UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 6, 2018
MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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0-26642 |
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87-0494517 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
320 Wakara Way
Salt Lake City, Utah 84108
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (801) 584-3600
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On November 6, 2018, Myriad Genetics, Inc. (“Myriad”) announced its financial results for the three months ended September 30, 2018. The earnings release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
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ITEM 7.01 |
Regulation FD Disclosure. |
On its earnings conference call for the three months ended September 30, 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)
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Exhibit Number |
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Description |
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99.1 |
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Earnings release dated November 6, 2018 for the three months ended September 30, 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: November 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
News Release
Media Contact:Ron RogersInvestor Contact:Scott Gleason
(801) 584-3065(801) 584-1143
rrogers@myriad.comsgleason@myriad.com
Myriad Genetics Reports Fiscal First-Quarter 2019 Financial Results
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• |
Total First-Quarter Revenues of $202.3 Million, Up 13 Percent |
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• |
First-Quarter Diluted EPS of ($0.01) and Adjusted EPS of $0.43, Up 48 Percent |
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• |
Revised Full-Year Revenue Guidance to $855 to $865 Million; Maintained Diluted EPS Guidance of $0.40 to $0.45 and Adjusted EPS Guidance of $1.70 to $1.75 |
SALT LAKE CITY, Nov. 6, 2018 – Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a global leader in molecular diagnostics and personalized medicine, today announced financial results for its fiscal first-quarter 2019, provided an update on recent business highlights, revised its fiscal year 2019 financial guidance and provided fiscal second-quarter 2019 financial guidance.
"Earnings during the quarter exceeded expectations based upon strong hereditary cancer and new product volume growth,” said Mark C. Capone, president and CEO, Myriad Genetics. “Late in the quarter we identified two issues that impacted revenue for GeneSight® and prenatal testing and as a result we have revised revenue guidance for fiscal 2019. We view these issues as transitory and given the progress on profitability, earnings guidance for the fiscal year remains unchanged. As we realize synergies from the Counsyl acquisition, continue to grow new product volumes, and secure additional new product coverage decisions, we expect revenue growth and profitability to further accelerate.”
2
The following table summarizes the financial results for the fiscal first-quarter 2019:
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Revenue |
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Fiscal First-Quarter |
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($ in millions) |
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2018 |
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2017 |
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% Change |
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Molecular diagnostic testing revenue |
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Hereditary Cancer |
$ |
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116.3 |
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$ |
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117.0 |
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(1%) |
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GeneSight® |
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29.3 |
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28.8 |
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2% |
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Prenatal |
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18.1 |
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— |
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NM |
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Vectra DA® |
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13.0 |
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14.0 |
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(7%) |
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Prolaris® |
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6.2 |
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3.9 |
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59% |
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EndoPredict® |
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2.4 |
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1.8 |
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33% |
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Other testing revenue |
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3.7 |
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1.9 |
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95% |
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Total molecular diagnostic testing revenue |
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189.0 |
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167.4 |
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13% |
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Pharmaceutical and clinical service revenue |
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13.3 |
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11.4 |
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17% |
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Total Revenue |
$ |
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202.3 |
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$ |
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178.8 |
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13% |
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Income Statement |
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Fiscal First-Quarter |
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($ in millions) |
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2018 |
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2017 |
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% Change |
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Total Revenue |
$ |
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202.3 |
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178.8 |
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13% |
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Gross Profit |
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152.6 |
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135.8 |
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12% |
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Gross Margin |
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75.4 |
% |
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76.0 |
% |
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Operating Expenses |
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151.4 |
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51.8 |
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192% |
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Operating Income |
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1.2 |
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84.0 |
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(99%) |
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Operating Margin |
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0.6 |
% |
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47.0 |
% |
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Adjusted Operating Income |
