Attached files
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| 8-K - FORM 8-K - ORTHOVITA INC | d8k.htm |
 2011
Corporate Presentation
: VITA
Exhibit 99.1 |
 2
This presentation contains forward-looking statements by Orthovita regarding our
current expectations of future events that involve risks and uncertainties,
including without limitation, our VITOSS
™
, VITAGEL
™
, VITASURE
™
and CORTOSS
™
products and other aspects of our business.
Such statements are based on our current expectations and are subject to a number of
substantial risks and uncertainties that could cause actual results or
timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference include, but are not
limited to, our dependence on the commercial success of our approved products, the need
to maintain regulatory approvals to sell our products, our ability to manage commercial
scale manufacturing capability and capacity, our success in expanding our
commercial product portfolio and distribution channel,
competition and other risk factors listed from time to time in reports filed by
Orthovita
with
the
Securities
and
Exchange
Commission,
including
but
not
limited
to
risks
described
in
our
most
recently
filed
Form
10-K
under
the
caption
“Risk
Factors.”
Further
information
about
these
and
other
relevant
risks
and
uncertainties
may
be
found
in
Orthovita’s
filings
with
the
Commission, all of which are available from the Commission as well as from Orthovita
upon request. Orthovita undertakes no obligation to publicly update any
forward-looking statements. Safe Harbor Statement
|
 Positioned to be a leading provider of novel,
well researched Orthobiologics
and Biosurgery
technologies for patients, surgeons and hospitals.
Positioned to be a leading provider of novel,
well researched Orthobiologics
and Biosurgery
technologies for patients, surgeons and hospitals. |
 Key
Investment Considerations Strong Market Shares in Orthobiologics
and Biosurgery
Market
leader
in
synthetic
bone
graft
substitute
market
with
33%
share
Solid #3 position in hemostasis
biosurgery
market with opportunity to grow
Products differentiated by extensive research and data with clinical value
propositions based on solid evidence-based medicine
Fully integrated operation for developing and manufacturing proprietary
biomaterials Commercial Capability
The
only
direct
sales
force
solely
focused
on
orthobiologics
and
biosurgery
80 to 85 direct sales representatives augmented by agents and distributors in
U.S.
10 direct sales representatives in U.K.; distributors in other OUS markets
Growth Opportunities
Aggressive product lifecycle management
Opportunities to expand product usage outside of traditional spine market
OUS expansion efforts
Direct selling organizations in select countries/expand distribution to new
countries
Active new product pipeline development program
Incorporate current proprietary technologies into new product categories
|
 5 |
 US Bone Grafting
Market 2010 - 1.7 MM Procedures
*Millennium Research Group: US Markets for Orthopedic Biomaterials 2010
DBM
BMPs
Other Synthetics
Stem Cells
Autograft
Allograft Chips |
 7
US
Synthetic
Bone
Graft
Substitute
Market
2010
–
~$150mm
ApaTech
Medtronic Spine
*Millennium Research Group: Leading Competitors in the Global Synthetic
BGS Market 2010
Mastergraft
33%
16%
13%
35%
Synthes
10%
All Other
Synthetic BGSs |
 8
Vitoss
Bone
Graft
Substitute
–
Value
Proposition
Eliminates risks associated with autograft, allograft and BMPs
Provides
all
three
key
components
for
bone
regeneration
*
:
Scaffold
–
Cells
-
Signals
Broadest product range in category
Equivalent
efficacy
to
autograft,
the
gold
standard
*
Multiple new product opportunities to speed bone
regeneration vs
standard Vitoss
*
When used as directed with BMA |
 9
The most pre-clinical and clinical research of any product in its class
Vitoss Comparative Effectiveness |
 10
Vitoss Franchise Market Leadership
Early
Market
Entry
–
January
2002
Over 300,000 implantations
Most extensive bibliography in
its class
Covers majority of non-
structural bone grafting
indications
20 studies in spine with 800
patients
Extend Reach into BMP Market
Demonstrated effectiveness
with lower procedural cost
Vitoss BA2X enhances
conversion rationale
Leader in technology innovation |
 Fusion Product Pipeline
Vitoss
BA2X
BMA Concentration**
Vitoss
BA Bimodal**
Vitoss
Platform
Development
Preclinical
Clinical
Regulatory
Bioactive Inter-body device**
BA PEEK –
New Platform
Preclinical
Clinical
Regulatory
$1.6B Bone Graft Market
$2.5B Inter-body Fusion Market ~$1B PEEK
FDA Cleared; Expected
Q1/11 Launch
In FDA discussion
File 510(k) Q1/11*
Development
*Obtain clarity on regulatory pathway, IDE requirement
**Device has not received regulatory clearance or approval
|
 Vitoss
BA Bimodal
More Bioactivity
–
After immersion in simulated
body fluid for 7 days, shows
greater surface area coverage
of calcium phosphate*.
