Celgene Corporation (NASDAQ: CELG):
2010 Second Quarter Financial Results
Year-Over-Year
-
Non-GAAP Total Revenue Increased 36 Percent to $850 Million; GAAP
Total Revenue $853 Million
-
Global REVLIMID Net Product Sales Increased 48 Percent to $587 Million
-
Global VIDAZA Net Product Sales Increased 43 Percent to $132 Million
-
Global THALOMID® Net Product Sales of $98 Million
-
Non-GAAP Operating Income Increased 55 Percent to $390 Million; GAAP
Operating Income $168 Million
-
Non-GAAP Net Income Increased 50 Percent to $323 Million; GAAP Net
Income $155 Million
-
Non-GAAP Diluted Earnings Per Share Increased 50 Percent to $0.69;
GAAP Diluted Earnings Per Share $0.33
2010 Financial Outlook Update
(excluding effects of the proposed acquisition of Abraxis BioScience,
unless noted)
-
Total Revenue Expected to Increase Approximately 28 Percent
Year-Over-Year to a Range of $3.40 to $3.45 Billion, Up From a
Previous Range of $3.3 to $3.4 Billion
-
REVLIMID Net Product Sales Anticipated to Increase Approximately 37
Percent Year-Over-Year to a Range of $2.30 to $2.35 Billion, Up From a
Previous Range of $2.2 to $2.3 Billion
-
Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately
30 Percent Year-Over-Year to a Range of $2.65 to $2.70 (Includes
Approximate $0.05 Dilution From Proposed Acquisition of Abraxis
BioScience), Up From a Previous Range of $2.60 to $2.65
Recent Developments and Highlights
-
Signed Definitive Merger Agreement to Acquire Abraxis BioScience
-
Successfully Implemented Senior Management Succession Plan: Dr. Sol J.
Barer Appointed Executive Chairman of the Board of Directors and
Robert J. Hugin Appointed Chief Executive Officer
-
REVLIMID® Granted Regulatory and Reimbursement Approval in
Japan for Use in Combination With Dexamethasone For Patients With
Relapsed or Refractory Multiple Myeloma Who Have Received at Least One
Prior Standard Therapy
-
More Than 100 Presentations and Posters Evaluating Celgene Products
Highlighted at American Society of Clinical Oncology (ASCO) Annual
Meeting, International Myeloma Working Group Summit, and European
Hematology Association Annual Meeting
-
Initiated PSA-002, a Phase III Trial Evaluating Apremilast in
Psoriatic Arthritis
-
Initiated DLC-001, a Phase II/III Study of REVLIMID in Patients With
Diffuse Large B-Cell Lymphoma
-
Completed U.S. Pivotal Study of ISTODAX® in Peripheral
T-Cell Lymphoma
-
Initiated Phase I Trial of TORKi (mTOR Kinase Inhibitor) CC-223
-
Initiated REN-001, a Phase II Trial Evaluating ACE-011 in Patients
With Renal Anemia
2010 Selected Corporate Objectives
-
Expand Celgene Product Approvals, Reimbursements and Global Market
Share
-
Submit REVLIMID Newly Diagnosed Multiple Myeloma (NDMM) Regulatory
Filings with European Medicines Agency
-
Launch REVLIMID in Japan for Multiple Myeloma
-
Complete Enrollment of MM-020, a Phase III Trial (n=1590) Evaluating
REVLIMID and Low-Dose Dexamethasone Versus Melphalan, Prednisone and
Thalidomide in NDMM
-
Submit ISTODAX Peripheral T-cell Lymphoma Regulatory Filing with Food
and Drug Administration
-
Advance More Than 20 Phase III and Pivotal Clinical Trials and 16
Preclinical Programs Addressing More Than 25 Serious and Debilitating
Diseases
-
Initiate Apremilast Phase III Studies in Moderate-To-Severe Psoriasis
and Phase II Study in Rheumatoid Arthritis
-
Initiate Pomalidomide Phase III Studies in Multiple Myeloma and
Myelofibrosis
-
Complete Amrubicin Phase III Trial in Patients With Small Cell Lung
Cancer
-
Initiate Multiple Phase II Trials for PDA-001 Cellular Therapy
-
Initiate Phase II Trial for JNK CC-930 in Idiopathic Pulmonary
Fibrosis and Discoid Lupus Erythematosus
Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally
Accepted Accounting Principles) net income of $323.3 million, or
non-GAAP diluted earnings per share of $0.69 for the quarter ended June
30, 2010. Non-GAAP net income for the second quarter of 2009 was $216.0
million or non-GAAP diluted earnings per share of $0.46. Based on U.S.
