Okay. It looks like we have everyone in the room, and we're ready to kick off.

Thanks, Layan. So we're ready to go. I thought we would just open it straight up for questions and answers. So if you have a question, let us know, and we'd be happy to kick it off. A - Layan Kalisse: So this is just going to be the usual setup. [Operator Instructions] So we already have our first question from Pete Verdult [Citi]. Pete, please go ahead, ask your question.

Yes. Peter Verdult, Citi. Two questions. Just firstly, maybe just starting with Branded actually. Great start to the year. You're still saying mid-single-digit growth basically means that you're going to be declining in the second half. I know you talked about some pull-through, but can you just help us understand, is there any sort of upside risks growing Branded versus the guidance, not just near-term but the outlook in terms of improving the top line and margin? So just a bit of a walk-through on Branded would be helpful. And then secondly, just the step-up in Generic profitability, just can you walk us through the key drivers and perhaps update us on Advair and your thoughts there? It would be appreciated. Thank you.

Yes. Thanks, Pete. So let's start with the Branded. So first of all, very, very pleased with the branded performance in the first half of the year. It really are the three Tier 1 markets that are performing extremely well: Saudi Arabia, Egypt and Algeria. The key reasons why we did the double-digit growth in the first half and we are maintaining our guidance in constant currency at mid single-digit growth is simply that we are now expecting that the year will be more equal. What that means is, in a usual year, we do about 46-54 or 47-53, but based on what we are seeing today in the market, we're expecting more of an equal first half versus second half. Let me explain maybe the reasoning for it. So there were two markets that had a very low comp a year ago which performed extremely well this time around. So Algeria was in a turnaround situation in the first half of 2020 and did an outstanding job in first half of 2021. We also changed our commercial model in Algeria, so it's more equally distributed because Algeria has been much more back-end loaded in revenue versus first hand. So it will be equally distributed the performance in the first half and the second half in Algeria. But Algeria was a turnaround which helped the growth in the business. And the second market which we tend not to talk about was Sudan, which had a very little or hardly any sale in the first half of 2020, but did very well this year. We have the FX challenges and other things in Sudan, which Khalid will talk about later. But overall, these were the two markets that have an outstanding comparison versus the comp we had in 2020. In terms of the third thing is – are the pull-through or the pull forward was a little bit in Egypt into the hospitals and also in Saudi Arabia. We saw a little bit of pull through in these tenders in both Egypt and in Saudi Arabia. So we reduced the expected sale in the second half of the year versus first half. So net-net, really pleased with the performance. But overall, still our expectation would be in line with our original guidance of a mid single-digit. I think just overall for MENA, it is a really good sign because both the market seems to be getting back to pre-pandemic situation. What I mean by that is we are selling well of the chronic therapies, but also, there is a significant improvement in the sale of anti-infectives. Anti-infectives have been a little bit of an indication how we are doing in the pandemic because last year, we sold very little – or maybe not very little. We sold a lot less of anti-infectives than we usually do. And we see a step-up in that. And now when we're getting the sales force back on the street, we see also an increase in the chronic medication. So that's the key reason why we are still maintaining the guidance mid single-digit. We feel good about the market. Hopefully, we are on the way in the step-up you talk about that we can continue the growth to have a little bit better than the mid single-digit. We're still very pleased with the profitability, but we don't guide on profitability in the MENA region, as you all know. In terms of the Generics, I think overall there, very pleased with the results, both top and bottom line. I think on the top line, the performance is over our expectation. It has to do with a strong underlying business but also the performance of the new launches. And that doesn't include really generic Advair because we have a very little generic Advair in the first half of the year. We are expecting basically the replenishment orders to come in the second half of the year. As we mentioned in our prepared remarks, we would expect that maybe later this month, you will start to see in IQVIA more of the volume of the replenishment orders that we would see in the market. But in terms of Zortress, in terms of Afinitor, in terms of icosapent, we did extremely well. We also have a very tight control on our expenses. We are doing better on the expense line. We also have our cost of goods sold. We have been introducing a lot of secondary suppliers of our API, which has lowered our cost of goods and improved our gross margin. In terms of the balance of the year in Generics, there will be still a more cost in the second half of the year, both on the sales and marketing line and on the R&D. On the sales and marketing line, the key reason is that we launched KLOXXADO earlier this week. That includes 35 new sales reps, but introducing that product to the market. So that is very back half-weighted, that cost of the KLOXXADO launch. And on the R&D, it goes up and down. It's difficult, but for the full year, we expect the second half to be higher on R&D. There will be maybe not exactly as much as we expected beginning of the year, R&D, simply for the reason that we got generic Advair approved or relaunched in end of April of this year, which meant that the Ellipta clinical trials will probably be pushed – some of the cost will be pushed into 2022 instead of coming this part of the year. But overall, the R&D is also second half weighted versus the first half. So – and then last thing just to follow up on Advair you mentioned, very pleased with the pickup. We have had a very good feedback on our device. I hope soon I can give you sample of a device, so you can see how good it is. Good feedback from patients. Good feedback from doctors. Good feedback from pharmacists. But the issue was that there was a lot of inventory in the trade because obviously that our competitors knew that we were coming to the market. So after the initial orders, there have been a lot of burn-down of the initial inventory of our competitors. So the replenishment orders are coming through now basically. So we feel good about the market, excited about the opportunity, and we haven't had any hiccup in the launch of generic Advair.

