Throughline · holding view Deep analysis Q1 FY26
CIPLA Cipla · Pharma Q1 FY26 · concall
Pattern: biosimilar partner product competitive

FY26 closed 21% EBITDA matching Q3 cut.

2 deflections · 8 weak · 21 clean pushback across 10 of 31 Q&A turns

Focused evidence 10 of 31

Kunal Dhamesha · Macquarieweak

On the imminent biosimilar launch where we have a strategic agreement with a partner - who is the partner, what product, competitive landscape, Cipla's role and economics?

Our partner has made a disclosure. The product is in supportive therapy - the segment of supportive care in oncology. It's filgrastim and the partner has disclosed this in their release. There are many other players in this category of the market.

Tushar Manudhane · Motilal Oswal Financial Servicesdeflection

On U.S. sales, given good launches, would we be able to maintain this annualized run rate of $226 million for FY '26?

It's a little indeterminate and depends on when the impact of Revlimid comes off - it could be in quarter 3, quarter 4 or quarter 2. So it's very difficult to give a guidance range. But we are sticking to what we said at the beginning of the year for an overall U.S. trajectory and growth. On a full year basis, we believe that our margin should come into the range that we have set.

Damayanti Kerai · HSBCweak

On Lanreotide, we have seen good pickup. When do you see it going back to the level you have come off? And how do you see market share gain - is there sufficient visibility to gain more share?

It's a 2-player market right now. We had the problem with our manufacturing, and before that issue we were at 30%, 35% of the market. We are evaluating the market on fair share from a value perspective. We intend, over a period of time and not immediately, to reach a more respectable share of the overall market.

Surya Narayan Patra · PhillipCapitalweak

On our GLP plan, what is our strength about this product opportunity, our plan, are we playing on cost position, distribution strength or market reach? What kind of TAM are we targeting?

For us, the entire GLP-1 category is more important than just looking at individual products. Our endeavor is to be among the first wave of launches for the GLP-1 drugs. We have parts of the chain that we have internalized and parts that come from a partner - a mix and hybrid strategy. We're trying to maximize the opportunity in total between managing our own supply chain, partner supply chain, and even taking a hard look at GLP-1 as a category against just a single product.

Surya Narayan Patra · PhillipCapitalweak

Will GLP-1 be a significant driver of growth for domestic business in FY '27 itself? And will we be in the first wave of Canadian and Brazil launches?

Yes, hopefully. If the market forms early next year, it will be a significant growth driver for the business. On Canada, we will not provide that level of color - the Canada opportunity for some of our competitors is real, but we are not in the first wave launches in Canada that we are sure about. For some other markets, we will be among the first set of launches.

Neha Manpuria · Bank of Americaweak

On margins, given U.S. pipeline mentioned, shouldn't margin be higher than the guidance range we've given? And for next year if we get to $1 billion U.S. sales, can we keep margins at 23.5% in fiscal '27?

No, I will stay with no. We optimize the margin out here with product mix and other expenses targeting. This is despite our R&D expense being higher this quarter because of certain R&D APIs procured for developmental efforts. We had also expected that in line with Revlimid, the first quarters 1, 2, 3 would be higher than the balance of the year. A little early for us to give guidance for next year - closer to the year-end when we're in a position to give that guidance.

Bino Pathiparampil · Elara Capitalweak

Has Revlimid changed Q-o-Q over the last 3 quarters - Q3, Q4, Q1? Or broadly similar? And should we read that this year's total U.S. will be similar to last year's despite Revlimid only being there part of year?

On Revlimid value this quarter versus last one - that's more or less the same. On the launches: your launches will come at different time lines, so it's difficult to say in terms of time lines. But we have plans for all our launches that are coming in to make up for the revenue loss from Revlimid. That will happen in a short to medium term.

Maitri Sheth · Choice Institutional Equitiesdeflection

Given we have 19.5% market share in albuterol, what kind of revenue outlook can we expect from this drug? How much is it contributing to North America revenue currently?

We don't give out molecule-wise data. It's one of our strategic respiratory assets in the U.S. and we would like to maintain the market share out here. And if capacity allows us, then we'll obviously grow that as well.

Sidharth Negandhi · Chanakya Wealth Creationweak

On GLP-1s and semaglutide, given Cipla's relative competitive strength is in other therapies and diabetics is smaller percentage of sales, how do you see a path to creating superior right to win and differentiation?

We do think the GLP-1 market will be crowded. The way you make portfolio choices here will perhaps be the most important. We are looking at GLP-1 as a full category as against just sema or other variants within it. So that's how we plan to play this market.

