Liquidia Corporation Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Liquidia (NASDAQ: LQDA) reported Q3 2024 financial results, highlighting key developments including FDA tentative approval for YUTREPIA™ for PAH and PH-ILD treatments. Revenue increased to $4.4M from $3.7M year-over-year. The company strengthened its balance sheet by raising approximately $100M through equity offering and financing agreement. Net loss widened to $23.2M ($0.30 per share) compared to $15.8M ($0.24 per share) in Q3 2023. Cash position improved to $204.4M as of September 30, 2024. Launch of YUTREPIA is currently gated until May 23, 2025, due to TYVASO DPI's exclusivity period.
Liquidia (NASDAQ: LQDA) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando sviluppi chiave tra cui l'approvazione temporanea da parte della FDA per YUTREPIA™ per il trattamento dell'ipertensione arteriosa polmonare (PAH) e dell'ILD ipertensivo polmonare (PH-ILD). I ricavi sono aumentati a 4,4 milioni di dollari rispetto ai 3,7 milioni dell'anno precedente. L'azienda ha rafforzato il proprio bilancio raccogliendo circa 100 milioni di dollari attraverso un'offerta di capitale e un accordo di finanziamento. La perdita netta è aumentata a 23,2 milioni di dollari (0,30 dollari per azione) rispetto ai 15,8 milioni di dollari (0,24 dollari per azione) nel terzo trimestre 2023. La posizione di liquidità è migliorata a 204,4 milioni di dollari al 30 settembre 2024. Il lancio di YUTREPIA è attualmente sospeso fino al 23 maggio 2025, a causa del periodo di esclusività di TYVASO DPI.
Liquidia (NASDAQ: LQDA) informó los resultados financieros del tercer trimestre de 2024, destacando desarrollos clave como la aprobación tentativa de la FDA para YUTREPIA™ en el tratamiento de PAH y PH-ILD. Los ingresos aumentaron a 4,4 millones de dólares desde 3,7 millones del año anterior. La compañía fortaleció su balance al recaudar aproximadamente 100 millones de dólares a través de una oferta de acciones y un acuerdo de financiación. La pérdida neta se amplió a 23,2 millones de dólares (0,30 dólares por acción) en comparación con 15,8 millones de dólares (0,24 dólares por acción) en el tercer trimestre de 2023. La posición de efectivo mejoró a 204,4 millones de dólares hasta el 30 de septiembre de 2024. El lanzamiento de YUTREPIA está actualmente restringido hasta el 23 de mayo de 2025, debido al período de exclusividad de TYVASO DPI.
리퀴디아 (NASDAQ: LQDA)는 2024년 3분기 재무 결과를 보고하며 PAH 및 PH-ILD 치료를 위한 YUTREPIA™에 대한 FDA의 잠정 승인을 포함한 주요 개발 사항을 강조했습니다. 매출은 전년 대비 370만 달러에서 440만 달러로 증가했습니다. 회사는 자본 공모 및 금융 계약을 통해 약 1억 달러를 조달하여 재무 상태를 강화했습니다. 순손실은 2023년 3분기의 1580만 달러(주당 0.24달러)에서 2320만 달러(주당 0.30달러)로 확대되었습니다. 현금 잔고는 2024년 9월 30일 기준으로 2억 440만 달러로 개선되었습니다. YUTREPIA의 출시는 TYVASO DPI의 독점 기간 때문에 현재 2025년 5월 23일까지 연기되었습니다.
Liquidia (NASDAQ: LQDA) a annoncé ses résultats financiers pour le troisième trimestre 2024, mettant en avant des développements clés, notamment l'approbation temporaire de la FDA pour YUTREPIA™ dans le traitement de l'HTAP et du PH-ILD. Le chiffre d'affaires a augmenté à 4,4 millions de dollars contre 3,7 millions l'année précédente. L'entreprise a renforcé son bilan en levant environ 100 millions de dollars par le biais d'une offre d'actions et d'un accord de financement. La perte nette s'est élargie à 23,2 millions de dollars (0,30 dollars par action) contre 15,8 millions de dollars (0,24 dollars par action) au troisième trimestre 2023. La position de trésorerie a amélioré à 204,4 millions de dollars au 30 septembre 2024. Le lancement de YUTREPIA est actuellement retardé jusqu'au 23 mai 2025 en raison de la période d'exclusivité de TYVASO DPI.
