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Shilpa Medicare Ltd (SHILPAMED) Q1 2026 Earnings Call Transcript

Shilpa Medicare Ltd (NSE: SHILPAMED) Q1 2026 Earnings Call dated Aug. 13, 2025

Corporate Participants:

Unidentified Speaker

Monish ShahHead of Investor Relations

Keshav BhutadaExecutive Director

Alpesh DalalChief Financial Officer

Analysts:

Unidentified Participant

Krisha KansaraAnalyst

Suvaan MittalAnalyst

Sanjay KumarAnalyst

Kiran DAnalyst

Harish BilakhiaAnalyst

GauravAnalyst

Shubham SehgalAnalyst

Presentation:

operator

Ladies and gentlemen, good day and welcome to Shilpa Medicare Limited Q1FY26 earnings conference call. As a reminder, all participants line will be in listen only mode and there will be an opportunity for you to ask question after the presentation concludes. Should you need assistance during this conference call, please signal an operator by pressing Star then zero on your touchstone phone. Please note that this conference has been recorded. I now hand over the conference to Mr. Munish Shah from Shilpa Medicare Limited head of investor Relation and Strategy. Thank you. And over to you sir.

Monish ShahHead of Investor Relations

First Quarter FY26 Results Conference Call we are joined by on the call by Mr. Keshav Butada, Executive Director and CEO of Shilpa Pharma Life Sciences Limited and Mr. Alpesh Dalal, our CFO. Before we begin the call, please note that the financial results and the presentation have been uploaded on the stock exchanges. Note that this call is being recorded and the transcript along with the audio of the same will be made available on the website of the company and the stock exchanges as well. I would like to remind you that today’s discussion might include certain forward looking statements based on the current expectations and assumptions.

These statements are subject to risks and uncertainties that could cause actual results to differ materially. The company undertakes no obligation to publicly update or revise any forward looking statements whether as a result of new information, future events or otherwise. With that I would like to hand the call over to Mr. Keshav for his opening remarks. Thank you. And over to you Keshav.

Keshav BhutadaExecutive Director

Yeah, thank you Mohnish. Good evening everyone. Thank you all for joining our call. We have had an exciting start to the year delivering our highest ever EBITDA in our history. With our relentless focus on monetization of assets, we are confident to continue the momentum in upcoming quarters. Let me start with briefing you each segment wise. My overall briefing will be divided into three main business verticals, API Formulations and Biologics. So let me start with the API business division here. I’m happy to inform you all that for the current quarter we have delivered our highest ever Q1 performance till date, year on year.

Which helps us understand that as a API business segment also we have started focusing now on delivering good numbers. So let me start with the briefing from Oncology segment which is our key major business focus segment in API where we are working currently on the two main NC programs where for the first NC program which we are developing API for our customer, the program which I mentioned last time, also the product already the NC is filed by our customer and we are expecting the commercialization in next financial year. Similarly the second NCA program where again we are delivering API to our customers, the phase three study is ongoing and they are expected to complete by next year.

Apart from that all the generic molecules which are our very strong oncology product pipeline of generic product we have a strong order book in place already and we are confident of delivering good numbers in the upcoming quarters. In the current quarter we even validated two other new oncology products where the product process validation is completed in the current quarter and we will be filing the DMF and CEP next six months with six months stability our captive products where we have developed some non infringing API and wherein our formulation was also developed non infringing, we are doing really good with our captive formulations in the end market and for which the API delivery to our captive is expected to grow quarter on quarter.

Now coming to the non oncology segment with transamic acid capacity expansion which was already completed and the commercial supplies were already started we are seeing that month on one the production capacity is increasing and thereby adding to our sales turnover. Second product which is also Deoxycholic acid where every quarter on quarter our capacity to manufacture and sell is increasing as on date our run rate is Almost more than 10 metric tons per month every month in a quarter. Third product nor OSO Deoxycholic acid which again is an NC molecule which we have API we have developed for our captive formulation.

The API commercial supplies are expected to start from second quarter FY26. Now last mycophenolate mofetil which is again a new non oncology product which we have taken in the grid for that the process validation is completed in the current quarter and we’ll be filing Again DMF and CEP with 6 months stability coming to CDMO peptide and polymer which are very strong growth driving segments for us. Currently in CDMO we have more than 20 active CDMO projects which we are developing for our customers wherein multiple programs are in pre clinical in phase one, phase two Phase three.

In next year we are expecting two CDMO projects to get commercialized for which already our partners have filed the NC from that polymer for polymer segment where last time we have briefed you that we have already received the commercial supply order from our customers. The commercial supplies have already started in Q1 and is expected to complete by Q3 and after the supplies are completed we expect to have a replenishment order so this will be a study business for us. Now for next few years. Second there is one more specialty polymer which we have developed for one more big pharma customer where again the specialty polymer manufacturing and supply is completed in current quarter and thereby they will be using this polymer now in their NC application which will open a good opportunity for the company in years to come.

