Hi, good evening. This is Dorwin Dias , your moderator from Chorus Call. Welcome to the GlaxoSmithKline Pharmaceuticals Limited Q4 FY 2026 and full year earnings call. From the management at GlaxoSmithKline Pharmaceuticals Limited, we have Mr. Bhushan Akshikar , Managing Director, GlaxoSmithKline Pharmaceuticals Limited, and Mr. Ronojit Biswas, Chief Financial Officer, GlaxoSmithKline Pharmaceuticals Limited. By participating in this event, you consent to the recording, distribution, and publication of this event. Kindly note that this call is meant for investors and analysts only. All participant lines will be in the listen-only mode. There will be an opportunity for you to ask questions after the presentation from the management concludes. I now hand the conference over to Mr. Bhushan Akshikar. Thank you, and over to you, sir.
Thank you very much, Dorwin. Once again, a very warm welcome to the earnings call for our Q4 performance as well as the full year. I am also incredibly happy and excited that we have our new CFO, Ronojit, joining us on this call with me. Over the last three years, we have been very objective about engaging with the investor community as soon as we have our quarter results board meeting. Here we are again, this time sharing with you some of the key highlights. But before that, just wanted to recontextualize our priorities. Over the last, as I said, two or three years, we have been clearly calling out the roadmap that we have put for ourselves. As a broadly and a very well-diversified healthcare company in India, we continue to operate at both ends of the spectrum.
At one end, in the area of prevention with both pediatric and adult vaccines, with a large GenMed business that impacts more than 270 million Indians annually, with products that impact lives at scale through our primary care portfolio. Over the last two, three years, we are building our new growth platforms on the specialty side. So that model continues to evolve. I just wanted to also restate, aligned with the global priorities, our focus remains relentless on three priorities, which is to drive top-line growth, and that is something that you will keep hearing over the next few quarters as well as we start this oncoming financial y ear.
The second priority aligned with our global strategy is also unlocking value of our innovation portfolio, especially in key markets like India, to accelerate the launch of innovative medicines and vaccines with accelerated timelines as well as reducing the launch lag that we have seen in the past. So that is something that is going to continue to be one of the mainstays. Last but not the least is continue to embed GenAI and digital ways of working so that we can continue to pull out inefficiencies and focus on improving value across the value chain. Next slide, please. A quick highlight on where the quarter was for us. If you all seen the quarter delivered almost INR 64,000 crores, INR 65,000 crores for the industry externally. These are all numbers from IQVIA, the syndicated research agency. As many of you know, we operate in select therapy areas.
The therapies where we participate, the represented market grew by about 7% for the quarter, for Q4. Within that, we did not see. We typically are mindful that this quarter is not the peak season for us given the dependence on the acute portfolio. If you see that table, we have the advanced oral antibiotics, that's the acronym for AOA. There was muted growth there. In fact, that therapy area declined by about 2% for the specific quarter. Other areas where we operate, primarily paracetamol market, grew by about 7%. Those are all the external data points in terms of how the market evolved. In context of that growth, how did we deliver our performance? We'll move to the next slide to give you a quick snapshot of how our brands delivered.
Broadly speaking, we delivered a competitive performance across our three pillars. We did see some good tailwind for the promoted brands that we have, especially brands like Augmentin, Calpol, continued to grow ahead of the market. If you see the top two, three brands that we have in our promoted portfolio, they grew at least 3 to 4 percentage points higher than the market, as evident in the EIs. Where we saw some soft demand was on brands like Eltroxin as well as the distributed portfolio. There's clearly a mixed bag on the General Medicines portfolio, which kind of diluted our growth story for the quarter.
While I'm very happy to report that vaccines continued the double-digit performance for the quarter as well, both the pediatric vaccine business as well as the adult vaccines business led by the shingles prevention vaccine, continued to deliver and continue to create newer models, operating models for us, especially in the adult space. That part of the business has continued to grow from strength to strength. For the specific quarter in isolation, was a great quarter for our adult vaccine, SHINGRIX. We've not only been able to consolidate our prescription base, but also pivot to a new cardiovascular metabolic strategy, which we've been working on for the last few months. Clearly, harnessing the bidirectional linkage between cardiovascular metabolic disease and herpes prevention. That's an area which we have been working on the last few months.
The new growth platform for us, clearly specialty business, which was almost non-existent, led primarily by the respiratory portfolio with TRELEGY ELLIPTA as well as NUCALA both have delivered performances in line with our expectations, both sustaining market share in spite of generic onslaught, especially for TRELEGY ELLIPTA. NUCALA has continued to build on the base in severe asthma patients, month after month. Every month we've been clocking more than 100, 120 patients, so that part of the business has really grown well. On the new growth platform of oncology, if you recall, two quarters ago, I shared with you the roadmap for us to really unlock value with our oncology portfolio globally. We launched two assets, ZEJULA, for ovarian cancer and JEMPERLI, endometrial cancer, so both of them have continued to grow.
