☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) | |
(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Global Select Market |
☒ |
Accelerated filer |
☐ | ||||
Non-accelerated filer |
☐ |
Smaller reporting company |
||||
Emerging growth company |
Item 1. |
3 |
|||||
3 |
||||||
4 |
||||||
5 |
||||||
6 |
||||||
7 |
||||||
8 |
||||||
Item 2. |
25 |
|||||
Item 3. |
31 |
|||||
Item 4. |
31 |
|||||
Item 1. |
32 |
|||||
Item 1.A. |
32 |
|||||
Item 6. |
71 |
|||||
72 |
Item 1. |
Condensed Consolidated Financial Statements (Unaudited). |
| June 30, 2019 |
December 31, 2018 |
|||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ |
|
$ |
|
||||
| Short-term investments |
|
|
||||||
| Prepaid expenses and other current assets |
|
|
||||||
| Total current assets |
|
|
||||||
| Property and equipment, net |
|
|
||||||
| Operating lease right-of-use assets |
|
— |
||||||
| Long-term investments |
— |
|
||||||
| Restricted cash |
|
|
||||||
| Total assets |
$ |
|
$ |
|
||||
| Liabilities and stockholders’ equity |
||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ |
|
$ |
|
||||
| Accrued expenses |
|
|
||||||
| Deferred revenue |
|
|
||||||
| Operating lease liabilities |
|
— |
||||||
| Deferred rent |
— |
|
||||||
| Other current liabilities |
|
|
||||||
| Total current liabilities |
|
|
||||||
| Convertible senior notes |
|
|
||||||
| Operating lease liabilities, net of current portion |
|
— |
||||||
| Deferred revenue, net of current portion |
|
|
||||||
| Deferred rent, net of current portion |
— |
|
||||||
| Total liabilities |
|
|
||||||
| Stockholders’ equity: |
||||||||
| Preferred stock, $ |
— |
— |
||||||
| Common stock, $ December 31, 2018 |
|
|
||||||
| Additional paid-in capital |
|
|
||||||
| Accumulated other comprehensive income (loss) |
|
( |
) | |||||
| Accumulated deficit |
( |
) |
( |
) | ||||
| Total stockholders’ equity |
|
|
||||||
| |
||||||||
| Total liabilities and stockholders’ equity |
$ |
|
$ |
|
||||
| Three Months Ended, June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2019 |
2018 |
2019 |
2018 |
|||||||||||||
| License and other revenue |
$ |
|
$ |
|
$ |
|
$ |
|
||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
|
|
|
|
||||||||||||
| General and administrative |
|
|
|
|
||||||||||||
| |
||||||||||||||||
| Total operating expenses |
|
|
|
|
||||||||||||
| Loss from operations |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| Other income (expense): |
||||||||||||||||
| Interest income |
|
|
|
|
||||||||||||
| Interest expense |
( |
) |
— |
( |
) |
— |
||||||||||
| Other (expense) income |
( |
) |
|
( |
) |
( |
) | |||||||||
| |
||||||||||||||||
| Total other (expense) income, net |
( |
) |
|
( |
) |
|
||||||||||
| Loss before income taxes |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| Income tax (provision) benefit |
( |
) |
|
( |
) |
|
||||||||||
| Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||
| Net loss per share—basic and diluted |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||
| Weighted-average number of common shares outstanding used in net loss per share—basic and diluted |
|
|
|
|
||||||||||||
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2019 |
2018 |
2019 |
2018 |
|||||||||||||
| Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||
| Comprehensive income (loss) |
||||||||||||||||
| Unrealized gain (loss) on investments |
|
|
|
( |
) | |||||||||||
| Foreign currency translation adjustments |
|
( |
) |
( |
) |
( |
) | |||||||||
| Comprehensive loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||
| Six Months Ended June 30, |
||||||||
| 2019 |
2018 |
|||||||
| Operating activities |
||||||||
| Net loss |
$ |
( |
) |
$ |
( |
) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
| Depreciation and amortization |
|
|
||||||
| Net amortization of premiums and discounts on investments |
( |
) |
|
|||||
| Amortization of debt discount and issuance costs |
|
— |
||||||
