Thank you very much, sir. We will now begin the question-and-answer session. Please raise your hands from the participant tab on the screen to ask questions. We will wait for 30 seconds for the queue to assemble. Thank you. So, the first question is from Bansi Desai. Please go ahead, ma'am.

Thank you for taking my questions. So, my first question is on the U.S. business, so while Spiriva looks like has contributed meaningfully in Q2 and so has Darunavir, if one were to exclude these two products , have you seen sequential growth in the U.S. base?

Yes, actually we have seen our inline products pretty stable, growing a bit and the new product launches contributing as well. I'd say Darunavir was launched in Q1, so there was pipeline build in Q1, so the Darunavir level in Q2 is obviously lower than Q1.

Okay, that helps. And what is your sense on the price erosion levels in the market, any different from what we saw in Q1?

Yes, we've seen a level of stabiliz ation at that mid -single-digit level on our baseline products, in line products. So hopefully that continues.

Got it. And secondly, on Spiriva itself, our initial expectation was that this product probably will see ramp -up similar to what we s aw in Albuterol, but clearly it looks like, it has done better than that. So, how should we look at market share ramp-up here and any visibility on the AG launch?

Yes, so the ramp-up has been pretty much along the lines that we anticipated. We expected that it would start at 20% -25% level, and then as we looked at other analogs, Advair and other inhalation products, over a year or so, build up to 35% -40% level, and we're seeing that right now. Our substitution rate is 25%. So, it 's hard to predict when AG would launch and if AG would launch, but at this point we are just working hard to keep up with the demand as well as make sure that we scale up the business effectively for the product.

Got it. I have more questions, I'll join back in the queue.

Thank you very much, Bansi, for the question. We'll take the next question from Neha Manpuria.

Thanks for taking my question. Vinita, if we do think Spiriva ramps-up to 35%- 40% market share in the nex t year. A, would this require, in your view, more pricing action from us, to go after this market share? And second, if that is the case, should we then expect the current base that we've reported to see a step-up over the next few quarters? Because in you r opening comments, I think you mentioned that we'll keep the base at 200 plus, but shouldn't we see a step-up from the current base if we get to the 35%-40%?

Yes. So, Neha we would expect pricing to be stable as we ramp-up the product. We don't see any additional entrants in the near -term. So, we don't see a reason for price not to be stable unless we see, a challenge in substitution. But like I said, substitution is along the lines of what we had anticipated. So, it's been a very effective launch from our team. I'd say that, in Q2, we have some effect of the pipeline fill on Spiriva that we're continuing to see in Q3, but we think it might level off a little bit as, other inventory with our customers, gets into sync with the product substitution. And, therefore, we think that, certainly Tiotropium will continue to ramp -up, especially into the next year. But when we look quarter -after-quarter, we might see some impact of inventory correction over the next couple of quarters. And, as we also lose exclusivity on a couple of other products where we have exclusivity, we might see some downside. Of course, we have products that help us grow the business, which gives us confidence that both in fiscal year '25 and in particular in fiscal year '26, given the Tiotropium ramp- up plus injectables plus ophthalmic products that we have on the new product launch calendar, we should grow the business pretty well.

Got it. And, I remember you once mentioning that, you think you have enough capacity to get to your fair share. Should I assume the 35% to 40% is the fair share that you were talking about and, capacity is not an issue, therefore you've given that number?

Yes, we have built capacity not only for the U.S., but also for our other markets. So, in the next 6 to 12 -months, we expect to launch in Australia, Canada, Europe, multiple regions that we built capacity for. So we are well-positioned.

Got it. Ramesh, on the, cost side, I understand that the employee cost obviously has gone up this year with the MR addition that we've seen. But the other expenses also seem to be, inching up. It went up last quarter on a quarter-on-quarter basis. It's gone up again this quarter, on a sequential basis. Other than the SG &A spend associated with the India business, is there anything else that we are investing in outside of R&D which is leading to this quarter-on-quarter increase?

