Great. Well, good morning, everyone, and thank you for joining us. My name is Matt De La Torre, and I'm a biopharma analyst here at Goldman Sachs, and we're very pleased to continue the next session this morning with Alvatec, where I'm joined by Robert Westman, founder and executive chairman, and Balaji Prasad, chief strategy officer. Robert and Balaji, thank you for being here. Thank you for listening. Thanks for inviting me. Maybe to start, Robert, before we get into specific programs, and I know you guys had an announcement this morning, and you made a big announcement last week. Maybe just, you know, for those of us less familiar with Alvo, you know, give us a brief overview of the company, and then, you know, frame for us where you all stand today, you know, kind of like your key priorities, and how you're thinking about the outlook and strategy over, you know, the next couple of years.

It's a very good question. And, yeah, so I founded the company 2013. and the vision has been building up pure-play biosimilars, not focusing on anything else. We wanted to build end-to-end R&D in-house from satellite development to developed BLAs. We wanted also to have all the manufacturing in-house. Those two elements were always critical to us because it's a fairly complex product to develop, And those are also very complex to manufacture, to have it all in-house. So we have invested in R&D and manufacturing close to $2 billion since we started 2013. And the company went commercial for the first time in U.S. mid-2024. So the company is fairly young on the market. But we have been building all the infrastructure. and what we have is a portfolio of 30 products, which we believe is the broadest portfolio in the industry, if you will. We have launched five products outside the U.S. We have two products on the market in the U.S. And by later this year, or late this year, we expect to launch another three products into the U.S. And then, of course, a few of the submissions we will talk about, I'm sure. Super exciting. And our aim is always to be in the first wave or be first to market. And we have all the infrastructure now which we can engage. We have commercial partners which are covering more or less every market in the world. So we can roll out our products into 80, 90 markets and compete with the brand. So holistically, it's all coming nicely together, and the company is at a massive inflection point, we believe, now after we resubmitted the three BLAs into the U.S.

Great. Yeah, maybe kind of diving into those resubmissions last week and some of the news this morning. You guys made a pretty material announcement last week that you've resubmitted your BLAs for Biosimilars, Symponi and ILEA. I think many people were expecting this closer to the end of the month. So maybe this came a little earlier than we all expected. Maybe walk us through how you got here and kind of how significant this is for you all.

Yeah, I mean, we are operating globally. So we basically, currently our facility is approved by all major regulatory health authorities in the world, including USFDA. It was unfortunate that we got a CRL in the first round of the three pipeline products. There was no comments on the BLAs themselves, but there were some comments on the facility. We have, of course, worked over 10 months in details to fix what we felt we needed to fix to make sure that we would not be in a position again to receive a CRL. So a lot of work has gone into that. We resubmitted last week. By a similar little symphony, we are the first and the only one in Europe. We have launched now with our partner in Europe. We are seeing a very strong uptake in market share. We are up to 40% in some of the markets. We have seen strong market uptake in Germany and Scandinavia and elsewhere. We have one competitor which we believe will launch in Europe one day, and the same one might launch into the U.S. But we think we are in the first wave, potentially still first to market with Biosimulator Symfony in the U.S. And then we are launching ILEA, Biasimla to ILEA, and then ProLIA XGIVA. So that will drive the growth of the business next year and going forward, but more importantly, the submissions and the filing acceptance by FDA on Tivio is really, really a big milestone for us.

And Matt, so I think on the question that you said, right, that most investors are expecting this towards the end of the month and now, I think it was also because, you know, we had this FTA inspection last month, which we cleared very successfully. And so investors were wondering if because of that we will be pushed out beyond June 2. And we are very happy to assure our investors that the observations that we had, few observations were manageable. And more importantly, the FDA also went through a lot of very comprehensively and that we are filing it on time in June, in the first week of June, signals that the inspections were really solid. And that's why the market also reacted the way it did and has more confidence in us now. And today's news on ABT-16 was like an icing on the cake. So really important to note that.

