Q3 2024 Rigel Pharmaceuticals Inc Earnings Call
Speaker Change: Greetings and welcome to Ryju Pharmaceuticals financial conference call for the third quarter, 2024. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation.
Speaker Change: 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, RIDU's Executive Vice President, General Counsel, and Corporate Secretary.
Thank you, Mr. Furey. You may begin.
Ray Furey: Hello, welcome to our third quarter 2024 financial results and business update conference call.
Ray Furey: The financial press release for the third quarter of 2024 was issued a short while ago and can be viewed along with the slides for this presentation in the news and events section of our investor relations site on risal.com.
Ray Furey: A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2020.
Ray Furey: Q3 quarterly report on Form 10-Q on file with the SEC.
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.
Ray Furey: At this time, I'd 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 Dave Santos, our Chief Commercial Officer, Lisa Rojkjaer, our Chief Medical Officer, and Dean Schorno, our Chief Financial Officer.
Ray Furey: I will begin on slide four with an overview of Rigel's business and our third quarter results.
Ray Furey: In the first three quarters of the year, we made significant progress in our strategy to grow our hematology and oncology business. Our corporate strategy is focused on three main objectives.
Ray Furey: 1. Expanding our commercial portfolio and increasing product sales 2. Advancing and growing our pipeline through strategic collaborations and importantly internal pipeline development and 3. Maintaining financial discipline. I will now summarize each of these
Ray Furey: Firstly, in the third quarter, we generated strong growth across our commercial portfolio with a total net sales of $38.9 million.
Ray Furey: This was up 44% compared to the third quarter of 2023. This robust revenue growth was driven by the addition of Gabretto, which generated $7.1 million in net product sales for its first full quarter with Rizal, as we transitioned the majority of patients and prescribers into our network.
Ray Furey: In addition, we saw continued year-over-year growth for Tavalis and ResLydia, with both achieving another record quarter for bottle ship to patients and clinics.
Ray Furey: We continue to expand our product presence outside the U.S. as well this quarter with a new Kisei agreement to develop and commercialize Resolidia in Japan, the Republic of Korea, and Taiwan.
Ray Furey: This agreement included a $10 million upfront payment that we received in Q3, and the potential for up to $152 million in future development, regulatory, and commercial milestone payments.
Ray Furey: Secondly, regarding our objective to grow our pipeline, we continue to advance the development of R289, our dual IRAC1 and IV inhibitor, in a phase 1b study in lower-risk MDS.
Ray Furey: Initial safety and efficacy data from that trial was published in an ASH abstract earlier this week and we look forward to sharing additional data from a more recent data cut at the ASH meeting in December.
Also at AST we'll have additional data for Olustegno.
Ray Furey: Our strategic collaborations with MD Anderson and CONNECT are progressing well. These trials provide us with the opportunity to explore reslydia in a broad range of IDH1 mutant cancers in a cost and time efficient manner.
Ray Furey: Our first trial with MD Anderson, evaluating Rizlidia in a combination with two other agents in patients with mutant IDH1-AML enrolled its first patient in September.
Ray Furey: And as we did with Brasilidia and Corvetta earlier this year, we continue to evaluate opportunities to in-license or acquire late-stage hematology and or oncology assets to further expand our portfolio.
Ray Furey: In 2025, we will discuss our development plans for both R289 in lower-risk MDS and ulacitinib.
Ray Furey: Lastly, as we execute our strategy to grow our business, we're doing so in a financially disciplined manner. Our strong commercial execution and cost-effective approach to clinical development has enabled us for the first time to generate positive third quarter and year-to-date net income.
Ray Furey: In summary, in the third quarter, we made significant progress in growing our business while achieving net income breakeven. We are well positioned to continue to drive value as we head into 2025.
Ray Furey: And with that, I'll turn the call over to Dave to provide a commercial update. Dave? Thank you, Raul. We are very pleased with the strong growth in revenues in Q3.
Dave Santos: Moving to slide 6, you see how our quarterly and annual sales have evolved since 2021. We have grown each quarter's sales over the previous year, and that growth continues, particularly from last year to this year.
Dave Santos: We started the first quarter of 2023 with $23.8 million and are now reporting $38.9 million in the third quarter of 2024.
Dave Santos: That's an incremental $15.1 million, representing 63% growth in quarterly revenue over 7 quarters.
Dave Santos: That growth has been driven by our strong commercial execution in consistently building quarterly demand for Top of Lease and driving broader awareness of ResLydia through the first two years of its launch.
Dave Santos: The addition of Gabretto and our ability to successfully transition it to our portfolio has also significantly expanded our top line.
Dave Santos: Compared to the third quarter of 2023, we generated 44% growth in the third quarter of 2024. As you can see, we're well on our way to delivering a record year of net product sales.
