Rigel Reports Second Quarter 2022 Financial Results and Provides Business Update
August 02 2022 - 04:02PM
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Second quarter TAVALISSE® net product sales of $18.6 million and total revenues of $29.8 million
Expanded Rigel's hematology-oncology portfolio by entering into an exclusive license agreement with Forma Therapeutics, Inc. for olutasidenib with an expected launch in 2023
Enrollment completed in Rigel's pivotal Phase 3 clinical trial in high-risk patients hospitalized with COVID-19 with top-line data expected year-end
Management to host a conference call and webcast today at 4:30 p.m. Eastern Time and will be joined by Key Opinion Leader and olutasidenib Phase 2 clinical trial investigator, Jorge E. Cortes, M.D.
SOUTH SAN FRANCISCO, Calif., Aug. 2, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the second quarter ended June 30, 2022, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
"The second quarter of 2022 was a significant one for Rigel, marked by the highest quarterly net product sales for TAVALISSE in ITP since launch. We are also excited about the strategic expansion of our hematology-oncology portfolio to include olutasidenib, and the synergy it provides. We believe the addition of olutasidenib will broaden the reach of the Rigel field force by providing a potential new therapy for mIDH1 relapsed or refractory acute myeloid leukemia and other malignancies," said Raul Rodriguez, Rigel's president and CEO. "I am pleased with our progress, and believe Rigel is well-positioned to continue driving momentum for TAVALISSE in ITP and prepare for the potential launch of olutasidenib in 2023."
Business Update
In the second quarter of 2022, TAVALISSE net product sales were $18.6 million, representing the highest net product sales since launch and an increase of 9% compared to the second quarter of 2021.
Today, Rigel announced an exclusive license agreement with Forma Therapeutics, Inc. (Forma) to develop, manufacture and commercialize olutasidenib, an oral, small molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1) for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) and other malignancies. The U.S. Food and Drug Administration (FDA) has accepted Forma's New Drug Application (NDA) for olutasidenib. The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023. Olutasidenib is highly synergistic with Rigel's existing hematology-oncology focused commercial infrastructure and if approved, would be Rigel's second commercial product in this space.
On June 8, 2022, Rigel announced topline efficacy and safety data from the FORWARD Phase 3 clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel is conducting an in-depth analysis of this data to better understand differences in patient characteristics and outcomes and expects to discuss these findings with the FDA to determine the path forward in wAIHA.
In July, Rigel completed enrollment, with 280 patients, in its pivotal Phase 3 clinical trial evaluating fostamatinib in high-risk patients hospitalized with COVID-19. The trial had originally targeted a total of 308 patients; however, Rigel determined the trial would be sufficiently powered with 280 patients to potentially provide a clinically meaningful result and determine the efficacy and safety of fostamatinib in COVID-19. Rigel expects to report top-line results in Q4 2022 and if the data is positive, file an Emergency Use Authorization with the FDA.
In May, Rigel entered into a commercial license agreement with Knight Therapeutics International SA (Knight) for the commercialization of TAVALISSE in all indications in Latin America. Rigel received a $2.0 million upfront payment in the second quarter of 2022, with potential for up to an additional $20.0 million in regulatory and sales-based commercial milestone payments, and will receive twenty- to mid-thirty percent, tiered, escalated net sales-based royalty payments for products sold in the Knight territory.
In April, Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced that an NDA was submitted to Japan's Pharmaceuticals and Medical Devices Agency for fostamatinib in chronic ITP. During the second quarter, Rigel received a $5.0 million regulatory milestone in connection with the filing of the NDA.
Financial Update
For the second quarter of 2022, Rigel reported a net loss of $13.5 million, or $0.08 per basic and diluted share, compared to a net loss of $13.8 million, or $0.08 per basic and diluted share for the same period of 2021.
For the second quarter of 2022, total revenues were $29.8 million, consisting of $18.6 million in TAVALISSE net product sales and $11.3 million in contract revenues from collaborations. TAVALISSE net product sales of $18.6 million increased by 9%, compared to $17.1 million in the second quarter of 2021. Contract revenues from collaborations during the second quarter of 2022 consisted of $7.5 million in revenue from Kissei related to a milestone payment and delivery of fostamatinib supply, $2.0 million in revenue related to the license agreement with Knight, $1.4 million in revenue from Grifols related to the delivery of fostamatinib supply and performance of certain research and development services pursuant to the collaboration agreement, and $0.3 million in revenue related to the license agreement with Eli Lilly.
For the second quarter of 2022, total costs and expenses were $42.8 million, compared to $39.3 million for the same period of 2021. The increase in costs and expenses was primarily due to increased commercial activities related to the sales force expansion, and increased research and development costs for the IRAK1/4 inhibitor program, partially offset by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the ongoing Phase 3 clinical trial in high-risk hospitalized patients with COVID-19.
For the six months ended June 30, 2022, Rigel reported a net loss of $40.9 million, or $0.24 per basic and diluted share, compared to a net income of $25.7 million, or $0.15 per basic and diluted share, for the same period of 2021.
For the six months ended June 30, 2022, total revenues were $46.6 million, consisting of $34.7 million in TAVALISSE net product sales and $11.8 million in contract revenues from collaborations. TAVALISSE net product sales of $34.7 million increased by 18% compared to $29.4 million in the same period of 2021. Contract revenues from collaborations for the six months ended June 30, 2022 consisted of $7.6 million in revenue from Kissei primarily related to a milestone payment and delivery of fostamatinib supply, $2.0 million in revenue related to the license agreement with Knight, $1.7 million in revenue from Grifols related to the delivery of fostamatinib supply and performance of certain research and development services pursuant to the collaboration agreement, and $0.5 million in revenue related to the license agreement with Eli Lilly.
For the six months ended June 30, 2022, total costs and expenses were $85.8 million, compared to $78.6 million for the same period of 2021. The increase in costs and expenses was primarily due to increased commercial related activities related to the sales force expansion, and increased research and development costs for the IRAK1/4 inhibitor program, partially offset by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the ongoing Phase 3 clinical trial in high-risk hospitalized patients with COVID-19.
As of June 30, 2022, Rigel had cash, cash equivalents and short-term investments of $89.2 million, compared to $125.0 million as of December 31, 2021. In July 2022, Rigel accessed an additional $10.0 million term loan through its credit agreement with MidCap Financial Trust (MidCap) and amended the terms of the credit agreement which, among other things, allows Rigel to defer the loan principal payment by one year and extends the maturity date for the term loans.
Conference Call and Webcast Today at 4:30 p.m. Eastern Time, with Key Opinion Leader and olutasidenib Phase 2 clinical trial investigator, Jorge E. Cortes, M.D.
Rigel will host a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss financial results, and provide an update on the business, including the license agreement with Forma. The conference call will also feature a presentation of the olutasidenib Phase 2 interim results by Jorge E. Cortes, M.D., Director, Georgia Cancer Center at Augusta University, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator.
Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call 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 after the call via the Rigel website.
About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About AML
Acute myeloid leukemia (AML) is a cancer that starts in a person's bone marrow but often quickly moves into the blood. AML develops from immature blood cells, known as myeloid cells, that are supposed to mature into white blood cells. However, the diseased myeloid cells do not function properly. They instead multiply rapidly, which causes normal blood cell production to fail. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that in the United States alone, there will be about 20,050 n
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