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BioGaia

Quarterly Report Oct 25, 2016

3013_10-q_2016-10-25_92afb146-eff0-4a0d-b3ca-81f8adba0185.pdf

Quarterly Report

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Press Release, 25 October 2016

BioGaia AB Interim management statement 1 January – 30 September 2016

(Figures in brackets refer to the same period of last year. The comparative figures in the balance sheet refer to 31 December 2015)

Comments from the Managing Director:

"Third quarter sales were driven by strong growth in Asia and Europe, where the launch of EasyDropper is continuing. Net sales for the first nine months reached SEK 395.9 million. It is highly gratifying that we have now passed the level for 2015, in spite of the major inventory build-up in Brazil last year. Promising is also the trend in Business Unit Adult Health, which has shown growth for two consecutive quarters. I would also like to mention that the clinical study on reduction of pregnancy gingivitis, which we have previously reported on, has been very well received by our partners, and it is very satisfying that we have signed a sales agreement in Western and Eastern Africa", says Axel Sjöblad, Managing Director of BioGaia AB.

Period from 1 January – 30 September 2016

Net sales amounted to SEK 395.9 million (378.9), an increase of SEK 17.0 million (4%). (No material foreign exchange effects arose.)

Net sales in Business Unit Paediatrics reached SEK 313.8 million (313.0), an increase of SEK 0.8 million (0 %). (No material foreign exchange effects arose.)

Net sales in Business Unit Adult Health amounted to SEK 69.4 million (54.6), an increase of SEK 14.8 million (27%) (excluding foreign exchange effects, 24%).

Operating profit excluding the distributed former subsidiary IBT was SEK 153.1 million (140.8), an increase of SEK 12.3 million (9%). Including IBT, operating profit was SEK 147.9 million (124.7). (No material foreign exchange effects arose.)

Profit after tax excluding IBT was SEK 112.4 million (112.2), an increase of SEK 0.2 million (0%).

Earnings per share from continuing operations totalled SEK 6.48 (6.49). Earnings per share including discontinued operations totalled SEK 10.42 (5.76).

The period's cash flow was SEK -27.6 million (8.0). Cash and cash equivalents at 30 September 2016 amounted to SEK 201.6 million (226.9). Cash flow includes the distribution of the subsidiary IBT, which had a negative impact on cash flow of SEK 37.6 million.

Third quarter 2016

Net sales amounted to SEK 126.0 million (106.0), an increase of SEK 20.0 million (19%) (excluding foreign exchange effects, 17%).

Net sales in Business Unit Paediatrics reached SEK 99.0 million (88,9), an increase of SEK 10.1 million (11%) (no material foreign exchange effects arose).

Net sales in Business Unit Adult Health amounted to SEK 22.6 million (12.6), an increase of SEK 10.0 million (79%) (excluding foreign exchange effects, 70%).

Operating profit excluding IBT was SEK 48.4 million (36.2), an increase of SEK 12.2 million (34 %). Including IBT, operating profit was SEK 48.4 million (29.7). (No material foreign exchange effects arose.)

Profit after tax excluding IBT was SEK 35.1 million (25.7), an increase of SEK 9.4 million (37%). Including IBT, profit after tax was SEK 35.1 million (20.7).

Earnings per share excluding IBT totalled SEK 2.02 (1.49). Earnings per share including IBT totalled SEK 2.02 (1.19).

Key events in the third quarter of 2016

Publication of study showing that BioGaia ProDentis reduces pregnancy gingivitis.

Agreement for the sale of drops, tablets and oral rehydration solution in Kenya, Nigeria and Ghana.

Teleconference: You are welcome to take part in a teleconference on the interim management statement that will be held today 25 October at 8:45 a.m. by Managing Director Axel Sjöblad. To participate in the teleconference call please see www.biogaia.com/agenda for telephone numbers. The teleconference can also be followed at https://wonderland.videosync.fi/biogaia-q3-report.

This information is information that BioGaia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 25 October 2016, 8:00 a.m. CET.

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

BioGaia AB (publ.)

Interim management statement 1 January – 30 September 2016

Figures in brackets refer to the same period of last year. The comparative figures in the balance sheet refer to 31 December 2015.

We hereby present BioGaia AB's interim management statement for the period from 1 January to 30 September 2016. A description of the company's operations is provided on page 11.

MANAGING DIRECTOR'S COMMENTS

In the third quarter we continued focusing on the expansion of our product portfolio among our existing partners, on the rollout of Prodentis and Gastrus and on the launch of EasyDropper (the new packaging solution for our drops with easier and more precise dosing). As earlier in the year, these efforts were supplemented with additional activities in our anticipated future growth markets, where we are currently concentrating mainly on the USA, Japan, India and the UK.

Internally our change process continues with the aim of increasing our speed of product launch, and we expect to start seeing the results of this work in 2017.

Our sales for the third quarter of 2016 reached SEK 126.0 million, an increase of SEK 20.0 million compared to the same period of last year. It is encouraging to note that the third quarter was stronger than normal in several of our markets.

Third quarter sales were driven by strong development in Europe and Asia, where sales increased by 49% and 52%, respectively. Sales in the USA and Canada were weaker than expected, which meant that cumulative sales growth in this region fell to 10%, compared to 21% after the first two quarters of the year. Against this background, it was very encouraging to meet doctors and our partners at the WCPGHAN Congress in Montreal and feel the large interest in BioGaia's products from both North and South America.

