26.07.2007 11:30:00
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Celgene Reports Record Second Quarter Product Sales and Operating Profits
Celgene Corporation (NASDAQ: CELG) announced adjusted net income of
$110.4 million, or adjusted earnings per diluted share of $0.26 for the
quarter ended June 30, 2007. Based on U.S. Generally Accepted Accounting
Principles (GAAP), Celgene reported net income of $54.9 million, or
diluted earnings per share of $0.13 for the quarter ended June 30, 2007,
including after-tax share-based employee compensation expense of $12.7
million, compared to net income in the prior year period of $9.6 million
or diluted earnings per share of $0.03, including after-tax share-based
employee compensation expense of $20.7 million. Total revenue was a
record $347.9 million for the quarter ended June 30, 2007, an increase
of 76.4% over the same period in 2006. The increase in total revenue was
driven by REVLIMID net sales of $180.9 million, an increase of 187.2%
over the same period in 2006. THALOMID® net sales reached $117.7 million. ALKERAN®
net sales for the second quarter of 2007 were $18.7 million compared to
$4.5 million in the second quarter of 2006. Revenue from Focalin™
and the Ritalin®
family of drugs totaled $24.8 million for the second quarter of 2007
compared to $17.7 million over the same period last year.
For the six-month period of 2007, total revenue was a record $641.3
million, an increase of 69.2% year-over-year. Total net product sales
reached a record $588.7 million, an increase of 74.9% year-over-year.
REVLIMID net sales for the six-month period of 2007 reached $327.2
million compared to $95.5 million in 2006. THALOMID net sales for the
six-month period of 2007 were $223.7 million compared to $214.4 million
in 2006. Celgene posted adjusted net income of $196.1 million or
adjusted earnings per diluted share of $0.46 during the six-month period
of 2007, compared to adjusted net income of $76.2 million or adjusted
earnings per diluted share of $0.20 for the six-month period of 2006.
For the six-month period of 2007 on a U.S. GAAP basis, Celgene reported
net income of $112.3 million or earnings per diluted share of $0.27,
compared to net income of $25.6 million or earnings per diluted share of
$0.07 in 2006.
See the attached Condensed Consolidated Statements of Operations and
Reconciliation of GAAP Earnings to Adjusted Earnings for an explanation
of the amounts excluded and included to arrive at adjusted net income,
adjusted per share amounts and adjusted pro-forma income tax rate, for
the three-month and six-month periods ended June 30, 2007 and 2006.
Adjusted or Non-GAAP financial measures provide investors and management
with supplemental measures of operating performance and trends that
facilitate comparisons between periods before, during and after certain
items that would not otherwise be apparent on a GAAP basis. Certain
unusual or non-recurring items that management does not believe affect
the Company’s basic operations do not meet
the GAAP definition of unusual or non-recurring items. Adjusted net
income and adjusted earnings per share are not, and should not be viewed
as a substitute for similar GAAP items. We define adjusted diluted
earnings per share amounts as adjusted net income divided by the GAAP
weighted average number of diluted shares outstanding. Our definition of
adjusted net income and adjusted diluted earnings per share may differ
from similarly named measures used by others.
To support clinical development and to advance global regulatory filings
the Company increased R&D investments in multiple international clinical
programs evaluating REVLIMID®
and other IMIDs®
compounds. For the second quarter of 2007, the Company incurred adjusted
R&D expenses of $86.6 million. These R&D expenditures support ongoing
clinical progress in multiple proprietary development programs for
REVLIMID and other IMiDs compounds; for our lead oral anti-inflammatory
compounds; our pleiotropic pathway modifier program; as well as our
kinase and ligase inhibitor programs and placental-derived stem cell
program. On a GAAP basis, R&D expenses were $89.9 million for the second
quarter of 2007.
Adjusted selling, general and administrative expenses increased to
$103.3 million for the second quarter in 2007. SG&A include increased
spending for marketing and sales expenses related to product launch
activities in Europe and continued expansion of Celgene International in
nearly 35 countries, including Europe, Japan, Australia and Canada.
