BioGaia Aktie

Welcome to BioGaia Q2 Report for 2026.[Operator Instructions] Now I will hand the conference over to CEO, Theresa Agnew, and CFO, Alexander Kotsinas. Please go ahead.

Hi. This is Theresa Agnew, CEO of BioGaia, and I'm here with Alexander Kotsinas, and we are here to present our Q2 results for 2026. So some of the highlights of the quarter. Our growth, excluding currency effects, was 12% versus a year ago, and our EBIT margin is 30% with an adjusted EBIT margin of 33% for the quarter.

Overall, our net sales reached SEK 441 million, as I said, with growth, excluding currency effects of 12%. Specifically in the regions, in Europe, Middle East, Africa, our sales increased by 21%, excluding currency effects. In the Americas, increased by 16%, excluding currency effects, while Asia Pacific decreased by 6%, excluding currency effects due to order variability.

Our operating profit in the quarter was SEK 132 million, which is an increase of 22% and our EBIT margin was 30% versus the 27% last year for Q2. Our adjusted EBIT margin was 33% for the quarter. Overall, our net sales year-to-date reached SEK 813 million, which is growth excluding currency effects of 13%. Our BioGaia company strategy remains the same. Our first strategic pillar is Grow the Core, the core being our core health areas of the business, of which Gut Health, which includes colic, oral health and immune health are our biggest priorities.

Our second strategic pillar is what we call Expansion through Direct Markets, where we look at particular markets to take from a distributor partnership to a subsidiary or a direct market. We currently have 12 direct markets. And our third strategic pillar is Breakthrough Innovation. This is market creation opportunities for probiotics where people don't routinely use probiotics today. The foundations of our company are People & Culture, Investing for Profitable Growth, using Digital as an Enabler, both in how we go to market through our omnichannel approach as well as digitizing our business internally, Driven by Science, which has been a foundation for over 30 years and Sustainable Solutions, highlighting the importance of sustainability to our business.

So how are we delivering on our strategy? In terms of Grow the Core, in the quarter, we drove growth for both the Pediatric and Adult segments. We are investing in our marketing and selling activities to grow strong growth in our direct markets. We are continuing to roll out our new products. We had originally launched BioGaia Gastrus Pure Action in October of 2024. We continue to roll that out this year. We also launched last year BioGaia Prodentis Fresh Breath. We're continuing to roll that out to more markets this year.

And we just recently, in May, launched our next-generation patented probiotic drops called BioGaia Protectis Plus. BioGaia Protectis Plus will be available in addition to our original Protectis drops. And in terms of Expansion through Direct Markets, we continued our launch in Germany and Austria in Q2, that originally launched in January this year. One of our largest direct markets, the U.S., had record sales in Q2. And we've seen strong performance in France in Q2.

In terms of our Breakthrough Innovation, skin health is one of our exciting new areas, and we expanded our portfolio in the quarter with 2 additional new products and updated our design across the full range. So some of the launches that we had in the quarter, as I mentioned, we launched BioGaia Protectis Plus. We launched that in the U.K., Ireland as well as in Sweden. We launched our Pharax drops in a number of markets. And as I said, we launched our 2 new skin care products, so a Face & Body lotion and a Balm-to-Milk Body Wash, both microbiome-friendly and organic containing ingredients. And those launches happened in the U.S. and China.

Some of the key events for the quarter. On April 28, we published some new scientific findings on one of our patented technologies. It's called LongevityGuard. It is a desiccant technology that goes into our drops products and our probiotic ointment that improves the stability and shelf life of our probiotics so that they live throughout the shelf life. May 7, we announced our launch of BioGaia Protectis Plus, which is, as I mentioned, a proprietary patented combination of our strain DSM 17938 as well as BG-R46.

Also on May 7, at our Annual General Meeting, we elected a new Board member to our Board of Directors, Amy Byrick. And then on June 18, we announced the new product launches that I mentioned, the Lotion and Wash for the BioGaia Skin Care portfolio. Our growth, as I said, for Q2 was 12% organic growth. As you look at it from a Pediatric and Adults segment standpoint, pediatrics grew 9% organic growth and adult segment grew 23% organic growth.

And a little bit more on the segments. If you look at the quarter, as I said, excluding currency effects, Pediatrics grew 9%, Adult Health 23%. But if you look at the total for the year-to-date, Pediatrics grew 11% organic growth and Adult grew 21%. In terms of Pediatrics for the quarter, sales mainly increased in France, U.S. and Brazil. In terms of Adult Health, sales increased in our Protectis tablets and sales also increased in Asia Pacific, mainly in Indonesia and Japan.

So overall, our Pediatric segment for the quarter is 75% of our sales and year-to-date is 74% of our sales. Now by region, as I said previously, Europe, Middle East, Africa increased by 21%, excluding currency effects, mainly in France and Poland. These were strong markets for us. In addition, other strong markets in EMEA were Germany as well as U.K. In Asia Pacific, our sales decreased by 6%, excluding currency effects. It was lower in our sales in the Pediatric segment, while the Adult Health segment did increase.

And as I said previously, the sales were lower mainly in China and South Korea. This was due to quarterly variations for individual orders, so order variability. And in the Americas, which includes Latin America as well as North America, our sales increased by 16%, excluding currency effects. This is due to higher sales in both the Pediatric and the Adult Health segment and sales increased mainly in the U.S., Canada and Argentina. I will now turn it over to Alex to go through the financials in more detail.

Thank you, Theresa. So to summarize, as we heard Theresa mentioned, we had a sales growth of 9% from SEK 405 million to SEK 441 million in the quarter. Our gross profit also increased with 9%, and our operating profit increased with 22% and we had a margin of 30% in the quarter compared to 27% 1 year ago. If we look at the sales, as we heard, we had a growth of 9%, and we had a negative currency effect of 3% and thus, growth, excluding currency effect of 12% in the quarter.

Our gross margin in the quarter was 73%, which was at the same level as last year. We had 1 percentage point higher margin in the Pediatric segment. And 1% lower in the Adult segment. That variation is mainly due to mix effects. There are some movements between different products and geographic markets that explains the variation. And then if we look year-to-date, we have a margin of 72% versus 73%, 1 year ago. With a slightly lower margin in the Adult Health segment.

If we look at our operating expenses, our total operating expenses were SEK 189 million versus SEK 186 million, so 2% higher versus 1 year ago. Our Sales and Marketing expenses increased due to higher expenses for sales and marketing activities, mainly in our subsidiaries, for example, in France and Germany, which are new markets where we were spending less 1 year ago. The Sales and Marketing expenses also include a onetime expense of SEK 11.3 million.

Our R&D costs decreased mainly due to lower cost for clinical studies. It's a normal variation between the quarters. And we have a positive effect in the Other OpEx due to some exchange gains on receivables of SEK 7 million. And therefore, we have an OpEx of SEK 189 million versus SEK 186 million, 2% higher. And on an adjusted basis, our OpEx was SEK 177 million versus SEK 186 million, which is then 4% lower compared to 1 year ago.

And then if we summarize and look at our profit and loss statement, again, we see an increase in sales of 9%, an increase of OpEx at a lower extent of 2%, and therefore, our EBIT then increases with 22%. And on an adjusted basis, our EBIT increases with 32%. And we then have a margin of 30% in the quarter. And on an adjusted basis, our margin is 33%. And profit, earnings per share of SEK 1.02 versus SEK 0.87, an increase of 17% in the quarter.

If we look at our cash flow, cash flow from operating activities amounted to SEK 51 million. The decrease in cash flow from operating activities compared to the same period last year is mainly due to a negative change in working capital. It is also, I would say, a normal variation between the quarters, whereby we have some higher receivables, a bit higher inventory and lower payables, and all 3 giving a negative effect in the change in working capital.

And the cash flow from financing activities amounted to minus SEK 466 million. That then includes the additional purchase payment that we did for Nutraceutics, our U.S. company, of SEK 59.5 million, which we paid at the 1st of April in this quarter. And we also had dividends in the quarter of SEK 405 million. And then the net effect then is the cash flow for the period of minus SEK 428 million versus minus SEK 624 million in the same quarter last year. And we have a cash at the end of the period of SEK 446 million. So with that, I hand over to Theresa for some concluding remarks.

So in summary, as we said, our second quarter showed growth, excluding currency effects of 12%. Both our segments grew for the quarter. So Pediatric segment growing 9%, excluding currency effects and Adult segment growing 23%, excluding currency effects. And the increases were primarily driven by our Protectis drops, our Prodentis and our Gastrus Pure Action products. Europe, Middle East, Africa is regaining momentum, as you saw, in key markets, following a period that we had a transition from when we went from partner distribution to direct market operations in France and Germany and Austria.

So our sales overall increased by 21%, excluding the currency effects. France, as I said, was established as a direct market in April 2025, Germany in January 2026, both contributed to the strong performance in Europe, Middle East, Africa. For Asia Pacific, our sales decreased by 6%, excluding currency effects. This was mainly due to the lower sales in the Pediatric segment. The Adult Health segment increased, as I mentioned previously, but the sales decreased mainly in China and South Korea and our partners in those markets, and that was due to quarterly variations in the individual orders.

The Americas delivered strong performance with a 16% growth, excluding currency effects. Both Canada and the U.S. had robust growth in sales of our adult products, specifically Prodentis and Gastrus Pure Action as well as double-digit growth in sales of our Protectis drops. Our operating margin for the quarter was 30%. Our adjusted operating margin was 33%. So overall, our year-to-date adjusted operating margin is 30% compared to 27% last year. We are announcing that we will host a Capital Markets Day in London in December of this year with more information to come on that.

And we remain, of course, focused on driving our growth by leveraging our strong scientific foundation that we have built over many years. We are expanding our presence in key markets by continuing to launch new products in these markets and, of course, investing in increasing our brand visibility and our brand recommendations through health care professionals. So we will open it up now for any questions that you may have.

