Good morning, everyone. It's my pleasure to introduce Raul Rodriguez, CEO of Rigel Pharmaceuticals. This is a standard presentation, so go ahead, Raul.
Thank you for the introduction. Thank you to our Jefferies colleagues for having invited us. It's nice to be with you this morning. I'd like to introduce Rigel to you, but before I do so, just forward-looking statements. These are available on our website. If you would read those. Let me start by telling you what Rigel is, where we're going. We're a hematology and oncology biotech company. Here in this slide, we outline what our goals are. Our goal is to be a much larger company than we are today. I'll show you what we've been doing since the last handful of years to get to where we are today and what our plans are for the future. Really contained on this slide, and I'd like to address four different things. One, commercial execution.
We have a commercial business in the U.S. where we're selling three approved products for various hematologic and oncologic conditions: TAVALISSE, which is indicated for ITP. I'll tell you a bit more about that; REZLIDHIA, approved for mutant IDH1 relapsed and refractory AML; and then GAVRETO, our most recent acquisition, approved for RET fusion positive non-small cell lung cancer and thyroid cancer. These are products that we started with TAVALISSE. We subsequently have added REZLIDHIA and then GAVRETO, building a viable, larger commercial business. We've done so by looking outside for bringing those in. We continue to look at outside opportunities to bring in and add it to our commercial portfolio. I'll tell you a little bit more about that plan and how that's working. Couple that with financial discipline.
As we've added new products and grown our initial product, we've really not increased our SG&A line very much, the result of which is we are profitable. We turned profitable last year, and this year, through three quarters, we have been profitable, and that's our guidance for the balance of the year. Profitability. We would like to use the cash generation—we've generated $60 million in cash this year thus far—to develop our programs coming. Now, in the pipeline, our programs that are transformational, much larger opportunities, and opportunities where we own the asset and we can control its development. That's what we plan to do into the near future. I'll tell you about R289 in particular, which is in development for low-risk MDS.
You see here, we're growing by growing the base business, adding to the base business with new products, financial discipline so we get to profitability, invest that profitability in developing transformational indications that are in our own pipeline. Let me start by the first of those. Here's how the year's gone for us so far. I'd say very well. Last quarter, we sold $64 million in net product sales, which is a 65% increase from the same quarter a year earlier. Really impressive. You'll see that this year, at $166 million over three months, is already larger than all of 2024. In fact, $64 million, this performance for this quarter, is larger than all of 2021. Really dramatic growth, driven by TAVALISSE and driven by the addition of those two new products, REZLIDHIA and GAVRETO. Individually, they've all done well.
As you see here, TAVALISSE, $44.7 million in net product sales last quarter, a 70% increase from a year ago. GAVRETO, we acquired; it was selling about $7 million a quarter when we acquired it. Genentech had been commercializing it in the U.S. We're now up to $11.1 million. Really impressive results. And REZLIDHIA, $8.3 million, 50% growth from a year ago. All three products growing very nicely and contributing substantially, including TAVALISSE, our largest product. I'll take you through that. TAVALISSE is indicated for adults with chronic ITP, immune thrombocytopenia. These patients have an immunologic condition where their own bodies destroy their own platelets. It's an autoimmune disease. They suffer from low platelet counts as a consequence and live in constant fear of even a small cut can require an emergency room visit.
The goal of therapy here is to get patients above a certain threshold, typically 30,000 or 50,000 platelets, in order so they can clot normally. Here is the market in the U.S. They have about 81,000 patients with adult chronic ITP. 37,000 of them are watchful waiting. Eventually, they will need something, but they clearly have very low platelets. A normal person may have 200,000-400,000 platelets. People with ITP have 50,000 or less. First line is almost always a steroid. That is very typical. We are indicated for second line and beyond, about 24,000 patients, as you see from this slide, many of them in the second and third line. When we launched the product, we were primarily used in the more refractory fourth and fifth line.
Smaller patient populations, as you can see there, a class of agents called TPO mimetics were used earlier, and Rituxan was used. Those are the two most commonly and well-established agents when we launched. In fact, they were available more than 10 years before we launched, so well-entrenched. We launched our product with a new mechanism, and it's taken a while, but now I can say we've succeeded in getting doctors to use it across all the lines of therapy. That's been great because the numbers are larger in the second and third line, as you see. Importantly, the earlier you use this product, the better your results are. As you see on the left here, if you're in fifth line, 50% response rate is what you might get. If it's third, 86%. If it's a second line, 94% response rates. The earlier you use it, the better.
