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8-K - FORM 8-K - CELGENE CORP /DE/ | c20532e8vk.htm |
Exhibit 99.1
Contact:
Jacqualyn A. Fouse Sr. Vice President and Chief Financial Officer Celgene Corporation (908) 673-9956 |
Brian Gill Vice President Corporate Communications Celgene Corporation (908) 673-9530 |
CELGENE REPORTS RECORD SECOND QUARTER 2011
OPERATING AND FINANCIAL RESULTS
OPERATING AND FINANCIAL RESULTS
Non-GAAP Total Revenue of $1.18 Billion Increased 38 Percent Y/Y
Non-GAAP Diluted Earnings Per Share of $0.89 Increased 29 Percent Y/Y
REVLIMID® Global Net Product Sales of $795 Million Increased 35 Percent Y/Y
Increasing 2011 Revenue and Non-GAAP EPS Financial Outlook
Non-GAAP Diluted Earnings Per Share of $0.89 Increased 29 Percent Y/Y
REVLIMID® Global Net Product Sales of $795 Million Increased 35 Percent Y/Y
Increasing 2011 Revenue and Non-GAAP EPS Financial Outlook
2011 Second Quarter Financial Results Year-Over-Year
| Non-GAAP Total Revenue Increased 38 Percent to $1.18 Billion; GAAP Total Revenue $1.18
Billion |
| Global REVLIMID Net Product Sales Increased 35 Percent to $795 Million |
| Global VIDAZA® Net Product Sales Increased 23 Percent to $162 Million |
| Global ABRAXANE® Net Product Sales Reached $95 Million |
| Non-GAAP Operating Income Increased 33 Percent to $518 Million; GAAP Operating Income $319
Million |
| Non-GAAP Net Income Increased 29 Percent to $417 Million; GAAP Net Income $279 Million |
| Non-GAAP Diluted Earnings Per Share Increased 29 Percent to $0.89; GAAP Diluted Earnings
Per Share $0.59 |
2011 Financial Outlook Update
| Non-GAAP Total Revenue Expected to Increase Approximately 29 Percent Year-Over-Year to a
Range of $4.60 to $4.70 Billion, Up From a Previous Range of $4.45 to $4.55 Billion |
| REVLIMID Net Product sales Anticipated to Increase Approximately 30 Percent Year-Over-Year
to a Range of $3.15 to $3.25 Billion, Up From a Previous Range of $3.05 to $3.15 Billion |
| Non-GAAP Diluted Earnings Per Share Expected to Increase Approximately 25 Percent
Year-Over-Year to a Range of $3.45 to $3.55, Up From a Previous Range of $3.35 to $3.40 |
Recent Developments and Highlights
| Overall Survival Benefit with REVLIMID® As Continuous Therapy for Patients with Multiple
Myeloma (MM) Achieved In Intergroup Phase III Study CALGB 100104 |
| FDA Granted Accelerated Approval of ISTODAX® As Treatment for Patients with Peripheral
T-Cell Lymphoma (PTCL) Who Have Received at Least One Prior Therapy |
| GELA, the Premier Cooperative Group in Adult Lymphoma Research, Chose REVLIMID for Major
Study, RELEVANCE, in Newly-Diagnosed Follicular Lymphoma Scheduled to Start 2011 |
| Launched ABRAXANE for Metastatic Breast Cancer in the European Union |
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| ABRAXANE® Phase III Trial in Melanoma, CA033, Fully Enrolled |
| Phase II Trial Data of REVLIMID in Combination Therapy in Metastatic Castrate-Resistant
Prostate Cancer Reported 86% of Patients Achieved a 50% Reduction in PSA |
| Phase II Trial Data of REVLIMID Plus Rituximab for Untreated Indolent B-Cell Lymphoma
Reported a 91% Overall Response Rate and 65% Complete Remission Rate and Patients with
Follicular Lymphoma Achieved an 85% Complete Remission Rate |
| ACE-011(Sotatercept) Phase II/III Trial in Chemotherapy Induced Anemia in Non-Small Cell
