Oxford Biomedica
2023 Preliminary Results
Audio Webcast
29th April 2024
Transcript
Disclaimer
This transcript is derived from a recording of the event. Every possible effort has been made to transcribe accurately. However, neither Oxford Biomedica nor BRR Media Limited shall be liable for any inaccuracies, errors, or omissions.
Dr. Frank Mathias: | Thank you so much for joining today's analyst briefing for our '23 Preliminary |
results. I'm Frank Mathias, the CEO of Oxford Biomedica and it's a pleasure to | |
see so many familiar faces here in this room, so thank you for coming, to be | |
here to speak to those on the webcast and those joining via the conference call | |
lines today. | |
With me, I have our Chief Financial Officer, Stuart Paynter, our Chief | |
Commercial Officer, Dr. Sébastien Ribault, and I'm also proud for the first time | |
to have, joining me, Thierry Cournez, our relatively new appointed Chief | |
Operating Officer who is also in charge of the UK operations. As I believe that | |
you have all met Stuart and Sébastien before, I will let Thierry introduce himself | |
when he starts his section of the presentation shortly. | |
So, looking at 2023, it's obvious that '23 was a year of transformation for Oxford | |
Biomedica as we began building a global pure play cell and gene therapy CDMO. | |
Throughout the year we have met significant milestones and celebrated many | |
successes, which have provided me and the board with confidence in our new | |
strategy and its ability to deliver long-term sustainable growth. I will begin this | |
presentation by highlighting these achievements and the progress we have | |
made to transform the company before handing over to Thierry to discuss the | |
integration and transformation of our global operations in greater detail. | |
Sébastien will then provide an update on the strong momentum we are seeing | |
on the commercial side, and Stuart finally will give an overview of our financial | |
performance for the year and also a midterm outlook. | |
As you know at the core at Oxford Biomedica, we have a mission to enable our | |
clients to deliver life-changing therapies to patients. This mission underpins the | |
incredibly important work we do. The strategy that we are implementing is | |
geared towards helping us achieving this by providing best-in-class CDMO | |
practices and accelerating the time it takes to our clients to bring the treatment | |
to the market. | |
I will return to a slide we showed in September last year for our interim | |
presentation when we announced our three-pillar plan. As you will soon hear, | |
we are progressing through the plan to deliver long-term sustainable growth | |
and have moved into the implementation phase now delivering on what we had | |
promised last year. | |
In the last year we took important steps towards our vision of becoming a global | |
pure play, world-leading CDMO in cell and gene therapies increasing our | |
geographical footprint into now three geographies - UK, US, and recently the | |
European Union, re-organising and aligning our operation and streamlining our | |
structure. The ongoing transformation will provide us with a multi-vector, multi- | |
site model giving us a platform to better serve our clients through offering | |
greater flexibility while benefiting from synergies at the same time. |
As part of our move to multi-vector,multi-site model, we have made significant progress in transferring our lentiviral vector capabilities into our Bedford site near Boston, US. The first production runs were initiated in February this year. We delivered the five-litrescaled-down model process and accompanying analytics at the end of March already.
In January this year, we were delighted to announce that we had acquired ABL Europe from Institut Mérieux in France. This extremely important strategic acquisition increases access to EU-based clients and broadens our international development, manufacturing and testing presence and further increases our capacity in process and analytic development as well as early-stage manufacturing.
The addition of the two sites in France adds approximately 150 CDMO experts to the group, as well as additional vector types to our client offering. It also positions us well to seize further opportunities in the fast-growing cell and gene therapy sector. For aligning our footprint in the UK, the US and EU, we have put in place our new One OXB strategy to harmonise and optimise our operations so that we can benefit from increased efficiency and agility.
The transformation of the company into a pure play CDMO is allowing us to scale up our operations globally while maintaining high standards of quality and innovation. As part of our evolution, we have implemented extensive cost management initiatives and refined our structure. By doing so, we laid the foundation for sustainable growth and profitability while leveraging our expertise in viral vector manufacturing.
As a quality and innovation-led CDMO, we are committed to reducing cost per dose and accelerating clinical development, thus expanding patient's access to life-changing therapies. Our latest innovation, the TetraVectra™ system, is a prime example of this. Launched in May 2023, this fourth-generation lentiviral vector delivery system allows for higher-quality viral vectors with higher potency and safety that enables cells and gene therapy companies to overcome previous barriers in therapeutic development.
