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): February 6, 2018
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 February 6, 2018, Myriad Genetics, Inc. (“Myriad”) announced its financial results for the three and six months ended December 31, 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 and six months ended December 31, 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 February 6, 2018 for the three and six months ended December 31, 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: February 6, 2018 |
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
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News Release |
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Media Contact: |
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Ron Rogers |
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Investor Contact: |
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Scott Gleason |
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(801) 584-3065 |
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(801) 584-1143 |
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rrogers@myriad.com |
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sgleason@myriad.com |
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Myriad Genetics Reports Fiscal Second-Quarter 2018 Financial Results
• |
Total Revenues of $194.0 Million |
• |
GAAP Diluted EPS of $0.45 and Adjusted EPS of $0.31 Up 19 Percent |
• |
Company Raises Financial Guidance for Fiscal Year 2018 |
SALT LAKE CITY, Feb. 6, 2018 – Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and personalized medicine, today announced financial results for its fiscal second-quarter 2018, provided an update on recent business highlights, raised its fiscal year 2018 financial guidance, and issued fiscal third-quarter 2018 financial guidance.
"We exceeded our financial expectations in the first half of fiscal year 2018 as a result of strong hereditary cancer volume trends, solid GeneSight® revenue growth, and significant progress on our Elevate 2020 profitability program,” said Mark C. Capone, president and CEO, Myriad Genetics. “Based upon this strong performance we are increasing our financial guidance for fiscal 2018. We remain highly encouraged that our strategy to build upon the solid foundation of our hereditary cancer business with diversified revenues from our industry-leading pipeline of new products will deliver significant future revenue and earnings growth.”
2
The following table summarizes the financial results for the fiscal second-quarter 2018:
Revenue |
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Fiscal Second-Quarter |
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($ 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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Hereditary cancer testing revenue |
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$ |
126.9 |
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$ |
143.9 |
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(12 |
%) |
GeneSight testing revenue |
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31.7 |
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21.7 |
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46 |
% |
Vectra DA testing revenue |
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11.1 |
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10.7 |
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4 |
% |
Prolaris testing revenue |
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5.0 |
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3.1 |
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61 |
% |
EndoPredict testing revenue |
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2.0 |
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1.6 |
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25 |
% |
Other testing revenue |
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2.5 |
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2.9 |
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(14 |
%) |
Total molecular diagnostic testing revenue |
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179.2 |
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183.9 |
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(3 |
%) |
Pharmaceutical and clinical service revenue |
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14.8 |
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12.6 |
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18 |
% |
Total Revenue |
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$ |
194.0 |
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$ |
196.5 |
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(1 |
%) |
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Income Statement |
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Fiscal Second-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 |
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$ |
194.0 |
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$ |
196.5 |
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(1 |
%) |
Gross Profit |
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149.6 |
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152.1 |
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(2 |
%) |
Gross Margin |
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77.1 |
% |
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77.4 |
% |
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Operating Expenses |
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145.2 |
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135.1 |
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8 |
% |
Operating Income |
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4.4 |
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17.0 |
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(74 |
%) |
Operating Margin |
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2.3 |
% |
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8.7 |
% |
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Adjusted Operating Income |
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28.2 |
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23.6 |
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20 |
% |
Adjusted Operating Margin |
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14.5 |
% |
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12.0 |
% |
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Net Income |
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32.1 |
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5.9 |
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444 |
% |
Diluted EPS |
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0.45 |
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0.09 |
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400 |
% |
Adjusted EPS |
