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): November 7, 2017
MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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0-26642 |
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87-0494517 |
(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):
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
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 November 7, 2017, Myriad Genetics, Inc. (“Myriad”) announced its financial results for the three months ended September 30, 2017. The earnings release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
ITEM 7.01 |
Regulation FD Disclosure. |
On its earnings conference call for the three months ended September 30, 2017, Myriad also delivered a slide presentation, which is attached hereto as Exhibit 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 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.
Page 2
(d)
Exhibit Number |
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Description |
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99.1 |
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Earnings release dated November 7, 2017 for the three months ended September 30, 2017. |
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99.2 |
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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 2.02 and 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.
Page 3
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: November 7, 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 |
Page 4
Exhibit 99.1
News Release
Media Contact:Ron RogersInvestor Contact:Scott Gleason
(801) 584-3065(801) 584-1143
rrogers@myriad.comsgleason@myriad.com
Myriad Genetics Reports Fiscal First-Quarter 2018 Financial Results
• |
Total Revenues of $190.2 Million Up 7 Percent |
• |
GAAP Diluted EPS of $1.15 and Adjusted EPS of $0.26 Up 13 Percent |
• |
GeneSight® Demonstrates Statistical Significance for Response and Remission in Prospective Study |
SALT LAKE CITY, Nov. 7, 2017 – Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and personalized medicine, today announced financial results for its fiscal first-quarter 2018, provided an update on recent business highlights, maintained its fiscal year 2018 financial guidance, and issued fiscal second-quarter 2018 financial guidance.
"The first quarter exceeded our expectations and represented an excellent start to the fiscal year as a result of strong hereditary cancer and GeneSight® test demand,” said Mark C. Capone, president and CEO, Myriad Genetics. “Perhaps more importantly we had a number of significant reimbursement catalysts that strengthen our ability to deliver on our long-term financial goals.”
Financial Highlights
The following table summarizes the financial results for the fiscal first-quarter 2018:
2
Revenue |
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Fiscal First-Quarter |
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($ in millions) |
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2018 |
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2017 |
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% Change |
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Molecular diagnostic testing revenue |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Hereditary cancer testing revenue |
$ |
126.7 |
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$ |
139.3 |
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(9%) |
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|
|
|
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GeneSight testing revenue |
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28.8 |
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7.2 |
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300% |
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|
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|
|
|
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Vectra DA testing revenue |
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16.0 |
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11.6 |
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38% |
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|
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Prolaris testing revenue |
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2.9 |
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2.9 |
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0% |
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|
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|
|
|
|
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EndoPredict testing revenue |
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1.9 |
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1.7 |
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12% |
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Other testing revenue |
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2.5 |
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2.4 |
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4% |
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Total molecular diagnostic testing revenue |
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178.8 |
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165.1 |
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8% |
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|
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|
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Pharmaceutical and clinical service revenue |
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11.4 |
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12.4 |
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(8%) |
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|
|
|
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|
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Total Revenue |
$ |
190.2 |
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$ |
177.5 |
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7% |
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Income Statement |
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Fiscal First-Quarter |
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($ in millions) |
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2018 |
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2017 |
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% Change |
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Total Revenue |
$ |
190.2 |
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$ |
177.5 |
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7% |
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Gross Profit |
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147.2 |
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137.5 |
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7% |
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Gross Margin |
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77.4% |
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77.5% |
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Operating Expenses |
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59.8 |
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131.8 |
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(55%) |
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Operating Income |
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87.4 |
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5.7 |
