Q3 2023 Rigel Pharmaceuticals Inc Earnings Call

Speaker 1: Greetings and welcome to Rigel Pharmaceuticals Financial Conference Call for the third quarter of 2023. At this time all participants are...

Greetings and welcome to Rigel Pharmaceuticals Financial conference call for the third quarter of 2023.

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

A brief question and answer session will follow the formal presentation.

Speaker 1: The brief question and answer session will follow the formal presentation.

Speaker 1: If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. As a reminder, this conference is being recorded.

If anyone should they should require operator assistance during the conference. Please press star zero from your telephone keypad.

Minder This conference is being recorded.

Speaker 1: It is now my pleasure to introduce our first speaker, Ray Furey, Nigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey. You may begin.

It's now my pleasure to introduce our first speaker Riflery Rigel as executive Vice President General Counsel and corporate Secretary.

Thank you Mr Ferry you may begin.

Speaker 2: Welcome to our third quarter 2023 financial results business update conference call a financial press release for the third quarter 2023 Was issued a short while ago and can be viewed along with the slides of this presentation In the news and events section of our investor relations site on rijal.com as a reminder

Welcome to our third quarter 2020 financial results business update conference call, our financial press release third quarter 2023.

<unk> issued a short while ago and can be viewed along with the slides of this presentation and the news and events section of our Investor Relations.

Hum.

As a reminder, during today's call.

Speaker 2: we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development.

We may make forward looking statements regarding our financial outlook.

Plans and timing regulatory and product development.

Speaker 2: These statements are subject to risks and uncertainties that may cause actual results to differ from those forecast.

Apus are subject to risks.

Certainties and may cause actual results to differ.

Forecast.

Speaker 2: The description of these risks can be found in our most recent annual report on Form 10K for the year ended December 31, 2022, and subsequent filings with the SEC, including our third quarter quarterly report on Form 10Q on file with the SEC.

A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2022, subsequent filings with the SEC, including our third quarter quarterly report on Form 10-Q filed with the SEC.

Speaker 2: 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.

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.

Speaker 2: At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul. Thank you, Ray, and thank you everyone for joining today. Also with me today are Dave Santos, our Chief Commercial Officer, and Dean Shornam, our Chief Financial Officer.

At this time I would like to turn the call over to our President and Chief Executive Officer Raul Rodriguez.

Thank you Ray and thank you everyone for joining today also with me today are David Santos, our Chief commercial officer, Indeed, shortening our chief Financial Officer.

Speaker 2: Let me begin on slide four. The third quarter was an important one for Rigel, one in which we made meaningful progress on growing the sales of our commercial products.

Let me begin on slide four the third quarter was an important one for Roger one in which we've made meaningful progress growing the sales of our commercial products.

Speaker 2: This growth, coupled with tight financial discipline, allowed us to make important progress on our plans to reach financial break even. We reviewed the components of this during today's presentation.

This growth coupled with tight financial discipline allowed us to make important progress on our plans to reach financial breakeven.

We review the components of this story today's during today's presentation.

Speaker 2: Regarding product sales, in the third quarter, we delivered a robust performance for our first approved product, Tavalise, for adult chronic ITP. Demand bottles shipped to patients in cleaning clinics reached a new quarterly record since launch. We grew net product sales by 15%, quarter over quarter, and 27% year over year.

Regarding product sales in the third quarter, we delivered a robust performance for our first approved product <unk> for adult chronic I G. P.

The man bottles shipped to patients and Cleveland Clinic's reached a new quarterly records since launch.

We grew net product sales by 15% quarter over quarter, and 27% year over year.

Speaker 2: We are pleased with the continued momentum that our team is generating for colonies.

We are pleased with the continued momentum that our team is generating fatalities.

Speaker 2: For our second approved product, Reslydia, for adult relapse or refractory mutant IDH1 positive AML, we saw continued growth in bottles shipped to patients and clinics in the third quarter as we increased awareness of the product through our new institutional sales.

For our second approved product bridges linear for adult relapsed or refractory B I D. H one positive AML. We saw continued growth in bottles shipped to patients and clinics in the third quarter as we increased awareness of the product through our new institutional sales team.

Speaker 2: Just last week, we announced several poster presentations at the ASH meeting, which include new supportive data on Reslydia in various mutant IDH1 relapse or refractory AML patient population.

Just last week, we announced several poster presentations at the Ash meeting, which includes new supportive data and with video and various moving 90, H, one relapsed or refractory AML patient populations.

Speaker 2: We look forward to engaging with the medical community at the ASH meeting to further raise awareness and highlight our product.

We look forward to engaging with the medical community at the Ash meeting to further raise awareness and highlight our products.

Speaker 2: Shifting to our development programs, here we're extremely focused and cost efficient in our effort.

Shifting to our development programs here, we're extremely focused and cost efficient in our efforts.

Speaker 2: With R289, our IRAC1N4 inhibitor in phase 1B for lower risk MDS, we are currently enrolling in the third cohort, and we expect initial results from all dose groups in mid-2024.

With our to ignite our Iraq, one in four inhibitor in phase one be for lower risk Mds. We are currently enrolling the third cohort and.

And we expect initial results from all dose groups in mid 2024.

Speaker 2: We continue to evaluate clinical development options to expand our pipeline, particularly with olecitonin. We believe olecitonin has potential in a variety of settings in AML and in additional cancers where RUTIN-IDH1 plays a role.

We continue to evaluate clinical development options to expand our pipeline, particularly with all the shooting them. We believe always tuned up has potential in a variety of settings in AML and in additional cancers were beaten 90 H one plays a role.

We plan to be modest.

Speaker 2: We plan that modest, focused investments in our He-Monk opportunities will be funded from our own internal business. I will touch on this more later.

The modest focused investments in our hemo opportunities will be funded from our own internal business.

We'll touch on this more later in the presentation.

Speaker 2: In addition, we continue to assess and license opportunities for late-stage hematology oncology products to broaden our pipeline that are synergistic and further leverage our in-house capabilities.

In addition, we continue to assess and license opportunities for late stage hematology oncology products to broaden our pipeline that are synergistic and further leverage our in house capabilities.

Speaker 2: summary, this past quarter was important as we made good progress on our plan to reach financial breakeven. This is based on strong growth from our commercial business and a financial expense discipline.

In summary, this past quarter was important as we made good progress on our plan to reach financial breakeven. This is based on strong growth from our commercial business and a financial expense discipline.

Speaker 2: Now let us review this in more detail, starting with Dave on our commercial business. Dave? NeeP explains why this conversation started right after it was made

Now, let's review this in more detail starting with Dave on our commercial business.

Thank you Raul.

Speaker 3: Now, I'd like to take a few minutes to discuss our continued growth of Tovolese during another sequential record quarter and our progress with the Reslyvia launch in the first nine months of 2020.

Now I'd like to take a few minutes to discuss our continued growth in top lease during another sequential record quarter and our progress with the rents linear launch in the first nine months of 2023.

On slide six you'll see the FDA approved indication for top of lease which is for adult patients with chronic immune thrombocytopenia or <unk>, you've had an insufficient response to a previous treatment.

