BAUDETTE, Minn., May 5, 2014 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported
financial results for the three months ended March 31, 2014.
First quarter highlights include:
- First quarter record net revenues of $10.9 million, an increase of 96% as compared to
$5.6 million for the same period in
2013.
- First quarter net income of $3.4
million and EPS of $0.33.
- First quarter adjusted non-GAAP EBITDA of $4.2 million, an increase of over 500% as
compared to $0.7 million in the same
period in 2013.
- Successfully completed a follow-on public offering of common
stock yielding net proceeds of approximately $46.7 million.
- Completed a $12.5 million
acquisition of 31 generic products from Teva Pharmaceuticals.
- Entered into a development agreement for a generic drug with
Sterling Pharmaceutical Services.
- Executed an exclusive license and supply agreement for
Esterified Estrogen raw material.
Net revenues and
Adjusted
Non-GAAP
EBITDA
|
|
(in
thousands)
|
Three months
ended
March
31,
|
|
2014
|
2013
|
Net
revenues
|
$
10,899
|
$
5,562
|
Adjusted Non-GAAP
EBITDA(a)
|
$
4,245
|
$
683
|
|
|
|
(a) See Table 2 for US GAAP reconciliation.
Arthur S. Przybyl, President and
CEO, stated,
"Our first quarter financial results generated record net
revenues of $10.9 million, an
increase of 96%, and non-GAAP EBITDA of $4.2
million, an increase of over 500%, as compared to last year.
More importantly, our net prescription sales increased by
150% due to market share gains and price increases. In
mid-April, we implemented a price increase for our EEMT product,
the full effect of which is anticipated to affect revenues in the
second half of the year, and in January we entered into an
exclusive license and supply agreement for Esterified Estrogen raw
material.
From our 45 pipeline products, we have prioritized 22 that, once
commercialized, are expected to be the main contributors to our
five-year revenue model and business plan. These include internally
developed, partnered, and acquired products on which we will focus
for the next several quarters. We remain committed to launching our
first product that was acquired from Teva in the fourth quarter of
2014.
Finally, during the quarter, our operations generated
$5.2 million in positive cash flow
and we successfully completed a capital raise, funds that enable us
to pursue growth through acquisitions. Today, we have over
$50 million in cash and no debt on
our balance sheet."
First Quarter Results
For the three months ended March 31,
2014, ANI reported net revenues of $10.9 million, an increase of 96% from
$5.6 million in the prior year
period. The increase in revenues was primarily due to a 150%
increase in net prescription sales from $3.5
million to $8.8 million,
primarily due to increased sales of and price increases for ANI's
Esterified Estrogen with Methyltestosterone Tablet ("EEMT")
product. Development services and royalty revenues also increased
by $0.2 million, or 54%. This was
partially offset by a 7% decrease in contract sales, from
$1.7 million to $1.6 million.
Adjusted non-GAAP EBITDA was $4.2
million for the three months ended March 31, 2014, compared to $0.7 million in the prior year period. For a
reconciliation of Adjusted non-GAAP EBITDA to GAAP operating
income, please see Table 2.
Cost of sales decreased as a percentage of net revenues to 24%
from 43%, primarily due to price increases for EEMT.
Research and development costs were $0.4
million and $0.3 for the three
months ended March 31, 2014 and 2013,
respectively. The slight increase was due to the timing of
development projects.
Selling, general and administrative ("SG&A") expenses
increased to $3.7 million for the
three months ended March 31, 2014
from $2.3 million in the prior year
period. The increase was primarily due to increased costs
associated with being a public company. First quarter 2013 SG&A
expense included $0.1 million of
merger-related expenses.
Operating income was $3.5 million
for the three months ended March 31,
2014, as compared to $0.4
million in the prior year period. The first quarter 2013
operating income included $0.1
million of merger-related expenses.
Net income was $3.4 million for
the three months ended March 31,
2014, as compared to $0.3
million in the prior year period. Diluted EPS for the three
months ended March 31, 2014 was
$0.33.
Selected Balance
Sheet Data
|
(in
thousands)
|
|
|
March
31,
|
December
31,
|
|
2014
|
2013
|
Cash
|
$
51,373
|
$
11,105
|
Non-cash Current
Assets
|
$
16,563
|
$
16,611
|
Total Current
Assets
|
$
67,936
|
$
27,716
|
Current
Liabilities
|
$
4,560
|
$
3,538
|
|
|
|
|
As a result of the follow-on public offering completed during
the quarter, ANI had $51.4 million of
cash at March 31, 2014. ANI's total
current assets increased by $40.2
million to $67.9 million at
March 31, 2014, from $27.7 million at December
31, 2013.
Total shares issued and outstanding at March 31, 2014 were 11,292,215 and 11,282,982,
respectively.
ANI Product
Development Pipeline
|
|
Products
|
|
ANI
|
|
Partnered
|
|
Total
|
At FDA
|
|
5
|
|
1
|
|
6
|
Development
|
|
3
|
|
6
|
|
9
|
Teva
Products
|
|
31
|
|
0
|
|
31
|
ANI's product development pipeline includes extended-release
products, narcotics, anti-cancers, oral solutions, suspensions and
solid dosage forms. These forty-six generic products address a
total annual market size of approximately $2.7 billion, based on data from IMS Health.
Non-GAAP Financial Measures
Adjusted Non-GAAP EBITDA
ANI's management considers adjusted non-GAAP EBITDA to be an
important financial indicator of ANI's operating performance,
providing investors and analysts with a useful measure of operation
results unaffected by non-cash stock-based compensation,
merger-related expenses, and differences in capital structures, tax
structures, capital investment cycles, ages of related assets and
compensation structures among otherwise comparable companies.