The big news for us as we began Q4 was we got the approval for the RUBY-1 trial, essentially unlocking value in first-line treatment of patients with endometrial cancer. I think that's a significant win fo r us. Both these assets have continued to build a rock solid base for us as we step into the coming financial year. We've continued to develop and build on our omni-channel digital model. Apart from the 2,000+ reps that we have in the GenMed team, for face-to-face interactions, we've continued to improve our share of voice with digital ways of working, really unlocking seamless customer experience, through different touch points, including digital ways. That's continued to be one of the focal areas for us as we closed out the last financial year. The next slide.
Just one slide on a story that I've been talking about for the last couple of years. If you remember, I've been talking about the freshness index for our company in terms of what our new products will contribute. One of the stated intents that we had talked about was having at least a 10% top line contribution coming from our innovative portfolio. Happy to report that as we closed out Q4, we have almost 6% of our top line coming from the new portfolio led by innovation-led, innovation-driven medicines and vaccines, starting with JEMPERLI and ZEJULA. I just talked about these two. I just talked about what we've been able to accomplish with SHINGRIX, month after month, and last, not least, the respiratory portfolio led by TRELEGY ELLIPTA and NUCALA.
All in all, the performance on the broad-based portfolio that we have has been in line with our expectations. The growth story has been slightly muted on account of two factors. As I said, the first one was the distributed portfolio. The tail end brands did not give us the kind of tailwind that we expected, some significant headwinds there. More importantly, we continue to have the last of what we saw on the supply constraints, especially, with one of the CMOs that we had the fire. I think this was the last quarter where we had some residual impact. Those are the two principal reasons why we were not able to have the growth in line with the expectations. The underlying growth would be in the range of about 5%-6% there. That's the story for Q4.
I'll just hand over to Ronojit to give a quick snapshot of the financials before we open it up for questions. Over to you, Ron.
Thanks, Bhushan. Good evening, everyone. This is my first earnings call in this role, and I want to briefly outline how we are looking at the business both for the quarter and the full year. I will begin with the full year financials before we get onto the quarter. On a full year basis, revenues were up 2%. EBITDA grew double digit at 11%. PAT growth was also double digit at 10%. In summary, in the year, we continued our trajectory of profitable growth and margin expansion. As Bhushan already called out, our top line growth was muted because of the disruption in a key CMO, and that impacted largely our general medicines portfolio. That said, our promoted brands delivered competitive external performance, and we gained market share. The other point to emphasize is we are building momentum with our innovative portfolio and our new launches.
Both ZEJULA, JEMPERLI have delivered a great showing including the final quarter of the year. Both products with now first-line indication alongside our new respiratory portfolio, which is NUCALA and TRELEGY ELLIPTA. SHINGRIX and adult vaccine was actually a key growth driver, as Bhushan has touched on this earlier. We have delivered strong prescription growth, and we continue to build on this new data we have in cardiovascular and metabolic disease. That said, even our pediatric vaccines portfolio was up 9%, where we maintain our lead in the private vaccines market in the segments we operate. Gross margins for the year were up 190 basis points. Combined with the SG&A efficiencies we have driven, our EBITDA ratios improved sharply to 34% for the full year, which is an improvement of 290 basis points versus last year.
Our SG&A ratio is reduced by 1 percentage point, and this is in the backdrop of continued investment in our new launches and innovative therapies because this is a key driver to our future growth. The main efficiency gains were from field force productivity and AI-led optimization, which helped with our disciplined cost management. We did cross a milestone for the year. We delivered our first-ever PAT, excluding exceptionals of more than INR 1,000 crores. Earnings per share was at INR 59.60 per share. That is up 10% versus last year. We had a healthy cash generation, and our year-end cash position is now at INR 2,745 crores. Our return on capital employed was at 61%. If you have seen our announcement, the Board earlier today declared a final dividend of INR 57 per share. Next slide, please. We have consistently improved our profitability metrics, and the return ratios are stable.
As you can see, both EBITDA and gross margins show meaningful improvement over time and versus the previous year. Next slide, please. Moving to the quarter standalone. Sales were up 2%. EBITDA grew at 5% and PAT growth was at 6%. Our headline sales were muted. As we alluded to, we continue to experience some lingering impact of supply constraints, and this is also as a result of some delayed vaccine shipments, which will result in some shifting of sales into the June quarter. Notably, we continue to see great momentum on our new launches on the oncology portfolio and the new respiratory portfolio, which are now a meaningful portion of overall sales at 6%. EBITDA for the quarter improved 1 percentage point up to 35% on better gross margins and cost management.
We maintained our focus on cash generation and as we strengthen and optimize the balance sheet. Next slide, please. This slide summarizes the journey we've been on. On the left is the transition to an innovative and specialty-led business. This is important. Why? Because these are higher growth, higher quality of sales, strongly differentiated IP-protected assets, and this is where we see our future growth coming from. The second chart on the right is the constant profitability improvement which we've delivered all the way up from 24% four years ago, up to 34%, 35% in the current quarter. To highlight again, in terms of competitive performance, underpinning all of this is competitive performance on our General Medicines brands where we continue to gain share.