Now coming to peptides where in the peptide segment three main products which we are working on GLP1 were liraglutide, semaglutide and Tziporatide where company is planning to do both API and formulate API liraglutide. Already now the manufacturing validation batches were completed, 6 months stability is also completed and now our formulation registration batches are completing by end of September. Once that is completed with 6 months stability both API and formulation will be flying in global all markets. Second product Semaglutide where API our development is already completed and we are planning to start the registration batches in Q3F26.

So by end of Q4 we are planning to complete in semaglutide both API and formulation registration bat again which is a very interesting product in the GLP1 space. Our lab development is completed and we will be starting the scale up in Q3 FY26. So I think API as a business division with a mix of oncology, non oncology, cdmo, peptide and polymer. We are positive to have a good growth in the upcoming quarters to come. Now I start briefing about formulation business division where we have had a significant milestone in the current quarter by with the approval of NOR usodeoxycholic acid which is the first NCE which was developed by Philpunk and globally it will be the first country where we will be launching this product which marks a significant footprint of HILPA in launching new chemical entities in market which will be the first of the kind NC new chemical entity program which SILTA has developed and start to end and also will be commercializing.

Apart from that there are totally three NDA products which already are approved in US where our partners are already selling this product and we are expecting a very reasonable contribution from all these three NDA molecules in the current financing year where we will be starting to see the numbers in quarters to come once the reconciliation and profit shares are received. Apart from that Nilotinib which is again our flagship product in Europe currently where we were the first company to launch with a non infringing formulation. The molecule is doing reasonably good and we are expecting we have a very strong order book already in place for upcoming quarters already apart from that our Rotigodine transdermal patch which was already filed in Europe, we are expecting to get approval in Q3 Q4FY26 the same product again for us.

Also our clinical studies are almost completed and we are planning to file the product in US also in Q3 FY26. Apart from that there are four more differentiated assets which we have company is already having in pipeline for which already all the details are provided in the investor presentation. So the main focus in our formulation division will be doing differentiated products and also making products which one or two which will be a new chemical entity which will help us in having sustainable growth every quarter and years to come. Also I’m happy to inform everyone that in the current quarter we have received EIR from US FDA for our transdermal patch manufacturing facility which will open opportunities in the US market also for our transdermal patch facility.

Now I’ll start briefing about Kirpa Biologics sorry the Biologics division. So in Biologics division as we have already publicly announced that the two NC program, Alveolus Bio and Map Tree both the NCE program NBA programs, the company has already entered into agreement and wherein for both the programs we will be doing start to end development and manufacturing. So we are expecting both these NBA programs to enter into the human studies next year which is the most important milestone for us for this nb. Apart from that in Biologics division as on date we are having five active CDMO projects which are running for our customer wherein each program is at a different stages of pre clinical and phase one supply and as and when in the quarters and years to come the program will be advancing, we will see a good revenue trajectory for Sulpa biologics.

Apart from that antibody drug conjugate which is our main focus area going forward we have our first antibody drug conjugate product development already initiated and we are planning to enter into human studies in next year. And on the biosimilars where our Nivolumab which is our flagship product, we will be entering into the human studies by end of this year where the preclinical studies are already completed by us and we have already put the application to start phase 13 human clinical studies, we also have four more biosimilar products already in development where the cell line development is completed.

Apart from that Albumin which is the recombinant human albumin for which we have already signed a partnership deal for Europe market with Odeon for the said product, the tailor batches has already started in the facility and we are planning to start the human studies by end of this year as planned. Apart from that we are also planning to submit our advice in US on our clinical study strategy and we are expecting to have outcome of that in Q4FY26 wherein after that we will be also targeting the US market for albumi and on the excipient market which is a DMF grade market.

We have started sending samples to some of the customers and the initial evaluation at various customers is going up with this. I will be happy to tell everyone that our long term focus is on complex pipeline and also working on NC’s and NBS which will help us in having sustainable and long term growth. Yeah thank you. I think Kalpeji over to you.

Alpesh DalalChief Financial Officer

Yeah thanks Keshav and good evening everyone. Let me briefly take you through the financial performance of the first quarter of current financial year. Our revenues for the quarter were at 328 crores recording a 9% growth year on year and the growth for the quarter was largely driven by growth in API and biologic verticals. Our gross margin for the quarter were at 76% an improvement of 700 basis points compared to last year and this improvement was mainly driven by a better product mix that we have had and as indicated by Keshav, all these measures have resulted into us recording our highest ever EBITDA during the quarter which stood at 98 crores as compared to 83 crores in Q1 of last year showcasing a growth of 18% year on year now and the EBITDA margins thus coming in at 30% now.

