07.03.2008 13:05:00
|
APP Pharmaceuticals Reports Record Net Revenues of $647 Million and Gross Profit of $315 Million from Continuing Operations in 2007
APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of
multi-source and branded injectable pharmaceutical products, today
reported audited financial results for the fourth quarter and full year
ended December 31, 2007. As a result of the separation of Abraxis
Bioscience from APP Pharmaceuticals, APP’s
business is reported, for all periods reported, on a continuing
operations basis and Abraxis Bioscience’s
business, as well as a majority of separation related costs, is reported
in discontinued operations.
"APP has emerged as a market leading
injectable products company with a sharpened business focus, flexible,
high quality production, and a robust pipeline. With this broad and
growing platform in place, APP expects to produce significant growth in
net revenues and earnings as well as strong cash flow in 2008,”
stated Patrick Soon-Shiong, M.D., Chief Executive Officer and Chairman
of APP Pharmaceuticals.
For 2007, net revenues increased 11 percent to $647.4 million, compared
with $583.2 million in 2006. Gross profit, excluding $16.4 million for
amortization of purchased products, was $331.7 million, or 51 percent of
net revenues. Income from continuing operations, net of income taxes,
grew 49 percent to $82.2 million, or $0.51 per diluted share, from $55.2
million, or $0.35 per diluted share, in 2006. Net income, including
results from discontinued operations, was $34.4 million, or $0.21 per
diluted share, versus a net loss of $46.9 million, or $0.30 per basic
share, in 2006.
The company reported full-year adjusted income from continuing
operations, net of income tax, of $136.2 million and adjusted income
from continuing operations, net of income tax, per diluted share of
$0.85, 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 new release).
Comparison of adjusted income from continuing operations is presented
below:
2007
2006
(millions, except share amounts)
Adjusted income from continuing operations, net of income tax
$136.2
$115.8
Adjusted income from continuing operations, net of income tax, per
diluted share
$0.85
$0.73
On a GAAP basis, the company reported income from continuing operations,
net of income tax; loss from discontinued operations, net of income tax;
and net income; as well as diluted per share amounts, as follows:
2007
2006
(millions, except share amounts)
Income from continuing operations, net of income tax
$82.2
$55.2
Loss from discontinued operations, net of income tax
(47.8)
(102.1)
Net income (loss)
34.4
(46.9)
Income from continuing operations, net of income tax, per diluted
share
0.51
0.35
Discontinued operations, net of income tax, per diluted share
(0.30)
(0.65)
Net income (loss) per diluted share
$0.21
($0.30)
Total operating expenses were $155.2 million, compared with $154.3
million in 2006. Research and development expenses were $46.5 million in
2007, compared with $27.8 million in 2006. This increase is primarily
due to pre-launch activities at the Puerto Rico manufacturing facility.
SG&A expenses in 2007 were $90.2 million, or 14 percent of net revenues,
compared with $80.7 million, or 14 percent of net revenues, in the prior
year.
"APP continues to be a leader in the industry
with 15 drug approvals in 2007 and has increased its capacity with the
addition of commercial production at our Puerto Rico facility,”
said Tom Silberg, president of APP Pharmaceuticals. "Our
team is effectively executing on our dual manufacturing capabilities,
enabling the company to address market needs as they arise. We expect to
remain a market leader in new product approvals while continuing to
build APP’s pipeline and manufacturing
capabilities during 2008.” Fourth Quarter 2007 Financial Results
Net revenues were $194.6 million, compared with $199.7 million in the
fourth quarter of 2006. Gross profit was $101.6 million, or 52 percent
of net revenues, compared with $108.4 million, or 54 percent of net
revenues, in the fourth quarter of 2007.
Income from continuing operations, net of income tax, was $31.7 million,
or $0.20 per diluted share, compared with $35.4 million, or $0.22 per
diluted share, in the 2006 fourth quarter. Adjusted income from
continuing operations, net of income tax, was $45.7 million, or $0.28
per diluted share, compared with $29.4 million, or $0.18 per diluted
share, for the prior year’s fourth quarter.
Net income was $8.5 million, or $0.05 per diluted share, which includes
a loss from discontinued operations of $23.1 million, equal to $0.15 per
diluted share. Net income for the 2006 fourth quarter was $28.4 million,
or $0.18 per diluted share, which includes a loss from discontinued
operations of $6.9 million, equal to $0.04 per diluted share.
Total operating expenses were $41.7 million, compared with $42.6 million
for same quarter in 2006. Research and development expenses were $12.5
million, compared with $10.2 million in the 2006 fourth quarter. SG&A
expenses decreased to $23.4 million, or 12 percent of net revenues,
compared with $27.8 million, or 14 percent of net revenues, in the prior
year’s fourth quarter.