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37.1 |
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27.7 |
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34% |
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Adjusted Operating Margin |
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18.3 |
% |
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15.5 |
% |
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Net Income |
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(0.7 |
) |
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78.8 |
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NM |
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Diluted EPS |
$ |
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(0.01 |
) |
$ |
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1.12 |
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NM |
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Adjusted EPS |
$ |
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0.43 |
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$ |
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0.29 |
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48% |
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3
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• |
Hereditary Cancer |
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o |
Achieved seventh consecutive quarter of year-over-year hereditary cancer testing volume growth. |
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o |
A landmark study published in the Journal of the American Medical Association demonstrated the importance of Myriad’s unique variant reclassification program. The study, which evaluated over 1.45 million patient test reports over a 10-year period, found that approximately 25 percent of all variants of unknown significance were reclassified. Nine percent of these amended reports led to an upgrade of a previously unclassified variant to a deleterious mutation. |
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o |
A recent study published in Obstetrics and Gynecology, which evaluated almost 4,000 women presenting at 15 OBGYN practices, found that when patients were screened using the National Comprehensive Cancer Network guidelines, 24 percent of women who provided family history information met criteria for hereditary cancer testing. |
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o |
Added the 29th gene, HOXB13, to the myRisk® Hereditary Cancer panel. Men with a deleterious mutation in the HOXB13 gene have up to a 52 percent lifetime risk of developing prostate cancer and should receive incremental screening. |
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GeneSight® |
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o |
GeneSight test volume increased 28 percent year over year. |
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o |
A record 15,500 physicians, including almost 2,500 new ordering doctors, ordered a GeneSight test in the fiscal first quarter. |
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o |
Anticipate acceptance of the landmark GUIDED study in the fiscal second quarter of 2019. |
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o |
Published the results of the IMPACT study in the Journal of Psychiatric Research. In the study, patients treated by primary care physicians had 27 percent greater symptom improvement, 35 percent increased response and 63 percent greater remission than those treated by psychiatrists. |
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o |
Published the results of the Optum® health economic study in Personalized Medicine. The study found that patients in the GeneSight cohort had cost savings of $5,505 in the first year. This result was highly statistically significant even after adjusting for pre-test differences between the two arms. When evaluating the subset of patients with major depressive disorder, patients who received GeneSight had total cost savings of $6,050 in the first year which also was highly statistically significant. |
4
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o |
Prenatal testing volume increased 16 percent year over year in the fiscal first quarter. |
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o |
Announced publication of a large clinical utility study for ForeSight™ in Genetics in Medicine. The study found that the ForeSight test led to significant changes in pregnancy management with 77 percent of at risk couples taking steps to avoid having an affected offspring such as prenatal diagnostic testing and in-vitro fertilization. |
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Vectra® |
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o |
Published results of a study demonstrating the minimally important difference in Vectra scores in Clinical Rheumatology. This data will form the basis of the future Vectra medical management tool on the test report. |
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o |
Received favorable guidelines supporting Vectra from Bendcare, a national organization representing greater than 160 rheumatologists in the United States. |
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Prolaris® |
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o |
Fiscal first-quarter revenue increased 59 percent year over year to $6.2 million with double-digit volume growth. |
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o |
Announced positive coverage decision from Blue Shield of California for Prolaris. This decision increases total covered commercial lives for Prolaris by 5 million and the number of total commercial lives covered to over 25 million lives in the United States. |
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EndoPredict® |
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o |
Fiscal first-quarter revenue increased 33 percent year-over-year to $2.4 million. |
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myPath® Melanoma |
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o |
Received a positive draft local coverage determination from Noridian Healthcare Solutions for myPath Melanoma. |
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o |
Received a positive guideline recommendation from the American Academy of Dermatology for use of myPath Melanoma in equivocal lesions. |
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• |
Companion Diagnostics |
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o |
Received our second FDA approval for patients with HER2- metastatic breast cancer for BRACAnalysis® CDx in conjunction with Pfizer’s PARP inhibitor talazoparib. |
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o |
Announced new research agreement with Pfizer in neo-adjuvant triple negative breast cancer using BRACAnalysis CDx. |
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o |
Filed supplementary PMA for BRACAnalysis CDx for use in conjunction with AstraZeneca’s PARP inhibitor Lynparza for maintenance in first-line ovarian cancer. |
5
Fiscal Year 2019 and Fiscal Second-Quarter 2019 Financial Guidance
Below is a table summarizing Myriad’s revised fiscal year 2019 and fiscal second-quarter 2019 financial guidance:
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Revenue |
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GAAP Diluted Earnings Per Share |
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Adjusted Earnings Per Share |
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Fiscal Year 2019 |
$855-$865 million |
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$0.40-$0.45 |
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$1.70-$1.75 |
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Fiscal Second-Quarter 2019 |
$216-$218 million |
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$0.06-$0.08 |
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$0.36-$0.38 |
Myriad’s fiscal year 2019 and fiscal second-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 fourth-quarter financial results and fiscal year 2019 financial guidance.
