STATE TRADING CORPORATION

Good Q4FY14 Results
BUY
V ENUS R EME DIE S
PRESCRIPTION FOR GAIN
Rating
Buy
CMP (`)
Target Price (`)
268
360
34
Retail Desk
23 July 2014
Company Description:
Incorporated in 1989, Chandigarh-based Venus Remedies (VRL) has two
manufacturing locations in Punchkula and Baddi in India and one in Germany.
Venus is a contract manufacturer of Oncological and Cefalosporine injectable
products following EU-cGMP norms.
CORP.
Upside (%)
Key Data
BSE Code
NSE Code
Reuters code
Bloomberg Code
Sensex
Face Value (`)
Mcap (` Cr.)
52 week H/L (`)
2 Wk Avg Qty
Share holding,
June’14
Promoters
DIs
FIIs
Corporates
Public
Performance
(%)
3M
Stock-VRL
-13.4
BSE 200
15.7
BSE 500
16.7
526953
VENUSREM
VENR.BO
VNR IN
26147
10
303
350/140
21000
Holding %
37.5
8.8
8.6
16.8
28.3
Its manufacturing locations are integrated and linked by high-speed networks to
deliver products to markets at the right time and price. The cGMP has been
granted for four of its facilities of oncology liquid, oncology lyophilized, dry
powder cephalosporin and dry powder carbapenem. VRL’s Baddi manufacturing
unit is accredited with multiple international cGMPs.
VRL has 9 dedicated injectable manufacturing units, a presence in 60 countries
and covering more than 75 products. VRL’s 11 overseas marketing offices include
a presence in the US and Germany, among the most demanding pharmaceutical
destinations in the world. Currently, Oncology accounts for about 30% of
revenues, Cephalosporin 32%, Infusions 14% and Small Volume Parenterals 23%.
Q4FY14 and FY14 Results:
During Q4FY14, standalone sales advanced by 13.6% to `142.3 crore and net
profit rose 17.5% to `14.1 crore despite higher depreciation and tax.
OP and NP margin stood at 23.6% and 9.9% against 23.9% and 9.6% respectively in
the corresponding period last year. EPS for Q4FY14 stood at `12.4 on enhanced
equity.
LTD
6M
11.3
25.7
27.2
12M
11.8
31.5
33.8
During FY14, sales advanced by 15.6% to `541.6 crore and net profit by 12.2% to
`64.3 crore.
OP and NP margin stood at 25.6% and 11.9% against 25.7% and 12.2% respectively
in the corresponding period last year. Consolidated EPS stood at `56.4. A
dividend of 30% has been declared.
With debts of 250 crore, the debt-equity ratio as on FY14 stood at 0.55:1
whereas the value of the gross block stood at `560 crore.
Price Chart: (One-Year)
http://www.venusremedies.com
Vijay Dave
[email protected]
Ph: 91-22-6760 7700
(GMDV)
Key Financial: (Consolidated)
Year-March
Sales
PBIDT
Interest
PBDT
Depreciation
PBT
Tax
PAT
Equity
Reserves
Book Value (`)
EPS (`)
OP Margin (%)
NP Margin (%)
P/E
Q4FY14A
Q4FY13A
142.3
33.6
7.3
26.3
9.7
16.6
2.5
14.1
125.3
29.9
6.2
23.7
8.1
15.6
3.6
12.0
12.4
23.6
9.9
10.5
23.9
9.6
(` crore)
FY12A
FY13A
FY14A
FY15E
357.3
91.4
18.7
72.7
17.9
54.8
7.3
47.5
9.1
233.3
266.4
52.2
25.6
13.3
468.6
120.5
24.6
95.9
33.1
62.8
5.5
57.3
*10.5
363.8
356.5
54.6
25.7
12.2
541.6
138.7
29.4
109.3
40.2
69.1
4.8
64.3
*11.4
446.2
401.4
56.4
25.6
11.9
4.8
603.2
153.2
31.5
121.7
40.5
81.2
7.5
73.7
**11.4
519.9
466.0
64.6
25.4
12.2
4.1
*Enhanced equity capital owing to conversion of warrants issued to promoters at
`212.20/share. The recent conversion was in June 2013.
