Adamis Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update
August 10 2022 - 4:02PM
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
second quarter of 2022 and provided an update on recent corporate
developments.
“I committed to the CEO role in May because I could see beyond
Adamis’ current position to where it could go. I knew the Company
had strong assets which we could leverage to unlock shareholder
value,” said David J. Marguglio, CEO of Adamis. “We have two
FDA-approved products competing in large markets. We have an
ongoing Phase 2/3 trial for Tempol that, if it shows significant
efficacy, could not only potentially become a blockbuster treatment
for COVID-19, but could be potentially expanded to treat other
respiratory diseases. Most importantly, we have a small, yet
devoted team of highly qualified and experienced individuals
committed to both saving patient lives and growing Adamis.”
Product and Pipeline Updates and Other Corporate
Developments
ZIMHI ™ (naloxone) Injection
- US WorldMeds (USWM) began shipping
ZIMHI to wholesalers at the end of March. The commercial launch is
proceeding as planned.
- USWM-relayed feedback from the
field has been decidedly positive. Many customers feel ZIMHI’s
combination of a higher dose with intramuscular delivery provides
an advantage and significantly differentiates it from the leading
competitors.
- A recently launched website enables
institutional customers to order and receive product directly
through ZimhiDirect.com.
- Progress continues in adding ZIMHI
to formularies for payors and PBMs. It has been added to the
standing orders in 25 states - which permits pharmacies to dispense
ZIMHI without a prescription.
- While market access is increasing,
USWM has fielded a team of sales reps detailing doctors and clinics
to increase awareness and ultimately drive scripts.
SYMJEPI ® (epinephrine) Injection
- In March, the Company announced
that manufacturing issues had led to a voluntary recall of four
lots of SYMJEPI due to the potential for clogged needles.
- An investigation lasting several
months determined a single batch of stainless-steel needles was the
root cause of the failures. Adamis and the manufacturer have
developed corrective and preventive actions, and new syringes have
been sourced.
- Adamis is committed to returning
SYMJEPI to the market as soon as all stakeholders are satisfied
that these corrective actions should prevent a similar failure in
future batches.
TEMPOL
- Adamis believes that patient
enrollment in the Phase 2/3 clinical trial is nearly
completed.
- The Data Safety Monitoring Board is
scheduled to meet near the end of September to review unblinded
interim data including safety and efficacy. Adamis will remain
blinded to the data until the final study data is compiled and
reviewed.
- If interim trial data shows
significant efficacy, the DSMB may recommend stopping the trial in
light of the significant efficacy, and Adamis would likely seek to
meet with FDA to discuss next steps and requirements for applying
for Emergency Use Authorization, which could be a significant
positive development for the Company, patients and healthcare
providers.
- The Company is exploring other
potential indications for Tempol and seeking both government and
non-government funding to further development.
Financial Results
- Revenues for the six months ending
June 30, 2022 and 2021 were approximately $1.2 million and $2.6
million, respectively. The decrease in revenues was primarily due
the manufacturing hold and recall of SYMJEPI in 2022, offset by the
product launch of ZIMHI.
- Selling, general and administrative
expenses for the first six months ending June 30, 2022 and 2021
were approximately $7.6 million and $8.5 million, respectively. The
decrease was primarily due to the decreases in compensation and
legal expenses.
- Research and development expenses
were higher for the first six months of 2022, at approximately $7.5
million, compared to $4.4 million in the same period in 2021. The
increase was primarily related to the ongoing clinical trial for
Tempol.
- Net loss from discontinued
operations for the six months ended June 30, 2022 and 2021 was
approximately $0.2 million and $3.1 million, respectively. This
decreased loss was primarily attributable to the cessation of US
Compounding’s operations.
- Cash and cash equivalents at the
end of the second quarter totaled $8.9 million. Cash expenses were
higher than expected due to approximately $5.2 million in
disbursements relating to the repayment of the Second Draw Paycheck
Protection Program loan, expenses related to the SYMJEPI recall and
employment separation expenses. Although there are no assurances,
the Company expects to receive additional proceeds during the
second half of 2022, which could range from collections of
approximately $2.0 to 3.5 million pursuant to the sale of certain
USC assets to Fagron in 2021, and from the disposition of the
remaining USC assets.