To sum up, in combination, the market share gains, the portfolio transformation and the profitability gains puts us in a strong position as we enter the next year. Thank you. With that, we'll move on to questions.
I'll just spend a minute because I think I skipped that slide, and thanks a lot, Ron, for that. As we segue into the next financial year, and of course, we'll open it up for questions on Q4 as well as the last financial year. I talked about the need to really build that freshness index, and I'm happy to share with all of you that we have currently 26 ongoing clinical trials, in specific areas of our interest, essentially for unmet medical needs. We have 14 studies going on. Happy to report that we just had the approval.
We got the market authorization for belantamab, which is for relapsed refractory cases of multiple myeloma, an antibody drug conjugate that we will be launching very soon. That's also a part of those 14 clinical trials. We also have a new compound, velzatinib, which is for a type of gastric cancer. The trials of that are ongoing here. Of course, another antibody drug conjugate, B7-H4, for which we've also got India to be included in the phase III-A, phase III-B trial. This part continues to be one of the biggest building blocks for us. On top of that, of course, we will continue to build our strength in the respiratory and immunology areas with the compound mentioned here. Liver disease continues to be a focal area for us.
In the next 12- 18 months, we should see more news in the areas of chronic hepatitis B, with specifically bepirovirsen and the compound that's indicated for fatty liver disease, which is now called metabolic dysfunction-associated steatohepatitis, that's efimosfermin. Those two compounds will also help us build new expertise in the area of liver disease. I think I just wanted to sum that up, because all this will play out in the coming financial year on a solid foundation of our established business of both GenMed and Ped vaccines. That's the slide that I just wanted to sum up before we open it to questions. Dorwin, we can open it up for questions.
Certainly. Thank you. We will now begin the question and answer session. You can choose to ask your questions in two ways. The first is on video. To ask a video question, please press the Ask a Video Question tab and follow the instructions to join the queue. By clicking on Join as Attendee, you will be on audio only. By clicking on Join as Panelist, you will be on audio and video. Before asking your question to the management, please introduce yourself, providing your name and your organization's name. The second way is by typing your question directly in the chat box. Please limit yourself to a maximum of two questions so we can accommodate as many questions as possible. Ladies and gentlemen, we will wait for a moment while the question queue assembles. Our first question is a text question from Jinal Sheth from Awriga Capital. Hello.
Somewhere you had given an indication that these supply issues should be out of the way, but it was a bit negative to see the impact continued. When do we expect these to rationalize, as in a way that this is lost sales? Is that correct?
Is that the end of the question, Dorwin?
Yes, that is the end of the question from Jinal.
Sure. Thank you very much, Jinal, for that question. Yes, I do own up that in the last call, we had clearly articulated that the supply issues are behind us. I think when it comes to products like Calpol, we were able to mitigate a large part of the impact that we saw in the first three quarters. As you heard from Ron, we had some residual issues on our tail-end brands, which we still couldn't address, given some of the quality issues, and that's why it's taken longer. To answer your question, I think we've taken some robust steps to ensure that from a business continuity planning, all the learnings that we've had with this incident are factored in. So that moving forward, right from the beginning of the first quarter of this financial year, we're not caught by surprise, especially with supply constraints.
That's where we are. You also heard from Ronojit that part of that supply constraint. So we shed off almost 3.5% of our top line growth even for the quarter because of the supply constraints. Part of it was phasing, because of the late arrival of some vaccine consignments. But as I said, it's a phasing issue, so it should get reflected in the Q1 of this coming financial year. So that's where we are. I must reassure you that from a board standpoint, from a management standpoint, we're putting in some robust mechanism to ensure that the business continuity planning as well as alternative contingencies are in place, especially to avoid any such issues in the future. Thanks for that question, Jinal.
Thank you. Our next question is from Ahmed Madha. Ahmed, please accept the prompt on your screen, unmute your audio and video and proceed with your question.
Yeah. Thank you so much. This is Ahmed from Unifi Capital. I have a few questions. Firstly, just to reiterate on the point you mentioned, regarding CMO supply challenges. Is it fair to assume, I had similar question last quarter, and you had mentioned 3%, 4% revenue impact and things normalizing maybe from November, but obviously Q4, we had a similar impact. So is it fair to assume from Q1 things should normalize and there shouldn't be any supply side challenges?
Mr. Ahmed, thank you very much for that question. I can only reassure you, given the visibility and the oversight that I, along with the management team have, beginning the month of April and Q1 of our new financial year, we don't have any supply constraints. As I said, including the shipments of vaccines that were delayed, for Q1 of this financial year, we are over that curve.
You also spoke about vaccines-related supply challenges. What will that be? Will it be importing from the parent entity and delays in that case? If you can expand a bit on that.
