Oxford Biomedica plc (LON:OXB)
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Earnings Call: H2 2022

Apr 25, 2023

Frank Mathias
CEO, Oxford Biomedica

Hello everyone, and thank you for joining our meeting today, our analyst report, meeting 20 on the results of 2022. I'm Frank Mathias. I'm the newly appointed Chief Executive Officer of the company, and believe me, it's a great pleasure to meet you today, together with our Chief Financial Officer, Stuart Paynter. I believe you all know him. Yeah. Just for those who do not know me by now, I'm French, as you can hear from my accent, I'm sure about that. I was born in Paris, and I went to school there and to the university. I'm pharmacist by education with a PhD in immunology and more than 30- years now of experience in the biopharmaceutical environment, in senior positions at different companies throughout the biopharmaceutical industry.

As you might know, I come from another renowned CDMO, namely Rentschler Biopharma, where I was CEO for about seven years. Also I've only started three weeks ago, to be very precise, three weeks, one and a half days ago. I can already say following, and this is in line with what I have expected from the beginning. Being a scientist myself, I'm really impressed by the science at Oxford Biomedica, the science behind the team, behind you, Kyri, because we are happy also to have in the room today our Chief Scientific Officer. Our company is already recognized as a true leader in the innovative development and production of viral vectors, and this applies mainly for lentiviral vectors, as you know, but I believe that we are also making big progress in the AAV field.

Our client base is constantly, and Stuart will report on that, expanding and now includes more than 30 partners around the world. 30 partner programs, to be precise, around the world. With a few feedbacks I got already from clients who work with us, I can guarantee you that they're extremely satisfied with us and with our service. On the other side, as a leader, I'm equally impressed by the high level of commitment, professionalism, and quality of the Oxford Biomedica team, and I have met by now both teams on both sides of the ocean, here in Oxford, but also in Bedford, near Boston. We have a clear vision to become a leading global innovative partner for cell and gene therapies, not to say the leader.

I firmly therefore believe that we are at the heart of the next generation of medical breakthroughs. I'm delighted to be part of the next chapter together with the team of this story. There are so many opportunities in the market. There are a great demand for our know-how and our service. On the top, as a quality and innovation-led CDMO, and the D in CDMO stands for innovation and development, we will continue to combine research and development activities with market needs to deliver the highest possible quality in a timely and cost-effective manner. I'm now going to hand over to you, Stuart, to start the presentation and talk about the year in review. After the presentations, there will be enough time to take your questions. We'll be around if you want to speak more to anyone who has time to stay.

We have a live webcast running currently. For those joining us remotely, please ask plenty of questions when we turn to you. We are accepting written questions, that's nice, if you prefer that route. Our Investor Relations team, Taylor Boyd and Sophia Bolhassan, will come back to you in this case. As said, our Chief Scientific Officer, Kyriacos Mitrophanous, is also with us today. You all know him. I'm sure you appreciate him as I do. Please go ahead.

Stuart Paynter
CFO, Oxford Biomedica

Thank you very much, Frank. I'm gonna take you through the presentation. I'm gonna attempt to do that in about 25- minutes to leave some sufficient time for Q&A at the end, as Frank mentioned. Actually, as we look up at the first slide, which is the covering slide, actually tells a bit of a story because, you know, part of the impact that Frank's had in Oxford Biomedica in the three weeks, one and a half days he's been here, is he's added a one word in the front page, and that's to increase our focus on quality.

For those of you with good memories, we were saying that we were an innovation-led CDMO, and now we are saying that innovation and quality will hold sort of equal rights on the sort of title page for this company. We'll go through a bit about why that is and what that means in the presentation. Forward-looking statements, you all know this. FY 2022, this is just a snapshot of some of the achievements in the year, and we'll go on to a bit more of the strategy in a minute.

obviously the single biggest achievement of the year was the transformative acquisition that we made at the beginning of 2022, which closed in March 2022 of Oxford Biomedica Solutions, which I'll remind you is the carve-out of the technical capabilities of Homology Medicines, a Nasdaq-listed company, into essentially a startup CDMO. We acquired the assets, the equipment, a nice facility, 130 individuals with really, really good experience in the AAV field, the IP, which has gone on actually in the year with the published data we've put out to really prove itself, and then the contract with Homology for exclusive rights to produce and work on their portfolio of medicines, which is ongoing.

