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): May 2, 2017
MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 0-26642 | 87-0494517 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(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. ☐
| ITEM 2.02 | Results of Operations and Financial Condition. |
On May 2, 2017, Myriad Genetics, Inc. (“Myriad”) announced its financial results for the three months ended December 31, 2016. The earnings release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
| ITEM 7.01 | Regulation FD Disclosure. |
On its earnings conference call for the three months ended March 31, 2017, Myriad also delivered a slide presentation, which is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. [The slide presentation will also be available under the “Investors –Events & Presentations” section of Myriad’s website at www.myriad.com.]
FORWARD-LOOKING STATEMENTS
Exhibits 99.1 and 99.2 contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our business, goals, strategy and financial and operational outlook. These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K, which has been filed
with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in the exhibits is as of the date of the exhibits, and Myriad undertakes no duty to update this information unless required by law.
| ITEM 9.01 | Financial Statements and Exhibits. |
(d)
| Exhibit Number |
Description | |
| 99.1 | Earnings release dated May 2, 2017 for the three months ended March 31, 2017. | |
| 99.2 | Earnings call slide presentation dated May 2, 2017 for the three months ended March 31, 2017. | |
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.
SIGNATURES
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.
| MYRIAD GENETICS, INC. | ||||||
| Date: May 2, 2017 | By: | /s/ R. Bryan Riggsbee | ||||
| R. Bryan Riggsbee | ||||||
| Executive Vice President, Chief Financial Officer | ||||||
EXHIBIT INDEX
| Exhibit Number |
Description | |
| 99.1 | Earnings release dated May 2, 2017 for the three months ended March 31, 2017. | |
| 99.2 | Earnings call slide presentation dated May 2, 2017 for the three months ended March 31, 2017. | |
Exhibit 99.1
|
|
News Release | |||||||
| Media Contact: | Ron Rogers | Investor Contact: | Scott Gleason | |||||
| (801) 584-3065 | (801) 584-1143 | |||||||
| rrogers@myriad.com | sgleason@myriad.com | |||||||
Myriad Genetics Reports Fiscal Third-Quarter 2017 Financial Results
| • | Third-Quarter 2017 Total Revenues of $196.9 Million |
| • | Third-Quarter 2017 GAAP Diluted EPS of $0.06 and Adjusted EPS of $0.27 |
| • | Company Increases Annual Revenue Guidance, Narrows Adjusted EPS Guidance |
SALT LAKE CITY, UTAH, May 2, 2017 – Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and personalized medicine, today announced financial results for its fiscal third-quarter 2017, provided an update on recent business highlights and updated its fiscal year 2017 financial guidance.
“We were very encouraged to see sequential growth in hereditary cancer testing volumes for the second consecutive quarter,” said Mark C. Capone, president and CEO, Myriad Genetics. “Coupled with meaningful sequential volume growth in all of our major pipeline tests including GeneSight, Vectra DA, Prolaris, and EndoPredict, we believe we are rapidly approaching an important inflection in our business where our new products will drive accelerated revenue growth and profitability.”
Financial Highlights
| • | The following table summarizes the financial results and product revenue for our fiscal third-quarter 2017: |
| Revenue |
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| Fiscal Third-Quarter | ||||||||||||
| ($ in millions) | 2017 | 2016 | % Change |
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| Molecular diagnostic testing revenue |
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| Hereditary cancer testing revenue |
$ | 140.8 | $ | 156.3 | (10 | %) | ||||||
| GeneSight testing revenue |
23.9 | NA | NM | |||||||||
| Vectra DA testing revenue |
11.2 | 12.3 | (9 | %) | ||||||||
| Prolaris testing revenue |
3.4 | 5.2 | * | (35 | %) | |||||||
| EndoPredict testing revenue |
2.3 | 1.1 | 109 | % | ||||||||
| Other testing revenue |
3.6 | 2.5 | 44 | % | ||||||||
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| Total molecular diagnostic testing revenue |
185.2 | 177.4 | 4 | % | ||||||||
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| Pharmaceutical and clinical service revenue |
11.7 | 13.1 | (11 | %) | ||||||||
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| Total Revenue |
$ | 196.9 | $ | 190.5 | 3 | % | ||||||
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| Income Statement |
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| Fiscal Third-Quarter | ||||||||||||
| ($ in millions) | 2017 | 2016 | % Change |
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| Total Revenue |
$ | 196.9 | $ | 190.5 | 3 | % | ||||||
| Gross Profit |
152.6 | 150.3 | 2 | % | ||||||||
| Gross Margin |
77.5 | % | 78.9 | % | ||||||||
| Operating Expenses |
139.7 | 107.7 | 30 | % | ||||||||
| Operating Income |
12.9 | 42.6 | (70 | %) | ||||||||
| Operating Margin |
6.6 | % | 22.4 | % | ||||||||
| Adjusted Operating Income |
24.0 | 45.8 | (48 | %) | ||||||||
| Adjusted Operating Margin |
12.2 | % | 24.0 | % | ||||||||
| Net Income |
4.2 | 34.5 | (88 | %) | ||||||||
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| Diluted EPS |
0.06 | 0.47 | (87 | %) | ||||||||
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| Adjusted EPS |
$ | 0.27 | $ | 0.41 | (34 | %) | ||||||