Dave Santos: Our commercial team is focused on execution, driving continued momentum for Tavalis, improving both institutional and community demand for Renslydia, and successfully transitioning all Gavretto patients and accounts to Rigel labeled products.
Dave Santos: My sincere thanks to the entire team for all their hard work to grow our business in 2024.
Dave Santos: Moving to slide 7, I'll first discuss our performance with Tavalisse in the third quarter.
Dave Santos: On slide 8, you'll see our FDA-approved indication, which is for adult patients with chronic immune thrombocytopenia, or CITP, who've had an insufficient response to a previous treatment.
Dave Santos: Moving to slide 9, I'm pleased to report another strong quarter for Tavalese, with 2,797 bottles shipped to patients and clinics in the third quarter, a 16% increase versus the third quarter of 2023, and our eighth consecutive quarterly record high.
Dave Santos: We sold 2,793 bottles to our distribution network, resulting in $26.3 million in net product sales during the third quarter, an 8% increase from the same period last year.
Dave Santos: We continue to grow Tavalee's demand, both through refills from patients who stay on the product and new prescriptions for patients who are trying Tavalee's for the very first time.
Dave Santos: Moving to slide 10, now I'd like to take a few minutes to discuss our growing ResLydia sales.
Dave Santos: On slide 11, you'll see our FDA-approved indication for Reslydia, which is for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.
Dave Santos: Moving to slide 12, we shipped 444 bottles of Reslydia to patients and clinics in Q3, more than doubling the demand generated in the same period a year ago.
Dave Santos: This resulted in $5.5 million in third quarter net product sales.
Again, more than doubling compared to the prior year.
Dave Santos: We continue to stay focused on improving ResLydia adoption both in institutions and the community by raising awareness of ResLydia's efficacy, particularly in patients who have failed upfront therapy with venetoclax.
Dave Santos: Moving to slide 13, we are incredibly excited about our work to expand access to illicit nib in markets outside the U.S.
Dave Santos: We're expanding our partnership with Kise, who currently markets and distributes tavelis in Japan, to include a license agreement to develop and commercialize ResLydia in Japan, Korea, and Taiwan.
Dave Santos: We believe Kise is the right partner in these markets as we further our goal to make ResLydia accessible globally.
Dave Santos: And we're continuing to explore other opportunities for partnerships outside the U.S. to bring this beneficial product to AML patients in need in other markets around the globe.
Dave Santos: Moving to slide 14, I'll now discuss our third-quarter performance for Gevretto, the first full quarter in which Gevretto was available through Rigel.
Dave Santos: which include the treatment of adult patients with metastatic RET fusion positive non-small cell lung cancer, as well as adult and pediatric patients 12 years of age and older with advanced RET fusion positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory.
Dave Santos: For the first full quarter with DevReto in our portfolio, we shipped 717 bottles to patients in clinics and sold 752 bottles of DevReto.
Dave Santos: Please note that Gevretto is available in bottles of either 60 or 90 count capsules and for reporting purposes, we report the total number of 60 count equivalent bottles.
Dave Santos: This resulted in $7.1 million in Gevretto third quarter net product sales. We have now sold a total of $9 million of Gevretto since transitioning it in late June.
Dave Santos: We are very happy that both the first full quarter of demand and net sales Indicate that we are successfully transitioning over defretto patients prescribers and accounts to Rigel's distribution network
Dave Santos: Moving to slide 17, I'd like to wrap up my comments with some early insights on what we saw during our first full quarter with Gebreto.
Dave Santos: We are incredibly pleased with the progress we've made to ensure both current patients taking Gabrano as well as those newly prescribed continue to have access without interruption and that prescribers can feel confident knowing that their patients can continue getting the therapy they need.
Dave Santos: Based on the first full quartership in Gibretto to patients in clinics, we have seen an exceptionally smooth transition of patients through our hub, Rigel OneCare, and the specialty pharmacies in our network.
Dave Santos: And we have also seen solid ordering by many of the direct accounts we had expected to order through our specialty distributors.
Dave Santos: Our distributors have shipped 320 bottles to accounts representing about 45% of our business.
Dave Santos: Specialist Pharmacies ship 397 bottles to patients, making up most of our business.
Dave Santos: We did expect that there would be more of our business coming through direct accounts and have noticed that a handful of expected top direct accounts still have not yet placed an order.
Dave Santos: In addition, in this specialty pharmacy data, we are seeing that the majority of patients are prescribed Gifredo below the standard dose of 400 mg once a day.
Dave Santos: Indicating we may have an opportunity to reinforce dosing and administration, and particularly the starting dose of Gibrato.
Dave Santos: Overall, Gevretto, Reslydia, and Pavlis have all contributed to our strong year-over-year revenue growth and we look forward to further expanding our impact on patients with our growing portfolio as we move forward to 2025.
