Company Performance - Rigel Pharmaceuticals reported quarterly earnings of $0.70 per share, significantly exceeding the Zacks Consensus Estimate of $0.01 per share, compared to a loss of $0.30 per share a year ago, representing an earnings surprise of 6,900% [1] - The company posted revenues of $55.31 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 35.92%, and showing an increase from $28.13 million in the same quarter last year [2] - Over the last four quarters, Rigel has surpassed consensus EPS estimates three times and has topped consensus revenue estimates three times as well [2] Market Performance - Rigel shares have increased approximately 4% since the beginning of the year, while the S&P 500 has gained 24.3% [3] - The current consensus EPS estimate for the upcoming quarter is $0.06 on revenues of $45.95 million, and for the current fiscal year, it is -$0.72 on revenues of $151.6 million [7] Industry Outlook - The Medical - Drugs industry, to which Rigel belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Rigel's stock performance [5][6]

[Q3 2024 Financial & Business Highlights](index=1&type=section&id=Q3%202024%20Financial%20%26%20Business%20Highlights) Rigel reported strong Q3 2024 results with **$55.3 million** total revenue, achieving profitability and advancing key commercial and clinical initiatives including a REZLIDHIA licensing deal Q3 2024 Revenue Breakdown | Metric | Amount | | :--- | :--- | | **Total Revenue** | **$55.3 million** | | TAVALISSE Net Product Sales | $26.3 million | | REZLIDHIA Net Product Sales | $5.5 million | | GAVRETO Net Product Sales | $7.1 million | - Entered into an agreement with Kissei to develop and commercialize REZLIDHIA in Japan, the Republic of Korea, and Taiwan, receiving a **$10.0 million** upfront cash payment[1](index=1&type=chunk)[4](index=4&type=chunk) - Initial data from the Phase 1b study of R289, a dual IRAK1/4 inhibitor, in lower-risk myelodysplastic syndrome (LR-MDS) will be presented at the 66th ASH Annual Meeting[1](index=1&type=chunk) - The company's focus on financial discipline resulted in a positive third-quarter and year-to-date net income[2](index=2&type=chunk) [Business Update](index=1&type=section&id=Business%20Update) Rigel's business update highlights continued commercial momentum, successful GAVRETO integration, a key REZLIDHIA licensing deal, and clinical advancements for R289 and REZLIDHIA combination therapy [Commercial Update](index=1&type=section&id=Commercial%20Update) Rigel's commercial portfolio showed continued strength with record bottle shipments, successful GAVRETO patient transition, and a significant REZLIDHIA licensing agreement with Kissei Product Bottle Shipments | Product | Bottles Shipped to Patients/Clinics | Change in Distribution Channel | Total Bottles Shipped | | :--- | :--- | :--- | :--- | | **TAVALISSE** | 2,797 | (4) | 2,793 | | **REZLIDHIA** | 444 | (15) | 429 | | **GAVRETO** | 717 | 35 | 752 | - Entered an exclusive license agreement with Kissei for REZLIDHIA in Japan, South Korea, and Taiwan, receiving a **$10.0 million** upfront payment with potential for up to an additional **$152.5 million** in milestones[4](index=4&type=chunk) - Successfully transitioned existing GAVRETO patients to Rigel's product following its commercial launch in June 2024. A Dear Health Care Provider (DHCP) letter was issued in October regarding a new safety signal for GAVRETO[3](index=3&type=chunk)[5](index=5&type=chunk) [Clinical and Development Update](index=2&type=section&id=Clinical%20and%20Development%20Update) Rigel is advancing its clinical pipeline, highlighted by the ongoing Phase 1b study of R289 in LR-MDS with positive initial data and the initiation of a REZLIDHIA combination therapy trial - Initial data from the Phase 1b study of R289 in R/R LR-MDS showed the drug was well-tolerated. RBC-transfusion independence (RBC-TI) or hematologic improvement (HI-E) occurred in **36%** of patients receiving doses ≥500 mg QD[7](index=7&type=chunk) - Enrollment is underway in the fifth dose level (500mg / 250mg split dose) of the R289 Phase 1b study[6](index=6&type=chunk) - The first patient was enrolled in a Phase 1b/2 triplet therapy trial of REZLIDHIA in combination with decitabine and venetoclax, sponsored by MD Anderson Cancer Center[6](index=6&type=chunk) [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) Rigel demonstrated a significant financial turnaround, achieving profitability in Q3 and year-to-date 2024, driven by robust revenue growth from product sales and contract revenue, alongside improved cash position [Third Quarter 2024 Financial