☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
2019
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(617) (§ ☐ ☒Non-accelerated filer ☐ ☒ ☒November 2, 2018,October 29, 2019, there were 60,707,87662,790,043 shares of Common Stock, $0.0001 par value per share, outstanding.
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Item 1.A. | 37 | |||||
Item 6. | 78 | |||||
79 |
Item 1. | Condensed Consolidated Financial Statements (Unaudited). |
September 30, 2018 | December 31, 2017 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 101,600 | $ | 68,997 | ||||
Short-term investments | 105,170 | 77,472 | ||||||
Prepaid expenses and other current assets | 4,792 | 1,754 | ||||||
Restricted cash | — | 200 | ||||||
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Total current assets | 211,562 | 148,423 | ||||||
Property and equipment, net | 2,914 | 2,185 | ||||||
Long-term investments | 4,804 | 29,396 | ||||||
Restricted cash | 712 | 290 | ||||||
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Total assets | $ | 219,992 | $ | 180,294 | ||||
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Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,238 | $ | 5,665 | ||||
Accrued expenses | 29,155 | 21,445 | ||||||
Deferred revenue | 9,362 | 21,921 | ||||||
Deferred rent | 256 | 303 | ||||||
Other current liabilities | 556 | 133 | ||||||
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Total current liabilities | 41,567 | 49,467 | ||||||
Deferred revenue, net of current portion | 4,532 | — | ||||||
Deferred rent, net of current portion | 2,815 | 1,363 | ||||||
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Total liabilities | 48,914 | 50,830 | ||||||
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; 60,664,857 and 49,533,150 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 6 | 5 | ||||||
Additionalpaid-in capital | 786,763 | 625,017 | ||||||
Accumulated other comprehensive loss | (153 | ) | (217 | ) | ||||
Accumulated deficit | (615,538 | ) | (495,341 | ) | ||||
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Total stockholders’ equity | 171,078 | 129,464 | ||||||
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Total liabilities and stockholders’ equity | $ | 219,992 | $ | 180,294 | ||||
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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, September 30, | Nine Months Ended September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
License and other revenue | $ | 239 | $ | — | $ | 30,130 | $ | 71 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 36,427 | 25,237 | 122,482 | 72,440 | ||||||||||||
General and administrative | 12,966 | 5,818 | 30,076 | 18,717 | ||||||||||||
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Total operating expenses | 49,393 | 31,055 | 152,558 | 91,157 | ||||||||||||
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Loss from operations | (49,154 | ) | (31,055 | ) | (122,428 | ) | (91,086 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 1,098 | 454 | 2,260 | 1,266 | ||||||||||||
Other expense | (13 | ) | (26 | ) | (20 | ) | (70 | ) | ||||||||
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Total other income, net | 1,085 | 428 | 2,240 | 1,196 | ||||||||||||
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Loss before income taxes | (48,069 | ) | (30,627 | ) | (120,188 | ) | (89,890 | ) | ||||||||
Income tax provision | (14 | ) | (13 | ) | (9 | ) | (54 | ) | ||||||||
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Net loss | $ | (48,083 | ) | $ | (30,640 | ) | $ | (120,197 | ) | $ | (89,944 | ) | ||||
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Net loss per share—basic and diluted | $ | (0.79 | ) | $ | (0.65 | ) | $ | (2.17 | ) | $ | (2.00 | ) | ||||
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Weighted-average number of common shares outstanding used in net loss per share—basic and diluted | 60,586,511 | 47,141,146 | 55,465,261 | 44,974,945 | ||||||||||||
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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 September 30, | Nine Months Ended September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Net loss | $ | (48,083 | ) | $ | (30,640 | ) | $ | (120,197 | ) | $ | (89,944 | ) | ||||
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Comprehensive income | ||||||||||||||||
Unrealized gain on investments | 110 | 25 | 105 | 50 | ||||||||||||
Foreign currency translation adjustments | (3 | ) | 50 | (41 | ) | 134 | ||||||||||
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Comprehensive loss | $ | (47,976 | ) | $ | (30,565 | ) | $ | (120,133 | ) | $ | (89,760 | ) | ||||
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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 | ) | ||||||||||||||||||||
Nine Months Ended September 30, | ||||||||
2018 | 2017 | |||||||
Operating activities | ||||||||
Net loss | $ | (120,197 | ) | $ | (89,944 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 541 | 539 | ||||||
Net amortization of premiums and discounts on investments | 280 | 903 | ||||||
Stock-based compensation expense | 13,378 | 15,906 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | (3,039 | ) | 18 | |||||
Accounts payable | (3,425 | ) | (2,867 | ) | ||||
Accrued expenses and other liabilities | 8,139 | 6,423 | ||||||
Deferred revenue | (8,027 | ) | 1,050 | |||||
Deferred rent | 1,405 | (207 | ) | |||||
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Net cash used in operating activities | (110,945 | ) | (68,179 | ) | ||||
Investing activities | ||||||||
Purchases of property and equipment | (1,270 | ) | (7 | ) | ||||
Proceeds from maturities of investments | 94,378 | 94,033 | ||||||
Purchases of investments | (97,662 | ) | (74,017 | ) | ||||
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Net cash (used in) provided by investing activities | (4,554 | ) | 20,009 | |||||
Financing activities | ||||||||
Proceeds from the issuance of common stock, net of issuance costs | 145,706 | 52,323 | ||||||
Proceeds from the exercise of stock options and shares issued under employee stock purchase plan | 2,627 | 463 | ||||||
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Net cash provided by financing activities | 148,333 | 52,786 | ||||||
Effect of exchange rate on cash, cash equivalents and restricted cash | (9 | ) | 181 | |||||
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Net increase in cash, cash equivalents and restricted cash | 32,825 | 4,797 | ||||||
Cash, cash equivalents and restricted cash at beginning of period | 69,487 | 50,142 | ||||||
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Cash, cash equivalents and restricted cash at end of period | $ | 102,312 | $ | 54,939 | ||||
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Reconciliation of cash, cash equivalents and restricted cash reported within the condensed | ||||||||
Cash and cash equivalents | $ | 101,600 | $ | 54,450 | ||||
Short-term restricted cash | — | 200 | ||||||
Long-term restricted cash | 712 | 289 | ||||||
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Total cash, cash equivalents and restricted cash | $ | 102,312 | $ | 54,939 | ||||
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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 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 September 30, 2018,February 28, 2019.
