liquilume nsf final presentation

Molecular diagnostic devicesthat make every molecule count

Number of Customers

97

LIQUILUME DIAGNOSTICS

Total target opportunity: $5.1 Billion

Holger Schmidt (PI)Prof. Electrical EngineeringUC Santa Cruz

Philip Measor (EL)PhD, Electrical Engineering, UC Santa CruzCEO, LiquiLume Diagnostics, Inc.

Bob Dunkle (IM)MBA, Entrepreneur-in-Residence QB3ABES Partners

Aaron Hawkins (Co-founder)Prof. Electrical and Computer EngineeringBrigham Young University (BYU)

Team members

- Build viable MVP- Identify and win first customers- Develop partnerships and advisors- Set up production- Assess regulation needs

The Business Model Canvas LiquiLume Diagnostics HS / PM / BD 120 03 2012

Key Partners Key Activities Value Propositions

Customer Relationships

Customer Segments

Channels

Revenue StreamsCost Structure

Key Resources

1. Cancer researchers

2. Hospital labs

3. Test labs

4. Physicians

5. Pharmaceutical comps

- Early diagnosis, better treatment (docs)- Unprecedented performance [proteins] (docs, researchers)- Lower test cost, faster [NAT] (test labs, hospital labs, payors)- Companion Dx (pharmaceuticals)- Quality of life (patients)

- R&D (scientists)- IP licensing + filing- Chip manufacturing- Assembly/design

- Chip foundry- acad/industr. research labs to validate- distributors- Potential parent comp.- Regulators

- Proteins: Value-driven (unmatched performance)- NATs: Cost-driven (cheaper, faster, simpler)- Economies of scale: increasing # of biomarkers- Economies of scope: both NATs and proteins on one platform- Fixed costs: ongoing R&D; chip fabrication fairly simple

- Instrument: feature-dependent; negotiable; possibly low- Consumables: fixed; mass/volume discounts- Service contracts- Service sales: test per marker per sample

- Direct purchase- Distributors- Website sales- Trade shows / conf.s- On-site setup- Service contracts

- On-site support- Co-develop (research)- Web forum

Designed for: Designed by: On:

Iteration:

Original value propositions

Detect individual molecules rapidly and inexpensively

Nucleic acid testing (NAT) Protein biomarkers• save cost • unprecedented sensitivity

Standard Nucleic Acid Testing Workflow

Take sample

Mix sample and probes

Extract DNA/RNA

Thermal cycles Analysis

Labor intensive, subject to inaccuracies at low concentrations, high cost

LiquiLume Workflow

Low volume sample

On-chip sample prep

Add to disposable chip

Run Assay Read out result

Add reagents

Highly automated processing, highly accurate at low concentrations, low cost

LDI developsPrototype & test

kits

Initial company roadmap

Sell to:- Clinical labs- Research labs Trials;

510(k);Cost: ??

2 years

Research labs partner to

validate product

Sell to:- Point of care- Physician offices CLIA

waiver

1 year

Market size: In-vitro Diagnostics

Worldwide: $44.3B

US: $19B

ID: $4.6B

Source: Kalorama Information (2009)

Oncology: $1.85B

TM: $440M

TM: $2.4B

Out of the building: Customer interviews

RUO labs• Oncologists• Pathologists• Virologists• Sequencing center• Biomolecular eng.• Anal.chemist• MS facility

Regulators

Clinical labs

Partners Water safety

Industry• Stanford MDx• Quest• LabCorp• Idexx

• Test labs• Drug company• Vets• Cancer immuno- therapy• Private oncologist• Pharmaceuticals

• CMS• CAP• CLIA• FDA

• Semiconductor foundry• Assay developers• OEMs• Distributors

• Semiconductor industry• Pool users

Out of the building: Options!

water

chemicals

Service test

Research labs

Clinical labs

Test service (S) vs. Instrument (I) model

Customer Type Preference

UCSF oncologists Academic I

Genentech Industry I

Lab Corp Clinical lab I

Quest Clinical lab I

Idexx Clinical lab I

Stanford oncologists Academic I

Stanford MDx lab Academic I

TBRI (ID) Academic I

UCSF microbiology (ID) Academic I

UCSF virologists (ID) Academic I

• VCs will not fund a hybrid instrument/test company

Clinical Trial Road

Feasibility

ProposalTrial Bid

Trials

Training?

$50k-$1M$3k

Pass?$2k-50k

IRB FDA Submission

X

First MDx cost to approval: $100M, 7 yearsExample:

FDA approval

Aha Moment: Micro-RNA testing

Oncologist: “Micro-RNAs are emerging cancer biomarkers”

Scientist: “Micro-RNAs are not well suited for standard detection.”

Works!

Doesn’t Work

20-30 bases

Successful short-strand detection within 2 weeks!