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1433% |
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Operating Margin |
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46.0% |
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3.2% |
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Adjusted Operating Income |
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24.7 |
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21.6 |
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14% |
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Adjusted Operating Margin |
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13.0% |
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12.2% |
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|
|
|
|
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Net Income |
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81.1 |
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(1.2) |
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NM |
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Diluted EPS |
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1.15 |
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(0.02) |
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NM |
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Adjusted EPS |
$ |
0.26 |
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$ |
0.23 |
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13% |
3
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• |
Hereditary Cancer |
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o |
Exceeded three percent hereditary cancer volume target in the first quarter, and achieved the third straight quarter of volume growth with pricing in-line with expectations. |
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o |
Launched riskScore™, a new clinically validated personalized medicine tool to enhance the 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 and represents a major new epoch in hereditary cancer testing. |
|
o |
Presented data at the National Society of Genetic Counselors demonstrating that in a cohort of 17,205 women, the riskScore single nucleotide polymorphism (SNP) panel was highly predictive of breast cancer risk with a p- value of less than 10-50. |
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o |
The National Comprehensive Cancer Network (NCCN) updated their professional guidelines to include a recommendation that all metastatic prostate cancer patients receive hereditary cancer testing. There are approximately 26,000 men in the United States every year who develop metastatic prostate cancer. |
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• |
GeneSight |
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o |
Achieved statistically significant improvement in the gold-standard outcomes of response and remission in 1,200 patient prospective randomized controlled trial. |
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o |
Presented data from the IMPACT study at the World Congress of Psychiatric Genetics demonstrating that GeneSight statistically significantly improved anxiety symptom severity in 210 patients with generalized anxiety disorder. Anxiety symptoms based on the GAD-7 scale, improved 45 percent in patients receiving congruent therapy versus 26 percent for patients receiving non-congruent therapy. The result was statistically significant with a p-value of 0.03. |
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o |
Presented MEDCO health economic data showing patients with generalized anxiety disorder who used GeneSight saved on average $6,747 in prescription costs with congruent versus non-congruent therapy selection. |
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• |
Vectra DA |
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o |
Presented data at the American College of Rheumatology (ACR) meeting demonstrating that Vectra DA® was four times better at predicting radiographic progression compared to DAS28 and other conventional measures of disease activity. |
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o |
Presented new clinical utility data from 60,596 patients demonstrating that physicians use Vectra DA scores to change treatment decisions appropriately. The study found that |
4
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in patients who were naive to biologics, rheumatologists were 118 percent more likely to recommend a biologic for patients with a high Vectra DA score when compared to patients with a low Vectra DA score. For patients already on a biologic, rheumatologists were 158 percent more likely to change therapy on patients with high Vectra DA scores compared to those with low Vectra DA scores. |
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o |
Signed coverage with evidence development agreement with CareFirst BlueCross BlueShield, the 18th largest commercial payer in the United States. |
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• |
EndoPredict |
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o |
Presented new data at the World Congress on Controversies in Breast Cancer. In a study of 387 women determined to be at intermediate risk by the Nottingham Prognostic Index, EndoPredict markedly outperformed the first generation test with two times the prognostic power. Additionally, in this patient cohort EndoPredict was the only test that was statistically significant for predicting late stage recurrence (5-10 years). |
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• |
Companion Diagnostics |
|
o |
Submitted a supplemental PMA for BRACAnalysis® CDx in conjunction with AstraZeneca’s Lynparza submission for HER2- metastatic breast cancer with approval expected in the fiscal third quarter. |
|
o |
UnitedHealthcare recently updated its hereditary breast and ovarian cancer coverage policy to include coverage for all metastatic breast cancer patients based upon the need to evaluate these patients for PARP inhibitor therapy. |
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• |
International |
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o |
Signed the company’s first payer demonstration study with GeneSight in Canada with Sun Life Financial, the largest private health insurer in Canada. The study will evaluate the ability of GeneSight to improve both clinical and health economic outcomes in patients with anxiety and depression. |
|
o |
Submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for use in HER2- metastatic breast cancer patients. |
Fiscal Year 2018 and Fiscal Second-Quarter 2018 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2018 and fiscal second-quarter 2018 financial guidance:
5
Revenue |
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GAAP Diluted Earnings Per Share |
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Adjusted Earnings Per Share |
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Fiscal Year 2018 |
$750-$770 million |
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$1.41-$1.46 |
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$1.00-$1.05 |
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Fiscal Second-Quarter 2018 |
$187-$189 million |
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$0.08-$0.10 |
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$0.22-$0.24 |
These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today to discuss the fiscal first-quarter financial results, fiscal year 2018 financial guidance, and fiscal second-quarter 2018 financial guidance.
