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BioGaia

Quarterly Report Oct 23, 2013

3013_10-q_2013-10-23_b0214e16-4307-40a2-9dc7-9b147c0dcfa0.pdf

Quarterly Report

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Press Release, 23 October 2013

BioGaia AB Interim report 1 January - 30 September 2013 (15 pages)

(Figures in brackets refer to the same period of last year)

President's comments:

"As I have pointed out before, we monitor our own performance based on the rolling 12-month figures. Sales of finished consumer products grew by 12%, excluding foreign exchange effects, and component products fell by 25% (due to the Nestlé deal in 2012). But we are aiming higher. In view of the development in most of the countries where we are active and the new product launches we are planning, we have no intention of changing this ambition," says Peter Rothschild, President of BioGaia.

Period from 1 January to 30 September 2013

Net sales reached SEK 225.7 million (216.81)), an increase of SEK 8.9 million (4%). Excluding foreign exchange effects, net sales improved by 7%.

Net sales of finished consumer products amounted to SEK 181.1 million (172.0), representing growth of SEK 9.1 million (5%). Excluding foreign exchange effects, net sales improved by 9%.

Net sales of component products amounted to SEK 43.6 million (43.81)), a decrease of SEK 0.2 million (0.5%). Excluding foreign exchange effects, net sales rose by 1%.

Operating profit was SEK 57.9 million (58.91)), down by SEK 1.0 million (2%). Excluding foreign exchange effects, operating profit improved by 2%.

Profit after tax was SEK 47.9 million (51.71)), a decrease of SEK 3.8 million (7%).

Earnings per share totalled SEK 2.63 (2.881)).

The period's total cash flow was SEK -131.7 million (233.3). Last year's cash flow included payment of SEK 356.0 million in licence revenue from Nestlé. Cash and cash equivalents at 30 September 2013 totalled SEK 243.2 million (404.1). Cash flow since 30 September 2012 includes dividends of SEK 172.7 million, tax payments of SEK 37.7 million, equipment investments in TwoPac of SEK 13.3 million and the acquisition of shares in TwoPac of SEK 30.0 million.

Third quarter of 2013

Net sales amounted to SEK 62.2 million (62.8), down by SEK 0.6 million (1%). There were no material foreign exchange effects on sales in the quarter.

Net sales of finished consumer products totalled SEK 46.4 million (50.2), a decrease of SEK 3.8 million (8%).

Net sales of component products amounted to SEK 15.7 million (12.5), an improvement of SEK 3.2 million (26%).

Operating profit was SEK 13.8 million (13.5), an increase of SEK 0.3 million (2%). Excluding foreign exchange effects, operating profit decreased by 3%.

Profit after tax was SEK 13.4 million (14.2), a decrease of SEK 0.8 million (6%).

Key events in the third quarter of 2013

BioGaia acquires remaining 50% of TwoPac.

FDA approves BioGaia's request for orphan drug designation.

New study shows that Lactobacillus reuteri Prodentis improves treatment of patients with periodontal disease.

Key events after the end of the third quarter

Meta-analysis regarding Lactobacillus reuteri Protectis and colic.

1) Excluding license revenue from Nestlé. Net sales and profit for the previous year also included license revenue of SEK 356.0 million from Nestlé for a perpetual license to use Lactobacillus reuteri Protectis in infant formula during the remaining term of the patent, which is regarded as nonrecurring revenue. Including license revenue from Nestlé, net sales for the period January-September 2012 amounted to SEK 572.8 million, operating profit to SEK 414.9 million, profit after tax to SEK 314.1 million and earnings per share to SEK 18.07.

Teleconference: You are welcome to take part in a teleconference on the interim report that will be held today at 9:30 a.m. by President Peter Rothschild. To participate in the conference, please see www.biogaia.com/agenda.

BioGaia has published this information in accordance with the Swedish Securities Market Act. The information was issued for publication on 23 October 2013, 8:00 a.m. CET.

This is a translation of Swedish version of the interim report. When in doubt, the Swedish wording prevails.

BioGaia AB (publ.)

INTERIM REPORT 1 JANUARY – 30 SEPTEMBER 2013

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

The Board of Directors and the President of BioGaia AB (publ) hereby present the interim report for the period from 1 January to 30 September 2013. A description of the company's operations is provided on page 15.

PRESIDENT'S COMMENTS

Sales of component products grew by 26% during the quarter and we can clearly see that our strategy of spreading risks in terms of the type and number of products, new products launches and geographical markets has given us a more stable situation than would otherwise be the case and is commonly seen in our industry.

Sales of finished consumer products fell by 8% during the quarter, most of which was offset by the increase for component products. One explanation behind this, for us unusual, development is decrease of sales to Italy, which is due to reduction of inventory at our distributor there and also the difficult economic situation in Italy. It is naturally difficult to predict when the Italian market will recover, but in September sales of our products in pharmacies returned to normal levels. We have also noted declining sales in Poland as a result of aggressive price competition.

As I have pointed out before, we monitor our own performance based on the rolling 12-month figures. Sales of finished consumer products grew by 12%, excluding foreign exchange effects, and component products fell by 25% (due to the Nestlé deal in 2012). But we are aiming higher. In view of the development in most of the countries where we are active and the new product launches we are planning, we have no intention of changing this ambition. Firstly, we are continuing the work to develop new and innovative products and secondly, we are focusing on introducing our products in several of the major markets such as the BRIC countries, the USA and the UK. When assessing our sales, it is important to keep in mind that the contract we signed with Nestlé in February 2012 means that they bought the license in the infant nutrition area, which gave a revenue and profit of SEK 356 million in 2012. If we had not made the sale, part of that sum would have increased our sales and profit for this year.

During the summer, Nestlé's subsidiary Gerber launched our colic drops for small children in the USA. After a few initial logistical problems, Gerber can now focus on marketing both through its own large force of sales representatives that visit doctors and through more traditional consumer marketing. It is encouraging to see that the first deliveries to Gerber have already essentially resulted in a doubling of sales compared to deliveries to the former distributor last year.

The results of a highly interesting study on patients with periodontal disease were reported during the quarter. The study compared patients receiving only standard treatment to patients being treated with a combination of BioGaia's oral health products and standard treatment. The patients who were given the BioGaia product as an adjunct showed better results on gingival pocket depth leading to a 53% decreased need for surgery. This study will further supplement the 22 studies that we have previously reported on in the oral health area, giving us access to fantastic marketing material that we use to convince dentists to recommend our oral health products to their patients.

