Good afternoon, friends. I'm very pleased to welcome you to our Q4 and end of fiscal year 2026 earnings call. I have with me our MD, Nilesh, our CFO, Ramesh, and our head of investor relations, Ravi. We look forward to sharing with you our highlights for the quarter as well as the full year, and the outlook for fiscal year 2027. This quarter marked our fifteenth consecutive quarter of year-over-year growth with highest ever sales and profitability. While the U.S. has clearly been a standout for us, most of our regions, be it the India prescription business, other developed markets, and other emerging markets, have delivered double-digit growth, growing 14% year-over-year. This highlights the strength and resilience of our business model and geographically diversified business. Fiscal year 2026 has been a stellar year for the organization, with revenues and profitability at record levels.
Turning to individual business segments, our U.S. business continued growth momentum, surpassing the record sales achieved in the last quarter. For the full year, our U.S. business achieved sales of $1.3 billion, an impressive growth of almost 40% year-over-year. Growth was driven by new products such as tolvaptan, where we benefited from being the only generic on the market, mirabegron, where we had the benefit of full year of sales, and new complex injectable products like generic Risperdal Consta with CGT exclusivity. Also, our first product from our proprietary Nanomi platform. Our base business also grew this year, supported by high volumes, higher volumes more than offsetting low single-digit price erosion and additional generic competition in a few key products like SUPREP and albutrol. We filed 11 products and launched 15 products during the calendar fiscal year.
Going ahead, we remain focused on doubling the share of complex products in our U.S. business, led by respiratory and complex injectables, augmented by our biosimilars in the next couple of years. In the next three years, we expect to launch 50-plus products in the U.S., with 10 exclusive first to files, four biosimilars, as well as two to three 505(b)(2)s. In addition, we remain committed to expand our specialty portfolio through a mix of organic initiatives and targeted acquisitions. Coming to India, our India business has grown 11.5% year-over-year in the quarter, with the core prescription business growing 14.5%, representing a 1.2x growth against IPM. All our key therapies outperformed the respective market growth, with respiratory segment and cardiac growing at 2.5x and 1.3x their category growth.
I would specifically like to mention our diabetes segment, which grew at 20.9% year-over-year, outperforming category growth by 1.4x during the quarter. For the full fiscal year, prescription growth stood at 10.6%, ahead of IPM growth of 9.9%, led by a strong volume growth of 6.4%. The chronic segment now accounts for 66% of our portfolio, up from 64% in fiscal year 2025, and we have set ourselves a target to increase this share to 70% in the next five years. During the quarter, we successfully launched our version of semaglutide injection under the brand name SemaNext, targeting diabetes and endocrinology specialists, and Livar ise, focused on GI and gynec physicians.
I'm happy to share that over the past one month, we are now ranked either two or second or third amongst all the branded generics, which is a testimony to our strength and capabilities in this segment. We are confident of further leveraging these capabilities to launch our oral tablet product later this financial year. We remain confident that our India Formulations Business will continue to perform IPM by 1.2x, 1.3x , supported by a strong sales force of nearly 12,000 people and pipeline of more than 80 new product launches over the coming years, including innovative in-house and in-licensed products. Our other developed markets, Europe, Canada, and Australia, accounted for 12% of our total sales and grew 13.3% in fiscal year 2026.
Within this, our European sales have surpassed the $ 200 million mark, having grown at a healthy double-digit during the year. We expect this contribution to increase as we roll out a pipeline of complex products, including biosimilars, and integrate our newly acquired VISUfarma business from this quarter onwards. Emerging markets delivered an impressive 49% year-over-year growth in the quarter, led by Brazil, South Africa, and Philippines. Brazil continued a strong momentum of the last three quarters, growing 113% year-over-year in local currency during Q4, driven by successful commercialization of dapagliflozin.
We are starting to establish a real presence in the diabetes and metabolic space in the emerging markets, with dapa serving as a strong start and the launch of empagliflozin in Brazil and South Africa this year, as well as semaglutide in South Africa later this year. Turning to R&D, our spend was 8% of sales this quarter and 7.5% in fiscal year 2026, with continued focus on complex and specialty platforms. We have over 50 active products in the pipeline, with near-term emphasis on respiratory, complex injectables, and biosimilars. We have also evolved a strong 505(b)(2) pipeline in the last couple of years, and we'll start seeing product launches in the next two years. We are also strengthening our India innovation portfolio through both in-house development and in-licensing of late-stage assets.
Switching to compliance, we received the EIR for Goa and BII status from the U.S. FDA during this quarter. We are on track with our remediation efforts at our Pithampur Unit 2 facility. As we have mentioned in the past, we remain fully committed to maintaining the highest standards of quality and compliance across all our sites globally. In conclusion, reflecting on the year gone by, we outperformed all our metrics, delivering strong financial and operational performance and achieved significant milestones. This strong performance was driven by record earnings in our key markets, U.S., India, and Europe, as well as significant turnaround in markets such as Brazil, proving that perseverance and disciplined execution deliver results. In parallel, we have made meaningful strides in building a robust innovation-driven pipeline across multiple platforms.
