Core Insights - Rigel Pharmaceuticals has reached a settlement agreement with Annora Pharma and its affiliates regarding patent litigation over TAVALISSE, allowing Annora to potentially market a generic version by Q2 2032 or earlier under certain conditions [1][2] - The settlement highlights the strength of Rigel's intellectual property related to TAVALISSE, which is an innovative treatment for immune thrombocytopenia (ITP) [2] - Rigel remains focused on advancing its portfolio of therapies aimed at improving the lives of patients with hematological disorders and cancer [2][6] Company Overview - Rigel Pharmaceuticals, Inc. is a biotechnology company founded in 1996, based in South San Francisco, California, dedicated to developing novel therapies for hematologic disorders and cancer [6] - TAVALISSE (fostamatinib disodium hexahydrate) is indicated for treating thrombocytopenia in adult patients with chronic ITP who have not responded adequately to previous treatments [4] Industry Context - Immune thrombocytopenia (ITP) is a condition where the immune system attacks and destroys the body's blood platelets, leading to symptoms such as excessive bruising and bleeding [3] - Current treatment options for ITP include steroids, platelet production boosters, and splenectomy, but there is a significant medical need for additional therapies as not all patients respond to existing treatments [3]

Core Insights - Rigel Pharmaceuticals has appointed Dr. Mark W. Frohlich to its Board of Directors, bringing over 25 years of experience in developing cellular immunotherapies for cancer treatment [1][2] - Dr. Frohlich's expertise includes clinical drug development, translational research, and portfolio strategy, which will support Rigel's hematology and oncology development pipeline [2][4] - He has previously held significant roles in various biotechnology companies, including as CEO of Indapta Therapeutics and leading portfolio strategy at Juno Therapeutics [2][3] Company Overview - Rigel Pharmaceuticals, Inc. is a biotechnology company focused on discovering and developing novel therapies for hematologic disorders and cancer [4] - The company was founded in 1996 and is based in South San Francisco, California [4] - Rigel aims to improve the lives of patients through its marketed products and pipeline of potential products [4]

Shares of Rigel Pharmaceuticals (RIGL) have gained 5.9% over the past four weeks to close the last trading session at $22.08, 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 $32 indicates a potential upside of 44.9%.The average comprises six short-term price targets ranging from a low of $20 to a high of $57, with a standard deviation of $16.52. While the lowest estimate indicat ...

Financial Data and Key Metrics Changes - Rigel Pharmaceuticals reported record sales of $145 million for 2024, representing a 39% increase compared to 2023 [10][20] - The company achieved a net income of $17 million for the full year, a significant turnaround from a net loss of $25.1 million in 2023 [75] - Cash and short-term investments increased to $77.3 million from $56.9 million at the end of 2023 [75] Business Line Data and Key Metrics Changes - TAVALISSE sales reached $31 million in Q4 2024, a 21% increase year-over-year, while Rezlidia sales nearly doubled to $7.4 million [68] - Gavreto generated $8.1 million in net product sales in its second full quarter, exceeding the previous annual run rate of $28 million [23][68] - The company reported a compound annual growth rate of 32% in net product sales from 2021 to 2024 [16] Market Data and Key Metrics Changes - TAVALISSE is now commercially available in multiple countries, including Japan, Europe, Canada, and Israel, with recent approvals in Mexico and Korea [10][30] - The company is actively pursuing regulatory approvals for Rezlidia in ex-US markets, expanding its partnerships in Asia [30][31] Company Strategy and Development Direction - Rigel's strategy focuses on expanding its commercial portfolio, advancing its pipeline through internal development and collaborations, and maintaining financial discipline [8] - The company aims to grow its hematology and oncology business while achieving profitability and cash flow breakeven [79] - Plans for 2025 include advancing the R289 program for lower-risk MDS and initiating a Phase 2 study for olutasidenib in recurrent glioma [80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in net product sales, projecting a 30% year-over-year increase for 2025 [79] - The company highlighted the importance of maintaining high-quality access while reducing distribution costs to improve gross-to-net adjustments [70] Other Important Information - Rigel's R289 program has received both fast track and orphan drug designations from the FDA, indicating a strong regulatory interest [40] - The company is exploring opportunities to in-license or acquire products that align with its hematology and oncology focus [36] Q&A Session Summary Question: Can you provide more color on the product guidance for 2025? - Management clarified that the guidance of $185 to $192 million reflects normalization after a Q4 inventory build, with a projected 30% year-over-year growth in net product sales [85][86] Question: What data do you have on the duration of therapy for Rezlidia? - Management refrained from sharing specific data but indicated optimism about growth as awareness increases and more patients are treated earlier in their therapy [88][89] Question: How did TAVALISSE sales increase in Q4? - Management confirmed that the increase was driven by volume rather than price, with the highest quarterly demand ever recorded [101][102] Question: What is the strategy for the glioma program? - Management stated that it is too early to comment on the study design but plans to provide more information later in the year [106][108] Question: How is the sales force structured for future growth? - Management emphasized the importance of synergies across teams and the need to assess market impact when considering sales force expansion [120][123]

