July 21, 2010 08:20 AM Eastern Daylight Time
Genzyme Reports Financial Results for the Second Quarter of 2010
Provides New 2010 Non-GAAP EPS Guidance of $1.90 - $2.00
Updates Product Supply Outlook
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corp. (NASDAQ: GENZ) today reported that second-quarter revenue
was $1.08 billion, compared with $1.23 billion in the same period last
year, reflecting limited shipments of Cerezyme® (imiglucerase
for injection) and Fabrazyme® (agalsidase beta) due to
product supply constraints in 2010. The company expects to be able to
increase shipments of Cerezyme and Fabrazyme during the second half of
the year.
“This was a difficult quarter as reflected in our financial results, but
based on the progress we’ve made with our recovery efforts, the outlook
for the second half of 2010 is promising”
GAAP net income was $23,000, or $0.00 per diluted share, compared with
net income of $187.6 million, or $0.68 per diluted share, in the second
quarter of 2009. Non-GAAP net income was $47.6 million, or $0.18 per
diluted share, compared with $226.6 million, or $0.82 per diluted share,
in the same period last year.
GAAP and non-GAAP figures include pre-tax manufacturing write-offs of
$21.9 million, or $0.06 per diluted share, primarily for material that
had to be discarded following the interruption in operations at the
Allston facility late in the first quarter and for costs associated with
the temporary shutdown of the company’s Haverhill, U.K., facility in
December 2009. These figures also include a pre-tax write-down of $32.3
million, or $0.08 per diluted share, for the company’s 2008 equity
investment in Isis Pharmaceuticals, reflecting the extent to which the
share price paid exceeds the current market value. Non-GAAP net income
excludes stock compensation expenses and costs associated with the
acquisition of oncology products from Bayer.
“This was a difficult quarter as reflected in our financial results, but
based on the progress we’ve made with our recovery efforts, the outlook
for the second half of 2010 is promising,” said Henri A. Termeer,
Genzyme’s chairman and chief executive officer. “We are encouraged by
the improvements in Cerezyme and Fabrazyme manufacturing. We expect that
increasing sales of these products combined with reductions in our
operating costs will produce an increase in earnings during the second
half of the year.”
During the second quarter, Genzyme continued to make progress in
transforming its manufacturing operations, maximizing the potential of
its product portfolio, and advancing key pipeline programs to ensure
sustainable long-term growth. Major operational milestones included FDA
approval of Lumizyme™ (alglucosidase alfa) for late-onset Pompe disease
patients in the United States; progress in moving fill/finish operations
out of the Allston manufacturing facility; and the strongest quarter to
date in the ongoing U.S. launch of Synvisc-One.
The company also continues to make progress in executing its plan for
shareholder value creation announced in May. The plan builds on the
series of operational and organizational changes the company has made
over the past year.
-
Last month, Genzyme completed a debt offering of $1 billion. This debt
was used to enter into an accelerated stock buyback for the first half
of a $2 billion share repurchase. The full impact of this buyback on
the company’s weighted average share count will be seen in the third
and fourth quarters.
-
The company has made progress in its efforts to find strategic
alternatives for its Genetics, Diagnostics, and Pharmaceuticals
businesses, and is on-track to complete transactions by the end of
this year.
-
Genzyme has retained independent consultants and has begun identifying
potential efficiencies and cost reductions to improve its operating
margins. The company is in the process of evaluating its global
organization and cost structure to develop a multi-year action plan
which will be implemented beginning this fall.
In the area of corporate governance, Genzyme settled its proxy contest
and shareholders re-elected all of the company’s directors. In addition,
Genzyme’s board appointed Steven Burakoff, M.D., Eric Ende, M.D., and
Dennis Fenton, Ph.D., as directors.
Product Supply Update
Cerezyme
Production of Cerezyme is now in-line with historical averages and the
Allston facility remains fully operational. With production proceeding
successfully, Genzyme will begin increasing shipments in August. The
company expects that patients will be able to begin increasing their
doses in September and return to normal dosing in the fourth quarter.
Genzyme will increasingly look to make therapy available to new patients
in need during the fourth quarter as supply becomes available.
Fabrazyme
Genzyme continues its efforts to improve the productivity of the
Fabrazyme manufacturing process, and has received both FDA and EMA
approval to use the new working cell bank. As previously communicated,
the current shipping allocations will remain in place for the third
quarter. Shipments of Fabrazyme are expected to increase in the fourth
quarter.
Since levels of demand, ordering patterns and dose regimens vary by
region, Genzyme staff in countries around the world will provide
patients and physicians with more information on the local impact of
this guidance for each product. Because inventories remain limited, any
manufacturing disruptions or delays in shipping can impact availability
of Cerezyme and Fabrazyme.
At the company’s new Framingham manufacturing facility, two bioreactors
are currently operational and Fabrazyme engineering runs are planned for
September. The facility is on-track for approval, anticipated in late
2011.
Consent Decree
During the second quarter, Genzyme began implementing changes to address
requirements of the FDA consent decree, including transitioning
fill/finish operations out of its Allston facility. The company signed a
new agreement with Hospira Worldwide Inc., which will provide
fill/finish manufacturing services for some of the company’s products.
Genzyme has transitioned fill/finish for Cerezyme and Myozyme to its
Waterford, Ireland facility, and is in the process of transferring
Thyrogen® (thyrotropin alfa for injection) and Fabrazyme
fill/finish to Hospira. Process validation runs for Thyrogen and
Fabrazyme are underway at Hospira, and the company is on-track to meet
its late November 2010 deadlines to complete this transition for all
Thyrogen and Fabrazyme that is sold in the United States.
2010 Financial Guidance
Genzyme is providing new 2010 financial guidance based on several
factors, including: updated information regarding Cerezyme and Fabrazyme
supply; the consent decree; and the estimated impact of foreign
exchange, health care reform in the United States, and new product
pricing being implemented in the European Union. Please see the attached
guidance sheet for additional detail and a reconciliation to the
company’s previous guidance.