**FCCB to be converted in equity not considered.
Venus Remedies
Venus Pharma GmbH
Venus Pharma GmbH is the primary Centre for European business of Venus in
27 EU countries, EEA members and gulf countries. This German unit, backed
up by quality innovative products from EU cGMP approved units, more than
341 patent applications globally and about 550 product registration dossiers
filed throughout the world, has the perfect time to take off. With this long
leap VRL is currently among the only three EU cGMP manufacturers of
Carbapenem Antibiotics in the world, capable of marketing this drug in
Europe.
Panchkula Plant
VRL’s first manufacturing location commenced operation in 1991. This unit
has now grown to 7.5 million bottles a year. A proactive investment in worldclass equipment and a strict adherence to best practices enable the unit to
manufacture complex and intravenous products products in the Antibiotics,
Total Parenteral Nutrition (TPN), Neuro and other super specialty
therapeutic segments.
State-of-the-art quality control laboratories ensure strict process and
product adherence with WHO-GMP and ISO 9001:2008 standards. Its key
products include Mebatic, Calridol, Moximicin, Neurotol and Glutapep,
among others.
Baddi Plant
This five-acre unit represents a prudent balance between environment
friendliness and globally-benchmarked manufacturing infrastructure. This
unit's strategic location in a special economic zone capitalises on a number
of fiscal benefits. The unit manufactures high-end novel formulations across
eight units dedicated to oncology liquid injections, oncology lyophilised,
lyophilised injections, pre-filled syringes, cephalosporins, carbapenems,
cardiology injections and liquid vials.
The unit has an annual production capacity of 78.5 million vials catering to
other high-growth, high-value therapeutic segments. The facility has a
warehousing capacity of 1,900 pallets under controlled temperature,
facilitating storage and anytime delivery.
The unit manufactures key products like Sulbactomax, Vancoplus, Potentox,
Tobracef, Supime, Zydotum, Pirotum, Ronem, Lastinem, Fejet, Actimycin,
Megaparin, Taxedol, Paclitol, Oxol, Citabol and Carplat, among others. The
unit is certified for ISO 9001, ISO, 14001 and OHSAS 18001; the unit has also
received 14 international certifications from global regulatory authorities
including European GMP valid across the European Union.
cGMP Cerifications
Three manufacturing facilities received national and international GMP
certifications. Besides, Venus' manufacturing units are certified for ISO 9001,
ISO 14001, ISO 18001 and OHSAS.
VRL has also been approved by EUROPEAN-GMP, WHO-GMP, Latin American
GMP (INVIMA), Ukrainian GMP, Zimbabwe GMP, Uganda GMP, Syrian GMP,
Columbian GMP, Kenya GMP, Yemen GMP, Saudi Arabian GMP and Iranian
GMP, Therapeutic Goods Administration (TGA) Australia among others.
Tax Benefits
Manufacturing unit in Baddi enjoys a tax holiday of 10 years; the R&D
center’s DSIR approval provides a weighted tax benefit of 200% on revenue
and capital expenditure and enables R & D material and equipment import at
zero duty.
FCCBs Conversion at `364 in Feb
2015
$5 million Zero Coupon Fully Convertible Foreign Currency Convertible Bonds
(FCCBs) are due in February 2015 and the conversion price is `364 per share.
New Launches
Trois: VRL commercially launched its new drug, 'Trois', an arthritis drug, to
tackle what is predicted to become the "biggest epidemic" in India by 2013,
with a $672 million market for rheumatoid arthritis drugs. The nano
technology-based, Trois, has many advantages, as it has got 178 per cent
faster penetration that leads to quick onset of action resulting in enhanced
bioavailability, reduction in pain and inflammation associated with arthritis.
Sunidhi Research |
2
Venus Remedies
Stermax: Stermax is a wound cleaner and universal antiseptic in Indian
market.
ACHNIL: ACHNIL launched in India to cater to the pain management segment
is expected to grow to `35 billion from its current market size of `20 billion.
An ACHNIL acts directly by giving instant relief from acute pain and is
effective for the next 24 hours against the conventional daily dose of three
injections of Diclofenac given every 8 hours.
Great Potential for ‘Vancoplus’
VRL has achieved another landmark by fetching its first patent grant from
Japan patent office (JPO) which is among the most stringent pharma markets
in the world.
