Full Press Release Details
Corporation Reports Full-Year 2020
Results and Provides Corporate Update
RESEARCH TRIANGLE PARK, N.C., March 23, 2021 - Liquidia
Corporation (NASDAQ: LQDA) ("Liquidia" or the "Company") today reported financial results for the full-year
ended December 31, 2020. The Company will host a webcast and conference call at 8:30 a.m. ET to discuss the 2020 financial results
and provide a corporate update.
Damian deGoa, Liquidia's Chief Executive Officer, said:
"Activity level has been high. We closed the acquisition and integration of RareGen, LLC, now known as Liquidia PAH, LLC,
which provides a commercial presence in PAH. There have been several changes to the Liquidia executive team, including at CEO,
CFO, Commercial and General Counsel. We are executing our response plan to the CRL for LIQ861 with a thorough and efficient approach
as informed by our Type A meeting with the FDA in January. We also took immediate steps to improve the balance sheet and cash spend,
which when combined with the expected positive contribution from Treprostinil Injection sales, mean Liquidia is creating a more
Formed Liquidia Corporation to develop and commercialize
treatments for pulmonary hypertension and further leverage PRINT technology. On November 18, 2020, the Company closed the previously
announced agreement to combine RareGen, LLC (now known as Liquidia PAH, LLC) and Liquidia Technologies, Inc. as wholly owned operating
subsidiaries under Liquidia Corporation (the "Merger Transaction"). 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. ("Sandoz"). This also provides the initial infrastructure
needed to commercialize LIQ861. The combined entity reinforces Liquidia's commitment to patients in the PAH community and
the healthcare professionals who treat them.
Confirmed plan to submit response to LIQ861 CRL in
mid-2021. On November 25, 2020, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) for the New Drug Application (NDA) for LIQ861, an investigational inhaled dry powder formulation of
treprostinil designed using Liquidia's PRINT technology. As previously announced, the CRL identified the need for
additional information and clarification on chemistry, manufacturing and controls (CMC) data pertaining to the drug product
and device biocompatibility. A Type A meeting was conducted with the FDA in January 2021 to confirm and clarify the items
included in the CRL. The Company intends to submit a response to the CRL to the FDA in the middle of 2021.
Strengthened intellectual property tied to inhaled dry powder
treprostinil. On January 26, 2021, the United States Patent and Trademark Office (USPTO) issued patent No. 10,898,494 (the
" 494 patent") to Liquidia relating to inhaled dry powder treprostinil. The 494 patent, which expires
in 2037, includes claims covering methods of treating patients with any form of pulmonary hypertension through the inhalation of
dry powder treprostinil at doses between approximately 100 micrograms to approximately 300 micrograms. For reference, more than
75 percent of patients enrolled in the Company's pivotal "INSPIRE" and extension studies of LIQ861 have titrated
to doses of 100 micrograms or greater, and results from pharmacokinetic studies demonstrated
that the 79.5 microgram dose of LIQ861 correlates with nine breaths of Tyvaso (54 micrograms), the maximum recommended label
dose of Tyvaso . Currently, more than 75 patients have now received therapy with LIQ861 for more than two years.
Continued to defend right to advance innovation for PAH patients.
In support of LIQ861, the Company is actively involved in Hatch-Waxman litigation brought by United Therapeutics Corporation
("United Therapeutics"), as well as pursuing inter partes review (IPR) of related patents at the U.S. Patent
Trial and Appeal Board (PTAB) of the USPTO. The PTAB formally instituted an IPR in October 2020 against U.S. Patent No. 9,604,901
(the "'901 patent") and subsequently rejected United Therapeutics' request for reconsideration to revoke
institution of the IPR. A final written decision determining the validity of the challenged claims of the 901 patent is
expected by October 2021. On January 7, 2021, the Company submitted a petition for IPR of U.S. Patent 10,716,793 (the " 793
patent"), which was amended to the original Hatch-Waxman complaint filed by United Therapeutics. A decision by the PTAB to
institute the petition related to the 793 patent is expected in the third quarter of 2021 and, if instituted, would conclude
approximately 12 months later. A favorable decision invalidating these patents may be considered by the court in concurrent Hatch-Waxman
Reduced net annual cash spending to strengthen financial
position. Over the last three months, the Company has initiated actions to reduce net annual spending in 2021 by more than
40% compared to 2020 spending. Some of these measures included reducing internal staff and full-time equivalent consultants by
nearly 40%, refinancing equipment leases, reducing consultant spending and concentrating on 2021 corporate priorities. The Company
also refinanced its existing credit facility with a facility providing interest-only payments for 24 months, saving more than
$10 million over next two years. The total reduction in planned expenses may be further strengthened by the potential positive
cash contribution from the profit derived from sales of Treprostinil Injection in Liquidia PAH's partnership with Sandoz.