That was our first move into the, into the adjacency of AAV, which we'll take you through the reasons why a bit later. We've increased the client base within Oxford Biomedica, so 13 new client relationships in the year in both Lenti and AAV, another three post-period end. It's really good momentum and we'll take you through a bit of the thinking around how we're morphing into more of a commercial entity with strong commercial capabilities, which we're continuing to invest in. The robust financial position in this environment, we know that cash is super important, and we'll take you through some of the reasons why we think we're in a really, really good spot to exercise that cash position to make the best use of any opportunities that come our way.

Of course, as Frank Mathias has told you, all important that we get the right leadership in place to drive the new story. We'll, we'll talk a bit about how we're bifurcating the business into this quality and innovation-led CDMO in one sense, the internal products in the other, and how we're going forward with that. I know Kyri's here potentially to answer any questions you have on that. You know, what remains with Oxford Biomedica from 20, you know, beyond 2023 is gonna be this quality and innovation at CDMO, and we're very happy to welcome Frank Mathias to lead the organization. Why do we think we can win? This is the sort of value proposition. What do clients value? They value, our ability to solve their problems.

Biologics, especially cell and gene therapy, is still, you know, a tricky business to be in, high barriers to entry. If you can provide really, really top-quality products and top-quality service, and you can provide the right level of innovation and innovative solutions to your partners, you're gonna be in a very, very nice position. We firmly believe viral vectors continue, are playing and will continue to play a key role in this next wave of breakthroughs in medicines. These are curative therapies. We're seeing some really nice momentum in the marketplace now, more and more approvals, which of course is gonna increase the market size, and we expect to be able to rise significantly with that tide. We've got this proven track record.

We were the first on the market with the cell therapy, the first cell therapy approved in the U.S., Kymriah with Novartis back in 2017. We've had an unbroken record of market supply since, and that cannot be said for every cell and gene therapy that's been launched since that time. We've learnt an awful lot from that relationship, and we've been able to transfer that learning into the other clients' relationships and really leverage that know-how and build that know-how state. These capabilities. We were, a year ago, we were a Lenti company, and that's a great place to be. We were, and we are the leading Lenti company. Now we've made that leap into that sensible adjacency, bigger market, faster-growing market, and we'll tell you some of the reasons why we've done that.

Here is the market. This is the addressable market for viral vectors, and when we talk in addressable markets, we're talking about the outsourced bioprocessing revenues available in these markets. AAV is the biggest market, and it's the fastest-growing market. The move into AAV was a very sensible, very pragmatic one, and we're very excited by it. The reason it's so much bigger is the quantity of vector required for a dose is just higher. You're going systemically into the patient rather than typically the way that Lentis have been used and what's reflected in these market sizes is ex vivo therapy that occurs outside the body where you need less vector.

We do see in vivo applications for lentiviral vectors as we move forward with the future generations of Lenti and again, we're just about to launch fourth generation Lenti, and Kyri can answer some questions about that if there are any. That's super important because that enables more modalities to be tapped. At the bottom, not such a fast-growing market, in fact, declining as you can see there because the growth or the size of that market is very dependent on the adeno vaccine that was the AstraZeneca COVID vaccine. Not strategic for us, but we do have capabilities and if the right client comes along with the right proposition, we're happy to work on that area for them.

You know, more opportunistic, but of course, you know, in the world of a CDMO, you need to be both strategic and opportunistic to make sure you build the right mix of clients in the right stage of development. Just a quick view of the timeline of 2022 and the achievements. Cabaletta Bio signed in January, innovative CAR- T company in the U.S. March, I've taken you through the closing of Oxford Biomedica Solutions. We've got this plug and play platform, and maybe this is the time just to go through a bit on that. I mean, we are quoting titers of 1E15. full-to-empty capsid ratio is 90%-ish plus. You know, these are market leading sort of KPIs for these platforms. You know, this is published data now.

You know, we're really excited to bring that to market, and they've done a great job so far. As well as supporting Homology, the lead client, you know, they've signed multiple new clients onto the platform early stage, but they're really transforming themselves into this, you know, top-level AAV CDMO. July was extension of the contract with Juno BMS. We're hoping to be able to talk more about that very soon. Another undisclosed and a master services agreement with AstraZeneca, which although it's there for as a safety net for AstraZeneca for us to produce whatever they need, I think it's an endorsement of our capabilities 'cause of the 11 or 12 people they had in their supply chain for the vaccine.

