Document
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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ý | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2018
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¨ | 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: 001-35006
SPECTRUM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware | | 93-0979187 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
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11500 South Eastern Avenue, Suite 240 Henderson, Nevada | | 89052 |
(Address of principal executive offices) | | (Zip Code) |
(702) 835-6300
(Registrant’s 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 ý 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 during the preceding 12 months (or for such shorter period that the Registrant was required to submit and post such files). Yes ý No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. |
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Large accelerated filer | | ¨ | | Accelerated filer | | ý |
Non-accelerated filer | | ¨ (Do not check if a smaller reporting company) | | Smaller reporting company | | ¨ |
| | | | Emerging Growth Company | | ¨ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No ý
As of July 31, 2018, 105,958,838 shares of the registrant’s common stock were outstanding.
SPECTRUM PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2018
TABLE OF CONTENTS |
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Item | | Page |
| PART I. FINANCIAL INFORMATION | |
Item 1. | Condensed Consolidated Financial Statements (unaudited): | |
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Item 2. | | |
Item 3. | | |
Item 4. | | |
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| PART II. OTHER INFORMATION | |
Item 1. | | |
Item 1A. | | |
Item 6. | | |
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Items 2 through 5 of Part II have been omitted because they are not applicable with respect to the current reporting period.
SPECTRUM PHARMACEUTICALS, INC. ®, FUSILEV®, FOLOTYN®, ZEVALIN®, MARQIBO®, BELEODAQ® , EVOMELA®, and ROLONTIS® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. QAPZOLA™, REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals’ logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
PART I: FINANCIAL INFORMATION
ITEM 1: CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SPECTRUM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and par value amounts)
(Unaudited) |
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| June 30, 2018 | | December 31, 2017 |
ASSETS |
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Current assets: |
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Cash and cash equivalents | $ | 174,371 |
| | $ | 227,323 |
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Marketable securities | 95,287 |
| | 248 |
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Accounts receivable, net of allowance for doubtful accounts of $70 and $71, respectively | 27,658 |
| | 32,260 |
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Other receivables | 2,915 |
| | 2,133 |
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Inventories | 4,520 |
| | 5,715 |
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Prepaid expenses and other assets | 4,769 |
| | 10,067 |
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Total current assets | 309,520 |
| | 277,746 |
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Property and equipment, net of accumulated depreciation | 523 |
| | 589 |
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Intangible assets, net of accumulated amortization | 123,214 |
| | 137,159 |
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Goodwill | 18,106 |
| | 18,162 |
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Other assets | 13,159 |
| | 53,783 |
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Total assets | $ | 464,522 |
| | $ | 487,439 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable and other accrued liabilities | $ | 49,886 |
| | $ | 58,117 |
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Accrued payroll and benefits | 4,946 |
| | 9,261 |
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Deferred revenue | — |
| | 3,872 |
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FOLOTYN development liability | 211 |
| | 275 |
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Convertible senior notes | 39,427 |
| | 38,224 |
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Total current liabilities | 94,470 |
| | 109,749 |
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FOLOTYN development liability, less current portion | 11,980 |
| | 12,111 |
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Deferred revenue, less current portion | — |
| | 315 |
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Acquisition-related contingent obligations | 6,755 |
| | 6,272 |
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Deferred tax liabilities | 1,447 |
| | 1,438 |
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Other long-term liabilities | 5,751 |
| | 6,215 |
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Total liabilities | 120,403 |
| | 136,100 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding | — |
| | — |
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Common stock, $0.001 par value; 300,000,000 shares authorized; 105,130,603 and 100,742,735 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 103 |
| | 100 |
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Additional paid-in capital | 829,052 |
| | 837,347 |
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Accumulated other comprehensive (loss) income | (3,088 | ) | | 15,999 |
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Accumulated deficit | (481,948 | ) | | (502,107 | ) |
Total stockholders’ equity | 344,119 |
| | 351,339 |
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Total liabilities and stockholders’ equity | $ | 464,522 |
| | $ | 487,439 |
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See accompanying notes to these unaudited condensed consolidated financial statements.
SPECTRUM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
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| | | | | | | | | | | | | | | |
| Three Months Ended June 30, |
| Six Months Ended June 30, |
| 2018 |
| 2017 |
| 2018 |
| 2017 |
Revenues: |
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Product sales, net | $ | 23,753 |
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| $ | 31,156 |
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| $ | 51,863 |
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| $ | 57,001 |
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License fees and service revenue | 415 |
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| 3,145 |
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| 2,799 |
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| 6,401 |
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Total revenues | $ | 24,168 |
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| $ | 34,301 |
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| $ | 54,662 |
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| $ | 63,402 |
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Operating costs and expenses: |
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Cost of sales (excludes amortization of intangible assets) | 6,606 |
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| 11,303 |
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| 13,420 |
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| 19,439 |
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Cost of service revenue | — |
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| 2,118 |
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| — |
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| 4,221 |
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Selling, general and administrative | 23,451 |
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| 17,421 |
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| 47,556 |
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| 36,525 |
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Research and development | 21,488 |
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| 15,167 |
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| 39,382 |
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| 29,945 |
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Amortization of intangible assets | 6,934 |
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| 6,901 |
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| 13,880 |
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| 13,790 |
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Total operating costs and expenses | 58,479 |
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| 52,910 |
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| 114,238 |
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| 103,920 |
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Loss from operations | (34,311 | ) |
| (18,609 | ) |
| (59,576 | ) |
| (40,518 | ) |
Other income (expense): |
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Interest expense, net | (242 | ) |
| (2,131 | ) |
| (472 | ) |
| (4,182 | ) |
Change in fair value of contingent consideration related to acquisitions | (192 | ) |
| (97 | ) |
| (483 | ) |
| (294 | ) |
Other income, net | 48,492 |
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| 240 |
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| 58,463 |
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| 650 |
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Total other income (expense) | 48,058 |
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| (1,988 | ) |
| 57,508 |
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| (3,826 | ) |
Income (loss) before income taxes | 13,747 |
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| (20,597 | ) |
| (2,068 | ) |
| (44,344 | ) |
Provision for income taxes | (3 | ) |
| (255 | ) |
| (6 | ) |
| (54 | ) |
Net income (loss) | $ | 13,744 |
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| $ | (20,852 | ) |
| $ | (2,074 | ) |
| $ | (44,398 | ) |
Net income (loss) per share: |
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Basic | $ | 0.13 |
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| $ | (0.27 | ) |
| $ | (0.02 | ) |
| $ | (0.57 | ) |
Diluted (Note 7) | $ | 0.13 |
| | $ | (0.27 | ) | | $ | (0.02 | ) | | $ | (0.57 | ) |
Weighted average shares outstanding: |
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Basic | 102,597,059 |
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| 78,576,260 |
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| 101,747,416 |
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| 78,366,610 |
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Diluted | 112,617,150 |
| | 78,576,260 |
| | 101,747,416 |
| | 78,366,610 |
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See accompanying notes to these unaudited condensed consolidated financial statements.
SPECTRUM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
(Unaudited)
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| | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
Net income (loss) | $ | 13,744 |
| | $ | (20,852 | ) | | $ | (2,074 | ) | | $ | (44,398 | ) |
Other comprehensive loss: |
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Unrealized loss on available-for-sale securities, net of income tax benefit of $960, and $0 for the three and six months ended June 30, 2017 | — |
| | (2,951 | ) | | — |
| | (1,144 | ) |
Cumulative effect of ASU 2016-01 adoption on January 1, 2018 for unrealized gains on equity securities, net of income tax; recorded as a reclassification to "accumulated deficit" (see Note 3(a)) | — |
| | — |
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| (17,211 | ) |
| — |
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Foreign currency translation adjustments | (2,269 | ) | | 792 |
| | (1,876 | ) | | 944 |
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Other comprehensive loss | (2,269 | ) | | (2,159 | ) | | (19,087 | ) | | (200 | ) |
Total comprehensive income (loss) | $ | 11,475 |
| | $ | (23,011 | ) | | $ | (21,161 | ) | | $ | (44,598 | ) |
See accompanying notes to these unaudited condensed consolidated financial statements.
