Biocon Ltd
NSE:BIOCON
If you don’t study any companies, you have the same success buying stocks as you do in a poker game if you bet without looking at your cards.
Utilize notes to systematically review your investment decisions. By reflecting on past outcomes, you can discern effective strategies and identify those that underperformed. This continuous feedback loop enables you to adapt and refine your approach, optimizing for future success.
Each note serves as a learning point, offering insights into your decision-making processes. Over time, you'll accumulate a personalized database of knowledge, enhancing your ability to make informed decisions quickly and effectively.
With a comprehensive record of your investment history at your fingertips, you can compare current opportunities against past experiences. This not only bolsters your confidence but also ensures that each decision is grounded in a well-documented rationale.
Do you really want to delete this note?
This action cannot be undone.
| 52 Week Range |
233.1
391.2
|
| Price Target |
|
We'll email you a reminder when the closing price reaches INR.
Choose the stock you wish to monitor with a price alert.
This alert will be permanently deleted.
Biocon Ltd
You don't have any saved screeners yet
Ladies and gentlemen, good day, and welcome to Biocon Limited's Q1 FY '19 Earnings Conference Call. [Operator Instructions] Please note that this conference is being recorded.I now hand the conference over to Mr. Saurabh Paliwal from Biocon Investor Relations. Thank you, and over to you, sir.
Thank, Ramon, and good morning, ladies and gentlemen. I welcome you to Biocon's earnings call for the first quarter of fiscal '19. We declared our [books] yesterday. I hope you had the chance to look at them. Before we proceed, I would like to remind everybody that a replay of today's discussion will be available over the next few days, about 60 minutes post the conclusion of this call. We will post the transcript of the call on our website in the coming days.Moving on, to discuss this quarter's performance and outlook, we have today with us Biocon management led by Dr. Kiran Mazumdar-Shaw, our Chairperson, and other colleagues from the senior management team.I would like to remind everybody that today's discussion may have forward-looking statements based on management's current views and expectations. They must be viewed in conjunction with the risks that our business faces that could cause our future results, performance or achievements to differ significantly from that what is expressed or implied by such forward-looking statements. After the end of this call, if you need any further information or clarifications, please do get in touch with us.With this, I would like to turn the call over to Dr. Kiran Mazumdar. Over to you, ma'am.
Thank you, Saurabh. Good morning, everyone. I Welcome you to Biocon's earnings call for the first quarter of fiscal year 2018/'19.Let me start with key highlights for the quarter. I'm pleased to share that our partnered biosimilar, pegfilgrastim, Fulphila, received approval from the U.S. FDA last month. Our partner, Mylan, has launched the product in the U.S. as the most -- as a more affordable therapy option for cancer patients undergoing chemotherapy. It is indeed a significant milestone for Biocon and sets the tone for the future success of our biosimilars business. Very few companies have received 2 biosimilar approvals from the U.S. FDA and we are very proud of this achievement. It makes us, as I said, the first company from India to get this biosimilar commercialized in the U.S., and we are certainly, as I mentioned earlier, the only company from India to have 2 of its biosimilars approved by the U.S. FDA.Biocon's sterile drug product manufacturing facility for biologics in Bengaluru received EIR from U.S. FDA and the EU GMP certification during the quarter. We presented PK-PD data on our Novel Insulin Tregopil at the American Diabetes Association scientific sessions in the U.S. And Syngene extended and expanded their agreement with the Baxter global R&D center until 2024. Now moving on, I will present the key financial highlights for this quarter.Total consolidated revenue for the quarter were INR 1,193 crores, up 21% compared to last year. Revenue from operations were INR 1,124 crores, which were up 20% as compared to last year. This includes licensing income of INR 5 crores this quarter as compared to INR 8 crores in Q1 of last year.From a segment perspective, Small Molecules, the segment revenue was up 10% to INR 400 crores. Biologics grew 36% to INR 250 crores and Branded Formulations grew 13% to INR 147 crores. Syngene revenues were up 39% at INR 406 crores in Q1.We incurred gross spend of INR 88 crores on R&D this quarter, corresponding to 12% of revenues, excluding Syngene. Of this amount, INR 44 crores is reported in the P&L. We capitalized an amount of approximately INR 44 crores related to our biosimilars and insulin analog development expenses. The gross spends are lower than last year due to timing of some of the activities on a quarterly basis. The amount in the P&L has reduced on account of capitalization of bevacizumab-related expenses, which were reflected in the P&L in Q1 of last year.We booked a ForEx gain of INR 39 crores this quarter as compared to INR 17 