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(3) Press Release, Dr. Reddys announces the launch of Gemcitabine for Injection, July 27, 2011 |
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Saion Mukherjee | I have a question on the domestic market because towards the mid of the last quarter, we were expecting that
the growth will revive after a muted Q4. But that hasnt happened. So can you throw some more light, as to
why the growth has been sluggish in India? What steps are we taking? And how do you see growth reviving from
a 1 to 2 year perspective? |
|
Satish Reddy | Okay the growth has been disappointing, yes. We did indicate that things should improve from this financial
year onwards, but quarter 1 results have not certainly reflected that, so we do express a sense of
disappointment over that. So looking to the some of the reasons why and what do we expect going forward, if
you look at this there is some initiatives we have undertaken about, say, 2 years back. One was field force
expansion. We also wanted to redeploy some of the field force. But I think the deployment as well as the
expansion have not yielded the sales increases that we expected it would, right, so thats one issue which
needs to be still tackled. And were still working on it, right, so thats one. As far as the other
initiative goes, the expansion to rural markets, while it has started off well, there was a good scale-up in
the previous year. Theres been some issues with that in terms of field force attrition and things like
that, which was somewhat beyond our control, right, but thats something we also had to anticipate. So I
mean, these are two primary reasons we have seen, the first quarter was also hit with somewhat a lower
growth in some of the top brands, so thats another issue. So these are broadly what I see as the issues for
the first quarter compared to, say, what we anticipated in the previous quarter. Now while its work-in
progress in terms of trying to sort out the execution issues, I would expect that things to start looking up
in the second half of the year, right, so this will be based on some of the interventions, which we have
started plugging in early enough this quarter. But again, I would still like to see the performance of the
second quarter. Once that improves, I would be able to comment more on that. I will be able to say with much
more confidence on what happens in the second half, which I am sure, will definitely start recovering. |
|
Saion Mukherjee | And just one more question, have you seen an authorized generic in fonda yet? |
|
GV Prasad | Not yet, but we heard of a possible authorized generic. |
|
Manoj Garg | Have you seen any pricing pressure in the domestic market? Because for one of your products like
rabeprazole, Pfizer has come out with almost little like 50% of your pricing. So do you see that MNCs coming
out with a very aggressive pricing and its affecting the overall pricing strategy in the Indian market? |
|
Satish Reddy | Its not just MNCs, I think, even among the Indian companies and overall if you see the industry itself
there is intense pricing pressures happening to various products. So obviously, it does affect the market
share, and thats something we all seen, yes. |
|
Manoj Garg | And have you also taken some like price corrections in rabeprazole? |
8
Satish Reddy | It is one of the leading products for us. We have not done anything. |
|
Manoj Garg | And what could be the adverse impact of nimesulide because there was some confusion in the market and, well,
it might have impacted growth in the market. |
|
Satish Reddy | Nimesulide, I think from the time EMEA had put in some restrictions in the past, especially the issues on
the pediatric suspension, which we had withdrawn quite some time back. I think the recent EMEA report also
has clarified in terms of the benefits of nimesulide, except for chronic usage of that, which is something
which we had already implemented quite some time in the past. But I think the whole activity, especially by
competition, by also putting in false propaganda in one case, actually we had successfully gone to court
to restrain them. So this is something which has also seen de-growth in this molecule compared to the past.
