, and engineering just didn't exist. That all changed recently with the development of 3D printing, whereby now, using two-photon soft lithography, we can create devices at the micron level, and this for the very first time, is enabling us to create devices that we can house an embryo in and indeed then perfuse it.

This type of device is the way I perceive the future of automation is gonna be because we will have what we call a universal carrier, which you can house the embryo in. In those devices, you can perform ICSI, you can even perform cryopreservation, and today, I woke up to the news that a recent study that we performed has been accepted for publication, whereby we used this for ICSI, and not only did we reduce the time to do an ICSI case, but the embryo development was significantly improved. So I do believe this kind of approach is gonna help us lead to automation. So to summarize, working with Vitrolife, we were able to transform how human IVF is done. We moved away from cleavage-stage embryo transfer, low implantation rates, multiple gestations, and now we have single embryo transfer leading to healthy babies.

We've continued to be a leader in media development for the past three decades, and we continue to do so. And for that, I'm very grateful. Thank you. We're moving to more objective and quicker means of embryo selection through the introduction of artificial intelligence, which is really exciting. And finally, the future of IVF, I propose, will be using increased automation to facilitate greater volume of patient access. Thank you very much. Thank you.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Thank you. Thank you, David. I would now like to introduce our next speaker, Professor Carlos Simón. Also very, very impressive CV, 39 years as a reproductive endocrinologist and scientist, scientific director of the famous IVI Clinic since its founding and beginning, founder of Igenomix, applying genetics in IVF, trained in Valencia, also in Stanford, is currently now president and founder of the Carlos Simón Foundation. I think Professor Simón is world-renowned, probably the most world-renowned pioneer of IVF, studying the mechanism of implantation and also the endometrium. Can I please ask you to give a warm welcome to Professor Carlos Simón?

Carlos Simón
Professor of Obstetrics and Gynecology, Igenomix Foundation

Thank you. Thank you very much. Thank you very much for such a kind presentation. Well, I'm delighted to be here, and I would like to walk with you with the maternal part. I take David's embryos, as you have seen, and I'm going to tell you how this follows, because our main issue here is our patient, and our main objective is to have a healthy baby at home. So by doing this, this is what I would like to show you. So first of all, I would like to disclose that I'm working now in my foundation. I'm also founder of several startups, and I collaborate as an external scientific advisor with Igenomix, part of the Vitrolife Group. And just to present myself, I have been...

I am a physician scientist, working for a long time in reproductive medicine. I just put 39 years, pretending that I'm younger than my friend David, but this is not the case. But, this was the only reason for this 39. No, I am about 40 years. I was trained at, University of Valencia and Stanford University. I have been the scientific director of IVI for more than 20 years, since we were only 3 doctors, and it was already acquired very recently by a big, by KKR, I think. I founded and, I was the scientific director of Igenomix, for, 10 years until it was acquired by, Vitrolife. I'm now professor. I have been professor of OBGYN in University of Valencia, for the last 30 years, and also I am senior lecturer at Harvard.

I am the president of my foundation, and this is the Google Scholar that David mentioned to you, what it means for us. So, I would like to start by setting the basis of, regardless of all the hard work that we have been doing, regardless of what we have done, we are still have a huge room for improvement... and this is what we are here. Unfortunately, live birth rates still, they are very low, and this is global rates that you can find worldwide. And genetic disorders, I mean, we are not better than nature in terms of genetic issues. So genetic disorders still affect 1% of children, and this, this account for this 20% of pediatric hospitalization and 20% of infant mortality.

This is our big demands to be better off in order to improve this, for the best of our patients. If we try to understand where is the main problem that we have, this is the situation. I just bring some statistics from the Netherlands, but this goes in, worldwide. We are very good, as you have seen, in getting the oocytes the best that we can. You have seen how formidable the development has been in developing human embryos, and David has been shown his great work. Now, we are transferring one embryo. This is a huge thing. We used to transfer, as David mentioned, four as a mean. But even with that, once we transfer the embryo, pregnancy does not occur.

I mean, pregnancy, the big gap is this 45% that we lost from the moment that we transferred the embryo in the black box up to the moment that the patient become pregnancy, and more important, until we have the delivery of a healthy baby. So this is where I have concentrated the work of my life, trying to understand the implantation process. Because this is what happens when we have the embryo inside of the uterine cavity. The embryo has to attach to the surface, penetrate, invades, and placentation will start. And to do so, the embryo have to go to these developmental processes by which first, the embryo just recognize the surface of the human endometrium, and there is a microbiome there in order to have to pass this first. Then, the embryo cross talk with the mother.

In fact, we have shown that how important is the mother in terms of improving and transforming even the genomics and the transcriptomics of the embryo. Then the embryo should adhere to the surface of the epithelium. This is the most important barrier for the embryo to start pregnancy. Once this barrier is passed, the embryo invades, and the syncytialization is going to control this entrance of the embryo inside of the endometrium. If this goes wrong, you will end up with a preeclampsia if this is shallow. If this is extensive and goes to the myometrium, we will have percreta or accreta, which means after delivery, placenta doesn't go out, and there is a big problem, we have to do a hysterectomy or even things will go worse. So this is where the action is.

This is the periconceptional space, and this is where we have been concentrating our efforts to understand this big gap of knowledge that end up with a big gap in results. And now we can do that. We have been going through different methodologies, but now we are in the century of genetics. The twenty-first century is the century of genetics. Next Sunday, you are going to have here the Nobel laureates. In medicine this year, the Nobel laureates goes to the those that they invented the mRNA vaccine, genetics. Last year went to Jennifer Doudna, CRISPR-Cas, genetics, and so on. Because nowadays, our genome can be read, our genome can be written, and even can be hacked, can be changed, can be just modified if we need it.

So taking advantage of all of this huge knowledge, we have been using the genetics also to improve our results in this part of the medicine, which is reproductive medicine, using the approach of personalized precision medicine, moving from population average to real medicine based on person's individual biology, and that's why we have incorporated genetic test to really determine the best time, the best moment, as this can be done routinely in oncology. So this has been the genetics improvement of what we are doing now in reproductive medicine. And, as Bronwyn mentioned, the journey of reproductive medicine starts with the couple, and we have to start with the couple to prevent these recessive genetic diseases.

Because, nowadays, the couple is the way that we start to do this, then we go to the periconceptional space, and as you will see here, we will have many things also for the future. For the couple, 80% of humans in here, if we are 100 people, 85 of us, including myself, we have at least one recessive genetic mutation. I have three. If your couple happen to have the same, then one in four of your children will be affected. And we talk about very severe issues, cystic fibrosis. We talk about all of these things that you hear, and they can cause the suffering of the children. And the risk to have this remains exactly the same throughout the lifetime... and, this is about 2.5%.

If you consider you are familiar with Down syndrome risk that happens with age, all women now, they are screened by Down syndrome. However, for this couple risk of recessive diseases, the only very recently we have started to really plan the trip from the very beginning, you have, as we do in any trip. So this is very important, and this is why we in Igenomix and now in Vitrolife Group, we are taking care of this. Because in 5% of couples, they will be at risk of have one affected child, which will go for this morbidity and mortality rates. And in 88% of children that they are born with that, there were no possibility to know this in advance.

So now we use this expanded carrier screening, which means to understand the status, the genetic status of the couple. Nowadays, we do exomes, and we concentrate on the genes of interest, and we are able to say to the couple, "You have no problem, go ahead." Or in case that you share the mutation, you can go to an IVF cycle, and we can select the embryo that will not be affected, and then you can have your normal IVF cycle done. So this is something that is important. Well, the human embryo is the next part that you have seen in this periconceptional space. And the human embryo, we have been also working with the genetics.

The genetics of the human embryo is the history of since 1995, and could be the history of the actual scientific director of Igenomix, which is Carmen Rubio, my dear colleague and, my dear PhD student. She started doing these genetic studies using FISH, which is a very subjective technology, analyzing two or three chromosomes from one biopsy from, day three embryos. Then, we moved to understand the whole karyotype of the embryo using array CGH, or, or just SNPs. Then, next-generation sequencing was available, by which the capacity was improved, and we were using blastocyst biopsies, which is to take three or four cells from the trophectoderm of the whole ball of cells here.

Nowadays, we have been able and to improve this by doing the genetic and chromosomal analysis of the embryo without touching the embryo, just analyzing the cell-free DNA secreted by the embryo to the conditioned media where the embryo was present. She's going to tell you about that. She went from the whole journey from her PhD thesis in FISH, creating the product, which is called EMBRACE, the commercial product that is commercialized by the Vitrolife Group, in order to go non-invasive, considering the embryo as a patient, as in medicine, all non-invasive technologies are just picking up on that.

So this is the situation, and in this, the Vitrolife Group is also the pioneer, having the first test by analyzing the genetics of the embryo, now without, avoiding embryo biopsy with all what it means in term of cost, in terms of losing some embryos by doing the procedure, and in terms of, looking to the future of this non-invasive technology. And... So what I say is exactly that. This is now the actual technique by having a biopsy of the embryo and analyzing the genetics, and this is what now Vitrolife is doing by analyzing just the drop of fluid in which the embryo has been grown for the last 40 hours.

By trying to understand how it is possible that the embryo secreted cell-free DNA, we have been collaborating with the best in the world in embryo imaging, and we have this paper published very recently that made the cover of Cell, and it have and in fact, there is a patent from that, that is called the Vitrolife Group, by which we are able to really go further in the embryo imaging. This is how we can see the embryo now with dyes, with non-invasive dyes, that they can be used in order to further understand. As you can see, this is the DNA, the cell membranes, and the cytoplasm comparison with the actual morphology that can be seen. So this is just a step forward to the future.

And this is my Christmas gift to my friend David Gardner, and to all of you, because now we can see the human blastocyst as we have never seen before. Look at these images. This is where the embryo will come from. This is the inner cell mass, David. This is what David envisioned 30 years ago to see that. So this is the type of imaging that we can have now with the technology that we are using, and Vitrolife has the patent for that. So... And the next step is the mother. The next step is how this embryo goes and start implantation, as I mentioned to you. First, they have to, the embryo has to deal with the microbiome, the endometrial microbiome that is present at the surface of the endometrial cavity.

Because we are not only surrounded by microbes, they are living on us, helping us to produce our most important functions, mainly in the gut, but also in the skin, and also in the brain. Reproductive tract is no exception. So we have, microbes living there, and we know now what are the good guys and what are the bad guys. In Igenomix, we understood, we published, and we went to all these studies trying to understand what is the physiological and the dysbiotic endometrial microbiome. In fact, this was our last publication, by which we were able to demonstrate this association of a specific endometrial microbiota signature in good success, which is live birth. For us, live birth is the best success. Also, what is the association with reproductive failure in case of miscarriage or no pregnancy?

And we are able to recognize those guys, either in the endometrial tissue, but also in the endometrial fluid, so we can go to the non-invasive very soon from this. This is called the EMMA test, that we have been working with that for the last four or five years, and now the next step could be to go to non-invasive. So we have done this in Igenomix, now Vitrolife Group, but now it came the very first independent interventional studies from that. This is from Japan, using our EMMA test. Those guys, they were able to demonstrate that by analyzing—this was a study in which half of the patients, they did not get the EMMA test, half of the patients, they did the EMMA test.

They demonstrate that in those that they have the abnormal microbiota, dysbiotic microbiota, with all of these pathogens that I mentioned to you, if they give a personalized antibiotic treatment, depending on the type of pathogen, if we have Gardnerella, rifampicin, if we have a Streptococcus, ampicillin. So they can get cured in 25% of them, and in 25%, they still remain the issue, they keep treating. Once the treatment is done and the patient becomes, the microbiota becomes normal, the clinical results that they reported is that by using those study group tested by EMMA, that they have improved this endometrial dysbiosis, then clinical results improve significantly in terms of not only clinical pregnancy rate, but what is most important, the live birth rate compared to the control group.

So this is now the next step in the study of the endometrial microbiota as a small step to improve clinical results. And then, the embryo has to adhere to the endometrial epithelium in order to continue this journey, and this adhesion is key. This is what we call the endometrial receptivity moment. And in fact, the whole menstrual cycle in women has been created just to produce this window of opportunity for the embryo to implant. And it is clearly recognized that this is by changing the cytoskeleton of this epithelial barrier, what we call the plasma membrane transformation. Because the human embryo is able to adhere to any surface that you can imagine: can adhere to the tube, can adhere to the peritoneum, can adhere to this desk, I'm not kidding, can adhere to the plastics.

In fact, we have to repeat many times the embryo transfer because the embryo adhere to the plastic. But the only surface that a human embryo cannot attach is in a non-receptive endometrium. So this is what we have been trying to understand, endometrial receptivity from the anatomical perspective in the past, going to the molecular perspective in the present. And we start more than 30 years ago to understand the transcriptomics of the human endometrium, putting here the transcriptomic Google glasses from the anatomy, learning that this is an objective amount of genes, that this transcription can really indicate us where the window of implantation is. And then we came with this signature of the window of implantation, and we start the test called ERA. And this is done with bulk tissue, the whole endometrium, the whole mucosa of the uterus.

But also, we demonstrate that at the single-cell level, using single-cell RNA technology, and we publish in Nature Medicine, that this is exactly the same. But now we prove this with more than 70,000 cells, 70,000 transcriptomes, and we reach the very same conclusion. Look at the colors, how they change here, indicating that this is the opening of the window of implantation, a situation that we can really identify. And by doing this, we have been able to identify that the personalized window of implantation in the majority of patients occurs after 5 days of progesterone. Progesterone means that ovulation has occurred. So 5 days after ovulation, or 5 days after we give progesterone in a hormonal replacement therapy cycle, in 70% of patients, the window will be there.

But in 30% of patients, the window will take longer or will occur before. And this is the secret of being, doing precision medicine from the standpoint of the moment that we transfer the embryo in the patient. And in some cases, the window will be shorter than we think, such as in congenital uterine abnormalities. So because of that, we launched this test with the surrogate treatment, which is called personalized embryo transfer, personalization, as a treatment for recurrent implantation failure of endometrial origin, the most difficult patients that we have in our field. And the concept was clear: transfer the embryo, not only when the embryo was ready, but also when the personalized window of implantation of your patient is ready.

So this was the test, and we always do when we launch a test, we always have this system of triangulation. In order to look for the truth, we have to have first a biological plausibility, and this is the biological plausibility that I show you, to understand how is that possible. And then we have to go work with the clinical work in pro and con, and altogether, we are looking for the truth in those cases, trying to find specific indications. And for you to understand, if you are not familiar with that, our pyramid of evidence-based medicine goes in these categories. So for us, the maximal category are the meta-analysis that covers all the studies that they have done with the different hierarchies. So what I can offer you for the ERA test at this moment is the publication of two meta-analysis.

The first was published by a Chinese group last year, in which they consider all the studies done about specifically our test, because you must know that ERA test has been copied by 10 different companies worldwide. They changed some genes, but this has been done specifically with the ERA test. This was the number of studies that they have been analyzing, and they basically consider either patients with good prognosis, first attempt, or difficult patients, patients with recurrent implantation failure. The results shows that in those patients with more than three or more than three attempts, personalized embryo transfer guided by ERA significantly increases the chances of pregnancy of non-receptive patients with recurrent implantation failure of endometrial origin. However, for first appointment, for good prognosis, this evidence was not supported.

Similar results were obtained in the second meta-analysis, published this year, by a different group, led by Damián Glujovsky from the Cochrane Database. It takes all the studies published until now, and the results were similar. So you have here the conclusion that, personalized embryo transfer improve, clinical pregnancy rate with this odds ratio and with this clinical, confidence interval and good prognosis patients, they were not supported by the actual data. So somehow finding this indication. So in other words, this test, which is based in the transcriptomic signature of endometrial receptivity using the surrogate treatment of personalized embryo transfer, covers the, personalization in 30% of patients that will be displaced, and we can improve the results on these patients.

According to these two meta-analyses, the indication for this test will be patients, non-receptive patients with recurrent implantation failure. So again, it goes to the personalization. So finally, I just want to show you that in our field, and as in any other field of medicine, we are leading with these scientific innovation phases. One test is happening, once things are just changing, this is not adopted immediately at all. In fact, we were discussing with Bronwyn yesterday that it takes about 30 years to be accepted. I can make you an example of two cases in our field. You have here about PGT-A, the chromosomal analysis of the embryo. This is very simple. It's just to be able to know that the embryo that you are transferring is chromosomally and genetically normal.

Okay, when it came something like 35 years ago, it was the panacea paradise, always, "Oh, wow, that's great! This is going to be useful for everything." Then comes the harmful hell, New England Journal. This is not only helping, but also hurting the embryos, and killing the embryos is not going to work, it's unethical. But then with the time, comes the consolidation period, and this is a HAMA paper showing you that 50%, five zero, of IVF cycles in United States are being done after the analysis, the chromosomal analysis of the embryos, and they have the better results in the world. So this takes a lot of time. And similar feature is happening with the ERA test, but now only with 10 years of life, which is when we launched the ERA test—everything was beautiful.

This was the panacea paradise by which the ERA test is going to solve every problem that every patient that has any type of failure. Then comes the harmful hell, which is the Endometrial Receptivity Analysis. Well, this is not arrays, it's quite old, but this was people that they okay this is terrible.

But with the time comes with a consolidation period, and by now, the only thing that I can offer you is these two meta-analysis, which is the proxy to what is going to happen, by which we have a clear indication of the ERA test in those most difficult patients, that they are the patients that, that need it the most, and those are patients that go from one clinic to the other, and they are about 15%, 10%-15% of our patients suffering this, recurrent implantation failure. So bottom line, my view, and I think that Vitrolife view, and certainly was Igenomix view, is that we have to move forward from the IVF 1.0. What, Professor Edwards created 40 years ago, we have, we have the duty to improve it.

It's not about just to collecting embryos, to collecting oocytes, and transferring embryos back once again and again, and the patient suffering from that. We have to understand better the process to do personalized medicine and to improve all of these parts. What David mentioned to you has been key, but in addition to that, we can do the chromosomal embryo factor. We can transfer embryos chromosomally analyzed and also genetically analyzed, and this will improve and has been shown that at least 15% from the 30% basis that we have nowadays. By analyzing and personalizing the endometrial factor, we can improve. We can move another 15% forward.