Thank you.

Our next question is from Thibault [Morgan Stanley]. Thibault, please go ahead and ask your question.

Yes, thank you for taking my questions. On Injectables, very strong performance in Europe. There's a suggestion that contract manufacturing has helped, in particular, remdesivir. I think there is an expectation that these revenues are going to fade away in March and next year at least for remdesivir. So just if you could tell us how much of the growth is sustainable. Could we see a reversal in the second half and in 2022? So yes, European Generics – European Injectables. And then in the U.S., just if you could give us a bit more color on your expectations for the second half in terms of the recovery of elective surgeries. And I think you mentioned that you expect U.S. Injectables sales to grow this year. So just if you could give us some color on this.

Yes. So Thibault, so I think Europe, clearly a really good performance. In terms of remdesivir, we are obviously not calling out the individual contract we have. We have been very clear that that contract will come to an end by the end of this year. We have other contract manufacturing. We have approximately, I think, between just over – between five to 10 different contract manufacturing contracts in the European business. This is not a core business for us. I think I've explained it to some of you. We do this to fill the extra capacity we have. But really, if I didn't have to take a contract manufacturing, if I would have my own products, I would rather do that because that is more profitable. But you are right, this is a contract that will come to an end. For your modeling purposes, remdesivir is equally distributed throughout the year. So it's equal amount in the first half and second half. That's simply how Gilead have ordered the product. The orders are in – we know it's going to by the end of the year. It will not impact Europe in the first half of next year. But we feel good about continuing the business in Europe, both other contract manufacturing, but also the underlying business in Europe is growing double-digit. So the business we have in Germany, in Italy and Portugal are growing double-digit. On top of that, we now have over 30 products approved in France, and we have hired our first employees in France. So slowly and steadily, we will start in the French market. We are also getting our approvals through in Spain but we still haven't kicked off the operation in Spain. And we are also getting some approval in UK. So we feel good about Europe. Obviously, outstanding results, which were impacted by both contract manufacturing but also by the underlying growth of the business that we have in the European market for the Injectable business. On the forecast for the remaining – remainder of the year in the U.S., clearly, in a way we expected the elective surgery is to be a little bit better than we are seeing at the moment. And that has to do, I think, with the Delta variant and other things like that. You see in the prepared remarks and on the slides, we are still about 20% plus down versus what IQVIA called a normal year. They basically have normalized the baseline what to be expected. It's difficult to see. We are hopeful this will improve. We see more and more surgeries coming in. But in our forecast, we see that by the end of the year, we should be at a normal level. It's difficult to understand it because this is hanging on variants and how COVID will play out. But overall, it's about – just about 20% below based on IQVIA at the moment. And hopefully, for the remaining of the year, it will get back to normal. But overall, for the U.S. Injectable business, I'm really pleased with what they did. Yes, we are down versus first half of 2020, but it's a very difficult comparison because first half of 2020 was exceptional year for the U.S. Injectable business. We sold so much COVID-related products, which we are not selling now. And maybe just a 30-second story about it, this has to do with, even though there's an increase in patients going to the hospital, a lot fewer of those patients are ending up in the ICU. And of those patients that end up in ICU, previously, in April of last year, approximately 80% of patients that ended up in ICU and for COVID-related symptoms ended up on ventilators. That ratio now is approximately 40%. In addition, there are a few patients. So this gives you an indication how much less COVID-related sale we are having in the hospital, which I think in a way is a good thing for the overall health care in the U.S. But what is really the tail end that we have seen in the first half of the year has to do with the nine new launches we had. We launched nine products in the market. And in July, we added two products. And on top of that, there have been a little bit of a sketchy supply issue by our competitors. Fresenius has had some issues, not significantly impacting our performance yet, but we are monitoring it. But we have seen probably a handful of products where they haven't been in full supply. And also, there have been a little bit of an interruption in Pfizer but to a lesser degree. So we are monitoring that. That could be a tailwind for us in the second half. But overall, we feel good about the business. Still, the global Injectable is growing based on obviously Europe and MENA. But in comparison for the U.S. business, I really am pleased, and it's in line or even better than my expectation going into the year.

