FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934
For the month of October 2004
Commission File Number 000-28966
Biacore International AB (publ)
C/o Biacore International SA
Puits-Godet 12
CH-2000 Neuchatel
Switzerland
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.
Form 20-F X
Form 40-F
Indicate by check mark whether by furnishing the information contained in this
Form, the registrant is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act
of 1934.
Yes
No X
If "Yes" is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g3-2(b): Not applicable.
BIACORE ANNOUNCES UPDATE ON STRATEGIC BUSINESS REVIEW -
STREAMLINED ORGANIZATION SET TO CAPTURE GROWTH OPPORTUNITIES IN PROTEIN
INTERACTION ANALYSIS
Uppsala, Sweden, October 4, 2004.
Biacore International AB (Biacore) today announces an update on the Strategic
Business Review that was started following the Company's 2nd Quarter results,
which were released in July.
The proposed actions in the Strategic Business Review have been presented to the
Board of Directors. In accordance with Swedish labour laws (1), final decisions
will be made after negotiations with the trade unions. The Board of Directors
has therefore instructed Erik Wallden, President and CEO, to carry out such
negotiations.
The key conclusions from the Strategic Business Review are as follows:
* The review has identified a number of growth opportunities for Biacore's
business based on the ability to provide unique real-time data on protein
interactions, a key area of life science research. The most commercially
interesting applications for Biacore's instruments include antibody
characterization, interaction proteomics, lead optimization, and
bio-therapeutic development and production.
* The review has concluded that Biacore's sales processes and culture need to
undergo significant change to ensure that the Company is optimally positioned
to capture these growth opportunities. A number of steps have already been
taken to achieve this, the most important being the recent appointment of Mr
Jerry Williamson as President of Biacore, Inc. Future planned actions include
a realignment of our sales and applications teams and the recruitment of
additional experienced sales personnel.
* Biacore's investment in R&D is crucial to its future success. However, present
levels of spending are too high. As a result, it is proposed to reduce the
company's R&D personnel from 95 to 65. It is estimated that if implemented
this, and a reduction in the use of external consultants, will lead to annual
savings of SEK 55 million in Biacore's cash spending on R&D. A re-assessment
of the Company's array technology has also taken place. In order to secure the
optimal positioning and long-term market penetration for this novel
technology, a staged launch strategy has now been adopted. This, and a
reduction in the product's medium-term sales projections has resulted in a
SEK 44 million write-down in the value of this asset. This write-down will be
taken in 3rd Quarter 2004.
* The Business Review has highlighted the need for Biacore to improve its
operating efficiency and has included proposals to reduce the Company's
overall administration expenditure. To assist in achieving this goal, the
Strategic Business Review proposes that the Company's headquarters facility in
Neuchatel, Switzerland, is closed and functions re-located to Uppsala, Sweden,
by the middle of 2005. The proposal to close the Neuchatel facility was
approved by the Board of Directors.
* In total, when all of the actions proposed in the Strategic Business Review
have been decided and implemented, they will result in Biacore's headcount
globally being reduced by approximately 80 people from its current workforce
of 345. This will lead to one-off costs of approximately SEK 80 million
including the array technology write-down. Excluding this write-down, the
one-off costs will be charged to the Income Statement in 4th Quarter 2004.
These actions are expected to lead to potential net annualised savings of
approximately SEK 90 million. These savings will start in the final quarter of
2004, however most of them are expected to be realized gradually during the
course of 2005.
Erik Wallden, President and CEO of Biacore, commenting on today's announcement
said, "The aggressive cost cutting plans that we have outlined are necessary to
return Biacore to profitability in 2005 and to enable us to capture the growth
opportunities that clearly exist for our current range of instruments. I am
confident that we can utilize the re-focused strengths of the Biacore
organization to deliver the earnings growth that our shareholders expect, based
on the opportunities which exist for protein interactions analyses in life
science research and pharmaceutical and biotherapeutic development."
Background
In July 2004, in conjunction with the release of its 2nd Quarter results,
Biacore announced that the Board had asked the senior management team under the
direction of the Company's new President and CEO, Mr Erik Wallden, to undertake
a strategic review of its business. The Board tasked the management team to look
at a number of areas of Biacore's business including:
* The Company's top-line growth and its profitability, both of which were
considered unacceptable.
* The Company's R&D, where it was felt that the level of spending was too high
relative to current sales, and
* The Company's administrative costs, in an effort to ensure that all of
Biacore's resources were used as efficiently as possible.
Biacore's Growth Opportunities
A key element of the Strategic Business Review was to confirm the Board's view
that Biacore was operating in markets, which provided the Company with the
potential to deliver an attractive level of top-line growth.
The top-down and the bottom-up market analyses undertaken by the senior
management team have confirmed that Biacore does indeed have significant
potential for growth. These analyses show:
* That the global annual market for Biacore's SPR technology is in excess of
USD 500 million, leaving the Company considerable scope for growth.