Conference Call and Webcast
A conference call will be held today, Tuesday, November 6, 2018, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-672-8962. International callers may dial 1-303-223-4363. All callers will be asked to reference reservation number 21897521. 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.
6
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 Prolaris, ForeSight and Prelude 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.
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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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September 30, |
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|||||
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2018 |
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2017 |
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Molecular diagnostic testing |
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$ |
189.0 |
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$ |
167.4 |
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Pharmaceutical and clinical services |
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|
13.3 |
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|
|
11.4 |
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Total revenue |
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202.3 |
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|
178.8 |
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Costs and expenses: |
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Cost of molecular diagnostic testing |
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42.3 |
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36.2 |
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Cost of pharmaceutical and clinical services |
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7.4 |
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6.8 |
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Research and development expense |
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21.1 |
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17.8 |
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Change in the fair value of contingent consideration |
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0.4 |
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(73.2 |
) |
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Selling, general, and administrative expense |
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129.9 |
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107.2 |
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Total costs and expenses |
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201.1 |
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94.8 |
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Operating income |
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1.2 |
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84.0 |
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Other income (expense): |
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|
|
|
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|
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Interest income |
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0.7 |
|
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0.4 |
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Interest expense |
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(2.2 |
) |
|
|
(0.9 |
) |
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Other |
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|
1.1 |
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|
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(0.3 |
) |
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Total other expense: |
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|
(0.4 |
) |
|
|
(0.8 |
) |
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Income before income tax |
|
|
0.8 |
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83.2 |
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Income tax provision |
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|
1.6 |
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4.5 |
|
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Net income (loss) |
|
$ |
(0.8 |
) |
|
$ |
78.7 |
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Net loss attributable to non-controlling interest |
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(0.1 |
) |
|
|
(0.1 |
) |
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Net income (loss) attributable to Myriad Genetics, Inc. stockholders |
|
$ |
(0.7 |
) |
|
$ |
78.8 |
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Earnings per share: |
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|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.01 |
) |
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$ |
1.15 |
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Diluted |
|
$ |
(0.01 |
) |
|
$ |
1.12 |
|
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Weighted average shares outstanding: |
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|
|
|
|
|
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Basic |
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|
73.0 |
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|
68.6 |
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Diluted |
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|
73.0 |
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|
70.4 |
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7
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Consolidated Balance Sheets (Unaudited) |
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(in millions) |
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September 30, |
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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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$ |
93.3 |
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$ |
110.9 |
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Marketable investment securities |
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74.2 |
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|
|
69.7 |
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Prepaid expenses |
|
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11.5 |
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9.4 |
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Inventory |
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35.9 |
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|
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34.3 |
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Trade accounts receivable |
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|
119.1 |
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|
|
99.5 |
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Prepaid taxes |
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|
3.6 |
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— |
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Other receivables |
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4.3 |
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3.8 |
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Total current assets |
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341.9 |
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327.6 |
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Property, plant and equipment, net |