[Operator Instructions] The next question comes from Kristofer Liljeberg from DNB Carnegie.

I have 4 questions, but they are short, I promise. So first, the higher investments compared with the first quarter last year -- or yes, the second quarter last year, if you could just comment on that. And I wonder about the gross margin improvement second quarter versus first quarter, if that's just mix effect or if it's something else? The third question is if you could give this figure of direct sales market proportion of total sales in the quarter or year-to-date? And finally, if you are willing to comment about when you expect the China distributor to start ordering again?

What was the fourth question?

When do you expect the distributor in China to start order again.

Okay. So the first 2 questions, I'll have Alex address.

So the investments in the quarter, yes, that's mainly BioGaia production, and we are ramping up our investment levels. We are expanding our manufacturing capacity. So we will see a higher CapEx level for this year and also next year. And that is why you have a higher CapEx. We've actually had an abnormally low CapEx for the last year or two because we have been preparing.

Is this -- yes. Is this the level we saw in the quarter, is that you think a good representation for the remainder of the year or...

It will vary a bit going a bit up and down, but it's a bit difficult to say. It depends on the speed of that deployment of those investments. But I think for this year, we could have investments around SEK 30 million to SEK 40 million in total.

Okay. That's helpful.

Yes. And then for the gross margin, yes, as you guessed, it's mainly due to normal or variations between geography and products, not really that we have changed any pricing or anything similar.

And then in terms of the direct market percentages, so for the quarter, our direct markets are 41% of our growth. And then year-to-date is 45%.

And then in terms of...

The growth -- do you mean of the growth or of the actual sales?

I'm sorry, of the sales. Apologies. Of our sales. So 41% for the quarter is direct market, 45% of our sales for the year-to-date for direct markets.

And yes -- but I guess if you have a quarter, and that leads us into the -- my final question. So if APAC is picking up again, I guess, that number should go down? Or is the trend so strong that the direct sales proportion will still continue up this year, would you say?

No, that number will go down because we had lower orders for China and South Korea in the first half of the year. So we do expect, and that gets to your fourth question that our China distributor will increase their orders in Q3 and then larger orders in Q4 as well.

Okay. So do you expect the China third quarter sales to be up year-over-year?

Yes, we do.

The next question comes from Filip Wetterqvist from SB1 Markets.

I just have a couple of questions. The first one on the extraordinary sales costs. Can you elaborate a little bit more on what that relates to? And was it -- did it impact cash flow here in the quarter?

Well, in terms of the overall expense, it's a onetime expense, and this is confidential for competitive reasons. So we don't share the specifics on that, but it is a onetime selling expense.

And it did impact the cash flow in the quarter. That's correct.

Okay. And then my second question is, still on the selling costs and excluding the extraordinary expense, selling expenses grew 3% year-over-year, below the 12% organic growth. Should we assume selling expenses to grow slower than sales from Q2 onwards? Or is this a good run rate for H2? Or how should we think about the selling expenses going forward?

It's a bit tricky to give an exact answer on that. On one hand, yes, we are trying to contain our costs. I mean, last year, we did have this global marketing campaign, which we did, for example, which we're not doing this year. So we will have a lower sales and marketing cost for that. On the other hand, we are ramping up our costs in the sales and marketing area in terms of, for example, direct operations in Germany that we didn't do last year. And also, we're ramping up in France and some other direct markets. So we don't really give an exact guidance on the proportion of the marketing and sales spending. But as we mentioned before, we are committed to try to keep our total OpEx basically flat for this year.

[Operator Instructions] The next question comes from Mattias Vadsten from SEB.

I have 2. So in EMEA now, when you look at the performance, would you say it's anything in that region that is not performing according to plan? Or is it really a good performance across the key markets in EMEA?

Yes. So in terms of Europe, Middle East, Africa, there are a couple of countries, I would say, not performing to plan. So Turkey is one where we have switched our distributor partner earlier this year. So that business is going to start ramping up in the second half and has been poor in the first half of this year and also the second half of last year. So Turkey. And I would also say Italy is slower than expected in terms of orders from our partner. So that has to do with some of the probiotics market in Italy overall declining, but we have high share and we're growing share in that market.

Okay. Good. That's a clear answer. And then next one, the probiotic drops, the Protectis Plus. Can you talk about the launch plan in your key regions here going ahead and maybe the development that you anticipate versus the current Protectis drops product that you sell?

Yes. So we just launched in the U.K. in May, and we actually launched at a baby show with about 30,000 consumers and received very positive feedback on the new product. So the product so far has been launched in the U.K., Ireland and Sweden since our announcement on May 7. And then we will be rolling it out over time in other markets.

It all depends on the regulatory situations. Because this is a new strain, it does take an additional registration in a lot of our markets. So it will take time. Such as in the U.S., you need to have GRAS certification for a new strain. So there are a number of things from a regulatory perspective that will cause the launch to be over many years coming.

Okay. Good. And in terms of is this part of the production investments that you do now? Or let's say, that if you could launch in the U.S., would that be doable with the production setup that you have?

Yes. Yes, definitely. We have plenty of capacity. We actually had a new EasyDropper line installed, which is actually the main U.S. SKU is an EasyDropper format. So that was installed about 2 years ago. So we have plenty of capacity. And also, we have capacity on our glass bottle line as well.

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

So thank you for your questions, and we are happy to present our Q2 results, and we will be back again when we have Q3. Thank you.

Welcome to BioGaia Q1 report for 2026.

[Operator Instructions]

Now I will hand the conference over to CEO, Teresa Agnew and CFO, Alexander Kotsinas. Please go ahead.

This is Theresa Agnew, CEO of BioGaia and we are here to present our Q1 2026 results. So in terms of the highlights, we have growth, excluding currency effects, of 15%. Our EBIT margin for the quarter is 27%, and overall, our free cash flow is SEK 67 million. Our net sales reached SEK 373 million. And as I said, organic growth of 15%, 2% growth when you include currency effects. By region, our Asia Pacific region increased by 6%, excluding currency effects. In the Americas, we increased by 12%, excluding currency effects. And for Europe, Middle East, Africa, we increased by 24%, excluding currency effects.

Our operating profit for the quarter was around SEK 101 million, which is 4% growth. And our EBIT margin, as I said, was 27% comparing to 27% same quarter last year. To remind you of our company strategy, we have 3 strategic pillars: Grow the core where we focus on growing our core health areas, gut health of which colic is apart, oral health and immune health. Our second strategic pillar is what we call expansion through direct markets. So focusing on growing our current 12 direct markets. And focusing our marketing and selling and investment activities in those markets to drive growth ahead of market.

And our third strategic pillar is what we call breakthrough innovation, where we work on new products that are in new areas, some new market creation opportunities for probiotics. And our foundations are, of course, our people and our culture, investing for profitable growth, using digital as an enabler of the business, both in how we go to market in our omnichannel approach as well as how we digitize internally to make us more productive and efficient, driven by science, which has been a foundation for us for over 35 years and sustainable solutions.

So how are we delivering on our strategy? In terms of grow the core, for the quarter, we are driving growth in both the Pediatric and Adult segments. We are investing, as I said, in marketing and selling activities to drive strong double-digit growth in direct markets. We're continuing the rollout of new products. We launched a new product, [indiscernible] action in Finland originally in October 2024. And now we have rolled it out to approximately 12 markets. And it is now the third highest growth contributor to our overall business in terms of millions SEK for a second quarter in a row, it was our third largest growth contributor in Q4 and again now in Q1 2026.

And we are also rolling out a new product, Prodentis Fresh Breath, which launched last year in Q3, and we continue to roll that out into more markets. In terms of expansion through direct markets, we launched Germany and Austria earlier in Q1 and and that is doing really well with strong growth ahead of our plan. France and Canada actually had record sales in Q1. So both of those direct markets doing very strongly. And then U.S. continues in Q1 with its strong double-digit growth trend.

So direct market is performing extremely well. In the breakthrough innovation area, we have our BioGaia new sciences focus, which is on skin health, and we continue to roll out our probiotic appointment to more and more countries around the world. And we have some exciting news to announce a new product launch in our pediatrics area, this is called BioGaia Protectis Plus. This is our next-generation patented probiotic baby drops which I think, as you know, this is a dual strain product. So this contains our original Protectis strain, which is DSM 17938 and a new patented strain, which we call VGR 46.

Our current Protectis drops will remain available in the market. So this will be an additional product launch which will round out our premium portfolio in terms of baby drops. We just completed a clinical study where we achieved positive results both in efficacy and safety. So we will be writing a manuscript and submitting this for publication for the clinical study. So with this product, we get the benefit of additive probiotic effects. So it's supported by numerous preclinical studies that have been published such as things about the survival and the activity in a bio rich environment, which is very important for bacteria to survive.

The BGR46 also increases melatonin induction in the intestinal cells. So this is a really positive differentiator in this strain. This new strain also has higher production levels of anti-inflammatory compounds, such as adenosin and this new strain is even better adapted to the infant gut in a milk-rich environment. So there are a number of things that we've studied preclinically about this new strain, BGR46, which provide additive probiotic effects.

But as I said, this is a new product that will be available in addition to our original BioGaia Protectis drops. Our first launch is actually this week in the U.K. and then we will follow with additional rollouts by market over this year and into next year. So very exciting news for us in terms of a new product launch, our next-generation probiotic drops. In addition, with other launches in the quarter, as always, our existing product portfolio, we talk about other launches in -- as we expand into new countries.

