SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
Date of Report: March 3, 2000
BIORA AB
SE-205 12 Malmo, Sweden
Telephone: (011) 46-40-32-13-33
Indicate by a check mark whether the registrant files or will file
annual reports under cover of Form 20-F or Form 40-F.
|X| Form 20-F |_| Form 40-F
Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
|_| Yes |X| No
If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b):
Not applicable.
This Form 6-K consists of the fourth quarter report of Biora AB.
YEAR END REPORT 1999
BIORA AB (PUBL)
FEBRUARY 16, 2000
INCLUDING
NONRECURRING
REVENUE
1999 1998 1998
- ------------------------------------------------------------------------------
NET SALES, SEK MILLIONS 73.6 50.1 50.1
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OPERATING LOSS, SEK MILLIONS - 91.8 - 110.9 - 71.51)
- ------------------------------------------------------------------------------
NET LOSS, SEK MILLIONS - 86.7 - 99.4 - 60.01)
- ------------------------------------------------------------------------------
1) FIRST QUARTER OF 1998 INCLUDES NONRECURRING REVENUE FROM SEIKAGAKU
CORPORATION, BIORA'S JAPANESE PARTNER.
O SALES DURING 1999 INCREASED BY 47 PERCENT TO 73.6 (50.1)
MILLION SEK AND DURING THE FOURTH QUARTER BY 45 PERCENT TO
21.4 (14.7) MILLION SEK. THE INCREASE WAS MAINLY IN THE U.S.
MARKET (+ 89%).
O CLINICAL DISCOVERIES LEAD TO PILOT STUDIES WITH EMDOGAIN
RELATING TO THE HEALING OF CHRONIC WOUNDS AND WOUNDS
RESULTING FROM RADIATION TREATMENT.
O PILOT STUDIES SHOW THAT ENAMEL MATRIX PROTEINS STIMULATE
LOCAL BONE-FORMATION
O THE RIGHTS TO A NEW PATENT-PROTECTED PHARMACEUTICAL PROJECT
FOR DRY MOUTH (XEROSTOMIA) HAVE BEEN ACQUIRED.
O EMDOGAIN APPROVED IN THE USA FOR A NEW INDICATION, WHICH
MEANS A SIGNIFICANTLY INCREASED MARKET-POTENTIAL
O PREMIXED EMDOGAIN, EMDOGAIN(R)GEL, IS EXPECTED TO BE
LAUNCHED IN EUROPE DURING FIRST HALF OF 2000.
Biora develops, manufactures and sells products for the treatment of
periodontal disease and for use in oral surgery. Using its proprietary
technology and expertise, Biora aims to become a world leader in
biology-based products for specialized dental therapy. Biora's American
Depository Shares are listed on the Nasdaq National Market in the USA and
Biora's ordinary shares are listed on the "O-list" of the Stockholm Stock
Exchange in Sweden.
NEW VALUES IN BIORA
- -------------------
The two major positive highlights for Biora during 1999 have been the
results from our Research and Development and the sales increase in the
US-market. Progress in Europe, on the other hand, has been below our
expectations.
RESEARCH & DEVELOPMENT
Our Research and Development during 1999 has produced new and interesting
results. Our research on enamel matrix proteins, of which Emdogain is one,
suggests new areas of use in addition to treatment of periodontitis. The
new results also indicate potential areas of use outside of the oral
cavity.
USA
Approximately 170,000 patients have been treated with Emdogain. The market
in the USA is the most important for Biora and during 1999 sales increased
by 89 percent compared to 1998. Many American specialists now support
treatment with Emdogain, which has resulted in a large number of new
publications during 1999. During 2000 we will continue our efforts in the
US-market and intend to launch our new product, Emdogain(R)Gel, during the
year.
EUROPE
Sales development in Europe during 1999 was lower than our expectations,
particularly in the German market. The stagnation in Germany was mainly
because of a lack of focus on customer development. As a result we have
reorganized the management of the German subsidiary and at the same time
restructured the marketing organization in Europe.
