Liquidia Corporation Reports Full Year 2024 Financial Results and Provides Corporate Update
Liquidia (NASDAQ: LQDA) reported its full year 2024 financial results, highlighting key developments and financial performance. The company is awaiting final FDA approval for YUTREPIA™ after regulatory exclusivity expires on May 23, 2025, following its tentative approval for PAH and PH-ILD treatment in August 2024.
Financial highlights include:
- Cash position of $176.5 million as of December 31, 2024
- Revenue decreased to $14.0 million from $17.5 million in 2023
- Net loss widened to $130.4 million ($1.66 per share) from $78.5 million in 2023
The company strengthened its financial position through an amended agreement with HealthCare Royalty Partners, providing access to up to $100 million in additional financing. The ASCENT study evaluating YUTREPIA in PH-ILD patients is nearing completion, while development of L606, a twice-daily liposomal treprostinil formulation, continues to progress.
Liquidia (NASDAQ: LQDA) ha riportato i risultati finanziari per l'intero anno 2024, evidenziando sviluppi chiave e performance finanziaria. L'azienda sta aspettando l'approvazione finale della FDA per YUTREPIA™ dopo che l'esclusività regolatoria scadrà il 23 maggio 2025, a seguito dell'approvazione provvisoria per il trattamento della PAH e della PH-ILD avvenuta nell'agosto 2024.
I punti salienti finanziari includono:
- Posizione di cassa di $176,5 milioni al 31 dicembre 2024
- Ricavi diminuiti a $14,0 milioni rispetto ai $17,5 milioni del 2023
- Perdita netta aumentata a $130,4 milioni ($1,66 per azione) rispetto ai $78,5 milioni del 2023
L'azienda ha rafforzato la sua posizione finanziaria attraverso un accordo modificato con HealthCare Royalty Partners, che fornisce accesso a fino a $100 milioni di finanziamenti aggiuntivi. Lo studio ASCENT che valuta YUTREPIA nei pazienti con PH-ILD è quasi completato, mentre lo sviluppo di L606, una formulazione liposomiale di treprostinil da assumere due volte al giorno, continua a progredire.
Liquidia (NASDAQ: LQDA) informó sus resultados financieros del año completo 2024, destacando desarrollos clave y el rendimiento financiero. La empresa está esperando la aprobación final de la FDA para YUTREPIA™ después de que la exclusividad regulatoria expire el 23 de mayo de 2025, tras su aprobación provisional para el tratamiento de PAH y PH-ILD en agosto de 2024.
Los aspectos financieros destacados incluyen:
- Posición de efectivo de $176.5 millones al 31 de diciembre de 2024
- Los ingresos disminuyeron a $14.0 millones desde $17.5 millones en 2023
- La pérdida neta se amplió a $130.4 millones ($1.66 por acción) desde $78.5 millones en 2023
La empresa fortaleció su posición financiera a través de un acuerdo modificado con HealthCare Royalty Partners, proporcionando acceso a hasta $100 millones en financiamiento adicional. El estudio ASCENT que evalúa YUTREPIA en pacientes con PH-ILD está cerca de completarse, mientras que el desarrollo de L606, una formulación liposomal de treprostinil que se toma dos veces al día, continúa avanzando.
Liquidia (NASDAQ: LQDA)는 2024년 전체 연도 재무 결과를 발표하며 주요 개발 사항과 재무 성과를 강조했습니다. 이 회사는 2024년 8월 PAH 및 PH-ILD 치료를 위한 임시 승인을 받은 후, 2025년 5월 23일에 규제 독점권이 만료된 후 YUTREPIA™에 대한 최종 FDA 승인을 기다리고 있습니다.
재무 하이라이트는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 보유액 $176.5 백만
- 수익이 2023년의 $17.5 백만에서 $14.0 백만으로 감소
- 순손실이 2023년의 $78.5 백만에서 $130.4 백만 ($1.66 주당)으로 확대
회사는 HealthCare Royalty Partners와의 수정된 계약을 통해 재무 상태를 강화하여 최대 $100 백만의 추가 자금에 접근할 수 있도록 했습니다. PH-ILD 환자에서 YUTREPIA를 평가하는 ASCENT 연구가 완료에 가까워지고 있으며, 하루 두 번 복용하는 리포좀 형태의 treprostinil 제제 L606의 개발도 계속 진행되고 있습니다.
