Thank you so much, sir. Ladies and gentlemen, we will now begin with the question-and-answer session. The first question comes from the line of Shashwat Vijay with SIC Wealth Management. Please go ahead.

Yeah, hi. Am I audible?

Yes, sir, you are. Please go ahead.

Yeah. Congrats for a good result. I just wanted -- I just have two questions. Firstly, it was that as you said that the industry pricing pressure cycle is still on. I wanted to understand what is the

management thinking? Will there be any margin recovery in H2 or will it take more time? Will it go to FY28?

See, I believe that in the -- in the non -regulated market, the competition will continue, and generally, it depends on the cycle of demand. So, it's very difficult to predict in that -- in that area. But for us, what is important is the regulated market demand, which also is kind of cyclical, and we have seen that the quarter where we have more of the regulated products demand, that is much better. And I would consider this quarter as a med iocre in that terms. So, we hope in the next two, three quarters our demand for the regulated products will improve, and we can do better performance.

Okay. And another one was that since the Jammu facility of 7 -ACA will, you know, start in February 2027, so I wanted to know what's the expected ramp-up curve and utilization trajectory for that facility? And how much will be the output be captive and how much will be a third-party sale?

Hi. So, our ramp-up plan is to go to about 80% to 100% by the end of the first year. Initially, it would be slow and then increasing progressively. With respect to utilization, our long -term guidance on this is 80% in-house use and 20% selling to third party. Initially, the entire product would be used in-house as we develop customer approvals from the new site because it's a pharmaceutical product, so our customers would have GMP approval cycle. Once that starts, third-party sales can also start.

Okay. Thank you. That's from my side.

Thank you. The next question comes from the line of Tarun Krishna with ithought PMS. Please go ahead.

Thank you for the opportunity. So, is it like exports of 7 -ACA from China to India is concentrated with two to three Chinese companies or is it like there are a lot of companies which export to India? And if you can name some of them. And another one, are you expecting them to drastically reduce their prices once our 7-ACA site is fully commissioned?

Yeah, thanks for the question, Tarun. It's concentrated between three to four companies only. Not too many companies make this product. It's a complicated fermentation synthesis. The second question is with respect to price reduction. So, although you can't pred ict the Chinese, but what I believe is all the companies are now want to make profit. It's different situation compared to what used to be 15, 20 years ago when the state was funding most of the companies. So, private enterprises want to make profit. The pricing in 7-ACA has been stable over the last 10 to 12 years. The weighted average is about USD60. So, we believe that there is not much room to reduce prices drastically.

So, there's a company called Sinopharm Weiqida. There's a company called Zhuhai United. Then there is Yili Pharmaceutical. And there's a company called Livzon Pharma.

Okay, got it. And next one on commercializing Cefepime-Enmetazobactam. So, for the countries that we have signed the marketing partnerships with, will we be also manufacturing the products for those partners?

So, we have acquired the asset from Allecra, and they already had a CMO in China. They have a long-term agreement of providing the product from their CMO in China. So, the -- the supplies will start from that CMO itself, but we will have our margin in the supplies. And we do have the right to start manufacturing, and as our cefiderocol project will get started, say, in the next year, then we will take validation batches and hopefully, after two years, we would be able to -- once we are able to register the product from our side, we would be able to supply some percentage from our side. That's our long-term plan.

So, currently, before -- we are not producing Cefepime-Enmetazobactam for the partners. It's fully imported…

No, we are producing for our consumption for domestic market. We manufacture and supply to Cipla, and we sell in our own brand, Orblicef, in India. That is manufactured by us completely.

Okay, so all the international sales of Cefepime-Enmetazobactam is from the third party?

It will come from our CMO in China to begin with. And slowly, we will -- we will, you know, get registration from our site and partially start to supply from here also.

Okay, understood. Understood. And the next one on GCLE, so can we talk around where exactly is this product used in our value chain? And will commencement of our 7-ACA plant affect our procurement of GCLE?

No, it will not. GCLE is used for different products and 7-ACA is used for different products.

Okay, got it. And our share of business with Otsuka Chemicals has been increasing since the last 5 years. So, what would be the reason for this?

I am not really aware…

You are talking about from the related party report, are you reading from there?

