Resources, Activities, Costs

UCSF Diagnostics Cohort

Fall 2013

Todd Morrill

1

2

Remember how we will fit DX into the BMC?

IP Resources in Dx

• Original / core license – Licensed or filed

– Nothing to talk about unless it is protected

– Analyte, test method, reagents, apparatus, etc.

• Freedom to operate – Much harder to get. Make reasonable assumptions

– US PTO and search engines can help

• Protection from competition – Very hard

Financial Resources in Dx

• Cost to develop / burn rate

• Time to market

• Pre-launch builds

• Incremental funding if necessary

$10M

$15M

2012

Series A

$3.5 MM

Ca

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al

Mile

sto

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s

$5M

Initialize

De

sig

n

Mile

sto

ne

s

Re

gu

lato

ry/ IP

M

ilesto

ne

s

Q1 Q2 Q3 Q4

2013

Q1 Q2 Q3 Q4

2014

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2015 2016

System

2017

Q1 Q2 Q1 Q2 Q3 Q4

2018

Q3

$30M

$20M

$40M

6 12/4/2009

Proof of Concept

Provisional Patent

Beta-Version Testing

Laboratory Prototype

Beta Prototype

Technology Licensing

Financial / Operations Timeline

Pilot Studies

MammOptics MammOptics

$10M

$15M

2012

Series A

$3.5 MM

Ca

sh

Re

se

rve

C

linic

al

Mile

sto

ne

s

$5M

De

sig

n

Mile

sto

ne

s

Re

gu

lato

ry/ IP

M

ilesto

ne

s

Q1 Q2 Q3 Q4

2013

Q1 Q2 Q3 Q4

2014

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2015 2016

Series B

$9 MM

System

2017

Q1 Q2 Q1 Q2 Q3 Q4

2018

Q3

$30M

$20M

$40M

7 12/4/2009

IC and Processing Patents

Marketable Product

Beta-Version Testing

Application and System

Patents

IRB / IDE

Beta Prototype

Financial / Operations Timeline

Pilot Studies

Regulatory / Clinical

Laboratory Prototype

MammOptics MammOptics

$10M

$15M

2012

Ca

sh

Re

se

rve

C

linic

al

Mile

sto

ne

s

$5M

De

sig

n

Mile

sto

ne

s

Re

gu

lato

ry/ IP

M

ilesto

ne

s

Q1 Q2 Q3 Q4

2013

Q1 Q2 Q3 Q4

2014

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2015 2016

Series B

$9 MM

System

2017

Q1 Q2 Q1 Q2 Q3 Q4

2018

Q3

Series C

$30.5 MM $30M

$20M

Regulatory / Clinical

$40M

8

IC and Processing Patents

Application and System

Patents

IRB / IDE

Cat III CPT

Second Release

1st Release

Test

US Interim Trials US Pivotal Clinical Trials

Publication

Financial / Operations Timeline

Pilot Studies

MammOptics MammOptics

$10M

$15M

2012

Ca

sh

Re

se

rve

C

linic

al

Mile

sto

ne

s

$5M

De

sig

n

Mile

sto

ne

s

Re

gu

lato

ry/ IP

M

ilesto

ne

s

Q1 Q2 Q3 Q4

2013

Q1 Q2 Q3 Q4

2014

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2015 2016 2017

Q1 Q2 Q1 Q2 Q3 Q4

2018

Q3

Launch

Series C

$30.5 MM $30M

$20M

Regulatory / Clinical

Series D

$35 MM

$40M

9 12/4/2009

Clinical Results

Second Release

Initial Product Launch

Non-Specific Codes

2nd Release Test

Publication

US Interim Trials

FDA – Class II – 510 (k) with Clinical Trials

Publication

Financial / Operations Timeline

US Pivotal Clinical Trials

MammOptics MammOptics

$10M

$15M

2012

Ca

sh

Re

se

rve

C

linic

al

Mile

sto

ne

s

$5M

De

sig

n

Mile

sto

ne

s

Re

gu

lato

ry/ IP

M

ilesto

ne

s

Q1 Q2 Q3 Q4

2013

Q1 Q2 Q3 Q4

2014

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2015 2016 2017

Q1 Q2 Q1 Q2 Q3 Q4

2018

Q3

Launch

$30M

$20M

Regulatory / Clinical

Series D

$35 MM

M&A / IPO

$50 MM $40M

12/4/2009

Clinical Results

Initial Product Launch

Specific Codes (Cat. I CPT / APC)

Non-Specific Codes

Publication

Post-Market Clinical Studies

FDA – Class II – 510 (k) with Clinical Trials

Financial / Operations Timeline MammOptics MammOptics

$10M

$15M

2012

Series A

$3.5 MM

Ca

sh

Re

se

rve

C

linic

al

Mile

sto

ne

s

$5M

Initialize

De

sig

n

Mile

sto

ne

s

Re

gu

lato

ry/ IP

M

ilesto

ne

s

Q1 Q2 Q3 Q4

2013

Q1 Q2 Q3 Q4

2014

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2015 2016

Series B

$9 MM

System

2017

Q1 Q2 Q1 Q2 Q3 Q4

2018

Q3

Launch

Series C

$30.5 MM $30M

$20M

Regulatory / Clinical

Series D

$35 MM

M&A / IPO

$50 MM $40M

11 12/4/2009

Proof of Concept

Pilot Studies

IC and Processing Patents

Marketable Product

Provisional Patent

Beta-Version Testing

Application and System

Patents

IRB / IDE

Clinical Results

Second Release

Initial Product Launch

Specific Codes (Cat. I CPT / APC)

Non-Specific Codes

1st Release

Test

2nd Release Test

Publication

Post-Market Clinical Studies

Beta Prototype

US Interim Trials

FDA – Class II – 510 (k) with Clinical Trials

Publication

Financial / Operations Timeline

Cat III CPT

US Pivotal Clinical Trials

Laboratory Prototype

Technology Licensing

MammOptics MammOptics

© 2012 Steve Blank

Activities

• Development plan

• It takes a long time to get financed!

– Limited CEO resource

• Product validation aka clinical trials

– Sensitivity and selectivity specs

– Validation study: patients, time, cost

– Regulator who will oversee it

© 2012 Steve Blank

15

Remember how we will fit DX into the BMC?

Next week

• Close-to-final slide on reimbursement – Codes you will use and associated $$ value – Justification for those codes – Estimated price, and JUSTIFY the difference!

• Close-to-final slide on regulation – What agency, division, etc. will provide approval – Estimated time-to-approval following data submission – Any other regulatory issues

• Close-to-final slide of clinical trials – How many samples / patients – Estimated cost in $$, time and other resources (e.g. your time)

• Close-to-final slide on ecosystem – With flows including dollars and estimated amounts

• Slides as per the syllabus

Upcoming schedule

• Nov 19 – Your final regular presentation

• Nov 26 – No class

• Dec 3 – Training session for the final

• Dec 10 – Final presentations etc.

Please don’t let customer interviewing languish during Thanksgiving, or after…

Open Office Hours

• Wed Nov 13 – most of the day

• Thu Nov 14 – after 2pm

• Mon Nov 18 – most of the day

Please set up the call as soon as possible in advance. I may (not) be available short notice.