Thats something we have definitely seen in this molecule. |
|
Perin Ali | What could be the depreciation and amortization impact because of the Bristol facility in the U.S. for this
quarter? |
|
Umang Vohra | Itd be about $1 million to $1.5 million. |
|
Ranjit Kapadia | My question relates to the domestic market. If you can throw some light on the sales force? And how much of
sales force was added in the last year? And any change in the guidance for FY 12? |
|
Satish Reddy | First of all we have not guided for FY 12, right? |
|
Ranjit Kapadia | Sorry FY13 of $2.7 billion guidance, whether it has changed or that you are revising... |
|
Satish Reddy | That still remains. Theres no change because of what you have seen, just because of the Indian market
growth in the first quarter. Thats no indication of any revision or any change. We still stick to the
guidance, what we have indicated. In terms of the field force that you are asking, I think, last year, we
added quite significantly to the field force, and it was about 500. |
|
Ranjit Kapadia | And what is the current strength now? |
|
Satish Reddy | The total will be about 3,800. |
|
Ranjit Kapadia | When do you feel that the full potential of this 500 people will be available to us? |
|
Satish Reddy | I think its difficult to comment, saying that just because we added field force, overnight sales are going
to increase. Thats not what I was intending to say. So it is about field force which has been added in
different marketing divisions and also the field force strategies that we employ and the execution that
happens after that. So its a combination of various things, which I said that, on execution, we have not
performed up to expectations. |
|
Ranjit Kapadia | And what is the attrition rate in the field force currently? |
9
Kedar Upadhye | Across the division it varies but overall, its about 25%. |
|
Hitesh Mahida | First thing is what will be sales contribution and how much is the cost of the new GSK facility, penicillin
facility? |
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Umang Vohra | The sales are about $4 million, and the cost of the facility, because we havent yet scaled up, is about $5
million. |
|
Hitesh Mahida | And how much sort of peak sales, are you expecting from this? |
|
Umang Vohra | This will peak in quarter 3, and I think it could go at an average run rate of almost about $8 million to
$10 million. But this is a seasonal product, so you will begin to see the variations between quarter 1 and
quarter 3 at a full year average, and a good rate would be about $5-million-odd per month. |
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Hitesh Mahida | Whats your view on the German pharma market? Even after we have started AOK supply do you expect sales
growth this year? |
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Satish Reddy | Sales will definitely not grow because we have already indicated in the last year itself that the price
declines will continue for this year. So what youre seeing in the first quarter is generally the trend even
for the rest of the year because the view on the market is that while AOK tender have good products with
increasing volumes, as an outcome of that, because of the pricing pressures, thats why you see the decline. |
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Hitesh Mahida | And what would be your market share in lansoprazole, tacrolimus, fexofenadine and omeprazole? |
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Kedar Upadhye | We will share these numbers offline with you. |
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Sushant Dalmia | Just one question in terms of the housekeeping, I suppose the $3 million of the VRS has been in the SG&A
costs. And interest on bonus-debentures is clubbed in the financial expenses. That would be right? |
|
Umang Vohra | I will just clarify: The VRS, it is split 70% in the manufacturing cost and 30% in the SG&A. And the
interest is in the interest line, the bonus debenture interest is in finance income. |
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Bino Pathiparampil | When you said that fonda will be launched in a phased manner over the quarters, can we go a little deeper
into that? Why is it phased? And what is the time period in which you expect to achieve the best market
share? |
|
G. V. Prasad | So part of the reason, this is going to be a slow phasing is because of the
complexity of manufacturing of this product. So it involves nearly 60 steps of manufacturing,
and hence, while we launch the product, I think well be able to fully exploit the market
share of the product in about 3 months from now. |
|
Bino Pathiparampil | Just today, there was a FDA release that you got an approval for palonosetron
hydrochloride. |
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G. V. Prasad | Its a tentative approval. |
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Bino Pathiparampil | Allegra D 24. Did I hear that you said you already got the approval? |
|
Umang Vohra | Yes, we have received the approval. We are hoping to launch. |
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Bino Pathiparampil | In the calculation of EBITDA, you have added back interest of about Rs. 22 crores in your press release,
whereas the interest in your P&L is only about Rs. 4 crores or Rs. 5 crores. So what is the disconnect
