☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(617) (§ Non-accelerated filer ☐ Securities registered pursuant to Section 12(b) of the Act:Title of each classTradingSymbol(s)Name of each exchangeon which registeredCommon Stock, $0.0001 par valueKPTINasdaq Global Select MarketApril 30,October 29, 2019, there were 60,864,44562,790,043 shares of Common Stock, $0.0001 par value per share, outstanding.
Item 1. | 3 | |||||
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Item 2. | 29 | |||||
Item 3. | 36 | |||||
Item 4. | 36 | |||||
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Item 1. | 37 | |||||
Item 1.A. | 37 | |||||
Item 6. | 78 | |||||
79 |
Item 1. | Condensed Consolidated Financial Statements (Unaudited). |
March 31, 2019 | December 31, 2018 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 83,506 | $ | 118,021 | ||||
Short-term investments | 180,918 | 210,178 | ||||||
Prepaid expenses and other current assets | 7,011 | 6,413 | ||||||
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Total current assets | 271,435 | 334,612 | ||||||
Property and equipment, net | 3,617 | 3,863 | ||||||
Operating leaseright-of-use assets | 11,448 | — | ||||||
Long-term investments | — | 2,001 | ||||||
Restricted cash | 714 | 716 | ||||||
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Total assets | $ | 287,214 | $ | 341,192 | ||||
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Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,266 | $ | 4,332 | ||||
Accrued expenses | 28,868 | 32,493 | ||||||
Deferred revenue | 10,650 | 9,362 | ||||||
Operating lease liabilities | 1,375 | — | ||||||
Deferred rent | — | 390 | ||||||
Other current liabilities | 701 | 327 | ||||||
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Total current liabilities | 43,860 | 46,904 | ||||||
Convertible senior notes | 104,368 | 102,664 | ||||||
Operating lease liabilities, net of current portion | 14,457 | — | ||||||
Deferred revenue, net of current portion | 3,245 | 4,532 | ||||||
Deferred rent, net of current portion | — | 3,922 | ||||||
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Total liabilities | 165,930 | 158,022 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding | — | — | ||||||
Common stock, $0.0001 par value; 100,000,000 shares authorized; 60,864,445 and 60,829,308 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 6 | 6 | ||||||
Additionalpaid-in capital | 861,215 | 857,156 | ||||||
Accumulated other comprehensive loss | (28 | ) | (244 | ) | ||||
Accumulated deficit | (739,909 | ) | (673,748 | ) | ||||
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Total stockholders’ equity | 121,284 | 183,170 | ||||||
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Total liabilities and stockholders’ equity | $ | 287,214 | $ | 341,192 | ||||
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September 30, 2019 | December 31, 2018 | |||||||||||||||||||||||
Assets | ||||||||||||||||||||||||
Current assets: | ||||||||||||||||||||||||
Cash and cash equivalents | $ | 168,004 | $ | 118,021 | ||||||||||||||||||||
Short-term investments | 99,525 | 210,178 | ||||||||||||||||||||||
Accounts receivable | 7,928 | — | ||||||||||||||||||||||
Inventory | 100 | — | ||||||||||||||||||||||
Prepaid expenses and other current assets | 5,310 | 6,413 | ||||||||||||||||||||||
Total current assets | 280,867 | 334,612 | ||||||||||||||||||||||
Property and equipment, net | 3,240 | 3,863 | ||||||||||||||||||||||
Operating lease right-of-use assets | 10,904 | — | ||||||||||||||||||||||
Long-term investments | 2,022 | 2,001 | ||||||||||||||||||||||
Restricted cash | 712 | 716 | ||||||||||||||||||||||
Total assets | $ | 297,745 | $ | 341,192 | ||||||||||||||||||||
Liabilities and stockholders’ equity | ||||||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||||||
Accounts payable | $ | 3,068 | $ | 4,332 | ||||||||||||||||||||
Accrued expenses | 32,421 | 32,493 | ||||||||||||||||||||||
Deferred revenue | 1,053 | 9,362 | ||||||||||||||||||||||
Operating lease liabilities | 1,583 | — | ||||||||||||||||||||||
Deferred rent | — | 390 | ||||||||||||||||||||||
Other current liabilities | 1,077 | 327 | ||||||||||||||||||||||
Total current liabilities | 39,202 | 46,904 | ||||||||||||||||||||||
Convertible senior notes | 107,962 | 102,664 | ||||||||||||||||||||||
Deferred royalty obligation | 73,589 | — | ||||||||||||||||||||||
Operating lease liabilities, net of current portion | 13,643 | — | ||||||||||||||||||||||
Deferred revenue, net of current portion | 3,479 | 4,532 | ||||||||||||||||||||||
Deferred rent, net of current portion | — | 3,922 | ||||||||||||||||||||||
Total liabilities | 237,875 | 158,022 | ||||||||||||||||||||||
Stockholders’ equity: | ||||||||||||||||||||||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; NaN issued and outstanding | — | — | ||||||||||||||||||||||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 62,705,481 shares issued and outstanding at September 30, 2019; 100,000,000 shares authorized; 60,829,308 shares issued and outstanding at December 31, 2018 | 6 | 6 | ||||||||||||||||||||||
Additional paid-in capital | 884,585 | 857,156 | ||||||||||||||||||||||
Accumulated other comprehensive loss | (30 | ) | (244 | ) | ||||||||||||||||||||
Accumulated deficit | (824,691 | ) | (673,748 | ) | ||||||||||||||||||||
Total stockholders’ equity | 59,870 | 183,170 | ||||||||||||||||||||||
Total liabilities and stockholders’ equity | $ | 297,745 | $ | 341,192 | ||||||||||||||||||||
Three Months Ended, March 31, | ||||||||
2019 | 2018 | |||||||
License and other revenue | $ | 155 | $ | 10,000 | ||||
Operating expenses: | ||||||||
Research and development | 37,974 | 41,321 | ||||||
General and administrative | 27,103 | 7,621 | ||||||
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Total operating expenses | 65,077 | 48,942 | ||||||
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Loss from operations | (64,922 | ) | (38,942 | ) | ||||
Other income (expense): | ||||||||
Interest income | 1,771 | 509 | ||||||
Interest expense | (2,998 | ) | — | |||||
Other expense | (2 | ) | (14 | ) | ||||
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Total other income (expense), net | (1,229 | ) | 495 | |||||
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Loss before income taxes | (66,151 | ) | (38,447 | ) | ||||
Income tax provision | (10 | ) | (12 | ) | ||||
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Net loss | $ | (66,161 | ) | $ | (38,459 | ) | ||
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Net loss per share—basic and diluted | $ | (1.09 | ) | $ | (0.78 | ) | ||
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Weighted-average number of common shares outstanding used in net loss per share—basic and diluted | 60,856,295 | 49,602,809 | ||||||
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Three Months Ended, September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||||||||
Product revenue, net | $ | 12,821 | $ | — | $ | 12,821 | $ | — | ||||||||||||||||||||||||
License and other revenue | 328 | 239 | 9,976 | 30,130 | ||||||||||||||||||||||||||||
Total revenues | 13,149 | 239 | 22,797 | 30,130 | ||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||
Cost of sales | 1,013 | — | 1,013 | — | ||||||||||||||||||||||||||||
Research and development | 26,270 | 36,427 | 90,761 | 122,482 | ||||||||||||||||||||||||||||
Selling, general and administrative | 25,267 | 12,966 | 77,032 | 30,076 | ||||||||||||||||||||||||||||
Total operating expenses | 52,550 | 49,393 | 168,806 | 152,558 | ||||||||||||||||||||||||||||
Loss from operations | (39,401 | ) | (49,154 | ) | (146,009 | ) | (122,428 | ) | ||||||||||||||||||||||||
Other income (expense): | ||||||||||||||||||||||||||||||||
Interest income | 1,137 | 1,098 | 4,320 | 2,260 | ||||||||||||||||||||||||||||
Interest expense | (3,093 | ) | — | (9,180 | ) | — | ||||||||||||||||||||||||||
Other income (expense) | 10 | (13 | ) | (36 | ) | (20 | ) | |||||||||||||||||||||||||
Total other (expense) income, net | (1,946 | ) | 1,085 | (4,896 | ) | 2,240 | ||||||||||||||||||||||||||
Loss before income taxes | (41,347 | ) | (48,069 | ) | (150,905 | ) | (120,188 | ) | ||||||||||||||||||||||||
Income tax provision | (20 | ) | (14 | ) | (38 | ) | (9 | ) | ||||||||||||||||||||||||
