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BioGaia

Quarterly Report Apr 22, 2009

3013_10-q_2009-04-22_a8f89ebf-c256-4a3c-9fa4-0bda8da285ab.pdf

Quarterly Report

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Press Release, 22 April, 2009 (10 pages) BioGaia AB Interim report, 1 January - 31 March 2009 (Figures in brackets refer to the same period of last year)

  • Net sales amounted to SEK 52.2 million (36.1), an increase of SEK 16.2 million (45%) compared to the same period of last year.
  • Operating profit was SEK 13.4 million (7.5), an improvement of SEK 5.9 million.
  • Profit after tax was SEK 15.1 million (8.0), an increase of SEK 7.1 million.
  • Profit after tax was SEK 10.4 million (8.0), an improvement of SEK 2.4 million. BioGaia pays no tax. The period's reported tax expense of SEK 4.7 million refers to a change in the deferred tax asset. Profit for the corresponding period of last year was charged with no reported income tax.
  • Earnings per share were SEK 0.61 (0.47).
  • The period's cash flow from operating activities before change in working capital was SEK 14.6 million (9.3). Total cash flow for the period was 7.6 million (3.5). Cash and cash equivalents at 31 March 2009 amounted to SEK 65.9 million.

Key events in the first quarter of 2009

  • BioGaia's subsidiary CapAble signs agreement with Aqua Scandik for the sale of LifeTop Cap with Reuteri in Mexico.
  • Study shows that BioGaia's Probiotic chewable tablets are effective in decreasing diarrhoea caused by antibiotics.
  • BioGaia product launched as pharmaceutical in India.
  • Agreement with Ewopharma for distribution of BioGaia's Probiotic tablets and drops in Serbia and Croatia.

No key events have taken place after the end of the reporting period.

"In spite of the ongoing financial crisis, the company has shown very positive development in the first quarter and we are seeing continued strong demand for our products" says Managing Director Peter Rothschild.

Latest press releases from BioGaia:

2009-03-18 Notice to attend the Annual General Meeting of BioGaia
2009-03-11 BioGaia signs distribution agreement for Serbia and Croatia
2009-03-04 BioGaia product launched as pharmaceutical in India

For additional information contact:

Peter Rothschild, Managing Director, telephone +46 8 - 555 293 00 Jan Annwall, Deputy Managing Director, telephone +46 8 - 555 293 00

BioGaia is a biotechnology company that develops, markets and sells probiotic products with documented health benefits. The products are primarily based on the lactic acid bacterium Lactobacillus reuteri (Reuteri), which has probiotic, health-enhancing effects. The class B share of the Parent Company BioGaia AB is quoted on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm. www.biogaia.com

BioGaia AB (publ.)

Interim report

1 January – 31 mars 2009

Figures in brackets refer to the same period of last year.

The Board of Directors and the Managing Director of BioGaia AB (publ) hereby present the interim report for the period from 1 January to 31 March 2009.

BioGaia AB

The company

BioGaia is a biotechnology company that develops, markets and sells probiotic products with documented health benefits. The products are primarily based on different strains of the lactic acid bacterium Lactobacillus reuteri (Reuteri) which has health-enhancing effects. BioGaia has also developed unique delivery systems, such as probiotic-containing straws and caps, that make it possible to create probiotic products with a long shelf life.

BioGaia has 43 employees, of whom 18 are based in Stockholm, 18 in Lund, 3 in Raleigh, USA, and 4 in Hiroshima, Japan.

The class B share of the Parent Company BioGaia AB is quoted on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm.

Business model

BioGaia's net sales consist mainly of revenue from the sale of finished consumer products (tablets, drops and oral health products) to distributors, but also of revenue from the sale of component products such as Reuteri cultures, straws and caps.

BioGaia's products are sold through nutrition, food, natural health and pharmaceutical companies in some 40 countries worldwide.

In Sweden, BioGaia's products are sold under the brands Semper Magdroppar and Gum PerioBalance chewing gum in pharmacies, as well as Semper whole grain cereal and infant formula with active culture and Probiomax gut health tablets in grocery stores.

BioGaia holds patents for the use of Reuteri and certain delivery systems in all major markets.

The BioGaia brand

BioGaia's licensees add Reuteri culture to their products and sell these under their own brand names. On these products, the BioGaia brand is shown on the package as the licensor/patent holder.

