The New England Journal of Medicine. A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer

Transcription

1 The New England Journal of Medicine A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer May 18, 2015

2 Forward-Looking Statements Various remarks that we make on this call that are not historical, including those about: our future financial and operating results; attributes, benefits and value of our tests to patients, physicians and payers; growth opportunities and the size of potential markets; future products, product launches and our product pipeline; execution of our business, commercial and reimbursement strategy; growth in demand for our tests, drivers of demand, and expansion of our customer base; publications, payer coverage, contracts and progress in reimbursement and patient access; our ability to collect from payers for tests performed; impact of the Affordable Care Act and Medicare; and clinical outcomes, timing of clinical studies and physicians use of our tests constitute forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act. We refer you to our Annual Report on Form 10-Q for the quarter ended March 31, 2015, filed with the SEC, and in particular to the section entitled Risk Factors, for additional information on factors that could cause actual results to differ materially from our current expectations. These forward-looking statements speak only as of the date of this call, and we disclaim any obligation to update these forward-looking statements. ***** Veracyte, Afirma, Percepta, the Veracyte logo and Afirma logo are trademarks or registered trademarks of Veracyte, Inc. / 2 / 2015 Veracyte, Inc. All rights reserved.

3 Agenda & Participants Overview: Percepta Bronchial Genomic Classifier Bonnie H. Anderson President & CEO, Veracyte, Inc. The New England Journal of Medicine Publication of AEGIS I & II Avrum Spira, M.D., M.Sc. Professor of Medicine Boston University School of Medicine Questions & Answers Bonnie H. Anderson Avrum Spira, M.D., M.Sc. / 3 / 2015 Veracyte, Inc. All rights reserved.

4 / 4 / 2015 Veracyte, Inc. All rights reserved.

5 Veracyte: Using Molecular Cytology to Resolve Diagnostic Ambiguity Hundreds of thousands of unnecessary, invasive procedures Billions of healthcare dollars wasted ENDOCRINOLOGY PULMONOLOGY Thyroid Cancer (Commercialized) Lung Cancer (Commercialized) Idiopathic Pulmonary Fibrosis (IPF) / 5 / 2015 Veracyte, Inc. All rights reserved.

6 Focused on the Right Point in the Clinical Pathway for Lung Cancer CT Scan Reveals Lung Nodule Intermediate Risk Assessment Bronchoscopy 250,000 per Year Likely Malignant ~100,000 Non-diagnostic Low Risk CT Surveillance in Lieu of Surgery OUR OPPORTUNITY Moderate to High Risk / 6 / 2015 Veracyte, Inc. All rights reserved.

7 Clinical Dilemma Each year in the US, 100,000 bronchoscopies to diagnose lung cancer yield inconclusive results Next steps are not always clear Monitor with CT surveillance? Refer for invasive procedure? The number of bronchoscopies including those where no malignancy is found is expected to increase substantially as lung cancer screening increases / 7 / 2015 Veracyte, Inc. All rights reserved.

8 Avrum Spira, M.D., M.Sc. Professor of Medicine Boston University School of Medicine 8

9 Proprietary Science: Innovative Field of Injury Genomic Technology Peripheral Lung Nodules Are Difficult to Biopsy, Yielding High Rates of Non Diagnostic Bronchoscopies Smoking Alters the Epithelial Cell Gene Expression Throughout the Airway A Gene Signature of a Cytology Sample Collected from the Airway Can Determine Cancer Risk in a Peripheral Lung Nodule (BMC Medical Genomics) Identifying Patients at Low Risk of Cancer Without Surgery or a Sample from the Nodule or Lesion 9

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11 Study Design Current and former smokers undergoing bronchoscopy for suspect lung cancer at 28 medical centers AEGIS I: Feb 27, 2008 to Sept 9, 2011 (n= 298) AEGIS II: Oct 25, 2010, to July 10, 2012 (n=341) A gene expression classifier (Percepta) was measured in epithelial cells collected from the normal appearing mainstem bronchus to assess the probability of lung cancer. Patients were followed until a diagnosis was established or until 12 months after bronchoscopy. 11

12 Performance of Bronchoscopy: recapitulating the unmet need 272/639 patients (43%) had a nondiagnostic bronchoscopy including 120/487 patients (25%) in whom lung cancer was ultimately diagnosed. The sensitivity of bronchoscopy for the detection of lung cancer was 74% in AEGIS I and 76% in AEGIS II. Invasive procedures were performed after a nondiagnostic bronchoscopy in 35% of patients with benign lesions 36% of surgical lung biopsies were performed in patients with benign lesions 12

13 Performance of the bronchial genomic classifier (Percepta TM ) in two prospective cohorts AEGIS I: AUC.78 Sensitivity 88%, Specificity 47% AEGIS II: AUC.74 Sensitivity 89%, Specificity 47% The combination of the classifier plus bronchoscopy increased the sensitivity to 97%, as compared with 75% for bronchoscopy alone 13

14 The bronchial genomic classifier has high sensitivity for detecting lung cancer in the setting of small peripheral lung lesions Silverstri et al. In press 14

15 The classifier has high sensitivity for detecting lung cancer across all cell types and stages of disease 15

16 The classifier has high sensitivity and high negative predictive value among intermediate risk patients where physicians are most uncertain about cancer status 16

17 The Roadmap to Percepta Coverage and Reimbursement On Track for a Successful Product Addressing a specific and compelling unmet clinical need Backed by proprietary and scientific foundation Analytical verification studies complete Two prospective, multi-center and blinded validation studies AEGIS I & II - published in The New England Journal of Medicine Study on Derivation of Percepta published in BMC Medical Genomics Early adoption with top thoughtleaders in pulmonology Key Milestones Going Forward Additional published evidence including clinical utility and costeffectiveness Coverage and reimbursement anticipated in 2016 Broaden access to patients across the United States Meaningful revenue in 2017 / 17 / 2015 Veracyte, Inc. All rights reserved.

18 Building the Pulmonology Franchise Pulmonary Diagnostic Solutions Improving the Diagnosis of Lung Cancer without Surgery Lung Cancer Improving the Diagnosis of IPF without Surgery Interstitial Lung Diseases Presentation of IPF Data on Bronchoscopy Biopsies at ATS 2015 U.S. Launch in / 18 / 2015 Veracyte, Inc. All rights reserved. 1 Estimated

19 CLEAR VALUE: Opportunity to Reduce Invasive Procedures Resulting from Non-Diagnostic Cytology Samples Diagnostic Clarity WITHOUT SURGERY Reduce Surgeries Reduce Time to Diagnosis Reduce Cost to Diagnosis PATIENTS Reduce Unnecessary Surgeries PHYSICIANS Make More Informed Treatment Decisions, Earlier PAYERS Lower Healthcare Costs / 19 / 2015 Veracyte, Inc. All rights reserved.

20 Questions & Answers Bonnie H. Anderson President & CEO Veracyte Inc. Avrum Spira, M.D., M.Sc. Professor of Medicine Boston University School of Medicine / 20 / 2015 Veracyte, Inc. All rights reserved.

21 The New England Journal of Medicine A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer May 18, 2015