e test presentation

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


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





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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





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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


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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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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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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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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 ……………..

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