Cerezyme revenue is expected to be $725 million - $775 million and
Fabrazyme revenue is expected to be $200 million - $220 million. Total
2010 revenue is expected to be $4.4 billion - $4.5 billion. Non-GAAP EPS
is expected to be $0.40 - $0.50 per diluted share in the third quarter,
$0.90 - $1.00 per diluted share in the fourth quarter, and $1.90 - $2.00
per diluted share for the full year. This new guidance excludes revenue
and expenses in the second half of the year for the three businesses
that are expected to be divested.
Second Quarter Results and Business Updates
Within the Personalized Genetic Health segment, second-quarter sales of
Myozyme® (alglucosidase alfa) increased 16 percent to $92.1
million from $79.3 million in the same period in 2009. Second-quarter
revenue reflects a negative $3.7 million impact of foreign exchange.
Genzyme on May 24 received FDA approval for Lumizyme, and has
implemented a Risk Evaluation and Mitigation Strategy (called the
Lumizyme ACE Program) to ensure that the appropriate patients receive
Lumizyme commercially.
Genzyme has initiated this program with the health care professionals
involved in the Alglucosidase Alfa Temporary Access Program (ATAP), the
program created in 2007 through which Genzyme has provided therapy free
of charge to nearly 200 patients prior to commercial approval of
Lumizyme. Genzyme will keep ATAP open until August 20, 2010 to ensure
that patients have uninterrupted therapy while working to enroll
participants in the Lumizyme ACE Program. Genzyme has also begun working
with U.S. health care professionals to enable those adult patients who
have been waiting to access treatment to begin Lumizyme therapy.
Second-quarter sales of Cerezyme were $138.7 million compared with
$298.1 million in the second quarter of last year and sales of Fabrazyme
were $39.5 million, compared with $134.3 million in the same period last
year. Due to supply constraints, Cerezyme was shipped at 50 percent of
demand and Fabrazyme was shipped at 30 percent of demand for the entire
second quarter.
Within the Biosurgery segment, sales of Synvisc® (hylan G-F
20) increased 31 percent to $107.7 million from $82.4 million in last
year’s second quarter, driven by Synvisc-One, which was launched in the
United States in March 2009. Growth is resulting both from gains in
market share and from overall expansion of the U.S. viscosupplement
market, which grew approximately 14 percent in the first half of 2010
compared with the same period last year. Synivsc-One now represents
two-thirds of all U.S. Synvisc revenue.
Within the Renal and Endocrinology segment, sales of Genzyme’s sevelamer
therapies, Renvela® (sevelamer carbonate) and Renagel®
(sevelamer hydrochloride), were $170.1 million, compared with $175.4
million during the second quarter of 2009, reflecting increased U.S.
sales volume offset by price decreases being implemented by some E.U.
countries. The ongoing launch of Renvela in Europe continues to progress
well, with launches in the key markets of France, Spain, Italy and the
U.K. expected to take place during the second half of 2010.
Sales of Thyrogen increased 8 percent to $46.3 million from $42.9
million in the second quarter of 2009. In accordance with terms of the
consent decree, a Dear Healthcare Provider letter describing the
patients for whom FDA considers Thyrogen to be medically necessary is
currently being included in all U.S. shipments of Thyrogen. Genzyme has
limited its promotional activities in the United States to be consistent
with the requirements of the consent decree. Once fill/finish operations
are transferred to Hospira, the criteria will no longer be in effect and
Genzyme will resume normal U.S. promotional work.
Total revenue for the Hematology and Oncology segment, including the
oncology products acquired from Bayer in May 2009, increased 58 percent
to $176.5 million from $112.0 million in last year’s second quarter.
Within this segment, sales of Mozobil® (plerixafor injection)
nearly doubled to $22.1 million from $11.7 million in the second quarter
last year, reflecting a 23 percent increase in U.S. sales and the robust
launch in Europe. Sales of Thymoglobulin® (anti-thymocyte
globulin, rabbit) increased 9 percent to $58.2 million compared with
$53.6 million in the second quarter of 2009, with significant growth
coming from the Asia-Pacific region.
Second-quarter growth in this segment was also driven by sales of Clolar®
(clofarabine injection), which increased 29 percent to $25.5 million
from $19.7 million in the same period a year ago, with volume growth
occurring in all major markets. Data from the phase 3 trial of Clolar in
combination with an approved therapy in second-line adult acute myeloid
leukemia are expected in the fourth quarter, and positive findings would
support regulatory filings for a label expansion in this indication.
Other revenue – which includes the company’s Genetics, Diagnostics, and
Pharmaceuticals businesses – was $130.0 million in the second quarter of
2010 compared with $143.1 million in the same period last year.
Operating Expenses
Genzyme’s GAAP SG&A was $402.5 million, compared with $354.1 million in
the second quarter of 2009. Non-GAAP SG&A was $375.9 million compared
with $316.3 million in the same period last year. SG&A reflects expenses
associated with the acquisition of the Bayer oncology products, the
proxy contest, and consent decree legal fees.
The company’s GAAP R&D was $225.6 million compared with $210.5 million
in last year’s second quarter; non-GAAP R&D was $211.5 million compared
with $190.7 million in the second quarter of 2009.
Late-Stage R&D Programs
Genzyme has a strong late-stage pipeline that is expected to help drive
long-term growth:
-
Five-year follow-up data from Genzyme’s phase 2 trial of alemtuzumab
in multiple sclerosis have been accepted for presentation at the
European Committee for Treatment and Research in Multiple Sclerosis
annual meeting in October. Two phase 3 studies are ongoing and data
are expected next year. Genzyme has finalized its regulatory filing
strategy, and now plans to await results of both phase 3 studies and
file with data from the two trials to provide the most robust
submission. The company expects to file for U.S. and E.U. approval in
early 2012, and has been granted fast track status by the FDA for this
submission.
