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 5, 2019
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 5, 2019, Myriad Genetics, Inc. (“Myriad”) announced its financial results for the three and six months ended December 31, 2018. 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, 2018, 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 5, 2019 for the three and six months ended December 31, 2018. |
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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 5, 2019 |
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 Second-Quarter 2019 Financial Results
• |
Total Second-Quarter Revenues of $216.8 Million, Up 15 Percent |
• |
Second-Quarter Diluted EPS of $0.03 and Adjusted EPS of $0.38, Up 6 Percent |
SALT LAKE CITY, Feb. 5, 2019 – Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a global leader in molecular diagnostics and personalized medicine, today announced financial results for its fiscal second-quarter 2019, provided an update on recent business highlights, maintained its fiscal year 2019 financial guidance and provided fiscal third-quarter 2019 financial guidance.
"This quarter we saw a return to revenue growth for our hereditary cancer business, an acceleration in our prenatal testing and continued profitability improvements driven by the Elevate 2020 program,” said Mark C. Capone, president and CEO, Myriad Genetics. “Importantly, in the last month, we announced two pivotal events with the publication of the GeneSight GUIDED study and the launch of our expanded Women’s Health sales team, which have the potential to drive transformational growth and long-term shareholder value.”
2
The following table summarizes the financial results for the fiscal second-quarter 2019:
Revenue |
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Fiscal Second-Quarter |
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($ 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 |
$ |
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126.7 |
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122.2 |
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4% |
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GeneSight® |
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24.0 |
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31.7 |
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(24%) |
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Prenatal |
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31.2 |
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— |
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NM |
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Vectra DA® |
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11.8 |
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11.1 |
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6% |
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Prolaris® |
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6.1 |
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4.2 |
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45% |
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EndoPredict® |
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2.2 |
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2.0 |
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10% |
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Other testing revenue |
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1.0 |
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1.9 |
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(47%) |
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Total molecular diagnostic testing revenue |
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203.0 |
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173.1 |
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17% |
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Pharmaceutical and clinical service revenue |
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13.8 |
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14.8 |
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(7%) |
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Total Revenue |
$ |
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216.8 |
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$ |
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187.9 |
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15% |
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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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216.8 |
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187.9 |
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15% |
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Gross Profit |
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164.7 |
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143.5 |
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15% |
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Gross Margin |
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76.0 |
% |
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76.4 |
% |
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Operating Expenses |
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158.6 |
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137.2 |
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16% |
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Operating Income |
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6.1 |
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6.3 |
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(3%) |
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Operating Margin |
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2.8 |
% |
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3.4 |
% |
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Adjusted Operating Income |
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37.4 |
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37.0 |
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1% |
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Adjusted Operating Margin |
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17.3 |
% |
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19.7 |
% |
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Net Income |
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2.6 |
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30.9 |
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(92%) |
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Diluted EPS |
$ |
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0.03 |
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$ |
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0.43 |
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(93%) |
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Adjusted EPS |
$ |
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0.38 |
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$ |
