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Funding a Medical Device
Startup in the Current Economy
       Michael J. Weickert, PhD
          President and CEO
     S.E.A. Medical Systems, Inc.
    President, Wit Creek Consulting
Who Am I?
• Michael J. Weickert
• PhD Genetics, UW Madison, NIH, NCI
• Biotech Industry since 1992
   – Bay area since 1998; Nektar, CBO StrataGent, CBO Corium
• President and CEO S.E.A. Medical Systems, Inc.
   – Medical device company in Sunnyvale, CA
• President Wit Creek Consulting
   – Business strategy, business plan consultancy
• Member Life Science Angels
   – Member medical device and Bio screening committees
• Start-up Advisor
   – Lypro Biosciences, NanoBioSciences
• Venture Partner Kranenberg Fund
• Limited Partner Quantum Technology Partners
Agenda
• What has the current economy done to
  investing?
  – How bad is it?
• What can a medical device company do to
  raise funds now?
  – Is there any hope?
We have fallen off a cliff: 1Q09 dollars
 down 61%, deals down 45% from 1Q08




Quarterly investment activity was down 47 percent in dollars and 37 percent in
deals from the fourth quarter of 2008 when $5.7 billion was invested in 866 deals.
The quarter, which saw double digit declines in every major industry sector,
marks the lowest venture investment level since 1997.
Q1 2009 US Report; www.pwcmoneytree.com
Steep declines across all industries




The Life Sciences sector (Biotechnology and Medical Devices combined)
experienced a 40 percent decline in terms of dollars and a 31 percent drop in deals
with $989 million going into 133 rounds. Investment in Medical Device investments
fell 27 percent to $412 million.
 Q1 2009 US Report; www.pwcmoneytree.com
Deals down all over the country
      Drop >61% in Silicon Valley




Silicon Valley continued to garner the lion’s share of venture capital dollars,
capturing 39 percent of the $3.0 billion invested in US-based companies
throughout the quarter. The New England Region maintained its customary
number two position despite a 51 percent decline in dollars and a 36 percent
drop in deals from the fourth quarter of 2008.
Q1 2009 US Report; www.pwcmoneytree.com
Venture-backed IPOs disappeared
    and M&A activity declined
Not the best of times
 • IPO mkt weak
     – 6 VC backed IPO’s in US in ’08, lowest since 1977, raised $0.5B
       vs $10.3B in ‘07
     – 0 VC backed IPO’s in Q2’08 & Q4’08
     – 1 VC backed IPO in Q3’08
     – 28 IPO’s in China
 •   2002-08: 19,300 companies received funding, 351 IPO’s
 •   Time to IPO:           ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08
 •   # Years from Series A: 4.5 3.3 5.7 5.7 5.6 6.2 7.1 8.3
 •   M&A weak
     –   260 deals (down 27%), $13.9B (down 51%) in ’08 vs. ‘07
     –   40% drop in ’08 to $300B
     –   32 deals >$1B in ’08 vs 80 in ‘07
     –   Median M&A about $80M

Q4 2008 US Report; www.pwcmoneytree.com
Summary/Facts/Predictions
 •   VC’s stop funding many portfolio companies
 •   More layoffs/cost cutting, unemployment up
 •   New Deals must be perfect
 •   All Deals Series A, lots of down rounds
 •   Fewer Deals per fund, higher reserves
 •   VC syndicate quality more important
 •   VC’s fear capital calls produce LP defaults
 •   VC Fundraising problematic
 •   More Government regulation

Q4 2008 US Report; www.pwcmoneytree.com
Sequoia Capital Oct 2008
Sequoia recommends SURVIVAL




                 Sequoia Capital Oct 2008
What can a medical device
 company do to raise funds now?
First things first
• Are you ready to raise funds?
• Are you incorporated?
• Have you set your equity (stock) pool?
• Do you have a business plan?
• Do you have a budget to key milestones?
• Do you have your complete team?
What can a medical device
    company do to raise funds now?
•   Friends and Family       $1-300k

•   Grants                  $100k->1M


•   Angels                  $300k->1M


•   Venture Capital Firms   $1M->20M


•   Strategic Partners      $200k->20M

•   Product Sales              ??
Friends and Family               $1-300k



• Investors (even Angels) expect you to
  raise $200-500k from friends and family
  before seeking professional investment
• Lowers risk
  – Fund early, often riskiest milestones
  – Shows people are willing to trust you with
    their money
How do you raise friends and
           family funds?
• Most should qualify as “Accredited Investor”
• Treat as professional investors
  – Provide Business Plan, presentation, prospectus,
    investment contract
• Investment is opportunity for people to
  participate in an exciting company with
  tremendous growth potential
  – If you don’t believe this, don’t ask ANYONE to invest
Type of Friends and Family
            Investments
• Priced round
  – Equity (stock) sold at set price – investors receive a
    percentage of the company
  – Pros: investors like clear stake in the company
  – Cons: sets price that can be difficult to increase in
    subsequent investment rounds
• Convertible debt
  – Investors loan money which can be converted into
    equity at the first professional venture round, often at
    a discount
  – Pros: professional investor(s) set the price
  – Cons: cash is owed to the investors if no equity
    conversion takes place
SBIR, STTR Grants                                 $100k->1M