The largest markets in Europe, Germany and Italy, still have the highest
priority. We now have a European marketing organization that coordinates
sales and marketing activities with our organization in the USA. I expect
that the launch of Emdogain(R)Gel will increase the pace of our
market-penetration in Europe as well as the USA.
BIORA.COM
Our homepage "biora.com" will play a significant role in our future sales
and marketing activities. The upgrading that is now taking place will
enable us to cultivate new, larger customer groups as well as patients in a
cost-effective manner.
TOMAS HAMMARGREN, CEO
YEAR END REPORT 1999
Biora's sales increased during 1999 to SEK 73.6 million compared to SEK
50.1 million in 1998. During the fourth quarter 1999 sales increased to SEK
21.4 million as compared to SEK 14.7 million during the same period in
1998. The sales increase was mainly in the US market.
SALES DURING 1998 AND 1999 PER QUARTER, SEK MILLIONS.
[GRAPHIC OMITTED]
DEVELOPMENT OF SALES BASED ON ROLLING TWELVE MONTHS FIGURES, SEK MILLIONS.
YEAR 1999
[GRAPHIC OMITTED]
Jan Feb March April May June July Aug Sept Oct Nov Dec
IMPORTANT PROGRESS IN RESEARCH AND DEVELOPMENT
During 1999 several of Biora's research-projects have yielded positive
results quickly. The Research and Development has been expanded and now
includes projects for development of products for wound healing, local hard
tissue formation and dry mouth (xerostomia), among others.
Clinical studies are ongoing for new dental indications for Biora's
principal product, Emdogain. These indications include increased treatment
of periodontitis, treatment of recession type defects, evulsed teeth,
periodontitis in connection with impacted wisdom teeth, and wound healing.
WOUND HEALING
The use of Emdogain is accompanied by perceptibly improved healing
following surgery. This effect occurs because the growth of certain
disease-causing bacteria is inhibited by direct contact with Emdogain, and
body cells in the presence of Emdogain increase the amount of growth
factors that promote healing. These characteristics open the possibility of
using Emdogain for the treatment of wounds outside the oral cavity, for
example chronic wounds and wounds from radiation treatment. Clinical pilot
studies are to begin in Scandinavia.
LOCAL BONE FORMATION
Biora has found in new pilot studies that certain enamel matrix proteins
stimulate local formation of new bone, even in and outside the oral cavity.
The continuing work is intended document the effect and to determine future
areas for indications. Biora is a part of a cooperation-project together
with four European universities which are applying for financing within the
European commissions fifth program.
DRY MOUTH (XEROSTOMIA)
As a further step in Biora's concentration on diseases of the oral cavity,
Biora has acquired the patent rights for a new method of treating dry mouth
(xerostomia). A normal flow of saliva plays a decisive role in the health
of the mouth, and therefore in the individual's well being. A greatly
reduced flow of saliva is accompanied by difficulty in swallowing and
speaking and causes great discomfort. In addition, dry mouth increases the
risk for various diseases in the oral cavity, such as caries and infections
in the mucous membrane.
Just as periodontitis, dry mouth is a secret, very common disease that
primarily affects a large number of the older population. Dry mouth is
estimated to affect approximately 15 percent of 50 year olds and
approximately 40 percent of those over 80. Dry mouth is also a common side
effect of many medicines and radiation treatment.
The acquired process is based on local application of a
cholinesterase-inhibitor, physiostagmin, that stimulates the production of
saliva from the thousands of small salivary glands in the oral mucous
membrane. Two Swedish professors from Gothenburg University, Jorgen Ekstrom
and Herbert Helander, developed the method.
Preliminary clinical studies on healthy volunteers as well as patients with
dry mouth have shown good results. The remaining work is to develop a final
formulation and clinical studies.