crores in Q1 of last year. This gain is reflected in the other income line of the P&L. Of the total amount, INR 28 crores is coming from Biocon while the rest is attributable to Syngene.Group EBITDA grew 25% to INR 307 crores, with EBITDA margins at 26%. Core margins, that is EBITDA margins net of licensing impact of ForEx and R&D, stood at 27%. Reported net profits were up 47% this quarter at INR 120 crores, which represents a net profit margin of 10%.The effective tax rate at 27% for the quarter is slightly lower than last year of 28% due to lower losses in overseas subsidiaries during the period under review.Coming to discussing individual business segments. Small Molecules. The revenue growth of this segment was led by key APIs and increased generic formulation sales. Higher sales of immunosuppressants and increased market share of Rosuvastatin formulation in the U.S. were key contributors. We also launched simvastatin tablets in the U.S. market during the quarter. Several drug multipliers were filed in developed and key emerging markets during the quarter, centering on Small Molecule's API pipeline.Now coming to Biologics. This segment was led by higher sales of biosimilar monoclonal antibodies in emerging markets, supported by the Insulin business. The primary driver for growth this quarter was trastuzumab with strong retail market uptake witnessed in Brazil and robust market shares in certain markets in the [ LATMEX ] region.Our Insulins portfolio continues to improve its market share in several emerging markets. Clearly, we are seeing a strong uptick of our biosimilars portfolio products in emerging markets and we can enjoy wide acceptance from patients and prescribers. With the strong start in the year and several regulatory submissions made in emerging markets recently, we expect a further pickup in the Biologics business growth in the coming quarters.The recent launch of pegfilgrastim by our partner, Mylan, in the U.S. and Insulin Glargine sales in EU and Australia, which are planned for later this fiscal, are expected to provide a further tailwind to this segment performance. We remain confident of achieving the $200 million target revenue for this segment in FY '19.In Q1, the growth in Branded Formulations segment, which comprises product sales in India and U.A.E, was led by growth in the India Branded Formulations business. The India business growth this quarter benefited from the lower base last year in the same quarter due to GST implementation. Metabolics, Nephrology, Immunotherapy and Comprehensive Care divisions aided the business performance with strong growth reported for some of our key brands.In the U.A.E., the business continue to garner market share in the Metabolics segment to increase sale of in-licensed products of our Insulin Glargine, which was introduced recently.In terms of research services, Syngene recorded a strong growth this quarter. The growth was driven by good performances within biologics manufacturing, discovery services and chem dev services. Syngene also announced the extension and expansion of their agreement with the Baxter global R&D center until 2024. They also announced the recommissioning of Phase I of the upgraded [ S2 ] facility, which was damaged due to a fire incident in December 2016. The progress made provides good visibility on underlying growth expectations for Syngene for this year and the long term.Now for some product development updates. In Europe, the regulatory review of our Marketing Authorization Applications or MAA for biosimilar trastuzumab and pegfilgrastim are progressing well, and we expect the decision by CHMP by the end of calendar year 2018.For the U.S. market, Biocon and Mylan are generating additional clinical data for Insulin Glargine in support of the manufacturing site change from Bengaluru to Malaysia. All activities, as agreed with the U.S. FDA in this regard, are progressing as planned. We will expeditiously provide the requested data to the regulator in response to the Complete Response Letter we received for this product. We do not anticipate any impact on the approval and launch timing of Insulin Glargine in the U.S.As part of our novel molecule portfolio development program for Insulin Tregopil, our oral insulin candidate. Insulin Tregopil advanced in pivotal Phase II, Phase III study in Type II diabetes with more patients in India being randomized during the quarter.Before I conclude, I would like to summarize our performance in Q1 FY '19 and the expectations for the rest of the financial year. We have had a positive start to the year with a good performance in the first quarter. We were able to increase sales in the Small Molecules segment despite challenges persisting in the generics industry. Branded Formulations also grew in double digits, and we expect a better performance from this segment this year. The growth segments, namely Biologics and Syngene, have made a strong start building upon the traction from last quarter. Recent and upcoming launches of biosimilars, coupled with traction in the research services, provide us a good launch pad to accelerate growth in the subsequent quarters during this financial year. We have positive expectations on our overall performance this fiscal.With this, I would like to open it up for question and answers. Thank you.