So all in all, I think that we are in this line, and by doing so, we will be able to double the digit of success in reproductive medicine, and this will be a big, a big achievement if we can do it through the help of a company like the Vitrolife Group. And with that, I just want to show the faces of the people that they are working with me. I just bring my scientific team with me, and this building is just the next door to Igenomix, from which we still collaborate, as you can see, and from which we are just looking forward to help them in the basic part as much as they want. So thank you very much for your attention.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Excellent. Muchas gracias. So I would like to thank Professor Gardner and Professor Simón. I think outstanding presentations, really helping to set the scene in terms of the history of IVF, the journey so far, but also the barriers and the frontiers that we can and need to cross in order to improve treatment outcomes for patients. So I hope you're feeling as inspired as I feel anytime I get the chance to talk to, Professor Gardner and, and Professor Simón. So we're now going to break for coffee. We will have precisely, and I know Swedes like to be very precise, precisely ten-minute coffee break. So encourage you to mingle, have a coffee, and then we will come back, and we'll take you through each of those strategic pillars that I mentioned, throughout, throughout the rest of the afternoon. So thank you.

Okay, welcome back! Short and sweet coffee break. So we're now going to move into the session of taking you through those five all-important strategic pillars. And I would like to start this session by introducing Mr. Mark Larman to the stage. Mark is the Vice President of the Vitrolife Group Academy, which is responsible for all of the training of embryologists, doctors, nurses, et cetera, that we do around the globe. It has an excellent reputation, and he will discuss our first strategic pillar, which is to own the platform connecting products and services. So I'd like to please welcome Mark on stage. Thank you.

Mark Larman
Vice President of the Vitrolife Group Academy, Vitrolife Group

Thank you very much, Bronwyn. Good morning, everybody. As Bronwyn mentioned, my name is Mark Larman, and I oversee the education and training entity within Vitrolife, and obviously we are very close to our customers, so we're very aware of some of the challenges and the key trends that we have within our field that Bronwyn mentioned earlier today. During this presentation, I would like to highlight some of the main causes of those issues, and then frame how our platform approach, which is in essence, the combination of our current and future products and services, will address those issues. I think you probably got from both of David's and Carl's presentations today, that this is a very exciting and rewarding field.

As an industry partner, we are helping our customers, the clinics, to collect sperm and eggs, combine them, culture them in the lab, and then choose which ones to transfer and which ones to cryopreserve. Of course, there are upstream and downstream parts of this process, but in essence, this is what is being performed in every clinic worldwide, and this is the vast majority of vitrified products are being utilized and where our services are being utilized too. So what does this physical process actually look like? I'll give you a few moments just to look at these images that represent some of the processes that are happening during the IVF lab. You don't have to be the most observant person in the world, but you can see there's a very manual process.

At each stage, somebody is performing a procedure or a physical manipulation. The other thing you can probably see is there are many devices and consumables being used during this procedure. But one of the things that's probably not clear to you is just the fact that you need to be highly skilled and highly trained to perform most of these IVF processes. You're not gonna be able to take someone from this room into a clinic and be able to immobilize a sperm and inject it into an egg with just a few days training, or take a few samples of a blastocyst to send away for genetic testing without ruining the viability of that embryo. So it's an extremely manual process. Takes a long time for these employees to be trained. So how do we overcome this? How do we make this a scalable process?

Well, like many other industries, we need to innovate, we need to automate, and which will also help with standardizing this process. As David mentioned, this is much like an artisan field. If you wanted to put on a spectrum of cottage industry to full-scale manufacturing, it's much more towards the end of a cottage industry. And we're already along and involved in this journey with the EmbryoScope. As David mentioned, it's the specific culture dish standardizes the way that we culture embryos, and as he also mentioned with our iDAScore, the algorithm that's used for embryo evaluation is a much more objective and standardized way of selecting which embryo to transfer. And Dr.

Mitch Rosen will be giving the next presentation, where he'll allude to some of the other key factors that he decided upon when moving towards 100% time-lapse within his clinic. Of course, we need to continue to innovate, both on the EmbryoScope slide. David mentioned his perfusion platform. Maybe that could be introduced into the next version of an EmbryoScope. We also need to innovate across the entire process of IVF to make it less manual and more scalable. There are other activities underlying the physical process of creating embryos. Much like we, as a medical device company, we have to demonstrate that we have full control over our process.

So clinics will have to track consumables, and we'll need to understand what lots of media, for example, are being used within a given time period or for certain patients, so they can go back and troubleshoot if there is a particular issue. They need to ensure that the equipment they're using are being used within their determined specifications, so there's a lot of quality control, even on a daily level. So you'll find members of a team going to pieces of equipment and ensuring that they're running at the right specifications, and that needs to be documented. Quite often, that could just be on a piece of paper and then taken to a piece of software or even a simple Excel sheet.

Of course, the samples, the sperm and eggs, need to be tracked, and the combination of those that result in the subsequent embryo also need to be tracked. We need to make sure they go back into the right patient. And who is performing those procedures also needs to be tracked during the IVF process. And all this information has to go into some sort of database, either a laboratory management system or electronic medical record. And the reason why these have been placed as individual items on this slide is the fact that there's very or even zero integration in most clinics. So they're very individual processes with very, very little communication between them, very little integration. So to make it more of a scalable process, more standardized, we have to bring these together into a platform.

We have to generate an IVF Internet of Things, if you will, an ecosystem, to be able to make it scalable, be able to minimize those manual processes. We are uniquely positioned to be part of this journey. We're uniquely positioned to own the platform by connecting the products and services that we currently have and will have in the future. For example, currently, we, with our current installation base of EmbryoScopes, can perform about 25% of the IVF cycles being performed worldwide, and we also have a very comprehensive portfolio. I would say that the vast majority of clinics in the world are using at least one product or service from Vitrolife. So we are in a unique position to be able to own the platform.

Roman showed this slide earlier, and I think I've been able to at least hopefully convince you that by building a platform, we can help overcome some of these issues. A platform will help to increase IVF capacity and accessibility for our patients. Of course, automation and digitalization will help with the shortage in staff. The consolidation of clinics really requires standardization of the process. And of course, any platform that we develop will consider the regional differences. By increasing the integration and connection of these tools and devices, we'll have much better traceability for our patients, and also much better communication, so they can have real-time process and information of their treatment cycle. So as I mentioned, the EmbryoScope is a very important part of the IVF process.

The embryos spend the vast majority of their time within the clinic, within an incubator, and by placing them inside an EmbryoScope, they are undisturbed. And there are other features of the EmbryoScope time-lapse system which benefits workflow efficiency. So I'd like to invite Dr. Mitch Rosen up to the stage to give a presentation from an end-user perspective on the EmbryoScope. Mitch.

Mitchell Rosen
Professor and Lab Director, UCSF

Thank you. Thank you. Thank you, Mark, for that introduction. As Mark has mentioned, I'm a physician. I'm actually a practicing physician and a lab director, which is quite unique, especially in the U.S., at UCSF. I've been at UCSF for about 20 years, a little bit over 20 years, and what I'm going to talk to you about today is how we implemented or why we implemented the exclusive use of the EmbryoScope. But first, to give you a little information about UCSF, UCSF is a one-site clinic, so that means that we do all of our treatment under one roof. So we see our patients, we do our procedures, we do our embryo work, and we do our storage all under one roof.

We employ about 160 people, and we do about, in total, 3,000 cycles a year. In the U.S., 3,000 cycles is a lot of cycles under one roof. And we are a university, so we're an academic center, so this is an extremely large clinic for a university in the U.S. Our success rates are about 50%-70%, which obviously depends on the embryo that we transfer and the patient diagnosis, but this is among the best in the U.S. And the percentage of PGT that we do is around 50%, which is in line with what the rest of the U.S. does, which is what you've heard in some of the previous talks today. So UCSF wasn't always doing 3,000 cycles.

So in 2017, we were doing about two-thirds or maybe around 2,000 cycles, and at that time, we all got together, and we said, "Okay, we really, really need to grow. We got to figure out a way to grow." But we also knew that we had to become more efficient first, and the reason why we had to become more efficient is because we knew that there were a shortage of physicians, there were a shortage of skilled embryology staff, and in our own space, it was very, very limited. So we had to become more efficient in both the clinical space and the lab space. In the lab, one of the things that or one of the ways that we thought that we could become more efficient is through the implementation of the EmbryoScope, so we decided to trial it out.

Now, one of the procedures that we do most in the lab is we do fertilization checks and embryo evaluation. Here's a video, and you can see how the embryo grows. It's very, very dynamic. We see these two pronuclei. That tells us that this is a normal fertilization. The cells start to divide, 2, 4 cells, 8 cells, day 3. Day 4, they become the morula, and as you've heard several times this morning, this is where we see our beautiful blastocysts, which happens on day 5 and day 6. Now, in a typical embryology lab in the U.S., we would do these checks on the embryo maybe 4 or 5 times, and we have to do these checks at very, very specific time points in order to standardize.

So for an example, we would evaluate this blastocyst at approximately 100 hours. So with every single case, we would be taking out these embryos at 100 hours post-insemination to evaluate. In the US, I mean, at UCSF, we do evaluations four or five times. So we take out the embryo, and we look at it for fertilization check. We do an embryo evaluation and assess the embryo on day three, we assess the embryo on day five, and we assess the embryo on day six.

One of the ways that we thought that we could become more efficient was in order to do these evaluations that I just want to keep this in mind is that we have to take this dish, this polystyrene dish that David Gardner was talking about. We have to take it out of the incubator, and then we have to walk it over to the microscope. We have to look at the embryos, and then we have to bring them back into the incubator. So we thought one of the ways that we could become more efficient with all this bringing in and out is if we eliminate the time that it requires to do all this movement, that we could become more efficient.

Another way that we thought that we could become more efficient with the use of the time-lapse is that we can grade these embryos so much faster. So this is a monitor of an EmbryoScope, and you can see we can actually grade 16 embryos at the same time. This would be something that's impossible to do with a traditional microscope. So, so we decided to, you know, go through this trial with the EmbryoScope, and what we found when we did this, it was much more efficient. So what we had to do is build a business case analysis to the administration and try to prove to them that we wanted to go through the exclusive use of the time-lapse.

So what we did is we first made a calculation, and what we showed was that when we went ahead and we did these two procedures that we were just talking about, the fertilization check and the embryo evaluation, that we would spend on average 2.5 hours a day doing fertilization checks and roughly 20 hours a day doing embryo evaluations. And with the use of the time-lapse, if we went exclusively, that we would only spend about a half an hour doing fertilization checks and around 15 hours doing embryo evaluations, which translated in approximately 6 hours of time savings a day, which is nearly equivalent to a full-time employee. What we also thought of is how we could potentially decrease error and potentially provide an overall safer environment.

So this is a busy slide, but it shows you the foot traffic that actually occurs in the lab. So what happens is that when we do an egg retrieval, we go ahead, we do the procedure, we collect the eggs, and then once we collect the eggs, we have to put them into an incubator, like into a holding pattern, into a ready to go ahead and do fertilization. So then what we do is we take them out of that incubator, we bring them over to an ICSI station, which looks like this, and then we do our fertilization, and then we take the embryos, and then we bring them, or the fertilized eggs, and we take them into the benchtop incubator.

Then once we take them into the bench, put them into the benchtop incubator and we do the embryo evaluations, as I mentioned, we have to take them out of the microscope—I mean, out of the incubator—and bring them to the microscope to do our evaluations, and then we have to take those dishes and bring them back into the incubator. So in a clinic as busy as ours, we're doing roughly 10 procedures a day. We're doing 10 egg retrievals a day. Just imagine the foot traffic that's required to do all of these embryo evaluations. Imagine the potential for error or the potential for having a less than ideal exposure to the embryo. So with the EmbryoScope, there's still a little bit of foot traffic, but it's just significantly reduced.

We still have to take these eggs, fertilize them, and put them in the incubator, but once that's done, we're complete. We're able to assess our embryos, as I mentioned, without moving them. So from that, from the idea that we were provided, we were able to show potentially that we can reduce the error and that we could provide an overall safe environment, and we could actually have that significant time savings, we were able to go to the exclusive use of EmbryoScopes. So what our lab used to look like prior to 2020, if you look at the middle of the lab, you can see all these benchtop incubators, and then you can see our lonely EmbryoScope here, which is our trial.

Now, after 2020, you can see that we've completely eliminated the benchtop incubators, and now we are with the exclusive use of the EmbryoScope. Now, what we didn't notice, or what we didn't know that we were going to be able to do with the exclusive use of the EmbryoScope, is not only were we increasing lab efficiencies, but we got to increase clinical efficiency. As I mentioned, much of the time that we spend in the laboratory is doing fertilization checks and embryo evaluations, and we start that in the morning. It's a morning procedure that goes on throughout the day. Also, in the laboratory, what we're doing is we're doing our egg retrievals, and that starts at around 7:00 A.M. and often goes till about 2:00 or 3:00 P.M.

Then it's only after we get done doing the egg retrievals and the evaluations, where we're able to do the embryo transfers, and we end up doing the embryo transfers starting at around 3:00 and often end at 6:00. This is a very small window in order to do the amount of embryo transfers that are required to do, and it's often not really, or it's not considered a real staff satisfier to stay till after 6:00. Well, knowing that the EmbryoScope is less time dependent, we've talked about that, right? We can dial back, and we can look at any time when, as far as the grade of the embryos, and we know that it's much faster to grade these embryos.

We then switched, we reallocated what actually we did in the day, and now we do our fertilization checks and our embryo evaluations starting in the afternoon, and then we moved our embryo transfers to start in the morning. So what did that do? It enabled us to have more transfers per day, which ended up being a real patient satisfier, and we were able to get our patients out, our staff out much earlier in the day, which became a real staff satisfier. Other advantages or other ways that we've learned to use the EmbryoScope as we've gone exclusive is we're able to train new embryologists because it's very easy to see them. We can just look on the monitor and be able to educate and learn how the embryos are growing, how to match how each of us grade them.

We standardize our embryo evaluations, and importantly, we're facilitating communication between the doctors and the embryologists and the patients. It's a big black box. I mean, these patients are giving us the eggs, giving us the sperm. They're not seeing anything that's really going on in the lab, and then they're coming out with an embryo that we're able to transfer, but they don't really know what's going on behind the door. So by showing what we're able to do through that time-lapse, where the patients get to see it, it gives us a better way of basically being able to communicate with our patients. And of course, with research. So we've been doing a lot of research with the time-lapse. Here's an example of a study that we published with Vitrolife in 2021, where we were comparing media.

We were comparing one media versus the other and seeing through the time-lapse and through morphokinetics, which media was actually better, which was giving us better development. So where do I see the time-lapse going in the future? I see definitely there being more integration with artificial intelligence. I think the combination of the artificial intelligence and time-lapse, we're definitely going to be further increasing efficiencies. How do we do that? Because the artificial intelligence will give us a guide on which embryos to choose which embryos to save, which embryos to transfer. Instead of us looking at each one of them, it'll highlight, and then it'll give us, like, a cue. So it's gonna be that much faster to assess these embryos. And it'll also, as David mentioned, or Carlos, I can't remember, hopefully that more standardization.

I also think that with artificial intelligence, that if we put artificial intelligence together with PGT, we'll be able to get a better combined score and better be able to identify what is the ideal embryo to transfer. How can we, which is the Holy Grail, get the shortest time to pregnancy? Which embryo will get us there? And with this combined score, we should be able to get there much faster. Thank you.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Thank you. Thank you very much, Dr. Rosen. I think this presentation has really demonstrated to us how time-lapse and PGT-A can live side by side, thereby increasing automation, improving efficiency and outcomes. So, a very, very powerful presentation, pulling what I spoke about earlier, pulling together the two threads that I spoke about earlier in terms of embryo evaluation using time-lapse and also then PGT-A. I'd also like to thank you, Dr. Rosen, on behalf of the Vitrolife Group, for being one of the strongest advocates for time-lapse EmbryoScope in the United States, and also one of our biggest users. So clearly, a lot of experience working with this technology in the American market.

So just to close in on then, in terms of owning the platform, connecting products and services, I think clearly you can see that time-lapse is to the core of the play here in terms of the platform. However, we will need to continue to innovate, and we're going to talk about that in a couple of, in a couple of moments. And equally, I do see, we do see as a company, a couple of neat tuck-in acquisitions that would complement this platform play very, very nicely. But we are convinced of the Vitrolife Group's unique position to capitalize and to truly own the platform, connecting products and services. So I'm now going to move us on to our second strategic pillar, which is to innovate, to expand leadership. And I would like to now introduce Jørgen Berntsen. He is our team leader.

He heads up our artificial intelligence team in Aarhus, in Denmark, and he will share his thoughts and his plans in terms of how we can leverage AI to improve embryo evaluation. Please come up on stage, Jørgen.

Jørgen Berntsen
Team Lead of Artificial Intelligence Group, Vitrolife Group

Thanks a lot. Yes, so I would like to continue Bronwyn's talk about how we continue to innovate, to keep on our leadership within the IVF field. I'll be focusing on the AI development, especially we'll focus on time-lapse systems and image-based systems, and then Carmen will follow on by innovations through within the genetics fields. So, a bit of history before we start. So, I was part of the team that originally built the first versions of the EmbryoScope for more than 15 years ago, and we have continued to improve that throughout the different versions of the EmbryoScopes. And it's so nice to see that it's used worldwide, like, for instance, at California and by Mitch, where we have a really, really nice collaboration with them. Initially, we focused a lot on the superior embryo culture.

There's no disturbance, as Mitch told. We also focused a lot of the flexible and the standardized and the much more improved workflow, and that has been the DNA of, of our development throughout the years, ever since I started. Already from the start, we was very focused on the data that was generated by the time-lapse systems, and we had the vision that this data is really going to change the field of IVF. And indeed, this really came true, so now we have a range of different AI products that is based on the data that is generated by the time-lapse systems, and also is, is developed in collaboration with a lot of different clinics. Initially, we have focused on much more simple data-driven AI systems, like the KIDScore models, which are pretty simple, machine learning-based algorithms.

