Strides Pharma Science Limited (NSE:STAR)
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Sep 11, 2026, 3:29 PM IST
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Q1 21/22

Aug 6, 2021

Operator

Ladies and gentlemen, good day and welcome to the Strides Pharma Science Limited Q1 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, please signal an operator by pressing star then zero on your touchtone telephone. Please note that this conference is being recorded. I now hand the conference over to Mr. Abhishek Singhal. Thank you, and over to you, sir.

Abhishek Singhal
Investor Relations Representative, Strides Pharma Science

Thanks, Manisha. A very good afternoon, and thank you for joining us today for Strides earnings call for the first quarter ended financial year 2022. Today we have with us Arun, Founder and Non-Executive Chairman, Dr. Ananth, Managing Director and CEO, and Badree, Executive Director in Finance and Group CFO to share the highlights of the business and financials for the quarter. I hope you've gone through our results release and the quarterly investor presentation, which have been uploaded on our website as well as the stock exchange website. The transcript for this call will be available in a week's time on the company's website. Please note that today's discussion may be forward-looking in nature and must be viewed in relation to the risks pertaining to our business.

After the end of this call, in case you have any further questions, please feel free to reach out to investor relations team. I now hand over the call to Arun to make the opening comments.

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Thanks, Abhishek. Good afternoon. Good evening. Thank you for joining today. It has been a difficult quarter for Strides and, incidentally, it is the first quarter in its history that we have an operating loss. That makes it even more harder. Having said that, we are in the midst of a situation that is not exclusive to Strides. Based in Bengaluru, we have had a very difficult quarter operating our manufacturing facilities, leading to significant supply chain disruptions in our contractual obligations to customers worldwide.

This has resulted in a significant amount of failures to supply, which we have never incurred as a company. Typically, Strides pre-COVID had a failure to supply ratio of less than 0.5% of its revenues. That has gone up quite significantly in the last two, three quarters, and it magnified in the last quarter, especially because of the shutdowns that we had in our plants in Bengaluru.

More importantly, it also impacted our contracts, which led to air freighting significant amounts of products that we would normally ship only by sea, resulting in an incremental cost of almost $6 million only in our U.S. operations. More importantly, as is now visible to most of you, we are seeing significant competitive landscape on acute therapies and Strides being predominantly an oral dosage company and focused on acute therapies predominantly has been hit quite severely. We chose strategically, given that we have a principled approach to pricing, to let go our businesses, considering that, as most of you know, that if we accept to lower our pricing and stick to contracts, we sign up with most favored conditions with the other buyers, which will result in significant price drops.

Consequently, we let go of several businesses, as competition in the absence of product approvals was fighting for larger share of the wallet. Obviously, we had sight of the Endo transaction in terms of the very significant pipeline that we were acquiring, and that gave us more confidence in taking these kind of bold decisions, which we think are very temporary in nature. If you look at our guidance, what the Endo transaction has done for us is not only doubling our approved ANDAs, but most importantly, adding a very significant amount of portfolio products that is magnified by the fact of lack of Indian competition, which requires dedicated manufacturing capabilities, which facility brings to the group, including products like hormonal gels, nasal sprays, and significantly increasing our extended release programs.

Most importantly, we have a DEA license to manufacture. This portfolio includes several specific products in the category two controlled substance product range, which will significantly add to our business. As Endo is re-strategizing its focus to become more a branded company, we had the ability to have structured this deal, which we think is significantly accretive to Strides, which will include the transfer of 20 commercial products on closure. You will notice that we have been a little sketchy in terms of exact details of sales, number of ANDAs, programs, specific products. This is because we are still in agreement with Endo to conclude the contract in the next 60 odd days from a signing to closing, and we will be more than delighted to give you more color around the specifics of the products.

Having said this, we are now in a very strong position to confirm that we have achieved two significant goals. We have had a dry run with our product portfolios in the last two years, considering that COVID-related travel restrictions meant that the inspectors were not inspecting facilities or even the BE centers, although this has now commenced in the last few days. This has led to significant drop in product approvals not only for us, but for everybody. From an average of 15-20 launches per year three years ago, we are now down to four to five relevant launches. This is not material, especially when we have an onslaught of price-intense pressure on our portfolio.

The transaction that we announced today not only adds a very significant number of products, but they are unique products, which we are now very confident to guide and confirm that our phase I strategy of achieving $400 million of revenues on small niche and difficult to manufacture programs is now fully secure. We are now not dependent on any incremental R&Ds or product approvals to get there. Consequently, on closure, we are confident that in spite of a very weak Q1 in the U.S. and what we think will be a subdued Q2, we will rebound in H2 as a very significant player to confidently guide that we will grow our business at least by 10%-15% over the last year.