* Biacore's instruments have applications in a number of the most attractive
areas of the life science research market such as antibody characterization,
interaction proteomics, lead optimization and bio-therapeutic development and
production, many of which are projected by external industry analysts,
including Frost & Sullivan, to have growth rates in excess of 10% per annum
for a number of years.
Based on these analyses, Biacore's management is confident of the growth
potential of the current business and intends to focus its future marketing
efforts on protein interaction applications where it believes the Company's
technology is able to deliver significant benefits to a broad range of customers
based on the key applications outlined above.
Optimizing Biacore's Sales Capabilities
The Strategic Business Review has highlighted a number of key issues with
Biacore's sales organization that will be addressed over the next several
months. These include:
* A commercially driven sales management team has been identified as crucial to
Biacore's return to profitable growth. Mr Jerry Williamson who has recently
joined the Company as the new President of Biacore, Inc. will be a key member
of this team.
* A realignment of the overall sales force structure. These proposed changes
will lead to a shift in the ratio of sales to applications personnel, as well
as a reduction in the administrative sales support. Once implemented, these
changes will provide the Company with more direct sales calls, at lower cost,
leading to significant efficiencies.
* The planned recruitment of additional sales representatives with experience in
selling to pharmaceutical and biotechnology companies. These new recruits will
improve the Company's ability to sell its instruments to customers where the
ability to manage a multi-level sales process is required.
* Finally, in order to drive a major change in the overall Biacore culture, the
Company's plans to include all employees in a sales training program during
the course of 2005.
Biacore expects that these changes will have a positive impact on the Company's
sales growth. In Europe, where the Company's new sales management team has
already implemented a number of these changes, revenues are now growing at an
attractive rate.
Streamlining Biacore's R&D
In the last several years, Biacore's R&D has delivered a number of new platform
products to the market. This has led to Biacore's investment in R&D rising
significantly in cash terms, largely as a result of the development of the
Company's new array technology. With this technology about to be commercialized,
Biacore's R&D spending was due to decline naturally. A significant part of this
decline in spending would have come from a reduction in the use of external
consultants. However, even with this anticipated decline, the Strategic Business
Review has identified that the level of R&D costs is too high in relation to
Biacore's revenues. As a result, the Company proposes to streamline its R&D
structure with the number of people being employed in R&D being reduced from 95
to 65. The Company plans to carefully carry out this proposed restructuring in a
way that Biacore retains all of the core skills that it needs to develop its
products in-house. If these proposals to streamline R&D are actioned, they will
result in a one-off cost of SEK 10 million to be taken in 4th Quarter 2004, and,
in conjunction with a reduction in the use of external consultants, are expected
to lead to annualised savings of SEK 55 million in cash R&D expenses.
In conjunction with these changes, Biacore also plans to refocus its R&D
activities to both expand its market reach and its overall competitiveness. The
areas that R&D will now focus on are:
* The initial commercialization of the new array technology, which is still on
track to take place in 4th Quarter 2004. The array technology will strengthen
the Company's offering to pharmaceutical and biotechnology companies, as well
as major academic centers focused on proteomics.
* The development of new software and other support tools that are designed to
make Biacore's current systems easier to use for all its key customer groups.
This improved "ease of use" will reduce the amount of applications support
needed for the sale of each system.
* New applications packages focused on the areas outlined earlier. These new
packages are crucial to ensuring Biacore maintains its competitive position in
these high-growth areas of the protein interactions market.
The review of R&D also entailed an analysis of the commercial potential of the
Company's array technology. Biacore's re-assessment of the target applications
for this product has led it to adopt a new approach to its commercialization.
Over the next twelve months, the roll-out of this exciting new technology will
be handled by a special commercialization team centered on Biacore's R&D
organisation and supported by Business Development personnel. This team
structure is designed to ensure that both the technical and economic benefits of
this novel approach to protein interaction analysis are clearly communicated,
initially, to a small number of academic research centers and pharmaceutical
companies. These first "high level" customers will help the Company to develop a
broad range of application protocols for this new system before it is launched
to a wider customer base through Biacore's entire sales team. Biacore is
confident that by adopting this approach it will achieve better long-term market
penetration for the array technology than would have occurred with the
previously planned launch strategy.
In addition, the Business Review has led to a re-assessment of the medium-term
sales potential for the array system. This is due to changed consensus growth
estimates for a number of important life science research markets, including
certain elements of the proteomics market, and the recognition that some of the
applications that Biacore had envisaged for the array technology will take
longer than previously thought to realize. Taken together, these changes have
led the Company to reduce the value of the capitalized R&D that is currently
held as an asset on the Company's balance sheet. This will lead to a write-down
of SEK 44 million that will be taken in the Company's 3rd Quarter results.
