Thank you. Hello, a warm welcome to our Third Quarter FY 23 Earnings call. I am Abhishek from the Sun Pharma Investor Relations team. We hope you have received the Q3 financials and the press release that were sent out earlier in the day. These are also available on our website. We have with us Mr. Dilip Shanghvi, Managing Director, Mr. C.S. Muralidharan, CFO, Mr. Abhay Gandhi, CEO, North America, and Mr. Kirti Ganorkar, CEO, India Business. Today, the team will discuss financial performance for the quarter, business highlights, and respond to any questions that you may have. For ease of discussion, we will look at the consolidated financials. The call recording and the call transcript will also be put up on our website shortly. The discussion today might include certain forward-looking statements, these must be viewed in conjunction with the risk that the business faces.
You are requested to ask two questions in the initial round. If you have more questions, you are requested to rejoin the queue. I also request all of you to kindly send in your questions that may remain unanswered today. I will now hand over the call to Mr. Shanghvi.
Thank you, Abhishek. Welcome, and thank you for joining us for this earnings call after the announcement of financial results for the quarter FY 2023. Let me discuss some of the highlights. Consolidated sales for the quarter were at INR 111,001 million, recording a growth of about 13.1% year-on-year, driven by global specialty, emerging markets, and India. Our continued focus on top line growth, operational efficiencies, and business continuity is producing results. For Q3, our global specialty revenue was at INR 235 million, up 28.4% year-on-year. ILUMYA and WINLEVI were the key growth drivers for the quarter. In January 2023, we announced the launch of SEZABY in the U.S. for treatment of neonatal seizures. Specialty R&D accounted for approximately 26% of total R&D spend for the quarter.
Abhay will give you more details on the specialty business later. I have been talking to you about our intent to increase our specialty footprint, especially in our core therapy area of dermatology, ophthalmology, and onco-derma. One condition in dermatology that doctors find particularly difficult to treat is alopecia areata due to limited number of I mean, effective approved treatments available. With that background, let me now briefly touch on the recently announced Concert Pharma acquisition. On nineteenth January, Sun Pharma entered into definitive agreement to acquire Concert Pharmaceuticals Incorporated. This acquisitions adds a late-stage asset, deuruxolitinib, for treating alopecia areata to our global specialty portfolio. The transaction is expected to be completed in the first quarter of calendar 2023.
Our immediate priority would be to follow Concert's plan to submit a New Drug Application for the lead asset to the U.S. FDA in the first half of calendar 2023. You need to keep in mind that we will have to restrict ourselves in what was disclosed in the press release issued at the time of announcement, given that the transaction would require requisite regulatory approvals and the tender offer for the U.S.-listed company is expected to commence soon. In summary, we will not be able to guide to peak revenue estimates for the lead product. We will also not be able to guide projected R&D spend to bring this product to market. However, it's important to note that additional costs are expected to be incurred in R&D before the product gets commercialized.
We are excited to widen our specialty offering in dermatology and plan to launch the asset across U.S. and other global markets in near future. We will be very happy to bring this product for patients globally. I will now hand over the call to Murali for discussion of the third quarter financial performance.
Thank you, Mr. Shanghvi. Good evening, everyone, and welcome to all of you. Our Q3 financials are already with you. As usual, we will look at key consolidated financials. Gross sales for Q3 are at INR 111,001 million, up by about 13.1% over Q3 last year. Material cost as a percent of sales was 25.3%, lower than Q3 last year due to better product mix, including higher specialty sales. Staff cost stands at 18.4% of sales, while staff cost in percentage terms are lower over Q3 last year. The increase in absolute value is attributed towards merit increase, consolidation of the Alchemee acquisition and expansion of the sales force in India. Other expenditure stands at 30.6% of sales, higher than Q3 last year.
The increase in other expenditure is attributed towards higher selling and distribution expenses, consolidation of the Alchemee business and higher R&D. As indicated in our past earnings calls, the expenses have seen an increasing trend on account of normalization of business activities. On Halol, we have indicated earlier that Halol shipment to U.S. accounted for approximately 3% revenues before the site received import alert. Apart from the loss of revenues for approximately three weeks in Q3, there is an increase in expense because of the import alert. This is primarily on account of provision related inventories and some other items. EBITDA for Q3 was at INR 30,037 million, including other operating revenues, up by 15.2% over Q3 last year, with resulting EBITDA margins at 26.7%.
We reported strong margins despite normalization of expenses and the impact of sales force expansion in India. Reported net profit for Q3 was at INR 21,660 million, up 5.2% year-on-year compared to Q3 last year. Adjusted for one-off effects in both the periods, net profit growth was higher than the EBITDA growth for the quarter. Reported EPS for the quarter was at INR 9 per share. Let me now discuss the key movements versus Q2 FY 2023. Our consolidated gross sales were higher by about 2.7% Q-on-Q at INR 111,001 million. Material cost at 25.3% of sales and staff cost at 18.4% of sales are almost similar to Q2 levels. Other expenses at 30.6% of sales were higher compared to Q2 FY 2023.
Increase in other expenses Q-on-Q was driven by higher sales and distribution expenses and increase in R&D spend. EBITDA for Q3 stands at INR 30,037 million, up by about 1.6% compared to Q2, and EBITDA margin for Q3 was at 26.7% compared to 27% for Q2. Reported net profit for Q3 stands at INR 21,660 million. We will discuss the nine-month performance. For the nine-month period ended 31st December 2022, gross sales were at INR 325,533 million, a growth of 12.1% over the nine-month period last year. Excluding COVID product sales for the nine months last year, overall sales are up by about 13.6%.