-
Enrollment is underway in three global, multi-center, phase 3 trials
of eliglustat tartrate, Genzyme’s investigational oral therapy for
patients with Gaucher disease type 1. There are currently a total of
48 active sites for these trials, with additional sites preparing to
begin enrollment. This therapy has the potential to transform the
treatment experience for patients by providing a daily oral capsule
option instead of bi-weekly infusions.
-
Genzyme and Isis Pharmaceuticals Inc. expect to report data this
quarter from two phase 3 studies of mipomersen: one includes patients
with severe hypercholesterolemia and the other includes
hypercholesterolemic patients at high risk for coronary heart disease.
These two studies are the last of the four phase 3 trials that will
contribute to the initial U.S. and E.U. regulatory filings for the
product, which will seek approval for the treatment of patients with
the genetic disease homozygous familial hypercholesterolemia. These
two filings may also include patients with severe
hypercholesterolemia, and are anticipated in the first half of 2011.
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 more than 12,000 employees in locations
spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme
was named to the Fortune 500.
With many established products and services helping patients in 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 outlook and business plans including, without
limitation: its 2010 financial guidance; its expectations regarding
shipments of Cerezyme and Fabrazyme and patient dosing of Cerezyme; its
expectation that its new Framingham manufacturing facility will be
approved in late 2011; its expectation of when results from its two
phase 3 studies of alemtuzumab in MS patients will be available and its
regulatory filing plans and timetables for the product; its assessment
that the company is on track to meet its deadlines to transition all
Thyrogen and Fabrazyme fill/finish operations for product sold in the
U.S. to Hospira; its assessment that the planned divestitures of three
of its business units are on-track for completion by year end; its
expectations regarding mipomersen, including the timing of data
availability from two phase 3 studies and the anticipated regulatory
filing strategy and timing; its expectation that Renvela will be
launched in key European markets during the second half of 2010; and its
expectations for Clolar, including that data from the phase 3 trial of
Clolar in combination in second-line adult AML will be available in the
fourth quarter and that such data will support a label expansion; its
plans to begin implementation of a multi-year action plan to improve
operating margins in the fall; and its assessment that eliglustat
tartrate has the potential to transform the treatment experience for
Gaucher patients. 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 is unable to
meet its 2010 financial guidance for any reason, including due to lower
than expected revenues attributable to further manufacturing issues or
an inability to transition Lumizyme patients to commercial product as
quickly as anticipated, or higher than expected operating expenses; that
Genzyme cannot obtain on expected timetables or maintain regulatory
approvals for its products and manufacturing facilities, including its
Allston manufacturing facility, its new Framingham facility, and a third
Myozyme bioreactor in its Geel facility; that Genzyme is unable to
successfully transition its fill/finish operations out of its Allston
facility to its Waterford, Ireland plant and to Hospira on planned
timelines; that Genzyme is not able to successfully complete clinical
development and obtain regulatory approvals of its product candidates
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 population; that Genzyme is
unable to complete any or all of its planned business divestitures by
the end of the year; 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 March 31, 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 July 21, 2010 and
Genzyme undertakes no obligation to update or revise them.
Genzyme®, Cerezyme®, Fabrazyme®, Myozyme®,
Synvisc®, Synvisc-One®, Renvela®,
Renagel®, Thyrogen®, Mozobil®, Clolar®,
and Thymoglobulin® are registered trademarks and Lumizyme™ is
a trademark of Genzyme Corporation or its subsidiaries. All rights
reserved.
Conference Call Information
Genzyme will host a conference call today at 11 a.m. Eastern. To
participate in the call, please dial 773-799-3828 and refer to pass code
“Genzyme.” A replay of this call will be available by dialing
402-998-1512. This call will also be Webcast live on the investor events
section of www.genzyme.com.
Replays of the call and the Webcast will be available until midnight on
July 28, 2010.
Upcoming Events
On October 20, 2010, Genzyme will report its financial results for the
third quarter of 2010. There will be a conference call at 11 a.m.
Eastern. To participate in the call, please dial 773-799-3828 and refer
to pass code “Genzyme.” A replay of this call will be available by
dialing 203-369-3645. This call will also be Webcast live on the
investor events section of www.genzyme.com.
Replays of the call and the Webcast will be available until midnight on
October 27, 2010.
