Hello everyone, and thank you for joining today's presentation of ALK Q3 results and our full year outlook. Let's start by turning to slide two, where I'll introduce the presenters and the agenda. My name is Per Plotnikof, I'm Head of Investor Relations, and with me today are ALK CEO Carsten Hellmann and CFO Søren Jelert. Today, we'll bring you up to date on ALK's Q3 performance, sales trends across our regions and portfolio, and the financials year to date. Then we will give you an update on our strategic priorities before covering the updated full year outlook. As usual, we will end today's call with a Q&A session. If you please turn to slide number four, I'll hand you over to Carsten, and we'll get started.
Thank you, Per, and thank you all for joining us today. Let me kick things off with a couple of highlights. Q3 revenue increased by 11% in local currencies with growth in all regions, meaning that organic growth, sales growth for the first nine months was 13%. On top of this, we had a positive effect from currencies, and reported sales growth for the quarter was 14%. Tablet sales were at 19% growth year to date, but low on Q3, where we saw some wholesalers in Europe reducing stocks, while some patients also held back after a mild tree pollen season. Back in August, when we upgraded the full-year revenue forecast, we anticipated that tablets would make a large contribution to growth in Q3. Nevertheless, the full-year sales outlook is still close to our latest upgrade for tablets.
Oppositely, the non-tablet portfolio is making a larger contribution than expected. Strong performance from other products, especially Jext, resulted in high single-digit growth in Q3. Operating profit year to date was up 27%, and the ongoing inflationary pressure on gross margin and capacity cost is still projected to be modest in 2022. In light of the performance year to date and the current sales momentum, we are updating the full year outlook. We'll come to this shortly. Finally, we continue to execute on our strategic agenda. The ongoing phase III trials remain on track, while we have recruited the first patients onto our phase I peanut trial. Meanwhile, we continue to evaluate initiatives to strengthen our platform, both short and long term.
With that quick overview, I'll hand over to Søren, who will take a closer look at sales trends on slide four.
Thanks, Carsten. As you can see, third quarter was a quarter with broad-based growth from all regions. Let's look at Europe first, where sales were up 6%. Tablet sales grew by 13%, but sales were impacted negatively by the initiation season of the tree pollen and wholesaler destocking, which we believe is linked to the weak tree pollen season earlier this year. ITULAZAX, however, continued to gain market shares among new initiators. Despite this, our biggest market, Germany, delivered double-digit growth and increasing market shares. Other important markets also recorded good growth. Jext continued its strong momentum with 36% growth, partially driven by continued supply interruptions among competitors. In North America, we saw growth of 16% driven by life science products and SCIT. On the other hand, tablet sales were weak due to the long-standing market barriers in the U.S.
In contrast, Canada is doing well. Revenue from international markets were up 24%. This reflected high level of SCIT shipments to China. Tablets grew by 18% as shipments to Japan increased further over the already high level of last year. Fundamentally, both China and Japan are on a good trajectory, although both markets were temporarily impacted by COVID, which also saw Torii adjust their full year expectations for in-market tablet sales the other week. Now let's take a closer look at the product categories on slide five. Revenue from the tablet portfolio was up 13% globally in Q3, and I just mentioned some of the influences just before. Combined SCIT and SLIT sales increased 1% on growth from international markets, especially China. Growth from the bulk SCIT products in North America remained on a level with the first half of the year.
Sales of other products were up 29% and sustained their strong momentum for the first half year, mainly on strong growth in Jext sales and sales of other products in North America. All in all, we are well on course to deliver on our guidance on double-digit growth for 2022. This brings us to slide six and the P&L. Revenue for the first nine months was up 13% in local currencies to DKK 3.3 billion. The higher US dollar had a positive currency impact so that reported growth was 16%. The gross margin improved by two percentage points to 62%, reflecting increased sales of ITULAZAX in particular and production efficiencies, although this was somewhat offset by increased shipments to Torii in Japan at a lower margin. Furthermore, in third quarter, we had one-off costs associated with discontinuation of a non-strategic product.