GAAP, Celgene reported net income of $155.4 million, or diluted earnings
per share of $0.33 for the quarter ended June 30, 2010. GAAP net income
for the second quarter of 2009 was $142.8 million, or diluted earnings
per share of $0.31.
Celgene posted non-GAAP net income of $617.8 million or non-GAAP diluted
earnings per share of $1.32 during the first six months of 2010 as
compared to non-GAAP net income of $421.2 million and non-GAAP diluted
earnings per share of $0.90 in 2009. On a GAAP basis, Celgene reported
net income of $389.8 million, or diluted earnings per share of $0.83 for
the first six months of 2010, compared to GAAP net income of $305.7
million, or diluted earnings per share of $0.65 in 2009.
“These outstanding results reflect the effectiveness of our operating
strategies and the exceptional execution of our global team,” said
Robert J. Hugin, Chief Executive Officer of Celgene Corporation. “Our
portfolio of products and promising hematology and immune-inflammatory
pipeline position us to make an increasingly meaningful impact on the
lives of patients suffering from serious unmet medical conditions. By
combining operational excellence with innovative science, we are
strategically positioned to produce sustained long-term growth.”
Product Sales Performance
Non-GAAP total revenue was a record $850.4 million for the quarter ended
June 30, 2010, an increase of 36 percent from 2009. GAAP total revenue
was $852.7 million for the quarter ended June 30, 2010. The increase in
total revenue was driven by global market share gains and increased
duration of therapy of REVLIMID. Net sales of REVLIMID were $587.1
million, an increase of 48 percent over the same period in 2009. Global
THALOMID® (inclusive of Thalidomide Celgene®
and Thalidomide Pharmion®) and VIDAZA® net sales
were $97.8 million and $131.8 million, respectively. Revenue from Focalin®
and the Ritalin® family of drugs totaled $27.0 million for
the second quarter of 2010 compared to $24.2 million over the same
period in 2009.
For the first six months of 2010, non-GAAP total revenue was a record $
1.639 billion, an increase of 34 percent year-over-year. GAAP total
revenue was $1.644 billion for the six months ended June 30, 2010.
REVLIMID net sales for the first six months of 2010 reached $1.118
billion, an increase of 47 percent over $759.8 million for the same
period in 2009. THALOMID net sales for the first six months of 2010 were
$201.8 million. Vidaza net sales for the first six months of 2010
reached $252.1 million, an increase of 51 percent over the same period
in 2009.
Research and Development
For the second quarter of 2010, non-GAAP R&D expenses, which exclude
upfront collaboration payments and share-based employee compensation
expense, were $201.6 million compared to $169.0 million for the second
quarter of 2009. These R&D expenditures continue to support ongoing
clinical progress in multiple proprietary development programs for
REVLIMID, pomalidomide and other IMiDs® compounds;
VIDAZA; ISTODAX®; amrubicin; apremilast and our oral
anti-inflammatory compounds; our kinase inhibitor programs; our activin
inhibitor program with ACE-011; and cellular therapy programs. On a GAAP
basis, R&D expenses were $342.8 million for the second quarter of 2010
and $218.5 million in the same period in 2009.
Selling, General, and Administrative
Non-GAAP selling, general and administrative expenses, which exclude
share-based employee compensation expense, were $197.1 million for the
second quarter of 2010 compared to $156.9 million for the second quarter
of 2009. The increase was primarily due to an increase in donations to
non-profit foundations, in addition to marketing and sales expenses
related to the continued expansion of our international commercial
activities. On a GAAP basis, selling, general and administrative
expenses were $219.3 million for the second quarter of 2010 and $176.3
million in the same period in 2009.
Interest and Other Income, Net
For the quarter ended June 30, 2010, interest and other income, net,
decreased to $4.6 million compared to $28.7 million in the same period
in 2009. The decrease was primarily due to a reduction in interest and
investment income as well as a loss on net hedging and foreign currency
revaluation in the quarter ended June 30, 2010, compared to a gain in
the same period in 2009.
Cash, Cash Equivalents, and Marketable Securities
Celgene reported $3.145 billion in cash, cash equivalents, and
marketable securities as of June 30, 2010.
