Hello, and welcome to the Teva Announces Collaboration with Sanofi for Anti-TL1A Therapy conference call. My name is Alex, I'll be coordinating the call today. If you'd like to ask a question at the end of the presentation, you can press star followed by one on your telephone keypad. If you'd like to remove your question, you may press star followed by two. Now I'll hand it over to your host, Ran Meir, Head of Investor Relations. Please go ahead. Thank you, Alex. Welcome, everyone, to Teva Investor Call, where we'll discuss our recent collaboration with Sanofi, focusing on Teva's anti-TL1A asset, TEV-574. Please take a moment to review our forward-looking statements on slide number two. You can find more details on this statement in our PR and Form 8-K released this morning, as well as in our SEC forms, 10-K and 10-Q. Today's agenda features Richard Francis, Teva's CEO, who will present an overview and the strategic significance of our collaboration. He will be followed by Dr. Eric Hughes, Teva's Head of R&D and Chief Medical Officer, who will be diving into the clinical program. Afterwards, Eli Kalif, our CFO, will elaborate on the transaction details and provide a financial summary. We will conclude with a Q&A session. With that, I will now turn the call over to Richard. Richard, if you would, please. Thank you, Ran, and good morning, good afternoon, everybody. Thank you for joining the call. So excited today about the collaboration, but before I dive into some details of that, I just would like to remind everybody that this decision has been made because it's in line with our Pivot to Growth strategy. As you know, we announced back in May, the Pivot to Growth strategy, which was based on four key pillars. One was deliver on our growth engines, which is about taking AUSTEDO to $2.5 billion by 2027, launching UZEDY, and continuing to grow AJOVY. The second pillar was step up innovation, which was to make sure we accelerate our pipeline and bring our innovative pipeline forward to the market. The third pillar was to sustain a generics powerhouse, and the final one was to focus our business specifically about creating a standalone business for the TAPI, API. Now, within that strategic announcement, we talked about returning Teva to growth in its first phase, then accelerating growth, and then continuing that growth. This deal is very much, and this partnership is very much about ensuring that that happens. So if you move to slide six, then we believe we're in the position of returning to growth now, and that is primarily driven by innovative products on the market, AUSTEDO and UZEDY. But with regards to the announcement today on TL1A, we believe this allows us to not only accelerate that growth in the midterm, but for the long term, to make sure we can sustain that growth going forward. And so we're excited by this collaboration because it allows us to optimize the TL1A asset, which we believe is best-in-class, and it allows us to use the considerable capability that we believe Sanofi has in immunology to help us do that. Now, I've said that, we believe it's best-in-class. We do when it comes down to potency, selectivity, and immunogenicity. We believe that, but obviously, you know, that's something which we need to prove with our phase II and phase III clinical studies. If you move on to slide seven, let's talk about this, what we call a transformative collaboration. I think we're very pleased that we've partnered with Sanofi. You know, when we looked at a partner with regard to our TL1A asset, it was all about finding somebody who could really optimize this asset. I think with Sanofi's deep heritage in immunology, both in R&D and in commercialization, I think we have found the perfect partner. And because of that, we think we can take this potential best-in-class to the market and have a very successful product. Now, as you can see on slide seven, the deal is up to $1.5 billion. And importantly for us, to ensure that we continue on this Pivot to Growth in the medium to long term, it's a 50/50 profit share. So for us, it was important that we had this joint commercialization. So we have a partnership in research and development, and we have a 50/50 partnership in commercialization. As you can see from the detail here, Teva will lead commercial efforts in Europe and Israel, being the major market, and Sanofi will lead commercialization in North America and Japan to focus on the major ones. So I think this gives us an opportunity as Teva to really continue to show our commercial capabilities as we've started to show with our innovative portfolio. Once again, driving the organization back to growth. If we now move to slide eight, I think what TL1A does is draw a spotlight again on our pipeline and highlights that this is an incredibly exciting asset within our pipeline that we're happy to talk about today. But this slide just really re-emphasizes that, you know, we do have two assets in phase III, innovative olanzapine long-acting for schizophrenia and ICS/SABA for asthma. And we believe these will add to our growth in the medium to long term. But as I've said before, with anti-TL1A, we