Conference Call Information
Management will host a live webcast/conference call today,
August 10, 2022 at 4:30 p.m. ET / 1:30 p.m. PT, during which
Company executives will review financial information for the second
quarter of 2022 and provide a corporate update.
U.S. Dial-in (Toll Free): (877) 423-9813Toll/International
Dial-in: (201) 689-8573Conference ID: 13731678
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
http://ir.adamispharmaceuticals.com/presentations.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a commercial-stage
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 is in development for the treatment of patients with
COVID-19 and a Phase 2/3 clinical trial is underway. For additional
information about Adamis Pharmaceuticals, please visit our website
and follow us on Twitter and LinkedIn.
Forward Looking StatementsThis 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 Company’s Phase 2/3 clinical trial for
Tempol; statements concerning the activities and process of the
DSMB, the timing and outcome of that process, and any subsequent
meetings or interactions between the Company and the FDA following
the DSMB review; the Company’s beliefs concerning the mechanisms of
action, safety and effectiveness of Tempol and the potential
commercial success of Tempol, if approved; the timing, progress or
results of the Company’s Phase 2/3 clinical trial for Tempol or
other studies or trials relating to Tempol; the Company’s beliefs
concerning the timing and outcome of the investigation, and
corrective and preventing actions, relating to the SYMJEPI
manufacturing hold and product recall, and concerning 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 beliefs concerning the
safety and effectiveness of SYMJEPI, ZIMHI or its other products
and product candidates; 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 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 target future milestones or achievements
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. 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.
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. 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
ADAMIS PHARMACEUTICALS CORPORATION AND
SUBSIDIARIES |
CONSOLIDATED BALANCE SHEET DATA (Unaudited) |
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
Cash and Cash Equivalents |
|
$ |
8,875,925 |
|
|
$ |
23,220,770 |
|
Total Current Assets |
|
|
15,320,615 |
|
|
|
35,203,622 |
|
Total Assets |
|
|
17,694,435 |
|
|
|
38,297,987 |
|
Total Liabilities |
|
|
10,652,292 |
|
|
|
12,415,209 |
|
Accumulated Deficit |
|
|
(296,837,649 |
) |
|
|
(278,085,813 |
) |
Total Stockholders’ Equity |
|
|
7,042,143 |
|
|
|
25,882,778 |
|
|
ADAMIS PHARMACEUTICALS CORPORATION AND
SUBSIDIARIES |
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue, net |
$ |
39,847 |
|
|
$ |
1,275,474 |
|
|
$ |
1,194,361 |
|
|
$ |
2,608,153 |
|
Cost of Goods Sold |
|
689,178 |
|
|
|
1,796,243 |
|
|
|
2,152,760 |
|
|
|
3,641,480 |
|
Selling, General and Administrative Expenses |
|
4,205,934 |
|
|
|
4,934,491 |
|
|
|
7,588,630 |
|
|
|
8,452,542 |
|
Research and Development |
|
3,320,654 |
|
|
|
2,196,721 |
|
|
|
7,542,179 |
|
|
|
4,446,465 |
|
Loss from Operations |
|
(8,175,919 |
) |
|
|
(7,651,981 |
) |
|
|
(16,089,208 |
) |
|
|
(13,932,334 |
) |
Total Other Income (Expense), net |
|
(159,535 |
) |
|
|
(44,574 |
) |
|
|
(2,436,000 |
) |
|
|
(7,686,907 |
) |
Net Loss Applicable to Common Stock |
$ |
(8,397,221 |
) |
|
$ |
(9,313,730 |
) |
|
$ |
(18,751,836 |
) |
|
$ |
(24,692,964 |
) |
Basic & Diluted Loss Per Share |
$ |
(0.06 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.18 |
) |
Basic & Diluted Weighted Average Shares Outstanding |
|
149,815,683 |
|
|
|
148,886,141 |
|
|
|
149,717,104 |
|
|
|
139,228,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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