Ladies and gentlemen, good day and welcome to the Cipla Limited Q2 FY 2022 Earnings Conference Call hosted by Kotak Securities Limited. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone.
I would now like to hand the conference over to Mr. Kawaljeet Saluja from Kotak Securities Limited. Thank you, and over to you, sir.
Hey, thank you, Stanford. Good evening, everyone. On behalf of Kotak, I thank the Cipla management for giving us the opportunity to host their 2Q FY 2022 earnings call. From Cipla we have with us, Mr. Umang Vohra, Managing Director and Global CEO, Mr. Kedar Upadhye, Global CFO, and Mr. Naveen Bansal from the Investor Relations team. I now hand over the call to the management team for their opening remarks. Over to you, Naveen.
Thank you so much, Kawal. Good evening and a very warm welcome to Cipla's quarter two earnings call. I'm Naveen from the Investor Relations team at Cipla. Let me draw your attention to the fact that on this call our discussion will include certain forward-looking statements, which are predictions, projections or other estimates about future events. These estimates reflect management's current expectation of the future performance of the company.
Please note that these estimates involve several risks and uncertainties, including the impact of COVID-19, that could cause our actual results to differ materially from what is expressed or implied. Cipla does not undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. With that, I would like to request Kedar to take over, please.
Thank you, Naveen. Good evening to all of you. We appreciate you joining us today for the second quarter earnings call for the financial year 2022. Before I begin, I hope that all of you and your families are safe and well. These are also festive times ahead, and I always believe that pharma is an amazingly complex sector and you all keep doing amazingly good work, a lot of hard work during the course of the year. I'm always impressed by your commentary and your direct and indirect push to management teams to improve the performance.
I wish that, you know, you'll get to spend decent time with your family during these festival days ahead. Coming to the quarter, we are pleased to report historically the highest quarterly revenue with a 10% Y-o-Y growth.v Our continued rigor on cost and operating efficiency while continuing our focus on growth-linked investments have helped us deliver robust EBITDA margin ahead of 22% for the quarter. We expect these efficiencies to continue in the coming period as well.
The 10% growth was driven by sustained momentum in branded markets of India and South Africa and emerging markets. On a high base of FY 2021 last year, the growth in One India is impressive and led by sustained traction across core therapies, both in prescription and trade generics business, despite significant moderation in the COVID contribution. EBITDA percentage of 22% ahead is in line with our guidance and includes inventory provision deemed appropriate for the COVID inventory that we are carrying.
Our working capital levels reflect our commitment to ensure the continued serviceability of supply, given several headwinds in the sourcing environment. Our U.S. revenues continue to see desired traction led by albuterol and now with arformoterol in quarter two. We have also witnessed steady momentum in the select products, which positions the portfolio to better respond to price erosion seen in the rest of the portfolio. Our free cash generation and operating efficiencies continue to drive our strong net cash position.
Coming to the financial performance, we want to highlight certain specifics. At a company level, the contribution of COVID was little more than 5% for this quarter. Adjusted for the same revenue growth for the company is at a strong trajectory of more than 10% on a like-for-like base of last year. As alluded in Q1 call, while our emerging market businesses recovered during the quarter, select products in our European operations have seen some bit of competition.
Similarly, tender flows in SAGA was also partly impacted by some delays in the order confirmation from clients. For the quarter, overall income from operations stands at INR 5,520 crore. Gross margin after material cost were at 61.3% for the quarter. While the gross margin was in line on a year-on-year basis, the sequential decline of 100 basis points is attributable to change in mix on account of normalization in the COVID portfolio and normalization of the API profit share with some inventory provisions that I referred to earlier.
Total expense, which include employees' costs and other expenses, stood at INR 2,157 crore, increased by 3% on a sequential basis. Employee costs for the quarter at INR 878 crore, it declined by 1% on a sequential basis. The other expenses, which include R&D, regulatory, quality, manufacturing, and sales promotion stood at INR 1,279 crores. They increased by 6%, largely driven by sales-linked variable expenses that we incur for various geographies. Total R&D investment for the quarter is about 274 crores or 5% of revenue.
All priority projects continue to be on track, and we expect R&D spends to respond to the clinical trial program going forward. Reported EBITDA was 1,226 crores or 22.2% of sales. The effective tax rate is 28.5%, and we reported profit after tax of 711 crores or 12.9% of sales. As of September 30, our long-term debt stands at ZAR 720 million. These are for operating requirements at South Africa.
During the quarter, we have prepaid the outstanding $137.5 million in InvaGen acquisition debt. With that, we have completely repaid all the loans for the U.S. acquisition. We have working capital loans of $74 million, ZAR 337 million, and AUD 5 million, which act as natural hedges towards our receivables. Driven by our relentless focus on cash generation and rigor on cost discipline during the quarter, we continue to be a net cash positive company.
