Good day, ladies and gentlemen, and Welcome to the Hikma Pharmaceuticals R&D Spotlight series, Respiratory, Nasal, Semi-Solids and Liquid session. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. If you wish to ask a question, we ask that you please use the raise hand function at the bottom of your Zoom screen. Instructions will also follow at the time of the Q&A. Participants can also submit questions through the webcast page using the Ask a Question button. I would like to remind all participants that this call is being recorded. Questions will follow after the presentation. I will now hand over to Susan Ringdal to start the presentation.
Good morning and good afternoon, everyone, and Welcome to the first of our series of spotlight events that have been designed to help the capital markets understand our R&D capabilities, our vision, and how we will deliver it. We will cover why now is the time for Hikma to increase our R&D spend and how this investment will deliver growth and value over the medium to long term. Today, we are joined by Hafrun Fridriksdottir, who is our global head of R&D, and she will give a group level overview of how our R&D organization is set up, and that will be followed by a deep dive into our respiratory, nasal, semi-solids, and liquids platform with Chris Edlin, who heads up that platform. There are some supplementary slides that we will have available on screen and also on our website.
Before we start, I would like to remind you that any forward-looking statements or projections made by Hikma during this call are made in good faith based on information currently available and are subject to risks and uncertainties that may cause actual results to differ materially from those projected. For further information, please see the Principal Risks and Uncertainties section in our latest annual report. With that, let's dive in to our first conversation with Hafrun. So Hafrun, welcome. Thank you so much for joining us today. It would be great if we could just kick off with you giving a brief introduction about your background and maybe going right up to why you decided to join Hikma.
Yeah. Thank you, Susan. As Susan mentioned, my name is Hafrun Fridriksdottir, and I have more than 30 years of experience in the pharma business. I am a pharmacist by training, and I have a PhD in physical pharmacy. Most of my career I have spent in R&D. I worked across multiple pharma companies, both small and large one. Probably my biggest R&D organization was around 5,000 - 6,000 people. I have been leading teams which have been developing all kinds of products, including branded product, both small molecule and also large molecule, meaning biologic. Also led team which have been developing biosimilars and, of course, last but not least, the generics.
I probably spend most of my time in leading teams which have been developing generic formulations, and that includes all kinds of formulations, both covering what we are covering today, I mean, semi-solids and liquids, nasals, inhalations, injectables, both simple injectables and also long-acting injectables. Last but not least, also solid orals, both immediate release and extended release, delayed release. So I have quite a broad experience in R&D and very happy to take over this R&D organization for Hikma a year ago.
Fantastic. Thanks for that, Hafrun. I think clearly we can all understand why, having joined as president of Hikma Rx, we reasonably quickly put you in charge of our global R&D function. Can you just talk about what changes you've made since you took over the R&D function?
Yeah, of course. Happy to do that. As I mentioned, I took over this organization around a year ago, slightly less than a year ago. Before I took this organization over, it was basically located within the different divisions. Rx had their own R&D, MENA had their own R&D, and the injectables had their own R&D. But we decided when I took over this organization that we would like to establish a global R&D organization, which is more specialized, focused on more specialized tasks, and that's why we set it up, as you can see on the screen here. So we have three different main platforms. The platform which we are going to talk about today is the respiratory, nasal, semi-solid, and liquid platform, which is led by Chris Edlin, and we will hear from him as well later in the call.
Majority of his team is located in Columbus, Ohio. Then we have the solid oral platform, which is led by Jaber Othman, and majority of his team is in Jordan. Then we have the injectable platform, which is led by Zdravka Knežević. A big portion of her team is in Croatia, but she also has a team in Portugal, in Cherry Hill, and in Jordan as well, and then smaller teams in other MENA countries. To support those three platforms, we have the cross-functional R&D operation team and also regulatory team. So far it has been working quite well. We have been focused on, since we set up this organization, we have been focused on selecting more of a global product. So each and every market is involved when we are selecting product, which has been quite important for us.
Of course, if there are interesting opportunities for individual markets, then we still, of course, develop product for those markets. We are more focused on global product than we were in the past.
Thank you for that. Clearly, there has been a big change in how we have been structuring the team, but we have also talked a lot about a material change in the amount that we are putting in R&D. Maybe you could just quickly talk about why now is the right time for Hikma to be making this material change in the amount that we are investing in R&D.
