Financial Data and Key Metrics Changes - The company reported total revenue of $53.3 million for Q1 2025, with a year-over-year net product sales growth of 68% [4][40] - Net income for the quarter was $11.4 million, a significant improvement from a net loss of $8.2 million in the same period of 2024 [4][43] - The company anticipates total revenue for 2025 to be in the range of $200 million to $210 million, with net product sales expected to be approximately $185 million to $192 million [6][45] Business Line Data and Key Metrics Changes - TAVALISSE generated net product sales of $28.5 million, a 35% increase year-over-year [40] - GAVRETO, which became available in June 2024, reported net product sales of $9 million, reflecting a 15% year-over-year growth [10][40] - Reslidia achieved net product sales of $6.1 million, marking a 25% increase compared to the prior year [40] Market Data and Key Metrics Changes - The company is expanding access to its products in international markets, with TAVALISSE now available in Japan, Europe, Canada, and Israel [16] - Regulatory approvals for TAVALISSE have been received in Mexico and South Korea, indicating growth opportunities in these regions [16] Company Strategy and Development Direction - The company aims to continue focusing on commercial growth while maintaining financial discipline, with plans to expand its hematology and oncology portfolio through business development [6][19] - The company is committed to advancing its development pipeline, particularly with R289 and elutacitinib, and plans to initiate a Phase II study in recurrent glioma later this year [18][39] - The company has a strategic alliance with MD Anderson Cancer Center to broaden the development of elutacitinib into AML and MDS [36] Management's Comments on Operating Environment and Future Outlook - Management highlighted a strong start to the year despite a challenging business environment for the biotech market, emphasizing the robustness of the corporate strategy [4][6] - The company expects to report positive net income for the full year of 2025 while funding existing and new clinical development programs [45][47] Other Important Information - The company notified Lilly that it will not exercise its right to share in future development expenses for ogadusertib, which may impact future royalty rates [7] - The company reported a sequential decrease in net product sales from Q4 2024 due to inventory drawdowns across distribution channels [41] Q&A Session Summary Question: Clarification on the Target D program and its objectives - Management explained that the Target D program is an umbrella study for patients post-surgery and radiotherapy, while the company's own clinical study will target a different patient population [50][51] Question: Commentary on product sales and first-quarter resets - Management expressed satisfaction with the growth in demand for all three brands, indicating that they were prepared for changes related to the Inflation Reduction Act [60][63] Question: Expectations for R289 and dose escalation - Management confirmed that they are exploring split doses and will seek regulatory feedback on dose escalation data before advancing to the recommended Phase II dose [68][71] Question: Inquiry about ANDA filers and market entry - Management clarified that while there are no current ANDA filers, it is technically possible for second filers to enter the market if they can defeat existing patents [72][74]

Financial Performance - Q1 2025 net product sales grew to $43.6 million, a 68% increase compared to Q1 2024[18, 92] - TAVALISSE net product sales in Q1 2025 were $28.5 million, a 35% increase compared to Q1 2024[20] - GAVRETO net product sales in Q1 2025 were $9.0 million[22] - REZLIDHIA net product sales in Q1 2025 were $6.1 million[22] - Collaboration revenues for Q1 2025 totaled $9.8 million[92] - Rigel anticipates 2025 total revenue of approximately $200 million to $210 million[96] - The company projects net product sales of approximately $185 million to $192 million for 2025, representing a 28% to 32% year-over-year growth[97, 98] Clinical Development Programs - Rigel is evaluating R289, a dual IRAK1/4 inhibitor, in a Phase 1b study for relapsed/refractory lower-risk MDS[13] - The company plans to initiate a Phase 2 study of olutasidenib in recurrent glioma[13] - Preliminary data from the R289 Phase 1b study in relapsed/refractory lower-risk MDS showed that at 500 & 750 mg QD doses, RBC-TI/HI-E responses occurred in 40% of evaluable TD patients[59] Strategic Initiatives - Rigel is focused on identifying and in-licensing new late-stage assets that leverage current capabilities and capacity[10] - The company expanded its relationship with Kissei to include REZLIDHIA in Japan, the Republic of Korea, and Taiwan and entered into a relationship with Dr Reddy's in Latin America and other territories[29]