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0.36 |
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6% |
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3
• |
Hereditary Cancer |
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o |
Revenue returned to growth for the first time since fiscal year 2014. |
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o |
Achieved eighth consecutive quarter of year-over-year hereditary cancer testing volume growth and fifth consecutive quarter with stable hereditary cancer pricing. |
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o |
Presented validation study on riskScore™ for women of Hispanic descent at the 2018 San Antonio Breast Cancer Symposium, consisting of almost 9,000 women analyzed with a proprietary test that was highly predictive of breast cancer risk (p= 7.1 x 10-19). |
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o |
Submitted our application to the Japanese Ministry of Health, Labour, and Welfare, for BRACAnalysis in hereditary cancer patients. There are approximately 3 million women in Japan who will be candidates for this test if approved. |
• |
GeneSight® |
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o |
GeneSight test volume increased 22 percent year over year. |
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o |
GeneSight revenue was negatively impacted by changes in Medicare documentation requirements and the impact on cash collections from recently implemented industry-wide laboratory benefit manager programs. |
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o |
A record 16,000 physicians ordered a GeneSight test in the fiscal second quarter. |
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o |
Published the landmark GUIDED study in the Journal of Psychiatric Research, which is the largest prospective pharmacogenomics study ever conducted in depression. The key finding of the study was that patients were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight test. |
• |
Prenatal Testing |
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o |
Prenatal testing volume increased at a double-digit rate year-over-year with total revenue increasing 12 percent sequentially. |
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o |
Completed sales force expansion in early January, tripling the number of sales representatives selling prenatal tests. |
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o |
Launched Myriad Complete application which includes patient education, cost estimators, test results, electronic reporting, and counseling tools for physician and patient customers, covering all Myriad Women’s Health products including myRisk® Hereditary Cancer. |
4
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diagnostic testing and in-vitro fertilization. |
• |
Vectra® |
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o |
Fiscal second-quarter revenue increased six percent year over year to $11.8 million. |
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o |
Published study in Rheumatology demonstrating that Vectra was five times more predictive of radiographic progression compared to historical measures of disease activity. |
• |
Prolaris® |
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o |
Fiscal second-quarter revenue increased 45 percent year-over-year to $6.1 million. |
• |
EndoPredict® |
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o |
Fiscal second-quarter revenue increased 10 percent year-over-year to $2.2 million. |
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o |
Received favorable National Comprehensive Cancer Network Guidelines. |
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o |
Received a favorable recommendation from NICE in the United Kingdom providing reimbursement coverage for the test. |
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o |
Presented data at the San Antonio Breast Cancer Symposium (SABCS) from a retrospective study with 3,746 women that evaluated the benefit of chemotherapy on 10-year distant recurrence in women with estrogen receptor positive, HER2 negative breast cancer. The study found that women with a high EndoPredict score who received chemotherapy saw a statistically significant benefit with lower rates of 10-year distant recurrence compared to high risk women who did not receive chemotherapy. |
|
o |
A second study presented at SABCS evaluated the distant recurrence rates in 1,702 women who received five years of endocrine therapy alone and were followed for 15 years. This study showed a four-fold risk of recurrence in the 5 to 15 year timeframe for women with a high EndoPredict score and demonstrates EndoPredict can identify women who will benefit from extended endocrine therapy. |
|
o |
A third, 373 patient study was presented at SABCS that is positioned to corroborate the ability of EndoPredict to predict chemotherapy benefit. This is the first prospective study to ever evaluate chemoprediction in a high-risk cohort for any breast cancer recurrence test. In a 3-year interim evaluation of the data, high-risk patients who received chemotherapy had a disease free recurrence rate of 96.3 percent compared to 91.5 percent in the high-risk patients who did not receive chemotherapy (p=0.06). |
• |
Companion Diagnostics |
|
o |
Received U.S. Food and Drug Administration approval for BRACAnalysis CDx for use in conjunction with olaparib for maintenance in first-line ovarian cancer. |
|
o |
Completed our submission in Japan for BRACAnalysis CDx as a companion diagnostic in first line ovarian cancer with olaparib. |
5
Fiscal Year 2019 and Fiscal Third-Quarter 2019 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2019 and fiscal third-quarter 2019 financial guidance:
|
Revenue |
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GAAP Diluted Earnings Per Share |
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Adjusted Earnings Per Share |
Fiscal Year 2019 |
$855-$865 million |
|
$0.40-$0.45 |
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$1.70-$1.75 |
Fiscal Third-Quarter 2019 |
$216-$218 million |
|
$0.12-$0.14 |
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$0.42-$0.44 |
Myriad’s fiscal year 2019 and third-quarter 2019 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. 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 and discuss the fiscal second-quarter financial results and fiscal year 2019 financial guidance.
Conference Call and Webcast
A conference call will be held today, Tuesday, February 5, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal second-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-888-222-6159. International callers may dial 1-303-223-4369. All callers will be asked to reference reservation number 21914704. 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: building upon a solid hereditary cancer foundation, 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.
6
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 Prolaris, ForeSight and Prequel 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.
