PART I FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Rigel Pharmaceuticals achieved net income in Q1 2025, driven by an 81% revenue increase to $53.3 million, improving assets and equity [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, total assets increased to $176.0 million, and stockholders' equity significantly improved to $18.6 million from $3.3 million Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $45,728 | $56,746 | | Total current assets | $146,563 | $135,103 | | Total assets | $175,972 | $163,976 | | **Liabilities & Equity** | | | | Total current liabilities | $66,629 | $63,299 | | Total liabilities | $157,405 | $160,688 | | Total stockholders' equity | $18,567 | $3,288 | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) The company reported a net income of $11.4 million for Q1 2025, a significant turnaround from a loss, driven by 81% revenue growth Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product sales, net | $43,550 | $26,003 | | Contract revenues from collaborations | $9,783 | $3,531 | | **Total revenues** | **$53,333** | **$29,534** | | Total costs and expenses | $40,560 | $36,500 | | **Income (loss) from operations** | **$12,773** | **($6,966)** | | **Net income (loss)** | **$11,446** | **($8,247)** | | Basic EPS | $0.64 | ($0.47) | | Diluted EPS | $0.63 | ($0.47) | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved to -$0.9 million in Q1 2025, with overall cash decreasing by $11.0 million Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($893) | ($5,013) | | Net cash (used in) provided by investing activities | ($10,552) | $313 | | Net cash provided by (used in) financing activities | $484 | ($2,512) | | **Net decrease in cash, cash equivalents and restricted cash** | **($10,961)** | **($7,212)** | [Notes to Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail Rigel's business, FDA-approved products, revenue recognition, and confirm $77.1 million cash sufficient for 12 months - The company has three FDA-approved products: TAVALISSE® for chronic immune thrombocytopenia (ITP), REZLIDHIA® for relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation, and GAVRETO® for RET fusion-positive non-small cell lung cancer (NSCLC) and thyroid cancer[20](index=20&type=chunk)[21](index=21&type=chunk)[22](index=22&type=chunk) - As of March 31, 2025, the company had approximately **$77.1 million** in cash, cash equivalents, and short-term investments and believes these funds are sufficient for at least the next 12 months[28](index=28&type=chunk)[29](index=29&type=chunk) - Total future contingent payments to Rigel from all existing collaboration agreements could amount to approximately **$1.5 billion**, contingent on partners achieving specific development, regulatory, and commercial milestones[41](index=41&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=41&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes strong Q1 2025 performance to robust product sales growth and advancing pipeline, with $77.1 million capital sufficient for 12 months [Overview and Business Updates](index=42&type=section&id=Overview%20and%20Business%20Updates) Rigel, a biotechnology firm, saw significant Q1 2025 sales growth for TAVALISSE, REZLIDHIA, and GAVRETO, while advancing its R289 program Q1 2025 Net Product Sales (in millions) | Product | Q1 2025 Net Sales | YoY Growth | | :--- | :--- | :--- | | TAVALISSE | $28.5 | 35% | | REZLIDHIA | $6.1 | 25% | | GAVRETO | $9.0 | N/A | - The R289 (IRAK 1/4 inhibitor) program is advancing in a Phase 1b study for lower-risk Myelodysplastic Syndrome (MDS), with ongoing enrollment in the sixth dose level[125](index=125&type=chunk) - The FDA has granted R289 Orphan Drug and Fast Track designations[126](index=126&type=chunk) - On April 30, 2025, Rigel notified its partner Lilly that it would not exercise its opt-in right for co-funding ocadusertib development, releasing a **$40.0 million** cost-share liability from Rigel's balance sheet[131](index=131&type=chunk)[51](index=51&type=chunk) [Our Product Portfolio](index=47&type=section&id=Our%20Product%20Portfolio) Rigel's portfolio includes three commercial products and a clinical pipeline led by R289, with partnered programs like Ocadusertib Product Portfolio Summary | Product | Indication | Target | Stage | Partner | | :--- | :--- | :--- | :--- | :--- | | **Commercialized Products** | | | | | | TAVALISSE® (fostamatinib) | Adult Chronic ITP | SYK | Approved | - | | REZLIDHIA® (olutasidenib) | R/R AML | mIDH1 | Approved | - | | GAVRETO® (pralsetinib) | RET+ NSCLC & Advanced Thyroid Cancer | RET | Approved | - | | **Clinical Trials** | | | | | | R289 | Lower-risk MDS | IRAK1/4 | Phase 1b | - | | **Partnered Programs** | | | | | | Ocadusertib (systemic) | Rheumatoid Arthritis | RIPK1 | Phase 2 | Lilly | [Results of Operations](index=63&type=section&id=Results%20of%20Operations) Q1 2025 total revenues surged to $53.3 million due to product and collaboration sales, while R&D increased and SG&A decreased Revenue Breakdown (in thousands) | Revenue Source | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Product sales, net | $43,550 | $26,003 | $17,547 | | Contract revenues from collaborations | $9,783 | $3,531 | $6,252 | | **Total revenues** | **$53,333** | **$29,534** | **$23,799** | - The increase in net product sales was driven by a **35% rise** in TAVALISSE sales, a **25% rise** in REZLIDHIA sales, and **$9.0 million** in new sales from GAVRETO[191](index=191&type=chunk) - Research and development expenses increased by **$2.4 million** YoY, primarily due to higher clinical trial costs for the ongoing IRAK 1/4 inhibitor program and olutasidenib development programs[196](index=196&type=chunk)[197](index=197&type=chunk) - Selling, general and administrative expenses decreased by **$0.7 million** YoY, mainly because of a **$2.0 million** reduction in stock-based compensation expense related to performance-based awards[207](index=207&type=chunk)[208](index=208&type=chunk) [Liquidity and Capital Resources](index=69&type=section&id=Liquidity%20and%20Capital%20Resources) Rigel held $77.1 million in cash as of March 31, 2025, sufficient for 12 months, with a $60.0 million term loan and potential ATM offering - The company had **$77.1 million** in cash, cash equivalents, and short-term investments as of March 31, 2025, and believes this is sufficient to fund operations for at least the next 12 months[216](index=216&type=chunk)[220](index=220&type=chunk) - Rigel has a fully funded **$60.0 million** term loan credit facility with MidCap, with principal payments of **$15.0 million** due within the next 12 months[224](index=224&type=chunk)[234](index=234&type=chunk) - The company has an active at-the-market (ATM) offering agreement to sell up to **$100.0 million** of common stock, though no shares had been sold under this agreement as of March 31, 2025[223](index=223&type=chunk) - As of March 31, 2025, the company has a contractual manufacturing obligation for TAVALISSE that could result in cancellation fees of approximately **$20.8 million**[230](index=230&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=74&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk disclosures occurred in Q1 2025, with primary risks remaining interest rate sensitivities - There were no material changes to market risk disclosures during the three months ended March 31, 2025, with primary risks related to interest rate sensitivities[237](index=237&type=chunk) [Controls and Procedures](index=76&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - The principal executive officer and principal financial officer concluded that as of March 31, 2025, the company's disclosure controls and procedures were **effective**[239](index=239&type=chunk) - No changes occurred in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[240](index=240&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=76&type=section&id=Item%201.%20Legal%20Proceedings) Rigel settled patent litigation with Annora Pharma in March 2025, licensing generic TAVALISSE sales from Q2 2032 - The company settled patent litigation with Annora Pharma in March 2025 regarding a generic version of TAVALISSE[244](index=244&type=chunk) - Under the settlement, Annora will have a license to sell its generic product starting in **Q2 2032**, or earlier under certain circumstances[244](index=244&type=chunk) [Risk Factors](index=77&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including product dependency, clinical trial failures, generic competition, and regulatory challenges - The company's prospects are highly dependent on the commercial success of its existing products, and any diminishment could adversely affect the business[247](index=247&type=chunk) - There is a high risk that drug discovery and development efforts may not generate successful product candidates, and clinical trial failures could harm commercial prospects[247](index=247&type=chunk)[257](index=257&type=chunk) - The business is subject to stringent healthcare regulations, privacy laws, and cybersecurity threats, with non-compliance potentially leading to significant fines and penalties[247](index=247&type=chunk)[267](index=267&type=chunk) - Approval of generic versions of the company's products could significantly harm the business, as highlighted by the recent settlement of patent litigation with Annora[247](index=247&type=chunk)[307](index=307&type=chunk)[310](index=310&type=chunk)