Speaker 3: On slide six, you'll see the FDA approved indication for tovolese, which is for adult patients with chronic immune thrombocytopenia, or CITP, who had an insufficient response to a previous...

Speaker 3: Moving to slide seven, I'm excited to report that we achieved yet another back-to-back new quarterly all-time high with Tavalise in Q3, shipping 2,412 bottles to patients in clinics, resulting in an impressive 19% growth over Q3 of 2022.

Moving to slide seven I'm excited to report that we achieved yet another back to back new quarterly all time high with probably some Q3 shipping 20, 412 bottles to patients and clinics, resulting in an impressive 19% growth over Q3 of 2022.

Speaker 3: We achieved our fourth consecutive record high for the number of bottles shipped to patients in clinics in a quarter since launch, and our demand is continuing to grow with more new patients starting problems.

We achieved our fourth consecutive record high for the number of bottles shipped to patients and clinics in a quarter since launch and our demand is continuing to grow with more new patients starting top leagues.

Speaker 3: For 2-3, we produced pop-a-least net sales of $24.5 million. $5.3 million above the same quarter last year, representing more than 27% year-over-year growth.

For Q3, we produced probably net sales of $24 5 million $5 $3 million above the same quarter last year, representing more than 27% year over year growth.

Speaker 3: We were very excited to achieve this record high quarter in Tollie's Net Sale.

We were very excited to achieve this record high quarter in <unk> net sales.

Speaker 3: Our achievement of sequential quarterly records demonstrates that our continued focus on bringing more new patients to Tovolese and consistently improving our refill business is driving strong growth.

Our achievement of sequential quarterly records demonstrate that our continued focus on bringing more new patients to <unk> and consistently improving our refill business is driving strong growth.

Speaker 3: We are pleased with how we have expanded our tovalese business during 2023 and look forward to maintaining this momentum as we close out the year.

We are pleased with how we have expanded our tommy's business during 2023 and look forward to maintaining this momentum as we close out the year.

We will stay focused on targeting clinicians to identify appropriate patients who can benefit from probably's to continue growing our new patient starts.

Speaker 3: We will stay focused on targeting clinicians to identify appropriate patients who can benefit from Pavuliz to continue growing our new patient start.

Speaker 3: And slide 8 provides a little more detail on how our new patients start to be trending over the last three years.

And slide eight provides a little more detail on how our new patient starts have been trending over the last three years.

Speaker 3: As you'll recall, in 2020 during the pandemic, we were challenged growing new patient start.

As you'll recall in 2020 during the pandemic, we were challenged growing new patient starts.

Speaker 3: Then, with our Salesforce expansion and the post-COVID reopening in 2021, our new patient starts began to improve as we moved into the second quarter of that year.

Then with our sales force expansion and the post Covid reopening in 'twenty 'twenty. One are new patient starts began to improve as we moved into the second quarter of that year.

Speaker 3: Ever since then, with our focus on reaching more clinicians and spreading awareness of Tavalise's durable efficacy in improving platelet levels over time, we have been growing new patient starts consistently.

Ever since then with our focus on reaching more clinicians and spreading awareness top of leases durable efficacy in improving platelet levels over time, we have been growing new patient starts consistently.

Speaker 3: In fact, since 2020, we have achieved a double digit cager of 12%. And that bodes well for continued brand growth as we move into the final quarter of 2023 and beyond.

In fact since 2020, we have achieved a double digit CAGR of 12% and that bodes well for continued brand brands as we move into the final quarter of 2023 and beyond.

Speaker 3: Overall, I'm very proud of this strong Tauvelese quarter and year-to-date growth trends our team brings.

Overall, I'm very proud of the strong <unk> quarter and year to date growth trends our team produced.

Speaker 3: Moving to slide nine, I'll take a few minutes to discuss our continued progress watching Res Lydia through the first nine months of 2020.

Moving to slide nine I'll take a few minutes to discuss our continued progress watching rents linear through the first nine months of 2023.

Speaker 3: On slide 10, you will see our FDA approved indication for reslamia, which is for adult patients with relapse to refractory acute mildewind leukemia with the susceptible IDH1 mutation as detected by an FDA approved test.

On Slide 10, you will see our F. D. A approved indication for risk linear which is for adult patients with relapsed or refractory acute myeloid leukemia with the susceptible I D. H one mutation as detected by an FDA approved test.

To review on Slide 11, there continues to be an unmet need for applications targeted treatments in relapsed or refractory AML and in particular agents that provide longer durations of response, and an acceptable balance of efficacy and toxicity or need it.

Speaker 3: To review on slide 11, there continues to be an unmet need for application's targeted treatments in relapse through refractory AML. And in particular, agents that provide longer durations of response and an acceptable balance of efficacy in toxicity.

Speaker 3: We continue to strongly believe that Reslydia addresses those needs, and that has been our focus during the ongoing watch.

We continue to strongly believe that was linear addresses those needs and that has been our focus during the ongoing watch me.

Speaker 3: Moving to slide 12 and our view of the currently eligible patient population for risk.

Moving to slide 12, and our view of the currently eligible patient population for Wrestlemania.

Speaker 3: The American Cancer Society estimates that more than 20,000 patients will be diagnosed with AML. And of those patients, our research showed that whether patients are treated with intensive therapy or not, most are refractory or relapse within two years.

The American cancer Society estimates that more than 20000 patients will be diagnosed with AML and that those patients. Our research shows that whether patients are treated with intensive therapy or not most of refractory.

Or relapse within two years.

Speaker 3: With 6 to 9% of patients having the IDH1 mutation, we believe we have a near-term opportunity to impact the lives of around 1,000 new mutant IDH1 patients in the relapse to refractory setting.

With 6% to 9% of patients having the I D. H one mutation. We believe we have a near term opportunity to impact the lives of around 1000, New youth 19 inch when patients in the relapsed refractory setting each year.

Slide 13 shows our continued launch today progress in bringing rents linear to those 1000 patients.

Speaker 3: 513 shows our continued launch today progress in bringing Res Lydia to those 1000 patients.

Speaker 3: We shipped the total of 221 bottles of Reslydia to patients and clinics in the third quarter, representing 18% growth over Q2.

We shipped a total of 221 bottles of rents Lydia to patients and clinics in the third quarter, representing 18% growth over Q2.

Speaker 3: We sold 210 bottles, resulting in $2.7 million in net sale.

We sold 210 bottles, resulting in $2 $7 million in net sales.

Speaker 3: We sold 11 fewer bottles than we shipped to patients in clinics this quarter as our distributors reduced inventory on hand.

We sold 11 fewer bottles than we shipped to patients and clinics this quarter as our distributors reduced inventory on hand.

Speaker 3: Overall, since the product became available in late December of 2022, we have achieved total launch to date net sales of $7.6 million.

Overall since the product became available in late December of 'twenty 'twenty. Two we have achieved total launch to date net sales of $7.6 million.

Speaker 3: We continue to remain focused on growing awareness of Res Lydia through our field teams and other launch exercises.

We continue to remain focused on growing awareness of rents linear through our field teams and other launch activities.