Our finance cost for the quarter was 19 crore as compared to 24 crore in Q1 of last year. So you know we have been, you know regularly working on measures to reduce our finance cost. I am also happy to share that as indicated in my earlier communication, we have replaced our remaining high cost NCD of 75 crores with a low cost debt and about 2 days back. So this should help reduce our interest burden even further. And in another development we have recently issued approval from NCLD Bangalore for amalgamation of I and M technologies with Shilpa Medicare and the tax impact of unabsorbed losses of I and M is likely to result in lower tax outflow for the previous financial year and the effect for the same has been captured in the current quarter.

This has also been explained in our notes to the results that have been published. And because of this reduction in the tax component, our effective tax rate for this particular quarter has come down to 5.5% on the segmented performance. Our API revenues on a consolidated basis were 187 crores growing at 8% year on year. And the growth was primarily on account of portfolio rest generation and improved offtake of our key products from the newly expanded capacities. The formulation revenues for the quarter were 98 crores. And the main drivers for the formulation business were the ROW and the European businesses and likewise the biosimilars business recorded a revenue of 73 crores during the quarter.

Let me also give you an overview of some of the balance sheet items. Our net debt was at 550 crores as on 30th of June. And our capex during the quarter was 70 crores. Majorly for our fermentation plant being built at Kathmana Kadachur. Additionally, I’m also happy to inform you that the board at the recently concluded meeting has proposed a bonus issue of 1:1 for the benefit of all the shareholders. With that brief, I would now like to open the floor for Q and A. Thank you.

Questions and Answers:

operator

Thank you very much. We will now begin the question and answer session. Anyone who wishes to ask question may press Star and one on their touchstone telephone. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from the line of Krisha Kansara from Molecule Ventures. Please go ahead.

Krisha Kansara

Hi, Am I audible?

Keshav Bhutada

Yes, we can hear you.

Krisha Kansara

Thank you sir for giving me this opportunity and congratulations on a wonderful set of numbers. My first question is related to albumin and our partnership with Orion. So when Orion released its recent financial report it mentioned that its cash flow also included the signing amount which was paid to Shilpa for the albumin agreement. And the amount in their books was close to 13 million euros. So can we assume that majority of this amount was related to the signing fee which was paid to us by them? This is my first question.

Keshav Bhutada

Sorry, we are under confidentiality with our customer on this product. So as we mentioned before also we are not allowed to disclose any numbers in this. So sorry, I will not be able to tell anything on this.

Krisha Kansara

Okay. But the 57 crore licensing income in this quarter includes the signing amount, right? Received from orientation.

Keshav Bhutada

You can comment.

Alpesh Dalal

So see as Keshav was mentioning, we will not be able to provide the details. The, you know, whatever is recognizable as revenue at this point in time has been has been included in that 57 crores sure, sure.

Krisha Kansara

Okay. My second question is on unicyces contract. Now that there is a delay in this contract because of the issues that are earlier CMO partners, I would like the management to throw some light on how do we plan to move forward with unicisive announcing that it has already found another CMO vendor, how long will it take for the FDA to get back and approve the product? And also assuming this delay, how was our order book impacted? And just some light on this contract will be helpful. Thank you.

Keshav Bhutada

Yeah, sure. So see, I think on unis I save as I mentioned previously, also the financial number per se, the order book and the commercialization, the bigger values were all considered by us in the next financial year only. So there was no major revenues which we were projecting for the current year. Okay. Second part is. Yes, the with our current CMO site where we had issue, we have already done a successful technology transfer in the one more CMO partner which is again USFDAU approved. And from the other facility already the exhibit batches are completed. And with one month stability data already we have submitted this data to Unisign Safety.

So now they will be taking it further with the US fda. Whether the US FDA wants them to wait for six months stability data or with one year stability data they want us to file, that is what they will be checking with FDA which we will be getting to know in the upcoming quarters. But tentatively, what we feel is even if FDA asks them to submit with one year stability data, they will be submitting it in next year. And once that is submitted, we can surely get the commercialization or we can likely get the commercialization in next financial year itself.

Because all the CNC data, clinical data is already reviewed by the agency. So this will be just the additional CMO data which they will be reviewing.

Krisha Kansara

Yeah, it is understood that that was helpful, sir. Thank you for that. And just one more question. So in this presentation, in this quarter’s presentation, you have given the API sales breakup, including captive consumption. Like including captive sales. Would it be possible to give the same breakup excluding the captive sale, just so that we can compare to previous quarters on the same lines?

Keshav Bhutada

Yeah, sure. Alberji, maybe you can tell that.

Alpesh Dalal

Yeah, yeah, we’ll provide that. That should not be a problem.

Krisha Kansara

Okay, and just one, one more question. After the repayment of debt that we announced yesterday, as of now, what is the debt level at the consolidated company level?

Alpesh Dalal

Yeah, no, no. See I. I just mentioned that during my, you know, speech that Debt as on 30th of June was 550 crore. This is only a replacement of high cost debt with a lower cost debt. This is not repayment.

