Oxford Biomedica Aktie

Good afternoon, everyone, and welcome to OXB's Capital Markets event. I'm Aurelie Charpentier, Head of Marketing and Communications at OXB, and I'm delighted to be here with you today. For everyone joining us here, thank you for coming despite the chip strike. And to our webcast audience joining from around the world, thank you for being here.

Today, you're going to hear from OXB's senior leadership team and industry-leading voices. Let me take you through the agenda. We'll have 6 presentations broken in 2 sessions with a 15-minute break in between. First, you'll hear from our Chief Executive Officer, Dr. Frank Mathias, who will provide an overview of where OXB is at today and our market positioning.

Second, Professor Luk Vandenberghe from Harvard Medical School will join us online. He will provide an independent perspective on the current advances in cell and gene therapy and the opportunities ahead. Third, our Chief Innovation Officer, Dr. Kyriacos Mitrophanous, will show you how innovation can enable client delivery. You'll hear about next-generation platforms, AI, automation and new markets.

And fourth, our Head of Process Development, Dr. Nick Clarkson, will demonstrate how process development excellence and the client-centric approach can deliver value. We'll then have our first Q&A session of 15 minutes with these 4 speakers, followed by a 15-minute break.

After the break, you'll hear from our Chief Business Officer, Dr. Sebastien Ribault, who will take you through a deep dive into the cell and gene market opportunity, our business pipeline, our conversion rate and why clients choose OXB. Sebastien will then sit down with Arun Das for a fireside chat. Arun Das is the Chief Business Officer at Cabaletta Bio, one of our key clients. Sebastien and Arun will discuss our partnerships, why Cabaletta chose OXB and the value we deliver.

And finally, our Chief Financial Officer, Dr. Lucy Crabtree, will cover our strong financials and attractive outlook. We'll move to our second Q&A session, 30 minutes with Frank Sebastien and Lucy. Frank will then return to summarize and close the session before our drinks reception.

During the Q&A session, we'll be taking questions from the room. For our webcast audience, you can submit your questions throughout the day and we read as many as we can today for we will answer to individuals after the session if we couldn't get to the question. And with that, I will now hand over to Frank to open the session.

Thank you so much, Aurelie, and hello, everyone. Nice to see you here despite the strike. It took me 2.5 hours this morning to come from the airport. But I'm on time and I'm happy about that. So it's a pleasure to welcome you all to our Capital Market event. And we really appreciate that you took the time to come to follow this session.

So we have prepared a very nice agenda, as Aurelie just showed you, and we will share different perspectives on the company. So first, what are the market opportunities we have and we see ahead of us. Then we will discuss the progress we have made over the last few years in building a pure-play CDMO company. And then we will also try to show you why we are so confident in delivering long-term sustainable growth. But before we start and Aurelie has already mentioned it, I want also to express my gratitude to our guest to Luk Vandenberghe, who will join us virtually.

He is from our innovation and Technology Excellence Board to kind of Advisory Board to the company. And of course, to Arun Das, you presented him already Aurelie, Chief Business Officer at Cabaletta. Thank you for taking the long journey to visit us also today Das -- Arun. Thank you so much.

So let's start. And because some of you might not be -- yes, you all know this one. So please consider it. So perhaps some of you are not so familiar with what we do and what cell and gene therapy space is about. We saw some potential short slide to make it evident what kind of world, crucial world to say we play, so just in one center cell and gene therapy is a medical approach that treats diseases by modifying replacing or introducing cells and genetic material to restore -- a normal functional hedge the burden to fight illness. That's what cell and gene therapy is about.

And what you see is that this therapies are about fixing diseases at the biological source. So instead of just treating the symptom, you try to correct to replace or to add what's working not so well into the body. And this has a potential to cure. I will come back to that because I believe this is an important part to understand. So we play obviously here a central role, as you see by providing the viral vector, which you can consider to be a kind of vehicle to bring the code, the genetic material into the body. That's what we do in the middle. We just focus on the development and production of viral vectors.

So let's have a short look at the market we are in currently. And I believe it's important to mention here that what we are seeing across the cell and gene therapy market is not just a short-term cycle. It's everything but not that. It's really a sustained expansion of therapeutic pipelines across all stage of development from preclinical programs up to commercialization.

So the number of products is estimated of programs to say, it's estimated to grow, and you see that on the left-hand side here, 9% year-on-year over the next 5 years. So by doing that, they will fuel demand for high-quality manufacturing partners. What we see also in the middle is at the bottom of the middle is that currently 38 cell and gene therapy products are already approved globally.

And what we see also is that we expect a high level of development of the revenues for the outsource is on the right-hand side just outsource potential market growth, which is supposed to grow whatever source you take of data, are very similar in what they say from 4 to 10 billion in the next 5 to 6 years. So this will be 18% growth on average every year. So what we see also it's a lot of dynamics in this market. Cell and gene therapy M&A deals just in 2025 up to $12 billion in value shows that there is a lot of dynamic in this market.

Now coming to what OXB is about and I think it's important to remember that our vision is to transform lives whose synergy can tell me how, by helping and by enabling our clients to deliver life changing therapies to patients. So this shield is fundamentally shifting the paradigm of medicine moving beyond the just same treatment towards treatment with potential towards where the disease at it's source end to cure. We or the company provides them the expertise, quality and manufacturing excellence needed to translate this scientific innovation, into a scalable commercial reality.

So we have done that for more than 30 years, now we have been leading innovators in viral vector design, process optimization and large-scale manufacturing, I'm sure [indiscernible] few things about that, it's part of our long time history and today we focus on best-in-class capabilities, scalable platforms and start-of-the-art facilities. And our strategy is also very clear, we want to cell and gene therapies to be more filled as the trusted partner so an unmatched quality and innovation.

So our focus is to build long-term partnerships with leading innovators. I want to mention you, Arun here with Cabaletta Bio because I believe it's a strong example of what a good partnership can bring for the benefit of the end the patients. So if we go to a little bit of history because I believe the history is important to understand us, you might know, everything started in Oxford in 1995. It was a spin out of the Oxford University.

And over the years out from the origin at the end from the spinout, we went through a lot of progress. We achieved a lot of milestones in cell and gene therapy, and we have been consistently evolving alongside the industry itself. I believe that the most important transformation was somewhere between '20 and '22, when both of the company decided, we need to take a decision. Do we continue to do product development for our own or are we going for CDMO business, we decide to become a pureplay CDMO company and this brings us into the unique position in the field.

So this says of course required strategic clarity and execution building of a 30 years of expertise, we have continue to strengthen our global CDMO network and manufacturing footprint, so strategic investment and targeted acquisition as you know in the U.S. and in Frank will come back to that.

So by doing so we have broaden our technical capabilities across vector platforms we are today vector agnostic, we can do every kind of vector and we have builded an integrated international network and at the same time, and we'll see if we certainly report on that we will able to deliver 33% gross in full year 2025, but as we look back to 2023 we more or less even doubled our revenues within 2 years, so I believe I can say today that OXB is stronger, more focused, more scalable, more globally integrated and never before and as such will extremely well positioned to continue to capture substantial market opportunities ahead of us.

Just a few words on our global sites network as you might know, we have now facilities in U.K. in France and in U.S. and I wanted to show you how is this came together, so everything started that as I said before in Oxford in 1995, today Oxford will be our center of excellence for lengthy viral vector development and also production up to commercialization, we are also able to do other formats, but into center of excellence in U.K.

Then through the acquisition we did in 2022 of the Homology CMC part we acquired a center of excellence and we acquired a site in U.S. which we now developed to center of excellence for AAV, I believe this was important because you cannot be considered as a global company if you don't have a footprint in U.S.

At the same time and there is a little bit due to the Brexit, we also decided to make an acquisition from Acetum in France by acquiring 2 different sites, one in Lyon and one in Strasburg, and you see that the vector focus here is AAV and lentiviral vector. We can do both, but we can also do other oncolytic and MVAs in Strasburg.

And finally, and I'm sure this was a game changer. We made this acquisition last year at the end of 2025 of a site, state-of-the-art site in Durham, North Carolina, which we acquired from Resilience. And I said it already, I'm sure this was a game changer because it has increased our awareness immediately in the market. We need to know that this is fully FDA approved commercial scale facility already with additional fill and finished capacity.

So this allows us to really end-to-end offering in the United States now and the way we see both Bedford will be the center of excellence for AAV, development up to E&P and 1/6 in those E&P status will be transferred to Durham production, it's a way we see. So we are now globally in the western part of the -- at least of the world and we are able with the high level of flexibility to serve all our clients, whatever the level of their clinical development is our -- it's needs for commercial or for development we are able to do it from all the different geographies.

And as always behind everything, which is successful U.S. people, and I have to say that, yes, as you can see we have a highly experienced management team, we have highly experienced people around the different geographies and I have to say that I'm extremely proud to be working with such inspiring people around me and us, and you will hear from some of them later, from the team about what the experience are in financial market, via vector development, while vector manufacturing and the border CDMO space.

And this brings me to my last slide, little bit as an introduction to the different presentation you will see, alongside the afternoon. I believe it's important to see that our performance, the ones which we consider to be outperforming, performance 4 different pillars, they are mentioned here.

So first is our global scalable infrastructure, this is the foundation that enables us to support programs from early development up to commercialization or up to commercial supply. Second we have process development, excellence and we will show you a lot of data in this direction, when our ability to solve even very complex technical challenges. We have the third block is about our innovation led platform, which ensure that we continue to evolve and stay ahead of what the client needs, but also of what the science is doing.

And fourth, our commercial momentum, which reflect the strength of our pipeline and of our order book, and I'm sure that Sebastien will tell us a lot about that. So these are the 4 blocks, the 4 areas we're really defining how we operate and where we focus as a business.

And having said that, I would like now to introduce our first speaker today, guest speaker in this case. So I hope that Professor Luk Vandenberghe is online. He's Associate Professor at Harvard Medical School and an associate member of the Broad Institute of Harvard and MIT in Boston. Professor Vandenberghe is a leading expert in the evolution of cell and gene therapy and his lab work is focused on improving viral vector design and use.

We are very happy to have him being part of our Scientific Advisory Board. He's joining us today in a live call to discuss with us cell and gene therapies, how they are maturating and to impact a growing number of patients and the role CDMOs have to play in fulfilling the potential of this modality. So Luk, the floor is yours. I would say, in this case, the screen is yours. Thank you so much.

Thank you, Frank, for that introduction. And it's a great pleasure to be here at this event in OXB. I'm sorry, I can't be there in London with you. If we can switch over to the first slide. I was asked to provide an external perspective on the state-of-the-art in cell and gene therapy by OXB. And of course, that field of cell and gene therapy is the field that OXB is providing essential services in, as you've just heard.

At the same time, beyond from this external perspective, I am, if you will, a prototype end user of the services that OXB provides. I often seek out manufacturing services from companies like OXB and the likes. In terms of the title here, maybe if you go back to the title slide, please, gene therapy is at an inflection point. And as is usual, during periods of transition, this leads to a lack of clarity in terms of where the future trajectory leads us.

It's my goal here today to share with you where my compass points and provide you then also with some data points that informs that opinion. So on the next slide, I'll give you a brief introduction as to where I'm coming from. I'm an academic primarily with training in biochemical engineering and virology, and I live in the field of molecular medicine. Originally from Belgium, spent most of my career on the East Coast in the U.S., where I eventually became the Founding Director of a center called the Grousbeck Gene Therapy Center at Mass General Brigham in Boston, where I'm also a faculty at Harvard.

I'm an engineer by training. So most of our work really is around building technologies, designing these technologies. We study these technologies as well. But importantly, for this discussion, we try to translate these products, that last word there on the slide on the right. This process translation is building science out into drugs into the clinic.

So on the next slide, I described to you where this journey has taken me over the past 20 years on the industry side. I just talked about kind of my academic path, but I've been fortunate to see several of these technologies and experimental drugs progress through development and in one case, even the marketplace. Sometimes this happens through partnerships, like is the case with this vector kind of in the middle there, AAV9 that was incorporated into a drug Zolgensma, which Novartis sells.

And sometimes that path leads us to the creation of a new company right next to it on the right, Akouos, a hearing gene therapy company, which is leading one of our technologies to the clinic and that I still remain involved with even after its acquisition by Lilly. So on that journey of each of these programs that are listed here, a critical step is solving for your manufacturing needs. And that is a critical component all the way from the laboratory down to eventual market authorization and beyond in terms of commercial supply.

On the next slide, let us maybe try to get to the same page feel briefly here by providing you some of the key concepts in the field. And I'll try to keep it relatively clear. I don't think we need full depth to have a sufficient understanding here in terms of what gene therapy is. The goal of gene therapy is really no different than any other field of drug development. We develop drugs for diseases where there's a need to develop these drugs.

But unlike other fields in drug development. We have an active compound in that drug that is not a small molecule. It's not a protein and the traditional drugs that you're familiar with, it is a gene or it is a gene-modified cell there in the middle on the left. Why is this compelling? Why do we need a different modality than the drugs that we have? Well, cell and gene therapy has the potential to address, as I think Frank also referred to the root cause of disease.

It allows us to go after diseases that currently there are no treatments because they're technically hard to get to. And another aspect that I think speaks to the imagination, it has the potential to be durable, a onetime intervention with a lifelong benefit to the patients. There we say, and this is a word we use very carefully, in the best case scenario, a cure.

So next slide, I will highlight to you why this hasn't been done before. Well, the challenge is threefold. It's called delivery, delivery, delivery. It's basically how do we get a gene safely and efficiently into the body to have that therapeutic effect that I just talked about.

On the next slide, I'll share with you the kind of the solution that the field has come up with, and that's summarized here. The solution really is called a vector illustrated on the top right there. The vector is a vehicle that facilitates this delivery issue. It's a post fan, if you will, that shuttles in a gene to the cell.

The blueprint of a vector looks like that's there on the top right. It's got an outer shell, which is the vector and it protects and it guides the internal therapeutic cargo illustrated there in orange in the middle, and that's the gene. This vector is either applied directly to the patient in a field called in vivo gene therapy. As you can see there with the arrow circling down to the right -- to the left. And on the right, there's an intermediate step called ex vivo gene therapy, where that vector is applied to cells outside of the body, and those cells are then delivered to the patient in this field called ex vivo gene therapy.

Now OXB holds the expertise and the capabilities of producing these vectors at a purity for use in humans and at a scale to support products through testing phases and eventually into commercial. The most common vectors in use are viral vectors, and these are inspired on naturally occurring viruses, but they were neutered to eliminate the noxious features of the virus.

And 2 types you will hear throughout the presentation, you've already heard about AAV and lentiviral vectors are the most common ones, but OXB provides services in a variety of other ranges. So on the next slide, I'd like to give you just a little bit of the human element of how gene therapy, cell and gene therapy can impact lives and it's already doing so on a growing scale. I won't do it in terms of the numbers that Frank presented, but I'll do it in terms of these vignettes.

Starting on the top right, this woman Emily Whitehead. You can look her up. It's one of the first patients treated with a CAR-T cell when she is very young and suffering from an otherwise fatal pediatric cancer. Now we have several CAR-T cell therapies, as you know, available globally, and they are making a market difference for these patients.

Moving to the middle, spinal muscular atrophy, a fatal genetic disorder that leads to death often in the first few years of life. A single administration brings therapy to these patients. Now on the flanks and on the bottom here, 2 examples from sensory disorders, all the way on the bottom right, and we'll come back to that later in the presentation, hearing.

Recently, there's been an approval just about a month ago from Regeneron in this field. We have been active in this field as well. On the left here, a particular story from just a few weeks ago, this is a drug that's now one of the first gene therapies ever to be approved, Luxturna. I had the privilege of teaming up with my old mentor, Gene Bennett, the woman who developed this drug and eventually brought it to a company to Roche and Novartis to commercialize it.

Here, we were reunited with one of the first patients who delivered who got -- who received the drug in both of his eyes when he was 9 years old. I was a translator and helped during the surgeries. And now I met him when he was 26-year old at a celebration event for Gene and Al, husband and wife who developed this and really a remarkable story. This was not a cure. You can see the cane there that he's holding, but he gave testimony, Yannick, his name is, of how this changed his life to lead an independent productive life. He's a psychologist now. He went through a career path, found a partner and is now living independently and working in a professional context, something that would not have been possible without this drug that gave him back his science.

As a small vignette, just 2 weeks after this event now a month ago, Gene and Al, together with the team of Luxturna received what's called the Oscars of Science. This is the breakthrough prize in sciences given out in California by Sergey Brins and the Zuckerberg a $3 million award.

In any case, in the next slide, let's go back to the science here. And this is just a brief iteration of the 50-year-old history of the field. This is not a -- while this is an innovative and ambitious field, went through various stages since the '70s, foundations that were laid, first steps that were taken, some stumbles in the early 2000s.

And now -- and this is going back to the title of the talk, pivoting from a stage of maturity. We have drugs that work. We have technologies that work to some extent, but we're really now transitioning into this industrialization phase. And that is one of the pieces of that inflection point that I described to my time. So let's go into the inflection point and what's behind it in the next slide.

Indeed one where we now have all of these things that have happened, overall, quite good things, validation of the science behind this ambitious field, annual markets north of $1 billion of certain drugs, dramatic clinical outcomes, increasing investment and acquisitions in areas like CAR-T, neuromuscular and ophthalmology. But we also see clear signs of hesitation, commercial hesitation. And these have to do with safety events.

These have to do with pricing. These have to do with market access. And these are legitimate, I would say. These are concerns that are legitimate. I'm not here to kind of gloss over those and tell you that these are over reactions. No, there is a real reason between -- behind this moderation.

However, I would be remiss to not highlight the clear opportunity that's there as well and particularly that is sometimes overlooked in this window of time. The opportunity stems from the fact that the investments of an era of exuberance, and this is probably an era somewhere from the 2015 to a few years ago, where massive amount of investments have led to scientific and commercial hurdles that have been dramatically overcome and that now the field is really primed to have an expanded impact in terms of biopharma.

So in the next slide, let me walk you through some data points behind this. The first generation of cell and gene therapies has identified several limitations in terms of delivery, the types of cargo we can deliver and how we bring those to patients. But as I mentioned, a lot of these areas have been significantly matured because of the technologies that have been invested in.

So in the next slide, I'll give you a few short vignettes, and I'll briefly guide you through the scientific slide is actually some of our own data. And I understand not all of you are scientists. It's my full intent to make you a scientist by the end of this talk, so bear with me. But let me point you to actually the scientific slides, the histology on the right there.

There, you see 2 columns, liver and muscle, and you see 3 generations affected. I'll briefly walk you through it. When there's more brown there, it means that the targeting was effective. When there's little brown, it means that it was not effective. I tell you now that muscle drugs that are emerging today and coming on the market have been based on this first-generation vector that we see there. Barely actually reaches the muscle, largely gets trapped in the liver.

That investment that I talked about before has led to several parties developing a second-generation vector that at least gets you in the muscle significantly better. And then a third generation that shows that you can actually delete the liver where it doesn't even belong when you develop a muscle drug. So we are now -- we have an uncanny ability to target these innovative medicine. And what it does is it effectively overcomes some of the main issues.

Two issues are that because of this limited capability of that first generation, we have to dose massive doses to the patients. That leads to high cost of goods and toxicity. And guess where that toxicity shows up in the liver. So you can imagine the impact that a third-generation vector could have for diseases like Duchenne muscular dystrophy.

Next slide, just very briefly, a similar effort is ongoing in terms of the target, what goes on. So not the vector on the outside, that outer shell, but also what goes inside. Up until a few years ago, we could really only do this gene augmentation approach. But I'm sure you've heard of things like CRISPR and so forth. We now have abilities like gene editing, RNA-based approaches, sophisticated ways to control genetically where our target goes. And that is really because of a revolution in molecular medicine.

In the next slide, I want to make the point that the opportunity goes beyond the science. Because of the appeal of gene therapy, the impact it has on patients, there's been large incentives to accelerate this modality. These incentives have come from drug makers, regulators and investors. And they have led to accelerated pathways for approval, potential for expansions earlier than many other modalities, a probability of success in terms of development, the risk that one takes early versus later in development is lower and it's increasingly dropping because of the experience we gain. And it's lower compared to other modalities.

So that means faster approvals, earlier access because of these faster approvals to the need to commercialize and the preparation for commercial license. And this brings us back to OXB, CMC that needs this manufacturing piece needs an early attention. So in the next slide, 2 brief vignettes in terms of support, and then I'll round off.

Here is that probability of success that I referred to. Compared to a small molecule on the right, there's these relatively modest but real increases of probability of success, particularly early in the pipeline. You can see, for example, a CAR-T cell has about double the likelihood of success all the way to approval compared to a small molecule. And that has -- we know why that is. That's because we use tweezers rather than hammers in this modality. We know the biology of disease that we target better than often with a small molecule drug, and we're learning as we're going.

So in the next slide, I'll come back to some of these regulatory pieces and the importance of manufacturing, that manufacturing or that CMC piece. Regulators used to go around in meetings and talk -- make statements like 50% of a gene therapy drug is CMC. And that's not the case for a small molecule. That is the case for a gene therapy because of the complexity of the drug compounds.

And when you ask sponsors here in a survey organized by Jefferies and published last year, sponsors see as key execution risk, 2 areas that directly land back into a CDMO, product quality and CDMO. These are critical path in terms of quality and in terms of time line for any drug development, and I can testify to that from my own experience.