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GENZYME CORPORATION (GENZ)
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Consolidated Statements of Operations
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Three Months Ended
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Six Months Ended
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(Unaudited, amounts in thousands, except per share amounts)
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June 30,
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June 30,
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2010
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2009
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2010
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2009
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Total revenues
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$
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1,079,439
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$
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1,228,510
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$
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2,153,912
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$
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2,377,381
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Operating costs and expenses:
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Cost of products and services sold
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361,671
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350,523
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707,282
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646,335
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Selling, general and administrative
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402,535
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354,128
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955,845
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672,089
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Research and development
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225,558
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210,522
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446,488
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|
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417,447
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Amortization of intangibles
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67,891
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|
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63,945
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|
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138,875
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|
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121,543
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Contingent consideration expense
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10,021
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|
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9,090
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72,570
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|
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9,090
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Total operating costs and expenses
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1,067,676
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988,208
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2,321,060
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1,866,504
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Operating income (loss)
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11,763
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240,302
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(167,148
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)
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510,877
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Other income (expenses):
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Gain (loss) on investments in equity securities, net
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(870
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)
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(105
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)
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(1,567
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)
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(681
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)
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Gain on acquisition of business
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-
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24,159
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-
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24,159
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Other
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(31,207
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)
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(2,056
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)
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(31,646
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)
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(3,035
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)
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Investment income
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3,084
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4,144
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6,384
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9,494
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Interest expense
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1
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-
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1
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-
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Total other income (expenses)
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(28,992
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)
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26,142
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(26,828
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)
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29,937
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Income (loss) before income taxes
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(17,229
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)
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266,444
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(193,976
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)
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540,814
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(Provision for) benefit from income taxes
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17,252
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(78,870
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)
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79,051
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(157,754
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)
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Net income (loss)
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$
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23
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$
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187,574
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$
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(114,925
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)
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$
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383,060
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Net income (loss) per share:
