A very good morning and good evening to all of you. Thank you for joining us today for the Dr. Reddy's earnings conference call for the quarter ended December 31, 2020. Earlier during the day, we have released our results. The same are also posted on our website. This call is being recorded. The playback and transcripts will be made available on our website soon. All the discussions and analysis of this call will be based on the IFRS consolidated financial statements.
To discuss the business performance and outlook, we have the leadership team of Dr. Reddy's comprising Mr. Erez Israeli , our CEO, Mr. Parag Agarwal, our CFO, and the investor relations team. Please note that today's call is a copyrighted material of Dr. Reddy's and cannot be rebroadcasted or attributed in press or media outlets without the company's express consent.
Before I proceed with the call, I would like to remind everyone that the safe harbor contained in today's press release also pertains to this conference call. I hand over the call to Mr. Parag Agarwal. Over to you, sir.
Thank you, Amit. Greetings to everyone. I hope all of you and your families are keeping safe and healthy. I'm pleased to take you through our financial results for the quarter three of fiscal 2021. We had yet another quarter of good performance in terms of revenue growth and EBITDA margin, though the profits were impacted by impairment charge taken during the quarter.
Let me take you through these in a bit more detail. For this section, all the amounts are translated into U.S. dollars at a convenient translation rate of INR 73.01, which is the rate as of 31st December 2020. Consolidated revenues for the quarter stood at INR 4,930 crores, that is $675 million, and grew by 12% on a year-on-year basis. Growth is primarily on account of new product launches across markets.
Our North American generics business grew by 9%, Europe business by 34%, India by 26%, emerging markets by 5%, and PSAI by 1%. Sequentially, our revenues grew by 1%, supported by volume pick-up in India, emerging markets and Europe, impacted by price erosion in North American business and lower volumes in the PSAI business. During the quarter, we recognized milestone receipt towards AUR-102, one of the programs of our Aurigene discovery business.
Consolidated gross margin for this quarter has been 53.8%, a decline of 30 basis points year-on-year and 10 basis points on quarter-on-quarter basis. The decline is primarily on account of price erosion and lower export benefits, however, supported by milestone income received towards AUR-102 compound and productivity improvement. Gross margin for the global generics and PSAI businesses were at 57.6% and 25.3% respectively for the quarter. The SG&A spend for the quarter is INR 1,439 crores, that is $197 million, an increase of 14% year-on-year and an increase of 10% quarter-on-quarter.
The increase in expenses is due to investments made in sales and marketing in branded markets, digital capability building, higher freight costs, and certain one-time expenses pertaining to this quarter. SG&A as a percentage of sales was 29.2%, which is within our normal range.
The R&D spend for the quarter is INR 411 crores, that is $56 million, and is at 8.3% of sales. The product development activities continued normally during the quarter, including development of COVID-19 related products. The EBITDA for the quarter is INR 1,185 crores, that is $162 million. EBITDA margin is at 24% and is closely tracking our aspirational target of 25%. In this quarter, we have taken an impairment charge of INR 597 crores, that is $82 million.
The impairment has been taken primarily on three products related intangibles acquired from Teva in the year 2016. These are for the NuvaRing, Santen , and topiramate and saxagliptin and metformin. We do a quarterly impairment testing analysis and as part of it, we concluded that the carrying value of certain of our intangible assets are not reflected of the current market reality. Hence, in line with the requirements of the accounting standards, we took this charge.
Consequently, our profit before tax for the quarter stood at INR 284 crores, that is $39 million. Effective tax rate for the quarter has been 93%, higher due to non-recognition of deferred tax asset on losses arising out of impairment. We expect our normal ETR to be around 25% before the impact of impairment charges. Profit after tax for the quarter stood at INR 20 crores, that is $3 million.
Reported EPS for the quarter is INR 1.19. Operating working capital increased by approximately INR 600 crores, which is $82 million. There has been an increase of approximately INR 300 crores each in the receivables and the inventory. Increase in receivables was partially due to reduction in discounting of receivables, and the balance is in line with the normal business trend.
Increase in inventory was due to a planned increase in inventory for certain products to deal with any potential supply disruptions. We invested INR 287 crores, which is $39 million, towards capital investment in this quarter. The free cash flow was a net outflow of INR 68 crores, which is $8 million, after payouts for the brands acquired from Glenmark for the Russia and CIS markets. We had a net cash surplus as on 31st December 2020 of INR 84 crores, that is $11 million.