Outstanding derivatives as a hedge for receivables as of September 30 are $155 million, ZAR 666 million, AUD 17 million, GBP 7 million, and EUR 6 million. Further, outstanding derivatives as hedges for payables as of September 30 are $11 million and EUR 1 million. We have also hedged a certain portion of our forecasted export revenues. Outstanding cash flow hedges as on 30 September are $280 million, ZAR 460 million, and AUD 9 million.
As you are aware, we had announced a scheme of demerger for our consumer health business and the India-based assets of the US business. We continue to believe that the scheme will simplify the structure, maximize efficiencies, and it has the potential to unlock value for all the stakeholders of the company.
We did an extensive assessment, and we understand that certain changes in the regulatory environment have made it feasible for the proposed transfer to be done quite efficiently through an alternate option and without the need for a scheme of arrangement. Accordingly, in the meeting today, the board has approved not to proceed ahead with the scheme and to examine transfer of these businesses by way of a more efficient option.
To close, we saw robust momentum across portfolio and geographies for first half. Growth levers in the subsequent quarters will include continued momentum across all regions, robust traction in our respiratory franchise in the U.S. and continued launches. Thirdly, pivoting businesses to sustain strong execution and driving expansion in operating profitability. I would now like to invite Umang to present the business and operating performance. Thank you.
Thank you, Kedar. I hope I am audible. I would like to wish all of you and your families good health, and I hope that everyone is safe and well. We continue to support the government efforts on ensuring availability of our COVID and other life-saving products. We are pleased to see the robust vaccination rates in the country and are happy to report that 89% of our colleagues across our operating geographies have taken at least one dose, and 59% have been fully vaccinated.
Coming to the strategic updates and operational performance, I am pleased to see continued delivery reflected in the robust performance for the quarter, driven by our branded markets of India and South Africa, supported by the unlocking of our respiratory franchise in the U.S. and traction in emerging markets despite geopolitical headwinds.
Our EBITDA margins for the quarter came in at 22.2% and continue to reflect our commitment to maintain the trajectory in FY 2022, despite significant moderation in the contribution of COVID versus the previous year.
In India, our One India strategy continues to see seamless execution. After delivering over $1 billion for our One India franchise in fiscal year 2021, we are tracking towards delivering $1 billion of revenue for our branded prescription business in India. On a high FY 2021 base, which included COVID products, the One India business grew 16% year-on-year, driven by robust traction in core therapies, despite expected normalization in the contribution from COVID product levels that we witnessed in the earlier days.
The revenue growth of 25% adjusted for core COVID products over quarter two of the previous year stands as testimony to the strong on-ground engagements with healthcare professionals and the strength of our large brands. We believe and are hopeful that this traction is likely to continue for the rest of the year as COVID-19 cases respond to the vaccination drive across the country.
The branded prescription business continues a strong performance during the quarter, driven by sustained volume growth across almost all our therapies. Our acute and respiratory nebulization businesses are also tracking well. As per IQVIA MAT September 2021, we continue to maintain ranks and market shares in our key therapy areas across respiratory, urology, anti-infective, and cardiac.
Over the last three years, we have forged strong partnerships with several MNC organizations for the strategic widening of our therapy base, with specialty offerings across cardiology, antidiabetic, and the oncology franchise. With an ambition to increase access to innovative medicines and enhance our chronic portfolio, we have also recently announced a partnership with Eli Lilly for the diabetes franchise.
This is of course subject to regulatory approvals. The trade generics business and consumer businesses have continued to deliver strong growth across flagship brands in respective businesses for that quarter.
Coming to our North America business, the U.S. generics core formulation sales for the quarter were a multi-quarter high of $142 million, in line with our expectations for the sequential run rate. Select products like diclofenac, cetirizine, escitalopram, and esomeprazole have witnessed steady momentum, which along with albuterol has helped in inching up the run rate and offsetting the price erosion in the rest of the portfolio.
As per IQVIA week ending eighth October 2021, we have clocked an 18% share in albuterol, and arformoterol, which we launched in the current quarter, has gathered about 39% share in the generic market. Cyclosporine ophthalmic emulsion, which was also launched during the quarter, is also tracking well in terms of the desired contracted share. We continue to maintain strong focus on the adequate supply of products and prepare for upcoming complex launches in the subsequent quarters.
On Advair, we have responded to the CRL to the U.S. FDA, and we will continue to share the updates on progress on the file as we hear more. We have been in continuous communication with the FDA for the Goa plant. We are awaiting the inspection schedule from the agency. Coming to SAGA, which includes South Africa, Sub-Saharan Africa and CGA, the overall SAGA region reported robust growth of 8% on a year-on-year basis in US dollar terms.