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* Included Medicare retrospective payments
2
Business Highlights
| • | myRisk® Hereditary Cancer |
| • | Hereditary cancer volumes grew on a sequential basis for the second consecutive quarter. |
| • | A publication in The Oncologist by researchers at Northwestern University compared 4,250 variants from ClinVar to those from Myriad Genetics. In the study, only 73 percent of the classifications in ClinVar were consistent with Myriad classifications with 27 percent discordant. In addition, it was shown that Myriad could definitely classify up to 60 percent of the variants of uncertain significance from other laboratories. |
| • | GeneSight® |
| • | Volume grew 44 percent year-over-year to more than 60,000 tests performed in the fiscal third-quarter. |
| • | Completed enrollment ahead of schedule in a 1,200 patient clinical utility study evaluating GeneSight in patients with treatment resistant depression. The company anticipates top line data by the end of calendar year 2017. |
| • | Published data in Clinical Therapeutics which evaluated 2,168 patients whose treatment was either congruent or non-congruent with the GeneSight test result which demonstrated health savings of $3,998 for primary care physicians and $1,308 for patients treated by psychiatrists after paying for the cost of the test. |
| • | Completed a payer demonstration project using the Optum healthcare informatics platform from United Health that demonstrated substantial cost savings associated with the use of GeneSight. Initiated similar demonstration projects with Humana and HealthCore, a subsidiary of Anthem Blue Cross Blue Shield. |
| • | Launched highly a successful pilot sales program for GeneSight in the preventive care market with the average sales territory already generating a 300 sample annual run rate. |
| • | Vectra® DA |
| • | Volumes increased five percent sequentially with approximately 38,500 tests performed. |
| • | Creaky Joints, a leading advocacy group for arthritis patients added Vectra DA to its professional guidelines. This builds upon the recent addition of Vectra DA to the United Rheumatology guidelines, a physician guideline body comprising approximately 10 percent of practicing rheumatologists. |
3
| • | Prolaris® |
| • | Volumes grew 17 percent year-over-year and nine percent sequentially with approximately 5,100 tests ordered in the third quarter. |
| • | The comment period ended on a draft local coverage determination from Palmetto GBA for favorable-intermediate patients, a new indication that would represent a market expansion of approximately 30,000 patients per year in the United States. Prolaris is the only test to receive proposed Medicare coverage in this patient population. |
| • | At the upcoming American Urology Association meeting, Myriad will be presenting a 767 patient study that demonstrated the ability of Prolaris to predict metastases from biopsy samples with a high degree of statistical significance. |
| • | EndoPredict® |
| • | Revenues grew 109 percent year-over-year to $2.3 million in the fiscal third-quarter. |
| • | Launched EndoPredict in the United States at the end of the fiscal third-quarter. |
| • | In aggregate, Myriad has now received positive coverage decisions from payers in the United States representing 83 million lives. |
| • | myPath® Melanoma |
| • | Myriad’s third clinical validation study, which demonstrated myPath Melanoma was able to differentiate melanoma from benign nevi with 95 percent diagnostic accuracy, was published in Cancer Epidemiology. |
| • | Myriad has submitted its reimbursement dossier for myPath Melanoma to Medicare and private payers. |
| • | Companion Diagnostics |
| • | AstraZeneca announced that olaparib met its primary endpoint in BRCA positive, HER2- metastatic breast cancer in the OlympiAD study, demonstrating a statistically significant benefit in progression free survival. This represents a potential 60,000 patient per year market for BRACAnalysis CDx as a companion diagnostic. |
| • | Myriad signed a research collaboration with BeiGene which is a global pharmaceutical company developing the PARP inhibitor BGB-290 in the United States. |
| • | Signed a commercial collaboration with Clovis Oncology to perform BRACAnalysis CDx testing. Myriad is now performing companion diagnostic testing for every major company developing a PARP inhibitor. |
4
| • | Submitted our regulatory filing in Japan for BRACAnalysis CDx as the companion diagnostic for Lynparza in conjunction with our collaboration with AstraZeneca. |
| • | International |
| • | International revenue grew 41 percent year-over-year and comprised five percent of total revenue in the fiscal third-quarter. |
| • | International EndoPredict revenue grew 109 percent year-over-year, largely as a result of recent French and German reimbursement. |
Fiscal Year 2017 and Fiscal Fourth-Quarter 2017 Financial Guidance
Below is a table summarizing Myriad’s updated fiscal year 2017 and fiscal fourth-quarter 2017 financial guidance:
| Revenue | GAAP Diluted Earnings Per Share |
Adjusted Earnings Per Share |
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| Fiscal Year 2017 |
$763-$765 million |
$ | 0.23-$0.25 | $ | 1.01-$1.03 | |||||
| Fiscal Fourth-Quarter 2017 |
$192-$194 million |
$ | 0.11-$0.13 | $ | 0.26-$0.28 | |||||
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These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today to discuss the fiscal third-quarter financial results, fiscal year 2017, and fiscal fourth-quarter 2017 financial guidance.