Managing Our Administration Costs
The final area covered by the Business Review was the Company's overall spending
on administration.
As a result, it has been proposed that to achieve the efficiencies in Biacore's
administrative structure it closes the Company's Headquarters in Neuchatel in
Switzerland. The Neuchatel Headquarters were established in 2002 when Biacore
was forecast to continue to grow rapidly. Based on these projections of growth,
the facility was expected to yield significant financial benefits for the
Company's shareholders.
The recent much slower than anticipated development of Biacore's sales has led
to the decision to close this facility. It is believed that this decision is
supported by the important operational benefits and administrative cost savings
that can be achieved. The closure of the Neuchatel facility is expected to take
place in mid 2005.
The one-off costs of streamlining the Company's central administration will be
approximately SEK 15 million.
The Financial Impact of Today's Update
In combination, all of the proposed actions arising from the Strategic Business
Review are designed to move the Company back to profitability as quickly as
possible while at the same time positioning it to deliver an attractive revenue
growth.
The proposed actions, when implemented, are expected to lead to a total
reduction in the Company's workforce by approximately 80 people from its current
level of 345, with all areas of Biacore's business being impacted. This
streamlining is designed to ensure that all of the key functions of Biacore's
business are operating as efficiently as possible.
In aggregate, the proposed actions should lead to one-off costs of approximately
SEK 80 million, including the SEK 44 million write-down of the array technology.
Excluding this write-down, the one-off costs will be charged to the Income
Statement in 4th Quarter 2004. These actions are expected to lead to net
annualised costs savings of approximately SEK 90 million. These savings will
start to be seen in 4th Quarter 2004, however most of them are expected to be
realized gradually during the course of 2005.
Conclusion
The proposals contained in the Strategic Business Review are designed to:
* Bring a more commercial focus to the whole Biacore organization,
* Develop a more capable and efficient global sales capability,
* Realign the Company's R&D spending with its current revenue base,
* Ensure the successful commercialization of the Company's new array technology
which over time Biacore still believes will be a major source of sales, and
* Reduce the Company's cost base to a level which will allow a return to overall
profitability as quickly as possible.
Commenting on today's announcement Mr Lars-Goran Andren, Biacore's Chairman
said, "I would like to thank Erik and his team for undertaking this far-reaching
review in such a short period of time. Although our planned actions are
obviously painful, they are necessary in order to restore Biacore to
profitability. Looking ahead, I am confident that the inherent strengths of the
Biacore organization, in conjunction with its enhanced commercial focus will
allow us to deliver the sales growth that our market analyses show we should
achieve."
About Biacore
Biacore is a global supplier of analytical systems that improve the productivity
of research and development in the life science and pharmaceutical markets. The
company's instruments generate unique data on protein interactions, an area of
increasing focus in these markets. The data give insights into protein
functionality, the role of proteins in normal and diseased states, and the
influence of potential drug candidates.
Use of Biacore's products is well documented in key areas such as antibody
characterization, proteomics, lead optimization and bio-therapeutic development
and production. Customers include world renown life science research centers,
all of the leading global pharmaceutical companies, and a large number of
companies in the emerging biotechnology sector.
Biacore is successfully expanding into the food analysis market, providing key
manufacturers with ready-to-use solutions for the determination of food quality
and safety.
The company offers a range of products to meet specific customer needs. All
instruments utilize Surface Plasmon Resonance (SPR) technology as the basis for
detection and monitoring of protein interactions.
Biacore has its own direct sales capability in the world's key markets, United
States, Europe, Japan, Australia and a distribution network in Asia-Pacific. The
company was created in 1984, is based in Uppsala, Sweden, and is listed on the
Stockholm Stock Exchange (SSE:BCOR).
Further information on Biacore can be found on the web: www.biacore.com.
(1) The Swedish Employment (Co-determination in the Workplace) Act stipulates,
in short, that before an employer decides on, among other things, an
important change in the business, negotiations shall be carried out with the
trade unions.
BIACORE SIGNS FIRST COMMERCIAL DEAL FOR ITS NEW SPR ARRAY TECHNOLOGY -
LEADING JAPANESE PROTEOMICS INSTITUTE BACKS EXCITING NEW TECHNOLOGY FOR LEADING
PROTEOMICS INITIATIVE
Uppsala, Sweden, October 20, 2004.
Biacore International AB (Biacore) announced today that it has signed its first
commercial deal for its new SPR (Surface Plasmon Resonance) array technology
with The Biological Information Research Center (BIRC) of The National Institute
of Advanced Industrial Science and Technology (AIST), a leading Japanese Life
Science Research Center specialized in proteomics. The deal with BIRC-AIST
signals the start of the first stage of the commercialization of Biacore's array
technology. The terms of the agreement with BIRC-AIST were not disclosed.