[Operator Instructions] The first question is from the line of Prakash Agarwal from Axis Capital.
Just trying to understand this R&D line better. You had earlier talked about a INR 4.5 billion to INR 5 billion kind of run rate. We are a tad lower as per the quarterly run rate is concerned. So how should we think about for the full year? Is there any change?
No change in the R&D guidance. So it would be in the range of INR 4.5 billion to INR 5 billion range. And as we have said, this is -- can be even towards the quarters. This quarter, at a gross level, it was at INR 88 crores. And we definitely expect the expenses to go up in the coming quarters.
Okay, great. And secondly, on Fulphila. Again, congrats on launching it as well. Just trying to understand this. In terms of ramp up, how should we think about the acceptance and the ramping up of the product? What are the initial fillers, if you could share?
Sure. I think certainly, we are looking forward to this launch. We're excited about this product going forward, and we look forward to seeing how it develops. I think it's too early to speculate at this time and -- about specific market shares that we're targeting.
Okay. And would the sales of Fulphila be recorded in the current quarter? I mean, Q1, there is some impact? I mean, I understand profit share will obviously come later. But would the manufacturing sales would have gone?
A very small number, Prakash. Not a big number. But yes, there is -- the launch quantities were included in this quarter's number.
Okay. And from here, obviously, a good ramp up mode?
Yes. And more importantly, the profit share would start coming as Mylan starts liquidating the inventory in the markets.
Would that -- quarter lag, sir, would that be right to understand?
Yes. I mean, that will be fair. But given the initial launch -- I mean the -- for the inventory, they maintain -- obviously, there will be no profits on that. But for the initial launch quantity, I don't think there'll be a big lag. So we will expect whatever initial sales they will do in the quarter 2, the profits will be captured in quarter 2.
Understood. Fair enough. And secondly on Glargine, just looking at clinical trials website. So it talks about completion of additional clinical data by December 18. So post which, in terms of time lines, we would be looking to submit the data and should we expect calendar '19 as the approval?
We have a litigation on this product and I do note this is on the 505(b)(2) [that came out] today, which expires in -- gets over in March 2020. So what we said is that we expect to get the approval before March 2020. And because of the litigation, and it is in the final approval, [indiscernible] overall the litigation and such.
Yes, yes. No, that I understand. Just understanding, with the clinical trial data being completed, would it be fair to see an approval by '19 is what I'm trying to understand?
No. Actually, that mentioned, the approvals having to be -- the whole 505(b)(2) packing litigation. The 13-month stay. So that's what's drive some of the [ clot ]. But from our side clearly, you can see that the trials are going on track, and with also in Kiran's opening remarks, we have guided saying that we are on track in terms of approvals and launch in the U.S.
Understood. Fair enough. And lastly on the cash pile, given we had some stake sale on Syngene, what is the cash position and the CapEx for the quarter, sir?