NEW SUBSIDIARY ESTABLISHED
To emphasize Biora AB's focus on the diseases in the oral cavity but at the
same time develop other indications, a new subsidiary, Biora BioEx AB, has
been formed. Biora BioEx, together with other partners, will continue
Biora's development of products for indications outside the oral cavity.
During 1999 Biora BioEx submitted documentation for new patents for
products for treatment in and outside of the oral cavity.
BIORA'S PRINCIPLE PRODUCT EMDOGAIN
- ----------------------------------
NEW KNOWLEDGE ABOUT EMDOGAIN AND ITS MECHANISM OF ACTION
During 1999 Biora presented new findings on Emdogain's mechanism of action.
According to these findings PDL-cells from the area between the dental root
and the jawbone (cells that are important for successful treatment) are
favored by growing in the presence of Emdogain, while the growth of
epithelial cells from the gingival margin (cells that can jeopardize the
treatment) is inhibited. This data is important for the understanding of
the product's function and for continued market penetration.
CONTINUED PROGRESS IN THE U.S. MARKET
North America is the most important and fastest growing market for Biora.
There are estimated to be approximately 4,000 periodontists in the United
States. Of those 2,550 had bought Emdogain at the end of the period. More
than half of them had bought Emdogain more than once.
Biora believes that the acceptance of Emdogain is growing in the United
States. During this year's AAP conference (American Academy of
Periodontology, the leading organization for periodontology) at the end of
September 1999, a number of periodontal opinion-leaders presented positive
results from their clinical experiences with the product. Approximately
6,000 periodontists and dentists from all over the world attended the
conference. In addition, several American specialists published articles
that confirmed Emdogain's positive effect in the surgical treatment of
periodontal disease.
EMDOGAIN APPROVED IN THE USA FOR NEW INDICATION
During 1999 the United States Food and Drug Administration (FDA) approved
Emdogain for use as an adjunct to minimally invasive surgery. This
indicates that Emdogain can be utilized in conjunction with routine scaling
and root planing procedures in the "aesthetic zone", which include the
teeth and gums which appear when a person smiles.
Biora estimates that the target group in the United States for the new area
of application is about 60,000 dentists. Approximately 17 million scaling
and root planing procedures are performed annually in the USA and Biora
estimates that half of those are in the aesthetic zone. An introduction is
expected during 2001.
BIORA'S AMERICAN SUBSIDIARY WON "1999 SWEDISH TRADE COUNCIL
NORTH AMERICA ANNUAL ACHIEVEMENT AWARD"
Biora, Inc., the North American subsidiary of Biora AB, was chosen as the
Swedish subsidiary of the year in the North American market. The Nominating
Committee made the following statement: "The company's successful strategy
has been to focus on clinical trials, education and the opinion leaders
within the periodontal profession."
INCREASED USAGE IN EUROPE AND JAPAN
In Germany approximately 6,900 customers had purchased Emdogain by the end
of 1999, and more than half of those had made more than one purchase.
Approximately 640 customers in Sweden had purchased Emdogain and of those
460 had made more than one purchase.
In Japan Biora's products are marketed through the Japanese biotech company
Seikagaku Corporation. According to Seikagaku, the number of customers was
slightly more than 1,100 at the end of the period, and 500 of those had
bought Emdogain more than once. During the third quarter of 1999 Seikagaku
had broadened the target group from 1,500 to 4,000 specialists and general
practitioners.
PRE-MIXED PRODUCT WILL BE LAUNCHED IN EUROPE DURING FIRST HALF OF 2000
Today Emdogain is delivered as two components, which the dentist mixes. To
simplify use Biora is developing a pre-mixed product, Emdogain(R) Gel.