Financial Data and Key Metrics Changes - The company reported total revenue of $53.3 million for Q1 2025, with a year-over-year net product sales growth of 68% [4][43] - Net income for the quarter was $11.4 million, compared to a net loss of $8.2 million in the same period in 2024 [46] - The company anticipates total revenue for 2025 to be between $200 million and $210 million, with net product sales expected to be approximately $185 million to $192 million [48][50] Business Line Data and Key Metrics Changes - TAVALISSE generated net product sales of $28.5 million, a 35% increase year-over-year [43] - GAVRETO achieved net product sales of $9 million, marking a 15% year-over-year growth since its acquisition [11][43] - Reslidia reported net product sales of $6.1 million, reflecting a 25% increase compared to the prior year [43] Market Data and Key Metrics Changes - The company is expanding access to its products in international markets, with TAVALISSE now available in Japan, Europe, Canada, and Israel [16][17] - Regulatory approvals for TAVALISSE have been received in Mexico and South Korea, enhancing market presence [17] Company Strategy and Development Direction - The company aims to grow its commercial business while advancing its development pipeline, focusing on hematology and oncology [50][51] - Plans include initiating a Phase II study for elutacitinib in recurrent glioma and continuing support for collaborations with MD Anderson and CONNECT [40][51] - The company is committed to maintaining financial discipline while investing in clinical development programs [48][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's robust strategy despite challenging market conditions, particularly in the biotech sector [4][6] - The company anticipates continued growth in net product sales by approximately 30% year-over-year in 2025 [50] - Management highlighted the importance of addressing unmet medical needs in lower risk MDS and glioma through their development programs [19][34] Other Important Information - The company will not exercise its right to share in future development expenses for the RIPK1 inhibitor program partnered with Lilly, opting to focus on internal pipeline assets [7][8] - The company expects to recognize approximately $40 million in non-cash collaboration revenue in Q2 related to the Lilly agreement [44] Q&A Session Summary Question: Clarification on the Target D program and its objectives - Management clarified that the Target D program is an umbrella study for a unique patient population, while the company-sponsored Phase II trial will target a different patient group [54][56] Question: Commentary on product sales and market environment - Management expressed satisfaction with the growth in demand for all three brands and indicated that they were prepared for changes related to the Inflation Reduction Act [64][66] Question: Expectations for R289 and regulatory feedback - Management confirmed that they will seek FDA input on dose selection for R289 before advancing to the Phase II dose [72][74] Question: Inquiry about ANDA filers and market entry - Management stated that there are currently no additional ANDA filers that they are aware of, and any new entrants would need to defeat existing patents [59][75]

Financial Performance - Total revenue for Q1 2025 was approximately $53.3 million, consisting of $43.6 million in net product sales and $9.8 million in contract revenues from collaborations[5]. - Net product sales increased by 68% compared to Q1 2024, driven by the expansion of the commercial portfolio, including TAVALISSE, GAVRETO, and REZLIDHIA[6]. - Rigel reported a net income of $11.4 million for Q1 2025, compared to a net loss of $8.2 million in the same period of 2024[10]. - 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[13]. - Total revenues for Q1 2025 reached $53.333 million, a 80.5% increase from $29.534 million in Q1 2024[32]. - Product sales, net, amounted to $43.550 million, up from $26.003 million, reflecting a 67.8% year-over-year growth[32]. - Net income for Q1 2025 was $11.446 million, compared to a net loss of $8.247 million in Q1 2024, marking a significant turnaround[32]. - Basic net income per share increased to $0.64 from a loss of $0.47 per share in the same quarter last year[32]. Sales Performance - TAVALISSE net product sales were $28.5 million, a growth of 35% from $21.1 million in Q1 2024[8]. - GAVRETO net product sales were $9.0 million, having become commercially available in June 2024[8]. Expenses and Costs - Total costs and expenses for Q1 2025 were $40.6 million, an increase from $36.5 million in Q1 2024, primarily due to higher personnel and R&D costs[9]. - Research and development expenses rose to $8.436 million, up from $6.026 million, indicating continued investment in innovation[32]. - Cost of product sales increased to $4.409 million from $2.025 million, which is a 117.5% increase, reflecting higher sales volume[32]. - Selling, general and administrative expenses were $27.715 million, a slight decrease from $28.449 million year-over-year[32]. Financial Position - Cash, cash equivalents, and short-term investments as of March 31, 2025, were $77.1 million, slightly down from $77.3 million at the end of 2024[11]. - Stockholders' equity improved significantly to $18.567 million as of March 31, 2025, compared to $3.288 million at the end of 2024[34]. - Total assets increased to $175.972 million from $163.976 million, reflecting a solid financial position[34]. - The company reported interest income of $591,000, slightly down from $593,000 in the previous year[32]. Future Outlook - Rigel expects to report positive net income for the full year 2025 while funding existing and new clinical development programs[14]. - Rigel's R289 received Orphan Drug and Fast Track designations from the FDA for the treatment of myelodysplastic syndromes (MDS)[5].

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]