So we -- just a couple of the examples. In Sweden, we launched our Prodentis Fresh Breath lozenges. In Germany, of course, we launched some new products in the quarter as we started our direct market presence in the quarter. also prudent is fresh bread lozenges launched in the U.K. and Finland in this quarter. Malaysia launched our BioGaia skincare probiotic ointment. So a number of other launches of products within the quarter. And some of the other key events, we had quite a bit of news in the quarter. February 3, we announced that our fourth quarter would exceed market expectations.

In February, we signed a renewed distribution agreement with a long-standing partner, Evo Pharma. And they cover Central Eastern Europe as well as Switzerland for us. On March 17, we also announced exercising the option to acquire the remaining 20% of the shares in Nutraceutix, which is our company in the United States. On March 20, we announced also an exciting clinical study publication. It's a 10-year follow-up study from when infants were given our Protectis drops. And we saw that there was a markedly lower prevalence of functional abdominal pain in these children after they had received our drops in the first 3 months of life.

And then finally, at the end of April, we also published new scientific findings around our patented longevity guard technology, which is our Desikan strip that goes into our drops products as well as our probiotic ointment to improve stability and shelf life of our probiotics so that they last through the life of the product, the 24-month shelf life. So a lot of interesting, exciting news that we had during the quarter.

In terms of growth, as we look at it across our segments, you can see the past growth by quarter. So in pediatrics for Q1, we grew by 13%, excluding currency effects. And in the adult segment, we grew by 18%, excluding currency effects. In pediatrics, we saw very high sales in the U.S. and also France in the quarter. And in adults, we saw very high sales in EMEA, Asia Pacific, and we saw a strong growth in South Africa as well as Japan.

In addition, as you look at our segments of Pediatrics and Adult health. For the quarter in Pediatrics, we grew 13%, excluding currency effects. Adult Health, we grew 18%, excluding currency effects. So strong growth for both segments. And currently, for the quarter, 73% of our sales is in the pediatric segment.

In terms of our regional sales, I highlighted this in the beginning, EMEA grew 24%, excluding currency effects. Asia Pacific grew 6% and and Americas grew 12%. With EMEA, we saw strong growth in both the pediatric and adult segments. In Asia Pacific, we saw strong growth in Japan and Australia, our direct markets in Asia Pacific. Also, sales for the quarter were negatively impacted by some quarterly variations that we saw for China between Q4 and Q1.

And in the Americas, as I said, we saw 12% growth excluding currency effects, with strong growth in the U.S. and Canada and growth in the quarter also strong for both the Pediatrics and the Adult Health segment.

So now I will turn it over to Alex to go through the financials in some more detail.

Thank you, Theresa. So to summarize, we had a sales increase in millions of SEK from SEK 373 million -- from SEK 366 million to SEK 373 million. We had a gross profit decrease of 1% with a margin from 73% to 72%. We had an EBIT increase of 4% and a margin of 27%. If we look at the sales, as we heard, we had an increase organically of 15%.

However, we had very strong negative currency effects of 13% and the net increase that was 2%. The gross margin for the quarter was 72% versus 73% in the same quarter last year. We had a slightly lower margin for both Pediatrics and Adults. And the main reason for the lower margin is the strengthening Swedish kroner versus mainly the dollar that is affecting the gross margin here. In terms of our operating expenses, the operating expenses were SEK 166 million versus SEK 171 million in the same quarter last year, which is 3% lower compared to last year.

This is mainly due to the other OpEx line, where we have a negative cost of SEK 6 million versus a cost of SEK 24 million in the same quarter last year. If you exclude that effect, we have an increased sales and marketing cost of 17%. The main reason for the increased sales and marketing cost is that we are have this increase in sales in different markets, and therefore, we have higher costs. We're basically investing in our growth here.

In terms of R&D, we also have a slight increase of 13% and and admin is also an increase of 24%. It's partly due to some virilization of some costs. If we look at then our P&L like we heard, we had a sales of SEK 373 million and OpEx SEK 166 million and thereby an EBIT of SEK 101 million versus SEK 97 million in the same quarter last year, an increase of 4% and a profit after tax of SEK 79 million versus SEK 80 million, which is a slight decrease of 1% and earnings per share of SEK 0.78, which is a slight decrease of 1%.

If we go over to the cash flow, we have a cash flow from operating activities before changes in working capital of SEK 66 million. And we have a positive change in working capital of SEK 5 million, leading to a cash flow from operating activities of SEK 70 million versus SEK 36 million in the same quarter last year. We have a very low cash flow from investing activities of SEK 1 million. It was also low in the same quarter last year. And the cash flow from financing of minus SEK 2 million, leading to a cash flow for the period of SEK 67 million versus SEK 33 million in the same quarter last year.

And cash at the end of the period of SEK 871 million versus SEK 1.25 billion last year.

So with that, I hand over to Theresa.

Great. So in conclusion, as we said, our first quarter showed growth, excluding currency effects of 15%. We are happy to report that both our Pediatric segment and our Adult segment grew double digits. And as we said, this increase is primarily driven by our BioGaia Protectis drops, BioGaia Prodentis and our BioGaia Gastrus Pure Action, one of our new launches from 2024. Europe, Middle East, Africa is regaining momentum in some of the key markets. We had last year a period of transition as we were going from a partner run business to now taking some markets direct.

So we are through that period of transition for one of our largest markets, France, so that is really showing in our results. And overall, as we said, in Europe, Middle East, Africa, our sales increased by 24%, excluding currency effects. And as I said, France performed well. Germany also performed very well. We just launched in January. And as I said, we are ahead of plan. So both of those markets have contributed strongly to our performance in Europe, Middle East, Africa. In Asia Pacific, as I said, we had strong growth in Australia, Japan, Vietnam. We had some order variability in China in the quarter.

And then specifically in Australia, the Gastrus product line was a key contributor to the positive development in our sales as well as our BioGaia Protectis drops. And in Japan, we saw increased sales through not only our own e-commerce channels, but also very strong collaboration with local wholesalers for distribution in bricks and mortar retail. The Americas overall delivered strong performance with 12% growth when you exclude currencies. Both of our direct markets, Canada and the U.S. had strong double-digit growth. Strong sales of adult products such as BioGaia Prodentis as well as BioGaia Gastrus Pure Action and then also strong double-digit growth of Protectis drops in the U.S.

And as we said, our operating margin at 27% for the quarter, and as a company, we remain focused on driving this sustainable growth. We leverage our scientific foundation, as you heard from us, a number of different scientific publications in the quarter. Now also in second quarter, a launch of a new product that has a strong scientific foundation with all of our preclinical studies and now a new clinical study. And we are expanding our presence in our key markets, and we're increasing our brand visibility with a strong focus on our marketing and selling activities.

So I open it up now for any questions.

[Operator Instructions]

The next question comes from Mattias Vadsten from SEB..

First one relates to the next-generation patented probiotic drops that we press released this morning. So a few questions there. So there are additive effects of the combination, as you say, observed preclinically. But they have also been positively studied, as you mentioned and shown to be safe in the randomized double-blinded clinical study.

So just to clarify exactly maybe what that means and also to that? Do you see the prior colic drops product being cannibalized now when you launch in 3 markets and also towards what year does the patent last. Sorry for many questions though.

Thank you for that. So the Protectis Plus product the next generation. We have a clinical study. So as we said, a double-blind, randomized, placebo-controlled study. So we are not talking specifically about the results of that study yet because we are submitting it for publication. But when we say a positive study, meaning in efficacy as well as safety. As well, this product will be premium to the existing product, so around a 15% price premium. We do expect some cannibalization over time. It will take a while for the new product to be launched in numerous markets because it is a new strain and in many markets, it requires specific registrations for a new strain. So this will happen over time, but we do eventually expect some cannibalization, but it will be premium priced.

So it's a full patent of 20 years.

And do you have -- can you share the plans when to launch it in the U.S.

For the U.S., we need to get what's called gross approval for a new strain. So that process is starting, and we can't really predict exactly how long that takes. It depends on the review by the regulatory authorities.

Okay. Good. Yes, that's good news. And looking forward to read the publication later. On the Gastrus Pure Action product. So I'm just keen to hear how many markets it has been launched in and if you see in major countries would expect rollout coming months here? That's the second one.

So it has been launched thus far in 12 countries. So there will be more markets that will be coming through. We don't specifically announce which markets when because it all depends on registrations and regulatory requirements. We have launched it, though, already in some of our bigger markets, such as the U.S. and Canada. And we have pending to launch it in some of the European markets. So we will be launching it upcoming in Italy, for instance.

So it hasn't launched there yet. And then in Asia, it has launched in a number of our larger markets, but mainly through online channels.

That's very clear. Then I was keen to hear the sort of status on Eastern Europe, if that has recovered in line with your expectations. And if you -- so the new agreement with Evo Pharma, is that similar to the prior one or any changes there?

No major changes. It's very similar to the prior one. We just -- when we do these new contracts -- we then agree on minimum quantities in terms of volume. So no major changes.

The next question comes from Mattias Haggblom from Handelsbanken.

So firstly, on the margin expansion, I think the messaging into FY '26 has been around operating leverage and margin expansion. And if we adjust for other operating income, which was mainly it was positive this year and a large negative last year. We're looking at an EBIT margin contraction and not flat year-over-year, which is the reported one. So -- so was this quarter an outlier? Or have you, to any extent, walked away from the previous commitment of expanding margins for 2026?

And then secondly, again, on the new strain and press release this morning, you highlighted a number of characteristics that make Protectis class better product. But I guess some parents with infants in colic is what matters. So on more heart endpoints, can you talk about how the product differs, if at all, versus the original protective?

Yes. So I can start with the margin. So we're still committed to improve our margin during this year. That will -- that is definitely our plan. and it should happen in the coming quarters, basically. And the assumption of cost control and also increased sales that will improve our margin in percentage.

Then for the new strain, maybe Teresa can give some comments.