Sure. If you recall, our vaccines had to be cleared by central labs, so it was just a timing issue. Although the vaccines arrived in the month of March, we couldn't get the clearances in the right time from the regulatory agencies. We did that, in a matter of a few days, but then it had spilled over into the Q1 of the financial year. It's just a phasing issue. There are no supply constraints there. It's largely a phasing from Q4, which has got spilled over into the Q1 of this financial year, the next coming quarter.
Does that mean the primary consumption and growth and market share, all of that is intact and is, in a sense, you putting inventory in the channel is delayed. Is that way to look at it?
That's a good question, Mr. Ahmed. If you look at our offtake or the secondary sales analysis as captured even by the syndicated research agencies, our growth continues to be a healthy high single digit or double digit. That's where the underlying fundamentals and the health of the business is still intact. The phasing issues are just from one month to the other. The answer is yes.
Sure. Coming to the TRELEGY product and SATT market in general, you had spoken about fluticasone going off patent, with the loss of exclusivity and that gaining market share. How should one look at the product comparison between different, like a lot of similar sort of products coming in the same therapy? Do you see you gaining more market share moving forward? If you can explain a bit on that.
Sure. Mr. Ahmed, as you know, we are a country with almost 70 million- 80 million COPD patients. The market continues to grow, and within that growing market, with patients who continue to need treatments which will really get them relief, the single-inhalation triple therapy continues to be the fastest-growing. That's not changed. Yes, it's not fluticasone. We lost the patent on umeclidinium, which was one of the ingredients in the triple combination. You have a lot of similars or generic versions of our product, but nothing like the original TRELEGY ELLIPTA. In spite of having 8- 10 generic versions of the triple combination, I don't think we have still anyone which has a device or the quality of ease of usage as TRELEGY ELLIPTA.
In spite of having those 8- 10 generic versions being launched over the last now almost 10 months, we've not only continued to hold, but the last couple of months, including the last month of the last quarter and the first month of this quarter, we've grown our patient share and market share as well. I think in the coming quarter, I should be able to give you more color. But our continued emphasis on TRELEGY ELLIPTA remains intact.
In the vaccines business, what sort of growth rate one should think about? The prescription data you mentioned in the presentation is pretty good for SHINGRIX and you accept some supply challenges right now. If I have to look at just SHINGRIX as a product, is the sort of growth we did in FY 2026 sustainable for a couple more years considering we still have a large market to penetrate? What will be your thinking in terms of scaling up this brand?
Mr. Ahmed, as you probably know, in every investor call, I always say we don't generally give forward-looking guidance. But in terms of ensuring that we are maximizing every single opportunity, our ability to defend our market leadership position in our private self-paid pediatric market continues. That's a space where all the antigens where w e operate, be it the hexavalent category, be it the Tdap category, be it the hepatitis A or the Havrix. All the antigens where we have the pediatric space, we are distinct leaders, and I think that continues. We've grown that business in double digit for the last two successive financial years, so the intent will be to maintain that momentum. I think your question around adult vaccination, with every passing quarter, we are only improving our ability. And mind you, this is all self-paid patients.
With two years of experience behind us, now we are getting into some of the institutional accounts, getting into public accounts. I think the next 12 months, this coming financial year, especially for shingles prevention vaccine or SHINGRIX, will be pathbreaking, and that's how we see the coming year. I think in terms of giving you a blended range, it should be strong, high double-digit numbers for the vaccine business.
Sure. One more question around the specialty portfolio. You have defined it as SHINGRIX and oncology product and new respiratory products, and the number disclosed in the presentation is 6% of the sales in Q4. Will it be possible to give the same number comparable for same products in last year's Q4? As a whole, is there any sort of a sense or management thinking what percentage we need to scale this number to for the innovation portfolio?
I think, Mr. Ahmed, I'm sorry to interrupt you, but I think I answered some parts of that question even when I was presenting. Our stated intent is always to say, I've always said this, that our freshness index should be around 10%, which means can we have the innovative portfolio contributing about 10% of our top line. On like-to-like basis, that number was about 2%. You heard it in my CFO's pages. We've brought it to 6% for the last quarter, and that's the journey that we've been on. I think we'll be relentless to ensure that this growth platform really kick in for us. Watch this space. I think it's still early days. Watch for the next couple of quarters.
I have few more questions, so please allow me. I have two questions on margins.
Go ahead.
I have two questions on margins. Firstly, for the specialty portfolio, how should one think of the margin profile considering obviously these are not manufactured in India and you will have imports. So how should one differentiate the margin profile of specialty portfolio versus your base business? Secondly, just considering we have significant or rather material NLEM exposure, and there is a lot of inflation in RM prices and it is showing up in API prices and it will come to our P&L as well. So how should we navigate or how are we thinking to navigate it? Because there will be some limitations to how much price hikes you can take, there will be some RM volatility. So if you can just spell out how are you looking at margins in two different buckets.
So two things there, Mr. Ahmed. Hopefully, this is the last question.
Yeah, this is last.