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$ |
0.31 |
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$ |
0.26 |
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19 |
% |
Business Highlights
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• |
Hereditary Cancer |
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o |
Achieved the fourth consecutive quarter of year-over-year volume growth and again exceeded our three percent fiscal 2018 volume growth target. |
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o |
Presented pivotal validation data for riskScore® at the San Antonio Breast Cancer Symposium (SABCS) with data from over 1,617 women. The results show that riskScore is a highly statistically significant predictor of the 5-year and lifetime risk of breast cancer (p=5.2x10-39 and p=4.1x10-35, respectively). |
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o |
Successful commercial launch of riskScore led to an acceleration in preventive care hereditary cancer test volumes. |
3
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o |
Announced data from 1,200 patient prospective randomized controlled trial showing GeneSight led to a highly statistically significant improvement in the gold-standard outcomes of response and remission (p<0.01 and p=0.01 respectively). |
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o |
GeneSight revenue increased 46 percent year-over-year with double-digit, sequential volume growth. |
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o |
Announced top-line data from 2,000 patient IMPACT study demonstrating that with GeneSight primary care physicians saw even better outcomes when compared to psychiatrists. |
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o |
Announced the PRIME Care study in conjunction with the Department of Veterans Affairs, which will be a randomized controlled trial enrolling over 2,000 patients with major depressive disorder at 21 VA medical centers. The Department of Veterans Affairs has committed over $12 million to fund the study, which will evaluate how the GeneSight test influences the key endpoints of remission, response, and symptom improvement relative to patients receiving standard of care therapy. |
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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 more than three times better at predicting radiographic progression compared to 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 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 for those with high Vectra DA scores compared to those with low Vectra DA scores. |
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o |
Submitted a new publication on Vectra DA showing the change in Vectra DA scores required to recommend a modification in treatment. This clinical utility data will be utilized to add a medical management protocol to the Vectra DA test report. |
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o |
Published clinical utility study for a new indication in the Annals of Rheumatic Diseases demonstrating that in over 70,000 Medicare patients there was a strong link between Vectra DA score and cardiovascular disease. |
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• |
Prolaris® |
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o |
Finalized Medicare Local Coverage Decision (LCD) for favorable intermediate prostate cancer patients. |
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o |
Prolaris volumes grew in the double-digits on a year-over-year basis. |
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• |
EndoPredict® |
|
o |
United States test volumes increased over 70 percent on a sequential basis. |
|
o |
Presented chemopredictive data at SABCS demonstrating the ability of EndoPredict to predict response to neoadjuvant therapy in 217 women with HR+ breast cancer. The study found that patients with a low EndoPredict score were significantly more responsive to endocrine therapy (p=0.015) and women with a high EndoPredict score were significantly more responsive to neoadjuvant chemotherapy (p=0.0001). |
4
|
o |
Received FDA approval for BRACAnalysis® CDx as a companion diagnostic in conjunction with AstraZeneca’s Lynparza (olaparib) for HER2- metastatic breast cancer. |
|
o |
Pfizer presented positive data from the phase 3 EMBRACA trial in metastatic breast cancer using talazoparib, Pfizer’s investigational PARP inhibitor and Myriad’s BRACAnalysis CDx test as a companion diagnostic. Myriad plans to submit a supplementary premarket approval application to the U.S. Food and Drug Administration under its existing PMA for BRACAnalysis CDx to include talazoparib. |
|
o |
Announced an expanded research agreement with AstraZeneca using the company's myChoice® HRD Plus test in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with Lynparza (olaparib) and Avastin (bevacizumab). |
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• |
Impact of Tax Reform |
|
o |
The company estimates that the tax reform legislation will positively benefit our fiscal 2018 full year adjusted earnings per share by approximately $0.06 with $0.02 recorded in the fiscal second quarter, and the remaining $0.04 benefit anticipated across the second half of fiscal year 2018. |
Fiscal Year 2018 and Fiscal Third-Quarter 2018 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2018 and fiscal third-quarter 2018 financial guidance:
|
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Revenue |
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GAAP Diluted Earnings Per Share |
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Adjusted Earnings Per Share |
Fiscal Year 2018 |
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$760-$770 million |
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$1.82-$1.87 |
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$1.11-$1.16 |
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|
|
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Fiscal Third-Quarter 2018 |
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$186-$188 million |
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$0.11-$0.13 |
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$0.26-$0.28 |
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 second-quarter financial results, fiscal year 2018 financial guidance, and fiscal third-quarter 2018 financial guidance.
Conference Call and Webcast
A conference call will be held today, Tuesday, February 6, 2018, at 4:30 p.m. ET to discuss Myriad’s financial results for the fiscal second-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-699-0623. International callers may dial 1-303-223-4362. All callers will be asked to reference reservation number 21879835. 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: build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and
5
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 trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
