nvta investor deck 040116 jbs21.q4cdn.com/.../2016/nvta-investor-deck-040116.pdf · 2016-04-05 ·...

© 2016 Invitae Corporation. All Rights Reserved. 1

INVITAE:Bringing genetic information into mainstream medical practiceO VERVI EW FO R I NVESTO RSAPRI L 2 0 1 6


Safe Harbor Statement

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company’s expectations regarding its plans for 2016, including revenue levels, the cost of goods sold, the number of billable tests delivered, the number of genes in its test menu, and the nature and extent of future reimbursement coverage; the company’s expectations regarding continued growth in 2016; and the timing of any new testing service releases and the benefits and attributes of any such services. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company’s history of losses; the company’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company’s ability to develop and commercialize new tests and expand into new markets; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; the company’s ability to compete; laws and regulations applicable to the company’s business, including potential regulation by the Food and Drug Administration; and theother risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in thecompany’s Annual Report on Form 10-K for the year ended December 31, 2015. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

NOTE: Invitae and the Invitae logo are trademarks of Invitae Corporation. All other trademarks and service marks are the property of their respective owners.


Genetic information has the

global opportunity to affect

billions of people


Invitae’s story:Bringing a new era of genome-centric healthcareto billions of peopleEveryone has a unique genome that has a significant impact on their health

There are over 4,000 medically important genetic tests today –most of which are over-priced and under-utilized

High quality, low pricedgenetic testing will dramatically increase the total market to everyone with access to healthcare


~2-5%1 in 20 to 1 in 50 healthy people has a gene mutation that puts them at risk for a medically actionable condition

~0.5-5%1 in 20 to 1 in 200 people carry the Factor V Leiden variant that may increase risk for blood clotting

~5-10%1 in 20 to 1 in 10 of all cancers are likely to have a hereditary basis

Genetic conditions affect everyone

“Rare” genetic conditions are actually common in the aggregate

1 in 250 people has a gene mutation that may lead to early onset cardiovascular disease

0.4%

~2%1 in 50 new births result in a complication involving a genetic condition

0.3%1 in 300 will have an epileptic seizure during their lifetime

~100%

Everyone is carrying mutations that can cause severe illness in a child if the child’s other parent provides a mutation in the same gene

~100% Virtually everyone is carrying mutations affecting drug response

Everyone carries mutations in their genome that cause disease, affect drug responseor recessive genetic conditions that may affect their families


Unknown

Limited

LowComplexity of Diagnosis

High

Num

ber o

f Gen

es In

volv

ed

Exomes/Genomes

Large gene panels

Small gene panels

Single Gene Testing

Variant testing

Sickle-cell anemia

High risk breast cancer

Hypertrophic cardiomyopathy

Diagnostic Odyssey

BRCA1

Historically, genetic testing was limited by cost


Exomes/Genomes

Large gene panels

Small gene panels

Single Gene Testing

Variant testing

Invitae offers one price per indication regardless of the number of genes

Increasing number of genes

Cost

Cost of the first gene

Cost of increasing genes

Technology is improving quality and creating economy of scale

Invitae is changing the cost structure of the industry


Genetic testing is a multi-billion dollar industry today

§ 55,208 different genetic assays currently available across 4,489 disorders and 5,328 genes (GeneTests.org, January 7, 2016)

§ Over 673 laboratories and 1,068 clinics(GeneTests.org, January 7, 2016)

§ Quality and content is variable

§ Prices can reach into the thousands of dollars and even tens of thousands for complex tests

§ Turn around times can often be months or more

Invitae provides a new world of high quality, low cost genetic testing

High Cost

VariableQuality

§ Comprehensive content across all disease areas

§ High quality peer-reviewed science

§ One-stop online ordering for any and every high quality genetic test

§ Fast turn around times

§ Open and transparent pricing below $1,000for patients and contracted payers withfull reimbursement support

…but it’s highly fragmented, inefficient, and prohibitively expensive


Invitae is well positioned for growth in 2016 and 2017

Bring comprehensive genetic information into mainstream medical practice to improvethe quality of healthcare for billions of people

Our Mission Our Goal

Aggregate all the world’s genetic tests into a single platform to make genetics affordable and accessiblefor everyone

