UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
For the quarterly period ended March 31, 2014
OR
For the transition period from to
Commission file number: 0-26642
MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
Registrants telephone number, including area code: (801) 584-3600
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of accelerated filer, large accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. Check one:
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of May 2, 2014 the registrant had 74,823,792 shares of $0.01 par value common stock outstanding.
INDEX TO FORM 10-Q
Financial Statements
Condensed Consolidated Balance Sheets (Unaudited) as of March 31, 2014 and June 30, 2013
Condensed Consolidated Statements of Income and Comprehensive Income (Unaudited) for the three and nine months ended March 31, 2014 and 2013
Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended March 31, 2014 and 2013
Notes to Condensed Consolidated Financial Statements (Unaudited)
Managements Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Controls and Procedures
Legal Proceedings
Risk Factors
Unregistered Sales of Equity Securities and Use of Proceeds
Defaults Upon Senior Securities
Mine Safety Disclosures
Other Information
Exhibits
2
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
Current assets:
Cash and cash equivalents
Marketable investment securities
Prepaid expenses
Inventory
Trade accounts receivable, less allowance for doubtful accounts of $9,750 at March 31, 2014 and $7,500 at June 30, 2013
Deferred taxes
Prepaid taxes
Other receivables
Total current assets
Equipment and leasehold improvements:
Equipment
Leasehold improvements
Less accumulated depreciation
Net equipment and leasehold improvements
Long-term marketable investment securities
Long-term deferred taxes
Note receivable
Other assets
Intangibles, net
Goodwill
Total assets
Current liabilities:
Accounts payable
Accrued liabilities
Deferred revenue
Total current liabilities
Unrecognized tax benefits
Deferred tax liabilities
Total liabilities
Stockholders equity:
Preferred stock, $0.01 par value, authorized 5,000 shares, issued and outstanding no shares
Common stock, $0.01 par value, authorized 150,000 shares at March 31, 2014 and June 30, 2013, issued and outstanding 74,513 at March 31, 2014 and 80,577 at June 30, 2013
Additional paid-in capital
Accumulated other comprehensive income (loss)
Retained earnings
Total stockholders equity
See accompanying notes to condensed consolidated financial statements (unaudited).
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND COMPREHENSIVE INCOME (UNAUDITED)
Molecular diagnostic testing
Companion diagnostic services
Total revenue
Costs and expenses:
Cost of molecular diagnostic testing
Cost of companion diagnostic services
Research and development expense
Selling, general, and administrative expense
Total costs and expenses
Operating income
Other income (expense):
Interest income
Other
Total other income
Income before income taxes
Income tax provision
Net income
Earnings per share:
Basic
Diluted
Weighted average shares outstanding
Comprehensive income:
Unrealized gain on available-for-sale securities, net of tax
Change in foreign currency translation adjustment, net of tax
Comprehensive income
4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
Cash flows from operating activities:
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization
Loss on disposition of assets
Share-based compensation expense
Bad debt expense
Impairment of intangible asset
Accreted interest on note receivable
Excess tax benefit from share-based compensation
Deferred income taxes
Changes in operating assets and liabilities:
Trade accounts receivable
Prepaid Taxes
Net cash provided by operating activities
Cash flows from investing activities:
Capital expenditures for equipment and leasehold improvements
Acquisition of Crescendo Biosciences, Inc. (see Note 9), net of cash acquired
Purchases of marketable investment securities
Proceeds from maturities and sales of marketable investment securities
Net cash provided by investing activities
Cash flows from financing activities:
Net proceeds from common stock issued under share-based compensation plans
Repurchase and retirement of common stock
Net cash used in financing activities
Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
5
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The accompanying condensed consolidated financial statements have been prepared by Myriad Genetics, Inc. (the Company) in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and pursuant to the applicable rules and regulations of the Securities and Exchange Commission (SEC). The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying financial statements contain all adjustments (consisting of normal and recurring accruals) necessary to present fairly all financial statements in accordance with GAAP. The condensed consolidated financial statements herein should be read in conjunction with the Companys audited consolidated financial statements and notes thereto for the fiscal year ended June 30, 2013, included in the Companys Annual Report on Form 10-K for the fiscal year ended June 30, 2013. Operating results for the three and nine months ended March 31, 2014 may not necessarily be indicative of results to be expected for any other interim period or for the full year.
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Certain reclassifications have been made to prior period amounts to conform to the current period presentation.
The Company has classified its marketable investment securities as available-for-sale securities. These securities are carried at estimated fair value with unrealized holding gains and losses, net of the related tax effect, included in accumulated other comprehensive loss in stockholders equity until realized. Gains and losses on investment security transactions are reported on the specific-identification method. Dividend and interest income are recognized when earned. The amortized cost, gross unrealized holding gains, gross unrealized holding losses, and fair value for available-for-sale securities by major security type and class of security at March 31, 2014 and June 30, 2013 were as follows:
At March 31, 2014:
Cash and cash equivalents:
Cash
Cash equivalents
Total cash and cash equivalents
Available-for-sale securities:
Corporate bonds and notes
Municipal bonds
Federal agency issues
Total available-for-sale securities
Total cash, cash equivalents and available-for-sale securities
6
At June 30, 2013:
Cash, cash equivalents, and maturities of debt securities classified as available-for-sale securities are as follows at March 31, 2014:
Available-for-sale:
Due within one year
Due after one year through five years
Due after five years
The Company maintains a share-based compensation plan, the 2010 Employee, Director and Consultant Equity Incentive Plan, as amended (the 2010 Plan), that has been approved by the Companys shareholders. The 2010 Plan allows the Company, under the direction of the Compensation Committee of the Board of Directors, to make grants of stock options, restricted and unrestricted stock awards and other stock-based awards to employees, consultants and directors. On December 5, 2013, the shareholders approved an amendment to the 2010 Plan to set the number of shares available for grant to 3,500,000. At March 31, 2014, 3,757,761 shares were available for issuance, which includes 257,761 shares carried over from the Companys 2003 Employee, Director and Consultant Option Plan (the 2003 Plan) and the 2010 Plan that were cancelled or expired without the issuance of shares of common stock by the Company. In addition, as of March 31, 2014, the Company may grant up to 5,509,201 additional shares under the 2010 Plan if options previously granted under 2003 Plan are cancelled or expire without the issuance of shares of common stock by the Company.