Now the last slide in the next one, what is so important. So in the next slide, what is so important in terms of what a CDMO delivers. It's quite a lot. We're asking the CDMO to really optimize parameters in terms of speed, in terms of scale, in terms of robustness. But conversely, we also expect them to be flexible. And the only way to achieve that really is to do that with a deep level of specialization and a party like OXB has a track record of the level of focus in the cell and gene therapy space that now goes back, I think, more than a decade plus.

So with that, I'll leave you here. And in the next slide, I'll ask for questions that I'm happy to address in the Q&A session a little bit later. But thank you for your attention.

Thank you, Professor Vandenberghe, for this valuable scientific and industry context. A key takeaway is the importance of manufacturing for the success of cell and gene therapies. Speed, scale, robustness, flexibility are key enablers for these therapies to reach the patients.

And that's exactly where our next session is going to take us. I'll hand over now to our Chief Innovation Officer, Dr. Kyriacos Mitrophanous, who will explain how innovation can help us to address these challenges, how we can create competitive differentiation and enable the next wave of therapies.

Thanks Aurelie and thank you, Luk, for that very insightful presentation. So I'm Kyriacos Mitrophanous. I'm the Chief Innovation Officer at OXB. I've been working in cell and gene therapy for over 30 years, and I manage a team working in innovation in vector engineering, cell engineering, process development, AI and analytics.

Over the next 15 minutes, I want to explain why innovation is not a nice to have for a cell and gene therapy CDMO. It is critical for our future success that we stay at the cutting edge of this growing and exciting field, as you've just heard.

So why is innovation critical for CDMO? Well, the technology is still developing. Unlike biologics, cell and gene therapy processes have not yet been commoditized, making vector to the scale that we need and to the purity that we need, this is still an ongoing challenge. The regulators are continuing to raise the bar in terms of the purity and quality of the vectors that are generated and clients' needs are more sophisticated.

In the past, they were expecting a CDMO to provide all the different technologies and processes. But increasingly, pharma companies have got internal capabilities in this area. So they are coming to CDMOs to obtain additional capabilities that they don't have internally. And finally, it's not -- developments in cell and gene therapy have not finished. We hear about in vivo CAR-T. We have heard from Luk on AAV targeted vectors, gene editing, all these different technologies are coming in.

If we don't innovate in these areas, then we won't be able to be part of that -- those developments. So we look to see which areas we should innovate in. We talk to clients. We talk to industry leaders, and we identified these 5 key areas. The first one is tighter. So how much vector do we make in a batch, the yield. The more vector we can make, the better the cost of goods, the better the cost per dose for that particular product.

The next one is speed. Clients want a batch made and released as quickly as possible, and they want that batch to be as affordable as possible. Then robustness. For every new trans gene that a client will bring, can our processes generate high-quality, high amounts of vector? Can our platform achieve that?

And finally, quality, when we are making batches again and again, do we meet the specifications? Do we meet the tighter expectations and the impurity profile to allow those batches to be released and used in the clinic without interruption. And in terms of the 2 vector systems that, as Luk mentioned, we are focused on lenti and AAV in terms of titer and speed, we are best-in-class in terms of pricing, we are competitive in terms of robustness, top tier and in terms of the quality of the vector that we generate, again, best-in-class.

Now the reason we have those achievements is because of the innovation we've done over the years. These are some of the technologies we've developed over time. I'm not going to go through the whole list. Just to name a few. So Tetravector, this is our fourth-generation lentiviral vector system. It has increased capacity. It gives higher titer, higher expression and has additional safety features.

For AAV, we have our Innovate system. This uses a dual plasmid production, a simplified version to allow better ease for production. And it's married to a downstream purification process that allows us to have best-in-class AAV420. We're getting 90% from this particular technology that OXB has developed.

So where do we see cell and gene therapy going in the future? Well, there are 4 main areas. We have AI and automation, how can we use digital tools to improve how we work and speed up our processes. Next, as we've heard from Luk, AAV targeted vectors. These vectors are targeted to specific cell types or tissues and away from organs that are sensitive such as the liver. This opens up new avenues, new therapeutic opportunities.

Next, we have lentiviral vectors used in vivo for CAR-T therapy. So CAR-T therapy, autologous CAR-T therapy has been very successful, but it is cumbersome and complicated. The patient cells are patient's blood is taken, cells are purified, -- they're shipped to GMP facilities that are limited in their number. Those cells are turned into CAR-Ts with viral vector and then administered into patients that have been often lymphodepleted.

This means that only a subset of patients can benefit from this. If we can instead switch to an in vivo lenti, so a vector that has been engineered to only bind to T cells after administration into a patient, then it becomes an off-the-shelf product and many more patients can benefit.

And finally, we have new modalities such as nonviral vectors, LNPs that can mediate gene editing and transient expression. They can achieve things that viral vectors are -- they can achieve therapeutic benefit that viral vectors can't, for example, repeat dosing and delivery of larger payloads. So in terms of the -- our digital tools, we -- at OXB, we work in a number of different areas for bringing in digital tools.

I'm going to describe some of these. So we have digitized lab analysis. So moving away from manual Excel workflows to automated analysis and real-time dashboards. We're also using predicted scale up performance. So using the data we've accumulated over many years to understand better what are the critical parameters for our processes. So can we predict when a client brings in a new gene, a new product, what kind of titer we will achieve and what level of impurities will be -- are likely to -- we see in that product.

This will allow us to -- allows us to condense the development time that we do in the labs, and Nick will talk more about that in a minute. So I won't go through the rest, but these different digital tools allow us to achieve higher operational efficiency. It allows us to reduce the errors, the number of deviation, each deviation means additional work. So limiting those makes us more efficient and faster. We get a stronger understanding of processes and are able to make better, faster informed decisions. For our clients, it allows faster program delivery, lower development and manufacturing risk, greater transparency and stronger regulatory documentation.

So as I mentioned, in vivo CAR-T is an exciting new area. From a manufacturing perspective, we see 3 main challenges. One is vector quantity. If more patients can be treated, can we make -- we're going to need to make a lot more vector. At the moment, only about, as I said, 20% of patients are benefiting from CAR-T therapy where it's available.

Next, the vector quality. This -- for in vivo use, we want to minimize the impurity profile, so reduced host cell DNA, reduced plasmid DNA, reduced host cell proteins. One other important aspect is vector particles are made -- there's a mixture of active and inactive particles. Can we maximize the number of active particles so fewer particles can be administered into a patient to elicit the benefit, the efficacy from these therapies.

The fewer the particles that are administered, the less it's likely that a patient will develop antiviral immune responses, which will be a key parameter for the rollout of these technologies. And finally, vector complexity. So these vector particles will have proteins on their surface for specific targeting that have proteins that allow immune modification, cloaking and also T-cell activation.

And at OXB, the technologies we've been developing over the last few years can address some of these needs. So we have a 400-liter large-scale perfused bioreactor. This gives us higher titer with reduced impurities. We have additives that improve the potency, make more vector particles and more active particles. And we have a lot of experience with the different envelopes that are likely to be used by clients for in vivo CAR-T.

So what we've seen a surge in clinical trials and in product development for in vivo cell therapies. As of March this year, there are 112 in development. 74% of these are in CAR-T. 33% are using lentiviral vectors and 47% are using LNPs. LNPs are being used primarily for autoimmune disease and lentiviral vectors are for cancer.

Interestingly, many of these are still in the preclinical or discovery stage, 55 and 34. This means that it's going to be a few years yet before these are commercially successful. So OXB is there to help be part of that. And finally, the nonviral space. So as a company, we have some experience in this. So this is a rapidly growing modality.

Clients are not viral vector or nonviral anymore. They tend to be both, and they choose CDMOs based on the ability to deliver for both of these. The clinical data that we've seen for using these modalities has been compelling. And OXB capabilities, we have experience with viral vectors, viral-like particles, our GMP facilities, our processes, our capabilities in process development, analytical development are readily transferable to these nonviral systems. So it's an opportunity for us to enter new markets which helps protect our revenues. It derisks cannibalization and allows us to secure new partnerships.

So in summary, I hope I've shown you that innovation for a cell and gene therapy CDMO is a must and that we've established innovation processes and governance that we're doing essentially the innovation that matters to clients. We have a culture of scientific excellence and our scientists are very skilled in terms of the biological processes underlying vector production and purification and are able to solve the problems that clients bring to us.

We have an unrivaled track record in innovation. We've got a strong intellectual property position and deep technical expertise. And this creates a competitive moat across the company. So that nicely brings me to an end of my section. And now I'll hand over to Nick, who will tell us about how we help clients help patients.

Thank you, Kyri. It's a great reminder of how important innovation is to our success and also the success of our clients. So I'm quite new to this. So for those who don't know me, I'm Nick Clarkson. I'm the Head of Process and Analytical Development at OXB. We kind of term it as development services.

Now the group consists of about 100 scientists and process engineers, very client focused. We're often the very first team that a client once they're onboarded to OXB, they make contact with us, and we actually guide them from those very initial early stages all the way through to whatever outcome, usually commercial applications and licensing.

So before I go through the presentation, because I'm new, I was going to tell you a little bit about my background. I've been at OXB for 12 years. I have worked in innovation. I've worked in analytics and most recently, I'm in process development. It sounds like a long time, but it's a great place to work, very inspirational, especially when you see the impact that you have on patient lives. Prior to that, I was working in immunology, analytics, and I spent many years in Oxford University studying immunology and T-cell biology. So it was a great grounding for the kind of work that you've been seeing today.

So I was going to give you a little bit of background about process development and analytical development where it really sits. It kind of sits between innovation and manufacturing. So with that where the commercial journey starts really with the client. So we take clients on board. We can do feasibility studies. We can do all the preclinical development, and this can be anywhere from construct plasmid design, cell line development, even cell banking. And we follow the client through Phase I, Phase II, optimizing the process all the way up to Phase III and commercial. And the important Phase III and commercial, we actually perform analytical method validation and process characterization, which is part of the process validation.

And this is something that we need to do before they apply for a BLA or MMA and get their licensing. So what really makes us unique? It's -- again, it's going back to 30 years of experience and the depth of knowledge that the team have. So combination of innovation and process development, we have amazing in-house expertise in virology and molecular biology. And I think this is probably unrivaled in many of the CDMOs. And this is really born from product development, transitioning into the pure-play CDMO.

We've retained that knowledge so we can actually help our clients develop their vector and their product and offer advice on how to get the best results. We have great small-scale development for optimization, and this is really where we can try out our new technologies from innovation. So we can tailor it to how -- for a client need. So we can try different sort of enhancers or vector backbones, really just to optimize depending on what the target product profile is.

We have qualified scale-down models. Now these are sort of smaller versions of what you would see in the manufacturing. So we can accurately determine how it's going to perform in a manufacturing setting, but without having to do the very large-scale runs, which are very costly and expensive. We leverage a lot of our data because we have a very robust and consistent platform across AAV and LV.

So this is really a great benefit to our clients, and I'll explain a little bit later how this helps them out. But really key to this is the collaboration and how we work with the clients. It's central. We're almost an extension of an R&D team of our clients, and we can be very flexible and tailor our approach according to their needs.

So an example of this really is not one size fits all when it comes to process development. We have different clients. They're very diverse. Some are very early phase small biotechs. So responding to that market need, we have a faster GMP offering, and this is sort of a fast-track route. It's leveraging a lot of our data that we know our platform, there's minimum development. We can go from a very small scale to like 250 mls. We can go straight up to a pilot to 50 and then into GMP, and we can do this in a relatively short time.

And this is really leveraging our knowledge of the platform. It may not be the fully optimized for yield or tighter as we call it, but your quality is going to be good, and it's the quickest way that a small biotech will get it. And to them, quite often, time is everything. They want that first clinical batch very quickly.

Kind of in the middle is like a derisked GMP, where we'll do the small-scale studies, and we may do an SDM where we can optimize some parameters. This is really trying to halfway house, getting improvements in yield before we really go into the sort of pilot and the manufacturing. And the last one is the full optimization. And this is really most popular with the well-established pharma and biotechs.

We can do multiple rounds of development. So we'll do the small-scale development. We can move up into the scale-down model with 10 liter. We take that data and they may want to go back to the small scale and try different things. So it's kind of an iterative process. The benefit really of the full optimization for the big pharmas is they can take that data forward with them when they go to commercial. So they'll have a plan -- long-term plan of how they want to get to the commercial, and they can use that data later on in their process characterization.

So this is just an example of the faster GMP offering, and it really gives you a sense of how we can cut down from our standard time lines. So for the LV, a standard time line can be 16 months. This is from a client initially making contact with us signing up until they get their first GMP batch. Leveraging that knowledge, leveraging our data, we can really take that down to 9 months. So it is very rapid indeed, and that's releasing the batch.

For AAV, it's a little bit quicker. It's quicker because the processes are slightly different between AAV and LV, but we can really get that down to sort of 7 and 9 months, which is industry-leading really in that time. Some of it is skipping engineering batch, but the common theme about this, this is our experience coming through there. We know what are the critical parameters. We know what we can not take shortcuts, but we can accelerate and still give that same quality to the client.

So going faster GMP is just one thing, but with our knowledge, we can actually deliver innovation quicker. So coming from Kyri's team, this is an example of innovation. So we work so closely together the teams that we know exactly what's coming out of the innovation department into the process development.

Now this is an example of a change that we did to our downstream processing. So you probably all appreciate that yield is everything. And historically, in LV, it was quite low. We had a new downstream processing. It's an ion exchange resin. And this increased our yield about threefold. So you're getting 3x as much product at the end of your processing.

Now it was in innovation, and we were challenged by a client, can we adopt this technology very quickly. They had a very important program. So we took it from innovation through process development into GMP in 6 months. This was an amazing feat for us. The actual results. These are real results. It was a threefold increase. It was improved quality of the vector. And what it really meant for OXB is that we gain the trust of that client, and we gain their business for a key client going forward.

How do we do it so quickly though? This really comes back to the innovation and how we employ that in our development in our manufacturing. So we use statistical -- I can't pronounce it statistical approaches to determine how inputs affect our process. Now this is what we call design of experiments. It's kind of a very basic AI for people that don't know. AI really is just very advanced statistics. But the design of experiments, it uses statistics to accurately predict what's going to affect our process.

So what this means we can study multiple parameters or inputs, we call it at once. So doing 1 or 2 is quite time consuming in a lab, we can do 10, we can do 100, and that's by utilizing the automation that Kyri was talking about earlier. So we can do multiple inputs simultaneously and really drill down and get a better understanding of how this technology is going to improve us.

What it means for the clients, fewer experiments. We can do things quicker. We can leverage certain software and programs to sort of better predict what's going to happen. You get faster onboarding and progression to process characterization faster to GMP. But particularly important really is the robustness of these automated processes. When you're doing these kind of development works, if you're not robust, the development kind of means nothing, and we're very good and we're very robust at doing that.

And what it means really for OXB is we can service more clients, and it really reinforces us in our market-leading position going forward. So we talked about faster GMP, and we talked about innovation. Another really important thing for us is our derisking that path to commercial. And I think this is one of our real strengths. Our in-depth knowledge and our experience really shows through when we're working with our clients.

What I mean by commercialization is taking the product from the sort of development phase and validating that process so that they can go for a biologics license application or a medicines marketing authorization. We do this very well. We have -- the previous slide, you saw we've done about 10 of these process characterizations, which I think is probably more than any other CDMO in the market for viral vectors.

We have standardized templates. We have the platform knowledge that we can leverage. We have the qualified scale-down models, and we have that extensive process characterization experience. What this means is that we can really accelerate this process and the clients have confidence in us, faster development times, lower development costs. And really, what it's setting OXB is we're kind of the go-to CDMO now for these late-stage commercial programs like the go-to CDMO because a lot of the other CDMOs do not have this experience. So it's kind of a sure bet if you go with OXB. And this is just an example of what we can do.

So when you're going through a commercialization process or process validation, it's very time consuming. There's very long time lines. There's a very high experimental burden. It's very costly to the clients. So what we do at OXB, we take this leveraging historical process data where we can approach. And this is always in conjunction with the client. So we can focus on the parameters that we know to be genuine and really will impact our process.

And we will exclude some of the well-characterized or well understood processes. This means we focused all of our energy on areas where the regulators are going to actually put more scrutiny. The impacts we get the accelerated commercialization time lines. Here, we've taken 6 months off of a program. That's half a year off of a commercial program, which is a big deal for a company trying to take their drug to market.

It's reduced resource and reduced development costs. And it's just a more efficient way of working. But what we don't compromise on is quality. And I think this is, again, what's really setting us apart. We have that trust of the clients. They see our track record going forward, and they know we can deliver when we say we'll deliver.

So just summing up, again, it's going back to this client-centric model. It all comes from our track record. This 30 years of experience is really incredible. There's the unrivaled technical excellence and deep knowledge of the vector platforms means we can do things that others can't in the field. We have that flexibility that you've seen. We can tailor our approach to the client. We can accelerate or we can go more in depth for the client.

And that extensive commercialization experience really is key, I think, going into these later stages as more of the drugs are actually entering those phases, we're in a prime position to really capitalize on those. And it's shown through our repeat business. So client satisfaction is very high. So where we have clients with multiple assets in their portfolio, we tend to get those as well. So it's that repeat business, particularly going into the late phases.

So I hope that gave you a little more insight into our process development and excellence, client centricity. And I'll hand back to Aurelie.

Thank you, Nick, for this clear and practical overview of process development. The message is clear. Process development is not just a step toward manufacturing. It's a critical lever for speed as well as cost and risk reduction. And it can become a competitive advantage when a platform approach like OXBs can cut time to GMP by 6 months.

We'll move on now to our Q&A session, slightly shorter than initially planned, but don't worry, there will be another session. We'll start by questions from the room. If you have a question, please raise your hand, wait for the microphone, state your name and organization and also a speaker. I invite to the seat Nick, and Frank. And we also have Lucy, who is also available for questions.

This is Charles Weston from RBC. Two, please. First of all, Nick, you mentioned the process development time lines and the process characterization time lines, you described as best-in-class. Are those -- I guess, how confident are you that they are best-in-class? Are they key characteristics that win new business, perhaps also to Sebastien in terms of how commercial that offer is?

And the second question, Kyri, you mentioned LNPs quite a bit as another modality alongside viral vectors. Again, I'm not sure who the right person to answer this is, but would it be an important development for OXB to be able to offer those sorts of technologies alongside viral vectors?

Right. Well, I'll start. We are best-in-class when it comes to the commercialization. We've done 10 of these process characterizations. Not all of them have gone to commercial yet. Some are in progress, some are other things happened. We've never had negative feedback from a regulator or a client on our approach to this process characterization and that whole approach.

So I really do think we are best-in-class, and we do get the repeat business from clients that have gone through the process with us and they're putting more assets our way. I don't know if Sebastien wants to add.

Yes. So, it works. Yes. Thank you. So talking about the timing, how critical is that to win business was your question. The experience in process characterization tells you what you must do and what you can skip because we have the data coming to the platform.

You know that because you've done it not just once, but 3, 4 times, you've discussed with EMA, MH or FDA, and they tell you that's fine. That can come from the platform, you can skip that step and this set of data you generate. For the reason that Nick just mentioned, we've done that 10 times. One of the Phase III programs on which we were approached 2 years ago, the question was how fast can you do that?

And the standard time line is usually between 18 and 24 months, and they said, if you can do it in 12 months, we work with you. We don't even question other CMOs, we go with you directly. We started the onboarding 12 months after we had delivered the GMP batch. We had used the platform data for the discussions with FDA, went very well.

It's part of the 10 now. Soon it's going to be history and waiting for the final approval, and we'll tick the box of another commercial product with OXB very soon. So it's critical to the point where people can come to you and say, you've done it before, can you even be faster? The answer is yes, because of automation, because of new tools coming from innovation and again, because we've done it before on time in full. So it's indeed critical to the business.

And perhaps let me add on this question about best-in-class. I like your answer, but that's the answer which we get also from our clients. So it's not coming out of the blue. It's really what clients are telling us -- and this is coming back to the 30 years of experience that we bring on the table. And because we just focus on viral vectors, we just do that. We are probably able to deliver the best service possible.

And with regards to your -- does that answer your first question? With regard to your LNP question, so we are now getting clients who have both modalities and they're asking us, you've done a great job on the viral vectors. Can you help us with the our LNP need?

And we're seeing in terms of the new products coming through a mixture. So sometimes you're seeing a combination of LNPs and lenti, AAV and lenti, viral-like particles. So being able to be in both viral and nonviral should allow us to help these products that are a combination as well as viral vector pure or LNP.

So he's our Chief of Innovation. So he's ahead of us, yes. But I want to mention for now, we do viral vector. It's fair to say, Kyri, that we look at non-viral, but probably not in the next 6 to 12 months for sure. But perhaps Sebastien, you can address the point in your presentation later on where we are with non-viral.

It's Miles Dixon from Peel Hunt. If I can just return to the -- Kyri, it was the grid that you presented on the metrics, the quality, the yields, the pricing. On pricing, you said competitive. Is that competitive adjusted for the quality and the yield and the tighter? Or is it just competitive on an absolute basis?

I'll refer that to Sebastien.

Thank you, Kyri. It's -- so when we're talking about competitive, Kyri's example was about what we would consider the final product. In the end, the cost per dose, which is the cost per patient must be competitive. I'm not just in charge of the business activities. I'm a scientist myself.

