| |
|
|
|
|
|
| |
King Pharmaceuticals Reports Second-Quarter 2008 Financial Results Thursday, August 07, 2008 7:02 AM
Symbols: KG
Highlighted by Significant Advances And Investments in the
Development Pipeline
King Pharmaceuticals, Inc. (NYSE:KG) announced today that total revenues
were $397 million during the second quarter ended June 30, 2008,
compared to $543 million in the second quarter of 2007. This decrease
was primarily due to the market entry of generic substitutes for ALTACE®
(ramipril). Reported net earnings equaled $43 million and diluted
earnings per share equaled $0.18 during the second quarter of 2008,
compared to net earnings of $65 million and diluted earnings per share
of $0.26 in the second quarter of the prior year. Excluding special
items, net earnings equaled $73 million and diluted earnings per share
equaled $0.30 during the second quarter ended June 30, 2008, reflecting
a record high research and development investment of $49 million, which
included development milestones of $21 million. Excluding special items,
in the second quarter of 2007 net earnings equaled $117 million and
diluted earnings per share equaled $0.48.
Brian A. Markison, Chairman, President and Chief Executive Officer of
King, stated, “We are particularly pleased by
the AVINZA® total
prescription growth of 5.2% versus the same quarter of last year and the
continued strong performance of THROMBIN-JMI®.”
Mr. Markison continued, “More importantly, we
remain on track to attain our goal of three New Drug Application (NDA)
submissions to the U.S. Food and Drug Administration (FDA) by the end of
this year. Once approved, these new products have the potential to
provide significant value for patients, society and our shareholders.”
King, through its partner, Pain Therapeutics, submitted a New Drug
Application for REMOXY® (long-acting
oral oxycodone) to the FDA in June. Also in June, King and Acura
Pharmaceuticals reported positive top-line data from the pivotal Phase
III clinical trial for ACUROX™
(short-acting oral oxycodone HCl, niacin, and other functional inactive
ingredients). Based on these positive results, King and Acura plan to
submit the NDA for ACUROX™
by the end of this year. King also expects to file an NDA for CORVUE™
(binodenoson, a pharmacologic stress imaging agent for injection) during
that same period.
As of June 30, 2008, the Company’s cash and
cash equivalents totaled approximately $1.1 billion. During the second
quarter of 2008, the Company generated cash flow from operations of
approximately $138 million.
In addition, the fair value of King’s total
investments in debt securities equaled approximately $432 million as of
the end of the second quarter of 2008. The Company has classified its
investments in debt securities associated with municipal bonds as
current assets as of June 30, 2008, because the Company believes that it
is reasonable to expect that these securities will convert to cash
within one year. The Company has classified its investments in debt
securities associated with student loans, which as of June 30, 2008 had
a fair value of $334 million, as long-term assets.
Net revenue from branded pharmaceuticals totaled $316 million for the
second quarter of 2008, compared to $467 million during the second
quarter of 2007.
Net sales of SKELAXIN®
(metaxalone) totaled $107 million during the second quarter of 2008,
compared to $108 million during the same period of the prior year.
THROMBIN-JMI®
(thrombin, topical, bovine, USP) net sales totaled $64 million during
the second quarter of 2008, compared to $65 million during the second
quarter of 2007.
Net sales of AVINZA®
(morphine sulfate extended release) totaled $35 million during each of
the second quarters of 2008 and 2007.
LEVOXYL®
(levothyroxine sodium tablets, USP) net sales totaled $20 million during
the second quarter ended June 30, 2008, compared to $26 million during
the second quarter of 2007.
ALTACE® net sales
totaled $44 million during the second quarter of 2008, compared to $163
million during the second quarter of 2007.
King’s Meridian Auto-Injector business
contributed revenue of $55 million during the second quarter of 2008,
compared to $51 million during the same period of the prior year.
Royalty revenues, derived primarily from ADENOSCAN®
(adenosine), totaled $24 million during the second quarter ended June
30, 2008, compared to $20 million during the second quarter of last year.