Foreign currency cash flow hedges for the next 15 months in the form of derivatives for U.S. dollar are approximately $535 million, largely hedged around the range of INR 74.5-INR 77.6 to a dollar. In addition, we have cash flow hedges of RUB 555 million at the rate of INR 1.0021 to the ruble, maturing over the next 15 months. With this, I now request Erez to take through the key business highlights. Over to you, Erez.
Thank you, Parag. Good morning and good evening to everyone. Hope you are having a happy, safe, and healthy beginning of the new year. The year of 2021 has started with a hope and visibility around life returning to normal after a significant healthcare crisis and socioeconomic disruption caused by COVID-19 in 2020. The vaccinations program has started in several countries, and we are continuing to contribute our bit in this fight against the global pandemic.
Recently, after the approval from DCGI, we have initiated the phase III clinical trials of Sputnik Light vaccine in India. The vaccine's efficacy is confirmed at 91.4% based on the data analysis of the final control points of clinical trials arm in Russia. We have also strengthened our partnership with RDIF and have been confirmed as the preferred marketing partner to enable the safe and expeditious distribution of the vaccine in India.
During this quarter, we continued in our growth journey and achieved higher ever quarterly sales, healthy EBITDA margins, and once again turned net cash positive as of December 2020. We saw a healthy growth across our branded markets in Europe. While the market demand in India, Russia, and other branded markets has witnessed sequential improvements over the last couple of quarters, it is yet to recover to pre-COVID levels.
We continue to progress well on our strategy of diversified business model and creating the right levers of growth for each one of our businesses. This includes building a healthy product pipeline, focus on productivity, improvement in marketing capability, and strengthening of processes led by digitalization initiatives. The strong balance sheet position allow us to continue to invest in the right set of opportunities for future growth.
Now, let me take you through the key business highlights for each one of our businesses. Please note that all references to the numbers in this section are in respective local currencies. Our North America generic business recorded sales of $235 million for the quarter, with a growth of 40% year-over-year and a decline of 5% on a sequential quarterly basis.
While the new product launches momentum continued through the quarter, we faced incremental competition, led pricing erosion in certain base portfolio products. Toward the end of the quarter, we also witnessed signs of COVID-driven slowdown in demand levels, especially at the retail and hospital level, impacting resourcing. We launched five new products during the quarter, sapropterin tablets, cinacalcet, succinylcholine injection, and relaunched OTC Motrin tablets in the U.S. and daptomycin injection in Canada market.
Overall, during the nine months in current fiscal, we have already launched 22 products, including one relaunch. As we continue to maintain the launch momentum for the rest of the year, resulting in around 30 launches for the fiscal, we remain focused on ramping up of the market share across key recent launches. Our Europe business recorded sales of EUR 47 million, with strong year-over-year growth of 20% and sequential quarter growth of 9%.
The growth was driven by new product launches seen across the markets. During the quarter, we launched three new products in Germany and one product each in U.K., Italy, France, and Spain. Our emerging markets business recorded sales of INR 962 crores with a year-over-year growth of 5% and sequential quarter growth of 11%. The year-over-year growth, adjusted for the Forex rate impact, has been also in double digits.
Within the emerging market segment, the Russia business grew by 4% year-over-year and 17% quarter-over-quarter in constant currency. The market demand has been gradually recovering after COVID-19-related decline. We also saw similar improvement trends in our CIS market. Our business in China also continued to perform well in the quarter. During the quarter, we launched 27 new products across emerging markets.
We also completed acquisition of select anti-allergy brands from Glenmark for Russia and CIS markets. Our India business recorded a sale of INR 959 crores with a year-over-year growth of 26% and a growth of 5%. The strong growth in the quarter was supported by gradual improvement seen in the market demands. The brand acquired from Wockhardt have also performed well.
We are progressively adapting digital platforms to improve connect with the various stakeholders, physician community, patient, and channel partners to expand access and leverage demand platforms. During the quarter, we launched seven new products in the India market. As per the AIOCD AWACS report of December 2020, we have been ranked number 9 for the month of December and 11 on a MQT and MAT basis.
Our PSAI business recorded sales of INR 95 million with a year-over-year decline of 2% and sequential quarter decline of 17%. As I alluded to you in the last quarter, part of the high growth in the first half of the financial year was driven by higher API procurement inventory level carried by our customers in response to the COVID-19-related disruptions. This part of demand has largely been normalized.
At strategic level, we continue to believe that our PSAI business is well-positioned to benefit from evolving structural shifts in the industry as we continue to invest into new product development and cost reduction initiatives. On the R&D front, we continue strengthening our pipeline of products across the markets with focused R&D investments to our value accretive assets.
