Refused to commit on fy26 top line guidance.

On the nano paclitaxel launch in U.S., how are we looking at this market given other 505(b)(2) players, how are we positioned to gain market share, and any technicalities regarding channel of selling?

There is 1 NDA player and 2 generics; one of the generics will continue to expand for ANDA generics because they are substitutable. From a reimbursement perspective, everybody is reimbursed like a generic. We feel the market is large enough for us to take meaningful share.

What would be your estimate of the total addressable market now?

The market was $800 million, $900 million pre generic. The IMS would still show it at that level, but there would be a gross to nets to bring the market down which on the institutional side is closer to the overall IMS reported number. Our belief is that we should play for fair market share on this product category.

I missed any commentary on Advair, and overall on the respiratory pipeline.

Advair will be commercialized from our site in the U.S. We've taken our batches and gone through the regulatory process. Depending on how the U.S. prioritizes domestic site filings, we definitely see it as an FY '26 launch, either in the early part or later part of the year.

So we have filed an amendment to ANDA, right, and not the CBE-30?

It can't be a CBE-30 because it's from a new site. So that filing has already gone where it is filing from a new site. There was a recent promulgation from the U.S. that filings from domestic facilities may be prioritized.

On potential pharma tariff, any update on the U.S. market from your partners or distributors?

We have not got impacted by any in our portfolio - this is an evolving situation. The most recent announcement doesn't really impact the generic players. In fact, it may just benefit.

Which product will prefer, NDA 505(b)(2) or NDA in terms of gaining market share quickly?

The ANDA always gains share faster because it's just like the brand product. But we are selling both right now.

Comment on R&D outlook - in '26-'27 how should we look at R&D cost and which are focus segments in near term?

We're generally in the range, guiding to never higher than 6, 6.5% on a full year basis. Some quarters may be slightly higher, some lower. Focus areas continue to be respiratory, injectables, India products including GLP-1s going off patent.

On the margin guidance - is it lower because Revlimid number will be lower or because Revlimid has started seeing price correction in last 12 months?

Revenue will continue in growth trajectory. It's a mix that is likely to change. Generic Revlimid will go out of exclusivity towards the last quarter, which will have an impact on overall margin. That's why we are guiding towards the margin number we've given.

What is the capex thought process for FY26, and how prepared are we for peptide/GLP opportunity? Also overall respiratory revenue share?

Capex is increasing strategically - oriented to respiratory capacity in MDI, DPI and rescues, plus derisking outside India (China facility capitalized, US facilities for MDI/DPI). On GLP-1 we'll be ready for first wave - both in-house and third-party partnerships. Respiratory remains 30% of revenue globally; capex about 5% of revenue.

On India market growth, what's your overall sense on market growth and what trade generic and branded generic growth for Cipla could be?

Overall market growth rate range of 10 to 12 has now moved to 8 to 10. Reasons: NI season of off-patent expiries is gone (lose 1-1.5%), and lower inflation reduces pricing adjustments by another 1-1.5%. Cipla will do better than that overall in India.

In trade generics, have we regained all the lower volume so it's fully back to normal?

It is fully back to normal, and the whole distribution channel is now completely internalized to Cipla.

On capital allocation given the cash you are sitting on, has there been any changes in priorities to deploy that cash inorganically?

India remains our growth market with good return on capital. We'll continue to look at small to large M&A opportunities including product portfolios. Second is adding to U.S. portfolio via partnerships for complex ANDAs/NDAs. EMEU we look at midsized opportunistic acquisitions. We've also maintained the dividend increased in last 2 years.

On the partnered inhalation asset filed a few quarters back, are we on track to commercialize next year and which facility is it filed from?

The asset is on track for commercialization. It was originally filed from Goa and will be commercialized from Goa. We're also creating a new filing/supplementing the file to have the option of doing this from our U.S. facility.

Did the trade generic business also grow in double digits this quarter like Consumer Health?

The trade generic business did not grow as much as the Consumer Health business. It did not grow double digit. Ashish added that the model change impacted Q1 FY25, so Q4 was a normalized quarter of FY24 - YoY growth in trade generic is a normal growth.

On the schedule extension given up to 31st December for MSMEs - can that be a tailwind for trade generics and branded generics growth?

