Strides Pharma Science Ltd

NSE:STAR

Earnings Call Transcript 2024-Q4

[Operator]

Ladies and gentlemen, good day, and welcome to Strides Pharma Science Limited Q4 FY '24 Earnings Conference Call. [Operator Instructions] Please note that this conference is being recorded. I now hand the conference over to Abhishek. Thank you, and over to you, Abhishek.

[Abhishek Singhal, executive]

Thanks. A very good afternoon, and thank you for joining us today for Strides Earnings Call for the fourth quarter and full year ended financial year 2024. Today, we have with us Arun, Founder, Executive Chairperson; and Badree Managing Director designate to share the highlights of the business and financials for the quarter.

I hope you have gone through our results release and the quarterly investor presentation, which have been uploaded on our website as well as 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 risk pertaining to our business. After the end of this call, in case you have any further questions, please feel free to reach out to the Investor Relations team.

I now hand over the call to Arun to make his opening comments.

[Arun Kumar, executive]

Thank you, Abhishek, and good afternoon, good evening to everybody joining us today now for our earnings call. It's been -- it's an honor to talk to all of you, especially on completion of what FY '24 has been an exceptional year for Strides. We came back strongly from a difficult FY '22, announced publicly a reset strategy. And I'm very delighted to announce today that not only have we completed all what we aim to achieve in our reset, we have done most of those much ahead of time, and we are now very delighted the way we are now positioned for future growth.

It's been a pleasure leading this company. We have made some announcements today, which we will talk briefly. I continue to be the executive chairman of the company and I will be on all the calls going forward. But having said that, we are building the future Strides for the next decade. And I'm delighted to have with me today, Badree, who's been a long-standing CFO and Executive Director, as our MD designate, and other colleagues in the room who could address some of the questions.

Overall, it's not often that the company gave guidance or an outlook with it because we were operating under difficult circumstances. And we continue to do that for the next year because we have Onesource announced. So it was important that we guide investors of where the business is going.

So if you look at the FY '24 performance, this has been our highest -- this has been our best year, both for revenues and absolute EBITDA. So also in the best quarter. We have been very, very focused on optimization of our business on cost containment, operation -- OpEx leverage and also growth.

It's been a very pleasant outcome. Like I said, we've had -- we have achieved all our outlook including debt, far ahead of our scheduled 3x debt-to-EBITDA ratio to close that by the high end range of the EBITDA that we achieved. And of course, we have also completed our network optimization across the company. We now believe the reset and the cost-effective strategies have been complete.

Growth investments started a few quarters ago. And you will see a very different Strides with product profiles and approvals in the next year or so. We are obviously delighted with a very critical approval this morning that we received for the U.S. [indiscernible]. We're also happy that it just adds to our basket of over 35 products that we are almost the sole Indian player.

This strategy has played out for us for many years, but we have now recently started adding products of larger value and size. We're delighted with our market share with Suprep. We have been a very quick 2 market player in that product, which is very contrary to our strategy of launching products at a very appropriate time when we get the right price and we are sure of the right market share. That strategy will continue.

And I will now briefly take all of you through some of the highlights. Revenues were shared under $500 million but all markets grew. Our key focus market -- new growth markets have grown exceptionally well. Most of you know that we have a small business in the institutional segment. That business has impacted in the last financial year by low allocation of tenders. This resulted in kind of muted performance in FY '24, but I'm now pleased to announce that we have to see a significantly higher allocation on this program for the next 2 years and you'll see more upticks in this part of the business in the second half.

Importantly, we have [Audio Gap] we have secured very significant product approvals. So I am guiding the investors and analysts and individuals who follow us to note that FY '25 will have -- will continue to be an important year but significant growth will come only in H2 because a lot of new product approvals and launches are expected only in that period.

What is also important for us in the last 2 years was consistency. And unlike our first half though, we have consistent quarters of revenues. Gross margin was very, very, in a tight space between 50% and -- 59% and 60%. This is almost a 12% uptick from where we started. EBITDA margins, nicely moving up from 16% to 19.3%. We would like to get to our historical 21% EBITDA in the next year or so, and there's some more work that is happening that will ensure that we get that. And adjusted PAT has been increasing steadily, and we have a PAT of around INR 200 crores after loss pickup of Stelis, and that is something we can discuss later. But Stelis supported its first-ever quarter where it had a breakeven as we guided.

