misonix incorporated nasdaq: mson. 1 company confidential except for the historical information...
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MISONIX INCORPORATED
NASDAQ: MSON
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COMPANY CONFIDENTIAL
Except for the historical information contained herein, the matters
discussed in this presentation contain forward-looking statements.
The accuracy of these statements is subject to significant risks and
uncertainties. Actual results could differ materially from those
contained in the forward-looking statements. See the Company’s
SEC filings on Forms 10-K and 10-Q for important information
about the Company and related risks.
Safe Harbor Statement
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COMPANY CONFIDENTIAL
Why Misonix?
Would you want to invest in a Company using unique ultrasound technology in these markets?
Prostate Cancer
Breast Cancer
Kidney/Liver Cancers
Liposuction
Neurosurgery
Lithotripsy
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COMPANY CONFIDENTIAL
The Misonix Story
Management at Misonix has embarked on a transition strategy that today has positioned the Company for years of growth. This plan includes:
Major medical device company
Leveraging decades of ultrasound research and existing businesses
Allocating assets to build intellectual property portfolio
Assembling a diversified line of medical devices with the potential for high growth and margins
Developing efficient manufacturing processes and distribution capabilities
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COMPANY CONFIDENTIAL
Track Record of Execution – 5 Years of Progress
* First full year of management team
“Smart Growth”
FY1999 FY2000* FY2004 FY2005
Total Revenue $25 million $29 million $39 million $46 million
Medical Device Revenue
$9 million $12 million $21 million $25 million
Commercialized Medical Devices
1 5 9 9
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COMPANY CONFIDENTIAL
Track Record of Execution – 5 Years of Progress
FY1999 FY2000* FY2004
SGA % of Sales 30% 30% 31.5%
R&D % of Sales 4% 5% 7%
Total Assets $29 million $31.2 million $34.2 million
* First full year of management team
Investing for the Future and To Enhance Shareholder Value
FY2005
32%
8%
$38.1 million
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COMPANY CONFIDENTIAL
Value Proposition at the Core of TransitionLeadership in Ultrasound Medical Devices
Unique Proprietary Products
Gre
at D
eman
d f
or
Pro
du
cts
Lower PriceSensitivity
Un
iqu
e Pro
du
ction
Cap
ability
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COMPANY CONFIDENTIAL
Allocating Assets – Opportunistic Acquisitions*
Expanding product line, manufacturing and servicing capabilities, tactical benefits and
technological prowess
Year Business Strategic Purpose
1999 Focus Surgery HIFU Technology/Multiple Applications
1999 Hearing Innovations New Technology/Application
2000 Sonora Medical Ultrasound Equipment Servicing
2000 CraMar Technologies Ultrasound Equipment Servicing
2000 Sonic Technologies Measurement and Testing Lab
2001 Fibra Sonics Neurosurgery, Liposuction, Lithotripsy
* Certain transactions were investments for less than 100% ownership
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COMPANY CONFIDENTIAL
Current Line of Medical Devices
Unique and Important Products
Product‘ Application ‘
Sonablate 500® Prostate Cancer – worldwide production and sales in Europe
Auto SonixTM Cutting and Coagulation
Lysonix 3000 Surgical Aspirator (Liposuction)
Fibra Sonics Neurosurgery
Sonora Proprietary replacement probes, refurbished
ultrasonic imaging equipment, probe testing
Hisonic Tinnitus and profoundly deaf
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COMPANY CONFIDENTIAL
1999 – MSON contractual relationship and investment
18% fully diluted equity position in Focus Surgery, developer of HIFU technology
Right to produce their products for global distribution (manufacturing margin)
Right to sell the Sonablate 500® for prostate cancer in Europe (manufacturing and distribution margins)
100% rights to worldwide license to market and sell HIFU treatments in Kidney, Liver and Breast (manufacturing and distribution margins)
High Intensity Focused Ultrasound (HIFU)and Focus Surgery
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COMPANY CONFIDENTIAL
The Sonablate 500®
Non-invasive
Phase I in U.S.
