Full Press Release Details
Liquidia Reports Third Quarter 2022 Financial
Results and Provides Corporate Update
N.C., November 8, 2022 - Liquidia Corporation (NASDAQ: LQDA) ("Liquidia" or the "Company")
today reported financial results for the third quarter ended September 30, 2022. The Company will host a webcast and conference call
at 8:30 a.m. ET to discuss the third quarter 2022 financial results and provide a corporate update.
Roger Jeffs, Liquidia's Chief Executive Officer, said: "The
third quarter marked a critical juncture in our mission to provide YUTREPIA (treprostinil) inhalation powder to patients with PAH
and PH-ILD. We have now demonstrated in at least one legal forum that each of the patent claims asserted against us is invalid or not
infringed. We will continue our relentless efforts to affirm these decisions in their respective appeals so that YUTREPIA can be provided
as an important new treatment option for physicians, patients and payors . The feedback from physicians and patients that we have received
continues to demonstrate a continuing need for a product with YUTREPIA's profile and strengthens our resolve to launch YUTREPIA
as soon as possible."
clarity on path to launching YUTREPIA with key legal wins. In 2020, United Therapeutics Corporation (UTC) filed litigation
in the United States District Court for the District of Delaware (the Court) under the Drug Price Competition and Patent Term Restoration
Act (Hatch-Waxman Act) that alleged Liquidia infringes U.S. Patent No. 9,593,066 ( 066 Patent), U.S. Patent No. 10,716,793
( 793 Patent) and U.S. Patent No. 9,604,901 ( 901 Patent). Since that time, the Company has demonstrated, either through
proceedings in the Court or in parallel inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB),
that each of the claims asserted by UTC against the Company is invalid or not infringed. To summarize:
Patent: In July 2022, the PTAB found in favor of Liquidia in the 793 IPR stating that all the claims of the 793
Patent have been shown to be unpatentable based on the preponderance of the evidence. While the Court in the Hatch-Waxman litigation ruled
against Liquidia based on the arguments presented at trial, finding that the 793 Patent is valid and infringed, that ruling will
be overridden by the PTAB decision in the event it is affirmed on appeal. UTC has requested a rehearing with respect to the PTAB's
decision in the 793 IPR. UTC has publicly stated that, if the rehearing request is denied, it intends to appeal the PTAB's
Patent: In August 2022, the Court ruled in Liquidia's favor with respect to the 066 Patent, finding that
five of the six asserted claims of the '066 Patent are invalid and that the remaining asserted claim is not infringed by Liquidia.
Patent: In December 2021, UTC stipulated that, based on the Court's construction of the claims in the 901
Patent, Liquidia does not infringe any of the asserted claims.
launch timing. While the decisions of the Court and the PTAB are all subject to ongoing rehearing requests and appeals, unless
UTC is successful in overturning at least one of the decisions that have been rendered, the Company will be able to launch YUTREPIA following
completion of the appeals process. Based on the current status of the various appeals and rehearing requests, it is likely that the timeline
for a prospective launch will be primarily governed by the resolution of UTC's expected appeal of the 793 IPR decision. If
the PTAB denies the rehearing request, we anticipate that the timeline for the completion of the appeal to the Court of Appeals for the
Federal Circuit could be approximately 12-14 months from the date on which the rehearing request is denied. However, in the event the
briefing schedule is accelerated, oral argument occurs earlier than expected or if the decision of the PTAB is summarily affirmed, the
appeals process may be completed within a shorter time period.
to share long-term clinical data and other studies related to YUTREPIA. Data from the completed INSPIRE study were
published in the journal Pulmonary Circulation, highlighting observations from patients treated for an average of one year.
YUTREPIA was safely dosed from 26.5 mcg to 212 mcg, which are comparable to 3 to 24 breaths of nebulized Tyvaso per session.
Patients maintained or improved in exploratory measures of clinical efficacy, whether prostacyclin na ve or transitioning from
Tyvaso. The ongoing open-label extension study will provide up to three years of long-term safety and clinical effectiveness data as
patients continue to titrate to higher doses as needed, with some patients having now reached a dose of 238.5 mcg, administered four
times daily. To that point, the Company presented data at the CHEST 2022 Annual Meeting hosted by the American College of Chest
Physicians supporting the conclusions that (i) increasing YUTREPIA dose trends with improvements in six-minute-walk-distance
(6MWD) and New York Heart Association (NYHA) Functional Class and (ii) the aerosol performance of YUTREPIA is not affected
by real-world patient misuse scenarios such as varying the inhalation orientation or dropping the device.
Quarter 2022 Financial Results
totaled $98.3 million as of September 30, 2022, compared to $57.5 million as of December 31,
was $3.2 million for the three months ended September 30, 2022, compared to $3.2
million for the three months ended September 30, 2021. Revenue related primarily to the Promotion Agreement. During the three months
ended September 30, 2022, the profit split percentage we received under the Promotion Agreement was 50%, whereas during the three
months ended September 30, 2021, the profit split percentage decreased from 80% to 50% as a result of achievement of predetermined
cumulative sales thresholds. This decrease in profit split percentage was offset by an increase in the number of units sold.
of revenue was $0.7 million for the three months ended September 30, 2022, compared
to $0.9 million for the three months ended September 30, 2021. Cost of revenue related to the Promotion Agreement as noted above.
and development expenses were $4.5 million for the three months ended September 30,
2022, compared with $4.5 million for the three months ended September 30, 2021. During the three months ended September 30,
2022, we incurred $1.5 million related to YUTREPIA compared to $1.4 million during the three months ended September 30, 2021. Research
and development expenses for the three months ended September 30, 2022 and 2021 also included personnel and consulting costs
of $2.0 million and $2.1 million, respectively, including stock-based compensation of $0.3 million in each year.
and administrative expenses were $6.7 million for the three months ended September 30,
2022, compared with $4.9 million for the three months ended September 30, 2021. The increase of $1.8 million or 38% was primarily
due to a $2.2 million increase in commercial, marketing, and personnel expenses in preparation for the potential commercialization of
YUTREPIA offset by a $0.9 million decrease in legal fees related to our ongoing YUTREPIA-related litigation.
Expenses net total was $0.3 million for the three months ended September 30, 2022,
compared with $0.2 million for the three months ended September 30, 2021. The increase of $0.1 million was primarily due to a $0.4
million increase in interest expense due to a higher debt balance and interest rate on our debt from the Amended and Restated Loan
and Security Agreement dated as of January 7, 2022 with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., offset by
increased interest income from higher cash and cash equivalents balances.
loss for the three months ended September 30, 2022, was $9.1 million, or $0.14 per basic and diluted share,
compared to a net loss of $7.3 million, or $0.14 per basic and diluted share, for the three months ended September 30,
Tyvaso is a registered trademark of United
Therapeutics Corporation.
About YUTREPIA (treprostinil) inhalation
YUTREPIA is an investigational, inhaled dry
powder formulation of treprostinil delivered through a proven, convenient, 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. 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 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.
Liquidia Corporation is a biopharmaceutical
company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT
Technology. The company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC. Liquidia
Technologies has developed YUTREPIA (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH).
Liquidia PAH provides the commercialization for pharmaceutical products to treat pulmonary disease, such as generic Treprostinil Injection.
For more information, please visit www.liquidia.com.
Cautionary Statements Regarding Forward-Looking
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.