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Preclinical
Phase 1
Phase 2
Phase 3
BLA/NDA/MAA
On The Market
Naglazyme for MPS VI
Aldurazyme for MPS I
Orapred ODT for Inflammatory Conditions
Phenoptin for PKU
6R-BH4 for Cardiovascular Indications
Phenylase for PKU
BIOMARIN:MATCHING PR OVEN SCIEN CE WIT H PROV EN N EE DS
On May 31, 2005, the U.S. Food and Drug Administration
(FDA) approved NaglazymeTM (galsulfase), the first enzyme
replacement therapy for the treatment of mucopolysacchari-
dosis VI (MPS VI). This was the second time in BioMarin’s
eight-year history that the company successfully advanced
a product through the clinic and into the marketplace.
At BioMarin, we are committed to developing and com-
mercializing innovative biopharmaceuticals for serious
diseases and medical conditions. We are aggressive in this
undertaking and seek product opportunities that suggest
a clear development path, provide an opportunity to be
first to market and, most importantly, will address unmet
medical needs.
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A MESSAGE FRO M THE CEO
2005 was a year marked by significant growth and success
for BioMarin: we increased net product sales of Aldurazyme®
(laronidase); we moved Naglazyme through clinical devel-
opment to market; we advanced and added to our product
pipeline; and we formed a strategic partnership that will
help fund our lead clinical programs. We enter 2006 with
continued resolve to build a sustainable biopharmaceutical
company that will satisfy the interests of our stockholders
and address unmet medical needs.
Net product sales of Aldurazyme for mucopolysaccharidosis
I (MPS I) by BioMarin/Genzyme LLC continued to grow
in 2005, increasing 79 percent in comparison to the previous
year. In line with this, our share of the profit from this 50/50
joint venture grew to $11.8 million for the year. As we
move forward in 2006, we expect to see increasing profits
from Aldurazyme as product sales continue to grow and as
we reduce research and development-related spending.
Net product sales of Naglazyme for MPS VI totaled $6.1
million in 2005. Naglazyme was approved by the FDA on
May 31, 2005, and subsequently by the European Commis-
sion in late January 2006. We anticipate net product sales
of Naglazyme to increase significantly in 2006 as more
individuals begin receiving commercial treatment in the
United States, Europe and other parts of the world.
With regard to our product pipeline, in April 2005, we initiated
a Phase 3 clinical trial of PhenoptinTM (sapropterin dihydro-
chloride) for the treatment of phenylketonuria (PKU).
Phenoptin is a synthetic form of 6R-BH4 (commonly known
as tetrahydrobiopterin or BH4), an enzyme cofactor that
works in combination with the enzyme needed to metabolize
Leadership team from left to right:
Jean-Jacques Bienaimé
Chief Executive Officer
Emil Kakkis, M.D., Ph.D.
Chief Medical Officer
Jeffrey Cooper
Vice President
Chief Financial Officer
Robert Baffi, Ph.D.
Senior Vice President
Technical Operations
G. Eric Davis
Vice President
General Counsel &
Secretary
Stephen Aselage
Senior Vice President
Global Commercial Operations
Stuart Swiedler, M.D., Ph.D.
Senior Vice President
Clinical Affairs
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phenylalanine (Phe). We announced positive results from
this trial in March 2006 that demonstrated a highly statistically
significant reduction in blood Phe levels (p‹0.0001) following
six weeks of treatment with Phenoptin versus placebo. This
was the primary endpoint of the trial. Phenoptin was well
tolerated and the type and incidence of adverse events was
similar in the Phenoptin and placebo groups. We remain
on-track to file a New Drug Application (NDA) in early 2007.
Phenoptin has been designated an orphan drug in the
United States and Europe and assigned Fast Track status
in the United States. We are developing Phenoptin in
collaboration with Serono, our corporate partner as of May
2005, which will equally share Phase 3 development costs
in exchange for rights to market Phenoptin outside of the
United States and Japan.