Group 1 - Rigel Pharmaceuticals reported quarterly earnings of $0.80 per share, exceeding the Zacks Consensus Estimate of $0.55 per share, and compared to break-even earnings per share a year ago, representing an earnings surprise of 45.45% [1] - The company posted revenues of $57.6 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 0.02%, and this is an increase from year-ago revenues of $35.79 million [2] - Rigel shares have increased approximately 33% since the beginning of the year, while the S&P 500 has declined by 0.5% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is $0.31 on revenues of $44.8 million, and for the current fiscal year, it is $1.28 on revenues of $201.14 million [7] - The Zacks Industry Rank indicates that the Medical - Drugs sector is currently in the bottom 46% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [8] Group 3 - The estimate revisions trend for Rigel is favorable, leading to a Zacks Rank 1 (Strong Buy) for the stock, indicating expected outperformance in the near future [6] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - Preliminary total revenue for Q4 2024 is approximately $57.6 million, up from $35.8 million in Q4 2023, representing a 60% increase[6] - Net product sales for Q4 2024 are expected to be $46.5 million, compared to $29.5 million for the same period in 2023, marking a 57% increase[6] - TAVALISSE net product sales reached $31.0 million in Q4 2024, an increase from $25.7 million in Q4 2023, reflecting a 21% growth[6] - Rigel anticipates total revenue for 2025 to be between $200 million and $210 million, with expectations of positive net income for the year[12] - TAVALISSE surpassed $100 million in net product sales for the full year 2024, reporting $104.8 million[10] - Contract revenues from collaborations for Q4 2024 are expected to be approximately $11.1 million, including a $4.0 million upfront payment from Dr. Reddy's Laboratories[10] - Rigel expects to report cash, cash equivalents, and short-term investments of approximately $77.3 million as of December 31, 2024, compared to $56.9 million at the end of 2023[10] Clinical Development - The Phase 1b study of R289 in lower-risk MDS continues to enroll patients, with promising initial safety and efficacy data published[3] - Rigel plans to initiate a Phase 2 clinical study in recurrent glioma in 2025[12] - The study of R289 in lower-risk MDS will provide safety and efficacy data[23] Strategic Partnerships - Rigel entered into an exclusive license agreement with Dr. Reddy's for REZLIDHIA, with potential future milestone payments of up to $36.0 million[10] - The company is focused on enhancing its partnering and collaboration efforts[23] Future Outlook - The company anticipates expected commercial and financial results for Q4 2024 and the year ended December 31, 2024[23] - Projected financial performance and outlook for 2025 includes growth in the commercial portfolio and hematology and oncology pipeline[23] Risks and Challenges - Risks associated with the commercialization and marketing of fostamatinib, olutasidenib, and pralsetinib are acknowledged[23] - Potential adverse decisions from regulatory authorities regarding fostamatinib, pralsetinib, or olutasidenib are highlighted as risks[23] - Clinical trials may not predict real-world results, which poses a risk to future performance[23] - The company does not undertake any obligation to update forward-looking statements unless required by law[23]