Our South Africa private business reported 20% growth over last year for the quarter in local currency terms. In USD terms, we continue to maintain market-leading growth of 8.7% versus a 5.4% private market growth as per IQVIA MAT, August 2021. The Sub-Saharan and CGA tender business, as you mentioned earlier, witnessed some delays in order confirmation from the clients. Our international markets reported 14% revenue growth year-on-year in US dollar terms.
Our emerging markets business rebounded after resuming Middle Eastern supply, which demonstrated strong performance in our direct-to-market businesses and from the contribution from COVID therapy products. We have witnessed incremental competition in Europe for a select category, leading to lower than anticipated performance.
We expect to offset some of these headwinds with traction and new launches in the subsequent quarters. During the quarter, we launched Bevacizumab biosimilar under partnership in Spain to strengthen our oncology portfolio.
Turning now to our outlook. We continue to strengthen our revenue streams with a differentiated portfolio, our product development capabilities and de-risking the supply chain across the markets. We are witnessing emerging demand patterns across our big businesses amid gradually recovering COVID environment. We're geared up to capitalize on the opportunities across the healthcare ecosystem to drive a robust portfolio momentum and strategic capital allocation.
Our near-term priorities include the continued execution on the demand levers in the chronic and acute therapies, improvement in manpower productivity across the branded and generic markets of India and South Africa. Active advancement on innovative consumer-centric products to accelerate the augmentation of our global consumer wellness franchise across both India and South Africa.
Continue to lead and grow respiratory categories like Albuterol and achieve a fair share in several other products that we are likely to launch. Monitor our key filings and accelerate our global lung leadership aspirations. Maximize the value opportunity in the U.S. complex generics with continued launch momentum and manufacturing facilities in a state of compliance and control. Continue to be highly vigilant on cost and cash management, operating margins and the return on capital employed.
With this, I would like to thank you for your attention. I wish you a very happy festival season, and for those of us in India, a very happy Diwali. Will request the moderator to open the session for Q&A.
Thank you, sir. Ladies and gentlemen, we will now begin the question and answer session. Anyone who wishes to ask a question may please press star then one on their touch-tone telephone. If you wish to remove yourself from the question queue, you may press star then two. Participants are requested to use handsets while asking a question. Anyone who wishes to ask questions, please press star then one. The first question is from the line of Prakash from Axis Capital. Please go ahead.
Yeah. Hi, good evening. Thanks for the opportunity. My first question is on the gross margins. I mean, you had a good growth across, India and, you know, South Africa, all the branded generic market, which has very good gross margins. In U.S., you have good market share across key products. Just trying to understand what has led to, you know, marginal dip in the gross margins. Has the increase in raw material led by China or other factors affecting us, and what is the outlook on the same?
Yeah. Prakash, there is some escalation on the Chinese-sourced items, which was there actually in first quarter as well, and some of that last year as well. I think incremental to the quarter is the provision that I referred to some of the COVID inventory we had to adjust based on the realizability. That's the only thing which is incremental to the quarter, Prakash.
How much is that? Sorry, I missed that.
About maybe you should take somewhere 80-100 basis points.
This is non-recurring, is what you're saying.
Yeah. I mean, every quarter we will have to sort of keep making an assessment. As of now, our assessment based on the existing balances that we're carrying, I think we have taken this provision in the books.
If we adjust for that, your gross margins were actually better than what we have seen in the past?
Correct.
Okay. Is there any outlook? How do you see it forward?
See, actually, if we go geography by geography, what we are driving is mix improvement. What we are driving is discipline on pricing and the best we could do to deal with some of the headwinds. I see a lot of headroom to improve, you know, for each business and at a company level.
Yeah. On a blended basis, it is looking not worse, is what I wanted to understand.
Yes.
Okay, perfect. My second question is on the U.S. U.S., while you alluded to, you know, increase in market share, plus you had couple of new launches where you have got very good market share. You see the Q -on- Q performance is pretty flattish. Any particular reason? Is there a base business, price erosion which has increased? Or is this not converted into realization and it would be converted into upcoming quarters? How should we think about it?
No, I think, first, here the issue is, that the price erosion is there on the rest of the portfolio. Our launch momentum is continuing to keep us ahead. I think we are one of the few companies which is recording a growth actually quarter-on-quarter sequentially. In the U.S., the growth should be higher when we have the bigger launches coming up.
Okay. Lastly, on Advair, is there any color which you can share or the progress?
Well, the agency, we know, is reviewing our files. We haven't specifically got any further communication from them.
Okay. It remains the fiscal 2023 approval and launch?
Yes, that is correct.
Okay. Thank you. I'll join back with you.
Thank you. The next question is from the line of Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.
Thanks for the opportunity. First, on the biosimilar front, we have good number of products now which are like kind of out licensed. If you could throw some light in terms of the overall investment which you would like to do in this segment in terms of manufacturing or product development?
