Swedish - American Life Science Summit Stockholm August 20, 2009 Magnus Nilsson, CEO
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Transcript of Swedish - American Life Science Summit Stockholm August 20, 2009 Magnus Nilsson, CEO
Swedish - American Life Science Summit Stockholm August 20, 2009
Magnus Nilsson, CEO
Agenda
• Company background• Market presence and growth• Product/therapy areas• Outlook 2009
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Vitrolife – a global life science company
• A global life science company (Bio-Med Tech). Main sites in Gothenburg and Denver, Colorado
• Developing, manufacturing and selling nutrient solutions (media) and instruments for fertility treatments and lung transplantations.
• Growing and profitable business founded in 1994.
• Approx 160 employees.
• Sales in more than 85 countries. Local presence Nordic countries, US, Canada, Italy, Benelux, Austria, Germany, China, Japan, Australia, France
• Listed on the OMX Nordic Exchange’s Nordic Small Cap list since 2001. 3
Company Background
Vitrolife strives to be the leading supplier of media and other advanced disposables, used by hospitals and laboratories performing fertility treatment and other therapies where cells or tissues are used or are a part of the therapy.
Our Vision
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Company Background
Vitrolife – Strategy
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Company Background
A Process organisation to reflect the value chain
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Order to Delivery
Company Background
Purchasing Production QC Sales Order Distribution
Product Life Cycle Management
Product idea valuation Product development Marketing
Supporting ProcessesQuality Assurance Finance/Information IT Human Resources Administration
Vitrolife – Reaching the global market
New offices in China and Japan 2009
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Market presence and growth
Sales by region rolling 12 months
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Market presence and growth
Sales and growth rate 2009
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Market presence and growth
Sales and growth rate 2009 - Fertility
10~ 1.0 million cycles performed world wide per year
Market presence and growth
Regional share of global cycles
Growth rate for VitrolifeGrowth rate for Vitrolife
Share of sales of Vitrolife
Highlights of 2009• Sales first half year +23%
• Increased investment in R&D and marketing
• Fertility: Strong development in Asia, Europe and Middle East
• Transplantation: Positive progress for the clinical study in Canada for STEEN Solution™
• Successfull start up of the new offices in Asia
• Dividend 0.40 SEK/share paid out
• EBITDA 28,4% of sales
• Operating margin 14,4%
24 quarters of continuous operating profits
26 quarters in a row with better sales than previous year11
Market presence and growth
Key Financials: Investing in growth for the future
SEKm
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2005 Q
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2007 Q
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2008 Q
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Gross Income Operating Income before R&D EBITDA Operating Income Income after financial items
Investing in growth
Investing in growth14% of Sales invested in 14% of Sales invested in
R&D activitiesR&D activities
Market presence and growth
Product areas - a genius combination
Customers/markets:
• Private and public clinics/ specialized laboratories
• ~ 3000 clinics
• Partly subsidized
• ~ 1 million clin. IVF treatm.
Customers/markets:
• Public specialized laboratories /research institutions and private companies
• ~ 400 institutions / 150 companies
• Subsidized & private
• Research, in clinics 2-5 years
Customers/markets:
• Public clinics
• ~ 200 Lung transpl clinics / ~ 2000 all transplantations
• Subsidized
• ~ 3000 Lungs/ ~ 50000 all transplantations
FERTILITY TRANSPLANTATIONSTEM CELL CULTIVATION
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Product /Therapy areas
Fertility – Competitive advantage
New unique needle for the collection of human oocytes, Swemed Sense™, recently launched and approved for
sales in Europe– Potential market estimated to EUR 50 million
• A complete range of advanced clinical products
• Regulatory approval– CE mark– FDA 510(k)
• State of the art production facilities
• Industry leading QC
• Global market reach
• External collaboration with the leading scientist
FERTILITY
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Product /Therapy areas
ICSI Medium
Pharmaceutical-grade media
IVF™-50
First sequential
media G1™/ G2™ v. 2
Beyond HSA –Recombinant
media r-S1™/ r-S2™
Closer to NatureGIII Series™ v.3
EmbryoGlue®Implantation
promoting medium
1994 1995 1998 2001 2002
2003 2004 2005 2006 2007 2008
GIII Series ™ CE marked
Acquisition of SWEMED lab
Ultrarapid vitrification
Unique aspiration needle –
SWEMED ™ Sense
New technique -follicle aspiration
needle with ultrasound probe
1983
History of Innovations
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FERTILITY
Breakthrough InnovationsBreakthrough Innovations