Liquidia (NASDAQ: LQDA) a publié ses résultats financiers pour l'année complète 2024, mettant en avant des développements clés et des performances financières. L'entreprise attend l'approbation finale de la FDA pour YUTREPIA™ après l'expiration de l'exclusivité réglementaire le 23 mai 2025, suite à son approbation provisoire pour le traitement de la PAH et de la PH-ILD en août 2024.
Les points forts financiers incluent :
- Position de trésorerie de $176,5 millions au 31 décembre 2024
- Les revenus ont diminué à $14,0 millions contre $17,5 millions en 2023
- La perte nette s'est élargie à $130,4 millions ($1,66 par action) contre $78,5 millions en 2023
L'entreprise a renforcé sa position financière grâce à un accord modifié avec HealthCare Royalty Partners, offrant un accès à jusqu'à $100 millions de financement supplémentaire. L'étude ASCENT évaluant YUTREPIA chez les patients atteints de PH-ILD est proche de son achèvement, tandis que le développement de L606, une formulation liposomale de tréprostinil à prendre deux fois par jour, continue de progresser.
Liquidia (NASDAQ: LQDA) hat seine Finanzzahlen für das gesamte Jahr 2024 veröffentlicht und dabei wichtige Entwicklungen sowie die finanzielle Leistung hervorgehoben. Das Unternehmen wartet auf die endgültige Genehmigung der FDA für YUTREPIA™, nachdem die regulatorische Exklusivität am 23. Mai 2025 abläuft, nachdem es im August 2024 eine vorläufige Genehmigung zur Behandlung von PAH und PH-ILD erhalten hat.
Die finanziellen Höhepunkte umfassen:
- Liquiditätsposition von $176,5 Millionen zum 31. Dezember 2024
- Umsatz ist auf $14,0 Millionen von $17,5 Millionen im Jahr 2023 gesunken
- Der Nettoverlust hat sich auf $130,4 Millionen ($1,66 pro Aktie) von $78,5 Millionen im Jahr 2023 ausgeweitet
Das Unternehmen hat seine finanzielle Position durch eine geänderte Vereinbarung mit HealthCare Royalty Partners gestärkt, die den Zugang zu bis zu $100 Millionen an zusätzlicher Finanzierung ermöglicht. Die ASCENT-Studie, die YUTREPIA bei PH-ILD-Patienten bewertet, nähert sich dem Abschluss, während die Entwicklung von L606, einer liposomalen Treprostinil-Formulierung zur zweimal täglichen Einnahme, weiterhin voranschreitet.
- Secured up to $100M additional financing through amended HCRx agreement
- Strong cash position of $176.5M as of December 2024
- YUTREPIA received tentative FDA approval for both PAH and PH-ILD indications
- Positive progress in L606 clinical trials with successful patient dosing
- Revenue declined 20% to $14.0M from $17.5M year-over-year
- Net loss increased 66% to $130.4M from $78.5M in 2023
- General and administrative expenses surged 82% to $81.6M
- Research and development expenses increased 11% to $47.8M
Insights
Liquidia's full-year 2024 results reveal a company strategically positioning for a potential commercial launch of YUTREPIA in mid-2025 while absorbing significant pre-launch investments. The company's net loss widened to
The amended HCRx financing agreement provides important runway with up to
Revenue decreased to
The
Liquidia's progress with YUTREPIA represents a significant potential advancement for pulmonary hypertension treatment. Having secured tentative FDA approval for both PAH and PH-ILD indications, the company now awaits the May 23, 2025 expiration of Tyvaso DPI's regulatory exclusivity to receive final approval. This will offer patients an alternative dry powder formulation of treprostinil, a well-established prostacyclin therapy.
The near-completion of the ASCENT study evaluating YUTREPIA in PH-ILD patients demonstrates consistent tolerability with previous PAH findings, suggesting a promising efficacy profile across both indications. This is particularly important as PH-ILD represents a significant unmet need with fewer treatment options than PAH.