Yes.

Yeah, absolute value, yeah, but as if I take it as a percentage of our material cost, that number has been increasing since the last 5 years. That's the point I am coming to.

I am not sure which number you're reading from, so unfortunately, I cannot clarify further on this call.

Actually, the prices also vary and the volumes vary depending on our demand, so that would have led to some changes. But as such, in a strategic alignment with Otsuka with respect to GCLE, there is no change. We procure our 100% GCLE from Otsuka. So, the value -- values may change depending on our demand and the pricing factor.

Okay, that's helpful. Thank you.

Thank you. The next question comes from the line of Nishita with Sapphire Capital. Please go ahead.

Yes. Hello, am I audible?

Yeah, Nishita.

Yeah. So, I just wanted to understand with the new facility coming and everything, what kind of capex have we budgeted for FY27?

So, as such -- we have not considered very significant capex in the next financial year. In this financial year, we will be completing our projects of cefiderocol and 7-ACA.

So, the entire capex would be spent.

Okay. Can you quantify the capex?

Yeah, it's already there in the presentation, but INR750 crore s is for the 7 -ACA project and USD20 million to USD25 million, I don't remember the crore s amount we have disclosed, for the cefiderocol project.

Okay, understood. And my next question is on -- so you mentioned that for regulated markets also, our demand is cyclical. So, like can you specify more like in which quarters do we have more demand? You mentioned that Q1 was mediocre in that sense. So, like if you could say, is H2 better for us in regulated markets?

Yeah, last year trend, we have seen that the second half is generally having more demand from the regulated. It's probably the winter season there.

Right, right. So, like can we expect the Q-o-Q growth to be better than in H2? Like in this in Q1, we had a 15% Q-o-Q growth. So, can we expect that growth number to be better in H2?

Okay. So, like if you could give some sort of guidance Y -o-Y, what sort of growth can we do for FY27, because we are going to have a Q -o-Q growth. So, I am assuming we can like -- can we achieve around 20% growth for the whole year?

I don't think it will be prudent to give you any number at this time.

Okay. Okay, that's understandable. Thank you so much.

Thank you. The next question comes from the line of Dhwanil Desai with Turtle Capital. Please go ahead.

Hi. Good afternoon, everyone. So, my first question is on the 7-ACA project, and I think in line with one of the earlier participants. So, what happened in Pen G with Aurobindo, you know, the way China dumped and the reduced prices, and we have seen that across many APIs where you start new capacity and try to take market share, China is just doing irrational pricing. So, do we have a plan B on that just in case if they decide to dump at a price which is not sustainable, what will happen to the capex investment, everything? Anything on that?

Yeah, I would say, rather than having plan B, we decided to have a good plan A. And that's the reason we went to Jammu, get some GST benefit, go into -- go to a state where the electricity cost is the cheapest in India, water is abundantly available, the boiler steam cost is lower due to available of abundant agricultural waste. So, and obviously, we are working aggressively towards improving our overall tighter concentration so that our yields can improve. Our pilot team, pilot plant team, is working towards that. I think the best you can do is use all your resources to improve efficiencies, and that is what our target is.

And when you compare with Pen G, what happened, Dhwanil, you know, we've talked about earlier in our other call, in Pen G, three of the large manufacturers came together and decided to collectively increase prices because they knew India could not buy from anyone. And because they increased the prices from USD10, USD12 to USD30, USD40, they had that opportunity to crash the price. You can see the price crashing after PLI. But in 7-ACA, that joint cooperation or whatever you want to call it was never happened, and the prices have been stable. So, therefore, I said I don't see much room for China to drop the prices. But having said that, they are unpredictable. Sometimes other things can still happen.

What he is trying to say is that even in Pen G, the Chinese have not dropped the prices to below pre-PLIs level. If you look at the prices of Pen G, the current prevailing prices are same as they were in 2019 or '20. So, because of the PLI, they had increased to probably create a war chest. They were preparing themselves to fight when the PLI companies start their production. And they brought it back to the normal level.

