From Natco Pharma Limited Q3 FY17 Earnings Conference Call (February 15, 2017)
Karthik Mehta: Just want to understand from you on the recent comments from two of your Indian competitors who seem to be facing some delays on Copaxone file, which they have submitted, I am not asking you timeline for your approval, do you believe after your approval if it comes in FY2018 or if it comes in FY2017, so a reasonable amount of time will there be only two to three generics in that and so if it does not add to the risk launch, do you believe the smaller players may actually to launch the product in particular for 40mg?
Rajeev Nannapaneni (Vice Chairman and CEO Natco): If you have a question on 20 and 40, so let me address 20 first. As you know our ANDA has been pending with FDA for many years and it is a very tough product to do I think as everybody is aware, there is only one approval as you know and we did a lot of work and it is not easy for everybody to replicate that work, so in our mind we think there will be limited competition; however, I am not ready to the quality of the work that the other guys have done and what the nature of queries they have got so we do not know where, how well they are doing, so that is the question I cannot answer, but I would still believe that there will be limited competitions and the other question you had was on the 40, what was the question about 40 again Karthik?
Karthik Mehta: So if the patent is still not invalid and then technically though you and Mylan may have different views it can be an at-risk launch, do you believe smaller players may not to launch 40 mg.
Rajeev Nannapaneni: I do not know about other people what they think they are going to do and regarding the 40 mg at-risk launch is a call that Mylan have to make Karthik, personally we cannot make that call, I think as Mylan said in the past when the market formation happens, when we get the approval in place, I think then Mylan will make whatever decision they deem fit at that time. As of now it is too premature to talk about that, but I think right now our focus is on getting the approval and I think let us focus on that and we think 20 is the earliest one that we expect, so we are hopeful we should get it soon and we have answered all the queries that are pending on the 20, so we are hopeful that once we get 20 then I think we can talk about the other one.
Sameer Baisiwala: Thanks. Good morning. Quick question on Copaxone suppose as and when you do get approval for 20 mg what implication would that have on your 40 mg file?
Rajeev Nannapaneni: That will be a good indication Sameer because if you look at the queries logically the queries are revolved around the characterization of the API and if you have 20 approval on hand it gives me tremendous amount of confidence that 40 will come obviously subjected to the court cases and all, but actually from the regulatory side I will be extremely comfortable that we can get the 40 range.
Sameer Baisiwala: Wonderful and what could be the potential time gap between the two, is it going to be a short three, four months or is it going to be a longer than that?
Rajeev Nannapaneni: At this time I cannot predict Sameer, again I think as of now I think for what my understanding in discussion with Mylan is 20 is first in queue, so I think let me get 20 and then I will speak about 40.
Sameer Baisiwala: Fair enough, what I am trying to say is 40 may also under active review?
Rajeev Nannapaneni: Absolutely, it is under active review, yes, correct.
Afzal Mohammed: Thank you again for taking my question. Are there any pending queries remaining from FDA for COP 20?
Rajeev Nannapaneni: Copaxone 20 no, we have answered everything.
Rakesh Naidu: Hi. Thanks for the opportunity. Rajeev did I hear correctly when you said that USFDA’s queries on Copaxone 20 mg were primarily related to characterization data package?
Rajeev Nannapaneni: Say it again, is the question related with characterization is that what you said?
Rakesh Naidu: Yes.
Rajeev Nannapaneni: Yes, they were I think, yes that is correct.
Rakesh Naidu: So in terms of your expectation on this product and the conversation that you have been having with the regulators, what is your view in terms of the approval timelines?
Rajeev Nannapaneni: I think we should – I think my sense is the 20 we should get the approvals.
Rakesh Naidu: And the data package, which was submitted to them was not part of the initial submission?
Rajeev Nannapaneni: Rakesh I will tell you about Copaxone basically we file with a certain data package and over the years we have got a lot of queries and based on the queries we did a lot of data and we generated a lot of data, a lot of changes we did, so this process has been fairly dynamic, we worked with regulator and we have done lot of work, so what we started off and what we ended up today is completely different, but that is the nature of doing complex generics that you work with regulator and evolve with the questions and that is how it works and what we start off the question is what you start off with and what you end up with is completely different.
Rakesh Naidu: So does it imply that when you say the course correction had to be changed, your approach towards data generation had to be corrected as the conversation with..
Rajeev Nannapaneni: I think based on the questions that they ask you do, yes absolutely, do a lot of work.
Rakesh Naidu: Right, because it has been a pretty inordinate delay like Sandoz is already there, so..
Rajeev Nannapaneni: It is delayed, but if you want the big jackpot these are the ones, we spoke few minutes ago and we spoke about customer consolidation, do I see a value if there are four or five filers on day one, unfortunately there is no value in this, there are multiple guys in the business. If you are doing the harder ones they make take longer to happen, they might be more complexed, there is more uncertainty, you cannot predict timelines on launches, but that is where the real value is Rakesh either you do that or you do a patent challenge that nobody wants to do, you do uptake a position that nobody wants to take and suddenly you get a decision, which is in your favour and then suddenly you were in a very good situation, but unless you do that leap up face and invest and take that chance, it will be very hard to generate value, at least the way I see it.
Rakesh Naidu: Would you want to commit any timeline in terms of or it is difficult take a guess?
Rajeev Nannapaneni: On the 20 approval you are saying or?
Rakesh Naidu: Yes.
Rajeev Nannapaneni: I think it should happen, I have been saying it for so many years now it becomes so difficult to again come back and say the same thing. We are still confident that will happen, I think we are still confident that should happen shortly, I think I am very positive, I am more positive than before, but again I have been saying it for a year – I think everybody gets a little bold with what I said, but that is all it works but obviously you put the caveat on the table, yes we are positive, but at the same time it is a complex generic and you do not know how long it actually takes and when you do a chemistry product that is more or less you can predict whether you have it right or you do not have it right and how long will it take you to fix, but with something like this, it is harder, but that is where the real value is Rakesh I mean that is the challenges of business unless you are willing to do that then you cannot go up to the next value changes.
Rakesh Naidu: Right, one more followup, in terms of your commercialization strategy approach for this particular product, how do you think you can, you and Mylan can differentiate vis-à-vis what Sandoz has been doing right now?
Rajeev Nannapaneni: As of now I have not discussed about the strategy with them, as of now I do not have any views, I think once you get closer to the approval, we have the approval in place and when we have a call I will probably have more clarity on what the strategy and then I can lay it out, as of now I do not have an answer to that question.
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