Good morning, everyone. Thanks for joining us on the final day of JPM this year. My name is Richard Mayland. I'm with the banking team here at J.P. Morgan, and it's my pleasure this morning to introduce Rigel Pharmaceuticals. Presenting today, we have President and CEO of Rigel, Raul Rodriguez. We'll have some time for Q&A after the presentation, and with that, I'll hand it over to you, Raul.
Thank you, Richard. And thank you to our colleagues at J.P. Morgan for having invited us today. It's a pleasure to present at your conference. And again, thank you for a very nicely organized conference and for scheduling the good weather, too. Appreciate all of that. So here are some forward-looking statements. They're very important for you to read. They're available on our website, so please read these. They're pertinent to this presentation. So Rigel is a hematology and oncology company. And we've worked very hard over the years to grow this company and make it substantially more. 2024 was probably our most important and really truly a transformational year for the company. And I'd like to tell you in this presentation why that's the case and why it sets us up so well for what's coming next in the future as we continue to grow our company.
There are a couple of things on this slide that I'd like to take you through briefly in summary and then go into considerably more detail over some of them. The commercial business comprised of now three approved products for different indications, and I'll tell you about each of these in turn, but this has been a core component of the company that we've used to grow the business substantially. I'll share that with you today. Importantly, we're growing this business by not just expanding the growth of each individual product, but by adding products as well. Rezlidhia was in-licensed, and then most recently, Gavretto was acquired. We acquired U.S. rights, so in-licensing and acquisition has been central to the growing of the commercial business. That growth of the commercial business, coupled with financial discipline, has allowed us to do something really remarkable in biotech.
That is, turn the corner and start generating cash. That's a fantastic place to be for a company like Rigel because now, instead of relying on other sources of cash, we're generating our own cash. In fact, our cash position improved by about $20 million from end of year 2023 to end of year 2024. And we see that continuing into the future. However, it's just not that. We don't want to create cash. We don't want to be profitable for the fun of being those things. Those are good things to be, though. It actually is because we have some really important opportunities that we want to move forward with. And now we can do that. Two opportunities on the development side that I'd like to highlight and discuss with you in some length in this presentation.
One is R289, our dual IRAK1 and 4 inhibitor discovered by Rigel and currently in a phase 1B study in lower risk MDS, and second, being olutasidenib, one of the in-licensed opportunities, Rezlidhia, that we'd like to move beyond relapsed and refractory AML to other opportunities which are quite meaningful, especially glioma, so you put all of this together, the company is truly a pivot point at this point. Growth of the commercial business, reaching financial breakeven and the future profitability, having important things to invest in that in turn will take the company to the next level. These opportunities that we're going to discuss are opportunities where there's truly a major medical need and where these opportunities may, in fact, meet some of that need, so we're delighted to have the means and wherewithal and strategy to move those forward.
I'll start with the commercial side of the business first and then take you into the development programs in a second, so first, let me just say a word about the sales of the company, which I said really remarkable. This year, we achieved $145 million in sales, just about. Every quarter this year was better than its comparator quarter a year ago, as you see from this chart. Q4, in particular, 58% growth in this quarter over the same quarter last year. Really a remarkable growth in the business overall at $145 million. That's about a 38% growth overall from the top line for the year to year. Really impressive growth. You'll see from our guidance we seek to continue that growth going into the future, and I'll share with you why.
Tavalis fostamatinib is indicated for the treatment of adult chronic ITP, immune thrombocytopenia, for patients who have an insufficient response to a prior therapy. ITP is an autoimmune disease where the body destroys its own circulating platelets. These patients suffer from very low platelet counts and in constant fear of bleeding. Bleeding becomes a major episode, maybe requiring emergency room visits to stop it. What Tavalis fostamatinib is able to do is dampen that autoimmune destruction process and therefore allowing platelet numbers to rise so they can lead near normal lives. It was an important contribution to the treatment of ITP. This is, as I mentioned, a Rigel discovered product, our first product, and we were able to launch it in 2018.
