This conference call may contain forward-looking statements about the company, which are based on beliefs, opinion and expectation of the company as on date of this call. These statements are not guarantee of future performance and involve risk and uncertainties that are difficult to predict. I now hand the conference over to Ms. Loveleen Bagga from Systematix Shares and Stocks. Thank you, and over to you, Ms. Loveleen.
Thank you, Danish. Good evening, everyone. On behalf of Systematix Institutional Equities, I welcome you all to the Q1 FY 2027 earnings call of Orchid Pharma. We thank the Orchid Pharma management for giving us an opportunity to host the call. Today, we have with us the senior management of the company represented by Mr. Manish Dhanuka, Managing Director, Mr. Mridul Dhanuka, Whole-Time Director, Mr. Nishant Talal, VP finance, and Mr. Kapil Dayya, Company Secretary. I will now hand over the call to the company management. Over to you, sir.
Thank you. Good evening, ladies and gentlemen. I am Manish Dhanuka, Managing Director of Orchid Pharma, and I welcome you to our discussion on the results for the first quarter of financial year 2027. As you may be aware, on 10th of July, the merger with Dhanuka Laboratories became effective with an appointed date of 1st April 2024. Accordingly, the FY 2025 comparative and FY 2026 results have been restated to reflect the combined operations of Orchid Pharma and Dhanuka Laboratories. The financial numbers that we will discuss today are therefore on a combined and comparable basis. They will differ from the Orchid-only numbers discussed in earlier calls. As we had indicated in our last call, financial year 2026 was a difficult year for cephalosporin business. It was among the most challenging environments our cephalosporin franchise has faced in the last 15-20 years.
In a number of important products and markets, both volumes and pricing were affected with declines of 15%-20% depending on the product. On a restated combined basis, revenue from operations was INR 1,233 crore for financial year 2026, compared with INR 1,398 crore for the financial year 2025. After the first quarter, our focus was on protecting volumes and customer relationships in the challenging market. This involved accepting some pressure on margins, particularly because of product mix and pricing conditions. Consequently, combined gross margin moderated by approximately 4% to 32% in financial year 2026, compared to approximately 36% in financial year 2025. We remain disciplined on controllable costs. Combined employee and other operating expenses were broadly flat at INR 353 crore in FY 2026, compared with approximately INR 353 crore in FY 2025.
However, this cost discipline could only partially offset the effect of lower revenue and gross margin compression. Turning to the current quarter, we have begun financial year 2027 on a better footing. Revenue from operations increased to INR 304 crore in Q1 2027, from INR 263 crore in corresponding quarter last year, representing growth of approximately 15%. Combined gross margin improved by approximately 3 percentage points to 33% in Q1 2027, compared with approximately 30% in Q1 of 2026. EBITDA improved to INR 25 crore in Q1 of 2027, compared with EBITDA of INR 10 crore in Q1 of 2026. Though we can see some improvement in sales over last year, we feel the industry is still facing over capacities leading to cutthroat competition.
Our focus remains on growing volumes with discipline, improving product mix, maintaining tight control over operating costs, and progressively strengthening the underlying profitability of the combined platform. We have also started a number of focused integration projects to crystallize savings from this merger. We expect initial benefits of these initiatives to begin becoming visible in the next financial year. The AMS business continues to be managed with financial discipline. Its quarterly EBITDA drag has reduced significantly while we continue to build the platform and its long-term strategic relevance in antimicrobials stewardship. I will now move to the operational and strategic updates on other businesses and projects. Let me begin with Exblifep. We continue to make measured progress in building Exblifep as a global commercial platform. In Russia, the estimated 10-year value of our licensing arrangement is approximately $ 178 million.
This is an estimated long-term value and not current period revenue. Execution will depend on registration, launch, and market development over time. In Europe, the business is growing at a steady manner. Whilst volumes grew by approximately 300% in Q3 of 2026, 170% in Q4 of 2026, and about 50% in Q1 of 2027. There is a significant Q -by- Q growth in the volumes. We remain focused on building the business country by country rather than extrapolating early growth rates. In the Middle East and Africa, registration in South Africa has been completed. We now have coverage across the GCC markets. Planned launch activity in the region has been affected by the recent regional conflict, and timing of commercial rollout will depend on normalization of conditions in the Middle East.
