Rigel (NASDAQ:) Pharmaceuticals, Inc. (NASDAQ: RIGL) has released its financial results for the second quarter of 2024, highlighting significant sales growth and the successful commercial launch of GAVRETO, its newly approved therapy for certain types of cancer. The company reported a 40% increase in net product sales, reaching $33.5 million for the quarter. This growth is attributed to strong sales of TAVALISSE and REZLIDHIA, along with the initial revenue from GAVRETO. Rigel also provided updates on its clinical trials and development programs, including the progress of its IRAK1 and 4 inhibitor R289 and the RIPK1 inhibitor programs with partner Lilly.
Key Takeaways
- Rigel Pharmaceuticals announced a 40% increase in net product sales year-over-year, amounting to $33.5 million.
- GAVRETO, a therapy for metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer, was successfully transitioned to commercial availability.
- TAVALISSE and REZLIDHIA sales reached $26.4 million and $5.2 million, respectively, indicating strong market performance.
- Rigel’s clinical trial updates include the IRAK1 and 4 inhibitor R289’s progress in a phase 1b trial for lower-risk MDS.
- The company’s partnership with Lilly on RIPK1 inhibitor programs is advancing, with a phase 2a clinical trial for Ocadusertib in patients with rheumatoid arthritis.
Company Outlook
- Rigel expects to continue its strong growth in net product sales into the third quarter of 2024.
- The company is approaching financial break-even, reflecting its focus on financial discipline and operational efficiency.
Bearish Highlights
- No specific bearish highlights were mentioned in the provided context.
Bullish Highlights
- Record-breaking sales for TAVALISSE and REZLIDHIA, along with the successful commercial launch of GAVRETO, indicate a positive outlook for Rigel’s product portfolio.
Misses
- The transcript summary did not indicate any misses or shortfalls in Rigel’s financial or operational performance.
Q&A Highlights
- Rigel’s management discussed the growth of new patient starts for TAVALISSE and the potential impact of voracitinib’s FDA approval on their study plans for olutasidenib.
- The company emphasized its ability to handle a more complex product portfolio and expressed confidence in the efficacy of IDH inhibitors.
In conclusion, Rigel Pharmaceuticals has demonstrated strong financial performance in the second quarter of 2024, with significant sales growth and promising developments in its clinical trial programs. The company’s management remains optimistic about future progress and is committed to improving the lives of patients through its therapeutic offerings.
Full transcript – Rigel Pharmaceuticals Inc (RIGL) Q2 2024:
Yigal Nochomovitz – Citi:
Kristen Kluska – Cantor:
Joe Pantginis – H.C. Wainwright:
Operator: Greetings and welcome to Rigel Pharmaceutical’s Financial Conference Call for the Second Quarter 2024. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey, Rigel’s Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey. You may begin.
Ray Furey: Welcome to our second quarter 2024 financial results and business update conference call. The financial press release for the second quarter of 2024 was issued a short while ago and can be viewed along with the slides for this presentation in the news and events section of our investor relations site on Rigel.com. As a reminder, during today’s call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report on form 10-K for the year ended December 31st, 2023, and subsequent filings with the SEC including quarter two quarterly report on form 10-Q on file with the SEC. Any forward-looking statements are made only as of today’s date and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I’d like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul.