States in July 2019.
in Note 2. There were no changes to our accounting policy for license and asset sale agreements, as disclosed in our
The Company
contract and determinesdetermine those that are performance obligations and assesses whether each promised good or service is distinct. The CompanyWe then recognizesrecognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
The Company generates revenue from license
If a licenserespect to the Company’s intellectual propertypurchase of our products.
The Company utilizes judgment to determine the transaction price. In connection therewith, the Company evaluates contingent milestones at contract inception to estimate the amount which is not probable of a material reversal to include in the transaction price using the most likely amount method. Milestone payments that are not within theobtains control of the Company, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, forour product, which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, the Companyre-evaluates the probability of achieving development milestone payments which may not be subject to a material reversal and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulativecatch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment.
The Company then determines whether the performance obligations or combined performance obligations are satisfied over time oroccurs at a point in time, generally upon delivery pursuant to our agreements with our customers. If taxes should be collected from customers relating to product sales and if overremitted to governmental authorities, they will be excluded from revenue.
When consideration is received, or such consideration is unconditionally due, fromrecognized, resulting in a customer prior to transferring goods or servicesreduction of product revenue and accounts receivable. We generally issue credits to the customer for such amounts within a few weeks after the customer notifies us of the resale to a discount-eligible healthcare entity.
For arrangements that include sales-based royalties, including sales-based milestone payments,development expense in the period incurred. We capitalize the costs to manufacture our products incurred after regulatory approval when, based on our judgment, future commercialization is considered probable and a license of intellectual propertythe future economic benefit is deemedexpected to be the predominant item to which the royalties relate, the Company recognizes revenuerealized. Such costs are generally recorded as costs of sales upon shipment. In connection therewith, we value our inventories at the laterlower of whencost or estimated net realizable value. We determine the cost of our inventories, which includes amounts related to materials and manufacturing overhead, on a
obligation, and record interest expense using
As
In August 2016,effective date. The difference between the Financial Accounting Standards Boards (“FASB”) issuedASU 2016-15, Classificationoperating leaseCertain Cash Receiptsdeferred rent and Cash Payments(“ASU 2016-15”). Thislease incentives through December 31, 2018 from liabilities to a reduction in our operating lease
In October 2016, the FASB issuedASU No. 2016-16,Accounting for Income Taxes: Intra-Entity Asset Transfers of Assets Other than Inventory (Topic 740). Topic 740 eliminates the ability to defer the tax expense related to intra-entity asset transfers other than inventory. Under this standard, entities recognize the income tax consequences on an intra-entity transfer of an asset other than inventory when the transfer occurs. The Company adopted Topic 740 effective January 1, 2018 and the adoption did not have a material impact on the Company’s financial position or results of operations.
In November 2016, the FASB issuedASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. This standard requires that aour condensed consolidated statement of cash flows explain the change during the period in the total of cash, cash equivalentsoperations and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling thebeginning-of-period andend-of-period total amounts shown on the statement of cash flows. The Company adopted this standard effective January 1, 2018 and reclassified restricted cash in the statements of cash flows to be included in the cash and cash equivalents balance. The standard resulted in the reclassification of $490 and $479 into cash, cash equivalents and restricted cash within the beginning of period balance on the condensed consolidated statements of cash flowscomprehensive loss for the nine-month periods ended September 30, 2018three and 2017, respectively. This adoption also resulted in an immaterial adjustment to the effect of exchange rate on cash, cash equivalents and restricted cash during the nine-month period ended September 30, 2017.
In May 2017, the FASB issuedASU 2017-09,Compensation-Stock Compensation (Topic 718)(“ASU 2017-09”)Scope of Modification Accounting.ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considerednon-substantive. The Company adopted this standard effective January 1, 2018 and the adoption did not have a material impact on the Company’s consolidated financial statements.
On December 22, 2017, the Tax Cuts and Jobs Act (“TCJA”) was enacted and led to significant changes to U.S. tax law. Also on December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), allowing companies to record the effects of the TCJA on a provisional basis during a measurement period not to extend beyond one year of the enactment date. SAB 118 was codified into ASC 740 byASU 2018-05. The Company recorded a reduction to its deferred tax asset for $42,763 and a corresponding reduction to its valuation allowance related to implementing applicable provisions of the TCJA during the year ended December 31, 2017. During the nine months ended September 30, 2018, there was no further information or change in estimates related to the provisional amount recognized during the year ended December 31, 2017.
Recently Issued Accounting Standards
On August 17, 2018, the SEC issued an amendment toRule 3-04 ofRegulation S-X, which extended the annual disclosure requirement of reporting changes in stockholders’ equity to interim periods. Such disclosures are2019, as expense for our existing operating leases continues to be provided in a note torecognized consistent with the financial statements or in a separate financial statement and requires both theyear-to-date information and subtotals for each interim period. On September 25, 2018, the SEC issued guidance under a Compliance and Disclosure Interpretation (C&DI 105.09) to clarify the effective daterecognition pattern before adoption of the requirement. Undernew standard. Please refer to Note 10, “Leases” for further information.
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 right-of-use assets, offset by reclassification of deferred rent and tenant incentives to operating leaseright-of-use assets. |
(2) | Represents reclassification of deferred rent and tenant incentives to operating lease right-of-use assets. |
(3) | Represents recognition of operating lease liabilities. |
preparation of financial information upon adoption.
In February 2016, the FASB issuedASU No. 2016-02, Leases (Topic 842). The new standard requires that all lessees recognize the assets and liabilities that arise from leases on the balance sheet and disclose qualitative and quantitative information about its leasing arrangements. The new standard will be effective for the Company on January 1, 2019. In July 2018, the FASB issuedASU 2018-11,Leases (Topic 842) TargetedImprovements, that gives entities the option to not provide comparative period financial statements and instead apply the transition requirements as of the effective date of the new standard. The Company plans to adopt the new standard using this optional method.
Pursuant to the guidance underASU No. 2016-02, the Company also plans to elect the optional package of practical expedients, which will allow the Company to not reassess: (i) whether expired or existing contracts contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The new standard also allows entities to make certain
policy elections, some of which the Company also plans to elect, including: (i) a policy to not record short-term leases on the balance sheet and (ii) a policy to not separate lease andnon-lease components. The Company is currently working through lease contract scoping, design and implementation of transition related controls, and finalization of accounting elections. The Company is still assessing the impact this standard will have on its consolidated financial statements and disclosures; however, it anticipates that the new standard will result in the Company recording additional right of use assets and corresponding liabilities on its consolidated balance sheet.