Non-GAAP Financial Information
See the attached Reconciliation of GAAP to Non-GAAP Net Income for an
explanation of the amounts excluded and included to arrive at non-GAAP
net income and non-GAAP earnings per share amounts for the three-month
and six-month periods ended June 30, 2010 and 2009. See the attached
Reconciliation of Full-Year 2010 Projected GAAP to Non-GAAP Net Income
for an explanation of the amounts excluded and included to arrive at
projected non-GAAP net income and non-GAAP earnings per share amounts
for the year ending December 31, 2010. Non-GAAP financial measures
provide investors and management with supplemental measures of operating
performance and trends that facilitate comparisons between periods
before 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. Non-GAAP net income and
non-GAAP earnings per share are not, and should not be viewed as a
substitute for similar GAAP items. We define non-GAAP diluted earnings
per share amounts as non-GAAP net income divided by the weighted average
number of diluted shares outstanding. Our definition of non-GAAP net
income and non-GAAP diluted earnings per share may differ from similarly
named measures used by others.
Conference Call and Webcast Information
Celgene will host a conference call to discuss the results and
achievements of its second quarter 2010 and its operating and financial
performance on July 29, 2010, at 9 a.m. ET. The conference call will be
available by webcast at www.celgene.com.
An audio replay of the call will be available from noon July 29, 2010,
until midnight ET August 5, 2010. To access the replay, in the U.S. dial
800-642-1687; outside the U.S. dial 706-645-9291; and enter reservation
number 83920237. The Company’s third quarter 2010 financial and
operational results are expected to be reported in late October.
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 Web site 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. The Company’s actual results,
performance, or achievements could be materially different from those
projected by these forward-looking statements.The factors that
could cause actual results, performance, or achievements to differ from
the forward-looking statements are discussed in the Company’s filings
with the Securities and Exchange Commission, such as the Company’s Form
10-K, 10-Q and 8-K reports.Given these risks and uncertainties,
you are cautioned not to place undue reliance on the forward-looking
statements.
|
|
| Celgene Corporation and Subsidiaries |
| Condensed Consolidated Statements of Operations |
| (Unaudited) |
| (In thousands, except per share data) |
|
|
|
| |
| |
|
| |
| |
| | | | | | | | | | |
|
| | | | | | | | | | |
|
| | | |
Three Months Ended
| | |
Six Months Ended
|
| | | |
June 30,
| | |
June 30,
|
| | | |
2010
| |
2009
| | |
2010
| |
2009
|
| | | | | | | | | | |
|
|
Net product sales
| | | |
$
|
823,097
|
| |
$
|
598,154
| | | |
$
|
1,582,508
| | |
$
|
1,174,386
|
|
|
Collaborative agreements and other revenue
| | | | |
2,544
| | | |
2,354
| | | | |
4,924
| | | |
4,598
| |
|
Royalty revenue
| | | |
|
27,051
|
| |
|
28,158
|
| | |
|
56,514
|
| |
|
54,735
|
|
|
Total revenue
| | | |
|
852,692
|
| |
|
628,666
|
| | |
|
1,643,946
|
| |
|
1,233,719
|
|
| | | | | | | | | | |
|
Cost of goods sold (excluding amortization of acquired intangible
assets)
| | | | |
67,993
| | | |
50,902
| | | | |
129,908
| | | |
115,201
| |
|
Research and development
| | | | |
342,761
| | | |
218,500
| | | | |
547,418
| | | |
399,747
| |
|
Selling, general and administrative
| | | | |
219,262
| | | |
176,311
| | | | |
427,241
| | | |
349,752
| |
|
Amortization of acquired intangible assets
| | | | |
47,068
| | | |
22,667
| | | | |
88,661
| | | |
46,292
| |
|
Acquisition related charges
| | | |
|
7,836
|
| |
|
-
|
| | |
|
12,698
|
| |
|
-
|
|
|
Total costs and expenses
| | | |
|
684,920
|
| |
|
468,380
|
| | |
|
1,205,926
|
| |
|
910,992
|
|
| | | | | | | | | | |
|
|
Operating income
| | | | |
167,772
| | | |
160,286
| | | | |
438,020
| | | |
322,727
| |
| | | | | | | | | | |
|
|
Equity in (gains) losses of affiliated companies
| | | | |
103
| | | |
(157
|
)
| | | |
(638
|
)
| | |
615
| |
|
Interest and other income, net
| | | |
|