This patent has been granted for its novel research product ‘Vancoplus’
which has been designed to curb the growing bacterial resistance specially
caused by the notorious MRSA strain which is usually termed as one of the
Superbugs.
VRL has received additional US patent for Vancoplus, with validity period of
till 2032. VRL has Initiated process for pre IND meeting with US FDA for fasttrack approval. Vancoplus is growing at a 4 year CAGR of 25%+, since it was
launched.
The market size of MRSA (Methicillin-resistant Staphylococcus aureus) in the
world accounts for $900 million. Presently, it is growing with CAGR of 4.8 per
cent, which is estimated to reach to $1.2 billion by 2017.
Studies indicate that the incidence of MRSA in the past few years has
extensively increased worldwide, with the prevalence of MRSA in Japan, US
and southern European countries ranging from 20 per cent and 60 per cent.
VRL intends to launch this research product in early 2015. Currently,
Vancoplus is available in emerging markets and is under registration in many
countries. Venus intends to out-license Vancoplus across patent protected
regions to major pharmaceutical players.
Mexico Patent for ‘Potentox’
VRL has received patent from Mexico for its novel antibiotic product
Potentox. Granted by the Mexican Institute of Industrial Property (IMPI), the
patent protects the composition of Potentox. The patent provides an
exclusivity period for Potentox up to 2025. Potentox is a novel antibiotic
adjuvant entity effective against quinolones and aminoglycoside resistant
gram negative infections.
The drug is also protected by a number of other patents from various other
countries, including USA, India, Australia, New Zealand, South Korea, South
Africa, Canada and Ukraine. Mexico spends about 70% of its health budget on
extra costs incurred due to hospital-acquired infections.
Potentox is an antibiotic adjuvant entity (AAE), a drug effective in case of
hospital-acquired pneumonia and febrile neutropenia infections, primarily
caused by quinolones or aminoglycoside-resistant microbes. Venus is upbeat
about the response Potentox has received in the domestic and global
markets.
The global hospital-acquired bacterial infections market was estimated to be
worth US $9 billion in 2010. Potentox is designed to address the needs of
almost 50% of this market. The hospital-treated infections market is
projected to grow at a rate of 2.7% annually in major economies.
Marketing Rights Deal With Adcock
VRL has signed deal with Adcock to give exclusive marketing rights of
Potentox in South Africa’s 2nd largest pharma major Adcock over the period
of 15 year.
The product will remain under patent protection till 2025 in African territory
and is expected to be launched by mid of 2015 after getting due regulatory
approvals.
Sunidhi Research |
3
Venus Remedies
Japanese Patent for 'Elores'
Marketing Approval of ‘Elores’ in
Myanmar
Exclusive Marketing Rights Deal with
South Korean Pharma Major
This novel antibiotic adjuvant entity (AAE) has been found effective against
most resistant CRE (carbapenemase resistant enterococci). VRL is expected
to launch this product in Japan, world’s second largest pharmaceutical
market next to the US, by the end of 2015. The Japanese patent has given
exclusivity for the product in one of the world’s most important and
lucrative healthcare markets up to 2025.
VRL has received patents for this product from 46 countries, including the
US, Australia, New Zealand, Russia, South Africa, South Korea, India and all
major economies, including EU constituents. VRL expects this product to
generate revenue of around $100 million (`600 crore) by 2018.
VRL has received the marketing approval for blockbuster Elores for Myanmar,
which will be launched in next few months. Elores is a drug designed to fight
`superbugs’ to which other antibiotics fail to respond. The company has
patent for the product, method of treatment & use from 47 countries
including US, India, Australia & Europe.
VRL has signed deal with Korean pharma giant Goodwills Co. for exclusive
marketing rights of Elores after grant of patent by Companies and
Intellectual Property Registration Office (CIPRO) from Republic of South
Korea.
Goodwills is planning to launch this product in mid of 2014 post regulatory
approval from Korean FDA for which the dossier is already under evaluation.
Bridging clinical trial on Korean population are being conducted in 6 leading
hospitals of Seoul, the capital city of South Korea.