Impact: • New market segment• New competitive weapon• New value proposition

Validation

Target Market

water

chemicals

Service test

Research labs

Clinical labs

Refined company roadmap

510(k); PMA; $3-100M

5-7 years

RUO:- Researchers- Core labs

Sell to:- Clinical labs- Hospitals

RUO = Research use only

$$$

Source: Web of Science

Market size: Research-use only (RUO)

Worldwide: $27.0B

US: $7.7B Target: $2.3B

Bio

chem

istr

y

Mic

robi

olog

y

Bio

tech

nolo

gy

Onc

olog

y

Vet

erin

ary

Sci

ence

s

Gen

etic

s

Imm

unol

ogy

Infe

ctio

us D

isea

ses

Cel

l Bio

logy

Pla

nt S

cien

ces

0%

2%

4%

6%

8%

10%

12%

14%

RUO Customer Archetypes

Academic research labs Core Diagnostic labs

• principal investigators• large research effort involving nucleic acids/proteins • make purchase decision• heavy instrument users• joint publications

• academic core labs• multi-user-facilities• director or committee decides• multiple instruments• relatively high sample volume• results go back to researchers

Revenue Model: “Razor / razor blade”

Academic research labs

Core Diagnostic labs

Razor - Instrument Blade - Chips and test kits

• loan or lease (~$500/month)• option for discounted purchase

• ~3 options for chip types (~$50/chip)• customized test kits (~$200/kit)

• direct sale (~80k for NATs; ~200k for proteins)

• ~3 options for chip types (~$500/chip)• customized test kits (~$100/kit)

Additional revenue• IP licensing of non-core applications• protein tests for chem/bio researchers (~$200/test)

Chip Manufacturers

RUO Ecosystem

LiquiLume

OEMs

Packaging

Reagents

Shippers

Clinical Labs$$$

Research Labs

$$$

Distributors

$$

$$

Licensing

$$

Doctors

SBIRs

Seed Funding

MVP Production

Customer Validation

Next Steps

Iteratio

n:

On:The Business Model Canvas LiquiLume Diagnostics HS / PM / BD 923 05 2012


Customer Relations

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Research labs

(“RUO”)

2a. Test labs

2b. Hospital labs

- Unprecedented performance

- New biomarker detection (Micro-RNA)

-Perform NAT and protein detection on one platform

- R&D (scientists)

- IP licensing / filing

- Assembly/design

- R&D

- Customer Acquisition

- Distributor cut

- Instrument manufacturing

- Chip fabrication

- IP - Instrument

- Accessories

- Consumables

- Service contracts

- Licensing

- Direct purchase (RUO)

- Trade shows / conferences

- Publications

- Service contracts

- Direct

- On-site support

- Co-develop (research)

- Web forum

Designed for: Designed by:

- MVP- Customers- Partners/advisors- Production - Regulation - SBIRs- Seed investment

Market

- Research labs

- Clinical labs

- Dx co-developers

Product/Operation

- Chip foundry

- Packaging

- OEMs

- Reagent suppliers

- Sample prep.

- Shippers

- Distributors

Canvas Slideshow

- Build viable MVP- Identify and win first customers- Develop partnerships and advisors- Set up production- Assess regulation needs



Customer Relationships

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Cancer researchers

2. Hospital labs

3. Test labs

4. Physicians

5. Pharmaceutical comps

- Early diagnosis, better treatment (docs)- Unprecedented performance [proteins] (docs, researchers)- Lower test cost, faster [NAT] (test labs, hospital labs, payors)- Companion Dx (pharmaceuticals)- Quality of life (patients)

- R&D (scientists)- IP licensing + filing- Chip manufacturing- Assembly/design

- Chip foundry- acad/industr. research labs to validate- distributors- Potential parent comp.- Regulators

- Proteins: Value-driven (unmatched performance)- NATs: Cost-driven (cheaper, faster, simpler)- Economies of scale: increasing # of biomarkers- Economies of scope: both NATs and proteins on one platform- Fixed costs: ongoing R&D; chip fabrication fairly simple

- Instrument: feature-dependent; negotiable; possibly low- Consumables: fixed; mass/volume discounts- Service contracts- Service sales: test per marker per sample


- On-site support- Co-develop (research)- Web forum


Iteration:

Iteration:

- MVP- Customers- Partnerships/advisors- Production - Regulation



Customer Relations

Customer Segments

Channels


Key Resources

1. Research labs

2. Hospital labs

3. Test labs

4. Pharmaceuticals

5. Defense clients

6. Physicians

- Unprecedented performance [proteins] (docs, researchers)- Lower test cost, faster [NAT] (test labs, hospi tal labs, payors)- Drug validation (pharmaceuticals)- PoC on-site diagnosis (military)- Early diagnosis, better treatment (docs)- Quality of life (patients)

- R&D (scientists)

