Ladies and gentlemen, it's my pleasure to welcome you all to our Post-Results TeleConference for the second quarter ended September 30th, 2025. For today's call, we have with us Dr. Sharvil Patel, Managing Director; Mr. Tushar Shroff, Chief Financial Officer; Mr. Arvind Bothra, Head of Investor Relations; and Mr. Alok Garg from the Managing Director's Office. To begin with, let me now give you a broad overview of the developments during the quarter. I'm happy to inform you that we delivered robust financial performance during the quarter, with healthy growth across our key business segments. Our U.S. formulations business delivered volume expansion and new products launched over the last 18 months. Our branded formulations business in India sustained growth momentum, outpacing the market growth for yet another quarter. The business has outperformed the market growth over the last several quarters.
In the consumer wellness space, we made our first international acquisition by acquiring the U.K.-based Comfort Click Limited. This strategic move will significantly strengthen our international presence across key markets of the U.K., EU, and the U.S.. Comfort Click Limited is among the fastest-growing digital consumer healthcare platforms in the VMS—that is, vitamins, minerals, and supplements—space and derives most of its revenues from e-commerce and D2C channels. Our international markets formulations business delivered strong growth for yet another quarter on the back of robust execution excellence across markets. With that, let me take you through the financial numbers for the quarter gone by. We registered consolidated revenues of INR 61.2 billion, up 17% on a year-on-year basis. Excluding the acquisition impact, the growth was in double digits.
Our operating profitability continued to remain strong, with an EBITDA margin of 32.9% during the quarter, which is an improvement of 500 basis points on a year-on-year basis. Consequently, EBITDA for the quarter stood at INR 20.2 billion, up 38% on a year-on-year basis. EBITDA margin for the first half stood at 32.3%. Net profit for the quarter was INR 12.6 billion, up 38% year-on-year. Now, let me take you through the operating highlights for the second quarter of FY 2026 for our key business segments. Our U.S. business registered revenues of INR 27.4 billion during the quarter, up 14% year-on-year. We filed six ANDAs, received four approvals, including one tentative approval, and launched seven new products during the quarter. On the specialty front, in October 2025, we launched Beizray, albumin-solubilized docetaxel injection, further strengthening our 505(b)(2) portfolio. We remain committed to expand our specialty portfolio going forward and address.
Diverse healthcare needs of patients. We received the first Notice of Compliance, NOC approval in Canada during the quarter, with receipt of NOC from Health Canada for Varenicline tablets, 0.5 mg and 1 mg. We have received three NOCs from Health Canada so far, including two received in October 2025. As mentioned earlier, the branded formulations business in India grew faster than the market during the quarter, with 9% year-on-year growth driven by sustained traction in innovation products and pillar brands. Chronic segment continued to grow at a faster pace, driving the overall growth of the business. In terms of therapeutic performance, the business grew faster than the market in key therapies of cardiology, gynecology, and in the super specialty area of oncology. On the super specialty front, we continue to retain a leadership position in the oncology therapy.
Contribution of the chronic portfolio has increased consistently over the last several years and stood at 44.5% as per IQVIA MAT September 2025, an improvement of 500 basis points over the last three years. During the quarter, we launched VaxiFlu, India's first trivalent influenza vaccine for global recommendations of WHO. Flu remains a significant global health concern of seasonal influenza, causing 3 million-5 million cases annually of severe illness, with 290,000-650,000 respiratory deaths annually. In the consumer wellness space, acquisition of Comfort Click marked our entry into the high-growth VMS segment. The VMS market in Europe is estimated to be around GBP 11 billion. CCL's business portfolio comprises of three brands, namely WeightWorld, which includes plant-based supplements, vitamins and minerals, collagen, omegas, probiotics, and micronutrients, and sports nutrition for adults.
Maxmedix , a specialty VMS gummy brand which caters to all pediatric nutritional requirements, and Animigo, a natural pet VMS brand which offers a range of pet care products. The acquisition will enhance the company's overseas digital business platform. It is well-positioned to benefit from rising health awareness and the growing focus on preventive healthcare. Overall, the consumer wellness business recorded revenues of INR 6.4 billion, up 31% year-on-year. Our international markets formulations business posted revenues of INR 7.5 billion, with a strong year-on-year growth of 39%. Growth was broad-based across regions, with strong demand-driven performance in both emerging markets and Europe, supported by focused execution. On the medtech front, recently, in October 2025, we acquired the remaining 14.4% stake in Amplitude Surgical after acquiring 85.6% during Q2 FY 2026 and completed 100% acquisition of the company.