So it is roughly INR 2,100 crores with a debt of INR 2,500 crores. So the net position is roughly INR 300 crores. So the cash, what we collected from sale of Syngene stake sale was roughly INR 340 crores, and then we had a CapEx of -- at a group level of almost similar amounts. So compared to March, our cash position remains unchanged.
CapEx is around, sir, for the quarter INR 300 crores?
INR 340 crores.
Okay. This is for the full year. I'm asking for the quarter, sir?
I'm telling for the quarter.
Oh, INR 340 crores, okay, okay.
That's Mylan and Syngene combined.
The next question is from the line of Damayanti Kerai from HSBC.
Congratulations for launch of Fulphila in the U.S. So can you broadly indicate at what discount -- price discount [for this product] we have launched in the market?
Sure. I think it's been indicated in the press and Mylan has confirmed also about the 33% discount in the list price, the WAC price in the market. So that's the information available at this time.
Okay. Coming to Insulin Glargine, you have indicated that we have done really well in Brazil. But can you also indicate how we have done so far in Japan in terms of like what kind of market share or sales we have garnered so far?
So the -- in Japan, I think our launch there was after a prior launch of the biosimilar there. And so this has not been a big market for us so far, but we continue to watch and work with a partner to see how this evolves.
Okay. And final question from my side. Can you indicate how much R&D we have cumulatively capitalized so far?
Yes. Just give me a second. It's around INR 500-odd crores.
INR 500 crores cumulatively?
That's right.
Okay.
But that also includes the amount for internal capitalization as well as amount paid out to in-license the adalimumab molecule that Mylan partnered with FKB.
Sorry, can you come again on that. I couldn't get it. It's for internal capitalization, as well, what?
For any intangible that we acquired. So the total amount is INR 500 crores.
The next question is from the line of Surya Patra from PhillipCapital.
Congratulations for the launch of Fulphila in U.S. And sir, just on the ramp-up side for Fulphila, it would be very, very staggered or how it will be actually like for one [would clearly see]. And what is the likelihood of the competition there for Fulphila? What sense that you can provide?
Sure. We've seen different trajectories for different products in the U.S. market. And generally, there is a gradual ramp-up in the U.S. market with the biosimilar launches there. So that's the kind of the backdrop with other products that we'll be looking at in comparison to our launch. In terms of competitors, we are expecting Coherus, has their action date on November 3. So we do -- we know that one is on the horizon. Others are further -- are beyond that time, and I don't think there's as much specifics on their entry time.
Okay. Usually, it could be 1 to 2 years kind of scenario and with the similar kind of that initial price and what we have witnessed, could be sustaining for a little bit longer time? Is that assessment fair?
Sorry, can you repeat the question, please?
So that mean it could be initially selective very, very and less competitive kind of space with 30 -- 30% to 40% kind of a price discount scenario would be prevailing in the initial phase, sir?
Yes. I mean, I think the -- that initial WAC price discount had been announced, and that's what it is at this point. I think it wouldn't be appropriate to talk about the competitive strategy or speculate about how that evolves.
Right. And on the [indiscernible], the 2 products, which has already been, though it is our partner product, but in the meanwhile to accelerate [indiscernible] products in European markets for [indiscernible] adalimumab, Mylan has partnered with third parties. So how are the economic interest, sir, are getting protected? Can you just provide some idea about it? And so -- and also, what is the kind of progress that we are seeing for the balance of the pipeline?
So let me take the first question, and I think -- and then hand over to my colleagues to answer this pipeline -- but on the first question, what we've said is that whatever are the profits from these in-licensed products, Mylan will get -- will be shared with us in line with our original agreement. So for the developed markets, as you know, we have a profit share, which is different from emerging markets, and the same ratios would be applied to profits in the developed markets as well as emerging markets.
Okay. And this would be exclusive to Europe as of now, and U.S. plans will be with our own product only? That is how one should probably view this, sir?