Results](index=2&type=section&id=Third%20Quarter%202024%20Financial%20Results) Rigel's Q3 2024 total revenues surged to **$55.3 million** from **$28.1 million** in Q3 2023, driven by product sales and contract revenues, resulting in a net income of **$12.4 million** or **$0.70** diluted EPS Q3 2024 Financial Summary | Financial Metric (in millions, except EPS) | Q3 2024 | Q3 2023 | YoY Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$55.3** | **$28.1** | **+96.6%** | | TAVALISSE Net Sales | $26.3 | $24.5 | +7.3% | | REZLIDHIA Net Sales | $5.5 | $2.7 | +103.7% | | GAVRETO Net Sales | $7.1 | N/A | N/A | | Contract Revenue | $16.4 | $1.0 | +1540% | | Total Costs & Expenses | $41.3 | $32.6 | +26.7% | | **Net Income (Loss)** | **$12.4** | **($5.7)** | **Turned to Profit** | | **Diluted EPS** | **$0.70** | **($0.33)** | **Turned to Profit** | - The increase in costs and expenses was mainly due to higher cost of product sales, a sublicensing fee to Forma, increased royalties, amortization of intangible assets, and higher personnel and commercial-related expenses[8](index=8&type=chunk) [Year-to-Date (Nine Months) 2024 Financial Results](index=3&type=section&id=Year-to-Date%20(Nine%20Months)%202024%20Financial%20Results) For the nine months ended September 30, 2024, total revenues reached **$121.7 million**, a **50%** increase, resulting in a net income of **$3.1 million** or **$0.18** diluted EPS, reversing prior-year losses Year-to-Date Financial Summary | Financial Metric (in millions, except EPS) | YTD 2024 | YTD 2023 | YoY Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$121.7** | **$81.1** | **+50.1%** | | TAVALISSE Net Sales | $73.8 | $68.1 | +8.4% | | REZLIDHIA Net Sales | $15.6 | $6.7 | +132.8% | | GAVRETO Net Sales | $9.0 | N/A | N/A | | Contract Revenue | $23.3 | $5.3 | +339.6% | | Total Costs & Expenses | $114.1 | $103.5 | +10.2% | | **Net Income (Loss)** | **$3.1** | **($25.8)** | **Turned to Profit** | | **Diluted EPS** | **$0.18** | **($1.49)** | **Turned to Profit** | - The increase in year-to-date costs was driven by higher cost of product sales and commercial expenses, partially offset by decreased R&D costs due to the timing of clinical trial activities[11](index=11&type=chunk) [Balance Sheet and Cash Position](index=3&type=section&id=Balance%20Sheet%20and%20Cash%20Position) As of September 30, 2024, Rigel's cash, cash equivalents, and short-term investments increased to **$61.1 million**, with total assets growing to **$139.4 million** Balance Sheet Summary | Balance Sheet Item (in millions) | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents & short-term investments | $61.1 | $56.9 | | Total Assets | $139.4 | $117.2 | | Stockholders' Deficit | ($14.6) | ($28.6) | [Company and Product Portfolio Overview](index=4&type=section&id=Company%20and%20Product%20Portfolio%20Overview) Rigel Pharmaceuticals is a biotechnology company focused on hematologic disorders and cancer, with a commercial portfolio including TAVALISSE, REZLIDHIA, and GAVRETO for various indications [Marketed Products](index=4&type=section&id=Marketed%20Products) Rigel markets three key products: TAVALISSE for chronic ITP, REZLIDHIA for relapsed or refractory AML with IDH1 mutation, and GAVRETO for metastatic RET fusion-positive NSCLC and thyroid cancer - **TAVALISSE (fostamatinib):** Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment[20](index=20&type=chunk) - **REZLIDHIA (olutasidenib):** Indicated for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation[21](index=21&type=chunk) - **GAVRETO (pralsetinib):** Indicated for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and for adult and pediatric patients (12+) with advanced or metastatic RET fusion-positive thyroid cancer[22](index=22&type=chunk) [Target Diseases](index=4&type=section&id=Target%20Diseases) Rigel's therapeutic focus addresses significant unmet needs in Immune Thrombocytopenia (ITP), Acute Myeloid Leukemia (AML), and Non-Small Cell Lung Cancer (NSCLC) - **Immune Thrombocytopenia (ITP):** An autoimmune disorder where the body attacks its own platelets, leading to excessive bruising and bleeding[16](index=16&type=chunk) - **Acute Myeloid Leukemia (AML):** A rapidly progressing cancer of the blood and bone marrow, primarily affecting adults. Relapsed or refractory AML presents a significant treatment challenge[17](index=17&type=chunk)[18](index=18&type=chunk) - **Non-Small Cell Lung Cancer (NSCLC):** The most common type of lung cancer, accounting for **80-85%** of all diagnoses. RET fusions are implicated in approximately **1-2%** of NSCLC cases[19](index=19&type=chunk)