SPECTRUM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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| Six Months Ended June 30, |
| 2018 |
| 2017 |
Cash Flows From Operating Activities: | | | |
Net loss | $ | (2,074 | ) | | $ | (44,398 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation and amortization | 13,993 |
| | 13,961 |
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Stock-based compensation | 9,211 |
| | 7,207 |
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Accretion of debt discount on 2018 Convertible Notes, recorded to interest expense (Note 13) | 1,079 |
| | 2,794 |
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Amortization of deferred financing costs on 2018 Convertible Notes, recorded to interest expense (Note 13) | 124 |
| | 321 |
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Unrealized gains from transactions denominated in foreign currency | 10 |
| | (15 | ) |
Change in cash surrender value of corporate-owned life insurance policy | (5 | ) | | (153 | ) |
Deferred tax liabilities | 9 |
| | 127 |
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Income tax recognition on unrealized gain for available-for-sale securities | — |
| | — |
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Unrealized gains on marketable securities (Note 3(a)) | (58,634 | ) | | — |
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Change in fair value of contingent consideration related to the Talon and EVOMELA acquisitions (Note 9) | 483 |
| | 294 |
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Changes in operating assets and liabilities: | | | |
Accounts receivable, net | 5,087 |
| | (2,105 | ) |
Other receivables | (781 | ) | | 1,299 |
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Inventories | 816 |
| | 428 |
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Prepaid expenses | 1,167 |
| | (439 | ) |
Other assets | 3,451 |
| | 863 |
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Accounts payable and other accrued obligations | (8,210 | ) | | 3,519 |
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Accrued payroll and benefits | (4,314 | ) | | (2,737 | ) |
FOLOTYN development liability | (195 | ) | | (567 | ) |
Deferred revenue | — |
| | (700 | ) |
Other long-term liabilities | (464 | ) | | 847 |
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Net cash used in operating activities | (39,247 | ) |
| (19,454 | ) |
Cash Flows From Investing Activities: | | | |
Proceeds from redemption of corporate-owned life insurance policy | 4,130 |
| | — |
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Payment for corporate-owned life insurance premiums | — |
| | (601 | ) |
Redemption of mutual funds | — |
| | (1 | ) |
Purchases of property and equipment | (46 | ) | | (167 | ) |
Net cash provided by (used in) investing activities | 4,084 |
| | (769 | ) |
Cash Flows From Financing Activities: | | | |
Proceeds from employees for exercises of stock options | 4,804 |
| | 1,010 |
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Proceeds from sale of stock under employee stock purchase plan | 734 |
| | 406 |
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Proceeds from employees, for our remittance to tax authorities, related to employee vesting of restricted stock and stock option exercises | 4,645 |
| | — |
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Payments to tax authorities related to employee surrender of vested restricted stock and stock option exercises | (27,686 | ) | | (1,284 | ) |
Net cash (used in) provided by financing activities | (17,503 | ) | | 132 |
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Effect of exchange rates on cash and equivalents | (286 | ) | | 182 |
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Net decrease in cash and cash equivalents | (52,952 | ) | | (19,909 | ) |
Cash and cash equivalents—beginning of period | 227,323 |
| | 158,222 |
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Cash and cash equivalents—end of period | $ | 174,371 |
| | $ | 138,313 |
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Supplemental disclosure of cash flow information: | | | |
Cash paid for income taxes | $ | 27 |
| | $ | 10 |
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Cash paid for interest | $ | 558 |
| | $ | 1,513 |
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See accompanying notes to these unaudited condensed consolidated financial statements.
Spectrum Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
1. DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION, AND OPERATING SEGMENT
(a) Description of Business
Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharma company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. We have an in-house clinical development organization with regulatory and data management capabilities, in addition to commercial infrastructure and a field-based sales force for our marketed products. Currently, we have six approved oncology/hematology products (FUSILEV, FOLOTYN, ZEVALIN, MARQIBO, BELEODAQ, and EVOMELA) that target different types of cancer including: non-Hodgkin’s lymphoma (“NHL”), advanced metastatic colorectal cancer, acute lymphoblastic leukemia, and multiple myeloma (“MM”).
We also have three drugs in mid-to-late stage development (in Phase 2 or Phase 3 clinical trials):
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• | poziotinib, a novel pan-HER inhibitor used in the treatment of patients with a variety of solid tumors, including breast and lung cancer; |
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• | ROLONTIS for chemotherapy-induced neutropenia; and |
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• | QAPZOLA for immediate intravesical instillation in post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer (“NMIBC”). |
(b) Basis of Presentation
Interim Financial Statements
The interim financial data for the three and six months ended June 30, 2018 and 2017, respectively, is unaudited, and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three and six months ended June 30, 2018 and 2017. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the U.S. Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 (filed with the SEC on March 7, 2018).
Principles of Consolidation
The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned (except for Spectrum Pharma Canada (“SPC”), as discussed below). All inter-company accounts and transactions among these legal entities have been eliminated in consolidation.
Variable Interest Entity
We own fifty-percent of SPC, a legal entity organized in Quebec, Canada in January 2008. Some of our clinical studies are conducted through this “variable interest entity” (as defined under applicable GAAP). We fund all of SPC’s operating costs, and since we assume all risks and rewards for this entity, we meet the criteria as being its “primary beneficiary.” Accordingly, SPC’s balance sheets and statements of operations are included in our Condensed Consolidated Financial Statements as if it were a wholly-owned subsidiary for all periods presented.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
(c) Operating Segment
We operate in one reportable operating segment that is focused exclusively on developing and marketing oncology and hematology drug products. For the three and six months ended June 30, 2018 and 2017, all of our revenue and related expenses were solely attributable to these activities. Substantially all of our assets (excluding cash held in certain foreign bank accounts and ZEVALIN distribution rights for ex-U.S. territories - see Note 3(f)) are held in the United States.
2. USE OF ESTIMATES AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses. These amounts may materially differ from the amount ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. On an on-going basis, our management evaluates its most critical estimates and assumptions, including those related to (i) gross-to-net revenue adjustments; (ii) the timing of revenue recognition; (iii) the collectability of customer accounts; (iv) whether the cost of our inventories can be recovered; (v) the recoverability of our reported goodwill and intangible assets; (vi) the realization of our tax assets and estimates of our tax liabilities; (vii) the likelihood of payment and value of contingent liabilities; (viii) the fair value of our investments; (ix) the valuation of our stock options and the periodic expense recognition of stock-based compensation; and (x) the potential outcome of our ongoing or threatened litigation.
Our accounting policies and estimates that most significantly impact the presented amounts within our Condensed Consolidated Financial Statements are further described below:
(i) Revenue Recognition
Impact of the New Revenue Recognition Standard: ASU No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), became effective for us on January 1, 2018. Our disclosure within the below sections to this footnote reflects our updated accounting policies that are affected by this new standard. We applied the “modified retrospective” transition method for open contracts for the implementation of Topic 606; this resulted in the recognition of an aggregate $4.7 million, net of tax, decrease to our January 1, 2018 “accumulated deficit” on our accompanying Condensed Consolidated Balance Sheets for the cumulative impact of applying this new standard. We made no adjustments to our previously-reported total revenues, as those periods continue to be presented in accordance with our historical accounting practices under Topic 605, Revenue Recognition. See Notes 4, 5, and 19 for additional quantitative and qualitative revenue disclosures in accordance with Topic 606.
Required Elements of Our Revenue Recognition: Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Topic 606 in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements:
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(1) | we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable; |
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(2) | we identify the “performance obligations” in the respective contract; |
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(3) | we determine the “transaction price” for each performance obligation in the respective contract; |
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(4) | we allocate the transaction price to each performance obligation; and |
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(5) | we recognize revenue only when we satisfy each performance obligation. |
These five elements, as applied to each of our revenue categories, are summarized below:
(a) Product Sales: We sell our products to pharmaceutical wholesalers/distributors (i.e., our customers), except for our U.S. sales of ZEVALIN in which case the end-user (i.e., clinic or hospital) is our customer. Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration.
Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in our reported “product sales, net” in the accompanying Condensed Consolidated Statements of Operations, reflecting the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and GPO administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales.
These GTN estimate categories are each discussed below:
Product Returns Allowances: Our FUSILEV, MARQIBO, and BELEODAQ customers are contractually permitted to return purchased products beginning at its expiration date and within six months thereafter. Our EVOMELA customers are permitted to return purchased product beginning at six months prior to its expiration date, and within 12 months thereafter (as well as for overstock inventory, as determined by end-users). ZEVALIN and FOLOTYN returns for expiry are not contractually permitted. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns for our allowance based on our historical return rates. Returned product is typically destroyed, since substantially all returns are due to expiry and cannot be resold.
Government Chargebacks: Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers.
Prompt Pay Discounts: Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage.
Commercial Rebates: Commercial rebates are based on (i) our estimates of end-user purchases through a group purchasing organization (“GPO”), (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us.
Medicaid Rebates: Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in us receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment.
Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products (except for U.S. sales of ZEVALIN) for various commercial services including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales.
(b) License Fees: Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows:
(1) Upfront license fees: We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer).
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
(2) Royalties: Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our
licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt.
(3) Sales milestones: Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt.
(4) Regulatory milestones: Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee.
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• | When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. |
| |
• | When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment. |
(c) Service Revenue: We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services.
Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events.
We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition.