Conference Call and Webcast
A conference call will be held today, Tuesday, May 2, 2017, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal third-quarter, business developments and financial guidance. The dial-in number for domestic callers is (888) 225-2744. International callers may dial (303) 223-2690. All callers will be asked to reference reservation number 21849837. 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.
5
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 three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. 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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra DA, GeneSight, EndoPredict and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G
6
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS (Unaudited)
| (in millions, except per share amounts) |
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| Three months ended March 31, |
Nine months ended March 31, |
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Molecular diagnostic testing |
$ | 185.2 | $ | 177.4 | $ | 534.2 | $ | 532.0 | ||||||||
| Pharmaceutical and clinical services |
11.7 | 13.1 | 36.7 | 35.4 | ||||||||||||
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| Total revenue |
196.9 | 190.5 | 570.9 | 567.4 | ||||||||||||
| Costs and expenses: |
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| Cost of molecular diagnostic testing |
37.9 | 33.6 | 109.5 | 98.6 | ||||||||||||
| Cost of pharmaceutical and clinical services |
6.4 | 6.6 | 19.1 | 18.7 | ||||||||||||
| Research and development expense |
17.6 | 17.2 | 55.6 | 51.1 | ||||||||||||
| Selling, general, and administrative expense |
122.1 | 90.5 | 354.3 | 267.8 | ||||||||||||
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| Total costs and expenses |
184.0 | 147.9 | 538.5 | 436.2 | ||||||||||||
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| Operating income |
12.9 | 42.6 | 32.4 | 131.2 | ||||||||||||
| Other income (expense): |
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| Interest income |
0.3 | 0.3 | 0.9 | 0.5 | ||||||||||||
| Interest expense |
(1.5 | ) | — | (4.8 | ) | (0.2 | ) | |||||||||
| Change in the fair value of contingent consideration |
(5.2 | ) | — | (2.0 | ) | — | ||||||||||
| Other |
1.5 | 0.2 | (2.4 | ) | 0.2 | |||||||||||
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| Total other income (expense): |
(4.9 | ) | 0.5 | (8.3 | ) | 0.5 | ||||||||||
| Income before income tax |
8.0 | 43.1 | 24.1 | 131.7 | ||||||||||||
| Income tax provision |
3.8 | 8.6 | 15.2 | 29.7 | ||||||||||||
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| Net income |
$ | 4.2 | $ | 34.5 | $ | 8.9 | $ | 102.0 | ||||||||
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| Net loss attributable to non-controlling interest |
— | — | (0.1 | ) | — | |||||||||||
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| Net income attributable to Myriad Genetics, Inc. stockholders |
$ | 4.2 | $ | 34.5 | $ | 9.0 | $ | 102.0 | ||||||||
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| Earnings per share: |
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| Basic |
$ | 0.06 | $ | 0.49 | $ | 0.13 | $ | 1.46 | ||||||||
| Diluted |
$ | 0.06 | $ | 0.47 | $ | 0.13 | $ | 1.39 | ||||||||
| Weighted average shares outstanding: |
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| Basic |
68.1 | 70.9 | 68.1 | 70.1 | ||||||||||||
| Diluted |
68.3 | 73.5 | 68.5 | 73.2 | ||||||||||||
7
Consolidated Balance Sheets (Unaudited)
| (in millions) | ||||||||
| March 31, 2017 |
June 30, 2016 |
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| ASSETS | ||||||||
| Current assets: |
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| Cash and cash equivalents |
$ | 123.8 | $ | 68.5 | ||||
| Marketable investment securities |
48.3 | 90.5 | ||||||
| Prepaid expenses |
9.5 | 18.4 | ||||||
| Inventory |
47.4 | 38.3 | ||||||
| Trade accounts receivable, less allowance for doubtful accounts of $8.1 March 31, 2017 and $6.8 June 30, 2016 |
114.8 | 91.7 | ||||||
| Prepaid taxes |
0.1 | 3.8 | ||||||
| Other receivables |
4.4 | 3.3 | ||||||
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| Total current assets |
348.3 | 314.5 | ||||||
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| Property, plant and equipment, net |
53.0 | 58.3 | ||||||
| Long-term marketable investment securities |
53.4 | 79.9 | ||||||
| Intangibles, net |
498.1 | 227.5 | ||||||
| Goodwill |
315.0 | 195.3 | ||||||
| Other assets |
— | 5.0 | ||||||
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| Total assets |
$ | 1,267.8 | $ | 880.5 | ||||
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| LIABILITIES AND STOCKHOLDERS’ EQUITY |
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| Current liabilities: |
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| Accounts payable |
$ | 26.8 | $ | 21.1 | ||||
| Accrued liabilities |
64.0 | 49.5 | ||||||
| Short-term contingent consideration |
128.2 | — | ||||||
| Deferred revenue |
2.7 | 1.7 | ||||||
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| Total current liabilities |
221.7 | 72.3 | ||||||
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| Unrecognized tax benefits |
24.9 | 24.0 | ||||||
| Other long-term liabilities |
7.2 | 7.8 | ||||||
| Contingent consideration |
14.3 | 10.4 | ||||||
| Long-term debt |
167.1 | — | ||||||
| Long-term deferred taxes |
84.7 | 17.9 | ||||||
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| Total liabilities |
519.9 | 132.4 | ||||||
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| Commitments and contingencies |
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| Stockholders’ equity: |
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| Common stock, 68.1 and 69.1 shares outstanding at March 31, 2017 and June 30, 2016 respectively |