In July 2018, the FASB issued ASUNo.Improvements. Improvementsmajority of the amendments in ASUNo. 2018-09 will beare effective for the Company in annual periods beginning after December 15, 2018.2018 and were adopted effective January 1, 2019. The Companyadoption of these amendments did not have a material impact on our condensed consolidated financial statements.
related disclosures.
3.discounts, as well as reserves for chargebacks, rebates and returns.
September 30, 2019 | December 31, 2018 | |||||||||||||||||
Raw materials and work in process | $ | — | $ | — | ||||||||||||||
Finished goods | 100 | — | ||||||||||||||||
Total inventory | $ | 100 | $ | — | ||||||||||||||
The Company
The Company
Upon execution of the Antengene License Agreement, the only fixed component of the transaction price included the $11,703$11.7 millionthe Company.us. As referenced above, the Company iswe are eligible to receive additional payments of up to $105,000$105.0 million in milestone payments if certain development goals are achieved and up to $45,000$45.0 million in milestone payments if certain sales milestones are achieved, as well as a high single-digit to low double-digit royalty on future net sales of the Antengene Licensed Compounds in the Antengene Territory. In addition, the Companywe would receive cost reimbursement in connection with Antengene’s election to receive additional clinical supply for the Antengene Licensed Compounds in the future. The future regulatory milestones and cost reimbursement for providing additional clinical supply of the Antengene Licensed Compounds, both of which represent variable consideration, were evaluated under the most likely amount method, and were not included in the transaction price at contract inception and/or through September 30, 2018,2019, because the amounts were fully constrained as of September 30, 2018.2019. 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 Antengene, will be recognized when the related sales occur, as they were determined to relate predominantly to the intellectual property licenses granted to Antengene 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 Company
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 Company We further determined that the$10,000$10.0 million constituted the entirety of the consideration to be 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.
During the nine months ended September 30, 2018, the Company
goods.
The Ono License Agreement will continue in effect on athe Companyus in the event Ono challenges or assists with a challenge to certain of the Company’sour patent rights.
The Company
The Company
September 30, 2018.2019. 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
Given the determination that the license rights conveyed to Ono lacked standalone value from the initial clinical supply of product required for Ono to obtain benefit from the rights granted and the fact that no initial clinical supply had been provided to Ono as of December 31, 2017, the Company concluded that no revenue should be recognized under ASC 605. Arrangement consideration at the inception of the arrangement included the ¥2.5 billion (US$21,916 on the date received) upfront payment. All other forms of consideration such as milestones and royalties, were considered contingent consideration, with no amount allocable to deliverables at the inception of the arrangement. The Company concluded that the contingent consideration would be recognized when the underlying contingencies have been resolved, assuming all other revenue recognition criteria are met. As the accounting treatment for this agreement did not materially differ under ASC 605 and ASC 606, and no revenue was recognized under the Company’s previous accounting policy through December 31, 2017, no transition adjustment was recorded to the opening balance of accumulated deficit as of January 1, 2018. Accordingly, the upfront payment of ¥2.5 billion (US$21,916 on the date received), which represents a contract liability, was also included in deferred revenue as of December 31, 2017.
MMRF Research Agreement
The Company is a party to a research agreement with the Multiple Myeloma Research Foundation (“MMRF”). Under this research agreement, the Company is obligated to make certain payments to MMRF, including if the Companyout-licenses selinexor. The terms of this research agreement do not apply to eltanexor,KPT-9274 or verdinexor. During the quarter ended September 30, 2018, the Company paid approximately $278 to MMRF, which reflects the amount owed to MMRF under the Antengene License Agreement transaction. In connection with the transaction pursuant to the Ono License Agreement, the Company paid to MMRF $1,972 of the upfront cash payment from Ono in the year ended December 31, 2017. The Company will be obligated to pay a percentage of any milestone payments from Antengene and Ono and amid-single-digit percentage of any royalty payments from Antengene and Ono. Such payments are recorded within research and development expense in the Company’s condensed consolidated statement of operations. As of September 30, 2018, a maximum of $3,750 in potential future obligations to MMRF are remaining under the MMRF research agreement.
The Company
The Company
The Company reached similar conclusions when evaluating this agreement under its previous accounting policy, which was based on legacy guidance within ASC 605. When evaluating this agreement under ASC 605, the Company concluded that the licenses to verdinexor and technology transfer concerning the licensed product are essential to Anivive’s intended use of the license to develop and commercialize the licensed compound and represented a single unit of accounting. Other potential contractual obligations were evaluated and determined not to be deliverables at inception of the arrangement or were evaluated and determined to be immaterial to the arrangement and, therefore, not evaluated further in the Company’s analysis. Arrangement consideration at the inception of the arrangement included the $1,250 in upfront payments, which includes the milestone fee upon completion of the technology transfer. All other forms of consideration, such as milestones and royalties, were considered contingent consideration, with no amount allocable to deliverables at the inception of the arrangement. The Company concluded that the contingent consideration would be recognized when the underlying contingencies have been resolved, assuming all other revenue recognition criteria are met. Given the single unit of accounting and that the technology transfer would be the last item to be delivered within the unit of accounting, the Company concluded that revenue would be recognized upon the completion of delivery of the technology transfer assuming all other general revenue recognition criteria would be met as of that date. As the accounting treatment for this agreement did not materially differ under ASC 605 and ASC 606, and the upfront payment and technology transfer fee, totaling $1,250, was recognized as revenue during the year ended December 31, 2017 in accordance with the Company’s previous accounting policy, and would have also been recognized during the year ended December 31, 2017 in accordance with the Company’s accounting policy under ASC 606, no transition adjustment was recorded to the opening balance of accumulated deficit as of January 1, 2018.
4.
The Company is2018.
