Rigel(RIGL)

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Rigel(RIGL) - 2024 Q2 - Earnings Call Transcript
2024-08-09 18:12
Financial Data and Key Metrics - Net product sales for Q2 2024 were $33.5 million, a 40% increase compared to $23.9 million in Q2 2023 [6] - TAVALISSE net product sales reached $26.4 million in Q2 2024, a 24% increase from Q1 2024 and 25% growth year-over-year [10] - REZLIDHIA net product sales were $5.2 million in Q2 2024, doubling compared to $2.6 million in Q2 2023 [12] - GAVRETO contributed $1.9 million in net product sales in Q2 2024, with 228 bottles shipped to stock the distribution channel [17][18] - Total cost and expenses for Q2 2024 were $36.4 million, up from $32.2 million in Q2 2023, driven by higher product sales costs and R&D expenses [32] Business Line Performance - TAVALISSE achieved its seventh consecutive quarterly record, with 2,672 bottles shipped to patients and clinics, an 8% increase from Q1 2024 and 18% growth year-over-year [10] - REZLIDHIA shipped 424 bottles to patients and clinics in Q2 2024, a 30% increase from Q1 2024 and more than double the demand from Q2 2023 [11] - GAVRETO became commercially available on June 27, 2024, with a smooth transition and early shipments contributing to Q2 revenue [15][17] Market and Strategic Developments - GAVRETO, an FDA-approved therapy for RET fusion-positive cancers, was added to the portfolio, leveraging existing commercial and medical expertise [4][5] - Strategic collaborations with MD Anderson Cancer Center and CONNECT aim to explore REZLIDHIA in IDH1-mutant cancers and advance olutasidenib in AML and glioma [6][19][23] - The company is progressing with its IRAK1/4 inhibitor R289 in a phase 1b trial for lower-risk MDS, with preliminary data expected by the end of 2024 [6][27] Management Commentary - The company is approaching net income break-even, driven by record sales and financial discipline [6][33] - Management highlighted the potential for future growth through in-licensing deals and acquisitions, similar to REZLIDHIA and GAVRETO [33][46] - The focus remains on expanding the hematology and oncology portfolio, with ongoing clinical trials and strategic partnerships [19][23] Q&A Session Question: IRAK1/4 Dose Escalation - The addition of twice-daily dosing cohorts for R289 was based on emerging data to explore optimal dosing for phase 2 expansion [36] Question: MD Anderson Collaboration - The goal is to evaluate olutasidenib in combination with other agents for IDH1-mutated AML, potentially leading to an all-oral triplet therapy [38][39] Question: Revenue Guidance - Management is evaluating the possibility of providing revenue guidance in the future as the business solidifies and approaches break-even [40][41] Question: TAVALISSE Growth Drivers - Growth in TAVALISSE sales is driven by new patient starts and increased prescriber adoption, including earlier-line usage [43][44] Question: Future Deals and Financial Discipline - The company plans to pursue deals that leverage existing capabilities and provide near-term market entry, similar to REZLIDHIA and GAVRETO [46][47] Question: Impact of Voracitinib Approval - The FDA approval of voracitinib for glioma validates the role of IDH inhibitors, with olutasidenib positioned in a different treatment setting [52][53]
Rigel Pharmaceuticals (RIGL) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-06 22:32
Rigel Pharmaceuticals (RIGL) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.37. This compares to loss of $0.40 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 83.78%. A quarter ago, it was expected that this drug developer would post a loss of $0.30 per share when it actually produced a loss of $0.50, delivering a surprise of -66.67%. Over the last four quarters, the comp ...
Rigel(RIGL) - 2024 Q2 - Quarterly Results
2024-08-06 20:11
Exhibit 99.1 Rigel Reports Second Quarter 2024 Financial Results and Provides Business Update · Second quarter total revenue of $36.8 million, which includes TAVALISSE net product sales of $26.4 million, REZLIDHIA net product sales of $5.2 million and GAVRETOnet product sales of $1.9 million · Successfully completed NDA transfer of GAVRETO for the treatment of RET fusion-positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer, with product available from Rigel beginning June ...
Rigel(RIGL) - 2024 Q2 - Quarterly Report
2024-08-06 20:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 JUNE 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 0-29889 Rigel Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 94-3248524 (Sta ...
Rigel Announces Conference Call and Webcast to Report Second Quarter 2024 Financial Results and Business Update
Prnewswire· 2024-07-30 12:05
Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website. Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing n ...
Rigel Pharmaceuticals: Undervalued FDA-Approved Products With Promising Cash Flow Potential
Seeking Alpha· 2024-07-24 07:06
Source : Mordor Intelligence Product Pipeline: Progress and Updates ■ TAVALISSE PHASE 1 Lower-Risk Myelodysplastic Syndrome Target: Interleukin receptor-associated kinases 1 and 4 (IRAK1/4) NSCLC Target: AXL receptor tyrosine kinase (AXL) Milademetan' - Daiichi Sankyo CNS Diseases Target: RIPK1 PRE-CLINICAL PRE-CL In 2023, Gavreto generated around $28 million in revenues from the US alone. Its action mechanism inhibits RET kinase activity by binding to it, blocking signaling pathways essential for cancer ce ...
Rigel Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)
Prnewswire· 2024-07-12 12:05
SOUTH SAN FRANCISCO, Calif., July 12, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. ("Rigel") (Nasdaq: RIGL) today announced that it has granted awards pursuant to Rigel's Inducement Plan, approved by the Compensation Committee of Rigel's Board of Directors and granted as an inducement material to employees' entering into employment with Rigel, in accordance with NASDAQ Listing Rule 5635(c)(4). Specifically, Rigel granted 79,890 stock options to eleven non-executive employees vesting over four years with ...
Rigel Announces Reverse Stock Split
Prnewswire· 2024-06-25 12:00
The Reverse Stock Split was approved by the company's stockholders at its Annual Meeting of Stockholders held on May 24, 2024 to be effected by the company's Board of Directors (the "Board") within approved parameters. The final ratio was approved by the Board on June 15, 2024. As a result of the Reverse Stock Split, every 10 shares of the company's pre-split common stock issued and outstanding will be automatically reclassified into one new share of the company's common stock. This will reduce the number o ...
Rigel Pharmaceuticals Completes Transfer of GAVRETO® (pralsetinib) New Drug Application
Prnewswire· 2024-06-24 20:05
GAVRETO will be available from Rigel in the U.S. beginning June 27, 2024 SOUTH SAN FRANCISCO, Calif., June 24, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. ("Rigel") (Nasdaq: RIGL) today announced the completion of the transfer to Rigel of the New Drug Application (NDA) for GAVRETO® (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by a U.S. Food and Drug Administration (FDA) approved test ...
Rigel Announces Five Presentations at the EHA2024 Hybrid Congress
Prnewswire· 2024-06-14 07:05
- Oral presentation highlighting final five-year efficacy data from the registrational Phase 2 trial of REZLIDHIA® (olutasidenib) in heavily pretreated patients with R/R mIDH1 AML, including those receiving prior venetoclax - New data shows clinically meaningful effect of olutasidenib in patients with mIDH1 AML secondary to MPN and as bridge-to-transplant treatment in patients with R/R mIDH1 AML SOUTH SAN FRANCISCO, Calif., June 14, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today annou ...