About REMOXY®
REMOXY® is an
innovative long-acting, controlled release formulation of oxycodone for
moderate to severe chronic pain that is currently in development. REMOXY®
uses extraction resistant technology (XRT™),
a unique physical barrier that is designed to provide controlled pain
relief and resist common methods used to extract the opioid more rapidly
than intended as seen with currently available products. Common methods
used to cause a rapid extraction of the opioid include crushing,
chewing, or dissolution in alcohol. These methods are typically used to
cause failure of the controlled release dosage form, resulting in ‘dose
dumping’ of oxycodone, or the immediate
release of the active drug. If approved, the Companies believe REMOXY®
could be the first oxycodone on the market that has the potential to
reduce the risk of misuse and abuse. REMOXY®
is a proposed brand name that is subject to FDA approval.
About ACUROX™ Tablets
ACUROX™ Tablets, an investigational drug, is
an orally administered immediate-release tablet containing oxycodone HCl
as an active analgesic ingredient, niacin as an active ingredient in
subtherapeutic amounts, and a proprietary composition of functional
inactive ingredients. ACUROX™ Tablets are
intended to relieve moderate to severe pain while resisting or deterring
common methods of prescription drug misuse and abuse, including
intravenous injection of dissolved tablets, nasal snorting of crushed
tablets and intentional swallowing of excessive numbers of tablets.
ACUROX™ is a proposed brand name subject to
FDA approval.
Webcast Information
King will conduct a webcast today which may include discussion of the
Company’s marketed products, pipeline,
strategy for growth, financial results and expectations, and other
matters relating to its business. Interested persons may listen to the
webcast on Thursday, August 7, 2008, at 11:00 a.m., E.D.T., by clicking
the following link to register and then joining the live event with the
same URL:
http://www.kingpharm.com/web_casts.asp
If you are unable to participate during the live event, the webcast will
be archived on King’s web site at the same
link for not less than 30 days after the webcast.
About Special Items
Under Generally Accepted Accounting Principles (“GAAP”),
reported “net earnings”
and “diluted earnings per share”
include special items. In addition to the reported results determined in
accordance with GAAP, King provides its net earnings and diluted
earnings per share results for the quarters and six months ended June
30, 2008 and 2007, excluding special items. These non-GAAP financial
measures exclude special items which are those particular material
income or expense items that King considers to be unrelated to the
Company’s ongoing, underlying business,
non-recurring, or not generally predictable. Such items include, but are
not limited to, merger and restructuring expenses; non-capitalized
expenses associated with acquisitions, such as in-process research and
development charges and inventory valuation adjustment charges; charges
resulting from the early extinguishment of debt; asset impairment
charges; expenses of drug recalls; and gains and losses resulting from
the divestiture of assets. King believes the identification of special
items enhances the analysis of the Company’s
ongoing, underlying business and the analysis of the Company’s
financial results when comparing those results to that of a previous or
subsequent like period. However, it should be noted that the
determination of whether to classify an item as a special item involves
judgments by King’s management. A
reconciliation of non-GAAP financial measures referenced herein and King’s
reported financial results determined in accordance with GAAP is
provided below.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and
acquisitions, of novel branded prescription pharmaceutical products and
technologies that complement the Company’s
focus in specialty-driven markets, particularly neuroscience, hospital
and acute care. King strives to be a leader and partner of choice in
bringing innovative, clinically-differentiated medicines and
technologies to market.