Thank you.

Our next question is from James Gordon [JP Morgan]. James, please go ahead and ask your question.

Hello, can you hear me okay?

Yes.

Great, thanks for taking the questions. First question was just, can you help us sort of quantify a bit the drivers of the H2 margin contraction in the Generics division? Because the low end seems to imply about six percentage points of sequential margin contraction, so that’s about $30 million of combined COGS and OpEx together. And I heard about extra sales and marketing going behind the spray and some higher R&D. So how much of the $30 million is sales and marketing versus R&D if you were to get to the bottom end of that? And how much of it extrapolates to next year? As in if we're thinking about not asking for an exact guidance, but if we're thinking about profitability in 2022, is it going to be more like what you just reported or more like what you're implying for the second half of the year for the Generics division? That's the first question, please. And second one was just on generic Vascepa. Can you update us where are you in terms of supply of API and ability to accelerate that product in the second half? And what does guidance assume happens for generic Vascepa, assuming you don't have much more capacity in the products, flattish? And does it assume profitability improves as you've got more supply? What's reflected there, please?

Very good, James. Thanks for this. So if we talk about the Generic business and what's happening in the second half of the year, so the number one – first of all, I've mentioned before, it has to do with our costs. So the sales and marketing is second half-weighted due to the launch of KLOXXADO, and also, there is an R&D. I can't quantify that exactly for you how much that is. But clearly, we are second half-weighted on the both. But also what is happening is one of our better products that we have had which have been driving growth in the last 14 months is generic Zortress. So generic Zortress got competition from Breckenridge Pharmaceutical last week. So that, for example, it's the competition we are seeing on some of our – maybe three or four of our key products. But we know we have our competitors coming in, which are importing. Zortress extremely well. You can see that IQVIA. Now with a competitor coming in last week, our expectation – and that obviously was a new launch. We were alone on the market. That has an impact on the overall performance of the portfolio. So this is the reason why we see a little bit of reduction in the profitability in the second half which leads to the guidance of 22% to 24%. In a way, I can't quantify it, but it has to do both with the cost but also with competition on key products that you might have seen in the media, in the press release, which we are quantifying into our guidance for the remaining of the year. Nobody expected Zortress to be – we would be a sole supplier of generic Zortress for 14 months. All good things come to an end. We are ready for that. But that is also, as an example coming – impacting why we are reducing the profitability in the second half of the year. How that will affect the next year guidance is impossible to know. We need to see how we are doing with new launches going into next year, impact of other products that we are bringing to the market. I think in terms of R&D, we also need to think about that. How much do we want to invest? I think at a global level – no, not global level, at the Hikma corporate level, we are still maintaining 7% to 8% of revenue into R&D. How much of that we will put into Generics will be the question for next year for that P&L. But overall, I feel we are performing the business in the 20s. As I maintained in February when I guided the Street, I don't know if it was you, James, or somebody else that asked me, is the business performing in the 20s and then the movement is how much extra you want to spend on sales and marketing and R&D? I think that's a fair comment to make. The question is where do we want to have this number to come out in the guidance? And obviously, we will guide for next year – in early next year. In terms of icosapent supply situation, we decided to share with you in the prepared remarks on the slides how the market share has moved since we came to the market. It's exactly as I guided, a very slow increase in market share for our generic version of icosapent. It all has to do with API supply. So slowly, we have been able to take more market share when we have more volume, more API available to us, which we then make into finished products. So our expectation is this will continue towards the end of this year. It will be slow, maybe at the pace that you are seeing in the graph on the – in the prepared remarks. In terms of the competition on icosapent, Dr. Reddy's is in the market. Still, we are not seeing any impact on us because also, the brand has a huge market share, so that really hasn't impacted our market share or our growth in the market. And then, of course, you might have noticed that Apotex got approval for their are thinking about, their launch strategy, if they have API available or what the thinking is there. But at least in our plan, we assume towards the end of the year, we will continue very slow growth in market share based on having every month, a little bit more API available to us to bring to a finished dosage form that we bring to the market.

Our next question is from Max Hermann [Stifel]. Max, please go ahead and ask your question.

Right, thanks for taking the questions. Three if I may. Firstly, just on understanding a little bit more about the dynamics in what you're building in the specs – specialty pharmaceutical arena. Obviously, you've talked about the launch of your nasal naloxone and building the sales force there. You've had it from Mitigare already. Just want to understand what sort of investment you're talking about. And then also perhaps longer term, where you see that? Do you see that remaining part of the Generics business or expanding that more broadly? Or the Generics business will sort of merge and maybe become a bit more dominated by the spec pharma business? And then just two follow-up questions, one, update on Ryaltris, and any developments there? And then on Advair, you talked about how competitors have launched or have filled the channel basically ahead of your launch. I wondered whether that had led to more pricing pressure and your need to maybe be more competitive on price. Just want to understand that a little bit more. Thank you.