Adult symptomatic Pediatric genetics Health & wellness2015 2016 2017


Only genetic testing laboratory to aggregate the world’s genetic tests into a high quality, affordable offering

§ Recently expanded beyond cancer and cardiology with metabolic disorders/newborn screening, neurology, and pediatric/rare diseases

§ Now has more than 1,000 genes in production for less than $1,000 –achieved milestone a year early through R&D acceleration


Invitae has demonstrated the quality of our service

A Systematic Comparison of Traditional andMultigene Panel Testing for Hereditary Breast andOvarian Cancer Genes in More Than 1000 PatientsStephen E. Lincoln,* Yuya Kobayashi,* Michael J. Anderson,* Shan Yang,* Andrea J. Desmond,y Meredith A. Mills,z

Geoffrey B. Nilsen,* Kevin B. Jacobs,* Federico A. Monzon,* Allison W.Q35 Kurian,z James M. Ford,z and Leif W. Ellisenyx

Q2 From the Invitae,* San Francisco, California; the Massachusetts General Hospital Cancer Center,y Boston, Massachusetts; the Stanford University School ofMedicine,z Stanford, California; and the Harvard Medical School,x Boston, Massachusetts

Accepted for publicationApril 28, 2015.

Address correspondence toStephen E. Lincoln, Invitae,458Q5 Brannan St, San Francisco,CA 94107. E-mail: [email protected].

Gene panels for hereditary breast and ovarian cancer risk assessment are gaining acceptance, eventhough the clinical utility of these panels is not yet fully defined. Technical questions remain,however, about the performance and clinical interpretation of gene panels in comparison withtraditional tests. We tested 1105 individuals using a 29-gene next-generation sequencing panel andobserved 100% analytical concordance with traditional and reference data on >750 comparablevariants. These 750 variants included technically challenging classes of sequence and copy numbervariation that together represent a significant fraction (13.4%) of the pathogenic variantsobserved. For BRCA1 and BRCA2, we also compared variant interpretations in traditional reports tothose produced using only non-proprietary resources and following criteria based on recent (2015)guidelines. We observed 99.8% net report concordance, albeit with a slightly higher variant ofuncertain significance rate. In 4.5% of BRCA-negative cases, we uncovered pathogenic variants inother genes, which appear clinically relevant. Previously unseen variants requiring interpretationaccumulated rapidly, even after 1000 individuals had been tested. We conclude that next-generation sequencing panel testing can provide results highly comparable to traditional testingand can uncover potentially actionable findings that may be otherwise missed. Challenges remainfor the broad adoption of panel tests, some of which will be addressed by the accumulation of largepublic databases of annotated clinical variants. (J Mol Diagn 2015, -: 1e12; http://dx.doi.org/10.1016/j.jmoldx.2015.04.009)

MultigeneQ6 panel testing has proved useful as a diagnostic toolfor disorders where similar phenotypes can be influenced bymultiple genes.1 Recent advances in next-generation DNAsequencing technology (NGS) have enabled these clinical testsand made them increasingly inexpensive to perform.2,3 Forhereditary cancer syndromes, studies have shown that NGS-based panel tests can uncover potentially actionable findingsthat may be missed by traditional testing paradigms.4e12 Vali-dation studies of clinical NGS assays for hereditary cancergenes have correspondingly been published,4,7,11,13,14 andcertain guidelines exist for their clinical implementation.15e18

Patient management experience using these hereditary cancerpanels is growing,4,19,20 although the clinical utility of these

Supported by The Friends Fighting Breast Cancer Q3, the Tracey DavisMemorial Fund, and the Q4Breast Cancer Research Foundation.

Disclosures: The funding organizations had no role in the design,conduct, or reporting of this study. Invitae provided the 29-gene panel testresults used in this study. This study was an academic collaboration and nota sponsored research project: no other funding or compensation was pro-vided by Invitae. S.E.L., Y.K., M.J.A., S.Y., G.B.N., and F.A.M. are em-ployees of Invitae and own stock and/or stock options. J.M.F. is a paidmember of Invitae’s advisory board. Separately from this study, J.M.F. andA.W.K. receive research funding from Myriad Genetics. L.W.E. is aconsultant to Bioreference/GeneDx Laboratories. S.E.L. owns stock inIllumina, whose instruments were used in this study.