The majority of BioGaia's consumer products are sold to distributors, which then sell the products under their own brand names. For these products, the BioGaia brand is shown on the consumer package since BioGaia is both the manufacturer and licensor.

At the end of 2005 BioGaia launched its own consumer brand and today there are a number of distributors that sell BioGaia's finished products under the BioGaia brand. One central part of BioGaia's strategy is to increase the share of sales consisting of BioGaia-branded products. In the first quarter of 2009, 28 percent (22) of finished consumer products were sold under the BioGaia brand.

Research and clinical studies

BioGaia's research is focused on selection of different probiotics for gut health, the immune system and oral health. Extensive clinical studies have shown that BioGaia's various probiotic products:

  • stimulate the human immune system,
  • protect against GI tract and respiratory tract infections,
  • alleviate the side effects of antibiotic treatment,
  • reduce the level of H. pylori infection,
  • reduce the occurrence of infantile colic,
  • reduce the risk of infection and improve

gastrointestinal function in pre-term newborns, - reduce gum inflammation, plaque and the risk for dental caries.

KEY EVENTS IN THE FIRST QUARTER

Launches during the quarter

  • Ferring, BioGaia's Probiotic drops in Lebanon and Greece
  • Ferring, BioGaia's Probiotic tablets in Canada
  • BioLife, portion-packed bags containing colostrum and Reuteri in China

The length of time between contract and launch varies between countries due to differing amounts of time needed for the registration process. The products are normally registered as dietary supplements and in certain cases as pharmaceuticals.

Agreement with Aqua Scandik

In January 2009 CapAble signed an agreement with the Mexican water company Aqua Scandik giving them the rights to use LifeTop Cap with Reuteri. Aqua Scandik will launch water in three different flavours with Reuteri. The launch is expected to take place in early 2010.

Study shows that BioGaia's Probiotic chewable tablets are effective in decreasing diarrhoea caused by antibiotics

In a new double blind, placebo-controlled clinical study, supplementation with BioGaia's Probiotic chewable tablets containing L. reuteri was effective in reducing the incidence of diarrhoea in hospitalised patients who were treated with antibiotics. The study, which was performed at the University Hospitals Case Medical Center in Cleveland, Ohio, USA, was presented by Cimperman and colleagues at the Clinical Nutrition Week 2009 Conference on 1- 4 February in New Orleans.

Pharmaceutical in India

BioGaia has signed an agreement with Tablets India Ltd. for the production and sale of products based on BioGaia's probiotics on the Indian market. The launch is planned in the first half of 2009.

The first product to be launched on the Indian market is a capsule under the brand name Apylori Probiotic Capsules. The product is manufactured by Tablets India and registered as a pharmaceutical that will be prescribed by physicians and distributed through pharmacies.

Distribution agreement with Ewopharma for Serbia and Croatia

In March BioGaia extended its collaboration with the Swiss pharmaceutical company Ewopharma AG, giving the company exclusive rights to sell BioGaia's probiotic drops and tablets under the BioGaia brand in Serbia and Croatia.

Ewopharma already sells BioGaia's Probiotic tablets and drops in Poland, Slovakia, Hungary and Slovenia and BioGaia's Probiotic tablets in the Czech Republic. The products are sold under the BioGaia brand.

BioGaia Japan

Efforts are underway to adapt the business model in Japan to the model that has been used successfully in other markets. The strategy is to shift the focus from Functional Foods products in grocery stores to sales of drops and straws in pharmacies and drugstores. Although it is still too early to determine whether these measures will be successful, the current outlook is positive. These changes will not affect the existing distributors in Japan, Erina and Chichiyasu.

FINANCIAL PERFORMANCE IN THE FIRST QUARTER OF 2009

Consolidated net sales reached SEK 52.2 million (36.1), up by 45% compared to the same period of last year. Of the increase, SEK 4.6 million was attributable to rising exchange rates for EUR and JPY. Excluding currency effects, net sales strengthened by SEK 11.5 million (32%).

Compared to the previous quarter, net sales increased by SEK 13.0 million (33%).

BioGaia's finished consumer products in Europe accounted for most of the sales increase compared to the same period of last year.