In the fourth quarter of 2007, APP launched liquid and lyophilized
Fludarabine Phosphate as well as four dosage forms of Epirubicin
Hydrochloride Injection. Two of the codes were not previously available
on the market. Epirubicin belongs to a class of drugs called
anthracyclines and is the foundation of many chemotherapy regimens.
APP currently has more than 60 product candidates in various stages of
development, including 30 ANDAs pending with the FDA, representing
approximately $5 billion in 2007 annualized branded sales.
Recent Events
On February 19, 2008, the company announced that, in response to FDA and
hospital concerns about a potential shortage of therapeutic heparin, it
would immediately increase manufacturing of this product. Since that
time, the company has ramped up production to a level the company
believes is sufficient to meet the entire U.S. demand.
In February 2008, APP received approval for Irinotecan Hydrochloride
Injection. The company has secured contracts and begun marketing and
shipping the product.
The FDA inspected and approved the company’s
facility in Puerto Rico for commercial manufacturing. APP has
transferred to this facility and begun manufacturing three products.
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 and approximately $10 million of capacity
optimization and product transfer costs related to Puerto Rico;
R&D expense is expected to be approximately $40 to $45 million. This
includes $10 million for launch costs associated with the Puerto Rico
facility;
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 5.75 percent or approximately $58
million;
Income tax rate is expected to be approximately 37.5 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,
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,
amortization expense and non-cash compensation.
Conference Call Information
On Friday, March 7, 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 and 12 months ending December 31, 2007 and December 31,
2006 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, 2006 filed under the company name Abraxis BioScience, Inc.,
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 December 31, Twelve Months Ended December 31, 2007 2006 2007 2006
Net revenues:
Critical care
$
116,914
$
123,395
$
382,772
$
302,244
Anti-infective
60,143
56,200
193,704
213,490
Oncology
15,381
16,940
55,308
57,872
Contract manufacturing
2,162
3,171
15,590
9,595
Total net revenues
194,600
199,706
647,374
583,201
Cost of sales
92,983
91,259
332,046
288,079
Gross profit
101,617
108,447
315,328
295,122
Percent to total net revenues 52.2 % 54.3 % 48.7 % 50.6 %
Operating expenses
Research and development
12,503
10,158
46,497
27,787
Selling, general and administrative
23,429
27,772
90,229
80,669
Amortization of merger related intangibles
3,849
3,857
15,418
10,926
Separation related costs
1,968
-
3,024
-
Merger-related in-process research and development charge
-
-
-
22,330
Other merger related costs
-
845
-
12,613
Total operating expenses
41,749
42,632
155,168
154,325
Percent to total net revenues 21.5 % 21.3 % 24.0 % 26.5 %
Income from operations
59,868
65,815
160,160
140,797
Percent to total net revenues 30.8 % 33.0 % 24.7 % 24.1 %
Interest expense
(12,414
)
(4,172
)
(25,162
)
(9,186
)
Interest income and other
366
597
2,182
3,557
Minority interests
-
-
-
(11,383
)
Income from continuing operations before income tax
47,820
62,240
137,180
123,785
Income tax expense
16,158
26,877
55,001
68,559
Income from continuing operations net of income tax
31,662
35,363
82,179
55,226
Loss from discontinued operations, net of tax
(23,119
)
(6,914
)
(47,821
)
(102,123
)
Net income (loss)
$
8,543
$
28,449
$
34,358
$
(46,897
)
Basic earnings (loss) per share:
Continuing operations
$
0.20
$
0.22
$
0.51
$
0.35
Discontinued operations
$
(0.15
)
$
(0.04
)
$
(0.29
)
$
(0.65
)
Net income
$
0.05
$
0.18
$
0.22
$
(0.30
)
Diluted earnings (loss) per share:
Continuing operations
$
0.20
$
0.22
$
0.51
$
0.35
Discontinued operations
$
(0.15
)
$
(0.04
)
$
(0.30
)
$
(0.65
)
Net income
$
0.05
$
0.18
$
0.21
$
(0.30
)
Weighted - average common
shares outstanding:
Basic
159,424
159,198
159,643
158,937
Diluted
160,673
160,169
161,006
158,937
The composition of stock-based compensation included above is as
follows:
Cost of sales
$
361
$
168
$
2,502
$
2,668
Research and development