Well, right now, Mylan has announced for Europe, and I can't comment anything more than that. For [indiscernible], I think, there are certain emerging markets also involved. On the development pipeline...
Surya, this is [indiscernible]. On the pipeline perspective, I think we've already guided on in terms of how our products are progressing, particularly on the clinical development of bevacizumab. We've progressed the molecule into Phase III global clinical trial, and we've also progressed that insulin analog as part as to the Phase I clinical studies, and that's we are at -- where we are at with that. And then there are a series of products which we've listed even in our annual report, which we believe will be moving to the clinical development as per our plan.
And with regard to Sandoz association, whether we have started [ R&D-ing ] cities on that front-end with the numbers relating to the R&D spend numbers relating to that have already been started putting into the [ P&L ] so far?
Yes. The numbers do include a very small component of Sandoz collaboration products R&D.
Okay. Just one more question around the simvastatin, though we have launched the product recently. And after possibly seeing all possible kind of price competition scenario in the U.S., so now at this juncture, still this product seems to be a kind of profitable one and possibly because of our integrated status? So can you give some sense what are the kind of profitability that one can relay this year or visualize for a late-entry product?
We cannot give details of profits at product level, but just to say that we -- obviously, it's our second Indian launch in the U.S. after Rosuvastatin. I think more than the profit, I think we're definitely making inroads into the U.S. That's more important. So helping us setup with -- for our future Indian launches. And -- but the product still gives a profit. I mean, it is a profitable product. And in fact, the API also is profitable and in India, it's profitable.
The next question is from the line of Sameer Baisiwala from Morgan Stanley.
A big congrats on Fulphila. Great job. Just on this, you mentioned 33% less price WAC. But how did we gross to net? Would it be -- would that EBIT be out of ordinary or much what we see in the industry?
Sure. Thanks for the question, Sameer. I think that level of detail about rebate, I think, is not something that we'll be able to get into here.
Okay, no problem. And you mentioned that there were quite a few DMF file in Q1. Would this be for your API business or will you be the formulator for these products? How should we think about your new DMFs?
Several APIs are coming. Not for -- not for India.
Okay, great. And any thoughts on the approval -- on the launch time lines for Glargine for Europe?
We -- by end of this year, I think Mylan has already communicated in their earnings call that they plan to launch the product by end of this calendar year.
Okay. Okay, great. And just on Aspart. I thought the -- it's in Phase III right now. I mean, at least Mylan says that. You mentioned Aspart is in Phase I.
No. Sameer, I think we just completed our Phase I study and we will be initiating the Phase III study shortly.
Okay. And how much time do you think would this study take?
We will be in discussions with the agency to see how we can work this through, but we believe that it would be subject to the scientific advise that we receive from the agency.
Sorry, can you say the last piece?
We basically are discussing with the agency to see if we could work through an abbreviated part on that study. But otherwise, we would probably see a typical study take anywhere close to 24 months.
Okay, great. Just one final question from my side, and that's on your fiscal '19 Biologics guidance of $200 million. Sir, if I remember correctly, you had earlier occasion mentioned that most of this will be most coming from emerging markets. So all these nuances that we are now seeing in the regulated markets, and I think there will be at least 2 or 3 of them, would be over and above that?
Well, all that we can say is we are maintaining our guidance of $200 million. It would definitely include some numbers coming from developed markets. So we do not expect the numbers to be too significant there. I mean, that was what we were guiding for years, that it will be initial launch quantities, and given that, the penetration in the developed markets would take time. We did not anticipate a significant contribution coming from developed markets in the $200 million.
And that view still remains. Is it?
Well, let's put it this way, Sameer. I think we are confident now of delivering on the $200 million. And any upside is obviously welcome.
The next question is from the line of Prashant Nair from Citigroup.
