Celgene Reports Second Quarter 2012 Operating And Financial Results
About ABRAXANE
In the U.S., ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six month of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
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.
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 management’s 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- and six-month periods ended June 30, 2012 and 2011, and for the projected amounts for the year ending December 31, 2012.| Celgene Corporation and Subsidiaries | |||||||||||||||||||||||||
| Condensed Consolidated Statements of Income | |||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||||||||||
| Three-Month Periods Ended June 30, | Six-Month Periods Ended June 30, | ||||||||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||||||||||
| Net product sales | $ | 1,336,590 | $ | 1,154,328 | $ | 2,582,089 | $ | 2,237,937 | |||||||||||||||||
| Other revenue | 30,174 | 28,827 | 57,963 | 70,499 | |||||||||||||||||||||
| Total revenue | 1,366,764 | 1,183,155 | 2,640,052 | 2,308,436 | |||||||||||||||||||||
| Cost of goods sold (excluding amortization of | |||||||||||||||||||||||||
| acquired intangible assets) | 71,852 | 126,443 | 144,372 | 253,711 | |||||||||||||||||||||
| Research and development | 447,098 | 371,520 | 809,142 | 806,998 | |||||||||||||||||||||
| Selling, general and administrative | 323,027 | 305,643 | 648,805 | 607,904 | |||||||||||||||||||||
| Amortization of acquired intangible assets | 44,148 | 70,087 | 85,908 | 139,137 | |||||||||||||||||||||
| Acquisition related (gains) charges and restructuring, net | 39,285 | (9,477 | ) | 28,215 | (106,221 | ) | |||||||||||||||||||
| Total costs and expenses | 925,410 | 864,216 | 1,716,442 | 1,701,529 | |||||||||||||||||||||
| Operating income | 441,354 | 318,939 | 923,610 | 606,907 | |||||||||||||||||||||
| Other income (expense), net | (670 | ) | (528 | ) | (8,924 | ) | (1,688 | ) | |||||||||||||||||
| Income before income taxes | 440,684 | 318,411 | 914,686 | 605,219 | |||||||||||||||||||||
| Income tax provision | 73,311 | 39,203 | 145,776 | 70,925 | |||||||||||||||||||||
| Net income | 367,373 | 279,208 | 768,910 | 534,294 | |||||||||||||||||||||
| Non-controlling interest | - | 190 | - | 694 | |||||||||||||||||||||
| Net income attributable to Celgene | $ | 367,373 | $ | 279,398 | $ | 768,910 | $ | 534,988 | |||||||||||||||||
| Net income per share attributable to Celgene: | |||||||||||||||||||||||||
| Basic | $ | 0.84 | $ | 0.60 | $ | 1.76 | $ | 1.15 | |||||||||||||||||
| Diluted | $ | 0.82 | $ | 0.59 | $ | 1.72 | $ | 1.14 | |||||||||||||||||
| Weighted average shares: | |||||||||||||||||||||||||
| Basic | 436,703 | 462,625 | 437,526 | 464,300 | |||||||||||||||||||||
| Diluted | 445,379 | 469,962 | 447,092 | 470,958 | |||||||||||||||||||||
| June 30, | December 31, | ||||||||||||
| 2012 | 2011 | ||||||||||||
| Balance sheet items: | |||||||||||||
| Cash, cash equivalents & marketable securities | $ | 2,561,544 | $ | 2,648,154 | |||||||||
| Total assets | 10,381,207 | 10,005,910 | |||||||||||
| Short-term borrowings | 390,434 | 526,684 | |||||||||||
| Long-term debt | 1,272,112 | 1,275,585 | |||||||||||
| Total stockholders' equity | 5,958,028 | 5,512,727 | |||||||||||
| Celgene Corporation and Subsidiaries | |||||||||||||||||||||||||||
| Reconciliation of GAAP to Non-GAAP Net Income | |||||||||||||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||||||||||||
| Three-Month Periods Ended June 30, | Six-Month Periods Ended June 30, | ||||||||||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||||||||||||
