UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2012
OR
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 0-26642
MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 87-0494517 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
320 Wakara Way, Salt Lake City, UT | 84108 | |
(Address of principal executive offices) | (Zip Code) |
(801) 584-3600
Registrants telephone number, including area code:
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:
Large accelerated filer | x | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ (Do not check if smaller reporting company) | Smaller reporting company | ¨ |
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 April 27, 2012 the registrant had 84,865,995 shares of $0.01 par value common stock outstanding.
MYRIAD GENETICS, INC.
INDEX TO FORM 10-Q
2
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands, except per share amounts) | March 31, 2012 | June 30, 2011 | ||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 104,852 | $ | 52,681 | ||||
Marketable investment securities |
232,512 | 293,776 | ||||||
Prepaid expenses |
2,154 | 2,949 | ||||||
Inventory |
10,383 | 8,218 | ||||||
Trade accounts receivable, less allowance for doubtful accounts of $4,300 at Mar. 31, 2012 and $3,700 at Jun. 30, 2011 |
50,948 | 50,272 | ||||||
Deferred taxes |
5,686 | 9,790 | ||||||
Prepaid taxes |
10,633 | | ||||||
Other receivables |
1,501 | 575 | ||||||
|
|
|
|
|||||
Total current assets |
418,669 | 418,261 | ||||||
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|
|
|
|||||
Equipment and leasehold improvements: |
||||||||
Equipment |
52,991 | 46,912 | ||||||
Leasehold improvements |
17,773 | 17,201 | ||||||
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|
|
|
|||||
70,764 | 64,113 | |||||||
Less accumulated depreciation |
46,663 | 41,033 | ||||||
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|
|
|
|||||
Net equipment and leasehold improvements |
24,101 | 23,080 | ||||||
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|
|
|
|||||
Long-term marketable investment securities |
129,346 | 70,857 | ||||||
Long-term deferred taxes |
27,964 | 25,863 | ||||||
Note receivable (see Note 12) |
18,333 | | ||||||
Other assets (see Note 12) |
8,000 | | ||||||
Intangibles, net |
15,990 | 16,715 | ||||||
Goodwill |
56,850 | 56,051 | ||||||
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|
|
|
|||||
Total assets |
$ | 699,253 | $ | 610,827 | ||||
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|
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|
|||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 7,939 | $ | 11,395 | ||||
Accrued liabilities |
27,726 | 21,645 | ||||||
Deferred revenue |
1,387 | 1,347 | ||||||
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|
|
|
|||||
Total current liabilities |
37,052 | 34,387 | ||||||
|
|
|
|
|||||
Unrecognized tax benefits |
10,008 | 9,648 | ||||||
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|
|
|
|||||
Total liabilities |
47,060 | 44,035 | ||||||
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|
|
|
|||||
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 Mar. 31 , 2012 and Jun. 30, 2011, issued and outstanding 84,544 at Mar. 31, 2012 and 86,244 at Jun. 30, 2011 |
845 | 862 | ||||||
Additional paid-in capital |
651,535 | 604,409 | ||||||
Accumulated other comprehensive (loss) income |
(99 | ) | 151 | |||||
Accumulated deficit |
(88 | ) | (38,630 | ) | ||||
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|
|
|
|||||
Total stockholders equity |
652,193 | 566,792 | ||||||
|
|
|
|
|||||
$ | 699,253 | $ | 610,827 | |||||
|
|
|
|
See accompanying notes to condensed consolidated financial statements (unaudited).
3
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED INCOME STATEMENTS (UNAUDITED)
Three Months Ended | Nine Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
(In thousands, except per share amounts) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Molecular diagnostic testing |
$ | 123,312 | $ | 102,374 | $ | 344,891 | $ | 294,672 | ||||||||
Companion diagnostic services |
6,465 | | 18,149 | | ||||||||||||
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|
|
|
|
|
|
|
|||||||||
Total revenue |
129,777 | 102,374 | 363,040 | 294,672 | ||||||||||||
Costs and expenses: |
||||||||||||||||
Cost of molecular diagnostic testing |
13,465 | 11,133 | 37,580 | 34,191 | ||||||||||||
Cost of companion diagnostic services |
3,763 | | 10,127 | | ||||||||||||
Research and development expense |
11,753 | 6,667 | 30,502 | 18,520 | ||||||||||||
Selling, general, and administrative expense |
54,700 | 42,750 | 151,799 | 125,960 | ||||||||||||
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|
|
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|
|||||||||
Total costs and expenses |
83,681 | 60,550 | 230,008 | 178,671 | ||||||||||||
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|
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Operating income |
46,096 | 41,824 | 133,032 | 116,001 | ||||||||||||
Other income (expense): |
||||||||||||||||
Interest income |
1,379 | 547 | 3,235 | 1,816 | ||||||||||||
Other |
6 | (59 | ) | (199 | ) | (273 | ) | |||||||||
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|
|
|
|
|
|||||||||
Total other income |
1,385 | 488 | 3,036 | 1,543 | ||||||||||||
Income before income taxes |
47,481 | 42,312 | 136,068 | 117,544 | ||||||||||||
Income tax provision |
17,866 | 14,372 | 53,059 | 42,874 | ||||||||||||
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|
|||||||||
Net income |
$ | 29,615 | $ | 27,940 | $ | 83,009 | $ | 74,670 | ||||||||
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Earnings per share: |
||||||||||||||||
Basic |
$ | 0.35 | $ | 0.32 | $ | 0.98 | $ | 0.82 | ||||||||
Diluted |
$ | 0.34 | $ | 0.31 | $ | 0.96 | $ | 0.80 | ||||||||
Weighted average shares outstanding |
||||||||||||||||
Basic |
84,403 | 88,206 | 84,715 | 91,019 | ||||||||||||
Diluted |
86,462 | 90,127 | 86,537 | 92,846 |
See accompanying notes to condensed consolidated financial statements (unaudited).