We continue to engage with potential partners in other markets and are at an advanced stage of discussion for South America, Mexico, Philippines, Thailand, Morocco, and Australia. These agreements will lead to large-scale availability of Exblifep across the globe. We are also in discussion with prospective candidates in U.S. and China. Coming to cefiderocol, the project remains on schedule. Some equipment originally sourced from China had to be rerouted through Italy. While this created execution complexity, it has not changed the overall project timelines. We target commissioning by December 2026, followed by validation and initial batches during January to March 2027 period. Commercial launch will be subject to the approval process from DCGI. Separately, GARDP has floated a global RFP process for broader market access, and once they finalize the distributors in different countries, as you know, 135 countries are entitled to get the product from GARDP.
We hope to start the supplies as per their progress in the agreements. Finally, on the 7-ACA project, our objective remains unchanged: commissioning and the first commercial batch by March of 2027. This is among the largest and most complex fermentation projects being executed in the country. It is a critical backward integration project which can provide the advantage of scale to Orchid, and we are putting our best efforts to execute the project successfully. More broadly, while the first quarter has shown improvement, it would be premature to assume the straight-line recovery. Pricing and demand conditions in our core markets remain competitive and the benefits of merger synergies, product mix improvement, and new projects will emerge progressively rather than all at once.
Our near-term priority is clear: protect and grow the core business with cost discipline, improve margins through volumes and product mix, and execute our capital projects safely and on time. Over the longer term, we remain constructive about the opportunities before us. The combined Orchid- Dhanuka platform, backward integration into 7-ACA, the cefiderocol access project, Exblifep commercialization, and selective expansion into regulated finished dose markets create a more diversified set of value creation opportunities than the company had in the past. However, these opportunities will create value only through consistent execution. We will therefore remain focused on operational discipline, prudent capital allocation, regulatory compliance, timely project delivery, and transparent communication with all the stakeholders. Thank you for your continued trust and support in Orchid Pharma. We now welcome your questions.
Thank you so much, sir. Ladies and gentlemen, we will now begin with the question- and- answer session. Anyone who wishes to ask a question may press star and one on their touch-tone 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 question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question comes from the line of Shashwant Vijay with SIC Wealth Management. Please go ahead.
Hi. Am I audible?
Yes, sir, you are. Please go.
Yeah. Congrats for a good result. I just had two questions. The first it was that, as you said that the industry pricing pressure cycle is still on, I wanted to understand what the management thinking is. Will there be any margin recovery in H2, or will it take more time, or will it go to FY 2028?
See, I believe that in the non-regulated market, the competition will continue, and generally it depends on the cycle of demand. It is very difficult to predict in that area. 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. I would consider this quarter as a mediocre in that terms. We hope in the next two, three quarters, our demand for the regulated products will improve and we can do better performance.
Okay. Another one was that since the Jammu facility of 7-ACA will start in February 2027, I wanted to know what the expected ramp-up curve and utilization trajectory is for that facility, and how much will the output be captive and how much will be a third-party sale?
Hi. Our ramp-up plan is to go to about 80%-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- parties. 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. Our next question comes from the line of Tarun Krishna with iThought PMS. Please go ahead.
Thank you for the opportunity. 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 you can name some of them? Are you expecting them to drastically reduce their prices once your 7-ACA site is fully commissioned?
Yeah. Thanks for your question, Tarun. It is concentrated between three to four companies only. Not too many companies make this product. It is a complicated fermentation synthesis. The second question is with respect to price reduction. Although you cannot predict the Chinese, what I believe is all the companies now want to make profit. It is a different situation compared to what used to be 15- 20 years ago when the state was funding most of the company. Private enterprises want to make profit. The pricing in 7-ACA has been stable over the last 10 - 12 years. The weighted average is about $60. We believe that there is not much room to reduce prices drastically.
Okay, that is helpful. Can you name some of these Chinese companies as well?