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Basic
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$
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0.00
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$
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0.69
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$
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(0.43
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)
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$
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1.42
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Diluted (1)
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$
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0.00
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$
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0.68
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$
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(0.43
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)
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$
|
1.39
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Weighted average shares outstanding:
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Basic
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265,270
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269,958
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265,760
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270,406
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Diluted (1)
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270,125
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|
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274,852
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|
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265,760
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276,225
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GENZYME CORPORATION (GENZ)
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Condensed Consolidated Balance Sheets
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June 30,
|
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December 31,
|
|
(Unaudited, amounts in thousands)
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2010
|
|
2009
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and all marketable securities
|
|
|
|
|
|
|
|
|
|
$
|
974,154
|
|
|
$
|
1,049,700
|
|
|
Other current assets
|
|
|
|
|
|
|
|
|
|
|
1,865,324
|
|
|
|
1,896,927
|
|
|
Property, plant and equipment, net
|
|
|
|
|
|
|
|
|
|
|
2,846,148
|
|
|
|
2,809,349
|
|
|
Intangibles, net
|
|
|
|
|
|
|
|
|
|
|
3,367,068
|
|
|
|
3,716,625
|
|
|
Other noncurrent assets
|
|
|
|
|
|
|
|
|
|
|
715,006
|
|
|
|
588,123
|
|
|
Total assets
|
|
|
|
|
|
|
|
|
|
$
|
9,767,700
|
|
|
$
|
10,060,724
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
|
$
|
1,268,537
|
|
|
$
|
1,080,130
|
|
|
Noncurrent liabilities
|
|
|
|
|
|
|
|
|
|
|
2,019,958
|
|
|
|
1,296,942
|
|
|
Stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
6,479,205
|
|
|
|
7,683,652
|
|
|
Total liabilities and stockholders' equity
|
|
|
|
|
|
|
|
|
|
$
|
9,767,700
|
|
|
$
|
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 as 8-K's 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) Diluted net loss per share and diluted weighted average shares
outstanding for the six months ended June 30, 2010 excludes the
effect of all common stock equivalents because their effect would be
anti-dilutive due to our net loss for the period.
|
|
|
|
|
Genzyme Corporation (GENZ)
|
|
|
Analyst Schedule
|
|
|
(Unaudited, amounts in thousands, except percentage amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q2-10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
vs.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q2-09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q2-09
|
|
Q3-09
|
|
Q4-09
|
|
Q1-10
|
|
Q2-10
|
|
% B/(W)
|
|
FY 2008
|
|
FY 2009
|
|
YTD 6/30/10
|
|
Total revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Personalized Genetic Health
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerezyme
|
$
|
298,087
|
|
$
|
93,599
|
|
$
|
105,368
|
|
$
|
179,147
|
|
$
|
138,736
|
|
(53%)
|
|
$
|
1,238,977
|
|
$
|
793,024
|
|
$
|
317,883
|
|
Fabrazyme
|
|
134,302
|
|
|
115,161
|
|
|
58,026
|
|
|
53,241
|
|
|
39,484
|
|
(71%)
|
|
|
494,260
|
|
|
429,690
|
|
|
92,725
|
|
Myozyme
|
|
79,273
|
|
|
85,980
|
|
|
91,900
|
|
|
86,059
|
|
|
92,054
|
|
16%
|
|
|
296,176
|
|
|
324,545
|
|
|
178,113
|
|
Aldurazyme
|
|
39,190
|
|
|
40,331
|
|
|
38,707
|
|
|
39,897
|
|
|
43,651
|
|
11%
|
|
|
151,664
|
|
|
155,065
|
|
|
83,548
|
|
Other Personalized Genetic Health
|
|
30,876
|
|
|
34,807
|
|
|
54,043
|
|
|
34,160
|
|
|
36,615
|
|
19%
|
|
|
114,950
|
|
|
147,286
|
|
|
70,775
|
|
Total Personalized Genetic Health product and service revenue
|
|
581,728
|
|
|
369,878
|
|
|
348,044
|
|
|
392,504
|
|
|
350,540
|
|
(40%)
|
|
|
2,296,027
|
|
|
1,849,610
|
|
|
743,044
|
|
R&D Revenue
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
110
|
|
|
-
|
|
|
-
|
|
Total Personalized Genetic Health
|
|
581,728
|
|
|
369,878
|
|
|
348,044
|
|
|
392,504
|
|
|
350,540
|
|
(40%)
|
|
|
2,296,137
|
|
|
1,849,610
|
|
|
743,044
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal and Endocrinology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renagel and Renvela (including Sevelamer)
|
|
175,398
|
|
|
181,702
|
|
|
178,890
|
|
|
164,607
|
|
|
170,066
|
|
(3%)
|
|
|
677,729
|
|
|
706,589
|
|
|
334,673
|
|
Hectorol
|
|
28,981
|
|
|
36,869
|
|
|
31,877
|
|
|
42,025
|
|
|
41,863
|
|
44%
|
|
|
128,153
|
|
|
130,757
|
|
|
83,888
|
|
Subtotal
|
|
204,379
|
|
|
218,571
|
|
|
210,767
|
|
|
206,632
|
|
|
211,929
|
|
4%
|
|
|
805,882
|
|
|
837,346
|
|
|
418,561
|
|
Thyrogen
|
|
42,860
|
|
|
41,691
|
|
|
47,267
|
|
|
45,625
|
|
|
46,300
|
|
8%
|
|
|
148,448
|
|
|
170,644
|
|
|
91,925
|
|
Other Renal and Endocrinology
|
|
30
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
(100%)
|
|
|
-
|
|
|
30
|
|
|
-
|
|
Total Renal and Endocrinology product and service revenue
|
|
247,269
|
|
|
260,262
|
|
|
258,034
|
|
|
252,257
|
|
|
258,229
|
|
4%
|
|
|
954,330
|
|
|
1,008,020
|
|
|
510,486
|
|
R&D revenue
|
|
8
|
|
|
156
|
|
|
155
|
|
|
166
|
|
|
150
|
|
>100%
|
|
|
90
|
|
|
332
|
|
|
316
|
|
Total Renal and Endocrinology
|
|
247,277
|
|
|
260,418
|
|
|
258,189
|
|
|
252,423
|
|
|
258,379
|
|
4%
|
|
|
954,420
|
|
|
1,008,352
|
|
|
510,802
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biosurgery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synvisc
|
|
82,417
|
|
|
87,526
|
|
|
95,419
|
|
|
79,507
|
|
|
107,686
|
|
31%
|
|
|
263,094
|
|
|
328,533
|
|
|
187,193
|
|
Sepra products
|
|
36,038
|
|
|
37,831
|
|
|
40,365
|
|
|
37,177
|
|
|
38,935
|
|
8%
|
|
|
133,663
|
|
|
148,538
|
|
|
76,112
|
|
Other Hyaluronic Acid products
|
|
8,113
|
|
|
8,800
|
|
|
6,698
|
|
|
8,984
|
|
|
4,818
|
|
(41%)
|
|
|
45,587
|
|
|
34,597
|
|
|
13,802
|
|
Total Hyaluronic Acid product and service revenue
|
|
126,568
|
|
|
134,157
|
|
|
142,482
|
|
|
125,668
|
|
|
151,439
|
|
20%
|
|
|
442,344
|
|
|
511,668
|
|
|
277,107
|
|
Cell-Based Therapy
|
|
11,358
|
|
|
10,449
|
|
|
14,080
|
|
|
10,645
|
|
|
11,839
|
|
4%
|
|
|
42,547
|
|
|
45,788
|
|
|
22,484
|
|
Other Biosurgery
|
|
531
|
|
|
394
|
|
|
343
|
|
|
494
|
|
|
300
|
|
(44%)
|
|
|
3,564
|
|
|
1,866
|
|
|
794
|
|
Total Biosurgery product and service revenue
|
|
138,457
|
|
|
145,000
|
|
|
156,905
|
|
|
136,807
|
|
|
163,578
|
|
18%
|
|
|
488,455
|
|
|
559,322
|
|
|
300,385
|
|
R&D revenue
|
|
870
|
|
|
647
|
|
|
414
|
|
|
559
|
|
|
404
|
|
(54%)
|
|
|
2,645
|
|
|
2,493
|
|
|
963
|
|
Total Biosurgery
|
|
139,327
|
|
|
145,647
|
|
|
157,319
|
|
|
137,366
|
|
|
163,982
|
|
18%
|
|
|
491,100
|
|
|
561,815
|
|
|
301,348
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematology and Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mozobil
|
|
11,650
|
|
|
12,896
|
|
|
19,267
|
|
|
18,966
|
|
|
22,141
|
|
90%
|
|
|
639
|
|
|
54,650
|
|
|
41,107
|
|
Thymoglobulin
|
|
53,632
|
|
|
53,412
|
|
|
58,265
|
|
|
52,910
|
|
|
58,232