Since 2018, we've grown the product substantially, this past quarter reaching $31 million in net product sales, which is really an impressive continued growth, as you see here, 21% growth in sales over the same quarter last year. Growth in bottles directly to patients in clinic this quarter, a record quarter in terms of bottles shipped to patients in clinics, and a record quarter in terms of bottles sold to the market. That includes the impact of inventory. We had some inventory increase this past quarter, which is typical of Q4s in our sector. Our second product is Rezlidhia, olutasidenib. Rezlidhia is indicated for the treatment of adult patients with acute or refractory AML with a susceptible IDH1 mutation. This is a product we in-licensed from Forma Therapeutics. We in-licensed it. The product had already had its NDA filed. We helped manage the NDA to approval.
And then we launched the product. So it's been on the market in 2023 and 2024, available to patients. And really has performed very nicely for us. It's still in its launch phase. And so you see here, $7.4 million in sales this past quarter, of impressive growth over a year ago. But that's to be expected because this product is still launching and still being made available to new patients. There's a fair amount of growth here for this product as we continue to position it within this market. And we're really excited about the opportunity, not only in relapse refractory AML, but I'll share with you in a few minutes why we think this has potential in a wide range of other hemo-onc conditions and glioma, areas with significant unmet medical need. Our third product is a product named Gavretto.
Gavretto is indicated for the treatment of RET fusion positive non-small cell lung cancer and thyroid cancer. We acquired U.S. rights to Gavretto this year from our colleagues at Blueprint Medicines. Gavretto was being sold previously by Genentech and Roche in the U.S. They decided to return that product rights to Blueprint, and we were able to take on the product and keep the product on the market, so patients benefiting from Gavretto are still able to take this product. So we've had this product for only about six months. Genentech had been selling about $28 million a year with this product for Genentech, not a very impressive number, as you may surmise. But we were delighted that in our first full quarter of the product, in Q3 of this past year, we were able to achieve $7.1 million, effectively the same run rate that Genentech had been showing.
And this is impressive because usually when you transfer a product from company A to company B, there's leakage. Some patients don't continue on product. Sales drop. That's fairly typical for the first few quarters and then recover. Glad to say we did an excellent job with our friends at Blueprint and Genentech to be able to maintain all the patients that were taking the product and keep the sales level at about the same $7.1 million. Then what happened in Q4, you see here, is that we actually had new patients and new doctors taking the product. And this is, again, impressive because it's just barely new to us, but already we're sharing the data underlying this product with clinicians. And now our sales is $8.1 million. So we've already exceeded what Genentech had been doing in only our second quarter for this product.
So we really are delighted to have this as part of our portfolio. It's a product that meets a substantial need in this area and an area where we have very solid data to share with clinicians about the use of the product. So all three of these products are products that we're incredibly happy with. And we see continued growth. And I'll talk a little bit about that in terms of our guidance. Turning to the clinical development update. On this slide is how we're going to expand the portfolio. On the right is in-licensing and product acquisition. Like with Gavretto and like with Rezlidhia, we're looking for differentiated assets in hematology or oncology or related areas that are late stage.
By that, we mean we have registrational data in hand, or the NDA has been filed, or the NDA has been approved, or the product is already on the market. So effectively, we're looking for something that will be able to launch or in the market in the very near future, and that's important for us because we're looking for these assets to be accretive relatively shortly and contribute to the cash position of the company in the short term. We're also looking for products that are synergistic to our current sales capability and capacity. That is, we don't want to expand the sales organization greatly in order to sell the new products. We didn't have to do so with either of these two products. We added some headcount, but not very many.
As a result of that, the impact of these products on our P&L is substantial because much of that sales dropped down to the bottom line. And that's exactly what we want to achieve with future in-licensing and acquisitions. On the left side of this slide is how we're going to grow in a not incremental manner, but in a substantial manner, with the opportunities that you see here being potential game changers and truly transformational for the company. Two things I'd like to highlight. One is our R289, Rigel's IRAK1 and 4 inhibitor, which we'll discuss in lower risk MDS. And the second is olutasidenib, which we're looking at a variety of different things beyond AML. And we're looking to activate a trial in glioma this calendar year. I'll tell you a bit more about that.