| Stock-based compensation expense |
|
|
||||||
| Changes in operating assets and liabilities: |
||||||||
| Prepaid expenses and other current assets |
|
( |
) | |||||
| Operating lease right-of-use assets |
|
— |
||||||
| Accounts payable |
( |
) |
( |
) | ||||
| Accrued expenses and other liabilities |
( |
) |
|
|||||
| Operating lease liabilities |
( |
) |
— |
|||||
| Deferred revenue |
( |
) |
( |
) | ||||
| Deferred rent |
— |
|
||||||
| Net cash used in operating activities |
( |
) |
( |
) | ||||
| Investing activities |
||||||||
| Purchases of property and equipment |
( |
) |
( |
) | ||||
| Proceeds from maturities of investments |
|
|
||||||
| Purchases of investments |
( |
) |
( |
) | ||||
| Net cash provided by (used in) investing activities |
|
( |
) | |||||
| Financing activities |
||||||||
| Proceeds from the issuance of common stock, net of issuance costs |
— |
|
||||||
| Proceeds from the exercise of stock options and shares issued under employee stock purchase plan |
|
|
||||||
| Net cash provided by financing activities |
|
|
||||||
| Effect of exchange rate on cash, cash equivalents and restricted cash |
|
( |
) | |||||
| Net (decrease) increase in cash, cash equivalents and restricted cash |
( |
) |
|
|||||
| Cash, cash equivalents and restricted cash at beginning of period |
|
|
||||||
| Cash, cash equivalents and restricted cash at end of period |
$ |
|
$ |
|
||||
| Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets |
||||||||
| Cash and cash equivalents |
$ |
|
$ |
|
||||
| Short-term restricted cash |
— |
— |
||||||
| Long-term restricted cash |
|
|
||||||
| Total cash, cash equivalents and restricted cash |
$ |
|
$ |
|
||||
| Supplemental disclosures: |
||||||||
| Operating lease right-of-use assets obtained in exchange for operating lease liabilities |
$ |
|
$ |
— |
||||
| Cash paid for amounts included in the measurement of operating lease liabilities |
$ |
|
$ |
— |
||||
| Common Shares |
|||||||||||||||||||||||||
| Shares |
Amount |
Additional Paid-In Capital |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total Stockholders’ Equity (Deficit) |
||||||||||||||||||||
| Balance at March 31, 2019 |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||||||||||
| Vesting of restricted stock |
|
|
|
|
|
|
|||||||||||||||||||
| Exercise of stock options and shares issued under the employee stock purchase plan |
|
— |
|
— |
— |
|
|||||||||||||||||||
| Stock-based compensation expense |
— |
— |
|
— |
— |
|
|||||||||||||||||||
| Unrealized gain on investments |
— |
— |
— |
|
— |
|
|||||||||||||||||||
| Foreign currency translation adjustment |
— |
— |
— |
|
— |
|
|||||||||||||||||||
| Net loss |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Balance at June 30, 2019 |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
| |||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Balance at March 31, 2018 |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||||||||||
| Vesting of restricted stock |
|
|
|
|
|
|
|||||||||||||||||||
| Exercise of stock options and shares issued under the employee stock purchase plan |
|
— |
|
— |
— |
|
|||||||||||||||||||
| Issuance of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
| |
| Stock-based compensation expense |
— |
— |
|
— |
— |
|
|||||||||||||||||||
| Unrealized gain on investments |
— |
— |
— |
|
— |
|
|||||||||||||||||||
| Foreign currency translation adjustment |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||
| Net loss |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||
| Balance at June 30, 2018 |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||||||||||
| Balance at December 31, 2018 |
|
$ |
|
|
$ |
( |
) |
$ |
( |
) |
$ |
|
|||||||||||||
| Vesting of restricted stock |
|
|
|
|
|
|
|||||||||||||||||||
| Exercise of stock options and shares issued under the employee stock purchase plan |
|
— |
|
— |
— |
|
|||||||||||||||||||
| Stock-based compensation expense |
— |
— |
|
— |
— |
|