4
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
Nine Months Ended March 31, |
||||||||
(In thousands) | 2012 | 2011 | ||||||
Cash flows from operating activities: |
||||||||
Net income |
$ | 83,009 | $ | 74,670 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: |
||||||||
Depreciation and amortization |
6,741 | 5,341 | ||||||
Loss of disposition on assets |
206 | |||||||
Share-based compensation expense |
19,859 | 18,715 | ||||||
Bad debt expense |
17,491 | 12,337 | ||||||
Non-cash expense related to in-process research and development technology |
750 | 1,500 | ||||||
Accreted interest on note receivable (see Note 12) |
(1,333 | ) | | |||||
Unrecognized tax benefits |
560 | (348 | ) | |||||
Excess tax benefit from share-based compensation |
(32,197 | ) | (44,182 | ) | ||||
Deferred income taxes |
34,199 | 39,591 | ||||||
(Gain) loss on sale of marketable investment securities |
(566 | ) | 35 | |||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses |
781 | 1,819 | ||||||
Trade accounts receivable |
(18,186 | ) | (10,972 | ) | ||||
Other receivables |
(1,152 | ) | (951 | ) | ||||
Prepaid taxes |
(10,633 | ) | | |||||
Inventory |
(2,180 | ) | | |||||
Accounts payable |
(3,456 | ) | (3,679 | ) | ||||
Accrued liabilities |
6,150 | 581 | ||||||
Deferred revenue |
63 | | ||||||
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|
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Net cash provided by operating activities |
100,106 | 94,457 | ||||||
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Cash flows from investing activities: |
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Capital expenditures for equipment and leasehold improvements |
(7,216 | ) | (3,182 | ) | ||||
Acquisition of Myriad RBM, Inc. |
(799 | ) | | |||||
Crescendo purchase option (see Note 12) |
(8,000 | ) | | |||||
Issuance of note receivable (see Note 12) |
(17,000 | ) | | |||||
Purchase of in-process research and development technology |
(750 | ) | (1,500 | ) | ||||
Purchase of other assets |
(100 | ) | (100 | ) | ||||
Purchases of marketable investment securities |
(290,854 | ) | (338,963 | ) | ||||
Proceeds from maturities and sales of marketable investment securities |
294,005 | 350,293 | ||||||
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Net cash (used in) provided by investing activities |
(30,714 | ) | 6,548 | |||||
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Cash flows from financing activities: |
||||||||
Net proceeds from common stock issued under share-based compensation plans |
18,058 | 7,958 | ||||||
Excess tax benefit from share-based compensation |
32,197 | 44,182 | ||||||
Repurchase and retirement of common stock |
(67,471 | ) | (178,607 | ) | ||||
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Net cash used in financing activities |
(17,216 | ) | (126,467 | ) | ||||
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Effect of foreign exchange rates on cash and cash equivalents |
(5 | ) | | |||||
Net increase (decrease) in cash and cash equivalents |
52,171 | (25,462 | ) | |||||
Cash and cash equivalents at beginning of period |
52,681 | 92,840 | ||||||
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Cash and cash equivalents at end of period |
$ | 104,852 | $ | 67,378 | ||||
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See accompanying notes to condensed consolidated financial statements (unaudited).
5
MYRIAD GENETICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(1) | Basis of Presentation |
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, Myriad Genetic Laboratories, Inc., Myriad RBM, Inc., Myriad GmbH (Germany), Myriad Genetics GmbH (Switzerland), Myriad Genetics SAS (France), Myriad Genetics S.r.l. (Italy), Myriad Financial, Inc., Myriad Crescendo, Inc. and Myriad Therapeutics, Inc. 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, 2011, included in the Companys Annual Report on Form 10-K for the fiscal year ended June 30, 2011. Operating results for the three and nine months ended March 31, 2012 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 revenues 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.
(2) | Recent Accounting Pronouncements |
In September 2011, the Financial Accounting Standards Board (FASB) issued additional guidance regarding testing goodwill for impairment. The guidance provides an entity the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events or circumstances, an entity determines it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing the two-step impairment test is not required. This guidance is effective for fiscal year 2013. Early adoption is permitted. The Company plans to early adopt and apply the guidance to its fiscal 2012 annual goodwill assessment.
(3) | Marketable Investment Securities |
The Company has classified its marketable investment securities as available-for-sale. 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 income 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.
6
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, 2012 and June 30, 2011 were as follows (in thousands):
Amortized cost |
Gross unrealized holding gains |
Gross unrealized holding losses |
Estimated fair value |
|||||||||||||
At March 31, 2012: |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Cash |
$ | 52,059 | $ | | $ | | $ | 52,059 | ||||||||
Cash equivalents |
52,793 | | | 52,793 | ||||||||||||
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Total cash and cash equivalents |
104,852 | | | 104,852 | ||||||||||||
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Available-for-sale: |
||||||||||||||||
Corporate bonds and notes |
259,520 | 218 | (66 | ) | 259,672 | |||||||||||
Federal agency issues |
100,833 | 43 | (40 | ) | 100,836 | |||||||||||
Auction rate securities |
1,500 | | (150 | ) | 1,350 | |||||||||||
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Total available-for-sale |
361,853 | 261 | (256 | ) | 361,858 | |||||||||||
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Total cash, cash equivalents & available-for-sale |
$ | 466,705 | $ | 261 | $ | (256 | ) | $ | 466,710 | |||||||
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Amortized cost |
Gross unrealized holding gains |
Gross unrealized holding losses |
Estimated fair value |
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At June 30, 2011: |
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Cash and cash equivalents: |
||||||||||||||||
Cash |
$ | 24,012 | $ | | $ | | $ | 24,012 | ||||||||
Cash equivalents |
28,679 | | (10 | ) | 28,669 | |||||||||||
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Total cash and cash equivalents |
52,691 | | (10 | ) | 52,681 | |||||||||||
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Available-for-sale: |
||||||||||||||||
Corporate bonds and notes |
212,056 | 307 | (10 | ) | 212,353 | |||||||||||
Federal agency issues |
150,832 | 118 | (20 | ) | 150,930 | |||||||||||
Auction rate securities |
1,500 | | (150 | ) | 1,350 | |||||||||||
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Total available-for-sale |
364,388 | 425 | (180 | ) | 364,633 | |||||||||||
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Total cash, cash equivalents & available-for-sale |
$ | 417,079 | $ | 425 | $ | (190 | ) | $ | 417,314 | |||||||
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Cash, cash equivalents, and maturities of debt securities classified as available-for-sale are as follows at March 31, 2012 (in thousands):
Amortized cost |
Estimated fair value |
|||||||
Cash |
$ | 52,059 | $ | 52,059 | ||||
Cash equivalents |
52,793 | 52,793 | ||||||
Available-for-sale: |
||||||||
Due within one year |
232,382 | 232,512 | ||||||
Due after one year through five years |
127,971 | 127,996 | ||||||
Due after five years |
1,500 | 1,350 | ||||||
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$ | 466,705 | $ | 466,710 | |||||
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7
(4) | Share-Based Compensation |
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. As of March 31, 2012, a total of 19,106,000 shares of common stock are reserved for issuance under the 2010 Plan. This number consists of 7,000,000 shares approved by the Companys stockholders and 902,000 shares transferred into the 2010 Plan which were cancelled or expired under the Companys 2003 Employee, Director and Consultant Option Plan (the 2003 Plan) and 2002 Amended and Restated Employee, Director and Consultant Stock Option Plan (the 2002 Plan). In addition, as of March 31, 2012, the Company may grant up to 11,204,000 additional shares under the 2010 Plan if options previously granted under the 2002 Plan or 2003 Plan are cancelled or expire in the future 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 plans generally vest ratably over four years and expire ten years from the date of grant. The exercise price of options granted is equivalent to the fair market value of the stock on the date of grant. The Company also has an Employee Stock Purchase Plan ( the Purchase Plan) under which 2,000,000 shares of common stock have been authorized and, as of March 31, 2012, a total of 1,820,000 shares of common stock had been issued under the Purchase Plan. Shares are issued under the Purchase Plan twice yearly at the end of each six month offering period. During the three and nine months ended March 31, 2012, the Company issued 0 and 74,000 shares of common stock under the Purchase Plan.