really think this can drive long-term growth. And if you go on to the next slide, slide nine, this is, I think this really anchors my belief. You know, the market, it's a large market, the IBD market, you know, around $28 billion. It's largely underserved. I think it's well documented that there's significant unmet medical need, and so there's great potential here. And that really goes without talking about some of the other potential autoimmune areas we could go into, fibrotic indications, for example, that have often been discussed around this particular target. So the market size is significant. We think we believe we have a best-in-class asset here because of its competitive profile. We also believe that we have some good characteristics already that are documented. You know, our asthma study gives us great belief in the safety of this molecule moving forward. So as we move this into clinical development, we've indicated in the past, we're in phase II. We expect our interim results in the second half of next year. And then subject to FDA approval, the aim is to move into phase III in 2025. If we go on to slide 10, it goes back to the reason why we believe this collaboration is a great collaboration. It allows us to really optimize this asset, optimize it when it comes to driving innovation forward, using a partner who has great depth in immunology, both in innovation and R&D, as well as the commercialization of it. We do think this is a significant asset, often being described as a pipeline in a product. That has to be determined over time, but already with the two indications that we're going for in UC and CD, we see significant opportunity. So with this partnership, I think this really underpins our ability to deliver on our pivot to growth strategy, and it also highlights the quality of our pipeline, that somebody with the depth of knowledge that Sanofi has, has evaluated our TL1A asset and seen that to be an asset that they would like to bring into their organization. And obviously, because of that, and what I've just described, I do think we have an opportunity to really optimize this asset long term from a value creation point of view. But now I want to go and hand over to my colleague, Eric Hughes, who's going to go into a bit more detail as to why we've always believed in TL1A, the asset we have, but also now why our partner, Sanofi, also feels the same way. So over to you, Eric. Thank you, Richard. Can I have the next slide, number 12? So let me just quickly review why this is such an exciting mechanism of action. TL1A is a pleiotropic cytokine. It has an effect on many different pathways in inflammation. It acts as an amplification of these pathways, and blocking it has a potential impact on many different indications. In addition to this effect on inflammation, it also has the potential added benefit of affecting fibroblasts directly. This is very important since fibrosis is usually the end result in many indications from the inflammation. Important to also remember is that the body has a natural mechanism of turning down this inflammatory signal, which is the decoy receptor, or DCR3. So you want to block the DR3 pathway, but maintain the DCR3 pathway. So an important potential mechanism of action, with potential broad implications for the future. Can I have the next slide number 13? So why is TEV-574 unique? Well, I mentioned that the DR3 receptor is the important inflammatory signal to block, while the DCR3 decoy receptor is a natural way in which we can turn down the signal. So you'd want to block the inflammatory signal while maintaining the decoy receptor. So, TEV-574 was carefully designed by our scientists to be potent. It has subnanomolar affinity for TL1A. It has a unique binding site to TL1A, and this unique binding site is what blocks the DR3 receptor while maintaining the decoy receptor, DCR3. We think this is a unique biology for our antibody, and it's one that we've worked on for many years now. Can I have the next slide number 14? Now, let me dive into a little bit more of why we believe TEV-574 has the potential to be the best in class. So starting from the left and going to the right, on the left, you can see in this in vitro assay, in a competitive assay, we show here that TEV-574 is in fact more selective for the DR3 receptor over the decoy receptor. In fact, it's about 117-fold more selective for the important receptor of inflammation, DR3. Now, we've created comparator antibodies from publicly available information from other clinical candidates in development. And you can see in that first comparator, TL1A number one, you can see the selectivity really is not there. There's about a threefold difference between the decoy receptor and the DR3 receptor. So we're about 40-fold more selective than this comparator. Now, when you and you can also see in these two graphs that the potency of the TEV-574 is approximately 64, 60 times more potent than this TL1A comparator. Now, in the right graph, you can see the second comparator agent that were more potent directly in comparison in this inhibition assay. You can see that the TEV-574 is about 84 