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NVTA Overview for Investors April 2016
1.
© 2016 Invitae
Corporation. All Rights Reserved. 1 INVITAE: Bringing genetic information into mainstream medical practice O VERVI EW FO R I NVESTO RS APRI L 2016
2.
© 2016 Invitae
Corporation. All Rights Reserved. 2 Safe Harbor Statement This presentationcontains forward-looking statements within the meaning of thePrivate Securities LitigationReform Act of 1995, including statements relating to thecompany’s expectations regarding its plans for 2016, including revenuelevels, the cost of goods sold, the number of billable tests delivered, the number of genes in its test menu, and thenature andextent of future reimbursement coverage; the company’s expectations regardingcontinued growth in 2016; and thetiming 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 couldcause actual results to differ materially, andreportedresults shouldnot 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 advanceof demand for its tests and to increasedemandfor its tests; the company’s ability to develop and commercialize new tests andexpand intonew 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 datato interprettest results accurately and consistently; the company’s ability to compete; laws and regulations applicable to the company’s business, including potential regulationby the Food and Drug Administration; andthe other risks set forth in the company’s filings with the Securities and Exchange Commission, includingthe risks set forth in the company’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-lookingstatements. NOTE: Invitae and the Invitaelogo are trademarks of Invitae Corporation. All other trademarks andservice marks are the property of their respective owners.
3.
© 2016 Invitae
Corporation. All Rights Reserved. 3 Genetic information has the global opportunity to affect billions of people
4.
© 2016 Invitae
Corporation. All Rights Reserved. 4 Invitae’s story: Bringing a new era of genome-centric healthcare to billions of people Everyone 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 priced genetic testing will dramatically increase the total market to everyone with access to healthcare
5.
© 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 affectingdrug response Everyone carries mutations in their genome that cause disease, affect drug response or recessive genetic conditions that may affect their families
6.
© 2016 Invitae
Corporation. All Rights Reserved. 6 Unknown Limited Low Complexity of Diagnosis High NumberofGenesInvolved 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
7.
© 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
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© 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 Variable Quality § 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 $1,000 for patients and contracted payers with full reimbursement support …but it’s highly fragmented, inefficient, and prohibitively expensive
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© 2016 Invitae
Corporation. All Rights Reserved. 9 Invitae is well positionedfor growth in 2016 and 2017 Bring comprehensive genetic information into mainstream medical practice to improve the 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 accessible for everyone Adult symptomatic Pediatric genetics Health & wellness 2015 2016 2017
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© 2016 Invitae
Corporation. All Rights Reserved. 10 Only genetic testing laboratoryto aggregate the world’s genetic tests into a high quality, affordableoffering § 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
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© 2016 Invitae
Corporation. All Rights Reserved. 11 Invitae has demonstrated the quality of our service A Systematic Comparison of Traditional and Multigene Panel Testing for Hereditary Breast and Ovarian Cancer Genes in More Than 1000 Patients Stephen 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 of Medicine,z Stanford, California; and the Harvard Medical School,x Boston, Massachusetts Accepted for publication April 28, 2015. Address correspondence to Stephen E. Lincoln, Invitae, 458Q5 Brannan St, San Francisco, CA 94107. E-mail: steve. lincoln@invitae.com. Gene panels for hereditary breast and ovarian cancer risk assessment are gaining acceptance, even though 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 with traditional tests. We tested 1105 individuals using a 29-gene next-generation sequencing panel and observed 100% analytical concordance with traditional and reference data on >750 comparable variants. These 750 variants included technically challenging classes of sequence and copy number variation that together represent a significant fraction (13.4%) of the pathogenic variants observed. For BRCA1 and BRCA2, we also compared variant interpretations in traditional reports to those 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 of uncertain significance rate. In 4.5% of BRCA-negative cases, we uncovered pathogenic variants in other genes, which appear clinically relevant. Previously unseen variants requiring interpretation accumulated rapidly, even after 1000 individuals had been tested. We conclude that next- generation sequencing panel testing can provide results highly comparable to traditional testing and can uncover potentially actionable findings that may be otherwise missed. Challenges remain for the broad adoption of panel tests, some of which will be addressed by the accumulation of large public 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 tool for disorders where similar phenotypes can be influenced by multiple genes.1 Recent advances in next-generation DNA sequencing technology (NGS) have enabled these clinical tests and made them increasingly inexpensive to perform.2,3 For hereditary cancer syndromes, studies have shown that NGS- based panel tests can uncover potentially actionable findings that may be missed by traditional testing paradigms.4e12 Vali- dation studies of clinical NGS assays for hereditary cancer genes have correspondingly been published,4,7,11,13,14 and certain guidelines exist for their clinical implementation.15e18 Patient management