But recently, we have developed the guided annotation and the iDAScore models, which are much more advanced, deep learning-based algorithms that requires a lot of data. And when we're talking about data, we do have a really unique system. So it's, and everybody knows that when you're talking about AI, then data is really essential for both performance, the innovation around the AI. So just to give you a heads-up on that, then, we know that in each clinic, every embryo has an image taken every 10 minutes. And summing this up with all the patients, all the installation we have worldwide, we generate more than 5 million images every day. Another example could be that just I have been standing here for 2 minutes, and in this period, there has been generated more than 10,000 images worldwide.

That is a huge amount of data, and actually, I don't know of any other medical device that actually produces number of images. Each image is then analyzed by our AI, so we also have to focus on making the AI as efficient and so it's possible that it run this huge amount of data. And of course, the data is also essential, when you're talking about continuous your improvement, we need we can collaborate with clinics, we can make new instruments or new AI devices, that we can also continue to improve our six, existing devices. So let's talk a bit about the AI devices as such. We have the Guided Annotation. The Guided Annotation is an AI for embryo evaluation. It predicts the time points of each embryo, so that you can use that for evaluations.

And then it also predicts the blastocyst morphology, which is based on the system that is invented by David, as he just described. So the AI can predict essential characteristics of each embryo, and several studies have shown that these predictions, they perform as good as the human embryologist. And one really nice advantage about this AI is the possibility for the user to validate. So they can check if the inner cell mass, if they agree with the prediction of the inner cell mass, so that they can validate and they can correct it if they don't agree. So it's a kind of collaboration between the AI and the embryologist, so that you'll have... This will both build trust in your system, but it also facilitates a much more comprehensive synergy between the humans and the AI.

Then our second, or the recent, AI system called iDAScore, which has been mentioned a lot of time today. This is an end-to-end AI solution, so it gives you directly a score based on the whole time-lapse sequence. And it's intended to rank the embryos, so that you can prioritize which embryos that you should use first and which maybe you should freeze, so that you have them for a later attempt. iDAScore is based on a patented technology and was developed also in close collaboration with David and the Virtus Health group in Australia. And it's built on a very huge data set that we have in-house, that we have obtained in co-collaboration with a lot of different clinics. So this data set contains of more than 30,000 transferred embryos, and this is really a huge amount of data.

Maybe you can remember that, Mitch was running 3,000 cycles per year. Now, we—this is 30,000 transferred embryos. And we have a lot of independent studies that has been using this AI, and they have all showed really nice correlation between the scores, where low-scoring embryos get a very low likelihood of a live birth, and if you have a very high iDAScore, then you'll have a very high live birth rate. So that really strongly supports our vision of having a healthy baby. Now, we are transitioning, as I mentioned before, Guided Annotation, you could validate your predictions, but for the iDAScore, it's not possible to validate. So that puts a lot of extra demand on our side as a manufacturer of this device. You need to be open and transparent about how you develop your data.

You need to be open and transparent about how you test your data, and that's why we have always prioritized a scientific-based approach, where we openly report the performance of all our solutions, and this is always done with a lot of different clinics. And we believe that only by being this transparent and not over-promising, it's possible for the users to obtain trust in your AI system. Sorry. So, that's why we already, from the first release of iDAScore, has claimed that you don't get any superiority performance of this AI. You do get performance on the same level as a skilled embryologist. However, there's a lot of benefits like Mitch and other has already discussed, like objectivity, consistency, and of course, it's much faster, so you have a much less use of your staff.

Another important consideration when doing AI is the continuous improvement of your system. You need, as a manufacturer, you need to promise that you continue to evaluate your or develop and innovate your models, so that you continuously see an improvement. So looking forward a bit, the sky is really the limit. I don't see any places where you won't have AI is within your software or your hardware medical devices. This is just a small example of things that we are working with today, where you have a raw time-lapse image, and then you have an AI that can identify different structures within the embryo. And this kind of segmentation or AI augmentation will have a lot of different applications within different areas like embryo warming, gamete evaluation, ICSI, biopsy procedures, and etcetera. So that is for sure a fundamental part of our future development.

So there has already now been a lot of discussion about combining, and there, of course, we also, I also see a huge potential for combining AI with genetic information. So, the way I see it is that we have a basis, we have a foundation of a lot of devices where AI is an essential part in some way. On top of these devices, we have a platform that Mark was talking about, that can integrate your data, can collect the data from the AI systems so that it can predict if something is wrong. Could be something wrong in the lab with a lot that is not working, so that you'll have QC.

It could also be that it could see patterns in your, your data that requires that the instrument is maybe updated or some parts of it is replaced, so you could do predictive maintenance. You'll have a lot of additional benefits when you aggregate data, data further up. You'll have a much more good patient consultation, where you can do individualized predictions. And of course, that, that bringing it even further, that's, that's on the way to full automization and especially also giving help to the vision of giving a healthy child. And by, by healthy child, that's we all know that the genetics is essential, so I'd like to pass on the words to Carmen.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

So I would like to introduce our next speaker because she's a very humble lady, and I feel it wouldn't do her justice. So, maybe just to talk a little bit about Carmen Rubio, Dr. Carmen Rubio. She's our Vice President of R&D Genetic Services at the Vitrolife Group. She herself, Carlos spoke about her earlier in the PhD work that she did. She herself is a pioneer in the analysis of chromosomal abnormalities in embryos. As I mentioned, a very humble and understated individual who has had an incredible impact in our industry. And I think the Vitrolife Group is really lucky, or as we would say in Ireland, blessed to have, somebody of Carmen's caliber leading our R&D program in genetic services. So, bienvenida, Carmen.

Carmen Rubio
VP of R&D Genetic Services, Vitrolife Group

Thank you very much, Bronwyn. For me, it's an honor to be part of Vitrolife Group. I'm pleased to be here today to share with you the part of genetics related to the field of innovation to expand leadership. As Bronwyn has mentioned, and also Professor Carlos Simón, the introduction of genetics in the IVF field has allowed us to break the ceiling in the pregnancy rates. With genetics, we are improving treatments, we are improving results in general population, but also in very specific indications. The developments that we are conducting now, we continue to advance in our genetic portfolio with new services and improving the ones that we currently have. They are covering the full reproductive journey.

I wanted to mention that the developments that we are planning are really very well aligned with the different developments that are being done in Vitrolife Group. Also, all of them together, really to go to the vision as a group of Vitrolife Group, to enable people to fulfill their dream of having a healthy baby. Let's start by the preconceptional stage. Very important, as Carlos has also mentioned, we have the patients, we can do genetic tests in the patients, and in the female cell, we have the endometrium. That is really important. Thinking in the endometrium and implantation, EmbryoGlue is also pairing very nicely with the test in the endometrium. Then we have all the development of the embryo and the genetic test that we can do in the embryo. We need a good embryo to do a genetic test.

We need very good culture conditions. We really need good culture medium. We really need the best incubator to work with this. And then finally, we want to do the follow path of the IVF cycles that we are doing. We want to follow path pregnancies, and we have developed non-invasive tests for prenatal testing of ongoing pregnancies, and also for the product of miscarriage when there is a result that is not the one that we want. And what is this bringing to all of us, all this genetic data that we are collecting from all the reproductive journey? At the patient's level, at the clinician's level, all this genetic data is empowering clinicians for personalized treatment of the patients to really choose the best treatment for better clinical outcomes. At the embryo level, we are learning a lot how to improve embryo evaluation.

Why we want to evaluate embryos? We want to select the best embryo for transfer for the first attempt. The important goal that we have in IVF is just to have successful results in the first attempt, not just after several trials, or to identify at the very first attempt, the very best embryo. This is really, really important. How are we basing our R&D plan for the next years? We consider that the main drivers of innovation in reproductive genetics are going to be driven by the technology. The technology has evolved, and as Carlos mentioned, we can go from chromosomes to single genes, and now whole chromosome, whole genome sequencing or whole exome sequencing. For sure, from invasive to non-invasive genetic testing, we want more patient-friendly treatments, and they are going to give our patients higher, and clinics higher accessibility and affordability for the treatments.

Also, as I mentioned in the previous slide, with all this genetic information that we can collect on the different steps, we can really can have an holistic view of the patient and the embryos for improving clinical outcomes. Starting with the technology, this is how we have moved in the last years with the application of genetics to the reproductive field. Starting by checking chromosomes, chromosome number, karyotype, point mutations related to genetic diseases, and now we have the whole spectrum of genetic information, whole genome sequencing and or whole exome sequencing. How these technologies has evolved? Initially, these technologies are always applied at the patient level because we can do a blood test, we can test thousand of cells, and then we need to improve and to refine the technologies to be applied at the single cell level in the embryo.

And we are in this mood. So we have been able to translate many of these technologies to the analysis of the embryo, and we keep on working on that. So we can have also a more comprehensive information about the embryo, to have a baby, but also to have a healthy baby. That is our main goal. So let's start by the patients, and as we are all mentioning today, patients are at the heart of everything we do. And we know that genetic testing, as Carlos mentioned, is very important because we can be carriers of a genetic mutation, and then we can have a disease if we just match with another carrier of the mutation.

So it's important to test the patients or to test all of us before pregnancy desire, just to see if we can have a risk of a genetic disorder. But genetics are also involved in some of the conditions that are related to infertility, that we can maybe not consider a disease, but can result in some infertility problems. And that's why we have started to incorporate the analysis of genes that are really very well known and scientifically shown that they are related to some genetic conditions affecting fertility. And why is this important before I started the treatment? Because we can anticipate if one treatment is going to be successful or not in the couple. So this is the spectrum of the genetic testing that we are applying in couples, in the male and in the female cell.

In the female side, we have to consider also the endometrial health. As Carlos Simón has mentioned, we need to consider that the couples, we need to understand how to test them. We need to understand how the embryo is, but in the patient, before starting at the preconception level, we can also test if we have an important problem in the place in which the embryo is going to grow. The endometrium, as mentioned, is a key player for successful implantation, and we are considering the endometrial receptivity and the endometrial microbiota, as Carlos mentioned. An example of the studies that we keep on doing to reinforce the position of the endometrium in our field is this non-selection study in patients with implantation failure. Again, identifying the patients that can really get the benefit for the test.

So the aims of this study are to increase the scientific evidence of ERA in this particular indication, patients with previous implantation failures, to previous implantation failures without chromosomal testing or just one failure after the transfer of a chromosomally normal embryo that fails. Also, we want to keep on advancing in the knowledge of the endometrial health, considering other aspects, not only endometrial receptivity, but also analyzing immune and metabolic alterations that maybe can have an effect on implantation. And finally, has been introduced by Carlos, we want to work in more patient-friendly treatments, so non-invasive EMMA in endometrial fluid, to be able to test the microbiome without the need of an endometrial biopsy. So in this study, we are incorporating more than 700 patients. We are collaborating with 9 clinics all along the world.

I have to say that thank you to the many clinics that are always willing to collaborate with this for the studies. They are really great partners. In the patients, we are going to do the endometrial biopsies. We are going to collect the endometrial fluid. All the embryos are going to be tested by PGT-A, so we are sure that we are controlling the embryo side. Then we are going to do the follow-up until pregnancy, to 12 weeks, and also live birth. The idea of this study is really to reinforce the position of ERA in the recurrent implantation failure patients, and also to move to these non-invasive approaches that we want to incorporate in all of our genetic tests. Moving to the embryo, the other key player. We really believe that we can have a non-invasive test for the genetics of the embryo.

We have been pioneers in this field, identifying the presence of small fragments of cell-free DNA that can be released to the medium. Just by analyzing the medium, we can have reliable information of the chromosomal contents of the embryo without the need of a biopsy... and we have a unique position now at Vitrolife Group of combining all of what we have learned about genetics with imaging. The world is moving towards non-invasive. We can combine imaging with the analysis of the cell-free DNA. Genetics are evolving, so we can see the future with a combination of the best of genetics and the best of imaging, that we are going to have new generation of genetics, new generation of imaging, for sure.

This is the last slide, and we have selected this slide as the final slide because it really summarizing the collaboration that we are having inside Vitrolife Group with the idea of working together to improve IVF outcomes. In this study, we are working with eight clinics all around the world, with the idea of having EMBRACE cycles, patients undergoing the chromosomal analysis of the embryos in a non-invasive way, and all the embryos incubated in an EmbryoScope incubator. We are providing the clinics with the latest innovations in artificial intelligence, so we have a strong support for our team of technology. The idea is to collect as much information as possible, just to be able to use artificial intelligence to better predict the health of the embryo and the possibilities of having a successful result.

But not only that, because if we want to have genetic testing in a very automatic, automated way, and if we want, if we want to optimize our workflows, we really have the system to do it. So this study is also allowing us to improve how to work in the IVF lab, to go through a workflow that can make genetic testing more automated and more, in this case, embryology-friendly, more useful for embryologists. And that's all. Thank you.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Gracias, Carmen. So I'd like to thank Jørgen and Carmen. I hope, and I believe that this further demonstrates the Vitrolife Group's commitment to innovation and to bringing further tests, products, and solutions, most importantly, that positively impact the patients to the market. We are now going to move to our third strategic pillar, which is accelerate growth in key markets, and I would like to invite a proud Gothenburg native to join us on stage. Rickard Ericsson is our Senior Vice President of Sales and Marketing, and he will lead the accelerate growth in key markets session. Welcome, welcome on stage, Rickard.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Thank you, Bronwyn.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Mycket bra.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Mycket bra." Super. Hello, guys. You still awake? 20 minutes, then it will be lunch. This is going to be a little bit different than previous sessions, so it's going to be a lot of fun, as well as the previous. We are going to be exploring together the market trends and dynamics that is shaping the industry of today. I would like to start with basically some of the data that Bronwyn shared earlier, because repetition is the mother of learning, right? If you look upon the global IVF market, there is roughly 4.5 million IVF treatments conducted annually. 15% of those cycles are done in the Americas region, one-third in EMEA, and more than 50% in APAC today.

We're looking at a rough organic growth in volume of 5%-6% annually, but that will be taking off when we see affordability increasing. Automation will increase; then, of course, IVF numbers will be accelerating. If we look upon specific countries, again, here, based upon what you said, Bronwyn, 25% of the cycles today in volume are in China, 12% are in Japan, and roughly 9% is in the US market. But if you look upon the value of IVF, the biggest market in value is the US. And how come? Well, more than 50% of the treatments in the US market are paid by the patients out of own pocket, and they're paying roughly 4-6 times more than anyone else in the world. So that is driving the value.

If you look upon reimbursement systems, we will hear soon, Dr. Kato talking, but there is a new reimbursement system introduced in Japan that is driving volumes, roughly 10% addition on previous organic growth due to the reimbursement system that came into place April 2021. China are currently looking at implementing reimbursement system, so they're running a pilot in Beijing province, and if that is successful, they will replicate that in the other provinces. In the European market, most of the countries is having one reimbursement system in place in one way or another, and it's the U.S. market where we'll start to do exploration soon. So Dr. Rosen, please get prepared.

As Bronwyn said again, here, we have a very nice and even divide between the markets when it comes to revenue generation, and we are looking at now investing quite significantly into our footprint, our presence in the US, because that's the market where we want to be accelerating our sustainable growth even further than in many other markets. I've been asking three external experts to help me to paint a picture of the market dynamics in three respective geographies. We will talk about the US market with Dr. Rosen. We will talk to, we will listen to, actually, it's prerecorded, Mr. Eduardo Gonzalez, who is the CEO of the Eugin Group for Europe and for Latin America. He will talk about the European market and its evolution in the future. Then we will listen at the end here to Dr.

Kato, who is the Managing Director of Kato Ladies Clinic in Japan, the biggest clinic chain in the Japan market. So if I can please ask Dr. Rosen, are you willing to join me on stage here?

Mitchell Rosen
Professor and Lab Director, UCSF

I don't know.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Oh, yeah. Let's do it.

Mitchell Rosen
Professor and Lab Director, UCSF

All right.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

And please, if there are some questions that is popping up in your head now, scribble them down and ask them to Dr. Rosen-

Mitchell Rosen
Professor and Lab Director, UCSF

Yeah.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Potentially in the Q&A session, right? The first question, Dr. Rosen, here, I have a difficulties. So if we look upon the current trends and changes in the U.S. market and take a focus on affordability, because as I said, more than 50% of the cycles in the U.S. are paid by the patient out of their own pocket today, and the treatments are very expensive. What is being done, as you see it, in the U.S. market to improve affordability?

Mitchell Rosen
Professor and Lab Director, UCSF

Yeah, it's a very good question. As we've mentioned many times over today, access and affordability is a huge issue in the US, and I think one of the ways that we're going to be able to control that is through more and more insurance coverage. We've already seen over the last five-plus years that there has been, where we've seen probably around 20% insurance coverage about five years ago. Now we're seeing about 50%, and that's starting to really constrain the cost. I think we'll see a relative ceiling there because of insurance coverage. But then as a result, what's going to have to happen is, the clinics are going to have to figure out a way to become more efficient.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

A good thing for the IVF treatments, they will be going up to the same extent the clinics are needing to be caring very much more about their wallets. That's why automation and innovation will come into play.

Mitchell Rosen
Professor and Lab Director, UCSF

That's right.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

If we then talk about this, this shortage that is also present today in the U.S. market with doctors, embryologists, nurses, lab directors, how is that impacting capacity and accessibility?

Mitchell Rosen
Professor and Lab Director, UCSF

It's a good question. I think as far as the US, there are data that suggests that the US should be doing 10 times the amount of cycles that they're doing now to meet the actual needs. And as far as from a physician perspective, there is a real shortage because we're only graduating about 50-60 new physicians a year. So that's certainly not going to meet the needs. There's a couple ways that we could probably figure that out. We could probably shorten the amount of time it takes to graduate a physician. Currently, it takes about three years on top of medical school residency and then the fellowship to sub-specialize, so we could probably shorten maybe that a year. That might help things.

But I think the main way we're seeing it happen, right now, is through the use of physician extenders. And then, of course, if we have artificial intelligence and automation, which is what we're really looking for right now, we'll become more efficient. As far as from an embryologist standpoint, there's an extreme shortage. In the U.S., we don't have real training centers. I mean, we have a very small portion of them. Some of them are very internalized for the given PE groups or large networks. So most embryology training is an apprenticeship. So they come into the lab one at a time. Most labs don't have time to train them, so there's become an extreme shortage there, too.