During this quarter, we filed 57 formulation products across global markets, including two NDAs in the U.S. As of December 31st, 2020, we have 89 cumulative filings pending for approval in the U.S. FDA, which include 87 ANDAs and two 505(b)(2) NDAs. We also filed 45 drug master files globally, including five filings made in the U.S. We are also progressing with phase III trials for infliximab and working on the next wave of biosimilar products, which are at different stage of development.
We remain committed to strengthen our product pipeline across markets as one of the key levers for driving our future growth. As the uncertainty surrounding COVID-19 progressively recedes, we remain focused on our key strategic priorities of building sustainable growth stories across various businesses, including inorganic move and strengthening the pipeline to enable long-term goals. With this, I would like to open the floor for questions and answers. Thank you.
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 yourself 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. The first question is from the line of Shanti Patel from Shanti Patel Investment Advisors. Please go ahead.
Could you light on capacity utilization in respect of various verticals? Question number two, this impairment loss, how it is determined, and will it be reversed in future if situation changes? Please throw some light on that.
Yes. We had a triggering event of the launch of Novelan by Teva, and we are working according to the good accounting practices, as this is a triggering index event for that. We are still planning to launch these products. There is no plans to reverse. I hope and believe that we will launch these products and make money from them.
Mr. Patel, does that answer your question?
Capacity utilization. What is the capacity utilization in respect of the various verticals?
The capacity realization?
Yeah, that is correct.
We have enough capacity for those verticals. I'm not sure I understand the question.
No. Capacity utilization means suppose we can produce 1,000 units. Okay, we are producing only 900, so 90%. That way, what is the installed capacity and how much we are producing, the ratio.
I got you. I'm saying again, we have enough capacity for all the verticals. The only places in which we need additional capacity is in the injectable arena and primarily for the years of 2022, FY 2023 and FY 2024, as well as the biologics. We have enough, so the growth will be also.
Okay, thank you. Thank you.
Thank you. The next question is from the line of Rashmi Sancheti from Incred Research. Please go ahead.
Yeah, thanks for the opportunity. If you can highlight what kind of growth we are seeing in India business ex-Wockhardt integration.
We are now splitting the growth. Amit, you want to answer it, Amit?
Yes, Rashmi, thanks for the question. Excluding Wockhardt portfolio, our base business grew at about 8% during the quarter.
Thank you. Sir, for the nine months?
For the nine months, also the business grew in single digits.
Single digits. Okay, sir.
Yeah.
Sir, related to the Wockhardt integration expenses in this quarter, is it going to continue in the subsequent quarter or, this is one-off and this will be only in this quarter? Whether, if you can quantify, how much that additional cost has come?
Yes. We have now successfully integrated the Wockhardt portfolio into our business, and what our P&L reflects are the normal ongoing expenses. There are no one-off expenses pertaining to the Wockhardt business in our P&L this quarter.
Okay. That integration expenses will it continue in the subsequent quarter or it is already over by third quarter?
Rashmi, this integration expenses, there is nothing integration expenses. It is the same cost like we have got from this business. That is now part and parcel of our business. That will continue. It is on account of incremental manpower cost, S&M cost, the plant which came from Wockhardt. Those expenses on a year-on-year basis, that's the reason we have mentioned. On a sequential quarter basis, that is not the reason. It was there in Q2 also. It is there in Q3 also.
Okay, sir. Got it. Sir, finally, on the U.S. business, are we going to maintain our 30 product launches guidance in U.S. for this entire year? We have already launched around 22 products.
Yes, we are planning to do this in this calendar year.
Okay. Finally, last on the pricing on the base portfolio, are we seeing a huge price erosion in double digits sort of, or it is a mid-single-digit price erosion? With the traction in launches, will it go down or it could remain at the same level?
It's not huge. Of course, it differs from product to product, but it's more than it used to be in the other quarters for us. I believe that the business will continue to do well also in the future.
Okay, sir. Thank you and all the best.
Thank you. The next question is from the line of Damayanti Kerai from HSBC Securities and Capital Markets. Please go ahead.
Hi. Thank you for the opportunity. Continuing on the U.S. business, while we are seeing a healthy number of launches, but on the filing side, I believe it's been a bit muted for last few quarters, and we are also having around 87 pending ANDAs. In the past you earlier expressed your goal about increasing your U.S. sales by 50% in next three years. How do you see a pickup happening on the ANDA filings front? Second question on the U.S. business is, any update on Vascepa and Revlimid generic launches?