Saion Mukherjee · Nomura Securitiesweak

On initial market share for new launches paclitaxel and Nilotinib, how big are these 2 products likely to be for Cipla in fiscal '26?

On Nano Pacli, there are 2-3 players already, with 2 selling the same innovative product and the other 2 are 505. Price is not the same as innovator price. I can't give a ballpark estimate but the market is big enough to accommodate perhaps more vials than what we can produce. On Nilotinib, the market opportunity may be more limited - the B2 will have a lot of relevance when there are not too many ANDA players, but once more ANDA players come, B2 opportunity goes down. The B2 opportunity will probably maximize itself in the first 6 months.

Other Q&A (21)
Kunal Dhamesha · Macquarie

On the U.S. business, given price erosion in Revlimid, how does our outlook on U.S. business growth remain for FY '26 and FY '27? And were Abraxane and Nilotinib already launched in Q1 or in July?

We have launched partially in Q1. The Q1 does not reflect the full momentum of the launch for Nilo and Pacli. Revlimid will be a critical phasing and might phase out where in the first 3 quarters there might be more Revlimid and quarter 4 it will peter off, although prices have already started correcting in the market.

Kunal Dhamesha · Macquarie

Our aspiration to achieve closer to $1 billion sales in U.S. in FY '27, do we still believe that's possible? And would $1 billion bake in Symbicort?

Yes, that's largely out of our pipeline opportunity. We believe that our pipeline should hopefully get us closer or surpass that, depending on the launch timing. It would bake in a lot of our respiratory launches, including Symbicort.

Kunal Dhamesha · Macquarie

On India business, excluding consumer, we are at roughly 3% growth and trade generics is strong, so branded generic has been muted. Within respi, shouldn't our portfolio be more chronic with less volatility versus IPM respi?

Ideally yes - on a full year basis we think respiratory and overall growth will be very strong. This quarter, the impact of seasons being different, rains in summer, the respiratory season didn't really take off. As the largest player in that category, it impacts us. We strategically aligned our team to further growth of triples combinations with several triple launches coming. From a full year perspective we are very confident.

Tushar Manudhane · Motilal Oswal Financial Services

On respiratory at industry level, growth has been slow for the last 12 to 15 months or past 2 years. Could you throw some light on that?

We are coming off a fairly significant respiratory quantum in the industry. There were adjustments to price made on some large inhalers in the last 12 to 15 months by government notifications and DPCO certifications, which impacted some of our brands as they adjusted to lower pricing. Volume growth is there but coming from categories where we've repositioned for more program growth. The slower growth may be a phenomenon of a year or 1.5 years, but we are quite bullish going forward.

Damayanti Kerai · HSBC

On respiratory launches in U.S., will Advair likely be a 1H or 2H launch? For Symbicort and other inhalation products, have you done dual filing for risk management?

Yes, we have done double filings for most of our products from a risk management perspective on the respiratory side. And generic Advair, the way we are looking at it, may be an H2 launch in this year.

Damayanti Kerai · HSBC

Now you have both 505(b)(2) as well as the generic version of Lanreotide. Where do you see more room to gain market share?

The generic always has the maximum room because it's a completely substitutable product. It depends on the production mix between the 2 and your ability to supply it to the marketplace. In any product category, generics will always have the ability to gain more market share.

Surya Narayan Patra · PhillipCapital

On Albuterol in the U.S., is the meaningful sequential ramp-up because of competition factor or aggression from our side?

We've been on the path of this recovery for almost 12, 13 months or so. Our share had dropped about a year back, and after that we have consistently gained the market share. So yes, it's just maximizing the supplies that we have.

Neha Manpuria · Bank of America

On India growth, given low base from trade generic restructuring last year, shouldn't growth be better than industry? And will respi realignment impact growth for a couple of quarters or just this quarter?

Yes, the growth should have been higher. When we isolate the problem - we are strong on Gx, strong on CHL. But on prescription business, largely because respiratory and acute is almost 59%, 58% of total mix, and unfortunately this quarter they've both grown at 4%, 5% level. It was a slower quarter than what we thought, exacerbated because we were also restructuring and realigning teams. Seasonal triggers have kicked in and we are seeing the impact in our growth now.

Neha Manpuria · Bank of America

For the full year, can India business grow in line with the industry?

Yes, yes. At least for the next 3 quarters, we think that we can grow in line with the industry, for sure.

Bino Pathiparampil · Elara Capital

One Indian player has taken a significant stake in Adcock Ingram in South Africa. Does this change the market or competitive dynamics for you?