Lung Cancer Initiated (NSCLC) |
| Phase I Study of Oral Azacitidine in Myelodysplastic Syndromes, Chronic Myelomonocytic
Leukemia, and Acute Myeloid Leukemia Published in Journal of Clinical Oncology |
2H 2011 Selected Clinical/Regulatory Objectives
Hematology
| Submit REVLIMID Newly Diagnosed Multiple Myeloma Regulatory Filing With FDA |
| Submit REVLIMID del 5q Myelodysplastic Syndromes Regulatory Filing With European Medicines
Agency |
| Launch ISTODAX in PTCL in the United States |
| Complete Enrollment of Pomalidomide Phase III Trial in Myelofibrosis |
| Complete Enrollment of Pivotal Phase II Trials Evaluating REVLIMID in Mantle Cell Lymphoma |
| Initiate Phase II/III Combination Study of REVLIMID and VIDAZA in Patients with Acute
Myeloid Leukemia |
Oncology
| Submit ABRAXANE NSCLC Supplemental New Drug Application (sNDA) to FDA |
| Complete Enrollment of ABRAXANE Phase III Trial in Pancreatic Cancer |
| Complete Enrollment of ABRAXANE Phase II Trials in Melanoma, Bladder and Ovarian Cancer |
| Complete Enrollment of REVLIMID Phase III Trial in Metastatic Castrate Resistant Prostate
Cancer |
| Advance Development Program of TORKi (mTOR Kinase Inhibitor) CC-223 |
| Advance Development Program of Oral Azacitidine in Solid Tumors |
Inflammation and Immunology
| Present Phase II Data with Apremilast in Ankylosing Spondylitis |
| Complete Enrollment of Six Phase III Trials Evaluating Apremilast in Psoriatic Arthritis (n
= 2,000), and in Moderate-to-Severe Psoriasis (n = 1,200) |
| Advance Phase II Apremilast Trial in Rheumatoid Arthritis |
| Advance Development Program of Cellular Therapy PDA-001 in Crohns Disease, Multiple
Sclerosis, Rheumatoid Arthritis, and Other Diseases |
| Advance Tanzisertib (CC-930) Phase II Study in Idiopathic Pulmonary Fibrosis |
| Advance Development of Pomalidomide in Systemic Sclerosis |
SUMMIT, NJ (July 28, 2011) Celgene Corporation (NASDAQ: CELG) announced non-GAAP (Generally
Accepted Accounting Principles) net income of $417 million, or non-GAAP diluted earnings per share
of $0.89, for the quarter ended June 30, 2011. Non-GAAP net income for the second quarter of 2010
was $323 million, or non-GAAP diluted earnings per share of $0.69. Based on U.S. GAAP, Celgene
reported net income attributable to Celgene of $279 million, or GAAP diluted earnings per share of
$0.59, for the quarter ended June 30, 2011. GAAP net income for the second quarter of 2010 was $155
million, or GAAP diluted earnings per share of $0.33.
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Celgene posted non-GAAP net income of $811 million, or non-GAAP diluted earnings per share of
$1.72, for the first six months of 2011 as compared to non-GAAP net income of $618 million or
non-GAAP diluted earnings per share of $1.32 in 2010. On a GAAP basis, Celgene reported net income
attributable to Celgene of $535 million, or diluted earnings per share of $1.14 for the first six
months of 2011, compared to GAAP net income of $390 million, or diluted earnings per share of $0.83
in 2010.
The quarterly results were outstanding, and reflect the therapeutic value of our novel therapies
for patients worldwide, said Bob Hugin, Chief Executive Officer of Celgene Corporation. We are
focused on operational excellence to leverage our global potential and drive both near and
long-term industry-leading growth and profitability.