You know, we're the ones with the enduring relationship with AstraZeneca, which is a good indicator of the level of service we gave AstraZeneca during that, the vaccine production. In August, we finished the fill finish suite in Oxbox phase I. Vitally important because we want to be able to offer a genuine end-to-end solution for our clients. Right from cell line development and process development all the way through to fill finish, now we can do that all in-house. You know, we were using outsourced fill finish, which comes with its own issues, but now we are full service CDMO, which is fantastic progress. A new client for Oxford Biomedica Solutions in September, as well as an undisclosed client in Oxford and another three clients in December.

Whilst you see all these are undisclosed, let me just take you through a bit of the reasoning why. We're seeing some undisclosed clients at the moment because firstly, if they're early stage and they're in funding rounds, they're in stealth mode. Secondly, if they're coming from another CDMO, it's a difficult thing to manage moving CDMOs. Of course, we're very willing to respect the process of our clients. You know, we're not in this for the short-term gain of throwing up a name in a press release. We're in this for, you know, the long term of helping these clients get their products to patients. Just a bit on the financial performance. Double-digit growth in the underlying revenue. You'll see that the revenues were broadly flat.

We have taken off, you know, GBP 40 million worth of, or within those numbers is GBP 40 million of vaccines revenue. That has now come to an end, as we know. We're expecting next year's number to be slightly lower, but that's with double-digit growth in the underlying business. A modest EBITDA profit, of course, with us driven by some other, you know, clever use of assets that we made. The sale and leaseback was an important aspect of generating cash and a robust cash position as well as earnings. You know, we have, as we said, the sale and leaseback there, a profit of GBP 21.4 million. The Oxford Biomedica Solutions acquisition, we saw the expenses go up as we're supporting a nascent CDMO.

It's an investment we know we were making. We said we're gonna break even on that asset by 2025. That's still the plan, it requires some investment in that area. You know, we're in a position where we can support that investment through a robust cash position, which I'll take you through. Highest cash position we've ever had at the end of the year, GBP 140 million, supported by, like I say, the sale and leaseback, GBP 60 million coming from the sale and leaseback of the Windrush facility, with Kadans, who are a great science partner to have on the sale and leaseback. They're really active in the Oxford area and looking to increase the scope of lab space all around the Oxford area. Very good. We took a loan to complete the Oxford Biomedica Solutions deal.

We repaid GBP 35 million of that GBP 85 million loan in September, refinanced with a competitive refinancing process. Now we've GBP 50 million in a four year term loan, which is up for renewal, comes to maturity in 2026. Importantly for the external products that which we're working on, we've said that we're bifurcating those two parts of the business, very important for us. Become apparent to us through the year that, and in fact in prior years, that it's very difficult to support those two competing demands for resources in a sensible way under one roof and one set of investors. There is some fantastic technology there we're looking to give life to. The plan there is to, by the end of the year, have the no P&L movement through on the products.

They're gonna be out with a life of their own with external funding, which we're gonna retain a long-term economic interest in. Of course, importantly, they're gonna be a potential customer or a customer of Oxford Biomedica as we start them off with process development and all the rest of the activities which we would give any other client at arm's length. That's a really important thing that we're gonna do in 2023, and that allows us to re-segment the business and in 2023 at the interim and guide further.

We have gone through a right-sizing project towards the end of the year, which we've made sure that we have retained the cost infrastructure and the capability infrastructure to make sure that we're well-placed to exploit the growth in the end of 2023 and 2024 and beyond, where the real takeoff of cell and gene therapy is gonna occur. We're gonna make sure we guide in that way. You know, post the vaccine coming to an end, we made, you know, judicious but sensible adjustments to the cost base to make sure that's reflected. Reflected lack of revenue from the vaccine, but a cost base in place to make sure that we're in a good place to exploit the growth opportunities we find in front of us. A little graphical view of that. As you can see, this is six month segments.

You know, what we told people is while we're waiting for cell and gene therapy to mature, we'll roughly be break even, and that's what we've achieved in this year and in prior years. You'll see that profitability spike coming from the vaccine. That taught us a very valuable lesson, which Frank already knew, which is that if you can produce at scale, and you can campaign assets on a large enough scale, you're gonna make some very, very meaningful efficiency gains, and you're gonna generate some good EBITDA. You know, that's where we will focus our efforts on getting a balanced customer portfolio going forward, not just early stage, but some later stage assets as well in order that we can start building those efficiencies through the capacity that we're running.

