Genzyme Corp. (NASDAQ: GENZ) today reported fourth-quarter 2010
results that reflect increasing supplies of Cerezyme® (imiglucerase
for injection) and Fabrazyme® (agalsidase beta), revenue growth
across all major product lines, and reductions in operating
expenses. Earlier today Genzyme and sanofi-aventis announced that
they have reached a definitive agreement under which sanofi-aventis
will acquire Genzyme for $74 per share plus a contingent value
right. This news is covered in a separate press release.
Fourth-quarter GAAP net income was $471.9 million, or $1.76 per
diluted share, compared with $23.2 million, or $0.09 per diluted
share, in the same period in 2009. Non-GAAP net income was $221.1
million, or $0.82 per diluted share, compared with $78.1 million,
or $0.29 per diluted share, in the fourth quarter of 2009. Non-GAAP
2010 income excludes items associated with business divestitures,
Bayer oncology product acquisition expenses, and stock compensation
expenses.
Full-year 2010 GAAP net income was $422.1 million, or $1.57 per
diluted share, compared with $422.3 million, or $1.54 per diluted
share, in 2009. Non-GAAP net income was $478.5 million, or $1.78
per diluted share, compared with $611.5 million, or $2.23 per
diluted share, in 2009. Genzyme exited 2010 with $1.9 billion in
cash and equivalents.
Fourth-quarter GAAP revenue grew 23 percent to $1.15 billion
from $938.3 million in the fourth quarter of 2009; non-GAAP revenue
was $1.13 billion. For the year, GAAP revenue was $4.05 billion
compared with $3.98 billion in 2009; non-GAAP revenue was $4.03
billion. Non-GAAP revenue figures exclude the pharmaceuticals and
cell therapy businesses, which Genzyme intends to divest.
“Strong growth in the fourth quarter demonstrates that our
recovery is fully underway,” said Henri A. Termeer, Genzyme’s
chairman and CEO. “By executing on the opportunities provided by
our core businesses and reducing our operating expenses, we were
able to nearly double our earnings from the third quarter to the
fourth.”
Genzyme expects to achieve several important manufacturing and
product-related milestones during 2011, including:
- Ceasing the remaining fill/finish
activities at the Allston facility for all products and
transferring those operations to a contract manufacturer during the
first half of the year;
- Announcing top-line data from the first
phase 3 trial of alemtuzumab for multiple sclerosis mid-year and
from the second trial in the second half of the year;
- Fully supplying existing patient demand
for Fabrazyme and receiving approval for its production at the new
Framingham plant, both expected during the second half of 2011;
and
- Maintaining the existing full supply of
Cerezyme.
The company is continuing to make progress in implementing its
plan to increase shareholder value, which includes the divestitures
of non-core businesses. In the fourth quarter, Genzyme completed
the sale of its Genetics business, and the company this quarter
completed the sale of its Diagnostics business and entered into an
agreement to sell its Pharmaceuticals business.
As part of the company’s initiative to improve its operating
margins, Genzyme last year implemented a program focused on
identifying sustainable cost savings opportunities across the
organization. This resulted in $26 million in savings during the
fourth quarter and is expected to create $275 million in savings in
2011.
Along with the expected 2011 milestones, Genzyme expects that
supply recovery, business growth and the company’s late-stage
pipeline will serve as growth drivers this year.
Supply Recovery of Cerezyme and
Fabrazyme
The recovery of Cerezyme supply is on track, with currently
treated patients back to full supply and bioreactor performance at
the higher end of historical experience. Fabrazyme supply is
improving and allocations increased 82 percent from the third
quarter to the fourth.
Genzyme is ahead of schedule in its plans to expand its
biologics and fill/finish manufacturing capacity. Fabrazyme process
validation runs at the company’s new Framingham manufacturing
facility have begun, and the material created through these runs
will become commercial product inventory upon regulatory approval
of Fabrazyme production at this facility. This approval is expected
during the second half of this year and will enable the company to
provide full, sustainable product supply.
During the fourth quarter, Genzyme ceased fill/finish operations
at its Allston facility for products sold in the United States, and
the company plans to transfer the remaining fill/finish operations
to a contract manufacturer during the first half of this year. An
expansion of fill/finish operations at the Waterford site creating
a four-fold capacity increase is expected to be approved in late
2011.
Business Unit Revenue
Growth
Record revenue in the fourth quarter shows strength across each
of Genzyme’s businesses. In 2011, the company expects double-digit
revenue growth, driven primarily by Cerezyme and Fabrazyme. In
addition, Genzyme expects strong growth from its Pompe disease
treatments Myozyme® (alglucosidase alfa) and Lumizyme®
(alglucosidase alfa); its viscosupplement treatments Synvisc®
(hylan G-F 20) and Synvisc-One® (hylan G-F 20); and its Hematology
and Oncology business.
Personalized Genetic Health
Fourth-quarter revenue from the Personalized Genetic Health
business grew 45 percent to $505.6 million from $348.0 million in
same period in 2009, and 25 percent from $404.2 million in the
third quarter of 2010. This growth reflects increasing supplies of
Cerezyme and Fabrazyme, and the U.S. launch of Lumizyme.
The company’s Pompe disease treatments represent an opportunity
that is comparable to that of Cerezyme for Gaucher disease. The
company estimates that there are about 10,000 Pompe patients
worldwide; approximately 1,400 Pompe patients are currently treated
with either Myozyme or Lumizyme, which are the only treatments
approved for the disease.
