- Data from at Least 18 Phase III Trials Expected from Mid-2016 Through Mid-2018
-
2016 Guidance for Total Net Product Sales, REVLIMID®
Net Sales and Diluted EPS
Net product sales for the full year of 2015 were
Based on
"Celgene delivered outstanding operating and financial results in 2015. Our extraordinary operating momentum and key regulatory approvals in 2015 increase our prospects for significant growth in 2016 and beyond," said
Fourth Quarter and Full Year 2015 Financial Highlights
Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2015 compared to the fourth quarter and full year of 2014. 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. Please see the attached Reconciliation of GAAP to Adjusted Net Income for further information.
Net Product Sales Performance
-
REVLIMID® sales for the fourth quarter increased 18 percent to
$1,561 million and were driven by increased duration of therapy in theU.S. and market share gains in newly diagnosed multiple myeloma (NDMM) inEurope . Fourth quarterU.S. sales of$956 million and international sales of$605 million increased 20 percent and 15 percent, respectively. Full year REVLIMID® sales were$5,801 million , an increase of 16 percent. -
POMALYST®/IMNOVID® sales for the fourth quarter were
$294 million . Fourth quarterU.S. sales of$170 million and international sales of$124 million increased 29 percent and 77 percent, respectively. Full year POMALYST®/IMNOVID® sales were$983 million . Sales were driven by increased market share and duration gains. -
ABRAXANE® sales for the fourth quarter were
$270 million , an increase of 14 percent.U.S. sales were$180 million and international sales were$90 million , an increase of 5 percent and 41 percent, respectively. Full year ABRAXANE® sales were$967 million , an increase of 14 percent. -
OTEZLA® sales in the fourth quarter were
$183 million . Full year OTEZLA® sales were$472 million . OTEZLA® uptake and market share gains continued to accelerate in the fourth quarter in theU.S. with increased contribution from early launch countries inEurope . -
In the fourth quarter, all other product sales, which include THALOMID®, ISTODAX®, VIDAZA® and an authorized generic version of VIDAZA®drug product in the
U.S. , were$231 million compared to$248 million in the fourth quarter of 2014. Full year sales for these products were$938 million .
Research and Development (R&D)
Adjusted R&D expenses were
For the full year of 2015, 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/Oncology
In
In December, REVLIMID® was granted full marketing authorization by
At the 57th
Subsequent to our
Data on the combination of ABRAXANE® with chemotherapy and with anti-PD-L1 compounds in neoadjuvant and triple-negative breast cancer were presented at the San Antonio Breast Cancer Symposium in December. Data from the phase III
Inflammation & Immunology
In
Results from the two phase III ESTEEM trials (ESTEEM 1 and ESTEEM 2) in patients with psoriasis were published in the Journal of the American Academy of Dermatology. At week 16, OTEZLA® produced greater NAPSI-50 response (50% reduction from baseline in target Nail Psoriasis Severity Index score) versus placebo (both studies P < .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P < .0001). Improvements were generally maintained over 52 weeks in patients with Psoriasis Area and Severity Index response at week 32.
Three year efficacy and safety data of OTEZLA® in patients with psoriatic arthritis from the phase III PALACE 1 trial were presented at the
In the fourth quarter, a large phase III pivotal trial with GED-0301 in active Crohn's disease began enrollment. In addition, a phase II trial with GED-0301 in ulcerative colitis also began enrollment. Data from the registration-enabling endoscopic trial with GED-0301 is expected in 2017. Also in the quarter, the phase II STEPSTONE trial with ozanimod in Crohn's disease began enrollment.