Raul Rodriguez: Thank you, Ray, and thank you, everyone, for joining today. Also with me today are Dave Santos, our Chief Commercial Officer; Lisa Rojkjaer, our Chief Medical Officer; and Dean Schorno, our Chief Financial Officer. I’ll begin on slide four. I’m thrilled to introduce you to GAVRETO, the latest addition to Rigel’s product portfolio. GAVRETO is an FDA-approved therapy for the treatment of red fusion positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer that we acquired earlier this year. GAVRETO has become commercially available from Rigel on June 27th. Our patient services, field teams, and distributors work diligently to ensure a smooth transition, enabling us to provide current annually prescribed patients and their providers this important treatment option without any interruption. The addition of GAVRETO to our growing commercial portfolio, now made up of three products, supports top-line growth and leverages our existing commercial and medical affairs expertise and capabilities. Moving on to slide five. In the second quarter, we made meaningful progress towards growing the commercial side of our business. We had $33.5 million of net product sales during the quarter, an increase of 40%, over $23.9 million in the second quarter of 2023. The continued record performance of TAVALISSE and REZLIDHIA, coupled with the addition of GAVRETO, reflects our successful efforts to expand our hematology and oncology portfolio. We look to continue to grow our existing portfolio and to expand it with new products in the future. On the development side, our IRAK1 and 4 inhibitor R289 continues to progress in a phase 1b trial in lower-risk MDS, with enrollment of the fourth dose group nearing completion. We remain on track to share preliminary data from this study by the end of this year. Our strategic collaborations with MD Anderson Cancer Center and CONNECT will enable us to explore REZLIDHIA in a broad range of IDH1 mutant cancers in a cost and time-efficient manner. These programs continue to progress, and we’re excited to share with you today that our first trial with MD Anderson, evaluating REZLIDHIA in patients with AML, has opened for enrollment. Lisa will share more details on this shortly. In summary, in the second quarter, we saw record sales of our commercial products, and combined with our cost-effective approach to clinical development, as well as continued financial discipline, we approached net income break-even. This is great progress. Now with that, I’ll turn the call over to Dave to provide a commercial update. Dave?
Dave Santos: Thanks, Raul. I echo Raul’s excitement to be able to bring GAVRETO to cancer patients as our third marketed, targeted therapy in our commercial portfolio. The successful transition to Rigel was an important step, and we’re pleased that we were able to make GAVRETO available earlier than anticipated. On the left side of slide seven, you see how our products have contributed to our growth over the last 18 months, starting at $23.8 million at the beginning of 2023, to now $33.5 million in Q2 of ‘24. TAVALISSE and REZLIDHIA contributed the majority of that growth, reaching a new high of $31.6 million in net product sales in Q2. The early GAVRETO sales of nearly $2 million added incrementally to our strong portfolio growth. The right side of the slide shows how we’ve generated robust portfolio revenue growth over the past three and a half years. We have grown each quarter’s sales over the previous year, and that growth is significantly accelerating. Just a year ago, our total portfolio sales were just under $24 million in Q2, and we are now reporting $33.5 million in net product sales. That’s nearly $10 million in incremental sales, representing 40% growth. We’re on track to deliver a record year of net product sales in 2024, as our portfolio sales continue to expand in the second half. Our commercial team is focused on execution and driving continued momentum for the three products now in our portfolio. Moving to slide 8, I’ll first discuss our performance for TAVALISSE in the second quarter. On slide 9, you’ll see our FDA-approved indication, which is for adult patients with chronic immune thrombocytopenia, or CITP, who had an insufficient response to a previous treatment. Moving to slide 10, I’m pleased to report another record-breaking quarterly performance for TAVALISSE. We generated $26.4 million in net product sales during the second quarter, a 24% increase from the first quarter, and 25% growth over the same period last year. This growth was driven by continued increases in demand. TAVALISSE achieved its seventh consecutive quarterly record high, with 2,672 bottles shipped to patients and clinics in Q2, representing 8% growth versus Q1, and an 18% increase over the same period last year. Slide 11 shows just how our bottles shipped to patients and clinics have grown over the last 18 months, and it is depicted in bottles per day, so you can appreciate the acceleration in Q2. That growth from 38.8 bottles per day by 3 bottles per day to 41.8 represents our largest quarter-to-quarter increase in the last two years. Even more importantly, we saw our daily bottles grow each and every month during Q2. This accelerating growth has been driven by a continuous flow of new patient starts and strong carryover from refills. Overall, we believe this trend bodes very well for the second half of the year. I want to thank the entire team for all their passion and commitment to continue to impact more CITP patients with TAVALISSE. Moving to slide 12, now I’d like to take a few minutes to discuss our strong quarter growing REZLIDHIA sales. On slide 13, you’ll