As doctors have become more familiar with the product, succeeded in later lines, they now begin to move it up. We do pretty well in third line and even some doctors in second line. That is fantastic because responses are higher, populations are higher. Importantly, on the right side of this slide, the durability is very good with this product. If your patient is succeeding with the product, you generally tend to continue to use it and continue to succeed over the course of many months, years, actually. It all builds on itself. The product, even though now it is in its seventh year of being in the market, continues to show really good growth as doctors become used to using it and across all lines of therapy and getting better and better results, creating, you know, again, they want to use it in more patients.
This has been a tremendous success for us and a great agent to build the subsequent products upon. Let me talk about the next one. REZLIDHIA is indicated for mutant IDH1 relapsed and refractory AML, as you see on this slide. Now, AML is just a terrible disease, I have to say. About 22,000 patients are diagnosed every year, about 11,000 deaths a year from this. Really, really horrible. About 6-9% of patients have mutant IDH1 mutations. That is what we focus on here. In general, they are well identified. They have been genotyped so that they say, "This is an IDH1 patient," and we could provide a drug to them. Let me show you on the next slide why we were excited about this drug. Generally, an elderly population was studied, typical of people with AML. They tend to be older, older patients.
A response rate of 35%, CR/CRh, was really impressive to us. We had over 25 months of durability of that response. Other agents in this category, much less than that, under 10 months durability. Really impressive results there. Most of our responders were CRs rather than CRhs. Again, they even had a longer duration of response. Pretty exciting data that I think, you know, our thinking is we provide this to doctors, they'll note the benefit, and therefore they'll use it more and more so. We licensed this product from a company named Forma, now part of Novo Nordisk. We've done well with it thus far. Our third acquisition is GAVRETO. GAVRETO is indicated for RET fusion positive non-small cell lung cancer or thyroid cancer in adults, for lung cancer in children and adults, and thyroid cancer. Here's what excited us about this opportunity.
RET fusion inhibitors occupy about 75% of the market. There's a Lilly product that's larger than ours; they had launched earlier. GAVRETO was launched, acquired 15% of the market. The opportunity here is in the gray areas, the multikinase inhibitors and the chemotherapeutics and immune checkpoint inhibitors that are used. Those do not deliver nearly as good a result as RET inhibitors do. The goal is to build the product by eating into the gray bars. Substantial opportunity for GAVRETO and for ourselves. We were excited about the product's ability to be an oral daily agent, the only one available for both of these indications, highly durable responses, and, you know, very good safety and well tolerated. The guidelines shifted earlier this year in our favor. It's recommended that patients now with small, non-small cell lung cancer use a RET inhibitor.
The guidelines have shifted in our favor. In fact, recommendation is even if a patient is succeeding on a multikinase inhibitor or chemotherapy, to change them to a RET inhibitor as a preferred approach. It helps our whole sector, ourselves and the other RET inhibitor. I think this is really a good tailwind for us. As a result, we've been able to grow the brand nicely, as I mentioned, from what used to be $7 million a quarter to now $11 million. We focus primarily on the U.S. market. Outside the U.S., there are very good opportunities, but we think it's better there to use partners that already have established capabilities there. For TAVALISSE, we've partnered the product with Grifols in Europe and Kissei in Asia and Japan and Medison in a couple other territories.
They've gotten the product approved in their main markets and are expanding that continuously. We now have approvals in both Korea and Mexico. We are now doing similarly with REZLIDHIA. It's a bit earlier on, but we've already done some of our first partnerships with Dr. Reddy's and Kissei. Let me tell you about the pipeline, because I think that's perhaps one of the most exciting things about this story. Let me focus initially on in-licensing. We are looking to continue to in-license differentiated assets in hematology and oncology. That is, assets where we think we could add substantial value. Late-stage assets, what I mean by that is something with registrational data already in hand. We don't want to have to do a trial to get it on the market.
No, we want the data in hand, or the NDA has already been filed, or the NDA is approved and it is waiting to launch, or it is already launched and for some reason the product marketing does not fit with their portfolio. GAVRETO is an example of that. We are looking that they have to be synergistic with our in-house capabilities. We do not have to add a lot of infrastructure to sell these new assets. You can imagine the impact on our P&L. You add a product on the top line, you spend very little increment in terms of what you are spending on the SG&A line. Much of that drops to the bottom line, resulting in a highly accretive product and pretty early on in its life cycle, allowing us, in turn, to invest more in our own transformational opportunities in our own pipeline.
