Q2 2025 Rigel Pharmaceuticals Inc Earnings Call

Operator: Greetings and welcome to Rigel Pharmaceuticals' financial conference call for the second quarter, 2025. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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.

Greetings and welcome to ride gel Pharmaceuticals Financial conference. Call for the second quarter, 2025

At this time, all participants are in a listen-only mode.

A brief question and answer session, we'll follow the formal presentation.

As a reminder, this conference is being recorded.

It is now my pleasure to introduce our first Speaker. Ray Fury riel's Executive Vice President general counsel and corporate secretary. Thank you, Mr. Fury. You may begin.

Ray Furey: Welcome to our second quarter 2025 financial results and business update conference call. The financial press release for the second quarter 2025 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 forecast. The description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31st, 2024, and subsequent filings with the SEC, including our Q2 quarterly report on single 10-Q on file with the SEC.

Welcome to our second quarter, 2025 Financial results and business update conference call the financial press release for the second quarter. 2025 was issued a short while ago and can be viewed along with a slides for this presentation, in the news and events section of our investor relations site on rival.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 31, 2024.

Ray Furey: 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.

And subsequent findings with the SEC, including our Q2 quarterly report, and full 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.

Raul Rodriguez: Thank you, Ray, and thank you, everyone, for joining us 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. Beginning on slide four, I will provide an overview of Rigel's accomplishments across the business and our financial results for the second quarter of 2025. Let me start by saying that this was a really great quarter for Rigel. We continue to make significant progress on the execution of our corporate strategy. For those not familiar with Rigel, our focus is on growing our hematology and oncology business through commercial execution, advancing our pipeline, product in licensing and acquisition, and financial discipline. With this in mind, in the second quarter, we achieved net product sales of more than 58 million, an increase of 76% year over year, and our best quarter ever.

At this time, I'd like to turn the call over to President and Chief Executive Officer Raul Rodriguez.

Thank you, Rich. And thank you everyone for joining us today. Also with me today, are Dave Santos, our chief commercial officer

Lisa Royer our chief medical officer and the insurer know our Chief Financial Officer.

Beginning on slide 4, I will provide an overview of Roger's accomplishments across the business and our financial results for the second quarter of 2025.

Let me start by saying that this was a really great quarter for Rachel.

We continue to make significant progress on the execution of our corporate strategy.

For those not familiar with Riel our focus is on growing, our hematology and oncology business. Through commercial execution, advancing our pipeline product, in licensing, and acquisition and financial discipline.

Raul Rodriguez: This all-time high was driven by our growing commercial portfolio and increased sales across all our commercial products. Dave will provide a more detailed update on our three products and their second quarter contributions later on in the call. Total revenue for the second quarter was 101.7 million, including 42.7 million in contract revenues from collaborations. As I discussed during our main call, we notified Lilly that we would not exercise our right to share in future development expenses for OKA-DuSertiv, Rigel's RIPK1 inhibitor, previously known as R552. As a result, we recognized 40 million in non-cash revenue in the second quarter. Dean will discuss the accounting of this in his remarks. Now let's talk about our development opportunities. We are excited about the potential of our development pipeline and our ability to fund the clinical development of R289 and oluracitinib.

With this in mind, in the second quarter, we achieved net product sales of more than $58 million, an increase of 76% year-over-year, and our best quarter ever.

This all-time high was driven by our growing commercial portfolio and increased sales across all our commercial products. They will provide a more detailed update on our 3 products and their second quarter contributions later on in the call total revenue for the second quarter was 101.7 million.

Including $42.7 million in contracts, revenues from collaborations.

as I discussed during our main call, we notified Lily that we would not exercise our right to share in future development expenses for okad do

Riel's ripk1 inhibitor previously known as our 5552.

As a result, we recognized $40 million in non-cash revenue in the second quarter. Dean will discuss the accounting of this in his remarks.

Now, let's talk about our development opportunities.

Raul Rodriguez: R289, our novel and selective dual IRAD-1 and 4 inhibitor, is currently being evaluated in a phase 1B clinical study in patients with relapsed or refractory lower-risk MDS. We completed enrollment in the dose escalation part of this study in July and expect to share updated data from the study later on this year. Lisa will walk us through the latest updates on our development pipeline. While we're focused on our internal development, we're also excited about the potential of OKA-DuSertiv, a potent oral and selective inhibitor of RIPK1, and Lilly's efforts to advance this molecule. In parallel with growing our commercial business and expanding our development pipeline, we remain committed to pursuing additional in-licensing deals or acquisitions of assets that fit our capabilities commercially and our product focus, such as we've already done successfully with both Resilidia and Gavreta.

We are excited about the potential of our development Pipeline and our ability to fund the clinical development of our 289 and older acid in them.

Our 289, our novel and selective dual IRAK1 and IRAK4 inhibitor, is currently being evaluated in a Phase 1B clinical study in patients with relapsed or refractory lower-risk MDS.

We completed enrollment in the dose escalation part of the study in July and expect to share updated data from the study later on this year.

Lisa will walk us through the latest updates on our development pipeline.

While we're focused on our internal development. We're also excited about the potential of okay under certum an important oral and selective inhibitor of ripk1, and Lily's efforts to advance this molecule.

Raul Rodriguez: Underscoring this effort is an emphasis on maintaining financial discipline while making the clinical development investments. This has resulted in both top-line and bottom-line growth and allowed us to generate 59.6 million in net income and to increase our cash balance to more than 108 million in the second quarter. Moving on to slide five, you'll see the growth of our net product sales year over year. We have consistently delivered top-line growth, as evidenced by the 32% compound annual growth rate, or CAGR, from 2021 to 2024. Year to date, in 2025, we have generated 102.5 million in net product sales. This is nearly the same net sales that we generated for the full year of 2023, and so a tremendous start to this year.

In parallel with growing our commercial business and expanding our development pipeline, we remain committed to pursuing additional in-licensing deals or acquisitions of assets that fit our commercial capabilities and our product focus, such as we've already done successfully with both Brazil, Lydia, and Gabrio.

underscoring, the separate is an emphasis on maintaining Financial discipline

While making clinical development investments, this has resulted in both topline and bottom line growth, allowing us to generate $59.6 million in net income and increase our cash balance to more than $108 million in the second quarter.

Like 5, you'll see the growth of our net product sales year-over-year. We have consistently delivered Topline growth as evidenced by the 32%, compound annual growth rate or kagar from 2021 to 2024 year to date. In 2025, we have generated 102.5 million in net product sales.

Raul Rodriguez: We are now raising our total revenue guidance in 2025 to between 270 and 280 million from the previous range of 200 and 210 million, which includes net product sales of 210 to 220 million, an increase from the prior range of 185 to 192 million. This new outlook reflects anticipated growth of 45 to 52% compared to 2024, exceeding the roughly 30% growth rate that we delivered over the last few years. Rigel is in a unique position as a self-sustaining company with the added benefit of a promising pipeline of assets. We remain focused on the execution of our corporate strategy and continuing our progress throughout 2025 and beyond. Now, with that, I will turn the call over to Dave to provide more information on our commercial business for you. Dave?

This is nearly the same net sales that we generated for the full year of 2023. And so a tremendous start to this year.

