Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a
commercial-stage biopharmaceutical company primarily focused on
developing and commercializing products in various therapeutic
areas, including allergy, opioid overdose, respiratory and
inflammatory disease, today reported financial results for the
third quarter of 2022 and provided an update on recent corporate
developments.
Process Update
In October, the Company announced that it had initiated a
process to explore a range of strategic and financing alternatives
and had retained an investment bank to assist in evaluating certain
alternatives focused on maximizing stockholder value. Potential
alternatives include a sale, partnership, distribution or other
agreement regarding one or both of the Company’s commercial
products, a sale, merger, or reverse merger of the company, and/or
seeking additional financing. As of today, the Company is engaged
in communications with third parties regarding one or more possible
transactions.
“The strategic process is well under way with the goal of
maximizing shareholder value and preserving cash resources,” stated
David J. Marguglio, CEO of Adamis. “Concurrently, we have
implemented significant expense reduction measures including
employee headcount reductions and pausing all product development
programs. While engaged in this process, we continue to work
closely with our commercial partner to continue the momentum of the
ZIMHI launch and the return of SYMJEPI to the market.”
There can be no assurance regarding the schedule for completion
of the strategic review process, that this strategic review process
will result in the Company pursuing any transaction or that any
transaction, if pursued, will be completed.
Business Updates in Q3 2022
ZIMHI ™ (naloxone) Injection
- Following its introduction to the
market at the end of March, our commercial partner continues to
make steady progress on the ZIMHI commercial launch plan.
- Unit sales increased 90% in the
third quarter compared to the second quarter of 2022.
SYMJEPI ® (epinephrine) Injection
- In March 2022, the Company
announced that manufacturing issues at one of its contract
manufacturers, Catalent Belgium, led to a voluntary recall of four
lots of SYMJEPI. Following corrective and preventative actions,
Catalent resumed operations at its Belgium facility in November
2022.
- Assuming no additional
interruptions or delays, the Company anticipates having SYMJEPI
relaunched and commercially available before the end of the first
quarter of 2023.
TEMPOL
- The Company announced that
following a review of interim data, its Phase 2/3 clinical trial
examining the effects of Tempol in COVID-19 treatment failed to
achieve its primary endpoint and further development of Tempol has
been halted.
Discontinued Operations
- The Company is continuing to
liquidate the assets of the former US Compounding business and,
although there are no assurances, the Company expects to receive
additional proceeds which could range from approximately $3 to $4
million between now and the end of the first quarter of 2023.
Q3 2022 Financial Highlights
- Total net revenue for the third
quarter of 2022 was approximately $1.5 million compared to
approximately $760,000 in the third quarter of 2021, an increase of
98%. The increase in revenues was primarily due to sales of ZIMHI,
the absence of sales for SYMJEPI resulting from the March 2022
product recall and the recognition of deferred revenue under our
commercial distribution agreement, offset by cost of the SYMJEPI
recall.
- Operating expense (selling, general
and administrative expenses and research and development expenses)
for the third quarter of 2022 was approximately $4.5 million
compared to $9.4 million in the third quarter of 2021, a decrease
of 52%. The decrease was primarily due to lower development
spending for Tempol and ZIMHI, decreases in legal and advisory
fees, and a reversal of 2022 accrued bonus expenses.
- Net loss for the combined
(continued and discontinued) operations for the third quarter of
2022 was approximately $4.4 million compared to a net loss of $12.4
million in the third quarter of 2021, a 64% decrease.
- Cash and cash equivalents as of
September 30, 2022 were approximately $2.4 million.
Conference Call Information
Management will host a live webcast/conference call today,
November 14, 2022, at 2:00 p.m. PT / 5:00 p.m. ET, during which
Company executives will review financial information for the third
quarter of 2022 and provide a corporate update.
U.S. Dial-in (Toll Free): 1-888-886-7786
Toll/International Dial-in: 1-416-764-8658
Conference ID: 83680911
A live audio webcast of the conference call will also be
available via this link. 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
https://ir.adamispharmaceuticals.com/events-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 product is approved
for the treatment of opioid overdose. Tempol, which was in
development for the treatment of patients with COVID-19, was the
subject of a Phase 2/3 clinical trial which has been halted. For
additional information about Adamis Pharmaceuticals, please
visit our website and follow us
on Twitter and LinkedIn.