Product /Therapy areas
Product portfolio development
Strategy: Portfolio expansion through R&D and acquisitions to optimize market synergies:
FERTILITY
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Target: Increase product offering value per cycle with 50%
Product /Therapy areas
STEM CELL CULTIVATIONStem Cell cultivation
• Products for human embryo stem cells and cryo preservation of stem cells
• State of the art production facilities
• Industry leading QC
• Cooperation with leading scientist
In VitroHes researchers can successfully grow human stem cells and maintain pluri potency
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Product /Therapy areas
STEM CELL CULTIVATIONGiant market expectations in cell therapy
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TechnologyMarket Size
2007Market Size
2012Market Size
2017Time increase 2007 to 2017
Stem cell transplant $2.4 billion $5.3 billion $11.3 billion 4.7x
Supporting technologies: cell lines, cell culture, delivery devices $2.6 billion $5.9 billion $10.2 billion 4x
Cell-based gene therapy $1.7 billion $3.2 billion $6.0 billion 3.5x
Cord blood collection therapy $0.7 billion $1.1 billion $2.5 billion 3.6x
Product /Therapy areas
Source: Jain Pharmatech
STEM CELL CULTIVATIONCell Therapy – Situation analysis
• Clinical applications for MSC, HSC, CBSC, FNSC
• >3 years before therapies based on hESC reach clinic due to:
– Difficulties to control differentiation– Scaling up production– Ethically controversial– Regulatory authorities
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Product /Therapy areas
STEM CELL CULTIVATIONStem cell culture media – Regulatory
Harmonisation of regulatory requirements and a long term view is a need for a safe treatment
• US– Regulated by FDA/ CBER– Classified as Class 1 Medical
Device, exempted from 510(k)
• EU– Classified as non Medical Device– To be produced according to GMP
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Product /Therapy areas
STEM CELL CULTIVATIONStem Cell Cultivation – Focus areas
• Increase focus on development of new ”clinical grade” stem cell media together with our partners.
• Fulfill the clinical requirements as set out in other areas
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Product /Therapy areas
Transplantation – the new wayTRANSPLANTATION
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The new method radically increases the availability of organs for transplantation
• Pioneering lung perfusion system (ex vivo and at 37ºC)
– Clinical trial in North America of Steen Solution™
– Innovative equipment for organ evaluation ex vivo
• Development of perfusion systems for other organs
– Preclinical trials with other organs e.g. liver, heart
Product /Therapy areas
STEEN Solution™ - Focus Area
• Finish clinical studies in North America and apply for marketing authorization for Steen Solution™ in the U.S. Clinical results so far very promising.
• 25 lungtransplantations performed in clinic so far
• Continue launch of STEEN Solution™ in Europe by training and education in the STEEN Solution™ method to get market acceptance
• Developing of and clinical trials with additional products needed for a lung-assessment with Steen Solution ™.
TRANSPLANTATION
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Product /Therapy areas
Vitrolife – STEEN SolutionTM
• >70% of donated organs are not used
• Too few organs to transplant
• Short of time, a maximum of 8-12 hours outside the body
• Patients die while waiting for organs
• Functional testing
• Large number of potential donors
(including donation after cardiac death)
• Maximum time >24 hours outside the body
• More patients can be provided with new
lungs
Problem
• More organs can be used
• More organs available for
transplantation
• More organs can be used in time (lower
cost)
• Fewer deaths caused by lack of organs
STEEN Solution™ Advantage
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TRANSPLANTATION
Product /Therapy areas
Vitrolife – STEEN SolutionTM
Before STEEN Sol.
Costs for products per evaluation (SEK) ca 10.000 > 30.000
Potential number of transplantations ca 3.000 > 20.000
Market potential*, lungs only (SEK million) ca 35 > 600
* Including research market
Approved in Europe 2006, and in Australia 2008.The method is also being developed for other organs, e.g. liver.
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TRANSPLANTATION
Product /Therapy areas
Outlook 2009• Continued execution of main strategy:
– Establish direct sales on all major markets covering 80% of all treatments
– Exploit market synergies with broader product portfolio through development and/or acquisitions
– Increase gross margin through continuous improvement of operations
• One major new product launch in Product Area Fertility
• Support launch of STEEN Solution™ in Europe and prepare for market introduction in USA and Canada
• Strong R&D focus with gradually increasing efforts in Transplantation and Stem Cell Cultivation
• Maintain profitable growth and operational strong cash flow 26
Outlook 2009
…investing in growth
With sustainable profit & cash flow…
…reaching the global market
…for the future