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Net loss | $ | (41,367 | ) | $ | (48,083 | ) | $ | (150,943 | ) | $ | (120,197 | ) | ||||||||||||||||||||
Net loss per share—basic and diluted | $ | (0.67 | ) | $ | (0.79 | ) | $ | (2.46 | ) | $ | (2.17 | ) | ||||||||||||||||||||
Weighted-average number of common shares outstanding used in net loss per share—basic and diluted | 62,092,841 | 60,586,511 | 61,297,249 | 55,465,261 | ||||||||||||||||||||||||||||
Three Months Ended March 31, | ||||||||
2019 | 2018 | |||||||
Net loss | $ | (66,161 | ) | $ | (38,459 | ) | ||
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Comprehensive income (loss) | ||||||||
Unrealized gain (loss) on investments | 257 | (108 | ) | |||||
Foreign currency translation adjustments | (41 | ) | 39 | |||||
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Comprehensive loss | $ | (65,945 | ) | $ | (38,528 | ) | ||
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Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||||||||||||||||||
Net loss | $ | (41,367 | ) | $ | (48,083 | ) | $ | (150,943 | ) | $ | (120,197 | ) | ||||||||||||||||||||
Comprehensive income (loss) | ||||||||||||||||||||||||||||||||
Unrealized (loss) gain on investments | (59 | ) | 110 | 250 | 105 | |||||||||||||||||||||||||||
Foreign currency translation adjustments | (32 | ) | (3 | ) | (36 | ) | (41 | ) | ||||||||||||||||||||||||
Comprehensive loss | $ | (41,458 | ) | $ | (47,976 | ) | $ | (150,729 | ) | $ | (120,133 | ) | ||||||||||||||||||||
Three Months Ended March 31, | ||||||||
2019 | 2018 | |||||||
Operating activities | ||||||||
Net loss | $ | (66,161 | ) | $ | (38,459 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 245 | 169 | ||||||
Net amortization of premiums and discounts on investments | (522 | ) | 160 | |||||
Amortization of debt discount and issuance costs | 1,704 | — | ||||||
Stock-based compensation expense | 3,907 | 4,164 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | (597 | ) | (638 | ) | ||||
Operating leaseright-of-use assets | 263 | — | ||||||
Accounts payable | (2,016 | ) | (773 | ) | ||||
Accrued expenses and other liabilities | (3,255 | ) | 295 | |||||
Operating lease liabilities | (191 | ) | — | |||||
Deferred rent | — | 430 | ||||||
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Net cash used in operating activities | (66,623 | ) | (34,652 | ) | ||||
Investing activities | ||||||||
Purchases of property and equipment | (49 | ) | (382 | ) | ||||
Proceeds from maturities of investments | 60,033 | 27,602 | ||||||
Purchases of investments | (27,993 | ) | (24,736 | ) | ||||
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Net cash provided by investing activities | 31,991 | 2,484 | ||||||
Financing activities | ||||||||
Proceeds from the exercise of stock options and shares issued under employee stock purchase plan | 152 | 429 | ||||||
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Net cash provided by financing activities | 152 | 429 | ||||||
Effect of exchange rate on cash, cash equivalents and restricted cash | (37 | ) | 43 | |||||
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Net decrease in cash, cash equivalents and restricted cash | (34,517 | ) | (31,696 | ) | ||||
Cash, cash equivalents and restricted cash at beginning of period | 118,737 | 69,487 | ||||||
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Cash, cash equivalents and restricted cash at end of period | $ | 84,220 | $ | 37,791 | ||||
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Reconciliation of cash, cash equivalents and restricted cash reported within the condensed | ||||||||
Cash and cash equivalents | $ | 83,506 | $ | 37,499 | ||||
Long-term restricted cash | 714 | 292 | ||||||
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Total cash, cash equivalents and restricted cash | $ | 84,220 | $ | 37,791 | ||||
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Supplemental disclosures: | ||||||||
Operating leaseright-of-use assets obtained in exchange for operating lease liabilities | $ | 11,711 | $ | — | ||||
Cash paid for amounts included in the measurement of operating lease liabilities | $ | 630 | $ | — |
Nine Months Ended September 30, | ||||||||||||||||
2019 | 2018 | |||||||||||||||
Operating activities | ||||||||||||||||
Net loss | $ | (150,943 | ) | $ | (120,197 | ) | ||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
Depreciation and amortization | 730 | 541 | ||||||||||||||
Net amortization of premiums and discounts on investments | (1,242 | ) | 280 | |||||||||||||
Amortization of debt discount and issuance costs | 5,298 | — | ||||||||||||||
Stock-based compensation expense | 11,742 | 13,378 | ||||||||||||||
Changes in operating assets and liabilities: | ||||||||||||||||
Accounts r eceivable | (7,928 | ) | — | |||||||||||||
Inventory | (100 | ) | — | |||||||||||||
Prepaid expenses and other current assets | 1,108 | (3,039 | ) | |||||||||||||
Operating lease right-of-use assets | 807 | — | ||||||||||||||
Accounts payable | (1,215 | ) | (3,425 | ) | ||||||||||||
Accrued expenses and other liabilities | 569 | 8,139 | ||||||||||||||
Operating lease liabilities | (797 | ) | — | |||||||||||||
Deferred revenue | (9,362 | ) | (8,027 | ) | ||||||||||||
Deferred rent | — | 1,405 | ||||||||||||||
Net cash used in operating activities | (151,333 | ) | (110,945 | ) | ||||||||||||
Investing activities | ||||||||||||||||
Purchases of property and equipment | (156 | ) | (1,270 | ) | ||||||||||||
Proceeds from maturities of investments | 202,454 | 94,378 | ||||||||||||||
Purchases of investments | (90,329 | ) | (97,662 | ) | ||||||||||||
Net cash provided by (used in) investing activities | 111,969 | (4,554 | ) | |||||||||||||
Financing activities | ||||||||||||||||
Proceeds from the issuance of common stock, net of issuance costs | 14,563 | 145,706 | ||||||||||||||
Proceeds from the exercise of stock options and shares issued under employee stock purchase plan | 1,124 | 2,627 | ||||||||||||||
Proceeds from deferred royalty obligation, net | 73,682 | — | ||||||||||||||
Net cash provided by financing activities | 89,369 | 148,333 | ||||||||||||||
Effect of exchange rate on cash, cash equivalents and restricted cash | (26 | ) | (9 | ) | ||||||||||||
Net increase in cash, cash equivalents and restricted cash | 49,979 | 32,825 | ||||||||||||||
Cash, cash equivalents and restricted cash at beginning of period | 118,737 | 69,487 | ||||||||||||||
Cash, cash equivalents and restricted cash at end of period | $ | 168,716 | $ | 102,312 | ||||||||||||
Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets | ||||||||||||||||
Cash and cash equivalents | $ | 168,004 | $ | 101,600 | ||||||||||||
Long-term restricted cash | 712 | 712 | ||||||||||||||
Total cash, cash equivalents and restricted cash | $ | 168,716 | $ | 102,312 | ||||||||||||
Supplemental disclosures: | ||||||||||||||||
Deferred financing costs in a ccrued expenses at period end | $ | 93 | $ | — | ||||||||||||
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | $ | 11,711 | $ | — | ||||||||||||
Cash paid for amounts included in the measurement of operating lease liabilities | $ | 2,096 | $ | — |
Common Shares | ||||||||||||||||||||||||
Shares | Amount | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders’ Equity (Deficit) | |||||||||||||||||||
Balance at December 31, 2018 | 60,829,308 | $ | 6 | $ | 857,156 | $ | (244 | ) | $ | (673,748 | ) | $ | 183,170 | |||||||||||
Vesting of restricted stock | 5,000 | — | — | — | — | — | ||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan | 30,137 | — | 152 | — | — | 152 | ||||||||||||||||||
Stock-based compensation expense | — | — | 3,907 | — | — | 3,907 | ||||||||||||||||||
Unrealized gain on investments | — | — | — | 257 | — | 257 | ||||||||||||||||||
Foreign currency translation adjustment | — | — | — | (41 | ) | — | (41 | ) | ||||||||||||||||
Net loss | — | — | — | — | (66,161 | ) | (66,161 | ) | ||||||||||||||||
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Balance at March 31, 2019 | 60,864,445 | $ | 6 | $ | 861,215 | $ | (28 | ) | $ | (739,909 | ) | $ | 121,284 | |||||||||||
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Balance at December 31, 2017 | 49,533,150 | $ | 5 | $ | 625,017 | $ | (217 | ) | $ | (495,341 | ) | $ | 129,464 | |||||||||||
