Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a
biopharmaceutical company developing and commercializing specialty
products for respiratory disease, allergy and opioid overdose,
today announced financial results for the year ended December 31,
2020 and provided a business update.
“Adamis made significant advancements over the past year and
that momentum has carried over into 2021,” stated Dennis J. Carlo,
Ph.D., President and Chief Executive Officer of Adamis
Pharmaceuticals. “We completed the transition of SYMJEPI to our new
commercial partner, US WorldMeds, and we look forward to its
continued market penetration and sales growth in 2021. As we
announced earlier this week, we recently met with the FDA to
discuss the regulatory path forward for ZIMHI in the treatment of
opioid overdose, and we intend to resubmit our NDA to the FDA. We
also intend to commence our Phase 2/3 clinical trial for Tempol in
the second quarter of this year, to evaluate the use of Tempol for
the prevention of hospitalization of patients with COVID-19.
Earlier this year, we completed an underwritten public offering
that raised net proceeds of approximately $48.6 million, which
provides the financial flexibility we need to move our programs
forward. Adamis has an opportunity to reach several meaningful
inflection points that could make 2021 a transformative year for
the company.”
Product and Pipeline Updates and Other Corporate
Developments
SYMJEPI (epinephrine) Injection
- In October 2020, the SYMJEPI product line, for use in the
emergency treatment of acute allergic reactions, completed its
transition to a new commercial partner, US WorldMeds.
- In January 2021, the SYMJEPI products became available through
the Walgreens Prescription Savings Club. The products are being
offered at a discounted price of $99.99 per two-pack, which the
company believes is the lowest price for an epinephrine device in
the U.S.
ZIMHI (naloxone) Injection
- Adamis submitted responses to the FDA to address the
deficiencies identified in a complete response letter (CRL)
received in November. Adamis recently met with the FDA to discuss
the responses. After the meeting, and based on discussions with the
agency, Adamis expects to resubmit the Naloxone NDA within the next
45 days.
- Recently, the U.S. Patent and Trademark Office allowed one
of Adamis’ patent applications relating to ZIMHI. The claims
allowed describe a naloxone composition at a dose greater than or
equal to five milligrams configured for administration as an
injection.
Tempol
- In June 2020, Adamis entered into an exclusive worldwide
license for a novel patented compound, Tempol, for the treatment of
all respiratory diseases including asthma, respiratory syncytial
virus, influenza and COVID-19. Additionally, the license also
includes the use of Tempol for reducing radiation dermatitis in
patients undergoing treatment for cancer.
- In February 2021, the company announced results from a study in
collaboration with Stanford University demonstrated that Tempol
inhibited the release of multiple cytokines from activated immune
cells of COVID-19 patients, which may be a unique mechanism of
action for the agent. In-vivo preclinical data from a hamster virus
challenge model has shown an attenuation of the lung pathology and
more rapid healing in animals treated with Tempol. This animal
model has been used successfully to test vaccines and monoclonal
antibodies against COVID-19. These results further support the
clinical program of testing Tempol in early COVID.
- The company’s IND relating to a protocol for a clinical trial
of Tempol in COVID-19 patients received FDA clearance in January
2021. Adamis expects to begin the Phase 2/3 trial during the second
quarter of 2021 to examine the effects of Tempol on preventing
hospitalization in subjects with COVID-19 infection.
Drug Outsourcing Facility
- In January, the company announced that it had entered into a
non-binding letter of intent with a potential buyer for the sale of
substantially all of the assets of its US Compounding, Inc. (USC)
registered outsourcing facility subsidiary. Under the terms of the
LOI, the buyer would acquire substantially all of the assets of
USC, in exchange for a total gross consideration that could range
from approximately $10-$20 million, before transaction fees
and expenses and other potential post-closing adjustments. Any
definitive agreement would be subject to approval by the respective
parties, including approval by the board of directors of Adamis,
and would likely include customary provisions, including
representations and warranties of Adamis and USC, restrictive
covenants and indemnification provisions.