In August the FDA approved our request for an orphan drug designation for a product that is intended for premature infants with the deadly disease NEC. This confers a number of advantages should BioGaia choose to register the product as a pharmaceutical. We are currently working to assess the financial investment and amount of time necessary to develop the product as a drug, and a plan of action for making this happen. As pharmaceuticals are not part of BioGaia's current business activities, the company is

exploring how a possible development process should continue in order to avoid deflecting attention from the core business. For this purpose, all business related to this field is handled by the subsidiary Infant Bacterial Therapeutics AB. During the year the project has cost just over SEK 2 million.

FINANCIAL PERFORMANCE DURING THE PERIOD FROM JANUARY TO SEPTEMBER 2013

Sales

Consolidated net sales reached SEK 225.7 million (216.8) (excluding the previous year's licence revenue from Nestlé), which is an increase of SEK 8.9 million (4%).

Most of the company's sales are denominated in foreign currency, primarily EUR but also USD and JPY. With unchanged exchange rates, net sales would have been SEK 7.0 million higher. Excluding foreign exchange effects, net sales (excluding license revenue) thus increased by 7%. Exchange rate fluctuations for EUR, USD and JPY reduce both revenue and expenses. Operating profit would have been SEK 2.4 million higher in the event of unchanged exchange rates, which is an increase of 2% compared to the same period of last year.

Including license revenue from Nestlé, net sales for the period from January to September 2012 amounted to SEK 572.8 million. Net sales for 2012 included license revenue from Nestlé of SEK 356 million that is regarded as non-recurring revenue. In February 2012 BioGaia signed several new agreements with Nestlé including the acquisition of a perpetual license to use BioGaia's probiotic in infant formula during the remaining term of the patent. The purchase price was EUR 50.8 million, of which EUR 40.0 million (SEK 356 million) was received and recognised in the first quarter of 2012. The additional payments of EUR 10.8 million will be received during the period 2014-2017 on the achievement of predefined milestones. Following the sale of the license, culture sales to Nestlé have fallen since the third quarter of 2012 due to a significantly lower margin on these sales.

Sales by segment

FINISHED CONSUMER PRODUCTS

Sales of finished consumer products rose by SEK 9.1 million (5%) compared to the same period of last year and amounted to SEK 181.1 million. Excluding foreign exchange effects, the increase was 9%.

Sales of finished consumer products grew primarily in Europe and "Rest of world". Sales also rose somewhat in Asia, but fell in the USA and Canada.

Sales in Europe increased in Finland, Ukraine, Sweden, Turkey and France, but fell in Italy and Poland. The decrease in Italy is due to reduction of inventory at the distributor and also the difficult economic situation in the country. In Poland, sales have declined as a result of aggressive price competition. The increase in "Rest of world" is mainly attributable to South Africa. In Asia, sales were up in Indonesia but declined in Japan.

The decrease in the USA and Canada is a result of lower sales of tablets to Fleet, since the company purchased large inventories in connection with the launch last year. The first deliveries to the new distributor of drops in the USA, Gerber, took place in the second and third quarters of 2013 and were roughly twice as high as deliveries to the former distributor during January-September 2012.

For the past 12-month period, sales of finished consumer products have risen by 7%. Excluding foreign exchange effects, the increase was 12%.

COMPONENT PRODUCTS

Sales of component products were down by SEK 0.2 million to SEK 43.6 million (0.5%) compared to the same period of last year (excluding the previous year's licence revenue from Nestlé). Excluding foreign exchange effects, net sales were up by 1%.

Sales rose somewhat in Europe but declined in Asia due to expiration of a contract with a dairy in Taiwan.

Earlier in the year, sales of component products decreased mainly as a consequence of the agreement with Nestlé in 2012 (see above). However, due to revenue arising from the new agreement with Nestlé (see below), net sales from Nestlé are now on the same level as in the previous year. The agreement now in force gives Nestlé the right to manufacture L. reuteri for use in infant nutrition, which would result in lower sales of cultures. BioGaia has no information about when Nestlé will exercise this right.

For the past 12-month period, sales of component products have decreased by 26% (25% including foreign exchange effects), which is a result of the license agreement with Nestlé in 2012.

Sales by geographical market

Sales in Europe increased by SEK 10.7 million (7%) (excluding the previous year's licence revenue from Nestlé). Sales of finished consumer products rose, while sales of component products increased marginally. For the past 12-month period, sales in Europe fell by 1% (excluding license revenue from Nestlé).

Sales in the USA and Canada were down by SEK 7.1 million (34%), which is due to lower sale to Fleet (see above). Sales to the new distributor of drops in the USA, Gerber, almost doubled compared to sales to the former distributor in the same period of last year, which has reduced the decrease in the USA and Canada. For the past 12-month period, sales were down by 27%.

Sales in Asia were largely unchanged. For the past 12-month period, sales in Asia declined by 4%.

Sales in "Rest of world" improved by SEK 5.3 million (29%), which is explained by higher sales of finished consumer products mainly in South Africa. For the past 12-month period, sales increased by 27%.

The BioGaia brand

Of total finished consumer products, 55% (51) were sold under the BioGaia brand, including so-called co-branding.

Gross profit

Gross profit amounted to SEK 155.1 million (153.0) (excluding the previous year's licence revenue from Nestlé) which is an increase of SEK 2.1 million (1%) compared to the same period of last year. Including licence revenue from Nestlé, gross profit for January-September 2012 was SEK 509.0 million.

The total gross margin (excluding license revenue) fell somewhat from 71% to 69%.

The gross margin for finished consumer products decreased from 72% to 71%. This is due to a lower margin in the third quarter since BioGaia's partner in Japan, Nippon Access, launched yoghurt products with a lower margin during the period.

The gross margin for component products decreased from 65% to 58%. This is due to a lower margin on sales of culture to Nestlé, since BioGaia sells the culture at a significantly lower price following the sale of the perpetual license for use of Lactobacillus reuteri Protectis in infant formula. However, gross margin increased during the third quarter mainly as a result of revenue under the new agreement with Nestlé.

Operating expenses

Selling expenses were up by SEK 0.7 million (1%) to SEK 56.6 million (55.9), which is equal to 25% (26) of net sales. Personnel expenses increased, while costs for marketing activities decreased. For the past 12-month period, selling expenses rose by 5%.