times more potent than this second comparator. So in summary, this in vitro data really makes us have the belief that we are the potential best in class based on greater potency and greater selectivity. Can I have the next slide? Number 15. So, you know, it's great that we've now also looked at non-human primate models using our antibody to show that, in fact, we have rapid and a prolonged suppression of free TL1A. So here I'm showing an experiment in four non-human primates, given a single dose of TEV-574. And importantly, I'm showing you the free TL1A in the serum. That is the biologically active cytokine. And you can see a very rapid, robust suppression of levels below the baseline, and that's maintained for about 14 days. So our design, our potency is clearly shown in this non-human primate on the free TL1A levels. Can I have the next slide, number 16? So in summary, you know, we believe TEV-574 has the best-in-class profile. We have greater potency and selectivity compared to comparative reagents. We maintain the decoy receptor, and we've already shown in animal models that we can decrease fibrosis. We're happy to see a favorable safety profile in our asthma study, and we've seen less than 10% anti-drug antibodies, which is critically important for long-term efficacy in the future. We're focused on maintaining and having a subcutaneous auto-injector single shot in our phase III studies. Go to the next slide. So just in summary, I want to make sure that everyone knows that we have more than just TL1A at Teva. You know, we're focused, we're hyper-focused on making sure that we have our phase II interim analysis of the second half of 2024 in our TL1A program. But we're happy to see our phase III program in olanzapine LAI enrolling very quickly, and we're anticipating results next year in 2025. I'm happy to say that we've dosed our first celiac patient with anti-IL-15, and our phase I program is moving very quickly with TEV-408. Our anti-PD-1 IL-2 program in oncology is moving very quickly for our first in-human studies next year. And importantly, we've also now enrolled our first patient in our phase III program of ICS/SABA. So many things are going on in the innovative side of Teva, and we're excited to have this collaboration with Sanofi on our TL1A program. And with that, I'm going to pass it off to Eli Kalif. Thank you, Eric. We move to slide 19. Hello, everyone. I will briefly discuss key collaboration terms and financial impact. We ran an extensive process involving a number of parties and ultimately decided on a 50/50 worldwide partnership with Sanofi as the optimal path for Teva. We didn't want to sell the assets, but rather to keep it in-house, optimize it, and get the most of it. This collaboration allows Teva to achieve our strategic objectives and participate in what we expect will be a very significant economics for the long term. Opportunity to build on the joint capabilities, expertise, and resources of Teva and Sanofi to maximize the value of the assets. This structure is very similar to other collaborations, which resulted in a highly successful multi-billion-dollar asset. Now, looking on the key details of the deal structure. First, it gives us a significant cash upfront, $500 million and up to $1 billion additional proceeds based on milestones, the majority of which are expected in the near term when we are moving the assets into a phase III. Our cash flow profile also sees improvement through a shared development cost with Sanofi, which is meaningful given the expected size and duration of phase III studies that will be needed. We'll be able to put all the required resources behind the assets to optimize development and launch while unlocking material savings for Teva through a 50/50 cost and profit share. This collaboration will maximize the economics to Teva and have a material impact on our cash flow and bottom line, helping Teva achieve its strategic goals and financial objectives. We're expecting the transaction to become effective after customary closing conditions before year-end. Turning to slide 20. While we introduced our Pivot to Growth strategy, we're very clear about our capital allocation strategy. We established a very comprehensive capital allocation strategy in order to make sure that we're able to fuel our growth and innovation and balance with our financial commitments. We think about our capital allocation in the following order. First, keep de-leveraging, keep reducing the debt, and making sure that we have a strong balance sheet. Keep investing in our existing growth drivers, AUSTEDO, AJOVY, and UZEDY, and also support new launches in order to keep our competitive advantage. Prioritization of investment in R&D to support the pipeline, fostering innovation, and advancing our product offerings. Lastly, we plan to execute our future growth strategy also through disciplined, strategic business development opportunities, including partnerships in license deals and focused M&A that aligns with our core business and growth strategy. With that, I would like to turn it back to Richard for a summary before we open up the call for Q&A. Thank