there? |
|
Kedar Upadhye | So, Bino, the interest in the P&L is actually the net finance expense, so that includes forex gain also. You
can see the last page of the press release; it will give you all the components adding up to the EBITDA and
finance expenses. |
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Umang Vohra | Bino, we had 16 crores of forex gain this quarter. |
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Bino Pathiparampil | So EBITDA number you have given out, includes that forex? |
|
Umang Vohra | Thats right. |
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Sonal Gupta | Just wanted to get a sense on; we are seeing a weak trend in terms of growth in our other CIS markets, other
than Russia and also in the ROW markets. I think we are seeing it sort of weaker even over the last couple
of quarters so, I just wanted to get a sense on whats happening there? |
|
Satish Reddy | Couple of markets had devaluation right. So Venezuela was one and also Belarus. We are talking about steep
devaluation of the currency so, thats one impact of what has happened and thats the issue. |
|
Umang Vohra | Other than that I dont think there is too much that we are concerned about right now. |
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Girish Bakhru | Just on fondaparinux, I wanted to understand, basically if there are different channels where fonda is
probably more taken like it is probably a hospital based channel which takes the product more, just a little
more colour on that. |
|
Umang Vohra | Fonda is split about 60% in hospitals and 40% in retail and wholesale. |
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Girish Bakhru | The US launch is pretty much a priority right now but any update on the EU filing, where there is a stand
right now. |
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Umang Vohra | We are not providing an update on that as yet. |
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Kedar Upadhye | Well the data exclusivity runs till next year Girish. |
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Girish Bakhru | I understand data exclusivity is still 2012 but filing would of course be in preparation right. |
|
Umang Vohra | Yeah so we are not commenting on that right now but it is our plan to try to monetize fondaparinux as much
as we can across the world. |
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Girish Bakhru | Just wanted some more color on the US, it is of course pretty strong and the OTC launch has been there but
how have been the launches in Lotrel higher strength and levocetirizine in some of the launches which were
pretty recent, how has been the market share there and what is the colour on where the base sales might go
to by the end of the year. I mean excluding some of the exclusive launches which may be coming in the latter
half of the year. |
|
G. V. Prasad | So these products are highly competitive because of a very large number of players
launching the product so, I dont think they form a significant portion of our sales. |
|
Abhay Shanbhag | Taking this question forward on fondaparinux, you said 60% is hospitals and 40% is wholesale retail. Right now
in the press release, you were indicating that we would be targeting wholesale retail. Is that what you will
start off right now, targeting 40% of the market? |
|
Umang Vohra | Yeah thats right. |
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Abhay Shanbhag | And say in three months time you would then target a balance to the market. In terms of hospital distribution
because you dont really have too many injectables in place so, what sort of market tie up you would have to
take this product forward? |
|
Umang Vohra | So, this one is a little different from the rest of the products that sell in the hospitals so it doesnt
require that kind of a special GPO type of an organization. |
|
Abhay Shanbhag | And what sort of market share can we presume by March-April of next year can we assume it at 30-35% market share
build up over April, May, June next year or will it take longer to reach market shares like that? |
|
Umang Vohra | Abhay we are not commenting on that as yet. |
|
Abhay Shanbhag | The last one was on Russia. You indicated 30% is OTC now, how much is hospitals as a percentage of your Russia
revenues? |
|
Umang Vohra | Less than 5% would be hospitals and we have plans to see what products we could pick and choose, to increase
that portfolio and prepare it for the biosimilars and the other oncology products that we will be launching in
the near future. |
|
Abhay Shanbhag | Any outlook on the Russian pricing, is there any transition, is there any expectation of any price change or
structural change from the Russian market? |
|
Umang Vohra | We havent heard anything in this quarter which is significantly different from the previous quarters. However,
we will continue to maintain the stand that we dont see anything drastic happening in Russia, except that the
long term trend of that market would be to probably correct a bit in terms of pricing. |
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Ravi Agrawal | Just a question on the GSK penicillin facility. If I got Umang right, he was mentioning 5 million on a monthly
basis as a regular trend? |
|
