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Press release from Business Wire

Celgene Reports Second Quarter 2012 Operating and Financial Results

<p class='bwalignc'>  <i>Total Revenue of $1.37 Billion and Net Product Sales of $1.34 Billion, Increased 16 Percent Y/Y, Respectively</i> </p> <p class='bwalignc'>  <i>Non-GAAP Diluted Earnings per Share of $1.22, Increased 37 Percent Y/Y;</i> <i>GAAP Earnings per Share of $0.82 Increased 39 Percent Y/Y</i> </p> <p class='bwalignc'>  <i>Raising 2012 Earnings Guidance; Revenue Guidance Reaffirmed</i> </p> <p class='bwalignc'> <i>Key Pivotal Data for ABRAXANE</i><sup><i>®</i></sup><i>, Apremilast, Pomalidomide and REVLIMID</i><sup><i>®</i></sup><i> Expected by Year-end</i> </p>

Thursday, July 26, 2012

Celgene Reports Second Quarter 2012 Operating and Financial Results07:30 EDT Thursday, July 26, 2012 SUMMIT, N.J. (Business Wire) -- Celgene Corporation (NASDAQ: CELG) reported total revenue of $1,367 million for the second quarter of 2012, a 16 percent increase from the same period in 2011. Non-GAAP net income for the second quarter of 2012 increased 31 percent to $545 million compared to $417 million in the second quarter of 2011. For the same periods, non-GAAP diluted earnings per share increased 37 percent to $1.22 from $0.89. Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported second quarter 2012 net income of $367 million or $0.82 per diluted share. For the second quarter of 2011, net income was $279 million or $0.59 per diluted share. “The second quarter financial results were very strong and provide significant momentum for the second half of the year,” said Bob Hugin, Chairman and Chief Executive Officer of Celgene Corporation. “The recent positive apremilast phase III data is the first of multiple pivotal trial results and regulatory actions across our portfolio anticipated through early 2013. We have never been in a better position to deliver on our promise of helping to improve patients' lives and provide value for our shareholders.” Raising 2012 Earnings Outlook; Revenue Guidance Reaffirmed Non-GAAP diluted EPS is expected to increase approximately 27 percent year-over-year to a range of $4.80 to$4.85, up from a previous range of $4.70 to$4.80. GAAP diluted EPS is expected to increase approximately 31 percent year-over-year to a range of $3.69 to $3.80, up from the previous range of $3.52 to $3.67. Non-GAAP total revenue is expected to increase approximately 15 percent year-over-year to a range of $5,400 to $5,600 million. REVLIMID net product sales are expected to increase approximately 19 percent year-over-year to a range of $3,750 to $3,850 million. Second Quarter 2012 Financial Highlights Unless otherwise stated, all comparisons are for the second quarter of 2012 compared to the second quarter of 2011. The non-GAAP operating expenses presented below exclude share-based employee compensation expense, upfront collaboration payments, non-core operations acquired from Abraxis, and IPR&D impairments. Net Product Sales Performance Net product sales increased 16% to $1,337 million and reflect strong volume growth in the U.S., Europe and Japan. U.S. and international net product sales of $772 million and $565 million increased 15 percent and 19 percent, respectively. REVLIMID sales for the second quarter increased 17 percent to $934 million and were driven by overall market share gains, increased duration of therapy and geographic expansion. U.S. sales of $537 million and international sales of $397 million increased 17 percent and 18 percent, respectively. ABRAXANE sales for the second quarter were $110 million, a 16 percent increase. U.S. sales of $87 million and international sales of $23 million increased 20 percent and 3 percent, respectively. VIDAZA® second quarter sales increased 24 percent to $201 million. U.S. sales increased 12 percent to $82 million. International sales increased 35 percent to $119 million, driven by underlying patient demand in Europe and Japan. THALOMID® sales were $76 million in the second quarter, representing a 13 percent decrease. Research and Development (R&D) Non-GAAP R&D expenses were $349 million for the second quarter compared to $306 million for the second quarter of 2011. The change is primarily due to increased clinical costs associated with advancing the mid- to late-stage pipeline and the absorption of the Avila Therapeutics acquisition which closed in March 2012. On a GAAP basis, R&D expenses were $447 million for the second quarter of 2012 and $372 million for the same period in 2011. Selling, General, and Administrative (SG&A) Non-GAAP SG&A expenses were $296 million for the second quarter