Others also get a chance to ask questions. But more importantly, if you remember, we've always said that it's our stated intent to remain relentlessly focused on the top-line growth. So that's our first objective. I think anything that comes in the way of our top-line growth is secondary. The primary objective is to grow the business. In the process, we will be also focused in expanding the gross margin. So I think that's also worked out. You saw in one of the pages that Ronojit Biswas was presenting, the significant improvement that we've had, therefore leading up to the EBITDA margins that we have and our operating margins as well. But that's not the end in itself. I think wherever possible, whether it's cost optimization, whether it is locking in with agreements which will kind of protect us for the next 12, 18 months, those agreements are in place.
We are constantly looking at the evolving situation externally. And given the handle that we have on the end-to-end value chain, including raw materials, packaging materials, I think we are watching this space with every passing month. At this stage, I can't really crystal ball gaze and tell you, but I think our focus will be on to hold on to the margins that we've been able to accomplish till now. That's how I would answer you. Your second question on the NLEM. Yes, we continue to have almost 40% of our business covered in an NLEM, but I think this time around, even when an NLEM is announced, we don't have any surprise like last time. I'm sure you recall last time we had two or three of our big brands being included. Our engagement along with the industry associations are in the right direction.
I think on that front also, we anticipate that we are pretty much well ring-fenced as of now, and we have all the scenarios planned out well as of now.
Thank you. Ladies and gentlemen, we request you to please restrict yourselves to two questions only, so that we can accommodate all questioners in the queue. Our next question is from Gokul Maheshwari of Awriga Capital Advisors LLP. Bhushan, sir, in the past annual reports and interactions, you have expressed an aim to grow the business in double digits. In FY 2026, we grew 2%, in FY 2025, we grew 8%, and FY 2024, 7%. How do we bridge this gap to achieve the aspiration double-digit growth?
Thank you very much, Mr. Gokul. I think it's always good to hear from you. I think our ambition to grow double- digit remains undiluted, that's the first, and it's not only an intent, and that's the reason why I talked about the innovation portfolio. We are mindful that our established business is significantly substantial, given our operating model. As I said in the beginning, we operate at both ends of the spectrum, with a large established business. Now on top of that, bolting on all these growth platforms. If you recall, three years ago, we didn't have these kind of launches happening. I just talked about we getting the market authorization in the area of multiple myeloma for one of our key global assets called BLENREP, belantamab.
This is on top of what we already have for ovarian and endometrial cancer, respectively for ZEJULA and JEMPERLI. We've also got the subject expert committee approval. We are awaiting the market authorization for one more compound, which is a vaccine to prevent respiratory syncytial virus, which is the RSV virus. That's another one. I think between now and the next four quarters, we have at least one significant launch happening, for an unmet need, and that too, with significant value for each asset. That's how we remain pretty confident about bridging this gap. Yes, our stated intent and the actual, there was a delta and I just talked about the underlying growth being in the range of 6% even this year, if you had not had this unfortunate headwind of the CMO incident.
But that said, as I said in the beginning, the ambition of a double-digit growth remains intact. That is a roadmap that we are very clearly focused on.
The second question from Gokul Maheshwari is: What is the growth in general medicines, vaccines, and specialty in FY 2026?
Mr. Maheshwari, as it is, we generally don't give segment-wise breakup, but just to give you a broad view, we remained more or less flat for FY 2026 on GenMed, and that was largely because of losing out almost more than INR 100 crores worth of supply constraints. If you adjust that, the underlying growth would be in the range of at least 4%, 3%-4%. That is something that has been a significant headwind for us. On the vaccines portfolio, as I said, we have grown double digit. The blended growth is in excess of 11%, 12% for the vaccines portfolio. And specialty, I think on a smaller base, the growth has been significantly high. That is the blend for us, and that is why we ended up at 2%.
Obviously, moving forward, our assumption as we see the market playing out with all our supply issues behind us, and of course our flagship brands led by Augmentin, Calpol, T-Bact in place, we do estimate that the GenMed business should be back to what we have consistently delivered in the range of anywhere between 6%-8% on the top line growth. That is what we estimate. And the large part of the growth will be unlocked by the new assets plus the existing business. That is how we see the composite.
Thank you. Our next is a text question frofm Vishal Manchanda from Systematix. Hi, good evening, everyone. On your oncology assets, how long can it take for you to ramp up these to peak potential? Also, what is the size of our field force that you have deployed in oncology?
Thank you very much. Good to hear from you, Mr. Manchanda, as always. As you probably would be aware, oncology business is, because for a country of our size, we barely have 1,000 oncologists, so we don't need armies of several thousand people. In oncology, we have a team of about 25 people on the ground already for solid tumors, which is where we have ZEJULA and JEMPERLI. We've just started the recruitment for our hematology team, and that's where we will put another team to start working on BLENREP for we've just got the market authorization. That's the field force size as of now. But more than the commercial teams, I think a large part of the focus will be on the medical education and the engagement, because this is about cutting-edge science.
