Liquidia (NASDAQ:LQDA) reported a 31% sequential increase in third-quarter YUTREPIA sales as the company sought to reassure investors that its pulmonary arterial hypertension business can continue growing following a patent settlement with United Therapeutics.
YUTREPIA net product sales rose to $222.7 million from the second quarter, including $212.2 million in paid patient demand sales. Liquidia reported a $236.3 million net loss under generally accepted accounting principles, reflecting a $389.7 million one-time settlement charge.
Chief Executive Officer Roger Jeffs said the settlement ended litigation uncertainty surrounding YUTREPIA and that the company would focus on its business and development pipeline. The drug is indicated for pulmonary arterial hypertension, or PAH, while patients already receiving it for pulmonary hypertension associated with interstitial lung disease, known as PH-ILD, are not required by the settlement to switch treatments, he said.
Referrals and Prescribing After Settlement
Jeffs said more than 60% of YUTREPIA prescriptions from launch through September included a PAH diagnosis, rising to more than 70% in September. Total monthly shipments to patients reached their highest level since launch in October, the first full month after the recent court ruling, he said.
New referrals held up despite uncertainty, Jeffs said. The daily referral rate in October was more than 75% of the third-quarter daily rate. He attributed a pause at some treatment centers partly to a competitor’s letter to health care providers following the ruling and said he expects referrals to recover after Liquidia communicated with prescribers about the settlement.
Liquidia had approximately 1,300 YUTREPIA prescribers. Roughly 60% had prescribed the drug for at least two patients, and more than 30% had prescribed it for at least five, Jeffs said. He added that conversion rates remained above 87%, with no change in formulary status or coverage.
Chief Commercial Officer Scott Moomaw said the physician attestation required under the settlement takes the form of a checkbox on the prescription intake form. Chief Operating Officer and Chief Financial Officer Michael Kaseta said the company did not expect changes to patient reauthorizations, although he acknowledged a limited impact was theoretically possible.
Settlement Charge and Financial Outlook
Of the $389.7 million settlement charge, $380.7 million is payable in cash through April 2027, Kaseta said. Liquidia ended the third quarter with $396.1 million in cash and cash equivalents before the settlement payments, up $111.9 million from the prior quarter.
Adjusted earnings before interest, taxes, depreciation and amortization, a non-GAAP measure, rose to $140.5 million, marking a fifth consecutive quarterly increase. Gross margin was approximately 94%, similar to the second quarter. Research and development expenses rose 47% sequentially to $25.3 million as enrollment increased in the RE-SPIRE study and new YUTREPIA studies began.
Kaseta said Liquidia does not need to raise capital and is not changing its operating plan. He said there would be no royalties or ongoing payments to United Therapeutics after the final settlement payment.
Asked about an earlier settlement proposal, Jeffs said United Therapeutics had sought 100% of PH-ILD revenue through 2042 and 50% of PAH revenue. He characterized the offer as unreasonable. The call did not include a response from United Therapeutics.
Kaseta said Liquidia wanted more data before issuing 2027 revenue guidance and expected to provide more information in early January, when the company also plans to share fourth-quarter results.
Clinical Development Plans
Liquidia plans to continue studies of YUTREPIA dosing flexibility in PAH. Chief Medical Officer Rajeev Saggar said the open-label SPRINT study, expected to initiate at the end of 2026, will compare three-times-daily and four-times-daily dosing and aims to measure a 20% to 25% reduction in pulmonary vascular resistance. The company also plans to launch a real-world PAH registry called EASY-PAH in 2027.
For L606, an extended-release liposomal formulation of treprostinil delivered by nebulizer, the global pivotal RE-SPIRE study in PH-ILD is expected to complete enrollment in 2028. A separate pivotal PAH study, AMPLIFY-PAH, is planned to start in 2027. Jeffs said the studies are expected to support a regulatory submission in 2029.
Liquidia also plans a pivotal L606 study in pulmonary hypertension associated with chronic obstructive pulmonary disease in the second half of 2027. Saggar said the company believes the formulation could reduce upper respiratory irritation, while noting that an earlier study of another inhaled treprostinil product in that population was stopped for safety reasons.
Separately, Liquidia is enrolling patients in RE-WARM, a YUTREPIA dose-finding study in systemic sclerosis associated with Raynaud’s phenomenon. Jeffs said the study is expected to finish in the first half of 2027 and, if successful, could support a pivotal study during subsequent winter seasons.
About Liquidia (NASDAQ:LQDA)
Liquidia Corporation is a biopharmaceutical company focused on developing and commercializing treatments for pulmonary hypertension and other serious diseases. Its work includes inhaled therapies designed to deliver medicines to the lungs. The company’s marketed product, Yutrepia (treprostinil) inhalation powder, is approved in the United States for adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Liquidia also has a pipeline of investigational therapies, including other formulations of treprostinil.