The revenue growth, there's some significant vaccines revenue in there, of course, but the underlying growth is strong at double-digit. Like I say, interims will be guiding further over the medium to long term on how we see revenues going. Okay, for the accountants in the room, here's a P&L. Not much to comment on this. I'm sure that there'll be questions. The most interesting number on there that I think is probably the bioprocessing costs line. The bioprocessing costs line is significantly increased because you can see how much bioprocessing costs you can absorb through overhead absorption when you're running 24/7, three suites on the vaccine.

That vaccine, you know, that vaccine was done point in time for the good of the nation and with the efforts of AstraZeneca and Oxford University. That's the promise of what you can achieve when there are more launched products and commercial products to go for on the higher throughput volumes. That's what we're aiming for. The commitment to quality and focused on innovation. How are we gonna make our money going forward? How are we gonna serve our clients going forward? How are we gonna try and pick up clients going forward? Frank was making the point earlier that we need to find the clients that are right for us. The clients that value both quality and innovation and are prepared to share that economic benefit with you.

This is the way that we're gonna engage with those clients. We start at the early stage, cell line and process development, where we've got those commercial development revenues are starting. This is vitally important. They'll take a license to the platform, they come onto the platform, they're able to utilize our analytics, all the rest of those things that give people a bit of a leg up and a bit of a boost forward in terms of their time to R&D. Then we go through pilot scale, early stage clinical, late stage, and then commercial and fill finish. You can see there how we see the revenues changing. Of course, as you get closer to commercial and into commercial, the bioprocessing revenues, the revenues you produce for the materials go up and up and up.

Of course, well, where someone's taken a license to that platform, the royalties start flowing as well. We're also looking, like I said, at where we can add clients in at every stage on this particular chart, because if someone wants to come in and again, they're the sort of customer we value, you know, tech transfers would be available, and that's something we're actively pursuing with our new commercial team. Just a word on the commercial team. We've had our Chief Commercial Officer, Sébastien Ribault, in place for since October, and that's a significant investment we're making at Oxford Biomedica. We're moving from five or six people in that team to mid-teens people in that team this calendar year.

We're doing that because we see a massive opportunity in terms of brand recognition and the commercial model we're trying to roll out here with this newly bifurcated focused business to really make a big difference in terms of the pipeline and pipeline conversion into new customers. This is just a snapshot over that five year period. You can see how much progress we've made. Five years ago, just under GBP 40 million in revenue. This year, GBP 114 in revenue. Look at the clients and how we've expanded that. There's some great names there. You'll note, we were asked a question earlier, how many clients do you lose? You'll see that Orchard and Novartis remain. Bioverativ were acquired by Sanofi, who deprioritized the product, and Immune Design got acquired.

We have a fairly unblemished record at the moment of no one's left us for other CDMOs. The quality of the customer service we bring is really strong, and we're aiming to continue that with our Net Promoter Score, which we measure and which is very, very impressive. A few bits on Kymriah and, you know, where we are in terms of developing our own products. Of course, now we've bifurcated this business, we're now a focused quality and innovation-led CDMO.

Probably the biggest achievement is the facilities development in that time period, where we've gone from essentially Windrush Court, for those of you who have visited us, and a couple of small, sort of GMP suites in various locations and single-use GMP suites in warehouses to a world-class facility in OxBox, where we've got four suites up and running. Fully funded second half of development there for suites up to 2,000 liters and of course, 90,000 sq ft in Boston, just outside, well, in Bedford, just outside Boston, in terms of AAV development and production. Here's a little bit on what partners want and where we're innovating. You know, typically, why would a partner come to us?

Those partners that value innovation and quality, they're looking to leverage the expertise we have, the platform technologies we have, the fact that we can be flexible. We talk a lot about competition, and we pride ourselves on being very agile as the size of business we are. That's very important because we're competing against some really, really big players. We can just be more agile, we can give a more personalized approach, and we can help solve problems in a more active way. That's a really, really key part of the offering to our partners. Those technical capabilities we've talked about. We've talked about the full-to-empty capsid ratios, titer in the U.S. In the U.K., we've got, you know, a very, very long history. Looking at Kyri now, 25- years in our business as a Chief Scientific Officer.