Going ahead, we are looking to expand our presence in focused areas of orthopedics, nephrology, and cardiology. On the operations front, our oncology injectable manufacturing facility located at SEZ 1, Ahmedabad and Baddi Formulations Facility received the EIR report with voluntary action indicated from the USFDA against the inspections conducted in June 2025 and August 2025, respectively. This concludes the business review. I would now request Dr. Sharvil Patel to take you through the key drivers across business, our innovation programs. Thank you.
Thank you, Mr. Nayak. Good evening, ladies and gentlemen. It's a pleasure to have you all on the call today. We are pleased with our performance during the quarter and the first half of fiscal 2026. The business continued to demonstrate strong growth momentum driven by consistent performance across segments and underpinned by robust operating profitability. We are on track to achieve our targeted top-line growth and profitability for the current financial year. We remain committed to accelerating innovation that drives our long-term growth across our businesses and are guided by our strategic vision of going beyond the pill to meet diverse patient needs and deliver superior outcomes for all stakeholders. In the U.S. generics market, we consistently scaled our presence by building a diversified portfolio across multiple dosage forms through in-house development as well as partnerships.
Our growing presence in the specialty through 505(b)(2) product development initiatives and a sharpened focus on the pediatric rare disease underscores our commitment to broadening patient access and delivering differentiated therapies. With strong customer relationships and a flexible manufacturing network and agile supply chain and disciplined cost management, our U.S. business is well-positioned for sustained long-term growth. On the India front, our branded formulations business has been growing ahead of our market over the last several quarters. We are committed to building on this momentum by deepening our presence in key therapy areas through multiple growth levers. Backed by a rich and diverse innovation pipeline, we continue to deliver differentiated solutions that address unmet patient needs and expand our reach across a broader customer base. In the consumer wellness space, we aim to empower consumers to integrate wellness-driven products into their journey towards better health.
Acquisition of Comfort Click Limited marks a significant step in the wellness domain. Through this acquisition, we look forward to enhance our global capabilities, expand our footprint in digital health and personalized wellness, and pioneer scalable, sustainable models that redefine the future of well-being. The international markets formulations business, which comprises different countries of emerging markets and Europe, has emerged as another resilient pillar of growth and continues to grow in strong double digits over the last several quarters. In the emerging markets, we have adopted a focused therapy-led approach, tailoring the offerings to meet the needs of specific markets and, in turn, build a more agile, market-responsive portfolio. In Europe, the focus remains on expanding our offerings and enhancing the market coverage. In the medtech space, we have identified cardiology, nephrology, and orthopedics as the focus areas to execute our global strategy.
We shall leverage Amplitude's support for value-added innovation to meet diverse patient needs for surgeons and healthcare facilities across different geographies globally. On the cardiology front, we look forward to expanding our portfolio. In the nephrology space, we are putting up a facility for producing high-end membranes for dialysis to meet the global demands. With this, let me share some other material developments on the innovation front during the quarter. On our NC research front, we reported a positive top-line result from the pivotal EPICS phase III 2(b) trial of Saroglitazar Magnesium in patients with PBC for the U.S. market. The trial met the primary endpoint with a statistically significant treatment difference in the percentage of patients achieving a clinically meaningful biochemical response with Saroglitazar compared to placebo. We are on track to file the new drug application for Saroglitazar with the USFDA in quarter four of FY 2026.
On the vaccines front, we have received regulatory approvals to initiate phase II clinical trial for a bivalent typhoid conjugate vaccine in India. Thank you. Now we will start with the Q&A session. Over to the coordinator for the Q&A.
Thank you, sir. We will now open the call for Q&A session. We will wait for a few minutes until the queue assembles. We request participants to restrict to two questions and then return to the queue for more questions. While asking questions, request you to please identify yourself and your company. Please raise your hand from the participant tab on the screen to ask the question. The first question is from Devang.
Good evening, sir.
Good evening.
Sir, is there any... Sorry. There has been a significant increase of about 32% in other operating expenses. Could you elaborate on key drivers here? What aided these expenses?
Yeah, Tushar, can you take that?
Yeah, sure. During this particular quarter, we had acquisitions. We completed the acquisitions of Amplitude and CCL. The Amplitude was for two months and CCL for one month, which has resulted in the increase in the other operating expenses. As well as we had, because of the M&A activities, there were project-specific expenses, which also resulted in the increase in the overall operating expenses for the quarter. Those expenses were not there in the previous quarter. We expect the run rate going forward post-acquisition to be at about INR 1,500 crore-INR 1,550 crore.