Conference Call and Webcast
A conference call will be held today, Tuesday, November 7, 2017, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-701-6414. International callers may dial 1-303-223-4376. All callers will be asked to reference reservation number 21859999. 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 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 CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore and Prolaris are trademarks or registered
6
trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS (Unaudited)
(in millions, except per share amounts)
|
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Three months ended |
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|||||
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September 30, |
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|||||
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2017 |
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2016 |
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Molecular diagnostic testing |
|
$ |
178.8 |
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$ |
165.1 |
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Pharmaceutical and clinical services |
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|
11.4 |
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12.4 |
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Total revenue |
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190.2 |
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|
|
177.5 |
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Costs and expenses: |
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|
|
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|
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Cost of molecular diagnostic testing |
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36.2 |
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|
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34.3 |
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Cost of pharmaceutical and clinical services |
|
|
6.8 |
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|
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5.7 |
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Research and development expense |
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|
17.8 |
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|
|
19.4 |
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Change in the fair value of contingent consideration |
|
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(73.2 |
) |
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0.5 |
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Selling, general, and administrative expense |
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115.2 |
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|
|
111.9 |
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Total costs and expenses |
|
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102.8 |
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171.8 |
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Operating income |
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87.4 |
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5.7 |
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Other income (expense): |
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Interest income |
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|
0.4 |
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|
|
0.3 |
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Interest expense |
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(0.9 |
) |
|
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(0.7 |
) |
Other |
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(0.3 |
) |
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(1.3 |
) |
Total other income (expense): |
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(0.8 |
) |
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(1.7 |
) |
Income before income tax |
|
|
86.6 |
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4.0 |
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Income tax provision |
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5.6 |
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|
5.2 |
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Net income (loss) |
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$ |
81.0 |
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$ |
(1.2 |
) |
Net loss attributable to non-controlling interest |
|
|
(0.1 |
) |
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— |
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Net income (loss) attributable to Myriad Genetics, Inc. stockholders |
|
$ |
81.1 |
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|
$ |
(1.2 |
) |
Earnings per share: |
|
|
|
|
|
|
|
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Basic |
|
$ |
1.18 |
|
|
$ |
(0.02 |
) |
Diluted |
|
$ |
1.15 |
|
|
$ |
(0.02 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
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Basic |
|
|
68.6 |
|
|
|
68.8 |
|
Diluted |
|
|
70.4 |
|
|
|
68.8 |
|
7
Consolidated Balance Sheets (Unaudited)
(in millions)
|
|
Quarters Ended September 30, |
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|||||
|
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2017 |
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2016 |
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ASSETS |
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Current assets: |
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|
|
|
|
|
|
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Cash and cash equivalents |
|
$ |
87.9 |
|
|
$ |
102.4 |
|
Marketable investment securities |
|
|
60.4 |
|
|
|
48.3 |
|
Prepaid expenses |
|
|
9.5 |
|
|
|
12.7 |
|
Inventory |
|
|
38.9 |
|
|
|
42.2 |
|
Trade accounts receivable, less allowance for doubtful accounts of $8.6 September 30, 2017 and $8.2 June 30, 2017 |
|
|
113.2 |
|
|
|
105.6 |
|
Prepaid taxes |
|
|
8.8 |
|
|
|
0.2 |
|
Other receivables |
|
|
6.9 |
|
|
|
5.7 |
|
Total current assets |
|
|
325.6 |
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|
|
317.1 |
|
Property, plant and equipment, net |
|
|
49.8 |
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|
|
51.1 |
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Long-term marketable investment securities |
|
|
50.1 |
|
|
|
48.5 |
|
Intangibles, net |
|
|
483.8 |
|
|
|
491.6 |
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Goodwill |
|
|
319.0 |
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|
|
316.1 |
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Total assets |
|
$ |
1,228.3 |
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|
$ |
1,224.4 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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|
|
|
|
|
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Accounts payable |
|
$ |
22.5 |
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|
$ |
22.0 |
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Accrued liabilities |
|
|
59.8 |
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|
|
65.6 |
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Short-term contingent consideration |
|
|
54.0 |
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|
|
127.3 |
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Deferred revenue |
|
|
2.9 |
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|
|
2.6 |
|
Total current liabilities |
|
|
139.2 |
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|
|
217.5 |
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Unrecognized tax benefits |
|
|
31.9 |
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|
25.2 |
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Other long-term liabilities |
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|
7.4 |
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|
|
7.2 |
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Contingent consideration |
|
|
13.8 |
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|
13.2 |
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Long-term debt |