Like Mridul said earlier also, now these companies are largely privatized, and we don't know what future holds for us, but the intent is not as it used to be 20 years back to just flood the market. They want to work on a profitable model. That -- that's the general belief now for the Chinese companies, and we have seen in other products also. We believe that they are dumping the product, but whenever they reduce the price, they definitely have some cost advantage. So, we have changed -- at least I have changed my thinking about the Chinese. If I find that the Chinese are selling some thing cheaper, I would want to believe that their technology is better and I should look at my technology. That's my belief these days.

Got it, sir. Got it, very clear. Sir, second question is, I think we have a technology partner and I think they also supply to the Chinese manufacturer. So, do we have only the process technology transfer, or the strain part also is given by them because the yielding strain will make a lot of difference in terms of the end competitiveness? So, how is it working?

We have a comprehensive agreement with them. They will handhold us during manufacturing process. They will support us in the production stabilization. They will continue to develop strain and provide with better strains when they come up with that, and they will help us in improving the technology over the years. They have some incentive to give us those improvements.

Okay. Okay, got it. And last question, so, sir, with all this in place, typically, we've seen that fermentation product takes a longer time to ramp up. So, where are we today? And when you say commercial batch, I think that would be a very -- I mean, the first part of the ramp -up. But eventually, the stabilization will take, you know, what 12 to 15 months? Is that the timeline that you guys are working with?

We've guiding 12 months, but you know -- and I have said that again earlier that Aurobindo looking at other experience, it might be longer . Although we have, like Mr. Manish said, the technology partner with us all the way to make sure the risks are lesser. But it is something unpredictable, and we wait -- we'll have to wait to see what actually happens. We've been successfully been able to commercial -- scale up our existing pilot plant by 20x, and we have to another do about 800x from there to Jammu, but it's a little unpredictable. We still remain hopeful that we'll be able to reach full utilization in one year, by the end of one year.

Okay. And we'll come to know the end out put is including in terms of quality, yield by March, right? That's a fair way to -- so, 20 to 800x that you are talking about, that will happen in February, March of '27?

Yeah, the first batch, yes.

The first batch, yeah.

Okay, got it. Very clear. Thank you.

Thank you. The next question comes from the line of Rupesh Tatia with Long Equity Partners. Please go ahead.

Hi, Manish. Hi, Mridul. First question is, some data you gave on vials. I don't know if it was for Enmetazobactam, so could you please just repeat that?

Which one?

Russia?

Yeah, USD178 million for Russia, that's what you are talking about?

No, no, no, for vials. You gave some growth data, Q2 these many vials, Q3 these many vials, so what was that? So that data, if you can repeat it.

Europe number of vials growth data, we were just trying to talk about how the business is growing in Europe as more and more markets get added. So, in Q3 FY26, there was a 300% growth Q-o-Q, and in Q4, over Q3, it was 175%, and in Q1 FY27, there was a further 50% growth over that. So, as the volumes are increasing, we are seeing this J -curve continue to play out. That's what we were trying to shape.

Okay. Okay. So, in -- now has Advanz Pharma launched the product in all the markets where it is registered?

Sorry? Advanz Pharma what?

Have they launched in all the markets or are there still some markets where launch is pending?

Advanz Pharma is focused in Western Europe. Big five would be their largest markets, which is Spain, Italy, Germany, France, and UK. They've launched in all of those big five markets and some of the other Nordic countries. But for Eastern Europe, they will have B2B partnerships that they will forge. They have the license for full EU, but rest of the Eastern Europe, they've not made the partnerships to launch yet.

Okay. Okay. And I mean, I don't know, at what point does this Advanz Pharma stream start becoming, you know, 5%, 10% of the revenue? Do you think it is FY28, FY29?

I would not guide on Advanz Pharma specific -- specifically becoming 10% of our revenue, although I would be happy to see that. So, our long -term guidance on this is remaining the USD1.1 billion to USD2 billion that we came up with in 2021. And looking at e ven the Russia numbers, we remain optimistic that the partners continue to believe that it's a viable asset. But to actually sell a product and get value out of it is a long-term thing, and things can change over time. So, it would be difficult to say the answer to your question.

Okay. Okay. And Russia, what are the timelines for registration and commercial launch?

So, the agreement is just signed. We announced last month. And since that time, I think registration dossier submission and launch would take about 1.5 to 2 years.