On the filing, I think we are going to see much more filings in this quarter. It's in line of what we discussed in previous meetings, so we are in the same place. Just in terms of distribution between the quarters, more will happen in Q4. As for Vascepa, we are preparing for the launch of the product. Sorry, there was another one?
Revlimid.
Revlimid will be some time away, Damayanti. It will take some time for us.
Okay. My second question is on the impairment part. For acquiring eight ANDAs from Teva, we paid around $350 million, and if I'm correct, we have already taken impairment of around $250- $260 million due to change in market conditions. Do you feel like the remaining asset value can also be impaired if we see further deterioration in the market conditions?
We are not expecting any additional impairments.
Sorry, I didn't get that.
We are not expecting additional impairments.
Okay. My final question, how should we look at API business growth picking up from here? Obviously, 1H was very strong, as you said, it's normalized now, how should we look at that part of business?
We are going to grow this business on both the external sales as well as much more important for us is the back integration. We are working on both. We are going to see growth in the API in the future.
Okay, sure. Thank you.
Thank you. The next question is from the line of Kunal Dhamesha from Emkay Global. Please go ahead.
Hi. Thanks for taking my question. The first question is on the other expenses. I think in the opening remarks, our CFO said that there was some one-time expense that was included. Can you throw some light on what was the nature of the expense, and can you quantify it?
Thank you for the question, Kunal. One-off expenses that I referred to are primarily two. One is COVID-19 related freight expenses have been at the higher end, as you know, for the last few quarters since COVID-19 started. We are not seeing any moderation in the rates yet. It's a very marginal reduction. We do think as situation normalizes and COVID-19 comes under control over the next few quarters, this is going to reverse. That's one reason I mentioned as one-off. Secondly, we also have some one-off litigation expenses that we have recognized during the quarter, which are non-recurring in nature.
Okay. If I see the quarter-on-quarter, last quarter, our SG&A expense excluding D&A was around INR 983 crores, and this quarter it is somewhere around INR 1,120 crores. Can we attribute the entire increase to that? We have said that Wockhardt integration costs were already there in quarter two, so the entire thing is related to. The freight cost would also be there in quarter two, right? The entire difference is coming from the one-time litigation cost?
No, that's not right, Kunal. Let me give you the shape of the increase. As I said in my remarks earlier, the largest increase is driven by investment behind sales and marketing in the branded markets. In markets like India and Russia, we are seeing the market growth is showing some gradual signs of pickup, and we want to make sure that we invest ahead of the curve.
We have started in a cautious manner, investing behind our brands in these markets. The second thing that we are investing behind is our digital capabilities. We have a very ambitious program in place where we want to digitize our core, our quality systems, our manufacturing plant, the way we manage the entire process of product selection to launch. Also we are digitalizing our front end, the way we go to market, the way we engage with the doctor.
I would say that investments behind brands and capabilities is a large part of this increase. The rest, as I said, is some bit of freight. In this quarter, we have seen higher freight costs compared to the previous one. To some extent it is also because of a higher air to sea shipment, partly COVID related, but also partly the mix between air and sea shipments.
Okay. Do you think that this investment in the brands and sales and marketing will continue for next three, four quarters before it kind of normalize? How should we look at it? Is this the new normal of SG&A, like INR 1,100 crore?
See, as you know, Kunal, we don't give any forward-looking guidance. At the same time, I would like to say that the investment in sales and marketing, we do expect it will continue. I must also point out that we evaluate return on investment on a continuous basis. If we are finding sales growth is being driven by the investments, then we continue. Otherwise, we also try to pare it down. That's one point I would make. Obviously, the COVID-related expenses will gradually normalize.
Okay. Thank you for that. The second question is more of a housekeeping question. I think we took $156.5 million of impairment charge for NuvaRing in Q3 FY 2020, and we took another $40 million-$45 million this quarter. That adds to around $200 million. The purchase price allocation that we did for this product was around $185 million. I'm not able to. What am I missing here? Did we capitalize some of the R&D expense that we did on the product?
Yeah, that's a good question, Kunal. The difference is because of the interest that has been capitalized in line with the accounting standards.
Okay. Yeah. Thank you. Thank you for taking the question.
Thank you. The next question is from the line of Nithya Balasubramanian from Bernstein. Please go ahead.
Thank you. My question is a follow-up on the SG&A expenses. In the last quarter, at least in branded markets like India, China, Russia, I'm assuming that all the clinics are open, the reps are back on the ground. The kind of savings you probably realized in Q1 and Q2, most of the costs are likely to have come back. Is that also partially the reason why it's gone up? Should we now assume that there are no longer any lockdown related savings in the base anymore?