So again, artificial intelligence, automation, both these are going to help us become more efficient inside the lab.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

If we take a look into the future, I think question number two is behind me, right?

Mitchell Rosen
Professor and Lab Director, UCSF

Yeah.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

and you mentioned the PE-owned networks.

Mitchell Rosen
Professor and Lab Director, UCSF

Yeah.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Today, as you know, roughly 50% of the cycles in the U.S. are under the remit of the networks. These guys, they would be looking for scalability. They will be looking for maintain profitability. What do you think will be in their focus to be able to ensure a good and successful future for them?

Mitchell Rosen
Professor and Lab Director, UCSF

Ah, they're-- we're going to continue to see that consolidation. I mean, we're even seeing that consolidation, these networks buying up university clinics. That's just unheard of. And they're internalizing their PGT, potentially, and all of this is helping them with economies of scale. I think they'll also figure out ways to control costs as it relates to labor, and of course, they'll be looking again at technology, digitalization, artificial intelligence, automation, every which way they possibly can to become more efficient.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

The next question is more about the patients, the individuals that we're ultimately wanting to be helping to get the healthy babies. What is the main, let's say, choice? What is making the patient go to UCSF instead of the neighboring clinic today?

Mitchell Rosen
Professor and Lab Director, UCSF

Oh, that's a great question. I would say, you know, 15 or 20 years ago, they were really looking for the physician. I mean, patients would wait 3 months, 6 months to come in to see the physician. Right now, it's not that way at all. I mean, they're really looking for access, how quick they can get in. They're looking for the patient experience. They're looking for access to data. These patients, I want to mention, are really knowledgeable. I mean, they're coming in telling us the treatment that they want. They're going to Google, they're becoming the doctor, and it's really becoming way more transactional. "This is what I want," not coming to the physician with their expertise. So it has really changed over time.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

They are kind of do their own type of personalization-

Mitchell Rosen
Professor and Lab Director, UCSF

Oh, yeah

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

- even before having the first discussion with the doctor.

Mitchell Rosen
Professor and Lab Director, UCSF

That's right.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Next question.

Mitchell Rosen
Professor and Lab Director, UCSF

Mm-hmm.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Yeah, now you have the opportunity, Dr. Rosen.

Mitchell Rosen
Professor and Lab Director, UCSF

Hmm.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

What are the requirements that you're putting on IVF partners, like the Vitrolife Group, to enable all these changes that needs to happen in the U.S. market?

Mitchell Rosen
Professor and Lab Director, UCSF

Well, I think customer service is paramount.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Uh.

Mitchell Rosen
Professor and Lab Director, UCSF

I think you do a good job of that.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Thank you. Thank you.

Mitchell Rosen
Professor and Lab Director, UCSF

But I do think that really what we need to do is, integrate. We need integration. That's super important, at least over the short term, of all of the equipment and so on, because I think that's going to continue to, make us more efficient. I was mentioning yesterday that right now to help us, because as we've increased in growth, we've now hired six administrative staff to just handle the manual entry of all the data that's coming in, for which we didn't have to do five years ago. Just to enter, and not have to hire and, more embryologists. We take the embryologists, delegate them to doing what they do best, and then just hire six administrative staff to just manually enter. So I think integration would be super important.

And then over the longer term, as we've mentioned over and over again, I think it's the automation. I think it's the artificial intelligence. I think it's both those that are going to help us. Both of these things will help us become more efficient.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Thank you.

Mitchell Rosen
Professor and Lab Director, UCSF

Yeah.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

I think you actually answered the last question there, because if we look upon the areas of most interest, as I would see it, and based on what you have said already, Dr. Rosen, for innovation short term, it has to do with automation, technology adaptation, making sure that data is then flowing more seamlessly between patients, the clinics, within the clinics, and that requires quite a lot of investments in digitalization.

Mitchell Rosen
Professor and Lab Director, UCSF

Yes, I agree with that also. Definitely. I mean, I think the Holy Grail is pregnancy, right? We want the shortest time to pregnancy. We want to increase pregnancy. Carlos has talked about that. David Gardner's talked about that. And, you know, we can probably or maybe achieve that somewhat through science, but if we get automated and we improve on our standardization, we're going to be able to see these differences in science, where we can poten- it'll be potentially easier to see the difference in pregnancy outcomes that we're achieving through science. Right now, there's so much variation, physician to physician, embryologist to embryologist.

As David mentioned, there's a lot of subjectivity in how we grade the embryos, so which embryo do we pick is varied, depending on the embryologist, and this standardization will put us to a common level field, and we'll be able to see this stuff, that's the science that's going to help us improve overall pregnancy rates. Also, I think that just the automation is going to rise the tides. I mean, as I mentioned, all this variation leads to maybe some variability in the pregnancy rates. So if we standardize, I think the tides will rise. Pregnancy rates will just increase through that.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Thank you so much, Dr. Rosen. Now it's time to move on to the European market, so-

Mitchell Rosen
Professor and Lab Director, UCSF

Can I-

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

You can

Mitchell Rosen
Professor and Lab Director, UCSF

... start? Okay.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Yes.

Mitchell Rosen
Professor and Lab Director, UCSF

Whew!

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

Thank you. What we will do soon is that we will show a little recording of an interview we made with Mr. Gonzalez. For those of you that follows, let's say, the consolidation movements in the IVF space, Eugin Group was one of the biggest chains. They are still one of the biggest chains, actually, in the world. But the North American side of Eugin Group was acquired by IVIRMA. IVIRMA is owned by KKR. The European side and the LatAm side, for which Gonzalez is still the CEO, was bought by GED Capital, another PE company, and these two PE companies are actually collaborating, so it was a creative, let's say, solution, as they said themselves in the press release. Anyways, let's play the movie of Mr. Gonzalez.

Eduardo González
CEO, Eugin Group

Me too, to this representation and to give me the capacity to give my ideas on the performance and the outlook for the European market. As I said, I've been seven years working in the IVF industry from a finance background, so I'm not a doctor. I'm not an embryologist myself. I'm a businessman working in different fields over the last whatever, 30 years. As I said, seven years in the fertility industry, growing up a group, which is the Eugin Group, currently present in Europe and in LatAm. So I think one thing that we have noticed over the last couple of years is a bit of a decline in the birth rate on some of the developed countries.

You know, like, less children being born out of a natural process. That's kind of also affecting fertility in a sense, because, of course, that's our main market. However, that's more than compensated by the increasing penetration of fertility services into the European countries. On the market itself, we see increasing penetration of fertility services. Of course, and we've been kind of part of that process, increasing concentration in that market out of you know, buildups, particularly led by private equity, big private equity, with a lot of interest in the European market. We have also seen, which is very important, an increased control from central authorities. So it is true that it's a trend of you know, governments allowing for more and more types of treatments in individual countries.

We are adopting new family types that also pushes us to be more elastic in the way we approach this market. We also see a lot of interest from different authorities, different governments, into promoting birth rates, right? That's been done through more support to fertility services through public systems. With regards to technology, we see a lot of automation coming in. We are all embracing, of course, the AI technology, digitization. If we combine, you know, what we have seen or what exposed us, you know, trends currently in the market, and to add to that, we are at a continuous decline in the access to resources for clinics. And I'm not talking only about doctors. I'm talking about doctors, I'm talking about nurses, I'm talking about embryologists.

Like, all that human resource management is becoming extremely difficult, and most of them will try to be less doctor-dependent. Also, as a result of the lack of resources on the human resources side, we see a lot of automation coming in and lab concentrations. We will all trend to concentrate all those labs into bigger labs, more automated, less people-dependent, in the increase of penetration of genetic testing services and also donation treatments, and those two are also very much linked. I think there still is a bit of disconnection between the way genetic testing is going and the way fertility is going, with regards to anonymity and, you know, the things that you can do from a genetic testing point of view.

I think we need to work together on that to make that more intrinsic, more working together. You also have to be, as I said, adopting new devices that can take part of that treatment that has been currently executed in the clinics to the home of the patient. Those devices need to be linked to your own systems, to your lab, to your doctors, and for that, you need a lot of digitization as well. Everything related to technology and automation in the lab. So automation on bigger labs, and also the adoption of new equipment and new techniques that will help us to be much more efficient in the lab, and that we can do more volumes in bigger places with less staff. The empowerment of our patients, yeah?

I think at the end, that's what, what really matters, and we have to be responding and anticipating. We have to really be very specific on every treatment. Every patient is completely different, and we have to be able to, through technology, mainly, customize, personalize that treatment to every single situation. You need a very well, good automated lab, where you have very consistent success rates, but at the same time, you have to be extremely flexible on how you are responding to the needs and requests from your patients. That's number one. And number two is, I think, completely focused on the patient journey. I think the patient journey has to be revised.

I think we've looked at it up until now from the eyes of a clinic, but we have to look at it from the eyes of the patient. The key thing here is to have a very agile organization that is capable of adopting new technologies that are, as I said, very patient-oriented, as fast as we can, because this will be continuously moving. On the pricing, bringing in or coming in this, you know, this elasticity that it is not currently in place, I think we have to be much more dynamic in the way we organize pricing, also related to the customization of our treatments, the personalization of our treatments. That is key today, and will be still key in the future, is the affordability of those treatments.

To shorten as much as possible the time to reach that, you know, newer stage in the industry, that maturity stage in the industry, and then to do it in the most efficient way. For that, I think cooperation is the word. The endpoint of the industry is a certain endpoint, and we see the trends, and we see where we may have some difficulties, that we talk openly about it. One will be co-development. We all have to cooperate and work together because there's something, some stuff that providers are missing, but there's a lot of stuff that we as clinics are also missing. You know, sometimes it is access to technology, sometimes it's a too narrow view of our field. Second will be a co-investment.

Co-investment, and I'm not talking about money investment only, probably. I'm also talking about brain investment, human resources investment, commitment investment. I think by creating things together and committing investment together, in that sense, in that broad sense of investment, I think that's the guarantee for things to happen. Third one is have an integrated vision of the industry. It has to be with a long-term view. You know, certain things take a lot of time to be developed. And you know, sometimes strategies of the companies change or even ownership. That view, combined picture of what the industry should look like, that should be kind of leading the whole process, and that should give us that comfort that even those changes will happen, for sure will happen.

Still, that long-term view is still sitting there on that, on that combined picture. Yeah. One will be automation. Automation related to lab work. I think there are still many steps in the process of doing an IVF cycle that are human-dependent. I think we have to find a way to get away from that one, because, you know, if you combine that with a lack of resources, then we might be facing an issue of an industry that is being, you know, used to always improving success rates, maybe a decline because of the lack of resources. So we need to replace all that by good automation and good processes sitting in the labs. Genetic testing. I think there's still a lot to be done on genetic testing.

I think it has to be much more integrated, because this is the first time that you get access to genetic information of a gamete. And as you know, you know, this will evolve, and I don't know what's ahead of us. The access to that information is absolutely mandatory as early as possible in the field, and we are the first one on the step. Yeah. So if we get the information there first, then I'm sure that will have a lot of added value, and there's a combination. We have to work together on that. You have to provide those solutions because you have to facilitate that patient journey, and that goes also through devices. Last but not least, AI.

We have to use AI efficiently, to improve the patient journey, to improve you know, the customization of our treatments to our patients, and yeah, of course, to you know, do some cost savings and stuff like that.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

So there was quite a lot of interesting messages sent, I think, from Eduardo to us all who is in the IVF industry. There are similarities between the U.S. market and the European market in many aspects, but there are also key differences. In the European market, with quite a lot of reimbursement systems in place, are not really suffering as of yet, let's say, from affordability, but they are looking for more procedure sets to come into play, like, for example, genetic testing, as heard from Eduardo, which is not as highly prevalent in the European market today as in the North American market. It will definitely be so that the same type of shout-out for the need of automation, standardization to drive efficiencies, digitalization, you hear that from both Dr.

Rosen as well as from the CEO of the Igenomix Group, and that is one of the responsibilities for the Vitrolife Group, to make sure that these tools are being developed, let's say, not only for the bigger chains, but the individual clinics, to make sure that we can actually be doing IVF much more efficiently, tend to many more patients in the future, et cetera. I will conclude and summarize what we've heard after the last interview, and that one will be with Dr. Kato. Again, he's the managing director of Kato Ladies Clinic. That is the biggest clinic chain in Japan. So please.

Keiichi Kato
Managing Director, Kato Ladies Clinic

Good afternoon, everyone. My name is Dr. Keiichi Kato, Kato Ladies Clinic, in Japan. My center is specialized for the IVF treatment, and also the focused on the minimal stimulation, not the hyperstimulation. Embryonic genomics field, including PGT-A and time-lapse monitoring systems. Now is 100% introducing a time-lapse system using Embryoscope and the EmbryoScope Plus. In Japanese IVF market is now is very dramatically changes, such as Japanese government introducing a social investment system for the IVF field. In that changing, that treatment cost for the patient is about 30% compared to the previous. And then the young patient able to take IVF treatment.

That is very important for Japanese low birthrate situation. I think in this point of view, that government trial is successfully proceeding, that treatment cycle is increasing compared to the before, about roughly 10% before the insurance system. Introducing insurance system is good for the patient in that point of view, but that system is only covered basically treatment. Some patient, such as old patient and multiple failure case, that patient need to extra option not covered the insurance system. But in Japanese law that is not allowed to combine with insurance system and self-pay treatment. So that the balance of the choosing of the option is difficult and important to the patient and the IVF treatment doctor.

Yes, that important point is two things. The one is how to ensure to get pregnancy such as a young or normal patient to the regular treatment. And that almost all treatment is covered the investment systems. So under that area that patient cost of the treatment is safe. On the other hand some patient such as old and recurrent failure case need to special treatment, and that special treatment is not covered the investment system, and not so many evidence. So we need to try day by day that introducing that new technique and that treatment option. Yes. For the short-term period is stable apply your product.

Because of recently, many other product and medicines are suddenly stopped to the apply. In that situation is that is complicated to the patient and the IVF treatment facility. And also, the long-term period needs to setting up a high evidenced clinical study for introducing difficult or recurrent failure patient. Because of the the for investment system need to evidence to the setting up new treatment. So we and Vitrolife collaborate to need to setting up a a good clinical study. Yes, one is more advanced to the PGT-A treatment. The more high accuracy analyze aneuploidy and low damage to the embryo, such as non-invasive PGT-A, your product names, EMBRACE.

For the IVF field, such as endometrium thickness and low ovarian reserve case is a severe problem.

Rickard Ericsson
SVP of Global Sales and Marketing, Vitrolife Group

So in summary, there are differences, as you might spot here from the interviews. If I try to conclude a bit, relating to the mega trends that we are seeing in the markets in general, but also what needs to be done. If we look upon accessibility, as you hear from these guys, in the U.S. market, insurance coverage will be increasing. That's a good thing for affordability for the U.S. patients, without any doubt. Today, 45% is covered by insurance. It will increase. That's a good thing. In Japanese market, as well as soon, hopefully coming in Chinese market, in the European markets, we have reimbursement systems. These guys are asking for additional procedures that to be covered by reimbursement. For that to happen, for example, in Japan, you need to have the clinical evidence.

You need to be able to show that this has a relevance for the patient, then it will be added to reimbursement system, and that's a shout-out basically towards us in the industry, "Help us to provide this evidence," and then reimbursement systems will be broader in coverage, and that will facilitate for better treatment outcomes. Same kind of message was sent by actually Eduardo when it comes to European market, a broadening of the coverage of the reimbursement system. Capacity is a different thing. Capacity is both the fact that we are today suffering in all parts of the world from not enough staff, not enough doctors, not enough embryologists, not enough lab directors. We need to tend to that together with the clinics through automation, digitalization, and standardization, so we need to be innovation to the field without any doubt.

Innovation, this was quite, quite important from the message from Eduardo. This is something that needs to be done by the providers of products and services, like the Vitrolife Group, together with the clinics. It was cooperation, co-development, co-investment, having the same vision with the patient in mind, making sure that we want to do the greater good for the patient ultimately. We need to work together to be able to realize this, and we are, as I will show after lunch, in that position today to support each other, to take the industry forward. Standardization from consolidation, yes, the PE-owned, of course, clinics will be expecting scalability. They will be expecting standardization. That's evident. That's what's going to happen. Then, of course, he talked about mega labs, you know, putting bigger, bigger labs together, like a hub and spoke model.

Basically, the doctors will be in satellites. The labs will become bigger. That will then allow scalability and efficiency in actually running the labs, but still you need to be accessible to the patients. That's why we have hub and spokes, so the doctors might be more out there in satellites, consulting and talking to the patients, while the labs will be running much more optimized through new technologies. Regionalization, I will not cover now, we don't have the time, but patient empowerment, I think is very important. Personalization, Dr. Carlos Simón, and you mentioned that previously. It was a definite shout-out as well from Eduardo. We need to make sure that we don't tend to each and every patient in the same way. They're all different.

So in order to be able to do this, we need to have different tools in the toolbox, different procedure sets, to make sure that we can actually personalize to the individual's requirements to be successful in the outcomes. And then, of course, affordability and broadening, let's say, the availability of procedures will be key for the patients as well. There was one mentioning in here of home treatments. That is still in its infancy, actually, but it will be so that certain parts of the procedures can be supported by patients doing things on their own device, in their own homes. That requires the connectivity between the patient and the clinic, that is then digital as well.

So digitalization is not only what we provide the clinics to have a better experience with working with us, what the clinics are needing to do to secure seamless data flows and EMR integrations, is also patients that needs to be connected to the clinics. With that, that was my last slide before lunch. How are we doing in terms of time? Can we do 30? So it will have to be 30 minutes, sorry, guys, for lunch. And if you do have the time, please pass by, pass by the marketplace. Otherwise, you can do it after the sessions end today. So lunch is served outside here, where you had the coffee, and we'll see each other again in 30 minutes. Thank you so much. Are we ready to go? It's a good thing that you're enjoying the marketplace.

There will be plenty of time after the sessions as well, so if we can get seated, thank you. Okay, how was lunch? Was good? Super. I will now take you through the fourth strategic priority of the Vitrolife Group. This one is all about us on a continuous basis, wanting to be able to serve the clinics and the patients in a better and better and better way. I will try to describe to you what we are going to do, what we are doing, and the ambitions for the future in that regard. I divided this section into three distinct areas. In the first one, I think this will be really interesting for you guys to listen to. It's actually the tangible synergy effects that we're realizing from the acquisition of Igenomix. That will be topic number one.