|
|
9%
|
|
|
183,296
|
|
|
215,964
|
|
|
111,142
|
|
Clolar
|
|
19,708
|
|
|
21,182
|
|
|
22,230
|
|
|
24,688
|
|
|
25,520
|
|
29%
|
|
|
64,044
|
|
|
81,280
|
|
|
50,208
|
|
Other Hematology and Oncology
|
|
26,148
|
|
|
56,096
|
|
|
68,978
|
|
|
59,727
|
|
|
70,597
|
|
>100%
|
|
|
47,120
|
|
|
158,659
|
|
|
130,324
|
|
Total Hematology and Oncology product and service revenue
|
|
111,138
|
|
|
143,586
|
|
|
168,740
|
|
|
156,291
|
|
|
176,490
|
|
59%
|
|
|
295,099
|
|
|
510,553
|
|
|
332,781
|
|
R&D revenue
|
|
852
|
|
|
7
|
|
|
24
|
|
|
19
|
|
|
7
|
|
(99%)
|
|
|
14,439
|
|
|
2,367
|
|
|
26
|
|
Total Hematology and Oncology
|
|
111,990
|
|
|
143,593
|
|
|
168,764
|
|
|
156,310
|
|
|
176,497
|
|
58%
|
|
|
309,538
|
|
|
512,920
|
|
|
332,807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Multiple Sclerosis R&D revenue
|
|
5,066
|
|
|
-
|
|
|
110
|
|
|
-
|
|
|
-
|
|
(100%)
|
|
|
21,709
|
|
|
12,467
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genetics/Diagnostics product and service revenue
|
|
132,955
|
|
|
133,748
|
|
|
142,340
|
|
|
132,582
|
|
|
126,277
|
|
(5%)
|
|
|
477,614
|
|
|
538,237
|
|
|
258,859
|
|
Other product and service revenue
|
|
9,571
|
|
|
3,648
|
|
|
5,137
|
|
|
3,099
|
|
|
3,397
|
|
(65%)
|
|
|
51,473
|
|
|
29,441
|
|
|
6,496
|
|
Total Other product and service revenue
|
|
142,526
|
|
|
137,396
|
|
|
147,477
|
|
|
135,681
|
|
|
129,674
|
|
(9%)
|
|
|
529,087
|
|
|
567,678
|
|
|
265,355
|
|
R&D revenue
|
|
596
|
|
|
582
|
|
|
727
|
|
|
189
|
|
|
367
|
|
(38%)
|
|
|
3,048
|
|
|
2,683
|
|
|
556
|
|
Total Other
|
|
143,122
|
|
|
137,978
|
|
|
148,204
|
|
|
135,870
|
|
|
130,041
|
|
(9%)
|
|
|
532,135
|
|
|
570,361
|
|
|
265,911
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
$
|
1,228,510
|
|
$
|
1,057,514
|
|
$
|
1,080,630
|
|
$
|
1,074,473
|
|
$
|
1,079,439
|
|
(12%)
|
|
$
|
4,605,039
|
|
$
|
4,515,525
|
|
$
|
2,153,912
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
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|
|
|
|
|
|
GENZYME CORPORATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended June 30, 2010
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
(Amounts in thousands, except percentage and per share data)
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER DISCRETE ITEMS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(included in GAAP and Non-GAAP results)
|
|
|
|
|
|
|
|
|
|
Bayer Acquisition Related
|
|
Stock Compensation Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP As Reported
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing Related (2)
|
|
Investment Impairment (3)
|
|
|
|
|
|
|
|
|
NON-GAAP (1)
|
|
|
|
|
|
|
|
|
Income Statement Classification:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
1,079,439
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,079,439
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products and services sold
|
|
$
|
(361,671
|
)
|
|
|
$
|
10,241
|
|
|
$
|
3,975
|
|
|
|
$
|
(347,455
|
)
|
|
|
|
|
|
|
|
$
|
21,970
|
|
|
|
|
|
|
|
Gross margin
|
66
|
%
|
$
|
717,768
|
|
|
|
$
|
10,241
|
|
|
$
|
3,975
|
|
|
68
|
%
|
$
|
731,984
|
|
|
|
|
|
|
|
|
$
|
21,970
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
$
|
(402,535
|
)
|
|
|
|
|
|
|
$
|
26,625
|
|
|
|
$
|
(375,910
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
(225,558
|
)
|
|
|
|
|
|
|
$
|
14,094
|
|
|
|
$
|
(211,464
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles
|
|
$
|
(67,891
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(67,891
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense
|
|
$
|
(10,021
|
)
|
|
|
$
|
10,021
|
|
|
|
|
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in loss of equity method investments
|
|
$
|
(870
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(870
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
$
|
(31,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(31,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
32,250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income
|
|
$
|
3,084
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,084
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
$
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
$
|
(17,229
|
)
|
|
|
$
|
20,262
|
|
|
$
|
44,694
|
|
|
|
$
|
47,727
|
|
|
|
|
|
|
|
|
$
|
21,970
|
|
|
$
|
32,250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Provision for) benefit from income taxes
|
100.14
|
%
|
$
|
17,252
|
|
|
|
$
|
(3,884
|
)
|
|
$
|
(13,452
|
)
|
|
-0.18
|
%
|
$
|
(84
|
)
|
|
|
|
|
|
|
|
$
|
(5,513
|
)
|
|
$
|
(11,893
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
23
|
|
|
|
$
|
16,378
|
|
|
$
|
31,242
|
|
|
|
$
|
47,643
|
|
|
|
|
|
|
|
|
$
|
16,457
|
|
|
$
|
20,357
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.00
|
|
|
|
$
|
0.06
|
|
|
$
|
0.12
|
|
|
|
$
|
0.18
|
|
|
|
|
|
|
|
|
$
|
0.06
|
|
|
$
|
0.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
0.00
|
|
|
|
$
|
0.06
|
|
|
$
|
0.12
|
|
|
|
$
|
0.18
|
|
|
|
|
|
|
|
|
$
|
0.06
|
|
|
$
|
0.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
265,270
|
|
|
|
|
265,270
|
|
|
|
265,270
|
|
|
|
|
265,270
|
|
|
|
|
|
|
|
|
|
265,270
|
|
|
|
265,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
270,125
|
|
|
|
|
270,125
|
|
|
|
270,125
|
|
|
|
|
270,125
|
|
|
|
|
|
|
|
|
|
270,125
|
|
|
|
270,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Represents the Non-GAAP results of operations for Genzyme
Corporation for the three months ended June 30, 2010. 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 primarily write-offs of inventory due to the
interruption in operations late in the first quarter at our Allston,
MA facility, as well as costs associated with the temporary shutdown
at our Haverhill, UK facility in December 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genzyme 2010 Guidance
|
|
($ in millions, except percentages and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Guidance Ranges
|
|
|
|
|
2009 Act
|
|
Low End
|
|
|
|
High end
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerezyme
|
|
|
$793
|
|
|
$725
|
|
|
-
|
|
$775
|
|
|
Fabrazyme
|
|
|
$430
|
|
|
$200
|
|
|
-
|
|
$220
|
|
|
Myozyme
|
|
|
$325
|
|
|
$410
|
|
|
-
|
|
$440
|
|
|
Total PGH (including Cardio)
|
|
|
$1,850
|
|
|
$1,725
|
|
|
-
|
|
$1,765
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synvisc/Synvisc One
|
|
|
$329
|
|
|
$420
|
|
|
-
|
|
$430
|
|
|
Total Biosurgery
|
|
|
$562
|
|
|
$670
|
|
|
-
|
|
$690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renagel/Renvela
|
|
|
$707
|
|
|
$690
|
|
|
-
|
|
$700
|
|
|
Total Renal and Endocrinology
|
|
|
$1,008
|
|
|
$1,040
|
|
|
-
|
|
$1,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Hematology and Oncology (Incl. Thymo)
|
|
|
$513
|
|
|
$710
|
|
|
-
|
|
$740
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other (3)
|
|
|
$583
|
|
|
$265
|
|
|
-
|
|
$265
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL REVENUE
|
|
|
$
|
4,516
|
|
|
$
|
4,410
|
|
|
-
|
|
$
|
4,510
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS MARGIN (1)(2)(3)
|
|
|
|
71
|
%
|
|
|
71
|
%
|
|
-
|
|
|
72
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SG&A (1)(2)(3)
|
|
|
$1,318
|
|
|
$1,325
|
|
|
-
|
|
$1,355
|
|
|
R&D (1)(2)(3)
|
|
|
$804
|
|
|
$855
|
|
|
-
|
|
$875
|
|
|
Amortization
|
|
|
$266
|
|
|
$273
|
|
|
-
|
|
$275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax Rate (1)(2)(3)
|
|
|
|
25
|
%
|
|
|
23
|
%
|
|
|
|
|
24
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GENZ NON-GAAP EPS (1)(2)(3)
|
|
|
$
|
2.27
|
|
|
$
|
1.90
|
|
|
-
|
|
$
|
2.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WTD Average Diluted Shares O/S
|
|
|
|
274
|
|
|
|
263
|
|
|
-
|
|
|
264
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted EPS Impact of Acquisition, Consent Decree and Stock-Based
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation Expenses
|
|
|
|
|
|
|
$1.63
|
|
|
|
|
$1.65
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
This financial guidance, which is provided as part of a press
release dated July 21, 2010, is subject
|
|
|
|
|
|
to all of the qualifications and limitations described therein.