Speaker Change: Thanks for your attention and I will now turn the call over to Lisa to discuss our development progress. Lisa?
Thanks, Dave.
Lisa Rojkjaer: Moving to slide 19, I'd like to begin by highlighting a series of abstracts that will be presented at posters at the upcoming ASH Annual Meeting in December.
Speaker Change: As Raul mentioned, initial data from the dose escalation part of our Phase 1b study of R289 in patients with relapsed or refractory lower risk MDS will be presented during the poster session on Monday, December 9th.
Speaker Change: Updated results using a data cutoff date of October 25th will be shared at the meeting.
Speaker Change: Additionally, a number of presentations related to lutecidin abuse in patients with IDH1-mutated AML and MDS are planned.
Speaker Change: Moving to slide 20, we continue to execute on our strategy to expand our hematology and oncology pipeline. First, we're making meaningful progress advancing elutacidinib into new clinical indications alongside our partners MD Anderson and the Connect Cancer Consortium.
Speaker Change: We believe lutecidinib has potential in several cancers where mutated IDH1 plays a role, such as additional AML segments, myelodysplastic syndrome, or MDS, and glioma, either as monotherapy or in combination.
Speaker Change: One clinical trial is now active under MD Anderson collaboration, and we're continuing to advance elutacidinib and glioma with CONNECT.
Speaker Change: R289 is our novel dual IRAC1 and 4 inhibitor that is currently being evaluated in a Phase 1b study in patients with relapsed refractory lower risk MDS.
Speaker Change: Enrollment in the 5th dose level is ongoing. We expect that the DLT observation period will be completed within December.
Speaker Change: Products that are late stage, possibly with registrational data, seem to have registrational data, or more advanced, and products that can leverage our hematology and oncology infrastructure.
Speaker Change: As demonstrated with our acquisitions of Aluta-Citnip and Pral-Citnip, our goal is to continue to find assets that align with our organization pipeline and ability to execute.
Speaker Change: Slide 21 provides an overview of our strategic alliance with the M.D. Anderson Cancer Center to advance leucocystinib more broadly into AML, MDS, and beyond.
Speaker Change: We're very proud of this collaboration and have previously shared that in September, the first patient was enrolled in a phase 1b2 triplet therapy trial in IDH1 mutated AML, evaluating elutocidinib, dicitabine, and venetoclox.
Speaker Change: It is also planned to evaluate a lutecidinib as a monotherapy in patients with IDH-mutated CCUS and lower-risk MDS.
Speaker Change: We expect these trials to position us to conduct a subsequent registrational trial or trials.
Speaker Change: Moving to slide 22, another important development collaboration we have is with the Connect Global Neuro-Oncology Consortium to conduct a phase 2 trial in patients with IDH1 mutated high-grade glioma.
Speaker Change: Gliomas account for around 30% of CNS tumors in children, adolescents, and young adults.
Speaker Change: Approximately a third of these are high-grade gliomas, translating to approximately 800 to 1,000 new cases each year in the U.S. High-grade gliomas are a leading cause of cancer-related death in adolescents and young adults.
Speaker Change: Despite available therapies, the 5-year survival of this population is less than 10%.
Speaker Change: Based on preliminary safety and efficacy results from a Phase 1b2 clinical trial evaluating elutacidinib in heavily pretreated patients with relapsed or refractory IDH1-mutated glioma, we believe that elutacidinib has potential in glioma treatment.
Speaker Change: A Phase II study of Belutacidinib in combination with Temozolomide, called Target D, will be included as a treatment arm in Connect's Target Study, a molecularly guided Phase II umbrella clinical trial for high-grade glioma.
Speaker Change: The goal of this study is to determine whether the combination of elutocidinib and temozolomide followed by elutocidinib monotherapy can prolong the progression-free survival of patients with IDH1-mutated high-grade glioma when given following radiotherapy.
Speaker Change: We, along with Connect, are excited about elutacidinib's potential to provide a much-needed new treatment option to this underserved patient population. We anticipate this trial will be activated by the end of this year.
Speaker Change: Next, I'd like to provide some background information on our clinical development program in lower risk MDS with our novel dual IRAC1-4 inhibitor R289, which you will see on slide 23.
Speaker Change: Lower risk MDS is an area of high unmet need in a primarily elderly patient population facing progressive cytopenias, particularly anemia, resulting in transfusion dependency, an increased risk of infections, and a risk of progression to acute leukemia.
Speaker Change: Transfusion burden is high with more than 80% of patients requiring red cell transfusions as supportive therapy.
Speaker Change: Long-term survival rates are poor due to transfusion burden and its associated morbidities.
Speaker Change: As well as a lack of curative therapies other than allogeneic stem cell transplantation, which a minority of patients are eligible for due to their advanced age and underlying health conditions.