In May 2005, we licensed expanded intellectual property
rights to 6R-BH4 for cardiovascular indications—an
investigational product candidate that could provide us with
an opportunity to break into markets with substantial
commercial potential. In addition to the possible application
of 6R-BH4 in treating PKU, researchers have established
that a deficiency of 6R-BH4 contributes to endothelial
dysfunction and, in academic studies, they have demon-
strated that administration of 6R-BH4 improves vascular
endothelial function in animal models and individuals
with diabetes and cardiovascular disease. In 2006, we plan
to initiate two Phase 2 clinical trials of 6R-BH4, beginning
with one in poorly controlled hypertension.
Our 6R-BH4 program provides
us with the opportunity to expand
beyond orphan drug markets
into new markets that may offer
substantial commercial potential.
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We are excited about what we have accomplished in 2005
and the opportunities that are ahead of us. The key to
our continued success lies in our ability to strike a balance
between improving our financial performance and
investing in new product opportunities. To this end, we
remain focused on accelerating the growth and profitability
of Naglazyme and Aldurazyme, leveraging our manufac-
turing and commercial infrastructure, and identifying
new opportunities that will help to further strengthen
our company.
I would like to extend my sincere appreciation to our board
of directors and our scientific advisory boards, especially
those formed to guide our PKU and cardiovascular programs,
for sharing with us their leadership and scientific expertise.
To our employees, I gratefully acknowledge their hard
work and dedication toward meeting our aggressive
corporate goals and making new therapies a reality.
Finally, I extend my appreciation to our stockholders
for placing their confidence in us at BioMarin and for
investing in our future.
The key to our continued success
lies in our ability to strike a balance
between improving our financial
performance and investing in new
product opportunities.
Sincerely,
Jean-Jacques Bienaimé
Chief Executive Officer
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AL DURAZYME NET PRODU CT S AL ES
NAGLAZYME NET PRODUCT SALES
2005 S TOCK C HAR T
As recorded by BioMarin/Genzyme LLC.
All profits/losses are shared equally between
BioMarin and Genzyme Corporation.
Aldurazyme was approved in the United States
and Europe in April and June 2003, respectively.
Naglazyme was approved in the United States and
Europe in May 2005 and January 2006, respectively.
2005 sales: $6.1 million
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through BioMarin/Genzyme LLC increased substantially
in comparison to the previous year. This continued growth
led the joint venture to profitability in 2005—a first since
the partnership was formed. We expect net product sales
of Aldurazyme to continue to increase in 2006.
Within three weeks of approval, we launched Naglazyme in
the United States and, before it was approved in Europe,
we were selling it on a named–patient basis. Each quarter
we transitioned more individuals onto commercial therapy,
resulting in $6.1 million of net product sales for 2005.
Commercializing Naglazyme on our own in both the United
States and Europe positions us to realize a profit from the
product more quickly than had we outsourced it to a third party.
We expect net product sales of Naglazyme to continue to
grow in 2006 as it is approved in additional countries and
more individuals begin treatment.
The partnership we formed with Serono in May 2005 helped
us to advance Phenoptin into Phase 3 development and
contributed to our decrease in net loss in 2005 in comparison
to the previous year. In 2005, pursuant to our agreement,
we received a $25 million upfront payment and equally
shared Phase 3 development costs associated with
Phenoptin. Looking ahead, we expect this partnership to
continue to help us advance our PKU and cardiovascular
programs and support our effort to reduce our net cash use.
In 2005, our stock price increased over
68 percent—a reflection of the progress
we made throughout the year.