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60.0 |
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43.2 |
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Long-term marketable investment securities |
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|
24.2 |
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30.7 |
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Intangibles, net |
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|
734.2 |
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455.2 |
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Goodwill |
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|
413.3 |
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|
318.6 |
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Total assets |
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$ |
1,573.6 |
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$ |
1,175.3 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
23.8 |
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$ |
26.0 |
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Accrued liabilities |
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76.4 |
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68.3 |
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Short-term contingent consideration |
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5.3 |
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5.3 |
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Deferred revenue |
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2.5 |
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2.6 |
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Total current liabilities |
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|
108.0 |
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|
102.2 |
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Unrecognized tax benefits |
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|
24.6 |
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24.9 |
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Other long-term liabilities |
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|
6.3 |
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6.3 |
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Contingent consideration |
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|
9.6 |
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|
9.2 |
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Long-term debt |
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|
258.0 |
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|
|
9.3 |
|
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Long-term deferred taxes |
|
|
64.9 |
|
|
|
57.3 |
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Total liabilities |
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|
471.4 |
|
|
|
209.2 |
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Commitments and contingencies |
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|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Common stock, 74.7 and 70.6 shares outstanding at September 30, 2018 and June 30, 2018 respectively |
|
|
0.7 |
|
|
|
0.7 |
|
|
Additional paid-in capital |
|
|
1,052.4 |
|
|
|
915.4 |
|
|
Accumulated other comprehensive loss |
|
|
(4.3 |
) |
|
|
(4.1 |
) |
|
Retained earnings |
|
|
53.4 |
|
|
|
54.1 |
|
|
Total Myriad Genetics, Inc. stockholders’ equity |
|
|
1,102.2 |
|
|
|
966.1 |
|
|
Non-Controlling Interest |
|
|
— |
|
|
|
— |
|
|
Total stockholders' equity |
|
|
1,102.2 |
|
|
|
966.1 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
1,573.6 |
|
|
$ |
1,175.3 |
|
8
|
Consolidated Statement of Cash Flows (Unaudited) |
|
|||||||
|
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
Three months ended |
|
|||||
|
|
|
September 30, |
|
|||||
|
|
|
2018 |
|
|
2017 |
|
||
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
Net Income attributable to Myriad Genetics, Inc. stockholders |
|
$ |
(0.7 |
) |
|
|
78.8 |
|
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
18.3 |
|
|
|
13.2 |
|
|
Non-cash interest expense |
|
|
(1.3 |
) |
|
|
0.1 |
|
|
Loss (gain) on disposition of assets |
|
|
(1.0 |
) |
|
|
(0.1 |
) |
|
Share-based compensation expense |
|
|
7.7 |
|
|
|
6.4 |
|
|
Deferred income taxes |
|
|
2.7 |
|
|
|
4.7 |
|
|
Unrecognized tax benefits |
|
|
(2.6 |
) |
|
|
6.7 |
|
|
Change in fair value of contingent consideration |
|
|
(0.4 |
) |
|
|
(73.2 |
) |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
1.8 |
|
|
|
3.2 |
|
|
Trade accounts receivable |
|
|
(3.3 |
) |
|
|
(6.2 |
) |
|
Other receivables |
|
|
(0.3 |
) |
|
|
0.3 |
|
|
Inventory |
|
|
3.5 |
|
|
|
3.3 |
|
|
Prepaid taxes |
|
|
(3.6 |
) |
|
|
(8.9 |
) |
|
Accounts payable |
|
|
(8.4 |
) |
|
|
0.4 |
|
|
Accrued liabilities |
|
|
(4.4 |
) |
|
|
(5.8 |
) |
|
Deferred revenue |
|
|
(0.2 |
) |
|
|
0.6 |
|
|
Net cash provided by operating activities |
|
|
7.8 |
|
|
|
23.5 |
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(1.3 |
) |
|
|
(1.6 |
) |
|
Acquisitions, net of cash acquired |
|
|
(279.6 |
) |
|
|
— |
|
|
Purchases of marketable investment securities |
|
|
(14.4 |
) |
|
|
(31.5 |
) |
|
Proceeds from maturities and sales of marketable investment securities |
|
|
16.3 |
|
|
|
17.9 |
|
|
Net cash used in investing activities |
|
|
(279.0 |
) |
|
|
(15.2 |
) |
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
Net proceeds from common stock issued under share-based compensation plans |
|
|
2.1 |
|
|
|
1.7 |
|
|
Net proceeds from revolving credit facility |
|
|
290.0 |
|
|
|
— |
|
|
Repayment of revolving credit facility |
|
|
(40.0 |
) |
|
|
(25.0 |
) |
|
Net cash provided by (used in) financing activities |
|
|
252.1 |
|
|
|
(23.3 |
) |
|
Effect of foreign exchange rates on cash and cash equivalents |
|
|
1.5 |
|
|
|
0.5 |
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(17.6 |
) |
|
|
(14.5 |
) |
|
Cash and cash equivalents at beginning of the period |
|
|
110.9 |
|
|
|
102.4 |
|
|
Cash and cash equivalents at end of the period |
|
$ |
93.3 |
|
|
$ |
87.9 |
|
9
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company’s ability to become a trusted advisor transforming patient lives worldwide with pioneering diagnostics; the Company’s expectation that the issues impacting revenue for Genesight and prenatal testing are transitory; the Company’s ability to realize synergies from the Counsyl acquisition, continue to grow new product volumes, and secure additional new product coverage decisions, the Company’s ability to accelerate revenue growth and profitability ; the Company’s expectation regarding acceptance of the landmark GUIDED study in the fiscal second quarter of 2019; the Company’s expectation that results of a study demonstrating the minimally important difference in Vectra scores in Clinical Rheumatology will form the basis of the future Vectra medical management tool on the test report; estimates of additional covered commercial lives as a result of the positive coverage decision by Blue Shield of California for Prolaris; the Company’s fiscal year 2019 and fiscal second-quarter 2019 financial guidance for revenue, GAAP diluted earnings per share, and adjusted earnings per share under the caption “Fiscal Year 2019 and Fiscal Second-Quarter 2019 Financial Guidance”; and the Company’s strategic imperatives 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 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
10
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 Counsyl, 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.
