Starting a Fundable Medical Device Company Christopher Porter - - PowerPoint PPT Presentation
Starting a Fundable Medical Device Company Christopher Porter - - PowerPoint PPT Presentation
Starting a Fundable Medical Device Company Christopher Porter Medical Genesis Christopher Porter, PhD n Chemical Engineer/Material Science n 40 yrs in Medical Industry in Product Development and Management n Serial Entrepreneur/Intrapreneur
Christopher Porter, PhD
n Chemical Engineer/Material Science n 40 yrs in Medical Industry in Product
Development and Management
n Serial Entrepreneur/Intrapreneur
- 6 Successful Startups
- 2 Divisions (J & J and Pfizer)
- Multiple exits through IPOs and Sale of Company
n 30 + Products on Market n 50+ Patents n Early Stage Life Science Company Advice
- LIFE SCIENCE WASH, COMOTION, WINGS, W-FUND,
LSDF, COULTER
- Over 100 companies/year
BACKGROUND
Medical Product’s Characteristics
n Highly Regulated n High Value/High Margins n Different Types
- Drugs
- Biologics
- Diagnostics
- Devices
n Third Party Payers n Medical IT has a different model
STARTING AN ENTERPRISE
Proxima
- A catheter system to treat
brain and breast cancer with radiation
- Sold to Cytec in 2005
EXAMPLE
TUMOR
Resected Tumor Cancerous Margins EXTERNAL BEAM RADIATION FROM DIFFERENT DIRECTIONS Damage to Healthy Tissue Missing the Target M
Balloon with Radioactive Fluid Low Level- Localized and Precise Radiation
Gliasite Clinical Data
ADVANTAGES
n Less expensive than fractional
radiation
n Does not need specialized and
expensive equipment
n Faster Treatment Time n Easier on Patients n Less Healthy Tissue Damage n Arguably more effective treatment n Can be adapted to other cancers
MAMOSITE
Radiation following a lumpectomy for Breast Cancer
GOING FORWARD
GENESIS OF A MEDICAL PRODUCT COMPANY
CONCEPT
DEVELOPMENT AND CLINICALS COMMERCIALIZATION
EXIT STRATEGY
IDEA
Feasibility Proof of Concept FDA Approval Sales and Profitability IPO or Sale of Company
VALUE ADDER MILESTONES
COMPELLING UNMET NEED
FUNDABLE STAGES OF A MEDICAL COMPANY
- 2. Proof of Concept
- 4. Commercialization
- 5. Liquidity (Exit Event)
3.Final Development and Regulatory Approval
- 1. Fundable Idea (Feasibility)
- 0. Initial Concept (IDEA)
$ $ $
EARLY STAGES PLANNING
Business Plan
LATER STAGES EXECUTION
COMMON MISTAKES
n Elegant solutions to non-problems
- Technology in search of a need of a solution
- Invented needs
- Funding the lab instead of advancing the company
n Product, not an company
- Small market
- Evolutionary, not Revolutionary
- Belongs with an Existing Company
n Wasting resources on overly complex products
- Features that are not important
- Increases cost, complexity and risk
- In love with the technology
COMMON MISTAKES
n Not doing enough upfront homework
- Not addressing critical items
- Don’t talk to potential customers
- Get far down the path before the mistake is
clear
n Non-investable management pitching the
company
- Better to have no CEO rather the wrong one
n Trying to raise investor money to soon
- Have not fully addressed critical milestones
- 10 resurrections to take care of one crucifixion
FUNDING
Staged Approach
FEASABILITY OK PROOF OF CONCEPT OK PRODUCT DEVELOPMENT OK IDEA
$ $ $
TIME
$
$
Probability of Success VALUE OF COMPANY
LOW HIGH
Value Increases Discreetly
TIME COMPANY VALUE
IDEA PROOF OF CONCEPT FDA APPROVAL
SIGNIFICANT SALES, POSITIVE CASH FLOW
$
LIQUIDITY
RISK
VALUE RISK
HIGH LOW Value Added Milestones
FUND RAISING AND DILUTION
FOUNDERS (Common)
- 5. PUBLIC OFFERING
- 4. COMMERCIALIZATION
- 3. FDA APPROVAL
- 2. PROOF OF CONCEPT
IDEA, KNOWHOW, IP SWEAT-EQUITY $ $ $ $ PUBLIC FUNDING POINT VALUE RECEIVED STOCK IN COMPANY
- 1. FEASABILITY
$ INVESTORS (Preferred)
STAGES OF A COMPANY
IDEA- (DEFINE A NEED AND PRODUCT TO FILL IT) DEMONSTRATE PROOF OF CONCEPT COMPLETE DEVELOPMENT AND OBTAIN REGULATORY APPROVAL COMMERCIALIZATION LIQUIDITY EVENT (IPO OR SELL IT) START 6-18 Mo 0.2-1.0 MM$ 1-3 YR 5-15 MM$ 1-3 YR 10-20 MM$ END 0.3-1.0 MM $ 5-10 MM $ 20-40 MM$ 100-200 MM$ STAGE TIME AND $s RAISED PRE-MONEY VALUE
Value and Ownership
20 40 60 80 100 120
Start 1st 2nd 3rd Liquidity
Round % or $MM
% Ownership Founders Value Company Value
Sources of Funding
n NON DILUTIVE
- Government Grants
- Foundations
- Other Grants
n EARLY STAGES (DILUTIVE)
- Sweat Equity
- Self, Friends and Family
- Angels
- Seed Funds
n LATER STAGES
- Existing Company (Strategic Investors)
- Venture Capital
n LIQUIDITY
- Public (IPO)
- Sell the company
Venture and Angel Investors
n Good ones can add a lot of value to the
company
- Connections and Networking
- Know How and Advice
- Credibility
- Continued source of funding
n Their job is to maximize the return for
themselves or their funds
n Want to structure as strong a company as
possible -- even at the expense of the founders
n Will try and get control of the company
WHAT INVESTORS ARE LOOKING FOR
n A good Return on Investment
- Liquidity Event
n Sell the Company or Idea n Public Offering
- High Returns
n Initial value of the venture n Time it takes to get to liquidity n How much total money will go into it by that time n What will be worth at the liquidity event
n Is this worth it for investor to work on
- Size of the fund
- Other Opportunities they have to make an investment
POTENTIAL DEAL KILLERS
n Bet People as Much as (more than)
Ideas
n Evolutionary vs. Revolutionary n Product vs. a Company n Market Potential Too Low n No or Poor Patent Position n Reimbursement is unlikely (Make it
and they will come fallacy)
n Too high expectation of initial value n Regulatory is too risky n Overly optimistic projections
What I Have Learned
n Most excited about the things you
know the least about- do your homework
n You don’t know what you don’t
know - find experienced help
n The last person you want to fool
is your self – People fall in love with their own ideas and will not listen
n Invest in only things that create
value
What I Have Learned
n Don’t be too valuation sensitive
- 100% of nothing is not as valuable of 25%
- f something
- Get good investors
n Always raise money before you need it n Raise enough money-It always takes
longer and cost more than you think
n The largest predictor of success