The overall pharmaceutical market of South Korea is approximately US$20
billion, growing at CAGR 6.5%, out of which antibacterial market is around
US$ 2 billion , thus making it one of the largest segment. Elores is designed
to address a 15% of this segment (near US$ 300 million) where company is
hopeful of capturing 15% market share within 3 years of its launch making it
over USD 45 million product in South Korea.
Launch of First OTC-'Ezenus'
VRL has launched its first OTC product 'EZENUS', a stress reliever. EZENUS is
a patent protected herbal, anti-stress formulation based on German
Technology. It is a strong detoxifier candy free from side effects, with strong
antioxidant, hepato-protective, and immune boosting activity which reduce
stress without altering the physiological functions of the body.
It is world’s first anti stress product launched in easy to use candy form even
suitable for diabetic patients. It is highly safe in acute stress management
such as exam stress in children and in chronic stress like in alcoholic and
smoking population, without change in life style by continuous detoxification
and strong antioxidant activity.
EZENUS reduces more than 60% stress within 30 days without change in life
style and significantly improves the quality of life in terms of physical,
social, emotional and functional well- being. This breakthrough innovative
product is suitable for all ages with safety established upto 10 times advised
dose.
VRL is hopeful that this novel research product 'EZENUS' will acquire 5% of
the 100 million USD direct market of stress segment in India, other than
lifestyle disorders, within 3 years of its launch. VRL will use its existing
network of 50,000 pharmacists to distribute this product on pan-India basis.
Further, an aggressive promotional campaign will be undertaken for
broadening its reach.
'Meropenem’ Market Authorization
in Mexico
Sunidhi Research |
VRL has received grant of market authorisation from COFEPRIS, the Drug
Regulatory Authority of Mexico, for its Meropenem 500mg and Meropenem
1000mg in Mexico. It plans to launch its first product in the market within
the first quarter of fiscal year 2014.
4
Venus Remedies
Market authorization for Meropenem will enable VRL to launch its first
product in Mexico and will strengthen its position in Latin America where VRL
is currently exporting to various countries of LAC such as Columbia, Peru,
Guatemala, Dominican Republic, Jamaica, Bahamas and the Caribbean.
VRL is hopeful of capturing 10% of the market share within the first 3 years
of its product launch. At present, Meropenem sales account for US$16.3
million in Mexico, of which, major share of 80% is with innovator’s product
“MERREM” and rest with other local companies.
Launch of ‘Meropenem’ in Australia &
Venenzuela
Meropenem is being launched in Australia and Venezuela in the near future
in tie up with Lupin Ltd. Strategy in place to capture sizable share within 1st
year of launch in the $10mn Venezuelan market and $15mn Australian
market.
VRL is set to expand market share with 35 MAs from various countries in the
global target market of $1.3 billion. VRL is in the process of extending its
footprint and sales operations in the most of other regulated markets like
Canada and Switzerland.
Aims 3-4% in Anti-Infective Drugs in
Europe
VRL aims at a 3-4% share of the $300 million market of this particular antiinfective drug in Europe. Two anti-cancer drugs also will be sold through
alliances. Venus is looking for partners in 18 European countries.
Recently, the company's wholly owned subsidiary, Venus Pharma GmbH,
Germany received permission to market meropenem, a carbapenem injection
in the European Union, through the registration in Portugal.
Meropenem is used to treat life threatening infections caused by bacteria.
Meropenem was originally developed by Sumitomo Pharmaceuticals and is
marketed in Europe including Portugal by the brand name of Merrem by Astra
Zeneca. The patent for this product has recently expired.