It's about the new readouts that happen almost on a daily, weekly basis with the trial data. That's where our energy is right now, in bringing evidence and new science to our healthcare practitioners, especially the medical oncologists and the hematologists in the coming weeks and months. To answer your first question, as you would be again aware, for oncology assets to get to peak sales, you need to have both arms unlocked. One is all those patients who are in the private setup who pay out of pocket, but more importantly, also unlock the public accounts and that both are working hand in hand. As of now, we've been very successful in unlocking value in the private setup. With every month, we have patients now who are almost on the eighth cycle.
We have some remarkable successes being shared by healthcare practitioners where patients are in complete remission, and they've had complete response rates, especially in endometrial cancer with our dostarlimab compound, which is JEMPERLI. I think we are moving from strength to strength with each month. The answer to your question, whether it takes 12 months, 24 months, I think we have put in now a new structure even to unlock our access strategy. That's where we are trying to see how we can accelerate and get to peak sales in the next 12, 18, 24 months for these assets.
Thank you. Our next text question is from Julie Mehta of 360 ONE Capital. How much revenue contribution comes from specialty and innovation portfolio on an annual basis? Secondly, it is great to see our pipeline under clinical trials expanding, and even at parent level, we are seeing several assets progressing well. Just to understand, what is the kind of market opportunity do we anticipate from BLENREP?
There were two parts of the question. First is, again, as I said, the big change we have seen in the last three years, and I have talked about it in every investor call, in every earnings call, is our ability to therefore unlock the significant value from our global pipeline. That is why, if you recall, that number was 16 global trials two quarters ago. We now have 24 global trials happening in India, and that is a significant milestone, especially when you get phase III-A, phase III-B trials happening in India. We can use the same data and use it with the regulators to help accelerate the launch. A case in point is BLENREP. I just talked about belantamab in multiple myeloma. As many of you may be following, even in Western markets like the U.S., this product was launched just a few months ago.
So you can imagine the launch lag is barely reduced to six, eight months now between the first launch that happens typically in the U.S. market and India. So that is going to be the focus for us. How do you really build the regulatory agility to keep this building block of accelerated launches as the central theme of everything we do moving forward? I will answer your next question. Multiple myeloma is a significant area. It is the third most reported blood cancer reported, hematological malignancy reported even globally. So if you see the number of cases that are reported globally, very significant, huge numbers. Coming to India specifically, if you look at multiple myeloma, we have about 18,000 new cases that are reported in India annually. So that is the incidence.
The prevalence is in the area of 40,000, which means there are always at any given point of time, at least 40,000 patients who have multiple myeloma. The reason I am mentioning those two numbers is, as you may be aware, multiple myeloma is essentially a refractory disease, which means, any patient who gets response in the first line will still need, because there is a relapse, he or she will still need a second line. I think the good news for us and patients who need this innovative treatment is the approval that we have got is for second line. So the advantage of using belantamab in early lines, and therefore having significant overall survival, progression-free survival will be the key aspect for us.
I think in terms of sizing the opportunity, I will not put it in values, but I think our objective will be to have as many patients of these 17,000 or the prevalence of 40,000 that are available at any given point of time to benefit from BLENREP in early lines, especially in second- line, as we keep hearing from healthcare practitioners. So that will be the focus for us. I think watch this space as we launch it and share the outcomes and the progress.
Thank you. Our next question is a text question from Udhayaprakash from Value Research. Can you expand a bit more on the supply issues? What actually started it? Because if we look at the growth over the past three years, except for two, three quarters, we have had multiple quarters with single-digit revenue growth. Of course, we had a healthy expansion in margins, which supported profits, but is this the level of growth we can expect going forward, too?
Thanks again for that question. I think I answered this question in part in one of the earlier questions. As I said, the stated objective, not just the intent, continues to be a double-digit growth. So I think that is something that is undiluted in terms of the roadmap that we have set for ourselves. Yes, we were dealt with an unfortunate incident at one of our most significant CMOs with a fire that started exactly a year ago, in April. I mean, that event happened in April. But the follow-through in terms of remediation, getting the site revalidated, ensuring that every single pill that comes out of that site has the same standards that GSK expects so that no single patient is exposed to any risks and safety issues, that took longer than expected. And that is really the story for us.
As I said, it is unfortunate, but it has also made us work harder to look at business continuity plans in place and look at alternatives as well, so that we move forward in the coming term. So I think that is where we were. A large part of the portfolio that got impacted was led by Calpol in the first six months. We got the products out by the end of Q3 for products like Calpol, but there were still some tail end brands, some brands which were distributed which still are material for us in terms of losing out those 28, 30 crores that we did for Q4. So I think beginning the first quarter of this financial year, that supply chain is now remediated, and we do not have any more supply constraints from that side. So that is the long story to give you a quick summary of what happened there.
Thank you. Our next text question is from Vishal Manchanda from Systematix. Any broad guidance on how operating margins would work out for your oncology portfolio versus the rest of the business? Also, to get a sense on affordability of your oncology portfolio, can you give a range as to how it is priced on a per-patient, per-year perspective? Can you also guide whether these treatments get covered under health insurance plans?