Umang Vohra | There are two things that are indicated, 5 million was the cost that we had in this quarter and the average
sales that I mentioned on the subsequent question were 5 million per month. |
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Ravi Agrawal | So, average sales on a steady state base can be around 5 million. |
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Umang Vohra | Can be 5 million but it would spread between 2 million and 8 million depending on the season but the cost is 5
million roughly per quarter so, what we have shown in this quarter is 5 million cost. |
|
Ravi Agrawal | Just going on in the question on the penicillin facility. I do believe one of the reasons for acquiring the
facility was also to take part in the tender businesses which come up in the US. Any thoughts you want to share,
about whether it could actually see some upside in terms of revenues from tenders in that facility for this
year. |
|
G. V. Prasad | I think we should go over to 60 million on an annualized basis. Let us see what
upside comes. |
|
Ravi Agrawal | The second question was on the ROW markets and the growth of around 6%. When do we
actually see the benefits from the GSK alliance from the emerging markets, actually begin to
flow-in in terms of some of the numbers for ROW markets so, we had some sales coming from some
markets last year. |
|
G. V. Prasad | Meaningful numbers post 2014. |
|
Anubhav Agarwal | I just want to understand the SG&A part slightly better. When you say for the Bristol facility the cost is $5
million. Is that all the fixed cost which is included in SG&A? |
|
Umang Vohra | No SG&A has about $2 million. |
|
Anubhav Agarwal | Okay, if we just look at SG&A sequentially excluding the amortization part, it has just increased by roughly
around $10 million. So $2 million is for the Bristol facility. So, when you ramp up, lets say for the full
year sales of $60 million from the Bristol facility, what could the SG&A component look like? |
|
Umang Vohra | I dont think the SG&A will change too much. |
|
Anubhav Agarwal | Its fully factored in there. Should we consider this as true base to go forward for the SG&A part, or are
there the some more costs other than factoring the normal increase in personnel cost every year. |
|
Kedar Upadhye | This could be considered as base except, where except the quarters where we might have to spend on OTC in
Russia and other onetime expenses. |
|
Anubhav Agarwal | So, that incremental spend on the OTC in Russia would be for the future products but for the current products
that you have in the market, the expense is very much there in the numbers would that be fair. |
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Kedar Upadhye | Even for the existing products, the timing of various campaigns might be spread across various quarters. |
|
Anubhav Agarwal | Just to understand this slightly better, is the first quarter on a higher side or a much lower side in terms
of OTC expense and for example if I look at SG&A number, it is 631 crores for this quarter excluding SG&A and
the impact on VRS, what is an OTC expenditure part of this. |
|
Umang Vohra | We are not guiding to that level of granularity but if you were to look at maybe a quarter 3 or quarter 4 and
our quarter 1, quarter 3 of last year, quarter 4 of last year and quarter 1 of this year, you will come to a
rough average around the level that you are talking about. |
|
Anubhav Agarwal | The next question was just on the India business. You did mention about several products but on therapy basis
can you just guide, which therapies are you facing the maximum pricing pressure? Is it like more within the
acute side, is it like anti-infective or GI, can you help with that kind of slightly broader outlook? |
|
Umang Vohra | It is more on the acute and the cardio side. |
|
Anubhav Agarwal | Okay and not much of pressure on the anti-infective and GI so those.... |
|
Umang Vohra | So anti-infective doesnt really affect us too much because we dont have too big a portfolio on that. |
|
Anubhav Agarwal | Okay and just one more question on the gross margin on the PSAI segment, like sequentially they were down
something from 27% to 24% level. Was it only the import alert because import alert essentially for you guys,
came in at the fag end of the quarter right? What was the essential reason, was it just the problem on the
service business? |
|
Umang Vohra | Yeah it was the service business problem and it was slightly higher input costs, which after the crude is
corrected a bit, have began to even out. |
|
Anubhav Agarwal | Just a last question here on the tax rate, the true tax rates for this quarter is something like 17.5%? |
|
Umang Vohra | Well thats right 16% is a true tax rate for this quarter. |
|
Anubhav Agarwal | For the total business you have guided to 21% but for the base business its 16%, is it more representative
number or something higher is a more representative number? |
|
Umang Vohra | 16% is the more representative for base case. |
|
Sameer Baisiwala | Can you update us on the two industrial accidents that had happened in December and then one after that in
which we had two deaths each? Specifically, have regulators visited your Bolarum facility after that and could
this culminate in to something more serious like a warning letter or import alert or something like that? |
14