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 | $ | 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 | $ | 70,876 | $ | 70,876 | $ | — | $ | — | ||||||||
Investments: | ||||||||||||||||
Current: | ||||||||||||||||
Corporate debt securities | 87,205 | — | 87,205 | — | ||||||||||||
Commercial paper | 8,988 | — | 8,988 | — | ||||||||||||
U.S. government and agency securities | 2,477 | — | 2,477 | — | ||||||||||||
Certificates of deposit | 6,500 | — | 6,500 | — | ||||||||||||
Non-current: | ||||||||||||||||
Corporate debt securities (one to two year maturity) | 4,804 | — | 4,804 | — | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
$ | 180,850 | $ | 70,876 | $ | 109,974 | $ | — | |||||||||
|
|
|
|
|
|
|
|
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 | $ | — | |||||||||||||||||||||||||||||||||||||||||
The following table presents information about the Company’s financial assets that have been measured at fair value at December 31, 2017 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands):
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 | $ | 41,805 | $ | 41,805 | $ | — | $ | — | ||||||||
Investments: | ||||||||||||||||
Current: | ||||||||||||||||
Corporate debt securities | 66,253 | — | 66,253 | — | ||||||||||||
Commercial paper | 6,720 | — | 6,720 | — | ||||||||||||
Certificates of deposit | 2,500 | — | 2,500 | — | ||||||||||||
U.S. government and agency securities | 1,999 | — | 1,999 | — | ||||||||||||
Non-current: | — | |||||||||||||||
Corporate debt securities (one to two year maturity) | 26,916 | — | 26,916 | — | ||||||||||||
U.S. government securities and agency securities | 2,480 | — | 2,480 | — | ||||||||||||
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| |||||||||
$ | 148,673 | $ | 41,805 | $ | 106,868 | $ | — | |||||||||
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|
5.
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Loss | Fair Value | |||||||||||||
Current: | ||||||||||||||||
Corporate debt securities | $ | 87,317 | $ | 6 | $ | (118 | ) | $ | 87,205 | |||||||
Commercial paper | 8,988 | — | — | 8,988 | ||||||||||||
U.S. government and agency securities | 2,500 | — | (23 | ) | 2,477 | |||||||||||
Certificates of deposit | 6,500 | — | — | 6,500 | ||||||||||||
Non-current: | ||||||||||||||||
Corporate debt securities (one to two year maturity) | 4,817 | — | (13 | ) | 4,804 | |||||||||||
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| |||||||||
$ | 110,122 | $ | 6 | $ | (154 | ) | $ | 109,974 | ||||||||
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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 | $ | 66,384 | $ | — | $ | (131 | ) | $ | 66,253 | |||||||
Commercial paper | 6,719 | 1 | — | 6,720 | ||||||||||||
Certificates of deposit | 2,500 | — | — | 2,500 | ||||||||||||
U.S. government and agency securities | 2,000 | — | (1 | ) | 1,999 | |||||||||||
Non-current: | ||||||||||||||||
Corporate debt securities (one to two year maturity) | 27,018 | 2 | (104 | ) | 26,916 | |||||||||||
U.S. government and agency securities | 2,500 | — | (20 | ) | 2,480 | |||||||||||
|
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| |||||||||
$ | 107,121 | $ | 3 | $ | (256 | ) | $ | 106,868 | ||||||||
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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. Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
Estimated Useful Life Years | September 30, 2018 | December 31, 2017 | ||||||||||
Laboratory equipment | 4 | $ | 593 | $ | 593 | |||||||
Furniture and fixtures | 5 | 601 | 381 | |||||||||
Office and computer equipment | 3 | 408 | 378 | |||||||||
Construction in process | N/A | 491 | — | |||||||||
Leasehold improvements | | Lesser of useful life or lease term |
| 3,920 | 3,391 | |||||||
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| |||||||||
6,013 | 4,743 | |||||||||||
Less accumulated depreciation and amortization | (3,099 | ) | (2,558 | ) | ||||||||
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| |||||||||
$ | 2,914 | $ | 2,185 | |||||||||
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|
7. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
September 30, 2018 | December 31, 2017 | |||||||
Research and development costs | $ | 18,118 | $ | 16,198 | ||||
Payroll and employee-related costs | 7,349 | 3,982 | ||||||
Professional fees | 3,443 | 972 | ||||||
Other | 245 | 293 | ||||||
|
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|
| |||||
$ | 29,155 | $ | 21,445 | |||||
|
|
|
|
Three and Nine Months Ended September 30, | ||||||||
2018 | 2017 | |||||||
Outstanding stock options | 8,962,643 | 7,049,007 | ||||||
Unvested restricted stock units | 25,000 | 425,850 |
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 |
Shares | Weighted- Average Exercise Price Per Share | Weighted- Average Remaining Contractual Term (years) | Aggregate Intrinsic Value (in thousands) | |||||||||||||
Outstanding at December 31, 2017 | 7,019,083 | $ | 13.77 | 7.4 | $ | 11,897 | ||||||||||
Granted | 3,232,350 | $13.11 | ||||||||||||||
Exercised | (458,989 | ) | $4.91 | |||||||||||||
Canceled | (829,801 | ) | $ | 15.12 | ||||||||||||
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| |||||||||||||
Outstanding at September 30, 2018 | 8,962,643 | $ | 13.86 | 7.5 | $ | 50,973 | ||||||||||
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| |||||||||
Exercisable at September 30, 2018 | 4,329,028 | $ | 15.52 | 6.0 | $ | 27,085 | ||||||||||
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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 | ||||||||||||||||||||||||||||||||||||||||||
During the year ended December 31, 2017, the Company granted We grant RSUs with service conditions that vest in 2 or 4 equal annual installments provided that the employee remains employed with the Companyus (“Time-Based RSUs”).
Number of Shares Underlying RSUs | Weighted- Average Grant Date Fair Value | |||||||
Unvested at December 31, 2017 | 30,000 | $ | 10.52 | |||||
Granted | — | — | ||||||
Forfeited | — | — | ||||||
Vested | (5,000 | ) | 10.27 | |||||
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|
| |||||
Unvested at September 30, 2018 | 25,000 | $ | 10.57 | |||||
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|
|
2019:
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, and during the year ended December 31, 2017, the Company 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 nine months ended September 30, 2018, the Company recognized $180 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. The remaining 98,800 Performance-Based RSUs were forfeited in July 2018 when the performance goal was not achieved.
The Company has
approved the reservation of 242,424 shares of the Company’sour common stock for issuance under the ESPP, plus an annual increase to be added on the first day of each fiscal year, commencing on January 1, 2015 and ending on December 31, 2023, equal to the lesser of 484,848 shares of the Company’sour common stock, 1% of the number of outstanding shares on such date, or an amount determined by the board of directors.