5
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PRO DUCTS ON THE MARKET
AL DURA ZYME
FOR MPS I
NAGLAZYME
FOR MP S V I
Aldurazyme is now available in over 30 countries worldwide
and remains the only drug therapy for the treatment of
MPS I. MPS I is a progressive, life-threatening genetic dis-
ease characterized by a deficiency of alpha-L-iduronidase,
a lysosomal enzyme. Aldurazyme is an enzyme replacement
therapy that provides MPS I patients with a recombinant
version of this enzyme. Today over 400 individuals are
receiving treatment with Aldurazyme, and we expect this
number to increase as more patients are identified and
approvals are attained in additional countries.
We developed Aldurazyme in partnership with Genzyme
and received FDA approval in just over five and a half years
after filing the Investigational New Drug Application (IND).
Aldurazyme is manufactured by BioMarin and commercialized
by Genzyme.
Naglazyme is the first enzyme replacement therapy for the
treatment of MPS VI. Similar to MPS I, MPS VI is a progres-
sive, life-threatening genetic disease characterized by a
deficiency of a lysosomal enzyme. Naglazyme provides
patients with a recombinant version of this enzyme,
arylsulfatase B. We believe that early diagnosis is crucial
to preventing irreversible multisystemic damage caused
by MPS VI. To this end, we are working to educate pediatri-
cians about the signs and symptoms of the disease so
that individuals can be promptly referred to genetic specialists
for diagnosis and treatment.
We independently developed Naglazyme and received
FDA approval in just over five years after filing the
IND. Naglazyme is manufactured and commercialized
by BioMarin.
Regulatory authorities in the United
States and Europe have granted
Aldurazyme for MPS I and Naglazyme
for MPS VI orphan drug status, confer-
ring seven years of market exclusivity
in the United States and 10 years in
the European Union.
6
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PRO DUCTS IN DEV ELOPMEN T
PHENOPTI N FOR PKU
6R- BH4
FOR CARD IOVAS CU LAR IND ICATI ON S
Phenoptin is an investigational small–molecule oral thera-
peutic for the treatment of PKU. The active ingredient in
Phenoptin is a synthetic form of 6R-BH4, an enzyme cofac-
tor that plays a key role in metabolizing phenylalanine
(Phe). Phe is found in most protein-containing foods and if
not sufficiently metabolized, it accumulates in the blood.
Sustained elevated blood Phe levels can lead to serious
neurological complications, including mental illness, loss
of IQ and cognitive problems. We are developing Phenoptin
with the aim of providing BH4-responsive phenylketonurics
with a simple and effective way to manage their disease.
Currently, the only way to manage PKU is through a restricted
diet that is difficult for most to adhere to. We plan to file
an NDA in early 2007.
6R-BH4 is an investigational small–molecule oral therapeutic
for the treatment of cardiovascular indications. In addi-
tion to playing a role in metabolizing Phe, BH4 is required
for the production of nitric oxide in the endothelium.
Researchers have established that a deficiency of BH4
contributes to endothelial dysfunction and, in academic
studies, have demonstrated that administration of 6R-BH4
improves vascular endothelial function in animal models
and individuals with diabetes and cardiovascular disease.
In 2006, we plan to initiate a Phase 2 clinical trial of 6R-BH4
in poorly controlled hypertension followed by a Phase 2
clinical trial in a second indication with endothelial dys-
function. Additionally, we expect two investigator-sponsored
studies to be initiated in 2006, one in pulmonary arterial
hypertension and the other in coronary artery disease.
6R-BH4, commonly known as tetra-
hydrobiopterin (BH4), is a naturally
occurring enzyme cofactor. BioMarin
is evaluating its application in
treating PKU as well as endothelial
dysfunction seen in diabetes and
cardiovascular indications.
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7
This Annual Report contains ‘forward-looking statements’
as defined under securities laws. These statements can
generally be identified by the use of terminology such as
‘believes’, ‘expects’, ‘anticipates’, ‘plans’, ‘intends’, ‘may’,
‘will’, ‘projects’, ‘continues’, ‘estimates’, ‘potential’, ‘opportunity’,
and so on. Our actual results or experience could differ
significantly from the forward-looking statement. Factors
that could cause or contribute to these differences include
the results of our current clinical trials, our ability to
obtain regulatory approval for our product candidates, our
ability to successfully market our products and the
other factors discussed in the enclosed Form 10-K and the
section entitled ‘Risk Factors’ therein.