I'm sorry. Could you repeat your question, please?
We have a decent number of products in terms of out licensing in the biosimilar space. We would like to understand, like, if there are any thoughts on the investment in this segment in terms of manufacturing and/or product development.
We have recently announced a JV for the regulated markets in the world and overall biosimilar development. That over a period of time, I think the costs will come in for that, and the objective is to take a few products to the market. The rest of the partnerships we have are more commercial partnerships on biosimilar, so they are already in our numbers.
Got you. In terms of like, the number or the amount of investment which we envisage over the next two years?
I don't think two years will be significant at all because some of the products we are after are going to be launching after four years or five years. I don't think the next two years we'll see that amount of investment, but it will gradually build up.
Got you, sir. Secondly, anything further on Goa side?
I'm sorry. I could not hear that very well.
Anything further on Goa side from the U.S. FDA discussion perspective?
Yeah. Umang, the question is, do we have an update on the Goa side?
Tushar, there is, I mean, nothing specific that we can give. We are in touch with the agency. Updates are frequently being sent. You know, we believe we are in a good shape for the agency to inspect the plant, and we are working with them for a re-inspection.
Okay, sir. Thank you. That's it. Thank you.
Thank you. The next question is from the line of Forum Parekh from Choice Institutional Broking. Please go ahead.
Sir, I just wanted to know, like, ex of albuterol, what would be the price erosion in our base portfolio in North America region?
It is not, Forum, it has not crossed the historical percentage. It's still. I mean, if I recollect, it used to be mid to high single digits. At an overall portfolio, I think it is still at that level. But product by product, the trends could vary. I think the price erosion in my view and my experience is always a product by product metric which plays out. While we may mathematically add up at an overall business level, that's not how it plays out in reality, as you can guess.
Okay.
I don't have any evidence to say that it is either, significantly reduced or significantly gone up compared to the historical, erosion percentage.
Okay. We can assume that the new launches in albuterol would continue to mitigate the price erosion going forward?
Yes, that's to mitigate and grow the base. Correct.
Okay. My second question is, sir, you had guided last quarter on call that EBITDA margin for FY 2022 would be above 22%. Do we still stand tall on that amidst the raw material price hike and China issues?
Our attempt will be to stay in line with what we spoke. There are headwinds, but there are tailwinds as well. As I said, I think improved pricing discipline, mix improvement, whatever we could do on addressing cost base, I think all these levers are available for us to stay within our guidance.
Okay. The last question, if I may squeeze in, please. Can you just guide on the CapEx side? What would be the incremental CapEx, if any?
The CapEx for the current year is in the magnitude of INR 800 crore-INR 900 crore or so, Forum. That includes investments for automating our manufacturing infrastructure. That includes couple of API projects, couple of new lines, capacity additions on reactors and maintenance CapEx.
Okay, thanks a lot, sir.
Some laboratory labs as well, lab setup cost as well.
All right. Thank you. Thank you a lot, sir.
Thank you. The next question is from the line of Anubhav Agarwal from Credit Suisse. Please go ahead.
Yeah, hi. Good evening to all. Umang, just a couple of questions. One is on the albuterol, I think 18% market share you mentioned, out of the generic suppliers only, right? Not of the total market, because IMS on the total shows 15%.
Yeah, yeah. We have mentioned, Anubhav, on the-
That is correct.
On the slide, we have mentioned 18.2 is between authorized generics and generic generics. In the total market, it's little less than 15%. You are right, Anubhav.
Just two observations there. One is that the brands are not losing market share, so they are still about all brands put together are still about 20% share for some time now. Second, Cipla's share has been its good share at 15%, but it's been around this 15% now almost for more than a quarter odd. Can you just comment on both the observations, when will Cipla start to show increasing share and why brands are not losing share?
Anubhav, I think this is a category where, frankly, all the shares that have been gathered by the two recent entrants are all from the brands only. I don't think that over the last one and a half years, the share that people have increased. I think brands have also lost share. There is one brand which does not have a generic alternative as yet. I think that brand, you know, may have also a strategy for holding on to their share in the marketplace. I think the brands will gradually begin to lose share.
I think the initial uptake in the shares has happened. I think that from a Cipla perspective, we have guided earlier also that we will see a gradual ramp up from here on shares. You know, Proventil used to be a 8%-7.8% category. It's now a 15%-16% category of the total market. We kind of see that this will continue to inch up, but gradually.
Sure, sure. That's helpful. The second question is on the margins expectation for next year. I'm not asking for guidance here, but if let's say Advair approval for us get delayed for whatever reason, right? Let's say, would you still think that this margin trajectory for the company 22%-23% can continue with Advair, without Advair?
