UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 5, 2017
MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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0-26642 |
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87-0494517 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
320 Wakara Way
Salt Lake City, Utah 84108
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (801) 584-3600
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On September 5, 2017, Myriad Genetics, Inc. (“Myriad” or the “Company”) held a conference call announcing that it has launched riskScore™, a new clinically validated precision medicine tool to enhance its myRisk® Hereditary Cancer test. A copy of the slide presentation and press release announcing the launch are furnished as Exhibit 99.1 and 99.2 to this Current Report on Form 8-K and incorporated herein by reference. [The slide presentation will also be available under the “Investors –Events & Presentations” section of Myriad’s website at www.myriad.com.]
FORWARD-LOOKING STATEMENTS
Exhibits 99.1 and 99.2 may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our business, goals, strategy and financial and operational outlook. These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in the exhibits is as of the date of the exhibits, and Myriad undertakes no duty to update this information unless required by law.
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(d)
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Exhibit Number |
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Description |
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99.1
99.2 |
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Slide presentation dated September 5, 2017.
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The exhibit(s) may contain hypertext links to information on our website or other parties’ websites. The information on our website and other parties’ websites is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.
In accordance with General Instruction B-2 of Form 8-K, the information set forth in Item 7.01 and in Exhibits 99.1 and 99.2 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MYRIAD GENETICS, INC. |
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Date: September 5, 2017 |
By: |
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/s/ R. Bryan Riggsbee |
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R. Bryan Riggsbee |
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Executive Vice President, Chief Financial Officer |
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Exhibit Number |
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Description |
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99.1
99.2 |
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Slide presentation dated September 5, 2017.
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91% 87% Forward Looking Statements 15M Patient Preventive Care Market 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 results may differ materially and adversely from these expectations. We refer you to the documents the Company files from time to time with the Securities and Exchange Commission, specifically, the Company’s annual reports on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in the Company’s projections or forward-looking statements.
The Fourth Epoch in Hereditary Cancer Testing
CLINICAL UNCERTAINTY Provider and Patient Left Without a Definitive Answer Risk of Breast Cancer 12% Population Risk 87% BRCA Mutation 0% 100%
VS Only 10% of Patients Tested Are From the Largest Pool of Patients That Meet Criteria Doctors Focus on “Neon Light” Patients Due to Challenge of Negative Test Report
personalized medicine tool
riskScore Data Shows Test Highly Impactful & Accurate Proprietary score that combines data from >80 single nucleotide polymorphisms (SNPs) with well documented role in predicting cancer risk along with best-in-class family/personal history model (Tyrer-Cuzick model) Results for unaffected patients with European descent (initially) Provides residual risk for patients that are negative for myRisk test and is complimentary
Advancing Genetic Risk Assessment BRCA1, BRCA2, TP53, STK11 ATM, CHEK2, PALB2, NBN SNPs Frequency Relative Risk Rare variants (high penetrance) Rare variants (moderate penetrance) Common variants (low penetrance) 1 2 5 ≥10
Researched 20 years of genome wide association data on SNPs in breast cancer risk Screened > 100,000 patients to select 24,259 patient training study which identified over 80 highly predictive SNPs 10,575 patient validation study showed the SNP panel in riskScore highly predictive of breast cancer risk Combined genetic markers with family history tool in combined validation in 1,617 patients to be presented at San Antonio Breast Cancer Symposium
Risk Distribution From Combined Risk Score riskScore Data Shows Test Highly Impactful & Accurate Frequency Patients have a broad distribution of relative risk with many significantly above and below the population risk SNP panel was highly statistically significant for lifetime and breast cancer risk with a p-value of 10-31 Combined risk score with SNP panel and Tyrer-Cuzick was highly statistically significant for both lifetime and five-year breast cancer risk with a p-value of 10-34 and 10-38 respectively Risk Population risk
The Report
Patient #1 Patient #2
The Opportunity
91% 9% 87% 13% 0% Would you change medical management based upon the combined score? How would this enhancement impact the competitive advantage of myRisk relative to other panel tests? Market Research Shows High Interest Level in riskScore
91% 87% Physicians Believe riskScore Provides Incremental Value “If it gets marketed to the vast public, then I think Myriad will have a test that nobody else has.” “riskScore adds another piece of the puzzle. The sum of all information adds to an increased risk.“ "This is the most valuable thing a sales rep has shown me in years." “Myriad should be commended for the development of riskScore and advancing the science as it relates to refinement of breast cancer risk.”
