When a label costs you $4bn in market cap

{"text":[[{"start":6.35,"text":"Baseball might be America’s pastime, but sodium is its true love."}],[{"start":11.7,"text":"While too much of the former can result in an obsession with Sabermetrics, or a sore elbow, a side effect of excessive salt consumption is high blood pressure. An estimated more than 100mn Americans are afflicted."}],[{"start":25.549999999999997,"text":"One North Carolina-based drug company, Liquidia, has gone gangbusters over the past year in an effort to address a specific form of this condition: pulmonary hypertension."}],[{"start":37,"text":"The company sells the drug treprostinil under the brand name Yutrepia. This is an inhaled dry powder used to treat two types of pulmonary hypertension: pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). "}],[{"start":55.25,"text":"Liquidia’s revenues surged following Yutrepia’s launch in June 2025 (a month after it got FDA approval): up from $12mn in the first six months of 2025 on an $80mn loss, to $304mn in the same period this year on a $127mn profit. "}],[{"start":74.9,"text":"Shares duly did their thing:"}],[{"start":null,"text":"

"}],[{"start":76.9,"text":"All this success appears to have set blood boiling at United Therapeutics, Liquidia’s larger rival. "}],[{"start":83.60000000000001,"text":"United’s brand is Tyvaso, a nebulised version of which was first approved in 2009 for PAH and for PH-ILD in 2021. It launched Tyvaso DPI, a dry-powder model, in 2022. "}],[{"start":99.2,"text":"United’s patent covering the treatment of PH-ILD via inhaled treprostinil is number 11,826,327 and runs to February 2042."}],[{"start":112.10000000000001,"text":"In July 2023, Liquidia sought approval from the FDA to use Yutrepia for PH-ILD on top of PAH and notified United of a challenge to its patents."}],[{"start":124.65,"text":"United sued. In federal court in Delaware in September of that year, United accused Liquidia of infringement of a different patent, number 10,716,793. This, however, had previously been deemed “unpatentable” by the US Patent and Trademark Office in 2022, a ruling later upheld on appeal in December 2023."}],[{"start":147.05,"text":"In the meantime, United received patent 11,826,327 on November 28 2023. Two days later, it included it in an amended complaint and in January 2024 withdrew patent ’793."}],[{"start":163.85000000000002,"text":"The trial was held over four days in June 2025, by which point the focus had narrowed to six claims. "}],[{"start":170.95000000000002,"text":"Last Wednesday, Judge Richard G Andrews issued his opinion, all 55 pages of which are here for your delectation. "}],[{"start":178.00000000000003,"text":"At the heart of United’s claim was that Liquidia had encroached on its territory by issuing an FDA-approved label on Yutrepia — one that told doctors to use the drug to treat PH-ILD with inhaled treprostinil at specific doses, which United said was covered by patent ’327. "}],[{"start":198.10000000000002,"text":"Liquidia had conceded that Yutrepia infringed two of the claims — 1 and 14 — under the patent but sought to claim that they were nonetheless invalid. Judge Andrews disagreed, and Liquidia was ruled to have infringed the patent. The other four claims were in effect deemed to be incidental to claim 1. "}],[{"start":216.90000000000003,"text":"The patent infringement means Liquidia, at worst, could be forced to pay damages and temporarily take Yutrepia off the market altogether while it gets a new label without PH-ILD approved by the FDA. "}],[{"start":230.55000000000004,"text":"Shares duly did their thing:"}],[{"start":null,"text":""}],[{"start":232.55000000000004,"text":"That’s one expensive labelling “issue”. Circa $2bn of market value apiece for an extra “L” and “D”."}],[{"start":239.65000000000003,"text":"Investors to have had almost two-thirds of their gains wiped out include Tom Steyer’s Farallon Capital — he of I am a billionaire and I believe I shouldn’t exist “fame”. "}],[{"start":251.10000000000002,"text":"On the flip side, United’s shareholders seem pretty chuffed."}],[{"start":null,"text":""}],[{"start":254.60000000000002,"text":"The two sides need to agree a remedy on the labelling by Wednesday at the latest. If they can’t reach a deal, the Court will step back in. "}],[{"start":262.90000000000003,"text":"Liquidia plans to quickly “skinny” its label by removing PH-ILD and keeping the drug on the market to treat PAH. It has suggested it may appeal against the ruling. The company declined to comment further."}],[{"start":273.65000000000003,"text":"United — which is a public benefit corporation — wants the FDA to withdraw the entire approval for Yutrepia for both PH-ILD and PAH while it approves new labelling without PH-ILD, de facto removing Liquidia’s product from the US market until the new label is ready. They also plan to seek damages for past infringement, likely through royalties on historic sales. Investors in Liquidia expect litigation about the latter to be drawn out. "}],[{"start":302.35,"text":"An investor in Liquidia told FTAV that if United goes ahead with this request, “thousands of patients — including patients for the non-infringing treatment of PAH — will be denied a life-saving treatment while the FDA considers the matter”."}],[{"start":316.70000000000005,"text":"United’s COO Michael Benkowitz said in a press release last Wednesday: "}],[{"start":321.15000000000003,"text":"Our immediate priority is ensuring that no patient goes without the therapy they need, and we are ready to support a seamless transition to Tyvaso or Tyvaso DPI should PH-ILD be removed from the Yutrepia label."}],[{"start":334.25000000000006,"text":"Meanwhile Liquidia has warned “it is not possible at this time to reasonably estimate the range of potential outcomes or financial exposure”."}],[{"start":342.75000000000006,"text":"United told FTAV its “highest priority” remained the care and continuity of therapy for all patients with PAH and PH-ILD. "}],[{"start":352.65000000000003,"text":"The company added that it had “established programs to help ensure that eligible patients can quickly and seamlessly transition” to its products “without interruption or increased cost”."}],[{"start":363.00000000000006,"text":"Some investors clearly aren’t waiting around based on the stock unwind, while others have made up their mind on how they think things will go later this week:"}],[{"start":null,"text":""}],[{"start":371.55000000000007,"text":" Not everyone is worried though. "}],[{"start":381.3500000000001,"text":""}]],"url":"https://audio.ftcn.net.cn/album/a_1791261599_8146.mp3"}