Fourth-quarter revenue of Myozyme/Lumizyme grew 39 percent to
$127.5 million compared with $91.9 million in the same period in
2009. Full-year sales increased 27 percent to $411.8 million
compared with $324.5 million in 2009. Increases in both
fourth-quarter and full-year revenue reflect, in part, sales of
Lumizyme following FDA approval in May 2010. U.S. sales of
Myozyme/Lumizyme in the fourth quarter were $30.3 million. Myozyme
is currently available in 48 markets worldwide and Genzyme expects
to increase this to 60 markets by the end of this year.
Fourth-quarter sales of Cerezyme were $222.0 million compared
with $105.4 million in the same period in 2009, and full-year sales
were $719.6 million compared with $793.0 million in 2009. Genzyme
recently won a six-month tender for Cerezyme in Brazil that covers
the first half of 2011. Sales of Fabrazyme in the fourth quarter
were $61.6 million compared with $58.0 million in the fourth
quarter of 2009; full-year sales were $188.2 million compared with
$429.7 million in 2009.
Biosurgery
GAAP revenue from Genzyme’s Biosurgery business grew to $628.8
million in 2010 from $561.8 million in 2009, driven by its
viscosupplement treatments Synvisc and Synvisc-One. Non-GAAP 2010
revenue was $615.8 million. GAAP fourth-quarter 2010 revenue was
$170.7 million compared with $157.3 million in the same period in
2009; non-GAAP revenue was $157.7 million. Non-GAAP revenue figures
exclude the cell therapy business, which Genzyme intends to
divest.
Synvisc-One, which was launched in the first quarter of 2009, is
the only single-injection viscosupplement approved for the
treatment of osteoarthritis (OA) knee pain in the United States, a
market that is large, growing and under-penetrated. The percentage
of the approximately 9 million eligible OA patients in the United
States who are currently treated with viscosupplements grew last
year from 14 to 16 percent.
Fourth-quarter sales of Synvisc and Synvisc-One grew 11 percent
to $105.9 million compared with $95.4 million in the fourth quarter
of 2009, and full-year sales increased 19 percent to $393.1 million
compared with $328.5 million in 2009. Genzyme in the fourth quarter
received approval of Synvisc in Japan, the largest market in the
world for viscosupplements.
Hematology and Oncology
Full-year revenue from Genzyme’s Hematology and Oncology
business grew 32 percent to $678.8 million in 2010 from $512.9 in
2009, primarily driven by the ongoing launch of Mozobil®
(plerixafor injection), the significant growth of Clolar®
(clofarabine) in the U.S. and Europe and a full year of sales for
the products acquired from Bayer. Fourth quarter revenue was $178.7
million compared with $168.8 million in the same period in
2009.
In 2011, Genzyme expects growth in this business to be driven
primarily by Mozobil, Thymoglobulin® (anti-thymocyte globulin
(rabbit)) and Clolar through increased penetration in key segments
of the U.S. and mature European markets, and expansion in emerging
markets such as China. During the second half of this year, the
company expects data from a clinical trial of Clolar in adult
patients with acute myelogenous leukemia, which if positive could
potentially support regulatory filings for an expanded indication
for the product.
Renal and Endocrinology
The company’s Renal and Endocrinology business performed
extremely well in the fourth quarter, delivering 12 percent growth
with revenue of $288.9 million compared with $258.2 million in the
fourth quarter of 2009. This was driven by strong Renvela®
(sevelamer carbonate) performance in the United States, where it
remains the market leading phosphate binder; the launch of Renvela
in major EU markets including France and Italy; and the new tender
in Brazil. Full-year 2010 revenue from the business was $1.07
billion, compared with $1.01 billion in 2009.
Genzyme recently completed a pivotal study of Renvela in Chinese
patients with chronic kidney disease (CKD) on dialysis. The study
met its primary endpoint, and the company anticipates filing for
approval of Renvela’s use in treating hyperphosphatemic dialysis
patients in China during the first half of 2011. The company
expects sustainable growth of Renvela in 2011 as it continues to
launch the product in Europe, where the company has marketing
approval for the product’s use in hyperphosphatemic CKD patients
who are on dialysis, and in those who are not on dialysis.
Promising Late-Stage
Pipeline
Within Genzyme’s late-stage product pipeline, three approvals
are expected by the end of 2013: alemtuzumab for multiple
sclerosis, mipomersen for familial hypercholesterolemia, and
eliglustat tartrate for Gaucher disease type 1.
- Based on promising phase 2 data,
alemtuzumab has the potential to become a new standard of care for
multiple sclerosis treatment, a market that is expected to reach
$13 billion by 2012. Two phase 3 trials are fully enrolled; results
of the trial in treatment-naïve patients are expected mid-year, and
results of the trial in treatment-experienced patients are expected
during the second half of this year. Genzyme anticipates U.S.
approval of the treatment in the second half of 2012.
- Genzyme is partnering with Isis
Pharmaceuticals Inc. on the development of mipomersen for familial
hypercholesterolemia (FH) patients who are unable to achieve
healthy LDL-cholesterol levels with current treatments. The
companies have completed four phase 3 trials of the novel
treatment, all of which met their primary endpoints. Genzyme plans
to file for EU approval of the treatment for patients with
homozygous FH (HoFH) in the first half of this year. This filing
may also include severe heterozygous FH (HeFH). Following recent
FDA feedback, Genzyme is determining the timing of the U.S. HoFH
filing, which may shift to the second half of this year.
- Three-year follow-up data from the
phase 2 study of eliglustat tartrate, Genzyme’s investigational
oral therapy for patients with Gaucher disease type 1, will be
presented this week at the Lysosomal Disease Network WORLD
Symposium. At the three-year timepoint, sustained or further
improvements were observed across all endpoints, including bone
disease, compared with baseline. Eliglustat tartrate, which is
currently in phase 3 trials, has the potential to transform the
treatment experience for patients with Gaucher disease by providing
an oral capsule option instead of bi-weekly infusions.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people
with serious diseases. Since 1981, the company has grown from a
small start-up to a diversified enterprise with approximately
10,000 employees in locations spanning the globe.
