He vergesst Biomarin nicht (Annual Report) - 500 Beiträge pro Seite

[AST Industries]

Da redet alles über Biotech und über diesen Titel hört man kein
Wort mehr obwohl er gestern an der Nasdaq über 30% gemacht hat
Schaut ihn Euch mal an!!!

Greets
AST


BIOMARIN PHARMACEUTICAL INC (BMRN)

Annual Report (SEC form 10-K)

Management`s Discussion and Analysis of Financial Condition and Results of Operations

FORWARD-LOOKING STATEMENTS

The following discussion and analysis of financial condition and results of operations contains "forward-looking statements" as
defined under securities laws. These statements can often be identified by the use of terminology such as "believes," "expects,"
"anticipates," "plans," "may," "will," "projects," "continues," "estimates," "potential," "opportunity" and so on. These
forward-looking statements may be found in the "Risk Factors," and other sections of this document. Our actual results or
experience could differ significantly from the forward-looking statements. Factors that could cause or contribute to these
differences include those discussed in "Risk Factors," as well as those discussed elsewhere in this document.

Overview

We are a developer of carbohydrate enzyme therapies for debilitating, life-threatening, chronic genetic disorders and other
diseases or conditions. Since our inception on March 21, 1997, we have been engaged in research and development activities,
including preclinical studies, clinical trials and clinical manufacturing, the establishment of laboratory and manufacturing facilities,
and administrative activities. BioMarin was incorporated in October 1996 as a wholly-owned subsidiary of Glyko Biomedical
Ltd. or GBL (TSE: GBL). BioMarin was initially funded by GBL and began operations on March 21, 1997, the date of
inception.

We have incurred net losses since inception and had an accumulated deficit through December 31, 1999 of $43.1 million. Our
losses have resulted primarily from research and development activities and related administrative expenses. Based on current
plans, we expect to continue to incur operating losses at least through 2002.

To date, we have not generated revenues from the sale of our drug candidates. Our lead product is AldurazymeTM, alronidase
for injection, (recombinant human (alpha)-L-iduronidase), which is under clinical trials for use in enzyme replacement therapy
for Mucopolysaccharidosis-I or MPS-I. In previous documents, AldurazymeTM was identified as BM101. Our financial
results may vary depending on many factors, including:

. The progress of AldurazymeTM in the regulatory processes and initial sales activities

. The investment in manufacturing process development and in manufacturing capacity for AldurazymeTM and other product
candidates

. The acceleration of our other pharmaceutical candidates into preclinical studies and clinical trials

. The progress of our additional research and development efforts

In September 1998, we established a joint venture with Genzyme for the worldwide development and commercialization of
AldurazymeTM for the treatment of MPS-I. Under the agreement, our company and Genzyme are each required to make
capital contributions to the joint venture equal to 50% of the expenses associated with the development and commercialization
of AldurazymeTM. We will share equally in any profits generated from the sales of AldurazymeTM.

In October 1998, we acquired Glyko, Inc., a wholly-owned subsidiary of GBL in a transaction valued at $14.5 million. Glyko,
Inc. provides products and services that perform carbohydrate analysis and medical diagnosis to research institutions and
commercial laboratories.

In July 1999, we completed our initial public offering or IPO of 4.5 million shares of our common stock at $13 per share raising
net proceeds of approximately $51.9 million. In a private placement concurrent with the IPO, Genzyme purchased $10 million
of our common stock (769,230 shares) at the IPO price of $13. In addition, the $26 million of convertible notes sold by the
Company on April 13, 1999, plus accrued interest, were converted into 2,672,020 shares of common stock at $10 per share.

In August 1999, the underwriters exercised their over-allotment option for 675,000 shares at the IPO price of $13 per share,
raising additional net proceeds of $8.1 million.

