Company Expects 2007 Revenue of $3.6-$3.8 Billion Non-GAAP EPS of
$3.10-$3.20
CAMBRIDGE, Mass., Jan. 9 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that revenue increased 17 percent in the
fourth quarter of 2006 to $852 million, up from $729 million in the fourth
quarter a year earlier. For the year, revenue grew 16 percent to $3.2
billion from $2.7 billion in the previous year.
Genzyme reported these and other preliminary, unaudited revenue figures
today in conjunction with a presentation by Chairman and Chief Executive
Officer Henri A. Termeer at the JPMorgan 25th Annual Healthcare Conference
in San Francisco. The company will report full financial results for 2006
on February 14.
"Record top-line results in the fourth quarter culminated a year that
truly demonstrated the sustainability of our business," said Mr. Termeer.
"It was also a year in which we set the stage for future growth by further
building our commercial and manufacturing infrastructure and by advancing
or completing many late-stage clinical trials. During the coming year, we
expect to report results from approximately ten pivotal studies and to push
forward with efforts to introduce new products that promise to change the
clinical picture for a number of devastating diseases."
Genzyme also reported today that it expects 2007 revenue of $3.6-$3.8
billion and non-GAAP earnings of $3.10-$3.20 per share. This earnings
estimate does not reflect the impact of the company's fourth-quarter
acquisition of AnorMED Inc. because the accounting for that transaction has
not been completed. Genzyme intends to provide earnings estimates that
reflect the impact of the AnorMED acquisition on Feb. 14 when it provides
more detailed financial guidance with its audited 2006 results. Non-GAAP
estimates also exclude amortization and stock-compensation expenses, along
with the dilutive impact of contingent convertible debt.
Genzyme's performance in 2006 caps a six-year period in which sales
have increased at a compound annual rate of approximately 27 percent,
driven by the company's strategy to diversify its product portfolio and
further extend its global reach. During this period, Genzyme's reliance on
its first product, Cerezyme(R), to sustain its growth has decreased
markedly. Cerezyme sales in 2006 represented 32 percent of all revenue,
down from 71 percent in 2000. Moreover, Genzyme's international sales from
2000-2005 increased at a compound annual rate of 31 percent, compared with
a 28 percent rate for U.S. sales, underscoring the benefit of the company's
investment in its global infrastructure.
Genzyme's diverse set of products and its commitment to operate in a
broad range of global markets provide a platform for consistent and
sustainable future growth. Based on the growth of its current marketed
products alone, the company expects its annual revenue to approximately
double over the next five years. Behind these products is a robust
late-stage pipeline of potential new therapies. This year, Genzyme expects
to initiate, conduct or complete 20 pivotal trials for new products or new
indications to further expand and diversify its portfolio and contribute to
its longer-term growth.
Genetic Diseases
Genzyme now markets treatments for four lysosomal storage disorders.
Last year, the company obtained approval for Myozyme(R) (alglucosidase
alfa), the first product ever developed for Pompe disease, a progressive,
debilitating and often fatal neuromuscular disorder. Myozyme is off to a
strong start. It was launched in Europe and the United States during the
second quarter of 2006, and more than 550 patients in approximately 35
countries are currently on therapy. Sales grew significantly in the fourth
quarter, increasing to $30 million. This year, Genzyme expects to launch
Myozyme in Japan, Brazil and a number of additional markets. Myozyme
recently received the prestigious Panorama del Medicamento award as the
most innovative drug of 2006 in Spain, as deemed by the National
Pharmaceutical Council, the highest professional body of Spanish
pharmacists. In September, Myozyme earned the 2006 UK Prix Galien Gold
Medal, presented bi-annually to new products judged to be the most
innovative.
Results from the pivotal clinical trial of Myozyme were published last
month in Neurology. Results from the ongoing study of Myozyme involving
patients with late-onset Pompe disease are expected later this year and
will be submitted to regulatory authorities in 2008. The 90-patient trial
is intended to provide further support for Myozyme's use. Using an
innovative adaptive design procedure, the duration of this trial has been
extended for six months and will now end this fall when all patients will
have completed 18 months of treatment.
