Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”)
today reported financial results for the full-year ended December
31, 2020. The Company will host a webcast and conference call at
8:30 a.m. ET to discuss the 2020 financial results and provide a
corporate update.
Damian deGoa, Liquidia’s Chief Executive Officer, said:
“Activity level has been high. We closed the acquisition and
integration of RareGen, LLC, now known as Liquidia PAH, LLC, which
provides a commercial presence in PAH. There have been several
changes to the Liquidia executive team, including at CEO, CFO,
Commercial and General Counsel. We are executing our response plan
to the CRL for LIQ861 with a thorough and efficient approach as
informed by our Type A meeting with the FDA in January. We also
took immediate steps to improve the balance sheet and cash spend,
which when combined with the expected positive contribution from
Treprostinil Injection sales, mean Liquidia is creating a more
solid foundation.”
Corporate Update
Formed Liquidia Corporation to develop and commercialize
treatments for pulmonary hypertension and further leverage PRINT
technology. On November 18, 2020, the Company closed the
previously announced agreement to combine RareGen, LLC (now known
as Liquidia PAH, LLC) and Liquidia Technologies, Inc. as wholly
owned operating subsidiaries under Liquidia Corporation (the
“Merger Transaction”). The new corporate entity includes
commercialization capabilities and expertise in pulmonary arterial
hypertension (PAH) in support of Treprostinil Injection, the
first-to-file generic formulation of Remodulin® (treprostinil) from
Sandoz Inc. (“Sandoz”). This also provides the initial
infrastructure needed to commercialize LIQ861. The combined entity
reinforces Liquidia’s commitment to patients in the PAH community
and the healthcare professionals who treat them.
Confirmed plan to submit response to LIQ861 CRL in
mid-2021. On November 25, 2020, the Company announced that
the U.S. Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) for the New Drug Application (NDA) for
LIQ861, an investigational inhaled dry powder formulation of
treprostinil designed using Liquidia’s PRINT® technology. As
previously announced, the CRL identified the need for additional
information and clarification on chemistry, manufacturing and
controls (CMC) data pertaining to the drug product and device
biocompatibility. A Type A meeting was conducted with the FDA in
January 2021 to confirm and clarify the items included in the CRL.
The Company intends to submit a response to the CRL to the FDA in
the middle of 2021.
Strengthened intellectual property tied to inhaled dry
powder treprostinil. On January 26, 2021, the United
States Patent and Trademark Office (USPTO) issued patent No.
10,898,494 (the “‘494 patent”) to Liquidia relating to inhaled dry
powder treprostinil. The ‘494 patent, which expires in 2037,
includes claims covering methods of treating patients with any form
of pulmonary hypertension through the inhalation of dry powder
treprostinil at doses between approximately 100 micrograms to
approximately 300 micrograms. For reference, more than 75 percent
of patients enrolled in the Company’s pivotal “INSPIRE” and
extension studies of LIQ861 have titrated to doses of 100
micrograms or greater, and results from pharmacokinetic studies
demonstrated that the 79.5 microgram dose of LIQ861 correlates with
nine breaths of Tyvaso® (54 micrograms), the maximum recommended
label dose of Tyvaso®. Currently, more than 75 patients have now
received therapy with LIQ861 for more than two years.
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 related patents at the U.S. Patent Trial and
Appeal Board (PTAB) of the USPTO. The PTAB formally instituted an
IPR in October 2020 against U.S. Patent No. 9,604,901 (the “’901
patent”) and subsequently rejected United Therapeutics’ request for
reconsideration to revoke institution of the IPR. A final written
decision determining the validity of the challenged claims of the
‘901 patent is expected by October 2021. On January 7, 2021, the
Company submitted a petition for IPR of U.S. Patent 10,716,793 (the
“‘793 patent”), which was amended to the original Hatch-Waxman
complaint filed by United Therapeutics. A decision by the PTAB to
institute the petition related to the ‘793 patent is expected in
the third quarter of 2021 and, if instituted, would conclude
approximately 12 months later. A favorable decision invalidating
these patents may be considered by the court in concurrent
Hatch-Waxman litigation.
Reduced net annual cash spending to strengthen financial
position. Over the last three months, the Company has
initiated actions to reduce net annual spending in 2021 by more
than 40% compared to 2020 spending. Some of these measures included
reducing internal staff and full-time equivalent consultants by
nearly 40%, refinancing equipment leases, reducing consultant
spending and concentrating on 2021 corporate priorities. The
Company also refinanced its existing credit facility with a
facility providing interest-only payments for 24 months, saving
more than $10 million over next two years. The total reduction in
planned expenses may be further strengthened by the potential
positive cash contribution from the profit derived from sales of
Treprostinil Injection in Liquidia PAH’s partnership with Sandoz.
As a result, the Company is well-positioned to drive value through
key events in 2021 and 2022, beyond the projected expiration of the
regulatory stay in October 2022.