A summary of the stock option activity under the plans for the nine months ended March 31, 2012 is as follows:
Number of shares |
Weighted average exercise price |
|||||||
Options outstanding at June 30, 2011 |
14,453,913 | $ | 18.22 | |||||
Options granted |
3,145,160 | 20.37 | ||||||
Less: |
||||||||
Options exercised |
(1,339,980 | ) | 12.48 | |||||
Options canceled or expired |
(460,866 | ) | 21.10 | |||||
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Options outstanding at March 31, 2012 |
15,798,227 | $ | 19.05 | |||||
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|
As of March 31, 2012, options to purchase 8,894,000 shares were vested and exercisable at a weighted average price of $17.58. As of March 31, 2012, there was $40,199,000 of total unrecognized share-based compensation cost related to share-based awards granted under the Companys plans that will be recognized over a weighted-average period of 2.6 years.
Share-based compensation expense recognized and included in the consolidated income statements was allocated as follows:
8
Three months ended March 31, |
Nine months ended March 31, |
|||||||||||||||
(In thousands) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Cost of molecular diagnostic testing |
$ | 285 | $ | 301 | $ | 878 | $ | 897 | ||||||||
Cost of companion diagnostic services |
20 | | 39 | | ||||||||||||
Research and development expense |
818 | 865 | 2,574 | 2,926 | ||||||||||||
Selling, general, and administrative expense |
5,465 | 5,059 | 16,368 | 14,892 | ||||||||||||
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Total share-based compensation expense |
$ | 6,588 | $ | 6,225 | $ | 19,859 | $ | 18,715 | ||||||||
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|
(5) | Stockholders Equity |
Comprehensive Income
The components of the Companys comprehensive income are as follows:
Three months ended March 31, |
Nine months ended March 31, |
|||||||||||||||
(In thousands) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Net income |
$ | 29,615 | $ | 27,940 | $ | 83,009 | $ | 74,670 | ||||||||
Unrealized gain (loss) on available-for-sale securities, net of tax |
63 | 1 | (138 | ) | (39 | ) | ||||||||||
Change in foreign currency translation adjustment |
91 | | (112 | ) | | |||||||||||
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|||||||||
Comprehensive income |
$ | 29,769 | $ | 27,941 | $ | 82,759 | $ | 74,631 | ||||||||
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Stock Repurchase Program
The Company previously announced the following stock repurchase programs for its common stock:
Date Authorized |
Amount Authorized | Date Completed | ||||||||
May 2010 |
$ | 100,000,000 | August 2010 | |||||||
August 2010 |
$ | 100,000,000 | February 2011 | |||||||
March 2011 |
$ | 100,000,000 | September 2011 | |||||||
August 2011 |
$ | 200,000,000 | ongoing | |||||||
|
|
|||||||||
Total: |
$ | 500,000,000 |
The current $200,000,000 share repurchase program may be made through open market or privately negotiated purchases, either from time to time or on an accelerated basis, in each case to be executed at managements discretion based on market conditions.
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 accumulated deficit. The shares retired, aggregate common stock and additional paid-in capital reductions, and related charges to accumulated deficit for the repurchases for the three and nine months ended March 31, 2012 and 2011, were as follows:
9
Three months ended March 31, |
Nine months ended March 31, |
|||||||||||||||
(In thousands) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Shares purchased and retired |
502 | 4,493 | 3,114 | 9,119 | ||||||||||||
Common stock and additional paid-in-capital reductions |
$ | 3,732 | $ | 32,708 | $ | 23,004 | $ | 66,320 | ||||||||
Charges to accumulated deficit |
$ | 8,273 | $ | 55,361 | $ | 44,468 | $ | 112,286 |
(6) | Earnings Per Share |
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 common stock equivalents outstanding. Certain common shares consisting of stock options that would have an anti-dilutive effect were not included in the diluted earnings per share for the three and nine months ended March 31, 2012 and 2011.
The following is a reconciliation of the denominators of the basic and diluted earnings per share computations:
Three months ended March 31, |
Nine months ended March 31, |
|||||||||||||||
(In thousands) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Denominator: |
||||||||||||||||
Weighted-average shares outstanding used to compute basic earnings per share |
84,403 | 88,206 | 84,715 | 91,019 | ||||||||||||
Effect of dilutive stock options |
2,059 | 1,921 | 1,822 | 1,827 | ||||||||||||
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Weighted-average shares outstanding and dilutive securities used to compute dilutive earnings per share |
86,462 | 90,127 | 86,537 | 92,846 | ||||||||||||
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Certain outstanding stock options were excluded from the computation of diluted earnings per share 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:
Three months ended March 31, |
Nine months ended, March 31, |
|||||||||||||||
(In thousands) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Anti-dilutive options excluded from EPS computation |
7,589 | 8,767 | 8,639 | 8,648 |
(7) | Segment and Related Information |
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 companion diagnostics segment provides testing products and services to the pharmaceutical, biotechnology and medical research industries.
10
The Company evaluates segment performance based on results from operations before interest income and expense and other income and expense.
(In thousands) | Research | Molecular diagnostics |
Companion diagnostics |
Total | ||||||||||||
Three months ended March 31, 2012: |
||||||||||||||||
Revenue |
$ | | $ | 123,312 | $ | 6,465 | $ | 129,777 | ||||||||
Depreciation and amortization |
567 | 1,310 | 426 | 2,303 | ||||||||||||
Segment operating income (loss) |
(15,199 | ) | 63,282 | (1,987 | ) | 46,096 | ||||||||||
Three months ended March 31, 2011: |
||||||||||||||||
Revenue |
$ | | $ | 102,374 | $ | | $ | 102,374 | ||||||||
Depreciation and amortization |
513 | 1,287 | | 1,800 | ||||||||||||
Segment operating income (loss) |
(12,571 | ) | 54,395 | | 41,824 | |||||||||||
Nine months ended March 31, 2012: |
||||||||||||||||
Revenue |
$ | | $ | 344,891 | $ | 18,149 | $ | 363,040 | ||||||||
Depreciation and amortization |
1,591 | 3,909 | 1,241 | 6,741 | ||||||||||||
Segment operating income (loss) |
(40,500 | ) | 179,200 | (5,668 | ) | 133,032 | ||||||||||
Nine months ended March 31, 2011: |
||||||||||||||||
Revenue |
$ | | $ | 294,672 | $ | | $ | 294,672 | ||||||||
Depreciation and amortization |
1,484 | 3,857 | | 5,341 | ||||||||||||
Segment operating income (loss) |
(35,276 | ) | 151,277 | | 116,001 |
Three months ended March 31, |
Nine months ended March 31, |
|||||||||||||||
(In thousands) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Total operating income for reportable segments |
$ | 46,096 | $ | 41,824 | $ | 133,032 | $ | 116,001 | ||||||||
Interest income |
1,379 | 547 | 3,235 | 1,816 | ||||||||||||
Other |
6 | (59 | ) | (199 | ) | (273 | ) | |||||||||
Income tax provision |
17,866 | 14,372 | 53,059 | 42,874 | ||||||||||||
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|
|
|
|
|
|
|
|||||||||
Net income |
$ | 29,615 | $ | 27,940 | $ | 83,009 | $ | 74,670 | ||||||||
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|
|
|
|
|
|
(8) | Fair Value Measurements |
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 paid 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:
Level 1quoted prices in active markets for identical assets and liabilities.
