08.05.2008 12:05:00
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APP Pharmaceuticals Reports 2008 First Quarter Net Revenues of $148 Million, Gross Profit of $70 Million
APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of
multi-source and branded injectable pharmaceutical products, today
reported financial results for the first quarter ended March 31, 2008.
As a result of the separation of Abraxis BioScience from APP
Pharmaceuticals, APP’s business is reported,
for all periods presented, on a continuing operations basis and Abraxis
BioScience’s business is reported in
discontinued operations.
"The foundation we have established as a
company has demonstrated our strength and ability to respond effectively
to opportunities in the marketplace,” said Tom
Silberg, APP Pharmaceuticals’ recently named
president and chief executive officer. "We
leveraged our flexible manufacturing capabilities to rapidly increase
the supply of heparin toward the end of the first quarter and avert a
potential market shortage for this critical care product. We expect that
our strong core business, combined with recently introduced and
anticipated new product launches, should contribute to continued revenue
and earnings growth throughout the balance of the year.”
For the 2008 first quarter, net revenues increased 6 percent to $148.1
million, compared with $140.3 million in the first quarter of 2007.
Gross profit was $70.1 million, or 47 percent of net revenues for the
first quarter of 2008, compared with $65.4 million, or 47 percent of net
revenues, in the first quarter of 2007. Excluding $4.1 million for
amortization of purchased products, gross profit was $74.2 million, or
50 percent of net revenues compared with $69.5 million or 50 percent of
net revenues.
Total operating expenses were $37.6 million, compared with $36.2 million
in the 2007 first quarter. Research and development expenses were $12.3
million compared with $10.0 million in last year’s
first quarter. SG&A expenses were $21.0 million, or 14 percent of net
revenues, compared with $22.1 million, or 16 percent of net revenues, in
the prior year first quarter.
Income from operations before interest expense for the 2008 first
quarter increased by 11% to $32.5 million compared with $29.2 million in
the 2007 first quarter. Net interest expense was $15.7 million compared
with $3.6 million in the last year’s first
quarter, primarily reflecting the increase in borrowing following the
separation that was completed in November 2007.
As a result of increased net interest expense, net income was $9.2
million, or $0.06 per diluted share, versus first quarter 2007 net
income of $11.1 million, or $0.07 per diluted share, which includes a
loss from discontinued operations of $2.5 million, or $0.02 per share.
The company reported first quarter adjusted net income from continuing
operations of $22.0 million, or $0.14 per diluted share, which in each
case excludes Puerto Rico facility pre-launch costs, amortization
expense, non-cash stock compensation expense and other items (see table
at the end of this release).
In the first quarter of 2008, APP received final FDA approval on four
products and launched the following Polymixin B Sulfate, Caffeine
Citrate Oral Solution, and Irinotecan Hydrochloride. Additionally, the
company launched Cefepime Hydrochloride.
APP currently has more than 60 product candidates in various stages of
development, including 27 ANDAs pending with the FDA, representing
approximately $5 billion in 2007 annualized branded sales.
Recent Events
On April 21, 2008, the company received FDA approval for Colistimethate
for Injection and has begun marketing and shipping product.
On May 1, 2008, the company appointed Tom Silberg as president and chief
executive officer and Richard Tajak was named chief financial officer.
2008 Financial Guidance
Total net revenues are expected to be in the range of $730 to $750
million;
Gross margin is anticipated to be approximately 50 percent relative to
total net revenues. This excludes $16.4 million in acquired product
portfolio amortization, approximately $10 million of capacity
optimization and product transfer costs related to the Puerto Rico
facility, as well as an additional $7 million that was reclassified to
R&D expense;
R&D expense is now expected to be approximately $47 to $52 million,
which includes the reclassification from gross margin;
SG&A expenses are anticipated to be in the range of $85 to $90
million, which includes expected non-cash stock compensation expense
of $8 to $10 million;
Interest expense is expected to be approximately $58 million;
Income tax rate is now expected to be approximately 45 percent;
Depreciation expense is expected to be approximately $18 to $23
million;
Adjusted EBITDA is expected to be $285 to $300 million. Adjustments
include costs associated with the launch of the Puerto Rico facility,
separation expense, amortization expense and non-cash compensation;
Adjusted EPS is anticipated to be $0.80 to $0.90, which includes
approximately $0.22 per share after-tax interest expense. Adjustments
include costs associated with the launch of the Puerto Rico facility,
separation expense, amortization expense and non-cash compensation.
