Attached files
file | filename |
---|---|
8-K - 8-K - CELGENE CORP /DE/ | c95070e8vk.htm |
Exhibit 99.1
Contact: |
||||
David Gryska | Tim Smith | |||
Sr. Vice President and | Director | |||
Chief Financial Officer | Investor Relations | |||
Celgene Corporation | Celgene Corporation | |||
(908) 673-9059 | (908) 673-9951 |
CELGENE REPORTS RECORD FOURTH QUARTER AND FULL YEAR
2009 PRODUCT SALES AND OPERATING INCOME
2009 PRODUCT SALES AND OPERATING INCOME
| Record Fourth Quarter and Full Year Results Driven By Gains in Global Market Share, Duration of Therapy and
Reimbursement Approvals |
|
| REVLIMID® Fourth Quarter Global Net Product Sales Increased 35% Y/Y and 11% Q/Q |
|
| VIDAZA® Fourth Quarter Global Net Product Sales Increased 68% Y/Y and 13% Q/Q |
|
| Full Year Non-GAAP Diluted Earnings Per Share Increased 33% Y/Y |
2009 Fourth Quarter Financial Results Year-Over-Year:
| Non-GAAP Total Revenue Increased 22 Percent to $758 Million; GAAP Total Revenue $761
Million |
|
| Global REVLIMID Net Product Sales Increased 35 Percent to $497 Million |
|
| Global VIDAZA Net Product Sales Increased 68 Percent to $117 Million |
|
| Global THALOMID® Net Product Sales of $108 Million |
|
| Non-GAAP Operating Income Increased 48 Percent to $337 Million; GAAP Operating Income $283
Million |
|
| Non-GAAP Net Income Increased to $290 Million; GAAP Net Income $254 Million |
|
| Non-GAAP Diluted Earnings Per Share Increased to $0.62; GAAP Diluted Earnings Per Share
$0.54 |
2009 Full Year Financial Results Year-Over-Year:
| Non-GAAP Total Revenue Increased 20 Percent to $2.68 Billion; GAAP Total Revenue $2.69
Billion |
|
| Global REVLIMID Net Product Sales Increased 29 Percent to $1.71 Billion |
|
| Global VIDAZA Net Product Sales Increased to $387 Million |
|
| Global THALOMID Net Product Sales of $437 Million |
|
| Non-GAAP Operating Income Increased 30 Percent to $1.10 Billion; GAAP Operating Income $842
Million |
|
| Non-GAAP Net Income Increased to $971 Million; GAAP Net Income $777 Million |
|
| Non-GAAP Diluted Earnings Per Share Increased 33 Percent to $2.08; GAAP Diluted Earnings Per Share
$1.66 |
1
2010 Financial Outlook Year-Over-Year
| Total Revenue Expected to Increase Approximately 20 Percent to a Range of $3.2 to $3.3
Billion |
|
| REVLIMID® Net Product Sales Anticipated to Increase Approximately 25 Percent to
a Range of $2.1 to $2.2 Billion |
|
| Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 25 Percent to a
Range of $2.55 to $2.60 |
Recent Developments and Highlights
Hematology
Hematology
| More Than 200 Abstracts Evaluating Celgene Products Across a Range of Indications Presented
at the 51st American Society of Hematology Meeting |
|
| 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 |
|
| Initial Data from National Cancer Institute (NCI) and 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 |
|
| Initial Data from Intergroupe Francophone du Myelome (IFM) Phase III Study Reported
Statistically Significant Improvement in Progression Free Survival 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 Myelodysplastic Syndrome |
|
| U.S. REVLIMID Label in Multiple Myeloma and Del 5q Myelodysplastic Syndrome Updated With
New Starting Dose Guidelines for Patients with Renal Impairment |
|
| VIDAZA® Launch Completed in Majority of Key European Regions |
Oncology
| Completed Enrollment of Amrubicin Phase III Trial In Patients With Small Cell Lung Cancer;
Data Expected in Second Half of 2010 |
|
| Initiated Phase II Trial of ACE-011 for Treatment of Chemotherapy Induced Anemia In
Metastatic Breast Cancer |
|
| 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 Crohns Disease |
|
| Completed Phase Ib Multiple Dose Study of CC-930, a First-in-Class JNK Inhibitor |
2
Selected Corporate Developments
| Acquired Gloucester Pharmaceuticals, Providing Celgene With Novel HDAC Inhibitor,
ISTODAX® (romidepsin), for the Treatment of Cutaneous T-Cell Lymphoma (CTCL) |
|
| R&D Day Scheduled for March 4, 2010 |
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 and Food and Drug Administration |
|
| Gain Marketing Approval and 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 |
|
| REVLIMID Data from IFM 2005-02, CALGB-100104, and MM-015 Trials to be Presented at Major