There is a company called Sinopharm Weiqida. There is a company called Zhuhai United. Then there is Yili Pharmaceutical.
Okay.
There is a company called Lizhong Pharma.
Okay, got it. Next one on commercializing enmetazobactam. For the countries that you signed the marketing partnerships with, will we be also manufacturing the products for those partners?
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 the CMO in China. So the supplies will start from that CMO itself, but we will have our margin in the supplies. 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, once we are able to register the product from our site, we would be able to supply some percentage from our site. That is our long-term plan.
So currently, w e are not producing enmetazobactam now for the partners. It is fully partners providing-
No, we are producing for our consumption for domestic market. We manufacture supply to Cipla and we sell in our own brand, Orblicef, in India. That is manufactured by us completely.
Okay. All the international sales of enmetazobactam is from the third- party.
Yes.
It will come from our CMO in China to begin with. Slowly we will get registration from our site and partially start to supply from here also.
Okay, understood. The next one on GCLE. Can we talk around where exactly is this product used in our value chain? Will commencement of a 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.
Oh, okay. Got it. Our share of business with Otsuka Chemical has been increasing since the last five years. What would be the reason for this?
I am not really aware. It is—
You are talking about from the related party report. Are you reading from there?
Yes.
Yeah. That is the procurement of GCLE largely that you can see there. It is dependent on the product demand. As we shared last year, the numbers had significantly reduced due to overall demand reduction of 15%-20%. That is why you see a decline in the overall value.
Yeah. Absolute value, yeah. But if I take it as a percentage of our materials cost, that number has been increasing since the last five years. That is the point I am looking at.
I am not sure which number you are 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 could have led to some changes. But as such, in a strategic alignment with Otsuka with respect to GCLE, there is no change.
Okay, understood. That is it from my side. All the best. Thank you.
We procure our 100% GCLE from Otsuka, so the values may change depending on our demand and the pricing part.
Okay. That is helpful. Thank you.
Thank you. Ladies and gentlemen, anyone who wishes to ask a question may press star and one. Our next question comes from the line of Nishita with Sapphire Capital. Please go ahead.
Yes. Hello, am I audible?
Yeah, Nishita.
Yeah. I just wanted to understand, with the new facility coming in, everything, what kind of CapEx have you budgeted for FY 2027?
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.
The entire CapEx would be spent.
Okay. Can you quantify the CapEx?
Yeah. It is already there in the presentation, but INR 750 crore is for the 7-ACA project and $20 million-$25 million, I do not remember the crore amount we have disclosed for the second Irinotecan project.
Okay. I understand. My next question is on, you mentioned that for regulated markets also our demand is cyclical. Can you specify more, like in which quarters do we have more demand? You mentioned that Q1 was mediocre in that sense. If you could say, is H2 better for us in regulated markets?
Yeah. Last Q, we had strain we have seen with the second half is generally having more demand from the regulated. It is probably the winter season there.
Right. Can we expect the Q-o-Q growth to be better than in H2? In Q1 we had a 15% Q-o-Q growth. Can we expect that growth number to be better in H2?
Yeah. We hope to have better sales Q-on-Q this quarter.
Okay. If you could give some sort of guidance by ROI, what sort of growth can we do for 2026-2027? Because we are going to have a Q-o-Q growth, I am assuming 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. That's understood. Thank you so much.
Thank you. Ladies and gentlemen, anyone who wishes to ask a question may press star and one. Our next question comes from the line of Dhwanil Desai with Turtle Capital. Please go ahead.
Hi. Good afternoon, everyone. My first question is on the 7-ACA project, and I think in line with one of the earlier participants. What happened in Pen-G with Aurobindo Pharma, the way China dumped and 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. 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 to a state where the electricity cost is the cheapest in India, so water is abundantly available. The boiler steam cost is lower due to available of abundant agricultural waste. Obviously we are working aggressively towards improving our overall tighter concentration so that our yields can improve. Our pilot plant team is working towards that. I think the best you can do is use all your resources to improve your efficiencies, and that is our target.