Material cost for nine months was at 25.8% of sales, lower year-over-year, mainly driven by better product mix, including higher specialty sales. While staff cost as percentage of sales are similar to nine months last year, the increase in absolute value is on account of annual merit increase, consolidation of the Alchemee business and expansion of the field force in India. Other expenses were at 29.1% of sales, is higher than nine months last year on account of higher selling and distribution expenses and consolidation of the Alchemee business. EBITDA for the nine months was at INR 88,447 million, a growth of 9.8% over the nine months last year, with resulting EBITDA margin of 26.8%.
Net profit for nine months was at INR 64,891 million, up 6.6% over adjusted net profit of nine months last year. As of December 31st, 2022, net cash was $1.8 billion at consolidated level and about $621 million at ex-Taro level. Let me now briefly discuss Taro's performance. Taro posted Q3 FY23 sales of $139 million, flat over Q3 last year, and net profit of $7.3 million. For the nine months, sales were at $426 million, up by 2% over nine months last year. Net profit for nine months FY23 was $18.5 million, compared to $30.9 million for nine months FY22.
Taro's financials for Q3 FY 2023 and nine months FY 2023 included the consolidation of the Alchemee business. I will now hand over to Mr. Kirti Ganorkar, who will share the performance of our India business.
Thank you, Mr. Murali. Let me take you through the performance of our India business. For Q3, the sales of formulations in India were INR 33,919 million, up by 7.1% year-on-year. For these nine months, sales were at INR 102 390,000 million, up by 10.3% like-to-like basis, excluding COVID product sales of nine months last year.
India formulation sales accounted for about 31% of total consolidated sales. There were no COVID product sales in Q3 of FY 2023, and negligible COVID product sales in Q3 of FY 2022. We continue to witness good growth across multiple therapy areas in chronic and the subchronic segment for the quarter. Sun Pharma is ranked number one and holds 8.5% market share in the over INR 1,800 billion Indian pharmaceutical market as per AIOCD AWACS MAT December 2022 report. Corresponding market share for the previous period was 8.2%. As per SMSRC MAT October 2022 report, we are number one ranked by prescription with 12 different doctor categories for Q3 of FY 2023. For Q3, we have launched 25 new products in the Indian market.
The sales force expansion has helped us to declutter our portfolio, and we have been able to expand our prescriber base in key therapeutic categories. We are also increasing penetration in metros tier two and tier three town. Focus in near term will be to continue to improve the sales force productivity. I will now hand over the call to Abhay.
Thank you, Kirti. I will briefly discuss the performance highlights of our U.S. businesses. For Q3, our overall sales in the U.S. grew by about 6.3% over Q3 last year to $422 million. The main driver of growth was the specialty business driven by ILUMYA and WINLEVI. U.S. accounted for over 31% of consolidated sales for the quarter. Specialty sales have also grown compared to September 2022 quarter. We remain excited on growth opportunities in the current portfolio. Let me now update you on our U.S. generics business. The Sun X-Tero generics business has marginally declined on year-over-year basis due to stoppage of U.S. shipments from Halol in December 2022. Over the last year, this business has gained from a combination of new products, market share gains for existing products, and better supply chain management.
For quarter three, we launched two generic products in the US on a Taro basis. I will now hand the call back to Mr. Shanghvi.
Thank you, Abhay. I will briefly discuss the performance highlights of our other businesses as well as give you an update on our R&D initiatives. Our formulation sales in emerging markets were at $257 million for Q3, up by around 7.7% year-on-year. The underlying growth in constant currency value was at about 14%. Emerging markets accounted for about 19% of total sales for Q3. Formulation sales in rest of the world market, excluding U.S. and emerging markets, were $189 million in Q3, higher by about 4.8% over Q3 last year. The revenues of $189 million includes a milestone payment received of $12.5 million. Rest of the world market accounted for about 14% of consolidated Q3 revenue.
API sales for Q3 were INR 5,154 million, up by around 9.4% over Q3 last year. We continue to invest in building our R&D pipeline for both the global generics and specialty business. Consolidated investments towards R&D for Q3 FY23 stands at INR 6,702 million, 6% of sales. This compares to INR 5,471 million, 5.6% of sales for Q3 2022, and INR 5,710 million, 5.3% of sales in Q2 '23. Our current generic pipeline for the U.S. market includes 96 ANDAs and 13 NDAs awaiting approval with the FDA. Our specialty R&D pipeline includes four molecules undergoing clinical trial. We should be able to update the status of this trial in our next call.
The R&D investments have increased compared to Q2, and we expect a continued ramp up of the same. R&D investments are likely to increase both for our specialty and generic businesses. The board has declared an interim dividend of INR 7.5 per share for the year FY 2023 against INR 7 per share interim dividend for the previous year. With this, I would like to leave the floor open for questions. Thank you.
Thank you very much. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the desktop telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. Reminder to the participants, anyone who wishes to ask a question may press star and one. The first question is from the line of Naushad Chaudhary from Aditya Birla Sun Life AMC. Please go ahead.
Yeah, hi. Thanks for the opportunity and congrats on a decent set of number. Firstly, on Concert Pharmaceuticals, I understand, so I don't want any specific number. Directionally, if you can, you know, help us understand in terms of the cost structure and R&D spend, the intensity would be similar to calendar year 2022 in calendar year 2023, or should it directionally come down or go up? If you could, you know, give us the direction in terms of cost structure intensity?
No, I think it's difficult to give information in context of what you call limited information we have and also a need to kind of be cognizant of the restrictions. Conceptually, you need to keep in mind that they have announced that the phase III trial is complete, and they are in the process of filing the product, or they wish to file the product in the first half.
Secondly, on the other expenses, was there any one-off in this quarter, or was there any cost related to Concert acquisition which may not be there in the coming quarters, or was it a normal cost structure?
It was a normal cost structure. As said in the readout, it was on account of the normalization of the operations. There is no one-off or anything related to the transaction.