Adcock from what we understand already had a significant relationship with Natco. So I'm not sure that competitive dynamics will change significantly. Adcock has a large share of the OTC portfolio as much as it does on the branded side. If they get more pipeline from Natco, then yes, competitive dynamics would change. But the existing relationship also has significant support to the Adcock engine from Natco.

Ankush Mahajan · Sanctum Wealth

Next quarter we are launching one biosimilar in the U.S. What is the strategy for other biosimilars to launch in the U.S.? What is the timing for licensed biosimilars - 2 or 3?

We will probably in-license a few assets through partnerships in the near term and maybe launch our own biosimilar assets somewhere towards the '29, '30 time period. Right now we're launching one through partnership, and we will have a few partnerships through which we will launch in the near term. In the longer term it will be our own assets.

Tushar Manudhane · Motilal Oswal Financial Services Limited

On the biosimilar, this is not an interchangeable drug so we'll have to create prescriptions. What gives us right to win? How does in-licensing help for supply, and how much overall investment are we earmarking for biosimilar?

Our right to win is our oncology presence and team presence in the U.S. We sell into the institution channel - Lanreotide is a very large business and we sell 2 variants. The biosimilar goes through essentially the same channel. We have committed almost upwards of $100 million to a joint venture for our share of biosimilar development, and might increase our outlay in the next couple of years. In the short term we are launching biosimilars in partnership with others.

Sidharth Negandhi · Chanakya Wealth Creation

On trade generics - given possible impact on branded generics, what would be the quantum of growth in trade generics? How do you see this going forward in context of overall IPM growth?

Last year the pace of trade generics business was significantly lower because we had reacquired the distribution operation from our partner. So the superior growth rate is also a function of the base of the previous quarter plus ability to get back to significant growth. Going forward, trade generics will grow at IPM or about IPM. The range could be between 8% to 10%.

Sidharth Negandhi · Chanakya Wealth Creation

We've been seeing trade generics grow faster than IPM in the past. Given additional competition coming into trade generics, will our trade generics business grow at that rate?

A large share of IPM volumes are from products which are more acute and distributed inside the country. We believe trade generics will continue to grow at the same rate as IPM. Trade generics do not sell as many chronic therapies as on the branded side. While competition is great, it expands the market for trade generics. We have some very large brands within the trade generics segment and are quite hopeful of this segment going forward.

Shashank Krishnakumar · Emkay Global

On the domestic trade generic business, this quarter on relatively lower 1Q base last year, would it have grown at low single digits or a bit higher?

There was a lower base last year and on that there was a significant growth delivered this year. The seasonality on the anti-infective side also affects the trade generic side. Typically Q1 is not as strong a quarter for this business. Going forward we will see it growing in line with the market and hopefully beat the market as well.

Shashank Krishnakumar · Emkay Global

On the Indore facility, given it's been slightly more than 2 years, is it up for reinspection this year? How prepared are we?

We do expect a reinspection. General timelines are within the 2-year period. So we are expecting a reinspection any time from now till February. We are prepared for the inspection, and we're looking forward to it.

Kunal Dhamesha · Macquarie

On the INR120 crores other income, could you share how much is PLI? What would be sustainable PLI contribution for coming quarters/years?

Other income is below EBITDA. It has treasury income mainly, and exchange gains - those are the 2 big elements. Other operating income mainly has your PLI sitting out there, plus export incentives and small bit of scrap sale. PLI is a material component as part of other operating income. It is linked to the complex portfolio you sell in India or outside, but there is a cap on benefit per the scheme.

Kunal Dhamesha · Macquarie

Other expenses have come down by almost INR 80 crores excluding R&D on a sequential basis. Was there any one-off in Q4? Or is this a run rate to take going forward?

Run rate should continue. In Q4 there may have been some one-off that gets eliminated, but more or less every quarter will have some one-off. Overall this run rate should continue. Hopefully after Indore, your remediation costs should come down - that is one trend that should be noticeable.

Kunal Dhamesha · Macquarie

On India business, we added 5 brands in the INR100 crores plus category. How much time does it take on average to reach INR100 crores scale in India now? And can GLP-1 ramp up be faster?

It depends on the category, therapy area and our strength. Voltido Trio has started very strong. We launched empagliflozin brands in March when LOE happened and are already at fourth rank. Typically for a new brand it takes a while to reach INR 100 crores. On GLP-1 - last 3 months of IQVIA data show innovator brand has clocked around INR 50-plus crores, one of the fastest ramp-ups seen in India. Given the disruptive nature, ramp-up should be much faster.

Saion Mukherjee · Nomura Securities

On biosimilars, given filgrastim licensing, JV $100 million commitment, and own product in '29-'30, what are the key milestones over the next 2-3 years?