Yeah. As I mentioned earlier, there is a lot of opportunities out there. There is a lot of opportunities within those product or platforms which I mentioned earlier. We have been identifying exciting opportunities in all three platforms. Chris will, of course, talk more about the semi-solids and liquid and inhalations and nasals. For example, for the solid orals, we are more focused on first to file, first to market opportunities than maybe Hikma was in the past. You will hear more about this later on also from Jaber, when he present the solid oral. There is a lot of opportunities which we are going after now.
Yeah. It is obviously very encouraging to hear that there are so many good opportunities to go after. Perhaps you can talk a bit about how you think about returns on the spend and therefore how do you select the products that we will actually put into the pipeline?
Yeah. Return on investment is, of course, very important for Hikma and for any other pharma company. That's, of course, a big thing when we are selecting our product. We have quite a sophisticated product selection process, dedicated portfolio, and product selection team. This team, they work very closely with the commercial team, with legal, with finance, et cetera, and of course, with R&D team as well. We have an NPV model, which we take each and every product which we select, new product which we select for development through. We decide, of course, to go after product based on their value, based on the return on investment. Then we take them through product selection meetings, and the executive team is part of those meetings. So it is quite a thorough process which we go through when we are selecting product.
In addition to that, as part of how the product is progressing after it has been selected, we have quite a sophisticated stage system, meaning that when the product comes to, for example, the next phase of development, we take it back through this NPV and IRR calculation just to make sure that the value is still there. If the value is not there anymore because, for example, there is a new competitor on the market, then we don't hesitate, of course, to cancel the product, because that's a very important part of this process, is to make sure that we are focused on the most valuable product and we take those forward. But we don't hesitate to cancel if that's what's needed.
Yeah. That makes a lot of sense. I guess, obviously, there's a lot of work that's going into the product selection, and as we talked about, a lot of investment. But ultimately, we have to have some confidence that we can be successful with these projects. Could you talk a little bit about what gives you confidence in our ability to succeed, especially since we're working across a number of different pillars?
Yeah. Maybe I can start with talking about the strength of the organization. I strongly believe that this setup make sure that people are more focused than maybe the team were in the past. So this is absolutely the right setup for the organization because the teams are more specialized, they're more focused on the individual tasks. We have a very strong team, and we have been strengthening that team over the last two years or so. We brought in people with a strong background and strong knowledge. Chris, for example, he joined from other respiratory organization around a year ago or so. As I mentioned earlier, you will hear from him later on this. Then Zdravka leading the injectable teams. She took over her role just recently. But we basically took over quite a strong team with the acquisition of Xellia around a year ago as well.
But that team was specialized in developing ready-to-use injectable formulations. But we have also been adding more talent to that team over the last few months. That's going quite well. I strongly believe that we have the right team. In addition to that, I don't really need to talk about the solid orals because that team has a proven track record both for the MENA market, for the U.S. market, and they have been doing very well. We have also seen, of course, improvement in submissions, but that's not necessary. It's not about submissions in the end of the day, it's about approvals and being able to launch a product. We have already seen a lot of progress, and I'm very happy with the team, and I have a full confidence in that they will be able to take this organization forward.
Fantastic. Maybe just to wrap up in your section, we obviously have three of these events planned. Today is the first one. What would you like the key takeaway to be from these sessions?
When I came up with this idea, I was very happy to see that because I think it is very important that investors, they know more about what the R&D team in Hikma is doing, and so that's very important for every pharma company to show that R&D organization is working very well, because that's, of course, in the end of the day, the bet and the better for the organization. And that's, of course, to support the future growth of the company. We are not trying to tell investors what numbers they should be putting into their financial model. But of course, with those sections, I hope that investors will see that we have a strong team, and we are making good progress, and we are really focused on developing the right product for the markets which we are operating in.
Fantastic. That's very clear. Thank you very much. Now let's move over to Guy, and I will let Guy introduce Chris. Thank you, Hafrun.
Great. Thank you, Susan, and thanks, Hafrun. Before we introduce Chris, we are just going to run a very short video which was shot at our Columbus site where Chris and his team are based. If the operator could please run that now. Thank you. Okay. Chris, thank you so much for joining us today. It would be great, as Hafrun did, if you could start off just by introducing yourself, giving us a bit of detail on your background, and then also what drew you to join Hikma.
