BioGaia AB (publ) (STO:BIOG.B)
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Earnings Call: Q3 2024

Oct 22, 2024

Theresa Agnew
CEO, BioGaia

This is Theresa Agnew, CEO of BioGaia. I want to do an overview of our results for Q3. First off, our sales were SEK 304 million, which was a decline of 4%, mainly due to weaker sales in EMEA, as well as some order variability, where we had higher orders in Q2 in certain markets. Sales in Europe, Middle East, Africa decreased by 27%, and in Asia Pacific, sales increased by 24%. I n the Americas, we had an increase of 5%. G ood growth in Asia Pacific and also solid growth in the Americas. Our EBIT was SEK 41 million, which was a decline of 65%. This was primarily due to an impairment loss that we had, which I will talk about. Our EBIT margin, because of that was 14%.

Without the impairment loss, if you look at the adjusted EBIT margin, it was 31%, and the adjusted EBIT was SEK 93 million or a decline of 22%. T here were items that affected the comparability in the quarter. It was primarily an impairment loss attributed to our MetaboGen acquisition, and that impairment loss was SEK 51.2 million . I will talk a little bit about the clinical study that we had been doing with prediabetes patients. I n terms of our launches, we had a number of launches, Pharax drops in Switzerland, [audio distortion] in Brazil, Protectis drops with vitamin D in Mexico, Prodentis lozenges in a number of markets in Latin America, as well as Protectis tablets with vitamin D in Peru.

In addition to other key events, we announced in July our exclusive distribution agreement with Recordati in Italy. Recordati, as you may know from previous, was a sub-distributor that is now our exclusive distributor in Italy. On October 17th, we also announced preliminary results that we would not meet market expectations. We had the impairment loss for the MetaboGen acquisition of SEK 51.2 million. This was due to a clinical study that had been going on for a number of years, where the primary endpoint for a potential product was not met. This was a product around metabolic syndrome, so it was a clinical study with about 108 patients looking at glucose values over a 12-week period for people with prediabetes, to see if glucose levels would decline with the probiotic versus the placebo.

Unfortunately, we did not see the primary endpoint of reduction in glucose. We did have a secondary endpoint where we saw improvement in triglycerides, but our primary endpoints were not met. In terms of sales, as I said, we had an overall 4% decline for the quarter. Our pediatric sales decreased by 12%, mainly due to Protectis drops. T his was mainly in EMEA, and in the Americas, it was more Brazil with the order phasing, because we had a very high Q2 and then a lower Q3. Sales decreased in Turkey and Spain. Spain was another example where we had higher orders in Q2 and lower orders in Q3. For the adult sales portfolio, increased by 29%, mainly due to Prodentis and Protectis tablets.

Our sales also increased in U.S. as well as in Korea, and Protectis tablets increased mainly in Indonesia and Hong Kong. A s you see from a year-to-date standpoint, our pediatrics business is growing 4% and our adult business is growing 16%, o verall growth of 6%. O ur pediatric business remained at around 78% of our overall sales. In terms of the regions I mentioned, the EMEA sales decreased by 27%. That was mainly due to Turkey, Spain, and Poland. In Asia Pacific, we had a healthy increase of 24%, mainly in Indonesia, China, and Australia. Australia is one of our direct businesses that we just took direct, actually in Q3. W e have a promising start in both Australia and New Zealand.

Our China business is doing very well, where we had higher orders in Q2 and now again, higher orders in Q3, so very strong growth in China. In the Americas, our sales increased by 5%, mainly driven by the U.S., Canada, and Guatemala. I'm proud to say in the U.S. and Canada, our business is growing very healthy, ahead of market. A s you see here then on the chart, year to date, EMEA is declining 2%. Asia Pacific is growing 25%, and the Americas is growing 4%. I t's good to see that our growth in the U.S. is strong, even though we're still lapping the Gerber sales from last year, where they stopped selling our probiotic drops last year. N ow I'll turn it over to Alex to go through the financials in more detail.