10. Commitments and Contingencies
In 2014, the Company entered into an operating lease and subsequent amendment to lease approximately 46,167of 98,502 square feet of office and research space in Newton, Massachusetts with a term through September 30, 2022. The lease provided2025 (the “Newton, MA Lease”). Pursuant to the Company with an allowance for improvements of $1,616 which was incurred in the first quarter of 2015. In February 2018, the lease was amended to extend the term of the lease to September 30, 2025 and expand the leased premises to approximately 62,143 square feet. In June 2018, the lease was further amended to expand the premise to a total of approximately 98,502 square feet with no change in lease term. The 2018 lease amendments provided the Company with an allowance for improvements of $2,131, of which $1,014 was incurred during the nine months ended September 30, 2018.
The Company evaluated the lease amendments and determined that the classification of the lease as an operating lease had not changed, and that the amendments did not constitute a new lease. As such, the unamortized balances of the existing deferred rent and tenant improvement allowances, along with the additions to deferred rent and tenant improvement allowances, will be amortized through September 30, 2025. All improvements were deemed normal tenant improvements, were recorded as leasehold improvements and deferred rent and will be recorded as a reduction to rent expense ratably over the lease term. The Company is recording rent expense on a straight-line basis through the end of the lease term, inclusive of the period in which there are no scheduled rent payments. The Company has recorded deferred rent on the condensed consolidated balance sheets at September 30, 2018 and December 31, 2017, accordingly. Finally, the Company hasNewton, MA Lease, we have provided a security deposit in the form of a cash-collateralized letter of credit in the amount of $550.$0.6 million. The amount is classified withinnon-current restricted cashcash.
In November 2014,Newton, MA Lease in arriving at the Company signed a five-year
The Company recorded rent expense totaling $895 and $296 for the three months ended September 30, 2018 and 2017, respectively, and $1,700 and $894Newton, MA Lease for the nine months ended September 30, 20182019 was $2.1 million, of which approximately $0.7 million was charges for CAM.
do not record a related
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 | ||||||||||
On April 28, 2017, the Company completed afollow-on offering under its shelf registration statement onForm S-3 (FileNo. 333-214489) pursuant to which the Company issued an aggregate of 3,902,439 shares of common stock at a public offering price of $10.25 per share. The Company received net proceeds of approximately $37,900 from the offering after deducting the underwriting discount and commissions and offering expenses.
Controlled Equity Offering Sales Agreement
On December 7, 2015, the Company entered into a Controlled Equity Offering Sales Agreement (as amended on November 7, 2016 and December 1, 2017, the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which the Company issued and sold through Cantor an aggregate of 9,172,159 shares of the Company’s common stock, for net proceeds of
approximately $89,053. On August 2, 2018, the Company delivered written notice to Cantor terminating the Sales Agreement effective August 12, 2018. Under the Sales Agreement, Cantor sold shares of the Company’s common stock by methods deemed to be an“at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”). The Company paid Cantor a commission of up to 3.0% of the gross proceeds from the sale of the shares of the Company’s common stock pursuant to the Sales Agreement and provided Cantor with customary indemnification and contribution rights.
The Company
The Company has not
Agreement, for net proceeds of approximately $14.6 million.
Long-Term Obligations
Liability Component and recorded as a reduction of the Notes. The portion allocated to the Liability Component is amortized to interest expense using the effective interest method over seven years.
Prior Subject to October 15, 2022,satisfaction of certain conditions and during the Company may not redeem the Notes. On or after October 15, 2022, the Company may redeem for cash all or a portion ofperiods described below, the Notes if the last reported sale price of the Company’s common stock equals or exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending within five trading days prior to the date on which the Company provides notice of redemption. The redemption price willmay be equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. No sinking fund is provided for the Notes.
The Notes are convertible into shares of the Company’s common stockconverted at an initial conversion rate of 63.0731 shares of common stock per $1 principal amount of the Notes (equivalent to an initial conversion price of approximately $15.85 per share of common stock). The conversion rate will be subject to adjustment upon the occurrence of certain events as provided in the Indenture but will not be adjusted for any accrued and unpaid interest. Upon conversion of the Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock or a combination of cash and shares of common stock, at the Company’s election (subject to, and in accordance with, the settlement provisions of the Indenture).
(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 our common stock for at least 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 our common stock and the conversion rate on each such trading day; |
(3) | if we call the Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or |
(4) | upon the occurrence of specified corporate events as described within the indenture governing the Notes. |
The conversion rate is subject to customary anti-dilution adjustments. In addition, if certain corporate events described in the Indenture occur prior to the maturity date, the Company will increase the conversion rate for a holder that elects to convert its Notes in connection with such corporate event in certain circumstances. Furthermore, calling any Note for redemption will result in an increase in the conversion rate applicable to the conversion of that Note, if it is converted in connection with the redemption in certain circumstances.
If the Company undergoes a “fundamental change,” as defined in the Indenture, holders may require the Company to repurchaseredeem for cash all or any portionpart of theirthe Notes at a fundamental change repurchaseour option if the last reported sale price equalof our common stock equals or exceeds 130% of the conversion price then in effect for at least
Liability component: | ||||
Principal | $ | 172,500 | ||
Less: debt discount and issuance costs, net | (64,538 | ) | ||
Net carrying amount | $ | 107,962 | ||
Equity component: | $ | 65,641 | ||
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 | $ | 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.
On August 6,liposarcoma and the Phase 3 SIENDO (
We expect to providetop-line data fromanticipate submitting the SADAL studyNDA by the end of 2018,top-line data from2019 and the BOSTON study in 2019 andtop-line data from the Phase 3 portionMAA during 2020.
We expect to continue to incur significant expenses and operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially if and as we:
continue our research and preclinical and clinical development of our drug candidates;
initiate additional clinical trials for our drug candidates;
seek marketing approvals for any of our drug candidates that successfully complete clinical trials;
establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval;
maintain, expand and protect our intellectual property portfolio;
manufacture our drug candidates;
hire additional clinical, quality control and scientific personnel;
identify additional drug candidates;
acquire orin-license other drugs and technologies; and
add operational, financial and management information systems and personnel, including personnel to support our drug development, any future commercialization efforts and our other operations as a public company.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
10-Q.