Level 2 observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Companys marketable securities primarily utilize broker quotes in a non-active market for valuation of these securities.
Level 3unobservable inputs.
The substantial majority of the Companys financial instruments are valued using quoted prices in active markets or based on other observable inputs. The following table sets forth the fair value of the financial assets that the Company re-measured:
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(In thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
at March 31, 2012 |
||||||||||||||||
Money market funds (a) |
$ | 20,797 | $ | | $ | | $ | 20,797 | ||||||||
Corporate bonds and notes |
| 291,668 | | 291,668 | ||||||||||||
Federal agency issues |
| 100,836 | | 100,836 | ||||||||||||
Auction rate securities |
| | 1,350 | 1,350 | ||||||||||||
|
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|
|
|
|
|
|
|||||||||
Total |
$ | 20,797 | $ | 392,504 | $ | 1,350 | $ | 414,651 | ||||||||
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|
|
|
|
|
|
|||||||||
(In thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
at June 30, 2011 |
||||||||||||||||
Money market funds (a) |
$ | 9,680 | $ | | $ | | $ | 9,680 | ||||||||
Corporate bonds and notes |
| 222,352 | | 222,352 | ||||||||||||
Federal agency issues |
| 159,920 | | 159,920 | ||||||||||||
Auction rate securities |
| | 1,350 | 1,350 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 9,680 | $ | 382,272 | $ | 1,350 | $ | 393,302 | ||||||||
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|
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|
|
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(a) | Money market funds are primarily comprised of exchange traded funds and accrued interest |
(9) | Commitments and Contingencies |
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, 2012, 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.
(10) | Income Taxes |
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 and nine months ended March 31, 2012 was $17,866,000 and $53,059,000, respectively, or approximately 38% and 39% of pre-tax income, compared to $14,372,000 and $42,874,000, respectively, for the three and nine months ended March 31, 2011, or approximately 34% and 36% of pre-tax income. Income tax expense for the three and nine months ended March 31, 2012 is based on the Companys estimated annual effective tax rate for the full fiscal year ending June 30, 2012, adjusted by discrete items recognized during the period, such as research and development tax credits related to prior periods. The Companys effective tax rate differs from the U.S. federal statutory rate of 35% primarily due to state income taxes 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. As of March 31, 2012 the Company also had a $10,633,000 prepaid tax asset related to prepayments of the Companys estimated income tax obligation for fiscal year 2012.
The Company files U.S., U.K. and state income tax returns in jurisdictions with various statutes of limitations. The Companys New York State income tax returns for the years ended June 30, 2007, 2008 and 2009 are currently under examination by the New York State Department of Taxation and Finance. Annual and interim tax provisions include amounts considered necessary to pay assessments that may result from examination of prior year tax returns; however, the
12
amount ultimately paid upon resolution of issues may differ materially from the amount accrued. The Companys U.S. federal tax return, U.K. income tax return and all other state tax returns are not currently under examination.
(11) | Goodwill and Intangible Assets |
Goodwill
At March 31, 2012, the Company had recorded goodwill of $56,850,000 related to the acquisition of Myriad RBM, Inc. on May 31, 2011(formerly Rules-Based Medicine, Inc.). The Company recorded no impairment of goodwill for the three and nine months ended March 31, 2012.
Intangible Assets
Intangible assets primarily consist of amortizable assets of purchased licenses and technologies, and customer relationships as well as non-amortizable intangible assets of in-process research and development technologies, and trademarks. The following summarizes the amounts reported as intangible assets:
(In thousands) | Gross Carrying |
Accumlated | ||||||||||
March 31, 2012 | Amount | Amortization | Net | |||||||||
Purchased licenses and technologies |
$ | 6,500 | $ | (2,572 | ) | $ | 3,928 | |||||
Customer relationships |
4,650 | (388 | ) | 4,262 | ||||||||
|
|
|
|
|
|
|||||||
Total amortizable intangible assets |
11,150 | (2,960 | ) | 8,190 | ||||||||
|
|
|
|
|
|
|||||||
Trademarks |
3,000 | | 3,000 | |||||||||
In-process research and development |
4,800 | | 4,800 | |||||||||
|
|
|
|
|
|
|||||||
Total non-amortizable intangible assets |
7,800 | | 7,800 | |||||||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 18,950 | $ | (2,960 | ) | $ | 15,990 | |||||
|
|
|
|
|
|
|||||||
(In thousands) | Gross Carrying |
Accumlated | ||||||||||
June 30, 2011 | Amount | Amortization | Net | |||||||||
Purchased licenses and technologies |
$ | 6,400 | $ | (2,096 | ) | $ | 4,304 | |||||
Customer relationships |
4,650 | (39 | ) | 4,611 | ||||||||
|
|
|
|
|
|
|||||||
Total amortizable intangible assets |
11,050 | (2,135 | ) | 8,915 | ||||||||
|
|
|
|
|
|
|||||||
Trademarks |
3,000 | | 3,000 | |||||||||
In-process research and development |
4,800 | | 4,800 | |||||||||
|
|
|
|
|
|
|||||||
Total non-amortizable intangible assets |
7,800 | | 7,800 | |||||||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 18,850 | $ | (2,135 | ) | $ | 16,715 | |||||
|
|
|
|
|
|
The Company recorded amortization during the respective periods for these intangible assets as follows:
Three months ended March 31, |
Nine months ended March 31, |
|||||||||||||||
(In thousands) | 2012 | 2011 | 2012 | 2011 | ||||||||||||
Amortization on intangible assets |
$ | 275 | $ | 80 | $ | 825 | $ | 240 |
(10) | Term Loan and Option Agreement |
On September 8, 2011, the Company issued a $25,000,000 term loan to Crescendo Bioscience, Inc. (Crescendo) of South San Francisco, CA under a Loan and Security Agreement (Loan Agreement) and also secured an exclusive three-year option to acquire the company pursuant to a definitive merger agreement (the Option Agreement). Crescendo develops molecular diagnostic tests for patients suffering from autoimmune disorders, including rheumatoid arthritis.
13
Term Loan
Under the Loan Agreement, the Company has loaned Crescendo $25,000,000 for a term of six years, with the principal due upon maturity. Interest accrues at 6% per year and is due annually. In the event Crescendo defaults on the loan, additional interest will accrue at 5% per year. The loan will mature on the earlier of (i) September 8, 2017 or (ii) the third anniversary following the date that the Companys option to acquire Crescendo under the Option Agreement expires or; otherwise terminates under the terms of the agreement. The option can be accelerated by Crescendo as a result of (a) Crescendos delivery of an early termination notice due to the achievement of triggering events under the Option Agreement or (b) Crescendos delivery of an initial public offering notice under the Option Agreement. Crescendo has the right to prepay the entire loan amount plus accrued interest at any time without incurring a penalty.