The number of shares, terms, and vesting period of awards under the 2010 Plan are determined by the Compensation Committee of the Board of Directors for each equity award. Options under the plan granted prior to December 5, 2012 generally vest ratably over four years and expire ten years from the grant date. Options granted after December 5, 2012 generally vest ratably over four years and expire eight years from the grant date. The exercise price of options granted is equivalent to the fair market value of the stock on the grant date.
The Company also has an Employee Stock Purchase Plan that was approved by shareholders in 2012 (the 2012 Purchase Plan), under which 2,000,000 shares of common stock have been authorized. Shares are issued under the 2012 Purchase Plan twice yearly at the end of each offering period. As of March 31, 2014, approximately 144,000 shares of common stock have been issued under the 2012 Purchase Plan and approximately 1,856,000 were available for issuance.
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A summary of the stock option activity under the Companys plans for the nine months ended March 31, 2014 is as follows:
Options outstanding at June 30, 2013
Options granted
Less:
Options exercised
Options canceled or expired
Options outstanding at March 31, 2014
As of March 31, 2014, options to purchase 7,823,794 shares were vested and exercisable at a weighted average price of $21.86. As of March 31, 2014, there was $46.5 million of total unrecognized share-based compensation expense related to share-based awards granted under the Companys plans that will be recognized over a weighted-average period of 2.49 years.
Share-based compensation expense recognized and included in the condensed consolidated statements of income was allocated as follows:
Total share-based compensation expense
Total stock-based compensation for the three and nine months ended March 31, 2014 included $0.2 million, $2.0 million and $4.7 million in cost of molecular diagnostic testing, research and development and selling, general and administrative expenses, respectively, related to the acceleration of unvested stock options in connection with the acquisition of Crescendo which closed during February 2014 (see Note 9).
Share Repurchase Program
In November 2013, the Companys Board of Directors authorized a share repurchase program of $300 million of the Companys outstanding common stock. The Company plans to repurchase its common stock from time to time or on an accelerated basis through open market transactions or privately negotiated transactions as determined by the Companys management. The amount and timing of stock repurchases under the program will depend on business and market conditions, stock price, trading restrictions, acquisition activity and other factors. As of March 31, 2014, approximately $231.4 million remained available for repurchases under the current program. The Company uses the par value method of accounting for its stock repurchases. As a result of the stock repurchases, the Company reduced common stock and additional paid-in capital and recorded charges to retained earnings. The shares retired, aggregate common stock and additional paid-in capital reductions, and related charges to retained earnings for the repurchases for the three and nine months ended March 31, 2014 and 2013 were as follows:
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Shares purchased and retired
Common stock and additional paid-in-capital reductions
Charges to retained earnings
Basic earnings per share is computed based on the weighted-average number of shares of the Companys common stock outstanding. Diluted earnings per share is computed based on the weighted-average number of shares of the Companys common stock, including the dilutive effect of common stock equivalents outstanding.
The following is a reconciliation of the denominators of the basic and diluted earnings per share computations:
Denominator:
Weighted-average shares outstanding used to compute basic earnings per share
Effect of dilutive stock options
Weighted-average shares outstanding and dilutive securities used to compute dilutive earnings per share
Certain outstanding stock options were excluded from the computation of diluted earnings per share for the three and nine months ended March 31, 2014 and 2013 because the effect would have been anti-dilutive. These potential dilutive common shares, which may be dilutive to future diluted earnings per share, are as follows:
Anti-dilutive options excluded from EPS computation
The Companys business units have been aggregated into three reportable segments: (i) research, (ii) molecular diagnostics and (iii) companion diagnostics. The research segment is focused on the discovery of genes, biomarkers and proteins related to major common diseases and includes corporate services such as finance, human resources, legal, and information technology. The molecular diagnostics segment provides testing that is designed to assess an individuals risk for developing disease later in life, identify a patients likelihood of responding to drug therapy and guide a patients dosing to ensure optimal treatment, or assess a patients risk of disease progression and disease recurrence. The business of Crescendo acquired in February 2014 is included as part of the molecular diagnostic segment. The companion diagnostics segment provides testing products and services to the pharmaceutical, biotechnology and medical research industries. The Company evaluates segment performance based on results from operations before interest income and expense and other income and expense.
