Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
financial results for the third quarter ended September 30, 2020
and provided a business update.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, stated, “We are excited to have US
WorldMeds in full control of our SYMJEPI product now that the
transition from Sandoz has been completed. We expect to see the
full impact of this transition going forward and I expect 2021 to
be the breakout year for this product. We and our commercial
partner eagerly await the FDA’s decision on our ZIMHI NDA which has
a target PDUFA date of November 15th. We remain very excited about
the remainder of this year and beyond.”
Product Updates
SYMJEPI (epinephrine) Injection
On July 1, 2020, Adamis’ new commercial partner, USWM began
promoting SYMJEPI® (epinephrine) Injection 0.3mg and
SYMJEPI® (epinephrine) Injection 0.15mg products through its
field sales force in the U.S. USWM expects to focus its sales
efforts on the high-prescribing allergists, pediatricians, and
primary care physicians. The transition of sales and distribution
from Sandoz to USWM was completed on October 31, 2020 and now USWM
is fully responsible for sales and distribution of SYMJEPI.
The company’s Australian partner, Emerge Health, which was
acquired by Chiesi Farmaceutica in June, continues to work through
the regulatory process with the Therapeutic Goods Administration
(TGA) in Australia and the company expects a decision from the TGA
sometime in the first half of 2021.
ZIMHI (naloxone) Injection
The FDA has provided a target action date (PDUFA) of November
15, 2020 with respect to the company’s resubmitted New Drug
Application (NDA) relating to ZIMHI. The company continues to work
with its commercial partner, as USWM prepares for the commercial
launch of ZIMHI.
Tempol
Since licensing this product, the company has made some progress
on the development of Tempol. Unfortunately, few therapies have
been successful so far for the treatment of COVID-19. In
preliminary results from a study in collaboration with Stanford
University, Tempol inhibits the release of multiple cytokines from
activated immune cells of COVID-19 patients. This new data now
provides the additional scientific rationale needed to conduct
clinical studies in early COVID-19 patients with Tempol. We are
currently identifying sites that could conduct this trial. With the
additional data from this study, the company continues to explore
its options for government and other forms of funding to
potentially support additional testing of Tempol.
Discussions with various groups continue to evolve on the
funding and design of a large clinical study to examine the effects
of Tempol for the treatment of radiation induced dermatitis. One of
these groups, which was previously under the direction Dr. Stephen
Hahn (current FDA commissioner), conducted successful clinical
studies of Tempol for the treatment of radiation induced
alopecia.
Drug Outsourcing Facility
Year to date, sterile and non-sterile revenues from the
company’s wholly owned drug outsourcing facility, US Compounding
(USC), were adversely affected by slowing demand due to the
COVID-19 outbreak. Revenues decreased by approximately 21% for the
nine months ended September 30, 2020, compared to the same period
in the prior year.
Third Quarter
Financial Results
Revenues were approximately $4.3 million and $5.9 million
for the three months ended September 30, 2020 and 2019,
respectively. This decrease in revenues of approximately 27% year
over year was primarily due to the COVID-19 pandemic which has
adversely affected revenues from sales of USC products, in part due
to reductions or cancellations of outpatient or
elective surgeries and other medical procedures and reductions
in office visits to physicians' offices, healthcare facilities or
clinics by patients, and the resulting decreased demand by USC’s
customers for certain of USC’s products.
Selling, general and administrative expenses for
the three months ended September 30, 2020 and 2019 were
approximately $5.8 million and $5.3 million, respectively.
Research and development expenses were approximately $1.7
million and $3.3 million for the three months ended September
30, 2020 and 2019, respectively. The decrease was primarily due to
completing work on ZIMHI and a decrease in development costs of our
other product candidates.
Cash and equivalents at the end of the third quarter was
approximately $12.4 million. This amount includes proceeds from an
equity offering completed in September which provided net proceeds
of approximately $10.7 million.
Targeted Milestones
- FDA approval and U.S. commercial launch of ZIMHI;
- Apply for government and other forms of funding for Tempol
trial in COVID-19 patients; and
- Ex-US partnerships for SYMJEPI and ZIMHI.
Conference Call
Adamis will host a conference call and live webcast
on Monday, November 9, 2020 at 2:00 pm Pacific Time to
discuss its financial and operating results for the third quarter
of 2020 as well as provide an update on business developments and
activities.