Sure. Thanks, Guy. Like Hafrun, I have got roughly 25 years experience in the industry. I started life as a chemist. I have a degree and a PhD in synthetic organic chemistry from the University of Durham. I picked up an MBA along the way, too. I worked for several large multinational pharma companies in discovery, with a big chunk of that in respiratory discovery. I also ran a startup company in South Africa for about five years. I was elected as a fellow of the Royal Society of Chemistry, plus I have got more than 40 peer-reviewed publications and patents to my name, too. Prior to joining Hikma about two years ago to the day, actually, I ran a respiratory CMC discovery site for another large generic organization in Ireland. What drew me to Hikma? A couple of things, primarily. Firstly, their commitment to fund complex combination products.
They take a long time, so having that commitment to take those through selection, R&D, through to commercial, it takes that commitment, and I was really impressed by that during the recruitment phase. Secondly, and most importantly, I think co-location of the R&D teams with the site of manufacture is really important. Combination products are called that for a good reason. We need to develop them in combination not only with the R&D team, but the operations team that are going to deliver them to patients ultimately.
Brilliant. Thanks, Chris, and we will talk more about some of those large complex combination products in a bit. Before that, maybe for those less familiar with it, could you just explain what sits within the RNSSL platform? There are four categories within it. How does that work, and how is your team set up?
Yeah, sure. Respiratory covers orally inhaled products like dry powder inhalers, pressurized metered dose inhalers, soft mist inhalers, nebulized products. In general, they are the largest markets with the highest barriers to entry. They are the ones that we are committed to developing products for. Nasal products cover both multi and single dose sprays, and we are moving those forward using a number of regulatory pathways. I will talk about those a little bit later too. The ANDA and the branded 505(b)(2) route too. Semi-solids, creams and ointments. Those programs are mainly prosecuted in sites in our MENA region. Then finally, liquids. This covers both oral solutions and suspensions, and that includes controlled substances that we execute in Columbus. Overall, the team is organized around three functional areas.
We have a strong analytical group, a formulation and process development group, and a clinical group, and they are supported locally by device engineers, human factors scientists, and regulatory affairs that are all co-located in Columbus.
Great. Thanks for that, Chris. Then coming to Hikma more generally in terms of what makes Hikma stand out in this field and what capabilities do we have to justify this as a platform in its own right and make it a defensible one?
I think we have got a demonstrable track record in developing and commercializing a number of complex combination products. You can look to our generic Advair success story and fluticasone propionate multi-dose nasal spray that are sustained in the market. Developing these combination products requires a unique combination of skills across all of the functional areas in R&D, so analytical formulation and clinical development. We need to make sure that we understand not only the drug product but how that drug product interacts with the device, too. I think we have built a team that is capable of delivering that.
Amazing. Before we dive into a few of those assets, maybe at a high level, I know Hafrun and Susan touched on this as well, but maybe you can talk from your platform's perspective as to how you go about product selection and shaping the broader pipeline.
Yeah. I think Hafrun outlined how we look at that holistically as an organization, and that trickles down into my organization, too. We routinely use NPV, return on investment, and IRR as a way to prioritize how we allocate resource to projects. That's a routine part of how we operate. We do that through frequent and regular stage gates, but not only look at the business case, but also at the probability of technical and regulatory success, too. It's a dynamic process. It's kind of embedded in the way that we think and talk about programs at a leadership level in the site here.
Great. Thank you. Onto some products, and maybe some of the larger opportunities. One that we've spoken about recent and had some recent news on around filing is our intranasal epinephrine. Could you just talk a bit about that product itself, why it's an interesting opportunity? After that, we can go a bit into the 505(b)(2) pathway that we used on that product.
Yeah, sure. We communicated externally that intranasal epinephrine has been filed and accepted for review in the U.S. The same story in the E.U., where we filed via the decentralized procedure. At the end of last year, we filed in the U.K. to the MHRA. We've also filed in Canada, Jordan, and Saudi Arabia. We're really excited about this product. We believe it has clear advantages. Unfortunately, I'm sure you'll understand this, we can't share the actual data right now whilst it's under regulatory review. We expect feedback from the FDA in the first half of 2027, but unfortunately, we can't guide on exact launch dates at this time.
Thanks, Chris. I mean, we obviously look forward to communicating more on that product down the line, but maybe I mentioned the 505(b)(2) pathway there, as did you. We have a generalist audience as well as pharma specialists on the line, but maybe for the more generalists, could you help explain what that pathway is? It's a U.S. specific one, but how we've gone about developing the nasal epinephrine spray, and mainly focused on the importance of that 505(b)(2) route.