Vesting of restricted stock | 5,000 | — | — | — | — | — | ||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan | 132,178 | — | 429 | — | — | 429 | ||||||||||||||||||
Stock-based compensation expense | — | — | 4,164 | — | — | 4,164 | ||||||||||||||||||
Unrealized gain on investments | — | — | — | (108 | ) | — | (108 | ) | ||||||||||||||||
Foreign currency translation adjustment | — | — | — | 39 | — | 39 | ||||||||||||||||||
Net loss | — | — | — | — | (38,459 | ) | (38,459 | ) | ||||||||||||||||
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Balance at March 31, 2018 | 49,670,328 | $ | 5 | $ | 629,610 | $ | (286 | ) | $ | (533,800 | ) | $ | 95,529 | |||||||||||
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Common Shares | ||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2019 | 60,965,505 | $ | 6 | $ | 865,726 | $ | 61 | $ | (783,324 | ) | $ | 82,469 | ||||||||||||||||||||||||||||||||||||
Vesting of restricted stock | 5,000 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan | 100,525 | — | 577 | — | — | 577 | ||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, net of issuance costs of $0.3 million | 1,634,451 | — | 14,563 | — | — | 14,563 | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | — | — | 3,719 | — | — | 3,719 | ||||||||||||||||||||||||||||||||||||||||||
Unrealized loss on investments | — | — | — | (59 | ) | — | (59 | ) | ||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | (32 | ) | — | (32 | ) | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | (41,367 | ) | (41,367 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2019 | 62,705,481 | $ | 6 | $ | 884,585 | $ | (30 | ) | $ | (824,691 | ) | $ | 59,870 | |||||||||||||||||||||||||||||||||||
Balance at June 30, 2018 | 60,501,260 | $ | 6 | $ | 781,176 | $ | (260 | ) | $ | (567,455 | ) | $ | 213,467 | |||||||||||||||||||||||||||||||||||
Vesting of restricted stock | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan | 163,597 | — | 812 | — | — | 812 | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | — | — | 4,775 | — | — | 4,775 | ||||||||||||||||||||||||||||||||||||||||||
Unrealized gain on investments | — | — | — | 110 | — | 110 | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | (3 | ) | — | (3 | ) | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | (48,083 | ) | (48,083 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2018 | 60,664,857 | $ | 6 | $ | 786,763 | $ | (153 | ) | $ | (615,538 | ) | $ | 171,078 | |||||||||||||||||||||||||||||||||||
Balance at December 31, 2018 | 60,829,308 | $ | 6 | 857,156 | $ | (244 | ) | $ | (673,748 | ) | $ | 183,170 | ||||||||||||||||||||||||||||||||||||
Vesting of restricted stock | 10,000 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan | 231,722 | — | 1,124 | — | — | 1,124 | ||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, net of issuance costs of $0.3 million | 1,634,451 | — | 14,563 | — | — | 14,563 | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | — | — | 11,742 | — | — | 11,742 | ||||||||||||||||||||||||||||||||||||||||||
Unrealized gain on investments | — | — | — | 250 | — | 250 | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | (36 | ) | — | (36 | ) | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | (150,943 | ) | (150,943 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2019 | 62,705,481 | $ | 6 | $ | 884,585 | $ | (30 | ) | $ | (824,691 | ) | $ | 59,870 | |||||||||||||||||||||||||||||||||||
Balance at December 31, 2017 | 49,533,150 | $ | 5 | $ | 625,053 | $ | (217 | ) | $ | (495,341 | ) | $ | 129,500 | |||||||||||||||||||||||||||||||||||
Vesting of restricted stock | 103,800 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan | 502,483 | — | 2,627 | — | — | 2,627 | ||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock, net of issuance costs of $0.2 million | 10,525,424 | 1 | 145,705 | — | — | 145,706 | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | — | — | 13,378 | — | — | 13,378 | ||||||||||||||||||||||||||||||||||||||||||
Unrealized gain on investments | — | — | — | 105 | — | 105 | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | (41 | ) | — | (41 | ) | ||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | (120,197 | ) | (120,197 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2018 | 60,664,857 | $ | 6 | $ | 786,763 | $ | (153 | ) | $ | (615,538 | ) | $ | 171,078 |
(in thousands except share and per share data)
At March 31,
Basis of Consolidation
The condensed consolidated financial statements at March 31, 2019 include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminatedStates, which commenced in consolidation.
The significant accounting policies used in preparation of these condensed consolidated financial statements onForm 10-Q for the three months ended March 31, 2019 are consistent with those discussed in Note 2 to the financial statements in the Company’s Annual Report onForm 10-K for the year ended December 31, 2018, except as it relates to the adoption of new accounting standards during the first three months of 2019 as discussed below.
July 2019.
also allows entities to make certain policy elections, some of which the Companywe elected, including: (i) a policy to not recordThe CompanyWe did not elect the use of hindsight in estimating the lease term for leases subject to transition to the new standard.
January 1, 2019 Prior to ASC 842 Adoption | ASC 842 Adjustment | January 1, 2019 as Adjusted | ||||||||||
Consolidated balance sheet data (in thousands): | ||||||||||||
Operating lease andright-of-use assets(1) | $ | — | $ | 11,711 | $ | 11,711 | ||||||
Deferred rent(2) | $ | 390 | $ | (390 | ) | $ | — | |||||
Deferred rentnon-current(2) | $ | 3,922 | $ | (3,922 | ) | $ | — | |||||
Operating lease liabilities(3) | $ | — | $ | 1,175 | $ | 1,175 | ||||||
Non-current operating lease liabilities(3) | $ | — | $ | 14,848 | $ | 14,848 |
January 1, 2019 Prior to ASC 842 Adoption | ASC 842 | | as Adjusted | ||||||||||||||||||||||
Consolidated balance sheet data (in thousands): | |||||||||||||||||||||||||
Operating lease and right-of-use assets (1) | | $ | — | $ | 11,711 | $ | 11,711 | | |||||||||||||||||
Deferred rent (2) | $ | 390 | $ | (390 | ) | $ | — | ||||||||||||||||||
Deferred rent non-current (2) | $ | 3,922 | $ | (3,922 | ) | $ | — | ||||||||||||||||||
Operating lease liabilities (3) | $ | — | $ | 1,175 | $ | 1,175 | |||||||||||||||||||
Non-current operating lease liabilities (3) | $ | — | $ | 14,848 | $ | 14,848 |
(1) | Represents capitalization of operating lease |
(2) | Represents reclassification of deferred rent and tenant incentives to operating lease |
(3) | Represents recognition of operating lease liabilities. |
The Company
clarify the effective date of the requirement. Under the guidance in C&DI 105.09, the Companywe implemented this updated disclosure requirement within thisbeginning with the Formequity for the three months ended March 31, 2019 and 2018.
equity.
September 30, 2019 | December 31, 2018 | |||||||||||||||||
Raw materials and work in process | $ | — | $ | — | ||||||||||||||
Finished goods | 100 | — | ||||||||||||||||
Total inventory | $ | 100 | $ | — | ||||||||||||||
Antengene is responsible for seeking regulatory and marketing approvals for the Antengene Licensed Compounds in the Antengene Territory, as well as any development of the products specifically necessary to obtain such approvals. Antengene is also responsible for the commercialization of the Antengene Licensed Compounds in the Oncology Field and
The Company
The Company
Companywe also estimated the standalone selling price for each of the material rights within the Antengene Transfer Options, and determined that such amounts were insignificant, and, therefore, immaterial for purposes of allocation. Accordingly, the Companywe allocated the $11,703$11.7 million transaction price amongst the Antengene Combined License Obligations as follows: $9,363$9.4 million for selinexor, $1,053$1.0 million for eltanexor, $1,053$1.1 million for$234$0.2 million for verdinexor. The Company believesWe believe that a change in the assumptions used to determine itsour best estimate of the stand-alone selling prices for any of the identified performance obligations would not have a significant effect on the allocation of the underlying transaction price to the performance obligations.
