Good morning, everyone, and welcome to this webcast regarding ALK's in-licensing of Neffy, the world's first approved nasal spray with adrenaline for the treatment of anaphylaxis. My name is Per Plotnikof. I'm head of investor relations. With me today are CEO Peter Halling, head of commercial operations EVP Søren Niegel, and CFO Claus Steensen Sølje.
In-licensing of Neffy, the world's first approved nasal spray with adrenaline for the treatment of anaphylaxis.
At our Capital Markets Day in June, we presented ALK's new strategy, Allergy Plus. Today's announcement delivers on key elements of this strategy as we progress towards establishing leading positions in the broader allergy space. I have to say that during the weekend, we announced the single largest in-licensing deal in ALK's history. For an upfront payment of DKK 145 million, we have acquired the rights for parts of the world to Neffy, the first and only approved nasal spray for emergency treatment of acute, potentially life-threatening allergic reactions. Neffy, a product with the potential to transform treatment and significantly expand our markets. Building on the first-mover advantage, we intend to build a substantial business in anaphylaxis in our key markets and beyond. We start now, approximately three years earlier than originally planned.
We also gain exclusive rights to all future indications, such as acute flares associated with urticaria, currently in phase 2 development by ARS Pharma. Urticaria is one of the disease areas we are targeting in the broader allergy area. The deal will contribute to growth from 2025 and onwards and be earnings-accretive within a few years. Longer term, we see highly attractive peak sales potential that will further amplify our underlying earnings development. Importantly, the deal also supports ALK's core AIT strategy, including our pediatric ambitions, as children and their caregivers are expected to favor needle-free, convenient anaphylaxis treatment going forward. In a little longer perspective, Neffy also fits perfectly in with our future product portfolio in food allergies because the frequency of anaphylaxis is particularly high with people suffering from food allergies.
Moreover, as with ALK's global portfolio approach in AIT, then with Neffy, Jext, and Genesis, we are building a strong global portfolio and a market position in anaphylaxis, currently being the only company with both adrenaline autoinjectors and a needle-free solution. To sum up, the in-licensing is a very important step in our strategic efforts to establish a leading position in anaphylaxis, food allergy, and other connected disease areas such as urticaria. A deal that will create strong synergies with our core business in respiratory allergy. Nephi, moreover, also supports our long-term financial ambitions, which remains unchanged. Claus will detail the financial impact later. Slide three, please. The license agreement with ARS Pharma grants ALK exclusive rights to commercialize Neffy in all territories globally, with the exception of the U.S., Australia, New Zealand, Japan, and China.
We will prioritize resources and initially focus on bringing Neffy to markets in Europe and Canada, where Neffy easily can be added to our existing infrastructure and sales channels, and where we can leverage the strong scientific and commercial links to our existing product portfolio. Europe is our main market, and Canada is a top 10 market for ALK today. Together, Europe and Canada constitute around one-third of the current world market for adrenaline autoinjectors, or pens, if we measure in volumes. European and Canadian AI autoinjector markets currently hold a combined value of around DKK 1.6 billion, with a significant untapped potential in both markets. Neffy's superior product profile also enables us to address low penetration or even white space markets in other regions, such as Asia, Latin America, and the Middle East. Now, let's turn to slide four and over to Søren. Projected market developments. Søren.
Take a closer look at our core European market. Let me briefly introduce Neffy. As you'll appreciate from the right side of the slide, Neffy is a small, compact nasal spray designed to provide rapid absorption of adrenaline. It's easy to carry, even when it's a pack of two devices, as recommended in international guidelines. It's also easier to administer for patients, for relatives, and for caregivers. In case of emergency.
You just insert it in the nose and press. The solution was well tolerated in clinical trials, and it offers longer shelf life and superior temperature stability compared to existing autoinjectors. We are convinced that Neffy offers the best solution to the challenges related to autoinjectors. Patients find pens bulky. Patients are, in general, uncomfortable with injection-based delivery of rescue medicine, also relatives and also caregivers. Patients do not administer when needed. They delay the administration or even fail to use it correctly. Moreover, most eligible patients don't even have an adrenaline pen, perhaps for the same reasons I just mentioned. That being said, many healthcare professionals and patients value the long-standing accommodation with our portfolio strategy. Slide five, please. In our main market, Europe, more than 20 million people are estimated to be at risk of severe allergic reactions.