As a result of all these activities, we are already seeing the first successes of the new strategy demonstrated in 2023 by a 51% increase in the business development pipeline and the 54% growth in the client order value as shown on this slide. These successes give me full confidence in the medium-term guidance we have provided, which is supported by strong KPIs for the year to date. This includes 31% growth in the business development pipeline, which now stands at $573 million and growth in the number of clients and client programmes to 35% and 51%, up from 18% and 34% respectively as reported in April last year.
Furthermore, we saw an increase in the number of late stage and commercial programmes from two to five. This increase in the number of clients and programmes has led to an 11% growth in revenue backlog for the year to date which stood now at £104 million at the end of March. I would like to note that
this figure excludes a new order with a US client preparing for commercial | |
launch, which we announced in March recently. | |
As you can see, we made and continue to make immense progress, and I would | |
also like to highlight that a lot of this progress has been made since September | |
last year, so in the last six to seven months. Also, it allows me to reiterate the | |
guidance communicated to the market recently. We expected full year 2024 | |
revenues to grow by 40% to 50% over last year and to achieve broadly | |
breakeven in 2024, as mentioned before. | |
I will now hand over to Thierry to discuss our One OXB transformation and | |
integration work stream. Thierry. | |
Thierry Cournez: | Thank you, Frank. Thierry Cournez, I'm the Chief Operating Officer for Oxford |
Biomedica. I'm also the Site Head for the UK site. I joined the company last | |
October after 27 years in a large company organisation in the pharmaceutical | |
industry with different experience in sales, marketing and operations. I'm | |
pleased to be here with you today. | |
As Frank highlighted, we have a new strategy to become One OXB. We have laid | |
on different initiative, and we focus on six strategic pillars to integrate and | |
transform the company. Within these six strategic pillars, we have structured 20 | |
work streams globally aligned with different experts from the different | |
geographies, which focus on leading the transformation of the organisation to | |
become a pure play CDMO with a global network. | |
This slide is illustrating the strategy of some of the examples which can explain | |
the advancement that we take in transforming the organisation. We focus first | |
on the quality of our people and experts in the organisations. We want this | |
company to get one company culture with the same values. We want to | |
become a workplace for a CDMO expert to join and drive the clients' projects. | |
We focus as well on becoming a client-centric organisation as a pure play CDMO | |
focusing on executions, high-quality delivery. We have worked on looking at our | |
efficiency and how we organise to ensure that we increase resource allocation | |
on client projects. We have developed strong activities toward our CDMO | |
services in our portfolio, refining our go-to-market strategy and intensifying our | |
marketing efforts and brand recognition to be seen as a global CDMO player in | |
the cell and gene therapy space. | |
In terms of increasing the revenue and increasing the returns, we look at | |
streamlining our processes, ensuring efficiency gain and implementing site- | |
based structures in the three geographies in the US, in the UK and France. | |
Last but not least, we continue to invest in innovations, making sure that our | |
innovation roadmap is focusing on the client needs to accelerate the pipeline | |
and to reduce our cost. I will now hand over to Sébastien. |
Dr. Sébastien Ribault: Thank you, Thierry. The initiatives that were described by Thierry have four objectives to help the company grow and take on more projects. Why do we need to take more projects? Because the market is growing, as we see here on this slide.
The company had been known for a long time as a lentivirus-only company, and with the acquisition of our site in Bedford about two years ago, we are now delivering routinely AAV and lentiviruses. There was also an experience with the AstraZeneca COVID vaccine in developing adenovirus-based vaccine. That's why we continue to focus on the adenovirus market as well.
If we're looking at the market as it is today, we're shy of a $3 billion market size with a growth that is estimated between 2024 and 2028 of about 20% year-on- year to reach almost six billion in 2028. Interestingly, the three key segments that we're serving, AAVs, lenti, and adeno keep growing and not only do they grow in US and in Europe, but they also grow in Asia. That is the reason why we wanted to make sure we would have enough capacity to serve the clients wherever they are. That drove the acquisition of the site in Bedford, Massachusetts, that also drove the acquisition of the two sites in Lyon and in Strasbourg. We've seen the FDA and EMA and other regulatory agencies in the world approving new programmes, meaning that the maturity of that space is increasing.
We continue to see a shift that started some years ago from treatment to cure and the perception of the standard treatment is shifting as well. So cell and gene therapy was a fourth line of treatment, became a third line of treatment, and some of the recent ones have been approved as a second line of treatment as well. More programmes, but also more capacity needed as we're serving more and more patients. The biotech funding situation is still difficult, but difficult if you are at early stage in a very small company. We've also seen some of our mature to very mature accounts being well funded and that's the reason why as we'll see later on this deck, we've been able to progress significantly projects and programmes that were at late stage and will very soon be at the manufacturing stage.
