Note: This is a preliminary transcript and may contain inaccuracies. It will be updated with a final, fully-reviewed version soon.
Lupin Ltd (NSE: LUPIN) Q4 2026 Earnings Call dated May. 08, 2026
Corporate Participants:
Vinita Gupta — Chief Executive Officer
Ramesh Swaminathan — Executive Director, Global Chief Financial Officer and Head of API Plus
Nilesh Gupta — Managing Director
Analysts:
Damayanti Kerai — Analyst
Kunal Randeria — Analyst
Tushar Manudhane — Analyst
Saion Mukherjee — Analyst
Neha Manpuria — Analyst
Unidentified Participant
Unidentified Participant
Unidentified Participant
Vivek Agrawal — Analyst
Shashank Krishnakumar — Analyst
Shyam Srinivasan — Analyst
Unidentified Participant
Presentation:
Operator
Hello, Good evening and welcome to Lupin Limited Q4FY26 earnings conference call. Thank you for your participation in the call today. Please note that all participants line will be in listen only mode and there will be an opportunity for you to ask questions after the opening remarks. Please note that this conference is being recorded. I now hand over the conference to the management. Thank you. And over to you.
Vinita Gupta — Chief Executive Officer
Thank you. Good afternoon friends. I’m very pleased to welcome you to our Q4 and end of fiscal year 26 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 27. This quarter marked our 15th consecutive quarter of year over year growth with highest ever sales and profitability. While the US 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 26 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 US business achieved sales of $1.3 billion and impressive growth of almost 40% year over year. Growth was driven by new products such as Tolvaptin 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 Ristodil construct with CGT Exclusivity, also our first product from our proprietary Nanomi platform.
Our base business also grew this year supported by higher volumes more than offsetting low single digit price erosion and additional generic competition in a few key products like Suprep and albuterol. 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 US 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 US with 10 exclusive first to files, four biosimilars as well as 23505 B2S.
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 cold prescription business growing 14.5%, representing a 1.2 times growth against IBM. All our key therapies outperformed the respective market growth, with respiratory segment and cardiac growing at 2.5 times and 1.3 times their category growth. I would specifically like to mention our diabetes segment which grew at 20.9% year over year, outperforming category growth by 1.4 times during the quarter.
For the full fiscal year, prescription growth stood at 10.6% ahead of IPM growth of 9.9%,
Damayanti Kerai — Analyst
Led by
Vinita Gupta — Chief Executive Officer
A strong volume growth of 6.4%. The chronic segment now accounts for 66% of our portfolio, up from 64% in fiscal year 25 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 liverize focused on GI and gynag physicians. I’m happy to share that over the past one month we are now ranked either 2 or 2nd or 3rd 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 1.2 1.3 times, 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 26.
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 busy pharma 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 Dapak leaf flows in, 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 and D, our spend was 8% of sales this quarter and 7.5% in fiscal year 26 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 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 BAI status from the US FDA during this quarter. We are on track with our remediation efforts at a Pithampur unit 2 facility. As we have mentioned in the past, we remain fully committed to maintaining the highest standards of quality 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 us, 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 that positions lupin for sustainable growth. As mentioned in our earlier interactions, we expect to grow our top line high single digits with margins at around 25% in fiscal year 27 despite increased headwinds from an uncertain geopolitical environment. With this, I will hand it over to Ramesh for a deeper analysis of our performance.
Ramesh Swaminathan — Executive Director, Global Chief Financial Officer and Head of API Plus
Thank you Vinita Friends, I welcome you all to our Q4, FY26 and FY26 annual earnings call. I’m happy to report another quarter of strong results with total revenue from operations growing 32% year on year to Rs 7475 crores and EBITDA growing at 68% year on year to rupees 21.71crores. This marks the 15th consecutive quarter of growth from the company on a full year basis. The performance has been equally strong, the total revenues from operations growing 23% to Rs 27,958 crores in EBITDA excluding forex and other income growing 55% to 8160 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 US 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 GIB business which grew 11.8% during the year.