Yes, I'd like to believe it. I mean, I think, the big, one there would not be so much whether the core business margin would continue because the core business stands today without Advair or anything else. It's also a combination of how our R&D spends begin to ramp up with respect to the new respiratory products that will go into clinical trials. I think there could be a, you know, there could be one odd % of R&D increase and some operating efficiencies balancing that out. By and large, we are committed to this trajectory.
Sure. Just last question on the COVID run rate. So we were doing about INR 100 crore a month COVID run rate in second quarter. By and large, right, would this run rate have come down to less than INR 50 crore per month now with much lesser COVID cases?
Yes. Broadly for India, yes, you are right. Our COVID run rate is probably down to that. I mean, it fluctuates month-on-month, so there's no real, you know, I can't say it's 50 per month or 60 per month because it's now become more localized as outbreaks happen. Yes, we are significantly lower versus last quarter, as well as actually versus the previous-year quarter on COVID.
Yeah. Sure.
Just some numbers, Anubhav, to model. I think especially India revenues have seen a 60% dip between quarter one to quarter two. If India was INR 150 per month, now quarter two is only INR 60 per month. We have to see how that stays in the balance of the quarter. That's the India COVID revenues for you.
Some COVID will always stay.
Yeah.
It's not going to disappear. Some part of the revenue base will stay.
Thank you guys. Very helpful.
Thank you. The next question is from the line of Kunal Dhamesha from Emkay Global. Please go ahead.
Thank you for the opportunity. The first one is on the other expenses. On a sequential basis, if I exclude the R&D, the other expenses has gone up by around INR 67 crore. But do you think that the 1,000 crore run rate which we have, you know, in this quarter, that is the run rate which will continue? Or do you see some more costs coming back as, you know, more things normalize? Because I think, you know, July was also slightly impacted by COVID. So any color would be helpful on that part.
No, I think on the cost with respect to the detailing work which is happening in India, some of the field activities in international markets and all other activities in the plants and depots, et cetera. I think current quarter builds most of that. This quarter sequentially has gone up, which I referred to in my section, is all because of the variable sales linked expenses. So we do have some sales commissions and fees like, you know, commercial fees. The increase is all on account of this variable sales linked expenses.
That part will be trending appropriately with the sales level. In my view, the fixed part, you know, which is outside this variable, I think mostly current quarter bakes in all those spends.
Okay. Sure. Since that part might not move a lot and our gross margins could improve, you know, by 100 basis, which is because of non-recurring inventory, you know. Isn't there a chance for a higher margin for the second half?
See, I mean, the overall margin will always be subject to several variables. We are committed to what we've spoken in the past on the margin trajectory. I mean, it becomes difficult to sort of give quarter by quarter guidance or estimate on the gross margin because it's subject to several variables in revenue, top line costs, our activities. We wouldn't want to get that. We would stay with what we have communicated. Obviously long term, as we said, there is a headroom to improve for each region and at overall company level.
Sure. In that case, you know, can you provide, let's say, some more detail on couple of, you know, headwind or tailwind which you see, you know, which could impact the profitability?
Yeah. The biggest tailwind is the launch momentum. The biggest headwind is the commodities inflation and the escalation in the Chinese source materials. Some of that we have already seen in the first quarter and second quarter as well. The launch momentum will be the biggest tailwind.
Sure. Thank you.
Thanks.
Thank you. The next question is from the line of Surya Narayan Patra from PhillipCapital. Please go ahead.
Yes, thank you. Thanks for this opportunity. Just on first question on the respiratory, sir. We have seen obviously your ICS is doing well in terms of achieving their lung diseases in the global market with domestic delivering strong over 20% kind of growth. Albuterol is also doing great. In the global market, is it the cost advantage that is helping you achieving your aspiration?
And in the domestic market or in the emerging market, this strong growth, is it also currently influenced by the COVID-related aspect and may subside subsequently? If you can clarify on these two aspects of your respiratory.
I think it's. Let me put it this way. The first is there is a technical barrier to respiratory. I think in most emerging markets we've crossed it. Recently in the launches in U.S. also we're showing that we can do that. Of course, each launch is different, each product is different. We have to stay humble because it's not a cart launch that, you know, you've launched an MDI, so you can launch a DPI. We are well aware of that and are working expeditiously to launch these.
One is the technical ability to get a product, to get a robust replicable product and to get it approved. Of course, in some of the emerging markets of the world, cost is also a very important part of the overall supply chain. I think we've been at both cost and capacity, and we have both of those.
COVID influence and whether it is also benefited in any way by COVID related aspect in the domestic as well as emerging market it might.
Yes. When the COVID wave was pretty high, whether it was in early part of quarter one and also to some extent in U.S. in, I would say 12 months back, we saw that the COVID wave was high. That time, of course, there was a little bit of benefit for the inhaler sale as well.