• SBIR (Small Business Innovative Research) is a federal
  set-aside program aimed at supporting R&D in US
  owned small businesses (companies with less than 500
  employees)
   – Success rate on first time SBIR Phase I grants ~15%
• NIH and NSF are among 10 federal agencies which set
  aside 2.5% of the total funds they award for research
  grants to be distributed through SBIR/STTR
• NIH solicitations are published on its website and are
  used to support research in a well defined scientific area
  and/or in a high priority program.
   – In 2003 more than 80% of the awards allocated were unsolicited
     (investor-initiated research grants). The investigator initiates the
     research and submits a grant application within an area that is
     relevant to the NIH
   – http://grants.nih.gov/grants/guide/index.html
Top 10 recipients of NIH SBIR and STTR
        Funds in fiscal year 2007
           (millions of dollars)
Angel Investors                   $300k->1M



• “Accredited Investors” who provides capital for a
  business start-up
• Some angel investors organize into angel groups or
  angel networks to share research and pool their
  investment capital
• Angel investment accounts in total for almost as much
  money invested annually as all venture capital funds
  combined, but into more than ten times as many
  companies (US$26 billion vs. $30.69 billion in the US in
  2007, into 57,000 companies vs. 3,918 companies).
• Average angel funding in 2007, ~$450k. Range from a
  few thousand, to a few million dollars.
Angel funding is down too
• Angel investing dollars dropped by 26.2 percent
  last year ($19.2 billion vs. $26 billion in 2007)
• Entrepreneurs receiving funding was relatively
  unchanged from 2007 (55,480 entrepreneurs
  last year vs 57,120 in 2007)
• Angel investment 2008 sectors:
   –   Healthcare-related businesses = 16%
   –   Software = 13%
   –   Retail = 12%
   –   Biotech ventures = 11%
   –   Energy = 8%
   –   Media = 7%
2008 Angel Market Analysis by the Center for Venture Research at the University of
New Hampshire
Angelsoft* deal funnel from last 12
             months

                                                            21112 Submitted
                                                            1718     In Screening
                                                            1185     Invited to Present
                                                            679      In Due Diligence
                                                            444      Invested

Only a small number of companies who apply get funded. This chart shows
how many make it through the different stages of the Angel Group process,
based on data from our most active groups.
*As the exclusive deal management tool to 451 angel groups and VCs and 17,551
investors, Angelsoft processes over 3,200 funding applications a month. This live access
to investment data allows us to report trends in the early stage investment market.
Venture Capital
• Provide private equity capital typically to early-
  stage, high-potential, growth companies
• Generate a return through an eventual
  realization event such as an IPO or trade sale
  (M&A) of the company
• Venture capital investments generally made as
  cash in exchange for shares in the invested
  company
• Venture capital investors invest primarily in
  companies in high technology industries such as
  biotechnology and ICT
  – VCs fund ~2% of companies they review
Even now some VCs are investing:
   most active venture investors 1Q2009




Q1 2009 US Report; www.pwcmoneytree.com
Strategic Partners
Who has…
• Expertise to develop your product
• Markets similar/related/complimentary
  product(s) to the same customer(s)
• Competes with a product inferior to yours
• Has aspirations to sell to the same
  customers you are targeting
• Might be a potential acquirer of your
  company/product(s)
Engaging Strategic Partners
• Technology conferences for related
  industry scientists
• Partnering conferences for medical
  devices
• High level introductions to strategic partner
  management
• Contract Business Development
  professional
Strategic partnership models
• Support for technology/product development
• Feasibility = modest cash for Proof-of-principle
  demonstration ($100k-1M)
• Option = first right of refusal for license/acquisition of
  technology/product ($100k-2M, may include equity
  purchase)
• Partnership = development support for defined
  product/technology effort (≥$500k up front, development
  costs, milestones, royalties, may include equity
  purchase)
• Structured buy-out = pre-priced acquisition in which
  shareholders receive cash when pre-agreed milestones
  are achieved
Reasons for optimism for medical
       device companies
• Medical device is a strong industry in
  California and the bay area
• Less affected by downturn than other
  biotechnology - viewed as:
  – More conservative investment than drug
    development
  – More capital efficient
Michael J. Weickert, PhD
President and CEO
S.E.A. Medical Systems, Inc.
President, Wit Creek Consulting
             www.seamedical.com
              www.witcreek.net
             mweickert@gmail.com
                650-218-1840

