Ladies and gentlemen, good day, and welcome to the Torrent Pharma Limited Q2 FY 2022 earnings conference call. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded. I now hand the conference over to Mr. Sudhir Menon. Thank you, and over to you, sir.
Thank you. Good evening, everyone, and welcome to quarter two FY 2022 earnings call of Torrent Pharma. Quarter two was driven by a strong momentum in the branded generic market. In terms of financial performance during the quarter, the revenues were INR 2,137 crores, up by 6% on YOY basis. EBITDA was INR 711 crores, up by 11% on YOY basis. The profit before tax was at INR 472 crores, which was up by 23%. Net profits after taxes were at INR 316 crores, up by 2%. Aman, over to you for taking us through the India business performance.
Yeah. Thanks, Sudhir. India revenues at INR 1,087 crores grew by 13% on a year-on-year basis. Underlying growth adjusted for spillover of sales from Q1 to Q2 last year on account of dispatch delays is at 16%. Growth was driven by continued strong momentum across all our key therapies. All our new launches in the Chronic segment continue to gain market share and leadership positions. Patient footfalls have largely normalized now, and we expect double-digit market growth to continue for the quarters. As per AIOCD data, Torrent's Q2 growth was 19% versus the IPM growth of 15%. Torrent is among the fastest growing companies in the CVD, gastro, and CNS therapies during the quarter as per the AIOCD dataset. The PCPM for the quarter was INR 9.9 lakhs with an MR strength of 3,600.
Torrent continues to focus on brand building and specialty approach and has 16 brands in the top 500 of the IPM, with 11 brands with more than INR 100 crore sales. Now over to Mr. Sanjay Gupta for the international business.
Thank you, Aman. Let's start with the branded generics piece. The largest branded generic market outside India is Brazil. Our Q1 sales in Brazil were BRL 109 million. These were up by 20%. The Q2 sales were aided by strong performance of our key brands, new launches, and some price increases. As per IMS, branded generic market growth for the quarter was 10%, and we continue to maintain a strong launch momentum in Brazil, with two launches that took place earlier this year and three additional molecules that should be launched before March 31st, 2022. Moving on to Germany. Our sales in Germany were EUR 29 million, down by 4% on a year-on-year basis.
This growth was impacted negatively due to COVID and new supply delays and channel inventory reduction due to wholesaler customer consolidation. As per secondary sales data, Torrent's growth is in line with market growth. In the U.S., our sales were at $35 million. We're down by 18% on a year-on-year basis and at 2% on a Q on Q basis. Growth continued to be impacted by the lack of new launches, pending re-inspection of facilities and price erosion on the base portfolio. At the quarter end, there were 53 ANDAs pending approval with the U.S. FDA and seven tentative approvals had been received. One ANDA was approved during the quarter. To conclude, sequentially Q2 witnessed steady recovery and normalization across the markets. This was complemented by our strong performance in branded generic markets led by new brands and new launches.
We continue to focus on returning our Germany and U.S. business back to growth. Operator, we can open the call to questions now.
Thank you very much. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their touchtone telephone. If you wish to remove yourselves from the question queue, you may press star and two. Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. Reminder to the participants, anyone who wishes to ask a question may press star and one at this time. First question is from the line of Prakash from Axis Capital. Please go ahead.
Yeah. Hi. Thanks for the opportunity, and good evening to all. My first question is on the gross margins. Since India and Brazil have seen good growth and have a higher share versus last couple of quarters, the gross margin seems to be muted back down versus the last five quarters. Could you explain what's happening here? Are we seeing increase in raw material prices? What is the outlook there?
Oh, absolutely. Prakash, in terms of increase in raw material prices, we are yet to see those things coming in because of, you know, the shortage of power issue in China. There's a general increase, which we have been seeing over the last two quarters. Yes, I mean, there's some amount of increase, but not very significant, I would say. That's point number one. This quarter, what's happened, Prakash, is three factors. One is, you know, if you remember last quarter, we said, the gross margin is looking little lower because, at least in as far as India business is concerned, there's little more concentration of the Acute segment to the overall portfolio. What we're seeing is quarter two, that's still continuing, Prakash.