Krisha Kansara

Okay, see the yesterday announcement is related to refinancing is what you’re saying.

Alpesh Dalal

Yeah, it is. It has been. We have repaid that by a lower cost debt.

Krisha Kansara

Okay, thank you.

operator

Thank you. The next question is from the line of Suvan Mittal from mfc. Please go ahead.

Suvaan Mittal

Hello sir, I have two questions lined up. Mainly on the grass margin front. It has increased to 75 to some 69% on a POQ basis. So if you could give some color, that is it because of an increasing consumption, captive consumption of API of the FDA time. What is the percentage of FDs for which the API is, you know, captively consumed and some future outlook on a two tier perspective on do we intend on increasing that and to what level? That’s, that’s the first.

Keshav Bhutada

Yeah, let me take that. See on the API, total revenue, okay. Which is of 227 crores. Right. Of that around 40 odd crore is of captive. Okay. That is what is the captive ballpark number for the current quarter and going forward our API business, we are trying to align more revenues for our captive consumption because that is where our big growth drivers and sustainable growth is possible for this oncology segment. So that will continue to grow. Apart from that, not only that you would have. During my speech I have already told like products like noro sodium acid or nilotinib accitinib.

So all these products, right, where Shilpa is making their own API. For all these launches we will be supplying the API. So captive API consumption is surely expected to grow quarter on quarter. So we are trying to see that API business is very much supportive, hand in hand with our formulation. Okay, so that is first answer on the captive consumption of API to formulation. On the second query, what you had on the gross margin and is it because of our captive API being consumed? No, that is not the right understanding. Our gross margins are mainly improving mainly based on the product mix and also whatever, sometimes whatever profit share, licensing fees, our sales revenue.

So it’s a mix of product mix, licensing fees and sales.

Alpesh Dalal

Yeah. Just to add on to that, you know this margin improvement that has come in, you know, at times in certain quarters you do have, you know, significantly higher margin products going in and all. But obviously you know that’s not something that we would say that, you know, that’s something that as a guidance should continue to be considered and all.

Suvaan Mittal

Okay sir, my second question being you have mentioned that our main Growth did come from biologics and we have grown considerably from 10 crore to 37 crore Q basis. So is it because that the Dalimumab is the main growth driver and if you could quantify on your end that what is the CDMO revenue in that and in terms of the licensing revenue from biologics, do you expect it over a 2, 3 year period to mirror the licensing revenue we have from fdf?

Keshav Bhutada

I think to answer your first question on biologics, why the revenues are higher on this quarter from 10 crores to 37. Right. It’s mainly on the mix of multiple things where our we have also signed some new CDMO deals in the current quarter and apart from that we also have a licensing income which already Alpesh has mentioned which is from our Orion Albumin D. So it’s a mix of revenues which is from albumin and also from our new CDMO contracts and existing CDMO contracts which we have secured. Okay and answering going forward in next one year will it be equivalent to our fdf? See that’s the.

That’s something we will be able to tell you maybe in upcoming quarters to come how the things are progressing in biologics. But as a company as we mentioned, right. We are very much interested to focus on biologics and we are confident that going forward once our molecules like Nivolumab, the ADC program, the NBA programs are progressing well, we are expected to do good in biologics also. Okay.

Suvaan Mittal

So thank you, I’ll join the queue.

Keshav Bhutada

Thank you.

operator

Thank you. Before we take the next question we would like to remind participants. You may press star and one to ask a question. The next question is from the line of from I thought bms. Please go ahead.

Sanjay Kumar

Hi Keshav and team first on Nor udca what is the marketing authorization timeline and what revenue are we Targeting in say FY 26 and 27?

Keshav Bhutada

Yeah, I think it’s a very good question. See first I will tell you Nor UDC is a very significant opportunity for the company wherein why it is so differentiated for us is it’s one of its. One of the kind of molecule approved in India till date which mainly works on liver health activity. Okay. Which directly targets liver health and then thereby cures nafld. Okay. And when the marketing authorization is expected. Marketing authorization from the central is already received. Now we will be going to state authorities and getting the license which is a 15 to 20 days process and then the artwork everything we will be completing.

So tentatively we will be launching it by October. I think October is The right month for us for launching it. Already we have all the launch orders in place for nor UDC and for the said product we have already partnered with the one of the top companies in India, three companies we have partnered and with all three companies we have a licensing income of signing and there are some milestones also which we are expected to get with six months, one year of the sales and apart from that also we will be getting the commercial revenue and how big it will be.

It’s a different experience for us because it is the first NC molecule which Hilpa will be launching in India. So we should see how it will be doing in the quarters to come. But NAFLD is a big disease in India and more than 40% patients in India are going through this disease. So it’s a very large population which will be targeting this product.