Business Update
Data from at Least 18 Phase III Trials Expected from Mid-2016 Through Mid-2018
2016
- REMARC trial with REVLIMID® in DLBCL maintenance
- CONTINUUM® trial with REVLIMID® in CLL maintenance
-
ETNA trial with ABRAXANE® in neoadjuvant breast cancer - PSA-006 trial with OTEZLA® in biologic naïve psoriatic arthritis
2017
- RELEVANCE® trial with REVLIMID® in first-line follicular lymphoma
- AUGMENT® trial with REVLIMID® in relapsed and/or refractory follicular lymphoma
- IMpower 130 Roche-sponsored trial with ABRAXANE® and atezolizumab in non-squamous non-small cell lung cancer (NSCLC)
- IMpower 131 Roche-sponsored trial with ABRAXANE® and atezolizumab in squamous NSCLC
- apact® trial with ABRAXANE® in adjuvant pancreatic cancer
- abound®.sqm with ABRAXANE® in squamous NSCLC maintenance
- RELIEFTM trial with OTEZLA® in Behçet's disease
- SUNBEAM trial with ozanimod in multiple sclerosis
- RADIANCE trial with ozanimod in multiple sclerosis
2018
- OPTIMISMM® trial with POMALYST® in second-line relapsed and/or refractory multiple myeloma
- IMpassion 130 Roche-sponsored trial with ABRAXANE® and atezolizumab in triple-negative breast cancer
- CD-002 trial with GED-0301 in Crohn's disease
- CD-003 trial with GED-0301 in Crohn's disease
- TRUE NORTH trial with ozanimod in ulcerative colitis
Celgene Expects Strong Product Sales and Earnings Growth in 2016
-
Total net product sales of
$10.5 billion to$11.0 billion , an increase of 17 percent year-over-year based on the mid-point of the range and includes a negative impact from foreign exchange of approximately$120 million -
REVLIMID® net sales in the range of
$6.6 billion to$6.7 billion , an increase of 15 percent year-over-year based on the mid-point of the range - Adjusted operating margin of approximately 53.5 percent after investments across the entire organization, a 150 bps improvement over 2015. GAAP operating margin is expected to be approximately 42 percent
-
Adjusted diluted EPS in the range of
$5.50 to$5.70 , an increase of approximately 19 percent year-over-year based on the mid-point of the range. GAAP diluted EPS is expected to be in the range of$4.26 to$4.64 - Fully diluted share count for the full-year 2016 of approximately 825 million
-
For the first quarter of 2016, adjusted diluted EPS in the range of
$1.27 to$1.30 . GAAP diluted EPS is expected to be in the range of$0.98 to$1.05
Please see the attached Reconciliations of 2016 Projected GAAP to Adjusted Net Income for further information.
Q4 and Full year 2015 Conference Call and Webcast Information
About
About REVLIMID®
In the
About ABRAXANE®
In the
About POMALYST®
In the
About OTEZLA®
In the
About VIDAZA®
In the
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
|
||||||||||||
Three-Month Periods Ended |
Twelve-Month Periods Ended | |||||||||||
|
|
|||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||
Net product sales | $ | 2,539.2 | $ | 2,054.9 | $ | 9,161.1 | $ | 7,563.8 | ||||
Other revenue | 24.1 | 30.6 | 94.9 | 106.6 | ||||||||
Total revenue | 2,563.3 | 2,085.5 | 9,256.0 | 7,670.4 | ||||||||
Cost of goods sold (excluding amortization of | ||||||||||||
acquired intangible assets) | 105.4 | 103.2 | 420.1 | 385.9 | ||||||||
Research and development | 776.8 | 584.9 | 3,697.3 | 2,430.6 | ||||||||
Selling, general and administrative | 609.1 | 544.4 | 2,305.4 | 2,027.9 | ||||||||