In the second topic, I will talk about what makes us, the Vitrolife Group, different than competition. How come that we perceive ourselves to be better, stronger, in a better position to serve the market moving forward than anyone else of the providers of products and services? In the third section area, I will talk a little bit about the solutions we are putting in place to improve the efficiency of the communication, interaction with the clinics and the patients, for that sake as well, in the world through digital solutions. But let's start with the first one, the tangible synergy effects from the acquisition of Igenomix.

Most of you would know Vitrolife since many years back, I presume, and you would know that the Vitrolife side of things has got extremely strong products, high-quality products with unique spearheads, such as we have already heard today, the EmbryoScope time-lapse system. We got the antioxidant media, we got the transfer media that Professor David Gardner talked about when it comes to EmbryoGlue. We've got strong, high-quality oil, we got the Sense needle, we got labware products that is unique in the marketplace. With the acquisition of Igenomix, we got the leading genetic services provider in the world. That, to me and to us, is a massive spirit in its, in its own device. Beyond that, we also are offering laboratories that wants to do their own testing with Vitrolife genomic kits.

So we believe firmly that we have a very strong portfolio to stand on today, and that gives us a fertile ground, actually, for future innovations. As you heard today, we are going to be focusing these innovations in realizing automation, realizing digitalization, making feasible for standardization, and so forth. In the platform presentations in Innovate for Future Leadership, you got a little bit of a feel for the areas we are looking into to enable all these aspects. The second point here is with the acquisition of Igenomix, again, we got access with local people to many, many more markets than what Vitrolife used to have in the past. Of course, we have a big beneficial effect out of that because we are much more accessible to the clinics.

We are there and can service them in a stronger way than ever before when you only go through distributor partners. This does not mean that each and every indirect Vitrolife market will be turned into a direct market. Some we have turned into direct markets already this year. We will be doing that in Spain and Portugal as of first of April, for example, but we can also leverage the local footprint of Igenomix staff to be servicing our distributor partners in a better way. And together with our distributors on the Vitrolife side, we can jointly go with the full portfolio that we offer to the clinics. So everything is not about turning each and every market indirect to direct.

Some markets we are doing it, others we are evaluating, but we also get a much stronger connection with the Vitrolife distributors by the local footprint of Igenomix. The third point here, Igenomix has got very strong relations with doctors across the world. Vitrolife has got very strong relations with lab directors and embryologists. When you combine that, that we have access to each and every key stakeholder in a clinic with a very strong offer, that we are then, of course, looking at innovating, innovating, innovating, we now have the opportunity to be tending to all individuals in the clinics that is going to making decisions, what to use when it comes to products as well as services. So that is, to us, a very strong enabler for the future. The second part here, I've already said it.

In the core of our value proposition, we got high-quality products and services with unique spearheads. That is without any doubt the fact. When we're looking at innovations for the future, we don't innovate only on our own device. We have a lot of collaborative research and development initiatives, and you've heard many of the speakers here today with whom we are collaborating on a daily basis. Of course, Dr. Gardner, Professor Carlos Simón, Dr. Kato, for sure, Mitch Rosen, et cetera. And this makes it possible for us to make sure that innovations for the future is built upon real market and real customer requirements, not only what we can do technically, but we are then, of course, co-developing and co-innovating, as Eduardo mentioned previously from the Eugin Group.

Besides that, education and training, with the lack of individuals in the clinics, all the way from doctors, embryologists, and lab directors, we are needing to make sure that the competency level with the ones that are working in the clinics are at their highest possible level. With that, we're using the Vitrolife Group Academy, with Mark Larman, Jaco, Nasser, and others, securing education and training, both face-to-face as well as online, that I will show you, show you soon. Besides this, on a daily basis, we got, what I call clinical support individuals in many, many markets of the world. These guys work on a daily basis with the clinics to optimize procedures, to secure that the products and the service are used in the best possible way to get the best clinical outcomes for the patients.

So we got a very strong competency when it comes to providing that type of support to the clinics. Claus will talk a little bit later regarding technical support, because with all the equipment that we're providing the customers with, we need to make sure that this equipment is always up and running, that there are no failures, they don't go down. Time just needs to be there, ticking around the clock, and that we do through our technical support team, which Claus will come back to. Last but not least, I'm extremely proud of the customer support and customer service individuals we have in the organization. They also work locally. In each and every market where we have a local footprint, we've got a customer service team on the Vitrolife side and/or a customer support team on the Igenomix side.

These guys, and you heard it as well from one of the interviews, if you cannot provide your products or your services, it doesn't really matter how good they are, right? So we need to, at all times, make sure that the products and the service are available continuously with steady supply. And that is very much being done by our supply chain organization distribution, in combination with customer support and customer service. Then you might say, "But what makes you different than competition? Everybody can say this." Well, I've only been for nine years with the company, but I can assure you that we know that we are very good in all these five areas. We know. And you can also look upon the rating that customers are giving us in the NPS. We are quite strong in all these areas, without any doubt.

And besides that... Oh, I almost missed one thing. The values of the company. The values is not something that we just put on the wall. If you look upon what we offer, it's all about also how do you actually take this to the market? Integrity, making sure that you do the right things all the time. That brings, of course, how are we going to deliver this? Quality is of an essence, innovation is of an essence, and then, of course, collaboration. Collaboration is not only, you know, within the company and all the staff we have, it's also collaboration with clinics, listening to patients, patient organization. So collaboration goes way beyond the Vitrolife Group entity. It reaches out to the, to the users. So the core values is also ensuring that we are one step ahead of competition....

Digital, before I go into some of the different solutions we're offering, our value proposition is becoming increasingly digital as well. As you heard from Jørgen, iDAScore is an AI-based algorithm supporting evaluation and selection. We are looking into then, of course, facilitating for seamless data flows between different technology platforms and the EMR solutions of the clinics. As Dr. Rosen gave us a perfect example, this is a requirement. That will, in the end, become, you can say, as a product. So many more of the products we are actually going to be developing and providing will be in digital shape. It's not only the interfaces that is going to be more digital. Why do we want to make sure that we have a digital interaction with the clinics and all the stakeholders? Because they're fairly busy there.

Whenever they have they got the time to make an order, when they have the time to undergo education and training, we need to make sure that that resource is in place at the right moment, and that we do through these digital solutions. One of them is the Vitrolife and Igenomix Academy. So all the training we are conducting face-to-face, through webinars, et cetera. We also have them available online. Igenomix, in the Igenomix side of things, we got both a clinic portal, giving the information needed for the doctors to know all the ins and outs of our tests, being able to order, you know, a test from us, sending in a sample, and then, of course, getting back the reports, the outcomes of that test.

That's in the clinic portal, and we're looking at making sure that each and every clinic that is using us on Igenomix will be able to interact with us through the clinic portal. And similarly, we got a patient portal. So in that patient portal, again, they can learn about the test that has been decided they should be undergoing. In the U.S. case, it's actually the patient saying to the doctor, "I want to have this, I want to have that," and then we make the information regarding that test available in the patient portal. And then it's consent forms, it's payments, it's reports going to both the patient as well as the clinic.

Then the doctor is of course consulting with, "This is the outcome for you, and this is what it means, what we need to do next." Clinic portals, patient portals will become a natural way of interacting with the Vitrolife Group, and especially Igenomix, in that case. When it comes to Vitrolife and medical devices, we've got web shops, we have got EDI connections, we have punch-out solutions. In every way, we can be supporting seamless transactions. We will be making additional, of course, investments here because the world is becoming digital, and so are we, basically. And why are we doing this?

Because we need to make sure that the efficiency in which we're providing the information needed by doctors, embryologists, lab directors, and patients are there whenever they are—they want and have the time actually to be interacting with us, and that will improve customer satisfaction, that will improve the customer experience without any doubt. So that was a little bit shorter than what I think thought initially. With that, guys, I'd like to introduce again, then, it's Patrik Tolf, right? And we are going to be talking about operational excellence. And Patrik, you're the sponsor of that program, so can I please ask you to take over the stage for me?

Patrik Tolf
CFO, Vitrolife Group

Thank you. Operational excellence, and I would like to be joined by my colleagues here, leading then the business area. So first up on stage, we have Jørgen Östlund, leading Business Area Consumables, and then we have Claus in the middle, leading Business Area Technologies, and then we have Ricardo, who is leading our genetic services business. And we will talk you through what we mean with operational excellence. I mean, it's a relatively broad program, and we work and have been working on that one quite intensively over the past couple of years, and now we will take this one to the next step when it comes to operational excellence and driving that one. So it always starts then with the why. So if you look on the middle, yes, what is it that we want to achieve?

Yes, we want to achieve sustainable, profitable growth. That's something... Well, I've been working now within the company for two years, something that I'm really impressed on, what we have a skill, basically, you can say that's in the DNA-that is to drive sustainable, profitable growth. That is one reason why we focus on operational excellence. The other one, well, we've heard a lot of things about innovation during the course of the day here. We know that the clinics and the customers are really then eager to get those kind of solutions and integrations in place to increase automation, and that will also enable additional growth for the clinics, and then at the end of the day, obviously, also help the patients with a better clinical outcome. So that's also one of the driving forces here, that we want to fund innovation with operational excellence.

So how we will do that? Yes, it's about production efficiency and capacity, and we will hear a couple of examples on that. And at the end of the day, it's also about then the scaling operating model. That's the how. And then the what, yes, it's to continue to work on the process improvements, automation, continue to invest in latest technology. It's also about digitalization. We heard a couple of examples here from Rickard, but we have a lot of things to do on the backbone, in addition to that. All of those things are connected with the values. It's super important that all the mindset that we are working with when it comes to driving operational excellence is really tightly connected and with our values, and they are integrity, quality, innovation, and collaboration.

... I will leave the word over to Jørgen, who will start to explain more what you are doing within business and our consumables. You can go.

Janne Östlund
Acting Head of BA Consumables, Vitrolife Group

Yeah. 162 slides, and now it's my turn.

Mark Larman
Vice President of the Vitrolife Group Academy, Vitrolife Group

One slide.

Janne Östlund
Acting Head of BA Consumables, Vitrolife Group

One slide. Only one slide. No, I'm representing consumables, and that is the everyday usage of things that we provide the IVF clinics with. Mark Larman showed a picture just before about in the clinic with all the manual steps that they do. We have had very good success in the company. Rickard and his team has done a fantastic job selling our products, and we have come to a threshold where we need to automate our production even more. I'm happy to say that we have already started that. We started it a couple of years ago with our needle production. We have doubled the production there, and we have done it with good quality. Quality, like we talked about a lot of times here, is a cornerstone for us in Vitrolife. Quality is everything.

Without having any additional customer complaints, we have doubled production, and that is what we are trying to do, even moving forward. I see some familiar faces here. I've been showing our production in Gothenburg, and it's very good to see you here as well. You know that we are today both manual, semi-automatic, and also fully automated. Why do we have the mixture? Well, one thing is that we have not so big volumes, actually, so we can't use the economies of scale for everything. So we need to be very cautious when we do automation, and we need to do it with quality. I've been working for other med tech companies. I thought I knew what quality was, but when coming to Vitrolife, I had to relearn. Quality is on a totally different level in this company.

It is nothing that is just written on a paper, it's not on the walls, it's in the backbone of our colleagues. And of course, when having a lot of colleagues that have used IVF treatments to become parents, it's quite evident that it means the world for anyone who needs to go through that journey. So that's what we do. When we do automation, we look at quality, economy, and flexibility. And quality, as I said, is the cornerstone, and we have proven that many times that we can keep quality. Economics, some of you know...

There are two guys over there. I had the, the privilege to, to show our Gothenburg site a couple of months ago, and the first question when we come up to our quality control of pipettes is, "Why don't you automate?" Well, it's too costly, because it, it takes too much time, takes too much effort from, from a computerized system to do it. So then we use the humans when the humans are at the best. So that is something that we need to continue to do. And when moving forward to do the automation, we also need to not automate or do the automation in a way so that we block our future possibilities to change our products, because, as you've heard, there is a different position in U.S., Japan, and Europe.

So we will have different customer demands moving forward, and we, as a production site, need to be able to combine all those into unique products. By that, I'm handing over to Claus.

Claus Bisgaard
SVP Technologies, Vitrolife Group

Thank you, Jørgen. Is the mic on? Yeah. So, I want to extend the presentation from Jørgen just a little bit, because when Jørgen is automating the production, he's also looking at availability of the production equipment, meaning, is it reliable? And how often does it need to be taken out of operation for, for scheduled maintenance? Our customers are thinking the same thing when they buy an EmbryoScope to automate the embryology lab. So I'm gonna zoom in on the after-sales service operations for just a little bit, but we start back in the factory. So this beautiful instrument is produced in the factory in Aarhus, Denmark, and before it leaves the factory, it undergoes very comprehensive test and calibration.

Then it's shipped to the clinic, and in the clinic, it's installed by an instructor from Vitrolife, where we do the installation, and we do an installation qualification to double-check that it also works now that it's set up in the clinic. And then also the instructor do the user training, so we ensure that the users know how to use the instruments best way possible. And only then it's commissioned for clinical use. And now starts the after-sales journey. So from that day on and till the end of the lifetime, it's serviced by certified service engineers by Vitrolife, who is doing scheduled maintenance and obviously repairs, if that should be needed. Whenever these certified service engineers, they are in the clinic working with the instruments, that's hugely value-adding activities. So in terminology of operational excellence, we differentiate activities by value-adding and non-value-adding.

So in the clinic, highly value-adding, but when they're traveling to the clinic, that's actually not value-adding. And unfortunately, travel time and cost for the travel is a significant part of the cost of after-sales service. So we need to minimize the number of times we go to the clinic throughout the lifetime of an instrument to do service. We measure that by mean time between inspection or simply average number of days between visits in the clinic to service EmbryoScopes. So we're doing 3 things, 3 things to extend that interval. First one, we have systematically analyzed all subsystems and components in the EmbryoScope over the past years and implemented a number of improvements. These improvements have enabled us to extend the scheduled service interval from previously 6 months to now 12 months. Already there, we have a big benefit.

Second one is that we have implemented technology to do over-air software and firmware upgrades on the instruments, so we no longer have to go whenever we release an improvement, where we can typically do a lot on reliability with the software upgrade. So that's now done from remote, and we don't have to go for implementing these upgrades. The last one is a little bit more forward-looking, is that we will apply AI technology to real-time performance data of these EmbryoScopes, with the ambition to predict failures before they even have, you know, a real performance impact and before the user will even notice.

So with these three things, we, you know, today we are already at 160 days between visits on average worldwide, and with these three things, we are confident within a short period of time we will go above 200 days and even higher, a little bit longer term. Translating it to something that is easy to understand, already by next year, we will avoid 500 service visits in the clinics, and by 2027, it'll be above 1,000 visits that we avoid. So our installed base of EmbryoScopes is today 1,650, growing by the day. So that's a rather large population scattered all over the world. With this large installed base, we are now able to employ service engineers in local service hubs in many more markets.

So not only are we traveling to the clinics less frequent, we are also traveling shorter distances when we do have to go. So in summary, there are three winners of this. One is that for Vitrolife, we reduce cost of the after sales activities, so we can fund the innovation. Customers benefit from a very reliable system that, you know, enables them to keep the production going. And lastly, the environment benefit from significantly reduced greenhouse gas emissions. Over to you, Ricardo.

Ricardo Capella
SVP Genetic Services, Vitrolife Group

Thank you. Thank you, Claus. So genetic services. First of all, let me start by explaining a bit of our global footprint. So currently, we operate a total of 24 sites. These sites are organized by tiers. Tier one is the Valencia lab, which is our... You know, some of you, because I start to recognize faces, you have been to the Valencia lab. The rest of you are officially invited whenever you want to come. And in the Valencia lab, we basically, you know, it's the number one laboratories where we process the highest complexity test. And then it's supported also by a network of 5 tier two labs. Those are the highest volume labs that, together with the Valencia lab, you know, already can cope with the highest proportion of our samples.

Those tier two labs are in different parts of the world. Two of them are in the USA, one in the East Coast, in Miami, the other one in the West Coast, in Los Angeles. Then we have another one in São Paulo, then Dubai and Tokyo. The rest of our laboratories are smaller labs that basically run PGT-A for local customers and for kids and logistic sites that are not real laboratories. They're only, you know, supporting our commercial efforts in those areas. Now, this laboratory footprint, as we progress with our operational excellence project, will change over time, and you will see that in the years to come.

Now, as far as what are the key initiatives in our operational excellence inside genetic services, the first of all is that we are heavily investing in the latest technologies, focused on, of course, on the PGT space, given the importance, and Patrik will explain later also some numbers about that. Endometrium and lastly, in carrier screening, we are you know, anticipating demand. We are increasing our investment in that field. We are also working extensively in harmonizing lab processes to reduce complexity across the laboratory network. And we continue working on solutions to bring more automation to our operations so that we will you know, optimize protocols and overall, simplify workflows in the laboratories.

Now, the successful implementation of all these initiatives is going to bring a number of benefits to the organization. The first one is that operations will become a true enabler of the new product development. We have heard Carmen and the team talking about the pipeline of R&D projects, and those projects need to be supported by real operations that will make them become real products and not only concepts or research findings. Secondly, we will through the implementation of these initiatives, we will drive increased scalability and bring operational leverage to our organization, which eventually will let me support fully me and my team, the delivery of the overall financial objectives for the group, making our cost per sample come down.

Looking back and looking forward, what I can tell you is that we have a very strong track record of delivering operational excellence in genetic services. This is very much- it was very much in the DNA of the legacy, the former genomics company, and continues to be very much so, even more now inside the Vitrolife Group. So, you know, this is here, you know, to support the business for the years to come. And we are very much focused on that. Thank you.

Patrik Tolf
CFO, Vitrolife Group

So, I think we conclude there. We have now heard three tangible examples on what operational excellence is. So, I think we give Jørgen and Ricardo and Claus an applause. Thank you.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Okay. So we have now presented our five strategic pillars. There is one other very important thing that we would like to talk to you about today, and that is sustainability at the Vitrolife Group. And we believe that this is something that we have to have to the forefront of our minds, but also of our actions. I think never a time more appropriate to talk about sustainability in the week when we're starting to see reports come out of the COP meeting in Dubai. So with that, I would like to call up to the stage our wonderful head of sustainability at the Vitrolife Group, Sabrina Ritossa Fernandez.

