Vivimed Labs Limited has informed the Exchange regarding Investor Presentation
Leveraging Global Presence
Partnering Innovation
Delivering Affordable Chemistry
Vivimed Labs Ltd
Investor Presentation – March 2019
Disclaimer
Certain statements in this document may be forward-looking statements. Such forward-looking statements are subject to certain risks and uncertainties like government actions, local political or economic developments, technological risks, and many other factors that could cause actual results to differ materially from those contemplated by the relevant forward looking statements.
Vivimed Labs Limited will not be in any way responsible for any action taken based on such statements and undertakes no obligation to publicly update these forward-looking statements to reflect subsequent events or circumstances.
page 2
1 Business Snapshot
2 Sector overview
3 Our Business
Leveraging Global Presence (UQUIFA & SONEAS)
Table of Content
Partnering Innovation
Delivering Affordable Chemistry
Specialty Chemicals Business
4 Financial Performance
page 3
Vivimed at a Glance
Bulk generics
Capsules and tablets
API DIVISION
CDMO DIVISION
Niche generics
New generics
1
2
1
7
Ethical products
Ointments
Bulk generics
Niche generics
New generics
Ethical products
Anti-ulcer
Antibiotic
Antifungal
Antiviral
Antihistamine, sedative, hypnotic
Anti-depressant
Antiparasitic agent (veterinary)
Analgesic
Anti-convulsant
Anthelmintic
Anti-Hypertensive
Anti-parkinsonian
Antihistamine, Antipsychotic, Anxiolytic
Mydriatic
Vasodilator
Anti-ulcerative
Skeletal muscle relaxants
Bone resorption inhibitor
Analgesic/Narcotic
Calcium channel blocker
Syrups and liquids
Nasal sprays
FDF DIVISION
Branded Generics
# Filings
page 4
Vivimed Labs in Numbers
1991
Year of Foundation
2000+
# of Employees
12
# No. of Facilities
6 # R&D Facilities
APIs, FDFs, and Specialty Chemicals Product Portfolio
Across 3 Continents ( Europe, Asia, North America) covering 5 countries Market Presence
`11,857 Mn Revenues (FY18)
`2,216 Mn EBITDA (FY18)
`761 Mn PAT (FY18)
page 5
Business Snapshot
page 6
Key Developments - Milestones
2011
2013
2015
2017
2018
UQUIFA
Actavis Pharma
•$ 55 Mn acquisition •Added depth to the API portfolio •Enabled servicing European & American market effectively
•Rs. 122 cr acquisition •Provided access to regulated market – FDF business •USFDA approved facility with a capacity to produce 1.2 bn Solid Oral Dosages p.a.
Soneas Acquistion
•€ 15 Mn acquisition •Transformed UQUIFA into an end-to-end solution provider •Offered access to new / untapped geographies
Divested Personal care Division
•Divested part of Specialty Chemicals business for an EV of Rs. 380 cr •Divestment follows Company’s strategy of focusing on core Pharmaceuticals business
Investment by Orbimed
•$ 50 Mn Investment in Mascerene, overseas subsidiary •Fund Deployment - Debt reduction & Development of API business •Investment testament to Company’s proven track record
JV with Strides
•50:50 JV with Strides to develop and commercialize various ANDAs in US •Vertical Integration of APIs & exploitation of mutual formulation capabilities •Looking to achieve 5 ANDAs per year from this JV in the complex generics space
page 7
Our Distinguished Clientele
page 8
Management Team
DR. V MANOHAR RAO
Chairman
SANTOSH VARALWAR
Managing Director & CEO
SANDEEP VARALWAR
MARK I ROBBINS
Executive Director & SBU – Head FDF
CEO - UQUIFA
•
•
•
Conceptualized and started ‘VVS Pharmaceuticals and Chemicals Private Limited (“VVS”)’, (which now stands merged with Vivimed Labs Limited).
Retired as Joint Director of The Veterinary Biological and Research Institute (VBRI).
Post- graduation in Veterinary Sciences from Edinburgh University, U.K. and has more than 30 years experience in The Municipal Corporation of Hyderabad and Department of Animal Husbandry, Government of Andhra Pradesh (India).