Gross profit amounted to SEK 35.4 million (24.4), an improvement of SEK 10 million over the same period of last year. Of the increase in gross profit, SEK 2.8 million was attributable to exchange rate movements in EUR and JPY.

Selling expenses rose by SEK 3.0 million compared to the same period of last year, which is partly explained by an increase of SEK 1.3 million in costs for the Japanese venture, of which SEK 1.1 million is due to exchange rate movements in JPY, and partly by higher marketing and PR activity and somewhat higher personnel costs.

R&D expenses amounted to SEK 6.8 million (5.3), which is equal to 18% (19%) of total operating expenses. The higher R&D expenses are due to an increased level of activity in clinical studies that began during the quarter, as well as higher product development costs. The amortisation component of R&D expenses amounted to SEK 0.7 million (0.8). Investments in capitalised development expenses totalled SEK 0 million (0).

Operating profit was SEK 13.4 million (7.5), up by SEK 5.9 million over the same period of last year.

Profit before tax was SEK 15.1 million (8.0), which is SEK 7.1 million better than in the same period of last year. Net financial items include an unrealised foreign exchange gain of SEK 1.5 million on forward exchange contracts in EUR. The company has entered into forward exchange contracts for EUR 6.6 million at an average exchange rate of SEK 10.47. Forward exchange contracts amounting to EUR 3.6 million will mature in 2009 and the remaining EUR 3.0 million in 2010. The actual foreign exchange gain/loss depends on the exchange rate on the maturity date of the contracts. If the EUR rate on the maturity date is lower/higher than that at 31 March 2009 (10.96), a foreign exchange gain/loss will be recognised.

Profit after tax was SEK 10.4 million (8.0), an improvement of SEK 2.4 million compared to the same period of last year.

The Group pays no tax due to the existence of a cumulative loss carryforward. The reported

tax expense is attributable to a change in the deferred tax asset.

Earnings per share amounted to SEK 0.61 (0.47). A total of 128,950 warrants have been subscribed for in BioGaia's ongoing incentive scheme. Since the current share price is significantly lower than the subscription price, the outstanding options have no dilutive effect.

The Group's cash and cash equivalents at 31 March 2009 totalled SEK 65.9 million (46.5).

Cash flow for the quarter was SEK 7.6 million (3.5), an improvement of SEK 4.1 million compared to the same period of last year.

Cash flow from operating activities before change in working capital was SEK 14.6 million (9.3), up by SEK 5.3 million over the same period of last year. The increase in working capital was SEK 6.6 million and is mainly attributable to trade receivables.

Consolidated equity amounted to SEK 143.5 million (102.9). The Group's equity/assets ratio was 88% (85%).

Capital expenditure on property, plant and equipment totalled SEK 0.4 million (1.4).

The Parent Company reported net sales of SEK 50.3 million (36.2) and a profit after net financial items of SEK 14.4 million (9.8).

EMPLOYEES

The number of employees at 31 March 2009 was 43 (37).

SIGNIFICANT RISKS AND UNCERTAINTIES; GROUP AND PARENT COMPANY

No major changes in significant risks and uncertainties have taken place during the period. See pages 4 and 5 and Note 30 of the annual report for 2008.

ACCOUNTING POLICIES

The consolidated financial statements have been prepared in compliance with the International Financial Reporting Standards (IFRS) established by the International Accounting Standards Board (IASB) and the interpretations published by the International Financial Reporting Interpretations Committee (IFRIC) that have been endorsed by the European Commission for application in the EU.

This interim report has been prepared for the Group in accordance with IAS 34, Interim Financial Reporting, and the Annual Accounts Act, and for the Parent Company in accordance with the Annual Accounts Act.

Unless otherwise stated below, the Group and the Parent Company apply the same

accounting and valuation standards as in the 2008 annual report.

New accounting standards:

The revised IAS 1, Presentation of Financial Statements, is applied with effect from 1 January 2009. Among other things, the revision means that income and expenses that were previously recognised directly in equity are now recognised in connection with the income statement.

IFRS 8, Operating Segments, is applied with effect from 1 January 2009. The standard requires adaptation of segment information to the reporting used internally by the company's management for monitoring of operations. The application of IFRS 8 has led to a change in the operating segments so that these now consist of the following:

  • Finished consumer products: sales of tablets, drops and oral health products, etc.
  • Component products: sales of cultures as an ingredient in licensee products, products (such as baby formula and dairy products), royalty income from the use of Reuteri and sales of LifeTop Straw and Life Top Cap.
  • Other products: Animal Health, etc.