Okay. Now coming to cefiderocol, any update on trial waiver? How is that discussion going?

Sorry?

Trial waiver, right? DCGI, we have to do a trial for cefiderocol for launching in India, and I think we are hoping for a waiver on that.

Yeah, that we will come to know only after we apply. So, as you know, there's a process -- there's a SEC committee that sits in DCGI after your application. So, we are working with GARDP to engage the stakeholders in the utilization -- usefulness of the product and the strong unmet need in the country. But the actual result will come to know after the application.

Is there any precedent for the waiver?

Sorry?

Is there any precedent for here, you know, DCGI has granted a waiver in the past?

Yeah, yeah, our Cefepime-Enmetazobactam itself is a precedent. We got the waiver because the committee thought that the -- because of the antimicrobial resistance, the country needs new antibiotics. So, we ourselves have got this waiver, that's why we are more hopeful, actually.

I see. Okay. And this GARDP RFQ, do you see any registration or regulatory approvals? How does that work because for 125 countries or just WHO enables you to supply to 125 countries , WHO certification?

Yeah. So the overall target is that getting the WHO PQ. If you get WHO PQ, then the process of registration in many countries becomes very simplified. And when the product is distributed by non-profit organizations like CHAI and GARDP, then it becomes further, I would say, faster. So, our target is to file with the WHO Geneva and get the PQ.

How much time does it take to get a PQ after filing?

It takes 2 years, around 2 years.

Around 2 years.

We are banking on our sales in India, I think that will be our first market.

Yeah. So, Rupesh, we just talked about that strategy first time last quarter, and the guidance is still 2030. I don't think there will be quarterly updates on that. We'll be sharing possibly annual updates on that only. So, things won't move much in Q-o-Q, quarter-to-quarter.

But I mean, have you -- I don't know, have you started looking at the products?

No, no, the products are already identified and part of our presentation, which products we are going to launch. So, it's Cefta -avi, Ceftaroline, Ceftolozane-tazobactam, 3 new molecules, and three older molecules in Cefepime, Ceftriaxone, and Cefazolin.

Okay. And where are we on ANDA filings, DMFs for those? Are we also looking for some distributors in the US?

Yeah. Those will take time. For the generic molecules, we'll be using our Cefiderocol facility to file, so that will require taking validation batches, US FDA approval, filing, all of that, which will take few years' time. For the newer molecules, we'll be using a CMO to launch faster in the market, but nothing starts before 2028 sometime. Some of the new molecules might be filed by end of next year, but nothing before that.

Okay. And what was the EBITDA loss for AMS division in quarter 1? Where do you see that for the full year? And how is the discussion to get distribution license for Cefiderocol?

It was around INR50 lakhs for this quarter.

Sorry?

About INR50 lakhs for this quarter. The results were much better than the last quarter.

Okay, okay. And I mean, if you can share the number also, revenue number from that division?

Yes. It was a revenue for AMS was INR5 crores.

Cefiderocol distribution, I mean, whatever process license.

Cefiderocol is…

No, not Cefiderocol. The Orblicef and we have couple of other brands that sales through AMS division was around INR5 crores or so.

Yes. Cefiderocol is not launched

Yeah, but eventually we are looking to become a distributor of cefiderocol, right?

Yeah.

Yes. We are building this network for cefiderocol launch itself. That is the main purpose, and we are in advance discussion to finalize our distribution agreement with GARDP.

Thank you. Our next question comes from the line of Nishita with Sapphire Capital. Please go ahead.

Yeah, thank you for the follow-up question. So, I just -- if you could just reiterate, when are we going to, like, start commercial operations in both of our projects, 7 -ACA and Cefiderocol? I missed it, if you could just repeat that.

7-ACA is March 2027, and Cefiderocol, facility would be ready by December, and first product approval will take 6 to 9 months from there for Cefiderocol approval in India depending on DCGI granting the clinical trial waiver. So, that would be Q3 of next financial year.

Right. So, 7-ACA revenue contribution we can see from FY28, right?

Correct.

Okay. Thank you so much.

Thank you. Next question comes from the line of Ankur Chedda, an Individual Investor. Please go ahead. Ankur, you may please proceed ahead with the question. Thank you.

