Teva Pharmaceutical Industries Limited

Thank you, Alex. Good morning and good afternoon, everyone. I'd like to remind you briefly that we're going to be making forward-looking statements on this call. Any statements we make are as of today only, and we undertake no obligation to update these statements afterwards. And if you have any questions about forward-looking statements or other risk disclosures, please see our SEC filings under Forms 10-K and 10-Q. And with that, let me turn it over to Richard.

Thank you, Chris. And good morning, good afternoon, everybody. Thank you for dialing in for the call. Really excited to talk to you today about the 2024 performance of Teva and the lookout for 2025. So as usual, I'm going to go back to the strategy, the pivot to growth strategy, what we set out in 2023 and what we accomplished of this strategy in 2024. As you remember, it's based on four pillars, deliver on our growth engines, step up innovation, create a sustainable generics powerhouse and focus the business. And I'm really pleased to say that we've made really good progress across 2024 on all of these pillars. As you'll see, Stato had another great year of 34%. He said he had a very strong year, beating his target of 100 million at 117. And Adobe grew at 18% and reached the half a billion dollar number. And StepUp Innovation, great progress there. By Eric and his team, obviously, we saw the results of DIVIKITUG at the end of last year, where we think we have best in class and best by design. And Olanzapine, we had the full safety data set, so we now know we don't have any PDSS in this patient population in this trial. And DARI, we've really moved fast into the clinic with our ICS SABA, and 91% of sites are recruited. On the generics business, all regions are growing for the second year straight, which is good, and our product launches have shown good performance to drive that growth. And then on Focus the Business, it was good to see external endorsement of the improvement of Teva with all the credit ratings improving their outlook for the company. And it's good to see that our TAPI business is back to growth, four quarters of growth and full year growth. So really good start and really good progress on the pivot to growth strategy. And how does this translate into growth? Well, as you see, eight quarters of growth we've had now after another years of decline. So there's a consistency here, which really pleases me, and congratulations to the team. Just like to highlight here, just for transparency, we have highlighted that one-off payment we got from Sanofi in Q4 2023. But this performance puts us on track to hit our 5% CAGR that we committed to in 2027. Now, to give you a bit of detail on this and the numbers, what drove the 9% in revenue, I'll go into that in a bit of detail, but let's start at the high-level P&L. $16.5 billion of revenue, up 9% to the high end of our outlook. Our adjusted EBITDA was $4.8 billion, also up 9%. And our non-GAAP EPS, $2.49, up 10%. Free cash flow, up 10%, also at $2.1 billion. And it's good to see that our net debt to EBITDA is now close to touching three. And I remind you all that We did give a guidance up twice throughout the year, so I think this performance is a strong performance and one we're very proud of. But let me now go into a bit of detail as to what's behind this. So all three of our businesses grew, our innovative business, our generics business, and our API business. As you see, led by Esteto up 36%, close to 1.7 billion, really strong performance again there. Adobe up 18%, as I said, just over half a billion. And you said 117. The generics business close to 9.5 billion up 11% and API at 3%. So across all of our businesses, we've driven this 9% growth. Now let's go into the innovative business first. So on a stater, I want to be clear. We are on target to hit our 2.5 billion in 2027. And you'll see why. Why are we confident about that? It's because the US revenues are 1.642 billion. It's a 34% growth. And we got strong TRX growth of 34% also. I'd like to point out it's a nice contribution from the rest of the world now starting to kick in with 46 million. And because of this confidence, we have our outlook of 1.9 to just over 2 billion for 2025, I think shows the strong belief we have in this product. I'd like to remind everybody there's still a huge unmet medical need. Of the 800,000 patients who suffer from tardive dyskinesia, only 6% are on treatment. So we see a long runway for this product. Now moving on to USETI. USETI, really pleased with what the team has done here. I think it goes to show what a really good differentiated product we have and what a world-class team we have out in the field. We did $117 million for the full year. So we beat our guidance of $100 million. And we're planning to do $160 million