In Business Unit Paediatrics third quarter sales reached SEK 99.0 million, an increase of 11%. Sales were up mainly as an effect of increased royalties on Growing Up Milk for children over the age of one year, higher sales of Protectis digestive health tablets (in all regions except the USA and Canada) and strong sales of drops in Europe, where the launch of EasyDropper continues.

In Business Unit Adult Health, sales amounted to SEK 22.6 million, up by a full 70%. The main explanations for the increase were a continued successful rollout of Prodentis lozenges and higher sales of Protectis digestive health tablets.

R&D expenses (excluding IBT) rose and, as earlier, I am pleased that we are stepping up the rate of clinical studies since these are vital for our future growth. This was once again apparent when we noted the interest that the latest study on reduction of pregnancy gingivitis raised among our partners.

Thanks to third quarter sales, we have increased the sales by 4% after the first nine months of the year compared to the same period of 2015. And we have achieved this despite low sales in Brazil during 2016 following last year's inventory build-up. Our Brazilian partner Aché reports continued positive development in consumer sales, which meant that we once again started to receive orders from Brazil in the third quarter. Furthermore, we are seeing a continued order intake from both South Africa and Finland, which confirms that sales have now gained good momentum in these important markets which started the year weakly.

In the fourth quarter we will continue to follow developments in the Italian market. As previously announced, our distributor Italchimici has been acquired by another of our partners, Recordati, which could lead to a short-term dip in our sales.

Nestlé is buying fewer cultures for infant formula with a very low margin at the same time as royalties from Growing Up Milk for

children over the age of one year are rising. This development has a continued positive impact on our margins and profitability.

In conclusion, I would like to highlight the third quarter signing of an agreement for the sale of drops, digestive health tablets and oral rehydration solution in Kenya, Nigeria and Ghana. For us this was an important step in Western and Eastern Africa, and our aim is for this to lay the foundation for strong future sales in the region.

FINANCIAL PERFORMANCE, JANUARY - SEPTEMBER 2016

Net sales, January-September 2016

Consolidated net sales amounted to SEK 395.9 million (378.9), which is an increase of SEK 17.0 million (4%) compared to the same period of last year.

Most of the company's sales are denominated in foreign currency, primarily EUR but also USD, CHF and JPY. With unchanged exchange rates compared to the same period of last year, net sales would have been SEK 1.7 million lower. Changes in foreign exchange rates affect both income and expenses. With unchanged exchange rates, operating profit for January-September would have been SEK 0.4 million higher. Expenses arise mainly in SEK but also in JPY, EUR and USD.

For the past 12-month period, net sales were unchanged (excluding foreign exchange effects, -1%).

Sales by segment, January - September 2016

BUSINESS UNIT PAEDIATRICS

Net sales in BioGaia's core area Paediatrics amounted to SEK 313.8 million (313.0), an increase of SEK 0.8 million (0%) (no material foreign exchange effects arose).

Sales of drops declined somewhat compared to the same period of last year. Sales of drops rose sharply in Europe and modestly in the USA, Canada and Asia, but fell in Rest of the World (mainly Brazil).

Sales of digestive health tablets in Business Unit Paediatrics were down compared to the same period of last year. Tablet sales rose above all in Asia, the USA and Canada but fell slightly in Europe and sharply in Rest of the World (mainly in Brazil).

Sales of cultures for infant formula were lower than in the same period of last year.

Royalty revenue from Nestlé for the use of Lactobacillus reuteri Protectis in Growing Up Milk for children older than one year increased compared to the same period of last year.

Royalty revenue from the collaboration agreement with Nestlé (for more information, see below under other sales) in Business Unit Paediatrics amounted to SEK 7.4 million (4.7).

For the past 12-month period, sales in Business Unit Paediatrics fell by 4% (excluding foreign exchange effects, -5%).

BUSINESS UNIT ADULT HEALTH

Net sales in Business Unit Adult Health amounted to SEK 69.4 million (54.6), an increase of SEK 14.8 million (27%) (excluding foreign exchange effects, 24%). The increase was driven by higher sales of Protectis digestive health tablets, Prodentis oral health lozenges and the rollout of Gastrus digestive health tablets.

Sales of digestive health tablets rose in Europe, Asia and Rest of the World (South Africa) compared to the same period of last year. In the USA and Canada, no digestive health tablets are sold in the Adult Health segment.

Sales of oral health products were up in all markets except the USA and Canada.

Since 2015 Gastrus is sold in Japan and South Korea. During 2016 Gastrus has been launched in Italy, Spain, Singapore and the USA and the sales are increasing continuously from a low level.

For the past 12-month period, sales in Business Unit Adult Health grew by 15% (excluding foreign exchange effects, net sales rose by 12%).

OTHER SALES

Other sales amounted to SEK 12.8 million (11.3), an increase of SEK 1.5 million.

Other sales include royalty revenue of SEK 10.5 million (8.5) from the collaboration agreement that was signed with Nestlé in March 2014. The royalty revenue amounts to a total of SEK 92.0 million for the period 2014-2017 and is distributed between Business Unit Paediatrics and New Business. Under the agreement, BioGaia has undertaken to carry out clinical studies on children and develop new products in new areas. BioGaia will recognize the royalty revenue in pace with completion of the projects. As of 30 September 2016, BioGaia had recognized revenue of SEK 58.4 million of a total of SEK 92 million, of which SEK 35.2 million in Business Unit New Business and SEK 23.2 million in Business Unit Paediatrics.