We are also advancing cross-functional initiatives that leverage state-of-the-art technologies and AI to enhance efficiency and prepare the organization to operate at its best in an increasingly competitive and challenging global environment. We have built a strong foundation which positions Lupin for sustainable growth. As mentioned in our earlier directions, we expect to grow our top line high single digits with margins at around 25% in fiscal year 2027, despite increased headwinds from an uncertain geopolitical environment. With this, I will hand it over to Ramesh for a deeper analysis of our performance.
Thank you, Vinita. Friends, I welcome you all to our Q4 FY 2026 and FY 2026 annual earnings call. I'm happy to report another quarter of strong results, with total revenue from operations growing 32% year-on-year to INR 7,475 crores and EBITDA growing at 68% year-on-year to INR 2,171 crores. This marks the 15th consecutive quarter of growth from the company. On a full year basis, the performance has been equally strong, with total revenues from operations growing 23% to INR 27,958 crores and EBITDA excluding Forex and other income growing 55% to INR 8,160 crores. EBITDA margins at 29.7% have increased 590 basis points year-on-year, led by higher gross margins and also operating efficiencies in our business.
I'm happy to report that we handsomely beat the guidance we set at the beginning of the year, both in terms of sales growth and margin trajectory. What is heartening is that the growth has been diversified and robust across our major geographies, be it the U.S., which grew 46%, India prescriptions, which grew 10.6%, other developed markets, which grew 13.3%, other emerging markets, which grew 35.2%, or on our GI Business, which grew 11.8% during the year. During the quarter, the U.S. business recorded sales of $371 million, 6% higher quarter-on-quarter in constant currency terms. This growth has been driven by new product launches and higher volumes in base business, offset by additional competition and lower seasonal product sales.
For the full year, the U.S. business has recorded sales of $1,318 million, $1.31 billion, as against $944 million last year, registering a growth of 40% year-on-year in constant currency terms. This has been led by volume growth in our base business and healthy contributions from new products, offset by single-digit price declines due to additional competition in key products like albuterol during the year. Our strategy of focusing on complex products has paid handsome dividends, which is demonstrated by the launch of key complex injectables like Risperdal Consta, glucagon, and Lila-Liraglutide this year. This will be strengthened by the launch of our first biosimilars in the U.S. in FY 2027.
We have an attractive pipeline of more than 60 products in injectables, the respiratory portfolio currently under development, which will augment our complex portfolio going ahead. The India region. During the quarter, the India business recorded sales of INR 1,908 crores, growing at 11.5% year-on-year. I would like to highlight the core prescription business grew by 14.5% year-on-year as against an IPM growth of 11.6%, translating into 1.3x times the IPM growth. This is offset by lower tender sales in our GIB business.
On a full year basis, the India business grew by 7.1% year-on-year to INR 8,114 crore, with the prescription business growing 10.6% as against IPM of 9.9%, translating to 1.1x times the IPM growth. Key segments like cardiology and respiratory handsomely outperformed this category, growing at 1.3x and 1.7x respectively. This is offset by lower growth in diabetes segment, which grew 9.4% as against category growth of 12.2%, impacted by loss of exclusivity for certain in-licensed products. Volume growth has been a healthy 6.4% during the year against IPM volume growth of 2.6%, and the chronic share in the mix has increased to 66% from around 64% in FY 2025.
The share of in-licensed products in the quarter has reduced to about 6% of our portfolio from 12% last year, while it's also having a positive impact on our profitability going ahead. We launched 15 products in FY 2026 and plan to launch about 20 products in FY 2027. We remain confident that our India Formulations business will continue to outperform IPM by 1.0x-1.3x going forward, supported by sales force of about 12,000 people and a pipeline of more than 80 new product launches over the coming years, including innovative in-house and in-licensed products. Other developed markets. For the quarter, our other developed markets, Europe, Canada, and Australia, recorded sales of INR 845 crores, growing 7.1% year-on-year and accounting for 12% of our total sales.
For the full year, these markets recorded sales of INR 3,244 crores, growing 13.3% year-on-year and contributing 11% of our total sales. We expect this contribution to increase as we roll out a pipeline of complex products and incorporate the acquisition of VISUfarma in FY 2027 first quarter. Emerging markets. For the quarter, emerging markets recorded sales of Rs. 991 crores, delivering an impressive 49% year-on-year, led by our key markets of Brazil, Mexico, South Africa, and Philippines. Brazil, in particular, maintained strong momentum post the turnaround of last few quarters, growing 113% year-on-year in local currency terms, driven by successful commercialization of dapagliflozin.
For the year, emerging markets registered sales of INR 3,483 crores, growing at 35.2% year-on-year, led by growth in Brazil and South Africa. Getting on to the P&L, other operating income. Other operating income at INR 83 crores is against INR 105 crores in Q4 FY 2025, has decreased by 21% year-on-year during the quarter. This decrease is primarily on account of lower export benefits from the PLI scheme during the quarter. On a full year basis, other operating income came in at INR 471 crores against INR 516 crores last year. Turning to the gross margins. Gross margins continue their upward trajectory during the quarter at 75%, up from 61.7% in Q4 2025 last year and up from 73.5% in Q3 FY 2026.