Yes. So thanks, Max. So it's a very good thing and we are excited about the specialty. And just as an example, yes, we launched KLOXXADO this week. I mentioned previously the KLOXXADO sales force is approximately 35 people at the moment. 20 – approximately 20 of them are in the retail space, and the other 15 are both medical sales liaison, governmental people, et cetera, et cetera. So that was the investment around KLOXXADO. Very little contribution to top line of KLOXXADO in the first – in the second half of this year. But then obviously, we will guide what we will see in the future in 2022. But excited about this opportunity. We have had Advisory Boards on this product. It is I think an exciting opportunity. It's difficult to quantify. We know Narcan had a really good sale in second quarter. So there is clearly a need for this product coming into the market. We are still maintaining a good sale in Mitigare, especially in volume. The price has gone down because the colchicine tablets are generic at the moment. Remember that the Mitigare is colchicine capsules, but we are still maintaining a fair amount of volume, and we are maintaining most of our sales force to drive the prescription for the drug. So in a way, I think Mitigare has performed better than we expected when the tablets became generic. The capsules are still doing quite well in the market. So the sales force has – we have maintained most of the sales force in promoting Mitigare at the moment. We then have a two eyecare product. We have a brand called ZERVIATE, which is a cetirizine eye product, which we are promoting to allergists. And the reason why we are promoting this, this is just – we are promoting this for our third-party eyecare company. And the reason we are doing this is obviously, it's to utilize our infrastructure and sales and marketing, but also to build a relationship with the allergists before we launch Ryaltris. That has been going well. It just kicked off first half of this year. We are visiting the allergist offices. I think it's a great investment in preparation for the launch of Ryaltris. In terms of Ryaltris, I think Glenmark has been quite open about it. They are now expecting approval in 2022. They have responded to the application. I think they're expecting an inspection soon but they also have filed an amended NDA with the possible third-party manufacturer to be able to supply this product. So there's also both strategy A and strategy B in place for this product. If there's any delay in getting inspection in India is that we expect to have then a third party being able to supply this product. So our expectation of this product is that we will get approval next year. I can't give you more details. I – we simply don't know what the details are, what part of the year, if it is first half or second half. But overall, we have started to invest in this field of the business by doing the cetirizine eye drop promotion to the allergists at the moment. Your question about are we going to keep this within the Generics or is this a big enough business to be a stand-alone, at the moment, I think we get a lot of synergies from the Generics. We are not building an infrastructure of different finance people, different leadership team. So because it's relatively small, we are keeping it within the Generics. We still see the benefit from that. But we keep it open that if this grows proportionally more versus the Generic business, we see the possibility of carving this out and keeping it as a separate business model, but we haven't come to that. And I don't think that would happen in the next year or two, while we are building up the business as we talked about. And then on generic Advair, really, it didn't have to do with pricing. It simply had to do with because we got the approval in December, and then we had to hold our launch due to the pre-approval supplement. I think our competitors pretty much knew that we would be coming to the market. So in their sales strategy, they just filled the channel as much as they could before we came in. So there was a little bit more of inventory that needed to be burned down. The pricing, I don't talk about pricing of individual product, but I can tell you the pricing is in line with our expectations. So it more had to do with timing than really the pricing in the market.

Our next question is from James Vane-Tempest. James, please go ahead and ask your question. James Vane-Tempest: Hi, good morning everyone, and thanks for taking my questions, and three if I can, please. I understand you're keeping the 5% to 7% negative pricing impact in the U.S. Generics business. I'm just curious with the new launches and what we've seen from the results from some of the U.S. distributors, why you're not more confident to narrow that expectation. And second question is, we saw Jazz's results that Xywav is now 32% converted in eight months. So curious what your expectations are for Xyrem launch. And my final question is on the Injectables business. I guess, with the U.S. down 8% and the European business growing 40%, you're still able to deliver a 38% margin, which was, I guess, above what I was thinking, given the mix of the business. So I'm curious if the U.S. is higher margin and you're expecting more in the second half, why you're not more optimistic on margins in the U.S. Generics business in the second half to have nudged that guidance up a little bit. Thank you.