We expect Stelis to be profitable part -- the division to be profitable in this financial year with all the business that we've won and we continue to win in that space. I'll come to that in more details.

But quick high levels, the U.S. market. We guided for $250 million at the higher end of the outlook. We are very delighted to be bang on target. We had a very weak flu season. Most of you know that we -- Q3 and Q4 are very significant quarterly markets because of flu products, but it was a very poor year for flu for us. But we were fortunate to have Suprep -- generic Suprep launched during this period. And we are now in full position with market share on this product that the contracts that we won. So we're very happy that some of the -- some of that negativity on the negative offsets on flu products were made up by new product launches.

Also, we have a lot of products approved. Our calibrated approach to pricing, market share, right time to launch is what we will continue. And we have guided that we'll get to a $400 million size in the next 2 to 3 years. We believe the U.S. market will continue to be an important part of our business strategy. But with this disciplined approach, which is very differentiated with both products and go-to-market. I'm also pleased to let you know that we are now considered amongst the most compelling generic providers for reliability and we have a service level of 99%, which is considered to be gold standards in the industry.

So our focus has been on customer advocacy, right pricing, right availability of product. We have the lowest failure to supply. Now this is now sub-$200,000 for a $250 million business, which is the lowest in the industry. And we're very delighted with all the enablers that I've got about driving the U.S. business.

We'll continue with this focus. But let me also announce today that we have started investing very heavily on newer technologies and portfolio beyond the $400 million generic mark as we focus on more complex generics. We just announced a partnership for nasal sprays in controlled substances. We will have our first filing in this financial year. And the first 505(b)(2) will also -- will probably be filed somewhere middle of next financial year. And there will be several more activities in building a portfolio both by in licensing and partnering and also developing us.

So we are -- I mean, earlier, we did mention that we have 60 products that meet our criteria of margins. We continue to stay invested with that theory. But we take more time to launch those products and just to be sure that our disciplined approach is not compromised. We will continue to be -- and we also see a lot of stability in the U.S. market. So I think the timing is also fine.

As far as the other regulated markets, we have had 3 consistent, although the market grew by 19%, almost 20%. We had 3 consistent quarters of $40 million. To most of you who follow us, we build consistency before we focus on levering that. You will see similar numbers for the first 1 or 2 quarters in FY '25, but then you will see significant growth in the second half in the other reg markets as we have already partnered our products. But as you know, in Europe and other markets, it takes time when new partner products for a partner to launch products. Typically, our partners are global or national champions. And therefore, they take a little more time than normal if we were going to market.

Our access market, I mentioned that in my brief summary, but our growth markets are growing very nicely. It's grown almost by about 25%. And of course, on a low base, and that will continue to deliver very strong growth in the coming years.

We committed to debt to EBITDA under 3x. Pleased to announce that we are now 2.72x of the outlook. The scheme with Onesource enables us to push down debt of INR 300 crores into OneSource. And we had a very significant free cash flow of almost INR 700 crores, that means almost 95% of our EBITDA-to-cash conversion ratio. We now have one of the industry-leading [indiscernible]. And we'll continue focusing on these elements as we improve our free cash generation. We target to reduce our debt by an additional INR 500 crores. After spending almost INR 200 crores in CapEx this year, we do not intend to achieve any of this with new borrowings. Consequently, we are now guiding FY '25 for the debt to EBITDA under 2x.

Leasing of course, is the ratio, so our key balance sheet ratios. ROCE especially has grown. Our exit run rate at 15% is pleasing. We have a very ambitious targets around that. We have a gross [indiscernible] turnover of almost 5x that again, many of you will appreciate it's industry-leading. We'll continue to set our assets by smart product selection, technology and automation that reduces our OpEx cost.

So before I conclude on Strides and open the house for questions, a quick note on OneSource. We have now received the name OneSource as official to Stelis is now called OneSource. OneSource, on completion, after an NCLT process will be India's first platform CDMO. We have 40 unique logos day 1. We have 17 GLP partners, including several first-to-file and sole exclusive players who are our partners. We believe that we are in a very, very strong position with our capabilities in drug product devices.