Forward-looking Statements
This release contains forward-looking statements which reflect management’s
current views of future events and operations, including, but not
limited to, statements pertaining to the expected timetable for REMOXY®,
ACUROX™ Tablets
and CORVUE™ NDA submissions with the FDA and
the potential of these product to add value once approved; statements
pertaining to the expectation that the Company’s
investments in debt securities associated with municipal bonds may
convert to cash within one year; and statements pertaining to the Company’s
planned webcast to discuss its second-quarter 2008 results. These
forward-looking statements involve certain significant risks and
uncertainties, and actual results may differ materially from the
forward-looking statements. Some important factors which may cause
actual results to differ materially from the forward-looking statements
include dependence on the future level of demand for and net sales of
King’s branded pharmaceutical products;
dependence on King’s ability to successfully
market its branded pharmaceutical products; dependence on King’s
ability to increase its presence in its targeted, specialty-driven
markets; dependence on the Company’s ability
to continue to advance the development of its pipeline products as
planned; dependence on the high cost and uncertainty of research,
clinical trials, and other development activities involving
pharmaceutical products in which King has an interest; dependence on
whether the NDAs for REMOXY®,
ACUROX™ Tablets
and CORVUE™ are submitted to the FDA during
the planned timeframe; dependence on the unpredictability of the
duration and results of the FDA’s review of
Investigational New Drug applications (“IND”),
NDAs, and Abbreviated New Drug Applications (“ANDA”)
and/or the review of other regulatory agencies worldwide that relate to
projects in King’s development pipeline;
dependence on the extent to which continued instability in the credit
markets affects King’s ability to liquidate
its investments in debt securities associated with municipal bonds;
dependence on the availability and cost of raw materials; dependence on
no material interruptions in supply by contract manufacturers of King’s
products; dependence on the potential effect on sales of the Company’s
existing branded pharmaceutical products as a result of the potential
development and approval of a generic substitute for any such product or
other new competitive products; dependence on the potential effect of
future acquisitions and other transactions pursuant to the Company’s
growth strategy; dependence on King’s
compliance with FDA and other government regulations that relate to the
Company’s business; dependence on King’s
ability to conduct its webcast as currently planned on August 7, 2008;
dependence on changes in general economic and business conditions;
changes in current pricing levels; changes in federal and state laws and
regulations; changes in competition; unexpected changes in technologies
and technological advances; and manufacturing capacity constraints.
Other important factors that may cause actual results to differ
materially from the forward-looking statements are discussed in the “Risk
Factors” section and other sections of King’s
Form 10-K for the year ended December 31, 2007 and Form 10-Q for the
quarter ended March 31, 2008, which are on file with the U.S. Securities
and Exchange Commission. King does not undertake to publicly update or
revise any of its forward-looking statements even if experience or
future changes show that the indicated results or events will not be
realized.
|
KING PHARMACEUTICALS, INC.
|
|
CONSOLIDATED BALANCE SHEETS
|
|
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
1,095,549
|
|
|
$
|
20,009
|
|
Investments in debt securities
|
|
|
|
|
97,952
|
|
|
|
1,344,980
|
|
Marketable securities
|
|
|
|
|
1,078
|
|
|
|
1,135
|
|
Accounts receivable, net
|
|
|
|
|
169,040
|
|
|
|
183,664
|
|
Inventories
|
|
|
|
|
104,899
|
|
|
|
110,308
|
|
Deferred income tax assets
|
|
|
|
|
94,171
|
|
|
|
100,138
|
|
Income tax receivable
|
|
|
|
|
-
|
|
|
|
20,175
|
|
Prepaid expenses and other current assets
|
|
|
|
|
39,216
|
|
|
|
39,245
|
|
Total current assets
|
|
|
|
|
1,601,905
|
|
|
|
1,819,654
|
|
Property, plant and equipment, net
|
|
|
|
|
264,439
|
|
|
|
257,093
|
|
Intangible assets, net
|
|
|
|
|
674,521
|
|
|
|
780,974
|
|
Goodwill
|
|
|
|
|
129,150
|
|
|
|
129,150
|
|
Deferred income tax assets
|
|
|
|
|
364,700
|
|
|
|
343,700
|
|
Investments in debt securities
|
|
|
|
|
334,082
|
|
|
|
-
|
|
Other assets
|
|
|
|
|
88,657
|
|
|
|
96,251
|
|
Total assets
|
|
|
|
$
|
3,457,454
|
|
|
$
|
3,426,822
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
$
|
65,197
|
|
|
$
|
76,481
|
|
Accrued expenses
|
|
|
|
|
278,564
|
|
|
|
376,604
|
|
Income taxes payable
|
|
|
|
|
17,149
|
|
|
|
-
|
|
Total current liabilities
|
|
|
|
|
360,910
|
|
|
|
453,085
|
|
|
|
|
|
|
|
|
|
Long-term debt
|
|
|
|
|
400,000
|
|
|
|
400,000
|
|
Other liabilities
|
|
|
|
|
61,947
|
|
|
|
62,980
|
|
Total liabilities
|
|
|
|
|
822,857
|
|
|
|
916,065
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
Shareholders’ equity:
|
|
|
|
|
|
|
|
Common shares no par value, 600,000,000 shares authorized,
246,481,982 and 245,937,709 shares issued and outstanding,
respectively
|
|
|
|
|
|
|
|
|
|
|
|
1,297,974
|
|
|
|
1,283,440
|
|
Retained earnings
|
|
|
|
|
1,356,014
|
|
|
|
1,225,360
|
|
Accumulated other comprehensive (loss) income
|
|
|
|
|
(19,391
|
)
|
|
|
1,957
|
|
Total shareholders’ equity
|
|
|
|
|
2,634,597
|
|
|
|
2,510,757
|
|
Total liabilities and shareholders’
equity
|
|
|
|
$
|
3,457,454
|
|
|
$
|
3,426,822
|
|
KING PHARMACEUTICALS, INC.
