Rigel(RIGL)

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Rigel(RIGL) - 2021 Q2 - Earnings Call Presentation
2021-08-04 04:38
August 3, 2021 Q2 2021 Financial Presentation Forward-Looking Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1955 ("PSLRA") relating to, among other things, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; Rigel's submission of an EUA application for fostamatinib for the treatment of hospitalized COVID-19 patients the commercial availability of fostamatinib; the three ongoing clinical studies on fos ...
Rigel(RIGL) - 2021 Q2 - Earnings Call Transcript
2021-08-04 03:36
Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q2 2021 Results Earnings Conference Call August 3, 2021 4:30 PM ET Company Participants Dolly Vance - Executive Vice President, Corporate Affairs and General Counsel Raul Rodriguez - President and Chief Executive Officer Wolfgang Dummer - Executive Vice President and Chief Medical Officer Dave Santos - Chief Commercial Officer Dean Schorno - Executive Vice President and Chief Financial Officer Conference Call Participants Yigal Nochomovitz - Citigroup Nicole Gabresk ...
Rigel(RIGL) - 2021 Q2 - Quarterly Report
2021-08-03 20:03
Sales Performance - TAVALISSE net product sales reached $29.4 million in the first half of 2021, a 6% increase compared to the same period in 2020, driven by increased quantities sold and price per bottle [139]. - Product sales of TAVALISSE increased by 14% to $17.1 million for the three months ended June 30, 2021, compared to $15.0 million in 2020 [211]. - Total revenues for the three months ended June 30, 2021, were $26.3 million, a 64% increase from $16.0 million in the same period of 2020 [211]. - Contract revenues from collaborations reached $3.7 million for the three months ended June 30, 2021, up from $1.0 million in the same period of 2020 [212]. - Government contract revenue was $5.5 million for the three months ended June 30, 2021, related to a $16.5 million award from the U.S. Department of Defense [214]. Clinical Trials and Research - Fostamatinib is being studied in multiple Phase 3 trials, including for warm autoimmune hemolytic anemia and hospitalized high-risk patients with COVID-19, with positive topline results reported in April 2021 [137][146]. - A post-hoc analysis of TAVALISSE in adult patients with chronic immune thrombocytopenia (cITP) showed a 78% response rate when used as a second-line therapy [141]. - Fostamatinib has been selected for the NIH ACTIV-4 trial, evaluating its efficacy in hospitalized COVID-19 patients, targeting 308 participants [147]. - The ACTIV-4 Host Tissue trial is evaluating fostamatinib in hospitalized patients with COVID-19, with approximately 150 of the targeted 308 patients enrolled as of August 2021 [192]. - R835, an orally administered IRAK1/4 inhibitor, is advancing through clinical trials with positive tolerability and pharmacokinetic data established in a Phase 1 trial [201]. - The investigational AXL inhibitor BGB324 is being investigated in two Phase 2 clinical trials for hospitalized COVID-19 patients and ongoing oncology indications [204]. Financial Overview - Research and development expenses increased to $16.8 million for the three months ended June 30, 2021, compared to $14.2 million in 2020, primarily due to ongoing clinical trials [217]. - The company anticipates an increase in research and development expenses for the remainder of 2021 due to ongoing clinical trials for COVID-19 and warm AIHA [221]. - Selling, general and administrative expenses for the three months ended June 30, 2021 were $22.4 million, an increase of $3.5 million from $18.9 million in the same period of 2020 [231]. - The company expects selling, general and administrative expenses to increase for the remainder of 2021 as it expands commercial activities [233]. - As of June 30, 2021, the company had approximately $153.4 million in cash, cash equivalents, and short-term investments, an increase of approximately $96.1 million from $57.3 million as of December 31, 2020 [242]. Strategic Partnerships and Agreements - The company entered a global exclusive license agreement with Lilly in February 2021 for the development and commercialization of R552, a RIP1 inhibitor, with an upfront cash payment of $125 million and potential milestone payments totaling $585 million [145]. - The company is responsible for 20% of development costs for R552 in the U.S., Europe, and Japan, with a maximum funding commitment of $65 million [144]. - The company received an upfront cash payment of $30 million from Grifols and is eligible for up to $297.5 million in regulatory and commercial milestones for fostamatinib in Europe and Turkey [173]. - The company received an upfront payment of $5 million from Medison for commercialization rights in Canada and Israel, with potential regulatory and commercial milestones of approximately $35 million [178]. Impact of COVID-19 - The ongoing COVID-19 pandemic has impacted patient-doctor interactions, but the company has adapted by increasing virtual engagements and plans to continue both virtual and in-person initiatives [151]. - The company has observed a reduction in patient-doctor interactions due to COVID-19, which has negatively affected product sales growth [151]. - The company continues to monitor the impact of COVID-19 on its business and has implemented safety measures to protect staff and stakeholders [150]. - The ongoing COVID-19 pandemic may adversely impact the company's ability to raise additional capital due to disruptions in global financial markets [255]. - Insufficient funds may require the company to delay or eliminate commercial efforts and research or development programs [257]. Future Outlook - Future funding requirements will depend on various factors, including the ongoing costs to commercialize TAVALISSE and the progress of clinical trials [256]. - The company anticipates opportunistically financing future cash needs through public/private offerings, debt financings, and collaboration arrangements [255]. - The company expects to receive approximately $7.4 million in future sublease income through January 2023 [254]. - The company has contractual commitments totaling $39.7 million related to facilities lease and credit facility obligations, with $11.7 million due within one year [262].