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: statements concerning the outcome of the Company’s
process reviewing strategic and financing alternatives and the
Company’s ability to enter into and complete any strategic
transaction; the Company’s beliefs concerning the SYMJEPI
manufacturing hold and product recall and the timing of resumption
of manufacturing and commercial sales of SYMJEPI; the Company’s
beliefs concerning the progress and success of the commercial
launch of ZIMHI; the Company's beliefs concerning the ability of
its products and product candidates to compete successfully in the
market; the Company’s ability to successfully commercialize the
products and product candidates, itself or through
commercialization partners; future development and regulatory
actions concerning the Company’s products and product candidates;
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; 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 future milestones or achievements
anticipated by forward looking statements in this press release
either within the anticipated time periods or at all. 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, future
liabilities and obligations, and the outcomes of the Company’s
strategic 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. 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. There can be no assurance regarding the
schedule for completion of the Company’s strategic review process,
that this strategic review process will result in the Company
pursuing any transaction or that any transaction, if pursued, will
be completed. In addition, obtaining funding if available, or the
terms of a strategic transaction, could result in significant
dilution to our existing stockholders. If we do not obtain required
funding, our cash resources will be depleted in the near term and
we would be required to materially reduce or suspend operations,
which would likely have a material adverse effect on our business,
stock price and our relationships with third parties with whom we
have business relationships. If we do not have sufficient funds to
continue operations, we could be required to seek bankruptcy
protection, dissolution or liquidation, or other alternatives that
could result in our stockholders losing some or all of their
investment in us. 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, 2021, 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:Adamis Investor RelationsRobert UhlManaging DirectorICR
Westwicke619.228.5886
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ADAMIS PHARMACEUTICALS CORPORATION AND
SUBSIDIARIES |
|
CONSOLIDATED BALANCE SHEET DATA (Unaudited) |
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
Cash and Cash Equivalents |
|
$ |
2,419,960 |
|
|
$ |
23,220,770 |
|
|
Total Current Assets |
|
|
10,088,130 |
|
|
|
35,203,622 |
|
|
Total Assets |
|
|
12,137,286 |
|
|
|
38,297,987 |
|
|
Total Liabilities |
|
|
9,134,556 |
|
|
|
12,415,209 |
|
|
Accumulated Deficit |
|
|
(301,236,550 |
) |
|
|
(278,085,813 |
) |
|
Total Stockholders’
Equity |
|
|
2,845,427 |
|
|
|
25,882,778 |
|
|
|
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ADAMIS PHARMACEUTICALS CORPORATION AND
SUBSIDIARIES |
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(Unaudited) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Revenue, net |
$ |
1,505,683 |
|
|
$ |
759,962 |
|
|
$ |
2,605,396 |
|
|
$ |
3,368,115 |
|
|
Cost of Goods Sold |
|
1,647,585 |
|
|
|
1,565,922 |
|
|
|
3,705,697 |
|
|
|
5,207,402 |
|
|
Selling, General and
Administrative Expenses |
|
2,508,176 |
|
|
|
4,794,485 |
|
|
|
10,096,807 |
|
|
|
13,247,027 |
|
|
Research and Development |
|
1,977,939 |
|
|
|
4,620,143 |
|
|
|
9,520,118 |
|
|
|
9,066,608 |
|
|
Loss from Operations |
|
(4,628,017 |
) |
|
|
(10,220,588 |
) |
|
|
(20,717,226 |
) |
|
|
(24,152,922 |
) |
|
Total Other Income (Expense),
net |
|
356,808 |
|
|
|
5,052,182 |
|
|
|
(2,079,191 |
) |
|
|
(2,634,725 |
) |
|
Net Loss from
Continuing Operations, before taxes |
(4,271,209 |
) |
|
|
(5,168,406 |
) |
|
|
(22,796,417 |
) |
|
|
(26,787,647 |
) |
|
Net Loss from
Discontinued Operations, before taxes |
(127,692 |
) |
|
|
(7,192,642 |
) |
|
|
(354,320 |
) |
|
|
(10,266,365 |
) |
|
Net Loss Applicable to Common
Stock |
$ |
(4,398,901 |
) |
|
$ |
(12,361,048 |
) |
|
$ |
(23,150,737 |
) |
|
$ |
(37,054,012 |
) |
|
Basic & Diluted Loss Per
Share |
$ |
(0.03 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.26 |
) |
|
Basic & Diluted Weighted
Average Shares Outstanding |
|
149,983,265 |
|
|
|
148,886,141 |
|
|
|
149,806,799 |
|
|
|
142,483,194 |
|
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