SAURABH SG Executive Director - UQUIFA
•
•
9+ years of past experience in Investment Management
B.E. degree in Mechanical Engineering, MBA in Finance & International Business; pursued courses in ‘emerging business leadership’ at the IIM, Bangalore, London Business School and INSEAD, Paris
•
•
•
First generation entrepreneur
Business growth strategy and leadership; Focus on key global Client relationships
Previously associated with Shipping Corporation of India
• Associated with Vivimed since its incorporation and leads Vivimed’s Healthcare FDF division
• Over 19 years of experience in
manufacturing and marketing in the Healthcare industry
• Mr. Robbins has been the CEO of
UQUIFA since 1990
• Has had experience managing other
chemical and pharmaceutical companies for 20 years
• Holds a BSc (Hons) in Genetics and an
MBA
RAMAKRISHNA CHUNDURI Member of Advisory Board
JOZSEF REPASI Managing Director - Soneas
• Qualified Chartered Accountant and Cost
• More than 25 years of experience in
Accountant
•
Finance professional with varied experience in finance and management over a few decades.
• Associated with several companies
including DEL, Matrix Labs, Maa TV etc and served as a director in many companies.
pharmaceutical research and development.
• Associated with Soneas from 1996.
• Msc. In Pharmaceutical Development
from Eötvös Loránd University.
• Head of Research and Development at Prochem Ltd, UNIDO Headquarters Vienna.
SANKETH VARALWAR SBU – Head (Specialty Chemicals) Director – Vivimed Labs Europe Ltd.
•
•
Seasoned Professional ,Over 2 decades of experience in Sales and Marketing in US/Europe.
B.E. degree in Computer Engineering.
• Assumed responsibility as SBU head in FY 15 and registered a phenomenal growth for the Spechem business.
page 9
Business Divisions…
API
Pharma
Generic
CDMO
Contract Manufacturing
FDF
Generic
JV (US)
Branded Business
page 10
Business Divisions
Global supplier of niche molecules and formulations (Pharmaceuticals) Integrated player – presence across critical components in value chain US FDA approved world class manufacturing facilities
Active Pharmaceutical Ingredient & CDMO UQUIFA s.a., Spanish subsidiary with 80 years of experience with USFDA approved
manufacturing units in Spain(2) and Mexico(1) manufactures API for Pharmaceuticals and animal health industry globally Accounts for 50% of the overall revenue
Finished Dosage Formulation Value added business delivering quality formulations and offering novel drug systems Present in generic, branded and contract manufacturing segments Accounts for 38% of the overall revenue
Product wise Sales Mix (%)
Specialty Chemicals , 12%
FDF, 38%
FY18
API, 50%
Specialty Chemicals (under divestment) Manufactures Hair Dyes, Photochromic Dyes, Anti-Microbials and Imaging Chemicals Vivimed is a world leader in the development of innovative photochromic dyes Vivimed has patented processes for novel dyes targeting a range of applications
FY18
page 11
Export, 88%Domestic, 12%Geography Mix (%) Sector Overview Pharmaceuticals
page 12
Pharmaceutical Industry – Overview (Global)
$ 1.4 Tn
Global spending on medicines by 2022 (expected)
$ 3.9 bn
Spending on branded medicine in developed market (past 5 years) as per IQVIA Institute
37%
Increase in patent expiry between 2018- 2022
$1415 - $1445 bn
Global medicine spending by 2022 (Forecasted)
Source: Industry Reports
Total Value $725 bn
Total Value $1,135 bn
Total Value $1415 – 45 bn
Source: Industry Reports
page 13
Pharmaceutical Industry – Developed Markets
$ 915-945 bn Pharmaceutical spending in developed markets by 2022
United States
7.3% CAGR 2013-17
4%-7% CAGR 2018-22
Europe
4.4% CAGR 2013-17
1-4% CAGR 2018-22
Source: Industry Reports
US pharmaceutical market is estimated to grow by 4-7%
CAGR from US$ 466.6 Billion in 2017 to US$ 585-615 Billion in 2022
Price increases and introduction of new specialty medicines
to drive the growth
CAGR for the next five years for EU5 markets is estimated at
1-4%, with overall spending in these markets likely to escalate from US$ 154.4 Billion in 2017 to US$ 170-200 Billion in 2022
Ageing population of countries and increased incidence of
chronic ailments to drive the growth
page 14
Pharmaceutical Industry – Pharmerging Markets
$ 345-375 bn Pharmaceutical spending in Pharmerging markets by 2022