As a result, the Company is well-positioned to drive value through key events in 2021 and 2022, beyond the projected expiration
of the regulatory stay in October 2022.
Year 2020 Financial Results
totaled $65.3 million as of December 31, 2020. There were 43.3 million shares outstanding as of December 31, 2020.
was $0.7 million for the full year of 2020, compared with $8.1 million for the full year of 2019. The decrease was due to the full
recognition in the second quarter of 2019 of $8.1 million of deferred revenue from the Company's Inhaled Collaboration and
Option Agreement with GlaxoSmithKline plc, for which there was no comparable revenue in 2020. Revenue related to sales of Treprostinil
Injection under the Promotion Agreement with Sandoz (the "Promotion Agreement") was recognized for the period from
closing of the Merger Transaction to year end 2020.
of Revenue was $0.2 million for the full year of 2020, compared with $0.8 million for the full year of 2019. As noted above,
the decrease of $0.6 million was due to the decrease in revenue. Cost of revenue during the full year 2020 includes sales force
costs as well as the cost of a portion of the amortization of the intangible asset associated with the Promotion Agreement. Cost
of revenue during the full year of 2019 represents sub-licensing fees paid to The University of North Carolina at Chapel Hill ("UNC")
when licensing revenue is recognized by Liquidia from the use of the intellectual property in-licensed from UNC.
and development expenses were $32.2 million for the full year of 2020, compared with $40.5 million for the full year of 2019.
The decrease primarily related to lower expenses from the Company's LIQ861 clinical program, which was substantially completed
prior to filing the NDA in April 2020, and lower expenses from the Company's LIQ865 clinical program.
and administrative expenses were $27.4 million for the full year of 2020, compared with $13.6 million for the full year of
2019. The increase was due to $4.8 million in expenses related to the Merger Transaction, $2.4 million in legal and patent expenses
from the Company's ongoing LIQ861-related litigation, an increase of $5.8 million in outside consulting expenses and personnel
costs, including share-based compensation, and a one-time charge of $1.4 million associated with a reduction of headcount.
Net loss for the full year of
2020 was $59.8 million, or $1.76 per basic and diluted share, compared to a net loss of $47.6 million, or $2.57
per basic and diluted share, for the full year of 2019.
LIQ861 is an investigational
inhaled dry powder formulation of treprostinil designed using Liquidia's PRINT technology with the goal of
enhancing deep-lung delivery using a convenient, palm-sized dry powder inhaler for the treatment of pulmonary arterial
hypertension (PAH). PRINT technology 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
believes LIQ861 can overcome the limitations of current inhaled therapies and has the potential to maximize the therapeutic
benefits of treprostinil in treating PAH by safely delivering higher doses into the lungs. Liquidia has completed an
open-label, multi-center phase 3 clinical study of LIQ861 in patients diagnosed with PAH known as INSPIRE, or Investigation
of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil.
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 Sandoz, Inc., who holds the Abbreviated
New Drug Application (ANDA) with the FDA.
About Liquidia Corporation
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 is developing two product candidates: LIQ861, an inhaled dry powder formulation
of treprostinil for the treatment of PAH, and LIQ865, an injectable, sustained-release formulation of bupivacaine for the management
of local post-operative pain for three to five days after a procedure. Liquidia PAH provides the commercialization for rare disease
pharmaceutical products, such as Treprostinil Injection, Sandoz Inc.'s first-to-file, generic treprostinil for PAH.