Alexander Kotsinas
CFO, BioGaia

Thank you, Theresa. T o summarize the third quarter financials, we had revenues of 304 million, which was a 4% decline. Our operating profit was 41 million, which was a 65% decline and our reported EBIT margin was 14%. Now, of course we had this adjustment, so excluding the impairment loss, we had an EBIT of SEK 93 million and an adjusted EBIT margin of 31%. Earnings per share were SEK 0.36 , and cash flow was SEK 111 million . If we look at the third quarter then, of the decline of 4% in the quarter, approximately 3% was due to currency and organically, we had a decline of 1.5%.

Year to date, we had an increase of 6%, of which organically, 7% increase and a currency negative currency effect of about 1%. If we look at the gross margin for the quarter, we had a gross margin of 73% versus 74% in the same quarter last year. In pediatrics, our margin was stable at 75%, and in adults, the margin was slightly lower at 66% versus 68% one year ago. The main reason for the lower adult margin is mix effects. For example, a larger proportional sales of Prodentis, where we have a slightly lower margin, and also due to some increased sales in certain markets, s o mix effects is the explanation.

If you look year to date, we can see that in total, we have a stable gross margin of 73%, which is the same as we had one year ago for the same period one year ago. If we move on to the operating expenses, our operating expenses increased with 56%. Again, this is due to that impairment loss. I f we exclude that, we had an increase of operating expenses of 11%. If you look at the line items, sales and marketing costs increased due to increased activities related to sales and marketing. This is an effect of going direct. B asically, when we have increased activity levels in the direct markets, our cost will increase there, and therefore, sales and marketing costs have increased.

That is the main explanation, that we do a larger proportion of our sales direct through our own subsidiaries. T herefore, those costs increase. In terms of the R&D, it's the impairment loss that is affecting the increase. If you exclude the impairment loss of SEK 51 million, the R&D costs are basically flat. Other OpEx was SEK -5 million. This is due to exchange losses and in the same quarter last year, it was a slightly positive effect there. Then in terms of admin costs, they are somewhat higher in the quarter, but in line with or actually lower than last year, year to date. All in all, then we have a total OpEx, which increased with 11% on an adjusted basis.

If we move on to the P&L then, to summarize, sales decreased with 4%, OpEx increased with 56%, and we have an EBIT margin of 14%. On an adjusted basis, as I mentioned before, we have an EBIT margin of 31% versus 38% one year ago. Year to date, our adjusted EBIT margin is 35% versus 36% one year ago. 35% is then above our financial target year to date. If we look at then, to summarize, the cash flow, so cash flow from operating activities increased with 1% despite the lower operating profit. T hat is due to that we have changes in working capital, which are only SEK -4.4 million versus SEK -23 million one year ago.

Cash flow from operating activities then is actually one million higher than last year, even though we have a lower operating profit. Cash flow from investing activity is very low, SEK -3 million in the quarter. Cash flow from financing activities is actually a positive 14, due to new share issues of about 20 million, which are included in that line item. Those new share issues are due to the incentive program from 2021. All in all, we have a cash flow of SEK 111 million versus SEK 88 million one year ago, and the cash at the end of the period is SEK 1.115 billion . With that, I hand over to Theresa for some concluding remarks.

Theresa Agnew
CEO, BioGaia

Yes. O verall, as we said, our net sales decreased by 4%, and it was a decrease of 2%, excluding the currency effects. Our direct markets are performing strongly across really all of our direct markets, but we have a very strong start in Australia and New Zealand. Our EMEA sales decreased by 27%, mainly due to lower sales in the pediatric segment and primarily in markets such as Turkey, Spain, and Poland. In Asia Pacific, we continue our strong growth with 24%, which was due to higher sales in both the pediatrics and the adult segment. M ainly, we saw that in China, Indonesia, and Australia. In Americas, our sales increased modestly by 5%, mainly due to increased sales in the adult segment. W e've seen that growth in Prodentis, Protectis, as well as Gastrus.