Region / country
China
Tier 2 Markets
Brazil
India
Russia
Tier 3 markets
Total
2017
122.6
67.3
33.1
19.3
14.9
79.7
269.6
2013-17 CAGR
9.4%
11.2%
11.5%
11.0%
10.8%
8.9%
9.7%
2022
145-175
89-93
38-42
26-30
20-24
95-125
345-375
2018-22 CAGR
5-8%
7-10%
5-8%
9-12%
7-10%
6-9%
6-9%
Branded generic medicines comprise the largest proportion of medicine
spending in these economies
China, the largest pharmerging market, will grow at a modest 5-8% in the
next half decade, reaching US$ 145-175 Billion in 2022
India and Russia are expected to grow faster, in comparison, averaging at 10% in the same time span, while the other pharmerging markets will average 6-9%
India’s spending on medicines will propel its entry into the top 10 countries
in 2018, and to the ninth position overall between 2019 and 2022
9-7% CAGR 2013-17
6-9% CAGR 2018-22
Source: Industry Reports
(US$ per person/year)
page 15
API & CDMO Business (UQUIFA & SONEAS)
page 16
Global presence: a strategic advantage A global platform that combines quality with competitiveness
BUDAPEST, HUNGARY
BUDAPEST, HUNGARY
ST CELONI, SPAIN
ST. CELONI, SPAIN
LLIÇÀ DE VALL, SPAIN BARCELONA, SPAIN
GUANGZHOU, CHINA
HYDERABAD, INDIA
HYDERABAD, INDIA
SAN FRANCISCO, USA
CUERNAVACA, MEXICO
CUERNAVACA, MEXICO
Corporate office
Regulatory compliant intermediate manufacturing sites / pilot plant
R&D labs — international presence
Strategic cost advantage centres, formulation units and formulation labs for vendor development
CDMO Business Development Resource
page 17
Leveraging Global Presence
Global Platform provides Strategic advantage
UQUIFA operates across Spain, Mexico, Hungary, and India with a strong transnational management
team.
Global customer base with clients in more than 70 countries worldwide. Pharma Co has 42 distributor arrangements across 56 countries.
Trusted Franchise in its markets
Combination of quality manufacturing and track record of reliability with marquee clients. Switching sources of API supply is not easy due to evolving industry dynamics and importance of
compliance position
o These have become barriers of entry and are now benefiting experienced players like UQUIFA.
A strong “under-development” pipeline of new products. In terms of intellectual property, more than 150 active DMFs filed and 20 CoS approved. More than 75 years of experience in the pharmaceutical industry.
UQUIFA Group in Numbers
75%
25%
API % (Revenue share)
CDMO % (Revenue share)
70%
30%
Spain (Geography mix)
Mexico (Geography mix)
Acquired in 2011, UQUIFA is home to our API business comprising of generics & Contract development and manufacturing organisation (CDMO)
Rich Heritage – Serving leading pharmaceutical and animal health companies in Spain and Mexico for the last 8 decades
4 Multi-Product plants across continents
40+ # Type II Drug Master Files (DMFs) filed with USFDA
Strategically located Manufacturing Unit – Spain (2), Mexico (1)
Global Presence – Spanish facilities to meet / cater European Market; Mexican facility to supply to US market
150
# Active DMFs filed Worldwide
page 19
Timelines and key milestones Consistent record of reliability and adherence to quality standards
UQUIFA Incorporation
Takeover by HCH
Acquisition of the Mexican site
Acquired by Vivimed
Focus on growth
Soneas acquisition
1936
1991–92
1997–98
2011–12
2012–17
2017–18
• UQUIFA was founded as a manufacturers of opiates and FDF to pharmacies.
• UQUIFA became a leading supplier to Spanish pharmacies.
• Acquired by
Holliday Chemical Holdings, a UK based chemical company.
• UQUIFA acquired Barisintex with its headquarters and facilities in Sant Celoni, widening production capability
• UQUIFA acquired a new chemical plant in Mexico from SKB. This acquisition established the 3 manufacturing locations which UQUIFA operates today.
•
In 1998, Holliday Chemical Holdings was acquired by Yule Catto Plc.
• Acquired by
• UQUIFA is now
Vivimed Labs, a India based healthcare and specialty chemicals company.
•
Investments stepped up on manufacturing plants, product mix, and people.
focused on pursuing growth through a mix of CDMO and Generic API.
• Stronger client
mining, new product filings, compliance and operational excellence being focus areas.
• Raised capital from OrbiMed Asia, a healthcare focused PE firm.