I think to a large extent, I would say it is getting normalized. That's true, Nithya. I would not say we are back to pre-COVID levels. Yes, it is getting normalized. That's a fair statement.
Can I take that to mean it's likely to inch a little higher because it's not fully back?
Yes, it will gradually pick up, but as I said earlier, we maintain a very tight control on our investments, and we link it to sales growth. Ultimately, these investments are linked to the growth that we can deliver. Yes, you can expect that gradually we will go back to pre-COVID levels.
Okay, understood. Thank you. The second question was on some of the material products that you have filed in the U.S. or are likely to file. If you can give us an update on where you are on NuvaRing, COPAXONE, I think you mentioned you refiled. Do you have a CAD date? If you can update us on those two products.
Yes, I'll do that. On NuvaRing, we submitted the response to the CRL in December, and now the ball is back into the court of the U.S. FDA. We will wait for the response from the FDA and accordingly prepare for a launch. As for COPAXONE, we received the CRL and we are now addressing it. This is the status of these two assets.
Sorry, Erez. I hope I got that right. You've received another CRL on COPAXONE , and you are preparing a response. Did I hear that right?
Yes. Correct.
Any timeline on when you're likely to resubmit?
We are still testing, but I believe it will be within the next few months.
Thank you.
Thank you. The next question is from the line of Vishal Manchanda from Nirmal Bang Institutional Equities. Please go ahead.
Thanks for the opportunity. On the domestic side, is there a seasonal element to the Wockhardt portfolio, kind of? Is Q3 a large quarter for the Wockhardt portfolio, or is it normal across all quarters?
There is no significant seasonal element, I would say. As I said earlier, Wockhardt portfolio is performing well. It is exceeding internal expectations, and we believe that we'll maintain growth at similar levels for this portfolio.
Okay. Second one on the Sputnik vaccine. Just wanted to understand whether this could involve marketing and you would need to distribute it in the private market, or would this be a sale to the government? Whether you would also be allowed to sell in markets outside India?
We are planning to go to both the government as well as the private market. Of course, in accordance to the guidance that will come from the Indian government about priorities and how do they see that. This is still in discussion or will be in discussion also in the future. What was the second part of the question, sorry?
Would you also be allowed to sell it outside India, in emerging markets?
Yes. We are discussing with RDIF options to increase the collaboration also to other markets.
Okay. Thank you. That's all from me, sir.
Thank you. The next question is from the line of Neha Manpuria from JP Morgan. Please go ahead.
Thank you for taking my question. If I heard the number correctly, you said that excluding Wockhardt, our India business is growing about 8% in the quarter. Which would imply that Wockhardt revenues are pretty much back to their peak sales level. Is that correct? If that is the case, how should we look at momentum for Wockhardt from here? What will drive incremental growth or what you're indicating inline growth for Wockhardt from here?
I believe that the Wockhardt products will continue to grow from here as well, yeah.
What would drive that growth, Erez, since most of the low-hanging fruit is already there in the numbers?
I think that it was primarily our ability to invest behind these products and to full-staff the activities that these products demanded. I think this is both the sales synergies as well as the cost synergies that we anticipated it to have, and it is working well so far.
Okay, understood. Okay, I'm not sure if I caught this in your opening remarks. Our working capital seemed to have increased in this quarter, both receivables and inventory. Could you indicate if there was anything specific here that you'd like to point out?
Yes, Neha. On receivables, approximately the increase is INR 300 crores. I would say roughly around one third or slightly higher than that is because of lower discounting of receivables in the U.S. That's because we are no longer finding it economical because of the drop in interest rates in India. That's the fundamental reason. The second reason is an increase because of normal sales growth that we see.
Finally, the milestone payment that we had received from Aurigene is another driver. Overall, I would say the receivables increase is due to the underlying business drivers. On inventory, again, part of it is because of sales growth, and the rest of it is a planned increase. We want to make sure that our safety stock levels are adequate and there is absolutely no disruption as we enter Q4. These are the reasons for the increase in working capital. I hope I've answered the question.
Understood. Okay, fair enough. One other clarification on the U.S. business. The price erosion that we saw quarter-on-quarter, was that related to any specific product, or was it across assets and across the portfolio that could probably continue?
It touched more than one product. It's not specific. It's like the normal course of business, but it's not the entire portfolio. Like always, in United States, when competition is coming, we need to react to it if we want to defend the share. This is what happened in this case as well.
Understood. Thank you.
Thank you. The next question is from the line of Kunal Mehta from Vallum Capital. Please go ahead.