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: Changes in effective tax rate based upon ASU 2016-09 and the deferred tax impact of transaction costs |
|
|
• |
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 months ended September 30, 2018 |
|
|
|
|
|
|
|
|
|
(Unaudited data in millions, except per share amount) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|||||
|
|
|
Sep 30, 2018 |
|
|
Sep 30, 2017 |
|
||
|
Revenue |
|
$ |
202.3 |
|
|
$ |
178.8 |
|
|
GAAP Cost of molecular diagnostic testing |
|
|
42.3 |
|
|
|
36.2 |
|
|
GAAP Cost of pharmaceutical and clinical services |
|
|
7.4 |
|
|
|
6.8 |
|
|
Equity Compensation |
|
|
(0.2 |
) |
|
|
(0.3 |
) |
|
Elevate 2020 costs |
|
|
(3.1 |
) |
|
|
— |
|
|
Non-GAAP COGS |
|
$ |
46.4 |
|
|
$ |
42.7 |
|
|
Non-GAAP Gross Margin |
|
|
77 |
% |
|
|
76 |
% |
|
GAAP Research and Development |
|
$ |
21.1 |
|
|
$ |
17.8 |
|
|
Acquisition - amortization of intangible assets |
|
|
(0.1 |
) |
|
|
(0.1 |
) |
|
Equity compensation |
|
|
(1.2 |
) |
|
|
(0.8 |
) |
|
Elevate 2020 costs |
|
|
(0.6 |
) |
|
|
(0.1 |
) |
|
Non-GAAP R&D |
|
$ |
19.2 |
|
|
$ |
16.8 |
|
|
GAAP Contingent Consideration |
|
$ |
0.4 |
|
|
$ |
(73.2 |
) |
|
Potential future consideration related to acquisitions |
|
|
(0.4 |
) |
|
|
73.2 |
|
|
Non-GAAP Contingent Consideration |
|
$ |
— |
|
|
$ |
— |
|
|
GAAP Selling, General and Administrative |
|
$ |
129.9 |
|
|
$ |
107.2 |
|
|
Acquisition - Integration related costs |
|
|
(9.6 |
) |
|
|
— |
|
|
Acquisition - amortization of intangible assets |
|
|
(13.2 |
) |
|
|
(9.1 |
) |
|
Equity compensation |
|
|
(6.3 |
) |
|
|
(5.3 |
) |
|
Elevate 2020 costs |
|
|
(1.2 |
) |
|
|
(1.2 |
) |
|
Non-GAAP SG&A |
|
$ |
99.6 |
|
|
$ |
91.6 |
|
|
GAAP Operating Income |
|
$ |
1.2 |
|
|
$ |
84.0 |
|
|
Acquisition - Integration related costs |
|
|
9.6 |
|
|
|
— |
|
|
Acquisition - amortization of intangible assets |
|
|
13.3 |
|
|
|
9.2 |
|
|
Equity compensation |
|
|
7.7 |
|
|
|
6.4 |
|
|
Elevate 2020 costs |
|
|
4.9 |
|
|
|
1.3 |
|
|
Potential future consideration related to acquisitions |
|
|
0.4 |
|
|
|
(73.2 |
) |
|
Non-GAAP Operating Income |
|
$ |
37.1 |
|
|
$ |
27.7 |
|
|
Non-GAAP Operating Margin |
|
|
18 |
% |
|
|
15 |
% |
|
GAAP Net Income Attributable to Myriad Genetics, Inc. Stockholders |
|
$ |
(0.7 |
) |
|
$ |
78.8 |
|
|
Acquisition - Integration related costs |
|
|
9.6 |
|
|
|
— |
|
|
Acquisition - amortization of intangible assets |
|
|
13.3 |
|
|
|
9.2 |
|
|
Equity compensation |
|
|
7.7 |
|
|
|
6.4 |
|
|
Elevate 2020 costs |
|
|
4.9 |
|
|
|
1.3 |
|
|
Potential future consideration related to acquisitions |
|
|
0.4 |
|
|
|
(73.2 |
) |
|
Deferred tax impact of non-GAAP adjustments |
|
|
2.7 |
|
|
|
0.3 |
|
|
Tax effect associated with non-GAAP adjustments |
|
|
(5.1 |
) |
|
|
(2.3 |
) |
|
Non-GAAP Net Income |
|
$ |
32.8 |
|
|
$ |
20.5 |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Diluted EPS |
|
$ |
(0.01 |
) |
|
$ |
1.12 |
|
|
Non-GAAP Diluted EPS |
|
$ |
0.43 |
|
|
$ |
0.29 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares outstanding |
|
|
77.0 |
|
|
|
70.4 |
|
13
|
Free Cash Flow Reconciliation |
|
|
|
|
|
|
|
|
|
(Unaudited data in millions) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|||||
|
|
|
Sep 30, 2018 |
|
|
Sep 30, 2017 |
|
||
|
|
|
|
|
|
|
|
|
|
|
GAAP cash flow from operations |
|
$ |
7.8 |
|
|
$ |
23.5 |
|
|
Capital expenditures |
|
|
(1.3 |
) |
|
|
(1.6 |
) |
|
Free cash flow |
|
$ |
6.5 |
|
|
$ |
21.9 |
|
|
Elevate 2020 costs |
|
|
4.7 |
|
|
|
1.3 |
|
|