see our FDA-approved indication for REZLIDHIA, which is for adult patients with relapsed or refractory acute myeloid leukemia with the susceptible IDH1 mutation as detected by an FDA-approved test. Moving to slide 14, we shipped 424 bottles of REZLIDHIA to patients and clinics in Q2, representing strong 30% growth versus Q1 of 2024, and again, more than doubling the demand generated in the same period a year ago. Total bottles sold of REZLIDHIA were 23 bottles less than our bottles shipped to patients and clinics as our distribution channel reduced inventory. This resulted in $5.2 million in second quarter net product sales, doubling compared to a year ago. Moving to slide 15, I’m happy to report that since we set out to expand awareness in the community, we have seen a nice uptick in community demand. In fact, in Q2, the community segment represented about a quarter of our overall demand bottles. This clearly demonstrates how this segment can be an important incremental contributor to our overall growth. Since leukemia treaters in the community are comfortable using venetoclax-based regimens in the frontline setting, the REZLIDHIA post-venetoclax data is particularly meaningful to them. Overall, we still have a significant opportunity to increase awareness and adoption of REZLIDHIA across both segments of our business, and we look forward to doing exactly that in the remainder of the year. Moving to slide 16, we are so pleased to have completed the NDA transfer of GAVRETO to our portfolio, and we are now on our journey to impact even more cancer patients with our third approved targeted therapy. On slide 17, I’ll begin by reviewing the FDA-approved indications for GAVRETO, which include the treatment of adult patients with metastatic RET fusion positive non-small cell lung cancer, as well as adult and pediatric patients 12 years of age and older with advanced RET fusion positive thyroid cancer who require systemic therapy and who are radioactive iodide refractory. First, I wanted to provide an update on how well the entire Rigel team executed a comprehensive and well-thought-out transition plan. Slide 18 shows how we were fully ready upon the June 24th NDA transfer to provide both patients and HCPs with all the support needed to help transition patients to Rigel’s distribution network and patient services. In terms of patient services, our RIGEL ONECARE and Copay websites were up and running within two hours of NDA transfer, and we have now successfully transferred patients to our patient assistance program and Copay program. To further support patients and HCPs, our GAVRETO and GAVRETO HCP websites were also up and running within two hours after NDA transfer, and we had updated Rigel-labeled prescribing information, dosing and administration guides, distribution information, and Copay assistance materials ready for the field to use on that day. And lastly, our field teams across commercial and medical were trained and ready to deliver the GAVRETO availability message directly to their customers to support the successful transition of patients. They quickly contacted a prioritized list of key accounts, enabling the identification of additional GAVRETO patients and prescribers. Moving to slide 19. I’m incredibly grateful to the entire cross-functional team that worked so closely together over four months with the Genentech and Blueprint teams to ensure the successful transition. Because of their collective efforts, GAVRETO officially became commercially available from Rigel on June 27th, and we are extremely proud that our first 3PL shipments went out that day. GAVRETO was stocked in our distribution channel on June 28th, ahead of our target date of July 1st. Our goal was to ensure both current patients taking GAVRETO and those newly prescribed continued to have access to GAVRETO without interruption, and the prescribers can feel confident knowing that their patients can continue getting the therapy they need. So far, our teams have more than delivered on that promise, and we applaud them for their exemplary commitment to patients. And finally, moving to slide 20, you’ll see the two sizes of Rigel-labeled bottles that we now have available. GAVRETO is available in bottles of either 60 or 90 capsules, and for reporting purposes, we will report the total number of 60 count equivalent bottles as we move forward, which are the number of 60 count bottles sold, added to one and a half times the number of 90 count bottles sold. And to wrap up, since we exceeded our goal and Rigel-labeled product was available earlier than anticipated, in the very last week of the second quarter, we shipped 228, 60 count equivalent bottles of GAVRETO to initially stock our distribution channel. This, again, was an outstanding result of flawless execution, working with our distribution network to ensure they had completely winded down their existing inventory of product, and were fully ready to order, receive, and ship Rigel-labeled GAVRETO. Because of these early shipments to stock our network in June, we have already recorded $1.9 million in net GAVRETO revenue. Overall, the GAVRETO transition has gone very smoothly, and Rigel-labeled GAVRETO bottles are now being shipped to patients and clinics each day as planned, just a bit ahead of schedule. Again, I want to express our gratitude to the entire Rigel transition team for working together as one to exceed our goal of ensuring both current and newly prescribed patients continue to have access to GAVRETO without interruption. I look forward to updating you next quarter, and I’ll now turn the call over to Lisa to provide an update on our development programs. Lisa?