Administrative expenses amounted to SEK 10.6 million (9.7), which is equal to 5% (4) of net sales. The increase of SEK 0.9 million (9%) is attributable to higher personnel expenses. For the past 12-month period, administrative expenses grew by 3%.

R&D expenses are reported at SEK 30.9 million (25,2), which is equal to 14% (12) of net sales. The increase of SEK 5.7 million (23%) is mainly due to increased external expenses for research and clinical studies, but also higher personnel expenses. Expenses of SEK 2.1 million (0) for the Necrotising enterocolitis (NEC) project are included in the period. For the past 12-month period, R&D expenses rose by 18 %. The amortisation component of R&D expenses was SEK 0.3 million (0.5). Investments in capitalised development expenses totalled SEK 0 million (0).

Other operating income/expenses refer to foreign exchange losses on operating receivables and liabilities.

Operating profit

Operating profit was SEK 57.9 million (58.9) (excluding the previous year's licence revenue from Nestlé), which is SEK 1.0 million (2%) lower than in the same period of last year.

Including licence revenue from Nestlé, operating profit for January-September 2012 was SEK 414.9 million.

Financial items and profit before tax

Profit before tax was SEK 61.9 million (72.7) (excluding the previous year's licence revenue from Nestlé), which is SEK 10.8 million (15%) lower than in the same period of last year.

Including licence revenue from Nestlé, profit before tax for January-September 2012 was SEK 428.7 million.

Net financial items include a foreign exchange gain of SEK 0.1 million (7.3) on forward exchange contracts in EUR, which is SEK 7.2 million lower than for the same period of last year. At 30 September 2013 the company had outstanding forward exchange contracts for EUR 13.8 million at an average exchange rate of SEK 8.79. Forward exchange contracts amounting to EUR 2.7 million will mature for payment in 2013, EUR 8.4 million in 2014 and the remaining EUR 2.7 million in 2015. The actual 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 30 September 2013 (8.70), an exchange gain/loss will be recognised in the future.

Profit after tax

Profit after tax was SEK 47.9 (51.7) million (excluding the previous year's licence revenue from Nestlé), which is SEK 3.8 million (7%) lower than in the same period of last year.

Including licence revenue from Nestlé, profit after tax for the same period of last year was SEK 314.1 million.

The tax rate for the Group was 23% (29). The Group pays tax on profits in the Swedish companies. The Swedish companies have made provisions to untaxed reserves in 2012. For this, deferred tax of SEK 24.6 million has been recognised.

The loss in Japan is not deductible against the Swedish profits. Loss carryforwards in the Japanese subsidiary at 30 September 2013 amounted to SEK 59.7 million. The deferred tax asset for these has not been recognised, since a sustainable profit level has not yet been shown in the Japanese subsidiary.

Earnings per share

Earnings per share amounted to SEK 2.63 (2.88) (excluding the previous year's licence revenue from Nestlé). Including license revenue from Nestlé in 2012, earnings per share for January-September 2012 were SEK 18.07.

Cash flow

The Group's cash and cash equivalents at 30 September 2013 totalled SEK 243.2 million (404.1). Cash flow for the period amounted to SEK -131.7 million (233.3). The nine-month period of 2012 included the payment of SEK 356.0 million in licence revenue from Nestlé.

Cash flow since 30 September 2012 includes dividends of SEK 172.7 million, tax payments of SEK 37.7 million, investments in TwoPac of SEK 13.3 million and the acquisition of shares in TwoPac of SEK 30.0 million.

Equity

Consolidated equity amounted to SEK 301.3 million (441.7). The Group's equity/assets ratio was 83% (84).

In June 2012 BioGaia carried out the warrant programme that was resolved on by the Annual General Meeting the same year. A total of 87,000 warrants were subscribed for, of which the management subscribed for 41,000. The warrants were issued at a market price of SEK 14.27 each following valuation according to the Black & Scholes formula, which provided the Parent Company with proceeds of SEK 1.3 million. Each warrant entitles the holder to subscribe for one class B share for SEK 241.90 on 1 June 2015. Volatility was estimated at 40%.

If all of the subscription warrants are exercised, the company's equity will be increased by SEK 21.0 million. This represents a dilutive effect of approximately 0.5% on the share capital and 0.4% on the total number of votes upon the full exercise of warrants.

In order to achieve a high level of participation, the AGM decided to pay a subsidy of SEK 10 per warrant (after 1 June 2015) to the employees who have subscribed for subscription warrants but have not exercised the right to buy shares. No provisions for this obligation have yet been made, since the assessment is that with the applicable market price, all holders should exercise the right to buy shares. However, the need will be continuously evaluated.

Investments in property, plant and equipment

Investments in property, plant and equipment during the period amounted to SEK 9.5 million (23,5), of which SEK 7.5 million (21.7) refers to TwoPac AB.

Subsidiary in Japan

Net sales in the Japanese subsidiary during the period amounted to SEK 7.9 million (10.4). Operating profit in the Japanese subsidiary was SEK -4.9 million (-4.7). The drop in sales to the distributor is due to lower inventory in connection with rationalisations in distribution and discontinued sales by a drug store chain. The company is taking steps to replace this customer.

Subsidiary TwoPac AB

TwoPac AB was owned 50% by BioGaia and 50% by TwoPac's management. Since 1 January 2011, TwoPac is consolidated in the BioGaia Group. On 1 July 2013 BioGaia acquired the remaining 50% of TwoPac (see below).

Net sales in TwoPac amounted to SEK 27.1 million (20.6). Operating profit was SEK 7.8 million (6.3). Profit after tax was SEK 5.7 million (4.3).

Subsidiary CapAble AB

CapAble, which is owned 90.1% by BioGaia AB and 9.9% by the company's president, was started in 2008 to manufacture and sell the patented LifeTop Cap.

Net sales in CapAble during the period totalled SEK 0.1 million (0.1). Operating profit was SEK -2.1 million (-1.9). The reason for the lack of sales during the first six months is that the machinery that manufactures LifeTop Cap has been rebuilt to improve the quality of the product. A first trial delivery took place at the beginning of the third quarter and the company's assessment is that the goals for improvement of the product have been met. This means that additional deliveries will be made in the fourth quarter.