Firstly, I would like to stress that you should see this, vis -a-vis the pr evious quarter where there's, of course, been an increase of, operating leverage of just about 1.2%. But going on to on a year -on-year, yes, there has been, an increase which is close to 26%, but I would also rush to add that you should look at the level o f activity, in terms of, the volumes of API and formulations that have grown significantly. That's actually kind of reflected in the inventory build-up, and that actually translates to in slightly increased, gross margins, which in turn kind of, reverts back to a higher increase from our expense base itself. But I would also again add that, there is, of course, an element of one -time expenditure, which is also contained in here. So, our focus on driving down costs is still very much there, and we expect to kind of keep it on a leash around the levels that we just spoke about for in the quarters to come.

The one-time expenditure is, is captured beca use of essentially the expenses that we incurred on the CDMO spin-off, essentially the stamp duties and other costs we incurred on that. And we also took some provisions, relating to some issues that we had out here.

So what is the base, cost, excluding all of these one-offs, just to get a sense of what the fair number should be going forward?

I would say that it should be closer to the 30% mark.

Including all of it?

Yes, around that, so gi ve or take based again on the level of activity and the like.

Got it. Thank you so much.

Thank you so much, ma'am. The next question is from Damayanti Kerai. Go ahead, ma'am.

Yes. Thank you for the opportunity. Af ter a remarkable improvement in first half in terms of operating performance, how should we look at margin trends ahead? So, as you said earlier expected 18% margin by end of this fiscal but it came a bit earlier and now things seems to be on improving path. So how should we see margin trajectory from here on?

So, we think, in so far as America is concerned, the overall, the sales there should hover around, the $200 million mark and they would of course be ramp- up in other parts including India. So I would actually expect, the growth trajectory to kind of continue and the second half would also be around the 18% mark, in the third and fourth quarters.

So, second half broadly around 18% margin.

Yes.

It's obviously because the first three quarters are in the 18% and 14.5% in the first quarter, you can average it out.

Okay, and just want to understand, ma'am mentioned in her opening comment that now $200 million plus level is sustainable for the U.S. business and that includes Spiriva and all other new launches, right? Or how should we look at that?

That's right.

Okay, and just another question on U.S. side, how much is branded portfolio contribution right now of the total U.S. sales?

It is small, it's under $5 million for the quarter.

Under $500 million, okay.

$5 million.

$5 million, okay. Ye s, sure. And my last question is your presentation mentioned you are building up quite well on the complex project side, 40 plus injectables and then 20 plus inhalers et cetera. In next say two to three years, how many filings we can see on the complex opportunity side? Inhalers, injectables et cetera, and if you can also call out some near -term key filings which you are expecting.

Sure, so majority of our R&D focus has been on the complex generics, in particular inhalation and injectables, ophthalmics as well as first to files, exclusive first-to-files in particular. And we have got a good pipeline in place right now to drive the business growth towards complex generics. Already a good part of it in the U.S. is now respiratory. But as I look at the next two years with the pipeline that we have in place, on the ophthalmic front, given the Pithampur Unit 2 clearance, multiple ophthalmics, five or six products that we expect to bring to market in th e second half of this fiscal year as well as into the next fiscal year . We have products like Bromday, Bromsite, Loteprednol, Prolensa, all that we're expecting approval for and then launch over the next couple of years. On the injectable front, we have a good pipeline now in place, multiple products in development, a few products that we expect to launch in the current fiscal year. We think Ganirelix, Famotidine will launch this fiscal year and then next fiscal year we hope to launch Glucagon. That would be a material one for us and then depending on litigation outcome also, Liraglutide in fiscal year '26. And then lastly, I would say on the injectable front, Risperdal Consta, a long-acting Risperidone out of Nanomi should come to market by fiscal year '26. So, both opthalimics and injectables ramp-up in the second half of this year, but more so in fiscal year '25. And then, also the first-to-file oral solids like Tolvaptan in fiscal year '26. We're very pleased to get that approval in October, our goal date, As well as, products like Mirabegron and Oracea and Doxycycline. we expect both approvals as well as litigation outcome over the next couple of months that will enable us to confirm launch dates, but we expect to launch in the next, two years.

Okay, that's helpful. Thank you very much.

Thank you so much, ma'am. The next question is from Karan Vora. Karan, you can go ahead.