Speaker 3: Moving to slide 14, I want to share our progress on improving new patient starts on Reslydia, particularly within key institutional accounts.

Moving to slide 14, I want to share our progress on improving new patient starts on Wrestlemania, particularly within key institutional accounts.

Speaker 3: Because Buden IDH1 relapster refractory AML is a rare disease, and we are still building awareness of Reslidia in this launch period, new patients start can vary from month to month.

Cuz use 90, H, one relapsed or refractory AML is a rare disease and we are still building awareness of breast linear in its launch period, new patient starts can vary from month to month.

Speaker 3: With that context, I'm pleased to report that during Q3, new patients start surged to our highest level within a single month in September .

With that context I'm pleased to report that during Q3, new patient starts searched to our highest level within a single month in September.

Speaker 3: Importantly, this monthly high was driven by institutional start.

Importantly, this monthly high was driven by institutional starts.

Speaker 3: It was a combination of some key academic institutions starting more patients.

It was a combination of some key academic institutions starting more patients.

Speaker 3: as well as new key institutions starting their first patient on Rislin.

As well as new key institutions, starting their first patient address Lady yet.

Speaker 3: We were very pleased to see both our depths and breath grow across institutional.

We were very pleased to see both our depth and breadth grow across institutional accounts.

Speaker 3: We believe that this improvement in institutional adoption occurred because of TURY.

We believe that this improvement in institutional adoption occurred because of two reasons first as we have discussed our evidence in mute 90, H one relapsed refractory AML continues to strengthen.

Speaker 3: First, as we have discussed, our evidence in mute 981 relapse refractory AML continues to strengthen.

Speaker 3: Efficacy in the post-vanetoclax patient population is an important consideration for clinicians, as this is a particularly difficult population to treat.

Efficacy in the post <unk> patient population is an important consideration for clinicians as this is a particularly difficult population to treat.

Speaker 3: Data that was presented at EHA supports Resolidious Evocacy in that population. And our medical affairs team continues to receive feedback that the eludicative data in that patient population is compelling to AML treaters.

Data that was presented at Aha supports retreads Linnaeus efficacy in that population and our medical affairs team continues to receive feedback that the elitist Sydney data in that patient population is compelling to AML treaters.

Secondly, and importantly, we successfully deployed our institutional team during Q3.

Speaker 3: Secondly and importantly, we successfully deployed our institutional team during Q3. All team members were onboarded and have had a significant impact in improving Rachel's presence and Res Lydia awareness at their key institutions.

All team members were Onboarding and have had a significant impact improving Ryan Jos presence and Reds linear awareness at their key institutions in.

Speaker 3: In a very short time, we have significantly improved our ability to raise Resilient awareness to a broader audience of key leukemia treaters. And as a result, our new patient starts in key institutional counts have improved.

In a very short time, we have significantly improved our ability to raise rents linear awareness to a broader audience of key leukemia treaters and as a result, our new patient starts in key institutional counts have improved.

Speaker 3: In the graph on the right, you will see that nearly 90% of our new business in Q3 was driven by institutional accounts. We believe these votes well for our new business as we move forward in the launch. As the Chemia Treaters in these key institutional accounts, influence and improve awareness of Rizlidia in the community.

In the graph on the right you will see that nearly 90% of our new business. In Q3 was driven by institutional accounts. We believe this bodes well for our new business as we move forward in the watch as leukemia treaters in these key institutional accounts influence and improve awareness of Rensselaer.

Yet in the community.

Speaker 3: Overall, we are very encouraged by the new patient increase in September and believe we are on the right track to grow our Res Lydia business in both the institutional and community segments as we move through this important first year block.

Overall, we are very encouraged by the new patient increase in September and believe we are on the right track to grow our rents lithium business in both the institutional and community segments as we move through this important first year of launch.

Speaker 3: Moving to slide 15, based on our first nine months of 2023, and especially the success we saw in September , new patients.

Moving to slide 15 based on our first nine months of 2023, and especially the success. We saw in September new patient starts we believe that Reds linear has the potential to address many key patient and H C. P needs in refractory AML is a promise.

Speaker 3: We believe that Reslydia has the potential to address many key patient and HCP needs in refractory AML. It is a promising treatment targeting mutant IDH1 that has shown impressive durable responses in patients who have failed previous therapies, including men at a class.

Zinc treatment targeting mute 90, H, one that has shown impressive durable responses in patients who failed previous therapies, including Vanadic lax.

Speaker 3: Overall, we continue to see exciting potential to become a market-leading treatment in mutant IDH1 relapse to refractory AML and are looking forward to continuing to execute our launch.

Overall, we continue to see exciting potential to become a market leading treatment in mute 90, H, one relapsed or refractory AML and are looking forward to continuing to execute our launch plan. My thanks to the team for all their efforts during 2023 with threats linear and I look forward to providing you with additional.

Speaker 3: My thanks to the team for all their efforts during 2023 with Res Lydia, and I look forward to providing you with additional launch updates as we move into this.

Watch updates as we move into the future.

Speaker 3: Finally, on slide 16, just a brief word on ash. Ash is critically important to both Tovelies and Reds Lydia. And this will be the second year. We will be displaying both approved products at this major conference of hematology special.

Finally on slide 16, just a brief word on ash.

Cash is critically important to both <unk> and Reds linear and this will be the second year, we will be displaying both approved products at this major conference of hematology specialists.

Speaker 3: We will have a strong presence in San Diego, both from a promotional and scientific set.

We will have a strong presence in San Diego, both from a promotional and scientific standpoint.

On the scientific side, we will have additional data from the illegal Sydney phase one two trial presented at ash highlighting more keep mute 90, H, one relapsed refractory patients along with the post spin out of class patient population.

Speaker 3: On the scientific side, we will have additional data from the elucidative phase 1-2 trial presented at ash, highlighting more T-mute 90H1 relapse refractory patients, along with the post-finetic clax patient population.

Speaker 3: and will be providing more evidence from populations outside of our province.

And we'll be providing more evidence from populations outside our pivotal cohorts.

Speaker 3: We're looking forward to showcasing Rigel's growing HeMOC portfolio, raising awareness of Rigel, our pipeline, and of course, Tavalise and Resilient.

We're looking forward to showcasing rigel is growing him on portfolio raising awareness of Rachel our pipeline and of course top of lease cameras Lady here.

Speaker 2: Thanks for your attention, and I will now turn the call back over to Raul to provide a brief update on our development progress. Raul? Thank you, Dave. I will now summarize our expansion plans for Ola Sootenen and provide updates on our other development programs.

Thanks for your attention and I will now turn the call back over to Ralph to provide a brief update on our development progress.

Thank you, Dave I will now summarize our expansion plans for all of their students and provide updates on our other development programs.

Speaker 2: Beginning on slide 18, we like the growth of our commercial business, and we want to expand our business even further. There are two ways of accomplishing this. First, there's potential the potential to grow our current products with new supportive data, and particularly with new indications. In addition, there's the potential for enlightenment.

Beginning on slide 18, we liked the growth of our commercial business and we want to expand our business. Even further there are two ways of accomplishing.