Strong Growth in R & D
Venus Strengths
Sunidhi Research |
-One of the few pharma companies in India with complete focus on
innovation and R&D
-Focussing on unmet medical needs with life threatening implications to
develop innovative research products
-Received 100+ patents, 70 trademarks and 9 copyrights for its R&D based
products across the globe
-Pipeline of 25 innovative products; commercialized 15 products in domestic
and international market
5
Venus Remedies
-Strong R&D focus on high growth anti microbial resistance and Oncology
segments
-Developed expertise in key technologies like Novel drug delivery system and
nano-technology
-Venus Medical Research Centre in Baddi is a DSIR approved and GLP
certified research centre, to become one amongst the 8 pharma companies
in India
Growth Products
Sunidhi Research |
6
Venus Remedies
Key Competencies
Mission 2015
-To establish VRL as an innovator company
-Create intellectual property wealth of US$1 billion
-Ensure commercialisation of intellectual property rights worldwide
-Establish Sulbactomax as a `1 billion brand
-To ensure presence in 60 countries
-Make every department an independent profit centre
-Achieve new heights by the creation of a Venus Industrial Complex
-Develop and sustain a highly motivated and empowered team for realisation
of self progressive society dream
-To be a globally-admired pharmaceutical company respected for world-class
quality and innovation
Outsourcing Opportunities
The global life sciences manufacturing outsourcing opportunity was
estimated at around US$20 billion and was expected to have reached US$31
billion in 2010. India has emerged as a hub for global players due to the
availability of world class facilities and quality products at competitive
prices. In the R&D sector, the value of the outsourced business was expected
to be about US$7.5 billion by 2013.
CRAMS has Great Potential
Currently, India’s contribution to the global CRAMS markets accounts to
about 3% and this is expected increase substantially in the next 5 years.
While the overall CRAMS business worldwide is estimated at $25 billion and it
targets $31 billion by 2011. In fact, Indian CRAMS segment is estimated to
have earned revenues of approximately $895 million in 2006 and was
expected to have reached to close to US $8 billion in 2015.
Prospects
The domestic pharmaceutical industry currently pegged at $20 billion
(`1,210 billion) is expected to touch $55 billion (`3, 327.5 billion) by 2020
with a CAGR of 15-17% indicating a scorching growth. (McKensey). There has
been a huge export potential for the Indian pharmaceutical industry. The
exports of drugs and pharmaceuticals grew by 25% (YoY) to $14.6 billion
(`883.3 billion) in FY13. The exports are expected to have reached $14.84
billion (`897.8 billion) in FY14.
Emerging markets currently represent 16% of the global market (source: IMS
Health), but are expected to have contributed 40% of growth in 2014. India
produces 20% of generic drugs in the world and is the third largest producer
of drugs and 14th largest by volume. Overall, it was expected that the Indian
Pharmaceutical Industry would grow by 11-12% in FY14 from 13.5% in FY13.
Sunidhi Research |
7
Venus Remedies
Great Potential For Indian Pharma
Market
Source: McKinsey analysis; secondary research
Growth Drivers
India’s per capita health expenditure is a low US$43 compared with US$142
in China and US$7,536 in the US. This is expected to correct consequent to
GDP growth, increase in disposable incomes and growing health awareness.
Per capita income: The number of households with incomes above US$5,000
per annum is expected to increase at an 18.8% CAGR from 14.4 million to
63.8 million by 2015 (Source: McKinsey Global Institute).
Household population with an annual income of US$2,250-5,000 will stand at
106 million. Increased income will provide easier access to medicinal
remedies.
Rural prosperity: India’s per capita rural income of `19,000 is expected to
increase to `24,000 by 2015 (Source: McKinsey), which should enhance
pharmaceutical spending. Demographics: Working age group population (3060 years) is expected to increase from 32% in 2007 to 36% in 2026, sustaining
the uptrend in lifestyle diseases.
Besides, India’s ageing population (over 60 years) is likely to increase from
7.5% in 2007 to 9% by 2026. Growing health infrastructure: India’s 5.8
doctors per 10,000 are lower than the global average of 12.3.
EM the Fastest Growing in
Pharmaceuticals
Sunidhi Research |
The government embarked on an initiative to build medical infrastructure,
allocating US$1.23 billion for six upcoming AIIMS centres. India’s hospital
market is expected to grow to US$14 billion by 2020 from US$1.7 billion in
2009, which will drive pharmaceutical consumption.
The emerging markets represent the fastest growing segment of the Global
pharmaceutical industry. As per industry estimates, the total spending on
healthcare in these markets is likely to grow from US$151 billion to $285-315
billion by 2015 with most markets expected to grow at double digit.
Apart from the developed markets, the Indian Pharma companies have also
been eyeing growth opportunities in some of the other fast-growing emerging
markets. Among them, in Russia, South Africa and some of the countries in
Latin America (Brazil, Mexico) and South-East Asia, Indian companies have
strengthened considerable presence.