We have a healthy mix of clients today, as I said, serving AAV, lenti and adenoviruses, but also other vectors. I will not list everything here. If we start by looking at the volume of contracts, the difference between 2022, excluding COVID, and 2023 is about 54%. If we're looking at the number of contracts that we've signed in percentage here compared to the market, on the market about 4% of the project are coming from the big pharma. About 20% of the new project we've signed in 2023 are coming from the same big pharma. We see that if the market is about 24% with the established biotech well-funded, it corresponds to 23% of the new contracts that we've signed in 2023. 72% of the market is with emerging biotech and that corresponded to 57% of the new contract that we've signed.
We made sure that the portfolio was well-balanced to avoid the issues linked to funding. The more early stage you go, the more emerging biotech you go, the more issues you will find. The more you go towards emerging biotech and big pharma, the less funding issues you will have. You will also find by far less project with the established biotech and the big pharma. That's why the portfolio needs to be well-balanced.
Talking about the balance, you can also compare on the right side of the slide the markets to the vectors that we're delivering to our clients. As I said, the company was very well known during many years as a lenti only company, and that's why still today about 50% of the projects that we're delivering are lenti projects. If you think about 2022 when the company was not known at all for being an AAV player, we've literally moved from zero to 41% of the projects being AAV. So, our clients have well understood that the track record we had in lenti, the quality level that we have on lenti that could be replicated with AAV, and that's why we've seen a very strong growth in the AAV space in 2023.
Adeno, as I said, we had the experience with the AstraZeneca COVID vaccine. We continue to serve clients who have adeno projects, whether we're talking about oncolytic viruses or more simple adeno type project. Last but not least, I mentioned that we're delivering on other vectors. As you see, it's about 3% of our portfolio and I anticipate that it'll continue through 2024.
We've seen a significant growth of the orders, but before the orders, we have the pipeline of opportunities. We've seen quite strong growth between '22 and '23 moving from $291 million to $438. If you look at the first number that we can disclose now in 2024, it's at $573 million, which means that between 2022 and today, we've pretty much doubled the size of the pipeline. We've expanded the number of vectors that we're offering to clients. We've expanded the number of clients, we've expanded the number of programmes per existing clients as well, and we've grown the pipeline in Europe, where back in 2022, the vast majority of our clients were US based. We now have a much better balance between Europe, who's at about 30% of our overall pipeline versus US.
Frank mentioned during his introduction, the launch of TetraVecta™, part of our lenti vector platform. We've also launched an AAV platform, inAAVate™ that you see here, and there will be some more news coming through 2024. We continue to capitalise on existing technology. We continue to innovate and we continue to be ambitious about being recognised as an innovation and quality CDMO.
The number of late-stage and commercial programmes are growing. As any CDMO, we want a well-balanced portfolio of active programmes. We had a number of clients at early stage, now we have a more balanced portfolio of clients with about 46 projects as of April 2024 being between pre-clinical and phase two. Three of these programmes are late-stage, meaning phase three. For two of these programmes we have commercial agreements, meaning that we're either already producing for a commercial product or preparing for the
commercial launch of a new product, that is giving us a total of 51 to be | |
compared to 28 as of 2022. We're now serving clients, as you can see from the | |
logo at the bottom of the page on many different types of vectors as it was | |
planned when we spoke about a year ago. | |
It was important to grow the capacity. It was important to add some new | |
capabilities. It was also important to give access to our clients who want to be | |
next to our process development scientists, analytical development scientists or | |
GMP teams when the activities happen in our plants, which was one of the | |
drivers of the acquisition of the two new sites in Lyon and Strasbourg that we | |
acquired from ABL Europe. So the geographical location was one of the drivers. | |
Increasing the number of vectors that we can deliver was another one of these | |
drivers. You see here some examples listed of vectors that we inherit from ABL. | |
The last driver was to be able, as I said earlier, to deliver for all geographies and | |
obviously having now two sites in continental Europe is giving us the | |
opportunity to deliver in Europe for Europe, but also deliver for some of our | |
APAC customers who wanted to have a delivery site in Europe when they want | |