Medical Meetings |
|
| Complete Launch of VIDAZA® in Europe and Rest-of-World |
|
| Launch ISTODAX in CTCL in the U.S. and Complete U.S. Pivotal Study in Peripheral T-Cell
Lymphoma |
|
| Advance 20 Phase III and Pivotal Clinical Trials |
|
| Advance 16 Preclinical Programs Addressing More Than 25 Serious and Debilitating Diseases |
|
| Initiate Apremilast Phase III Studies in Psoriasis and Psoriatic Arthritis |
|
| Initiate Pomalidomide Pivotal 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 Trials for JNK CC-930 in Idiopathic Pulmonary Fibrosis |
SUMMIT, NJ (January 28, 2010) Celgene Corporation (NASDAQ: CELG) announced non-GAAP
(Generally Accepted Accounting Principles) net income of $290.3 million, or non-GAAP diluted
earnings per share of $0.62 for the quarter ended December 31, 2009. Non-GAAP net income for the
fourth quarter of 2008 was $200.9 million or non-GAAP diluted earnings per share of $0.43. Based
on U.S. GAAP, Celgene reported net income of $254.2 million, or diluted earnings per share of $0.54
for the quarter ended December 31, 2009. GAAP net loss for the fourth quarter of 2008 was $149.3
million, or diluted loss per share of $0.33.
Celgene posted non-GAAP net income of $971.3 million or non-GAAP diluted earnings per share of
$2.08 during 2009 as compared to non-GAAP net income of $718.8 million and non-GAAP diluted
earnings per share of $1.56 in 2008. On a GAAP basis, Celgene reported net income of $776.7 million
or diluted earnings per share of $1.66 for 2009, compared to GAAP net loss of $1.534 billion or a
diluted loss per share of $3.46 in 2008, which was primarily due to an in-process research and
development charge associated with the acquisition of Pharmion Corporation in March 2008.
3
Product Sales Performance
Non-GAAP total revenue was a record $757.8 million for the quarter ended December 31, 2009, an
increase of 22 percent from 2008. GAAP total revenue was $761.0 million for the quarter ended
December 31, 2009. The increase in total revenue was driven by global market share gains, increased
duration of therapy of REVLIMID® and reimbursement approvals. Net sales of REVLIMID
were $497.1 million, an increase of 35 percent over the same period in 2008. Global
THALOMID® (inclusive of Thalidomide Celgene and Thalidomide Pharmion) and
VIDAZA® net sales were $107.7 million and $116.7 million, respectively. Revenue from
Focalin® and the Ritalin® family of drugs totaled $27.6 million for the
fourth quarter of 2009 compared to $27.9 million over the same period in 2008.
For the full year of 2009, non-GAAP total revenue was a record $2.677 billion, an increase of 20
percent year-over-year. GAAP total revenue was $2.690 billion for 2009. Total non-GAAP net product
sales reached a record $2.555 billion, an increase of 21 percent year-over-year. REVLIMID net sales
for the full year reached $1.706 billion compared to $1.325 billion in 2008. Global 2009 THALOMID
and VIDAZA net sales for the full year were $436.9 million and $387.2 million, respectively.
Research and Development
For the fourth quarter of 2009, non-GAAP R&D expenses, which exclude share-based employee
compensation expense, were $181.8 million compared to $153.8 million for the fourth quarter of
2008, which also excluded the purchase of the VIDAZA royalty obligation. These R&D expenditures
continue to support ongoing clinical progress in multiple proprietary development programs for
REVLIMID, pomalidomide and other IMiDs® compounds; VIDAZA; amrubicin, our lead compound
for small cell lung cancer; 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 $201.7 million for the fourth quarter of 2009 and $468.6 million in
the same period in 2008.
Selling, General, and Administrative
Non-GAAP selling, general and administrative expenses, which exclude share-based employee
compensation expense, were $193.3 million for the fourth quarter of 2009 compared to $181.7 million
for the fourth quarter of 2008. The increase was primarily due to marketing and sales expenses
related to product launch activities of VIDAZA in Europe. On a GAAP basis, selling, general and
administrative expenses were $211.6 million for the fourth quarter of 2009 and $200.2 million in
the same period in 2008.