Acquisition - Integration related costs |
|
|
8.1 |
|
|
|
— |
|
|
Tax effect associated with non-GAAP adjustments |
|
|
(2.9 |
) |
|
|
(0.4 |
) |
|
Non-GAAP Free cash flow |
|
$ |
16.4 |
|
|
$ |
22.8 |
|
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.
|
|
Fiscal Year 2019 |
|
|
|
Diluted net income per share |
|
|
|
|
GAAP diluted net income per share |
$0.40- $0.45 |
|
|
|
Stock Based Compensation Expense |
|
0.30 |
|
|
Acquisition - amortization of intangible assets |
|
0.80 |
|
|
One-time expenses |
|
0.20 |
|
|
Non-GAAP diluted net income per share |
$1.70 - $1.75 |
|
|
|
|
Fiscal Second-Quarter 2019 |
|
|
|
Diluted net income per share |
|
|
|
|
GAAP diluted net income per share |
$0.06 - $0.08 |
|
|
|
Stock Based Compensation Expense |
|
0.08 |
|
|
Acquisition - amortization of intangible assets |
|
0.20 |
|
|
One-time expenses |
|
0.02 |
|
|
Non-GAAP diluted net income per share |
$0.36 - $0.38 |
|
|
Myriad Genetics Fiscal First-Quarter 2019 Earnings Call 11/06/2018 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 2019 GAAP diluted earnings per share $0.40 - $0.45 Acquisition – amortization of intangible assets $0.80 Stock based compensation expense $0.30 Adjustments to GAAP financial measures $0.20 Non-GAAP diluted earnings per share $1.70 - $1.75 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 2019 First-Quarter Financial Results 1Q19 Actual Results 1Q18 Actual Results YoY Change Revenue (in mil.) $202.3 $178.8 13% GAAP EPS ($0.01) $1.12 NM Adjusted EPS $0.43 $0.29 48% Organic Adjusted EPS* $0.52 $0.29 79% Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. *Excludes $0.09 of dilution from the Counsyl acquisition in the fiscal first quarter
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 a solid hereditary cancer foundation
Solid Hereditary Cancer Foundation Seven Quarters of YoY Volume Growth With Stable Pricing Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Hereditary Cancer Revenue 7 sequential quarters with YoY volume growth 4 sequential quarters with stable pricing Double-digit volume growth from patients with less severe family histories due to riskScore™ Filed supplementary PMA for BRACAnalsysis CDx in first-line maintenance for ovarian cancer 2nd FDA approval for BRACAnalysis® CDx in met BC with Pfizer’s drug TALZENNA™ New research collaboration with Pfizer in neo-adjuvant TNBC
Record GeneSight Ordering Physicians Continued Strong Volume Trends With 28% Year-Over-Year Growth Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. 28% Growth GeneSight Volume Ordering Doctors Over 15,500 ordering doctors in 4Q18 35% Growth
Continued Strong Prenatal Volume Trends Significant Opportunity for Sales Synergies in 2H FY19 Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Prenatal Test Volume 16% YoY Volume Growth
Advances in Reimbursement Coverage For New Products New Product Reimbursement 1.6B in Potential Revenue Current U.S. Coverage GeneSight GUIDED study acceptance expected in Q2 FY19 GeneSight IMPACT and Optum Health studies published Blue Shield of California covers Prolaris increasing total commercial lives to 24 million Received draft LCD from Medicare for myPath Melanoma Received positive Bendcare guidelines for Vectra Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Reimbursed Addressable Market (RAM) RAM $240M $330M $720M $300M $4M
Continued Expansion in Prolaris Reimbursement 9 Commercial Payers Now Cover the Test Totaling 24 Million Lives 225 Sales Reps 80 Sales Reps Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Commercial Insurers 24 million commercial lives under coverage Medicare Low & Favorable Intermediate
