Reiterates Outlook for Strong and Sustainable Growth
CAMBRIDGE, Mass., Jan. 8 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that revenue rose 21 percent in the fourth
quarter of 2007 to $1.04 billion, up from $854 million in the fourth
quarter a year earlier. For the year, revenue grew 20 percent to $3.8
billion from $3.2 billion in the previous year.
Genzyme reported these and other preliminary, unaudited figures in
conjunction with a presentation by Chairman and Chief Executive Officer
Henri A. Termeer at the JPMorgan 26th Annual Healthcare Conference in San
Francisco. The company will report full financial results for 2007 on
February 13.
Mr. Termeer today reiterated Genzyme's outlook for strong growth and
outlined a set of five-year performance goals for the company:
-- Genzyme is committed to growing non-GAAP earnings by a compound average
of 20 percent from 2006-2011. Non-GAAP earnings are projected to
increase to approximately $4.00 per diluted share in 2008 and to rise
to approximately $7.00 per diluted share by 2011.
-- Genzyme expects to drive this profit growth through strong sales and
increasing operating leverage. Revenue is projected to grow over this
five-year period by a compound average of 16-17 percent while gross
margin and SG&A leverage will provide an improvement of 300-400 basis
points on the bottom line.
-- Genzyme plans to continue to expand its pipeline to support its growth
beyond 2011. The company took a major step forward yesterday by
licensing from Isis Pharmaceuticals Inc. the potential blockbuster
mipomersen, a breakthrough lipid-lowering product currently in phase 3
clinical trials for high-risk cardiovascular disease patients. This
transaction helps transform Genzyme's already strong and diverse
pipeline.
Genzyme expects to achieve these performance goals through a proven
business model that has driven the company's development and produced
compound average earnings growth exceeding 20 percent over the past decade.
This model is based on a defining corporate mission that focuses on
patients; a portfolio of high-value, targeted products that are defining
and leading their markets by addressing serious unmet needs; a global
commercial and manufacturing infrastructure that is creating operating
leverage; and a diversified approach that enables opportunities while
reducing risks.
This model also positions Genzyme to capture the significant
opportunities inherent in the rapidly evolving health care environment.
Genzyme's focus on innovative, paradigm-changing products for
well-identified patient populations, its capacity to link therapeutics with
diagnostics, and its ability to reach markets throughout the world will
enable the company to sustain its leadership and growth over the longer
term.
"We are in a very strong position to execute our growth plan," said Mr.
Termeer. "We are on track to deliver 20 percent earnings growth through
2011, and we feel bullish as we look ahead at the picture that is unfolding
for Genzyme."
Genzyme has established a leadership position in the treatment of
lysosomal storage disorders. Within this field, the company has
successfully introduced four enzyme replacement therapies globally. The
launch of the newest of these, Myozyme(R) (alglucosidase alfa), has been
the most rapid for any of the four products. Myozyme sales more than
doubled in the fourth quarter, rising to $62 million from $30 million in
the previous fourth quarter. Myozyme sales in 2007 reached $201 million,
more than three times greater than first-year sales of $59 million in 2006.
In December, Genzyme announced that its post-marketing Late-Onset Treatment
Study of Myozyme met its co-primary endpoints, confirming the benefit of
the product for patients across the spectrum of Pompe disease.
Fourth-quarter sales of Fabrazyme(R) (agalsidase beta) were $114
million, up 18 percent from $97 million in the same quarter a year ago. For
the year, sales grew 18 percent to $424 million, compared with $359 million
in the previous year. Fabrazyme has captured more than two thirds of the
international market for Fabry disease treatments, surpassing its
competitor based on compelling clinical data and an established global
regulatory and commercial organization. The European Committee for
Medicinal Products for Human Use has issued a positive opinion to grant
full marketing authorization to Fabrazyme, which was approved originally
under exceptional circumstances. If the European Commission supports this
opinion, Fabrazyme would become the only treatment for Fabry disease with
full marketing authorization in Europe, as well and the first orphan
designated medicinal product to achieve this status after receiving
approval under exceptional circumstances.