Product Sales Performance
Non-GAAP total revenue was a record $1.18 billion for the quarter ended June 30, 2011, an increase of 38 percent over 2010. GAAP total revenue was $1.18 billion for the quarter ended June 30, 2011. The increase in total revenue was driven by global market share gains, geographic expansion and increased duration of therapy of REVLIMID® and VIDAZA®. Net sales of REVLIMID were $795 million, an increase of 35 percent over the same period in 2010. VIDAZA® net sales were $162 million, an increase of 23 percent from 2010. Global THALOMID® (inclusive of Thalidomide Celgene® and Thalidomide Pharmion®) net sales were $88 million, a decrease of 10 percent from 2010. Global ABRAXANE® net sales were $95 million.
Non-GAAP total revenue was a record $1.18 billion for the quarter ended June 30, 2011, an increase of 38 percent over 2010. GAAP total revenue was $1.18 billion for the quarter ended June 30, 2011. The increase in total revenue was driven by global market share gains, geographic expansion and increased duration of therapy of REVLIMID® and VIDAZA®. Net sales of REVLIMID were $795 million, an increase of 35 percent over the same period in 2010. VIDAZA® net sales were $162 million, an increase of 23 percent from 2010. Global THALOMID® (inclusive of Thalidomide Celgene® and Thalidomide Pharmion®) net sales were $88 million, a decrease of 10 percent from 2010. Global ABRAXANE® net sales were $95 million.
For the first six months of 2011, non-GAAP total revenue was a record $2.28 billion, an increase of
39 percent over the same period in 2010. GAAP total revenue was $2.31 billion for the first
six months of 2011. REVLIMID net sales for the first six months of 2011 reached $1.53 billion, an
increase of 37 percent over $1.12 billion for the same period in 2010. VIDAZA net sales for
the first six months of 2011 reached $325 million, an increase of 29 percent over the same period
in 2010. THALOMID net sales for the first six months of 2011 were $174 million. Global
ABRAXANE® net sales for the first six months of 2011 were $169 million.
Research and Development
For the second quarter of 2011, non-GAAP R&D expenses, which exclude share-based employee compensation expense, non-core R&D operations acquired from Abraxis and an upfront payment for an R&D collaboration agreement, were $306 million compared to $202 million for the second quarter of 2010. The increase was primarily due to support of ongoing clinical progress in multiple proprietary development programs in hematology, oncology, inflammation and immunology as well as multiple initiatives in our discovery program, peak enrollment in multiple late stage, large clinical trials and a $7 million milestone payment in the second quarter of 2011. On a GAAP basis, R&D expenses were $372 million for the second quarter of 2011 and $343 million for the same period in 2010.
For the second quarter of 2011, non-GAAP R&D expenses, which exclude share-based employee compensation expense, non-core R&D operations acquired from Abraxis and an upfront payment for an R&D collaboration agreement, were $306 million compared to $202 million for the second quarter of 2010. The increase was primarily due to support of ongoing clinical progress in multiple proprietary development programs in hematology, oncology, inflammation and immunology as well as multiple initiatives in our discovery program, peak enrollment in multiple late stage, large clinical trials and a $7 million milestone payment in the second quarter of 2011. On a GAAP basis, R&D expenses were $372 million for the second quarter of 2011 and $343 million for the same period in 2010.
Selling, General, and Administrative
Non-GAAP selling, general and administrative expenses, which exclude share-based employee compensation expense, and expenses from non-core selling, general, and administrative activities acquired from Abraxis, were $274 million for the second quarter of 2011 compared to $197 million for the second quarter of 2010. The increase was primarily due to higher marketing and sales related expenses resulting from multiple international medical meetings; ongoing product launch activities, including REVLIMID in Japan, VIDAZA in Europe, ISTODAX in the United States, and launch of ABRAXANE in the United States and Europe; as well as Abraxis integration costs. On a GAAP basis, selling, general and administrative expenses were $306 million for the second quarter of 2011 and $219 million for the same period in 2010.