SALES BY GEOGRAPHICAL MARKET JANUARY - SEPTEMBER

Sales in Europe were up by SEK 48.8 million (23%). To SEK 262.4 million. For the past 12-month period, sales increased by 16%.

Sales in the USA and Canada rose by SEK 2.5 million (10%) to SEK 26.9 million. For the past 12-month period, sales were up by 2%.

Sales in Asia grew by SEK 8.6 million (23%) to SEK 46.8 million. For the past 12-month period, sales increased by 21%.

Sales in Rest of the World were down by SEK 42.8 million (42%) to SEK 59.9 million. This is almost exclusively due to lower sales to Brazil resulting from the inventory buildup there in the previous year. For the past 12-month period, sales decreased by 46%.

THE BIOGAIA BRAND

Of total finished consumer products, (drops, digestive health tablets, oral health lozenges, oral rehydration solution, etc.), 57% (62%) were sold under the BioGaia brand, including co-branding, during the period from January to September. The decrease is mainly due to lower sales in Brazil.

Gross profit, January-September

Gross profit amounted to SEK 283.8 million (263.2), which is an increase of SEK 20.6 million (8%) compared to the same period of last year. The total gross margin rose from 69% to 72%.

Gross margin for Business Unit Paediatrics increased from 68% to 72%. This is due to higher royalty revenue for the use of cultures in Growing Up Milk for children over the age of one year (with a 100% margin) and lower sales of cultures for infant formula with a very low margin.

Gross margin for Business Unit Adult Health fell from 70% to 64%. This is partly because Gastrus has a lower margin during the launch period and partly because the margin on both digestive and oral health tablets has decreased slightly as a result of higher costs for bacteria cultures.

Operating expenses, January-September

Total operating expenses excluding discontinued operations (IBT) rose by 8% to SEK 135.6 million. For the past 12-month period, total operating expenses were up by 2%.

Selling expenses, excluding IBT, increased compared to the same period of last year by SEK 4.1 million (6%) and amounted to SEK 74.3 million (70.2), which is equal to 19% (19%) of net sales. The increase is attributable to higher costs for marketing activities such as market samples and congress costs as well as personnel costs. For the past 12-month period, selling expenses were up by 1%.

Administrative expenses amounted to SEK 15.7 million (13.5), which is equal to 4% (4%) of net sales. The increase of SEK 2.2 million (16%) is mainly explained by higher personnel costs. For the past 12-month period, the Group's administrative expenses increased by 10%.

R&D expenses excluding IBT are reported at SEK 45.7 million (41.7), which is equal to 12% (11%) of net sales. The increase of SEK 4.0 million (10%) is mainly attributable to higher personnel costs and increased costs for research projects and clinical studies, but also higher patent costs. For the past 12-month period, R&D expenses were unchanged.

Other operating income/expenses refer to foreign exchange gains/losses on operating receivables and liabilities. These amounted to SEK 5,4 million (3.0).

Operating profit, January-September

Operating profit excluding IBT was SEK 153.1 million (140.8), an increase of SEK 12.3 million (9%) and operating margin excluding IBT was 39% (37%). Including the subsidiary IBT, operating profit was SEK 153.1 million (124.7).

Share in profit of associates

Share in profit of associates refers to BioGaia's share of profit in MetaboGen AB.

Financial items and profit before tax, January-September

Profit before tax was SEK 148.7 million (142.5), an increase of SEK 6.2 million (4%). Net financial items include a foreign exchange loss of SEK 5.6 million on forward exchange contracts in EUR and USD. The figures for the previous year include a corresponding foreign exchange gain of SEK 1.6 million.

At 30 September 2016 the company had outstanding forward exchange contracts for EUR 11.3 million at an average exchange rate of SEK 9.39 and USD 1.6 million at an average exchange rate of SEK 8.39. The actual exchange gain/loss depends on the exchange rate on the maturity date of the contracts.

Profit after tax, January-September

Profit after tax excluding IBT was SEK 112.4 million (112.2), an increase of SEK 0.2 million (0%).

The tax rate for the Group was 24% (21%). The Group pays tax on profits in the Swedish companies. The loss in Japan is not deductible against the Swedish profits. Tax loss carryforwards in the Japanese subsidiary amounted to approximately SEK 32 million at 30 September 2016. The deferred tax asset for these has not yet been recognized, since a sustainable profit level has not yet been shown in the Japanese subsidiary. That explains the higher tax rate in the Group.

Earnings per share, January-September

Earnings per share excluding IBT amounted to SEK 6.48 (6.49). Earnings per share including discontinued operations amounted to SEK 10.42 (5.76). No dilutive effects arose during the period.

Cash flow, January-September

Cash flow for the period amounted to SEK -27.6 million (8.0). BioGaia's former subsidiary IBT was distributed to BioGaia's shareholders on 29 March 2016. At that time, IBT's cash and cash equivalents amounted to SEK 37.6 million, compared to SEK 44.4 million at year-end 2015. Excluding IBT, cash flow for the period was SEK 16.8 million. Cash flow includes dividends of SEK 86.7 million (86.3). In addition, working capital increased by SEK 13.7 million during the period, compared to a decrease of SEK 8.8 million in the same period of last year. It is mainly trade receivables that have increased since year-end. Cash and cash equivalents at 30 September 2016 amounted to SEK 201.6 million (226.9).