Sales mainly increased in BioGaia U.S., Canada, as well as Guatemala. In the quarter, as we said, we recorded an impairment loss, which is attributed to our MetaboGen acquisition, of 51.2 million SEK. Our operating expenses increased by 56%. I f you exclude those items, it increased by 11%. Our EBIT margin was 14%, and the adjusted margin was 31%. We will continue the ramp-up of our investments to drive our continued growth. We have investments also in Q4, that we are primarily focusing around sales and marketing in our direct markets. I open it up for questions.

Operator

If you wish to ask a question, please dial pound key, five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key, six on your telephone keypad. The next question comes from Mattias Vadsten from SEB. Please go ahead.

Mattias Vadsten
Analyst, SEB

Yes. H ello, thanks for taking my questions. First one relates to EMEA. Italy seems to be quite challenging. I s it worthwhile trying to enter with your own brand there to build a sort of strong market long term? Because I understand it is a quite large market overall, or what makes you sort of confident in the setup that you have right now? That's the first one.

Theresa Agnew
CEO, BioGaia

Okay. I n terms of confidence in the setup, so we have a very strong partner, Recordati. They are a top pharmaceutical company in Italy. W e just have transitioned over to them as our primary distributor, s o they are ramping up their efforts, ramping up their sales and marketing activities. W e are helping them quite substantially in terms of training their sales organizations on our science, meeting with key opinion leaders, meeting with healthcare professionals about our brand, our proprietary strains. W e are confident in working with our new distributor partner, that we will be able to drive growth in the Italian market. In terms of our own brand, it's not something we're exploring right now. We have an exclusive distribution agreement with our partner, which is under a different brand. It is under the Reuflor brand.

Mattias Vadsten
Analyst, SEB

Okay. T hen also on EMEA, I think it has not been satisfactory growth rates in this market recently, let's say, five, six years. M aybe we could talk a little bit about the visibility in turning this market back into growth mode, sort of where you see untapped growth potential in EMEA as it stands right now, and maybe which countries in that respect that would be highlighted.

Theresa Agnew
CEO, BioGaia

Yes.

Mattias Vadsten
Analyst, SEB

That's the second one.

Theresa Agnew
CEO, BioGaia

Yes, good question. In terms of the future where we see growth, there are some markets where our business is smaller, where we think there is upside in terms of the categories. M arkets like Germany, for instance, where what we tend to see is order variability with our distribution partner in Germany, but we're working with them on driving continuous growth in that market. We see a lot of penetration opportunity, as well as our direct business, the U.K. There is considerable upside in the U.K. We actually just got broad distribution of our Protectis drops in Q3. Boots, which is the largest pharmacy chain in the U.K., is very happy with the performance since we entered into their distribution in January of earlier this year.

N ow they've expanded our Protectis drops to 1,200 stores. We also just got in our Protectis chewables into Boots in almost 600 stores, and also our Prodentis product in Boots stores in also almost 600 stores. W e see a big opportunity in the U.K. Our Amazon business is growing strong. Our Boots distribution is new, and we have a lot of opportunity there, as well as in the independent pharmacy channel, where we ship to wholesalers. W e see a lot of opportunity in the U.K. as well. I would also mention that we also see opportunity in France, because 2023 was a lower year than previously. W e see opportunity for growth next year with continued focus, continued marketing activities.

We just launched our vitamin D drops in France, so that was a first, where we'd only had our original Protectis drops. Now we have Protectis plus vitamin D, so we'll see how that goes in the French market, but it is quite successful in other European markets, as well as markets in the Americas. W e're focusing on the markets where we feel we have a lot of opportunity for growth, and the larger markets like Italy, France, Germany, U.K.

Mattias Vadsten
Analyst, SEB

Thanks so much for that. I will have a last question, then jump back to the queue I think. T urning to OpEx, where you communicated this 75 million-35 million higher OpEx in the second half, n ow I think OpEx was up by a quite small amount, as you mentioned in the presentation. T wo questions, d o you see that at a smaller amount now for the second half? A lso, do you expect it to spill over to 2025 as it stands right now? That's my last one.

Theresa Agnew
CEO, BioGaia

Yes. W e did see some lower costs in Q3, but we also had some savings elsewhere in our portfolio. Where we are making investments is in our direct businesses, and we're making investments in sales and marketing activities, which will continue to Q4. What we'll do is, we are looking at the ROI of our investments. W e won't say right now what will continue into 2025 because we have to analyze, and we have to look at the return on the investment and then make decisions around what we will be continuing.

