Rigel(RIGL) - 2025 Q2 - Quarterly Results

Financial & Business Highlights Rigel's Q2 2025 featured 76% net product sales growth, $59.6 million net income, increased cash, and raised full-year guidance Key Financial Highlights | Metric | Q2 2025 ($ millions) | YoY Change | | :--- | :--- | :--- | | Net Product Sales | $58.9 | +76% | | Total Revenue | $101.7 | N/A | | Net Income | $59.6 | From Net Loss | | Cash & Equivalents | $108.4 | +40% vs Dec 2024 | - The company raised its 2025 total revenue guidance to a range of $270 to $280 million, a significant increase from the previous guidance of $200 to $210 million[3][6][17] - Enrollment was completed in the dose escalation part of the Phase 1b study for R289, a dual IRAK1/4 inhibitor for patients with relapsed or refractory lower-risk myelodysplastic syndrome (MDS)[3][5][6] Business Update Rigel opted out of ocadusertib co-development, recognizing $40.0 million non-cash revenue, and advanced R289 clinical trials Commercial & Corporate Rigel opted out of ocadusertib co-development, recognizing $40.0 million non-cash revenue, and Kissei launched TAVALISSE in South Korea - Rigel notified Eli Lilly it would not exercise its opt-in right for ocadusertib, resulting in the recognition of $40.0 million in non-cash revenue from the release of a cost-share liability, with Rigel remaining entitled to future milestones and royalties[4] - Rigel's partner, Kissei Pharmaceutical, announced the commercial launch of TAVALISSE in South Korea in early July through its licensing partner, JW Pharmaceutical Corporation[7] Clinical Development & Publications R289 Phase 1b dose escalation completed, with expansion planned; GAVRETO and REZLIDHIA data presented; and olutasidenib papers published - Enrollment in the dose escalation part of the Phase 1b study for R289 in patients with lower-risk MDS was completed in July, with plans to share updated data and initiate the dose expansion part later in the year[5] - Rigel presented 4 posters at the ASCO Annual Meeting and 3 posters at the EHA Congress, including final data for GAVRETO in NSCLC and supportive data for REZLIDHIA in AML[8] - Key publications included a paper in Leukemia & Lymphoma on the effectiveness of olutasidenib versus ivosidenib and a paper in Blood Advances on olutasidenib's use in MDS[12] Second Quarter 2025 Financial Results Rigel's Q2 2025 total revenues reached $101.7 million, with $59.6 million net income, a significant turnaround from prior year loss Q2 2025 Performance Q2 2025 total revenue reached $101.7 million, with $59.6 million net income, driven by product sales and a $40 million non-cash revenue Q2 Revenue Breakdown | Revenue Source | Q2 2025 ($ millions) | Q2 2024 ($ millions) | | :--- | :--- | :--- | | Net Product Sales | $58.9 | $33.5 | | Contract Revenues | $42.7 | $3.4 | | Total Revenues | $101.7 | $36.8 | Q2 Product Net Sales | Product | Q2 2025 Net Sales ($ millions) | YoY Growth | | :--- | :--- | :--- | | TAVALISSE | $40.1 | +52% | | GAVRETO | $11.8 | N/A (Launched June 2024) | | REZLIDHIA | $7.0 | +36% | Q2 Net Income (Loss) and EPS | Metric | Q2 2025 ($ millions) | Q2 2024 ($ millions) | | :--- | :--- | :--- | | Net Income (Loss) | $59.6 | ($1.0) | | Diluted EPS | $3.28 | ($0.06) | Year-to-Date (YTD) 2025 Performance YTD 2025 total revenues reached $155.0 million, with $71.1 million net income, and cash increased to $108.4 million YTD Revenue Breakdown | Revenue Source | YTD 2025 ($ millions) | YTD 2024 ($ millions) | | :--- | :--- | :--- | | Net Product Sales | $102.5 | $59.5 | | Contract Revenues | $52.5 | $6.9 | | Total Revenues | $155.0 | $66.4 | YTD Net Income (Loss) and EPS | Metric | YTD 2025 ($ millions) | YTD 2024 ($ millions) | | :--- | :--- | :--- | | Net Income (Loss) | $71.1 | ($9.3) | | Diluted EPS | $3.91 | ($0.53) | - Cash, cash equivalents and short-term investments increased to $108.4 million as of June 30, 2025, compared to $77.3 million as of December 31, 2024[16] 2025 Financial Outlook Rigel significantly raised its full-year 2025 total revenue guidance to $270-$280 million, anticipating positive net income 2025 Financial Guidance Update | 2025 Guidance | Updated Range ($ millions) | Previous Range ($ millions) | | :--- | :--- | :--- | | Total Revenue | $270 - $280 | $200 - $210 | | Net Product Sales | $210 - $220 | $185 - $192 | | Contract Revenues | ~$60 | $15 - $18 | - The company anticipates it will report positive net income for the full year 2025[17] - The total revenue and contract revenue guidance includes $40 million in non-cash contract revenue related to the agreement with Lilly[17] Product & Disease Area Overview This section outlines Rigel's three commercial products—TAVALISSE, GAVRETO, and REZLIDHIA—and their respective target diseases Marketed Products Rigel's portfolio includes three FDA-approved products: TAVALISSE for ITP, GAVRETO for RET fusion-positive cancers, and REZLIDHIA for IDH1-mutated AML - TAVALISSE (fostamatinib) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment[25] - GAVRETO (pralsetinib) is indicated for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and for adult and pediatric patients 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer[26] - REZLIDHIA (olutasidenib) is indicated for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation[28] Target Disease Areas This section describes the target diseases: Immune Thrombocytopenia (ITP), RET fusion-positive NSCLC, and Acute Myeloid Leukemia (AML) - In Immune Thrombocytopenia (ITP), the immune system destroys blood platelets, leading to a risk of severe bleeding, with a significant medical need remaining for patients who do not respond to existing therapies[21] - Non-small cell lung cancer (NSCLC) accounts for 85-90% of all lung cancers, with RET fusions implicated in approximately 1-2% of patients[22] - Acute Myeloid Leukemia (AML) is a rapidly progressing blood cancer, with an unmet need for well-tolerated treatments for patients with relapsed or refractory disease[23][24] Financial Statements This section presents detailed, unaudited financial statements for Q2 and YTD 2025, including Statements of Operations and a Summary Balance Sheet Statements of Operations The Statements of Operations provides a detailed income statement for Q2 and YTD 2025, breaking down revenues, expenses, and net income/loss Consolidated Statements of Operations (Unaudited) | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $101,685 | $36,841 | $155,018 | $66,375 | | Total costs and expenses | $40,582 | $36,394 | $81,142 | $72,894 | | Income (loss) from operations | $61,103 | $447 | $73,876 | ($6,519) | | Net income (loss) | $59,613 | ($1,030) | $71,059 | ($9,277) | | Diluted net income (loss) per share | $3.28 | ($0.06) | $3.91 | ($0.53) | Summary Balance Sheet Data The Summary Balance Sheet presents key figures as of June 30, 2025, highlighting increased cash to $108.4 million and stockholders' equity to $81.9 million Summary Balance Sheet Data (Unaudited) | (in thousands) | As of June 30, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $108,378 | $77,321 | | Total assets | $206,736 | $163,976 | | Stockholders' equity | $81,934 | $3,288 |