Rigel(RIGL) - 2024 Q3 - Quarterly Results

Q3 2024 Financial & Business Highlights Rigel reported strong Q3 2024 results with $55.3 million total revenue, achieving profitability and advancing key commercial and clinical initiatives including a REZLIDHIA licensing deal Q3 2024 Revenue Breakdown | Metric | Amount | | :--- | :--- | | Total Revenue | $55.3 million | | TAVALISSE Net Product Sales | $26.3 million | | REZLIDHIA Net Product Sales | $5.5 million | | GAVRETO Net Product Sales | $7.1 million | - Entered into an agreement with Kissei to develop and commercialize REZLIDHIA in Japan, the Republic of Korea, and Taiwan, receiving a $10.0 million upfront cash payment[1][4] - Initial data from the Phase 1b study of R289, a dual IRAK1/4 inhibitor, in lower-risk myelodysplastic syndrome (LR-MDS) will be presented at the 66th ASH Annual Meeting[1] - The company's focus on financial discipline resulted in a positive third-quarter and year-to-date net income[2] Business Update Rigel's business update highlights continued commercial momentum, successful GAVRETO integration, a key REZLIDHIA licensing deal, and clinical advancements for R289 and REZLIDHIA combination therapy Commercial Update Rigel's commercial portfolio showed continued strength with record bottle shipments, successful GAVRETO patient transition, and a significant REZLIDHIA licensing agreement with Kissei Product Bottle Shipments | Product | Bottles Shipped to Patients/Clinics | Change in Distribution Channel | Total Bottles Shipped | | :--- | :--- | :--- | :--- | | TAVALISSE | 2,797 | (4) | 2,793 | | REZLIDHIA | 444 | (15) | 429 | | GAVRETO | 717 | 35 | 752 | - Entered an exclusive license agreement with Kissei for REZLIDHIA in Japan, South Korea, and Taiwan, receiving a $10.0 million upfront payment with potential for up to an additional $152.5 million in milestones[4] - Successfully transitioned existing GAVRETO patients to Rigel's product following its commercial launch in June 2024. A Dear Health Care Provider (DHCP) letter was issued in October regarding a new safety signal for GAVRETO[3][5] Clinical and Development Update Rigel is advancing its clinical pipeline, highlighted by the ongoing Phase 1b study of R289 in LR-MDS with positive initial data and the initiation of a REZLIDHIA combination therapy trial - Initial data from the Phase 1b study of R289 in R/R LR-MDS showed the drug was well-tolerated. RBC-transfusion independence (RBC-TI) or hematologic improvement (HI-E) occurred in 36% of patients receiving doses ≥500 mg QD[7] - Enrollment is underway in the fifth dose level (500mg / 250mg split dose) of the R289 Phase 1b study[6] - The first patient was enrolled in a Phase 1b/2 triplet therapy trial of REZLIDHIA in combination with decitabine and venetoclax, sponsored by MD Anderson Cancer Center[6] Financial Performance Analysis Rigel demonstrated a significant financial turnaround, achieving profitability in Q3 and year-to-date 2024, driven by robust revenue growth from product sales and contract revenue, alongside improved cash position Third Quarter 2024 Financial Results Rigel's Q3 2024 total revenues surged to $55.3 million from $28.1 million in Q3 2023, driven by product sales and contract revenues, resulting in a net income of $12.4 million or $0.70 diluted EPS Q3 2024 Financial Summary | Financial Metric (in millions, except EPS) | Q3 2024 | Q3 2023 | YoY Change | | :--- | :--- | :--- | :--- | | Total Revenues | $55.3 | $28.1 | +96.6% | | TAVALISSE Net Sales | $26.3 | $24.5 | +7.3% | | REZLIDHIA Net Sales | $5.5 | $2.7 | +103.7% | | GAVRETO Net Sales | $7.1 | N/A | N/A | | Contract Revenue | $16.4 | $1.0 | +1540% | | Total Costs & Expenses | $41.3 | $32.6 | +26.7% | | Net Income (Loss) | $12.4 | ($5.7) | Turned to Profit | | Diluted EPS | $0.70 | ($0.33) | Turned to Profit | - The increase in costs and expenses was mainly due to higher cost of product sales, a sublicensing fee to Forma, increased royalties, amortization of intangible assets, and higher personnel and commercial-related expenses[8] Year-to-Date (Nine Months) 2024 Financial Results For the nine months ended September 30, 2024, total revenues reached $121.7 million, a 50% increase, resulting in a net income of $3.1 million or $0.18 diluted EPS, reversing prior-year losses Year-to-Date Financial Summary | Financial Metric (in millions, except EPS) | YTD 2024 | YTD 2023 | YoY Change | | :--- | :--- | :--- | :--- | | Total Revenues | $121.7 | $81.1 | +50.1% | | TAVALISSE Net Sales | $73.8 | $68.1 | +8.4% | | REZLIDHIA Net Sales | $15.6 | $6.7 | +132.8% | | GAVRETO Net Sales | $9.0 | N/A | N/A | | Contract Revenue | $23.3 | $5.3 | +339.6% | | Total Costs & Expenses | $114.1 | $103.5 | +10.2% | | Net Income (Loss) | $3.1 | ($25.8) | Turned to Profit | | Diluted EPS | $0.18 | ($1.49) | Turned to Profit | - The increase in year-to-date costs was driven by higher cost of product sales and commercial expenses, partially offset by decreased R&D costs due to the timing of clinical trial activities[11] Balance Sheet and Cash Position As of September 30, 2024, Rigel's cash, cash equivalents, and short-term investments increased to $61.1 million, with total assets growing to $139.4 million Balance Sheet Summary | Balance Sheet Item (in millions) | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents & short-term investments | $61.1 | $56.9 | | Total Assets | $139.4 | $117.2 | | Stockholders' Deficit | ($14.6) | ($28.6) | Company and Product Portfolio Overview Rigel Pharmaceuticals is a biotechnology company focused on hematologic disorders and cancer, with a commercial portfolio including TAVALISSE, REZLIDHIA, and GAVRETO for various indications Marketed Products Rigel markets three key products: TAVALISSE for chronic ITP, REZLIDHIA for relapsed or refractory AML with IDH1 mutation, and GAVRETO for metastatic RET fusion-positive NSCLC and thyroid cancer - TAVALISSE (fostamatinib): Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment[20] - REZLIDHIA (olutasidenib): Indicated for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation[21] - GAVRETO (pralsetinib): Indicated for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and for adult and pediatric patients (12+) with advanced or metastatic RET fusion-positive thyroid cancer[22] Target Diseases Rigel's therapeutic focus addresses significant unmet needs in Immune Thrombocytopenia (ITP), Acute Myeloid Leukemia (AML), and Non-Small Cell Lung Cancer (NSCLC) - Immune Thrombocytopenia (ITP): An autoimmune disorder where the body attacks its own platelets, leading to excessive bruising and bleeding[16] - Acute Myeloid Leukemia (AML): A rapidly progressing cancer of the blood and bone marrow, primarily affecting adults. Relapsed or refractory AML presents a significant treatment challenge[17][18] - Non-Small Cell Lung Cancer (NSCLC): The most common type of lung cancer, accounting for 80-85% of all diagnoses. RET fusions are implicated in approximately 1-2% of NSCLC cases[19]