Possibly, one quarter down the line or maybe in quarter three, we should see that correcting and the mix changing more favorably towards the Chronic portfolio. That's number two. Number three, this quarter there's a higher inventory provisioning, which we've done more for the generic markets, I would say. That impact is roughly 0.5%. That's something additional which has swapped in this quarter versus quarter one. We've seen some amount of higher price erosion in the U.S. business in quarter two versus quarter one. That's impacting the margin by around 0.3%. All in all, we see a impact of roughly 1%, of which U.S. price erosion is 0.30%.
The other two factors which I spoke about, I think going forward, it should get, I mean, it should start reversing now.
Net-net we would be around this level of 72-72.5?
Yeah, I see. I think it should be a little higher than this, because of two factors, right? I mean, inventory provisioning, as I said, is impacting the margin by 0.5% in quarter two. That should reverse in coming quarters, is what I believe. Plus, as I said, you know, the concentration of the portfolio more as far as India is concerned, on the Acute side, that should start getting corrected because I think even the Acute and Sub-chronic segment have started normalizing now. Maybe two months, three months down the line, we should see that correcting and the portfolio mix again realigning towards, you know, our Chronic portfolio. That should be maybe another 0.2%-0.3%.
That's the correction which I believe should happen in the coming quarters.
Okay, understood. Secondly, on the cash flow position, so could you help us understand the cash flow from operations? I'm looking at the number which you have given in your cash flow statement. If you could just, you know, confirm the numbers please.
Net cash from operating activities for the half year ended 30th September , 2021 is INR 904 crore.
This is cash flow from operations?
Correct. Minus the CapEx INR 127, free cash flows would be roughly INR 770 crores.
How much is the net debt now with this kind of cash generation? How much you have paid?
We've repaid around INR 490 crores up till now. Possibly in next two, I think we should be around the same number. Therefore net-net, I think, we should be the net borrowing. Net borrowing should be at roughly I think by year-end, Prakash, borrowing 2,394 plus 1,944, so around INR 4,200 crores will be gross borrowing, Prakash.
Yeah. The net would be?
Net would be minus-
Around 3,600?
Yeah, -INR 700, I would say. Yeah, around INR 3,500 kind of a number.
Perfect. Okay. Last one on the payables side, it seems to have, you know, decreased quite a bit. Any particular reason? I mean, while your inventory and receivables are similar, but your payables have gone down sharply. Any particular reason there?
Prakash, one of the major component in trade payables is the discount claims which Germany-
Germany?
Germany is a tender market, right? There are insurance discounts which come from the insurance company. Previously it used to come with a lag of six to seven months. There are two things which has happened in Germany. One is Germany the growth we are seeing a de-growth, right, in quarter two. That's point number one. Because of which the amount of payables towards the insurance discount has gone down. The other thing is there's some amount of acceleration we see in terms of the discount claims coming from insurance companies.
Excuse me. Sorry to interrupt you, sir. The audio is slightly breaking from your line. Please check.
Yeah, Prakash, you can hear me?
Yeah. I mean, little bit, the sound quality is bad, but it's okay.
Yeah. What I was saying is the second factor, Prakash, is that previously we used to get claims from the insurance companies with a gap of six to seven months. There was a float which was available. Now there's two to three months of acceleration which we are seeing in terms of the claims. That has caused a reduction in trade payables.
Okay. Okay. Perfect. Thank you.
Thank you. The next question is from the line of Aditya Khemka from InCred Financial Services. Please go ahead.
Yeah, thanks for the opportunity. Sudhir, sir, can you break up the India business growth into new products, volume and price, please?
Yeah. Aman, you want to take that?
Yeah, yeah, I'll take that. Volume growth was 7%, price growth was 8% and new product growth was 4%.
7%, 8% and 4%. Okay. Aman, you know, previously we had seen much higher price growth and lower volume growth last year. This year the trend seems to be sort of reversed, where the volume growth is higher and the price growth is lower. I can understand the higher volume growth given last year's COVID impact must have been there across the portfolio. I am failing to comprehend the lower price growth. Can you help us understand that?