Parent Company

Net sales in the Parent Company reached SEK 221.0 million (564.7) and profit before tax and appropriations was SEK 54.8 million (426.1).

Since it is uncertain whether the receivable from BioGaia Japan will be recovered in the foreseeable future, a provision has been made for the amount in question. This has resulted in an impairment loss of SEK 9.2 million (5.3), which has had a negative impact on profit.

Profit after tax was SEK 42.5 million (313.0). Cash flow in the Parent Company totalled SEK -133.5 million (235.6).

FINANCIAL PERFORMANCE IN THE THIRD QUARTER OF 2013

Third quarter sales

Sales for the third quarter amounted to SEK 62.2 million (62.8), down by SEK 0.6 million (1%) compared to the same period of last year. No material foreign exchange effects on sales arose during the quarter compared to the same period of last year.

Compared to the previous quarter, sales fell by SEK 23.1 million, which is mainly due to lower activity among distributors and suppliers in connection with the customary summer holiday in Europe.

Sales of finished consumer products amounted to SEK 46.4 million (50.2), a decrease of SEK 3.8 million (8%) compared to the same period of last year. Sales rose in the USA and Canada and "Rest of world", but declined above all in Europe but also in Asia. The increase in the USA is due to sales to the new distributor of drops in the USA, Gerber. In Europe, sales grew in Finland, Ukraine, Sweden, Turkey and France but fell in Italy and a few Eastern European countries, primarily Poland. The decrease in Italy is due to reduction of inventory at the distributor and also to the ongoing difficult economic situation in the country. In Poland, sales are down as an effect of aggressive price competition.

Sales of component products reached SEK 15.7 million (12.5), an increase of SEK 3.2 million (26%) compared to the same period of last year. This is mainly explained by the fact that revenue from the new agreement with Nestlé (see below) was recognised during the quarter.

Gross profit for the third quarter

Gross profit amounted to SEK 43.2 million (43.3), a decrease of SEK 0.1 million (0%) compared to the same period of last year. Gross margin was unchanged (69%) compared to the year-earlier period. The gross margin for finished consumer products fell from 71% to 68% as a result of the product mix. During the quarter, BioGaia's partner in Japan, Nippon Access, launched yoghurt products with a lower margin than for other finished consumer products. For component products, gross margin rose from 60% to 73%, mainly due to revenue under the new agreement with Nestlé (see below).

Other operating expenses in the third quarter

In general, other operating expenses are lower in the third quarter than in other quarters of the year due to the customary summer holiday.

Selling expenses for the third quarter decreased from SEK 17.4 million compared to the same period of last year to SEK 17.3 million (1%). This is explained by lower expenses for marketing activities during the period. Compared to the second quarter of 2013, selling expenses were down by SEK 2.7 million.

Administrative expenses fell by SEK 0.1 million (3%) compared to the same period of last year and amounted to SEK 2.8 million. Compared to the previous quarter, administrative expenses decreased by SEK 1.5 million.

R&D expenses for the third quarter amounted to SEK 9.0 million (7.0), which is an increase of SEK 2.0 million (29%) compared to the same period of last year. The increase is due to higher costs for clinical studies. Compared to the second quarter, R&D expenses declined by SEK 2.6 million.

Operating profit for the third quarter

Operating profit for the third quarter was SEK 13.8 million (13.5), which is an increase of SEK 0.3 million (2%) compared to the same period of last year. Excluding foreign exchange effects, operating profit decreased by 3%.

Profit before tax for the third quarter

Profit before tax was SEK 16.5 million (20.1), which is a decrease of SEK 3.6 million (18%) compared to the same period of last year. Net financial items include a foreign exchange gain of SEK 1.7 million (4.3) on forward exchange contracts in EUR (for more information see above).

Profit after tax for the third quarter

Profit after tax was SEK 13.4 million (14.2), which SEK 0.8 million (6%) lower than in the same period of last year.

Cash flow for the third quarter

Cash flow was SEK -6.2 million (-9.9). This figure includes SEK 30.0 million referring to the acquisition of the remaining 50% of TwoPac.

KEY EVENTS IN THE THIRD QUARTER OF 2013

Launches in the third quarter of 2013

Distributor/licensee Product Country
Cube Pharmaceutical Digestive health tablets Greece
Nippon Access Yoghurt with L. reuteri
Prodentis
Japan
Nestlé Infant formula with
Lactobacillus reuteri
Protectis
Denmark, Sweden,
Central and Western
Africa region, Syria,
Yemen and Iraq
Noos/Italchimichi Digestive health tablets
with Vitamin D
Italy
Sunstar Oral health tablets and
oral health drops
Relaunch in Germany

BioGaia acquires remaining 50% of TwoPac AB

TwoPac AB was formed in 2002 to manufacture and develop packaging solutions for probiotics. At present the company primarily produces probiotic drops, but also manufactures straws on behalf of BioGaia. The company's revenue consists entirely of sales to BioGaia. In 2012 the company completed a new factory in Eslöv, Sweden, that was financed mainly with loans from BioGaia. TwoPac is consolidated in the Group since 1 January 2011.

BioGaia has previously owned 50% of TwoPac AB and the remaining shares have been held by TwoPac's management. In June BioGaia signed an agreement to acquire the remaining 50% of the company.

BioGaia acquired the remaining 50% of TwoPac AB on 1 July 2013 for SEK 30 million. A controlling influence was acquired already on 1 January 2011, although no shares were purchased at the time since the assessment was that BioGaia had a controlling influence as of that date. As a result, only cash and cash equivalents and total equity were affected by the acquisition of the remaining 50% as of 1 July, 2013.

TwoPac AB has thus become a wholly owned subsidiary of BioGaia AB. The motives for the acquisition are to gain full control over part of the company's product manufacturing, but above all to join forces with TwoPac in effective development of new products that can be manufactured at a reasonable cost.

Per Hjalmarsson, a former shareholder and the President of TwoPac, has continued to lead the company's operations.

FDA approves BioGaia's request for orphan drug designation

Necrotising enterocolitis (NEC) is a rare and extremely severe disease that affects premature infants. BioGaia is in a very early stage of investigating the possibilities of developing a drug in this field and has submitted a request for orphan drug designation in the USA. The FDA's (Food and Drug Administration) Office of Orphan Product Development approved BioGaia's request at the beginning of August.

Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases or disorders affecting less than 200,000 patients per year in the USA. An orphan drug designation qualifies the company applying for it to receive certain benefits from the US government, such as tax reductions and marketing incentives, in exchange for developing the drug.

The approval does not change the standard regulatory requirements and processes for obtaining marketing approval for a product. Consequently, all aspects of the development must be investigated, including the clinical safety and efficacy documentation required for a market authorisation.

As pharmaceuticals are not part of BioGaia's current business activities, the company is exploring how a possible development process should continue in order to avoid deflecting attention from the core business. For this purpose, all business related to this field is handled by the subsidiary Infant Bacterial Therapeutics AB.

New study shows that Lactobacillus reuteri Prodentis improves treatment of patients with periodontal disease

A double-blind, placebo-controlled study of patients with chronic periodontitis showed that treatment with Lactobacillus reuteri Prodentis as an adjunct to standard treatment significantly improved efficacy by 53%. The study was published in mid-August in Journal of Clinical Periodontology.

KEY EVENTS AFTER THE END OF THE THIRD QUARTER

Lactobacillus reuteri Protectis only probiotic effective in treating colic

According to a recently published review and meta-analysis on prevention and treatment of colic, BioGaia's probiotic strain L. reuteri Protectis is the only probiotic shown to significantly reduce crying time in breast-fed infants diagnosed with colic. The study was published online on 7 October 2013 in the journal JAMA Pediatrics.

KEY EVENTS EARLIER IN 2013

Launches in the first half of 2013

Distributor/licensee Product Country
BG Distribution Digestive health tablets with
strawberry flavour
Hungary
Ewopharma Digestive health tablets with
Vitamin D
Bulgaria
Ferozsons
Laboratorium
Drops and Digestive health
tablets with lemon flavour
Pakistan
Gerber Products
Company
Drops USA
Laboratoire PediAct Digestive health tablets with
strawberry flavour
France
Nestlé Infant formula with Lactobacillus
reuteri Protectis
Colombia, Israel
and Thailand
Nestlé Mexico Drops Mexico
Pharmaforte Oral health tablets and
oral health drops
Singapore
Verman Digestive health tablets with
Vitamin D
Finland

Agreement for drops and tablets in South Korea

At the beginning of May BioGaia signed an agreement with Dong Sung Pharmaceutical Company Ltd for the exclusive rights to sell BioGaia's ProTectis drops and ProTectis and Gastrus digestive health tablets through the retail pharmacy channel in South Korea starting in 2013. The products will be sold under BioGaia's own brand.

Agreement for drops and tablets in China

In mid-May BioGaia signed an agreement with Beijing Keyuan Xinhai Pharmaceutical Co Ltd for the exclusive rights to sell BioGaia ProTectis drops and ProTectis and Gastrus digestive health tablets through the retail pharmacy channel in China starting in 2013. The products will be sold under BioGaia's own brand.

Agreement with Nestlé for new category of products

At the end of May BioGaia signed a new supply and license agreement with Nestlé for the inclusion of BioGaia's patented Lactobacillus reuteri in a new category of products. The long-term agreement gives Nestlé exclusive rights to utilise this probiotic in an additional range of products in a large number of countries, with a focus on emerging markets.

This is the third agreement with Nestlé following the sale of the license to use Lactobacillus reuteri in infant nutrition to Nestlé in February 2012. The new agreement illustrates the excellent collaboration between the two companies, with cooperation in both the scientific and commercial fields.

EMPLOYEES

The number of employees in the Group (including TwoPac AB) at 30 September 2013 was 85 (74).

Incentive scheme for the employees

In June 2012 BioGaia carried out the subscription warrant programme for all employees in the BioGaia Group that was resolved on by the AGM the same year. For more information, see above under "Equity".

SIGNIFICANT RISKS AND UNCERTAINTIES; GROUP AND PARENT COMPANY

The Japanese subsidiary has operated at a loss since the start in 2006. The business model previously used was found to be unsuccessful and in 2010 a decision was made to change the business model in Japan to that which is used in the other markets. On the balance sheet date, assets in the Japanese subsidiary were reported at SEK 9.1 million in the Group. BioGaia's assessment is that there is no indication of impairment of these assets. In the Parent Company, all receivables and participations in the Japanese subsidiary have been written down to zero.

CapAble, which is 90.1% owned by BioGaia AB, was started in November 2008 to manufacture and sell the patented LifeTop Cap. The shares in the subsidiary CapAble amount to a total of SEK 6.9 million in the Parent Company. CapAble has operated at a loss since the start in 2008. BioGaia made total conditional shareholder contributions of SEK 6 million to CapAble in 2009 and 2010. BioGaia AB has made total group contributions of SEK 7.3 million during the period from 2010 to 2012. Profit before tax for January-September amounted to SEK -2.1 million (-2.0). On the balance sheet date, assets in CapAble were reported at SEK 5.4 million in the Group. BioGaia's assessment is that CapAble will show profitability in coming years, for which reason there was no indication of impairment on the balance sheet date.

In February 2012 BioGaia signed several new agreements with Nestlé including the acquisition of a perpetual license to use BioGaia's probiotic in infant formula during the remaining term of the patent. The purchase price was EUR 50.8 million, of which EUR 40.0 million (SEK 356 million) was received and recognised as revenue in 2012 according to generally accepted accounting practices. The additional payments of EUR 10.8 million will be received during the period 2014-2017 on the achievement of predefined milestones. The company assesses the probability of achieving these milestones as high, but feels that the degree of uncertainty is still too large to recognise this revenue in accordance with generally accepted accounting practices.

For further information, see the administration report and Notes 28 and 29 of the annual report for 2012.

ACCOUNTING POLICIES

The consolidated financial statements are presented in compliance with the International Financial Reporting Standards (IFRS) issued by the International Accounting Standards Board (IASB) and the interpretations published by the IFRS 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 Parent Company have applied the same accounting and valuation standards as in the latest annual report.

New accounting standards

The applied accounting policies correspond to those described in the annual report for 2012, aside from a number of minor amendments to existing standards and new interpretations that are effective as of 1 January 2013. These are not assessed to have any significant impact on the Group's or the Parent Company's profit, financial position or disclosures.

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 a sustainable operating margin (operating profit in relation to sales) of at least 30% with continued strong growth and increased investments in research, product development and brand building.

