Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - CELGENE CORP /DE/ | c10767e8vk.htm |
Exhibit 99.1
Contact: |
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| Jacqualyn A. Fouse | Tim Smith | |||
| Sr. Vice President and | Director | |||
| Chief Financial Officer | Investor Relations | |||
| Celgene Corporation | Celgene Corporation | |||
| (908) 673-9956 | (908) 673-9951 |
CELGENE CORPORATION REVIEWS 2010 ACHIEVEMENTS AND ANNOUNCES 2011 FINANCIAL OUTLOOK
Record Results Driven By Gains in Market Share and Duration of Therapy, Geographic Expansion and Reimbursement Approvals
Non-GAAP Total Revenue Increased Approximately 34 Percent Y/Y
Non-GAAP Diluted Earnings Per Share Increased Nearly 35 Percent Y/Y
Board of Directors Authorized the Repurchase of Up to An Additional $500 Million of the Company’s Common Stock
2010 Fourth Quarter Financial Results Year-Over-Year (Unaudited)
| • | Non-GAAP Total Revenue Increased Approximately 38 Percent to Approximately $1.05 Billion;
GAAP Total Revenue Approximately $1.06 Billion |
|
| • | Global REVLIMID Net Product Sales Increased Approximately 42 Percent to Approximately $708
Million |
|
| • | Global VIDAZA® Net Product Sales Increased Nearly 20 Percent to Approximately
$140 Million |
|
| • | Global THALOMID® Net Product Sales of Approximately $91 Million |
|
| • | ABRAXANE® Net Product Sales of Approximately $71 Million (Since October 15, 2010
Closing of Abraxis BioScience Acquisition) |
|
| • | Non-GAAP Diluted Earnings Per Share Increased Nearly 18 Percent to Approximately $0.73;
GAAP Diluted Earnings Per Share Approximately $0.41 (Includes Impact of Acquisition of Abraxis
BioScience) |
2010 Full Year Financial Results Year-Over-Year (Unaudited)
| • | Non-GAAP Total Revenue Increased Approximately 34 Percent to Approximately $3.60 Billion;
GAAP Total Revenue Approximately $3.62 Billion |
|
| • | Global REVLIMID® Net Product Sales Increased Approximately 44 Percent to Approximately $2.47
Billion |
|
| • | Global VIDAZA Net Product Sales Increased Approximately 38 Percent to
Approximately $534 Million |
|
| • | Global THALOMID® Net Product Sales of Approximately $387 Million |
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| • | Non-GAAP Diluted Earnings Per Share Increased Nearly 35 Percent to Approximately $2.80;
GAAP Diluted Earnings Per Share Approximately $1.85 (Includes Impact of Acquisition of Abraxis
BioScience) |
Celgene Forecasts Continued Revenue and Earnings Growth in 2011
| • | Non-GAAP Total Revenue Expected to Increase Approximately 25 Percent Year-Over-Year to a
Range of $4.4 to $4.5 Billion |
|
| • | REVLIMID® Net Product Sales Anticipated to Increase Approximately 25 Percent
Year-Over-Year to a Range of $3.0 to $3.1 Billion |
|
| • | Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 20 Percent
Year-Over-Year to a Range of $3.30 to $3.35 (Includes Impact of Acquisition of Abraxis
BioScience) |
2010 Milestones and Accomplishments
Hematology
| • | REVLIMID® Marketing Authorization Application Submitted to European Medicines Agency for
Newly Diagnosed Multiple Myeloma (NDMM) and Maintenance Therapy |
|
| • | Completed Enrollment of MM-020, Phase III Trial (n=1600) Evaluating REVLIMID and Low-Dose
Dexamethasone Versus Melphalan, Prednisone, and Thalidomide in NDMM |
|