First there's a potential a potential to grow our current products with new supportive data and particularly with new indications in.

In addition, there's the potential for in licensing of new products.

Speaker 2: Based on an in-depth review, we believe that olesutinib has potential in numerous cancers where mutant IDH1 plays a role. We see additional segments in AML, glioma, and MDS has promising indications for olesutinib.

Based on an in depth review, we believe that all the suite in Europe has potential in numerous cancers, where mutant I D. H one plays a role.

We see additional segments in AML.

And MTS is promising indications for all of a sudden.

Speaker 2: Post-a-matum also has potential in other he-munk indications. And we will provide additional data through investigator-sponsored trials rather than through our own trials. As we think this is the-

While some of them also has potential in other chemo indications and we will provide additional data through investigator sponsored trials rather than through our own trials.

As we think this is the best use of our resources.

Speaker 2: Any investments in new development opportunities will be focused and cost efficient and can be funded by our own operations. As part of this, we expect to work with academic centers and government partners on these strategic efforts.

Any investments in new development opportunities will be focused and cost efficient and can be funded by our own operations as part of this we expect to work with academic centers and government partners on these strategic efforts.

Speaker 2: Moving on to the right side of this slide. The in-missing of Resolidia was a success, and provided right to with an approved product that is highly synergistic with our human capability.

Moving out to the right side of this slide so you shouldn't think of originally it was a success and provided Roger with an approved product that is highly synergistic with our hemo capabilities.

Speaker 2: We look to replicate this as we continue to evaluate the in-licensing of new assets that are also synergistic with our existing infrastructure.

We look to replicate this as we continue to evaluate the in licensing of new assets that are also synergistic with our existing infrastructure infrastructure.

Speaker 2: We are looking for hemoan and related assets that are in late-stage clinical development in review for potential approval or in the early stages of their commercial launch. And that are complementing or adjacent to the areas where we already have approved products.

We are looking for he mark it related assets that are in late stage clinical development and review for potential approval or in the early stages of their commercial launch and that are complementary or adjacent to the areas, where we already have approved products.

Speaker 2: Moving on to slide 19. As they've mentioned, generating and providing additional data benefits our product sales and helps us evaluate the expansion of our pipeline. I wanted to highlight a few abstracts that will be presented at the upcoming ash meeting in December .

Moving on to slide 19, as Dave mentioned generating and providing additional data benefits our product sales and helps us evaluate the expansion of our pipeline I wanted to highlight a few abstracts that will be presented at the upcoming ash meeting in December.

Speaker 2: included in abstract 2888 reporting post hoc analysis in a subset of patients with mutant IDH1 relapse or refractory AML or MDS. There were relapse or refractory to hematopoietic stem cell transplant, ivocytine or venetoclasts.

Included in <unk> included an abstract 28 88.

Reported post hoc analysis in a subset of patients with 90, H, one relapsed or refractory AML or Mds, there were relapsed or refractory to hematopoietic stem cell transplant I was tightened up corporate net of quest. The analysis suggests that the suite life alone or in combination with a society.

Speaker 2: The analysis suggests that oleutazutine alone or in combination with asocitidine may induce complete remissions in these patients.

May induce complete remissions in these patients.

Speaker 2: This answers a frequent question we were receiving from creating clinicians. And we are delighted to present this encouraging data in patients with these prior treatment.

This answers a frequent question we received from treating clinicians and we are delighted to present this encouraging data in patients with these prior treatments.

Speaker 2: ABSFRAC 1872 reports the results from a phase one slash two trial of all the student of alone or in combination with ASASIDID in a subset of 22 patients with mood 90H1 MDS. These encouraging results showed that all the student has clinically meaningful activity in patients with mood 90H1 MDS.

Abstract 18, 72 reports the results from our phase one slash two trial, although the student of alone or in combination with a decidedly in a subset of 22 patients with 90 H. One M. D. S. These encouraging results showed that older students as clinically meaningful activity in patients with 90, H one M B S.

Yes.

Speaker 2: Our perturbed key say will present abstract 2578 highlighting their phase three study, including long-term efficacy and safety of foster maddened bingit Japanese patients with primary ITP. These results support the use of foster maddened as a second-line treatment in patients with primary ITP.

Our partner to say what presented abstract twenty-five 78, hello, highlighting their phase III study, including long term efficacy and safety of Foster Mad.

Japanese patients with primary I T P.

These results support the use of post Imatinib as a second line treatment in patients with primary RTP.

And lastly, an abstract 32 47 is a trial in progress poster, providing an overview of the phase one b study of our tool to eight nine in lower risk Mds, which is enrolling well.

Speaker 2: And lastly, in abstract 3247 is a trial in progress post providing an overview of the phase 1B study of R2-289 in lower risk MDS, which is enrolling well. I will now spend a moment on that trial.

I will now spend a moment on that trial.

Moving on to slide 20.

Speaker 2: I wanted to spend a few moments discussing how we think our R1-4 inhibitor, R2-9, could address the unmet need in the treatment landscape for lower risk MDS. As you may know, MDS is a disorder of hematopoietal stem cells, resulted in dysplasia and in effect, hematopoietas in the bone marrow. For patients with lower risk MDS, risk include autoimmune abnormalities, cytopinesis, progression to AML, and even death.

I wanted to spend a few moments discussing how we think our Iraq, one four inhibitor or two even though it could address the unmet need in the treatment landscape for lower risk Mds as you May know MTS is a disorder of hematopoietic stem cells, resulting in dysplasia and ineffective him out of polices in the bone marrow for pace.

With lower risk Mds brisket include autoimmune abnormalities side of opinions progression to AML and even death.

Speaker 2: Patients undergo different treatments in the first line and second line setting, as shown in this slide. Duropo responses in the second line setting are not common. Subtits of patients show limited hematobragic, hematologic responses, and these agents result in significant adverse events.

Patients undergo different treatments in the personal line and second line settings as shown in this slide.

Durable responses in the second line setting are not common subsets of patients showed limited came out of Brexit.

Logic responses in these agents resulted in significant adverse events.

Speaker 2: Loss of response following second line therapy represents a poor prognosis for patients associated with significant morbidity and side opinions.

Lots of response following second line therapy.

Presents a poor prognosis for patients associated with significant morbidity inside of opinions.

Speaker 2: For lower risk MDS, who are refractory or resistant to current therapies, there remains a significant unmet need. And we believe our 29 has the potential to address this need in this underserved patient population.

For lower risk Mds, who are patients who are refractory or resistant to current therapies. There remains a significant unmet need and we believe our toy now it has the potential to address this need and misunderstood of patient population.

Yeah.

Speaker 2: Fly 21 shows our ongoing open label phase 1B study of R289 in patients with lower risk MDS.

Slide 21 shows our ongoing open label Phase one B study, a bar to ignore and in patients with lower risk Mds.

Speaker 2: The study continues to progress well. Enrollment in the third cohort is currently underway and we expect to have preliminary data in mid 2024. Thank you very much.

The study continues to progress well enrollment in this third cohort is currently underway and we expect to have preliminary data in mid 'twenty 'twenty four.