Speaker Change: The primary goal of therapy is to reduce transfusion burden. Initial treatment options include ESAs if eligible and lenalidomide for Dell 5Q patients.
Speaker Change: For transfusion-dependent patients, lusparicept and ametastat have recently been approved post-ESAs or for ESA-ineligible patients.
Speaker Change: In later lines of therapy, durable responses are difficult to attain and toxicity becomes more of an issue.
Speaker Change: There are no standard therapies for lower risk MDS patients with recurrent or refractory disease. In fact, hypomethylating agents were approved about 20 years ago, underscoring the need for new, safe, effective therapies for these patients.
Speaker Change: We believe that R289 has the potential to address the unmet needs in this patient population by targeting inflammatory signaling.
Speaker Change: Moving to slide 24, I'd like to highlight why we're excited about R289.
Speaker Change: Disregulation of the immune and inflammatory signaling pathways is associated with MDS.
Speaker Change: IRAC1 and IV activation, independent of this pathway, may also lead to persistent inhibition of hematopoietic cell differentiation.
Speaker Change: Co-targeting both IRAC1 and IV may fully suppress inflammation and restore hematopoiesis and MDS. Clinically, IRAC4 inhibitors and MDS and AML have thus far shown only modest activity supporting this concept.
Speaker Change: In preclinical and healthy volunteer studies, R835, a dual IRAC1-4 inhibitor, was previously shown to suppress pro-inflammatory cytokine production.
Speaker Change: R-289 is an oral prodrug that is rapidly converted to R-835 in the gut that is currently being evaluated in lower risk MDS.
Speaker Change: Slide 25 shows the design of our ongoing open-label Phase 1b study of R289 in patients with relapsed refractory lower-risk MDS which has a dose escalation phase with a standard 3 plus 3 design and a dose expansion cohort for confirmatory safety.
Speaker Change: The primary endpoints for this trial are safety and selection of the recommended dose for expansion. And secondary endpoints include hemologic improvement, response rates, and PK.
Speaker Change: Based on emerging data from the study, we've recently included two additional cohorts with twice daily dosing regimens for a total of five dose levels.
Speaker Change: The study continues to progress well and enrollment in the fifth dose level, a split dose of 500mg and 250mg daily, is nearing completion.
Speaker Change: We expect the DLT evaluation period of this dose level will be completed in December. We're encouraged by the preliminary safety and efficacy data from the study thus far in this elderly patient population with a high transfusion burden, as summarized in the recently published ASH Abstract.
Speaker Change: Lastly, on slide 26, our RIK-K1 inhibitor programs are progressing well with our partner Lily. RIK-K1 is implicated in a broad range of inflammatory cellular processes and plays a key role in tumor necrosis factor signaling.
Speaker Change: Ocaducertibs, our non-CNS penetrant GRIPA1 inhibitor, previously referred to as R552, is currently being studied in an adapted phase 2A-2B clinical trial in up to 380 patients with active moderate to severe rheumatoid arthritis.
Speaker Change: Our preclinical CNS penetrant RIPK1 inhibitor program is also progressing toward lead candidate nomination.
Speaker Change: We're excited about the progress of our programs and their broad potential in rheumatoid arthritis and other immune and CNS diseases.
Speaker Change: Now, I'll pass the call to Dean to discuss our financial results for the quarter.
Dean Schorno: Thank you Lisa. Slide number 28. During the third quarter we shipped two thousand seven hundred ninety three bottles of Tavolis to our specialty distributors.
2,797 bottles of tablilis were shipped to patients and clinics.
Dean Schorno: Well, four bottles decreased the levels remaining in their distribution channels at the end of the quarter.
Dean Schorno: We shipped 429 bottles of Rosalidia to our specialty distributors. 444 bottles of Rosalidia were shipped to patients at clinics, while 15 bottles decreased the levels remaining in our distribution channels at the end of the quarter.
Dean Schorno: We shipped 752 bottles of Gavretto to our specialty distributors. 717 bottles of Gavretto were shipped to patients and clinics, while 35 bottles increased the levels remaining in our distribution channels at the end of the quarter.
Dean Schorno: We reported net product sales from Tavolis of $26.3 million in the third quarter, a growth of 8% compared to $24.5 million in the same period in 2023.
Dean Schorno: We reported net products to Alzheimer's Lydia of $5.5 million in the third quarter, a growth of 107% compared to $2.7 million in the same period of 2023.
Dean Schorno: Finally, we reported net product sales she's got run out of $7 $1 million in the third quarter, our first full quarter of them read ourselves our net product sales from top movies frozen.
Dean Schorno: And finally, we reported net product sales from Gavretto of $7.1 million in the third quarter, the first full quarter of Gavretto sales.
