TAVALISSE

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Rigel Pharmaceuticals (RIGL) Earnings Call Presentation
2025-07-03 13:13
Corporate Presentation August 6, 2024 1 Forward Looking Statements Please visit www.TAVALISSE.com for Full Prescribing Information. Please visit www.REZLIDHIA.com for Full Prescribing Information, including Boxed WARNING. Please visit www.GAVRETO.com for Full Prescribing Information. 2 Growing Our Hematology and Oncology Business Commercial Execution Development & Expansion Development Programs1 In-Licensing and Product Acquisition • Identify new late-stage assets which leverage current capabilities and cap ...
Rigel Pharmaceuticals (RIGL) 2025 Conference Transcript
2025-06-04 17:50
Rigel Pharmaceuticals (RIGL) 2025 Conference June 04, 2025 12:50 PM ET Speaker0 This is standard presentation. Welcome, Rahul. Thank you so much, Farshan. It's nice to see you and my thanks to our colleagues at Jefferies for having invited us again. I appreciate the opportunity. I'd like to tell you about Rigel and where we are. First, some important forward looking statements here. This is also available on our website, so please feel free to read this. Let me tell you where Rigel is right now. It's a pret ...
Knight Therapeutics Reports First Quarter 2025 Results
Globenewswire· 2025-05-08 11:30
Financial Results - Revenues for Q1-25 were $88,076, an increase of $1,472 or 2% compared to Q1-24, driven by growth in key promoted products, partially offset by declines in mature products and currency depreciation in select LATAM countries [7][13] - Gross margin decreased to $34,866 or 40% of revenues from $41,699 or 48% in the same period last year, primarily due to hyperinflation accounting in Argentina [7][19] - Operating loss was $5,537 compared to an operating income of $2,660 in Q1-24 [11][25] - Net income was $2,185, a significant improvement from a net loss of $4,546 in the prior year [25] - Adjusted revenues were $87,979, reflecting a 3% increase, and $6,631 or 8% on a constant currency basis [7][13] Corporate Developments - The company entered into an asset purchase agreement to acquire the Paladin business for $100,000, with an additional $20,000 for inventory, and potential future payments of up to $15,000 based on sales milestones [7][36] - A working capital line of credit of USD 40,000 was obtained from Citibank, with USD 35,000 withdrawn [6][37] - The company in-licensed Onicit IV for distribution in Mexico, Brazil, and select LATAM countries, and submitted Tavalisse for ANMAT approval in Argentina [8][33][35] Shareholder Updates - Shareholders re-elected members to the Board of Directors, including Jonathan Ross Goodman and Samira Sakhia [9] Financial Outlook - The company reaffirmed its financial guidance for 2025, expecting revenues between $390 million to $405 million and adjusted EBITDA to be approximately 13% of revenues [38]
Rigel(RIGL) - 2025 Q1 - Earnings Call Transcript
2025-05-06 21:32
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]
Rigel Reports First Quarter 2025 Financial Results and Provides Business Update
Prnewswire· 2025-05-06 20:01
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 ...
Rigel Announces Settlement Agreement Resolving TAVALISSE® (fostamatinib disodium hexahydrate) Patent Litigation
Prnewswire· 2025-03-27 12:05
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]