4,610
|
| |
|
28,721
|
| | |
|
21,979
|
| |
|
78,320
|
|
| | | | | | | | | | |
|
|
Income before income taxes
| | | | |
172,279
| | | |
189,164
| | | | |
460,637
| | | |
400,432
| |
| | | | | | | | | | |
|
|
Income tax provision
| | | |
|
16,927
|
| |
|
46,329
|
| | |
|
70,843
|
| |
|
94,715
|
|
| | | | | | | | | | |
|
|
Net income
| | | |
$
|
155,352
|
| |
$
|
142,835
|
| | |
$
|
389,794
|
| |
$
|
305,717
|
|
| | | | | | | | | | |
|
|
Net income per common share:
| | | | | | | | | | | |
|
Basic
| | | |
$
|
0.34
| | |
$
|
0.31
| | | |
$
|
0.85
| | |
$
|
0.67
| |
|
Diluted
| | | |
$
|
0.33
| | |
$
|
0.31
| | | |
$
|
0.83
| | |
$
|
0.65
| |
| | | | | | | | | | |
|
|
Weighted average shares - basic
| | | |
|
460,309
|
| |
|
459,586
|
| | |
|
460,112
|
| |
|
459,584
|
|
| | | | | | | | | | |
|
|
Weighted average shares - diluted
| | | |
|
467,425
|
| |
|
467,082
|
| | |
|
467,557
|
| |
|
467,759
|
|
| | | | | | | | | | |
|
| | | | | | | | | | |
|
| | | |
June 30,
| |
December 31,
| | | | | |
| | | |
2010
| |
2009
| | | | | |
| Balance sheet items: | | | | | | | | | | | |
|
Cash, cash equivalents & marketable securities
| | | |
$
|
3,144,617
| | |
$
|
2,996,752
| | | | | | |
|
Total assets
| | | | |
6,178,238
| | | |
5,389,311
| | | | | | |
|
Stockholders' equity
| | | | |
4,927,810
| | | |
4,394,606
| | | | | | |
| | | | | | | | | | | | | | |
|
|
|
| Celgene Corporation and Subsidiaries |
| Reconciliation of GAAP to Non-GAAP Net Income |
| (In thousands, except per share data) |
|
| |
| |
| |
|
| |
| |
| | | | | | | | | | |
|
| | | |
Three Months Ended
| | |
Six Months Ended
|
| | | |
June 30,
| | |
June 30,
|
| | | |
2010
| |
2009
| | |
2010
| |
2009
|
| | | | | | | | | | |
|
|
Net income - GAAP
| | | |
$
|
155,352
| | |
$
|
142,835
| | | |
$
|
389,794
| | |
$
|
305,717
| |
| | | | | | | | | | |
|
|
Before tax adjustments:
| | | | | | | | | | | |
|
Net product sales:
| | | | | | | | | | | |
|
Pharmion products to be divested
| |
(1)
| | |
(2,301
|
)
| | |
(2,515
|
)
| | | |
(4,675
|
)
| | |
(6,466
|
)
|
| | | | | | | | | | |
|
Cost of goods sold (excluding amortization of acquired intangible
assets):
| | | | | | | | | | | |
|
Share-based compensation expense
| |
(2)
| | |
1,602
| | | |
1,001
| | | | |
3,121
| | | |
1,973
| |
|
Pharmion inventory step-up
| |
(3)
| | |
-
| | | |
-
| | | | |
-
| | | |
354
| |
|
Pharmion products to be divested
| |
(1)
| | |
4,397
| | | |
2,000
| | | | |
8,683
| | | |
4,268
| |
| | | | | | | | | | |
|
|
Research and development:
| | | | | | | | | | | |
|
Share-based compensation expense
| |
(2)
| | |
20,023
| | | |
14,965
| | | | |
39,153
| | | |
29,663
| |
|
Upfront collaboration payments
| |
(4)
| | |
121,176
| | | |
34,500
| | | | |
121,176
| | | |
34,500
| |
| | | | | | | | | | |
|
|
Selling, general and administrative:
| | | | | | | | | | | |
|
Share-based compensation expense
| |
(2)
| | |
22,185
| | | |
19,363
| | | | |
42,116
| | | |
36,217
| |
| | | | | | | | | | |
|
|
Amortization of acquired intangible assets:
| | | | | | | | | | | |
|
Pharmion
| |
(5)
| | |
39,991
| | | |
22,667
| | | | |
79,928
| | | |
46,292
| |
|
Gloucester
| |
(5)
| | |
7,077
| | | |
-
| | | | |
8,733
| | | |
-
| |
| | | | | | | | | | |
|
|
Acquisition related charges
| | | | | | | | | | | |
|
Gloucester contingent liability accretion
| |
(6)
| | |
5,892
| | | |
-
| | | | |
10,754
| | | |
-
| |
|
Abraxis acquisition costs
| |
(6)
| | |
1,944
| | | |
-
| | | | |
1,944
| | | |
-
| |
| | | | | | | | | | |
|
|
Equity in losses of affiliated companies - EntreMed
| |
(7)
| | |
56
| | | |
321
| | | | |
442
| | | |
659
| |
| | | | | | | | | | |
|
|
Net income tax adjustments
| |
(8)
| |
|
(54,130
|
)
| |
|
(19,112
|
)
| | |
|
(83,344
|
)
| |
|
(32,004
|
)
|
Net income - non-GAAP
| | | |
$
|
323,264
|
| |
$
|
216,025
|
| | |
$
|
617,825
|
| |
$
|
421,173
|
|
| | | | | | | | | | |
|
Net income per common share - non-GAAP:
| | | | | | | | | | | |
|
Basic
| | | |
$
|
0.70
| | |
$
|
0.47
| | | |
$
|
1.34
| | |
$
|
0.92
| |
|
Diluted
| | | |
$
|
0.69
| | |
$
|
0.46
| | | |
$
|
1.32
| | |
$
|
0.90
| |
|
Explanation of adjustments:
|
|
(1)
|
Exclude sales and costs related to former non-core Pharmion Corp.,
or Pharmion, products to be divested.
