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 nine months
ended September 30, 2021 and provided a business update.
“Adamis made significant advancements over the past year,”
stated Dennis J. Carlo, Ph.D., President and Chief Executive
Officer of Adamis Pharmaceuticals. “We resubmitted our NDA for
ZIMHI to the FDA. We initiated and began enrolling patients in a
Phase 2/3 clinical trial to evaluate the use of Tempol for the
treatment of COVID-19. Under our new commercial partner, we have
seen significant sales growth for SYMJEPI. Most significantly, in
October we received an early approval for ZIMHI for the treatment
of opioid overdose and commercial introduction is expected during
the first quarter of 2022.”
Product and Pipeline Updates and Other Corporate
Developments
ZIMHI
- On October 18, 2021, Adamis announced that the U.S. FDA had
approved the Company’s ZIMHI TM (naloxone HCL Injection, USP) 5
mg/0.5 mL product.
- ZIMHI is a high-dose naloxone injection product FDA-approved
for use in the treatment of opioid overdose.
- According to the preliminary data from the CDC, overdose deaths
in the U.S. exceeded 100,000 for the twelve months ending April
2021.
- The Company’s U.S. commercial partner, US WorldMeds is
preparing to commercially launch ZIMHI in the first quarter of
2022.
SYMJEPI
- In October 2020, US WorldMeds completed the transition of
control of the commercial operations of SYMJEPI from Sandoz,
Inc.
- The U.S. market for epinephrine exceeded $1.7 billion in annual
sales for the 12-month period ending September 30, 2021, according
to Symphony Health market data.
- Despite the marketing challenges posed by the pandemic and
related lockdowns, Symphony Health data indicates SYMJEPI unit
sales increased approximately 98% for nine months ending September
30, 2021, versus the first nine months of 2020.
TEMPOL
- Tempol has been shown to have antiviral, anti-inflammatory and
antioxidant activity.
- Recently, the National Institutes of Health (NIH) highlighted
Tempol as a potential home treatment for COVID-19.
- In September, the first patient was enrolled into the Company’s
ongoing Phase 2/3 clinical trial of Tempol as a treatment for
COVID-19 and the Company is expanding the number of clinical study
sites, including several potential sites outside the U.S.
- Adamis licensed exclusive worldwide rights under patents,
patent applications and related know-how relating to Tempol for
certain licensed fields including the treatment of respiratory
diseases including asthma, respiratory syncytial virus infection,
influenza and COVID-19.
- 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 methamphetamine use disorder.
US COMPOUNDING
- In July 2021, the Company sold assets relating to its US
Compounding human compounding pharmacy business. Under the terms of
the sale, the Company 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.
- By the end of October, USC had ceased manufacturing both human
and veterinary pharmaceutical products and the employment of all
USC employees has ended.
- The Company is now engaged in a process of selling or otherwise
disposing of the remaining assets of the business.
Financial Results
The business conducted through our USC subsidiary is treated as
a discontinued operation as of September 30, 2021. Accordingly, for
this period the major current assets, other assets, current
liabilities, and noncurrent liabilities have been reported as
components of total assets and liabilities separate from those
balances of the continuing company operations. At the same time,
the results of all discontinued operations have been reported as
components of net loss separate from the net loss of continuing
operations. Additionally, the financial statements of the
comparable prior periods were reflected in conformity with the
current period’s presentation as discontinued operations.
Reflecting these discontinued operations accounting principles,
revenues for the nine months ended September 30, 2021 and 2020 were
approximately $3.4 million and $2.1 million, respectively. The
increase in revenue was primarily attributable to US WorldMeds’
marketing initiatives for SYMJEPI.
Selling, general and administrative expenses for the nine
months ending September 30, 2021 and 2020 were approximately $13.2
million and $9.6 million, respectively. The increase was primarily
attributable to an increase in legal fees.
Research and development expenses were approximately $9.1
million and $6.6 million for the nine months ending September 30,
2021 and 2020, respectively. The increase was primarily due to
development related to ZIMHI and Tempol.
Cash and equivalents as of September 30, 2021 was approximately
$28.7 million. Based on the operating capital that Adamis provided
to USC over the last four quarters, we estimate the shutdown of the
USC business may reduce those cash expenditures by approximately
$1.2 million per quarter starting in the fourth quarter of 2021,
excluding expenses associated with the winding down of USC’s
business. Additionally, over the next four quarters, the Company
estimates to receive additional cash amounts relating to the sale
of certain USC assets.
Conference Call
Adamis will host a conference call and live webcast today,
November 22, 2021, at 2 p.m. PT (5 p.m. ET) to discuss its
financial and operating results for the nine months ending
September 30, 2021, as well as provide an update on business
developments and activities.
U.S. Dial-in (Toll Free): 1-877-423-9813Toll/International
Dial-in: 1-201-689-8573Conference ID: 13725311
A live audio webcast of the conference call will also be
available via this link –
https://viavid.webcasts.com/starthere.jsp?ei=1515468&tp_key=857fdc0361.
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 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
www.adamispharmaceuticals.com and follow us on 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, 2020, 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:
Investor Relations atAdamis Pharmaceuticals Corporation (858)
997-2400 option 3IR@adamispharma.com
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