Myriad Genetics, Inc. · NASDAQ:MYGN
Myriad Genetics — Technical Presentation (January 2019)
30 slides from Myriad Genetics's technical presentation, Jan 4, 2019
Slide 1: Review of GeneSight Supporting Clinical Data
Review of GeneSight® Supporting Clinical Data January 4, 2019 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements Some of the information presented here today may contain projections or other forward-looking statements regarding future events or the future financial performance of the Company. These statements are based on management’s current expectations and the actual events or res
Slide 3: Overview of Clinical Studies in Depression
Overview of Clinical Studies in Depression 3
Slide 4: Overview of Clinical Studies in Depression
Overview of Clinical Studies in Depression Studies typically use subjective patient assessment by questionnaire (HAM D-17 score) as the clinical measure of depressive symptoms Three different endpoints are calculated from changes in these scores: Remission, Response, and Symptom Improvement APA guid
Slide 5: Comparing Improvement in Remission Rates for GeneSight vs. Recent FDA Approved Therapeutics
Comparing Improvement in Remission Rates for GeneSight vs. Most Recent FDA Approved Therapeutics 4 vilazodone1 Viibryd (Khan 2011) vortioxetine2 Trintellix (Jain 2013) vortioxetine3 Trintellix (Jacobsen 2015) GeneSight (Greden 2019) 6.5% p=0.088 -3.1% p=0.443 7.2% p=0.093 5.2% p=0.007 1 – data using
Slide 6: GeneSight Clinical Utility Studies Prior to GUIDED
GeneSight Clinical Utility Studies Prior to GUIDED 5
Slide 7: Multiple Prior Studies Showing Clinical Utility of GeneSight
Multiple Prior Studies Showing Clinical Utility of GeneSight La Crosse Study (n=165) Key Findings: 70% improvement in depressive symptoms (p<0.0001) GeneSight group 2.1x more likely to respond to medication Significantly higher patient satisfaction in the GeneSight arm Pine Rest Study (n=49) Key Fin
Slide 8: Publication Overview GUIDED Study
Publication Overview GUIDED Study 7
Slide 9: Largest Double-Blind RCT of Pharmacogenomics in Mental Health
Largest Double-Blind RCT of Pharmacogenomics in Mental Health Compared ~1,200 patients with MDD who have failed one previous medication receiving GeneSight®-guided therapy to those receiving treatment-as-usual (TAU) 60 study sites including nation’s leading academic institutions Assessed Hamilton De
Slide 10: GeneSight GUIDED Study Schema
n = 2,004 Screening Visit (Eligibility Criteria Evaluated) Did not meet I/C criteria n = 606 n = 1,398 Randomized Screening, Randomization & PGx Testing GeneSight GUIDED Study Schema Study schema and participant enrollment in the peer-protocol cohort Treatment as Usual (TAU) Guided-Care Arm n = 456
Slide 11: GeneSight Test Report is Easy to Use and Understand
GeneSight Test Report is Easy to Use and Understand 12
Slide 12: GUIDED Results Compared to Optimized Active Drug Arm
GUIDED Results Compared to Optimized Active Drug Arm 10
Slide 13: GeneSight-Driven Outcomes are Durable and Improve over Months
GeneSight-Driven Outcomes are Durable and Improve over 6 Months Over 6 months durability Remission doubled during open-label period 11
Slide 14: Change in Red Medication Use by Study Arm
Change in “Red” Medication Use by Study Arm Baseline Week 8 Baseline Week 8 13 Only 57% of patients switched Doctors were naïve to GeneSight Protocol did not require switching Patients blinded to medication TAU physicians did not improve ending with more patients on red medications
Slide 15: Outcomes for Patients Switching From Red Medications
Outcomes for Patients Switching From “Red” Medications 14
Slide 16: Endpoints for ITT Population in Depression Instruments
Endpoints for ITT* Population in 3 Depression Instruments HAM-D17 QIDS-C16 PHQ-9 Response Remission Study arm Study arm Study arm Symptom Improvement p < 0.01 p < 0.01 p = 0.069 p = 0.014 p = 0.285 p = 0.186 p = 0.066 p < 0.01 p = 0.039 ITT = Intent To Treat | HAM-D17 = Hamilton Rating Scale for Dep