*
Calcium phosphate coverage (bioactivity) is
indicative of ability for in
vivo bone
bonding
More Ion Release
–
Dissolution studies
show faster release of
sodium and silicon
ions after 21 days
exposure to
physiologic conditions.
BA Foam
Bimodal |
 Bioactive PEEK
(Cervical Interbody Fusion Device in
development phase) |
 Pre-clinical In vivo Study-Bone Bonding at 6 months
BA PEEK w/ BA Foam
Zoom section
T |
 Vitoss
Strategy
Position Vitoss
BA and BA2X as premium products with strong
value proposition compared to BMP
Aggressively price Vitoss
classic and morsel products to better
access price-sensitive end of market
Develop Vitoss
Bone Graft Systems Approach
Broaden portfolio of bone graft products to address hospitals’
desire for fewer vendors
Expand sales reach outside of spine
Revision total joints
Extremities, especially foot and ankle
Trauma and tumor |
 16 |
 17
Floseal
®
Tisseel
®
Coseal
®
Surgiflo™
Evicel™
Bioglue
®
Hemostase™
Orthovita Hemostat Market 2008 –
$500 Million
*2008,
Millennium
Research
Group
“US
Market
for
Surgical
Hemostats,
Internal
Tissue
Sealants
and
Adhesion
Barriers,
2008";
Cryolife
2008 Year End
Earnings.
Orthovita has distribution rights for Vitasure
in spine and orthopedic applications.
Baxter
Cryolife
Ethicon
Platelet Gels |
 Controls Bleeding, Facilitates Healing:
Only
hemostat
with
the
combination
of
microfibrillar
collagen,
thrombin
and
the
patient’s
own
plasma;
supports
hemostasis
and
fibroblast attachment
Knee
Arthroplasty
Research:
Less drainage, reduced transfusion
Animal Research:
Less adhesions, faster healing
18
Hemostasis
Franchise
–
Value
Proposition
Safety:
Plant based technology eliminates many of the safety issues
associated with thrombin based competitors (FloSeal, Baxter)
Ease-of-Use:
Always ready, easy-to-use, and inexpensive
Vitagel Surgical Hemostat
Vitasure
Absorbable Hemostat |
 Pipeline Delivery -
Biosurgery
New delivery system
Flowable
hemostat (OV
collagen)
VitaPrep™
plasma device
Surgical Hemostats*
Preclinical
Clinical
Regulatory
>$500M Hemostasis
Market (>60% flowable)
$2B+ Soft-tissue Market
*These devices have not received regulatory clearance or approval
Expected 2H 2011 Launch
Expected 1H 2012 Launch
FDA IDE filing planned for Q4 2011
Development |
 Bone
Marrow
Concentration
–
Vector
for
cross
selling
Establishes
a
key
cross-selling
linkage
between
Vitoss
and
Vitagel
platforms
Installed base of centrifuges used for for
Vitagel
and Vitoss
(marrow).
Dual utilization within OR increases visibility and efficiency.