Sales in Europe and Asia
Ability to treat radiated tissue
Focus Surgery Sonablate 500® - utilizing High Intensity Focused Ultrasound (HIFU) for treatment of Prostate Cancer
Focus Surgery - Prostate Cancer
Over 1400 successful procedures Worldwide
Over 300 successful procedures in Europe
24 patients in United States under 40 patient IDE
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COMPANY CONFIDENTIAL
Sonablate – Liver, Kidney, Breast and Prostate
Market Size – Annual Incidences
U.S. World
Sonablate Growth Initiatives
Liver 20,000 500,000
Kidney 32,000 118,255
Breast 184,000 1,050,346
Prostate 200,000 543,000
Est. Market
$100 mil.
$100 mil.
$600 mil.
$750 mil.
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COMPANY CONFIDENTIAL
Brigham & Womens Hospital – Fibroids of Uterus
EDAP – Prostate cancer
Epicor – Cardio Arterial Fibrillation
Lyponsonic – Body Sculpting
Therus & Boston Scientific – Internal bleeding
China Medical – New Public Offering of Chinese HIFU Company
Misonix is developing products both internally and externally to meet these market needs
Expanding Use of Ultrasound Technology…
…and Expanding Valuations?
Single HIFU product company acquired by St. Jude Medical for $200 mil. in 6/04 after FDA approval
Single product FDA approved in 4Q04; funding to date of $80+ mil.
$75 Million Valuation
$25 Million Investment
Nasdaq: CMED - Market capitalization of $977 mil. with revenues of $26 mil. all of which are from China.
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COMPANY CONFIDENTIAL
Diversification to Support Short/Long Term Goals
Ultrasound equipment refurbisher (Sonora) Ultrasonic cutting & coagulating system
(Auto SonixTM) HIFU to treat tumors (SB500®) Neurosurgery (FS-1000) Soft tissue aspirator (Lysonix)
Ultrasonic liquid processor (Sonicator) Ductless fume enclosures (Aura) Endoscope Cleaning Products (Guardian)
Medical Devices
Laboratory & Scientific Products
Immediate Cash Flow Generator
Short-term Tactical Importance
Future Growth
Long-term Goal
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COMPANY CONFIDENTIAL
Investments in high growth medical areas funded from cash flow of medical device products in addition to laboratory and scientific products
Make investments consistent with company’s core competency
Manufacturing exclusivity plus the rights to other products in exchange for investment
Generate marketing/manufacturing efficiencies and revenue growth
Apply R&D to develop products for other medical device companies and for ourselves
Growth Strategy
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COMPANY CONFIDENTIAL
Investments in R&D Pave Way for Growth
Digital Platform: Reduce Manufacturing Costs, Ability to Add More Features, Speed to Market, Reduce Size of Products
Indication Strategy/Event Timing
Prostate Cancer European Distribution
FDA Approval
Current
2007/2008
Liver & Kidney Cancers Approval in Selected International Markets
510(k) Approval
June 2005
January 2006
Wound Debridement Clinicals Currently Ongoing
US FDA approved 510(k) device / Canada
Launch
Current
July 2005
First half of calendar 2006 (Est.)