We are now raising our total revenue guidance in 2025 to between $270 million and $280 million, from the previous range of $200 million and $210 million.

Which includes net product sales of 210 to 220 million, an increase from the prior range of 185 to 192 million.

This new outlook, reflects anticipated growth of 45 to 52% compared to 2024 exceeding. The roughly 30% growth rate that we delivered over the last few years.

Riel is a, in a unique position as a self-sustaining company, with the added benefit of a promising pipeline of assets,

We remain focused on the execution of our corporate strategy and continuing our progress throughout 2025 and Beyond.

Dave Santos: Thank you, Raul. On slide seven, you'll see our three commercial products: Tavalise, Gavreta, and Resilidia. Moving to slide eight, we are thrilled to report another excellent quarter from our commercial portfolio, marked by strong year-over-year growth and an all-time high in revenues in the second quarter of 2025. You can see on the slide how our quarterly and annual net product sales have increased since 2021. We have grown each quarter's sales over the previous year, and that growth continues. In the second quarter of 2024, we reported $33.5 million, and now, for the second quarter of 2025, we generated $58.9 million. Our second quarter results reflect accelerated demand through improved patient affordability in 2025, augmented by favorable growth dynamics, which drove a 76% increase year over year.

Now with that, I will turn the call over to Dave to provide more information on our Commercial Business, for you, okay?

Thank you, Raul.

on slide 7, you'll see our 3 commercial products top, Elise getto Andres Lydia

Moving to slide 8. We are thrilled to report another excellent quarter from our commercial portfolio, marked by strong year-over-year growth and an all-time high in revenues in the second quarter of 2025.

You can see on the slide, how our quarterly and annual net product sales have increased since 2021.

We have grown each quarter sales over the previous year, and that growth continues.

In the second quarter of 2024, we reported 33.5 million. And now for the second quarter of 2025, we generated a 58.9 million

Dave Santos: Our commercial team has been dedicated to execution, driving continued momentum for Tavalise, raising awareness for Gavreta after a successful transition into our portfolio, and improving demand for Resilidia. Slide nine shows a summary of our commercial performance by product. First on Tavalise, I'm pleased to report another record quarter in which we generated $40.1 million in net product sales, an increase of 52% compared to the second quarter of 2024. This growth was driven by continued strong new patient demand with another consecutive quarterly record high and increased carryover demand from new patients that started therapy in prior quarters. For Gavreta, we delivered $11.8 million in net product sales in Q2. As a reminder, in the second quarter of 2024, we recorded $1.9 million of revenue as Gavreta just became commercially available from Rigel in late June of 2024.

Our second quarter results, reflect accelerated demand through improved patient affordability in 2025, augmented by favorable gross tonight Dynamics. Which drove a 76% increase year-over-year,

Our commercial team has been dedicated to execution driving continued momentum for top Elise raising awareness for gurtu after a successful transition into our portfolio and improving demand for res. Lydia

Slide 9 shows a summary of our commercial performance byproduct.

First on Talus.

I'm pleased to report another record quarter in which we generated 40.1 million in net product sales and increase of 52% compared to the second quarter of 2024.

This growth was driven by continued strong new patient demand, with another consecutive quarterly record high and increased carryover demand.

From new patients that started therapy and prior quarters.

Or getto, we delivered 11.8 million in net, product sales in Q2 as a reminder. In the second quarter of 2024, we recorded 1.9 million dollars of Revenue. As to give reto just became commercially available from Rael in late, June of 20.

Dave Santos: On a sequential basis, we saw 32% revenue growth versus the first quarter of 2025, as we continued to see an increase in new patients and carryover demand. We are focused on driving awareness of Gavreta and ensuring patients are educated on the latest treatment guidelines that recommend the use of a RET inhibitor in the front-line setting. And lastly, for Resilidia, we reported $7 million in net product sales, an increase of 36% compared to the prior year period, reflecting demand growth. We continue to focus on educating healthcare providers about the potential benefits of Resilidia for patients with relapsed or refractory IDH1 mutant AML. Driving awareness of the efficacy data for Resilidia in the post-venetoclax setting, which we believe is important to physicians, continues to be a key priority for us.

2024.

On a sequential basis. We saw 32% Revenue growth versus the first quarter of 2025 as we continue to see an increase in new patients and carryover demand.

We are focused on driving awareness of GIVE Reto and ensuring patients are educated on the latest treatment guidelines that recommend the use of a RET inhibitor in the frontline setting.

And lastly, for Lydia, we reported $7 million in net product sales, an increase of 36% compared to the prior year period, reflecting demand growth.

We continue to focus on educating Healthcare Providers about the potential benefits of res. Lydia for patients, with relapsed or refractory idh1 mutant AML.

Driving awareness of the efficacy data for as Lydia in the post venetic clock setting, which we believe is important to Physicians.

Dave Santos: We also believe we have compelling data for the earlier use of Resilidia in mutant IDH1 patients who relapse or are refractory to front-line therapy. To that end, at ASCO in June, we presented data for patients who received Resilidia after either one to two lines of therapy or three or more lines of prior therapy. Patients in the one to two prior regimens group showed a higher overall response rate and longer median overall survival than those who had three or more prior lines of therapy, providing a rationale for initiating treatment with Resilidia earlier in the relapsed or refractory treatment paradigm. This supporting data shows why we believe we have significant opportunity to grow Resilidia in relapsed or refractory IDH1 mutant AML.

Continues to be a key priority for us.

Yeah, in Newton, 98, when patients who relapse or are refractory to Frontline therapy.

To that end at asking June we presented data for patients who received breast Lydia after either 1 to 2 lines of therapy or 3 or more lines of prior.

patients in the

prior regimen.

Showed a high.

Longer median, overall, survival than those who had 3 or more prior lines of therapy.

Providing a rationale for initiating treatment with breast, Lydia earlier in the relapsed or refractory treatment paradigm.

Dave Santos: Overall, we're very pleased by our commercial performance in the second quarter, and I would like to express our sincere thanks to the entire team for their outstanding performance in Q2. Moving to slide 10, we continue to work on expanding access to our products in markets outside of the US. Tavalise is commercially available in Japan, in Europe under the brand name TEBLESS, and in Canada and Israel via our partners Keysay, Gryffols, and Medison. In addition, our partners continue to pursue regulatory approvals for Tavalise in new markets. Most recently, in early July, Keysay's licensing partner, JW Pharmaceutical Corporation, launched Tavalise in South Korea. For Resilidia, in 2024, we expanded our relationship with Keysay to include several countries in Asia for all potential indications, and we entered into an exclusive license agreement with Dr. Reddy's for all potential indications throughout Dr. Reddy's territory.

This supporting data shows why? We believe we have significant opportunity to grow res. Lydia in relapsed or refractory idh1 mutant AML.

Overall, we're very pleased with our commercial performance in the second quarter, and I would like to express our sincere thanks to the entire team for their outstanding performance in Q2.

Living to slide 10. We continue to work on expanding access to our products in markets outside of the US.

Talus is commercially available in Japan in Europe, under the brand name telas and in Canada and Israel via Partners Keys a gripples and meta.

In addition, our partners continue to pursue regulatory approvals for tabis and new markets.

Most recently in early July Kay's, licensing, partner JW pharmaceutical Corporation launched tabi in South Korea.