Lisa Rojkjaer: Thanks Dave. Moving to slide 22, we outline our strategy to continue expanding our hematology and oncology pipeline. First, we’re focused on advancing our IDH1 inhibitor olutasidenib into new clinical indications. We believe olutasidenib has potential in several cancers where mutated IDH1 plays a role, such as additional AML segments, myelodysplastic syndrome, or MDS, and glioma, either as monotherapy or in combination. To further evaluate olutasidenib in these indications, we’ve entered into strategic development collaborations with the MD Anderson Cancer Center and the CONNECT Cancer Consortium. We’re also advancing our R289, our novel IRAK1-4 inhibitor, in patients with lower-risk MDS. Enrollment continues to progress in our phase 1b trial, and we expect to have preliminary data from the first part of this trial later this year. We also remain focused on evaluating potential opportunities to enlicense or acquire products that would be a strategic fit for our portfolio. We’re looking for differentiated products in hematology, oncology, or related areas. Products that are late-stage, possibly with registrational data, soon to have registrational data, or more advanced, and products that can leverage our hematology-oncology infrastructure. As demonstrated with our acquisitions of olutasidenib and pralsetinib, our goal is to continue to find assets that align with our organization, pipeline, and ability to execute. To start off on slide 23, we’re very pleased to have a development collaboration with the MD Anderson Cancer Center, internationally renowned for cancer care and academic research, to advance olutasidenib more broadly into AML, MDS, and beyond. Through this partnership, olutasidenib will be evaluated in combination with other agents in newly diagnosed IDH1-mutated AML patients for the first time, as well as in other myeloid disorders. We also plan to evaluate olutasidenib as a monotherapy in lower-risk MDS and CCUS, a condition associated with an increased risk of developing MDS, and as post-transplant maintenance therapy. That’s four clinical trials on the horizon, with up to $15 million paid over five years. We expect these trials to position us to conduct a subsequent registrational trial or trials. And I’m excited to share that, as Raul mentioned, the first trial under our research collaboration is now open for enrollment. On slide 24, you’ll see that this is a phase 1b open-label trial that will evaluate the safety and efficacy of a triple combination regimen of IV or oral decitabine, venetoclax, and olutasidenib in patients with IDH1-mutated AML. The focus of the phase 1b part will be to find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to AML patients in phase 2. The primary objective in phase 2 is to determine the complete remission rate in newly diagnosed and relapsed refractory patients. As this study will include an oral formulation of decitabine, it has the potential to lead to an all-oral AML combination regimen, which would be an exciting development for patients that are ineligible for intensive chemotherapy. We and MD Anderson are very excited to kick off this trial and look forward to sharing updates as the study progresses. Moving to slide 25, another important development collaboration we have is with the CONNECT Consortium to conduct a phase 2 trial in patients with IDH1-mutated glioma. Gliomas account for around 30% of CNS tumors in children, adolescents, and young adults, with approximately one-third of these being high-grade gliomas, translating to approximately 800 to 1,000 new cases each year in the U.S. High-grade gliomas are a leading cause of cancer-related death in adolescents and young adults. Despite available therapies, the five-year survival of this population is less than 10%. IDH1 mutations are found in up to 36% of high-grade gliomas in adolescents and young adults. Based on results from a phase 1b clinical trial where olutasidenib was evaluated in patients with relapsed or refractory