For the full year, gross margins have improved to 73.3% from 69.2% last year. This 410 basis points year-on-year improvement is driven by multiple factors, which includes better product mix, higher profitability in India from lower share of in-licensed products, increased volume and other cost improvements and efficiencies which we have undertaken over the last several quarters. Employee benefit expenses. For the quarter, employee benefit expenses stood at INR 1,243 crore, increasing 24.1% year-on-year from INR 1,001 crore in Q4 FY 2025, translating to 16.8% of sales, vis-à-vis 18% last year. This change is largely attributable to higher costs due to regular annual increments and business growth during the year.
For the full year, employee costs have increased 15.4% to INR 4,575 crores, mainly driven by annual salary hikes, India field force expansion, and Forex translation. This translates to 16.6% of sales in FY 2026, vis-à-vis 17.9% of sales in FY 2025. Manufacturing and other expenses. Q4 FY 2026 manufacturing other expenses came in at INR 2,209 crores, a growth of 30.9% year-over-year, which translates to approximately 29.9% of sales as compared to 30.3% of sales in Q4 this year. The expenses were higher, mainly due to higher volumes in the normal course of business and license fee payments on account of settlement agreements.
Manufacturing other expenses in FY 2026 came in at INR 7,898 crores, an increase of 19.2% year-on-year as compared to FY 2025. This translates to 28% of sales as compared to 29.8% last year. This has been led by primarily higher R&D outlay, higher SG&A on account of field force, field force expansion, license fees on settlements, one-time acquisition-related costs and higher volumes of increased sales. R&D is at INR 590 crores. That's 8% of sales in Q4 FY 2026 as compared to INR 543 crores at 9.8% of sales in Q4 FY 2025. For the full year, R&D is INR 2,063 crores, translating to 7.5% of sales. We expect R&D to be around 8% of sales for the next fiscal. EBITDA.
Ex-EBITDA, excluding Forex and other income during the quarter, was INR 2,171 crores, vis-à-vis INR 1,292 crores the same period last year, an increase of 68% year-on-year, with margin of 29.4% vis-à-vis 23.2% last year in the same period, an increase of 620 basis points over the last year. On a full year basis, EBITDA was INR 8,160 crores, a sharp increase of 54.6% year-on-year with margins of 29.7% vis-à-vis 23.8% over the same period last year and significantly higher than our margin guidance of 27%-28%. The effective tax rate stood at 22.1% for FY 2026.
For FY 2027, we expect the ETR to be about 25%-26% due to the phasing out of incentives on account of some of our domestic facilities. Turning to the balance sheet. Operating working capital stood at INR 7,132 crores. As of March 31st, 2026, which translates to 87 days of 10th working capital as compared to 110 days recorded last year. ROCE for the year translates to 28.4%. Net cash stood at INR 4,636 crores as against INR 310 crores as of March 31st, 2025. Whilst we focus on increased cash generation for our business, we would like to highlight that we continue to explore strategic allocation of our capital to ensure the long-term mission of the company, including on the specialty front.
On the ESG front, Lupin continues to make tremendous progress. Over 50% of our total energy consumption now comes from renewable sources. During the year, we achieved an important milestone with a first-time inclusion in the Dow Jones Best-in-Class Indices, reflecting a consistent focus on sustainable, responsible, and ethical business. Lupin has been included in the DJBIC burn index or Ondum as well as the emerging markets index. On the people's front, we continue to strengthen our organization capabilities through robust systems and processes. Our workplace culture has been recognized as a Great Place to Work certification across 13 countries, covering all our operations globally. With this, we'll open up floor for discussions.
Thank you very much, sir. We will now begin the question and answer session. Request all participants who wish to ask questions to raise your hands on the participants tab on the screen. We'll wait for 30 seconds for the queue to assemble. Thank you. Thank you for the patience. We'll take the first question from Tushar Manudhane.
Thanks for the opportunity, and congratulations on a great set of numbers. Just clarification.
Sorry, can you speak up? We can't hear you clearly, Tushar.
Am I audible?
Yes.
Yeah. I see. Congratulations on great set of numbers. That's first. Secondly, just a clarification on guidance for FY 2027, Madhumay highlighted high single-digit revenue growth with 25% EBITDA margin.
That's correct. We did say that, we would be looking at around between about 25%, in the vicinity of that for the full year. Of course, a high, single-digit number in terms of overall sales growth.
Effectively, are you sort of factoring the competition, for like tolvaptan kind of a product and which is why you see EBITDA margin lowering down in FY 2027?
Yes, we have factored that in, both the competition for mirabegron as well as tolvaptan.
Important. Just as far as Q4 is concerned, compared to Q3 FY 2026, while the revenue has sort of moved up on absolute basis, but EBITDA has moved down. Is it to do with the U.S. business profitability going down or ex-U.S. geographies EBITDA moving down? If you can clarify that part.
There are two parts.
Considering. Sorry.