My first question is just to reconfirm. So that's $200 million, the sales guidance. Does it include the biosimilar you are selling in India or does that get captured completely?
So that $200 million is excluding India. That is only third-party offering. So India, revenues are captured in the Branded Formulations.
Okay. Secondly, is -- on the Glargine launch planned in Europe, would this be across markets up-front or would it be a staggard launch. And if so, then in which countries have you planned to launch in first?
This is probably best directed to Mylan, and I think they would -- they'd probably lead this piece for the collaboration. But having said that, I think, clearly, there would be an approach on how we would commercialize in the European market and we will probably reveal that to Mylan as we go along.
Yes, fair enough. And final question from me. So the 3 U.S. launch of Fulphila, trigger some amortization of the capitalized R&D?
So Prashant, we have not capitalized anything for pegfilgrastim. We have capitalized so far for trastuzumab, Glargine and bevacizumab. So all expenses for pegfilgrastim will return off in the P&L.
The next question is from the line of Charulata Gaidhani from Dalal & Broacha.
I wanted to your review on the small molecules ramp-up. Is this sustainable or is it a one-off?
So the revenues are sustainable. I mean, I think we have had a good quarter definitely, and we think that on a go-forward basis, the numbers are sustainable.
Okay. Even in the profitability?
Largely, I would say yes. Because we have had lower R&D expenses for our [ E&D ] at this quarter, and we ramp up or we have some in the expenses. On a go-forward basis, profitability for the segment will have an impact on that.
Okay. And my second question pertains to Branded Formulations. That also has seen a healthy ramp-up. Do you think that will be sustainable?
Yes. And that will be sustainable because we have seen consolidation in the top 10 products of -- and an improvement in the profit mix as well, so product mix as well. So this -- and it has come with some increase in market share in these products as well. So we see it sustaining in the months ahead.
The next question is from the line of Vrijesh Kasera from Mirae Asset.
Just a couple of questions. One on taxes, correct me if I'm wrong. There was a pre-tender litigation that was filed by Amgen. Is that litigation still on? And what is the status or are we launching this at risk?
So we cannot comment on this now.
Is the pre-tender litigation on? If we could -- I can understand that.
Yes, that's on.
That's on? Right. Secondly, on your guidance of this $200 million which you said you will be -- you are on track on achieving that. Just one question on this. Going forward -- so now we are -- if I assume that we are at around $200 million by FY '19, going forward, what is the kind of revenue or -- which we would be happy achieving, say, the next 4, 5 years from the biosimilar pipeline that we have, including the Mylan and if at all, Sandoz also, the commercialization with that Europe thing?
So yes, we have not given guidance beyond FY '19. I would encourage you to read the [indiscernible] reports who have the clear [indiscernible] on the numbers for FY '20 and '21.
The next question is from the line of Harith Mohammed from Spark Capital.
The EIR for your drug product facility in Bangalore and the clearance from the EU regulator as well for the facility. Does it cover the drug substance facility as well? Or -- and what is the status of the drug substance facility in Bangalore?
All our facilities in Bangalore have the approval from the FDA and the EU. All our Biologics, both drug substance and drug [indiscernible].
Okay. And when you do the segmental breakup of your revenues for the quarter, there is an increasingly inter-segment sales. So that's around INR 80 crores and the entire [that] you've seen in recent quarters. So what exactly is this and between what segments is this sales?
So it would be sale mainly from the shared services to Biologics. So the offset of this would be reflected in some India numbers.
Okay. And there's also, you also account that -- a note on incremental deferred revenue that you have recognized in the balance sheet.
That's right.
And what is the offsetting entry for this and can you give more color on this?