Right now, we are working on our global marketing campaign, which I've mentioned previously. W e will be investing in that, which is an exciting opportunity to do more advertising in some of our direct businesses to drive more brand awareness and brand consideration, and hence more penetration on our Protectis drops.

Thank you.

Operator

The next question comes from Kristofer Liljeberg from Carnegie Investment Bank. Please go ahead.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Hi, thank you. G ood morning. Some questions also focused on EMEA. F irst, you mentioned Poland here. Is that phasing effects or some underlying weakness?

Theresa Agnew
CEO, BioGaia

That was phasing effects. W e had a very high Q2, so that was phasing for Q3. O verall, for the year, Poland is strongly performing.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay, good to hear that. T hen coming back to Italy, when do you think realistically that you will be back growing sales in Italy again?

Theresa Agnew
CEO, BioGaia

It will take time, because we're training their sales force. They're going out more broadly to the medical community in terms of pediatricians, gastroenterologists, key opinion leaders. T hat will take time. I mean, I can't forecast a particular quarter, but we are starting to make some headway. W e do have a very strong brand. Reuflor is a dominant brand in Italy. We would just want to continue to drive the growth.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay, b ut do you think you will grow Italy again in 2025?

Theresa Agnew
CEO, BioGaia

Yes, we do think we will grow Italy again in 2025.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay. T hen I wonder about the situation in Turkey. I could understand your comment there about the demand, but it was something you wrote in the report that strike me that, I think you said that inflation impacted the distributor's business operations. Does your distributor have some problem there also impacting this more than underlying demand?

Theresa Agnew
CEO, BioGaia

Turkey has been a high inflationary environment for quite a while. W ith our distributor, they are a pharmaceutical company in Turkey. W hat the inflationary environment has done is impacted consumer demand. I t's just something we're paying a lot of attention to. We're working with our partner to help them as much as possible in terms of driving the marketing and sales. I t's just something where Turkey has become a little bit of a bigger impact in the quarter for us, because of some of these negative impacts from the economy.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay, so it has nothing to do with the partner. It's the underlying demand that's the problem.

Theresa Agnew
CEO, BioGaia

No, it doesn't have to do with the partner itself. It's more the overall market, in terms of what's impacting the demand.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay, thank you. T hen my final question, i t seems the strong momentum continues in the U.S. Could you provide some figure, how much you're growing in, in the U.S. right now maybe year to date? Just a rough figure.

Theresa Agnew
CEO, BioGaia

Sure. T he U.S. is growing ahead of market, so I would say it's high single digits. W hat's doing extremely well is our Amazon business. W e are disproportionately growing in our Amazon business, and actually we're having record months, really each month on Amazon. Amazon, as you know, is our main channel where we distribute, but also positively impacting us is, we also have distribution at Target, which is one of the mass retailers in the United States. T hey are very pleased with our Protectis drops business, and they've now expanded our Protectis drops in another 800 stores. I t's a really strong distribution now in Target, s o I would say, the Amazon sales are positive. The Target sales are positive. We also have strong growth on Walmart.com as well.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Thank you. I'll get back to the queue.

Theresa Agnew
CEO, BioGaia

One thing also is, all of this is [audio distortion].

Operator

Next question comes from [Mattias from Haggblom]. Please go ahead.

Yeah, good morning. Mattias [audio distortion] , thank you. I t wasn't clear to me how we should think about the phasing of the SEK 75 million-SEK 85 million that you intended to deploy in the second half. H ow much was taken in Q3 and what's left f or Q4? L inked to this, when do you expect to see an impact from these initiatives in terms of sales growth? Is that already Q4 or more likely Q1 and beyond?