Three Months Ended September 30, | ||||||||||||||||
2018 | 2017 | $ Change | % Change | |||||||||||||
(in thousands) | ||||||||||||||||
License and other revenue | $ | 239 | $ | — | $ | 239 | N/A | |||||||||
Operating expenses: | ||||||||||||||||
Research and development | 36,427 | 25,237 | 11,190 | 44 | % | |||||||||||
General and administrative | 12,966 | 5,818 | 7,148 | 123 | % | |||||||||||
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| |||||||||
Loss from operations | (49,154 | ) | (31,055 | ) | (18,099 | ) | 58 | % | ||||||||
Other income, net | 1,085 | 428 | 657 | 154 | % | |||||||||||
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| |||||||||
Loss before income taxes | (48,069 | ) | (30,627 | ) | (17,442 | ) | 57 | % | ||||||||
Income tax provision | (14 | ) | (13 | ) | (1 | ) | 8 | % | ||||||||
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Net loss | $ | (48,083 | ) | $ | (30,640 | ) | $ | (17,443 | ) | 57 | % | |||||
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License2018
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 | )% | ||||||||||||||||||||||||||
2019 only reflects a portion of 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
an increase of $2.0 million in other miscellaneous research and development costs; and
an increase of $1.8$2.7 million in clinical trial costs, primarily related to the selinexor program.
an increase of $1.0 million in occupancy costs; and
an increase of $0.5 million in other administrative costs.
increased approximately $0.7decreased from $1.1 million to $1.1 millionof other income, net for the three months ended September 30, 2018 from approximately $0.4to $1.9 million of other expense, net for the three months ended September 30, 2017.2019. The increasedecrease is primarily due to increased investment returns resulting from a general$3.1 million of interest expense related to the issuance of our 3.00% convertible senior notes due 2025 (Notes) in October 2018.
Nine Months Ended September 30, | ||||||||||||||||
2018 | 2017 | $ Change | % Change | |||||||||||||
(in thousands) | ||||||||||||||||
License and other revenue | $ | 30,130 | $ | 71 | $ | 30,059 | N/A | |||||||||
Operating expenses: | ||||||||||||||||
Research and development | 122,482 | 72,440 | 50,042 | 69 | % | |||||||||||
General and administrative | 30,076 | 18,717 | 11,359 | 61 | % | |||||||||||
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Loss from operations | (122,428 | ) | (91,086 | ) | (31,342 | ) | 34 | % | ||||||||
Other income, net | 2,240 | 1,196 | 1,044 | 87 | % | |||||||||||
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| |||||||||
Loss before income taxes | (120,188 | ) | (89,890 | ) | (30,298 | ) | 34 | % | ||||||||
Income tax provision | (9 | ) | (54 | ) | 45 | (83 | )% | |||||||||
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Net loss | $ | (120,197 | ) | $ | (89,944 | ) | $ | (30,253 | ) | 34 | % | |||||
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2018
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 | % | |||||||||||||||||||||||||||||||||||||
Research and Development Expense. Research and development expense increased2019 from approximately $50.0 million to $122.5 million for the nine months ended September 30, 2018 from approximately $72.4 million for the nine months ended September 30, 2017.2018. The increasedecrease is primarily related to:
an increase
an increase
an increase of $2.0 million related to our obligation to pay a portion of upfront fees received from certain of our license agreements to a third party.
General and Administrative Expense.General and administrative expense increased approximately $11.4 million to $30.1 millionincome, net for the nine months ended September 30, 2018 from approximately $18.7to $4.9 million of other expense, net for the nine months ended September 30, 2017.2019. The increase is primarily related to:
an increase in consulting and professional costs of $3.7 million, primarily related to commercial readiness and compliance;
an increase of $3.1 million in personnel costs, primarily due to increased headcount and related onboarding costs;
an increase of $1.9 million in commercial related activities;
an increase of $1.5 million in occupancy costs; and
an increase of $1.1 million in other administrative costs.
Other Income, net. Other income, net, increased approximately $1.0 million to $2.2 million for the nine months ended September 30, 2018 from approximately $1.2 million for the nine months ended September 30, 2017. The increasedecrease is primarily due to $9.2 million of interest expense related to the issuance of the Notes in October 2018, offset by a $2.1 million increase in interest income due to increased investment returns resulting from a general increase in interest rates and an increase in ourhigher investment balances.
To
As of
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.
On May 23,
We are party to a research agreement with the Multiple Myeloma Research Foundation (MMRF). Under this research agreement, we are obligated to make certain payments to MMRF, including if weout-license selinexor. The terms of this research agreement do not apply to eltanexor,KPT-9274 or verdinexor. During the quarter ended September 30, 2018, we paid approximately $0.3 million of the Antengene upfront cash payment to MMRF, which reflects the amount owed to MMRF under the Antengene License Agreement transaction. In connection with the transaction pursuant to the license agreement with Ono (Ono License Agreement), we paid to MMRF approximately $2.0 million of the upfront cash payment from Ono in the year ended December 31, 2017. We will be obligated to pay MMRF a percentage of any milestone payments from Antengene and Ono and amid-single-digit percentage of any royalty payments from Antengene and Ono. Such payments are recorded within research and development expense in our condensed consolidated statement of operations. As of September 30, 2018, a maximum of $3.8 million in future obligations are remaining under the MMRF agreement.
On January 24, 2018, we entered into the APA with Biogen, pursuant to which Biogen acquired exclusive worldwide rights to develop and commercialize our oral SINE compoundKPT-350 and certain related assets with an initial focus in amyotrophic lateral sclerosis (ALS). Under the terms of the APA, Biogen purchasedKPT-350 and certain related assets and assumed certain related liabilities. We received aone-time upfront payment of $10.0 million from Biogen and are eligible to receive additional payments of up to $207.0 million based on the achievement by Biogen of future specified development and commercial milestones. We are also eligible to receive tiered royalty payments that reach low double digits based on future net sales until the later of the tenth anniversary of the first commercial sale of the applicable product and the expiration of specified patent protection for the applicable product, determined on acountry-by-country basis.
On October 11, 2017 (Ono Effective Date), we entered into the Ono License Agreement, pursuant to which we granted Ono exclusive rights to develop and commercialize, at its own cost, selinexor and eltanexor for the diagnosis, treatment and/or prevention of all human oncology indications in Japan, Republic of Korea, Republic of China (Taiwan) and Hong Kong as well as in the ten Southeast Asian countries currently comprising the Association of Southeast Asian Nations (Ono Territory). Pursuant to the terms of the Ono License Agreement, we received an upfront payment of ¥2.5 billion (US$21.9 million on the date received), and could receive up to ¥10.15 billion (US$90.5 million at the exchange rate as of the Ono Effective Date) in milestone payments, if certain development goals are achieved and up to ¥9.0 billion (US$80.2 million at the exchange rate as of the Ono Effective Date) in milestone payments if certain sales milestones are achieved, as well as a low double-digit royalty basedroyalties on future net sales of selinexorthe licensed and eltanexorsold products in the Ono Territory.
