Good morning to everyone. On behalf of Nirmal Bang Institutional Equities, I welcome you all to this session with Indoco Remedies as a part of our investor conference. At the outset, I would like to thank the management of Indoco Remedies for giving us an opportunity to host them at our conference. Among the senior management of Indoco Remedies, today we have with us Miss Aditi Panandikar, Managing Director; Mr. Sundeep Bambolkar, Joint Managing Director; and Mr. Pramod Ghorpade, CFO. I would request the management to commence the session with some opening remarks on the business environment as it stands today. Further to which, we will open the floor to the investor for Q&A sessions. Thanks. Over to you, ma'am.
Good morning, everybody. I really can't make out how many people are online, but all the same, nice to interact with all of you. Coming to Indoco, as you know, three quarters are behind us. We recently had a call after our third quarter earnings. Most of you are aware of where we are. I cannot judge who is at what level for understanding about the company or where I should start, but very broadly, therefore, I'll give a brief background. At Indoco, for the nine months completed, we have done a top line of INR 1,200+ crore. The company has about 60% revenue coming from India business, 55%-60%, and the rest coming from international and API.
API is a very small contribution, considering it's a division which was created to support international formulations. Right? In India, we have several marketing divisions. Two divisions, Indoco, that is pharma and Spade, focused entirely on acute. We have Spera for gynecology, Excel for Ophthalmics, and the two dental divisions, Warren Ace and NxGen. In addition to that, we have a division for Chronic, that is Synergy. Broadly, we have 40% coming from pure acute, another 50% coming from Sub-chronic, and 10% from Chronic. In Sub-chronic, we typically classify those molecules and therapies which are other than cardio-diabetic, but still a prescription runs for two to three months at least.
For India business, we have three brands in the top 300 for the industry, Cyclopam, Febrex Plus, and ATM. Cyclopam is an age-old legacy product, but continues for the year. This year, for example, on YTD basis, is growing by 20%. Febrex Plus has had a challenging year, given the respiratory portfolio's ups and downs due to COVID base. As regards prescriptions go, it is on a firm footing. ATM is an azithromycin brand which did excellently well last year, post-COVID and during COVID time also. Of course, it has not done as well as last year, on prescription fronts and market share, it is still ranked number three and doing well. The dental divisions hardly got impacted for COVID and continue to perform very well.
Stomatological as a space, if I'm not mistaken, we are growing at double digit higher double digits this year also. That is roughly about India business. About a year ago, a year and a half ago, we made some structural changes in India, adding a CMO function in order to overcome an inherent weakness of the company, which was launching new products and making them a success. Happy to share, in the last 15, 16 months since we created this kind of a change, we have already launched three new launches. A fourth one is underway just now. The first launch product, Moxa, is a leader in its own market.
It was the seventh brand of Ozenoxacin to be launched, but it became market leader within three months of launch and continues to hold that position today also. The second launch was a product called Dropizin, which is a peripherally acting cough syrup for dry cough, so it has less sedation. It is also doing very well. As per AWACS, in the 15th month of launch, it has crossed a revenue of INR 1 crore already. The third product, Subitral, which is an itraconazole with a SUBA technology, microcrystalline, is also doing decently all right. As we speak, there's a new product again in the antifungal dermal space, which is under launch. I can talk about it a little later, not today, maybe in future meetings once the launch is completed. We work in a very competitive space.
That is briefly about the India operations. The dental divisions are doing Warren NxGen, which is more focused on creating prescriptions, has been doing exceedingly well this year. Warren Ace, which has more of the OTX kind of toothpaste portfolio, is finding its own feet with a new direct-to-consumer front, which is under creation right now. Through social media and other means, we are trying to reach our consumers directly. That will also help those products. Coming to the Chronic space, we combined two divisions, CND and Focus into one division, Synergy, in order to sort of be able to focus on those products which are in high growth therapies, and we are doing quite well on those products.
The division is focusing on five or six products and brands only, and is able to concentrate on that. One of the products they focus on is an age-old good brand of the company, Glychek. It's a gliclazide and gliclazide metformin combination. The second product they focus on is alogliptin, brand Aloja, which is the only alogliptin available in India that is with Indoco as a company. Broadly, that's about India business. There is some structuring, restructuring going to happen, but no real increase in manpower, frankly. We hope to be able to work with the same set of people as we go after increasing and creating better per head yield. Coming to the prescription business, we are ranked 20th among several players.
We do at least eight to nine positions better on the number of prescriptions we generate from doctors. We are hoping as the product mix and portfolio shifts, and we create prescriptions of much higher value, and for Sub-chronic and Chronic business giving more contribution, we shall be able to climb the ranks within the retail audit 10 ranks itself. Coming to international business, our international business is largely divided into three baskets. One is generic support to U.S.. The other is generic support and front end in for U.S. Generic contract manufacturing and front end for Europe and U.K. Emerging markets, where we sell our own branded business. I'd like to invite Mr. Sundeep to say a little bit about international business before we come back to some other things. Yeah, Sundeep.
