|
BY OUR PHARMA CORRESPONDENT 30
April,2007: S
India’s top drug drug maker Ranbaxy
Laboratories has registered record profits for the
quarter ending March 2007, powered by soaring
overseas business. The company’s global sales grew
23% resulting a 79% jump in net profits to the
tune of Rs 128.70 crore from Rs 71.80 crore in the
corresponding period of last year. Earnings per
share on a fully diluted basis worked out to Rs
2.61 as against Rs 1.91 in the last period.
Emerging markets fueld 54% of global sales with
a 53% growth in Q1 2007. This segment comprises
amongst others, key countries of India, Romania,
CIS, South Africa, Central & Eastern European
nations, CIS and Latin America. The Developed
Markets, primarily USA, Canada, countries in
Western Europe and Japan recorded sales of USD 140
Mn, a growth of 7%. These markets comprise 39% of
global sales. The company's international business
recorded sales of USD 281 Mn, up 23% and
contributed 79 % to total sales successful start
in the European continent with key markets
delivering strong growth. Sales in Europe up 78%
to USD 93 Mn.
Sales in North America were at USD 91 Mn,
recording an increase of 3%. For the quarter, USA
recorded sales of USD 86 Mn, at similar levels to
the corresponding previous quarter. Ranbaxy
received approval for 4 ANDA's which included
Zolpidem Tartrate Tablets, 5 /10 mg, Sertraline
Hydrochloride Tablets 25/50/100/150/200 mg,
Amoxicillin and Clavulanate Potassium Oral
Suspension USP, 600 mg/ 5 ml and Valacyclovir
Tablets 500 mg/ 1g. The combined innovator market
size for these products is in excess of USD 6 Bn
(Source : IMS).
Amongst the most significant ANDA approvals
received recently was the US FDA approval for
Pravastatin Sodium Tablets (Pravastatin), 10/ 20/
40/ 80 mg, with a 180 days marketing exclusivity
for the 80 mg dosage strength. The total annual
market sales for all strengths stood at USD 1.19
Bn (IMS - MAT: December 2006) and for the 80 mg
alone was at USD 209 Mn. The Company expects to
garner a significant market share of the
Pravastatin 80 mg product during the exclusivity
period.
On the branded business, the key product Sotret (Isotretinoin)
became the largest selling brand in its category
garnering a market share of 36% (as against 22% in
the corresponding previous period). The 30 mg
strength has captured a 65% prescriptions market
share in its represented category(Source : IMS).
Ranbaxy, presently, has 88 ANDA's pending
approval with the US FDA. These products at an
innovator market size are valued at USD 56 Bn and
comprise a well-balanced mix of plain vanilla
generics, niche & potential First to File
products. The Company believes that it has a First
to File status on approximately 20 Para IV ANDA
filings, with an innovator market size in excess
of USD 25 Bn.
Ranbaxy in Canada achieved the 9th position
with a 1.2% market share of the total generics
market and a 13% market share in the represented
molecules (Source: IMS). During the quarter, the
Company received approval to manufacture and
market RAN(tm)-Cefprozil Tablets, 250mg and 500mg,
and RAN(tm)-Cefprozil Powder for Oral Suspension,
250mg/5mL from Health Canada. The total market
size for Cefzil(tm) in Canada was USD 25 Mn (IMS-MAT:
Dec 2006).
In Q1 2007, Europe (including Romania)
registered sales of USD 93 Mn, 78% higher than the
corresponding previous period. The improved
performance was a result of robust sales growth in
most key EU countries. Subsequent to Romania
joining the EU effective January 1, 2007, it
becomes the Company's third largest market
globally and the largest in Europe. Rest of Europe
continued to exhibit buoyant growth led by the
important markets of Spain, Italy and Poland.
Romania recorded sales of USD 37 Mn for the
quarter, registering a growth of 50%. With the
integration of Terapia into the Ranbaxy fold
having been completed, the combined entity Terapia
Ranbaxy in the quarter received marketing
authorization for 20 new products to be launched
in the coming months. It also obtained the new
Manufacturing & Import Authorization as per EU
norms and standards consequent to the alignment of
the quality systems of Terapia Ranbaxy with EU
norms. With a market share of 5.2%, Terapia
Ranbaxy is ranked 6th in the marketplace. It has
the largest field force of around 350 people and
is the biggest generics producer in Romania.
Ranbaxy’s operations in the Western Europe
countries of UK, Germany and France, recorded a
combined turnover of USD 34 Mn for the quarter,
registering a growth of 7%.