(ii) Cash and Cash Equivalents
Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
(iii) Marketable Securities
Our marketable securities consist of our holdings in equity securities (beginning January 1, 2018 - see Note 3(a)), mutual funds, and bank certificates of deposit (“Bank CDs”). Beginning January 1, 2018, our realized and unrealized gains (losses) on marketable securities are included in “Other income, net” on the accompanying Condensed Consolidated Statements of Operations. Prior to January 1, 2018, our unrealized gains (losses) were included in “other comprehensive (loss) income” on our accompanying Condensed Consolidated Statements of Comprehensive Loss.
(iv) Accounts Receivable
Our accounts receivables are derived from our product sales and license fees (our service revenue is recorded in “other receivables”), and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in our existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted.
(v) Inventories
We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast by product and corresponding expiry dates of each product lot.
Manufacturing costs of drug products that are pending U.S. Food and Drug Administration (“FDA”) approval are expensed through “research and development,” on the accompanying Condensed Consolidated Statements of Operations (rather than being capitalized to “inventories”).
(vi) Property and Equipment
Our property and equipment is stated at historical cost, and is depreciated on a straight-line basis over an estimated useful life that corresponds with its designated asset category. We evaluate the recoverability of “long-lived assets” (which includes property and equipment) whenever events or changes in circumstances in our business indicate that the asset’s carrying amount may not be recoverable through our on-going operations.
(vii) Goodwill and Intangible Assets
Our goodwill represents the excess of our business acquisition cost over the estimated fair value of the net assets acquired in the corresponding transaction. Goodwill has an indefinite accounting life and is therefore not amortized. Instead, goodwill is evaluated for impairment on an annual basis (as of each October 1st), unless we identify impairment indicators that would require earlier testing.
We evaluate the recoverability of indefinite-lived intangible assets at least annually, or whenever events or changes in our business indicate that an intangible asset’s (whether indefinite or definite-lived) carrying amount may not be recoverable. Such circumstances could include, but are not limited to the following:
| |
(a) | a significant decrease in the market value of an asset; |
| |
(b) | a significant adverse change in the extent or manner in which an asset is used; or |
| |
(c) | an accumulation of costs significantly in excess of the amount originally expected for the acquisition of an asset. |
Intangible assets with finite useful lives are amortized over their estimated useful lives on a straight-line basis. We review these assets for potential impairment if/when facts or circumstances suggest that the carrying value of these assets may not be recoverable.
(viii) Stock-Based Compensation
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting.
The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term.
With regard to (a)-(d): We estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option.
(ix) Foreign Currency Translation
We translate the assets and liabilities of our foreign subsidiaries that are stated in their functional currencies (i.e., local operating currencies), to U.S. dollars at the rates of exchange in effect at the reported balance sheet date. Revenues and expenses are translated using the monthly average exchange rates during the reported period. Unrealized gains and losses from the translation of our subsidiaries’ financial statements (that are initially denominated in the corresponding functional currency) are included as a separate component of “accumulated other comprehensive (loss) income” in the Condensed Consolidated Balance Sheets.
We record foreign currency transactions, when initially denominated in a currency other than the respective functional currency of our subsidiary, at the prevailing exchange rate on the date of the transaction. Resulting unrealized foreign exchange gains and losses from transactions with third parties are included in “accumulated other comprehensive (loss) income” in the Condensed Consolidated Balance Sheets.
All unrealized foreign exchange gains and losses associated with our intercompany loans are included in “accumulated other comprehensive (loss) income” in the Condensed Consolidated Balance Sheets, as these loans with our foreign subsidiaries are not expected to be settled in the “foreseeable future.”
(x) Basic and Diluted Net Loss per Share
We calculate basic and diluted net loss per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period.
(xi) Income Taxes
Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain.
We have recorded a valuation allowance to reduce our deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “provision for income taxes” within the Condensed Consolidated Statements of Operations for the period in which we received the notice.
(xii) Research and Development Costs
Our research and development costs are expensed as incurred, or as certain milestone payments become due, which are generally triggered by contractual clinical or regulatory events.
(xiii) Fair Value Measurements
We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date.
Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public.
Level 3: Unobservable inputs are used when little or no market data is available.
3. BALANCE SHEET ACCOUNT DETAIL
The composition of selected financial statement captions that comprise the accompanying Condensed Consolidated Balance Sheets are summarized below:
(a) Cash and Cash Equivalents and Marketable Securities
As of June 30, 2018 and December 31, 2017, our “cash and cash equivalents” were held with major financial institutions. Our “marketable securities” solely relate to our equity holdings in CASI (see Note 10).
We maintain cash balances in excess of federally insured limits with reputable financial institutions. To a limited degree, the Federal Deposit Insurance Corporation (“FDIC”) and other third parties insure these investments. However, these investments are not insured against the possibility of a complete loss of earnings or principal and are inherently subject to the credit risk related to the continued credit worthiness of the underlying issuer and general credit market risks. We manage such risks in our portfolio by investing in highly liquid, highly-rated instruments, and limit investing in long-term maturity instruments.
Our investment policy requires that purchased investments in marketable securities may only be in highly-rated instruments, which are primarily U.S. treasury bills or treasury-backed securities, and also limits our investments in securities of any single issuer (excluding any debt or equity securities received from our strategic partners in connection with an out-license arrangement, as discussed in Note 10).
The carrying amount of our equity securities, money market funds, and Bank CDs approximates their fair value (utilizing “Level 1” or “Level 2” inputs – see Note 2(xiii)) because of our ability to immediately convert these instruments into cash with minimal expected change in value.
The following is a summary of our presented “cash and cash equivalents” and “marketable securities”:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | |
| Cost | | Foreign Currency Translation | | Gross Unrealized Gains* | | Gross Unrealized Losses | | Estimated Fair Value | | Cash and Cash Equivalents | | Marketable Securities |
June 30, 2018 | | |
| | | | | | | | | | |
Equity securities* (see Note 3(g) and Note 10) | $ | 8,710 |
| | $ | (1,747 | ) | | $ | 88,075 |
| | $ | — |
| | $ | 95,038 |
| | $ | — |
| | $ | 95,038 |
|
Bank deposits | 10,769 |
| | — |
| | — |
| | — |
| | 10,769 |
| | 10,769 |
| | — |
|
Money market funds | 163,602 |
| | — |
| | — |
| | — |
| | 163,602 |
| | 163,602 |
| | — |
|
Bank certificates of deposits | 249 |
| | — |
| | — |
| | — |
| | 249 |
| | — |
| | 249 |
|
Total cash and cash equivalents and marketable securities | $ | 183,330 |
| | $ | (1,747 | ) | | $ | 88,075 |
| | $ | — |
| | $ | 269,658 |
| | $ | 174,371 |
| | $ | 95,287 |
|
December 31, 2017 | | |
| | | | | | | | | | |
Bank deposits | $ | 10,965 |
| | $ | — |
| | $ | — |
| | $ | — |
| | $ | 10,965 |
| | $ | 10,965 |
| | $ | — |
|
Money market funds | 216,358 |
| | — |
| | — |
| | — |
| | 216,358 |
| | 216,358 |
| | — |
|
Bank certificates of deposits | 248 |
| | — |
| | — |
| | — |
| | 248 |
| | — |
| | 248 |
|
Total cash and cash equivalents and marketable securities | $ | 227,571 |
| | $ | — |
| | $ | — |
| | $ | — |
| | $ | 227,571 |
| | $ | 227,323 |
| | $ | 248 |
|
* Beginning January 1, 2018, under the new requirements of ASU 2016-01, Recognition and Measurement of Financial Assets and Liabilities, the unrealized gains (losses) on our CASI Pharmaceuticals, Inc. (NASDAQ: CASI) (“CASI”) equity securities are recognized as an increase (decrease) to “other income, net” on the Consolidated Statements of Operations (rather than through “other comprehensive (loss) income” on the Consolidated Statements of Comprehensive Loss). Our adoption of ASU 2016-01 on January 1, 2018, resulted in a $17.2 million cumulative-effect adjustment, net of income tax, recorded as a decrease to “accumulated other comprehensive (loss) income” and a decrease to “accumulated deficit” on the accompanying Condensed Consolidated Balance Sheets. Our recognized unrealized gain on these equity securities for the three and six months ended June 30, 2018 was $48.5 million and $58.6 million, respectively, as reported in “other income, net” on the accompanying Condensed Consolidated Statements of Operations.
As of June 30, 2018, none of our securities were in an unrealized loss position.