Thank you, sir. My second question is, could you please elaborate on the rationale behind the proposed fundraising initiative? Is the company evaluating any large acquisition opportunity or strategic investment in either domestic or international market?
The key objective is to deleverage our balance sheet by reducing our existing debt. Also, there are strategic moves which will enhance our financial ability and agility to strengthen our capital structure, positioning us better for future growth. Also, the board has approved the enabling QIP resolution to allow us to have the flexibility to tap capital markets, which are when required. More importantly, we also have potentially, as we have always stated, opportunities to look at the U.S. specialty business and scaling it up beyond Saroglitazar. Also, opportunities in the international market, specifically Europe, and also some more innovative assets that we are looking at. This will allow us the capability to execute on some of these.
Sir, can you elaborate on the potential deal size? In what band you are looking?
We do not have currently any immediate actionable deals. As I said, the key areas are U.S. specialty, international markets, and obviously specific brands for India if any opportunity arises. Also, our existing areas that we are working on, on the med devices side.
Sir, lastly on Saroglitazar, can you please share the management perspective on the U.S. market's opportunity size? In the PBC, given Gilead's recent acquisition of Livdelzi for $4.5 billion, what is your view on the transaction in context to Saroglitazar? Commercial potential and market positioning in the same indication?
There are two approved drugs on the market today for PBC. We would be potentially the third-to market. We see this as a tremendous opportunity. The current use of medicines for PBC has seen a big uptick. We are seeing good traction for this class of drugs. We are quite excited with the potential launch that we will see in about 14-15 months from now. We see it as a large sizable opportunity and unmet need that exists. With our clinical evidence, we should be able to have a level playing field.
Thank you, sir.
Thank you. The next question is from Bino.
Hi. Good afternoon. Sir, would you like to give some idea about how Revlimid and Myrbetriq panned out? Has Revlimid come off from last quarter? What is your expectation for the next two quarters?
Revlimid for the next two quarters will not see any meaningful numbers as it was in the first quarter. It has significantly come off in terms of its sales. A substantial portion happened in quarter four of last year and quarter one of this year. We are trailing quantities in this quarter and next quarter. Quarter four onwards, obviously, there will be genericization. On Myrbetriq, we are seeing good traction and steady market share increase. We are quite pleased with the performance.
Got it. Sir, you said generic Revlimid in Q2 is significantly lower than Q1.
Yes.
Okay. Do we have yet a clear visibility about how the U.S. revenues will pan out into FY2027, given that Revlimid is not there, Myrbetriq remains unpredictable? Do we have confidence that the U.S. revenues organically can grow FY2027 or FY2026?
I think obviously it's subject to the court decision. We have to wait till February for the court decision to come. As I said, we believe that with the current pipeline of products that are supposed to come and the new launches, we will be able to maintain our current pace.
Understood. Thank you.
Thank you. We will wait for a few seconds for the question to assemble. If anybody wants to ask the question, please raise your hand from the participant tab. The next question is from Annamalai Natarajan.
Hello, sir. Good evening.
Good evening.
Hello. Good evening, sir. First of all, thank you for having a detailed discussion on this. Congratulations for giving good results. Sir, my question is on my first question is on your U.S. revenues being. Come for 45% of your consultants.
Mr. Natarajan, for some reason, I'm getting your voice is coming and breaking.
There is a 40% decrease in quarter and quarter.
I think we're not able to hear you well. Maybe I don't know if we can get a better line.
Yes, we would request to join back in the line for the same. The next question is from Neha Manpuria.
Yeah, thanks for taking my question. First, on the medtech business, in the opening comments, you mentioned wanting to expand presence in nephro, cardiology along with ortho. Could you give us some color on how we see this evolving after Amplitude? When should we start seeing? I mean, what can we do? In nephro, I think you're setting up a facility, but in cardiology, will it be another acquisition? How should we look at the entire medtech business evolving for Zydus, let's say, in a three-year perspective?
