Full Press Release Details
Corporation Reports Third Quarter 2024 Financial Results
and Provides Corporate Update
N.C., November 13, 2024 - 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."
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.
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.
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 $3.5 million initial payment following execution
of the amendment and may receive up to $157.75 million in additional development and sales milestones tied to activities in
territories outside of North America. Liquidia continues to treat patients with L606 in the ongoing open-label U.S. study.
Strengthened financial position by approximately $100 million through
equity raise and advance from financing agreement
In September, Liquidia closed on an underwritten public offering and
a concurrent private placement with total gross proceeds of $67.5 million, before deducting underwriting discounts and commissions,
and transaction-related expenses. Liquidia also entered into a fifth amendment to the Revenue Interest Financing Agreement (RIFA)
with HealthCare Royalty (HCRx) for HCRx to fund an additional $32.5 million to the company. With this amendment, HCRx has funded
the full $100 million in non-dilutive capital as originally contemplated under the RIFA entered into in January 2023.
Third Quarter 2024 Financial
Cash and cash equivalents
totaled $204.4 million as of September 30, 2024, compared to $83.6 million as of December 31, 2023.
Revenue was $4.4 million for the three months
ended September 30, 2024, compared to $3.7 million for the three months ended September 30, 2023. Revenue related
primarily to the promotion agreement with Sandoz, Inc. (Sandoz) pursuant to which we share profits from the sale of Treprostinil
Injection in the United States (the Promotion Agreement). The increase of $0.7 million was primarily due to the
impact of higher sales quantities in the current year as compared to the same period in the prior year.
Cost of revenue was $1.6 million for the three months ended September 30, 2024,
compared to $0.6 million for the three months ended September 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.
Research and development expenses were $11.9 million for the three
months ended September 30, 2024, compared to $7.4 million for the three months ended September 30, 2023. The increase
of $4.5 million or 60% was primarily due to a $2.1 million increase in personnel expenses (including stock-based compensation) related
to increased headcount, a $1.3 million increase in clinical expenses related to our L606 program, and a $2.5 million increase in expenses
related to YUTREPIA research and development activities, including the ASCENT trial, offset by $1.5 million lower commercial manufacturing
expenses reflecting the impact of expensing YUTREPIA inventory costs in the prior year.
General and administrative expenses were $20.2 million for the three
months ended September 30, 2024, compared to $10.6 million for the three months ended September 30, 2023. The increase
of $9.6 million or 91% was primarily due to a $6.7 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 $1.5 million
increase in legal fees related to our ongoing YUTREPIA-related litigation, and a $0.5 million increase
in commercial expenses in preparation for the potential commercialization of YUTREPIA.
Total other income, net was $6.0 million for the three months ended
September 30, 2024, compared with total other expense, net of $0.9 million for the three months ended September 30, 2023.
The variance was primarily driven by a $7.2 million gain on extinguishment of debt resulting from the Fifth Amendment to the RIFA, which
was executed in September 2024. Additionally, there was a $1.2 million increase in interest expense attributable to the higher borrowings
under the RIFA as compared to the prior year and a $1.0 million increase in interest income attributable to higher money market balances.
Net loss for the three months
ended September 30, 2024, was $23.2 million or $0.30 per basic and diluted share, compared to a net loss of $15.8
million, or $0.24 per basic and diluted share, for the three-month ended September 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. 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 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, 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.