So comparing data to data, I would say, if we look at the cost per dose strictly, we're very competitive. If I look at the prices of the services we offer, we are indeed competitive. But the prices of the services we offer include the process development activities, the manufacturing of clinical scale, the manufacturing of commercial scale. The cost per dose is only commercial manufacturing, where we enjoy some benefits of the development through the robustness of the process.

Process development is -- we have a lot of uncertainties that we face. I mean sometimes you have to change. So you understand what the budget should look like, but you will see variations. On commercial manufacturing, you don't see variation. You run a batch and then another batch and a third batch and a fourth and so on.

So we know it's robust, and we know that we can deliver cost per dose that some of our clients in the recent years, I'm going to talk about the past 2 years have considered aggressive, and we've reached the target that they fixed. And that's why I can say very competitive if we look at the cost per dose. Cost, price is a different story.

It's David at Berenberg. I just wondered just sort of broad brush comments about whether you've seen any changes to your competitive position recently. So have the key qualities that clients have valued changed over the last several years. So whether we'd be talking speed versus process development versus regulatory assistance versus house QC versus geography. I'm just wondering how you've seen that evolve, please?

You want to...

I can take it.

Yes, sure.

So we've seen an improvement in all 3. So one of the biggest things clients used to ask was yield several years ago. We're very competitive on the yield. You saw from the slide, we've improved it over threefold now with our new process. And the other point was speed. Now we've cracked the yield, the speed is really becoming critical.

And I think every program who wants to take a long time to get the drug to market. So the pressures are there really for speed going forward, and that's why we're really leveraging the data and constantly improving what we can do going forward. So I think that's how we're staying ahead of the curve really against our competitors. And I think we hope to remain there going forward.

We'll take one more question. Don't worry if there will be time for a second Q&A.

Kane Slutzkin, Deutsche. With therapies potentially moving sort of into earlier lines of treatment and patient populations expanding, how should we sort of think about sort of vector demand growth? Is it sort of broadly linear to patient growth? Or how should we think about that?

Very good question, Sebastien. You are the nearest to the client, but it's an interesting question.

It's a difficult question, actually. I would love to have Arun's point of view on how the dynamic is evolving. But seen from my window, it's not linear at all. Because I would say, first, we are not working in a global environment from a regulatory standpoint. If you file with FDA, you file for U.S.A. If you file with EMA, you file for Europe, excluding U.K. So you have to file with MHI to be in U.K.

And we're working on drugs, commercial, approved in the U.S., where our clients are looking at some countries in Middle East, some countries in Asia, some countries in Europe, not even all of Europe, which means that you're going to see the progression by step. It's approved in one country. And let's say that because it's one of these countries where at the very same time, they grow their biologics and cell and gene therapy markets.

It's going to be adopted very quickly as a second line of treatment, for example, when cell and gene therapy is not as a standard a second line of treatment in the rest of the world. Most of the time, it's a third or fourth line of treatment. So for me, it's not linear. It's really a stepwise approach. If it was truly global, if we had alignment between the countries and the regulatory bodies, that could be, but we're not there yet. We'll discuss that question later.

We're taking one question from the room. So how do you balance the inherent bespoke nature of each client program you mentioned to maximize safety and other metrics with the need for a more commoditized offering that drives a lower cost of goods and hence, higher margins?

Sebastien, this one is for you.

There's a second part. Do you want it now. If process intensification sustainably improves yields, how much of economic benefit is retained by OXB versus passed on to the client to improve that competitiveness you have discussed?

Where should I start? I'm actually going to take it as one question. There are solutions today to go extremely fast to a first batch. Does it mean that all our clients are going to accept that solution? The answer is no. So when we talk about the cost of developing and the cost of manufacturing, you need to look at these costs through the lens of each client objective. Some clients from the very beginning say, I want a cost per dose that is the lowest possible.

And Nick will tell you that if we -- and Kyri actually will tell you, if you want to go to the lowest, you need to develop a stable cell line, which is part of the efficiencies that we discussed in the second part of the question. It's going to take more time, though. Is it going to take more budget? If you take the overall process development budget, not really. But it's going to take another 6 months to 1 year, depending on the difficulty of creating the cell line.

But the cost per dose in the end is probably going to be divided by 3 to even 10, if you decide finally process intensification to run not at 200 liter, which is more or less the standard in gene therapy today, but you decide to run at 1,000 liter, which we can do as well. So if you combine from the very beginning in your strategy, the cell line development and the final scale-up, we will pass all these benefits to the client, and I will come back on the why in a minute.

We intensify the process. We run at a larger scale. It's not increasing significantly the cost of process development and early-stage manufacturing and the benefits are huge in the end. Why do we want to pass these benefits to the client? Because -- and Nick said it in one of his presentation, the client was very happy with what we delivered. Now we have recurrent business with this client, exactly for this reason.

If the client is happy with us, we'll get #2, #3, #4. And when the fourth line of treatment will become third line and then second line, all that volume will be with us, which means that if passing the efficiencies to the client is seen by many analysts as we're losing value for OXB. No, no, no. midterm, there's a huge value for OXB, and we want to capitalize on that value.

Thank you, Sebastien. Thank you to everyone who asked a question, and thank you to our speakers. We'll now take 10 minutes break. See you back there at 3:30 sharp. So we are not late. Thank you.

[Break]

Welcome back. My name is Sebastien Ribault. I joined the company 3.5 years ago as Chief Business Officer, spent pretty much 15% of my career on the technical side. Starting as a gene therapy scientist before what Luk presented, first casualty in gene therapy in 1999 that pretty much killed the efforts in gene therapy during 10 years. Good to see that the field is back in the last 15 years of my career on the business side, including activities with a fairly large services business, where I was heading a business unit in charge of cell and gene therapy and biologics.

I'm going to drive you today through our pipeline, how we grew our client base and tell you a bit about how we convert our proposals into a real contract and how that is translated into the day-to-day activity at OXB. It's going to be the first part of my section, and then I will tell you not only why the clients -- how the clients choose a CDMO, why they choose OXB, why they stay with OXB, but my opinion may be interesting, but it will be much more relevant to have Arun's opinion through the fireside chat that will follow immediately my presentation.

Frank presented the space in which we play, viral vectors. And we often associate viral vectors and cell and gene therapy, which is wrong. Cell therapy is one area where sometimes you are not using vectors, which actually you will see here on that slide as cell therapy. We use a vector when we modify the cells. You can also use nonviral vectors to modify the cells. They are flagged here as only one segment, the RNAi gene therapy.

So we play in a field that is relatively complex when we say CGT. We actually play in gene therapy, including the gene-modified cell therapy. And if you look at that field, I often read, including actually this morning, comments saying the field is depressed. The field is growing, but it's much slower than what it was in the past.

Well, I would actually disagree. We still see the field growing 35% year-on-year, as you see it there. And we play in 3 segments: the gene-modified cell therapy, the gene therapy and the oncolytic virus space where we play. As you see, that's the majority of this business. And here, it's not just the viral vector numbers that we're looking at, just to be clear, it's the entire field of cell and gene therapy, but fast-growing market very, very clearly.

Now if you look at the viral vector space only, there's often a question how much are you afraid of companies investing in their own capacity for manufacturing? We are not. And you see here the trend 2025, we estimate -- well, the market studies estimate that 75% of the activities are outsourced. If we go to 5 years from now, we estimate that up to 80% of the activities will be fully outsourced. Why?

We talked about it just before, cost of goods. If you want to make sure that you have a cost per dose and cost of goods that are low, you need to use the facility at their max capacity. If you run one program only and you make 10 batches per year, there is no way you use a facility at its capacity. You need to be manufacturing hundreds of batches per year. And even regulatory agencies like FDA have recommended that the biotech and pharma of this world work with CDMOs to make sure that the capacity is used and that the costs are going down.

So it's a very complex field as we know, reason why my colleagues emphasize the 30 years of experience of the company. You are successful in manufacturing only if you've developed the right process. It takes a few years to have this experience. If we go now, into the field in a bit more details similar to the comment on the field is depressed, I here many times, what about funding. How is the funding situation. Are you afraid that this programs won't progress?

Well factually speaking comparison between Q1 '25 and Q1 '26 although the number of programs in gene therapy here is stable. 2100 programs, what has changed though is that the pre-clinical stage where you want feasibility studies, you check if your gene of interest combined to the vector have the effects that you expect. This segment is indeed going down from 1400 to let's say a 1300 here.

But the other segments, Phase I, Phase II, Phase III and pre-registrations are the ones that are going, which means that the field is gaining in maturity. And that's the reason why we've seen in the first years of gene therapy, very few programs being adopted. And now we see 5 to 10 programs being adopted every year, which has a big impact for CDMOs. It means that the routine manufacturing is needed. It means that the process characterization capabilities and capacity that Nick mentioned earlier, where we make sure that the program is robust, that is needed, which means that we are running more Phase I, more Phase II and more Phase III batches.

And for a CDMO, that's exactly where our business should be. We should be developing programs where the feasibility has shown that we have valid candidates. We should be manufacturing the batches and making sure that these products become commercial and are going to be accessible to patients.

Gene therapy is about 50% of the entire field. And if I look at the past 3 years, it's been pretty stable. There's often that question, are you afraid of a complete replacement of the viral space by the nonviral space? Well, actually, RNA is here, and it's been pretty stable as well. So they coexist, but we don't see one replacing the other. That's why we believe that viral vectors have many years in front of them. Although as Kyri mentioned earlier, we're looking into the nonviral space to be ready to invest when the time will come.

Moving from the market to the Oxford Biomedica pipeline now. 3 years ago, we were a lentivirus vector company, and the pipeline was 90% lenti. We had a few AAV programs couple of Adeno virus opportunities as well, if you look at the pipeline as it is now, on the left side here. You see that for the very first time in 2026, we have these on more easy opportunities then lenti.

Result of the one OXB strategy where we acquired experienced expertise and a platform in the AAV space, when the company acquired the site we are in Braintree at Massachusetts, we developed our customer base in AAV and that's why today we see on power AAV, lenti. We have also made sure that we were diversifying the pipeline in terms of clinical phase or commercial phase where we work and you see that we have almost 20% of our activities in terms of distribution of opportunities in the commercial space, and 11% in phase III, meaning that about 1/3 of the opportunities on which we work today are revenues with recurrent manufacturing, Phase III preparation of the commercial introduction and commercial manufacturing as well.

We still keep about 1/3 of the activities in the preclinical space because we want to make sure that we support our existing clients. We have new programs that they want to develop and also our emerging biotechs or small biotechs who come to us saying we have a candidate, we would like to run the feasibility with you because we know that when they run the feasibility with us, they test our platform, they see the benefit in timing, in automation and so on and they stay with us for the other phases on which I want to elaborate here Phase I and Phase II.

The biggest change we've seen in the past is the distribution between the geographies, back to 2022, we are 90% of the activity Oxford UK, the rest was in Bedford, Massachusetts with the acquisition [indiscernible] you see that today 20% of opportunities are in France between the two sides here or directly on our site in [indiscernible] and you see that's the U.S. also have a very significant presence now, I remember the time when we were discussing 90% of opportunities in Oxford 10% outside of Oxford.

Today is a very different picture 70% outside of Oxford, 30% in Oxford. One of my colleague recently asked a good question, which was doesn't mean that we have less opportunities for Oxford that the absolute value for the power plant for Oxford went down, absolutely not, because at the same time we were growing the pipeline value and the pipeline value has more than doubled in the past 3 years.

So in absolute value we still handled the same volume of opportunities for UK and we filled the other sides with new opportunities. If I look at the distribution over just one year of the pipeline dynamics it's very interesting to see that in Q2, 2025 we had 13% of the opportunities for the France sites, we still had 67% for UK and the rest was U.S. that for exclusively at that time.

If I move now 12 months later Q2, 2026, 19% in France, so obviously increased versus about a year ago, 46% in value here, not number of opportunities that we had on the previous slide. 46% of the value of the pipeline is in Oxford and the rest, very significant number, about 30% is for the U.S. site.

Why such a dynamic? For one reason, the acquisition of a commercial ready FDA-approved site in the U.S., which was needed, which was requested by our clients and which had a numerous impact. We have firstly this which in 2 days, keep those meeting, of a phase III project in Durham, North Carolina the process characterization will be done in Bedford Massachusetts the phase III batches, the process qualification of the manufacturing process will be done in Durham, the same client without the acquisition of Durham, we could not have executed in the U.S. So the acquisition of the U.S. sites completely changed the pipeline dynamic by sites. And if we look only at the first months of the year here. We build that site about 3 weeks ago, the number has changed now. But we have signed at that time 10 new clients, 4 coming from U.S. 5 from New York and 1 from Asia.

Actually we have 1 team in Asia today working with the client on the initiation of the program. Let's go back 3 years ago, I would have said 7 to 8 new clients in the U.S. 2 to 3 in New York that was the situation, with the 1 we started we really recognized as the global organization today, attracting some clients in Asia, we didn't even know that OXB was a severe one that time.

Attracting clients who understand that we run these 10 process characterization and validation and as we can do the same for them. And that's why we acquire clients at Phase III now, that has been placebo only, because of the expansion of the organization including the new vectors, including the new sites and including some recurrence revenue that you see here in the existing business, when one of our existing clients tells us, I would like a proposal for a potential new project 84% of these proposal give a contract.

That explains why we are very comfortable with our customer base, because usually when they tell us, we have a new program what do you think in more than 8 cases out of design with us. If we are at the negotiation stage, meaning it's not just a proposal on one-day that's the time line that's the budget, it's a real negotiation we signed 97% of these contract with the existing clients.

Moving to people who have not worked with us before, if we issue a proposal again 2 slides, 1 time line, 1 budget. We sign 1 program out of 3, at proposal's day. If we drafted the contact and we are not negotiating the terms, yet. If we drafted the contract meaning we have a scope of work, we're signing 2 out of 3, 72% exactly, but we sign 87% when we're at the negotiation stage.

I've worked for 3 different services business, that's the first time I see conversion right that high, that goes with the customer satisfaction that we enjoy, which on a scale between 1 and 10 is systematically above 8, if I take the average of the responses we have from our clients to whom we ask twice a year to feel the question here.

How did that change the situation actually we see it here, the number of pipeline is called development and early stage meaning called phase I, phase II activities has been pretty stable between April '24, May '26. And I'm going to focus actually on the difference between March and May '26 after. But number of early stage program pretty stable, between 40 and 45 roughly.

The biggest change that we've seen in the last 2 years is the increase in late stage program, we doubled the number of late stage program from 3 to 6. We added one more commercial programs and looking just the dynamic in the last year from 4 to 6 from 2 to 3 and in the last 3 months compared to 5-6 late-stage.

People come to us because they understand we are a CDMO, who can manufacture in 2 different geographies commercial products. So we can ensure dual sourcing, do we face tariffs, no because we can't manufacture in an U.S. Can we give you access to tax incentive in the op, yes because we can manufacturing in the Op. And so the Asian customers have been pretty happy with us making the manufacturing either in U.S. and New York.

I'm going to finish very quickly on that one. The pipeline is also divided between the different client segments where you see emerging biotech, established biotech. We would consider Cabaletta Bio as being an established biotech. And finally, you have the big pharmas here. It is as it should be. We want to support early-stage activity. We are not a CMO or a CDMO. And we want to continue innovating and developing for people who need support at early stage. That's why the emerging biotech segment will stay high.

I'm going to move now to the second section on which I will be quick because I believe that the discussion with Arun will be better than just going through the slides. But why do we see clients selecting OXB -- and first, how do people select CDMO. The selection criteria are more or less always the same. And as personally not seen any valuation in the past 5 years.

[indiscernible] is #1. How many times did you do it on time in full. How many times did you respond to the regulatory agencies. Successfully could you take a program at early stage and push it to late stage. Do you have the technical expertise and experience, which is slightly different from [indiscernible]. Do you have the slots, can you make it. Can you start, can you be fast enough. Can enumerate complex programs, it is very complex.

You need to design a vector, we are not working with just one vector, but multiples, LT, AAV, adeno, NDA. The list is quite long. We have this vector know-how. We have the manufacturing capability and capacity. We have the experience to support end-to-end. We can work hybrid capsules, where you need to create a new capsule.

We can work on the stable cell lines as we discuss. So that's very, very early in the development process, and we can bring these programs to the commercial stage. Last but not least, for me, that's one of the most important points here. We don't want to be seen as an organization that is only dealing with clients transactional relationship is the way I would call it. We're really the development and the manufacturing arm of the companies who come and work with us.

If you speak with our people running a project, they don't talk about the client project, they talk about their project. And we are also very impacted when we see that clinical data are not that good because many of our people, if not the vast majority, are motivated by giving access to new treatments to patients. So that's why we believe that each relationship can be a strategic partnership.

And I like the question, aren't you afraid to be exposed to emerging biotech funding issues and so on. But some of these emerging biotechs are called today Gilead, Sanofi, Novartis, BMS and so on, but they started as a very small company as well. So we are working today with the future BMS, Novartis and so on.

We -- why did they come to us. They come to us derisk the past 2 [indiscernible]. And I won't go through all the points, because these points have already been detailed by Nick in his presentation, we develop for GMP in the future. We want to show that the process harvest, they are validated and we are going to deliver a consistent result.

Then comes the quality and regulatory part. The documentation is ready we can manufacturing according to ICH, to the International Quality Standards, we're ready for any regulatory inspection, which means that we provide regular support to the client for the filing, and we are ready to be inspected by the agencies before inflation of the program on the market.

Not only we want to work with our client, but we want to retain them and I'm just said, since I joined the company, we've not lost one client who said I'm to leaving and going to another CDMO, why are the clients staying with us? We try to extract from different customer survey the main arguments that we heard coming from our clients.

The first one, successful tech transfer, we a feasibility some where else, can you take that in your lab and make sure that you optimize so that we have better process industry for early stage activity. Same comment for people coming to us saying we were working with a CDMO, that's made the phase I, they don't have the experience for Phase III and commercial can you do it, we did it successfully.

I took about the 12 months process guide, early. I'm not going to come back on that. But we have a very structured transfer and support. If we ask people what do you like most with our scientist responsiveness, so where is #1, you guys propose options. You provide solution. We come with a problem, you are extremely responsive and you try to find a way to unblock the situation. Once we've defined the process, we deliver in a reliable way. It's consistent, it's on-time execution, OTIF, as we call it, on time in full.

And last point, which gives me the opportunity to ask Arun to join me on stage, long-term trust. We want to be seen as partners. It goes beyond just delivering the development or just delivering one batch. We want to be seen as the commercial partner for the future of the program and of the treatments we're going to put on the market. Arun, if you don't mind joining me.

Since to was a long monolog, I'm going to pause for a minute and ask you if you don't mind giving a few words on yourself.

Yes, absolutely. Thank you, first of all, to you for the opportunity to have this chat to the Oxford team for inviting me here. It's a pleasure to be here. My name is Arun. I am Chief Business Officer at Cabaletta Bio, been with the company since its founding in 2019. My background started off as an investment banker, went to medical school, was a pediatrician at the Children's Hospital of Philadelphia and then came to Cabaletta in 2019. So I've been there for 7 years now and oversee our business development, enterprise strategy and new product planning efforts.

Cabaletta as a company, just a brief bit about Cabaletta was spun out of the University of Pennsylvania and formed for the sole purpose of developing and launching the first curative cell therapy for patients with autoimmune disease. We started off with a legacy platform and evolved into CD19-CAR T therapy about 4 or 5 years ago with the onset of the initial economic data and now have a program in registrational studies and several other clinical trials in development, evaluating our product candidate called Rese-cel, both with and without preconditioning. And so that's us as a company.

Thank you. I was actually not with the OXB when you selected OXB as a CDMO. And I joined at a time where the project was still considered as an early phase project. And I said why many of our clients choose us? I mean but I would be interested to know what are the important criteria that you list when you want to select, generally speaking, a service provider and more specifically, CDMO.

Yes, absolutely. So one of the things that I learned very early on at Cabaletta was the process is the product. And that line stuck with me in a way that few other things have in terms of being true and seeing it illustrated over 7 years of being at the company. And so by that, I mean, when you have every patient product needing to be manufactured in and of itself. You realize how important manufacturing is to the overall patient experience that's being delivered.

And so for us, when it comes to selecting strategic manufacturing partners, it really is, to your slide, not about a transaction. It's not about individual features. It's about the holistic opportunity to work longitudinally with that partner over time. And so I tend to break that up into kind of 3 things. One is technical expertise, which focuses on reliability, quality systems, on-time delivery, a lot of the things that Kyri and Nick mentioned in their presentations.

There's alignment on the strategic drivers of the field, what's going to move the field forward there, I think about scalability and innovation because what the business is today or what the business was a year ago, is probably not what it's going to be like next year, 3 years from now. And so we have to have a shared commitment to always look for how to optimize, always look for how to do better for patients to do better from a cost of goods perspective, a yield perspective, and that's something that if those 2 parties don't share a view on, it can be hard to operate. So that's certainly important.

And then finally, I would say cultural fit, which is you can spend weeks or months writing out a contract, negotiating it. And another thing that I've learned since I've been here is if you have to go back to that contract after you signed it, it's probably not a good thing. And so I can say the teams both at the leadership levels, the operating levels, every kind of function that I can think of, has the ability to reach out to their colleague on the other end with a call, with an e-mail and work collaboratively to help solve whatever the question or issue may be.

And I can also reflect a lot of the things that you summarized in the survey, which is the responsiveness of the team and the commitment to wanting to create a solution that maybe we hadn't even thought of to begin with is something that over the 7 years that we've been working together has really been noticed by the team.