Equity

Consolidated equity at 30 September 2016 amounted to SEK 369.4 million (395.8). The Group's equity/assets ratio was 82% (83%).

Investments in property, plant and equipment, January-September

Investments in property, plant and equipment amounted to SEK 3.5 million (15.4), of which SEK 3.3 million (15.3) refers to the subsidiary TwoPac.

Investments in capitalized development expenditure amounted to SEK 0.0 million (9.0). Investments during 2015 referred to development of a product for the NEC project in the former subsidiary IBT, which was distributed to the shareholders in March 2016.

Subsidiary in Japan, January-September

Net sales in the wholly owned subsidiary in Japan reached SEK 17.4 million (16.7). Operating profit/loss in the Japanese subsidiary was SEK -2.4 million (-1.4).

Subsidiary TwoPac AB, January-September

TwoPac AB is a wholly owned subsidiary of BioGaia that manufactures and develops products, such as drops, exclusively for BioGaia.

Net sales in TwoPac totalled SEK 53.1 million (36.1). Operating profit was SEK 14.1 million (6.0). Profit after tax was SEK 10.6 million (4.2).

Subsidiary CapAble AB, January-September

CapAble, which is owned 90.1% by BioGaia and 9.9% by CapAble's President, was started in November 2008 to manufacture and sell the patented LifeTop Cap. Net sales in CapAble amounted to SEK 0.0 million (1.1) during the period. Operating profit was SEK -2.6 million (-1.6).

Parent Company, January-September

Net sales in the Parent Company amounted to SEK 382.4 million (369.7) and profit before tax was SEK 137.9 million (134.1). The Parent Company's profit includes the write-down of the loan to the subsidiary in Japan by SEK 14.4 million. No new loans have been paid, and the write-down refers to currency adjustment of the existing loan. Cash flow in the Parent Company totalled SEK 3.2 million (-41.3).

FINANCIAL PERFORMANCE IN THE THIRD QUARTER OF 2016

Net sales, third quarter 2016

Consolidated net sales amounted to SEK 126.0 million (106.0), which is an increase of SEK 20.0 million (19%). Excluding foreign exchange effects, net sales were up by 17%.

Compared to the previous quarter, net sales declined by SEK 10.0 million, which is normal for the third quarter when there is lower activity among the distributors and suppliers as a result of the customary summer vacation period in Europe.

Sales by segment, third quarter 2016

BUSINESS UNIT PAEDIATRICS, THIRD QUARTER

Net sales in BioGaia's core area Paediatrics amounted to SEK 99.0 million (88.9), an increase of SEK 10.1 million (11%) (no material foreign exchange effects arose during the period). This is mainly due to increased sales of Protectis digestive health tablets and higher royalties on Growing Up Milk for children over the age of one year.

Sales of drops were up slightly compared to the same period of last year. Drop sales rose dramatically in Europe, were largely unchanged in the USA and Canada and fell sharply in Rest of the World (Brazil) and somewhat in Asia.

Sales of Protectis digestive health tablets increased compared to the same period of last year. Tablet sales were up in all markets except the USA and Canada.

Sales of cultures for infant formula rose compared to the same period of last year.

Royalty revenue from Nestlé for the use of Lactobacillus reuteri Protectis in Growing Up Milk for children over the age of one year increased compared to the same period of last year.

Royalty revenue from the collaboration agreement with Nestlé (for more information see above under other sales January-September) in Business Unit Paediatrics amounted to SEK 2.6 million (0.4).

Compared to the previous quarter, net sales in Paediatrics were down by SEK 7.7 million.

BUSINESS UNIT ADULT HEALTH, THIRD QUARTER

Net sales in Business Unit Adult Health amounted to SEK 22.6 million (12.6), an increase of SEK 10.0 million (79%) (excluding foreign exchange effects, 70 %) compared to the same period of last year. The increase is mainly attributable to higher sales of Protectis digestive health tablets and Prodentis oral health lozenges.

Sales of Protectis digestive health tablets rose in Europe, Asia and Rest of the World (South Africa) compared to the same period of last year. In the USA and Canada, no digestive health tablets are sold in the Adult Health segment.

Sales of Prodentis oral health lozenges increased primarily in Asia but also in Europe. In the USA, Canada and Rest of the World, sales of oral health lozenges declined.

Sales of Gastrus were low during the quarter. Gastrus has been launched in Italy, Spain, Singapore and the USA during 2016. As earlier, Gastrus is also sold in Japan and South Korea.

Compared to the previous quarter, sales in Adult Health were down by SEK 3.1 million.

OTHER SALES, THIRD QUARTER

Other sales amounted to SEK 4.5 million (4.5).

Other sales include royalty revenue of SEK 3.5 million (3.5) from the collaboration agreement that was signed with Nestlé in March 2014. For more information, see above under sales for January-September 2016

SALES BY GEOGRAPHICAL MARKET, THIRD QUARTER

Sales in Europe increased by SEK 26.0 million (49%) to SEK 79.5 million.

Sales in the USA and Canada fell by SEK 1.6 million (33%) to SEK 3.2 million.

Sales in Asia rose by SEK 5.9 million (52%) to SEK 17.4 million.

Sales in Rest of the World declined by SEK 10.4 million (28%) to SEK 26.0 million.