Interest and Other Income, Net
For the quarter ended December 31, 2009, interest and other income, net, decreased to $22.0 million
compared to $34.9 million in the same period in 2008.
Cash, Cash Equivalents, and Marketable Securities
Celgene reported $2.997 billion in cash, cash equivalents, and marketable securities as of December
31, 2009, an increase of $774.7 million from December 31, 2008.
4
Non-GAAP Financial Information
See the attached Reconciliation of GAAP to Non-GAAP Net Income (Loss) 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 full year periods ended December 31, 2009 and 2008. 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 companys 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 fourth quarter
2009 and its operating and financial performance on January 28, 2010, at 9 a.m. EST. The
conference call will be available by webcast at www.celgene.com. An audio replay of the call will
be available from noon January 28, 2010, until midnight EST February 4, 2010. To access the
replay, in the U.S. dial 888-203-1112; outside the U.S. dial 719-457-0820; and enter reservation
number 9427875. The Companys first quarter 2010 financial and operational results will be reported
in late April.
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 companys 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 Companys control. The Companys 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 Companys filings
with the Securities and Exchange Commission, such as the Companys 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.
# # #
5
Celgene Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Net product sales |
$ | 725,001 | $ | 596,122 | $ | 2,567,354 | $ | 2,137,678 | ||||||||
Collaborative agreements and other revenue |
6,764 | 4,986 | 13,743 | 14,945 | ||||||||||||
Royalty revenue |
29,272 | 27,147 | 108,796 | 102,158 | ||||||||||||
Total revenue |
761,037 | 628,255 | 2,689,893 | 2,254,781 | ||||||||||||
Cost of goods sold (excluding amortization
of acquired intangible assets) |
49,030 | 67,814 | 216,289 | 258,267 | ||||||||||||
Research and development |
201,738 | 468,568 | 794,848 | 931,218 | ||||||||||||
Selling, general and administrative |
211,564 | 200,203 | 753,827 | 685,547 | ||||||||||||
Amortization of acquired intangible assets |
16,000 | 26,125 | 83,403 | 103,967 | ||||||||||||
Acquired in-process research and development |
| | | 1,740,000 | ||||||||||||
Total costs and expenses |
478,332 | 762,710 | 1,848,367 | 3,718,999 | ||||||||||||
Operating income (loss) |
282,705 | (134,455 | ) | 841,526 | (1,464,218 | ) | ||||||||||
Equity in losses of affiliated companies |
159 | 966 | 1,103 | 9,727 | ||||||||||||
Interest and other income, net |
22,023 | 34,850 | 135,280 | 105,120 | ||||||||||||
Income (loss) before income taxes |
304,569 | (100,571 | ) | 975,703 | (1,368,825 | ) | ||||||||||
Income tax provision |
50,354 | 48,690 | 198,956 | 164,828 | ||||||||||||
Net income (loss) |
$ | 254,215 | $ | (149,261 | ) | $ | 776,747 | $ | (1,533,653 | ) | ||||||
Per common share: |
||||||||||||||||
Net income (loss) basic |
$ | 0.55 | $ | (0.33 | ) | $ | 1.69 | $ | (3.46 | ) | ||||||
Net income (loss) diluted |
$ | 0.54 | $ | (0.33 | ) | $ | 1.66 | $ | (3.46 | ) | ||||||
Weighted average shares basic |
459,223 | 458,742 | 459,304 | 442,620 | ||||||||||||
Weighted average shares diluted |
466,965 | 458,742 | 467,354 | 442,620 | ||||||||||||
December 31, | December 31, | |||||||||||||||
2009 | 2008 | |||||||||||||||
Balance sheet items: |
||||||||||||||||
Cash, cash equivalents & marketable securities |
$ | 2,996,752 | $ | 2,222,091 | ||||||||||||
Total assets |
5,375,565 | 4,445,270 | ||||||||||||||
Stockholders equity |
4,394,606 | 3,491,328 |
Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Non-GAAP Net Income (Loss)
(In thousands, except per share data)
Reconciliation of GAAP to Non-GAAP Net Income (Loss)
(In thousands, except per share data)
Three Months Ended | Twelve Months Ended | |||||||||||||||||||
December 31, | December 31, | |||||||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||||||
Net income (loss) GAAP |
