LQDA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• daily with a short-duration next-generation nebulizer. L606 is currently being evaluated in an open-label study in the United States for treatment of PAH and PH-ILD, and we have initiated a worldwide, placebo-controlled pivotal study for the treatment of PH-ILD. We are also planning to conduct clini…

• subcutaneous administration of Treprostinil Injection will continue to be constrained. Revenue will continue to be impacted unless and until alternative pumps are available.

• Cost of product sales includes direct and indirect costs related to the manufacturing of inventory products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with manufacturing and net sales-based royalty e…

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

• The following table summarizes our results of operations (in thousands, except for percentages):

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• formulation of treprostinil, which we licensed from Pharmosa Biopharm Inc. (“Pharmosa”), that is administered twice-daily with a short-duration next-generation nebulizer. L606 is currently being evaluated in an open-label study in the United States for treatment of PAH and PH-ILD with a planned pivo…

• On October 27, 2025, we entered into an exclusive licensing agreement (the “ Vectura License Agreement”) with Vectura Limited, which provided for, among other things, (i) the exclusive right for us to develop, manufacture and commercialize for use in the United States (the “Territory”) products cont…

• Under the Vectura License Agreement, we will pay Vectura (i) an upfront payment of $2.0 million, (ii) certain development milestone payments of up to $12.0 million; (iii) certain sales milestone payments of up to $92.5 million tied to commercial sales in the Territory and (iv) royalty payments with …

• Cost of product sales includes direct and indirect costs related to the manufacturing of inventory products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with manufacturing and net sales-based royalty e…

• costs include bona fide service fees related to distribution of YUTREPIA and the cost of certain patient support programs.

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in con…

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• ●We may be unable to manufacture sufficient quantities of our products to meet future commercial demand.

• product candidates. Results of previous clinical trials or interim results of ongoing clinical trials may not be predictive of future results.

• ●A significant portion of our accounts receivable are concentrated with a limited number of customers and our inability to collect accounts receivables from our customers may adversely affect our business, results of operation and cash flows.

• Although we achieved profitability in the third and fourth quarters of 2025 and first quarter of 2026 and had positive cash flows in the fourth quarter of 2025 and first quarter of 2026, our ability to maintain profitability and positive operating cash flows in the future remains uncertain. We have …

• Our ability to sustain profitability and positive cash flows will be affected by, among other factors, the timing and magnitude of our expenses, including payments related to the HCR Agreement and expenses related to our planned clinical studies and planned clinical studies. Since our incorporation,…

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• YUTREPIA for one or both such indications, result in substantial damage claims against us if we are found to infringe any patents or to have misappropriated trade secrets, or result in United Therapeutics owning an interest in a portion of our intellectual property.

• ●We may be unable to manufacture sufficient quantities of our products to meet commercial demand.

• We have incurred net losses of $83.5 million during the nine months ended September 30, 2025, and $128.3 million and $78.5 million during the years ended December 31, 2024 and 2023, respectively. We also had negative operating cash flows for each of these periods. As of September 30, 2025, we had an…

• Since our incorporation, we have invested heavily in the development of our products and product candidates and technologies, as well as in recruiting management and scientific personnel. We have only recently started

• commercialization of YUTREPIA and most of our revenue prior to commercialization of YUTREPIA was derived from up-front fees and milestone payments made to us in connection with licensing and collaboration arrangements we have entered into and the Promotion Agreement, under which we share in the prof…

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• Scheduled Expiration Date of Rule 10b5-1 Trading Arrangement

• (1)Date of adoption of Rule 10b5-1 trading arrangements is in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations.

• (2)The first trade pursuant to the Rule 10b5-1 trading arrangement will be, in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations, on a date after the date of adoption of the Rule 10b5-1 trading arrangement.

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• During the three months ended September 30, 2025, the Company did not adopt, modify, or terminate a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) for the purchase or sale of securities of the Company, whether or not intended to satisfy the affirmative defense co…