Fourth-quarter sales of Fabrazyme(R) (agalsidase beta) for Fabry
disease were $96 million, up 18 percent from $82 million in the same
quarter a year ago. For the year, Fabrazyme sales grew 18 percent to $359
million, compared with $305 million in the previous year. More than 1,900
patients in approximately 45 countries are currently treated with
Fabrazyme. Results from the Phase 4 clinical trial of Fabrazyme were
published last month in Annals of Internal Medicine. The trial showed that
Fabrazyme reduced the risk of major clinical events that cause death and
disability in Fabry disease. It is the only major outcomes study to be
conducted involving Fabry patients.
Fourth-quarter sales of Cerezyme(R) (imiglucerase for injection) enzyme
replacement therapy for Type 1 Gaucher disease were $262 million, 13
percent greater than sales of $232 million in the fourth quarter a year
ago. For the year, Cerezyme sales were $1.0 billion, up 8 percent from $932
million the year before. More than 4,800 patients in approximately 90
countries are currently receiving Cerezyme.
Sales of Aldurazyme(R) (laronidase) enzyme replacement therapy for MPS
I were $27 million in the fourth quarter, compared with $21 million in the
same quarter a year ago. For the year, Aldurazyme sales were $96 million,
compared with sales of $76 million in the previous year. Aldurazyme is
marketed through a joint venture with BioMarin Pharmaceutical Inc., and
product sales are not included in Genzyme's revenue figures. More than 500
patients in approximately 40 countries are currently receiving Aldurazyme.
The product was approved in Japan during the fourth quarter.
Sales of Thyrogen(R) (thryotropin alfa for injection) increased 18
percent in the fourth quarter to $25 million, compared with $21 million in
the same period a year ago. For the year, Thyrogen sales rose 21 percent to
$94 million from $78 million in the previous year.
Renal
Within the Renal business, Genzyme markets Renagel(R) (sevelamer
hydrochloride), a phosphate binder for patients with end-stage renal
disease on hemodialysis, and Hectorol(R) (doxercalciferol), a line of
Vitamin D2 products for secondary hyperparathyroidism in dialysis patients
and those with earlier stages of chronic kidney disease.
Fourth-quarter revenue for Renagel grew 22 percent to $135 million,
compared with $110 million in the same quarter a year ago. For the year,
revenue grew 23 percent to $515 million, compared with $417 million in the
previous year. More than 350,000 patients in approximately 50 countries are
currently treated with Renagel. The product's growth is being driven by a
number of factors, including the communication of data highlighting the
clinical and economic benefits of the product. Results from the RIND study
published this month in Kidney International showed that patients using
Renagel experienced a significantly lower rate of death compared with
patients using calcium-based phosphate binders. At the American Society of
Nephrology meeting in November, investigators presented three-year
hospitalization and health economic data from the DCOR study showing that
patients using Renagel experienced lower rates of hospitalization, fewer
days in the hospital, and reduced overall health care expenditures compared
to patients treated with calcium-based phosphate binders.
The development of sevelamer carbonate, a next-generation version of
Renagel, took a major step forward in the fourth quarter when Genzyme
submitted a New Drug Application to the FDA seeking approval of sevelamer
carbonate for the control of serum phosphorus in patients with chronic
kidney disease on dialysis. Genzyme expects to launch the product
commercially in 2008 under the trade name Renvela(TM). Following the
anticipated approval of Renvela, Genzyme plans to submit a supplemental NDA
seeking marketing approval for the product's use in treating
hyperphosphatemic patients with chronic kidney disease who are not on
dialysis. The company also intends to seek approval for a powder form of
Renvela taken once per day, which would provide patients with a more
convenient formulation and dosing schedule that could help improve
compliance.