During the quarter the US 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 US business has recorded sales of 1,318 million 1.31 billion as against US dollars 944 million last year. They’re seeing 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 Albatrol.
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 Liraglutide this year. This will be strengthened by the launch of our first biosimilars in the US in FY27. We have an attractive pipeline of more than 60 products and injectables, the Respiratory portfolio currently under development which will augment our complex portfolio going ahead the India region During the quarter the India business record sales of 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 8114 crores with the prescription business growing 10.6% and 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 FY25. 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 FY26 and plan to launch about 20 products in FY27.
We remain confident that our India Formulations business will continue to outperform IPM by 1 point to 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 Other Developed markets Europe, Canada and Australia recorded sales of 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 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 incorporate the acquisition of visu farm in FY27. First quarter
Kunal Randeria — Analyst
Emerging markets
Ramesh Swaminathan — Executive Director, Global Chief Financial Officer and Head of API Plus
For the quarter Emerging markets recorded sales of 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 posted turnaround of last few quarters growing 113% year on year in local currency terms driven by successful commercialization of Dapaji flows in
Nilesh Gupta — Managing Director
For the year Emerging
Ramesh Swaminathan — Executive Director, Global Chief Financial Officer and Head of API Plus
Markets registered sales of 3483 crores growing at 35.2% year on year led by growth in Brazil and South Africa. Getting on to the PNL Other Operating Income Other operating income at rupees 83 crores is against 105 crores in Q4. FY25 has decreased by 21% year on year during the quarter. This decrease is primarily an account of lower export benefits from the PLI scheme During the quarter on a full year basis, other operating income came in at 471 crores against 516 crores last year. Turning to the gross margins, gross margins continued their upward trajectory during the quarter at 75% up from 61.7% in Q4.25 last year and up from 73.5% in Q3 FY26.
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 1,243 crores and increasing 24.1% year on year from 1,001 crores in Q4 FY25 translating to 16.8% of sales.
Visa was 18% last year. This change is largely attributable to higher cost due to regular annual increments and business growth during the year. For the full year employee costs have increased 15.4% to 4575 crores mainly driven by annual salary hikes. India Field Force Expansion and Forex Translation this translates to 16.6% of sales in FY26. We service 17.9% of sales in FY25 manufacturing and other expenses Q4 FY26 manufacturing other expenses came in at 2,209 crores, a growth of 30.9% year on 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 part of these on account of settlement agreements. Manufacturing other expenses in FY26 came in at 7,898 crores, increase of 19.2% year on year as compared to FY25. This translates to 28% of sales as compared to 29.8% last year. This has been led by primarily higher R and D outlay, higher SG and D on account of field phone expansion, rise in fees on settlements, one time acquisition related costs and higher volumes of increased sales.
R and D is at 590 crores. That’s 8% of sales in Q4FY26 as compared to 543 crores at 9.8% of sales in Q4FY25 for the full year. R&D is 2063 crores translating to 7.5% of sales. We expect R and D to be around 8% of sales for the next fiscal EBITDA. EBITDA excluding forex and other income during the quarter was 2171crores. Visa was 1292crores the same period last year an increase of 68% year on year with margin of 29.4%. Visa was 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 8160 crores, a sharp increase of 54.6% year on year with margins of 29.7%. Visa was 23.8% over the same period last year and significantly higher than a margin guidance of 27% to 28%. The effective tax rate stood at 22.1% for FY26. For FY27 we expect the ETR to be about 25. 26% due to the phasing out of incentives on account of our domestic on some of our domestic facilities. Turning to the balance sheet, operating booking Capital stood at 7132 crores as of 31.12.2631 March 26th 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 4636 crores as against 310 crores as of 31.03.2025. 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 our consistent focus on sustainable, responsible and ethical business. Lupin has been included in the DJ BIC Bern Index and 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 our floor for Discussions.
Questions and Answers:
Operator
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 Manudani.