BioGaia's dividend policy is to pay a shareholder dividend equal to 40% of profit after tax.

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 a growing distribution network covering a large share of the key markets, BioGaia's future outlook is bright.

Statements of comprehensive income - Group
(Amounts in SEK 000s) Jan-Sept Jan-Sept July-Sept July-Sept Jan-Dec Oct 2012- Oct 2011-
2013 2012 2013 2012 2012 Sept 2013 Sept 2012
Net sales 225,654 216,845 62,169 62,814 289,248 298,057 299,241
License revenue - 356,004 - - 356,004 - 356,004
Cost of goods sold -70,600 -63,871 -18,959 -19,500 -88,179 -94,908 -89,031
Gross profit 155,054 508,978 43,210 43,314 557,073 203,149 566,214
Selling expenses -56,628 -55,895 -17,257 -17,423 -77,361 -78,094 -74,183
Administrative expenses -10,615 -9,736 -2,768 -2,901 -13,423 -14,302 -13,901
Research and development expenses -30,856 -25,227 -8,995 -6,959 -35,788 -41,417 -35,100
Other operating income 925 - - - - 1 683 -
Other operating expenses - -3,189 -394 -2,575 -2,431 - -4,341
Operating profit 57,880 414,931 13,796 13,456 428,070 71,019 438,689
Interest income 3,916 6,519 1,026 2,429 8,569 5,966 7,640
Foreign exchange gain, forward contracts 129 7,288 1,674 4,267 5,676 -1,483 12,059
Financial expenses -75 -48 -13 -9 -73 -100 -70
Profit before tax 61,850 428,690 16,483 20,143 442,242 75,402 458,318
Tax -13,956 -114,626 -3,123 -5,985 -112,371 -11,701 -122,495
PROFIT FOR THE PERIOD 47,894 314,064 13,360 14,158 329,871 63,701 335,823
Items that will be reclassified to profit or loss
Gains/losses arising on translation of the financial ,
statements of foreign operations -722 -372 -164 -532 -1,059 -1,941 -340
Comprehensive income for the period 47,172 313,692 13,196 13,626 328,812 61,760 335,483
Profit for the period attributable to:
Owners of the Parent Company 45,422 312,115 13,428 13,849 326,970
Non-controlling interests 2,472 1,949 -68 309 2,901
47,894 314,064 13,360 14,158 329,871
Comprehensive income for the period attributable to:
Owners of the Parent Company 44,700 311,743 13,264 13,317 325,911
Non-controlling interests 2,472 1,949 -68 309 2,901
47,172 313,692 13,196 13,626 328,812
Earnings per share
Basic earnings per share (average number of shares), SEK 2.63 18.07 0.78 0.80 18.93
Diluted earnings per share, SEK 2.63 18.07 0.78 0.80 18.93
Number of shares, thousands 17,271 17,271 17,271 17,271 17,271
Average number of shares, thousands 17,271 17,271 17,271 17,271 17,271
Number of outstanding warrants, thousands
Number of outstanding warrants with a dilutive effect,
thousands
87
-
87
-
87
-
87
-
87
-
Number of shares after dilution, thousands 17,271 17,271 17,271 17,271 17,271
CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION 30 Sept 31 Dec 30 Sept
(Amounts in SEK 000s) 2013 2012 2012
ASSETS
Intangible assets 54,880 49,193 43,874
Other non-current receivables 17 17 17
Total non-current assets 54,897 49,210 43,891
Current assets excl. cash and cash equivalents 66,848 92,838 78,038
Cash and cash equivalents 243,193 374,974 404,065
Total current assets 310,041 467,812 482,103
TOTAL ASSETS 364,938 517,022 525,994
EQUITY AND LIABILITIES
Equity attributable to owners of the Parent Company 301,739 453,303 439,156
Non-controlling interests -483 3,491 2,539
Total equity 301,256 456,794 441,695
Provision for deferred tax 24,649 24,710 185
Interest-free current liabilities 39,033 35,518 84,114
TOTAL EQUITY AND LIABILITIES 364,938 517,022 525,994
Pledged assets 2,000 2,000 2,000
CONSOLIDATED CASH FLOW STATEMENTS Jan-Sept Jan-Sept July-Sept July-Sept Jan-Dec
(Amounts in SEK 000s) 2013 2012 2013 2012 2012
Operating activities
Operating profit 57,880 414,931 13,796 13,456 428,070
Depreciation/amortisation 3,788 4,024 1,277 1,383 4,545
Other non-cash items -17 623 117 547 346
61,651 419,578 15,190 15,386 432,961
Gains/losses on realised forward exchange contracts 439 1,965 -8 1,298 2,818
Paid tax -5,488 -73,515 -4,343 -32,221 -105,736
Interest received and paid 3,843 6,471 1,015 2,420 8,496
Cash flow from operating activities before changes
in working capital 60,445 354,499 11,854 -13,117 338,539
Changes in working capital 20,041 4,578 16,300 8,805 -2,982
Cash flow from operating activities 80,486 359,077 28,154 -4,312 335,557
Cash flow from investing activities -39,514 -23,475 -34,348 -5,670 -29,391
Cash flow from financing activities -172,710 -102,352 0 97 -102,373
Cash flow for the period -131,738 233,250 -6,194 -9,885 203,793
Cash and cash equivalents at beginning of period 374,974 171,534 249,560 414,499 171,534
Exchange difference in cash and cash equivalents -43 -719 -173 -549 -353
Cash and cash equivalents at end of period 243,193 404,065 243,193 404,065 374,974

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(Amounts in SEK 000s) Jan-Sept Jan-Sept Jan-Dec
2013 2012 2012
At beginning of period 456,794 230,355 230,355
Dividends -172,710 -103,626 -103,626
Subscription warrants - 1,274 1,253
Acquisition of TwoPac -30,000 - -
Comprehensive income for the period 47,172 313,692 328,812
At end of period 301,256 441,695 456,794

REPORTING BY SEGMENT – GROUP

(Amounts in SEK 000s)

Revenue by segment Jan-Sept Jan-Sept July-Sept July-Sept Jan-Dec Oct 2012- Oct 2011-
2013 2012 2013 2012 2012 Sept 2013 Sept 2012
Finished consumer products 181,056 172,002 46,446 50,181 237,583 246,637 229,477
Component products 43,559 43,803 15,652 12,461 50,577 50,333 68,348
License revenue (component products) 1) - 356,004 - - 356,004 - 356,004
Other products 1,039 1,040 71 172 1,088 1,087 1,416
225,654 572,849 62,169 62,814 645,252 298,057 655,245
Jan-Sept Jan-Sept July-Sept July-Sept Jan-Dec Oct 2012- Oct 2011-
Gross profit by segment 2013 2012 2013 2012 2012 Sept 2013 Sept 2012
Finished consumer products 129,126 123,476 31,742 35,621 170,275 175,925 166,401
License revenue (component products) 1) - 356,004 - - 356,004 - 356,004
Other products 612 855 70 153 859 617 1,201
155,054 508,978 43,210 43,314 557,073 203,150 566,214

Component products 25,316 28,643 11,398 7,540 29,935 26,608 42,608

1) License revenue refers to revenue from Nestlé (see above in text). The license revenue is included in component products but is reported on a separate line in order to achieve better comparability between years.