Erstwhile, injectables business, the CDMO business and the soft gelatin business, the incoming 2 businesses into OneSource, and met 100% of its EBITDA of FY '24. FY '25 will be similar with very marginal growth and that is because we expect more product approvals in both these divisions only towards the last quarter of FY '25.

We are pleased to confirm the price that we have now received as of late last night, all our approvals including that from the SEBI for the scheme to now go on to the NCLT, and we will now commence our NCLT filing in the next couple of weeks and we will keep all of you updated on progress.

Before I hand over the -- I mean take questions, we have made some changes. We have 2 very significant directors who have played very important roles in our company, Mr. Bharat Shah and Mr. Sridhar, both Independent Directors retiring. Consequently, we are very delighted to announce today the appointment of Subir Chakraborty onto our Board. Subir for those of you who may know him, was very -- until very recently, the CEO of Exide and has played a very, very significant role in creating significant value there. With strong operational experience prior to his CEO role, we are all excited to have Subir onboard and benefit from his experience.

We will also add Aditya Kumar on to the Board. Aditya for full disclosure is my son. He's been in the company for the last 10 years, and he will join us as an Independent Director -- sorry, Executive Director. Both are obviously subject to shareholder approvals. Consequent -- and -- like I mentioned, while I continue to be the Executive Chairman and will continue to play a significant role in setting the next level of Strides, and I already announced my pleasure of having Badree as my colleague and Managing Director and CEO, Group CEO of the company.

I'm also very pleased to announce that Vikesh who started his career at Strides, grew up the ranks with his brilliance and execution capabilities to be our new group CFO, and I'm sure with this new changes and additions, not only will we add strength to what we have done in the last 2 years but we have building the future for Strides.

My apologies for a slightly longish introduction but given that we are a little bit exuberant with what we have done this part in our indulgence.

I think about the FY '25 outlook, that's on for completeness. We expect to grow 12% to 15%. Bulk of the growth will come in H2. We expect EBITDA margins to be about INR 950 crores to INR 1,000 crores. I did mention that we expect the soft gelatin business to be soft in terms of EBITDA and that is because we had 2 very big approvals in FY '24 mainly Ibuprofen and Cyclosporine where we are taking significant market share, and new product approvals are already expected in FY '26. But we still will do a small growth over the $25 million EBITDA that we achieved.

Consequently, the retained business will deliver approximately INR 750 crores to INR 800 crores of EBITDA, and we have that run rate already now. So we should be comfortable in growing that from the INR 800 crore exit run rate to about INR 950 crores to INR 1,000 crores.

We expect free cash to be continuing to be a focus of the company. And we would end year with a net debt of 2x, and at which time we think that we would be in a very, very strong position to be debt free in 3 to 4 years from thereon.

We are guiding the U.S. business to be approximately in the range of $285 million to $300 million. It's a tight range but we are confident with approvals like Suprep and [indiscernible] today. These would still allow us to give away market share and we are challenged and yet grow the business without compromising the margins.

So thank you all, and happy to take questions.

[Operator]

[Operator Instructions] The first question comes from the line of Vishal from Systematics.

[Unknown Analyst]

With respect to the U.S., can you share some color on how Suprep is going for you in terms of market share? And have you scaled up to the full potential or is there further ramp-up possible here?

[Arun Kumar, executive]

So typically, Vishal in products like Suprep when there are 3, 4 players, we are very happy at the 25% to 30% market share. And I can tell you, as we speak, that we are at that spot already.

[Unknown Analyst]

Okay. So we should not see further ramp-up from Suprep going forward? You need new approvals to ramp up from here?

[Arun Kumar, executive]

We don't need new approval for Suprep, but we typically -- when it's a 3, 4 market player, we typically are satisfied with the 25% to 30% market share as a philosophy.

[Unknown Analyst]

And second on OneSource. We talked about a GLP-1 that is going to supply to customers. Is that GLP-1 already commercialized? Or it's in clinical status that you will be supplying?

[Arun Kumar, executive]

One of the GLPs, one of our partners have gone through is expecting approvals and we expect our first commercial supplies of GLP to commence in this financial year.

[Operator]

Next question comes from the line of Aman Vij from Astute Investment.