Gross profit, third quarter

Gross profit amounted to SEK 91.3 million (71.8), which is an increase of SEK 19.5 million (27%). The total gross margin rose from 68% to 72%.

Gross margin for Business Unit Paediatrics increased from 67% to 73%. This is attributable to higher royalty revenue for the use of bacteria cultures in Growing Up Milk for children over the age of one year (with a margin of 100%) and a somewhat higher margin for drops.

Gross margin for Business Unit Adult Health fell from 66% to 64%. This is because the margin on digestive health tablets and oral health lozenges has decreased somewhat as a result of higher costs for bacteria cultures.

Operating expenses, third quarter

Total operating expenses (excluding IBT) were up by 22% to SEK 46.0 million compared to the same period of last year.

Selling expenses (excluding IBT) amounted to SEK 24.7 million (21.3), an increase of SEK 3.4 million (16%) mainly owning to higher costs for marketing activities and increased personnel costs.

Administrative expenses amounted to SEK 4.9 million (3.9), an increase of SEK 1.0 million (26%) due to higher personnel costs.

R&D expenses (excluding IBT) are reported at SEK 16.4 million (12.4), an increase of SEK 4.0 million (32%) resulting mainly from higher costs for patents, research projects and clinical studies.

Other operating income refers to foreign exchange gains on operating receivables and liabilities. This amounted to SEK 3.0 million (2.0) during the quarter.

Operating profit, third quarter

Operating profit (excluding IBT) was SEK 48.4 million (36.2), an increase of SEK 12.2 million (34%), and operating margin was 38% (34%). Including the subsidiary IBT, operating profit was SEK 48.4 million (29.7).

Profit before tax, third quarter

Profit before tax (excluding IBT) was SEK 45.9 million (33.5), up by SEK 12.4 million (37%).

Profit after tax, third quarter

Profit after tax (excluding IBT) was SEK 35.1 million (25.7), an increase of SEK 9.4 million (37%).

KEY EVENTS IN THE THIRD QUARTER

Launches in the third quarter

Distributor/licensee Country Product
Age D'or Singapore Gastrus digestive health tablets
Unilab The Philippines Protectis digestive health tablets
with strawberry flavour

Publication of study showing that BioGaia Prodentis reduces pregnancy gingivitis

A double-blind, randomized, placebo-controlled study on 45 women with pregnancy gingivitis showed that supplementation of L. reuteri Prodentis significantly reduced inflammation and plaque compared to placebo. The women with pregnancy gingivitis were enrolled in the study at the beginning of their third trimester. Participants were randomly provided with a supply of lozenges to be consumed twice daily until birth (approximately three months), containing either Prodentis or placebo. At the end of the treatment period, both the gingival index and plaque index of the probiotics group were significantly lower than in the placebo group. The study was published in Journal of Clinical Periodontology on 27 July 2016.

Agreement for the sale of drops, tablets and oral rehydration solution in Kenya, Nigeria and Ghana

In September BioGaia signed an exclusive distribution agreement with Phillips Pharma Group for the right to sell BioGaia ProTectis drops, tablets and oral rehydration solution Kenya, Nigeria and Ghana. The products will be sold under the BioGaia's brand and the launch is planned to start in Kenya at the end of 2016.

EMPLOYEES

The number of employees in the Group at 30 September 2016 (excluding IBT) was 105 (100).

SIGNIFICANT RISKS AND UNCERTAINTIES; GROUP AND PARENT COMPANY

Significant risks and uncertainties are described in the administration report of the annual report for 2015, on pages 6 and 7 and in Notes 29 and 30. No significant changes in these risks and uncertainties are assessed to have taken place at 30 September 2016 aside from the fact that the subsidiary IBT, which is developing a drug for premature newborns, is no longer part of the Group following the distribution of the shares in the company to BioGaia's shareholders at the end of March.

ACCOUNTING POLICIES

In all material aspects, this interim management statement has been prepared in accordance with Nasdaq OMX Stockholm's Guidelines for preparing interim management statements. Disclosures according to IAS 34 Interim Financial Reporting are provided both in the notes and in other parts of the interim management statement. The accounting policies applied in the consolidated profit and loss account and balance sheet are consistent with those used in preparation of the most recent annual report. The financial statements and segment information are consistent with the presentation used in the interim reports presented in compliance with IAS 34, in order to achieve comparability in presentation between quarters. The interim management statement contains, among other things, comments from the Managing Director, although this is not required according to Nasdaq OMX Stockholm's Guidelines for preparing interim management statements. This information is nonetheless considered important in meeting the users' needs.

The company applies IFRIC 17, which means that the distribution of the subsidiary IBT is carried at the fair value of the assets that have been distributed. The difference between the carrying amount of the net assets distributed and the carrying amount of the unpaid distribution at settlement is recognized in the income statement. The profit in the income statement reflects the difference between the fair value (based on the average price of the share on the first day of trading on 29 March 2016) and the company's recorded value in the consolidated balance sheet on 18 March 2016.

New accounting standards

The applied accounting policies correspond to those presented in the annual report for 2015. A number of new standards and interpretations have been published but are not yet effective.

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, brand building and the sales organization.

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 that are sold under the BioGaia brand to a growing extent, successful clinical trials and an expanding distribution network that covers a large share of the key markets, BioGaia's future outlook is bright.

