Full Press Release Details
Liquidia Corporation Reports Full Year
2023 Financial Results and Provides Corporate Update
N.C., March 13, 2024 - Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported
financial results for the full year ended December 31, 2023. The Company will host a webcast at 8:30 a.m. ET to discuss the
2023 financial results and provide a corporate update.
Roger Jeffs, Liquidia's Chief Executive Officer, said: "Based
on our success last year, we are preparing to become a full-scale commercial entity in 2024 and initiate meaningful change to the lives
of patients diagnosed with PAH and PH-ILD. Given recent favorable court decisions, we have positioned the Company to be ready for launch
of YUTREPIA in both indications following the expiration of Tyvaso's market exclusivity on March 31, 2024. Once on the market,
we are confident that the medical community will see first-hand that YUTREPIA has the potential to not only be the best in class inhaled
product, but also the prostacyclin of first choice given its convenient, low-effort delivery and wide dosing range enabled by our proprietary
of sole patent supporting injunction was affirmed in appeal proceedings at the Federal Circuit. In December 2023, the
previous ruling by the Patent Trial and Appeal Board (PTAB) that all of the claims in U.S. Patent No. 10,716,793 ( 793 Patent)
are invalid was affirmed by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit). On March 12, 2024, the Federal Circuit
rejected United Therapeutics' request for a rehearing of the ruling in December. Liquidia has submitted these Federal Circuit rulings
to Judge Andrews and requested that he set aside the injunction preventing final regulatory approval of YUTREPIA that he entered in 2022,
which is based solely on the 793 Patent.
final FDA approval of YUTREPIA to treat PAH and PH-ILD after March 31, 2024. In September 2023, the U.S. Food and
Drug Administration (FDA) accepted for review the Company's amendment to the tentatively approved new drug application (NDA) for
YUTREPIA to include the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label. The FDA
tentatively approved YUTREPIA to treat pulmonary arterial hypertension (PAH) in November 2021 and confirmed that the addition of
the PH-ILD indication would not require any new clinical studies. The FDA may grant final approval of YUTREPIA for both PAH and PH-ILD
after the new clinical investigation exclusivity granted to Tyvaso expires on March 31, 2024 and after Judge Andrews
sets aside his injunction.
industry leading portfolio for inhaled treprostinil between YUTREPIA and sustained-release program, L606. In December 2023,
the Company opened enrollment in the ASCENT study, an open-label prospective multicenter study to evaluate safety and tolerability of
YUTREPIA in patients diagnosed with PH-ILD. Liquidia plans to complete enrollment of all 60 patients in 2024 and will share interim data
at upcoming conferences. Also in December 2023, the FDA confirmed that a single Phase 3 placebo-controlled efficacy trial in PH-ILD
patients would be required to support approval of L606 for the treatment of both PAH and PH-ILD under the 505(b)(2) regulatory pathway.
The Company is preparing to initiate the global PH-ILD study by the end of 2024. In addition, an on-going, open-label study of L606 in
U.S. patients with PAH and PH-ILD is more than one-third enrolled and includes some patients who have been successfully treated with L606
for longer than one year and at doses comparable to 25 to 27 breaths of Tyvaso, four times daily.
Year 2023 Financial Results
and cash equivalents totaled $83.7 million as of December 31, 2023. In the first
week of January, Liquidia closed two transactions that brought an additional $100 million of gross proceeds into the Company. Liquidia
and an affiliate of Patient Square Capital entered into a common stock purchase agreement for the private placement of common stock that
yielded gross proceeds of approximately $75.0 million. That same week, HealthCare Royalty Partners (HCRx) and Liquidia entered a fourth
amendment to the Revenue Interest Financing Agreement (RIFA) to fund an additional $25.0 million. HCRx has now invested $67.5 million
in non-dilutive capital from the $100 million originally contemplated from four tranches under the RIFA.
was $17.5 million for the year ended December 31, 2023, compared with $15.9 million for the
year ended December 31, 2022. Revenue related primarily to the sale of Treprostinil Injection under the Promotion Agreement with
Sandoz Inc. The increase of $1.6 million was primarily due to favorable gross-to-net chargeback, rebate, and managed care adjustments
offset by the impact of lower sales quantities as compared to the prior year.
of revenue was $2.9 million for both the year ended December 31, 2023 and the year
ended December 31, 2022. Cost of revenue related to the Promotion Agreement as noted above. During the fourth quarter of 2024 our
sales force expanded in size, however, this increase was offset by a decrease in amortization.
and development expenses were $43.2 million for the year ended December 31, 2023
compared with $19.4 million for the year ended December 31, 2022. The increase of $23.8 million or 122% was driven largely by the
$10.0 million upfront license fee payment to Pharmosa for the exclusive license in North America to develop and commercialize L606. We
incurred an additional $2.6 million in expenses related to our L606 program during the year ended December 31, 2023. Expenses related
to our YUTREPIA program increased by $6.3 million from $6.7 million during the year ended December 31, 2022 to $13.0 million during
the year ended December 31, 2023 primarily due to increased manufacturing activities related to pre-launch commercial supply and
the startup of our ASCENT study during 2023. Personnel and consulting expenses, including stock compensation expense, increased $5.1 million
primarily due to increased headcount to support the potential commercialization of YUTREPIA.
and administrative expenses were $44.7 million for the year ended December 31, 2023,
compared with $32.4 million for the year ended December 31, 2022. The increase of $12.3 million or 38% was primarily due to a $9.8
million increase in personnel and consulting expenses, including stock-based compensation, and a $1.4 million increase in commercial expenses
in preparation for the potential commercialization of YUTREPIA.
other expense, net was $5.1 million for the year ended December 31, 2023, compared
with $2.2 million for the year ended December 31, 2022. The increase of $2.9 million was primarily due to a $3.9 million increase
in interest expense attributable to the higher borrowings under the RIFA as compared to balances outstanding under the Amended and Restated
Loan and Security Agreement with Silicon Valley Bank (A&R SVB LSA) and a $1.3 million increase in loss on extinguishment of debt due
offset by a $2.4 million increase in interest income attributable to higher money market yields. The year ended December 31, 2023
included a $2.3 million loss on extinguishment of debt related to repayment of the A&R SVB LSA in January 2023. The year ended
December 31, 2022 included a $1.0 million loss on extinguishment of debt related to the refinance of our long-term debt with SVB
loss for the year ended December 31, 2023 was $78.5 million, or $1.21 per basic
and diluted share, as compared to a net loss of $41.0 million, or $0.67 per basic and diluted share, for the year ended December 31,
About YUTREPIA (treprostinil) inhalation
YUTREPIA is 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 New Drug Application for YUTREPIA, seeking to add PH-ILD to the label. 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.
Tyvaso is a registered trademark
of United Therapeutics Corporation.
About L606 (liposomal treprostinil) inhalation
L606 is an 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 PAH and PH-ILD with a planned pivotal study for
the treatment of PH-ILD.
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 pulmonary arterial hypertension (PAH)
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.