The Company
The CompanyWe assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Biogen, is a customer. The CompanyWe identified the following material promises in the arrangement: the Transfer of IP and the Manufacturing License. The CompanyWe also identified immaterial promises under the contract that were not deemed performance obligations. The CompanyWe further determined that other promises for Additional Supply and Transition Assistance represented customer options, which would create an obligation for the Companyus if exercised by Biogen. Since no additional or material consideration is owed to the Companyus by Biogen upon exercise of the customer options for Additional Supply and Transition Assistance, the Companywe determined that both are offered at significant and incremental discounts. Accordingly, they were assessed as material rights and, therefore, separate performance obligations in the arrangement. The CompanyWe then determined that the Transfer of IP and the Manufacturing License were not distinct from one another and must be combined as a performance obligation (the “Combined Performance Obligation”). This is because Biogen requires the Manufacturing License to derive benefit from the Transfer of IP. Based on these determinations, as well as the considerations noted above with respect to the material rights for Additional Supply and Transition Assistance, the Companywe identified three distinct performance obligations at the inception of the contract: (i) the Combined Performance Obligation, (ii) the material right for Additional Supply, and (iii) the material right for Transition Assistance. The CompanyWe further determined that the$10,000$10.0 million constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the performance obligations based on their relative stand-alone selling prices. In connection therewith, the Companywe estimated the stand-alone selling price of the (i) Combined Performance Obligation, (ii) material right for Additional Supply, and (iii) material right for Transition Assistance, and determined that the stand-alone selling price of the material rights for Additional Supply and Transition Assistance were insignificant based on various quantitative and qualitative considerations. Accordingly, the Companywe further determined that the allocation of the transaction price to the material rights for Additional Supply and Transition Assistance was insignificant. Based on the estimates of the stand-alone selling prices for each of the performance obligations, the Companywe determined that substantially all of the $10,000$10.0 million transaction price should be allocated to the Combined Performance Obligation. The Company believesWe believe that a change in the assumptions used to determine itsour best estimate of the stand-alone selling prices for the identified performance obligations would not have a significant effect on the allocation of the underlying transaction price to the performance obligations.
The Company
The Company
The Company
Upon execution of the Ono License Agreement, the transaction price included only the ¥2.5 billion (US$21,91621.9 million on the date received)the Company.us. As referenced above, the Company iswe are eligible to receive additional payments of up to ¥10.15 billion (approximately US$90.5 million at the exchange rate as of the Ono Effective Date) based on the achievement by Ono of future specified development milestones and up to ¥9.0 billion (approximately US$80.2 million at the exchange rate as of the Ono Effective Date) based on the achievement by Ono of future specified commercial milestones, as well as a low double-digit royalty based on future net sales of selinexor and eltanexor in the Ono Territory. In addition, the Companywe could receive cost reimbursement in connection with itsour promise to stand-ready to provide initial clinical supply for eltanexor in the future. The future regulatory milestones and cost reimbursement for providing initial clinical supply of eltanexor, both of which represent variable consideration, were evaluated under the most likely amount method, and were not included in the transaction price, because the amounts were fully constrained as of March 31,September 30, 2019. As part of itsour evaluation of the constraint, the Companywe considered numerous factors, including that receipt of such amounts is outside the control of the Company.our control. Separately, any consideration related to sales-based milestones, as well as royalties on net sales upon commercialization by Ono, will be recognized when the related sales occur, as they were determined to relate predominantly to the intellectual property granted to Ono and, therefore, have also been excluded from the transaction price in accordance with the sales-based royalty exception, as well as the Company’sour accounting policy. The CompanyWe will
The Company
The CompanyWe further determined that the$1,000$1.0 million upon contract execution, as well as the $250$0.3 million upon completion of the technology transfer, constituted the entirety of the consideration included in the transaction price as of the transition date, January 1, 2018, which was allocated to the performance obligations based on their relative stand-alone selling prices. In connection therewith, the Companywe estimated the stand-alone selling price of the (i) Anivive Combined License Obligation, (ii) material right for transfer of additional technology in the future, if developed by the Company,us, and (iii) the material right for facilitating manufacturing and supply relationships with the Company’sour third-party contract manufacturers, and determined that the stand-alone selling price of the material rights noted were insignificant based on various qualitative considerations. Accordingly, the Companywe further determined that the allocation of the upfront payment to the material rights noted was insignificant. Based on the estimates of the stand-alone selling prices for each of the performance obligations, the Companywe determined that substantially all of the $1,250$1.3 million transaction price should be allocated to the Anivive Combined License Obligation. The Company believesWe believe that a change in the assumptions used to determine itsour best estimate of the stand-alone selling prices for the identified performance obligations would not have a significant effect on the allocation of the underlying transaction price to the performance obligations.
4.
The Company is
Level 1 inputs | Quoted prices in active markets for identical assets or liabilities |
Level 2 inputs | Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly | |
Level 3 inputs | Unobservable inputs that reflect |
Description | Total | Quoted Prices in Active Markets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||
Financial assets | ||||||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 29,632 | $ | 29,632 | $ | — | $ | — | ||||||||
Commercial paper | 12,985 | — | 12,985 | — | ||||||||||||
U.S. government and agency securities | 1,499 | — | 1,499 | — | ||||||||||||
Investments: | ||||||||||||||||
Current: | ||||||||||||||||
Corporate debt securities | 112,105 | — | 112,105 | — | ||||||||||||
Commercial paper | 45,607 | — | 45,607 | — | ||||||||||||
U.S. government and agency securities | 19,207 | — | 19,207 | — | ||||||||||||
Certificate of deposit | 3,999 | — | 3,999 | — | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
$ | 225,034 | $ | 29,632 | $ | 195,402 | $ | — | |||||||||
|
|
|
|
|
|
|
|
Description | Total | Quoted Prices in Active Markets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||||||||||||||||||||||||||||||||||
Financial assets | ||||||||||||||||||||||||||||||||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||||||||||||||||||||||||||
Money market funds | $ | 78,063 | $ | 78,063 | $ | — | $ | — | ||||||||||||||||||||||||||||||||||||||||
Investments: | ||||||||||||||||||||||||||||||||||||||||||||||||
Short-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities | 49,708 | — | 49,708 | — | ||||||||||||||||||||||||||||||||||||||||||||
Commercial paper | 36,440 | — | 36,440 | — | ||||||||||||||||||||||||||||||||||||||||||||
U.S. government and agency securities | 13,377 | 13,377 | ||||||||||||||||||||||||||||||||||||||||||||||
Long-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities | 2,022 | 2,022 | ||||||||||||||||||||||||||||||||||||||||||||||
Total financial assets | $ | 179,610 | $ | 78,063 | $ | 101,547 | $ | — | ||||||||||||||||||||||||||||||||||||||||
Description | Total | Quoted Prices in Active Markets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||
Financial assets | ||||||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 62,320 | $ | 62,320 | $ | — | $ | — | ||||||||
Corporate debt securities | 6,823 | — | 6,823 | — | ||||||||||||
Commercial paper | 7,738 | — | 7,738 | — | ||||||||||||
Investments: | ||||||||||||||||
Current: | ||||||||||||||||
Corporate debt securities | 143,079 | — | 143,079 | — | ||||||||||||
Commercial paper | 43,978 | — | 43,978 | — | ||||||||||||
U.S. government and agency securities | 19,124 | — | 19,124 | — | ||||||||||||
Certificate of deposit | 3,997 | — | 3,997 | — | ||||||||||||
Non-current: | ||||||||||||||||
Corporate debt securities (one to two year maturity) | 2,001 | — | 2,001 | — | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
$ | 289,060 | $ | 62,320 | $ | 226,740 | $ | — | |||||||||
|
|
|
|
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|
|
|
Description | Total | Quoted Prices in Active Markets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||||||||||||||||||||||||||||||||||
Financial assets | ||||||||||||||||||||||||||||||||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||||||||||||||||||||||||||
Money market funds | $ | 62,320 | $ | 62,320 | $ | — | $ | — | ||||||||||||||||||||||||||||||||||||||||
Corporate debt securities | 6,823 | — | 6,823 | — | ||||||||||||||||||||||||||||||||||||||||||||
Commercial paper | 7,738 | — | 7,738 | — | ||||||||||||||||||||||||||||||||||||||||||||
Investments: | ||||||||||||||||||||||||||||||||||||||||||||||||
Short-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities | 143,079 | — | 143,079 | — | ||||||||||||||||||||||||||||||||||||||||||||
Commercial paper | 43,978 | — | 43,978 | — | ||||||||||||||||||||||||||||||||||||||||||||
U.S. government and agency securities | 19,124 | — | 19,124 | — | ||||||||||||||||||||||||||||||||||||||||||||
Certificate of deposit | 3,997 | — | 3,997 | — | ||||||||||||||||||||||||||||||||||||||||||||
Long-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities (one to two year maturity) | 2,001 | — | 2,001 | — | ||||||||||||||||||||||||||||||||||||||||||||
$ | 289,060 | $ | 62,320 | $ | 226,740 | $ | — | |||||||||||||||||||||||||||||||||||||||||
5.