Okay. Sir, even second thing from the in-licensing business activity that we are currently in. There is observation that will take over gradually over last, let's say, 12 months to 18 months kind of time frame. There is a significant improvement that we have seen in all of our important markets, whether it is domestic market, Africa, emerging markets like Australia and all that.
There is a rising trend of in-licensed products and important ones. Is there a kind of a conscious decision to expand and monetize our reach or the marketing capability so that it will indirectly to some extent complement our margin expansion from the usage cost?
Look, I think the way we looked at the in-licensing strategy is with the product patent regime in India, you know, the ability for Cipla to offer itself as a partner to take therapies deep for some of our multinational partners, that is what we are, you know, that is the alliance we are signing up. I think this gives a good leeway because with the product patent regime in India you can't really launch products unless the patents are off.
Collaborating for in-licensing some of these products is a good model in our view. It also gives us a head start, you know, when the product goes generic.
Sure. Just last one question, sir. On the Revlimid, is there any kind of preparedness from our side, for the ultimate, launch, plan for Revlimid in the U.S.?
No, I mean, if the question is will we be prepared to launch when we are allowed to? Yes. The answer to that is yes. Just like any other launch, we will be prepared.
Okay, sure. Yeah. Thank you, sir.
Thank you. The next question is from the line of Nithya Balasubramanian from Bernstein Research. Please go ahead.
Thank you. Umang, can you update us on generic Abraxane? Where are you on the review with the FDA as well as some color you can give us on the respiratory pipeline?
Yeah, certainly. I think on Abraxane, you know, we are in communication with the agency and the review of our file and the questions that are being asked, I think we are responding to that. Your second question was on the respiratory pipeline. I think progress is pretty much on track with what we communicated last time. You know, we will be introducing more products into the clinical trial as well. Meanwhile, the review of the files that we've already filed are ongoing.
Umang, on generic Abraxane, do you have a target date from the FDA?
Well, the tag date is there, but it's consequential and inconsequential in some way. It's consequential for our own review, but there is a market formation date, which is probably-
Yeah.
more important in the case of that product.
I presume the Goa facility inspection is also a critical part.
Yes, that is correct. For Abraxane, the inspection has to happen because it is from the Goa facility.
Understood. On the respiratory pipeline, I think, Umang, you had mentioned the partnered asset which you had already filed and-
Yes.
two other assets which are supposed to be in clinical trials. Are you on track to I think the last time you mentioned you will be filing somewhere in FY 2023. Are you still tracking on those timelines and any updates you can give us on the partnered asset?
The partnered asset is already, I think the data has gone out and obviously the FDA is reviewing it. That is on, that is consistent. I think the other product also, you know, yes, we are on track to filing another product also at the end of FY 2023. You know, we will be initiating clinics on one very shortly.
Understood. My second question was on if you could help us understand the rationale behind CHL demerger, because your One India strategy was supposed to enable you to leverage synergies across your branded trade generics and consumer products, and this seems to be not in line with that strategy. If you can help us understand your thought process there.
Yeah, certainly. I think it's the CHL strategy for the One India policy is to look at products and where they create maximum amount of value, both for the company as well as for the stakeholders of the company. I think if you look at the CHL platform, it's a great platform where we build tremendous capability in being able to brand products. It's all one entity.
There's one Cipla, and we figure out which part of the business is best placed to take a particular portfolio and products that lend themselves to consumerization have the ability, you know, to go down a certain route. I think the aggregation of a branded business in one entity gives tremendous options to shareholders and stakeholders at a later date, both from the placement and the marketing of the product in the current term as well as from, you know, the ability to look at a branded business in total at a later time.
That we get. My question is, if that is the case, then why the demerger and how does it help you?
Well, the demerger helps because you're putting all your branded and consumerized assets into one entity. Right now all these entities are subsidiaries of Cipla. The One India strategy happens irrespective of which subsidiaries it may lie in. For example, some of our brands that we sell in the prescription business may be lying with another subsidiary of the company, but that doesn't mean that they don't belong to the One India business.
It's just a placement of assets here, and I think at a future date, there will be options available on how we could structure a branded business to continue to further the progress of some of these brands.
Got it. Thank you so much and all the best.
Thank you.
Thank you. The next question is from the line of Nitin Agarwal from DAM Capital Advisors. Please go ahead.
Hi. Thanks for taking my question. Two questions. One is on albuterol. You know, in recent times, have you seen price-based activity increasing? I mean, pricing-based competition, you know, that being a bigger strategy for newer companies coming in and leading to heightened pricing competition erosion in the overall space versus what you've seen in the initial days?
Well, there have been more entrants, certainly. I mean, from the time we came in, there's also been another competitor. I think we've seen normal price erosion on albuterol, not something which is destabilizing the market, if that's your question.