Amortization of acquired intangible assets | 88.1 | 63.6 | 279.0 | 258.3 | ||||||||
Acquisition related charges and restructuring, net | 83.7 | 37.7 | 299.6 | 48.7 | ||||||||
Total costs and expenses | 1,663.1 | 1,333.8 | 7,001.4 | 5,151.4 | ||||||||
Operating income | 900.2 | 751.7 | 2,254.6 | 2,519.0 | ||||||||
Interest and investment income, net | 4.7 | 7.6 | 31.1 | 28.2 | ||||||||
Interest (expense) | (124.6) | (51.7) | (310.6) | (176.1) | ||||||||
Other income (expense), net | (34.8) | 3.2 | 48.4 | (43.7) | ||||||||
Income before income taxes | 745.5 | 710.8 | 2,023.5 | 2,327.4 | ||||||||
Income tax provision | 184.5 | 96.9 | 421.5 | 327.5 | ||||||||
Net income | $ | 561.0 | $ | 613.9 | $ | 1,602.0 | $ | 1,999.9 | ||||
Net income per common share: | ||||||||||||
Basic | $ | 0.71 | $ | 0.77 | $ | 2.02 | $ | 2.49 | ||||
Diluted | $ | 0.69 | $ | 0.74 | $ | 1.94 | $ | 2.39 | ||||
Weighted average shares: | ||||||||||||
Basic | 785.8 | 800.2 | 792.2 | 802.7 | ||||||||
Diluted | 816.5 | 834.6 | 824.9 | 836.0 | ||||||||
|
|
|||||||||||
2015 | 2014 | |||||||||||
Balance sheet items: | ||||||||||||
Cash, cash equivalents & marketable securities | $ | 6,551.9 | $ | 7,546.7 | ||||||||
Total assets | 27,053.4 | 17,340.1 | ||||||||||
Short-term borrowings and current portion of long-term debt | - | 605.9 | ||||||||||
Long-term debt | 14,250.4 | 6,265.7 | ||||||||||
Total stockholders' equity | 5,919.0 | 6,524.8 | ||||||||||
|
||||||||||||||
Three-Month Periods Ended | Twelve-Month Periods Ended | |||||||||||||
|
|
|||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||
Net income - GAAP | $ | 561.0 | $ | 613.9 | $ | 1,602.0 | $ | 1,999.9 | ||||||
Before tax adjustments: | ||||||||||||||
Cost of goods sold (excluding amortization | ||||||||||||||
of acquired intangible assets): | ||||||||||||||
Share-based compensation expense | (1) | 8.4 | 7.4 | 31.7 | 26.2 | |||||||||
Research and development: | ||||||||||||||
Share-based compensation expense | (1) | 65.7 | 55.3 | 250.7 | 196.5 | |||||||||
Upfront collaboration expense | (2) | 62.0 | 52.0 | 1,402.3 | 453.6 | |||||||||
IPR&D impairment | (3) | - | - | - | 129.2 | |||||||||
Selling, general and administrative: | ||||||||||||||
Share-based compensation expense | (1) | 76.1 | 65.7 | 294.2 | 224.9 | |||||||||
Settlement of contingent obligation | (4) | - | - | - | 25.0 | |||||||||
Amortization of acquired intangible assets | (5) | 88.1 | 63.6 | 279.0 | 258.3 | |||||||||
Acquisition related (gains) charges and restructuring, net: | ||||||||||||||
Change in fair value of contingent consideration | (6) | 9.3 | 37.7 | (7.9) | 48.7 | |||||||||
Acquisition costs | (7) | 66.0 | - | 297.6 | - | |||||||||
Restructuring charges | (8) | 8.4 | - | 9.9 | - | |||||||||
Net income tax adjustments | (9) | 16.4 | (55.4) | (277.1) | (263.7) | |||||||||
Net income - Adjusted | $ | 961.4 | $ | 840.2 | $ | 3,882.4 | $ | 3,098.6 | ||||||
Net income per common share - Adjusted | ||||||||||||||
Basic | $ | 1.22 | $ | 1.05 | $ | 4.90 | $ | 3.86 | ||||||
Diluted | $ | 1.18 | $ | 1.01 | $ | 4.71 | $ | 3.71 | ||||||
In addition to financial information prepared in accordance with
Explanation of adjustments: | |||
(1) |
Exclude share-based compensation expense totaling |
||
period ended |
|||
and |
|||
(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, |
||
Quanticel. | |||
(7) |
