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.”
Corporate Update
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.
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
year-over-year.
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.
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, 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 InformationMedia &
Investors:Jason AdairVice President, Corporate Development
and Strategy919.328.4400jason.adair@liquidia.com
Liquidia CorporationSelect Balance
Sheet Data
|
March 31, 2021 |
|
|
December 31,2020 |
|
Cash |
$ |
53,637,155 |
|
|
$ |
65,316,481 |
|
Total assets |
$ |
88,451,874 |
|
|
$ |
99,531,760 |
|
Total liabilities |
$ |
25,542,695 |
|
|
$ |
28,445,922 |
|
Accumulated deficit |
$ |
(284,185,372 |
) |
|
$ |
(275,002,219 |
) |
Total stockholders’
equity |
$ |
62,909,179 |
|
|
$ |
71,085,838 |
|
Liquidia CorporationConsolidated
Statements of Operations and Comprehensive Loss
|
March 31, |
|
2021 |
|
|
2020 |
|
Revenue |
$ |
3,083,631 |
|
|
$ |
— |
|
Costs and expenses: |
|
|
|
|
|
Cost of revenue |
|
693,735 |
|
|
|
— |
|
Research and development |
|
6,053,726 |
|
|
|
10,822,924 |
|
General and administrative |
|
5,337,253 |
|
|
|
3,823,197 |
|
Total costs and expenses |
|
12,084,714 |
|
|
|
14,646,121 |
|
Loss from operations |
|
(9,001,083 |
) |
|
|
(14,646,121 |
) |
Other income (expense): |
|
|
|
|
|
Interest income |
|
20,766 |
|
|
|
109,590 |
|
Interest expense |
|
(202,836 |
) |
|
|
(254,948 |
) |
Total other income (expense), net |
|
(182,070 |
) |
|
|
(145,358 |
) |
Net loss and comprehensive
loss |
$ |
(9,183,153 |
) |
|
$ |
(14,791,479 |
) |
Net loss per common share,
basic and diluted |
$ |
(0.21 |
) |
|
$ |
(0.52 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
43,443,361 |
|
|
|
28,428,616 |
|
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