Conference Call Information
On Thursday, May 8, 2008, the company will host a conference call with
interested parties beginning at 8:30 a.m. PT (11:30 a.m. ET) to review
the company’s financial results. The
conference call will be available to interested parties through a live
audio webcast at www.APPpharma.com
and www.thomsonone.com.
The call will also be archived and accessible at both sites for six
months.
Non-GAAP Financial Measures
The company believes that its presentation of non-GAAP financial
measures, such as adjusted net income, adjusted income from continuing
operations, EBITDA and adjusted EBITDA, provides useful supplementary
information to investors in understanding the underlying operating
performance of the company and facilitates additional analysis by
investors. The company also uses non-GAAP financial measures internally
for operating, budgeting and financial planning purposes. The non-GAAP
financial measures are in addition to, and not a substitute for or
superior to, measures of financial performance calculated in accordance
with GAAP. A reconciliation of GAAP net income to adjusted net income
for the three months ending March 31, 2008 is included with this news
release.
About APP Pharmaceuticals
APP is a specialty drug company that develops, manufactures and markets
injectable pharmaceutical products, focusing on oncology, anti-infective
and critical care markets. The company is one of the largest producers
of injectables, with more than 100 generic products in more than 400
dosage formulations. APP, headquartered in Schaumburg, Illinois, has
offices in Canada and manufacturing operations in Illinois, New York and
Puerto Rico and is traded on the Nasdaq Global Market under the symbol
APPX. For more information about APP and the products it provides,
please visit www.APPpharma.com.
Forward-Looking Statement
The statements contained in this news release that are not purely
historical are forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. Forward-looking
statements in this news release include statements regarding our
expectations, beliefs, hopes, goals, intentions, initiatives or
strategies, including statements regarding financial guidance for 2008
and the development and approval of product candidates. Because these
forward-looking statements involve risks and uncertainties, there are
important factors that could cause actual results to differ materially
from those in the forward- looking statements. These factors include,
but are not limited to, the continued market acceptance and demand of
new and existing products; the difficulties or delays in developing,
testing, obtaining regulatory approval of, and producing and marketing
of the company’s products; the impact of
competitive products and pricing; the availability and pricing of
ingredients used in the manufacture of pharmaceutical products; and the
ability to successfully manufacture products in a time-sensitive and
cost effective manner. Additional relevant information concerning risks
can be found in APP Pharmaceuticals Form 10-K for the year ended
December 31, 2007 and other documents it has filed with the Securities
and Exchange Commission.
The information contained in this news release is as of the date of this
release. APP assumes no obligations to update any forward-looking
statements contained in this news release as the result of new
information or future events or developments.
APP Pharmaceuticals, Inc. Consolidated Statements of Operation (unaudited, in thousands, except per share amounts)
Three Months Ended March 31, 2008 2007
Net revenues:
Critical care
$
91,182
$
84,695
Anti-infective
42,959
39,780
Oncology
11,021
11,277
Contract manufacturing
2,917
4,516
Total net revenues
148,079
140,268
Cost of sales
78,017
74,831
Gross profit
70,062
65,437
Percent to total net revenues 47.3 % 46.7 %
Operating expenses
Research and development
12,330
9,964
Selling, general and administrative
21,020
22,061
Amortization of merger related intangibles
3,856
3,856
Separation related costs
391
352
Total operating expenses
37,597
36,233
Percent to total net revenues 25.4 % 25.8 %
Income from operations
32,465
29,204
Percent to total net revenues 21.9 % 20.8 %
Interest expense and other, net
(15,737
)
(3,610
)
Income from continuing operations before income tax
16,728
25,594
Income tax expense
7,571
11,977
Income from continuing operations, net of income tax
9,157
13,617
Loss from discontinued operations, net of tax
-
(2,502
)
Net income
$
9,157
$
11,115
Basic earnings (loss) per share:
Continuing operations
$
0.06
$
0.09
Discontinued operations
$
-
$
(0.02
)
Net income
$
0.06
$
0.07
Diluted earnings (loss) per share:
Continuing operations
$
0.06
$
0.08
Discontinued operations
$
-
$
(0.01
)
Net income
$
0.06
$
0.07
Weighted - average common shares outstanding:
Basic
160,273
159,356
Diluted
161,222
160,356
Selected ratios as a percentage of total net revenues:
Research and development
8.3
%
7.1
%
Selling, general and administrative
14.2
%
15.7
%
APP Pharmaceuticals, Inc. GAAP to Adjusted Earnings from Continuing Operations