With many established products and services helping patients in
approximately 100 countries, Genzyme is a leader in the effort to
develop and apply the most advanced technologies in the life
sciences. The company's products and services are focused on rare
inherited disorders, kidney disease, orthopaedics, cancer,
transplant and immune disease. Genzyme's commitment to innovation
continues today with a substantial development program focused on
these fields, as well as cardiovascular disease, neurodegenerative
diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are
available at www.genzyme.com and by calling Genzyme’s investor
information line at 1-800-905-4369 within the United States or
1-678-999-4572 outside the United States.
This press release contains forwarding-looking statements
regarding Genzyme’s financial results and outlook and business
plans and strategies including, without limitation: expectations
regarding revenue growth; the expected completion and timing of
ceasing fill/finish operations at the Allston facility and the
transfer of those operations; the anticipated receipt and timing of
alemtuzumab clinical trial data results; expectations regarding
Fabrazyme supply and meeting patient demand; expectations regarding
the timing and results of validation runs at, and receipt and
timing of regulatory approval of, the new Framingham facility;
expectations regarding the supply of Cerezyme; the expected receipt
and timing of regulatory approval of the expanded fill/finish
operations at the Waterford facility; expectations regarding
Myozyme/Lumizyme commercial opportunities and future growth; plans
to divest additional businesses, including the cell therapy
business, and the timing of such divestitures; the expected amount
of savings resulting from cost-saving efforts and opportunities;
the expected receipt, timing and results of clinical trial data for
Clolar; the anticipated timing of filing for regulatory approval
for Renvela in China; the expected receipt and timing of regulatory
approvals for alemtuzumab, mipomersen and eliglustat tartrate; the
expected size of the MS market and expectations regarding
submissions, including scope and timing, of regulatory filings for
mipomersen. These statements are subject to risks and uncertainties
that may cause actual results to differ materially. These risks and
uncertainties include, among others: that production and shipment
of Fabrazyme and Cerezyme does not continue as planned due to any
reason, including contamination, equipment malfunctions, cell
growth at lower than expected levels, fill-finish inefficiencies,
power outages, human error or regulatory issues; that Genzyme’s
business is negatively impacted by adverse events or circumstances,
including further manufacturing issues, lower than expected product
demand due to competition or higher than expected operating
expenses; that Genzyme cannot obtain on expected timetables or
maintain regulatory approvals for its products and manufacturing
facilities, including the Allston manufacturing facility, the new
Framingham facility, and the expanded fill/finish operations in
Waterford; that Genzyme is unable to successfully transition
fill/finish operations out of the Allston facility on planned
timelines; that Genzyme is not able to successfully complete
clinical development and obtain regulatory approvals of its
pipeline products within anticipated timeframes and for anticipated
indications, including alemtuzumab-MS, mipomersen and eliglustat
tartrate for any reason, including trial results that are not as
favorable as expected and safety profiles that reduce the potential
target patient population; that Genzyme is unable to complete the
sale of its pharmaceuticals business or sell other businesses as
planned or on anticipated timeframes; that Genzyme will not be able
to implement its plan to increase shareholder in a manner
consistent with expectations, including an inability to reduce
operating expenses or sustain any achieved cost savings as
expected; that Genzyme is unable to accurately assess, estimate or
forecast patient populations and product demand; and the risks and
uncertainties described in Genzyme's SEC reports filed under the
Securities Exchange Act of 1934, including the factors discussed
under the caption "Risk Factors" in Management’s Discussion and
Analysis of Financial Condition and Results of Operations in
Genzyme's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2010. Genzyme cautions investors not to place
substantial reliance on the forward-looking statements contained in
this press release. These statements speak only as of the date of
this press release and Genzyme undertakes no obligation to update
or revise them.
Genzyme®, Cerezyme®, Fabrazyme®, Myozyme®, Lumizyme®, Synvisc®,
Synvisc-One®, Renvela®, Mozobil®, Clolar® and Thymoglobulin® are
registered trademarks of Genzyme Corporation or its subsidiaries.
All rights reserved.
Important Information
Genzyme has filed with the Securities and Exchange Commission a
Solicitation/Recommendation Statement on Schedule 14D-9 relating to
the tender offer by sanofi-aventis. Genzyme shareholders are
advised to read the company's Solicitation/Recommendation Statement
on Schedule 14D-9 because it contains important information.
Shareholders may obtain a free copy of the
Solicitation/Recommendation Statement on Schedule 14D-9, as well as
any other documents filed by Genzyme in connection with the tender
offer, free of charge at the SEC's website at http://www.sec.gov.
In addition, investors can obtain free copies of these documents
from Genzyme by directing a request to Genzyme at 500 Kendall
Street, Cambridge, MA 02142, Attention: Shareholder Relations
Department, or by calling 617-252-7500 and asking for the
Shareholder Relations Department.