Yes. So thanks for that. So in terms of the Generic pricing, it really is what you're saying in the mid- to high single digit. The reasoning for that, remember last year, we have the exceptionally low price erosion in the Generics. I think we came out saying that the price erosion was low to mid. I think we were saying around 4% for 2020. And we expected – and the focus last year was about supply. It wasn't so much about pricing but the security of supply in the U.S. Generic business. There was a pent-up demand for tendering, and we saw that in the first half of the year that there have been a lot more tenders in this business, a lot more pricing pressure than we saw a year ago. So we see that the mid- to high single digit is where we are coming out. I don't think that really is conservative. The impact on the distributors, they are the one tendering. You also have to remember that sometimes, the economic is even when the Generic prices go down, it doesn't flow straight into their bottom line because it also has to do with the payers and things like that. So overall, I think – and I've been listening to some of our peers' call. It feels like that the market is around this mid- to high single-digit price erosion in line with what we started the year with. And about – it's nearly – it is worse than we saw a year ago but in a way expected because we had the exceptionally good pricing year in 2020. In terms of Xyrem and when we will launch that to the market, obviously, we still have the contractual for early 2023. I think Jazz themselves in their conference call highlighted that there would be a possibility of maybe a launch in 2022. We are monitoring that, of course. We will be ready to come to the market if it comes to that. This would be an authorized generics, with an access to the REMS program that Jazz has. So the infrastructure-wise, we are ready to move. But we get a monthly sales numbers from Jazz to be able to calculate when the trigger would happen if it would happen. So we are very confident on that. I can't comment on the sales trends with Jazz, but I listened to the same call as many of you did from Jazz, and I saw they indicated maybe it could come to the market in 2022. If it comes to that, we would be ready to come to the market. But I think we will understand it better in the second half of this year and maybe be able to pinpoint it better when this could happen based on the trends in the market. In terms of the profitability in the Injectable business and why we are still guiding to 37% to 38% with a back half growth in the U.S. Injectable business, I – overall, I – there is a pricing pressure in the U.S. still with a low to mid-single digit for sure. That's number one. Number two, I think you saw that the second half of last year, 2021, James, was we had a very weak – not weak, we had a much lower operating profit globally in – both driven by the U.S. but globally because we had 42% in the first half of the year, and we ended the year around, what, 38%, 39%. So the second half of the year was somewhat lower than that. We have improved that in the first half of the year. And I think with everything we see with the pricing pressure, with the new launches, with the movement of products, with the investment we are making in R&D., I think we are expecting that we would be in line with our 37% to 38%. There's no indication even if the U.S. is growing a little bit more that there isn't a blockbusters that driving that, that should drive a much better margin in the second half of the year. Yes, the margin in the U.S. is better than in MENA and Europe, but it's not to the degree that it really moves the overall operating margin of the global Injectable business, so it would move by 100 basis points or anything like that. So we feel good about the guidance. We thought the business did extremely well in the first half of the year. It was very good that we managed to show growth globally, as you mentioned. But for the second half, I'm excited about the U.S. business, but also, I think it is a good indication, 37% to 38% of the net operating profit. James Vane-Tempest: That’s great. Thank you.