The lower price growth, I don't think, it's lower than the last few quarters. It's remained in this range of 7%-8%. This quarter it's 8% as well.
Oh, okay. Sorry. I misheard you. Okay, so 8% is the price growth. Okay, fine. Aman, any color on the-
Which is the-
Understood. Yes.
There's been a lot of yeah.
Yeah. Yeah. I got that. On the generics business that we have started, the trade generic business, I know it's early days, but any colors on how the market is turning out to be? As you're testing waters, how easy or difficult is it to build a business out?
I would say it's a pretty good start. As you mentioned, it's been this second quarter. We have essentially taken some of our branded generic brands and shifted them to the trade generic basket and also added new launches here. The traction is picking up month by month. Probably the next quarter we can give a much clearer picture on what we anticipate this business to look like in the near term.
Understood. Could you also give us some color on the number of MRs? Because you shifted some of these brands from branded generics to trade, were you able to reduce the field force by a little bit? What is the organic attrition in the field force?
No, we have not shifted any MRs. The MR strength remaining exactly the same. At least only mid single digits.
Mid single digits. That is for Torrent's, right? What is standard, industry standard right now in your understanding?
More than 10% is usually the average. 10%-15%.
10%-15%. Oh, so that's phenomenally good. Okay. One last question. Sudhir, on the CapEx plan, what's our CapEx plan for FY 2022 and 2023, and where is that directed, majority of it?
It should be basically maintenance CapEx between INR 250-INR 300.
Understood. INR 250-INR 300, and all of it maintenance, right?
Yeah, most of it. I mean, there will be some expansion which may start next year, end of next year. Basically, for expanding the domestic capacity. But that will be over a period of three years. I would say both put together would be roughly INR 250 crore-INR 300 crore in FY 2022. Possibly FY 2023, we can look at between INR 300 crore to-
No, I got that. Just one last question. Sorry. On the increase in raw material prices that, you know, you alluded to in the previous comment, obviously a lot of this has been driven by China and the supply situation that exists there. Any thoughts on vertically integrating, or do you think the Chinese, you know, raw material price inflation is transitory and, you know, it would normalize in a few months or quarters?
No. From a priority perspective, Aditya, there is no plan to invest in vertical integration as of now.
The price inflation, therefore, how do you tackle that?
No, that's what I said, right? I mean, Aditya, it's too early for me to comment on the price increases which are being talked in the market, right? At least for our portfolio, we've not seen that kind of a major impact coming in. Yes, I mean, if there is an impact coming in, we believe it won't be on the overall portfolio. Maybe in some products it might come in and we'll have to tackle it through price increases, right? I mean, in those specific products within the regulatory allowed framework.
Gotcha. Thanks, Aman, for answering the questions. All the best.
Thank you. The next question is from the line of Damayanti Kerai from HSBC. Please go ahead.
Hi. Thank you for the opportunity. My first question is regarding your U.S. business. Sir, any update on FDA inspection of our facilities? Any timeline which you might foresee at this point of time? In the U.S.-based business, what kind of price erosion you are facing, and where do you see price erosion moving in next, say, few quarters?
On the first question in terms of inspections, we feel that, you know, the FDA started again making inspections in India. We've seen quite a few of our peer companies getting inspected, and they've established a priority list as per what they consider to be important for the U.S. drug supply. We expect them to visit us in the coming months, but I cannot give a firm timetable. It should be, I mean, hopefully in the next, let's say, three months, anytime, and we are prepared for it. In terms of price erosion, we are seeing a pretty high level of price erosion in the U.S. again. There is a lot of competitive intensity that has heated up.
For a base business, it's again safe to assume high single-digit, almost double-digit price erosion.
Okay. Any outlook on the pricing or it largely depends on new launches once we get the facility clearance there?
I'm sorry, can you repeat the question?
Sir, I was asking how do you see this price erosion to set out in next few quarters? Or do you think it will be mostly normalizing once we get new approvals coming from the plants after the clearance?