GENZYME CORPORATION (GENZ)
Consolidated Statements of Operations Three Months
Ended Year Ended (Unaudited, amounts in thousands,
except per share amounts)
December 31, December 31,
2010
2009 (1)
2010
2009 (1)
Total revenues $ 1,151,853 $ 938,290 $
4,048,708 $ 3,977,288 Operating costs and
expenses: Cost of products and services sold 335,067 296,136
1,191,540 1,070,347 Selling, general and administrative 350,002
340,374 1,553,921 1,244,398 Research and development 202,097
224,918 847,284 833,853 Amortization of intangibles 67,927 70,237
262,254 253,507 Restructuring charges 28,260 - 28,260 - Contingent
consideration expense 33,310 - 102,746 - Charge for impaired assets
26,873 28,297 26,873
65,584 Total operating costs and expenses
1,043,536 959,962 4,012,878
3,467,689 Operating income (loss) 108,317
(21,672 ) 35,830 509,599
Other income (expenses): Equity in loss of equity method
investments (795 ) - (3,004 ) - Gains (losses) on investments in
equity securities, net (3,583 ) 1,276 (30,334 ) (57 ) Gain on
acquisition of business - - - 24,159 Other 1,109 700 465 (1,646 )
Investment income 2,595 3,605 11,382 17,642 Interest expense
(3,668 ) - (7,026 ) - Total
other income (expenses) (4,342 ) 5,581
(28,517 ) 40,098 Income (loss) from continuing
operations before taxes 103,975 (16,091 ) 7,313 549,697 (Provision
for) benefit from income taxes (32,968 ) 37,608
24,750 (122,766 ) Income (loss) from
continuing operations, net of tax 71,007 21,517 32,063 426,931
Income (loss) from discontinued operations, net of tax
400,904 1,728 390,081
(4,631 ) Net income (loss) $ 471,911 $ 23,245 $
422,144 $ 422,300 Net income (loss) per
share-basic: Income (loss) from continuing operations, net of tax $
0.27 $ 0.08 $ 0.12 $ 1.59 Income (loss) from discontinued
operations, net of tax $ 1.55 $ 0.01 $ 1.49 $
(0.02 ) Net income (loss) $ 1.82 $ 0.09 $ 1.61
$ 1.57 Net income (loss) per share-diluted: Income
(loss) from continuing operations, net of tax $ 0.27 $ 0.08 $ 0.12
$ 1.56 Income (loss) from discontinued operations, net of tax $
1.49 $ 0.01 $ 1.45 $ (0.02 ) Net income (loss)
$ 1.76 $ 0.09 $ 1.57 $ 1.54
Weighted average shares outstanding: Basic 259,245 265,596 261,531
268,841 Diluted 268,513 270,241 268,601 274,071
GENZYME CORPORATION (GENZ)
Condensed Consolidated Balance
Sheets December 31, December 31, (Unaudited,
amounts in thousands)
2010
2009 Cash and all marketable securities $
1,950,022 $ 1,049,700 Assets held for sale-current 77,690 - Other
current assets 2,235,383 1,896,927 Property, plant and equipment,
net 2,925,585 2,809,349 Intangibles, net 3,181,797 3,716,625 Assets
held for sale-noncurrent 91,836 - Other noncurrent assets
678,762 588,123 Total assets $ 11,141,075
$ 10,060,724 Liabilities associated with
assets held for sale-current $ 21,368 $ - Other current liabilities
1,444,555 1,080,130 Noncurrent liabilities 2,033,305 1,296,942
Stockholders' equity 7,641,847 7,683,652
Total liabilities and stockholders' equity $ 11,141,075
$ 10,060,724
All amounts herein are presented in accordance with GAAP and are
provided for quantitative analysis only and should be read in
conjunction with the text of the Earnings Release. Please refer to
our Form 10-Q's and Form 10-K's for an in-depth discussion and
analysis of our results of operations and financial position and
for detailed information regarding specific material transactions
in a particular period.
In addition, we believe that certain Non-GAAP financial
measures, when considered together with the GAAP figures, can
enhance the overall understanding of the company's past financial
performance and its prospects for the future. Please refer to our
GAAP to Non-GAAP Reconciliations attached to the Earnings Releases
for the above respective periods, which are filed on Form 8-K with
the Securities and Exchange Commission at www.sec.gov. The Non-GAAP
financial measures are provided with the intent of providing
investors with a more complete understanding of the trends
underlying our operating results and financial position and are
among the primary indicators management uses for planning and
forecasting purposes and measuring the company's performance.
(1) 2009 consolidated statements of operations have been revised
to reflect discontinued operations. Discontinued operations
represents the operations of Genzyme Genetics and Genzyme
Diagnostics, net of tax.
Genzyme Corporation (GENZ) Analyst Schedule
(Amounts in thousands, except percentage amounts)
PRIOR PERIODS REVISED FOR DISCONTINUED OPERATIONS -
UNAUDITED Q4-10 vs.