MYRIAD GENETICS, INC. AND SUBSIDIARIES |
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CONSOLIDATED INCOME STATEMENTS (Unaudited) |
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(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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2018 |
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2017 |
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2018 |
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2017 |
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Molecular diagnostic testing |
|
$ |
203.0 |
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|
$ |
173.1 |
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|
$ |
392.0 |
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|
$ |
340.5 |
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Pharmaceutical and clinical services |
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13.8 |
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14.8 |
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27.1 |
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26.2 |
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Total revenue |
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216.8 |
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|
|
187.9 |
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419.1 |
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366.7 |
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Costs and expenses: |
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Cost of molecular diagnostic testing |
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44.0 |
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37.7 |
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86.3 |
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73.9 |
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Cost of pharmaceutical and clinical services |
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8.1 |
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6.7 |
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15.5 |
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13.5 |
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Research and development expense |
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22.4 |
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16.8 |
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43.5 |
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34.6 |
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Change in the fair value of contingent consideration |
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1.0 |
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13.0 |
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1.4 |
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(60.2 |
) |
Selling, general, and administrative expense |
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135.2 |
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107.4 |
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265.1 |
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214.6 |
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Total costs and expenses |
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210.7 |
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181.6 |
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|
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411.8 |
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276.4 |
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Operating income |
|
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6.1 |
|
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6.3 |
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7.3 |
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90.3 |
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Other income (expense): |
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Interest income |
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0.9 |
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0.4 |
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1.6 |
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0.8 |
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Interest expense |
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(3.4 |
) |
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(0.7 |
) |
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(5.6 |
) |
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(1.6 |
) |
Other |
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— |
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(0.4 |
) |
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1.1 |
|
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(0.7 |
) |
Total other expense: |
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(2.5 |
) |
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(0.7 |
) |
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(2.9 |
) |
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(1.5 |
) |
Income before income tax |
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3.6 |
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5.6 |
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4.4 |
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88.8 |
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Income tax provision |
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1.0 |
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(25.3 |
) |
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2.6 |
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(20.8 |
) |
Net income |
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$ |
2.6 |
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$ |
30.9 |
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$ |
1.8 |
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$ |
109.6 |
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Net loss attributable to non-controlling interest |
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— |
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— |
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(0.1 |
) |
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(0.1 |
) |
Net income attributable to Myriad Genetics, Inc. stockholders |
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$ |
2.6 |
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$ |
30.9 |
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$ |
1.9 |
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$ |
109.7 |
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Earnings per share: |
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Basic |
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$ |
0.04 |
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$ |
0.45 |
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$ |
0.03 |
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$ |
1.59 |
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Diluted |
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$ |
0.03 |
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$ |
0.43 |
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$ |
0.02 |
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$ |
1.54 |
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Weighted average shares outstanding: |
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Basic |
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74.2 |
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69.3 |
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73.6 |
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68.9 |
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Diluted |
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76.5 |
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71.9 |
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76.9 |
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71.2 |
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7