Thank you, Aditi. Coming to the international business, I'll talk about the U.S. first, which is the most sought-after territory, geography. In U.S., we are specializing in Ophthalmics and injectables. Happy to report that our lacosamide injection, which was for three to four months at least the only generic available in the US market, is doing very well, continues to do very well. We have also launched Brinzolamide Ophthalmic Suspension and Brimonidine Timolol Ophthalmic Solution. These two products in the longer run will give us a very good traction. All of the three put together, in fact. We have an impressive lineup of Ophthalmics and injectables are doing well in the U.S.. As far as solid dosages are concerned, we are doing very well on Allopurinol. That's one single molecule.
We are backward integrated as far as the API is concerned, we have our own ANDA, which has been outlicensed to the front end, we continue to do exceedingly well there. There are some impressive products in the R&D pipeline, which names I cannot give out today. At least, three solids which we will be filing before December this year. We should be getting approval in about 12-14 months after that. Coming to Europe, we have already said that 17%-18% growth will not be a problem for Europe. We are very confident of doing that. Among the legacy products which are there, and not so profitable ones, we are doing good volumes there.
The new products, like Colchicine, Phenytoin Sodium capsules, these will give us much higher traction, and these will be launched in the new financial year. That's April 2023. All put together, things look very bright on the U.S. and Europe front. In fact, we do hold a certain competitive advantage in products like Colchicine because the regulatory agencies in future will not be allowing companies to make these products in the general area of manufacturing, and we have already set up and commercialized our new department in Goa Plant 1. Coming to the rest of the world markets comprising of mainly Africa, Asia, Latin America. There the margins are very good, and in particularly Africa, we are doing extremely well.
Africa comprises of French West Africa majorly, where we will be doing more than INR 60 crores this year. Kenya and Tanzania put together, where we shall be doing about INR 25-30 crores. Going ahead, the six countries where we are present right now in French West Africa, that's Ivory Coast, Mali, Burkina, Benin, Niger, and Cameroon. We have plans to expand them to Senegal, Chad, and few other countries. That expansion will happen in the coming financial year. As far as Latin America is concerned.
Sundeep, ROW business is branded, I think we should mentions that.
Yes, yes. We are promoting our own brands there, the same brands which we are promoting in India. It's absolutely branded business. In fact, in French West Africa, we have got about 125-130 medical representatives and country managers who are expat Indians, of Indian origin. Coming to Latin America, again, these are our own brands being promoted there by our front-end agents or partners. Although the business is small right now in the range of INR 35 crore-INR 40 crore, but the profitability there is very high. This I think is in short, the international formulation business. As and when questions come up, we shall answer the same. Thank you.
We also have a USFDA-approved testing lab, which is one of the small service businesses of the company, and it's called Indoco Analytical Solutions. Additional to which we have a CRO at Hyderabad, which we acquired from Nicholas Piramal some years ago, which is called AnaCipher. All in all, we have five USFDA-approved formulation facilities and two labs, one for biostudies and the other for testing. Indoco is therefore able to offer a end-to-end kind of service proposition for generics, and this is also to our great advantage when we do our own filings. I think we can now have questions unless, so we can specifically answer anything you have in mind.
Thank you, ma'am.
Yeah.
Participants, we shall now open the floor for questions- and- answers. To ask a question, please use Raise Hand function or come in directly by introducing yourself and your company. We have one question from Ajay, Unifi Capital. Please go ahead, sir.
Hi, Aditi ma'am. Hi, Sundeep sir. Nice to be connect, and thanks for the introduction once again. Always a great refresh when you know, ma'am talk about Indoco. Sundeep sir, my question, couple are there. One, sir, I would really request you to give some more granular perspective on what happened this quarter for the Brinzolamide. On call you mentioned that, you know, the USFDA had that, you know, change, you know, where they relate to medical devices for Ophthal instruments. Could you quantify when did this change really come about, how this resulted in the deferment of, you know, the profit share which got pushed out to the next quarter? Could you speak a little bit about that journey please sir? It'll be very useful if you could give some more insight into that.
Yeah, sure. This change of the CCS, you know, the plastic components happened I think about 6-8 months back. We have fallen in line and given all the information to the FDA. As regards in particular brinzolamide is concerned about the profit share getting pushed to the next quarter, we have made it very clear on the earnings call that there were some challenges in the supplies because of the CCS. We clarified that abundantly and those challenges have been totally overcome now. We have shipped goods once again and Teva is selling those goods in the market. In this current quarter we definitely expect profit share statement from Teva.
Got it, sir. That's adequately clear. What I understand from your previous conversations is that once Teva sells and, you know, the profit shares are recorded, it takes that typical three-month lag to, for you to receive those.
Correct.
That 6-8 months of delay of the CCS, you know, resulted in the, you know, shipments being pushed out to later than due.
Yeah. Yeah. Yeah.