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Loss | Fair Value | |||||||||||||
Current: | ||||||||||||||||
Corporate debt securities | $ | 112,099 | $ | 48 | $ | (42 | ) | $ | 112,105 | |||||||
Commercial paper | 45,580 | 28 | (1 | ) | 45,607 | |||||||||||
U.S. government and agency securities | 19,197 | 19 | (9 | ) | 19,207 | |||||||||||
Certificate of deposit | 3,999 | — | — | 3,999 | ||||||||||||
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|
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| |||||||||
$ | 180,875 | $ | 95 | $ | (52 | ) | $ | 180,918 | ||||||||
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|
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Loss | Fair Value | |||||||||||||||||||||||||||||||||||||||||||||
Short-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities | $ | 49,692 | $ | 19 | $ | (3) | $ | 49,708 | ||||||||||||||||||||||||||||||||||||||||
Commercial paper | 36,431 | 12 | (3) | 36,440 | ||||||||||||||||||||||||||||||||||||||||||||
U.S. government and agency securities | 13,367 | 10 | 13,377 | |||||||||||||||||||||||||||||||||||||||||||||
Long-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities | 2,021 | 1 | 2,022 | |||||||||||||||||||||||||||||||||||||||||||||
$ | 101,511 | $ | 42 | $ | (6 | ) | $ | 101,547 | ||||||||||||||||||||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Loss | Fair Value | |||||||||||||
Current: | ||||||||||||||||
Corporate debt securities | $ | 143,254 | $ | 3 | $ | (178 | ) | $ | 143,079 | |||||||
Commercial paper | 44,001 | — | (23 | ) | 43,978 | |||||||||||
U.S. government and agency securities | 19,131 | 10 | (17 | ) | 19,124 | |||||||||||
Certificate of deposit | 4,000 | — | (3 | ) | 3,997 | |||||||||||
Non-current: | ||||||||||||||||
Corporate debt securities (one to two year maturity) | 2,007 | — | (6 | ) | 2,001 | |||||||||||
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| |||||||||
$ | 212,393 | $ | 13 | $ | (227 | ) | $ | 212,179 | ||||||||
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|
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Loss | Fair Value | |||||||||||||||||||||||||||||||||||||||||||||
Short-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities | $ | 143,254 | $ | 3 | $ | (178) | $ | 143,079 | ||||||||||||||||||||||||||||||||||||||||
Commercial paper | 44,001 | — | (23) | 43,978 | ||||||||||||||||||||||||||||||||||||||||||||
U.S. government and agency securities | 19,131 | 10 | (17) | 19,124 | ||||||||||||||||||||||||||||||||||||||||||||
Certificate of deposit | 4,000 | — | (3) | 3,997 | ||||||||||||||||||||||||||||||||||||||||||||
Long-term: | ||||||||||||||||||||||||||||||||||||||||||||||||
Corporate debt securities (one to two year maturity) | 2,007 | — | (6) | 2,001 | ||||||||||||||||||||||||||||||||||||||||||||
$ | 212,393 | $ | 13 | $ | (227 | ) | $ | 212,179 | ||||||||||||||||||||||||||||||||||||||||
The Company reviews
6.
Three Months Ended March 31, | ||||||||
2019 | 2018 | |||||||
Outstanding stock options | 10,519,696 | 8,702,552 | ||||||
Unvested restricted stock units | 949,600 | 228,100 |
The Company has
Three and Nine Months Ended September 30, | ||||||||||||||||||||||||
2019 | 2018 | |||||||||||||||||||||||
Outstanding stock options | 10,210,890 | 8,962,643 | ||||||||||||||||||||||
Unvested restricted stock units | 834,600 | 25,000 |
7.
Shares | Weighted- Average Exercise Price Per Share | Weighted- Average Remaining Contractual Term (years) | Aggregate Intrinsic Value (in thousands) | |||||||||||||
Outstanding at December 31, 2018 | 8,917,084 | $ | 13.78 | 7.4 | $ | 8,197 | ||||||||||
Granted | 2,167,700 | 8.52 | ||||||||||||||
Exercised | (28,471 | ) | 4.97 | |||||||||||||
Canceled | (536,617 | ) | 12.98 | |||||||||||||
|
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|
| |||||||||||||
Outstanding at March 31, 2019 | 10,519,696 | 12.76 | 7.5 | $ | 2,155 | |||||||||||
|
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|
|
|
| |||||||||
Exercisable at March 31, 2019 | 5,081,743 | $ | 15.02 | 5.8 | $ | 1,898 | ||||||||||
|
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|
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|
|
Shares | Weighted- Average Exercise Price Per Share | Weighted- Average Remaining Contractual Term (years) | Aggregate Intrinsic Value (in thousands) | |||||||||||||||||||||||||||||||||||||||||||||
Outstanding at December 31, 2018 | 8,917,084 | $ | 13.78 | 7.4 | $ | 8,197 | ||||||||||||||||||||||||||||||||||||||||||
Granted | 2,996,650 | 8.08 | ||||||||||||||||||||||||||||||||||||||||||||||
Exercised | (131,143 | ) | 5.55 | |||||||||||||||||||||||||||||||||||||||||||||
Canceled | (1,571,701 | ) | 13.77 | |||||||||||||||||||||||||||||||||||||||||||||
Outstanding at September 30, 2019 | 10,210,890 | 12.22 | 7.0 | $ | 12,443 | |||||||||||||||||||||||||||||||||||||||||||
Exercisable at September 30, 2019 | 5,426,297 | $ | 14.64 | 5.5 | $ | 7,869 | ||||||||||||||||||||||||||||||||||||||||||
Number of Shares Underlying RSUs | Weighted- Average Grant Date Fair Value | |||||||
Unvested at December 31, 2018 | 25,000 | $ | 9.87 | |||||
Granted | 1,019,750 | 9.20 | ||||||
Forfeited | (90,150 | ) | 9.21 | |||||
Vested | (5,000 | ) | 10.27 | |||||
|
|
|
| |||||
Unvested at March 31, 2019 | 949,600 | $ | 9.21 | |||||
|
|
|
|
Number of Shares Underlying RSUs | Weighted- Average Grant Date Fair Value | |||||||||||||||||||||||
Unvested at December 31, 2018 | 25,000 | $ | 9.87 | |||||||||||||||||||||
Granted | 1,049,900 | 9.16 | ||||||||||||||||||||||
Forfeited | (230,300 | ) | 9.24 | |||||||||||||||||||||
Vested | (10,000 | ) | 8.13 | |||||||||||||||||||||
Unvested at September 30, 2019 | 834,600 | $ | 9.18 | |||||||||||||||||||||
Separately, during the year ended December 31, 2017, the Company also granted performance-based RSUs, which vest upon the achievement of certain performance goals subject to the employee’s continued employment (“Performance-Based RSUs”).
During the three months ended March 31, 2018, the Company recognized $137 of stock-based compensation expense related to a portion of the Performance-Based RSUs when the associated performance goal became probable of achievement in the first quarter and was achieved in the second quarter of 2018. The remaining 98,800 Performance-Based RSUs were forfeited in July 2018 when the other performance goal was not achieved.
The Company has
8.
The Company is
cash.
The Company is also party to operating leases in both Munich, Germany and Tel Aviv, Israel with lease periods through January 2020 and June 2019, respectively. The remaining lease payments on such arrangements were $109, in aggregate, as
Years ended December 31, | Future Minimum Payments | |||
2019 | $ | 2,259 | ||
2020 | 3,200 | |||
2021 | 3,277 | |||
2022 | 3,447 | |||
2023 and thereafter | 10,453 | |||
|
| |||
Total minimum lease payments | $ | 22,636 | ||
Less: present value adjustment | (6,804 | ) | ||
|
| |||
Present value of minimum lease payments | $ | 15,832 | ||
|
|
follows (in thousands):
Years end ing December 31, | Future Minimum Payments | |||||||||||
2019 | $ | 793 | ||||||||||
2020 | 3,200 | |||||||||||
2021 | 3,277 | |||||||||||
2022 | 3,447 | |||||||||||
2023 and thereafter | 10,453 | |||||||||||
Total minimum lease payments | $ | 21,170 | ||||||||||
Less: present value adjustment | (5,944 | ) | ||||||||||
Present value of minimum lease payments | $ | 15,226 | ||||||||||
9.