Sales in UK were at USD 12 Mn, an increase of
77% over previous year. While market conditions
remained competitive, the restructuring undertaken
in 2006, coupled with the launch of new products
have resulted in a much-improved performance. The
branded division performed well with the launch of
Easyhaler Formoterol, adding to the Company's
existing products in the respiratory segment.
Its German business recorded sales of USD 10 Mn,
an increase of 11% over the corresponding previous
period. 11 products of the Company's German
subsidiary Basics GmbH were listed with AOK,
Germany's largest health insurance Company,
representing 35% of all health insurance policy
holders in the country. The growth in Germany was
despite stagnation in the market due to the recent
regulatory changes. Based on highly competitive
costs of India based supplies, the company is able
to meet the requirements of the German market by
operating at the lower price levels which is
critical for future growth as compared with the
top ranked companies with much higher costs coming
from local setup & infrastructure.
Ranbaxy’s sales in rest of Europe were at USD
22 Mn, a growth of 46% over the corresponding
previous period. The growth was led by robust
performances in all markets including Poland,
countries of Central Europe, Spain, Italy &
Belgium. Spain registered sales of USD 4 Mn for
the quarter while Poland recorded sales of USD 6
Mn, a growth of 52%.
The Asia Pacific & CIS region recorded combined
sales of USD 115 Mn for the quarter, 32% better
than the previous year. The performance was a
result of the improved performances from all
geographies, with the CIS region and India
maintaining its strong growth momentum.
The sales for the quarter were at USD 65 Mn,
26% better than the corresponding previous period.
In rupee terms, the India region sales grew by
24%. The growth was led equally by Acute and
Chronic businesses, both growing in excess of 20%.
During the quarter, the India business launched 18
new products. Restructuring of domestic operations
in line with customer groups, coupled with high
growth contribution from several new products
introduced over the last year has fueled the
business growth for Ranbaxy in India.
During MAT period February 2007 Ranbaxy has
garnered 5.1% market share. Contribution of
Chronic therapy portfolio to total sales stood at
23.6% (Moving Quarter February 2007) as against
22.0% over the corresponding period last year.
Ranbaxy's Chronic Portfolio has grown faster than
the market. (Source: ORG-IMS, February, 2007).
The contribution of the Novel Drug Delivery
System (NDDS) portfolio to total Ranbaxy sales
stood at 8.8% (Moving Quarter February 2007) and
the Company continues to be the leader with a 7.7%
market share in the NDDS segment. (MAT February
2007) (Source : ORG-IMS, February, 2007).
Ranbaxy has 20 brands in the top 300 brands
with 9 brands featuring amongst the top 100 list.
Amongst the new products introduced over the last
one year, three of Ranbaxy's brands - Synasma
(Oral anti-asthma), Cefditran (3rd generation
cephalosporin) and Soliten (for treatment of
overactive bladder) feature amongst the Top 30
brands of the Industry (MAT February 2007).
Ranbaxy launched 6 NDDS products in the last
quarter. Two of these NDDS formulations have been
launched in the Urology segment - Niftran 100mg
Capsules (Nitrofurantoin modified release)
developed using the Company's R&D capabilities &
Eligard 22.5mg & 45mg (Leuprolide Depot),
in-licensed from QLT Inc., USA.
It launched Osovair (Formoterol + Ciclesonide)
inhalation capsules for the treatment of asthma,
in India. This product further strengthens the
Company's presence in this segment complementing
its earlier novel launches in 2006 of Osonide (Ciclesonide)
and Synasma (Doxophylline).
Recorded sales of USD 18 Mn (+61%) for the
quarter. Russia & the Ukraine belt recorded sales
of USD 9 Mn each with a growth of 71% and 51%
respectively.
Asia Pacific (excluding India) registered sales
of USD 24 mn, an increase of 33% over the previous
period. The growth in the quarter was driven by an
all round better performance from key markets such
as the Middle East, Thailand, Malaysia, China and
Japan.
The company's Global Consumer Healthcare
Business recorded sales of USD 8 Mn, a growth of
26% over the corresponding previous year. Revital,
the Company's flagship brand continues to perform
well and has garnered a market share of 76.8% in
its segment, up from 67.9% in the corresponding
previous period. The business has recorded a
healthy growth of 63% over last year (ORG - SSA
Mat Feb '07).