Sabrina Ritossa Fernandez
Head of Sustainability, Vitrolife Group

Thank you, Bronwyn. Thank you, and good afternoon, everyone. My name is Sabrina, and in the next 15 minutes, I will walk you through what do we mean exactly when we say ensuring sustainability in everything we do, and how we are making that happen through the four pillars of our sustainability strategy. But before, it's important to see the context in which our sustainability strategy has been built, and it all starts with why and with our mission. Because our mission gives us the opportunity to address a really, really important opportunity in the market, which is to improve successful treatment outcomes and to help our partners improve accessibility as well. But this is not only a market opportunity, it's an incredible opportunity to make a difference in the lives of literally millions of people. As Bronwyn said, one in six people globally is affected by infertility.

And I was also struck by the number that Dr. Rosen gave, that is, the needs in the U.S. market are 10 times greater than what we can actually fill today. So imagine the difference we can make through all the initiatives and the projects and the innovation that we're bringing. And this is where our sustainability journey starts. It starts with our mission, starts by bringing positive solutions to our patients and customers. And how do we do this? This is enabled, of course, by innovation and quality, two of our key core values. But following our purpose is not enough. We need to be mindful of what we are doing. We need to do the right thing, both when it comes to ethics and when it comes to the planet.

As Bronwyn said, we are living really difficult times when we are thinking of climate change and what is ahead for us, but also for the future generations of people we are literally helping to put into this planet. And so here, as I said, no compromise on integrity, doing the right thing. Ultimately, we can only achieve all of this nice thing if we're collaborating internally, first of all, but also externally. We heard how this is important for our customers and to truly bring innovation out there. So you've understood it now. I'm going to go through each pillar of our sustainability strategy, but you see how the values are really the how here, of how we're going to really ground this, and how we're going to be confident that we're able to deliver on this mission and on these strategic ambitions.

Moving on to our first strategic ambition, purpose-driven growth. The ambition to keep growing, keep doing more of what we have already been doing really successfully for the past 30 years, following our mission, our purpose, our vision. We want to do that by innovating, by bridging the gap in successful treatment outcomes in accessibility, and keep delivering excellent quality and customer service. So we've seen this throughout the presentation. This is what we do. This. You don't need a sustainability person to tell you this, right? We've seen it in the presentations from Jørgen on how we're helping clinics to improve scalability, and thus improve access and reach all those patients who need it.

We've seen from Carmen how we are developing non-invasive genetic testing, and as a woman, I can really relate to that, on how it could make a difference on the patient journey. We've also got overwhelmed by the energy of Ricardo in the need and the will that we have to serve our patients in the best of ways. So I could as well put here our financial targets, because our success, of course, depends on this. But please, bear with me 11 more minutes, and then you'll have your financial targets. But before that, who better than our customers to judge us on how well we're doing on this? So this is why we have decided that here, the key KPI to measure how we are advancing on this is a Net Promoter Score.

Of course, the idea here, without fixating too much on the number itself, the idea is that we keep excelling and surpassing ourselves throughout the years. We're never going to be satisfied. We're always going to move forward and upward on this one… And as I said, forward and upward, but with safeguards, with mindfulness of what we are doing. We need to consider, of course, very important principles when we're doing business at our scale. And so we need to do the right thing, never compromise on integrity. And to do so, the first step, of course, is thinking: What are these principles that you wanna live by? And that we wanna make sure that everyone that works with us respect.

This is this has been captured in what we call at Vitrolife, the Principles for Responsible Business Conduct, which is our guide when it comes to ethical and responsible business conduct, that we have strengthened this year with updated commitments, for instance, on human rights or planet accountability. This is one of our first objectives, which is to make sure that everyone that works with us is also committed on these objectives and is also committed to these principles. Some highlights on the journey we're taking here. We've already rolled out this with more than 80% of our critical suppliers. Whenever we evaluate an M&A target, we also make sure that the target is potentially aligned with these principles.

This is very important, but we also, as much as we have now principles set in stone, that we wanna make sure we ensure all the time, there could be also unforeseen situations where we need to make a call, where we need to take a positioning, where we need to understand more and better. And so, even though we've have done this throughout the years, and we always had really brilliant minds available to us to think forward and to think proactively about the next challenges in ethics and reproductive health, we have decided to strengthen our approach, and we have now created a bioethics committee, a Bioethics Advisory Committee, that will really proactively guide us on, on the challenges that we face, being in the reproductive health industry.

Because this industry, it's an industry that has a lot of influence, and it's influenced by social, cultural, ethical norms, and we need to be at the forefront of that as well if you wanna be successful in innovating meaningfully and with purpose. And so you will receive more details on this committee in the coming days, but I can already say that we have three amazing external experts that cumulatively have more than 100 years of experience in the reproductive field. And stay tuned for more information on this as it will come up. Next, as we mentioned, interesting times we live in, the planet had also to be part of our strategy because of the company we are and what we're doing. And so here, the ambition is really simple, right?

What we need to do is to make sure that we contribute to keeping emission at the level at the 1.5 degrees level, as much as it seems further and further possible, but we need to do our part. So while we have started already efforts towards reducing our emissions within the products, for instance, in packaging, within our order patterns or within our operational efficiency measures, as you've seen it with the team presentation before me, we felt the need to strengthen our commitment and to work to have our commitment externally validated as well, because this is a really, really tricky field, and it needs some rigor as well as everything we do. So we have committed under Bronwyn's leadership to set near-term targets under the SBTi.

I think most of you probably know what I'm talking about here, as I also heard this was something that was important to some of you, and which is really great. And so this means that within the next year, now that we have a solid baseline as a group, and we have two years baseline where we have been measuring our emissions as a combined group, we will now go on and study and see what are the targets that we need to set and what is the strategy behind. So stay tuned here as well. And last but not least, us, the team, the one team, the Vitrolife team, of course, they had to be part of our sustainability strategy, and with two focuses, especially. First of all, engagement. Of course, engagement, wellness, well-being, listening to our people.

We conduct a pulse survey every quarter to check the temperature of the organization, and so this is one overarching target that we have, on keep beating the benchmark. Even though this year we are slightly close to the benchmark, but I'm confident that we're gonna be ahead very soon. And two, something that is quite specific to us, diversity and inclusion. Of course, this sounds almost like a buzzword these days, but for us, truly isn't. I come from the finance industry, so I know what I'm talking about. We are a diverse company here at Vitrolife. We have, as you've seen, we have scientists, we have, engineers, business people working together, 40 nationalities in a 1,100 people company.

We are fairly balanced when it comes to gender, so we truly have diversity, and this is truly an asset when you wanna innovate and look forward. But it's only an asset as long as it's combined with inclusion, as long as people are collaborating, working together, we're not creating tribes within the company. And so this is why it's important for us to look at diversity in all of its forms, you know, age, nationality, gender, together with inclusion. And this is what we mean when we say one of our overarching target is the Diversity Inclusion Index. And so we calculate quantitatively diversity metrics, and then we look qualitatively how our people feel when it comes to inclusion, so that everyone comes on this really beautiful journey with us.

I hope you'll join us in the journey, too, if you're not already, if you didn't already join it. The time has come for the financial targets, so I call my colleague, Patrik, to the stage.

Patrik Tolf
CFO, Vitrolife Group

Thank you, Sabrina. Let's move into the next section, which is the financial overview. I will talk you through some of the historical perspectives and also lead the way to, as you may have noticed already, that we have updated our long-term financial targets, and our thinking around that one. Starting with the historical, if you look on the growth that we have been doing, and here you see also the pro forma from 2021 to 2022. You also need to read the fine words below here, which is basically to get the math done. What we do here also for us to be able to compare and look on the performance is that we basically exclude the discontinued business that are basically no longer part of us.

That is two things, primarily, and that is then the COVID testing, and then it's then the divested GPDx business. The other thing that we also, when we talk about performance and how we drive that one, we always talk about local currency growth. Think about the currency exposure we have. We are selling about 99% of all our products outside Sweden, Sweden, and our reporting currency is SEK. In essence, we are short in two currencies, and that is the Swedish krona, and that's also the Danish krone, and then we are long in everything else. So that's why you see those kind of differences when it comes to currency exposure... sorry, when it comes to growth in SEK versus growth in local currency. So our performance steering internally and what we focus on, is growth in local currencies.

So 10% pro forma 2022 versus 2021, and then you see 21% in SEK for then. So that again illustrates the difference I just mentioned. If you look then on the gross margin, yes, we have continued to improve the gross margin over the year, and then been improving also on the EBITDA margin. If you then look on the year to date, again, coming year to date is then the third quarter for 2023. We also see that we have then had a growth of 5% in local currencies, 11% in SEK, and then continue then to improve the margins and then also strengthen not just the gross margin, but also then the EBITDA margin for the quarter. Now we are pretty late into the fourth quarter here.

We always state that the fourth quarter is normally the strongest quarter of the year, and given where we are today, we don't see any reason why that statement is still valid. So the fourth quarter is normally the fourth quarter. Yeah, that's right, but it's normally the strongest, and that's what we think it should be even for this year. Moving on then to... And this is then, of course, the consolidated numbers, and then I will talk you through when we have the geographical split. We have then those 10% and 5%, divided then by the different regions.

Starting then from the left, we saw that we grew 8% for the quarter, for the full year 2022 versus 2021 in Americas, and then we had a decline of 3% then on the third quarter, year to date. The main driver behind that one, we have talked about that one. I think you're all familiar with that one. That is primarily driven by the decline in ERA that we have been having, particularly in the US. EMEA continued to improve strongly, so over 2022 versus 2021, it was a +3%, and then during this year, we have strengthened the growth in EMEA with 6%. APAC has been fantastic over the past two years.

2022 was a really strong year, driven then by growth in both consumables and technologies, and so has it been for 2023, and all in all, then 5%. The other thing that we focus and steer on internally is the market contribution. So there, in essence, we take the sales and then divide, well, take out the gross income, take out the selling expenses, and that basically is then the market contribution. And out of that one, you get a contribution margin. And as you can see, I mean, you have the last year's number for the year to date in brackets. So we have then a decline, as you could expect, in Americas, from 31%-26%, increase in APAC and increase in EMEA. Moving on then to the business areas.

Again, here we see 2021 to 2022, and starting then with Consumables, and also again, just for us all to get a bit of a feeling on the structure within Consumables and the magnitude of the products. We have talked a lot about our media products, and the media products are representing the biggest part of the Consumables business, something like 60%, approximately. And then we have the disposable device part of Consumables business, something like 20%, and then also the Kisted business with some 20%. So that's roughly the magnitude of the distribution when it comes to Consumables portfolio. The same exercise for business area Technologies, that is the EmbryoScope, which is the largest seller within Technologies, as you all know.

The service component is increasing and has continued to do so. So the mix then between the service and the hardware sale is something like 70% approximately when it comes to the hardware sale, and then consequently, something like 20%-30% then when it comes to software and ongoing sales. If we then look on the genetic services business, who then grew 7%, 2022 versus 2021, the distribution of products within genetic services is that the largest part of genetic services are the PGT-A, which is approximately 50% of the portfolio. Then we have PGT-M. That comes on top of that one. And then also the ERA, which is about 20% of the portfolio, and then you have the residual 20%, which then consists of the other products that you see on the marketplace.

Carrier screening, as an example, ranging then to EMMA, ALICE, and POC, and IP, and so forth. So that's approximately then the distribution. If we then think about the impact at ERA, again, just for you to get a bit of a feeling for it here. We saw that for genetic services, we had a -1% growth during the year-to-date three quarters. If we then would have taken out ERA, if you would have done that, then that number would be 6% instead. Same month then for 2022 versus 2021, then the growth would be, oops, 11%. So yes, it has had an impact, or relatively large impact then on the performance of the genetic services, particularly, but then consequently then for the group. So moving on then.

Yes, going on then to operating cash flow. And as you see, and as you know, we have been able to deliver strong operating cash flow. We are now on a relatively close level to where we were at 2022 for just the 3 quarters. So, that ability then to deliver strong operating cash flow, of course, then strengthens one of our targets, which is then the net debt to EBITDA. Just after the acquisition, we were just north of 3x. Now we are getting down to 1x, where we currently are at the moment as well. So we will continue to get down on that one. This of course means that we have an opportunity. We are then well-capitalized to continue then to do additional acquisitions.

And as Bronwyn talked about previously, I mean, we are looking on various kind of opportunities, again, to strengthen our portfolio, strengthen our capacity, strengthen our capability to be able to deliver strong when it comes to building up on the platform and then continue to develop the company. So we are in a good position here. Continue then to drive net debt to EBITDA. So we have also then heard, and you heard Jørgen, you heard Ricardo, you heard Claus talking about what kind of activities that we are doing on the operational excellence. We are also then investing. We have been over the past couple of years. Here you see the CapEx levels. We have been then invested into manufacturing capacity, doubling our capacity when it comes to needles, as one example.

We have been focusing and working more on the automation in the lab processes, call it version 1.0, and we have increased our spending on R&D. Going forward, yes, as we heard before, we will continue then to ramp up both Genetic Services and Consumables capability. We will then focus on more, and we have heard several examples on that side, and what we will do when it comes to product development, innovation. We will focus on that one going forward. When we think about CapEx and the investments primarily that we will do then within business area Consumables, then it will be more on the hardware side. And then, of course, it will be a bit on the hardware side when it comes to Genetic Services. And then CapEx will also then be the capitalized part of R&D going forward here as well.

So we foresee that over the coming years, we will more or less double the capital expenditure. So, from there then to our updated, sustainable long-term financial objectives. And when I say sustainable, that means that all the things that Sabrina just talked about, I mean, it's not just sustainability, but it also is about sustainable, long-term financial objectives. So those are, of course, embedded into everything that we are doing. We have changed the growth objective. We come out then from a 20% CAGR over three years. That included then both acquisitions and organic growth. As time goes on, we have become larger as a company.

We wanted, and, and of course, then the growth component on that one, always becomes a bit more, well, larger, which means that in essence, we want to make it a bit more clarified and maybe not so relevant just to grow when it comes to have that as a target. M&As, we will be focusing on when it comes to other, areas and not relevant than to have that one as a growth target. So that's why we focus on organic growth in local currency on an annual basis, which should be more than 10%. EBITDA margin, we are increasing that one. We come out of 30%. We come out of 30% today and increasing that one to 30%-- 33%.

The net debt to EBITDA, we continue to keep that one as 3x, and the dividend policy is also then assumed to be 30% on net profit. Also, when we think about long term, yes, long term is about 5 years, and that is also then reflecting the new corporate strategy that we are working with. So hopefully we will bring some clarity, and particularly then when it comes to the growth target, because then we keep it more focused than on the organic revenue growth per year. Okay, so how do we then continue to drive long-term shareholder value? First of all, we have heard a lot of things today about what kind of underlying global market growth we have.

We know that IVF cycles will continue to grow between 5%-7% in the coming years. Of course, there are short-term challenges. We are addressing them. We have all heard about the ERA, and I think you hopefully, given with everything that you have heard today, are comfortable that we are taking a lot of actions, when it comes to the ERA testing. That is a short-term challenge for us. We have also seen, and we know that it's going to be a continuous trend when it comes to in-housing and, customer consolidation. To some extent, that's a good opportunity for us to take that one, and of course, there will be challenges connected to that trend as well.

But that will come, and we are knowing this one, and that's also why we make a couple of actions when it comes to focusing on R&D investments, to make sure that we are attractive, focus on digitalization, focus on investments in platforms and so forth, really to become a good and attractive partner to the clinics. So continue then to invest into sustainable, profitable growth and scalability. Examples that we've heard from our colleagues then leading the business areas. Focus on innovation, doubling R&D investments over the coming years. Again, if you look upon it from... When I say double, we mean double when it comes to amount, not so that if we will double the percent. You don't steer R&D as a percent of revenue. That is an outcome, not a steering.

So if you think about it then as a percent, then we are today somewhere between 3.5%-4%, and going forward, it might be a bit higher, maybe up to 5%. But that is, of course, depending on the growth of the company. But in number-wise, we are expecting that to grow going forward. We will continue to strengthen our presence and position in U.S., scaling up our manufacturing capacity, continue to invest when it comes to digital solutions, both backwards and forwards, and we will then fund a lot of these activities by being efficient and drive efficiencies through our operational excellence programs. With those words, Bronwyn, I leave it over to you to summarize.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Thank you. Thank you, Patrik. Excellent. Okay, you'll be very relieved to know that this is the final slide of the day before we open up for questions and answers. But essentially, what I would like to do in the next five minutes is to really synthesize and bring together everything that you've heard throughout the course of the day, to really ensure that you understand and that you believe and that you have confidence in the long-term corporate strategy of the Vitrolife Group. So just to pull everything together, we are operating in a market with five mega trends: a growth in demand, a demand that is expected to steadily increase over the coming years as access and affordability improves, okay? So currently operating in a market with growth between 5-6%, but expected to steadily increase over the course of this strategic plan.

Secondly, we spoke a lot about the labor shortages, the staff shortages, and the need to bring automation, scalability, standardization, digitalization to solve for some of these mega trends. Consolidation, it continues to happen. We spoke about this a lot in the context of the U.S., but this is a global phenomenon. Regionalization of the standard of care and how the Vitrolife Group is uniquely positioned because of our portfolio to capitalize on that opportunity and to be able to serve the different standards of care, but equally in terms of our next generation platform, to be able to bring the genetic assessment and time-lapse embryo evaluation together. And then, of course, the patient empowerment piece that we've spoken about throughout the day in terms of patients becoming more aware, better educated, and really seeking to have much greater input in terms of their pathway.

So these are the mega trends. What is our vision? What is the vision of the Vitrolife Group? We want to be the company that enables people around the world to fulfill their dream of having a healthy baby. And our mission, very, very importantly, when we get out of bed every single day and come to work, our whole raison d'être is to be the global leading partner in reproductive health. And through the combination of everything that we have presented today, we want to strive for better outcomes for patients as they embark on their IVF journey. Our values really, really importantly, and I hope having spent most of the day with the Vitrolife Group, that you're really getting a sense of we do believe in these values, we will live these values, and they will become core to everything that we do at the Vitrolife Group.