Moving on to slide 22.

Speaker 2: Our RIPK1 inhibitor, R552, is with our partner Eli Lilly. They are advancing this program in their phase 2A study in rheumatoid arthritis. With that, I will-

Okay. One inhibitor arc 552 is with our partner Eli Lilly they are in.

Betsy This program in their phase Iia study in rheumatoid arthritis.

With that I will turn the call over to James.

Speaker 4: Thank you, Ro. A month slide 24, for the third quarter of 2023, we shipped 2,551 bottles of Tovouese to our specialty distributors, resulting in $35.2 million of gross product sales. 2,412 bottles of Tovouese were shipped to patients' clinics while 139 bottles increased the levels remaining in their distribution channels at the end of the quarter.

Thank you Ralph I'm on slide 24 for the third quarter of 2023, we shipped 2551 bottles that probably to our specialty distributors, resulting in $35 $2 million of gross product sales 2412 bottles of Tottenham used were shipped to patients and clinics while one.

139 bottles increase the levels remain in their distribution channels at the end of the quarter.

Speaker 4: For the third quarter of 2023, we shipped 210 bottles of Rosalini to our specialty distributors, resulting in $3.4 million of gross product sales. 221 bottles of Rosalini were shipped to patients to clinics, while 11 bottles decreased the levels remaining in their distribution channels at the end of the quarter.

For the third quarter of 2023, we shipped 210 bottles of <unk> to our specialty distributors, resulting in $3 $4 million of gross product sales 221 bottle servers, whether you were shipped to patients and critics.

11 bottles decreased to levels remaining in our distribution channels at the end of the quarter.

Speaker 4: We reported net products sales in Tobelese at $24.5 million in the third quarter of 2023, a 27% increase compared to the same period in 2022. We reported net product sales fromers Lydia at $2.7 million in the third quarter of 2023.

We reported net product sales from top of we use a $24 $5 million in the third quarter of 2023, 27% increase compared to the same period in 2022, we reported net.

Product sales from Libya of $2 $7 million in the third quarter of 2023.

Speaker 4: Our net product sales from top of lease and reslidia were recorded net investment discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $11.5 million. So the third quarter of 2023, our growth and net adjustment for top of lease and reslidia was approximately 30.5% and 21% of gross product sales respectively.

Our net product sales from Brazil from top of Houston was media were recorded net of estimated discounts charge backs rebates returns co pay assistance and other allowances of $11 $5 million for the third quarter of 2023, our gross to net adjustment for top of receivers Libya was approximately 30 points.

5% and 21% of gross product sales respectively.

Speaker 4: Before we move on from net product sales, let me review our expectations for the fourth quarter of 2023. We continue to be pleased with the strength of our business in the third quarter and expect to see continued strength in our bottles shipped to patients and clinics for their remainder of the year.

Before I move on from net product sales, let me review our expectations for the fourth quarter of 2023, we continue to be pleased with the strength of our business the third quarter and expect to see continued strength in our <unk>.

<unk> shipped to patients and critics for the remainder of the year.

Speaker 4: In Cemental Aid, I would highlight through thought of 139 bottle increase in the levels remaining in our distribution channels at the end of the quarter of the table.

Incrementally I would highlight we saw a 139 bottle increase in the levels remaining in our distribution channels at the end of the quarter for travelers. These inventory levels are variable outside of our control.

Speaker 4: These inventory levels are variable and outside of our control.

Speaker 4: In commentally, we expect our growth to net adjustment in the fourth quarter of 2023, to be approximately 31% for top release, and approximately 21% for as many as.

Incrementally, we expect our gross to net adjustment in the fourth quarter of 2023 to be approximately 31% for top ways at approximately 21% first radio.

Speaker 4: On to the next slide. In addition to net product sales, for the three months ended September 30, 2023, Brage's contract revenues from collaborations were approximately $1 million, primarily from Grifols.

On to the next slide in addition to net product sales for the three months ended September 32020 free Brian just contract revenues from collaborations were approximately $1 million primarily from Brussels.

Speaker 4: Moving on to cost and expenses. Our cost of product sales was approximately $1.3 million for third quarter of 2023.

Moving on to costs and expenses our cost of product sales was approximately $1.3 million for third quarter of 2023.

Speaker 4: Total cost and expenses were $32.6 million in the third quarter of 2023, compared with $40.8 million in the same period of 2022.

Total costs and expenses were $32 $6 million in the third quarter of 2023, compared with $48 million in the same period of 2022.

Speaker 4: The decrease was primarily due to decreased research and development costs related to our phase three clinical trials of phosphamatinib and warm autoimmune hemolytic anemia and COVID-19.

The decrease was primarily due to decreased research and development costs related to our phase III clinical trials of fast imatinib in warm autoimmune hemolytic anemia, and COVID-19.

Speaker 4: Lower facility-related costs, and upfront payment to former therapeutics recorded in the third court of 2022.

Lower facility related costs, and an upfront payment to form a therapeutics recorded in the third quarter of 2022.

Speaker 4: The decreases were partially offset by increased research and development costs due to the time-interactivities related to our Iraq-1 for inhibitor program.

Decreases were partially offset by increased research and development costs due to the timing of activities related to our Iraq, one four inhibitor program.

Speaker 4: As you'll note, this is the second quarter where we've seen operating expense in the $32 million range. This operating expense level is the result of our focused development efforts, along with spending discipline across our entire organization. We're pleased with the financial leverage that we're seeing and have been able to successfully launch Reslydia in both the community and academic settings within this cost structure.

As you'll note. This in second quarter, we're seeing the operating expense and the $32 million range. This operating expense level as a result of our focused development efforts along with spending discipline across our entire organization.

We're pleased with the financial leverage that were seeing and they've been able to successfully launch for summit here in both the community and academic settings within this cost structure.

Speaker 4: We do expect to see an increase in operating expense in the fourth quarter due to certain programs and events. We look to maintain this focus and discipline approach into the future.

Or would you expect to see an increase in operating expense in the fourth quarter due to certain programs and events.

To maintain this focus and disciplined approach into the future.

Speaker 2: We ended the quarter with cash, cash equivalents, and short-term investments of $62.4 million. I'd like to certainly call back over to Raul. Oh, thank you, Dean. We are proud of the progress we have made through it so far in 2023. Retovalee sales delivering another strong quarter, mark by continued growth. We are executing on our launch of Rizlidia and driving awareness through our sales teams and engagements with the medical community at conferences, including the upcoming ash meeting in December .

We ended the quarter with cash cash equivalents and short term investments of $62 $4 million with that I'd like to turn the call back over to ROE Oh. Thank you Deane. We are proud of the progress we have made so far in 2020 three recover lease sales delivering another strong quarter marked by continued growth we are exit.

Hitting on our launch of its linear in driving awareness through our sales teams and engagements with the medical community at conferences, including the upcoming Ash meeting in December.

Speaker 2: continued growth of our products, coupled with diligent financial discipline, have resulted in a particularly good quarter. And we have made important progress towards our goal of reaching financial break.