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Segment revenue and operating income (loss) were as follows during the periods presented:
Three months ended March 31, 2014:
Revenue
Segment operating income (loss)
Three months ended March 31, 2013:
Nine months ended March 31, 2014:
Nine months ended March 31, 2013:
Total operating income for reportable segments
The fair value of the Companys financial instruments reflects the amounts that the Company estimates it will receive in connection with the sale of an asset or pay in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy prioritizes the use of inputs used in valuation techniques into the following three levels:
The substantial majority of the Companys financial instruments are valued using quoted prices in active markets or based on other observable inputs. For Level 2 securities, the Company uses a third party pricing service which provides documentation on an ongoing basis that includes, among other things, pricing information with respect to reference data, methodology, inputs summarized by asset class, pricing application and corroborative information. The Company reviews, tests and validates this information. The following table sets forth the fair value of the financial assets that the Company re-measured on a regular basis:
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at March 31, 2014:
Money market funds (a)
Total
at June 30, 2013:
In order to determine the Companys quarterly provision for income taxes, the Company used an estimated annual effective tax rate that is based on expected annual income and statutory tax rates in the various jurisdictions in which the Company operates. Certain significant or unusual items are separately recognized in the quarter during which they occur and can be a source of variability in the effective tax rates from quarter to quarter.
Income tax expense for the three months ended March 31, 2014 was $20.6 million, or approximately 36% of pre-tax income, compared to $21.3 million, for the three months ended March 31, 2013, or approximately 36% of pre-tax income. Income tax expense for the nine months ended March 31, 2014 was $82.7 million, or approximately 37% of pre-tax income, compared to $63.0 million for the nine months ended March 31, 2013, or approximately 38% of pre-tax income. Income tax expense for the three and nine months ended March 31, 2014 is based on the Companys estimated annual effective tax rate for the full fiscal year ending June 30, 2014, adjusted by discrete items recognized during the period. For the nine months ended March 31, 2014, the Companys recognized effective tax rate differs from the U.S. federal statutory rate of 35% primarily due to the effect of state income taxes, a deduction for the write-off of stock in a wholly-owned subsidiary divested during the period, certain losses incurred by our international operations for which no tax benefit is recognized, as well as timing differences related to the recognition of the tax effect of equity compensation expense from incentive stock options and the deduction realized if those options are disqualified upon exercise and sale.
The Company files U.S., U.K., France and state income tax returns in jurisdictions with various statutes of limitations. The Companys New York income tax returns for the years ended June 30, 2010, 2011 and 2012 are currently under examination by the New York State Department of Taxation and Finance. The Companys Washington income tax returns for the period January 1, 2010 to March 31, 2014 are currently under examination by the Washington State Department of Revenue. Annual and interim tax provisions include amounts considered necessary to pay assessments that may result from examination of prior year tax returns; however, the amount ultimately paid upon resolution of issues may differ materially from the amount accrued. The Companys U.S. federal tax return, U.K. and France income tax returns and all other state tax returns are not currently under examination.
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On February 28, 2014, the Company completed the acquisition of privately-held Crescendo Bioscience, Inc. (Crescendo), pursuant to an Amended and Restated Agreement and Plan of Merger, dated February 2, 2014 (the Merger Agreement). Pursuant to the terms of the Merger Agreement, Myriad acquired Crescendo for total consideration of $259.0 million, as detailed below, by means of a reverse triangular merger in which Crescendo survived the merger as the surviving corporation and a wholly-owned subsidiary of Myriad. The surviving corporation will operate under the name Crescendo Bioscience, Inc.
The following table reconciles consideration transferred to the total cash paid to acquire Crescendo:
Total consideration transferred
Share-based compensation to Crescendo employees
Change of control payments to Crescendo employees
Offset: Non-cash fair value purchase option
Total cash paid
The total consideration of $259.0 million, consisted of (i) $225.1 million in cash, (ii) $25.9 million in elimination of intercompany balances related to accrued interest and the term loan the Company issued to Crescendo on September 8, 2011, and (iii) $8.0 million related to the fair value of the purchase option granted to the Company on September 8, 2011 by Crescendo through a definitive merger agreement (Option Agreement) entered into in association with the term note. Of the cash consideration, $20.0 million of was deposited into an escrow account to fund (i) any post-closing adjustments payable to Myriad based upon differences between the estimated working capital and the actual working capital of Crescendo at closing, and (ii) any indemnification claims made by Myriad against Crescendo, for a period of time, based upon the completion of an audit of Crescendos financial statements, of no fewer than twelve nor more than fifteen months following closing.
Of the total cash paid, $6.9 million was accounted for as share-based compensation expense resulting from the accelerated vesting of employee options immediately prior to the acquisition and $5.7 million was accounted for as change of control bonuses paid to Crescendo employees and directors. The Company recognized the share-based compensation expense and change of control bonuses in the three and nine month March 31, 2014 post-acquisition Condensed Consolidated Statements of Income for the three and nine month periods ended March 31, 2014.
Total consideration transferred was allocated to tangible and identifiable intangible assets acquired and liabilities assumed based on their preliminary fair values at the acquisition date as set forth below. The Company believes that the acquisition of Crescendo facilitates the Companys entry into the high growth autoimmune market, diversifies its product revenue and enhances its strength in protein-based diagnostics. These factors contributed to consideration transferred in excess of the fair value of Crescendos net tangible and intangible assets acquired, resulting in the Company recording goodwill in connection with the transaction. Management estimated the fair values of tangible and intangible asset and liabilities in accordance with the applicable accounting guidance for business combinations and utilized the services of third-party valuation consultants. The preliminary allocation of the consideration transferred is subject to potential adjustments primarily due to tax-related matters that could have a material impact on the consolidated financial statements. The Company expects the allocation of the consideration transferred to be final within the measurement period (up to one year from the acquisition date).