For the orthopedics, obviously, we hope to bring the portfolio of Amplitude into more geographies and continue to strengthen their position in Europe with more market access. We are very close to. Also, we have a future launch with our robot. I think that is also going to pave the way for future entry into both further market share increase in Europe, specifically France, and then also we take it to Australia, India, and other markets. Also, build our front end in India in the orthopedic space. We believe Amplitude acquisition will allow us to commercialize this and grow in double digits for the business. On the cardiovascular side, we already have a stents business that we have, and we have both drug-eluting stents and normal stents. We will also have future drug-eluting balloons, and also TAVI, which we have in-licensed.
We are going through a clinical development for Europe and also a potential launch in India for TAVI. For intervention cardiology, that is how we will continue to build on the cardiovascular side. Nephro, the facility will get commissioned in the coming year, and then we hope to start filing for the dialysis for both India and for future European markets as well.
Understood. Historically, if we were to look at, let's say, the European market, how much of a risk is pricing regulations in your assessment? Has there been instances? Because we have seen it in probably pharmaceuticals. I'm not so sure about medtech, but is that a risk that we need to sort of keep in mind? Price control or price regulations for medtech in Europe? Any color there?
No, so price, yes, every, like generics, there is price regulation. As generics are there in medical devices, there is every three to four years price negotiation. We did have a 3%-4% kind of price reduction in France, which is sort of normal as it happens every three to four years. That is some part and parcel of it. We do believe that going forward, that will be, I mean, it will be in similar lines as we move forward. We do see a lot of potential on cost reduction in Amplitude. By today, what they are outsourcing as well as how they're sourcing. We do see a benefit of Zydus bringing in significant cost reduction to improve our margins and profitability there and also gain more market share.
Understood. Based on the comment that you made in fundraising, is it fair to assume that your priority for any M&A would actually be the specialty business in the U.S. and Europe over, let's say, something in medtech? Would that be a fair assumption?
Both are important, but yes, our first priority will remain the specialty in the U.S. and Europe.
In specialty, what areas would we be focused on? I mean, which are the therapies or segments that we're looking at for acquisition? Any particular focus areas? I'm assuming part of it would be for PBC.
For us, we have, I mean. We are in, obviously, pediatric rare disease. That is one area that remains important, but we do not see any very large ticket item there. The area which we are looking at is gastroenterology as a call point. We are seeing how do we see if we can build some capability there through strategic acquisition. Also, we have Usnoflast in ALS and also recurrent pericarditis. We see some opportunity also in the CNS or in the cardiology space. I think these are some of the areas in the specialty side that we will focus on in the U.S.
I'm sorry, one last question. What would be, given specialty assets don't come cheap, what would be your, when I think about sort of target net debt to EBITDA, what is the level of leverage that you would be okay with, given the deal that side comes your way?
Currently, we do not have immediate something that we can really talk about. Obviously, we are looking at a commercial capability in the U.S. with the commercially launched product, which is either EBITDA neutral or EBITDA positive. That is what we will look to do. In terms of our net debt to EBITDA ratio, we have always said that without any equation, we do not want to cross one time. For a short period of time, we can go two times, and obviously then reduce our net debt to one time. That is the kind of range of spend that we will look at.
Understood. Thank you so much, sir.
The next question is from Kunal Dhamesha.
Hi. Thank you for the opportunity. First one on Saroglitazar in PBC. Now that you would have detailed, some details on the results, etc., if you could share how does our molecule compare with the currently marketed therapies? What are the opportunity areas that we are seeing in terms of positioning the molecule?
As I said, on Saroglitazar for PBC, we did meet our primary endpoint. I think the main results will be declared in one of the major conferences because that is how we would like to release the data in a proper conference. That will happen either most probably in the May ESL or maybe something before that, but in the coming calendar year. That is where we will put out our results. We are quite happy with the results in terms of what we have seen in versus market.
Sure. Now that the phase III trial is over, do we expect our R&D intensity to kind of go down a bit from where we were in the last three, four quarters?
Not really, because we still continue with our studies on Saroglitazar. We still continue with the new phase II B for Usnoflast. We are adding recurrent pericarditis as the next trial. No, I do not think we will see any major reduction in R&D because of this.
Sure. And beyond Saroglitazar, I think the next in the pipeline would be CUTX-101. Is that fair understanding?
CUTX-101, if we can all work. Yeah. So, that will be we are potentially looking at fourth quarter or first quarter launch next year.
Quarter four or quarter one of next year, which is calendar year or fiscal year?
Between January to June, we will see a launch. Exactly.
January to June of 2026?
Yeah. Yeah.
Okay. Okay. That would be the first one. And Saroglitazar would be potentially the second one.
Yes, you're right.