Yeah, sure. I'll do my best. I think the traditional way of branded companies developing new chemical entities, NCEs, is to follow the NDA pathway where companies would generate all of the safety and efficacy data through the discovery preclinical and then phase I through III stages. The other extreme of the process is the ANDA, the abbreviated NDA process, where we, as a generics organization, demonstrate equivalence to a brand, and then we rely on the safety and efficacy data that, say, the FDA hold on file. We work using the, excuse me, the product specific guidances that the FDA publishes. 505 sits between those two. It's companies often repurpose routes of administration, and they leverage the established safety and efficacy of the molecule. Epinephrine is a great example of that. It's been around for more than 100 years.
The safety and efficacy has been proven and well used, and we've found a way to reformat that into a dosage form that's going to be more convenient for patients.
Could we leverage that 505(b)(2) pathway for other potential products in the pipeline in the future?
Absolutely. We have a number of activities going on in-house where we are looking to synergize with franchises that we're going to build around the epinephrine asset, and also looking for adjacencies to that, but also looking to leverage the internal manufacturing capability too. We have a strong track record in commercial contract manufacturing for nasal products, and we're looking to utilize our expertise to develop new programs where, for example, the nasal route offers unique advantages in terms of onset of action.
Brilliant. That makes a lot of sense. Maybe we can now move to respiratory. We've messaged that we're looking at Ellipta, which is the sort of next generation of inhalers. Generic Advair has been a great success for Hikma. People will be familiar with that from us for a long time now. It took a long time to develop, but it's been a good product for us. To that end, can you talk a little bit about Ellipta, and our other respiratory projects and what's going on in that field?
Yeah, absolutely. Excuse me again. We've made great progress with the Ellipta program. We've selected a device partner, and that relationship is working extremely well. We have formed a great team around moving that forward. We've generated not only in vitro, but human in vivo data that gives us huge confidence that it was the right choice. We're moving forward with establishing commercial manufacturing capability in Columbus. There's a lot of synergy with the generic Advair program, too. For example, the first step in the process is, we'll use the same equipment that we use commercially for the Advair program. For later steps, we use slightly different equipment, but the same vendors. We have established relationships with those too. We'll leverage that.
In terms of the other dosage forms that we're looking at, we've selected external partners to work with where we don't have that capability in-house to manufacture or where it's niche or specialized device engineering requirements.
Great. You touched on a little bit there, but it is obviously clear that partnership is an important element of some of these projects. How do you decide between developing in-house, licensing a device or partnering?
Yeah. I think we have taken a very common sense approach to that. Where we have got capability in-house, we have leveraged and amplified that. Where we do not have that capability, we have sought established partners in the areas and built co-development programs with those people. It is a bit of a spectrum of activities, really. With the generic Advair, it is predominantly in-house with some device expertise externally, whereas the pressurised metered dose inhalers is predominantly external through co-development activities.
Okay, great. Going back to, again, a topic that was raised earlier, but on returns, if you take a project like Ellipta, this is a long-term project. How do you think about return on investment, when you are making decisions today for something that will come a long way down the line? How can we be confident in future success there?
It is a very similar answer to before. We monitor the market. We have a robust governance procedure where we routinely check the business case. We routinely check that the NPV of a program is aligned with our expectations, and we stage gate investments so that we de-risk that for the company going forward.
Yeah. Great. I guess that stage gating is a key part of everything.
Yeah.
Artificial intelligence, maybe just quickly touch on that. It's obviously a big topic, and it would be great to understand how you and your teams are using AI in your day-to-day.
Yeah. So we've deployed it widely through R&D in Hikma. We see it primarily as a productivity tool. It's really freed up scientists' time to do science rather than more administrative tasks. So we've found ways to automate report generation, data aggregation, and analysis. It doesn't take away the QC step of scientists doing the science and looking at the data, but it really has freed up our time. So over time, I think we'll be able to move more projects forward with the same amount of resource, process more data, that kind of thing.
Brilliant. Thanks for that. I know that's the case across much of the Hikma group in terms of how we're deploying AI. So finally, we'll go to some Q&A from the audience in a moment. But before that, Chris, it would be great to hear what you feel investors and analysts should take away about your pillar from these events.