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The Companys preliminary allocation of consideration transferred for Crescendo is as follows (in thousands):
Other assets acquired
Intangible assets
Total assets acquired
Deferred tax liability
Other liabilities assumed
Total net assets acquired
Identifiable Intangible Assets
The Company acquired intangible assets that consisted of developed technology which had an estimated fair value of $165.4 million and a laboratory database with an estimated fair value of $31.2 million. The fair values of the assets were determined using a probability-weighted income approach that discounts expected future cash flows to present value. The estimated net cash flows were discounted using a discount rate of 19% which is based on the estimated internal rate of return for the acquisition and represent the rate that market participants might use to value the intangible assets. The projected cash flows were based on key assumptions such as: estimates of revenues and operating profits; the time and resources need to recreate databases and product and commercial development and approval; the life of the commercialized product; and associated risks related to viability and product alternatives. The Company will amortize the intangible assets on a straight-line basis over their estimated useful lives of 18 years. This amortization is not deductible for income tax purposes.
The $109.9 million of goodwill represents the excess of consideration transferred over the fair value of assets acquired and liabilities assumed and is attributable to the benefits expected from combining the Companys research and commercial operations with Crescendos. This goodwill is not deductible for income tax purposes.
Share-Based Compensation
The share-based compensation expense recognized for the accelerated vesting of employee options immediately prior to the acquisition was reported in the Companys Condensed Consolidated Statements of Income as follows:
Total share-based compensation
Change of Control
The change of control expense recognized for bonuses paid to Crescendo employees and directors for completion of the acquisition with Myriad was reported in the Companys Condensed Consolidated Statements of Income as follow:
Total change of control bonuses
Both the share-based compensation and change of control expenses are one-time items and will not impact future reporting periods.
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The Company also recorded interest income related to accretion of the note receivable that was settled at the acquisition date, for the three and nine months ended March 31, 2014 of $2.3 million and $4.5 million, respectively, in the Condensed Consolidated Statements of Income. From the date of acquisition through March 31, 2014, the Company recorded Crescendo revenue of approximately $3.1 million and a net loss from Crescendo of approximately $16.3 million that included non-recurring acquisition related charges of $12.6 million.
Pro Forma Information
The unaudited pro-forma results presented below include the effects of the Crescendo acquisition as if it had been consummated as of July 1, 2012, with adjustments to give effect to pro forma events that are directly attributable to the acquisition which includes adjustments related to the amortization of acquired intangible assets, interest income and expense, stock-based compensation expense, and depreciation. The unaudited pro forma results do not reflect any operating efficiency or potential cost savings which may result from the consolidation of Crescendo. Accordingly, these unaudited pro forma results are presented for informational purposes only and are not necessarily indicative of what the actual results of operation of the combined company would have been if the acquisition had occurred at the beginning of the period presented nor are they indicative of future results of operations and are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisition been consummated as of July 1, 2012.
Income from operations
Net income per share, basic
Net income per share, diluted
Changes in the carrying amount of goodwill consisted of the following:
Balance at the beginning of the period
Current period acquisitions
Balance at the end of the period
For a discussion of the changes in goodwill, see Note 9.
Intangible Assets
Intangible assets primarily consist of amortizable assets of purchased licenses and technologies, customer relationships, and trade names as well as non-amortizable intangible assets of in-process technologies and research and development. The following summarizes the amounts reported as intangible assets:
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March 31, 2014:
Purchased licenses and technologies
Customer relationships
Trademarks
Total amortizable intangible assets
In-process research and development
Total non-amortizable intangible assets
Total intangible assets
June 30, 2013:
The Company recorded amortization expense during the respective periods for these intangible assets as follows:
Amortization on intangible assets
For a discussion of changes in intangible assets and amortization, see Note 9.
As of March 31, 2014, the Company had a $5.0 million investment in RainDance Technologies, Inc. which has been recorded under the cost method as an Other Asset on the Companys condensed consolidated balance sheet. There were no events or circumstances that indicated that impairment exists; therefore, the Company recorded no impairment in the investment for the three or nine months ended March 31, 2014.
The Company is subject to various claims and legal proceedings covering matters that arise in the ordinary course of its business activities. As of March 31, 2014, the management of the Company believes any liability that may ultimately result from the resolution of these matters will not have a material adverse effect on the Companys consolidated financial position, operating results, or cash flows.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
We are a leading molecular diagnostic company dedicated to making a difference in patients lives through the discovery and commercialization of novel, transformative tests across major diseases. We believe in improving healthcare for patients by providing physicians with important information to answer critical questions and solve unmet medical needs. Through our proprietary technologies, we believe we are positioned to identify important disease genes, the proteins they produce, and the biological pathways in which they are involved to better understand the underlying molecular basis for the cause of human disease. We believe that identifying these biomarkers (the genes, their expression levels, and the proteins they produce) will enable us to develop novel molecular diagnostic tests.
Our goal is to provide physicians with critical information that may guide the healthcare management of their patients to prevent disease, diagnose the disease at an earlier stage, determine the most appropriate therapy, and assess the aggressiveness of their disease. Our proprietary technologies, including DNA, RNA and protein analysis, help us to understand the genetic basis of human disease and the role that genes and their related proteins may play in the onset and progression of disease. We use this information to guide the development of new molecular diagnostic tests that are designed to assess an individuals risk for developing disease later in life (predictive medicine), identify a patients likelihood of responding to drug therapy and guide a patients dosing to ensure optimal treatment (personalized medicine), assess a patients risk of disease progression and disease recurrence (prognostic medicine) or accurately diagnose disease (diagnostic medicine).
Our business strategy for future growth is focused on three key initiatives. First, we are working to grow and expand our existing products and markets. Second, we are developing our business internationally and have recently established operations in Europe and Canada. Finally, we are launching and intend to continue to launch new potentially transformative products across a diverse set of disease indications, complementing our current businesses in oncology, womens health, urology, dermatology and rheumatology.