Sir, with, let's say, getting a good trial result, would you be open to leveraging these molecules for other developed markets in terms of partnership or your own venture into other developed markets? How should we think about that?
Yes. For them, for Saroglitazar specifically, we will look at other markets where we do not have direct access through partnership. Also, we already have direct market access partnerships for our rare disease portfolio. We will also build that for CUTX-101.
Sure. Sure. Do we have anything like any potential partners, etc., with whom the talks for Saroglitazar are ongoing, given that we have trial results, etc.?
I think we will. We have opportunities and options in mind, but we will wait for our publications and a filing before we initiate some of these.
Sure. And sir, one way, if I can squeeze in. On the QIP or the fundraise resolution. What are the areas? I think you suggested specialty and medtech, but do we have more of an upper cap on medtech at this point in time that these are the two, three areas that we want to invest in and then kind of execute it and see where it goes? How to think from a, let's say, next two to three-year perspective?
Our current priority will be U.S. specialty. Can you hear me?
Yeah, I can, sir.
Kunal?
Yes, I can.
Yeah. I said our current priority will be U.S. specialty and international market opportunity. Medtech, we do not have anything immediate. That is not something immediate, but obviously, we continue to be opportunistic there.
Sure. Sure. Okay. Thank you and all the best.
Thank you.
Thank you. The next question is from Damayanti Kerai.
Hi. Good afternoon. Thank you for the opportunity. I hope I'm audible.
Yes.
Okay. My first question is, can you update us on three of your focus segments, which are injectables, transdermals, and vaccine, in terms of progress in the last few years? What is the current contribution at the consult level? How do you see these segments growing in medium term?
On the transdermal side, we have obviously launched hormonal patches as well as Rivastigmine and Scopolamine as the critical patches. We have four approvals for that. We have remaining still capacity and launch for these molecules as well. One more hormone patch and one Clonidine. The business is doing well. It's a sticky business. We continue to hold good market share on that. I think that's going well. We have also filing plans for remaining one or two products. We have capacities built for that. With respect to our injectables piece, obviously, we have had not any substantial launches in the last 12 months because we had facility challenges. We have niche products launched in the U.S. through partners.
We have just launched our first 505(b)(2) in the injectable space, which is Beizray, which can potentially be quite a significant product for us in the specialty injectable side. With facilities coming out of issues, we see very important launches over the next two to three years, both from simple vials, PFS, cartridge, and pen device products, as well as products which are [DISE] related. We have a lot of products that we have in the pipeline for launch where we could have limited competition in some of them. It is still an underscaled business. We believe in the next three years, we will see it meaningfully scale up the injectable side of our business in the U.S. With respect to vaccines, as we are a strong Indian vaccines player, we have the flu and the flu, as well as rabies, as the two important.
Products that are sizable today. With the winning of the MR tender, MR also becomes a very important immunization program vaccine for us. We have TCV, which is approved by pre-qualified. We are also going to participate in TCV global tenders and potentially also MR global tenders going forward. The flu vaccine is doing extremely well. We are the first company to launch the trivalent flu vaccine now. We see significant market share for Zydus vaccine in India. That is how we are scaling up vaccines. I think, as I have said before, in two years, it will become a very meaningful part of our business. It is already tracking very well, and we are seeing good traction by winning these tenders.
Vaccine mostly remains India-focused business, right? Your international part is yet to pick up?
Today, rabies is partly our export as well. Other than that, currently, it's India-focused. I think by 2027, 2028, you will see public market access to global tenders, and we will see more foray of our vaccines in global market.
Okay. In medium term, when you say these will be sizable, that will be broadly what, 10%-15% of console number, or how should we look at in terms of contribution at top line?
Which part? You're talking about all three combined?
Yeah. Maybe injectables is something, I guess, which sounds more promising. Maybe from injectables, if you can give some thoughts.
I said injectables, we still need two years, at least two years to scale up. I would say they will be part of our overall generic strategy. We do not drive injectables as a separate strategy. Part of our portfolio forms oral solids, topicals, injectables, transdermals. That is how we are building the portfolio. It is not focused by that. It is focused by the value and product that we launch. We do have a lot of 505(b)(2) ideas on injectables, which we see traction. As you said, the Beizray product is a first launch, which we are very excited about. Potentially, you will get to see more of these opportunities in the next couple of years. With 505(b)(2), as well as 505(b)(2) injectables plus generic injectables, it will be meaningful.
