Tushar Manudhane · Motilal Oswal Financial Services
partialReason for delay in Abraxane filing from alternate site and timeline change.
I think the fastest route that we are guiding is, the fastest route is an approval from Goa. Because, you know, because of the fact that we might have to do clinical studies if we transfer the product to another site, et cetera, the process of getting a reapproval is significant.
Tushar Manudhane · Motilal Oswal Financial Services
evasiveMarket size and competition for the peptide asset launching Q1 FY25.
Well, as of now, Tushar, we feel we are the first, we will be the first, generic, if we are given approval for it. The market size is fairly significant.
Amey Chalke · JM Financial
evasiveStrategy for Lanreotide after orphan drug exclusivity expiry in Sep 2024.
I'm not so sure that the orphan drug... I mean, I think the orphan drug expiry is with reference to certain indication. I think, so, I'm not sure that that holds up the generic for other indications that are already gen- that are, for the patents have already expired.
Damayanti Kerai · HSBC Securities and Capital Markets India Private Limited
directAdvair filing timeline and need for additional studies if transferred to CMO.
No, we don't. No, we don't think so. I don't think any additional studies are required for Advair, and your what you picked up on the timing is correct.
Neha Manpuria · Bank of America
partialRisk to Albuterol market share from Indore warning letter and recall implications.
So on Albuterol, Neha, I think, we have submitted revised data to the FDA, and of course, the FDA has to make its determination post our response of the warning letter. ... The company believes that, you know, we do not have an issue with the product.
Surya Patra · PhillipCapital
directRisk to Advair opportunity from innovator's list price cut.
I think, you know, the issue with the generic market, Surya, is that the innovators price cut, you know, matters, but in the end, it is the net price that a customer is buying at. ... our estimate of where, you know, the Advair price is somewhere right now at around the $30 per inhaler mark, as a net price.
Bino Pathiparampil · Elara Capital
directReason for decline in depreciation and amortization expense YoY.
We had some impairment last year, Bino, which has led to the higher depreciation that you see in the previous year. But, but generally, it is, it's a flat to declining trend of depreciation.
S. Mukherjee · Nomura
evasiveAre peptide assets 505(b)(2) or substitutable generics?
They're a mix, time.
Aejas Lakhani · Unifi Capital
partialCurrent US pricing environment and whether pressure is easing.
Well, there's not too much difference quarter-on-quarter. ... we typically see in quarter one of every year ... there is always more number of price challenges compared to the rest of the year. But as of now, we have not seen anything untoward.
Nitin Agarwal · DAM Capital
directSustainability of gross margin expansion and outlook for FY24.
No, I think it's a combination of pricing. ... It's likely to sustain the gross margin levels that we talked about. That's the whole idea. We are pushing for sustenance or even better gross margin.
Nithya Balasubramanian · Bernstein
directChange in US specialty strategy after Tramadol and Pulmazole setbacks.
I think it's better that, you know, that we focus our attention on generating these assets from within and be content with the fact that no one asset will be higher than INR 50 million or so, and try to build a portfolio. ... I don't think we want to take any more approval risk.
Kunal Dhamesha · Macquarie
partialSustainability of lower other expenses and cost efficiency programs.
No, we can see, like I said, this is a sustainable number, okay? And more specifically, we can unpack the numbers and discuss.