|||||||||||||||||||
| Unrealized gain on investments |
— |
— |
— |
|
— |
|
|||||||||||||||||||
| Foreign currency translation adjustment |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||
| Net loss |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||
| Balance at June 30, 2019 |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
| |||
| Balance at December 31, 2017 |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||||||||||
| Vesting of restricted stock |
|
|
|
|
|
|
|||||||||||||||||||
| Exercise of stock options and shares issued under the employee stock purchase plan |
|
— |
|
— |
— |
|
|||||||||||||||||||
| Issuance of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
| |
| Stock-based compensation expense |
— |
— |
|
— |
— |
|
|||||||||||||||||||
| Unrealized loss on investments |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||
| Foreign currency translation adjustment |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||
| Net loss |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||
| Balance at June 30, 2018 |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||||||||||
| January 1, 2019 Prior to ASC 842 Adoption |
ASC 842 Adjustment |
January 1, 2019 as Adjusted |
||||||||||
| Consolidated balance sheet data (in thousands): |
||||||||||||
| Operating lease and right-of-use assets (1) |
$ — |
$ |
$ |
|||||||||
| Deferred rent (2) |
$ |
$ ( |
$ — |
|||||||||
| Deferred rent non-current (2) |
$ |
$ ( |
$ — |
|||||||||
| Operating lease liabilities (3) |
$ — |
$ |
$ |
|||||||||
| Non-current operating lease liabilities (3) |
$ — |
$ |
$ |
|||||||||
| (1) | Represents capitalization of operating lease right-of-use assets, offset by reclassification of deferred rent and tenant incentives to operating lease right-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. |
| 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 the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability |
| 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 |
$ |
|
$ |
|
$ |
— |
$ |
— |
||||||||
| Commercial paper |
|
— |
|
— |
||||||||||||
| Investments: |
||||||||||||||||
| Current: |
— |
|||||||||||||||
| Corporate debt securities |
|
— |
|
— |
||||||||||||
| Commercial paper |
|
— |
|
— |
||||||||||||
| U.S. government and agency securities |
|
— |
|
— |
||||||||||||
| Certificate of deposit |
|
— |
|
— |
||||||||||||
$ |
|
$ |
|
$ |
|
$ |
— |
|||||||||
| 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 |
$ |
|
$ |
|
$ |
— |
$ |
— |
||||||||
| Corporate debt securities |
|
— |
|
— |
||||||||||||
| Commercial paper |
|
— |
|
— |
||||||||||||
| Investments: |
||||||||||||||||
| Current: |
||||||||||||||||
| Corporate debt securities |
|
— |
|
— |
||||||||||||
| Commercial paper |
|
— |
|
— |
||||||||||||
| U.S. government and agency securities |
|
— |
|
— |
||||||||||||
| Certificate of deposit |
|
— |
|
— |
||||||||||||
| Non-current: |
||||||||||||||||
| Corporate debt securities (one to two year maturity) |
|
— |
|
— |
||||||||||||
$ |
|
$ |
|
$ |
|
$ |
— |
|||||||||
| Amortized Cost |
Gross Unrealized Gains |
Gross Unrealized Loss |
Fair Value |
|||||||||||||
| Current: |
||||||||||||||||
| Corporate debt securities |
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||||||
| Commercial paper |
|
|
— |
|
||||||||||||
| U.S. government and agency securities |
|
|
( |
) |
|
|||||||||||
| Certificate of deposit |
|
— |
— |
|
||||||||||||
$ |
|
$ |
|
$ |
( |
) |
$ |
|
||||||||
| Amortized Cost |
Gross Unrealized Gains |
Gross Unrealized Loss |
Fair Value |
|||||||||||||
| Current: |
||||||||||||||||
| Corporate debt securities |
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||||||
| Commercial paper |
|
— |
( |
) |
|
|||||||||||
| U.S. government and agency securities |
|
|
( |
) |
|
|||||||||||
| Certificate of deposit |
|
— |
( |
) |
|
|||||||||||
| Non-current: |
||||||||||||||||
| Corporate debt securities (one to two year maturity) |
