AUPH 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• For the three months ended March 31, 2026, net product sales of LUPKYNIS were $73.6 million, up 23%, from $60.0 million, in the same period of 2025.

• For the three months ended March 31, 2026, cash flows from operating activities were $32.6 million, up 2408% from $1.3 million in the same period of 2025.

• As of March 31, 2026, Aurinia had cash, cash equivalents, restricted cash and investments of $378.8 million, compared to $398.0 million at December 31, 2025. For the three months ended March 31, 2026, cash outflows from financing activities were $53.7 million, which included the repurchase of 2.5 mi…

• Comparison of the Three Months ended March 31, 2026 and 2025

• The following table sets forth our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• On June 30, 2025, Aurinia announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept. The Company plans to initiate clinical studies with aritinercept in two autoimmune diseases by the end of 2025.

• For the three and nine months ended September 30, 2025, net product sales were $70.6 million and $197.2 million, up 27% and 24%, respectively, from $55.5 million and $158.6 million, respectively, for the same periods in 2024.

• For the nine months ended September 30, 2025, cash flows from operating activities were $90.0 million, compared to $14.3 million for the same period of 2024. Excluding $11.6 million of cash payments made in connection with the November 2024 restructuring, cash flows from operating activities were $1…

• As of September 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $351.8 million compared to $358.5 million at December 31, 2024. For the nine months ended September 30, 2025, the Company repurchased 12.2 million of its common shares for $98.2 million.

• Comparison of the Three and Nine Months ended September 30, 2025 and 2024

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• There are no material developments to report in respect of the legal proceedings described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• On November 2, 2025, the Company and its wholly-owned subsidiary, Aurinia Pharma U.S., Inc., filed a complaint alleging defamation and injurious falsehood against Dr. George Tidmarsh in the United States District Court for the District of Maryland. The complaint alleges that Dr. Tidmarsh personally …

• In February and March 2025, the Company received a paragraph IV notice of certification (the “Notice Letter”) from each of Hikma Pharmaceuticals USA Inc., Lotus Pharmaceutical Co. Ltd., Galenicum Health S.L.U., Zydus Pharmaceuticals (USA) Inc., Teva Pharmaceuticals, Inc., Dr. Reddy's Laboratories, I…

• The Company filed complaints for patent infringement against each of Hikma Pharmaceuticals USA Inc. (filed April 10, 2025); Lotus Pharmaceutical Co. Ltd. (filed April 11, 2025); Galenicum Health S.L.U. (filed April 17, 2025); Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Ltd. (filed April …

• In accordance with the Hatch-Waxman Act, because LUPKYNIS is a New Chemical Entity and the Company filed a complaint for patent infringement within 45 days of the receipt of each Notice Letter, the FDA cannot approve the ANDAs for these applications any earlier than 7.5 years from the approval of th…

• The Company intends to vigorously enforce its intellectual property rights relating to LUPKYNIS.