Mainly focused on projects and people. I think we've built a balanced portfolio of high-value, complex products that will take a longer time to deliver, offset with some near-term wins around, I guess, the less complicated dosage forms. That's one thing. The second thing is the people. I think it's essential that we build a team and a culture that is able to deliver, and we've spent a long time, the last couple of years, really building that team, and I truly believe that we've got the technical expertise to deliver these programs to patients.
Fantastic. Okay, thanks very much, Chris. With that, I'm going to hand back over to the operator, who will initiate the open Q&A session.
Thank you. We will now start the Q&A. If you wish to ask a question, please use the raise hand function at the bottom of your Zoom screen. As a reminder, participants can also submit questions through the webcast using the ask a question button. We'll pause a moment to allow the queue to form. Our first question comes from Zain Ebrahim from JP Morgan. Please unmute your line and ask your question.
Hello. Zain Ebrahim, JP Morgan. Thanks for taking the question. I'll ask one, which is just on the Ellipta portfolio development. I think you mentioned filing in 2029 in terms of expected timelines, but could you just talk through maybe some of the experience with generic Advair that you had? I think that took a little bit of time to file post some of the FDA feedback. So how you've incorporated some of the experience from the development from Advair in your thinking for Ellipta?
That's a good question. A couple of things there. One, starting at the AI level. For example, we've looked at all of the deficiency responses that we received from the FDA through the Advair review process, and we've used AI to do a lessons learned exercise there so that we can incorporate a number of those learnings into our development program. That's the first thing. Hikma had to repeat some of the clinical trials for the Advair development program. The product specific guidances has changed now for these kinds of programs, so there isn't a requirement to do a clinical endpoint study. The burden's changed slightly in terms of the methods to demonstrate equivalence to the brand. It just requires a different set of technical expertise, and we're well-placed to deliver on those at the moment, I think.
Thanks very much.
Thank you. Our next question comes from Giang Nguyen from Citi. Please unmute your line and ask your question.
Hi, guys. Giang Nguyen from Citi, and thanks for taking my questions. I have two, please. I think the first one is, Hafrun, thanks for providing the color around the product selection framework. I was wondering, how does Hikma thinking around returns on R&D and capital discipline, such as the value metrics that you mentioned, how does it differ today from a year or two ago? That was my first questions. My second question is for Chris. Thanks for providing us the details around the Ellipta program. Was wondering if you could provide a couple of comments around the other two programs. That'd be Respimat and the pMDIs program. Thanks.
Yeah. If I start with regards to return on investment and around the product selection. We have, of course, some specific limits. For example, if we are selecting a global product, what does the NPV needs to be? What does the IRR needs to be? I'm not necessarily going to exactly what those numbers are, but we follow that, of course, strictly. But for example, if we are developing product for a smaller market, then we have different NPV and different IRR if we are only focused on one, two markets. And we follow that product quite how it was done in Hikma in the past. I don't have a detailed review on that, but I know that we at least we have a very strict process to this which we follow quite rightly. Chris.
Yeah. Just to recap then. The questions were on the Respimat soft mist and the pMDI programs, correct? Respimat, I think we are slightly delayed, compared to the last time that we communicated that from a submission point of view, but we don't believe that it will materially affect the launch timings, which are still focused around patent expiry. Just to note, it is a highly complex device, and there's been some technical challenges, but again, I think we've resolved most of those. But it's resulted in some delays to the submission timing. The pMDIs, we've selected two areas that are high volume from a pMDI perspective. We are still in the final stages of finalizing that contract with the third-party partner.
Thank you. Our next question comes from Sebastien Jantet from Panmure Liberum. Please unmute your line and ask your question.
Thanks for taking my question. Just, I guess, a couple of quick questions. First of all, if you're going for more global programs, does that mean we should start thinking about the R&D pipeline focusing on slightly larger products? And I guess within that, how do you manage, therefore, the specific risk of having a lot of eggs in one basket, so to speak?
Yeah. If I can start. I think Hikma has, of course, been developing global programs in the past as well. But the reason for why I talked about selection of global programs, why that is critical both for the R&D organization, but also for the commercial organization, is that we take all the requirements from all different countries into consideration when we start the program. The tendency was maybe a little bit to start with one market and then having maybe to repeat some of the work which was done to adjust to other markets. But now our focus is really to take into consideration the requirements from all markets when we start those programs. That's the main difference, which I would say that what we have implemented over the last year or so.