|
— |
( |
) |
|
|||||||||||
$ |
|
$ |
|
$ |
( |
) |
$ |
|
||||||||
| Three and Six Months Ended June 30, |
||||||||
| 2019 |
2018 |
|||||||
| Outstanding stock options |
|
|
||||||
| Unvested restricted stock units |
|
|
||||||
| Shares |
Weighted- Average Exercise Price Per Share |
Weighted- Average Remaining Contractual Term (years) |
Aggregate Intrinsic Value (in thousands) |
|||||||||||||
| Outstanding at December 31, 2018 |
|
$ |
|
|
$ |
|
||||||||||
| Granted |
|
|
||||||||||||||
| Exercised |
( |
) |
|
|||||||||||||
| Canceled |
( |
) |
|
|||||||||||||
| Outstanding at June 30, 2019 |
|
|
|
$ |
|
|||||||||||
| Exercisable at June 30, 2019 |
|
$ |
|
|
$ |
|
||||||||||
| Number of Shares Underlying RSUs |
Weighted- Average Grant Date Fair Value |
|||||||
| Unvested at December 31, 2018 |
|
$ |
|
|||||
| Granted |
|
|
||||||
| Forfeited |
( |
) |
|
|||||
| Vested |
( |
) |
|
|||||
| Unvested at June 30, 2019 |
|
$ |
|
|||||
| Years ended December 31, |
Future Minimum Payments |
| |||
| 2019 |
$ |
|
| ||
| 2020 |
|
| |||
| 2021 |
|
| |||
| 2022 |
|
| |||
| 2023 and thereafter |
|
| |||
| | |||||
| Total minimum lease payments |
$ |
|
| ||
| Less: present value adjustment |
( |
) |
| ||
| | |||||
| Present value of minimum lease payments |
$ |
|
| ||
| | |||||
| (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 the Company’s common stock for at least | |
| |
|
|
| (2) | five | |
| |
|
|
| (3) | if the Company calls 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. |
| Liability component: |
||||
| Principal |
$ |
|
||
| Less: debt discount and issuance costs, net |
( |
) | ||
| Net carrying amount |
$ |
|
||
| Equity component: |
$ |
|
||
| Six Months Ended June 30, 2019 |
||||
| Contractual interest expense |
$ |
|
||
| Amortization of debt discount |
|
|||
| Amortization of debt issuance costs |
|
|||
| Total interest expense |
$ |
|
||
| Years ended December 31, |
Future Minimum Payments |
| |||
| 2019 |
$ |
|
| ||
| 2020 |
|
| |||
| 2021 |
|
| |||
| 2022 |
|
| |||
| 2023 and thereafter |
|
| |||
| Total minimum payments |
$ |
|
| ||
| Less: interest |
( |
) |
| ||
| Less: unamortized discount |
( |
) |
| ||
| Less: current portion |
|
| |||
| Long term debt |
$ |
|
| ||
| Three Months Ended June 30, |
|||||||||||||||||
| 2019 |
2018 |
$ Change |
% Change |
||||||||||||||
| (in thousands) |
|||||||||||||||||
| License and other revenue |
$ | 9,493 |
$ | 19,891 |
$ | (10,398 |
) | (52.3)% |
|||||||||
| Operating expenses: |
|||||||||||||||||
| Research and development |
26,517 |
44,734 |
(18,217 |
) | (40.7)% |
||||||||||||
| General and administrative |
24,662 |
9,489 |
15,173 |
159.9% |
|||||||||||||
| Loss from operations |
(41,686 |
) | (34,332 |
) | (7,354 |
) | 21.4% |
||||||||||
| Other (expense) income, net |
(1,721 |
) | 660 |
(2,381 |
) | (360.8)% |
|||||||||||
| Loss before income taxes |
(43,407 |
) | (33,672 |
) | (9,735 |
) | 28.9% |
||||||||||
| Income tax (provision) benefit |
(8 |
) | 17 |
(25 |
) | (147.1)% |
|||||||||||
| Net loss |
$ | (43,415 |
) | $ | (33,655 |
) | $ | (9,760 |
) | 29.0% |
|||||||
| • | a decrease of $9.4 million in personnel costs and consulting and professional expense; |
| • | a decrease of $8.0 million in clinical trial costs, primarily related to the selinexor program; |
| • | a decrease of $0.8 million in miscellaneous costs; and |
| • | a decrease of $0.3 million in travel costs; offset by |
| • | an increase of $0.3 million in facility costs and IT infrastructure costs. |
| • | an increase of $10.3 million in personnel costs, primarily due to increased headcount and related onboarding costs associated with building our commercial team in preparation for the U.S. commercial launch of XPOVIO; |
| • | an increase of $2.4 million in commercial related activities; |
| • | an increase of $1.8 million in facility costs and IT infrastructure costs; and |
| • | an increase of $1.4 million in costs related to corporate training, travel and corporate events; offset by |