There are two parts to that. Essentially, the margin, the EBITDA margins decline because of there's a slightly increased, you know, manpower cost, as you can see. The second is essentially we have captured what we have, you know, paid out as till as on account of mirabegron, you know, through because of the settlement as part of the manufacturing other expenses line. That's also included. There's of course, the component of foreign exchange, you know, that's been captured out there.
It's largely to do with this U.S. mirabegron related aspect, which has sort of dragged the EBITDA on a quarter-on-quarter basis, largely.
On the other expenses line.
Yeah. All right, sir. Thanks. Thanks.
Thank you so much, Tushar, for the question. We'll take the next question from Neha Manpuria.
Yeah. Taking my question. Am I audible?
Yes.
Okay. Sorry about that. Vinita, how should we think about the U.S. business in the next year, given what you mentioned about tolvaptan and mirabegron? You know, do you see any other product launches which could be meaningful? I know it's difficult to sustain this base, but, you know, even as we see competition in tolvaptan and mirabegron, you know, what sort of product launches should we look forward to over the next two years, which probably gives us confidence on the 25% margin?
Yeah. You know, with tolvaptan and mirabegron as well, apart from, you know, the additional competition, we still see, you know, the generic market growing. You know, just given the generic penetration in tolvaptan is under 40%, and then mirabegron is just reaching 50% right now. There is the potential for generic, you know, additional generic penetration and expansion of the marketplace, despite, you know, additional competition. That's one. We do expect them to be material contributors, especially in fiscal year 2027. I mean, apart from that, I think in the next fiscal year, our Ravicti product, the GPB is a material product for us in fiscal year 2027.
We have, you know, Saxenda that we hope to launch in the 2nd half of the year, which would be a material product for us. We have 20-plus products. We have two first two files as well. We have irbesartan as well as rivaroxaban that both the exclusive dosage form that we have first to file on. Another big opportunity as we you know, look at it right now for fiscal year 2027 is pegfilgrastim for us that we just entered into partnership with Valorum and expect that from Q2 and Q3 onwards will start ramping up and be a material contributor to the fiscal year.
Again about your question about the next two years. In fiscal year 2028, we see, you know, potentially the impact of both full year impact of pegfilgrastim as well as ranibizumab that we expect to launch, you know, later in fiscal year 2027. That should be a material opportunity for us in fiscal year 2028. also be in the final stages with Dulera at this point. just responding to the last query from the FDA and would expect that product to be in the market in fiscal year 2028. Plus, we have a material 505(b)(2) apixaban, a new dosage form that we filed to the agency. We expect that to come to the market in fiscal year 2028. Yeah, a good number of product launches, some exclusive first to files, you know, good impact of, you know, the biosimilars and 505(b)(2) starting.
That's very helpful, Vinita. My second question is, I think Ramesh mentioned about capital allocation. Given the increase in cash balance, which will only go up with these U.S. launches, how should we think about capital allocation priorities? I know you've mentioned this in the past, but just wanted to get a sense of what we are seeing in terms of opportunities in the market, what's interesting you, and what are the challenges in terms of not being able to deploy that money. Thank you.
I mean, we of course would like the right opportunity so we can deploy the capital effectively. Remain very focused in really allocating material, you know, portion of our capital to assets either on the specialty side of the business for the developed markets like this VISUfarma acquisition, or, you know, assets that can complement us in India, both in our existing therapy areas as well as bolster the therapy areas that we want to build. We continue to be very focused and, you know, really looking for assets in the specialty segments that we've identified.
Now that we have transacted on VISUfarma, we are seeing a high flow of ophthalmology assets, which could be pretty interesting for us, and likewise continue to look for pulmonology as well as rare neuro assets as well.
On the specialty side, the dearth of assets is not an issue, right? There are enough and more that you can look at. It's about us selecting the assets that we want.
It's really finding the right assets that from a risk standpoint meet.
Okay
internal criteria as well as give us enough in terms of potential to be meaningful to grow our specialty business.
Understood. Thank you so much. Thank you.
Thank you so much, Neha, for your question. This is a reminder to request all the participants to raise their hands from the participant tab for more questions. In the meanwhile, Binu, you can take the next question, please. Binu? Binu, are you there?
You're mute.
Yes. Hi. Hi. Yeah. Hi. Thank you. Couple of questions from my side. Vinita, given the settlement, is it fair to assume that in Q4 you have sold significantly more mirabegron compared to Q3?
Yeah. We have had, you know, some growth in mirabegron in Q4 versus Q3, just because of the growth in share, market share of other generic.
Okay. To this third player who has settled with Astellas, have they already entered the market?
No, they haven't entered the market as of yet. We believe that they're waiting for product supply.
Got it. Coming to tolvaptan, what is the timeline for competition entry that you are now looking at? I believe there is a patent expiring in September this year. Is that a relevant timeline?
Yeah. That is the timeline that we have taken into account in our plans.
Got it. One final question to Ramesh. The impact of PLI going away on other operating income, is that completely in the base now, or will we see some more decline from these levels?
No, I think, more or less. You know, there'll be some PLI coming in next year as well.