Tushar Manudhane
Thanks for the opportunity and congratulations on great setup. Sorry, can you speak
Saion Mukherjee
Up? We can’t hear you clearly. Tushar,
Tushar Manudhane
Am I audible?
Saion Mukherjee
Yes.
Tushar Manudhane
I see. Congratulations on great set of numbers. That’s first. Secondly, just a clarification on guidance for FY27 highlighted single high single digit revenue growth with 25% EBITDA margin.
Ramesh Swaminathan
That’s correct. We did say that we would be looking at around between about 25%, about 25% the vicinity of that for the full year and of course high single digit number in terms of overall sales growth.
Tushar Manudhane
Effectively are you sort of factoring the competition for like kind of a product and which is why you see EBITDA margin lowering down in FY27?
Vinita Gupta
Yes, we have factored that in both competition for Mirabeground as well as ton
Tushar Manudhane
And just as far as Q4 is concerned compared to Q3 FY26 while the revenue has sort of moved up on absolute basis, but EBITDA has moved down. Is it to do with the US business profitability going down or ex US geography in the moving down? If you can clarify that point.
Ramesh Swaminathan
There are two parts.
Tushar Manudhane
Sorry,
Ramesh Swaminathan
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 still as on account of Mera background because of the settlement as part of the manufacturing other expenses line that’s also included. And there’s of course the component of foreign exchange, you know, that’s been captured out there.
Tushar Manudhane
So it’s, it’s largely to do with this US mirror background related aspect which has sort of dragged the EBITDA on a quarter on quarter basis largely and other
Ramesh Swaminathan
Expenses line.
Tushar Manudhane
Yeah, all right, sir, thanks. Thanks.
Operator
Thank you so much, Dushad, for the question. We’ll take the next question from Neha Manpuria.
Neha Manpuria
Yeah, thanks for taking my question. Am I audible?
Unidentified Participant
Yes.
Neha Manpuria
Okay. Sorry about that. Vinita, how should we think about the US business in the next year given what you mentioned about the left in and Mira background? 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 Talbotin and Mira background, what sort of product launches should we look forward to over the next two years? Which probably gives us confidence on the 25% margin.
Vinita Gupta
Yeah. So with Tolvaptin and Mirabegron as well, apart from the additional competition, we still see the genetic market growing given the genetic penetration into laptin is under 40% and Medabegron is just reaching 50% right now. So there is the potential for genetic, you know, additional genetic penetration and expansion of the marketplace despite, you know, additional competition. So that’s one. So we do expect them to be material contributors, especially in fiscal year 27. I mean apart from that, I think in the next fiscal year.
Our Revicti product, the GPB is a material product for us in fiscal year 27. We have Saxenda that we hope to launch in the second half of the year which would be a material product for us. So we have 20 plus products. We have two first two files as well. We have SV Sartin as well as Rivaroxaban that both the exclusive dosage form that we have forced to file on. And then another big opportunity as we look at it right now for fiscal year 27 is Peckville Grastom for us that we just entered into partnership with Valerum and expect that from Q2 and Q3 onwards we’ll start ramping up and be a material contributor to the fiscal year.
So I’ll give you a question about the next two years. In fiscal year 28 we see potentially the impact of both full year impact of Pexelgrastim as well as Ranibizumab that we expect to launch later in fiscal year 27. That should be a material opportunity for us in fiscal year 28. Also we’re 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 28. Plus we have a material 505 apexaban new dosage form that we filed to the agency.
We expect that to come to the market in fiscal year 28. So yeah, a good number of product launches, some exclusive first two files, good impact of the biosimilars and 505B2 starting.
Neha Manpuria
That’s very helpful. And my second question is, I think, you know, there was a Ramesha mentioned about capital allocation. You know, given, you know, the increase in cash balance which will only go up with this, these US launches, how should we think about capital allocation? Priorities. I know, you know, you’ve mentioned this in the past, but just wanted to get a sense of, you know, what we are seeing, you know, in terms of opportunities in the market. You know, what’s interesting you and what are the challenges in terms of not being able to deploy that money.
Thank you.