Sir, thank you very much for the opportunity. Sir, my first question was on NuvaRing. Just wanted to understand the rationale behind the write-down of the entire product, because I think it's still a viable product, and of course, from an IFRS perspective, when you consider the five-year period, it's practically neutral because it just accelerates the amortization. Wanted to understand the rationale behind writing down this whole product.
No, the rationale is, we have a triggering event with the launch of Teva, so change, of course, the model around this product. As we address the CRL only now, and it depends, of course, on the time that we will obtain approval, in accordance with good accounting standards, we had to depreciate this asset. Yes, you are right, we are still committed to this product. Hopefully, the FDA will approve the product and then we can launch it and make money out of it.
Understood, sir. Sir, the second question I had, I wanted to understand regarding the emerging markets. I'm sure in the opening remarks, you mentioned that a lot of the filings which you have done this year, especially in this quarter also, most of these are dedicated to emerging markets, ex-U.S., I would say, ex-U.S. markets, including Europe and Russia, CIS, and the other emerging markets, all the smaller ones.
Just wanted to understand, of course, there is a lot of understanding available to understand the U.S. portfolio, but on the emerging market side, could you please give us understanding of the new product launches which we have targeted over the next two, three years? Any sense could you give us on, let's say, if we are targeting these markets to grow by, let's say, maybe 15% over the longer two, three years perspective, then any target whereby what would be the contribution of the new product launches for these markets?
You know we are not giving targets, but I'm expecting, especially on the institutional and hospital, that this product will significantly contribute to the growth in this area. As you recall, when we discussed our strategy, we are taking our global products portfolio and try to find as many markets as possible in order to get much more dollar sales for investment in R&D, and that's what we are doing.
You are going to see more and more filings in the rest of the markets. Most of the development that we are doing now, we are doing globally, and not necessarily for a specific market. It's in line with the strategy that we have discussed, and what you see is the fruit or the starting of the fruit of this execution. We are going to file more and more.
Understood. Just the last final question from my end, sir. I just wanted to understand the strategy which we have on the injectable side. Firstly, could you please give us a number from the outstanding portfolio of outstanding filings in the U.S. ANDAs, how many are on the injectables? If you could break it down between complex and, I would say rather, simple ones on the injectable side.
Of course, you've mentioned in your 20-F that from the U.S. business, roughly one-fourth comes from the injectable portfolio. Maybe I'm talking about FY financial 2020. I would say, any perspective on how we want to take this business ahead, because I think considering the fact that a good portion of the off-patent products are now in this portion of the market for the next five years. Any perspective on how we want to take this business ahead in the U.S.?
Yes, of course. Our injectables are global products, and we want to develop, and most of our investment in that area is for global products, including the U.S. The impact on the U.S. is that more and more injectable products will be filed in the U.S. Proportionally, the injectables will be higher than they used to be in the past. If you wish, in the U.S., complex and injectables will grow, and the simple in the U.S .
Okay. If I please have to at least say that from the 25% current contribution, over the next three, four years, this contribution will only move upwards in terms of the overall portfolio.
Yeah. The weight of the injectables will be bigger in the future.
Got it, sir. Thank you. Thank you very much. All the best for the future.
Thank you. The next question is from the line of G. Vivek from GS Investment. Please go ahead.
Yeah. Is my understanding correct that the tailwind our pharma sector was having due to COVID is now weakening, and are we back to the time of price erosion getting on very severely instead of the single-digit price erosion due to consolidation we faced?
You are talking about the United States?
Yes, U.S. and rest of the entire world market. Basically, the tailwind due to COVID-19 for pharma sector in India was responsible for very good performance in Q1, Q2. That is now weakening.
We are in the 10th across from the market, but we are not yet in the pre-COVID level or the pre-COVID behavior. There are still impacts of COVID in certain areas. For example, in the U.S., we do see still that certain products are affected by the ability of people to meet physicians and stuff like that. We do see that these products are softer than they used to be.
In terms of price erosion in the U.S., it's primarily related to competition. When competition is coming, this is what is causing the price erosion. It's not so much a COVID impact. In the case of India, we absolutely see a pickup as the Q3 was a quarter in which by and large the activities of India came back almost to a normality. We are not there yet, but we are almost there.
Is the similar situation prevailing for injectables also, or is it mostly for oral solids? Injectable also, the price erosion is severe?
No, the price erosion is affected by both injectable and oral solids. It's not related to COVID. It's related to competition that is coming. It's in both segments in the case of the United States.
