Full Press Release Details
Corporation Reports Second Quarter 2023 Financial Results and Provides Corporate Update
N.C., August 10, 2023 - Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial
results for the second quarter ended June 30, 2023. The Company will host a webcast at 8:30 a.m. ET to discuss the financial
results and provide a corporate update.
Dr. Roger Jeffs, Liquidia's Chief Executive Officer,
said: "This quarter saw Liquidia significantly advance our mission to become the leading inhaled treprostinil provider for
pulmonary hypertension patients. Achievements of note include: 1) the affirmation by the U.S. Court of Appeals for the Federal
Circuit (CAFC) that all claims of the No. 9,593,066 ( 066 patent) are invalid or not infringed, 2) the filing of an
amendment to add PH-ILD to the YUTREPIA label, and 3) the license of L606 from Pharmosa Biopharm to develop and commercialize a
sustained-release liposomal formulation of treprostinil for twice-daily nebulization. With these achievements in mind, we we will
continue to prepare for a potential launch of YUTREPIA in the near future, both for PAH and subsequently PH-ILD."
litigation with United Therapeutics. With the decision of the CAFC issued in July with respect to the Hatch-Waxman litigation
between Liquidia and United Therapeutics Corporation (UTHR), only one of the three patents originally asserted against Liquidia in Hatch-Waxman
litigation, U.S. Patent No. 10,716,793 ( 793 Patent), remains gating to final approval for YUTREPIA. In July 2022, the
Patent Trial and Appeal Board (PTAB) found the 793 Patent to be unpatentable due to the existence of prior art as cited in the
inter partes review filed by Liquidia. The PTAB then re-affirmed that decision in February 2023, and UTHR appealed the decision
to the CAFC. Briefing in the appeal should be completed in fourth quarter 2023 and oral arguments will be heard on the next available
date in the oral argument calendar, expected to be late fourth quarter 2023 to early 2024. Once argued, the CAFC could rule within
a few days, in the case of summary affirmance, or within a few months after oral argument if a full written opinion is issued. If affirmed
by the CAFC, the PTAB's decision would override any earlier finding of infringement, and Liquidia would immediately seek final
regulatory approval for YUTREPIA.
amendment to add PH-ILD indication to tentatively approved new drug application (NDA) for YUTREPIA. The
U.S. Food and Drug Administration (FDA) had previously confirmed that the additional PH-ILD indication would not require any new clinical
efficacy data. If approved, YUTREPIA would be indicated for the treatment of both PAH and PH-ILD, though final approval of the PH-ILD
indication cannot occur until the new clinical investigation exclusivity granted to Tyvaso expires on March 31,
2024. Concurrent with this amendment, Liquidia also submitted a paragraph IV certification indicating that the patents listed for Tyvaso
in the FDA's publication commonly known as the Orange Book are invalid and/or not infringed by YUTREPIA. All Orange Book
patents previously asserted by United Therapeutics have already been found to be invalid or not-infringed as decided by U.S. District
Court, confirmed on appeal, or by the PTAB, pending the appeal described above.
pipeline through partnership with Pharmosa Biopharm to develop L606 in North America. In June, Liquidia acquired an exclusive
license to develop and commercialize L606, an inhaled, sustained-release, liposomal formulation of treprostinil currently being evaluated
in a Phase 3 open-label clinical trial for the treatment of PAH and PH-ILD. L606 offers potential advantages of (a) less frequent
dose administrations, (b) more consistent drug exposure over 24 hours, including sleeping hours, (c) improved tolerability
via lower peak exposure, and (d) improved portability via a modern, next-gen nebulizer. Liquidia will be responsible for development,
regulatory and commercial activities of L606 in North America, while Pharmosa will manufacture clinical and commercial supplies of L606
and support Liquidia's effort to establishing a redundant global supply chain. Pending input from the FDA from a planned Type B
meeting later this year, Liquidia intends to initiate a Phase 3 randomized, placebo-controlled study in 2024 to evaluate treatment of
PH-LD patients with L606.
Quarter 2023 Financial Results
totaled $88.2 million as of June 30, 2023, compared to $93.3 million as of December 31,
was $4.8 million for the three months ended June 30, 2023, compared to $3.9 million
for the three months ended June 30, 2022. Revenue related primarily to the promotion agreement between Liquidia PAH and Sandoz Inc,
sharing profit derived from the sale of Sandoz's substitutable generic treprostinil injection (Treprostinil Injection) in the United
States. The increase of $0.9 million was primarily due to favorable gross-to-net chargeback and rebate adjustments.
of revenue was $0.7 million for both the three months ended June 30, 2023, and
2022. Cost of revenue related to the promotion agreement as noted above.
and development expenses were $17.7 million for the three months ended June 30,
2023, compared to $5.2 million for the three months ended June 30, 2022. The increase of $12.5 million or 239% was primarily due
to a $10.0 million upfront payment owed to Pharmosa for the exclusive license in North America to develop and commercialize L606. Additionally,
there was a $2.2 million increase in expenses related to our YUTREPIA program driven by higher manufacturing and supply costs.
and administrative expenses were $9.2 million for the three months ended June 30,
2023, compared to $6.9 million for the three months ended June 30, 2022. The increase of $2.3 million or 33% was primarily due to
a $1.3 million increase in consulting and personnel expenses in preparation for the potential commercialization of YUTREPIA, a $0.7 million
increase in legal fees related to our ongoing YUTREPIA-related litigation, and a $0.6 million increase in stock-based compensation expense.
other expense, net was $0.7 million for the three months ended June 30, 2023, compared
with $0.5 million for the three months ended June 30, 2022. Liquidia incurred an increase of $0.9 million in interest expense attributable
to the higher borrowings under the Revenue Interest Financing Agreement with HealthCare Royalty Partners as compared to balances outstanding
under the Amended and Restated Loan and Security Agreement with Silicon Valley Bank, and a $0.7 million increase in interest income attributable
to higher money market yields.
loss for the three months ended June 30, 2023, was $23.5 million, or $0.36 per basic and diluted share, compared to a
net loss of $9.4 million, or $0.15 per basic and diluted share, for the three months ended June 30, 2022.
About YUTREPIA (treprostinil) inhalation
YUTREPIA is an investigational, inhaled dry
powder formulation of treprostinil delivered through a convenient, low-resistance, palm-sized device. On November 5, 2021, the FDA
issued a tentative approval for YUTREPIA, which is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise
ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. The FDA has confirmed that YUTREPIA
may add the indication to treat pulmonary hypertension with interstitial lung disease (PH-ILD) without additional clinical studies. 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 was previously referred to as LIQ861 in investigational studies.
About L606 (liposomal treprostinil) inhalation
L606 is an investigational, liposomal formulation
of treprostinil administered twice-daily with a short-duration 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 reducing local irritation of the upper respiratory tract. 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 pivotal 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, who holds the
Abbreviated New Drug Application (ANDA) with the FDA.
About pulmonary arterial hypertension
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 population growth 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