G. V. Prasad | The accidents took place in our API facilities. One was a fire accident and another
one was nitrogen caused asphyxiation in a confined space. In both these cases, investigations
are going on. In one case, we have replied to a showcase notice, in another one the
proceedings are going on. We expect some investigation and some regulatory action on this but
nothing which should stop manufacturing or rather financial impact as such but there could be
some action by the department. |
|
Sameer Baisiwala | Which department is it, a local authority or is it? |
|
G.V. Prasad | Local AP state authority. Director of Factories, which comes under the Ministry of
Labour. |
|
Sameer Baisiwala | Okay but ever since then did you have regulators from foreign countries visiting
in? |
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G. V. Prasad | No this has no implication on foreign regulators. They have no jurisdiction on
this. |
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Sameer Baisiwala | Would FDA not at some point in time come over here and do inspection? |
|
G. V. Prasad | There is nothing to do with the quality of the product because there was an
industrial accident involving people and equipments, so there was no product involvement. |
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Sameer Baisiwala | Just update us on the Shreveport facility ramp up that you have mentioned on your
previous call has that started or when should we expect that? |
|
G. V. Prasad | Part of the shift of manufacturing from here to there has slowed down because we
have got additional business at Shreveport directly from our customers for some of the
products that existed, when we purchased the facility and so hence you know the shift from
India is slowing down. So the facility is fully utilized now and we are actually expanding the
facility. |
|
Umang Vohra | Sameer, quarter 2 we should see some revenues on account of that. |
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Sameer Baisiwala: | And I assume that you had a good fexo-plain OTC launch, has this been good enough to make up for what you
have lost in the RX setting on a value basis? |
|
Kedar Upadhye | Yeah it would be Sameer, on a full year basis it could be. |
|
Sameer Baisiwala | Okay and just one final question on fonda pricing, is it something that is more or less in line with what
happens with a one player market dynamics, plus authorized generic which is 20%, 30% erosion or is it
something different than that. |
|
G. V. Prasad | We hope it will be like that. |
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Nitin Agarwal | One is on the biosimilars front, you know even in the annual report we stressed
quite a bit upon our capabilities in biosimilars and that being our medium term growth driver.
So beyond the launches that you have done in India, how do you see the biosimilar road map
really playing out for us over the next 2-3 years? |
15
G. V. Prasad | We have started registering the products in markets, which will allow us to
register products on basis of the clinical trials we have done in India and some marginal
additional trials. So that revenue, I think will become significant by 2014 or so. But the
real value unlocking will happen when the products are launched in the US and European
markets. So for these, we have to do much bigger trials and our plan is to partner with
somebody who has the expertise to do large scale clinical trials as well as detail and market
the product in these geographies. So, in the meanwhile we are progressing the product and we
had EMEA meetings. We have requested a meeting with the US FDA and the process of registering
and doing the clinical trial will continue, we will not wait for a partner. But we believe
that the full potential of the first few biosimilars from Dr. Reddys portfolio will be
unlocked only with a strong partner. So but you know these patents have to expire, we have to
do the trials, we have to file. So they are a little bit away 2015-16 onwards. |
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Nitin Agarwal | How material could the Rest of World opportunity is for you for these products? |
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G. V. Prasad | I hate to put numbers but they will be significant. |
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Nitin Agarwal | Okay and secondly in terms of India, how many new products in this biosimilars front
you are looking to launch, we have already launched four, so how do you see that playing out
in India per se. |
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G. V. Prasad | I think we should launch another product by next 12 months and repeat that every 12 months. |
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Nitin Agarwal | Okay and on the US business side we have got about $129 million sales for the
current quarter. So barring the launches that will come incrementally for the existing bunch
of products, is it like a base that is pretty much safe to assume that? |
|
G. V. Prasad | Yeah pretty much safe to assume that is the base. |
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Nitin Agarwal | And in terms of the pace of the market share addition, which is there on lanso and
tacro and is it still significant upside left in terms of more market share gains or we are