Dave Santos: We are pleased that access to our products is expanding outside the US, and we continue to explore other opportunities for partnerships to bring our products to other markets around the globe. I will now pass the call over to Lisa to provide an update on our development pipeline. Lisa.

For as Lydia, in 2024, we expanded our relationship with K to include several countries in Asia for all potential indications and we entered into an exclusive license agreement with Dr. Reddy's for all potential indications throughout Dr. Reddy's territory.

We are pleased that access to our products is expanding outside. The US, and we continue to explore other opportunities for Partnerships to bring our products to other markets around the globe.

I will now pass a call over to Lisa to provide an update on our development pipeline.

Lisa Rojkjaer: Thanks, Dave. I will now provide an overview of our pipeline progress and plans for the remainder of the year. I'm on slide 12. Our hematology and oncology pipeline strategy is focused on the clinical development of R289, our novel dual IRAD-1 and IRAD-4 inhibitor in lower-risk myelodysplastic syndrome, or MDS, and the expansion of oluracitinib beyond relapsed or refractory IDH1 mutated AML into other cancers with IDH1 mutations, such as recurrent glioma. Beginning with R289, our phase 1B study in patients with relapsed or refractory lower-risk MDS is progressing well, and enrollment in the dose escalation part of the study was completed in July. We plan to share updated dose escalation data later this year.

Lisa.

Thanks, Dave, I will now provide an overview of our pipeline progress and plans for the remainder of the year.

I'm on slide 12.

Our hematology and oncology pipeline strategy is focused on the clinical development of our 289. Our novel Duo Iraq 1 and Iraq 4 inhibitor in lower risk, Milo, dysplastic syndrome or MDS and the expansion of a luta Beyond relapsed or refractory idh1, mutated, AML, and 2. Other cancers with idh1 mutations such as recurrent. Glomma,

Beginning with r 289, our phase 1B study and patients with relapsed or refractory lower risk, MDS is progressing. Well, and enrollment in the dose, escalation part of the study was completed in July.

Lisa Rojkjaer: We remain on track to initiate the dose expansion part of the study in the second half of the year, which will be a randomized comparison of two doses of R289 in order to select the recommended phase two dose for future studies. For oluracitinib, we believe it has potential in several cancers where mutated IDH1 plays a role. Regarding our partners, oluracitinib is being evaluated as maintenance therapy in IDH1 mutation positive glioma by the CONNECT Cancer Consortium and in IDH1 mutation positive AML and low and high-risk MDS by MD Anderson. We remain open to additional opportunities or collaborations to evaluate oluracitinib in IDH1 mutated cancers. Rigel also remains focused on evaluating potential acquisition and in-licensing opportunities that strategically fit our hematology and oncology portfolio and infrastructure. We're focused on evaluating differentiated assets in hematology, oncology, or related areas that are late-stage programs.

We plan to share updated dose, escalation data later this year.

We remain on track to initiate the dose expansion, part of the study in the second half of the year, which will be a randomized comparison of 2 doses of our 289, in order to select the recommended Phase 2 dose for future studies.

For luta, we believe it has potential. In several cancers where mutated idh1 plays a role regarding our partners allergic to cidnet is being evaluated as maintenance therapy and idh1 mutation positively by the Kinect cancer Consortium, and in idh1, mutation positive AML and low and high-risk MDS by MD Anderson,

We remain open to additional opportunities or collaborations to evaluate aluta Sid, in idh1, mutated cancers.

Lisa Rojkjaer: Now we'll spend a few moments on R289, our dual IRAD-1 and IRAD-4 inhibitor. On slide 14, I'd like to spend a few minutes reviewing the value proposition of R289 in lower-risk MDS. There are about 12,000 previously treated lower-risk MDS patients in the US. There's a high unmet need for therapies in this disease area, particularly for transfusion-dependent patients. This regulation of inflammatory signaling is key to the pathogenesis of lower-risk MDS, and IRAD-1 and 4 mediate this process. Blocking both IRAD-1 and 4 may suppress marrow inflammation and leukemic stem and progenitor cell function and restore normal hematopoiesis. R835, the active moiety of R289, blocks Toll-like receptor and IL-1 receptor signaling in vitro and was active in various preclinical models of inflammation. Clinical proof of concept of the anti-inflammatory effect came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo.

Riel also remains focused on evaluating potential acquisition and in-licensing opportunities that strategically fit our hematology and oncology portfolio and infrastructure. We're focused on evaluating differentiated assets in hematology, oncology, or related areas that are late-stage programs.

Now, we'll spend a few moments on our 289 dual inhibitor, 1 and Iraq.

On slide, 14. I'd like to spend a few minutes, reviewing, the value proposition of our 289 and lower risk MDS.

There are about 12,000 previously, treated lower risk MDS, patients in the US. There's a high unmet need for Therapies. In this disease area, particularly for transfusion dependent patients,

this regulation of inflammatory signaling is key to the pathogenesis of lower risk, MDS, and Iraq, 1 and 4 mediate this process.

Your normal haematopoiesis.

Our 835 the active muy of our 289. Blocks toll-like receptor and il1 receptor signaling in vitro and was active in various preclinical models have inflammation.

Lisa Rojkjaer: As a reminder, R289, which is currently being evaluated in the clinic, is the oral prodrug that is rapidly converted to R835 in the gut. R289 has both fast track and orphan drug designations from the FDA, giving the molecule an expedited regulatory pathway, potential priority review, and seven years of market exclusivity upon approval. Both of these designations underscore the agency's interest in this rare disease, the unmet need of the patient population, and the FDA's willingness to collaborate with Rigel in the development of R289. In addition, R289 has thus far demonstrated a promising clinical profile in a phase 1B study. The initial dose escalation data that were presented at last year's ASH annual meeting demonstrated promising preliminary safety and clinical activity in elderly, heavily pretreated patients with relapsed or refractory lower-risk MDS.

Clinical proof of concept of this anti-inflammatory effect came from a healthy volunteer study in which our 835 markedly suppresses LPS-induced Saito release compared to placebo.

As a reminder, our 289, which is currently being evaluated in the clinic is, the oral pro drug that is rapidly converted to our A35 in the gut.

Our 289 has both Fast Track and orphan drug designations from the FDA, giving the molecule, an expedited regulatory. Pathway potential priority review and 7 years of Market exclusivity upon approval.

Both of these, designations underscore the agency's interest. In this rare disease, the unmet need of the patient population and the fda's willingness to collaborate with Riel in the development of our 289.

In addition, our 289 has thus far, demonstrated a promising, clinical profile and a phase 1B study

Lisa Rojkjaer: While I'm here, I wanted to mention that we noted that with the recent data cut, there was a change in status for one patient previously reported with a minor response, that is, a reduction in the number of red cell transfusions by more than 50% compared to baseline. We discovered that this patient had received additional red cell transfusions that were not entered into the database at the time of the initial analysis. Thus, this patient is no longer considered a responder. I'll discuss the study design in a moment. On slide 15, I'd like to update you on several key milestones for the program that we're focused on this year. First, as mentioned, we completed enrollment in the dose escalation part of our ongoing phase 1B study in July.

The initial dose escalation data that were presented at last year's Ash, annual meeting, demonstrated promising, preliminary safety, and clinical activity. An elderly heavily pretreated patients, with relapsed or refractory lower risk MDS.