Results of Operations

Years Ended December 31, 1998 and 1999

For the years ended December 31, 1998 and 1999, revenues were $1.2 million and $7 million, respectively. Included in 1999
revenues is $5.3 million for services provided to the joint venture for Aldurazyme(TM) compared to $837,000 for 1998 as a
consequence of Aldurazyme(TM) being in more complex, later stages of development and the effect of a full year of operation
in 1999 compared to approximately three months of operation in 1998. The joint venture with Genzyme General (Nasdaq:
GENZ) for the development and commercialization of

Aldurazyme(TM), alronidase for injection, (recombinant human
(alpha)-L-iduronidase) for the treatment of Mucopolysaccharidosis-I (MPS-I) was
formed on September 4, 1998. MPS-I is a chronic, debilitating genetic disease
which afflicts children and leads to death before adulthood in a majority of
patients. Revenues also included $1.5 million generated by Glyko, Inc. compared
to $250,000 for 1998. Glyko, Inc., a BioMarin subsidiary engaged in the sale of
analytical and diagnostic products and services, was acquired by BioMarin on
October 7, 1998. External revenues for products and services for 1999 were up in
comparison to 1998 as a result of revenues from the biochemical reagents
business of Oxford GlycoSciences Plc. (LSE: OGS), which was acquired in May
1999.

Cost of products and cost of services related to Glyko, Inc. operations were $464,000 for 1999 compared to $108,000 for
1998. Glyko`s external products and services costs as a percent of the sales of products and services were 32% for 1999 and
44% for 1998. The improvement was due to a favorable revenue mix, with a greater percentage of higher margin product sales.

Research and development expenses increased from $10.5 million for 1998 to $27.2 million for 1999. Increased expenses in
support of the Aldurazyme(TM) joint venture with Genzyme and the MPS-VI and burn debridement programs were the major
factors in the growth of research and development expenses.

Selling, general and administrative expenses increased from $3.5 million for 1998 to $6.8 million for 1999. This increase
resulted from the consolidation of Glyko, Inc. selling and administrative expenses in 1999 expenses, an increase in staffing in
BioMarin administration in 1999 compared to 1998, and a related increase in facilities expense charged to administration in
1999. The increase in administrative staff and related expense was necessary to support expanded operations.

BioMarin`s equity in the loss of its joint venture with Genzyme increased from $47,000 for 1998 to $1.7 million for 1999
primarily as a result of increased process development and clinical manufacturing expenses. The joint venture began in
September 1998 and operated for only approximately one quarter of that year as compared to a full year of operation in 1999.

Interest income increased by $1.1 million from $685,000 for 1998 to $1.8 million for 1999 primarily due to increased cash
reserves resulting from a convertible note financing in April 1999, the initial public offering in July and August 1999, and the
private placement with Genzyme in July 1999.

Interest expense related primarily to interest on the convertible notes accrued prior to their conversion in the initial public
offering.

The net loss was $12.3 million ($0.55 per share) and $28 million ($0.94 per share) for 1998 and 1999, respectively.

The Period From March 21, 1997 (Inception) to December 31, 1997 and the Year Ended December 31, 1998

In October 1998, we acquired Glyko, Inc. from GBL. The acquisition was accounted for as a purchase. As a result, our
consolidated statements of operations data include the operations of Glyko, Inc. from October 7, 1998, the date of the
acquisition, through December 31, 1998.

BioMarin generated revenues of $1.2 million in 1998 consisting primarily of $837,000 of revenue from the BioMarin/Genzyme
LLC joint venture representing services performed by BioMarin for the joint venture, $250,000 from the sale of Glyko, Inc.
products and services since its acquisition on October 8, 1998, and $103,000 of other revenues representing grants received
from the federal government to fund various research projects. Glyko, Inc. sold products and services to BioMarin at a 27%
distributor discount. There were no revenues in the 1997 period.

In 1998, BioMarin had cost of goods sold of $108,000 as a result of the sale of Glyko, Inc products. In the 1997 period,
BioMarin had no sales and, consequently, no cost of goods.

Research and development expenses were $10.5 million in 1998, compared to $1.9 million in the 1997 period. The increase
was due primarily to a full year of Aldurazyme(TM) expenses including 12 months of clinical trials in 1998, compared with only
one month of clinical trials in the 1997 period. In addition, we expanded significantly our product programs, staff and facilities in
1998 in contrast to limited start-up research and development activities in the 1997 period.