Non-GAAP selling, general and administrative expenses, which exclude share-based employee compensation expense, and expenses from non-core selling, general, and administrative activities acquired from Abraxis, were $274 million for the second quarter of 2011 compared to $197 million for the second quarter of 2010. The increase was primarily due to higher marketing and sales related expenses resulting from multiple international medical meetings; ongoing product launch activities, including REVLIMID in Japan, VIDAZA in Europe, ISTODAX in the United States, and launch of ABRAXANE in the United States and Europe; as well as Abraxis integration costs. On a GAAP basis, selling, general and administrative expenses were $306 million for the second quarter of 2011 and $219 million for the same period in 2010.
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Interest and Other Income, Net
Non-GAAP interest and other income, net, was a net expense of $5 million for the second quarter of 2011, compared with a net benefit of $5 million for the second quarter of 2010, primarily due to interest expense associated with the $1.25 billion in senior notes issued in October 2010.
Non-GAAP interest and other income, net, was a net expense of $5 million for the second quarter of 2011, compared with a net benefit of $5 million for the second quarter of 2010, primarily due to interest expense associated with the $1.25 billion in senior notes issued in October 2010.
Cash, Cash Equivalents, and Marketable Securities
Cash, cash equivalents, and marketable securities totaled $2.79 billion as of June 30, 2011. Celgene repurchased 4.1 million shares during the second quarter for approximately $239 million.
Cash, cash equivalents, and marketable securities totaled $2.79 billion as of June 30, 2011. Celgene repurchased 4.1 million shares during the second quarter for approximately $239 million.
Conference Call and Webcast Information
Celgene will host a conference call to discuss the results and achievements of its second quarter 2011 and its operating and financial performance on July 28, 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 July 28, 2011, until midnight ET August 4, 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 79273910. The companys third quarter financial and operational results are expected to be reported in late October.
Celgene will host a conference call to discuss the results and achievements of its second quarter 2011 and its operating and financial performance on July 28, 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 July 28, 2011, until midnight ET August 4, 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 79273910. The companys third quarter 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 companys 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 companys Web site at www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not
historical facts. Forward-looking statements can be identified by the words expects,
anticipates, believes, intends, estimates, plans, will, outlook and similar
expressions. Forward-looking statements are based on managements current plans, estimates,
assumptions and projections, and speak only as of the date they are made. We undertake no
obligation to update any forward-looking statement in light of new information or future events,
except as otherwise required by law. Forward-looking statements involve inherent risks and
uncertainties, most of which are difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the forward-looking statements as a
result of the impact of a number of factors, many of which are discussed in more detail in our
Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.
In addition to financial information prepared in accordance with U.S. GAAP, this press release also
contains non-GAAP financial measures that we believe provide investors and management with
supplemental information relating to operating performance and trends that facilitate comparisons
between periods and with respect to projected information. These non-GAAP measures should be
considered in addition to, but not as a substitute for, the information prepared in accordance with
U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our
basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other
companies may define these measures in different ways. See the attached Reconciliations of GAAP to
non-GAAP Net Income for explanations 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, 2011 and 2010 and for the projected amounts for the year ending December 31, 2011.