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Funding A Medical Device Startup In The Current Economy

  • 1. Funding a Medical Device Startup in the Current Economy Michael J. Weickert, PhD President and CEO S.E.A. Medical Systems, Inc. President, Wit Creek Consulting
  • 2. Who Am I? • Michael J. Weickert • PhD Genetics, UW Madison, NIH, NCI • Biotech Industry since 1992 – Bay area since 1998; Nektar, CBO StrataGent, CBO Corium • President and CEO S.E.A. Medical Systems, Inc. – Medical device company in Sunnyvale, CA • President Wit Creek Consulting – Business strategy, business plan consultancy • Member Life Science Angels – Member medical device and Bio screening committees • Start-up Advisor – Lypro Biosciences, NanoBioSciences • Venture Partner Kranenberg Fund • Limited Partner Quantum Technology Partners
  • 3. Agenda • What has the current economy done to investing? – How bad is it? • What can a medical device company do to raise funds now? – Is there any hope?
  • 4. We have fallen off a cliff: 1Q09 dollars down 61%, deals down 45% from 1Q08 Quarterly investment activity was down 47 percent in dollars and 37 percent in deals from the fourth quarter of 2008 when $5.7 billion was invested in 866 deals. The quarter, which saw double digit declines in every major industry sector, marks the lowest venture investment level since 1997. Q1 2009 US Report; www.pwcmoneytree.com
  • 5. Steep declines across all industries The Life Sciences sector (Biotechnology and Medical Devices combined) experienced a 40 percent decline in terms of dollars and a 31 percent drop in deals with $989 million going into 133 rounds. Investment in Medical Device investments fell 27 percent to $412 million. Q1 2009 US Report; www.pwcmoneytree.com
  • 6. Deals down all over the country Drop >61% in Silicon Valley Silicon Valley continued to garner the lion’s share of venture capital dollars, capturing 39 percent of the $3.0 billion invested in US-based companies throughout the quarter. The New England Region maintained its customary number two position despite a 51 percent decline in dollars and a 36 percent drop in deals from the fourth quarter of 2008. Q1 2009 US Report; www.pwcmoneytree.com
  • 7. Venture-backed IPOs disappeared and M&A activity declined
  • 8. Not the best of times • IPO mkt weak – 6 VC backed IPO’s in US in ’08, lowest since 1977, raised $0.5B vs $10.3B in ‘07 – 0 VC backed IPO’s in Q2’08 & Q4’08 – 1 VC backed IPO in Q3’08 – 28 IPO’s in China • 2002-08: 19,300 companies received funding, 351 IPO’s • Time to IPO: ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08 • # Years from Series A: 4.5 3.3 5.7 5.7 5.6 6.2 7.1 8.3 • M&A weak – 260 deals (down 27%), $13.9B (down 51%) in ’08 vs. ‘07 – 40% drop in ’08 to $300B – 32 deals >$1B in ’08 vs 80 in ‘07 – Median M&A about $80M Q4 2008 US Report; www.pwcmoneytree.com
  • 9. Summary/Facts/Predictions • VC’s stop funding many portfolio companies • More layoffs/cost cutting, unemployment up • New Deals must be perfect • All Deals Series A, lots of down rounds • Fewer Deals per fund, higher reserves • VC syndicate quality more important • VC’s fear capital calls produce LP defaults • VC Fundraising problematic • More Government regulation Q4 2008 US Report; www.pwcmoneytree.com
  • 11. Sequoia recommends SURVIVAL Sequoia Capital Oct 2008
  • 12. What can a medical device company do to raise funds now? First things first • Are you ready to raise funds? • Are you incorporated? • Have you set your equity (stock) pool? • Do you have a business plan? • Do you have a budget to key milestones? • Do you have your complete team?
  • 13. What can a medical device company do to raise funds now? • Friends and Family $1-300k • Grants $100k->1M • Angels $300k->1M • Venture Capital Firms $1M->20M • Strategic Partners $200k->20M • Product Sales ??
  • 14. Friends and Family $1-300k • Investors (even Angels) expect you to raise $200-500k from friends and family before seeking professional investment • Lowers risk – Fund early, often riskiest milestones – Shows people are willing to trust you with their money
  • 15. How do you raise friends and family funds? • Most should qualify as “Accredited Investor” • Treat as professional investors – Provide Business Plan, presentation, prospectus, investment contract • Investment is opportunity for people to participate in an exciting company with tremendous growth potential – If you don’t believe this, don’t ask ANYONE to invest
  • 16. Type of Friends and Family Investments • Priced round – Equity (stock) sold at set price – investors receive a percentage of the company – Pros: investors like clear stake in the company – Cons: sets price that can be difficult to increase in subsequent investment rounds • Convertible debt – Investors loan money which can be converted into equity at the first professional venture round, often at a discount – Pros: professional investor(s) set the price – Cons: cash is owed to the investors if no equity conversion takes place