Dean Schorno: Our net product sales from Tavalisse, Rizzolitti, and Gabretto were recorded net of estimated discounts, chargebacks, rebates, returns, co-pay assistance, and other allowances of $17.4 million.
Dean Schorno: Originally the inkjet Roto were recorded net of estimated discounts charge backs rebates returns co pay assistance and other allowances of $17 $4 million.
Dean Schorno: For the third quarter of 2024, our gross to net adjustment for Tahoe Radian got Red Arrow was approximately 36%, 22% and 15% of gross product sales respectively.
Dean Schorno: For the third quarter of 2024, our gross net adjustment for Tavolese, Rizzolini, and Gavretto was approximately 36%, 22%, and 15% of gross product sales, respectively.
Dean Schorno: We'd like to highlight that during the fourth quarter, we made certain changes to our distribution channel arrangements photography's.
Dean Schorno: We'd like to highlight that during the fourth quarter, we made certain changes to our distribution channel arrangements for Tavolis that will result in continued high-quality access while reducing our distribution costs and favorably impacting our gross demand adjustment into the future.
Dean Schorno: Resulting in continued high quality access or reducing our distribution costs and favorably impacting our gross to net adjustment in the future.
While this change is not expected to impact our bottles shipped to patients at clinics during the quarter. We may see a reduction in bottles remaining in our distribution channels at the end of the quarter as inventories normalize finally for the fourth quarter, we expect our gross to net adjustment for Tommy's brisk Radian got rider to be approximately 35% 20.
Dean Schorno: While this change is not expected to impact our bottle ship to patients at clinics during the quarter, we may see a reduction in bottles remaining in our distribution channels at the end of the quarter as inventories normalize.
Dean Schorno: Finally, for the fourth quarter, we expect our gross-to-net adjustment for Tavalis, Rizzolitti, and Gabaretto to be approximately 35%, 21%, and 22% of gross product sales, respectively.
Dean Schorno: 1% up from 22% of gross product sales respectively.
Dean Schorno: Onto the next slide.
On to the next slide.
Dean Schorno: In addition to net product sales of our contract revenues from collaborations were $16 $4 million in the third quarter contract revenues from collaborations consisted of $13 million from say $3 $3 million referrals from $100000 for Medisoft.
Dean Schorno: In addition to net product sales, our contract revenues from collaborations were $16.4 million in the third quarter. Contract revenues from collaborations consisted of $13 million from Kise, $3.3 million from Griffles, and $100,000 from MediSign.
Dean Schorno: $14 million in revenues from our key say collaboration increased $10 million related to an upfront fee from sublicense in Brisbane.
Dean Schorno: The $13 million in revenues from our KISAID collaboration includes $10 million related to an upfront fee from Sublicensing Resilidia and $3 million for the delivery of drug supplies.
Dean Schorno: $3 million for the delivery of drug supplies.
Dean Schorno: Moving on to cost and expenses our cost of product sales was approximately $8 million for the third quarter of 2020 for total cost and expenses were $41 $3 million compared to $32 $6 million in the same period for 2023.
Dean Schorno: Moving on to costs and expenses, our cost of product sales was approximately $8 million for the third quarter of 2024. Total costs and expenses were $41.3 million, compared to $32.6 million in the same period for 2023.
Dean Schorno: This increase in cost and expenses was primarily due to higher cost of product sales driven primarily by increased product sales of $2.3 million sub licensing revenue fee paid to form a decrease royalties and amortization of intangible assets.
Dean Schorno: The increase in cost and expenses was primarily due to higher costs of product sales, driven primarily by increased product sales, a $2.3 million sublicensing revenue fee paid to Forma, increased royalties, and amortization of intangible assets.
Dean Schorno: In addition, there was an increase in personnel related costs and commercial related expenses.
Dean Schorno: In addition, there was an increase in personnel-related costs and commercial-related expenses.
Dean Schorno: This quarter, we reported a net income of $12.4 million compared to a net loss of $5.7 million in the same period in 2023.
Dean Schorno: We reported net income of $12 $4 million compared to a net loss of $5 $7 million in the same period in 2023.
Dean Schorno: We ended the quarter with cash cash equivalents and short term investments of $61 $1 million up from $49 $1 million as of the end of the second quarter.
Dean Schorno: We ended the quarter with cash, cash equivalents, and short-term investments of 61.1 million dollars, up from 49.1 million dollars as of the end of the second quarter. We look to maintain our focused and disciplined financial approach into the future.
Dean Schorno: We maintain our focus and disciplined financial approach into the future.
Speaker Change: With that I'd like to turn the call back over to ROE ROE. Thank you D and.
Dean Schorno: With that, I'd like to turn the call back over to Raul. Raul? Thank you, Dean. And moving on to slide 30, please. This is really an exciting time for RIGEL. During the first three quarters of 24, we delivered on our goals that we set earlier in the year.