On February 28, 2014, we completed the acquisition of privately-held Crescendo Bioscience, Inc. (Crescendo), pursuant to an Amended and Restated Agreement and Plan of Merger, dated February 2, 2014, for $270 million in cash which was reduced by the repayment of a loan made to Crescendo and other customary adjustments in accordance with acquisition agreement. We believe that the acquisition of Crescendo facilitates our entry into the high growth autoimmune market, diversifies our product revenue and enhances our strength in protein-based diagnostics. The business of Crescendo, including its Vectra®DA blood test for rheumatoid arthritis disease activity, will be operated as one of our wholly owned subsidiaries.
Products and Services
We offer fourteen commercial molecular diagnostic tests, consisting of seven predictive medicine tests, three personalized medicine tests, and three prognostic medicine tests and one diagnostic medical test. We market these tests in the United States through our own sales force of approximately 430 people. We have also established commercial laboratory operations in Munich, Germany and international headquarters in Zurich, Switzerland. We currently market our MyRisk®, BRACAnalysis®, COLARIS®, COLARIS AP®, and Prolaris® and EndoPredict products through our own sales force in Europe and Canada and have entered into distributor agreements with organizations in select Latin American, Middle Eastern, Asian and African countries.
Our fourteen commercial molecular diagnostic tests include:
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On September 3, 2013, we launched Myriad myRiskTM Hereditary Cancer to physician thought leaders as part of a staged product rollout. We began expanding physician access to Myriad myRisk Hereditary Cancer in February 2014. On October 29, 2013, we launched Myriad myPlan Lung Cancer to leading oncologists throughout the United States and on November 12, 2013, we launched Myriad myPath Melanoma to leading dermatopathologists across the country. We intend to expand access to Myriad myPlan Lung Cancer and Myriad myPath Melanoma throughout the remainder of our fiscal year ending June 30, 2014.
In January 2014, we acquired international (ex United States) rights to EndoPredict from Sividon in Germany and have been marketing it to leading pathologists. In February 2014, we acquired Vectra DA through the acquisition of Crescendo. Through Crescendo, our wholly owned subsidiary, we provide molecular diagnostics focused on rheumatology. Crescendo is developing quantitative, objective, biology-based tests to provide rheumatologists with deeper clinical insights to help enable more effective management of patients with autoimmune and inflammatory diseases.
Through our wholly owned subsidiary, Myriad RBM, Inc., we provide biomarker discovery and companion diagnostic services to the pharmaceutical, biotechnology, and medical research industries utilizing our multiplexed immunoassay technology. Our technology enables us to efficiently screen large sets of clinical samples from both diseased and non-diseased populations against our extensive menu of protein biomarkers. By analyzing the data generated from these tests, we attempt to discover biomarker patterns that may be used to identify patients who would likely respond to a particular therapy. In addition to the companion diagnostic research revenue received from analyzing these samples, we also use this information to create and validate new biomarkers that can aid us in the development of our own novel molecular diagnostic tests that could aid a physician in making diagnostic and treatment decisions.
Use of Resources
During the three and nine months ended March 31, 2014, we devoted our resources to supporting and growing our molecular diagnostic and companion diagnostic businesses, as well as to the research and development of future molecular and companion diagnostic candidates. We have three reportable operating segmentsresearch, molecular diagnostics and companion diagnostics. See Note 6 Segment and Related Information in the notes to our condensed consolidated financial statements (unaudited) for information regarding these operating segments. In addition, we used net cash of $223.5 million to acquire Crescendo on February 28, 2014. See Note 9 in the notes to our condensed consolidated financial statements (unaudited).
For the three and nine months ended March 31, 2014, we had net income of $36.8 million and $142.6 million and diluted earnings per share of $0.48 and $1.82, compared to net income of $37.9 million and $103.1 million and diluted earnings per share of $0.46 and $1.23 per share in the same period in the prior year. Net income and diluted earnings per share results for the three and nine months ended March 31, 2014 included income tax expense of $20.6 million and $82.7 million compared to $21.3 million and $63.0 million for the same period in the prior year.
In November 2013, we announced that our board of directors had authorized us to repurchase an additional $300 million of our outstanding common stock increasing our total share repurchase authorization to $1 billion. During the three and nine months ended March 31, 2014, we repurchased $41.9 million and $222.0 million, respectively, of our outstanding common stock. In connection with our stock repurchase program our board of directors authorized us to repurchase shares from time to time or on an accelerated basis through open market transactions or privately negotiated transactions as determined by our management. The amount and timing of stock repurchases under the program will depend on business and market conditions, stock price, trading restrictions, acquisition activity and other factors. See also Part II, Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Issuer Purchases of Equity Securities.
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Critical Accounting Policies
Critical accounting policies are those policies which are both important to the presentation of a companys financial condition and results and require managements most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. No significant changes to our accounting policies took place during the period. For a further discussion of our critical accounting policies, see our Annual Report on Form 10-K for the fiscal year ended June 30, 2013.
Results of Operations for the Three Months Ended March 31, 2014 and 2013
Revenue is comprised of sales of our molecular diagnostic tests and our companion diagnostic research services. Total revenue for the three months ended March 31, 2014 was $182.9 million, compared to $156.5 million for the same three months in 2013. This 17% increase in revenue is primarily due to increased molecular diagnostic testing volume for our Myriad myRisk Hereditary Cancer test, which we launched during 2013 as well as sales from VectraDA, our new test from the Crescendo subsidiary, as disclosed in the table below. Revenues during the three month period were negatively impacted by approximately $6 million due to a January 1, 2014 Medicare pricing adjustment that was subsequently reversed in part on April 1, 2014. We believe that our increased sales, marketing, and education efforts resulted in wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes. The 17% decrease in companion diagnostic service revenue was due to the timing of research projects with our pharmaceutical partners and will fluctuate. There can be no assurance that our revenue will continue to increase or remain at current levels.