Marketing and sales expenses are expected to remain flat in the third
and fourth quarters of 2007. On a reported GAAP basis, selling, general
and administrative expenses were $114.0 million for the second quarter
in 2007.
For the quarter ended June 30, 2007, adjusted net interest and other net
income (expense) increased to $23.6 million from $7.7 million over the
same period in 2006.
Celgene reported more than $2.3 billion in cash and marketable
securities as of June 30, 2007, an increase of $207 million over the
sequential quarter ended March 31, 2007.
"This was a historic quarter by all measures
underscored by extraordinary financial and operational results,”
said Celgene Chairman and Chief Executive Officer Sol J. Barer. "We
are building a world leading hematology-oncology Company with a major
presence in inflammatory diseases. As a result of the strong momentum
established in the second quarter we have made significant progress
towards accomplishing that mission."
Webcast
Celgene will host a conference call to discuss the results and
achievements of its second quarter 2007 operating and financial
performance on July 26, 2007 at 9:00 a.m. EDT. The conference call will
be available by webcast at www.celgene.com.
An audio replay of the call will be available from noon EDT July 26,
2007 until midnight EDT August 2, 2007. To access the replay, dial
1-888-203-1112 and enter reservation number 5815904. The Company’s
third quarter 2007 financial and operational results will be reported on
Thursday, October 25, 2007.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of novel therapies for the
treatment of cancer and inflammatory diseases through gene and protein
regulation. For more information, please visit the Company's website at www.celgene.com.
This release contains certain forward-looking statements which
involve known and unknown risks, delays, uncertainties and other factors
not under the Company's control, which may cause actual results,
performance or achievements of the Company to be materially different
from the results, performance or other expectations implied by these
forward-looking statements. These factors include results of current or
pending research and development activities, actions by the FDA and
other regulatory authorities, and those factors detailed in the
Company's filings with the Securities and Exchange Commission such as
Form 10-K, 10-Q and 8-K reports. Celgene Corporation and Subsidiaries Condensed Consolidated Statement of Operations and Reconciliation of GAAP Earnings to Adjusted Earnings (Unaudited) (In thousands, except per share data)
Three Months Ended Three Months Ended June 30, 2007 June 30, 2006 GAAP Adjustments(1) "Adjusted" GAAP Adjustments(1) "Adjusted"
Net product sales
$ 318,945
$ 318,945
$ 176,401
$ 176,401
Collaborative agreements and other revenue
5,100
5,100
4,323
4,323
Royalty revenue
23,862
23,862
16,515
16,515
Total revenue
347,907
347,907
197,239
197,239
Cost of goods sold
28,701
(408)
(2)
28,293
26,799
(461)
(2)
26,338
Research and development
89,934
(3,343)
(2)
86,591
57,018
(3,401)
(2)
53,617
Selling, general and administrative
113,986
(10,674)
(2) (3)
103,312
83,036
(19,116)
(2) (3)
63,920
Total costs and expenses
232,621
(14,425)
218,196
166,853
(22,978)
143,875
Operating income
115,286
14,425
129,711
30,386
22,978
53,364
Equity in losses (income) of affiliated companies
949
(1,060)
(4)
(111)
1,375
(1,375)
(4)
-
Interest and other income (expense), net
18,757
4,803
(2) (5)
23,560
7,332
378
(5)
7,710
Income before taxes
133,094
20,288
153,382
36,343
24,731
61,074
Income tax provision (benefit)
78,224
(35,277)
(6)
42,947
26,735
(8,211)
(6)
18,524
Net income
$ 54,870
$ 55,565
110,435
$ 9,608
$ 32,942
$ 42,550
Per common share:
Net income - basic
$ 0.14
$ 0.15
(7)
$ 0.29
$ 0.03
$ 0.09
(7)
$ 0.12
Net income - diluted
$ 0.13
$ 0.13
(7)
$ 0.26
$ 0.03
$ 0.08
(7)
$ 0.11
Weighted average shares outstanding-basic
381,086
381,086
347,696
347,696
Weighted average shares outstanding-diluted
431,377
431,377
370,360
403,381
Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings
(1)
Adjusted net income and adjusted per share amounts for the
three-month periods ended June 30, 2007 and 2006 eliminate the
effects of charges for share-based employee compensation expense
associated with the application of the Statement of Financial
Accounting Standards, or SFAS, No. 123 (revised 2004),
"Share-Based Payment", or SFAS 123(R). The after tax net impact of
share-based employee compensation expense reduced GAAP net income
by $12.7 million, or $0.03 per diluted share, for the three-month
period ended June 30, 2007 and $14.2 million, or $0.03 per diluted
share, for the three-month period ended June 30, 2006. Adjusted
net income and per share amounts for the three-month periods ended
June 30, 2007 and 2006 also exclude amortization of acquisition
intangibles resulting from the acquisition of Penn T Limited,
charges to record our share of equity losses in EntreMed, Inc.,
charges recorded for changes in the estimated value of our
investment in EntreMed, Inc. warrants and adjustments to the
income tax provision to reflect an estimated pro-forma income tax
rate. Also, the three-month period ended June 30, 2006 excludes
accelerated depreciation expense related to the Company's
corporate headquarters relocation. See below for a description of
line item adjustments.