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|
74 |
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|
99 |
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Long-term deferred taxes |
|
|
91.2 |
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|
|
84.4 |
|
Total liabilities |
|
|
357.7 |
|
|
|
446.6 |
|
Commitments and contingencies |
|
|
|
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Stockholders’ equity: |
|
|
|
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Common stock, 69.2 and 68.4 shares outstanding at September 30, 2017 and June 30, 2017 respectively |
|
|
0.7 |
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|
|
0.7 |
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Additional paid-in capital |
|
|
859.6 |
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|
|
851.4 |
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Accumulated other comprehensive loss |
|
|
(2.2 |
) |
|
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(5.5 |
) |
Retained earnings (deficit) |
|
|
12.8 |
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|
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(68.4 |
) |
Total Myriad Genetics, Inc. stockholders’ equity |
|
|
870.9 |
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|
|
778.2 |
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Non-Controlling Interest |
|
|
(0.3 |
) |
|
|
(0.4 |
) |
Total stockholders' equity |
|
|
870.6 |
|
|
|
777.8 |
|
Total liabilities and stockholders’ equity |
|
$ |
1,228.3 |
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|
$ |
1,224.4 |
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8
Consolidated Statement of Cash Flows (Unaudited)
(in millions)
|
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September 30, |
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|||||
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|
2017 |
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|
2016 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net Income (loss) attributable to Myriad Genetics, Inc. stockholders |
|
$ |
81.1 |
|
|
|
(1.2 |
) |
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
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Depreciation and amortization |
|
|
13.2 |
|
|
|
9.2 |
|
Non-cash interest expense |
|
|
0.1 |
|
|
|
0.1 |
|
Gain on disposition of assets |
|
|
(0.1 |
) |
|
|
(0.2 |
) |
Share-based compensation expense |
|
|
6.4 |
|
|
|
7.8 |
|
Bad debt expense |
|
|
8.0 |
|
|
|
7.2 |
|
Deferred income taxes |
|
|
4.7 |
|
|
|
3.2 |
|
Unrecognized tax benefits |
|
|
6.7 |
|
|
|
0.4 |
|
Change in fair value of contingent consideration |
|
|
(73.2 |
) |
|
|
0.5 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
3.2 |
|
|
|
7.8 |
|
Trade accounts receivable |
|
|
(16.5 |
) |
|
|
(5.9 |
) |
Other receivables |
|
|
0.3 |
|
|
|
(1.8 |
) |
Inventory |
|
|
3.3 |
|
|
|
(13.0 |
) |
Prepaid taxes |
|
|
(8.9 |
) |
|
|
(1.0 |
) |
Accounts payable |
|
|
0.4 |
|
|
|
(5.0 |
) |
Accrued liabilities |
|
|
(5.8 |
) |
|
|
(10.0 |
) |
Deferred revenue |
|
|
0.6 |
|
|
|
(1.0 |
) |
Net cash provided by (used in) operating activities |
|
|
23.5 |
|
|
|
(2.9 |
) |
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(1.6 |
) |
|
|
(1.5 |
) |
Acquisitions, net of cash acquired |
|
|
— |
|
|
|
(213.0 |
) |
Purchases of marketable investment securities |
|
|
(31.5 |
) |
|
|
(32.2 |
) |
Proceeds from maturities and sales of marketable investment securities |
|
|
17.9 |
|
|
|
88.7 |
|
Net cash used in investing activities |
|
|
(15.2 |
) |
|
|
(158.0 |
) |
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net proceeds (payments) from common stock issued under share-based compensation plans |
|
|
1.7 |
|
|
|
(1.9 |
) |
Net proceeds from issuance of debt |
|
|
— |
|
|
|
199.0 |
|
Repayment of revolving credit facility |
|
|
(25.0 |
) |
|
|
— |
|
Repurchase and retirement of common stock |
|
|
— |
|
|
|
(21.3 |
) |
Net cash provided by (used in) financing activities |
|
|
(23.3 |
) |
|
|
175.8 |
|
Effect of foreign exchange rates on cash and cash equivalents |
|
|
0.5 |
|
|
|
3.5 |
|
Net increase (decrease) in cash and cash equivalents |
|
|
(14.5 |
) |
|
|
18.4 |
|
Cash and cash equivalents at beginning of the period |
|
|
102.4 |
|
|
|
68.5 |
|
Cash and cash equivalents at end of the period |
|
$ |
87.9 |
|
|
$ |
86.9 |
|
9
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company’s hereditary cancer business representing a major new epoch in hereditary cancer testing; the Company’s expectation that riskScore will enhance the myRisk Hereditary Cancer test; broadening payor coverage and delivering on the Company’s long-term financial goals; the Company’s expectation that a supplemental PMA for BRACAnalysis CDx in conjunction with AstraZeneca’s Lynparza submission for HER2- metastatic breast cancer will be approved in the fiscal third quarter; the National Comprehensive Cancer Network (NCCN) updating their professional guidelines to include a recommendation that all metastatic prostate cancer patients receive hereditary cancer testing; UnitedHealthcare updating its hereditary breast and ovarian cancer coverage policy to include coverage for all metastatic breast cancer patients based upon the need to evaluate these patients for PARP inhibitor therapy; the Company’s second-quarter revenue guidance of $187 to $189 million, adjusted earnings per share of $0.22 to $0.24, and diluted earnings per share guidance of $0.08 to $0.10, and the Company’s reiterated fiscal full year revenue guidance of total revenue of $750 to $770 million, diluted earnings per share guidance of $0.37 to $0.42, and adjusted earnings per share guidance of $1.00 to $1.05, as further discussed under the caption “Fiscal Year 2018 and Fiscal Second-Quarter 2018 Financial Guidance”; 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 the Company’s existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to the Company’s ability to transition from its existing product portfolio to the Company’s new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for the Company’s tests or the Company’s ability to obtain reimbursement for its new tests at comparable levels to its existing tests; risks related to increased competition and the development of new competing tests and services; the risk that the Company 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 the Company may not successfully develop new markets for its molecular diagnostic tests and pharmaceutical and clinical services, including the Company’s ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying the Company’s 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
10
delays or other problems with operating the Company’s laboratory testing facilities; risks related to public concern over the Company’s genetic testing in general or the Company’s 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 the Company’s ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to the Company’s ability to successfully integrate and derive benefits from any technologies or businesses that it licenses or acquires, including but not limited to the Company’s acquisition of Assurex, Sividon and the Clinic; risks related to the Company’s projections about the potential market opportunity for the Company’s products; the risk that the Company or its licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying the Company’s tests; the risk of patent-infringement claims or challenges to the validity of the Company’s patents; risks related to changes in intellectual property laws covering the Company’s 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 the Company may be unable to comply with financial operating covenants under the Company’s credit or lending agreements; the risk that the Company will be unable to pay, when due, amounts due under the Company’s credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in the Company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
Statement regarding use of non-GAAP financial measures
In this press release, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. Management believes that presentation of operating results using non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached schedules.