You will also appreciate that Strides' guidances of the U.S. sales have been achieved in every year that we have provided. We do not see any reason why we will not achieve that this year. I will let Ananth speak on specific accretion and transaction details. Today, while we are not happy with our performance, which is some in our hand, many not in our hand, we think that we are now well-poised from a strategic play to deliver on what we think will be a very compelling story in the near term. With this, of course, I will also take one minute to just quickly give an update on Stelis. First of all, I am delighted to welcome Mark as our new CEO.

As many of you have seen in the releases, Mark comes with stellar experience and success in the business, having run AGC Biologics, which is one of the largest CDMOs in the world. Mark is relocating to India. He's on his way to India and will stay invested here in Bengaluru, which is great given the need of a leader of his type to be operating from Bengaluru. We are also delighted that we have strengthened our board by inducting Dr. Vineeta Rai onto our board, also for Aditya Puri to have kindly agreed to be the chairperson of Stelis as we build Stelis into a very exciting journey. As regards Sputnik, as guided in the previous earnings call, we have successfully now completed our scale-ups for both the rAd5 and the rAd26.

Like most partners of the RDIF, we continue to have challenges on the yields for the rAd5. We believe that this is something that will be fixed. There's no change to our guidance to start large-scale commercial production in October. In spite of COVID and a 40-day delay in our manufacturing projects, we have now received all our equipment at site or at ports. We are now confident to get started for commercial production in large scale soon. With that, I'm going to let Ananth speak about the business he runs. Today, more as representing the board, I thought it necessary for me to give a little more color than I would normally do in an opening statement. Thank you for your patience. Be rest assured that we are in a strong wicket to rebound very strongly.

With this, I pass it on to Ananth and then Ananth later to Badree, who will give you an update on the finances. We are obviously open for questions. We also understand that today is a crowded day for calls, so we will try and make this meeting short. As always, we will be available to take your calls and answer any questions you may have, anytime next week or whenever you want us to get onto a call. Thank you.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Thank you, Arun. Good afternoon to all of you, and hope all of you and your loved ones continue to remain safe and healthy. As Arun mentioned, Q1 has certainly been a disappointing quarter for Strides amidst multiple headwinds with the recent wave of COVID. The sector has certainly seen significant headwinds on multiple counts. Just to give some flavors, we've seen drop in prescription rates below historical levels in the U.S., significant drop in prescription rates in the U.K. with lockdown throughout the entire quarter, and there has been continuous drop in product approvals for the industry. All of this has resulted in a heightened competitive intensity, of course, to capture a higher wallet share, which has resulted in significant price erosions this quarter.

Also, with the rise in the COVID cases in this quarter leading to the lockdowns, there has been a disruption in supply chain that necessitated increasing cost of operations, particularly logistics. We have seen the significant impact of these dynamics on Strides. Our U.S. portfolio has seen a double-digit price erosion and higher competitive intensity, resulting in significant drop in revenues. We also had an impact where some of our new product launches from the last quarter have not played out as anticipated due to the steep erosion in those products. While there has been a gain in Q4, it has resulted in a steep drop in Q1. We also saw for our products in the pipeline delays in product approvals. Of course, our manufacturing sites in India were impacted with a number of our employees getting affected by COVID, and that led to operational and supply-related impacts.

With all of these elements, it was at an opportune time that we do have the transaction, which is the acquisition of a basket of ANDAs from Endo and the manufacturing site at Chestnut Ridge, New York. This certainly comes to us in a way to be able to enable us to mitigate these headwinds. What does this transaction mean for Strides? I'd like to give some color to this. Firstly, adjusting for overlapping products, our product portfolio of about 100 approved ANDAs will more than double after this transaction. We do get access immediately to 20 commercial products that get added to the portfolio upon closing. Since these ANDAs are approved, it mitigates any delays in approvals that is normally needed for launch of new products.

Hence, we are going to be pretty busy after the closing to ensure that our velocity of launching about five to six products from the acquired portfolio every quarter is set up in motion. This acquisition adds additional dosage forms and capabilities that currently do not exist in our portfolio. Some of these are hormonal products, controlled substances, particularly the Schedule CII category, gels, nasal sprays, and also significant enhanced presence in modified release and liquids, apart from solid orals. The portfolio also enhances significantly our middle of the pyramid basket, which is the area where we have limited competition products with superior margins, and that basket will now increase almost by 2x to over 100+ products. This facility being in the U.S., we now have 100+ TAA-compliant products to enable U.S. government supplies.

