Re: {LONGTERMINVESTORS} Unichem labs.......thread

[RAJESH DESAI]

report atcd.


--
CA. Rajesh Desai

[RAJESH DESAI]

Unichem Laboratories advances on receiving USFDA approval for Irbesartan Tablets

Unichem Laboratories has received ANDA tentative approval from the United States Food and Drugs Administration (USFDA) for Irbesartan. Final approval will be received after the patent expires on Dec 7, 2015. 

Irbesartan Tablets 75mg, 150mg and 300mg are therapeutically equivalent to Avapro Tablets 75mg, 150mg and 300mg from Sanofi Aventis US, LLC. Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

The product will be commercialized (after the final approval) from Unichem's Ghaziabad plant, Active pharmaceutical ingredient i.e., Irbesartan used for this ANDA is also made in house at Pithampur plant. The current market size is $450 million.

Unichem Laboratories, incorporated in 1962, is engaged in manufacturing formulations, pharmaceuticals and active pharmaceutical ingredients (APIs). The company was promoted by the late Amrut Mody, a pioneer in the Indian pharmaceuticals business.

On Thu, Oct 4, 2012 at 1:41 PM, Rekha Natarajan <rekhana...@gmail.com> wrote:

profit booking is seen as it has risen too fast. Nothing wrong with Unichem.

On Thu, Oct 4, 2012 at 1:01 PM, streetking kaushal <streetki...@gmail.com> wrote:

Why is Unichem down today?


--
Streetking

--
CA. Rajesh Desai

[RAJESH DESAI]

Press release - pfa
--
CA. Rajesh Desai

[RAJESH DESAI]

Results: Unichem Labs Q2 net profit rises 84% to Rs 35 cr Unichem Labs' net profit rose by 84% to Rs 35 crore in the second quarter of FY13 from Rs 19 crore in the corresponding quarter of last fiscal.



--
CA. Rajesh Desai

[RAJESH DESAI]

22-Oct-12

Unichem Labs

3.30 PM

91 22 6629 0368 / 3065 0146

Concall


--
CA. Rajesh Desai

[RAJESH DESAI]

Mon, Oct 22, 2012 at 13:00

Hope to sustain export margins in FY13: Unichem Lab

Rakesh Parikh, VP Finance & CFO of Unichem Laboratories said exports are driving its revenue growth. Going forward, he hopes to maintain the export margins for the rest of the financial year.

Unichem Laboratories  reported an 84 percent rise in net profit to Rs 35 crore in the second quarter of FY13 from Rs 19 crore in the corresponding quarter last fiscal. The company's net sales jumped 32.6% to Rs 261.2 crore from Rs 197 crore during the same period.

Rakesh Parikh, VP Finance & CFO of Unichem Laboratories said exports are driving its revenue growth. Going forward, he hopes to maintain the export margins for the rest of the financial year. Parikh further informed that the current capacity utilization at the Ghaziabad plant is at 90-95%.
 
Here is the edited transcript of the interview on CNBC-TV18.

Q: It has been a good set of numbers this time around for you all with a growth of around 34 percent on a year-on-year basis. Just breakup how exactly the domestic formulations business did as well as the export business? Was it the domestic formulations that led the growth like the previous quarter?

A: It was domestic formulation which has continued the performance in first quarter as well as in the second quarter, growing year-on-year at 20 percent. For both the quarters we have had this, though in terms of the top-line it is exports which have been driving the growth, though on a smaller base.

The exports are up by more than 70 percent with international formulations higher by 75 percent. Geographically, this has been primarily driven by the US business. Our sales against the Abbreviated New Drug Applications (ANDA) which we filed, got approved and launched as well as the contractual business which we are doing for a large number of generic companies.

But, the margins have been much higher because a major part was coming on account of that. The transformational exercises which we started the year before last and continued  last year has helped us to show results and the India formulation is a major beneficiary of this exercise. It has resulted in a much higher margin which has now crossed 20 percent with the PBT being 78 percent more and PAT up 83 percent.

Overall, it has been a good set of numbers and has been repeated again for the second quarter as far as the current financial year is concerned.

Q: One thing which I wanted to focus on was the trajectory of growth for the domestic formulations business. One key thing which a lot of analysts are watching out for is basically the Indore facility to commence operations and besides that if you could just take us through the Ghaziabad facility which also commenced operations recently. What sort of capacity utilisation are you working at? Is it at optimum utilisation and what is the trajectory we can expect for the domestic business?

A: Our domestic plants are basically being catered thorough from Baddi as well as Sikkim. Our Ghaziabad plant has got the approvals of US Food and Drug Administration (USFDA), Medicines and Healthcare products Regulatory Agency (MHRA), European Directorate for the Quality of Medicines (EDQM), World Health Organization (WHO) and it started operation last year, primarily on the contractual business with a very large generic company for the US market. As a result, it is now running at almost 90-95 percent capacity utilisation on a single shift basis.