Option Agreement
Under the Option Agreement, the Company has an exclusive three-year option, exercisable in the Companys sole discretion, to cause the closing of the merger if Crescendo attains a minimum revenue milestone during the three-year option term. If Crescendo attains the minimum revenue milestone, the purchase price to acquire Crescendo will be based on a predetermined multiple of revenue based on Crescendos growth rate at the time the option is exercised. If Crescendo does not attain the minimum revenue milestone during the three-year option term, the Company will have a one-time right to exercise the option at the end of the option term and acquire Crescendo at a fixed purchase price. In either case, the purchase price would be all cash and would be subject to adjustment for Crescendos cash, debt and other items at closing. If the Company exercises its option to purchase Crescendo, all amounts due under the term loan will be offset against the purchase price paid in the acquisition. The Option Agreement has received the requisite corporate approvals of both parties, including approval from Crescendos stockholders.
Because the option to purchase Crescendo is contingently exercisable by the Company under the Option Agreement, and repayment of the term loan will be accelerated if the option is exercised, the Company has recorded the Option Agreement at fair value as of September 8, 2011 in other assets on the condensed consolidated balance sheet. The fair value of the Option Agreement of $8,000,000 was determined utilizing valuation models, including the market and income based approaches, which utilize various inputs including projected income, volatility, risk free rates and projected terms. Under the applicable accounting guidance the Company has an initial policy decision to either re-value the Option Agreement each reporting period or carry the Option Agreement at the original recorded amount and periodically asses the Option Agreement for impairment. The Company has elected to periodically evaluate the Option Agreement for impairment. No impairment indicators were noted at March 31, 2012.
The residual $17,000,000 value of the term loan has been classified as a note receivable on the condensed consolidated balance sheet as of March 31, 2012. The Company recorded interest income related to accretion of the note receivable and the stated interest rate for the three and nine months ended March 31, 2012 of $1,042,000 and $2,208,000, respectively, in the condensed consolidated income statement. The Company is also utilizing the effective interest method to accrete the discount portion of the note receivable through interest income over the three-year term of the Companys option to acquire Crescendo under the Option Agreement. The note receivable is evaluated for collectability each reporting period. If the Company determines that the note receivable and any accrued interest is not collectible, such amount will be written off in the period that determination is made.
14
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
We are a leading molecular diagnostic company focused on developing and marketing novel predictive medicine, personalized medicine, and prognostic medicine tests. We perform all of the molecular diagnostic testing and analysis in our own reference laboratory. We believe that the future of medicine lies in a shift from a treatment paradigm to a prevention paradigm. By understanding the underlying genetic basis of disease, we believe that individuals who have a greater risk of developing disease can be identified and physicians can use this information to improve patient outcomes and better manage patient healthcare. In addition, by understanding the patients individual genetic makeup and specific cause of disease, we believe that our transformative products may assist physicians in better managing their patients healthcare to ensure that they receive the most appropriate therapy at an optimal dosing.
We employ a number of proprietary technologies, including DNA, RNA and protein analysis, that 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), or assess a patients risk of disease progression and disease recurrence (prognostic medicine).
Our goal is to provide physicians with critical information that may guide the healthcare management of their patients to diagnose the disease at an earlier stage when it may be treatable, determine the most appropriate therapy, assess the aggressiveness of their disease or even potentially prevent disease. Our business strategy for future growth is focused on three key initiatives. First, we are growing our existing products and markets. Second, we are expanding our business internationally and have recently established operations in Europe. Finally, we intend to launch new transformative products across a diverse set of disease indicators, complementing our current businesses in oncology, womens health and urology.
Products and Services
We offer nine commercial molecular diagnostic tests, including five predictive medicine tests, three personalized medicine tests, and one prognostic medicine test. We market these tests through our own sales force of approximately 360 people in the United States. We have also established offices in Paris, France; Madrid, Spain; Milan, Italy; laboratory operations and a sales and administrative office in Munich, Germany; and headquarters in Zurich, Switzerland. We intend to market our BRACAnalysis®, COLARIS®, and COLARIS AP® products through our own European sales force and have entered into marketing collaborations with other organizations in selected Latin American and Asian countries.
Total revenue was $129.8 million and $363.0 million for the three and nine months ended March 31, 2012, an increase of approximately 27% and 23% over revenues of $102.4 million and $294.7 million for the same periods in the prior year.
The nine commercial molecular diagnostic tests that we currently offer in the United States are:
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BRACAnalysis®, our predictive medicine test for hereditary breast and ovarian cancer; |
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COLARIS®, our predictive medicine test for hereditary colorectal and uterine cancer; |
| COLARIS AP®, our predictive medicine test for hereditary colorectal cancer; |
|
MELARIS®, our predictive medicine test for hereditary melanoma; |
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OnDose®, our personalized medicine test to measure chemotherapy exposure to 5-FU; |
| PANEXIA, our predictive medicine test for pancreatic cancer; |
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PREZEON®, our personalized medicine test to assess PTEN status for disease progression and drug response; |
|
Prolaris®, our prognostic medicine test for prostate cancer; and |
| Theraguide® 5-FU, our personalized medicine test for chemotherapy toxicity to 5-FU. |
15
Through our wholly owned subsidiary, Myriad RBM, Inc. (Myriad RBM), we analyze proteins, discover biomarkers and provide companion diagnostic services to the pharmaceutical, biotechnology, and medical research industries utilizing our multiplexed immunoassay technology. Our protein analytics technology enables us to efficiently screen large sets of well-characterized clinical samples from both diseased and non-diseased populations against our extensive menu of over 550 immunoassays. By analyzing the data generated from these analyses, we attempt to discover biomarker patterns that indicate a particular disease or disorder with a high degree of accuracy. In addition to the fees received from analyzing these samples, we also use this information to create and validate potential diagnostic test panels that can aid us in the development of potential new companion diagnostic tests. The information from these tests could aid physicians in making treatment decisions to improve the health care management of their patients. We recognized companion diagnostic service revenue of $6.5 million and $18.1 million during the three and nine months ended March 31, 2012.
Use of Resources
During the three and nine months ended March 31, 2012, we devoted substantially all of our resources to supporting our molecular diagnostic and companion diagnostic businesses, as well as to the research and development of future molecular and companion diagnostic opportunities. We also pursued in-licensing opportunities where we acquire rights to new products and technologies from third parties. We have three reportable operating segmentsresearch, molecular diagnostics and companion diagnostics. See Note 7 Segment and Related Information in the notes to our condensed consolidated financial statements (unaudited) for information regarding these operating segments.