You remember what was the most differentiating factor between OXB and the other CDMOs at that time when you made this selection?

Yes. So we've actually been working together. We're one of those repeat clients that you talked about because we've been working together since our legacy platform back in 2019, where we initiated some pilot work with the company. We worked on that together for 2 or 3 years. And then when we pivoted to Rese-cel, our CD19 program, continued working with Oxford at the original 2019-2020 decision, the primary driver was reliability, ability to technically execute and the fact that you all were really the only ones that had done it before.

As we -- that was, I would say, sort of the initial frame in addition to the same strategic alignment on views and the cultural fit that we had noticed the years that we spent working together just reinforce those principles. And so by the time that we had Rese-cel and we had a decision internally to make around who do we want to work with. At that point, it really wasn't a question. It was we've had such a positive experience working with the team over time.

And one other thing I'd say is that the longevity of the folks that are at the company and the low turnover rate is a really important feature of working with folks because it reflects what happens at Cabaletta, too. There are folks at the company and majority of folks that are the only people who have ever held their position at the company. At Oxford, we see a similar feature of low turnover consistency and interaction when you know the people that you're working with on the other side, it really becomes an easy decision.

So much is here. And actually, I must say you're absolutely right. Since I joined the company, I have worked at Cabaletta with the same team.

Yes, that's exactly right. We like to say there's a picture on our website. where I think 8 of the 10 people or 8 of the 11 people, of all many people are up there are the first people to ever hold the role at the company and the only people to ever hold the role at the company in the history of the company. And so I think that is unique in biotech and something here in this case that I think is quite unique to Oxford as well, which is the continuity and longevity of the team that's there.

The world has changed between 2020 and today. Have your selection criteria at least change as well? Or would you make the same selection with the same criteria?

I think, the question on selection, yes, we would make -- I think the outcome wouldn't have changed. I do think there's been some evolution in the criteria, not in terms of adding in the leading, but more in modulating the emphasis on some of the criteria. So for us as we've transitioned from, as you described, early stage -- early clinical stage to late clinical stage. And as we've seen Rese-cel grow and demonstrate clinical data, the opportunity for patients to really benefit in a significant way what we've realized is that the importance of scalability, industrialization, I really like Luk's word and sort of the phrase he used, industrialization of the manufacturing process is increasing in importance because what we realize is if we truly are able to execute on innovation, we can open up the opportunity for maybe an order of magnitude more patients to be able to receive CAR-T therapy, in our case. Well, then we're going to have to be able to make enough product for those patients to be able to access it.

And in order to do that, we need partners who can reliably deliver, reliably deliver at scale and reliably deliver at scale at a cost that is -- provides the opportunity to be able to give the drug to patients at that scale. And so I would say there's more been an emphasis in those criteria, not really a change in what the outcome would be, but in how we think about really optimizing the opportunity for folks.

Understood -- on one of my slides, the outsourcing rate, which is increasing. You made the decision at Cabaletta -- some of the activities is running. When exactly did you make that decision in the development process? And why did you decide to go outside instead of building the capabilities internally?

Yes, it is a very, very insightful question because I would say, in the early years of the company. So for the first 2 or 3 years that we were in existence, this was a never-ending discussion. And by that, I mean, at the time, so this is now 6, 7 years ago, there had not been a cell therapy company that had been able to achieve success without having its own manufacturing facilities, both vector and cell processing.

We had many, many discussions and opportunities around should we invest in our own bricks and mortar should we continue working with CDMOs. Again, at the time, the ability for -- and the commercial experience of CDMOs, including Oxford is much less than what it is today.

So this was a discussion that, again, was really ongoing all the time. What we eventually made the decision of realizing are now, I think, grateful that we did was that we, as a biotech company, have limited resources, limited people and a need to allocate capital and people time to the activities that we do best. And the things that we believe we do best are clinical development, commercialization of therapies, discovery of new therapies. And if we can find trusted partners that are able to take on and partner on certain core attributes, core capabilities that we need for the product. that's a good investment of our time and capital.

And the other thing I will say is that just purely from a capital perspective, when you put in bricks and mortar into the ground, the amount of money that, that takes for an emerging biotech that's in development stage can often be prohibitive. And then you also get to the question of -- and I think you had this in your slides as well, capacity, which is you're building a facility that you hope at peak capacity may be able to support thousands of patients a year. But when you start off as a company with a product, you're unlikely to be at whatever that peak capacity is. So for the years that you're building up to that capacity, that excess capacity is just coming down into your bottom line, it becomes hard to operate for us, making the decision to partner with CDMOs from the get-go has eliminated a lot of those fixed costs, eliminated a lot of those carrying costs. And we're grateful not only for the benefits from a financial perspective, but because it really allows us to focus our energy on the places where we can deliver the most benefit overall.

It was a very interesting question earlier about evolution of the patient population -- design concern. And for me, there is a link to how you build and how you work on making sure you have the right commercialization strategy. Without entering into confidential information, can you tell us how you're building the commercialization strategy for what will be soon your first product?

Here, I think there is a foundational assumption because CAR-T has been a commercial entity now for nearly a decade. And I think we have made real efforts to try to delineate between CAR-T commercialization in oncology versus CAR-T commercialization and autoimmunity. And for us as an autoimmune company, CAR-T commercialization and autoimmunity is going to look very different.

The biggest reason why, in our view, is simply the number of patients that can be served with the therapy at hand and the benefits that the therapy is delivering both from a safety and clinical activity perspective are really promising and sort of point towards a scale of patients that can be provided this therapy in a way that's just fundamentally different from what we see in oncology.

So I say all of that because it absolutely has affected how we think about commercialization and what we emphasize. So the things that we are emphasizing are being able to -- and I know these words keep coming up, but being able to make enough products for patients, so scalability, being able to do so in a way that makes the therapy not cost prohibitive because if you're treating tens of thousands of patients a year, not hundreds or a few thousands of patients a year, you get a very different sort of economic return, economic look and you need a different profile in terms of what the product is that you're making.

And so it's about innovation from being able to deliver a drug that can be suitable for enough patients and then being able to make enough of that drug to be able to give it to patients if and when they need it. So that's really been at the forefront of our commercialization strategy. And again, being able to do that with folks who understand it, who share the view of the importance of what that can mean and then who work with us to help accomplish it are how we are successful.

I'm going to look at time already to -- if we have time for one very last question -- how important was it back in 2020? And how important would it be today to select a player that is by default a global player?

Yes. Understood. I think it would be naive to think anyone in this space can be successful by focusing solely on one country. and that how each individual company's commercialization plays out on a global scale to be determined, but I think everyone believes it is to your benefit to have a presence in multiple geographies to advance regulatory clinical efforts in multiple geographies and then to be able to have the opportunity to commercialize globally. And because of that, basically manufacturing capabilities to enable that is almost like the ticket to play. It's table stakes.

And so we need -- I decide we need we require any CDMO to be able to manufacture across geographies because if we're restricted in 1 area, restricted to 1 area, then you essentially have to double the work that you're doing simply to expand the geography. And that's really, again, not an efficient use of capital, not an efficient use of time and forces us to take time away from, again, the things that we feel like we do best.

And so when we can work with partners who have that capability already checked off, we've already gone through the process with EMA, gone through the process with the MHRA, gone through the process with the FDA then those are things -- it's not that we don't have to worry about it because we absolutely would worry about it. But it's we know we're working with someone who's been through it before and can give us experienced guidance and advice along the way while we're working together to advance it in whatever geography we're looking at.

Very clear. On time.

Wonderful.

Thanks very much for coming. I know that Philadelphia is not really next door. So thanks very much for making the trip and coming to us.

It was a pleasure. Thank you.

Thank you, Arun, for your perspective, and thank you, Sebastien. I hope you found the discussion insightful. What clearly emerges is that track record and experience are critical when selecting a CDMO as well as global scalable manufacturing, quality, commitment to innovation and an open, trusted relationship.

Now hold on to your questions. There's a Q&A session right after our final presentation. And I'm now handing over to Lucy Crabtree, our Chief Financial Officer, for the next session.

Thank you very much, Aurelie. So I'm delighted to be here today to talk you through our financial strategy for the coming years. And how we will deliver growth and of course, importantly, shareholder value with our long-term plan.

So first, I'd like to start by looking back at our performance since our strategic refocus as a pure-play CDMO. We have delivered significant financial momentum over the last 3 years with strong execution, commercial momentum and disciplined cost control translating into strong growth in revenues and profitability.

On top line, we have delivered revenue growth of almost 90% since 2023, representing a 2 to 3 -- sorry, a 2-year CAGR of circa 37%. Significantly, we've also achieved positive operating EBITDA profitability for 2025 and a milestone that demonstrates that we're not just growing at the top line, but we're becoming a profitable business and have made rapid progress from our operating EBITDA position in 2023 when we made a GBP 53 million operating EBITDA loss.

This strong financial growth was delivered during a period of significant business transformation. I don't think that should be underestimated. Not only did we deliver successfully an operating model reset within a volatile macro environment. We also expanded globally with the expansion into the EU with our Lyon and Strasbourg sites, and we, of course, more recently increased our capacity in the U.S. with the acquisition of our Durham facility.

So I'll not spend a lot of time talking about our prior performance as I believe that the most important takeaway here is that we now have a strong foundation and with the building blocks in place to continue growing further, capitalizing on the rapidly expanding cell and gene therapy market.

So as you will have heard from the presentations earlier today, we're incredibly excited about the potential of the cell and gene therapy market, and in particular, OXB's competitive positioning as a viral vector CDMO. The viral vector CDMO market is expected to grow at a CAGR of around 18% through to 2030. We are highly confident that we will continue to outperform the market growth rate over the long term. And our ambition is a revenue CAGR of approximately 25% from 2025 through to 2030.

Several key factors are driving our confidence in achieving this, which Sebastien spoke about earlier, and I'll touch on briefly here. Firstly, we're seeing a growing maturity in our client programs. In 2025, over 60% of our business came from late-stage projects. This is critical because late-stage work brings a high level of predictability and revenue visibility. It's more stable and provides better line of sight into our future performance.

Secondly, our U.S. facilities provide significant potential for revenue growth. In 2025, we more than doubled our U.S. footprint with the acquisition of Durham facility, giving us the capacity and capability to serve our clients' most advanced programs. We have the suites in place to service our expected growth. And with our flexible gray zone space in the U.S. We can quickly add additional suites to scale up as needed and capture the growth opportunity ahead of us.

Thirdly, as Sebastien explained earlier, we also maintained exceptionally higher client satisfaction. This isn't just about retaining existing business, though we do see high levels of repeat demand from current clients. It's also about our ability to win new business. With the majority of our recent wins coming from the U.S. and Europe, as you have seen, which, of course, are the largest cell and gene therapy markets.

Finally, we have great confidence in our platforms, which are supported by cutting-edge technologies and our 30-year track record, which Kyri and Nick spoke about earlier.

So next, I want to talk to you about our longer-term revenue vision. With a revenue CAGR of approximately 25% from 2025 through to 2030, our ambition is to achieve revenues of approximately GBP 500 million in 2030. We don't see this as overly aspirational. As the business matures, we see this as a realistic outcome supported by our track record, underlying market growth and the capacity already in place.

So on this slide, I'd like to give you an illustration of how this could potentially be achieved and we have split this into multiple components. Firstly, process development revenues. In our illustration, we could assume this broadly tracks underlying market growth with CAGR of around 18%. We currently support around 40 early-stage projects and have a circa 30% proposal win rate, giving us confidence in securing new business. This first component would be estimated at contributing approximately GBP 150 million of revenues annually by 2030.

Next, pipeline maturation potentially contributes GBP 150 million of revenue by 2030 as programs progress through the funnel and revenue per program increases. This illustration assumes around 40 early-stage programs, approximately 50% attrition and standard batch volumes and pricing.

Lastly, the primary swing factor is commercial scale-up. Just 2 to 3 mature commercial programs each serving around 1,000 to 3,000 patients can potentially generate roughly GBP 200 million in annual revenue, representing the majority of the revenue buildup in this illustration. This is consistent with a bottom-up view even at moderate patient populations, GMP manufacturing economics scale quickly.

Importantly, there are already multiple CAR-T programs either approved or in development for hematological oncology and autoimmune indications, which you've heard, relevant for the 3,000 to 5,000 patient range. With 9 OXB client programs already in late-stage development or under commercial contract, reaching 2 to 3 scaled programs is a credible near to midterm outcome.

So overall, this illustrative revenue build is deliberately conservative. It assumes standard pricing, modest batch volumes and significant attrition across the early-stage pipeline, leaving potential upside from stronger conversion, improved pricing or dose expansion. Critically, the existing manufacturing footprint already supports this growth with no requirement for additional new build CapEx.

As we move from our 2030 revenue ambition, I want to turn to how we expect to drive further margin expansion. Our long-term operating EBITDA margin target of approaching approximately 30% is consistent with other mature CDMOs. And here, I'll talk to you about how we expect to get there. We've already made strong progress.

In 2025, we delivered our first year of EBITDA profitability since the strategic turnaround or strategic refocus. Driven by disciplined cost control, and improving operational execution. At a higher level, margin expansion is expected to be driven by a small number of dominant factors.

Firstly, you have the mix shift to later stage in commercial work as the single biggest contributor, worth up to around 1,000 basis points, improving volumes, pricing and unit economics and driving a corresponding reduction in cost of sales as a percentage of revenue.

Next, installed capacity supports a utilization ramp of a similar magnitude, converting our largely fixed manufacturing cost base into operating leverage as activity scales across sites, particularly as new capacity ramps.

On admin expenses, the corporate platform benefits from operational leverage, costs growing materially slower than the top line, contributing up to around 700 basis points as revenue scales. For commercial costs, sales efficiency improves with higher productivity and a structurally lower cost per win as we move up the experience curve.

This allows commercial investments to stay broadly stable as a percentage of revenues. We will continue to invest in innovation. You've heard how important that is to protect and build our market position. As Kyri spoke about earlier, innovation plays a pivotal role in our success and enables us to provide best-in-class services to our clients. We would expect for spend to stay broadly stable and gated to returns. This brings EBITDA margin approaching approximately 30% by around 2030 to 2031. In terms of cash generation, we would expect to convert a substantial proportion of EBITDA into free cash flow at maturity.

Looking at our next slide, this shows that the pathway to this long-term margin guidance is not theoretical. It is a well-trodden CDMO maturity curve, and we're already on it. While cell and gene therapy is a new modality, mature CDMOs across monoclonal antibodies, ADC and CGT markets achieved margins above 30% at utilization maturity. This is a proven industry pattern, not a stretch target.

Importantly, we are still -- we're already seeing that operating leverage comes through. In 2025, incremental revenue flow-through exceeded around 30%, and demonstrating strong margin progression even with our current utilization levels. Today, the business overall is still in the scaling phase, ramping utilization and just beginning to see that margin inflection. However, our U.K. site is obviously more advanced providing clear validation of our model at scale, while other sites are earlier in the curve, but positioned to accelerate as utilization increases.

Looking ahead, the network is now scaling meaningfully. Durham comes online in the second half of 2026, driving U.S. utilization. And France is roughly 3x its installed capacity headroom at high incremental margin. enabling a true multisite model. Under new commercial agreements, we have the ability to manufacture both in Durham and in the U.K. will facilitate further margin expansion by accelerating U.S. capacity utilization.

Finally, AAV and lentivirus tech transfer completion in France alongside a shift towards commercial GMP mix and procurement scale supports our 2027 expectation of at least 20% EBITDA margin firmly on the path to approaching 30% in 2030 to 2031.

Now moving on to CapEx. The delivery of our long-term expansion of the business is underpinned by a comprehensive capital allocation program aligned to strategic priorities and required returns. We have outlined a defined GBP 70 million to GBP 75 million CapEx envelope, across 2026 to 2028 as a disciplined investment cycle with a circa GBP 50 million CapEx across 2026 and 2027, followed by GBP 20 million to GBP 25 million steady state CapEx in 2028.

Investment is focused on scaling our U.S. GMP manufacturing capabilities, including the commercial activation of our derm site to meet client demand. We also intend to further strengthen our global CDMO network through flexible tech transfer across the U.K., U.S. and Europe, enabling resilient multifactor delivery for programs from development through to commercial supply.

Kyri and Nick mentioned earlier, some of the ways that we're already using automation and AI in the business, and these will be further embedded across our operations to enhance capacity, planning, tech transfer efficiency and process performance. And as mentioned earlier, we will continue to invest in innovation and platform productivity, including process intensification, analytics and yield improvement to support improved cost of goods as the business scales. We will maintain our financial strength and flexibility by keeping our balance sheet capacity intact, ensuring the business is fully capitalized to execute our strategy while retaining the ability to support further strategic options.

So in summary, I believe we've set out a clear achievable path to value creation. Our transformation into a pure-play CDMO is on the verge of being complete and our commercial momentum is now driving growth in revenue and profitability. We're confident in achieving revenue growth that outpaces the broader viral vector CDMO market, underpinned by long-term client relationships and maturing programs.

As mentioned earlier, we see a realistic path to revenues of circa GBP 500 million in 2030. As site utilization increase over the coming years, we expect to achieve operating leverage which, coupled with continued cost discipline, will drive sustainable EBITDA margin expansion approaching around 30% by 2030 or 2031, as we become a more mature CDO. We have a customer-focused growth model that is structurally accretive to working capital and a path to robust cash conversion as the business matures.

We will continue to execute our disciplined capital allocation path prioritizing investments in growth while retaining an attractive EBITDA profile. So I'm incredibly excited about the future ahead as we move into our next phase of growth and continue to deliver as a leading global viral vector CDMO. So thank you.

And with that, I think we're ready for Q&A. So I'll hand over to Aurelie.

Thank you, Lucy, and thank you to all of our speakers. It is definitely a very incredible time for OXB. We now have a second Q&A, and I'll invite Frank, Lucy and Sebastien. And we'll start with questions from the room and then move to the webcast question.

Charles Weston from RBC again. One for Arun first, if I can, please. So thank you for the color that you provided. Can you give us a sense of how much viral vector is as a proportion of your COGS basically at maturity when you've actually got products out there and patients being treated? And secondly, what would make you think about dual sourcing your viral vector supply?

And my second question, please, for Sebastien, who's just handed the microphone over. Just on that pipeline chart that you provided, I think you said around about 1/3 of your opportunities by number were Phase III and commercial, which means presumably, given they're 5 to 10x the revenue, a massive proportion of your pipeline by revenue is that? I mean is my math right?

Okay. Do you want to start on?

Yes, you want to...

Not that.

Okay. So I guess -- so a multipart question, let's see if I can get it all. First part is what portion of our COGS are driven by viral vector. We have not publicly disclosed our overall COGS and what exact portion it is.

What we have communicated publicly previously is when you think about the early launches of CAR-T, a lot -- a significant portion of the cost was, in fact, viral vector or the year. What has happened is that because of improvements in scale and tighter in yield we have seen the cost per patient and Sebastien's metric is really the important one to think about that he referenced in either the first Q&A or in his presentation, the cost per patient is what we are focused on. And the cost per patient that is attributed to vector over the years as CAR-T has matured, has gone down precipitously.

So it is not a significant driver in the overall cost of goods when we think about delivering a product to patients that is in all aspects of what we would want to make. So that cost has gone down significantly, which is really great. there are costs, and these would be modeled in sort of any way you think about it in terms of process development, process characterization that we have to work on together. So that's an independent aspect of it, but I just wanted to make sure we were clear there.

Now I missed the second part. I missed the second question. What was the second?

It was scale or what would make you think about dual sourcing?

As in internalizing it?

Well, either.

I think it really goes back to the criteria that we talked about. So it's -- when we think about, I think, as a company, who we are and what we want to be, we're always thinking about risk-adjusted value. So whatever choice we make, we have to make sure that it provides us the highest value on a risk-adjusted basis that we have.

The reliability and the experience that the Oxford team has makes that risk-adjusted value number go up because of the experience that's there because of the reliability that they have and the experience with the agencies. So unless there was some significant change in that equation, it would be, I think, not a likely scenario. Now, no one ever knows what's going to happen, but I think that's at least hopefully helps you illustrate how we think about it.

And then for the second question, I can hand over to Sebastien.

30% of the pipeline in a number of opportunities is between Phase III and commercial, indeed, so not in value, number of opportunities. The portfolio of late-stage activities is extremely diverse. You can find the process characterization, small-scale activities in Nick's lab. You can find the repeat manufacturing. Process characterization process can be 5 million, but 10 batches are going to be, let's say, 20 million for the sake of the exercise.

So the number of opportunities will not tell you much except that indeed, the value of late-stage opportunity is way above the value of an early-stage opportunity. Why are we there compared to a few years ago because of the combination of today a number of programs that we were running in Oxford that reached at that stage, late-stage preparation for commercial activities or even building inventory or future commercial introduction, plus acquisition directly of new commercial programs, acquisition of the site in Durham where we have attracted new clients. I talked about one where we have the kickoff this week on a new late-stage program.

Indeed, it's a very significant portion of the pipeline. And if you look at the number of projects, it's more or less 20% of the projects that we run today. One project can be 2 different opportunities because there may be one part of the project in U.K., one part in the U.S., which that has 2 different opportunities and could be 2 different type of activities, could be process characterization and routine manufacturing some clients as to have 2 different proposals for these activities and not just one for multiple reasons.