6
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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Six months ended |
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December 31, |
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December 31, |
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2017 |
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2016 |
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2017 |
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2016 |
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Molecular diagnostic testing |
|
$ |
179.2 |
|
|
$ |
183.9 |
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|
$ |
358.0 |
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|
$ |
348.9 |
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Pharmaceutical and clinical services |
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14.8 |
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12.6 |
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26.2 |
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25.0 |
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Total revenue |
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194.0 |
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196.5 |
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384.2 |
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373.9 |
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Costs and expenses: |
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Cost of molecular diagnostic testing |
|
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37.7 |
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37.4 |
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|
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73.9 |
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|
|
71.6 |
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Cost of pharmaceutical and clinical services |
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6.7 |
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7.0 |
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|
|
13.5 |
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|
|
12.7 |
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Research and development expense |
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16.8 |
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18.6 |
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34.6 |
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38.0 |
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Change in the fair value of contingent consideration |
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13.0 |
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(3.8 |
) |
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(60.2 |
) |
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(3.2 |
) |
Selling, general, and administrative expense |
|
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115.4 |
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|
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120.3 |
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230.5 |
|
|
|
232.2 |
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Total costs and expenses |
|
|
189.6 |
|
|
|
179.5 |
|
|
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292.3 |
|
|
|
351.3 |
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Operating income |
|
|
4.4 |
|
|
|
17.0 |
|
|
|
91.9 |
|
|
|
22.6 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest income |
|
|
0.4 |
|
|
|
0.3 |
|
|
|
0.8 |
|
|
|
0.6 |
|
Interest expense |
|
|
(0.7 |
) |
|
|
(2.6 |
) |
|
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(1.7 |
) |
|
|
(3.3 |
) |
Other |
|
|
(0.4 |
) |
|
|
(2.6 |
) |
|
|
(0.7 |
) |
|
|
(3.8 |
) |
Total other income (expense): |
|
|
(0.7 |
) |
|
|
(4.9 |
) |
|
|
(1.6 |
) |
|
|
(6.5 |
) |
Income before income tax |
|
|
3.7 |
|
|
|
12.1 |
|
|
|
90.3 |
|
|
|
16.1 |
|
Income tax provision |
|
|
(28.4 |
) |
|
|
6.2 |
|
|
|
(22.8 |
) |
|
|
11.4 |
|
Net income |
|
$ |
32.1 |
|
|
$ |
5.9 |
|
|
$ |
113.1 |
|
|
$ |
4.7 |
|
Net loss attributable to non-controlling interest |
|
|
— |
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|
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— |
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|
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(0.1 |
) |
|
|
— |
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Net income attributable to Myriad Genetics, Inc. stockholders |
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$ |
32.1 |
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$ |
5.9 |
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$ |
113.2 |
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$ |
4.7 |
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Earnings per share: |
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|
|
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|
|
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|
|
|
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Basic |
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$ |
0.46 |
|
|
$ |
0.09 |
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|
$ |
1.64 |
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|
$ |
0.07 |
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Diluted |
|
$ |
0.45 |
|
|
$ |
0.09 |
|
|
$ |
1.59 |
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|
$ |
0.07 |
|
Weighted average shares outstanding: |
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|
|
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|
|
|
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Basic |
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69.3 |
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|
|
68.2 |
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|
|
68.9 |
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|
|
68.5 |
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Diluted |
|
|
71.9 |
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|
|
68.3 |
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|
|
71.2 |
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|
|
68.9 |
|
7
Consolidated Balance Sheets (Unaudited)
(in millions)
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December 31, |
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June 30, |
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ASSETS |
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2017 |
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2017 |
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Current assets: |
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Cash and cash equivalents |
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$ |
88.7 |
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$ |
102.4 |
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Marketable investment securities |