you, Eli. Thank you, Eric. So yes, on slide 21, I think it summarizes a lot of what my colleagues have said. I think it's the deal and the structure of the deal with the partner we wanted. So the 50/50 joint collaboration with a probably the leader in immunology, I think is what's important to us. The economics are important to us as we drive our Pivot to Growth strategy. And so, as Eli pointed out, the cash payments and the significant milestones are important, but I think very important for our long-term growth is the 50/50 split on the economics and on the profit going forward. And I think it goes to add, as we considered partnering, is to find a partner that really we thought was synergistic, both culturally and somebody from a capability. And with Sanofi, because of their immunology heritage in R&D as well as in commercial, we believe we found the ideal partner. If you go to the final slide, final 22, then I would like to just remind everybody that this is merely a part of the plan of executing our Pivot to Growth strategy. It's an exciting part and one we're very pleased with, but there are still many aspects of the strategy that we're executing continuously. And this, I believe, will start to give people confidence that the Pivot to Growth strategy is one that can be executed because it is being executed, and we will be able to deliver across these four pillars as we go forward. But obviously, that is for us to show and to prove, but I think this is one of those steps on that journey, which hopefully starts to give people some confidence and belief that that can be done. So with that, I'd like to finish and open the call to some questions. Thank you. Thank you. As a reminder, if you'd like to ask a question, you can press star followed by one on your telephone keypad. If you'd like to remove your question, you may press star followed by two. Please ensure you're unmuted locally when asking your question. Our first question for today comes from Jason Gerberry from Bank of America. Jason, your line is now open. Please go ahead. Hello, guys. Thank you for taking my questions. So I guess, you know, firstly, how do you think about this deal accelerating development efforts for 574? Do you think that, you know, with the partnership that you can move more quickly into phase II studies for other indications, or will you wait for the IBD data before advancing, 574 clinically? And then my second question: so you've got three undisclosed doses in your phase II for IBD. Do you agree with competitor assertions that 574 is gonna require a large volume sub-Q loading dose, followed by two weekly sub-Q infusion as opposed to sub-Q injection? So just curious if you can comment on those aspects, of the profile. Thanks. Thanks, Jason. Thanks for joining the call, and thanks for your question. So Eric, I'll, I'll hand that one to you. Sure. Thank you, Richard. So, you know, we're excited to be working with Sanofi on this. The capability of Sanofi and their heritage in immunology is a, a perfect match for our R&D team at Teva. I think that with the combined capabilities, that will not only accelerate the development of the compound and the IBD indications, but we'll be able to collaborate and, you know, focus on other indications in the future. As you appreciate from what I discussed before, the potential is broad for the anti-TL1A program. So that is a, a, a good reason, and, and not to mention the cultural fit between the teams. They get along very well. With regards to the questions around the study design and the dose, so we're focused on creating an auto-injector with a single shot to maintain the convenience for the patients, and that's what we're gonna be including in phase three. So a very competitive auto-injector is planned. Got it. Thanks. Thank you. Our next question comes from Umer Raffat of Evercore ISI. Your line is now open. Please go ahead. Hi, guys. Thanks for taking my question. Maybe a couple here, if I may. First, I got to believe Sanofi would have gone through your prior asthma data as well as your sub-Q. Just wanted to confirm that. Also, I know you've discussed your potency versus other TL1As from the preclinical experiments, but I do wanna ask, knowing that you have three different doses in your ongoing UC Crohn's study, is at least one of your dose levels getting to at least 500 milligrams like your competitors? And is Sanofi fully comfortable with the doses you have chosen? And then finally, your partners had that in indications beyond UC Crohn's, for example, asthma, et cetera. Thank you. Sorry about that. So just, I'm gonna hand that to Eric to answer, but I would just say with regards to the data, as you'd imagine, the due diligence was significant and thorough... by Sanofi, and we showed them everything. So I'll just start, before I hand over to Eric, by saying that, they got to see everything, and with their knowledge in immunology, the fact that they wanted to partner with us, I think it gives us a lot of credibility around our science and our antibody engineering capability. But with that, I'll hand it specifically to Eric. Yeah, yeah, Umer, so I'll just reiterate