Mr. Manchanda, thanks for all the questions again. Yes, as you probably are aware, I will take the pricing question first. We have always had an India-centered, India-focused tiered pricing model. So obviously, if you look at the cost of treatment for products that we have both in ovarian cancer and endometrial cancer, namely ZEJULA and JEMPERLI, we do have patient assistance programs in place. So I would say the cost of treatment is still in line with the class of treatments. Remember, JEMPERLI is an immunotherapy. It is among the leading immunotherapies globally in terms of the kind of indication that we are pursuing. So given the kind of evidence, given the overall benefit that we are seeing both for progression-free survival and overall survival, the cost of treatment is pretty much in line with what you would see with the standard of care right now in the market.
I wouldn't hazard a guess in terms of the exact prices, because every patient needs a unique dosage regimen. So anywhere between INR 10 lakhs- INR 16 lakhs is what patient end up paying in some of these types of cancer. But again, as I said, it is a function of the dose required, it is a function of how many cycles are required. But to especially overcome that challenge, we have already instituted specific patient assistance programs under the Project Phoenix for patients who need that benefit. Your second part of the question, what will it take to unlock? I think I answered that. Our objective is also to unlock value in the public accounts. We are working very closely to get on the GT exemption list so that we can start participating, especially for the proprietary innovative medicines to get on some of these formularies.
That is an equal emphasis that we are placing. Probably in the next six to eight months, we should have more progress on the public account. But as of now, we are moving from strength to strength every month within the private setup, private segments. Your question around the insurance schemes, I think again, every insurance policy, every insurance scheme has its nuances. Not all insurance policies cover cancer coverage, especially for medicines, although hospitalization is covered. But there are certain policies which do cover, and that is where we are just about scratching the surface as of now. So there is no real impact that we have seen in terms of unlocking the insurance segment. I hope I answered your questions, Mr. Manchanda.
Thank you. Ladies and gentlemen, if you wish to ask questions, you may click on the Ask a Question tab. Alternatively, you may enter your question into the chat box below. Our next text question is from Rajat Srivastava from Tata Asset Management Company. With top line expected to grow in double digits, do you expect margins to see further expansion, or would you be reinvesting back for growth?
Mr. Rajat, as I said in the beginning, our objective is always to grow the top line. In the process, if we are able to get a favorable tailwind on the EBITDA, it's an outcome that not we work as a primary endpoint. Our objective will be to maintain the margins and not to We would love to reinvest in the business. As I said, the amount of launches that we're having in the next six months for this locally listed entity are significant. We have at least two significant launches in the area of oncology, one in the area of adult vaccine, and that would all require investment. We would rather invest that money in growing the business with the expectation that we are able to hold the margin. So that's my response. I don't know, Ron, if you want to add something there.
No, I think you summed it up very well.
Thank you. Our next question is from Vishal Manchanda. Vishal, you may accept the prompt on your screen to unmute your audio, video, and go ahead with your question.
Yeah. Hi. Thanks for the opportunity again. On bepirovirsen, which is the hepatitis product, when do you expect an approval there?
We are still working very closely with the subject expert committee. The trial was completed, the first readout. If you saw the global readout, we are expecting the launch in several key markets, including Japan. We have just signed a deal in China for a partnership to unlock, given the huge prevalence that you see of chronic hepatitis B. Given the fact that it is the first potential functional cure for chronic hepatitis B, we do estimate there is a huge amount of work that we will have to do along with Regulatory agencies, more importantly, the health ministry, both at the state level as well as the national level. We want to ensure that we have got everything right. To your question, we estimate the market authorization to be with us probably in the next six months. I estimate it will happen this financial year.
Okay. And in the trials, how many patients got completely cured on account of the drug?
If you have seen the comparator, Mr. Manchanda, there is no functional cure for chronic hepatitis B. If you see the trial readouts, for the first time you have, I think, 25% of the patients getting complete functional cure. I think that from a baseline of almost nothing existing, you have something which is for the first time actually talking of a potential functional cure. That itself is a significant step change. That is where the first readout is.
Right. Okay. Any sense on what is the current market size like, how many patients would be on a treatment for hepatitis B and some sense on the pricing strategy so that we can understand the potential opportunity here?
Yeah. Mr. Manchanda, at this stage, probably I won't hazard a guess in terms of pricing because as I said, we are still launching this asset in some of the key markets. This requires a well-orchestrated effort, especially in some of the big markets like ours, where there's a huge unmet need, but at the right price point. I think we want to get this right. Watch this space. We'll definitely answer this transparently with you. But at this stage, it's still work in progress.
On oncology, you've been talking about opening up public accounts. Is that government patients or government hospitals that you're talking about when you say public accounts?
If you see the specialty model, especially in oncology, what is known as CARE accounts as a term across the industry, which is CARE is an acronym for CGHS, Army, Railways, and ESIC patients.
Okay.
Those are the ones where you primarily start getting into ensuring that beneficiaries in all these institutions get access to your proprietary innovative medicine. Those are the accounts that we are working on in terms of inclusion.