Total revenue of our molecular diagnostic tests and companion diagnostic services and revenue by product as a percent of total revenue for the three months ended March 31, 2014 and 2013 were as follows:
Molecular diagnostic testing revenue:
BRACAnalysis
BART
COLARIS & COLARIS AP
Myriad myRisk
VectraDA
Total molecular diagnostic testing revenue
Companion diagnostic service revenue
Our molecular diagnostic sales force is focused on five major markets, oncology, womens health, urology, dermatology and rheumatology. Oncology and womens health revenue was 52% and 45% of total molecular diagnostic testing revenue, respectively, during the three months ended March 31, 2014. As a result of the newly acquired Crescendo subsidiary in February 2014, we have one month of sales in the rheumatology market during the three months ended March 31, 2014. Sales of molecular diagnostic tests in each major market for the three months ended March 31, 2014 and 2013 were as follows:
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Oncology
Womens health
Rheumatology
Costs and Expenses
Cost of revenue is comprised primarily of salaries and related personnel costs, laboratory supplies, royalty payments, equipment costs and facilities expense. Cost of molecular diagnostic testing revenue for the three months ended March 31, 2014 was $23.6 million, compared to $16.5 million for the same three months in 2013. This increase of 43% in molecular diagnostic testing cost of revenue is primarily due to the 19% increase in testing revenue, the additional costs associated with processing samples from our three newly launched tests at levels which have not yet achieved economies of scale, the acquisition of Crescendo which includes $423 thousand of one-time non-cash expense and the addition of the VectraDA test to our product line which does not have full reimbursement from private payors. Our cost of revenue may continue to fluctuate from quarter to quarter based on the introduction of new molecular diagnostic tests, changes in reimbursement rates, and changes in testing volumes in the molecular diagnostic segments. Our costs of companion diagnostic services include similar items. Cost of companion diagnostic services for the three months ended March 31, 2014 was $3.0 million, compared to $3.9 million for the same three months in 2013. This 24% decrease in companion diagnostic testing cost of revenue is due to the 17% decrease in companion diagnostic revenue as well as increased efficiencies within the laboratory.
Our gross margins for molecular diagnostics were 87% at March 31, 2014, compared to 89% in the same three months of the prior year. Molecular diagnostic margins were impacted by the change in product mix primarily due to the launch or our three new molecular diagnostic tests, the acquisition of Crescendo, the addition of the VectraDA test to the product mix, and the Medicare price reduction on January 2014. There can be no assurance that gross profit margins will remain at current levels.
Our research and development expenses include costs incurred in formulating, improving and creating alternative or modified processes related to and expanding the use of our current molecular diagnostic tests and costs incurred for the discovery, validation and development of our pipeline of molecular and companion diagnostic test candidates. Research and development expenses are comprised primarily of salaries and related personnel costs, laboratory supplies, clinical trial costs, equipment, and facilities costs. Research and development expenses incurred during the three months ended March 31, 2014 were $13.4 million compared to $13.6 million for same three months in 2013. This decrease of 2% was primarily due to the following:
We expect that our research and development expenses as a percentage of revenues will fluctuate over the next several years as we continue to develop our pipeline and expand our offerings of molecular diagnostic tests and companion diagnostic services.
Our sales, general and administrative expenses include costs associated with building our molecular diagnostic and companion diagnostic businesses domestically and internationally. Selling, general and administrative expenses consist primarily of salaries, commissions and related personnel costs for sales, marketing, customer service, billing and
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collection, executive, legal, finance and accounting, information technology, human resources, and allocated facilities expenses. Selling, general and administrative expenses for the three months ended March 31, 2014 were $87.6 million, compared to $64.6 million for the same three months in 2013. The increase in selling, general and administrative expense of 36% was due primarily to the following:
We expect that our selling, general and administrative expenses will continue to fluctuate from quarter to quarter and that such increases may be substantial, depending on the number and scope of any new molecular launches, our efforts in support of our existing molecular diagnostic tests and our continued international expansion efforts.
Other Income (Expense)
Interest income was $2.5 million for the three months ended March 31, 2014 compared to $1.4 million for the three months ended March 31, 2013. Interest income consists primarily of interest income recorded from the note receivable from Crescendo Bioscience, Inc which will not continue in the future.
Income Tax Provision
Income tax expense for the three months ended March 31, 2014 was $20.6 million, for an effective income tax rate of approximately 36%, compared to income tax expense of $21.3 million or a 36% effective income tax rate in the same period in 2013. Our quarterly effective tax rate differs from the U.S. federal statutory rate of 35%, primarily due to a 3% state income tax impact and an approximate 2% impact from exclusion of certain losses incurred from our international operations offset by the benefits realized from the timing differences related to the recognition of the tax effect of equity compensation expense from incentive stock options and the deduction realized when those options are disqualified upon exercise and sale. Certain significant or unusual items are separately recognized during the period in which they occur and can be a source of variability in the effective tax rates from quarter to quarter.
Results of Operations for the Nine Months Ended March 31, 2014 and 2013
Total revenue for the nine months ended March 31, 2014 was $589.5 million, compared to $439.1 million for the same nine months in 2013. This 34% increase in revenue is primarily due to increased molecular diagnostic testing volume for our BRACAnalysis, BART, Colaris and Colaris AP tests and myRisk Hereditary Cancer tests, as well as sales from our VectraDA test, our new test from Crescendo. The increase in companion diagnostic services is due to increased research collaborations with our pharmaceutical partners. We believe that our increased sales, marketing, and education efforts resulted in wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes.
