Rigel(US:RIGL)2021-08-03 20:03Sales 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].