(b) Property and Equipment, net of Accumulated Depreciation
“Property and equipment, net of accumulated depreciation” consists of the following:
|
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Computer hardware and software | $ | 3,080 |
| | $ | 2,994 |
|
Laboratory equipment | 635 |
| | 630 |
|
Office furniture | 212 |
| | 218 |
|
Leasehold improvements | 2,938 |
| | 2,938 |
|
Property and equipment, at cost | 6,865 |
| | 6,780 |
|
(Less): Accumulated depreciation | (6,342 | ) | | (6,191 | ) |
Property and equipment, net of accumulated depreciation | $ | 523 |
| | $ | 589 |
|
Depreciation expense (included within “total operating costs and expenses” in the accompanying Condensed Consolidated Statements of Operations) for the six months ended June 30, 2018 and 2017, was $112 thousand and $0.2 million, respectively.
In February 2016, the FASB issued ASU 2016-02, which amends the FASB Accounting Standards Codification and creates Topic 842, Leases. The new topic supersedes Topic 840, Leases, and requires lease assets and lease liabilities (including those for operating leases) to be presented on the balance sheet at their “gross amounts” and requires additional disclosures regarding lease arrangements. Topic 842 is effective for us beginning January 1, 2019, and mandates a “modified retrospective” transition method. We are currently assessing the quantitative impact this guidance will have on our consolidated financial statements. We presently do not have any capital lease arrangements, or have any active contracts that would contain an “embedded lease”. Our current lease arrangements affected by this “gross-up” presentation on our balance sheets, beginning
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
January 1, 2019, are limited to our principal executive office in Henderson, Nevada, and our administrative and research and development facility in Irvine, California, in addition to several other administrative office leases.
(c) Inventories
“Inventories” consists of the following:
|
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Raw materials | $ | 2,149 |
| | $ | 1,077 |
|
Work-in-process | 3,204 |
| | 2,551 |
|
Finished goods | 2,647 |
| | 5,187 |
|
(Less:) Non-current portion of inventories included within "other assets" * | (3,480 | ) | | (3,100 | ) |
Inventories | $ | 4,520 |
| | $ | 5,715 |
|
* The “non-current” portion of inventories is presented within “other assets” in the accompanying Condensed Consolidated Balance Sheets at June 30, 2018 and December 31, 2017, respectively. This value of $3.5 million at June 30, 2018 represents product that we expect to sell beyond June 30, 2019 and the value at December 31, 2017 represents product that we expect to sell beyond December 31, 2018.
.
(d) Prepaid Expenses and Other Assets
“Prepaid expenses and other assets” consists of the following:
|
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Other miscellaneous prepaid operating expenses | $ | 3,900 |
| | $ | 3,389 |
|
Prepaid insurance | 761 |
| | 645 |
|
Research and development supplies | 108 |
| | 1,883 |
|
Key employee life insurance - cash surrender value | — |
| | 4,150 |
|
Prepaid expenses and other assets | $ | 4,769 |
| | $ | 10,067 |
|
(e) Other Receivables
“Other receivables” consists of the following:
|
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Other miscellaneous receivables* | $ | 968 |
| | $ | 1,152 |
|
Income tax receivable | 638 |
| | 665 |
|
Insurance receivable | 1,130 |
| | 53 |
|
Reimbursements due from development partners for incurred research and development expenses | 179 |
| | 263 |
|
Other receivables | $ | 2,915 |
| | $ | 2,133 |
|
* As of June 30, 2018 and December 31, 2017, the balance is inclusive of $0.4 million and $0.4 million, respectively, of Medicaid rebate credits to be applied against future invoices for each respective state program, and $0.2 million and $0.4 million, respectively, of royalty receivables from Mundipharma International Corporation Limited (“Mundipharma”) for sales of ZEVALIN in Japan.
(f) Intangible Assets and Goodwill
Intangible assets, net of accumulated amortization and impairment charges consists of the following:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | | | | | | | | | | | | | | | | | | | | | |
| | | June 30, 2018 |
| Historical Cost | | Accumulated Amortization | | Foreign Currency Translation | | Impairment | | Net Amount | | Full Amortization Period (months) | | Remaining Amortization Period (months) |
MARQIBO IPR&D (NHL and other novel indications) | $ | 17,600 |
| | $ | — |
| | $ | — |
| | $ | — |
| | $ | 17,600 |
| | n/a | | n/a |
EVOMELA distribution rights | 7,700 |
| | (1,333 | ) | | — |
| | — |
| | 6,367 |
| | 156 | | 129 |
BELEODAQ distribution rights | 25,000 |
| | (7,500 | ) | | — |
| | — |
| | 17,500 |
| | 160 | | 112 |
MARQIBO distribution rights | 26,900 |
| | (19,342 | ) | | — |
| | — |
| | 7,558 |
| | 81 | | 21 |
FOLOTYN distribution rights (1) | 118,400 |
| | (60,649 | ) | | — |
| | — |
| | 57,751 |
| | 152 | | 53 |
ZEVALIN distribution rights – U.S. | 41,900 |
| | (39,294 | ) | | — |
| | — |
| | 2,606 |
| | 123 | | 9 |
ZEVALIN distribution rights – ex-U.S. | 23,490 |
| | (17,624 | ) | | (2,994 | ) | | — |
| | 2,872 |
| | 96 | | 21 |
FUSILEV distribution rights (2) | 16,778 |
| | (9,618 | ) | | — |
| | (7,160 | ) | | — |
| | 56 | | 0 |
FOLOTYN out-license (3) | 27,900 |
| | (15,917 | ) | | — |
| | (1,023 | ) | | 10,960 |
| | 110 | | 49 |
Total intangible assets | $ | 305,668 |
| | $ | (171,277 | ) | | $ | (2,994 | ) | | $ | (8,183 | ) | | $ | 123,214 |
| | | | |
| |
(1) | Beginning June 2016, we adjusted the amortization period of our FOLOTYN distribution rights to November 2022 from March 2025, representing the period through which we expect to have patent protection from generic competition (see Note 16(g)). |
| |
(2) | On February 20, 2015, the United States District Court for the District of Nevada found the patent covering FUSILEV to be invalid, which was upheld on appeal. On April 24, 2015, Sandoz began to commercialize a generic version of FUSILEV. This represented a “triggering event” under applicable GAAP in evaluating the value of our FUSILEV distribution rights as of March 31, 2015, resulting in a $7.2 million impairment charge (non-cash) in the first quarter of 2015. We accelerated amortization expense recognition in 2015 for the then remaining net book value of FUSILEV distribution rights. |
| |
(3) | On May 29, 2013, we amended our FOLOTYN collaboration agreement with Mundipharma. As a result of the amendment, Europe and Turkey were excluded from Mundipharma’s commercialization territory, and their royalty rates and milestone payments to us were modified. This constituted a change under which we originally valued the FOLOTYN out-license as part of business combination accounting, resulting in an impairment charge (non-cash) of $1.0 million in the second quarter of 2013. |
|
| | | | | | | | | | | | | | | | | | | |
| | | December 31, 2017 |
| Historical Cost | | Accumulated Amortization | | Foreign Currency Translation | | Impairment | | Net Amount |
MARQIBO IPR&D (NHL and other novel indications) | $ | 17,600 |
| | $ | — |
| | $ | — |
| | $ | — |
| | $ | 17,600 |
|
EVOMELA distribution rights | 7,700 |
| | (1,037 | ) | | — |
| | — |
| | 6,663 |
|
BELEODAQ distribution rights | 25,000 |
| | (6,563 | ) | | — |
| | — |
| | 18,437 |
|
MARQIBO distribution rights | 26,900 |
| | (17,182 | ) | | — |
| | — |
| | 9,718 |
|
FOLOTYN distribution rights | 118,400 |
| | (54,111 | ) | | — |
| | — |
| | 64,289 |
|
ZEVALIN distribution rights – U.S. | 41,900 |
| | (37,557 | ) | | — |
| | — |
| | 4,343 |
|
ZEVALIN distribution rights – Ex-U.S. | 23,490 |
| | (17,232 | ) | | (2,471 | ) | | — |
| | 3,787 |
|
FUSILEV distribution rights | 16,778 |
| | (9,618 | ) | | — |
| | (7,160 | ) | | — |
|
FOLOTYN out-license | 27,900 |
| | (14,555 | ) | | — |
| | (1,023 | ) | | 12,322 |
|
Total intangible assets | $ | 305,668 |
| | $ | (157,855 | ) | | $ | (2,471 | ) | | $ | (8,183 | ) | | $ | 137,159 |
|
Intangible asset amortization expense recognized during the six months ended June 30, 2018 and 2017, was $13.9 million and $13.8 million, respectively.