| • | Initiated Launch of REVLIMID in Japan as a Treatment for Patients with Relapsed/Refractory
Multiple Myeloma (R/R MM) and del(5q) Myelodysplastic Syndromes (MDS) |
|
| • | Reported Significant Improvement in Survival and Risk Reduction in Disease Progression for
Patients With del(5q) MDS in REVLIMID MDS-004 Trial |
|
| • | Initiated DLC-001, a Phase II/III Study of REVLIMID in Patients With Relapsed/Refractory
Diffuse Large B-Cell Lymphoma |
|
| • | Initiated MDS-005, a Phase III Trial Evaluating REVLIMID in Low/Int-1 Non-del(5q) MDS |
|
| • | ISTODAX® Supplemental New Drug Application Filed with U.S. Food and Drug
Administration (FDA) for Relapsed/Refractory Peripheral T-Cell Lymphoma |
|
| • | Initiated AZA-AML-001, a Phase III Trial Evaluating VIDAZA® in Newly Diagnosed
Acute Myeloid Leukemia |
Oncology
| • | ABRAXANE® Pharmaceutical Composition and Method Claims Patent Issued on October 26, 2010,
Expiring in 2024 |
|
| • | Completed Interim Analysis
of ABRAXANE Phase III Study in Non-Small Cell Lung
Cancer (NSCLC); Interim Analysis of Progression Free Survival (PFS) in the Intent-to-Treat
Population, While Not Statistically Significant, Supports Submission of a Supplemental New
Drug Application for the Treatment of Advanced NSCLC During the Second Half of 2011. Final
Analysis, Including Subset Analyses, Expected to Be Completed and Presented During an Upcoming
Medical Meeting |
|
| • | Pivotal ABRAXANE Phase III Trial in Pancreatic Cancer Rapidly Enrolling; Increased Target
Enrollment From 630 Patients to 840 Patients, Increasing Power of Study to 90 Percent From 80
Percent |
|
| • | Advanced Phase III Trial of ABRAXANE in Melanoma; Advanced Phase II Trials in Bladder and
Ovarian Cancer |
|
| • | Formed Strategic Research Collaboration With Agios Pharmaceuticals, Focused on Targeting
Cancer Metabolism |
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Inflammation and Immunology
| • | Initiated PALACE 1, PALACE 2, PALACE 3, and PALACE 4, Phase III Trials Evaluating
Apremilast in Psoriatic Arthritis (n=2,000), and ESTEEM 1 and ESTEEM 2, Phase III Trials
Evaluating Apremilast in Moderate-to-Severe Psoriasis (n=1,200) |
|
| • | Initiated MF-002, a Phase III Trial Evaluating Pomalidomide in Myelofibrosis |
|
| • | Initiated Phase I/II Trials for PDA-001 Cellular Therapy in Crohn’s Disease, Multiple
Sclerosis, and Rheumatoid Arthritis |
|
| • | Initiated REN-001, a Phase II Trial Evaluating ACE-011 in Patients With Renal Anemia |
|
| • | Initiated Phase I Trial of TORKi (mTOR Kinase Inhibitor) CC-223 |
SUMMIT, NJ — (January 10, 2011) — Celgene Corporation (NASDAQ: CELG) today reviewed 2010
achievements and provided an outlook for 2011 at the JPMorgan 29th Annual Healthcare
Conference. Preliminary 2010 unaudited results indicate that non-GAAP total revenue will increase
by approximately 34 percent to approximately $3.60 billion. Non-GAAP diluted earnings per share are
expected to increase nearly 35 percent to approximately $2.80. The Company will report its 2010
full-year financial results on Thursday, January 27, 2011.
In 2011, non-GAAP total revenue is targeted to increase approximately 25 percent year-over-year to
a range of $4.4 to $4.5 billion, and non-GAAP diluted earnings per share are targeted to increase
approximately 20 percent to a range of $3.30 to $3.35.