Yes. So we did see in our clinical study, a positive reduction in crying time. So overall crying time as well as what we call unsoothable crying time. So that was significant. We did not compare the product specifically to Protectis because we use gold standard protocols to do double-blinded placebo-controlled trials. So the percentages of the reduction in crying time were higher than we've seen with the original Protectis, but we can't share the specific details because we want to get it published. And we did not compare the 2 products specifically.

The next question comes from Kristofer Lilyberg from DNB Carnegie.

Quite a number of questions. I might take a few and then get back in the queue. But start first, could you describe how you view the underlying growth momentum given that you were growing a strong 15% organically here despite that there should have been negative phasing effects between Q1 and Q4?

Yes. So we've seen some strong growth in Q1. This has been driven very strongly by our direct markets. So our direct markets are doing very well overall in terms of the performance in each market versus the competition growing ahead of the overall category. So we feel really good about the momentum we are seeing in our direct markets.

And how large part of sales is in direct markets now?

SP-11 For the quarter, it was actually 50-50. So 50% direct markets and 50% partner markets. But that's also -- we had some order variability. So some of our larger partners like China and Italy had some order variability. So we don't we don't anticipate that 50-50 will continue, but we will be getting to 50-50 overall, as we've said before, in the next year to 1.5 years.

Okay. Great. And the strong growth in EMEA here, which I think is primarily driven by Europe. How sustainable do you see this as given that this region hasn't been growing for the last 3 years, more or less.

I think it's overall sustainable for this year in terms of double-digit growth. We have strong performance, as we said in France. So now that we're through kind of the inventory that we see where we have higher inventory the partner and now our own direct market. We also have a new agreement that has started with a partner in Turkey, so Abbott Turkey. So we anticipate that will show some nice growth in the back half of the year. So overall, we feel we will continue with some strong double-digit growth in EMEA.

And do you think it's sustainable also 2027 and forward?

Yes, I do think it is sustainable because we have this presence of our direct markets that are large markets overall in the region. And also other markets that are partner markets doing well in addition, such as we talked about South Africa. Hopefully, we look at Turkey, where we've had a lower Q1 and first half of this year for Turkey, so we should see some nice growth next year.

Okay. I'll do 2 more questions. I hope that's okay. Follow-up on Matthias previous question on selling costs here, operating costs in the quarter. And I think you said that you will have come and higher sales driving better margin for the year. But when you say cost control, could we expect selling cost to become lower for the remainder of the year? Or is this the level where it should stay at.

Yes, we won't really provide that level of detail of guidance. But I mean, overall, like I said, I mean, we will keep our costs under control. I think we have said previously that we will -- our ambition is to keep them fairly flat compared to the last year overall. And then we will have an increase in sales like we had now in the first quarter. So it will vary a bit between the quarters.

We have some natural seasonal variations and so on between the quarters, for example. But overall, for the year, the ambition is basically for the total cost to be fairly flat excluding then maybe some currency effects that go a bit in different ways.

Yes. So that's important. So when you say flat operating costs, that adjust for the FX in the other line?

Yes. I mean, assuming that there are no major FX effects going up or down, so to speak. So excluding FX.

Yes. Okay. And then my final 1 on Protector. If you could confirm the price premium, was it 15%, i.e., 1, 5%...

That's correct.

That's correct. okay. And then when it comes to the clinical data, the crying time, is it possible to say just to -- that was statistically significantly lower.

Yes, yes, we can say that, but it is statistically significant.

[Operator Instructions] The next question comes from Mattias Haggblom from Handelsbanken.

I just had a follow-up question on the gross margin. Strength of Swedish krona versus the dollar was held to explain the gross margin contraction. But I mean this trend started already in Q2 last year, and I can't record this FX relationship has been brought up before often when we've had individual quarters with weak gross margin has often been historically related to product mix and campaigns or certain mix effects. So is there something I missed here? Or how -- and how should we think about that for the next couple of quarters then?

No, that's correct. I mean, it's partly a mix effect here also in the quarter for sure. But it is an FX effect, which, as you say, I mean, of course, we have had that effect previously as well, but it's a bit stronger in this quarter actually. And then we have -- we still have mix effects in the quarter, affecting things here.

The next question comes from Mattias Vadsten from SEB.

A few more questions. So one, curious to hear a bit more about Germany. In the letter, you say it contributed positively, which sounds quite good if it contributes to organic growth already now. So just to make sure I catch that correctly? And also, is it a fair assumption that Germany sales was fairly limited Q2 through Q4 in 2025.

Yes, that is correct. So yes, it is contributing already in Q1 organically. So that's very positive for us as we grow that business in Germany. And then you're correct with the other statement as well, that we had lower orders from our partner from Q2 to Q4.

Okay. Good. And in the U.S., the growth in the U.S., specifically in low currencies, was that 15%, 20% or 30%? Or can you comment on that?

Well, we will share the U.S. at the end of the year, one time a year. We don't specifically comment on it, but we can say that it is double-digit growth.

Okay. And then R&D expenses quite low in the quarter. Should we expect the seasonally higher R&D costs to come through in Q2? Or will it be lower now as this study is more or less done...

, 1 thing is we are doing what we call bridging studies -- clinical studies, whereas we look at our new patented streams, and we'll be bringing out further products, we will be spending in clinicals. So we will be looking at different indications Protectis Plus combination as well as other strains. So we will continue with clinical costs. But it is true, we have our 1 study that is completed, but then we have other studies also. I don't know if you want to add something more?

Yes. And then there will be some variations between the quarters, depending on those clinical studies when they start or end or include the subjects, et cetera. So it is a bit volatile, so to speak, that cost but it's probably -- it will probably increase going forward.

Good. And then last one should be fairly quick. So APAC with a 6% growth, if if the phasing effects would it be a growth more in line with past year's performance for FX?

Yes, overall, without that order variability, it would be more in line with previous.

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

So thank you for your time and listening to our Q1 2026 results. Thank you for your questions.

Welcome to BioGaia Q3 Report for 2025. [Operator Instructions]

Now I will hand the conference over to CEO, Theresa Agnew; and CFO, Alexander Kotsinas. Please go ahead.

Hi. This is Theresa Agnew, CEO of BioGaia. We are here to present our Q4 results. So first off, our financial highlights. We had strong organic growth for the quarter of 32%. We had an EBIT margin of 27% and overall free cash flow at SEK 77 million.

In terms of an overall summary, for the year, we hit SEK 1.5 billion, an increase of 14% in organic growth compared to last year and overall 8% growth adjusted for currency effects. In the fourth quarter, as I said, we had 32% organic growth and 21% including currency effects. We did experience some order variability in the fourth quarter as is typical across some of our quarters, and that was approximately SEK 35 million.

Our overall operating profit for the quarter was SEK 121 million, which is an increase of 17%. And our EBIT margin, as I said, was 27% for the quarter. In terms of our strategy, we have 3 strategic pillars. Our first is what we call grow the core, and these are our core health areas, of which gut health, colic is a part of that for infants, oral health and immune health are our 3 core health areas that we focus on through our marketing and commercial excellence.

Our second strategic area is what we call expansion through direct markets. So I'll talk about this a little bit in terms of how we have been expanding our business through new direct markets in 2025. And then our third strategic pillar is what we call breakthrough innovation.

So think about this as market creation opportunities for probiotics, where probiotics are not used regularly. And the foundations that underpin our strategy are, of course, our people and culture, investing for profitable growth, digital as an enabler of our business in terms of how we go to market with our omnichannel approach as well as digitizing our business internally for more productivity and efficiency.

One of our foundations, which has been a foundation for many years is driven by science. It's a key differentiator of who we are as a brand and in our products. And then finally, sustainable solutions, where we're focused on sustainability in multiple areas, packaging, raw materials and so forth.

How did we deliver on our strategy? So in terms of our first area, grow the core, we're driving growth, as you saw in both the Pediatric and Adult segments for the quarter as well as for the year. We're investing in marketing and selling activities to drive very strong growth in the direct markets.

And we are growing ahead in our direct markets, so strong double-digit growth versus our partner markets. We continue to roll out new products. So we launched a product called Gastrus Pure Action In the fourth quarter of 2024. And so in 2025, we continue to roll that out across a number of countries.

And I'm very happy to report that in Q4, this product really set a record. It is the third highest growth contributor in terms of SEK 1 million to our business. So it's doing extremely well in the markets where we've launched. And then finally, in Q3, we launched Prodentis Fresh Breath. We launched that in the U.S. market and have also been rolling that out in Q4 and we'll continue to do so in 2026.

So these 2 product launches have been very beneficial for us in terms of driving our growth, and we'll continue to roll them out in more markets in 2026. In terms of our second strategic area, expansion through direct markets, our direct market sales now in Q4 represent 40% of our sales.

And as I said, are growing ahead of our partner markets. So this has been a change over the last 2 years in terms of our sales used to be around 30%. Now it's 40% driven by our direct markets. We launched in France in 2025 and also the Netherlands.

So those 2 markets are doing well. France had a strong Q4 sales with record sales. Australia, we had launched in 2024, and that market, in particular, is doing very well for us. Our Protectis drops are now #1 in the market in Australia, whereas they previously were not with our previous partner.

And in 2025, we had record sales in our U.S. market, SEK 316 million, which this represents 30% organic growth. So very strong performance by our U.S. market as well as our Canadian market, also strong double-digit growth.

In the terms of breakthrough innovation, in 2025, we established a new subsidiary called BioGaia New Sciences with a strong focus on skin health. We have our probiotic ointment that we had launched and now is rolling out to more markets in 2025 and is also doing well where we launched it.

So this is our overall how we've delivered on our strategy in Q4 as well as in 2025. In terms of our product launches, as you can see, we had a lot of product launches in Q4. So this lists all the different countries where we have launched different products, whether it be Pharax drops, which is one of our immune health products, Prodentis Fresh Breath lozenges, as I mentioned, Gastrus products, Prodentis products, so various new launches across markets in Q4.