Yes, thank you for taking my question. So my first question is on the India business. So, going forward, assuming the IPM grows at, say, high-single-digits, do you think even on a base which has the in -licensed diabetic product which went off patent, we can still outperform the IPM over the medium -term, or it will be slightly tall?

Yes, Karan, that's clearly the plan. The plan is to continue growing it better than the market. Diabetes is the one category that has been a challenge for us, but that also has come around to growth now for us. So, certainly we would expect growth to continue better than the market for the mid to long-term.

Okay. And how do you how do you split this or say if you grow at 10% how do we split that out into price and volume?

Okay, thank you. Second question on Spiriva. So just needed some clarity. So, basically is this understanding correct that because this was the first quarter of launch there would be some amount of channel filling and so Q3 and Q4 the amount of Spiriva which you book would be lower than Q2. So that could impact your U.S. Q-o-Q growth or is that understanding, correct?

Yes, there may be some phasing. We're still tracking it very closely. So , we'll find out over the next couple of months. But we would expect that there will be some levelling off in the next month or so.

Okay. And just two quick ones on U.S. business. So , any update on Revlimid launch?

That is out a c ouple of years for us. So , it's, I think, fiscal year '26, if I'm not mistaken.

Okay, and lastly, at the current run rate, is the U.S. business EBITDA and PAT breakeven or not, if you could give some qualitative sense? Thank you.

It is EBITDA accretive to the company average margins. And, we hope that we'll continue at this pace and improve further as we, ramp up the business.

Yes.

Thanks, Karan. The next question is from Kunal Dhamesha.

Thank you for the opportunity. First one on the biosimilar, is there any update on the Pune facility and Pegfilgrastim filing for us?

Yes, I can take that. So we had the EIR, which was issued by the FDA. We identified areas of improvement in the EIR, which were actually underway. And we hope to send an update to the agency by March, post which we would follow up for an approval.

Yes, so we're tracking the market very closely right now, and of course, waiting for the site and product approval before making concrete plans. Bu t, as the market evolves, the access model gets a little bit simpler as we see it, with established channels in the marketplace. So, we are constantly tracking, and plan even with a direct -to-market salesforce effort to really have a very targeted niche s alesforce that can double-up with our injectable business, so we can have some operating leverage as opposed to having a single product investment. So, watching that carefully, and we also have, apart from our own plans and potential to launch, we also have interest from partners. And we're going to closely track our OBI product development to determine what is the best route for us to go.

So, and any update on the Ranibizumab and that is also something that we are developing, right?

So, on Ranibizumab, we are well on our way on our clinical trial. We've got the last patient in; it's still going to be about a year to do the filing itself. But this is the clear filing for the next fiscal.

Sure, and the second questi on is on the seasonal product uptake in the U.S. Typically during this time around there is flu season and we have Cephalosporins as well as Tamiflu. So have we seen any uptick, in this quarter or probably we could see it in next quarter.

We've seen some uptake in this quarter in anticipation of a flu season and the season has just started, so we just started the last couple of weeks tracking. So it has ramped up but we'll have to really get into the next month or two to see how strong the flu season is going to be and it certainly has ramped up but it's at a level below last year right now.

So, like-to-like, it's level below at least from October and November is the way to look at it.

That's right.

Thank you. Happy Diwali to you as well.

Thank you Kunal. The next question is from Nitin Agarwal.

Hi. Thanks for taking my question. See Vinita when we talk about 25% market share on Spiriva, we take into account the entire portfolio of Spiriva, Respimat inhaler and HandiHaler both are we just talking in terms of the single strength?

I'm talking about the HandiHaler.

As a percentage of that market. But how do you see the substitution happening from Respimat inhaler? I mean, how do you see that playing out?

Actually, the encouraging sign for us was, in the last couple of years, we have seen the HandiHaler decline versus Respimat, that the brand has been working hard to convert. They had also moved their couponing strategy to the Respimat to drive hard conversion. We actually saw in the last couple of months a flattening of, so no decline in the HandiHaler, which is a promising sign. And we hope that as we continue to ramp-up the product as it gets utilized, that it will definitely flatten the decline or, hopefully take some share from the overall molecule.