Core Viewpoint - Rigel Pharmaceuticals reported strong financial results for Q1 2025, with significant revenue growth and net income, positioning the company for continued investment in its pipeline and commercial growth [2][5][6]. Financial Performance - Total revenues for Q1 2025 were $53.3 million, comprising $43.6 million in net product sales and $9.8 million in contract revenues, marking a 68% increase in net product sales compared to $26.0 million in Q1 2024 [5][9]. - Net income for the quarter was $11.4 million, or $0.64 per share, a turnaround from a net loss of $8.2 million in the same period of 2024 [9][26]. - The company anticipates total revenue for 2025 to be approximately $200 to $210 million, excluding $40 million in non-cash revenue expected in Q2 2025 [6][11]. Product Sales - TAVALISSE net product sales reached $28.5 million, a 35% increase from $21.1 million in Q1 2024 [5][7]. - GAVRETO, which became commercially available in June 2024, generated $9.0 million in net product sales [5][7]. - REZLIDHIA net product sales were $6.1 million, reflecting a 25% increase from $4.9 million in the same period of 2024 [5][7]. Clinical Development - The company is advancing its Phase 1b clinical study of R289 for patients with relapsed or refractory lower-risk myelodysplastic syndromes (MDS) [2][7]. - R289 has received Orphan Drug and Fast Track designations from the FDA for the treatment of MDS [6][7]. Corporate Developments - Rigel appointed Dr. Mark Frohlich to its Board of Directors as an independent director [7]. - The company entered a settlement agreement with Annora Pharma regarding patent litigation related to TAVALISSE, allowing Annora to sell a generic version by Q2 2032 under certain conditions [7][8]. - Rigel notified Eli Lilly that it will not exercise its opt-in right for the development of ocadusertib, expecting to recognize approximately $40 million in non-cash revenue in Q2 2025 as a result [7][8]. Cost Structure - Total costs and expenses for Q1 2025 were $40.6 million, up from $36.5 million in Q1 2024, primarily due to increased personnel and research and development costs [8][26].

Core Insights - Rigel Pharmaceuticals, Inc. will report its first quarter 2025 financial results on May 6, 2025, after market close [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] Financial Reporting - The financial results will be discussed in a conference call accessible via domestic and international dialing options [2] - The webcast will be archived for 90 days for replay on the company's website [2] Company Overview - Rigel Pharmaceuticals was founded in 1996 and is based in South San Francisco, California [3] - The company is dedicated to discovering and developing novel therapies to improve patient lives [3]

Rigel Pharmaceuticals (RIGL) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a chan ...

Scientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not re ...

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]