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8-K - FORM 8-K - GENZYME CORP | b85002e8vk.htm |
EX-2.1 - EX-2.1 - GENZYME CORP | b85002exv2w1.htm |
EX-99.2 - EX-99.2 - GENZYME CORP | b85002exv99w2.htm |
EX-10.1 - EX-10.1 - GENZYME CORP | b85002exv10w1.htm |
Exhibit 99.1
For Immediate Release
|
Media Contact: | Investor Contact: | ||
February 16, 2011
|
Erin Emlock (617) 768-6923 |
Patrick Flanigan (617) 768-6563 |
Genzyme Reports Financial Results for Fourth Quarter of 2010 and Full Year
Recovery Continues with Growth Across All Businesses
CAMBRIDGE, Mass. 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, Genzymes 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 companys 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 companys 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 companys 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 Genzymes 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 companys 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 Genzymes 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 Genzymes 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 companys 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 Renvelas 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
products use in hyperphosphatemic CKD patients who are on dialysis, and in those who are not on
dialysis.
Promising Late-Stage Pipeline
Within Genzymes 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, Genzymes 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 worlds 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 companys products and services are focused on rare inherited disorders, kidney
disease, orthopaedics, cancer, transplant and immune disease. Genzymes 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.
Genzymes press releases and other company information are available at www.genzyme.com and by
calling Genzymes 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 Genzymes 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 Genzymes
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 Genzymes SEC reports
filed under the Securities Exchange Act of 1934, including the factors discussed under the caption
Risk Factors in Managements Discussion and Analysis of Financial Condition and Results of
Operations in Genzymes 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 companys 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 SECs 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-Qs and Form 10-Ks 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 companys 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 companys 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-Qs and Form 10-Ks 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.
GENZYME CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS
For the Year Ended December 31, 2010
(Amounts in thousands, except percentage and per share data)
UNAUDITED
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) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Bayer | Stock | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GAAP | Consent | Acquisition | Compensation | Exit | Genzyme | Cell Based | Discontinued | Manufacturing | Genzyme | Investment | ||||||||||||||||||||||||||||||||||||||||||||||||||
As Reported | Decree | Related | Expense | Activities | Pharmaceuticals(5) | Therapy | Operations(3) | NON-GAAP(1) | Related(2) | Pharmaceuticals(5) | Impairment(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 companys 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 companys 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
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
Bayer | Stock | ||||||||||||||||||||||||||||||||||||||||||
GAAP | Acquisition | Compensation | Exit | Genzyme | Cell Based | Discontinued | |||||||||||||||||||||||||||||||||||||
As Reported | Related | Expense | Activities | Pharmaceuticals | Therapy | Operations(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 companys
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 companys 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
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
Bayer | Stock | ||||||||||||||||||||||||||||||
GAAP | Acquisition | Compensation | Discontinued | ||||||||||||||||||||||||||||
As Reported | Related | Expense | Operations(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 companys 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 companys 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
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
Bayer | Stock | ||||||||||||||||||||||||||||||
GAAP | Acquisition | Compensation | Discontinued | ||||||||||||||||||||||||||||
As Reported | Related | Expense | Operations(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 companys 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 companys 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.