0.7 | 0.7 | ||||||
| Additional paid-in capital |
839.5 | 830.1 | ||||||
| Accumulated other comprehensive loss |
(10.6 | ) | (9.5 | ) | ||||
| Accumulated deficit |
(81.4 | ) | (73.2 | ) | ||||
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| Total Myriad Genetics, Inc. stockholders’ equity |
748.2 | 748.1 | ||||||
| Non-Controlling Interest |
(0.3 | ) | — | |||||
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| Total stockholders’ equity |
747.9 | 748.1 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 1,267.8 | $ | 880.5 | ||||
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8
Consolidated Statement of Cash Flows (Unaudited)
| (in millions) | ||||||||
| Nine months ended March 31, |
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| 2017 | 2016 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: |
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| Net income |
$ | 8.9 | 102.0 | |||||
| Adjustments to reconcile net income to net cash provided by operating activities: |
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| Depreciation and amortization |
35.0 | 20.0 | ||||||
| Non-cash interest expense |
0.4 | — | ||||||
| Gain on disposition of assets |
(0.2 | ) | (0.4 | ) | ||||
| Share-based compensation expense |
22.7 | 23.9 | ||||||
| Impairment of cost basis investment |
2.4 | — | ||||||
| Bad debt expense |
27.3 | 23.5 | ||||||
| Loss on extinguishment of debt |
1.3 | — | ||||||
| Deferred income taxes |
2.0 | 31.5 | ||||||
| Unrecognized tax benefits |
0.9 | (2.4 | ) | |||||
| Change in fair value of contingent consideration |
2.0 | — | ||||||
| Changes in assets and liabilities: |
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| Prepaid expenses |
10.9 | (8.7 | ) | |||||
| Trade accounts receivable |
(40.3 | ) | (28.7 | ) | ||||
| Other receivables |
(3.2 | ) | (1.0 | ) | ||||
| Inventory |
(6.5 | ) | (0.2 | ) | ||||
| Prepaid taxes |
3.6 | (27.7 | ) | |||||
| Accounts payable |
2.0 | (6.9 | ) | |||||
| Accrued liabilities |
(0.6 | ) | 2.9 | |||||
| Deferred revenue |
1.0 | — | ||||||
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| Net cash provided by operating activities |
69.6 | 127.8 | ||||||
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| CASH FLOWS FROM INVESTING ACTIVITIES |
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| Capital expenditures |
(5.4 | ) | (2.8 | ) | ||||
| Acquisitions, net of cash acquired |
(216.1 | ) | — | |||||
| Sale of cost basis investment |
2.6 | — | ||||||
| Purchases of marketable investment securities |
(74.6 | ) | (131.4 | ) | ||||
| Proceeds from maturities and sales of marketable investment securities |
142.9 | 86.6 | ||||||
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| Net cash used in investing activities |
(150.6 | ) | (47.6 | ) | ||||
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| CASH FLOWS FROM FINANCING ACTIVITIES: |
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| Net proceeds for common stock issued under share-based compensation plans |
1.3 | 85.9 | ||||||
| Net proceeds from revolving credit facility |
204.0 | — | ||||||
| Net proceeds from term loan |
199.0 | — | ||||||
| Repayment of term loan |
(200.0 | ) | — | |||||
| Repayment of revolving credit facility |
(37.0 | ) | ||||||
| Fees paid for extinguishment of debt |
(0.6 | ) | — | |||||
| Repurchase and retirement of common stock |
(31.6 | ) | (107.9 | ) | ||||
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|
|
|||||
| Net cash provided by (used in) financing activities |
135.1 | (22.0 | ) | |||||
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|
|
|||||
| Effect of foreign exchange rates on cash and cash equivalents |
1.2 | (1.8 | ) | |||||
| Net increase in cash and cash equivalents |
55.3 | 56.4 | ||||||
| Cash and cash equivalents at beginning of the period |
68.5 | 64.1 | ||||||
|
|
|
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|
|||||
| Cash and cash equivalents at end of the period |
$ | 123.8 | $ | 120.5 | ||||
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|
|||||
9
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company’s anticipated volumes, revenue and profitability from existing and new products; the Company’s belief that it is rapidly approaching an important inflection in its business where its new products will drive accelerated revenue growth and profitability; the Company’s expectation of receiving top line data from a 1,200 patient clinical utility study evaluating GeneSight in patients with treatment resistant depression by the end of calendar year 2017; the potential market expansion of approximately 30,000 patients per year for Prolaris based on Palmetto GBA’s draft coverage determination; the potential 60,000 patient per year market for BRACAnalysis CDx as a companion diagnostic to olaparib; the Company’s anticipated study presentation at the upcoming American Urology Association meeting; the Company’s fiscal fourth-quarter guidance of total revenue of $192 to $194 million, diluted earnings per share of $0.11 to $0.13, and adjusted earnings per share of $0.26 to $0.28, and the Company’s updated fiscal full year guidance of total revenue of $763 to $765 million, diluted earnings per share of $0.23 to $0.25, and adjusted earnings per share of $1.01 to $1.03, as further discussed under the caption “Fiscal Year 2017 and Fiscal Fourth-Quarter 2017 Financial Guidance”; and the Company’s strategic directives under the caption “About Myriad Genetics.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of 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
10
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, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual report on Form 10-K for the fiscal year ended June 30, 2016, 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.