Hectorol sales were $27 million in the fourth quarter, 30 percent
greater than sales of $20 million in the same quarter a year ago. For the
year, Hectorol sales were $93 million. Genzyme began selling Hectorol in
mid-2005 following its acquisition of Bone Care International. More than
85,000 patients are currently being treated with Hectorol in the United
States. Genzyme is working to register the product globally.
Biosurgery
Fourth-quarter sales of Synvisc(R) (hylan G-F 20) were $60 million,
compared with sales of $58 million in the same quarter a year ago. For the
year, Synvisc sales were $233 million, compared with $219 million in the
previous year. Synvisc is a market-leading viscosupplement used to treat
pain caused by osteoarthritis of the knee. Last month, the Centers for
Medicare and Medicaid Services preserved a separate reimbursement code and
rate for Synvisc for 2007, reversing an earlier decision that would have
assigned a single reimbursement code to all viscosupplement products.
This action not only maintains the current reimbursement structure for
Synvisc, but also continues to encourage innovation in the field. Genzyme
has invested in developing potential next-generation approaches to
viscosupplementation to reduce the burden of treatment and overall cost of
therapy. In December, the company reported preliminary results from a study
showing that patients who received Synvisc through a single-injection
regimen achieved a statistically significant improvement in pain from
osteoarthritis of the knee over 26 weeks compared with those using placebo.
Currently Synvisc is delivered through three injections given at one-week
intervals. Genzyme plans in the first half of this year to request an
amendment to the Synvisc product label in the United States and Europe to
include a single- injection regimen, which would significantly improve the
product's ability to compete with products requiring a greater number of
injections.
Sales of Sepra(TM) anti-adhesion products were $23 million in the
fourth quarter, 31 percent greater than $17 million in the fourth quarter a
year ago. For the year, sales of Sepra products were $85 million, an
increase of 25 percent compared with $68 million a year earlier.
Transplant
Within the Transplant area, combined sales of Thymoglobulin(R) (anti-
thymocyte globulin, rabbit) and Lymphoglobuline(R) (anti-thymocyte
globulin, equine) increased 14 percent in the fourth quarter to $39
million, up from $35 million during the same period last year. For the
year, sales were $149 million, 17 percent greater than $128 million in the
previous year.
Diagnostics/Genetics
Total revenue for the Diagnostics/Genetics business increased to $93
million in the fourth quarter, up 8 percent compared with $86 million in
the fourth quarter a year ago. For the year, revenue was $356 million, up 9
percent compared with $327 million a year ago. This year, Genzyme
introduced six new personalized medicine tests, which are designed to
provide physicians and patients with critical information to help determine
how patients are likely to respond to targeted therapies.
Other revenue-including oncology revenue, sales of pharmaceutical
intermediates, R&D revenue, and royalties from the sale of WelChol(R)
(colesevelam hydrochloride)-was $44 million in the fourth quarter, 19
percent greater than $37 million in the same quarter last year. For the
year, other revenue was $158 million, a 17 percent increase from $135
million in the previous year.
Oncology
Oncology revenue was $17 million in the fourth quarter, an increase of
44 percent compared to $12 million in the same period last year. For the
year, oncology revenue was $59 million, 31 percent greater than $45 million
for the previous year. Oncology revenue includes profits and royalties from
Campath(R) (alemtuzumab for injection), which is marketed by Schering AG
and its U.S. affiliate Berlex; sales of Clolar(R) (clofarabine for
intravenous infusion); and R&D revenue.
Genzyme is working to broaden the indications for Campath and Clolar to
benefit larger patient populations. Data from the CAM 307 trial presented
at the annual American Society of Hematology meeting demonstrated that
Campath significantly improved progression-free survival in comparison to
chlorambucil in previously untreated patients with B-cell chronic
lymphocytic leukemia, with Campath reducing the risk of disease progression
or death by 42 percent. Campath received accelerated U.S. approval in 2001,
and CAM307 was the primary post-approval commitment study designed to
support full approval. Campath is currently indicated for the treatment of
B-CLL in patients who have been treated with alkylating agents and who have
failed fludarabine therapy. Genzyme and Schering AG expect to submit U.S.
and European applications this year to expand the product's current label
to include first-line treatment of B-CLL patients.