<unk> growth of our products, coupled with diligent financial discipline have resulted in a particularly good quarter and we have made important progress towards our goal of reaching financial breakeven.

Speaker 2: This is an important objective, which I believe will set Rigel apart since it will allow us to grow and run our company with our own operation from our own operations in our own cache. We are creating a cell.

This is an important objective, which I believe will set rigel apart.

Since it will allow us to grow and run our company with our own operation from our own operations and our own cash we are creating a self sustaining company.

Speaker 2: With that, thank you for your interest in our progress in this quarter. And we will now open the call to your question.

With that thank you for your interest in our progress in this quarter and we will now open the call to your questions.

Yeah.

Speaker 1: Thank you. If you'd like to register a question, please press the star followed by the one on your telephone. You will hear a three-tone prompt to acknowledge your request.

If you'd like to register a question. Please press the star followed by the one on your telephone.

You'll hear a three towns prompt to acknowledge your request.

Speaker 1: If your question has been answered and you would like to withdraw your registration, please press the star followed by the two. One moment.

If your question has been answered and you would like to Australia registration. Please press the star followed by the two.

One moment please for the first question.

Speaker 1: The first question comes from the line of Yun Yang with Jeffries. Please visit your question.

The first question comes from the line of viewing Yang with Jefferies. Please proceed with your questions.

Speaker 5: Hi, this is Val and I'm sure you and thank you so much for taking our questions. So for the first question on Tava Lee's, could you please remind us on the market exclusivity expiration for...

Hi, This is Allen on for you and thank you so much for taking our questions. So for the first question on <unk> could you. Please remind us on the market exclusivity exploration for.

Speaker 5: Beverly's in the US, Europe and Japan. And then for reflidia, what the quarterly sales run rates of about $3 million do you expect gradual increases in sales? Or would there be an inflection point and how big do you expect the products to be? Thank you very much.

I believe in the U S Europe and Japan.

Then for Wrestlemania with a quarterly sales run rates of about 3 million.

Do you expect gradual increases in sales or would there be an inflection point and how big do you expect the product to product sales to be thank you very much.

I'll ask Ray to answer the first question is on top of least exclusivity in the U S and elsewhere.

Speaker 2: I'm gonna ask Ray to answer the first question on top of least exclusivity in US and all sorts.

Speaker 6: Yeah, we have a composition of matter patent for TAVALES that is with PTA and PTE, is expected to run until September of 2031. I'd have to check and get back to you on patent exclusivity in Japan.

Yeah.

We have a composition of matter patent for Teva lease that is with P. T. A P. T is.

We expected to run until September of 2031, I'd have to check and get back to you on X is a patent exclusivity in Japan and elsewhere I think it's a comparable or similar it is comparable I don't have that.

Speaker 2: I think it's comparable or similar. It is comparable. I don't have the experience.

Peter.

Speaker 2: On Residia, Dave, do you want to comment on our view?

Enbridge Lydia.

You want to comment on.

Our view yeah.

Speaker 3: Yeah, from a standpoint of Resilia, we are still earlier in the launch. You have to remember that clinicians have been using one IDH, one inhibitor for five years now. And so that's something that I think will take some time. But the other piece that I wanna make sure

Yeah from our standpoint to fat Wrestlemania we are still early in that launch you know you have to remember that our clinicians have been using one I D. H one inhibitor.

For five years now and so you know that's something that I think will take some time, but the other piece that I want to make sure I bring up here is that one part of our top top top of lease has been the patients and the other part is the refills you get the carryover that's going to be the same thing with <unk>.

Speaker 3: I bring up here is that one part of Taviles has been new patients and the other part is the refill QGETS carryover. That's going to be the same thing with Reslidia. Those new patients that we get, you know, because it has a duration of response, which is quite long for leukemia patients.

Its linear those new patients that we get you know because it has a duration of response, which is quite long for leukemia patients. We expect will have a good carryover business as we move into next year. So these patient starts.

Speaker 3: We expect we'll have a good carryover business as we move into next year. So these patients start.

Speaker 3: will help grow our business by themselves, but every time we have a new patient start, and they do well on RedSledia, and you'll remember that the composite complete remission is a importance of 40, more than 40%, they're going to stay on the product. We try to keep people on the product for at least six months before they judge whether it's had a response or not, and then because there are late response.

Will help grow our business by themselves, but every time, we have a new patient start and they do well on Rensselaer and you'll remember that the composite complete remission is upwards of 40 40 40 more than 40% are you know they're going to stay on the product we try to keep people on the product for it.

Six months before the judge whether it's had a response or not and then because there are late responses and then obviously if patients are responding they'll continue so that's why we're still very early.

Speaker 3: And then obviously if patients are responding they'll continue. So that's why we're still very early in this. We're only in the third full quarter of launch. And so we haven't really seen the benefit of that carryover with the patients that we've started already. I hope that helps put some color around why we expect Resolidious Hales to grow.

In this where we're only in the third full quarter of launch and so we haven't really seen the benefit of that carryover with the patients that we've started already I hope that helps us put some color around why we expect rents linear sales to grow.

Speaker 5: Got it. Thank you very much. If I may ask one follow up on some of the leads, currently what percent of the use is in second line ITP and what would you need in order to further capture the second line market? Thank you very much.

Got it. Thank you very much if I may ask one follow up until beliefs currently what percent of the presents.

He says in second line ATP and what would you need in order to further capture the second line market. Thank you very much.

Speaker 3: So the data we have by line of therapy comes from our RIDGE of OneCare database.

So the data we have by line of therapy comes from a range of wound care database and as I showed you showed.

Speaker 3: And as I showed you, showed last quarter, about 70% of our patients are in second and third line, about 30% of that.

As shared last quarter about 70% of our patients are in second and third line about 30% of that.

It is in second line and that stayed pretty consistent this quarter. So that's why we didn't really provide any update on that but.

Speaker 3: is in second line. And that stayed pretty consistent to this quarter, so that's why we didn't really provide any update on that. But we're really quite happy that, you know, in a market where retoxane and teapots are used.

But we're really quite happy that our.

You know in a market, where a rituxan and T. Pose are used very readily and have been for a long time that 70% of patients and at least in our database are getting top of lease either second or third line. So we'll continue to of course try to move.

Speaker 3: very readily and have been for a long time, that 70% of patients, at least in our database...

Speaker 3: are getting Tavalise either second or third live. So we'll continue to, of course, try to move patients.

Patients up but really you know I think the key is continuing to grow new patient starts and that's what we can do it so hopefully that answers your question.

Speaker 3: But really, I think the key is continuing to grow new patient starts and that's what we've been doing. Hopefully that answers your question.

Thank you so much.

Thank you.

Thank you. The next question comes from the line of Kristen <unk> with Cantor Fitzgerald. Please proceed with your questions.

Speaker 1: The next question comes in line of Kristen Posca with Cantiver-Charled. Please just use your question.

Speaker 7: Hi, this is Rick Miller on for Kristen. Thanks for taking our questions. Given the commercial strategy, sort of dovetailing tovelies with Res Lydia and the institutional sales force focus there, do you have any commentary on how the approach it has this year may differ from your approach in the past or how you're thinking about approaching the sort of educational aspects of the conference, given the new institutional sales force approach?