While I'm here, I wanted to mention that we noted that with a recent data cut, there was a change in status for 1 patient, previously reported with a minor response that is a reduction in the number of Red Cell transfusions by more than 50% compared to Baseline.

We discovered that this patient had received additional Red Cell transfusions that were not entered into the database at the time of the initial analysis. Thus this patient is no longer considered a responder.

I'll discuss the study design in a moment.

On slide, 15. I'd like to update you on several key milestones for the program that we're focused on this year.

Lisa Rojkjaer: We remain on track to initiate the dose expansion phase in the second half of this year, potentially within the third quarter. We recently engaged with the FDA to discuss the dose expansion phase and to seek preliminary input on a potential path to registration. We're aligned with the FDA on the dose expansion part of the study and will provide more details on the registrational path following completion of the phase 1B study and once we've aligned with the agency on the design of our pivotal study. And lastly, we look forward to sharing updated data from the study later in the year. On the next slide, I'll review the study design. This is our multicenter open-label phase 1B study in patients with relapsed refractory lower-risk MDS that are either transfusion-dependent or have symptomatic anemia. Initial data from the study was presented at ASH in late 2024.

first, as mentioned, we completed enrollment in the dose escalation part of our ongoing, phase 1B study in July,

we remain on track to initiate the dose expansion phase in the second half of this year potentially within the third quarter.

We recently engaged with the FDA to discuss the dose expansion phase and to seek preliminary input on a potential path to registration.

we're aligned with the FDA on the dose expansion, part of the study and we'll provide more details on the registrational path following completion of the phase 1B study and once we've aligned with the agency on the design of our P, pivotal study,

And lastly, we look forward to sharing updated data from the study later in the year.

On the next slide, I'll review the study design.

This is our multi.

Center. Open-label, Phase 1B study in patients with relapsed refractory lower-risk MDS, that are either transfusion dependent or have symptomatic anemia.

Lisa Rojkjaer: The study aims to evaluate the safety, PK, and preliminary efficacy of R289 in this patient population, as well as select a dose for future studies. It includes a dose escalation part utilizing a modified 3 plus 3 design evaluating six dose regimens of R289 and a dose expansion phase, which will compare two doses of R289 head-to-head in order to select the recommended phase two dose. Once this occurs, we'll open up a cohort of patients to explore upfront dosing of R289 in patients that are relapsed, refractory to, or ineligible for ESAs. On slide 17, I'd like to talk about the treatment landscape for lower-risk MDS. MDS is a clonal disorder of hematopoietic stem cells leading to dysplasia and ineffective hematopoiesis. The main consequences for patients are anemia and transfusion dependence, which adversely impact quality of life.

Initial data from the study was presented at Ash in late 2024.

The study aims to evaluate the safety PK and preliminary efficacy of our 289 in this patient population as well as selected dose for future studies.

It includes the dose escalation part utilizing a modified 3+3 design, evaluating six dose regimens of our 289, and a dose expansion phase which will compare two doses of our 289 head-to-head in order to select the recommended Phase 2 dose.

Once this occurs, we'll open up a cohort of patients to explore upfront dosing of our 289 and patients that are relapsed refractory to or ineligible for esas.

On slide 17, I'd like to talk about the treatment landscape for lower risk MDS.

MDS is a

Disorder of Hato poetic stem cells leading to dysplasia and ineffective haematopoiesis.

Lisa Rojkjaer: In addition, infections, iron overload from transfusions, and subsequent organ dysfunction all negatively impact the patient. Therapies used in the upfront setting include erythropoiesis stimulating agents, or ESAs, if patients are eligible, or lispatercept. Lispatercept, and more recently imetastat, are also approved for ESA failure transfusion-dependent lower-risk MDS patients. Finally, hypomethylating agents, or HMAs, are also approved. However, the percentage of patients achieving transfusion independence is low. With eight-week transfusion independence rates approaching 40% with lispatercept and imetastat, there's still a need for safe, effective therapies for transfusion-dependent lower-risk MDS patients that are relapsed refractory to or ineligible for ESAs. Now I'll shift focus to our strategic collaborations. As I've mentioned, we have collaborations in place with CONNECT and MD Anderson to evaluate oluracitinib in other cancers harboring IDH1 mutations. I'm now on slide 19.

The main consequences for patients are anemia and transfusion dependence, which adversely impact quality of life.

In addition infections, iron overload from transfusions and subsequent organ dysfunction all negatively impact the patient.

Therapy is used in The Upfront. Setting include aritha, stimulating agents or essays. The patients are eligible or loose powder sets.

This pattern up and more recently, a metal stat are also proved for Esa failure. Transfusion dependent lower risk MDS patients.

Finally, hypomethylating agents are hmas are also approved. However, the percentage of patients achieving transfusion Independence is low.

For transfusion dependent lower risk MDS patients that are relapsed to fractory 2 or an eligible for esas.

Now, I'll shift Focus to our strategic collaborations.

as I've mentioned, we have collaborations in place with connect and MD Anderson to evaluate a lutasin of in other cancers, harboring idh1, mutations,

Lisa Rojkjaer: CONNECT is a global pediatric neuro-oncology consortium that we entered into a collaboration with last year. In CONNECT's TARGET trial, a molecularly guided phase two umbrella clinical trial for high-grade glioma, the Rigel-sponsored arm of the study, called TARGET-D, will evaluate a post-radiotherapy maintenance regimen of oluracitinib in combination with temozolomide, followed by oluracitinib monotherapy in newly diagnosed patients between 12 and 39 years of age with IDH1 mutation positive high-grade glioma. This study is open for enrollment. In addition to this collaboration with CONNECT, we continue to look at other opportunities to expand our studies of IDH1 mutated cancers through our own studies or collaborative partners, including a potential Rigel-led phase two glioma study. We, along with CONNECT, are excited about oluracitinib's potential to provide a much-needed new treatment option to this underserved patient population with significant unmet need.

I'm now on slide 19.

Connect is a global pediatric neuro-oncology Consortium that we entered into a collaboration with last year.

And connects Target trial a molecularly guided Phase 2 umbrella clinical trial for high-grade Goma. The Riel sponsored arm of the study called Target D will evaluate a post radiotherapy maintenance regimen of eutychus in combination with kemmis followed by a lutin of monotherapy and newly diagnosed patients between 12 and 39 years of age with idh1, mutation positive, high-grade glioma.

This study is open for enrollment.

In addition to this collaboration with Connect, we continue to look at other opportunities to expand our studies of IDH1-mutated cancers through our own studies or collaborative partners, including a potential Rigel Phase 2 GLMMA study.

Lisa Rojkjaer: On slide 20, we summarize our strategic alliance with the MD Anderson Cancer Center to advance oluracitinib more broadly into AML, MDS, and beyond. All four studies within this collaboration are open for enrollment, and we look forward to sharing updates in the future. Now I'll pass the call to Dean to discuss our partnered program with Eli Lilly and our financial results for the quarter. Dean?

We along with connect are excited about a luta's potential to provide a much-needed, new treatment option to this underserved patient population with significant unmet needs.

On slide 20. We summarize our strategic alliance with the MD Anderson Cancer Center to advance the loota sydna. More broadly into AML MDS and Beyond.