Okay. You have similar realizations across private markets and these public accounts.
Absolutely, yes.
Okay. On the patient assistance program, is that funded from the GSK P&L or the parent P&L, the patient assistance program?
It is all a blended. See, the way we work is obviously we look at the P&L per business unit, and I think it is all, we ensure that the margins remain undiluted for our locally listed entity.
Okay. Right. And this patient assistance program is usually higher when the product is launched, and you kind of lower this as the product matures. Is that right to understand?
No, Mr. Manchanda. I think clearly every patient, regardless of where you are in your life cycle need, because disease doesn't differentiate whether you are a just-launched product or in the market for five years. The assistance programs don't differentiate. I don't think that is the criterion. I think it is about what is the unlock that we can have, especially given the huge cost that patients have to bear in our country. The answer would be no. Regardless of what stage in your life cycle you are, they would be consistent.
Thank you. Our next question is a text question from Udhayaprakash from Value Research. Would it be possible for you to give an overview on the margin expansion that has occurred over the last four years? Our top line growth has been in single digits, and a good chunk of the portfolio is in NLEM. Exactly what happened and what drove these margins?
If you've seen the last four years, before I hand it over to Ron to give his flavor. Three and a half years ago, when I started doing these industry meetings, my first industry meeting, I remember we were just included. A large part of our portfolio was included in the NLEM that was announced end of 2022, around October, November 2022. And at that time, in that first industry meeting, I had clearly articulated along with the then CFO our ability as well as our clear intention to grow volumes, and that's been the real underlying story for us. If you see each of the assets that was included, we've grown volumes at least 2x over these four years, and that's been the story for us. There's been a relentless focus on pulling out inefficiencies. We've been working on cost optimization.
We've also looked at unlocking digital ways, embedding IA and AI both. As I keep saying, it's not just artificial intelligence, but also seeing which are the areas where we can have intelligent automation or IA to help our frontline sales reps really help unlock and create that seamless experience for our healthcare practitioners. I think it's a mix of these three, but I think I would also request Ron to add too.
Sure. Happy to contribute. The way I see it, there are three levers we've used, and I'll speak more to the gross margin, and then I'll add on. One is we've consciously focused on shifting our mix away from the price controls to the other part of the portfolio. So that's mix. Secondly, we've been quite competitive in terms of our pricing and our ability to keep in step with clear group pricing on portions of the portfolio.
So pricing has helped, and we are m aintaining the same price lens growth as the industry. And then the third is we've actively worked very hard at reducing the cost of goods for some of our NLEM products through active sourcing changes, forward contracts, et cetera. So that encompasses, we have helped our gross margins, plus of course the SG&A efficiencies driven by field force productivity, AI-led initiatives, has also compressed our SG&A. So you're right. All in all, that adds up to a nearly 10 percentage point, EBITDA improvement that you saw on the slides that we presented over the last four years.
Thank you. Our next question is a message from Mehul Savla from RippleWave Equity. No question, but would like to congratulate the GSK team for great focus, effort, and excellent communication regarding business and strategy. Best wishes.
Thank you very much, Mr. Mehul. Thank you. Truly appreciate it.
Ladies and gentlemen, if you wish to ask a question, please click on the Ask a Question tab, or you may enter your text question in the chat box. We have time for one last question.
[Break]
We have a question from Vishal Manchanda. Vishal, you may accept the prompt on your screen, unmute your audio and video and proceed.
Yeah. Hi. On the multiple myeloma drug where you got approvals, does that compete with Darzalex? If you have the market opportunity size for Darzalex, how large is that?
Mr. Manchanda, thanks a lot for that question. Yes, we do operate in the same market, but I wouldn't comment on a competitive brand. BLENREP or belantamab is the first antibody drug conjugate that has been approved for relapsed refractory multiple myeloma. I think the advantage, as I said, is in terms of the approval. Given the nature of the refractory cases that we see, which is the nature of multiple myeloma as a disease, early approval and early usage in early lines is really the focus for us. As I said in the beginning, at any given point of time, you have 40,000, 45,000 patients of multiple myeloma in India. Every year, you are adding about 17,000 to 18,000 new patients. You can imagine, there is a clear first-line treatment protocol that's used across by hematologists.
Typically, all patients will still relapse on that and will need a second line, and that's where you have the role of BLENREP or belantamab coming in. Given the fact that we have data that clearly shows overall survival as well as progression-free survival leading to several months of survival benefit. So that's something that is unique to belantamab, and that's what we will focus on. In terms of, as I said, values are an outcome. I think our ability to get as many patients with the benefit of having this treatment in early lines and second- line will be the focus for us.
Got it, sir. Thank you very much.
Thank you.
Thank you. We have no further questions, ladies and gentlemen. On behalf of GlaxoSmithKline Pharmaceuticals Limited, we conclude this conference. Thank you all for joining us. You may now disconnect.
Thank you very much to all of you.
Thank you very much.