General and administrative expenses were $3.5 million in 1998 compared to $914,000 in the 1997 period. General and
administrative expenses increased in 1998 to support the significantly expanded scale of operations in 1998 compared to the
smaller administrative requirements in the shorter, start-up 1997 period. These increased administrative expenses included
significant increases in salaries and benefits for administrative staff, an increase in facilities costs and an increase in professional
service fees.

Interest income in 1998 was $685,000 while interest income totaled $65,000 in the 1997 period. The higher interest income in
1998 resulted from higher cash balances available for investment in 1998 as a result of the first private placement late in 1997, a
second private placement in mid-year 1998 and the Genzyme investment in the third quarter of 1998.

The net loss was $2.8 million ($0.34 per share) and $12.3 million ($0.55 per share) for 1997 and 1998, respectively.

Liquidity and Capital Resources

We have financed our operations since our inception by the issuance of common stock and convertible notes and the related
interest income earned on cash balances available for short-term investment. We were initially funded by GBL with a $1.5
million investment. We have since raised additional capital from the sale of common stock in private placements, the sale of
promissory notes convertible into common stock, an investment of $8.0 million by Genzyme as part of our joint venture with
them, an initial public offering including the underwriters` over-allotment exercise and the concurrent $10 million Genzyme
investment in our Company. Since inception, we have raised aggregate net proceeds of $124.9 million.

Our combined cash, cash equivalents and short-term investments totaled $63.0 million on December 31, 1999, an increase of
$51.6 million from December 31, 1998. The primary source of increased cash balances was the issuance of common stock at
our IPO, generating $60.0 million of net proceeds including the underwriters over-allotment. The primary use of cash during the
year ended December 31, 1999 was to finance operations and to purchase leasehold improvements and equipment.
Operations used $13.1 million, we purchased $22.9 million of leasehold improvements and equipment, invested $6.7 million in
the joint venture (which was consumed in joint venture operations) and purchased $1.5 million of assets from Oxford
GlycoSciences.

From our inception through December 31, 1999, we have purchased approximately $29.5 million of leasehold improvements
and equipment. We expect that our investment in leasehold improvements and equipment will increase significantly during the
next two years because we will provide facilities and equipment for a larger staff and increase manufacturing capacity.

We have made and plan to make substantial commitments to capital projects, including AldurazymeTM and other enzyme
manufacturing capacity and new research and development facilities in Novato.

On October 7, 1998, we purchased Glyko, Inc. from GBL for an aggregate purchase price of $14.5 million. The purchase
price was paid by 2,259,039 shares of our common stock, our assumption of certain stock options held by Glyko, Inc.
employees, which were exercisable into a maximum of 255,540 shares of our common stock and $500 in cash.

As part of the acquisition of Glyko, Inc., we acquired in-process research and development projects, the value of which was
expensed as a portion of the purchase price at the time of the acquisition. The 11 projects acquired are each relatively small
and can be grouped into two categories, analytic projects and diagnostic projects.

The analytic projects are intended to expand the analytic product line by adding new enzymes for reagent sales, new kits for
agricultural applications, new instrument capabilities for protein analysis and a major upgrade of software capabilities. At the
time of the acquisition of Glyko, Inc., all of the analytic projects had completed feasibility work and the software projects were
75% complete and have since been completed. The development of specialized materials supporting instrument capabilities is
deemed to be the most difficult technical hurdle for the completion and commercialization of the analytic projects. The fair value
of the analytic projects was $1.7 million at the time of the acquisition.

The diagnostic projects are intended to expand a product line based on very precise measurements of the level of complex
carbohydrates in blood and urine as indicators of serious disease conditions including heart disease, kidney disease and
mucopolysaccharidoses or carbohydrate storage diseases. At the time of the Glyko, Inc. acquisition, preliminary feasibility
work had been done for all of the projects and a software project was well advanced as to programming, which has since been
completed. The development of new more sensitive carbohydrate chemistry techniques is deemed to be the most difficult
technical hurdle for the completion and commercialization of the diagnostic products. The fair value of the diagnostic projects
was $924,000 at the time of the acquisition.