Actual results may differ from these forward-looking
|
|
|
|
|
|
statements due to the numerous factors described in the press
release.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)2009 and 2010 Non-GAAP figures exclude the impact of
acquisition related expenses, consent decree and stock compensation
expense.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2)2009 Non-GAAP figures are reconciled on the 2009 "Genzyme
Corporation Reconciliation of GAAP to Non-GAAP Earnings" schedule
found
|
|
|
on the guidance and reconciliation page within the investors
section at www.genzyme.com
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) Guidance reflects Q1 and Q2 Non-GAAP reported results for
Diagnostics, Genetics, and Pharmaceuticals business units pending
transactions.
|
|
|
|
|
Genzyme 2010 Guidance
|
|
GAAP to Non-GAAP Reconciliations
|
|
($ in millions, except percentages and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected product gross margin GAAP to non-GAAP
|
|
|
|
|
7/21/2010
|
|
|
reconciliation:
|
|
|
|
|
|
|
|
|
|
|
GAAP projected product gross margin
|
|
|
|
|
70% - 71%
|
|
|
Bayer acquisition related - Inventory step up
|
|
|
|
1% - 1%
|
|
|
Non-GAAP projected product gross margin**
|
|
|
|
|
71% - 72%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected selling, general and administrative expenses GAAP to
non-
|
|
|
|
|
|
GAAP reconciliation:
|
|
|
|
|
|
|
|
|
|
GAAP projected selling, general and administrative expenses
|
|
|
$1,600 - $1,640
|
|
|
Stock-based compensation expenses
|
|
|
|
|
$100 - $110
|
|
|
Consent Decree
|
|
|
|
|
|
|
$175 - $175
|
|
|
Non-GAAP projected selling, general and administrative expenses
|
|
$1,325 - $1,355
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected research and development expenses GAAP to non-GAAP
|
|
|
|
|
|
reconciliation:
|
|
|
|
|
|
|
|
|
|
|
GAAP projected research and development expenses
|
|
|
|
$905 - $930
|
|
|
Stock-based compensation expenses
|
|
|
|
|
$50 - $55
|
|
|
Non-GAAP projected research and development expenses
|
|
|
$855 - $875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected diluted EPS impact of acquisition and stock-
|
|
|
|
|
|
|
based compensation expenses:
|
|
|
|
|
|
|
|
|
Bayer acquisition related - Inventory step up
|
|
|
|
|
$0.13 - $0.13
|
|
|
Bayer acquisition-related contingent consideration expense
|
|
|
$0.50 - $0.50
|
|
|
Consent Decree
|
|
|
|
|
|
|
$0.46 - $0.46
|
|
|
Stock-based compensation expenses
|
|
|
|
|
$0.54 - $0.56
|
|
|
Projected diluted EPS impact of acquisition and stock-based
compensation expenses
|
$1.63 - $1.65
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
** Stock-based compensation expenses have a less than one percent
impact on non-GAAP product gross margin.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
This financial guidance, which is provided as part of a press
release dated July 21, 2010, is subject
|
|
|
to all of the qualifications and limitations described therein.
Actual results may differ from these forward-looking
|
|
|
statements due to the numerous factors described in the press
release.
|
|
|
|
Genzyme 2010 Guidance
|
|
($ in millions, except percentages and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 17, 2010 Guidance
|
|
|
|
Supply
|
|
|
|
|
|
F/X
|
|
Health Care Reform
|
|
Pending
|
|
Segment
|
|
July 21, 2010 Guidance
|
|
|
|
|
2009 Act
|
|
Low End
|
|
High end
|
|
|
|
Consent decree
|
|
Volume
|
|
Currency
|
|
U.S.