It'll come back.
Yeah.
Oh, okay. This quarterly run rate roughly is maintainable?
Yeah. Kind of.
Thank you.
Thank you so much, Binu. We'll take the next question from Damayanti Kerai. Damayanti, are you there?
Y-yeah. Yeah. Hi. Thank you for the opportunity. My first question is on VISUfarma. Earlier you mentioned this will add around EUR 50 million, EUR 60 million sales on top line and 25% margin. Just want to hear your thought on where do you look this business to grow in, say, next two to three years, and what will be the key focus segments here?
There are multiple areas, you know, where strategically the VISUfarma acquisition adds to us. Number one, geographically it expands our presence from U.K., Germany, France to Italy and Spain, markets that we had no presence in. Just leveraging the presence across the ophthalmology portfolio, taking our respiratory products, our biosimilars, NaMuscla into this market is a real opportunity for us that we see as a potential of growing our overall footprint in Europe. Second, just given the pipeline that VISUfarma has in the ophthalmology front, we expect the business to, in the ophthalmology side, continue to grow double digit in the countries that we are now present in Europe.
Third, the portfolio also has a fit in other emerging markets for certain, our team is also looking to see whether we can launch in some other developed markets. In Latin America and Southeast Asia, we have the potential of leveraging the VISUfarma portfolio into these markets. Multiple areas of synergies that our team is working upon. You know, we remain confident that this is going to be a material step in enhancing our business in Europe, as well as on the specialty front.
Sure, Vinita, and the top line should comfortably cross the EUR 100 million mark in two to three years, right? If all these factors play out well.
Yes.
Okay, that's helpful. You have the sales team and on ground support all available with this business or do you need to invest a few more as well?
No, actually it came with an excellent team on the commercial side as well as marketing and, you know, we are majority of the team we have onboarded into Lupin to be able to, you know, both build on the current ophthalmic model, but also expand Lupin's other therapy areas into these regions.
Okay, that's helpful. My second question is on your settlement for mirabegron with Astellas. You had one prepaid component, which I believe is sitting in fourth Q or four Q numbers, and on an ongoing basis you will be paying per unit cost, right? That will be part of the ongoing operating expense. If you can clarify on that.
Yeah, there are two parts to that. There is one element which of course will be captured as part of manufacturing other expenses, and the second part, which actually gets amortized over a period of time.
Okay. any indication like which will be the bigger component, whether it's part of operating expense or the one which is amortized?
Clearly, you know, it really depends on the sales at this stage. The first component is actually variable. The second is just an amortization spread over time.
We have factored in the additional cost per unit in our gross margin going forward.
Yeah.
The amortization of the EUR 75 million will be in the next two years.
That's true.
Pretty much.
Okay. My last question is regarding one product which we earlier discussed, dalbavancin. Can you update on the status of that particular product?
dalbavancin, Vinita.
Sorry?
dalbavancin. Update on dalbavancin.
Yeah, we expect to launch the dalbavancin 505(b)(2). We're expecting to launch it in fiscal year 2027.
2027 okay. Okay, that's helpful. Thank you.
Thank you so much. This is a reiteration to request all the participants to raise their hands from the participants tab for more questions, please. In the meanwhile, we'll take a 10-second break to have more hands and more taps. Thank you so much. Thank you so much for your patience. We can take the next question from Vivek Agrawal.
Thanks for the opportunity. Couple of questions on biosimilars. One is on ranibizumab. How comfortable you are with the economics of this product? If you look at the current market dynamics, right, the prescriptions have shifted to aflibercept that has a longer duration. If you look at the existing or the current incumbents, biosimilars, they have dropped this product, right, from the market. What gives you confidence that this product is going to be a material product for you? Thank you.
I mean, we actually are seeing a good amount of traction with the FDA in getting a product to market. You know, the other companies have had challenges in product supply, and we think that has been part of the reason why the product is out of the market. I think you're gonna see companies relaunching ranibizumab. We do believe that while part of the market has shifted into aflibercept, there's still an opportunity in ranibizumab. For us, we have both the pre-filled syringe as well as the vial, while majority of the competitors have vial only. We see also, you know, an opportunity for our product to be differentiated in the marketplace.
Understood. Thank you. Is it possible for you to update on pegfil on-body injector product? What is the current status, and what is the launch timelines for this product?
Yeah. We are pretty far along. We should be able to file this fiscal year. I know we have planned to launch it in fiscal year 2029, but hopefully we should be able to launch in fiscal year 2028 itself.
I didn't get it. Basically it's FY 2028 launch product.
FY 2029 launch. One of the two. Depending on FDA approval.
Understood. You talk about, let's say, around four products in the biosimilar. Which are the other two products, if it is possible for you to highlight?
pegfilgrastim and ranibizumab, the OBI, which of course is pegfilgrastim but a different dosage form, and aflibercept. The fifth one is etanercept in 2029.
Understood. Just again, one more question on biosimilars. In the next couple of years, what kind of the revenues that you estimate from the sales of biosimilars only in the U.S.?