Sure. That's helpful. My last question is on Comfort Click acquisition. How do you see this portfolio scaling up in, again, say, next three to five years? What will be the key growth levers here?
Comfort Click is a D2C platform for fast-growing vitamins, minerals, and supplements business. It's a very strong Europe-driven business. It is the largest market share on the online platform in Europe. This allows us to be present in the D2C digital VMS market. It also has a very strong own loyal platform business that it does, and it's also scaling up meaningfully. That also helps us in terms of building it. CCL does enjoy very strong brand recognition and high customer loyalty and retention. We believe that this product portfolio and business is strongly positioned towards the high-growth area that exists for VMS. We're quite bullish with how we can scale up, not only Europe, where they are very strong, but also launch in more markets in the Middle East, U.S., and other geographies.
They have gained significant share and lead the lion's share of the business, and we hope they can continue to build that in other markets also.
Sure. It's basically market expansion plus improving the reach within the existing.
Yes. So far, it has three assets. One is the WeightWorld, which is then the second is the animal, I mean, pet supplements, and then third is pediatric or the children gummy bear kind of range. One of them is scaled up. The other two still need to scale up. Yeah, we have plenty of opportunity. I think the key thing would be to focus and make sure we continue to build market presence stronger.
Sure. Thank you. This is very helpful. I'll get back in the queue.
Thank you.
Thank you so much. The next question is from Saion Mukherjee.
Hi. Good afternoon. Dr. Sharvil, you mentioned about the specialty business as one area where you would probably like to invest. In the current context where there are some concerns on pricing, particularly in the U.S. market, tariff is still uncertain. Does that in any way change your view around specialty? And do you consider it at high risk? How are you factoring in that risk in case you want to make a big capital commitment for that market?
From our point of view, in the space we are in, the price is already very well established by the incumbent players. It is a rare disease business. I think it has a very different connotation. We believe that currently, we do not see any major pricing challenge when it comes to the indication that we are working for. There are already precedents that exist. I do not see that as today's concern for us. Obviously, whenever we are looking at anything in the special, we are obviously looking at the importance of what pricing could be in the future. That is going to be an important factor for us to make any kind of choices.
For Saroglitazar, PBC launch, what is the kind of investment in terms of front-end you would need to make? Can you sort of, at least for the first year, as you roll out the launch, that we should model in our models?
I think we still have to go through an NDA submission. We need to then wait and see whether we get fast track or we get, if it's fast track, it's a six- to nine-month launch. If it's a normal submission, it's a one-year launch. Depending on that, obviously, we need to then decide on scaling up our presence. What we are doing is the pre-operative work right now in the U.S. for preparing for Saroglitazar commercialization. The hands, feet on the street and the real hiring will happen much later once we are more clearer towards launch. We would see that getting formulated in the next, as we present in the next financial year, we'll have much more clarity on terms of where we will be.
As I said, today, the major part is filing, and then maybe six months from then, once we have a first review with the USFDA, then talk about the ramp-up.
Can we assume like 50-100 kind of a field force that you need for this kind of a product? Or you think it could be more?
Yes. 60-80 kind of number, yeah.
Okay. Okay. One more question I have, actually, if I can, essentially, if I just see, you have made significant investments in new areas, the business has expanded in terms of new verticals as well as geographic footprint, like medtech, specialty, etc. I mean, how do you ensure that there is enough management bandwidth so that execution is proper, given this very sudden and significant expansion that we have seen?
I think that's a well for us. It is important to make sure we have the people and the process and the structure in place before we obviously do these things. When it comes to our medical device or Amplitude acquisition, we have had a leadership position as well as key people in the medical devices business in the last 12 to 15 months. That positions have already been filled. In the last 15 months, our leadership team in Amplitude will continue to work with us for the foreseeable future to build onto what they've already built. This was the team that built the business, and they're continuing. There is business continuity in terms of the leadership team that exists in Amplitude, and they're quite motivated to be there to scale this business up. I think similarly, the same I can say about Comfort Click acquisition.
The leadership team that built the business from zero to now are also committed over the next five years to take it to the next level of growth and size and scale. On the specialty front, more than two years, we have had a commercial head in space. We have a regulatory person and medical director. We already have Sentinel, which has other core capabilities on pricing and market access. I think for the majority of the businesses that we have or we are building, we already had leadership in place. All of the incumbents are ready to continue with us for the foreseeable future. I think from that point of view, I think we not only obviously had the acquisition, but we also have the key talent staying with us.