With fostamatinib, we're putting in place a number of investigator-sponsored trials to help elucidate other benefits of Syk inhibition in the form of fostamatinib. Let's go forward with R289, IRAK1/4 inhibitor. This molecule was a Rigel-invented molecule. And here, I'd like to share with you the value proposition for R289 in lower-risk MDS. There are about 12,000 patients that are previously treated in lower-risk MDS in the U.S. However, despite the size of that opportunity, there is a substantial lack of effective therapies in this area. Really disappointing how little there is available that works well and works consistently. For example, HMAs are used frequently in this area. They were approved over 20 years ago. Response rate's about 20% only. So not very effective, but they're commonly used.
Other agents in this area have their own issues and their own deficits, which I think presents opportunities for us. It's a large area with substantial unmet need. What's interesting about this area, in addition, is in the last five and certainly 10 years, the inflammatory component of lower risk MDS has become much and much better appreciated as a key component of the pathogenesis of lower risk MDS. Effectively, it's a cytokine storm in the bone marrow is what best describes low risk MDS. And the results of that inflammation is that there is not normal hematopoiesis in the bone marrow, and cells do not differentiate normally. And you have immature cells, inappropriate cells. As a result, cytopenias, anemias, neutropenias are very common in this disease.
Our thinking is if we could address the inflammatory component of this disease, we may have a real benefit and a benefit that's very different in its approach from what's currently available. If we could block toll-like receptor signaling, TLR, and IL-1 receptor signaling, we may have a very active molecule. We have in R289 exactly that, and I'll share some information on this with you. A molecule that's very effective in blocking these two inflammatory signaling pathways. We've done a clinical study looking at this in normal healthy volunteers where we've given them a protein. I'll share the data with you, and showed we're able to suppress these inflammatory cytokines very effectively. The FDA has granted us Fast Track designation about a month and a half ago.
Then last month, or earlier this month, granted us orphan drug designation as well, sharing that they appreciate that there's a utility and value in moving this product forward in lower risk MDS. At the ASH meeting just passed, we were able to share some very promising but early data from a phase one B study in lower risk MDS. I'll share that with you here as well. Here's the treatment landscape for lower risk MDS. Again, MDS is a clonal disorder of hematopoietic stem cells leading to dysplasia and ineffective hematopoiesis. Initial therapies are erythropoiesis stimulating agents and transfusions. Now, those are not approved. They're in light green. They are simply to highlight they're not approved agents, but they're commonly used in the non-del(5q) area. Del(5q) patients are a small percentage of the overall population. Has an approved agent, as you see there.
Failing ESAs and transfusions, these patients typically receive the product named luspatercept. Or most recently, this past year, a new product was approved, Rytelo or imetelstat from Geron was also approved. Now, these agents have about a 40% response rate in this segment, but a fair number of patients that is not working for 60% of the patients. And then after they do work, many of them do relapse and require something else. What's currently used are the HMAs. A couple of these, azacitidine, decitabine, are used in the relapsed/refractory setting. The response rates are about 20%. So it tells you what a deficit of disorders, of treatments that are available in this category. If you fail an HMA, there really is nothing for you, nothing approved. You're resorting to experimental drugs, hoping something works for these patients.
So really, the lack of effective therapies in an area as large as this is really an important thing. And we happen to have a drug that may address something fundamental in this disease process. And that's why we're excited about trying it. Let me tell you why we're excited about our drug. IRAK1 and 4 address key signaling pathways, as I said, toll-like receptor and IL-1 signaling pathways. And interestingly, you need IRAK1 and 4 to provide more effective suppression of these IRAK signaling. If you only address IRAK4, there's compensatory mechanisms that IRAK1 allows you to still have an inflammatory environment. So you really need one and four. And I'll show you why one and four is better in a cell-based assay in a second.
If you're able to do this and you're able to do this in humans, and I'll show you the results of a human study, you're well on your way. By the way, R289 is a prodrug of our A35. In the body, A35 does all the work. There's complete conversion of 289 to A35 in the gut in a manner that's well established. Here's the cell-based assays I wanted to share with you and why an IRAK1 and 4 may be better than just an IRAK4. When this is a published IRAK4 inhibitor that's well studied in the clinic. As you see here, it inhibits IRAK4 nicely, but completely inactive against IRAK1. The result of that is that you get only partial inhibition of these inflammatory cytokines. With our molecule A35, it inhibits both IRAK4 and IRAK1 about equally potently.