Yes, so you might be aware that IFRS has changed the revenue standard [globally]. And in line with the change, Indian -- India is also mandatorily required to adopt to the new accounting standard and the revenue recognition that India's 115. And pursuant to that, all our revenue contracts had to be reassessed or ceased. Traditionally, all our licensing income was recognized as and when we had on the revenues. However, under the new accounting standard, we are required to recognize the license income only once the product is launched. And hence, that is the de-recognition of INR 185 crores of revenue, which was put in deferred revenue line which will be recognized over a period of 10 months, we get the product approval -- the partners will get the product approvals. And that will also, by the way, change the way we recognize licensing revenues in the future, because as I mentioned until March 18, the licensing revenues were basically accrued in the books as and when we invoiced it to our customers. On a go-forward basis, whenever we own the licensing up-front, we will have to amortize that and defer it over a period of time.
Okay. And then -- so this deferred revenue is by how much? What is the incremental change?
It's INR 185 crores is the amount that had been put in the balance sheet.
Okay. And last one is on the other income, there's a higher other income for the quarter of INR 58 crores. So anything -- can you comment a bit about this?
So ForEx gain is the main reason for the increase. So out of INR 69 crores, INR 39 crores is ForEx gain.
We take the next question from the line of Surajit Pal of Prabhudas Lilladher.
Congratulations for your fast biosim launch in U.S. My question is that the result of launch of biosim vis-à-vis the market share has some mixed result. So, for example, your REMICADE is a big product. And what we found out is that despite having 3 biosim, the original market share of the biologic has not reduced much because of some strategy -- marketing strategy taken by the originator and something, the volume discount kind of scenarios. So if those scenario could come to -- even to your product, which you have launched or which you are planning to launch, what would be the marketing strategy?
Yes. Thanks for that question. Definitely, the dynamics here are complicated. I think the FDA Commissioner has spoken out about some of these dynamics recently as well, and they seem to be wanting to take action there. One thing I'd add for perspective is that while some of these ramp-ups are gradual, the sales numbers reported by Pfizer so far are pretty meaningful. They are not negligible numbers so far. I think I've seen 59 for a quarter. So they're not negligible even with these market shares. So I think there is a trade-off that's going on there and there are product-specific dynamics. In terms of the way that Mylan approaches this in how they -- what particular strategies they take, I think they will be best placed to comment on it. And certainly, it's a sensitive information at this stage.
My point was actually, is that if biosimilar guys get frustrated in terms of slow progression of market share, is there any possibility like sharp correction like what Mylan did in Copaxone. A similar kind of illusion like, say, 40%, 50% or 60% straightaway so that we could grab the greater market share, and that could be replicated by the other competitors also. So ultimately, the kind of big investment made by the biosim guys might be falling short in terms of recovery?
Sure. Obviously, we are confident in our ability to monetize our investments. And for that, this is a worthwhile market. But I think we won't comment further on the pricing dynamics.
Okay. Second question is that where does Biocon stand in terms of their filing in Copaxone? Because last time, there were some queries. We had an update. After that, what happened. Is there any progress to that?
Yes. So, we make substantial progress in terms of preparing our response to the FDA. And whilst we can't be specific in terms of the timing, we are well advanced in terms of preparing our -- gathering the necessary information for our response.
So do we expect further queries to come after that? Or you believe that this is the last?
I can't speak on behalf of the agency so...
I mean, because since you have done it, so you could go -- and others also have done it, so do you think that there is a possibility and that's my point.
Well, we have tried to prepare as comprehensive a response as we can that's why it's taken us time.
We have the next question from the line of [ CM ] Agarwal, a [indiscernible] investor.
Madam, many congratulations on being selected on the board of trustees of MIT. I have a question. I have a couple of questions. One on the annual report on Page 80 says on trastuzumab that 25% of the nearly 2 billion women diagnosed with that have Her-2 positive tumors. What percentage of these women use the Class II treatment -- or use the biosimilar treatment?
