Fertility, Market size estimations

Report
Swedish - American Life Science Summit
Stockholm August 20, 2009
Magnus Nilsson, CEO
Agenda
•
•
•
•
Company background
Market presence and growth
Product/therapy areas
Outlook 2009
2
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.
Company Background
3
Our Vision
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.
4
Company Background
Vitrolife – Strategy
5
Company Background
A Process organisation to reflect the value chain
Order to Delivery
Purchasing
Production
QC
Sales
Order
Distribution
Product Life Cycle Management
Product idea valuation
Product development
Marketing
Supporting Processes
Quality Assurance
Company Background
Finance/Information
IT
Human Resources
Administration
6
Vitrolife – Reaching the global market
New offices in China
and Japan 2009
7
Market presence and growth
Sales by region rolling 12 months
8
Market presence and growth
Sales and growth rate 2009
9
Market presence and growth
Sales and growth rate 2009 - Fertility
Share of sales of Vitrolife
Growth rate for Vitrolife
Regional share of global cycles
~ 1.0 million cycles performed world wide per year
Market presence and growth
10
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 year
Market presence and growth
11
Key Financials: Investing in growth for the future
SEKm
200
180
160
140
14% of Sales invested in
R&D activities
120
100
80
60
40
20
20
05
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05
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20 2
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20 3
05
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06
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06
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20 2
06
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20 3
06
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20 4
07
Q
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07
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20 2
07
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07
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08
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08
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20 4
09
Q
20 1
09
Q
2
0
Gross Income
Operating Income before R&D
EBITDA
Operating Income
Income after financial items
12
Market presence and growth
Product areas - a genius combination
FERTILITY
STEM CELL CULTIVATION
TRANSPLANTATION
Customers/markets:
Customers/markets:
Customers/markets:
• Private and public clinics/
specialized laboratories
• Public specialized laboratories
/research institutions and private
companies
• ~ 400 institutions / 150
companies
• Public clinics
• ~ 3000 clinics
• Partly subsidized
• Subsidized & private
• ~ 1 million clin. IVF treatm.
• Research, in clinics 2-5 years
Product /Therapy areas
• ~ 200 Lung transpl clinics /
~ 2000 all transplantations
• Subsidized
• ~ 3000 Lungs/ ~ 50000 all
transplantations
13
Fertility – Competitive advantage
FERTILITY
• 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
Product /Therapy areas
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
14
History of Innovations
FERTILITY
New technique follicle aspiration
needle with
ultrasound probe
1983
ICSI Medium
1994
Pharmaceutical
-grade media
IVF™-50
First
sequential
media G1™/
G2™ v. 2
1995
1998
Beyond HSA –
Recombinant
media
r-S1™/ r-S2™
2001
Closer to Nature
GIII Series™ v.3
2002
Breakthrough Innovations
EmbryoGlue®
Implantation
promoting medium
2003
Unique aspiration
needle –
SWEMED ™
Sense
Acquisition of
SWEMED lab
GIII Series ™
CE marked
2004
Product /Therapy areas
Ultrarapid
vitrification
2005
2006
2007
2008
15
Product portfolio development
FERTILITY
Strategy: Portfolio expansion through R&D and
acquisitions to optimize market synergies:
Target: Increase product offering value per
cycle with 50%
Product /Therapy areas
16
Stem Cell cultivation
STEM 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
17
Product /Therapy areas
Giant market expectations in cell therapy
STEM CELL CULTIVATION
Market Size
2007
Market Size
2012
Market Size
2017
Time 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
Technology
Source: Jain Pharmatech
18
Product /Therapy areas
Cell Therapy – Situation analysis
STEM CELL CULTIVATION
• 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
19
Product /Therapy areas
Stem cell culture media – Regulatory
STEM CELL CULTIVATION
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
20
Product /Therapy areas
Stem Cell Cultivation – Focus areas
STEM CELL CULTIVATION
• 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
21
Product /Therapy areas
Transplantation – the new way
TRANSPLANTATION
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
22
Product /Therapy areas
STEEN Solution™ - Focus Area
TRANSPLANTATION
• 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 lungassessment with Steen Solution ™.
23
Product /Therapy areas
Vitrolife – STEEN SolutionTM
TRANSPLANTATION
Problem
STEEN Solution™
• >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)
Advantage

• More organs can be
used

• More organs
available for
transplantation
• Maximum time >24
hours outside the
body

• More organs can be
used in time (lower
cost)
• More patients can be
provided with new
lungs

• Fewer deaths caused
by lack of organs
24
Product /Therapy areas
Vitrolife – STEEN SolutionTM
TRANSPLANTATION
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.
25
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
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Support launch of STEEN Solution™ in Europe
and prepare for market introduction in USA and
Canada
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Strong R&D focus with gradually increasing
efforts in Transplantation and Stem Cell
Cultivation
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Maintain profitable growth and operational
strong cash flow
Outlook 2009
26
With sustainable profit & cash flow…
…reaching
the global market
…investing
in growth
…for
the future

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