All 4 studies within this collaboration are open for enrollment and we look forward to sharing updates in the future.

Dean Schorno: Thank you, Lisa. I'm on slide 22. Before I review our financial results for the quarter, I wanted to provide a brief update on our collaboration with Lilly and the related impact to our financial statements during the quarter. The RIPK1 inhibitor programs are progressing well, and we're excited about the program's potential. OKA-DuSertiv, the 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. Enrollment in the phase 2A study is ongoing. The preclinical CNS penetrant RIPK1 inhibitor program is also progressing toward lead candidate nomination. As Raul mentioned, we notified Lilly that we will not exercise our opt-in right related to the development and commercialization of OKA-DuSertiv. As a result, we recognize $40 million in collaboration revenue in the second quarter.

Now, I'll pass the call to Dean to discuss our partnered program was Eli Lilly and our financial results for the quarter. Dean, Thank you Lisa. I might slide 22 before I review our financial results for the quarter. I want to provide a brief update on our collaboration with Lily and the related impact to our financial statements during the quarter.

The RIPK1 inhibitor programs are progressing well, and we're excited about the program's potential. The non-CNS penetrating RIPK1 inhibitor, previously referred to as R55, is currently being studied in an adaptive Phase 2A/2B clinical trial with up to 380 patients with active moderate to severe rheumatoid arthritis. Enrollment in the Phase 2A study is ongoing.

The pre-clinical CNS, pen print ripk1. Inhibitor program is also progressing toward lead candidate nomination.

Dean Schorno: This is non-cash and related to the release of the remaining cost share liability that was on our balance sheet. Note that under the terms of our collaboration agreement, Rigel will continue to be entitled to receive milestone and shared royalty payments of future net sales. Moving on to our financials, I'm on slide number 24. We reported net product sales of $58.9 million for the second quarter, a growth of 76% year over year, including Tavalis' net product sales of $40.1 million, a growth of 52% year over year, Gavreta net product sales of $11.8 million. As a reminder, Gavreta became commercially available from Rigel in late June of 2024, and we reported $1.9 million in revenue for the second quarter of 2024. Lastly, we reported Resilidia net product sales of $7 million, a growth of 36% year over year.

As row mentioned, we notified Lily that we will not exercise our opt-in, right related to the development and commercialization of okad assertive. As a result, we recognize forty million dollars in collaboration Revenue in the second quarter. This is non-cash and related to the release of the remaining cost share liability. That was on our balance sheet.

Note that under the terms of our collaboration agreement, Roger will continue to be entitled to receive milestones and should royalty payments of future. Net sales.

Dean Schorno: Our net product sales were recorded in that of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $20.7 million. We also reported $42.7 million in contract revenues from our collaborations for the second quarter, primarily consisting of the $40 million of non-cash revenue from Lilly, as well as contributions from Gryffol, Keysay, and Medison related to delivery of drug supply and earned royalties, bringing our total revenues for the second quarter to $101.7 million. Moving to slide 25 and down the income statement to costs and expenses, our cost of product sales were approximately $4.5 million for the second quarter of 2025. Total costs and expenses were $40.6 million compared to $36.4 million for the same period of 2024.

Moving on to our financials. I'm on, slide number 24. We reported net product sales of 58.9 million for the second quarter. The growth of 76% year-over-year, including taboo East, net product, sales of 40.1 million. A growth of 52% year-over-year. Deborah on net product sales of 11.8 million as a reminder Gabriella became commercially available from Riel in late June of 2024 and we reported 1.9 million dollars of revenue for the second quarter of 2024. Lastly, we reported res Lydia, net product sales of 7 million dollars, that growth of 36% year-over-year.

Our net product sales were recorded, net of estimate discounts chargebacks, rebates returns, copay assistance, and other allowances of 20.7 million.

We also reported 42.7 million in contract revenues from our collaborations for the second quarter, primarily consisting of the Forty million dollars of non-cash revenue from lily, as well as contributions from Ripples heay and matthisen related to delivery of drug Supply and earn royalties.

Bringing our total revenues for the second quarter to 1 0 1. 8 7.

Moving to slide 25 and down the income statement to cost and expenses. Our cost of product sales was approximately $4.5 million for the second quarter of 2025.

Dean Schorno: The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to oluracitinib and R289, and higher personnel-related costs and stock-based compensation expense. We reported net income of $59.6 million for the second quarter compared to a net loss of $1 million in the same period in 2024. We ended the quarter with cash, cash equivalent to short-term investments of $108.4 million compared to $77.3 million as of the end of 2024. Turning to our financial outlook for 2025, we're raising our total revenue guidance to approximately $270 to $280 million, an increase from our prior range of $200 to $210 million.

Total cost and expenses were $40.6 million compared to $36.4 million.

Is mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to a luta nib and r28 9 at higher Personnel, related cost and stock-based compensation expense. We reported net, income of 59.6 million for the second quarter compared to a net loss of $1 million. In the same period in 2024.

We ended the quarter with cash cash equivalents and short-term Investments of 1 198.4 million compared to 77.3 million as the n as of the end of 2024.

Dean Schorno: This includes updated net product sales expectations of approximately $210 to $220 million, an increase from the prior range of $185 to $192 million, and contract revenues from collaborations of approximately $60 million, an increase from the prior range of $15 to $18 million. The updated total revenues and contract revenues from collaborations expectations are inclusive of the $40 million in non-cash contract revenue related to Rigel's agreement with Lilly. In addition, we continue to anticipate that we will report positive net income for the full year 2025 while funding existing and new clinical development programs. To wrap up my section, we look forward to continued financial discipline for the remainder of 2025 and beyond. With that, I'd like to turn the call back over to Raul.

Turning to our financial outlook for 2025. We're raising our total revenue guidance to approximately 270 to 280 million an increase from our prior range of 200 to 210 million. This includes updated net product sales, expectations or approximately 210 to 220 million and increase in the prior range of 185 to 192 million and contract revenues from collaborations of approximately 60 million dollars, an increase from the prior range of 15 to 18 million dollars. The updated total revenues and contract revenues from collaborations expectations, for inclusive of the 40 million dollars in non-cash contract Revenue related to Rojo's agreement with Lily.

In addition, we continue to anticipate that we will report positive. Net income for the full year 2025 while funding existing and new clinical development programs.

Raul Rodriguez: Thank you, Dean. And moving on to slide 26. To reiterate, we have made significant advancements over the last several years in expanding our hematology and oncology business. We have consistently delivered meaningful top-line growth, enabling us to fund our business and strategic priorities. We have now raised our net product sales expectations for 2025 and now expect to generate 45 to 52% year over year growth, an increase from the roughly 30% growth that we delivered in the prior four years. Moving on to slide 27. For the remainder of the year, we continue to focus on increasing sales of our three commercial products and delivering on our revenue guidance. We are committed to advancing our phase 1B clinical study, evaluating R289 for the treatment of patients with lower-risk MDS.

To wrap up my section, we look forward to continued financial discipline for the remainder of 2025 and beyond. With that, I'd like to turn the call back over to Raul. Thank you, Dean. Moving on to slide 26.