| Net income attributable to Celgene - GAAP | $ | 367,373 | $ | 279,398 | $ | 768,910 | $ | 534,988 | |||||||||||||||||||
| Before tax adjustments: | |||||||||||||||||||||||||||
| Total revenues: | |||||||||||||||||||||||||||
| Sales of products exited or to be exited | (1 | ) | - | (6,565 | ) | - | (23,468 | ) | |||||||||||||||||||
| Abraxis non-core other revenues | (2 | ) | - | (809 | ) | - | (1,714 | ) | |||||||||||||||||||
| Cost of goods sold (excluding amortization | |||||||||||||||||||||||||||
| of acquired intangible assets): | |||||||||||||||||||||||||||
| Share-based compensation expense | (3 | ) | 2,983 | 2,420 | 5,859 | 4,427 | |||||||||||||||||||||
| Abraxis inventory step-up | (4 | ) | - | 41,666 | - | 83,333 | |||||||||||||||||||||
| Products exited or to be exited | (2 | ) | (572 | ) | 4,730 | (1,981 | ) | 15,280 | |||||||||||||||||||
| Research and development: | |||||||||||||||||||||||||||
| Share-based compensation expense | (3 | ) | 23,556 | 22,880 | 48,584 | 55,472 | |||||||||||||||||||||
| Abraxis non-core activities | (2 | ) | - | 1,879 | - | 8,728 | |||||||||||||||||||||
| IPR&D impairments | (5 | ) | - | - | 22,151 | 118,000 | |||||||||||||||||||||
| Upfront collaboration payments | (6 | ) | 75,000 | 40,982 | 75,000 | 40,982 | |||||||||||||||||||||
| Selling, general and administrative: | |||||||||||||||||||||||||||
| Share-based compensation expense | (3 | ) | 27,075 | 25,613 | 53,891 | 48,707 | |||||||||||||||||||||
| Abraxis non-core activities | (2 | ) | - | 5,857 | - | 15,065 | |||||||||||||||||||||
| Amortization of acquired intangible assets | (7 | ) | 44,148 | 70,087 | 85,908 | 139,137 | |||||||||||||||||||||
| Acquisition related (gains) charges and restructuring, net: | |||||||||||||||||||||||||||
| Change in fair value of contingent consideration | (8 | ) | 38,071 | (11,635 | ) | 25,638 | (111,170 | ) | |||||||||||||||||||
| Acquisition and restructuring costs | (8 | ) | 1,214 | 2,158 | 2,577 | 4,949 | |||||||||||||||||||||
| Other income (expense), net | |||||||||||||||||||||||||||
| EntreMed, Inc. equity method loss | (9 | ) | - | 234 | - | 489 | |||||||||||||||||||||
| Abraxis non-core activities | (2 | ) | - | 93 | - | 2,036 | |||||||||||||||||||||
| Gain on divestment of non-core activities | (10 | ) | - | (2,931 | ) | - | (2,931 | ) | |||||||||||||||||||
| Non-controlling interest -Abraxis | (2 | ) | - | (190 | ) | - | (694 | ) | |||||||||||||||||||
| Net income tax adjustments | (11 | ) | (34,296 | ) | (58,660 | ) | (57,556 | ) | (121,020 | ) | |||||||||||||||||
| Net income attributable to Celgene - non-GAAP | $ | 544,552 | $ | 417,207 | $ | 1,028,981 | $ | 810,596 | |||||||||||||||||||
| Net income per share attributable to Celgene -non-GAAP: | |||||||||||||||||||||||||||
| Basic | $ | 1.25 | $ | 0.90 | $ | 2.35 | $ | 1.75 | |||||||||||||||||||
| Diluted | $ | 1.22 | $ | 0.89 | $ | 2.30 | $ | 1.72 | |||||||||||||||||||
| 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- and six-month periods ended June 30, 2012 and 2011, and for the projected amounts for the year ending December 31, 2012. |
| Celgene Corporation and Subsidiaries | ||
| Reconciliation of GAAP to Non-GAAP Net Income | ||
| Explanation of adjustments: | ||
| (1) | Exclude sales related to non-core former Pharmion Corp., or Pharmion, products to be exited and Abraxis BioScience Inc., or Abraxis, products that | |
| have been exited. | ||
| (2) | Exclude the estimated impact of activities arising from the acquisition of Abraxis that are not related to core nab technology and | |