Biacore's new array technology aims to improve the speed with which detailed
protein interaction information can be generated by enabling the parallel
analysis of bio-molecules of interest against panels of proteins. This initial
commercial contract with BIRC-AIST is envisaged to be the first of a number of
deals with major pharmaceutical companies and world-leading life science
research institutes. This first set of commercial agreements is designed to
optimize further the range of applications that the technology can be used for,
particularly in the field of interaction proteomics. The initial
commercialization phase of the array technology will be managed by a specialist
product development team within Biacore that includes key R&D and business
development personnel.
"We are pleased to be working with Biacore KK, a reliable and respected company
in Japan. We feel that the incorporation of this new array platform into our
research initiatives will generate high-quality protein interaction information
that will make a valuable contribution to our program of screening cDNA
expression libraries," commented Dr Nomura, the Deputy Director of the
Biological Information Research Center, at AIST, Tokyo.
Erik Wallden, Biacore's President and CEO said: "today's announcement is a
significant step forwards in Biacore's objective to reinforce its product
offering. Biacore's ability to deliver its new SPR array technology on time
reflects the high level of skill and commitment of our R&D organization. The
controlled roll-out of this technology with a small number of key customers will
allow us to develop and optimize the technology's use in key target applications
in interaction proteomics and post-HTS small molecule characterization. We
expect that over time this new technology will become a major new tool across a
broad range of life science research applications."
About SPR Array Technology
Biacore's SPR array technology has been designed and developed for use in a
broad range of applications in proteomics, antibody characterization and many
areas within drug discovery including hit validation, compound library
screening, lead optimization and pre-clinical studies.
Biacore's array technology rapidly monitors protein interactions (thousands of
interactions per day) to generate high quality kinetic, affinity and selectivity
of binding information.
Biacore's new SPR array technology enables the parallel real-time analysis of
protein interactions combining increased throughput, with the sensitivity needed
to handle small molecule analysis. The array technology brings a new dimension
to the study of protein interactions by using parallel analysis to generate
crucial information on the behavior and interactions of a wide range of proteins
grouped into panels or other configurations. The system also includes new
software tools that have been optimized for array applications and are designed
to handle large data volumes.
About Biacore
Biacore is a global supplier of analytical systems that improve the productivity
of research and development in the life science, pharmaceutical and diagnostic
markets. The company's instruments generate unique data on protein interactions,
an area of increasing focus in these markets. These data give insights into
protein functionality, the role of proteins in normal and diseased states, and
the influence of potential drug candidates.
Use of Biacore's products is well documented in key areas such as antibody
characterization, proteomics, lead optimization and bio-therapeutic development
and production. Customers include leading life science research centers, all of
the leading global pharmaceutical companies, and a large number of companies in
the emerging biotechnology sector.
Biacore is successfully expanding into the food analysis market, providing key
manufacturers with ready-to-use solutions for the determination of food quality
and safety.
The company offers a range of products to meet specific customer needs. All
instruments utilize SPR technology as the basis for detection and monitoring of
protein interactions.
Biacore has its own direct sales capability in the world's key markets, United
States, Europe, Japan, Australia and a distribution network in Asia-Pacific.
The company was created in 1984 and is listed on the Stockholm Stock Exchange
(SSE:BCOR).
Further information on Biacore can be found on the web: www.biacore.com.
INTERIM REPORT JANUARY - SEPTEMBER 2004
* Biacore's sales in the third quarter 2004 amounted to SEK 134.6 million
(105.7), an increase of 27%, mainly as a result of strong sales in Europe. For
the first nine months of 2004, sales declined by 5% to SEK 337.2 million
(354.7).
* Operating income was hit by one-off costs of approximately SEK 58 million
related to the array technology write-down and to senior personnel departures
including Ulf Jonsson, Biacore's former President and CEO.
* The net loss in the third quarter amounted to SEK 25.1 million (-45.5). For
the nine-month period January-September 2004, the net loss was SEK 24.7
million (-11.1).
* The loss per share in the third quarter amounted to SEK 2.57 (-4.67). For the
first nine months 2004, the loss per share was SEK 2.53 (-1.14).
* Strategic roll-out of the array technology confirmed following conclusion of
the deal in October 2004 with AIST, a major Japanese research institute
focused on proteomics.
* The fourth quarter income is expected to be reduced by one-off costs of
approximately SEK 36 million related to actions from the Strategic Business
Review, announced on October 4. The one-off costs in the third and fourth
quarters are expected to lead to net savings in operating costs of
approximately SEK 90 million per annum.
* The outlook for the full-year 2004 is dominated by the one-off costs of
approximately SEK 94 million, associated with the significant changes that are
being made to the organization. As a result of these costs, Biacore expects to
record a loss in 2004. Sales are likely to be lower than in 2003. Previously,
Biacore had forecast that it did not expect sales and earnings per share for
the full-year 2004 to reach the levels achieved in 2003.