EBITDA increased 27% in reported currencies to DKK 507 million, corresponding to an EBITDA margin of 16%. Capacity costs increased 11% in local currencies. Sales and marketing spend was up 13% due to investments in market expansion in China and in general high activity levels. Finally, free cash flow was positive at DKK 93 million. This reflected changes to working capital, build-up of capacity for tablet production, upgrades to legacy production, and investments in in-house adrenaline auto-injector currently in development. Now, let's move on to a brief strategy status on slide seven, and over to Carsten again.
Thank you, Søren. Let us take a look at the progress we have made on our strategic priorities in Q3. As you will recall, we have four focus areas which are shown here on the slide. For North America, we've spoken regularly about the long-established market barriers where allergists are disincentivized monetarily to prescribe tablets, which stand in the way of tablet adoption in the U.S. This situation continues to prevent us from developing the market in the way we would like to do with the allergists. Even so, we still have a significant number of prescribers, and we continue to engage digitally with consumers, while we also invest in and access new business models for the future.
In addition, work to prepare for and secure pediatric and adolescent indication for the house dust mite tablet remains on track to be launched over the coming years in the U.S. In Q3, we continued efforts to complete and commercialize the tablet portfolio globally throughout the ongoing phase III clinical trials. MT-12, our pediatric trial in Europe and North America on the house dust mite in allergic rhinitis, is on track. We do have a number of trial subjects in Russia and Ukraine, but there have been a very minimal dropout rate to date. TT-06, our pediatric trial in Europe and Canada for the tree tablet, is our pediatric trial in Europe and Canada of the tree tablet. This also includes some participants in Russia, but again, there have been very few dropouts, and this trial also remains on track.
In China, work continued ahead of an ALK regulatory submission for the house dust mite tablet later this year. Our pharma partner also carries on with the regulatory proceeding for Jext in China. On a new horizon priority, work on the peanut tablet progressed with the recruitment of the first patients for the phase I trial, PT-01. Work also continued on the two adrenaline auto-injector projects, where we're still on target for a 2024 submission to the FDA in the USA. Meanwhile, we continued our work to develop and leverage our digital ecosystems, which aims to engage with treatment-eligible patients digitally and connect them with prescribers.
Finally, under our Optimize for Excellence priority, a quick word about the most recent employee engagement survey, where we did not only have a 95% response rate but also saw us improve our engagement score from 8.2- 8.3, which places ALK among the top 5% of international companies on engagement for employees. Now let's move on to the updated outlook on slide eight, and back to Søren.
Our full year outlook has been revised, and we have lifted the floor of the growth range. We now expect revenue growth at 11%-13% versus previous outlook of 10%-13% growth. Growth from tablets is now expected at a level somewhat below 20% in 2022, primarily driven, based on the weaker performance in Europe. This compares to the previous expectations of minimum 20%. The non-tablet portfolio is expected to make stronger contribution to overall growth in line with the trends we have seen year-to-date. We now expect sales of non-tablet products to grow high single digits, up from mid-single digits in August and from low single digits in February.
The midpoint of the projected revenue range now assumes that total sales in Europe will be slightly below 10%, whereas sales growth in North America is now expected to exceed 10%, and growth in international markets is still expected to significantly exceed 10%. The higher end of the projected revenue range assumes improved sales of legacy products and all tablets, while the lower end factors in further negative effects of destocking, COVID, and/or a weak tree pollen season in Europe. Based on the current exchange rate, we forecast a positive effect of approximately three percentage points in 2022. EBITDA is still projected between DKK 675 million and DKK 750 million based on an expected gross margin improvement of approximately one percentage point and a continued high activity level across the organization.
CapEx is now expected to be a little below DKK 400 million. Based on this, and since the vast majority of some specific accrued rebates will be rolled into the future, we now assume a free cash flow that will be positive in 2022. All in all, solid results with revenue growth and earnings improvements well in line with our long-term ambitions. With this, I'll hand you back to Per, who will now kick off the Q&A sessions on slide nine.
Thank you, Søren, and thank you, Carsten. This marks the end of the main part of our presentation, so we will now move to the usual Q&A session where we will be happy to take any of your questions. Please limit your questions to one to two per person before rejoining the queue again. With this, operator, please go ahead.
Yes. If you'd like to ask a question at this time, please press star one on your telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing star two. We'll take our first question from Ben Jackson from Jefferies.
Hi, it's Ben Jackson from Jefferies. Just two questions. Firstly, you flagged lower tablet initiations in Germany this quarter. Just want to understand, is that a one-time impact or are those patients that won't be coming back for treatment next year? Secondly, tablet momentum's historically been growing over 20%, but you're guiding for below that this year. In terms of growth rates for 2023 and beyond, is 20% or thereabout still how we should be thinking about it? Thank you.
Sorry, it was very hard to hear your question because a lot of echo from your phone. I'm sorry, could you just repeat again your question with a few sentences?
Yeah, sure. Let me just try that now. You flagged lower tablet initiations in Germany this quarter. Is that a one-time impact or are those patients that won't be coming back next year? Then just on tablet growth guidance, it's less than 20% this year that you've been guiding for historically. Just how should we be thinking about it, you know, in 2023 and beyond.
Okay. Thank you. Remember when we said about the market decline in tree tablet of about 7%-8% in Germany due to the pollen season. That was to reflect why we believe that some of the retailers are destocking a little bit, why we saw these sales of about DKK 50 million or EUR 7-EUR 8 million to be lower than we expected. We always said around 20% this year, and then we upgraded after first half because of the momentum to above, and now we say below. Just remember, we are talking about this range here. We still have some months to go for initiations, and whether we're going to stick to 20%, I cannot guarantee that forever.
However, we will also next year expect 10% growth for the company, and we will have more than 10% growth on the tablets and less than 10% growth for the legacy business, and we will make sure that we focus all we can to keep up the high growth. Remember, we have never ever initiated as many patients as we do already today. It's not like we have any tablet issues as such. We just saw a little glitch from what we expected to do more to do less in the range of EUR 7 million this quarter.
Got it. Cheers. Thanks a lot.
Our next question comes from Thomas Bowers from Danske Bank.
Yes, thank you very much. A couple of questions for me. Just maybe could you comment a little bit on how the new patient initiations looks like in the fourth quarter? Is there any, let's say, macro effects, for example, patients with a sort of an element of out-of-pocket paying delaying therapy, so also maybe implying some softness to next year's outlook? Just on your pricing power in Europe in order to sort of offset price inflation, do you have any indications from payers, governments, anything that could maybe allow you to raise prices at some point in order to mitigate cost inflation?
I guess you have quite a lot with close to DKK 2 billion in wage costs and of course also the energy and raw materials. Any comments from that be appreciated. Thank you.
Yeah. Thank you. Regarding first of all, the patients and their purchasing power, we have 75%-80% of our patients are fully covered by government insurance, so they don't have any out-of-pocket payments. We don't expect that the situation about gas prices, electricity costs, and so forth is going to play an influence here. We also expect that we'll have sort of a normalized Q4. We don't know that yet, but of course, we're doing everything we can to keep up the pace there.
Regarding pricing power, actually on the contrary, we already saw a bill coming out from the German government demanding that all pharma companies in Germany increase their rebate of about 5%, next year, which is for us something in the range of DKK 50 million or again EUR 7-EUR 8-ish million , which is going to be something we have to handle. For energy and transportation cost, you just have to. Remember, it's only for 2023, the German demand of the price reduction. For energy and transportation cost, first of all, energy costs, we have hedged for 2023, most of it. Secondly, we do not have that much of energy and transportation cost.
I think the total cost for energy in ALK globally is less than EUR 8-EUR 9 million and approximately the same number for transport. Even though those costs doubled in our cost base is still within the frame of the size of our business. Patients are mostly covered. Pricing power, we saw, and we managed to take up the prices for the bulk business in the U.S. We also took up the prices for Venom in Europe. For the tablets, they are more fixed by the governments, and I don't think they will allow us to increase the prices. But on the other hand, we don't see the same pressure as many other companies does.
For inflationary salaries, I think we are within plus minus a percentage points of what we had planned already, and I think we will manage.
Great. Thank you very much.
Our next question comes from Michael Novod from Nordea.
Thank you very much. Just a question to the U.S. strategy. I've seen your report that, and also on your slides, that you are sort of assessing new business models in the U.S. Maybe you could elaborate a bit on that. I know you just put in a new head of the U.S. business, so it would just be interesting to see what your thoughts are on that. On a second question, maybe you could elaborate a bit on also going into next year. I know it's premature to guide but where you see sort of the largest negative impact per tablet product. Is it on ACARIZAX? Is it on GRAZAX? Or is it on ITULAZAX? Maybe you could just rank them.
It would be highly appreciated. Thank you.
Thank you so much. Starting with the U.S., what we're doing is some of the same but still a little bit different. We are focusing a little more on selected areas in the U.S. instead of going broad on the allergy side, which seems to be a more efficient way of doing it. We are also starting now to inroad via the dual indication we got and the pediatric indication we already have just prior to ACARIZAX coming out for children as well to move into the pediatric segment and understanding what are the hurdles or bottlenecks we need to address in order to be successful in the pediatric segment. On the third one we're doing on reframing it still with digital.
We have now had the first patients through a fully digital system, and meaning that we mobilize the patients digitally, taking some online consultation, home testing, and then, you know, onset. There are still some things we need to work out, some specifications in our label. What is a medical setting? Is that a doctor in a home of a patient, or is this a doctor's office and stuff like that? Which we're figuring out right now. We definitely continue to invest in the U.S., and we are making sure that we learn from all the things that does not work and just focus on the things that does work.
Regarding our tablets, I don't think that there's any of the tablets as such that should be in trouble or not growing or anything like that, compared to what they do today. Of course, we're not launching any new tablets next year, but I think we have seen the halo effect. We have seen that all the tablets are growing well. We're taking market share. Despite the market settled a little bit in Q3 in Germany, we actually grew and took a lot of market share. We know that from the in-market data.
I think all in all, it's a lot up to us to execute, and do the sales and marketing activities properly, and I think we will be okay for all three tablets on the level we see now.
Okay. Thank you very much.
Our next question comes from Benjamin Silverstone from ABG.
Thank you so much. I have two questions. Thank you. The first one is regarding the destocking in the tablets. Could you just give us an indication of the scale of this destocking and also if there is any visibility into how to potentially catch this effect, in the next quarters or if it's something we should expect to come again? The second question is regarding the rebate in Germany. Just to make sure that we understood it correctly, it is a 5% additional rebate to be paid in 2024, 2023, and is it correct to assume that it will normalize again from 2024? Thank you.
Yes. Hi, this is Søren speaking. I think on the destocking, I think it's a super good question, and to some extent, this destocking also was a little bit different than what we anticipated as, the lion's share of the change is actually more linked to parallel trade, where it's a little bit more difficult to exactly see where it's bought ex-factory, what country it's bought in a factory, and then what market it's sold into in-market sales. Normally it's a little challenging to see that until after the fact, in this case, as we then see in-market sales per country, and that's actually what changed or challenged us a little bit. Bear in mind that we are talking a challenge here of DKK 15 million-DKK 20 million.
It's actually in the bigger scheme of things relatively small. Had it been bigger, it would probably be easier to detect, but as it's this magnitude, it's actually quite difficult to detect except for on the back of it. That's still what puzzled us and actually also what during the Q2 actually was basically not visible for us. Didn't become visible actually until we saw the true in-market sales here in September. That's actually the trade side of your question. No, you cannot evidently see it anywhere, and it's to this tune, DKK 15-DKK 20 million, and again, put it in the perspective of DKK 500 million a quarter or DKK 2.1 billion a year, then it's relatively modest.
Speaking of the German rebate, as Carsten talked about, as you know, there is today a mandatory rebate in Germany from 7%. That's the one they have lifted to 12%. They have been very explicit in stating that it's a 2023 one only. The good thing about the Germans is that they stick to their promise. In our mind, it goes out of the equation again in 2024. Yes, it is equally against all our product lines. In this case, 40% at a sort of DKK 40 million of it approximately is the tablets. Of course, it's dominating by the tree and grass as that's why we sell most in Germany.
I hope that clarifies the DKK 50 million in total in Germany. 80% of that is tablet driven, and it's a one-year effect as it's been stated by the German government.
Thank you very much, Søren.
Our next question comes from Jesper Ilsøe from Carnegie.
Yes. Thank you so much. Just going back to the German price cut, just making sure. Has the German government actually confirmed it would be reversed in 2024, or will there be a chance where they could actually say, "Well, we saved some money and therefore it will also be this new rebate level in 2024 onwards"? Just on Torii, you say that COVID is the primary driver behind the weakness in Torii's numbers. What data points do you actually have, or is it mainly your own speculation? Thirdly, on the potential recession impact on allergy medicines in the coming years, perhaps you can just give your thoughts, high-level thoughts on how this could potentially impact you.
Sorry for asking the last question, but if you take all these headwinds together, you normally guide for 8%-12% growth when you enter a new year. Is it fair to say this will be a few percentage points less in 2023 given the headwind you have, or do you still expect some 10% growth next year? Thank you.
I can start, and then Søren will take over. You mentioned a lot of headwinds like purchasing power and stuff like that. I think I addressed that earlier that we don't believe that that's going to be a major negative driver for us, as well as we have both hedged energy and we do not have that much transportation costs. I don't think that you should expect that we will go significantly away from the guidance we have done previously for the years to come. Fundamentally, our business are very strong. I mean, remember, we are posting a 13% organic growth year to date and 20% profits up. The long-term plan I've communicated, we still stick to. There will be maybe some ins and outs, but in totality, I don't think they will have massive headwinds, so to speak.
Just go back to the German. They have done it before in history in Germany, having these in a one-off payment from pharmaceutical industry, and they have always stuck to what they said. It's this period or this year or this half year you're going to do something. They have explicitly said this is for a 2023. It's not just ALK, for the whole pharma industry. It's a 2023 year thing that we wanted to increase the rebate by these 5 percentage points. Having said that, you know, I don't know what politicians would do, but it would surprise me a lot if the German government suddenly for the first time did not do it, stuck to what they said.
When it comes to Japan, I think no, we are actually assessing what Torii is also putting into the market in terms of the growth underlying. They have a good growth. They have a very good tradition for adherence in Japan. It's for them a mix of the initiations. Overall, we see them as a very strong performing partner. They are doing really well in terms of the growth. Was it a reduced outlook they gave? It was, and that sort of mainly affected our royalty payments for the end market. Overall, they're still a strong growth company, and they expect to continue to do so. That's definitely the Japanese story. You had something on recession and allergy.
I basically don't think that that's going to affect us that much as Carsten talked through that the majority of our patients are well covered. We do not consider that as a major new risk factor.
Okay. Thanks so much.
Our next question comes from Martin Parkhøi from SEB.
Correct. Martin Parkhøi, SEB. Just firstly on the guidance, I just need to understand the guidance because if you take the 2% split on the top line that corresponds to sales of around DKK 78 million, and you still have a split with an EBITDA of DKK 75 million and giving a gross margin to the tune of 60%, then you should expect that would be that level of the 78% which would impact the EBITDA line. Why do we still have this wide range, or should we maybe in reality take the range and then remove these DKK 25 million-DKK 30 million that you have in one-off costs this year?
Secondly, I don't know if you said it, Carsten, but missed out the wage inflation, did you say how much wage inflation that you expected in totality of ALK next year? Just on the DKK 50-DKK 60 million that you have reduced tablet sales guidance with for this year, I can't remember the issue. Is that as well? Wanted to split how much of that was actually in Q3. That was all.
Okay. Couple of questions. To start off with the last one, it's approximately half of it that is linked to quarter three. So likely you can then calculate what quarter four is. When it comes to the earnings profile, a little unclear what exactly you are asking, but what I will say is that we expect that the impact on these one-offs is approximately at least DKK 25 million, and this is also the underlying reason why we were not just removing the lower part of the guidance.
Basically, these DKK 25 keeps us to still confirm the DKK 675 as the bottom range, whereas the DKK 750 is basically driven still by a high end of the revenue and then a probably more favorable cost pattern. It's you can say you're right in assessing the DKK 675 as probably as safe as we now have baked in this one-off. I think that's fair to say, but we also want to ensure that we have the necessary freedom to support the growth for next year going into fourth quarter.
Yeah.
No, I did not say exactly the percentage, because I haven't told the employees yet for wages.
I guess that, Carsten, if you can split your sales for, I think that Søren Jelert, he alluded to DKK 2 billion in wages. How much of that is blue collar and how much is white collar?
I think that's a super good question. It's not a percentage that we focus too much on in terms of that. I mean, we are dominated by white collar in production as we are, so in that sense, I think it's. When you talk about salary increases, I also think you pretty much have to look at what's the country mix of where you are besides actually whether it's white or blue. Then I think also you should consider that.
What is the country mix?
Sorry?
What is the country mix?
The country mix of. We of course have two sites in the U.S. We have one site in Spain, we have one in France, and we have one in Denmark. We have a quite widespread country mix when it comes to our production network. When it comes to the sales reps, I mean, that's evidently of course spread over the globe. I'm a little bit unsure of what you are trying to ask for actually here.
That was the first question. I was asking for the wage inflation in total, but I didn't get that, then I tried to dissect it.
No, I think it's a good question actually. It's definitely a question that many are trying to get their head around and exactly what is going to be. Is there going to also be a recession, and how will that actually impact, and when that is coming, and what wage increases will you go by? I think it's fair to expect that we are probably higher than going into 2022, but exactly what level, I think Carsten is absolutely right. There we need to reserve the right also to discuss it with our employees and local country management before we go into that. Overall, I think we have a solid model and we are not afraid of what we're looking into currently.
Just a follow-up question on that. What is the turnover in employees now? You know, the job market has, I guess, also changed a bit over the last six months. Has that also changed for ALK, the turnover in employees?
Yeah. It has actually changed, and we are at 13%, and that's a little notch up, that turnover. And again, here, it fluctuates quite a lot. For instance, we have a shared service center in Poland where we've seen quite a lot of turnover in the back office. There's a lot of stability when you then go to Spain and France. We've seen a little bit in the U.S., and then we have seen people going in and out in Denmark. Overall, we are at 13%, which is not dramatically high, but it is a notch higher than what we've seen historically.
Thank you very much.
Once again, that is star and one if you'd like to ask a question. Our next question comes from Jacob Michael from Kempen.
Hi there, and thanks for taking my question. I'm just curious if you can provide a progress update on the status of the peanut allergy trial, and when should we expect next year to see some data from this program?
Yeah, I can give you that update. The trial is progressing. The first patients have been included. We will have anticipatedly several data points reading out from this trial next year. The trial is split in two parts. One part that will conclude in the first half of next year, and we expect to be able to communicate some of the findings from the first part of the trial, hopefully, sometime before summer. Conclusions on the second part of the trial and the overall conclusion towards the fall and winter next year. It's a trial that will involve 100 subjects in 15 centers in the U.S., and recruitment is ongoing.
Okay. Thank you.
It appears we have no more questions at this time. I will now turn the program back over to the speakers for any additional or closing remarks.
Excellent. Thank you all for good questions, and thank you for joining today's call. As you can see from the final slide here on number ten, we have several presentations scheduled. We hope to see you at some of these events. Also shown here is the publication date of our annual report in the beginning of February. As always, you're always welcome to call Søren, Carsten, or myself at any time if you have further questions. With that, thank you very much and goodbye.