Great. Yeah. Could you maybe remind us a little bit about what you implemented were, and then can you talk about any kind of safeguards that are in place now to prevent any kind of similar issues?

Yeah, maybe. So basically when you go through an inspection, you answer the 43s, and then FDA sends you a PAL letter stating what they felt they're missing to basically approve your new filings. There were three main issues there. First was the rubber stopper in our syrances. So we have a German-made machine from Bosnian Straubel, which I think every second sterile manufacturer has. So this machine requires a pharmaceutical-grade silicone to lubricate when you start to operate the machine, especially with the rubber stopper so the flow through the machine FDA didn't like that I think this might be a new theme and we are most likely the first one receive that one but how that ended is that we managed in the end after stopping for a couple of weeks to operate the machine without any lubrication so that was our answer to that we are of course new in the market As I said, in the U.S., we had complaints in the U.S. over 500, 600 auto injectors. At that time, we had produced 5 million, which proportionally is very small. But the overall FDA wanted us to tighten up the process, how we follow up to receive some of the faulty pen back. because in the U.S., as you might know, if you dial into your pharmacy, you claim that your pen is false, you get a new one. And the patients are not often giving the pens back, which in the end we need to investigate. But we believe we have, both internally and with the case itself, so far as Vek Ovi, and it's from Ipsomed in Switzerland, and we have not had any mechanical issue with the pen, to be honest. And then when it comes to the third point, which is general environmental monitoring, we had hits in the facility all below action limits, which means that they are not critical enough to be above action limits. But still, we wanted to have fewer of them. And collectively, we have implemented over 200 KBAs to fix that. And we submitted, resubmitted with three months data where we did not have any hits anywhere, even though we are looking at only below action limits. So I think we have addressed the fundamental, of course, what was pending, but more important, the fundamental of this facility. So I think we have gone over and above simply to make sure that we are not going to end up in a similar situation with the CRL.

Great. And then your biosimilar Prolia and X-Jiva, I think they were not included with this resubmission. What are your kind of expectations in terms of timelines for filing?

Sure. Sure. So Prolia and Giva is the marketing, the authorization is with Dr. Redis, our partner. So in the U.S., for most parts, we are partnered with Teva, and this one is with Redis. And so they will be filing, which will be imminent.

Maybe lastly on the Symphonium and ILEA, you know, the FDA just completed, I think, a routine CGMP surveillance inspection at Reykjavik. I guess, how do you view the likelihood of another re-inspection?

Yeah, it's an interesting question. So basically, we believe that FDA went through all the open items from the PAL letter. We did not get any comments or outstandings on the BLA itself. So technically, they would not have to come, But we know that FDA has their own agenda. But what we have said, it doesn't really matter to us if they come or not. We are ready to receive FDA, and we would just welcome them if they come. But they could also decide not to come. But it's a six-month clock. We expect that FDA generally is using the six months, so it's early December, which allows us to lump the three products into USB for year-end.

Maybe shifting over to the Antivio update this morning, you guys had a big announcement there. Maybe you kind of just walk us through the update, and then you recently submitted an MAA to the EMA for the biosimilar in Europe. I guess, how are you thinking about the opportunity in both Europe and as well as the U.S.?

So this is something that we're really excited about. We are very happy that the submission and the acceptance of it came through. And it's one of our most important near-term to medium-term opportunities that we have discussed about in the past. For context, the global market size of this is pretty large. It's around $7 billion and has a sizable market in the U.S. And we expect to be in not just one of the first market, but also going to be a limited competition for quite a while. So we are really happy to have this around and, of course, set the clock for a 12-month approval timeline from the date of submission, right? So it could be one of our critical launches that we'll be looking forward in the near term itself.

Yeah, I just want to underline what Balaji said. I mean, we have their $7.5 billion opportunity. We believe there is only one developer which is close to us. We are not aware of anyone which has submitted. We have also the SAP Q version of the product, which is important. So all in all, we believe that for most markets, this will be announced next year for us. And so I want to underline what Balasi said. I mean, we are super excited about this opportunity. And this is by far the biggest opportunity in our short history of being commercial, which is coming up.