Exclude equity compensation and other fees and costs related to the acquisitions of |
||
(8) |
Exclude restructuring charges related to our relocation of certain operations into our two |
||
with certain headcount reductions. | |||
(9) | 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, adjustments related to the gain on the | |||
sale of an equity investment and nonrecurring items connected with the launch of new products. | |||
|
||||||||||||||
Three-Month Period Ending | Twelve-Month Period Ending | |||||||||||||
|
|
|||||||||||||
Low | High | Low | High | |||||||||||
Projected net income - GAAP | (1) | $ | 804.5 | $ | 859.9 | $ | 3,517.8 | $ | 3,827.7 | |||||
Before tax adjustments: | ||||||||||||||
Cost of goods sold (excluding amortization of acquired intangible assets): | ||||||||||||||
Share-based compensation expense | 8.1 | 7.9 | 38.7 | 36.8 | ||||||||||
|
||||||||||||||
Share-based compensation expense | 64.6 | 63.4 | 307.5 | 292.1 | ||||||||||
Selling, general and administrative: | ||||||||||||||
Share-based compensation expense | 76.3 | 74.7 | 362.6 | 344.5 | ||||||||||
Amortization of acquired intangible assets | 97.1 | 88.7 | 388.4 | 354.8 | ||||||||||
Acquisition related charges and restructuring, net: | ||||||||||||||
Change in fair value of contingent consideration | 37.2 | 33.6 | 136.3 | 123.3 | ||||||||||
Restructuring charges | 10.0 | 5.0 | 30.0 | 15.0 | ||||||||||
Net income tax adjustments | (56.4) | (67.2) | (243.8) | (291.7) | ||||||||||
Projected net income - Adjusted | $ | 1,041.4 | $ | 1,066.0 | $ | 4,537.5 | $ | 4,702.5 | ||||||
Projected net income per diluted common share - GAAP | $ | 0.98 | $ | 1.05 | $ | 4.26 | $ | 4.64 | ||||||
Projected net income per diluted common share - Adjusted | $ | 1.27 | $ | 1.30 | $ | 5.50 | $ | 5.70 | ||||||
Projected weighted average diluted shares | 820.0 | 820.0 | 825.0 | 825.0 | ||||||||||
(1) | Our projected 2016 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. | |
|
||||||||||||
Three-Month Periods | ||||||||||||
Ended |
% Change | |||||||||||
2015 | 2014 | Reported | Operational(1) | Currency(2) | ||||||||
REVLIMID® | ||||||||||||
|
$ | 956.3 | $ | 797.5 | 19.9% | 19.9% | 0.0% | |||||
International | 604.4 | 525.0 | 15.1% | 18.1% | (3.0)% | |||||||
Worldwide | 1,560.7 | 1,322.5 | 18.0% | 19.2% | (1.2)% | |||||||
ABRAXANE® | ||||||||||||
|
179.5 | 171.5 | 4.7% | 4.7% | 0.0% | |||||||
International | 90.5 | 64.4 | 40.5% | 39.5% | 1.0% | |||||||
Worldwide | 270.0 | 235.9 | 14.5% | 14.2% | 0.3% | |||||||
POMALYST®/IMNOVID® | ||||||||||||
|
169.7 | 131.8 | 28.8% | 28.8% | 0.0% | |||||||
International | 124.1 | 70.3 | 76.5% | 72.2% | 4.3% | |||||||
Worldwide | 293.8 | 202.1 | 45.4% | 43.9% | 1.5% | |||||||
OTEZLA®(3) | ||||||||||||
|
167.5 | 47.6 | N/A | N/A | N/A | |||||||
International | 15.5 | - | N/A | N/A | N/A | |||||||
Worldwide | 183.0 | 47.6 | N/A | N/A | N/A | |||||||
VIDAZA® | ||||||||||||
|
4.8 | 8.8 | (45.5)% | (45.5)% | 0.0% | |||||||
International | 142.6 | 144.9 | (1.6)% | 1.5% | (3.1)% | |||||||
Worldwide | 147.4 | 153.7 | (4.1)% | (1.2)% | (2.9)% | |||||||
azacitidine for injection | ||||||||||||
|
19.7 | 15.5 | 27.1% | 27.1% | 0.0% | |||||||
International | - | - | N/A | N/A | N/A | |||||||
Worldwide | 19.7 | 15.5 | 27.1% | 27.1% | 0.0% | |||||||
THALOMID® | ||||||||||||
|
31.5 | 40.7 | (22.6)% | (22.6)% | 0.0% | |||||||