Hi, This is Rick Miller on for Kristen Thanks for taking my questions.

Given the commercial strategy sort of Dovetailing tallis with Fred's Lydian the institutional sales force focus there do you have any commentary on how the approach at Ash. This year may differ from your approach in the past or how you're thinking about approaching sort of educational aspects of the conference given the new institution.

Sales force approach.

Speaker 3: Good question, Rick. Thank you. Steve, do you want to come in? Yeah, I will say we are bringing our entire institutional team to ash because we do think it's an important opportunity for them to interact with their customers.

Yeah. Good question Rick Thank you.

Do you Wanna comment Yeah, I, all I will say we.

We are bringing our entire institutional team to ash, because we do think it's an important opportunity for them to.

Interact with their customers. The fact is as you know boost.

Speaker 3: The fact is, is, you know, most important hematology traders can tend to ask. And so it's a very specific audience, especially AML traders. And so we will be deploying our team there.

Important hematology treaters tend to ash and so it's a very specific audience, especially AML treaters and so we will be deploying our team there.

Speaker 8: You know Rick, a year ago we got the product approved just days before the ash meeting and it's remarkable we were able to have be ready and have information of their on the boot.

You don't wake up a year ago, we got the product approved just days before the ash meeting and it's remarkable we were able to be ready and have information they're at the booth.

Lydia and since then we create in the middle of this year, we created the institutional business team to help us penetrate the academic centers. So we're very very much different in terms of preparedness this year than a year ago and so it shouldn't be an exciting meeting for us being able to interact with many of those academic centers, but also lots of community.

Speaker 8: And since then, we create in the middle of this year, we created the institutional business team.

Speaker 8: to help us penetrate the academic centers. So we're very, very much different in terms of preparedness this year than a year ago.

Speaker 7: based clinicians for both of these products. Very, very different. We have data also being presented that I think is very compelling and earlier this year at EHA and in other places, we've published data supporting the use of ResLidia. So we really have a very different, I guess, approach data and individuals to share this information at this ash meeting relative to a year ago. Great, and maybe just one follow-up with the ash abstract.

Based clinicians for both of these products are very very different we have data also being presented that I think is very compelling and earlier this year at a E. L. L and in other places we have published data supporting the use of Reds. Lydia. So we really have a very different so I guess approach data and.

And individuals' to show this information at this ash meeting relative to a year ago.

Speaker 7: Great, and maybe just one follow up with the ASHAB extract, specifically the MDS analysis. Can you talk a little bit about how you're thinking about the IDH1 positive prevalence in the MDS population and how this relates to what you're seeing in AML? Thank you, and looking forward to seeing the team in San Diego.

Great and maybe just one follow up with the Ash abstracts, specifically B M. D. S. A M guess analysis can you talk a little bit.

About how you're thinking about the I T. H, one positive prevalence in the Mds population and how this relates to what you're seeing in AML. Thank you and looking forward to seeing the team in San Diego.

Yeah, I'll I'll comment, Dave do you want to comment as well.

Speaker 8: Yeah, I'll comment. Dave, you want to comment as well? You know, MDS is an attractive opportunity. We've seen IDH1 inhibitors work in this area. So it provides some exciting opportunities. Just to remind you, in the phase two study done by our colleagues in FORMA, it included patients with MDS. So we have some idea on that opportunity already with, I think, 22 patients. In the abstract presented in it.

This is an attractive opportunity and we've seen I D. H one inhibitors work in this area. So it's a provide some exciting opportunities just to remind you in the a phase II study done by our colleagues in pharma. It included patients with M. D. S. So we have some idea on that the opportunity already with the I think 22 patients.

In the abstract presented it helps yes.

Speaker 7: And just Rick, could you just repeat the first part of your question? I just want to make sure I got that right. Yeah, more around prevalence and just sort of, you know, market size in the MDS population versus AML.

And just Rick could you just repeat the first part of your question I just wanted to make sure I got that right.

Yeah more around prevalence and just sort of a you know market size in the Mds population versus AML.

Speaker 8: I don't have those specifics right here with me, but it is a smaller population than the AML population. Yeah, it's just smaller, I think, but I think the percentage of IDH positive is a bit higher than an AML, but it's still the smaller population on the whole. Yeah.

Yeah, I don't have those specifics right here with me, but it is a smaller population in the AML population you know, it's a smaller I think but I think the percentage of by D. H positive is a bit higher than in AML, so, but it's still a smaller population on the whole.

Great. Okay. Thank you very much.

Thank you Rick.

Next questions are from the line of Yigal knock with with Citi. Please proceed with your question.

Speaker 1: Next questions are from the line of you got knacklets with city. Please see you there.

Speaker 9: I think this is Carly on Furia Gaul. Thank you for taking our questions. We had a few follow-ups on Rizlidia.

I think this is carly on for Yigal. Thank you for taking our question we had a few follow ups on <unk>.

Speaker 9: I'm wondering if you can comment on the contribution from new versus existing patients.

First wondering if you can comment on the contribution from new versus existing patients during the third quarter and approximately what percent chair of the market do you believe you have within that incident patient population and the.

Speaker 9: during the third quarter and approximately what percent share of the market you believe you have within the incident patient population. And then second, of the different label expansion opportunities that you outlined, just curious if there's one that you would maybe highlight as the highest priority and when we might get more details on your future plans.

Then second of the different label expansion opportunities that you outlined just curious if there is one that you would maybe highlight as the highest priority and when we might get more details on your future plans there.

Yeah.

Steve do you want to comment on rich linear contribution new versus established patients and are sure of incident population.

Speaker 8: They do want to comment on Rizlidia contribution new versus established patients and share of incident population.

Yeah, So if you're looking at our total bottles shipped in Q3.

Speaker 3: Yeah, so if you're looking at our total bottles ship.

Speaker 3: in Q3. Obviously the majority of those were carryover from previous. I have to, let me see here, it's probably generally maybe two thirds to three quarters carryover and about a quarter to a third is

Obviously, the majority of those were a carryover from previous I'd have to let me say here, it's probably generally maybe two thirds to three quarters carryover and about a quarter.

Quarter to a third is new.

Speaker 3: new and again that always depends on when you get those new patients.

New and again that always depends on when you get those new patients. We got our new patients are a lot of them as I said in September. So that's why I think you know that that number is like the weight or is the way. It is so I hope that makes sense.

Speaker 3: We got our new patients, a lot of them, as I said, in September . So that's why I think that that number is like the way, or is the way it is. So I hope that makes sense. But the majority this quarter was carryover. And again, a lot of that is because our new patients, really, because it is kind of lumpy, showed up in September .

But the majority this quarter was carryover and again a lot of that is because our new patient really because it is kind of lumpy showed up in September.

Going to your second question in terms of share and there's you know if if you do this say you're talking about maybe 250 patients a quarter you heard from our first quarter at launch we were around 30 patient. So you know.

Speaker 3: On your second question in terms of share of those, you know, if you do this, you're talking about maybe 250 patients a quarter, you heard from our first quarter on launch, we were around 30 patients. So, you know, we think we're probably in that double digit share of incident new patients.