You know, and you touched on this a bit, but, you know, I guess in that context, how are you thinking about the opportunity for, you know, Symphoni, ILEA, low dose, and Prolia X-Jiva?

Yeah, I mean, overall, I think Symphoni, us being alone, of course, outside the U.S. still today, it's being shown to be a good opportunity and being either first or one of two in the US will also be very exciting but again Symfony is around $3 billion product so just from size perspective Antibio most likely will be even more exciting if you will we think with Lotus ILEA there is still a strong market for the product and we think we will be in a good position I mean we know that Amgen has been super successful in the US and we have launched the product now into UK with a pretty strong market share just in a couple of months over 5% and we have rolled out the product into European Union, so excited about that. Probably Xtiva, we have always seen as more competitive, and that product was one of our first ones to develop, so we ended finishing it, but from gross profit, gross margin, I think for everyone it will be more competitive to the other two.

And in terms of market opportunity on both of these, So I think investors also tied up the fact that we didn't get to the market at the end of Q4.25, as we were taught. But the commercial opportunity of both of these, especially Symfony and Ilia, they're very much intact. Because most of the settlements are towards Q4.2026 or Q1.2027, and we'll be coming in with the next wave of launches. So the Ilia commercial opportunity, even if it had gotten approval last year, would still be very much the same and intact. And with Symfony, again, there's only one other filer who got approved a couple of weeks ago, and they have stated that they will be launching in Q4 2026, which with the resubmission that we announced last week, we expect to basically be in the first wave, if not the first to market with Symfony still. So the commercial opportunity is something which is very much intact and which clearly the market misread or misunderstood the situation there. So that's, again, I think important to highlight, Matt.

Great, yeah. And then maybe kind of in the context of low-dose ILEA, and I think you guys are also pursuing high-dose ILEA. How are you thinking about kind of those timelines and that relative opportunity?

Yeah, so I think Alba Tech has been one of the pioneers to adjust to the changes of the brands. so we were the first to adopt from low dose to high dose on biosimilar to Humira and we went into Antibio with a subcube when we saw the brand going there we also when we saw that Regeneron was gonna launch a high dose 8 mg we basically internally before the product came to market we made five, six prototypes in-house. And when the product then launched, one of our formulation was a perfect formulation from both MADS and the IP standpoint. So we always expected to be in the lead. We have seen 40% conversion in Europe, 40% conversion in the U.S., and that conversion, we believe will continue and we saw that Amgen announced that they are starting their clinicals for US in June and we have already been working on our clinical so we should be ahead of them in US and we are pretty imminently filing already into the rest of the world markets with the product And what is also interesting is that the safety device or the Ocuclid which they have been developing, we have spent two years on a similar device. So I think we will be in an absolutely pulled position when it comes to Heidel Sahlia. I'm super excited about that.

In terms of timing?

We will be submitting in the rest of the world this year. And I would not rule out that that could be a launch on approval. We are then finishing the clinicals for the U.S. market, so we will be submitting a bit later there.

And in terms of launch timing for U.S., do you have any clarity on that?

I would not comment on that until our clinical is done, if you will.

What we have said, though, is that it's one of our medium-term opportunities, and so definitely think about it in that time frame that we are really excited about and as a clear differentiator for us.

And then maybe moving to another kind of mega blockbuster, Keytruda. Obviously, very competitive market, but you guys recently, I think, you guys have a partnership with Dr. Reddy there. Or, I guess, really kind of walk us through the strategy for that molecule.

Yeah, I mean, it was kind of, as we all know, it's the biggest molecule in the world. In our mind, we wanted to have it in our pipeline to be able to offer it to our clients. But knowing also how many companies were developing the product, It, in many ways, was not commercially as lucrative as it would be with the last competition. So we were kind of early adopter of stop doing the patient study or phase three study already. We expected that we could skip the patient study for K-truda, which brought the cost substantially down. And then this is a co-development with Dr. Redis, where they will be, in the end, producing the drug substance. So we are sharing the cost. We believe we will be more cost-comparative than most others. So that's kind of the approach we did to be in the product. But overall, I think it will be a pretty competitive molecule going forward.