Hello, sorry, yeah. Just one question, is there any risk to the PLI benefit due to the slippage in the timeline, or has that matter been settled with the government?

Sorry, can you repeat the question?

PLI, we'll probably be entitled for 2 years. Based on the current scenario, we'll be entitled for 2 years.

Okay. So, any scope of getting extension on that?

We will maybe try for extension only once the plant gets started.

Okay. And just one more qu estion on this NPNC business, which came from Dhanuka Laboratories. So, in this quarter, of this 350 revenue, what was the portion of NPNC business?

We'll just come back. We'll check and come back. Just check. That's a relatively smaller part of the business as of now.

Okay. That's it from me.

Thank you.

Thank you s o much, sir. Our next question comes from the line of Prat eek Shrivastava with Nivesh Wisdom. Please go ahead.

Thank you for giving me this opportunity, sir. Sir, my question again is more broader. But beyond Cefiderocol or 7 -ACA, what are like the 5 target products that are probably furthest along in the filing and approval process, sir?

Sorry, I did not understand your question, Prateek. Can you repeat?

Beyond cefiderocol, what are like the 5 to 6 target products which probably are furthest along in the filing or approval process, sir?

So, there is -- I mean, it depends on which market you are talking about. Like, we have recently launched this product called Ceftaroline in India, and our brand is called ORTA RO. This is a molecule which was only provided by Pfizer, and they have -- they are trying to withdraw this product from India because probably their cost -- manufactured in Europe is not viable. So, like that is one product which we will slowly manufacture and export to other ROW countries. And if you are talking about the U .S. market, that is one product, Ceftaroline, which we plan to file ANDA. And of course, Ceftazidime-avibactam combination is another product that we wish to file in the regulated markets. Then after that, in the pipeline is a molecule called Ceftolozane and Tazobactam. That is in our R&D stage at this point of time. So, we feel these are couple of molecules which are going off patent in the injectable space, and relatively there are less number of players who can manufacture such complex molecules, first of all, and less number of regulated market facilities for the cef-injectables. We feel that will give a significant edge to Orchid in the coming years.

Correct. Thank you, sir. And another one more question on the Enmetazobactam, sir. I think you, if I am right, you mentioned that $1 billion to $2 billion lifetime sales potential with peak at around, year four to five post launch. So, and I think we are active in India, but any other markets or regulated markets today we are active with this product? And what could be the realistic revenue contribution from this for FY27?

No, Prat eek, we don't give yearly numbers guidance on this. The $1 billion to $2 billion is lifetime sales, not the fourth year or the fifth year sale. And besides India, it's already selling in Europe, and GCC is approved, which is the Middle East market, and South Africa is approved. Launching would be short, shortly it would be launched. And like Mr. Manish explained in his speech, we are talking to several markets in Latin America, Southeast Asia, U .S., China, to launch it in other geography. We hope that by end of this financial year, it would be launched in three, four agreements would be in place for three, four more places, out of those.

Thank you. Our next question comes from the line of Vishal Manchanda with Systematix. Please go ahead.

Yes. Hi, good evening, sir. Thanks for taking my questions. On 7 -ACA, have we seen any material price changes on a quarter-over-quarter basis?

No, it's pretty stable for last one year.

And on our final APIs like Cefixime, Cefuroxime, are they also stable?

Cefixime is the one having maximum pressure. Cefuroxime and other 7 -ACA-based, fortunately, seem to be more stable compared to Cefixime.

Okay. But on Cefixime, would that spreads be narrowing or the spreads remain the same?

Cefixime does not start from 7-ACA. That starts from Pen G and GCLE.

Yes, but the spreads are kind of going down or they remain as they are?

Yes, Cefixime as a product is under maximum stress with respect to margins.

Okay. And is it so for even the regulated markets or it's only for the rest of world markets?

It's for the rest of the world market is where the volumes are huge and that's where the pressure comes from.

Okay. Anything that we're doing to kind of get reduce our dependence on this product, since this is Pen G derived and we're not backward integrated there?