Indeed, it's a very big part of the pipeline, to my surprise, I must say. I did not expect that. And I believe it's part of OXB team efforts that are paying today as the head of marketing. They did a very good job at rebranding Oxford Biomedica, OXB, that's making sure that we were recognized as CDMO as a global CDMO and the perception from the market on OXB has really completely changed. So indeed, it's a big part of the pipeline today.

James Orsborne from Stifel. First question, just around following up on those late-stage projects. We know obviously our select have filed their BLA and probably going have the fed at the end of the year and then have some positive data and like you might launch next year. Just wondering how you, as a CDMO approach that are you manufacturing a risk? Or how do you structure that from your side as they move into the launch process?

Well, manufacturing at risk is not really how we start the discussion with our clients. I mean, that wouldn't make a lot of sense to manufacture at risk actually. You know what you need for the clinical studies. Based on the clinical data through Phase III, you know exactly how you're going to work on your market introduction.

Based on your market introduction strategy, how many batches you need. So the risk is actually very limited, except finding, and I don't see how that would happen. But except finding in the middle of Phase III that finally, you have a safety issue. I mean, that would be very late, who knows, but there is not much risk. At this stage of the relationship with clients, they have a forecast that they communicate.

It's binding because they need slots and they need material at a given date. We commit to delivery date and we manufacture according to their forecast. So it's very scripted, very guided. They know where they go. They know exactly where they want us to go. We go in this direction.

And maybe one for Lucy on utilization. And obviously, that's going to be a key driver to margins. Where are your peers at and deep utilization? I am -- saying up there in the top right versus where you are today, if you can help us with that at all?

I think it's a slightly different -- difficult question to answer because, obviously, the different seating as take different shapes. I mean, really, that slide is just designed to show indicatively we can see what this path is. Now we've got our own journey to take as a pure-play viral vector CDMO. And we know internally what we're striving for in terms of peak utilization. We've got very good utilization levels in Oxford. And obviously, as Durham and our other facilities get to sort of peak capacity, those utilizations will look exactly as we are sort of guiding towards and working towards. And that's really what drives that margin expansion. And we have mapped this out. We have a long-range plan, where we're looking at this very, very carefully.

Sam England from Berenberg. Just one around CapEx plans. Can you talk about how much of the GBP 500 million revenue ambition can be fulfilled with the existing capacity you've got plus Durham capacity coming online this year. Or are you assuming further I think call gray site additions from 2027 onwards. And how should we think about CapEx needs beyond 2028 as the business continues to scale both in sort of value terms, but also geographically, where you might look to add sites?

Yes. So look, we have -- we've mapped out our CapEx requirements, and we've got enough capacity to fulfill the GBP 500 million ambition, albeit our CapEx requirements, particularly in sort of '28 and '29, incorporate, expanding into the gray zones, right? So we don't need to break new ground or build new sites. That's the most important thing. And what we've steered to is obviously the circa GBP 50 million over '26, '27 and then steady state thereafter. And that obviously captures how we need to sort of service and expand into those gray zones.

Miles Dixon again from Peel Hunt. If I can just check on my understanding and the risk to the upside on the GBP 500 million. Sebastien, I was surprised to see, I believe you said GBP 10 million to GBP 150 million for commercial stage projects and that you currently got 3. Lucy, I thought you said 3 commercial stage projects in 2030, we might expect to see GBP 200 million. Given the retention of those late-stage clients that you've got is 90%, might we expect to see 6 to 8 commercial clients by 2030?

So a great question. And I think as you can see, plastered all over that slide is illustrative, right? What we're trying to sort of give is we have mapped out our GBP 500 million revenue ambition. It's a target. It's an aspiration. And it's an ambition. And we've looked at different ways of sort of cutting the level or whatever the expression is to -- we look bottoms up, we look top down. And this really is going to be ingested. And as I said in my narrative, this is perfectly achievable in our view, okay?

Now, of course, there's upside. This isn't a cap. It's a milestone that we're looking to achieve. So this isn't me steering in saying, look, we expect 2 to 3 commercial programs. This is saying, there is an incredible rationale for how we can get to that aspiration in 2030, but I don't know if my colleagues want add anything.

If I look at how we built the long-range plan, which is giving the circa GBP 500 million that was on the slide. A commercial program can reach GBP 150 million, but then we're going to go back to one of the previous questions, what about fourth line of treatment, third-line treatment and so on. When you start a new introducer are going to treat the first year, I remember seeing a plan from one of our clients recently, was planning the first year to treat a few tens of clients to go to a few hundred you needed 3 years to go to a few thousand, you need another 2 years. 2031 is in 5 years from now.

Then it grows exponentially because the success you had in Europe or U.S. you're finding then in Korea, Japan, Middle East and so on, and that's where the number of patients keeps increasing. What we should never underestimate is the time to move the program from fourth-line to third and even second-line or filed with other geographies. The timing that we discussed with our clients when we talk about manufacturing, we took in quarters.

When you look at the filing time line, you're talking years. You can submit in Japan today. You won't get a response or you won't get a program approved even next year, probably be the year after. Then you will start treating the first patient commercially and to go to a few hundreds will take another 3 years.

So that's the reason why even if we see from what we're doing today, Arcellx was mentioned earlier, good data with Kyverna, good data with Cabaletta and so on. We know that all these programs are going to be commercial quite soon, but we don't underestimate the market introduction time line.

So we see a bright future beyond 2030, but compared to biologic cell and gene therapy is still a nascent market. And before we see the same number of patients treated with gene therapy treatment compared to biologics, there will be a few decades.

Unfortunately. Maybe we'll shorten it a little bit.

Yes. Chris Glennie with Stifel. Just trying to -- you talked a lot about quite a lot of excitement around in vivo CAR-T, particularly and versus the ex vivo currently sort of most of the products today. Does that change in terms of what sort of you have your sort of expertise, your technology that you need to offer to be able to meet that interest and obviously, we've seen a lot of acquisitions in this area, particularly as well. So is there anything that you need to adapt around that sort of inversus ex vivo?

We don't need to add up the team has experience in vivo, Oxford Biomedica as a company developing its own products in the past was on in vivo therapies as well. So we don't need to adapt anything. In the discussion we have with the executive team, I'm probably less excited by in vivo because of the time line. If you look at the slides we presented today, 112 in vivo programs. 2,100 ex vivo programs. In vivo will come for sure, but we still have 20x less in vivo programs than ex vivo. So I believe that the next 5 years are going to be still very intense with ex vivo. There were indeed acquisitions as it could be expected.

Many big pharma continue to not develop and on board through the acquisition of emerging biotech, Same trend as always, I am tempted to say, 20x less. So in 5 years from now, I think I will have very good reasons to be excited by the commercial pipeline in vivo. Today, we're engaged in multiple discussions with the in vivo companies. But as Kyri showed it, a number of Phase I is, yes, a handful more or less, it's the very beginning.

So yes, it's exciting. But with a 10-year horizon, ex vivo is now.

And then a follow-up, just a little bit unclear where you are with the nonviral offering opportunity. On the one hand, you said something you're working with today, but then I think Frank said that's not in the near term. you're the viral experts, right? So what -- so what are you offering today? And what might you need? Do you going to acquire something? Or what's the strategy around nonviral, just trying to really understand. I get the whole more holistic offering across all your -- everything you can do, what would you actually need to be able to be a credible nonviral part?

That's a very good question. Let me start to make it very clear. I would say, for the next 3 to 5 years, our focus will be on viral vector. That's where our expertise is. It's where our differentiation against competitors is that's what we will do. Now we have also to think ahead of these 5 years. And then we look at what could be within the field of cell and gene term because without leaving this field, we might enter nonviral.

Honestly, I believe the only way to do it would be by an acquisition so far, I cannot see another way to do it, yes. Now there is something in between, which is called virus light particles, yes. And we will enter this field in the next -- or we are about to enter this field. And this will be the first step to enlarge a little bit just not only doing by vector. But I don't see nonviral before 5 to 10 years.

We're building the strategy to make sure that we're not missing the train of the nonviral vectors. You've seen it on one of my graphs, the space in which we place about 50% of the gene therapy program, we know that nonviral will continue to evolve, we'll continue to take some market share. So we will be ready on time.

We also don't want to echo what Frank just said to reinvent the wheel. There are people who do that fantastically well. It will be a good opportunity for us to grow by acquisition. Exactly what we've done with AAV. We acquired the CMC team of a company that had built an expertise and experience the full platform on the AAV side. And that's the reason why today, our AAV offering works.

If we had started AAV from scratch, we would probably not have a platform yet today. Same for the nonviral space. So we're working with the strategy team on the potential acquisition strategy for the future. It's a long-term exercise. Indeed, if we were moving in 3 years from now, I would consider it's an early move already. We look into it. We're not close from pulling the trigger at all.

Julie Simmonds, Panmure Liberum. You've made a really good case as to why Oxford Biomedica due to the sort of longevity of the knowledge and the experience you've got. When you don't win clients, who do they go to and why?

I wish I know, but many times, the clients do not want to communicate with which CDMO they're working. I'm actually glad that our own and Cabaletta by overall accepted that we communicate on the relationship. But if you look at the numbers of logos that we display on our slides versus the number of clients, I mean, like 10%, 20% of our clients max, say it. So we don't know, but we know the usual suspect. There are going to be Lonza, Catalent and AGC Biologics. We usually lose for the very big ones because back to Charles' questions on the weight in the pipeline of the late-stage opportunities. Many companies now have understood that working with the CDMO just for Phase I and then finding a reliable partner for Phase III is not a smart move.

Pick the right partner from the very beginning and the right partner need to have the capacity, the capabilities and the experience and from the 160 CDMOs in cell and gene therapy worldwide. If you select only those who have the commercial experience and the commercial track record, then you're going down to 10-ish, not more than that. So we know that usually, we lose to the big ones. Yes, the 3 names I would mention are the one I mentioned already, but many times, we don't know.

And in terms of sort of the Durham site, has that generated more interest globally from new partners? Or is it mostly those who are wanting U.S. active.

U.S., clearly. The European clients are still very interested by Oxford, Lyon and Strasbourg. So it's -- the demand is primarily coming from U.S.

I would say we have time for 1 or 2 questions from the room.

It's Kane Slutzkin, Deutsche. I don't want to take away the theme of the long term, but if I could just quickly sneak one in on near term. You're probably going to shoot me down. But any commentary on sort of current trading, given we're sort of 5 months into the year? Is it still the H1 sort of loss into the H2 swing for the full year this year?

Yes, sure. So I mean, look, I think the Capital Markets Day were here to sort of talk about the long term. We obviously spoke about current guidance at the full year result. And I mean, it remains the same. We're not changing any of our guidance. And yes, it will be second half weighted.

So that was the last question -- but I saw him raising his hand many times. He never comes.

Thanks a lot. So the slide showed significant late-stage opportunities in your pipeline. Can we assume, therefore, that -- there are many of your projects, your early-stage projects, programs that you're in your competitors' late-stage pipeline? And do you have visibility over that?

The late-stage opportunities are coming either from programs that have demonstrated safety and efficacy in Phase I. It's one of the beauties of gene therapy. You can see the efficacy as early as Phase I but also from the people coming to us, I mean, as I just said, we had a CDMO for Phase I. They can't do Phase III and so on. So that's really a mix. We see that we've -- I don't believe we became more attractive, we just became more visible. And for that reason, we see more people coming to us saying, why don't you take that on top, and that's the third layer, which we should not underestimate. People will say, we need a lot of capacity, and we're working with the CDMO. They have limited capacity.

Would you be a second supplier? So it's not a question of dual sourcing in the sense of business mitigation 3D capacity play. And we've built capacity at the same time as we build expertise. So that's really a mix of these 3 that we see today.

So as early-stage program is showing promising data. Presumably, you are in deep discussions with those clients on getting them into your late-stage programs.

Well, actually, many of them from the very beginning, and it's probably because of our approach as well. we tend to sign with our clients master services agreements that cover all the phases so that we don't need to renegotiate afterwards. I mean, in full transparency, I have a call with one of our very new clients. We just started a feasibility study a couple of weeks ago, 3 weeks ago there. And they want to incorporate into the master services agreement, the prices at commercial scale.

Ultrarare disease, fast-track designation, they want to know what commercial is going to be like. So meaning that commercially is part of the early-stage contract as well. Not unusual, not the first time I see it. You wouldn't see that with small molecules or biologics, you see it in gene therapy. And for that reason, we know that we can bet on late stage coming from early stage.

Yes. That's very helpful, if I could slip in one more. Clearly...

Ask the boss.

Yes, it's a quick one, I think. Clearly, the acquisitions of Lyon and Durham have been transformational to your positioning. Are there other stranded assets out there that competitors could acquire that could, therefore, transform their businesses?

Very good question. You've seen recently a lot of companies divesting their CGT business. They have the capacity, they did not have the expertise because we had the expertise and the demand we acquire capacity. It's a very different thought process. Many of our competitors today, including some names I mentioned earlier, are struggling because of the turnover of the employees.

I didn't say it, Arun said it. The tenure at OXB is exceptional. Kyri, 25 years. You're soon approved 12 years with Nick. We built an expertise that attracted a number of companies to us. For that reason, we need more capacity. We acquired that capacity that was Lyon. When we acquired Lyon, we acquired Lyon for 2 reasons. We needed commercial capacity in the U.S. And the site was not coming as an empty shell because we have proposals for many empty shells. And we systematically said, no, we're not going to bid. We acquired Lyon because it was a building coming with experience and a very experienced team ex Bluebird Bio employees, who had stayed with resilience, who stayed with Oxford Biomedica.

Out of all the employees who were on site, we lost one at the time of closing. So it was really about making sure we were keeping the expertise. It was the same with Lyon and Strasbourg. Strasbourg site was DMP for viral vectors in 1995, 31 years ago. Empty shells not interested, effective teams, absolutely. There are not so many effective teams on the market.

More questions? We'll move to webcast audience then. A question for you, Sebastien, from Harry Gillis from Berenberg, our later-stage programs with higher volume, more profitable on a per patient per dose basis, due to economy of scale as well as having larger contract size. And thus, OXB's manufacturing capability per unit of manufacturing footprint increase if there is a mix to fewer, larger late-stage programs.

More profitable. Second one was...

More profitable on the payer patient dose basis due to economy of scale as well as having larger sets...

Yes, and bigger size of the contract, right? Not always to the second part. It's not always a bigger contract. I have in mind one of our clients, ultra-rare disease, the need is one batch every year, maximum at commercial scale, maybe one batch in 2 years.

Some very early-stage programs, we need 2, 3 batches. So you cannot always say because it's late stage, it's going to be a bigger contract, not sure, particularly in gene therapy. If you look average to average, indeed, the average late stage is much bigger than the average early stage. That's very clear.

Economy of scale is a very good question, and the answer is absolutely not straightforward. If you make the decision, Cabaletta made the decision actually very early in the process to look at efficiency, automation in the cell manufacturing process, for example. Then you are going to look at the cost of goods from the very beginning of your process development, exactly what it is. Then you're going to benefit economies of scale. At the beginning, you know you're going to start at 200 liter, you're going to get x doses, you're going to automate the cell manufacturing process. But it needs to be by design in your process development and manufacturing plant. If you don't plan for that, you won't see any economy of scale. It's always very surprising, but I still see many people and let's say, 90% of the discussions we have.

When we say if you were scaling up from 200 liters to 1,000 liter, you would mathematically divide the cost per dose by a factor of 2 to 3 and people say, I'm going to stay at 200 liters. So to benefit from the economy of scales, you need to proactively make that decision. It needs to be part of your development plan, and that's not always the case.

Is that more profitable? By definition, running routinely manufacturing is more profitable than working on the process development project. Let's go back to a couple of numbers. How many -- if you take 100 programs at process development stage leading into a Phase I, how many will fade in Phase I, 9 out of 10.

So indeed, the level of risk being very high. These programs are by design, less profitable than routine manufacturing, where the success rate in manufacturing is 95 as percent.

And another question from Chris Richardson from Jefferies. The Cellares Cell Shuttle take makes a strong case for enabling scale in larger indications from Cabaletta's perspective .Is automation now a prerequisite for pursuing those high prevalence indications. And for OXB, how do such developments in cell manufacturer change how you operate or adapt on the viral vector side? Has a follow-up. To follow up on the earlier cost question, is it such platform automation that drives the margin expansion? Or are the bespoke projects required how are bioproject required to drive this expansion?

Is automation a prerequisite, it's not, but it's a wise decision to go for an automated process. It's not only we're not only talking about economics. We're talking about probability of success or fairly right the other way around, with automation comes a much higher success rate. So it's a wise decision to -- automation from the beginning. But I'm not going to put words in your mouth, Arun, but again, it needs to be part of your very early decisions, right?

Yes. And just to talk quickly , it's hard to say what other companies do or don't think. I think for Cabaletta, we made the decision early on when we saw the scale of the opportunity that in order to meet the need for patients, we needed to invest heavily in automation. Automation is not the only thing we're investing in and our initial product, our initial programs are with -- starting with a traditional, we'll call it, manufacturing process. So that's not fully automated. I don't -- again, hard to comment on what others would say, but for us making that decision and that investment early was critical because we saw the scale of the opportunity and wanted to be able to deliver to that opportunity.

Is that changing anything for OXB? The answer is yes and no. In theory, it's not changing much. We're still providing the viral vector to our clients who then transfer to Cellares, who's going to take care of the cell manufacturing process. Practically speaking, I believe there is an impact. As I said, the success rate is going to be higher. So if the success rate is higher, I personally believe that then the treatments are going to be more affordable, which means that this treatment is going to be successful, if a treatment is successful, it will always be successful.

Thank you all for your questions. Thank you to the speakers. And I'll hand over to Frank to summarize and close the session.

Yes. Thank you so much. I hope it was a great session for all of you, which is now coming to an end, but before I let you go, I have a last one thing because I have one slide which for me is the most important slide. That's a slide which motivates me I wouldn't say every day because I'm motivated by definition.

But which I show to a lot of our people, of our newcomers every time they join the company is why we are confident. While I am so confident and so excited about the future of the company, but not only me, the team, the executive team, key shareholders are excited about us and the Board is excited. And this slide is a nice way to summarize everything. It's why we are so excited. And it's very simple, but it is summarize everything, high unmet medical need.

There are so many patients still suffering from rare diseases for oncology from -- sensing like that, there is a big, big need for such kind of therapies. And as it was said 2 times a day and sometimes it's 1 shot, and it's done, you are cured. This is a vision which is accompanying us. We have skilled and experienced people.

Believe me, I hear a lot of clients Hopefully, you say the same, Arun, yes. You have the best people. You just have to say that all the CTA most have very similar bioreactors, very similar suites, where is the differentiation coming from is coming from the people.

And here, we can build on 30 years of experience, 30 years is a lot just doing one thing. It started with nonviral vectors. We added AAV through France, we became also more agnostic in to others, we did during the pandemic -- nonvirus for AstraZeneca vaccine. This is -- we build off -- you can know other CDMO who can build that within a short time period. It's not possible.

I think we heard a lot about, thank you, Kyri, the innovation part, which will continue to guide us over the next years. We have now -- we are totally vector agnostic. We are geography agnostic. We can serve our plants form everywhere from our sites with the same level of quality and service. We have now adopted our processes. The transformation was a difficult one because when you are a development company and you want to transform the CDMO, it sounds very simple. At the end, we do the same, but we do it totally differently. And so we need different skills. We need different ways of working. We did different processes.

We have adopted all this now global footprint we are in the main hubs of the world for cell and gene therapies. And maybe one day, we will go to Asia. Sebastien is a new direction yes. client satisfaction.

Thank you, Arun. It was so nice to listen to you, yes, but this client satisfaction is very high and bringing a lot of clients back.

And we have, thank you Lucy, a clear path to profitability. So tell me -- this is not a compelling case. I don't know what a compelling case is. We are at the right time at the right market with the right service. So thank you so much. It was a pleasure to host you today here in London. And thank you for those on the web to join us. So we have the possibility to make a virtual tool outside we -- some of you have done it already, have seen that. So if you want to go virtually in a 2, we can offer this already, we have people experience outside. But there's another way to do. We are 2 ways to come and have some wings with us.

Yes. So thank you so much for being with us, and thank you for your interest in the company. It was a pleasure to have you with us today. Take care.

Hello, and welcome to OXB 2025 Preliminary Results. We are joined today by Dr. Frank Mathias, Chief Executive Officer; Dr. Lucinda Crabtree, Chief Financial Officer; and Dr. Sebastien Ribault, Chief Business Officer. [Operator Instructions] I would now like to hand the call over to Dr. Frank Mathias. Please go ahead.

Thank you so much for the introduction. Good morning to those in the U.S., and good afternoon to everyone else, and thank you for joining our OXB preliminary results briefing for the full year of 2025. Presenting alongside I just mentioned with me today is our Chief Financial Officer, Dr. Lucinda Crabtree; as well as our Chief Business Officer, Dr. Sebastien.

Next slide, please. Before we begin -- sorry, one back -- sorry. Before we begin, I will quickly run through today's meeting agenda as seen now on the screen. We'll begin with the business update, providing an overview of OXB's key achievements over the period and highlighting the steps we have taken this year to further strengthen our position as a leading global cell and gene therapy CDMO. I will then hand over to Sebastien, who will provide an update on the strong commercial momentum we are seeing across the business and the positive fundamentals of the cell and gene therapy market. Lucy will then take us through the group financial performance in 2025 before handing back to me for closing remarks and to open up the call for Q&A.