Sanjay Kumar

Okay, okay. And second on albumin so has GMP approval? What’s the timeline for the GMP approval for the albumin new plant? Has phase three kicked off? How many patients have we recruited and when can we expect results? And if you can update on what the European and the US FDA have commented on albumin.

Keshav Bhutada

Albumin with the European Agency already our clinical study design we have submitted and we have got alignment on our clinical study. So our phase 3 clinical study as I mentioned previously also we will be starting by end of the year or next year early quarters and all the things are already in place for us. And once the clinical study is starting it will take us maybe 12 to 15 months to complete the study. And after that we will be filing this product after which it is a one year approval process.

Sanjay Kumar

Okay. Will us also be on the same timelines or will us be much later.

Keshav Bhutada

The US we cannot tell you currently because as I mentioned in my speech us our clinical study strategy we are submitting in Q3 and once we have response from the FDA on our clinical Study approval by Q4 we will be able to give you good timelines or clear timelines on us. We are trying to see that if the existing study can be bridged for us also. But we need to see how the agency is accepting it or if they are asking us to do some additional studies. So it all depends on that.

Sanjay Kumar

Okay. And third question on the EU GMP approval for the biosimilar planned, which biosimilar products within our pipeline are you planning to take to EU and if possible us do we can we file phase three for say afibercept or the subsequent products in our pipeline?

Keshav Bhutada

Yes, yes we will be Surely taking our biosimilars to Europe and us. So I feel our first product will be Nevoluma, which already I mentioned. The human studies will be starting by Q4 of this financial year.

Sanjay Kumar

Okay. Okay. So both albumin and biosimilar we can take it global because few quarters ago we weren’t fully convinced of going doing global studies for these products. That standard strategy has changed now.

Keshav Bhutada

See for albumin it was always a global product for biosimilars before we were first trying to do India study and then we were going global. But recently there are a lot of changes in the clinical study requirements globally and there is a good chances that whatever study we will be doing in India with the same study, even Europe will accept that study. So we will be going with the same strategy for Europe and even for us we will be trying it.

Sanjay Kumar

Okay. Okay, final question. One is two products that we have listed as formulation. One is long acting injectable SNL INJ 011 there from the previous quarter PPT the market size has dropped from 930 million to 375. If you can comment on this. And the second one is the last formulation that we have listed, SML OSB 014 which is for anticoagulation segments. Is it targeting apixaban where the patent is expanding 2028 and can we get some sort of exclusivity because this will go through the 505 route or the release mechanism is different. If you can comment on these two formulations it will be very helpful.

Keshav Bhutada

Yes, for SML inj Right. The market size was not dropped only just that what we have tried to do before we were mentioning for various markets apart from the. In the antiemetic space there are totally many products where we can target this product. But now after our study, the way we have designed it, what we have tried to do is mainly on the highly emetic patients. We have tried to segregate that data and that is what we have mentioned in the presentation. So the product, what we have developed is a very specialty product for highly anti emetic patients.

And already as we mentioned, Our clinical study phase 3 in India has been completed and we are expecting to file this product in India in Q4. Sorry, in Q3FY26 and on the second product on SML OSD014. See that’s a differentiated product. It’s currently the name and all we are not able to disclose. But it’s a differentiated opportunity which at the right time we will be able to disclose. But for the same Said product already. The registration batches we have just completed last month.

Sanjay Kumar

Okay. Okay. And what are we doing in semiconductor? I saw that you are participating in semiconductor which is very surprising.

Keshav Bhutada

Yeah, we are not doing anything in semiconductor. It just that we are making some into some chemicals which we feel can go into semiconductors. But this is very early for us to comment because we have just tried to present their understand the market.

Sanjay Kumar

Okay. And one feedback before I joined the queue secret she also had the same question. Most of us would have had the same question after yesterday’s filing. If you could, you know, give a better explanation in all your filings that will be very helpful because from what you filed yesterday the understanding was that you have repaved that ncd. We didn’t know that you only refinanced that cost of debt. So if you could go in forward, if you could have a better explanation on all your findings that will be very helpful. Even your nor UDCA filing we weren’t sure what approval means.

Is it MA approval or is it just product approval? It wasn’t very clear from the filing. So that’s just one feedback.

Keshav Bhutada

Sure. Few feedback. Well taken. Thank you.

operator

Thank you. The next question is from the line of Kiran d from table 3 capital. Please go ahead.

Kiran D

Hi. Thanks for the opportunity and congratulations Shilpa team. I mean one of the most optimistic presentations I’ve seen after a while. So congratulations on the optimistic tone as well. I have a few questions. One on Lenva tenant’s adverse outcome. I mean that we had a month, month and a half ago. Are we challenging? Are we not challenging? Are we still doing at risk launch? Is there something that you can share with us on the adverse outcome please.

Keshav Bhutada

On Lenvat? Anyway, as we mentioned previously also right. Our strategy we will not be able to disclose currently to anyone because that’s purely a market intelligence and our strategy is very different and we will be able to share your right insights at the right time once we have a reasonable outcome.