You do get complete inhibition of these inflammatory cytokines. Now, you may ask, well, who else has an IRAK1 and 4 inhibitor? The answer is no one does. We're the only company in the clinic with an IRAK1 and 4 inhibitor. IRAK4s have been studied primarily for immune disorders, RA, psoriasis, et cetera, et cetera, but really very minimal effort in the hem-onc space or low risk MDS area. We're the only ones that have an IRAK1 and 4. It goes to the way we discovered the molecule using a cell-based functional screen rather than a biochemical assay that others have used. We're delighted to have this molecule because it is unique, and we think it's well suited to this indication. We took this molecule, and we put it into its first human study. Now, this is a study in healthy volunteers.
What you do is you give them an LPS challenge. LPS is a protein that causes a cytokine storm in the bodies of these volunteers. Now, this is done in a hospital setting, so everything is very safe, and then you test whether your drug at different doses is able to reduce that inflammatory cascade. The answer is, you see here, it's able to do so quite dramatically, reducing TNF, IL-6, IL-8, many other inflammatory cytokines dramatically. Now, this is an artificial condition. You created an insult. You solved the insult. We knew when the insult was there.
But if we were able to do this chronically, if we're able to give this drug on a long-term basis and reduce the inflammatory cytokines in a person who's suffering from that, say someone with low risk MDS, we may have a unique approach to treating low risk MDS that is fundamental to that disease process. And that is what we've begun to do with this trial. This is slide 20 now. R289 is a phase 1b study in relapsed refractory AML, lower risk MDS. And we started a dose escalation study here, beginning at dose level one. Frankly, too low a dose, but the FDA asked us to do that. Then 500 QD level two, 750 QD level three, dose level four, 250 BID. And then currently, we're enrolling dose level five. We may enroll dose level six at 500 BID as well. We haven't finalized that decision.
At the ASH meeting, we presented data from dose level one through four. What we're looking for is safety, AEs, and then secondary endpoints being transfusion independent. Most of these patients are transfusion dependent, and our goal is to get them to transfusion independence or have a hematologic improvement. That is a reduction in transfusions that's meaningful. Not surprisingly, we enrolled a very heavily pretreated population. About 77% had had luspatercept in the past. 73% had HMAs in the past, a median prior therapy of three. Mainly older people, that's who have lower risk MDS, and importantly, mostly high transfusion burden patients. As you see there, 73% had greater than eight RBC units in the prior 16 weeks, so a patient population that's very challenging and very difficult to treat that had failed almost everything available to them. The safety was well tolerated, low incidence of cytopenias and infections.
You see here on this slide, the 500 QD dose group, really just minor things here in diarrhea. A bit more things in the 750 QD dose group with increases in ALT and AST being perhaps a little bit more prominent. Really no issues with 250 BID simply because exposures were not at the high enough levels there. I'll show you that. So 250 QD, fairly low exposures, so not surprising that we didn't see much there. 500 QD, we did see higher exposures, and not surprisingly, we saw some responses. I'll show you that in a minute. At 750 QD, also higher exposures and also some responses. At 250 BID, not very high exposures, and not surprisingly as yet, no responses. And here's the data. As I mentioned, 250 QD was too low a dose, and we kind of knew that going in. We did three patients.
None of them responded, not surprisingly given the low exposures. At 500, though, we saw two responders, and here they're marked in little red stars and red diamonds, and what you see is that two of them responded, one actually really very nicely, so we have two of five evaluable transfusion dependent patients showing a response or 40% response rate. Patient nine on this chart was not transfusion dependent, so you really can't count that person. You can't get someone who's not transfusion dependent to transfusion independent, so two of five evaluable transfusion dependent patients showed a benefit. In the 750 dose group, something similar. You see two patients there, patient 10 and 11, showing our responses. Again, two of five transfusion dependent evaluable patients. One patient, 15, dropped out very early, so it was not an evaluable patient, so we're very happy that this is the initial result.