We also get access to IP through the acquisition of this basket that can be leveraged to expand product offering for global markets through our portfolio maximization approach. The scale of this combined portfolio now will help us to refocus our R&D, and therefore spends in the R&D will be now more towards complex and specialty programs since building the portfolio of ANDA for launches in the U.S. gets covered through this acquisition. Given the scale and capabilities at this site, we have decided to exit our West Palm Beach site in Florida and consolidate the soft gel capability at Chestnut Ridge, which will give us manufacturing cost synergies. Also, being in the U.S., this site will help us mitigate supply chain and logistics disruptions by in U.S. for the U.S. capabilities.

Clearly now we have sufficient approved products, as Arun said, that will enable us to achieve our stated target of $400 million revenue for the U.S. as our phase I approach over the next 24 months. Despite the impact in Q1 and a likely softer Q2, we remain confident of achieving the growth in FY 2022 over the $215 million that we reported in 2021. Coming to the other Regulated Markets, our other Regulated Markets was certainly impacted by the lockdown in U.K. and over or around 20% lower prescription generations for the prescription and OTC products. We also saw supply disruptions, particularly for our partnered business in the other Regulated Markets. However, we do see an improved order book as well as we're pretty confident of a bounce back starting in quarter two of FY 2022 for the other Regulated Markets.

The business outlook continues to remain robust there and will continue to be on its growth momentum. We will continue to focus on portfolio building and product launches for the other reg market. From an emerging market perspective, the Africa business delivered a steady performance despite lower demand for acute portfolio. Our institutional business did show a sequential decline. One was on account of lower uptake of TLD in this quarter, as well as the sheer lumpy nature of the business. However, we do expect growth for the full year. We've taken several initiatives organization-wide on cost control programs to deliver operating leverage and have also put initiatives in place to bring down logistics costs and FTS during the second half of the year.

In summary, we are confident that with the basket of approved ANDAs and the manufacturing facility in the U.S., we will bounce back in the other Regulated Markets and the U.S., our core business areas, and we will demonstrate recovery in H2 driven by growth across all our businesses. With this, I'd like to hand over to Badree for financial highlights.

Badree Komandur
Executive Director in Finance and Group CFO, Strides Pharma Science

Good evening, ladies and gentlemen. We had a decline across revenue as well as margin metrics. Our price erosion seen in the base portfolio of key products for U.S. and U.K. dragged the gross margins by 10%. We also had a negative operating leverage during the quarter, mainly because of the lower sales as well as the gross margins. Employees over cost moved in a range, and operating costs increased because of logistics as well as some COVID-related expenses, plus the failure to supply. We'll continue to see operating costs at a similar range going forward. We also had an impairment of Palm Beach to the tune of about INR 1.4 billion, INR 1,400 million. Overall, the exceptions were at INR 915 million in the current quarter.

This will help us to save the operating cost, going forward, to the tune of about $6 million-$7 million running the factories as a cost avoidance. Overall, the debt stood at about INR 14.4 billion, and it will be expected to go up slightly with the acquisition of Palm Beach. With the growth returning back in H2, we should be able to come back to the original levels and we'll be able to see a big reduction in the next two quarters, in H2. Overall, if you see from a tax rate perspective, this quarter we had a tax write back of about INR 320 million, mainly because we created a deferred tax on this Palm Beach impairment. ETR is also expected to be in the similar range like in the past. With this, I will forward it to Abhishek and open the floor for questions.

Abhishek Singhal
Investor Relations Representative, Strides Pharma Science

Melissa, can we take the questions, please?

Operator

Thank you, sir. Ladies and gentlemen, we will now begin the question and answer session. Anyone who wishes to ask a question may enter star and one on your touchtone telephone. If your questions have been answered and you wish to withdraw yourself from the queue, you may enter 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. We have the first question from the line of Alankar Garude from Macquarie. Please go ahead.

Alankar Garude
Analyst, Macquarie

Hi, good afternoon, everyone. Sir, while almost all companies have seen an impact in regulated markets in this quarter, the extent of impact on us seems much higher than peers. Among the reasons which you discussed, are there any specific ones where we were impacted much more than the other companies?

Ananth R.
Managing Director and CEO, Strides Pharma Science

The couple of things, as I said. One is, yes, across the sectors we've had, we've seen drop in prescription rates. Two elements that did impact us. One is, as we said, our product portfolio predominantly being in oral solids is in the acute product segment. Number two is the lockdown in U.K. With the lockdown as well as with the vaccination, there's clearly been an impact on the acute portfolio, and that has had a bigger impact to us, number one. Number two is that clearly with number of product approvals coming down, the competitive intensity on existing portfolio has gone up, which has resulted in a steep price erosion, and that's played out to our portfolio.