Last, just a clarification. If I look at our specialty business, the revenue share sequentially have moved up, meaningfully. But, if I look at the gross margin, which looks flat, can you help us understand this matter?
As far the COGS is concerned, while we agree that the speciality businesses have increased, it will help us to improve the margins. However, COGS is also a function of product and other geography mix. As a result of which, what we'll say is that the COGS, what is trending, is as per our overall expectations.
All right. Thank you so much, and all the best.
Yes. Thank you.
Thank you. The next question is from the line of Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.
The portfolio has been now increasing for the three quarters. Is it to do with the new-?
Thank you, Mr. Manudhane. Sir, I would request you to please repeat your question. There was some audio loss. Thank you.
Is it better?
Yes, sir.
Okay. This is with respect to the R&D cost on the specialty front. That has been increasing for the past 3 quarters now. Is it to do with the new indication for ILUMYA?
Yeah, I think we've guided that, we had challenges in terms of ramping up the clinical studies, because of the COVID and subsequently because of the, war in Russia as well as Ukraine. That had affected recruitment of new subjects. I think, I had explained that we will gradually find a way to, identify new sites and find a way to accelerate the recruitment.
That's interesting. Sir, just on your comment in terms of intent to increase the specialty footprint. If either in terms of the number of MRs or in terms of the absolute cost increase, if you can help us in the sub for FY 2024?
I mean, what I shared is that our increasing focus on growing the specialty business. I mean, that doesn't necessarily mean that we would be strengthening the field force or anything at this point of time.
Understood. Just secondly, on this India business where there has been a addition of a good sales force, there has been 25 launches , 30 launches on a quarterly basis for almost three, four quarters now. 3Q of FY23 seems to be subdued at 7% year-over-year. Any particular thing you would like to call out?
I think, the quarter three, was slightly below the market, that is 7.7%. If you look at our MAT, December growth, which is higher than the market. MAT like, market is growing at 7.7% and we are growing by 11.3%. In the quarter three, is what has happened is like, as you know, Estavel and Estamate, these were the two products we licensed from Merck, and they went off patent in the month for July. After that we have made this product affordable. These were the big brands where we have made the product attractive and make it affordable for the patients.
We have lost some top line, but at the same time we are maintaining our market share in terms of unit. That has impacted our growth in quarter three. As well as we had some challenges is one of the business unit in Gastro where the growth were not as per expectations. Other than that, all other therapy areas, either we are in line with market or growing better than the market.
Gastro challenge is being addressed now, so we can be back to growth path, in the coming quarters?
That's our continuous effort is wherever we see some of the areas not growing as per our expectations, we try and address some of these issues. They take time also. It's not the next quarter it will get addressed, but over a period of couple of quarters, I think they should come back to growth in line with market.
That's it. Just lastly, if I may ask you, this milestone receipt sits in ROW sales, right?
Yes.
Okay, sir. Thanks. Thanks a lot.
Thank you. The next question is from the line of Kunal Dhamecha from Macquarie. Please go ahead.
Good evening, thank you for taking my question. First just one clarification on other expenses. I think in your opening remarks you said that there was some kind of inventory provision related to products being not supplied from Halol, et cetera. Would you be able to quantify that?
While we have taken the requested provisions during the inventory and other items, on the same level, it's not very significant.
Okay. And there are no kind of failure to supply penalties or the remediation costs, et cetera, included in other expenses?
Whatever in terms of needs to be considered in the current quarter, has been considered relevant hits and then they are not significant enough.
Okay. Perfect. My first question basically is on Vindavy. I think, you know, this product has featured as a kind of growth driver for specialty sales for the first time. You know, is there any particular, you know, thing that has changed in the US, you know, which is kind of helping us grow faster in this product now? As far as, you know, we are concerned, whatever prescription data we follow, is generally showing quarter-on-quarter more or less kind of flat prescription data. Is there anything fundamentally changed there on WINLEVI?
The prescriptions that you see today are more profitable than in the past quarter because there has been an improvement in access. I mean, having said that, I mean, on various calls I have said that, improvement of access is an ongoing process. There is no finite time to completion of that. It will happen all through the course of the life cycle of the product. We have a long way to go in terms of improving that even further.
Okay. Is it fair to say we have like onboarded a big, you know, kind of, PBM right now, or in this quarter?
Sorry, can you repeat your question? Fair to say what?
We have onboarded a big, pharmacy benefits manager or an insurance company who is, you know, managing their PBM on their own.
Correct.
We still see there's a lot of scope.
True.
This kind of onboarding, does it help with the negotiating with other guys as well? The big guys basically.
I think we have to see. I mean, there are competitive dynamics even amongst the payers. Whether it helps us, time will tell. We certainly would try our level best to convince, the other payers also to cover the product.
Perfect. Thank you. Second question on Durubisovogene. Given there is another molecule with a very similar kind of chemical structure approved, will this be counted as a new chemical entity for us?
I mean, this definitely will be a new chemical entity.
It would come with the associated exclusivity, et cetera, if it gets approved?
That is correct.
Okay. Thank you. I'll join back with you.
Thank you. The next question is from the line of Neha Manpuria from Bank of America. Please go ahead.
Yeah. Thank you for taking my question. Two questions on the Concert acquisition. First, if I were to think about, you know, the lead asset here, you know, how do you think about reimbursement, given formulary coverage for the product? You know, there was since this could be seen as more, not fully, but more cosmetic use versus, you know, medical use. That's my first question. Second, you know, how does this product fit into our existing presence in derma with ILUMYA and the other products? Just trying to understand, you know, the additional investment that would be required to commercialize this product outside the R&D investment that you mentioned.
Abhay, would you respond?
