Morning, everyone. My name is Farzin Haque, and I'm a biotech analyst here at Jefferies. It's my pleasure to introduce Raul Rodriguez. He's the CEO of Rigel Pharmaceuticals. This is standard presentations, and we'll take some Q&A at the end. So, welcome, Raul. Thank you. It's nice to be with you, and thank you to the Jefferies team for having invited us. It's always nice to present during the middle of the year on our company. So let me tell you about Rigel Pharmaceuticals. First, though, please read these important forward-looking statements, also available on our website for your review. The Rigel story is a story of building a hematology and oncology business, and there's two pieces to it. One, our commercial business, and I'll tell you about two products, Tavalisse, or fostamatinib, which is indicated for adult chronic ITP, and Rezlidhia, olutasidenib, which is indicated for mutant IDH1 relapse and refractory AML. The second part of the business is what's coming, products that are joining the portfolio, and I'll tell you about Gavreto, what we're looking to do in terms of adding additional new products to the portfolio, and importantly, development programs that are coming. In Rezlidhia, looking at mutant IDH1, products in indications in AML, in MDS, and in, importantly, glioma. And finally, R289, our IRAK1/4 inhibitor, which is in phase Ib for low-risk MDS, where we should have data at the end of this year. So important developments on that side as well. But I'll tell you about all of this in a succinct 20-some minutes, so if I rush, I apologize. First, let's start with Tavalisse. Tavalisse is indicated for the treatment of adults with chronic immune thrombocytopenia who had insufficient response to a previous treatment. Typically, that's a steroid. The market looks something like this. There are about 81,000 adult chronic ITP patients in the U.S.. A portion, 37,000 or so, are in watchful waiting. Now, these may have some milder form of disease or in some transient remission for their disease. Eventually, they need something else. First line is typically a steroid. About 20,000 or so patients are maintained on steroids, but then they need something beyond that, typically. In the second line and after, it's about 24,000 patients in the U.S.. As you see here, they are arrayed this way, with the majority of those in second and third line, about 75% of those patients there, and then more refractory lines, fourth and fifth line, as you see there. When we launched the product, primarily we were used in more refractory cases, which is not surprising. Doctors are used to treating ITP in a certain way, and then they added you when the products they were most familiar with didn't work, more refractory lines. Our objective has been to get into those earlier lines, second and third line, and I'm happy to report that we have succeeded. Over 70% of our patients are in second and third line now. Tremendous progress in getting into that direction. 1, that's where the patients are, so we want to be there. Importantly, on slide 7, the earlier you treat, the better your results are with our product. So the patients that are in second and third line there have really excellent, excellent response rates, better than in the fourth or fifth line, though it works quite well there as well, as you see from this graph. So delighted that we're moving there. That's where the patients are, and that's where the patients are more likely to succeed. So as a result, when a doctor puts the patient on second and third line on our product, they're highly likely to have a good response, which means they're highly likely to use it again in that line, and frankly, an earlier line. Over time, you build that confidence in the doctor community, and they use it earlier and earlier and get used to using it, and that's what builds a business, and that's what we're seeing now, and I'll tell you a little bit more about that trajectory. Second key point here is once we get a patient to succeed on our product, generally we maintain that success, and that's been proven by many months on follow-up of patients that we had even in our clinical trials. So if you get a good response, you generally tend to keep the response, which is a great result for the patient. Here's some interesting things that I'd like to share with you. On the left side there are patient starts for the quarter, per quarter and by year. So we launched the product. We did really well in the first year and a half, and then something called COVID hit in 2020, and things just flattened out there. Our. We had to pull our sales reps from the field, and basically, patients were not out there looking for new treatments during that COVID two years, 2020 and 2021, as you see on this graph. Then something remarkable happened in 2022. All that changed. Our reps were able to go out and discuss the product and our data with doctors. Patients were now out there looking for new treatments 'cause they were frankly not doing that well when they were ensconced at home. And the results is substantial growth in new patient starts, which is the leading indicator of demand bottles and sales. And so we've seen 2022, 2023, and now in 2024, very nice growth in new patient starts and in sales and in demand for our products. So really fantastic there, and it's really driven by continuing focus on reaching these new patients and making sure the doctors know our data proximate to the doctors making a decision to switch a patient to a new therapy, 'cause we have a very compelling argument for that. We have very good reimbursement coverage, over 95% commercial insurance, and really the data that supports the use of the product substantially. So Q4, Q1 of 2024 was our best quarter ever in terms of patient demand. So a very good trajectory for the product overall. Outside of the U.S., 'cause we only focus on the U.S. with our products, we have very good partners in place. In Europe, we have a partnership with Grifols, and they sell through all the major countries in Europe. In Asia, Kissei is our partner, and they launched in Japan after doing a very nice small confirmatory trial there, and are doing quite well in that market. We