Estimated intangible asset amortization expense for the remainder of 2018 and the five succeeding fiscal years and thereafter is as follows:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | |
Years Ending December 31, | |
Remainder of 2018 | $ | 13,850 |
|
2019 | 25,095 |
|
2020 | 19,756 |
|
2021 | 18,266 |
|
2022 | 15,882 |
|
2023 | 2,467 |
|
2024 and thereafter | 10,298 |
|
| $ | 105,614 |
|
“Goodwill” consists of the following:
|
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Acquisition of Talon (MARQIBO rights) | $ | 10,526 |
| | $ | 10,526 |
|
Acquisition of ZEVALIN Ex-U.S. distribution rights | 2,525 |
| | 2,525 |
|
Acquisition of Allos (FOLOTYN rights) | 5,346 |
| | 5,346 |
|
Foreign currency exchange translation effects | (291 | ) | | (235 | ) |
Goodwill | $ | 18,106 |
| | $ | 18,162 |
|
(g) Other Assets
“Other assets” consists of the following:
|
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Equity securities (see Note 10)* | $ | — |
| | $ | 37,530 |
|
Key employee life insurance – cash surrender value | 6,123 |
| | 10,737 |
|
Inventories - non-current portion | 3,480 |
| | 3,100 |
|
Promissory note receivable - long term (see Note 10) | 1,521 |
| | 1,517 |
|
Income tax receivable** | 668 |
| | 668 |
|
Research & development supplies and other | 1,367 |
| | 231 |
|
Other assets | $ | 13,159 |
| | $ | 53,783 |
|
* As of March 31, 2018, we reclassified our presentation of these equity securities from this account caption to “marketable securities” on the face of our accompanying Condensed Consolidated Balance Sheets - see Note 3(a).
** This value represents the non-current portion of the refundable alternative minimum tax credit that is expected to be received over the next few years (see Note 16).
(h) Accounts Payable and Other Accrued Liabilities
“Accounts payable and other accrued liabilities” consists of the following: |
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Trade accounts payable and other accrued liabilities | $ | 29,370 |
| | $ | 33,648 |
|
Accrued rebates | 6,904 |
| | 7,990 |
|
Accrued product royalty | 3,427 |
| | 4,339 |
|
Allowance for returns | 4,378 |
| | 4,045 |
|
Accrued data and distribution fees | 3,036 |
| | 4,305 |
|
Accrued GPO administrative fees | 230 |
| | 296 |
|
Accrued inventory management fee | 799 |
| | 1,126 |
|
Allowance for chargebacks | 1,742 |
| | 2,368 |
|
Accounts payable and other accrued liabilities | $ | 49,886 |
| | $ | 58,117 |
|
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of GTN estimates (see Note 2(i)) were as follows: |
| | | | | | | | | | | |
| Commercial/Medicaid Rebates and Government Chargebacks | | Distribution, Data, Inventory and GPO Administrative Fees | | Product Return Allowances |
Balance as of December 31, 2016 | $ | 9,817 |
| | $ | 5,146 |
| | $ | 2,309 |
|
Add: provisions | 106,647 |
| | 20,104 |
| | 2,807 |
|
(Less): credits or actual allowances | (106,106 | ) | | (19,523 | ) | | (1,071 | ) |
Balance as of December 31, 2017 | 10,358 |
| | 5,727 |
| | 4,045 |
|
Add: provisions | 33,083 |
| | 7,094 |
| | 898 |
|
(Less): credits or actual allowances | (34,795 | ) | | (8,756 | ) | | (565 | ) |
Balance as of June 30, 2018 | $ | 8,646 |
| | $ | 4,065 |
| | $ | 4,378 |
|
(i) Deferred Revenue
Deferred revenue (current and non-current) consists of the following: |
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
EVOMELA deferred revenue | $ | — |
| | $ | 3,819 |
|
ZEVALIN out-license in India territory (see Note 15(b)(iii)) | — |
| | 368 |
|
Deferred revenue* | $ | — |
| | $ | 4,187 |
|
* On January 1, 2018, we reclassified the deferred revenue related to our EVOMELA product sales and our ZEVALIN out-license in the India territory of $3.8 million and $0.4 million, respectively. These amounts were included in the $4.7 million aggregate decrease to “accumulated deficit” on January 1, 2018, in accordance with the adoption of Topic 606 (see Note 2(i)).
(j) Other Long-Term Liabilities
“Other long-term liabilities” consists of the following: |
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Accrued executive deferred compensation | $ | 5,212 |
| | $ | 5,928 |
|
Deferred rent (non-current portion) | 1 |
| | 52 |
|
Clinical study holdback fees, non-current | 62 |
| | 59 |
|
Other tax liabilities | 176 |
| | 176 |
|
Royalty liability | 300 |
| | — |
|
Other long-term liabilities | $ | 5,751 |
| | $ | 6,215 |
|
4. GROSS-TO-NET PRODUCT SALES
The below table presents a GTN (see Note 2(i)) product sales reconciliation for the accompanying Condensed Consolidated Statements of Operations:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
Gross product sales | $ | 44,062 |
| | $ | 67,709 |
| | $ | 93,651 |
| | $ | 125,926 |
|
Commercial rebates and government chargebacks | (16,053 | ) | | (30,001 | ) | | (33,083 | ) | | (57,324 | ) |
Data and distribution fees, GPO fees, and inventory management fees | (3,584 | ) | | (5,176 | ) | | (7,094 | ) | | (9,640 | ) |
Prompt pay discounts | (323 | ) | | (419 | ) | | (713 | ) | | (688 | ) |
Product returns | (349 | ) | | (957 | ) | | (898 | ) | | (1,273 | ) |
Product sales, net | $ | 23,753 |
| | $ | 31,156 |
| | $ | 51,863 |
| | $ | 57,001 |
|
5. COMPOSITION OF TOTAL REVENUE
The below table presents our net product sales by geography for the three and six months ended June 30, 2018 and 2017:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
United States | $ | 21,347 |
| | 89.9 | % | | $ | 29,064 |
| | 93.3 | % | | $ | 44,545 |
| | 85.9 | % | | $ | 52,865 |
| | 92.7 | % |
International: | | | | | | | | |
|
| |
|
| |
|
| |
|
|
Europe/Canada | 2,406 |
| | 10.1 | % | | 2,092 |
| | 6.7 | % | | 5,894 |
| | 11.4 | % | | 4,136 |
| | 7.3 | % |
Asia Pacific | — |
| | — | % | | — |
| | — | % | | 1,424 |
| | 2.7 | % | | — |
| | — | % |
Total International | 2,406 |
| | 10.1 | % | | 2,092 |
| | 6.7 | % | | 7,318 |
| | 14.1 | % | | 4,136 |
| | 7.3 | % |
Product sales, net | $ | 23,753 |
| | 100.0 | % | | $ | 31,156 |
| | 100.0 | % | | $ | 51,863 |
| | 100.0 | % | | $ | 57,001 |
| | 100.0 | % |
The below table presents our net sales by product for the three and six months ended June 30, 2018 and 2017:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
FOLOTYN | $ | 11,680 |
| | 49.2 | % | | $ | 11,181 |
| | 35.9 | % | | $ | 24,402 |
| | 47.1 | % | | $ | 20,455 |
| | 35.9 | % |
EVOMELA | 5,779 |
| | 24.3 | % | | 10,058 |
| | 32.3 | % | | 13,913 |
| | 26.8 | % | | 16,359 |
| | 28.7 | % |
BELEODAQ | 2,703 |
| | 11.4 | % | | 3,396 |
| | 10.9 | % | | 5,416 |
| | 10.4 | % | | 6,267 |
| | 11.0 | % |
ZEVALIN | 1,638 |
| | 6.9 | % | | 2,297 |
| | 7.4 | % | | 4,661 |
| | 9.0 | % | | 5,144 |
| | 9.0 | % |
MARQIBO | 1,149 |
| | 4.8 | % | | 2,163 |
| | 6.9 | % | | 2,043 |
| | 3.9 | % | | 4,142 |
| | 7.3 | % |
FUSILEV | 804 |
| | 3.4 | % | | 2,061 |
| | 6.6 | % | | 1,428 |
| | 2.8 | % | | 4,634 |
| | 8.1 | % |
Product sales, net | $ | 23,753 |
| | 100.0 | % | | $ | 31,156 |
| | 100.0 | % | | $ | 51,863 |
| | 100.0 | % | | $ | 57,001 |
| | 100.0 | % |
The below table presents our license fees and service revenue by source for the three and six months ended June 30, 2018 and 2017:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
Out-license of FOLOTYN in all countries except the United States, Canada, Europe, and Turkey: royalties (Note 14) | $ | 415 |
| | 100.0 | % | | $ | 119 |
| | 3.8 | % |
| 792 |
|
| 28.3 | % |
| 382 |
|
| 6.0 | % |
Out-license of ZEVALIN: recognition of milestone achievement, upfront cash receipt and subsequent royalties for Asia and certain other territories, excluding China (Note 11) | — |
| | — | % | | 630 |
| | 20.0 | % |
| 2,001 |
|
| 71.5 | % |