[Aman Vij, analyst]

Continuing this OneSource -- question on OneSource. So this CSA, we have gotten for GLP-1, it's for liraglutide, if my understanding is correct. And this -- if you can correct me on that, if I'm wrong. And this is expected to come in H2 or in H1?

[Arun Kumar, executive]

H2 and the product is correct.

[Aman Vij, analyst]

Okay. So we have like 15, 16 different projects. And out of this, only one CSA you are expecting in FY '25, not more than one? Or just...

[Arun Kumar, executive]

Our work on GLPs are on [indiscernible].

[Aman Vij, analyst]

Yes, Sir. But I believe we have 6 in...

[Arun Kumar, executive]

Yes, and they are all patented to '26.

[Aman Vij, analyst]

Yes, I believe we have 6 in liraglutide? Only one of our customers are commercializing this year, rest maybe in FY '26.

[Arun Kumar, executive]

I do not know where you get this information. We do not give how many customers for each programs in any of our conversations.

[Aman Vij, analyst]

Sure, sir. You have shared all this information one of the PPT. So just wanted to clarify on that part. Anyway, on...

[Arun Kumar, executive]

We have one customer who's expected approves. We may get every other customer's approval still, but one customer has already started work on the commercialization of...

[Operator]

[Operator Instructions] Next question comes from the line of Nitin Agarwal from DAM Capital.

[Nitin Agarwal, analyst]

Congratulations on a very strong finish to the year. Two questions. One is on the U.S. business. The point that you mentioned about -- so our intent to grow the business beyond $400 million in terms of some of the newer activities that you're trying to get in. How are you -- how should we think about our U.S. business evolution, it gets to $400 million the next 3 years? And then how do we see it going from thereon?

[Arun Kumar, executive]

So what we're saying is that the current strategy of niche limited competition kind of limits our growth to $400 million. That's our aspirational growth. We are now very confident we can achieve that. Maybe we can add a few tens of millions of dollars additionally, but it's not something that can double from $400 million.

For us to continue to benefit from the U.S. market opportunity, we have to be differentiated with either a platform technology or leveraging our U.S. manufacturing activities, which has got very specific capabilities around control substances, laser space, very complex device liquids manufacturing, which can only be made in the U.S.

And that requires capabilities, which are currently beyond what we have in India. And that is what we are currently investing globally with partners and sometimes we do it ourselves, both here in India and more in the U.S. eventually. And that set of products are typically in the $40 million to $50 million opportunity range.

So from the evolution standpoint, you'll notice that our original strategy in the U.S. was when we had a $3 million to $4 million product average. The last few approvals have taken that ticket up to an average of $20 million. And now we are building portfolios in the $40 million to $60 million range.

So it's been a kind of -- it's not tactical, but a more stated strategy that is just playing out and it takes it us time payout.

[Nitin Agarwal, analyst]

And secondly, on the other end markets, we've been actually very positive on this space. Is there any -- are there any particular reasons why the traction has not been as much as you probably expected at the start of the year?

[Arun Kumar, executive]

No, it's still grown at 20%, but it's important to note that our other regulated market is almost B2B, right? So when we license our products to global players, it takes time for them to launch the product because they typically launch in 20 -- 15 to 20 countries at the same time. And therefore, the launch period is much longer. And that's about it. Like I said, in H2, you will see these numbers changing quite significantly upwards.

[Nitin Agarwal, analyst]

Okay. And lastly, on OneSource, the drug device play out -- I mean, will begin to play out that part of the business. A liraglutide starting off and then semaglutide as and went which expire. The other pieces of the business, especially around biologics CDMO, I mean, how should we think about that piece in terms of how that will evolve in terms of scalable and size as we go through?

[Arun Kumar, executive]

So we are winning. So as you know, our drug substance capability is really established about 6 months ago. I'm now actually pleased to report that we have won our first major NCE contract there. And we keep winning business. So we are adding new customers every month across the platforms.

Of course, everybody is excited about the GLPs, but our focus on non-GLP is as intense as it should be for a CDMO. So we are winning a lot of business in non-GLP programs too. Overall, we have guided $400 million of revenues 3 years from the time of listing of OneSource if I'm not mistaken in the last updates. We are very much on track to get there, both the GLP and non-GLP programs.