Alankar Garude
Analyst, Macquarie

A follow-up to that would be, if I look at the U.S. guidance, it suggests a significant ramp-up from the first quarter levels, even as we have indicated a subdued second quarter. What is giving us this confidence for the second half? Broadly, how much would Endo contribute in this?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Alankar, we can't get specifics. Like I said, we can't get into specifics of the Endo transaction till it's closed, right. Clearly, as you would see from the releases, the portfolio of over 100 new ANDAs adjusted for overlapping ANDAs, right. Which means that the portfolio is obviously more than that. Adjusted for overlapping ANDAs, almost every single product fits into our specific criteria of the niche. We have seen price pressure, very intense price pressure on the bottom of the pyramid, where volumes are very high. Either our competitors are sitting on too much inventory and they wanted to sell out. Like I said, we chose not to protect the lower pricing and let go of it, and that is why you'll probably see our drop to be significantly more than the others.

As time goes and when we are in a position to speak more, a lot of the growth is definitely coming from the Endo portfolio.

Ananth R.
Managing Director and CEO, Strides Pharma Science

If I can add to what Arun said. As I said, our H2 is certainly going to be a busy H2, driven with the velocity of product launches that we will have once the acquisition goes through because we will have five to six product launches that we aim every quarter. That's also one that will give a positive uplift.

Alankar Garude
Analyst, Macquarie

Understood, sir. The second question was, generally scaling of manufacturing of the rAd5 dose has been a challenge as far as Sputnik V is concerned for most of the manufacturers. Plus also there's the cross-contamination issue. I think, Arun, in your opening remarks, you also talked about this. Is it possible to share more details on Stelis' relative progress on these two fronts?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Basically, the rAd5 has challenges of cross-contamination at large scale. Typically, to do the volumes that Sputnik is expected to get supply from India, you need to scale this up to the 1,000 L and the 2,000 L for it to be viable. At this stage, people have, with great difficulty, moved from 5 L to 20 L to 50 L and now to 200 L. We are in that evolution phase. What is interesting is that the Russians have worked on the technology, and they've transferred new improvements, which is resulting in better yields. We are seeing that it will be now viable in the near term. Our contract is for their global supplies, and they're also getting Sputnik Light in several markets approved.

We do have a fallback to even at least, if not the Sputnik V, can at least then serve the Sputnik Light.

Alankar Garude
Analyst, Macquarie

Understood. Thanks. I will get back in with you.

Operator

Thank you. We have the next question from the line of Anmol Ganjoo from JM Financial. Please go ahead.

Anmol Ganjoo
Analyst, JM Financial

Yeah. I have two questions. One is to Ananth. Obviously, we knew that last quarter, directionally at least, was supposed to be impacted by COVID. If you look at the trajectory reverting back to normalcy, what has been the experience so far? How have the first few months panned out? I am not looking for numbers, but any directional sense on the route back to normalcy would be helpful.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Anmol, I'll split that response in two or three ways. One, our manufacturing facility has got back on track with a number of our employees being vaccinated as well as recovered. Obviously, the operations have started, which means the supply issue that we had for our partner business is resuming back, and we are getting to fulfill the requirements there, number one. Number two is, we are also continuing to be able to see a good, healthy order book that we need for the other reg markets. Hence, we've indicated that we will see a bounce back for the other reg markets in quarter two. The U.S. will slowly start seeing improvement. Having said that, we will see a softer quarter two or a subdued quarter two, and then come back in H2 stronger. That's what we were indicating in the earlier commentary.

You can't move from one day with a high price erosion and start the next quarter beginning overcoming that. It'll be a softer quarter two and improve as we get into H2.

Anmol Ganjoo
Analyst, JM Financial

Thanks. That's really helpful. My second question is to Arun. Arun, congratulations. Mark Womack looks like a prize catch as far as Stelis is concerned, but just wanted to understand what is the roster of priorities that Mark will be having, and what are some of the milestones we should be watching out for as he tries to replicate his past success with the current asset or the current assignment?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

I think today we don't have a significant CDMO contract with Sputnik, but we have capacities and capabilities outside of other vaccine expression systems. AGC is one of the larger vaccine contract manufacturers. We think Mark will bring his network at play here. That is important. Our mammalian block of 8,000 L is the largest CDMO capacity in the country. That'll go on stream in March as scheduled. As in the mechanical completion will be over by March. This is the right time for somebody like Mark to come into the system and bespoke those capacities for customers who will sign up long-term contracts, because sometimes customers ask for very specialized and dedicated manufacturing facilities. This is the right time from that perspective.