| 1,245 |
|
| 19.5 | % |
Out-license of ZEVALIN: amortization of upfront cash receipt related to India territory (Note 15(b)(iii)) and other | — |
| | — | % | | 12 |
| | 0.4 | % |
| 6 |
|
| 0.2 | % |
| 24 |
|
| 0.4 | % |
Out-license of ZEVALIN, FOLOTYN, BELEODAQ, MARQIBO: upfront cash receipt and subsequent royalties for the Canada territory (Note 15(b)(xiv)) | — |
| | — | % | | 3 |
| | 0.1 | % |
| — |
|
| — | % |
| 3 |
|
| — | % |
Sales and marketing contracted services (Note 12) | — |
| | — | % | | 2,381 |
| | 75.7 | % |
|
|
|
| — | % |
| 4,747 |
|
| 74.2 | % |
License fees and service revenues | $ | 415 |
| | 100.0 | % | | $ | 3,145 |
| | 100.0 | % |
| $ | 2,799 |
|
| 100.0 | % |
| $ | 6,401 |
|
| 100.0 | % |
6. STOCK-BASED COMPENSATION
We report our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) contribution matching program) in the accompanying Condensed Consolidated Statements of Operations, based on the assigned department of the recipient. Stock-based compensation expense included within “total operating costs and expenses” for the three and six months ended June 30, 2018 and 2017, was as follows (see Note 18 for a discussion of certain immaterial corrections affecting the presented 2017 amounts below):
|
| | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
Cost of sales | $ | 80 |
| | $ | 51 |
| | $ | 146 |
| | $ | 81 |
|
Selling, general and administrative | 3,832 |
| | 2,888 |
| | 7,522 |
| | 6,126 |
|
Research and development | 822 |
| | 548 |
| | 1,543 |
| | 1,000 |
|
Total stock-based compensation | $ | 4,734 |
| | $ | 3,487 |
| | $ | 9,211 |
| | $ | 7,207 |
|
7. NET INCOME (LOSS) PER SHARE
Net income (loss) per share was computed by dividing net loss by the weighted average number of common shares outstanding for the three and six months ended June 30, 2018 and 2017:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
Basic weighted average shares outstanding | 102,597,059 |
| | 78,576,260 |
| | 101,747,416 |
| | 78,366,610 |
|
Effect of dilutive securities: |
|
| |
|
| |
|
| |
|
|
2018 Convertible Notes | 3,854,959 |
| | — |
| | — |
| | — |
|
Common stock options | 3,870,462 |
| | — |
| | — |
| | — |
|
Restricted stock awards | 1,797,089 |
| | — |
| | — |
| | — |
|
Restricted stock units | 245,214 |
| | — |
| | — |
| | — |
|
Common stock warrants | 252,368 |
| | — |
| | — |
| | — |
|
Diluted average shares outstanding | 112,617,151 |
| | 78,576,260 |
| | 101,747,416 |
| | 78,366,610 |
|
Net income (loss) as reported | $ | 13,744 |
| | $ | (20,852 | ) | | $ | (2,074 | ) | | $ | (44,398 | ) |
Interest attributable to 2018 Convertible Notes | 886 |
| | — |
| | — |
| | — |
|
Net income (loss) for diluted earnings per share | $ | 14,630 |
| | $ | (20,852 | ) | | $ | (2,074 | ) | | $ | (44,398 | ) |
Net income (loss) per share – basic | $ | 0.13 |
| | $ | (0.27 | ) | | $ | (0.02 | ) | | $ | (0.57 | ) |
Net income (loss) per share – diluted | $ | 0.13 |
| | $ | (0.27 | ) | | $ | (0.02 | ) | | $ | (0.57 | ) |
The below outstanding securities for the six months ended June 30, 2018 and three and six months ended June 30, 2017 were excluded from the calculation above because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive due to our net loss per share in each respective period, as summarized below:
|
| | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
2018 Convertible Notes | — |
| | 10,454,799 |
|
| 3,854,959 |
|
| 10,454,799 |
|
Common stock options | — |
| | 1,271,207 |
|
| 4,396,587 |
|
| 1,110,474 |
|
Restricted stock awards | — |
| | 2,166,299 |
|
| 1,797,089 |
|
| 2,166,299 |
|
Restricted stock units | — |
| | 217,206 |
|
| 245,214 |
|
| 217,206 |
|
Common stock warrants | — |
| | 13,337 |
|
| 257,039 |
|
| 1,813 |
|
Total | — |
| | 14,122,848 |
| | 10,550,888 |
| | 13,950,591 |
|
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
8. FAIR VALUE MEASUREMENTS
The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among three fair value measurement categories (see Note 2(xiii)): |
| | | | | | | | | | | | | | | | |
| June 30, 2018 Fair Value Measurements | |
| Level 1 | | Level 2 | | Level 3 | | Total | |
Assets: |
| |
| |
| |
| |
Bank certificates of deposits | $ | — |
| | $ | 249 |
| | $ | — |
| | $ | 249 |
| |
Money market funds | — |
| | 163,602 |
| | — |
| | 163,602 |
| |
Equity securities (Note 3(a)) | 95,038 |
| | — |
| | — |
| | 95,038 |
| |
Mutual funds | — |
| | 101 |
| | — |
| | 101 |
| |
Deferred compensation investments (life insurance cash surrender value - Note 3(g)) | — |
| | 6,123 |
| | — |
| | 6,123 |
| * |
| $ | 95,038 |
| | $ | 170,075 |
| | $ | — |
| | $ | 265,113 |
| |
Liabilities: |
| |
| |
| |
| |
Deferred executive compensation liability (Note 15(f)) | $ | — |
| | $ | 5,973 |
| | $ | — |
| | $ | 5,973 |
| * |
Drug development liability (Note 14) | — |
| | — |
| | 12,191 |
| | 12,191 |
| |
Talon CVR (Note 9(a)) | — |
| | — |
| | 6,693 |
| | 6,693 |
| |
Corixa Liability (Note 15(b)(i)) | — |
| | — |
| | 62 |
| | 62 |
| |
| $ | — |
| | $ | 5,973 |
| | $ | 18,946 |
| | $ | 24,919 |
| |
|
| | | | | | | | | | | | | | | | |
| December 31, 2017 Fair Value Measurements | |
| Level 1 | | Level 2 | | Level 3 | | Total | |
Assets: |
| |
| |
| |
| |
Bank certificates of deposits | $ | — |
| | $ | 248 |
| | $ | — |
| | $ | 248 |
| |
Money market funds | — |
| | 216,358 |
| | — |
| | 216,358 |
| |
Equity securities (Note 10) | 37,530 |
| | — |
| | — |
| | 37,530 |
| |
Mutual funds | — |
| | 59 |
| | — |
| | 59 |
| |
Deferred compensation investments (life insurance cash surrender value) | — |
| | 14,887 |
| | — |
| | 14,887 |
| * |
| $ | 37,530 |
| | $ | 231,552 |
| | $ | — |
| | $ | 269,082 |
| |
Liabilities: |
| |
| |
| |
| |
Deferred executive compensation liability (Note 15(f)) | $ | — |
| | $ | 11,038 |
| | $ | — |
| | $ | 11,038 |
| * |
Drug development liability (Note 14) | — |
| | — |
| | 12,386 |
| | 12,386 |
| |
Talon CVR (Note 9(a)) | — |
| | — |
| | 6,210 |
| | 6,210 |
| |
Corixa Liability (Note 15(b)(i)) | — |
| | — |
| | 62 |
| | 62 |
| |
| $ | — |
| | $ | 11,038 |
| | $ | 18,658 |
| | $ | 29,696 |
| |
* The reported amount of “deferred compensation investments” is based on the cash surrender value of (ex)employee life insurance policies at period-end, while the reported amount of “deferred executive compensation liability” is based on the period-end market value of investments selected by plan participants.
We did not have any transfers between “Level 1” and “Level 2” (see Note 2(xiii)) for all periods presented.
The table below summarizes the 2017 and 2018 activity of our liabilities that are valued with unobservable inputs:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | |
| Fair Value Measurements of Unobservable Inputs (Level 3) |
Balance as of December 31, 2016 | $ | 14,445 |
|
FOLOTYN development liability (see Note 14) | (744 | ) |
Talon CVR fair value adjustment - MARQIBO (see Note 9(a)) | 4,957 |
|
Balance as of December 31, 2017 | 18,658 |
|
FOLOTYN development liability (see Note 14) | (195 | ) |
Talon CVR fair value adjustment - MARQIBO (see Note 9(a)) | 483 |
|
Balance as of June 30, 2018 | $ | 18,946 |
|
* This amount is comprised of the current and non-current portions of “FOLOTYN development liability” and the non-current portion of “acquisition-related contingent obligations” on our accompanying Condensed Consolidated Balance Sheets.
Our carrying amounts of financial instruments such as cash equivalents, accounts receivable, prepaid expenses, accounts payable, and accrued liabilities, excluding acquisition-related contingent obligations, approximate their related fair values due to their short-term nature.