Following is a description of the adjustments made to GAAP financial measures:
11
|
• |
Acquisition - amortization of intangible assets: Represents recurring amortization charges resulting from the acquisition of intangible assets, including developed technology and database rights. |
|
• |
Acquisition – integration related costs: Costs related to closing and integration of acquired companies |
|
• |
Tax impact related to equity compensation – Changes in effective tax rate based upon ASU 2016-09 |
|
• |
Tax expense associated with R&D tax credit reserves – One time net benefits associated with the release of R&D tax credit reserves. |
|
• |
Potential future consideration related to acquisitions – Non-cash expenses related to valuation adjustments of earn-out and milestone payments tied to recent acquisitions |
|
• |
One-time non-deductible costs – One-time non-deductible tax items |
|
• |
Elevate 2020 costs –Expenses tied to Elevate 2020 program |
The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.
12
Reconciliation of GAAP to Non-GAAP Financial Measures
for the Three Months ended September 30, 2017 and 2016
(Unaudited data in millions, except per share amount
|
|
Three Months Ended |
|
|||||
|
|
Sep 30, 2017 |
|
|
Sep 30, 2016 |
|
||
Revenue |
|
$ |
190.2 |
|
|
$ |
177.5 |
|
|
|
|
|
|
|
|
|
|
GAAP Cost of molecular diagnostic testing |
|
$ |
36.2 |
|
|
$ |
34.3 |
|
GAAP Cost of pharmaceutical and clinical services |
|
|
6.8 |
|
|
|
5.7 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
— |
|
Non-GAAP COGS |
|
$ |
43.0 |
|
|
$ |
40.0 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP Gross Margin |
|
|
77 |
% |
|
|
77 |
% |
|
|
|
|
|
|
|
|
|
GAAP Research and Development |
|
$ |
17.8 |
|
|
$ |
19.4 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
(0.1 |
) |
Acquisition - amortization of intangible assets |
|
|
(0.1 |
) |
|
|
(0.1 |
) |
Elevate 2020 costs |
|
|
(0.1 |
) |
|
|
— |
|
Non-GAAP R&D |
|
$ |
17.6 |
|
|
$ |
19.2 |
|
|
|
|
|
|
|
|
|
|
GAAP Contingent Consideration |
|
$ |
(73.2 |
) |
|
$ |
0.5 |
|
Potential future consideration related to acquisitions |
|
|
73.2 |
|
|
|
(0.5 |
) |
Non-GAAP Contingent Consideration |
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
GAAP Selling, General and Administrative |
|
$ |
115.2 |
|
|
$ |
111.9 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
(9.9 |
) |
Acquisition - amortization of intangible assets |
|
|
(9.1 |
) |
|
|
(5.3 |
) |
Elevate 2020 costs |
|
|
(1.2 |
) |
|
|
— |
|
Non-GAAP SG&A |
|
$ |
104.9 |
|
|
$ |
96.7 |
|
|
|
|
|
|
|
|
|
|
GAAP Operating Income (Loss) |
|
$ |
87.4 |
|
|
$ |
5.7 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
10.0 |
|
Acquisition - amortization of intangible assets |
|
|
9.2 |
|
|
|
5.4 |
|
Elevate 2020 costs |
|
|
1.3 |
|
|
|
— |
|
Potential future consideration related to acquisitions |
|
|
(73.2 |
) |
|
|
0.5 |
|
Non-GAAP Operating Income |
|
$ |
24.7 |
|
|
$ |
21.6 |
|
Non-GAAP Operating Margin |
|
|
13 |
% |
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
GAAP Net Loss Attributable to Myriad Genetics, Inc. Stockholders |
|
$ |
81.1 |
|
|
|
(1.2 |
) |
Acquisition - Integration related costs |
|
|
— |
|
|
|
10.0 |
|
Acquisition - amortization of intangible assets |
|
|
9.2 |
|
|
|
5.4 |
|
Elevate 2020 costs |
|
|
1.3 |
|
|
|
— |
|
Tax impact related to equity compensation |
|
|
0.3 |
|
|
|
2.4 |
|
Potential future consideration related to acquisitions |
|
|
(73.2 |
) |
|
|
0.5 |
|
One-time non-deductible costs |
|
|
— |
|
|
|
2.8 |
|
Tax effect associated with non-GAAP adjustments |
|
|
(0.5 |
) |
|
|
(3.9 |
) |
Non-GAAP Net Income |
|
$ |
18.2 |
|
|
$ |
16.0 |
|
|
|
|
|
|
|
|
|
|
GAAP Diluted EPS |
|
$ |
1.15 |
|
|
$ |
(0.02 |
) |
Non-GAAP Diluted EPS |
|
$ |
0.26 |
|
|
$ |
0.23 |
|
|
|
|
|
|
|
|
|
|
Diluted shares outstanding |
|
|
70.4 |
|
|
|
69.5 |
|
13
(Unaudited data in millions)
|
|
Three Months Ended |
|
|||||
|
|
Sep 30, 2017 |
|
|
Sep 30, 216 |
|
||
GAAP cash flow from operations |
|