[Operator]

[Operator Instructions] Next question comes from the line of Praful Bohra from InCred Capital.

[Praful Bohra, analyst]

Congratulations. Arun, just 2 questions on the U.S. business. So first, the guidance of $285 million to $300 million, which is around 15% to 20% growth. So here, what kind of price erosion are we building?

[Arun Kumar, executive]

Well, the U.S. business is not a function of price erosion for us is that when we are challenged heavily, we exit the product. So we just get off a product. And if you look at IMS, you'll see us not in products that we were there last year if we are being challenged on pricing.

So we don't have -- so because we have the luxury, Praful of several aim is that it's at the cusp of being launched. We have a very differentiated way of modeling our U.S. business. And I have been consistently telling for 4 years that we do not have a price erosion. For this reason, not because we are not challenged but when we are challenged, we let go. I mean rational challenge we keep. Irrational challenge, we let go.

[Praful Bohra, analyst]

Sure. And secondly, on the endo portfolio, what proportion of the pending ANDAs are still liable to launch? And would any of the ANDAs be significant from our perspective?

[Arun Kumar, executive]

Yes, of course. Our #1 selling product now is an Endo product -- I mean, Endo portfolio product. So we probably have one more product that we will launch this year from the Endo portfolio, which will have an exit run rate almost similar to our #1 product. We now -- the Endo itself is profitable. P&L after 2 difficult years and a significantly profitable P&L on a stand-alone basis.

We have a lot of products. I would say 10, 15 products at least on the Endo portfolio that will meet our criteria. But these products in the U.S., we are constrained by the speed in which we can launch these products because we only have the capacity to launch 3 or 4 new products a year. And we then pick and choose which are the best ones in a lot. But like I said, our #1 product in the U.S. now it's an Endo product erstwhile.

[Operator]

Next question comes from the line of Aditya Sen from RoboCapital.

[Aditya Sen, analyst]

So we have guided about 12% to 15% growth this year. So that is inclusive of all the product launches that we are planning, right?

[Arun Kumar, executive]

Yes.

[Aditya Sen, analyst]

So this will -- the guidance will be same for FY '26 and '27, if I'm not wrong.

[Arun Kumar, executive]

That would be the same.

[Aditya Sen, analyst]

Because we have around 60 product launches scheduled for the next 2, 3 years, 3 years. So we...

[Arun Kumar, executive]

Our product is not equal to revenues, right? A product can be $4 million, a product can be $20 million. So that's not a good benchmark for you to do our model. We have guided $400 million over the next 3 to 4 years. We are growing at 15%. If you continue doing that, we'll do that in 3 years, right? The math is very simple. .

[Aditya Sen, analyst]

And also in OneSource, can you please mention how are we planning to achieve such targets? Will it be again product-driven? Or do we have other strategies there?

[Arun Kumar, executive]

So we already have contracts signed, right? So we only need our partners to get approvals.

[Operator]

Next question comes from the line of Rupesh Tatiya from Intelsense Capital.

[Rupesh Tatiya, analyst]

My first question is, can you please tell me what is the capacity for GLP-1 across OneSource...

[Arun Kumar, executive]

Can you just speak up. Your speaker phone or something. We can't hear you well.

[Rupesh Tatiya, analyst]

Hello? Can you hear me, sir?

[Arun Kumar, executive]

Yes, better.

[Rupesh Tatiya, analyst]

Okay. Sir, my first question is what is our capacity for GLP-1 across OneSource network, manual injectors, auto injectors. I mean if you can give some color on that.

[Arun Kumar, executive]

The right combinations of about 40 million unit capacity, and we will complete an expansion in FY '26 to take it to 200 million units. .

[Rupesh Tatiya, analyst]

And this 40 million, what kind of gross block it is? And what kind of revenue it can generate?

[Arun Kumar, executive]

We can't get into those details. You can send us a note, these are 2 granular details to give them an investor call. And we can then respond to you specifically.

[Rupesh Tatiya, analyst]

Okay. Okay. Sir and then I also wanted some color in how does the billing work in this GLP because we are going to create a final drug device, but the drug comes from our sponsor and the device will come from somebody else. So how does the billing box in this?