Yeah, we haven't called out the actual revenues from biosimilars, but they're meaningful. Each product is pretty meaningful in our P&L going forward. We really look at the biosimilars opportunity as a very similar to our respiratory opportunity over the next five years.
Thank you. I have more questions. I will join back in the queue.
Thank you so much, Vivek. We'll take the next question from Saion Mukherjee.
Hi.
Saion? Yeah. You're audible. Yes.
Thanks. One question, just clarification, Ramesh, you mentioned revenue guidance, high single digit. Is it in rupee terms, and what's the currency, you know, assumptions that you have made?
You know, if there is further depreciation rupee, obviously there is a benefit that would be that we would be taking in. What I am is at a time that we actually constituted the budget, which is about three months ago.
That is rupee terms.
Yeah, it's rupee terms.
Understood. The other one is on, you know, there has been some inflationary pressure because of freight and raw material, given the Middle East crisis. What's the analyzed impact of the same that you're seeing on the P&L if the situation were to remain at the current level?
Clearly that is impacting everybody, and these are dark clouds on the horizon. When it comes to freight, for example, ocean freighting is about 15% higher, air freight is about 60% higher. There are, of course, issues in terms of raw material costs, availability of chemicals sometimes, solvent prices and all of that. We have estimated that, clearly, we are monitoring it on a very granular basis and take appropriate action in terms of possible price increases, as and when we think it is absolutely something that needs to be done.
Okay. Will you be able to quantify, Ramesh? Like, what's the impact?
I don't wanna do it at this stage.
Okay.
When we have actually, you know, reckoned the 25%, we have actually, you know, taken into account all of this as well. It's still too many moving parts at this stage.
Okay. Finally, just one question on your product filing in the U.S. I think you mentioned about onboarding products, but what about, you know, the respiratory products, Respimat, Ellipta and Enbrel, a biosimilar? What's the timeline with respect to filing for these product and, you know, when should we expect launch?
Respimat is actually in the works right now and will be a current fiscal year filing. The other, etanercept, also will be in the current fiscal year. We pretty much have the entire dossier for etanercept. There's very little work to be done to be able to file it. Material other products that we are planning to launch early for the U.S. We have, you know, eight to nine product filings in fiscal year 2027 on the respiratory front.
Ellipta, Vinita, any timeline for that?
Ellipta, we are still working on it. It's been challenging for us, but we continue to work on both the Breo and Trelegy products.
Understood. Okay, thanks. I'll join.
Yes.
Thanks, Saion. We'll take the next question from Kunal Randeria.
Hi, good afternoon. First question is on semaglutide opportunity across emerging markets. Are there any particular markets that you would like to call out that can make a meaningful contribution in the next couple of years?
I think the big market for us is India. Obviously, you know, we’ve already launched in India. I think South Africa would be the other import market. Brazil as well. Through partnerships in markets like Canada and the like as well. These three markets will probably start it off for us.
Nilesh, would you like to maybe give some color, more color on You know, India, obviously you have launched, but what about Brazil, Canada? Some timelines that, you know, you would like to share?
South Africa also this year.
This year.
Brazil also this year.
Brazil, Canada should really be filing this year.
Yeah.
Launch hopefully. Next year.
Right. The fact is that you may not be among the first wave, will it still be meaningful?
We think in the emerging markets where we have really built a market presence on the diabetes metabolic front, like I mentioned Brazil, you know, with the dapagliflozin launch and now empagliflozin launch, we're really creating a good position in the metabolic space. We see a good opportunity even as a latecomer. I think in the pure generic markets it will be tougher, but in the emerging markets it should continue to be an attractive opportunity for us.
Sure. Sure. The second question on biosimilars. I understand, you know, you'll have pegfilgrastim and maybe etanercept a few years down the line in the U.S. The entry barrier now for biosimilars is going down, the cost is going down, I'm sure a lot more players would come in. Do you maybe envisage a situation where the price erosion might be a lot steeper than what you are currently factoring in, let's say, by FY 2029, 2030?
I think, you know, unless there's a real material shift in the market model, we really see the new entrants having, you know, bringing an advantage to the overall economics in the biosimilar segment. From our perspective, the first few products that we have, obviously we've been working on these for five plus years, but as we look at the future pipeline, you know, informed by the additional, you know, the reducing hurdles from a regulatory perspective and easier go-to-market access in the U.S., also equally we're finding in Europe as well, there is a more efficient model, especially where, you know, a country like Germany are starting to tender biosimilar products as well.
We see an opportunity for products where we are in the first wave and that have limited number of competitors. Our focus from a pipeline perspective is really on products where we can be in the first wave, or, you know, limited number of competitors that can give us a unique positioning. I mean, we have a good positioning on the ophthalmology front, beyond biosimilars with VISUfarma and other products that we are planning to bring into the market. We think it really enables us, you know, as a ophthalmic player to bring in both the affordable biosimilars as well as innovative products. Beyond that, you know, the other pipeline that we are investing in for the future is a very selective pipeline that we're going after.
Got it. Just how big is the biosimilar franchise as of now?
I mean, it's a franchise in terms of.