Dean Schorno: Moving on to Slide 30. Please this is really an exciting time for rigel during the first three quarters of 24th we delivered on our goals that we set earlier in the year.
Dean Schorno: First we generated strong growth in our commercial business.
Dean Schorno: First, we generated strong growth in our commercial business, we've achieved another record demand quarter for Tavalese and ResLydia, and grew our net product sales year over year.
Dean Schorno: Cheap to another record demand quarter for top at least Andrews lithium and grew our new product sales year over year.
Dean Schorno: We expanded our portfolio with the addition of Red Oak, our third commercial product, which generated $7 $1 billion in net product sales in its first full quarter with as we leveraged our commercial capabilities to transition the product to us and are now focused on maximizing its potential.
Dean Schorno: We expanded our portfolio with the addition of Gabaretto, our third commercial product, which generated $7.1 million in net product sales in its first full quarter with us. We leveraged our commercial capabilities to transition the product to us and are now focused on maximizing its potential.
Dean Schorno: And we're well on our way to deliver another record quarter of revenues for calendar year 2024.
Dean Schorno: And we're well on our way to deliver another record quarter of revenues for calendar year 2024.
Dean Schorno: Second we made significant advancements in our development pipeline.
Second, we made significant advancements in our development pipeline.
Dean Schorno: Continued to progress our two ignored and we are incredibly excited to present additional safety and efficacy data from our phase I wouldn't be starting at lower risk Mds at the Ash meeting next month.
Dean Schorno: We continue to progress R289 and we are incredibly excited to present additional safety and efficacy data from our Phase 1b study in lower risk MDS at the ASH meeting next month.
Dean Schorno: Our strategic collaboration with MD Anderson and connect continue to advance and we now have the first trial with MD Anderson underway.
Dean Schorno: Our strategic collaborations with MD Anderson and Connect continue to advance, and we now have the first trial with MD Anderson underway.
Dean Schorno: Lastly, as we made great strides in these areas, we continue to focus on maintaining financial discipline.
Dean Schorno: And lastly, as we make great strides in these areas, we continue to focus on maintaining financial discipline.
Dean Schorno: All of these efforts have enabled us to generate positive net income for the third quarters and year to date.
Speaker Change: I'm on slide 31.
Speaker Change: As we think about the future for Rogers and our progress in 'twenty, four and how it positions us to deliver continued growth in 'twenty five and beyond our corporate strategy remains focused on our major objectives.
Speaker Change: Executing and expanding our commercial portfolio to generate topline growth.
Speaker Change: Dancing in growing our development pipeline and operating in a financially disciplined manner, becoming a profitable company will allow us to be self sustaining and importantly to reinvest in our own development pipeline.
Speaker Change: And we will outline our internal development plans for our two ignored.
Speaker Change: In 2025.
Speaker Change: We've made significant progress in 'twenty four and remain focused on continuing this momentum as we close out the year and head into 2025 again I'd like to thank you for your interest in Rigel and with that we will now open the call to your questions operator.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: I would like to ask a question. Please press star one on your telephone keypad economies now indicates a question too.
Speaker Change: You May press star two to remove yourself from the queue participants using speaker equipment, it may be necessary to pick up the handset before pressing the star.
Speaker Change: Oh, please for the first question.
Speaker Change: Yeah.
Speaker Change: Our first question comes from the line of Joe.
Speaker Change: Pension Dope N genius with H C. Wainwright. Please proceed with your question.
Speaker Change: Good afternoon, and thanks for taking the questions nice to see the approved products progress. So two questions. If you don't mind. So first was hoping to see if you can provide any more color with regard to tap a lease and the balance or mix between refills and new prescriptions.
Speaker Change: Wherever you are.
Speaker Change: Some commentary on that sure. Thanks for the question, Jeff as you know our top Elisa is a product that patients taken we'll continue taking as long as their platelets are controlled and are are elevated and you know.
Speaker Change: Sometimes it takes a while so I will say that the majority of our business is carryover once we have Ah patients onboard they will tend to stay on therapy and that is the majority of our business and because we grow new patient starts are at over the last couple of years I think we're seeing a.
Speaker Change: That growth in carryover go along with that so that's what I meant to say or that's what I was referring to when I said, both our growth as opposed from new patient starting as well as carryover, but the majority is carryover Scott.
Speaker Change: Got it I appreciate that clarification and color and then the second question that I have I wanted to make sure if I heard correctly. So nice to see the early traction with Red Oak and if I heard you correctly, you said that several top centers have not have still not placed orders I was just curious is this really just based on logistics or how would you characterize.
Speaker Change: Is it.
Speaker Change: First of all when I said in my prepared comments just to be clear as I said, there's a handful a handful at top centers that we haven't seen direct orders from and and so you know we had expected to see bad and we haven't so we're we're trying to understand that a little bit but the.