No, what I really meant is, so is it leading to a situation where, say a pricing depression versus a volume increase sort of letting itself out in terms of our ability to get incremental absolute, you know, dollar increases on our contribution margin sort of?
Yeah, actually, you know where we are, we are very happy with how the overall value monetization for us has happened in this space. And as I mentioned earlier, we are okay with. We've been mentioning this over the past two or three analyst calls, that we are okay with, you know, a gradual increase in share from here, as against upticks in share, where we pick up 5.5%, 7.7% chunks of market share. I don't think that's where we want to go. We are okay with a gradual ramp up from here.
We are conscious of the amount of effort that goes into managing and maintaining a supply chain. As well as, you know, we are conscious of how best we are served with the share value dynamics.
Thank you. Secondly, on we look through the U.S. business, you know, look through the next 26 quarters, barring I'm aware of, you know, where how do you see the complex or meaningful $10 million-$20 million launches in the portfolio? How should we look at that from a timing perspective?
You know, look, we have those dates which are there. Realistically, I mean, if I was to probably hedge a little on the side of comfort, I think starting quarter three, we should have a fair number of, you know, high value launches coming in for the U.S. business. I think it's really the next two or three quarters where, you know, we will have launches. I think I'm also quite confident that the next two, three quarters will result in some in some potential meaningful launch or launches.
I think the bulk of the work will really happen from quarter three of next year.
As in second half next year onwards.
Yeah, second half next year, I think the launch trajectory is very well shaped up, and I think in the interim also we will have launches. Really the big momentum will come at that time.
The last one. On the India market, I think this quarter was a slightly unusual quarter, finally in the sense of the very high, acute, you know, driven sales which came through from India. I mean, as we head into the winter season, which is typically a lower acute, I mean, lower quarter from acute perspective.
How should we look at our India business, in the second half in sort of going forward, given the fact that you've got a pretty substantial base over the last three, four quarters courtesy COVID, courtesy, you know, very high infection, driven sales in this quarter?
Yeah. I think we had two impacts versus the previous year. The previous year had a significantly larger COVID base, and it had very little anti-infective base. And because there were hardly any viral infections and other infections going around when, you know, when the COVID outbreak was there in the previous year. This year we've seen almost a, you know, significant reduction in the COVID and, you know, an increase in anti-infective. I think the winter season typically for Cipla is when the respiratory sales begin to peak.
But you know, it's. If your question is whether I can give you a certainty in terms of what or how each of these will play out, I think they constantly change. Every 15, 20 days, we are seeing different market shifts and patterns. I think we are hoping to see a relatively strong respiratory season this time in quarter three. I think over a period of time, the India growth will begin to moderate back to its historical average of 10%-12% in the industry growth. Of course, we will try to be higher than that.
Thank you. Best regards.
Thank you.
Thank you. The next question is from the line of Charulata Gaidhani from Dalal & Broacha Stock Broking . Please go ahead.
Yeah, my question pertains to the antiretrovirals. Do you expect a degrowth now onwards?
No, I think we should be able to hold on to the current base. For the quarter we explained there was some bit of a delay in order confirmation from some of the tender-based agencies. We don't expect significant decrease from here. We should be able to hold on to the current base.
Okay. That is for SAGA.
Yeah, yeah. I was referring to CGA, which includes ARVs largely.
Okay. What about ARVs in India?
See, ARVs in India, in fact is doing well, and we don't carve that out separately. There we have one, you know, couple of high value tenders and, that's going fine.
Okay. Can you give the value for consumer health and trade generics in the quarter?
We can. We'll take it offline, Charulata. We don't necessarily mark that separately, but we could give you indicative numbers. From the investor deck, you have seen the kind of brands which are there in the consumer health business. We have spoken about Omnigel growth. We have spoken about Cipcal. Omnigel has grown by 41% in the first half. Cipcal grew at 16%. Cofsils grew at 58%. Nicotex, which is the flagship brand, grew at 13%.
There are a lot of emerging consumer brands in India now. We have Prolyte ORS. That in fact grew at 110%. I'm giving you first half YOY growth, Charulata. Clocip grew at 59%, Cipladine grew at 52%, Maxirich grew at 44%. There are brands in South Africa also. All of this is seeing very healthy traction.
Yeah. Okay, fine. Yeah. Thank you.
Thanks.
Thank you. The next question is from the line of Sameer Baisiwala from Morgan Stanley. Please go ahead.
Hi. Thank you, and good evening, everyone. Just taking the previous Nitin's question. When you're referring to a strong second half next fiscal, you have in mind Revlimid, Abraxane, and Advair in mind?
Yes. I mean, those would be our pipeline products, Sameer. Yes, I have that in mind.
These are sort of, you know, looking at their progress or settlements, that's regulatory progress or settlements, et cetera, they are heading towards that second half next fiscal sort of time zone?
