Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
financial results for the first quarter ended March 31, 2020 and
provided a business update.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, stated, “We are pleased to have resubmitted
our ZIMHI New Drug Application to the FDA to get us back on track
for regulatory review. We are also very excited to be partnering
with US WorldMeds to commercialize both our SYMJEPI and ZIMHI
products here in the U.S. Certainly, Adamis has been negatively
affected by the COVID-19 outbreak and the various degrees of
lockdowns, and it remains to be seen how quickly everyone can get
back to a new normal. However, we continue to operate and progress
on a number of objectives. We will continue these efforts to
mitigate the financial impact of the pandemic.”
Product Updates
SYMJEPI (epinephrine) Injection
Earlier this month, the company announced that it had entered
into an agreement with Sandoz Inc. providing for the mutually
agreed return to Adamis of the marketing, promotion, and
distribution rights to the company’s
SYMJEPI ® (epinephrine) Injection 0.3mg,
SYMJEPI® (epinephrine) Injection 0.15mg products currently
marketed and available in the United States, and the termination of
the commercialization agreement between Adamis and Sandoz,
following a transition period, supported by a transition services
agreement that is currently being negotiated. Adamis also
simultaneously entered into an exclusive distribution and
commercialization agreement with US WorldMeds, LLC (USWM)
for the United States commercial rights for the SYMJEPI
products as well as the Company’s ZIMHI™ (naloxone HCI
Injection, USP) 5mg/0.5mL product candidate.
In addition to the U.S., Adamis continues to seek opportunities
to market SYMJEPI into other territories and in October 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
Adamis has entered into an exclusive distribution and
commercialization agreement with USWM for the U.S. commercial
rights for ZIMHI™ (naloxone HCI Injection, USP) 5mg/0.5mL product
candidate. Under the terms of the Adamis/USWM agreement, US
WorldMeds obtained U.S. rights to commercialize and distribute the
SYMJEPI products, upon the termination of Sandoz’s commercial
rights, and ZIMHI, if approved by the U.S. Food and Drug
Administration, in exchange for an upfront payment and potential
regulatory and commercial milestones totaling up to $26 million.
Additionally, after deducting the supply price and certain other
deductions, including an allocation for USWM sales and distribution
expenses from net sales of the products, Adamis and USWM will share
equally in the net profits, as defined in the agreement.
Earlier today, the company announced the resubmission of the
company’s New Drug Application (“NDA”) to the U.S. Food and Drug
Administration (“FDA”) for its ZIMHI product candidate. The
resubmission follows the company’s meeting with the agency in
February and is intended to address the issues raised by the FDA in
the agency’s November 2019 Complete Response Letter (“CRL”).
Drug Outsourcing Facility
During the first quarter of 2020, sterile and non-sterile
revenues from the company’s wholly owned drug outsourcing facility,
US Compounding (USC), decreased by approximately 6% in the first
quarter compared to the same quarter in the prior year. Revenues
from the sale of pharmaceutical formulations by USC were adversely
affected by slowing demand due to the novel coronavirus outbreak.
The company is seeking to mitigate the impact with the development
and launch of products for which there has been a recent increase
in demand.
First Quarter Financial Results
Revenues were approximately $4.7 million and $4.9 million for
the three months ended March 31, 2020 and 2019, respectively. The
decrease of approximately 5.0% in the first quarter of 2020
compared to the comparable period of 2019 was impacted by the
effect of the pandemic on demand for USC’s products. Specifically,
hospitals cancelled elective and non-emergency procedures, pain
clinics were either shutdown or experienced a significant drop in
office visits during the first quarter and the horse racing
industry shut down.
Selling, general and administrative expenses (“SG&A”)
for the three months ended March 31, 2020 and 2019 were
approximately $6.1 million and $8.0 million, respectively. The
decrease was primarily attributable to decreases in wages, benefits
and other compensation expenses, and to a lesser extent by
decreases in operational expenses relating to the ceasing of
sales of certain USC products, and decreases in patent, consulting,
outside services, professional fees, PDUFA fees, depreciation and
other related expenses.
Research and development expenses were approximately $2.0
million and $2.2 million for the three months ended March 31,
2020 and 2019, respectively, a decrease of approximately 7.3%. The
decrease was primarily due to a decrease in development costs
of our product candidates.
Cash and equivalents at the end of the first quarter was
approximately $10.5 million. In February 2020, the company
completed a registered direct offering of common stock, and a
concurrent private placement of warrants, resulting in estimated
net proceeds of approximately $6.2 million.
Targeted Milestones
- Transition SYMJEPI commercial responsibility from Sandoz to
USWM;
- FDA approval and U.S. commercial launch of ZIMHI;
- Develop and launch new USC products to help offset the impact
of pandemic; and
- Complete a Phase III ulcer study in horses.
Conference CallAdamis will host a conference
call and live webcast on Monday, May 18,
2020 at 2:00 pm Pacific Time to discuss its
financial and operating results for the first quarter of 2020 as
well as provide an update on business developments and
activities.
US Dial-in (Toll Free): 1-877-423-9813
TOLL/International Dial-in: 1-201-689-8573
Conference ID: 13703885
Webcast: http://public.viavid.com/index.php?id=139872
In addition, a telephone playback of the call will be available
after approximately 5:00 pm PT on May 18, 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 13703885.
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. 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 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; 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 CRL or
discussed in the Type A meeting, 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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