$ | 254,215 | $ | (149,261 | ) | $ | 776,747 | $ | (1,533,653 | ) | ||||||||||
Before tax adjustments: |
||||||||||||||||||||
Net product sales: |
||||||||||||||||||||
Pharmion products to be divested |
(1 | ) | (3,286 | ) | (4,812 | ) | (12,654 | ) | (16,965 | ) | ||||||||||
Cost of goods sold (excluding amortization
of acquired intangible assets): |
||||||||||||||||||||
Share-based compensation expense |
(2 | ) | 1,140 | 706 | 4,444 | 2,535 | ||||||||||||||
Pharmion inventory step-up |
(3 | ) | | 5,977 | 354 | 24,646 | ||||||||||||||
Pharmion products to be divested |
(1 | ) | 2,866 | 1,934 | 8,262 | 6,950 | ||||||||||||||
EntreMed intercompany royalty |
(4 | ) | (388 | ) | (444 | ) | (585 | ) | (843 | ) | ||||||||||
Research and development: |
||||||||||||||||||||
Share-based compensation expense |
(2 | ) | 19,910 | 11,742 | 64,751 | 44,007 | ||||||||||||||
Upfront collaboration payments |
(5 | ) | | | 34,500 | 45,000 | ||||||||||||||
Purchase of VIDAZA royalty obligation |
(6 | ) | | 303,069 | | 303,069 | ||||||||||||||
Selling, general and administrative: |
||||||||||||||||||||
Share-based compensation expense |
(2 | ) | 18,240 | 18,480 | 74,624 | 60,036 | ||||||||||||||
Amortization of acquired intangible assets |
(7 | ) | 16,000 | 26,125 | 83,403 | 103,967 | ||||||||||||||
Acquired in-process research and development |
(8 | ) | | | | 1,740,000 | ||||||||||||||
Equity in losses of affiliated companies: |
||||||||||||||||||||
Equity in losses of EntreMed |
(9 | ) | 469 | 750 | 1,449 | 3,571 | ||||||||||||||
Net income tax adjustments |
(10 | ) | (18,854 | ) | (13,367 | ) | (63,973 | ) | (63,559 | ) | ||||||||||
Net income non-GAAP |
$ | 290,312 | $ | 200,899 | $ | 971,322 | $ | 718,761 | ||||||||||||
Per common share -non-GAAP: |
||||||||||||||||||||
Net income basic |
$ | 0.63 | $ | 0.44 | $ | 2.11 | $ | 1.62 | ||||||||||||
Net income diluted |
(11 | ) | $ | 0.62 | $ | 0.43 | $ | 2.08 | $ | 1.56 |
Explanation of adjustments:
(1) | Exclude sales and costs related to former non-core Pharmion Corp. products to be divested. | |
(2) | Exclude share-based compensation expense for the fourth quarter totaling $39,290 in 2009 and $30,928 in 2008. The after tax net impact reduced GAAP net income for the fourth quarter by $30,371, or $0.07 per diluted share in 2009 and $24,251, or $0.05 per diluted share in 2008. Exclude share-based compensation expense for the twelve-month periods totaling $143,819 in 2009 and $106,578 in 2008. The after tax net impact reduced GAAP net income for the twelve-month periods by $111,419, or $0.24 per diluted share in 2009 and $85,051, or $0.19 per diluted share in 2008. | |
(3) | Exclude acquisition-related Pharmion Corp. inventory step-up adjustment to fair value expensed during the period. | |
(4) | Exclude the Companys share of THALOMID royalties payable to EntreMed, Inc. | |
(5) | Exclude upfront payments for research and development collaboration arrangements with GlobeImmune, Inc. and Array BioPharma Inc. of $30,000 and $4,500, respectively, for the twelve-month period in 2009 and Acceleron Pharma, Inc. of $45,000 for the twelve-month period in 2008. | |
(6) | Exclude the purchase of VIDAZA royalty obligations related to unapproved forms. | |
(7) | Exclude amortization of acquired intangible assets for the fourth quarter of 2009 and 2008 resulting from the acquisition of Pharmion Corp. of $16,000 and $26,125, respectively. Exclude amortization of acquired intangible assets for the twelve-month periods from the acquisition of Pharmion Corp. of $83,403 in 2009 and from the acquisitions of Pharmion Corp. and Penn T of $102,330 and $1,637, respectively, in 2008. | |
(8) | Exclude the in-process research and development write-off related to the acquisition of Pharmion Corp. in the twelve-month period in 2008. | |
(9) | Exclude the Companys share of equity losses in EntreMed, Inc. | |
(10) | Net income tax adjustments reflects the estimated tax effect of the above adjustments. | |
(11) | Diluted net income per share for the three- and twelve-month periods of 2008 were determined using diluted weighted average shares of 468,477 and 461,626, respectively. |