[Arun Kumar, executive]

Our revenue of CDMO is 100%, everything else is part through. Our partner pays for everything. We only serve -- when we say our revenue could be $300 million or $200 million in the biologics division, not in the soft gel and injectables division. Then if you do $100 million in biologics, $100 million is our gross margin.

[Operator]

[Operator Instructions] The next question comes from the line of Sandeep Dixit from Arjav Partners.

[Sandeep Dixit, analyst]

Can you hear me clearly?

[Arun Kumar, executive]

Yes. .

[Sandeep Dixit, analyst]

Just wanted a clarification. In your opening comments, one of your sentences after you mentioned the guidance of EBITDA close of INR 950 crores to INR 1000 crores. Did you give any guidance for the standalone entity or other the retail business in Strides?

[Arun Kumar, executive]

INR 750 crores to INR 800 crores.

[Sandeep Dixit, analyst]

Right. Sir in which case, the numbers are not adding up. That's the reason I ask. You have said $60 million as the guidance for once it was...

[Arun Kumar, executive]

You are not reading our deck properly, Sandeep. The $60 million has got 3 divisions. Growing from Strides is $25 million. What is going from Strides is $20 million, okay? That's all -- from other parts which are getting merged. .

[Sandeep Dixit, analyst]

Right. Perfect.

[Arun Kumar, executive]

INR 950 crores to INR 1,000 crores, you have to only minus $20 million.

[Operator]

Next question comes from the line of Nitin Agarwal from DAM Capital.

[Nitin Agarwal, analyst]

Arun just clarifying, you mentioned increased capacity for the drug-device combination to be $100 million or $200 million?

[Arun Kumar, executive]

$200 million.

[Nitin Agarwal, analyst]

Goes almost 5x?

[Arun Kumar, executive]

Yes, we were taking off $100 million within when we spoke 3 quarters, but we currently with the contracts that we have signed up and looking at the success of some of our partners in the litigation and for position status. We are obliged to double our capacity to $200 million. So yes, we're going 5x and we'd rather do it at one go because equipment cost is not the most expense. I mean, is the most expensive part, but the lead time for equipments are too long in this.

[Nitin Agarwal, analyst]

And where does it place you in terms of rather with this capacity in the various drug device CDMO players?

[Arun Kumar, executive]

We do not have specifics of our competitive landscape, but I would assume top 5.

[Nitin Agarwal, analyst]

Okay. Okay. And secondly, on a Strides business, you've done a pretty decent job on controlling our overhead costs, optimizing our cost structure, the whole last several quarters. I mean, do you still see opportunities for optimizing the costs further from here on, leading to further expansion of margins over the next 2, 3 years?

[Arun Kumar, executive]

Well like I said, Nitin, we probably have about 200 to 250 basis points of margin expansion through cost improvements and completion of network optimization. And that is why we said our dream goal is to get to our 21.5% peak EBITDA percentage-wise. And we think we can do that in the next 12 to 16 to 18 months.

[Nitin Agarwal, analyst]

Okay. And with the strategy that we're following in the business, what is your assessment of the soft gelatin business or sort of a peak profitability of this business can really get to?

[Arun Kumar, executive]

So I think minus OneSource also, we can comfortably grow at that 15% CAGR and a target then should be to get to 21% EBITDA and be debt free. This is our goal in the next 3 years.

[Operator]

[Operator Instructions] Next question comes from the line of Rohit M., an individual investor.

[Unknown Attendee]

First question is on the other regulatory business -- yes. So first question is on the other regulated business. We had a strong year for the other regulated [indiscernible]. Could you highlight which were the key markets that contributed to the strong growth? And are we confident of maintaining this growth momentum going forward in the next year.

[Arun Kumar, executive]

Yes mainly Germany and Australia and the Nordic regions.

[Unknown Attendee]

Sorry and any guidance on the next year?

[Arun Kumar, executive]

We can't give a percentage guidance, but we said that the company overall grows 12% to 15%. ORM will continue to be a big part of that growth. But more growth you will see in H2 rather than H1.

[Unknown Attendee]

Now second question is on the gross margins, which were around 60.7% in the Q4. Can you sustain this 60% gross margins going forward? And how are we looking at that?

