Good morning, everyone. My name is Balaji Prasad. I'm the Senior Analyst for the Barclays, Specialty Pharmaceuticals coverage. For the next session of the day at the Barclays Global Healthcare Conference, I have the pleasure of hosting Teva and Eli Kalif, the Chief Financial Officer from Teva. Eli, thank you so much for joining us today. It's a pleasure to have you here.
Thank you for having me. Really excited to be here.
Yeah. It's a very interesting phase for Teva now with the CEO change and everything else. Considering that you had your earnings call recently, why don't you start with a couple of recaps from your earnings call and then we can get into Q&A.
Yes. Yes, we're really excited to have Richard with us. I think over the last several years, the company really focused on how to be able to stabilize the optimization to make sure that our capital allocation really focused on serving the debt and keeping our restructuring capabilities, taking a lot of cost out of the system. With the coming new CEO, Richard Francis, and his well experienced record, we see ourself now positioned into growth. What does it mean? It means that we initiated already in the last two months on ongoing strategic review.
That strategic review ongoing with several work stream sprints that will go across the companies, with dedicated teams, that going through any assets, any operations, any portfolio that we can think about on thinking about growth. What type of activities we want to focus on, what type of activities we want to stop focus on, and everything is how we envision our working capital as well, our capital allocation in the future in order to drive growth. I think that, you know, coming from the earnings, one of the most major element was our offering that we did in the last weeks. We actually offered to $1 billion on Sustainability-Linked Bonds. We upset that deal to $2.5 billion with the tendering of the same $2.5 billion.
We announced yesterday on the tendering finalization. Really happy with the fact that we have kind of a clear runway for the next three years with an average $1.6 billion-$1.7 billion debt stake for 2023, 2024, 2025, that enable us to secure liquidity, which mean that's going to be paid from our organic free cash flow and really helping us focus in on a strategy on growth.
Thanks for that recap, Eli. As I said, I think, the task for Teva is clearly cut out. You have the growth mandate that Richard will be driving, and then you have the capital allocation thoughts and priorities, which you've been navigating very well over the last couple of months, especially. Maybe starting with Richard and how should we think about his top priorities for the near term and then the major focus items or priorities for the longer term, what does a growth mandate for Richard translate into for Teva?
Yes. I think if we're looking, first of all, on our existing portfolio. If you think about generics, yes, we have in U.S. generics as all the rest of the players, we see some kind of a stabilization in terms of the pricing, but we're also looking on the ex-U.S. generics. If you think about it, more than 60% from our generics is ex-U.S. It's around $5 billion, just ex-U.S. They're super stable, really predictable, growing nicely in terms of the margin. This one we keep on focus. On the U.S. generics, we'll be focusing more as we speak on complex generics, everything related to inhalers, patches, all type of injectables. We truly believe that the value is there, although it's taking a lot of time, unfortunately, to get the right approval on time.
We demonstrated in the past with few assets that it's worth it. We keep focusing on that. I think that if you think about biosimilars, currently the focus is really to grow those capabilities. We have on our portfolio around 16 assets on biosimilars, three already in the market, five with a partnership with Alvotech, and eight kind of homegrown. An integrated R&D organization that we have the ability to do an innovative R&D on both biosimilars and generics. Having the knowledge as well on innovative, we think that we're really positioned well on how we're able to keep putting a nice product in the market. I think it is related to Richard, and I will talk about also on the innovative. I think it's related to Richard.
It is having kind of a view on the existing capabilities, understanding where is the tail, where is really those elements that can able and move the needle, looking onwards on our capital allocation strategy. For us, in order to create a shareholder value, it's about either accretive on our earnings, which in some way will enable us to grow our price to earnings multiples and either to create kind of a sustainable growth. Also will create kind of a more stabilized business for us. As far as related to innovative, as you know, we truly believe that AUSTEDO is a great asset.
Mm-hmm.
As we speak, we actually announced several weeks ago about AUSTEDO XR, it's the once daily. It came with the 624 mg. It's additional treatment in terms of our products prospect that we can actually offer now to patients. As you all know, AUSTEDO, we have, like, around 800,000 suffering in the U.S. Only 15% of them diagnosed and only 5% be on treatment. It's really how you're able to, you know, get the right treatment and dose it properly for the patients on the drug, keep focusing on compliance and adherence, and as well, really looking on the growth. We did with AUSTEDO in average, like year-over-year, around 20%. We're looking on a $1.2 billion.