| • | a decrease of $0.5 million in consulting and professional costs; and |
| • | a decrease of $0.2 million in miscellaneous costs. |
| Six Months Ended June 30, |
|||||||||||||||||
| 2019 |
2018 |
$ Change |
% Change |
||||||||||||||
| (in thousands) |
|||||||||||||||||
| License and other revenue |
$ | 9,648 |
$ | 29,891 |
$ | (20,243 |
) | (67.7)% |
|||||||||
| Operating expenses: |
|||||||||||||||||
| Research and development |
64,491 |
86,055 |
(21,564 |
) | (25.1)% |
||||||||||||
| General and administrative |
51,765 |
17,110 |
34,655 |
202.5% |
|||||||||||||
| Loss from operations |
(106,608 |
) | (73,274 |
) | (33,334 |
) | 45.5% |
||||||||||
| Other (expense) income, net |
(2,950 |
) | 1,155 |
(4,105 |
) | (355.4)% |
|||||||||||
| Loss before income taxes |
(109,558 |
) | (72,119 |
) | (37,439 |
) | 51.9% |
||||||||||
| Income tax (provision) benefit |
(18 |
) | 5 |
(23 |
) | (460.0)% |
|||||||||||
| Net loss |
$ | (109,576 |
) | $ | (72,114 |
) | $ | (37,462 |
) | 51.9% |
|||||||
| • | a decrease of $11.0 million in clinical trial costs, primarily related to the selinexor program; |
| • | a decrease of $10.1 million in personnel costs and consulting and professional expense; and |
| • | a decrease of $1.2 million in miscellaneous costs; offset by |
| • | an increase of $0.7 million in facility costs and IT infrastructure costs. |
| • | an increase of $21.3 million in personnel costs, primarily due to increased headcount and related onboarding costs associated with building our commercial team in preparation for the U.S. commercial launch of XPOVIO; |
| • | an increase of $6.4 million in commercial related activities; |
| • | an increase of $3.9 million in costs related to corporate training, travel and corporate events; |
| • | an increase of $3.3 million in facility costs and IT infrastructure costs; and |
| • | an increase of $0.7 million in consulting and professional costs; offset by |
| • | a decrease of $0.9 million in miscellaneous costs. |
| Six Months Ended June 30, |
||||||||
| 2019 |
2018 |
|||||||
| (in thousands) |
||||||||
| Net cash used in operating activities |
$ | (114,827 |
) | $ | (72,280 |
) | ||
| Net cash provided by (used in) investing activities |
71,794 |
(25,120 |
) | |||||
| Net cash provided by financing activities |
547 |
147,561 |
||||||
| Effect of exchange rate changes |
9 |
(44 |
) | |||||
| Net decrease in cash, cash equivalents and restricted cash |
$ | 42,477 |
$ | 50,117 |
||||
| • | revenue generated from commercial sales of XPOVIO; |
| • | costs related to the sales and marketing of XPOVIO; |
| • | the costs, timing and outcome of regulatory review of our drug candidates; |
| • | the costs of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our drug candidates for which we receive 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; |
| • | the amount of revenue received from commercial sales of our drug candidates for which we receive marketing approval; |
| • | the progress and results of our current and planned clinical trials of selinexor; |
| • | 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 or in-license other drugs and technologies; |
| • | the costs associated with legal activities, including litigation, arising in the course of business activities and our ability to prevail in any such legal disputes; and |
| • | the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims. |
| • | successful commercialization of XPOVIO in the United States, including establishing sales, marketing and distribution capabilities for XPOVIO; |
| • | the consistency of any new data we collect and analyses we conduct with prior results, whether they support a favorable safety, efficacy and effectiveness profile of XPOVIO and any potential impact on our FDA accelerated approval and/or FDA package insert for XPOVIO; |