Non-GAAP Financial Information
See the attached Reconciliation of projected GAAP to Non-GAAP total revenue and earnings per share for an explanation of the amounts excluded and included to arrive at non-GAAP total revenue and non-GAAP earnings per share amounts for the three-month and twelve-month periods ended December 31, 2010 and for the twelve-month period ending December 31, 2011. 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 total revenue 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 total revenue and non-GAAP diluted earnings per share may differ from similarly named measures used by others.
See the attached Reconciliation of projected GAAP to Non-GAAP total revenue and earnings per share for an explanation of the amounts excluded and included to arrive at non-GAAP total revenue and non-GAAP earnings per share amounts for the three-month and twelve-month periods ended December 31, 2010 and for the twelve-month period ending December 31, 2011. 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 total revenue 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 total revenue and non-GAAP diluted earnings per share may differ from similarly named measures used by others.
Webcast Information
Celgene will host a conference call to discuss the results and achievements of its fourth quarter and full year 2010 operating and financial performance on January 27, 2011, 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 ET January 27, 2011, until midnight ET February 3, 2011. To access the replay, in the U.S. dial 800-642-1687; outside the U.S. dial 706-645-9291; and enter reservation number 35819129.
Celgene will host a conference call to discuss the results and achievements of its fourth quarter and full year 2010 operating and financial performance on January 27, 2011, 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 ET January 27, 2011, until midnight ET February 3, 2011. To access the replay, in the U.S. dial 800-642-1687; outside the U.S. dial 706-645-9291; and enter reservation number 35819129.
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.
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.
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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.
# # #
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Celgene Corporation and Subsidiaries
Reconciliation of Projected GAAP to Non-GAAP Total Revenue and Diluted Earnings Per Share
(In thousands, except per share data)
(Unaudited)
Reconciliation of Projected GAAP to Non-GAAP Total Revenue and Diluted Earnings Per Share
(In thousands, except per share data)
(Unaudited)
| Three Months Ended | ||||||||||||
| December 31, 2010 | ||||||||||||
| Range | ||||||||||||
| Low | High | |||||||||||
Total Revenue — GAAP |
$ | 1,062,000 | $ | 1,066,000 | ||||||||
Less sales of products to be divested |
17,000 | 19,000 | ||||||||||
| Total Revenue — Non-GAAP | Approximately $1.05 Billion |
|||||||||||
Projected diluted earnings per common share — GAAP |
$ | 0.40 | $ | 0.42 | ||||||||
Per share impact of excluded items before tax: |
||||||||||||
Sales of products to be divested |
(1 | ) | (0.04 | ) | (0.04 | ) | ||||||
Share-based compensation expense |
(2 | ) | 0.10 | 0.10 | ||||||||
Amortization of acquired intangible assets |
(4 | ) | 0.15 | 0.14 | ||||||||
Acquisition related charges |
(5 | ) | 0.10 | 0.09 | ||||||||
Abraxis inventory step-up |
(6 | ) | 0.06 | 0.05 | ||||||||
Change in value of Contingent Value Rights |
(7 | ) | (0.03 | ) | (0.03 | ) | ||||||
Non-core activities |
(8 | ) | 0.08 | 0.08 | ||||||||
Net income tax adjustments |
(9 | ) | (0.09 | ) | (0.08 | ) | ||||||
| Projected diluted earnings per common share — non-GAAP | Approximately $0.73 |
|||||||||||
| Twelve Months Ended | ||||||||||||