International Developments Kit-Based Strategy With Restructuring to Global LDT Laboratory Revised NICE draft guidance document on breast cancer prognostics recommends EndoPredict as one of three diagnostic tests – final guidelines anticipated by end of CY18 All laboratory developed tests expected to be transitioned to SLC by end of CY18 resulting in closing of Munich laboratory Late-stage discussion with German clinic buyer Filing for regulatory approval in Japan for HBOC with BRACAnalysis – would be only approved test in 3.3M patient market Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Improve Profitability With Elevate 2020 Adjusted OM Improves 550 BP Since Start of Elevate 2020 Organic Total Expenses ($M) FY18 Targeted Savings = $17M Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Organic Adjusted Operating Margin 18.5% 24.0%
FY 2019 First-Quarter Revenue By Product Product 1Q19 1Q18 YoY Growth Hereditary Cancer $116.3 $117.0 (1%) GeneSight $29.3 $28.8 2% Prenatal Testing $18.1 $0.0 NM Vectra $13.0 $14.0 (7%) Prolaris $6.2 $3.9 59% EndoPredict $2.4 $1.8 33% Other $3.7 $1.9 95% Total Molecular Diagnostic Revenue $189.0 $167.4 13% Pharmaceutical & Clinical Services $13.3 $11.4 17% Total Revenue $202.3 $178.8 13% (in millions) Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Fiscal First-Quarter Financial Results Adjusted Earnings Per Share Increase 48% Over Q1 FY2018 GAAP Results Adjusted Results 1Q19 1Q18 YoY Growth 1Q19 1Q18 YoY Growth Total Revenue $202.3 $178.8 13% $202.3 $178.8 13% Gross Profit $152.6 $135.8 12% $155.9 $136.1 15% Gross Margin 75.4% 76.0% -160 bps 77.1% 76.1% +100 bps Operating Income $1.2 $84.0 (99%) $37.1 $27.7 34% Operating Margin 0.6% 47.0% -4640 bps 18.3% 15.5% +280 bps Net Income ($0.7) $78.8 NM $32.8 $20.5 60% EPS ($0.01) $1.12 NM $0.43 $0.29 48% Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
FY19 and 2Q19 Financial Guidance Metric Fiscal Year 2019 2Q19 Revenue $855 to $865 million $216 to $218 million GAAP Diluted EPS $0.40 to $0.45 $0.06 to $0.08 Adjusted EPS $1.70 to $1.75 $0.36 to $0.38 Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Potential Upside Drivers to Guidance Reimbursement and Counsyl Revenue Synergies Material Opportunity GeneSight commercial payer coverage decisions and expanded Medicare LCD Revenue synergies from the Counsyl acquisition in the second half of fiscal year 2019 Return to in-network status with UNH for prenatal tests Higher than anticipated hereditary cancer revenue due to Pfizer met BC launch, FDA approval for BRACAnalysis CDx in first-line maintenance for ovarian cancer, and Japanese HBOC/CDx testing Average risk coverage for NIPS; improved reimbursement for expanded carrier screening Incremental reimbursement for myPath Melanoma, Prolaris, Vectra and EndoPredict Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Almost ¼ of Women in OBGYN Practices Meet Guidelines Previous Market Estimates Likely Understate True Market Size Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. 23.8% of women met NCCN criteria for hereditary cancer testing Source: DeFrancesco et al. Hereditary Cancer Risk Assessment and Genetic Testing in Community Setting, Obstetrics & Gynecology 2018
Adding HOXB13 Gene to MyRisk Hereditary Cancer Panel Important Gene For Determining Hereditary Prostate Cancer Risk Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. HOXB13 HOXB13 Clinical Implications: Men with a deleterious variant have up to a 52% lifetime risk of prostate cancer Clinical Recommendations: More frequent screening for prostate cancer