So our values, integrity, we will never, ever compromise and always do the right thing by the patients that we are here to serve. Number two, quality. I thought Jørgen did a superb job in terms of really giving you a sense of what quality means in the Vitrolife Group. And I can tell you, the minute I walked through the doors and the corridors of our site in Gothenburg, I could feel it, I could hear it, I could see it. Quality is absolutely synonymous with the Vitrolife Group, and we will absolutely preserve that going forward. Our third value, innovation. We have been pioneers in the field of IVF, and we want to continue to do so.

Yes, we are increasing our investment in R&D, but we are unapologetic about that because we believe that we have the capacity to bring new products, tests, services, and solutions to this market that will make meaningfully positive impacts for patients and also help us to drive double-digit profitable growth in the long term. And then our five strategic pillars. You're probably tired listening to me talking about them, but we are fundamentally believing that these pillars will be absolutely paramount to ensuring our future success as a company. So just for those who zoned in or zoned out, the five strategic pillars, maybe I should have set this as a, as a little quiz for the end. So own the platform, connecting products and services. Number two, anybody want to have a guess? Expand innovation. Absolutely.

We want to continue to be the innovators in the IVF space and expand our leadership position there. Number three, I thought Rickard did an outstanding job, and his passion really came across in terms of how we want to accelerate our growth in key markets. There are lots of areas where we can grow. We called out the U.S., China, but also key markets around the world, where we already have really, really strong momentum. Our fourth strategic pillar... We're almost there, folks. Our fourth strategic pillar is to optimize our go-to-market model. And then finally, supporting all of these initiatives is our program to drive operational excellence at the Vitrolife Group, to ensure that we can fund this journey and continue to grow our company profitably. And then, Sabrina, thank you. I thought you did a wonderful job on sustainability.

We are serious in terms of the Vitrolife Group as a company; we are serious in terms of our commitment to sustainability. And I have to say, as a mom of a 14-year-old and a 10-year-old, it is absolutely to the forefront of my mind that we need to do a better job and leave a better planet than the one we are currently living in. And certainly, I don't want my legacy to be part of something that hasn't left a better place for my children and hopefully my grandchildren, if I get to see them someday. So to tie it all together, this is the new corporate strategy of the Vitrolife Group, and we believe through the execution of these 5 strategic pillars, we will return our company to double-digit profitable growth over the coming years, and we will grow profitably above the market growth rates.

With that, I would like to sincerely thank you. You've been an incredibly attentive audience. We're now going to move to questions and answers, and I'd really, really encourage you to ask lots of questions. We'd love to hear your feedback, your thoughts, and your comments. So with that, thank you very, very much. We'll move to Q&A. Tack så mycket, muchísimas gracias, and to everybody who's listening online, I believe we have over 100 people, thank you all so much for your attention, too. Thank you. And with that, I'll invite all speakers up on stage for our questions and answers. Thank you.

Patrik Tolf
CFO, Vitrolife Group

Can we be sitting over there as well?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah.

Patrik Tolf
CFO, Vitrolife Group

So there will be, microphones running around in the room here with a bit of a help. So who wants to start?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Suzana.

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

Thank you, everyone, for the really detailed presentation today. My name is Suzana Queckbörner, I'm from Handelsbanken, and I'd like to start with a question to Patrik. So in terms of your 33% or larger than 33% EBITDA margin target, should we expect that something to be achieved by or within the next five years, or should we already expect that to continue where we are now for 2024?

Patrik Tolf
CFO, Vitrolife Group

I mean, we are at a good starting point, so we will continue to make investments, as we have talked about, throughout the course of this day. We will continue to invest; we will continue then to increase when it comes to sales and marketing in U.S. We will be able to fund that through our operational excellence. So we will be at a level where we are today, approximately on the coming years as well.

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

... Okay, thank you. And then, a follow-up question for, Dr. Mitchell Rosen. When you were talking about the efficiencies, achieved with, the time-lapse technology in your clinic specifically, and I appreciate that your clinic isn't necessarily representative of most clinics in the U.S. in terms of capacity. You said it's time-saving, but in terms of how many added cycles did you achieve?

Mitchell Rosen
Professor and Lab Director, UCSF

Oh, yeah, we achieved that. So if you recall, it's a good question. In 2017, we were roughly one-third less. So, it was with the same amount of, let's call it embryology staff, we were able to achieve an increase in one-third. Now, I needed some administrative staff to do so, but the same embryology staff, it, so it was quite a bit of savings. Yeah. So what we calculated was absolutely correct.

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

Okay, and that would be thanks to time-lapse, or also, would you say general structural changes?

Mitchell Rosen
Professor and Lab Director, UCSF

Mostly the time-lapse. Yeah.

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

Thank you.

Mitchell Rosen
Professor and Lab Director, UCSF

Yeah.

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

If I could, can I have a third question, and this one to Dr. Gardner. In terms of the Australian perspective, and as far as I understand, this is one of the most established markets, but you also have very high reimbursement compared to other markets. How would you say that regulation has impacted reimbursement of these auxiliary services that are added, or how are you thinking about that as, as-

David Gardner
Scientific Director, Melbourne IVF

Can you define auxiliary services? What do you mean by that?

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

I would say additional genetic services or any kind of additional coverage. What is base versus what is an add-on?

David Gardner
Scientific Director, Melbourne IVF

Right. So the basic cycle covers pretty much all aspects of IVF, but genetics screening will be an add-on. But all other things are included in the cycle. So there's no laboratory add-ons, for example, there's no addition for time-lapse or special transfers or whatever you can consider an add-on. They're all brought into the fundamental package of what is IVF.

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

Thank you.

David Gardner
Scientific Director, Melbourne IVF

Yep.

Ole Trætner
Analyst, Carnegie Investment Bank

Now we have over there. Thank you very much. Ole Traetner from Carnegie here. Three questions on my end as well, and perhaps I'll start off with you, Patrik, and the financial targets that you've set. And also sort of going back to previously communicated margin ambitions for genetic services to track above 30%. Is that something that you still stand by? And in addition, saw a few actions that you're currently undertaking to improve margins, but how about just increasing utilization of these labs? Because-

Patrik Tolf
CFO, Vitrolife Group

Hmm

Ole Trætner
Analyst, Carnegie Investment Bank

... that is the key aspect of driving margins for a genetic lab.

Patrik Tolf
CFO, Vitrolife Group

No, thank you for that question, and what we have been doing then within genetic services, so you heard a couple of examples on that one, Ricardo saying that we have a strong track record when it comes to driving operational excellence. As one side of the margin improvement for genetic services has really then been to improve the cost efficiency, and that we've been able to do. I mean, despite then basically having a drop when it comes to the revenues for this year, we have been able to actually increase the margin. So that, again, shows that we are able to do this one in an efficient way.

So we do not really then follow, and steer, and guide you externally then on the, on the EBITDA margin per the business areas, but it is going in the right direction, that is for sure.

Ole Trætner
Analyst, Carnegie Investment Bank

Okay, great. And second question would then be to address to Professor Simón and potentially even a wider scope of... Just on a non-invasive side, obviously it's something that is very important, there are some differences between EMEA and US, EMEA regulatory and the US more on the workflow. But just how important is it to run this non-invasively? And on the PGT side, and potentially for all of these, how do you work around the maternal cell contamination risk? And in addition to that, just a question on the importance here to create more data generation or clinical evidence to support the ERA, ALICE, and EMMA, in order for that to gain acceptance, your current view on that.

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Thank you. These are key questions, so I think that, that these are, very good ones. So let me start by the last one. When you create, something new, there is always two thing that happens. First, this is the fight between visionaries and guardians of the faith that provoke these scientific innovation phases that you saw. So this is always what is happening. And the second thing is, you get copy. If, what you, what you did is, is, is fine, it works, you get copy, and you get, immediately many companies doing this. This is what is happening with, with the ERA test and with, with the other test, EMMA and ALICE, that we have done. There are already 10 different, copy-paste of this, and...

Altogether, the thing is, the way forward is that at the end, every test will find its own indication. But now, this indication comes with 10 different competitors that they are competing. This is called Ermap or something, and some of them, they just keep even the same name, and they just copy and paste the same market thing. So, this is how this is going to move forward, and next step for that is non-invasiveness, and the next step is to create a new product that will be able to move forward to the next step.

And that's why it's so important to have a good research pipeline that will put you something in three years when the market is crowded, and the only solution is to lower prices until you go to zero, which is what's happening with the PGT-A now, that the competition is to lower the prices. So these are the two different steps that will follow from that, and this is happening now with PGT-A. The non-invasiveness of PGT-A is something logical that happens because in medicine, nobody goes to the surgery room opening your body to do any intervention. You go through endoscopies, and with endoscopies, you are able to remove or fix everything. So non-invasiveness, if we consider the embryo as a patient, is the logical way to move forward.

But there is a big burden there, which is that now embryo biopsy has created their own ecosystem around, which means you have to have this microscope, people trained from that. And the clinics, they are charging for the biopsy, something like 20 times more than for the test itself. So if the embryo cost to be analyzed $100, the sub-clinics will charge $5,000, $4,000, and... So this is, interestingly, when we plan thinking the patient and the embryo, the way forward, we did not plan this resistance that come because of that. But this is out of our scope now because this is how we are facing.

However, I'm sure, and we were sure when we planned this with Carmen seven years ago, and I'm sure that this is going to be the future. Because when the patient sees that the same analysis can be done without punching the embryo, taking a few cells, and also these cells, they are just a sample of the 100 ball of cells, and this create issues like, maybe you have heard about that, mosaicism or different situations, this is going to happen. So, we are ready for that. The maternal contamination is something that we have from the very beginning consider. We may add SNPs, we may add... I mean, technical solutions, we have it. Nowadays, concordance is more than 90%. 90% concordance, which doesn't mean that the invasive PGT-A is perfect.

On the contrary, we have seen, and this is a paper coming now, that when we have full concordance between invasive and non-invasive PGT-A, and we compare with what happens when we have discordance, then miscarriage increases. So if PGT-A invasive say, "This is normal," and we confirm that, and but if we say, "No, this is not normal," then miscarriage is higher. So what I mean is that, I'm making a very long,

Mitchell Rosen
Professor and Lab Director, UCSF

Mm-hmm.

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

a very long, I'm sorry about that. But, as you have seen, we have been working with that-

Mitchell Rosen
Professor and Lab Director, UCSF

Uh

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

-for a long time. So maternal contamination is a technical issue that is solved nowadays and will be solved by adding SNPS or adding other technical issues, and non-invasiveness is the next step. But then the last step is to create the new product that will be able to improve what we are having now, and I think this should be the work, and I'm sure that Bronwyn is on that, and she understands perfectly that a good research pipeline will make a difference.

Mitchell Rosen
Professor and Lab Director, UCSF

Can I add one thing to that, too? If you can remove the technical challenges or the expertise that's required also to micromanipulate the embryo, 'cause doing an invasive biopsy takes expertise, and you can get the fluid and do the test, that would create a significant improvement in efficiencies and not require that technical expertise. So the idea of having non-invasive, if indeed we can get there, is definitely the next forefront.

Ole Trætner
Analyst, Carnegie Investment Bank

If I'm not mistaken, you actually removed some regulatory hurdles in certain markets in Europe by doing it only invasive, right?

Mitchell Rosen
Professor and Lab Director, UCSF

Hmm, right. That one I don't know about in Europe.

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Yeah. Well, some countries, even, like Germany, because the embryo protection law, even if you do this non-invasively, still you're analyzing the embryo, and this is an issue for them, but, you know, every country has their own regulations.

Ole Trætner
Analyst, Carnegie Investment Bank

Great. Last question on my end, and I would like to address Dr. Rosen. You're obviously an early adopter of time-lapse in the U.S., but could you give us some understandings why so few of your colleagues in the field in the U.S. are utilizing time-lapse? Obviously, it sounds like a compelling technology. Do you believe there needs to be more,

... evidence created combining time-lapse with genetic testing in order for your colleagues in the field to purchase and to time-lapse?

Mitchell Rosen
Professor and Lab Director, UCSF

I think it's a good question. I think it's probably... I think it's more about... It's a combined situation. I mean, in the U.S., it's all about really, I mean, the pocketbook to some degree, and this equipment is very, very expensive. I think in the beginning, it was all about the thought processes of improving pregnancy rates. And initially, it didn't really prove to be the point of it, just that in itself, improving the pregnancy rate. So the question was: what would be the return by using it, right? And so the idea of increasing efficiencies and then ultimately leading to the automation and further increasing efficiencies, and then ultimately leading to improvement in pregnancy rates, if we can combine all this stuff, I think it'll all be about education and what's key—what happens in the forefront.

I really think that's probably the case. I mean, it's a no-brainer that putting it inside a box that you don't move is gonna provide for a decrease in error and an overall safer environment. But it's gotta actually lead to a change in, in the pocketbook at the end of the day, and hopefully, pregnancy rate, of course. Speaking like a true American.

Ole Trætner
Analyst, Carnegie Investment Bank

Great. Thank you.

Speaker 20

Okay. You want to hear us on the Redeye . Start off with Patrik, I suppose, on organic growth or the 10% growth target for the five-year period. Near-term, you have some challenges, so ERA is the obvious one, perhaps also China anti-corruption measures could be an issue indirectly. Should we expect? Is it reasonable to expect a sort of slightly lower growth initially to pick up with the innovation and improvements during the period?

Patrik Tolf
CFO, Vitrolife Group

Do you want to take that one, Bronwyn?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yes, that is the short answer. I can give you a very long-winded answer or a very short one, Johan. So, we do face challenges in the near term. I think we've been very honest and transparent about that today. But we are still optimistic in terms of our ability to drive growth above the cycle growth. So despite those challenges, we do believe in our ability, even in the nearer term, to drive above market growth cycle-wise. But yes, absolutely, to return to double-digit territory, that's going to be a journey, and we will need to execute. This cannot be an academic plan. We have to execute on the strategy as we laid out today to ensure that we do that for the medium longer term and that we do it profitably.

There is growth to be had in this market. Not all growth is created equally. So I think that's got to be the key, right? Driving growth, but driving profitable growth.

Speaker 20

Yeah, substantial part of your business is already on target, of course. You're not guiding or providing a target on capital efficacy, but presumably, that's a concern as well. How should we think about that? It's a fairly low level so far.

Patrik Tolf
CFO, Vitrolife Group

No, I mean, we, we are guiding then on the, net debt to EBITDA, and to some extent, that really then, of course, says something about the balance sheet, but not the full thing about the balance sheet. So of course, we are working on capital efficiency, and to improve both, Well, both on the, on the, on the structure and then, of course, on the our side of it, as well. But we have not expressed any more specific financial targets when it comes to, those kind of metrics. So we keep the net debt to EBITDA. I think that's a pretty good, measure, that fits both when it comes to the, to the debt side and also when it comes to an overview on the capital allocation as well.

Speaker 20

Yes, and finally, well, Dr. Rosen, I suppose, again, it's interesting with the increased support from reimbursement, on, on your side of things, it's mainly the private insurance side. How does that affect the, the patient group and the patient interaction and, and the sort of questions or expectations they have?

Mitchell Rosen
Professor and Lab Director, UCSF

Okay, I'm gonna try to clarify the question, just to make sure I understand it. So what we're saying is, with the uptake of more insurance, how does the patients... I guess maybe I'll phrase it differently. The patient's experience change, or what are they requesting? Is that the question, kind of the question?

Speaker 20

Yeah, their expectations and the interaction with the patients, perhaps, if any.

Mitchell Rosen
Professor and Lab Director, UCSF

Let's see, what have I noticed? That's probably a really good question. I think they're a little bit more at ease. When it's coming out of their pocket, there's a lot of pressure. And I'm not just saying this on the physician side, I'm saying that on the patient side, because I hear all kinds of stories that they've refinanced their house, that, you know, they're doing everything in their power to basically just scrape by to get a cycle. And with insurance coverage, that does put things at ease, and I think that it does allow for, obviously, I mean, this is obviously more cycles to be done, right? 'Cause we're increasing access by doing so.

Speaker 20

... Yeah, and finally, related questions. It's really interesting with the China pilot and, what's reasonable to expect in terms of time, timelines in the result from that pilot?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

I can take that one.

Patrik Tolf
CFO, Vitrolife Group

Yeah.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

So thank you for the question, Johan. Yeah, so what we're seeing in China is essentially reimbursement slowly but steadily increasing on a province-by-province basis. The Beijing pilot that, that you mentioned, you know, started some time ago, very difficult to call it exactly, but from the feedback that we're getting from our team on the ground in the market, we would expect to have some positive news coming out of that in, in quarter one. So, you know, slowly but surely, reimbursement on a province-by-province basis in, in China is opening up. Now, that doesn't necessarily mean full coverage. It's usually partial, and with restrictions. China has, slightly different protocols to, to, other parts of the world, with a lot more fresh cycles. But in terms of the trajectory, you know, looking positive for, for quarter one next year.

Speaker 20

I can add another one for you. It's very powerful, of course, with your ambition and ability to digitalize, provide AI, digitalization, integration. But I guess it comes with the risk of increased price pressure, if you're handling high volumes very efficiently. Is that a concern?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

I can... Will I take that one?

Speaker 20

Yeah. Okay.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Okay.

Speaker 20

Yeah.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Sorry, I feel like I'm-

Speaker 20

Yeah

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

... speaking too much, but I'll maybe start, and then I can-

Speaker 20

Mm-hmm

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

... I can hand over to Patrik. We, up to now, haven't experienced significant price pressure. I expected coming into the Vitrolife Group, quite honestly, to, to see more. That does not mean that I'm naive or complacent and not expecting that it will come in some shape or form. I think, Johan, what we're trying to do, certainly it's our intent with our sort of platform play, is to get ourselves out of a, you know, sort of market share dogfight, product by product, and really look at the holistic value that the Vitrolife Group can bring with the entire platform, all of the products and, and services. It, it won't make us immune to price pressure, certainly not, but it should certainly help to insulate us in terms of the value that we bring to, to the core of the lab.