|
|
Europe
|
|
Transactions
|
|
update
|
|
Low End
|
|
High end
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerezyme
|
|
|
$
|
793
|
|
|
$
|
980
|
|
-
|
$
|
1,037
|
|
|
|
|
|
(175
|
)
|
|
|
-
|
|
|
|
(40
|
)
|
|
|
(3
|
)
|
|
|
(2
|
)
|
|
|
-
|
|
|
|
-
|
|
|
$
|
725
|
|
-
|
$
|
775
|
|
|
Fabrazyme
|
|
|
$
|
430
|
|
|
$
|
360
|
|
-
|
$
|
380
|
|
|
|
|
|
(135
|
)
|
|
|
-
|
|
|
|
(10
|
)
|
|
|
(3
|
)
|
|
|
(2
|
)
|
|
|
-
|
|
|
|
-
|
|
|
$
|
200
|
|
-
|
$
|
220
|
|
|
Myozyme
|
|
|
$
|
325
|
|
|
$
|
470
|
|
-
|
$
|
500
|
|
|
|
|
|
-
|
|
|
|
(15
|
)
|
|
|
(40
|
)
|
|
|
(3
|
)
|
|
|
(2
|
)
|
|
|
-
|
|
|
|
-
|
|
|
$
|
410
|
|
-
|
$
|
440
|
|
|
Total PGH
|
|
|
$
|
1,850
|
|
|
$
|
2,080
|
|
-
|
$
|
2,185
|
|
|
|
|
|
(310
|
)
|
|
|
(10
|
)
|
|
|
(100
|
)
|
|
|
(10
|
)
|
|
|
(8
|
)
|
|
|
-
|
|
|
|
80
|
|
|
$
|
1,725
|
|
-
|
$
|
1,765
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synvisc/Synvisc One
|
|
|
$
|
329
|
|
|
$
|
430
|
|
-
|
$
|
450
|
|
|
|
|
|
-
|
|
|
|
(5
|
)
|
|
|
(5
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
420
|
|
-
|
$
|
430
|
|
|
Total Biosurgery
|
|
|
$
|
562
|
|
|
$
|
690
|
|
-
|
$
|
710
|
|
|
|
|
|
-
|
|
|
|
(15
|
)
|
|
|
(10
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
670
|
|
-
|
$
|
690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renagel/Renvela
|
|
|
$
|
707
|
|
|
$
|
740
|
|
-
|
$
|
770
|
|
|
|
|
|
-
|
|
|
|
(20
|
)
|
|
|
(25
|
)
|
|
|
(6
|
)
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
-
|
|
|
$
|
690
|
|
-
|
$
|
700
|
|
|
Total Renal and Endocrinology
|
|
|
$
|
1,008
|
|
|
$
|
1,095
|
|
-
|
$
|
1,135
|
|
|
|
|
|
(5
|
)
|
|
|
(5
|
)
|
|
|
(30
|
)
|
|
|
(7
|
)
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
(5
|
)
|
|
$
|
1,040
|
|
-
|
$
|
1,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Hematology and Oncology (Incl. Thymo)
|
|
|
$
|
513
|
|
|
$
|
775
|
|
-
|
$
|
810
|
|
|
|
|
|
-
|
|
|
|
(35
|
)
|
|
|
(25
|
)
|
|
|
(2
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
710
|
|
-
|
$
|
740
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other
|
|
|
$
|
583
|
|
|
$
|
680
|
|
-
|
$
|
690
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(5
|
)
|
|
|
(1
|
)
|
|
|
(1
|
)
|
|
|
(336
|
)
|
|
|
(75
|
)
|
|
$
|
265(3)
|
|
-
|
$
|
265(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FX Impact (EURO adjusted 1.50 to 1.40, 2/17/10)
|
|
|
|
-
|
|
|
|
($90
|
)
|
-
|
|
-
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
90
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL REVENUE
|
|
|
$
|
4,516
|
|
|
$
|
5,230
|
|
-
|
$
|
5,530
|
|
|
|
|
$
|
(315
|
)
|
|
$
|
(65
|
)
|
|
$
|
(80
|
)
|
|
$
|
(20
|
)
|
|
$
|
(10
|
)
|
|
$
|
(336
|
)
|
|
$
|
-
|
|
|
|
4,410
|
|
-
|
|
4,510
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS MARGIN (1)(2)(3)
|
|
|
|
71
|
%
|
|
|
71
|
%
|
-
|
|
73
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71
|
%
|
|
|
72
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SG&A (1)(2)(3)
|
|
|
$
|
1,318
|
|
|
$
|
1,510
|
|
-
|
$
|
1,540
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(95
|
)
|
|
|
(90
|
)
|
|
$
|
1,325
|
|
-
|
$
|
1,355
|
|
|
R&D (1)(2)(3)
|
|
|
$
|
804
|
|
|
$
|
945
|
|
-
|
$
|
960
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9
|
)
|
|
|
(81
|
)
|
|
$
|
855
|
|
-
|
$
|
875
|
|
|
Amortization
|
|
|
$
|
266
|
|
|
$
|
320
|
|
-
|
$
|
320
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6
|
)
|
|
|
(41
|
)
|
|
$
|
273
|
|
-
|
$
|
275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax Rate (1)(2)(3)
|
|
|
|
25
|
%
|
|
|
27
|
%
|
|
|
28
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
|
%
|
-
|
|
24
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GENZ NON-GAAP EPS (1)(2)(3)
|
|
|
$
|
2.27
|
|
|
$
|
2.80
|
|
-
|
$
|
3.20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1.90
|
|
-
|
$
|
2.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WTD Average Diluted Shares O/S
|
|
|
|
274
|
|
|
|
272
|
|
-
|
|
274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
263
|
|
-
|
|
264
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted EPS Impact of Acquisition, Consent Decree and Stock-Based
Compensation Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1.63
|
|
-
|
$
|
1.65
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
This financial guidance, which is provided as part of a press
release dated July 21, 2010, is subject
|
|
|
|
|
to all of the qualifications and limitations described therein.
Actual results may differ from these forward-looking
|
|
|
statements due to the numerous factors described in the press
release.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)2009 and 2010 Non-GAAP figures exclude the impact of
acquisition related expenses, consent decree and stock compensation
expense.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2)2009 Non-GAAP figures are reconciled on the 2009 "Genzyme
Corporation Reconciliation of GAAP to Non-GAAP Earnings" schedule
found
|
|
on the guidance and reconciliation page within the investors
section at www.genzyme.com
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) Guidance reflects Q1 and Q2 Non-GAAP reported results for
Diagnostics, Genetics, and Pharmaceuticals business units pending
transactions.
|
Contacts
Genzyme Corp. Media: Erin
Emlock, 617-768-6923 or Investors: Patrick
Flanigan, 617-768-6563
|
|