Maybe switching over to business development, you all recently announced a partnership with Fujifilm Biotech. It expands your global manufacturing network and, I guess, establishes a second source of commercial supply in both the U.S. and the U.K. Maybe can you elaborate on what drove the rationale for that deal?

Yeah, so it's a very good question. So we have one facility in Iceland. It's a state-of-the-art, both drug substance, drug product, with a capacity we have set beyond 2030. We have, though, five products on the market. We have 30 products in the pipeline, which we believe, again, is the strongest pipeline in the industry. When we saw the patient study would be not needed going forward over two years ago, we increased the capacity in cell line development, process development, and where we felt we had bottlenecks. So we have been on the cadence starting new R&D program almost every second month for over two years. So when it comes to the capacity, we are seeing three launches in the US end of this year. Mm-hmm. We are seeing that we are growing markets here substantially outside the U.S., especially for biosimilar to Symfony. We are seeing our good colleagues here, Teva, growing the shares in both biosimilar to Humira and Stellara, which is nice to see. And then on top of that, we will be expecting to launch and TIVIO into multiple markets. And this will all come into a very similar time frame. It will all happen, of course, throughout next year. So having Fujifilm as a partner, which mainly is working with Big Pharma, was something very valuable to us and will allow us to be more flexible in case we gain more market share. if the order from our clients come in in the same quarter to be able to still deliver on that. So it was very strategic and long-term. But, of course, we will be using our own facility at the same time fully.

So we should think about it. It will be used for both commercial and pipeline products. Fuji, yeah. Absolutely. Maybe kind of stepping back and looking at the biosimilar market a little more broadly, you know, obviously the opportunity over the next decade is very significant, and kind of things have been changed. Regulatory-wise, you touched on some of the FDA changes, and then we've also seen changes on the payer side with private labels and things. I guess how do you guys kind of internally, you know, strategize and kind of think about the category overall in that context?

Yeah, I think if we start at the beginning, because it's a fairly young industry, if you will, as you know. So we saw quite a few players coming in at the beginning. And it was the same. I mean, I was the pioneer in the generic industry since 1999. I built ActaVis, AlvoG, and quite a number of generic companies. And we are starting a new era with biosimilars, as we did 26 years ago, in January, if you will. And it's only five, six years since really adoption in the U.S. and market share gain started to happen for biosimilars. We know those products are very effective, but very costly. We are seeing the trend now that 40% of the $1.8 trillion pharma market is biologics. We are seeing in phase two, phase three, from the top ten big pharma companies is biologics. So basically, we think we will see the trend from 40% to 50% and even 60% going forward. At the same time, the early adopters, some of them are leaving the scene, if you will. We have seen Böhringer Ingelheim. We have seen Pfizer. And we have seen others which are scaling down. One could say it's cheaper now to develop biosimilars. And the answer is yes. It does cost still $60 million to $90 million per product. And you need to build a facility which costs you half a billion at least. So it's a billion-dollar venture before you get really into it and usually take 10 years. So I'm not seeing necessarily, even though the regulations are changing a bit, that we will see a flood of new players coming in. So all in all, I mean, this is a company like ours is really needed just to sustain healthcare systems around the world. We have the pipeline to basically grow and support markets in U.S. and Europe and where it is globally. So overall, I mean, we are extremely excited about our journey, which in many ways commercially is just starting.

Yeah, and I think it's also important to note that though there's the CES waiver, the FDA may say, okay, CES waiver, but they're going to increase their scrutiny on all of the data that we submit to our companies. And that really plays well for companies like us with a very strong R&D track record, a very strong process and analytical data capability to be able to showcase that. And this is not something that can be acquired by any new entrant overnight. So that really forms a moat to the industry and forms an entry barrier. That's something that we think that, especially some of the top incumbents like us, it helps for us to grow and capitalize into this explosive growth period in biosimilars that is coming up over the next 10 years now.