Revenue Performance - For the nine months ended September 30, 2024, net product sales of TAVALISSE were $73.8 million, an increase of $5.7 million or 8% compared to $68.1 million in the same period in 2023[122]. - For the nine months ended September 30, 2024, net product sales of REZLIDHIA were $15.6 million, an increase of $8.9 million or 133% compared to $6.7 million in the same period in 2023[123]. - GAVRETO recognized $9.0 million in net product sales for the nine months ended September 30, 2024, following its commercialization beginning June 27, 2024[124]. - Product sales for the three months ended September 30, 2024, were $38.9 million, an increase of 43% compared to $27.1 million for the same period in 2023[190]. - Total revenues for the three months ended September 30, 2024, reached $55.3 million, up from $28.1 million in the same period in 2023, marking an increase of $27.2 million[190]. - TAVALISSE net product sales for the three months ended September 30, 2024, were $26.3 million, an 8% increase from $24.5 million in the same period in 2023[192]. - REZLIDHIA net product sales for the three months ended September 30, 2024, were $5.5 million, a 107% increase compared to $2.7 million in the same period in 2023[192]. - GAVRETO net product sales recognized for the three months ended September 30, 2024, were $7.1 million, following its commercialization in June 2024[192]. Collaborations and Agreements - The acquisition of GAVRETO included a purchase price of $15.0 million, with $10.0 million paid upon the first commercial sale and an additional $5.0 million payable on the first anniversary of the agreement[124]. - The strategic collaboration with MDACC includes $15.0 million in milestone payments over five years for the evaluation of olutasidenib in AML and other hematologic cancers[130]. - The collaboration with CONNECT involves a Phase 2 clinical trial for olutasidenib in combination with temozolomide, with funding up to $3.0 million over four years[131]. - The expansion of the relationship with Kissei includes a one-time upfront cash payment of $10.0 million and potential additional payments of up to $152.5 million in milestones[132]. - The company in-licensed olutasidenib from Forma with exclusive worldwide rights for development, manufacturing, and commercialization, with Forma entitled to a portion of sublicensing revenue, including $2.3 million upon receipt of a $10.0 million upfront payment expected in Q4 2024[133][134]. - The company entered a collaboration and license agreement with Kissei for the development and commercialization of olutasidenib in Japan, Korea, and Taiwan in September 2024[169]. Clinical Development - The company is advancing the R289 dual IRAK 1/4 inhibitor program in a Phase 1b study for patients with lower-risk MDS, with an expected enrollment of approximately 40 patients[127]. - As of July 15, 2024, 4 out of 11 patients receiving R289 doses ≥500 mg/daily achieved transfusion independence or hematologic improvement responses[129]. - Lilly is advancing ocadusertib, a selective RIPK1 inhibitor, with a Phase 2a trial involving approximately 100 patients for rheumatoid arthritis, with preliminary results expected in H1 2025[136]. - Under the Lilly Agreement, the company is responsible for 20% of development costs for ocadusertib in the US, Europe, and Japan, with a funding commitment capped at a specified amount through April 1, 2024, totaling $21.4 million provided to Lilly[137]. - The Phase 2 trial of olutasidenib showed a complete remission (CR) plus CR with partial hematologic recovery (CRh) rate of 33.3% and an overall response rate (ORR) of 46%[159]. - An updated interim analysis indicated a 35% CR+CRh rate with a median duration of 25.9 months in the registrational cohort of the Phase 2 trial[161]. - The strategic collaboration with MDACC aims to evaluate olutasidenib in AML and other hematologic cancers, with the first patient enrolled in a Phase 1b/2 trial in September 2024[180]. Financial Performance - The company has exclusive commercialization agreements for fostamatinib in various regions, including a license agreement with Grifols for the EU and UK, and a partnership with Kissei for Japan, China, Taiwan, and Korea[151][152]. - The company received a $10.0 million upfront payment from Kissei as part of a collaboration and license agreement during the nine months ended September 30, 2024[222]. - Future contingent payments under existing collaboration agreements could exceed $1.4 billion if all potential product candidates achieve specified payment triggering events[227]. - The company has a credit agreement with MidCap providing a $60.0 million term loan credit facility, fully funded as of September 30, 2024[229]. - The company expects to continue to generate cash from operating activities to support its commercialization efforts for at least the next 12 months[225]. - As of September 30, 2024, the company had approximately $61.1 million in cash, cash equivalents, and short-term investments, up from $56.9 million as of December 31, 2023[221]. - Net cash provided by operating activities for the nine months ended September 30, 2024 was $16.968 million, significantly higher than $497,000 for the same period in 2023[222]. Expenses and Costs - Cost of product sales for the three months ended September 30, 2024, was $8,026,000, an increase of $6,758,000 compared to $1,268,000 for the same period in 2023[196]. - Research and development expense for the three months ended September 30, 2024, was $6,182,000, a decrease of $293,000 from $6,475,000 in the same period in 2023[198]. - Selling, general and administrative expense for the three months ended September 30, 2024, was $27,043,000, an increase of $2,187,000 compared to $24,856,000 for the same period in 2023[211]. - The increase in cost of product sales was primarily due to increased royalty expense and sublicensing revenue fees of $3.4 million and $4.5 million, respectively[197]. - Research and development expenses related to ongoing clinical development programs for olutasidenib increased by approximately $2.0 million[202]. - The company expects to incur significant selling, general and administrative expenses as it expands commercial activities for TAVALISSE, REZLIDHIA, and GAVRETO[214]. - The decrease in research and development expense in the nine months ended September 30, 2024, was partly due to decreased clinical trial related expenses of $2.8 million[200]. Regulatory and Market Considerations - The FDA granted orphan drug designation for fostamatinib in August 2015, and it was approved in April 2018 for adult patients with chronic ITP who had insufficient response to previous treatments[144]. - REZLIDHIA was added to the NCCN Clinical Practice Guidelines for AML as a recommended targeted therapy in January 2023[162]. - GAVRETO received new chemical entity exclusivity until September 2025 and orphan drug exclusivity until September 2027 for specific indications[174]. - GAVRETO faces competition from Lilly's selpercatinib and other therapies for RET fusion-positive NSCLC and advanced thyroid cancers[175]. - The company is subject to claims related to patent protection and securities class action lawsuits, requiring careful assessment of potential losses[240]. - There were no material changes to the company's market risk disclosures during the nine months ended September 30, 2024[241].