From a revenue perspective.
Right now.
About INR 50 million right now.
Yeah.
Oh.
And that's slated to.
[About three hundred. Triple.] . Yeah
Time this financial year itself.
Yes.
Yeah. Sorry, just to clarify, largely it's from etanercept in Europe, and these would not be the end user sales, right? It would be maybe a royalty or a profit share that you might be getting.
Yeah. I mean, it's through partners primarily.
Okay. Okay. Got it. Thank you.
Thanks, Kunal. The next question is from Shashank Krishnakumar.
Thanks for taking my questions. The first one was on Spiriva. Just wanted to check if you are hearing anything incrementally in terms of competition there and whether our FY 2027 guidance sort of does that have any potential generic competing Spiriva?
We don't know for certain. I mean, we have been aware about some companies talking about the fact that they have filed products, but just given how long it takes to get these products right, we're not certain that we would see additional competition in fiscal year 2027.
Secondly, in the other expenses line item, I think certain acquisition-related costs and was that meaningful.
You know, your voice is going in and out actually.
Hello?
We can't hear you clearly.
Yeah. Is this better?
Yeah, much better. Yeah.
Okay. The acquisition-related costs which we have alluded to within other expense, was that a meaningful figure this quarter?
Acquisition costs
Acquisition costs? See, We didn't.
The expenses.
Yeah. Yeah. Acquisition cost is also included, a portion of that.
Was that a meaningful figure in full Q?
Well, it's actually part of the overall cost. There are a host of things that actually goes into, as I said, other expenses this time around. You know, we have in fact, you know, the mirabegron settlement, we've got Forex, there's of course the higher component of R&D, and there's of course the M&A expenditure also.
Got it. Just a last one on Ellipta. Just wanted to check if the challenge is that we're facing, is it with respect to the device? I think one of our peers has also recently entered into a partnership for the device. Where exactly is the challenge, if you could sort of explain what is the hurdle in terms of the filing timeline?
Yeah. It is really to achieve the product PK. I mean, we believe that we've got the right device in place. It's really the product PK, you know, getting that right and we're finding that the brand itself is fairly variable.
Okay. Thank you. All the best.
Thank you so much. We'll take the next question from Shyam Srinivasan.
Yeah. Hi, good evening. Thank you for taking my question. Just the first one on semaglutide in India. How has the launch gone? I think, Vinita, you mentioned the top two, top three. Just, what were your expectations? Maybe some of the dynamics, given a lot of investor interest, if you could just tell us how things have panned out. Now we probably don't yet have April data, for example. Just if you could tell us what's been the experience, prescription behavior, the vials versus the even the pen debate, if you could double-click there, please. Thank you.
Yeah. I think it's been a pretty solid launch. Pretty much as good as expected or even better. You know, we always expected to be a strong player, given our cardiometabolic play. You know, the product from Zydus is a unique pen, and I think that's differentiation in the market as well. Our patient support program is pretty solid as well. Good start. I think we're the number two company as a generic one, the number three product as a product itself. Good start, but very early days, right? I mean, we're talking about nine days of data. That, you know, next week we'll have data for April as well.
We've obviously had substantial increase in primary in the second month, I mean, time will show. You know, I think our goal is very clear, to be a top three player in this, as generic semaglutide, and I think we're well on track. As far as device is concerned, I think the acceptance for the pen is pretty solid, and I'm glad that we're playing there.
Yeah. Nilesh, I remember in our earlier comments you had talked about a INR 1,500 crore overall market, 50% with data. Has the volume uptake surprised you guys? Do you think there's a revision upwards in terms of sema-generic play, you think or still v ery early days?
I think with GLP once you're safe to always take it upwards. I think it's just too early to really predict long-term behavior, right? You saw how quickly Mounjaro became the biggest product in India and now I t's flattened out, right? You know, how important is a generic, how important is Mounjaro versus semaglutide? I think there are multiple things to play out. There are so many other products that are gonna come along as well. Clearly this is pretty widely accepted therapy. The number of prescribers is significant. The number of patients that have gone onto this is very material as well. Yeah, I think this is one of the biggest launches for the industry.
Got it. Thank you. Just my last question, just again back on the margin guidance, right? We're going from 29% this year to 25%, let's assume. Quarter 4 had some headwinds already, given that we had a settlement and maybe some of it played through in Q4 as well. Is there a extra sprinkling of conservativeness in our margins, or you think during the year there could be upside surprises as well?
No, this is actually as a result of, you know, we had reckoned that there could be some competition coming in for tolvaptan and possibly for mirabegron next year. That would actually in some ways impact our overall margins clearly. Of course, as you would see, our R&D expenditure is slated to increase a bit, that has also been captured in the overall guidance.
Got it. Thank you. Thank you, Ramesh. All the best.
Thank you, Shyam. We'll take the next question from Vishal Manchanda.
Hi. Good evening. On the albuterol inhaler market, wanted to check whether you expect any adverse impact on account of the GSK launch. They're supposed to launch a green inhaler around the third quarter of this financial year. Do you think the other albuterol inhalers on the market will see an adverse impact?