Yet, only two million carry their rescue medication, and many people fail to renew their prescriptions. The current autoinjector market in Europe is approximately three times lower in units than the U.S. market, and the opportunity space in number of patients is 10 times up compared to the current market size. The European adrenaline autoinjector market has been growing by 8% per annum from 2013- 2023, again measured in units. And ALK has a market share of around 20%. We expect Neffy and future needle-free innovations to gradually transform treatment and accelerate market growth. Small needle-free solutions appeal to broader patient groups, especially patients with needle phobia or needle-related safety concerns, to children, to newly diagnosed patients, hesitating patients, or non-compliant patients carrying pens. Experiences from other emergency medicines moving from needle to nasal support these projections.
So, does key opinion leader insights and research among patients and prescribers suggest high willingness to adopt Neffy? We expect needle-free solutions to grab the lion's share of market growth, but also leave room for coexistence with autoinjectors. Our ambition is to become market leader in anaphylaxis in Europe, just as we are in AIT. We acknowledge that this is a long-haul effort and will expectedly take time. Slide six, please. In line with our Allergy Plus strategy, we will address the anaphylaxis market with a portfolio of solutions with multiple administration forms. A similar approach as we have to respiratory allergy, where we both market tablets, injections, and drops. Bringing a range of options to the markets will help us meet the diverse needs of patients and prescribers and position us to changes in clinical practices.
Hence, we will continue to market our existing adrenaline autoinjector, Jext, in Europe and selected international markets. We will also continue to develop a next-generation autoinjector, the Genesis project, with the ambition to launch in first markets by 2028. And finally, we'll have Neffy, where ARS supplies finished goods to ALK. So, an innovative portfolio fronted by the best-in-class Genesis pen and the first-in-class nasal solution, Neffy, backed by our legacy, Jext. We expect this to become a winning portfolio over time so that anaphylaxis, currently a business making up less than 5% of ALK revenue, will become an important revenue stream. Slide seven, please, and over to you, Claus.
Thanks, Søren. Let me take you through the expected timelines and the financial implications. In Europe, which is branded EURn effy, the product is currently authorized for use in adults and children weighing 30 kilos or more.
We will immediately initiate market access negotiations to settle pricing and reimbursement in key markets. We expect first launches to take place in the E.U. in the second half of 2025, with more launches to follow in 2026, 2027. Moreover, regulatory submissions for the important markets, U.K. and Canada, are being prepared, and Neffy could also become available in these markets in 2025, subject to approval. By the way, then U.K. is our largest adrenaline market today. Moving ahead, we expect a dose for children weighing 15-30 kilograms to become available late 2025, subject to approval, and this will further support our overall pediatric ambitions. In addition, we have potential add-ons such as indications for toddlers and indications in new disease areas under development, including urticaria, which Peter referred to.
Moving to the financial implications, ARS Pharma is entitled to an upfront payment of $145 million due for payment this year, as well as customary milestones payments related to specific events and double-digit tiered royalties in the teens on future sales. We will finance both the upfront payment and future milestone payments out of our available cash and credit facilities. After the upfront payment has been paid here in 2024, ALK will still have a very conservative debt structure with an expected net debt-to-EBITDA ratio well below one, and if everything goes accordingly to plan, the effect of this upfront payment will be washed out by the end of 2025 due to the expected positive cash flow development. Therefore, this leaves us with ample opportunities for further strategic investments while still maintaining a healthy profitability for the company.
Regarding top-line growth, we expect this deal to contribute from 2025, but the initial impact will be limited. Neffy will likely deliver less than one percentage point of ALK's revenue growth in 2025. We expect sales to gradually increase from 2026 and onwards, and we estimate that Neffy holds a mid-2030s annual peak sales potential of up to DKK 3 billion in anaphylaxis in the licensed territories. On top, there may be the upsides to this potential from new indications in other disease areas. The in-licensing will impact cost of sales in the form of cost of goods, i.e., our purchase price and royalties to ARS Pharma, as well as amortization of the upfront payment and milestone payments over a 15-year period. The in-licensing will also require additional sales reps and marketing expenses.