kind of maxing out on market share gains that you can have on these products. |
|
G. V. Prasad | Some products there is headroom left but not all. |
|
Nitin Agarwal | Lastly how many products are we looking to launch during the year going forward. |
|
G. V. Prasad | I think something like 10-12 products. |
|
Umang Vohra | Yeah about 10 in the US. |
16
Nitin Agarwal | And barring the 2 or 3 that we have talked about in terms of
niche opportunity, all of them are going to be plain vanilla
or they are going to be some interesting launches even in
the ones that we have not really specifically mentioned. |
|
G. V. Prasad | I wish I could predict that with great accuracy because sometimes what we think is
plain vanilla turns out to be big winner and sometimes what we thing is big one, turns out to
be a very competitive product. But I do think there is a significant possibility there. |
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Saion Mukherjee | Just one question on the Mexico facility and the impact of import alert, given that now we are allowed to
market naproxen. What is overall yearly impact that you see because of the import alert? |
|
Satish Reddy | See roughly from the Mexico facility, we had a sale of on an average of about $60 million a year. So you are
looking at naproxen, which is half that and you know there are some other products also, that is the extent of
the hit, if you should take it based on what you have just said. |
|
Saion Mukherjee | Around $30 millions. |
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Satish Reddy | 30 is full year by the way. |
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Saion Mukherjee | On the R&D cost, Prasad you mentioned about, you know increased or a step-up in R&D spent because of the
complex filing of biosimilars and proprietary products. What is the level of R&D spend that we could expect.
What is the level of step up that you are kind of looking at in absolute level? |
|
Satish Reddy | Yeah I think in the past we used to be around 6% of the sale. Even in the first quarter, we are roughly around
that. I think what we have generally guided is that we should be about 7-7.5% of sales. That is what we expect
it to be, which is quite significant as a step up because by looking at sales increasing and then we are saying
of a percentage and half increase on top of that. |
|
Saion Mukherjee | So basically you know if you are talking about 2.7 billion in FY13, so we could expect around 7% of that to be
the R&D spends? |
|
Umang Vohra | That is right 7-7.5% Saion, on some of the biosimilars trials as well. |
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Surjeet Pal | As you say, you will be targeting 40% of the fonda market in US, which is mainly retail and wholesale and 60%
hospital and since it is an injectable product. So I was thinking, that since there is talk about AG and if AG
is given to any established hospital generic guys like without mentioning any name, like those who are already
available in US. Do you think that will have a dent on the potential revenue for your product? |
|
Umang Vohra | We dont think so for several reasons because like I mentioned before this is not a complete GPO type of a
product and we are vertical on this product and we have the best cost position on it. |
17
Surjeet Pal | So you believe any established guy in the top three hospital distributors in US, if they get the AG it will not
impact your potential as you know even in hospitals segment. |
|
Umang Vohra | See any AG will impact our potential revenue but we are quite confident of retaining relatively large market
share over time. |
|
Surjeet Pal | Another point is that, as you were saying is that you are also putting money on proprietary technology through
R&D expenditure and going by the kind of niche product as fonda has. Are you planning or do you have in your
pipeline any similar carbohydrates synthesis based products which are pretty complex in nature and your team
has done a fantastic job by scaling up of a successful doing. So do you have any product in pipeline or any
expectation in say next two years time? |
|
Umang Vohra | We have products in our pipeline which are very complicated and require characterization like fonda required
and we have got a nice emerging pipeline of that. |
|
Prakash Agarwal | Just one question on the gross margin side if you look at Q1 2012 and Q1 2011, not much of an improvement in
spite of few large high value-high margin products being there for the last two-three quarters. So any
particular reason or is it because of the lower domestic business growth which is again a high margin product
for you. |
|
Kedar Upadhye | You know it is function of variety of factors. You know partly the cost of the new facility in US; you know
that portion has come in the cost of goods sold, that is one factor. Secondly what you rightly mentioned is
that, the proportion of India is a bit lower this quarter. So it is result of a number of several factors like
this. |
|
Prakash Agarwal | And just going to Russia, I mean we all are aware of this Pharma 20/20 which is spread across 3-4 step
functions, specially talking about 2013-2017 where it aims to replace 50% of the imported generic drugs with
locally produced products. Is there a strategy which we have in terms of buying out a local body or setting up
