Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”)
today reported financial results for the quarter and nine-months
ended September 30, 2021.
Damian deGoa, Liquidia’s Chief Executive Officer, said: “We had
another productive quarter. Sales performance of Treprostinil
Injection was ahead of target. The initial uptake has been very
positive as patients continue to transition to, or start on,
Treprostinil Injection with clear support from payers and
healthcare providers. We also had positive developments in our
ongoing litigation with United Therapeutics. We look forward to
hearing from the FDA in the coming days about the potential
tentative approval of LIQ861.”
Corporate Updates
Increased adoption of generic Treprostinil Injection by
patients, physicians and payers. During the third quarter,
unit sales of Treprostinil Injection increased across intravenous
and subcutaneous routes of administration, more than doubling the
number of patients being treated as compared to the number of
patients prior to the launch of the subcutaneous route of
administration in late May of 2021. Revenue was impacted by a
reduction in the contractual profit split percentage earned
pursuant to the Promotion Agreement between Liquidia PAH and Sandoz
as a result of achievement of pre-determined cumulative sales
thresholds. As a result, the increase in unit sales did not result
in a corresponding increase in revenue reflected on the income
statement on a quarter-over-quarter basis.
Completed on-site pre-approval inspections by FDA of two
U.S. manufacturing facilities in advance of LIQ861 PDUFA goal
date. As part of the FDA review of LIQ861, the FDA
conducted two prior-approval inspections, one at the Company’s
Morrisville, NC facility and the other at the facility of a
third-party provider of encapsulation and packaging services for
LIQ861. These pre-approval inspections were completed in August
2021 and October 2021, respectively.
Successfully advanced inter
partes review (IPR) proceedings against two
patents owned by United Therapeutics (UTC) being asserted in
related Hatch-Waxman litigation. In August 2021, the U.S.
Patent Trial and Appeal Board (PTAB) instituted an IPR against U.S.
Patent No. 10,716,793 (‘793 patent) owned by UTC. In its decision,
the PTAB stated that Liquidia had 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. A
final written decision determining the validity of the challenged
claims of the ‘793 patent is expected within 12 months from
institution.
More recently in October 2021, the PTAB ruled in Liquidia’s
favor in the IPR proceeding against U.S. Patent No. 9,604,901 (‘901
patent). In its ruling, the PTAB found that seven of the nine
claims were unpatentable. Only the narrower dependent claims 6 and
7 remain, both of which require actual storage at ambient
temperature of treprostinil sodium.
The ‘901 and ‘793 patents, along with U.S. Patent No. 9,593,066
(‘066 patent), are the subject of Hatch-Waxman litigation filed by
UTC in June 2020. The trial is expected in March 2022 in U.S.
District Court for the District of Delaware. As a result of this
litigation, the FDA is automatically precluded from fully approving
the LIQ861 NDA until October 2022 absent an earlier judgment
unfavorable to United Therapeutics by the court or other
settlement.
Third Quarter 2021 Financial Results
Cash totaled $64.1 million and $65.3 million as of September 30,
2021, and December 30, 2020, respectively.
Revenue of $3.2 million was recognized for the three months
ended September 30, 2021, as compared to no revenue for the three
months ended September 30, 2020. Revenue recognized during 2021
related primarily to the promotion agreement with Sandoz Inc.,
after the acquisition of Liquidia PAH in November 2020.
Cost of revenue was $0.9 million for the three months ended
September 30, 2021, compared to no cost of revenue for the three
months ended September 30, 2020. Cost of revenue recognized during
2021 related to the promotion agreement as noted above.
Research and development expenses were $4.5 million for the
three months ended September 30, 2021, compared with $7.7 million
for the three months ended September 30, 2020, a decrease of $3.2
million or 41.4%. The decrease primarily related to lower expenses
from the LIQ861 clinical program as well as lower employee and
consulting expenses.
General and administrative expenses were $4.9 million for the
three months ended September 30, 2021, compared with $7.2 million
for the three months ended September 30, 2020. The decrease of $2.3
million or 31.7% was primarily due to $2.9 million lower consulting
expenses and professional fees associated with corporate activities
offset by a $0.6 million increase in legal fees related to the
ongoing LIQ861-related litigation.
Net loss for the quarter ended September 30, 2021, was $7.3
million, or $0.14 per basic and diluted share, compared
to a net loss of $15.0 million, or $0.40 per basic and
diluted share, for the quarter ended September 30,
2020.
Remodulin® (treprostinil) is a registered trademark of United
Therapeutics Corporation.
About LIQ861LIQ861 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 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 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.
Cautionary Statements Regarding Forward-Looking
StatementsThis 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 our response to the Complete Response Letter
received in November 2020, the potential for
eventual FDA approval of the NDA for LIQ861, 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)
outbreak 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
Media & Investors:Jason AdairVice
President, Corporate Development and
Strategy919.328.4400jason.adair@liquidia.com
Liquidia CorporationSelect Balance
Sheet Data
|
|
September 30, 2021 |
|
|
December 31,2020 |
|
Cash |
|
$ |
64,053,795 |
|
|
|
$ |
65,316,481 |
|
Total assets |
|
$ |
100,299,409 |
|
|
|
$ |
99,531,760 |
|
Total liabilities |
|
$ |
27,335,398 |
|
|
|
$ |
28,445,922 |
|
Accumulated deficit |
|
$ |
(298,017,750 |
) |
|
|
$ |
(275,002,219 |
) |
Total stockholders’
equity |
|
$ |
72,764,011 |
|
|
|
$ |
71,085,838 |
|
|
|
|
|
|
|
|
|
|
|
Liquidia CorporationConsolidated
Statements of Operations and Comprehensive Loss
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue |
|
$ |
3,178,621 |
|
|
$ |
— |
|
|
$ |
9,638,338 |
|
|
$ |
— |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
889,511 |
|
|
|
— |
|
|
|
2,296,983 |
|
|
|
— |
|
Research and development |
|
|
4,487,098 |
|
|
|
7,660,979 |
|
|
|
15,136,201 |
|
|
|
26,974,320 |
|
General and administrative |
|
|
4,881,669 |
|
|
|
7,151,788 |
|
|
|
14,639,752 |
|
|
|
16,201,249 |
|
Total costs and expenses |
|
|
10,258,278 |
|
|
|
14,812,767 |
|
|
|
32,072,936 |
|
|
|
43,175,569 |
|
Loss from operations |
|
|
(7,079,657 |
) |
|
|
(14,812,767 |
) |
|
|
(22,434,598 |
) |
|
|
(43,175,569 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,875 |
|
|
|
34,633 |
|
|
|
29,521 |
|
|
|
155,852 |
|
Interest expense |
|
|
(205,110 |
) |
|
|
(190,546 |
) |
|
|
(610,454 |
) |
|
|
(656,543 |
) |
Total other income (expense), net |
|
|
(201,235 |
) |
|
|
(155,913 |
) |
|
|
(580,933 |
) |
|
|
(500,691 |
) |
Net loss and comprehensive
loss |
|
$ |
(7,280,892 |
) |
|
$ |
(14,968,680 |
) |
|
$ |
(23,015,531 |
) |
|
$ |
(43,676,260 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.14 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.38 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
52,081,497 |
|
|
|
37,755,472 |
|
|
|
48,822,303 |
|
|
|
31,576,992 |
|
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