And secondly, you talked about, U.S. st abilizing around $ 200 million now. When you take a two year view from here on, I mean, where do you see the next milestones, something like $250 million thereabouts, when you start to hit that at a consistent level?

I'd say that, next year is going to be a ramp -up year for us, both with Tiotropium as well as the other product launches. And certainly, fiscal year '26 is one where we see with, on the strength of the new product launches . Tolvaptan is going to be a material one for us. Potentially Liraglutide depending on of course approval as well as litigation and the opthalmic injectible ramp - up. We expect to be at that closer to the $250 million a quarter.

So, when is the Tolvaptan launch? What timelines are you looking for that, potentially?

Okay. And last one, we've seen a reasona ble ramp-up in our non -U.S. export geographies, across a bunch of these geographies. Any color on, the kind of scale up which has come through and where, where are these from profitability perspective and contribution to our overall profitability as we go forward?

Certainly. I mean, apart from the U.S., when we think about, apart from U.S. and India, Europe has been a very strong contributor this fiscal year so far, and we expect that to continue over the next couple of years. Likewise, Austra lia, Canada, all of them had a pretty strong run rate over, over the last couple of quarters driven by complex generics. I mean, if you look at Europe, Fostair generic has become our largest product there, and we're continuing to ramp it up. So, respiratory has become a big part of the focus in Europe. In Canada as well, we're looking forward to launching Tiotropium soon. Australia as well, we expect to launch Tiotropium soon. I believe, we are under- indexed right now in the ex -U.S. developed markets . Our complex generic portfolio inhalation, also biosimilars and injectables really will enable us to grow these markets as well. So, they become a larger part of the company over the next two to five years.

So, this group as a whole, can it sort of compound in mid-teens over a period of time?

For sure. Already, Europe has ramped up. Canada and Australia are already at a good level. So, we would expect them to be in the mid-teens.

Last one. In fact, on the Consta product, where are we on the filing and approval process? You talked about '26 launch on that.

We are filing it this month. It's in the final stages of the filing. And we would hope by fiscal year '26, as that gives us a couple of cycles to get approval.

Thank you so much, and best of luck. Happy Diwali to you.

Thank you so much, Nitin. We'll take the next question from Bino Pathiparampil.

Good morning and good evening. Hi, Vinita just a follow-up on Spiriva, you had mentioned earlier that you're seeing a substitution rate of 25%. How is this defined? What does that mean?

That's a prescription ramp-up rate that we are seeing of the generic versus the brand HandiHaler.

Okay. And how, one bottle or one canister, however you call it, how long does it typically last for a patient? One month, two months?

I think it's a 60-day supply if I'm not mistaken.

It's a 30 day.

30 days.

30 days. Okay. So if substitution rate is 25%, then 30 days we should be hitting 25% market share, right? I mean, am I, is there something wrong in that assumption?

I think so, that’s just right.

Okay. And second?

That's the kind of unit share, we are seeing the unit and prescription share, coming close together at this point.

Okay. Are you talking this about only new prescription? I mean, people going for refills are still, the substitution rate is not that high. Is that the case?

No. We are seeing overall substitution, not just NRX.

Yes, Okay. Understood. Second, a follow -up on Mirabegron, you mentioned that in a couple of months you are expecti ng some litigation outcome, which will decide the launch date. So , could you let me know, in case the litigation outcome is favourable then what could be the launch date and if it is unfavourable then what could be the launch date?

So, we have prevailed on one major patent in litigation in the district court that's on appeal right now. We have settled on another and the brand has continued to file patents that we have been battling. We are actively working on our litigation strategy to determine how soon we can launch.

Okay, so what is the earliest possible o r the latest possible? Is there a range that you can give?

I wouldn't be able to share an actual launch date. It's fair to say that we are actively working on this one and the fact that we won on the major patent was very heartening for us, gives us confidence of our ability to launch.

Understood. Just last one on Nascobal and Diastat. Are these now already kind of part of the base? Is it currently in Q3, or we are yet to ramp up?

No, so we are yet to ramp up. Actually, Diastat we launched last week. It was a fairly challenging product, but the team has launc hed it effectively. And Nascobal we expect to launch in the next week. So , both of those will contribute to the growth in Q3 and Q4.