The Company
The Company has not
10. Convertible Senior Notes
Agreement, for net proceeds of approximately $14.6 million.
(1) | during any calendar quarter commencing after the calendar quarter ending on December 31, 2018 (and only during such calendar quarter), if the last reported sale price of 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the Notes on each applicable trading day; |
(2) | during the five business day period immediately after any five consecutive trading day period (the “Measurement Period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the Measurement Period was less than 98% of the product of the last reported sale price of |
(3) | if |
(4) | upon the occurrence of specified corporate events as described within the indenture governing the Notes. |
The Company
Liability component: | ||||
Principal | $ | 172,500 | ||
Less: debt discount and issuance costs, net | (68,132 | ) | ||
|
| |||
Net carrying amount | $ | 104,368 | ||
|
| |||
Equity component: | $ | 70,059 | ||
|
|
The Company
Liability component: | ||||
Principal | $ | 172,500 | ||
Less: debt discount and issuance costs, net | (64,538 | ) | ||
Net carrying amount | $ | 107,962 | ||
Equity component: | $ | 65,641 | ||
Quarter Ended March 31, 2019 | ||||
Contractual interest expense | $ | 1,294 | ||
Amortization of debt discount | 1,623 | |||
Amortization of debt issuance costs | 81 | |||
|
| |||
Total interest expense | $ | 2,998 | ||
|
|
Nine Months Ended September 30, 2019 | ||||||||||||
Contractual interest expense | $ | 3,882 | ||||||||||
Amortization of debt discount | 5,045 | |||||||||||
Amortization of debt issuance costs | 253 | |||||||||||
Total interest expense | $ | 9,180 | ||||||||||
Years ended December 31, | Future Minimum Payments | |||
2019 | $ | 5,175 | ||
2020 | 5,175 | |||
2021 | 5,175 | |||
2022 | 5,175 | |||
2023 and thereafter | 188,025 | |||
|
| |||
Total minimum payments | $ | 208,725 | ||
Less: interest | (36,225 | ) | ||
Less: unamortized discount | (68,132 | ) | ||
Less: current portion | — | |||
|
| |||
Long term debt | $ | 104,368 | ||
|
|
Years ended December 31, | Future Minimum Payments | |||||||||||
2019 | $ | 2,588 | ||||||||||
2020 | 5,175 | |||||||||||
2021 | 5,175 | |||||||||||
2022 | 5,175 | |||||||||||
2023 and thereafter | 188,025 | |||||||||||
Total minimum payments | $ | 206,138 | ||||||||||
Less: interest | (33,638 | ) | ||||||||||
Less: unamortized discount | (64,538 | ) | ||||||||||
Less: current portion | — | |||||||||||
Convertible senior notes | $ | 107,962 | ||||||||||
Ourinitial focus ishas been on seeking the regulatory approval and commercialization of our lead drug candidate,SINE compound, selinexor,(KPT-330), as an oral agent in cancer indications with significant unmet clinical need, initiallyneed.
Following the positive outcome from the expanded cohort for the STORM study, in August 2018, we announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with a request for accelerated approval for selinexor as a new treatment for patients based on the results of the STORM study in penta-refractory multiple myeloma. Patients with penta-refractory multiple myeloma have previously received the two proteasome inhibitors (PIs), Velcade® (bortezomib) and Kyprolis® (carfilzomib), the two immunomodulatory drugs (IMiDs), Revlimid® (lenalidomide) and Pomalyst® (pomalidomide), and the anti-CD38 monoclonal antibody Darzalex® (daratumumab), as well as alkylating agents; their disease is refractory to glucocorticoids, at least one PI and at least one IMiD, Darzalex®; and their disease has progressed following their most recent therapy. The FDA previously granted orphan drug designation and fast track designation to selinexor for the treatment of patients with penta-refractory multiple myeloma. In October 2018, the FDA accepted for filing our NDA and also granted our request for priority review of the NDA and assigned an action date of April 6, 2019 under the Prescription Drug User Fee Act (PDUFA).
In February 2019, the FDA convened its Oncologic Drugs Advisory Committee (ODAC) to review data supporting our NDA requesting accelerated approval of selinexor and hold an advisory vote. The proposed indication discussed at the ODAC meeting was for selinexor in combination with dexamethasone for the treatment of patients with refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody. During the ODAC meeting, the FDA presented issues of concern, including the limitations of single arm studies, especially those involving the combination of two agents, the toxicities associated with selinexor therapy and whether the selinexor dose has been optimized. The ODAC recommended by a vote of eight to five that the FDA delay the approval of selinexor until the results of the randomized Phase 3 BOSTON study in multiple myeloma are available. We are working with the FDA as it continues to review our NDA requesting accelerated approval of selinexor. In March 2019, the FDA extended the PDUFA action date from April 6, 2019 until July 6, 2019. We submitted additional, existing clinical information as an amendment to the NDA, which allowed the FDA to extend the PDUFA action date by three months.
Provided that marketing approval is granted by the FDA, we plan to commercialize selinexor in the United States as a treatment of patients in the approved indication inmid-2019. We are completing the development of our U.S. commercial capabilities to support a potential launch of selinexor in the United States and recently hired our U.S. sales force and expanded our marketing and market access teams. We will either work with existing and potential partners to establish a commercial infrastructure outside the United States or may, in certain geographies, elect to establish the commercial infrastructure ourselves.
We also announced the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) in January 2019 with a request for conditional approval based on the results of the STORM study. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for the selinexor Marketing Authorization Application (MAA). As a customary part of the MAA review process, we received the consolidated list of questions from EMA in early May 2019 and anticipate receiving additional feedback based on routine site audits and other activities. We plan to promptly address the questions and feedback with EMA. To provide adequate time to evaluate the application and allow us to respond to questions and feedback, the EMA has switched from an accelerated review to a traditional review. We expect to receive a decision on the application by the end of 2019.
Three Months Ended March 31, |
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2019 | 2018 | $ Change | % Change | |||||||||||||
(in thousands) | ||||||||||||||||
License and other revenue | $ | 155 | $ | 10,000 | $ | (9,845 | ) | (98.5 | )% | |||||||
Operating expenses: | ||||||||||||||||
Research and development | 37,974 | 41,321 | (3,347 | ) | (8.1 | )% | ||||||||||
General and administrative | 27,103 | 7,621 | 19,482 | 255.6 | % | |||||||||||
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| |||||||||
Loss from operations | (64,922 | ) | (38,942 | ) | (25,980 | ) | 66.7 | % | ||||||||
Other income (expense), net | (1,229 | ) | 495 | (1,724 | ) | (348.3 | )% | |||||||||
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|
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| |||||||||
Loss before income taxes | (66,151 | ) | (38,447 | ) | (27,704 | ) | 72.1 | % | ||||||||
Income tax provision | (10 | ) | (12 | ) | 2 | (16.7 | )% | |||||||||
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| |||||||||
Net loss | $ | (66,161 | ) | $ | (38,459 | ) | $ | (27,702 | ) | 72.0 | % | |||||
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|
License
Three Months Ended September 30, | ||||||||||||||||||||||||||||||||||||
2019 | 2018 | $ Change | % Change | |||||||||||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||||||||||||
Product revenue, net | $ | 12,821 | $ | — | $ | 12,821 | 100 | % | ||||||||||||||||||||||||||||
License and other revenue | 328 | 239 | 89 | 37 | % | |||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||
Cost of sales | 1,013 | — | 1,013 | 100 | % | |||||||||||||||||||||||||||||||
Research and development | 26,270 | 36,427 | (10,157 | ) | (28 | )% | ||||||||||||||||||||||||||||||
Selling, general and administrative | 25,267 | 12,966 | 12,301 | 95 | % | |||||||||||||||||||||||||||||||
Loss from operations | (39,401 | ) | (49,154 | ) | 9,753 | (20 | )% | |||||||||||||||||||||||||||||
Other (expense) income, net | (1,946 | ) | 1,085 | (3,031 | ) | (279 | )% | |||||||||||||||||||||||||||||
Loss before income taxes | (41,347 | ) | (48,069 | ) | 6,722 | (14 | )% | |||||||||||||||||||||||||||||
Income tax provision | (20 | ) | (14 | ) | (6 | ) | 43 | % | ||||||||||||||||||||||||||||
Net loss | $ | (41,367 | ) | $ | (48,083 | ) | $ | 6,716 | (14 | )% | ||||||||||||||||||||||||||
the costs related to the manufacturing of XPOVIO and related materials, since, prior to FDA approval, these costs were expensed. The manufacturing costs of XPOVIO
an increase
an increase of $1.0 million in personnel costs, primarily due to increased headcount and related onboarding costs.