The good part for our company was all our five plants were FDA approved, and maybe after some gap also. Now FDA inspection have again begun in India and any FDA inspection due for any of our plants in India?
We did not get any requirements from the U.S. FDA yet. In general, it's a good news that the U.S. FDA is starting inspections. It's a great news, actually.
Okay. Thank you.
Thank you. The next question is from the line of Nitin Agarwal from DAM Capital. Please go ahead.
Hi. Thanks for taking my question. It is on the U.S. business. During the year, we've launched, as you mentioned, 24 products so far, but there's not been much pickup in our Apotex sales run rate number. What do you hear assessment it really take to meaningfully move this number from the $240-$245 that's being sort of stuck around for last couple of quarters?
Sorry, I could not hear well the question. Can you repeat it, please? Sorry.
Sir, my question was, we've had 24 new launches during the year in the U.S., our run rate still continues to be below around $240 million per quarter run rate. In your assessment, what will it take for us to really break through, to meaningfully scale up from these levels? Given the fact that number of launches clearly it's not been a hindrance so far. We've done a fairly large number of launches even this year.
You know it's the number of the launch and also the type of products that we are launching. It's a combination of, first of all, I believe that the portfolio moving forward is attractive, and it should create a growth as the products that hopefully we are launching should give us the growth we are looking for. It's not just the quantity, but it's also what you call the quality, the size of the product that's going to be launched. Some of the products coming up are interesting.
Okay. Secondly, on the gross margin, we've had a fairly sharp drop in the gross margin, the generic business this quarter, if you adjust for the licensing income. How should we read this? Is this the new normal to go with given the fact that the export incentives are no longer there? How should we sort of model in the generic gross margins now going forward, the generic business gross margins?
Yeah. Like we said in the past, we are not managing the gross margin per se. We are actually managing the EBITDA. We are maintaining that we are staying and sticking to the 25.5 that we showed in the past. We are already in this neighborhood and planning to stay in this neighborhood, and maybe even more for a while. A gross margin is a matter of mix of activities.
For example, if we have a great product that will give us 50% gross margin, then it will be profitable with the right EBITDA, we will take it. We are not managing the percentage, we are managing the nominal gross margins. In general, what we said, and we are still there, that we will stay around the neighborhood of the gross margin that we were in the past. We are not managing it per se. We will continue to take businesses, if they are profitable, even if they will be below this number that we have now.
Okay. Thank you very much. Best luck.
Thank you. The next question is from the line of Sameer Baisiwala from Morgan Stanley. Please go ahead.
Thank you, good evening, everyone. This is an important launch, which is Vascepa, let me ask a question on this. I'm not sure how much you can talk. Would it be like your regular high-value launch or would it be volume-constrained like the first entrant with the lower margins, it would improve as you go along? Any thoughts would be very helpful.
Yeah, Sameer, you know I cannot tell you that. It's absolutely going to be an important launch for us. Okay, that's what I can say, but I'm not going to discuss quantities or anything like this for obvious reasons.
Okay. Sir, can you confirm that this would be a regular high-value launch for you?
This should be a high-value launch for us, yes.
Okay, great. Thank you. Sir, second question on Sputnik V. Just if you can tell us what's your sourcing plan for the vaccine? Second is there any change to your earlier launch timelines and 100 million volume target? That'd be great.
The 100 is now 125. This is one update. We are discussing more countries. We are now rolling up, actually, we initiated already phase III, the 1,600. By March, we hope we can submit it to DCGI, the Emergency Use Authorization application. If we will get it, we can launch in March.
Okay, what about the sourcing plan? Would you be taking it from your partner, RDIF, or would you also be doing some manufacturing?
A little bit from Russia and most of it from India with two partners.
Okay. Got it. Very helpful. Sir, the other question is on the Aurigene outsourcing of AUR-102. This is pre-phase I sort of outlicensing to Exelixis. It's a very early-stage outlicensing thing. What's the thought process behind this? You would have taken it to phase II or even early phase III and then put it out-license.
Yes. We and Aurigene developed over the years very interesting pipelines. Some of them we are planning to continue to develop to a later stage. Some of them we are planning to monetize in early stage in order to allow Aurigene to be self-sustained in terms of risk/reward management. I think that Aurigene has a very interesting pipeline going forward. Those that we want to keep and continue to invest beyond that, we will not monetize at an early stage. We'll do it later.
Okay. One final one, if I can. Parag, if I'm not wrong, you mentioned that the EBITDA margin internal aspiration is 25%. If so, if you could say that, and you are very close to that already. What's the outlook for margins and what are the levers for that? Thank you.