Our next question is from Thibault again. Thibault, please go ahead and ask your question.

Yes, thank you. I just wanted to have your view on – I mean, maybe a little bit on the lawsuit against Amarin. It looks like the motion for dismissal was refused. I just wonder if you could give us an update on the next steps. And then as well, if you could give us your view on the GSK versus Teva lawsuit on Coreg. I mean, it looks like we had another news flow, and in the end, GSK prevailed for now. So just if you could highlight the kind of difference and similarities with this lawsuit and the lawsuit against Amarin because obviously, Amarin was quite inspired by this lawsuit, in particular, when they obviously did – when they sued you. And maybe just a second question. If you could help us around the profitability and profit contribution for Advair in terms of P&L profitability versus cash flow profitability, that will be very helpful, including the royalties payment and the balance sheet moves. Thank you very much.

Yes. So let me take the icosapent. So first of all, the magistrate court recommendation to deny our motion for dismiss is really a procedural ruling. It doesn't take – it doesn't reflect at all the merit of the case, and you can see that from the decision by the court. And – but we are appealing that decision to the district court at the moment. In terms of if this goes ahead, this would be heard in 2023, I think second half of that year. But really, it doesn't mean anything around the merit of the case. It simply means it's a procedural that the case should go ahead. So it's difficult to make any judgment or decision based on that decision of that court. In terms of GSK versus Teva, I can't comment on that. First of all, I'm not qualified to do it. And thirdly, it's difficult to link those two cases. Of course, Teva launched with a different label in the beginning. Then they retracted the label, et cetera, et cetera. So the case between GSK and Teva are completely different than the case Amarin has against us on this labeling. So I'm – I have no comments on that GSK case because really, when you read it in details, there is hardly any commonality in the background to how the products were treated and how each company treated the different labels. In terms of the cash flow, maybe Khalid, you could step in about the cash flow of Advair.

Yes, thank you, Siggi. As we highlighted when we did the acquisition of Roxane, which is Columbus, Hikma Columbus at the moment, the earn-outs and milestones were booked at the balance sheet. You can see that on Note 17 to the financials. Of course, this will – all these royalties will go straight, so there will be a difference between the cash flow and the operating or accounting profit. Of course, accounting profit will be higher than the cash flow, I would say, that we will receive from the sales of Advair. So this is all disclosed in the notes to the financials. And it has been there since we revalued these continued liability, of course, based on our sales estimates on annual – on a regular basis.

