Oxford Biomedica plc

And welcome to UXB 2025 preliminary results. We are joined today by Dr. Frank Mathias, Chief Executive Officer, Dr. Lucinda Crabtree, Chief Financial Officer, and Dr. Sebastian Brebold, Chief Business Officer. If you would like to ask a question during today's call, please press star 1 on your telephone keypad, or you can submit a written question via the toolbar below. 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 US and good afternoon to everyone else and thank you for joining our OXB preliminary results briefing for the full year of 2025. Presenting alongside, as I just mentioned, with me today is our Chief Financial Officer, Dr. Lucy Crabtree, as well as our Chief Business Officer, Dr. Sebastian. Next slide, please. Before we begin, sorry, one back, yeah, sorry. Before we begin, I will quickly run through today's meeting agenda as seen now on the screen. We'll begin with a business update, providing an overview of OXP'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 Sebastian 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's financial performance in 2025 before handing back to me for closing remarks and to open up the call for questions. I would like to start by highlighting some of the key financial results from what has been an outstanding year for OXP. 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 £170.9 million. This represents an almost 90% increase in revenues since full year 2023, when we stood at around £90 million. This growth reflects a 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 204% million and the contracted value of client orders increased in the same period by 20% to 224 million pounds, 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 three years ago. We delivered operating EBITDA profit of 8.1 million pounds at constant currency, compared with a loss of 15.3 million in 2024. Finally, the group ended the year with 96.9 million pounds 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 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 analytics with our ambitions, medium and long-term targets as we enter 2026. 2025 was, as said, an exceptional year for AXP 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 £60 million fundraising alongside a new loan facility from OCTRI. 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 vial vector manufacturing facility in Durham, North Carolina, U.S. As the integration process continues, 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 Scripps after the end of the period. This agreement covers lentiviral manufacturing for multiple CAR-T programs and reflects the maturation of our client's pipeline, as well as the growing number of programs progressing towards later stage development and commercialization. It also reinforces OXP'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, multi-site strategy. This includes the ongoing transfer of our AAV and lentivial vector platforms to France, where lentivial 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. These milestones 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 number six, 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 decline in 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 three times 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 biovector manufacturing site in Durham, North Carolina. With its integrated drug substance and field 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 US manufacturing footprint. It allowed us to avoid the time, cost and risk of building from scratch and move quickly to meet client and market needs. Localizing our supply chain in the U.S. also offers attractive tax incentives and enables 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 AV patch 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 UK, US and France, positioning us close to our clients. In 2025, supported by our 60 million Pounds equity placing, we strengthen our integrated global network further through targeted strategic investment across all sides. 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 OAXP'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 biovector 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 OXP 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 Sébastien, who will provide an update on our commercial performance and pipeline, as well as the wider market conditions that drive our business forward. Sébastien.

Thank you, Franck. 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 three segments that will generate the growth over the next six 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 AEV that we'll discuss in the segment number two. We have available platforms on the market and the track record today across multiple vector types including lentiviruses, adenos, MVA 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 markets 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 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 cap seeds on empty cap seed 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 AEDs 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 two plasmids instead of three with the 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 UK. 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 UK, but also from the US. 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 U.S. with EMEA, in Europe with EMA, or in Asia with multiple agencies already working with us on our existing and commercial products. Moving to the next slide we're going to see OSB's position today in the markets as you see based on our calculation and global data with the data published in January 2026 were number four in the viral vector CDMO market today and if I look at the three companies that you see at the top of the graph Two of these companies had a volume of business that did not grow as fast as OXB last year. We're actually two of the top four with a very nice growth and we've seen that the two 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 three 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 next slide, you can note that our network of sites today has changed the way we're perceived in the markets. We're not only a UK 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 three quarters, 72% were for UK and 18% for our US site in Detroit. Fast forward 12 months, Q1 2026 on the right side of this graph, The share of UK is now below 50%, 46%, and we've increased very significantly the number of opportunities that can be handled by the French side, moving from 10% to 23%. I'm going to start 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 US or if we're doing the development and the manufacturing in UK 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. Better 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 a positioning for OSB 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 the US sites will continue to go up as we're feeling this capacity. Individual, you see the splits by geography for 2025. For those who were on the same call about two years ago, the European component was very small in the 10 each percent, where today at 40%. plus 7% in APAC and U.S. relatively stable 50% of the opportunities. I think that the APAC segments in which we invest through more business development activities or through licensing deals like the one we recently signed with DVMF, the APAC segments 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 204 million pounds, which means that we have a lot of confidence for 2026, that we will hit our revenue target as we have 204 million pounds 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 correct, just 2026, but also part of 2027. Very happy to report as well that the orders finished at £224 million, meaning £4 million above the corporate targets that we had set at £220 million. Very strong order intake, a backlog that has grown at the pace that we expect for the company, meaning 30 plus persons, 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, then you contract, the pipeline goes down. It's not an opportunity anymore. It becomes a contract. 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 signs and the 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 AV space than landing. Oxford Biomedica was known as a Lenti company. We moved to multi-vector with the 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 two, the phase three 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 one 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 one, two, three 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 have five programs. In 2025, that became six programs. We're today at eight programs. We expect that one of them will become commercial this year at least, probably two, and another two 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 their logos at the bottom, some of them being obviously new. But as I 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 segments 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. Lucie, I'll hand over to you.