US Dial-in (Toll Free): 1-855-327-6838
TOLL/International Dial-in: 1-604-235-2082
Conference ID: 10011804
Webcast: http://public.viavid.com/index.php?id=142367
In addition, a telephone playback of the call will be available
after approximately 5:00 pm PT on November 9, 2020.
To listen to the replay, call toll free 1-844-512-2921
within the United States or 1-412-317-6671 when calling
internationally (toll). Please use the replay PIN number
10011804.
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. Adamis’ naloxone injection
product candidate, ZIMHI, for the treatment of opioid overdose is
currently under FDA review with a target action date of November
15, 2020. Adamis is developing additional products, including
treatments for acute respiratory diseases, such as COVID-19,
influenza, asthma and COPD. The company’s subsidiary, U.S.
Compounding, Inc., compounds sterile prescription drugs, and
certain nonsterile drugs for human and veterinary use by hospitals,
clinics, surgery centers, and vet clinics throughout most of the
United States.
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 impact of the COVID-19 outbreak and overall
economic outlook on the company’s present and future operations,
employees, suppliers, supply chain, manufacturers and commercial
partners; the timing and results of the FDA’s review of the
company’s resubmitted NDA for ZIMHI; the company’s beliefs
concerning the results of studies or clinical trials that the
company has conducted relating to ZIMHI or its other products or
product candidates; the company’s beliefs concerning its ability to
commercialize ZIMHI and its other products and product candidates;
the company’s beliefs concerning the success of the transition of
commercialization and marketing of its SYMJEPI products from Sandoz
to USWM; the company's beliefs concerning the ability of its
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 beliefs concerning its commercialization strategies; the
company’s beliefs concerning the anticipated timing of any
commercial launch of its ZIMHI product; the company’s beliefs
concerning the timing or outcome of discussions with the FDA or
others concerning the design and funding for trials relating to use
of Tempol as a therapeutic treatment for COVID-19 or radiation
induced dermatitis, or the timing or outcome of any such trials;
statements about strategies, objectives and our future goals and
achievements; future financial results of the company and its
subsidiaries; future development and regulatory actions concerning
the company’s product candidates; the timing and progress of
current and future clinical trials or studies; expectations and
goals for future growth, including without limitation future growth
in revenues from sales of compounded sterile pharmaceutical
formulations; anticipated commencement and completion dates for
clinical trials; product development timelines; anticipated dates
for commercial introduction of products; guidance regarding future
periods; and other statements concerning our future operations and
activities. These statements are only predictions and involve known
and unknown risks, uncertainties and other factors, which may cause
Adamis' actual results to be materially different from these
forward-looking statements. There can be no assurances concerning
the timing or outcome of future action by the FDA relating to our
resubmitted NDA for ZIMHI. In addition, there can be no assurance
that the FDA will conclude that the company’s resubmitted NDA
satisfactorily responds to the matters raised in the FDA’s previous
Complete Response Letter, that the FDA will approve our
resubmitted NDA relating to ZIMHI, or concerning the timing of any
future action by the FDA on our resubmitted NDA. The
FDA’s review processes can extend beyond, and in some cases
significantly beyond, anticipated or target completion or action
dates due to the timing of the FDA’s review process, FDA requests
for additional data, information, materials or clarification,
difficulties scheduling an advisory committee meeting, FDA workload
issues, extensions resulting from the submission of additional
information or clarification regarding information already in the
submission, issues relating to the COVID-19 pandemic, or other
reasons. We may not achieve one or more of the target future
milestones 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 are able to obtain sufficient funding to support such activities
and continue our operations and planned activities. As discussed in
our filings with the Securities and Exchange Commission, we will
require additional funding, and there are no assurances that such
funding will be available. Failure to timely obtain required
funding would adversely affect us and could require us to
materially reduce or suspend operations or one or more clinical
trials or other product development activities, or delay or prevent
our ability to realize the results contemplated by such forward
looking statements. In addition, 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, 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, 2019, and our
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. Except to
the extent required by law, any forward-looking statements in this
press release speak only as the date of this press release, and
Adamis expressly disclaims any obligation to update any
forward-looking statements.
Contacts:
Mark FlatherSenior Director, Investor Relations& Corporate
CommunicationsAdamis Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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