Liquidia (NASDAQ: LQDA) hat die Finanzzahlen für das dritte Quartal 2024 veröffentlicht und dabei wichtige Entwicklungen hervorgehoben, darunter die vorläufige Genehmigung der FDA für YUTREPIA™ zur Behandlung von PAH und PH-ILD. Der Umsatz stieg von 3,7 Millionen Dollar auf 4,4 Millionen Dollar im Jahresvergleich. Das Unternehmen hat seine Bilanz gestärkt, indem es durch eine Aktienemission und eine Finanzierungsvereinbarung etwa 100 Millionen Dollar aufgenommen hat. Der Nettoverlust hat sich auf 23,2 Millionen Dollar (0,30 Dollar pro Aktie) im Vergleich zu 15,8 Millionen Dollar (0,24 Dollar pro Aktie) im dritten Quartal 2023 ausgeweitet. Die Liquiditätsposition verbesserte sich zum 30. September 2024 auf 204,4 Millionen Dollar. Der Launch von YUTREPIA ist bis zum 23. Mai 2025 derzeit ausgesetzt, aufgrund der Exklusivitätsphase von TYVASO DPI.
- FDA granted tentative approval for YUTREPIA for both PAH and PH-ILD treatments
- Revenue increased 18.9% YoY to $4.4M
- Strengthened balance sheet with $100M additional capital
- Cash position increased to $204.4M from $83.6M at year-end 2023
- Favorable patent litigation outcomes with three patents now final and not subject to appeal
- Net loss increased to $23.2M from $15.8M YoY
- YUTREPIA launch delayed until May 2025 due to competitor's exclusivity period
- R&D expenses increased 60% to $11.9M
- G&A expenses rose 91% to $20.2M
- Ongoing litigation costs increasing due to YUTREPIA-related legal proceedings
Insights
Liquidia's Q3 results show significant strategic progress but widening losses. Notable financial highlights include a strengthened balance sheet with
The regulatory and legal landscape shows mixed developments. The FDA's tentative approval for YUTREPIA for both PAH and PH-ILD indications is positive, but launch is blocked until May 2025 due to TYVASO DPI's exclusivity. The Supreme Court's rejection of United Therapeutics' appeal regarding the '793 patent marks a significant victory, clearing three major patent hurdles. However, challenges remain with the '327 patent litigation scheduled for June 2025. The company's proactive lawsuit against the FDA's exclusivity decision, with a hearing scheduled for December 2024, could potentially accelerate market entry.
- Received tentative approval from the FDA for YUTREPIA™ (treprostinil) inhalation powder for both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)
- U.S. Supreme Court rejected final appeal of ‘793 patent decision, marking victories with respect to three patents originally asserted final and not subject to further appeal
- Strengthened balance sheet by raising approximately
$100 million in additional capital
MORRISVILLE, N.C., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today reported financial results for the third quarter ended September 30, 2024. The company will host a webcast at 8:30 a.m. ET on November 13, 2024, to discuss the financial results and provide a corporate update.
Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “This quarter we achieved our goal of adding pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the indication statement for YUTREPIA™. While the FDA decision to grant three-year exclusivity to TYVASO DPI®, which will expire on May 23, 2025, currently gates our launch, we will exhaust every effort to bring YUTREPIA to market sooner, as evidenced by our litigation against the FDA to contest what we believe to be the improper grant of exclusivity to TYVASO DPI. In the interim, we will use this pre-launch period to further advance knowledge of the clinical profile of YUTREPIA in PH-ILD patients through our ASCENT study, where we hope to show YUTREPIA’s clear advantages related to the tolerability, titratability and durability in this underserved patient population.”
Corporate Updates
Received tentative approval from the FDA for YUTREPIA (treprostinil) inhalation powder
In August, the FDA granted tentative approval for YUTREPIA for the treatment of patients with pulmonary arterial hypertension (PAH) and PH-ILD. At present, final approval of YUTREPIA is delayed until after expiration on May 23, 2025, of the new clinical investigation (NCI) exclusivity that was granted to TYVASO DPI.
