Net product sales for the full year of 2014 were
Based on U.S. GAAP (Generally Accepted Accounting Principles),
"2014 was an outstanding year for
Fourth Quarter and Full Year 2014 Financial Highlights
Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2014 compared to the fourth quarter and full year of 2013. The adjusted operating expense categories presented below exclude share-based employee compensation expense, in-process research and development (IPR&D) impairments, upfront collaboration payments and settlement of contingent obligations. Adjusted diluted EPS, GAAP EPS and share counts for all periods have been adjusted to reflect the two-for-one stock split effected in
Net Product Sales Performance
-
REVLIMID® sales for the fourth quarter increased 16 percent to
$1,322 million and were driven by increased market share and duration of therapy. Fourth quarter U.S. sales of$797 million and international sales of$525 million increased 20 percent and 11 percent, respectively. Full year REVLIMID® sales were$4,980 million , an increase of 16 percent. -
ABRAXANE® sales for the fourth quarter were
$236 million , an increase of 17 percent. U.S. sales were$172 million and international sales were$64 million , an increase of 8 percent and 50 percent, respectively. Sales of ABRAXANE® in the U.S. were positively impacted from increased use in non-small cell lung cancer (NSCLC) and pancreatic cancer. Volume inEurope increased from the launch in pancreatic cancer. Full year ABRAXANE® sales were$848 million , an increase of 31 percent. -
POMALYST®/IMNOVID® sales for the fourth quarter were
$202 million . U.S. sales were$132 million and international sales were$70 million . Full year POMALYST®/IMNOVID® sales were$680 million . Sales were driven by increased market share and duration gains. 2014 was the first full year of sales after 2013 approvals in the U.S. andEurope . -
VIDAZA® fourth quarter sales were
$154 million , an 8 percent decrease year-over year. U.S. sales decreased 67 percent to$9 million impacted by the introduction of generic azacitidine inSeptember 2013 . International sales increased 3 percent to$145 million . Full year VIDAZA® sales were$612 million , a decrease of 24 percent. -
OTEZLA® sales in the fourth quarter were
$47 million . Full year OTEZLA® sales were$70 million . New and total prescriptions continue to grow for the psoriatic arthritis indication and have significantly accelerated in the fourth quarter of 2014 following the U.S. approval for psoriasis. -
In the fourth quarter, all other product sales, which include THALOMID®, ISTODAX® and an authorized generic of VIDAZA® drug product in the U.S., were
$93 million compared to$98 million in the fourth quarter of 2013. Full year sales for these products were$374 million .
Research and Development (R&D)
Adjusted R&D expenses were
For the full year of 2014, adjusted R&D expenses were
On a GAAP basis, R&D expenses were
Selling, General, and Administrative (SG&A)
Adjusted SG&A expenses were
On a GAAP basis, SG&A expenses were
Cash, Cash Equivalents, and
Operations generated cash flow of
Product and Pipeline Updates
Hematology
REVLIMID®: In December, the
At the 2014
At ASH, data were presented from a phase II randomized trial (MCL-002 SPRINT) comparing REVLIMID® with investigators' choice of therapy in patients with relapsed and/or refractory mantle cell lymphoma and from a phase II trial (DLC-001) of REVLIMID® compared with investigators' choice of therapy in patients with relapsed and/or refractory diffuse large b-cell lymphoma (DLBCL). The Company will initiate enrollment in the phase III ROBUSTTM trial comparing REVLIMID® in combination with R-CHOP to placebo plus R-CHOP in newly diagnosed DLBCL in the first quarter of 2015.
Also at the ASH meeting, data from two sub-group analyses from the phase III AML-001 trial with VIDAZA® compared with conventional care regimens in elderly subjects with newly diagnosed acute myeloid leukemia (AML) were presented. In December, a submission was made to the EMA for approval of VIDAZA® in elderly AML. An opinion from the EMA's CHMP is expected by year-end 2015.
Oncology
In January, the EMA's CHMP adopted a positive opinion for ABRAXANE® in combination with carboplatin for the first-line treatment of NSCLC in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. A decision is expected from the
At the
In December, ABRAXANE® was approved by
Inflammation & Immunology
OTEZLA®: In January, the EC granted marketing authorization for OTEZLA® for two indications. One is for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). The second indication is for OTEZLA® alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. Additional regulatory decisions for OTEZLA® in other geographies are expected in 2015.
