Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
financial results for the year ended December 31, 2019 and provided
a business update.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, stated, “In light of the recent COVID-19
outbreak and overall economic outlook, we have attempted to
determine the impact of the outbreak on our present and future
operations, including the impact on our suppliers, manufacturers
and commercial partners. The good news is that at the present time
we have not seen a material impact of COVID-19 on demand for our
products, and we have not yet seen any significant negative impact
on our supply chain or distribution network. If the outbreak
appreciably worsens and/or if governmental restrictions persist for
a protracted period, that could of course affect our outlook.”
“Having said that, the outbreak and governmental mandated social
distancing and sheltering in place have caused some near-term
impact and disruption to our employees and daily operations.
For that reason, and to allow some time to gain additional
visibility into the 2020 year, we have determined to postpone our
regularly scheduled earnings conference call. My sincere hope
is that we can have a more meaningful call in the future and
provide a clearer picture of the remainder of 2020 and the outlook
for the company.”
“In the meantime, we remained focused on completing the
additional work to allow us to supplement our NDA for our naloxone
injection product (ZIMHI). We are actively addressing the
issues the FDA raised in the Complete Response Letter we received
late last year. We continue to believe ZIMHI can play an important
role in combating the ongoing public health crisis of opioid
overdose, and we look forward to the eventual approval of ZIMHI.
SYMJEPI sales continue to be far lower than we ever expected.
We are currently working with Sandoz to determine what needs to
occur to accelerate its growth in the epinephrine market. Sales of
pharmaceutical preparations through our US Compounding drug
outsourcing facility had strong growth for 2019 versus the year
prior.”
Product Updates
SYMJEPI (epinephrine) Injection
On January 16, 2019, we announced that Sandoz had launched
SYMJEPI (epinephrine) 0.3 mg Injection in the U.S. market,
initially available in the institutional setting. On July 9, 2019,
we announced the full launch (institutional and retail) by Sandoz
of both dose forms of the SYMJEPI injection products.
In addition to the U.S., Adamis continues to seek opportunities
to market SYMJEPI into other territories. On October 1, 2019, the
company announced it had entered into an exclusive distribution and
commercialization agreement with Emerge Health to seek registration
and commercialize SYMJEPI in both Australia and New Zealand.
ZIMHI (naloxone) Injection
On November 22, 2019, the company received a Complete
Response Letter (CRL) from the U.S. Food and Drug
Administration (FDA) regarding the company’s New Drug
Application (NDA) relating to its ZIMHI high-dose naloxone
injection product for the treatment of opioid overdose. On December
19, 2019, Adamis provided an update indicating that it had provided
responses to the comments included in the CRL and submitted them to
the FDA along with a request for a meeting. On February
12, 2020, the Company had a Type A meeting with the FDA to discuss
the company’s response to the CRL and the process and timeline for
resubmission of the NDA to the FDA. At the meeting, Adamis obtained
concurrence from the agency on the information required for
resubmission of the NDA.
The company believes it can generate the additional data, and
assuming successful testing, resubmit the NDA in the second quarter
of 2020. The FDA expressed its intent to review the resubmission in
a rapid and timely manner consistent with agency guidelines. The
company continues to have discussions with potential commercial
partners for ZIMHI.
Drug Outsourcing Facility
During the fourth quarter of 2019, the company’s wholly owned
drug outsourcing facility, US Compounding (USC), continued to grow
its revenues by approximately 13% in the fourth quarter compared to
the same quarter in the prior year. For the year, USC increased
revenues approximately 22% versus 2018. USC’s increase in revenues
was due to the increase in sales of USC’s sterile pharmaceutical
formulations resulting in part from an increase in production
capacity in order to meet product demand and from increasing sales
and marketing efforts.
2019 Financial Results
Adamis total revenues increased approximately 47%, from $15.1
million to $22.1 million, for the year ended December 31, 2018 and
2019, respectively. Total revenues increased by approximately
33%, to $5.5 million from $4.2 million fourth quarter of 2019
compared to the same period in 2018. The increase was
primarily attributable to growth in sales of USC’s sterile
pharmaceutical products and revenue relating to SYMJEPI.
