Shares of Rigel Pharmaceuticals (RIGL) have gained 53.5% over the past four weeks to close the last trading session at $22.74, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $29.17 indicates a potential upside of 28.3%.The mean estimate comprises six short-term price targets with a standard deviation of $18.89. While the lowest estimate of $14 indicates a 38.4% decline from the ...

Company Overview - Rigel Pharmaceuticals, Inc. is a commercial stage biotechnology company focused on hematologic disorders and cancer [1][3] - The company was founded in 1996 and is based in South San Francisco, California [3] Upcoming Event - Dean Schorno, the chief financial officer of Rigel, will present a company overview at the Jefferies London Healthcare Conference on November 19, 2024, at 9:30 am GMT (4:30 am EST) [1] Investor Relations - Investors can access the live webcast or archived recording of the presentation through the Investor Relations section of Rigel's website [2]

Financial Data and Key Metrics Changes - In Q3 2024, Rigel Pharmaceuticals reported total net sales of $38.9 million, representing a 44% increase compared to Q3 2023 [9][52] - The company achieved a net income of $12.4 million in Q3 2024, compared to a net loss of $5.7 million in the same period in 2023 [58] - Cash, cash equivalents, and short-term investments increased to $61.1 million from $49.1 million [58] Business Line Data and Key Metrics Changes - TAVALISSE generated $26.3 million in net product sales in Q3 2024, an 8% increase from $24.5 million in Q3 2023 [52] - REZLIDHIA achieved net product sales of $5.5 million in Q3 2024, a 107% increase compared to $2.7 million in Q3 2023 [52] - GAVRETO, in its first full quarter, generated $7.1 million in net product sales [52] Market Data and Key Metrics Changes - Rigel expanded its product presence outside the US with a new agreement with Kissei to develop and commercialize REZLIDHIA in Japan, Korea, and Taiwan, including a $10 million upfront payment [10] - The company shipped 2,793 bottles of TAVALISSE, 444 bottles of REZLIDHIA, and 752 bottles of GAVRETO in Q3 2024 [50][51] Company Strategy and Development Direction - Rigel's corporate strategy focuses on expanding its commercial portfolio, advancing its pipeline through collaborations and internal development, and maintaining financial discipline [8][63] - The company aims to become self-sustaining and reinvest in its development pipeline, with plans to discuss development plans for R289 and olutasidenib in 2025 [63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's growth trajectory, highlighting strong commercial execution and the successful transition of GAVRETO into Rigel's portfolio [14][60] - The company is well-positioned to continue driving value as it heads into 2025, with expectations for continued revenue growth [15][63] Other Important Information - Rigel is advancing the development of R289, a dual IRAK1/4 inhibitor, in a Phase 1b study for lower-risk MDS, with initial safety and efficacy data to be presented at the ASH meeting [11][32] - The company is exploring opportunities to in-license or acquire late-stage hematology and oncology assets to further expand its portfolio [13][35] Q&A Session Summary Question: Can you provide more color on TAVALISSE regarding the balance between refills and new prescriptions? - Management indicated that the majority of TAVALISSE's business comes from carryover, with growth from both new patient starts and existing patients [67][68] Question: What is the status of GAVRETO orders from top centers? - Management noted that a handful of top centers have not placed orders yet, but overall business through specialty pharmacies is improving [70][71] Question: How much of a stocking benefit was there during the initial phase of GAVRETO's launch? - Management clarified that the majority of Q3 sales were true demand, with some initial stocking contributing to sales figures [75][76] Question: What is the bar for success for R289 in lower-risk MDS? - Management expressed excitement about the data and indicated that the study is unique in enrolling relapsed/refractory patients, which could differentiate it from existing treatments [82][84] Question: How does Rigel's R289 compare to other IRAK inhibitors? - Management highlighted that R289 is a dual IRAK1 and 4 inhibitor, which may provide more profound inhibition of inflammatory cytokines compared to other single-target inhibitors [90]

Rigel Pharmaceuticals (RIGL) came out with quarterly earnings of $0.70 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to loss of $0.30 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 6,900%. A quarter ago, it was expected that this drug developer would post a loss of $0.37 per share when it actually produced a loss of $0.06, delivering a surprise of 83.78%.Over the last four quarters, the com ...

Exhibit 99.1 Rigel Reports Third Quarter 2024 Financial Results and Provides Business Update · Third quarter total revenue of $55.3 million, which includes TAVALISSE net product sales of $26.3 million, REZLIDHIA net product sales of $5.5 million and GAVRETO net product sales of $7.1 million · Entered into an agreement with Kissei to develop and commercialize REZLIDHIA in all potential indications in Japan, the Republic of Korea and Taiwan, recording an upfront cash payment of $10.0 million during the third ...

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]

-    Initial data from the ongoing Phase 1b study evaluating R289, a dual IRAK1/4 inhibitor, in LR-MDS-    Additional data for REZLIDHIA® (olutasidenib) in patients with mIDH1 AML and MDSSOUTH SAN FRANCISCO, Calif., Nov. 5, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced upcoming presentations of six posters highlighting data from their commercial and clinical-stage hematology-oncology port ...

SOUTH SAN FRANCISCO, Calif., Oct. 31, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will report its third quarter 2024 financial results after market close on Thursday, November 7, 2024. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.Participants can access the live conference call by dialing 877-407-308 ...

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 ...