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(in thousands, except per share data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
2008
|
|
|
|
2007
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
396,851
|
|
|
$
|
542,726
|
|
|
$
|
828,884
|
|
|
$
|
1,058,756
|
|
|
OPERATING COSTS AND EXPENSES:
|
|
|
|
|
|
|
|
|
|
Cost of revenues, exclusive of depreciation, amortization and
impairments shown below
|
|
|
99,556
|
|
|
|
121,685
|
|
|
|
191,017
|
|
|
|
233,139
|
|
|
Excess purchase commitment
|
|
|
2,629
|
|
|
|
-
|
|
|
|
2,629
|
|
|
|
-
|
|
|
Contract termination
|
|
|
-
|
|
|
|
3,845
|
|
|
|
-
|
|
|
|
3,845
|
|
|
Total cost of revenues
|
|
|
102,185
|
|
|
|
125,530
|
|
|
|
193,646
|
|
|
|
236,984
|
|
|
Selling, general and administrative, exclusive of co-promotion fees
|
|
|
102,735
|
|
|
|
127,316
|
|
|
|
211,776
|
|
|
|
248,526
|
|
|
Special legal and professional fees
|
|
|
(825
|
)
|
|
|
(1,632
|
)
|
|
|
2,035
|
|
|
|
(488
|
)
|
|
Co-promotion fees
|
|
|
10,063
|
|
|
|
47,524
|
|
|
|
28,020
|
|
|
|
93,482
|
|
|
Total selling, general, and administrative expense
|
|
|
111,973
|
|
|
|
173,208
|
|
|
|
241,831
|
|
|
|
341,520
|
|
|
Depreciation and amortization
|
|
|
31,154
|
|
|
|
38,912
|
|
|
|
90,229
|
|
|
|
73,090
|
|
|
Accelerated depreciation
|
|
|
651
|
|
|
|
1,500
|
|
|
|
1,274
|
|
|
|
3,000
|
|
|
Research and development
|
|
|
48,662
|
|
|
|
37,355
|
|
|
|
77,170
|
|
|
|
69,626
|
|
|
Research and development-In-process upon acquisition
|
|
|
5,500
|
|
|
|
3,100
|
|
|
|
5,500
|
|
|
|
3,100
|
|
|
Asset impairments
|
|
|
39,429
|
|
|
|
74,810
|
|
|
|
39,429
|
|
|
|
74,810
|
|
|
Restructuring charges
|
|
|
(542
|
)
|
|
|
-
|
|
|
|
517
|
|
|
|
460
|
|
|
Total operating costs and expenses
|
|
|
339,012
|
|
|
|
454,415
|
|
|
|
649,596
|
|
|
|
802,590
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING INCOME
|
|
|
57,839
|
|
|
|
88,311
|
|
|
|
179,288
|
|
|
|
256,166
|
|
|
OTHER INCOME (EXPENSE):
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(1,838
|
)
|
|
|
(1,853
|
)
|
|
|
(3,642
|
)
|
|
|
(3,878
|
)
|
|
Interest income
|
|
|
9,261
|
|
|
|
8,517
|
|
|
|
22,890
|
|
|
|
17,783
|
|
|
Other, net
|
|
|
(123
|
)
|
|
|
278
|
|
|
|
(827
|
)
|
|
|
(265
|
)
|
|
Total other income
|
|
|
7,300
|
|
|
|
6,942
|
|
|
|
18,421
|
|
|
|
13,640
|
|
|
INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAXES
|
|
|
65,139
|
|
|
|
95,253
|
|
|
|
197,709
|
|
|
|
269,806
|
|
|
Income tax expense
|
|
|
22,118
|
|
|
|
30,394
|
|
|
|
67,055
|
|
|
|
88,893
|
|
|