Kiran D

Got it? Got it. Okay, perfect. Second question is phase three for albumin. You just mentioned that 12 to 15 months from the start and then one year for approval. So we are basically about two and a half to three years in total by the time we gather patients and everything else. So FY29, is that a fair estimate of when we can potentially commercially launch?

Keshav Bhutada

Yes, 28 or 29 should be good time. We have to see it will be Q4, FY28. I think that should be the right time for launch.

Kiran D

And can you tell us a similar.

Keshav Bhutada

Timeline for aplibus phase 3, the aflibercept. As we already mentioned, the phase 3 study, what we are doing currently is for India and Row for which the study is already started. And we are expecting to complete this study in this financial year.

Kiran D

Got it. So commercialization will be next year.

Keshav Bhutada

Yes, next year will be commercial. You’re right.

Kiran D

Got it. Sorry, on the albumin thing, did we already start on phase three or we still gathering patients and getting the stuff from Kadi to client and so on and so forth.

Keshav Bhutada

As I mentioned, the clinical study we will be starting in Q4. I think Q4 FY26 is the short, short timelines where we’ll be starting as on it.

Kiran D

Got it. Got it. Got it. Last question. Formulation FDA approval. Do we have any sense of or did we get a visit from FDA already on the formation plan? Because that can be a big driver given given our pipeline. So this wanted to understand if we have had any indications from FDA as to when they can potentially visit.

Keshav Bhutada

It will be a surprise inspection shortly. We don’t know when they will come but we surely know that they will be coming anytime. Got it.

Kiran D

Got it. Got it. Got it. Got it. Sorry, last one clarification question from Alpesh. The finance expense Q4FY25 was 14 crore. We suddenly jumped to 19 crore in Q1FY26. Is there any particular reason why there’s a QoQ5 crore jump of finance cost?

Alpesh Dalal

Yes, basically we in one of our subsidiaries we have taken an interest swap loan. So it has got converted into a Euro loan. And with appreciation in euro there is. There’s a M2M impact that has come in. Right. So that M2M impact is to the tune of six and half crores. So in reality the cost has actually come down by 1.5 crore. But because of that M2M impact, which is more of a book entry that we have to take, it has jumped to 19 crores.

Kiran D

Got it. So if you go back to normalization, given 550 crore end of June on a steady state basis we are expecting a 14 crore kind of run rate on interest rate.

Alpesh Dalal

We should be able to reduce that a bit with NCD getting replaced.

Kiran D

Got it. Okay. Okay. Sorry Keshav, if I can ask one last question. Nilotinib, Accetinib and rotigotin, maybe Q3 Q4 approval. But from a formulation perspective in export markets, Nilotinib we’ve already launched last year. Accetinib, we I think we launched early April. Is there any other pipeline molecule that we’re going to launch it launch in Europe from a formulation perspective for the next eight months.

Keshav Bhutada

Yes. We have some other products also which we will be launching in eight months time. But at the right time we will be disclosing that. Okay.

Kiran D

Congratulations. Thanks.

Keshav Bhutada

Yeah. Thank you.

operator

Thank you. A reminder to participants. If you wish to ask question you may press star and one on your touchstone phone. The next question is from the line of Suvan Mittal from mfc. Please go ahead.

Suvaan Mittal

My first question being in the previous con call you had suggested that you will be starting to list CDMO revenue from all your articles separately also. So if you could just clarify the CDMO revenue from combined our FDA API and biologics in the Q1.

Keshav Bhutada

Yeah. CDMO revenue for us to report separately for the group. We are still working on it. Because there is lot of consolidation which we need to do on the group level. So we are just working on it. Give us some time. I am sure in the upcoming quarters we at the right time we will be starting to report CDMO separately. Okay, sir. Okay.

Suvaan Mittal

Thank you. That’s it.

Keshav Bhutada

Yeah. Thank you.

operator

Thank you. The next question is from the line of Harish Delakia and individual investor. Please go ahead.

Harish Bilakhia

Yes. Last year comrade entered into agreement with UNISASE from some company for supply of some tablets by June 2025. So I just wanted to know whether company has started activity with unicef.

Keshav Bhutada

No. As we already clarified it for the unicisive opportunity where the commercialization was expected to start this year. Because of the facility issue of our CMO partner, it has been delayed by one year. The commercial revenues will start in next financial year.

Harish Bilakhia

All right, sir. Thank you. Thank you.

operator

Thank you. The next question is from the line of Gaurav from Antique Deep Cohort.

Gaurav

Yeah, Hi. Thank you and good evening. So just taking Q from earlier participant question. Could we quantify the biosimilar sales this quarter and the biologics CDM revenue this quarter.

Keshav Bhutada

Of the total revenue? Right. Our major revenues in biologics today is from CDMO and licensing only. Our major biosimilar revenues will start once we have more products in the market. Especially in Europe and US. Or in the export market.