Theresa Agnew
CEO, BioGaia

In terms of the spends, so we look each quarter at what we're spending of the amount that we've signaled. W e have spent in Q3. We are spending now in Q4. In terms of the impact in terms of sales, some of these investments are longer- term investments, so we won't see an immediate impact, positive impact in Q4, because we're investing in things like sales activities, which take longer to build a growth. They're very important though, in terms of our sustainable growth and our sustainable competitive advantage in the market, because it's part of our overarching medical marketing and medical sales strategy, going to healthcare professionals with our science and our advantages.

Actually, one of the things that we're seeing that is positive already from the sales activities is, our Protectis tablets in the U.S. have been growing more as well. W hat we do is we look at our sales activities in the States compared to some of the states where we don't have the sales activities, and so we're seeing positive growth of our products where we have increased our sales activities in those particular states in the United States. W e're seeing positive effects there on our drops, as well as now on our Protectis chewables as well.

T he exact amount, since you quantified the intent to spend SEK 75 million-SEK 85 million, it's not possible to quantify what has been spent or if that is still the intent for the second half? Just to help us understand how to think about OpEx for the remainder of the year.

Alexander Kotsinas
CFO, BioGaia

Yeah, Alex here. No, I can try to comment. I mean, our spending the SEK 75 million-SEK 85 million, I mean, since we communicated that figure, our sales, for example, now in the third quarter, has been a bit weaker, and always, we try to adapt our costs to our revenues. B asically, we have made some savings compared to them. We're still doing these strategic activities, and we will continue to do so in the fourth quarter. I think our total spending will probably be a bit lower than that SEK 75 million-SEK 85 million at the moment, due to the weaker sales we saw now in the third quarter.

T hen you have to also remember that we will normally spend more in the fourth quarter than our third quarter in terms of our OpEx, and it will be the same this year. W e will have higher costs in the fourth quarter rather than the third quarter. W e are pursuing those strategic initiatives. We are doing those things, but all in all, the total effect will probably be a bit slightly lower.

That's clear. T hen secondly, can you expand on the competitive pressure in Italy that you talked about? Is that derived from your previous distributor selling remaining stock under the previous brand, or is it linked to new entrants?

Theresa Agnew
CEO, BioGaia

It's not linked to new entrants. It's linked to current competitors in the market, but definitely also linked to our former distributor, because our former distributor has their own brand of different probiotics, different strains in the market, b ut it's also other competitors as well.

Okay.

I was just going to make an additional comment. One thing that is good is now we have direct, communication and establishment with Recordati, which is our now exclusive distributor. O ur activities with that partner are enhanced because we're able to give them more marketing, messages and support and training of their sales organizations. S ome of these things take time, but we feel like that support is even stronger than before, so we'll be able to have a competitive advantage versus some of the current competitors in the market.

That's clear. T hen finally, so when I look at consensus expectations for 2025 and 2026, it appears some of the forecasts suggest a depressed margin not only for 2024, but i n addition, 2025- 2026. D irectionally, I don't expect you to quantify, but any way to think about the duration of this investment period?

Yeah. W e're looking at it right now for the second half of this year, s o we're looking to see what the impact is. A s we said, some of the impact is longer term, so we have to look at trends. W e have to look at things, what was the previous period? What was the previous year? W e can look at the trends over time, s o we will continue to do our analysis. We're doing this weekly, monthly, looking at our sales, looking at impacts over time. I f things are moving in the right direction, then we will continue investments. F or right now, we're just looking at the ROI of the investments that we're making.

Thank you so much.

Operator

The next question comes from Kristofer Liljeberg from Carnegie Investment Bank. Please go ahead.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Great. Three more questions. First, following up on Italy and what you said about the competition. I s the former partner still selling the Reuterin brand, or is it another product they are marketing?

Theresa Agnew
CEO, BioGaia

They are still selling the Reuterin brand with different strains, so they are not selling our strains in the market.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Have they been selling that with different strains before, or have they just changed the strain after you terminated the agreement?

Theresa Agnew
CEO, BioGaia

They had launched a product previously to us terminating the agreement. They had launched a product with different strains. N ow they have also then launched an additional product, since then as well. T hey have a number of drops products in the market, as well as other formats.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay, and they could do so because you have stopped the previous agreement with them?

Theresa Agnew
CEO, BioGaia

That's correct.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

I guess, this brand, if I remember correctly, were larger than Reuflor in Italy before.