We've shared this with clinicians involved in the study, and they were really impressed with this data because it's remarkable that anything works with these patients, and given the high failure rate of other drugs, it's pretty impressive that we were able to achieve this. I'm going to show you this chart. This is the four responders we had in those two dose groups, and I'm showing this with you to highlight that all of them were high transfusion burden. One was a lower transfusion burden patient. Many therapies failed: ESAs, experimental medicine, experimental medicine, and HMA. In patient five, ESA, HMA, luspatercept, curiously fostamatinib experimental medicine in this indication, and an anti-TIM antibody. So quite a number of things that they failed, yet we were able to get them to a response, and that's really remarkable given this patient population.
It gave us considerable confidence and excitement about going forward. Here's the hemoglobin levels in these transfusion independent patients, three of them. And you see the hemoglobin levels responded quite nicely, as you expect to see, consistent with the results that we showed in terms of transfusion independent. But even the patients that were not responders in green here also saw increases in their hemoglobin levels as well. So there's clearly a benefit that is even beyond transfusion independent to these patients, but impressive results consistent with the earlier data shared with you. So in summary, the incidence of grade three, four cytopenias was low and infections was low. In patients that had 500 QD and 750 QD, they were able, which is higher exposures, we were able to show a benefit. About 40% of evaluable transfusion dependent patients in those two segments showed a benefit.
Some, including a durable responses, 24 weeks in a couple of these, and looking for more. There's still some of them are still ongoing. Patients achieving transfusion independence saw increases in their hemoglobin somewhere between 2.3 to 5.6 grams per deciliter versus their baseline. Very nice improvement in their hemoglobin levels as well. What's coming next for this program? In 2025, we're going to finish the dose escalation phase. We're going to initiate dosing of the expansion phase. That is, we're going to choose two doses, maybe one or two, and then go into an expansion phase. We're going to discuss with FDA what the registrational path is. We're going to present this data and discuss the registrational path in a medical meeting sometime later this year.
So it's pretty exciting to have a drug like this with a major area that's large, that has tremendous medical need, and may offer a completely new approach to treating this indication. The early data seems really exciting to us and to clinicians involved. Let me move to olutasidenib, and I'll rush through this a little bit to give some time for questions. Our IDH1 inhibitor. So what we're doing here in glioma is that you may know glioma is an area that is incredibly challenging, an area where there has not been until recent much improvement in this area. Patients with glioma suffer greatly. And one thing you may not know is that IDH mutations are common in grade two and three glioma, about 70%.
This past year, last year and a half, IDH has been more and more appreciated as a potential approach to treating these patients with IDH mutations. Vorasidenib, a molecule from Servier, originated from Agios, was approved in grade 1 through grade 2 low-grade gliomas, which underscores that there's potential for IDH inhibitors here. Our molecule olutasidenib was part of a phase 2, 1-2 trial that our colleagues at Forma did. About 26 patients in this study, and there's the publication in Neuro-Oncology, and what it shows in highly treatment refractory patients, really patients that have failed everything and still had disease. We had two patients that achieved partial responses, both in enhancing tumors, which are harder to treat, and 10 of these patients achieved stable disease, which in this category, and given that patient population, is a really good result, and we were delighted with that.
We've put in place last year a collaboration with the CONNECT organization. They are doing a TarGeT-D study, which will investigate Oluda as part of that umbrella study in maintenance therapy for high-grade gliomas. This is a study we put in place. They're getting up and running. In a matter of weeks, the CONNECT study will launch, and we should have data sometime in the future. But we're delighted to have that collaboration in place and delighted to have them work in the maintenance facet of this. Ourselves, we'd like to announce that we're going to start a phase two clinical study in this year in recurrent glioma. And we'll come back to you with more details about that study in the near future. But we're excited about the opportunity.
It's a major opportunity in an area with, again, significant unmet need when we have a molecule, this IDH inhibitor, that has been shown to be beneficial, and the whole class of IDH has been shown to be an area where there's opportunity to really contribute substantially to the treatment of gliomas, and I can't tell you how exciting it would be to say we have a drug that treats brain cancer after so much disappointment and lack of therapies available for these patients, so we're super excited about this, as are our colleagues at the CONNECT organization. As I mentioned, the lower bullet point, it's a phase two study in patients that are newly diagnosed that we'll treat them with Oluda and TMZ, a commonly used agent in this area, for a year, and then switch to Oluda monotherapy for the second year.