Core Insights - Rigel Pharmaceuticals reported a total revenue of $55.3 million for the third quarter of 2024, with significant contributions from TAVALISSE, REZLIDHIA, and GAVRETO product sales [2][4][9] - The company entered into a licensing agreement with Kissei Pharmaceutical for REZLIDHIA, receiving an upfront payment of $10 million and potential milestone payments totaling $152.5 million [3][4] - Rigel's net income for the third quarter was $12.4 million, a significant improvement compared to a net loss of $5.7 million in the same period of 2023 [4][9] Commercial Update - Rigel achieved record shipments of bottles for all products, with TAVALISSE, REZLIDHIA, and GAVRETO showing strong commercial performance [3][4] - GAVRETO became commercially available in June 2024, and the third-quarter results reflect a successful transition of existing patients to Rigel's product [3][4] - The company is focusing on transitioning patients for GAVRETO in the fourth quarter [3] Clinical and Development Update - Rigel is advancing its Phase 1b clinical study of R289, a dual IRAK1/4 inhibitor, in patients with lower-risk myelodysplastic syndrome [4] - Initial data from the R289 study indicate that 36% of evaluable patients achieved RBC-transfusion independence or hematologic improvement [4] - Rigel announced the enrollment of the first patient in a Phase 1b/2 trial of REZLIDHIA in combination with decitabine and venetoclax for patients with mIDH1 AML [4] Financial Performance - Total revenues for the third quarter included $26.3 million from TAVALISSE, $5.5 million from REZLIDHIA, and $7.1 million from GAVRETO, with contract revenue from collaborations amounting to $16.4 million [4][9] - TAVALISSE net product sales grew by 8% year-over-year, while REZLIDHIA sales increased by 107% [4][9] - Total costs and expenses for the third quarter were $41.3 million, up from $32.6 million in the same period of 2023, primarily due to increased product sales costs [4][9] Balance Sheet Highlights - As of September 30, 2024, Rigel had cash, cash equivalents, and short-term investments of $61.1 million, an increase from $49.1 million as of June 30, 2024 [6][10] - Total assets were reported at $139.4 million, with a stockholders' deficit of $14.6 million [10]