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. |
11
| • | Acquisition – integration related costs: Costs related to closing and integration of acquired companies |
| • | Tax impact related to equity compensation – Changes in effective tax rate based upon ASU 2016-09 |
| • | Tax expense associated with R&D tax credit reserves – One time net benefits associated with the release of R&D tax credit reserves. |
| • | Potential future consideration related to acquisitions – Non-cash expenses related to valuation adjustments of earn-out and milestone payments tied to recent acquisitions |
| • | One-time debt restructuring charges – Charges related to the restructuring of the company’s debt from a one-year term loan to a revolving credit facility |
| • | One-time non-deductible costs – One-time non-deductible tax items |
| • | Impairment of Raindance Investment – One-time impairment charge associated with Myriad’s investment in Raindance Technologies |
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 Nine Months ended March 31, 2017 and 2016
(Unaudited data in millions, except per share amount)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| Mar 31, 2017 | Mar 31, 2016 | Mar 31, 2017 | Mar 31, 2016 | |||||||||||||
| Revenue |
196.9 | 190.5 | 570.9 | 567.4 | ||||||||||||
| GAAP Cost of molecular diagnostic testing |
$ | 37.9 | $ | 33.6 | $ | 109.5 | $ | 98.6 | ||||||||
| GAAP Cost of pharmaceutical and clinical services |
6.4 | 6.6 | 19.1 | 18.7 | ||||||||||||
| Acquisition - Integration related costs |
— | — | — | — | ||||||||||||
| Acquisition - amortization of intangible assets |
— | — | — | — | ||||||||||||
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| Non-GAAP COGS |
$ | 44.3 | $ | 40.2 | $ | 128.6 | $ | 117.3 | ||||||||
| Non-GAAP Gross Margin |
78 | % | 79 | % | 77 | % | 79 | % | ||||||||
| GAAP Research and Development |
$ | 17.6 | $ | 17.2 | $ | 55.6 | $ | 51.1 | ||||||||
| Acquisition - Integration related costs |
(0.1 | ) | — | (0.2 | ) | — | ||||||||||
| Acquisition - amortization of intangible assets |
— | (0.1 | ) | (0.2 | ) | (0.3 | ) | |||||||||
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| Non-GAAP R&D |
$ | 17.5 | $ | 17.1 | $ | 55.2 | $ | 50.8 | ||||||||
| GAAP Selling, General and Administrative |
$ | 122.1 | $ | 90.5 | $ | 354.3 | $ | 267.8 | ||||||||
| Acquisition - Integration related costs |
(1.8 | ) | — | (12.8 | ) | — | ||||||||||
| Acquisition - amortization of intangible assets |
(9.2 | ) | (3.1 | ) | (23.6 | ) | (9.2 | ) | ||||||||
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| Non-GAAP SG&A |
$ | 111.1 | $ | 87.4 | $ | 317.9 | $ | 258.6 | ||||||||
| GAAP Operating Income |
$ | 12.9 | $ | 42.6 | $ | 32.4 | $ | 131.2 | ||||||||
| Acquisition - Integration related costs |
1.9 | — | 13.0 | — | ||||||||||||
| Acquisition - amortization of intangible assets |
9.2 | 3.2 | 23.8 | 9.5 | ||||||||||||
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| Non-GAAP Operating Income |
$ | 24.0 | $ | 45.8 | $ | 69.2 | $ | 140.7 | ||||||||
| Non-GAAP Operating Margin |
12 | % | 24 | % | 12 | % | 25 | % | ||||||||
| GAAP Net Income Attributable to Myriad Gentics, Inc. Stockholders |
$ | 4.2 | $ | 34.5 | $ | 9.0 | $ | 102.0 | ||||||||
| Acquisition - Integration related costs |
1.9 | — | 13.0 | — | ||||||||||||
| Acquisition - amortization of intangible assets |
9.2 | 3.2 | 23.8 | 9.5 | ||||||||||||
| Tax impact related to equity compensation |
(0.1 | ) | (1.9 | ) | 2.9 | (12.4 | ) | |||||||||
| Tax expense associated with R&D tax credit reserves |
(6.0 | ) | — | (6.0 | ) | |||||||||||
| Earn out true-up |
5.2 | — | 0.6 | — | ||||||||||||
| One-time debt restructuring charges |
— | — | 1.3 | — | ||||||||||||
| One-time non-deductible costs |
(1.5 | ) | — | 2.7 | — | |||||||||||
| Impairment of Raindance Investment |
(0.1 | ) | — | 3.3 | — | |||||||||||
| Tax effect associated with non-GAAP adjustments |
(0.7 | ) | — | (4.9 | ) | — | ||||||||||
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|||||||||
| Non-GAAP Net Income |
$ | 18.1 | $ | 29.8 | $ | 51.7 | $ | 93.1 | ||||||||
| GAAP Diluted EPS |
$ | 0.06 | $ | 0.47 | $ | 0.13 | $ | 1.39 | ||||||||
| Non-GAAP Diluted EPS |
$ | 0.27 | $ | 0.41 | $ | 0.75 | $ | 1.27 | ||||||||
| Diluted shares outstanding |
68.3 | 73.5 | 68.5 | 73.2 | ||||||||||||
13
Free Cash Flow Reconciliation