You should not place undue influence on these forward-
looking statements which speak only as of the date that
they were made. These cautionary statements should be
considered in connection with any written or oral forward-
looking statements that we may issue in the future. We
do not undertake any obligation to release publicly
any revisions to these forward-looking statements after
completion of the distribution of this Annual Report to
reflect later events or circumstances or to reflect the
occurrence of unanticipated events.
Aldurazyme is a registered trademark of BioMarin/Genzyme LLC.
We strengthened our management team
in 2005, adding key individuals to support
the continued growth of our commercial
and manufacturing operations.
EXECUTIVES
Jean-Jacques Bienaimé
Chief Executive Officer
Emil Kakkis, M.D., Ph.D.
Chief Medical Officer
Jeffrey Cooper
Vice President
Chief Financial Officer
Stephen Aselage
Senior Vice President
Global Commercial Operations
Jeff Ajer
Vice President
Sales & Marketing Operations
William Aliski
Vice President & General Manager
European Operations
Robert Baffi, Ph.D.
Senior Vice President
Technical Operations
G. Eric Davis
Vice President
General Counsel & Secretary
Steven Jungles
Vice President
Supply Chain
Daniel Maher
Vice President
Product Development
Victoria Sluzky, Ph.D.
Vice President
Quality & Analytical Chemistry
Stuart Swiedler, M.D., Ph.D.
Senior Vice President
Clinical Affairs
Amy Waterhouse
Vice President
Regulatory & Government Affairs
8
Jean-Jacques Bienaimé
Chief Executive Officer
Emil Kakkis, M.D., Ph.D.
Chief Medical Officer
Jeffrey Cooper
Vice President
Chief Financial Officer
Stephen Aselage
Senior Vice President
Global Commercial Operations
Jeff Ajer
Vice President
Sales & Marketing Operations
William Aliski
Vice President & General Manager
European Operations
Robert Baffi, Ph.D.
Senior Vice President
Technical Operations
G. Eric Davis
Vice President
Steven Jungles
Vice President
Supply Chain
General Counsel & Secretary
Daniel Maher
Vice President
Product Development
Victoria Sluzky, Ph.D.
Vice President
Quality & Analytical Chemistry
Stuart Swiedler, M.D., Ph.D.
Senior Vice President
Clinical Affairs
Amy Waterhouse
Vice President
Regulatory & Government Affairs
BOA RD OF DIRE CTORS
Jean-Jacques Bienaimé
Chief Executive Officer
BioMarin Pharmaceutical Inc.
Joseph Klein, III
Managing Director
Gauss Capital Advisors, LLC
Franz Cristiani
Retired Partner
Arthur Andersen LLP
Pierre Lapalme
Former President & Chief Executive Officer
North America Ethypharm, Inc.
Michael Grey
President & Chief Executive Officer
SGX Pharmaceuticals, Inc.
Alan Lewis, Ph.D.
President & Chief Executive Officer
Novocell, Inc.
Elaine Heron, Ph.D.
Chairman & Chief Executive Officer
Labcyte Inc.
Stock Listing
Corporate Headquarters
BioMarin Pharmaceutical Inc. is listed on
the
Nasdaq National Market and the SWX Swiss
Exchange under the symbol BMRN.
Transfer Agent
Mellon Investor Services
85 Challenger Road
Ridgefield Park, NJ 07660
T: 800.356.2017 (Domestic)
201.329.8660 (International)
BioMarin Pharmaceutical Inc.
105 Digital Drive
Novato, CA 94949
Tel: 415.506.6700
Fax: 415.382.7889
E-mail: ir@bmrn.com
www.BMRN.com
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