Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”)
today reported financial results for the first quarter ended March
31, 2022. The Company will host a webcast and conference call at
8:30 a.m. ET to discuss the first quarter 2022 financial results
and provide a corporate update.
Roger Jeffs, Liquidia’s Chief Executive Officer, said: “Over the
last quarter, the Company has continued to build a strong position
clinically, commercially, and financially. Clinically, our patient
experience continues to expand as we have now accrued more than 280
patient years of exposure with YUTREPIA (treprostinil) inhalation
powder in our ongoing open-label study, supporting that YUTREPIA
can be a durable treatment option for PAH patients. We remain
confident in our ability to navigate our way to final FDA approval
of YUTREPIA following our arguments presented at trial in
Hatch-Waxman proceedings in March and the arguments we will make as
part of the inter partes review at the Patent Trial Appeal Board
this week. Commercially, we continue to increase the utilization of
Treprostinil Injection with growing support from payers. And
financially, as we prepare for a potential launch of YUTREPIA later
this year, we fortified our balance sheet to support growing
commercial, clinical and pipeline activities and continue to build
an experienced and passionate team that is prepared to fulfill the
unmet needs of patients seeking better treatment options.”
Corporate Updates
Secured access to additional capital through
restructured debt and equity transactions to support
commercialization and pipeline activity. 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 during the first
quarter of 2022. On April 18, 2022, the Company closed on the sale
of 11,274,510 shares of common stock in an underwritten registered
public offering at an offering price of $5.10 per share with 19% of
shares sold to Company insiders. Net proceeds of approximately
$53.7 million were received after deducting the underwriting
discounts and commissions and other offering expenses. The total
cash on-hand enables the Company to launch YUTREPIA pending final
FDA approval, initiate new clinical trials, including for WHO Group
3 patients, and advance its pre-clinical pipeline.
Drove increased utilization of Treprostinil Injection
with increasing support of payer mandates. Liquidia’s
revenue increased slightly to $3.5 million in the first quarter
2022 as compared to $3.1 million in first quarter 2021 despite a
decrease in the profit split percentage from 80% to 50% per the
terms of the promotion agreement with Sandoz. The increase in the
number of units sold was driven largely by the implementation of
payer mandates at national and regional levels to use generic
treprostinil formulations over branded Remodulin® (treprostinil).
Additional payers are expected to implement generic mandates in the
second half of 2022 and into 2023.
Progressed legal proceedings to allow for final approval
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). Trial proceedings were held from March 28-31, 2022, and
the Court set a post-trial briefing schedule to be concluded on
June 15, 2022. The Company currently expects that a decision
regarding the Hatch-Waxman litigation will be issued prior to the
expiration of the 30-month regulatory stay in October 2022. At
trial, the Company presented evidence of non-infringement and
invalidity with respect to both the ’066 patent and the ‘793
patent, the two patents that remain at issue in the litigation. The
‘901 patent was withdrawn from litigation when UTC stipulated
Liquidia’s non-infringement in December 2021. Concurrently, the
U.S. Patent Trial and Appeal Board (PTAB) instituted an inter
partes review (IPR) of the ‘793 Patent, finding that the Company
had demonstrated a reasonable likelihood that it would prevail with
respect to showing that at least one challenged claim of the ‘793
patent is unpatentable as obvious over the combination of certain
prior art cited by the Company in its petition to the PTAB. A
hearing before the PTAB will be held on May 13, 2022, and a final
written decision determining the validity of the challenged claims
of the ‘793 patent is expected in August 2022.
First Quarter 2022 Financial Results
Cash totaled $57.8 million as of March 31, 2022. On April 18,
2022, the Company received net proceeds of approximately $53.7
million from the sale of the common stock after deducting the
underwriting discounts and commissions and other offering expenses
related to the registered public offering.
Revenue was $3.5 million for the three months ended March 31,
2022, compared to $3.1 million for the three months ended March 31,
2021. Revenue related primarily to the Promotion Agreement. During
the three months ended March 31, 2021, the profit split percentage
the Company received under the Promotion Agreement was 80%, whereas
during the three months ended March 31, 2022, the profit split
percentage was 50%. This decrease in profit split percentage was
offset by an increase in the number of units sold.
Cost of revenue was $0.7 million for the three months ended
March 31, 2022, compared to $0.7 million for the three months ended
March 31, 2021. Cost of revenue related to the Promotion Agreement
as noted above.
Research and development expenses were $4.7 million for the
three months ended March 31, 2022, compared with $6.1 million for
the three months ended March 31, 2021. The decrease of $1.4 million
or 21.9% was primarily due to the timing of manufacturing related
to our YUTREPIA program. During the three months ended March 31,
2022, the Company incurred $1.6 million in expenses related to
YUTREPIA compared to $2.7 million during the three months ended
March 31, 2021.
