UTHR — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• •The timing and outcome of clinical studies, other research and development efforts, and related regulatory filings and approvals, including our efforts to obtain FDA approval for Nebulized Tyvaso to treat IPF and ralinepag extended-release tablets to treat PAH;

• We settled litigation with Watson Laboratories, Inc. (Watson) related to its ANDA seeking FDA approval to market a generic version of Nebulized Tyvaso before the expiration of certain of our U.S. patents. Under the settlement, Watson was permitted to market its generic version of Nebulized Tyvaso in…

• We also settled litigation with Actavis Laboratories FL, Inc. (Actavis) and ANI Pharmaceuticals, Inc. (ANI) related to their ANDAs seeking FDA approval to market generic versions of Orenitram before the expiration of certain of our U.S. patents. Under the settlement agreements, Actavis and ANI can m…

• Currently, we grant stock options and restricted stock units under the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the 2015 Plan), and we may grant restricted stock units to newly hired employees under our 2019 Inducement Stock Incentive Plan (the 2019 Inducement …

• We focus our research and development efforts on the following pipeline programs. We also engage in a variety of additional research and development efforts, including efforts to develop new and improved devices to deliver our current commercial products and other small molecule therapies, some of w…

Text removed vs the prior filing · source: 10-Q · 2025-10-29

• •The timing and outcome of clinical studies, other research and development efforts, and related regulatory filings and approvals;

• infusion system for its generic treprostinil product. See Note 12—Litigation, to our consolidated financial statements included in this Quarterly Report on Form 10-Q.

• We settled litigation with Watson Laboratories, Inc. (Watson) and Actavis Laboratories FL, Inc. (Actavis) related to their ANDAs seeking FDA approval to market generic versions of Nebulized Tyvaso and Orenitram, respectively, before the expiration of certain of our U.S. patents. Under the settlement…

• Historically, we granted awards under our Share Tracking Awards Plan (the STAP). Issuance of awards under this plan was discontinued in 2015 and all remaining outstanding STAP awards were exercised during the first quarter of 2025. Currently, we grant stock options and restricted stock units under t…

• The fair value of stock options is measured using inputs and assumptions under the Black-Scholes-Merton model. The fair value of restricted stock units is measured using our stock price on the date of grant.

Text added vs the prior filing · source: 10-Q · 2026-05-06

• Investing in our securities involves uncertainty and risk due to a variety of factors. You should carefully consider each of the following risks and all of the other information contained in this Report and in other documents that we file with, or furnish to, the SEC before making any investment dec…

• We plan to submit an sNDA to the FDA by the end of summer 2026, seeking approval to add IPF to the labeled indications for Nebulized Tyvaso, based on the successful TETON-1 and TETON-2 results. Following any FDA approval, we then plan to submit a request to the Durable Medical Equipment Medicare Adm…

• updated, we expect revenues generated by sales of Nebulized Tyvaso for the new IPF indication could be limited, since we believe that most U.S. IPF patients are Medicare beneficiaries.

• •We and our third-party manufacturers rely upon utility companies to supply our facilities with electrical power. The U.S. power grid is aging and demand for electrical power is rapidly increasing, including as a result of the construction of data centers in certain regions. If utility companies can…

• Any of these factors could disrupt sales of our commercial products, delay clinical trials or commercialization of new products, result in product liability claims and product recalls, and entail higher costs or lost revenues. Interruptions in our

Text removed vs the prior filing · source: 10-Q · 2025-10-29

• local municipalities are unable to supply water that meets relevant quality standards, we and our third-party manufacturers may be unable to manufacture these products until such a situation is remediated.

• Any of these factors could disrupt sales of our commercial products, delay clinical trials or commercialization of new products, result in product liability claims and product recalls, and entail higher costs. Interruptions in our manufacturing process could be significant given the length of time a…

• We rely entirely on third parties to supply pumps and other supplies necessary to administer Remodulin. There are a limited number of pumps and other supplies available in the market, and the discontinuation of any particular pump could have a material, adverse impact on our Remodulin revenues if a …

• subcutaneous Remodulin, and specialty pharmacy distributors informed us that supplies of new MS-3 pumps are fully exhausted, although a limited number of refurbished pumps may be available for use with generic treprostinil. In 2022, ICU Medical discontinued manufacturing and distribution of the CADD…

• Finally, we rely entirely on Sanner GmbH (which recently acquired Gilero LLC) to manufacture cartridges that were cleared by the FDA for use with the MS-3 pump to administer Remodulin. For a further discussion of risks created by the use of third-party contract manufacturers, see the risk factor abo…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• During the three months ended March 31, 2026, no director or Section 16 officer adopted or terminated any Rule 10b5-1 plans or non-Rule 10b5-1 trading arrangements (in each case, as defined in Item 408(a) of Regulation S-K).

Text removed vs the prior filing · source: 10-Q · 2025-10-29

• On August 5, 2025, James Edgemond, a Section 16 officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) to exercise up to 129,517 stock options and sell the shares of our common stock received, subject to certain conditions.

• On August 11, 2025, Paul Mahon, a Section 16 officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) to exercise up to 196,940 stock options and sell the shares of common stock received, subject to certain conditions.

• On September 11, 2025, Jan Malcolm, a member of our Board of Directors, adopted a trading plan intended to satisfy Rule 10b5-1(c) to sell up to 720 shares of our common stock, subject to certain conditions.

• On September 30, 2025, Christopher Causey, a member of our Board of Directors, adopted a trading plan intended to satisfy Rule 10b5-1(c) to exercise up to 4,320 stock options and sell the shares of common stock received, subject to certain conditions.

• During the three months ended September 30, 2025, no director or Section 16 officer terminated any Rule 10b5-1 plans or non-Rule 10b5-1 trading arrangements (in each case, as defined in Item 408(a) of Regulation S-K).