When you compare with Pen-G, what happened, Dhwanil, we have talked about earlier in other calls. 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. Because they increased the prices from $10- $12 to $30- $40, 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. Therefore I said I do not 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-PLI level. If you look at the prices of Pen-G, the current prevailing prices are same as they were in 2019 or 2020. 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. They brought it back to the normal level.
Got it.
Like Mridul said earlier also, now these companies are largely privatized, and we do not 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 is the general belief now for the Chinese companies. 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. We have changed, at least I have changed my thinking about the Chinese. If I find that the Chinese selling something cheaper, I would want to believe that their technology is better and I should look at my technology. That is my belief these days.
Got it, sir. Very clear. Sir, second question is I think we have a technology partner and I think they also supply to the Chinese manufacturers. Do we have only the process technology transfer or the strain part also is given by them? Because the high-yielding strain will make a lot of difference in terms of the end competitiveness. 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. They will help us in improving the technology over the years. They have some incentive to give us those improvements.
Okay. Got it. Last question. Sir, with all this in place, typically we have seen that fermentation product takes a longer time to ramp up. Where are we today? When you say commercial batch, I think that would be a very composed part of the ramp-up. Eventually the stabilization will take 12 to 15 months. Is that the timeline that you guys are working with?
We are guiding 12 months, and I have said that again earlier that looking at others' 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 will have to wait to see what actually happens. We have been successfully been able to scale up our existing pilot plant by 20x, and we have to another do about 800x from there to Jammu. But it is a little unpredictable. We still remain hopeful that we will be able to reach full utilization in one year, by the end of one year.
Okay. We will come to know the end output is good in terms of quality and yield, by March, right? That is a fair way to say 20x to 800x that we are talking about, that will happen in February- March of 2027.
Yeah, the first batch. Yes.
The first batch.
Yeah.
Okay. Got it. Very good. Thank you.
Thank you. Our next question comes from the line of Rupesh Tatiya with Long Equity Partners. Please go ahead.
Hi, Manish. Hi, Mridul. First question is, some data you gave on vials. I do not know if it was for enmetazobactam . Could you please just repeat that?
Which one?
Russia.
Yeah, $178 million for Russia. Is that what you are talking about?
No, from vials. You gave some growth data Q2 this much, this many vials.
Sure
Q3 this many vials.
Yeah.
What was that? So that data, if you can repeat.
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 FY 2026, there was a 300% growth Q-o-Q. In Q4 over Q3 it was 170%, and in Q1 FY 2027, there was a further 50% growth over that. As the volumes are increasing, we are seeing this J- curve continue to play out. That is what we were trying to share.
Okay. Has ADVANZ PHARMA launched the product in all the markets where it is registered?
Sorry, ADVANZ PHARMA what?
Western Europe.
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 U.K. They have launched in all of those big five markets and some of the other notary 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 have not made the partnerships to launch yet.
Okay. At what point does this ADVANZ PHARMA stream start becoming 5%- 10% of the revenue? Do you think it is FY 2028, FY 2029?
I would not guide on ADVANZ PHARMA specifically becoming 10% of our revenue, although I would be happy to see that. Our long-term guidance on this is remaining the $1.1 billion - $2 billion that we came up with in 2021. Looking at even the Russia numbers, we remain optimistic that the partners continue to believe that it is 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. It would be difficult to say the answer to your question.
Okay. Russia, what are the timelines for registration and commercial launch?
The agreement is just signed. We announced last month. Since that time, I think registration dossier submission and launch would take about one and a half to two 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.
That we will come to know only after we apply. As you know, there is a SEC committee that sits in DCGI after your application. We are working with GARDP to engage the stakeholders in the usefulness of the product and the strong unmet need in the country. The actual result we will come to know after the application.
Is there any precedent for the waiver?
Sorry?
Is there any precedent where DCGI has granted a waiver in the past?
Yeah. Our cefepime and enmetazobactam itself is a precedent. We got the waiver because the committee thought that 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. This GARDP RFQ, do you need any registrations or regulatory approvals? How does that work for 125 countries? Or just WHO enables you to supply to 125 countries? WHO certification.