• Soneas acquisition completed which brings phase 1–2 capability, new customer base, chemistry capabilities and greater coverage of the CDMO sector.
page 20
What is UQUIFA’s core positioning ? Originator and Generic customers require support for chemical intermediates and API production in both the development and commercial phases
Drug development
UQUIFA’s core positioning
Research phase
Development phases I, II and III
High-scale manufacturing for commercial phase
Marketing
Distribution and sales
Research requires highly skilled experts that supply research pipelines with novel and innovative molecules.
Development includes both synthetic, analytical, and regulatory/administrative services.
Production process requires both production capacity and industrial expertise.
Marketing has become increasingly important over the last several years as a means of differentiation and maximizing the revenue potential of a given therapeutic.
Distribution requires logistics and coverage networks. A robust sales force is also required to negotiate volume, discounts and promote products.
Drug manufacturing
UQUIFA’s core positioning
Building blocks
Intermediates
API
Formulation and production
Building blocks are the basic chemical ingredients involved in chemical / API synthesis.
Substances resulting from the conversion of reactants into a product and that are used for the proceeding steps in a chemical reaction.
Technical expertise in the development and manufacturing of a wide range of APIs
APIs are mixed with excipients based on a specific formulation for drug delivery.
Packaging
Drug packaging and distribution.
page 21
UQUIFA Group’s – Manufacturing Facilities
Lliçà de Vall Spain
Capacity
140, 000 L
Number of reactors Last
29 reactors
US FDA Inspection 8c-
September 2015 Yes
GMP Approval
June 2011 Yes Multipurpose
Korean
FDA Japanese
Mercaptan incinerator, biological effluent treatment
Sulphur chemistry, wiped film evaporation, hydrogenation, micronisation, sieving
Certification Pilot plant in
site
Residues treatment on-site
Technical expertise
St Celoni Spain
170, 000 L
29 reactors
May 2017
Yes
June 2011 Yes Multipurpose
Biological effluent treatment
Cuernavaca Mexico
180, 000 L
30 reactors
July 2018 Yes
June 2011 Yes Multipurpose
Biological effluent treatment off-site
Nitration, hydrogenation, in- situ prep, chlorination
Sulphur chemistry, roller compact unit, micronisation, sieving, lyophilisation
Budapest Hungary
208, 000 L
58 reactors
—
Yes
—
—
Multipurpose
Catalytic incinerator, off-site waste treatment
Optical resolutions, cryogenic and organometallic, high temperature, cyclopropanation, phosgenation (triphosgene), hydrogenations, halogenations, acid chloride preparations, carbene additions, diazotizations, Friedel-Crafts reactions, isomerizations, cyanations, carbonylation with CO
page 22
Regulatory expertise Highly trained regulatory experts at each site with experience in all major geographies
Filing Experience in all major geographies
o Over 50 Type II DMF’s filed with the FDA o More than 150 active DMF’s worldwide
Over 25 valid Certificates of Suitability
Many years of successful regulatory audits by different agencies
Registration Dossier: Capabilities UQUIFA developed registration dossiers with in-house APIs and is well versed with
EU filings and ANDAs for the USA
UQUIFA works with partners to develop the formulation, perform the bio- equivalency and files the dossier to obtain Marketing Authorizations
UQUIFA is willing to license either the dossier and/or the Marketing Authorization
Dossiers - Spain Omeprazole 20mg, 40mg caps Pantoprazole 20mg, 40mg FCT Duloxetine 30mg, 60mg caps Linezolid 600mg FCT
Linezolid 2mg/ml 300ml bags Erlotinib 100mg, 150mg tablets
page 23
Generics – Firepower in existing products
Products
Regulated Market volume (MT)
Growth rate in target markets (%)
UQUIFA’s Volume share (%)
Omeprazole
Quetiapine
Pantoprazol
Ranitidine
Doxylamine Succinate
Ciprofloxacine
Terbinafine
Etofenamate
310
215
260
660
21
680
75
30
5-6
6-9
10-12
1-2
5-6
1-3
4-5
3-5
20
5
10
25
35
6
2
60
Strategy
Establish cost advantage Increase capacity
Increase new filings Enhance sales outreach
Establish cost advantage Enhance sales outreach
Leverage on favourable market dynamics Drive sales by undertaking debottlenecking
Develop niche product Strengthen positioning
Leverage on favourable market dynamics Drive sales by undertaking debottlenecking
Improve cost position significantly Drive sales in growing markets
Develop niche product Drive sales by undertaking debottlenecking
• •
• •
• •
• •
• •
• •
• •
• • •
page 24
New generic pipeline Under development
Products
Apixaban
Bilastine
Brexpiprazole
Brivaracetam
Dabigatran
Edoxaban
Lesinurad
Mebendazole
Minocycline
Mirabegron
Pimavanaserin
Ricobendazole
Tapentadol
Tavoborole
Apixaban
Therapeutic Category
Anti thrombotic
Antihistamine
Anti psychotic
Anti epileptic
Anti thrombotic
Anti coagulant
Antigout
Anthelmintic
Antibiotic
Overactive bladder
Parkinsons treatment
Anthelmintic
Analgesic
Anti fungal
Anti thrombotic
Trademark
Eliquis
Bilaxten
Bilaxten
Briviact
Pradaxa
Savaysa USA, Lixiana in EU
Zurampic
Vermox
Minocin
Myrbetriq
Nuplazid
Albendazole sulfoxide
Nucynta
Kerydin
Eliquis
page 25
CDMO
page 26
Why UQUIFA for CDMO?