Rigel Pharmaceuticals (RIGL) EHA Investor Presentations - Slideshow
2021-06-18 22:12
June 2021 Corporate Presentation Forward-Looking Statement This presentation contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; Rigel's intention to apply for EUA for fostamatinib for the treatment of hospitalized COVID-19 patients; Rigel's ability to achieve development, regulatory and commercial milestone payments, as well as tiered royalties; expectations related to the market opportunity for fostamatinib as a COVID ...
Rigel(RIGL) - 2021 Q1 - Earnings Call Transcript
2021-05-06 02:49
Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q1 2021 Earnings Conference Call May 5, 2021 4:30 PM ET Company Participants Dolly Vance - Executive Vice President, Corporate Affairs and General Counsel Raul Rodriguez - President and Chief Executive Officer Dave Santos - Chief Commercial Officer Wolfgang Dummer - Executive Vice President and Chief Medical Officer Dean Schorno - Executive Vice President and Chief Financial Officer Conference Call Participants Yigal Nochomovitz - Citigroup Eun Yang - Jefferies Do K ...
Rigel(RIGL) - 2021 Q1 - Earnings Call Presentation
2021-05-05 22:11
May 2021 Q1 2021 Financial Presentation Forward-Looking Statement This presentation contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; Rigel's intention to apply for EUA for fostamatinib for the treatment of hospitalized COVID-19 patients; Rigel's ability to achieve development, regulatory and commercial milestone payments, as well as tiered royalties; expectations related to the market opportunity for fostamatinib as ...
Rigel(RIGL) - 2021 Q1 - Quarterly Report
2021-05-05 20:02
Financial Performance - TAVALISSE net product sales for Q1 2021 were $12.4 million, a decrease of 2% compared to Q1 2020, impacted by COVID-19 and reimbursement issues[137] - Total revenues for the three months ended March 31, 2021, were $81.0 million, an increase of 45.3% compared to $55.8 million in the same period in 2020[217] - Product sales decreased by 2% to $12.4 million in Q1 2021 from $12.7 million in Q1 2020, primarily due to the impacts of the COVID-19 pandemic[217] - Contract revenues from collaborations increased by 52.4% to $65.6 million in Q1 2021, compared to $43.1 million in Q1 2020[218] - Government contract revenue of $3.0 million was recognized from a $16.5 million award for a Phase 3 clinical trial related to COVID-19[219] Clinical Trials and Research - A post-hoc analysis showed a 78% response rate for TAVALISSE as a second-line therapy in chronic immune thrombocytopenia (cITP) patients[139] - A Phase 2 clinical trial for fostamatinib in hospitalized COVID-19 patients met its primary endpoint, showing comparable safety to standard care and improvements in efficacy endpoints[145] - Fostamatinib is currently being studied in multiple clinical trials, including a Phase 3 trial for warm autoimmune hemolytic anemia and a Phase 3 trial for COVID-19[135] - The Phase 2 trial for fostamatinib in warm AIHA showed that 44% (11/25) of evaluable patients met the primary efficacy endpoint of a hemoglobin level >10 g/dL by week 24[176] - The FORWARD study for warm AIHA has enrolled 72 out of the targeted 90 patients, with over 90 clinical trial sites established across 22 countries[178] Partnerships and Licensing - In February 2021, the company entered a global exclusive license agreement with Lilly for the development of R552, with an upfront payment of $125 million and potential milestone payments totaling $585 million[144] - The company received an upfront cash payment of $30 million from Grifols for the commercialization license of fostamatinib, with potential regulatory and commercial milestones of up to $297.5 million[168] - In Japan, Kissei received an upfront payment of $33 million for the exclusive rights to fostamatinib, with potential additional milestone payments of $147 million[171] - The company is responsible for funding development costs for R552 up to $65.0 million through April 1, 2024, under a global exclusive license agreement with Lilly[265] Expenses and Financial Outlook - Research and development expenses rose to $16.8 million in Q1 2021, up from $16.1 million in Q1 2020, driven by increased costs for ongoing clinical trials[222] - Selling, general and administrative expenses increased by 20% to $22.1 million in Q1 2021, compared to $18.4 million in Q1 2020[235] - The company anticipates continued increases in research and development expenses in 2021 due to ongoing clinical trials and new patient enrollments[224] - Selling, general and administrative expenses are expected to increase in 2021 due to the expansion of commercial activities for TAVALISSE, with ongoing virtual engagements with healthcare providers due to COVID-19 limitations[236] Cash Flow and Financial Position - As of March 31, 2021, the company had approximately $39.3 million in cash, cash equivalents, and short-term investments, a decrease of approximately $18.0 million from $57.3 million as of December 31, 2020[244] - Net cash used in operating activities was approximately $20.0 million for the three months ended March 31, 2021, compared to $3.1 million for the same period in 2020, primarily due to research and development payments[258] - Net cash provided by investing activities was approximately $7.5 million for the three months ended March 31, 2021, compared to net cash used of approximately $24.4 million in the same period in 2020[259] - The principal term loan outstanding with MidCap amounted to $20.0 million as of March 31, 2021, with access to an additional $40.0 million subject to certain conditions[249] - The company expects existing capital resources to support current and projected funding requirements for at least the next 12 months, but future funding needs will depend on various factors including commercialization costs and clinical trial progress[251] Market and Competitive Landscape - The chronic ITP market in the U.S. is estimated to affect 81,300 adult patients, highlighting the potential for TAVALISSE in this patient population[149] - The competitive landscape for TAVALISSE includes existing therapies and drug candidates targeting ITP, with corticosteroids remaining the most common first-line therapy[160][161] Safety and Efficacy - In a Phase 2 clinical trial, fostamatinib reduced the incidence of serious adverse events (SAEs) by 50%, with three SAEs in the fostamatinib group compared to six in the placebo group[183] - At Day 29, there were zero deaths in the fostamatinib group of 30 patients compared to three deaths in the placebo group of 29 patients, showing a significant difference in severe cases[184] - The median number of days in the ICU was reduced from 7 days in the placebo group to 3 days in the fostamatinib group, indicating a potential improvement in patient outcomes[184] - Fostamatinib demonstrated a mean change in clinical status improvement of -3.6 by day 15 compared to -2.6 in the placebo group, with statistical significance (p=0.035)[184]
Rigel(RIGL) - 2020 Q4 - Earnings Call Presentation
2021-03-03 12:29
| --- | --- | --- | |-------------------------|-------|-------| | | | | | | | | | | | | | | | | | Q4 and YE '20 Financial | | | | March 2021 Presentation | | | | | | | Forward-Looking Statement This presentation contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; Rigel's ability to achieve development, regulatory and commercial milestone payments; as well as tiered royalties; Rigel's expected operating results for the y ...
Rigel(RIGL) - 2020 Q4 - Earnings Call Transcript
2021-03-03 05:12
Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q4 2020 Earnings Conference Call March 2, 2021 4:30 PM ET Company Participants Dolly Vance – Executive Vice President-Corporate Affairs and General Counsel Raul Rodriguez – President and Chief Executive Officer Dave Santos – Chief Commercial Officer Wolfgang Dummer – Executive Vice President and Chief Medical Officer Esteban Masuda – Executive Vice President-Research Dean Schorno – Executive Vice President and Chief Financial Officer Conference Call Participants Yig ...
Rigel(RIGL) - 2020 Q4 - Annual Report
2021-03-02 21:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 000-29889 RIGEL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or or ...