Bone Cutting US FDA Approved 510(k) Device
Clinicals to Start for Spine
First patient treated
Commercial launch
Approved
June 2005
January 2006
Est. end of 2006 – Beginning of 2007
Breast Start Prototype Work on Aspiration of Fibroids of the Breast January 2006
Breast Fibroids and Cancer with HIFU
First half of calendar 2006
Uterus – Fibroids Start Prototype Work on Aspiration of Fibroids of Uterus In research phase
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COMPANY CONFIDENTIAL
Assuming clinical successes, regulatory approval and commercial production
Indication Market Size Per Year
Bone Cutter – Laminectomy $100 million
Wound Debridement $3.0 billion
Hearing $100 million
Prostate Cancer (US) $300 million
Breast Cancer $600 million
Liver & Kidney Cancer $200 million
Market Opportunity for Future Products
$4.30 billion
Annual Market for Existing Products $ .65 billion
Total Annual Market for Existing/Future Products $4.95 billion
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COMPANY CONFIDENTIAL
Distribution Channels
International Reach and Extensive Medical Community Relationships
Distribution Partner Countries Medical Community Relationships
United States (5) Russia
Russia - SB500/Neuroaspirator United Kingdom
United Kingdom – SB500 Austria
Turkey Belgium
Egypt - Neuroaspirator Germany
Italy - SB500/Neuroaspirator
China - Neuroaspirator
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COMPANY CONFIDENTIAL
We Believe We Are The BestUltrasonic Medical Device Company
Balancing economic benefits of direct sales force and partnering with market leaders
With more products in the market and in anticipation of others nearing approval, management has increased spending on sales and marketing activities in FY2005 above level of previous year.
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COMPANY CONFIDENTIAL
Michael McManus, 62, President and CEO
Health care product development and marketing experience as CEO of Jamcor Pharmaceuticals and positions with Pfizer and Revlon
Substantial experience as CEO of New York Bancorp
Richard Zaremba, 50, CFO
20+ years of financial experience with emphasis in technology companies
Dr. W. Paul Constantine, 34, SVP, Marketing, Sales and New Product Development for Medical Devices division
Extensive experience in medical device marketing
Dan Voic, 43, VP, R&D
Background in medical engineering
Management Team
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COMPANY CONFIDENTIAL
Financial Review
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COMPANY CONFIDENTIAL
Revenue ($ in millions)
Fiscal Year
Revenue Momentum
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COMPANY CONFIDENTIAL
$0.03
$0.15
$0.25
$0.19
2002A 2003A 2004A 2005A*
Earnings ($ Per Share)
Fiscal Year
Delivering Profits
Maintaining Strong Profitability While Investing in Future Growth Opportunities
*Before one-time litigation reserve charge of approximately $0.06.
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COMPANY CONFIDENTIAL
EBITDA* ($ in millions)
Actual
EBITDA Positive Trend Continues
Fiscal Year
Healthy Operating Cash Flow From Core Businesses
*Earnings Before Interest, Taxes, Depreciation and Amortization
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COMPANY CONFIDENTIAL
As of: December 31, 2005
Cash and Cash Equivalents $2.7 million
Total Assets $35.2 million
Current Liabilities $9.5 million
Long Term Debt $1.1 million
Total Stockholders Equity $23.8 million
Current Ratio 2.5 to 1.0
Balance Sheet
Ability to Fund Internally or Externally for Implementation of Growth Strategy
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COMPANY CONFIDENTIAL
Results for Strategies Implemented Since 1999
Increased Medical Devices from 1 Product to 9 Products in 2004
Revenue up 85% since 1999 or an average annual increase of 10+%; Medical device revenue up 184%
Acquired and developed internally numerous new technologies/applications; Increased spending on R&D by 247%
Healthy profitability maintained despite increase in spending for future growth through medical device initiatives
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COMPANY CONFIDENTIAL
Focus company to be a pure medical device organization
Continue to focus on delivering sustainable results in the near term
Invest in programs intended to provide more profitable long term growth
Focus on synergistic acquisitions and other strategic alternatives to increase shareholder value
Management Commitment
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COMPANY CONFIDENTIAL
Investment Merits
Premiere platform of medical devices using ultrasonic technology – greatest number of unique products on the market
Internally and externally generated growth
Ability to forge alliances with strong third-party distributors and directly market to customers
Barriers to entry include years of ultrasound research and significant investment in HIFU and other technologies
Healthy balance sheet and cash flow from core businesses
Milestone-driven company focused on attaining growth and enhancing shareholder value
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COMPANY CONFIDENTIAL