our own facility because what I understand is that, we are currently a marketing company in Russia? |
|
Satish Reddy | I mean we still have to wait to see how it actually plays out, it is not as simple as just stating that this is
what the government wants to do and then it will just happen overnight . So there will be a lead time by the
time it will happen and then I think each company will formulate its own strategy. So currently, we dont have
any immediate plans to acquire anything local or any such thing. There are several options to it, which we are
still evaluating. As things keep progressing, we will take a stance on that but there is no tearing hurry to
get into any one of this concern. |
|
Prakash Agarwal | Okay and on the tax rate, I think I missed something what Umang said was 15% on an annualized basis or 21%
given the olanzapine being on the second half. |
|
Umang Vohra | So lets say without olanzapine we are at 16% or with olanzapine we are at 21%. |
18
Prakash Agarwal | On a full year basis? |
|
Umang Vohra | That is right and that is why this quarter, what we normalized to 16. |
|
Prakash Agarwal | Okay so going forward, we would see a much higher tax rate than the annualized 16%. |
|
Umang Vohra | You would see higher than the 16 in the quarters where we have the exclusivity and around 16 in the quarters
that we dont have. |
|
Prakash Agarwal | Perfect and any more colour you could give on Lipitor. I mean last we heard that you had a 30-month stay around
May or something can you throw some more light there? |
|
Umang Vohra | We cannot comment on that right now. We choose not to comment on that please. |
|
Prakash Agarwal | But we are definitely there in that product, that is what I wanted to understand. |
|
Umang Vohra | Yes, we are on that product but I cant comment on the exact dynamics of it right now. |
|
Nimish Mehta | I actually missed the number that you mentioned from the penicillin facility. How much sales have you booked
for this quarter if you can just repeat that. |
|
Kedar Upadhye | We have booked $4 million. |
|
Ashwin Agarwal | Indian companies were very high in quality but recently we have seen many Indian companies in general getting
FDA warnings, so have FDA regulations become more stringent? |
|
Satish Reddy | I would just say Ashwin that FDA scrutiny generally has increased for the past couple of years which was a
stated intent. I dont think it targeted just at Indian companies, generally for all the companies it has
happened. So we have seen multinational companies, we have seen large generic international companies, a lot of
Indian companies with those issues. |
|
Ashwin Agarwal | Right one more observation I have seen, the time gap between a warning letter and an import alert has reduced
significantly. Any reason that they dont want companies to fill the pipeline in the US which you can market or
what has been the reason? |
|
Satish Reddy | I mean I dont know particularly why that is; it is something that the regulator should answer. |
|
Chirag Talati | If you look at your annual report for FY11, then the DEPB credits and other related credits have gone up
materially as a percentage of sales, almost doubled or more than doubled. How should we look at it going
forward, if that goes down could we see it hurting your margins for say FY12 and FY13, how should we look at
it? |
|
Umang Vohra | It should not impact the margins materially because I think the government will also announce a separate scheme
or extend the DBK scheme with possibly a higher rate. So we dont expect too much of an impact on margins.
However, the numbers that you are seeing in our annual report also is an outcome of what we sold in terms of
Fexo-Pseudo into the market. So for the jump that you are seeing includes that. |
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Chirag Talati | Okay fine and one question, could you update us on how the business has evolved for Promius Pharma as a whole
and how do you see that going forward and some update on your terbinafine product for which you had phase three
already enrolled? |
|
Umang Vohra | Though the terbinafine trials are ongoing, we have not got an early read kind of a methodology for that trial
and we hope to receive data from that over the next one year. On proprietary products our business is
approximately $20 million in size and we are hoping to add more from our pipeline to take that higher as we go
along. |
|
Chirag Talati | I mean you acquired Cloderm, so how should we see the potential of that product in terms of peak sales going
forward. |
|
Umang Vohra | We arent guiding to that as yet Chirag, we are not guiding by each product sale but the rationale for that
acquisition was to enable us to be a little bit more critically sized on the Promius space. |
|
Chirag Talati | Yeah okay thanks that answer my question. Thank you. |
|
Vidhya Bharati | Yeah just on the margins, as you said from June onwards you have actually started supplying for the AOK
tenders. How much was an erosion you are seeing going forward, or are the margins made this time sustainable
what is your take on it sir? |
|
Kedar Upadhye | Vidhya, we dont want to comment on the specific margins related to the AOK tender but what we said is, for the
overall Germany business that shows from the year-on-year price compression, we could see some margins dip.
