SAN DIEGO, March 23, 2016 /PRNewswire/ -- Imprimis
Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company
focused on the development and commercialization of proprietary and
customizable drug formulations, today reported financial results
for the fourth quarter and year ended December 31, 2015, and will provide an update on
recent business developments on a conference call this
afternoon.
Key Fourth Quarter Financial Highlights and Recent
Developments
Financial Highlights
- Total revenues reported for the fourth quarter 2015 increased
by over 500% between years to $3.5
million, from $0.55 million
reported in the fourth quarter of 2014. Full year 2015 revenue
totaled $9.72 million, an increase of
485% compared to $1.66 million
reported for full year 2014.
- Adjusted EBITDA for the fourth quarter of 2015 was $(2.97) million, or approximately $(0.31) per share of common stock.
- In January 2016, the company
amended its note purchase agreement with an affiliate of Life
Sciences Alternative Funding, LLC and issued a $3 million convertible note in exchange for
$3 million in gross proceeds.
- In March 2016, we completed a
public offering of common stock for a total of $12 million in gross proceeds, before deducting
underwriting and other offering expenses.
Commercialization and Corporate Developments
- Launched the Imprimis Cares program and introduced our
customizable pyrimethamine and leucovorin formulation providing a
significantly lower-cost therapeutic alternative to
Daraprim®. Our customizable Daraprim alternative is now
offered through Express Scripts, the largest pharmacy benefit
manager in the U.S., and by many other hospitals and healthcare
organizations. Since December 15,
2015, we have dispensed more than 7,300 doses, representing
a savings to patients and healthcare providers of almost
$5.5 million when compared to
purchasing Daraprim.
- Announced plans to introduce a new patent-pending tiopronin and
potassium citrate delayed release compounded formulation as a
lower-cost therapeutic alternative to the FDA-approved
Thiola® for cystinuria patients. Tiopronin is the sole
active pharmaceutical ingredient in Thiola and is on the FDA's drug
shortage list. Our plan is to continue to expand our Imprimis
Cares formulary and introduce additional drug formulations for
patient populations that may not have available alternatives to
increasingly expensive FDA-approved medications. In this regard, we
expect to continue to work with pharmacy benefit managers (PBMs),
insurance companies, hospitals, and physicians to provide their
beneficiaries access to affordable compounded medications.
- Successfully secured discrete billing codes specific to our
Imprimis Cares formulations in order to facilitate seamless
transactions with payors.
- Co-sponsored the "Analysis of the Economic Impacts of Dropless
Cataract Therapy on Medicare, Medicaid, State Governments, and
Patient Costs" economic study by Andrew
Chang & Co, LLC that demonstrated our Dropless Therapy
could provide savings to Medicare, Medicaid and patients of up to
$13 billion, assuming a cost of
$100 per Dropless Therapy dose.
- Acquired the rights to new proprietary conscious sedation
formulations for patients undergoing ophthalmic surgery and other
surgical procedures. We plan to formally introduce this new
formulation at the American Society of Cataract and Refractive
Surgery Symposium in May 2016.
- Acquired the assets and businesses of the once leading U.S.
providers of compounded sinus medications and re-launched the
business.
- We now own the rights to a library of 44 domestic and
international patents or pending patent applications for drug
formulations or related technologies. Additionally, we have
84 domestic and international issued or pending trademarks
connected to and supportive of our commercial sales and marketing
activities. We expect to continue to aggressively protect our
ideas by filing additional patent applications and prosecuting
those who violate our intellectual property rights.
ImprimisRx Pharmacy Operations
- Continued construction of the company's new 8,600 square foot
facility in Roxbury, NJ, which is expected to be completed and
registered with the U.S. Food and Drug Administration (FDA) as an
outsourcing facility near the end of the second quarter 2016.
- Nearing the completion of construction at our Texas pharmacy with plans to register with the
FDA and begin operations as an outsourcing facility during the
second quarter 2016.
Mark L. Baum, Chief Executive
Officer of Imprimis, stated, "We are pleased with the record growth
in the fourth quarter and for the full year of 2015.