Indore is a Special Economic Zone (SEZ) which is approved by the Madhya Pradesh Audyogik Kendra Vikas Nigam (MPAKVN) and that project is also near completion. The equipments are being validated. Once that is over, the trial runs will commence and will take another couple of months. Then we will have to go in for the approvals.

Q: The earnings expectations this year is fairly aggressive. You did Rs 8.70 last year. The expectation is around Rs 12 and then Rs 14 in FY14. Will you be able to deliver that much?

A: Yes, it should be possible. Though, Q3 is basically a healthy quarter in terms of businesses, our confidence level is high after two quarters’ of good performance. Exports have more or less come at a level where we should be able to sustain in Q3 and Q4. There is a lot of optimism that we should be able to achieve those kind of numbers and results.

--
CA. Rajesh Desai

[RAJESH DESAI]

PFA

--
CA. Rajesh Desai

[RAJESH DESAI]

[RAJESH DESAI]

[Rajesh Desai]

Unichem Labs gets US FDA nod for muscle relaxant Tizanidine

Pharmaceutical company Unichem Laboratories has received abbreviated new drug approval (ANDA) from US Food and Drugs Administration for a copy of Tizanidine tablets, used as a muscle relaxant. The news sent its shares up over 2 percent in afternoon trade.

Pharmaceutical company Unichem Laboratories  has received abbreviated new drug approval (ANDA) from US Food and Drugs Administration for a copy of Tizanidine tablets, used as a muscle relaxant. The news sent its shares up over 2 percent in afternoon trade.

The drug is used to help relieve, although not cure, muscle spasms caused by medical conditions such as multiple sclerosis or injuries to the brain or spine, it said.

Unichem's Tizanidine tablets in 2mg and 4mg strength are therapeutically equivalent to Zanaflex tablets marketed by Acorda Therapeutics.

The current US market size for the drug is USD 70 million, growing at 5 percent in value terms and 10 percent in volume, the company said.

The product will be commercialised from Unichem's Goa plant. The ANDA is also made at its Roha plant.

--
CA. Rajesh Desai

[Rajesh Desai]

--
CA. Rajesh Desai

[Rajesh Desai]

Rakesh Parikh, CFO, Unichem Laboratories says the new drug pricing policy affected the company’s domestic growth. The drug firm reported a 3.22 percent increase in net profit to Rs. 36.2 crore for the quarter ended September 30 as sales rose. The company had posted a profit of Rs. 35.07 crore in the corresponding quarter of the previous fiscal, Unichem said in a filing to the BSE. The US market has shown good growth this quarter, Parikh says adding, emerging market growth has been steady this quarter. Unichem has got US FDA approvals for four plants, but Parikh says, the timeline of approvals from the health watchdog has been extended. Unichem Laboratories is present in therapeutic areas such as gastroenterology, cardiology, diabetology, psychiatry, neurology, anti-bacterials, anti-infectives and pain management, among others. Below is an edited transcript of the interview on CNBC-TV18 Q: Your revenue growth has been quite muted, just about 2 percent. Is that going to be the trajectory or was that a bit of a one-off? A: We have seen that happen in the first quarter and that time also we had indicated it. One of the major reasons is the new pharma policy that got implemented at the end of the first quarter so the prices started effective on the second quarter. So, looking at that if you see the entire industry per se had a beating and that had two impacts. One is on the prices, which were down almost by 20-30 percent and in some cases even more of the products which were notified by the drugs price control order (DPCO)-13. Second is since the margins were brought down, the trade in some of the states raised lot of issues by which there was a significant destocking and not resorting to purchases because their margins got significantly reduced when these products came under National List of Essential Medicines (NLEM). It was an industry phenomenon, which has affected our India business. It accounts for more than 60-65 percent of our total turnover. However, our international business as far as US is concerned, the emerging markets are concerned, they have been able to show a good growth and that has offset whatever impact because of the NLEM has come in the domestic market, in fact if you remove the NLEM impact then the growth would have been even higher and we accept this slowly to get resolve and things to improve from here for India business. Q: With regards to the domestic business, earlier estimates had indicated around 7 percent growth for FY14. What would you target as for the second half of this fiscal and totally now? A: It all depends on the market growth hours and looking at our current performance vis-à-vis the market it should be possible what you have said and I wouldn’t be surprise if it starts picking up from the Q4 onwards and it may even end up on a higher note because the inventories in stocking system has come down, the NLEM pricing impact which is a one time hit which is a structural adjustment downside has already happened and whatever action we have taken in terms of production improvement, launching new products and further penetration in terms of getting more out of our people and marketing spend and all, should start showing better results and it should improve further from here. So, what you said is quite possible, even right now in spite of NLEM we have had small growth in India business also.

Read more at: http://www.moneycontrol.com/news/results-boardroom/us-showing-good-growth-ems-steady-unichem-labs_973128.html?utm_source=ref_article

On Mon, Oct 21, 2013 at 10:30 AM, Rajesh Desai <stock...@gmail.com> wrote:

Concall today at

 3:30pm: Unichem Laboratories, Dial nos. 022-66290302/30650102.

--
CA. Rajesh Desai

--
CA. Rajesh Desai