Given absolute GDP of $9.1 trillion USD in 2009 and a pharmaceutical market
that is estimated to drive $40 billion USD in growth through 2013. China is
leading the pharmerging markets.
8
Venus Remedies
A landmark $125 billion USD incremental government funding is at the heart
of the healthcare transformation, targeting substantial improvement to the
nation’s healthcare infrastructure, a move which is projected to double the
size of China’s pharmaceutical market by 2013. Driven by aggressive
government spending on healthcare and an increasing demand for drugs to
treat chronic illnesses, China’s pharmaceutical market expanded at an
astonishing 20% in 2009.
Given a GDP of $2-4 trillion USD in 2009, Brazil, Russia and India were each
expected to add $5-5.5 billion-$15 billion USD to the pharmaceutical market
through 2014. During the initial phase, most of the Indian players preferred
acquisitions/in-organic investments to enter into these markets are now
enhancing their presence through ramp up in product portfolio and therapy
segments.
In addition to direct presence, Indian companies have also been partnering
with MNCs in emerging markets. Such alliances benefit from the R&D and
manufacturing capabilities of the Indian partners and the extensive
marketing & distribution footprint of the MNCs in those markets.
Global Pharmaceutical Potential
In the long run, the global pharmaceutical market is expected to grow at a 58% CAGR through 2015, taking into account the impact of the changing mix
of innovative and mature products and the rising healthcare access in
emerging markets, and on the other hand, the price pressure by regulators in
developed countries.
Consequently, the global pharmaceutical market was expected to expand to
$1.1 trillion USD by 2014. The pharmerging countries are expected to grow
by 13-16 percent over the next five years. China's pharmaceutical market is
expected to continue to grow at a pace of more than 20% annually.
Patent Cliff Potential
Patent cliff describes what happens to the sales of an original drug when its
protection (patent, regulatory, etc.) ceases: A dramatic drop in sales both
due to declining unit numbers, but also a price erosion of up to 70% within
months. Patent cliff will fundamentally impact individual pharma companies
in the mid-term future.
During the five-year period (2010-2014), the revenues of drugs having
patents that expired are about US$89.5 billion, the majority of them small
molecules. (In the five-year period from 2005-2009, this value was US$90.5
billion).(Source: An IMAP Healthcare)
Oncology-A Special Case
Cancer has rising therapeutic and commercial importance, as more than 20
million new cases of cancer are predicted in 2025, compared with 12 million
in 2008.
The oncology drug market has grown impressively, driven by expanding
patient populations and technological advances, especially in biomolecular
medicine. Current treatments are better tolerated and more effective than
ever before. The innovative products on the market will drive double-digit
annual growth in the upcoming period.
With this positive scenario, global sales of cancer drugs grew at a CAGR of
12% to 15%, reaching $75-80 billion US$ in CY12 from $48 billion US$ in 2008.
The growth was expected to sustain going forwad.
The factors that are driving the tremendous growth include the increasing
number of cancer patients on chemotherapy in Europe, Japan and North
America, i.e., mainly developed markets, and more patients in emerging
markets gaining access to modern targeted therapies.
Currently, around 70% of the revenues come from the US and Europe’s top
five markets, namely, France, Germany, Italy, the UK and Spain. (IMS
Health)
Sunidhi Research |
9
Venus Remedies
Valuation & Recommendation
VRL is present in 60 regulated and semi-regulated countries, actively
exporting to around 30 countries. Venus has a broad range of products
catering to critical care segment in parenterals like cephalosporins,
carbapenems and oncology drugs in lyophilized form, infusions and small
volume parenterals. VRL has bagged 85 patents across the world for its
research products.
Contract manufacturing opportunities with leading global brands,
registrations approved in many semi-regulated markets, launch of innovative
products in domestic and international geographies (through marketing
alliances) and entry in new global geographies through regulatory approvals
(namely Thailand, Malaysia, the Philippines and Syria) and various mew
launches are expected to grow its international business and give strong
visibility to revenue & profitability going forward.
At the CMP of `268, the share is trading at a P/E of 4.8x on FY14A and 4.1x
on FY15E. We recommend BUY with a target of `360 at which, the share will
trade at a P/E of 5.6x on FY15E.
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