I guess the other part of the question was just to understand then how would the concentration look. Should we be thinking about you launching a small number of large peak sale products or a much larger number of small peak products within the kind of the portfolio?
Yeah, sorry, I missed that part. No, I think it will be mixture of both. For example, if I talk about, for example, the solid orals, which many of them are not necessarily huge products, but if we approve them for development for all markets at the same time, then clearly, of course, the cost of developing those programs is less. But then we have, of course, larger programs, as mentioned, for epinephrine is an example where we have in most of the market which we are operating in. I would say it will be mixture of both, and I don't want to lose those smaller opportunities, which may be cost less but still give us a significant return on investment.
Brilliant. Thank you very much.
Thank you. Our next question comes from Kane Slutzkin with Deutsche. Please unmute your line and ask your question.
Thank you. Morning. Afternoon. We are seeing more generic companies shift, I guess, towards more complex products. As that is happening, are you seeing competitive intensity rise in those areas in respiratory or nasal? Given the long lead times, how do you actually assess what the competitive landscape and returns might look like by the time the product actually reaches the market? Just following on from that, is submissions the right metric that we should focus on, or should we be increasingly looking at the value or complexity of the products that are coming through the pipeline?
Do you want me to have a go at that, Hafrun, or do you want to. I guess the simple answer is in terms of managing expectations, we talked about the way that we govern projects and we stage gate. We review business cases frequently, so we make sure that we are still on the correct trajectory. In terms of whether submission is the right metric, it is probably a little easier to forecast submission rather than launch because there is always ambiguity when you file with the regulatory authorities. To try and offset that ambiguity, we are investing in improving our right first time metrics, using things like AI, making sure we learn from lessons in the past to increase the robustness of our filings so that we can more accurately forecast when we are going to get approval. Does that answer your question?
Yeah, sort of. Thanks.
Chris, maybe just going back to the first question around the competitive intensity. Maybe you could, I don't know, I think maybe Advair would be a good example, but maybe you could talk a little bit about how competition has evolved on Advair and maybe what you would take from that, thinking about or using that to think, what do we anticipate in terms of the potential competition for the Ellipta products?
Yeah, I think it's very difficult to say exactly how much competition that we expect. But compared to solid orals, for example, the number of companies that are prepared to commit to the spend and timelines of these programs is significantly lower. I think that in terms of market share, ultimately, it's going to be higher than some of the, this is not the right word to use necessarily, the simpler dosage forms like solid oral dosage.
If I may add a little bit about Advair, because Hikma, of course, launched Advair probably around five years ago or so, and so far it has been three or four competitors on the market, and it took a long time for many of our competitors to take it through the final approval. But surprisingly, actually, it was two approvals this year. I think for both those approvals, it took those companies up to 10 years to get to approval. So, that's of course demonstrating how complex those programs are. Also you really need to have the right experience, you really need to have the right team, you need to have the right capability in the organization to be able to develop them and, of course, being in the first wave of launching them.
That's something which we absolutely believe that we have in our organization or Hikma organization today, so.
Yeah. I'm just-
Sorry, go ahead, Chris.
I was going to say, it's not only the skills in developing, but it's also the skills in manufacturing consistently to high quality too, which isn't easy. We shouldn't underestimate that aspect of it too, and again, something that I think Hikma's really demonstrated over the last five years with Advair. Sorry, Susan.
Thank- No problem. I wanted you to make that manufacturing point. I think it's a good one.
All good.
Thank you. Our next question comes from Miles Dixon with Peel Hunt. Please unmute your line and ask your question.
Thank you. Yes. We have heard lots on the benefits of centralizing R&D. I was wondering if I would just ask you, Hafrun, given the last, or certainly the last year, have there been any, or what was the biggest challenge really in implementing this new structure and approach around R&D? Also relatedly to Susan's point about competitive intensity, you talked about identifying products and opportunities around patent expiry, et cetera. But they then cancel or can cancel, I should say. What is the frequency in which that happens, and how has that changed over the last few years? Thank you.
Yeah. What was the biggest challenge in establishing the new organization? It was, of course, first of all, to decide did we have the right team in place and where did we need to add additional capability. That is something which we have been working on and has been going, I would say, quite well. I strongly believe. It is developing programs as we are developing is so dependent on having the right capability and right experience in place, and I strongly believe that we do have that now. Was it extremely challenging? No, I would not say so. It has been going quite well. Now I am trying to remember the second part of your question. Yeah, how frequently does it happen that you need to cancel product because competition has changed? It happens quite frequently, to be honest, and especially for maybe the more easier programs.