Vinita Gupta
I mean, we of course would like the right opportunity so we can deploy the capital effectively, but remain very focused in really allocating material portion of our capital to assets either on the specialty side of the business for the developed markets like this Visipharma acquisition, or assets that can complement us in India both in our existing therapy areas as well as bolts to the therapy areas that we want to build. So we continue to be very focused in really looking for assets in the specialty segments that we’ve identified.
Now that we have transacted on busy pharma, 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.
Neha Manpuria
So on the specialty side, the dearth of assets is not an issue. Right. So there are enough and more that that you can look at. So it’s about us selecting the assets that we want.
Vinita Gupta
Yeah, it’s really finding the right assets that from a risk standpoint meet our internal criteria as well as give us enough in terms of potential to be meaningful to grow our specialty business.
Neha Manpuria
Thank you so much. Thank you.
Operator
Thank you so much, NIA, for your question. These are reminded to request all the participants to raise their hands from the participant tab for more questions. In the meanwhile, you can take the next question, please.
Unidentified Participant
Hi. Yeah, hi. Thank you. A couple of questions from my side. Given the settlement, is it fair to assume that in Q4 you have sold significantly more mirabegron compared to Q3?
Vinita Gupta
Yeah, we have had some growth in mirabegron in Q4 versus Q3, but just because of the growth in share, market share or for the generic.
Unidentified Participant
Okay. And the third player who has settled with Astell, have they already entered the market?
Vinita Gupta
No, they haven’t entered the market as of yet. We believe that they’re waiting for product supply.
Unidentified Participant
Got it. And coming to. 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?
Vinita Gupta
Yeah, that is the timeline that we have taken into account in our plans.
Unidentified Participant
Got it. And 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?
Ramesh Swaminathan
No, I think more or less. There will be some PLI coming in next year as well. It’ll come back. Yeah.
Unidentified Participant
Okay. So this quarterly run rate roughly
Unidentified Participant
Is maintainable?
Ramesh Swaminathan
Yeah, kind of.
Unidentified Participant
Thank you.
Operator
Thank you so much, Binu. We’ll take the next question from Damayanti Damenti, are you there?
Damayanti Kerai
Yeah, yeah. Hi. Thank you for the opportunity. My first question is on Visu Pharma. So earlier you mentioned this will add around 50, 60 million euro sales on top line and 25% margin. So 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?
Vinita Gupta
Yeah, so there are multiple areas where strategically the Visu Pharma acquisition adds to us. Number one, geographically, it expands our presence from uk, Germany, France to Italy and Spain, markets that we have had no presence in. And just leveraging the presence across the ophthalmology portfolio, taking our respiratory products, our biosimilars, namuscular 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 Visiopharma 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.
And third, the portfolio also has a fit in other emerging markets for certain. And our team is also looking to see whether we can launch in some of the developed markets. But in Latin America and Southeast Asia, we have the potential of leveraging the Visu Pharma portfolio into these markets. So multiple areas of synergies that our team is working upon. And we remain confident that this is going to be a material step in enhancing a business in Europe as well as on the specialty front.
Damayanti Kerai
Sure. Vinita and the top line should comfortably cross say 100 million mark in two to three years, right? If all these factors play out well.
Vinita Gupta
Yes.
Damayanti Kerai
Okay, that’s helpful. And 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?
Vinita Gupta
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.
Damayanti Kerai
Okay, that’s helpful. My second question is on your settlement for Mira background with Estellas so you had one prepaid component which I believe is sitting in fourth Q4 Q numbers. And on an ongoing basis you will be paying per unit cost. Right. And that will be part of the ongoing operating expense. So if you can clarify on that.
Ramesh Swaminathan
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, it actually gets amortized over a period of time.
Damayanti Kerai
Okay. So any indication like which will be the bigger component, whether it’s part of operating expense or the one which is amortized.
Ramesh Swaminathan
So clearly, you know, so it really depends on the sales at this stage. So you know, the first component is actually variable. The second is just an amortization spread over time.
