Group 1 - Rigel Pharmaceuticals reported quarterly earnings of $0.63 per share, significantly exceeding the Zacks Consensus Estimate of $0.14 per share, and compared to a loss of $0.50 per share a year ago, representing an earnings surprise of 350% [1] - The company achieved revenues of $53.33 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 22.07%, and up from $29.53 million in the same quarter last year [2] - Rigel has consistently outperformed consensus EPS and revenue estimates over the last four quarters, indicating strong operational performance [2] Group 2 - The stock has increased approximately 13.6% since the beginning of the year, contrasting with a -3.9% decline in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $0.31 on revenues of $48.14 million, and for the current fiscal year, it is $1.19 on revenues of $199.1 million [7] - The Medical - Drugs industry, to which Rigel belongs, is currently ranked in the top 22% of over 250 Zacks industries, suggesting a favorable outlook for the sector [8]

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].

WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number 0-29889 Rigel Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 94-3248524 (St ...

SOUTH SAN FRANCISCO, Calif., May 6, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today reported financial results for the first quarter ended March 31, 2025, including sales of TAVALISSE® (fostamatinib disodium hexahydrate), GAVRETO® (pralsetinib) and REZLIDHIA® (olutasidenib), and recent business progress. "Our first quarter results reflect the continued strength of our growing commercial business. Thi ...

Contact for Investors & Media: Investors: Rigel Pharmaceuticals, Inc. 650.624.1232 [email protected] Media: David Rosen Argot Partners Phone: 646.461.6387 SOURCE Rigel Pharmaceuticals, Inc. SOUTH SAN FRANCISCO, Calif., April 29, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will report its first quarter 2025 financial results after market close on Tuesday, May 6, 2025. Rigel senior management will follow the announcement with a live conference call and webcast at 4: ...

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 ...