Marketing StrategyPrimary Arguments
Considerationsfor positioning and selling Etest®
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Background
Company background AB BIODISK: Founded in Stockholm, Sweden in the 1960’s Mission statement: “To Promote the Rational use of Antibiotics.” Internationally recognized for its antimicrobial resistance testing range and expertise in susceptibility testing of
fastidious and unusual organisms 7.5 million test sold in >70 countries Acquired by bioMérieux on June 18, 2008 because of the excellent synergies between the two companies
Company background bioMérieux: Mission statement: “To contribute to the improvement of worldwide public health through in vitro
diagnostics. “
A world leader in the field of in vitro diagnostics for 45 years, bioMérieux, with over € 1.06 bil in revenue, is present in more than 150 countries through 38 subsidiaries and a large network of distributors.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and/or contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMérieux is listed on the NYSE Euronext Paris market (Code: BIM – Code ISIN: FR0010096479).
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Agenda
1. Etest Products and Technology
2. Etest and Biotools in the Laboratory
3. Application Areas
4. Positioning and Sales
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Product Portfolio
The Etest product line
- Main product line
- 57 IVD products (drugs) cleared by the FDA
- 38 products (drugs) available in ROW, as RUO in the US
- Products available for AST, AFST, AMST, ARD
- Sold in packages of 100 (95%) and 30 strips (5%)
The Biotools product line- Supporting product line for Etest - Designed to simplify the use of Etest
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Etest Product Line
Antimicrobial susceptibility testing- 57 agents available (IVD, USA and WW)- 38 agents available (IVD WW, RUO USA)
Antifungal susceptibility testing- Fluconazole, Flucytosine, Itraconazole (IVD USA and WW)- Amphotericin B, Anidulafungin, Caspofungin, Ketoconazole, Posaconazole, Voriconazole (IVD WW,
RUO USA)
Antimycobacterial susceptibility testing- Ethambutol, Ethionamide, Isoniazide (RUO USA)
Resistance Detection tests- 3 ESBL strips (2 IVD/1 RUO USA) for confirmation of extended spectrum beta-lactamase- 1 MBL strip (RUO USA) for detection of metallo-beta-lactamase- 1 GRD strip for glycopeptide resistance detection (RUO) - 1 strip for AmpC detection (RUO)
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Etest Gradient Technology
PREFORMED and STABLE gradient
ON-SCALE MICs
WIDE CONCENTRATION RANGE (15 dilutions)
FLEXIBLE test method/ inoculum tolerant
VARIETY of agents
AGAR based system
RESISTANCE DETECTION - low level, inducable and hetero resistance
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Etest stable gradientscompetition with Disc Diffusion
Disc diffusion changing gradient
Etest stable gradient
Etest optimal for fastidiousand slow-growing organisms
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On-scale MICs
• Confirm unusual, equivocal AST results in the laboratory, especially when MICs cluster around breakpoints
• Validate empiric regimen - surveillance testing• Target individual therapy using MIC & PK-PD• Dosage adjustment, especially in
immunocompromised patients• Monitor resistance, de-escalate, modify, or change
therapy especially in poor response to therapy or recurrent infections
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Optimal for resistance detection
P. aeruginosa Broth dil 0.06 Agar dil 0.125 Etest MIC >32
• Hetero - resistant subpopulations• Inducible - resistance phenotypes• Hyper-mutators (Oliver A. et al. AAC, 2004)
• Stepwise - mutators• Small Colony Variants• etc................
