Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a
biopharmaceutical company developing and commercializing specialty
products for allergy, opioid overdose, respiratory and inflammatory
disease, today announced financial results for the year ended
December 31, 2021.
“We managed to achieve all of our internal objectives for 2021,”
stated Dennis J. Carlo, Ph.D., President and Chief Executive
Officer of Adamis Pharmaceuticals. “Included among them, we began
enrolling patients in a Phase 2/3 clinical trial evaluating Tempol
as a treatment of COVID-19, resubmitted our NDA for ZIMHI and
subsequently received FDA approval.”
Product and Pipeline Updates and Other Corporate
Developments
ZIMHI
- In October 2021, the U.S. FDA approved ZIMHI TM (naloxone HCL
Injection, USP) 5 mg/0.5 mL for the treatment of opioid
overdose.
- Drug overdoses are now the leading cause of death for Americans
under age 50. Powerful synthetic opioids, like fentanyl and its
analogues, are responsible for approximately 85% of all opioid
overdose related deaths in the U.S.
- According to the Centers for Disease Control and Prevention
(CDC), drug overdoses resulted in over 100,000 deaths in the U.S.
during the 12-month period ending April 2021, which was a 29%
increase over the prior year.
- Earlier today, Adamis and our U.S. commercial partner, US
WorldMeds, jointly announced the nationwide commercial launch of
ZIMHI.
SYMJEPI
- Despite the challenges posed by the pandemic and related
lockdowns, Symphony Health data indicates SYMJEPI retail scripts
increased approximately 115% and total unit sales increased
approximately 124% in 2021, compared to the same period of
2020.
- On March 21, 2022, Adamis announced a voluntary recall of
certain lots of SYMJEPI. The recall is being conducted with the
knowledge of the FDA.
- Manufacturing of SYMJEPI is on hold pending the results of an
investigation currently underway to determine the root cause. The
Company anticipates a resolution and resumption of manufacturing
after the investigation is completed and any issues are
satisfactorily addressed.
TEMPOL
- In September 2021, the first patient was enrolled into the
Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment
for COVID-19. As of today, 140 patients have been enrolled in the
clinical trial.
- On March 11, 2022, the Data Safety Monitoring Board (DSMB)
overseeing the Tempol trial met to evaluate the clinical and safety
data from the first planned interim analysis. Following their
evaluation, the DSMB recommended that the study continue without
modification.
- In addition to the work in COVID, the Company is exploring
additional indications for the use of Tempol including, but not
limited to the treatment of asthma, long COVID and methamphetamine
use disorder.
US COMPOUNDING
- During July 2021, the Company sold assets relating to its US
Compounding human compounding pharmacy business. Adamis expects to
receive monthly payments over a 12-month period in an amount equal
to one to two times the amount collected for sales of products to
certain identified customers included in the sale.
- The Company is continuing a process of selling or otherwise
disposing of the remaining assets of US Compounding.
Financial Results
Despite the significant increase in retail scripts for, and unit
sales of, SYMJEPI in 2021 compared to 2020, reported net revenues
from continuing operations for the year ending December 31, 2021
were $2.2 million compared to $2.8 million in 2020, reflecting the
effect and impact of a $2.0 million reserve reflected in the
Company’s financial statements related to the SYMJEPI recall.
As a result of the SYMJEPI voluntary recall in March, we have
reserved approximately $2.0 million as a reduction of revenue for
the year ended 2021. The company may recover some or all of the
cost of the recall from certain third parties under the terms our
manufacturing agreements, but the amount of the cost and recovery
cannot be determined at this time.
Selling, general and administrative expenses for the years
ending December 31, 2021 and 2020 were $16.1 million and $20.1
million, respectively. The decrease was primarily attributable to
the reduction in expenses related to legal, compensation related to
employee terminations, including forfeitures of stock compensation,
and depreciation and amortization.
Research and development expenses were approximately $11.3
million and $8.0 million for the years ending December 31, 2021 and
2020, respectively. The increase in R&D expense was primarily
due to development costs related to ZIMHI and Tempol.
Net loss from discontinued operations for the twelve months
ended December 31, 2021, and 2020 was $11.2 million and $13.5
million, respectively. The decrease in loss was primarily due to
the offset by the gain from the sale of assets.