To reiterate. We have made significant advancements over the last several years. In expanding our hematology and oncology business. We have consistently delivered meaningful Topline growth. Enable us enabling us to fund our business and strategic priorities. We have now raised our net product sales expectations for 2025 and now expect to generate 45 to 52% year-over-year growth. Um an increase from the roughly 30% growth that we delivered in the prior 4 years.

Moving on to slide 27 for the remainder of the year, we continue to focus on increasing sales of our 3 commercial products and delivering on our Revenue guidance.

Raul Rodriguez: We plan to share updated data by year end and potentially initiate the dose expansion phase of the study in the third quarter. For oluracitinib, we plan to continue progress to initiate a Rigel-sponsored phase two study in recurrent glioma while supporting our strategic collaborations with the CONNECT organization as well as MD Anderson. We will also continue to look for opportunities to expand our product portfolio for in-license and/or acquisition of synergistic late-stage assets. With our anticipated strong revenue growth and continued financial discipline, Rigel is well positioned for the near term and for the long term. In closing, on slide 28, Rigel has delivered a strong first half of 2025, and we are focused on continuing that momentum throughout the remainder of the year. Our proven strategy has built Rigel into a profitable, growing, and sustainable business.

We are committed to advancing our Phase 1, B clinical study, evaluating our 289 for the treatment of patients with lower risk MDS. We plan to share updated data by year, end and potentially initiate the dose expansion, phase of the study in the third quarter.

For we plan to continue progress. Uh, to initiate a rival sponsored Phase 2 study in recurring glomma while supporting our strategic collaborations with the Kinect organization as well as MD Anderson.

We will also continue to look for opportunities to expand our product portfolio through in licensed Andor acquisition of synergistic late stage assets.

With our anticipated strong revenue growth and continued financial discipline, Rigel is well positioned for the near term and for the long term.

In closing on slide 28.

Rojo has delivered a strong first half of 2025, and we are focused on continuing that momentum throughout the remainder of the year.

Raul Rodriguez: And with that, I'd like to thank you for your interest, and we will now open the call to your questions. Back to you, operator.

Our proven strategy has built fragile into a profitable growing and sustainable business.

Operator: Thank you. And if you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, to ask a question, press star one on your telephone keypad. And your first question comes from Joe Panginus with HC Wainwright. Please state your question.

And with that, I'd like to thank you for your interest and we will now open the call to your questions, back to you, operator.

Thank you. And if you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue.

You may press star 2. If you would like to remove yourself from the queue for participants using speaker equipment and maybe necessary to pick up your handset before pressing the star Keys. Once, again, ask a question press star 1 on your telephone keypad,

and your first question comes from,

Joe Pantginis: Hi, everybody. Thanks for taking the questions. So, it really, I mean, great growth. You're nice blocking and tackling on Gavreta and Resilidia. Excuse me for the pronunciation. I just, I get, with regard to Tavalis, it looks like it saw a very nice inflection, obviously, with regard to the 52% growth. you mentioned, obviously, it's due to new patient demand and increase of carryover. Just curious, can you split up the percentages contribution to this growth here?

Joe, paninis with HC Wayne Wright, police get your questions.

Hi everybody. Thanks for taking the questions. So, um, it really I mean, great growth, your nice blocking and tackling on Rydia, excuse me for the pronunciation. I just uh, I got um with regard to Tavis, it looks like it saw a very nice inflection obviously with regard to the 52% growth, uh, you mentioned obviously, it's due to new patient demand and increase of carryover. Just curious. Um, can you split up the percentages contribution to this growth here?

Raul Rodriguez: Dave, can you comment on that? Thank you, Joe. Thank you for the question.

Dave Santos: Yeah, Joe, great question. And, I will say that, particularly in the first half of the year, we did have more new patient starts than ever before. So our percentage of our growth due to new patient starts was higher. And I think you heard me say in my prepared remarks, that that was accelerated by, improved patient affordability in 2025.

Joe Pantginis: No, that's great. And just curious, like, what level of surprise, if that, you know, and I'm sort of playing devil's advocate, surprise did you have about that growth and the affordability, versus, you know, a potential bear case out there that Tavalis has reached, a level of steady state?

Do you happen on that? Thank you, Joe. Thank you for the question. Yeah, uh, Joe great question. And, uh, I will say that, uh, particularly in the first half of the year, um, we did have more new patients starts than ever before. So, our percentage of our growth due to new patient, starts was higher, and I think you heard me say, in my prepared remarks, uh, that that was accelerated by uh, improved patient affordability in 2025.

Dave Santos: Well, listen, we have been planning, to continue to grow Tavalis. As you know, we've remained focused on new patient growth. And, what did happen this year, as, you know, is the coverage gap, was eliminated in 2025, due to the Inflation Reduction Act. And, we knew that this could potentially, help us this year because, as you know, Part D drugs or or oral drugs, what happened in the past is patients would, enter into that coverage gap, particularly at the beginning of the year, and it would be, difficult for them to access product. And this year, with a $2,000 annual out-of-pocket cap, for for patients and their ability to potentially even smooth those payments out through the year, they have, much easier ability to access a drug, like Tavalis, an oral agent.

No, that's great. And just curious like what level of surprised if that, you know, and I'm, I'm sort of Playing devil's advocate surprised, did you have about that growth and the affordability, uh, versus, you know, a potential bare case out there that thales has reached, um, a level of steady state?

Well, listen, we have been planning, um, uh, to continue to grow topalli. So, you know, we've remained focused on new patient growth. And uh what did happen this year, as you know, is the coverage Gap. Uh was eliminated in 2025 uh due to the inflation reduction Act.

And uh we knew that this could potentially uh helped us this year because as, you know, Part D drugs or or oral drugs. Um, what happened in the past is patients would enter into that coverage Gap, particularly at the beginning of the year and it would be a difficult for them to access product. And this year, uh, with a thousand dollar annual out of cap pocket cap for for patients, and their ability to potentially even smooth those payments out through the year. Uh, they have

Dave Santos: And I think, you know, we were prepared to ensure that patients, that we were, ready, to address this change at the beginning of the year. And so I I will say that, you know, we've always been focused on new patient starts. Is it potentially a little more, benefit from improved affordability than we had anticipated? I'm not sure I would say that, but, I think the team executed extremely well. And, because we have a portfolio of oral therapies, I think, the entire portfolio benefited from improved affordability in 2025. And that also helped us, improve our gross-to-net dynamics.

your ability to access a drug, uh, like top lease an oral agent. And I think, uh, you know, we were prepared to ensure that patients, uh, that we were, uh, ready, uh,

Raul Rodriguez: So really, the confluence of those things. Sorry, the confluence of those things, Joe, and I think, you know, we were well aware of this coming in and and well prepared to it. So it required both of those things to know it's coming, to know what you're going to do about it. And we executed, I'd say, very well in the first half of the year. Many of those patients carry over into subsequent quarters. And, what used to be a, you know, difficult Q1s, in the past, this, IRA has helped that. And needless to say, more patients are getting drugs that perhaps in the past couldn't have gotten them because of the change. So that's a good thing overall.

So really the Confluence of those things.

Joe Pantginis: No, fantastic. Appreciate all the added color and very nice to see.

