Rigel(US:RIGL)2021-05-05 20:02Financial 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]