Protection
We protect your intellectual property
Quality
Expertise
Integration
Flexibility
Strong quality system approved by regulators and customers
Technical expertise in the development and manufacture of wide range of API’s
Flexible and adaptable to fulfil your needs
Backward integration ensures cost efficient operations and the location of our manufacturing base a source of risk mitigation.
page 27
CDMO platform Evolving constantly
Based in Barcelona, Spain, we are one of the first API/ advanced intermediates manufacturing companies offering R&D and cGMP manufacturing across three continents. Post Soneas acquisition, we also use manufacturing facilities in Budapest, Hungary.
Services include:
Development of novel synthetic routes and optimisation of
existing laboratory processes
Scale-up from Laboratory to Pilot Plant
Scale-up from Pilot Plant to commercial
Optimising laboratory developed routes of synthesis to reduce isolation steps, improve yield, reduce batch production time and eliminate the use of toxic and/or dangerous reagents
Transfer of commercial scale processes
page 28
Chemistry capabilities
Grignard reactions & Organometallic Chemistry
Fisher esterification & trans-esterification
Chiral Synthesis, Chiral resolution and Asymmetric Synthesis
Borane derivatives & coupling reactions
Heck reactions
Ozonolysis
Halogenations, Nitrations and Sulphur Chemistry
Hydrogenations (up to 5 bar) & reductions with reductive agents and different kind of hydrides
Triphosgene reactions (industrial precursor for phosgene)
Protection & de-protection Chemistry
Solid phase reactions
Crystallisation
PSD expertise
Polymorphism Studies
Pellets manufacturing capability in Spain
page 29
Development and scale up capability International R&D
Spain and Mexico R&D Lab
Spain and Mexico Pilot Plant
Custom synthesis, process improvement Capable of producing compounds from 1g to 1kg Small-scale glassware up to 20L glass reactors
Make processes scalable, safe and
environmentally friendly:
o Reduces isolation steps o Improves yield o Minimizes batch production time o Eliminates use of toxic and/or dangerous
reagents
Dedicated Analytical group for method development
HPLC, GC-MS, IR, UV, TGA, DSC, PSD (Malvern Mastersizer and Air-Jet)
Scale-up and small scale production
Producing 1kg to multi-kg quantities for Phase I, II
and III clinical trials and for small scale commercial production
Variety of vessel sizes and materials of
construction
Installations are flexible allowing many combinations of reactors, filters and dryers
Cryogenic capability Ozonolysis, hydrogenation and nitration
Qualified technicians run the plants under cGMP, on FDA approved sites
The quality control systems in the PP are identical
to those used for commercial production
page 30
CDMO case study
R&D product from US Biotech company
Therapeutic area: ARV compound, VIH
5 different FDF
5 reaction steps
Industrial challenge: nucleoside chemistry, hybride reaction
ENGINEERING AND
VALIDATION CAMPAIGN
PILOT PLANT
DEVELOPMENT
Commercial batches
PROCESS & ANALYTICAL
TECH TRANSFER
CUSTOMER AUDIT
AND APPROVAL
TECHNICAL PACKAGE
EVALUATION AND QUOTATION
CDA Signature
15 months
page 31
Soneas’ Offerings
Soneas Research
Product Development –
o Rapid development of APIs and their intermediaries o Custom contract manufacturing of cGMP APIs and
their intermediaries (laboratory to pilot plant scales)
Soneas Chemicals
Large Scale non-cGMP contract manufacturing –
o Rapid development of APIs and their
intermediaries
7
20
4.4m3
Laboratories
Chemists & Support
Reactor Capacity
200m3
Reactor Capacity
Soneas has advanced capabilities in new chemical entity (NCE) development as well as emerging technologies such as metal catalysis and heterocyclic chemistry. It also has capabilities for varied end usage, which includes neurology, dermatology, metathesis catalysts and synthetic hormones.