Part of the strategic review that we're doing now is all type of abilities to grow organically specific assets. Not only that one. You know, if you're looking on our working capital, we're trying to understand what is actually less accretive, more accretive in terms of cash and how we're actually able even to look on specific assets in the future and to ask ourselves if they're actually incremental into our growth or they can actually we can monetize and think about differently on certain assets in the company. We, as we speak, we see ourselves coming before the second half of the year somewhere, I believe very close to our Q1 earnings.
To come and explain to the entire world our strategy, where we're focusing and really to put kind of very clear equity story to make sure that people understand exactly where we're yielding. Knowing that we'll keep focusing on optimizing, keep serving the debt on the level that we put ourselves at least for the next two years when we set that runway now with the latest refinancing. Make sure that both our bondholders, both our shareholders really understanding how we're able to drive growth.
Great. Thanks for that comprehensive overview, Eli. Let's start with maybe picking one, each one of these, the biosimilars business. When we hosted the lunch with you and Richard and Sven a couple of weeks ago, he was speaking about his belief in the opportunity and that it's going to be a meaningful one. It's also interesting for me when we think about 2020, where Teva literally had like, what we knew was two assets which were already commercialized. You didn't seem to have a pipeline, and then the Alvotech partnership happened. All of a sudden, you are like looking into, you have an inside view into Humira, Stelara, potentially Keytruda and all. Bisimilars, as we think about this, starting with this year and then the your own internal programs too.
What size and shape could this take over the longer run in a couple of years from now? How big can the biosimilar opportunity be for Teva?
Yeah. If you try to kind of look, you know, broadly about the biosimilars. In the last five years, there was around $25 billion worth of biological assets that went out of patent. In the next five years, that number is more than double. It's around a bit above $70 billion. If you have currently the existing platform on generics and the existing capabilities, you want to make sure that you have a really deep portfolio and you capture enough percentage from the out of patent. That was the strategy. As I mentioned, as you mentioned, with the Alvotech, we did kind of a catch up into the market.
Mm-hmm.
It's kind of five assets. We have Rituximab, Truxima with the Celltrion. We have initiated also earlier last year, Lucentis, and this one is mainly Europe and also in Canada. We have kind of an eight homegrown assets in different phases. Part of, you know, our investors day and our strategy review, we're going to expose part of them to explain our capabilities and our technologies in order to support those launches. One of the things that, you know, biosimilar is the new generic because more and more biological go out of patent.
You know, it's kind of, for us, due to the capital allocation restrictions that we had in the last several years, we're looking on this type of deal, Alvotech, where, you know, the partners have the ability to manufacture, do the developments, and we're actually creating kind of a win-win situation and leveraging our go-to-market capabilities, in that case, exclusivity in the U.S. We see that one keep growing, we're working on that one, I would say more focused.
Mm-hmm.
We truly believe that as much as we're able to build our capabilities, and it's not only in terms of how we're able to contract, launch and develop, it's also how you're able to manufacture and how you're able to source and how you're able to be less dependent and have more flexibility. We also need to remember that those partnerships most likely doing kind of a profit share, which is a bit lower gross margin. The homegrown, it's higher gross margin.
Sure.
You're actually trying to build kind of a flexible, I would say, platform in your biosimilars in order to be able to act on any movement from the revenue mix, so your profitability will align as well.
Understood. Maybe starting with biosimilar, I think, that's going to be probably a critical point in terms of how market views your biosimilar capability coming with next with Stelara potentially and also. Oh, I wish we had Alvotech here, and I wish the inspection had been over, but it's not. The inspection is still ongoing. Alvotech is being also inspected for pre-approval inspection for biosimilar Stelara. Which takes time to come to the conference. I know it's still, you're still a couple of months away from them, but I want to understand your level of confidence for an on-time launch in July, Humira, and your ability to supply. How should we think about it?