experience using these hereditary cancer panels is growing,4,19,20 although the clinical utility of these Supported by The Friends Fighting Breast Cancer Q3, the Tracey Davis Memorial 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 test results used in this study. This study was an academic collaboration and not a 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 paid member of Invitae’s advisory board. Separately from this study, J.M.F. and A.W.K. receive research funding from Myriad Genetics. L.W.E. is a consultant to Bioreference/GeneDx Laboratories. S.E.L. owns stock in Illumina, 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 Pathology and 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 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 FLA 5.2.0 DTD Š JMDI426_proof Š 22 July 2015 Š 1:34 am Š EO: JMD14_0252 ~1,000 patient study head-to-head with Myriad Analytical validity for BRCA testing Analytical Concordance – 100% Clinical validity for BRCA testing Clinical Concordance – 99.8% Demonstrated clinical utility beyond BRCA for hereditary cancer panels based on NCCN guidelines >1,000 patient study demonstrating clinical utility
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© 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
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© 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 Syndromes World-class Talent Great Technology Great Automation Peer-reviewed Science Economy of Scale Hereditary Neurological Conditions Hereditary Cardiac Conditions
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© 2016 Invitae
Corporation. All Rights Reserved. 14 Foundational year: demonstrated scalabilityand growth 201520142013 >19,000 billablereports >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 Increased content and decreased prices Tripled our content Sales reps: 1 2 3 6 10 14 16 210
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© 2016 Invitae
Corporation. All Rights Reserved. 15 Measuring our success in 2015 Reducing COGS enables us to release more content More content (genes) enables us to drive more volume More volume enables us to accelerate reimbursement Reimbursement enables us to reinvest in reducing COGS
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© 2016 Invitae
Corporation. All Rights Reserved. 16 Measuring our success in 2015 2015 COGS per sample >200 genes >600 genes 2015 Content on assays2015 Revenue Q1 $1.2M Q2 $1.6M Q3 $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
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© 2016 Invitae
Corporation. All Rights Reserved. 17 Measuring our success in 2015 2015 COGS per sample >200 genes >600 genes 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
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© 2016 Invitae
Corporation. All Rights Reserved. 18 Measuring our success in 2016 COGS Content Volume Reimbursement
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© 2016 Invitae
Corporation. All Rights Reserved. 19 Accelerating menu releases Driving down COGS Measuring our success in 2016 Medicare and top major private insurers in network >200 genes >600 genes >3,000 genes Q4:2016 < $ 500Q4:2014 $1,500 Q4:2015 $700 Billable reports delivered 3.6K reports 19K reports 50K-70K reports 2016 2015 2014 20152013 2016
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© 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 affectingdrug response Everyone carries mutations in their genome that cause disease, affect drug response or recessive genetic conditions that may affect their families ✓ ✓ ✓ ✓ ✓
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© 2016 Invitae
Corporation. All Rights Reserved. 21 0.3% ~0.5-5% ~2-5% Evaluating risk for medically actionable disorders in healthy 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 response or recessive genetic conditions that may affect their families Expanding menu by the end of 2016 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
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© 2016 Invitae
Corporation. All Rights Reserved. 22 Genetic Testing Make genetic testing more affordable and more accessible than ever before Genome Management Build a genome management infrastructure Genome Network Share genetic information on a global scale to advance healthcare and clinical outcomes High volume market for genetic testing with focus on quality and 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
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© 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 visits per year 50 million Surgeries per year 1.6 million New cancers per year Heart attacks per year1.5 million 4 million Births per year 3 million New disabling neurological disorders per year 1 million First time parents per year 4 billion Prescriptions written per year
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© 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 from the most common, actionable genetic content on its menu to create a world-class, medically relevant adult 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 Management and Genome Network milestones
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© 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 Genome Network Launch participatory research study networks: § Adult prevention research network § Oncology research network § Cardiology research network Expanded test menu fuels 2016 Genome Management and Genome Network milestones
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© 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
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© 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 incurred for tests in the period in which the test is conducted § Balance sheet cash and cash equivalents of $131.8M as of December 31,2015 § Note: billable test numbers and revenues are approximate Financial summary
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© 2016 Invitae
Corporation. All Rights Reserved. 28 Expand content Improve customer experience Drive Volume Attract Partners Growth Lower costs Lower prices Invitae’s flywheel for future growth
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