We don't see that as a big driver for our growth. Not having the ability creates more uncertainty in the market. We don't see that as a big tailwind for us this year.

On recent U.S. regulations - does the most favored nation policy create any impact on the specialty part of the portfolio?

We don't have too much share of new drug spec. The focus of the legislation is on new drug NCs and new drug products, not on simple 505(b)(2)s which are reimbursed like ANDAs. We don't have those new drug products.

On the U.S. pharma-related situation evolving, will it affect U.S. business or do you not have any challenges?

Two things in the U.S.: tariffs - currently no tariffs on generic products from India by and large, so we're not impacted. The recent executive order on pricing reductions - generics is a beneficiary as it creates a market where generic drugs are preferred. We're not seeing it impacting our business.

Are we still expecting to launch Symbicort in FY '27?

FY27, yes. We should hopefully be there.

With Lanreotide coming back, are we looking back to peak U.S. run rate of $250 million a quarter starting next quarter?

If lenalidomide stayed where it was, we would have got there and crossed it. But we will see compression in lena over next 2-3 quarters offset by new products. We are looking at something like $220 million for the U.S. going forward in the next quarter.

On Lanreotide - by Q1, do we have enough product in the channel to reach previous market share?

We did not say enough product in the channel - we said we have resumed our supplies back. The channel does not have too much product of Cipla because we are getting back into the business. We are projecting enough supply to start building towards that range.

So our revenue ramp up would be more or less in line with our market share ramp-up?

We are at a stage where we are beginning to produce roughly the same levels we used to produce when we had the prior market share. To go through that market share, because we have to keep stock spare and fill the channel, it will take a little bit of time.

On semaglutide in India, will you pursue both target and injectable versions or only one?

We will be in whatever variant forms for the market. It will likely be the injectable first. As and when the market opens for the oral, we'll also be there in that.

On the executive order, when does it get implemented and how does it affect generics pricing?

Right now it doesn't affect pricing on generics. The executive order is more towards branded drugs. We believe that in the long run, generics will be a beneficiary - if branded prices reduce, branded companies have less interest in massive promotion, and newer drug categories may move over to those already generic.

Of your 29% North American sales, what percentage is supplied by your facilities over there?

About 25% comes from U.S. - mainly orals, adding MDI and DPI. About 1/3 comes from India currently. Balance is CMOs. Umang clarified: for the 29%, about 10% will be made in U.S., 10% in India and 10% in rest of the world.

On India 7% YoY growth, is it largely attributable to volume growth?

It's a mix of all 3 - volume, pricing and new introductions. I don't think it's all volume.

On China plant - what does it supply and to which region?

It's a respiratory plant supplying respiratory medication. Built with the intention of supplying the China market and other markets that require that product, including the U.S. if required.

Will this China plant include the future filings for the U.S.?

Not really. This is only for the current filings. The future filings are going out of our sites in the U.S. and India. The China market itself is also quite big for the products we manage.

On semaglutide, have we filed for Canada or Brazil market? And on Revlimid, do you get any volume increase this year?

On semaglutide - no, we have not filed in Canada or Brazil. On Revlimid, there has been volume increase very marginally for us compared to other players who have commented on larger volume share. For us it's very marginal as per the agreement signed.

On Europe, emerging markets and South Africa - has something really changed in these businesses given strong recovery growth?

South Africa had three levers: Actor acquisition helping OTC growth, opportunistic tenders, and new launches with higher than competition share. On a normalized basis we should take 4-5% growth for South Africa. EMEU is multiple markets - we focused on execution achieving 15% USD growth and it has entered growth phase, target to grow next year as well.

On the large asset for FY26 - what is the expected timeline for approval?

We have 2-3 peptide products expecting this year. We've recently been given approval of nano paclitaxel and a few others in pipeline. We're hoping these approvals can come in the second half. You will see the full impact of a lot of these products in our second half year numbers.

On inhaled insulin approval, what's the opportunity size, how will you price versus injectable insulin? Globally the asset hasn't done well - how can it work in India?

Launch should follow in 3-4 months with a market plan. Inhaled insulin is never to replace existing insulin in India - by its very nature it's a niche asset for people who cannot or are hesitant to take injectable drugs. It's not a mass product - intended to serve a section of population with unmet need.