Still, Neffy is expected to become earnings-accretive in a few years, more precisely towards the end of the current strategy period. After 2028, we expect Neffy to contribute positively to ALK's earnings with an EBIT margin well above 25%. Let us turn to slide eight, please. To sum up, we remain confident that this deal is highly accretive to our Allergy Plus strategy. It allows us to start building sizable business revenue by at least 10% on average, and it supports our long-term earnings ambitions without jeopardizing the 25 in 25 ambition. After the current strategy period, Neffy EBIT margins are expected to exceed the 25%. With this summary, I would like to hand it back to you, Peter, and slide eight.
Thank you, Peter, and thank you. Thank you, Søren and Claus. And we will now move into the Q&A session, and I'll kindly ask the operator to go ahead.
Thank you, Søren. Ladies and gentlemen, if you would like to ask a question, please press star and one now. If you would like to remove your question from the queue, please press star and two. Again, if you would like to ask a question, please press star and then one now. The first question that we have comes from Thomas Bowers of Danske Bank. Please go ahead.
Yes, thank you very much, and congratulations on the deal here. A couple of questions from my side. First of all, on Jext, I'm just a bit curious on how this will affect Jext going forward, because I guess you will, of course, be first detailing Neffy. Does first-generation Jext fit into the longer-term portfolio? And then also, I see that you continue with Genesis, but is this maybe primarily for the U.S. market longer term, or how does this actually fit into the Neffy product? And then maybe just a few comments if you can on pricing potential. Of course, you have pending market access reviews, but is there anything that can argue against at least maybe a 50% premium here to Jext, given that you have more stability and also, of course, the very long shelf life? That looks quite impressive here.
And then maybe just my last question for now here, just on we have, of course, seen a lot of stock out in this segment. And also given that ARS Pharma will supply finished goods to ALK, so anything that we should sort of be aware of that could potentially become a risk of Sourcing, or of course, for example, if the US demand for Neffy is potentially higher than expected, where does that sort of leave you with product supply to Europe? Thank you.
Thanks, Thomas. This is Peter. I'll take the first question on Jext and Genesis, and I'll ask Søren to help on the pricing part, and then on the stock out, I can also add a few comments in terms of our supply security there. Just first and foremost, I think with Jext, we do believe that there will be succession over time, but we are also very firm believers that Jext and other injectors, including Genesis, when that is ready in 2028, will coexist and will actually be great solutions for both people who prefer to stay on existing solutions like EpiPens and then obviously the market-expanding products like Neffy. We see that Jext will continue, and we also see that Genesis fits in well.
So for us, it's been important to get a global portfolio that allows us to execute globally with our adrenaline auto-injectors that will continue. And then obviously with Neffy, we now have a really fantastic product that fits into our portfolio overall and will help us really expand and get this market to materialize to the extent that we've seen on the potential. So all in all, we'll continue with both, and we continue to see them coexist also going forward. And we see ALK being at a position with both products that is quite unique in the market globally. So maybe, Søren, on the pricing.
Yeah. Thank you, Peter. Yes, Thomas, I can confirm that we will definitely target a price premium compared to adrenaline auto-injectors. We do that because we think this will greatly benefit patients, and it will also be an advantage for healthcare professionals and society in general. So that I can confirm. Then the last question, Thomas, on the stock out and risk of supply. We have built-in mechanisms in the contract that will secure supply. As you know, it's been a market in the past that has been suffering from supply constraints and issues that now, step by step, have been resolved around Jext, but other PENS in the market have facing similar.
We don't believe that this will be the case around Neffy. The device is well established. There are currently seven indications where the suppliers and its multiple suppliers are three. Suppliers that are currently supplying the product to the market.
So we believe this will continue, and then more, it's quite a simple product to further scale up when you compare to other devices. So all in all, we're quite comfortable both with the contract that we have in place and also with the device in itself in terms of avoiding any stock out and risk of supply. Clear?
Perfect.
Thank you, Peter.
Thank you.
The next question we have comes from Martin Parkhøi of SEB. Please go ahead.
Yes, good morning, Martin Parkhøi at SEB. Firstly, some questions on the potential milestone regulatory payments of the $320 million. How back and loaded is this? And let's imagine that you hit the DKK 3 billion in peak sales as you hope for. How much of these $320 million will actually be paid? Because I guess that some of that is related to much higher sales than DKK 3 billion. Most of these questions on pricing, are there also milestones related to the pricing that you expect to obtain? And then finally, just on the territories that you have been able to obtain the rights, was it your decision on these markets? Of course, I understand that you want to reopen, but on the other markets that you did not obtain rights for, was that a decision by you or was it a decision by the seller?