Commenced litigation to challenge regulatory exclusivity blocking final approval of YUTREPIA
In August, Liquidia filed a lawsuit in the U.S. District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the decision by the U.S. Food and Drug Administration (FDA) to grant 3-year NCI exclusivity to Tyvaso DPI. Liquidia and the FDA have agreed to an expedited briefing schedule in anticipation of a hearing on the parties’ respective motions for summary judgment on December 5, 2024.
Favorable decisions related to three patents originally asserted against Liquidia are now final and not subject to further appeal
In October, the U.S. Supreme Court rejected the petition filed by United Therapeutics (UTHR) for a writ of certiorari, seeking to appeal prior decisions which found that all claims of U.S. Patent No. 10,716,793 (‘793 Patent) are unpatentable. As a result, all disputes regarding the three patents originally asserted by UTHR have now been fully resolved. No valid claims of any of the three patents originally asserted by UTHR are infringed by Liquidia, and all of the decisions are now final and not subject to further appeal. With this decision, UTHR now has no remaining claims in which it is contesting approval of YUTREPIA for the treatment of PAH after the expiration of NCI exclusivity in May 2025.
With the final resolution of the litigation related to the three patents originally asserted against Liquidia by UTHR, the sole remaining patent asserted by UTHR against Liquidia is U.S. Patent No. 11,826,327 (‘327 Patent) related to the treatment of PH-ILD patients. In May 2024, the U.S. District Court of the District of Delaware denied UTHR’s request for a preliminary injunction with respect to the ‘327 Patent. A trial in the ‘327 Patent lawsuit is currently scheduled for June 2025.
Expanded collaboration with Pharmosa Biopharm to develop L606 (liposomal treprostinil) inhalation suspension
In October, Liquidia and Pharmosa amended an exclusive licensing agreement for the development and commercialization of L606, an inhaled, sustained-release formulation of treprostinil currently being evaluated in a clinical trial for the treatment of PAH and PH-ILD. The amendment expands Liquidia’s licensed territory beyond North America to include key markets in Europe, Japan and elsewhere. In addition, Liquidia has obtained rights to Pharmosa’s next-generation nebulizers for use with L606. As part of the amendment, Pharmosa received a
Strengthened financial position by approximately
In September, Liquidia closed on an underwritten public offering and a concurrent private placement with total gross proceeds of
Third Quarter 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 income, net was
Net loss for the three months ended September 30, 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, 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) | |||||||
| September 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Cash and cash equivalents | $ | 204,368 | $ | 83,679 | |||
| Total assets | $ | 252,886 | $ | 118,332 | |||
| Total liabilities | $ | 142,368 | $ | 71,039 | |||
| Accumulated deficit | $ | (521,123 | ) | $ | (429,098 | ) | |
| Total stockholders’ equity | $ | 110,518 | $ | 47,293 | |||
| Liquidia Corporation Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts) | |||||||
| Three Months Ended September, | |||||||
| 2024 | 2023 | ||||||
| Revenue | $ | 4,448 | $ | 3,678 | |||
| Costs and expenses: | |||||||
| Cost of revenue | $ | 1,565 | $ | 570 | |||
| Research and development | $ | 11,890 | $ | 7,440 | |||
| General and administrative | $ | 20,182 | $ | 10,559 | |||
| Total costs and expenses | $ | 33,637 | $ | 18,569 | |||
| Loss from operations | $ | (29,189 | ) | $ | (14,891 | ) | |
| Other income (expense): | |||||||
| Interest income | $ | 1,815 | $ | 862 | |||
| Interest expense | $ | (2,996 | ) | $ | (1,761 | ) | |
| Gain on extinguishment of debt | $ | 7,215 | $ | — | |||
| Total other expense, net | $ | 6,034 | $ | (899 | ) | ||
| Net loss and comprehensive loss | $ | (23,155 | ) | $ | (15,790 | ) | |
| Net loss per common share, basic and diluted | $ | (0.30 | ) | $ | (0.24 | ) | |
| Weighted average common shares outstanding, basic and diluted | $ | 78,316,820 | $ | 64,857,508 | |||
FAQ
When did Liquidia (LQDA) receive FDA tentative approval for YUTREPIA?
What was Liquidia's (LQDA) revenue in Q3 2024?
When can Liquidia (LQDA) launch YUTREPIA?
How much capital did Liquidia (LQDA) raise in Q3 2024?