Revenue and Sales Performance - Total revenues for 2024 were $179.3 million, an increase of 53.4% compared to $116.9 million in 2023[580]. - Net product sales of TAVALISSE reached $104.8 million in 2024, a 12% increase from $93.7 million in 2023[582]. - REZLIDHIA net product sales surged by 118% to $23.0 million in 2024, up from $10.6 million in 2023[582]. - GAVRETO generated $17.1 million in net product sales following its commercialization in June 2024[582]. - Contract revenues from collaborations totaled $34.4 million in 2024, a significant increase of 199.5% from $11.5 million in 2023[583]. - Product sales, net, increased to $144.902 million in 2024, up 38.9% from $104.294 million in 2023[655]. - The company reported gross product sales of $209.9 million for 2024, an increase from $147.1 million in 2023[737]. - McKesson Corporation accounted for 45% of total net product sales in 2024, up from 43% in 2023[738]. Financial Position and Cash Flow - As of December 31, 2024, the company had approximately $77.3 million in cash, cash equivalents, and short-term investments, an increase from $56.9 million in 2023[606]. - Net cash provided by operating activities in 2024 was $31,471,000, a significant increase compared to a net cash used of $5,743,000 in 2023[608][609]. - Total current assets increased to $135.1 million as of December 31, 2024, compared to $99.3 million in 2023, driven by increases in cash and cash equivalents and accounts receivable[652]. - The company has a total of $160.7 million in liabilities as of December 31, 2024, up from $145.9 million in 2023[652]. - Cash and cash equivalents at the end of 2024 were $56.746 million, up from $32.786 million at the end of 2023[664]. - Operating activities generated net cash of $31.471 million in 2024, compared to a cash outflow of $5.743 million in 2023[664]. Expenses and Costs - The cost of product sales increased to $18.6 million in 2024, up from $7.1 million in 2023, primarily due to increased royalty expenses and amortization of intangible assets[586]. - Research and development expenses decreased to $23.4 million in 2024, down from $24.5 million in 2023, mainly due to reduced personnel and consulting costs[588]. - Selling, general and administrative expenses increased to $113,059,000 in 2024, up 6.9% from $105,741,000 in 2023, primarily due to increased personnel-related costs and commercial activities[599][601]. - Total costs and expenses decreased to $155.086 million in 2024 from $137.373 million in 2023, reflecting improved operational efficiency[655]. Income and Earnings - Net income for 2024 was $17.485 million, a turnaround from a net loss of $25.091 million in 2023[658]. - Basic and diluted net income per share for 2024 was $0.99, compared to a loss of $1.44 per share in 2023[655]. - The provision for income taxes for 2024 was $881,000, related to foreign withholding tax and state taxes, compared to no provision in 2023[605]. Collaboration Agreements and Future Payments - Future contingent payments under existing collaboration agreements could total approximately $1.5 billion if all potential product candidates achieve specified events[614]. - The company has collaboration agreements with multiple partners, including Lilly, Grifols, and Kissei, for various drug developments[739]. - The company received a non-refundable upfront cash payment of $125.0 million from Lilly as part of their collaboration agreement[745]. - The company received a $30.0 million upfront payment from Grifols under the commercialization license agreement, with potential total milestones of $297.5 million[753]. - The company received a $10.0 million upfront payment from Kissei for the olutasidenib license agreement, with potential additional payments of up to $152.5 million[756]. Research and Development - The company continues to advance the development of R289, a dual IRAK 1/4 inhibitor, in a Phase 1b study for lower-risk MDS patients[570]. - Strategic collaborations are ongoing with MDACC and CONNECT to evaluate olutasidenib in AML and other hematologic cancers[571]. - Research and development expenses for 2024 were $23.380 million, slightly down from $24.522 million in 2023[655]. - Research and development expenses include costs for scientific personnel wages, supplies, and payments to clinical research partners, with accruals based on contractual activities[722][723]. Stock and Equity - The company executed a 1-for-10 reverse stock split effective June 27, 2024, adjusting share amounts retroactively in the financial statements[674]. - The company’s total stockholders' equity improved to $3.3 million as of December 31, 2024, compared to a deficit of $28.6 million in 2023[652]. Liabilities and Obligations - The company has a Credit Agreement with MidCap providing for a $60 million term loan credit facility, fully funded as of December 31, 2024[618]. - The outstanding principal amount of the loan from MidCap was $60.0 million as of December 31, 2024, with $7.5 million due within the next 12 months[631]. - The company has a contractual obligation related to a third-party contract manufacturer for TAVALISSE, potentially subject to cancellation fees amounting to approximately $24.1 million, with $6.8 million due within one year and $9.3 million due within two to three years[625]. - The company recorded net liabilities for product sales allowances and discounts of $26.4 million as of December 31, 2024, reflecting adjustments for estimated government-mandated and privately-negotiated rebates and chargebacks[646].