103
234
602
554
Selling, general and administrative
855
3,106
8,977
7,902
Discontinued operations
2,949
7,536
16,517
23,898
Total stock-based compensation
$
4,268
$
11,044
$
28,598
$
35,022
Selected ratios as a percentage of total net revenues:
Research and development
6.4
%
5.1
%
7.2
%
4.8
%
Selling, general and administrative
12.0
%
13.9
%
13.9
%
13.8
%
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 merger-related costs, non-cash stock compensation
expense, minority interests, separation related costs,
amortization of acquired intangible assets 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 each of the
three and twelve months ended December 31, 2007 and 2006 is below:
Three Months Ended December 31, Twelve Months Ended December 31, 2007 2006 2007 2006
Income from continuing operations net of income tax
$
31,662
$
35,363
$
82,179
$
55,226
Merger related items
In-process research and development charge
-
-
-
22,330
Amortization of inventory step-up
-
-
-
7,251
Intangible amortization
2,377
2,382
9,521
6,747
Other merger related costs
-
522
-
7,788
Merger related income tax benefit
-
(17,884
)
-
(17,884
)
Total merger related costs
2,377
(14,981
)
9,521
26,232
Stock compensation expense
814
2,166
7,460
6,869
Minority interests
-
-
-
11,383
Separation related costs
1,215
-
1,867
-
Amortization of purchased product rights
2,538
2,538
10,152
5,076
Puerto Rico pre-launch costs
7,047
4,277
25,007
11,020
Adjusted income from continuing operations
$
45,653
$
29,363
$
136,185
$
115,807
Adjusted income from continuing operations per diluted share
$
0.28
$
0.18
$
0.85
$
0.73
Weighted - average common shares outstanding diluted
160,673
160,169
161,006
158,937
Income from continuing operations per diluted share
$
0.20
$
0.22
$
0.51
$
0.35
Merger related items
In-process Research and Development charge
-
-
-
0.14
Amortization of inventory step-up
-
-
-
0.05
Intangible amortization
0.01
0.1
0.06
0.04
Other merger related costs
-
0.1
-
0.05
Merger related income tax benefit
-
(0.11
)
-
(0.11
)
Total merger related costs
0.01
(0.09
)
0.06
0.17
Stock compensation expense
0.01
0.01
0.05
0.04
Minority interests
-
-
-
0.07
Separation related costs
0.01
-
0.01
-
Amortization of purchased product rights
0.02
0.02
0.06
0.03
Puerto Rico pre-launch costs
0.04
0.03
0.16
0.07
Adjusted income from continuing operations per diluted share
$
0.28
$
0.18
$
0.85
$
0.73
APP Pharmaceuticals, Inc. GAAP to Adjusted Pretax Income from Continuing Operations
Reconciliation (unaudited, in thousands)
Three Months Ended December 31, Twelve Months Ended December 31, 2007 2006 2007 2006
Income from continuing operations before income tax
$
47,820
$
62,240
$
137,180
$
123,786
Pretax merger related items
In-process research and development charge
-
-
-
22,330
Amortization of inventory step-up
-
-
-
11,743
Intangible amortization
3,849
3,857
15,418
10,926
Other merger related costs
-
845
-
12,613
Total pretax merger related costs
3,849
4,702
15,418
57,612
Stock compensation expense
1,319
3,508
12,081
11,124
Minority interests
-
-
-
11,383
Separation related costs
1,968
-
3,024
-
Amortization of purchased product rights
4,110
4,110
16,440
8,220
Puerto Rico pre-launch costs
7,191
4,364
25,517
11,245
Adjusted income from continuing operations before income tax
$
66,257
$
78,924
$
209,660
$
223,370
APP Pharmaceuticals, Inc. Reconciliation of Adjusted Net Income Excluding Items that Impact
Comparability Twelve Months Ended December 31, 2007 and December 31, 2006 (unaudited, in millions, except per share amounts)
In order to reflect our operating results on a comparable basis, we
present adjustments to our financial statement for certain items
that impact comparability. We present these selected items that
impact the comparability of our operating results as additional
information that may be helpful to your understanding of our
financial results. We consider an understanding of these selected
items impacting comparability to be material to our evaluation of
our operating results and prospects. Although we present selected
items that we consider in evaluating our performance, you should
also be aware that the items presented do not represent all items
that affect comparability between the periods presented. Our
financial statements adjusted for these items that impact
comparability are summarized below.