Price reduction is a kind of a intrinsic part of the U.S. business on the base business. Generally it used to be 3%-5% and it's currently running at a higher rate. Eventually, you know, it should stabilize at the historical trend level, which is between 3%-5%. To grow the business, one has to launch new products. Here's where we've been constrained since March 2019 because we've not got any material approvals. Once the facilities are cleared, we have about 55 NDAs pending at the FDA, so we would expect them to be approved rapidly.
Many of them would still have commercial value on the market and, you know, customers would be interested in sourcing them from us. We are doing that evaluation permanently. We would be bringing quite a few of these to the market. That would have a positive impact.
Okay. Have you started supplies from Levittown facility?
Levittown will have some sales this quarter, current quarter.
Okay. It will start this quarter.
Yeah.
Third quarter. Yes. Okay. My final question is on India business. How do you see impact of this, I'll say pick up in online pharmacies in broader market in medium to long term, especially for company like Torrent, which is chronic heavy. What we understand online pharmacies are now more focused on capturing the chronic part of the market. Any thoughts here, sir?
Same, I believe, dynamic in the market continues. There's no real impact on the branded generic business at all right now. In fact, this could be a good opportunity for us to leverage for the trade generics as we think of changing the online pharmacies.
Okay. No impact as of now, but anything you foresee for the long term?
Nothing significant.
Okay. Thank you. I'll get back in the queue.
Thank you. The next question is from the line of Anubhav Aggarwal from Credit Suisse. Please go ahead.
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The current participant has placed the call on hold. We'll move on to the next question from the line of Pratik Mhatre from Nomura. Please go ahead.
Thank you for the opportunity. Sir, I had a question on the Germany. You had mentioned in the press release that there are some impact due to customer consolidation taking place. So this impact is just on the, like, Torrent, or this is a market-wide phenomenon. By when do we expect this to basically normalize?
Sudhir, are you there?
Hello. Yeah, I'm there. What I was mentioning is that Germany had four major wholesalers, and two of them merged in this year. What they've done is, they're streamlining their inventories. It's a one-time impact whereby, you know, as they consolidate, they bring down the overall level of inventory of the combined group. That is one factor. The second factor is that, you know, the wholesalers have built up inventory in the COVID days, and that's also getting normalized. Both of these, the impact should fade away with time.
Do we expect any pricing pressure in Germany, like, four are now two are merged, so will this give them more pricing power?
No. Actually, the wholesalers in Germany do not really impact the pricing. The pricing is more as linked to the companies that bid on tenders. In general, there are more companies coming to Germany from India and elsewhere, so the pricing tends to build up in the tender process. Wholesalers are more like service providers, and they are the ones that are actually servicing the requirements of the pharmacies. The demand generation comes because of the tenders and so I do not expect the consolidation to yield to result in any additional pricing pressure.
Okay. Okay, thanks. One question on U.S. Sir, in your press release you have mentioned the constant currency sales to be $35 million and in INR 284 crores. That points to a fairly high rate of USD INR, about 81.1. Can you please help me understand, like, why is it so?
Sudhir, can you expound it?
No. Let's come back to you, please.
Okay. Sure. Thank you, sir.
$35 million is the right number.
Okay. Like, is the INR number? Does that contain something else as well?
That I'll have to check. Possibly it's a mistake, but I'll have to check.
Sure, sir. Thank you. That's all from my side.
Thank you. The next question is from the line of Abdulkader Puranwala from Elara Capital. Please go ahead.
Yeah. Hi. Thank you for the opportunity. Two questions from my end. First on the India business. Last quarter we spoke about venturing into the trade generic business. You know, have you already started that? And whether this growth what you have seen in India is that also being driven because of venturing into the trade generic segment?
We have started it, and this is the second quarter of launch. It's a pretty small part of the business, something between 1.5%-2% overall right now, the trade generics business.
Okay. Cool. Thanks. Next question is on the R&D spending, what we are doing. On a quarter basis, this quarter we spent close to INR 130 crore on R&D. When I looked at the U.S. filings, you know, not much of the products have been filed. You know, how is our product filing strategy going to be? Are we going to wait till the FDA clears the site and post that all the products will be filed or, you know, what exactly would be the planning on the product filing part?