page 32
Soneas Facilities
Soneas Research
R&D laboratories:
Pilot Plant (7847 m2):
7 research labs 3 analytical labs NMR lab
1 kilo lab 1 analytical lab 1 IPC lab 2 process & scale-up labs 3 pilot plant production units
Soneas Chemicals
Large scale manufacturing site (63.000 m2):
2 production units Hydrogenation unit Distillation unit Drying and packaging unit
Reactor capacity – 208,000 L
page 33
CDMO – Value Proposition
Integrated solution provider following acquisition of Soneas
Protect clients’ intellectual property
Strong quality-control system approved by regulators and customers
Technical expertise in manufacturing a wide range of APIs benefits in the co- development of the CDMO products
Higher cost-efficiencies owing to backward integration in the business
page 34
Key Strategic Focus Areas
Expand therapeutic portfolio across anti- ulcers, Central Nervous System (CNS) and Cardio Vascular System (CVS) categories
Continue to grow the high-potential CDMO business
Achieve stronger client mining
Innovating on co-development options to build stable, profitable growth
Determine correct pricing to strengthen competitive positioning
Launch new products in generics business with focus on customer-driven projects
page 35
UQUIFA dynamics A summary of growth drivers in generics and CDMO
• Molecule portfolio with growing demand in areas such as anti- ulcer, CNS, and CVS • Operational and cost efficiency is improving market share Expansion in Japan,
Generics
•
•
Korea, and India
Competitive advantage of regulatory compliance
Pipeline of new products and improving market shares in Generic 50+ DMFs and 20+ approved CoS
CDMO
•
Industry with a 6–7% annual growth
• Operational and cost efficiency is expanding market share • Growth in EU, USA ,and Japan with Soneas technology •
Competitive regulatory advantage and compliance Increased
•
•
capacity — Phase 1/2, NCE (Soneas)
Full range "Lab — Pilot — Commercial Production"
page 36
Future growth drivers Looking forward
CMO API
•
•
Leveraging strengths of chemistry and manufacturing presence in the EU/NA.
Scale up of current relationship likely and leveraging of preferred supplier relationships with big pharma.
Soneas Platform
•
•
•
Opportunity to leverage UQUIFA large scale platform.
Access to new technologies and big pharma customer base in EU and Japan geographies.
Higher volume off-take for UQUIFA assured and better value retention for the Group.
Generic API
•
•
Growth from current products; more products per customer, more customers per product.
New products to secure future growth.
page 37
FDF
page 38
Finished Dosage Formulation
Value added business with focus on delivering quality and
novel drug formulation
Present in generic, branded and contract manufacturing
segments
Capacity – 2 bn solid oral dosages
Strategic tie-up with Strides Shasun to expand business in
US
Marquee clients – GSK, Dr. Reddy’s, Cipla, Merck Serono etc.
Focused on expanding into non – USA based regulated generic markets such as CIS and African countries
F D F
Contract Manufacturing (CM)
Generics
Branded Products
page 39
Facilities Overview
Jeedimetla Hyderabad PICs/NDA/WHO-GMP approvals
Kashipur, Uttarakhand ISO 9001-2000; ISO 4001 & OHSAS 18001 certifications
Klar-sehen, Hyderabad ISO 13485 certified
WHO-GMP/ NAFDAC approvals
CE certificate for medical devices
Haridwar Uttarakhand 2000, ISO 14001 and OHSAS 18001 certifications
ISO 13485 certified
Bolarum Hyderabad
Alathur, Tamil Nadu, (Now part of JV with Strides) USFDA Approved Facility
page 40
Key Strengths
4 commercial ANDAs today
Dedicated team of 60 scientists working on formulation developments for USA / Australia / EU and India market
Pan India presence in Institution Businesses like ESIC, Railways and many Central Government rate contracts
Registered and commercialized 4 products which includes Antiviral like Valaciclovir, Aciclovir, Pas Granules for supplies to the tuberculosis program in Russia
page 41
Partnering Innovation
page 42
Partnership with Innovator Companies
Working with innovator companies for the manufacture of products in the areas of Anti-retro viral, Urinary continence and Public acquired infections.