It's a study we're sponsoring, and we're delighted to do so. We're looking forward to this initiation of enrollment and then data generation in addition to our own study. Let me move on to a strategic alliance we put together with MD Anderson. You may know MD Anderson is one of the premier cancer centers in the world. They pride themselves, and rightly so, are creating the new standard of care in various cancers. And we talked to them about Oluda. They were delighted with the data we shared with them. They shared with us the belief that this could be an excellent contributor to the treatment of various cancers, blood cancers. And we and they are going to work closely together to explore this.
So we put in place a collaboration that will be a four clinical trial collaboration, first in AML, where we're looking initially in relapsed refractory AML patients and then newly diagnosed patients. And that segment's important because it'll generate important data in newly diagnosed AML. That trial, that checkmark means it's activated. In the short time, we'll activate another trial in higher risk MDS as well as MPN. And we've already activated a monotherapy trial looking at CCUS, which is a precursor to lower risk MDS, and lower risk MDS. And in addition, we've activated a trial in post-transplant maintenance for IDH mutated malignancies. So four trials, three of them already activated in key areas to generate important data for Oluda in areas related to AML and surrounding areas. So we're excited about this collaboration.
We're excited that it's going to generate data for us to share with you in the upcoming years. MD Anderson is excited about this themselves. They have a large patient population, so they can enroll some of this nicely for us and help us present the information here. So delighted by this and delighted that now we have activations going on. Let me just touch for a minute on our RIPK1 inhibitor. RIPK1 is also an immune target. We had this program at Rigel. We had discovered a number of molecules, including R552. We partnered this program broadly with Lilly. There's two facets to it. One is the immune disease, where the lead molecule R552, now called ocaducertinib, is in phase 2A study in rheumatoid arthritis. So they're enrolling this study, and we will in the near future have interim data on this trial.
The second part is a CNS disease where they're looking at RIP inhibitors that cross the BBB. We've given them a basket of these inhibitors that do so. And Lilly is now working on selecting which one they want to move into the clinic. And then we'll conduct preclinical work to allow that to happen. It's an area with tremendous opportunity for TNF signaling blockade. But in addition, really pro-inflammatory necroptosis is the one area where this one really highlights the benefit of RIP kinase inhibition. And Lilly has a strong interest in rheumatoid arthritis and other areas of immunology and obviously in CNS diseases. So really an ideal partner for us to work with in moving this program forward across both of those different areas. Let me go to financials. This is a slide I'm very proud of.
It shows you here our quarterly results for each of the total of the products. As you see, coming out of COVID, we were selling about $16 million of Tavalis sales. That's in the orange bars. This past quarter, we reported $31 million, almost a doubling of those sales. And that's a very nice and steady growth for Tavalis. And we look for that to continue. In addition, we licensed Rezlidhia, got it approved, got it launched. And you see in launch phase, it was there. And then now it's beginning to make some meaningful contributions: $4.9 million, $5.2 million, $5.5 million, $7.4 million in product sales for Rezlidhia, a nice contribution. And then the acquisition of Gavreto has already, as I mentioned earlier, $7.1 million last quarter, $8.1 million this quarter. So the sales are increasing nicely, in part driven by continued performance from Tavalis, but then meaningful contributions from these two in-license acquired products.
They are now about a third of our business and probably will continue to grow in that percentage. As I mentioned, our cash position improved by about $20 million in the calendar year 2024 from the start to the end there. And for the first time, we've given guidance. And I think this is important because we're confident in where this business is going. What we guided towards is total revenue of $200 million-$210 million. And that's comprised of net product sales of $185 million-$192 million. Remind you, 2024 product sales were $145 million. So that's a $40 million increase in product sales in this upcoming calendar year. And we're comfortable we can achieve that given what we know about these products and their stage in launch and stage in being part of Rigel's portfolio. It's about a 30% increase at the midpoint there. And I think that's good guidance.