The application of IFRS 8 has not had any impact on the Group's profit, financial position, cash flow or changes in equity.

FUTURE OUTLOOK

BioGaia's goal is to create strong value growth and a good return for the shareholders. This will be achieved through a greater emphasis on the BioGaia brand, increased sales to both existing and new customers and a controlled cost level.

The financial target is to achieve a sustainable profit margin of 25% within a period of 3 to 5 years, with continued strong growth and increased investments in research, product development and brand building. BioGaia's ambition is to pay a shareholder dividend equal to 30% of profit after actual paid tax.

Product launches in a large number of countries are expected to take place during 2009.

In view of the Company's strong portfolio consisting of an increased number of innovative products partly under the company's own brand, together with successful clinical trials and growing distribution network covering a large share of the key markets, BioGaia's future outlook is bright.

CONSOLIDATED STATEMENTS OF
COMPREHENSIVE INCOME
Jan-Mar Jan-Mar Jan-Dec
(Amounts in SEK 000s) 2009 2008 2008
Net sales 52,233 36,079 145,190
Cost of goods sold -16,792 -11,657 -48,234
Gross profit 35,441 24,422 96,956
Other operating income - 164 4,059
Selling expenses -12,314 -9,297 -43,617
Administrative expenses -2,455 -2,210 -8,193
Research and development expenses -6,841 -5,279 -23,030
Other operating expenses -379 - -
Share in profit/loss of associated company -90 -260 -334
Operating profit 13,362 7,540 25,841
Financial income and expenses 1,758 474 -1,811
Profit before tax 15,120 8,014 24,030
Tax expense for the period -4,690 - 12,091
PROFIT FOR THE PERIOD 10,430 8,014 36,121
Other comprehensive income
Gains and losses arising from translating the
financial statements of a foreign operation 694 - 1,290
Comprehensive income for the period 11,124 8,014 37,411
Profit for the period attributable to:
Equity holders of the Parent Company 10,430 8,014 36,121
Minority interests - - -
10,430 8,014 36,121
Comprehensive income for the period attributable to:
Equity holders of the Parent Company 11,124 8,014 37,411
Minority interests - - -
11,124 8,014 37,411
Earnings per share
Basic earnings per share (average number of
shares), SEK
0.61 0.47 2.10
Diluted earnings per share, SEK 0.61 0.47 2.10
Number of shares, thousands 17,208 17,208 17,208
Average number of shares, thousands
Average number of shares after dilution,
17,208 17,208 17,208
thousands 17,208 17,208 17,208
CONSOLIDATED BALANCE SHEETS 31 March 31 Dec 31 March
(Amounts in SEK 000s) 2009 2008 2008
ASSETS
Intangible assets 4,339 5,050 7,399
Tangible assets 4,036 3,936 3,781
Shares in associated company 7,761 7,851 6,325
Non-current receivables from associated company 4,400 4,400 4,400
Deferred tax asset 16,410 21,100 9,000
Other non-current receivables 50 47 25
Current assets excl. cash and cash equivalents 59,572 53,795 43,985
Cash and cash equivalents 65,865 58,127 46,487
TOTAL ASSETS 162,433 154,306 121,402
EQUITY AND LIABILITIES
Equity attributable to equity holders in the Parent
Company
143,445 132,321 102,924
Minority interests 99 99 -
Total equity 143,544 132,420 102,924
Interest-free current liabilities 18,889 21,886 18,478
TOTAL EQUITY AND LIABILITIES 162,433 154,306 121,402
CONSOLIDATED CASH FLOW
STATEMENTS
Jan-Mar Jan-Mar Jan-Dec
(Amounts in SEK 000s) 2009 2008 2008
Operating activities
Operating profit 13,362 7,540 25,841
Depreciation/amortisation 979 1,020 4,260
Capital gains/losses on the sale of non-current
assets
- 7 7
Share in profit/loss of associated company 90 260 334
Other non-cash items -61 28 -407
Interest received and paid 271 474 2,381
Cash flow from operating activities before
changes in working capital
14,641 9,329 32,416
Changes in working capital -6,639 -3,411 -13,212
Cash flow from operating activities 8,002 5,918 19,204
Cash flow from investing activities -354 -2,398 -4,966
Cash flow from financing activities - - 99
Cash flow for the period
Cash and cash equivalents at beginning of
7,648 3,520 14,337
period
Exchange differences in cash and
58,127 42,977 42,977
cash equivalents 90 -10 813
Cash and cash equivalents at end of period 65,865 46,487 58,127