So-
For few months, we had to stop selling the product because we didn't want problems in the market, you know, and recalling the batches and all that. We were very, very cautious on this front.
Mm.
Hence the delay in the profit share statement, because we had to stop selling the product.
Can I just come in here?
Yeah.
Contrary to our understanding of how solid orals are, Ophthalmics in particular are very complicated products to make. Beyond the formulation, which is what we develop, there is also a matter of the container closure system, CCS, what Sundeep has been talking about. Any change in which either material of construction, dimensions, or wearing off of the molds in which those container closure systems are made. Typically, anybody who uses container closure systems, even Cipla for that matter, who use it for their inhalants, are familiar with this. Where unlike in solid orals, where much of the product quality rests with your own tablet formulation, everything else is pretty standardized, very simple. Here I could put 30% weightage to the closure system as much as the product.
Eventually there is always the machine on which where every time the dimensions of the container closure system change or get modified, the machine then needs to be readjusted for that. Unless you get the right specs, you cannot make a good product. FDA also realized this, which is why they classified it from product to medical device. Which would mean people like us who used to constantly suffer whenever our container closure system suppliers would make small changes which came under the ambit of not significant enough to inform FDA, but significant enough to affect our product quality, frankly. FDA realized this and has now asked them to keep updating, sending files which are then, you know, known to us.
All this is, you know, it's a recent kind of a development in FDA and which is good for us actually. Long term, we should be able to suffer less on account of this. This remains a constant thing. In case of brinzolamide also, there was one such thing because of which, after the in-use aspect, we realized the system is weak. Since we work with MNC like Teva, every time we make any kind of changes, even if we are satisfied, we require the regulators to regulatory to clear it. It obviously takes more time. Like Sundeep said, end of the day we are very confident we are giving a product which is of the best standards.
No, got it. This is very helpful, Ma'am. Ma'am, could you just speak about the timing of when, you know, the FDA got more because, again, you know, Sundeep, sir, you mentioned in our October call that, you know, did it happen in these October, November months specifically?
No, I mean, you cannot... Sundeep, let me take this. It's not about specifically something that happens here or there.
Mm-hmm.
When FDA, when the container closure system guys have to modify something.
Mm-hmm.
In the interest of product quality, they start from making molds, giving you product. You then do trials on the line.
Okay.
When those trials are successful, you put them on stability. After stability is over, you are okay, then Teva checks it, then Teva's okay. All that happens, okay? It's as simple as that. Just coming to your supply, Sundeep, if I'm not mistaken, one volume strength of Teva only, of Brinzolamide has gone out, right?
Yeah.
Yeah.
Yeah. The larger volume, in the market, is just going, if I'm not mistaken.
Just going, yeah.
Yeah. That is what you have to understand. Yeah? Okay. Nothing else. I mean, there's nothing much to be bothered about. Yes, there has been a postponement, but these are things we really don't control. Except, we are increasing our understanding and knowledge of packaging as much as we do of the API. APIs are always sort of guided by the Drug Master Files.
Mm-hmm.
Which give us all information, which helps us analyze anything that the API manufacturer changes, how it will impact my product, kind of. Here, this part was not there. Now it is becoming, sort of controlled. Yeah.
Got it. This is very clear, ma'am. Thanks for that. Sundeep, sir, this would mean that the profit shares would come in FY 2024.
Yes, yes. Largely in 2024.
Okay.
First quarter.
Okay.
We'll certainly get some part in this quarter, but largely it will be April.
Okay. The dosage which is the higher volume, which you just comment, that will come in FY 2024. The earlier one will probably come in.
Yeah.
in the last quarter. Okay.
We started selling that also, but the larger part of the profit will come from April onwards.
Right. No, clearly, got this perspective. Right. Sir, the other thing is the Germany tender. We, if I recollect, if memory serves me right, that was ending in half year 2024, right? Calendar year 20 20, sorry, calendar year 20 23 right, the Germany order?
March. March 20-
It ends by 2022. March 2023.
March 2023.
Sir, you've got an extension of that for the next two years.
We won the tender once again for the next two years.
Got it. Got it. That business commences in, again, April only as the tender expires, or is there a timing mismatch?
Well, the old and the new ones will start overlapping each other from end of February, beginning of March.
Wonderful. Got it. Okay, this is very clear. Sir, you know, I think couple of calls ago, you know, the tender market for Africa, you know, for South Africa that you used to deal with, you had said that, you know, that pipeline is building again. Could you speak a little bit about that element as well?
Sure. There are 3-4 products which we have filed for the tenders in South Africa.
Mm-hmm.
South Africa is fully a tender-driven market.
Mm-hmm.
Those results will be known by beginning of March.
Okay.
Mid of March.
Okay.
Yeah.
Got it. We've already filed whether we qualify and win, we'll come to know. Got it.
Yes.