Management uses adjusted non-GAAP EBITDA when analyzing Company
performance.
Adjusted non-GAAP EBITDA is defined as operating income/(loss),
excluding depreciation, amortization, stock-based compensation
expense, and merger-related operating expenses. Adjusted
non-GAAP EBITDA should be considered in addition to, but not in
lieu of, net income or loss reported under GAAP. A
reconciliation of adjusted non-GAAP EBITDA to the most directly
comparable GAAP financial measure is provided in Table 2.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing branded and generic prescription
pharmaceuticals. The Company's targeted areas of product
development currently include narcotics, oncolytics (anti-cancers),
hormones and steroids, and complex formulations involving extended
release and combination products. For more information, please
visit our website www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with
information that is not historical, these are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Such statements include, but are not limited
to, statements about the potential benefits of the recent Merger,
the effect of price increases, the Company's plans, objectives,
expectations and intentions with respect to future operations and
products and the timing or success of the introduction thereof, the
anticipated financial position, operating results and growth
prospects of the Company, the value of the Company's pipeline or
the size of potential markets therefor, and other statements that
are not historical in nature, particularly those that utilize
terminology such as "anticipates," "will," "expects," "plans,"
"potential," "future," "believes," "intends," "continue," other
words of similar meaning, derivations of such words and the use of
future dates. Forward-looking statements by their nature address
matters that are, to different degrees, subject to change. You
should not place undue reliance on those statements because they
are subject to numerous uncertainties, risks and other factors
relating to the Company's operations and business environment and
other factors, all of which are difficult to predict and many of
which are beyond the Company's control.
Uncertainties and risks may cause the Company's actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risk that the Company may in the future
face increased difficulty in importing raw materials and/or
increased competition, for its Esterified Estrogen with
Methyltestosterone Tablet product; competitive conditions for the
Company's other products may intensify; the Company may be required
to seek the approval of the U.S. Food and Drug Administration
("FDA") for its unapproved products or withdraw such products from
the market; general business and economic conditions; the Company's
expectations regarding trends in markets for the Company's current
and planned products; the Company's future cash flow and its
ability to support its operations; the Company's ability to obtain
additional financing as needed; the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals
and achieving market acceptance; and the marketing success of the
Company's licensees or sublicensees.
More detailed information on these and additional factors that
could affect the Company's actual results are described in the
Company's filings with the Securities and Exchange Commission,
including its most recent annual report on Form 10-K and quarterly
report on Form 10-Q, as well as its proxy statement/prospectus,
filed with the Securities and Exchange Commission on May 8, 2013. All forward-looking statements in
this news release speak only as of the date of this news release
and are based on the Company's current beliefs, assumptions, and
expectations. ANI undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
For more information about ANI, please contact:
Arthur S. Przybyl
(218) 634-3608
arthur.przybyl@anipharmaceuticals.com
ANI
Pharmaceuticals, Inc. and Subsidiary
|
Table 1: US GAAP
Income Statement
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
Three months
ended
March 31,
|
|
|
|
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$10,899
|
|
$ 5,562
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
Cost of sales (excl. depreciation
and amortization)
|
|
2,622
|
|
2,408
|
|
Research
and development
|
|
376
|
|
296
|
|
Selling,
general and administrative
|
|
3,703
|
|
2,310
|
|
Depreciation and amortization
|
|
703
|
|
145
|
|
|
|
|
|
|
|
Total
Operating Expenses
|
|
7,404
|
|
5,159
|
|
|
|
|
|
|
|
Operating Income
|
|
3,495
|
|
403
|
|
|
|
|
|
|
|
Other
Income/(Expense)
|
|
|
|
|
|
Interest
expense
|
|
-
|
|
(93)
|
|
Other
income/(expense)
|
|
29
|
|
(50)
|
|
|
|
|
|
|
|
Income
Before Income Tax Provision
|
|
3,524
|
|
260
|
|
|
|
|
|
|
|
Income tax
provision
|
|
(165)
|
|
-
|
|
|
|
|
|
|
|
Net
Income
|
|
3,359
|
|
260
|
|
|
|
|
|
|
|
Preferred stock
dividends
|
|
-
|
|
(2,604)
|
|
|
|
|
|
|
|
Income/(Loss)
Attributable to Common Stockholders
|
|
3,359
|
|
(2,344)
|
|
|
|
|
|
|
|
Basic and Diluted
Earnings/(Loss) Per Share:
|
|
|
|
|
|
Basic Earnings/(Loss)
Per Share
|
|
$
0.33
|
|
N/A
(1)
|
|
Diluted
Earnings/(Loss) Per Share
|
|
$
0.33
|
|
N/A
(1)
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
9,991
|
|
N/A
(1)
|
|
Diluted
Weighted-Average Shares Outstanding
|
|
10,001
|
|
N/A
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Earnings/(Loss) per
common share is not calculable because common shareholders from
ANIP
Acquisition Company did not receive consideration from the June 19,
2013 Merger with
BioSante Pharmaceuticals.
|
ANI
Pharmaceuticals, Inc. and Subsidiary
|
Table 2: Adjusted
non-GAAP EBITDA Calculation and US GAAP to Non-GAAP
Reconciliation
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
Three months
ended
March 31,
|
|
|
|
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
Operating
Income
|
|
$3,495
|
|
$403
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
Depreciation and amortization
|
|
703
|
|
145
|
|
|
|
|
|
|
|
Add
back
|
|
|
|
|
|
Stock-based compensation
|
|
47
|
|
-
|
|
Merger-related expenses, not already added
back
|
|
|
|
|
|
Adjusted non-GAAP
EBITDA
|
|
$4,245
|
|
$683
|
|
SOURCE ANI Pharmaceuticals, Inc.