IDH1-mutated glioma, we believe that olutasidenib has potential in this indication, and olutasidenib will be included in CONNECT’s Target D trial, a molecularly-guided phase 2 umbrella clinical trial for high-grade glioma. The goal of this study is to determine whether the combination of olutasidenib and temozolomide, followed by olutasidenib monotherapy, can prolong the progression-free survival of patients diagnosed with an IDH1-mutated high-grade glioma when given after radiotherapy. We anticipate that this trial will be activated in the second half of this year. We, along with CONNECT, are excited about olutasidenib’s potential to provide a much-needed new treatment option to this underserved patient population. Next, I’d like to update you on progress from our own clinical development program in lower-risk MDS with our novel dual IRAK1-4 inhibitor R289. Lower-risk MDS is another area of high unmet need in a primarily elderly patient population facing progressive cytopenias, particularly anemia, resulting in transfusion dependency, an increased risk of infections, and a risk of progression to acute leukemia. Treatment options for these mostly transfusion-dependent patients are limited. In second and later lines of therapy, durable responses are difficult to attain, and toxicity becomes more of an issue. We believe that R289 has the potential to address the unmet needs in this patient population by targeting inflammatory signaling. Dysregulation of the immune and inflammatory signaling pathways is associated with MDS, with chronic stimulation of both the toll-like and IL-1 receptor pathways involving IRAK1 and IRAK4, leading to a pro-inflammatory marrow environment and cytopenias. IRAK1 and 4 activation independent of this pathway may also lead to persistent inhibition of hematopoietic cell differentiation. Co-targeting both IRAK1 and 4 may fully suppress inflammation and restore hematopoiesis in MDS. Clinically, IRAK4 inhibitors in MDS and AML have thus far only shown modest activity supporting this concept. In preclinical and healthy volunteer studies, R835, a dual IRAK1/4 inhibitor, suppressed pro-inflammatory cytokine production. R289 is an oral prodrug that is rapidly converted to R835 in the gut that is now being evaluated in lower-risk MDS. Slide 27 shows the design of our ongoing open-label phase 1b study of R289 in patients with relapsed refractory lower-risk MDS, which has a dose escalation phase with a standard 3 plus 3 design and a dose expansion cohort for confirmatory safety. The primary endpoints for this trial are safety and selection of the recommended dose for expansion, and secondary endpoints include response rates and PK. Based on emerging data from the study, we’ve recently included two additional cohorts with twice-daily dosing regimens for a total now of five dose levels. The study continues to progress well, and enrollment in the fourth dose level of 250 milligrams twice-daily is nearing completion. We anticipate that we will present preliminary data from the first part of this trial later this year. Lastly, on slide 28, our RIPK1 inhibitor programs are progressing well with our partner Lilly. RIPK1 is implicated in a broad range of inflammatory cellular processes and plays a key role in tumor necrosis factor signaling. Ocadusertib, our non-CNS penetrant RIPK1 inhibitor, previously referred to as R552, is currently being studied in an adaptive phase 2a, 2b clinical trial in up to 380 patients with active moderate to severe rheumatoid arthritis. Phase 2a enrollment of approximately 100 patients is advancing well with preliminary analysis of the phase 2a results anticipated within the first half of 2025. Our preclinical CNS penetrant RIPK1 inhibitor program is also progressing toward lead candidate nomination. We’re excited about the progress of our programs and their broad potential in rheumatoid arthritis and other immune and CNS diseases. Now I’ll pass the call to Dean to discuss our financial results for the quarter.