Sharvil, this talent, especially for the acquired entity like Comfort Click and Amplitude, is there a, how are you incentivizing? Is there a stock option available for the leadership team that they continue?
Yeah, there is a long-term incentive plan for all of them.
Just as a related question, like for the consumer business, do you think it makes sense at some point to list the medtech business? Because that seemed to be something very different from pharma, which is your core business.
I think once it attains certain scale and certain revenues, we will potentially look at how to further expand it. Maybe not in the near term, but yeah, that we'll see as we continue to stitch together more opportunities with [Po medt ech].
Okay. Thank you. Thank you. The next question is from Vamsee.
Hello sir. Am I audible?
Yes.
Thanks for the opportunity, sir. Most of my questions have been answered, but I just wanted to know with regards to Saroglitazarglitazole. Is there any update regarding the drug's capability to address pruritus and fatigue also?
Sorry. What was the second? Pruritus and what is the second point you said?
Fatigue, sir. Fatigue.
I think, as I said, our primary endpoint has been met. The key secondary endpoints, as well as the other benefits, obviously, we would talk about it more once we have the right publications done. I think we will be able to talk more about some of these things in the future once the data is out.
That's it, sir. Thank you and all the best.
Thank you. The next question is from Vishal Manchanda.
As I can see in the balance sheet, our intangible assets under development has doubled in the last six months from INR 1,300 crores - INR 2,600 crores . Can you share some color on what this investment is pertaining to? Are these in-licensed complex generic assets, essentially?
In this particular quarter, we have completed two major acquisitions. One acquisition is related to Amplitude Surgical, and another acquisition is related to Comfort Click. All these acquisitions, for example, Comfort Click had a couple of brands, and these couple of brands have been revalued to ensure that they are reported as intangible assets. Similarly, as a purchase price allocation for Amplitude, a couple of technical know-how and other intangible assets have been classified as intangible assets.
Actually, I meant intangible assets under development.
That is mostly to do with our licensing. Yeah.
Anything that can be commercialized in the near term?
We just commercialized Beizray, which was one of our licensing products.
Okay. On Beizray, could you talk about the clinical advantages that the drug has over the traditional docetaxel formulation?
I don't think I can offhand tell you everything, but I think there are a couple of benefits. One, it is a polysorbit-free formulation. It does help in terms of other side effects. Also, I think there are benefits in terms of stability, which exists with this formulation. I think these are the two, but beyond that, there are many incremental benefits for this, which we see in terms of better usage with the practitioners, and we are already seeing good traction with the launch.
Okay. On generic Copaxone, where you got an approval, has that been launched in the U.S.?
It will be launched very soon.
Right. And just one more on the typhoid vaccine. Any timelines on when you can bid for the tender and start supplies?
We have started already bidding for some tenders. Obviously, the major tender will still come out in the coming year, but we have bid for certain tenders. As we see any success, we will obviously appraise you all about it.
What would be the annual tender value for that?
Generally, the annual UNICEF tender volumes range between 80-100 million doses. Yeah, it's a meaningful opportunity if we get part of the tender.
Okay. Okay. Just one final one on the dialyzer project. Is this something that you are going to front-end, or you are going to be a supplier to the other dialyzer companies that sell across the world?
It's a consumable part. Obviously, a good part of it will be for supplying to partners. Then we'll later see whether we can also build further capabilities.
You'll do the final product and sell to partners?
Yes.
The final dialyzer, which is used as a consumable in dialysis?
The dialyzer, the membrane. Yeah. We will be selling the membranes.
Understood. Okay. Thank you. That's all from my side.
Thank you.
Thank you. The next question is from Nitin Agarwal.
Hi. Nitin Agarwal, are you there?
I think. We are not able to hear him. Nitin, are you there? Okay. We'll move to the next question. The next question is from Tushar Manudane.
Hi. Am I audible?
Yes, Tushar. Yes.
Sir, just with respect to Saroglitazole, is there sort of a thought in terms of tying up with a partner who would have a well-established commercial channel? Given the product has its own, definitely a great [USP]. From a commercial channel perspective, given that we have limited presence, is there a scope to tie up with someone so that the scale-up for the product can be faster?
I think as a part of our strategic imperative, we are looking at all options. Our first priority is to build our own capability. As we evaluate opportunities to license, opportunities to launch on our own, opportunities to have a larger footprint in the specialty front, we are looking at all options, and obviously, we'll take the best option which is in the long-term interest for the company. As I said, our long-term interest is still to build it ourselves. As I said, we're not giving up on other options.