Following the recent completion of our $12
million capital raise in March, we believe we are well
positioned to execute our business strategy as we work with payors,
both public and private, to expand our Imprimis Cares
program. During 2016, we look forward to furthering our
current market share within key therapeutic areas and also
introducing new formulations that we believe provide patients with
high quality and lower cost drug choices. With the expected
opening of our FDA-registered outsourcing facilities in
Texas and New Jersey, and the expansion of our
Imprimis Cares formulary, we believe 2016 will be another
year of setting new records and financial milestones, as we
continue our march towards profitability."
Financial Summary:
Selected highlights regarding operating results for the three
months and full year ended December 31,
2015 and for the same periods in 2014 are as follows (in
thousands, except per share data):
|
For the three
months
ended December 31, 2015
|
For the three
months
ended December 31, 2014
|
Total
Revenues
|
$3,503
|
$ 550
|
Cost of
Sales
|
1,947
|
378
|
Selling &
Marketing Expenses
|
2,041
|
928
|
General &
Administrative Expenses
|
4,177
|
1,924
|
Research &
Development Expenses
|
33
|
71
|
Other Income
(Expense), net
|
(429)
|
6
|
Net
Loss
|
$(5,124)
|
$ (2,745)
|
Net Loss per
Common Share
|
$(0.53)
|
$ (0.30)
|
|
|
For the year
ended
December 31, 2015
|
For the year
ended
December 31, 2014
|
Total
Revenues
|
$9,716
|
$ 1,660
|
Cost of
Sales
|
5,206
|
1,093
|
Selling &
Marketing Expenses
|
6,496
|
2,390
|
General &
Administrative Expenses
|
12,504
|
8,087
|
Research &
Development Expenses
|
332
|
237
|
Other Income
(Expense), net
|
(1,077)
|
29
|
Net
Loss
|
$(15,899)
|
$(10,118)
|
Net Loss per
Common Share
|
$(1.66)
|
$ (1.11)
|
|
Adjusted EBITDA
In addition to the company's results of operations determined in
accordance with U.S. generally accepted accounting principles
(GAAP), which are presented and discussed above, management also
utilizes adjusted EBITDA, an unaudited financial measure that is
not calculated in accordance with GAAP, to evaluate the company's
financial results and performance and to plan and forecast future
periods. Adjusted EBITDA is considered a "non-GAAP" financial
measure within the meaning of Regulation G promulgated by the SEC.
Management believes that this non-GAAP financial measure
reflects an additional way of viewing aspects of the company's
operations that, when viewed with GAAP results, provides a more
complete understanding of the company's results of operations and
the factors and trends affecting its business. Management
believes adjusted EBITDA provides meaningful supplemental
information regarding the company's performance because (i) it
allows for greater transparency with respect to key metrics used by
management in its financial and operational decision-making;
(ii) it excludes the impact of non-cash or, when specified,
non-recurring items that are not directly attributable to the
company's core operating performance and that may obscure trends in
the company's core operating performance; and (iii) it is used
by institutional investors and the analyst community to help
analyze the company's results. However, adjusted EBITDA and
any other non-GAAP financial measures should be considered as a
supplement to, and not as a substitute for, or superior to, the
corresponding measures calculated in accordance with GAAP. Further,
non-GAAP financial measures used by the company and the manner in
which they are calculated may differ from the non-GAAP financial
measures or the calculations of the same non-GAAP financial
measures used by other companies, including the company's
competitors.
The company defines adjusted EBITDA as net income (loss)
excluding the effects of interest, taxes, depreciation,
amortization, stock-based compensation, other income (expense) and,
if any and when specified, other non-recurring income or expense
items. The company believes that the most directly comparable
GAAP financial measure to adjusted EBITDA is net loss. Adjusted
EBITDA has limitations and should not be considered as an
alternative to gross profit or net loss as a measure of operating
performance or to net cash provided by (used in) operating,
investing or financing activities as a measure of ability to meet
cash needs.