Experience of having worked with clients like Astellas, Leo, Eisai and greater engagements in Japan Markets after acquisition of Soneas.
UQUIFA and Soneas
Partnership with innovators at different phases of product development.
page 43
JV with Strides : Win - Win proposition
Entered into a 50:50 joint venture business with Strides to develop and commercialize various ANDAs in US
Mutual benefits - Vertical Integration of APIs & exploitation of mutual formulation capabilities
Looking to achieve 5 ANDAs per year from this JV in the complex generics space
Operations will be carried in the Solid Oral Dosage (SOD) facility, at Alathur, Tamil Nadu
page 44
Molecules commercialized under JV
Particulars
Amlodipine Besylate
Donepezil Hydrochloride
Losartan Potassium
Metronidazole
Brand name
Norvasc
Aricept
Cozaar/Hyzaar
Zolpidem Tartrate
Ambien
Sanofi
50
79
Flagyl
Pfizer
44
99
Innovator
Global sales ($ Mn)
# ANDA filers
First launched/ approved
Uses
Pfizer
312
373
1987
Eisai
200
91
1996
Merck & Co.
500
113
1995
• • •
Hypertension High blood Pressure Coronary artery Disease
•
Dementia of Alzheimer’s Disease
• •
Hypertension Lower blood pressure in adults
•
Bacterial vaginosis in non-pregnant Women
•
Insomnia characterized by Difficulties with sleep initiation
1963
1992
Recent Approvals:
- - - -
Ranitidine Azithromycin Nadolol Enalapril Maleate
ANDAs Awaiting Approval:
- - - -
Albendazole: CRL Responded Solifenacin Succinate: ANDA submitted Ibesartran: CBE filed (Awaiting launch) Acyclovir: CBE filed (Awaiting launch)
page 45
Delivering Affordable Chemistry
page 46
Delivering Affordable Chemistry
•We ensure all IPs are safe at all stages.
•Good R&D teams with highly accomplished professionals across all locations – Spain, Mexico, Hungary and India. •State-of-the- art R&D equipment. •Experience of working on development phases I, II and III, and scale up from lab to commercial scale.
•Manufacturing plants spread across Spain, Mexico and Hungary are all well recognized cost effective manufacturing hubs with demonstrated manufacturing capabilities.
•FDA approved plants in Spain (2) and Mexico (1). •cGMP approved R&D facilities in Soneas. •150+ active DMFs filed worldwide and 40+ type II DMFs filed with US FDA.
IP Protection
Right Chemistry
Cost Effective
Regulatory Compliances
•Technical expertise in the development and manufacture of wide range of API’s.
•Backward integration ensures cost efficient operations and the location of our manufacturing bases a source of risk mitigation.
•Flexible and adaptable to fulfil all the customer needs.
Expertise
Integration
Flexibility
page 47
Growth Levers
Launching formulations based on UQUIFA APIs in India and other
parts of the world
Developing innovative formulations across multiple delivery formats
for different parts of the world
Bolstering revenues and strengthening position in the formulations
business through JV with Strides Shasun
Strengthening filing pipeline of four to six new files every year
Ramping up the Contract Research and Manufacturing Services
(CRAMS) business
Achieving optimum utilization of existing capacities
page 48
Specialty Chemicals Business
page 49
Overview
Description
• Manufacturing active ingredients for home care, personal care and industrial products • Product range - hair dyes, photochromic dyes, photochromic products, anti-microbials and imaging chemicals • Maintains leadership position through captive manufacturing (Bidar-Karnataka) or with other partnerships • Current portfolio consists of 100+ products serving 300 + Customers with supply expertise for any volumes • Vivimed maintains world-class R&D capabilities with scientists who have a combined dye chemistry experience of greater than 100
years, both in Huddersfield-UK and Hyderabad-India.