I think his networking around services and other things that AGC does will definitely give us the advantage that we're looking for. More importantly, he was somebody who was more than willing to operate from Bengaluru, which we think was very important as we're building the teams for our scale-up. All of that would be the priorities, building up the team, building new capabilities, creating the organization for a strong BD outcome, and probably announce some big wins in the next six to nine months.

Anmol Ganjoo
Analyst, JM Financial

Thank you. That's it from my side.

Operator

Thank you. We have the next question from the line of Nitin Agarwal from DAM Capital. Please go ahead.

Nitin Agarwal
Analyst, DAM Capital

Yeah. Okay. I was looking on the core business for this quarter. One, big apart from the revenue drop, there has obviously been a sharp drop in the gross margin, about 50% odd versus 60% that we were doing all through the last year. Now, as the business sort of normalizes, is this something which structurally changed in the business in terms of the gross margin of the business, or do we see going back to these sort of levels at some point in time?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Nitin, Arun here. How I see it is that it's a little too early to predict. Will it be in the mid-sixties that we were used to for the last 12 quarters? Looks like it's not. Will it be 50 as is reported? The answer is surely not. I think they give us at least until Q3 for us to confirm that we should be back to a certain level, which is neither the 65 but clearly not the 50.

Nitin Agarwal
Analyst, DAM Capital

Got it. Arun, on that point, is this just our portfolio which has got more impacted, or there has been a broader industry-wide dynamic which happened in the last quarter or so, which has brought this kind of impact?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

I think it's very profound for companies which has a portfolio which is broad-based and not necessarily focused on chronic. Does not have anything which is either in the CGT or exclusivity period or in specialty. Anybody like even Endo yesterday reported 25% drop in sales. Everybody seems to be going through that difficulty in this quarter. I think it's just everybody is chasing the same product with aggression, either sitting on inventory, the flu season not playing out the way it was supposed to. There's just too much inventory in the system and either we can behave irrationally in that process or we can just stay put with our strategy. I think that's what we've done. Like I said in my opening, we had sight of the transaction with Endo, that gave us a lot more flexibility to take some strong positions with certain price drops.

I think the new portfolio will ensure that we should get back to a healthier gross margin than what we reported. This will pan out only in Q3.

Nitin Agarwal
Analyst, DAM Capital

Right. On the portfolio that we talked about, we talked about going back to meeting our $400 million revenue aspiration over the next 24 months. The $400 million was essentially under a different strategy and with a much larger portfolio coming on board, does that end goal for the business change now from a size perspective?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

One is that obviously the strategy of the $400 million, if you recall when we articulated the strategy, said that we needed 70-80 products to get there. Almost 100 products is what we mentioned, an average revenue of [inaudible] $4 million. All we are saying is that we have now secured that portfolio. It's not normal for us to launch every single product. I think between our portfolio and the portfolio of the products that need to get approved in the next year, we are now very confident of achieving our first phase goal of $400 million. We have also mentioned in today's commentaries that we are now reallocating R&D from a generic portfolio to more specialized portfolio, and that should lead our phase II growth of what we want to be.

We would be able to articulate this a lot better with our Q3 results.

Nitin Agarwal
Analyst, DAM Capital

Got it. If I can take one last one on that. On the portfolio, so we said there were 100 odd sort of products which are complementary products in the portfolio that you acquired, and there are 20 commercialized products. 80 are what? To be approved ANDAs or these are products which are approved but not commercialized?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Every product is approved except two which is in the process of being approved.

Nitin Agarwal
Analyst, DAM Capital

Okay, these are products which are approved but not launched yet, which we can bring to the market.

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

For whatever reason, because Endo, as you know, has moved the strategy from generics which they announced in 2020. They progressively decided to move out of generics and keep only some special products which fits their brand strategy.

Nitin Agarwal
Analyst, DAM Capital

Okay. Thank you.

Operator

Thank you. We have the next question from the line of Karan Rathod from AUM Advisors. Please go ahead.