So, it's a Confluence of those things. Joe, and I think, uh, you know, we were well aware of this coming in and, and well, prepared to it. So it required both of those things to know. It's coming to know what you're going to do about it. And we executed, I'd say very well in the first half of the Year. Many of those patients carry over into subsequent quarters and, um, what used to be a, you know, a difficult q1's, uh, in the past, uh, this uh, IRA has helped that and needless to say, more patients are getting drugs that perhaps in the past couldn't have gotten them because of the change. So, that's a good thing overall.

No, fantastic. Appreciate all the added color and very nice to see.

Operator: Thank you. And your next question comes from Yigal Nichomovitz with Citigroup. Please state your question.

Farzin Haque: Hey, guys. Congrats on a nice progress commercially and on the pipeline. I'm curious about the comment regarding the 32% CAGR, which you noted from 21 to 24, and then the apparent inflection, higher, substantially higher, 45 to 52. Is the statement that this is the expectation sort of for the business on a go-forward basis, not only this year, but, but into '26 and beyond? Is it, are we on a new, sort of trajectory here, or how would how would you frame that inflection point in terms of thinking about the longer-term performance of of the business?

Thank you. And your next question comes from it with Citigroup, please State your question.

Okay guys. Uh, congrats on a nice, uh, progress commercial and on the pipeline. Um, I'm curious about the, the comment regarding the, the 32% kegger, which you, uh, noted from 21 to 24 and then the apparent inflection, uh, higher substantially higher, 45 to 52, is the statement that this is the expectation sort of, for the business on a go forward basis. Not only this year but, uh, but into the 26th and Beyond is it are we on a new, um, sort of trajectory here, or how we, how, how would you frame that inflection point in terms of thinking about?

Raul Rodriguez: Yeah, I can take that, but I'll I'll also ask Dave to comment on that. You know, you know, this has been a fantastic start to the year. and I think things have happened, dynamics. Dave had just explained a few of them that occurred earlier in this year that I think, gave us a boost. but, you know, the underlying business had been growing quite nicely, 32%, year on year, and Tavalis specifically, a strong performer throughout those years, even, though it's been on the market already. So really, a a a a confluence of various things drove this increase in in sales this year. we haven't given guidance, beyond this year, other than to say we continue to expect growth in the business, and we continue to have confidence that the product, provides meaningful value to these patients.

The longer term performance of of the business.

Yeah, I could take that but I'll I'll also ask Dave to comment on that, you know? Um,

This has been a fantastic.

We continue to expect growth in the business, uh and we continue to have confidence that the product.

Raul Rodriguez: And now we can give, make sure that more of them benefit from these products, being that they're rural in particular. And so we're very, very, enthusiastic about what's to come. And I think a good, great first half of the year is our best ever, and we expect the dynamics to not, to not change dramatically going forward.

Provide meaningful value to these patients.

And now we can.

Make sure that more.

Dave Santos: Yeah, Raul, I would just add that we've got a growing business, obviously. we have been laser-focused on ensuring patients have the opportunity to try Tavalis, Resilidia, or Gavreta, depending, on, what the clinician, which type of patient the clinician has. And we do everything possible to make sure we're efficient in that targeting. And, and, I think what you're seeing is our ability to grow revenues, with, with very little incremental costs on a three-product portfolio. And that's exactly what we're executing on, looking at our impactable opportunities, targeting those, and, with laser-like focus and and going out and getting it. So yes, we definitely plan to continue to, grow new patient starts and demand as we move forward.

The benefit from these products being that they're all particular. And so we're very very um uh enthusiastic about what's to come. And I think a good great first half of the year the best ever. And we expect the Dynamics to not uh to not change dramatically going forward.

It's yeah, I would just add that. We've got a growing business. Obviously, uh we have been laser focused on ensuring patients have the opportunity to try tav's friends, Lydia or Deo depending uh on um, what the clinician uh, which type of patient clinician has. And we do everything possible to make sure we're efficient in that targeting. And, and I think what you're seeing is our ability to grow revenues, uh, with, uh, with very little incremental costs,

On a 3 product.

And that's exactly.

Raul Rodriguez: You also note the the leverage in the business. You have a a stable, good quality commercial organization that really has delivered in the past, and now you add additional products to it, and you see the economic benefit of that.

Looking at our impact opportunities targeting those and, uh, with laser like focus and, and going out and getting it. So yes, we definitely plan to continue to, uh, grow new patient starts in demand as we move forward. You also note the The Leverage in the business who have a, a stable good quality commercial organization that really has delivered in the past and now you add additional

Products to it. And you see the economic benefit of that.

Farzin Haque: Okay, thanks. and then I had a few more specific questions on, on glioma and the olurta development. what more can you say with respect to the, the phase two design? how would you do that study? What would be the right comparator arm? And then regarding the, the work you're doing with this CONNECT and the TARGET-D trial, if that looks good, how would what would you do with that data? Is that something you could then, use for a submission in pediatric, or would you need to then pursue another company-sponsored study to, to take that, pediatric, segment to market?

Raul Rodriguez: I'll ask Lisa to comment on on on those two.

Okay, thanks. Um, and then I had a few more specific questions on, uh, on Goma and the aluda development. What more can you say with respect to the, uh, the phase 2 design? How would you do that study? What would be the right comparator arm and then regarding the um, the work to doing with this connect and the target D trial if that looks good, um, how what would you do with that data? Is that something you could then uh, use to First submission in pediatric? Or would you need to then pursue another company sponsored study to uh to take that uh, pediatric segment to Market?

Lisa Rojkjaer: Yeah. Thanks, Raul. And thanks for the question, Yigal. So regarding our plans, for glioma, we will be disclosing more about the the design of the study and recurrent, glioma, probably later this year once we're we're not yet in the the position to do that, but stay tuned. And for the CONNECT study, that's a very good question as well. there, you know, we we still have to discuss a little bit more with CONNECT and potentially with the agency on on a potential for for looking at that to support a filing. We haven't done any of that yet. I don't anticipate that we would be doing an additional study in that, that same space.

That's Lisa to come in on those two. Yeah, thanks, Ro, and thanks for the question. You.

Um, for Gulley, uh, we will be disclosing more about the the design of the study and recurrent. Uh, Glo probably later this year. Once we're, we're not yet in the, The Physician to do that, but stay tuned and for the Kinect study, um, that's a very good question as well. Um, there, you know, we we still have to discuss a little bit more with connect and potentially with the agency on on a potential for for looking at that to support a filing. We have, we haven't done any of that yet. Um, I don't anticipate that we would be doing

Doing an additional study in that, um, that same space.

Operator: Okay, gotcha. Thank you very much.

Raul Rodriguez: Thank you, Gaul.

Okay, gotcha. Thank you very much.

Thank you, go.

Operator: And your next question comes from Farzin Haq with Jeffries. Please state your question.

and your next question comes from Farson Hawk with Jeff, please State your question,

Farzin Haque: Hi. This is Amin on for Farzin. Congrats on the quarter, and thank you for taking our questions. A couple of questions from us. Well, based on what you're seeing so far in 3Q in numbers of bottles shipped and the IRA impact, how does that shape your thinking around the guidance going forward? And are there any anticipated headwinds or tailwinds specifically around Tavalis sales and Gavreta Rampab at this point? And I have a follow-on.