In December, the phase III RELIEFTM trial (BCT-002) comparing OTEZLA® to placebo in patients with active Behçet's disease began enrollment. Additionally, a phase II trial for OTEZLA® in ulcerative colitis was initiated in the fourth quarter of 2014.
At the
At the 2014
GED-0301 (mongersen): At the
Sotatercept: At the
2015 Expected Operating Milestones
Hematology/Oncology
-
FDA decision on REVLIMID® for newly diagnosed multiple myeloma (NDMM) - EC decision on REVLIMID® for elderly non-transplant eligible NDMM
-
Decision in
Japan on REVLIMID® for NDMM - Submission of REVLIMID® for non-deletion 5q myelodysplastic syndrome (MDS) in the U.S.
- Discuss submission of REVLIMID® for non-deletion 5q MDS with regulatory authorities in additional geographies
- Initiate a phase III trial with REVLIMID® maintenance in patients with NDMM who are post stem cell transplant and are minimal residual disease (MRD) positive
- Data from the FLASH (Follicular Lymphoma Analysis of Surrogacy Hypothesis) Group meta-analysis of durable complete response as a surrogate for progression-free survival in follicular lymphoma to be presented at a medical congress
- Initiate enrollment in the phase III ROBUSTTM trial with REVLIMID® in newly diagnosed DLBCL
- Complete enrollment in the phase III CONTINUUM® trial of REVLIMID® as maintenance in second-line chronic lymphocytic leukemia (CLL)
-
Continue geographic expansion of REVLIMID® in RRMM, notably in
Russia ,Mexico andBrazil -
Decision on POMALYST® in
Japan for relapsed and/or refractory multiple myeloma - Opinion from the EMA's CHMP on VIDAZA® for elderly acute myeloid leukemia (AML)
- Advance the phase I/II trials with CC-122 as monotherapy and combination therapy in DLBCL and CLL
- Advance the programs with sotatercept and/or luspatercept in beta-thalassemia and MDS
- Initiate pivotal program with AG-221 in patients with IDH-2 mutated AML
- EC decision on ABRAXANE® in non-small cell lung cancer
I&I
- Expand OTEZLA® commercialization in key geographies
- Complete enrollment in the phase II trial of OTEZLA® for atopic dermatitis
- Publish results of phase II trial of GED-0301 in Crohn's disease in a major medical journal
- Complete enrollment of the registration-enabling endoscopy trial for GED-0301 in Crohn's disease
- Initiate enrollment in two 52-week phase III trials of GED-0301 in Crohn's disease
- Initiate clinical program in ulcerative colitis for GED-0301
- Complete enrollment in the phase IIb trial with sotatercept in end-stage renal disease patients with anemia
- Complete enrollment in the phase II trial with CC-220 in patients with systemic lupus erythematosus
2015 Guidance
-
Total net product sales are expected to be
$9,000 million to$9,500 million , an increase of 22.3 percent year-over-year based on the mid-point of the range and includes a negative impact from foreign exchange approaching$100 million -
REVLIMID® net sales are expected to be in the range of
$5,600 million to$5,700 million , an increase of 13.5 percent year-over-year based on the mid-point of the range -
ABRAXANE® net sales are expected to be in the range of
$1,000 million to$1,250 million , an increase of 32.6 percent year-over-year based on the mid-point of the range - Adjusted operating margin is expected to be approximately 52 percent after investments across the entire organization, a 140 basis points improvement over 2014. GAAP operating margin is expected to be approximately 41.7 percent
-
Adjusted diluted EPS is expected to be in the range of
$4.60 to$4.75 , an increase of approximately 26.0 percent year-over-year based on the mid-point of the range. GAAP diluted EPS is expected to be in the range of$3.68 to$3.92
Please see the attached Reconciliation of Full Year 2015 Projected GAAP to Adjusted Net Income for further information.