The advancement of L606 (liposomal treprostinil inhalation suspension) offers a potentially meaningful innovation with twice-daily dosing using a next-generation nebulizer. Current data showing patients safely titrating to doses comparable to 26-28 breaths of Tyvaso administered four times daily suggests improved convenience without sacrificing therapeutic effect. The FDA's confirmation that a single placebo-controlled study in PH-ILD could support approval for both indications significantly streamlines the development pathway.
Liquidia's two-pronged approach with both dry powder (YUTREPIA) and nebulized suspension (L606) formulations demonstrates a sophisticated clinical strategy addressing different patient preferences and needs. If approved, these formulations could potentially improve treatment adherence through simplified administration, which remains a significant challenge with existing prostacyclin therapies that require more frequent dosing or complex delivery systems.
- Targeting final FDA approval of YUTREPIA™ after expiration of regulatory exclusivity on May 23, 2025
- Advancing pipeline of inhaled treprostinil products in clinical studies
- Strengthened financial position by up to
$100 million via amendment to existing financing agreement with HealthCare Royalty Partners (HCRx) - Company to host webcast today at 8:30 a.m. ET
MORRISVILLE, N.C., March 19, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today reported financial results for the full year ended December 31, 2024. The company will also host a webcast at 8:30 a.m. ET on March 19, 2025 to discuss its financial results and provide a corporate update.
Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “Building on our progress this past year, Liquidia has strengthened its financial position, with up to an additional
Corporate Updates
Potential for final FDA approval of YUTREPIA (treprostinil) inhalation powder after expiration of regulatory exclusivity on May 23, 2025
On August 16, 2024, the United States Food and Drug Administration (FDA) granted tentative approval for YUTREPIA for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) and simultaneously determined that Tyvaso DPI® qualifies for a three-year New Clinical Investigation (NCI) exclusivity for the chronic use of dry powder formulations of treprostinil for the approved indications. The NCI exclusivity will expire on May 23, 2025, after which the FDA may grant final approval of YUTREPIA.
Continuing to advance the pipeline of inhaled treprostinil in the clinic
The open-label ASCENT study evaluating the tolerability and titratability of YUTREPIA in patients with PH-ILD is nearing enrollment completion. Observations to date have demonstrated tolerability and titratability of YUTREPIA in PH-ILD patients that is consistent with observations from the prior INSPIRE study in PAH patients.
Liquidia continues to progress clinical studies of L606 (liposomal treprostinil) inhalation suspension, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer. The U.S. open-label safety study of 28 patients with PAH and PH-ILD remains ongoing. To date, participants have safely titrated to the study’s maximum dose twice daily, which is comparable to 26-28 breaths of Tyvaso® administered four times per day. The FDA has confirmed that a single, placebo-controlled, global pivotal study in PH-ILD patients would support seeking approval to treat both PAH and PH-ILD patients.
Strengthened financial position by amending HCRx agreement to incrementally add up to
In March 2025, Liquidia entered into an amendment to its agreement with HCRx (HCR Agreement) to provide for up to an additional
Full Year 2024 Financial Results
Cash and cash equivalents totaled
Revenue was
Cost of revenue was
Research and development expenses were
General and administrative expenses were
Total other expense, net was
Net loss for the year ended December 31, 2024, was
About YUTREPIA™ (treprostinil) Inhalation Powder
YUTREPIA is an investigational, inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. In August 2024, the FDA issued tentative approval of YUTREPIA for the PAH and PH-ILD indications. YUTREPIA was designed using Liquidia’s PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension, to evaluate the safety and tolerability of YUTREPIA in PH-ILD patients. YUTREPIA was previously referred to as LIQ861 in investigational studies.
About L606 (liposomal treprostinil) Inhalation Suspension
L606 is an investigational, sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer. The L606 suspension uses Pharmosa Biopharm’s proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lung, enhancing drug exposure over an extended period of time. L606 is currently being evaluated in an open-label study in the United States for treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) with a planned global pivotal placebo-controlled efficacy study for the treatment of PH-ILD.