This paper conforms to the STARD guidelines (http://www.stard-statement.org) for reporting of diagnostic cohort studies.

Current address of K.B.J., 23andMe, Inc., Mountain View, CA.

Copyright ª 2015 American Society for Investigative Pathologyand the Association for Molecular Pathology.Published by Elsevier Inc. All rights reserved.http://dx.doi.org/10.1016/j.jmoldx.2015.04.009

jmd.amjpathol.org

The Journal of Molecular Diagnostics, Vol. -, No. -, - 2015

1234567891011121314151617181920212223242526272829303132333435363738394041424344454647484950515253545556575859606162

63646566676869707172737475767778798081828384858687888990919293949596979899100101102103104105106107108109110111112113114115116117118119120121122123124

FLA 5.2.0 DTD ! JMDI426_proof ! 22 July 2015 ! 1:34 am ! EO: JMD14_0252

~1,000 patient study head-to-head with Myriad

Analytical validity for BRCA testingAnalytical Concordance – 100%

Clinical validity for BRCA testingClinical Concordance – 99.8%

Demonstrated clinical utility beyond BRCA for hereditary cancer panels based on NCCN guidelines

>1,000 patient study demonstrating clinical utility


Invitae offers high quality at lower prices

Cost of out-of-network denials and appeals

Patient pay$475

Contracted Price$950*

List Price$1,500

*Contracted price is as low as $950 per indication depending on administrative criteria

§ One price per indication regardless the number of genes§ Re-requisition at no additional charge within 90 days in original indication§ Patient pay alternative for those who do not meet insurance criteria

Depends on administrative criteria

Upfront payment


21st century approach to medical genetics

§ One laboratory process§ One-stop online ordering§ One low price per indication

Hereditary Cancer SyndromesWorld-class

Talent

GreatTechnology

Great Automation

Peer-reviewed Science

Economy of Scale

Hereditary Neurological Conditions

Hereditary Cardiac Conditions


Foundational year: demonstrated scalability and growth

201520142013

>19,000 billable reports

>3,600 billable reports

229 billable reports

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4Q1 Q2 Q3 Q4

Lessons learned from 2015§ Content, quality and affordability drive volume

§ Small, targeted sales force effective in reaching genetics providers

Increasedcontent anddecreased

prices

Tripledour

content

Sales reps: 1 2 3 6 10 14 16 210


Measuring our success in 2015

Reducing COGSenables us to release

more content

More content (genes) enables us to drive

more volume

More volume enablesus to accelerate reimbursement

Reimbursement enables us to reinvest inreducing COGS



2015 COGS per sample

>200genes

>600genes

2015 Content on assays2015 Revenue

Q1

$1.2MQ2

$1.6MQ3

$2.2M

2015 Volume by Billable Reports

Q1

2,200

Q2

4,100 Q4

7,000

Q3

5,500

Q4

$3.2M

Q1

$1,250

Q2

$850

Q3

$750

Q4

$700



2015 COGS per sample

>200genes

>600genes

2015 Content on assays

2015 Volume by Billable Reports

Q1

2,200

Q2

4,100 Q4

7,000

Q3

5,500

Q1

$1,250

Q2

$850

Q3

$750

Q4

$700

2015 Reimbursement Contracts

§ 41 Institutional contracts§ Blue Shield of CA§ BCBS Association § Tufts Health Plan

§ OSU Health Plan§ SelectHealth§ Others



COGS

Content

Volume

Reimbursement


Accelerating menu releases

Driving down COGS


Medicare andtop major private insurers

in network>200genes

>600genes

>3,000genes

Q4:2016

< $500Q4:2014

$1,500

Q4:2015

$700

Billable reports delivered

3.6Kreports

19Kreports

50K-70K reports

2016

20152014

20152013

2016


~2-5%1 in 20 to 1 in 50 healthy people has a gene mutation that puts them at risk for a medically actionable condition

~0.5-5%1 in 20 to 1 in 200 people carry the Factor V Leiden variant that may increase risk for blood clotting