Gaurav

Okay. So is it fair to assume that the Orion licensing income, if any would be booked in the biologics segment?

Keshav Bhutada

Albeit you can take that answer.

Alpesh Dalal

That’s correct.

Gaurav

Got it. So thank you. Coming to Nor udca. You know, on the go to market strategy now the patient population is huge. But diagnosis is a problem. And we’ve seen another peer with a similar product having Partners for this launch. So would that be a go to market strategy as well? Because our front end is not large so we will be looking for partners and that announcement should be made in the next quarter or two.

Keshav Bhutada

As I mentioned, for the third product already we have partnered with the three big companies in India. In the top 10 companies we are partnered with big three big companies and they will be commercializing this product for us. And also we have kept one license with us also. So totally there will be four people who will be launching it. For the set product from the three league companies whom we have partnered. We have a line licensing income and also there will be a supply sales what we will be securing. We already have launch orders from all the three big companies in place.

Gaurav

Got it sir. Three. Got it, got it. Okay, so last question on the so Pemetric said, you know you’ve been gaining market share. I think profit share is expected in the subsequent quarter. So that’s an upside. Bought a We’ve been in the market for a couple of months. Any indication how the ramp up has been? And you know how soon can we see market share further inching up?

Keshav Bhutada

It will be same like Remy Tech said. So you will see that Botismy also again is a very differentiated product. So this is just very recently we have launched it. So as I already mentioned, right. Even in this year we will see a reasonable contribution from Payment XL and Botismy and it will continue in the upcoming financial year.

Gaurav

Yeah but just a clarification on that. So premature said, you know market share ramp up took almost 10 months since launch. So we can see a similar kind of a, you know, timeline for uptake in Baltic or that could be faster as well given no, we feel it.

Keshav Bhutada

Can be 1/4 early what we feel because we have now some good experience on Premit access. So maybe 1/4 early we will start seeing realization better.

Gaurav

Got it sir. Got it. Thank you. All the best.

Keshav Bhutada

Thank you.

operator

Thank you. The next question is from the line of Kiran B Tabletree Capital. Please go ahead.

Kiran D

Sorry, just a quick clarification. The reason again we have three competitors for Nordhudka and we are very excited about that product launch. So Zaida, does Saro Son Does USO call as what does Udelive So I mean do we. You said there are three partners. Is there any point, at any point you will REVEAL who those three partners are or we should just wait for Q3 launch? Or are these the same partners who already have competitive products in the market?

Keshav Bhutada

We would prefer to wait for 1/4 to disclose because this is all the market intelligence which will help us in getting good market share. So we would wait. We prefer to wait. Okay.

Kiran D

All right. Thanks.

Keshav Bhutada

Yeah, thank you.

operator

Thank you. The next question is from the line of Sanjay Kumar from I thought bms. Please go ahead.

Sanjay Kumar

Hi Keshav. Some follow ups. So you’ve mentioned two NCE projects to commercialize in FY27. This is under the CDMO division. If you can give what product, what indication or the market size for these two products.

Keshav Bhutada

See the one product which we are doing. See both the customer, both the products are for our customers. And the first product which, which the NC is already filed by our US partner. The NCE is for gallbladder indication. Okay. And they have developed a very differentiated product in that for which we will be supplying only one part of the total product which is API. And that commercialization is started next time will be starting next financial year. And the second product is OLC Unic, which already. All the details are available with you.

Sanjay Kumar

Okay. Okay. And what could be the market size for the first gallbladder product?

Keshav Bhutada

That all depends on our partner because they will be the one who will be selling this product. Product. Right. But we feel that it could do good.

Sanjay Kumar

Okay. Second, so I see that at least in my mind we’ll take albumin nor udca sml inj 011 and few of our biosimilars global. That means that we’ll need a lot of CapEx for these global trials. So what CapEx plan do you have for the next two, three years? And how are we going to fund it? Because I was just worried if we’d have to go into another leveraging cycle. Again.

Keshav Bhutada

See as we already mentioned to everyone, right. For all these assets, usually what we are doing now is after one stage we are usually partnering so that we have a partner who is also giving us licensing fees which is further taking care of the cost for our clinical studies. So we don’t foresee any significant change in capex because of this product going into global or going into multiple studies. Because for each of them we will be partnering at the right time when we see there will be a big cash burn for us so that our risk is also hedged.

Sanjay Kumar

Okay. Okay. But CapEx numbers for FY26 and 27.

Keshav Bhutada

On CapEx numbers for FY26and 27, we are working on some CapEx because we want to do some additional CapEx in our API business. So we would be able to finalize that in this quarter. So I think we will be able to give you good picture in next quarterly call. Is it okay?

Sanjay Kumar

Okay. Okay. Sure, sure. All right. And this just an extension to the gallbladder, is the same drug as the FDA breakthrough designation drug that you mentioned.