I'll respond to the first part. I mean, from a science and medical perspective, AA or alopecia areata is clearly not a cosmetic condition. However, like what you said, a lot of payers, not doctors, but definitely payers may have that kind of a perception in mind. I think, the task for us even prior to launch will be to, you know, sell the concept and make payers understand that this is a medical condition and not a cosmetic condition. I think in that, I think the doctors that we are speaking to and the KOLs are pretty clear, they will also be, you know, helping put out that story.
Understood. you know, is the additional R&D that you mentioned prior to commercialization, you know, associated with us helping, you know, to help get better formulary coverage when we launch the product?
Data that we will generate from the R&D efforts will be used in various forms. The same data will be used with HCPs and in a modified form used with payers and PBMs and even the buyers of the product.
Mm-hmm.
Data is data. It is how you present it to relevant audiences that will make a difference in eventually how all elements of the market dynamics, interplay and have a positive impact on the product.
Understood. My second question, how does this product fit into the existing footprint that we have in derma from a sales force perspective, doctor coverage, perspective?
Like Mr. Shanghvi also said in his readout, I mean, we have covered in psoriasis, we have products in acne, actinic keratosis. This was one unmet need, so it enhances the basket of offering that we have for dermatologists and doctors who treat dermatology conditions. I think from an indication perspective, it is a clear fit into what we already do. There is a significant overlap between the HCPs that we meet.
Mm-hmm.
The HCPs who are likely to be treating alopecia areata.
Understood. Just one last clarification on the R&D spend. Is the R&D, additional R&D included in the guidance that we have mentioned in the past, of 7% - 8% of sales? Should we look at it as over and above that?
I think we are currently underperforming in terms of the, what you call, spend.
Yes, sir.
Even if this gets added, I think, we will get the cost only for a month or so.
No, no, sir. I mean for, from a guidance perspective for next year, since you mentioned additional R&D.
That guidance we will give next year.
Okay.
I think we will look at the way all the products in different stages of development, like what I also shared, we should be able to also share some clinical outcome progress with some of the other studies that are coming.
Understood.
That we will give that guidance.
Understood. Thank you so much, sir.
Thank you.
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. Is it possible for you to talk a bit more about Halol, situation in the sense that: A, for the 14 exempted products, would you be able to, you know, restore, you know, all the sales? B, would you be using the site for non-US markets? C, how many ANDAs have been filed from your pending approval, or any color around any high-value products? Are you looking to site switch?
I think, Abhay can give more information about the exempt product and what kind of sales we will be able to maintain. We will look at what you call the important products approved or in the process of getting approval for switching or filing from additional sites.
Okay.
Just need to add to what, Mr. Shanghvi said. I mean, a lot of business that we will be talking about retaining or losing will be product specific. The situation is still a little fluid, I would say. Attempt will be obviously to retain all of it, but I don't think all of it will be retained. Some of it, you can assume, will be lost to competition.
Okay. Very clear.
The attempt will be to minimize that.
Okay. Very clear. Would you be using this site for non-U.S. market, or you would first rather get it back in remediation?
No, I think we are in touch with the other regulatory agencies, but site is being used for supplies to other geographies.
Okay. Okay, great. Second question is on the specialty portfolio, and Abhay, you know, the prescription for WINLEVI had kind of dipped around, if I remember correctly, October, November, and they have been inching up, I think they're back to 8,000 a week. Before that, it used to be 9,000-10,000, they're still not back up. Just any thoughts on that? Second, also on ILUMYA, if I see the IMS dollar data for 3Q, which is October, November, December, it's just flat quarter-on-quarter versus, you know, our primary sales being up. Anything to read through, or it's just a bit of an aberration?
The first part to your question, I mean, prescriptions are moving up, not at the pace that we would like, but they are moving up. I think we had made some changes to our co-pay plan, and then we had improvement in the access. I'm pretty confident that, you know, the growth trajectory we will be able to maintain. And this is about your question on WINLEVI, of course. On ILUMYA, I mean, personally, I don't see a challenge because of the channel that we are strong in, that is the medical benefit channels. Not all of that sales that you see in the IMS will be completely reflected.
If I see, and of course, on the call, I cannot discuss, but if I see the sales till yesterday for the month of Jan, I, you know, feel pretty strong that, you know, the positive momentum will continue.
Okay, sir. Great. Thank you so much.
Thank you.
Thank you. The next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.
Hello. what I understood was these 14 exempt products currently are not getting sold.
Mr. Agarwal, please repeat your question. There was some audio loss.
Okay. Am I audible now?
Yes, sir.
Okay. No, just wanted to understand this import alert situation better. Currently, what I understand is 14 exempted products are not being sold, and, you know, some activities that would be required to, you know, get these products enter the U.S. shore. Is that understanding right, and what is the value of these 14 products?
Abhay, you would like to answer or?
No, whichever way.
I think you will have more current information, sir.
Batch by batch, the products that we have in India, we have started releasing to market after discussions with our quality team as well as external consultants involved. For the fresh product which we are getting from India, as you said, there is a process to be followed, which we will follow and try and fulfill the needs of the market. Again, product wise and category wise, we don't give out numbers, so I can't really give an answer to your question of the exact contribution of these products.
Of the 155, is it half of the products sales or is it less than half? Some direction will help. When you say batch by batch, it is the FDA... I mean, you are releasing batch by batch or they are accepting batch by batch? If there can be any clarity there.
We are releasing it batch by batch after thorough testing of the products.
Okay. They are accepting it?
Yeah.
Okay. Lovely.
I think you should have clarity that it's a decision by the Sun quality to release the batch. FDA doesn't accept anything.
Okay.
Everything that we do is open for future audit.
Okay. When you release it batch by batch, it can be sold in the U.S. market. Is that understanding?
Batch by batch release for the U.S. market.