Q4-09 Q4-09 Q1-10
Q2-10 Q3-10 Q4-10 % B/(W) FY
2008 FY 2009 FY 2010 Total revenues:
Personalized Genetic Health Cerezyme $ 105,368 $ 179,147 $
138,736 $ 179,781 $ 221,966 111 % $ 1,238,977 $ 793,024 $ 719,630
Fabrazyme 58,026 53,241 39,484 33,882 61,603 6 % 494,260 429,690
188,210 Myozyme 91,900 86,059 92,054 106,223 127,467 39 % 296,176
324,545 411,803 Aldurazyme 38,706 39,897 43,651 40,766 42,466 10 %
151,664 155,064 166,780 Other Personalized Genetic Health
54,042 34,160 36,619 43,531 52,052 (4
%) 114,950 147,285 166,362 Total Personalized
Genetic Health product and service revenue 348,042 392,504 350,544
404,183 505,554 45 % 2,296,027 1,849,608 1,652,785 R&D Revenue
- - - - - 110 -
-
Total Personalized Genetic Health
348,042 392,504 350,544
404,183 505,554 45 %
2,296,137
1,849,608 1,652,785 Renal and
Endocrinology Renagel and Renvela (including Sevelamer) 178,891
164,607 170,066 178,755 184,222 3 % 677,729 706,590 697,650
Hectorol 31,877 42,025 41,863 49,285
56,705 78 % 128,153 130,757 189,878
Subtotal 210,768 206,632 211,929 228,040 240,927 14 % 805,882
837,347 887,528 Thyrogen 47,267 45,625 46,300 42,257 47,772 1 %
148,448 170,644 181,954 Other Renal and Endocrinology -
- - - - - 30 -
Total Renal and Endocrinology product and service revenue 258,035
252,257 258,229 270,297 288,699 12 % 954,330 1,008,021 1,069,482
R&D revenue 155 166 150 134
178 15 % 90 331 628
Total Renal and
Endocrinology 258,190 252,423
258,379 270,431 288,877
12 %
954,420 1,008,352
1,070,110 Biosurgery Synvisc 95,419 79,507
107,686 99,998 105,885 11 % 263,094 328,533 393,076 Sepra products
40,365 37,177 38,935 40,858 44,026 9 % 133,663 148,538 160,996
Other Hyaluronic Acid products 6,698 8,984
4,818 5,908 6,937 4 % 45,587 34,597
26,647 Total Hyaluronic Acid product and service revenue
142,482 125,668 151,439 146,764 156,848 10 % 442,344 511,668
580,719 Cell Based Therapy 14,081 10,645 11,837 9,510 12,996 (8 %)
42,547 45,789 44,988 Other Biosurgery 343 494
300 258 360 5 % 3,564 1,866
1,412 Total Biosurgery product and service revenue 156,906 136,807
163,576 156,532 170,204 8 % 488,455 559,323 627,119 R&D revenue
414 559 404 200 468 13 %
2,645 2,493 1,631
Total Biosurgery
157,320 137,366 163,980
156,732 170,672 8 %
491,100
561,816 628,750 Hematology
and Oncology Mozobil 19,267 18,966 22,141 23,630 27,284 42 %
639 54,650 92,021 Thymoglobulin 58,265 52,910 58,232 56,891 61,885
6 % 183,296 215,964 229,918 Clolar 22,230 24,688 25,520 26,129
27,564 24 % 64,044 81,280 103,901 Other Hematology and Oncology
68,977 59,727 70,597 60,645
61,858 (10 %) 47,120 158,658 252,827 Total
Hematology and Oncology product and service revenue 168,739 156,291
176,490 167,295 178,591 6 % 295,099 510,552 678,667 R&D revenue
24 19 7 1 80 233 % 14,439
2,367 107
Total Hematology and Oncology
168,763 156,310 176,497
167,296 178,671 6 %
309,538
512,919 678,774 Multiple
Sclerosis R&D revenue 110 -
- - - (100 %)
21,709 12,467 -
Other Other product and service revenue 5,137
3,099 3,397 2,848 7,841 53 % 51,473
29,442 17,185 Total Other product and service revenue
5,137 3,099 3,397 2,848 7,841 53 % 51,473 29,442 17,185 R&D
revenue 728 189 367 310 238 (67
%) 3,048 2,684 1,104
Total Other
5,865 3,288 3,764
3,158 8,079 38 %
54,521
32,126 18,289 Total revenues
$ 938,290 $ 941,891 $
953,164 $ 1,001,800 $ 1,151,853
23 %
$ 4,127,425 $ 3,977,288 $
4,048,708
All amounts herein are presented in accordance with GAAP and are
provided for quantitative analysis only and should be read in
conjunction with the text of the Earnings Release and our audited
financial statements filed with the Securities and Exchange
Commission. Please refer to our Form 10-Q's and Form 10-K's for an
in-depth discussion and analysis of our results of operations and
financial position and for detailed information regarding specific
material transactions in a particular period.
RECONCILIATION
OF GAAP TO NON-GAAP EARNINGS For the Year Ended December 31,
2010 (Amounts in thousands, except percentage and per share
data) UNAUDITED OTHER
DISCRETE ITEMS (included in GAAP and Non-GAAP results)
GAAPAs Reported
ConsentDecree
BayerAcquisitionRelated
StockCompensationExpense
ExitActivities
GenzymePharmaceuticals (5) Cell
BasedTherapy DiscontinuedOperations
(3) NON-GAAP (1)
ManufacturingRelated (2)
GenzymePharmaceuticals (5)
InvestmentImpairment (4) Income Statement
Classification: Total revenues $ 4,048,708 $ - $ - $ - $