In development; no regulatory clearance has been obtained.
|
 Biosurgery
Strategy
Leverage and cross-sell into all Vitoss
hospital accounts
Access via existing relationships in spine/ortho
New marketing materials directed to other specialties
Ob/Gyn, vascular, joint surgeries
Leverage
“facilitates
healing”
claim
Hire biosurgery
specialist sales reps in high potential markets
Improve manufacturing efficiencies and gross margins
Better sourcing of key raw materials
Develop
additional
biosurgery
products
to
leverage
collagen
facility
Developing a flowable
hemostat to access a significant market
segment and leverage collagen facility |
 22 |
 23
Cortoss Bone Augmentation Material
An injectable, bioactive
composite that mimics the
mechanical properties of
human cortical bone
First FDA-cleared alternative
to polymethylmethacrylate
(PMMA) cement for use in
vertebral augmentation
procedure
Indicated for the fixation of
pathological fractures of the
vertebral body using vertebral
augmentation
Patent protected to 2022 |
 Cortoss
Strategy
Develop kyphoplasty cavity creation devices
Aliquot Directional Bone Tamp, then Aliquot Balloon Tamp
Provide complete offering for physician and facility preference
Develop new indications for Cortoss
material
Targeting neuro/ortho
applications in the inpatient OR for sales force
synergy
Cranioplasty
first target indication, ongoing discussions with FDA
Add independent agents for outpatient/IR market
Different focus and call pattern than is optimal for our DSR’s Enhance focus and specialization
within sales force |
 Pipeline
Delivery
-
Fixation
Label expansion 1: cranial
repair**
Aliquot Balloon Bone Tamp**
Aliquot Directional Bone Tamp*
Cortoss
Pipeline
Preclinical
Clinical
Regulatory
$500M VCF Market
$500M
“Outside
of
VCF”
Markets
including…
$100M + Cranial repair market
* Class I exempt device
**These devices have not received regulatory clearance or approval
Expected launch 1H 2011
Regulatory clearance
expected 1H 2012
Regulatory clearance
expected 1H 2012
Development |
 Aliquot Directional Bone Tamp
The Aliquot Directional Bone Tamp is intended to create preferential flow
channels in existing spinal bone structure prior to a vertebral augmentation
procedure. These channels can provide directional filling of bone cement.
Aliquot Directional Bone Tamp
X-rays from device verification
testing in sheep spine |
 Inflatable Bone Tamp
A balloon catheter that will allow
customers to perform balloon-assisted
vertebroplasty with Cortoss
bone
cement.
Cavity
creation
device
-
balloons |
 Differentiating
Core
Capabilities
–
R&D
and
Manufacturing
Fully integrated development engine
In-house
capabilities
from
concept
through
commercial
manufacturing of
highly complex biomaterials products
Scientists and engineers with focus in biomaterials, bioengineering
and chemistry
Special expertise in ceramics, polymers, composites, collagen protein
World class aseptic manufacturing facility
High level clean room and isolators for sterile manufacture and fill
Manufacture of complex biomaterials products which cannot be terminally
sterilized
2010
FDA
clearance
of
only
pepsinized
collagen
facility
in
U.S.
Ultra pure, bovine-derived collagen
All manufacturing capability is highly scalable without additional
investment |
 Vitagel
Aseptic
Manufacturing
-
Isolator |
 Orthovita Collagen Extraction Facility |
 Differentiating
Core
Capabilities
–
Commercial
Organization
Hybrid U.S. Sales Organization
Highly
focused
orthobiologics
and
biosurgery
sales
organization
Strong command and control of 80 to 85 direct sales
representatives
Extend revenue base with low risk from 60+ distributors and
agents
Cross selling opportunity
Adjacent specialized selling opportunity
Commercial Expansion in OUS Markets
Strong results from 2009 launch of direct sales force in U.K.
In process of selecting next direct market
NEW OUS leadership focused on expanding current network of
distributors to high growth markets |
 32
Financial Overview |
 33
Financial Summary
1
2007
Net
loss
includes
a
$16.6mm
charge
for
the
repurchase
of
a
royalty
obligation
Dollars in Millions
2007
2008
2009
2010 Guidance
Sales
Gross Margin
SG&A Expense
R&D Expense
Operating Loss
Net Loss
Cash at September
30, 2010
$58.0
$76.9
65%
66%
68%
$92.9
$94.0 to $96.0
$(1.0) to $(2.0)
$44.6
$6.4
$(13.7)
$(29.9)
$(10.8)
$(9.2)
$6.7
$53.5
$57.2
$6.8
$(1.1)
$(3.9)
$20.9
1 |
 THANK
YOU |