(Unaudited data in millions)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| Mar 31, 2017 | Mar 31, 2016 | Mar 31, 2017 | Mar 31, 2016 | |||||||||||||
| GAAP cash flow from operations |
$ | 41.1 | $ | 45.9 | $ | 69.6 | $ | 127.8 | ||||||||
| Capital expenditures |
(1.5 | ) | (0.7 | ) | (5.4 | ) | (2.8 | ) | ||||||||
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| Free cash flow |
$ | 39.6 | $ | 45.2 | $ | 64.2 | $ | 125.0 | ||||||||
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|||||||||
| Acquisition - Integration related costs |
1.9 | — | 9.8 | — | ||||||||||||
| Cash paid at closing to Assurex vendors |
— | — | 6.8 | — | ||||||||||||
| Tax effect associated with non-GAAP adjustments |
(0.7 | ) | — | (6.4 | ) | — | ||||||||||
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|||||||||
| Non-GAAP Free cash flow |
$ | 40.8 | $ | 45.2 | $ | 74.4 | $ | 125.0 | ||||||||
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Reconciliation of GAAP to Non-GAAP for Fiscal Year 2017 and Fiscal Fourth-Quarter 2017 Financial Guidance
The Company’s future performance and financial results are subject to risks and uncertainties, and actual results could differ materially from guidance set forth below. Some of the factors that could affect the Company’s financial results are stated in the safe harbor statement of this press release. More information on potential factors that could affect the Company’s financial results are included under the heading “Risk Factors” contained in Item 1A in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in the Company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
| Fiscal Year 2017 | ||||
| Diluted net income per share |
||||
| GAAP diluted net income per share |
$ | 0.23 - $0.25 | ||
| Acquisition - amortization of intangible assets |
0.48 | |||
| Acquisition costs & one-time expenses |
0.30 | |||
|
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|
|||
| Non-GAAP diluted net income per share |
$ | 1.01 - $1.03 | ||
|
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|
|||
| Fiscal Fourth-Quarter 2017 |
||||
| Diluted net income per share |
||||
| GAAP diluted net income per share |
$ | 0.11 - $0.13 | ||
| Acquisition - amortization of intangible assets |
0.13 | |||
| Acquisition costs & one-time expenses |
0.02 | |||
|
|
|
|||
| Non-GAAP diluted net income per share |
$ | 0.26 - $0.28 | ||
|
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14
Myriad Genetics Fiscal Third-Quarter 2017 Earnings Call 05/02/2017 Exhibit 99.2
Forward Looking Statements Some of the information presented here today may contain projections or other forward-looking statements regarding future events or the future financial performance of the Company. These statements are based on management’s current expectations and the actual events or results may differ materially and adversely from these expectations. We refer you to the documents the Company files from time to time with the Securities and Exchange Commission, specifically, the Company’s annual reports on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in the Company’s projections or forward-looking statements. In this presentation, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. The Company’s financial measures under GAAP include substantial one-time charges related to its acquisitions and ongoing amortization expense related to acquired intangible assets that will be recognized over the useful lives of the assets and charges related to executive severance. Management believes that presentation of operating results that excludes these items provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP to non-GAAP financial guidance is provided below. Forward Looking Statements Non-GAAP Financial Measures Fiscal Year 2017 GAAP diluted earnings per share $0.23 - $0.25 Acquisition – amortization of intangible assets $0.48 Acquisition – one time charges $0.30 Non-GAAP diluted earnings per share $1.01 - $1.03 Fiscal Fourth-Quarter 2017 GAAP diluted earnings per share $0.11 - $0.13 Acquisition – amortization of intangible assets $0.13 Acquisition – one time charges $0.02 Non-GAAP diluted earnings per share $0.26 - $0.28 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/
Third Quarter FY2017 Financial Results Significantly Exceeded Expectations 3Q17 Actual Results 3Q16 Actual Results YoY Change Guidance Revenue $196.9 $190.5 3% $188 - $190 million GAAP EPS $0.06 $0.47 (87%) $0.08 - $0.10 Adjusted EPS $0.27 $0.41 (34%) $0.23 - $0.25 * Based on higher than anticipated closing costs in the quarter due to the earlier than expected closing of the Assurex acquisition