Genzyme is seeking to expand Clolar's indication to include adult
patients with acute myelogenous leukemia (AML). The product is currently
indicated for the treatment of pediatric patients with relapsed or
refractory acute lymphoblastic leukemia after at least two prior regimens.
In November, Genzyme began a trial examining the safety and effectiveness
of Clolar in previously untreated, older adult patients with AML who are
unlikely to benefit from standard induction therapy. This was the second
pivotal clinical study of clofarabine in adult patients with AML to begin
last year, and it is expected to provide substantial support for expanding
the current product label.
Additional Pipeline Highlights
* Results from the phase 3 trial of tolevamer are expected to be
available during the second half of this year. Pending a positive outcome,
the first commercial approval is anticipated in 2008. Tolevamer is a novel
polymer therapy that could be the first non-antibiotic treatment for
Clostridium difficile-associated diarrhea, a widespread and growing global
problem primarily affecting patients in hospitals and nursing homes. The
prevalence and impact of Clostridium difficile are becoming increasingly
more visible as public health officials and others look for new ways to
manage this disease.
* Following an encouraging meeting with the FDA in November, Genzyme
expects to initiate during the first half of this year a phase 3 study of
alemtuzumab (Campath) for the treatment of relapsing/remitting multiple
sclerosis. The company is currently developing the study protocol to submit
to the agency for review. Two-year results from a pre-planned interim
analysis of the three-year phase 2 study were released in September and
showed a robust, statistically significant treatment effect for alemtuzumab
compared with Rebif(R) (interferon beta-1a). The IND for this trial remains
on clinical hold in the United States, and Genzyme is working closely with
clinical investigators and regulatory agencies to complete the study and
ensure that the risk of immune thrombocytopenic purpura (ITP) is well
understood and managed. Genzyme has implemented a comprehensive risk
management plan to help physicians and patients participating in the trial
detect ITP early and minimize the risk of complications.
* Through its November 2006 acquisition of AnorMED, Genzyme obtained a
promising new product candidate, Mozobil(TM) (plerixafor) for use in stem
cell transplantation procedures. Mozobil is an experimental product in
late-stage clinical development that is designed to improve the outcome of
stem cell transplantation in patients with blood cancers. Enrollment is
complete in a pivotal Phase 3 trial for Mozobil in multiple myeloma and a
second pivotal Phase 3 trial in non-Hodgkin's lymphoma. Results from both
studies are expected in mid-2007.
* In the lysosomal storage disease area, enrollment is continuing in an
international, multi-center phase 2 clinical trial evaluating the safety
and efficacy of the small molecule GENZ-112638 for the treatment of Gaucher
disease. The trial will help determine the potential of this compound as an
alternative or adjunct to enzyme replacement therapy. GENZ-112638 also may
be applicable to several other lysosomal storage disorders in addition to
Gaucher disease. Initiation of the phase 2 program follows completion of an
extensive pre-clinical research effort and a phase 1 program that involved
more than 120 subjects in three separate studies.
* Genzyme and partner Dyax Corp. have completed the double-blind
portion of the Phase 3 clinical trial known as EDEMA3 for DX-88
(ecallantide) for the treatment of hereditary angioedema (HAE). The second
phase of the study, which continues to treat patients, allows for
open-label DX-88 to be administered for acute attacks. Results from the
study are expected to be available in the first half of this year.
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 9,000 employees in locations
spanning the globe and preliminary, unaudited 2006 revenues of $3.2
billion. Genzyme has been selected by FORTUNE as one of the "100 Best
Companies to Work for" in the United States.
With many established products and services helping patients in more
than 80 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 diseases, and diagnostic
testing. Genzyme's commitment to innovation continues today with a
substantial development program focused on these fields, as well as heart
disease and other areas of unmet medical need.