Fourth-quarter sales of Cerezyme(R) (imiglucerase for injection) were
$301 million, 15 percent greater than sales of $262 million in the fourth
quarter a year ago. For the year, sales were $1.1 billion, up 13 percent
from $1.0 billion the year before. Genzyme is investing in the development
of an innovative, next-generation product for the treatment of Gaucher
disease. The company has completed enrollment in a phase 2 trial of the
small molecule Genz-112638, a novel oral therapy that could provide an
additional treatment option for physicians and patients. Initial results
for the first group of participants enrolled in the study were encouraging,
and one-year data for all patients will be available this year.
Sales of Aldurazyme(R) (laronidase) were $34 million in the fourth
quarter, compared with $26 million in the same quarter a year ago. For the
year, Aldurazyme sales were $122 million, 26 percent greater than sales of
$96 million in the previous year. Under a restructured joint venture with
BioMarin Pharmaceutical Inc., Genzyme will now record sales of Aldurazyme
and pay BioMarin a tiered payment on worldwide product sales. Payments are
projected to result in both BioMarin and Genzyme receiving approximately
the same profit split as under the original joint venture structure.
Sales of Thyrogen(R) (thyrotropin alfa for injection) grew 26 percent
in the fourth quarter to $31 million, compared with $25 million in the
period a year ago. For the year, Thyrogen revenue grew 21 percent to $114
million, up from $94 million the year before. Genzyme received U.S.
approval in December for Thyrogen's use in thyroid cancer remnant ablation
procedures.
The lysosomal storage disorder segment has formed the core of Genzyme's
business to date, and the growth potential for this segment remains strong.
Genzyme expects sales of lysosomal storage disorder products to grow at a
compound average of approximately 13 percent over the five-year period from
2006-2011. At the same time, the emerging segments of Genzyme's portfolio
are expected to make an increasingly greater contribution to the company's
growth, underscoring the beneficial impact of diversification. Revenue from
these emerging segments is expected to grow at compound average of
approximately 19 percent.
Leading these emerging segments is Genzyme's Renal franchise, which is
on track to generate more than $1 billion annually by 2011, driven by the
sustained growth of the company's sevelamer therapies Renagel(R) (sevelamer
hydrochloride) and Renvela(R) (sevelamer carbonate). The increasing use of
these products globally and the anticipated expansion of Renvela's
indication to include the treatment of patients with chronic kidney disease
are expected to act as the principal catalysts for the growth of this
franchise, which has been built on a mounting body of clinical evidence
supporting the range of benefits of sevelamer therapy.
Sales of Renagel rose 23 percent in the fourth quarter of 2007 to $167
million, compared with $135 million in the previous fourth quarter. For the
year, Renagel sales increased 17 percent to $603 million, compared with
$515 million the year before. Renvela was approved by the FDA in October
for the treatment of hemodialysis patients, and Genzyme expects to launch
the product this quarter. The company expects to seek FDA approval in the
first half of this year for the product's use by patients with chronic
kidney disease who have not progressed to dialysis.
Genzyme's Biosurgery franchise is expected to generate annual sales
approaching $1 billion by 2011. The growth of this franchise will be driven
by the introduction of the single-injection regimen Synvisc-One(TM), which
has the potential to redefine the market for viscosupplementation products
and expand the benefits of this therapeutic approach to a broader set of
patients by simplifying osteoarthritis pain management. Synvisc-One was
approved in the European Union in December, and action on a marketing
application in the United States is expected later this year.
Fourth-quarter sales of Synvisc(R) (hylan G-F 20) were $63 million,
compared with sales of $61 million in the same quarter a year ago. For the
year, Synvisc sales were $242 million, compared with $234 million in the
previous year.
Also driving the growth of the Biosurgery franchise is the Sepra(R)
family of products. Sales of Sepra products rose 29 percent to $30 million
in the fourth quarter, up from $23 million in last year's fourth quarter.
For the year, sales rose 22 percent to $105 million compared with $85
million in the previous year. This growth reflects the increasing use of
Seprafilm(R) adhesion barrier in larger markets such as gynecologic
surgery. Genzyme's expanded U.S. Sepra sales force is helping to broaden
use of the product.
Genzyme's Transplant franchise is expected to contribute nearly $500
million in revenue annually by 2011. The growth of this franchise will be
driven by the anticipated introduction of Mozobil(R) (plerixafor) and the
planned global expansion of Thymoglobulin(R) (anti-thymocyte globulin,
rabbit). Sales of Thymoglobulin increased 12 percent in the fourth quarter
to $44 million, up from $39 million during the same quarter last year. For
the year, sales were $166 million, 11 percent greater than $150 million in
the previous year.