I would like to start by highlighting some of the key financial results from what has been an outstanding year for OXB. Overall, 2025 was characterized by sustained commercial momentum and disciplined execution, enabling us to deliver strong growth and operating EBITDA profitability across the business. Compared to 2024, we achieved a 33% increase in revenues at constant currency for the full year, reaching GBP 170.9 million. This represents an almost 90% increase in revenue since full year 2023 when we stood at around GBP 90 million. This growth reflects the successful execution of the company's pure-play CDMO strategy and the sustained demand as client programs progress. We saw continued growth in demand for our CDMO services across all vector types. We also kept converting our pipeline into revenue-generating programs as illustrated by the growth in the backlog this year. The backlog increased by 36% to GBP 204 million, and the contracted value of client orders increased in the same period by 20% to GBP 224 million, providing both strong visibility of revenue into 2026 and early 2027.

A key milestone was achieved this year as we reported our first full year of operating EBITDA profitability since our strategic refocus 3 years ago. We delivered operating EBITDA profit of GBP 8.1 million at constant currency compared with a loss of GBP 15.3 million in 2024. Finally, the group ended the year with GBP 96.9 million cash, providing a strong financial foundation as we continue to invest in capacity, capabilities and the long-term growth of the business. All these results demonstrate the strength of our commercial platform and the progress we are making in establishing a scalable, profitable business that provides sustainable value for our clients and shareholders. Having delivered performance at the upper end of guidance for the second consecutive year, we are confident in our ability to meet our ambitions medium- and long-term targets as we enter 2026.

2025 was, as said, an exceptional year for OXB in terms of strategic and operational delivery. Throughout the year, we successfully delivered on the strategic priorities we established at the beginning, achieving several significant milestones that strengthened our financial position and expanded our global presence. This performance reflects our disciplined execution and continued focus on creating long-term value. During the year, we strengthened our balance sheet by securing long-term capital through the completion of our GBP 60 million fundraising alongside a new loan facility from Oaktree. This has given us the financial flexibility to support future business needs and continue investing in our global capabilities.

We have also significantly expanded our U.S. commercial capabilities by acquiring an FDA-approved commercial scale viral vector manufacturing facility in Durham, North Carolina, U.S. As the integration process continues, the U.S. -- the Durham facility will strengthen our capacity to support late-stage programs in the U.S. and establish a robust foundation for future growth. As mentioned earlier, there has been strong commercial momentum throughout the year as reflected in the continued growth of our order book and backlog. Another example of this expansion is of our strategic partnership with Bristol-Myers Squibb after the end of the period. This agreement covers lentiviral manufacturing for multiple CAR-T programs and reflects the maturation of our clients' pipeline as well as a growing number of programs progressing towards later-stage development and commercialization. It also reinforces OXB's position as a trusted manufacturing partner for complex viral vectors, showcasing the depth of our technical expertise and our growing market share in this expanding field.

Alongside this commercial progress, we continue to advance our multi-vector multisite strategy. This includes the ongoing transfer of our AAV and lentiviral vector platforms to France, where lentiviral capabilities have now been established across all geographies. Operating as an integrated global network while also strengthening our operational excellence across the business enables us to serve our clients more flexibly as their programs progress through development. Central to achieving these results in our ongoing commitment to innovation at OXB.

Innovation is at the core of our strategy and is vital for developing our technology platforms, process development capabilities and client-focused technical solutions. Throughout the year, we have continued to invest in these areas to ensure that we remain at the forefront of vector innovation. This enables us to support increasingly complex programs and meet the evolving needs of our clients. This milestone collectively underpin our strong financial performance in 2025 with revenue reaching the upper end of our guidance and positive EBITDA being achieved for the first time under our pure-play CDMO strategy.

Turning now to Slide #6. I would like to focus on the acquisition of our Durham facility, which was announced last October and represents another significant milestone for our business. The rationale behind the acquisition was straightforward. We had experienced growing client demand, particularly from commercial manufacturing capacity in the United States, which is the world's largest cell and gene therapy market. North America is currently home to over more than 1,100 cell and gene therapy programs in development, which is 3x the number in Europe and significantly ahead of the Asia Pacific region. Last year, we were pleased to identify an FDA-approved commercial scale GMP viral vector manufacturing site in Durham, North Carolina. With its integrated drug substance and fill/finish capabilities, this facility has enhanced our global CDMO network and provides us with a complete end-to-end offering in the United States.

It will allow us to directly support the late-stage and commercial scale manufacturing needs of our clients in North America, including those in the AAV sector, which is a key growth driver in the viral vector manufacturing market. It is worth noting that acquiring an existing FDA-approved site was a more capital-efficient way of expanding our U.S. manufacturing footprint. It allowed us to avoid the time, cost and risk of building from scratch and more quickly -- and move quickly to meet client and market needs. Localizing our supply chain in the U.S. also offers attractive tax incentives and enable us to manage risks such as tariffs and export controls more effectively. Integration activities at Durham are ongoing, including a technology transfer from our Bedford site to prepare Durham for commercial AAV batch manufacturing.

Here on this slide, we can see our full global viral vector CDMO network. All of our sites are strategically located in close proximity to leading biotech hubs in the U.K., U.S. and France, positioning us close to our clients. In 2025, supported by our GBP 60 million equity placing, we strengthened our integrated global network further through targeted strategic investment across all sites. These enhancements will support our expansion in the cell and gene therapy sector and enable us to meet growing client demand. The scale of our network also provides us with operational flexibility to protect against regulatory, geopolitical and supply chain consideration by balancing capacity across regions.

To conclude now this section, I would like to take a moment to remind everyone of the foundation of OXB's success, and we remain a leading viral vector CDMO in this market. For now over 30 years, we have been at the forefront of innovation in viral vector design, process optimization and large-scale manufacturing. Our long-term commitment to innovation is reflected in our best-in-class capabilities, scalable platforms and state-of-the-art facilities today. Our exceptional team consistently delivers for our global client base and our track record of long-term partnership speaks for itself. We have produced more than 1,000 successful batches, GMP batches, submitted over 30 INDs and passed upwards of 65 successful audits. These milestones have established OXB as a trusted partner for global pharmaceutical companies, leading biotechs and emerging innovators across the value chain. With more than 40 active clients and growing demand across all vector types, we are well positioned for continued growth and to further strengthen our leadership in viral vector manufacturing.

I will now hand over to Sebastien, who will provide an update on our commercial performance and pipeline as well as the wider market conditions that drive our business forward. Sebastien?

Thank you, Frank. Good morning, good afternoon to everyone on that call. We can move to the next slide where I would like to start with the market situation. We're looking on the left at the market situation from 2025 to 2031, expected 2031. And we're looking only at the CDMO market size here for viral vectors. You see between 2025 and 2031, the 3 segments that will generate the growth over the next 6 years.

Starting with number one in pink, we will see still a significant number of early-stage opportunities. And we have excluded here the early-stage opportunities for AAV that we'll discuss in the segment #2. We have available platforms on the market and a track record today across multiple vector types, including lentiviruses, adenos, MDA and a few others. And our platforms are very well known for the high level of productivity and the high quality as well. Using proprietary technologies, we're able to deliver high-quality products with high productivity and yield, meaning that the cost per dose is greatly reduced. I think it's very well understood by the market that in the early-stage activities, we are a CDMO with a capital D that was even recognized yesterday night as we got the CDMO leadership award as the best innovative CDMO in viral gene therapy. We continue to innovate on this platform, and that will fuel our activities in the AAV space, the second category that you see here in green.

AAV is today and will remain for the next year, the fastest-growing segment. It today accounts for about 50% of the total CGT program, and we expect a growth year-on-year that's going to be above 20% more programs every single year. We are today an industry-leading player with the quality of our product with a ratio of full capsids on empty capsid that is absolutely exceptional, above 90% for the multiple serotypes that we handle when we still see on the market too many products delivered with a ratio full empty that is somewhere between 10% and 30% relatively low quality. We've shown that we were able to develop AAVs on multiple serotypes, wild type, but also hybrid capsids. And we've developed a dual plasmid concept where it's obvious that if you're using 2 plasmids instead of 3 with a very standard system, your cost of goods will go down.

Last segment here in blue, the shift of the market towards late-stage and commercial manufacturing. That's obviously where we will enjoy the GMP manufacturing revenues at large scale. We had commercial expertise in Oxford, the U.K. We've been manufacturing for more than 10 years now, commercial cell and gene therapy products. With the acquisition of the site in Durham, North Carolina, we can now deliver commercial products from U.K., but also from the U.S. We have, as we were building the network, transferred our platforms from one geography to another. We have that experience of tech transferring between the sites, but also tech transferring in processes that are coming directly from our clients. We know how to scale up. We can take a process at 50 liter, push it to 500, even 1,000 and sometimes 2,000 liter. And we have the regulatory track record to make sure that these projects will go smoothly through the regulatory discussions, whether it's in the U.S. with FDA, in Europe with EMA or in Asia with multiple agency already working with us on our existing commercial products.

Moving to the next slide, we're going to see OXB's position today in the market. As you see, based on our calculation and global data with the data published in January 2026, we're #4 in the viral vector CDMO market today. And if I look at the 3 companies that you see at the top of the graph, 2 of these companies had a volume of business that did not grow as fast as OXB last year or actually 2 of the top 4 with a very nice growth, and we've seen that the 2 others were struggling. It's indeed a market where competition can be fierce. But as we're one of the very few companies focusing exclusively on viral vector development and manufacturing, our clients understand that our efforts are not going to be diluted by another division working on biologics, by another division working on ADC or other modalities. And that's one of the reasons we are extremely attractive today. One focus only, one expertise, one experience, viral vector development and manufacturing.

If you look at the right side of the slide, you will see the growth of the market as it is expected for the CDMO space for viral vectors and gene therapy. The growth is expected to be slightly above 18%. If we look at what we achieved as a company over the past 3 years, meaning above 30% and what we plan to do during the next year, meaning around or above 30%, we will outgrow the market significantly. It's important to notice that for the period 2024 to 2025, we outgrew very significantly the 12% growth of the market for the same period.

Looking at how we've achieved that and moving to the next slide, you can note that our network of sites today has changed the way we're perceived in the market. We're not only a U.K. or European company. We're seen as a global company, and that's the reason why our pipeline of opportunities has changed significantly. Let's look back a year ago on the far left of the slide, 10% of the opportunities of the pipeline were for the French sites. Almost 3/4, 72% were for U.K. and 18% for our U.S. site in Bedford. Fast forward 12 months, Q1 2026 on the right side of this graph, the share of U.K. is now below 50%, 46% and we've increased very significantly the number of opportunities that can be handled by the French site, moving from 10% to 23%.

I'm going to say at the bottom of the bar here with the blue segment, 12% of unassigned projects. That's a key aspect of the pipeline diversification. We now have clients coming to us saying, could you please show us what the project would look like if we're doing the development and manufacturing in the U.S. or if we're doing the development and the manufacturing in U.K. and France. And that's why some of the projects are not assigned because they could go in one geography or in another one.

At the very top of the bar, we see already now and since Q4 last year, the impact of the Durham site where we've transferred our GMP activities. Bedford is at the top with 7% of our pipeline opportunities and Durham below with 30% of the opportunities. Again, today, we can deliver anywhere the different vectors at development stage, clinical stage, but also commercial stage. And that's the positioning for OXB that is not new, but can still appear relatively new to some of the prospects who come to us. I expect that the pipeline will continue to be redistributed through the year. The Oxford share will continue to go down when the share of the French and U.S. sites will continue to go up as we're filling this capacity.

In the middle, you see the split by geography for 2025. For those who were on the same call about 2 years ago, the European component was very small in the 10-ish percent. We're today at 40%, plus 7% in APAC and U.S. relatively stable, represent 50% of the opportunities. I think that the APAC segment in which we invest through more business development activities or through licensing deals like the one we recently signed with VVMF, the APAC segment will continue to go up. U.S. will probably stay as the strongest segment since it's a very mature market with a lot of opportunities. How did that change our activities, meaning what's been ordered and what is ready to be delivered? Well, both numbers, the backlog first, activities signed but not delivered yet and the orders both went up.

Very happy to report that the backlog went up by 36%, up to GBP 204 million, which means that we have a lot of confidence for 2026 that we will hit our revenue target as we have GBP 204 million of activities that have been ordered but not delivered yet, very shy of the revenue target that we have for the year, although the backlog is not current just 2026, but also part of 2027. Very happy to report as well that the orders finished at GBP 224 million, meaning GBP 4 million above the corporate target that we had set at GBP 220 million. Very strong order intake, a backlog that has grown at the pace that we expect for the company, meaning 30-plus percent, and we're ready to deliver for 2026.

To continue on the pipeline on the next slide, you will see a view that we've not used before. The pipeline has a dynamic that is interesting because when you sign, and that's good news and you contract, the pipeline goes down. It's not an opportunity anymore. It becomes a contract and an order. So the real way to look at the pipeline in a calendar year, how many opportunities have we handled during the 12 months of the calendar year.

The right way to look at it is to put together the gray bar that you see at the bottom, pipeline at the end of the year with opportunities not signed yet and put on top in pink, the opportunities that were signed, they disappear from the pipeline, but they were part overall of the opportunity that we handled. The pipeline, excluding the signed opportunity, grew between 2022 and 2025 by 105%. We doubled the size of the pipeline. The objective was to stabilize the pipeline between 2024 and 2025 because we had signed in '24, a number of opportunities, a big number of opportunities to be delivered in 2026. So we wanted to sustain the level of the pipeline, still grow the volume of orders to be more confident in the 2026 revenue delivery.

So if we look now only at the pink part of the graph and the number is not on the slide, we grew the volume of order between 2022 and 2025 by 146%, which means if you combine the 105% of pipeline, excluding signed and 146% of the signed opportunity that overall, the volume of opportunity that we've handled comparing 2022 to 2025 grew by 117%, very significant increase in all categories, but some more than the others. If you look at the graph in the middle, you will see, and that's the view as of January 2026, that for the very first time, the company has more opportunities in the AAV space than lenti. Oxford Biomedica was known as a lenti company. We moved to multi-vector with the tech transfer of our activities between the geography. And for the very first time, we see 43% of the opportunities with AAV versus 40% with lenti. Multi-vector more than AAV and lenti that are the core offering. You see with the other colors, the opportunities we have in the pipeline today for other vectors on which I will not elaborate today.

Opportunities by clinical phase, starting with the left part of the pie chart. If you accumulate the Phase II to the Phase III and the commercial activities, about 50% of our pipeline is with large-scale preparation of commercial activities or already commercial products. The remaining 50% preclinical and Phase I are precisely here 49%. So very well balanced. I mentioned it before, we're a CDMO. We want to make sure that we have development opportunities as we have manufacturing opportunity. So very happy with the diversification of the pipeline and the growth of the pipeline and of the orders.

Moving to the next slide, which will be my last slide before I hand over to Lucy. It's important for us to push these programs from preclinical activities through development, Phase I, II, III and commercial, and that's exactly what you see here on the slide. If you look at late stage and commercial together back in 2024, we had 5 programs. In 2025, that became 6 programs. We're today at 8 programs. We expect that one of them will become commercial this year at least, probably 2 and another 2 should become commercial next year. So very happy with the progress of our clients who have been working with us for many years, and you see some of the logos at the bottom, some of them being obviously new. But as said, we continue to work on the early-stage activities that will fill the future capacity for clinical manufacturing late-stage and commercial in the future. The client demographic is not very different from what we had in the past, emerging biotechs, but also established biotechs and big pharma. The others segment includes incubators, universities who are funding feasibility studies, investment funds and a few other structure that would not be classified as emerging, established or big pharma. In summary, very good process on the commercial side, a lot of confidence for the future. Very happy to see these programs progressing because it means at the end of the day, that this treatment will go to patients, and that's the reason why we are in this activity.

Lucy, I'll hand over to you.

Thank you, Sebastien. So turning to the next slide. I'm very pleased to take you through our 2025 financial performance. This has been a year of great progress for OXB, one where strong execution, commercial momentum and disciplined cost control have translated into a step change in revenue, financial strength and importantly, operating EBITDA profitability for the full year. If we start with revenue, we delivered significant growth in 2025 with full year revenue increasing by 33% on a constant currency basis to GBP 170.9 million. This performance was towards the upper end of our guidance and reflects strong and sustained demand for our CDMO services. Looking at this in a little more detail, manufacturing revenues increased as clients prepare for commercial launch, while development revenues grew as more programs progressed along their clinical development pathways. Procurement services grew substantially, demonstrating our growing maturity as a CDMO.

Turning to profitability. We delivered a major improvement in 2025, with full year operating EBITDA moving into profit at GBP 8.1 million on a constant currency basis compared with a loss of GBP 15.3 million last year. Underlying operating EBITDA was GBP 3.3 million, excluding the one-off nonrecurring gain relating to the Durham acquisition and other related costs. Achieving EBITDA profitability marks an important step forward for the business and reflects both the strength of our revenue performance and the continued discipline across our cost base as we drive greater operating leverage through our global network. It also supports the expectations we have set for 2026 as well as our medium-term outlook for continued EBITDA margin expansion and profitable growth.

Looking next to the balance sheet. We ended the year in a much stronger financial position with cash of GBP 96.9 million and net cash of GBP 55.4 million. During the year, we further reinforced our balance sheet through the GBP 60 million equity placing and the establishment of a new 4-year loan facility of up to $125 million with Oaktree. This strengthened financial position provides the financial flexibility to continue investing in our global network, including our expanded U.S. footprint and ensures we are well capitalized to support increasing client demand and the growth opportunities ahead.

Looking now at our commercial KPIs, as Sebastien set out earlier, we are seeing increasing late-stage activity across the pipeline, and this is reflected in the strong commercial momentum we delivered in 2025. Contracted client orders increased by around 20% to GBP 224 million, supported by both new and existing clients and include signed orders for late-stage and commercial activities backed by binding forecasts. Revenue backlog also grew significantly, rising to approximately GBP 204 million, an increase of around 36% year-on-year, providing a strong indicator of future revenues and continued growth through 2026 and beyond.

Turning to the next slide. I'd like to take a closer look at the relationship between revenue and costs. 2025 demonstrates the operating leverage inherent in our business model. On a constant currency -- on a non-constant currency basis, revenues grew 31% year-on-year to GBP 168.7 million, while total expenses increased 17%, materially below the rate of revenue expansion, reflecting both the strength of demand and our continued cost discipline as the business scales. Manufacturing revenues grew 19% to GBP 81.1 million, driven by increased batches for clinical programs and for clients preparing for commercial launch. Development Services also delivered a strong performance, increasing 27% to GBP 60.1 million as client products moved further along their clinical development pathways, including higher levels of process characterization and validation work.

We also saw substantial growth in procurement and storage revenues as more clients undertook commercial preparation activities, reflecting the increasing maturity of our CDMO offering and our ability to provide stability of supply as programs move closer to launch. As mentioned, our cost base remained well controlled against this backdrop of strong revenue growth. Total expenses increased 17%, well below the 31% growth in reported revenues, demonstrating that clear operating leverage. Cost of sales increased in line with higher production volumes, while operating costs reflect the planned absorption of the Durham facility and associated integration spend.

Administration expenses were impacted by nonoperational items, including a GBP 4.6 million FX impact and GBP 1.3 million of acquisition-related costs. Innovation and commercial costs were managed carefully, while investment focused on priority programs and technology platforms, reflecting the disciplined but continued commitment to advancing our CDMO capabilities. Taken together, this all underscores the scalability of our model and provides a strong foundation for margin progression as revenues grow.

Turning now to cash flow. We ended the year with a strong cash position of GBP 96.9 million, supported by improved operating performance and the actions we took to strengthen the balance sheet. Operationally, we generated net cash from operations of GBP 0.5 million, inclusive of the R&D tax credit received during the year, a very significant improvement compared with the GBP 50.7 million outflow in 2024. This result reflects stronger underlying performance and favorable working capital management, including higher client upfront payments. Financing cash flows reflect the GBP 60 million equity raise and activity on the Oaktree facility, while investment cash flows include the acquisition of the Durham facility and target investment across the network. Altogether, these movements contributed to the year-end cash balance of GBP 96.9 million and ensure we remain well capitalized to support client demand, progress our strategic investments and execute against our medium-term growth ambitions.

Turning now to 2026. This slide sets out our guidance for the year and how it supports OXB's medium-term growth trajectory. For 2026, we are reiterating revenue guidance of GBP 220 million to GBP 240 million on a constant currency basis. Around 60% of this is already covered by contracted client orders, increasing to more than 80% when we include the risk-adjusted pipeline relevant for 2026, giving us a high level of visibility as we enter the year. 2026 will be more second half weighted. H1 will absorb the planned routine maintenance shutdowns as in prior years, alongside nonrecurring costs linked to the completion of AAV and lentiviral technology transfers and the continued integration of Durham. As a result, H1 is expected to be loss-making at the EBITDA level. In H2, we expect a strong uplift as we benefit from the completion of the AAV and lentiviral technology transfers in France, the ramp-up of Durham revenues, supporting a move to double-digit operating EBITDA margins in the second half and around 10% for the full year.

