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www.aurobindo.com |
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Hyderabad, 30th July, 2005 |
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AUROBINDO POSTS REVENUE OF
RS.2807 MILLION IN Q1.
SALES, PROFITABILITY DAMPENED DUE TO VAT FALLOUT.
REGISTERS GOOD MOMENTUM ON EXPORTS TO THE US/EU
IMPROVING DOMESTIC MARKET BUSINESS |
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Aurobindo Pharma Limited has registered a total
income of Rs.2807 Million (Rs.2849 Million) and
a net profit of Rs.20 Million (Rs.180 Million)
for the quarter ended June 30, 2005. |
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Sales and profitability were lower during the
quarter, primarily on account of a delayed
revival in domestic markets and pressure due to
accumulated stocks at market place as fallout of
VAT. Domestic formulation companies have come
back to normalcy in off take of APIs by the
middle of the quarter. This can be seen from the
Company's monthly total sales pattern i.e.,
April 05 - RS. 745 Mn, May 05 - RS. 940 Mn, June
05 - RS.1122 Mn. The domestic and export break
up stands at 44% (55%) and 56% (45%) during this
quarter. |
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Exports grew at 22%, with sales to North
America/Europe showing a growth of 300%. North
America/Europe registered sales of Rs.515 Mn
(Rs.129 Mn). The Company commenced the marketing
operations successfully in the USA by attracting
senior marketing personnel with vast experience
in MNCs like Sandoz, Baxter, etc. The first
three approved products are already marketed in
the US. |
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The cost - revenue mismatch continues as the
returns on investments done for regulated
markets are expected to catch up in the second
half of the year. |
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During the quarter, Aurobindo Pharma continued
to invest in the building blocks for a
successful regulated market strategy. A number
of key milestones were crossed. |
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During the quarter the Company, |
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filed 6 ANDAs in US, 4
dossiers in Europe and 5 dossiers with WHO
taking the total filings in the quarter to
15. |
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filed 5 DMFs in US, 4 DMFs/CoS
in Europe taking the total DMF filings in
the quarter to 9. |
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filed 24 patents. |
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obtained 5 approvals for ARVs
from US FDA such as Lamivudine, Stavudine,
Efavirenz, Nevirapine and
Lamivudine+Zidovudine enabling the company
to participate in PEPFAR program of USA. |
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obtained 3 eDMF/CoS approvals
for APIs. |
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obtained WHO compliance for
Unit III enabling the company to participate
in ARV sourcing programs of WHO. |
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obtained approval from Health
Canada, the regulatory agency of Canadian
Government, for the sterile and non sterile
formulations/APIs of Unit VI for
cephalosporins and Unit III for other
formulations. |
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complied with US FDA for its
Bioequivalence center and received the
product approvals wherein the bio-studies
are conducted in this center. |
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recruited 72 more personnel
in its R&D /formulation operations. |
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strengthened the emerging
markets team by converting it as a SBU and
recruited a top management person to head
the team. |
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The cumulative filings of DMFs/ANDAs/Patents
are as follows: |
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USA |
EU/Others |
Total |
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DMFs |
34 |
55 |
89 |
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ANDAs/Dossiers |
25 + 5 * |
23 |
53 |
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Patents |
15 |
124 |
139 |
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*
JV filings |
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The year 2005-06 is going to be a very eventful
year with commercialization of the regulatory
approvals in the generic formulations business. |
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Some of the key drivers are: |
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further product approvals
filed from Unit III for US market |
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expected product approvals
filed from Unit VI (Cephalosporins Facility
approval is already in place) |
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anticipated inspections and
approvals for products filed from Unit XII
(Semi-synthetic penicillin’s. Filings are
already done), |
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anticipated inspections and
approvals for products filed from USA JV
facility (Sterile cephalosporins. 4 ANDAs
are filed), |
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expected approvals for
formulation dossiers in EU/Canada/S.Africa |
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participation in PEPFAR/WHO
programs |
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The company believes that the momentum will
catch up by third quarter of FY 06 onwards, due
to the above growth drivers. |
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About Aurobindo Pharma Limited: |
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Aurobindo Pharma Limited (www.aurobindo.com),
headquartered at Hyderabad, India, manufactures
generic pharmaceuticals and active
pharmaceutical ingredients. The company has
received approvals for several facilities from
leading regulatory agencies like US FDA, UK MHRA,
WHO, Health Canada, MCC South Africa. The
company’s robust product portfolio is spread
over 6 major therapeutic/product areas
encompassing (Antibiotics, Anti-Retrovirals,
CVS, CNS, Gastroenterologicals, and Anti-Allergics)
around 65 APIs in the non-antibiotics and 55
APIs in the antibiotic segment. The Company is
marketing these products globally, in over 100
countries. |
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A large Infrastructure supports the operation
(as in table). |
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* RM-highly regulated markets |
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* LRM-less regulated markets |
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Unit |
Target market* |
Facility |
Approvals |
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R & D Centres
- Hyderabad
- Mumbai
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Hyderabad |
RM
RM
RM |
Chemical/Formulation Research
Formulation Research
Clinical Pharmacology & Bio equivalence |
US FDA |
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Unit –
I A
Unit –
I B |
RM
RM |
APIs
CVS drugs, CNS drugs, anti allergics and
other life style drugs
APIs
Cephalosporin-Oral. |
US FDA
US FDA |
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Unit – II |
LRM |
APIs |
CGMP |
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Unit – III |
RM |
Multiple blocks – oral dosage Formulations |
USFDA, UKMHRA, South African MCC, Brazilian
ANVISA, WHO, Health Canada |
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Unit – V A
V B
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LRM
RM
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APIs-Betalactams
APIs-SSPs sterile
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CGMP
Awaiting regulatory inspections |
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Unit - VI A
Unit - VI B
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RM
RM
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APIs-Cephalosporins
Sterile& oral dosage formulations –
Cephalosporins
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Compliance with Health Canada. Filed DMFs
with USFDA and waiting for inspections.
South African MCC, Brazilian ANVISA, CGMP,
USFDA (Oral & Formulations), Health Canada |
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Unit - VII |
LRM |
APIs |
CGMP |
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Unit - VIII |
RM |
APIs |
USFDA, CGMP |
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Unit - IX |
LRM |
APIs |
CGMP |
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Unit - X |
LRM |
Drug Intermediates |
CGMP |
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Unit – XI A
XI B
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LRM
RM
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APIs
APIs
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CGMP
Awaiting regulatory inspections |
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Unit – XII |
RM |
Sterile & oral dosage formulations SSPs |
South African MCC, Brazilian ANVISA, cGMP,
other Regulatory inspections awaited |
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China Bio Pharma
TongLing |
RM/LRM
LRM |
Intermediates
APIs-Betalactams |
CGMP
CGMP |
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Cephazone, JV, USA |
RM |
Sterile cephalosporin formulations |
ANDAs filed and waiting for Approvals |
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PRESS
ROOM