$ |
23.5 |
|
|
$ |
(2.9 |
) |
Capital expenditures |
|
|
(1.6 |
) |
|
|
(1.5 |
) |
Free cash flow |
|
$ |
21.9 |
|
|
$ |
(4.4 |
) |
Elevate 2020 costs |
|
|
1.3 |
|
|
|
— |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
7.9 |
|
Cash paid at closing to Assurex vendors |
|
|
— |
|
|
|
6.8 |
|
Tax effect associated with non-GAAP adjustments |
|
|
(0.5 |
) |
|
|
(5.7 |
) |
Non-GAAP Free cash flow |
|
$ |
22.7 |
|
|
$ |
4.6 |
|
Reconciliation of GAAP to Non-GAAP for Fiscal Year 2018 and Fiscal Second-Quarter 2018 Financial Guidance
The Company’s future performance and financial results are subject to risks and uncertainties, and actual results could differ materially from guidance set forth below. Some of the factors that could affect the Company’s financial results are stated in the safe harbor statement of this press release. More information on potential factors that could affect the Company’s financial results are included under the heading "Risk Factors" contained in Item 1A in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in the Company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
|
|
Fiscal Year 2018 |
Diluted net income per share |
|
|
GAAP diluted net income per share |
$1.41 - $1.46 |
|
Acquisition - amortization of intangible assets |
0.53 |
|
Change in contingent consideration |
(1.04) |
|
One-time expenses |
|
0.10 |
Non-GAAP diluted net income per share |
$1.00 - $1.05 |
|
|
|
|
|
|
|
|
|
Fiscal Second-Quarter 2018 |
Diluted net income per share |
|
|
GAAP diluted net income per share |
$0.08 - $0.10 |
|
Acquisition - amortization of intangible assets |
0.12 |
|
One-time expenses |
|
0.02 |
Non-GAAP diluted net income per share |
$0.22- $0.24 |
Myriad Genetics Fiscal First-Quarter 2018 Earnings Call 11/07/2017 Exhibit 99.2
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 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. In this presentation, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. The Company’s financial measures under GAAP include substantial one-time charges related to its acquisitions and ongoing amortization expense related to acquired intangible assets that will be recognized over the useful lives of the assets and charges related to executive severance. Management believes that presentation of operating results that excludes these items provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A link to reconciliation of the GAAP to non-GAAP financial guidance is provided above. Forward Looking Statements Non-GAAP Financial Measures Fiscal Year 2018 GAAP diluted earnings per share $1.41 - $1.46 Acquisition – amortization of intangible assets $0.53 Change in contingent consideration ($1.04) One time charges $0.10 Non-GAAP diluted earnings per share $1.00 - $1.05 Fiscal Second-Quarter 2018 GAAP diluted earnings per share $0.08 - $0.10 Acquisition – amortization of intangible assets $0.12 One time charges $0.02 Non-GAAP diluted earnings per share $0.22 - $0.24 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/
FY2018 First-Quarter Financial Results Significantly Exceeded Expectations 1Q18 Actual Results 1Q17 Actual Results YoY Change Guidance Revenue (in mil.) $190.2 $177.5 7% $181 - $183 GAAP EPS $1.15 ($0.02) NM $0.05 - $0.07 Adjusted EPS $0.26 $0.23 13% $0.19 - $0.21
Critical Success Factors to Achieve Strategic Goals Stabilize hereditary cancer revenue Grow new product volume STRATEGIC GOALS CRITICAL SUCCESS FACTORS >10% Revenue Growth >30% Operating Margin 7 Products >$50M >10% International Revenue Expand reimbursement for new products Increase international RNA kit revenue Improve profitability with Elevate 2020
Stabilize Hereditary Cancer Revenue Continued Strong Volume Growth and Stable Pricing Outlook VOLUME Exceeded 3% volume growth target in 1Q18 3rd straight quarter with YoY volume growth Launched riskScore™ which broadens competitive moat and could deepen market penetration PRICING In line with expectations 3% U.S. Oncology & ION Customizable Panels Digital Integration riskScore™ Competitor Quality Concerns Key Drivers of Volume Trends