Slide 17: Endpoints Highly Statistically Significant When Excluding Green Patients
Endpoints Highly Statistically Significant When Excluding “Green” Patients 16 ITT Population: GeneSight (n=357); TAU (n=429) Excludes 30% patients entering on genetically appropriate medications with no expected GeneSight benefit
Slide 18: Publication Overview IMPACT Study
Publication Overview IMPACT Study 17
Slide 19: IMPACT Study Design
IMPACT Study Design Goal was to compare outcomes of patients with major depressive disorder treated by either psychiatrists or primary care physicians using GeneSight to guide therapy selection Performed in cooperation with the Canadian Centre for Mental Health and Addiction (CAMH) Open label study
Slide 20: IMPACT Study Results
IMPACT Study Results Primary Care Physicians Had Even Better Outcomes Than Psychiatrists Clinical Outcome Primary Care Physicians Psychiatrists % Difference p-Value Remission Rates 19.5% 12.0% 63% <0.01 Response Rates 30.1% 22.3% 35% <0.01 Symptom Improvement 31.7% 24.9% 27% <0.01 19
Slide 21: Publication Overview Health Economic Data
Publication Overview Health Economic Data 20
Slide 22: Medco Prescription Drug Study
Medco Prescription Drug Study Winner JG, et al. Curr Med Res Opin 2015; 18:1-30. (Medco) (n=2168; n=10,880 for TAU group; 5-to-1 match) 12-month review p=0.007 Total medication costs were reduced per patient when treatment was guided by GeneSight GeneSight-guided patients experienced significant inc
Slide 23: Union Health Service Healthcare Utilization Study
Union Health Service Healthcare Utilization Study Red-bin patients had >4-fold more disability claims (p = 0.013) >20 workplace absence days (p = 0.024), compared to green- (p = 0.04) or yellow-bin (p = 0.1) patients Compared to green- or yellow-bin patients, red-bin patients had 67% more general me
Slide 24: Positive ROI with GeneSight
Positive ROI with GeneSight $1,036 Drug Spend Savings1 $1,556 Healthcare Savings2 $3,367 Potential Savings Annually + = + UP TO $775 Productivity Savings2 Payer Employer Winner JG, et al. Curr Med Res Opin 2015; 31(9):1633-43. (Medco) (n=2168; n=10,880 for TAU group; 5-to-1 match) Winner JG, et al.
Slide 25: Optum Health Study Design
Optum Health Study Design Provided costs and budget impact associated with GeneSight Psychotropic testing for major commercial health plan Utilized claims from Single Payer Database compiled by OptumInsight, Inc. comprising approximately 25 million members nationwide Compared members with GeneSight-
Slide 26: Optum Health Study Results
Optum Health Study Results GeneSight TAU Savings All Patients $17,627 $23,132 $5,505 (p=0.0004) Patients With MDD $18,741 $24,971 $6,050 (p=0.009) >$6,000 in total 12-month savings for patients with MDD Savings do not include productivity improvements 37% 13% 50% 25
Slide 27: HEDIS Scores Another Motivation For Payers With GeneSight
HEDIS Scores Another Motivation For Payers With GeneSight Healthcare Effectiveness Data and Information Set (HEDIS) is a comprehensive set of standardized performance measures designed to provide purchasers and consumers with the information they need for reliable comparison of health plan performan
Slide 28: Conclusion & Next Steps
Conclusion & Next Steps éxgenesight wi
Slide 29: Key Takeaways From Clinical Studies
Key Takeaways From Clinical Studies The GUIDED study is the fifth favorable clinical study and the first blinded, prospective study GeneSight led to a 50% increase in remission rates, 30% increase in response rates, and 11% improvement in symptoms with remission and response achieving statistical si
Slide 30: Next Steps
Next Steps 29 Begin the tech assessment process with major national payers and request out-of-cycle reviews where appropriate File formal reconsideration request with Medicare to expand LCD to primary care physicians Continue to publish numerous additional GUIDED studies with key opinion leaders Pur
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