And as you see here, we've highlighted the markets where we rolled out Gastrus Pure Action, which I mentioned in Q4. Some of the key events that we have talked about in the quarter. In October, we announced a study on a new patented strain, which is called BG-R46, and that was published in a journal called Beneficial Microbes. Also in October, we talked about a study on a new bacteria for us that actually produces serotonin.

So this is a first for bacteria. So more to come on this. This is a preclinical discovery. So we'll be doing more work on this in the future. And as you know, serotonin dramatically affects the brain in terms of mood and overall well-being of mental health.

And then just recently, in February, we announced that our fourth quarter results exceeded our market expectations. And the Board is proposing an ordinary dividend according to our policy and also an extra dividend for a total dividend of SEK 4 per share.

And overall, when you look at the business for Q4, as I said, we had 32% overall organic growth in the quarter for Pediatrics, 34%, for Adult, 27%. So Pediatrics represents about 75% of our overall revenue. And in the quarter, we saw some significant increases for Protectis drops in China as well as France.

And also in the quarter for Adults, we saw some significant increases in Gastrus as well as Prodentis, mainly in the U.S.A. And in the chart, you can see our quarterly variations over the last 2 years. So you can see the various fluctuations. Sometimes we'll have more orders from partners in one quarter, less orders from partners in another quarter.

And in terms of our sales per segment, I mentioned Pediatric and Adult for the quarter. But overall for the year, we had organic growth in Pediatrics of 11% and 22% in Adult Health. So both of these areas growing very well overall for the quarter as well as for the year in 2025.

In terms of our regions, for Europe, Middle East, Africa in the quarter, we grew 34% and this is organic growth. And in terms of the year, we grew 1% in Europe, Middle East, Africa. A couple of comments here. For the quarter, we saw some increases in sales in France and Eastern Europe as well as in Italy.

But also overall for the year, we took our business direct starting in April. So in Q1, we did -- we had much lower orders from our partner and also we had a period of time where our partner sells through their inventory. So then it takes a while then for our sales in the direct market to build.

So that's also what impacted the overall year for EMEA as well as Germany. So we're now taking Germany direct. We've now launched that in Q1, Germany and Austria. So same thing in 2025, we see our distributor partner have less orders, so we have less overall sales, and then we start to see that pick up.

So we will see the continuing decline of those orders from our partner in the beginning part of this year, 2026, and then start to see the sales growth for Germany in the second half of 2026.

So for Asia Pacific, for the quarter, organic growth of 46%. Overall for the year, 19% organic growth, very strong for the quarter in China and the Philippines. We also had some quarterly variations for China in terms of orders in the quarter for Q4.

So overall, Asia Pac doing extremely well in terms of overall growth, strong performance, as I said, China, Philippines as well as Indonesia for the year. For the Americas, for the quarter, we saw 20% organic growth and overall for the year, 22% organic growth.

So in the Americas, as I said, U.S. is a standout market for us in terms of growth. So 30% overall organic growth for the year. In addition, we saw strong growth in Guatemala as well. And as we've discussed previously, especially in the U.S., we had increased our marketing investments to drive our overall brand awareness and equity and expand our market share, and we successfully did that in 2025.

So now I will turn it over to Alex to go through the financials in more detail.

Thank you, Theresa. So if we start to summarize, we had a sales growth, as we heard of 21% from SEK 365 million to SEK 441 million. And we had a growth in gross profit of 25% to a margin -- gross margin of 74% compared to 71% in the same quarter last year.

Our EBIT increased with 17%, and the EBIT margin was 27% versus 28% in the same quarter last year. As we heard, we had a total sales growth of 21%. However, we had considerable negative currency effects of minus 11%, so that our organic growth was 32% in the quarter. In terms of gross margins, we had an overall gross margin of 74% in the quarter compared to 71% 1 year ago.

If we look at the 2 segments, Pediatrics increased its margin from 72% last year to 76%. This is mainly due to mix effects, both geographic mix effects and some product effects and also that we have done some price increases continuously here.

And if we look at the Adult, we saw a slightly lower margin of 64% in the quarter versus 67%. This is really only related to some variation in some larger order mix effect that we had in the quarter. And as you can see for year-to-date, our Adult Health margin was 66% higher than in the quarter and also substantially higher than compared to the full year last year.

So for the full year, we had an increase of our gross margin to 73% versus 72% a year ago, driven both by increases in margin, both in Pediatrics and Adult Health. If we move on to the operating expenses. Our total expenses were SEK 203 million in the quarter versus SEK 155 million 1 year ago, which was an increase of 31%.

We didn't really have any adjustments in the quarter. However, we had it for the full year. For the sales and marketing, our costs increased 21%, basically in line with the sales increase. R&D costs increased 9%, administration, 8%. And then we had negative currency effects of SEK 6 million in the quarter.

If we look at the full year, we had a cost increase of 18%. However, there were some one-offs in the same last year -- in the previous year in 2024. We had a write-down of an impairment for the MetaboGen acquisition, which affected the R&D costs.

So if you normalize for that, our OpEx increased with 29%. For the full year, the sales and marketing also increased in line with what it did in the quarter, 21% and our administration costs increased 14% and we had considerable negative currency effects of SEK 40 million for the full year last year, which obviously affected our margin negatively.

And this is mainly an effect of the weakening dollar versus the Swedish crown (sic) [ krona ]. We move on to the next to summarize the profit and loss. We had a total sales of SEK 441 million, OpEx of SEK 203 million and an EBIT of SEK 121 million, which then was a margin of 27% versus 28% last year and an earnings per share of SEK 0.98 versus SEK 0.81.

And as we heard Theresa mentioned, for the full year, total sales of SEK 1.54 billion, an increase of 8% and an EBIT that was slightly lower, 3% lower due to the higher operating expenses and an EPS for the full year of SEK 3.29 versus SEK 3.48 last -- in the previous year.

In terms of our cash flow, we had a cash flow from operating activities before changes in working capital of SEK 109 million, an improvement of SEK 14 million. The changes in working capital were, however, in the quarter negative SEK 25 million compared to plus SEK 9 million in the same quarter last year.

This is mainly due to an increased number of receivables because we had a lot of sales in the later part of the quarter. So this will normalize in the first quarter this year. There is no one-off special effects.

It's more an effect of the fact that some of the sales came later in the quarter, for example, those orders that -- the one-off orders that we mentioned. Cash flow from operating activities then at SEK 84 million versus SEK 103 million in the same quarter last year. We had very, very low investment -- cash flow from investments in the quarter, basically 0.

Some cash flow from financing activities, minus SEK 7 million and a total cash flow in the period of SEK 77 million and the cash at the end of the period of SEK 800 million. And for the full year, we had a cash flow from operating activities of SEK 307 million, and we had a cash flow for the period of minus SEK 407 million, mainly then due to the negative cash flow from financing of the dividends, which were approximately SEK 700 million that we paid out last year.

So with that, I hand over to Theresa for some final remarks.

So overall, in summary, our organic sales for the fourth quarter grew 32%. As we said, we had some order variability as we often do in the fourth quarter, approximately SEK 35 million. Our Pediatric segment, very healthy growth of 34% in the quarter. And overall, as I said, Protectis drops increased across all of the regions and mainly in China and France saw some significant growth. And the Adult Health segment in the quarter grew a very healthy 27%.

So strong growth of Gastrus as well as Prodentis in the United States. All regions for the quarter delivered double-digit growth. All direct markets also delivered strong growth, as I mentioned. We, in 2025 as well as in Q4, invested in marketing activities to drive growth across our direct markets, specifically the U.S. is an area that we had strong investments in 2025.

We did see strong double-digit growth in the quarter as well as year-to-date in the U.S., driven by these investments in marketing activities. We also saw strong sales in Europe, Middle East, Africa for the quarter.

And as I explained, weaker sales overall for the full year, and this is due to establishing our direct markets of France and Germany. And overall, for the operating margin, 27% versus 28% last year for the quarter. So for the full year, we saw organic growth of 14%, 8% adjusted for currency.

As we discussed, we have successfully delivered on our strategy with growing our core business around oral health, gut health and immune health. We are expanding our direct markets, very successful in driving growth in those markets ahead of our partner markets.

And we've been successful in launching and rolling out new products across our global markets. And as I said, we have some particular very successful new products such as Gastrus Pure Action as well as now Prodentis Fresh Breath that we will continue to roll out in more markets in 2026.

And as we look towards 2026, we remain committed to our ambition of growing low double-digit growth in terms of our top line, and we have a long-term EBIT margin target of 34%. So based on revenue, controlling our costs, we will see margin expansion in 2026 that will guide us more toward not quite yet to that long-term goal for margin.

And we are proposing a Capital Markets Day in 2026. We have an annual strategy review process that we will be doing with our Board as we typically do each year. And then we will be doing a Capital Markets Day with more information to come on that later this year. So we open it up now to questions.

[Operator Instructions] The next question comes from Mattias Vadsten from SEB.

Can you hear me?

Yes.

I have a few. So first one, in terms of understanding the U.S. sales growth. So the 30% organic sales growth you had here in 2025, sort of what products are growing the most, would you say? And what sort of efforts from BioGaia has been central to achieve this impressive figure? That's the first question.

Yes. So in answer to that question, the products that are growing the most are Prodentis, so the adult oral health area. So Prodentis, we do a lot of activities with dentists and dental hygienists to build recommendations for our brand.

And then we see that strong growth through online channels. as well as last year, we got distribution for Prodentis in CVS, which is the #1 pharmacy chain in the United States. Most of our growth, I would say, is coming from online sales for Prodentis. So Prodentis is one of the winners.