~5-10%1 in 20 to 1 in 10 of all cancers are likely to have a hereditary basis



1 in 250 people has a gene mutation that may lead to early onset cardiovascular disease

0.4%

~2%1 in 50 new births result in a complication involving a genetic condition

0.3%1 in 300 will have an epileptic seizure during their lifetime

~100%

Everyone is carrying mutations that can cause severe illness in a child if the child’s other parent provides a mutation in the same gene

~100% Virtually everyone is carrying mutations affecting drug response


✓

✓

✓

✓

✓


0.3%

~0.5-5%

~2-5%Evaluating risk for medically actionable disorders inhealthy adults

~5-10%



0.4%

~2%

~100%Testing genes for recessive variants in individuals interested in pre-conception and family risk assessment

~100% Testing specific genetic variants linked to drug efficacy


Expanding menu by the end of 2016

✓

✓

✓

✓

✓

✓

✓

✓


Genetic TestingMake genetic testing more affordable and more accessible than ever before

Genome ManagementBuild a genome management infrastructure

Genome NetworkShare genetic information on a global scale to advance healthcare and clinical outcomes

High volume marketfor genetic testingwith focus on qualityand price

Genomics will create value over the lifetime of a customer

Monetizing networks for permission-based sharing of genetic information

The three phases of our business model


Invitae is piloting health and wellness in 2016

Simple facts about the size of our healthcare economy where preventive genetics could help

1 billion Doctor visitsper year

50 million Surgeriesper year

1.6 million New cancersper year

Heart attacksper year1.5 million

4 million Birthsper year

3 millionNew disablingneurologicaldisorders per year

1 million First time parentsper year

4 billion Prescriptions writtenper year


Invitae will pilot its adult prevention panel in H1 2016

Genetic Testing


Invitae will draw fromthe most common, actionable genetic

content on its menuto create a world-class,

medically relevantadult panel for

health and wellness

Testing genes for recessive variants in individuals interested in pre-conception and family risk assessment

Testing specific genetic variants linked to drug efficacy

Evaluating risk for medically actionable disorders in healthy adults

H1 2016

H2 2016

H2 2016

Expanded test menu fuels 2016 Genome Managementand Genome Network milestones



Genetic Testing

Genome Management


Utilize our expanded content to launch our first health and wellness program, the adult prevention panel

GenomeNetwork

Launch participatory research study networks:

§ Adult preventionresearch network

§ Oncology research network

§ Cardiology research network

Expanded test menu fuels 2016 Genome Managementand Genome Network milestones


Patients own and control their own genetic information

STORE Simply store your genetic information

LEARN Understand more about your genome

SHARE Family members, physician, networks, no-one

PARTICIPATE Research, development, clinical trials, marketing

DONATE Medical research, genomic philanthropy

MEDICAL CONDITION

MEDICATIONS

HAVING KIDS

INJURIES OR SURGERIES

HEALTH ISSUES

AGING GRACEFULLY

NEONATAL

Genome Management

Clinical diagnostics

PGx screening

Carrier testing

Bleeding disorder screening

Focused clinical trials

Preventative health

Newborn screening

Invitae’s vision: building a customer for life

Genomics-informed medicine over the course of a patient’s lifetime


Billable tests

2014-2015 revenue ($k)

$118 $301 $310$876

$1,200 $1,800

$2,200

$3,200

Q1:2014 Q2:2014 Q3:2014 Q4:2014 Q1:2015 Q2:2015 Q3:2015 Q4:2015

200 500 1,100 1,800 2,200 4,400 5,100

7,000

Q1:2014 Q2:2014 Q3:2014 Q4:2014 Q1:2015 Q2:2015 Q3:2015 Q4:2015

§ Expenses are incurredfor tests in the periodin which the test is conducted

§ Balance sheet cashand cash equivalents of $131.8M as ofDecember 31,2015

§ Note: billable test numbers and revenues are approximate

Financial summary


Expand content

Improve customer

experience

Drive Volume

Attract Partners

Growth

Lowercosts

Lower prices

Invitae’s flywheel for future growth

nvta investor deck 040116 jbs21.q4cdn.com/.../2016/nvta-investor-deck-040116.pdf · 2016-04-05 ·...

Documents