Reconciliation (unaudited, in thousands, except per share amounts)
Adjusted income from continuing operations and adjusted income
from continuing operations per diluted share are defined as income
from continuing operations and diluted earnings from continuing
operations per share, respectively, in each case excluding the
impact of, non-cash stock compensation expense, separation related
costs, amortization of acquired intangible assets and merger
related intangibles and Puerto Rico pre-launch costs. We believe
that our presentation of non-GAAP financial measures provides
useful supplementary information to investors in understanding our
underlying operating performance and facilitates additional
analysis by investors. We also use non-GAAP financial measures
internally for operating, budgeting and financial planning
purposes. The non-GAAP financial measures are in addition to, and
not a substitute for or superior to, measures of financial
performance calculated in accordance with GAAP. A reconciliation
of GAAP income from continuing operations to adjusted income from
continuing operations for the three months ended March 31, 2008 is
below:
March, 31 2008
Income from continuing operations net of income tax
$
9,157
Stock compensation expense
1,862
Intangible amortization
2,739
Separation related costs
241
Amortization of purchased product rights
2,538
Puerto Rico pre-launch costs
5,496
Adjusted income from continuing operations
$
22,033
Adjusted income from continuing operations per diluted share
$
0.14
Weighted - average common shares outstanding diluted
161,222
Income from continuing operations per diluted share
$
0.06
Stock compensation expense
0.01
Minority interests
0.02
Separation related costs
0.00
Amortization of purchased product rights
0.02
Puerto Rico pre-launch costs
0.03
Adjusted income from continuing operations per diluted share
$
0.14
APP Pharmaceuticals, Inc. Reconciliation of Income from Continuing Operations to Adjusted
EBITDA Three Months Ended March 31, 2008 (unaudited, in thousands)
We define Adjusted EBITDA from continuing operations as income
from continuing operations, excluding the impact of depreciation
and amortization, interest expense net of interest income and
other income, income tax expense, non-cash stock-based
compensation expense, separation related costs and pre-launch
costs associated with Puerto Rico manufacturing facility. We use
adjusted EBITDA from continuing operations to provide meaningful
supplemental information to investors in understanding the
underlying operating performance of the business and facilitate
additional analysis by investors. We believe that Adjusted EBITDA
from continuing operations can assist management and investors in
assessing the financial operating performance and underlying
strength of our core business. Adjusted EBITDA from continuing
operations is not a recognized term under GAAP and should not be
considered in isolation of, or as a substitute for, the
information prepared and presented in accordance with GAAP.
Because not all companies calculate Adjusted EBITDA from
continuing operations identically, our definition of Adjusted
EBITDA from continuing operations may not be comparable to
similarly titled measures of other companies.
March, 31 2008
Income from continuing operations net of income tax
$
9,157
Depreciation
4,492
Amortization
7,994
Interest expense, net of interest income
16,245
Provision for income taxes from continuing operations
7,571
EBITDA from continuing operations
45,459
Stock-based compensation expense
3,015
Puerto Rico pre-launch costs, net of depreciation
4,946
Separation related costs
391
Adjusted EBITDA from continuing operations
$
53,811
APP Pharmaceuticals, Inc. Consolidated Condensed Balance Sheets (In thousands)
March 31, December 31, 2008 2007 Assets (Unaudited) (Audited)
Current assets:
Cash and cash equivalents
$
60,837
$
31,788
Accounts receivable, net of allowances
65,303
85,209
Inventories
161,545
149,191
Prepaid expenses and other current assets
11,523
13,531
Current receivables from related parties
-
6,996
Income tax receivable
5,648
-
Deferred income taxes
14,507
17,109
Total current assets
319,363
303,824
Property, plant and equipment, net
131,323
132,528
Intangible assets, net of accumulated amortization
455,659
463,154
Goodwill
160,239
160,239
Deferred financing costs and other non-current assets, net
17,727
17,842
Total assets
$
1,084,311
$
1,077,587
Liabilities and stockholders' deficit
Current liabilities:
Accounts payable
$
34,450
$
36,502
Accrued liabilities
41,662
45,595
Current payable to related parties
3,647
-
Short term portion of long term debt
8,125
5,000
Total current liabilities
87,884
87,097
Long-term debt
990,625
995,000
Deferred income taxes, non-current
69,788
71,011
Other non-current liabilities
11,713
4,250
Total liabilities
1,160,010
1,157,358
Total stockholders' deficit
(75,699
)
(79,771
)
Total liabilities and stockholders' deficit
$
1,084,311
$
1,077,587
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