That will change. Okay, perfect. Ma'am, Aditi ma'am, could you call out what MR's productivity is today and, you know, what are we doing really still to drive that? I mean, whether it is-
Yeah. On sanctioned number of people on payroll, it's three and a half.
Okay.
Considering we have a lot of attrition at the first level of MR, factually it is around 3.9 today.
Okay. ma'am, where do you see this number from a perspective of...
It's going to only go up from here simply because the acute divisions, we are not adding too many people, right?
Mm-hmm.
Sales go up every year. This year was going to be always a very tough year to show growth because of the, you know, some months you would grow the others and some kind of therapies you will grow and others you would not. Per se, going ahead, I'm expecting for the next year for it to go close to 4.4 at least.
Okay. Got it, ma'am. Ma'am, you know, you mentioned that, you know, your new products as a percentage of sale, which, you know, a couple of years back was very low. It started to improve. Could you call out what's been the nine-month trajectory there and how you're seeing that as well?
Yeah. For example, Noxa is an INR 8 crore brand now.
Okay.
These are products which will just multiply in the initial few years. Okay. Roughly to tell you YTD basis, if I'm not mistaken, new launches are giving us close to 4.5% of our growth, which is higher than industry standard now simply because we are quite small otherwise. You know, we are planning a lot of new launches across several divisions.
Got it, ma'am.
Thanks a ton.
I'll wait for Aditya to.
Next question from Mr. Aditya Khemka, InCred Capital. Please go ahead, sir.
Yeah, hi. Thanks for the opportunity. Am I audible?
Yeah.
Yes, yes.
Okay, awesome. Sandeep, sir, on the comment on that Aditi also made on Brinzolamide having two sort of SKUs, one being the larger market size SKUs, the other being the smaller market size SKU. Sorry. When I check online, I just see one SKU, which is Brinzolamide, 0.1% ML pack. I'm, I just want to know what the second SKU is.
There are two volumes, SKUs, 10 ml and 15 ml.
10ml and 15 ml. Is 10 ml the bigger pack, bigger market, or is 15 mL the bigger market?
I think it's 10 ml.
10ml is the bigger. We are so far selling 15 ml.
Yeah.
We just started selling the 10 ml .
Yes, yes.
Oh, okay. Why the delay? I mean, I know container systems again being the challenge.
Same thing, Aditya.
Uh-huh.
Because as the volume increases, your nitrogen purging, the heights, the caps, the strength, the torque, everything changes.
Right.
have learned anything, working with, a giant like Teva is they have, subject matter experts for every little thing, including the torque on the machine, which is great learning for us. They have learned from their past issues, I guess. Every little thing gets standardized, validated, which is good. Okay? Yeah.
Right. Makes sense.
Like, Aditi said earlier, you know, although we are 10,000% sure, it has to go through their various subject matter experts and get validated, and then only they give us the green light.
Yeah, I understand. Can you divide the market, Sundeep sir? I think the brand, before we launched it was about $80 million brand, right? How is it split between the 10 and 15 ml?
Do you have the data here, Pramod? Sundeep, do you have it?
I can get back to you by afternoon.
It's okay. That's okay. That's not a problem. Second, question was on the U.S. sales just, you know, 3Q versus 2Q of FY 2023, we lost about INR 9-10 crores of sales, you know, from 2Q to 3Q. Just wondering because 3Q for the other pharma companies who have reported seems to have been a very strong quarter because the seasonal flu was very strong, antibiotics were being prescribed a lot more just in terms of volumes. Just trying to understand where did we slip, what resulted in the decline?
This is for India, you're asking, Abhilash? Sorry. For U.S.?
No, this is, U.S.
I'll just take that.
Yeah. We don't really have antibiotics for U.S., no, Sundeep, anyway.
Mm-hmm.
That's why I thought it's India. Yeah.
Yeah.
One of our suspension products of Dalacin, which was to get the approval in November end or December first week, has got delayed to April. Beyond April, in fact.
Mm-hmm. Mm-hmm.
Now, there was, of course, the, stocks were ready for dispatch. Besides that, there was a good milestone attached to it.
Right.
Both this put together would have been more than INR 10 crores.
That was a write-off that you took against the sales?
No, no, no.
No, no. I just.
We didn't dispatch. We didn't dispatch the goods at all because the go date got postponed.
No.
Sundeep, I think, Aditya's question is more regarding why it was lower than the immediate preceding.
That's right.
Let me tell you that, for us, we have an element of dosier income, as we call it, or service income against milestones on some of the other product which come in.
Yeah.
It is that which has fluctuated, not the commercial supply.
Okay. Okay. Last year you got some dossier income or some milestone payments?
Yeah.
-from the other products which you didn't recognize this quarter.
Yeah.
Okay. Understood.
Had this approval come in, we would have got straightaway the-
Yeah. What he means is you would have not seen the dip.
I understand. I understand. We also launched Combigan sometime during the third quarter itself, right? The late half of the second quarter. I was just wondering why didn't Combigan sort of make up for the gap that was created by lack of dossier income?