2017 and 2020 Long-term Financial Targets
At the 33rd Annual
-
2017 financial targets:
-
Net product sales target of
$13,000 million to$14,000 million -
2017 net product sales expected to be:
-
REVLIMID®:
$7,000 million -
POMALYST®/IMNOVID®:
$1,500 million -
ABRAXANE®:
$1,500 million to$2,000 million -
OTEZLA®:
$1,500 million to$2,000 million
-
REVLIMID®:
-
Adjusted diluted EPS is expected to be approximately
$7.50 - Fully diluted share count is expected to be approximately 830 million
-
Net product sales target of
-
2020 financial targets:
-
2020 net product sales expected to exceed
$20,000 million -
Hematology franchise expected to exceed
$14,800 million -
Oncology franchise expected to exceed
$2,200 million -
I&I franchise expected to exceed
$3,000 million
-
Hematology franchise expected to exceed
-
Adjusted diluted EPS is expected to exceed
$12.50 - Fully diluted share count is expected to be approximately 830 million
-
2020 net product sales expected to exceed
Q4 and Full year 2014 Conference Call and Webcast Information
About
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. REVLIMID® is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Limitations of Use: REVLIMID® is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
About VIDAZA®
In the U.S., VIDAZA® (azacitidine for injection) is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
About POMALYST®
In the U.S., POMALYST® (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit such as improvement in survival or symptoms has not been verified.
About ABRAXANE®
In the U.S., ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE® is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE® is also indicated for the first-line treatment of metastatic adenocarcinoma of the pancreas in combination with gemcitabine.
About OTEZLA®
In the U.S., OTEZLA® (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis. OTEZLA® is indicated in the U.S. for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
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
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted 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 adjusted financial measures are non-GAAP and 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 Reconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP) Measures for explanations of the amounts excluded and included to arrive at the adjusted measures for the three- and twelve-month periods ended
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Condensed Consolidated Statements of Income | ||||||||||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||||||||||
(In millions, except per share data) | ||||||||||||||||||||||||||||||||
Three-Month Periods Ended | Twelve-Month Periods Ended | |||||||||||||||||||||||||||||||
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2014 | 2013 | 2014 | 2013 | |||||||||||||||||||||||||||||
Net product sales | $ | 2,054.9 | $ | 1,724.9 | $ | 7,563.8 | $ | 6,362.3 | ||||||||||||||||||||||||
Other revenue | 30.6 | 31.0 | 106.6 | 131.6 | ||||||||||||||||||||||||||||
Total revenue | 2,085.5 | 1,755.9 | 7,670.4 | 6,493.9 | ||||||||||||||||||||||||||||
Cost of goods sold (excluding amortization of | ||||||||||||||||||||||||||||||||
acquired intangible assets) | 103.2 | 92.8 | 385.9 | 340.4 | ||||||||||||||||||||||||||||
Research and development | 584.9 | 731.2 | 2,430.6 | 2,226.2 | ||||||||||||||||||||||||||||
Selling, general and administrative | 544.4 | 448.7 | 2,027.9 | 1,684.5 | ||||||||||||||||||||||||||||
Amortization of acquired intangible assets | 63.6 | 65.7 | 258.3 | 262.8 | ||||||||||||||||||||||||||||