Keshav Bhutada

Yes, you are right.

Sanjay Kumar

Okay. And any reason for doing bonus? Any particular reason? Issuing bonus.

Alpesh Dalal

So, Sanjay, I think, you know, what we believe is that the way the company is growing, the current equity base is small. There are only, you know, we have got less than 10 crore shares on the market. And the way, you know, the interest in the company has been increasing, whatever we have been, you know, hearing from generally the investors and all, I think improving the liquidity of the stock is an important aspect. So that was one of the driving force. And generally also we felt that, you know, investors who have been with us for a longer period of time, we also need to, you know, in a way, you know, provide them the right kind of benefit.

Sanjay Kumar

Got it. Final question. Since you can’t disclose many things because it’s market intelligence related to products, can you provide an overall guidance on revenue growth for say FY26? And in fact, we should have a separate call for each of our divisions. That’s how complex our business is. So any revenue growth guidance for next two years?

Alpesh Dalal

Generally we do not provide any guidance. But we have indicated, you know, how. What are the drivers for the businesses, you know, for the next couple of years. So that should provide. Provide decent enough and understanding of what kind of growth can be expected. But we don’t provide specific guidance per se.

Sanjay Kumar

All right. Okay. Okay, sir, no issues. All the best. And that’s it for myself.

operator

Thank you. The next question is from the line of Gaurav from Antique. Please go ahead.

Gaurav

Yeah. Hi. Thank you for the follow up, sir, on the novel biologics and the two investments minority that you’ve done in Alveolus and MAP3. We’re expecting them to enter phase one in FY27. Would that entail an additional investment from Shilpa for progressing those trials or an inch up in R and D cost for FY27 for us.

Keshav Bhutada

Because see majorly for both the deals. Right. Our main interest is in developing and manufacturing these assets at our facility for which already all the major infrastructure which is required is already available in Shilita. So there will not be any significant change in our expenditure because of these two programs.

Gaurav

So we would be supplying clinical trial supplies for.

Keshav Bhutada

Yes, phase one.

Gaurav

Got it. Got it.

Keshav Bhutada

For the clinical studies going forward, we will be this exclusive suppliers.

Gaurav

Got it. On the tax rate for the remainder of the Year. How should we look at it? This quarter we had a benefit, but for the remainder of the year, what would be our expected tax rate, please?

Keshav Bhutada

Generally we are in the region of about 35, 36% tax rate.

Gaurav

Okay. Okay, thank you.

Keshav Bhutada

Okay.

operator

Thank you. The next question is from the line of Shubham Segal from Simpl. Please go ahead.

Shubham Sehgal

Hello, I’m audible.

operator

Yes, Are you audible?

Shubham Sehgal

Yeah, I just wanted the latest update. On C of our molecules. So from API like DC molecules, olaparib and teriflunomide.

Keshav Bhutada

In API on Salvo cichlids. As I mentioned, our validation batches are already completed and we will be filing the DMF for this product in next three months time and coming to Olapari for that. The validation batches are already started and we are expecting to complete that by October of this financial year. And after that with six months stability again we will be filing this product and on terriflunamide already the product, our formulation is completed and our API is already commercialized. Okay. Okay.

Shubham Sehgal

And just lastly on peptide, so I think we have these two. One is Desmopressin and the other one is octotide acetate.

Keshav Bhutada

Correct? Yeah, on Desmopressin and Octiodite both the products already are commercialized and we have a strong order book for Desmopressine already for next two quarters.

Shubham Sehgal

Okay, I’m sorry but could you just mention in which regions have we commercialized these two?

Keshav Bhutada

Yeah, mainly we are supplying to some customers in Europe and US and row. So it’s a mix of both where they have started giving us initial quantities of their current for current commercial product. So going forward in next year we expect that value to further increase.

Shubham Sehgal

Okay, okay, got it. And so like a major increase we saw in ROW sales for this quarter. Was it like driven by mainly one. Or two products or was it like. Again a mix of products?

Keshav Bhutada

It’s a mix of multiple products because we have multiple registrations in row which we have done in last three years and now mainly focus as we mentioned to everyone from last many quarterly call site, our main focus is only on monetizing the all work which we have done in last few years. It’s from multiple products. Okay, got it.

Shubham Sehgal

That’s also my side.

Keshav Bhutada

Thank you, thank you.

operator

Thank you ladies and gentlemen. That was the last question for today. I now hand over the conference to Mr. Azbesh for closing comments.

Alpesh Dalal

Thanks buddy. Thank you everyone for taking time to attend the call. We continue to be excited about the path forward and in case you have any queries or any of your questions have remained unanswered. Please reach out to our IR team and we’ll be happy to help you. Thank you.

operator

Thank you. On behalf of Shilpa, Medicare Limited concludes this conference. Thank you for joining us. And you may now disconnect your line.