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Etest for Therapy Optimization
MIC 64 4 1 0.125 4
Drug C best alternative
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Novel MIC technology
High level of innovation
Proprietary
Globally standardised
Branding - strong global trademark
Premium pricing - ”theranostics concept”
Etest - a Global Brand in Microbiology
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Agenda
1. Products and Technology
2. Etest and Biotools in the Laboratory
3. Customers and Application Areas
4. Positioning and Sales Tactics
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Transport and Storage
Package 100 or 30 strips/pack Sold in foam and blister package (NOTE: not all products available in foam
package)
Transport Ambient temp (20 - 35°C) / courier / 5 days Lead time 30 days
Storage Should be stored at temperature conditions specified on the package
• - 20°C (blister package)
• + 4-8°C, or +18-22°C (foam package) depending on agent. Can store all agents in foam package at +4-8°C
• Etest has 1 to 5 years shelf life from date of manufacture
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Storage Systems
Open packages should be stored in a stable and airtight storage with desiccant
Etest storage accessories available in different sizes for storage of 1 up to 12 agents
Storage container(1 cartridge)
MINI (2 cartridges)
MIDI (6 cartridges)
MAXI (12 cartridges)
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Susceptibility Testing Media
Aerobes: Mueller Hinton agar
MRSA/MRSE: Mueller Hinton + 2% NaCl
Pneumo/Strep: Mueller Hinton + 5% blood
H. influenzae: HTM, Mueller Hinton chocolate
Anaerobes: Brucella blood agar
VRE/VRS: Brain Heart Infusion
Yeast: RPMI 1640 + 2% glucose + MOPS
Others - see specific Etest Application Sheet
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Set-up and Incubation
3. Incubate
Aerobes:Anaerobes:Gram neg NF:Yeast:MRSA/MRSE:VRE/VRS:Enterococci:Pneumococci:Streptococci: Neisseria: Haemophilus:
ambient, 15-18 hanaerobic, 24-72 hambient, 24 h/48 hambient, 24h/48hambient, 24/48 hambient, 24/48 h ambient, 24 h
5% CO2, 20-24 h
5% CO2, 20-24 h
5% CO2, 20-24 h
5% CO2, 20-24 h
Incubation at 35°C
1. Inoculate
Retro C80 Inoculator- Ergonomic- Even inoculum- For Etest and KB
2. Apply the strips
Methods- Simplex C76 dispenser system- Nema C88 vacuum pen- Forceps
Application templates- 3-6 strips per 150 mm plate- 1-2 strips per 90 mm plate
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Biotools Application Systems
Simplex C76 automatic strip applicator - Flexible MIC antibiograms - Optimal positioning - Easy and Fast
Nema C88 manual strip applicator - Vacuum pen - Finger tip control
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Agenda
1. Products and Technology
2. Etest and Biotools in the Laboratory
3. Customers and Application Areas
4. Positioning and Sales Tactics
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Sales Mix by Etest Product
Top 5 products (104 total): 36% of salesTop 10 products: 56% of salesTop 15 products: 66% of sales
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Etest Scientific Focus
• > 3,000 scientific references – 50 countries• 2.9 M isolates > 15 million data points• Current emphasis on clinical needs for MIC• Top applications - % studies:
- S. pneumoniae/Strep 20%
- Critical specimens/MIC 18%
- Resistance detection 15%
- Antifungals 15%
- Surveillances 10%
- Anaerobes 10%
- GNF & MDR 10%
- Other 2%
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Agenda
1. Products and Technology
2. Etest and Biotools in the Laboratory
3. Customers and Application Areas
4. Positioning and Sales Tactics
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Positioning of Etest
Value Proposition
Etest is an easy-to-use complement to existing AST systems that provides an extensive range of antimicrobials and MIC values needed for therapeutic decisions.
Positioning
Etest strips will compliment the antibiotic test menu in routine clinical laboratories.
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Positioning of VITEK 2 and Etest
VITEK 2 and Etest technologies are very complimentary
VITEK 2 automation provides same-day, clinically relevant identification and susceptibility testing for the majority (~ 90%) of organisms encountered in the routine clinical laboratory
Etest provides MICs for slow-growing and fastidious organisms that have unique growth requirements and cannot be tested by automated methods
Etest can be used as a simple confirmation test for equivocal results
Etest enables flexibility in testing new antimicrobial agents due to rapid development cycle
Less likely to require redevelopment due to breakpoints change
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View this as a “Synergy” package solution
Organism groups not available for testing on routine system
• Anaerobe testing
• Antifungal testing: yeasts and moulds
• Mycobacterium testing including M. tuberculosis
• Neisseria / Haemophilus testing
• Streptococcus viridans and Group A Streptococcus testing
• Fastidious Gram negative: Francisella, HACEK, Legionella, Bordetella, Bartonella, Campylobacter,…
• Fastidious Gram positive: Nocardia, Rothia, Gemella, ….
• Helicobacter pylori
Positioning of VITEK 2 and Etest
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Positioning of VITEK 2 and Etest
VITEK 2 and Etest technologies are very complimentary
However, they are 2 different devices that are used for the same purpose
Therefore, occasionally there will be differences in final results
Obviously, .... we will have to address these questions from our customers
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Positioning of VITEK 2 and Etest
AST methods are all developed to give results equivalent to a reference method; there are 2 MIC reference methods:
Broth dilution Agar dilution
VITEK 2 and Etest were originally developed to agar dilution We are now developing VITEK 2 to broth dilution (new antibiotics or
redeveloped antibiotics) We are also validating and developing Etest to broth dilution
Why? Broth dilution is now more widely accepted as the reference method
(EUCAST, CLSI)
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Positioning of VITEK 2 and Etest
Remember that there are other differences Etest
Agar-based method Overnight incubation Manual read MIC values read on continuous gradient
VITEK 2 Broth-based method Rapid method Automated read MICs reported based on standard two-fold dilution series
Both methods can be affected by drug, bug, incubation time, incubation atmosphere, MIC of the drug (does the MIC fall at or around the breakpoint for example?), growth medium used, type of resistance, other factors, ………
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Positioning of VITEK 2 and Etest
So which system is correct when there could be as much as a 2 dilution difference between the results?