As you know, we are yet to launch our biosimilar trastuzumab in the developed markets. And our biosimilar trastuzumab is certainly expanding the patient access in the developing world market. So we are present in many, many emerging markets. And as you know in India itself, we have more than doubled the access to this drug because of cost. So we expect that this is something that will play a very strong role in providing affordable access to this life-saving drug. You're very right in asking that question as to how many of these patients actually can afford this drug. And in most of the emerging markets up until Biocon and a few other biosimilars companies were able to offer this drug, I can tell you the access was very, very limited. In India itself, we are seeing a very, very rapid expansion of this particular drug to many, many patients who need it. So we are sure that like we have done in many, many other segments, like for instance, insulin clarity, we have more than expanded this market in terms of volume almost tenfold, thanks to all the access that diabetics have got to this drug. Similarly, we think that even for these cancer drugs, which were only available to a few patients, we believe that we can actually have a multifold expansion in terms of patient access. So that is what we are committed to. As you know, that is what Biocon has been focused on. That is our purposeful mission that we are on, and that's what we will stay committed on.
Okay. And how about in the developed markets, what percentage of the women in the developed markets adopt this biosimilar treatment in Biologics?
So this is a gold standard in any case. So anyone who had HER2-plus treatment will be given this drug. So it is a standard protocol that is adopted in the developed world. But as you know, it is also something which is spiraling their health care cost. And therefore they are all very keen on getting biosimilars to bring down those cost. When it is a gold standard and when they have to give it to patients, they are looking for biosimilars to bring down these costs. And recently, the FDA Commissioner actually made a very strong case for why biosimilars should be basically adopted more expeditiously than people -- than it's being seen.
[indiscernible]
I'm sorry, Mr. Agarwal, we are having difficulty hearing you. I think, there is no response on the line. We'll take the last question from the line of Sameer Baisiwala from Morgan Stanley.
Any update on BBL, the business restructuring that was being planned?
No update, Sameer. We have applied for the government approval. We await approval. The merger process has started for BRL and BBL.
Okay. And at some point in time in the future, say what, 12 months, do you plan to list biosimilars as a separate business. And that thought process continues, is it?
Well, there's no fixed thought process on that. We said that we'll keep [on the] entities, we restructured in a way that if we will have to unlock the value and monetize any of our assets, we can do it at an opportune time. And listing is one of the options.
Okay. Okay, great. And just specifically on Copaxone, so when do you plan to re-file?
Sameer, I'm not giving a specific time line at this time, because last time we did commit to a time line, it took us longer than that. So in response to your previous question, I just said that we are trying to prepare a comprehensive response to the queries we received. And we are well advanced in terms of the compiling all the necessary data that was requested.
It will be this calendar year. Would that be fair?
I don't want to comment. But yes, we had -- we are looking at this schedule for sure.
Okay. And on Fulphila, you mentioned Coherus [indiscernible] being in November. But any thoughts on Apotex because as a parent company we haven't seen much on that. So do you expect them to launch in the foreseeable future?
So Sameer, I don't want to comment on where our competitors stand. Because you know if you look at pegfilgrastim, say, 2 years ago, we were behind in the queue and now we are actually the first to get approval and launch the product. So I think what Paul was alluding to was not the specific competitors but more to the fact that we have our eyes wide open that competition will follow.
Okay. Okay, no, that's fine. And just one final question. On Malaysian side, what could be the OpEx this year? And do you think that it will be EBITDA breakeven this year, right?
Yes, I think that's what we had guided in April that we expect an EBITDA breakeven this year. And we actually expect a breakeven this year. I don't -- the EBITDA I didn't mention, I think. It was breakeven for Malaysia. And the operating expenses was roughly $50 million.
Ladies and gentlemen, that was the last question. I now hand the conference over to Mr. Saurabh Paliwal for closing comments. Thank you, and over to you, sir.
Thank you, everyone, for joining us today. If you have any further queries or questions, please do get in touch with me. Have a good rest of the day.
Thank you very much. Ladies and gentlemen, on behalf of Biocon Limited, that concludes this conference. Thank you all for joining us, and you may now disconnect your lines.