Key Accomplishments in 3Q17 Excellent Progress on Three Strategic Imperatives Strategic Imperative Accomplishment Continued Leadership in an Expanding Hereditary Cancer Market Grew hereditary cancer volume in seasonally challenging 3Q for first time in five years Oncology volume up sequentially for second quarter in a row Diversify Revenue with New Products Non-hereditary cancer testing reached 68% of volume and 28% of revenue GeneSight volume up 44% and revenue up 41% YoY Completed enrollment early in major prospective clinical utility study for GeneSight Vectra DA volumes increased 5% sequentially returning to sequential growth Prolaris volume up 9% sequentially breaking 20,000 annual run rate Presenting Prolaris study at AUA demonstrating the ability predict metastases BRACAnalysis CDx successful at selecting patients in metastatic breast cancer study Launched EndoPredict in U.S. market; over 83 million lives now covered Submitted myPath Melanoma reimbursement dossier to Medicare and commercial payers Grow Kit Products in Major International Geographies Grew revenue 41% year-over-year International revenue reached 5% of total revenue EndoPredict revenue grew 109% year-over-year Submitted our regulatory filing in Japan for BRACAnalysis CDx as the companion diagnostic for Lynparza in conjunction with our collaboration with AstraZeneca.
Fiscal Third-Quarter 2017 Revenue By Product Achieved Highest Revenue in Last Three Years Product 3Q17 3Q16 YoY Growth Hereditary Cancer $140.8 $156.3 (10%) GeneSight $23.9 NA* NM Vectra DA $11.2 $12.3 (9%) Prolaris $3.4 $5.2** (35%) EndoPredict $2.3 $1.1 109% Other $3.6 $2.5 44% Total Molecular Diagnostic Revenue $185.1 $177.4 4% Pharmaceutical & Clinical Services $11.7 $13.1 (11%) Total Revenue $196.9 $190.5 3% (in millions) * Prior to the completion of the Assurex Health acquisition ** Included Medicare retrospective payments
Fiscal Third-Quarter Financial Results 3Q17 3Q16 YoY Growth Total Revenue $196.9 $190.5 3% Gross Profit $152.6 $150.3 2% Gross Margin 77.5% 78.9% NM Operating Income $12.9 $42.6 (70%) Adjusted Operating Income $24.0 $45.8 (48%) Adjusted Operating Margin 12.2% 24.0% NM Net Income $4.2 $34.5 (88%) Diluted EPS $0.06 $0.47 (87%) Adjusted EPS $0.27 $0.41 (34%) (in millions except per share data)
4Q17 and FY17 Financial Guidance Raising Revenue Guidance; Narrowing EPS Outlook Metric Fiscal Fourth-Quarter 2017 Fiscal Year 2017 Revenue $192 to $194 million $763 to $765 million GAAP Diluted EPS $0.11 to $0.13 $0.23 to $0.25 Adjusted EPS $0.26 to $0.28 $1.01 to $1.03 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/
Strongest 3Q Sequential Growth in Five Years Sales Force Productivity and New Strategies Leading to Strong Momentum Sequential Growth in Hereditary Cancer Quarterly Volumes
Volume With Out-of-Network Plans Grew Sequentially Physicians and Patients Continue To Demand Myriad’s Superior Quality As out-of-network provider: Physicians continue to demand highest quality test Out-of-network volume grew sequentially in Q3 Billed at list price with no discount 95%
High Discordance in Public Databases Myriad’s Database Provides Highest Quality Answers n=603 n=155 26% Conflicting interpretation between laboratories Source: PROMPT Study presented at ASCO 2016 Annual Meeting PROMPT Study n=4,250 Conflicting interpretation between laboratories Source: The Oncologist April 2017 Gradishar Study n=1,135 27%
Substantial Diversification in Testing Volumes > Two Thirds of Volume Attributed to Non-Hereditary Cancer Tests 35% CAGR ≈180,000 tests 99% Hereditary Cancer >600,000 tests ≈ 33% Hereditary Cancer
Reimbursement Will Drive Significant Growth $650M Annual New Product Revenue When Fully Reimbursed Current Revenue Run Rate at Full Reimbursement $50M $90M $490M $20M $650M Combined
Landmark GeneSight Study Fully Enrolled Top Line Data Expected by End of Calendar Year 2017 Mean Improvement in HAM-D17 FDA Approved Medications* Top Line Data in 2017 *Sources: FDA summary bases of approvals Hall-Flavin DK, et al. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenetics and Genomics. 2013;23(10):535-548 Winner JG, et al. A prospective, randomized double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discovery Med. 2013;16(89): 219-227 Hall-Flavin DK, et al. Using a pharmacogenomic algorithm to guide the treatment of depression. Transl Psychiatry. 2012;2:e 172 GeneSight showed greater than twice the improvement in HAM-D17 scores relative to trials with blockbuster depression medications