4
Celgene Corporation and Subsidiaries
Condensed Consolidated Statements of Income
(Unaudited)
(In thousands, except per share data)
Condensed Consolidated Statements of Income
(Unaudited)
(In thousands, except per share data)
Three-Month Periods Ended | Six-Month Periods Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net product sales |
$ | 1,154,328 | $ | 823,097 | $ | 2,237,937 | $ | 1,582,508 | ||||||||
Collaborative agreements and other revenue |
3,399 | 2,544 | 12,702 | 4,924 | ||||||||||||
Royalty revenue |
25,428 | 27,051 | 57,797 | 56,514 | ||||||||||||
Total revenue |
1,183,155 | 852,692 | 2,308,436 | 1,643,946 | ||||||||||||
Cost of goods sold (excluding amortization of
acquired intangible assets) |
126,443 | 67,993 | 253,711 | 129,908 | ||||||||||||
Research and development |
371,520 | 342,761 | 806,998 | 547,418 | ||||||||||||
Selling, general and administrative |
305,643 | 219,262 | 607,904 | 427,241 | ||||||||||||
Amortization of acquired intangible assets |
70,087 | 47,068 | 139,137 | 88,661 | ||||||||||||
Acquisition related (gains) charges and restructuring, net |
(9,477 | ) | 7,836 | (106,221 | ) | 12,698 | ||||||||||
Total costs and expenses |
864,216 | 684,920 | 1,701,529 | 1,205,926 | ||||||||||||
Operating income |
318,939 | 167,772 | 606,907 | 438,020 | ||||||||||||
Equity in (gains) losses of affiliated companies |
(1,251 | ) | 103 | (695 | ) | (638 | ) | |||||||||
Interest and other income (expense), net |
(1,779 | ) | 4,610 | (2,383 | ) | 21,979 | ||||||||||
Income before income taxes |
318,411 | 172,279 | 605,219 | 460,637 | ||||||||||||
Income tax provision |
39,203 | 16,927 | 70,925 | 70,843 | ||||||||||||
Net income |
279,208 | 155,352 | 534,294 | 389,794 | ||||||||||||
Non-controlling interest |
190 | | 694 | | ||||||||||||
Net income attributable to Celgene |
$ | 279,398 | $ | 155,352 | $ | 534,988 | $ | 389,794 | ||||||||
Net income per common share attributable to Celgene: |
||||||||||||||||
Basic |
$ | 0.60 | $ | 0.34 | $ | 1.15 | $ | 0.85 | ||||||||
Diluted |
$ | 0.59 | $ | 0.33 | $ | 1.14 | $ | 0.83 | ||||||||
Weighted average shares basic |
462,625 | 460,309 | 464,300 | 460,112 | ||||||||||||
Weighted average shares diluted |
469,962 | 467,425 | 470,958 | 467,557 | ||||||||||||
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Balance sheet items: |
||||||||
Cash, cash equivalents &
marketable securities |
$ | 2,789,111 | $ | 2,601,301 | ||||
Total assets |
10,051,611 | 10,177,162 | ||||||
Long-term debt |
1,259,646 | 1,247,584 | ||||||
Total equity |
5,994,687 | 5,995,472 |
Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Non-GAAP Net Income
(In thousands, except per share data)
Reconciliation of GAAP to Non-GAAP Net Income
(In thousands, except per share data)
Three-Month Periods Ended | Six-Month Periods Ended | |||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||||||
Net income attributable to Celgene GAAP |
$ | 279,398 | $ | 155,352 | $ | 534,988 | $ | 389,794 | ||||||||||||
Before tax adjustments: |
||||||||||||||||||||
Net product sales: |
||||||||||||||||||||
Sales of products to be divested: |
||||||||||||||||||||
Pharmion |
(1 | ) | (1,131 | ) | (2,301 | ) | (2,203 | ) | (4,675 | ) | ||||||||||
Abraxis |
(1 | ) | (5,434 | ) | | (21,265 | ) | | ||||||||||||
Collaborative agreements and other revenue: |
||||||||||||||||||||
Abraxis non-core revenues |
(2 | ) | (809 | ) | | (1,714 | ) | | ||||||||||||
Cost of goods sold (excluding amortization
of acquired intangible assets): |
||||||||||||||||||||
Share-based compensation expense |