January - September July - September
2004 2003 Change 2004 2003 Change
Sales, SEK million 337.2 354.7 -5% 134.6 105.7 +27%
Operating loss, SEK million -19.4 -25.2 -19.8 -57.6
Operating margin, % -5.8 -7.1 -14.7 -54.5
Loss after financial items,
SEK million -16.6 -15.6 -19.2 -56.1
Net loss, SEK million -24.7 -11.1 -25.1 -45.5
Loss per share, SEK -2.53 -1.14 -2.57 -4.67
Erik Wallden, President and CEO of Biacore, commenting on today's results said
"I am encouraged by the sales development in this quarter and in particular what
we have achieved in Europe. The changes made to our European sales structure and
processes, over twelve months ago, are now clearly starting to deliver. Asia-
Pacific showed good growth in the third quarter with signs of recovery in Japan.
These positives, along with the commercial introduction of our new SPR array
technology, give me confidence that we can turn Biacore around next year."
Operational Review
Amounts stated in this report relate to the Biacore Group, unless otherwise
indicated. Figures in parentheses refer to the corresponding period in 2003.
Sales
Biacore's third quarter showed an encouraging sales trend with overall revenues
up 27% to SEK 134.6 million. The pattern of sales development varied
considerably across the key markets in which the Company operates. In Europe,
the changes that were made to the region's sales structures and processes,
starting over twelve months ago, are now clearly having a positive impact. In
the U.S., some of the weaknesses that have been identified as part of the
Strategic Business Review were again evident with sales declining for the second
quarter in a row. Revenues in the Asia-Pacific region increased in the quarter
due to a strong performance outside Japan. The reorganization and
de-centralization of academic research in Japan has continued to delay sales.
Excluding the impact of exchange rates, total Group sales for the first nine
months of 2004 increased by 3%.
Sales were divided geographically as follows:
January-September July-September
SEK million 2004 2003 Change 2004 2003 Change
Americas 133.7 159.2 -16% 45.7 52.8 -13%
Europe 134.3 93.3 44% 52.3 22.6 131%
Asia-Pacific 69.2 102.2 -32% 36.6 30.3 21%
The potential for Biacore's business to recover was clearly seen in Europe,
where sales increased by 131% to SEK 52.3 million in the third quarter 2004.
This strong performance was due to a positive funding environment in terms of
both academic and industrial customers and improvements that have been made in
the sales organization and processes. Each of these major customer groups
contributed equally to sales during the period. Good sales were seen in a number
of countries including Denmark, where a number of systems where sold to academic
customers.
In the U.S., the funding environment is still weaker than had been anticipated,
and as a result third quarter sales declined by 13% to SEK 45.7 million.
Declines were seen both from pharmaceutical and academic customers. However, the
biotech sector was stronger based on the slightly improved funding situation.
Sales in Asia-Pacific outside Japan were extremely strong with the food sector
making an important contribution. This led to an overall 21% sales increase in
this region. There are signs in Japan that the funding environment is
stabilizing, and Biacore is more confident of seeing an improving sales trend in
this key market over the next six months. However, the disruption that has been
seen this year as a result of changes to the funding of academic research
continued to adversely impact Biacore's sales in Japan in the third quarter. The
industrial market continues to be a relatively small part of Biacore's business
in Japan.
Turning to the sales of Biacore's key systems, some very positive developments
were seen. Biacore(r)3000 sales were up strongly during the period due to good
sales to academic customers, as well as increased sales to industrial customers
in Europe. Sales of this system in combination with the GxP package were seen to
European companies that are focused on meeting the regulatory requirements from
the FDA either in terms of product development or production. Sales of
Biacore(r)S51 were also higher in both the U.S. and Europe in the third quarter,
reflecting the improved sales approach to selling this system to key
pharmaceutical customers. More customer-generated data highlighting the benefits
of this product in the area of lead optimization have also been a positive
factor, and as more data becomes available it augurs well for the medium term
sales of this product. Sales of Biacore(r)Q to the food industry were also
strong during the third quarter.
Financial Performance
The gross margin during the first nine months of 2004 was 76% (80).
Total costs for marketing, administration and research and development increased
by 61% in the third quarter of 2004 to SEK 124.4 million (77.1). This
significant increase was due to the SPR array write-down announced at the time
of the Strategic Business Review and higher administration costs due to changes
in senior management.
R&D costs in the third quarter amounted to SEK 57.0 million (18.9). This much
higher level was due to the SEK 44.6 million array technology write-down of
costs previously capitalized. During the first nine months of 2004, Biacore's
R&D costs amounted to SEK 93.1 million (56.7). SEK 45.3 million (32.5) of
development expenses, largely related to the development of the new array
system, were capitalized in the same period.