Twelve Months Ended December 31, 2007 Twelve Months Ended December 31, 2006 As Presented Adjustments As Adjusted As Presented Adjustments As Adjusted
Total net revenues
$
647.4
$
647.4
$
583.2
$
583.2
Cost of sales
332.1
(16.4
)
(a)
315.7
288.1
(20.0
)
(a)(d)
268.1
Gross profit
315.3
16.4
331.7
295.1
20.0
315.1
Percent to total net revenues 48.7 % 51.2 % 50.6 % 54.0 %
Operating expenses
Research and development
46.5
(25.5
)
(b)
21.0
27.8
(11.2
)
(b)
16.6
Selling, general and administrative
90.2
(8.7
)
(c)
81.5
80.7
(9.9
)
(c)(f)
70.8
Amortization of merger related intangibles
15.4
(15.4
)
(d)
-
10.9
(10.9
)
(d)
-
Separation related costs
3.0
(3.0
)
(e)
-
-
-
-
Merger-related in-process research and development charge
-
-
22.3
(22.3
)
(d)
-
Other merger related costs
-
-
12.6
(12.6
)
(d)
-
Total operating expenses
155.1
(52.6
)
102.5
154.3
(66.9
)
87.4
Income from operations
160.2
69.0
229.2
140.8
86.9
227.7
Interest expense
(25.2
)
(25.2
)
(9.2
)
(9.2
)
Interest income and other
2.2
2.2
3.6
3.6
Minority interests
-
-
(11.4
)
11.4
(g)
-
Income from continuing operations before income tax
$
137.2
$
69.0
$
206.2
$
123.8
$
98.3
$
222.1
Income tax expense
55.0
17.1
(h)
72.1
68.6
24.6
(h)
93.2
Income from continuing operations net of income tax
$
82.2
$
51.9
$
134.1
$
55.2
$
73.7
$
128.9
Income from continuing operations per diluted share
$
0.51
$
0.83
$
0.35
$
0.81
Income from continuing operations net of income tax
$
134.1
$
128.9
Depreciation
14.6
11.3
Interest expense
25.2
9.2
Interest income and other
(2.2
)
(3.6
)
Income tax expense
72.1
93.2
Stock compensation, net
9.1
9.1
Adjusted EBITDA
$
252.9
$
248.1
(a) Amortization of intangible assets
related to purchased products.
(b) Represents pre-launch expenses related
to Puerto Rico manufacturing facility acquired in March 2007.
(c) Represents costs associated with New
Abraxis that are non-recurring subsequent to separation and non-cash
amortization.
(d) Represents one-time costs associated
with the 2006 merger.
(e) Represents costs associated with the
2007 separation.
(f) Represents non-recurring legal costs of
$3.1 million.
(g) Represents minority interest prior to
2006 merger.
(h) Income tax effect of adjustments.
APP Pharmaceuticals, Inc. Reconciliation of Adjusted Net Income Excluding Items that Impact
Comparability (Continued) Twelve Months Ended December 31, 2007 and December 31, 2006 (unaudited, in millions, except per share amounts)
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, merger related in-process
research and development charge, non-cash stock compensation
expense, merger costs, pre-launch costs associated with Puerto
Rico manufacturing facility, separation related costs and minority
interests. 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.
APP Pharmaceuticals, Inc. Consolidated Condensed Balance Sheets (In thousands)
December 31, December 31, 2007 2006(1) Assets (Unaudited)
Current assets:
Cash and cash equivalents
$
31,788
$
38,797
Short-term investments
-
500
Accounts receivable, net of allowances for doubtful accounts
85,209
84,684
Inventories
149,191
218,280
Prepaid expenses and other current assets
13,287
15,570
Current receivables from related parties
6,996
-
Deferred income taxes
17,109
27,168
Total current assets
303,580
384,999
Property, plant and equipment, net
132,528
217,819
Investment in Drug Source Company, LLC
-
5,504
Intangible assets, net of accumulated amortization
463,154
738,440
Goodwill
160,239
401,600
Non-current receivables from related parties
-
39
Deferred financing costs and other non-current assets, net of
accumulated amortization
17,842
25,320
Total assets
$
1,077,343
$
1,773,721
Liabilities and stockholders' equity
Current liabilities:
Accounts payable
$
36,502
$
65,471
Accrued liabilities
45,595
61,428
Income tax payable
2,850
80,054
Deferred revenue
-
39,225
Minimum royalties payable
-
1,017
Notes payable
-
72,248
Short term portion of debt note payable
5,000
-
Total current liabilities
89,947
319,443
Long-term debt
995,000
165,000
Deferred income taxes, non-current
71,011
90,776
Long-term portion of deferred revenue
-
158,135
Other non-current liabilities
1,156
7,006
Total liabilities
1,157,114
740,360
Total stockholders' equity
(79,771
)
1,033,361
Total liabilities and stockholders' equity
$
1,077,343
$
1,773,721
(1) Includes the combined balances of APP
Pharmaceuticals, Inc. and Abraxis Bioscience.
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JETZT DEVISEN-CFDS MIT BIS ZU HEBEL 30 HANDELN
Handeln Sie Devisen-CFDs mit kleinen Spreads. Mit nur 100 € können Sie mit der Wirkung von 3.000 Euro Kapital handeln.
82% der Kleinanlegerkonten verlieren Geld beim CFD-Handel mit diesem Anbieter. Sie sollten überlegen, ob Sie es sich leisten können, das hohe Risiko einzugehen, Ihr Geld zu verlieren.
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