Revenue by geographical market

Jan-Sept Jan-Sept July-Sept July-Sept Jan-Dec Oct 2012- Oct 2011-
Net sales 2013 2012 2013 2012 2012 Sept 2013 Sept 2012
Europe 162,260 151,568 41,851 44,411 203,328 214,020 212,296
License revenue (Europe) 2) - 356,004 - - 356,004 - 356,004
USA and Canada 13,572 20,675 5,089 3,967 28,422 21,319 29,203
Asia 26,107 26,167 6,695 7,787 32,420 32,360 33,758
Rest of world 23,715 18,435 8,534 6,649 25,078 30,358 23,984
225,654 572,849 62,169 62,814 645,252 298,057 655,245

2) License revenue refers to revenue from Nestlé (see above in text). The license revenue is included in Europe but is reported on a separate line in order to achieve better comparability between years.

PARENT COMPANY INCOME STATEMENTS Jan-Sept Jan-Sept Jan-Dec
(Amounts in SEK 000s) 2013 2012 2012
Net sales 220,966 208,741 278,515
License revenue - 356,004 356,004
Cost of goods sold -79,188 -69,754 -97,475
Gross profit 141,778 494,991 537,044
Selling expenses -43,328 -41,627 -57,673
Administrative expenses -9,970 -9,055 -12,248
Research and development expenses -31,000 -25,200 -35,868
Other operating income 925 - -
Other operating expenses - -3,189 -2,430
Operating profit 58,405 415,920 428,825
Impairment loss on receivable from subsidiary -9,175 -5,348 -8,574
Impairment loss on shares in subsidiary - - -2,583
Net financial items 5,612 15,534 17,220
Profit before appropriations and tax 54,842 426,106 434,888
Provisions to tax allocation reserve - - -109,341
Profit before tax 54,842 426,106 325,547
Tax expense -12,319 -113,083 -86,270
PROFIT FOR THE PERIOD 42,523 313,023 239,277
PARENT COMPANY BALANCE SHEETS 30 Sept 31 Dec 30 Sept
2013 2012 2012
ASSETS
Intangible assets - - -
Property, plant and equipment 2,486 2,275 2,505
Shares in group companies 51,160 21,160 21,160
Non-current receivables from subsidiaries 24,513 24,513 24,513
Total non-current assets 78,159 47,948 48,178
Current assets excl. cash and cash equivalents 57,840 85,009 71,170
Cash and cash equivalents 237,954 371,448 396,792
Total current assets 295,794 456,457 467,962
TOTAL ASSETS 373,953 504,405 516,140
EQUITY AND LIABILITIES
Equity 219,473 349,660 423,427
Tax allocation reserve 109,341 109,341 -
Interest-free current liabilities 45,139 45,404 92,713
TOTAL EQUITY AND LIABILITIES 373,953 504,405 516,140
Pledged assets 2,000 2,000 2,000
PARENT COMPANY CASH FLOW STATEMENTS Jan-Sept Jan-Sept Jan-Dec
2013 2012 2012
Operating activities
Operating profit 58,405 415,920 428,825
Depreciation/amortisation 884 1,177 1,510
Other non-cash items -17 623 308
Gain/losses on realised foreign exchange contracts 439 1,965 2,818
Paid tax -5,473 -73,482 -105,690
Interest received and paid 4,293 6,939 9,120
Cash flow from operating activities before changes in working capital 58,531 353,142 336,891
Changes in working capital 16,518 -4,218 -13,512
Cash flow from operating activities 75,049 348,924 323,379
Cash flow from investing activities -35,850 -10,999 -11,123
Cash flow from financing activities -172,710 -102,352 -102,373
Cash flow for the period -133,511 235,573 209,883
Cash and cash equivalents at beginning of period 371,448 161,865 161,865
Exchange difference in cash and cash equivalents 17 -646 -300
Cash and cash equivalents at end of period 237,954 396,792 371,448

PARENT COMPANY STATEMENTS OF CHANGES IN EQUITY

(Amounts in SEK 000s) Jan-Sept Jan-Sept Jan-Dec
2013 2012 2012
At beginning of year 349,660 212,756 212,756
Dividends -172,710 -103,626 -103,626
Subscription warrant programme - 1,274 1,253
Profit for the period 42,523 313,023 239,277
At end of period 219,473 423,427 349,660

RELATED PARTY TRANSACTIONS – PARENT COMPANY

(Amounts in SEK 000s)

The Parent Company holds 100% of the shares in BioGaia Biologics Inc, USA , BioGaia Japan Inc, Infant Baby Therapeutic AB and Tripac AB. Since 1 July 2013, the Parent Company holds 50% of the shares in TwoPac AB (previously 50%). The Parent Company holds 90.1 % of the shares in CapAble AB.

Annwall & Rothschild Investment AB holds 740,668 class A shares and 1,259,332 class B shares, which is equal to 11.6% of the share capital and 36.2% of the votes. Annwall & Rothschild Investment AB is owned by Peter Rothschild, President of BioGaia, and Jan Annwall, a member of the Board of the Parent Company. The only transaction that took place during 2013 is the payment of a dividend of SEK 10 per share. No other transactions between BioGaia and Annwall & Rothschild Investment AB took place during the period.