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54.8 |
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|
|
48.3 |
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Prepaid expenses |
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|
9.8 |
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|
|
12.7 |
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Inventory |
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|
38.2 |
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|
|
42.2 |
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Trade accounts receivable, less allowance for doubtful accounts of $9.5 December 31, |
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|
|
|
|
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|
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2017 and $8.2 June 30, 2017 |
|
|
121.1 |
|
|
|
105.6 |
|
Prepaid taxes |
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|
8.4 |
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|
|
0.2 |
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Other receivables |
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|
6.0 |
|
|
|
5.7 |
|
Total current assets |
|
|
327.0 |
|
|
|
317.1 |
|
Property, plant and equipment, net |
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|
48.4 |
|
|
|
51.1 |
|
Long-term marketable investment securities |
|
|
58.5 |
|
|
|
48.5 |
|
Intangibles, net |
|
|
475.2 |
|
|
|
491.6 |
|
Goodwill |
|
|
319.4 |
|
|
|
316.1 |
|
Total assets |
|
$ |
1,228.5 |
|
|
$ |
1,224.4 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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|
Current liabilities: |
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|
|
|
|
|
|
|
Accounts payable |
|
$ |
25.1 |
|
|
$ |
22.0 |
|
Accrued liabilities |
|
|
60.8 |
|
|
|
65.6 |
|
Short-term contingent consideration |
|
|
70.0 |
|
|
|
127.3 |
|
Deferred revenue |
|
|
3.4 |
|
|
|
2.6 |
|
Total current liabilities |
|
|
159.3 |
|
|
|
217.5 |
|
Unrecognized tax benefits |
|
|
33.4 |
|
|
|
25.2 |
|
Other long-term liabilities |
|
|
6.6 |
|
|
|
7.2 |
|
Contingent consideration |
|
|
11.0 |
|
|
|
13.2 |
|
Long-term debt |
|
|
43.2 |
|
|
|
99.1 |
|
Long-term deferred taxes |
|
|
60.8 |
|
|
|
84.4 |
|
Total liabilities |
|
|
314.3 |
|
|
|
446.6 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, 69.4 and 68.4 shares outstanding at December 31, 2017 and June 30, 2017 respectively |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
871.1 |
|
|
|
851.4 |
|
Accumulated other comprehensive loss |
|
|
(2.4 |
) |
|
|
(5.5 |
) |
Retained earnings (deficit) |
|
|
44.8 |
|
|
|
(68.4 |
) |
Total Myriad Genetics, Inc. stockholders’ equity |
|
|
914.2 |
|
|
|
778.2 |
|
Non-Controlling Interest |
|
|
— |
|
|
|
(0.4 |
) |
Total stockholders' equity |
|
|
914.2 |
|
|
|
777.8 |
|
Total liabilities and stockholders’ equity |
|
$ |
1,228.5 |
|
|
$ |
1,224.4 |
|
8
Consolidated Statement of Cash Flows (Unaudited)
(in millions)
|
|
Six months ended December 31, |
|
|||||
|
|
2017 |
|
|
2016 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net Income attributable to Myriad Genetics, Inc. stockholders |
|
$ |
113.2 |
|
|
|
4.7 |
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
26.3 |
|
|
|
22.1 |
|
Non-cash interest expense |
|
|
0.1 |
|
|
|
0.3 |
|
Gain (loss) on disposition of assets |
|
|
0.1 |
|
|
|
(0.2 |
) |
Share-based compensation expense |
|
|
13.3 |
|
|
|
15.2 |
|
Impairment of cost basis investment |
|
|
— |
|
|
|
2.5 |
|
Bad debt expense |
|
|
16.0 |
|
|
|
18.1 |
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
1.3 |
|
Deferred income taxes |
|
|
(25.9 |
) |
|
|
2.9 |
|
Unrecognized tax benefits |
|
|
8.2 |
|
|
|
0.6 |
|
Change in fair value of contingent consideration |
|
|
(60.2 |
) |
|
|
(3.2 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
2.9 |
|
|
|
8.3 |
|
Trade accounts receivable |
|
|
(32.5 |
) |
|
|
(24.4 |
) |
Other receivables |
|
|
1.5 |
|
|
|
(2.4 |
) |
Inventory |
|
|
4.1 |
|
|
|
(10.4 |
) |
Prepaid taxes |
|
|
(8.5 |
) |
|
|
(0.4 |
) |
Accounts payable |
|
|
3.0 |
|
|
|
(2.0 |
) |
Accrued liabilities |
|
|
(5.8 |
) |
|
|
(5.0 |
) |
Deferred revenue |
|
|
0.7 |
|
|
|
0.5 |
|
Net cash provided by operating activities |
|
|
56.5 |
|
|
|
28.5 |
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(3.7 |
) |
|
|
(3.9 |
) |
Acquisitions, net of cash acquired |
|
|
— |
|
|
|
(216.1 |
) |
Purchases of marketable investment securities |
|
|
(61.3 |
) |
|
|
(49.0 |
) |
Proceeds from maturities and sales of marketable investment securities |
|
|
45.2 |
|
|
|
108.9 |
|
Net cash used in investing activities |
|
|
(19.8 |
) |
|
|
(160.1 |
) |
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net proceeds from common stock issued under share-based compensation plans |
|
|
6.3 |
|
|
|
1.0 |
|
Net proceeds from revolving credit facility |
|
|
— |
|
|
|
204.0 |
|
Repayment of revolving credit facility |
|
|
(56.0 |
) |
|
|
— |
|
Net proceeds from term loan |
|
|
— |
|
|
|
199.0 |
|
Repayment of term loan |
|
|
— |
|
|
|
(200.0 |
) |
Fees paid for extinguishment of debt |
|
|
— |
|
|
|
(0.6 |
) |
Repurchase and retirement of common stock |
|
|
— |
|
|
|
(31.6 |
) |
Proceeds from Non-Controlling Interest |
|
|
0.3 |
|
|
|
— |
|
Net cash provided by (used in) financing activities |
|
|
(49.4 |
) |
|
|
171.8 |
|
Effect of foreign exchange rates on cash and cash equivalents |
|
|
(1.0 |
) |
|
|
(0.7 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
(13.7 |
) |
|
|
39.5 |
|
Cash and cash equivalents at beginning of the period |
|
|
102.4 |
|
|
|
68.5 |
|
Cash and cash equivalents at end of the period |
|
$ |
88.7 |
|
|
$ |
108.0 |
|
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 belief that its strategy to build upon the solid foundation of its hereditary cancer business with diversified revenues from its industry-leading pipeline of new products will deliver significant future revenue and earnings growth; the Company’s expectation that the PRIME Care study will enroll over 2,000 patients with major depressive disorders at 21 VA medical centers; the Company’s expectation that it will submit a supplementary premarket approval application to the FDA under its existing PMA for BRACAnalysis CDx to include talazoparib; the Company’s third-quarter revenue guidance of $186 to $188 million, GAAP diluted earnings per share of $0.11 to $0.13, and adjusted earnings per share of $0.26 to $0.28, and the Company’s increased fiscal full year revenue guidance of total revenue of $760 to $770 million, GAAP diluted earnings per share guidance of $1.82 to $1.87, and adjusted earnings per share guidance of $1.11 to $1.16, as further discussed under the captions “Fiscal Year 2018 and Fiscal Third-Quarter 2018 Financial Guidance” and “Reconciliation of GAAP and Non-GAAP for Fiscal Year 2018 and Fiscal Third-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 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.