Thank you. I'll join back in queue.

Thank you.

The next question is from Sanjay Khullar. Sanjay, you can go ahead.

Okay. First of all, I would like to compliment Vinita for delivering excellent results. I have a couple of questions. Madam, where do you see our company in over next two, three years, as you mentioned that we are on a steady growth plan. So next target is $5 billion, maybe three to five years down the line. Second question is, when do we surpass the record profits achieved during Shri DBG’s times, we achieved record profits. So when do you see w e achieve this in next two, three years?

Very good questions. Both the long -term prospects on the revenue front and profitability, and our goal is really to get our company back to consistent growth on revenues as well as improve our profitability, so profitable growth more than just growth. So, on the revenue front, we see, I mean, fiscal year '26 is going to be a material year for us, as I mentioned in the last couple of minutes, given the material launches, as well as ramp up of current prod ucts, continuing to solidify the gains that we have made. And then I'd say in a five - year time frame, we expect the overall company business to grow substantially.

Yes, fantastic.

And both across the U.S., as well as India, and as well as, other parts of the developed markets that we are currently under -indexed on, they should be a larger part of our business in five years. I'd say on the developed market side, U.S. as well as Europe, Canada, Australia We would see majority o f our portfolio, two -thirds of it switching to complex generics based on the investment that we've made and the execution so far, inhalation, injectables, really contributing a material part of our growth over the next five years. On the profitability front, we have come a long way over the last year and a half, still a long way to go. Our highs of 20 margins certainly are aspirational for us. Right now, we can see a path over the next few years to get to a good 20% plus. Mid 20s is our goal, to really close the gap with our peers. There’s no reason why we should be below that. But as we continue to look at the company prospects beyond five years and look at investment plans in particular in areas like specialty, which long -term are our aspiration for our organization. We'll have to determine what kind of investments we make. So, we'd hope to get to 20% plus, then the mid -20s and then we'll determine what's the best way to grow our organization for the long-term.

Okay, and one last thing, madam. I used to meet DBG when I used to be a friend with him. He used to say Lupin will be number one pharma company from India. So, I'm sure your dream will also be that. So, do you see happening in next five years, seven years down the line, madam?

What we are, given the complexity of our business across globe, India being a big part of it, U.S. being a big part of it, and our chosen strategy of going into complex generics as opposed to a broad -spectrum generic company, I would say that, at this point our focus is to be the best in what we do. We want to be a leader in the areas that we have chosen, so like respiratory is one that is turning out to be one of our biggest growth drivers for the organization globally. We're already a big player in India, and we want to be, a material player ex-India as well. It's a big part of our business in the U.S., as well as a growing part in other parts of the world. So, I'd say, the areas that we choose to be in, we'll target to be the best.

Okay, madam. Thank you very much and wish you a Happy Diwali.

Thank you. Happy Diwali to you as well.

Thank you.

Thanks, Sanjay. Before, we proceed, just a reminder to all the participants to raise your hands for further questions. We’ll take the next question from Ankush Mahajan.

Thanks for the opportunity. Ma'am, we have U.S. revenue in the range of $211 million now. So, this run rate, could you give me some sense of what kind of a run rate that we can expect in upcoming quarters? Because you already have inched to $211 million from $181 million.

Yes, I mentioned $200 plus million is what you should expect.

For the upcoming quarters.

That's right.

Thank you, ma'am. Thanks.

You're welcome.

Thank you, friends. Thank you for all your questions. And as we mentioned, we are very excited about the progress we have made so far. We look forward to a very successful second half of the year and building from there into the next two fiscal years. So, look forward to strong quarters ahead and reporting the same back to you, all of you. Given the holiday season, wishing all of you a very Happy Diwali and a prosperous new year. Have a wonderful holiday weekend and look forward to speaking with you again next quarter. Thank you.

Thank you so much, ma'am. So, on behalf of Lupin Limited, that concludes this conference. Thank you for joining us. And before we sign off, here's wishing all of you all a very Happy Diwali. And now you may exit the webinar. Thank you very much.