Theresa Agnew
CEO, BioGaia

No, actually Reuflor is the number one brand in the pediatric p robiotics area. Reuterin is much smaller.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay.

Theresa Agnew
CEO, BioGaia

Also, lower distribution in the pharmacies . Reuflor is the number one, and also has very broad distribution. T hey're growing from a smaller base, if you will.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay. I guess the problem then in Italy right now is that you so far haven't been able to retake this part of the market?

Theresa Agnew
CEO, BioGaia

Retake the part of the market.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

I mean, let's say, if we assume Reuflor was 20% of sales, and I guess your ambition must be to gain back that market share now when you're not collaborating with the previous distributor [audio distortion].

Theresa Agnew
CEO, BioGaia

Yes, that is correct. N ow, because our product was available previously under the Reuterin brand, a different SKU, now our goal is to take back that business under Reuflor. Because there were two different products in the market, our same product under two different brands, okay?

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Yeah, o kay.

Theresa Agnew
CEO, BioGaia

Now our goal is to take that market share now that that product is no longer available under Reuterin.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Yeah. Okay, that makes sense, t hanks. T hen could you comment, Australia, New Zealand, you said you were off to a good start there. Is it possible to comment how much sales you had there in the quarter, and whether that will increase in the coming quarters?

Theresa Agnew
CEO, BioGaia

Yes. I can't comment on the exact amount, but the sales that we've had are higher than what we've had previously, when you look at our sales to our former distributor. W e anticipate that it will continue to increase, because we're now driving our brand, but also driving the overall category at retail. T he retailers, so we have distribution in pharmacy channels, we also have distribution in one of the largest grocery store chains in Australia. Y es, we anticipate this to grow significantly, and also we will be looking at bringing some of the rest of our product portfolio into the market as well.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Did it have a meaningful impact on the strong growth rate in APAC in Q3?

Theresa Agnew
CEO, BioGaia

No, I would say not yet because it's so early. B asically, in Q3, we had pipe fill, what I would call pipe fill into pharmacies. The biggest impact was China and Indonesia, markets like that, b ut I anticipate it to have a bigger impact as we go, especially as we start bringing in some of our products that haven't been in that market before, at least in the pharmacy channel.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay, thanks. Okay, a nd then leading to my final question about China, which seems to continue to do very well. Maybe you could just spend one, two minutes explaining your position in China.

Theresa Agnew
CEO, BioGaia

Yes. We are seeing very strong growth in China, and that is mainly in the online sales channel. That's where the majority of our sales is, through general trade as well as cross-border trade, but mainly through general trade. O ur partner is doing a lot of events, a lot of marketing activities, driving a lot of focus on our brand, using influencers, using all the channels, live streaming to drive awareness, to drive trial and consideration. W e're very happy with the performance of our partner. T hey really capitalize on these big events like Singles' Day, where a lot of consumers are buying products and they end up disproportionately growing during those times. T hey're doing a really good job of targeting the right consumers with the right messages to drive conversion.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

What are the big products in China?

Theresa Agnew
CEO, BioGaia

I mean, our biggest is Protectis drops. That's our biggest by far, but we also have our Protectis chewables as well.

Kristofer Liljeberg
Analyst, Carnegie Investment Bank

Okay. Thank you very much.

Operator

The next question comes from Mattias Vadsten from SEB. Please go ahead.

Mattias Vadsten
Analyst, SEB

Yes. H i, t wo follow-ups. I think first one on growth, that has been, I think you said some 7% year- to- date. Comps look a bit easier for the fourth quarter, so is it relevant to expect growth well within the double-digit percentage trajectory for Q4? Or do you see any argument to be more cautious also for Q4 on the sales growth? That's the first one.

Theresa Agnew
CEO, BioGaia

We don't really provide guidance quarter by quarter. S ome of our areas, such as within EMEA, we're continuing to focus in those areas. W e want to turn around some of those businesses that have been declining, so t hat's probably where our biggest focus is for Q4. Also, obviously continuing the growth in our direct markets, you know, that's been very strong, so we want to continue to see that growth in Q4. O ur direct markets are where we are placing some of our investments. H opefully, that gives you a little bit of a sense for Q4, but we don't provide specific guidance on numbers.