in 2025. So another growth contributor. going into this year. As we move on to a Jovi, I'm very proud of a Jovi. It's an interesting product. And when I came here, I think people weren't sure what this could do going forward. But I think the company and the team have shown what they can do, even in a very competitive market across all of our regions. The 18% growth, I think, shows the ability for our teams, whether it's in Europe, USA, or international markets, to take market share. And we've grown market share across all of our regions here. So congratulations to the team. And because of that, we're giving guidance of $600 million for 2025. So really good, strong contribution from our innovative business and a good, strong growth going forward into 2025. Now moving on to the second pillar, which is step-up innovation, which Eric will go into a lot more detail, but I can't help talk about it because I'm so excited about it. Um, so if you look at our late stage, uh, products here, Alanzapine, uh, ICS Sabah Dairy and, uh, Dubikidtuk, these are all products which are coming to markets, which have significant unmet medical need. Uh, and we come into the market, you know, in the near term, Alanzapine will be in 26, uh, ICS Sabah Dairy will be in 27, around about that. And Dubikidtuk will be towards a year or two later. So really excited about this. And we're entering phase three with Dubik-Keturk this year. And we'll be talking about some indications as well. Now, our early stage pipeline is also exciting. I'd remind people that the anti-IL-15 and the anti-PD-1-IL-2 were developed and created by the same team who created what we believe is best-in-class TL-1A Dubik-Keturk. So very excited about this pipeline. And Eric will go into a bit more detail. Now, moving on to the third pillar, which is our creative sustainable generics powerhouse. starting with our biosimilars. Our strategy was to build a broad portfolio, and we're up to 18 assets now, and you saw us do a couple of partnerships, a few partnerships last year to build out this portfolio even further. But I think what is exciting to see is between now, this year, 25 and 27, we will launch seven assets into the United States, and we'll launch four biosimilar assets into Europe. So this is really starting to build momentum and acceleration for our biosimilar business. And that will also help us drive growth on the top and bottom line towards our 2027 targets. Now going into the core generics business. Another strong year. And as I said, across all regions. And this was where we just started to tighten our capability and our focus operationally. We've improved our ability to launch our new products across all regions on time more often. We've improved our supply chain, making sure we can supply the market on time more often. And we're also doing some work. We did some work in 24, and this will continue to make sure we improve that efficiency within our supply chain so we can reduce our COGS and become even more competitive over the long term. But this TRX business grew at 11%, so very strong. Now, let me give you a bit of detail on what the regions did. And I think all the regions stepped up to drive this 11%. Another year of strong growth by the U.S. team, so congratulations to them. And Europe, 6%. As you know, this is a very big business, and we've seen mid-single-digit growth from Europe now consistently, so another strong year for the team. And international markets at 15% consistently deliver double-digit growth. Now moving on to the final pillar, which is focus the business. And this is where TAPI comes in. I'm really pleased with the work the TAPI team have done. We've taken this business from decline to growth and the momentum is increasing. And we have confidence that we can continue this growth into mid to high single digits. The third party business and the pipeline is growing significantly in 2024. We continue to see that happen in 25. And we continue with the divestment process. Now, talking about the fourth pillar, we always talk about capital allocation. We're very much focused on this at Teva. And just to remind everybody, you know, as we generate more cash, more capital, we'll put that to pay down our debt. That's the number one priority. But then we'll invest in the growth engines. As you see, we get a good return on that investment with Esteto, Ajovi and Yosedi. And then with this exciting pipeline, Eric also will get the capital to make sure that we can maximize that, obviously, because some of this pipeline will have the opportunity to go into a number of indications. And then we'll supplement all of this with business development. So that's what we've done in 25 from a business point of view. Now I'll hand over to Eric, who's going to talk you through that pipeline that we're so excited about.