Genzyme's Oncology franchise is expected to generate approximately $500
million annually by 2011, driven by the use of Clolar(R) (clofarabine) as a
first-line therapy for adult acute myeloid leukemia, the use of Campath(R)
(alemtuzumab) as a first-line treatment for B-cell chronic lymphocytic
leukemia, and the expansion of these products in markets outside of the
United States and Europe. Genzyme's Oncology revenue increased 51 percent
in the fourth quarter to $26 million, up from $17 million in the fourth
quarter a year ago. For the year, Oncology revenue rose 48 percent to $88
million compared with $59 million the year before.
Genzyme's Genetics franchise is expected to generate revenue of nearly
$500 million annually by 2011, driven by growth in oncology and
reproductive testing. This business is also playing an important role in
the development of 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. In the fourth
quarter, Genetics revenue rose 19 percent to $73 million, compared with $61
million in the prior fourth quarter. Revenue increased 20 percent for the
year, rising to $286 million from $241 million in the year earlier.
Genzyme is investing in the development of new therapeutic products to
address major unmet medical needs and support its long-term growth. The
company continues to build its pipeline through both internal research and
licensing and acquisitions, focusing on product candidates with the
potential to change the standard of care for serious diseases. The
company's pipeline is concentrated on programs in mid- to late-stage
development and includes more than 25 phase 2 studies and several major
pivotal studies. Three programs stand at the forefront:
Mipomersen
Genzyme has entered into major strategic alliance with Isis
Pharmaceuticals, in which Genzyme will develop and commercialize
mipomersen. Currently in phase 3 development, mipomersen has been shown in
phase 2 trials to reduce cholesterol and other atherogenic lipids more than
40 percent beyond reductions achieved with current standard lipid lowering
drugs, enabling most patients to achieve lipid targets. These trials have
shown that the treatment is well-tolerated, has a strong safety profile,
and it works equally well in the presence and absence of other lipid
lowering therapies including statins. A weekly injectable therapeutic,
mipomersen is being developed primarily for patients at significant
cardiovascular risk who are unable to achieve target cholesterol levels
with statins alone or who are intolerant of statins.
Mipomersen's initial indication will be for patients with familial
hypercholesterolemia (FH), with an anticipated filing in 2009. There are
approximately 1.5 million people in the United States and Europe with FH,
an inherited disorder that causes exceptionally high levels of
LDL-cholesterol. After appropriate clinical development, the next
indication planned for mipomersen will be for other patients with high
cholesterol at high risk of cardiovascular events.
Mipomersen offers an innovative approach to addressing a real, unmet
medical need, and Genzyme believes it could prove to be the most effective
lipid-lowering agent for high risk cardiovascular disease patients for whom
conventional therapies are not sufficient. The product may potentially
provide significant benefit over the standard of care and targets a well-
defined and severely ill patient population.
Alemtuzumab
Genzyme and Bayer Schering Pharma AG, Germany, have begun enrolling
patients in two phase 3 trials examining the safety and efficacy of
alemtuzumab (Campath) for the treatment of multiple sclerosis. One study
includes previously untreated patients and one involves patients whose
disease remains active following treatment with an approved therapy.
In October 2007, Genzyme reported top-line three-year results from a
completed phase 2 clinical trial comparing alemtuzumab with Rebif(R)
(interferon beta-1a) for the treatment of multiple sclerosis. The study
showed that patients taking alemtuzumab experienced at least a 73 percent
reduction in the risk for relapse and at least a 70 percent reduction in
the risk for progression of clinically significant disability after three
years of follow up when compared to patients treated with interferon
beta-1a. The data also showed that mean disability scores improved from
baseline in the alemtuzumab patients and declined in the Rebif patients.
Alemtuzmab is administered in one multi-day cycle per year, which may
offer a significantly more convenient option for patients who currently
manage multiple injections each week.
Alemtuzumab's effect in treating MS, observed in clinical studies,
exceeds that of any currently marketed products and any products in
development. Genzyme believes that alemtuzumab has the potential to be the
best therapy in a market for MS drugs that is projected to reach $8-9
billion annually when the treatment is expected to be ready for launch in
2011-2012.
