Full Press Release Details
Corporation Reports Second Quarter 2024 Financial Results and
Provides Corporate Update
N.C., August 7, 2024 -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative
therapies for patients with rare cardiopulmonary disease, today reported financial results for the second quarter ended June 30,
2024. The company will host a webcast at 8:30 a.m. ET on August 7, 2024 to discuss the financial results
and provide a corporate update.
Dr. Roger Jeffs, Liquidia's Chief Executive
Officer, said: "We continue to face no legal impediments for the FDA approval of YUTREPIA for the treatment of pulmonary arterial
hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), and our commercial team stands ready
to launch YUTREPIA contingent on the FDA's final approval. If approved, we firmly believe that the ease of administration and broad
dosage spectrum of YUTREPIA will drive the treatment to become the preferred prostacyclin therapy of choice."
Progressed litigation, maintaining a clear legal path to full approval
Andrews of the U.S. District Court for the District of Delaware denied the motion for preliminary injunction filed by United
Therapeutics (UTHR) in its lawsuit alleging that YUTREPIA infringes U.S. Patent No. 11,826,327 ( 327 patent).
on March 29, the U.S. District Court for the District of Columbia has denied motions for a temporary restraining order and preliminary
injunction requested by UTHR in its suit against the U.S. Food and Drug Administration (FDA). On May 7, both Liquidia and FDA filed
motions to dismiss UTHR's complaint.
While both lawsuits are continuing forward, these rulings reinforce
the clear legal path for FDA to issue a final decision on the amended New Drug Application (NDA) for YUTREPIA for the treatment of both
Progressed clinical studies in YUTREPIA and presented new posters
at the World Symposia on Pulmonary Hypertension
the World Symposia on Pulmonary Hypertension in Barcelona this summer, Liquidia presented two
live thematic poster sessions and five encore presentations covering the company's investigational products, YUTREPIA (treprostinil)
inhalation powder and L606 (liposomal treprostinil) inhalation suspension. The two new posters entitled: "Exploratory
Efficacy Analysis of INSPIRE Open Label Extension Study with Inhaled Treprostinil (YUTREPIA )" and "High Resolution
Computed Tomography (HRCT) Chest Scans to Examine the Association Between Regional Drug Deposition of LIQ861 (YUTREPIA ) and Vasodilation
in PH-ILD Population," along with the five encore presentations, can be found on the Publications section
of Liquidia's website.
Progressed L606 in clinic and presented summary of safety and dosing
poster at the American Thoracic Society 2024 International Conference (ATS)
In May at the ATS Conference in San Diego, Liquidia presented
data related to the investigational use of L606 (liposomal treprostinil) inhalation suspension in patients with pulmonary arterial hypertension
(PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH or PH-ILD in the short-term
and long-term. The trial is enrolling patients in two groups, a transition group and a na ve group. The transition group is comprised
of participants with PAH or PH-ILD who transitioned from nebulized Tyvaso or Tyvaso DPI to L606. The na ve group is comprised of
participants with PAH who have not previously received treprostinil therapy and added L606 to no more than two non-prostacyclin oral
Second Quarter 2024 Financial
Cash and cash equivalents
totaled $133.1 million as of June 30, 2024, compared to $83.7 million as of December 31, 2023.
was $3.7 million for the three months ended June 30, 2024, compared to $4.8 million for the three months ended June 30,
2023. Revenue related primarily to our promotion agreement with Sandoz pursuant to which we share profits from the sale of
Treprostinil Injection in the United States (the Promotion Agreement). The decrease of $1.1 million was primarily due to the
impact of lower sales quantities in the current year as compared to the same period in the prior year.
of revenue was $1.5 million for the three months ended June 30, 2024, compared to $0.7 million for the three
months ended June 30, 2023. Cost of revenue related to the Promotion Agreement as noted above. The increase from the
prior year was primarily due to our sales force expansion during the fourth quarter of 2023.
and development expenses were $9.4 million for the three months ended June 30, 2024, compared to $17.7 million for
the three months ended June 30, 2023. The decrease of $8.3 million or 47% was primarily due to a $10 million upfront
license fee due to Pharmosa for the exclusive license in North America to develop and commercialize L606 recorded during the three months
ended June 30, 2023. Additionally, there was a $1.4 million decrease in expenses related to our YUTREPIA program driven by expensing
prelaunch inventory costs in the prior year. These decreases were offset by a $1.7 million increase in clinical expenses related to our
L606 program and a $1.5 million increase in personnel expenses (including stock-based compensation) related to increased headcount.
and administrative expenses were $20.0 million for the three months ended June 30, 2024, compared to $9.2 million for
the three months ended June 30, 2023. The increase of $10.8 million or 116% was primarily due to a
$6.3 million increase in personnel expenses (including stock-based compensation) driven by higher headcount and expansion of our sales
force in the fourth quarter of 2023, a $2.2 million increase in commercial and consulting expenses in preparation for the potential commercialization
of YUTREPIA, and a $0.9 million increase in legal fees related to our ongoing YUTREPIA-related
other expenses, net was $0.7 million for both the three months ended June 30, 2024 and 2023. There was a $1.2 million
increase in interest expenses attributable to the higher borrowings under the company's Revenue Interest Financing Agreement (RIFA)
with HealthCare Royalty Partners (HCRx) as compared to the prior year, and a $1.1 million increase in interest income attributable to
higher money market balances.
Net loss for the three months
ended June 30, 2024, was $27.9 million or $0.37 per basic and diluted share, compared to a net loss of $23.5
million, or $0.36 per basic and diluted share, for the three-month ended June 30, 2023.
YUTREPIA (treprostinil) Inhalation Powder
YUTREPIA is an investigational, inhaled dry-powder formulation of treprostinil
delivered through a convenient, low-effort, palm-sized device. The FDA previously issued tentative approval of YUTREPIA for the PAH indication
in November 2021. In July 2023, Liquidia filed an amendment to its New Drug Application for YUTREPIA, seeking
to add PH-ILD to the label. 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 na ve 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,
with the objective of informing YUTREPIA's dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred
to as LIQ861 in investigational studies.
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 and potentially mitigating local and systemic side effects. 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.
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, Inc. (Sandoz), who holds the Abbreviated
New Drug Application (ANDA) with the FDA.
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.
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