The following transactions have taken place with BioGaia Japan Jan-Sept Jan-Sept Jan-Dec
2013 2012 2012
Interest income 1,168 1,278 2,386
Loan provided -4,575 -1,670 -1,670
Sale of goods 3,252 2,400 4,518

Due to uncertainty about whether the receivable from BioGaia Japan will be recovered in the foreseeable future, a provision has been made for this amount.

The following transactions have taken place with TwoPac AB (incl. subsidiary)

Jan-Sept Jan-Sept Jan-Dec
2013 2012 2012
Interest income 451 479 643
Loan provided - -8,000 -8,000
Purchase of goods -27,088 -20,579 -29,314

No significant transactions have taken place with other closely related companies.

The closing balance at the end of the period was as follows:

30 Sept 30 Sept 31 Dec
2013 2012 2012
Non-current receivables from TwoPac AB (incl. subsidiary) 23,491 23,491 23,491
Current transactions with related parties
Current receivables from TwoPac AB 219 169 164
Current liabilities to TwoPac AB -4,915 -3,603 -1,972
-4,696 -3,434 -1,808
CONSOLIDATED KEY RATIOS 1
)
Jan-Sept Jan-Sept Jan-Sept
2012
excl. non
2013 2012 recurring
revenue2
)
Net sales, SEK 000s 225,654 572,849 216,845
Operating profit, SEK 000s 57,880 414,931 58,927
Profit after tax, SEK 000s 47,894 314,064 51,689
Return on
- average equity 12% 93% 24%
- average capital employed 16% 128% 35%
Capital employed, SEK 000s 325,905 441,880 179,505
Number of shares, thousands 17,271 17,271 17,271
Average number of shares, thousands 17,271 17,271 17,271
Number of outstanding warrants, thousands 87 87 87
Average number of outstanding warrants with a
dilutive effect, thousands
- - -
Number of shares after dilution, thousands 17 271 17 271 17 271
Basic earnings per share, SEK 2.63 18.07 2.88
Diluted earnings per share, SEK 2.63 18.07 2.88
Basic equity per share, SEK 17.47 25.43 10.24
Diluted equity per share, SEK 17.47 25.43 10.24
Equity/assets ratio 83% 84% 85%
Operating margin 26% 72% 27%
Profit margin 27% 75% 34%
Average number of employees 81 69 69

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

2) Excluding licence revenue from Nestlé (see above under "Financial performance during the period from January to September 2013)

CALENDAR

12 February 2014 Year-end report 2013
6 May 2014 Interim report 1 January – 31 mars, 2014
6 May 2014 Annual General Meeting at 4:00 p.m in Stockholm. Shareholders who wish to have a matter dealt with at the AGM
must submit a request by 20 March 2014 to the Board Chairman, BioGaia AB, Box 3242, SE-103 64
STOCKHOLM, Sweden, or by e-mail to [email protected].
20 August 2014 Interim report 1 January – 30 June 2014
22 October 2014 Interim report 1 January – 30 September 2014

This interim report provides a true and fair picture of the business activities, financial position and results of operations of the Parent Company and the Group, and describes the significant risks and uncertainties to which the Parent Company and the Group companies are exposed.

Stockholm, 23 October 2013

David Dangoor Jan Annwall Stefan Elving Board Chairman Board member Board member

Thomas Flinck Inger Holmström Jörgen Thorball Board member Board member Board member

This interim report has not been examined by the company's independent auditor.

Paula Zeilon Peter Rothschild Board member President

BioGaia AB

The company

BioGaia is a healthcare 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) in combination with unique packaging solutions that make it possible to create probiotic products with a long shelf life.

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

BioGaia has 85 employees, of whom 31 are based in Stockholm, 23 in Lund, 22 in Eslöv, two in Raleigh, USA, six in Hiroshima, Japan, and one in Shanghai, China.

Business model

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

The products are sold through nutrition, food, natural health and pharmaceutical companies in some 80 countries worldwide. BioGaia holds patents for the use of Lactobacillus reuteri and certain packaging solutions in all major markets.

The BioGaia brand

At the beginning of 2006 BioGaia launched its own consumer brand and today there are a number of distribution partners that sell finished products under the BioGaia brand in a large number of markets. One central part of BioGaia's strategy is to increase the share of sales consisting of BioGaia-branded products.

Some of BioGaia's distributors sell finished consumer 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.

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

Research and clinical studies

BioGaia´s strains of Lactobacillus reuteri are some of the world's most well researched probiotics, especially in young children. To date, 108 clinical studies using BioGaia's human strains of Lactobacillus reuteri have been performed on around 8,600 individuals of all ages. The results have been published in 72 articles in scientific journals.

Studies have been performed on:

  • Infantile colic and digestive health in children
  • Antibiotic-associated diarrhoea (AAD)
  • Acute diarrhoea
  • Gingivitis (inflammation of the gums)
  • Periodontal disease
  • General health
  • Helicobacter pylori (the gastric ulcer bacterium)
  • Necrotising enterocolitis (NEC)

REPORTING OF CLINICAL STUDIES

Publication of clinical trial results is a key success factor for BioGaia. The International Committee of Medical Journal Editors has initiated a policy requiring clinical investigators to deposit information about trial design into an accepted clinical trials registry before the onset of patient enrolment, and this has now become a prerequisite for publication of trial outcomes in major medical journals. ClinicalTrials.gov is a registry of clinical trials provided by the U.S. National Institutes of Health and BioGaia encourages all clinicians working with BioGaia products to register their trials on this site. Many of the trials are registered at an early stage, which means that some of the registered trials will not be performed as planned. Consequently, BioGaia takes no responsibility for ensuring that the registered trials reach completion or are successfully reported in the register or the scientific literature. When clinical trial results of significance for the company's operations do become available, BioGaia will report these through press releases.

Latest press releases from BioGaia:

2013-10-10 Meta-analysis: Lactobacillus reuteri Protectis only probiotic effective in treating colic
2013-08-22 BioGaia AB Interim report 1 January – 30 June 2013
2013-08-16 New study shows: Lactobacillus reuteri Prodentis improves periodontal treatment

BioGaia AB Box 3242, SE-103 64 STOCKHOLM Street address: Kungsbroplan 3A, Stockholm Telephone: +46 8-555 293 00, corp. identity no. 556380-8723 www.biogaia.com For additional information contact: Peter Rothschild, President, BioGaia AB, telephone +46 8-555 293 20 Margareta Hagman, Executive Vice President, BioGaia AB, telephone +46 8-555 293 04

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