Documentation for licensing the product in Europe has been submitted, and
Biora is now preparing for a launch of the product in Europe during first
half of year 2000. Documentation for licensing the product in the United
States is planned to be submitted during the first quarter of 2000
NET SALES
The Group's net sales during 1999 increased to SEK 73.6 million (1998: SEK
50.1 million). The increase is primarily attributable to increased sales in
the U.S. market. Sales growth in the German market has been unsatisfactory,
and top management of the German subsidiary has therefore been changed.
PROFIT/LOSS
Gross profit amounted to SEK 58.1 million (1998: SEK 39.3 million). The
improvement can be explained mainly by the increase in sales.
The operating loss amounted to loss of SEK 91.8 million (1998: loss SEK
71.5 million). Operating loss during the same period in 1998 includes
nonrecurring revenue from Biora's Japanese partner in an amount of SEK 39.4
million. (Operating loss for 1998 excluding the nonrecurring revenue was
SEK 110.9 million). Net financial items were SEK 5.2 million (1998: SEK
11.6 million). The decrease is explained by decreased interest bearing
assets and lower market interest rates.
Net loss after tax during the period amounted to SEK 86.7 million (1998:
loss SEK 60.0 million), corresponding to a loss per share of SEK 4.09
(1998: loss SEK 2.83) based on the average of number of shares outstanding.
(Net loss after tax during 1998 excluding nonrecurring revenue was SEK 99.4
million, corresponding to a loss per share of SEK 4.69).
Increased internal efficiency has led to lower costs of administration and
stable sales costs, while sales increased by 47%. R&D costs have increased
by SEK 2.2 million (7%) after deduction for accelerated depreciation of
capitalized R&D and the costs during 1998 relating to the registration of
Emdogain in the USA (SEK 6.3 million).
INVESTMENTS
Capital expenditures during 1999 totaled SEK 4.3 million (1998: SEK 5.8
million).
FINANCIAL POSITION
Net change in cash and cash equivalents during the period was negative, in
an amount of SEK 74.2 million (1998: negative SEK 99.3 million). At the end
of the report period the Group's liquid funds amounted to SEK 112.8 million
(1998: SEK 187.0 million), the equity/assets ratio was 78.3 percent (1998:
86.6 percent) and Group equity amounted to SEK 127.4 million (1998: SEK
214.0 million).
EMPLOYEES
As of December 31, 1999, Biora had 92 employees as compared to 85 employees
as of December 31, 1998.
PARENT COMPANY
Net sales for 1999 amounted to SEK 51.1 million (1998: SEK 36.1 million)
and its loss before appropriations and income taxes was SEK 79.4 million
(1998: loss SEK 103.0 million). The loss for 1998 includes nonrecurring
revenue of SEK 39.4 million from the Japanese distributor (The loss
exclusive of nonrecurring revenue was SEK 142.4 million).
Investments in fixed assets and patents were SEK 2.6 million (1998: SEK 3.6
million). Net change in cash and cash equivalents during 1999 was negative,
in an amount of SEK 77.9 million (1998: neg. SEK 100.3 million). At the end
of the reporting period the parent company's liquid assets amounted to SEK
103.6 million (1998: SEK 181.5 million), equity/assets ratio was 85.8%
(1998: 91.4%), and share holders' equity was SEK 145.4 million (1998: SEK
223.2 million).
DIVIDEND
The company does not have any non-restricted retained earnings therefore no
dividends shall be declared. The Board of Directors proposes that the
accumulated loss on the balance sheet, SEK 77.8 million, be covered by
charging the share premium reserve.
SCHEDULED FUTURE FINANCIAL INFORMATION
During 2000, Biora will publish financial information on the following
dates:
<TABLE>
<S> <C>
Annual Report (to be sent out by mail to shareholders) End of March/beginning of April
Interim report January - March May 4
Shareholder's meeting May 4
Interim report January - June August 18
Interim report January - September November 2
Investor's Day in Stockholm March 22 (New date!)