Vinita Gupta
And we have factored in the additional cost per unit in our gross margin going forward. And the amortization of the 75 million will be in the next two years pretty much.
Damayanti Kerai
Okay, my last question is regarding one product which we earlier discussed. Dalvinson, can you update on the status of that particular product?
Unidentified Participant
Sorry, yeah,
Vinita Gupta
We expect to launch the Delbinson 505B2. We expecting to launch it in fiscal year 2727.
Damayanti Kerai
Okay. Okay, that help us. Thank you.
Operator
Thank you so much. This is a reiteration to request all the participations to raise their hands from the participants tab for more questions please. In the meanwhile we take a 10 second break to have more hands and more tabs. Thank you so much. Thank you so much for your patience. We can take the next question from Vivek Agarwal.
Vivek Agrawal
Yeah, thanks for the opportunity. Couple of questions on biosimilars. One is on Rani Mijua. So how comfortable you are with the economics of this product or if you look at the current market dynamics. Right. The prescriptions have shifted to a flibercep that is a longer duration. And if you look at the existing or the current incumbents. Biosimilars, Biosimilars, they have dropped this product right from the market. So what gives you confidence that this product is going to be a material product for you?
Vinita Gupta
We actually are seeing a good amount of traction with the FDA in getting a product to market. 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. Also I think you’re going to see companies relaunching ranibizumab. So we do believe that while part of the market has shifted into eflibseb, there’s still an opportunity in renobizumab also for us. We have both the pre filled syringe as well as the vial while majority of the competitors have vial only.
So we see also an opportunity for our product to be differentiated in the marketplace.
Vivek Agrawal
Understood, thank you. And is it possible for you to update on pegfail onboardy product? So what is the current status and what’s the launch timelines for this product?
Vinita Gupta
Yeah, so we are pretty far along. We should be able to file this fiscal year and I know we have plan to launch it in fiscal year 29 but hopefully we should be able to launch in fiscal year 28 itself.
Vivek Agrawal
So I didn’t get it. So Basically it’s a FY28 launch or FY29
Vinita Gupta
Launch, one of the two, depending on FDA approval.
Vivek Agrawal
Understood. So you talk about let’s say around four products in the biosimilar. So which are the other two products if it is possible for you to highlight.
Vinita Gupta
So Pexelgrastim and Ranibizumab the obi, which of course is Pexelgrastin but it’s a different dosage form and eflibercept and the fifth one is eternacept in 29.
Vivek Agrawal
Understood. And just again one more question on biosimilars in the next couple of years, what kind of revenues that you estimate from from the sales of biosimilars? Only in the US
Vinita Gupta
We haven’t called out the actual revenues from biosimilars, but they’re meaningful. Each product is pretty meaningful in our P and L going forward we really look at the biosimilars opportunity as a very, very similar to our respiratory opportunity over the next five years.
Vivek Agrawal
Thank you. I have more questions. We’ll join back in the queue.
Operator
Thank you so much. Vivek. We’ll take the next question from Shayan Mukherjee. Yeah, you’re audible. Yes,
Saion Mukherjee
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’ve made.
Ramesh Swaminathan
You know, so if there is further depreciation, obviously there is a benefit that would be that we would be taking in. So what I am is that at a time that we actually constituted the budget, which is about three months ago.
Saion Mukherjee
That is true terms. Yeah,
Ramesh Swaminathan
It’s true terms.
Saion Mukherjee
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. So what’s the annualized impact of the same that you’re seeing on the P and L? If the situation were to remain at the Current level.
Ramesh Swaminathan
So 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. And there are of course issues in terms of raw material costs, availability of chemicals, sometimes low solvent prices and all of that. We’ve estimated that. So clearly we are monitoring it on a very granular basis and take appropriate action in terms of possible price increases, as in when we think it is absolutely something that needs to be done.
Saion Mukherjee
Okay, but will you be able to quantify Ramesh? Like what? I don’t want to
Ramesh Swaminathan
Do it at this stage.