Karan Rathod
Analyst, AUM Advisors

Hello. My question was regarding ranitidine. We saw some news that again it may be approved for usage. Does that in any way affect us? Will we be again looking to relaunch that in the next few quarters?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

On ranitidine, it's different for different geographies. We are certainly looking at and we are engaging very closely with regulatory agencies in different parts. For example, we are engaging with agencies in Australia to see if we can get an approval. We are engaging with agencies in Europe to look at what their outlook is, and we are engaging differently in the U.S. U.S., of course, is a bit more stringent in what they have asked about the product, given their view of the NDMA content, and that's something that will take much longer time. While we continue to understand that landscape better and understand the expectations from FDA, which we started reviewing, we are engaging into very detailed conversations in Australia and Europe, and if there is some positive clearances that comes in, of course that's a product that we'll certainly look to maximize.

Karan Rathod
Analyst, AUM Advisors

I meant in the U.S., I thought there was some announcement that the NDMA thing was nullified by some judge and certain manufacturers were out.

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

That has to do with the class action suit which has now been dismissed for generic companies. There's been studies now published saying that low dose of NDMA in ranitidine doesn't create any of the issues that led to the decisions that the FDA took. I can not read the industry, but surely we will appeal to see what is their status on that. It's very early days. These are recent events.

Karan Rathod
Analyst, AUM Advisors

Okay. Thank you.

Operator

We have the next question from the line of V.P. Rajesh from Banyan Capital. Please go ahead.

V.P. Rajesh
Analyst, Banyan Capital

Hi. Thanks for the opportunity. Am I audible?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Yes, please.

V.P. Rajesh
Analyst, Banyan Capital

My question was regarding Stelis. What's the plan to realize the value for us shareholders in that asset? Will it take two years before it gets listed and then we do a deal of this? Is there some other plans you can just share some thoughts on that?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Well, at this time, we do not have any specific idea. We just have a new board with Aditya Puri becoming the chair. We will be engaging with bankers in this quarter to figure out what's the best value that we can get for the business, like sell it. We'll keep you posted of developments, but at this stage, we are looking at all options.

V.P. Rajesh
Analyst, Banyan Capital

Understood. Okay. The second question is regarding our main business. Like other participants have asked, I'm just trying to understand that is there something structurally different happening in the U.S. market which is going to be an impact on our business for the next several quarters, or it was what is just one quarter or two quarter issue?

Ananth R.
Managing Director and CEO, Strides Pharma Science

Yeah. As I said, I again want to split this across the two core business areas. As far as the other Regulated Markets is concerned now with U.K. opening up, as well as our manufacturing facilities returning back to normalcy and supporting the partnered order book that we always have visibility for, we clearly see bounce back coming in quarter two, and that is certainly a element that we did have a bad quarter one, but we will come back in quarter two and continue on the growth momentum there. As far as the U.S. is concerned, this has significantly impacted on our portfolio with the price erosions that we've never seen before. Given that we will close the transaction in the next 60 days, the Endo portfolio will play out for us in the H2.

From Q1 to Q2 will continue to remain a softer Q2 for the U.S., and from thereon we'll pick it up as we get busy in H2.

V.P. Rajesh
Analyst, Banyan Capital

What I was clarifying is that what you're saying is that Endo portfolio will make up for all the price erosion that we have either experienced in Q1 or are experiencing in Q2. Is that sort of the right way to understand that?

Ananth R.
Managing Director and CEO, Strides Pharma Science

It's the significant number of products there. Products that are in the niche area with lower competition and therefore better margin profile. As that kicks into play, obviously it is going to help compared to the existing, more acute solid dose product portfolio that we have, where we've seen a high erosion. Will this price erosion be sustainable? We do not believe so, but at least we need to be prepared over the next several months or into quarter two as well. While we believe it's not sustainable at this level, what will help us is the portfolio from Endo, which is lower competition with a better basket that will make a significant help for us in stemming that issue.

V.P. Rajesh
Analyst, Banyan Capital

Okay. Sorry, just one more follow-up question. I want to make sure I understand this correctly. When you're talking about 10% growth for the financial year over last year, are you assuming that you will have benefit of prices coming back plus the Endo portfolio or just the Endo portfolio?

Ananth R.
Managing Director and CEO, Strides Pharma Science

Could be a combination of the two that we expect. As we move into Q3 and Q4, the combination will help us get to that level.

V.P. Rajesh
Analyst, Banyan Capital

Okay. Your view is that the pricing that you are currently experiencing in the U.S. is abnormal and it is probably inventory dumping by one of the competitors in some of your products. Is sort of the way to understand this issue?

Ananth R.
Managing Director and CEO, Strides Pharma Science

Yes that is true. Hence that will also have a normalization.

V.P. Rajesh
Analyst, Banyan Capital

Understood. Okay. Thank you very much. Really appreciate it. All the best.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Thank you.

Operator

Thank you. We have the next question from the line of Mithun Soni from GeeCee Investments. Please go ahead.