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

(Amounts in SEK 000s) Jan-Mar Jan-Mar Jan-Dec
2009 2008 2008
At beginning of year 132,420 94,910 94,910
New share issue in CapAble - - 99
Comprehensive income for the period 11,124 8,014 37,411
At end of period 143,544 102,924 132,420

Segment reporting – Group

Since 2003 the company has had only one operating segment, Animal & Human Health, which consisted of the Human Health and Animal Health market units.

Starting on 1 January 2009, the Group has implemented IFRS 8 Operating Segments. The Group Management has analysed the Group's internal reporting and established that the Group's operations are steered and evaluated based on the following segments:

  • Finished consumer products: sales of tablets, drops and oral health products, etc.

  • Component products: sales of cultures as an ingredient in licensee products, products (such as baby formula and dairy products), royalty income from the use of Reuteri and sales of LifeTop Straw and Life Top Cap.

  • Other products: Animal Health, etc.
Revenue by segment Jan-Mar Jan-Mar Jan-Dec
2009 2008 2008
Consumer products 42,846 27,425 106,325
Input products 9,278 8,145 36,931
Other products 109 509 1,934
52,233 36,079 145,190
Jan-Mar Jan-Mar Jan-Dec
Gross profit by segment 2009 2008 2008
Consumer products 28,739 17,809 68,728
Input products 6,598 6,157 26,631
Other products 104 456 1,597
35,441 24,422 96,956
31 Mar 31 Mar 31 Dec
Trade receivables by segment 2009 2008 2008
Consumer products 28,657 19,354 20,401
Input products 5,514 3,905 8,050
Other products 36 139 394
34,207 23,398 28,845
Revenue by geographical market
(Amounts in SEK 000s) Jan-Mar Jan-Mar Jan-Dec
Sales 2009 2008 2008
Europe 35,186 28,154 93,973
USA and Canada 3,967 372 8,851
Asia 9,647 6,837 30,618
Rest of world 3,433 716 11,748
52,233 36,079 145,190
PARENT COMPANY INCOME STATEMENTS Jan-Mar Jan-Mar Jan-Dec
2009 2008 2008
Net sales 50,343 36,176 143,586
Cost of goods sold -15,508 -11,651 -47,211
Gross profit 34,835 24,525 96,375
Selling expenses -8,682 -8,203 -36,035
Administrative expenses -2,422 -2,210 -8,167
Research and development expenses -6,913 -5,287 -23,042
Other operating income - 164 4,059
Other operating expenses -406 - -
Operating profit 16,412 8,989 33,190
Result from shares in associated company - - -334
Result from shares in subsidiary - - -569
Write-down of receivable from subsidiary -4,047 - -13,467
Net financial items 1,991 766 -1,008
Profit before tax 14,356 9,755 17,812
Tax expense for the period -4,840 - 11,660
PROFIT FOR THE PERIOD 9,516 9,755 29,472
PARENT COMPANY BALANCE SHEETS 31 Mar 31 Mar 31 Dec
2009 2008 2008
ASSETS
Intangible assets 4,339 7,399 5,050
Tangible assets 2,497 3,474 3,581
Shares in group companies 4,469 4,137 4,469
Shares in associated companies 7,851 6,585 7,851
Non-current receivables from subsidiary 1,022 2,840 -
Non-current receivables from associated company 4,400 4,400 4,400
Deferred tax asset 15,820 9,000 20,660
Current assets excl. cash and cash equivalents 54,914 42,017 51,017
Cash and cash equivalents 63,950 45,876 55,293
TOTAL ASSETS 159,262 125,728 152,321
EQUITY AND LIABILITIES
Shareholders' equity 133,896 104,663 124,380
Interest-free current liabilities 25,366 21,065 27,941
TOTAL EQUITY AND LIABILITIES 159,262 125,728 152,321