In the third quarter of 2004, Biacore incurred an operating loss of SEK 19.8
million (-57.6), entirely due to one-off costs outlined earlier. These included
a SEK 44.6 million write-down of the balance sheet value of the capitalized R&D
relating to the new array technology and SEK 13 million in severance costs
relating to senior management changes. The loss recorded in the third quarter
2003 was due to the write-down associated with the Company moving out of the
cell-based assay market.
Operating currency differences during the third quarter amounted to SEK 0.2
million (-2.0). Financial items in the first nine months of 2004 include a
write-down of long-term investments of SEK 0.6 million. The first nine months of
2003 included SEK 4.0 million in income from long-term investments.
Biacore incurred a net loss in the third quarter of 2004 of SEK 25.1 million
(-45.5), giving a loss per share of SEK 2.57 (-4.67). For the first nine months
of 2004, the net loss, after taxes of SEK 8.0 million, caused by the
geographical distribution of earnings, amounted to SEK 24.7 million (-11.1). The
loss per share in the first nine months of 2004 was SEK 2.53 (-1.14).
Capital Expenditures
During the first nine months of 2004, Biacore's capital expenditures totaled
SEK 7.1 million (11.6).
Personnel
At the end of September 2004, Biacore had 347 (343) permanent employees.
Strategic Business Review
On October 4, 2004, Biacore announced the planned changes to the Company which
resulted from the senior management's Strategic Business Review. The key changes
put forward are focused on improving the Company's sales structure and processes
as well as a commercial refocusing of Biacore's R&D organization.
As part of these changes, Biacore has announced the promotion of two key
individuals who will play an important role in ensuring that the changes
resulting from the Strategic Business Review return Biacore to profitable growth
as quickly as possible. The two individuals concerned are:
* Paul James, who has become Senior Vice President of Commercial Operations. In
this new position, Paul will be responsible for all of Biacore's sales,
product management and marketing activities globally. This new structure is
designed to ensure that best sales practices are adopted across the whole
organization globally. In addition, Paul's new position is designed to
maximize the sales support that Biacore's marketing activities can provide
across all of the Company's key customers in academia, and in the
pharmaceutical, biotech and food industries. Paul was previously responsible
for Biacore's European sales operations. Before joining Biacore, Paul worked
for Packard Biosciences in the U.S. for four years in a variety of marketing
positions.
* Anders Falt, who has been appointed Senior Vice President of Technology
Operations. In this new position, Anders will be responsible for Biacore's
R&D, Product Supply, Project Management and Quality Assurance. The grouping of
all of these functions under Anders will allow Biacore to seamlessly manage
the aspects of its product development and supply to ensure that new products
are brought to market in a timely and cost effective manner. Prior to this
promotion, Anders was Vice President and Head of R&D and has worked for
Biacore for over ten years.
With these additions to the senior management team, Biacore is in a strong
position to deliver the key goals of the recent Strategic Business Review,
namely returning Biacore to profitability as quickly as possible and creating a
sales organization that will allow the Company to increase sales at an
attractive rate.
The New Array System
Biacore has started the strategic roll-out of its new array technology with the
Company's first commercial deal with The National Institute of Advanced
Industrial Science and Technology (AIST) in Japan.
This initial commercial contract with AIST is envisaged to be the first of a
number of deals with major pharmaceutical companies and world-leading life
science research institutes. This first set of commercial agreements is
designed to optimize further the range of applications that the technology can
be used for, particularly in the field of interaction proteomics. The initial
commercialization phase of the array technology will be managed by a specialist
product development team within Biacore that includes key R&D and business
development personnel.
Nominations Committee
Until the annual general meeting of shareholders in 2005, the nominations
committee consists of Lars-Goran Andren, chairman of the board; Inger Brattne,
Pfizer; Stefan Roos, Handelsbanken Fonder and Thomas Ehlin, Nordeas fonder.
ACCOUNTING PRINCIPLES
This interim report has been prepared in accordance with the Swedish Financial
Accounting Standards Council's Statement No. 20 (RR20) Interim Financial
Reporting. In 2004, the Council's Statement No. 29 (RR29) Employee Benefits,
which includes a new method for calculating provisions for pensions, became
effective. As of January 1, 2004, this standard reduced shareholders' equity by
SEK 4.8 million. Net income for the first nine months of 2004 was only
marginally affected by the new standard.
QUARTERLY SALES VARIATIONS
Biacore's total sales during the period 2001-2003 were split between quarters as
follows:
Quarter 1 23% Quarter 3 22%
Quarter 2 25% Quarter 4 30%
Outlook for the Full-Year 2004
The outlook for the full-year 2004 is dominated by the one-off costs of
approximately SEK 94 million, associated with the significant changes that are
being made to the organization. As a result of these costs, Biacore expects to
record a loss in 2004. Sales are likely to be lower than in 2003. Previously,
Biacore had forecast that it did not expect sales and earnings per share for the
full-year 2004 to reach the levels achieved in 2003.