Strong New Health Economic Data For GeneSight Mounting Evidence Supporting Substantial Cost Savings Year-One Cost Savings With GeneSight Data in CY17 Sources: Winner JG, et al. Combinatorial pharmacogenomic guidance for psychiatric medications reduces overall pharmacy costs in a 1 year prospective evaluation. Curr Med Res Opin. 2015 Jul 23:1-11. [PMID: 26086890] Winner JG, Allen JD, et al. Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl Psychiatry. 2013;3:e300. doi:10. 1038/tp.2013.2 Data presented at the Neuroscience Education Institute Annual Conference 2016 Clinical Therapeutics February 2017
Preventive Care Pilot Highly Successful Significant Opportunity to Leverage Large Preventive Care Sales Team Treating Physician for Patients With Major Depressive Disorder Most MDD patients are seen by primary care consisting of general practice, internal medicine and OB/GYNs. Top 16,000 primary care physicians and OB/GYN channel order almost half of the prescriptions for MDD. Sales reps in pilot study generated average volumes at an annual run rate of 300 tests per year.
Clinical Guidelines Increasingly Recognize Vectra DA ACR Diagnostic Guideline Review Will Occur This Fall December 2016 United Rheumatology Clinical Practice Guidelines February 2017 Creaky Joints Guidelines (Major Patient Advocacy Group) Review in Fall 2017 American College of Rheumatology Diagnostic Guidelines
New LCD Would Expand Coverage For Prolaris 50% of Prostate Cancer Patients (>100,000/yr) Would be Covered 200,000 localized prostate cancer patients Prolaris Insurance Coverage Medicare Low Risk Medicare (Favorable Intermediate) Medicare Non - Covered Commercial Non - Covered Commercial Covered
New Study Shows Ability to Predict Metastases Adding Metastases to Clinical Report Provides Added Value to Physicians
EndoPredict Has Both Sets of Predictive Genes Superior Ability to Predict Late-Stage Recurrence Proliferation Genes ER-Signaling Genes Prediction of late-stage recurrence 0-5 years Prediction of late-stage recurrence 5-10 years p<0.001 p<0.001 p=0.204 p=0.298
Ramping Payer Coverage for EndoPredict Now Covered by Plans Representing 83 Million Lives in United States Commercial Covered Submitted dossier to Medicare in Q317 Favorable recommendation from BCBS tech assessment committee Evidence Street Coverage decisions from payers representing 83 million lives
New Indication Would Represent 60,000 Patients/Yr 3x the Size of Ovarian Cancer Market Diagnosed with or progress to metastatic disease HER2+ 40,000 HER2- 60,000 155,000 Two-thirds not currently eligible for hereditary cancer testing Don’t progress to metastatic disease 255,000 cases of invasive breast cancer Copyright © 2017 Myriad Genetics, Inc., all rights reserved. www.Myriad.com.
Multiple PARP Clinical Studies to Report in CY17 8 Additional Pivotal Clinical Study Results Expected Indication Number of Studies First Data Expected Total Patients HER2- metastatic breast cancer 3 AZN olaparib data reported - OlympiAD 160,000 Neoadjuvant TNBC 1 Jun. 2017 70,000 Other ovarian 3 AZN olaparib data reported – SOLO2 50,000 Pancreatic 1 Dec. 2017 100,000 Total 380,000
Final myPath Melanoma Studies Published Dossier Submitted to Medicare and Private Payers myPath Melanoma Diagnostic Accuracy myPath Melanoma Diagnostic Accuracy myPath Melanoma Clinical Utility n=437 patients n=736 patients n=218 patients n=182 patients Sources: Data presented at ASDP: Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a Gene Expression Signature and Correlation to Clinical Outcome. Clarke L et al. Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma J Cutan Pathol 2015; 42:244-252. Cockerell et al. The Influence of a Gene Expression Signature on the Diagnosis and Recommended Treatment of Melanocytic Tumors by Dermatopathologists. Medicine. 2016; 95(40):e4887
International Product Revenue Up 41% Driven by Strong Growth and Expanding Reimbursement for EndoPredict 109% Growth French public health care system funding began in 1H CY16 covering all patients. German national reimbursement (GBA) covering local testing in authorized major centers. Submitted to U.K. NICE and Health Canada; expect decision in 1H CY18.