That is correct, yes.
Okay, great. Just on biosimilars, your JV with Kemwell, if you can just share, you know, what would be Kemwell's role. Is it only product development, or would they also be doing commercial scale manufacturing? Second is it limited to respiratory biosimilars? If so, then, you know, onco and immuno biosimilars?
Yeah. I think Kemwell is very strong in manufacturing and analytical capabilities related to manufacturing. They are our chosen obviously partner and that their role is basically doing this. Of course, we do the commercialization and the two of us do development together. Right now where we are is we're trying to set this up. Obviously, it's a new JV and it's, you know, we have to. The first thing that we need to put in place is a team, which is the work in progress.
On the product selection, yes, I think there could be a combination of respiratory and oncology, but each product will have its own merit of being chosen with the perspective of trying to be among the first to enter the market.
Okay, it's not only respiratory, but that's what I think our PR says.
No, it's. It's largely gonna be more structured around respiratory. If we come across an exciting product on the oncology immuno space, we will pick it up.
It's through the JV only, yeah?
That is correct.
Okay. Got it. What's the current contribution from biosims in your overall sales?
Across our markets, I don't have that number readily available. Maybe Kedar can send it later.
We can come back, yeah.
I mean, it would be less than 5% sort of a number or.
Yeah, yeah. That's true.
Okay. Okay, great. Just on India business, can I just ask, did you say that it's 5% contribution from COVID to your overall India sales?
No, no, that's total at a company level. The India COVID sales in, you know, from quarter one to quarter two have got moderated by 60%.
Okay.
Yeah. What we mentioned, the overall percentage is at a company level. There is some international revenues also which we have shipped this quarter.
Okay. Very clear. Okay. Just on the on-the-field, on-the-ground activity in India, is everything normalized, medical reps, or doctor calling, et cetera? Is it back to life sort of pre-COVID or is it any different?
It is back to life. Everything may not be offline. I think some of the training, some of the cycle meetings, some of the doctor interactions, in terms of number of activities, I think the attempt is to go back to what we were, but I think the mode of that is not exactly in line with pre-COVID mode. Some of that may be offline, some of that may be online. Yes, our people are on the ground. The attempt is to meet identified set of doctors per day. I think it's a hybrid model, more offline than online, if you compare to last year.
Okay. I mean, where do you think this is going to sort of, you know, mature or stabilize, between virtual doctor calls for and, you know, physical meet? Is it like 80/20, or any, anything in your mind?
Somewhere there, Sameer. Our feedback suggests that both the pharma companies and the channel partners and the customers, doctors are sort of adjusting to this hybrid modality. Whether it's 80/20, 90/10, I think time will tell. But in terms of the detailing activity, most of that is back, except as I mentioned, you know, the cycle meetings, et cetera, may not be 100% there. Conferences are not happening. International travel is much smaller compared to what it was, but everything else is largely started.
Okay, great. Thanks. That's it from my side. Happy Diwali in advance. Thank you.
Thanks.
Thank you. The next question is from the line of Anubhav Agarwal from Credit Suisse. Please go ahead.
Yeah. Thanks for follow-up question. Umang, couple of question. One is on Abraxane. The comments that you mentioned, is it that we have to do any data on that, redo the data or is it just some questions which you need to respond and you can still launch by September, timing which you have the segment?
No, I think we have to respond to some questions as well. Obviously, you know, some of those questions mean we have to redo some of the data, et cetera, to respond to it, which I think we are doing on that.
The major data that you'll have to do that there is a risk that you may not be able to come by September twenty-third?
No. Look, I don't know whether September, we're confirming a September date or not. I just know that most of these launches will happen starting quarter two, quarter three. Because the product is also, I mean, the settlement terms are confidential for each party. I can't confirm a September date. I can just say that, yes, we are on track and most of these launches will happen in the second half of next year.
Okay. Sure. Second, Umang, this is a repeated investor question which, for some reason keeps coming every quarter. Would you like to reassure investors again that you're continuing with the firm?
Based on what we've heard, I should have already left and I've been sitting somewhere else. No, my confirmation is that I'm very much here. I am actually in the role. I've just signed a new contract, so very much here.
Thank you very much, Umang. Yeah. Wish to keep talking to you for years now. Thank you.
Thank you.
Thank you. Ladies and gentlemen, that was the last question, and I hand the conference over to the management for closing comments.
No, thank you everyone for joining us on the call today. In case you have any follow-on questions, do write to us on investorrelations@cipla.com or you can reach out to either myself or Ankit from the investor relations team. Stay safe. Have a good night ahead. Thank you so much for joining us.
Thank you very much. Ladies and gentlemen, on behalf of Kotak Securities, that concludes this conference. We thank you all for joining us, and you may now disconnect your lines.