And maybe how do you think in terms of how we'll actually see it play out with, you know, not requiring the phase threes? Do you, I mean, clearly some companies are still running phase threes, and, you know, if you read the FDA guidance, it's like, you know, make an argument for why you don't need it. So do you all imagine it will be essentially no one will be running Phase 3s in a few years, or it will be dependent on how?

I think it will be very exceptional if Phase 3 will be run going forward. And you need to have the analytical data to support that your product is interchangeable. and we have seen if you pass the PK the phase 3 was not really adding anything into the development that's why we expected this to come and this to happen and that's why we adopted to it earlier than anyone else and then you asked about the market dynamics private labels like in US that's a US thing it mainly applies to retail products which are pharmacy benefits we had Humira of course being the biggest one there are not too many pharmacy retail benefit products coming out so we are not really seeing the private label necessarily playing a big role going forward It did in Humira, with a different success between the three PPMs. But overall, we think it will still be, especially when you have product more medical benefit, it will still be, you know, some of the smaller ones, both smaller PPMs and promotions and providing a quality product to the market, which will count. Opportunity kind of outside of that channel yourself.

Maybe turning to your guidance for the year, you gave 2026 guidance on the top line and then also EBITDA. Maybe walk us through kind of what expectations are built into those and, you know, given kind of the recent developments, how should we think about, you know, changes to those?

Yeah, I mean, we gave a range, and in the lower end of the range, which is 650 and 180 EBITDA, we did not have any of the three products which we are launching now into December, into US. And because it's only one month, we took a moderate value being shipped to U.S. on the high end. So that's kind of explaining the range. But with the confidence we have in, of course, the U.S. market, we strongly believe that we will be launching. So that was kind of the rationale when we gave out the guidance because the clarity was not fully there when we gave the guidance out a few months ago.

Yeah, that said, despite the FDA and some of the slowdowns that we take on, we should still see, Matt, that even at the lower end of the range, we're going to be 26, and once the wave of launches materialize, we will be in a significant period of growth over the foreseeable next few years, and we're really looking forward to that.

Great, great. You highlighted several times the biggest probably pipeline in the industry, but I think 30 molecules in the pipeline. Maybe kind of in the last few minutes, walk us through what is your strategy for selecting new molecules at this point? I mean, do you guys think of the revenue ranges?

No, it's a good question. I mean, we have always said we want to open up access for patients, and we are doing that in AlvoTec. I've been doing that in my career for 26 years. So if you're going to open up an access, we need to come with a molecule which is still not widely open for biosimilars. And that's why you heard us talking about first with high-dose biosimilar to Humira, first with Antivio, first with SubQ, with Antivio, first with Symfony, first with high-dose ILEA. Because if you're not first or in the absolute first wave, you are kind of not opening up the access if there are already five, six, seven players. So our portfolio strategy is evolved and developed around that. And as you can imagine, you start a journey with a product and then we usually take five to seven years to develop a product and we closely monitor what the brand is doing and then very often we adjust to what the brand is doing to be able to open access to the main strength or form of dosing they're adjusting to, if you will.

I think also on Robert's point, he said earlier, it revealed some of the secrets out there. We have an exceptional R&D team, and that's why we have been able to get so many of these unique assets, be the first to market. So six of the next eight to nine launches that we are looking at over the next few years, near to medium term, they're all going to be, we are going to be either the first to market or in the first wave of bisimilars. And that is why earlier called out an explosive period of growth for us over the next few years. And so we have, like, apart from these, we have Ilaris, we have Simzia, we have TALS. These are all assets which will have a strong revenue and debita contribution for us as we get to those periods.

Great, great. Well, with that, Robert and Balaji, thank you both for joining us.

Yeah, thanks for the invitation. We look forward to watching the updates over the coming month. Thank you so much.

Thank you so much, Matt, and Goldman for hosting us. And the great questions.

Yeah, thank you.