_ Record Fourth Quarter and Full Year Results Driven By Gains in Global Market Share, Duration of Therapy and Reimbursement Approvals î REVLIMID(R) Fourth Quarter Global Net Product Sales Increased Nearly 35% Y/Y î VIDAZA(R) Fourth Quarter Global Net Product Sales Increased Nearly 65% Y/Y î Full Year Non-GAAP Diluted Earnings Per Share Increased More Than 30 % Y/Y î Conducting 20 Phase III and Pivotal Clinical TrialsSUMMIT, N.J., Jan 11, 2010 (BUSINESS WIRE) -- Celgene Corporation (NASDAQ: CELG)
2009 Fourth Quarter Financial Results Year-Over-Year (Unaudited)
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Non-GAAP Total Revenue Increased More Than 20 Percent to Approximately
$755 Million
-
REVLIMID(R) Global Net Product Sales Increased Nearly 35
Percent to Approximately $495 Million
-
Global THALOMID(R)/Thalidomide Net Product Sales Reached
Approximately $105 Million
-
VIDAZA(R) Global Net Product Sales Increased Approximately 65
Percent to Approximately $115 Million
-
Non-GAAP Earnings Per Share Increased Nearly 45 Percent to
Approximately $0.62 Per Diluted Share
2009 Full Year Financial Results Year-Over-Year (Unaudited)
-
Non-GAAP Total Revenue Increased Approximately 20 Percent to
Approximately $2.67 Billion
-
REVLIMID(R) Global Net Product Sales Increased Nearly 30
Percent to Approximately $1.7 Billion
-
Global THALOMID(R)/Thalidomide Net Product Sales Reached
Approximately $435 Million
-
VIDAZA(R) Global Net Product Sales Increased to Approximately
$385 Million
-
Non-GAAP Diluted Earnings Per Share Increased More Than 30 Percent to
Approximately $2.08 Per Diluted Share
Celgene Forecasts Continued Revenue and Earnings Growth in 2010
-
Total Revenue Expected to Increase Approximately 20 Percent
Year-Over-Year to a Range of $3.2 to $3.3 Billion
-
REVLIMID Net Product Sales Anticipated to Increase Approximately 25
Percent Year-Over-Year to a Range of $2.1 to $2.2 Billion
-
Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately
25 Percent Year-Over-Year to a Range of $2.55 to $2.60
Celgene Strategically Positioned for Long-Term Global Growth
Hematology:
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More Than 200 Abstracts Evaluating Celgene Products Across a Range of
Indications Presented at the 51st American Society of Hematology
Meeting
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First Interim Analysis of Phase III MM-015 Study Reported 50 Percent
Improvement in Progression Free Survival in Newly Diagnosed Elderly
Multiple Myeloma Patients Receiving Continuous REVLIMID(R)
-
Initial Data from Cancer and Leukemia Group B (CALGB) Phase III Study
Reported Statistically Significant Improvement in Time-to-Disease
Progression with Continuous REVLIMID Therapy in Patients with Multiple
Myeloma Following Autologous Stem Cell Transplant
-
REVLIMID Regulatory and Reimbursement Approvals Granted in Multiple
Regions, Including U.K., Canada, Australia, and Latin America
-
New Drug Application Filed with Japanese Ministry of Health, Labor and
Welfare for REVLIMID in Previously Treated Multiple Myeloma and Del 5q
MDS
-
REVLIMID Compendia Listed and Added to National Cancer Comprehensive
Network (NCCN) Clinical Guidelines in Non-Hodgkin's Lymphoma as a
Second-Line Treatment Option for Mantle Cell Lymphoma
-
U.S. REVLIMID Label in Multiple Myeloma and Del 5q Myelodysplastic
Syndromes Updated With New Starting Dose Guidelines for Patients with
Renal Impairment
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VIDAZA(R) Launch Completed in Majority of Key European Regions
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VIDAZA Upgraded By NCCN to Preferred Therapy Based On Unprecedented
Survival for Intermediate-2 And High-Risk Myelodysplastic Syndromes
Oncology
-
Completed Enrollment of Amrubicin Phase III Trial In Patients With
Small Cell Lung Cancer; Data Expected in Mid-2010
-
Initiated Phase II Trial of ACE-011 for Treatment of Chemotherapy
Induced Anemia In Metastatic Breast Cancer
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Advanced REVLIMID Solid Tumor Program In Prostate Cancer, Renal Cell
Carcinoma, Pancreatic Cancer, and Colorectal Cancer
Inflammation and Immunology
-
Apremilast Phase II Study In Psoriatic Arthritis and Phase IIb Study
In Moderate-To-Severe Psoriasis Met Primary Endpoints; Phase III
Studies to Start in 2010
-
Completed Phase I Proof-Of-Principle Study For Proprietary PDA-001
Placenta-Derived Stem Cells In Crohn's Disease
-
Completed Phase Ib Multiple Dose Study of CC-930, a First-in-Class JNK
Inhibitor, in Healthy Volunteers Leading to Clinical Development
Programs in Serious Fibrotic Diseases
2009 Corporate Developments
-
Definitive Merger Agreement to Acquire Gloucester Pharmaceuticals
Providing Celgene With Novel HDAC Inhibitor, ISTODAX(R)
(romidepsin), for the Treatment of Cutaneous T-Cell Lymphoma; Received
Early Termination of the Hart-Scott-Rodino Waiting Period
-
Board of Directors Authorized the Repurchase of Up to $500 Million of
Common Stock Through April 2011
Celgene Corporation (NASDAQ: CELG) reviewed 2009 achievements and
provided an outlook for 2010 at the JPMorgan 28th Annual
Healthcare Conference. Preliminary 2009 unaudited results indicate that
non-GAAP total revenue will increase by approximately 20 percent to
approximately $2.67 billion. Non-GAAP diluted earnings per share are
expected to increase more than 30% to approximately $2.08. The Company
will report its 2009 full-year financial results on Thursday, January
28, 2010.
In 2010, total revenue is targeted to increase approximately 20 percent
year-over-year to a range of $3.2 to $3.3 billion, and non-GAAP diluted
earnings per share are targeted to increase approximately 25 percent to
a range of $2.55 to $2.60.
Non-GAAP Financial Information
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.
Webcast Information
A webcast of the Company's JPMorgan 28th Annual Healthcare
Conference presentation, scheduled for Monday, January 11, 2010 at 8
a.m. PT (11 a.m. ET), can be accessed by going to the Celgene website, www.celgene.com,
and clicking on "Investor Relations", and then "Webcast Event." This
event will be archived and accessible until 12 p.m. ET, January 18, 2010.
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 forward-looking statements which are subject to
known and unknown risks, delays, uncertainties and other factors not
under Celgene's control, which may cause actual results, performance or
achievements of Celgene to be materially different from the results,
performance or other expectations expressed or 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 other factors described in Celgene's
filings with the Securities and Exchange Commission such as its 10-K,
10-Q and 8-K reports.
SOURCE: Celgene Corporation
Celgene Corporation
David Gryska, 908-673-9059
Senior Vice President and Chief Financial Officer
or
Tim Smith, 908-673-9951
Director
Investor Relations
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