Okay. Okay. Direction on the, you know, 14 exempted products, it could be less than half or around half of your $155 million sales?
Abhay mentioned, we are not giving any specific product related revenues or disclosure.
Okay.
Overall, I think we have given modeling. You have got it, that, the total impact on the overall company sales is not more than 3%. That should give you some direction.
Right. When you said that you have taken some provisions, is it adjusted with COGS or is it a line item with other expenses? How should we think about that? Going forward also, how is all the provisions taken yet?
It's lying in both in COGS and other expenses, and are not very significant as I shared earlier.
Not significant henceforth?
When I said whatever we have baked in in the current quarter in the COGS and other expense line, it's not very significant I shared.
Okay. most of it has been taken or is yet to be taken, sir?
We have baked in whatever is, we are fully aware of completely, we've recognized it.
Okay. Okay, lovely. Lastly, on ROW and EM sales. Dollar terms, I was looking at, you know, two-year CAGR and three-year CAGR. It remains 2%-3% kind of CAGR dollar terms. Is there any focus in terms of additional launches, or is it because of the high COVID base? Or how should we think about growth in ROW and EM?
No, I think the growth is significantly more than 2%-3%. I don't have three-year data in front of me, but if I understand the relative percentage that the emerging market has, other markets have on the overall company performance, it's not. It's actually gaining in terms of overall share. In spite of growth in other markets, it's growing faster.
I have data from Q3 2021 to Q3.
I think can you then take it up separately with Abhishek and rework the numbers?
We will do that. Thank you, sir.
Thank you.
Thank you. The next question is from the line of Shyam Srinivasan from Goldman Sachs. Please go ahead.
Good evening. Thank you for taking my question. Just looking at global specialty sales, QOQ, $200 million has gone to $223 million. I'm excluding the milestone. That's about $20 million odd. When I look at non-Taro US formulation, it's flat, right? $282 million, same to $283 million. Just want to understand growth of specialty US versus non-US. Looks like there's been a bigger contribution from non-US. I'm obviously making an assumption on non-Taro generics, but just wanted your thoughts.
I mean, we have the data. I think for a specific reason we are not sharing the detailed, this. I understand that it creates a challenge for you trying to estimate. Our own, general feedback is that I think the business is growing, both in U.S. as well as in other geographies.
Thank you for the input, just anything on ROW because intuitively it seems to have grown faster. Have we done better in any of the other markets? I think that's where the underlying question was.
You're asking for specialty business or ROW?
Yes. Just I'm doing only specialty. Only specialty, global specialty, non-U.S.
Specialty business in ROW is not very large.
Got it. Got it. Helpful. Just a second question.
What you must be mixing up is that the royalty income is included in the...
No, no. I excluded that, sir. I excluded the twelve and a half million.
Then, then-
INR 200 has gone to INR 220.
It is very small part of the overall business.
Got it. No, no problem.
The U.S. and Europe.
Got it. I meant non-US as even Europe. If there is something that's happening incrementally in Europe, either through Almirall or others, that is also something that that'll be useful to know.
No, I think Almirall is doing quite well with the product, and that is why they triggered the milestone. I don't see dramatic difference in the performance. You need to know that in Europe, what happens is that different countries, based on a different point of time when they get reimbursement, the sales pick up.
Got it, sir. Helpful. Just a second question on the Concert deal from a financing perspective. I think I missed the ex-Taro cash balance for the quarter or the December end. How will we be financing it? Just the next few steps, if you could highlight, what should we be looking out for?
We already given our in the press release in terms of the options we have in terms of financing this transaction. Beyond that, we will not be able to comment how we'll be funding this transaction at this point of time. The process has also been shared, which has been filed with Concert also, which is out in public in terms of what we are following the listed entity.
Got it. Thank you and all the best. Thank you.
Thank you. The next question is from the line of Sayantan Maji from Credit Suisse. Please go ahead.
Yeah, thanks for the opportunity. I believe in the initial readout, the year-on-year increase in specialty was driven by ILUMYA and WINLEVI. What would have led to, you know, quarter-on-quarter increase? Are ILUMYA and WINLEVI, is it mainly because of ILUMYA and WINLEVI, or has there been a benefit from seasonality and stocking up as well, because dermatology portfolio usually have a favorable seasonality in 3Q.
There was a lot of breakup in the audio, so I'm really not sure what the question is.
Let me repeat it. Is it better?
Please. Yeah, much better. Thank you.
I was saying that in the initial read-out, you mentioned that the year-over-year increase in specialty was mainly led by ILUMYA and WINLEVI. I just wanted to check, are these the two factors for quarter-over-quarter increase as well? Would seasonality and stocking up by, you know...
Are you... Sorry. I'm sorry again. Are you what? You said, "Are you," and then I couldn't get the next couple of-
Yeah. yeah, I was asking seasonality and stocking up benefit, were.
No.
Were the major contributors.
There is no real stocking up on these products.
Okay. Okay. My second question is on Concert acquisition. There is an ongoing litigation that is going on between Incyte and Concert. Would the outcome of this event be a material one in order to, you know, launch the product on time? Or is it something which is already taken care of?
Yeah. We are aware, we're not commenting on that at this point of time.
Okay, no problem. Thank you for answering the questions.
Thank you. The next question is from the line of Krish Mehta from Enam Holdings. Please go ahead.
Hi. Thank you for taking my questions. The first question I had was on Concert acquisition. The cash balance of Concert seems to be at $140 million. How will you be treating this cash balance? Will the cash balance in Concert be fungible for Sun Pharma going forward, or we'll be using this only for Concert?
We will be dealing with the opening balance sheet as per the purchase of accounting post transaction close.