that, you know, the review with Sanofi has been thorough. We've reviewed all the asthma data. We've re-reviewed all data with Sanofi, and it's been a very collaborative back and forth and review with the scientists of the entire program. More specifically, when it comes to the asthma data, we will be submitting that data this year for presentation. We're targeting a presentation in February of next year, after we re-submitted the data this year. Thank you. Thank you. Our next question comes from Nathan Rich of Goldman Sachs. Nathan, your line is now open. Please go ahead. Great. Thanks a lot for the questions. I just wanted to get kind of confirmation on timeline. I think, Richard, you had talked about maybe a potential to accelerate. Are you still thinking the decision on the phase III trials will be made, you know, in the back half of next year after the interim results? And are you still targeting, you know, to bring the drug to market around 2028? And then can you talk about how decisions around future indications might be made under this partnership as you think about, you know, potential to expand? Yeah. So thank you, Nathan. Thank you for the question. I'll probably answer this with Eric as well. So on the phase III data, obviously, we'll have the interim analysis done in the second half of last year, which Eric has already talked about, you know. And based on that, and based on, you know, FDA input and approval, would aim to move into phase III in 2025. With regard to the operation of this, this is, you know, in a typical fashion, this will be joint steering committees, joint development committees, but maybe I'll use that opportunity then to Eric to discuss that and how that's gonna be done operationally. Yeah. So, it's a good point, a good question. It's a lot of value for the program going forward is multiple indications in the future. I don't want to speculate on which ones we'll go into first. That's something that we'll have to do once the deal's completed and discussed with Sanofi, but that's certainly part of the plan. You can see in the in vitro data that there's an effect on multiple different important cytokine pathways. The list is long. There could be an indication for this MOA. But I don't want to speculate on the first one. I think that we can provide a list of 10 at some point, but right now, we're focused heavily on making sure that phase III study gets started in IBD as quickly as possible and maintain a competitive timeline. Thank you. Thank you. Our next question comes from Ash Verma of UBS. Ash, your line is now open. Please go ahead. Hey, thanks, for taking our question. Congrats on the deal here. So, from the geographics that here, are you confident that Europe or, broadly ex-US, is the right market for you to get the right for? A lot of the focus has been for US. I'm asking this, both from a commercial infrastructure perspective and from market attractiveness perspective. And then secondly, just, outside T L1A, anything that you can comment on other partnership or asset sale opportunities that you might pursue, either for branded or mature business? I know, and that comes up frequently in, investor conversations. Thanks. So Ash, thanks for your question. So I think, when we think about... So from Europe, we, you know, people forget that Teva has a great capability and heritage in innovative products, and we still have that in the company now. It's often forgotten. So we think we have very much the ability to launch an innovative product like TL1A in Europe. When we talk about the attractiveness, this goes back to sort of also the capability of the partners. So Sanofi, with their immunology capability, then I think, and what they've shown and proven they can do across the world, but particularly, we've seen that in the US, I think that's a good partner. So I think we need to play to the strengths of each of us and leverage those, and that's clearly what we're doing with this and with the geographical split. When you talk about other assets and sales, and specifically ANDA, so there's no plans to sell ANDA, just to answer that one directly. But with regard to other things, what I would say is, I think already people are starting to realize that the pipeline that Teva has may not be broad and deep, but it's of high quality. And so we do have interest you know all the time about what our pipeline is, but we have no desire to sell any of our innovative assets. You know, we saw a partnership here as maximizing the value of the asset rather than monetizing it. It was about making sure we had a partner who could allow us to maximize that. So I think that's how we think about that. And then anything else that with regard to your thinking about with regard to our divestments, we don't have those in plan for the innovative portfolio. We're very clear on what we need to do to drive our pivot to growth strategy across our four pillars, and we're in the process of executing that. I would point out that the geographical split is about how we execute it, but it's important to keep in mind that the profit share is 50/50 global. So Sanofi executing in the US, that is