Recognitions
• R&D certified as a GLP Laboratory by CISR - a government of India undertaking • Awards from Johnson & Johnson– Quality Promise to Zero Defect in 2010 and Implementation of Supplier Enabled Innovative Idea in 2005 • Certificate of Appreciation from Hindustan Unilever Limited in 2009 • Recipient of the Queens Award in 2008 • UK’s R&D team got the Centenary Medal by The Society of Dyers and Colorists (SDC) for Photochromic Dyes in 2005
Manufacturing Facilities
Manufacturing Facility – Bidar, India (Since 1991)
• Designed in compliance with US FDA norms & highest environmental standards • Environmental certification: ISO 9001: 2008 QMS and ISO 14001:2004; Safety Management system ISO 18001: 2007
Research & Development Facilities- Nacharam in India and Huddersfield in UK
• Focus on idea-generating research right from creation of molecule and collaborative manufacturing
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Top Customers
Hair Dyes
Photochromatic
COSMOTEC
page 51
Financial Overview
page 52
Financial Highlights – 9M & Q3 FY19
Revenues (Rs. cr)
907
984
EBITDA (Rs. cr)
185
173
PAT (Rs. cr)
67
58
9M FY18
9MFY19
9M FY18
9MFY19
9M FY18
9M FY19
303
250
52
43
21
11
9 1 Y F M 9
9 1 Y F 3 Q
Q3 FY18
Q3 FY19
Q3 FY18
Q3 FY19
Q3 FY18
Q3 FY19
page 53
Segmental Performance – 9M & Q3 FY19
Pharma Business
12.4%
9.9%
7.9%
9.6%
• Revenues grew by 12% y-o-y to reach Rs.
839 cr.
749
839
253
202
9M FY18
9M FY19
Q3 FY18
Q3 FY19
o Profitability
though
remained muted, with EBIT of Rs. 83 cr for 9M FY19
o Margins for 9M stood at 9.9% as
against 12.4% for 9M FY18
Specialty Chemicals Business
32.4%
30.5%
37.2%
151
129
46
• Revenue from the business stood at Rs. 129 cr for 9MFY2019 stood lower by ~15% compared to the same period last year.
o Profitability as well declined by 20% with EBIT of Rs. 39 cr for 9M FY19
20.2%
42
9M FY18
9M FY19
Q3 FY18
Q3 FY19
page 54
Debt Movement
901*
49
491
361
871 52
496
323
FCCB
Overseas Debt
Indian Debt
777
18-Mar
18-Sep
18-Dec
* September 2018 debt figure shown as Rs. 882 cr in last quarter’s Investor presentation was represented incorrectly and was actually Rs. 901 cr
Vivimed has been focussed towards debt reduction and reducing the cost of funds.
Figures in Rs. Crore, as per IndAS
page 55
Consolidated P&L Statement
Particulars
Revenue
Cost of Material Consumed
Employee Expenses
Other Expenses
EBITDA
EBITDA Margin
Other Income
Depreciation
EBIT
EBIT Margin
Interest / Finance Cost
PBT
Tax Expense
PAT
% Margin
Q3 FY19
Q3 FY18
Y-o-Y
9M FY19
9M FY18
Y-o-Y
Rs Crs.
243.9
89.3
42.3
75.6
36.7
15%
6.3
15.3
27.8
11%
17.6
10.2
-0.6
10.8
4%
299.6
128.2
52.3
70.2
48.9
16%
3.1
13.9
38.1
13%
17.2
20.9
-0.02
20.9
7%
-18.59%
-30.34%
-19.12%
7.69%
967.1
381.59
166.1
263.7
900.1
371.02
139.5
211.6
7.44%
2.85%
19.07%
24.62%
-24.95%
155.71
177.98
-12.51%
(100 bps)
103.23%
10.07%
-27.03%
200 bps
2.33%
-51.20%
-
-48.33%
-36.52%
16%
17.1
50.7
20%
6.7
42.6
122.1
142.1
13%
54.4
67.7
10.1
57.6
6%
16%
63.1
79
12.1
66.9
7%
(400 bps)
155.22%
19.01%
-14.07%
(300 bps)
-13.79%
-14.30%
-16.53%
-13.90%
-19.87%
# figures as per Ind AS
page 56
Profitability over Years
*Financial results are not strictly comparable with the results of FY 2017 as revenues from sale of divested business to Exeltis and Clariant India are included in FY 17.
Represents the normalised numbers for one- time gain from sale to Exeltis and Clariant India Ltd.
page 57
Thank You
Full Name
Sunil Arab
Sunil.Arab@vivimedlabs.com
Gavin Desa / Suraj Digawalekar
+022 6645 1237 / 19
gavin@cdr-india.com suraj@cdr-india.com
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