of 2012 compared to $274 million for the second quarter of 2011. The change was primarily due to increased ABRAXANE and REVLIMID marketing, in addition to pomalidomide prelaunch activities. On a GAAP basis, SG&A expenses were $323 million for the second quarter of 2012 compared to $306 million for the same period in 2011. Cash, Cash Equivalents, and Marketable Securities Operating cash flow was $947 million for the first six months of 2012, an increase of 29 percent compared to 2011. Under our authorized stock repurchase program, we purchased approximately 8.1 million shares during the second quarter of 2012 at a total cost of approximately $558 million. As of June 30, 2012, we had $3,161 million remaining under the existing stock repurchase program that includes the additional $2,500 million authorization that the Board of Directors approved in mid-June. During the second quarter of 2012, we made upfront payments to Epizyme and Inhibrx totaling $75 million related to the formation of strategic collaborations with both companies. We ended the second quarter with $2,562 million in cash and marketable securities. Key Accomplishments During the First Half of 2012Hematology Submitted the REVLIMID marketing application for myelodysplastic syndromes (MDS) deletion 5q to the European Medicines Agency (EMA). Submitted the pomalidomide marketing applications for relapsed refractory multiple myeloma (RRMM) to the Food and Drug Administration (FDA) and EMA. Completed enrollment in the phase III pomalidomide trial (MF-002) for myelofibrosis. Publication in the New England Journal of Medicine of three phase III REVLIMID trials in newly diagnosed multiple myeloma (MM-015, IFM 2005-02, and CALGB 100104).Oncology Completed enrollment in the ABRAXANE phase III trial in metastatic pancreatic cancer. Publication of the phase III ABRAXANE non-small cell lung cancer trial in the Journal of Clinical Oncology.Inflammation & Immunology Reported the phase III apremilast trial in psoriatic arthritis (PALACE-1) achieved its primary endpoint and key secondary endpoints. Initiated phase III apremilast trial for ankylosing spondylitis (POSTURE). Publications of the phase II apremilast psoriatic arthritis trial (PSA-001) in the journal Arthritis & Rheumatism and the phase II psoriasis trial (PSOR-005) in theLancet.Key Milestones Expected During the Second Half of 2012Hematology Phase III data with pomalidomide in relapsed refractory multiple myeloma (MM-003). Phase III data with pomalidomide in myelofibrosis (MF-002). Pivotal phase II data with REVLIMID in relapsed refractory mantle cell lymphoma (EMERGE). Data from the phase II portion of the phase II/III REVLIMID trial in diffuse large B cell non-Hodgkin's lymphoma (DLC-001). Initiate phase III trial with CC-486 (oral azacitidine) in MDS. Committee for Medicinal Products for Human Use (CHMP) decision on REVLIMID for MDS deletion 5q. REVLIMID approval for relapsed refractory multiple myeloma in Brazil and China. Complete enrollment in phase III REVLIMID trial in chronic lymphocytic leukemia (ORIGIN / CLL-008). Oncology Phase III ABRAXANE data in melanoma. Phase III ABRAXANE data in metastatic pancreatic cancer. Receive FDA decision on ABRAXANE for non-small cell lung cancer. Inflammation & Immunology Phase III apremilast data in psoriatic arthritis (PALACE-2 and PALACE-3). Phase III apremilast data in psoriasis (ESTEEM-1). Second Quarter 2012 Conference Call and Webcast Information We are hosting a conference call to discuss the second quarter 2012 operating and financial performance on Thursday, July 26, 2012, at 9:00 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 26, 2012, until midnight ET August 3, 2012. To access the replay, in the U.S. dial 800-585-8367; international dial 404-537-3406; and Participant Pass code 99589605. Our third quarter 2012 financial and operational results are expected to be reported in late October. About REVLIMID In the U.S., REVLIMID (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy. REVLIMID is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. 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 formetastatic 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 StatementsThis 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 SubsidiariesCondensed 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 SubsidiariesReconciliation 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 SubsidiariesReconciliation 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 Celgene CorporationInvestors:Patrick E. Flanigan III, (908) 673-9969Vice PresidentInvestor RelationsorMedia:Brian P. Gill, (908) 673-9530Vice PresidentCorporate Communications