9. BUSINESS COMBINATIONS AND CONTINGENT CONSIDERATION
(a) Acquisition of Talon Therapeutics, Inc.
Overview of Talon Acquisition
On July 17, 2013, we purchased all of the outstanding shares of common stock of Talon Therapeutics, Inc. (“Talon”). Through the acquisition of Talon, we gained worldwide rights to MARQIBO. The Talon purchase consideration consisted of (i) an aggregate upfront cash amount of $11.3 million, (ii) issuance of 3.0 million shares of our common stock, then equivalent to $26.3 million (based on a closing price of $8.77 per share on July 17, 2013), and (iii) the issuance of a contingent value right (“CVR”) initially valued at $6.5 million.
The CVR was valued using a valuation model that probability-weights expected outcomes (ranging from 50% to 100%) and discounts those amounts to their present value, using an appropriate discount rate (these represent unobservable inputs and are therefore classified as Level 3 inputs – see Note 2 (xiii)). The CVR has a maximum payout of $195 million if all sales and regulatory approval milestones are achieved, as summarized below:
| |
• | $5 million upon the achievement of net sales of MARQIBO in excess of $30 million in any calendar year |
| |
• | $10 million upon the achievement of net sales of MARQIBO in excess of $60 million in any calendar year |
| |
• | $25 million upon the achievement of net sales of MARQIBO in excess of $100 million in any calendar year |
| |
• | $50 million upon the achievement of net sales of MARQIBO in excess of $200 million in any calendar year |
| |
• | $100 million upon the achievement of net sales of MARQIBO in excess of $400 million in any calendar year; and |
| |
• | $5 million upon receipt of marketing authorization from the FDA regarding Menadione Topical Lotion |
Talon CVR Fair Value as of June 30, 2018 and December 31, 2017
The CVR fair value will continue to be evaluated on a quarterly basis. Current and future changes in its fair value results from the likelihood and timing of milestone achievement and/or the corresponding discount rate applied thereon. Adjustments to CVR fair value are recognized within “change in fair value of contingent consideration related to acquisitions” in the accompanying Condensed Consolidated Statements of Operations.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
|
| | | |
| Fair Value of Talon CVR |
December 31, 2017 | $ | 6,210 |
|
Fair value adjustment for the six months ended June 30, 2018 | 483 |
|
June 30, 2018 | $ | 6,693 |
|
(b) Acquisition of Rights to EVOMELA and Related Contingent Consideration
Overview of Acquisition of Rights to EVOMELA
In March 2013, we completed the acquisition of exclusive global development and commercialization rights to Captisol-enabled®, propylene glycol-free MELPHALAN (which we branded as “EVOMELA”) for use as a conditioning treatment prior to autologous stem cell transplant for patients with MM. We acquired these rights from CyDex a wholly-owned subsidiary of Ligand for an initial license fee of $3 million, and assumed responsibility for EVOMELA’s then-ongoing clinical and regulatory development program. We accounted for this transaction as a business combination, which required that assets acquired and liabilities assumed be recognized on the balance sheet at their fair values as of the transaction date.
We are required to pay Ligand additional amounts up to an aggregate $60 million upon the achievement of annual net sales thresholds (exclusive of the $6 million milestone payment triggered in March 2016, as discussed below), however, we do not expect to achieve these sales thresholds based on our estimated market size for this product and our projected market share at the time of the acquisition and to date. We also must pay Ligand royalties of 20% on our net sales of EVOMELA in all territories.
Our EVOMELA royalty obligation and sales-based milestones are jointly treated as part of an “executory contract” (as defined under GAAP) that is connected with an at-market supply agreement for Captisol that was executed concurrently with this acquisition (requiring the continuing involvement of CyDex). As a result, our royalty obligation and sales-based milestone arrangements are treated as separate transactions, distinct from the consideration for the EVOMELA rights. Our royalty expenses are reported through “cost of sales” in our Condensed Consolidated Statements of Operations in the same period of our recognized revenue for the product sale.
Consideration Transferred
The acquisition-date fair value of the consideration transferred consisted of the following:
|
| | | |
| |
Cash consideration | $ | 3,000 |
|
Ligand contingent consideration | 4,700 |
|
Total purchase consideration | $ | 7,700 |
|
Fair Value Estimate of Asset Acquired and Liability Assumed
The total purchase consideration is allocated to the acquisition of the net tangible and intangible assets based on their estimated fair values as of the transaction date. The allocation of the total purchase price to the net assets acquired is as follows:
|
| | | |
EVOMELA IPR&D rights | $ | 7,700 |
|
We estimated the fair value of the in-process research and development using the income approach. The income approach uses valuation techniques to convert future net cash flows to a single present value (discounted) amount. We applied our net cash flow projections for EVOMELA over 10 years and a discount rate of 25%, taking into account our estimates of future incremental earnings that may be achieved upon regulatory approval and commercialization of the product(s). The fair value of the Ligand Contingent Consideration (as defined below) liability was determined using the probability of success and the discounted cash flow method of the income approach (representing unobservable “Level 3” inputs (see Note 2(xiii)) for regulatory and sales-based milestones due to Ligand upon achievement).
In March 2016, the FDA approved EVOMELA, triggering a $6 million milestone payment to Ligand (“Ligand Contingent Consideration”) that was paid in April 2016. “EVOMELA IPR&D” of $7.7 million was reclassified in April 2016 to “EVOMELA distribution rights” that is reported within “Intangible assets, net of accumulated amortization” in the
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
accompanying Condensed Consolidated Balance Sheets as of June 30, 2018 (see Note 3(f)). Amortization related to this intangible asset commenced on April 1, 2016.
(c) Allos Acquisition
We acquired Allos Therapeutics, Inc. (“Allos”) in September 2012 for cash consideration of $205.2 million and assumed its FOLOTYN distribution rights (see Note 14). We accounted for this transaction as a business combination, which required that assets acquired and liabilities assumed be reported on our balance sheet at their fair values as of the transaction date. We have no ongoing contingent consideration obligations from this transaction.
10. OUT-LICENSE OF MARQIBO, ZEVALIN, & EVOMELA IN CHINA TERRITORY
Overview of CASI Out-License
In September 2014, we executed three product out-license agreements with a perpetual term with CASI, a publicly-traded biopharmaceutical company (NASDAQ: CASI) with a primary focus on the China market (collectively, the “CASI Out-License”). Under the CASI Out-License, we granted CASI the exclusive rights to distribute ZEVALIN, MARQIBO, and EVOMELA (“CASI Out-Licensed Products”), in greater China (which includes Taiwan, Hong Kong and Macau). CASI is responsible for the development and commercialization of these drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China. We will provide CASI with future commercial supply of the CASI Out-Licensed Products under typical market terms. Our consideration consisted of CASI common stock in return for their distribution rights of ZEVALIN and EVOMELA, and a secured promissory note for their distribution rights of MARQIBO.
Our Ownership in CASI at June 30, 2018
Under certain conditions that expired in December 2017, we had a right to purchase additional shares of CASI common stock in order to maintain our post-investment ownership percentage if CASI issued additional securities. During 2017 and 2016, we acquired an additional 1.5 million and 4.6 million common shares of CASI, respectively, at par value. Our aggregate holding of 11.5 million CASI common shares as of June 30, 2018 represented an approximate 13.3% ownership, with a fair market value of $95.0 million (see Note 3(a)).
Proceeds Received from CASI in 2014
The proceeds we received in 2014, and its fair value on the CASI Out-License execution date, consisted of the following:
|
| | | | |
CASI common stock (5.4 million shares) | $ | 8,649 |
| (a) |
CASI secured promissory note, net of fair value discount ($1.5 million face value and 0.5% annual coupon) | 1,310 |
| (b) |
Total consideration received, net of fair value discount | $ | 9,959 |
| (c) |
| |
(a) | Value determined based on the September 17, 2014 closing price of 5.4 million shares of CASI common stock on the NASDAQ Capital Market of $1.60 per share. |
| |
(b) | Value estimated using the terms of the $1.5 million promissory note, the application of a synthetic debt rating based on CASI’s publicly-available financial information, and the prevailing interest yields on similar public debt securities as of September 17, 2014. This full balance was reclassified beginning December 31, 2017 to “other assets” (presented within non-current assets on the accompanying Condensed Consolidated Balance Sheets) from “other receivables” (presented within current assets) due to an amended maturity date of September 17, 2019. |
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(c) | Presented within “license fees and service revenue” in the Consolidated Statements of Operations for the year ended December 31, 2015 (see below). |
In addition, CASI will be responsible for paying any royalties or milestones that we are obligated to pay to our third-party licensors resulting from the achievement of certain milestones and/or sales of CASI Out-Licensed Products, but only to the extent of the greater China portion of such royalties or milestones.