2020 Financial Results
Total revenues for the year ended December 31, 2020 and 2019
were $16.5 million and $22.1 million, respectively. The total
revenue decrease was primarily attributable to a decline in sales
of products by USC due to restrictions and limitations on
outpatient surgery and other medical procedures caused by the
COVID-19 pandemic, and related impacts of the pandemic on sales and
marketing efforts.
Selling, general and administrative expenses for the years
ending December 31, 2020 and 2019 were approximately $30.6 million
and $25.3 million, respectively. The increase was primarily due to
the $7.9 million contingent liability related to the Nephron
litigation, offset by the decreases in selling expenses at USC.
Research and development expenses were approximately $8.3
million and $10.4 million for the years ended December 31, 2020 and
2019, respectively. The decrease was primarily due to a
decrease in development expense for the company’s pipeline
candidates.
Cash and equivalents at the end of the year was approximately
$6.9 million. In January and February 2021, the company received
approximately $5.9 million and $48.6 million from the exercise of
warrants and an equity financing transaction, respectively.
Targeted Potential Milestones
- Resubmit the ZIMHI NDA to FDA within the next 45 days
- Start of Phase 2/3 clinical trial of Tempol in COVID-19
patients in the second quarter of 2021
- Progress from non-binding term sheet to executed purchase
agreement for the sale of USC outsourcing division in the second
half of 2021
- On-going market penetration and increasing sales of SYMJEPI in
the U.S. throughout 2021
- Approval and commercial launch of ZIMHI
Conference Call
Adamis will host a conference call and live webcast today, April
15, 2021 at 2 p.m. PDT (5 p.m. EDT) to discuss its financial and
operating results for the fourth quarter 2020 and year ended
December 31, 2020, 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:
13718949Webcast: http://public.viavid.com/index.php?id=144486If
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. Adamis’ naloxone injection
product candidate, ZIMHI, for the treatment of opioid overdose, is
currently under FDA review. Adamis is developing additional
products, including treatments for acute respiratory diseases, such
as COVID-19, influenza, asthma, and COPD. The company’s subsidiary,
US 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. For additional information about Adamis
Pharmaceuticals, please visit
www.adamispharmaceuticals.com.
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
beliefs or that 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 its ability to satisfactorily
respond to the matters raised in the FDA’s Complete Response Letter
(CRL) relating to the company’s New Drug Application (NDA) for the
ZIMHI product, the results of the company’s Type A meeting with
the FDA regarding the ZIMHI NDA, and the company’s ability to
prepare and resubmit the ZIMHI NDA to the FDA within the time
period anticipated by the company, and whether the FDA will accept
a resubmitted NDA for review; the company’s beliefs concerning the
results of any future studies or clinical trials that the company
may conduct relating to Tempol, ZIMHI or its other products or
product candidates; the company’s beliefs concerning the
anticipated timing of commencement of clinical studies relating to
Tempol; the company’s beliefs concerning anticipated commencement
and completion dates for clinical trials; the company’s beliefs
concerning its ability to commercialize its 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;
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; expectations and goals for future
growth; guidance regarding future periods; the outcome of the
transactions contemplated by the non-binding letter of intent
relating to USC; and other statements concerning our future
operations and 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,
and 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 results
of the company’s Type A meeting with the FDA regarding the
company’s NDA relating to ZIMHI, the timing of any resubmission of
the NDA, or that the company will be able to successfully take any
actions or develop any additional information that the FDA may
require in connection with its review of any resubmitted NDA for
ZIMHI. The FDA may require additional studies, or other actions,
data or information, relating to the ZIMHI NDA. There can be no
assurances that the FDA will regarding the company’s responses to
the matters raised in the ZIMHI CRL as satisfactory, concerning the
timing or costs of any additional actions that may be required in
connection with any resubmission of the NDA, concerning the timing
of any resubmission of the ZIMHI NDA, that the FDA will approve any
resubmitted NDA relating to our ZIMHI product, that the company
will be successful in any formal dispute resolution appeal process
with the FDA, or that the product will be able to compete
successfully in the market if approved and launched. 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 have 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, 2020, 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.
Contact:
Investor Relations atAdamis Pharmaceuticals Corporation (858)
997-2400 option 3IR@adamispharma.com
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