10
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:
|
• |
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 |
|
• |
Potential future consideration related to acquisitions – Non-cash expenses related to valuation adjustments of earn-out and milestone payments tied to recent acquisitions |
|
• |
Impairment of Raindance Investment – One-time impairment charge associated with Myriad’s investment in Raindance Technologies |
|
• |
One-time debt restructuring costs – Charges related to the restructuring of the company’s debt from a one-year term loan to a revolving credit facility |
|
• |
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.
11
Reconciliation of GAAP to Non-GAAP Financial Measures
for the Three and Six Months ended December 31, 2017 and 2016
(Unaudited data in millions, except per share amount)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
Dec 31, 2017 |
|
|
Dec 31, 2016 |
|
|
Dec 31, 2017 |
|
|
Dec 31, 2016 |
|
||||
Revenue |
|
$ |
194.0 |
|
|
$ |
196.5 |
|
|
$ |
384.2 |
|
|
$ |
373.9 |
|
GAAP Cost of molecular diagnostic testing |
|
$ |
37.7 |
|
|
$ |
37.4 |
|
|
$ |
73.9 |
|
|
$ |
71.6 |
|
GAAP Cost of pharmaceutical and clinical services |
|
|
6.7 |
|
|
|
7.0 |
|
|
|
13.5 |
|
|
|
12.7 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Non-GAAP COGS |
|
$ |
44.4 |
|
|
$ |
44.4 |
|
|
$ |
87.4 |
|
|
$ |
84.3 |
|
Non-GAAP Gross Margin |
|
|
77 |
% |
|
|
77 |
% |
|
|
77 |
% |
|
|
77 |
% |
GAAP Research and Development |
|
$ |
16.8 |
|
|
$ |
18.6 |
|
|
$ |
34.6 |
|
|
$ |
38.0 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(0.1 |
) |
Acquisition - amortization of intangible assets |
|
|
(0.1 |
) |
|
|
(0.1 |
) |
|
|
(0.2 |
) |
|
|
(0.2 |
) |
Elevate 2020 costs |
|
|
(0.1 |
) |
|
|
— |
|
|
|
(0.1 |
) |
|
|
— |
|
Non-GAAP R&D |
|
$ |
16.6 |
|
|
$ |
18.5 |
|
|
$ |
34.3 |
|
|
$ |
37.7 |
|
GAAP Contingent Consideration |
|
$ |
13.0 |
|
|
$ |
(3.8 |
) |
|
$ |
(60.2 |
) |
|
$ |
(3.2 |
) |
Potential future consideration related to acquisitions |
|
|
(13.0 |
) |
|
|
3.8 |
|
|
|
60.2 |
|
|
|
3.2 |
|
Non-GAAP Contingent Consideration |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
GAAP Selling, General and Administrative |
|
$ |
115.4 |
|
|
$ |
120.3 |
|
|
$ |
230.5 |
|
|
$ |
232.2 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
(1.1 |
) |
|
|
— |
|
|
|
(11.0 |
) |
Acquisition - amortization of intangible assets |
|
|
(9.1 |
) |
|
|
(9.2 |
) |
|
|
(18.3 |
) |
|
|
(14.5 |
) |
Elevate 2020 costs |
|
|
(1.5 |
) |
|
|
— |
|
|
|
(2.7 |
) |
|
|
— |
|
Non-GAAP SG&A |
|
$ |
104.8 |
|
|
$ |
110.0 |
|
|
$ |
209.5 |
|
|
$ |
206.7 |
|
GAAP Operating Income |
|
$ |
4.4 |
|
|
$ |
17.0 |
|
|
$ |
91.9 |
|
|
$ |
22.6 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
1.1 |
|
|
|
— |
|
|
|
11.1 |
|
Acquisition - amortization of intangible assets |
|
|
9.2 |
|
|
|
9.3 |
|
|
|
18.5 |
|
|
|
14.7 |
|
Elevate 2020 costs |
|
|
1.6 |
|
|
|
— |
|
|
|
2.8 |
|
|
|
— |
|
Potential future consideration related to acquisitions |
|
|
13.0 |
|
|
|
(3.8 |
) |
|
|
(60.2 |
) |
|
|
(3.2 |
) |
Non-GAAP Operating Income |
|
$ |
28.2 |
|
|
$ |
23.6 |
|
|
$ |
53.0 |
|
|
$ |
45.2 |
|
Non-GAAP Operating Margin |
|
|
15 |
% |
|
|
12 |
% |
|
|
14 |
% |
|
|
12 |
% |
GAAP Net Income Attributable to Myriad Genetics, Inc. Stockholders |
|
$ |
32.1 |
|
|
|
5.9 |
|
|
$ |
113.2 |
|
|
$ |
4.7 |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
1.1 |
|
|
|
— |
|
|
|
11.1 |
|
Acquisition - amortization of intangible assets |
|
|
9.2 |
|
|
|
9.3 |
|
|
|
18.5 |
|
|
|
14.7 |
|
Elevate 2020 costs |
|
|
1.6 |
|
|
|
— |
|
|
|
2.8 |
|
|
|
— |
|
Potential future consideration related to acquisitions |
|
|
13.0 |
|
|
|
(3.8 |
) |
|
|
(60.2 |
) |
|
|
(3.2 |
) |
Tax impact related to equity compensation |
|
|
(0.6 |
) |
|
|
0.6 |
|
|
|
(0.3 |
) |
|
|
3.0 |
|
One-time debt restructuring costs |
|
|
— |
|
|
|
1.3 |
|
|
|
— |
|
|
|
1.3 |
|
One-time non-deductible costs |
|
|
— |
|
|
|
1.4 |
|
|
|
— |
|
|
|
4.2 |
|
Tax reform affect on deferred taxes |
|
|
(32.6 |
) |
|
|
|
|
|
|
(32.6 |
) |
|
|
|
|
Impairment of Raindance Investment |
|
|
— |
|
|
|
3.4 |
|
|
|
— |
|
|
|
3.4 |
|
Tax effect associated with non-GAAP adjustments |
|
|
(0.4 |
) |
|
|
(1.7 |
) |
|
|
(0.9 |
) |
|
|
(5.7 |
) |
Non-GAAP Net Income |