Grow New Product Volume Double-Digit New Product Volume Growth in Fiscal Year 1Q18 New products comprise ≈70% of test volume Adjusted new product volume grew at double-digit rate year-over-year* EndoPredict reaches 2% market share in U.S. Double-digit YoY Growth ≈30% ≈70% *includes full quarterly GeneSight volume from 1Q17
Expand Reimbursement Coverage for New Products Significant Progress Towards Broader Coverage Current U.S. Reimbursement GeneSight showed statistically significant improvement in response and remission in MDD Medicare begins reimbursement for Prolaris favorable intermediate patients Signed Vectra DA Coverage with Evidence Development (CED) agreement with CareFirst Vectra DA now has demonstration study agreements with 5 of the top 20 payers
Increase Revenue Internationally Two Key Events in 1H18 Canada: Launched first GeneSight demonstration study with Sun Life Financial which covers 20% of Canadian population Canadian Market opportunity = 1,000,000 treatment resistant depression patients per year Japan: Submitted BRACAnalysis CDx for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to Lynparza for use in HER2- metastatic breast cancer patients Market opportunity = >10,000 patients per year
Improve Profitability With Elevate 2020 Significant Sequential Reduction in Adjusted Operating Expenses $129.6 $121.9 $7.7M sequential decline
Fiscal First-Quarter 2018 Revenue By Product Increased 7% Over Q1 FY2017 Product 1Q18 1Q17 YoY Growth Hereditary Cancer $126.7 $139.3 (9%) GeneSight $28.8 $7.2 300% Vectra DA $16.0 $11.6 38% Prolaris $2.9 $2.9 0% EndoPredict $1.9 $1.7 12% Other $2.5 $2.4 4% Total Molecular Diagnostic Revenue $178.8 $165.1 8% Pharmaceutical & Clinical Services $11.4 $12.4 (8%) Total Revenue $190.2 $177.5 7% (in millions)
Fiscal First-Quarter Financial Results Adjusted EPS Increased 13% Over Q1 FY2017 (in millions except per share data) 1Q18 1Q17 YoY Growth Total Revenue $190.2 $177.5 7% Gross Profit $147.2 $137.5 7% Gross Margin 77.4% 77.5% -10 BP Operating Income $87.4 $5.7 1433% Adjusted Operating Income $24.7 $21.6 14% Adjusted Operating Margin 13.0% 12.2% +80 BP Net Income $81.1 ($1.2) NM Diluted EPS $1.15 ($0.02) NM Adjusted EPS $0.26 $0.23 13%
FY18 and 2Q18 Financial Guidance Maintaining Fiscal Year 2018 Guidance Metric Fiscal Year 2018 Fiscal Second-Quarter 2018 Revenue $750 to $770 million $187 to $189 million GAAP Diluted EPS $1.41 to $1.46 $0.08 to $0.10 Adjusted EPS $1.00 to $1.05 $0.22 to $0.24 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/
Potential Catalysts in Fiscal Year 2018 Multiple Possibilities for Material Upsides Potential Catalyst Potential Timing Opportunity Annualized Revenue Impact Annualized EPS Impact Hereditary Cancer Better Volume Growth FY18 6% Growth 9% Growth $15M $30M $0.12 $0.24 BRACAnalysis CDx Metastatic Breast Cancer Indication 2H FY18 10% Penetration 30% Penetration $25M $75M $0.19 $0.57 GeneSight Additional Reimbursement FY18 Top Commercial Payer 3 Top 10 Payers $40M $60M $0.36 $0.54 Vectra DA ACR Guidelines & Reimbursement 2H FY18 Top Commercial Payer 3 Top 10 Payers $6M $9M $0.05 $0.08 Prolaris Additional Reimbursement FY18 Top Commercial Payer 3 Top 10 Payers $3M $5M $0.03 $0.05 EndoPredict Increased Adoption in U.S. FY18 5% market penetration $12M $0.09 myPath Melanoma Additional Reimbursement FY18 Medicare Coverage $2M $0.02
riskScore Represents New Epoch in Hereditary Cancer Further Widens Already Substantial Competitive Moat Before After 100% of patients get a definitive answer 100% of patients get a definitive answer 10% of patients get a definitive answer