Neuchatel, Switzerland, October 21, 2004
Biacore International AB (publ)
Erik Wallden
President and CEO
Review Report
We have carried out a review of this interim report in accordance with the
recommendation issued by FAR (the Institute for the Accountancy Profession in
Sweden). A review is significantly limited in comparison with an audit.
Nothing has come to our attention which would cause us to believe that the
interim report does not meet the requirements of the (Swedish) Securities
Exchange and Annual Accounts Acts.
Stockholm, October 21, 2004
PricewaterhouseCoopers AB
Sten Hakansson
Authorized Public Accountant
Financial Information
Biacore plans to release its year-end report for 2004 on February 17, 2005.
Biacore is a global supplier of analytical systems that improve the productivity
of research and development in the life science and pharmaceutical markets. The
company's instruments generate unique data on protein interactions, an area of
increasing focus in these markets. The data give insights into protein
functionality, the role of proteins in normal and diseased states, and the
influence of potential drug candidates.
Use of Biacore products is well-documented in key areas such as antibody
characterization, proteomics, lead optimization and bio-therapeutic development
and production. Customers include world renown life science research centers,
all of the leading global pharmaceutical companies and a large number of
companies in the emerging biotechnology sector.
Biacore is successfully expanding into the food analysis market, providing key
manufacturers with ready-to-use solutions for the determination of food quality
and safety.
The company offers a range of products to meet specific customer needs. All
instruments utilize Surface Plasmon Resonance (SPR) technology as the basis for
detection and monitoring of protein interactions.
Biacore has its own direct sales capability in the world's key markets, United
States, Europe, Japan, Australia and a distribution network in Asia-Pacific. The
company was created in 1984, is based in Uppsala, Sweden, and is listed on the
Stockholm Stock Exchange www.stockholmsborsen.se (SSE:BCOR).
This report contains certain forward-looking statements which, by their nature,
involve risk and uncertainty because they relate to events and depend on
circumstances that will occur in the future. There are a number of factors that
could cause actual results and developments to differ materially from those
expressed or implied by these forward-looking statements. Accordingly, investors
and shareholders are urged not to place undue reliance on these statements.
Biacore International AB (publ)
Company registration number: 556534-5211
Head office
Biacore International SA, Puits-Godet 12, CH-2000 Neuchatel, Switzerland
Phone +41 32 720 9000
info(at)biacore.com
www.biacore.com
Biacore Consolidated Income Statements
Full
January-September July-September year
SEK million 2004 2003 Change 2004 2003 Change 2003
Sales 337.2 354.7 -5% 134.6 105.7 27% 515.5
Cost of sales -81.9 -71.5 15% -29.0 -18.4 58% -94.0
Marketing -125.6 -120.2 4% -42.8 -38.5 11% -165.4
Administration -52.9 -53.9 -2% -24.6 -19.7 25% -71.1
Research and development -93.1 -56.7 64% -57.0 -18.9 202% -78.6
Other income and expenses -0.1 -9.9 - -2.1 -14.4
Amortization of goodwill -3.0 -3.0 -1.0 -1.0 -4.0
Items affecting comparability - -64.7 - -64.7 -58.5
Operating income (loss) -19.4 -25.2 -23% -19.8 -57.6 -66% 29.5
Financial items, net 2.8 9.6 0.6 1.5 11.9
Income (loss) after financial items -16.6 -15.6 6% -19.2 -56.1 -66% 41.4
Income taxes -8.0 4.4 -5.7 10.6 2.9
Minority interest -0.1 0.1 -0.2 - -
Net income (loss) -24.7 -11.1 -25.1 -45.5 44.3
Basic earnings (loss) per share,
SEK -2.53 -1.14 -2.57 -4.67 4.55
Diluted earnings (loss) per share,
SEK -2.53 -1.14 -2.57 -4.67 4.53
No. of shares, average, diluted,