|
$ |
22.3 |
|
|
$ |
17.5 |
|
|
$ |
40.5 |
|
|
$ |
33.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Diluted EPS |
|
$ |
0.45 |
|
|
$ |
0.09 |
|
|
$ |
1.59 |
|
|
$ |
0.07 |
|
Non-GAAP Diluted EPS |
|
$ |
0.31 |
|
|
$ |
0.26 |
|
|
$ |
0.57 |
|
|
$ |
0.49 |
|
Diluted shares outstanding |
|
|
71.9 |
|
|
|
68.3 |
|
|
|
71.2 |
|
|
|
68.9 |
|
12
(Unaudited data in millions)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
Dec 31, 2017 |
|
|
Dec 31, 2016 |
|
|
Dec 31, 2017 |
|
|
Dec 31, 2016 |
|
||||
GAAP cash flow from operations |
|
$ |
33.0 |
|
|
$ |
31.4 |
|
|
$ |
56.5 |
|
|
$ |
28.5 |
|
Capital expenditures |
|
|
(2.1 |
) |
|
|
(2.4 |
) |
|
|
(3.7 |
) |
|
|
(3.9 |
) |
Free cash flow |
|
$ |
30.9 |
|
|
$ |
29.0 |
|
|
$ |
52.8 |
|
|
$ |
24.6 |
|
Elevate 2020 costs |
|
|
1.6 |
|
|
|
— |
|
|
|
2.8 |
|
|
|
— |
|
Acquisition - Integration related costs |
|
|
— |
|
|
|
1.1 |
|
|
|
— |
|
|
|
9.0 |
|
Cash paid at closing to Assurex vendors |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
6.8 |
|
Tax effect associated with non-GAAP adjustments |
|
|
(0.6 |
) |
|
|
(0.4 |
) |
|
|
(1.1 |
) |
|
|
(6.1 |
) |
Non-GAAP Free cash flow |
|
$ |
31.9 |
|
|
$ |
29.7 |
|
|
$ |
54.5 |
|
|
$ |
34.3 |
|
Reconciliation of GAAP to Non-GAAP for Fiscal Year 2018 and Fiscal Third-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 |
|
$1.82 - $1.87 |
Acquisition - amortization of intangible assets |
|
0.52 |
Change in contingent consideration |
|
(0.85) |
Tax reform impact on deferred taxes |
|
(0.46) |
One-time expenses |
|
0.08 |
Non-GAAP diluted net income per share |
|
$1.11 - $1.16 |
|
|
|
|
|
Fiscal Third-Quarter 2018 |
Diluted net income per share |
|
|
GAAP diluted net income per share |
|
$0.11 - $0.13 |
Acquisition - amortization of intangible assets |
|
0.12 |
One-time expenses |
|
0.03 |
Non-GAAP diluted net income per share |
|
$0.26- $0.28 |
Myriad Genetics Fiscal Second-Quarter 2018 Earnings Call 02/06/2018 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 Financial Guidance Fiscal Year 2018 GAAP diluted earnings per share $1.82 - $1.87 Acquisition – amortization of intangible assets $0.52 Change in contingent consideration ($0.85) Tax reform impact on deferred taxes ($0.46) One time charges $0.08 Non-GAAP diluted earnings per share $1.11 - $1.16 Fiscal Third-Quarter 2018 GAAP diluted earnings per share $0.11 - $0.13 Acquisition – amortization of intangible assets $0.12 One time charges $0.03 Non-GAAP diluted earnings per share $0.26 - $0.28 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/ Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
FY 2018 Second-Quarter Financial Results Significantly Exceed Expectations 2Q18 Actual Results 2Q17 Actual Results YoY Change Revenue (in mil.) $194.0 $196.5 (1%) GAAP EPS $0.45 $0.09 400% Adjusted EPS $0.31 $0.26 19% Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Critical Success Factors to Achieving Strategic Goals Grow new product volume STRATEGIC GOALS CRITICAL SUCCESS FACTORS >10% Revenue Growth >30% Operating Margin 7 Products >$50M >10% International Revenue Expand reimbursement coverage for new products Increase RNA kit revenue internationally Improve profitability with Elevate 2020 Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Build upon solid hereditary cancer foundation
Solid Hereditary Cancer Foundation 4th Straight Quarter With Year-Over-Year Volume Growth Hereditary cancer revenue up slightly sequentially in-line with expectations 4th straight quarter with YoY volume growth Exceeded 3% volume growth target in 2Q18 Successful riskScore™ launch led to accelerating growth in Preventive Care U.S. Oncology & ION Customizable Panels Digital Integration riskScore® Competitor Quality Concerns Key Drivers of Volume Trends Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Grow New Product Volume New Product Volume Grows Double-Digits; Revenue Sets New Record Double-digit YoY Growth ≈30% ≈70% New products comprise ≈70% of test volume New product YoY volume grew at double-digit rate New products set new record at 35% of total revenue EndoPredict volume up >70% sequentially Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Expand Reimbursement Coverage For New Products Several Key Reimbursement