Saion Mukherjee
Okay. So
Ramesh Swaminathan
When we have actually reckoned the 25%, we have actually taken into account all of this as well. So it’s still too many moving parts at this stage.
Saion Mukherjee
Okay. And finally, just one question on your product filing in the U.S. I think you mentioned about on body product, but what about, you know, the respiratory products, Respimat, Ellipta and Enbrel Biosimilar? What’s the timeline with respect to filing for these products and you know, when should we expect launch?
Vinita Gupta
So Restimat is actually in the works right now and will be a current fiscal year filing and the other internacept also will be in the current fiscal year. We pretty much have the entire dossier for Eternacept. There’s very little work to be done to be able to file it. And there are material other products that we are planning to launch for the US we have eight to nine product filings in fiscal year 27 on the respiratory front.
Saion Mukherjee
And Ellipta Vinita, any timeline for that?
Vinita Gupta
Yeah, Ellipta, we are still working on it. It’s been challenging for us but we continue to work on both the Brio and Trelegy products.
Saion Mukherjee
Okay, thanks and I’ll join.
Operator
Thanks Shahid. We’ll take the next question from Kunal Randarian.
Kunal Randeria
Hi, good afternoon. The 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?
Nilesh Gupta
So 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 important market, Brazil as well through partnerships in markets like Canada and the like as well. But these, these three markets will probably start it off for us.
Kunal Randeria
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
Saion Mukherjee
Africa also this year. This year. Brazil also this year. So
Vinita Gupta
Brazil, Canada should really be filing this year. So launch hopefully next year.
Kunal Randeria
Right. So. But the fact is that you may not be on the first wave, so will it still be meaningful?
Vinita Gupta
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 DAPA launch and now EMPA launch, we’re really creating a good position in the metabolic space. We see a good opportunity even as a latecomer and I think in the pure genetic markets it will be tougher. But in the emerging markets it should continue to be an attractive opportunity for us.
Kunal Randeria
The second question on biosimilars, so I understand, you know, you’ll have techfield, Restim and maybe eternocept a few years down the line in the US but the entry barrier now for biosimilars is going down, the cost is going down. So 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 2930?
Vinita Gupta
I think unless there’s a real material shift in the market model, we really see the new entrants bringing an advantage to the overall economics in the biosimilar segment. And 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 are finding in Europe as well there is a more efficient model especially where, you know, 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. So our focus from a pipeline perspective is really on products where we can be in the first wave or limited number of competitors that can give us a unique positioning. We have a good positioning on the ophthalmology front beyond biosimilars, with Visu Pharma and other products that we are planning to bring into the market. So we think it really enables us, you know, as an ophthalmic player to bring in both the affordable biosimilars as well as innovative products.
But 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.
Kunal Randeria
Got it. And Just how big is the biosimilar franchise as of now?
Vinita Gupta
I mean it’s franchise in terms of from
Kunal Randeria
A revenue perspective
Nilesh Gupta
Right now or about $50 million right now,
Kunal Randeria
But
Nilesh Gupta
Slated to time this financial year itself. Yes.
Kunal Randeria
Yeah. So just to clarify, largely it’s from internacept 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.
Vinita Gupta
Yeah, I mean it’s through partners primarily.
Kunal Randeria
Okay. Okay, got it. Thank you.
Operator
Thanks, Kunal. The next question is from Shashank Krishna Kumar.
Shashank Krishnakumar
Thanks for taking my question. The first one was on Spiriba. I just wanted to check hearing anything incrementally in terms of competition there and whether our FY27 guidance sort of any potential generic.
Vinita Gupta
Yeah, 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 27.
Shashank Krishnakumar
Secondly, I think other expenses line at. I think certain acquisition related cost. Was that meaningful? You
Vinita Gupta
Know your voice, voice is going in and out actually. Hello? I can’t hear you clearly.
Shashank Krishnakumar
Yeah. Is this better?
Vinita Gupta
Yeah, much better. Yeah.
Shashank Krishnakumar
The acquisition related cost which I validated to within other expense, was that a meaningful figure this quarter?