Our next question is from Rosie. Rosie, please go ahead and ask your question.

Hey, Rosie.

Rosie, we can’t hear you, if you are – if you could hear us.

Rosie, can you hear us.

I think there might be some technical difficulties. Rosie, if you want to pop your question in the Q&A as well, I can read it out for everyone. We don’t have any more questions lined up. There we go. Rosie is just typing her question. Injectables, do we assume and guide that U.S. elective surgeries are coming back?

So a good question. Overall, we expect an improvement in elective surgeries in the second half of the year. Will it get back to normal? I don't know, maybe by year-end. But we are expecting a small improvement – or not small, a steady improvement in the second half of the year of elective surgeries. And we are hoping by year-end, we are back to normal. But at this point in time, it's very difficult to difficult to get an exact understanding due to changes in pandemic, changes in hospitalization due to COVID, et cetera, et cetera. So – but you're right from the point of view, we expect improvements, but not back to normal until end of the year if it gets to that level.

Our next question is from Joe. Joe, please go ahead and ask your question.

Just two broader questions, please. I wonder if you could give us an update on your Civica relationship, how that is going. And also, you talked about biosimilars, just in terms of any progress to making that a bigger element of your business, please.

Yes. So Joe, on Civica, that relationship is growing, and it's been doing very well. We – originally, we started with 14 products contract with Civica. We have added to that. We don't give the exact number, but we have added quite a few products to that contract. And Civica also, I think, has become better at what they're doing because I think they are getting a better flow through themselves. It's still a relatively small portion of our U.S. Injectable business, but we are very pleased with the relationship, and we have been expanding the product offering between the two companies. And it's been a growing relationship from the initiations in 2019 up until today. Every month, it's a growing business for both parties. In terms of the biosimilars in the MENA region, as before, we are very pleased. It's been going well. We are still getting the approval through especially on rituximab and – sorry, on rituximab and on the biosimilars of Herceptin. Those two products we are slowly getting into the – all our markets. I think we are up to six, seven of our 18 markets for these products. So we are slowly building them into the market. Now we are looking at what would be the next wave be of biosimilars for the markets in the MENA. So we are working now starting to think about the pipeline because this was the first basket of two products, what are the next products we bring to this market. On the U.S. side, we are evaluating the opportunities. I have maintained that I wouldn't expect us to be an active player, if we come to the biosimilars in the U.S. until after 2023. We might take a product that comes off earlier, but really, that would be more of an experience to build up the team. But I think from 2024 onwards, that would be the timeframe if we are going to be active player in the biosimilars space in the U.S. So we are working on that. We are looking at the opportunities. I think there are good examples from the U.S. market, which we think are interesting and attractive. There's also other opportunities which we don't think are attractive. I think it will be a very difficult market around nine players or nine competitors on Humira as an example. So we are still keeping – we are keeping a very close eye. We are analyzing things. But at this point in time, I wouldn't expect Hikma to be active in the U.S. biosimilar space until after 2023, if we come to the market. At least that's where we are today.

We have a follow-up question from Pete Verdult. Please go ahead and ask your question.

Pete, we can’t hear you. We see you’re trying to talk.

Sorry, hang…

Yes, now I can hear you. Sorry, you went on mute again now. There we go.

Sorry, Siggi. I'm trying to multitask and failing miserably. So just to come back on U.S. Generics. I mean, in the past, you talked about the contribution margin from Advair being somewhere between 70% to 90% on the P&L. I recognize or realize, I think we all do, that there's big pay away that are taken from the balance sheet. And then on Vascepa, you used to made it clear that the initial gross margin would be dilutive. So just can you provide us an update, because it looks like Vascepa now is on track to be doing $100 million in annual revenues. Could you maybe just give us a little sort of gauge? I know you don't guide on products, but there are important components to that margin for U.S. Generics. Any update you're willing to provide today would be helpful. Thank you.