Yeah, because that might take longer time, but yeah.
Yeah, we are there for the long term, so.
Just secondly on Comfort Click, this business is also spread evenly across the four quarters, per se, or we have it in our wellness segment. Concentrated in few quarters?
No, it is well spread, the Comfort Click business.
Is there an additional OpEx, which is going to be there for this business in the initial period?
No, I think the business is sufficiently manned, and it has a manufacturing footprint or other things. It is quite a light asset business that way. It has room to continue to expand without challenges.
Just lastly on Medtech side, on the similar lines in terms of additional operational cost to think about. With respect to TAVI or with respect to this metro facility coming up. How to think about, let's say, the operational cost?
On the TAVI, we will be doing a clinical trial, a Europe-based clinical trial. We will also be launching it in India. On the nephrology side, obviously, we're still building the facility, need to commission it, and then start manufacturing, and then obviously registering it. On the Amplitude side, it's already a well-established CE-approved product and business. Its robot is also close to approval and launch. The majority of the investments have happened. I think the value driver for Amplitude will be obviously growing in double digits and then saving a lot of cost.
Understood. That's helpful. That's it from my side.
Thank you.
Next question is from Saion Mukherjee.
Thanks for the follow-up. The dialyzer membrane market, I mean, what is the size of the market, and are there any local players manufacturing it, or these are all imported currently?
Currently in India, nobody is currently manufacturing and selling. We can be amongst the first one or two people who can be doing it from India point of view. We do still believe there is a good opportunity. Obviously, it'll be competitive, but we'll be able to bring scale and cost advantage.
How large is the market, sir, currently for India?
We are not targeting India. We're targeting more than India. I can ask maybe Arvind to give you the overall opportunity size, but it's not an India opportunity launch. None of our business on the med devices are India-first strategy. It is a global-first strategy.
Okay. Okay. The other question I have was product-specific. For the Semaglutide launch in India, can you confirm your visibility for being in the first wave for that?
Currently, yes, we strongly believe we will be in the first wave.
Okay. And for the Sitagliptin 505(b)(2) in the U.S., has the revenues kind of peaked out, or how should we think about that opportunity in quarters ahead?
Yeah. I think it's peaked out. We will have a steady growth till genericization. Obviously, we still have a government business that will continue till the next one to two more years.
Thank you. The next question is from Rashmi Shetty.
Yeah. Am I audible?
Yes.
Yes. Yeah. Just on the U.S. business again, excluding Revlimid and Myrbetriq. Your base business, have you seen any erosion quarter on quarter?
Our base business has been quite stable, generally. I said we have generally alluded to a single-digit price erosion, and that's what we maintain also.
Okay. Earlier, you mentioned that you'll be doing around 30 product launches, and we have done around 10 product launches in the first half. Is the guidance intact? I mean, are we on track on doing the majority of launches in the second half?
Yes. We will see 25-plus launches.
25-plus launches for this entire year?
Year. Yes.
Okay. That means that your quarterly run rate for the U.S. business will be higher compared to this quarter, that is quarter two, in quarter three and quarter four.
Oh, you will have a Revlimid drop, right?
Yeah, but Revlimid is not significant in this quarter also, right?
It is still there in this quarter. It's not not there.
Okay. Got it. Understood. Just one more question on the operating margin side. You mentioned that we would be able to maintain 26%-plus margin for this entire year. Is the guidance intact for the entire year, or are we, because in the first half, we have done around 32%?
No, our guidance is intact for the year. As I said, while U.S. business has been stable and good, I think our international business and domestic business have driven good EBITDA growths.
Okay. Despite this, Comfort Click, which has got a lower margin, right, compared to the company-level margin?
Yes, it is lower.
Despite that, you are still maintaining your 26%+ margin?
Yeah. 26% margin, excluding.
Okay. Okay. Thank you, sir. That's it from my side.
Next question is from Devang Shah. Hi, Devang. Requesting you to unmute and ask your question.
I think if we have no more questions, then we can go ahead and.
Yes, sir, we do not have any more questions. Requesting for management's closing remarks.
Thank you very much, and I wish all of you a very happy Christmas and a happy New Year. I look forward to seeing you again in the month of February for the quarter three results. Good night.
Ladies and gentlemen, that concludes today's conference. Thank you for joining us, and you may now disconnect your lines and exit the webinar. Thank you.