There is no change in the filing strategy. Generally we file more products in Q3 and Q4. This year also we expect to file double-digit products in the U.S. No change there. It's just a timing issue.
All right, sir. That would be all from me. Thank you.
Thank you. The next question is from the line of Shyam Srinivasan from Goldman Sachs. Please go ahead.
Yeah. Hi, good evening, and thank you for taking my question. Just the first one is on the EBITDA margins. We have seen a softness in gross margins, which you explained, and maybe you have also given an outlook. EBITDA margins have done better like YOY. Just want to understand what are the levers that are there and if you can help us with some kind of a directional guidance on EBITDA margins as well.
Oh, Shyam, as per the policy, we don't give future-looking guidance.
Sure.
Quarter one, what we had said is, on the expenses, we said, you know, more or less, it should be around this number. In quarter two, if you see, it's that's the way it got delivered, right? What I had also commented last quarter is, maybe the expenses will go up to a certain amount, and that's exactly what we are seeing in quarter two. Other than that, as you said, I've already explained what is that impact on gross margins. I would leave it to you to assume what's there in H2.
Yeah. No, Sudhir, I think only point is, you know, these margins are significantly higher than what we saw pre-COVID.
Right.
From a sustainability, just want to understand, and we have always thought that costs may not have come back fully. When do you think the costs will come back fully? Is it Q3, Q4, or is it only next year?
No, that's what Aman had explained last quarter that most of the pre-COVID costs have come back.
Mm.
If you look at it from a last year versus this year perspective, this year I think most of the costs have come back. Now, the question is, I mean, how does one look at this cost going forward? I mean, in terms of making incremental investment for higher growth or so, that'll be something different. As far as the costs are concerned, I think quarter one, quarter two, we've delivered, I mean, more or less similar kind of a cost, right? And I think the field working, doctor meetings and all have come to almost 95% of the pre-COVID levels. That speaks out on the cost.
Got it. That's very helpful.
I think so going from here in Q3, you know, there could be some just a marginal level of increase in further physical activity, but this may go back to almost maybe 100% level of previous, but again, not too much higher from there.
Got it. My second question, just looking at your MR productivity now almost touching INR 10 lakh, right? At least in this quarter. You know, how should we look at it? You are now almost in line with some of the top players in, [Indian pharma,] which have a higher chronic element like you do. How should we look at this? Do you think, is there any scope required for increasing field force or you think productivity improvements can drive top line growth for us in India?
We in the earlier discussions in quarters have also always been that as our portfolio expands, we will need to add the field force accordingly. When the new launches start coming in, and that's when the additional expansion would be required.
Do you think it's a fiscal 2023 event now, or I just want to understand that?
Yeah, within the next year could be likely, yeah.
Got it. Thank you and all the best.
Thank you. The next question is from the line of Bharat Celly from Equirus Securities. Please go ahead.
Yeah. Hi. Thanks a lot. Check line. Good evening, everyone. Sudhir, just wanted to understand on the German market, given that Germany's overall EBITDA margins are already lower on a lower end and their insurance claims actually accelerating. Are we looking at a dip or a perpetual dip in ROICs for this group?
No, no, not really. I mean, Germany for me, I think, the return on capital employed is superb, because of this float which is available to me, I have a negative working capital.
Right, sir. Since it is getting accelerated, will it impact in the longer period?
I mean, I would say this was something which was expected, I mean, so from a six months or seven months coming down to five months, it doesn't change the color too much. I think still I would say in terms of the returns, Germany still stands out against the other geographies, I would say.
Do you foresee it to get further accelerated in the coming period or you see it will stabilize a bit now?
No, I don't think so. Because I think this whole thing is the thing started when this happened last year, right?
Probably, you know, everywhere there were cash flow pressures which could have been the case with insurance companies also, right, and which made them accelerate some part of it, right. I mean, that's how the system works. I don't think there's more acceleration beyond what's already seen now.
Right. Sir, on the U.S. market, is there any particular set of products where you are seeing higher price erosion or it is a broad-based price erosion which are you seeing this?