This press release contains forward-looking statements, including
statements regarding: 2006 unaudited revenues; 2007 revenue and earnings
estimates; plans for the launch of Myozyme in Japan, Brazil and additional
markets and the timing thereof; plans for Renvela, including anticipated
approval, launch timing and label scope; plans to seek approval of a
single- injection administration of Synvisc and the timing thereof; plans
for tolevamer, including timing of commercial launch; the initiation of a
phase 3 trial of alemtuzumab for MS and the timing thereof; plans to expand
the use of Campath and Clolar into earlier-line and additional indications;
2011 revenue estimates; the timing of the receipt of clinical trial data
for Myozyme, tolevamer, Mozobil and DX-88; expectations regarding the
number of pivotal trials initiated, conducted or completed in 2007; as well
as other statements regarding Genzyme's future performance and strategy.
These statements are subject to risks and uncertainties that could cause
actual results to differ materially from those forecast in these
forward-looking statements. These risks and uncertainties include, among
others, Genzyme's ability to successfully complete preclinical and clinical
development and post-marketing commitments for its products and services;
Genzyme's ability to expand the use of current products in existing and new
indications and geographic areas; the content and timing of actual
submissions to and decisions made by the FDA, EMEA and other regulatory
agencies; Genzyme's ability to successfully identify and market to new
patients; the availability of reimbursement for Genzyme's products and
services, including Synvisc, the extent of that coverage and the accuracy
of Genzyme's estimates of the payor mix; 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 "Factors
Affecting Future Operating Results" in Genzyme's Quarterly Report on Form
10-Q for the period ended September 30, 2006. Genzyme cautions investors
not to place substantial reliance on the forward-looking statements
contained in this press release. These statements speak only as of January
9, 2007, and Genzyme undertakes no obligation to update or revise the
statements.
Genzyme(R), Cerezyme(R), Myozyme(R), Fabrazyme(R), Aldurazyme(R),
Thyrogen(R), Renagel(R), Hectorol(R), Synvisc(R), Campath(R), Clolar(R),
Thymoglobulin(R) and Lymphoglobuline(R) are registered trademarks, and
Renvela(TM), Mozobil(TM), and Sepra(TM) are trademarks of Genzyme
Corporation or its subsidiaries. WelChol(R) is a registered trademark of
Sankyo Pharma Inc. All rights reserved.
This press release includes certain non-GAAP financial measures that
involve adjustments to GAAP figures. Genzyme believes that these non-GAAP
financial measures, when considered together with the GAAP figures, can
enhance an overall understanding of Genzyme's past financial performance
and its prospects for the future. The non-GAAP financial measures are
included with the intent of providing both management and investors with a
more complete understanding of underlying operational results and trends.
In addition, these non-GAAP financial measures are among the primary
indicators Genzyme management uses for planning and forecasting purposes.
These non-GAAP financial measures are not intended to be considered in
isolation or as a substitute for GAAP figures.
Webcast Information
Mr. Termeer's presentation will be Webcast live at 12:00 p.m. Eastern
Time on the investor events section of http://www.genzyme.com. A replay of the
presentation will be available immediately and will be accessible until
January 16, 2007.
Upcoming Events
On February 14, 2007, Genzyme will announce its financial results for
the fourth quarter of 2006 and financial guidance for 2007. There will be a
conference call at 11:00 a.m. Eastern. If you would like to participate in
the call, please dial (706) 679-8722. This call will also be Webcast on the
investor events section of http://www.genzyme.com. A replay of the Webcast and
call will be available from 2:15 p.m. Eastern through midnight on February
21, 2007. For the replay, please dial (706) 645-9291 and refer to
reservation number 4245727.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line at
1-800-905-4369 within the United States or 1-703-797-1866 outside the
United States.
Media Contact: Investor Contact:
Bo Piela Sally Curley
(617) 768-6579 (617) 768-6140
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
CONTACT:
Media, Bo Piela, +1-617-768-6579, or
Investors, Sally Curley, +1-617-768-6140, both of Genzyme Corp.
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