either to target the European market or minimise the time difference with, for | |
example, the US when they are historically working with the US CDMOs. So, | |
we'll continue to strengthen our commercial efforts to fill these capacities, and | |
Thierry already demonstrated that the integration effort is ongoing to make One | |
OXB out of these three geographies. I'm going to now hand over to Stuart for | |
the financial part. | |
Stuart Paynter: | Thank you, Sébastien. Good afternoon to everyone. So I'm going to take you |
through three slides, the first one is a review of 2023, the second one looks at | |
near term guidance in 2024, and the last is a distillation of what Sébastien was | |
talking about in terms of our position within this market and our growth | |
opportunity over the next two to three years, which as you'll see is very exciting. | |
So for 2023, first thing to say about both the revenue and the costs is that when | |
we guided in September, we've come out more or less spot on where we | |
guided. So revenues at the end of 2023 of just a shy under £90 billion compared | |
to 2022 of £140 with a number greater than £40 million in the vaccine revenues | |
in 2022, which were non-recurring. In the underlying piece of the business, | |
there was a very modest growth. So we really consider this to be the baseline | |
revenue that we're currently at £90 million. | |
Unfortunately, that was supporting a much bigger cost base. So if we go onto | |
pillar number two here, the cost base supported meant that we made an | |
EBITDA loss of £52 million in the year, which obviously is unsustainable, and we | |
took actions throughout the year to make sure that we were rebasing those to | |
both give us a launch pad for '24 and beyond in terms of delivering the growth | |
and being able to do the transformation programmes, which Thierry outlined | |
new ways of working and becoming a pure play CDMO. That exercise generated | |
a sort of perpetualised £30 million of savings, which we completed the project | |
in the second half of 2023, and we'll see those benefits coming forward. |
Below the line, there was an impairment of £99 million. It's just worth reflecting on that, we take this very seriously. We reflect on the deal that we did in 2022 for Oxford Biomedica Solutions, as was part of Homology that we bought, and there were four value pillars to that deal. There was the equipment, the people, and the expertise, the technology and the contract with Homology themselves. The first three of those pillars are forming the backbone of our strategy, so the facilities which are world-class facilities in Boston in the right place for our clients, more than a hundred people with significant AAV expertise, which we're adding to our offering to the clients which Sébastien talked about, and the technology itself, which has proven in patients in the AAV world.
The last one was a binary risk that we knew we were taking with Homology themselves on a contract, which is guaranteed for 12 months. That has now crystallised in terms of losing the contract with Homology leading to this level of impairment. So we still think that it's a highly strategic deal for us in terms of the first three pillars, but unfortunately the risk crystallised on the single customer risk that we knew we were taking on at the time. So a one-off impairment spread across multiple asset classes, but that's where we are for 2023.
At the end of 2023, we've got an extremely strong balance sheet. So we've got cash balance of more than a hundred million pounds. We believe with the plans that have been laid out and we will lay out in the next few slides, we are well- placed from a cash perspective to see ourselves through the transformation period, through One OXB to the growth and ultimately to self-sustainability and cash generation.
What gives us that confidence? Well, Sébastien has already outlined a few of these numbers, but in pillar four here we look at the KPIs, the early barometers of what we think is our success for the next few years. We already know that the orders have grown, the orders significantly grew from about £85 million to £130 million in 2023. Of course, that's going to flow through to revenue over time, and also the revenue backlog is growing very nicely from £95 million [correction: £94 million] at the end of the year, £94 million to £104 million at the end of March, not including the sizeable deal we signed in March and led to orders in April. We are in a really good spot in terms of predictability and visibility for delivery in '24 and '25. And that gives us the confidence to really push forward and be able to guide in what we think is an accurate and exciting way.
Just looking at '24, we are reiterating the guidance, as Frank said. We expect the revenues in 2024 to be between £126 and £134 million. That's a 40% to 50% growth of the baseline FY23. Broadly breakeven in the underlying business, that's excluding France, which closed in February this year. And with France a modest EBITDA loss. We expect France to be a modest EBITDA loss this year, but that's fully funded from the way we did the deal with cash injections from Institut Mérieux.
