On November 7, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal first-quarter 2018, provided an update on recent business highlights, maintained its fiscal year 2018 financial guidance, and issued fiscal second-quarter 2018 financial guidance (Press release, Myriad Genetics, NOV 7, 2017, View Source [SID1234521682]).
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"The first quarter exceeded our expectations and represented an excellent start to the fiscal year as a result of strong hereditary cancer and GeneSight test demand," said Mark C. Capone, president and CEO, Myriad Genetics. "Perhaps more importantly we had a number of significant reimbursement catalysts that strengthen our ability to deliver on our long-term financial goals."
Financial Highlights
The following table summarizes the financial results for the fiscal first-quarter 2018:
Revenue
Fiscal First-Quarter
($ in millions) 2018
2017
%
Change
Molecular diagnostic testing revenue
Hereditary cancer testing revenue $ 126.7 $ 139.3 (9 %)
GeneSight testing revenue 28.8 7.2 300 %
Vectra DA testing revenue 16.0 11.6 38 %
Prolaris testing revenue 2.9 2.9 0 %
EndoPredict testing revenue 1.9 1.7 12 %
Other testing revenue 2.5 2.4 4 %
Total molecular diagnostic testing revenue 178.8 165.1 8 %
Pharmaceutical and clinical service revenue 11.4 12.4 (8 %)
Total Revenue $ 190.2 $ 177.5 7 %
Income Statement
Fiscal First-Quarter
($ in millions) 2018
2017
%
Change
Total Revenue $ 190.2 $ 177.5 7 %
Gross Profit 147.2 137.5 7 %
Gross Margin 77.4 % 77.5 %
Operating Expenses 59.8 131.8 (55 %)
Operating Income 87.4 5.7 1433 %
Operating Margin 46.0 % 3.2 %
Adjusted Operating Income 24.7 21.6 14 %
Adjusted Operating Margin 13.0 % 12.2 %
Net Income 81.1 (1.2 ) NM
Diluted EPS 1.15 (0.02 ) NM
Adjusted EPS $ 0.26 $ 0.23 13 %
Business Highlights
• Hereditary Cancer
Exceeded three percent hereditary cancer volume target in the first quarter, and achieved the third straight quarter of volume growth with pricing in-line with expectations.
Launched riskScore, a new clinically validated personalized medicine tool to enhance the myRisk Hereditary Cancer test. riskScore quantifies a woman’s risk of developing breast cancer by combining genetic markers throughout the genome with her family and clinical history and represents a major new epoch in hereditary cancer testing.
Presented data at the National Society of Genetic Counselors demonstrating that in a cohort of 17,205 women, the riskScore single nucleotide polymorphism (SNP) panel was highly predictive of breast cancer risk with a p- value of less than 10-50.
The National Comprehensive Cancer Network (NCCN) updated their professional guidelines to include a recommendation that all metastatic prostate cancer patients receive hereditary cancer testing. There are approximately 26,000 men in the United States every year who develop metastatic prostate cancer.
• GeneSight
Achieved statistically significant improvement in the gold-standard outcomes of response and remission in 1,200 patient prospective randomized controlled trial.
Presented data from the IMPACT study at the World Congress of Psychiatric Genetics demonstrating that GeneSight statistically significantly improved anxiety symptom severity in 210 patients with generalized anxiety disorder. Anxiety symptoms based on the GAD-7 scale, improved 45 percent in patients receiving congruent therapy versus 26 percent for patients receiving non-congruent therapy. The result was statistically significant with a p-value of 0.03.
Presented MEDCO health economic data showing patients with generalized anxiety disorder who used GeneSight saved on average $6,747 in prescription costs with congruent versus non-congruent therapy selection.
• Vectra DA
Presented data at the American College of Rheumatology (ACR) meeting demonstrating that Vectra DA was four times better at predicting radiographic progression compared to DAS28 and other conventional measures of disease activity.
Presented new clinical utility data from 60,596 patients demonstrating that physicians use Vectra DA scores to change treatment decisions appropriately. The study found that in patients who were naive to biologics, rheumatologists were 118 percent more likely to recommend a biologic for patients with a high Vectra DA score when compared to patients with a low Vectra DA score. For patients already on a biologic, rheumatologists were 158 percent more likely to change therapy on patients with high Vectra DA scores compared to those with low Vectra DA scores.
Signed coverage with evidence development agreement with CareFirst BlueCross BlueShield, the 18th largest commercial payer in the United States.
• EndoPredict
Presented new data at the World Congress on Controversies in Breast Cancer. In a study of 387 women determined to be at intermediate risk by the Nottingham Prognostic Index, EndoPredict markedly outperformed the first generation test with two times the prognostic power. Additionally, in this patient cohort EndoPredict was the only test that was statistically significant for predicting late stage recurrence (5-10 years).
• Companion Diagnostics
Submitted a supplemental PMA for BRACAnalysis CDx in conjunction with AstraZeneca’s Lynparza submission for HER2- metastatic breast cancer with approval expected in the fiscal third quarter.
UnitedHealthcare recently updated its hereditary breast and ovarian cancer coverage policy to include coverage for all metastatic breast cancer patients based upon the need to evaluate these patients for PARP inhibitor therapy.
• International
Signed the company’s first payer demonstration study with GeneSight in Canada with Sun Life Financial, the largest private health insurer in Canada. The study will evaluate the ability of GeneSight to improve both clinical and health economic outcomes in patients with anxiety and depression.
Submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for use in HER2- metastatic breast cancer patients.
Fiscal Year 2018 and Fiscal Second-Quarter 2018 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2018 and fiscal second-quarter 2018 financial guidance:
Revenue GAAP Diluted
Earnings Per
Share Adjusted
Earnings Per
Share
Fiscal Year 2018 $750-$770
million $1.41-$1.46 $1.00-$1.05
Fiscal Second-Quarter 2018 $187-$189
million $0.08-$0.10 $0.22-$0.24
These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today to discuss the fiscal first-quarter financial results, fiscal year 2018 financial guidance, and fiscal second-quarter 2018 financial guidance.
Conference Call and Webcast
A conference call will be held today, Tuesday, November 7, 2017, at 4:30 p.m. EST to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-701-6414. International callers may dial 1-303-223-4376. All callers will be asked to reference reservation number 21859999. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.