Nine months Ended September 30, | ||||||||||||||||||||||||||||||||||||||||||||||||
2019 | 2018 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||||||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||||||||||||||||||||||||
Product revenue, net | $ | 12,821 | $ | — | $ | 12,821 | 100 | % | ||||||||||||||||||||||||||||||||||||||||
License and other revenue | 9,976 | 30,130 | (20,154 | ) | (67 | )% | ||||||||||||||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||
Cost of sales | 1,013 | — | 1,013 | 100 | % | |||||||||||||||||||||||||||||||||||||||||||
Research and development | 90,761 | 122,482 | (31,721 | ) | (26 | )% | ||||||||||||||||||||||||||||||||||||||||||
Selling, general and administrative | 77,032 | 30,076 | 46,956 | 156 | % | |||||||||||||||||||||||||||||||||||||||||||
Loss from operations | (146,009 | ) | (122,428 | ) | (23,581 | ) | 19 | % | ||||||||||||||||||||||||||||||||||||||||
Other (expense) income, net | (4,896 | ) | 2,240 | (7,136 | ) | (319 | )% | |||||||||||||||||||||||||||||||||||||||||
Loss before income taxes | (150,905 | ) | (120,188 | ) | (30,717 | ) | 26 | % | ||||||||||||||||||||||||||||||||||||||||
Income tax provision | (38 | ) | (9 | ) | (29 | ) | 322 | % | ||||||||||||||||||||||||||||||||||||||||
Net loss | $ | (150,943 | ) | $ | (120,197 | ) | $ | (30,746 | ) | 26 | % | |||||||||||||||||||||||||||||||||||||
an increase of $2.5$5.7 million in costs related to corporate training, travel and corporate events;
an increase
We expect our general and administrative expenses to increase in 2019 to support our expanding operating and commercial activities.
this Quarterly Report on Form 10-Q. Agreement, for net proceeds of approximately $14.6 million, all of which were sold during the third quarter of 2019. (expense), net decreased from $0.5$2.2 million of other income, net for the threenine months ended March 31,September 30, 2018 to $1.2$4.9 million of other expense, net for the threenine months ended March 31,September 30, 2019. The decrease is primarily due to $3.0$9.2 million of interest expense related to the issuance of our 3.00% convertible senior notes due 2025 (Notes)the Notes in October 2018, offset by a $1.3$2.1 million increase in interest income due to increased returns resulting from a general increase in interest rates and higher investment balances.To date,have not generatedbegan generating revenues from drug sales.sales, as XPOVIO first became commercially available in the United States in July 2019. We have had limited revenues to date from product sales and have financed our operations to date principally through private placements of our preferred stock, proceeds from our initial public offering andfollow-on offerings of common stock, proceeds from the issuance of convertible debt, proceeds pursuant to the Revenue Interest Agreement (as defined below), and cash generated from our business development activities.AsMarch 31,liquidity was $269.6 million of cash, cash equivalents and investments. We have had recurring losses and incurred a loss of $150.9 million for the nine months ended September 30, 2019. Net cash used in operations for the nine months ended September 30, 2019 we had $264.4 million inwas $151.3 million. We expect that cash, cash equivalents and investments comparedat September 30, 2019 will be sufficient to $330.2fund our current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of the financial statements contained in this Quarterly Report on Formcash, cash equivalents and investments asNote 12 to the Condensed Consolidated Financial Statements included under Part I, Item 1 of December 31, 2018.“at-the-market” offering, “at the market offering”, pursuant to which we may issue and sell shares of our common stock, having an aggregate offering price of up to $75.0 million. To date there have been no sales pursuant toAs of October 31, 2019, we had sold an aggregate of 1,634,451 shares under the Open Market Sale Agreement. (FileThroughoutAt March 31, 2019, we had $264.4 million in cash, cash equivalents and investments. We have had recurring losses and incurred a loss
Three Months Ended March 31, | ||||||||
2019 | 2018 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (66,623 | ) | $ | (34,652 | ) | ||
Net cash provided by investing activities | 31,991 | 2,484 | ||||||
Net cash provided by financing activities | 152 | 429 | ||||||
Effect of exchange rate changes | (37 | ) | 43 | |||||
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Net decrease in cash, cash equivalents and restricted cash | $ | (34,517 | ) | $ | (31,696 | ) | ||
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Nine months Ended September 30, | ||||||||||||||||||
2019 | 2018 | |||||||||||||||||
(in thousands) | ||||||||||||||||||
Net cash used in operating activities | $ | (151,333 | ) | $ | (110,945 | ) | ||||||||||||
Net cash provided by (used in) investing activities | 111,969 | (4,554 | ) | |||||||||||||||
Net cash provided by financing activities | 89,369 | 148,333 | ||||||||||||||||
Effect of exchange rate changes | (26 | ) | (9 | ) | ||||||||||||||
Net increase in cash, cash equivalents and restricted cash | $ | 49,979 | $ | 32,825 | ||||||||||||||
the Revenue Interest Agreement with HCR in September 2019 and the net proceeds of $14.6 million from the sale of Open Market Shares under the Open Market Sale Agreement during the third quarter of 2019, compared to the net proceeds of $145.7 million from our follow-on offering in May 2018.
Contractual Obligations
Ascontractual obligations under the Revenue Interest Agreement with HCR, as disclosed in Note 12 to the Condensed Consolidated Financial Statements included under Part I, Item 1 of March 31, 2019, therethis Quarterly Report on Form 10-Q. There have been no other material changes to our contractual obligations described in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the 2018Form 10-K.
can provide only reasonable assurance of achieving their objectives and management necessarily applies itsour judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31,
We cannot commercialize drug candidatesXPOVIO in the United States, without first obtaining regulatoryincluding establishing and maintaining sales, marketing and distribution capabilities for XPOVIO;
organization, or collaborate with third parties, for the commercialization of selinexor, establish commercially viable pricing and obtain approval for adequate reimbursement from third-party and government payors. If we or our commercialization collaborators are unablean inability to successfully commercialize selinexor, we may not be able to generate sufficient revenues to continueXPOVIO or our drug candidates, which would materially harm our business.
We currently have no drugs approved for sale and we cannot guarantee that we will ever have marketable drugs.
five that the FDA delay the approval of selinexor until the results of the randomized Phase 3 BOSTON study in multiple myeloma are available. In March 2019, the FDA extended the PDUFA action date from April 6, 2019 until July 6, 2019. We submitted additional, existing clinical information as an amendment to the NDA, which allowed the FDA to extend the PDUFA action date by three months. We or our current or future partners may also seek such approvals in other geographies. We cannot be certain that we will commence additional later phase trials or complete ongoing later phase trials as anticipated. Before obtaining regulatory approvals for the commercial sale of any drug candidate for a target indication, we must demonstrate with substantial evidence gathered in preclinical studies and well-controlled clinical studies, and, with respect to approval in the United States, to the satisfaction of the FDA, that the drug candidate is safe and effective for use for that target indication. There is no assurance that the FDA or
We are early With respect to the STORM and SADAL studies, the FDA has reiterated to us that it recommends, in our development effortsgeneral, a randomized trial with a limited number of drug candidates in human clinical development. If we are unable to successfully develop and commercialize our drug candidates or experience significant delays in doing so, our business will be materially harmed.
We are early in our development efforts and have four drug candidates, selinexor, verdinexor, eltanexor andKPT-9274, in clinical development for treatment of human diseases. The success of these and any of our other drug candidates will depend on several factors, including the following:
successful completion of preclinical studies;
acceptance by the FDA of investigational new drug applications, or INDs, for our drug candidates prior to commencing clinical studies;
successful enrollment in, and completion of, clinical trials, including demonstration of a favorable risk-benefit ratio;
receipt of marketing approvals from applicable regulatory authorities;
establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our drug candidates;
establishing sales, marketing, manufacturing and distribution capabilities to commercialize any drugs for which we may obtain marketing approval, whether alone or in collaboration with others;
launching commercial sales of the drugs, if and when approved, whether alone or in collaboration with others;
acceptance of the drugs, if and when approved, by patients, the medical community and third-party payors;
effectively competing with other therapies;
obtaining and maintaining coverage, adequate pricing and adequate reimbursement by third-party payors, including government payors, for any approved drugs;
maintaining an acceptable safety profile of the drugs following approval;
enforcing and defending intellectual property rights and claims; and
maintaining and growing an organization of scientists and business people, including collaborators, who can develop and commercialize our drug candidates.