Combigan actually went into the market by end of November only.
End of November. Okay.
Yeah.
Only one month of Combigan sales.
Only one month. Yeah.
Oh, okay. Okay. Understood. now coming to, the India business, right? Aditi, when you explained on the call that, you know, 5% or to 6% is the price increase that we have taken this year so far, right?
Yeah.
Going into the fourth quarter because we have that 12-month gap sort of situation with some of the non-NLM brands, will this 5%, 6% go further up or will this remain at 5%, 6% even for next.
No, it will stay the same.
It will stay the same. Next year again, given that the WPI may be again 12.5% and, you know, there will be a 10%, up to 10% on non-NLM, do you expect the price increase for next year also to be 5%?
Well, a couple of points more we can expect.
Okay.
Aditya, we have, as I said, we have a very unique portfolio compared to many of our peers with so much coming from pure acute.
Right.
Where, with GP as a customer, I think it is more with our boys, whenever price gets increased or them feeling there's a competitive advantage loss or something like that.
Right.
Added to which, you have the NPPA, you know, creating havoc as it is. We are little careful here. A lot of our products have a repeat purchase element attached to it.
Okay.
Not entirely driven by prescription, which is why we are a little cautious compared to many others. Yeah, by next year, you can expect at least 8% to come down.
What would have changed, Aditi, between this year where we could have taken seven, eight, versus next year we're taking eight? I mean, why...
We pushing the marketing guys.
You're pushing your internal team to basically live with a higher price-
I have realized, Aditya, this year my internal customer is a lot more valuable than my external customer. Whichever way.
Makes sense. Makes a lot of sense. Just one, a couple of questions on the gross profit. Now, again, we saw a material decline in gross profits, sequentially. I'm talking Q2 versus Q3. I am aware that the India sales is seasonal, 2Q being the best quarter and 3Q not being the best quarter. Your US sales also declined, which I am assuming would have been lower gross margin compared to India. Your mix is actually essentially flat from 2Q to 3Q. Your gross margin fell from 70% to 67%. That's a 3 percentage point dip.
No, as I explained-
Mm-hmm.
we had lower dossier income for U.S., which is why.
That basically flows down. Yeah. Okay. Okay.
Again, had this INR 10 crore come in, you know, you would have seen margins equivalent of the previous quarter.
Mm-hmm.
Yeah, I see that.
Until our size of business remains not very large for U.S.-.
My question is.
This kind of, you know, quarter-to-quarter variations you can expect.
Yeah, this will happen. No, I get that. There's also that Forex element in the other operating income which also implements.
Right. That's also-
This also increases your cost margin. Yeah. No, I get that. Just a couple of last questions on the cash flows, Sundeep Sir. What was our cash flow position after the third quarter?
No significant change, as compared to the second quarter.
Okay. In that case, what is the CapEx that we are doing this full year, sir?
This whole year CapEx would be in the range of whatever figure we quoted in the beginning of the year...
100 and-
It remains intact.
Yeah.
INR 125 plus, the CapEx at Goa as we discussed.
Around 150, right? 150?
Yeah.
Yeah.
Yes. Including Goa Line pipe.
Mm-hmm.
That's INR 150 crores for FY 2023 M&A, Prabal?
Yes, Aditya.
Okay. For 2024, what are we expecting in terms of CapEx?
That's still going on working.
Yes.
Mm-hmm.
We'll be able to clarify that position before end of March.
Right. just for my understanding, Sundeep sir, we don't need any CapEx for Europe, right?
No.
No.
We don't need any significant CapEx for U.S., but because we just added a sterile line, if I'm not wrong.
Yeah. Aditya, we want to de-risk our sales from a single sterile plant.
Mm-hmm. Okay.
To that extent, some drawing board activities will start.
Okay.
Certain CapEx investment will begin.
Okay
for that.
If I understand the statement correctly, Aditi, you are saying you want to develop another sterile site?
Yeah.
You will basically have that added to all your current dossiers to ensure.
Yes.
You are de-risked, quote-unquote?
Right. Right.
understood.
No CapEx required for solid orals.
Yeah. Yeah. No, that I get it. Now that is my other question. You know, as an investor, what I saw immediately preceding this quarter results was that you had a issue with the FDA on the oral solid Goa 1, right? Your Goa 2 is up for, you know, inspection whenever the FDA desires to, because it's more than two years. All of us understand, at least given our experience with equity markets, is that sterile compliance is far more tougher than the oral solid compliance. The worry that investors now have, Aditi, is that if a company is not able to maintain oral solid compliance, when the FDA audits the sterile compliance, how, you know, difficult it's going to be for the company.
What are you doing incrementally now to ensure that, one, your oral solid compliance falls back into place, and two, your sterile doesn't fail the compliance test?
First and foremost, getting Form 483s doesn't mean your plant is not compliant. Okay? Because we are bound with what we can and cannot disclose with you.