Acquisition related charges, net | 37.7 | 91.7 | 48.7 | 171.1 | ||||||||||||||||||||||||||||
Total costs and expenses | 1,333.8 | 1,430.1 | 5,151.4 | 4,685.0 | ||||||||||||||||||||||||||||
Operating income | 751.7 | 325.8 | 2,519.0 | 1,808.9 | ||||||||||||||||||||||||||||
Interest and investment income, net | 7.6 | 7.4 | 28.2 | 22.0 | ||||||||||||||||||||||||||||
Interest (expense) | (51.7 | ) | (30.1 | ) | (176.1 | ) | (91.6 | ) | ||||||||||||||||||||||||
Other income (expense), net | 3.2 | (85.9 | ) | (43.7 | ) | (73.9 | ) | |||||||||||||||||||||||||
Income before income taxes | 710.8 | 217.2 | 2,327.4 | 1,665.4 | ||||||||||||||||||||||||||||
Income tax provision | 96.9 | 2.8 | 327.5 | 215.5 | ||||||||||||||||||||||||||||
Net income | $ | 613.9 | $ | 214.4 | $ | 1,999.9 | $ | 1,449.9 | ||||||||||||||||||||||||
Net income per common share:(1) | ||||||||||||||||||||||||||||||||
Basic | $ | 0.77 | $ | 0.26 | $ | 2.49 | $ | 1.75 | ||||||||||||||||||||||||
Diluted | $ | 0.74 | $ | 0.25 | $ | 2.39 | $ | 1.68 | ||||||||||||||||||||||||
Weighted average shares:(1) | ||||||||||||||||||||||||||||||||
Basic | 800.2 | 822.4 | 802.7 | 827.7 | ||||||||||||||||||||||||||||
Diluted | 834.6 | 857.2 | 836.0 | 860.6 | ||||||||||||||||||||||||||||
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2014 | 2013 | |||||||||||||||||||||||||||||||
Balance sheet items: | ||||||||||||||||||||||||||||||||
Cash, cash equivalents & marketable securities | $ | 7,546.7 | $ | 5,687.0 | ||||||||||||||||||||||||||||
Total assets | 17,340.1 | 13,378.2 | ||||||||||||||||||||||||||||||
Short-term borrowings | 605.9 | 544.8 | ||||||||||||||||||||||||||||||
Long-term debt | 6,265.7 | 4,196.5 | ||||||||||||||||||||||||||||||
Total stockholders' equity | 6,524.8 | 5,589.9 | ||||||||||||||||||||||||||||||
(1) |
Following stockholder approval, the Company amended its certificate of incorporation on |
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|||||||||||||||||||||||||||||||||||||
Reconciliation of GAAP to Adjusted Net Income | |||||||||||||||||||||||||||||||||||||
(In millions, except per share data) | |||||||||||||||||||||||||||||||||||||
Three-Month Periods Ended | Twelve-Month Periods Ended | ||||||||||||||||||||||||||||||||||||
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2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||||||||||||||||
Net income - GAAP | $ | 613.9 | $ | 214.4 | $ | 1,999.9 | $ | 1,449.9 | |||||||||||||||||||||||||||||
Before tax adjustments: | |||||||||||||||||||||||||||||||||||||
Cost of goods sold (excluding amortization | |||||||||||||||||||||||||||||||||||||
of acquired intangible assets): | |||||||||||||||||||||||||||||||||||||
Share-based compensation expense | (1 | ) | 7.4 | 5.9 | 26.2 | 18.5 | |||||||||||||||||||||||||||||||
Research and development: | |||||||||||||||||||||||||||||||||||||
Share-based compensation expense | (1 | ) | 55.3 | 44.2 | 196.5 | 144.7 | |||||||||||||||||||||||||||||||
Upfront collaboration expense | (2 | ) | 52.0 | 227.0 | 453.6 | 575.8 | |||||||||||||||||||||||||||||||
IPR&D impairment | (3 | ) | - | - | 129.2 | - | |||||||||||||||||||||||||||||||
Selling, general and administrative: | |||||||||||||||||||||||||||||||||||||
Share-based compensation expense | (1 | ) | 65.7 | 48.3 | 224.9 | 162.6 | |||||||||||||||||||||||||||||||
Settlement of contingent obligation | (4 | ) | - | - | 25.0 | - | |||||||||||||||||||||||||||||||
Amortization of acquired intangible assets | (5 | ) | 63.6 | 65.7 | 258.3 | 262.8 | |||||||||||||||||||||||||||||||
Acquisition related charges, net: | |||||||||||||||||||||||||||||||||||||