Catalysts in Fiscal Year 2018 Current U.S. Reimbursement Final Medicare LCD for EndoPredict became effective Jan. 30 Prolaris favorable intermediate covered by Medicare Potential NCCN guidelines for Prolaris New Vectra DA utility guiding studies at ACR GeneSight trial showed statistically significant improvement in response and remission in MDD IMPACT study shows primary care MDs have even better outcomes than psychiatrists with GeneSight Potential NCCN guidelines for myPath Melanoma Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Improve Profitability With Elevate 2020 2nd Straight Quarter of Operating Expense Declines Adjusted Operating Expenses FY18 Targeted Savings = $17M Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
FY 2018 Second-Quarter Revenue By Product Product 2Q18 2Q17 YoY Growth Hereditary Cancer $126.9 $143.9 (12%) GeneSight $31.7 $21.7 46% Vectra DA $11.1 $10.7 4% Prolaris $5.0 $3.1 61% EndoPredict $2.0 $1.6 25% Other $2.5 $2.9 (14%) Total Molecular Diagnostic Revenue $179.2 $183.9 (3%) Pharmaceutical & Clinical Services $14.8 $12.6 18% Total Revenue $194.0 $196.5 (1%) (in millions) Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Fiscal Second-Quarter Financial Results Adjusted Earnings Per Share Increase 19% Over Q2 FY2017 2Q18 2Q17 YoY Growth Total Revenue $194.0 $196.5 (1%) Gross Profit $149.6 $152.1 (2%) Gross Margin 77.1% 77.4% -30 bps Operating Income $4.4 $17.0 (74%) Adjusted Operating Income $28.2 $23.6 20% Adjusted Operating Margin 14.5% 12.0% +250 bps Net Income $32.1 $5.9 444% Diluted EPS $0.45 $0.09 400% Adjusted EPS $0.31 $0.26 19% Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Comparison of Adjusted EPS and FCF/Share Adjusted EPS Significantly Understates Cash Earnings Power Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. TTM FCF/Share = $1.90
FY18 and 3Q18 Financial Guidance Raising FY18 Financial Outlook Metric Fiscal Year 2018 Fiscal Third-Quarter 2018 Revenue $760 to $770 million $186 to $188 million GAAP Diluted EPS $1.82 to $1.87 $0.11 to $0.13 Adjusted EPS $1.11 to $1.16 $0.26 to $0.28 Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Potential Financial Catalysts Good Progress on Multiple Possibilities for Material Upsides Product Potential Catalyst Progress Continued Improvements in Volume Growth >3% growth in 1H18 Metastatic Breast Cancer Indication FDA approval in 3Q18 Additional Reimbursement Successful RCT study Successful IMPACT study ACR Guidelines & Reimbursement Increased Medicare rate under PAMA Additional Reimbursement Increased Medicare rate under PAMA; new NCCN guidelines Increased Adoption in U.S. 2% U.S. Market Share Additional Reimbursement New NCCN guidelines Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
riskScore Validation Presented at SABCS Identifies More Elevated Risk Patients Than BRCA Testing 7% of patients >30% lifetime risk 38% of patients >20% lifetime risk 12% 20% 30% 1% 66% Lifetime Risk of Breast Cancer General population
Expanded Opportunity in Hereditary Prostate Cancer Testing Volume Up 10x in Last Year Previous Guidelines 20,000 Patients New Guidelines 26,000 Patients 46,000 Patient Opportunity New consensus guidelines published in the Journal of Clinical Oncology recommend routine counseling for prostate patients on hereditary cancer risks NCCN guidelines recommend all metastatic prostate cancer patients tested for hereditary mutations HOXB13 added to myRisk Hereditary Cancer Panel Commercializing through both Oncology and Urology channels
Additional FDA Approval for BRACAnalysis CDx 125,000 Metastatic Breast Cancer Patients Now Eligible for Testing Previous Guidelines 20,000 Patients New Guidelines 26,000 Patients 125,000 patients highly motivated to know BRCA status Collaborating with AstraZeneca and Merck Launched one of our largest digital marketing campaigns to drive patient awareness Increased targeting to 3,300 oncologists who treat 75% of patients with metastatic breast cancer Diagnosed with or progress to metastatic disease HER2+ 40,000 HER2- 60,000 155,000 Don’t progress to metastatic disease 255,000 cases of invasive breast cancer