| were divested in 2011, including other miscellaneous revenues, cost of goods sold (excluding amortization of acquired intangible assets), operating | ||
| expenses and other costs related to such activities. Exclude the net (benefit) cost of activities arising from the acquisition of Pharmion that | ||
| are planned to be exited. | ||
| (3) | Exclude share-based compensation expense totaling $53,614 for the three-month period ended June 30, 2012 and $50,913 for the three-month | |
| period ended June 30, 2011. Exclude share-based compensation expense totaling $108,334 for the six-month period ended June 30, 2012 and | ||
| $108,606 for the six-month period ended June 30, 2011. | ||
| (4) | Exclude acquisition-related inventory step-up adjustments to fair value which were expensed for Abraxis in 2011. | |
| (5) | Exclude in-process research and development, or IPR&D, impairment for the six-month period ended June 30, 2012 related to the timing of obtaining | |
| approval for ISTODAX for the treatment of peripheral T-cell lymphoma, or PTCL, in the European Union. Exclude IPR&D impairment for the | ||
| six-month period ended June 30, 2011 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. | |
| (7) | Exclude amortization of intangible assets acquired from the acquisitions of Pharmion, Gloucester Pharmaceuticals, Inc., or Gloucester, Abraxis | |
| and Celgene Avilomics Research, Inc. (formerly known as Avila Therapeutics), or Avila. | ||
| (8) | Exclude acquisition related charges and restructuring related to Gloucester, Abraxis and Avila. | |
| (9) | Exclude the Company's share of EntreMed, Inc. equity losses in 2011. | |
| (10) | Exclude the 2011 gain recognized on divestment of non-core activities obtained in the acquisition of Abraxis. | |
| (11) | Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments, | |
| including one-time effects of changes in tax law, acquisition related matters, an adjustment to the amount of unrecognized tax benefits and deferred | ||
| taxes on unremitted foreign earnings. | ||
| Celgene Corporation and Subsidiaries | |||||||||||
| Reconciliation of Full-Year 2012 Projected GAAP to Non-GAAP Net Income | |||||||||||
| (In thousands, except per share data) | |||||||||||
| Range | |||||||||||
| Low | High | ||||||||||
| Projected net income - GAAP | $ 1,641,000 | $ 1,692,000 | |||||||||
| Before tax adjustments: | |||||||||||
| Cost of goods sold (excluding amortization | |||||||||||
| of acquired intangible assets): | |||||||||||
| Share-based compensation expense | 11,000 | 10,000 | |||||||||
| Research and development: | |||||||||||
| Share-based compensation expense | 121,000 | 109,000 | |||||||||
| IPR&D impairment | 57,000 | 52,000 | |||||||||
| Upfront collaboration payments | 75,000 | 75,000 | |||||||||
| Selling, general and administrative: | |||||||||||
| Share-based compensation expense | 118,000 | 107,000 | |||||||||
| Amortization of acquired intangible assets | 178,000 | 178,000 | |||||||||
| Acquisition related (gains) charges and restructuring, net: | |||||||||||
| Change in fair value of contingent consideration | 41,000 | 36,000 | |||||||||
| Acquisition and restructuring costs | 4,000 | 3,000 | |||||||||
| Net income tax adjustments | (110,000) | (104,000) | |||||||||
| Projected net income - non-GAAP | $ 2,136,000 | $ 2,158,000 | |||||||||
| Projected net income per diluted common share - GAAP | $ 3.69 | $ 3.80 | |||||||||
| Projected net income per diluted common share - non-GAAP | $ 4.80 | $ 4.85 | |||||||||
| Projected weighted average diluted shares | 445,000 | 445,000 | |||||||||
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