Full Press Release Details
Liquidia Corporation
Reports Full-Year 2021
Financial Results and
Provides Corporate Update
tentative FDA approval of YUTREPIA (treprostinil) inhalation powder
use of Treprostinil Injection to include subcutaneous administration
to launch YUTREPIA in late-2022 pending final FDA approval
to host webcast and conference call today at 8:30 a.m. ET
MORRISVILLE, N.C., March 17, 2022 - Liquidia
Corporation (NASDAQ: LQDA) ("Liquidia" or the "Company") today reported financial results for full-year ended
December 31, 2021. The Company will host a webcast and conference call at 8:30 a.m. ET to discuss the 2021 financial results
and provide a corporate update.
Roger Jeffs, Liquidia's Chief Executive Officer, said: "Last
year, we achieved every goal we set by increasing sales of Treprostinil Injection, securing tentative approval of YUTREPIA, advancing
our legal position in the ongoing Hatch-Waxman case, and strengthening our balance sheet. I am sincerely grateful for the team who has
positioned the company for its next stage of dramatic growth. We are excited about the opportunity to offer YUTREPIA to PAH patients in
2022, especially as the demand for inhaled treprostinil expands into a potential market opportunity of over $1 billion in the near future."
Completed first full year as a fully integrated, research, development,
and commercial organization with immediate focus on treating pulmonary hypertension. In November 2020, Liquidia Technologies, Inc.
and RareGen, LLC (now known as Liquidia PAH, LLC) became wholly owned operating subsidiaries of Liquidia Corporation. The new corporate
entity includes commercialization capabilities and expertise in pulmonary arterial hypertension (PAH) in support of Treprostinil Injection,
the first-to-file generic formulation of Remodulin (treprostinil) from Sandoz Inc. Strategically, the combined entity reinforced
Liquidia's commitment to PAH patients and the medical community in preparation for the launch of YUTREPIA (treprostinil)
inhalation powder upon potential final approval by the United Stated Food and Drug Administration (FDA) and favorable resolution of the
Hatch-Waxman litigation.
Received tentative FDA approval of YUTREPIA (treprostinil)
inhalation powder to treat PAH, validating the application of PRINT Technology. In November 2021, the FDA issued a tentative
approval of YUTREPIA which indicated that the New Drug Application (NDA) had met all the requirements for final approval but cannot yet
be marketed pending resolution of Hatch-Waxman litigation commenced by United Therapeutics on in June 2020. In support of the approval
decision, the FDA completed an on-site Pre-Approval Inspection of the Morrisville, North Carolina, facility over 5-days with no Form 483
Inspectional Observations issued.
Removed barriers to increase adoption of generic Treprostinil Injection
by patients, physicians, and payers. In May 2021, Liquidia PAH's manufacturing partner, Chengdu Shifeng Medical Technologies
LTD began selling the RG 3ml Medication Cartridge, which may be used to supply treprostinil to PAH patients using the CADD-MS 3 pump for
subcutaneous administration. As a result, unit sales of Treprostinil Injection increased dramatically in 2021 across intravenous and subcutaneous
routes of administration, more than doubling the number of patients being treated as compared to the first half of 2021. The Company remains
confident that the inventory of pumps and cartridges held by specialty pharmacies is sufficient to support the treatment of all PAH patients
requiring parenteral administration of Treprostinil Injection.
Continued to advance legal proceedings to allow for final approval
of YUTREPIA. In support of YUTREPIA, the Company is actively involved in Hatch-Waxman litigation brought by United Therapeutics Corporation
("UTC") in June 2020 involving three U.S. patents: No. 9,604,901 (the 901 Patent), 9,593,066
(the 066 Patent) and 10,716,793 (the 793 Patent). During 2021, Liquidia secured several favorable
legal rulings in proceedings at the District Court of Delaware and through inter partes review (IPR) at the U.S. Patent Office.
In August, the U.S. Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) against the 793 Patent, stating
that Liquidia demonstrated a reasonable likelihood of prevailing in its assertion that all of the claims of the 793 patent are
unpatentable as obvious over the combination of certain prior art cited by Liquidia in its petition to the PTAB. In October, the PTAB
found that found that seven of the nine claims in the 901 Patent were unpatentable, leaving only the narrower dependent claims
6 and 7 remaining, both of which require actual storage at ambient temperature of treprostinil sodium. In December, UTC stipulated to
Liquidia's non-infringement of the '901 Patent. Trial in the Hatch-Waxman litigation is scheduled for March 28-31, and
a final written decision in the IPR for the 793 Patent is expected in August 2022.
Strengthened the balance sheet to drive value though key legal milestones
and regulatory events. Over the year, the Company initiated actions to significantly reduce net annual spending in 2021 compared to
2020 to extend the cash runway. The cost-cutting measures were complemented by $12.9 million in revenue from the profit derived from sales
of Treprostinil Injection in Liquidia PAH's partnership with Sandoz. In January 2022, the Company increased its existing credit
facility with Silicon Valley Bank, providing access to up to $40.0 million in term loans of which the first $20.0 million was funded in
2022. The net impact of these financial measures positions the Company to drive value through key legal and regulatory events as it prepares
to launch YUTREPIA pending final FDA approval.
Year 2021 Financial Results
totaled $57.5 million as of December 31, 2021. There were 52.3 million shares outstanding as of December 31, 2021.
was $12.9 million for the year ended December 31, 2021, compared with $0.7 million for the year ended December 31, 2020. 2021
includes a full year of revenue related to the Promotion Agreement following the acquisition of Liquidia PAH in November 2020. Revenue
is net of $2.7 million in amortization of the contract acquisition costs associated with the Promotion Agreement with Sandoz.
of revenue was $3.0 million for the year ended December 31, 2021, compared with $0.2 million for the year ended December 31,
2020. 2021 includes a full year of Cost of revenue related to the Promotion Agreement following the acquisition of Liquidia PAH in November 2020
and included (i) the cost of employing a targeted sales force calling on physicians and hospital pharmacies involved in the treatment
of PAH, as well as key stakeholders involved in the distribution and reimbursement of Treprostinil Injection and (ii) amortization
of the intangible asset associated with the Promotion Agreement.
and development expenses were $20.5 million for the year ended December 31, 2021, compared with $32.2 million for the year ended
December 31, 2020, a decrease of $11.7 million or 36.3%. The decrease primarily related to lower expenses from our YUTREPIA clinical
program, which was substantially completed prior to filing the NDA in April 2020, and lower employee and consulting expenses.
and administrative expenses were $23.1 million for the year ended December 31, 2021, compared with $27.4 million for the year
ended December 31, 2020. The decrease of $4.3 million, or 15.6%, was due to a $9.1 million decrease in consulting expenses and professional
fees associated with corporate activities, a $1.1 million decrease in personnel expenses, and a $0.5 million decrease in commercial and
marketing expenses. These decreases were offset by a $5.1 million increase in legal fees related to our ongoing YUTREPIA-related litigation
and a $2.0 million increase in stock-based compensation expenses driven by the accelerated vesting of equity awards upon tentative FDA
approval of YUTREPIA in November 2021.
Net loss for during the year ended
December 31, 2021, was $34.6 million, or $0.70 per basic and diluted share, compared to a net loss of $59.8 million,
or $1.76 per basic and diluted share, for the year ended December 31, 2020.
Remodulin (treprostinil) 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 optimal 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.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical