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Hello, everyone, and welcome to this presentation of ALK's Q1 results. Please turn to Slide #2 for the agenda and today's presenters. My name is Per Plotnikof. I'm Head of Investor Relations. And with me today are President and CEO, Carsten Hellmann; as well as Group CFO and Executive Vice President, Søren Jelert. During today's presentation, we will take you through the highlights from Q1, the regional sales trends and results and then we will provide a brief update on our 4 business priorities followed by the full year outlook and a Q&A session. And with these opening remarks, I will hand you over to Carsten Hellmann for a summary of ALK's performance in Q1. Slide #3 please, and over to you, Carsten.
Thanks, Per, and thank you all for joining this call. We shall kick off with a couple of highlights. We delivered a broad-based growth across all regions in Q1 with accelerated growth in tablet sales, further stabilization of our legacy AIT business as well as high growth from other products. As you should all know by now, our ambition from 2019 and onwards is to enter the double-digit growth territory with double of the average annual growth over the last 10 years. We made a good start in Q1 by delivering 14% organic growth in local currencies. Revenue totaled at DKK 860 million, which is the highest ever quarter turnover in ALK. Tablet sales increased 52%, and our strategic investment in these products are allowing us to take advantage of both market expansion and a general transition towards standardized, registered AIT products, particularly in Europe and Japan. We are increasingly confident that the trend of the last 4 to 5 quarters represents a paradigm shift that will enable us to sustain growth rates of 30% or more going forward. Another encouraging trend was the further stabilization of our legacy SCIT and SLIT-drops business with our sales level with last year. Previously, these sales were hard hit by supply constraints and portfolio rationalizations with sales further stabilized in Q1 driven by our SCIT products. In just one example of this, SCIT sales grew for the first time in 11 quarters in the main SCIT market of Germany. So it seems reasonable to conclude that our investments in these area over the past 2 years are paying off. We also saw further progress in our strategic agenda in Q1, which we'll detail later. First, I will hand you over to Søren with an update on market trends on Slide 4.
Thank you, Carsten. Revenue in Europe grew by 8%, which was DKK 650 million, which was slightly ahead of plans. As you know, we are in the middle of phasing out all the legacy products to focus the portfolio on the registered, documented AIT products. We continue to see solid, typically double-digit growth in markets where this transition is most advanced, for example, in Nordic countries, Eastern Europe and Benelux. Germany also became a member of this double-digit club in Q1 with growth driven both by tablets and our legacy projects. Sales also picked up in other markets, although France remained a special case. We continue to see a strong uptake of tablets in France, where the market also continues to normalize following the disruption caused by manufacturing issues in recent years. However, a strong uptake of ACARIZAX is, to some extent, cannibalizing SLIT-drops sales. Nevertheless, we remain overall market leader in France. Europe tablets grew by 34% with double-digit growth in all markets. Combined SCIT and SLIT-drops sales were down 3%, and SCIT sales gradually recovered while SLIT-drops were down. Finally, sales of other products increased 24%. This was mainly due to 46% growth from our adrenaline auto-injector, Jext. The recent spike in Jext demand is due to market supply disruptions, but we expect the spike to ease off as the market will gradually normalize. Please turn to Slide #5. Turning to our 2 other sales regions. Both performed at or above expectations. Revenue in North America grew by 11% in local currencies to DKK 156 million, well on course for the full year revenue growth of 10% or more. Growth was recorded across all product segments, 50% for tablets, 8% for bulk allergen extracts and 7% for diagnostics and other products. Carsten will talk to you more about this shortly. International markets reported 198% growth, driven by the 2 region's largest markets, China and Japan. In Japan, our partner, Torii, continues to see a strong growth from the tablets. Now let me move to Slide 6 and the quarter 1 financials. Revenue came at DKK 867 million, up 15% in DKK and 14% in local currencies and confirming our strong start of the year. Gross profit of DKK 532 million yield a gross margin of 61%, an improvement of 2 percentage points, reflecting higher sales with increased SLIT-tablets volume well within existing manufacturing capacity. Conversely, gross margin was impacted by cost of compliance measures as work to ensure robustness in product supply. Capacity costs were up 14% in local currencies to DKK 456 million. This was largely due to the planned 20% increase in R&D cost to fund the ongoing clinical trial programs. Sales and marketing expenses rose 11% to support the buildup of the U.S. forthcoming product launches as well as the development of a new digital platform and consumer care activities. EBITDA was up 46% to DKK 133 million as we benefited from higher sales, better margins and operational efficiencies. IFRS 16 had a positive effect of DKK 9 million in quarter 1. Looking at the cash flow. We continue to reduce the cash burn associated with the transformation of ALK. Free cash flow was an outflow of DKK 17 million in quarter 1 versus DKK 75 million outflow last year. This was mainly due to an improvement in the cash flow from operating activities, which was an inflow of DKK 30 million versus an outflow of DKK 38 million last year. This improvement was driven by higher profits and was partly offset by plan changes in working capital. All in all, these were solid results and I will now hand you back to Carsten for the strategy update on Slide 7.
Thanks, Søren. We are almost halfway through the 3-year transformation of ALK. The transformation is well underway and we continue to see better-than-expected results in most areas. Last year, we established strong momentum for the strategy, and our focus and execution continues in 2019. We believe that ALK is already in much better shape than it was, and while there is still much to do, we are increasingly confident that we are on track to transform ALK and deliver on our long-term financial ambitions. Let me take you through the latest progress in each of our 4 strategic focus areas, starting with Slide 8 and North America. With 11% growth in Q1, we are on track to deliver our target on -- of double-digit sales growth in North America this year. Q1 tablet sales amounted to DKK 20 million in line with our full year target of approximately DKK 100 million. In Q1, ALK continued its first-ever, direct-to-consumer campaign into the U.S.A., which targeted house dust mite allergy sufferers in specific territories during Q4 and Q1. The campaign encouraged some 50,000 patients to visit around 800 allergy specialists and support our message to allergists that ALK is a true partner that can mobilize patients to visit their clinics. With these allergists, the focus remains on building general acceptance of the tablet and specifically on growing both the prescriber base and prescription depth for ODACTRA. The full year goal here is to roughly double the number of doctors who are early adopters, and these are the most frequent prescribers of ODACTRA. We saw progress towards each of these goals in Q1, and the overall number of prescribers of SLIT-tablets now exceeds 1,600 in the U.S. Meanwhile, in Canada, the majority of allergy specialists are now regular prescribers, and our distribution setup is running better following the changes we made in 2018. From a field force perspective, we can see that driving tablet acceptance requires a particular mindset and skill set, and we are constantly refining and developing our field force to reflect this. We also see the territories with a good rep coverage, good market access and direct-to-consumer advertising have the strongest prescription trends, and sales tactics are being updated to reflect these, too. Meanwhile, commercial and insurance coverage is steadily improving. The vast majority of eligible patients in the U.S. and Canada have now access to reimbursement for ACARIZAX and ODACTRA. And in the U.S., we recently added formulary listing for our tablets with a major health care provider, Cigna. As an aside, our plans to expand the penicillin business in the North America currently await the outcome of discussion between our partner company and the U.S. regulator, the FDA. In summary, we remain focused on growing our business in this region, which we still believe to hold a considerable long-term growth upside for ALK, and we are working hard in different areas to find pockets where we can accelerate the trend, but it's a long-term journey we're on. With this, let's move on to Slide 9. Let's turn to the completion and commercialization of the tablet portfolio. I've already touched upon the strong commercial momentum in Q1. Breaking this down a little more, sales of house dust mite tablets more than doubled as grass tablets saw double-digit growth and other tablets also performed well, driven by the newly launched CEDARCURE tablet in Japan. As I mentioned earlier, we're definitely benefiting from a structural shift in the market that favors documented, clinically proven products most notably in Europe and Japan. In these regions, there's a better recognition of these needs of people who are suffering and affected by severe allergy. The potential benefit of SLIT-tablets are also better recognizing Medicare guidelines and by mainly prescribers. To illustrate this point, an ALK tablet, i.e. ACARIZAX or GRAZAX is today the most frequently initiated AIT treatment in its initiation in many European markets. Despite this progress, there is still much to be done to unlock the tablets' true potential. We will therefore continue to invest in support of improving the prescription depth among existing prescribers but also take the products into new markets and segments. Eminent priorities, besides further solidifying sales growth, include securing the European approval of the tree tablet followed by its first launches so that for the first time, ALK will have a tablet on the market for each of the world's 5 most important respiratory allergens. For ACARIZAX, we are undertaking pediatric and adolescent trials in Europe and North America, while the planned pivotal trial in China is progressing. Preparation for the Canadian submission of the tree tablet are also progressing. With these updates, let's turn to Slide 10. The third strategic pillar is to launch new services, digital innovations and products to engage with and support many more people with allergy. This year, we raised the bar considerably on digital engagement and we made strong progress in Q1. We estimate that consumers saw 23 million messages from our klarify.me platform, already beating our full year target of 20 million. There were 27,000 new downloads of our prize-winning mobile app, klara, versus a full year target of 100,000. We registered 50,000 online allergy test versus a full year target of 85,000. And we processed 19,000 searches for an allergy doctor, representing more than 40% of the full year target. However, this is much more than just a numbers game. This is about creating multiple touch points for consumers to mobilize them while we're also making ALK relevant to more people. We hope to leverage this emerging digital ecosystem to build awareness ahead of the launch of the tree tablet, and we continue to refine and strengthen our digital presence in our test markets of the U.K. and Germany before expanding to other markets. Also, in the U.K. and Germany, we have started piloting sales of allergy-related consumer products via selected leading pharmacy chains. Branded as klarify.me, these allergy relief products broaden ALK's presence and establish additional touch points for people who have allergy. This initiative is giving us a useful insight into building a broader-based allergy consumer franchise over the longer term. Meanwhile, our business development effort continue to build the portfolio of adjacent products and services. With this, let's turn to Slide 11 and to the last strategic pillar. The final component of the strategic -- of the strategy is to optimize and reallocate our resources to be more efficient, to always focus on what matters the most. In Q1, we continued to advance the wide-ranging efficiency program designed to ensure that ALK is fit for growth. A key element here is the new site strategy, which is largely on track, and designated each production facility as a center of manufacturing excellence. Quality, robustness and scalability also remain top priorities, along with the general move towards reducing supply chain costs as we continue our effort to phase out older competitive products. These moves are all expected to lead to a long-term improvement of the gross margins. Finally, we remain focused on sustainable change to our internal culture so that our entire ALK organization is clear on the focus and discipline needed to transform ALK. That's it for me. I hope this update has illustrated how we are progressing with the strategic agenda. We still have fundamental channels to address Northeastern North America and we still have a lot of work ahead, but we are on track or even better. I now hand you back to Søren for the full year outlook on Slide 12.
Thanks, Carsten. Based on our strong Q1 results, we believe that the full year performance is tracking towards the upper end of the guided range we gave in February. We have not changed the ranges of revenue and EBITDA as it's still early days. We have, however, refined the cash flow outlook in light of Q1, and let me just go through the details. We expect revenue to be in the upper half of the DKK 3.1 billion to DKK 3.3 billion range. Compared to 2018, we expect tablet sales to accelerate with growth well above 30% year-on-year, and we anticipate higher sales of other products except SLIT-drops, which are expected to decline. At this stage, we are not including material sales from consumer care products. For operating profit, we also see EBITDA at the upper half of the previous stated range of DKK 100 million to DKK 200 million. Positive influences here are obviously larger sales volumes and incrementally higher gross margins. In contrast, as you know, we are in the middle of transformation process, which is subduing earnings, while we continue to invest in growth and transformation. This year, we're allocating significant extra funds to clinical trials, while sales and marketing costs are expected to increase modestly over the full year. Free cash flow is also impacted by the many business investments we are making to support the strategy. Still, based on the positive performance in quarter 1, we have revised our outlook slightly so that we now expect free cash flow to be minus DKK 400 million or better. This includes DKK 200 million to DKK 250 million in CapEx investments that are related to the new site strategy, technology upgrades and capacity expansions. That's our latest view on the 2019 financials, but we always will continue to keep you posted on any significant developments. With this, I'll hand you back to Per and the Q&A session.
Thank you, Søren, and thank you, Carsten. And this concludes the main part of our presentation. And we are now ready to open up for the question-and-answer session. Operator, please go ahead.
[Operator Instructions] Our first question is from Peter Sehested from Handelsbanken.
It's Peter from Handelsbanken. Of course, congratulations on the very strong set of numbers. I have a couple of questions. First one related to your tablet sales trends in Europe. I note that you have seen an incremental sales increase of roughly DKK 50 million compared to Q1 of last year. And I just wanted to know whether, let's say, this DKK 50 million increase year-on-year on a quarterly basis is something that we should expect going forward. That's the first one. Second question related to your gross margin. They're clearly higher than anticipated. You previously guided for, let's say, a 2 percentage point increase if you saw tablet sales more than 30%. I mean updated estimates, et cetera, might look as you could do 40% on the tablet side this year, perhaps a little bit more. So my question is whether you're comfortable saying that the 2 percentage point increase on the gross margin perhaps looks a bit too conservative. My third question relates to SCIT/SLIT sales in Europe. Should we expect to see some increased cannibalization? I mean the growth pace in your tablets business is pretty strong. Unless those patients come from somewhere else, it's hard to imagine not to see some cannibalization. And the fourth question relates to sales in Japan. Also a good quarterly -- a good yearly increase on a quarterly basis. And just want to check whether that trend is stable or whether we should expect that perhaps it will go up a little bit.
I'll start. It's Carsten. I'll start with the last one, Japan. Yes, it is stable. And regarding the cannibalization before I hand it over to Søren, who can talk to the gross margins, I will say yes, of course, in certain markets where we have very high markets, yes, and introduce the tablets, for example, in [ France where it dropped ], you might see some. Well, we do actually, of course, see market expansion and market share gains. So it's not a 1 to 1. So it -- that's not what concerns us the most. And if you then look at how we actually are doing in general in SCIT and SLIT, even though we grew 52%, you don't see -- you see actually a stabilization of that as well. But we will manage that very carefully and -- but that's not our biggest concern. And then I will hand over to Søren, who will talk to the gross margins.
Yes. Then 2 questions left at least, Peter. The gross margins -- and it's absolutely right that we are benefiting, of course, from a stronger tablet growth in quarter 1. But we should also remain firm on that what we are expecting to see, the remainder quarter is actually that we will still continue to prune the portfolio and then we will still have the cost but the sales will not be there. We are still anticipating a price pressure in the later of the year, which would also, I mean, take down the margins a little bit. And then lastly, we have seen potentially quarter 1 being the last high jump for the Jext as we expect EpiPen to come in. And here, we have benefited from that, for sure, over the last couple of years -- over the last years, sorry, but we expect to be more normalized in the subsequent 3 quarters when it comes to Jext, and that will also pull down gross margin a little bit. So you're right that it is a very strong gross profit and we have said that we would sort of [ opted ] compared to last year, 1% or 2%. But of course, we hope for more, but I think that we have reason to believe that the guidance we've given is solid with the knowledge we have currently. So that's the gross margin. And then your last question was actually European sales, where we have 34% tablet growth in first quarter. And yes, we are expecting that, that will continue through the 30% mark going forward, but do not forget that when we come into next year, the tablet -- the tree tablet will be kicking in also. So we have reason to -- very good reason to believe that this high growth in Europe will continue on the tablets. I hope this answered your 4 questions, Peter.
Yes. I just have one follow-up and just one additional while I'm here now. I'll jump out again. So in relation to the gross margin and you mentioned that impact from Jext, I might recall wrongly but doesn't Jext have a gross margin that is below the group average? And the second question was just staying on tablets sales in Europe. I guess my underlying question is essentially was this. For 2019, we're seeing an incremental sales increase in Europe of around DKK 200 million. Do we -- should we expect this DKK 200 million annual incremental sales to continue over the next couple of years?
What we have said Peter, is that we are expecting to grow with the 30% mark range going forward also in '20. I think that -- then you can do the math. And what was the other question, Søren?
And the other question was, Peter, for sure and will actually -- irregardless our product has a lower gross margin, the fact you utilized your capacity better will always yield a better margin for you. So with the Jext situation, for the subsequent quarters, the fact that it's going down, will we still have the same fixed cost base? So it will actually negatively, although small, I would say, impact it as long as we are not utilizing the capacity to the same extent.
Our next question is from Michael Novod from Nordea Markets.
This is Michael Novod from Nordea. Just one question to the upcoming launch of the tree pollen tablets. So how do you expect the label to look like? And depending on that label, how long a potential season do you see for this product? Secondly, how do you judge the sales potential of this product compared to a tablet like GRAZAX just to get a feeling on how we should, say, try tree to model this going forward? And then also lastly, maybe I missed it, but you've been talking about a U.S. adrenaline strategy -- or at least you would update us on a U.S. adrenaline strategy. How should we look at this in 2019? Is this still the ambition that you can do something on the adrenaline side in the U.S.?
This is Carsten. For the tree tablet, we are very optimistic, but of course, it's depending regulatory review and I need to get that out in the open from the authorities before I can talk to you about the label, but we are planning a very aggressive and combined launch all to with all [ thirteen ] platform from the tree tablet. And a lot of things are happening right now. So we are very optimistic, but let's wait talking about that so we are in the legal sphere and so forth. Regarding the anaphylaxis strategy, there is absolutely no change from our side. It's up to us to decide when we want to communicate externally, and that's just a matter of when we think we have a platform which is so strong. So you'll be blown away to this sort of mark that's pretty much it.
And I think you had another -- Michael, just -- if you were to model one of the tablets, I think we say internally as I have said before that look towards grass when you look at tree.
[Operator Instructions] Our next question is from Philippa Gardner from Jefferies.
So I just got a couple of questions left. So I just wanted to ask -- or I was wondering if you could remind me in terms of the DTC campaign. Is that still ongoing? Or is that -- I seem to recall it was going to happen every couple of quarters. So I was just wondering if that's still ongoing or if that's something that you plan to continue for the rest of this year. And then I think on the last call when we were talking about guidance, you were saying that back where we were in sort of January, February, we haven't yet had the pricing hit in Europe. I was wondering if you have any updated comments around what we're seeing on pricing.
Thank you and thank you for the questions. The DTC campaign was a focused campaign running. I think it's running out now. So it's not something that we will -- can sustain at that cost level for the rest of the year. We will do more focused campaign going forward, and that's also what you see with the klara app and others. So we are planning to, of course, continue to engage more and more people with allergy, but it's not going to be a general efficacy campaign at these cost levels. Regarding the pricing, yes, we are still modeling in some price pressure in Southern Europe from the remaining -- from the last part of the year is the best way to say. But we haven't seen it yet. And for every quarter it's not hitting us, of course a good thing. But eventually, it is going to happen, but we haven't seen it yet. So I can only say that we have modeled in from the last part of the year, but we haven't seen it yet.
And our next question is from Thomas Bowers from Danske Bank.
Just also a few remaining at from me. Just on the SCIT sales in Germany now you're back on growth. So how should you see the coming quarters? Is it sort of -- do you expect sort of a more exponential bounce back? Or do you see any -- well, any other players in the market has been able to take over [ the result ] in those markets just here? So how should we think about SCIT going forward here? And then sorry, my line was breaking up a little bit on the gross margin. Did you say anything about sort of any one-off that have positively impacted the quarter? And also in regards to any comps on the Jext franchise expecting to have some tough comparisons going forward? And then lastly, just on the sales in rest of world or primarily Japan, how should we see -- because we have a -- well, a very strong quarter. So if anything -- because I guess you will see some fluctuations in sales [ to win ]. So is there some sort of one-off elements also positively impacting here in Q1? Or do you expect this to be relatively stable as well for the next couple of quarters?
Thank you, Thomas. I'll see if I got them all. Regarding SCIT in Germany, yes, we did lose market share for 2 reasons. One was we withdrew big product line from the market. And secondly, we also have -- or had significant issues in supplying with other products to supplement those. So we did lose market shares in Germany. So no, it's not going to be like a rocket. It just started now and we get the 25% [ mags ] point back that we lost. However, we are seeing that we have hit the bottom and we are coming back now and we are delivering strong and better results in Germany than we've done for a long time now. So that's for Germany. No, there was no big one-offs in the gross margins. So it's more maybe a confirmation for what some of you have been looking for whether we did have delivered when the tablet sales came in. And yes, that's what we're showing here. Japan, Q1, there's a lot of potential still in Japan. It's not a one-off quarter in Japan. We do expect the good momentum in Japan will try to continue. So there's nothing there. Jext, I was not sure I 100% understood you about comparables. What we just said was that we've been growing significantly with Jext due to the fact that there was market disruptions out there, and we do expect the competitor to come back. And when that happens, we would have pretty much the same cost of Jext with a little lower sales. So that's why that could have a small margin impact. Jext is still a good product doing very well in Europe, and we do not expect to lose everything we gained because the customers like our product. Will you add anything Søren?
No. I think that was -- that covered the questions.
Our next question is from Peter Sehested from Handelsbanken.
Yes. It's Peter again with a follow-up question. In relation to the, let's say, very positive media exposure that you had particularly in the U.S. but also, let's say, in Nordic newspapers, have you seen any, let's say, commercial impact? Have you been able to communicate to physicians, i.e. in the U.S., about more traffic into clinic, et cetera, et cetera? Just to get a sense for whether you have exploited this positive media exposure?
I'm sorry, Peter. There was something happening to the lines. So I must admit -- could you repeat the question and speak slowly? There was a little bit of thing, a hiccup there.
Yes. It's in relation to the very positive media exposure that you have received in the U.S. on national television, but also, let's say, in Nordic newspapers. And my question was whether you've been able to exploit this positive media exposure particularly in the U.S. in a commercial perspective, i.e. whether it's something that -- where you could argue to facilities now, we are helping driving, let's say, more increase into the clinic, et cetera, et cetera, I mean just to get a sense for whether you are able and whether you can exploit this kind of media attention in a commercial way.
The answer is absolutely yes. This is the whole idea by building all these patient engagement systems and the klarify and klara universe. We saw -- if you start with the Nordics, yes, it's true there was a lot of positive media and front pages just after up to the season. And we saw a significant drive into our apps and our website. And of course, we capitalized that, and that's also why you see a very, very heavy increase in find a doctor function, self-test and so forth. This is what it's all about. That is to generate more awareness because remember that when we were only in the space of prescription medicine, we were not able to talk about ALK and our products. So we couldn't get that notion out there with all the sufferers of allergy, which is 99% of the market, and that's actually what's happening now. Now we have platforms to capture that one, yes. And it's true that the morning news in the U.S. with 42 million viewers. There was a big section there about the tablet and the new treatment opportunities for patients in the U.S. It all helps. So this, combined with the DTC -- combined with our DTC platform to be -- hopefully we'll launch late this year, is going to drive more and more awareness, and that's what it will take. There will be a tipping point where the allergy doctors both recognize that we would not disappear. We are not going away, one. And secondly, the patient pool will go directly to the doctors and they will be asking for our products and it will become more and more and increasingly difficult. It also helps some of the prolific health segments in particular the U.S. market like the ENTs and others, in broader clinic settings who are not allergy specialists. There, the tablets and the drive and the notion about our products is helping them and we see some traction there as well. I'm not saying that, that will change the whole sentiment on the U.S. market very, very quickly, but that's why we see every single week, we get a little better, get more patients new to brand and so forth. And it's just going to be a long journey in the U.S. and in Europe. We are maxing out big time on all these press we get. For the first time in our history, we're able to do it because before, we could just sit there and say we can communicate because we're ALK and we're a pharma company.
Can we speak more about the, let's say, U.S. media strategy, the digital strategy tomorrow, but anything that you sort of want to throw up in the air right now regarding the U.S. media -- sorry, consumer digital platform? Is it the same kind that you have in Europe? Or are you experimenting with some new stuff here?
It will be -- I will not reveal anything because we want to take everybody by surprise when we do it. But having said that, every time we go into new market with this -- that's why we started with Germany and U.K., we make sure that we customize it for many reasons, by the way. The market is different but also the legal abilities, legal requirements are different. But it's a work in progress and we are not only on the digital consumer part but also in adjacent areas, looking at how can we make a sustainable business going forward in the U.S. be more and more relevant every day to people with allergies. And that's our aim and goal, but it takes some time. But we're not just doing opportunistically. We do have a plan and we're working very seriously on that plan.
And as there are no further questions, I will hand the word back to the speakers.
All right. Thank you all for your questions, and thank you for participating in today's call. We will wrap it up now. We have a few IR events lined up for later this month, and we hope to see you at one of these. In any case, do not hesitate to call me, Søren or Carsten if you have additional questions. Thank you all, and have a nice day. Goodbye.