CapEx will be limited so we are looking at particularly strategic initiatives, things | |
like transferring of platforms from one location to the other. We are really, | |
really well set from a CapEx perspective. We've made significant investments, as | |
people know, in the last few years, including Oxbox and other things, and we've | |
got a really nice infrastructure base to support the growth out to about 2028. | |
No big infrastructural investments in things like GMP suites until that time. | |
We've got some human resources to play around with to make sure we can | |
deliver for our clients, but nothing big in terms of CapEx. And we're on track to | |
achieve that medium term profitability in 2025 and then beyond because we've | |
made this commitment. We've made this commitment for the medium term to | |
2026, and we've said, and we are reiterating here, 35% revenue CAGR, including | |
France now. You can see what that means to that chart. | |
And you'll remember what Sébastien said about the market as well, we are | |
looking to significantly beat the market in terms of growth. We believe we've | |
got great visibility, a great client roster to be able to do that and take advantage | |
of this maturing industry with no further huge CapEx investments required to at | |
least double our revenues and beyond to '28. And that's really, really exciting | |
and this is going to be high quality revenue streams coming through in the next | |
few years. | |
That's going to lead in the year 2026 to an operating EBITDA margin of greater | |
than 20%. We know that the journey does not stop there, we know that the | |
best-in-class CDMOs in our area making 30%, but that's going to take a few | |
years for us to again build the scale to be able to do that, but you can see there | |
the list of the reasons why we believe this is a true possibility. Because when | |
you think about it, we are sitting on this infrastructure. We can more than | |
double the revenues into that infrastructure and that's going to really drive the | |
EBITDA growth in the business. | |
With the visibility we have and with the opportunities ahead of us, we think this | |
is a very deliverable plan and we're fully committed to it. And I'll hand back to | |
Frank. | |
Dr. Frank Mathias: | Thank you so much, Stuart, and thank you so much also for the outlook. For the |
remainder of 2024, we continue to execute on our new strategy and focus will | |
turn to integrating all sites to fully create as Thierry has shown, one OXB, a | |
united company alongside growing our global portfolio of clients and | |
programmes. | |
This slide shows us our flywheel, which is a nice summary of our strategy. | |
Central to everything at OXB is our employees. Our employees are the most | |
valuable assets and are crucial for us to be able to operate a client-centric | |
organisation and to deliver excellent client experience. This will in turn lead to | |
expanded client partnerships, as we already see, will attract new clients as we | |
already also see. Will generate increasing revenues, will allow us to invest to |
serve our clients and so on. It's a typical flywheel so the ultimate goal is to get | |
the flywheel to turn on its own. | |
While we have made significant progress, it is important to note that the | |
numbers obviously we are presenting are backward looking. But as CEO, I have | |
to look forward, and as you have seen in the presentation, we reiterate the | |
guidance for this year. The share price may not currently reflect the progress | |
made by OXB throughout the year. However, we are confident, the team here is | |
confident, the Board is confident that we are on the right trajectory and that | |
our efforts and performance will be recognised in due course. | |
Before we open the room for questions, I would like to take this opportunity | |
also to thank our employees for their hard work and contributions as well as | |
their ability to embrace change. And there is a lot of change currently, both now | |
and in the future. That dedication and hard work has been instrumental in our | |
transformation in achieving the many successes along the way. We'll now be | |
pleased to take the questions from those in the room and Sophia will bring a | |
microphone, before we take questions then from the conference call line. | |
Sophia, please. There's one question from Charles. | |
Charles Weston: | This is Charles Weston from RBC. Thanks for taking the questions. Three, please. |
The first is on the revenue backlog, you've provided an April update on the | |
business development backlog, but you've only given us a March update for the | |
revenue backlog, and I know you said you've signed this big contract. | |
Presumably not going to give us the number, but can you give us an order of | |
magnitude of a potential increase? Are we talking 20%, 50%? What's the broad | |
uplift that we should be looking for? | |
Stuart Paynter: | Charles, we can't calculate the backlog because we need to calculate the April |
revenues to put into the backlog. It's a formulaic calculation, it's an auditable | |
number. Backlog plus orders, less revenue equals closing backlog. We haven't | |
done bit that. We can't until we're in April, and as Sébastien said, I think that's a | |
good word, significant. We can't give any more details now. They will come in | |
due course. As you know, we're committed to the communication plan of being | |
far more frequent into the market now and give more frequent updates on our | |
progress in terms of trading updates, and you'll see that when we do our next | |
trading update. | |
Charles Weston: | Okay. It was worth a go. Secondly, on network utilisation, obviously you've got a |
lot of capacity as Stuart was talking about, and relatively lower utilisation at the | |
moment. Can you give us a sense of what is your percentage capacity utilisation, | |
where we stand today? And what I'm obviously trying to drive out there is what | |
full looks like from a revenue generating capacity within the current network | |
without any more meaningful CapEx. | |
Dr. Frank Mathias: | Yes. Capacity has different components in terms of infrastructure, resources, |
equipment. Right now, we do have the capacity to deliver on the GMP batches, | |
which are planned for making our numbers this year. France and the US site give |
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Oxford BioMedica plc published this content on 08 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 May 2024 09:16:01 UTC.