In December 2015, we entered into a sales agreement (as amended on November 7, 2016 and December 1, 2017, the Sales Agreement) with Cantor Fitzgerald & Co., as sales agent (Cantor), relating to an“at-the-market” offering, pursuant to which we issued and sold 9,172,159 sharesterritories under such arrangements.
Nine Months Ended September 30, | ||||||||
2018 | 2017 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (110,945 | ) | $ | (68,179 | ) | ||
Net cash (used in) provided by investing activities | (4,554 | ) | 20,009 | |||||
Net cash provided by financing activities | 148,333 | 52,786 | ||||||
Effect of exchange rate changes | (9 | ) | 181 | |||||
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| |||||
Net increase in cash, cash equivalents and restricted cash | $ | 32,825 | $ | 4,797 | ||||
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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 | ||||||||||||||
from operations during that period.
$7.3 million.
2018.
incur significant commercialization expenses related to drug sales, marketing, manufacturing and distribution of any of our drug candidates for which we obtain marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time for any
such drug. Furthermore, we expect to continue to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
We expect that our cash, cash equivalents and short- and long-term investments as of September 30, 2018, totaling $211.6 million, in addition to the estimated $166.9 million of net proceeds we raised in the private placement of the Notes in October 2018, will be sufficient to fund our current operating and capital expenditure plans for at least twelve months from the date of issuance of the financial statements contained in thisForm 10-Q while we are establishing the commercial infrastructure for a potential launch of selinexor in the United States.
the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our other drug candidates;
our ability to establish and maintain collaborations on favorable terms, if at all;
the success of any collaborations that we may enter into with third parties;
the extent to which we acquire orin-license other drugs and technologies;
In February 2018 and June 2018, we executed separate amendments to the operating lease at our Newton, Massachusetts facility. In aggregate, these amendments increased our leased space by 52,335 square feet and extended the term of the lease from September 30, 2022 to September 30, 2025.
As of September 30, 2018, the total minimum future rent payments under the lease agreements are as follows (in thousands):
Remainder of 2018 | $ | 433 | ||
2019 | 2,983 | |||
2020 | 3,208 | |||
2021 | 3,277 | |||
2022 | 3,447 | |||
2023 | 3,718 | |||
Thereafter | 6,735 | |||
|
| |||
Total future minimum lease payments | $ | 23,801 | ||
|
|
On October 16, 2018, we completed an offering of $150.0 million aggregate principal amount of Notes. In addition, on October 26, 2018, we issued an additional $22.5 million aggregate principal amount of the Notes pursuant to the full exercise of the option to purchase additional Notes granted to the initial purchasers in the offering. The Notes are our senior unsecured obligations and bear interest at a rate of 3.00% per year payable semiannually in arrears on April 15 and October 15 of each year, beginning on April 15, 2019. The Notes will mature on October 15, 2025, unless earlier converted, redeemed or repurchased in accordance with their terms. Upon conversion of the Notes, we will pay or deliver, as the case may be, cash, shares of our common stock or a combination of cash and shares of common stock, at our election (subject to, and in accordance with, the settlement provisions of the indenture).
We cannot commercialize drug candidates in the United States without first obtaining regulatory approval for the drug from On July 3, 2019, the U.S. Food and Drug Administration, or FDA; similarly, we cannot commercializeFDA, granted accelerated approval for XPOVIO in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Our ability to generate product revenues will depend on our successful commercialization of XPOVIO and our obtaining additional marketing approvals for, and successfully commercializing, selinexor for additional indications.
We currently have no drugs approved for sale and we cannot guarantee that we will ever have marketable drugs.
In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same drug candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. We do not know whether any Phase 2, Phase 3 or other clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain regulatory approval to market our drug candidates.
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;
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 and adequate reimbursement by third-party payors, including government payors, for any approved drugs;
maintainingprogression-free survival endpoint as 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.
potential drug candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be drugs that will receive marketing approval and/or achieve market acceptance; or
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.
In addition, many of the factors that cause, or lead to, clinical trial delays may ultimately lead to the denial of regulatory approval of our drug candidates.
information regarding the safety profile of selinexor. The partial clinical holds on the clinical trials of selinexor were lifted by the FDA Division of Hematology Products (effective March 30, 2017), Division of Oncology Products 1 (effective April 5, 2017) and Division of Oncology Products 2 (effective March 31, 2017). However, if in the future we are delayed in addressing, or unable to address, any concerns of the FDA or other regulators, we could be delayed or prevented from enrolling patients in our clinical trials.
candidates or it could delay or prevent regulatory approval, limit commercial viability, or result in significant negative consequences following any marketing approval.
As a result of these
If such an event occurs after any of our drug candidates are approved and/or commercialized, a number of potentially significant negative consequences may result, including:
Even if such drug may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.If
inany of our assumptions or estimates, or these publications, research, surveys or studies prove to be inaccurate, then the future,actual market for XPOVIO, selinexor or any other drug candidates may be smaller than we expect, and as a result our product revenue may be limited and it may be more difficult for us to achieve or maintain profitability.marketingdistribution capabilities or maintain current agreements or enter into additional sales, marketing and distribution agreements with third parties, to sell and market our drug candidates, we may not be successful in commercializing XPOVIO or any of our drug candidates that we may develop if and when they are approved.hasdoes not previously soldhave any prior experience in the sales, marketing or marketeddistribution of pharmaceutical drugs. To achieve commercial success for any approved drug for which sales and marketing is not the responsibility of any strategic collaborator that we have or may have in the future, we must either develop a sales, marketing and marketingdistribution organization or outsource these functions to other third parties. In the future, we may choose to build a sales, marketing and marketingdistribution infrastructure to market ormarketingdistribution of our drug candidates. We are 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.marketingdistribution capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time-consuming and could delay any commercial launch of a drug candidate. Further, we may underestimate the size of the sales force required for a successful product launch and may need to expand our sales force earlier and at a higher cost than we anticipated. If the commercial launch of aany of our drug candidatecandidates for which we recruitestablish a sales force and establish marketing capabilitiescommercial infrastructure is delayed or does not occur for any reason, including if we do not receive marketing approval on the timeframe we expect, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.our drugsXPOVIO or any drug candidates for which we receive marketing approval on our own include:
Significant uncertainty exists as
establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval;
To
Raising Adequate 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, as 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 favorableavailable to us.us on acceptable terms, or at all. If weadequate funds are unablenot available to raise additional funds through equity or debt financings when needed,us on a timely basis, we may be required to delay, limit, reduce or terminate our research and drug development activities for one or commercialization efforts or grant rights to develop and marketmore of our drug candidates or delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize XPOVIO or our drug candidates for which we would otherwise prefer to develop and market ourselves.
obtain marketing approval.
which has subsequently been codified as Accounting Standards Codification
plans and our business could be adversely affected.