Another one is Gastrus, our adult gut health area. So we've seen strong online sales for Gastrus as well as strong sales for our Protectis drops. And our Protectis drops, we have sales online on Amazon as well as other channels. But in addition, in 2025, we expanded distribution into Walmart. That's going extremely well. Walmart is very pleased with the growth and is now expanding our product into more stores in 2026. So those are the main products where we saw growth in the U.S.

And then I think you mentioned what share of sales was direct markets in 2025. If you could just remind me of that figure, I didn't.

Yes. So it's around 40% is now direct market sales.

In full year '25 or in Q4?

Both.

Okay. And then you focus on immune health, gut health, oral health, of course. And sort of could you -- you grew 14% on a group level for 2025. Could you just say, are you sort of satisfied with all of those 3 areas? Or could you expect better momentum in any of them if you follow what I mean.

I mean I would say we are very satisfied with growth across all of our sectors and extremely pleased with the gut health and the oral health areas. Those are the areas that are disproportionately growing for us across the world and also in very specific markets as well, such as I was talking about the U.S. with oral health, but also Canada with oral health, I would say, is another market, Japan as well as some of the other Asian markets.

Perfect. And then last one, if you see a more modest OpEx growth from Q1 onwards on a year-on-year basis, driven by...

So for 2026 -- I'm sorry, go ahead.

No, if you see that coming through and if you're also sort of looking at more modest U.S. investments? Or how do you view that? That was my last question.

Yes. Yes. So we look at -- for 2026, we'll be looking at controlling overall costs and OpEx so that we can drive our margin expansion with also strong revenue growth. And in the U.S., we will be spending less than we were previously in terms of our marketing expenditure.

We learn what channels have the highest ROI for us and then focus our marketing spend in those channels with those creative executions. So we will be continuing, of course, our always-on marketing spend in the U.S. and in other markets. And we just -- we have a lot of information now in terms of what drives the strongest ROI, and we'll continue focusing on those particular channels.

The next question comes from Mattias Haggblom from Handelsbanken.

So even if I adjust for the one-off order, organic growth was 22% in Q4 despite a very tough comparable last year. So help me understand what that suggests for the momentum in the business heading into 2026 because I guess the instinct is, of course, that we should think of this pull forward order as Q1 will then be weak as a consequence. But if I adjust for the order and you grow 22%, that tells me another story. So help me understand the dynamic of the 2.

Yes. So why we communicate some of the order variability is because we do see this sometimes in our quarters where some partners will order more in one quarter versus another. So we like to signal that.

So especially when we've had a strong quarter like Q4, so we make sure that estimates as we look at future quarters are appropriate. So we will continue overall as we look at growth, but not at the levels of our Q4 because we've had some orders that move in from Q1. Hopefully, that makes sense.

So maybe -- yes, sure. Absolutely. We welcome the disclosure. But I'm still trying to better then understand the 22% growth adjusting for the one-off order, which suggests that the business is having a very strong momentum. So maybe although with the risk of repeating ourselves, remind us, in particular, what drove that strong underlying growth even adjusting for the one-off order?

Yes, I can try to answer that. I mean, as you can see, we had exceptionally strong growth in mainly -- well, in APAC and in EMEA. And this is also those areas where we did have those exceptional orders, so to speak.

So -- but you can probably guess that, I mean, we would have a very strong growth even excluding that effect in EMEA, which is driven then by what we mentioned, the strong development in France, for example, where we have a strong development there and also some other EMEA markets performing a lot better, so to speak, which we saw sequentially last year during the quarter.

So actually, EMEA from being negative was less and less negative and then turned into growth now in the fourth quarter. So in EMEA, it's driven by an underlying improvement in several markets in EMEA. And then it was a continued very strong development in Asia Pacific, even excluding the Chinese variable variation in orders.

That's helpful. And then perhaps the German transition. So is it possible to help us understand the magnitude of that transition? Is it as large or smaller than the French transition? Just to understand the dynamic when you move from the distributor to direct sales?

Yes. It's a little bit smaller than France because France is one of our largest European markets. So it is smaller, but there still is an effect because in Germany, we've had strong sales, not just for our Protectis drops, but also for Prodentis. So there's that transition across both of those key areas.

That's helpful. And then in terms of capital allocation, I'm curious to understand, we get the extraordinary dividend, and we know the policy of 50% plus up to 100% extraordinary dividend. But we have a new chair, and we have a somewhat different shareholder cap table basically. So has the management team discussed alternative ways of distributing capital back to shareholders beyond the extraordinary dividend, including buybacks?

Yes. So we have the management team as well as the Board, we have discussed various ways to return value back to the shareholder, and we'll be having more discussions on this as we go through the year.

That's perfect. And my final one then is you spoke about the lessons learned in terms of marketing spend and what channels had in particular, best ROI. To the extent you can, can you share more color on where things work and where they work less so?

Yes, I can. So where they work better is when we use platforms to drive to our main sales channels such as Amazon. So there are some very specific advertising channels that you can use to drive consumers to specific points to purchase. So that works really well.

And so we tested a lot of different channels, but we've also tested different amounts of spend, different creative. Your creative is a big part of your ROI. So also, we look at things such as there's more branded created. There's more things such as what we call user-generated content. So videos and testimonials of consumers talking about our brands. So we do a nice mix between those in our markets. But specifically, those channels that are driving to where our product sells the most have been very successful for us.

The next question comes from Kristofer Liljeberg from Carnegie.

Yes. Coming back to this, the phasing effects and volatility in orders. So if you look at full year 2025, would you say that the total effect has been neutral, positive or negative?

I mean, I'd say overall kind of neutral, I guess, when you look maybe a little bit more. But if you look past at our quarters, we have some order variability. You can see that in terms of our overall business as well as our Pediatric and Adult business.

And if you look at the page earlier that we were sharing in the past quarters, sometimes our Pediatric business is a little bit different in terms of quarterly variations versus the Adult business. So overall, we will continue to see order variability because of our distribution network through our partners. As our direct market sales get to be a larger percentage, we'll see less of that order variability.

Okay. So even if you were growing 14% organically here for the full year, that shouldn't stop you from continue to grow double digits in 2026. And I'm thinking specifically here also as you will scale back a bit on U.S. marketing, which I think has boosted sales somewhat in 2025?

Yes. I mean our ambition is to continue to grow and to grow in the low double digits.

The next question comes from Mattias Haggblom from Handelsbanken.

We can't hear you. Is there a question?

Apologies for that. So a question on direct sales. You said it's up at 40%, growing faster than the rest of the group. Is it fair to assume that you anticipate direct sales to grow faster than the group also in 2026 based on what you know today?

Based on what we know today, yes. We anticipate that we will continue to see this, especially because we've just established our direct market in France, which is a large market for us in Europe as well as Australia is growing well, Canada, U.S., Finland. So a lot -- we have much higher growth in our direct markets, and we anticipate that to continue.

And the addition of Germany.

Yes.

And a follow-up to that then as my final question. Is there any ceiling in the business model? Or how do you think about these 2 different sources of sales for the company over time as it continues to march north as its growth faster, so to say. Where do you think things shakes out over time?

Yes. I would say we anticipate the percentage of our sales from direct markets to accelerate and grow higher because we have a lot of our larger markets now as direct markets. So that is what we anticipate. So that 40% will get larger over the coming years.

But our distributor partner model is a very important part of how we go to market. And we are in markets -- we're in over 100 markets globally. So we don't ever anticipate that we will take all of our markets direct. So there will be key strategic markets where we have our business as a subsidiary.

And in those markets, as you know, that's where we drive the marketing, the selling activities, the new product launches, all those aspects. So it's a very different setup for us versus working with a pharmaceutical company as a distributor partner. But we do, in answer to your question, we anticipate that percentage will continue to grow over the coming years.

The next question comes from Mattias Vadsten from SEB.

Just 2 follow-up questions, if that's okay. First one, I remember in Q3, we talked about a slow Eastern Europe development, and it sounded like you had a big distributor there covering, I don't know, if I remember, 14 or 16 markets. So just what happened there? And if that has coming back as you expected and if it's sort of good momentum in that region?

Yes. So in terms of Eastern Europe, we had a very strong 2024 across those markets. And then in 2025, we saw a little more softness in certain markets. Poland, which is the largest of those markets. And as you said, it's about 16 markets across Central Eastern Europe. Poland is really coming back nicely.

And our partner has invested more in terms of selling and marketing activities in that market. So we anticipate Poland, a really good growth market for us for the future and one of the top probiotics markets globally. Some of the other markets are much smaller in terms of size. And so -- but we anticipate solid growth in those areas.

That's very clear. And then on the U.S., you say 30% growth for the full year. I don't remember -- last quarter, we talked about some 25% year-to-date. So if you're willing to give any color on how Q4 organic growth looked like in the U.S. That's my last question.

Yes. We haven't given information specifically on the quarter-by-quarter. So we will report the U.S. on an annual basis more. But we've had some really nice consistent growth in the U.S. in the strong double digits really throughout 2025.

[Operator Instructions] There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

So this is Theresa. Thank you so much for your questions and for listening for our Q4 results, and we will then be presenting later this year on Q1. So thank you so much.

Welcome to BioGaia Q3 Report for 2025. [Operator Instructions] Now I will hand the conference over to CEO, Theresa Agnew; and CFO, Alexander Kotsinas. Please go ahead.