Mithun Soni
Analyst, GeeCee Investments

Hi. Just a couple of questions. You said in your remarks, you did let go some of a business in the U.S. Could you like quantify how much you would have let go?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

We let go in the U.S. almost about $20 million of revenues. $ 15 million-$16 million of revenues in the quarter, because we've never had a quarter that's been $15 million in a long, long time.

Yeah. It is in that range.

Mithun Soni
Analyst, GeeCee Investments

You're saying about $15 million of revenue you let go during the quarter?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

That's right.

Mithun Soni
Analyst, GeeCee Investments

Yeah. Second question on that, with respect to you also said the price erosion, wanted to clarify, you said price erosion was much more in the products which were launched recently, right? Or was it more in the old product what we already have?

Ananth R.
Managing Director and CEO, Strides Pharma Science

It's a combination. One set of products that is at the bottom of our pyramid, which is the large volume products, had significant erosion, which we believe again, is with competitive intensity kicking in for that basket and probably inventories playing out there. On the second one was product that we launched in Q4 also had impact, which did not play out to our plan, where we saw significant price erosion and competitive intensity.

Mithun Soni
Analyst, GeeCee Investments

Okay. My question on Endo is that.

Ananth R.
Managing Director and CEO, Strides Pharma Science

That was more for a delta from Q4 to Q1.

Mithun Soni
Analyst, GeeCee Investments

Got it on that. Yeah. With respect to Endo, the production of those 20 products are already being commercialized in the market, right?

Ananth R.
Managing Director and CEO, Strides Pharma Science

Correct.

Mithun Soni
Analyst, GeeCee Investments

And.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Are currently being manufactured as well.

Mithun Soni
Analyst, GeeCee Investments

We will ship the production where for us?

Ananth R.
Managing Director and CEO, Strides Pharma Science

We will continue manufacturing there. All the products that are coming in as a part of the basket are all manufactured out of the Chestnut Ridge facility, and therefore much easier for us to continue manufacturing from that same facility.

Mithun Soni
Analyst, GeeCee Investments

Got it. Would you be able to give a number, like what is the revenue of those products as of now?

Ananth R.
Managing Director and CEO, Strides Pharma Science

We cannot. Until closing, obviously we cannot get into those details. Once closing is done.

As we get into Q3, we'll be able to be a little bit more specific on the Endo portfolio.

Mithun Soni
Analyst, GeeCee Investments

Perfect. Okay. Thank you very much.

Operator

We have the next question from the line of Rahul Bharadwaj, an investor. Please go ahead.

Rahul Bharadwaj
Individual Investor, Private Investor

Hello. Thank you for the opportunity. I hope you guys can hear me.

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Yes.

Rahul Bharadwaj
Individual Investor, Private Investor

Okay. My question is on Stelis. If you can provide more color on any contracts, new contracts on the vaccine front that Stelis may be getting. Secondly, on the approvals, I believe we had filed for some approvals in the EU related to on the biologic side. If you could share more information on this, that would be much appreciated.

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Yeah. Stelis, it's a thing that we have now invested heavily in the vaccine capabilities. We are soliciting other partners. These are early days. We are working with other partners to see if we can bring in new contracts. We should have some updates soon. We continue to talk to other key players. In terms of the programs, we are now only awaiting inspection for our facility for potentially our first product approval to be approved in Europe. Unfortunately, since the plant is new, the European authorities, which normally would accept mutually recognized regulatory bodies to previous inspections, in this case, our files will get reapproved post a physical inspection of the facility, which is likely soon. Once that's done, we expect our first program to get approved in Europe.

I can also tell you that we have just received our phase I readouts on our insulin glargine, which has come out very successfully and has met all the primary endpoints. We are very happy with that and we continue to now take [inaudible] for our global filings. We are progressing as scheduled, on schedule on those programs.

Rahul Bharadwaj
Individual Investor, Private Investor

Got it. Thank you. One last question, and this is more in terms of very future-looking. Three to five years down the line, do you see Stelis operating as a separate listed entity or the likelihood of still being with Strides?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

I think it will warrant there are conversations around that clearly. How, what, the process and timing is the only factor for me to answer your point in that period, yes.

Operator

Thank you. We will move to the next question from the line of Nitin Agarwal from DAM Capital. Please go ahead.

Nitin Agarwal
Analyst, DAM Capital

Hi, can you hear me?

Operator

Yes.

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Yes.