Cash and equivalents as of December 31, 2021, totaled
approximately $23.2 million. In 2022, the Company expects to
receive additional proceeds resulting from amounts payable to
Adamis pursuant to the sale of certain of the USC assets to Fagron
and from the disposition of the remaining USC assets which includes
the land, the building, the machinery and the equipment.
Conference Call
Adamis will host a conference call and live webcast today, March
31, 2022, at 2 p.m. PT (5 p.m. ET) to discuss its financial and
operating results for the year ended December 31, 2021, as well as
provide an update on business developments and activities.
U.S. Dial-in (Toll Free): 1-877-423-9813 Toll/International
Dial-in: 1-201-689-8573 Conference ID: 13727967
A live audio webcast of the conference call will also be
available via this link. If you are unable to participate in the
live call, a replay will be available shortly after the live event.
To listen to the replay please visit the events page of the Adamis
investor relations section of the company website at
http://ir.adamispharmaceuticals.com/presentations.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
allergy, opioid overdose, respiratory and inflammatory disease. The
Company’s SYMJEPI® (epinephrine) Injection products are approved by
the FDA for use in the emergency treatment of acute allergic
reactions, including anaphylaxis. The Company’s ZIMHI™ (naloxone)
Injection product is approved for the treatment of opioid overdose.
Tempol is in development for the treatment of patients with
COVID-19 and a Phase 2/3 clinical trial is underway. For additional
information about Adamis Pharmaceuticals, please visit our website
and follow us on Twitter and LinkedIn.
Adamis Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those that express
plans, anticipation, intent, contingencies, goals, targets or
future development and/or otherwise are not statements of
historical fact. These statements relate to future events or future
results of operations, including, but not limited to the following
statements: the Company's beliefs concerning the ability of its
products and product candidates to compete successfully in the
market; the Company's beliefs concerning the safety and
effectiveness of SYMJEPI, ZIMHI or its other products and product
candidates; the Company’s ability to successfully commercialize the
products and product candidates, itself or through
commercialization partners; the timing of the commercial launch of
our ZIMHI product; future development and regulatory actions
concerning the Company’s product candidates; the Company’s beliefs
concerning the results of any future studies or clinical trials
that the Company may conduct relating to Tempol or its other
products or product candidates; the Company’s beliefs concerning
the anticipated completion dates for clinical trials; the Company’s
beliefs concerning the benefits, enforceability, and extent of
intellectual property protection afforded by patents and patent
applications that it owns or has licensed and its rights under
applicable license agreements, and its ability to enforce its
patents and other intellectual property rights against third
parties; the Company’s expectations concerning future growth;
expectations and statements about the Company’s strategies,
objectives, future goals and achievements; and other statements
concerning our future operations, activities and financial results.
We may not achieve one or more of the target future milestones or
achievements described in the press release either within the
anticipated time periods or at all. In addition, forward-looking
statements concerning our anticipated future activities assume that
we have sufficient funding to support such activities and continue
our operations and planned activities. Statements in this press
release concerning future events depend on several factors beyond
the Company's control, including the absence of unexpected
developments or delays, market conditions, and the regulatory
approval process. These statements are only predictions and involve
known and unknown risks, uncertainties, and other factors, which
may cause the Company’s actual results to be materially different
from the results anticipated by such forward-looking statements. We
cannot assess the impact of each factor 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. You should not place undue reliance on
any forward-looking statements. Further, any forward-looking
statement speaks only as of the date on which it is made, and
except as may be required by applicable law, we undertake no
obligation to update or release publicly the results of any
revisions to these forward-looking statements or to reflect events
or circumstances arising after the date of this press release.
Certain of these risks and additional risks, uncertainties, and
other factors are described in greater detail in Adamis’ filings
from time to time with the SEC, including its annual report on Form
10-K for the year ended December 31, 2021, and subsequent filings
with the SEC, which Adamis strongly urges you to read and consider,
all of which are available free of charge on the SEC's web site at
http://www.sec.gov.
Contact:
Adamis Investor Relations Robert UhlManaging DirectorICR
Westwicke 619.228.5886robert.uhl@westwicke.com
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