Although at an overall consolidated financials, we dont see there would be any noticeable impact. |
|
Vidhya Bharati | On the annual average figure, you said around 5 million for the GSK penicillin facility, does that include the
one you told you will launch now from quarter 3, and does 60 million odd annual figure includes that? |
|
Kedar Upadhye | Yeah so it might be phased in the respective quarter in which the launch happens. So what we say is that the
monthly range could vary and on an average basis it could settle down to about $5 million or so, again this is
a forward looking statement. |
|
Vidhya Bharati | Okay on the R&D focus, if you could just re-emphasize on your focused therapy areas you were looking at going
forward because you said your filings are going to come down and it could be more on a complex product based
filings, so if you could re-emphasize where you are focused right now? |
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Kedar Upadhye | It will be from the US side, it will more dictated by the patent expiries and as of now we dont have any
therapy bias in the portfolio. But from a complexity perspective you know we would like to increase the
proportion of characterization led new products because that is where our strength lies. |
|
Vidhya Bharati | On the devaluation of currency which happened in RoW markets you mentioned are, you actually changing the
strategy towards your hedging policy or will this impact flow through other quarters also how will that play
out. |
|
Kedar Upadhye | To the specific markets in which we faced this devaluation challenge were Venezuela and Belarus and we dont
believe a cost effective hedging solution is available for these markets and given that devaluation has already
happened, obviously the effect will flow through in the coming quarters. |
|
Vidhya Bharati | Okay thank you so much sir that is all from my side. |
|
Kedar Upadhye | We thank all for joining Dr. Reddys Senior Management for the earnings conference call for Q1 FY12. In case
you need any additional clarification, please feel free to get in touch with Raghav, Milan or myself. Thank you
and good evening to all of you. |
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Press Release
|
||
Dr. Reddys Laboratories Ltd. | ||
8-2-337, Road No. 3 | ||
Banjara Hills, Hyderabad 500 034 | ||
Andhra Pradesh, India | ||
Tel: 91-40-4900-2900 | ||
Fax: 91-40-4900-2999 | ||
www.drreddys.com |
* | Gemzar® is a registered trademark of Eli Lilly and Company. |
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Press Release |
Dr. Reddys Laboratories Ltd. | |
8-2-337, Road No. 3 | ||
Banjara Hills, Hyderabad 500 034 | ||
Andhra Pradesh, India | ||
Tel: 91-40-4900-2900 | ||
Fax: 91-40-4900-2999 | ||
www.drreddys.com |
* | Additional Notes on the Japanese market: |
|
| Japan is the worlds second largest pharmaceutical market, estimated to be $97b as per IMS |
|
| The Japanese generic pharmaceutical market is a very attractive one, characterized by the following: |
| Low penetration with only about 23% of Japanese prescription drug sales (by volume)
contributed by Generics as compared to 70% by volume in the US |
||
| Wide ranging government initiatives to reduce health care spending. The Japanese
government is actively promoting use of generics to alleviate patients expense and
reduce the national medical expenditure under the goal of increasing the market share
of generic drugs by sales volume to at least 30% by FY2012. |
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| Medical institutions and patients should have assurance and trust that products are
of high quality and be assured of a stable supply. |
||
| A rapidly ageing demographic profile |
||
| Comparatively high reimbursement prices In the 1st year of listing,
price of generic drugs are set at 70% of the innovator price. The price of the generic
drugs does decline faster than for innovator products, but not as fast as in other
countries such as US |
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DR. REDDYS LABORATORIES LIMITED (Registrant) |
||||
By: | /s/ Sandeep Poddar | |||
Date: August 4, 2011 | Name: | Sandeep Poddar | ||
Title: | Company Secretary | |||
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