- $ (5,658 ) $ (12,995 ) $ - $ 4,030,055 $ - $ (3,082 ) $ -
Cost of products and services sold $ (1,191,540 ) $ - $
35,854 $ 19,041 $ - $ 8,247 $ 15,037 $
- $ (1,113,361 ) $ 44,938 $ 3,200 $ -
Gross margin 71 % $ 2,857,168 $ - $ 35,854 $ 19,041 $ - $ 2,589 $
2,042 72 % $ 2,916,694 $ 44,938 $ 118 $ - Selling, general
and administrative $ (1,553,921 ) $ 175,000 $ - $ 89,575 $ 3,207 $
2,169 $ 4,312 $ - $ (1,279,658 ) $ - $ 625 $ - Research and
development $ (847,284 ) $ - $ - $ 54,470 $ 1,094 $ 938 $ 4,467 $ -
$ (786,315 ) $ - $ 686 $ - Amortization of intangibles $
(262,254 ) $ - $ - $ - $ - $ - $ 329 $ - $ (261,925 ) $ - $ - $ -
Restructuring charges $ (28,260 ) $ - $ - $ - $ 28,260 $ - $
- $ - $ - $ - $ - $ - Contingent consideration expense $
(102,746 ) $ - $ 102,746 $ - $ - $ - $ - $ - $ - $ - $ - $ -
Charge for impaired assets $ (26,873 ) $ - $ - $ - $ 26,873 $ - $ -
$ - $ - $ - $ - Equity in loss of equity method investments
$ (3,004 ) $ - $ - $ - $ - $ - $ - $ - $ (3,004 ) $ - $ - $ -
Other $ (29,869 ) $ - $ - $ - $ - $ - $ - $ - $ (29,869 ) $
- $ - $ 32,250 Investment income $ 11,382 $ - $ - $ - $ - $
- $ - $ - $ 11,382 $ - $ - $ - Interest expense $ (7,026 ) $
- $ - $ - $ - $ - $ 2 $ - $ (7,024 ) $ - $ - $ -
Summary: Income (loss) from continuing
operations before income taxes $ 7,313 $ 175,000 $ 138,600 $
163,086 $ 32,561 $ 32,569 $ 11,152 $ - $ 560,281 $ 44,938 $ 1,429 $
32,250 (Provision for) benefit from income taxes -338.44 % $
24,750 $ (51,299 ) $ 6,120 $ (45,436 ) $ (8,214 ) $ (3,482 )
$ (4,240 ) $ - 14.60 % $ (81,801 ) $ (12,633 ) $ (362 ) $
(11,909 ) Income (loss) from continuing operations $ 32,063
$ 123,701 $ 144,720 $ 117,650 $ 24,347 $ 29,087 $ 6,912 $ - $
478,480 $ 32,305 $ 1,067 $ 20,341 Income (loss) from
discontinued operations, net of tax $ 390,081 $ - $ -
$ - $ - $ - $ - $ (390,081 ) $ -
$ - $ - $ - Net income (loss) $ 422,144
$ 123,701 $ 144,720 $ 117,650 $ 24,347
$ 29,087 $ 6,912 $ (390,081 ) $ 478,480 $
32,305 $ 1,067 $ 20,341 Net
income (loss) per share-basic: Income (loss) from continuing
operations, net of tax $ 0.12 $ 0.47 $ 0.55 $ 0.45 $ 0.09 $ 0.11 $
0.03 $ - $ 1.83 $ 0.12 $ 0.00 $ 0.08 Income (loss) from
discontinued operations, net of tax $ 1.49 $ - $ - $
- $ - $ - $ - $ (1.49 ) $ - $ -
$ - $ - Net income (loss) $ 1.61 $ 0.47
$ 0.55 $ 0.45 $ 0.09 $ 0.11 $ 0.03
$ (1.49 ) $ 1.83 $ 0.12 $ 0.00 $ 0.08
Net income (loss) per share-diluted: Income (loss)
from continuing operations, net of tax $ 0.12 $ 0.46 $ 0.54 $ 0.44
$ 0.09 $ 0.11 $ 0.03 $ - $ 1.78 $ 0.12 $ 0.00 $ 0.08 Income (loss)
from discontinued operations, net of tax $ 1.45 $ - $
- $ - $ - $ - $ - $ (1.45 ) $ -
$ - $ - $ - Net income (loss) $ 1.57 $
0.46 $ 0.54 $ 0.44 $ 0.09 $ 0.11 $ 0.03
$ (1.45 ) $ 1.78 $ 0.12 $ 0.00 $ 0.08
Weighted average shares outstanding: Basic
261,531 261,531 261,531 261,531 261,531 261,531 261,531 261,531
261,531 261,531 261,531 261,531 Diluted
268,601 268,601
268,601 268,601 268,601
268,601 268,601
268,601 268,601
268,601 268,601 268,601
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme
Corporation for the applicable period. We believe that certain
Non-GAAP financial measures, when considered together with the GAAP
figures, can enhance the overall understanding of the company's
past financial performance and its prospects for the future. The
Non-GAAP financial measures are included with the intent of
providing investors with a more complete understanding of the
trends underlying our operating results and financial position and
are among the primary indicators management uses for planning and
forecasting purposes and measuring the company's performance. Such
Non-GAAP financial measures should not be considered in isolation
or used as a substitute for GAAP. Earnings per share are calculated
as net income (loss) divided by weighted average shares
outstanding. Therefore, earnings per share may not add across due
to rounding.
(2) Represents write-offs of inventory that did not meet the
necessary quality specifications.
(3) Discontinued Operations represents the operations of Genzyme
Genetics and Genzyme Diagnostics, net of tax.
(4) Represents a write-down of our investment in the common
stock of ISIS Pharmaceuticals, Inc., to the extent our cost exceeds
the market value, in accordance with GAAP.
(5) Genzyme Pharmaceuticals was treated as a discrete item for
Q3 2010 and a Non-GAAP item for Q4 2010.