Selling, general and administrative expenses (“SG&A”)
for the years ending December 31, 2019 and 2018 were approximately
$25.3 million and $26.0 million, respectively, a decrease of
approximately 3%. The decrease was primarily attributable to
decreases of approximately $2.1 million in compensation expenses,
occupancy costs, and other related expenses. These amounts were
partially offset by an increase of approximately $1.4 million
attributable to increases in consulting, legal, patent, insurance,
PDUFA fees, marketing and selling expenses.
Research and development expenses were approximately $10.4
million and $18.8 million for the years ended December 31, 2019 and
2018, respectively, a decrease of approximately 45%. The decrease
was primarily due to a decrease in development costs of our
product candidates.
Cash and equivalents at the end of the year was approximately
$8.8 million. In February, the Company increased its cash
position by raising approximately $6.7 million before deducting the
placement agent’s fees and other estimated offering expenses, in an
equity financing transaction. The net loss for the year was
approximately $29.3 million.
Targeted Milestones
- Increasing sales of SYMJEPI in the U.S.;
- Resubmission of New Drug Application for ZIMHI;
- FDA approval and commercial partner for ZIMHI;
- Following FDA approval, begin selling ZIMHI in the U.S.;
- Increasing sales and margins at US Compounding; and
- Completing a Phase III ulcer study in horses.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
respiratory disease, allergy and opioid overdose. The
company’s SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI
(epinephrine) Injection 0.15mg products were approved by the FDA
for use in the emergency treatment of acute allergic reactions,
including anaphylaxis. In July 2019, Sandoz, a division of
Novartis Group, announced it had fully launched both in the
U.S. Please refer to www.SYMJEPI.com for additional
product information. Adamis is developing additional
products, including a naloxone injection product candidate, ZIMHI,
for the treatment of opioid overdose, and a metered dose inhaler
and dry powder inhaler product candidates for the treatment of
asthma and COPD. The company’s subsidiary, U.S. Compounding,
Inc., compounds sterile prescription drugs, and certain nonsterile
drugs for use by hospitals, clinics and surgery centers 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 recent COVID-19 outbreak
and overall economic outlook on the company’s present and future
operations, employees, suppliers, supply chain, manufacturers and
commercial partners; the company’s beliefs concerning its ability
to satisfactorily respond to the matters raised in the FDA’s
Complete Response Letter (CRL) and to successfully develop the
additional information requested by the FDA at the company’s Type A
meeting with the FDA; the results of the company’s Type A meeting
with the FDA; the company’s beliefs concerning the results of
any future studies or clinical trials that the company may conduct
relating to ZIMHI or its other products or product candidates; the
company’s beliefs concerning the information and activities
required to resubmit the ZIMHI New Drug Application (NDA) to the
FDA, the timing of resubmission of the company’s NDA to
the FDA and the timing and outcome of the FDA’s review of
any resubmitted NDA relating to the ZIMHI product; the company’s
beliefs concerning its ability to commercialize ZIMHI and its other
products and product candidates; 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 commercialization agreement or commercial launch relating to
its ZIMHI product; 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; anticipated dates for making
regulatory filings with the FDA; 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 that
the results of the additional company testing relating to
ZIMHI will be successful, that the company will be able to
successfully develop the additional information required for
resubmission of the ZIMHI NDA, or concerning the timing of
completion of testing and development of the additional information
for resubmission of the NDA. In addition, there can be no
assurance that the FDA will conclude that any NDA that the
company resubmits will satisfactorily respond to the matters raised
in the FDA’s CRL or discussed in the Type A meeting, concerning the
timing of any resubmission by Adamis of the NDA, that
the FDA will approve our NDA relating to our ZIMHI
product, or concerning the timing of any future action by
the FDA on our 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, 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 may
require additional funding, and there are no assurances that such
funding will be available if required. 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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