They both could be “right”. This is the nature of a biologic system, there is NO absolute right or wrong!
You have to consider all of the previously mentioned factors
Resolution may require performing a reference method
Even reference methods don’t always agree with each other! Bugs can behave differently when tested differently (as previously mentioned). Usually the category (S, I, R) will be the same UNLESS the MIC is around the breakpoint, then the
variation will be between S and I or R.
“Generally the acceptable reproducibility of the test is within 1, 2-fold dilution of the actual endpoint.”
CLSI M7-A7, page 3, 2006
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Antifungal testing (AFST)
Now accounts for 10 to > 20% of total purchases in many markets
Global sales 7% (0.5 million strips)
US sales 2% - late start, enormous potential left
European sales 5 – 25%
Clinical recognition for the need for AFST increasing
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Supplemental Yeast Etest panel
CS
MYC
IT
POS
AND
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Think Patients, Diseases, Resistance….
Immunosuppression Chronic infections (e.g. cystic fibrosis) VAP – important, high mortality niche ICU – suboptimal antibiotic practices today Sepsis (bacteraemia, candidemia), meningitis, endocarditis,VAP,
etc
Cost not an issue, patient costs extremely high, infection control crucial 50% of therapy in critical care are antibiotic combinations Organisms - GNF (MDR), MRSA, VRE Estimation = 5 cases/d x 4 strips each = 20 strips x 300 working days = 6,000
strips/ year
Critical Care
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Cystic Fibrosis patient populationse.g Emory University Hospital, Atlanta USA
Prior usage: 1,000 strips/yr.
After CF conversion: 10,000 strips/yr
CF Potential in your market?- CF patients seen/yr = 500 (could be the same)
- AST spec/month = 50 (approx 10-15/wk)
- 4 strains/morphotypes/spec x 6 strips x 50 spec x 12 mo = 14,000/yr
- Potential Etest volume low: 5000, medium: 10000, high: 20000 strips/centre
- Times the number of centres
Critical Care Cystic fibrosis
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Paediatric
Thus far neglected segment….
Different PK/PD considerations, dosages etc.
Example of leading US Children’s Center Children’s Hospital of Philadelphia (CHOP)
• 18,000 strips/ year
Potential in your market?
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Fastidious and Orphan organisms
CLSI M45-A describes AST of orphan organisms
Market growth in HI & GC & Meningococci segments are good indicators
Developed algorithms show ”Orphans” e.g. HACEK
Rapid Growing Mycobacteria (RGM) opportunity
Essentially all organisms without breakpoints
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The in vitro diagnostics market
An steadily growing market
Growing healthcare needsAging population Sicker patients
Need to lower healthcare costs Need for better clinical decisions ……………………………………………….
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bioMérieux
A major player in the in vitro diagnostics market
A broad international presence
Strong positions in high-growth segments (e.g. ID/AST >47%)
Sales network: high quality, knowledgeable, global coverage
R&D: substantial investment over the long term
Industrial applications, global leadership
Only company in the industry with extensive skills in culture, molecular biology and immunoassays
Installed base of more than 16,000 ID/AST instruments
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Strategic plan
From a strategy focused on the laboratory
Infectious diseases, oncology, and cardiology Industrial applications
To a strategy focused on patients, consumers, pathologies and clinicians' needs
Infectious agents: clinical and industrial applications Tests delivering high medical value
• Theranostics: therapeutics + diagnostics• Oncology• Cardiology• Point-of-care tests• etc…….
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bioMérieux Microbial Infections
Become the undisputed leader in Microbiology
ID/AST Objectives (from LRP) Annual growth rate of +8% (auto), +4% (manual) Market share of approximately 55% in 5 years (from 47% in 2007)
Assets More than 40 years of experience and know-how More than 50% of the market in automated culture
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INDUSTRY
Objective 2012: market share of approx. 30%
Organic growth - R&D PPM: growth driven by chromogenic culture media TEMPO: US launch in Q1 2007 and menu extension Molecular biology: first test for industry to be launched in 2007
External growth Distribution agreements: e.g. exclusive worldwide distribution with Copan Acquisitions
Assets Undisputed leadership Ability to leverage the clinical sales network
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Etest and VITEK 2Synergy through marketing
Established global marketing and sales channel can immediately increase the volume of Etest sales
Product synergies gives cost effective marketing, think ”bundling”
Automation + Manual synergy gives competitive advantage against other automated systems
Agar based + broth based MICs give a competitive AST package
R&D and new product development synergies
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Etest and VITEK 2AST Testing Synergy
Etest is a very strong, internationally recognized brand
Supported by more than 3,000 scientific references
Optimal method for fastidious and unusual organism
15 dilution MIC concentration for all products
Complimentary to the VITEK technology
Very positive sales trends
2 products with a very solid track record More than 40 years of experience in infectious diseases Demonstrated innovation capabilities Deeply committed teams ……………..