Hi. This is Theresa Agnew, CEO of BioGaia, and Alex and I are here to present our Q3 results. So sales were SEK 327 million, which is an increase of 7% due to higher sales in Americas as well as Asia Pacific. Growth overall was 14% when excluding currency effects. Year-to-date, our growth is 8%, excluding currency effects and 4%, including currency. Our sales in Asia Pacific for the quarter increased by 17% and Americas increased by 10% and in EMEA decreased by 4%, primarily due to sales in Eastern Europe. We saw strong growth following increased media investments in the U.S. and other prioritized direct markets such as Canada, the U.K. and Australia. With our increased media, we've been attracting new consumers to the brand and enhancing our brand awareness. For the quarter, our EBIT is SEK 86 million, and our EBIT margin is 26%. And as you can see, this compares to 14% EBIT margin last year. This was lower due to the MetaboGen impairment loss of SEK 51 million. Our year-to-date EBIT margin is now 27%.

Just to remind you of our BioGaia company strategy, we have 3 strategic pillars. The first is Grow the Core, in which we focus on gut health, colic, oral health as well as immune health. Our second is Expansion Through Direct Markets. And our third is Breakthrough Innovation. So this is where there are market creation opportunities for using probiotics in new areas. The foundations of our company are, of course, our people and culture, investing for profitable growth, digital as an enabler of our business as well as our go-to-market, driven by science, which has been a foundation for over 30 years for the company and sustainable solutions with a strong focus on sustainability.

We are delivering on our strategy. In terms of our Grow the Core, we're driving growth of our pediatric and adult segments. We're investing in marketing and selling activities to drive strong growth in our direct markets, as I mentioned, such as in the U.S. We're successfully launching new products in our core health areas. Last year, we launched BioGaia Gastrus Pure Action. And this quarter, we're rolling it out to more markets. This quarter, we also launched Prodentis Fresh Breath, which is a new product that combines our probiotics with zinc. So it works on gums, teeth as well as giving you fresh breath. We're rolling out many of our other products in partner markets and direct markets as well.

In terms of our second strategy, Expansion Through Direct Markets, we launched France as a direct market in Q2, and that market is starting to do well in Q3. We're preparing to launch Germany and Austria in early 2026. And actually, in Q3, France had its strongest month with record sales in September. So we have a high ambition in France to continue our growth into next year. Australia, which we launched in 2024, now with all of our marketing and selling efforts, BioGaia Protectis drops is now #1 in the market. We also have record sales in the U.S. market due to the investments that we've been putting into that market and our direct markets are growing ahead of our partner markets.

In terms of our third strategic area, Breakthrough Innovation, as you may have seen in the press release, we've established a new subsidiary called BioGaia New Sciences that will focus on skin health, which is a new breakthrough innovation area for us. And we are rolling out our BioGaia probiotic ointment to more markets. So now you will see we have new launches of our probiotic ointment.

So speaking of launches, this shows you all the launches we have had of products as we expand our new products into more markets for the quarter. So we have rolled out our probiotic ointment in Sweden, Finland and the U.K. We launched Prodentis Fresh Breath lozenges, as I mentioned, in the U.S. In Argentina, we rolled out a number of our products. Slovakia. And in the U.S., we launched our BioGaia Gastrus Pure Action capsules that we had launched in Finland for the first time last year. And then also in Australia and New Zealand, we also rolled out Gastrus Pure Action capsules.

All of these launches are doing very well, especially Gastrus Pure Action is driving increased sales in our adult gut health area as well, it's continuing to do extremely well in Finland after a year of launch without cannibalizing our chewable Gastrus product.

Some of the key events that happened during the quarter. As I said, we launched our BioGaia New Sciences subsidiary. At an extraordinary general meeting in August, we resolved to elect Mauricio Graber as our new Chairman of the Board. Also, Mauricio entered into an agreement to purchase some Class B shares from the anchor shareholder, Anatom Holding. BioGaia also announced distribution in Germany and Austria for the future. So we will be starting that in early 2026. We also announced the launch of a new product, Prodentis Fresh Breath. And as I said, that launched first in the U.S. in the quarter. And more recently, we announced the publication of a study on our new patented strain, L. reuteri BG-R46. This has actually been published in a journal called Beneficial Microbes. And we also introduced a press release on this, talking about how, as expected, this new strain, it's a new patented strain is safe and well characterized.

In terms of sales per segment, so in our Pediatrics area in the quarter grew by 7%. And if you exclude currency effects, it's 14%. This is mainly due to increased sales of Protectis drops in Asia Pacific, Latin America, specifically some markets that did very well were Indonesia, Vietnam and Mexico.

In terms of Adult Health, our sales increased by 6% in the quarter, increasing 13%, excluding currency effects. We saw particularly strong growth of BioGaia Gastrus in the U.S. and BioGaia Prodentis mainly in the U.S. as well. And as you can see, our Pediatrics business remains at about 75% of our sales.

In terms of the regions, as I said earlier, EMEA sales decreased by 4%. This was mainly due to Eastern Europe and Italy. But one comment on Italy. Italy is growing well for us this year. So the decline that we saw was mainly due to order variability because we saw higher orders in Q2.

In France, as I said, we achieved record sales in September. We're driving increased distribution. We're driving recommendations through pharmacies. So we anticipate that this will continue.

And in Turkey, we have signed a long-term distribution agreement with one of our partners, Abbott. Abbott is actually a long-standing BioGaia partner. We partner with them in the Middle East, in Latin America, some other Asia Pacific markets. So we have now signed an agreement with Abbott Turkey or the market of Turkey.

So in Asia Pacific, our sales increased by 17%. This was mainly seen in Vietnam, Australia as well as Indonesia. And specifically in Australia, one of our direct markets, we are expanding distribution. We're increasing our marketing activities, and we're growing market share in the market.

In the Americas, our sales increased by 10%. This was mainly due to the U.S. and Mexico growth. And in particular, on the U.S., we're achieving record-breaking sales in the quarter. We successfully launched the 2 new products, as I said, which is BioGaia Gastrus Pure Action capsules and the BioGaia Prodentis Fresh Breath. Both products are getting off to a fast start in the U.S.

So I will now turn it over to Alex to go through our financials in more detail.

Thank you, Theresa. So if we just summarize the key financials, we see that our sales grew 7% from SEK 304 million to SEK 327 million. Our gross profit grew 9% and our EBIT grew 108% from SEK 41 million to SEK 86 million and a margin of 26% in the quarter versus 14% in the same quarter last year.

If we look at the sales, as we heard previously, we had a sales growth of 7%. However, excluding currency effects, we had an organic growth of 14%. The gross margin improved from 73% last year to 74% this year, mainly due to an improved margin in Pediatrics, which is the largest segment, but also an improvement in the Adult Health. And if we just -- the main explanation for the improved margin is mainly different geographical sales compared to a year ago, more favorable geographic shift, for example, in direct markets, where we do have a higher gross margin, but also partly due to some price improvements, price increases, which we have done during last year, which are obviously impacting the margin positively. And year-to-date, then we have a gross margin, which is flat compared to a year ago, down 1% in Pediatrics, however, up 6% in Adult Health.

Move on to our expenses. Our total expenses were SEK 157 million in the quarter, which is then 13% lower compared to 1 year ago. If we look at the different lines, sales and marketing cost at SEK 116 million versus SEK 96 million last year. That's an increase of 21%. This is an effect of increased sales and marketing activities, mainly in our subsidiaries and then mainly, of course, in North America and the U.S., where we have the largest operations. And that is why the sales and marketing costs have increased due to those increased investments.

In terms of R&D, R&D costs decreased to SEK 26 million due to the -- as Theresa mentioned previously, due to the MetaboGen impairment loss, which we took in the same quarter last year. And excluding that, we had a growth in R&D spending in the quarter.

Administration costs at SEK 11 million, an increase of SEK 18 million. There are some start-up related costs to going direct, which are included in this line. But other than that, it's basically the same costs.

And then we have other OpEx, which is basically exchange losses on receivables at a cost of SEK 4 million in the quarter and also worth to note that it's substantial cost in year-to-date of SEK 33 million.

We move on to the next, the profit and loss, just to summarize, our sales grew 7%. Our costs grew 13% and therefore, our EBIT -- the adjusted EBIT declined 8%. And the adjustment again was this impairment loss 1 year ago.

To move on to the cash flow. The cash flow from operating activities increased by SEK 10 million to SEK 110 million due to -- mainly due to a positive change in working capital. And the positive change in working capital is related to lower receivables. We had quite high sales in the second quarter this year, and a lot of those payments came in the third quarter. So the receivables decreased with SEK 49 million. We had higher payables of SEK 2 million, and this was offset by higher inventory of SEK 10 million. All of these variations are basically normal variations that we have. There's nothing -- no one-offs or anything like that. And that leads to a cash flow for the period of SEK 107 million versus SEK 111 million last year. So basically a flat cash flow and a cash at the end of the period of SEK 728 million versus SEK 1.11 billion in the same quarter last year.

So with that, I hand over to Theresa for some concluding remarks.

So in summary, as we said in the third quarter, our overall organic growth was 14% and an overall increase of 7%. And if you look year-to-date, we also grew 8% organically and up 4% with the currency effects. In the Pediatric segment, we grew 7% in the quarter, 14%, excluding the foreign currency effects. Strong growth of BioGaia Protectis drops, as I said, in Asia Pacific and Latin America. The Adult Health segment is growing nicely for us, 13% organically and 6% including exchange effects. Year-to-date, 16% as well as 20%, excluding the currency exchange effects. So we're seeing particularly strong growth of our BioGaia Gastrus product line, which falls into our adult gut health segment as well as the BioGaia Prodentis, which falls into our oral health segment in the U.S.

In Americas and Asia Pacific, those 2 regions both delivered double-digit growth. Sales in EMEA declined slightly compared to the same quarter last year. And as we said, that was primarily driven by weaker performance in Eastern Europe. We are investing in marketing and selling activities this year to drive strong growth in our direct markets. We have seen a nice result of that with strong double-digit growth in the quarter and year-to-date in the U.S. Some of this is obviously offset by currency effects as well as lower sales in EMEA due to certain partners. And when we take markets direct, what we typically see is we see lower sales upfront when we're establishing the direct markets because our partners are typically selling through their prior inventory. So as we are establishing these direct markets in France and Germany, we'll see some lower sales and then that will then pick up once the prior inventory is sold through. So the strong double-digit growth in the markets where we're investing is offset by these things.