Mozobil
Mozobil is an innovative product intended to facilitate and improve the
outcome of stem-cell transplantation procedures by rapidly and effectively
increasing the number of stem cells circulating in the blood. In two
pivotal clinical studies, Mozobil showed the ability to quickly and
predictably prepare cancer patients for a transplant to treat their
disease. Specifically, patients who received Mozobil achieved more rapid
and effective mobilization of stem cells in preparation for transplant than
patients treated with current therapies. Results from these studies were
presented at the American Society of Hematology annual meeting in December.
Genzyme plans to file in the first half of this year for U.S. and
European approval for the product's use in treating patients with multiple
myeloma and patients with lymphoma. The company plans to launch the product
early next year upon approval. Genzyme expects peak sales of Mozobil in the
transplant setting of $400 million, and the company is exploring additional
indications for the product, including its near-term potential use in
chemosensitization procedures.
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 10,000 employees in locations
spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
In 2006 and 2007, Genzyme was 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 nearly
90 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 diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
This press release contains forward-looking statements regarding
Genzyme financial outlook and business plans and strategies, including
without limitation: its anticipated compound average earnings growth rate
from 2006- 2011; its 2008 and 2011 EPS guidance; its projected revenue
growth for the company and for certain businesses, including the LSD,
Renal, Biosurgery, Transplant, Oncology and Genetics businesses, as well as
the anticipated drivers of such revenue growth; its anticipated gross
margin and SG&A growth rates; its plans to seek regulatory approvals of
existing products for use in new indications, including Renvela, Campath
(alemtuzumab) and Clolar, the timetables therefore and the estimated market
potential of such products; its plans and estimated timetables for new and
next-generation product approvals and launches, including for Mozobil,
Synvisc-One, and mipomersen; its plans to expand its pipeline to help
achieve projected growth; its assessment of the potential of certain
product candidates, including alemtuzumab-MS, Mozobil and mipomersen; and
its 2007 unaudited revenues. These statements are subject to risks and
uncertainties that could cause actual results to differ materially from
those forecasted. These risks and uncertainties include, among others:
Genzyme's ability to successfully complete preclinical and clinical
development of its products; Genzyme's ability to expand the use of current
products in existing and new indications; Genzyme's ability to obtain and
maintain regulatory approvals for products and manufacturing facilities,
including the larger-scale production of Myozyme and the timing of receipt
of such approvals; Genzyme's ability to manufacture products and product
candidates in a timely and cost effective manner and in sufficient
quantities to meet demand; Genzyme's ability to maintain and enforce
intellectual property rights; Genzyme's ability to successfully identify
and market to new patients; the scope of third-party reimbursement coverage
for Genzyme's products and services; 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 Genzyme's Quarterly Report on Form 10-Q for the period ended September
30, 2007. Genzyme cautions investors not to place substantial reliance on
the forward-looking statements contained in this press release. These
statements speak only as of today's date and Genzyme undertakes no
obligation to update or revise the statements.
Genzyme(R), Myozyme(R), Fabrazyme(R), Cerezyme(R), Thyrogen(R),
Renagel(R), Renvela(R), Thymoglobulin(R), Mozobil(R), Synvisc(R), Sepra(R),
Seprafilm(R), Campath(R) and Clolar(R) are registered trademarks and
Synvisc- One(TM) is a trademark of Genzyme Corporation or its subsidiaries.
Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC. All rights
reserved.
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 1-678-999-4572 outside the
United States.
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 15, 2008.
Upcoming Events
On February 13, 2008, Genzyme will report its financial results for the
fourth quarter of 2007 and financial guidance for 2008. There will be a
conference call at 11:00 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 203-369-1503. This call will also be Webcast
live on the investor events section of http://www.genzyme.com. Replays of the call
and the Webcast will be available until midnight February 20, 2008.
Media Contact: Investor Contact:
Bo Piela Sally Curley
(617) 768-6579 (617) 768-6140
SOURCE Genzyme Corp.
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CONTACT:
Media Contact, Bo Piela, +1-617-768-6579, or
Investor Contact, Sally Curley, +1-617-768-6140, both of Genzyme
Corp.
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