When we set up our decision to get into biosimilars 3 years back, most biosimilars had extensive Phase III requirements - that is beginning to change. So a biosimilar engine for a company like us will begin to mimic an investment return ratio more like a complex generics product. You could be spending $15 million, $20 million, $25 million per product minus Phase III. Interchangeability will make market access easier. We don't have any product out of our own engine which will come out before '29-'30 - by design. We will deploy capital towards in-licensing. The $100 million will be invested in the next 3 years, and we've already spent 20%, 30% of that. It is part of our R&D budget.

Krishnendu Saha · Quantum

Did I hear correctly that there was lack of capacity in albuterol so we couldn't take larger market share? Will you be putting up capacity?

Let me clarify - we are maximizing our capacity out there and able to supply all of it. If we build more capacity, we can increase further. From a market share point of view, at 19.5% maybe some more improvement, but that's where we can go to with the current capacity. This is our own capacity - we supply from India, and we have capacity in Fall River as well. This is the capacity we'll keep in the future also.

Prepared remarks (3 blocks)
As Cipla marks its 90th anniversary, we delivered a steady revenue of INR <strong>6,957 crore</strong>s with an EBITDA margin of 25.6%. This builds on a strong prior year-on-year quarter where we achieved our highest ever U.S. generics revenue, despite facing price erosion in one of our large products in the U.S. Our One India business delivered a growth of 6% year-on-year for the quarter, breaching the threshold of INR 3,000 crores for the first time ever in the opening quarter of the financial year, which is now 44% of our global revenue. In our branded prescription business, we have a higher concentration of respiratory and anti-infective therapies, which is almost 30% higher than the broader market; these therapies saw modest market growth of just 5% each as per IQVIA MAT June '25. This quarter we launched Voltido Trio Ciphaler, an innovative addition to differentiated triple therapy offerings. The chronic segment continues to dominate and now has 61.5% share of our total sales. Foracort maintained its leadership as the number 1 brand in the IPM. We've added 5 new brands to the INR100 crores club, taking our total to 29. Our trade generics business continues to deliver strong growth with 7 new launches this quarter. Our Consumer Health business continued its strong upward trajectory with Nicotex, Omnigel and Cipladine securing number 1 positions in their segments. In North America, we delivered a quarterly revenue of $226 million.
Albuterol ranked number 1 in the overall U.S. Albuterol MDI market with a <strong>19.5%</strong> market share. Lanreotide has already matched last year's average quarterly sales. We expanded our portfolio with 2 key launches, Nano Paclitaxel and Nilotinib. We also signed an agreement to launch Cipla's first biosimilar in the U.S. expected in quarter 2 FY '26. On our U.S. pipeline, we are now closer to commercializing generic Advair. We remain committed to launching 2 to 3 peptide assets this year and preparing for key respiratory launches later in the fiscal year, including generic Symbicort. Our China facility now is fully utilized. Our One Africa business recorded a growth of 11% year-on-year in U.S. dollar terms, with South Africa growing 6% in ZAR terms. In the EMEU business, we delivered a healthy 8% revenue growth in U.S. dollar terms. On the regulatory front, the U.S. FDA inspected our Medispray facility located at Kundaim, Goa in Q4 FY '24 and the inspection was classified as a VAI; the U.S. FDA also inspected our Sitec Labs analytical testing facility located in Navi Mumbai during this quarter, also classified as VAI.
- Quarterly revenue: INR <strong>6,957 crore</strong>s, growth of 4% Y-o-Y - One India: breached threshold of INR 3,000 crores for the first time in the opening quarter of any financial year - EBITDA margin (excluding other income): 25.6% for the quarter, broadly flat Y-o-Y - Reported gross margin (after material costs): 68.8%, an increase of 156 basis points Y-o-Y, attributable to favorable shift in product mix and strategic portfolio management - Total expenses: INR 3,009 crores, reflecting an 8% increase over last year, primarily due to annual employee increments and increased investment in R&D - R&D investments: INR 432 crores, accounting for 6.2% of revenue - Profit after tax: INR 1,298 crores, representing 18.7% of sales, a solid 10.2% Y-o-Y growth with an expansion of 106 basis points - ETR: 27%, same as Y-o-Y - Total debt (including lease liabilities) as on 30th June: INR 459 crores - Net cash equivalent balance: INR 10,379 crores - North America quarterly revenue: $226 million - One Africa: 11% Y-o-Y growth in USD terms; South Africa: 6% growth in ZAR terms; private market secondary growth of 5.6% (vs market 3.8%) - EMEU: 8% revenue growth in USD terms - FY '26 EBITDA margin guidance maintained at 23.5% to 24.5%
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