Right
...until our responses to FDA go and until our updates to them on everything that we have committed are done. I cannot share details of my Form 483s with you. I think they will come on the site.
Yeah, they do.
Yeah, 8-10 days' time.
Yeah.
You will realize then that, you have less to worry about plant not being compliant.
Okay.
Okay. We learn every time they come down.
Mm-hmm.
Your second question on sterile is tougher, how do you bend back and all. There is a QMS, entire section of QMS which works on bending backwards.
Mm-hmm.
FDA also expects that if something is identified on one site, it is done at all sites. That is a routine practice at Indoco. Any improvement measures which have been suggested at plant one would be implemented in plant two parallelly.
Mm-hmm.
They will expect that. Now, regarding, yes, sterile plants are difficult, et cetera, et cetera. All sterile plants are tough to manage, run, whatever. We've been through a very, very tough period for our sterile unit and come out of that. We have also several FARs filed from that site, some recalls done from that site. It's not as if plant two and FDA are not talking to each other.
Mm-hmm.
The communication is on even if they are not auditing.
Mm-hmm.
We wait and see, and we are quite hopeful. We have one pass expected audit on the two, three site, which is one site, more on solid orals. Definitely steriles are due.
Okay.
We are installing new lines, so whenever those lines have to be qualified by FDA, they will come down.
Right.
FDA coming down, suggesting improvements, those getting classified as 483s is a part and parcel of our life now.
Yeah.
That does not mean business stops. Except after our first four-year warning letter, we have never stopped any business anywhere.
Sure.
The overhang of a warning letter or that there are Form 483s , and therefore would result into something, I think I'm not saying it's not a perceived risk, it definitely is. I think as you are getting more and more informed about how this works, you could classify it as an event which is going to be part of everybody's normal life if they are going to be supplying to US.
No, that's right. I understand your point. Therefore, you know, when we spoke of your vision, your sort of the conclave that you had, management conclave, where you guys see a lot of potential in the export business, right?
Yeah, yeah.
Whenever you achieve that INR 5,000 crore milestone, the contribution of the India business will be significantly lower than what it is here today. Today, Aditi, in the pharma, you know, entrepreneur world, we see two types of entrepreneurs. One is, let's say, a Torrent, Nanvan. Essentially how their business is growing is that they are generating cash flow from the current business and they are deploying it in buying brands for the India business.
Right.
Basically the business that generates the cash is getting the capital allocation.
Right.
To get more cash in future.
True.
The other set of entrepreneurs is like, you know, Indoco, where you have maybe exports is not generating much cash today. I'm sure they're generating some cash, but not much. India business does most of the heavy lifting. The reinvestment is again happening in the export business because that's where you see the true potential. When you weigh the risk and reward of reinvesting the capital coming from the India business, to invest in Europe or in export or India, doesn't India turn out to be a safer bet or?
No.
Does the scale?
Yeah. I get what you're trying to say.
Yeah.
Aditya, considering that half the world market comes from U.S. alone.
Yeah.
You cannot ignore that market if you want to get to any kind of size.
Mm-hmm.
Also be in very exciting kind of space.
Mm-hmm.
With that in mind, after our initial years of contract manufacturing for Europe, the intent seriously was to do U.S. Okay?
Mm-hmm.
It's only because of the regulatory challenges we had that it got postponed a bit.
Yeah.
I think, since this year or last year, the reinvestment we are willing to do in international is now only to the extent of what they can manage. This kind of, you know, India sort of subsidizing the international is, it had to be done until the international business got to a particular strength.
Mm-hmm.
Size where it could stand on its own two feet.
Mm-hmm.
That is behind us now. You will see at Indoco also where we start inclining a little bit now more towards the Torrents of the world.
Mm-hmm.
Save maybe, one unit for sterile. I don't see any other capital expenditure going towards international business from this day forward. Our R&D also, which does work largely for U.S., we are now sort of filing the same product globally.
Mm-hmm.
Looking at some of those products even for India. Everything is getting. The kind of, over the last decade, the kind of investment, CapEx and otherwise you saw for international, from the profit generated from India, that may not happen going forward. It won't be needed also.
Yeah. Precisely. My suggestion simply is, Aditi, to you is that, you know, this year you're doing INR 150 crores of CapEx. Most of it is obviously U.S. and Europe. I'm sure they're not generating that cash this year. Next year if you're planning INR 100-125 crores, maybe, you know, you do that only if they generate that kind of cash.
Correct, correct. Agreed.
India should not really be subsidizing them anymore.
They won't. They won't.
Yeah.
See, there is a time for each. While India was doing this, we did not also invest in India, you know that.
Yeah.
We have not added divisions. We are not, our entire CMO thing also started after we knew we could now relook at this.
Correct.
We did not want two disruptions.
Right.
One business was steady and doing their thing.
Mm-hmm.
Next year you can expect some more disruption in India for the good.
Yeah. That's good. Next year basically the cash flow that India will generate, India will consume, not U.S., Europe. Right?
Most of it.