[Arun Kumar, executive]

Yes, plus/minus 2% is [indiscernible]. So we have done that for 4 quarters or more. So we can -- we are now in that zone. We should not have a problem.

[Operator]

[Operator Instructions] Next question comes from the line of Jagdish Sharma an individual investor.

[Unknown Attendee]

Congratulations for a good FY '24. My question is on U.S. business. What kind of investments will be needed incrementally to take over your business to $400 million in the next 2 to 3 years?

[Arun Kumar, executive]

Nothing. We have all the products already approved. We have 265 plus ANDAs, of which we have commercialized only 55. So we have plenty of ANDAs. Our R&D for the $400 million run rate is almost done. We don't spend any money on that part of the business. We'll put more money on the $400 million beyond story.

[Operator]

Next question comes from the line of Rahul Bharadwaj an individual investor.

[Rahul Bharadwaj]

And congratulations on a good set of numbers.

[Arun Kumar, executive]

Rahul, can you speak up?

[Rahul Bharadwaj]

Yes, sure. Could you share a bit more guidance on possible demerger situation for OneSource and the vision that we have over the next couple of years for this particular division and how we [indiscernible] division?

[Arun Kumar, executive]

You need to repeat your question on OneSource.

[Rahul Bharadwaj]

Yes. Any details that you can share in time line for the demerger and how we plan to grow in the CDMO division over the next couple of years?

[Arun Kumar, executive]

So we got last night, the demerger approvals from SEBI, which was the last step prior to the court process of the demerger, which is called the NCLT process. We expect to file filing code, the necessary documentation this quarter. Typically, it can take anywhere from 3 to 4 quarters for the court process to get completed and about 60 days for the stock exchanges to list the stock. But because that's the last and most important step was the stock exchange approvals and SEBI approvals, which came in last night.

[Operator]

[Operator Instructions] Next question comes from the line of Vibha Ravi with Citeline.

[Vibha Ravi, analyst]

Could you tell me as OneSource can be expected to benefit in any way from shift away from certain Chinese companies like Wuxi? I know still time for the bio secure act to who will come through. But is there any planning on that front? And can one or we expect it to benefit?

[Arun Kumar, executive]

So clearly, the Biosecurity Act has been diluted quite significantly and there is a 7- to 8-year window for companies depend on China to find solutions or alternative solutions. But we are seeing significant amount of new RFPs for biologics. And I think the China Plus One on the biologics is playing through.

We are -- we haven't seen so many RFPs in the last 1 year that we have seen in the last 2 quarters. So we believe that there is some momentum around this Biosecurity Act and at least new programs coming to India or in other nation as a first choice. To answer your question in simple, yes, we are seeing that. We are seeing benefiting Stelis or OneSource.

[Vibha Ravi, analyst]

Okay. And one more bit broad-based question. So is the Middle East crisis expected to begin impacting input costs and for logistics any time soon or it's like further out?

[Arun Kumar, executive]

Lot on supply chain of materials because earlier it was more to do with geopolitical and COVID and other issues. The Red Sea crisis is now, I would like to say, behind. The shipping premiums have dropped quite dramatically. But yes, we -- this is the nature of the beast, right? So we have to be vigilant. For now, it's business as usual.

[Vibha Ravi, analyst]

Okay. And can I just get in one more question?

[Arun Kumar, executive]

Please.

[Vibha Ravi, analyst]

Could you talk a little bit about how the alliance with Orbicular for nasal spray is progressing?

[Arun Kumar, executive]

Progressing very well. It's one of our important partnerships. I did mention that we will have a first filing this year. We expect to complete into our platform program during the course of the next 12 months, and we should expect approvals thereafter. We have significant interest on these exclusive control substance programs and in partnership with Orbicular, we are finding the right go-to-market strategy. Yes, we are very excited that with our partnership publicly we consider them to be best in class and we're delighted to be partner.

[Operator]

Ladies and gentlemen, that was the last question for today. I would now like to hand the conference over to the management for closing comments.

[Arun Kumar, executive]

Thank you all, really appreciate your time, and thank you for your patience as we people at Strides, appreciate your time. And feel free right to ask if you have any questions. Thank you and good evening.

[Operator]

Thank you. On behalf of Strides Pharma Science Limited, that concludes this conference. Thank you for joining us. You may now disconnect your lines.