We think we're probably in that double digit share of incident patients.

And on the unbelievable expansion priority you know all three of those that I mentioned and there are others in fact in other segments of AML.

Speaker 8: And on the label expansion priority, you know, all three of those, I mentioned that there are others, in fact, in other segments of AML, in Gleoma, and MDS are attractive and different, one to the other. AML, we know the product works and is shown a benefit in the relapse for fractory setting. Obviously, other opportunities within that, patients of maintenance and first line are things that we're thinking about.

In glioma, and MTS are attractive and a different one to the other AML. We know the product works and has shown a benefit in the relapsed refractory setting obviously other opportunities within that patient so maintenance and first Florida or are things that we're thinking about.

Speaker 8: In addition, Golioma is a sizeable size of all opportunity and is so poorly poorly treated today That is a very exciting opportunity a larger opportunity perhaps

In addition, our glaucoma is a sizeable sizeable opportunity in just so poorly poorly treated today.

<unk> is a very exciting opportunity a larger opportunity, perhaps and MTS, while smaller as we mentioned just a minute ago, Oh, an area with significant medical need as well both in low risk and high risk Mds. So there really is a highly varied array of different opportunities for all of this and clearly we are.

Speaker 8: And MDS, you know, while smaller, as we mentioned just a minute ago, an area with significant medical need as well, both in low risk and high risk MDS. So there really is a highly varied array of different opportunities for all the students. And clearly, we are going to focus on a subset of those and do so in a focused, efficient, cost-wise manner. Perhaps with some cases with academic and government partners.

With your focus on a subset of those and do so when they focused efficient coastwise manor, perhaps with some cases with the academic and government partners.

Okay, Great. That's helpful. Thank you very much.

Thank you.

Speaker 1: The next question is in the line of drill paint Guinness with H.E.Wane, right? Please receive it.

The next question is from the line of Joe kind of get Us with H C. Wainwright. Please proceed with your question.

Speaker 10: Hey everybody, good afternoon, thanks taking the question. So I was curious first, wanted to go back to Cavalese patient populations. And I guess I'll ask the question, but I don't know if you have this level of granularity in the data you collect. So in the second line, or moving to second,

Hey, everybody. Good afternoon. Thanks for taking the question. So I was curious first wanted to go back to private lease Ah patient populations and I guess I'll ask the question, but I don't know if you have this level of granularity in the data you collect so in the second line or moving to second line patients do you have data.

Speaker 10: You have data that show, for example, patients that are, that you're replacing T-POs or say you're prescribing a Tavillese in lieu of T-POs. Do you have that level?

That show for example, patients that are that you're replacing T pose or say, you're prescribing Teva lease in lieu of T. Posts do you have that level of granularity that are say rituxan.

Okay.

Speaker 3: Well, I just, you know, to be clear where our data comes from is rocked. We actually, because we have those histories, we know what line of therapy that is. So we don't, but we don't have is kind of what they would have intended to you.

Well I just say you have.

To be clear, where our data comes from is rock, we actually because.

We have those histories, we know what line of therapy that is so we don't but we don't have is kind of what they would have been tempted to use. So we're mixing two kind of different things. There. The data that we are sharing in terms of 30% of those patients that are going through rock, our second line, but we don't know what.

Speaker 3: So we're mixing two kind of different things there, the data that we are sharing in terms of 30% of those patients that are going through rock, our second line, so we don't know what they would have used had they not chosen top of least. Does that make sense? What are they doing?

They would've used had they not chosen top of lease does that makes sense.

Yeah.

Speaker 3: So from our ATU, I think, you know, those clinicians who do use it second line, those are clinicians who've had experience with Tovelies like how Tovelies works, and they just, they tend to move it up because it's very predictable. So that's probably the best way I can say it. I don't wanna...

So from our eight to you I think you know those clinicians who use it second line those are clinicians who have had experience with probably like how <unk> works and they just they tend to move it up because it's very predictable. So that's probably the best way I can say it.

I I I don't want a a jump to any conclusions about where our second line business is coming from in terms of what product they would have chosen.

Speaker 3: jump to any conclusions about where our second line business is coming from in terms of what product they would have checked.

Speaker 10: That's completely fair, appreciate that. And then with regard to Resolidia, obviously, the launch continues to be...

No. That's that's completely fair I appreciate that and then with regard to Reds Lithia, obviously, the the launch continues to be impressive and I guess I guess I wanted to touch upon any potential real world safety signals.

Speaker 10: I guess I wanted to touch upon any potential real world safety signals.

Signals for example, with regard to differentiation syndrome. Since it is one of the warnings on the label is there anything to discuss there and you know the fact that you know physicians are becoming much more adept at handling that.

Speaker 10: Is there anything to discuss there and you know the fact that you know?

No I wouldn't say, we have anything that indicates like this is a class effect to black box warning across the class boats with them flip three inhibitors as well as our I D. H one inhibitors 90 age too so it's a class effect.

Speaker 3: No, I wouldn't say we have anything that indicates, look, this is a class effect into black box wording across the class both with foot three inhibitors as well as IDH1 inhibitors and IDH2. So it's a class effect and we have not heard anything or have reasons to believe that our differentiation syndrome would be a different shader for...

And that we have not.

Heard anything or have reason to believe.

That our differentiation syndrome would be a differentiator for.

Speaker 3: for Res Lydia. That said, we do believe that, you know, it is a different toxicity profile, and we do believe that the...

For Reds Lydia.

That said, we do believe that you know it is a different toxicity profile and we do believe that the the law.

Speaker 3: the lack of any reference to needing to do cardiac monitoring in our label is a differentiator for certain patients who might have cardiac comorbidities. So that continues to be something that we will look into and potentially, hopefully, in the future with real-world evidence, help to show that.

Lack of any reference to needing to do cardiac monitoring in our label is a differentiator for certain patients who who might have a cardiac comorbidities. So that continues to be something that we will look into and potentially hopefully in the future with real.

A world evidence helped to show that.

I appreciate the color. Thank you very much.

Thank you.

Speaker 1: Thank you. There are no further questions at this time, and I would like to turn the floor back over to Mr. Raoul. Rodriguez for closing comments.

There are no further questions at this time and I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Speaker 8: Thank you. This quarter was a really good, very good one. We grew our products very nicely and we're happy with that. We made progress on our financial goals as well. So we're very pleased where we are. So with that, I'd like to close by thanking everyone of you for your continued interest and support of Ryzo. And as always, I'd like to thank our employees for their commitment to improving the lives of patients. They work hard every single day. And with that, look forward to updating you on future calls. Have a great day.

This quarter was a really good very good one we grew our products very nicely and we're happy with that we are making progress on our financial goals as well. So we're very pleased where we are so with that I'd like to close by thanking everyone of you for your continued interest and support of Rigel and as always I'd like to thank our employees for their.

Commitment to improving the lives of patients they work hard every single day.

And with that I look forward to updating you on future calls have a great day.

Speaker 1: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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

Yeah.

Yeah.

Yeah.