  • 17. SBIR, STTR Grants $100k->1M • SBIR (Small Business Innovative Research) is a federal set-aside program aimed at supporting R&D in US owned small businesses (companies with less than 500 employees) – Success rate on first time SBIR Phase I grants ~15% • NIH and NSF are among 10 federal agencies which set aside 2.5% of the total funds they award for research grants to be distributed through SBIR/STTR • NIH solicitations are published on its website and are used to support research in a well defined scientific area and/or in a high priority program. – In 2003 more than 80% of the awards allocated were unsolicited (investor-initiated research grants). The investigator initiates the research and submits a grant application within an area that is relevant to the NIH – http://grants.nih.gov/grants/guide/index.html
  • 18. Top 10 recipients of NIH SBIR and STTR Funds in fiscal year 2007 (millions of dollars)
  • 19. Angel Investors $300k->1M • “Accredited Investors” who provides capital for a business start-up • Some angel investors organize into angel groups or angel networks to share research and pool their investment capital • Angel investment accounts in total for almost as much money invested annually as all venture capital funds combined, but into more than ten times as many companies (US$26 billion vs. $30.69 billion in the US in 2007, into 57,000 companies vs. 3,918 companies). • Average angel funding in 2007, ~$450k. Range from a few thousand, to a few million dollars.
  • 20. Angel funding is down too • Angel investing dollars dropped by 26.2 percent last year ($19.2 billion vs. $26 billion in 2007) • Entrepreneurs receiving funding was relatively unchanged from 2007 (55,480 entrepreneurs last year vs 57,120 in 2007) • Angel investment 2008 sectors: – Healthcare-related businesses = 16% – Software = 13% – Retail = 12% – Biotech ventures = 11% – Energy = 8% – Media = 7% 2008 Angel Market Analysis by the Center for Venture Research at the University of New Hampshire
  • 21. Angelsoft* deal funnel from last 12 months 21112 Submitted 1718 In Screening 1185 Invited to Present 679 In Due Diligence 444 Invested Only a small number of companies who apply get funded. This chart shows how many make it through the different stages of the Angel Group process, based on data from our most active groups. *As the exclusive deal management tool to 451 angel groups and VCs and 17,551 investors, Angelsoft processes over 3,200 funding applications a month. This live access to investment data allows us to report trends in the early stage investment market.
  • 22. Venture Capital • Provide private equity capital typically to early- stage, high-potential, growth companies • Generate a return through an eventual realization event such as an IPO or trade sale (M&A) of the company • Venture capital investments generally made as cash in exchange for shares in the invested company • Venture capital investors invest primarily in companies in high technology industries such as biotechnology and ICT – VCs fund ~2% of companies they review
  • 23. Even now some VCs are investing: most active venture investors 1Q2009 Q1 2009 US Report; www.pwcmoneytree.com
  • 24.
  • 25.
  • 26.
  • 27. Strategic Partners Who has… • Expertise to develop your product • Markets similar/related/complimentary product(s) to the same customer(s) • Competes with a product inferior to yours • Has aspirations to sell to the same customers you are targeting • Might be a potential acquirer of your company/product(s)
  • 28. Engaging Strategic Partners • Technology conferences for related industry scientists • Partnering conferences for medical devices • High level introductions to strategic partner management • Contract Business Development professional
  • 29. Strategic partnership models • Support for technology/product development • Feasibility = modest cash for Proof-of-principle demonstration ($100k-1M) • Option = first right of refusal for license/acquisition of technology/product ($100k-2M, may include equity purchase) • Partnership = development support for defined product/technology effort (≥$500k up front, development costs, milestones, royalties, may include equity purchase) • Structured buy-out = pre-priced acquisition in which shareholders receive cash when pre-agreed milestones are achieved
  • 30. Reasons for optimism for medical device companies • Medical device is a strong industry in California and the bay area • Less affected by downturn than other biotechnology - viewed as: – More conservative investment than drug development – More capital efficient
  • 31. Michael J. Weickert, PhD President and CEO S.E.A. Medical Systems, Inc. President, Wit Creek Consulting www.seamedical.com www.witcreek.net mweickert@gmail.com 650-218-1840