(3 | ) | 2,420 | 1,602 | 4,427 | 3,121 | ||||||||||||||
Abraxis inventory step-up |
(4 | ) | 41,666 | | 83,333 | | ||||||||||||||
Cost of products to be divested: |
||||||||||||||||||||
Pharmion |
(2 | ) | 1,128 | 4,397 | 2,129 | 8,683 | ||||||||||||||
Abraxis |
(2 | ) | 3,602 | | 13,151 | | ||||||||||||||
Research and development: |
||||||||||||||||||||
Share-based compensation expense |
(3 | ) | 22,880 | 20,023 | 55,472 | 39,153 | ||||||||||||||
Abraxis non-core activities |
(2 | ) | 1,879 | | 8,728 | | ||||||||||||||
IPR&D impairment |
(5 | ) | | | 118,000 | | ||||||||||||||
Upfront collaboration payments |
(6 | ) | 40,982 | 121,176 | 40,982 | 121,176 | ||||||||||||||
Selling, general and administrative: |
||||||||||||||||||||
Share-based compensation expense |
(3 | ) | 25,613 | 22,185 | 48,707 | 42,116 | ||||||||||||||
Abraxis non-core activities |
(2 | ) | 5,857 | | 15,065 | | ||||||||||||||
Amortization of acquired intangible assets: |
||||||||||||||||||||
Pharmion |
(7 | ) | 39,938 | 39,991 | 79,875 | 79,928 | ||||||||||||||
Gloucester |
(7 | ) | 7,917 | 7,077 | 14,467 | 8,733 | ||||||||||||||
Abraxis |
(7 | ) | 22,232 | | 44,795 | | ||||||||||||||
Acquisition related (gains) charges and
restructuring, net: |
||||||||||||||||||||
Gloucester contingent liability accretion |
(8 | ) | 6,108 | 5,892 | 12,161 | 10,754 | ||||||||||||||
Abraxis acquisition costs |
(8 | ) | (375 | ) | 1,944 | (326 | ) | 1,944 | ||||||||||||
Abraxis restructuring costs |
(8 | ) | 2,533 | | 5,275 | | ||||||||||||||
Change in fair value of contingent value
rights issued as part of Abraxis acquisition |
(8 | ) | (17,743 | ) | | (123,331 | ) | | ||||||||||||
Equity in (gains) losses of affiliated companies: |
||||||||||||||||||||
EntreMed, Inc. |
(9 | ) | 234 | 56 | 489 | 442 | ||||||||||||||
Abraxis non-core activities |
(2 | ) | 87 | | 1,932 | | ||||||||||||||
Interest and other income (expense), net: |
||||||||||||||||||||
Abraxis non-core activities |
(2 | ) | 6 | | 104 | | ||||||||||||||
Gain on divestment of non-core activities |
(10 | ) | (2,931 | ) | | (2,931 | ) | | ||||||||||||
Non-controlling interest: |
||||||||||||||||||||
Abraxis non-core activities |
(2 | ) | (190 | ) | | (694 | ) | | ||||||||||||
Net income tax adjustments |
(11 | ) | (58,660 | ) | (54,130 | ) | (121,020 | ) | (83,344 | ) | ||||||||||
Net income non-GAAP |
$ | 417,207 | $ | 323,264 | $ | 810,596 | $ | 617,825 | ||||||||||||
Net income
per common share non-GAAP: |
||||||||||||||||||||
Basic |
$ | 0.90 | $ | 0.70 | $ | 1.75 | $ | 1.34 | ||||||||||||
Diluted |
$ | 0.89 | $ | 0.69 | $ | 1.72 | $ | 1.32 |
Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Non-GAAP Net Income
Reconciliation of GAAP to Non-GAAP Net Income
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 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 other miscellaneous revenues, the cost
of goods sold for products to be divested as well as
operating expenses and other costs related to such activities. |
|
(3) | Exclude share-based compensation expense totaling $50,913 for the three-month period
ended June 30, 2011 and $43,810 for the three-month period
ended June 30, 2010. The after tax net impact reduced GAAP net income for the three-month
period ended June 30, 2011 by $38,496,
or $0.08 per diluted share and for the three-month period ended June 30, 2010 by $33,850, or
$0.07 per diluted share. Exclude share-based
compensation expense totaling $108,606 for the six-month period ended June 30, 2011 and
$84,390 for the six-month period ended June 30, 2010.