For the three and nine months ended March 31, 2012, we had net income of $29.6 million and $83.0 million and diluted earnings per share of $0.34 and $0.96, compared to $27.9 million and $74.7 million and $0.31 and $0.80 per share in the same periods of the prior year. Net income and earnings per share results for the three and nine months ended March 31, 2012 included income tax expense of $17.9 million and $53.1 million compared to $14.4 million and $42.9 million for the same periods in the prior year. As of March 31, 2012, we had an accumulated deficit of $0.1 million.
Recent Developments
Between May 2010 and August 2011, we repurchased $300 million of our outstanding common stock. On August 15, 2011, our board of directors authorized us to repurchase an additional $200 million of our outstanding common stock. In connection with this latest stock repurchase authorization, we have been authorized to repurchase shares at managements discretion based on market conditions and have repurchased $39.5 million of our outstanding common stock. See also Part II, Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Issuer Purchases of Equity Securities.
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. Our critical accounting policies are noted below, along with the policies included in our Annual Report on Form 10-K, for the year ended June 30, 2011.
Impairment of Long-lived and Intangible Assets, Including Goodwill
Periodically we assess potential impairment of our long-lived assets, which include property, equipment and acquired intangible assets. We perform an impairment review whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors we consider important which could trigger an impairment review include, but are not limited to, significant under-performance relative to historical or projected future operating results, significant changes in the manner of our use of the acquired assets or our overall business strategy and significant industry or economic trends. When we determine that the carrying value of a long-lived asset may not be recoverable based upon the existence of
16
one or more of the above indicators, we determine the recoverability by comparing the carrying amount of the asset to net future undiscounted cash flows that the asset is expected to generate. We recognize an impairment charge equal to the amount by which the carrying amount exceeds the fair market value of the asset.
We test goodwill for impairment annually as of April 1, or whenever events or changes in circumstances indicate that goodwill may be impaired. We first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events or circumstances, we determine it is more likely than not that the fair value of a reporting unit is less than its carrying amount, then a second step is performed to compute the amount of impairment as the difference between the estimated fair value of goodwill and the carrying value.
Results of Operations for the Three Months Ended March 31, 2012 and 2011
Revenue
Revenue is comprised of sales of our molecular diagnostic tests and our companion diagnostic services. Total revenue for the three months ended March 31, 2012 was $129.8 million, compared to $102.4 million for the same three months in 2011. This 27% increase in revenue is primarily due to increased molecular diagnostic testing volume. Diagnostic service revenue from Myriad RBM also contributed 6% to the increase in revenue. We believe that increased sales, marketing, and education efforts resulted in wider acceptance of molecular diagnostic tests by the medical community and increased patient testing volumes. However, there can be no assurance that molecular diagnostic testing revenue or companion diagnostic service 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, 2012 and 2011 were as follows:
March 31, | % of Total Revenue | |||||||||||||||||||
(In thousands) | 2012 | 2011 | % Change | 2012 | 2011 | |||||||||||||||
Molecular diagnostic testing revenues: |
||||||||||||||||||||
BRACAnalysis |
$ | 105,894 | $ | 90,303 | 17 | % | 81 | % | 88 | % | ||||||||||
COLARIS & COLARIS AP |
11,189 | 7,414 | 51 | % | 9 | % | 7 | % | ||||||||||||
Other |
6,229 | 4,657 | 34 | % | 5 | % | 5 | % | ||||||||||||
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Total molecular diagnostic testing revenues |
123,312 | 102,374 | 20 | % | ||||||||||||||||
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Companion diagnostic service revenues (a) |
6,465 | | 100 | % | 5 | % | 0 | % | ||||||||||||
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Total revenues |
$ | 129,777 | $ | 102,374 | 27 | % | 100 | % | 100 | % | ||||||||||
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(a) | We began providing companion diagnostic services following our acquisition of Myriad RBM on May 31, 2011 |
17
Our molecular diagnostic sales force is focused on two major markets, oncology and womens health. Oncology and womens health revenues were 70.2% and 29.8% of total molecular diagnostic testing revenues, respectively. Sales of molecular diagnostic tests in each market for the three months ended March 31, 2012 and 2011 were as follows:
Three months ended March 31, |
||||||||||||
(In thousands) | 2012 | 2011 | % Change | |||||||||
Molecular diagnostic testing revenues: |
||||||||||||
Oncology |
$ | 86,612 | $ | 73,107 | 19 | % | ||||||
Womens health |
36,700 | 29,267 | 25 | % | ||||||||
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Total molecular diagnostic testing revenues |
$ | 123,312 | $ | 102,374 | 20 | % | ||||||
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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, 2012 was $13.5 million, compared to $11.1 million for the same three months in 2011. This increase of 21% in molecular diagnostic testing cost of revenue is primarily due to an increase in testing volumes. Our costs of companion diagnostic services include similar items. Cost of companion diagnostic services was $3.8 million for the three months ended March 31, 2012. Many of these costs associated with the performance of our companion diagnostic services are fixed; consequently, gross margins will vary as we experience fluctuations in our companion diagnostic service revenue.
Our cost of revenue may fluctuate from quarter to quarter based on the introduction of new molecular diagnostic tests, changes in companion diagnostic services, price changes of existing tests and services, changes in our costs associated with such tests and services, new technologies and operating systems to integrate into our molecular diagnostic laboratories and costs associated with operating additional laboratories outside the United States. There can be no assurance that gross profit margins will continue to increase or remain at current levels.
Our research and development expenses include costs incurred in maintaining and improving our nine current molecular diagnostic tests and costs incurred for the discovery, development and validation 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, 2012 were $11.8 million compared to $6.7 million for same three months in 2011. This increase of 76% was primarily due to the following:
| an increase of approximately $2.4 million in internal development activities and clinical studies to support our existing molecular diagnostic testing products; |
| the addition of $1.9 million in companion diagnostic discovery costs from Myriad RBM; and |
| an increase of approximately $0.8 million due to the internal development of future molecular diagnostic product candidates. |
We expect that our research and development expenses will increase 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 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, 2012 were $54.7 million, compared to $42.8 million for the same three months in 2011. The increase in selling, general and administrative expense of 28% was due primarily to support the 27% increase in revenue and include:
18
| an increase of approximately $3.1 million in bad debt expense; |
| the addition of $2.6 million of administrative costs from Myriad RBM; |
| an increase in sales and marketing expense of approximately $2.5 million due to various marketing initiatives and increased sales commissions; |
| an increase in share-based compensation expense of approximately $2.4 million; and |
| an increase of approximately $1.3 million in international administrative costs from our European operations. |
We expect that our selling, general and administrative expenses will continue to increase from quarter to quarter and that such increases may be substantial, depending on the number and scope of any new molecular diagnostic and companion diagnostic launches, our efforts in support of our existing molecular diagnostic tests and companion diagnostic services as well as our continued international expansion efforts.
Other Income (Expense)
Interest income for the three months ended March 31, 2012 was $1.4 million, compared to $0.5 million for the same three months in 2011. The increase was due primarily to interest income recorded from the note receivable from Crescendo.