Total revenue of our molecular diagnostic tests and companion diagnostic services and revenue by product as a percent of total revenue for the nine months ended March 31, 2014 and 2013 were as follows:
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Our molecular diagnostic sales force is focused on five major markets, oncology, womens health, urology, dermatology and rheumatology. Oncology and womens health revenue was 53% and 46% of total molecular diagnostic testing revenue, respectively, during the nine months ended March 31, 2014. As a result of the newly acquired Crescendo subsidiary in February 2014, we have one month of sales in the rheumatology market. Sales of molecular diagnostic tests in each major market for the nine months ended March 31, 2014 and 2013 were as follows:
Cost of molecular diagnostic testing revenue for the nine months ended March 31, 2014 was $67.8 million, compared to $46.0 million for the same nine months in 2013. This increase of 48% in molecular diagnostic testing cost of revenue is primarily due to the 36% increase in testing revenue, the additional costs associated with processing samples from our three newly launched tests at levels that have not yet achieved economies of scale, the acquisition of Crescendo and the addition of the VectraDA test. Cost of companion diagnostic services for the nine months ended March 31, 2014 was $10.4 million, compared to $11.6 million for the same three months in 2013. This 10% decrease in companion diagnostic testing cost of revenue is due to increased efficiencies gained in our companion diagnostic laboratory. Gross margins for molecular diagnostics for the nine months ended March 31, 2014 was 88% compared to 89% for the nine months ended March 31, 2014.
Research and development expenses incurred during the nine months ended March 31, 2014 were $47.3 million compared to $39.1 million for same nine months in 2013. This increase of 21% was primarily due to the following:
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Selling, general and administrative expenses for the nine months ended March 31, 2014 were $242.8 million, compared to $180.3 million for the same nine months in 2013. The increase in selling, general and administrative expense of 34% was due primarily to supporting the 34% increase in revenue and include:
Interest income was $5.2 million for the nine months ended March 31, 2014 compared to $4.2 million for the nine months ended March 31, 2013. Interest income consists primarily of interest income recorded from the note receivable from Crescendo Bioscience, Inc.
Income tax expense for the nine months ended March 31, 2014 was $82.7 million, for an effective income tax rate of approximately 37%, compared to income tax expense of $63.0 million or a 38% effective income tax rate in the same period in 2013. Income tax expense for the nine months ended March 31, 2014 is based on our estimated annual effective tax rate for the full fiscal year ending June 30, 2014 adjusted by discrete items recognized during the period. Our annual effective tax rate differs from the U.S. federal statutory rate of 35% primarily due to a 3% blended state income tax rate and 2% impact from certain losses incurred by our international operations offset by certain discrete items that are required to be separately recognized during the quarter in which they occurred, including a deduction for the write-off of stock in a wholly-owned subsidiary recently divested and benefits realized from the timing differences related to the recognition of the tax effect of equity compensation expense from incentive stock options and the deduction realized when those options are disqualified upon exercise and sale. Certain significant or unusual items are separately recognized during the period in which they occur and can be a source of variability in the effective tax rates from period to period.
Liquidity and Capital Resources
Cash, cash equivalents, and marketable investment securities were $277.7 million at March 31, 2014 compared to $531.1 million at June 30, 2013, which is a decrease of $253.4 million. This decrease in cash, cash equivalents and marketable investment securities was attributable to the purchase of $222.0 million of our common stock under our share repurchase programs and the net cash paid for the acquisition of Crescendo of $223.5 million on February 28, 2014 offset by cash collections from molecular and companion diagnostic sales.
Net cash provided by operating activities was $149.3 million during the nine months ended March 21, 2014, compared to $110.9 million during the same nine months in 2013. Our cash from operations was impacted by non-cash charges in the form of share-based compensation and depreciation and amortization, which totaled $20.5 million and $8.3 million, respectively, during the nine months ended March 31, 2014.
Net cash provided by investing activities was $2.2 million during the nine months ended March 31, 2014 compared to $9.0 million during the same nine months in 2013. Investing activities were comprised of $223.5 million investing outflow used for the acquisition of Crescendo and capital expenditures for equipment and facilities of $9.7 million, offset by the net proceeds from the maturity, purchases and sales of marketable investment securities of $235.4 million.
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Financing activities used cash of $169.7 million during the nine months ended March 31, 2014 and $93.9 million in the same nine months in 2013. Cash utilized in financing activities during the nine months ended March 31, 2014 was primarily due to the purchase of $222.0 million of our common stock through our share repurchase programs, partially offset by $47.2 million from cash provided primarily by the exercise of stock options.
During the nine months ended March 31, 2014, cash, cash equivalents and marketable securities, inventory, intangibles, and goodwill were all impacted by the acquisition of Crescendo. Cash, cash equivalents and marketable securities decreased by the $223.5 million due to the cash paid, net of $1.6 million cash acquired, for Crescendo. Inventory, intangibles and goodwill increased by approximately $10.3 million, $195.7 million, and $109.9 million, respectively, due to acquisition of Crescendo on February 28, 2014. See Note 9 in the notes to our condensed consolidated financial statements (unaudited).