have partnerships with Medison and Knight Pharmaceuticals as well in other territories. Now, moving on to Rezlidhia on slide 11. Rezlidhia is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia, who have an IDH1 mutation. You may know this, but I'll remind you, AML is really an awful disease. It's aggressive, highly complex, evolving rapidly, affecting primarily older adults. Patients, about 20,000 patients a year, about 11,000 deaths a year. A really unfortunate consequence, and, you know, progress here is there, but boy, it's still an area of tremendous medical need. 69% of AML patients are IDH1 mutant patients, and that's where we have a product that addresses them. They're well-identified, they're generally genotyped, especially in the relapsed and refractory setting, and a significant need exists for better treatments. We're indicated for relapsed refractory, which is the orange bars here, in both fit and unfit patients with IDH1. And here's the basis of the approval and the data that supports this product. This is conducted by the product - the company from whom we licensed Rezlidhia, that is Forma, now Novo Nordisk. They did this very nice, comprehensive phase II trial, looking at Rezlidhia in monotherapy in a variety of different settings, as well as combination settings with azacitidine. The Cohort One group is the cohort that is the basis for the approval in relapsed refractory, 153 patients. Let me tell you a little bit about that here, 'cause it tells you why we were excited about this product. The Rezlidhia CR/CRh rate is about 35%. A little better maybe, but comparable to, to others in the, in this category. But what was most impressive is that if you had a response, the durability of that response was nearly 26 months. That's tremendous in a disease that is so rapidly progressing and is really so deadly. To say we can give you 2—more than 2 years of response if you achieve it, is fantastic. Furthermore, the quality of the response was actually quite good. 92% of our CR/CRh responders were actually CR responders. That is fantastic, and the durability there, a little bit better, 28 months. So very good data supporting the use of this product. We're excited to have it and excited to do more with this product beyond relapsed refractory AML. So I wanted to... We acquired the product, we had the approval early, and we launched the product in very late 2022, in late December of 2022. So really, it's been on the market all of 2023 and then the first quarter of 2024 here. What you see here, and we've divided this in institutional sales patients, as well as clinic community patients. The majority of the patients are in the institution side, which shouldn't surprise us. It didn't surprise us at all because those are the doctors that adopt the product earlier and new technologies first, and then eventually it bleeds into the community centers once they see their colleagues in the academic centers using this product or a product like this in a more commonplace. So to help sell this product, we took a portion of our sales organization, created an institutional business team. About eight sales reps who focus on academic institution centers in the U.S., as well as a community sales organization, continued that sell Tavalisse, as well as Rezlidhia in the community setting, about 47 or so of those sales reps. Together, they've generated this growth on a quarterly basis, primarily driven by institutions. But what we're expecting to see in the future is that the growth will continue in institutions, but the growth will substantially be in the community setting. We think about half the patients are treated in community settings, the other half in more institutions. So we expect in the long term, these two bars to be roughly comparable. And you see, you're beginning already to see a little bit of that. In Q1, 25% of our patients came from community settings. So that's an early indicator of where patients and bottles and sales are likely to be. Significant opportunity here, particularly because the treatment paradigm for AML is venetoclax and something like azacitidine, VenAza. In the post-ven setting, which is what this is in the relapse to that, we have really very nice data. We presented it at the ASCO meeting just a week ago or so, and you're welcome to look at the those posters. But very nice data that our product works very well in the post-venetoclax setting. I think that'll help us penetrate the community setting and continue to penetrate the institutional setting as well with Rezlidhia. We're. I'll tell you a little bit more in a minute about what we're hoping to do with Rezlidhia going on beyond relapsed refractory, 'cause that's very exciting. I'd like to tell you a little bit about Gavreto, which is a RET fusion-positive drug for non-small cell lung cancer and thyroid cancer. It's indicated for adult patients with non-small cell lung cancer with a RET fusion mutation, as well as adult and pediatric patients with thyroid cancer with a RET fusion mutation as well. We acquired this product from Blueprint Medicines. They had licensed it to Roche Genentech, who had been selling it since launch, and they decided that that wasn't a fit for their portfolio, and they looked to sell it. So we were like delighted to acquire rights to this. It's a once and only, the only one that is a once daily oral small molecule inhibitor of RET and RET mutations. Highly synergistic to the Rigel sales organization. You know, we were selling hem/onc products with Tavalisse and Rezlidhia, but when we looked at our sales organization, what we saw is that 80% of them had solid tumor experience. And in fact, something over 50% had lung cancer experience specifically, on average, two years plus. So we had a sales organization; it's very experienced, that not surprisingly, had sold solid tumors and had sold lung cancer products specifically. So when we had the opportunity to acquire this product, we were really excited about it 'cause we know and already have some of those relationships built to help us sell this product effectively. Last year, Roche/Genentech generated about $28 million in sales, and patents that go on to 2036 and 2041. The deal