Essentially, you know, we, since we don't have new launches, we have legacy products which were launched before 2019. These are some high volume oral solids. You're seeing a price erosion on oral solids as well as a few Derma products that we've launched.
Okay. It is more broad, a broad-based price range which are in the market. Thanks, bye. Hello. Hello.
Yeah. Sanjay, you there?
Yeah.
Yeah.
Okay. Sir, on final one. We have settled for Revlimid, as far as we can see in the court document. Are we going to be among first or second wave of launch? If you could give some outlook on generic Revlimid.
I'm sorry, I didn't understand the question. Can you just repeat again, please?
In court documents it seems that we have settled for lenalidomide, that is Revlimid. When can we expect a launch? And are we going to be in the first wave or second wave? If you could give any outlook, broad-based or a third-party number of it.
Yeah, yeah. No, we settled the lenalidomide litigation.
Yeah, yeah.
Unfortunately, not at the liberty to disclose, as to what the terms of the settlement are.
Sir, can you at least tell whether it is going to be second wave or third wave of launch? Anything broadly you could tell, sir.
No, I think we are driven by confidentiality. Yeah, we cannot discuss that.
Sure, sir. Sure. Thank you. Thanks for taking my question.
Thank you. The next question is from the line of Sayantan Maji from Credit Suisse. Please go ahead.
Thank you for taking my question. My first question is on Brazil. We had a constant currency growth of 18% during this quarter. How, you know, how much is price increase in this? What's the component of price increase?
Broadly speaking, about half of it comes from volume increase. The other half is equally split between new launches and pricing.
Okay, thank you. Second question is on R&D. You know, Indrad plants have not been cleared for the past two years now. Once the plants are cleared, would we see an increase in the R&D spends or, you know, is it not, say, related to this event?
There's no change in our R&D guidance. Generally we guide towards 6%-7% of top line revenue in R&D. We don't anticipate a change in that.
Okay. Thank you. That's all from my side.
Thank you. Participants, to ask a question you may press star and one. The next question is from the line of Pratik Mhatre from Nomura. Please go ahead.
Sir, on the inventory days, I see that the inventory days went up during the COVID period, like during the last year. It is still at elevated levels from the historical levels. Do we expect it to go back to historical levels or do we expect it to remain around these levels, sir?
No, that's what we said, right? I mean it'll start getting normalized over four quarters. Quarter one, quarter two, we've already seen that normalization starting off. I think that should be visible in the cash flow statement. If you look at inventory, there's normalization which has already started. Probably over the next two quarters also, the normalization you'll see happening faster, I would say.
Okay. Thank you.
Thank you. Participants, to ask a question, you may press star and one. The next question is from the line of Amey Chalke from Haitong Securities. Please go ahead.
Thank you for taking my question. I just have one question to ask. Largely, Torrent has oral solid portfolio both in the domestic also in the export market. Is there any plan to expand our manufacturing base towards injectables? And also, if we can talk about the biosimilar plans as well, if there any. Thank you so much.
Sanjay, you want to take that?
You know, we are not into the hospital market traditionally in India and around the world. We currently have set up a plan to do oral oncology drugs. We don't have any manufacturing infrastructure in injectables. But it's always under evaluation, right? We keep studying the markets, keep trying to see what the opportunities are, what our peer groups are doing. Both injectables and biosimilars are areas of constant study at Torrent. But beyond that, I wouldn't like to say whether we are making any investment plans at this point in these two areas. But both of these areas are followed closely by our management.
Just a follow-up question on this. Do you think that not investing in these areas will have any impact on the growth side for us? Or you think we have good enough portfolio even to support with the oral solids?
We are a little bit beyond oral solids already. Especially if you focus on the dosage forms that we manufacture for the U.S. market. In addition to oral solid, we have creams, ointments, suppositories, liquids, suspensions. Now we have oral oncology drugs. We diversified our portfolio, and we have also three 505(b)(2)s in our portfolio. We are doing a variety of things, and we made some choices. You know, one of the choices is we don't do respiratory, we don't do injectables right now for the U.S. market. Those choices are constantly being evaluated.