GeneSight RCT Achieves Gold Standard Outcomes Highly Statistically Significant Improvement in Response & Remission Rates Statistically significant improvement in gold-standard outcomes of response and remission at eight weeks Improvement in HAMD-17 scores at eight weeks approached statistical significance Continued improvement in remission rates, response rates, and symptoms through 24 months demonstrating durability of benefit Full data set released at APA annual meeting in May Study endpoint What it Measures Study Result Importance to Clinicians and Payers Remission - hardest to achieve Patient no longer depressed Highly statistically significant (p<0.01) Very important Response - difficult to achieve Patient feels a lot better Highly statistically significant (p=0.01) Very important Symptom Improvement - most likely to achieve Patient feels somewhat better Approaching statistical significance (p=0.1) Meaningful
Two Most Critical Endpoints are Response and Remission Influential Guidelines Emphasize Getting “Well” and not just “Better” Professional Guideline Statement American Psychiatric Association (APA) Depression Guidelines “The overall goals of treatment of major depressive disorder should focus on alleviating functional impairments and improving quality of life in addition to achieving symptom resolution and episode remission.” American College of Neuropsychopharmacology (ACNP) Consensus Statement “Treatments with a greater likelihood of attaining remission, a more rapid onset of remission, or a higher probability of sustaining remission have clear therapeutic advantages, given the implications of remission for function and prognosis.”
IMPACT Study Validates the Use of GeneSight in GAD Leads to Statistically Significant Better Outcomes GeneSight guided group had statistically significant reduction in GAD-7 scores 25% reduction in benzodiazepine use in patients receiving congruent therapy Net cost savings of $6,747 per patient from the MEDCO study 60 million people in U.S. have GAD; larger market than depression * Combinatorial Pharmacogenomic Testing Improves Generalized Anxiety Disorder Treatment Response and Decreases Benzodiazapine use
Vectra DA Outperforms Conventional Measures of Disease Activity 3x Better at Predicting Radiographic Progression Relative Risk of Radiographic Progression (High Versus Low Scores) n = 748 (p=0.23) (p=0.01) (p<0.0001) [1] LEIDEN: van der Helm-van Mil et al. Rheumatology (Oxford). 2013;53:839–846. [2] OPERA: Brahe et al. Arthritis Rheumatol. ACR 2016 Abstract 2520. [3] SWEFOT Year 1: Hambardzumyan K, et al. Ann Rheum Dis. 2015;74:1102–9. [4] SWEFOT Year 2: Hambardzumyan K et al. RMD Open. 2016 Mar 1;2(1):e000197. [5] Curtis et al. Arthritis Rheumatol. 2016 Nov 3. doi: 10.1002/art.39981 and Fleischmann et al. Arthritis Rheumatol. 2016 Dec 19. DOI: 10.1002/art.40021. 3x as Predictive as DAS28-CRP [1]-[5]
Vectra DA Again Outperforms Conventional Disease Activity Measures 4x Better at Predicting Radiographic Progression Radiographic Progression Likelihood Ratio* 4x as Predictive as DAS28 (p=0.079) (p=0.049) (p=0.04) (p=0.032) (p=3.6x10-4) n = 1,411 *F-Statistic [1] Curtis et al. Arthritis Rheumatology (2017;69 [1]
New 60,596 Patient Clinical Utility Study on Vectra DA Doctors Appropriately Modify Treatment Decisions Based Upon the Vectra DA Score (p<0.0001) (p<0.0001) Proportion of Patients That Changed Therapy Low (<30) Moderate (30-44) High (>44) 2.2x 2.6x
EndoPredict Outperforms Oncotype Dx® in Second Study EndoPredict Has >2x The Prognostic Power and Predicts Late Stage Metastases Prognostic Performance 0-10 Years Prognostic Performance 5-10 Years *Comparison of prognostic performance of Oncotype Dx RS versus EndoPredict in women with intermediate risk of recurrence by Nottingham Prognostic Index Oncotype Dx is a registered trademark of Genomic Health Inc. Likelihood Ratio x2
Submitted Supplemental PMA for HER2- Metastatic BrCa Expect Approval in 3Q18; Untested Population Represents 125,000 Women Diagnosed with or progress to metastatic disease HER2+ 40,000 HER2- 60,000 155,000 Two-thirds not currently eligible for hereditary cancer testing Don’t progress to metastatic disease 255,000 cases of invasive breast cancer
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