a 50/50 profit share. Us executing in Europe is a 50/50 profit share. So once again, leveraging the capabilities of our partner, but benefiting from those capabilities geographically. I think it's a win-win for both parties. Thanks for your question, Ash. Thank you. As a reminder, if you'd like to ask a question, you can press star followed by one on your telephone keypad. Our next question comes from Chris Schott of J.P. Morgan. Your line is now open. Please go ahead. Great. Thanks so much. I just had two questions. First, does this deal and just some clarity on this and having a partner and, you know, moving this forward, change at all your capital allocation kind of priorities and how you think about, I guess, the debt paydown versus further in licensing, or just how you think about cash flow going forward? Then kind of my second question was just about the timing of the transaction. It seems like you found a great partner here, but how did you balance kind of thinking about doing a deal now prior to the phase II data, versus waiting for that interim phase II data, where you might be able to get, potentially even enhanced economics, you know, just based on how some of these assets have traded in the market? Just a little bit about how, you know, kind of thinking about now versus waiting. Thanks so much. Yeah, thanks, Chris. Thanks for the question. I mean, Eli, Eli highlighted our capital allocation priorities, you know, pay down debt, invest in our growth assets, and do BD. And I think, you know, I'll let Eli speak about that in a bit more detail, but that's pretty much our, our roadmap that we've outlined in our strategy. But before I let him do that, You know, the enhanced economics that you talked about, I think for us, this was—this was about making sure that we get some real focus behind this asset as soon as possible. You know, we believe if this asset can take a significant part of that $28 billion market, then I think it's important to get that partner on board as fast as possible. I think that's where you create the most value, particularly when you have a 50/50 economics in the profit share when you bring it to the market. So for us, it's about, you know, once we found the right partner in bringing them on board, because of all the things we've said about what the partner brings to it, it makes sense to have that come to the table sooner rather than later. But I'll hand over to Eli to talk a bit more about the transaction timelines and the capital allocation in a bit more detail. Thanks, Chris. So, as for the, you know, we mentioned already in the prepared remarks as well, in our calls and when we actually discuss about the growth strategy, we remain at our capital allocation strategy, which mean for the short term, if we talk about the upfront and the immediate upfront, we're, we're looking into it, that's going to serve us, you know, both to improve our balance sheet in terms of net debt ratio. And also, you know, think about 2024, 2025 with the ability to get the effective date, and I'll talk in a minute on the timeline as faster as we can. It means that it's kind of immediate impact on the 50/50 share on the cost of the development, which mean that it will free resources, immediately, allowing us to prioritize, other programs for our late and early stage in terms of the R&D. From signing to closing, you know, it really depends on, you know, HSR, submissions related to FTC and DOJ and, and what have you. So that will take, I believe, a certain period of time. And we believe that subject to the deal closing during Q4, the upfront payment and other deal terms will impact our financial for Q4 2023. And we will be more, I would say, smart when we go into the earnings of Q3 and explain about some updates there. But then it really depends on the timing of the closing as for the short term. But high level, we still see ourselves going through the same order that I mentioned in my prepared remarks as related to the capital allocation. Thank you. Thanks, Chris. Thank you. Our final question for today comes from Harry Gillis of Berenberg. Harry, your line is now open. Please go ahead. Hi, and thank you. Just a couple of quick questions from me, if that's all right. So could you just confirm the dosing frequency in the phase 2B trial, and that you expect the same frequency, in phase II, when you have your auto injector? And then secondly, just when you expect patent expiry in the US. and EU. Thank you. Okay, Eric, do you want to take those? Yeah, sure. So we're planning on multiple schedules in the program, and we're focused on making, as I mentioned before, a single-shot auto injector for the convenience of the patient. So that's the plan right now. So I think, if that was the last question, then I would like to thank everybody for joining the call. I appreciate the invitation came in at last minute, so thank you for taking the time out of your busy schedules to jump on the call. Thank you for that, and appreciate your interest, and look forward to talking to you when Q3 results come out in a few weeks. Thank you for joining today's call. You may now disconnect your lines.