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December 31, |
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June 30, |
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ASSETS |
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2018 |
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2018 |
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Current assets: |
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Cash and cash equivalents |
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$ |
90.6 |
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$ |
110.9 |
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Marketable investment securities |
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74.8 |
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69.7 |
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Prepaid expenses |
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12.5 |
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9.4 |
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Inventory |
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33.3 |
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34.3 |
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Trade accounts receivable |
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116.6 |
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|
99.5 |
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Prepaid taxes |
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3.1 |
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— |
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Other receivables |
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5.9 |
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3.8 |
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Total current assets |
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336.8 |
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327.6 |
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Property, plant and equipment, net |
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59.1 |
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43.2 |
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Long-term marketable investment securities |
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29.9 |
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30.7 |
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Intangibles, net |
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717.6 |
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455.2 |
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Goodwill |
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413.2 |
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|
318.6 |
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Total assets |
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$ |
1,556.6 |
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$ |
1,175.3 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
31.9 |
|
|
$ |
26.0 |
|
Accrued liabilities |
|
|
73.7 |
|
|
|
68.3 |
|
Short-term contingent consideration |
|
|
5.3 |
|
|
|
5.3 |
|
Deferred revenue |
|
|
2.4 |
|
|
|
2.6 |
|
Total current liabilities |
|
|
113.3 |
|
|
|
102.2 |
|
Unrecognized tax benefits |
|
|
24.9 |
|
|
|
24.9 |
|
Other long-term liabilities |
|
|
6.6 |
|
|
|
6.3 |
|
Contingent consideration |
|
|
10.4 |
|
|
|
9.2 |
|
Long-term debt |
|
|
273.3 |
|
|
|
9.3 |
|
Long-term deferred taxes |
|
|
64.0 |
|
|
|
57.3 |
|
Total liabilities |
|
|
492.5 |
|
|
|
209.2 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, 73.2 and 70.6 shares outstanding at December 31, 2018 and June 30, 2018 respectively |
|
|
0.7 |
|
|
|
0.7 |
|
Additional paid-in capital |
|
|
1,045.6 |
|
|
|
915.4 |
|
Accumulated other comprehensive loss |
|
|
(5.0 |
) |
|
|
(4.1 |
) |
Retained earnings |
|
|
22.9 |
|
|
|
54.1 |
|
Total Myriad Genetics, Inc. stockholders’ equity |
|
|
1,064.2 |
|
|
|
966.1 |
|
Non-Controlling Interest |
|
|
(0.1 |
) |
|
|
— |
|
Total stockholders' equity |
|
|
1,064.1 |
|
|
|
966.1 |
|
8
Consolidated Statement of Cash Flows (Unaudited) |
|
|||||||
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
Six months ended |
|
|||||
|
|
December 31, |
|
|||||
|
|
2018 |
|
|
2017 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net Income attributable to Myriad Genetics, Inc. stockholders |
|
$ |
1.9 |
|
|
|
109.7 |
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
36.3 |
|
|
|
26.3 |
|
Non-cash interest expense |
|
|
(1.2 |
) |
|
|
0.1 |
|
Loss (gain) on disposition of assets |
|
|
(0.9 |
) |
|
|
0.1 |
|
Share-based compensation expense |
|
|
15.2 |
|
|
|
13.3 |
|
Deferred income taxes |
|
|
2.3 |
|
|
|
(25.9 |
) |
Unrecognized tax benefits |
|
|
(2.3 |
) |
|
|
8.2 |
|
Change in fair value of contingent consideration |
|
|
(1.4 |
) |
|
|
(60.2 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
0.8 |
|
|
|
2.9 |
|
Trade accounts receivable |
|
|
(0.9 |
) |
|
|
(13.0 |
) |
Other receivables |
|
|
(1.9 |
) |
|
|
1.4 |
|
Inventory |
|
|
6.1 |
|
|
|
4.1 |
|
Prepaid taxes |
|
|
(3.1 |
) |
|
|
(8.4 |
) |
Accounts payable |
|
|
(0.3 |
) |
|
|
3.0 |
|
Accrued liabilities |
|
|
(4.7 |
) |
|
|
(5.8 |
) |
Deferred revenue |
|
|
(0.3 |
) |
|
|
0.7 |
|
Net cash provided by operating activities |
|
|
45.6 |
|
|
|
56.5 |
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(4.1 |
) |
|
|
(3.7 |
) |
Acquisitions, net of cash acquired |
|
|
(278.5 |
) |
|
|
— |
|
Purchases of marketable investment securities |
|
|
(36.6 |
) |
|
|
(61.3 |
) |
Proceeds from maturities and sales of marketable investment securities |
|
|
32.1 |
|
|
|
45.2 |
|
Net cash used in investing activities |
|
|
(287.1 |
) |
|
|
(19.8 |
) |
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net proceeds from common stock issued under share-based compensation plans |
|
|
4.5 |
|
|
|
6.3 |
|
Net proceeds from revolving credit facility |
|
|
340.0 |
|
|
|
— |
|
Repayment of revolving credit facility |
|
|
(75.0 |
) |
|
|
(56.0 |
) |
Repurchase and retirement of common stock |
|
|
(50.0 |
) |
|
|
— |
|
Proceeds from non-controlling interest |
|
|
— |
|
|
|
0.3 |
|
Net cash provided by (used in) financing activities |
|
|
219.5 |
|
|
|
(49.4 |
) |
Effect of foreign exchange rates on cash and cash equivalents |
|
|
1.7 |
|
|
|
(1.0 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
(20.3 |
) |
|
|
(13.7 |
) |
Cash and cash equivalents at beginning of the period |
|
|
110.9 |
|
|
|
102.4 |
|
Cash and cash equivalents at end of the period |
|
$ |
90.6 |
|
|
$ |
88.7 |
|
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 ability to become a trusted advisor transforming patient lives worldwide with pioneering diagnostics; the Company’s expectation that the publication of the GeneSight GUIDED study and the launch of the expanded Women’s Health sales team have the potential to drive transformational growth and long-term shareholder value; the Company’s belief that the study presented at SABCS demonstrates that EndoPredict can identify women who will benefit from extended endocrine therapy; the Company’s expectation that the study presented at SABCS is positioned to corroborate the ability of EndoPredict to predict chemotherapy benefit; the Company’s fiscal year 2019 and fiscal third-quarter 2019 financial guidance for revenue, GAAP diluted earnings per share, and adjusted earnings per share under the caption “Fiscal Year 2019 and Fiscal Third-Quarter 2019 Financial Guidance”; and the Company’s strategic imperatives under the caption “About Myriad Genetics.” These “forward-looking statements” are management’s present 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 successfully transition from its existing product portfolio to its 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;
10
risks related to the Company’s ability to successfully integrate and derive benefits from any technologies or businesses that it licenses or acquires; 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.