Mattias Vadsten
Analyst, SEB

Okay, a nd how much of sales is direct markets now?

Theresa Agnew
CEO, BioGaia

It's still around 30%. We anticipate that now that we have Australia, New Zealand, those are smaller markets for us. It will continue to grow for us, but right now it's still around 30%.

Mattias Vadsten
Analyst, SEB

Good. T hen the last one from me. If you could flag what major sort of R&D project milestones, you can call it, that you have coming year or couple of years that we should think about? That's my last one.

Theresa Agnew
CEO, BioGaia

In terms of milestones, you know, we look at it two different ways. We look at new products and new product launches, as well as clinical studies. I n terms of our new product launches, we actually this quarter are launching a new product. I won't talk about that yet because that'll be in our Q4 report. W e're launching a new product as we speak, and then we'll be rolling that out to more markets next year. We also have some exciting new product launches planned for next year in the oral health area. I look at our pipeline, and we have a healthy pipeline of new products. The way our markets work, you know, not all of our markets take the new products at the same time.

Y ou know, we have a phase- out of our new products, because registration timings are different in each market. W hat we're trying to do is look at some of our direct markets to launch those earlier, as long as the registration requirements can be met. T hen in terms of clinical studies, we have an ongoing clinical study for our next- generation colic product. T hat is ongoing, and that is something that, we'll look at milestones on that in the coming year and years, s o that's exciting. T hen we have 30 ongoing clinical studies, you know, so we are always doing clinicals in various spaces. I would say one of the most exciting is around our next- generation colic product.

Mattias Vadsten
Analyst, SEB

Interesting. W hat you said there about the launching a new product, s hould we expect you to launch new products in new, how do you say? A reas of use or [audio distortion].

Theresa Agnew
CEO, BioGaia

No.

Mattias Vadsten
Analyst, SEB

Benefits for patients, o r is it tweaks to products within current areas?

Theresa Agnew
CEO, BioGaia

Yeah. T he products I'm talking about for this year, next year, or this quarter and next year, are more what we call line extensions. T hey're new products in the areas where we operate in our core, s o in the gut health area, in the oral health area and so forth.

Mattias Vadsten
Analyst, SEB

That's fully clear. Thank you very much.

Operator

The next question comes from [Mattias from Haggblom]. Please go ahead.

Yeah, thanks so much. Just a follow-up here. O n the next- generation colic product, is that the combination of the two strains that you referenced earlier this year?

Theresa Agnew
CEO, BioGaia

It is a combination of two strains, yes.

Okay. A gain, sticking to the publication earlier this year, I think in June, that you suggest you were bringing into clinical trials, I think that was also associated with some of the science within MetaboGen. A ny read across from the failed trial in metabolic syndrome and the impairment that you took in this quarter to the new combination trial, trying to improve growth of Reuterin, if I understand correctly or no read across at all?

No, they are not connected at all. Actually, MetaboGen was a focus specifically around metabolic syndrome. T he clinical study that we've been involved in over the last couple of years was for people with pre-diabetes, trying to look at, when you add a probiotic, do you get a significant reduction in glucose, which then reduces your, what's called HbA1c, which is the primary measure for someone with diabetes or pre-diabetes. T his was specifically in patients with pre-diabetes, where we did not see a difference versus placebo in the primary endpoint. We did have a secondary endpoint, which was triglyceride improvement, where we did see a positive effect. T he next- generation colic product actually has nothing to do with MetaboGen. It's a completely different health area of focus and completely different strains.

As a consequence, is it not linked to the BGL47 strain that was part of the publication earlier this year?

It is not linked to that. That is something else that we're looking at for the future. That is a Bifido strain. T hat would be a different potential new product in the future.

That's helpful. Thanks so much.

Operator

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

Theresa Agnew
CEO, BioGaia

Thank you for your very good questions, as always. We appreciate it, and thank you for listening to our overall Q3 results. Take care.

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