Thank you, Richard. I first wanted to start off by saying we were very excited by the announcement of our top line results for our Do The Key Took program last month. The data speaks for itself. Great dose response in both ulcerative colitis and Crohn's disease, and these treatment effects are the highest reported for this MOA. So great work by the team, and we're very excited to show these results. You know, this was a validation of what we've been saying about the fundamentals of this program. Duva-Ketone has high potency in vitro, has high selectivity for the DR3 receptor, has low anti-drug antibodies, It shows a rapid, profound, and prolonged suppression of the free TLNA levels in the serum. And we've consistently shown a favorable safety and tolerability profile to date. So very excited by the data. And we're very pleased that this will be presented as late breakers for both ulcerative colitis and Crohn's disease at the ECHO conference on February 22nd in Berlin. So great work by the team. Now, this next slide, I could also say, It speaks for itself, but I don't want to say that today. I want to really walk through this because this is a very important slide when it comes to our Dupa-Ketog program. You know, TLNA is produced by a variety of cells, mucosal cells and immune cells. And the stimulus for the release of free TLNA is both microbial and non-microbial signals. But TLNA acts as a key amplifying signal. It binds to a variety of different cells in the immune system. that secrete a variety of different cytokines and trigger different signaling pathways. It also binds to fibrotic cells and has an impact on fibrosis and the maturation of a fibrotic matrix. Now, what does this mean? Well, it means that you can envision many different indications that this program could go into, from Crohn's disease all the way down to idiopathic pulmonary fibrosis. And to really put this in context, You know, we've listed a number of marketed products, as you all know very well. We know the impact that all these programs and these products have on patients worldwide. But it's important to remember these programs and products only hit specific subsets of these signaling pathways. So it's really exciting to think about the prospect of what a compound like Duvacutug could do when hitting this amplification signal of a variety of different cellular pathways. So it really is a portfolio and a product, and the future, I believe, is very bright for the birth of this new class of MOA. Moving on to our dual-action rescue inhaler program, very exciting program, very big program for TEVA. You know, it's important to remember there's 11 million people in the U.S. today who are still using a single albuterol, like, you know, Saba, single agent for their asthma exacerbation, so it's a large population. But we already know that GINA guidelines actually recommend using a dual-action rescue inhaler. You should be getting a beta agonist plus a steroid when you have an asthma exacerbation. So, HEVA is very proud to be bringing forward an easy-to-use dual-action rescue inhaler dry powder inhaler device. And to give a little bit more color as to why the dry powder inhaler device is important, it's the difference between what's available now, a metered dose inhaler, which is and the old spray-type inhaler device compared to our dry powder. And the difference is our product doesn't require any priming. It doesn't require any shaking. No hand-breath coordination is needed. No spacers are needed. And it's not complicated by cleaning. It's simply open, inhale, and close. So it's an easy-to-use product both by pediatrics and adults. And just to remind you what our phase three program looks like, it's a three-arm study. It's a large study of over 2,000 patients that we use two different doses compared to albuterol alone. It's exciting that we're including patients all the way down to the age of four through adulthood. It's a primary endpoint looking at asthma exacerbations, and it's an event-driven study. So our focus this year is enrolling it. We've got over 91% of our sites up and running at this point, and this is going to be a very big focus for us in R&D this year. And last but not least, our Lanzapine LIA program is right on schedule. Our last patient last visit will be imminently at the end of this month. We're looking to present the full safety database in the second quarter of this year at a conference, and we're looking for the NDA submission in the second half of this year. Very excited about this program. I think it's going to be an important product for patients with schizophrenia. And last, I just wanted to point out and pause for a minute and say how far we've come in the innovative programs at TEVA over the last two years. You know, I'm proud to say that all these programs now have dosed or are dosing in all these different indications at this point. As I mentioned, Alonsby and LAI, we're looking for the submission this year after the presentation of the last uh, data in the safety. Uh, the DARI program, as I mentioned, is our biggest phase three study to date at Teva. And we're really got a good head start on our, our site. Initiations do the key to it was a great, uh, end of the year presentation with the data. And we're excited to be working with Santa Fe to get the phase three started this year. And we're Solomon is dosing a high unmet medical need for multiple system atrophy. Anti aisle 15 is now in celiac and vitiligo. And last but not least, we're now dosing patients in our anti-PD1 IL-2 program in oncology. So it's been a great two years. I'm looking for more this year. And with that, I'm going to pass it off to Eli.