It's good growth in these products. We're also projecting contract revenues outside. This is from our partners outside of the U.S. who sell Tavalis in Europe and Asia primarily, of $15-$18 million. So in addition to that, financial discipline, we anticipate being net income positive for the calendar year 2025. We haven't said to what degree because we want to use these funds to fund existing clinical programs and the new clinical programs I discussed with you today. So we're able to take those exciting opportunities with 289 and lower risk MDS, Oluda and glioma and other areas, and fully fund them ourselves from our own cash flows. That's an exciting place to be as a company. I think that's a truly transformational result that we've been able to achieve this at this stage of our company and given the environment that we're in.
We're delighted by this and delighted, obviously, to talk more about this and give you updates as the year progresses. What we're doing in 2025 is continue to grow the products, Tavalis, Rezlidhia, and Gavreto, and strong year-over-year growth. Like I said, the midpoint of that guidance is about 30%. We're going to couple that with continued financial discipline, allowing us to fund and advance the development programs we discussed and continue to look at other in-licenses and acquisitions to meaningfully add to our near-term cash flow. With that, I'd like to thank you. I think we have about four minutes for questions.
If anybody in the audience has a question, just raise your hand and we'll have a mic runner get you a microphone. Raul, thank you so much for being here today.
Really impressive everything that you're doing, both on the commercial and clinical side. Maybe just to start with the commercial business, you reported strong Q4 revenue. At a high level, could you just talk us through how you're thinking about Q4 and then 2024 as a whole?
Yeah, so 2024 was a really banner year for us. We achieved growth in all the products. Most every quarter was a record quarter for each of the products, which is fantastic. And cumulative, I think a really stellar year for us. The new products are contributing very nicely, both Gavretto and Rezlidhia. But not to be left behind, Tavalis is growing very nicely as well. And in part, it's due to doctors becoming familiar with the product, using it across different types of patients.
Now that they've used it once, they had success, they're far more likely to use it again and again. And that simply takes some time, to be honest with you. And it's been like six years on the market now, but that's what's required for them to get comfortable using something new. And once they use it, they use it again and again, which presents barriers to entry to other succeeding products.
Awesome. Maybe turning over to R289. So you detailed the data presented for R289, but maybe just at a higher level, what gets you excited about this data and why you think it's promising?
What's exciting about it is that, one, there's really what's available out there is really sorely lacking, and it's just very limited in terms of what it provides to the patient population. Patient population is sizable in terms of the numbers of patients.
Yet there's not been a lot of progress. I mean, one approval this past year, but not a lot of progress over the years. So still a substantial need that you can come in with a very different mechanism than it's available now. And that's really what excites us at Rigel. We're coming in with a drug that is different, addressing something fundamental about the disease that had never been addressed before. And that makes us excited. So we think there's a really good chance that we'll contribute meaningfully. Now, very early data in that dose escalation phase I shared with you, not that many patients yet, but boy, that is compelling. Given the nature of those patients, highly refractory, highly treatment experience, failed us about everything, and yet we're showing about a 40% response rate in that stage. That's a very impressive early number.
If we can continue that as we enroll more and more patients and maybe at higher dose groups, that'll be really exciting because I think we'll increase the confidence that this is a real drug. There's nothing that we want to do more at this company than develop that drug as fast as we can. That is our first objective as a company, to move that product forward as fast as possible. The opportunity is tremendous and the medical need is incredibly great. We have the means to do it. We shouldn't be ashamed of, like, well, we just can't afford to do it. That's not the case today. That's a great place to be as a company.
Definitely.
And we're almost at time, but maybe just one quick follow-up to that point is it's really exciting to see you get the fast track designation in lower risk MDS and the orphan drug designation for MDS. Maybe just could you talk about how important those are to development of this program?
They're important in a couple of different ways because they allow us to interact with the agency on a regular basis and more frequently and more fully. And so what they're signaling to us is that they view this opportunity as an important one. And we want to interact with you, Rigel, on a regular basis to get you to move this forward as fast as possible. We want to be your partner and certainly not someone that stands in the way of it.
I think that's a great signal from FDA to give us both of those in a close sequence. And I think it's delightful because it tells us that we have a partner at FDA. And we're going to need that as we move this program forward. I'd like to take a minute to thank each of you for coming on Thursday morning. I appreciate that. And thank you and thank our colleagues at J.P. Morgan for having invited and continuing to hold this conference.
Of course. Thank you so much, Raul. Thank you.