Yes, I mean, we are trying to work on other products, and we have couple of other products that we manufacture in Dhanuka. We are trying to create a situation where we remain the sole player of those products. Our focus, our strategy is completely different from our competitors, who are more focused on the volume busines s. We are more focused on the value -based business and more of a diversified portfolio. If you see the competitors in cephalosporin right now, we are the only company which can make about 20 to 25 products, whereas the others, they make three or four produ cts and focus on the volume. So, our strategy per se as a cephalosporin player is completely different from our competitors in India. And how it plays out, I mean, tha t is the reason we, I mean, we could see that the generic business of cephalosporin API is going to become a low -margin business, and that is the reason we sought to go for a backward integration and a forward integration. And in that mission only, we decided to set up 7-ACA and the injectable facilities. So, we think we are trying to de -risk ourselves from the traditional API business, which is becoming more competitive.

So, post like once you have 7-ACA, is there like Ceftriaxone is potentially another large market within the cephalosporin space. So, would we , is there an opportunity for us to scale up there and kind of, and kind of scale up quickly there in a shorter timeframe?

Yes, that's our plan. So, for Ceftriaxone, not just sterile, we would be supplying to all other players like Aurobindo and other sterile players in India the non -sterile part, which they are currently importing from China. So, the market is not just our own sterile product, but our competitors also become our customers.

Okay. So you will supply the non-sterile version, not the sterile version?

Yes, absolutely.

Okay. But would you have capacities to sell the sterile version too? Your sterile , are th ere adequate capacities if you want to do that?

I would not say our sterile can completely consume our 7 -ACA capacity, but we are re - engineering our non -sterile capacity so that we are able to convert the product and supply the non-sterile. I think that is a better model rather , you see, I mean, selling a sterile product needs an approval process, which is more long drawn. So, it would make more sense to work with our other players in India. Then there are three, four players, they can take large part of your volume production, rather than getting approval process in 200, 300 customers. It's better to collaborate with these four manufacturers of sterile who already have the capacity and who already have worldwide approvals. So, I don't see much benefit of competing and creating overcapacity. We would rather collaborate with them.

Understood. Understood. And sir, on Zavicefta, you had once indicated you have been trying to do a non -infringing route for an early launch in Europ e. Is that work under progress, and any timelines to that?

Yes. I mean, we have customers who are taking this product for us for their own development. We also have plans to take our own validation batches and file in Europe. And the U .S. plan, although unfortunately last filing had some objections, we still continue to have plans to re-file, and that is going on.

The filing should be, should happen this year for in the U.S. for Zavicefta?

I am hoping maybe validation batches maybe this year or early next year, and then six months for filing.

Thank you. Our next question comes from the line of Rupesh Tatia with Long Equity Partners. Please go ahead.

Sorry, I am not sure what you're talking about.

In, in relation of battery, sorry in battery or solar, in a host of other industries, Chinese government used to give a tax refund to the manufacturers, and then government now is canceling the refund from April for some industries, April, some industries January, like that. So, my question is where 7 -ACA manufacturers in China getting this refund, and is it now getting canceled?

Honestly, not aware about this. We heard that slowly the VAT refunds are getting reduced, but not aware exactly of this.

Okay. Okay. And another question is, what was the sale of, NP-NC segment in maybe last year or this quarter? And any, sorry high-value APIs that you're working on in NP-NC?

Yes. So, this quarter sales was INR21 crores, and we are working on a couple of molecules. We are also planning to scale up and backward integrate in these molecules also.

So, that launch would be this year, next year?

Yes, I mean, it's a continuous process, you see, in synthetic. You cont inue to introduce new products. It's not something, I would not say it's a news that we would want to discuss on a large scale, yes. It's an incremental improvement that you continue to do in NP -NC synthetic. You have to keep working either by increasing c apacities or introducing new products, so we keep evaluating which options are better at any point of time.

But I mean, will it become, let's say, 20%, 25% of our revenue in three, four years?

25%, no.

Thank you. Ladies and gentlemen, as there are no further questions from the participants, I now hand the conference over to the management for the closing remarks. Thank you, and over to you, team.

Thank you. We thank you dear investors for your continued interest in Orchid Pharma. We value your input and feedback. Thanks once again for your participation. Thank you.

Thank you so much, sir. Ladies and gentlemen, on behalf of Systematix Shares and Stocks, that concludes today’s call. Thank you for joining us, and you may now disconnect your lines.