Okay, that's helpful. On the generic pricing erosion for Taro, we just wanted to understand on, you know, given that the operating income has picked up this quarter versus the last quarter, do you kind of see this trend continuing for Taro? How do you see the generic pricing trend for, you know, the ex-Taro business in terms of new product launches and market share gains in existing products?
Taro has, I think in their release said that they continue to see pricing challenges. I think beyond that, for us to respond on this call would not be appropriate.
Okay. Thank you so much. Good luck.
Yeah. Thank you.
Thank you. The next question is from the line of Nithyanand R from DAM Capital. Please go ahead.
Hi. Thanks for taking my question. Sir, first on the on the Sezaby launch, if you can just provide us some sense of the opportunity, the way we're seeing this opportunity for the study going forward?
We believe it's a very good product in a very serious indication of neonatal seizures, where there was no approved product and only basic products were available. Therefore, I think we licensed it from SPARC. Just launched it literally last week, so too soon to say, but we are obviously very optimistic about the product.
Mr. Gandhi, Sir, this is the operator. Mr. Gandhi, the audio is not clear from your end.
Yeah, yeah. Okay. Nothing changed. Can you hear me better now?
Yes, sir.
I don't know how much you caught of what I said. I think we believe it's an important product. In neonatal seizures, which is a very serious indication, an approved product is something that gives comfort to the doctors in the institutions as well as to the caregivers of the patient. I think, we are very hopeful this will be a good product area of growth.
I mean, just following up on that, you know, the grandfather products which are unapproved products which are there, is there a timeline for the FDA to remove them from the market, or how does that process work?
There is some modeling which we did. It is not definitive of how it will be looked at by the FDA. For different products, it could be treated differently, and it is also a function of the FDA to be able to believe that there will not be any drug shortage and the new product will be able to take its place, demand of the market.
This is not a laid out procedure that, you know, once you get an approved product for, you know, in a you know, in a category...
There is no laid out procedure that, you know, within X number of months or weeks the existing products are asked to go out of market. There is no such established procedure. It's something that we will have to work with the FDA, convince them, and it's a process that we will have to go through.
Second, on this exclusivity period, how long exclusivity do we get on a molecule like this? Is this a regular commercial exclusivity will be how long for this kind of product?
I'm not 100% sure, but I think it is INR 7 million.
Thank you, Mr. Agrawal. May we request that you return to the question queue for follow-up questions. We'll take the next question from the line of Vivek Agrawal from Citigroup. Please go ahead.
Hi. Thank you for the opportunity. The question is related to recently acquired from deuruxolitinib.
Mr. Agarwal, please use the handset mode, sir. The audio is not clear from your line.
The question is related to duroxolotine. sir, can you also comment on the safety profile of the drug, how this is compared to some of the product?
No, I think, whatever is in the public domain based on which, I think it's a relatively safe, product with a, what I would call a benign kind of, side effect profile that was reported in the studies that are in public domain. The phase III studies I think are in line with or maybe in the line with that. I think it's a safe and very effective product. That's why I think I talked about this in a context of, best-in-class product.
Thank you. The current participant has left the question queue. We'll take the next question from the line of Damyanti Kerai from HSBC. Please go ahead.
Hi, thank you for the opportunity. My question is on Halol again. What kind of remediation cost you foresee for resolving the pending issues there? Also, how do you see your U.S. generic sales trending over next few quarters, ex, Halol? Do you think you have headroom to minimize impact of sales lost at Halol from other facilities?
What I think, we shared at the time of, sharing the information about Halol is that based on this, we expect the impact to be less than 3% and of the total sales, and, we are not changing or revising our guidance because of this.
Regarding the cost, yeah, regarding the remediation cost, which you might be spending for issues there.
I think we're not sharing specific information, but there will be a certain amount of consultants and remediation costs associated with the bringing the facility back in compliance. There may also be some new investments which may be required. That's part of the remediation process.
Okay. Any timeline like what you're targeting by when you can see resolution of issues? Because this plant has been under FDA scrutiny for some time now.
No, I agree with you that it has been under scrutiny and in a OAI status for a very long time. We need to find a way to resolve the issue, and that's what we are working for.
Okay. My second question is on Taro Financial. The SG&A associated there seems to be trending at around $50 million a quarter. How should we see this cost going ahead? I understand that this includes Alchemee, but if you can comment on SG&A number for Taro.
Taro has published the results. They've also given the press release. Being a public company, I don't think we'll be able to share more information than what they have shared.
Okay. my last question is, where do you book Almirall-related benefits in your financials?
Milestone income we said is coming on RWD.
This is milestone income, but in a regular quarter, where do you capture this number if there is no milestone? Say, like normal, contribution coming from Almirall.
A normal sales goes into the overall, whatever we sell to Almirall goes to revenues.
Okay. Okay. Thanks.
Thank you. The next question is from the line of Bino Pathiparampil from InCred Capital. Please go ahead.
Hi, good evening. Most questions answered. Just one question. Dilip bhai, like you shared the revenue contribution from Halol, would you be able to do that regarding the Mohali facility as well? Because there is still some FDA issues going on there.
I mean, I don't have the details with me, but, I mean, we don't either give out revenue from plants or from separate businesses. Halol we gave out because I think it's important for investors to be able to evaluate the impact.
Understood. Yeah. Just a question on Sezaby. Would you be able to define the market in terms of number of patients treated a year for this indication, et cetera, something like that?
Abhay, would you?
Yeah. I mean, I don't have the number in front of me, but yes, that number is available. If you can, you know, I mean, I will share it with Abhishek post this call, and maybe you can connect with him offline and get that.
Sure. That's great. Thank you very much.
Thank you. The next question is from the line of Harith Ahamed from Avendus Spark. Please go ahead.
