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Introductory Remarks Bob Dickson CFO-CardiacAssist [email protected] 724-272-1527

Rivers Club Pmd 091108

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Renal Solutions-a western Pennsylvania success story.

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Page 1: Rivers Club Pmd 091108

Introductory Remarks

Bob DicksonCFO-CardiacAssist

[email protected]

Page 2: Rivers Club Pmd 091108

The Renal Solutions StoryPete DeComo, CEO

Life Sciences ExecutivesRivers Club

September 11, 2008

Page 3: Rivers Club Pmd 091108

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

Page 4: Rivers Club Pmd 091108

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

Page 5: Rivers Club Pmd 091108

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

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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

Page 7: Rivers Club Pmd 091108

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

Page 8: Rivers Club Pmd 091108

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

Page 9: Rivers Club Pmd 091108

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

Page 10: Rivers Club Pmd 091108

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

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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

Page 12: Rivers Club Pmd 091108

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 $

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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

Page 14: Rivers Club Pmd 091108

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!

Page 15: Rivers Club Pmd 091108

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

Page 16: Rivers Club Pmd 091108

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.

Page 17: Rivers Club Pmd 091108

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!

Page 18: Rivers Club Pmd 091108

The Allient® Sorbent Hemodialysis System

Questions & Answers

Thank you!

Peter M. DeComoRenal Solutions Inc.

[email protected] x104

Page 19: Rivers Club Pmd 091108

Future Presentation

Charlie SmithChief Investment Officer

Fort Pitt CapitalOctober 16, 2008

7:45am Rivers Club