Yeah. Okay. No, that's good to know.
That's for my kids only, no?
Yeah.
Can't abandon.
That's what we love to see, the cash flow of India being reinvested in India.
Right.
Rather than subsidizing the other businesses. That's all I wanted.
Aditya, you must understand, you might be reading some articles which have started coming back about what goes down comes up U.S. kind of.
Yeah.
I know you are very passionate about India as much as I am and many of us are.
Right.
We have to understand, like I said, there is so much opportunity out there.
Right.
Sometimes when people stop seeing opportunity and they retract is also a great time to stay there, because you get yours. We have got a very nice niche-
Right.
With injectables and Ophthalmics. Delays will happen here and there, some regulatory issues. I'm not really bothered about the space that we are in.
I see.
We are good. Okay?
No, that makes a lot of sense. As long as the compartmentalization is in your head and you, we stick with that, I think.
It is there on paper. It's at business levels. It's everywhere.
Yeah. That's awesome. I mean.
If you ask me, I'm not going to tell you.
No, I know that. I know that. Hopefully someday you'll achieve a scale in U.S. and Europe.
Yeah, we will.
You can start doing segmental reporting. You can start reporting India as a separate segment and export as a separate segment.
Reporting to you mean.
For the record.
To me it already reports that way.
Yeah. Right.
Right.
Profit and assets also.
Okay. Okay.
Today you report only top line.
Yeah, yeah. True.
In segmental reporting, you're required to report-
I know.
Assets and profit.
Got you.
Okay. Thanks a lot for taking my questions, Aditi. We look forward to next year when Europe and U.S. will be self-sustaining in terms of cash flow.
Right. Right.
That's a very important milestone.
Right.
Thanks.
We have another question from Aegis, Unifi Capital. Please go ahead, sir.
Yeah. You know, Mitesh, in case anyone else is there, I'm just using the opportunity. Sundeep, sir, actually, you know, if you could give, you know, we know that in the U.S. market, Ophthal, there are very few players, Samsung, Novartis, Bausch Health, Allergan, you know, Alcon. Could you just speak about how the Ophthal players are evolving? How is the market formation really taking place? How is the evolution of the industry taking place, and is there any incrementally new competition really in Ophthal?
See, it all depends on how the top players are performing. Majorly, there have been all these players which you have talked about are doing exceedingly well, you know, in Ophthals. The biggest advantage of Ophthal and injectable market is that once a product goes generic, the prices don't crash like solids. To give you an example of lacosamide injection, the market before it went generic was $43 million. After going generic, after a good 3- 4 months, it had grown to $48 million. That's because Indoco and its front-end partner were the only company selling this particular generic. As a result, the units went up, although the price was lower than the innovator price. The number of units went up, and as a result, the market stayed wherever it was.
There was no crazy competition like 15 or 20 people entering the market and, you know, damaging the market totally and prices crashing to 99%, below 99% of the innovator. That's the first point. Secondly, it will all depend on how we as a company can introduce more new products through our R&D, our new injectable and Ophthal pipeline, which we are very much eager and passionate about and in the process of doing. Going forward, I think evolution of the market will depend on how many players enter. As of today, it's quite niche because not many Indian players are entering the market and damaging the price. That, these are the two factors which I see.
Got it. Sir, just a follow-up. Brinzolamide, it's, you know, Novartis, Bausch Health and then us, right? They're just, it's still a three-player market only at the moment, right?
3-4 players, yeah.
Okay. Sir, what is the size of the market today for Brinzolamide?
It remains around.
INR 400 million?
INR 80 million.
Okay. INR 80 million market?
Yeah.
Okay. This is post the generic.
Yeah, yeah, of course.
Right. Okay.
Post all these players coming in.
Okay. sir, lacosamide, the tablets is the larger portion, not the injectables, right? Out of the INR 1 billion.
Yeah, tablets, there's huge competition.
Right.
When we introduced, there were already 14 players in the market.
Got it. Sir, out of that billion-dollar lacosamide market, how much would be tablets and injectables? I mean, the rough cut. You said $48 million-$50 million is injectables, the rest of it is all tablets.
Yeah, that market has crashed already. It's no longer a billion-dollar market.
Okay. The injectables are still holding through?
Correct, correct.
Got it. Sir, for Combigan, what it's, you know, again, Apotex, Sandoz and Allergan, right? That market, you know, is whatever, $400 million give or take. How do you see that market, from a, you know, post-generic, what kind of size do you see for that?
Since we have just started selling, as I answered Aditya's question, you know, from end of November onwards, we'll get a good hang of it within a month or two.
Got it. Okay.
Yeah.
Okay. Sir, still three players only, right? The innovator and...
Yes, yes.
Your partner.
Currently three to four players only.
Got it. Got it. Perfect, sir. Thanks a ton.
Thank you.
Reminder to the participants, to ask a question, please use Raise Hand function or comment directly by introducing yourself and your company. Mitesh, as the queue assembles, if you have any questions, please go ahead.