Dean Schorno: Thank you, Lisa. I’m on slide number 30. During the second quarter, we shipped 2,722 bottles of TAVALISSE to our specialty distributors. 2,672 bottles of TAVALISSE were shipped to patients and clinics, while 50 bottles increased the levels remaining in our distribution channels at the end of the quarter. During the second quarter, we shipped 401 bottles of REZLIDHIA to our specialty distributors. 424 bottles of REZLIDHIA were shipped to patients and clinics, while 23 bottles decreased the levels remaining in our distribution channels at the end of the quarter. In the last week of the second quarter, we shipped 220 bottles of GAVRETO to our specialty distributors. As Dave mentioned, GAVRETO is available in 60-count and 90-count bottles. For reporting purposes, we’ll report the number of 60-count equivalent bottles. We reported net product sales from TAVALISSE at $26.4 million in the second quarter, a growth of 24% compared to $21.3 million in the same period in 2023. We reported net product sales of REZLIDHIA of $5.2 million in the second quarter, a growth of 102% compared to $2.6 million in the same period in 2023. And finally, we reported net product sales from GAVRETO of $1.9 million in the second quarter. Our net product sales from TAVALISSE, REZLIDHIA, and GAVRETO were recorded net of estimate discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $15.5 million. For the second quarter of 2024, our growth to net adjustment for TAVALISSE, REZLIDHIA, and GAVRETO was approximately 34%, 23%, and 23% of gross product sales, respectively. Before we move on from net product sales, let me review our expectations for the third quarter. We’re pleased with the strength of our business and expect to see continued strength in our year-over-year net product sales growth rate. For the third quarter, we expect our growth to net adjustment for TAVALISSE, REZLIDHIA, and GAVRETO to be approximately 35%, 23%, and 26% of gross product sales, respectively. On to the next slide. In addition to net product sales, our contract revenues from collaborations were $3.4 million in the second quarter. Contract revenues from collaborations consisted of $2.2 million from Kissei, $1.1 million from Grifols, and $100,000 from Medison. Moving on to cost and expenses, our cost of product sales was approximately $2.8 million for the second quarter of 2024. Total cost and expenses were $36.4 million, compared to $32.2 million in the same period for 2023. The increase in cost and expenses was partly due to higher cost of product sales, driven primarily by higher amortization of intangibles and royalties. Increased personnel-related costs and increased research and development costs due to the progress of our clinical activities, including our R289, IRAP1-4 inhibitor program. We ended the quarter with cash, cash equivalents, and short-term investments of $49.1 million. We look to maintain our focused and disciplined financial approach into the future. With that, I’d like to turn the call back over to Raul. Raul?
Raul Rodriguez: Thank you, Dean. To conclude, this was a very good quarter for Rigel. We’ve made significant progress across all areas of our hematology-oncology business, including commercial product sales and portfolio, our development pipeline, and our financial position. For each of these areas, I will summarize the quarter and share our outlook. First, we are delighted with the growth of our commercial business. We achieved record sales for both TAVALISSE and REZLIDHIA, and we added a third product GAVRETO to our commercial portfolio. As we look into the second half of 2024, we are focused on continuing this sales momentum, positioning us for meaningful growth on the top line. We will also continue to evaluate additional in-licensing deals and acquisition, as we did with REZLIDHIA and GAVRETO, both great acquisitions to Rigel’s product portfolio that utilize our sales and medical affairs organizations and expertise. Our development pipeline continues to progress with R289 and lower-risk MDS. We expect to generate preliminary data for our phase 1b trial by the end of the year. We are also tremendously excited about that we have opened our, for enrollment, the first trial with our strategic collaborator MD Anderson Cancer Center. To generate additional data on olutasidenib in patients with AML. We look forward to activating additional olutasidenib clinical trials with our strategic collaborators, and to evaluate other opportunities for expanding the development of all our products. Finally, financial discipline remains key to our corporate strategy. As our top line grows, we are approaching financial break-even. This enables us to reinvest in our business, advance current and new pipeline programs, and pursue opportunities to expand our portfolio. With that, I thank you for your interest in our progress in the second quarter, and we will now open the call to your questions. Operator?
Operator: Thank you. [Operator Instructions] Our first question comes from Yigal Nochomovitz with Citi. Please state your question.
Yigal Nochomovitz: Hi, great. Thank you for taking the question. I just had a few. On the IRAK1/4 dose escalation, you mentioned that you added dose levels four and five, twice daily dosing, and there was some emerging data that led to those new cohorts. Could you expand a bit on the reasons for those new cohorts?
Raul Rodriguez: Go ahead, Lisa.
Lisa Rojkjaer: Thanks for the question. As you know, the focus for this study is really to be able to determine the optimal dose for phase 2 expansion, and it’s based, we’re evaluating safety, PK, preliminary efficacy, and we want to be sure that we thoroughly explore all potential combinations or options in terms of once daily and twice daily dosing. So you’ll be hopefully seeing the data at the end of the year.
Yigal Nochomovitz: Okay, thanks. And then for the MD Anderson collaboration, I noticed that several years ago, actually, also through MD Anderson, there was an investigator-sponsored study. It was featured at ASCO with ibuprofen, venetoclax, and azacitidine, which showed around a 67% response rate. Just curious just broadly speaking with this study, what is the goal in terms of what you want to see to be competitive with this triple combination both in the newly diagnosed and relapsed refractory once you get that far?