Our adjusted operating margin of 26% for the quarter and then 27% year-to-date. As we said, we also had an extraordinary general meeting to elect Mauricio as our new Chairman.

So we will now turn it over for any questions that you may have.

[Operator Instructions] The next question comes from Kristofer Liljeberg from DNB Carnegie.

It's good to hear that direct sales seems to do well. Is it possible to give a figure for how large share of total sales that now represent? That's my first question.

The second question is on the extra marketing investment, is it possible to quantify how that has impacted sales? You're talking about good momentum in the U.S., but maybe if you could quantify that.

And then when it comes to the reason for weakness in Eastern Europe, anything particular there? If I remember correctly, you have one large distributor. So I don't know if it's some destocking, stocking effects impacting there as well.

Yes. So the first question around what percentage of our sales the direct markets now represent, that's approximately 36% of our overall sales. And frankly, we anticipate that to continue to grow because as we grow the business in France and then Germany and Austria next year, it will get to be a bigger percentage of our sales.

In terms of our marketing investment, to quantify that more, the majority of our investment by far is in the U.S. We also have made some smaller investments in the U.K., Canada and Australia. But the U.S. business is doing extremely well. So over 20% growth in the U.S. So very strong results from our investments around marketing and media.

In terms of Eastern Europe, you're right, we have...

Sorry, before Eastern Europe, could I just follow up on these 2? So the 20% growth in the U.S., I guess that's currency adjusted. Is that in the quarter or year-to-date?

So that's overall year-to-date. We look -- that's what I'm quoting is more year-to-date. But similar also in the quarter itself.

Okay. That's very helpful. And just on the first one, the 36% overall or 36% share of direct sales, is that in the quarter or last month? Or how would you...

That's in the quarter.

Perfect. And then my final question, sorry.

Yes. And then in Eastern Europe, you are right, we have one partner, Ewopharma that covers about 16 markets across Eastern Europe. And there is some order variability that is happening there. So we anticipate that there will be increased orders and there's transferability from one quarter to the other in terms of those markets.

The next question comes from Mattias Vadsten from SEB.

First one, I was curious to hear a bit more on EMEA. So maybe if you could quantify what impact the transition to own sales had in Q3 year-over-year on growth? And yes, is that a reason at all for EMEA declining here? And also, if you can talk about the impact this could have on organic growth also for the coming quarters? And if you see sort of EMEA returning to growth near term based on order variability in Eastern Europe? That's the first one.

Yes. So in terms of own sales in EMEA, because we have taken France direct, we have seen year-to-date a decline in sales because our partner has been then selling through their inventory. So not ordering from us and also selling through their inventory. So we started selling in Q2, but in very small amounts. So now we're starting to see that pick up as expected. So whenever we take a market direct, we anticipate that there will be lower sales for a period of time, and then it will start to grow as inventory is sold through in the market, okay?

So that is the own market, the own sales is a reason for decline in EMEA around France. And France is a very big market for us in the EMEA. So that, of course, can be offset by some of the other markets, but they're much smaller. So Finland as an own market is growing really well. U.K. as an own market is growing double digits. But because France is such a large market for us in Europe, it offsets those.

That was what I thought as well. And in terms -- when it comes to Germany and Austria, could you just elaborate how we should see that transition, sort of how it looked in Q3 and how sales will look in those markets?

Yes. So good question. So we will see a similar effect with Germany and Austria, where we will see some declining orders in terms of the partner ordering from us, and they will be selling through their inventory into next year. So we will be able to start selling. And so just like France, we'll see a period of time where we will start to increase sales in early next year and then see more benefit in the second half.

Perfect. Would you say this effect was already there in Q3?

I'm sorry? Yes.

Okay. So that was there in Q3.

Yes. Yes.

Okay. That all makes sense. And then -- Yes. In terms of OpEx, so it has been up some, I guess, with some variability, but sort of 20% for the 4 past quarters now. So I'm just looking ahead, Q4 last year, you had a quite steep OpEx increase. So yes, do you see the growth in OpEx coming down a little bit in the quarters ahead? Or how should we see that?

Yes. So the OpEx, I think in the fourth quarter, normally, we have seasonal effects, whereby we have some seasonally increased OpEx in the fourth quarter, for example, in the U.S. market. So without providing any guidance, I mean, our costs -- normally, they will go up somewhat in the fourth quarter.

Perfect. Then I have one final question, if that's okay. The new patented strain that you bring up in the presentation, BG-R46, if you could just talk a bit in general about this and maybe how it will be included in your sort of broad product offering that you have today? And then maybe potential combination with DSM 17938 in colic drops for infants? Yes, a general run-through of how you see that strain being included in the offering.

Yes. So BG-R46 is an important strain for us for the future. So it is a patented strain that we will include in new products. So we have talked before about how we look to launch a new product that will be a combination product of our DSM 17938 strain and our new patented strain. So this is the new patented strain that would then be in combination with our DSM 17 strain in new products. And so we will have more information out on that in the near future. We are conducting a clinical study on a new drops product. So more to come on that when we get our results in. But we will be including this strain in multiple new products across what we call our Grow the Core. So it will be in colic-oriented products. It will be in other categories as well, immune health, gut health and so forth.

The next question comes from Mattias Haggblom from Handelsbanken.

I have 2 questions, please. So firstly, with a new Chairman as well as a new principal shareholder, I'm curious to hear how the Board's work has changed, if at all? Is there, for example, a strategic review plan together with the Board to reinsure all interests are aligned with regards to the path ahead?

And then secondly, sort of related to this, I guess we're in the mid of budget planning heading into '26. So with OpEx up 29% year-to-date, investor feedback suggests this remains a focus area. So at least help me think about the pace of OpEx going into 2026, at least directionally.

Okay. So in terms of the Board, so with Mauricio as our new Chairman, we have had 2 Board meetings where we have talked about numerous things. We have also updated on our strategic plan. So that has been included in terms of all of our discussions with our new Chairman. We will be doing as a typical part of our process, a strategic review in terms of our strategic plan with the Board upcoming. So that's a normal part of how we operate. But Mauricio has now been involved in 2 Board meetings thus far since August.

And then if Alex wants to talk a little bit about OpEx, I think you had a question on the OpEx.

Yes. So basically, I mean we do have this ambition, of course. Our financial target is to have a 34% margin, and we are not there at the moment. And our ambition is to improve this going forward. We will improve our EBIT margin basically going forward without specifying exactly when, but that is our ambition for next year. So basically, that our OpEx will be -- will not grow to the same extent as our gross profit will grow. It will grow to a lesser extent.

And also just to add to that, as you know, with our direct markets, we have a level of investment that we do with the direct markets. We run a very lean organization. So we don't have a lot of fixed costs, but we are making investments in those direct markets of France as well as Germany.

I have one follow-up. So if OpEx is up 29% year-to-date and sales in the U.S. is up over 20%, where majority of the investments have been targeted, how do investors build confidence that these investments actually do generate and translate into a good return?

Yes. So in terms of the future growth, what we can see is -- so some of the things that we've talked about in terms of direct markets, so France and Germany, for instance, we have a lot of confidence in terms of how we will grow in those markets for the future. So France is an extremely important European market for us. And frankly, Germany, we anticipate that we will grow our business substantially there because in the past, it has been smaller of the European businesses for us. So we want to really focus in that market as well. So if you look at where we're investing, we anticipate seeing the growth in those markets where we are investing, France, Germany, U.S., Canada.

I think everyone is aligned that these direct -- go direct to market initiatives have worked favorably. I think if there is a debate, it's more around the more short-term campaign investments, so to say. So I heard you say the majority of investment this year has been for the U.S., and U.S. is up less than the OpEx for the group year-to-date. So is there any way you can share your confidence that these more campaign-related investments as well translate into permanent good returns?

Yes. Yes. And they are translating into good returns for us in the U.S. So if you look at our spending in the U.S., we are driving considerable growth, as I said, over 20%. So -- but there's also currency impacts in terms of the U.S. dollar.

Okay. So the 20% includes the headwind from FX. So in local currency, the growth year-to-date in the U.S. may be even higher than 10%. Is that how I...

That's correct...

[Operator Instructions] The next question comes from Kristofer Liljeberg from DNB Carnegie.

2 follow-up questions for me. I think you said that France had a record month in September. Is that also compared with the previous distributor sales in a given month?

We don't track it by the previous distributors' sales in a given month. We don't have all of that information from our distributors, but just in terms of our sales in the French market.

Okay. But I mean, is this since you started to sell directly or shipments or sales you have booked to distributor previously in a given month as well?

Yes, yes. So it's versus our sales to the distributor in a particular month. So we don't always get all of the sell-out information and what the sales is in market from our partners.

Yes. But that sounds very positive given that there must have been some months where they have had -- where the previous distributors has built inventory, et cetera.

Yes. Yes, it is very positive for us. And also with our taking this market direct, we now have a broader opportunity for distribution. We're still working on this. But the sales force that we have hired actually has access to even more distribution points than our previous partner. So that's one of our goals is to drive our distribution further.

Great. And then nice to see the Pediatric margin improving in the quarter. And I think, Alex, you mentioned some price adjustments, et cetera. So it sounds this should be a sustainable level or were there some very positive mix also in the quarter that explain this?

Yes, it's always difficult to know exactly. But I mean, we hope it's fairly sustainable, yes, unless there are some negative surprises, but it should be sustainable.

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

Thank you for your questions, and we appreciate the time to review our Q3 results, and we will speak with you again for next quarter. Thank you.