Core Insights - Rigel Pharmaceuticals reported significant financial growth in 2024, achieving record net product sales of $144.9 million, a 39% increase from 2023, and generating a full-year net income of over $17 million for the first time [2][11][16] - The company anticipates total revenue for 2025 to be between $200 million and $210 million, with expectations of positive net income while funding clinical development programs [18] Financial Performance - Fourth quarter 2024 total revenue was approximately $57.6 million, including $31.0 million from TAVALISSE, $7.4 million from REZLIDHIA, and $8.1 million from GAVRETO [3][11] - For the full year 2024, total revenues reached approximately $179.3 million, with TAVALISSE net product sales growing 12% to $104.8 million and REZLIDHIA net product sales increasing 118% to $23.0 million [14][15] - The company reported a net income of $14.3 million for Q4 2024, compared to a net income of $0.7 million in Q4 2023, and a full-year net income of $17.5 million compared to a net loss of $25.1 million in 2023 [13][16] Product Sales and Market Expansion - TAVALISSE, REZLIDHIA, and GAVRETO showed strong commercial performance with record bottles shipped in Q4 2024 [4][11] - TAVALISSE net product sales grew 21% in Q4 2024 compared to Q4 2023, while REZLIDHIA sales surged 92% in the same period [11][12] - Rigel's partner Kissei received regulatory approval for TAVALISSE in South Korea, leading to a $3 million milestone payment for Rigel [5][6] Clinical Development - R289, a dual IRAK1/4 inhibitor, received Fast Track and Orphan Drug designations from the FDA for treating lower-risk MDS, with ongoing Phase 1b clinical studies showing promising preliminary efficacy [10][12] - Rigel is advancing olutasidenib in various studies, including a Phase 2 study for recurrent glioma and collaborations with the University of Texas MD Anderson Cancer Center [10][12] Cash Position and Future Outlook - As of December 31, 2024, Rigel had cash, cash equivalents, and short-term investments of $77.3 million, up from $61.1 million at the end of Q3 2024 [17][34] - The company expects to maintain a strong cash position while advancing its clinical development programs in 2025 [18]

Core Viewpoint - Rigel Pharmaceuticals is expected to report strong earnings for Q4 and full-year 2024, with significant growth in product sales and positive guidance for 2025 [1][6][19]. Financial Performance - The Zacks Consensus Estimate for Q4 2024 sales is $57.57 million, with earnings per share (EPS) expected at 42 cents [1]. - The EPS estimate for 2024 has increased from 17 cents to 22 cents over the past 60 days, while the 2025 EPS estimate has risen from 92 cents to $1.05 [1][2]. - Rigel's total revenues for Q4 2024 are projected to be $57.6 million, up from $35.8 million in the same period last year [6]. Product Sales - Tavalisse is expected to generate quarterly net product sales of $31.0 million, contributing significantly to Rigel's revenue growth [6]. - The company anticipates net product sales of $7.4 million from Rezlidhia and $8.1 million from Gavreto [8][9]. - Total revenues for 2024 are expected to reach $179.3 million, including net product sales of $144.9 million and contract revenues of $34.4 million [11]. Market Position and Valuation - Rigel's shares have increased by 50.6% over the past year, contrasting with a 13.4% decline in the industry [12]. - The current price/sales ratio for Rigel is 1.86x forward sales, lower than its historical mean of 2.37x but higher than the drug industry average of 1.64x [13]. Growth Outlook - Rigel expects total revenues of approximately $200-$210 million in 2025, with product sales projected between $185-$192 million [16]. - The company anticipates achieving positive net income in 2025 while continuing to fund clinical development programs [16]. - Rigel's pipeline includes promising candidates, with R289 receiving Orphan Drug and Fast Track designations for the treatment of myelodysplastic syndromes [17][18].

SOUTH SAN FRANCISCO, Calif., Feb. 25, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will report its fourth quarter and full year 2024 financial results after market close on Tuesday, March 4, 2025. 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 ...