Nitin Agarwal
Analyst, DAM Capital

The USPs, I guess, with the Endo transaction, which gets sort of played itself out now in a particular outline, is that very clear. Now on the other pieces of the business which are there on the ther reg market, has anything changed from a strategic perspective or it's just a blip and our strategy remains where it was and goes back and we sort of start resuming growth in a couple of quarters to back to the old trajectory?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Sorry. Nitin, we are already guiding in other regs that we'll bounce back in this quarter.

Nitin Agarwal
Analyst, DAM Capital

Arun, is there a synergy of the portfolio acquired to these other markets?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Yeah. We have global rights on the portfolio and there is significant synergies. We obviously may have to do some bridging studies and work around small minor tweaking to meet European standards. Yeah, the portfolio is extremely complementary for us and especially the controlled substances you can export from U.S. into parts of Europe. We are excited with the portfolio maximization possibilities around the Endo portfolio.

Nitin Agarwal
Analyst, DAM Capital

Thanks. On the institutional piece, we've talked about certain stuff around cost optimization, cost competitiveness in that portfolio to improve our competitiveness. Can you just throw some more light on that in terms of what are we looking at in the institutional piece? Are we looking to have much larger ambitions on the business now versus what we had earlier?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Yeah. Nitin, we can. You see our largest challenge obviously is that because we do not make the APIs ourselves, unlike the fully integrated players, we have now managed to completely rearrange our supply sources from newly approved WHO-approved sources, and we are now in a strong position. As you know, these centers goes through a cycle, but we are in a strong position to become a cost leader in this program. You will see those results. It takes about two quarters for us to get significant velocity up. We have now completed all the work that is required for us to get into that position to bid and secure more contracts. I think this business will bounce back to the historic 2015, 2016 numbers where we phased to do close to $150 million-$200 million.

I think we are in a good situation with this business from next financial year, but you will see improvements starting from Q3.

Nitin Agarwal
Analyst, DAM Capital

This would largely benefit the TLD part of the business or there are more components of the business beyond TLD?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

TLD is about 70%-80% of the total value ascribed to the entire business. We need to solve for that. All of these products have a limited span of five to six years to be fashionable as a cocktail. We are now investing in what we potentially think would be the newer range of products that we need to stay invested. We are investing in R&D, considering that we can refocus a little bit on the U.S., given that we have enough portfolio to launch for the next two years. We would refocus more of our capital and resources around these businesses to grow.

Nitin Agarwal
Analyst, DAM Capital

Just to sort of complete that, where does it leave the Africa piece in the overall business now?

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

The Africa business is the only business that did well in the last quarter. There's growth. It's suboptimal in scale, but continues to be strategically important for us, and we'll stay invested and grow that business from here.

Nitin Agarwal
Analyst, DAM Capital

Okay. Thank you.

Operator

Thank you. Ladies and gentlemen, we will take one last question from the line of Alankar Garude from Macquarie. Please go ahead.

Alankar Garude
Analyst, Macquarie

Hi, thanks for the follow-up. Two questions from my side. With 100 compliant ANDAs, would the federal program be a meaningful contributor towards the $400 million target in the U.S. in the next two years?

Ananth R.
Managing Director and CEO, Strides Pharma Science

Yes, it should. This will certainly be a meaningful participation for us.

Alankar Garude
Analyst, Macquarie

Understood, sir. The other question, sir, is, if you look at our overall portfolio, it is still heavily skewed towards generics and regulated markets. Are you comfortable with the current revenue mix, or would there be any significant focus in the future on increasing our branded and emerging market presence?

Ananth R.
Managing Director and CEO, Strides Pharma Science

Certainly on, as Arun just mentioned in the previous question, we will certainly look to augment our portfolio, both on the branded and the next regime of the newer products for the ARVs. That's one. Also, we will refocus our R&D to also complex products and specialty products.

Alankar Garude
Analyst, Macquarie

Over the next few years.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Yes.

Alankar Garude
Analyst, Macquarie

The complex and.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Okay.

Alankar Garude
Analyst, Macquarie

Okay sir. Thanks and all the best.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Thank you. Thank you all.

Operator

Thank you. Ladies and gentlemen, that was the last question. I would like to hand the floor back to the management for closing comments. Please go ahead, sir.

Ananth R.
Managing Director and CEO, Strides Pharma Science

Thank you all for participating. Again, if there are any specific questions or any further discussions that need to be done, we're more than happy to answer questions. Please reach out to the Investor Relations team, and have a good day.

Arun Kumar
Founder and Non-Executive Chairman, Strides Pharma Science

Thank you. Bye, everyone.

Operator

Thank you, gentlemen. Ladies and gentlemen, on behalf of Strides Pharma Science Limited, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.