We don't think so. You know, we think that their product is really going to be a branded version of Ventolin. You know, that's what they have, we've been able to tell based on what we learn. We hope that it actually expands the market for albuterol. You know, we also ourself working on the green propellant MDIs. We're looking forward to see how the launch goes and, you know, we'll track it very closely.
Since you are working on a green propellant too.
That's right.
Need to launch as a brand or can you launch? You'll need to launch as a brand?
Well, so it's very early to tell, but just given, where things are, if, you know, we launch after the brand comes in, it will really be a generic green propellant product. You know, if you look at the Ventolin product, it's not had any generics so far. I think Cipla is the first approval.
Right.
That market is, has been pretty much branded, and GSK has the opportunity of converting it into the new version.
Yeah. Another one on the inhaler side. Are we planning to file Symbicort and Advair, or we don't intend to do those products?
We do have Symbicort in our pipeline. We have Advair HFA also in our pipeline.
HFA? Okay.
Yes.
Any filing timelines?
Like I mentioned, we have, like, nine products in the current fiscal year, so it's a material year for us with all the work the team has done over the last couple of years. We'll come back in the next quarter or so with, you know, the products and actual filing timelines.
Okay. Just another one on Risperdal Consta. If you could share how the product is doing and whether you intend to file other long-acting injectable products based on your know-how on Risperdal Consta?
Yeah, the product has done well so far. Actually, we've not been able to keep up with the demand. You know, we manufacture the product to the CMO and have struggled to really ramp up. I mean, you know, the brand actually has had supply issues as well, there has been an increased demand in the marketplace that we're trying to work hard to see how we can leverage our position. Also Teva has had supply issues with their supplier of the product as well, there's a real gap in the marketplace, which is a nice problem to have and we're trying to see how we can best meet the incremental demand.
As far as the platform goes, you know, while we worked first on a generic, as we looked at the potential of the platform, there are multiple innovative products where the platform can be very valuable. At this point in time, we have multiple products on for, you know, other brands in the platform and have a few conversations ongoing on potentially doing, you know, innovative product transactions with the platform.
You mean, doing your own innovative products or kind of doing that as a CDMO of partner?
We have both. We have couple of our own innovative products in the platform as well as interest from partners to work with us on co-developing, you know, long-acting versions of their products.
Can I ask you to get back in queue? There's a bunch of people waiting and maybe we should go little quicker.
Thank you.
Thank you.
Thanks, Vishal. Can we have Kunal Lakhani?
Take Vivek.
For the next question, please. Vivek, you can come in, Vivek Agarwal, for the next question. Hello, Vivek. Are you there?
Hello?
Yeah.
Yeah. Thanks for the question. Just one clarification on the products, tolvaptan and mirabegron. You talked about that mirabegron competition possibly next year, if I heard right?
That's right.
You're not expecting, let's say, in, any additional competition in FY 2027 in this product?
No, FY 2027 is next year for us.
This current fiscal.
The current fiscal year.
The current fiscal is what he meant.
Okay. Understood. Just one question on the overall U.S. business, right? We have done close to $1.3 billion of revenues this year. There are a lot of moving parts. A couple of products will come down in FY 2027. We will see some kind of additional competition, additional erosion in FY 2028 as well. It would be helpful if you just give some number, a ballpark number of U.S. revenues for FY 2027 and FY 2028 to work with. Thank you.
In the past we've said that we should be able to sustain the billion-dollar plus. At this point, we think that based on the competition that we foresee in products like mirabegron and tolvaptan, we should be able to get to a level, you know, compared to the current year where maybe it's high single-digit or low double-digit erosion in terms of revenues. That's of course a combination of the curr ent products, you know, and as well as new product launches. I mean, with, you know, our injectable launches as well as, you know, with pegfilgrastim we expect to offset, you know, some of the erosion and we expect our base business also to grow in the U.S.
Understood. So, if I heard correctly right so in FY 2028, if you are expecting that U.S. business to be a billion dollar plus, close to a billion dollar plus, right?
In FY 2027.
In FY 2027.
We expect it to be a billion dollar plus.
Understood. Thank you. That's on my side.
Thank you very much.
Last question.
I think.
Sure.
We'll take one more question.
Yes we can.
Hello, we'll take the next question from Forum Parekh. Forum, are you there?
Go ahead, Forum.
Hello.
Not audible.
No, yeah.
She's not ready.
We'll close it.
We'll close it?
Yeah.
Okay.
Thank you so much for all your questions and most importantly, patience. We'll now hand the conference over to the management for the closing comments. Thank you.
Thank you. Thank you, friends, for all your questions. Hopefully, we've been able to answer all of them. The rest, we will take them offline. As mentioned, you know, we've been very pleased with the performance our team has been able to deliver in fiscal year 2026 and continue to work hard to be able to exceed both our expectations as well as market expectations in fiscal year 2027 and beyond. Thank you again.
Thank you.
Thank you, ma'am. On behalf of Lupin Limited, that concludes this conference. Thank you for joining us and you may now exit the webinar. Thank you.