Core Insights - Rigel Pharmaceuticals is set to present data from its hematology-oncology portfolio at the 66th American Society of Hematology (ASH) Annual Meeting from December 7-10, 2024, in San Diego, California [1][2] Group 1: R289 Study - Initial data from the Phase 1b study of R289, a dual IRAK1/4 inhibitor, shows it was well tolerated in heavily pretreated patients with lower-risk myelodysplastic syndrome (LR-MDS), with a median of 4 prior therapies [3][4] - Among 14 evaluable patients, 36% achieved RBC-transfusion independence or hematologic improvement with a median duration of 29 weeks [3][4] Group 2: Olutasidenib Data - Data on olutasidenib for relapsed/refractory mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML) indicates that some patients respond quickly within 1-2 months, while others may take up to 10 months for overall response [3][4] - A combination of olutasidenib and azacitidine achieved a complete remission or complete remission with partial hematologic recovery in 31% of patients, with a median duration of 15 months [4][5] - In a study comparing olutasidenib to ivosidenib, olutasidenib showed favorable effectiveness in patients with mIDH1 AML who were relapsed or refractory to a venetoclax-based regimen [6] Group 3: TAVALISSE Data - TAVALISSE (fostamatinib) is indicated for chronic immune thrombocytopenia (ITP) and has shown clinically meaningful responses in combination with thrombopoietin receptor agonists [7][8] - The safety profile of TAVALISSE includes monitoring for hypertension and elevated liver function tests, with diarrhea occurring in 31% of patients [7][8]

Core Points - Rigel Pharmaceuticals, Inc. will report its third quarter 2024 financial results after market close on November 7, 2024 [1] - A live conference call and webcast will follow the announcement at 4:30 p.m. Eastern Time [1] - The company focuses on developing therapies for hematologic disorders and cancer [3] Company Information - Rigel Pharmaceuticals was founded in 1996 and is based in South San Francisco, California [3] - The company is dedicated to discovering and providing novel therapies to improve patient lives [3] - More information about Rigel's marketed products and pipeline can be found on their website [3]

SOUTH SAN FRANCISCO, Calif., Oct. 24, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. ("Rigel") (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced it is issuing a Dear Health Care Provider (DHCP) letter related to a new safety signal for GAVRETO® (pralsetinib) after consultation with the U.S. Food and Drug Administration (FDA). GAVRETO is for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positiv ...

ST. LOUIS, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Optime Care, a nationally recognized specialty pharmacy and an AscellaHealth Company, today announces an expanded arrangement with Rigel Pharmaceuticals, Inc, effective October 14, 2024, to include commercial distribution of TAVALISSE® (fostamatinib). TAVALISSE is an oral medicine that can help patients manage chronic immune thrombocytopenia (ITP) by protecting their platelets from destruction. "Under this expanded agreement, Optime Care will now manage commercia ...

Join Compounding Healthcare where we employ data analytics in combination with technical analysis and clinical data breakdown in order to manage a position in numerous potential multi-bagger investments that can grow into a comprehensive healthcare portfolio. It has been roughly seven months since my last Rigel Pharmaceuticals (NASDAQ: RIGL ) article , where I discussed their strategic acquisition of GAVRETO (pralsetinib), which, I thought, had a competitive edge over Eli Lilly's ( LLY ) Retevmo. Since then ...

Company Overview - Rigel Pharmaceuticals (RIGL) shares increased by 19.7% to $16.35 in the last trading session, with a higher-than-average trading volume [1] - The stock has shown a 1.6% gain over the past four weeks [1] Recent Developments - The company recently enrolled the first patient in a phase Ib/II triplet therapy study for its drug Rezlidhia (olutasidenib), in combination with decitabine and venetoclax, targeting mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML) [2] Financial Expectations - Rigel is expected to report quarterly earnings of $0.01 per share, reflecting a year-over-year increase of 103.3% [3] - Revenue projections stand at $40.69 million, which is a 44.7% increase compared to the same quarter last year [3] - The consensus EPS estimate has remained unchanged over the last 30 days, indicating a potential stability in earnings expectations [4] Industry Context - Rigel is part of the Zacks Medical - Drugs industry, where another company, Indivior PLC (INDV), saw a 0.5% increase to $9.32 but has a negative return of -25.5% over the past month [4] - Indivior's consensus EPS estimate for the upcoming report is $0.44, representing a year-over-year change of 29.4% [5]