|
|
(2)
|
Exclude share-based compensation expense for the second quarter
totaling $43,810 in 2010 and $35,329 in 2009. The after tax net
impact reduced GAAP net income for the second quarter by $33,850,
or $0.07 per diluted share in 2010 and $27,315, or $0.06 per
diluted share in 2009. Exclude share-based compensation expense
for the six-month period totaling $84,390 in 2010 and $67,853 in
2009. The after tax net impact reduced GAAP net income for the
six-month period by $65,223, or $0.14 per diluted share in 2010
and $52,462, or $0.11 per diluted share in 2009.
|
|
(3)
|
Exclude acquisition-related Pharmion inventory step-up adjustment to
fair value expensed during the period.
|
|
(4)
|
Exclude upfront payments for research and development
collaboration arrangements with Agios Pharmaceuticals, Inc. for
both the three-month and six-month periods in 2010 and
GlobeImmune, Inc. and Array BioPharma Inc. of $30,000 and $4,500,
respectively for both the three-month and six-month periods in
2009.
|
|
(5)
|
Exclude amortization of acquired intangible assets from the
acquisitions of Pharmion and Gloucester Pharmaceuticals, Inc., or
Gloucester.
|
|
(6)
|
Exclude acquisition related charges for Gloucester and the proposed
acquisition of Abraxis BioScience, Inc.
|
|
(7)
|
Exclude the Company's share of equity losses in EntreMed, Inc.
|
|
(8)
|
Net income tax adjustments reflects the estimated tax effect of the
above adjustments.
|
|
|
|
|
| Celgene Corporation and Subsidiaries |
| Reconciliation of Full-Year 2010 Projected GAAP to Non-GAAP Net
Income |
| (In thousands, except per share data) |
|
|
|
| |
|
| |
| | | | | | |
|
| | | |
Range
|
| | | |
Low
| | |
High
|
| | | | | | |
|
|
Projected net income - GAAP
| | | |
$
|
805,000
| | | |
$
|
859,000
| |
| | | | | | |
|
|
Before tax adjustments:
| | | | | | | |
| | | | | | |
|
|
Share-based compensation expense
| | | | |
180,000
| | | | |
175,000
| |
| | | | | | |
|
|
Amortization of acquired intangible assets:
| | | | | | | |
|
Pharmion
| | | | |
160,000
| | | | |
160,000
| |
|
Gloucester
| | | | |
22,000
| | | | |
22,000
| |
|
Abraxis
| | | | |
30,000
| | | | |
20,000
| |
| | | | | | |
|
|
Upfront collaboration payments
| | | | |
121,000
| | | | |
121,000
| |
| | | | | | |
|
|
Acquisition related charges
| | | | | | | |
|
Gloucester
| | | | |
23,000
| | | | |
23,000
| |
|
Abraxis
| | | | |
50,000
| | | | |
30,000
| |
| | | | | | |
|
|
Pharmion products to be divested
| | | | |
4,000
| | | | |
4,000
| |
| | | | | | |
|
|
Net income tax adjustments
| | | |
|
(147,000
|
)
| | |
|
(142,000
|
)
|
|
Projected net income - non-GAAP
| | | |
$
|
1,248,000
|
| | |
$
|
1,272,000
|
|
| | | | | | |
|
|
Projected net income per diluted common share - GAAP
| | | |
$
|
1.71
| | | |
$
|
1.82
| |
| | | | | | |
|
|
Projected net income per diluted common share - non-GAAP
| | | |
$
|
2.65
| | | |
$
|
2.70
| |
| | | | | | |
|
|
Projected weighted average diluted shares
| | | |
|
471,000
|
| | |
|
471,000
|
|
