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Renal Solutions-a western Pennsylvania success story.
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The Renal Solutions StoryPete DeComo, CEO
Life Sciences ExecutivesRivers Club
September 11, 2008
In Appreciation
No successful entrepreneur does it alone!
• My deepest appreciation to all who have
supported me– My wife Kate and my daughters Nicole and Kristen
– The Renal Solutions team
– My investors:• Gary Glausser – Birchmere Ventures
• Mike Stubler – Draper Triangle Ventures
– The many other individuals and organizations
The Renal Solutions Vision
To develop and commercialize a hemodialysis system suitable for the institutional and home settings.
In the home setting the goal is to facilitate;
• Self Administration – More Dialysis!• Improved clinical, quality of life and cost outcomes• Improved dialysis center performance metrics
Renal Solutions History• Incorporated in August 2000
• Moved the Company from Lafayette IN to Pittsburgh in 2001
• Corporate headquarters & distribution in Warrendale, PA
• Sorbent manufacturing in Oklahoma City, OK– Acquired SORB™ in April 2001 (RSI Had no cash or value at the time!)
• Currently 65 employees
• FDA clearance in June of 2005 and April 2006
• CE Marking received in November 2005
• Initiated a controlled product launch January 2007
• Basically pre-revenue through 2007
• RSI Acquired by Fresenius in November, 2007
The Allient® System - Benefits• Treatments anytime & anywhere• Freedom from water purification hassles,
installation cost and maintenance• 1 piece of equipment for multiple treatment
options• Exceptional dialysate purity• Gentle, customized, patient-driven therapy• Closed fluid circuit• No internal disinfection/sterilization• Simple single- or dual-lumen vascular access
choice• Competency easily achieved
Sorbent Cartridge – Heart of RSI Technology
Four Layers (Bottom to Top) :
Activated Carbon & PurificationOrganics, Middle Molecules
Urease LayerUrea --> (NH4)2CO3
Zirconium PhosphateCation Exchange
Zirconium OxideAnion Exchange
• Regenerates >100L of high purity dialysate from 6L tap water• No need to be connected to water or drain source• Base technology for true portability and wearability
Renal Solutions Value Proposition• There is a pent-up demand based upon a need for:
– Better clinical & quality of life outcomes– Reduced cost of care– Less technological complexity– More dialysis center capacity & improved financial metrics
• Disruptive & Transformational Technology– Only 1 ½ gallons of tap water w/o tethered to water supply or drain– Short or Long duration, Higher Therapeutic Dose (Dose per $)– Inherent Safety – single lumen, small dialysate volume, etc.– Ease of Use – Human factor considerations, i.e., GUI, training tools– No patient investment or changes to home required– Enabler for home therapy – improved outcomes– Low Risk Investment – Established acute market while home shifts
Renal Solutions - Investment Considerations!
• $50 Billion Worldwide Dialysis Market
• Patient dialysis dose is inadequate – 24% mortality rate in the US
• Home Dialysis is an underserved market with <1% at home
• We’ve solved the water access challenge!
• Domain Experienced Management Team
• Reimbursement is Well Established
• Low Risk FDA Regulatory Pathway
• Current Traction in the Marketplace
Financing History
• Initiated a Series A financing in Sept. 2001• Public and Private Equity Markets crashed
Tech bubble had burst 9/11 terrorist attack Major accounting scandal’s
• Initial target of $7.5 MM for the Series A• Had raised $3.0 MM in seed money
Financing Results
• Raised a total of $23.2 MM in the Series A (11/02)
• 15 months to close vs. the pre-bubble 6 months
• Also secured (while still pre-revenue): $1.0 MM equipment term loan with GE
$1.0 MM line of credit with SVB
$5.0 MM in venture debt
• Raised $17.1 MM the Series B (3/05)
• Additional $20 MM with a unique debt structure (2/07)
TOTAL of $40 MM in equity capital & $25 MM in debt
Financing Perspective
• A steady increase in VC backed deals from 1995 thru 2000.
• 2001-2003, private equity $$ down significantly along with M&A’s & IPO’s.
• Recovery in 2nd half of 2003 though less than 2002 total.
• Q1-04 investments 5% greater than Q4-03 & up 25% over Q1-03 but deal flow was down 15%.
• IPO activity has followed the same general pattern thru Q1-04 but has tailed off while private equity has remained robust.
1995 1,313 $6.9 B
2000 6,101 $94 B
2001 3,194 $36 B
2002 2,269 $22 B
2003 1,973 $18 B
Year # Deals VC $
So What Happened??
• Raised a total of $40MM in Private Equity & $25MM in debt financing
• Completed development of the Allient® Sorbent Hemodialysis System
• Commenced a controlled market launch & clinical study in early 07’
• Was acquired for $200MM in November 07’$ 200X 2007 revenue of $1.0MM$ 5X return for investors
Why $200MM for a Pre-Revenue Co.?
• A large market of $2 billion plus with unmet needs.
• A disruptive & transformational technology solution.
• A strong pipeline of future products.
• Significant patent & trade secret portfolio.
• A strong foundation in place in order to commercialize.
• The potential of $200MM in revenue within 5 years and
a $500MM market cap within 2 years post launch.
Think Big, Act Big, Be Big!
Benefits for the Region
• In the beginning I was told many times; don’t do it in Pittsburgh!
• The success of Renal Solutions enhances the credibility and visibility of the region re; economic development & future start-up funding/growth.
• Renal Solutions will remain in the region:– As a wholly owned subsidiary of FMC– Employment will continue to grow– Pete DeComo will remain as the CEO
Pete’s “TOP TEN LIST” of Start-up Fallacies:
1. You have a great idea and raising money will not be a problem.
2. You can get it done faster and cheaper than the competition.
3. Dilution is a bad thing.
4. You have the best talent on the street.
5. You do not need patent protection, the trade secrets are significant.
6. Success in the market is totally based upon technology superiority.
7. It is a low risk and expedited regulatory pathway.
8. Scientific founders are all wonderful and should stay forever.
9. Management and VC Boards are strategically aligned.
10. Venture Capitalists like risk.
The Moral of the Story for Entrepreneurs
• Believe when others Do Not
• Persevere when others Would Not
• Know the market, the problem and the solution; others Will Not
• Take calculated risk when others say you Should Not
• Be humble when others Cannot
• Focus, Focus, Focus …. Competitors Forgot Foot Note: Spend Less than 5% of your time thinking Exit!!!
• Have fun, love your family, friends & employees … It’s only a job and Worry
Not!
The Allient® Sorbent Hemodialysis System
Questions & Answers
Thank you!
Peter M. DeComoRenal Solutions Inc.
[email protected] x104
Future Presentation
Charlie SmithChief Investment Officer
Fort Pitt CapitalOctober 16, 2008
7:45am Rivers Club