In such an event, our financial results and the commercial prospects for our drug candidates could be harmed, our costs could increase and our ability to generate revenues could be delayed, impaired or foreclosed.
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.
Any drugs that we may develop may compete with other drug candidates and drugs for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.
inherentEuropean Medicines Agency (EMA) in drug development. On August 6, 2018, we announced the completion of the rolling submission of an NDA to the FDAJanuary 2019 with a request for acceleratedconditional approval forof selinexor as a new treatment for patients with penta-refractoryheavily pretreated multiple myeloma. On October 5, 2018,myeloma based on the results of the STORM study. During March 2019, the EMA had inspectors conduct a Good Clinical Practices (GCP) inspection at our headquarters, which was also attended by the FDA, accepted for filing our NDA, granted our request for priority review and assigned an action dateas well as inspections of April 6, 2019 undertwo clinical sites that participated in Part 2 of the PDUFA. In its acceptance letter,STORM study. While we did not receive any findings from the FDA, statedin May 2019, the EMA inspectors provided us a written inspection report seeking our responses to various questions and findings. We promptly addressed the questions and findings in the inspection report and submitted proposals to the EMA’s Committee for Medicinal Products for Human Use (CHMP). In September 2019, we received the Day 180 List of Outstanding Issues from CHMP, which identified two issues requiring resolution. First, CHMP requested that it iswe reconfirm the IRC adjudicated response rate to justify a positive benefit-risk assessment and, second, CHMP requested that we address the findings from the GCP inspection and our corrective measures taken to justify that the clinical trial data are of sufficient quality to support a benefit-risk assessment. We are currently planningworking with CHMP to hold an advisory committee meetingaddress both topics and expect to discuss this NDA.receive a decision on the application in early 2020. We have not submitted any other application for, or received any marketing approval of, any of our drug candidates in the United States or in any other jurisdiction. We have limited experience in conducting and managing the clinical trials necessary to obtain marketing approvals, including FDA approval of an NDA.
The process of obtaining marketing approvals, both in the United States and abroad, is a lengthy, expensive and uncertain process. It may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the drug candidates involved.
However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market.
meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit measurement of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective.
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, assuming positive results from our SADAL study and remaining unmet medical need, we intend to use the data from the SADAL study to support aan NDA request that the FDA consider granting accelerated approval for selinexor in relapsed and/or refractory diffuse largeDLBCL.DLBCL, and work with the FDA to determine the appropriate timeline for the submission of the NDA. In November 2018, the FDA granted fast track designation to selinexor for the treatment of patients that have relapsed and/or refractory DLBCL after at least two prior multi-agent therapies and who are ineligible for transplantation, including high dose chemotherapy with stem cell rescue. While the FDA 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, if data from our SADAL study support such an application, 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 may submit to the EMA to support conditional approval of selinexor to treat penta-refractory multiple myeloma, relapsed/refractory diffuse largeB-cell lymphoma, or any other cancer indication.
can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve a different product for the same condition if the FDA concludes that the later product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
Any
Any
they, receive marketing approval for only their approved indications, we, or they, may be subject to warnings or enforcement action for
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:
Reform Officer” and establish a “Regulatory Reform Task Force” to implement the
Since enactment
become effective in 2019. According to the Congressional Budget Office, the repeal of the individual mandate will cause 13 million fewer Americans to be insured in 2027 and premiums in insurance markets may rise. Additionally, onmandate”. On January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain “Cadillac”
Tax Act, the remaining provisions of the ACA are invalid as well. The Trump Administration has recently represented to the Court of Appeals considering this judgment that it does not oppose the lower court’s ruling. 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.
In addition,
More recently, on January 31, 2019, the HHS Office of Inspector General proposed modifications to the federal anti-kickback statute discount safe harbor for the purpose of reducing the cost of drug products to consumers which, among other things, if finalized, will affect discounts paid by manufacturers to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations.
certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.
reputation and our business.
our success in launching and commercializing XPOVIO;
result in substantial damages and may divert management’s time and attention from our business.Webe subject to securities class action litigation.IfWe are a target of this type of litigation. See Part II, Item 1, “Legal Proceedings” in this Quarterly Report on Form it could result in the payment of substantial costsdamages, or possibly fines, and could have a diversionmaterial adverse effect on our reputation, financial condition and results of management’s attention and our resources, which could harm our business.operations.We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and may remain an emerging growth company through 2018. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, reduced disclosure obligations regarding executive compensation and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. irrevocably elected not to avail ourselves of this exemption from new or revised accounting standardsincurred and therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.We will continue to incur increased costs as a result of operating as a public company, and our management will need to continueis required to devote substantial time to compliance initiatives and corporate governance practices.and particularly after we are no longer an “emerging growth company,” we will incur significant legal, accounting and other expenses. In addition, the Sarbanes-Oxley Act of 2002 and rules subsequently implemented by the SEC and Nasdaq have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management
We cannot predict with certaintycostly especially since we are no longer an “emerging growth company,” as defined in the amountJumpstart Our Business Startups Act of additional costs we may incur2012, and are no longer able to continue to operate as a public company, nor can we predict the timingtake advantage of such costs. In addition, the rules and regulationscertain exemptions from various reporting requirements that are applicable to public companies that are often subject“emerging growth companies” and that were applicable to varying interpretations, in many cases dueus prior to their lackJanuary 1, 2019.
Pursuant towith Section 404, we are required to furnish a report by our management on our internal control over financial reporting. However, while we remain an emerging growth company, we are not required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we are engaged in a process to document and evaluate our internal control over financial reporting, which ishas been both costly and challenging. In this regard, weWe will need to continue to dedicate internal resources, potentiallycontinue to engage outside consultants and adoptfollow a detailed work plan to continue to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. There is a risk that in the future neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. In addition, ifIf we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.
Moreover, holders of an aggregate of at least 9.5 million shares of our common stock as of September 30, 2018 have rights, subject to some conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. We have also registered all shares of common stock that we may issue under our equity compensation plans. As a result, these shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates, to the extent applicable.
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) |
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