Yes. The overall target is getting the WHO PQ. If you get WHO PQ, then the process of registration in many countries becomes very simplified. When the product is distributed by non-profit organizations like CHAI and GARDP, then it becomes further, I would say, faster. 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 two years, around two years.
Around two years. Okay.
Yeah. We are banking on our sales in India. I think that will be our first market.
First market, okay. Any update on U.S. formulation strategy? Any just summary maybe you can give where we are at, where will we go in next three to four quarters?
Yeah. Rupesh, we just talked about that strategy first time last quarter, and the guidance is till 2030. I do not think there will be quarterly updates on that. We will be sharing possibly annual updates on that only. Things will not move much in quarter to quarter.
But have you started looking at the products?
No, the products are already identified and part of our presentation, which products we are going to launch. So it is cefta-avi, ceftaroline, ceftolozane- tazobactam, three 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—
Those will take time.
distributors in the U.S.? Yeah.
Yeah. Those will take time. For the generic molecules, we will be using our cefiderocol facility to file. That will require taking validation batches, USFDA approval, filing, all of that, which will take few years time. For the newer molecules, we will 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.
What was the EBITDA loss for AMS division in quarter one? Where do you see that for the full- year? How is the discussion to get distribution license for cefiderocol?
It was around INR 50 lakhs for this quarter.
Sorry?
About INR 50 lakhs for this quarter. The results were much better than the last quarter.
Okay. If you can share the number also, revenue number from that division.
Yes. It was revenue for AMS was INR 5 crore.
Cefiderocol distribution, whatever process license.
Cefiderocol is—
No, not cefiderocol. The Orblicef and we have couple of other brands that sales through AMS division was around INR 5 crore or so.
Yes. Cefiderocol is not launched.
Yeah, but eventually we are looking to become a distributor of cefiderocol, right?
Yeah.
When we launch, will we be the distributor?
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 come from the line of Nishita with Sapphire Capital. Please go ahead.
Yeah. Thank you for the follow-up question. If you could just reiterate, when are we going to 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 six to nine months from there for cefiderocol approval in India.
Okay.
Depending on DCGI granting the clinical trial date. That would be Q3 of next financial year.
Right. 7-ACA revenue contribution we can see from FY 2028, right?
Correct.
Okay. Thank you so much.
Thank you. Next question come from the line of Ankur Chadha, an Individual Investor. Please go ahead. Ankur, you may please proceed ahead with the question. Thank you.
Hello. Sorry. Just one question. Is there any risk to the PLI benefits due to the slippage in the timeline, or has that matter been settled with the government?
Sorry, can you repeat the question?
PLI. We will probably be entitled for two years. Based on the current scenario, we will be entitled for two years.
Okay. Is there any scope of getting extension on that?
We will maybe try for extension only once the plant gets started.
Okay. Just one more question on this NPNC business, which came from Dhanuka Laboratories. In this quarter, of this INR 350 crore revenue, what was the portion of NPNC business?
We will just come back. We will check and come back. That is a relatively smaller part of the business as of now.
Okay. Thank you. That is it from me.
Thank you.
It is around INR 20 crore-INR 25 crore per quarter. For this particular quarter, we will have to separately check and come back.
Thank you so much, sir. Ladies and gentlemen, anyone who wishes to ask a question may press star and one. Our next question comes from the line of [Prateek Srivastava with Newage 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 the five, six 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 the five to six target products which probably are furthest along in the filing or approval process, sir?
It depends on which market we are talking about. We have recently launched this product called ceftaroline in India, and our brand is called ORTARO. This is a molecule which was only provided by Pfizer, and they are trying to withdraw this product from India because probably their costs manufactured in Europe is not viable. That is one product which we will slowly manufacture and export to other ROW countries. If you are talking about the U.S. market, that is one product, Ceftaroline, which we plan to file ANDA. Of course, Ceftazidime Avibactam combination is another product that we wish to file in the regulated markets. After that in the pipeline is a molecule called Ceftolozane and Tazobactam. That is in our R&D stage at this point of time.