Study Highlights Importance of Variant Reclassification Program Key Competitive Differentiator for Myriad’s myRisk Hereditary Cancer Test Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. 1.45 Million Patients Tested Over 10 Years 25% of VUS reclassified leading to 59,995 amended reports 9% Deleterious Variants Source: Mersch et al. Prevalence of Variant Reclassification Following Hereditary Cancer Genetic Testing, JAMA 2018 LitVIEW™ inSITE™ Pheno™ MuCo™ 3D Structural Analysis
Optum Study Strengthens GeneSight Health Economic Data First Year Savings >$6,000 in Patients With Major Depressive Disorder Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. GeneSight TAU Savings All Psychiatry Patients $17,627 $23,132 $5,505 (p=0.0004) Patients With MDD $18,741 $24,971 $6,050 (p=0.009) Savings do not include productivity improvements 37% 13% 50%
Robust Clinical Evidence Supporting GeneSight GUIDED Study Provides Level One Evidence Supporting Clinical Utility Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. p=0.013 p=0.007 Outcome Measures at Week 8 50% improvement in remission n=560 n=607 p=0.107 30% improvement in response 14% improvement in symptoms
Patients Switching From Red Medications Highly Statistically Significant Improvement in All Endpoints Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Baseline Week 8 Baseline Week 8 Remission Symptom Improvement Response Switch No Switch Switch No Switch Switch No Switch Compares 57% of patients that switched vs. 43% of patients that did not
Significant Opportunity for Revenue Synergies Combined Sales Teams Will Triple Physician Reach in Women’s Health Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. 16,000 Women’s Health Call Points 37,000 OBGYNs in Clinical Practice 9,000 Unique Ordering Physicians 3,500 Unique Ordering Physicians 1,500 Overlap Physicians 23,000 OBGYNs Not Targeted
Reimbursement Catalysts for Foresight and Prelude New Coverage Decisions and Medical Policy Changes Could Increase ASP Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Medicare announces preliminary pricing for CPT code 81412 at $2,448 New clinical utility study published in Genetics in Medicine will help with guideline changes Evidence Street announces positive recommendation on average risk testing Two BCBS plans update medical policies to cover average risk Anticipate ACOG guidelines for average risk women
Vectra Study on Minimally Important Difference Important for Establishing Medical Management Tool on Test Report Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Medicare Issues Favorable Draft LCD for myPath Melanoma Creates Opportunity for myPath Melanoma Revenue in FY20 225 Sales Reps 80 Sales Reps Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. Commercial Insurers 7 commercial insurers cover the test Medicare *Assumes favorable coverage decision from Medicare in FY19 300,000 indeterminate skin biopsies in the U.S. every year = $450M market
AAD Issues Positive Guidelines for myPath Melanoma Important Step to Establish Broad Reimbursement Coverage Copyright © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com. myPath Melanoma is the only gene expression profiling test cited in the guidelines *Swetter et al – Journal of the American Academy of Dermatology, October 2018
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 © 2018 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.