The good thing about our data is we have a significant portion through the specialty pharmacy network. So we could be seeing us is patients are in the specialty pharmacy network when they transition to the ER to the rightful network versus the institution buying the drag and then how can we get there but.
Speaker Change: Overall actually what I said in my prepared remarks was that 45% of our business was through the distribution channel to direct accounts in Q3, when we just looked at this for October it's up to 50 50. So I think this is improving and we.
Speaker Change: It is more of like what we expected more of our business coming through the direct channel hope that helps Joe It certainly does thanks for the color.
Speaker Change: Thank you Joe.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Hugo North of movies with Citi. Please proceed with your question.
Speaker Change: Hi, Tim This is Arthur on for Yigal. Thanks for taking my question I. Appreciate all the updates here I just had a follow up on the last question on the.
Speaker Change: Brito sort of relaunch.
Speaker Change: Sure of a stocking benefit was there the sort of initial phase of the wash or at least with you guys.
Speaker Change: And on the on the sort of reported sales of 7 million looks like it's on at least on a similar run rate for the quarter compared to what the prior entities to deal with the last year or so how should we think about the growth trajectory from here, we should be thinking about it in a more aggressive way or or or maybe more modestly from here given the given the sort of restart.
Speaker Change: They join it takes that sure. Thanks for the question.
Speaker Change: First of all remember that at the end of Q2 right at the very end, we filled some orders to our distributors and that was what I would refer to as stocking I. It was about $1.9 billion in sales this quarter, we sold 717 bottles.
Speaker Change: And are we shipped 17 717 bottles and we had you know just a slight more than 750 odd bottles sold so they were another maybe 30. Some bottles are built up in the in the channel. So I would just say that.
Speaker Change: Geordie is demand that we saw in Q. The overwhelming majority of what we saw in Q3 is true demand patient demand account demand.
Speaker Change: And Ah what what I will say is that are you know obviously, we started the quarter with a some level of shipments going out to patients and clinics, we ended the quarter with a much higher level.
Speaker Change: Of shipments going out to patients and clinics says as you know as more people transitioned over so I.
Speaker Change: I can't really comment any more than that.
Speaker Change: But are you know we would expect to see some continued demand growth as we move forward.
Speaker Change: Translating specifically into bottle counts, we had 228 bottles of increase in our distribution channel or inventory that Dave described in Q2 and that was essentially the full amount of revenue and then we had an incremental build of that inventory of 35 bottles. The remainder of the bottles in Q3 were from.
Speaker Change: Yeah.
Speaker Change: Shipments to patients at clinics right.
Understood. Thank you very much.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question.
Speaker Change: I'm sorry.
Speaker Change: As a reminder, if you have any questions you May press star one on your telephone keypad in order to join the queue.
Speaker Change: Our next question comes from the line of counted polka with B Riley Securities. Please proceed with your question.
Speaker Change: Yeah, Hey, good afternoon, thanks for taking the question.
Speaker Change: For the proof of concept data in lower risk Mds I guess.
Speaker Change: First to the extent that you can share here.
Speaker Change: Great three or four adverse events that are listed in the abstract.
Speaker Change: Was there any indication that these were dose dependent or generally occurring in doses 500 milligrams or higher.
Speaker Change: Yeah. Thanks for the question I think some of.
Speaker Change: That will be shared in more detail in December.
Speaker Change: At the Ash meeting in the poster presentations right.
Speaker Change: Okay got it and how much more data should we expect that net of ash in terms of maybe the number of patients and the number of cohorts and things like that.
Speaker Change: So for the abstracts, we use the data cutoff date of July 16, and we're updating that to October 26, So it's gonna be about another three months or so data.
Speaker Change: And so you'll see you know data on the patients from the fourth dose level and a little bit.
Speaker Change: Okay got it thank you very much.
Kelvin: Thank you Kelvin.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of cars in a pack with Jefferies. Please proceed with your question.
Speaker Change: Hi, Good afternoon. Thank you for taking my question.
Speaker Change: To start off with the floor with the R. 29 are in the low risk Mds patients how should we think about the bar for success and what would you need to see in phase one b to advance that program forward.
Speaker Change: I went to these are common sense commentary, let me just preface this by saying that we're really excited about the state of the state are this molecule with a molecule discovered here at Rigel, we own full rights Jordan rethink.
Speaker Change: Definitely the most advanced Iraq, one and for the better that there is available.
Speaker Change: We are excited just started here in low risk Mds, where we see a very good oh mechanism to indication and we're really interested to tried here and we're delighted to present the data that you saw in the abstract and substantially.
Speaker Change: Much more detail in the poster to come in terms of the bar and lease up maybe do you want to comment on that yeah. I think that you know if we look at the treatment landscapes and lower risk Mds. Obviously, we've got you know there's kind of the first line agents patients if they're eligible for having Esa as they will have Esa is followed by a lease.