11
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 |
|
• |
Equity compensation – non-cash equity based compensation provided to Myriad employees |
|
• |
Deferred Tax impact of non-GAAP adjustments: Changes in effective tax rate based upon ASU 2016-09 and the deferred tax impact of non-deductible acquisition costs |
|
• |
Tax reform impact – The impact of tax reform legislation on deferred tax assets |
|
• |
Potential future consideration related to acquisitions: Non-cash expenses related to valuation adjustments of earn-out and milestone payments tied to recent acquisitions |
|
• |
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 and Six months ended December 31, 2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited data in millions, except per share amount) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
Dec 31, 2018 |
|
|
Dec 31, 2017 |
|
|
Dec 31, 2018 |
|
|
Dec 31, 2017 |
|
||||
Revenue |
|
$ |
216.8 |
|
|
$ |
187.9 |
|
|
$ |
419.1 |
|
|
$ |
366.7 |
|
GAAP Cost of molecular diagnostic testing |
|
|
44.0 |
|
|
|
37.7 |
|
|
|
86.3 |
|
|
|
73.9 |
|
GAAP Cost of pharmaceutical and clinical services |
|
|
8.1 |
|
|
|
6.7 |
|
|
|
15.5 |
|
|
|
13.5 |
|
Acquisition - Integration related costs |
|
|
(0.1 |
) |
|
|
— |
|
|
|
(0.1 |
) |
|
|
— |
|
Equity Compensation |
|
|
— |
|
|
|
(0.2 |
) |
|
|
(0.2 |
) |
|
|
(0.5 |
) |
Elevate 2020 costs |
|
|
(0.6 |
) |
|
|
— |
|
|
|
(3.6 |
) |
|
|
— |
|
Non-GAAP COGS |
|
$ |
51.4 |
|
|
$ |
44.2 |
|
|
$ |
97.9 |
|
|
$ |
86.9 |
|
Non-GAAP Gross Margin |
|
|
76 |
% |
|
|
76 |
% |
|
|
77 |
% |
|
|
76 |
% |
GAAP Research and Development |
|
$ |
22.4 |
|
|
$ |
16.8 |
|
|
$ |
43.5 |
|
|
$ |
34.6 |
|
Acquisition - amortization of intangible assets |
|
|
(0.1 |
) |
|
|
(0.1 |
) |
|
|
(0.1 |
) |
|
|
(0.2 |
) |
Acquisition - Integration related costs |
|
|
(0.6 |
) |
|
|
— |
|
|
|
(0.7 |
) |
|
|
— |
|
Equity compensation |
|
|
(1.3 |
) |
|
|
(1.2 |
) |
|
|
(2.5 |
) |
|
|
(2.0 |
) |
Elevate 2020 costs |
|
|
(1.5 |
) |
|
|
(0.1 |
) |
|
|
(2.2 |
) |
|
|
(0.2 |
) |
Non-GAAP R&D |
|
$ |
18.9 |
|
|
$ |
15.4 |
|
|
$ |
38.0 |
|
|
$ |
32.2 |
|
GAAP Contingent Consideration |
|
$ |
1.0 |
|
|
$ |
13.0 |
|
|
$ |
1.4 |
|
|
$ |
(60.2 |
) |
Potential future consideration related to acquisitions |
|
|
(1.0 |
) |
|
|
(13.0 |
) |
|
|
(1.4 |
) |
|
|
60.2 |
|
Non-GAAP Contingent Consideration |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
GAAP Selling, General and Administrative |
|
$ |
135.2 |
|
|
$ |
107.4 |
|
|
$ |
265.1 |
|
|
$ |
214.6 |
|
Acquisition - amortization of intangible assets |
|
|
(15.2 |
) |
|
|
— |
|
|
|
(28.5 |
) |
|
|
— |
|
Acquisition - Integration related costs |
|
|
(3.3 |
) |
|
|
(9.1 |
) |
|
|
(12.8 |
) |
|
|
(18.2 |
) |
Equity compensation |
|
|
(6.2 |
) |
|
|
(5.5 |
) |
|
|
(12.5 |
) |
|
|
(10.8 |
) |
Elevate 2020 costs |
|
|
(1.4 |
) |
|
|
(1.5 |
) |
|
|
(2.5 |
) |
|
|
(2.7 |
) |
Non-GAAP SG&A |
|
$ |
109.1 |
|
|
$ |
91.3 |
|
|
$ |
208.8 |
|
|