GENZYME CORPORATION RECONCILIATION OF GAAP
TO NON-GAAP EARNINGS For the Three Months Ended December 31,
2010 (Amounts in thousands, except percentage and per share
data) UNAUDITED
GAAPAs Reported
BayerAcquisitionRelated
StockCompensationExpense
ExitActivities
GenzymePharmaceuticals Cell
BasedTherapy
DiscontinuedOperations (2)
NON-GAAP (1)
Income Statement Classification: Total revenues $
1,151,853 $ - $ - $ - $ (5,658 ) $ (12,995 ) $ - $ 1,133,200
Cost of products and services sold $ (335,067 ) $ 8,560 $ 4,842
$ - $ 8,247 $ 15,037 $ - $
(298,381 ) Gross margin 71 % $ 816,786 $ 8,560 $ 4,842 $ 2,589 $
2,042 74 % $ 834,819 Selling, general and administrative $
(350,002 ) $ - $ 19,123 $ - $ 2,169 $ 4,312 $ - $ (324,398 )
Research and development $ (202,097 ) $ - $ 13,103 $ 1,094 $ 938 $
4,467 $ - $ (182,495 ) Amortization of intangibles $ (67,927
) $ - $ - $ - $ - $ 329 $ - $ (67,598 ) Restructuring
charges $ (28,260 ) $ - $ - $ 28,260 $ - $ - $ - $ -
Contingent consideration expense $ (33,310 ) $ 33,310 $ - $ - $ - $
- $ - $ - Charge for impaired assets $ (26,873 ) $ - $ - $ -
$ 26,873 $ - $ - $ - Equity in loss of equity method
investments $ (795 ) $ - $ - $ - $ - $ - $ - $ (795 ) Other
$ (2,474 ) $ - $ - $ - $ - $ - $ - $ (2,474 ) Investment
income $ 2,595 $ - $ - $ - $ - $ - $ - $ 2,595 Interest
expense $ (3,668 ) $ - $ - $ - $ - $ 2 $ - $ (3,666 )
Summary: Income (loss) from continuing
operations before income taxes $ 103,975 $ 41,870 $ 37,068 $ 29,354
$ 32,569 $ 11,152 $ - $ 255,988 (Provision for) benefit from
income taxes 31.71 % $ (32,968 ) $ 21,514 $ (8,085 ) $ (7,610 ) $
(3,482 ) $ (4,240 ) $ - 13.62 % $ (34,871 ) Income
(loss) from continuing operations $ 71,007 $ 63,384 $ 28,983 $
21,744 $ 29,087 $ 6,912 $ - $ 221,117 Income (loss) from
discontinued operations, net of tax $ 400,904 $ - $ -
$ - $ - $ - $ (400,904 ) $ - Net
income (loss) $ 471,911 $ 63,384 $ 28,983 $ 21,744
$ 29,087 $ 6,912 $ (400,904 ) $ 221,117
Net income (loss) per share-basic: Income (loss) from
continuing operations, net of tax $ 0.27 $ 0.24 $ 0.11 $ 0.08 $
0.11 $ 0.03 $ - $ 0.85 Income (loss) from discontinued operations,
net of tax $ 1.55 $ - $ - $ - $ - $ -
$ (1.55 ) $ - Net income (loss) $ 1.82 $ 0.24
$ 0.11 $ 0.08 $ 0.11 $ 0.03 $ (1.55 ) $
0.85 Net income (loss) per share-diluted: Income
(loss) from continuing operations, net of tax $ 0.27 $ 0.24 $ 0.11
$ 0.08 $ 0.11 $ 0.03 $ - $ 0.82 Income (loss) from discontinued
operations, net of tax $ 1.49 $ - $ - $ - $ -
$ - $ (1.49 ) $ - Net income (loss) $ 1.76
$ 0.24 $ 0.11 $ 0.08 $ 0.11 $ 0.03
$ (1.49 ) $ 0.82 Weighted average
shares outstanding: Basic 259,245 259,245 259,245 259,245 259,245
259,245 259,245 259,245 Diluted 268,513
268,513 268,513
268,513
268,513 268,513
268,513
268,513
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme
Corporation for the applicable period. We believe that certain
Non-GAAP financial measures, when considered together with the GAAP
figures, can enhance the overall understanding of the company's
past financial performance and its prospects for the future. The
Non-GAAP financial measures are included with the intent of
providing investors with a more complete understanding of the
trends underlying our operating results and financial position and
are among the primary indicators management uses for planning and
forecasting purposes and measuring the company's performance. Such
Non-GAAP financial measures should not be considered in isolation
or used as a substitute for GAAP. Earnings per share are calculated
as net income (loss) divided by weighted average shares
outstanding. Therefore, earnings per share may not add across due
to rounding.
(2) Discontinued Operations represents the operations of Genzyme
Genetics and Genzyme Diagnostics, net of tax.