Change in fair value of contingent consideration | (6 | ) | 37.7 | 91.7 | 48.7 | 171.1 | |||||||||||||||||||||||||||||||
Other income (expense), net | |||||||||||||||||||||||||||||||||||||
Non-operating asset impairment | (7 | ) | - | 80.0 | - | 80.0 | |||||||||||||||||||||||||||||||
Net income tax adjustments | (8 | ) | (55.4 | ) | (128.2 | ) | (263.7 | ) | (302.3 | ) | |||||||||||||||||||||||||||
Net income - Adjusted | $ | 840.2 | $ | 649.0 | $ | 3,098.6 | $ | 2,563.1 | |||||||||||||||||||||||||||||
Net income per common share - Adjusted | |||||||||||||||||||||||||||||||||||||
Basic | $ | 1.05 | $ | 0.79 | $ | 3.86 | $ | 3.10 | |||||||||||||||||||||||||||||
Diluted | $ | 1.01 | $ | 0.76 | $ | 3.71 | $ | 2.98 | |||||||||||||||||||||||||||||
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted 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 adjusted financial measures are non-GAAP and 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. |
Explanation of adjustments: | ||
(1) |
Exclude share-based compensation expense totaling |
|
(2) | Exclude upfront payment expense for research and development collaboration arrangements. | |
(3) | Exclude in-process research and development (IPR&D) impairment recorded as a result of changes in estimated probability-weighted cash flows related to CC-292. | |
(4) | Exclude settlement of a contingent obligation to make matching contributions to a non-profit organization. | |
(5) |
Exclude amortization of intangible assets acquired in the acquisitions of |
|
(6) |
Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, |
|
(7) |
Exclude impairment of royalty receivable asset that was received in |
|
(8) |
Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments, including the effects of acquisition related matters, adjustments to the amount of unrecognized tax benefits, and nonrecurring items connected with the launch of new products. |
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Reconciliation of Full-Year 2015 Projected GAAP to Adjusted Net Income | |||||||||||||||||||||||
(In millions, except per share data) | |||||||||||||||||||||||
Range | |||||||||||||||||||||||
Low | High | ||||||||||||||||||||||
Projected net income - GAAP | (1 | ) | $ | 3,056.7 | $ | 3,256.7 | |||||||||||||||||
Before tax adjustments: | |||||||||||||||||||||||
Cost of goods sold (excluding amortization of acquired | |||||||||||||||||||||||
intangible assets): | |||||||||||||||||||||||
Share-based compensation expense | 36.5 | 34.0 | |||||||||||||||||||||
Research and development: | |||||||||||||||||||||||
Share-based compensation expense | 268.9 | 255.4 | |||||||||||||||||||||
Selling, general and administrative: | |||||||||||||||||||||||
Share-based compensation expense | 304.0 | 292.1 | |||||||||||||||||||||
Amortization of acquired intangible assets | 254.6 | 254.6 | |||||||||||||||||||||
Acquisition related charges, net: | |||||||||||||||||||||||
Change in fair value of contingent consideration | 125.3 | 100.1 | |||||||||||||||||||||
Net income tax adjustments | (228.0 | ) | (250.4 | ) | |||||||||||||||||||
Projected net income - Adjusted | $ | 3,818.0 | $ | 3,942.5 | |||||||||||||||||||
Projected net income per diluted common share - GAAP | $ | 3.68 | $ | 3.92 | |||||||||||||||||||
Projected net income per diluted common share - Adjusted | $ | 4.60 | $ | 4.75 | |||||||||||||||||||
Projected weighted average diluted shares | 830.0 | 830.0 | |||||||||||||||||||||