About Treprostinil Injection
Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same strengths, same dosage form and same inactive ingredients as Remodulin® (treprostinil) and is offered to patients and physicians with the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate use of Treprostinil Injection for the treatment of PAH in the United States in partnership with its commercial partner, Sandoz, who holds the Abbreviated New Drug Application (ANDA) with the FDA.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, an estimated 45,000 patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression and improve quality of life.
About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Pulmonary hypertension (PH) associated with interstitial lung disease (ILD) includes a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease related ILD, and chronic pulmonary fibrosis with emphysema (CPFE) among others. Any level of PH in ILD patients is associated with poor 3-year survival. A current estimate of PH-ILD prevalence in the United States is greater than 60,000 patients, though actual prevalence in many of these underlying ILD diseases is not yet known due to factors including underdiagnosis and lack of approved treatments until March 2021 when inhaled treprostinil was first approved for this indication.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIA™ (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.
Remodulin® and Tyvaso® are registered trademarks of United Therapeutics Corporation.
Cautionary Statements Regarding Forward-Looking Statements
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related submission contents and timelines, including the potential for final FDA approval of the NDA for YUTREPIA, which may occur after the expiration of the exclusivity period of TYVASO DPI, if at all, the timelines or outcomes related to patent litigation with United Therapeutics in the U.S. District Court for the District of Delaware, litigation with United Therapeutics and FDA in the U.S. District Court for the District of Columbia or other litigation instituted by United Therapeutics or others, including rehearings or appeals of decisions in any such proceedings, the issuance of patents by the USPTO and our ability to execute on our strategic or financial initiatives, the potential for additional funding under the HCR Agreement, our anticipated use of net proceeds funded under the HCR Agreement, our estimates regarding future expenses, capital requirements and needs for additional financing, and potential revenue and profitability of YUTREPIA, if approved, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. The favorable decisions of courts or other tribunals are not determinative of the outcome of the appeals or rehearings of the decisions. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the SEC, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information
Investors:
Jason Adair
Chief Business Officer
919.328.4350
Jason.adair@liquidia.com
Media:
Patrick Wallace
Director, Corporate Communications
919.328.4383
patrick.wallace@liquidia.com
Liquidia Corporation Select Condensed Consolidated Balance Sheet Data (unaudited) (in thousands) | |||||||||
December 31, | December 31, | ||||||||
2024 | 2023 | ||||||||
Cash and cash equivalents | $ | 176,479 | $ | 83,679 | |||||
Total assets | $ | 230,313 | $ | 118,332 | |||||
Total liabilities | $ | 153,038 | $ | 71,039 | |||||
Accumulated deficit | $ | (559,492 | ) | $ | (429,098) | ||||
Total stockholders’ equity | $ | 77,275 | $ | 47,293 |
Liquidia Corporation Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts) | ||||||||||
Full Year Ended December 31, | ||||||||||
2024 | 2023 | |||||||||
Revenue | $ | 13,996 | $ | 17,488 | ||||||
Costs and expenses: | ||||||||||
Cost of revenue | $ | 5,879 | $ | 2,888 | ||||||
Research and development | $ | 47,842 | $ | 43,242 | ||||||
General and administrative | $ | 81,569 | $ | 44,742 | ||||||
Total costs and expenses | $ | 135,290 | $ | 90,872 | ||||||
Loss from operations | $ | (121,294 | ) | $ | (73,384 | ) | ||||
Other income (expense): | ||||||||||
Interest income | $ | 7,654 | $ | 3,466 | ||||||
Interest expense | $ | (12,486 | ) | $ | (6,273 | ) | ||||
Gain (loss) on extinguishment of debt | $ | (4,268 | ) | $ | (2,311 | ) | ||||
Total other expense, net | $ | (9,100 | ) | $ | (5,118 | ) | ||||
Net loss and comprehensive loss | $ | (130,394 | ) | $ | (78,502 | ) | ||||
Net loss per common share, basic and diluted | $ | (1.66 | ) | $ | (1.21 | ) | ||||
Weighted average common shares outstanding, basic and diluted | $ | 78,707,503 | $ | 64,993,476 | ||||||
