© 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
© 2016 Invitae Corporation. All Rights Reserved. 2
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.
© 2016 Invitae Corporation. All Rights Reserved. 3
Genetic information has the
global opportunity to affect
billions of people
© 2016 Invitae Corporation. All Rights Reserved. 4
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
© 2016 Invitae Corporation. All Rights Reserved. 5
~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
© 2016 Invitae Corporation. All Rights Reserved. 6
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
© 2016 Invitae Corporation. All Rights Reserved. 7
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
© 2016 Invitae Corporation. All Rights Reserved. 8
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
© 2016 Invitae Corporation. All Rights Reserved. 9
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
© 2016 Invitae Corporation. All Rights Reserved. 10
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
© 2016 Invitae Corporation. All Rights Reserved. 11
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
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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
© 2016 Invitae Corporation. All Rights Reserved. 12
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
© 2016 Invitae Corporation. All Rights Reserved. 13
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
© 2016 Invitae Corporation. All Rights Reserved. 14
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
© 2016 Invitae Corporation. All Rights Reserved. 15
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
© 2016 Invitae Corporation. All Rights Reserved. 16
Measuring our success in 2015
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
© 2016 Invitae Corporation. All Rights Reserved. 17
Measuring our success in 2015
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
© 2016 Invitae Corporation. All Rights Reserved. 18
Measuring our success in 2016
COGS
Content
Volume
Reimbursement
© 2016 Invitae Corporation. All Rights Reserved. 19
Accelerating menu releases
Driving down COGS
Measuring our success in 2016
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
© 2016 Invitae Corporation. All Rights Reserved. 20
~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
✓
✓
✓
✓
✓
© 2016 Invitae Corporation. All Rights Reserved. 21
0.3%
~0.5-5%
~2-5%Evaluating risk for medically actionable disorders inhealthy adults
~5-10%
Genetic conditions affect everyone
“Rare” genetic conditions are actually common in the aggregate
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
Everyone carries mutations in their genome that cause disease, affect drug responseor recessive genetic conditions that may affect their families
Expanding menu by the end of 2016
✓
✓
✓
✓
✓
✓
✓
✓
© 2016 Invitae Corporation. All Rights Reserved. 22
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
© 2016 Invitae Corporation. All Rights Reserved. 23
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
© 2016 Invitae Corporation. All Rights Reserved. 24
Invitae will pilot its adult prevention panel in H1 2016
Genetic Testing
Invitae will pilot its adult prevention panel in H1 2016
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
© 2016 Invitae Corporation. All Rights Reserved. 25
Invitae will pilot its adult prevention panel in H1 2016
Genetic Testing
Genome Management
Invitae will pilot its adult prevention panel in H1 2016
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
© 2016 Invitae Corporation. All Rights Reserved. 26
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
© 2016 Invitae Corporation. All Rights Reserved. 27
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
© 2016 Invitae Corporation. All Rights Reserved. 28
Expand content
Improve customer
experience
Drive Volume
Attract Partners
Growth
Lowercosts
Lower prices
Invitae’s flywheel for future growth