I'm not saying we will not do injectables because, you know, the customer consolidation in the U.S., it's, there's a lot of pressure in the retail side, where there are only three or four customers which account for 90%. By adding a hospital channel, we would be doubling the number of customers because the hospital side has three to four GPOs, which play an important role in that market. We are interested in going into the hospital segment because it helps us diversify our customer base. But so far, you know, we've not disclosed any products to do that diversification. It's something which is under constant evaluation.
Sure. Thank you for taking my question. Thanks. Thanks a lot.
Thank you.
Thank you. The next question is from the line of Rishi from HNI Limited. Please go ahead.
Hello, can you hear me?
Yes.
Many thanks for the opportunity, sir. Sir, in the last AGM, you have the chairman and the CEO has announced that the outlook looks very bullish, and the pipeline is great. But that has not been displayed in this quarter number. What went wrong in the exports market? What are the challenges in the local market right now in the post-COVID scenario? If you can explain that in a broader term, that would be great.
Hello. Sudhir, you want me to answer?
Yeah, yeah.
Essentially, you know, the big barrier we face is lack of new approvals. While we've been investing in the portfolio and filing the ANDAs in the U.S. market, we have not been receiving approvals because of the status of the facilities, right? That is the number one reason for us to hold back in revenue growth linked to new products. That is. I hope that is an adequate response to your question or are you looking for something else?
Oh. No. What is the outlook for H2? We don't see any signs of the COVID. You know, some of the companies who are our smaller peers have done relatively very well in terms of top-line growth where we are lacking right now. What is the outlook, sir? Can you tell us the outlook for H2, basically? Some guidelines that you can give.
No, because outlook will depend upon the status of the U.S. FDA inspection and the launch of new products, right? I have mentioned that the U.S. FDA is currently inspecting other facilities in India, and they've restarted. We would expect this to happen in the next three months. If that takes place, we will be back on the growth track because our new products will get approved.
Okay, thanks. That's it. That's it from my side. I will send the questions to the company secretary.
Sure. Thank you.
Thank you. Participants, to ask a question, you may press star and one. Reminder to the participants, anyone who wishes to ask a question may press star and one. The next question is from the line of Sayantan Maji from Credit Suisse. Please go ahead.
Thanks for the follow-up. I have two questions. One is on Germany. In last quarter on this call, we had mentioned that, you know, we would be growing in high single digits. Do we still maintain the guidance given the changed landscape now?
Our expectation was that we will be back to the growth track. Unfortunately, this quarter again, there have been a few setbacks. You know, our objective is to grow somewhere between 5%-10%. Historically, that has been the growth rate in Germany. At this point, I would not like to give forward-looking guidance. We are doing our best to remediate the situation and to get back on growth. Some of these are one-time items. I think, at this point I would say that you know, the objective of the company remains to get back to where it was. Hopefully, we'll be there soon.
I don't know, sir, I prefer not to give you guidance for the future.
Okay, sure. For U.S., you know, we were supposed to launch one sartan. Have we done that and is it now reflecting in the quarter sales?
Can you repeat that, please?
in the U.S., we're planning to launch one sartan in this 2Q. You know, have we launched that and is it now reflecting the U.S. sales or are we getting-
It's about sartan. We actually relaunched the older sartan, one of the older sartans in the U.S., and it is reflected in the numbers.
Okay. Finally, just want to check what's the status of the clinical trial of Daxon? Are we done with the clinical trial because I think we got you know tentative. We already have tentative approval on this product.
Correct. We do have tentative approval, and we are in negotiations with the FDA to get final approval. You know, we've met all the requirements and we hopefully and you know, we have a kind of ongoing legal battle in the courts. It's a combination between what happens at the courts and what happens with the FDA. Hopefully, you know, we would see some good results on both of those fronts.
Okay, thanks.
Thank you. As there are no further questions, I would now like to hand the conference over to Mr. Sudhir Menon for closing comments. Thank you, and over to you, sir.
Yeah. Thank you everyone for joining Torrent quarter two earnings call. If you have any further questions, please feel free to get in touch with us. Thank you.
Thank you. Ladies and gentlemen, on behalf of Torrent Pharma Limited, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.