Good evening. Thanks for the opportunity. On the Concert acquisition, will you be able to comment on the purchase price allocation, with the consideration of $570 odd million reflect largely as intangibles on our balance sheet or will there be a significant goodwill creation? The intangibles will be amortized over what period, if you can give some color?
we, as we explained in the opening remarks on 19th January, signed a definitive agreement. This transaction has to close, which we expect to close probably the first quarter of this calendar year. Once it's completed, we will do the full blown purchase discount. At that time, relevant things will be taken care.
Okay. From an accounting standpoint, these payouts associated with the CVRs, will there be a liability created on our balance sheet, for these potential payouts?
There are multiple options available to treat these type of contingent value rights, which we evaluate along with the consultants at time of finalizing the purchase price accounting.
Okay. One question on generic Revlimid. We've disclosed a settlement for that product. Any color that you could share on the timelines for launch? Will this be an FY 2024 launch for us or is it much later?
Abhay, I think we've given some guidance in the past.
We are on track for launch.
Yes, that's what we are saying. Yeah.
Okay. We are not confirming it's a FY 2024 product.
No. All we have said, is that, we are on track as per the settlement with the innovator to launch. There is no change to that, in this quarter. Yeah.
Correct.
That's what we have said. Okay.
Okay. That's all from my side.
I had lost audio for a few seconds.
Thank you. The next question is from the line of Surya Patra from PhillipCapital. Please go ahead.
Thank you for the opportunity, sir. Just, first question on the Concert again. So how critical is the long-term tolerability study for the success of the molecule, sir? That is one. Secondly, whether this is just a lead molecule that is what we are acquiring through this acquisition or there is a potential other platform or technology as well as the product opportunity that we are acquiring.
I think the key focus or interest for us was deuruxolitinib and its proximity to market and its ability to help the alopecia areata patient who are currently not having any approved, good approved product for treating that condition. However, the company also has licensed products to other companies and they have some products which are not even licensed, but they have intellectual property. I think, as we develop better sense and understanding, we will share if there is any significant additional opportunity that we are able to identify from the pipeline.
This is a cash-free, debt-free kind of acquisition, sir? Because just wanted to have more clarity about the cash number that what we are seeing in the acquisition.
It's a debt-free acquisition. Cash will follow along with the company.
Sure. Okay. My next question is on the cost side, sir. Basically, we are seeing a kind of some impact obviously on the other expenses front, and that could be because of multiple factor. I'm just trying to understand to what extent this is led by, let's say, Taro's underperformance. Because it is Alchemee acquisition post that obviously we are seeing some impact on the cost side. If you can share on that front.
We already in the readout said that the increase in other expenses is driven by the higher selling and distribution expense across various geographies, higher R&D spend, and also the consolidation of Alchemee business. Separately, we will not be able to give any number what's related to Alchemee business or other components which is lying in the other expenses.
Okay. Because if we just adjust the licensing income, then the cost structure even looks slightly deteriorated. That is why. This licensing income... sorry, this milestone income would be a kind of a pure cash component.
Right.
Adjusted for that cost structure looks slightly deteriorated. That is why.
License income is not, it's part of the revenue, right? Operating revenue, other operating revenue.
Okay. Okay. Just last 1 question, sir, relating to the R&D. Now considering the kind of nature of our activities, and the intent to expand our specialty portfolio. Let's say in next 2-year period, the R&D spend mix towards the specialty would be to what extent of the total R&D spend directionally?
I think we've shared with investors that our focus is on creating a significant additional engine of growth through specialty business. We have been diligently building that business. That business will require investment in new clinical studies, R&D. We will commit all of that whenever that becomes necessary. We don't give guidance beyond the next year. That's where I think I have the challenge. Directionally, I think we would be strengthening our ability to execute on various specialty related investments.
Sure, sir. Yeah. Thank you, sir.
Thank you.
Thank you. The next question is from the line of Ritwik Sheth from B&K Securities. Please go ahead.
Yeah. Hi. Good evening, sir. I just had one question on the India business. Would it be possible to give a split for the pricing led, volume led and new lead growth for this quarter and nine months?
No, I think actually the what you call syndicated research, AX as well as IQVIA give you that information.
Okay. Okay. Thank you, sir, and all the best.
Thank you.
Thank you. The next question is from the line of Niket from Motilal Oswal AMC. Please go ahead. Niket, your line is in talk mode. Please go ahead with your question. Niket, your line is in talk mode. Please go ahead with your question. As there is no response from the current participant, we'll move on to the next question from the line of Smith from RDA. Please go ahead.
Thank you for the opportunity. Why have we discontinued AND approval for generic Welchol?
What is that?
Generic Welchol, cariprazine.
cariprazine?
Yeah, right.
What is the question?
I mean, why have we discontinued the AND approval?
I don't know what ANDA approval for cariprazine. I s that a public domain information? I don't know. We don't give information related to future products.
No, because, it is, approved and then we discontinue it, so.
That must be business reasons.
It is a fairly large product in US, so is it still meaningful opportunity for us?
Honestly, I am also not aware. I need to check back and then come back.
Okay.
Since we are not aware, I think it's better that you speak to Abhishek and get information.
Okay, I will. Thank you. That's it from my side.
Thank you. The next question is from the line of Mayank Khanduja from Axis Mutual Fund. Please go ahead.
Hi. I have two questions. The first question is on the nature of other expenses. I think you have commented that selling and distribution costs have gone up in this quarter. Wanted to understand what has led to this increase in selling and distribution costs for the quarter, and is it a structural increase?
Selling and distribution expenses, I mentioned that increase across geographies. We also mentioned specifically the field force expansion is fully completed in the beginning of this fiscal for India. Obviously in the current year, you will see a full expenses related to SND for those new field force added. That's why overall you're seeing an increase in the higher SND spend.