We've been very active here and continue to be. We hope to in-license one or two additional molecules in the next handful of years. It's a key effort for us. What's exciting also is the development pipeline. I'll focus on 289 and our IRAK1/4 inhibitor as a key asset and discuss olutasidenib as well, which is REZLIDHIA. It's the generic name for REZLIDHIA, which we're proceeding with numerous collaborations and perhaps our own trial. 289, our IRAK1/4 inhibitor. This is what the market for low-risk MDS looks like. MDS is a disorder of hematopoietic stem cells that lead to ineffective hematopoiesis. These patients are highly anemic. They require transfusions on a regular basis, sometimes every couple of weeks even, in order to have normal hemoglobin levels and not feel tired and anemic, frankly.
The primary goal is to take those patients that are transfusion dependent and get them to transfusion independent as a measure. The agents available now are listed here, and frankly, there's room for substantial improvement. First line is typically an ESA, an erythroid stimulating agent. Failing that, you go on to a product like Luspatercept. That's the main agent in this category. Last quarter, it sold $500 million, en route to becoming a $2 billion product. Imetelstat, that was approved from Geron last year. Now, both of these agents deliver roughly 38% or 40% response rates. It's not extraordinary by any means. Failing that, the options become even worse. HMAs are approved, and they deliver 18%-20% response rates. Really very poor. For patients after that, there frankly is nothing.
It's a category with substantial opportunities, but yet the agents that are approved have some serious issues or lack of efficacy in many cases. We view all of these areas, from highly refractory to post-Luspatercept to post-ESAs, as key opportunities for us. The ones on the left are tremendously large, and that's what we want to do, where we want to go forward with 289. Here's what got us excited about this opportunity. About 12,000 patients with lower-risk MDS that had previously used some other agent, good-sized patient population. As I said, lacking in options for some of these patients. The mechanism of R289 in low-risk MDS is so perfect in many ways. The inflammatory cascade that happens in the bone marrow, effectively a cytokine storm in the bone marrow, is what causes this disease, and that pushes out normal hematopoiesis.
It's thought that blocking toll-like receptors and IL-1, which is what IRAK1 and 4 inhibitors do, are key to restoring normal hematopoiesis. I'll show you a bit of a clinical concept study that we did in normal healthy volunteers in just a second. The regulatory agencies have given us a fast-track designation and orphan designation. Clearly, they view this as an opportunity for improvement in this category. I'll share a little bit of data, but, you know, initial data has been very, very excellent in terms of its safety and efficacy, albeit limited as yet in terms of numbers of patients. Let me show you the results of that one clinical study. Here, you take healthy volunteers. You give them an LPS challenge. This causes a cytokine storm. This is done in a hospital setting, so these patients are fine. Then you give them R289.
R289 is a prodrug of A35. In normal circulation, A35 is what circulates. R289 converts to A35 completely in the gut. Think of the two as interchangeable. What you see is A35 is able to substantially reduce the inflammatory cytokines in these individuals in a dose-dependent manner. Our thinking now, this is an artificial condition, we created it, we resolved it. If we could do this chronically in a disease like low-risk MDS, where it is an inflammatory condition that is central to the development of that disease, we ought to have a benefit. There are other diseases with this characteristic, by the way, but low-risk MDS is one of those that is incredibly attractive. We went ahead and launched this study. It is a phase 1b study. It has a dose escalation phase and then followed by a dose expansion phase.
We've completed the dose escalation phase. At ASH last year, we shared data on dose level 1, 2, 3, and 4, showing some very nice results, about three out of 10 responders. Now we're going to show data at this upcoming ASH on dose level 5 and dose level 6. Dose level 6 is 500 milligrams b.i.d. What we've done also this year is we selected two of those doses, 500 q.d. and 500 b.i.d., to go forward into an expansion phase where we do up to 20 patients on each of these. This is enrolling now. Our plan is to have data from the expansion phase a year from now. Imagine then we'll have 20 patients on each of these dose groups, which is really enough to say something meaningful about it. Right now it's five or six, which is good.
But when you have 20, you can actually say this is a product. What we plan on doing is initiating a registration study in 2027, obviously interacting with FDA and helping us design that study. The key feature of this is taking patients from transfusion dependence to transfusion independence. It is pretty straightforward. We will take one of these two doses forward into a registrational program. We are also going to launch an exploratory study in the post-ESA market, the earliest phase of those as well, to show the benefit in that patient population. That is an exciting year coming. It is exciting to have data in about a month, three weeks from now at the ASH meeting. Some of you are there. It is an oral presentation. Let me go to that slide. Let me just, it is an oral presentation that is going to be on Saturday morning by Dr. Garcia-Manero.