Lisa Rojkjaer: Yeah, again, thanks for the question. Well, as you know, olutasidenib and ivosidenib are different combinations. Olutasidenib is also a selective IDH1 inhibitor that has a different size and potentially different binding properties than ivosidenib, and so we’re evaluating it in its own right. I mean, we’re encouraged by the preliminary data that have been presented before, but we also have seen potentially higher efficacy in some of the patient populations in our HEIM-101 study, so we’d like to continue to evaluate olutasidenib also in this setting and also particularly potentially with an oral decitabine regimen. As I mentioned, that could lead to a novel oral triplet therapy, which would be really nice for something, nice to have for particularly these elderly patients that are not eligible for intensive therapies.
Yigal Nochomovitz: Okay, thanks. And then just one more on the commercial picture. I’m just curious, Dean and Raul, are you planning, now that you have a fairly established commercial portfolio, is there a point where you’d be– and you’re getting to break even, which is great, is there a point where you would start to feel comfortable with providing some sort of revenue guidance for the company in the coming years?
Raul Rodriguez: Thanks for the question. The business is solidifying, and a couple new additions to the business, REZLIDHIA and GAVRETO really contributed tremendously. Again, new product launches, so it’s a little more difficult to forecast those, but I think giving guidance is something we evaluate on a regular basis, and we’ll continue to do so. And in the future, I certainly see us doing it. I can’t be specific on terms of the timing, though.
Yigal Nochomovitz: Okay, thank you.
Raul Rodriguez: No, one thing you mentioned there that I think is important to highlight is that, really we’re at a point where we’re reaching financial break-even, that is net income break-even or close to it. That’s a really great achievement for the business. It allows us to, in the future, generate cash, and that cash we hope to deploy to generating additional clinical trials for Aluda [ph] and R289, in particular, where we see great opportunities, and we’d like to share that with you in our investor base in the future, but not that distant a future.
Yigal Nochomovitz: Thanks, Raul.
Operator: Thank you. And our next question comes from Kristen Kluska with Cantor. Please state your question.
Kristen Kluska: Hi, good afternoon. Congrats on a great quarter here. So, for TAVALISSE quarter over quarter, you continue to attribute some of the growth to new patient starts. Can you give us a sense of what the key drivers for these new patient starts? Are they patients that aren’t responding to other treatments? Is it physicians are treating some patients with TAVALISSE, getting comfortable prescribing others? And are you seeing earlier line usage in that mix as well?
Raul Rodriguez: Dave, would you tackle that?
Dave Santos: Sure. Kristen, thanks for the question. As we talked about last quarter, I didn’t give you the numbers, but clearly I showed that our new patient starts were increasing, and on a quarterly basis, if you look at the slides from last quarter. That is what we’re focused on. We are focused on growing both our breadth of prescribers, in other words, folks who still, after all these years, haven’t tried TAVALISSE yet, yet they see ITP patients, and then secondly, our depth within prescribers. I think if you look at our business, we’re getting both. New prescribers still make up a pretty significant number of our new patient starts. And in terms of line of therapy, the second part of your question, I shared that a couple quarters ago about how we, in IRAK data were getting more earlier line patients. We continue to look at that. It’s a subset of patients that are out there, but it continues to look very good for earlier line patients. I think what you’re seeing is both of these things. New patients keep coming in. Their carryover keeps coming in month after month, quarter after quarter, and our sales keep growing. That’s what we’re going to continue doing. I can tell you, I’ve now been here for four years. This is something we’ve been focused on, especially during the last couple of years. I think that’s when you’ve seen our growth, particularly post the COVID timeframe.
Kristen Kluska: Okay. Thanks for that. You’ve clearly built a sales force that can work on all three drugs, but how should we think about how you’re going to balance financial discipline with potential new indications or strategies? Should we expect more deals similar to what you did with Forma and Blueprint that are more sparing to the balance sheet initially and gives you time to really generate the sales there? Thanks again.