Pledged assets and contingent liabilities for the Parent Company

Floating charges 2,000 2,000 2,000
Contingent liabilities None None None
PARENT COMPANY CASH FLOW STATEMENTS Jan-Mar Jan-Mar Jan-Dec
2009 2008 2008
Operating activities
Operating profit 16,412 8,989 33,190
Depreciation/amortisation 913 1 005 4,141
Capital gains/losses on the sale of non-current assets - 7 7
Other non-cash items -61 28 -407
Interest received and paid 274 766 2,367
Cash flow from operating activities before changes in
working capital
17,538 10,795 39,298
Changes in working capital -5,133 -3,081 -10,128
Cash flow from operating activities 12,405 7,714 29,170
Cash flow from investing activities -3,809 -3,913 -16,388
Cash flow from financing activities - - -
Cash flow for the year 8,596 3,801 12,782
Cash and cash equivalents at beginning of year 55,293 42,103 42,103
Exchange differences in cash and cash equivalents 61 -28 408
Cash and cash equivalents at end of year 63,950 45,876 55,293

PARENT COMPANY STATEMENT OF CHANGES IN EQUITY

(Amounts in SEK 000s) Jan-Mar Jan-Mar Jan-Dec
2009 2008 2008
At beginning of year 124,380 94,908 94,908
Profit for the period 9,516 9,755 29,472
At end of period 133,896 104,663 124,380

RELATED PARTY TRANSACTIONS, GROUP AND PARENT COMPANY (Amounts in SEK 000s)

The Group has a 50% holding in TwoPac AB, which is reported as an associated company.

The following transactions have taken place with TwoPac AB.

Jan-Mar Jan-Mar Jan-Dec
2009 2008 2008
Interest income 36 70 285
Conditional shareholder contributions paid - 1,000 2,000
Advance payment converted to shareholder contribution - - 600
Purchase of goods 2 460 925 8,952
Purchase of machinery and equipment - - 221
The closing balance at the end of the period was as
follows:
31-mar 31-mar 31-dec
Non-current receivables from TwoPac AB 2009 2008 2008
Non-current receivables from TwoPac AB 4,400 4,400 4,400
Current transactions with related parties
Current receivables from TwoPac AB 36 70 65
Current liabilities to TwoPac AB -240 -155 -118
-204 -85 -53
CONSOLIDATED KEY RATIOS 1) Jan-Mar
2009
Jan-Mar
2008
Jan-Dec
2008
Return on
- average shareholders' equity 7.6% 8.1% 31.8%
- average capital employed 9.9% 8.1% 25.1%
Capital employed, SEK 000s 143,544 102,924 132,420
Number of shares, thousands 17,208 17,208 17,208
Average number of shares, thousands 17,208 17,208 17,208
Number of outstanding warrants, thousands 129 129 129
Average number of outstanding warrants with a
dilutive effect, thousands
- - -
Average number of shares after dilution,
thousands
17,208 17,208 17,208
Basic earnings per share, SEK 0.61 0.47 2.10
Diluted earnings per share, SEK 0.61 0.47 2.10
Equity per share, SEK 8.34 5.98 7.69
Diluted equity per share, SEK 8.34 5.98 7.69
Equity/assets ratio 88% 85% 86%
Average number of employees 43 37 39

1) The definitions of key ratios correspond to those in the annual report.

FINANCIAL CALENDAR

18 August 2009 Interim report 1 January - 30 June 2009
22 October 2009 Interim report 1 January - 30 September 2009
18 February 2010 Year-end report 2009

Stockholm, 22 April 2009

The Board of Directors and Managing Director

This interim report has not been examined by the Company's independent auditors.

The information in this interim report was submitted for publication on 22 April, 2009, 8.15 a.m. CET.

BioGaia AB Box 3242 SE-103 64 STOCKHOLM, Sweden Street address: Kungsbroplan 3A, Stockholm Telephone: +46 (0)8 555 293 00 Corp. identity no. 556380-8723 www.biogaia.se

For additional information contact: Peter Rothschild, Managing Director, telephone: +46 (0)8 - 555 293 00, Jan Annwall, Deputy Managing Director, telephone: +46 (0)8 - 555 293 00

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