INCOME FROM CONTINUING OPERATIONS
|
|
|
43,021
|
|
|
|
64,859
|
|
|
|
130,654
|
|
|
|
180,913
|
|
|
DISCONTINUED OPERATIONS
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations
|
|
|
-
|
|
|
|
(115
|
)
|
|
|
-
|
|
|
|
(335
|
)
|
|
Income tax benefit
|
|
|
-
|
|
|
|
(41
|
)
|
|
|
-
|
|
|
|
(120
|
)
|
|
Total loss from discontinued operations
|
|
|
-
|
|
|
|
(74
|
)
|
|
|
-
|
|
|
|
(215
|
)
|
|
NET INCOME
|
|
$
|
43,021
|
|
|
$
|
64,785
|
|
|
$
|
130,654
|
|
|
$
|
180,698
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share
|
|
$
|
0.18
|
|
|
$
|
0.27
|
|
|
$
|
0.54
|
|
|
$
|
0.74
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share
|
|
$
|
0.18
|
|
|
$
|
0.26
|
|
|
$
|
0.53
|
|
|
$
|
0.74
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in basic net income per share
|
|
|
243,440
|
|
|
|
242,746
|
|
|
|
243,365
|
|
|
|
242,568
|
|
|
Shares used in diluted net income per share
|
|
|
245,029
|
|
|
|
244,550
|
|
|
|
244,859
|
|
|
|
244,110
|
|
|
KING PHARMACEUTICALS, INC.
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
EXCLUDING SPECIAL ITEMS - NON GAAP
|
|
(in thousands, except per share data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
2008
|
|
|
|
2007
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
396,851
|
|
|
$
|
542,726
|
|
|
$
|
828,884
|
|
|
$
|
1,058,756
|
|
|
OPERATING COSTS AND EXPENSES:
|
|
|
|
|
|
|
|
|
|
Cost of revenues, exclusive of depreciation and amortization shown
below
|
|
|
99,556
|
|
|
|
121,685
|
|
|
|
191,017
|
|
|
|
233,139
|
|
|
Selling, general and administrative, exclusive of co-promotion fees
|
|
|
102,735
|
|
|
|
127,316
|
|
|
|
211,776
|
|
|
|
248,526
|
|
|
Co-promotion fees
|
|
|
10,063
|
|
|
|
47,524
|
|
|
|
28,020
|
|
|
|
93,482
|
|
|
Total selling, general, and administrative expense
|
|
|
112,798
|
|
|
|
174,840
|
|
|
|
239,796
|
|
|
|
342,008
|
|
|
Depreciation and amortization
|
|
|
31,154
|
|
|
|
38,912
|
|
|
|
90,229
|
|
|
|
73,090
|
|
|
Research and development
|
|
|
48,662
|
|
|
|
37,355
|
|
|
|
77,170
|
|
|
|
69,626
|
|
|
Total operating costs and expenses
|
|
|
292,170
|
|
|
|
372,792
|
|
|
|
598,212
|
|
|
|
717,863
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING INCOME
|
|
|
104,681
|
|
|
|
169,934
|
|
|
|
230,672
|
|
|
|
340,893
|
|
|
OTHER INCOME (EXPENSE):
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(1,838
|
)
|
|
|
(1,853
|
)
|
|
|
(3,642
|
)
|
|
|
(3,878
|
)
|
|
Interest income
|
|
|
9,261
|
|
|
|
8,517
|
|
|
|
22,890
|
|
|
|
17,783
|
|
|
Other, net
|
|
|
(123
|
)
|
|
|
| | | |