License Fee Revenue Recognized in 2015
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
The $9.7 million value of the upfront proceeds (undiscounted, and net of certain foreign exchange adjustments) from CASI were recognized in 2015 within “license fees and service revenue” on our Consolidated Statements of Operations. The delayed timing of this revenue recognition corresponded with the execution of certain supply agreements with CASI for ZEVALIN, MARQIBO, and EVOMELA. These agreements allow CASI to procure CASI Out-Licensed Products directly from approved third parties, and in such case, do not require our future involvement for its commercial supply.
11. OUT-LICENSE OF ZEVALIN IN CERTAIN EX-U.S. TERRITORIES
In November 2015, we entered into an out-license agreement with Mundipharma for its commercialization of ZEVALIN in Asia (excluding India and greater China), Australia, New Zealand, Africa, the Middle East, and Latin America (including the Caribbean). In return, we received $18 million (comprised of $15 million received in December 2015 and $3 million received in January 2016). Of these proceeds, $15 million was recognized and reported within “license fees and service revenue” in the fourth quarter of 2015, and the remaining $3 million payment was recognized in full by June 30, 2017.
In April 2018, we received $2 million due to Mundipharma’s achievement of a specified sales milestone which was recognized in the first quarter of 2018 and reported within “license fees and service revenue” on our accompanying Condensed Consolidated Statements of Operations for the six months ended June 30, 2018 (see Note 5). Mundipharma is required to reimburse us for our payment of royalties due to Bayer Pharma AG (“Bayer”) from its ZEVALIN sales - see Note 15(b)(ii).
12. CO-PROMOTION ARRANGEMENT WITH EAGLE PHARMACEUTICALS
In November 2015, we executed an agreement with Eagle Pharmaceuticals, Inc. (“Eagle”) whereby designated members of our sales force will concurrently market up to six of Eagle’s products along with our products, in return for fixed monthly payments (aggregating $12.8 million), as well as variable sales-based milestones, over an 18 month contract term that commenced on January 1, 2016 and ended on June 30, 2017 (the “Eagle Agreement”). On July 1, 2017, our sales force ceased marketing Eagle products and the Eagle Agreement expired under its terms.
The fixed receipts from Eagle for our sales activities, as well as reimbursements of third-party marketing services, are recognized within “license fees and service revenue” on our accompanying Condensed Consolidated Statements of Operations, and was $2.4 million and $4.7 million for the three and six months ended June 30, 2017. No sales-based milestones were achieved.
An allocation of our sales personnel costs that are dedicated to Eagle sales activities are reported within “cost of service revenue” on our accompanying Condensed Consolidated Statements of Operations, as are reimbursable costs for Eagle marketing activities. These were an aggregate $2.1 million and $4.2 million for the three and six months ended June 30, 2017.
13. CONVERTIBLE SENIOR NOTES
Overview of Convertible Notes and Conversion Hedge
On December 17, 2013, we entered into an agreement for the sale of $120 million aggregate principal amount of 2.75% Convertible Senior Notes (equaling 120,000 notes, denominated in $1,000 principal units) due December 2018 (the “2018 Convertible Notes”). As of June 30, 2018 and December 31, 2017, $40.6 million of principal of the 2018 Convertible Notes was outstanding due to our open market purchases discussed below.
The 2018 Convertible Notes are convertible into shares of our common stock at a conversion rate of 95 shares per $1,000 principal units, equating to 3.9 million common shares if fully converted at June 30, 2018. The in-the-money conversion price is equivalent to $10.53 per common share. The conversion rate and conversion price is subject to adjustment under certain limited circumstances. The 2018 Convertible Notes bear interest at a rate of 2.75% per year, payable semiannually in arrears on June 15 and December 15 of each year. The 2018 Convertible Notes will mature and become payable on December 15, 2018, subject to earlier conversion into common stock at the holders’ option.
The sale of the 2018 Convertible Notes closed on December 23, 2013 and we received net proceeds of $115.4 million, after deducting banker and professional fees of $4.6 million. We used a portion of these net proceeds to simultaneously enter into “bought call” and “sold warrant” transactions with Royal Bank of Canada (collectively, the “Conversion Hedge”). We recorded the Conversion Hedge on a net cost basis of $13.1 million, as a reduction to “additional paid-in capital” in our accompanying Condensed Consolidated Balance Sheets. Under applicable GAAP, the Conversion Hedge transaction has not been (and is not expected to be) marked-to-market through earnings or comprehensive income.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
On and after June 15, 2018, and until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or a portion of their 2018 Convertible Notes. Our stockholders’ approved “flexible settlement” at our Annual Meeting of Stockholders on June 29, 2015. As a result, we may (at our election) settle any future conversions of the 2018 Convertible Notes by paying or delivering cash, shares of our common stock, or a combination of cash and shares of common stock. However, if the holders of the 2018 Convertible Notes do not elect to convert into shares of our common stock, our December 2018 obligation to repay the principal amount of $40.6 million in cash, plus any accrued and unpaid interest, will remain unchanged.
Open Market Purchases of 2018 Convertible Notes and Conversion Hedge Unwind in December 2016 and October 2017
In December 2016, we completed two open market purchases of our 2018 Convertible Notes, aggregating 9,963 note units (equivalent to $10 million principal value) for $9.0 million. We recognized an aggregate loss of $25 thousand on the retirement of these 2018 Convertible Notes (based on its carrying value under GAAP), which is included in “other income (expense), net” on the Consolidated Statements of Operations for the year ended December 31, 2016. Concurrent with these two open market purchases in December 2016, we unwound a portion of our previously sold warrants and previously purchased call options (which were part of our Conversion Hedge described below) for aggregate net proceeds of $21 thousand. We recorded a corresponding net increase to “additional paid-in capital” in the Consolidated Balance Sheets as of December 31, 2016.
In October 2017, we completed an additional open market purchase of our 2018 Convertible Notes, aggregating 69,472 note units (equivalent to $69.5 million principal value) for $27.3 million in cash and 5.4 million newly-issued shares of our common stock, then worth $73 million. We recognized a loss of $0.8 million on the retirement of these 2018 Convertible Notes (based on its carrying value under GAAP), which was included in “other (expense) income, net” on the Consolidated Statements of Operations for the year ended December 31, 2017. Accordingly, as of June 30, 2018 and December 31, 2017, $40.6 million in principal of our 2018 Convertible Notes remained outstanding.
Concurrent with this open market purchase in October 2017, we also unwound a portion of the previously sold warrants and previously purchased call options that were part of our Conversion Hedge for aggregate net proceeds of $5.8 million. We recorded a corresponding net increase to “additional paid-in capital” in the Consolidated Balance Sheets as of December 31, 2017.
We entered into Conversion Hedge transactions in December 2013 to reduce the potential dilution to our stockholders and/or offset any cash payments that we are required to make in excess of the principal amount, upon conversion of the 2018 Convertible Notes (in the event that the market price of our common stock is greater than the conversion price). The strike price of the “bought call” is equal to the conversion price and conversion rate of the 2018 Convertible Notes (at such time, it matched the 11.4 million common shares into which the holders could convert the 2018 Convertible Notes); the strike price of our “sold warrant” is $14.03 per share of our common stock, and is also for 11.4 million common shares (reduced by the partial unwinding of these instruments, as discussed above).
Carrying Value and Fair Value of 2018 Convertible Notes at June 30, 2018 and December 31, 2017
The carrying value of the 2018 Convertible Notes as of June 30, 2018 and December 31, 2017, is summarized as follows:
|
| | | | | | | |
| June 30, 2018 | | December 31, 2017 |
Principal amount | $ | 40,565 |
| | $ | 40,565 |
|
(Less): Unamortized debt discount (amortized through December 2018) | (1,022 | ) | | (2,101 | ) |
(Less): Debt issuance costs | (116 | ) | | (240 | ) |
Carrying value | $ | 39,427 |
| | $ | 38,224 |
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As of June 30, 2018 and December 31, 2017, the estimated aggregate fair value of the 2018 Notes is $81.0 million and $74.3 million, respectively. These estimated fair values represent a Level 2 measurement (see Note 2(xiii)), based upon the 2018 Convertible Notes quoted bid price at each date in a thinly-traded market.
Components of Interest Expense on 2018 Convertible Notes
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, per unit, and number of years)
(Unaudited)
The following table sets forth the components of interest expense recognized in the accompanying Condensed Consolidated Statements of Operations for the 2018 Convertible Notes for the three and six months ended June 30, 2018 and 2017: |
| | | | | | | | | | | | | | | |
| Three months ended June 30, | | Six months ended June 30, |
| 2018 | | 2017 | | 2018 | | 2017 |
Contractual coupon interest expense | $ | 279 |
| | $ | 757 |
| | $ | 558 |
| | $ | |