Speaker Change: Patterson is a transfusion dependent patients I'm talking about now and that'll start and there's really nothing afterwards until HMA. So that that's kind of quite a gap and in terms of efficacy H amaze, you know in terms of improving our transfusion or reducing transfusion requirements.
Speaker Change: The they have about a 20% I'm transfusion independence associated with them. So that's pretty low on one end and then our study is unique and that it's enrolling patients that have previously received H amaze as well as powder sept metal stabbed et cetera, So I'm I would say.
Speaker Change: And you know you know that the the response rates for first line, it's around 40%, but like I said.
Speaker Change: Our study is unique in that we are including relapsed refractory patients that weren't included in those first line setting. So I don't know that I would put a number on it right now I think we're very encouraged by what we're seeing based on the preliminary safety and efficacy data thus far.
Speaker Change: That's helpful and then a four cap rate, though I was just curious what the new safety signal are related to the risk of a C ran and fatal infection, how rich limiting do you expect it to be for uptake.
Speaker Change: That's right there from a competitive program have the same issue.
Speaker Change: So do you want to comment on that.
Speaker Change: I would say that from you and then maybe David can comment so from the clinical perspective, this really isn't a something new.
David: Looking at the Arrow study, we were aware that infections were reported this is in the label already and the safety section.
David: We know that Mechanistically, there's a rationale for why this is happening we know that in addition to ret inhibition that is increased risk of infections may stem from the off target inhibition of JAK, one and talk to them, which are not the primary you know targets, but nonetheless, there is somewhat of targets.
David: Activity there and we know also in terms you know most of the infections, where pneumonia is which are very common in this patient population about 80% of patients got pneumonia with lung cancer receiving treatment for lung cancer. So this is a situation that oncologists are very familiar.
David: With.
David: With managing.
Speaker Change: Did you want to comment on no what you heard from Simpson sure patient safety is Paramount and I'm very.
Speaker Change: We are proud to say that we are sent a D. H C. P to more than 10000 health care providers and that said we haven't received.
Speaker Change: Any any calls to our medical information line regarding that update and as Lisa said you know this is non small cell lung cancer. These are oncologists, who treat very sick patients. All the time you have two ret inhibitors on the market with a significant warnings and precaution.
Speaker Change: And different sets of warnings and precautions. So we don't see any at this point, we don't see any.
Speaker Change: You know.
Speaker Change: Changes in how we look at the opportunity for.
Speaker Change: For gift Red Oak moving forward in Iraq.
Speaker Change: Fusion positive non small cell lung cancer space.
Speaker Change:
Speaker Change: That's helpful. Thank you so much.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: Our next question again comes from copies per ton with B Riley security.
Speaker Change: Proceed with your question.
Speaker Change: Yeah. Thanks for taking the follow up I just had one more on the lower risk Mds program.
Speaker Change: There was another agent curious as Iraq inhibitor that was started in an investigator sponsored study, but then later withdrawn for the same indication.
Speaker Change: So I guess, if you do highlight if you differentiated factor.
Speaker Change: Alright.
Speaker Change: Versus the others what would they be.
Speaker Change: I you know its hard to comment on other People's I would say ours is on Iraq. One in four inhibitor I believe theres was in Iraq for in your bedroom that isn't a significant difference I think Lisa highlighted in one of the slides, where we show that are inhibiting both one in four provides a more profound inhibition of inflammatory cytokines.
Speaker Change: Cards, presumably in the bone marrow in this case, so that is an important difference between those those two and as I said earlier.
Speaker Change: I don't believe there's another Iraq, one and four inhibitor in development I'm certainly not at more advanced development are available. So we this is the first to work on our one four and that restaurant all the more profound cytokine inhibition was one of the reasons. We liked one in for over four and we start any other comments.
Speaker Change: I think that's fairly pretty well summarized.
Speaker Change: Okay wonderful thank you again.
Speaker Change: Thank you Kelvin.
Speaker Change: Thank you there are no further questions at this time I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.
Speaker Change: Thank you and thank you everyone for joining on the call today and your continued interest interest in Rigel I can't say, it's a very exciting time for the company having data to share on an exciting product and more coming I think is a really a great place to be a year has gone very well for us in terms of commercial growth addition, too.
Speaker Change: Portfolio and advancements in our development and we look forward to telling you more about that in the in the 2025, so with that I'd like to also just always thank our employees for their continued commitment to our cause and improving the lives of patients and look forward to updating you further in other calls.
Speaker Change:
Speaker Change: And this concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
Speaker Change: Yeah.
Speaker Change: Oh, yes.
Speaker Change: So it doesn't.
Speaker Change: Okay.