Consolidated statements of comprehensive income

Continuing operations

(Amounts in SEK 000s) Jan
Sept
Jan-Sept July
Sept
July
Sept
Jan-Dec Oct
2015-
Oct
2014-
2016 2015 2016 2015 2015 Sept
2016
Sept
2015
Net sales 395,946 378,850 126,049 105,984 483,241 500,337 500,224
Cost of goods sold -112,191 -115,629 -34,769 -34,154 -146,657 -143,219 -160,802
Gross profit
Selling expenses
Administrative expenses
Research and development expenses
Shares of profit of associates
Other operating expenses/expenses
283,755
-74,295
-15,673
-45,670
-400
5,362
263,221
-70,202
-13,534
-41,694
-
3,032
91,280
-24,734
-4,946
-16,383
123
3,037
71,830
-21,323
-3,938
-12,362
-
1,971
336,584
-93,735
-18,475
-53,283
-65
1,773
357,118
-97,828
-20,614
-57,259
-465
4,103
339,422
-96,394
-18,815
-57,255
-
6,825
Operating profit 153,079 140,823 48,377 36,178 172,799 185,055 173,783
Financial income
Foreign exchange gains/losses, forward exchange contracts
Financial expenses
1,364
-5,583
-130
282
1,578
-194
41
-2,501
-10
14
-2,639
-32
331
5,106
-259
1,413
-2,055
-195
528
-2,313
-214
Profit before tax
Tax
148,730
-36,356
142,489
-30,287
45,907
-10,845
33,521
-7,792
177,977
-40,594
184,218
-46,663
171,784
-38,640
PROFIT FOR THE PERIOD FROM CONTINUING OPERATIONS 112,374 112,202 35,062 25,729 137,383 137,555 133,144
Discontinued operations (Distribution of IBT)
PROFIT FOR THE PERIOD FROM DISCONTINUED
OPERATIONS
67,935 -12,612 - -5,061 -16,092
PROFIT FOR THE PERIOD 180,309 99,590 35,062 20,668 121,291
Items that may be reclassified subsequently to profit or loss
Gains/losses arising on translation of the financial
statements of foreign operations 2,116 556 788 439 462
Comprehensive income for the period 182,425 100,146 35,850 21,107 121,753
Profit from continuing operations attributable to:
Owners of the Parent Company
Non-controlling interests
112,374
0
112,374
112,203
-1
78,922
35,062
0
35,062
25,730
-1
35,692
137,497
-114
137,383
Profit for the period attributable to:
Owners of the Parent Company
Non-controlling interests
180,593
-284
78,923
-1
35,062
0
35,693
-1
121,408
-117
180,309 78,922 35,062 35,692 121,291
Comprehensive income for the period attributable to:
Owners of the Parent Company
Non-controlling interests
182,709
-284
79,040
-1
35,850
0
35,128
-1
121,870
-117
182,425 79,039 35,850 35,127 121,753
Earnings per share
Earnings per share in continuing operations (average number of
shares), SEK
6.48 6.49 2.02 1.49 7.94
Earnings per share including discontinued operations (average
number of shares), SEK
10.42 5.76 2.02 1.19 7.01
Number of shares (thousands) 17,336 17,336 17,336 17,336 17,336
Average number of shares (thousands) 17,336 17,282 17,336 17,293 17,309
CONSOLIDATED STATEMENTS OF
FINANCIAL POSITION
30 Sept 31 Dec 30 Sept
Summary (Amounts in SEK 000s) 2016 2015 2015
ASSETS
Intangible assets - 16,225 15,112
Property, plant and equipment 82,395 83,934 84,199
Investments in associates 7,535 7,936 4,000
Other non-current receivables - 22 22
Total non-current assets 89,930 108,117 103,333
Current assets excl. cash and cash
equivalents
159,841 138,179 129,219
Cash and cash equivalents 201,554 226,882 219,803
Total current assets 361,395 365,061 349,022
TOTAL ASSETS 451,325 473,178 452,355
EQUITY AND LIABILITIES
Equity attributable to owners of the Parent
Company
369,450 395,851 374,129
Non-controlling interests -18 -18 97
Total equity 369,432 395,833 374,226
Provision for deferred tax 351 351 192
Other provisions - - 3,900
Interest-free current liabilities 81,542 76,994 74,037
TOTAL EQUITY AND LIABILITIES 451,325 473,178 452,355
Pledged assets 2,253 2,690 4,626
CONSOLIDATED CASH FLOW
STATEMENTS
Jan-Sept Jan-Sept July-Sept July-Sept Jan-Dec
Summary (Amounts in SEK 000s) 2016 2015 2016 2015 2015
Operating activities
Operating profit (including discontinued
operations)
147,917 124,662 48,377 29,690 152,184
Depreciation/amortization 5,051 3,949 1,674 1,259 6,548
Other non-cash items -1,672 -983 -954 -199 -813
151,296 127,628 49,097 30,750 157,919
Gains/losses on realized forward exchange
contracts
-1,393 1,651 -806 687 2,203
Paid tax -37,096 -35,267 -12,387 -11,409 -50,124
Interest received and paid 1,122 79 -78 -18 63
Cash flow from operating activities before
changes in working capital
113,929 94,091 35,826 20,010 110,061
Changes in working capital -13,726 8,784 17,163 4,106 7,440
Cash flow from operating activities 100,203 102,875 52,989 24,116 117,501
Acquisition of intangible assets - -9,037 - -1,337 -10,150
Acquisition of property, plant and equipment -3,510 -15,373 -836 -6,016 -17,780
Acquisition of financial assets - - - - -4,000
Cash flow from investing activities -3,510 -24,410 -836 -7,353 -31,930
Dividends -86,682 -86,355 - - -86,355
Distribution of shares in IBT -37,629 - - - -
New share issue, warrant programme - 15,844 - - 15,844
Cash flow from financing activities -124,311 -70,511 0 - -70,511
Cash flow for the period
Cash and cash equivalents at beginning of
-27,618 7,954 52,153 16,763 15,060
period
Exchange difference in cash and cash
226,882 210,666 148,205 202,752 210,666
equivalents
Cash and cash equivalents at end of
2,290 1,183 1,196 288 1,156
period 201,554 219,803 201,554 219,803 226,882