</TABLE>
Malmo, February 16, 2000
Biora AB (publ)
The Board of Directors
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This report may contain certain forward-looking statements that relate
to future events or future business and financial performance. Such
statements can only be predictions and the actual events or results
may differ from those discussed. The Company cautions that these
statements are subject to important factors that could cause actual
results to differ materially from those expressed or implied in such
forward-looking statements and are more fully discussed in periodic
reports filed with Securities and Exchange Commission.
-------------------------------------------------------------------------
PRESIDENT AND CEO INVESTOR RELATIONS U.S INVESTOR RELATIONS
TOMAS HAMMARGREN MIKAEL SJOBLOM ELISABETH LAVERS
+46 40 32 13 36 + 46 40 32 13 65 +1 203 977 7797
<TABLE>
<CAPTION>
CONSOLIDATED STATEMENTS OF
OPERATIONS
1999 1999 1998 1999 1998
(Swedish GAAP) Jan - Dec OCT - DEC Oct - Dec JAN - DEC Jan - Dec
(TUSD) 1) (TSEK) (TSEK) (TSEK) (TSEK)
Net sales 8 874 21 326 14 697 73 556 50 119
<S> <C> <C> <C> <C> <C>
- --------------------------------------------------------------------------------------------------------------------
Costs of goods sold -1 866 -3 811 -3 029 -15 470 -10 864
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GROSS PROFIT 7 008 17 515 11 668 58 086 39 255
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Selling expenses -10 952 -26 289 -26 428 -90 783 -89 622
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Administrative expenses -2 232 -6 075 -5 680 -18 505 -22 133
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Research and development costs -5 018 -12 074 -9 774 -41 597 -39 980
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Other operating income and expenses 2) 120 -35 225 994 40 952
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LOSS FROM OPERATIONS -11 075 -26 958 -29 989 -91 805 -71 528
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Financial net 630 999 2 874 5 220 11 572
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LOSS AFTER FINANCIAL ITEMS -10 445 -25 959 -27 115 -86 585 -59 956
- --------------------------------------------------------------------------------------------------------------------
Income tax -19 -122 -636 -154 -42
- --------------------------------------------------------------------------------------------------------------------
LOSS FOR THE PERIOD -10 464 -26 081 -27 751 -86 739 -59 998
- --------------------------------------------------------------------------------------------------------------------
</TABLE>
<TABLE>
<CAPTION>
CONSOLIDATED BALANCE
SHEETS
Dec 31, DEC 31, Dec 31,
(Swedish GAAP) 1999 1999 1998
(TUSD) 1) (TSEK) (TSEK)
<S> <C>> <C> <C>
Intangible long term assets 1 999 16 573 25 337
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Tangible long term assets 1 308 10 843 12 269
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Financial long term assets 306 2 534 2 571
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Total long term assets 3 613 29 950 40 177
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Inventories 624 5 175 4 174
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Current receivables 1 786 14 807 15 787
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Bank deposits 10 858 90 000 148 050
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Cash and bank 2 751 22 804 38 998
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Total current assets 16 020 132 786 207 009
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Total assets 19 633 162 736 247 186
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Shareholders' equity 15 371 127 406 213 970
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Provisions 54 444 397
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Long term liabilities 3) 22 185 155
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Current liabilities 3) 4 186 34 701 32 664
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Total shareholders' equity and liabilities 19 633 162 736 247 186
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</TABLE>
1) Average exchange rate Jan-Dec , 1999, USD 1 = 8,289
2) In the first quarter 1998 a nonrecurring revenue from Seikagaku
Corporation of 39,4 MSEK is included in other operating income and royalty
expense to Astra of 1,0 MSEK on this revenue is included in other operating
expenses.
3) Biora did not have any interest bearing liabilities neither on December
31, 1999 nor December 31, 1998.