GENZYME CORPORATION RECONCILIATION
OF GAAP TO NON-GAAP EARNINGS For the Year Ended December 31,
2009 (Amounts in thousands, except percentage and per share
data) REVISED FOR DISCONTINUED OPERATIONS - UNAUDITED
GAAPAs Reported
BayerAcquisitionRelated
StockCompensationExpense
DiscontinuedOperations (2)
NON-GAAP (1) Income Statement
Classification: Total revenues $ 3,977,288 $ - $ - $ - $
3,977,288 Cost of products and services sold $ (1,070,347 )
$ 36,822 $ 22,273 $ - $ (1,011,252 ) Gross margin 73
% $ 2,906,941 $ 36,822 $ 22,273 $ - 75 % $ 2,966,036
Selling, general and administrative $ (1,244,398 ) $ - $ 100,741 $
- $ (1,143,657 ) Research and development $ (833,853 ) $ - $
60,118 $ - $ (773,735 ) Amortization of intangibles $
(253,507 ) $ - $ - $ - $ (253,507 ) Contingent consideration
expense $ (65,584 ) $ 65,584 $ - $ - $ - Gains (losses) on
investments in equity securities $ (57 ) $ - $ - $ - $ (57 )
Gain on acquisition of business $ 24,159 $ (24,159 ) $ - $ - $ -
Other $ (1,646 ) $ - $ - $ - $ (1,646 ) Investment
income $ 17,642 $ - $ - $ - $ 17,642
Summary:
Income (loss) from continuing operations before income taxes
$ 549,697 $ 78,247 $ 183,132 $ - $ 811,076 (Provision for)
benefit from income taxes 22.33 % $ (122,766 ) $ (29,780 ) $
(46,987 ) $ - 24.60 % $ (199,533 ) Income (loss) from
continuing operations $ 426,931 $ 48,467 $ 136,145 $ - $ 611,543
Income (loss) from discontinued operations, net of tax $
(4,631 ) $ - $ - $ 4,631 $ - Net income
(loss) $ 422,300 $ 48,467 $ 136,145 $ 4,631 $
611,543 Net income (loss) per share-basic:
Income (loss) from continuing operations, net of tax $ 1.59 $ 0.18
$ 0.51 $ - $ 2.27 Income (loss) from discontinued operations, net
of tax $ (0.02 ) $ - $ - $ 0.02 $ - Net income
(loss) $ 1.57 $ 0.18 $ 0.51 $ 0.02 $ 2.27
Net income (loss) per share-diluted: Income (loss)
from continuing operations, net of tax $ 1.56 $ 0.18 $ 0.50 $ - $
2.23 Income (loss) from discontinued operations, net of tax $ (0.02
) $ - $ - $ 0.02 $ - Net income (loss) $ 1.54
$ 0.18 $ 0.50 $ 0.02 $ 2.23
Weighted average shares outstanding: Basic 268,841 268,841
268,841 268,841 268,841 Diluted 274,071
274,071
274,071 274,071
274,071
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme
Corporation for the applicable period. We believe that certain
Non-GAAP financial measures, when considered together with the GAAP
figures, can enhance the overall understanding of the company's
past financial performance and its prospects for the future. The
Non-GAAP financial measures are included with the intent of
providing investors with a more complete understanding of the
trends underlying our operating results and financial position and
are among the primary indicators management uses for planning and
forecasting purposes and measuring the company's performance. Such
Non-GAAP financial measures should not be considered in isolation
or used as a substitute for GAAP. Earnings per share are calculated
as net income (loss) divided by weighted average shares
outstanding. Therefore, earnings per share may not add across due
to rounding.
(2) Discontinued Operations represents the operations of Genzyme
Genetics and Genzyme Diagnostics, net of tax.
GENZYME CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS For the Three
Months Ended December 31, 2009 (Amounts in thousands, except
percentage and per share data) REVISED FOR DISCONTINUED
OPERATIONS - UNAUDITED
GAAPAs Reported
BayerAcquisitionRelated
StockCompensationExpense
DiscontinuedOperations (2)
NON-GAAP (1) Income Statement
Classification: Total revenues $ 938,290 $ - $ - $ - $
938,290 Cost of products and services sold $ (296,136 ) $
19,082 $ 7,388 $ - $ (269,666 ) Gross margin
68 % $ 642,154 $ 19,082 $ 7,388 $ - 71 % $ 668,624 Selling,
general and administrative $ (340,374 ) $ - $ 21,767 $ - $ (318,607
) Research and development $ (224,918 ) $ - $ 13,657 $ - $
(211,261 ) Amortization of intangibles $ (70,237 ) $ - $ - $
- $ (70,237 ) Contingent consideration expense $ (28,297 ) $
28,297 $ - $ - $ - Gains (losses) on investments in equity
securities $ 1,276 $ - $ - $ - $ 1,276 Other $ 700 $ - $ - $
- $ 700 Investment income $ 3,605 $ - $ - $ - $ 3,605
Summary: Income (loss) from continuing
operations before income taxes $ (16,091 ) $ 47,379 $ 42,812 $ - $
74,100 (Provision for) benefit from income taxes 233.72 % $
37,608 $ (22,232 ) $ (11,391 ) $ - -5.38 % $ 3,985
Income (loss) from continuing operations $ 21,517 $
25,147 $ 31,421 $ - $ 78,085 Income (loss) from discontinued
operations, net of tax $ 1,728 $ - $ - $
(1,728 ) $ - Net income (loss) $ 23,245 $
25,147 $ 31,421 $ (1,728 ) $ 78,085
Net income (loss) per share-basic: Income (loss) from
continuing operations, net of tax $ 0.08 $ 0.09 $ 0.12 $ - $ 0.29
Income (loss) from discontinued operations, net of tax $ 0.01
$ - $ - $ (0.01 ) $ - Net income (loss)
$ 0.09 $ 0.09 $ 0.12 $ (0.01 ) $ 0.29
Net income (loss) per share-diluted: Income (loss) from
continuing operations, net of tax $ 0.08 $ 0.09 $ 0.12 $ - $ 0.29
Income (loss) from discontinued operations, net of tax $ 0.01
$ - $ - $ (0.01 ) $ - Net income (loss)
$ 0.09 $ 0.09 $ 0.12 $ (0.01 ) $ 0.29
Weighted average shares outstanding: Basic 265,596
265,596 265,596 265,596 265,596 Diluted
270,241 270,241
270,241 270,241
270,241
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme
Corporation for the applicable period. We believe that certain
Non-GAAP financial measures, when considered together with the GAAP
figures, can enhance the overall understanding of the company's
past financial performance and its prospects for the future. The
Non-GAAP financial measures are included with the intent of
providing investors with a more complete understanding of the
trends underlying our operating results and financial position and
are among the primary indicators management uses for planning and
forecasting purposes and measuring the company's performance. Such
Non-GAAP financial measures should not be considered in isolation
or used as a substitute for GAAP. Earnings per share are calculated
as net income (loss) divided by weighted average shares
outstanding. Therefore, earnings per share may not add across due
to rounding.
(2) Discontinued Operations represents the operations of Genzyme
Genetics and Genzyme Diagnostics, net of tax.
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