Yes. As I said, our aspiration and need is to deliver 25% EBITDA on a sustainable basis. While we are in the neighborhood of 25%, we are not yet able to consistently deliver 25%, and we have a number of levers to get there. I think the biggest lever obviously is top-line growth, and second is productivity that we are driving very hard across the value chain. I can talk about it in detail. We drive productivity formulation, the chemistry, how we can run our machines more efficiently, how to improve the yield, finding alternate vendors for our materials, and so on. Also in S&M, and so on. Productivity is a big driver, and we want to make it a habit.
I must point out that as we drive productivity, we also need to invest some of it back into the business behind our brands and behind capabilities, digital capabilities I spoke earlier. It's very important that we drive the levers that can potentially improve the margin, but we also invest behind the business so that we can deliver sustainable growth in the future. I would say that we are in the neighborhood of 25% EBITDA aspiration. I think you can expect that in the next few quarters. We should be in that range.
Okay, great. Thank you very much. Very helpful.
Thank you. The next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.
Yeah, thanks for the opportunity. Just to follow up on this, you clearly mentioned 25% over a few quarters on a sustainable basis. If I get my math right, particularly this quarter, if you strip the licensing income, then you are around 21%. You mentioned that there are some structural cost up-gradation which would happen or will continue over a few quarters. I'm just trying to get these two together. Currently, we are at 21%. Last two quarters were 25%. There's a 400 basis gap here. Actually, we are not near 25. If you could explain that. Do you want to say that the cost is truly one-off here? That would be helpful. Thank you.
No, that's not right, that the cost is entirely one-off. Let me clarify that first of all, the impact of the Aurigene milestone payment is around 1%. We have delivered EBITDA margin of 24% during the quarter, and even if our EBITDA margin is around 23%, excluding the milestone payment, it is within normal range.
I must also say that we do drive out licensing in a number of our businesses, like proprietary products and Aurigene, and biologics business fairly regularly. I'm not sure it is fair to exclude or include a milestone payment. As I said earlier, we are driving productivity, and we are also investing behind the business. We are right now in the neighborhood of 25% margin, and we will continue to drive that as our long-term aspiration.
Okay. Can you confirm the increase in expenses are recurring apart from the small one-off you mentioned, and you can quantify that one-off, please?
I don't think I can quantify the one-offs. In terms of the increase in cost, as I said, it is an investment behind our brands. We do expect it to continue, but it is also linked to growth. We have a process to manage return on investment, and therefore, it is linked to growth. In summary, I think this level of investment, we expect to continue, but it is directly linked to the sales growth that we can deliver.
Perfect. That helps. Very helpful. Sir, on China. I think with COVID, everything is muted, but what is the ground-level action in terms of the filing momentum, how it has been in the last nine months, and has it started to pick up, and when do we see the next round of approvals for us?
China is doing very well for us. We are also growing in China despite COVID, and we already filed 15 products and out of a list of about 100 products in the pipeline that I shared with you. We are very much on track with these offerings for China.
Sir, you mentioned 16 products filed and growing double-digit. Did I hear that right, sir?
What I said is 15, and I did not say anything about the digits.
Okay. We are growing in China despite COVID.
We are growing in China despite COVID, even nicely. We already submitted 16 products on top of the products that we already have in the market.
Perfect. That is very helpful. Thank you. Sir, on the API PSAI business that we have, clearly, the first two quarters, very heavy. You mentioned stocking, supply disruption. How do we see the outlook going forward, given that in the last call we mentioned that it's strategically important to us and we want to invest in this business?
We will grow our API business. It will grow. Maybe not quarter- on- quarter, but it will grow. It will grow, and it's very important for us, and we are going to increase also the level of integration over time.
It has two parts, if I'm not wrong, the API and the pharma services. You carved out Aurigene out of it. I just wanted to understand the growth trajectory for each of the business.
Both will grow. We are not giving guidance, both will grow.
Okay, understood. Lastly, sir, on pegfilgrastim, is there any update in terms of where we are in the overall approval scheme?
Which one, sorry?
Pegfilgrastim.
Yes.
Yes.
The pegfilgrastim. Go ahead.
Yeah. That program is run by Fresenius. They filed the product. We haven't heard anything about approval, but we expect in FY 2022, but we do not have any confirmed date.
Okay. Thank you and all the best.
Thank you. Ladies and gentlemen, due to time constraint, we will take that as the last question. I now hand the conference over to Mr. Amit Agarwal for closing comments.
Thanks everyone for joining us today for the earnings call. In case of any further queries, please reach out to the Investor Relations team. Thank you.