Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
financial results for the year ended December 31, 2018 and provided
a business update.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, stated, “There were several significant
developments for our company during 2018. I view the
marketing and distribution agreement with Sandoz for our
SYMJEPI™ products, approval of the SYMJEPI 0.15mg product and
submission of a new drug application (NDA) for our higher dose
naloxone injection product to be the most significant developments,
laying the groundwork for what I hope will be a transformative year
for the company. We are also encouraged by the performance of
US Compounding in early 2019 and we look forward to expanding our
production capacity.”
Select Events Since Last Business Update:
- First commercial product delivered to Sandoz;
- NDA submitted to the FDA and accepted for review for the higher
dose naloxone injection product candidate;
- NDA submitted to the FDA and received a refusal to file letter
for the tadalafil product candidate;
- Drug Outsourcing Facility (U.S. Compounding) increased revenue
by 15%; and
- Sandoz announces launch of SYMJEPI 0.3mg product to the
institutional market in the U.S.
Product Updates
SYMJEPI (epinephrine) Injection (0.3mg and 0.15mg)
As announced in the third quarter of 2018, the company entered
into a commercialization and distribution agreement with Sandoz, a
division of Novartis, to market and sell SYMJEPI (epinephrine)
Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg (upon
approval) in the U.S. The company also granted Sandoz a right
of first negotiation for territories outside the U.S. On
September 27, 2018, the FDA approved the SYMJEPI 0.15mg
product. In January 2019, Sandoz announced the launch of
SYMJEPI 0.3mg product for the institutional market in the U.S.
APC-6000 (naloxone)
As announced in December 2018, the company filed an NDA relating
to its higher dose naloxone injection product for the treatment of
opioid overdose. On March 14, 2019, the company received
notice from the FDA that it had determined the NDA was sufficiently
complete to permit a substantive review and provided a target
agency action date of October 31, 2019. Please refer to the
company’s March 14, 2019 press release for additional
information.
APC-8000 (sublingual tadalafil)
In December 2018, the company announced that it had filed an NDA
for a fast-disintegrating sublingual tadalafil (APC-8000) product
candidate. On February 26, 2019, the company received a
refusal to file letter from the FDA indicating it had determined
that the submitted NDA was not sufficiently complete to permit a
substantive review. The FDA requested that the company
supplement and include in a resubmitted NDA additional data and
information. The company continues to evaluate the FDA’s
comments, and it may seek immediate guidance from the FDA,
including requesting a Type A meeting, to discuss the letter and
the specific deliverables the agency would require for a
resubmitted NDA to be deemed complete.
APC-1000 (beclomethasone)
In 2018, the company submitted an IND application and
received clearance from the FDA to begin Phase 3 efficacy studies
for APC-1000. In Q4 2018, it initiated the start-up phase of
the phase 3 studies of APC-1000. The company anticipates that
trial enrollment will commence in 2019; however, the timing of
enrollment and completion of such studies could be affected by a
number of factors as described in the company’s Form
10-K.
APC-4000 (fluticasone)
During 2018, the company completed development and manufacturing
work on the patented dry powder inhaler (DPI) technology that the
company acquired from 3M. Adamis is now focused on continuing
and completing the drug development work, which includes loading
fluticasone onto the tape and into the device, in order to
demonstrate the device can achieve the targeted dosing. Once
completed, the company may seek a development or commercial partner
to help advance the product through a regulatory pathway.
Drug Outsourcing Facility
The company’s wholly-owned subsidiary, US Compounding (USC), has
continually grown its revenues year over year since Adamis acquired
the division. During 2018, USC continued to make improvements
in its processes and efficiencies while maintaining its focus on
quality. Although net revenue grew 15% over 2017, it did not
meet the company’s previously stated growth target.
Therefore, during the first quarter of 2019, Adamis has made
changes to USC personnel and strategy with the objective of
achieving profitability for the division during 2019.
2018 Financial Results
Revenues were approximately $15.1 million and $13.1 million for
the years ended December 31, 2018 and 2017, respectively. The
increase of approximately $2.0 million reflected an increase in
sales of USC’s compounded and non-compounded pharmaceutical
formulations resulting in part from price increases, increase in
unit sales production capacity in order to meet product demand, and
marketing personnel efforts.
Selling, general and administrative expenses (SG&A) for
the years ending December 31, 2018 and 2017 were
approximately $26.0 million and $22.8 million, respectively.
SG&A expenses consist primarily of depreciation and
amortization, legal fees, accounting and audit fees,
professional/consulting fees and employee compensation.
Compensation expense for SG&A employees increased by
approximately $2.0 million for 2018 compared to 2017, primarily due
to new hires, increases in salary expenses and bonus accruals, and
expenses associated with equity compensation and other employee
benefits. Approximately $0.5 million of the increase for 2018
was due to PDUFA fees, marketing, selling, insurance, consulting,
outside services and travel expenses; approximately $0.3 million of
the increase was due to increases in patent fees; and approximately
$0.4 million of the increase was due to increases in occupancy
costs, insurance, supplies, taxes, and other related expenses.
Research and development expenses (R&D) were approximately
$18.8 million and $7.5 million for the years ended December 31,
2018 and 2017, respectively. The increase in R&D for
2018, compared to 2017 was primarily due to an increase
of approximately $8.8 million in development costs of the
company’s product candidates, including APC-1000, APC-4000,
APC-6000 and APC-8000. Compensation for R&D employees,
consulting, and other operating expenses increased by approximately
$1.6 million for 2018 compared to 2017, primarily due to new hires
and cash and equity compensation expenses. As noted in its
November 2018 press release, the company experienced increased
research and development expenses for the fourth quarter of
2018.
At December 31, 2018, the Company had cash and cash equivalents
of $19.3 million.
Targeted Future Milestones
- FDA approval for the higher dose naloxone product candidate -
target agency action date of October 31, 2019;
- Sandoz’s launch of the SYMJEPI 0.3mg and 0.15mg products for
the U.S. retail market;
- Commercial agreements for the naloxone product candidate and
for the SYMJEPI 0.3mg and 0.15mg products outside of the U.S.;
and
- US Compounding reaching profitability in 2019 (targeted by
mid-year).
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 and allergy. 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. Adamis previously announced a
distribution and commercialization agreement with Sandoz, a
division of Novartis Group, to market Symjepi in the U.S.
Adamis is developing additional products, including a
naloxone injection product candidate for the treatment of opioid
overdose, a sublingual tadalafil product candidate for the
treatment of erectile dysfunction, 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. These statements relate to future events or future
results of operations, including, but not limited to the following
statements: the company’s beliefs concerning the timing and outcome
of Sandoz’s launch and commercialization activities relating to the
SYMJEPI™ (epinephrine) Injection 0.3mg and 0.15mg products;
statements about strategies, objectives and our future goals and
achievements; the company’s ability to commercialize its product
and product candidates; the company’s beliefs concerning the
ability of its products and product candidates to compete
successfully in the market; 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; the
company’s beliefs concerning the safety and effectiveness of its
products and product candidates; expectations and goals for future
growth; current or planned clinical trials or research and
development activities; 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. 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. 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 to continue operations, and there are no
assurances that such funding will be available. Failure to
timely obtain required funding would adversely affect 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. These statements are only
predictions, are not guarantees, involve known and unknown risks,
uncertainties and other factors, and concern matters that could
subsequently differ materially from those described in this press
release, which may cause Adamis' actual results to be materially
different from those contemplated by these 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, 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, 2018,
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.
Contacts: Mark Flather Senior Director,
Investor Relations& Corporate Communications Adamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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