The following is a reconciliation of adjusted EBITDA, a non-GAAP
measure to the most comparable GAAP measure, net loss, for the
three months ended December 31, 2015
(in thousands):
|
For the three
months
ended December 31, 2015
|
Net
Loss
|
$ (5,124 )
|
Stock-based
compensation
|
1,124
|
Non-recurring
expenses(1)
|
442
|
Interest
(income) expense, net
|
429
|
Taxes
|
-
|
Depreciation
|
69
|
Amortization
of intangible assets
|
91
|
Adjusted
EBITDA
|
$ (2,969)
|
|
(1)
|
Non-recurring expense
items included certain transactional expenses and expenses related
to restructuring the company's sales and marketing efforts,
including severance expenses.
|
|
|
Conference Call and Webcast
The company will hold a conference call and audio-only webcast
today at 4:30 p.m. EDT (1:30 p.m. PDT). The conference call and
webcast will be open to all listeners and a question and answer
session will follow the prepared remarks. To participate,
dial 877-407-8035 domestically, or 201-689-8035 internationally,
approximately 5 to 10 minutes prior to the start of the call.
Additionally, you can listen to the event online at
http://www.investorcalendar.com/IC/CEPage.asp?ID=174685, as well as
at the company's website at www.imprimispharma.com. If you
are unable to participate during the live webcast, the event
archive will be available at
http://www.investorcalendar.com/IC/CEPage.asp?ID=174685 or at the
company's website at www.imprimispharma.com. You may access
the teleconference replay by dialing 877-660-6853 domestically or
201-612-7415 internationally, referencing conference
13629827. The replay will be available until April 23, 2016.
ABOUT IMPRIMIS PHARMACEUTICALS
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a national
leader in the development, production and dispensing of novel
compounded pharmaceuticals. The company's two business programs,
Imprimis Cares™ and Custom Compounding Choice™, focus
on patient outcomes and affordability by offering high quality
custom compounded drugs in all 50 states. Headquartered in
San Diego, California, Imprimis
owns and operates four dispensing facilities located in
California, Texas, New
Jersey and Pennsylvania.
For more information about Imprimis, please visit the corporate
website at www.ImprimisPharma.com.
SAFE HARBOR
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such "forward looking statements." Forward
looking statements are based on management's current expectations
and are subject to risks and uncertainties which may cause results
to differ materially and adversely from the statements contained
herein. Some of the potential risks and uncertainties that could
cause actual results to differ from those predicted include risks
and uncertainties related to Imprimis' ability to make commercially
available its compounded formulations and technologies in a timely
manner or at all; physician interest in prescribing its
formulations; risks related to its compounding pharmacy operations;
its ability to enter into other strategic alliances, including
arrangements with pharmacies, physicians and healthcare
organizations for the development and distribution of its
formulations; its ability to obtain intellectual property
protection for its assets; its ability to accurately estimate its
expenses and cash burn, and raise additional funds when necessary;
risks related to research and development activities; the projected
size of the potential market for its technologies and formulations;
unexpected new data, safety and technical issues; regulatory and
market developments impacting compounding pharmacies, outsourcing
facilities and the pharmaceutical industry; competition; and market
conditions. These and additional risks and uncertainties are more
fully described in Imprimis' filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-K and
its Quarterly Reports on Form 10-Q. Such documents may be read free
of charge on the SEC's web site at www.sec.gov. Undue reliance
should not be placed on forward-looking statements, which speak
only as of the date they are made. Except as required by law,
Imprimis undertakes no obligation to update any forward looking
statements to reflect new information, events or circumstances
after the date they are made, or to reflect the occurrence of
unanticipated events.
All Imprimis compounded formulations may only be prescribed
pursuant to a physician prescription for an individually identified
patient consistent with federal and state laws governing compounded
drug formulations.
Investor Contact
Bonnie
Ortega
bortega@imprimispharma.com
858.704.4587
Media Contact
Paul
Rabin
paul@pascalecommunications.com
516.503.0271
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SOURCE Imprimis Pharmaceuticals, Inc.