General and administrative expenses were $12.5 million for the
three months ended March 31, 2022, compared with $5.3 million for
the three months ended March 31, 2021. The increase of $7.2 million
or 135.0% was primarily due to a $3.3 million increase in
stock-based compensation expense driven by a $2.9 million option
modification charge during the three months ended March 31, 2022,
as well as a $3.4 million increase in legal fees related to our
ongoing YUTREPIA-related litigation.
Other Expenses totaled $1.5 million for the three months ended
March 31, 2022, compared with $0.2 million for the three months
ended March 31, 2021. The increase of $1.3 million was primarily
due to a $1.0 million loss on extinguishment of debt related to the
refinance of our long-term debt for the three months ended March
31, 2022.
Net loss for the three months ended March 31, 2022,
was $15.9 million, or $0.30 per basic and diluted
share, compared to a net loss of $9.2 million, or $0.21
per basic and diluted share, for the three months ended March 31,
2021.
Remodulin® (treprostinil) is a registered trademark of United
Therapeutics Corporation.
About YUTREPIA™(treprostinil) inhalation
powderYUTREPIA 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 naïve to inhaled
treprostinil or who are transitioning from Tyvaso (nebulized
treprostinil). YUTREPIA was previously referred to as LIQ861 in
investigational studies.
About Treprostinil InjectionTreprostinil
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 CorporationLiquidia
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
Statements 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. Such forward-looking statements, including statements
regarding clinical trials, clinical studies and other clinical work
(including the funding therefor, anticipated patient enrollment,
safety data, study data, trial outcomes, timing or associated
costs), regulatory applications and related submission contents and
timelines, including the potential for final FDA approval
of the NDA for YUTREPIA, the timeline or outcome related to our
patent litigation pending in the U.S. District Court for the
District of Delaware or our inter partes review with
the PTAB or any related appeals, the issuance of patents by the
USPTO and our ability to execute on our strategic or financial
initiatives, involve significant risks and uncertainties and actual
results could differ materially from those expressed or implied
herein. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “would,” and similar
expressions are intended to identify forward-looking statements. We
have based these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our financial condition, results
of operations, business strategy, short-term and long-term business
operations and objectives and financial needs. These
forward-looking statements are subject to a number of risks
discussed in our filings with the SEC, including the impact of
the coronavirus (COVID-19) pandemic on our Company and our
financial condition and results of operations, as well as a number
of uncertainties and assumptions. Moreover, we operate in a very
competitive and rapidly changing environment and our industry has
inherent risks. New risks emerge from time to time. It is not
possible for our management to predict all risks, nor can we assess
the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements we may make. In light of these risks, uncertainties and
assumptions, the future events discussed in this press release may
not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking
statements. Nothing in this press release should be regarded as a
representation by any person that these goals will be achieved, and
we undertake no duty to update our goals or to update or alter any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact Information for Media &
InvestorsJason AdairSenior Vice President, Corporate
Development and Strategy919.328.4400jason.adair@liquidia.com
Liquidia CorporationSelect Consolidated
Balance Sheet Data(in thousands)
|
March 31, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Cash and cash equivalents |
$ |
57,794 |
|
|
$ |
57,494 |
|
Total assets |
$ |
93,525 |
|
|
$ |
93,729 |
|
Total liabilities |
$ |
38,136 |
|
|
$ |
28,464 |
|
Accumulated deficit |
$ |
(325,524 |
) |
|
$ |
(309,581 |
) |
Total stockholders’
equity |
$ |
55,389 |
|
|
$ |
65,265 |
|
Liquidia CorporationConsolidated
Statements of Operations and Comprehensive Loss(in
thousands, except share and per share amounts)
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Revenue |
$ |
3,492 |
|
|
$ |
3,084 |
|
Costs and expenses: |
|
|
|
|
|
Cost of revenue |
|
694 |
|
|
|
694 |
|
Research and development |
|
4,728 |
|
|
|
6,054 |
|
General and administrative |
|
12,542 |
|
|
|
5,337 |
|
Total costs and expenses |
|
17,964 |
|
|
|
12,085 |
|
Loss from operations |
|
(14,472 |
) |
|
|
(9,001 |
) |
Other income (expense): |
|
|
|
|
|
Interest income |
|
4 |
|
|
|
21 |
|
Interest expense |
|
(478 |
) |
|
|
(150 |
) |
Loss on extinguishment of debt |
|
(997 |
) |
|
|
(53 |
) |
Total other income (expense), net |
|
(1,471 |
) |
|
|
(182 |
) |
Net loss and comprehensive
loss |
$ |
(15,943 |
) |
|
$ |
(9,183 |
) |
Net loss per common share,
basic and diluted |
$ |
(0.30 |
) |
|
$ |
(0.21 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
52,465,283 |
|
|
|
43,443,361 |
|
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