CONSOLIDATED STATEMENTS OF CHANGES IN

EQUITY

(Amounts in SEK 000s) Jan-Sept Jan-Sept Jan-Dec
2016 2015 2015
At beginning of period 395,833 344,591 344,591
Dividends -86,682 -86,355 -86,355
Distribution of shares in IBT*) -122,144 - -
New share issue, warrants - 15,844 15,844
Comprehensive income for the
period
182,425 100,146 121,753
At end of period 369,432 374,226 395,833

REPORTING BY SEGMENT – GROUP

(Amounts in SEK 000s) Jan
Sept
Jan
Sept
July
Sept
July-Sept Jan-Dec Oct
2015-
Oct
2014-
Revenue by segment – business units 2016 2015 2016 2015 2015 Sept
2016
Sept
2015
Paediatrics 313,792 312,957 99,007 88,900 389,561 390,396 406,595
Adult Health 69,394 54,626 22,567 12,569 74,667 89,435 77,624
Other 12,760 11,267 4,475 4,515 19,013 20,506 16,005
Total 395,946 378,850 126,049 105,984 483,241 500,337 500,224
Jan
Sept
Jan
Sept
July
Sept
July-Sept Jan-Dec Oct
2015-
Oct
2014-
Gross profit by segment – business units 2016 2015 2016 2015 2015 Sept
2016
Sept
2015
Paediatrics 227,001 213,786 72,293 59,334 266,391 279,606 269,882
Adult Health 44,275 38,678 14,517 8,265 51,907 57,504 54,258
Other 12,478 10,757 4,469 4,231 18,286 20,007 15,282
Total 283,754 263,221 91,279 71,830 336,584 357,117 339,422
Jan
Sept
Jan
Sept
July
Sept
July-Sept Jan-Dec Oct
2015-
Oct
2014-
Revenue by geographical market 2016 2015 2016 2015 2015 Sept
2016
Sept
2015
Europe 262,376 213,586 79,502 53,493 284,729 333,519 287,002
USA and Canada 26,898 24,370 3,222 4,763 35,231 37,759 37,139
Asia 46,814 38,247 17,361 11,377 52,130 60,697 50,262
Rest of the World 59,858 102,647 25,964 36,351 111,151 68,362 125,821
Total 395,946 378,850 126,049 105,984 483,241 500,337 500,224
Profit from discontinued operations Jan Jan July July Jan
(distribution) Sept Sept Sept Sept Dec
(Amounts in SEK 000s) 2016 2015 2016 2015 2015
Net sales - - - -
Selling expenses - -2,600 - -2,600 -2,600
Research and development expenses -5,101 -13,502 - -3,890 -17,974
Other operating income/expenses -61 -58 - 3 -41
Operating profit -5,162 -16,160 - -6,487 -20,615
Financial expenses -2 -8 - -1 -9
Difference between fair value of IBT's shares
and the carrying amount
73,099 - - - -
Profit for the period before tax 67,935 -16,168 - -6,488 -20,624
Tax relief due to group contributions - 3,556 - 1,427 4,532
Profit for the period after tax 67,935 -12,612 - -5,061 -16,092
Cash flow from discontinued operations: Jan
Sept
Jan
Sept
Jan
Dec
(Amounts in SEK 000s) 2016 2015 2015
Operating activities -6,781 -7,798 -30,895
Investing activities - -7,700 -10,150
Total cash flow -6,781 -15,498 -41,045
CONSOLIDATED KEY RATIOS Jan-Sept Jan-Sept Jan-Dec
2016 2015 2015
Net sales, SEK 000s1) 395 946 378 850 483 241
Operating profit, SEK 000s 1) 153 079 140 823 172 799
Profit after tax, SEK 000s 1) 112 374 112 202 137 383
Return on
- average equity 47% 28% 32%
- average capital employed 1) 40% 39% 48%
Capital employed, SEK 000s 369 783 374 418 396 184
Number of shares, thousands 2) 17 336 17 336 17 336
Average number of shares, thousands 17 336 17 300 17 309
Earnings per share in continuing
operations, SEK 1) 6,48 6,49 7,94
Earnings per share, SEK 3) 10,42 5,76 7,01
Equity per share, SEK 21,30 20,43 22,87
Equity/assets ratio 82% 83% 84%
Operating margin 1) 39% 37% 36%
Profit margin 1) 38% 38% 37%
Average number of employees 1) 104 96 98

1) Excluding discontinued operations (distribution of IBT)

2) No dilutive effect arose during the period 3) The ratios are defined according to IFRS

Definition of key ratios

The company presents certain financial ratios in the interim report that are not defined according to IFRS. The company is of the opinion that these performance measures provide valuable supplementary information to investors and the company's management since they enable evaluation and benchmarking of the company's performance. Since not all companies calculate financial ratios in the same manner, these are not always

comparable to the performance measures used by other companies. Consequently, these financial ratios should not be seen as a replacement for performance measures that are defined according to IFRS. The following key ratios are not defined according to IFRS unless otherwise stated.

