Tushar Manudhane · Motilal Oswal Financial Services
directReason for gross margin improvement: lower RM cost or product mix?
No, on gross margin it's mainly the product mix Q4 of last year, you know we had some tender products in there from CGA and other markets which were at a lower margin. So for a higher sales here we have a better mix due to which the material cost is lower.
Tushar Manudhane · Motilal Oswal Financial Services
evasiveAny update on US inspection and timeline?
No, we don't. The inspection we have answered the queries and I think we hope to and put remedial action and we hope to hear soon.
Kunal Dhamesha · Macquarie Capital
directR&D expense range for full year?
We have always given a guidance of up to close, you know max level for us would be about 6, 6.5% of sales quarter-on-quarter but you could take 5%-6% as a good range for.
Kunal Dhamesha · Macquarie Capital
partialInternal assessment on Goa plant clearance and use of consultants?
Yes. So on Goa we have given various corrective and preventive actions. We have external consultants who are working with us who are experts in their field. In Goa we've been working with those experts for two years and in Indore for over a year and they continue to be with. They continue to be assisting us in our response and remedial measures. I think the FDA will come to its conclusion by end September. That's the time that we hope to hear from them further.
Kunal Dhamesha · Macquarie Capital
partialUpdate on US peptide approvals and Advair filing?
Yes, the moment we receive approval we should be launching these peptides. But I believe that the real launches will start only starting quarter three, quarter four of this year, not before that.
Damayanti Kerai · HSBC
directClarification on Advair timeline: launch or filing?
No ANDA filing will. So we will take batches now. The filing with the six-month stability will happen probably closer to December or January.
Damayanti Kerai · HSBC
directDrivers of $25 million QoQ US revenue increase?
The two, two big products made the difference. Lanreotide, the ANDA launch, the generic ANDA launch as well as the gain in albuterol market share, those were the two big contributors here. And then there was as Ashish mentioned a marginal increase in Lenalidomide.
Damayanti Kerai · HSBC
directPlan to revise EBITDA margin guidance given strong Q1?
I don't think we're doing anything on the EBITDA margin guidance, but I'll let Ashish clarify on the gross margin.
Surya Narayan Patra · PhillipCapital
partialImpact of generic Lanreotide launch on branded version?
Yeah, I think so. Look, the ANDA product was launched. See, overall, if you look at it, we are about 20%-22% share before the ANDA launch of the total market. The B2 has stabilized at this share, and now with the ANDA launch, I think the ANDA launch should hopefully add to this overall share.
Neha Manpuria · Bank of America
directRisk of generic Lanreotide cannibalizing 505(b)(2) share?
In a market where NEHA supply is abundant, that could happen. But in a market where supply ramp up is very slow, it's unlikely that that will happen.
Neha Manpuria · Bank of America
partialCapital allocation priorities with $1 billion cash?
Sure. So we are all, you know, continuously looking at strategic opportunities, both India as well as outside and mainly India. So I think that scanning continues and you know, in branded generics space in India we are very keen to grow in therapies where we don't have leadership.
Sumit Gupta · Centrum
directCapEx plan over next 2-3 years?
See, our run rate has been about, you know, INR 1,000 crore to INR 1,200 crore. So I think that would be, that will go up slightly because we're looking at, see, we've had some CapEx in the U.S. Now for the de-risking, then we're looking at some more strategic CapEx in India mainly on the respiratory side. So all this will actually take it to possibly about INR 1,500 crore to INR 1,800 crore somewhere on. That kind of range.