Yes. So overall, the biggest improvement in my gross margin has to do with the cost component in our manufacturing plants for the base portfolio. What I mean by that is, this was the initiative we started about three years ago when I joined the company. We started to introduce a second supplier of our API to all of our top 10 products we have at the market at that point in time to lower the cost of API and also to secure the supply, so we wouldn't be in a difficult situation. That now is delivering the goods. That really is stepping in. And I feel – and also with the conversion cost in the plant, yes, it's a bit higher now due to COVID that we can't cover overlapping shifts and we are doing a little bit more. It's more costly to manufacture due to that. But overall, I feel that is a huge contribution to our gross margin, the overall cost structure, the strength of the plant. And also we have been increasing in volume in the plant in Columbus, which means that the overhead in the plant is distributed over more volume which lower the overall cost of goods sold per product. That's number one. Number two, the revenue from new launches have been good. Zortress, clearly, a good gross margin contributor. It is an oral – it's not an oncology drug, but it's manufactured in our high-containment facility. So it's a special manufacturing, and that's maybe why we have been alone in the market. We now have a competition on that product as an example, but that has been a good contributor to the margin. And my point on icosapent in the past was it is dilutive versus the margin of new launches. I – and it has been that. But overall, clearly, with the market as it is today – and really, we haven't seen that any competition, even though that we have both Dr. Reddy's and Apotex approved. I think we are keeping steady margin on that product at the moment. The cost of goods sold there hasn't gone down because there's still a very difficult supply situation in the market, which means that the cost of goods sold is fairly high. But it hasn't – the margin hasn't declined due to competition, at least not yet. It could do that later if suddenly some of the other suppliers in the market would have unlimited supply. But the maintenance of the margin has been good because the market itself is quite stable at the moment. We don't talk about margin of generic Advair. It's a little bit more complex. Also, it has to do with device and things like that. But overall, we are excited that, that will impact the second half of the year. So just to summarize it, it more has to do with our cost of goods sold, the cost containment in the facility, our API cost. It has to do with Zortress and the new launches, which have traditionally the new launches have better gross margin. And it has to do with icosapent. Even though it's dilutive versus new launches, it had maintain the margin a little bit longer because the competition really hasn't impacted the market dynamics so much so far.

So Siggi, forgive me, just two clarifications. Is Vascepa today dilutive or accretive to the U.S. Generics margin? And then in terms of your consistent message about looking to improve the API situation, it sounds like you are improving it but very much at a measured pace. So is that the right way of thinking about it? Or has it gotten tougher or easier to secure supply? Two clarifications, please. Thank you.

Yes. So I don't give you the margin on overall, but I've said the margin on icosapent is less than of an average new launch. I haven't ever commented on if it is dilutive or improvement versus the overall margin of the business. But versus an average launch, I've always maintained it's a little bit dilutive to that. But I'm not going further than that. In terms of your second question, Pete, if you repeat that.

Just the API supply, I mean…

API supply…

Are you increasing it in line? Or is it getting a bit better or more challenging?

No. So it's basically exactly in line. So you can see on the graph that we are slowly increasing, very slowly. I would love to have it faster than this, but slowly every month, we have a little bit more supply which we are bringing to the market. In terms of big step of availability of API that we can take more market share, I wouldn't expect that before the end of this year.

Thank you.

We have one more question from Joe. Joe, please go ahead and ask your question.

Joe, you are on mute.

Apologies. That was me technically making a mistake this end. I don't have another question.

It’s all right. No worries.

[Operator Instructions] Currently, we don’t have any more questions.

All right. So I just want to thank you all. We are excited about the first half. We are excited about the full year. As always, if you have any questions, any follow-ups, the IR team is available, as always, to answer you or if you – if I can help you in any way to explain things further. Don't hesitate to contact the team. And thanks a lot for your time today. Thanks.