| December 31, 2010 | ||||||||||||
| Range | ||||||||||||
| Low | High | |||||||||||
Total Revenue — GAAP |
$ | 3,616,000 | $ | 3,620,000 | ||||||||
Less sales of products to be divested |
23,000 | 25,000 | ||||||||||
| Total Revenue — Non-GAAP | Approximately $3.60 Billion |
|||||||||||
Projected diluted earnings per common share — GAAP |
$ | 1.84 | $ | 1.86 | ||||||||
Per share impact of excluded items before tax: |
||||||||||||
Sales of products to be divested |
(1 | ) | (0.05 | ) | (0.05 | ) | ||||||
Share-based compensation expense |
(2 | ) | 0.38 | 0.38 | ||||||||
Upfront collaboration payments |
(3 | ) | 0.26 | 0.26 | ||||||||
Amortization of acquired intangible assets |
(4 | ) | 0.44 | 0.43 | ||||||||
Acquisition related charges |
(5 | ) | 0.14 | 0.13 | ||||||||
Abraxis inventory step-up |
(6 | ) | 0.06 | 0.05 | ||||||||
Change in value of Contingent Value Rights |
(7 | ) | (0.03 | ) | (0.03 | ) | ||||||
Non-core activities |
(8 | ) | 0.10 | 0.10 | ||||||||
Net income tax adjustments |
(9 | ) | (0.34 | ) | (0.33 | ) | ||||||
| Projected diluted earnings per common share — non-GAAP | Approximately $2.80 |
|||||||||||
Celgene Corporation and Subsidiaries
Reconciliation of Projected GAAP to Non-GAAP Total Revenue and Diluted Earnings Per Share
(In thousands, except per share data)
(Unaudited)
Reconciliation of Projected GAAP to Non-GAAP Total Revenue and Diluted Earnings Per Share
(In thousands, except per share data)
(Unaudited)
| Twelve Months Ending | ||||||||||||
| December 31, 2011 | ||||||||||||
| Range | ||||||||||||
| Low | High | |||||||||||
Total Revenue — GAAP |
$ | 4,422,000 | $ | 4,557,000 | ||||||||
Less sales of products to be divested |
22,000 | 57,000 | ||||||||||
Total Revenue — Non-GAAP |
$ | 4,400,000 | $ | 4,500,000 | ||||||||
Projected diluted earnings per common share — GAAP |
$ | 2.33 | $ | 2.54 | ||||||||
Per share impact of excluded items before tax: |
||||||||||||
Sales of products to be divested |
(1 | ) | (0.05 | ) | (0.12 | ) | ||||||
Share-based compensation expense |
(2 | ) | 0.42 | 0.40 | ||||||||
Amortization of acquired intangible assets |
(4 | ) | 0.57 | 0.55 | ||||||||
Acquisition related charges |
(5 | ) | 0.03 | 0.02 | ||||||||
Abraxis inventory step-up |
(6 | ) | 0.12 | 0.12 | ||||||||
Non-core activities |
(8 | ) | 0.25 | 0.17 | ||||||||
Net income tax adjustments |
(9 | ) | (0.37 | ) | (0.33 | ) | ||||||
Projected diluted earnings per common share — non-GAAP |
$ | 3.30 | $ | 3.35 | ||||||||
Explanation of adjustments:
| (1) | Exclude sales related to non-core former Pharmion Corp., or Pharmion, and Abraxis Bioscience Inc., or Abraxis, products to be divested. |
|
| (2) | Exclude employee share-based compensation expense. |
|
| (3) | Exclude upfront payments for research and development collaboration arrangements. |
|
| (4) | Exclude amortization of acquired intangible assets from the acquisitions of Abraxis, Pharmion and Gloucester Pharmaceuticals, Inc., or Gloucester. |
|
| (5) | Exclude deal related acquisition costs and restructuring costs for Gloucester and Abraxis and Gloucester contingent liability accretion. |
|
| (6) | Exclude acquisition-related Abraxis inventory step-up adjustment to fair value expensed during the period. |
|
| (7) | Exclude the change in fair value of the Company’s liability related to publicly traded contingent value rights that were issued as part of the
acquisition of Abraxis. |
|
| (8) | Exclude the estimated impact of activities arising from the acquisitions of Abraxis that are not related to core nab technology and
of Pharmion that are planned to be divested, including the cost of goods sold for products to be divested as well as operating
expenses related to such activities. |
|
| (9) | Net income tax adjustments reflects the estimated tax effect of the above adjustments. |