We really try to be well aware of trying to kill programs early if they need to be killed. If we see that there is an extreme competition coming in, then we try to do that as quickly as we can. It happens mainly for the programs which we are developing for the U.S. market, because that's of course where the competition is probably the highest. It does not happen very frequently for programs we are developing for the MENA market. But it happens. I cannot really give you any statistic, but it happens. I think that's very healthy. That's how things should be treated. That's how things should be done.
Thank you. That's very helpful.
Thank you. Our next question comes from Beatrice Fairbairn with Berenberg. Please unmute your line and ask your question.
Hi. Thank you for taking my question. You have highlighted enhanced cross-functional synergies and knowledge sharing across platforms. I suppose could you give us more color on what is different now versus before the kind of centralization of R&D? I am conscious you cannot share specific data, but more generally, what are your expectations for competition in the epinephrine market when considering the nasal platform approach that you have taken? Thank you.
Yeah. If I can start, Chris, then I will give it over to you. I think what's different now, as I think I mentioned when we started this meeting, is that we have much more specialized team, teams which are specialized in developing, for example, inhalation product, in nasal product. They are all sitting together and working on similar formulations. Same for injectables. They are all sitting together and working on similar formulations. People are learning from each other. They are not trying to be experts in each and every area, but they are much more focused, and I think that's very beneficial, and that's something which I have done in my previous organizations as well. Synergies between the three platforms. We have, for example, one harmonized extractable leachable lab, which is supporting all the three platforms.
We have harmonized nitrosamine labs which are supporting each and every platform. Regulatory team is supporting all the platforms. R&D ops is supporting all the platforms. We have seen a lot of synergy in this setup as well. Chris, I'm going to give it over to you with regards to epinephrine.
Yeah, sure. Just to note that we were not going to give commercial guidance on this call, but I guess what I'm going to say is caveated to some extent. It's a highly competitive space, the epinephrine market. There's established gold standards in terms of the intramuscular dosage form to deal with it. But we believe that our product is differentiated from that and others that are being developed and are close to approval. However, we can't make any claims because the product is under regulatory review at the moment, and unfortunately, you're going to have to just wait and see for when the label is published. But the commercial team have got great plans to move this program forward. Sorry.
Thank you. As a reminder, if you would like to ask a question, please use the raise hand button at the bottom of your Zoom screen. We'll pause a moment to allow for a queue to form. There are no further questions on the webinar. I'll now hand over to Guy Featherstone to address the written questions.
Thank you very much. Actually, there are two questions which have been submitted, which are both on nasal epinephrine. Chris, I think you actually just covered the point. Just for transparency, Victor Floc'h at BNP Paribas asking about commercial ambitions on nasal epi and competitive differentiators, and Christian at Stifel again asking about observations on the competition, the ARS products and how that's performing. Unless there's anything else to add, Chris, I think you covered it off just then. Sorry, I will hand back to you.
Maybe just one thing. Just to give people some insight into how the process went with the U.S. regulators, the FDA. At every stage through the development of the program prior to submission and acceptance for review, the FDA saw the data that we generated. They approved protocols before we executed the next round of clinical studies and saw the data from those. The FDA have been along this journey with Hikma, too. I think that's highly encouraging.
Thank you.
Guy, if you want to talk about the neffy and the competition, I do not think if it is really appropriate to address that here, but
No, I don't think.
No.
As Chris said, we will talk more about this product as we go through the process with the regulators and when we have more news next year.
Yep.
There are no more written questions.
Great. If I just may add on epinephrine that we are not the first filer on nasal spray for epinephrine, because neffy was of course launched probably a year ago in U.S. and in Europe as well. But we believe that being a fast follower is actually very beneficial because, hopefully they will be very successful in building the market for the nasal spray for epinephrine, which we believe is preferred or should be a preferred dosage form for the product moving forward.
Thank you, Hafrun. I think that is a great note to end on. On behalf of the whole Hikma team, I would like to thank everyone for joining the call today. Just a reminder that our next event will be covering the solid orals R&D at Hikma, and that is scheduled for Tuesday, November 24 at 2:00 P.M. GMT. Thank you again. We hope you found this valuable, and we look forward to seeing you all then.
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