$ |
182.9 |
|
GAAP Operating Income |
|
$ |
6.1 |
|
|
$ |
6.3 |
|
|
$ |
7.3 |
|
|
$ |
90.3 |
|
Acquisition - Integration related costs |
|
|
4.0 |
|
|
|
9.1 |
|
|
|
13.6 |
|
|
|
18.2 |
|
Acquisition - amortization of intangible assets |
|
|
15.3 |
|
|
|
0.1 |
|
|
|
28.6 |
|
|
|
0.2 |
|
Equity compensation |
|
|
7.5 |
|
|
|
6.9 |
|
|
|
15.2 |
|
|
|
13.3 |
|
Elevate 2020 costs |
|
|
3.5 |
|
|
|
1.6 |
|
|
|
8.3 |
|
|
|
2.9 |
|
Potential future consideration related to acquisitions |
|
|
1.0 |
|
|
|
13.0 |
|
|
|
1.4 |
|
|
|
(60.2 |
) |
Non-GAAP Operating Income |
|
$ |
37.4 |
|
|
$ |
37.0 |
|
|
$ |
74.4 |
|
|
$ |
64.7 |
|
Non-GAAP Operating Margin |
|
|
17 |
% |
|
|
20 |
% |
|
|
18 |
% |
|
|
18 |
% |
GAAP Net Income Attributable to Myriad Genetics, Inc. Stockholders |
|
$ |
2.6 |
|
|
$ |
30.9 |
|
|
$ |
1.9 |
|
|
$ |
109.7 |
|
Acquisition - Integration related costs |
|
|
4.0 |
|
|
|
9.1 |
|
|
|
13.6 |
|
|
|
18.2 |
|
Acquisition - amortization of intangible assets |
|
|
15.3 |
|
|
|
0.1 |
|
|
|
28.6 |
|
|
|
0.2 |
|
Equity compensation |
|
|
7.5 |
|
|
|
6.9 |
|
|
|
15.2 |
|
|
|
13.3 |
|
Elevate 2020 costs |
|
|
3.5 |
|
|
|
1.6 |
|
|
|
8.3 |
|
|
|
2.9 |
|
Potential future consideration related to acquisitions |
|
|
1.0 |
|
|
|
13.0 |
|
|
|
1.4 |
|
|
|
(60.2 |
) |
Tax reform impact |
|
|
— |
|
|
|
(32.6 |
) |
|
|
— |
|
|
|
(32.6 |
) |
Deferred tax impact of non-GAAP adjustments |
|
|
(0.1 |
) |
|
|
(0.6 |
) |
|
|
2.6 |
|
|
|
(0.3 |
) |
Tax effect associated with non-GAAP adjustments |
|
|
(4.6 |
) |
|
|
(2.5 |
) |
|
|
(9.7 |
) |
|
|
(4.8 |
) |
Non-GAAP Net Income |
|
$ |
29.2 |
|
|
$ |
25.9 |
|
|
$ |
61.9 |
|
|
$ |
46.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Diluted EPS |
|
$ |
0.03 |
|
|
$ |
0.43 |
|
|
$ |
0.02 |
|
|
$ |
1.54 |
|
Non-GAAP Diluted EPS |
|
$ |
0.38 |
|
|
$ |
0.36 |
|
|
$ |
0.80 |
|
|
$ |
0.65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares outstanding |
|
|
76.5 |
|
|
|
71.9 |
|
|
|
76.9 |
|
|
|
71.2 |
|
13
Free Cash Flow Reconciliation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited data in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
Dec 31, 2018 |
|
|
Dec 31, 2017 |
|
|
Dec 31, 2018 |
|
|
Dec 31, 2017 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP cash flow from operations |
|
$ |
37.8 |
|
|
$ |
33.0 |
|
|
$ |
45.6 |
|
|
$ |
56.5 |
|
Capital expenditures |
|
|
(2.8 |
) |
|
|
(5.3 |
) |
|
|
(4.1 |
) |
|
|
(3.7 |
) |
Free cash flow |
|
$ |
35.0 |
|
|
$ |
27.7 |
|
|
$ |
41.5 |
|
|
$ |
52.8 |
|
Elevate 2020 costs |
|
|
3.4 |
|
|
|
1.6 |
|
|
|
8.1 |
|
|
|
2.8 |
|
Acquisition - Integration related costs |
|
|
0.3 |
|
|
|
— |
|
|
|
8.4 |
|
|
|
— |
|
Tax effect associated with non-GAAP adjustments |
|
|
(1.1 |
) |
|
|
(0.6 |
) |
|
|
(4.0 |
) |
|
|
(1.1 |
) |
Non-GAAP Free cash flow |
|
$ |
37.6 |
|
|
$ |
28.7 |
|
|
$ |
54.0 |
|
|
$ |
54.5 |
|
Reconciliation of GAAP to Non-GAAP for Fiscal Year 2019
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.