Income Tax Provision
Income tax expense for the three months ended March 31, 2012 was $17.9 million, for an effective income tax rate of approximately 38%, compared to income tax expense of $14.4 million or a 34% effective income tax rate in the same period in 2011. Income tax expense for the three months ended March 31, 2012 is based on our estimated annual effective tax rate for the full fiscal year ending June 30, 2012 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 state and alternative minimum income taxes 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. Certain significant or unusual items are separately recognized during the quarter 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, 2012 and 2011
Revenue
Total revenue for the nine months ended March 31, 2012 was $363.0 million, compared to $294.7 million for the same nine months in 2011. This 23% increase in revenue is primarily due to increased molecular diagnostic testing volume. Diagnostic service revenue from Myriad RBM also contributed 6% to the increase in revenue.
19
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, 2012 and 2011 were as follows:
Nine months ended | ||||||||||||||||||||
March 31, | % of Total Revenue | |||||||||||||||||||
(In thousands) | 2012 | 2011 | % Change | 2012 | 2011 | |||||||||||||||
Molecular diagnostic testing revenues: |
||||||||||||||||||||
BRACAnalysis |
$ | 296,789 | $ | 260,156 | 14% | 82% | 89% | |||||||||||||
COLARIS & COLARIS AP |
31,736 | 21,543 | 47% | 9% | 7% | |||||||||||||||
Other |
16,366 | 12,973 | 26% | 4% | 4% | |||||||||||||||
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Total molecular diagnostic testing revenues |
344,891 | 294,672 | 17% | |||||||||||||||||
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Companion diagnostic service revenues |
18,149 | | 100% | 5% | 0% | |||||||||||||||
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Total revenues |
$ | 363,040 | $ | 294,672 | 23% | 100% | 100% | |||||||||||||
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Our molecular diagnostic sales force is focused on two major markets, oncology and womens health. Oncology and womens health revenues were 69.8% and 30.2% of total molecular diagnostic testing revenues, respectively. Sales of molecular diagnostic tests in each market for the nine months ended March 31, 2012 and 2011 were as follows:
Nine months ended | ||||||||||||
March 31, | ||||||||||||
(In thousands) | 2012 | 2011 | % Change | |||||||||
Molecular diagnostic testing revenues: |
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Oncology |
$ | 240,579 | $ | 208,588 | 15 | % | ||||||
Womens health |
104,312 | 86,084 | 21 | % | ||||||||
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Total molecular diagnostic testing revenues |
$ | 344,891 | $ | 294,672 | 17 | % | ||||||
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Costs and Expenses
Cost of molecular diagnostic testing revenue for the nine months ended March 31, 2012 was $37.6 million, compared to $34.2 million for the same nine months in 2011. This increase of 10% in molecular diagnostic testing cost of revenue is primarily due to an increase in testing volumes. Cost of companion diagnostic services was $10.1 million for the nine months ended March 31, 2012. Many of these costs associated with the performance of our companion diagnostic services are fixed; consequently, gross margins will vary as we experience fluctuations in our companion diagnostic service revenue.
Research and development expenses incurred during the nine months ended March 31, 2012 were $30.5 million compared to $18.5 million for same nine months in 2011. This increase of 65% was primarily due to the following:
| the addition of $5.5 million in companion diagnostic discovery costs from Myriad RBM; |
| an increase of approximately $4.5 million in internal development activities and clinical studies to support our existing molecular diagnostic testing products; |
| an increase of approximately $1.3 million due to the internal development of future molecular diagnostic product candidates; and |
| an increase of approximately $0.7 million due to the in-license of molecular diagnostic testing product candidates. |
Selling, general and administrative expenses for the nine months ended March 31, 2012 were $151.8 million, compared to $126.0 million for the same nine months in 2011. The increase in selling, general and administrative expense of 21% was due primarily to support the 23% increase in revenues and include:
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| the addition of approximately $8.0 million due to administrative costs from Myriad RBM; |
| an increase in sales and marketing expense of approximately $6.9 million due to various marketing initiatives and increased sales commissions; |
| an increase of approximately $5.1 million in bad debt expense; |
| an increase of approximately $2.8 million in international administrative costs from our European operations; |
| an increase of approximately $1.6 million in administrative costs, due to support of domestic market expansion; and |
| an increase in share-based compensation expense of approximately $1.4 million. |
Other Income (Expense)
Interest income for the nine months ended March 31, 2012 was $3.2 million, compared to $1.8 million for the same nine months in 2011. The increase was due primarily to interest income recorded from the note receivable from Crescendo.
Income Tax Provision
Income tax expense for the nine months ended March 31, 2012 was $53.1 million, for an effective income tax rate of approximately 39%, compared to income tax expense of $42.9 million or a 36% effective income tax rate in the same period in 2011. Income tax expense for the nine months ended March 31, 2012 is based on our estimated annual effective tax rate for the full fiscal year ending June 30, 2012 adjusted by discrete items recognized during the period.
Liquidity and Capital Resources
Cash, cash equivalents, and marketable investment securities increased $49.4 million, or 12%, to $466.7 million at March 31, 2012 from $417.3 million at June 30, 2011. This increase was attributable to increased sales, partially offset by purchasing $67.5 million of our common stock under our share repurchase programs, issuance of a $25 million note to Crescendo, payments of $25.8 million in estimated federal income tax obligations, and operating expenditures.
Net cash provided by operating activities was $100.1 million during the nine months ended March 31, 2012, compared to $94.5 million during the same nine months in 2011. Our net income was reduced by non-cash charges in the form of share-based compensation and depreciation and amortization, which totaled $19.9 million and $6.7 million, respectively, during the nine months ended March 31, 2012. Cash from operating activities also decreased by $10.6 million during the nine months ended March 31, 2012 due to payments of estimated income tax obligations.
Our investing activities used cash of $30.7 million during the nine months ended March 31, 2012 and provided cash of $6.5 million during the same nine months in 2011. Investing activities were comprised primarily of purchases and sales and maturities of marketable investment securities and the issuance of a $25.0 million loan to Crescendo. Capital expenditures for equipment and facilities for the nine months ended March 31, 2012 were $7.2 million.
Financing activities used cash of $17.2 million during the nine months ended March 31, 2012 and used cash of $126.5 million in the same nine months in 2011. Cash utilized in financing activities during the nine months ended March 31, 2012 was primarily due to the purchase of $67.5 million of our common stock through our share repurchase programs, partially offset by $18.1 million from cash provided by the exercise of stock options and $32.2 million from excess tax benefits received from share-based compensation.