(1) | Our projected 2015 earnings do not include the effect of any business combinations, collaboration agreements, asset acquisitions, intangible asset impairments, or changes in the fair value of our CVRs issued as part of the acquisition of Abraxis that may occur after the day prior to the date of this press release. | |
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Net Product Sales | |||||||||||||||||||||||||||||||||
(In millions) | |||||||||||||||||||||||||||||||||
Three-Month Periods | |||||||||||||||||||||||||||||||||
Ended |
% Change | ||||||||||||||||||||||||||||||||
2014 | 2013 | Reported | Operational(1) | Currency(2) | |||||||||||||||||||||||||||||
REVLIMID® | |||||||||||||||||||||||||||||||||
U.S. | $ | 797.5 | $ | 663.4 | 20.2% | 20.2% | 0.0% | ||||||||||||||||||||||||||
International | 525.0 | 472.8 | 11.0% | 14.6% | (3.6)% | ||||||||||||||||||||||||||||
Worldwide | 1,322.5 | 1,136.2 | 16.4% | 17.9% | (1.5)% | ||||||||||||||||||||||||||||
ABRAXANE® | |||||||||||||||||||||||||||||||||
U.S. | 171.5 | 159.0 | 7.9% | 7.9% | 0.0% | ||||||||||||||||||||||||||||
International | 64.4 | 42.8 | 50.5% | 52.2% | (1.7)% | ||||||||||||||||||||||||||||
Worldwide | 235.9 | 201.8 | 16.9% | 17.3% | (0.4)% | ||||||||||||||||||||||||||||
POMALYST®/IMNOVID®(3) | |||||||||||||||||||||||||||||||||
U.S. | 131.8 | 89.5 | 47.3% | 47.3% | 0.0% | ||||||||||||||||||||||||||||
International | 70.3 | 31.7 | 121.8% | 124.0% | (2.2)% | ||||||||||||||||||||||||||||
Worldwide | 202.1 | 121.2 | 66.7% | 67.3% | (0.6)% | ||||||||||||||||||||||||||||
VIDAZA® | |||||||||||||||||||||||||||||||||
U.S. | 8.8 | 26.9 | (67.3)% | (67.3)% | 0.0% | ||||||||||||||||||||||||||||
International | 144.9 | 140.6 | 3.1% | 7.0% | (3.9)% | ||||||||||||||||||||||||||||
Worldwide | 153.7 | 167.5 | (8.2)% | (5.0)% | (3.2)% | ||||||||||||||||||||||||||||
azacitidine for injection | |||||||||||||||||||||||||||||||||
U.S. | 15.5 | 23.3 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
International | - | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Worldwide | 15.5 | 23.3 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
THALOMID® | |||||||||||||||||||||||||||||||||
U.S. | 40.7 | 42.4 | (4.0)% | (4.0)% | 0.0% | ||||||||||||||||||||||||||||
International | 16.3 | 18.5 | (11.9)% | (7.5)% | (4.4)% | ||||||||||||||||||||||||||||
Worldwide | 57.0 | 60.9 | (6.4)% | (5.1)% | (1.3)% | ||||||||||||||||||||||||||||
OTEZLA®(4) | |||||||||||||||||||||||||||||||||
U.S. | 47.6 | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
International | - | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Worldwide | 47.6 | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
ISTODAX® | |||||||||||||||||||||||||||||||||
U.S. | 15.9 | 12.8 | 24.2% | 24.2% | 0.0% | ||||||||||||||||||||||||||||
International | 0.8 | 0.8 | 0.0% | 2.0% | (2.0)% | ||||||||||||||||||||||||||||
Worldwide | 16.7 | 13.6 | 22.8% | 22.9% | (0.1)% | ||||||||||||||||||||||||||||
All Other | |||||||||||||||||||||||||||||||||
U.S. | 3.2 | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
International | 0.7 | 0.4 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Worldwide | 3.9 | 0.4 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Total Net Product Sales | |||||||||||||||||||||||||||||||||
U.S. | 1,232.5 | 1,017.3 | 21.2% | 21.2% | 0.0% | ||||||||||||||||||||||||||||
International | 822.4 | 707.6 | 16.2% | 19.7% | (3.5)% | ||||||||||||||||||||||||||||
Worldwide | $ | 2,054.9 | $ | 1,724.9 | 19.1% | 20.5% | (1.4)% | ||||||||||||||||||||||||||
(1) | - Operational includes impact from both volume and price | |
(2) | - Currency includes the impact from both foreign exchange rates and hedging activities | |
(3) |
- POMALYST® was approved in the U.S. on |
|
(4) |