You know, we've been at Lenti making quality product definitely the longest. You know, it's now time to make sure that's leveraged in terms of how we can bring clients on. You can see the progress we've made. Novartis, Juno, the what two of the three originators of the CAR- T technologies are with us. You know, we're always speaking to some of the big players. Where are we focusing innovation? We focus innovation on anything that will make the process more robust, safer, higher titers and yields, better quality. It'll get people through feasibility studies much quicker and obviously safety. That's what the focus is around the new process, Process C, which uses perfusion technology.

There's an efficiency gain there, a mechanical efficiency gain, plus some of the add-ons that we're putting in there, the biological add-ons, U1, U2, which will increase titer and yield. Then, 4th generation Lenti, which is encompassing quite a lot of this stuff, which is gonna form the backbone and the platform for people as an offering now, and should give them the best chance of success when they're developing their product with Oxford Biomedica. This is a super important slide, and we'll continue this. This replaces the old slide where we used to name the customers and the products. We're sort of clumping them together a little bit because, you know, the important thing here is these are, these four development stages in which we're looking to add clients.

You can really gauge how we're progressing through the number of new client programs or projects we're working on with clients. Obviously, it's great to catch them early because they come onto our platform, and they'll be there for the long term. It's also good to catch them as they're approaching BLA, and they're looking for commercial solutions or potentially, as the industry matures, even second-source supply contracts. We need to be super flexible as a CDMO should be, and we need to add all the way along this list, and we need to progress from the top to the bottom, as well as adding just sheer numbers, volume numbers to this, to this chart. This is gonna be a key performance indicator for us going forward, how we're adding here.

The pipeline that we've got, that Sebastian and his team are generating now is looking extremely healthy. you know, we're hoping to sign, you know, new meaningful contracts this year, which are gonna bolster these numbers. The financial outlook, and we're coming towards the end, is strong double-digit growth in the underlying business. We expect the total revenues to be marginally lower than 2022 in 2023 because GBP 40 million of the vaccine revenue is coming off. That's still really, really good underlying growth. We've right-sized that cost base. We're making some interesting investments in the first half of this calendar year in terms of scalability and digitization, which is being led by our Chief Information Officer.

You know, we're expecting an EBITDA loss as we are carrying that cost base, which is gonna see us through this growth in 2024. This is a choice, this is a strategic choice we've made. We're prepared to carry this cost until we see the pipeline come through and the ramp-up in 2024 and beyond because, you know, this is a choice we made after a lot of discussion. We don't want to cut too deep into the cost base and then have to re-put back that cost base and retrain people. This is the right cost base at the right time. We'll go through why we think we're in the right place at the right time in a moment.

CapEx level is very similar, and of course, that does encompass the first bits of building of Oxbox phase 2, and looking to diversify that pipeline, execute on that pipeline, and give the commercial team all the support they need to make sure they're closing great customers, great clients who are aligned to our offerings of innovation and quality and are willing to share those economic benefits with us. This is the last slide before we just put it onto the holding slide. Opportunity for us. I just used that phrase, right place, right time. You know, we genuinely are hearing some really encouraging noises coming out of the industry on the number of approvals coming forward, how biotechs and companies are gonna engage with CDMOs going forward to give them the best benefit.

We think we're in a fantastic place to do that, being a platform technology company. We've got this track record, we've got this vector-agnostic multi sort of stranded offering, and, you know, we genuinely, with our increased focus now, we are a focused, quality-driven, innovation-driven CDMO. We're in a great position to make sure we're actualizing that potential of the market. Of course, you know, the market's gonna rise. We'll rise with that market, but we also wanna beat the competition and make sure we increase share, keep on increasing the number of new clients, and make sure those clients that are with us get a great quality experience all the way through and give their products the best chance of winning and eventually getting to patients. That's where we are. I'm looking at you for closing remarks.

Frank Mathias
CEO, Oxford Biomedica

I've said enough. I should close. From the discussion I think we just have, we... I hope that you can value that the company is currently in a very good starting position for addressing the needs of the cell and gene therapy market for the future. There's a big demand for outsourcing. There's a big demand for cell and gene therapies. We are covering AAV, we are covering Lenti, we are covering Adenovirus. We are looking at additional formats for the future. We are doing everything to grow our positioning, grow our position also in the market. Having said that, thank you so much for your interest in the company. You should continue to look at us. Thank you.

Stuart Paynter
CFO, Oxford Biomedica

Thank you very much.

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