International | 14.0 | 16.3 | (14.1)% | (9.1)% | (5.0)% | |||||||
Worldwide | 45.5 | 57.0 | (20.2)% | (18.8)% | (1.4)% | |||||||
ISTODAX® | ||||||||||||
|
16.1 | 15.9 | 1.3% | 1.3% | 0.0% | |||||||
International | 1.3 | 0.8 | 62.5% | 66.9% | (4.4)% | |||||||
Worldwide | 17.4 | 16.7 | 4.2% | 4.4% | (0.2)% | |||||||
All Other | ||||||||||||
|
1.0 | 3.2 | N/A | N/A | N/A | |||||||
International | 0.7 | 0.7 | N/A | N/A | N/A | |||||||
Worldwide | 1.7 | 3.9 | N/A | N/A | N/A | |||||||
Total Net Product Sales | ||||||||||||
|
1,546.1 | 1,232.5 | 25.4% | 25.4% | 0.0% | |||||||
International | 993.1 | 822.4 | 20.8% | 22.8% | (2.0)% | |||||||
Worldwide | $ | 2,539.2 | $ | 2,054.9 | 23.6% | 24.4% | (0.8)% | |||||
(1) |
- Operational includes impact from both volume and price
|
|
(2) |
- Currency includes the impact from both foreign exchange rates and hedging activities
|
|
(3) |
- OTEZLA® was approved in the
|
|
|
||||||||||||
Twelve-Month Periods | ||||||||||||
Ended |
% Change | |||||||||||
2015 | 2014 | Reported | Operational(1) | Currency(2) | ||||||||
REVLIMID® | ||||||||||||
|
$ | 3,534.9 | $ | 2,915.7 | 21.2% | 21.2% | 0.0% | |||||
International | 2,266.2 | 2,064.3 | 9.8% | 14.2% | (4.4)% | |||||||
Worldwide | 5,801.1 | 4,980.0 | 16.5% | 18.3% | (1.8)% | |||||||
ABRAXANE® | ||||||||||||
|
653.6 | 624.5 | 4.7% | 4.7% | 0.0% | |||||||
International | 313.9 | 223.7 | 40.3% | 39.5% | 0.8% | |||||||
Worldwide | 967.5 | 848.2 | 14.1% | 13.9% | 0.2% | |||||||
POMALYST®/IMNOVID® | ||||||||||||
|
591.8 | 443.0 | 33.6% | 33.6% | 0.0% | |||||||
International | 391.5 | 236.7 | 65.4% | 62.8% | 2.6% | |||||||
Worldwide | 983.3 | 679.7 | 44.7% | 43.8% | 0.9% | |||||||
OTEZLA®(3) | ||||||||||||
|
440.0 | 69.8 | N/A | N/A | N/A | |||||||
International | 31.7 | - | N/A | N/A | N/A | |||||||
Worldwide | 471.7 | 69.8 | N/A | N/A | N/A | |||||||
VIDAZA® | ||||||||||||
|
21.2 | 42.8 | (50.5)% | (50.5)% | 0.0% | |||||||
International | 569.5 | 569.1 | 0.1% | 4.4% | (4.3)% | |||||||
Worldwide | 590.7 | 611.9 | (3.5)% | 0.5% | (4.0)% | |||||||
azacitidine for injection | ||||||||||||
|
83.9 | 78.2 | 7.3% | 7.3% | 0.0% | |||||||
International | - | - | N/A | N/A | N/A | |||||||
Worldwide | 83.9 | 78.2 | 7.3% | 7.3% | 0.0% | |||||||
THALOMID® | ||||||||||||
|
129.0 | 152.6 | (15.5)% | (15.5)% | 0.0% | |||||||
International | 56.4 | 68.6 | (17.8)% | (11.1)% | (6.7)% | |||||||
Worldwide | 185.4 | 221.2 | (16.2)% | (14.1)% | (2.1)% | |||||||
ISTODAX® | ||||||||||||
|
64.5 | 61.4 | 5.0% | 5.0% | 0.0% | |||||||
International | 4.6 | 4.2 | 9.5% | 14.9% | (5.4)% | |||||||
Worldwide | 69.1 | 65.6 | 5.3% | 5.7% | (0.4)% | |||||||
All Other | ||||||||||||
|
5.7 | 6.7 | N/A | N/A | N/A | |||||||
International | 2.7 | 2.5 | N/A | N/A | N/A | |||||||
Worldwide | 8.4 | 9.2 | N/A | N/A | N/A | |||||||
Total Net Product Sales | ||||||||||||
|
5,524.6 | 4,394.7 | 25.7% | 25.7% | 0.0% | |||||||
International | 3,636.5 | 3,169.1 | 14.7% | 18.2% | (3.5)% | |||||||
Worldwide | $ | 9,161.1 | $ | 7,563.8 | 21.1% | 22.5% | (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) |
- OTEZLA® was approved in the
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160128005651/en/
Investors:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President
Investor Relations
or
Media:
Vice President
Corporate Communications
Source:
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