This is something you are saying it's increased across, the, employee spend as well as SG&A?
Yeah.
I mean, if you could split that-
Of course, more related to new field force expansion is obviously the full year impact is there, plus also the related spend on the SND rate for those field force.
Okay, understood. The second question is on the Halol side. I mean, we continue to, you know, face trouble in this. My question is, Mr. Shanghvi, you know, what is the core reason for this repeated issue that Halol, I mean, most of it will of course will be retrospective, but, what have you done to, like, address it over the past few years?
I think, clearly, whatever that we thought we needed to do, we've done, but it was not adequate. We need to strengthen our ability to ensure that the expectation of the regulatory agency are met. We believe that we've now put in place an appropriate focus and structure so that we should be able to meet the expectation of the agencies. I think that at the same point of time, we need to also keep in mind that a large number of our other facilities supplying to the U.S. are in compliance, and we continue to, what you call, grow our business in the U.S., in spite of significant pricing pressure as well as, what you call, challenges in the marketplace.
I mean, we all understand Halol is one of the large, and old complex which has got like multiple disease production. Is it because of it being an old plant, or is it because of, you know, shortage of proper skill set, or is it because of evolving standards of FDA? Is it something which, I mean, the practices here, is it something that you would be having across your other sites as well, because of which we could, it could be a systematic issue which has to be addressed?
I think the company policy is that whatever changes we make in one plant, if it is applicable and related to other facility, it is automatically put in priority for implementation in that facility. Halol, rather than being an old plant, I think we've made huge consecutive investments, and it's become a very large and complex facility. We have to find a way to reduce the complexity.
Got it. Thank you.
Thank you. The next question is from the line of Sameer Baisiwala from Morgan Stanley. Please go ahead.
Hi. Thanks for the follow-up. Just quick question. You know, the products which are of a lot of interest, you know, is semaglutide and liraglutide. You know, it could be interesting market. Any thoughts you can share? I can see that Sun is among the four to six filers, you know, for this product. You think it can get competitive? You still think it's going to be attractive opportunity? Just your thoughts would be great, sir.
Semaglutide is far away, Sameer. I think liraglutide is relatively recent. My expectation is that by the time the patent expires and we can come to the market, a large part of the current, what you call, patients would have moved over to Ozempic. To that extent, we have to look at residual market at the time of patent expiry.
Okay. That's great, sir. It's very helpful. Just one more, if I can, on deuruxolitinib, and that is, you know, it's a JAK one and two inhibitor, and we have this, you know, Olumiant in the market. Is that pricing and other JAKs in the are those pricing serve as a good benchmark for our product? I know it's still some time, but any thoughts on that?
So my-
We have assumptions, but we have no firm decision taken of where the pricing could be. Sorry, Dilip, you were saying something?
No, I think the idea would be to develop a comprehensive understanding on the price at which we can fully benefit from the value of the product and also patients have ability to access a effective treatment option.
Okay. Thank you very much.
Thank you. The next question is from the line of Naushad Chaudhary from Aditya Birla Sun Life AMC. Please go ahead.
Thanks for the follow-up. Few quick clarifications, sir. Firstly, in the press release, we have mentioned that the adjusted for one-off, the PAT growth in this quarter was higher than EBITDA. Can you just help help me what was the one-off for last year, same quarter?
Last year, same quarter, we have disclosed there was interest on income tax refund, and there was one settled income. We disclosed that. That has been adjusted in the next quarter.
Okay. Okay. In terms of the net MR addition in nine-month this financial year, can you share that number as well?
Yes, that's in India market.
Yeah.
Net addition.
Yes, we have completed the MR addition, like 1,000 MR we have added in this financial year, so that part we have completed. Lastly, qualitatively on the especially.
Sorry, yeah. I missed it.
The line for the third participant has been disconnected.
You lost audio, I think.
We'll move on to the next question from the line of Kunal Dhamesha from Macquarie. Please go ahead.
Yeah, thank you for the follow-up. Those additional studies will be more like a bridging studies or kind of a full-fledged trial that we need to conduct, at least for the bigger geographies like Europe, or Japan?
My understanding is that Europe may not require a additional study because quite a few of the studies in the study were also in Europe. It may not require a separate study.
Okay.
Same, I'm talking more about Japan, China, and these countries where maybe what studies will be required, we have to get interact with the regulators and develop and understand.
Sure. Just on Mohali, you know, after it has been kind of, classified as OAI, has there been any communication with U.S. FDA, in terms of further CAPAs, et cetera, we would have submitted?
I think there is a structured process about updating FDA about of this, what you call response 483 and what we are doing. There is a certain periodicity of that we follow.
Thank you and all the best.
Thank you.
Thank you. The next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.
Yeah, thanks for the follow-up. Just trying to understand, you know, the Taro cash. I understand, you know, Taro has a separate company, but you are the promoter and Taro is not hosting any calls anymore. I mean, how do we think about the utilization of that cash? Can they use this cash for, you know, similar asset acquisitions like you did, you know, in the specialty side? Or, you know, it's been there for long and it's accumulating. So what are the thoughts as a promoter?
Idea would be to find a profitable end use of the surplus cash so that it can be put to use. We constantly evaluate opportunities both in Sun as well as in Taro. Taro also has a separate business development group, and they also constantly evaluate opportunities. Hopefully, I think with rationalization of valuation, we should be able to do something.
Just a request, if you could have at least an annual call for Taro, that would be very useful.
We would communicate that or share it with you.
Okay, sir. Thanks.
Thank you.
Thank you. Ladies and gentlemen, that was the last question for today. I now hand the conference over to Mr. Abhishek Sharma for closing comments.
Thanks, everyone, for joining in today. Kindly reach out to the IR team for any remaining questions that you may have. Good night, everyone.
Yeah. Thank you.