We do have differentiated products, tests, and services. Generally, in healthcare, when you have differentiated products, tests, and services that bring value, you know, doesn't completely protect you from price pressure, but certainly, certainly helps. I mean, most of the companies where I've worked over the past 26 years, I would say, are premium price-

Speaker 20

Mm

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

... more innovative companies. And, yeah, there are waves of price pressure, but generally, if you continue to innovate and can demonstrate, to Ulrik's point, with clinical evidence, that you are bringing improvement in outcomes, to the area in healthcare where you're, you know, playing, my experience is that healthcare pays a premium for innovation and improved outcomes. And back to the outcomes discussion, we're at 30%-35%, so we have a need for innovation, premium products, and quality.

Speaker 20

Yeah, and you have a lot of data as well.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yes.

Speaker 20

Thank you.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Very welcome.

Patrik Tolf
CFO, Vitrolife Group

Now, I think it was Jacob, right?

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Okay. Thank you. It's Jakob Lembke from SEB. So starting with the sort of growth target, I think, 10%, should we think about that sort of as an average for all of the business areas, or is this something you want to achieve in all business areas independently?

Patrik Tolf
CFO, Vitrolife Group

I mean, the target is expressed for the group. Yes. So, that is applicable for the group.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Can you maybe elaborate on which ones you expect to be higher and then maybe lower?

Patrik Tolf
CFO, Vitrolife Group

No, I mean, I mean, as you know, right, I mean, Consumables business continue to grow and, and, and has been then doing that one strongly in the past as well. Also, then quite, quite, tightly connected with the overall cycle growth. And as you know, Technologies that, with the component of capital sales on the, on the Technologies, that will be, over time, a bit more, call it volatile, depending on bit when we get orders or, or not get orders and make installations or not make installations. And then, of course, you have the Genetic Services, which currently, as we know, are a bit under pressure when it comes to the array.

But also here, we have an opportunity to continue then to leverage on the strength of the portfolio for us going forward.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Okay. And then on genetic services, today, sort of heavily tilted towards PGT-A and ERA and PGT-M. And perhaps for, for Carlos, sort of when you look maybe five or 10 years out, how do you think the sort of distribution of tests will look like?

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Yeah. Well, the embryo is going to be always... I hope that now it will extend. Keep in mind that the rates that I give you, 50% of penetration, this is USA. Europe is less than 10%, probably 6%.... So the embryo will grow because I foresee that every cycle, every IVF cycle should be done with an euploid embryo, which is quite logical. So this will be growing, and I hope that we will be able to surpass this barrier of penetrance of non-invasiveness, and this as Dr. Rosen mentioned, I do not see why it should not be done in any cycle that has been done. Then the endometrium will have different indications according to the type of test that we are doing.

For ERA, it will remain for the most difficult patients, which is great because this is a source that we have. The EMMA test, that we can do it now non-invasively, this can be done for every patient because at the end, we are preventing not only infections, but also the outcome in pregnancy. Many times, preterm birth, rupture of membranes are due to endometritis that are prior to pregnancy. So I think that, there will be some tests that will have a specific indication and some endometrial tests that will have a wide indications. But overall, it should come new tests that will surpass those one, and we have to be able to be cannibalized by something that we produce that is better. So I think that this will be basically how I foresee this in five years.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Okay, and then just lastly on the EmbryoScope. To me, it seems like a sort of no-brainer to adapt this. So my question then is, sort of what can you do to sort of improve the usage of the EmbryoScope? I mean, it's still quite a low level for what it brings to the clinics, I would say.

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Well, EmbryoScope, like the concept of lab in a box, is also coming because you have these 1 million expensive IVF laboratories that can be substituted by different modules in which the embryo will be placed and the oocytes will be obtained. Fertilization can be done automatically, and then the embryo can, the growth can be there, and at the end of this, with the proper embryo culture media that David Gardner has mastered this, and at the end of the day, you have a closed system that in one part you will have the embryo to transfer, the other part you will have the culture media where this embryo has been grown. You can do all these non-invasive tests on that.

You avoid any type of human intervention, human error, and but this is another different area, which I think that Vitrolife Group is very well situated to be able to move the automation and robotization to the IVF laboratory.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Okay, that's kind of long term, but maybe more for Bronwyn or Patrik. What can you do more in the short term?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah. So thank you for the question, Jacob. I think it's a combination. We have, clearly, we're making advances with our iDAScore, so that helps-

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Mm-hmm.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

-with embryo evaluation. We haven't focused as much, and please, Claus, correct me if I'm wrong, but I don't believe we've been focusing as much on workflow. And really, as we-

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Mm-hmm

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Started to look at the example of, of Dr. Rosen's, you know, the clinics where he's working, and we ran the math and really saw the extent of the value that time-lapse can bring, that really needs to form a stronger part of the value proposition of time-lapse EmbryoScope going forward. That, combined with the additional innovation that we need to bring, 'cause we have to stay ahead, okay? We have a fantastic technology, Trojan Horse, but we do need to stay ahead, Jacob. So I think focusing more on time-lapse holistically, as opposed to it's not just for aiding embryo evaluation and selection, but rather workflow, automation, the significant amount of time that the embryos spend in time-lapse, these all need to form part of our core messages going forward. So I hope that that answers your question.

Claus, please feel free to take a microphone if I'm not doing it justice. Okay.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Thank you.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

You're very welcome.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Thank you. Just in terms of the tipping point when time-lapse EmbryoScope penetration in the U.S.-

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Mm-hmm

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

-increases, is it approval of iDAScore? Is it your reference, Bronwyn, to Vitrolife investing in its positioning in the U.S. and having more of a direct conversation with the owners of the clinics? Because the embryologist is the decision maker, presumably on the time-lapse, but the size of the investment and the ROI thinking behind it surely-

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Mm

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

is more relevant to the owner.

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Mm-hmm.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

Often, the owners are not the embryologists. They may well be in some cases.

Carlos Simón
Professor of Obstetrics and Gynecology, University of Valencia, Igenomix

Mm.

Jakob Lembke
Equity Research Analyst, Healthcare, SEB

But if you could talk about what you mean by strengthening your position in the U.S. and where you're going to invest? Thank you.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah, excellent. And, Claus, maybe you might talk a little bit about time-lapse as a service and the flexibility that we're bringing into our financial models. So, thank you for the question. It's multifactorial, so we need to increase our presence in the U.S. in order to have more people to have those conversations with the CEOs of the large chains. Then we need to be able to bring in the clinical experts because, you know, doctors, embryologists want to have the technical conversations around the time-lapse piece. The financials are really important. I've worked in capital businesses in the past. It's a very, very different sell, and I think you need to be able to show with health economic data, economic data, the improvements that can be made. I mean, Dr.

Rosen has spoken about that, but you need to be able to do that on a consistent basis. Back to the value proposition, much more focus on the sort of broader impact of time-lapse, I think is important. iDAScore, you know, the reality is we don't have approval in the U.S., and that's a challenge. The only path to U.S. approval is a de novo submission to the FDA. It can be done, but it takes time, and it is obviously something that we are working at and looking at, in addition to what are the other, you know, KPIs and metrics that we can bring and bring to the workflow or bring to the assessments that really, really help the clinic. So in short, it's multifactorial.

We need to address it from several angles, which we are. You know, it's difficult as things get tougher on the macroeconomic front, it is difficult to get private customers, private chains, to make those capital outlays. So we have been looking at more flexible financial models in terms of time-lapse as a service. Maybe, Claus, you might want to just pitch in to explain some of the things that we're doing in that area as well.

Claus Bisgaard
SVP Technologies, Vitrolife Group

I can, yes, but once you've listened to Mitchell Rosen's story of the, the-

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah.

Claus Bisgaard
SVP Technologies, Vitrolife Group

-clinical efficiencies, in the clinic, I honestly think that the financing becomes relatively uninteresting-

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah

Claus Bisgaard
SVP Technologies, Vitrolife Group

... because, you know, the value is so high. Anyway, we have, over the past years, pioneered with time-lapse as a service, as an alternative way to finance the EmbryoScopes. We're also-

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah

Claus Bisgaard
SVP Technologies, Vitrolife Group

... offering, in some instances, some installment models where we do... You know, you pay over a little bit of a longer time, so you can bring in the instrument, prove it to yourself and to the owners, that it works, and you do get the benefit predicted, and then, and then move on and adopt it 100% as, as Mitch has done. Yeah, so the options are there. I do think that we, for a period of time, have spent too much time, probably from Vitrolife-

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Mm-hmm

Claus Bisgaard
SVP Technologies, Vitrolife Group

... to talk about time-lapse as a selection tool, mainly because that's, you know, where we-

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah

Claus Bisgaard
SVP Technologies, Vitrolife Group

... where we've come to in Europe. Whereas in U.S., I think for now, the focus should be more on the,

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Mm-hmm

Claus Bisgaard
SVP Technologies, Vitrolife Group

... on the workflow benefits, and then combining it over time-

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Mm-hmm

Claus Bisgaard
SVP Technologies, Vitrolife Group

... with better selection as well.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yep. Thank you.

Claus Bisgaard
SVP Technologies, Vitrolife Group

Good.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Thank you very much. We have some questions online, Jim? Okay. And we have—I think we still have a couple more hands up, actually. Yeah.

Patrik Tolf
CFO, Vitrolife Group

The question is on R&D: Can you provide more context on how we should think about the increased investment going forward?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Do you want to start, and I'll-

Patrik Tolf
CFO, Vitrolife Group

I can start.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Okay.

Patrik Tolf
CFO, Vitrolife Group

So I think what we will do when it comes to R&D is, again, we have talked on the various kind of areas that we want to continue continuously going forward, we want to focus on innovation. When we say that we will double the spending when it comes to R&D, yes, that is in numbers that we think that we will double the amount of money that we will spend on R&D going forward. Percentage-wise, yes, that will also then be a % of the revenues that will increase compared to where we are today.

We will also then bring a bit into this one when it comes to CapEx, and then some of it, depending a bit on what kind of context it is, it will of course be then capitalized on the balance sheet as well. But I think, the other thing that we are really fostering internally, that is connected then to the values when it comes to innovation. So we are now call it creating then a innovative, more driven culture when it comes to innovation. So that's also something that really is important topic for us to drive innovation internally as well.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah, and maybe if I could just say, you know, I spent quite a bit of time working on, on, on R&D and innovation and on accelerating the adoption of new technologies and therapies. When we say increase investment in R&D, it's not like we are, you know, writing black check-

Patrik Tolf
CFO, Vitrolife Group

Mm-hmm

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

... blank checks for blue sky investment.

Patrik Tolf
CFO, Vitrolife Group

Uh-huh.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

We have a very full, robust R&D pipeline. Why do we believe we should invest further in R&D? It's to accelerate that, the rate at which we bring those products to market. There's no point in having an attractive R&D pipeline if you can't bring those products, tests, and services to market in a reasonable timeframe, and we need to be able to accelerate the rate.

Patrik Tolf
CFO, Vitrolife Group

Mm-hmm

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

... at which we do that. The second point is, you can have the best innovation in the world, if you don't invest in the market access capabilities in order to bring those tests, exactly like we're talking about with iDAScore, you need clinical evidence, you need health economic data, you need to work on your regulatory dossiers. All of this takes time, and I think companies are learning, okay? Many companies are learning the hard way that your R&D pipeline, you know, is only as good as the market access capabilities that you have to complement your ability as a company to bring those products to market and accelerate their growth in those markets. Access is, is really, really important. So that's, that's another key, key part of, of our R&D and our investment strategy.

So don't sort of think about, you know, going big on R&D blue sky. No. A very good, robust, well-thought-through pipeline that we believe we can accelerate and bring to market faster, supplemented with market access capabilities. Sorry, I'm getting on my soapbox about R&D, but.

Patrik Tolf
CFO, Vitrolife Group

Mm

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

... I've seen companies do this really, really well. You know, I spent six years at Medtronic. I thought Medtronic, certainly we, back then, was really, really excellent, not just at innovating, but at helping to drive adoption of those innovations in the market. So I hope my passion for R&D is shining through.

Patrik Tolf
CFO, Vitrolife Group

And then we have another question here from the web, right? So how are you going to measure progress against your strategic pillars? What are the KPIs? You want to start.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

So-

Patrik Tolf
CFO, Vitrolife Group

Yes.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

I can start.

Patrik Tolf
CFO, Vitrolife Group

Mm-hmm.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Metrics and KPIs are very, very important. Okay, what we have presented today, we have to execute on this as a company. So each of those strategic pillars that we have presented has been assigned an owner, and each of those owners, okay, members of the executive management team of the Vitrolife Group, have broken down those strategic pillars into actionable bites that we need to be tracking month after month, quarter after quarter. So we are really bringing rigor and discipline into how we measure, track our progress towards those key milestones. I'm talking down to dashboard level, red, green-

Patrik Tolf
CFO, Vitrolife Group

Mm-hmm

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

... and orange level.

Patrik Tolf
CFO, Vitrolife Group

Mm-hmm.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

So, you know, maybe just to give a very concrete example, if we take accelerate growth in key markets, we are setting a more aggressive target for the U.S. You know, it's. We're bullish about the U.S. We, we need, you know, really need to be ramping up there. What does that mean? We've set targets in terms of the headcount we need to recruit by when, the capabilities that we're going to need, the clinical support. So each and every strategic pillar has been broken down with process owners assigned and key metrics. And we will be tracking that and also presenting it to our board. We're going to be very, very transparent in terms of how we are progressing towards achievement of those strategic pillars.

Patrik Tolf
CFO, Vitrolife Group

Mm-hmm.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

I don't know if you have anything else to add to that one?

Patrik Tolf
CFO, Vitrolife Group

I think that was an excellent answer.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Okay, thank you.

Patrik Tolf
CFO, Vitrolife Group

Moving then to back to the room. Additional questions from anyone in the room here?

Ole Trætner
Analyst, Carnegie Investment Bank

This kind of connects to your previous statement, since it's a lot of talk on the U.S., and this might be a strategic one addressed for you, Bronwyn.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah.

Ole Trætner
Analyst, Carnegie Investment Bank

Your, your main competitor, they're larger than you in the U.S., and one of their key success factors in the last few years has been a product that you don't have in your portfolio, the RI Witness. How much of a hampering factor is that for you in order to gain access to the U.S. IVF clinics? And is that something that you would be strategically interested in exploiting on your own, given sort of success rates in the U.S. that we have seen by those who actually have the solution?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yeah. So thank you for the question. Great question. There are several witnessing systems out in the market. One of our main competitors in the U.S. clearly has a witnessing system, and there are pros and cons to all of them, okay? You know, connectivity, you start to get into the ecosystem of EMRs, and it can get very, very complicated. You know, companies have witnessing, we have time-lapse, which is where the embryos spend the bulk of their time. So, I suppose there is no player in the market today, Ulrich, that has witnessing time-lapse and everything that you see in front of you here at the marketplace today. We need to capitalize where we have unique positioning and sources of strategic advantage, and I think we've laid that out today.

We do believe we have a very compelling value proposition that should suit very well to the needs of the American market as it's evolving today. So look, clearly, we need to be examining all of these options as we build out our platform. But I do think we seem to be talking about time-lapse a lot, but I think time-lapse, combined with everything else that we have, gives us a strong right to win in the US. It's more around some of the additional factors in terms of feet on the street, you know, and those type of capabilities that I think are going to be more important. Yeah. Thank you for the question. I think I saw Susanna. Yeah, Susanna.

Suzana Queckbörner
Healthcare Equity Analyst, Handelsbanken

One more question. I saw on one of Carmen's slide that it said, ERA, 2.0. So I was wondering if you could provide an update on what that would be?

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Carmen, would you like to give an update on ERA 2.0? Thanks for the question, Susanna.

Carmen Rubio
VP of R&D Genetic Services, Vitrolife Group

Sure, Susanna. This is related to the non-selection study that I was presented. So we have an algorithm to predict the receptivity status according to a number of genes related to the window of implantation. The new ERA, we are testing for genes related to other important implantation processes, metabolic disorders, and immuno, alterations. So the new ERA is aiming just to incorporate another genes that are important for the implantation to allow pregnancy, not just the window of implantation. This is one side, so we can incorporate some more genes, and we are doing this under the umbrella of a serious clinical study. So we are going to see blindly, we are going to transfer the embryos without knowing the status of the ERA result.

We are going to see the patients that get pregnant, the ones that none, and we are going to check the genes that are important. So this is one side. We are incorporating new genes, and we are going to have a serious non-selection study in risk patients because there's no one now in the market. So this is the main relationship with the new ERA. New genes and important clinical study targeting very well the population. And I think that another very important thing that has not been taken into account in many of the previous ERA studies is that we were not considering the chromosomal status of the embryo. If you look at the literature, most of the publications, they are good-looking embryos, but not chromosomally tested. So we want to control for this.

We want to be the surest as possible that we are transferring a chromosomally normal embryo, and also identifying very well the population. We are really aiming to find a population with previous failures after the transfer of chromosomally normal embryos. We have preliminary results about the genes that can be important, that related to immune and metabolic alterations. So this is the idea, new genes, more clinical evidences, narrowing better the indication.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Thank you, Carmen.

Patrik Tolf
CFO, Vitrolife Group

Okay. I think we-

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Yes?

Patrik Tolf
CFO, Vitrolife Group

Mm-hmm.

Bronwyn Brophy O'Connor
CEO, Vitrolife Group

Okay. So thank you all very much. Professor Simón sends his apologies. He's running to the airport to catch his flight back to Spain. Look, just a very, very sincere thank you for taking the time to come here today. We very, very much appreciate your support, and your interest, and your investments, and your analysis of our great company. I just want to also really, really thank my incredible team. This was a herculean effort, and I'm really, really proud of the work that all of the team have done. If you do have a few more minutes, we'd absolutely love if you could pass by the marketplace. And with that, all I'd like to say is maybe to all the Swedes in the audience, I hope you have a wonderful Lucia.

I'm certainly looking forward to my first one here in Gothenburg. So, thank you all very, very much. Have a wonderful Lucia, and it sounds very strange to say this so early in December, but we also wish you all a very, very merry Christmas, which is just around the corner. So thank you. Thank you all.

Patrik Tolf
CFO, Vitrolife Group

Thank you.

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