Hi. This is Amin on for fires in uh congrats on the quarter and uh thank you for taking our questions. Uh, a couple of questions from us. Well, based on uh what you're

Seeing so far in 3 Q in numbers of B bottles shipped. And, uh, the IRA impact, how does that shape your thinking around the guidance going forward and, uh, are there any anticipated headwinds or Tailwinds specifically around Tali sales and Gabriella and Bob at this point

Uh, and I have a follow on.

Raul Rodriguez: Thank you, Farzin. My last data comment on that.

Dave Santos: Yeah. So we just grew, if you take the six months that we just completed and you look at the six months prior to that or the back half of 2024, we just grew 20% in revenues. And in our guidance, at the midpoint of our guidance, we're still projecting double-digit growth in our revenues. And at the top end, it's about 15%. So we are expecting growth to continue. And when I when I said that about improved affordability dynamics in the in the first half of the year, as I said in my earlier remarks, you know, the coverage gap was really an issue at the beginning of the year when patients hadn't been on medications and they were restarting the clock. And that was the time the donut hole experience was more.

Thank you for. So my last date to comment on on that. Um, yeah, so we just grew. If you take the 6 months, um, that we just completed and you look at, um, the 6 months prior to that, or the back half of 2024, we just give 20% revenues.

Um, in revenues, and in, in our guidance, at the midpoint of our guidance, we're still projecting double-digit growth in our revenues. And at the top end, it's about 15%. So we are expecting, uh, growth to continue. And when I, when I said that about improved affordability uh, Dynamics in the, in the first half of the year as I said, uh, in my earlier, uh, remarks, um,

Dave Santos: So we do expect that as we move into the second half of the year, there are fewer patients that kind of fall into that. So we're, I don't think the impact of that will be as strong in the second half of the year. I hope that helps.

The doughnut hole experience was more significant, so we do expect that as we move into the second half of the year, there are fewer patients that kind of fall into that. So, I'm not sure the impact of that will be as strong in the second half of the year.

Farzin Haque: Yes, very helpful. And how much impact are you seeing on the gross-to-net for the three drugs with the part D?

I hope that helps.

yes, very helpful and, uh,

How much impact are you seeing on the gross net, uh, for the tree drugs? Uh, with the party?

Joe Pantginis: So we haven't been specific on the gross-to-net. I will say that from a gross-to-net consideration, there's a variety of factors. There's the we made some distribution channel changes that we talked about in the back half of last year. So that that's had an effect and a favorable effect. The mix also impacts gross-to-net, and there's some favorability, as Dave said, with respect to the IRA adjustments. And then on a go-forward basis, the the mix and some of the programs we do will have an impact on gross-to-net. So we haven't been specific on the individual products, but we expect to see some some favorable gross-to-net as we've seen in the last couple of quarters persist.

Yep. So we we haven't been specifically on the the growth to net. I will say that from a, from a gross net consideration. There's a variety of factors. There's the, we we made some distribution Channel changes. We talked about in the back half of last year, so that that's had an effect and a favorable effect, uh, the mix, uh, mix also impacts growth to net and there's some favorability as Dave said, with respect to the the, the IRA adjustments, uh, and then I'll go forward basis. The, the, the mix and some of the programs we do will have an impact on on Gross to net. So, we haven't been specific on the individual products, but we expect to see, uh, some, some favorable growth in that, as we've seen in the last couple of quarters, you know, persist

Farzin Haque: Thank you very much.

Raul Rodriguez: Thank you, Farzin.

Thank you very much.

Operator: Thank you. And a reminder to the audience, to ask a question, press star one on your telephone keypad. To remove yourself from the queue, press star two. Once again, ask a question now, press star one on your telephone keypad. And your next question comes from Kristen Klesko with Kantor Fitzgerald. Please state your question.

Thank you, Parson.

Thank you, and have a reminder to the audience to ask a question press star 1 on your telephone keypad.

To remove yourself from the queue press star 2. Once again, ask a question now press star 1 on your telephone keypad,

Ayan: Hi, this is Ayan on Kristen's line. Thank you for taking our question. I understand that the primary goal in treating lower-risk MDS is to reduce or eliminate transfusion dependence. What have you heard from physicians on the degree of transfusion reduction or independence that is actually considered clinically meaningful in this setting?

And your next question comes from Kristen kluska with cancer, Fitzgerald, please take your questions.

Treating lower risk and DS is to reduce or eliminate transfusion dependents. What have you heard from Physicians on the green on the degree of transgender reduction or Independence? That is actually to consider clinically meaningful in this setting?

Lisa Rojkjaer: Yeah, I could take that. I mean, you know that, as I mentioned in my prepared remarks, the approvals of lispatercept and imetastat were based on a transfusion and an eight-week transfusion independence rate of around 38 to 40 percent for both agents. So there's, you know, around 60% of patients are still not benefiting. So I think that there's still room for improvement in this in this area. And with hypomethylating agents that were approved around 25 years ago, it's really not much better. So lots of room to improve. So I don't know that that the physicians are, I think anything above this is, you know, people would be looking forward to. And also, you know, considering those agents, there are also associated toxicities and a bit of an inconvenience with the route of administration.

Yeah, I could take that. I mean, um,

you know that, as I mentioned in,

I prepared remarks the uh approvals of loose patter and the metals that were based on a um transfusion in the 8 week. Transfusion Independence rate of around 38 to 40% for both agents. So there's you know, around 60% of patients are still not benefiting. So I think that, um, there's still room for improvements in this, in this area. And with, um,

Hypomethylating agents that were approved around 25 years ago. It's really not much better. So lots of room to

to improve so I I don't know.

the, the

Lisa Rojkjaer: So I think, aside from the activity there, there's also room for improvement in administration.

Ayan: Thank you. Understood.

I think anything above this is, is, you know, people would be looking forward to. And also, you know, considering those agents, um, there are also Associated toxicities and um, a bit of an inconvenience with the route of administration. So I think, um, aside from the activity there, there is also room for improvement in in um, Administration.

Thank you, understood.

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. Thank you.

Thank you.

Raul Rodriguez: Well, thank you. I'd like to be I'm grateful for your attendance to this call and your interest in Rigel. I think this first half of the year, we've really delivered well, and I'm extremely proud on what we've been able to accomplish both in the commercial business, the financial position of the company much stronger today and stronger than I believe it's ever been, and really good advancements also in terms of our product portfolio. So for that, I'd like to thank the employees of Rigel and their dedication to what we're trying to accomplish here. This was a substantial step forward this first half of the year, and we look forward to continuing that. Take care.

And there are no further questions at this time, I would like to turn the floor back over to Mr. Rahu Rodriguez for a closing comments. Thank you.

Well, thank you. I'd like to um uh be I'm grateful for your attendance to these this call. And you're interested in Riel, I think, uh, this first half of the year we've really have delivered well, and are extremely proud on what we've been able to accomplish both in the commercial business. The financial position of the company, much stronger today and stronger than in. I believe it's ever been and really good advancements. Also in terms of our product portfolio. So for that I'd like to thank the the employees of rival and their dedication to what we're trying to accomplish here. This was a substantial step forward, this first half of the year. And and we look forward to continuing that

Operator: This concludes today's teleconference. You may disconnect your line at this time. Thank you for your participation.

Take care.

This concludes today's teleconference. You may disconnect your line at this time. Thank you for your participation.