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
CONSOLIDATED (TSEK) 1999 1998 1999 1998
(Swedish GAAP) OCT - DEC Oct - Dec JAN - DEC Jan - Dec
<S> <C> <C> <C> <C>
Loss for the period -26 081 -27 751 -86 739 -59 998
- -----------------------------------------------------------------------------------------------------------------------
Depreciation and amortization 1 474 1 449 5 552 5 156
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Change in capitalized research and development costs 3 267 731 8 595 2 924
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Prepaid nonrecurring revenue - - - -39 375
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Other adjustments to reconcile net loss to net cash flows
used in operating activities 419 796 541 241
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Change in assets and liabilities 7 804 10 2 447 -2 821
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NET CASH USED IN OPERATING ACTIVITIES -13 117 -24 765 -69 604 -93 873
- -----------------------------------------------------------------------------------------------------------------------
Capital expenditures (tangible assets and patents) -1 647 -1 370 -4 334 -5 842
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Other investing activities -63 -51 -29 -
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NET CASH USED IN INVESTING ACTIVITIES -1 710 -1 421 -4 363 -5 842
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NET CASH FROM FINANCING ACTIVITIES - 155 - 111
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Effect of exchange rate changes on cash and cash equivalents 59 175 -277 342
- -----------------------------------------------------------------------------------------------------------------------
NET CHANGE IN CASH AND CASH EQUIVALENTS -14 768 -25 856 -74 244 -99 262
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</TABLE>
<TABLE>
<CAPTION>
KEY RATIOS
Consolidated 1999 1998 1997 1996 1995
(Swedish GAAP) 1)
<S> <C> <C> <C> <C> <C>
Net sales (TSEK) 73 556 50 119 16 499 4 561 936
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R & D costs (TSEK) 2) 41 597 39 980 21 207 10 884 9 347
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Return on capital employed, % 3) -50,7 -40,0 -53,2 -266,2 -46,1
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Return on equity,% 4) -50,8 -40,0 -58,1 neg. -128,8
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Equity / assets ratio, % 5) 78,3 86,6 81,9 -34,2 28,8
- ------------------------------------------------------------------------------------------------------------------
Net debt / equity ratio, % 6) -88,5 -87,4 -103,0 -84,3 163,3
- ------------------------------------------------------------------------------------------------------------------
Total equity (TSEK) 127 406 213 970 277 935 -18 437 7 986
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Average number of shares
outstanding, (000s) 7) 21 204 21 204 20 571 14 207 10 819
- ------------------------------------------------------------------------------------------------------------------
Equity per share, SEK 7) 6,01 10,09 13,51 -1,30 0,74
- ------------------------------------------------------------------------------------------------------------------
Loss per share, SEK 7) -4,09 -2,83 -3,66 -2,61 -1,01
- ------------------------------------------------------------------------------------------------------------------
</TABLE>
1) Return on capital employed and return on equity have been
adjusted for the effect of the nonrecurring revenue from
Seikagaku.
2) R&D-costs are shown gross, including capitalized costs. During
1999, as well as during 1998, no costs have been capitalized
under the caption Capitalized R&D costs, which explains why the
net and gross costs were equal, 41,597. (2.5% royalty to Astra on
sales of Emdogain has been reclassified to costs of goods sold.)
3) Operating loss plus financial income divided by average total
assets (total assets less non-interest-bearing operating
liabilities including deferred taxes).
4) Net loss divided by average equity.
5) Shareholders' equity divided by total assets.
6) Interest-bearing liabilities less cash and bank deposits
divided by shareholders' equity.
7) The number of ordinary shares outstanding used in
determination of loss and equity per ordinary share is calculated
on a proforma basis by giving effect to a 25:1 share split and
the 3:1 stock dividend completed by the Company during 1996. The
dilution effects of outstanding convertible loans and options
have not been considered when calculating equity and loss per
share for the years 1995-1999 as this would reduce the loss per
share.
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 hereunto duly authorized.
BIORA AB
Dated: March 6, 2000 By: /s/ Anders Agering
-----------------------
Anders Agering
Chief Financial Officer