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Fiscal Year 2019 |
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Diluted net income per share |
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GAAP diluted net income per share |
$0.40- $0.45 |
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Stock Based Compensation Expense |
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0.30 |
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Acquisition - amortization of intangible assets |
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0.80 |
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Adjustments to GAAP financial measures |
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0.20 |
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Non-GAAP diluted net income per share |
$1.70 - $1.75 |
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Fiscal Third-Quarter 2019 |
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Diluted net income per share |
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GAAP diluted net income per share |
$0.12 - $0.14 |
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Stock Based Compensation Expense |
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0.08 |
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Acquisition - amortization of intangible assets |
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0.20 |
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Adjustments to GAAP financial measures |
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0.02 |
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Non-GAAP diluted net income per share |
$0.42 - $0.44 |
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Myriad Genetics Fiscal Second-Quarter 2019 Earnings Call February 5, 2019 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 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/ Fiscal Year 2019 GAAP diluted earnings per share $0.40-$0.45 Stock based compensation expense $0.30 Acquisition – amortization of intangible assets $0.80 Adjustments to GAAP financial measures $0.20 Non-GAAP diluted earnings per share $1.70-$1.75 Fiscal Third-Quarter 2019 GAAP diluted earnings per share $0.12 - $0.14 Stock based compensation expense $0.08 Acquisition – amortization of intangible assets $0.20 Adjustments to GAAP financial measures $0.02 Non-GAAP diluted earnings per share $0.42 - $0.44
Fiscal Year 2019 Second-Quarter Financial Results 2Q19 Actual Results 2Q18 Actual Results YoY Change Revenue (in mil.) $216.8 $187.9 15% GAAP EPS $0.03 $0.43 (92%) Adjusted EPS $0.38 $0.36 6% Organic Adjusted EPS* $0.46 $0.36 28% *Excludes $0.08 of dilution from the Counsyl acquisition in the fiscal second-quarter
Critical Success Factors to Achieve Strategic Goals Expand reimbursement coverage for new products Build upon solid hereditary cancer foundation Increase RNA kit revenue internationally Improve profitability with Elevate 2020 STRATEGIC GOALS >10% REVENUE GROWTH 7 PRODUCTS >$50M >10% INT’L REVENUE >30% OPERATING MARGIN Grow new product volume
Hereditary Cancer Revenue Returns to Growth for First Time Since FY14 Solid Foundation in Hereditary Cancer Market * ASC606 Revenue Growing Volume Market less than 10% penetrated 7% CAGR since FY13 8 sequential quarters with YoY growth New indications added 175,000 eligible patients in the U.S. and Japan riskScore driving deeper penetration – Developed new version for Hispanic women BRACAnalysis® CDx approved in first-line maintenance for ovarian cancer Stable Pricing Outlook 5 consecutive quarters with stable pricing Long-term contracts provide stable pricing into FY20 UNH contract fixed until FY21 Smaller price premium easily justifiable +4%
Record Test Volume in Fiscal Second-Quarter New Products Represent 75% of >1M Test Run Rate FY13 2Q19 Annualized Run Rate 180,000 Tests > 1 Million Tests 99% 25%