- OTEZLA® was approved in the U.S. for Psoriatic Arthritis on |
|
|
|||||||||||||||||||||||||||||||||
Net Product Sales | |||||||||||||||||||||||||||||||||
(In millions) | |||||||||||||||||||||||||||||||||
Twelve-Month Periods | |||||||||||||||||||||||||||||||||
Ended |
% Change | ||||||||||||||||||||||||||||||||
2014 | 2013 | Reported | Operational(1) | Currency(2) | |||||||||||||||||||||||||||||
REVLIMID® | |||||||||||||||||||||||||||||||||
U.S. | $ | 2,915.7 | $ | 2,488.7 | 17.2% | 17.2% | 0.0% | ||||||||||||||||||||||||||
International | 2,064.3 | 1,791.6 | 15.2% | 15.6% | (0.4)% | ||||||||||||||||||||||||||||
Worldwide | 4,980.0 | 4,280.3 | 16.3% | 16.4% | (0.1)% | ||||||||||||||||||||||||||||
ABRAXANE® | |||||||||||||||||||||||||||||||||
U.S. | 624.5 | 504.7 | 23.7% | 23.7% | 0.0% | ||||||||||||||||||||||||||||
International | 223.7 | 144.2 | 55.1% | 55.1% | 0.0% | ||||||||||||||||||||||||||||
Worldwide | 848.2 | 648.9 | 30.7% | 30.7% | 0.0% | ||||||||||||||||||||||||||||
POMALYST®/IMNOVID®(3) | |||||||||||||||||||||||||||||||||
U.S. | 443.0 | 246.0 | 80.1% | 80.1% | 0.0% | ||||||||||||||||||||||||||||
International | 236.7 | 59.4 | 298.5% | 302.7% | (4.2)% | ||||||||||||||||||||||||||||
Worldwide | 679.7 | 305.4 | 122.6% | 123.4% | (0.8)% | ||||||||||||||||||||||||||||
VIDAZA® | |||||||||||||||||||||||||||||||||
U.S. | 42.8 | 275.5 | (84.5)% | (84.5)% | 0.0% | ||||||||||||||||||||||||||||
International | 569.1 | 527.8 | 7.8% | 8.4% | (0.6)% | ||||||||||||||||||||||||||||
Worldwide | 611.9 | 803.3 | (23.8)% | (23.4)% | (0.4)% | ||||||||||||||||||||||||||||
azacitidine for injection | |||||||||||||||||||||||||||||||||
U.S. | 78.2 | 23.3 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
International | - | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Worldwide | 78.2 | 23.3 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
THALOMID® | |||||||||||||||||||||||||||||||||
U.S. | 152.6 | 166.9 | (8.6)% | (8.6)% | 0.0% | ||||||||||||||||||||||||||||
International | 68.6 | 77.6 | (11.6)% | (11.1)% | (0.5)% | ||||||||||||||||||||||||||||
Worldwide | 221.2 | 244.5 | (9.5)% | (9.3)% | (0.2)% | ||||||||||||||||||||||||||||
OTEZLA®(4) | |||||||||||||||||||||||||||||||||
U.S. | 69.8 | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
International | - | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Worldwide | 69.8 | - | N/A | N/A | N/A | ||||||||||||||||||||||||||||
ISTODAX® | |||||||||||||||||||||||||||||||||
U.S. | 61.4 | 49.9 | 23.0% | 23.0% | 0.0% | ||||||||||||||||||||||||||||
International | 4.2 | 4.1 | 2.4% | 0.3% | 2.1% | ||||||||||||||||||||||||||||
Worldwide | 65.6 | 54.0 | 21.5% | 21.3% | 0.2% | ||||||||||||||||||||||||||||
All Other | |||||||||||||||||||||||||||||||||
U.S. | 6.7 | 0.4 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
International | 2.5 | 2.2 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Worldwide | 9.2 | 2.6 | N/A | N/A | N/A | ||||||||||||||||||||||||||||
Total Net Product Sales | |||||||||||||||||||||||||||||||||
U.S. | 4,394.7 | 3,755.4 | 17.0% | 17.0% | 0.0% | ||||||||||||||||||||||||||||
International | 3,169.1 | 2,606.9 | 21.6% | 22.1% | (0.5)% | ||||||||||||||||||||||||||||
Worldwide | $ | 7,563.8 | $ | 6,362.3 | 18.9% | 19.1% | (0.2)% | ||||||||||||||||||||||||||
(1) | - Operational includes impact from both volume and price | |
(2) | - Currency includes the impact from both foreign exchange rates and hedging activities | |
(3) |
- POMALYST® was approved in the U.S. on |
|
(4) |
- OTEZLA® was approved in the U.S. for Psoriatic Arthritis on |
|
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