Raul Rodriguez: Thank you, Kristen. I appreciate the question. These two products have really contributed tremendously to our portfolio, and their effect is that they provide incremental sales, but importantly, because they leverage the current existing organization, a good deal of the sales post cost of goods does drop down to the bottom line once the product is in our portfolio and fully launched. That’s a tremendous value in terms of the financial impact they have. We look to continue to do additional deals going forward. I can’t give you specific timeframes for a deal, other than to say it will be in HEMOC. That’s what we’re focused on. It’ll be a product that leverages our current capabilities, and it’ll be a product that will be near term onto the market because that’s where we get the most value, a lot like these two products. I think we are constantly evaluating out there what is available and where we can use our capabilities to add value to products that we may bring in later. I think they provide tremendous growth opportunity. Incremental to that will be in the longer, longer term as we do additional trials in other areas. We hope to have the same organization sell R289 or other indications for REZLIDHIA in AML, MDS, and other areas.
Dave Santos: Raul, I just might add that through this time we’ve also focused efforts both in the community and institutional segments. So we’ve got different teams out there. But I just want to point out because I think your questions are really good one, Kristen. Twenty months ago, we had one product. For the last year and a half, we’ve had two, and we’ve really learned a lot about managing a couple of different products in the portfolio. I think we put all of that to great use in these last four months. I mean, over four months, they just learned about this less than five months ago. Here we are booking sales in June what we think is a very strong transition with our third product. I think our team– what I want to really talk about here is just our team’s ability to execute on different priorities has really, really matured and solidified over time. That’s why we have confidence that we can bring in even a more complex product portfolio that our team will execute on.
Kristen Kluska: Thanks so much.
Operator: [Operator Instructions] Our next question comes from Farzin Haque with Jefferies. Please state your question.
Raul Rodriguez: There’s a storm on the East Coast.
Operator: We’ll move on to the next question. And our next question comes from Joe Pantginis with H.C. Wainwright. Please state your question.
Joe Pantginis: Everybody, good afternoon. Thanks for taking the question. And, yeah, it’s coming down real hard right now. So some breaking news that I want to ask about and the impact on olutasidenib. So before the market closed today, the FDA approved voracitinib for glioma. So I wanted to ask with regard to potential impact on your study plans as well as potential differentiation.
Raul Rodriguez: Sure, I’ll ask Lisa and maybe Dave to comment on that question.
Lisa Rojkjaer: Yeah, thanks for the question, Joe. So, yeah, so voracitinib, as you mentioned, got approved in patients with grade 2 glioma as in patients that have only received surgery. As you know, voracitinib, it’s a dual IDH1-2 inhibitor. They’ve positioned it currently very early in treatment. We are already, through our collaboration with CONNECT, we have an ongoing, it’s going to be a global study, positioned in the maintenance setting following radiotherapy. So patients would have received surgery, radiation, and then they’re going to receive temozolomide in combination with olutasidenib for a year and then a second year looking at a PFS primary endpoint. And aside from that, we’re also looking at other potential settings, potentially a bit later in line than the voracitinib. From our perspective, it hasn’t really interfered with our evaluation.
Dave Santos: Yeah, and I would just say, Joe, that voracitinib’s data and voracitinib’s approval are really great for us. I mean, it proves that IDH plays a key role in gliomas, and these are very difficult to treat patients and tumors. This is exactly why the World Health Organization changed to, when you look at grade 3 and grade 4 gliomas, IDH mutations are key to that. And I think this is proof in principle that IDH inhibitors work, and that’s why we’re really excited about to have olutasidenib in our portfolio.
Raul Rodriguez: And needless to say, Joe, I think there’s opportunities beyond the voracitinib approval and label that I think we’re exploring, and there are obviously differences between that molecule and our molecule that I think, as we explore that further, we’ll highlight for you.
Joe Pantginis: Great. Thank you, guys.
Operator: Thank you. And there are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.
Raul Rodriguez: Well, thank you, everyone. In closing, I’d like to thank you for joining us on this call and for your continued interest in Rigel and our progress. And as always, I’d like to thank our employees for their continued commitment to improving the lives of patients, as every single day counts, and every single day, we have to make their lives better as well. So thank you for that, and look forward to updating you on our future progress on other calls. Have a great day, everyone.
Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
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