We feel these are a 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 these cef injectables. We feel that will give a significant edge to Orchid in the coming years.
Correct. Thank you, sir. One more question on the enmetazobactam, sir. I think, if I am right, you mentioned that $1 billion-$2 billion lifetime sales potential with peak at around year four to five post-launch. I think we are active in India, but any other markets or regulated markets today we are active with this product? What could be the realistic revenue contribution from this for FY 2027?
No, Prateek, we do not give yearly numbered guidance on this. The $1 billion-$2 billion is lifetime sales, not the fourth year or the fifth sale. Besides India, it is already selling in Europe and GCC is approved, which is the Middle East market, and South Africa is approved. Shortly it would be launched. As 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 geographies. We hope that by end of this financial year, agreements would be in place for three, four more places out of those.
Okay. Thank you. Thank you very much, sir, and all the best for future.
Thank you.
Thank you.
Our next question comes from the line of Vishal Manchanda with Systematix. Please go ahead.
Yeah. Hi. Good evening, sir. Thanks for taking my questions. On 7-ACA, have you seen any material price changes on a quarter-over-quarter basis?
No, it's pretty stable for last one year.
On our final APIs like cefixime, cefuroxime, are they also stable?
Cefixime is the one having maximum pressure. Cefuroxime and other 7-ACA base fortunately seem to be more stable compared to cefixime.
Okay. But on cefixime, would our spreads be narrowing or the spreads remain the same?
Cefixime does not start from 7-ACA. That starts from Pen- G and GCLE only.
Yeah, 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. Is it so for even the regulated markets, or is it only for the rest of the world markets?
It is for the rest of the world market, is where the volumes are huge, and that is where the pressure comes from.
Okay. Anything that we are doing to reduce our dependence on this product since this is Pen-G derived and we are not backward integrated there?
Yeah. 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 business. We are more focused on the value-based business and more of a diversified portfolio. If you see the competitors in cephalosporins right now, we are the only company which can make about 20 to 25 products, whereas the others, they make three or four products and focus on the volume. So our strategy per se, as a cephalosporin player is completely different from our competitors in India.
Okay.
And how it plays out, that is the reason we could see that the generic business of cephalosporin API is going to become a low margin business. That is the reason we sought to go for a backward integration and a forward integration. 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, once you have 7-ACA, ceftriaxone is potentially another large market within the cephalosporin space. Is there an opportunity for us to scale up there and kind of—
Sure
scale up quickly there in a shorter timeframe?
Yeah, that is our plan. 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. 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?
Yeah, absolutely.
Okay. But would you have capacities to sell the sterile version too? Are there 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. You see, 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. There are three, four players, they can take a large part of your volume production. Rather than getting approval process in 200- 300 customers, it is better to collaborate with these four manufacturers of sterile who already have the capacity and who already have worldwide approvals. So I do not see much benefit of competing and creating overcapacity. We would rather collaborate with them.
Understood. Sir, on [ceftazidime avibactam], you had once indicated you have been trying to do a non-infringing route for an early launch in Europe. Is that work under progress and any timelines to that?
Yeah, 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. The U.S. plan, although unfortunately last filing had some objections, we still continue to have plans to refile, and that is going on.
The filing should happen this year in the U.S. for ceftazidime avibactam?
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 Tatiya with Long Equity Partners. Please go ahead.
Yeah, hi. Thank you for follow-up. One question on 7-ACA. There is this, you say, cancellation of VAT refund. Is that applicable for 7-ACA manufacturers also in China?
Sorry, I'm not sure what you're talking about.
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. My question is, were 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. Another question is, what was the sale of NPNC segment in maybe last year or this quarter? Any high-value APIs that we're working on in NPNC?
Yeah. This quarter sales was INR 21 crore, 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 will be this year, next year?
Yeah, I mean, it's a continuous process. You see, in synthetic, you continue to introduce new products. I would not say it's a news that we would want to discuss on a large scale. Yeah. It's an incremental improvement that you continue to do. In Pen-G synthetic, you have to keep working either by increasing capacities 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 to 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.