He's one of the PIs in the study. We'll present that at the ASH meeting. We've completed enrollment, and we're going to complete enrollment in the expansion phase of the study and choose a recommended dose for registrational studies. We'll share that data at ASH probably next year or end of next year, and then work with FDA to launch that registrational study as the next step. Let me go on to Olutasidenib and some of the work we're doing there. We've put in place this alliance with MD Anderson, one of the world's premier cancer research and treatment centers. With them, we've launched five different studies studying Olutasidenib in a range of indications, AML, refractory, but also first line, where we don't have an approval there. We'd like to study in that segment because it's an attractive one.
In high-risk MDS, CMML, and other NPM, we also are going to be studying it in CCUS and lower-risk MDS as well in the post-transplant setting, which is a really interesting one, and then in combination with other targeted therapies. It is a range of different conditions with IDH1 mutations that are very difficult to treat. I think really exciting new areas for the product, as well as generating data supporting even the approved indication. In addition to that, we are working with the Connect organization. Now, IDH1 gliomas are really an interesting area where there have been some advancements with IDH inhibitors. We'd like to explore the opportunity with Olutasidenib in this category. About 29-35% of CNS tumors are gliomas, so sizable numbers. The Connect organization has launched an umbrella study called Targeted Study, studying high-grade gliomas across the U.S.
Working with us, we've now added what is called the Targeted D phase two arm of that study, where these are patients that are newly diagnosed and they're given TMZ, Temozolomide, and Olutasidenib for a year, and then followed with just Olutasidenib for a subsequent year to see how their disease progresses. It's open for enrollment now. We look forward to having data on this because it's a really exciting opportunity. We've also just announced a collaboration with MyeloMatch. MyeloMatch is an NCI-sponsored group that's looking at precision medicines for AML and MDS. They're working with us on AML in first line, again, an indication we don't currently have, but a really attractive opportunity. They have the resources and funding to do larger trials. This will be very exciting once we finalize this and are able to launch this. This is what's happening at the ASH meeting.
We have an oral presentation on R289 on Sunday, sorry. Then we have four poster presentations on Olutasidenib in various patient populations that are very interesting, particularly one with Venetoclax, which is the common agent that's used in this category in the post-Venetoclax setting. I will move quickly to this program that we have partnered with Eli Lilly. It's a RIP1 inhibitor program. The main focus is immune diseases. The lead molecule, Ocadusertinib, is being studied in a phase two clinical study for rheumatoid arthritis. It's an exciting area because, as you know, rheumatoid arthritis is a huge area. TNF inhibitors, JAK inhibitors are billion-dollar drugs, multi-billion-dollar drugs. This might be a successor to that category. When we had this agent, we thought, who would be a really good partner for this? Eli Lilly obviously is that.
They have the resources, the focus to really focus on this and move it forward. They will complete this study, and we will get excellent remuneration if it succeeds, milestones and royalties. Let me move to financials. We've grown the business substantially, as you see on the right here. And our partners, via collaboration revenues, have contributed nicely to our success, and we look to continue that. Sorry for the small print here, but I wanted to point out a couple of things. Last quarter, we generated $27.9 million in net income for the year, substantially more. We generated $60 million, roughly, in cash for the year thus far. We are cash generating. In addition, we've raised our guidance to $285 million-$290 million in revenue, of which $225 million-$230 million is net product sales, the balance being revenue from collaborations.
We, again, reiterated our guidance that we will be net income positive. It's pretty obvious, if you look over there, that we are going to be. In addition to that, fund the clinical trials we want to do. That's what we want to do. Use the cash we're generating ourselves to fund transformational programs. You'll see the SG&A line, I mean, sorry, the R&D line continue to increase over time as we launch more and more trials for 289 in particular. You know, impressive chart. Great growth. Three years of coming out of COVID, 32% growth on average. That's fantastic. We're guiding to 55-59% growth this year. Again, outstanding performance on the commercial side, allowing us to do all the things that we want to do.
Continue to grow the commercial business, add additional products to the commercial business, financial discipline, allowing us to generate increasingly larger amounts of cash, plow that cash into the development programs to generate transformational opportunities led by 289 and low-risk MDS and other hematologic indications where inflammation is a key component. It is a very strong strategy. We are executing well on the strategy, and we really like where we are across all these areas. Sorry, that took a little longer than I expected.