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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 foreseeable future, 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 financing. 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:
| failure to sustain revenue growth or margins in our molecular diagnostic testing and companion diagnostic services businesses; |
| termination of the licenses underlying our molecular diagnostic tests and companion diagnostic services or failure to enter into product or technology licensing or other arrangements favorable to us; |
| delays or other problems with operating our laboratory facilities; |
| the costs and expenses incurred in supporting our existing molecular diagnostic tests and companion diagnostic services and expanding into foreign markets; |
| the progress, results and cost of developing and launching additional molecular diagnostic tests and offering additional companion diagnostic services; |
| potential business development activities, in-licensing agreements and acquisitions, such as our acquisition of Myriad RBM and our strategic debt investment and option to acquire Crescendo Biosciences, and our ability to successfully integrate and achieve the expected benefits of our business development activities, in-licensing agreements and acquisitions; |
| changes in the government regulatory approval process for our tests and services; |
| the progress, costs and results of our international expansion efforts; |
| the costs, timing, outcome, and enforcement of any regulatory review of our existing or future molecular diagnostic tests and companion diagnostic services; |
| the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our issued patents and defending intellectual property-related claims; |
| the costs, timing and outcome of any litigation against us; |
| the introduction of technological innovations or new commercial tests by our competitors; |
| changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic services and patents or enforcement in the United States and foreign countries; |
| changes in the governmental or private insurers reimbursement levels for our tests and services; and |
| changes in structure of the healthcare system or healthcare payment systems. |
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.
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
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increase at historical rates; 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 developments or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; our ability to obtain new corporate collaborations or licenses and acquire new technologies on satisfactory terms, if at all; our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; the development of competing tests and services; 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; 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, 2011, 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, 2012 compared to the disclosures in Part II, Item 7A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2011, which is incorporated by reference herein.
Item 4. | Controls and Procedures |
(a) | Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. |
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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(b) | Changes in Internal Controls. There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. |
Item 1. | Legal Proceedings |
We are a defendant in a lawsuit brought by the Association for Molecular Pathology, et al . (the Plaintiffs) on May 12, 2009 in the United States District Court for the Southern District of New York (the District Court) before Judge Robert W. Sweet. The Plaintiffs sought a declaratory ruling that 15 claims of seven patents relating to the BRCA1 and BRCA2 genes, which patents are exclusively licensed to us, are invalid and unenforceable, and enjoining us (and the other defendants) from taking any actions to enforce these claims of these patents. The 15 claims at issue in the lawsuit are part of the intellectual property relating to our BRACAnalysis predictive medicine test for breast and ovarian cancer. On April 19, 2010, Judge Sweet entered a judgment in this lawsuit ruling that these 15 claims at issue were invalid. On June 16, 2010, we filed a Notice to Appeal with the United States Court of Appeals for the Federal Circuit (the Court of Appeals) appealing the District Court decision. On July 29, 2011 the Court of Appeals reversed the District Courts decision, in part, holding that the nine composition claims relating to isolated DNA molecules and one method claim relating to screening potential cancer therapeutics via changes in cell growth rates are patent-eligible under 35 U.S.C. Section 101. However, the Court of Appeals affirmed the District Courts decision that the remaining five method claims directed to comparing or analyzing DNA sequences are patent ineligible. The Court of Appeals also affirmed the District Courts decision to exercise declaratory judgment jurisdiction. After the Court of Appeals issued its opinion, both parties requested, in part, a panel rehearing of the decision of the Court of Appeals. The Court of Appeals denied each partys request for a panel rehearing.
On December 7, 2011, Plaintiffs filed a Petition for a Writ of Certiorari with the Supreme Court of the United States (the Supreme Court), seeking the Supreme Courts review of the decision of the Court of Appeals as it pertains to the composition claims relating to isolated DNA molecules, and the Court of Appeals decision that 19 of the Plaintiffs lacked standing. On January 13, 2012, we filed our Brief in Opposition to the Plaintiffs Petition for a Writ of Certiorari. On March 26, 2012 the Supreme Court granted the Plaintiffs Petition for a Writ of Certiorari, vacated the Court of Appeals decision, and remanded the case back to the Court of Appeals for reconsideration in light of the Supreme Courts decision in Mayo v. Prometheus Laboratories on March 20, 2012. Accordingly, the Court of Appeals will now reconsider its decision dated July 29, 2011. The Court of Appeals has not yet provided a schedule for the matter to be reconsidered.
Apart from the 15 claims being challenged in this lawsuit, there are 164 separate claims under these seven patents which also cover the intellectual property utilized in, or related to, our BRACAnalysis predictive medicine test for breast and ovarian cancer which are not subject to this lawsuit. Additionally, there are 17 other issued U.S. patents which also cover the intellectual property utilized in, or related to, our BRACAnalysis predictive medicine test for breast and ovarian cancer which are not subject to this lawsuit. Accordingly, we do not believe that this lawsuit will have a material adverse impact on the Company even if we do not ultimately prevail.
We are not a party to any other legal proceedings that we believe will have a material impact on our business, financial position or results of operations.
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, 2011, as updated in our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2011.
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. |
Issuer Purchases of Equity Securities
We have previously announced the following stock repurchase programs for repurchases of our common stock:
Date Authorized |
Amount Authorized | Date Completed | ||
May 2010 |
$100 million | August 2011 | ||
August 2010 |
$100 million | February 2011 | ||
March 2011 |
$100 million | September 2011 | ||
August 2011 |
$200 million | ongoing | ||
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Total: |
$500 million |
In connection with our most recent stock repurchase authorization, we have been authorized to complete the repurchase through open market transactions or through an accelerated share repurchase program, in each case to be executed at managements discretion based on market conditions. As of the date of this report, we have not entered into an accelerated share repurchase agreement under our most recent stock repurchase program.
The details of the activity under our stock repurchase programs during the fiscal quarter ended March 31, 2012, were as follows:
Issuer Purchases of Equity Securities
(a) | (b) | (c) | (d) | |||||||||||||
Period |
Total Number of Shares Purchased |
Average Price Paid per Share |
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs |
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs |
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January 1, 2012 to January 31, 2012 |
| $ | | | $ | 172,650,855 | ||||||||||
February 1, 2012 to February 29, 2012 |
252,636 | $ | 23.75 | 252,636 | 166,649,519 | |||||||||||
March 1, 2012 to March 31, 2012 |
249,372 | $ | 24.08 | 249,372 | 160,645,648 | |||||||||||
Total |
502,008 | 502,008 | $ | 160,645,648 |
Item 3. | Defaults Upon Senior Securities. |
None.
Item 4. | Mine Safety Disclosures. |
None.
Item 5. | Other Information. |
None.
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Item 6. | Exhibits. |
31.1 | Certification of Chief Executive Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of Chief Financial Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
101@ | The following materials from Myriad Genetics, Inc.s Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, formatted in XBRL (Extensible Business Reporting Language): (i) the unaudited Condensed Consolidated Balance Sheets, (ii) the unaudited Condensed Consolidated Statements of Income, (iii) the unaudited Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Condensed Consolidated Financial Statements. |
@ | Users of the XBRL data are advised pursuant to Rule 406T of Regulation S-T that this interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections. |
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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.
MYRIAD GENETICS, INC. | ||||||
Date: May 2, 2012 | By: | /s/ Peter D. Meldrum | ||||
Peter D. Meldrum | ||||||
President and Chief Executive Officer | ||||||
(Principal executive officer) |
Date: May 2, 2012 | By: | /s/ James S. Evans | ||||
James S. Evans | ||||||
Chief Financial Officer | ||||||
(Principal financial and chief accounting officer) |
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