Yes. You know, talking about the next five years, more than $70 billion for sure, it's like the majority is around 10 S. One of the big one is Humira, as we all know. Amgen already launched, right? In January. Their product, for you to understand, it's low concentration, not interchangeable. Majority of the revenue of Humira, the originator, is like around 85% is really on high concentration. Our product profile is high concentration, citrate-free as well, and interchangeable. We truly believe that it's super important to get Alvotech to get the approval. As we speak, the inspection started on March 6th. It's ongoing with the ultimate goal that the FDA committed to provide their response by April 13th.
We know the next few. What's really important to understand here is that the way that we see it, and also with that there is another pre-play, I think, yeah it's end of June and another two early July , later on the state we have another three. Really understand is our profile currently is uniquely positioned, and as long as the innovator will still be on their formulary, which means that's creating a competitive advantage.
Mm-hmm.
For Humira that we're going to launch in the U.S. due to the interchangeability. You know, we're working constantly with the PBMs. We have the right strategy with them. They will also, part of them, able to understand, you know, the entire manufacturing process that has Alvotech. Really just, it's just about, you know, waiting to the approval and our ability to execute. We are really, you know, line up with everything that we need.
Understood. There are two comments there. One is getting the approval, inspection approval done. Another part is the formulary discussions which are going on. Can you throw some color on the second part and also help us understand? I mean, I think most investors still understand that the interchangeable icon special version is kind of what keeps you in the game despite not having the inspection approval yet. But help us understand the, how the discussion is evolving and, where you see on ground.
First of all, also for the interchangeability, there is no production date, right? This one is also in condition to the re-inspection, and it's very important to clear. You know, the way that we see it's, you know, we didn't really took in our guidance much. We really de-risked the launch for 2022. We look in that one more kind of four or five years beyond 2023, right?
Okay.
Because that's the way that we are positioning ourselves. Our discussions with the potential PBMs is super strategic discussion. It's not just, you know, for what we can do in the coming year.
Okay.
It's how we can position ourselves going forward. We truly believe that the way that the market will see it will create a kind of a many pre-inflection point. First of all, as I mentioned, the Amgen, which is different profile that we have. That with certain level of acceleration. If we will be able to get the approval on time, I think that will change the dynamics.
That will dictate, I think a different, I would say strategy to the rest to understand how they can position mostly related to what you mentioned, the formality, the formulary with the originator. We're not thinking about it, you know, kind of a 2023 game. We're thinking about a 2024 and beyond. I cannot, you know, provide more details about, you know, how this one is progressed, but we're, you know, really out there.
Fair enough. In the interest of time, just shifting towards the pipeline on the specialty side. I do want to get your thoughts around the UZEDY opportunity, and are we still on track for a potential action date in 1S 2023? Just help us understand the market share opportunity and what your goals are there.
Yeah. UZEDY is, it's risperidone. If you think about this whole entire market landscape, this is about 1.6 million patients. Currently only 13% treated with LAI, long-acting injectable. What we offer as part of UZEDY, it's a different profile. It's a more friendly patient profile, which means it's a sub-Q. It's having a small needle, a low volume. It's a ready-to-use pack with a pre-filled syringe, and that is something that we believe that's going to get a lot of attraction. The total LAI market currently is around $4 billion. We believe that that's going to have kind of a certain penetration there. As you mentioned, we refiled it back in November. We plan to get the approval by the first half of this year.
The way that we're looking on that one, it's also we started the phase III in olanzapine, and we plan also to have this one ready with LAI, and most likely somewhere, early next year, we're going to see some results. Those both of them creating a nice franchise because if you think about it's really aligned with what we do, Cinqaero. As we know, disorder movement with the TD is really kind of a side effect for our treatment on schizophrenia. With that, you're creating kind of a franchise, and we truly believe that our capabilities in terms of innovation and how we're able, you know, to bring innovative product into the market. You know, you think about, you know, launching Ajovy and AUSTEDO.
you know, in the last several years, where the company was struggling with erosion on capacity and debt restructuring, overhang and litigation. Still those two products were very successful in the market, where AJOVY was a bit, you know, late in the, in the page. With that one, we truly believe it will be super successful if it gets, you know, the approval in time. We're really pushing that one. Really excited about it, and we think that it's creating, as I mentioned, the right franchise and enable us to position another grade two asset into growth.
