Oxford Biomedica plc

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. Sébastien Ribault, Chief Business Officer. There will be a Q&A session following the presentation, and if you'd like to ask a question, please signal by pressing star 1 on your keypad. We ask that please limit your questions to just one with a follow-up, if necessary. I would now like to hand the call over to Dr. Franck 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 Cretry, 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, Sébastien Ribaud, 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 OXP's positions as a leading global cell and gene therapy CDMO. I will then hand over to Sébastien to provide an update on our strong commercial performance, and then Lucie 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, Roman Youth continued to grow in the first half of the year, increasing by 44% to 73.2 million pounds. Meanwhile, contracted clients' order grew by 166 year-on-year to 149 million pounds, 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 £12 million to £8.3 million for the period, compared to a loss of over £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 UK, US, 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-size 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 UK, additional antivirus 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 100 million US dollars and an equity placement of 60 million pounds, in this case, post-period in August. We will strategically invest this added financial flexibility to strengthen our CDMO network globally, including commercial-stage AED 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 sustainable growth and profitability. Next slide, please. The reason OXP 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 patches, 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 always 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 factor CDMO network, strategically located across leading biotech hubs in the UK, US, and France. This footprint not only places us close to our clients in the end markets, but also provides resilience against tariffs, pressures, regulatory shifts, and other external headwinds by balancing capacity across regions. As mentioned earlier, we raised 60 million pounds to strengthen this network. We found to be directed towards expanding our USAV 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 Sébastien, who will provide an update on our commercial pipeline and the market dynamics that continue to support our business. Please, Sébastien.

Thank you, Frank. Good morning, good afternoon, everyone. We can move directly to slide number eight and talk about the market situation to start. up to preregistration are increased. The most impressive, at least for me, is to look at the last three categories, the phase two, the phase three, and the preregistration. The phase two programs have moved from slightly shy of 280 to 330, which means an additional 50 programs in phase two for cell and gene therapy. Likewise, phase 30 is moving from 34 to 45, and preregistration from 5 to 13. 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 are for us through phase one, through phase two, and they are now either entering phase three or being at pre-registration. 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. So, it was difficult in the case of Oxford-Bayern handicaps to talk about CGT 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. XenCell Pro from Excel Terra is a cell therapy program only that doesn't trigger viral vectors. Still, the trends. directly applicable to the OMB business. And if we move to slide number nine, the growth of the market is the same growth that we enjoy when we look at the overall value for Oxford Biomedica. Starting on the left side of the slide, we have signed 56 million pounds of orders at the end of H1 last year, and we have signed 149 million pounds 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 tried 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 listed here the lengthy pipeline in pink. the AD pipeline in green, and all other vectors in dark blue. At the end of H1 2024, the pipeline was around $570 million. We added on top what we had signed at the end of H1, since the pipeline variations are due to what enters new opportunities, but also what exits the pipeline, meaning the order we signed. If there are orders, there are not any more opportunities. 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 stayed in the pipeline at the end of H1, plus what we had signed, was giving us a value of $732 million, plus 13% compared to last year. that plus 14% compared to what we had seen on the previous slide, which was 7% year-on-year growth of all the programs, accumulating preclinical phase 1, 2, 3, and registration, shows that OXB is growing across markets. 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 OXV has a value, and that's the reason why LAMC remains a key driver of our pipeline today, although the AUV value is significantly increased from 91 million last year to 100 million this year. Moving now to slide number 10. It illustrates how the OXV strategy has an impact on the type of contract that we sign. Our clients are happy with OXV. 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 we'll see in one of the next slides, 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 is not pictured on the slide here, but in age one, 100% of the contracts from new clients were AAV contracts. That reflects the strong roles we have seen in the pipeline, but also the fact that OAV is not seen only as a LENC company now, but as a LENC and AAV and other vectors companies, as we have defined it in the one-way . 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 three 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 technical 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 2020. What does that mean? It means that many of our clients who were at feasibility stage have progressed into phase one and stayed with us. That's why we see an increasing number of programs. Good for the company. After feasibility, we developed the process and we made the GMP manufacturing for phase one and also phase two. The biggest increase we've seen is in the third category covering late stage clinical in phase three activity. one stage program only in September 2023 versus five programs in September 2025. They are corresponding to VLA 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 or 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 16 million pounds recently to strengthen our global CDMO network. There are strong CDT 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 activity. We are 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 AED that today is fueling the growth, but in the future for LAMC vector manufacturing as well. 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 out of last year. It's still the plan this year, and we're working on a 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 all-vector market. Lucy, the stage is yours.