We now expect capital expenditure, including strategic investments for future growth to be approximately GBP 50 million in the aggregate for 2026 and 2027, a reduction from the GBP 60 million previously communicated. On growth, we remain highly confident in the outlook. We continue to target above-market revenue expansion with our revenue CAGR for 2023 to 2026 expected to exceed 35%, significantly ahead of the 18% CAGR projected for the outsourced viral vector CDMO market. Following the delivery of EBITDA profitability in 2025, we also expect continued margin expansion in 2026, supported by increasing late-stage activity, rising demand across all vector types and our strong track record in commercial delivery. Taken together, this gives us strong visibility for 2026 and a clear foundation for the medium-term outlook, which I'll come on to next.

Looking beyond 2026, our outlook remains very strong. We continue to target 25% to 30% year-on-year revenue growth in both 2027 and 2028, driven by increasing late-stage and commercial activity and sustained demand across all major vector classes. As revenue scale, we also anticipate continued margin expansion with operating EBITDA margins of at least 20% in 2027 and the potential to approach around 30% over the longer term as utilization improves and operating leverage builds across the network.

This growth is underpinned by a high-quality contracted backlog, expanding U.S. capacity through the Durham facility and the operational leverage already emerging across our sites. Combined with deep client partnerships and our multi-vector capabilities, we believe OXB is exceptionally well placed to capture a growing share of the outsourced CDMO viral vector market. Stepping back, everything you've heard today from the strength of our client demand to the progress across our network and the discipline in our operational cost base gives us real confidence in the opportunities ahead and in OXB's ability to deliver sustained long-term value.

With that, I'll hand back to Frank to close the presentation. Thank you.

Thank you so much, Lucy. So indeed, before we conclude today's meeting, I would like to briefly revisit the slide I have shown -- shared with you at the beginning of the presentation, which outlines the business achievements over the past year. 2025 was definitely an outstanding year for financial, commercial and strategic delivery. By strengthening our financial position, we have been able to expand our network by the acquisition of our Durham facility and invest in innovation across our sites, supporting our ambition to increase our share of the global CDMO market. Our robust commercial momentum has enabled us to deliver on our financial guidance and achieve our first full year of EBITDA profitability since our strategic refocus. So all this, as mentioned many times in the presentation today, provides a foundation for growth in 2026 and beyond.

Now looking into 2026, our focus remains on executing the priorities that will continue to build momentum across the business. A key part of this is the integration of our Durham site and increasing optimization of the expanded network. With technology transfer underway, commercial scale AAV batch manufacturing will follow, and fill and finish capability will follow thereafter completing our end-to-end U.S. offering. Meanwhile, the strong commercial traction we saw in 2025 provides a solid foundation for converting that momentum into multiyear backlog growth and strong revenue visibility. We are also very focused on improving operational efficiency across the network with a view to increasing throughput, optimizing planning and enhancing reliability as volume increase.

In addition, we will continue to strengthen and optimize our multi-vector capabilities across sites, enabling lentiviral vector, AAV and other vector programs to be taken on, transferred and scaled across the network in a flexible way that supports high utilization. All of this is underpinned by our continued investment in our people and capabilities, which involves building leadership depth, technical expertise and the organizational strength needed to support growth across the network. These priorities provide a clear direction for the year ahead, grounded in innovation and disciplined execution. They will support continued strong progress in our revenue and margin ambitions for 2026.

And on my summary slides in conclusion, let me now tell you why we are so confident in our ability to deliver sustained value creation. The market opportunity is significant with a growing pipeline of cell and gene therapy products in development and continued regulatory approvals, reflecting the growing maturity of these modalities. We are seeing this progression mirrored in our client portfolio, as shown by Sebastien, with more programs moving into late-stage and commercial supply. Our contracted order book now includes an increasing proportion of these mature programs, a trend that has been further reinforced by our multiyear commercial supply agreement with Bristol-Myers Squibb.

Our newly acquired Durham facility places us at the center of the world's largest cell and gene market. It adds cost-efficient, commercially scaled capacity and integrated fill/finish capabilities, completing our U.S. end-to-end offering. Taken together, our enhanced infrastructure, world-class talent and 3 decades of viral vector expertise position OXB to deliver above-market growth and expand margins while building momentum for the years ahead, as Lucy has clearly shown.

So that concludes the slides for today, and I would like now to open up the floor to any questions.

Moderator, please.

[Operator Instructions] We now take our first question from Charles Weston of RBC.

Two topics, please. First of all, on Durham, you've explained in the presentation the capacity that it brings. But could you also touch on the capacity expansion opportunity, and I guess, the brand that it gave you as well in the U.S.? And how did it become a part of the BMS commercial program deal so quickly after the acquisition? That's the first one. The second is just a couple of financial questions, please. What would you expect at the current FX rates, the FX impact to be on revenue and EBITDA for 2026? And also on energy or general inflation, what is your exposure in hedging given the fluctuation in pricing?

Sebastien, you take the first one?

Yes, I'll take the first one. So the site in Durham comes with 2 fully functional GMP suites plus one fill and finish line, and we have enough space equipped -- well, not equipped, sorry, we have enough space functional but not equipped to bring online very quickly a third GMP suite. We would just need to add the equipment. The infrastructure is completely in place, including HVAC control system. Yes, only the equipment is missing. Same comment for a second fill and finish line that we could bring online very, very quickly. Beyond the space that is already functional, we have a fallow space that would give us the opportunity to double the final capacity. And when I'm saying final capacity, I'm talking about the 2 GMP suites plus 1 equipped and the 2 fill and finish line, which means that we could literally go to 6 GMP suites.

And while I would not see the point in bringing 4 fill and finish lines together, but there is enough space for that. There are also other areas today installed and fully equipped like the MSAT lab for tech transfer. So significant capacity. How did that play in the commercial discussion with BMS? It did and it did not. The commercial negotiation with BMS was ongoing way before we started the discussion. of the Durham acquisition. It's just another opportunity for BMS to get commercial products delivered from U.S. and not just from U.K. So I wouldn't say that it has changed the profile of the discussion with BMS as it didn't change our appetite for the acquisition of Durham. The 2 are obviously related because I mean, one can impact the other, but I cannot say that one influenced the other at that stage.

I'll take the FX and energy price question. So in terms of FX, I mean, we ended the year around [ 1 35 ], [ 1 34 ]. I think we're sort of bouncing around that level. And so at these rates, I'd expect the FX impact to be relatively minimal. In terms of energy rates, we locked in a lot of our rates fairly recently, most of our contracts come for renewal in 2027. So I think, again, some impacts, but all baked into expectations.

And we'll now take our next question from Zain Ebrahim.

Zain Ebrahim, JPMorgan. My first question is just on the order trend because overall, the orders were very strong in terms of 20% growth in '25, but it looked like the second half, you saw a deceleration in orders signed to GBP 75 million from GBP 150 million or so in the first half. Is that just lumpiness and phasing and maybe more -- or what else is driving that? And maybe more importantly, for the first -- or the first quarter so far this year, what's the latest you're seeing in terms of demand trends from customers across your portfolio? That's the first question. And then second question is just on the commercial contracting momentum. So you now have 3 commercial contracts and 2 previously. So can you remind us how many commercial contracts do you anticipate you'll have by the end of the year?

Yes. So starting with the orders, I think I mentioned it during my presentation, but the orders came at the end of the year above the target. The target was GBP 220 million, and we signed GBP 224 million. The reason why we need to have an order target is that for obvious reasons, we cannot sell twice the same slot. When it's sold, it's sold. So since most of the manufacturing slots that we wanted to sign for the year have been sold in H1, we had to refocus the BD efforts on some other activities, including development activities or feasibility studies that have a lower value than the GMP manufacturing.

We had booked almost 3 GMP suites, I mean, pretty much at the end of Q1 last year. So H1 was a big semester. For that reason, there are activities that we couldn't sell anymore for H2. On top of that, 2024 had been extremely strong. And that's the reason why the backlog was high already mid-2025. And again, there is so much you can do with one slot, you can make only one batch. So orders above target as planned, it was GBP 220 million. As executed, it was GBP 224 million. That's filling the capacity we had planned. Remember that in our business, it's not only about having the slot on an Excel sheet. You need the GMP suite fully functional, the people hired, onboarded, trained and the typical training of GMP operator is about 6 months before activities can be done, plus another 6 months before we see the right level of autonomy. So we set more than 1 year in advance the targets for the capacity we want to put in place, and we fill the capacity that we wanted to fill.

Looking at Q1, the dynamic is as expected. I must say as well that since we have a relatively large volume of activities with existing clients who are giving us long-range plans and forecast, we see what we were expecting. On your second question, 3 commercial programs right now, we see one likely to be approved before the end of the year. A second one potentially, but I have less visibility because we're still receiving questions from the regulatory agency, and it's not only the willingness of our clients, it's obviously the pace at which the regulators review the dossier. So one, yes, maybe 2, and we see another 2 next year if the plans go as expected. So far, that is the case.

And we'll now take our next question from Kane Slutzkin of Deutsche Bank.

Just on the orders, could you comment sort of on the '25 orders, the sort of split between new clients and existing programs? And then just on the modeling, just on margins, you obviously sort of pointed out that gross margins saw a reduction on mix. Just wondering what we should expect going forward there, given it looks like consensus is sitting in the mid-40s this year. So just a little bit on gross margins and that mix would be interesting.

And then just maybe a final question. Just following Gilead's acquisition of Arcellx, does the shift from a sort of partnered model to full ownership by Gilead sort of change anything, whether it be pricing or margin dynamics on the sort of vector supply agreements in the future? I'm not sure if you can comment on that, but if you can, anything would be useful.

Well, to start with Arcellx, contract is a contract and it's not because you have a change of ownership that a contract that is in place between OXB and a client is going to change. So we don't expect any change. On the margins, I'm going to give you my view on the margins on the commercial side, and I will let Lucy elaborate. We don't expect to see any difference of margin between the vectors, between the geographies and between the type of activity that we're running. That's not the way that we price our services. So I do expect that the margins in '26 are going to be similar to the margins that we had in our contract in 2025. That's for the top line part that is under the control of the commercial team. Lucy, you may want to comment on the gross margin.

Yes. I mean you've answered it perfectly. I think the level that you cited is the right level to think. Procurement services is expected to be a growing element of our revenue stream, but so are the higher-margin manufacturing and development services as well. So I would expect that mix to stay relatively the same, certainly in the near to medium term.

Was there a first part of your question that we've not answered?

Yes, just on the orders, sort of can you comment on sort of the split between new clients and sort of existing programs?

I don't have the split in front of me. The only thing I will say is that we have no targets of making more orders with existing clients than with new clients. It's not an objective per se. If one of our existing clients, and we have clients today who have multiple assets with us, tell us we have one new asset for you. I have no reason to say no to work with another client. It's a new asset, it's a new program. If it's an existing relationship, it's even better for us because, I mean, we know how to work together, the ways of working are in place. The trust is in place, the communication channels are in place. So we have no reason to privilege one versus another. I've had and I continue to have the same discussion with the BDs providing that the projects are real, that these companies are well funded, that they have a strategy that makes sense and that we see that scientifically, technically and from a business perspective, it makes sense, first signed, first served.

And we'll now take our next question from Julie Simmonds of Panmure Liberum.

I was just wondering, given the sort of change in balance between lenti and AAV, whether that makes a difference at all in terms of sort of pricing, the competitive situation, the technologies or the facilities that you're using for that, whether it's having an effect on the business? That's sort of first question. And then possibly related, just wondering, now you've got the additional facilities in the U.S., is that making a change in terms of what demand customers put on the U.K., whether they want to do things in the U.K. or not and whether that's changing, obviously, the U.K. has a bit of a lengthy specialization there?

Pricing, no. I mean, back to the previous question, we don't expect to see different margins between vectors and geographies. So it's not because it's an AAV that the margin is going to be different. And by the way, if you look at regulations, meaning what is expected out of development and a clinical batch, you don't have regulations for AAV versus regulations for lenti, you have regulations for cell and gene therapy. So no difference between the vectors. Is the competition different? Slightly. The big players are the same. They usually offer lenti and AAV.

If you look at the small players, indeed, you have -- I wouldn't call that a specialization, but it's a specialization by default because they often don't have the critical mass to offer both. So indeed, you see players that can be AAV only or lenti only or claim that they can do both, but they have actually the tools and the experience only for one. So competition is changing slightly. If you're looking at the local environment and the local players, it will change. If you're looking at the global level because we're a global player, that doesn't change much. Our top 3, top 4 competitors are exactly the same, whether it's lenti or AAV.

On your second question, will the acquisition of Durham change the demand in U.K.? Of course, it will. And that's exactly the reason why we made that acquisition. We had demand for commercial manufacturing in the U.S. We were already expanding Bedford, and we stopped the expansion of Bedford to make the acquisition of Durham faster, cheaper, a team in place, very experienced, a track record, FDA stamped, so we have many reasons to do it. So of course, it will change the demand for U.K. for very good reasons. People were asking for U.K. because that was the only commercial center. Now we have two. So we see demand for execution in the U.S. That's exactly what we expected and exactly the reason why we wanted to expand our U.S. capabilities and capacity. So I hope it will continue to be the case.

And the impact will be positive on the business, right, Sebastien?

Right. Yes. Very positive impact, more discussions on late-stage activities than what we anticipated already, although it's not even 6 months since the acquisition.

And we'll now take our last question from Miles Dixon of Peel Hunt.

Three quick questions, if I can. The first one, you talked about the risk-adjusted pipeline now bringing you up to 80% coverage of the FY '26. Can you give us a clue just to how conservative that risk adjustment is? On the second one, thinking about the factors affecting the first half, second half split, you talked about the planned shutdowns in the first half. As you build out your portfolio of sites, might we expect that, that scale will allow you to smooth that into future years?

And then finally, just returning to Charles and Julie's question on the -- well, the capacity really, but this time focusing on Durham versus Bedford. I mean, aside from the success that you've delivered at Durham, with Bedford down to now, I think I saw on one of your slides, 7% of group revenue. Do you potentially have too much footprint and capacity at Bedford?

Shall I take the easy one first, the H1 and H2 split and then I'll hand to Sebastien. Miles, yes is the answer to that. Of course, over time, as you scale, you can sort of manage the shutdowns. So I think the answer to that is a simple yes. So back to Sebastien.

I'm going to start with the last one. We got the engineering phase in Bedford, that was at the detailed design, and we were planning to expand Bedford to GMP capacity. With the acquisition of Durham, we stopped the expansion of Bedford. So do we have too much capacity? No, Bedford is process development only. We did not expand on the GMP side like we wanted. That expansion was replaced by Durham. So Durham is GMP. Bedford is PD, but there is no duplication of capabilities. The only capabilities that were in Bedford and not used anymore in Bedford has been transferred to Durham. I'm thinking some analytical methods, for example. But no, no, it's not a duplication of the capabilities between the 2 sites. It's a phasing. The project starts in Bedford with PD and pilot and continues in Durham with the GMP activity.

On your first question, the 80% of the year is not the weighted pipeline. It's the booked orders for -- Lucy, correct me if I'm wrong, but 60% so far. And we're signing every day. So I've seen we signed things between yesterday and today, so it's very slightly above 60% now. And 20% is what we see in the pipeline that would correspond to signature in the next weeks. It's a very short-term view of what we have in the pipeline. So it's not even the full weighted pipeline. It's the weighted pipeline that has an impact on 2026 revenue and for which we see signature allowing the start of execution in the next less than a quarter usually. We usually look at the period over a couple of months. It's not even taking into account some of the new opportunities that have a very short negotiation time frame that we started 4 weeks ago. One of them, they have the meeting to make the decision today, 4 weeks negotiation very quick, and it's a very large-scale project. So 60% fully booked, 20% in the weighted pipeline, but not the entire weighted pipeline, the portion of the weighted pipeline that we see with immediate application.

So we need to end now. So that brings today's full year 2025 analyst results session to a close. Thank you all for your time, participation and engagement and for the thoughtful questions you asked in the last 20 minutes. This has been a pivotal year for OXB. I hope it was clear, a year in which we have delivered on our commitments, achieved important strategic milestone and laid the groundwork for future growth. So we appreciate, as always, your continued support and interest in the business and look forward to updating you on your progress -- on our progress as we continue to execute our strategy and realize our medium-term ambition. Thank you so much, and see you soon.

Hello, and welcome to the OXB's 2025 Interim Results Presentation. We are joined today by Dr. Frank Mathias, Chief Executive Officer; Dr. Lucinda Crabtree, Chief Financial Officer; and Dr. Sebastien Ribault, Chief Business Officer. [Operator Instructions]

I would now like to hand the call over to Dr. Frank Mathias. Please go ahead.

Good afternoon, everyone, or good morning, depending where you are. So for those on the other side of the ocean, good morning, and thank you for joining us for OXB's 2025 Interim Results Presentation. It's a pleasure to be with you today virtually this time.

With me today, as already said, is our Chief Financial Officer, Lucy Crabtree, who came on board just over a year ago and quickly established herself as an integral part of the team. And with our Chief Business Officer, Sebastien Ribault, who plays a key role in driving our commercial progress.

Next slide, please. So here, obviously, is our legal disclaimer. As always, as a quick reminder that today's presentation includes forward-looking statements. The details are here in the disclaimer.

Please go to the next slide. So let me begin by outlining today's agenda. I will start with an overview of the key achievements over the period, highlighting the steps we have taken this year to further cement OXB's position as a leading global cell and gene therapy CDMO. I will then hand over to Sebastien to provide an update on our strong commercial performance, and then Lucy will take us through the group's financial performance. I will finish the presentation with some closing remarks, after which there will be a Q&A session.

So please, next slide. So the first half of 2025 has been a period of strong delivery for our company, driven by sustained high demand for our CDMO services across all vector types. Our performance in the period has also led a few days ago to our inclusion in the FTSE 250 Index, which, in my view, reflects the progress we have made in building a stronger and more resilient company. Building on the growth seen in 2024, revenues continued to grow in the first half of the year, increasing by 44% to GBP 73.2 million. Meanwhile, contracted clients' orders grew by 166% year-on-year to GBP 149 million, providing us with clear revenue visibility.

This growth has been driven by several factors, including increased lentiviral vector manufacturing for clients in clinical development as well as those preparing for late-stage or commercial activities. Thanks to the growing revenues and careful cost management, we also achieved a significant improvement in profitability.

Our EBITDA loss narrowed significantly by GBP 12 million to GBP 8.3 million for the period compared to a loss of over GBP 20 million for the same period in 2024.

Turning your attention to the operational side of the business. We continue to deliver operational excellence by further aligning operations and driving manufacturing optimization across the U.K., U.S. and France. This has resulted in improved efficiency and agility, strengthening our ability to respond to client needs across geographies. In line with our multi-vector, multi-site strategy, we started to transfer our AAV vector platform to France. Process development and pilot manufacturing capabilities for AAV are now available for clients in France with transfer of GMP capabilities targeted for completion by the first half of 2026.

Similarly, in the U.K., additional lentiviral GMP manufacturing capacity is also due to be added by the first half of 2026, following strong demand for both manufacturing and development services.

To support the growing number of late-stage client programs, we bolstered our balance sheet with a new debt facility of up to USD 100 million and an equity placement of GBP 60 million in this case, post-period in August. We will strategically invest this added financial flexibility to strengthen our CDMO network globally including commercial stage AAV manufacturing and fill and finish capabilities in the U.S. This impressive first half year performance, combined with our robust balance sheet, underpins our reiterated full year 2025 guidance and supports our medium-term outlook for sustained growth and profitability.

Next slide, please. The reason OXB continues to succeed is clear. We combine differentiated capabilities with a proven track record of delivering and unmatched expertise in viral-vector manufacturing. For now more than 30 years, we have been driving innovation in vector design, process optimization and large-scale manufacturing and our track record speaks for itself, about 1,000 successfully released GMP batches, more than 40 client programs currently, 30 INDs and 65 successful audits worldwide.

Add to this, our highly experienced business development team, very talented scientific professionals throughout the company, state-of-the-art facility, scalable platforms and a global footprint in key biotech hubs, and we are all well positioned to meet the complex development and manufacturing needs of our clients.

Next slide, please. Building on the previous slide, here, you can see the scale of our global viral-vector CDMO network strategically located across leading biotech hubs in the U.K., U.S. and France. This footprint not only places us close to our clients in their end markets, but also provides resilience against tariff pressures, regulatory shifts and other external headwinds by balancing capacity across regions.

As mentioned earlier, we raised GBP 60 million to strengthen this network with funds to be directed towards expanding our U.S. AAV commercial capabilities and targeted investment across the network to enhance quality, productivity and yield, all to meet growing client demand.

I would now like to hand over to Sebastien, who will provide an update on our commercial pipeline and the market dynamics that continue to support our business. Please, Sebastien.

Thank you, Frank. Good morning, good afternoon, everyone. We can move directly to Slide #8 and talk about the market situation to start.

[Audio Gap] pre-registration have increased. The most impressive, at least for me, is to look at the last three categories, the Phase II, the Phase III and the pre-registration. The Phase II programs have moved from slightly shy of 280 to 330, which means an additional 50 programs in Phase II for cell and gene therapy. Likewise, Phase III is moving from 34 to 45 and pre-registration from 5 to 13. It seems like it's a small increase, but it's a growth that is above 200%. That is the reason why we continue to see a strong momentum all around the world in the number of CGT programs. The programs have progressed through Phase I through Phase II, and they are now either entering Phase III or being at pre-registration phase.

Looking at the right side of the slide, we see that 10 to 12 CGT approvals were expected in 2025 across U.S. and Europe and a number have already been approved as you can see here. It's always difficult in the case of Oxford Biomedica to talk about CGT, because although we are a CGT company, we're specialized in viral-vector manufacturing and some programs can be cell therapy only as we have listed one here, Zemcelpro from ExCellThera, is a cell therapy program only that does not require viral vectors. Still, the trends are directly applicable to the OXB business.