Got it. Great. Could you also just take us through the synergies that you expect between these three products, between subcutaneous olanzapine and VYEPTI and AUSTEDO? You also called out the approval of the AUSTEDO, you know, XR version.
Yeah. The synergies, it's mostly about, you know, go to market. It's mostly about the sales force. It's mostly about how you're able to make sure that you have properly dosed the treatment and make sure that you have the right compliance and adhering. We, we see ourself looking on how much we can still more invest in those two areas in terms of sales force, in terms of capabilities and initiatives around the sales and marketing.
As you mentioned, in terms of the once daily AUSTEDO, that was kind of another example on, you know, our capabilities and how we're able to penetrate and we're looking also further, you know, to different doses, how we can actually be more impact there. I think it's all about, you know, our ability to create those synergies and to make sure that our sales force is enough diverse, to able to get the patients on the drug and increase adherence. So.
Got it. I think I do want to get some questions on the generic side. The ex-U.S. Component is probably well understood, bit more hazy, but also well understood that it's still a growth segment. The U.S. component, and now that you have Christine Baeder, who is now the Chairman of AAM, taking on from Drug and he had been kind of leading the charge in pushing back against the PBMs. Christine seems to have the same viewpoint too. Do you kind of see this deadlock breaking on the generics market where the buying pressure, buy-side pressure is going to ease at some point? You called out stability. At any point in the next couple of years, could we see a more balanced structure here on the-
I truly believe it's right. For us, you know, in terms of financials, it's really depend on how much we're able to launch in any given year, right?
Sure.
If you think about the dynamics in the last, I would say, two years heading to this year, and we had less, I would say, launches in 2021. 2022 was really dominated with the Revlimid, and in 2023, we're going to have more share in Revlimid. Of course, we cannot expose this one. It's under this.
Mm-hmm.
What you will see us selling more and really excited about this one. We also announced something on that one as well to signal about another two strengths. I think it's really about, yes, there will be keep certain level of erosions, but our ability to launch on time, our ability to get, you know, as it's needed, right, inspection. I also mentioned few complex generics that actually changed the, really the needle in the coming, two to three years. This is as far on the financials. I think if you think about the economics about this one we are focusing again currently to capture around 80% more or less from the out of patent.
Mm-hmm.
As we speak now, we have more than 900 pending approvals. It's, you know, it's massive, right? The ability for us to make sure that we're providing the right solution, the right penetration to the patients, not necessarily, you know, have the ability to always, you know, fight on the right pricing. Although if you first to launch, you get some, the right advantage. I think what we offer as the generics is part of our mission to be, you know, we're committed to be the largest generics. I think this one will, you know, be a really game changers and keep being game changers to this site.
Got it. Maybe in the... We're just out of time-
Yeah.
I'll put in more questions. Something that we discussed last evening. As you look at all of these things and the opportunities are clearly evident, they are much larger than it was three years ago, what are the biggest challenges for Teva now? You said the opioids backend, which is fantastic. Growth opportunity is great. What are the challenges?
I think the challenge is to make sure that we coming very clear with the strategic review.
Mm-hmm.
We come very clear with what we plan to do and make sure that the entire organization is aligned and understanding that we're actually moving into kind of a growth mode, and have the ability to become super clear, both to our shareholders, our bondholders, any other stakeholders, to explain how we're looking on our capital allocation in terms of growth.
Knowing that we still carry heavy debt, which mean in the next two to three years, we keep allocating from our free cash flow, and we actually already signaled it in this latest refinancing that we very nicely equipped with the $1.7 billion in average to pay the debt. Which mean one of the most challenging will be to make sure people understand how we split our capital allocation.
People think it in a different way, you know, to support growth. As part of those strategic reviews, understanding what we're going to keep doing, what we're going to starting to do, and what we're going to stop doing. That will be the challenge in the next three years.
There's a fair bit of change management, organizational management, things that you have to handle.
Yeah.
Okay. We'll all look forward to the strategic review. Eli, thank you for your time and sharing your thoughts, and I wish you a very productive conference.
Thank you very much.
Thank you.
Thanks for everyone that, for your interest in Teva. Thank you.