91% 87% Provides Reason for Preventive Care Doctors To Go “Deeper” 15M Patient Preventive Care Market From the “trusted advisor” in hereditary cancer Given low positive rate, average preventive care physician only looks for “neon light” patients EVERY patient will now have an individualized assessment of breast cancer risk Improved test value can drive deeper penetration Expands an already significant competitive moat 0.6M Tested Patients
91% 87% Myriad Will Continue to Be a Scientific Pioneer 15M Patient Preventive Care Market Commercially available as of today SNP Panel validation to be presented at National Society of Genetic Counselors annual meeting Combined validation (SNP Panel + Tyrer-Cuzick) presented at San Antonio Breast Cancer Symposium in December Work ongoing to identify breast cancer SNPs for additional ethnicities Future work will expand into other cancers
News Release
Media Contact:Ron RogersInvestor Contact:Scott Gleason
(801) 584-3065(801) 584-1143
rrogers@myriad.comsgleason@myriad.com
Myriad Launches riskScore™ Beginning the Next Epoch in Hereditary Cancer Testing
Provides Individualized Breast Cancer Risk for Patients Testing Negative with the myRisk® Hereditary Cancer Test
SALT LAKE CITY, Utah, September 5, 2017 – Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, announced today that it has launched riskScore™, a new clinically validated precision medicine tool to enhance its myRisk® Hereditary Cancer test. riskScore quantifies a woman’s risk of developing breast cancer by combining genetic markers throughout the genome with her family and clinical history.
“We have known for some time that there are other genetic and clinical factors that can modify a patient’s risk for breast cancer; however, this is the first time that this information has been rigorously validated to guide patient care,” said Mark C. Capone, president and CEO, Myriad Genetics. “As the pioneer in hereditary cancer research, Myriad has been stalwart in our commitment to provide answers to every patient concerned about their breast cancer risks. Through the years Myriad has expanded the number of genes tested and demonstrated an unmatched commitment to classifying uncertain variants. Now this new test will provide definitive answers to the ninety percent of patients testing negative for hereditary cancer genes and will be complimentary to patients tested with myRisk®.”
riskScore is a proprietary algorithm that combines data from greater than 80 genetic markers called single nucleotide polymorphisms (SNPs), with a best-in-class family and personal history algorithm called the the Tyrer-Cuzick model. Myriad researchers optimized the genetic markers in riskScore by starting with over 100,000 patient samples and have now completed two highly statistically significant validation studies in patients of European descent demonstrating the ability of riskScore to predict breast cancer risk. These major validation studies will be presented at the National Society of Genetic Counselors Annual Conference and San Antonio Breast Cancer Symposium later this calendar year.
“Having been the leader in every major epoch in hereditary cancer testing, we feel particularly proud of the innovative research employed to develop the riskScore test,” said Jerry Lanchbury, Ph.D.,
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chief scientific officer, Myriad Genetics. “The test will actually provide definitive answers for a higher percentage of patients than any previous test and is based upon a rigorous clinical validation. When decisions matter, patients can rely on the quality of Myriad research.”
Conference Call and Webcast
Myriad will host an investor conference call today, Tuesday, September 5, 2017, at 4:30 p.m. ET to discuss to discuss the launch of riskScore. The dial-in number for domestic callers is (800) 624-1547. International callers may dial (303) 223-4380. All callers will be asked to reference reservation number 21857299. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.
About riskScore
riskScore is a new clinically validated personalized medicine tool that enhances Myriad’s myRisk® Hereditary Cancer test. riskScore helps to further predict a women’s lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from greater than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was validated in our laboratory to predict breast cancer risk. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk. riskScore is offered free-of-charge as an added service to Myriad’s myRisk Hereditary Cancer test.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five strategic imperatives: stabilizing hereditary cancer revenue, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis
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CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the launch of riskScore, a new clinically validated precision medicine tool to enhance the Company’s myRisk® Hereditary Cancer test; the ability of the riskScore tool to provide definitive answers to the ninety percent of patients testing negative for hereditary cancer genes and being complimentary to patients tested with the myRisk test; the presentation of major validation studies for the riskScore tool at the National Society of Genetic Counselors Annual Conference and San Antonio Breast Cancer Symposium later this calendar year; the ability of the riskScore tool to actually provide definitive answers for a higher percentage of patients than any previous test; patients relying on the quality of Myriad research; the date and time of the conference call and webcast announcing the riskScore tool; and the Company’s strategic directives under the caption “About Myriad Genetics.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory
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terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
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