Vinita Gupta
Acquisition cost?
Ramesh Swaminathan
Yeah, acquisition cost is also included a portion of that.
Shashank Krishnakumar
Was that a meaningful.
Ramesh Swaminathan
Well, it’s actually part of the overall cost. So there are a host of things that actually goes into as I said other expenses this time around. Now we have in fact in the Mirabeground settlement you’ve got Forex. There’s of course the higher component of R D and there’s of course the MND expenditure also.
Shashank Krishnakumar
Got it. And just the last one on Ellipta. So I just wanted to check with the challenges that we’re facing. Is it with respect to the device? I think one of our also recently entered into a partnership for the device. So where exactly is the challenge? If you could sort of explain what is the hurdle in terms of the final tagline?
Vinita Gupta
Yeah, it is really to achieve the product pk. We believe that we’ve got the right device in place. It’s really the product PK getting that right and refining that the brand itself is fairly variable.
Unidentified Participant
Okay, thank you. All the best.
Operator
Thank you so much. We take the next question from Shyam Srinivasan.
Shyam Srinivasan
Yeah. Hi, good evening. Thank you for taking my question. Just the first one on semaglutide in India. So how has the launch gone? I think you mentioned the top two, top three. So just what were 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, so 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.
Nilesh Gupta
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. So good start. I think we’re the number two company as a generic one, the number three product as a product itself. So good start. But very early days. Right? I mean we’re talking about nine days of data and you know, next week we’ll have, we’ll have data for April as well.
We’ve obviously had substantial increase in primary in the, in the second month. But I mean time will show. But 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.
Shyam Srinivasan
Yeah, yeah. So Nilesh, I remember in our earlier comments we had Talked about the 1500 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. It’s still a very early day.
Nilesh Gupta
I think with GLP ones you’re safe to always take it upwards, but I think the. I think it’s just too early to really predict long behavior. Right. You saw how quickly Manjaro became the biggest product in India and now it’s flattened out. Right. So, you know, how important is it generic? How important is Manjaro versus Hemaglutide? I think there are multiple things to play out. There’s so many other products that are going to come along as well. But clearly this is pretty widely accepted therapy.
The number of prescribers is significant. The number of patients that have gone on to this is very material as well. So yeah, I think this is one of the biggest launches for the industry.
Shyam Srinivasan
Got it. Thank you. Just my last Question just again, back on the margin guidance. Right. So we’re going from 29% this year to 25, let’s assume. But quarterfolk had some headwinds already given that we had a settlement and maybe some of it played through in Q4 as well. So is there extra sprinkling of conservativeness in our margins or you think during the year there could be upside surprises as well?
Ramesh Swaminathan
No, this is actually as a result of, you know, we reckon that there could be some competition coming in for Telvaptin and possibly for Merabiguron next year. So that would actually in some ways impact our overall margins, clearly. So. And of course as you could, as you would see, our R and D expenditure is set to is slated to increase a bit. So that has also been captured in the overall guidance.
Shyam Srinivasan
Got it. Thank you. Thank you, Ramesh. All the best.
Operator
Thank you, Shyam. We’ll take the next question from Vishal Manjinda.
Unidentified Participant
Hi, good evening. On the albuterol inhaler market, wanted to check whether you expect any adverse impact on account of the GSK launch. So they’re supposed to launch a green inhaler around third quarter of this financial year. So do you think the other Albutrol inhalers on the market will see an adverse impact?
Vinita Gupta
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. You know, we’ve been able to tell based on what we learned and we hope that it actually expands the market for albuterol. And you know, we also ourselves working on the green propellant MDIs. So we’re looking forward to see how the launch goes and you know, we’ll track it very closely.
Unidentified Participant
So since you are working on a green propylene too,
Vinita Gupta
It will launch
Unidentified Participant
As a brand or can you launch should need to launch as a brand?
Vinita Gupta
Well, so it’s very early to tell but just given where things are, if we launch after the brand comes in, it will really be a generic green propellant product. If you look at the Ventolin product, it’s not had any genetics so far. I think Cipla is the first approval. So that market has been pretty much branded and GSK has the opportunity of converting it into the new version.