Line Item Adjustments:
(2)
To exclude SFAS 123(R) share-based compensation expense totaling
$16,981 and $20,717 for the three-month periods ended June 30, 2007
and 2006, respectively.
(3)
To exclude the amortization of acquisition intangibles resulting
from the acquisition of Penn T Limited in the amount of $2,250 in
2007 and $2,160 in 2006 and to exclude accelerated depreciation
expense related to the relocation of the Company's corporate
headquarters in the amount of $101 in 2006.
(4)
To exclude the Company's share of equity losses in EntreMed, Inc.
(5)
To exclude the charge recorded for changes in the estimated value of
the Company's investment in EntreMed, Inc. warrants.
(6)
The adjusted income tax provision reflects an annualized 28.0%
estimated pro-forma income tax rate for 2007 and a 32.0% estimated
pro-forma income tax rate for 2006. The tax rates for both years
was computed by taking the Company's GAAP earnings in each taxable
jurisdiction in which the Company operates and making adjustments
required to arrive at taxable income ("book-tax adjustments").
Taxable income is increased to add-back the tax deduction for the
exercise of employee stock options. In jurisdictions where net
operating losses are available for carry forward, taxable income
is reduced by the amount of net operating loss carry forwards that
the Company believes will be deductible and sustainable upon
audit. Taxable income, after the adjustments for employee stock
options and net operating loss carryforwards, is multiplied by the
applicable statutory tax rate to arrive at estimated taxes due.
Estimated taxes due are divided by the Company's adjusted income
before taxes to arrive at the pro-forma income before taxes to
arrive at the pro-forma income tax rates.
(7)
Adjusted per share amounts represent adjusted net income divided by
the GAAP weighted average number of shares outstanding.
Celgene Corporation and Subsidiaries Condensed Consolidated Statement of Operations and Reconciliation of GAAP Earnings to Adjusted Earnings (Unaudited) (In thousands, except per share data)
Six Months Ended Six Months Ended June 30, 2007 June 30, 2006 GAAP Adjustments(1) "Adjusted" GAAP Adjustments(1) "Adjusted"
Net product sales
$
588,741
$
588,741
$
336,644
$
336,644
Collaborative agreements and other revenue
9,904
9,904
8,216
8,216
Royalty revenue
42,677
42,677
34,220
34,220
Total revenue
641,322
-
641,322
379,080
-
379,080
Cost of goods sold
50,756
(797)
(2)
49,959
56,943
(919)
(2)
56,024
Research and development
169,509
(5,945)
(2)
163,564
111,542
(7,349)
(2)
104,193
Selling, general and administrative
221,407
(19,471)
(2) (3)
201,936
149,903
(31,667)
(2) (3)
118,236
Total costs and expenses
441,672
(26,213)
415,459
318,388
(39,935)
278,453
Operating income
199,650
26,213
225,863
60,692
39,935
100,627
Equity in losses of affiliated companies
2,232
(2,043)
(4)
189
4,466
(4,466)
(4)
-
Interest and other income (expense), net
41,774
4,865
(2) (5)
46,639
11,183
271
(5)
11,454
Income before taxes
239,192
33,121
272,313
67,409
44,672
112,081
Income tax provision (benefit)
126,913
(50,666)
(6)
76,247
41,777
(5,911)
(6)
35,866
Net income
$
112,279
$
83,787
196,066
$
25,632
$
50,583
$
76,215
Per common share:
Net income - basic
$
0.30
$
0.22
(7)
$
0.52
$
0.07
$
0.15
(7)
$
0.22
Net income - diluted
$
0.27
$
0.19
(7)
$
0.46
$
0.07
$
0.13
(7)
$
0.20
Weighted average shares outstanding-basic
379,350
379,350
345,841
345,841
Weighted average shares outstanding-diluted
430,346
430,346
369,108
402,129
Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings
(1)
Adjusted net income and adjusted per share amounts for the
six-month periods ended June 30, 2007 and 2006 eliminate the
effects of charges for share-based employee compensation expense
associated with the application of the Statement of Financial
Accounting Standards, or SFAS, No. 123 (revised 2004),
"Share-Based Payment", or SFAS 123(R). The after tax net impact of
share-based employee compensation expense reduced GAAP net income
by $20.5 million, or $0.05 per diluted share, for the six-month
period ended June 30, 2007 and $25.2 million, or $0.07 per diluted
share, for the six-month period ended June 30, 2006. Adjusted net
income and per share amounts for the six-month periods ended June
30, 2007 and 2006 also exclude amortization of acquisition
intangibles resulting from the acquisition of Penn T Limited,
charges to record our share of equity losses in EntreMed, Inc.,
charges recorded for changes in the estimated value of our
investment in EntreMed, Inc. warrants and adjustments to the
income tax provision to reflect an estimated pro-forma income tax
rate. Also, the six-month period ended June 30, 2006 excludes
accelerated depreciation expense related to the Company's
corporate headquarters relocation. See below for a description of
line item adjustments.
Line Item Adjustments:
(2)
To exclude SFAS 123(R) share-based compensation expense totaling
$26,554 and $35,500 for the six-month periods ended June 30, 2007
and 2006, respectively.
(3)
To exclude the amortization of acquisition intangibles resulting
from the acquisition of Penn T Limited in the amount of $4,465 in
2007 and $4,233 in 2006 and to exclude accelerated depreciation
expense related to the relocation of the Company's corporate
headquarters in the amount of $202 in 2006.
(4)
To exclude the Company's share of equity losses in EntreMed, Inc.
(5)
To exclude the charge recorded for changes in the estimated value of
the Company's investment in EntreMed, Inc. warrants.
(6)
The adjusted income tax provision reflects an annualized 28.0%
estimated pro-forma income tax rate for 2007 and a 32.0% estimated
pro-forma income tax rate for 2006. The tax rates for both years
was computed by taking the Company's GAAP earnings in each taxable
jurisdiction in which the Company operates and making adjustments
required to arrive at taxable income ("book-tax adjustments").
Taxable income is increased to add-back the tax deduction for the
exercise of employee stock options. In jurisdictions where net
operating losses are available for carry forward, taxable income
is reduced by the amount of net operating loss carry forwards that
the Company believes will be deductible and sustainable upon
audit. Taxable income, after the adjustments for employee stock
options and net operating loss carryforwards, is multiplied by the
applicable statutory tax rate to arrive at estimated taxes due.
Estimated taxes due are divided by the Company's adjusted income
before taxes to arrive at the pro-forma income tax rates.
(7)
Adjusted per share amounts represent adjusted net income divided by
the GAAP weighted average number of shares outstanding.
Celgene Corporation and Subsidiaries Consolidated Balance Sheet Data (Unaudited) (In thousands, except per share data)
June 30, December 31, 2007 2006
Cash, cash equivalents & marketable securities
$
2,321,812
$
1,982,220
Total assets
3,148,610
2,735,791
Convertible notes
399,880
399,889
Stockholders' equity
2,287,227
1,976,177
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