Yes, I have a few questions regarding U.S. again. U.S. would look like a key driver for us and be one of the fastest growing, no doubt about that. Can we think about the front end team over there for especially over a period of time on injectable Ophthalmic as well?
I'll commit for that. Mitesh, we have been looking at a front end, setting up a front end for some time now, but we are very clear that you have to have a portfolio of a size that merits that. Okay? Because costs of running a front end operation in U.S. are not low. A, you need a substantial number of ANDAs, 25+ running, and commercial of your own is when we were planning. Baby steps have started. We have done exploratory work. We shall see. It's only when we can absorb that it is possible. That is the thought process.
When can we see that actually?
When it happens, we will tell you.
Okay. Sure. The US, what would be the contribution of the oral solid in the overall portfolio and-?
Very small. We just have one glimepiride and one allopurinol. Allopurinol volumes will now pick up. I don't know what the numbers exactly of a contribution, must be very small. Pramod, do you have it? We could share it with you separately.
Thank you. Yeah, sure. Sure. Another question is regarding your margins. Actually, can you tell us that on a hierarchy-wise, what would be the highest margin, and then after, what would be the lowest one?
For what? Product, geography, market?
Topographical-wise. I would say that. If the U.S. would be the highest contributor or the India.
Yeah. India, U.S., depending on product mix, pretty much close. Followed by emerging, followed by Europe, followed by UK, roughly. Yeah.
Got it. Got it. The Over a period of time, you said, you guided about the INR 5,000 crore top line. I think, what would be the geographical mix? Because U.S., like, currently would be just mid-teen for us. It would be like a higher means one of the highest contributor or the, like, second highest after the India.
Yeah. Second highest after India.
Okay. The way Aditya has said, most of are looking the U.S., sorry, Indian market, and most of the larger players are shifting their focus into Indian market because one particular size, it's difficult for the any of the company to be survive in the U.S. and not survive, I can say the consistency and the growth is always a challenge for any of the companies once the size will be increasing. What's your thought on this actually?
Actually what you say is based on your understanding and trend. Frankly, since we got listed in 2005 right up to today, for me, there have been seasons when people have preferred companies having business in U.S. or having business in India. I remember when we got listed, people used to ask me how many ANDAs you have, and we were only in India. We didn't have anything else. I guess your perception changes based on how majority of people in the segment are doing and what they share with you. As far as Indoco is concerned, we are very clear.
Whichever geography we are present in, whether India, U.S., Europe, API for that matter, and including our services, we are very clear that we are in businesses which make sense to us, for, even for our size, where we are making it's an advantage. We will continue to pursue that. I think most companies do it. We like the fact that we stay de-risked. How much you want from each and, where the contribution will come from or not, that is where management makes decisions, I think. It's not about being or not being there. You don't totally take a U-turn. Of course, if there is a new company today, they may decide they don't want to be in India, they don't want to be in U.S.
A company of our size, stature, and age, you know, 75 years and contributing every year is not easy. I think we've been able to do that because of how we are. You know, we have various geographies, we have various disease segments. Sometimes it may seem to the outside world that that is defocused. We feel that is de-risked. Okay.
Sure.
Yeah, I agree. Like Aditya said, you may focus on where you want to spend and not spend everywhere, but that doesn't mean you don't exist in some geographies or something like that.
In India, part of the organic growth, we continuously looking the inorganic opportunities because most of us are nowadays doing this.
Yes, we are. Yes, we are. As you know, values have to be sensible also for that.
True, true.
Also, if you See, it takes two, three years to create an INR 10 crore brand now for Indoco. You know, or max two years at the best. To buy anything, unless the brands are that kind and valuable, it doesn't make sense.
Another question on the CRO front. I have never seen any formulations companies offering their own CRO strength to the others.
All have.
You are doing this.
All have. They have different names. Ours is called AnaCipher Marketing.
Got it. Got it.
Most have, and people have no issues with us. We recently expanded and doubled our capacity for outsiders because there is so much demand and we consume 60% to 80% of that capacity.
Got it. Got it. I think that's it from my end, any participation?
Yeah. Right.
I have any questions.
Thank you. Bye.
Final reminder to the participants. To ask a question, please use Raise Hand function or come in directly by introducing yourself and your company. Mitesh, if you have any questions, you can. Else, we can conclude this call.
Yeah, I think, so I'm done with that. Thanks, Aditi madam, and all the management and the participation for part of this conference. Any closing remark you want? I think we have spoken quite a lot, but the management is extremely confident about its performance. As we said earlier also, here and there slight blips should not be taken, as you know, the real performance of the company. The order book for US and Europe is extremely healthy. We look forward to a really good performance this year and for the years to come. Thanks a lot, sir. On behalf of Nirmal Bang Equities, we'll conclude this call. Thanks a lot for your participation.
Thank you, sir. Thank you.
Tha nk you, Mitesh.
Thank you.
Thank you.