As of December 31, 1999, we had expended to date approximately $720,000 on the in-process research and development
projects and $775,000 on the diagnostic projects. If all acquired in-process research and development projects proceed to
completion, we expect to spend approximately $390,000 in incremental direct expense to complete the analytic projects in
phases over approximately 15 months. We expect to spend approximately $950,000 to complete the diagnostic projects in
phases completed from 3 to 15 months in the future. None of these projects have been terminated to date.

Since the acquisition of these in-process research and development projects fifteen months ago, there have been no subsequent
developments which indicate that the completion and commercialization of either of the projects are less likely to be completed
on the original planned schedule or less likely to be a commercial success.

In September 1998, we established a joint venture with Genzyme for the worldwide development and commercialization of
AldurazymeTM for the treatment of MPS-I. We will share expenses and profits from the joint venture equally with Genzyme.
Genzyme purchased $8.0 million in common stock upon signing the agreement and $10.0 million of common stock at the IPO
price of $13 per share in a private placement concurrent with the IPO. Genzyme has committed to pay us an additional $12.1
million upon approval of the biologics license application for AldurazymeTM.

In July 1999, we completed our initial public offering of 4.5 million shares of our common stock at $13 per share raising net
proceeds of $51.2 million. In a private placement concurrent with the IPO, Genzyme purchased $10 million of our common
stock (769,230 shares) at the IPO price of $13.

In August 1999, the underwriters exercised their over-allotment option for 675,000 shares at the IPO price of $13 raising
additional net proceeds of $8.1 million.

We believe that the cash, cash equivalents, short-term investment securities balances at December 31, 1999 will be sufficient to
meet our operating and capital requirements through at least mid-year 2001. Until we can generate sufficient levels of cash from
our operations, we expect to continue to finance future cash needs through:

. The sale of equity securities

. Equipment-based financing

. Collaborative agreements with corporate partners

We do not expect to generate positive internal cash flow at least through 2002 because we expect to increase operational
expenses and manufacturing investment for the joint venture and to increase research and development activities, including:

. Preclinical studies, clinical trials and regulatory review

. Commercialization of our drug candidates

. Development of manufacturing operations

. Process development

. Scale-up of manufacturing facilities

. Sales and marketing activities

We anticipate a need for additional financing to fund the future operations of our business, including the commercialization of
our drug candidates currently under development. We cannot assure you that additional financing will be obtained or, if
obtained, will be available on reasonable terms.

Our future capital requirements will depend on many factors, including, but not limited to:

. The progress of our research and development programs

. The progress of preclinical studies and clinical trials

. The time and cost involved in obtaining regulatory approvals

. Scaling up, installing and validating manufacturing capacity

. Competing technological and market developments

. Changes and developments in collaborative, licensing and other relationships

. The development of commercialization activities and arrangements

. The leasing and build-out of additional facilities

. The purchase of additional capital equipment

We plan to continue our policy of investing available funds in government securities and investment grade, interest-bearing
securities, primarily with maturities of one year or less. We do not invest in derivative financial instruments, as defined by
Statement of Financial Accounting Standards No. 119.

Item 8. Financial Statements and Supplementary Data

The information required to be filed in this item appears on pages 44 to 66 and is incorporated herein by reference.

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

Not applicable.

[jupiter64]

Wer kann mir dies in ein paar Worten auf deutsch erklären ?
Grüsse und Dank
jupiter64

[jupiter64]

Was is den nun dran, an dem oberwähnten annual report. Sind es bloss
Jahreszahlen, oder wird ein neues Produkt zugelassen ??

[AST Industries]

Auszug aus dem SWX-Register

BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc. was founded in 1996 and commenced operational activities in March of 1997
in Novato, California.

BioMarin Pharmaceutical Inc. specializes in the discovery, development and commercialization of
carbohydrate enzyme therapeutics. Since inception in 1997, BioMarin has applied its proprietary enzyme
technology to the development of products in five therapeutic areas: genetic diseases, burn debridement,
fungal infections, male pro-fertility, and inflammation (psoriasis).

Glyko, Inc., a BioMarin subsidiary, provides analytical and diagnostic services in the area of carbohydrate
biology.



weiteres siehe Tread:
Biotech erst neu entdeckt! ... die BioMarin ist noch nicht gelaufen!

Greets
AST