Thanks, Martin. So let me start out by answering the pricing and the territories, and then I'll let Claus answer on the milestone payments. That's the very simple answer. It's connected to the sales achievements and revenue targets we set in. So no pricing milestones. Obviously, we have an interest that the product is priced fairly. And then on the territories, it's been a negotiation like anything else. Just to be clear, many of the territories not included in the deal, or actually all of them, either Neffy or ARS, wanted to launch themselves. This was the case for the U.S. Otherwise, they've been partnering both in Japan. They had a partner before we entered this deal, the same in China and the same in Australia and around New Zealand. So you could say we took the rest.
And without answering on behalf of ARS, then I think there has been a benefit to having one partner that could cover the rest of the world. And then obviously, you have the other territories with other partners or ARS themselves. And then maybe on the sales milestones, Claus?
Yeah, I can do that. Thanks, Martin, for that question. Sure, right. We have milestones in there over the next 15 years for around $320 million. That is what we call back loaded, meaning that the last part of this or significant part of this is only coming when the sales is quite high and actually also way above what we are calculating in our business case. We are not going into details much more than that, but it's just to understand that what we have in our business case, then we will, of course, pay a part of the milestones, but also just to say that it is back loaded. So we have to get much higher than what we have in our business case to pay the full amount.
Okay, thank you. If I could just take one follow-up question maybe for Peter. On the strategy plan that you put forward, you also had some ambitions on your comments on your R&D ratio. I guess there will not be a lot of R&D costs for you on this project since it's already approved. So it appears that it could actually dilute your R&D ratio. So do you still stick to the range for 2025- 2028 that you put forward on the R&D ratio in connection with your capital markets earlier this year?
So thanks, Martin. I think the short answer is you're right that this is obviously a commercially ready product, and that means that there are limited R&D investments. What we're happy about is the additional indications we've gotten that will hopefully lead to more work. The autoinjector is an important area for us. We have not changed the guidance and our long-term ambitions, but what's important to say is obviously we always take into account changes to the opportunity space and changes to the pipeline. And based on that, we'll choose where we invest the most.
That being said, when you acquire a product like this, you also want to make sure that you give it sufficient attention so we can execute in a great way. And then it's up to Søren to ensure that happens accordingly. And on top of that, we remain committed to building a balanced pipeline going forward. So we have a lot on the plate, but we're not changing the guidance we put out earlier.
Thank you.
Thank you. The next question we have comes from Jesper Ilsøe of Carnegie. Please go ahead.
Yes, I hope you can hear me.
Yes, we can hear you loud and clear, Jesper.
Okay, excellent. Yeah, thanks so much. Sorry. So a question on the market share potential. It seems when you look at other rescue markets such as the glucagon rescue market and the seizure rescue market, that these products achieve more than a 50% market share quite quickly for nasal sprays. What have you basically penciled into your assumptions for your peak sales? Because it seems on your slides that you assume the market to be three times as large by 2035, then comes premium prices on top. So that potentially implies a quite conservative market share. Is this correct that you have applied a quite conservative market share? Or perhaps you can just detail a bit more what you have basically plugged into your assumptions for the peak sales potential on Neffy. And then a question on the EBIT margin potential.
Just to understand sort of the costs that you expect over the coming years in your strategy period. You say it's accretive to earnings by 2038. Perhaps you can just help us with the modeling, how much incremental investment it actually requires, because I guess this is pretty plug and play and can be used with the existing sales force. Just to understand sort of the SG&A implications the coming years could be helpful. Thanks so much.
Sure. Thanks, Jesper. I'll let Søren talk about the market share potential and then Claus on the EBIT.
Yeah, thank you very much, Jesper. So yes, I can also say that when looking at our business case, that is driven by a combination of both market share gain and market expansion. And as I alluded to before, our ambition is to become a market leader in the anaphylaxis market in Europe and also in other markets. And then there are, of course, upsides to the potential that we have outlined.
Claus, maybe on EBIT?