We believe that our existing capital resources and net cash expected to be generated from sales of our molecular diagnostic tests and companion diagnostic services will be adequate to fund our current and planned operations for the next several years, although no assurance can be given that changes will not occur that would consume available capital resources more quickly than we currently expect and that we may need or want to raise additional funds. Our future capital requirements, cash flows, and results of operations could be affected by and will depend on many factors that are currently unknown to us, including:
Effects of Inflation
We do not believe that inflation has had a material impact on our business, sales, or operating results during the periods presented.
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Certain Factors That May Affect Future Results of Operations
The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand a companys future prospects and make informed investment decisions. This Quarterly Report on Form 10-Q contains such forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Words such as may, anticipate, estimate, expects, projects, intends, plans, believes and words and terms of similar substance used in connection with any discussion of future operating or financial performance, identify forward-looking statements. All forward-looking statements are managements present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described 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 companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; risks related to increased competition and the development of competing test and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic 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; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; 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 Annual Report on Form 10-K for the fiscal year ended June 30, 2013, 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.
In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report or in any document incorporated by reference might not occur. Stockholders are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Quarterly Report. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements attributable to us or to any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
There have been no material changes in our market risk during the three and nine months ended March 31, 2014 compared to the disclosures in Part II, Item 7A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2013, which is incorporated by reference herein.
Item 4. Controls and Procedures
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In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
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PART IIOther Information
Item 1. Legal Proceedings
Background
Following the U.S. Supreme Court decision in June 2013 in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al., several companies have commenced offering clinical diagnostic and genomic laboratory services, including the testing and analysis of the BRCA1 and BRCA2 genes, that purport to compete with our BRACAnalysis testing and services. We believe that these tests and services infringe various patent claims that we own or have exclusively licensed from the University of Utah Research Foundation, HSC Research and Development Limited Partnership (and affiliate of Hospital For Sick Children), the Trustees of the University of Pennsylvania, and Endorecherche, Inc. (collectively, the Patent Owners). Under our license agreements with the Patent Owners, we are responsible for pursuing these patent infringement litigations, defending any counterclaims and paying related costs. Accordingly, we have commenced several lawsuits alleging that these companies infringe various patent claims owned by Myriad and the Patent Owners and have received several complaints or counterclaims from these companies seeking declaratory judgment that they do not infringe various patent claims owned by Myriad and the Patent Owners and that these patent claims are invalid.
There have been no material developments in the legal proceedings involving Ambry Genetics Corporation, Gene by Gene LTD, Counsyl, Inc., Quest Diagnostics Incorporated and Quest Diagnostics Nichols Institute, GeneDX, Inc., Invitae Corporation, and Laboratory Corporation of America Holdings, previously disclosed in Part II, Item 1 of our Quarterly Reports on Form 10-Q for the fiscal quarters ending December 31, 2013 and September 30, 2013, except as follows:
Gene by Gene LTD
Effective February 5, 2014, Myriad and the Patent Owners entered into a Settlement Agreement with Gene by Gene LTD whereby the parties have dismissed their respective claims and counterclaims against each other without prejudice. Under the agreement, Gene by Gene has agreed to cease selling or marketing clinical diagnostic tests within North America that include analysis of the BRCA1 and/or BRCA2 genes as a standalone test or in conjunction with gene panels, but Gene by Gene may continue to offer such tests outside of North America. The agreement will continue until the earlier of February 12, 2016 or the last-to-expire valid patent claim in any of the BRCA patents involved in the case.
In re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (MDL No. 2510)
On February 19, 2014, the United States Judicial Panel on Multi-District Litigation issued a Transfer Order whereby the legal proceedings involving Ambry Genetics Corporation, Counsyl, Inc., Quest Diagnostics Incorporated and Quest Diagnostics Nichols Institute, and GeneDX, Inc. have been transferred to the United States District Court for the District of Utah for coordinated and consolidated pretrial proceedings. Subsequent to the Transfer Order, the legal proceedings involving Invitae Corporation and Laboratory Corporation of America Holdings have also been transferred to the United States District Court for the District of Utah for coordinated and consolidated pretrial proceedings. The consolidated cases are now proceeding forward in the Utah District Court.
Ambry Genetics Corporation
On March 10, 2014, the United States District Court for the District of Utah denied our motion for a preliminary injunction against Ambry Genetics Corporation, finding that the Ambry had raised a substantial question concerning whether the Patent Owners primer and method claims are directed toward patent-ineligible products of nature and abstract ideas under 35 U.S.C. Section 101. Myriad and the other Patent Owners appealed the District Courts order to the United States Court of Appeals for the Federal Circuit and on April 18, 2014, and filed an opening brief requesting that the order be reversed and vacated and the case remanded for further proceedings. Ambrys respondents brief is due on June 2, 2014. A date for oral arguments has not yet been scheduled.
Other than as set forth above, we are not a party to any legal proceedings that we believe will have a material impact on our business, financial position or results of operations.
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Item 1A. Risk Factors
There have been no material changes to the risk factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2013.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Issuer Purchases of Equity Securities
In November 2013, our board of directors authorized a new stock repurchase program for $300 million. We are authorized to complete the repurchase from time to time or on an accelerated basis through open market transactions or privately negotiated transactions as determined by the Companys management. The amount and timing of stock repurchases under the program will depend on business and market conditions, stock price, trading restrictions, acquisition activity and other factors.
The details of the activity under our stock repurchase program during the fiscal quarter ended March 31, 2014 were as follows:
Period
January 1, 2014 to January 31, 2014
February 1, 2014 to February 28, 2014
March 1, 2014 to March 31, 2014
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Item 5. Other Information.
Item 6. Exhibits.
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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 thereunto duly authorized.
/s/ Peter D. Meldrum
/s/ James S. Evans
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