Full Year 2020 Financial Results
Cash totaled $65.3 million as of December 31, 2020. There were
43.3 million shares outstanding as of December 31, 2020.
Revenue was $0.7 million for the full year of 2020, compared
with $8.1 million for the full year of 2019. The decrease was due
to the full recognition in the second quarter of 2019 of $8.1
million of deferred revenue from the Company’s Inhaled
Collaboration and Option Agreement with GlaxoSmithKline plc, for
which there was no comparable revenue in 2020. Revenue related to
sales of Treprostinil Injection under the Promotion Agreement with
Sandoz (the “Promotion Agreement”) was recognized for the period
from closing of the Merger Transaction to year end 2020.
Cost of Revenue was $0.2 million for the full year of 2020,
compared with $0.8 million for the full year of 2019. As noted
above, the decrease of $0.6 million was due to the decrease in
revenue. Cost of revenue during the full year 2020 includes sales
force costs as well as the cost of a portion of the amortization of
the intangible asset associated with the Promotion Agreement. Cost
of revenue during the full year of 2019 represents sub-licensing
fees paid to The University of North Carolina at Chapel Hill
(“UNC”) when licensing revenue is recognized by Liquidia from the
use of the intellectual property in-licensed from UNC.
Research and development expenses were $32.2 million for the
full year of 2020, compared with $40.5 million for the full year of
2019. The decrease primarily related to lower expenses from the
Company’s LIQ861 clinical program, which was substantially
completed prior to filing the NDA in April 2020, and lower expenses
from the Company’s LIQ865 clinical program.
General and administrative expenses were $27.4 million for the
full year of 2020, compared with $13.6 million for the full year of
2019. The increase was due to $4.8 million in expenses related to
the Merger Transaction, $2.4 million in legal and patent expenses
from the Company’s ongoing LIQ861-related litigation, an increase
of $5.8 million in outside consulting expenses and personnel costs,
including share-based compensation, and a one-time charge of $1.4
million associated with a reduction of headcount.
Net loss for the full year of 2020 was $59.8 million,
or $1.76 per basic and diluted share, compared to a net
loss of $47.6 million, or $2.57 per basic and diluted
share, for the full year of 2019.
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
Sandoz, Inc., 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 two product candidates: LIQ861, an
inhaled dry powder formulation of treprostinil for the treatment of
PAH, and LIQ865, an injectable, sustained-release formulation of
bupivacaine for the management of local post-operative pain for
three to five days after a procedure. Liquidia PAH provides the
commercialization for rare disease pharmaceutical products, such as
Treprostinil Injection, Sandoz Inc.’s first-to-file, generic
treprostinil for PAH.
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 anticipate submission
contents and timelines, including our potential 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
its 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 risk that
the expected benefits and synergies from the Merger Transaction are
not realized, 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.
Liquidia Corporation is headquartered in Research
Triangle Park, NC. For more information, please
visit www.liquidia.com.
Contact Information
Media & Investors:Jason AdairVice
President, Corporate Development and
Strategy919.328.4400jason.adair@liquidia.com
Liquidia CorporationSelect Balance
Sheet Data
|
|
December 31,2020 |
|
|
December 31,2019 |
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
65,316,481 |
|
|
$ |
55,796,378 |
|
Total assets |
|
$ |
99,531,760 |
|
|
$ |
68,842,067 |
|
Total liabilities |
|
$ |
28,445,922 |
|
|
$ |
33,894,520 |
|
Accumulated deficit |
|
$ |
(275,002,219 |
) |
|
$ |
(215,239,450 |
) |
Total stockholders’
equity |
|
$ |
71,085,838 |
|
|
$ |
34,947,547 |
|
Liquidia CorporationConsolidated
Statements of Operations and Comprehensive Loss
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
Net service revenue |
|
$ |
739,628 |
|
|
$ |
— |
|
Collaboration revenue |
|
|
— |
|
|
|
8,072,120 |
|
Total revenue |
|
|
739,628 |
|
|
|
8,072,120 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of net service revenue |
|
|
237,712 |
|
|
|
— |
|
Cost of collaboration revenue |
|
|
— |
|
|
|
807,192 |
|
Research and development |
|
|
32,222,393 |
|
|
|
40,491,358 |
|
General and administrative |
|
|
27,368,653 |
|
|
|
13,597,119 |
|
Total costs and expenses |
|
|
59,828,758 |
|
|
|
54,895,669 |
|
Loss from operations |
|
|
(59,089,130 |
) |
|
|
(46,823,549 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
184,359 |
|
|
|
613,716 |
|
Interest expense |
|
|
(857,998 |
) |
|
|
(1,373,622 |
) |
Total other expense, net |
|
|
(673,639 |
) |
|
|
(759,906 |
) |
Net loss and comprehensive loss |
|
$ |
(59,762,769 |
) |
|
$ |
(47,583,455 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(1.76 |
) |
|
$ |
(2.57 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
33,888,434 |
|
|
|
18,482,455 |
|
|
|
|
|
|
|
|
|
|
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