Full Press Release Details
Corporation Reports Third Quarter 2023 Financial Results and Provides Corporate Update
MORRISVILLE, N.C., November 7,
2023 - Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the third quarter
ended September 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: "We continue to make great strides in advancing our mission to help patients with pulmonary
hypertension breathe easier and live longer. We are looking forward to upcoming key events that will help unlock the value of
YUTREPIA (treprostinil) inhalation powder, with pivotal legal arguments set in early December and potential label
expansion of YUTREPIA for PH-ILD in late January. In anticipation of potential successful resolution of the ongoing legal dispute
with United Therapeutics and receiving final FDA approval, we have expanded our top-tier sales force, all of whom are deeply skilled
in the commercialization of rare disease products. If successful, we look forward to promoting the benefits of YUTREPIA's
unmatched product profile, specifically its tolerability, titratability, and durability, all delivered via a patient-friendly
low-effort device enabled by our proprietary PRINT technology."
PDUFA goal date to add PH-ILD indication to YUTREPIA label. The U.S. Food and Drug Administration (FDA) accepted the amendment to
the New Drug Application (NDA) for YUTREPIA to add the indication of pulmonary hypertension associated
with interstitial lung disease (PH-ILD) to the label and has set a Prescription Drug User Fee Act
(PDUFA) goal date of January 24, 2024. If approved, YUTREPIA would be indicated for the treatment of both pulmonary arterial hypertension
(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 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. In September 2023, United Therapeutics (UTHR) filed a second complaint for patent infringement against
the Company under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware (District Court), asserting infringement
of U.S. Patent No. 10,716,793 ( 793 Patent). This second complaint is tied to the
same 793 patent previously ruled invalid by Patent Trial and Appeal Board (PTAB).
Oral arguments for appeal of PTAB
ruling of 793 Patent invalidity scheduled for December 4, 2023. Final regulatory approval of YUTREPIA is currently barred by
an order from earlier Hatch-Waxman proceedings in the District Court in which the 793 Patent was found to be valid and infringed.
However, in a parallel proceeding before the PTAB, the 793 Patent was found to be invalid. If the PTAB's decision is affirmed
by the Court of Appeals for the Federal Circuit (CAFC), then the PTAB's decision would override the decision from the District
Court proceeding, thereby creating the opportunity for the Company to seek final FDA approval for YUTREPIA. 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.
Additionally, if the CAFC upholds the PTAB decision in Liquidia's favor, then such ruling would have precedential effect in the
second lawsuit recently filed by UTHR alleging infringement of the 793 Patent in connection with the amendment of YUTREPIA's
NDA to add the PH-ILD indication.
Fully transitioned clinical development
of L606 from Pharmosa to Liquidia for the North American territory. In June, Liquidia acquired an exclusive license to develop and
commercialize L606, an inhaled, sustained-release formulation of treprostinil currently being evaluated in a Phase 3 open-label clinical
trial for the treatment of PAH and PH-ILD. Compared to current inhaled options, L606 offers potential advantages of more consistent drug
exposure over 24 hours, including during sleeping hours, with twice-daily dosing and improved tolerability via a modern, next-gen nebulizer.
Liquidia has assumed full responsibility for the investigational new drug (IND) and is preparing for a Type C meeting with the FDA in
December to discuss the registration pathway for PAH and PH-ILD.
Quarter 2023 Financial Results
totaled $76.2 million as of September 30, 2023, compared to $93.3 million as of December 31, 2022.
was $3.7 million for the three months ended September 30, 2023, compared to $3.2 million for the three months ended September 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 Promotion Agreement).
The increase from the prior year was primarily due to favorable gross-to-net managed care and chargeback adjustments offset by the impact
of lower sales quantities as compared to the same period in the prior year.
of revenue was $0.6 million for the three months ended September 30, 2023, compared to $0.7 million for the three months ended September
30, 2022. Cost of revenue related to the Promotion Agreement as noted above. The decrease from the
prior year was primarily due to lower intangible asset amortization due to an extension of the term of the Promotion Agreement during
the fourth quarter of 2022.
and development expenses were $7.4 million for the three months ended September 30, 2023, compared to $4.5 million for the three
months ended September 30, 2022. The increase of $2.9 million or 65% was primarily due to a $1.5 million increase in expenses related
to our YUTREPIA program driven by higher manufacturing and pre-launch commercial supply costs, a $0.7 million increase in consulting
and personnel expenses related to higher headcount, and a $0.4 million increase in clinical expenses related to our L606 open label study.
and administrative expenses were $10.6 million for the three months ended September 30, 2023, compared to $6.7 million for the three
months ended September 30, 2022. The increase of $3.9 million or 57% was primarily due to a $1.4 million increase in legal fees related
to our ongoing YUTREPIA-related litigation, a $0.9 million increase in consulting and personnel expenses in preparation for the potential
commercialization of YUTREPIA, a $0.7 million increase in commercial expenses, and a $0.6 million increase in stock-based compensation
Total other expense, net was
$0.9 million for the three months ended September 30, 2023, compared with $0.3 million for the three months ended September 30, 2022.
The increase of $0.6 million was driven by $1.1 million higher 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 offset by a $0.5 million increase in interest income attributable
to higher money market yields.
Net loss for the three months
ended September 30, 2023, was $15.8 million, or $0.24 per basic and diluted share, compared to a net loss of $9.1 million, or $0.14 per
basic and diluted share, for the three months ended September 30, 2022.
About YUTREPIA (treprostinil)
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 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. In July 2023, Liquidia filed
an amendment to its NDA for YUTREPIA, seeking to add pulmonary hypertension with interstitial lung disease (PH-ILD) to the label. The
FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024 for the amendment. Previously, the FDA has confirmed
that YUTREPIA may add the treatment of PH-ILD to the label for YUTREPIA 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.
(liposomal treprostinil) inhalation suspension
investigational, sustained-release 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.
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.
arterial hypertension (PAH)
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.
hypertension associated with interstitial lung disease (PH-ILD)
Pulmonary hypertension