The after tax net impact reduced GAAP net income for the six-month period ended June 30, 2011
by $80,736, or $0.17 per diluted share and for
the six-month period ended June 30, 2010 by $65,223, or $0.14 per diluted share. |
|
(4) | Exclude acquisition-related inventory step-up adjustments to fair value which were
expensed for Abraxis in 2011. |
|
(5) | IPR&D impairment related to a reduction in the probability of obtaining progression
free survival labeling for the treatment of
non-small cell lung cancer for ABRAXANE in the United States. |
|
(6) | Exclude upfront payments for research and development collaboration arrangements
with the Institute for Advanced Health for both the three-month
and six-month periods in 2011 and with Agios Pharmaceuticals, Inc. for both the three-month
and six-month periods in 2010. |
|
(7) | Exclude amortization of acquired intangible assets from the acquisitions of
Pharmion, Gloucester Pharmaceuticals, Inc., or Gloucester and Abraxis. |
|
(8) | Exclude acquisition related (gains) charges and restructuring for Gloucester and
Abraxis. |
|
(9) | Exclude the Companys share of EntreMed, Inc. equity losses. |
|
(10) | Exclude gain recognized on divestment of non-core activities obtained in the
acquisition of Abraxis. |
|
(11) | Net income tax adjustments reflects the estimated tax effect of the above
adjustments. |
Celgene Corporation and Subsidiaries
Reconciliation of Full-Year 2011 Projected GAAP to Non-GAAP Net Income
(In thousands, except per share data)
Reconciliation of Full-Year 2011 Projected GAAP to Non-GAAP Net Income
(In thousands, except per share data)
Range | ||||||||
Low | High | |||||||
Projected net income GAAP |
$ | 1,189,000 | $ | 1,251,000 | ||||
Before tax adjustments: |
||||||||
Total Revenue: |
||||||||
Revenue from products to be divested |
(28,000 | ) | (25,000 | ) | ||||
Cost of goods sold (excluding amortization
of acquired intangible assets): |
||||||||
Share-based compensation expense |
10,000 | 9,000 | ||||||
Abraxis inventory step-up |
90,000 | 90,000 | ||||||
Cost of products to be divested |
18,000 | 17,000 | ||||||
Research and development: |
||||||||
Share-based compensation expense |
98,000 | 89,000 | ||||||
Abraxis non-core activities |
9,000 | 9,000 | ||||||
IPR&D impairment |
118,000 | 118,000 | ||||||
Upfront collaboration payments |
41,000 | 41,000 | ||||||
Selling, general and administrative: |
||||||||
Share-based compensation expense |
110,000 | 100,000 | ||||||
Abraxis non-core activities |
15,000 | 15,000 | ||||||
Amortization of acquired intangible assets |
288,000 | 288,000 | ||||||
Acquisition related (gains) charges and
restructuring, net: |
||||||||
Gloucester contingent liability accretion |
16,000 | 16,000 | ||||||
Abraxis restructuring costs |
6,000 | 6,000 | ||||||
Change in fair value of contingent value
rights issued as part of Abraxis acquisition |
(123,000 | ) | (123,000 | ) | ||||
Other non-operating items |
(2,000 | ) | (2,000 | ) | ||||
Net income tax adjustments |
(233,000 | ) | (230,000 | ) | ||||
Projected net income non-GAAP |
$ | 1,622,000 | $ | 1,669,000 | ||||
Projected net income per diluted common share GAAP |
$ | 2.53 | $ | 2.66 | ||||
Projected net income per diluted common share non-GAAP |
$ | 3.45 | $ | 3.55 | ||||
Projected weighted average diluted shares |
470,000 | 470,000 | ||||||