economics, very nice, $15 million in upfront. The first 10 of that, when we do our first commercial sale, we think that'll be in July, next month, and then $5 million a year after closing. Then there's milestones and regulatory royalty payments in addition to that. We think we'll start selling it, and the plan is to sell it beginning in July, a month from now. So delighted to have this product as part of the portfolio and selling it throughout the organization. Here's where we see some of the opportunity here. It's a well. You know, as you may know, genotyping is becoming more and more commonplace across all of cancers, and especially in some solid tumors, such as this, where RET is well-identified as a mutation. Doctors are aware of the RET and aware that there are products to treat RET. That's already a really good place to start. We have a very good patient access organization that we think we can make this product available to a large number of patients that have this unfortunate disease through our Rigel OneCare Patient Services Center. It's very complementary to what we are already selling in terms of that. We may add a few people to the company because of this, but it's not a substantial. Here's where we see the opportunity. On the right side there, there's another RET inhibitor, and it's the predominant one. We have Gavreto at about 50% of the market in this first line RET fusion non-small cell lung cancer. But the opportunity is in the multi-kinase inhibitors here in black and the chemo and immune checkpoint inhibitors here in gray, that are treated with those agents. But unfortunately, those agents do not generate very good results. So if we're able to share the data on Gavreto, which I'll share with you in a minute, with those clinicians, we think it'll be compelling, and we think we could take share from the MKIs and the chemo, immune checkpoint inhibitors as a way of growing the business. And we're excited about that opportunity because it's a compelling argument, and we think we have the people to make it. Here's some of the data. It's called ARROW study, which is the basis for approval for the product, and it's been published as well. And in RET fusion non-small cell lung cancer, about 260 patients. In patients that were pretreated, we saw response rates of 63%. If they were naive, even higher, 74% and 80%. In thyroid cancer, excellent result, 91% response rates. And in other solid tumors, there were quite a range of them, an overall response rate of 57%, some very, very high and some a bit lower in that area. So we're excited about the data because we think the product has shown very nice response rates and importantly, durability of those response rates. So here's the proposition for the product. It's the only once-daily RET inhibitor indicated for non-small cell lung cancer and thyroid cancer, high and durable responses. It's a targeted therapy, and we like that. So you're beginning to see some consistency here across our various products. You study brain mets in this case because you see if you were able to, address that, and frankly, we've seen very nice results there. Safety and tolerability is very good, and we think it's a very good treatment option for these RET-positive lung cancers, non-small cell lung cancer, as well as the, thyroid cancer patients. What we've done, we, we assigned this collaboration, this, acquisition early this year, and then began preparing our organization and our set distribution network to accept this product into our portfolio in Q2. In July, when we take it into our portfolio, we'll begin, promoting these, this product to current users as the main focus, to make sure that if a doctor is using the product now or a patient is succeeding on this product, to make sure they stay on the product. That is paramount, and we're working hard to make that happen. And our whole company is focusing on succeeding with that because we want to make sure if a person, a patient is succeeding on Gavreto, they continue to do so and have the opportunity to do so. So that'll be our focus in July in Q3. In Q4 then, we're going to expand and begin addressing non-users, which we see as a real opportunity as well. The awareness of our data is not where we want it to be as yet. We'll change that. And importantly, the primary reason doctors are not using our product is simply that they're familiar with other products. But we have to be in front of them, and we have the organization and the message, I think, to succeed with this product, beginning in Q4 and beyond. So we're excited to have it as a part of our portfolio. It's a logical progression. So we had Tavalisse. We built a very nice commercial hemonc organization. Then we added Rezlidhia to that. Maybe we added one person to the organization to do that. And then we added Gavreto to that. We added maybe a handful of people to the organization to do that. And you begin to see, if you can imagine, the top line growing substantially, the expense line growing, but much, much less so. And so it gets us to where we want to be. That is a company that is going to reach break even in the very foreseeable future. And that's exactly what we want to be, because generating cash in that position will then allow us to do a good deal more. What is a good deal more? We're looking to grow the company in two different ways. One is continue in licensing and product acquisition. Just like with Gavreto and Rezlidhia, we're looking for differentiated assets in hematology, oncology, or related areas. By that, I mean something like transplant rejection, which many doctors overlap between that. And we're looking for late-stage programs. That is, programs with registrational data, or the NDA has been filed, or the NDA is approved, or the product is launched and marketed. A wide range of different places. As a next step, we may begin looking at some earlier products with data coming in the near future as a possibility. And importantly, it has to be synergistic with the capabilities we have in-house. We've built a nice organization with tremendous capabilities. The sales group, I mentioned two sales forces, the institutional and community. We also have an excellent medical