Markets Remain Highly Underpenetrated Three Pillars of Prenatal Market Success A frictionless customer experience with Myriad Complete Trusted Advisors with broad physician reach and comprehensive menu Differentiate products through pioneering science
Best Physician and Patient Workflow Solution in the Industry Myriad Complete is a Key Competitive Differentiator
Based Upon Week 8 HAM-D17 Scores GUIDED EndPoints Analysis Patients Remission Rate Response Rate Symptom Improvement All Patients 1,298 +47% p=0.005 +32% p=0.007 +14% p=0.069 Mildly Depressed Patients Excluded 1,167 +50% p=0.007 +30% p=0.013 +12% p=0.107 Green Exclusion (Patients entering on green medications only excluded) 786 +70% p=0.003 +40% p=0.008 +23% p=0.029 Red Switching (Mod. to Severe depressed patients entering on red medications that switched vs. those that did not) 213 +153% p=0.007 +71% p=0.036 +59% p=0.002 Medicare Eligible (Mod.to Severe depressed patients based upon age at time of entry) 165 Statistically Significant Statistically Significant Statistically Significant
Only Test To Answer the Three Critical Questions of Prognosis, Chemotherapy Benefit, and Extended Endocrine Benefit EndoPredict ® – One Test Three Clinical Answers Outperformed market leading test in TransATAC study Large clinical validation presented at the San Antonio Breast Cancer Symposium supports the ability of EndoPredict to predict chemotherapy benefit The only test to assess risk out to 15 years. Identifies patients who can safely forego extending endocrine therapy. Prognosis Chemotherapy Benefit Extended Endocrine Therapy Benefit
EndoPredict High Risk Patients Receive Statistically Significant Benefit From Chemotherapy EndoPredict Predictive of Chemotherapy Benefit Endocrine Therapy Alone Endocrine Therapy + Chemotherapy
Low Risk EndoPredict Patients Have Substantially Lower Risk of Distant Recurrence EndoPredict Can Guide Extended Endocrine Therapy Decision Rate of Distant Recurrence HR=4.77 p=0.0001 HR=4.52 p=0.0001
Key Catalysts in FY19 Steady International Growth PRODUCT REVENUE (IN MIL.) Near-Term Growth Drivers Approval for BRACAnalysis CDx in metastatic BC in Japan Filed for Japanese regulatory approval for BRACAnalysis CDx in first-line ovarian cancer Filed for Japanese regulatory approval for hereditary cancer testing (>3M eligible patients) Positive NICE recommendation for EndoPredict reimbursement in UK Potential EndoPredict reimbursement decisions in Germany and Italy in CY20
Adjusted Operating Margins (OM) Increase 460 BP Since Inception of Elevate 2020 Excluding Counsyl Meaningful Profitability Improvement Through Elevate 2020 Elevate 2020 Progress All business units except Dermatology now profitable Operating margins have increased 460 bp since inception of the program Vectra and International laboratory moves completed at the end of the fiscal 2Q19 TOTAL EXPENSES ($M)* ADJUSTED OPERATING MARGIN* 23.1% 18.5% * Excludes Counsyl
Financial Overview
FY 2019 Second-Quarter Revenue By Product Product 2Q19 2Q18 YoY Growth Hereditary Cancer $126.7 $122.2 4% GeneSight $24.0 $31.7 (24%) Prenatal Testing $31.2 - NM Vectra $11.8 $11.1 6% Prolaris $6.1 $4.2 45% EndoPredict $2.2 $2.0 10% Other $1.0 $1.9 (47%) Total Molecular Diagnostic Revenue $203.0 $173.1 17% Pharmaceutical & Clinical Services $13.8 $14.8 (7%) Total Revenue $216.8 $187.9 15% (in millions)
Fiscal Second-Quarter Financial Results GAAP Results Adjusted Results 2Q19 2Q18 YoY Growth 2Q19 2Q18 YoY Growth Total Revenue $216.8 $187.9 15% $216.8 $187.9 15% Gross Profit $164.7 $143.5 15% $165.4 $143.7 15% Gross Margin 76.0% 76.4% -40 bps 76.3% 76.5% -20 bps Operating Income $6.1 $6.3 (3%) $37.4 $37.0 1% Operating Margin 2.8% 3.4% -60 bps 17.3% 19.7% -240 bps Net Income $2.6 $30.9 (92%) $29.2 $25.9 13% EPS $0.03 $0.43 (93%) $0.38 $0.36 6%
FY19 and 3Q FY19 Financial Guidance Metric Fiscal Year 2019 3Q19 Revenue $855 to $865 million $216 to $218 million GAAP Diluted EPS $0.40 to $0.45 $0.12 to $0.14 Adjusted EPS $1.70 to $1.75 $0.42 to $0.44
Peter D. Meldrum (1947-2018)