- IP licensing / filing

- Manufacturing

- Assembly/design

- Chip foundry- Research labs- Distributors - Potential parent comp.- Regulators

- Both cost (NAT) and value (proteins) driven

- Economies of scale: biomarker #

- Economies of scope: NATs + proteins

- Fixed costs: ongoing R&D; chip fabrication

- IP

- Instrument

- Consumables

- Service contracts

- Service sales

- Direct purchase

- Distributors

- Website sales

- Trade shows / conf.s

- On-site setup

- Service contracts

- Direct

- On-site support

- Co-develop (research)

- Web forum


Bait and Hook

Iteration:

On:




Customer Relations

Customer Segments

Channels


Key Resources

1. Research labs

2a. Hospital labs

2b. Test labs

4. Pharmaceuticals

5. Defense clients

6. Physicians

- Unprecedented performance [proteins] (docs, researchers)- Lower test cost, faster [NAT] (test labs, hospi tal labs, payors)- Drug validation (pharmaceuticals)- PoC on-site diagnosis (military)- Early diagnosis, better treatment (docs)- Quality of life (patients)

- R&D (scientists)- IP licensing / filing- Manufacturing- Assembly/design

- Chip foundry- Research labs- Distributors - Potential parent comp.

- Both cost (NAT) and value (proteins) driven - Economies of scale: biomarker #- Economies of scope: NATs + proteins- Fixed costs: ongoing R&D; chip fabrication- IP

- Service tests- Instrument- Consumables- Service contracts- Service sales


- Direct- On-site support- Co-develop (research)- Web forum


Bait and Hook

Iteratio

n:

On:




Customer Relations

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Research labs

2a. Hospital labs

2b. Test labs

3. Ultrapure water user (power plant, semi.)

- Unprecedented performance [proteins]

(docs, researchers)- Lower test cost, faster [NAT] (test labs,

hospital labs, payors)

- Cleaner water for ultrapure operations


- Chip foundry- Research labs- Distributors - Potential parent

comp.






Bait and Hook

Iteratio

n:

On:




Customer Relations

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Research labs

2a. Hospital labs

2b. Test labs








comp.



- Direct purchase- Distributors- Website sales- Trade shows / conf.s- FDA clearance- Publications- Service contracts



Bait and Hook

Iteratio

n:

On:




Customer Relations

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Research labs

2a. Hospital labs

2b. Test labs








comp.



- Direct purchase- Trade shows / conf.s- FDA clearance- Publications- Service contracts



Bait and Hook

Iteratio

n:

On:




Customer Relations

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Research labs

2a. Test labs

2b. Hospital labs




-New biomarker detection

-Perform all above on one platform



comp.


- Instrument- Consumables- Service contracts- Service sales

- Direct purchase- Trade shows / conf.s- FDA clearance- Publications- Service contracts



Bait and Hook

Iteratio

n:

On:

- MVP- Customers- Partnerships/advisors- Production - Regulation - SBIRs- Seed investment



Customer Relations

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Research labs (“RUO”)

2a. Test labs

2b. Hospital labs


- New biomarker detection [NAT]

-Perform all above on one platform


- Chip foundry- Packaging- OEMs- Reagent suppliers- Sample prep.- Shippers- Distributors - Dx co-developers- Research labs- Clinical labs

- Both cost (NAT) and value driven - Economies of scale: biomarker #- Economies of scope: NATs + proteins- Fixed costs: ongoing R&D; chip fabrication- IP

- Instrument- Accessories- Consumables- Service contracts

- Direct purchase- Trade shows / conf.s- Publications- Service contracts



Iteratio

n:

On:The Business Model Canvas LiquiLume Diagnostics HS / PM / BD 923 05 2012


Customer Relations

Customer Segments

Channels

Revenue Streams

Cost Structure

Key Resources

1. Research labs (“RUO”)

2a. Test labs

2b. Hospital labs

- Unprecedented performance

- New biomarker detection (Micro-RNA)

-Perform NAT and protein detection on one platform

- R&D (scientists)- IP licensing / filing- Assembly/design

- R&D- Customer Acquisition- Distributor cut- Instrument manufacturing

- Chip fabrication

- IP - Instrument- Accessories- Consumables

- Service contracts

- Licensing

- Direct purchase (RUO)

- Trade shows / conferences

- Publications- Service contracts



- MVP- Customers- Partners/advisors- Production - Regulation - SBIRs- Seed investment

Market- Research labs- Clinical labs- Dx co-developers

Product/Operation- Chip foundry- Packaging- OEMs- Reagent suppliers- Sample prep.- Shippers- Distributors

Backup Slides

Competitors

Nucleic acid tests Protein detection

liquilume nsf final presentation

Education

hospital labs

clinical labs hospitals

researchers core labs

faster nat test labs

years research labs

research use

low cost

test service s