affairs area, an excellent market access team, a marketing organization, and a business operations team that really are capable of selling all of this. Of course, we also have a manufacturing group that uses CROs to make these products, and they've all the requisite things like compliance and legal to help us sell this product, these products. So we're looking to build on that, and we think we can continue to build and add additional products. And because we have an existing organization to sell them, they very quickly become accretive, and that's what we're aiming to do. That cash generation in the long term will help us work on what is on the left side. We'd like to develop further, particularly olutasidenib, which has potential in a broad range of IDH1 mutant cancers. First-line AML, for example, is a real possibility; a product's approved there. MDS is certainly a possibility; products are approved there. And probably the most compelling opportunity is in glioma. I'll tell you a little bit about that as well, 'cause I think that's an exciting possibility. And then our IRAK1 and 4 inhibitor, I'll tell you a little bit about that as well. In low-risk MDS, that's a tremendous opportunity for us to go forward with. So last year, late last year, we put in place a couple collaborations. I'd like to tell you about them. One was with MD Anderson. MD Anderson is the one of the world's premier cancer treatment organizations. They pride themselves not on giving you the standard of care today. In fact, their objective is to create the standard of care of tomorrow. They were very excited to work with us in a broad strategic alliance based on olutasidenib or Rezlidhia. And they were excited about it 'cause they think that this product, in IDH1 patients, could be central to the standard of care of the future. And they were excited to help us make that sell and us to work with them in making that the case. And so we're working on them in this collaboration, where we're gonna study olutasidenib in four different, and maybe more, areas. One is AML, particularly first line. I think that's exciting because beginning to define the use of the product there could be very, very attractive, especially as new HMAs take the place of azacitidine. In higher-risk MDS is another area where there's a real potential here, and I think this product could show real benefit. Then there's a lower-risk MDS and CCUS, which is an area where we're excited about, and so are they, in terms of trying the product, and in post-transplant maintenance. So excited to do those things. It's a $15 million collaboration over 5 years, $3 million a year or so. Very cost efficient and very time efficient to getting things rolling. We hope to start most of these collaborations this calendar year and report those to you. We did the same—I'm gonna rush a little because I'm noticing the clock catching up with me. We're also excited about a collaboration we did with the CONNECT organization on glioma. As you know, glioma is just a terrible thing. High-grade gliomas, we've done very little to help these patients. About 800, 1,000 patients in adult adolescence, with higher-grade gliomas, we've demonstrated with our product, with olutasidenib, that we have an impact on highly refractory patients with gliomas, and that data's published. What we showed was that we're able to help those patients achieve stable disease, which is a very good result. Now, we're looking to do much more with it, with this CONNECT organization. They have an umbrella trial that's already recruiting patients across the U.S. in high-grade glioma, and we're adding our product onto that. So the startup is already done. So quickly, we can start enrolling patients in an arm devoted to IDH1 mutant gliomas and to help generate data for this in the future. So we're really excited about this collaboration. It's $3 million over four years. Again, time efficient, cost efficient in getting data in high-grade gliomas, which is an area of major opportunity and, and major ability for us to add value. I left this slide in simply 'cause I want to point out what's in the bottom of this slide. Despite multimodal treatment therapies in adolescents and young adults, each year in patients with high-grade glioma, the results are dismal. Less than 10% survival five years, that's terrible. And if we have an impact on those IDH1 patients with high-grade glioma, I think that'll be a tremendous advancement for these patients and frankly, a tremendous opportunity for us as a company. Let me tell you a little bit about our IRAK1 and 4 inhibitor in the last few minutes. It's a inhibitor that inhibits both toll-like receptor and IL-1 receptor, two key inflammatory pathways. Low-risk MDS starts with a pro-inflammatory environment in the bone marrow, and this addresses that very deep, very profoundly. So we have some data in normal volunteers that we're able to reduce these pro-inflammatory cytokines, and we're excited to be doing this clinical trial. We've dosed dose group 1, 2, and 3, and we will be dosing group 4 and 5. We plan to have data on this program at the end of this calendar year, and we're looking for not only safety, 'cause that's the key one, but also signs of transfusion independence and other response rates here. We have a partnership with Lilly on our RIP1 inhibitor program. That's going well, and they have a phase II trial underway in RA. Financials, we're in good shape financially. You know, we've grown the product every throughout its period. Last quarter, we had a drop in inventory, which accounted for that dip there in Q1, but we expect this to continue to grow nicely the remainder of the year and offset that. We have about $50 million in cash, which is a comfortable position as we get to a point where we're consuming fairly little cash on a quarterly basis going forward. Our objectives are to continue to grow Tavalisse and Rezlidhia, to commercialize Gavreto, and then continued financial discipline to get to a break-even in the near future, and then fund these development programs for Oluta and MDS, AML and glioma, and for the IRAK1/4 inhibitor as well. With that, thank you so much, and I apologize for going a minute over.