Average number of shares: Weighted average number of shares during a certain period.

Capital employed: Total assets less interest-free liabilities.

Earnings per share: Profit attributable to owners of the Parent Company divided by the average number of shares (definition according to IFRS). Earnings per share in continuing operations: Profit from continuing operations attributable to owners of the Parent Company divided by the average number of shares.

Equity/assets ratio: Shareholders' equity divided by total assets.

Equity per share: Shareholders' equity attributable to the owners of the Parent Company divided by the number of shares.

Growth: Sales for the current year less sales for the previous year divided by sales for the previous year. Net financial items: The result from financial income and financial expenses.

Operating margin: Operating profit in relation to net sales.

Operating profit: Sales less cost of goods sold, selling expenses, administrative expenses, R&D expenses and other operating expenses plus other operating income.

Profit margin: Profit before tax in relation to net sales. Return on capital employed: Profit before financial items plus financial income divided by average capital employed.

Return on equity: Profit attributable to the owners of the Parent Company divided by average shareholders' equity attributable to the owners of the Parent Company

Reconciliation against IFRS

Return on capital employed Jan-Sept
2016
Jan-Sept
2015
Jan-Dec
2015
Operating profit
Financial income
Profit before financial items plus financial
153,079
1,364
140,823
1,860
172,799
5,437
income 154,443 142,683 178,236
Total assets 451,325 452,355 473,178
Interest-free liabilities -81,542 -77,937 -76,994
Capital employed 369,783 374,418 396,184
Average capital employed 382,984 361,551 370,500
Return on capital employed 40% 39% 48%
Paediatrics Adult Health Other Total
Jan
Sept
July
Sept
Jan
Sept
July
Sept
Jan
Sept
July
Sept
Jan
Sept
July
Sept
2016 % 2016 % 2016 % 2016 % 2016 % 2016 % 2016 % 2016 %
Change in sales by segment -
Organic growth
Foreign exchange effects
902
-67
0%
0%
9,404
703
11%
1%
13,029
1739
24%
3%
8,775
1223
70%
10%
1,493
-
13% -40
-
1% 15,424
1,672
4%
0%
18,139
1,926
17%
2%
Reported change 835 0% 10,107 11% 14,768 27% 9,998 79% 1,493 13% -40 -
1%
17,096 4% 20,065 19%

RELATED PARTY TRANSACTIONS

The Parent Company holds 100% of the shares in BioGaia Biologics Inc. USA, BioGaia Japan Inc, TwoPac AB and Tripac AB.

The Parent Company holds 90.1 % of the shares in CapAble AB.

On 29 March 2016, the shares in IBT were distributed to BioGaia's shareholders (see above).

Annwall & Rothschild Investment AB holds 740,668 class A shares and 759,332 class B shares, which is equal to 8.7% of the share capital and 34.1% of the votes in BioGaia AB. Annwall & Rothschild Investment AB is owned by Peter Rothschild, Group President of BioGaia, and Jan Annwall, a member of the Board of BioGaia AB. The only transaction that took place during the period was a dividend of SEK 5 per share.

FINANCIAL CALENDAR

10 February 2017 Year-end report 2016
3 May 2017 Interim management statement, 1 January – 31 March 2017
3 May 2017 Annual General Meeting in Stockholm
18 August 2017 Interim report, 1 January – 30 June 2017
25 October 2017 Interim management statement, 1 January – 30 September 2017

Stockholm, 25 October 2016

Axel Sjöblad Managing Director

This interim management statement has not been reviewed by the company's auditor.

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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 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 105 employees, of whom 38 are based in Stockholm, 30 in Lund, 28 in Eslöv, one in Raleigh, USA, seven in Hiroshima, Japan, and one in Shanghai, China.

Business model

BioGaia's revenue comes mainly from the sale of drops, digestive health tablets, oral rehydration solution and oral health products to distributors, but also of revenue from the sale of bacteria cultures to be used in licensee products (such as infant formula and dairy products), and to a certain degree also royalty revenue for the use of Lactobacillus reuteri in licensee products and sales of delivery systems such as straws and caps.

The products are sold through nutrition, food, natural health and pharmaceutical companies in some 90 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, 163 clinical studies using BioGaia's human strains of Lactobacillus reuteri have been performed on 14,000 individuals of all ages. The results have been published in 143 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)
  • Necrotizing 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: 2016-09-14 BioGaia's probiotic launched in Kenya, Nigeria and Ghana 2016-08-17 BioGaia Interim report 1 January – 30 June 2016 2016-08-08 BioGaia's oral health probiotic reduces pregnancy gingivitis

BioGaia AB Box 3242 SE-103 64 STOCKHOLM Street address: Kungsbroplan 3, Stockholm Telephone: +46 8-555 293 00, Corp. Identity no. 556380-8723 www.biogaia.se For additional information, contact: Axel Sjöblad, Managing Director, BioGaia AB, telephone +46 8-555 293 00 Margareta Hagman, Executive Vice President, BioGaia AB, telephone +46 8-555 293 00

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