I will. Thanks, Jesper, for the question. Looking at the EBIT margin going forward, we are keeping to our long-term financial targets and what we are seeing here. You are right in your assumptions that this is a product that is fitted very well into our, you can say, current cost structure, meaning that we have sales channels. This is, in the beginning, mostly focused on Europe and Canada. We already have people on the ground. We have the organizations. We have the competencies. Of course, we are now, over the next couple of years, going to invest into this. We want to make sure that this product serves the investments that it entails and that we can drive the sales forward and make this into a commercial success also. So that, of course, means that the sales and marketing cost over the next years will increase.
And we, of course, will make sure that we invest more significantly here in the beginning to make it a success. And then over time, the sales and marketing ratio to overall sales will then go down year on year and then add more and more to our total EBIT margin. That's correct.
Yeah. So maybe, Jesper, just to add to what Claus is saying, I think what's been a driver in this case and what we really like is the fit with our existing sales channels and with our existing infrastructure. So we really believe that we can both utilize what we have and then, obviously, to Claus's point, also continue to invest and then hopefully see a positive halo effect across the portfolio. All right. Did that answer, Jesper?
Did that? Thanks so much.
Thank you. Ladies and gentlemen, just a final reminder. If you would like to ask a question, please press star and then one now. We'll pause a moment to see if we have any further questions. We have a follow-up question from Martin Parkhøi of SEB. Please go ahead.
Great. Thank you very much. Yeah, just a follow-up question on what happens in situations? Can there be any reasons for not being able to use the nasal administration if you potentially have a cold or other thing like that? If that would be the case, would that then be necessary to carry both an injection and a nasal spray at the same time at home?
Thanks, Martin. Søren, do you want to?
Yes, you could say Neffy is approved on the same basis as adrenaline auto-injectors. So it is truly a substitute. So there are no, you could say, concerns in that case. Nothing in the label on that. Are you still there, Martin?
I'm here. Thank you, Sir.
The next question we have is a follow-up from Jesper Ilsøe from Carnegie. Please go ahead.
Thanks so much. Just a question on the next indication under this collaboration with ARS Pharma. Can you just explain a bit more the potential in that market and also whether or not the phase 2b study is a high-risk study or whether it should be pretty plug and play to get the decent data there? Thank you.
Let me start out, Jesper, and then Per, you can supplement. I think the short answer is urticaria is an interesting area. It's also a new area for us. So we've done some preliminary market research that has indicated that this is a very interesting market. We've been looking at urticaria for a number of years, and the acute flare is quite an interesting area. So when you take it high level, currently you have around five million people that are affected in Europe on a yearly basis. And those patients are typically symptom treated with antihistamines or Xolair, so a biologic anti-IgE antibody. So the problem is this is not solving, and hence there is a need for new and other solutions.
This is where the adrenaline fits in quite well and where the initial phase 1 and phase 2 studies have proven to be quite interesting. That's why we found this as a very good fit to what we do. Maybe Per, you can talk a little bit more around autoinjector.
Yeah. Thank you, Peter. So adrenaline has shown its potential in urticaria treatment due to its likely impact on stabilizing the mast cells of the immune system. And what Xolaire has shown in a first phase 2a study is that they've shown effects here where patients reported improvement in both the itching and hives. So now they need to go into a phase 2b study in 2025, and that is expected to be followed by a phase 3 study. So we are looking towards 2028 before this approval can come through. Whether it's plug and play, I mean, nothing in clinical development is plug and play, but at least we have good early indications here from their initial studies in this field. Currently today, the majority of people who have urticaria, they are treated with low doses of antihistamine, then step up in antihistamines.
For those who are not responding, they go on to treatments with omalizumab or Xolair. Still in that patient population, we do observe patients who have symptom breakthroughs. Here we believe there is a potential to help these patients with symptom breakthroughs, helping them in the acute phase of that with low doses of adrenaline. That is what we are going to, and ARS is going to investigate in the future clinical development program. Quite an exciting new indication area.
Thank you. Ladies and gentlemen, at this stage, there are no further questions on the conference call. I will now hand back to management for closing remarks. Please go ahead.
Excellent. Thank you very much, everyone, for all the good questions. If you have follow-up questions, please do not hesitate to reach out to either one of us. With that, we wish you all a good day. Thank you. Goodbye.