And if we move to Slide #9, the growth of the market is the same growth that we enjoy when we look at the order value for Oxford Biomedica. Starting on the left side of the slide, we had signed GBP 56 million of orders at the end of H1 last year, and we have signed GBP 149 million at the end of the first semester of this year, corresponding to 166% growth. It's a very significant increase.

And if we look now on the right side of the slide, how this translates in terms of pipeline value, we try to indicate here what the pipeline situation was at the end of H1 2024. So you see the pipeline by category of vector, and we've listed here the lenti pipeline in pink, the AAV pipeline in green and all other vectors in dark blue.

At the end of H1 2024, the pipeline was around $570 million. We've added on top what we had signed at the end of H1 since the pipeline variation are due to what enters new opportunities, but also what exits the pipeline, meaning the orders we signed, if there are orders, there are not any more opportunity. It means that the total volume of opportunities that we had handled in H1 2024 was up to $642 million. Doing the same exercise at the end of H1 2025, you see that the sum of the opportunities, which were at $541 million for what stays in the pipeline at the end of H1, plus what we had signed was giving us a value of $732 million, plus 14% compared to last year.

That plus 14% compared to what we have seen on the previous slide, which was 7% year-on-year growth of all the programs accumulating preclinical Phase I, II, III and pre-registration shows that OXB is growing above market.

Not a big surprise, and I often hear that there is an excess of capacity, indeed physical capacity, but there is a gap in the number of experts available for the late-stage activities. And that's where OXB has a value. And that's the reason why lenti remain a key driver of our pipeline today, although the AAV value is significantly increasing from $91 million last year to $150 million this year.

Moving now to Slide #10. It illustrates how the OXB strategy had an impact on the type of contract that we signed. Our clients are happy with OXB. We see it through the customer satisfaction and more than 80% of the signed contracts are from existing clients, reflecting not only the satisfaction, but the fact that they progress through late-stage activity, as you'll see in one of the next slide, but let's stay on this one for a couple of more minutes.

We have a lot of new clients in the AAV space, something that we've not pictured on the slide here. But in H1, 100% of the contracts from new clients were AAV contracts. That reflects the strong growth we have seen in the pipeline, but also the fact that OXB is not seen only as a lenti company now, but as a lenti and AAV and other vectors companies as we have defined it in the One OXB strategy.

We didn't want to diversify only in terms of vectors, but by geography as well. And if in the past, the North American clients were 80% to 90% of that geographical split. Today, it's 60% with a significant share for EMEA and for Asia Pacific, which shows that people understand that we're now operating as a global company that can deliver at the minimum two vectors per site.

Moving to the next slide. You'll see the evolution that we decided to show you over 3 years. In each category, preclinical and development, early stage, late-stage and commercial activities, you have at the bottom in gray, the bar that corresponds to the number of programs on which we were working in September 2023. And at the top, you see in dark blue, the number of programs that we are running in September 2025.

We have 25 preclinical and development programs in 2023. 14 today. But if you go to the category just below early-stage clinical, you see that we have 23 early-stage clinical to be compared to 14 only in September 2023. What does that mean? It means that many of our clients who were at feasibility stage have progressed into Phase I and stayed with us. That's why we see an increasing number of programs.

Good for the company. After feasibility, we develop the process and we make the GMP manufacturing for Phase I or for Phase II.

The biggest increase we've seen is in the third category covering late-stage clinical, meaning Phase III activity, one late-stage program only in September 2023 versus five programs in September 2025. They are corresponding to BLA filing expected between the end of this year, Q4 2025 and the first half of 2026, which will clearly change the number of programs that we have in commercial for OXB next year. We see today that we are running two commercial programs versus one in September '23. That number is going to increase significantly as our clients' clinical data are extremely positive. And we're already discussing with them the capacity that they need for 2026 and beyond, even 2027 numbers are actively discussed at the moment.

Moving to Slide 12. That will be my last slide before I hand over to my colleague, Lucy. That explains the reason why we have raised GBP 60 million recently to strengthen our global CDMO network. They are strong CGT market fundamentals, as we've seen on my first slide. The number of programs keeps increasing and is increasing faster in the later stage of the activities.

We have the client demand and the pipeline continues to grow. And the U.S. situation is such that we need to continue to build infrastructure in U.S.A., not only for AAV that today is fueling the growth, but in the future for lenti vector manufacturing as well.

We listed very clear investment priorities. We want to continue that acceleration of revenue and margin improvement. We want to add commercial scale, GMP capacity in the U.S. That was the plan as of last year. It's still the plan this year, and we're working on the plan to make it happen very soon.

And last but not least, strengthen the global CDMO network so that we can deliver all vectors from everywhere and strengthen our competitive position in the global viral vector market.

Lucy, the stage is yours.

Thank you, Sebastien. So turning to Slide 14 now, please. So I'm delighted to be speaking to you today on OXB's H1 2025 financial performance. Now precisely a year into the role, I've gained a clear perspective on the strength of the business and the exceptional team behind it. Today's results underline that strength, delivering another strong set of numbers, which I'll take you through now.

Looking at the left-hand side of this slide, you'll see that we delivered exceptional growth in the first half of the year. Total revenues increased by 44% to GBP 73.2 million, a significant jump from the GBP 50.8 million in the first half of 2024. This builds on the positive momentum we saw in 2024, driven by strong demand from clients, including an increase in late-stage program activity.

This included strong revenues from GMP batch manufacturer, which saw an increase in the number of batches manufactured for clinical clients and for clients preparing for commercial launch. As a result, revenue generated from manufacturing services increased by 25% to GBP 34.4 million.

Development Services also delivered solid growth with revenues up 48% to GBP 28.5 million, supported by an increase in revenues from process characterization and validation work.

Focusing now on our commercial KPIs, which highlight continued momentum across the business. The contracted value of client orders signed during the first half of 2025 totaled approximately GBP 149 million compared to GBP 56 million for the 6 months ended 30th of June 2024. This includes signed orders with binding forecast from clients preparing for late-stage and commercial activities, representing more than half of orders and providing strong visibility for the remainder of 2025 through to early 2027.

The order book has continued to grow since the period end with total signed orders reaching GBP 190 million for the 8 months ended 31st of August. Revenue backlog was approximately GBP 222 million at the 30th of June, increasing to GBP 241 million by the end of August. This represents contracted future revenues from current orders and provides a strong indicator of client demand and revenue visibility.

We closed the period with a solid balance sheet, holding cash of GBP 53.9 million and GBP 17.1 million in net cash. As Frank and Sebastien highlighted, client demand continues to grow. And to meet this, we proactively strengthened our financial position post period through an approximately GBP 60 million equity placing and a new 4-year $125 million loan facility with Oaktree. This ensures we are well capitalized to support growth and deliver for our clients, particularly in the U.S. as set out by Sebastien earlier.

Turning to profitability. Operating EBITDA improved materially to a loss of GBP 8.3 million compared with a loss of GBP 20.3 million last year, driven by higher revenues and a continued focus on cost control. On a constant currency basis, the operating EBITDA loss would have been GBP 3.9 million. With an excellent start to 2025 and the progress we have continued to make, we are firmly on track for sustainable profitability for the full year 2025. Stronger revenues, disciplined cost management and the significant improvement in operating EBITDA performance position us for sustained growth through the rest of the year and reinforce confidence in our medium-term outlook.

Next, on Slide 15, I'd like to take a closer look at our cash position. As mentioned earlier, we closed the period with cash of GBP 53.9 million. Here, I'd like to mention again that we strengthened the balance sheet considerably post period with a circa GBP 60 million equity placing and a new 4-year loan facility of up to $125 million, taking us to a much improved cash position of GBP 113.7 million at the 31st of August.

Returning to H1 2025 cash flow movements. Operating cash outflow reduced significantly to GBP 4.8 million compared with GBP 48.6 million for the first half of 2024. This improvement was driven by stronger operating performance, disciplined cash management and enhanced working capital practices, including receipt of batch deposits and upfront client payments. We are now very well placed to fund strategic investments and deliver in line with client demand. The strengthened balance sheet and improved cash generation give us the financial flexibility to expand our global CDMO network and to execute on our medium-term growth plans.

Next, moving to Slide 16, our financial guidance, which was given at the time of announcing the placing in August, whereby we upgraded our medium-term guidance. Proceeds from the placing will support planned strategic investments to strengthen the group's global CDMO network and are expected to accelerate revenue and margin growth.

In the near term, for 2025, we expect revenues of GBP 160 million to GBP 170 million and low single-digit million pounds operating EBITDA profitability on a constant currency basis. For 2026, we expect revenues of GBP 220 million to GBP 240 million, representing circa 35% to 39% CAGR for 2023 to 2026.

Longer term, we expect to outperform the broader market with revenue growth of 25% to 30% year-on-year for 2027 and 2028. We will maintain cost discipline and expect margin expansion as capacity utilization builds, including strategic investments, we are targeting operating EBITDA margins of more than 10% in 2026 and at least 20% in 2027 with long-term potential to approach around 30% within 5 to 6 years.

Two factors underpin our confidence in this outlook. First, visibility. We ended June with a revenue backlog of about GBP 220 million, rising to GBP 241 million by the 31st of August. A high proportion of first half signed orders are backed by binding client forecasts. And for 2025, we already have over GBP 171 million of revenues covered by contracted orders compared to GBP 106 million at the same time last year.

The second factor underpinning our confidence is capacity and capability. Our planned investments, particularly in the U.S., are designed to come online in time to support late-stage and commercial programs, enhancing end-to-end service for existing and potential clients. This supports both top line growth and operating leverage.

On capital expenditure, we expect approximately GBP 60 million in aggregate across 2026 and 2027 before moving to steady-state CapEx of approximately GBP 20 million to GBP 25 million per year thereafter, deployed with discipline across our global network.

In summary, we have delivered another set of strong financial results. OXB's strong market position, rising client activity and a high-quality client portfolio, together with a strengthened balance sheet, provide a solid platform for sustainable growth in 2025 and beyond.

With that, I will now hand back to Frank.

Thank you, Lucy. Very impressive figures. Let's move to Slide 18, please. And before we go to our closing summary, let me take just a moment to remind you of the vision, mission and values that underpin our strategy and guide how we work at OXB.

Our vision is to transform lives through cell and gene therapies. Our mission is to enable our clients to deliver these therapies to patients, and our strategy is to lead the viral vector CDMO field as a trusted partner recognized for quality and innovation.

All this is based on our values, responsible, responsive, resilient and respect, the 4 Rs of our DNA, as we call them. They shape now how we work with one another, with our clients, and they have enabled us to deliver consistently in a complex and evolving sector to build long-term value for patients first, for our clients and for our shareholders.

Next slide, please. Turning now to the final slide. I want to leave you with a brief summary of our progress during the period and how we see the outlook for OXB. In the first half year, OXB delivered strong commercial and operational progress driven by sustained demand for our CDMO services across all vector types. While lentiviral programs remain the core of our clinical and commercial work, an increasing proportion of our contracts and clients' interest relate to AAV and other vector types, which broadens our growth potential.

With a strong order book and expanding pipeline and increasing number of cell and gene therapy molecules in development worldwide, we are confident in sustaining momentum in growing our client portfolio. And to meet this growing demand and deliver on our growth objectives, we have strengthened our balance sheet through the GBP 60 million placing and new loan facility, providing the flexibility to expand global manufacturing capabilities.

None of the significant progress we have outlined today would be possible without the unwavering commitment and resilience of the team working with us, whose expertise and energy continue to drive our success and help us deliver on our strategy.

As I draw this presentation to a close now, I want to reiterate that I'm confident that OXB is well positioned to deliver sustainable above-industry growth and long-term profitability. With good revenues visibility, we remain fully on track to reach EBITDA profitability in 2025 and achieve significant revenue growth consistent with our medium- and long-term guidance.

Now I would like to open the session to Q&A and take any questions you might have. So operator, please open the line.

[Operator Instructions] The first question today comes from the line of Charles Weston from RBC.

I have two, please. The first is just on visibility. It looks like you haven't the orders this year to effectively meet the top end of your range. So it's more about execution. I was wondering about 2026, though. You've got this revenue backlog of GBP 222 million at the half year with, say, GBP 90-or-so million to come out of that in the second half revenues. And then you've also been signing additional client orders. So I was just wondering if we can do some math on that and figure out roughly what proportion of 2026 revenues you already have covered in your orders?

And my second question, please, is just on the prepayments. There was a big step-up in H1. Clearly, that's going to unwind in 2026. But as you see more clients ordering commercial batches, perhaps others will do prepayments as well. So is that a sustainable step-up? Or should we model that unwinding in 2026?

Thank you, Charles. So why don't we start with sustainable -- the second question on sustainability of the orders, Sebastien, and then go into visibility.

Yes. Let's start with sustainability. We do not expect that our clients preparing for a commercial launch will decrease the volume that they need in '26 compared to '25, '27 compared to '26 and so on. So the sustainability is not a question of modeling. It's a question of forecasting, which for me is different. The model is based on assumption. The forecast is based on real data communicated by our clients, which are not assumptions. I mean, they are solid numbers of patients that they need to treat that are -- and this number is translated into a number of batches on which we need to execute.

So we have clear visibility on what they want to sign before the end of the year to make sure that it's executed next year. And as I mentioned during my presentation, we already have discussions about capacity needs for 2027, because when we're talking about future commercial products, there is a need to forecast to make sure that all patients are treated in a timely manner. So except major clinical issue at the very last minute that would completely change the positive view we have on their clinical data now, sustainability for me, I mean, I'm confident saying that this is sustainable.

It's also sustainable because, as indicated, we're growing in all the segments and not only as we were in the past only in the lentivector space, but today, lenti-AAV, MVA, adeno and so on. So considering that the pipeline value is not going down, but it's been going up as we've seen, I don't see any reason why it would not be sustainable.

Talking about mathematics, not something I'm going to be able to do today, because the figures you've seen here are the figures at the end of H1. And these figures have changed quite a lot. We're going to be at the end of Q3 in a week from now. So we've signed more. The only comment I will make is that we're confident enough in 2026 to start working on the plan for H2 '26 and H1 2027, meaning that we're actively working with our teams and with our HR business partners to build the people plan for execution in H1 2026. So we booked enough to be confident for next year.

Can I just -- sorry, just to clarify, the question I was asking was more about the sustainability of the prepayment. So should we just -- should we assume that as you get more launches, commercial preparation batches, you'll see further prepayments from customers?

We don't have anything in our contract that we call a prepayment. And each contract being unique, we have clients that are extremely prudent and we want to make sure that they have slots or suites reserved. So it's not a prepayment. It's a reservation, which is different. You don't prepay for the activity. You block capacity. It's a different mechanism. Not all the clients have this level of prudence. So I think that with the clients who have already made the decision to block capacity for the future years, that will continue. Some others want to continue looking at the last minute, facing situations where sometimes they don't access the slots that they wanted. I hope they will be more prudent in the future.

But if I look from a commercial perspective, and I'm sure that Lucy will be able to add on the financial side. But contractually speaking, I think it's wise for people going to commercial scale to have a reservation mechanism in place and make sure that they have no problem of supply.

Financially, I'll leave it to Lucy.

Yes, Charles, I mean, I suppose what you're asking here is around the contract liabilities. And I think based on our expectations looking into 2027, I think the answer is likely yes, in terms of the pure impact of what you're talking about, the balance sheet impact of contract liabilities or vis-a-vis the prepayments and our ability to sort of invoice more upfront as well from a cash perspective.

The next question comes from the line of Julie Simmonds from Panmure Liberum.

I was just wondering, you're talking more about, sort of, more and more about global market and global customers. Is the current footprint sufficient to do that, particularly looking at the proportion of customers from the Asian regions?

Sebastien, I believe that's a nice question to you. You'll like this question.

Absolutely. Yes, it's not that much about where the client is. It's about where we can execute for the project. In my experience, I mean, at OXB and even before OXB, most of the clients in Asia Pacific, to talk specifically about this geographical segment are actually quite happy having the activities run from Europe or from the U.S. depending on where they are in Asia.

The footprint as of today is sufficient to execute projects in the U.S., in U.K. and in France. We did not have specific demand for execution directly from Asia. There are countries and China is very well known for that, where it's in China for China. And that's the reason why we've not aggressively pursued opportunities in China, but for the other countries where we work, Japan, Korea, Australia and so, the network is sufficient today. And looking at the capacity we have left, it will be sufficient next year and even the year after, depending on how fast we grow, we may want to relook at the situation in 2028. But as of now, the infrastructure is largely sufficient.

The next question comes from the line of Christian Glennie from Stifel.

Just on the late-stage clinical programs you're working on, you said five today. Is it possible to say how many of those you already -- the company already has their late-stage clinical data in hand? And did you say that all five of those, obviously, barring successful development would expect to file by the first half of next year? That's the first question.

I think that three out of the five have clinical data, interim clinical data, not final yet. Yes, I think the right number is three. And I expect that three, potentially four will have filed before the end of H1 next year. Number five will probably be later in the year, probably Q4 next year, if not early 2027.

And then maybe, I mean, you've sort of hinted at this on the visibility. It sounds like you've got reasonable cover for '26, and you're talking into '27. But I guess just a bit more on your confidence on that 25% to 30% continuing through '27, through '28, just a bit more that underpins that sort of level of confidence, particularly in the sort of 28% range.

Sebastien?

Commercial projections. When people today work with us on the Phase III and they are interim data, keep in mind that the Phase III is going to be three batches for process validation. So when they plan 10, 20, sometimes 50 or above batches, we're talking about 5 years projection. So based on their projections, we built our guidance up to 2028. So yes, I mean, purely projections in number of patients and associated batches plus a continued growth of the market like we've seen over the past many years now. So yes, it's a simple mathematic exercise here.

Just to clarify, so largely of, what you -- the current programs and the current customers that's driving a large part of that even in '28?

Yes. I'm not talking just about the last category. I'm talking about all categories. We have -- we already have visibility on which Phase I are very successful and what they will want to do over the next years, plus indeed the late-stage activity that will move to the commercial space relatively soon, plus new programs. But that's -- for the new programs, it's based on the pipeline. So opportunities for the majority of the capacity utilization that we project for the future is based on existing programs that are with us today.

[Operator Instructions] The next question comes from the line of Zain Ebrahim from JPMorgan.

This is Zain Ebrahim from JPMorgan. My first question is just, I think you said that some of the new clients, I think 100% of the new clients are AAV. So just if you could remind us what percentage of the business at the moment is AAV. And I think in the space in general, we've seen cases of acute liver failure from some companies. So just to remind us why -- what differentiates your AAV platform from the likes of Sarepta would be helpful. Just as the first question.

Sebastien?

Yes. First, I'm going to start with something that I think we must keep in mind. AAV is not one vector like lenti. There is indeed one lenti, but there are multiple AAV, AAV2, AAV5, AAV8, AAV9. So when we're talking about Sarepta, we're talking about one AAV serotype in one indication. The market is not Sarepta. Sarepta is not the market. Sarepta is one indication in the middle of tens of indications.

We see a fantastic progress in the ophthalmology space, for example. These vectors have nothing to do with the Sarepta vectors. So I understand the question around AAV. I think that what we should discuss should be AAVs. Because that's where we make sure that in our pipeline and in our portfolio of ongoing program, we've diversified the program to make sure that we're not in the situation where we're exposed to one type of vector only. We don't do just AAV9. We do all the AAVs.

And the team has experience on 12 different serotypes at the moment, if I remember properly, the numbers that we discussed recently over more than 10 different indications. Again, Sarepta is one serotype in one indication. So we're not different from the other CDMOs in that.

I know that Sarepta is making the headlines, but there are many companies that are not making the headlines and progressing very nicely in the AAV space, including for muscular dystrophy, including with serotypes, either wild-type or modified capsid that show less toxicity than others. And that's part of the technical data that we're discussing with our clients. We see multiple AAVs progressing well without any associated toxicity.

And I think that's, I mean, quite well understood by the scientific community on why some serotypes have more toxicity than others and that there is still a need to select better the serotypes, including modifying the capsid in some cases to work with hybrid capsids.

I said 100% of the new clients indeed were AAV in H1, which doesn't mean that we didn't sign lenti programs, but the lenti programs were not coming from new clients. They were coming from existing clients. I just want to clarify that we signed contracts in all the different spaces, but the new contracts were AAV. Only that reflects the growth that we continue to see in the AAV space.

How much in percentage, Lucy will correct me if I'm wrong, but I don't think we've ever disclosed how much business we were doing by Vector segment.

That's very helpful. One other question would just be on the 2025 guidance. So you said that you've got GBP 171 million of coverage for revenues this year, where your guidance is GBP 160 million to GBP 170 million. So just to help us understand the range in the guide that you've maintained today given that the contracted value does seem to suggest that you could maybe deliver towards the upper end?

Lucy?

So clearly, our guidance is subject to revenue performance obligations. And in short, Zain, it would be remiss of us not to take into account some element of operational execution risk.

There are no further questions. So I hand you back over to Dr. Frank Mathias to conclude today's conference.

Thank you so much. So this indeed brings us to the end of our today's presentation. I want to thank all of you for your time today. We appreciate your continued support and look forward to keeping you updated on our progress throughout the rest of the year and beyond. Thank you so much. Have a good rest of the day.