thousands 9,750 9,750 9,750 9,750 9,787
Net income (loss) -24.7 -11.1 -25.1 -45.5 44.3
Stock options issued - 0.5 - - 1.1
Change in accounting principles,
RR29 Employee Benefits -4.8 - - - -
Dividend -29.3 -29.3 - - -29.3
Currency translation differences 0.3 -19.2 -6.0 -3.4 -20.6
Change in shareholders' equity -58.5 -59.1 -31.1 -48.9 -4.5
Quarterly Income Statements
3Q 2Q 1Q 4Q 3Q 2Q 1Q
SEK million 2004 2004 2004 2003 2003 2003 2003
Sales 134.6 107.3 95.3 160.8 105.7 142.5 106.5
Cost of sales -29.0 -28.6 -24.3 -22.5 -18.4 -28.8 -24.3
Marketing -42.8 -44.9 -37.9 -45.2 -38.5 -43.1 -38.6
Administration -24.6 -15.4 -12.9 -17.2 -19.7 -18.8 -15.4
Research and development -57.0 -17.1 -19.0 -21.9 -18.9 -19.3 -18.5
Other income and expenses - -1.7 1.6 -4.5 -2.1 -3.2 -4.6
Amortization of goodwill -1.0 -1.0 -1.0 -1.0 -1.0 -1.0 -1.0
Items affecting comparability - - - 6.2 -64.7 - -
Operating income (loss) -19.8 -1.4 1.8 54.7 -57.6 28.3 4.1
Financial items, net 0.6 0.7 1.5 2.3 1.5 3.2 4.9
Income (loss) after financial
items -19.2 -0.7 3.3 57.0 -56.1 31.5 9.0
Income taxes -5.7 -1.5 -0.8 -1.5 10.6 -4.6 -1.6
Minority interest -0.2 - 0.1 -0.1 - - 0.1
Net income (loss) -25.1 -2.2 2.6 55.4 -45.5 26.9 7.5
Basic earnings (loss) per
share, SEK -2.57 -0.23 0.27 5.69 -4.67 2.76 0.77
Diluted earnings (loss) per
share, SEK -2.57 -0.23 0.27 5.67 -4.67 2.75 0.77
No. of shares, average, diluted,
thousands 9,750 9,750 9,772 9,767 9,750 9,773 9,770
Sales by region
Jan.-Sept. 3Q 2Q 1Q 4Q 3Q 2Q 1Q
SEK million 2004 2003 2004 2004 2004 2003 2003 2003 2003
Americas 133.7 159.2 45.7 40.0 48.0 69.4 52.8 65.2 41.2
Europe 134.3 93.3 52.3 47.7 34.3 43.2 22.6 39.8 30.9
Asia-Pacific 69.2 102.2 36.6 19.6 13.0 48.2 30.3 37.5 34.4
337.2 354.7 134.6 107.3 95.3 160.8 105.7 142.5 106.5
Biacore Consolidated Balance Sheets
September 30 Dec. 31
SEK million 2004 2003 2003
Intangible assets 63.1 59.0 70.0
Property, plant and equipment 105.9 111.6 111.9
Long-term investments 0.4 1.0 1.0
Other long-term assets 23.2 26.9 23.8
Other current assets 234.7 227.2 260.2
Liquid funds 341.9 345.8 352.5
Total assets 769.2 771.5 819.4
Shareholders' equity 571.7 575.6 630.2
Minority interest 0.9 0.7 0.8
Provisions 88.5 84.3 80.6
Liabilities 108.1 110.9 107.8
Total shareholders' equity and liabilities 769.2 771.5 819.4
Financial structure
Operating capital 270.7 254.0 306.0
Long-term investments 0.4 1.0 1.0
Net interest-bearing assets 290.9 307.1 312.3
Net payable and deferred income tax asset 10.6 14.2 11.7
Minority interest -0.9 -0.7 -0.8
Shareholders' equity 571.7 575.6 630.2
Biacore Consolidated Statements of Cash Flows
January-September Full year
SEK million 2004 2003 2003
Net income -24.7 -11.1 44.3
Less: Depreciation and amortization 27.9 24.1 31.8
Less: Write-downs, reversal of write-downs,
gains and losses 36.6 47.0 44.7
Change in working capital 31.5 13.8 -19.2
Other 0.1 -11.7 -14.9
Cash flows from operating activities 71.4 62.1 86.7
Purchase of intangible assets -45.4 -37.3 -50.1
Purchase of property, plant and equipment -7.1 -11.6 -16.4
Sales of property, plant and equipment 0.5 - -
Sales of long-term investments - 11.0 11.0
Cash flows from investing activities -52.0 -37.9 -55.5
Repayment of loan -0.7 -0.7 -1.0
Dividend -29.3 -29.3 -29.3
Cash flows from financing activities -30.0 -30.0 -30.3
Net change in liquid funds -10.6 -5.8 0.9
Key figures
Operating margin -5.8% -7.1% 5.7%
Return on operating capital -9.0% -11.6% 9.3%
Return on equity -5.5% -2.4% 7.0%
Equity ratio 74% 75% 77%
Shareholders' equity per share, diluted, SEK 58.59 58.81 64.34
No. of shares, thousands 9,750 9,750 9,750
No. of shares, end of period, diluted, thousands 9,758 9,788 9,794
No. of shares, average, diluted, thousands 9,750 9,750 9,787
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Dated: November 4, 2004
Biacore International AB (publ)
By: Lars-Olov Forslund
Name: Lars-Olov Forslund
Title: Chief Financial Officer