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Confidential Information (until released)
Liquidia Reports First
Quarter 2021 Financial Results
and Provides Corporate
the market opportunity for Treprostinil Injection by adding subcutaneous delivery
New Drug Application for LIQ861 (treprostinil) Inhalation Powder
financial position with private placement and access to new credit facility
to host webcast and conference call today at 8:30 a.m. ET
MORRISVILLE, N.C., May 13, 2021 - Liquidia
Corporation (NASDAQ: LQDA) ("Liquidia" or the "Company") today reported financial results for the quarter ended
March 31, 2021. The Company will host a webcast and conference call at 8:30 a.m. ET to discuss the first quarter financial
results and provide a corporate update.
Damian deGoa, Liquidia's Chief Executive Officer, said: "This
first quarter has been an important time of transition and re-structuring for the company as it strengthens its position and commitment
to the products and patients that we support. We believe that our renewed focus and financial discipline are essential in order for the
company to achieve its objectives in 2021 and beyond."
Enabled subcutaneous delivery of generic Treprostinil Injection,
providing lower cost option to all patients on branded Remodulin. On March 26, 2021, the U.S. Food and Drug Administration ("FDA")
cleared the 510(k) application submitted by Liquidia PAH's manufacturing partner, Chengdu Shifeng Medical Technologies LTD
("Chengdu") for the RG 3ml Medication Cartridge which is indicated for use with the CADD-MS 3 pump. It is anticipated that
Chengdu will start selling the RG 3ml Medication Cartridge in May, enabling the subcutaneous delivery of Treprostinil Injection for the
first time. Until now, Treprostinil Injection could only be delivered by intravenous administration. The availability of the new cartridge
will more than double the addressable market for Treprostinil Injection, which has been provided to patients with the same level of high-touch
support and services as the branded product but at a lower cost since 2019.
Resubmitted NDA for LIQ861 (treprostinil) Inhalation Powder for
the treatment of Pulmonary Arterial Hypertension (PAH). On May 7, 2021, the Company resubmitted its New Drug Application ("NDA")
for LIQ861 in response to the Complete Response Letter ("CRL") received in November 2020. The resubmitted NDA was informed
by discussion with FDA during a Type A meeting in January 2021 and included additional information and clarification on chemistry,
manufacturing and controls pertaining to the drug product as well as data on device biocompatibility. No additional data from clinical
trials or studies related to toxicology or clinical pharmacology was required. The Company anticipates that the FDA will classify the
resubmitted NDA, if accepted, as a Class 2 Resubmission, which would result in a six-month review cycle from the date of resubmission.
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 certain related patents at the U.S. Patent
Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office ("USPTO"). In January 2021,
the Company submitted a petition for IPR of U.S. Patent 10,716,793 (the " 793 patent"), which was added in July 2020
to the Hatch-Waxman complaint filed by United Therapeutics. A decision by the PTAB whether to institute an IPR related to the 793
patent is expected in the third quarter of 2021 and, if instituted, a decision would be expected approximately 12 months from the date
on which the IPR is instituted. A favorable decision invalidating this patent may also be considered by the court in the concurrent Hatch-Waxman
litigation. Unless the Hatch-Waxman litigation is resolved earlier, the statutory 30-month regulatory stay as a result of the Hatch-Waxman
litigation will expire in October 2022.
Confidential Information (until released)
Strengthened financial position by reducing annual net spending
and increasing available cash resources. During the course of this year, the Company has taken several actions to improve the balance
sheet as it progresses towards potential value-creating events in 2021 and 2022. Management implemented measures that reduced net annual
spending in 2021 by more than 40% compared to 2020, which included, among other measures, reducing internal staff and consulting spending,
refinancing equipment leases, and terminating development of LIQ865 to treat post-operative pain. The Company also refinanced its former
credit facility with a new facility through Silicon Valley Bank that provides interest-only payments for 24 months, eliminating more
than $10 million in required principal repayments over the next two years, while also providing access to an additional $10 million upon
the achievement of key milestones paralleling FDA review of LIQ861. Lastly, the Company raised $21.7 million in April 2021 by entering
a common stock purchase agreement with certain institutional investors led by Caligan Partners LP. At closing, David Johnson, a Partner
and Co-Founder of Caligan Partners LP, was appointed to the board of directors of Liquidia Corporation as a Class II Director and
a member of the Audit Committee.
First Quarter 2021 Financial Results
Cash totaled $53.6 million and $65.3
million as of March 31, 2021 and December 30, 2020, respectively. This cash total does not include proceeds from the private
placement of common stock in April 2021.
Revenue of $3.1 million was recognized
for the three months ended March 31, 2021 as compared to no revenue for the three months ended March 31, 2020. Revenue recognized
during 2021 related to the promotion agreement with Sandoz Inc., after the acquisition of Liquidia PAH in November 2020.
Cost of revenue was $0.7 million for
the three months ended March 30, 2021, compared to no cost of revenue for the three months ended March 31, 2020. Cost of revenue
recognized during 2021 related to the promotion agreement as noted above.
Research and development expenses
were $6.1 million for the three months ended March 31, 2021 compared with $10.8 million for the three months ended March 31,
2020, a decrease of $4.7 million or 44.1%. The decrease primarily related to lower expenses from our LIQ861 clinical program, which was
substantially completed prior to filing the NDA in April 2020, lower expenses from our LIQ865 clinical program, and lower employee
and consulting expenses.
General and administrative expenses
were $5.3 million for the three months ended March 31, 2021, compared with $3.8 million for the three months ended March 31,
2020. The increase of $1.5 million, or 39.6%, was primarily due to $2.1 million higher legal and professional fees associated with corporate
activities as well as our ongoing LIQ861-related litigation, offset by lower consulting and personnel expenses as a result of lower headcount
Confidential Information (until released)
Net loss for the quarter ended March 31,
2021 was $9.2 million, or $0.21 per basic and diluted share, compared to a net loss of $14.8 million, or $0.52
per basic and diluted share, for the quarter ended March 31, 2020.
Remodulin (treprostinil) is a registered trademark of United
Therapeutics Corporation.
CADD-MS 3 is a registered trademark of Smiths Medical ASD, Inc.
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 its commercial partner, 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 LIQ861, an inhaled dry powder formulation of treprostinil for the treatment
of PAH. Liquidia PAH provides the commercialization for rare disease pharmaceutical products, such as Treprostinil Injection. For more
information, please visit www.liquidia.com.