If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates, which would materially harm our business.
Our approach to the discovery and development of drug candidates that target Exportin 1, or XPO1, is unproven, and we do not know whether we will be able to develop any drugs of commercial value. If selinexor is unsuccessful in proving that drug candidates targeting XPO1 have commercial value or experiences significant delays in doing so, our business may be materially harmed.
Our SINE compounds inhibit the nuclear export protein XPO1. We believe that no currently approved cancer treatments are selectively targeting the restoration and increase in the levels of multiple tumor suppressor proteins in the nucleus. Despite promising results to date in preclinical studies of selinexor that we have conducted and in Phase 1 and Phase 2 clinical trials of selinexor conducted by us or our academic collaborators, we may not succeed in demonstrating safety and efficacy of SINE compounds in our current and future human clinical trials. Any drug candidates that we develop may not effectively prevent the exportation of tumor suppressor and/or growth regulatory proteins from the nucleus in humans with a particular form of cancer. If selinexor is unsuccessful in supporting the hypothesis that drug candidates targeting the regulation of intracellular transport of XPO1 have commercial value or experiences significant delays in doing so, our business may be materially harmed and we may not be able to generate sufficient revenues to continue our business.
We may not be successful in our efforts to identify or discover additional potential drug candidates.
data provided by our clinical trial investigators. An audit of this data may change the conclusions drawn from this unaudited data provided by our clinical trial investigators indicating less promising results than we currently anticipate. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their drug candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs.drug candidates. Furthermore, the failure of any drug candidates to demonstrate safety and efficacy in any clinical trial could negatively impact the perception of our other drug candidates and/or cause the FDA or other regulatory authorities to require additional testing before any of our drug candidates are approved.
Even if
If
and distribution infrastructure to market orare currently establishingintend to work with existing and potential partners to establish the commercial infrastructure to support a potential launch of selinexor in the United States, and we intend to work with existing and potential partners to establish such commercial infrastructure outside the United States.
candidates for which we obtain marketing approval.
establishedwell-established therapies and are widely accepted by physicians, patients and third-party payors. Insurers and other third-party payors may also encourage the use of generic drugs. We expect that ifany of our drug candidates that are approved they will be priced at a significant premium over competitive generic drugs. This may make it difficult for us to achieve our business strategy of using our drug candidates in combination with existing therapies or replacing existing therapies with our drug candidates.
Significant uncertainty exists as
establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval, prior to or upon receiving marketing approval;
To
achieving an adequate level of market acceptance and obtaining and maintaining coverage and adequate reimbursement from third-party payors for any drugs we commercialize; and
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our drug candidates.
Until such time, if ever, ascandidates for which we can generate substantial revenues from the sale of drugs, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through further collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, research programs or drug candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our research and drug development or commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.
obtain marketing approval.
plans and our business could be adversely affected.
ultimately for commercialization.commercialization of any drug candidates that we develop and commercialize. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
If any of our drug candidates are approved by any regulatory agency, we intend to enter into agreements with
Prior to seeking such accelerated approval, we will continue to seek feedback from the FDA and otherwise evaluate our ability to seek and receive such accelerated approval.
Similarly, we intend to use the data from the SADAL study to support an NDA request that the FDA consider granting accelerated approval for selinexor in relapsed and/or refractory diffuse largehas agreed that the current trial design and indication appear appropriate for accelerated approval, they reiterated to us in their feedback that the availability of accelerated approval will depend on the trial results and available therapies at the time of regulatory action. The FDA also has reiterated to us that it recommends, in general, a randomized trial with a progression-free survival endpoint as an initial registration approach and, for DLBCL, recommended two randomized trials that isolate the treatment effect of selinexor for a DLBCL indication. In addition, as we experienced with our NDA based on the results of Part 2 of the STORM study, the FDA has noted tolerability and dose optimization as review matters. Although we believe that our SADAL study presents an opportunity for us to request that the FDA grant accelerated approval for selinexor in relapsed and/or refractory DLBCL, there can be no assurance that the FDA will grant such approval, whether on an accelerated basis, or at all.
Moreover, for drugs granted accelerated approval, the FDA typically requires post-marketing confirmatory trials to evaluate the anticipated effect on irreversible morbidity or mortality or other clinical benefit. These confirmatory trials must be completed with due diligence. The FDA may withdraw approval of a product candidate approved under the accelerated approval pathway if, for example, the trial required to verify the predicted clinical benefit of our product candidate fails to verify such benefit or does not demonstrate sufficient clinical benefit to justify the risks associated with the drug. The FDA may also withdraw approval if other evidence demonstrates that our product candidate is not shown to be safe or effective under the conditions of use, we fail to conduct any required post approval trial of our product candidate with due diligence or we disseminate false or misleading promotional materials relating to our product candidate. Similar risks to those described above are also applicable to any application that we have submitted or may submit to the EMA to support conditional approval of selinexor to treat penta-refractory multiple myeloma, relapsed/refractory DLBCL, or any other cancer indication.
for orphan drug designation or if the product is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition.
Any
Any
The FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a drug. The FDA and other agencies, including the Department of Justice, or the DOJ, closely regulate and monitor the post-approval marketing and promotion of drugs to ensure that they are manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding
In addition, later discovery of previously unknown AEs or other problems with our drugs or their manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:
review submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. In January 2017, President Trump issued an executive order, applicable to all executive agencies including the FDA, which requires that for each notice of proposed rulemaking or final regulation to be issued in fiscal year 2017, the agency shall identify at least two existing regulations to be repealed, unless prohibited by law. These requirements are referred to as the
otherwise affect the prices we may obtain for XPOVIO and for any of our product candidates for which we may obtain regulatory approval or the frequency with which XPOVIO or any such product candidate is prescribed or used. Further, there have been several recent U.S. congressional inquiries and proposed state and federal legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.
On July 10, 2019, the Court of Appeals for the Fifth Circuit heard oral argument in this case. In those arguments, the Trump Administration argued in support of upholding the lower court decision. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results.
greater. The GDPR greater, and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages.damages resulting from violations of the GDPR. In addition, the GDPR provides that European Union member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data.
reputation and our business.
our success in launching and commercializing XPOVIO;
We could be subject to securities class action litigation.
operations.
Exhibit Number | Form | Incorporated by Reference | Provided Herewith | |||||||||||||||||||||
Description of Exhibit | File Number | Date of Filing | Exhibit Number | |||||||||||||||||||||
10.1 | 8-K | 001-36167 | August 6, 2019 | 10.1 | ||||||||||||||||||||
10.2* | X | |||||||||||||||||||||||
31.1 | X | |||||||||||||||||||||||
31.2 | X | |||||||||||||||||||||||
32.1 | X | |||||||||||||||||||||||
32.2 | X | |||||||||||||||||||||||
101.INS | Inline XBRL Instance Document | The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document | ||||||||||||||||||||||
101.SCH | Inline XBRL Schema Document | X | ||||||||||||||||||||||
101.CAL | Inline XBRL Calculation Linkbase Document | X | ||||||||||||||||||||||
101.DEF | Inline XBRL Definition Linkbase Document | X | ||||||||||||||||||||||
101.LAB | Inline XBRL Label Linkbase Document | X | ||||||||||||||||||||||
101.PRE | Inline XBRL Presentation Linkbase Document | X | ||||||||||||||||||||||
104 | Cover Page Interactive Data File | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) |
KARYOPHARM THERAPEUTICS INC. | ||||||
Date: November 4, 2019 | By: | /s/ MICHAEL KAUFFMAN | ||||
Michael Kauffman, M.D., Ph.D. | ||||||
Chief Executive Officer | ||||||
(Principal executive officer) | ||||||
Date: November 4, 2019 | By: | /s/ MICHAEL MASON | ||||
Michael Mason | ||||||
Senior Vice President, Chief Financial Officer and Treasurer | ||||||
(Principal financial and accounting officer) |
72