Continued Opportunity for Market Expansion With CDx Additional Indications Could Total $700M Opportunity Copyright © 2018 Myriad Genetics, Inc. all rights reserved. www.myriad.com CDx U.S. Market Opportunity (in mil.) Indications for BRACAnalysis CDx or myChoice HRD/Plus
GeneSight Study Significant for Most Important Endpoints Beginning Discussions With Commercial Payers Remission, response, and symptom improvement were durable and continued to improve over the 24-week study period 40 antidepressant FDA registration studies in the last 20 years: All were compared to placebo, not active drug like GeneSight Only 13% showed statistical significance for Remission Only 33% showed statistical significance for Response Study endpoint What it Means 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 Copyright © 2018 Myriad Genetics, Inc. all rights reserved. www.myriad.com
Two Additional Major Studies on GeneSight Underway Will Further Strengthen Supporting Clinical Evidence for the Test IMPACT Study PRIME Care (VA) Study Conducted in conjunction with the Canadian Centre for Addiction and Mental Health Open-label study with 8,000 patients enrolled to date with any mental health disorder Data on 2,000 depressed patients comparing outcomes between primary care and psychiatrists Primary care had even better outcomes than psychiatrists (p=0.0005) Conducted in conjunction with the Veterans Affairs Administration Randomized controlled trial planning to enroll 2,000 patients at 21 VA medical centers VA has committed $12M to fund the study Important for establishing coverage for Dept. of Defense personnel Copyright © 2018 Myriad Genetics, Inc. all rights reserved. www.myriad.com
Pathway To Expanded Vectra DA Reimbursement Additional Data and ACR Guidelines by End of Fiscal Year Payer Questions Progress Is Vectra DA included in guidelines? Included in United Rheumatology guidelines in Dec. 2016 (represents 10% of rheumatologists) Considered for ACR guidelines H2FY18 How does Vectra DA compare to historical measures of disease activity? Two major studies presented at ACR 2017 showing Vectra DA was more than three times better than conventional disease activity measures How should physicians modify treatment based upon Vectra DA score? Publication submitted in Q3FY18 on meaningful change in Vectra DA score Medical management protocol to be added to the test report When doctors follow the Medical Management Protocol does it lead to improved outcomes? Retrospective data available by end of FY18 Prospective data from ongoing demonstration studies in two years Copyright © 2018 Myriad Genetics, Inc. all rights reserved. www.myriad.com
New Data Supports Vectra DA Use for Assessing Cardiac Risk Potential Future Expanded Indication on Test Report Risk of Major Cardiac Event ≈3x Increased Risk Copyright © 2018 Myriad Genetics, Inc. all rights reserved. www.myriad.com Source: Ann Rheumatic Disease Dec. 2017 - Biomarker-related risk for myocardial infarction and serious infections in patients with rheumatoid arthritis: a population-based study
First Chemopredictive Data Presented on EndoPredict Highly Predictive of Response to Neoadjuvant Chemotherapy Copyright © 2018 Myriad Genetics, Inc. all rights reserved. www.myriad.com EndoPredict Low Score EndoPredict High Score p value Response to neo-adjuvant chemotherapy 0% 26.4% 0.0001 Response to endocrine therapy 27.3% 7.7% 0.015 Source: SABCS Presentation 2017 - The EndoPredict score predicts residual cancer burden to neoadjuvant chemotherapy and to neuroendocrine therapy in HR+/HER2- breast cancer patients from ABCSG34.
myPath Melanoma Represents Significant Market 300,000 Patients Per Year in the U.S. have Uncertain Diagnosis Copyright © 2018 Myriad Genetics, Inc. all rights reserved. www.myriad.com ≈ 2.0 Million Skin Biopsies for Melanoma Per Year ≈ 15% Discordance 300,000 Uncertain Cases $500M U.S. Market Opportunity
Worldwide Leader in Personalized Medicine We are entering the golden age for personalized medicine Molecular diagnostics are the keystone for improving patient outcomes while eliminating waste in healthcare spending Myriad is the pioneer of “research-based” and “education-centric” business model for molecular diagnostics We are the best positioned company to lead this revolution in healthcare Copyright © 2017 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.