Africa recorded sales of USD 24 Mn, a growth of
28%. The performance was led by key markets in
Nigeria, Egypt and the countries in Central and
South East Africa. The Company's core business in
Africa (excluding the ARV business) grew at
30%..While South Africa recorded sales of USD 7 Mn,
marginally higher than the previous period. Sales
in Rest of Africa were USD 17 Mn, +42%.
Ranbaxy’s acquisition of Be-Tabs, the 5th
largest branded generics Company in South Africa
has received the necessary approval from the South
African Competition Council. The Integration team
is in place and work related to the alignment of
the IT systems, Human Resources, Marketing & Sales
and other support functions of Be-Tabs with
Ranbaxy's existing functions are being firmed up.
Brazil registered sales of USD 6 Mn for the
quarter, recording a growth of 14% over the
corresponding previous period. The Company has
maintained its Rank at # 6 in the generic market
in Brazil.
During the quarter, Ranbaxy made an entry into
Biosimilar segment by signing a global development
& marketing agreement with a strategic partner in
India, for its first biosimilar product, G-CSF (filgrastim).
Ranbaxy will commit its resources to introduce the
G-CSF product first in the EU markets and later in
the US and other countries. The worldwide market
for neutropenia treatment is in excess of USD 4
Billion, while the global G-CSF market is about
USD 1.6 Bn.
The company also signed a term sheet with
another strategic partner in India for a global
supply agreement of Peptides. The aforesaid
alliance will provide the Company with access to
the fast growing & niche therapeutic segment of
Peptides and will further strengthen the Company's
product portfolio in the complex products
category. Under the terms, Ranbaxy has the
opportunity to acquire a strategic stake of 14.9%.
On research & development front Ranbaxy filed 3
ANDAs with the US FDA and received approval for 4
taking the cumulative filings to date to 199 with
111 approvals during the quarter. In the European
Union (EU), the Company made 10 National filings
in 9 Reference Member States (RMS) and received 9
approvals in 4 RMS.
In the area of NDDR, Ranbaxy achieved a
significant milestone by entering into a multiyear
collaboration with GSK that provides Ranbaxy
expanded drug-development responsibilities and
significant financial benefits. Under the new
agreement, Ranbaxy will advance leads beyond
candidate selection to completion of clinical
proof of concept. GSK thereafter will conduct
further clinical development for each program and
take resulting products through the regulatory
approval process to final commercialization.
Ranbaxy could receive over USD 100 Mn in potential
milestone payments for a product developed by
Ranbaxy and subsequently launched by GSK in
multiple indications and up to double digit
royalties on worldwide net sales.
The joint team has recently approved the
candidate selection of a compound for Respiratory
Inflammation. Ranbaxy will take it forward to the
pre-clinical stage. The Company will progress this
drug candidate through pre-clinical studies needed
to support an Investigational New Drug (IND)
application and will be responsible for conducting
Phase I and Phase II clinical studies through to
Proof of Concept. GSK will then have the option to
conduct further development through to final
commercialization.
Also, Ranbaxy out-licensed its novel Statin NCE
molecule to PPD, Inc. USA, the world's leading
contract research organization. PPD will acquire
the exclusive worldwide license to develop,
manufacture and market the novel statin and
Ranbaxy will be entitled to receive milestone
payments upon the occurrence of specified clinical
events and also receive royalties on sales of the
drug and sales-based milestones, retaining
co-marketing rights to the compound in India as
and when commercialised.
"Robust growth across geographies driven by new
product flow in most of our key markets has been
the main theme this quarter. In particular,
stellar performances in the Emerging Markets and
the European Continent underpin the strong
numbers, declared today. I expect this growth to
continue and accelerate as we progress through the
year,"commented Mr. Malvinder Mohan Singh, CEO and
MD, Ranbaxy, in a press release.
Ranbaxy Laboratories Limited, headquartered in
India, is an integrated, research based,
international pharmaceutical company producing a
wide range of quality, affordable generic
medicines, trusted by healthcare professionals and
patients across geographies. Ranbaxy's continued
focus on R&D has resulted in several approvals in
developed markets and significant progress in New
Drug Discovery Research. The Company's foray into
Novel Drug Delivery Systems has led to proprietary
"platform technologies", resulting in a number of
products under development. The Company is serving
its customers in over 125 countries and has an
expanding international portfolio of affiliates,
joint ventures and alliances, ground operations in
49 countries and manufacturing operations in 9
countries.
BY OUR PHARMA CORRESPONDENT |