Unidentified Participant
Yeah. And another one on the enabler side. Are we planning to file Symbicod and Adware or we we don’t intend to do do those products.
Vinita Gupta
We do have Symbicord in our pipeline and we have Advair HFA also in our pipeline.
Unidentified Participant
Hfa. Okay. Yes. And any filing timeline,
Vinita Gupta
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.
Unidentified Participant
Okay. And 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 construct.
Vinita Gupta
Yes. So 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 at a CMO and have struggled to really ramp up. I mean, you know, the brand actually has had supply issues as well. So there has been an increased demand in the marketplace that they’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. So 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. 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. So at this point in time we have multiple products on for other brands in the platform and have a few conversations ongoing on potentially doing innovative product transactions with the platform.
Unidentified Participant
You mean doing your own innovative products or kind of doing that as a CDM or partner?
Vinita Gupta
So 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 long acting versions of their products.
Nilesh Gupta
Ask you to get back in queue, there’s a bunch of people waiting and maybe we should go a little quicker.
Kunal Randeria
Thank you.
Nilesh Gupta
Thank you.
Operator
Thank us. Can we have Kunal Lakar for the next question please? Or Vivek, you can come in. Vivek Agarwal for the next question.
Unidentified Participant
Hello, Vivek, are you there?
Vivek Agrawal
Hello?
Unidentified Participant
Yeah,
Vivek Agrawal
Yeah, thanks for the question. Just one clarification on the products Toloptan and Mirabegron. So you talked about that Mirabeground competition possibly next year if I heard right.
Vinita Gupta
That’s right.
Vivek Agrawal
So you are not expecting, let’s say any additional competition in FY27 in this product?
Vinita Gupta
No, FY27 is next year for us.
Ramesh Swaminathan
This current fiscal is what he meant.
Vivek Agrawal
Okay, okay, understood. And Just one question on the overall US business. Right. We have done close to 1.3 billion dollar of revenues this year. And then there are a lot of moving parts. Couple of products will come down in FY27 and then we will see some kind of additional competition, additional erosion in FY28 as well. So it would be helpful actually if you just give some number, ballpark Number of US revenues for 27 and 28 to work with. Thank you.
Vinita Gupta
Yes. 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 Tulvaptin, we should be able to get to a level compared to the current year where maybe it’s high single digit or low double digit erosion in terms of revenues. And that’s of course a combination of the current products as well as new product launches. With our injectable launches as well as with Pexel Grastem, we expect to offset some of the erosion and we expect our base business also to grow in the U.S.
Vivek Agrawal
Understood. So if I heard correctly, right, so in FY28, if you are expecting that U.S. Business to be a billion dollar plus. Close to billion dollar plus. Right.
Vinita Gupta
In FY27 to be a billion dollar plus.
Vivek Agrawal
Understood. Thank you. That’s
Shashank Krishnakumar
From my side.
Unidentified Participant
Thank
Operator
You very much.
Unidentified Participant
Last question. Okay, I think sure. We take one more questions.
Operator
Hello? Yes, we can.
Unidentified Participant
Hello? We’ll take the next question from Forum Parikh. Forum, are you there?
Operator
Go ahead, Forum.
Unidentified Participant
Hello?
Shashank Krishnakumar
Not audible.
Operator
Yeah, she’s not. We’ll close it.
Shashank Krishnakumar
Yeah.
Operator
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.
Vinita Gupta
Thank you. Thank you friends for all your questions. Hopefully we’ve been able to answer all of them, otherwise 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 26 and continue to work hard to be able to exceed both our expectations as well as the market expectations in fiscal year 27 and beyond. Thank you again.
Unidentified Participant
Thank you.
Operator
Thank you, ma’. Am. On behalf of Louisville Limited. That concludes this conference. Thank you for joining us and you may now exit the webinar. Thank you.
Kunal Randeria
Goodbye.