| • | our ability to comply with FDA post-marketing requirements and commitments, including through successfully conducting additional studies that confirm clinical efficacy, effectiveness and safety of XPOVIO and acceptance of the same by the FDA and medical community since continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials; |
| • | acceptance of XPOVIO and, if and when approved, our drug candidates by patients, the medical community and third-party payors; |
| • | obtaining and maintaining coverage, adequate pricing and adequate reimbursement by third-party payors, including government payors, for XPOVIO and our drug candidates; |
| • | 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 drug candidates for which we may obtain marketing approval, whether alone or in collaboration with others; |
| • | launching commercial sales of any drug candidates for which we obtain marketing approval, whether alone or in collaboration with others; |
| • | effectively competing with other therapies; |
| • | maintaining an acceptable safety profile of the drugs following approval; |
| • | enforcing and defending intellectual property rights and claims; and |
| • | maintaining and growing an organization of scientists and business people, including collaborators, who can develop and commercialize our drug candidates. |
| • | the research methodology used may not be successful in identifying potential drug candidates; |
| • | 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 |
| • | potential drug candidates may not be effective in treating their targeted diseases. |
| • | regulatory authorities or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
| • | feedback from regulatory authorities that requires us to modify the design of our clinical trials; |
| • | we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or contract research organizations; |
| • | clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulatory authorities may require us, to conduct additional clinical trials, suspend ongoing clinical trials or abandon drug development programs; |
| • | the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; |
| • | our third-party contractors, including those manufacturing our drug candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
| • | we or our investigators might have to suspend or terminate clinical trials of our drug candidates for various reasons, including non-compliance with regulatory requirements, a finding that our drug candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks; |
| • | regulators may recommend or require us to perform additional or unanticipated clinical trials to obtain approval; |
| • | regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; |
| • | the cost of clinical trials of our drug candidates may be greater than we anticipate; |
| • | the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; |
| • | regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; and |
| • | any partners and collaborators that help conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us. |
| • | be delayed in obtaining marketing approval for our drug candidates; |
| • | not obtain marketing approval at all; |
| • | obtain marketing approval in some countries and not in others; |
| • | obtain approval for indications or patient populations that are not as broad as intended or desired; |
| • | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings; |
| • | be subject to additional post-marketing testing requirements; or |
| • | have the drug removed from the market after obtaining marketing approval. |
| • | severity of the disease under investigation; |
| • | availability and efficacy of approved drugs for the disease under investigation; |
| • | patient eligibility criteria for the study in question; |
| • | competing drugs in clinical development; |
| • | perceived risks and benefits of the drug candidate under study; |
| • | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; |
| • | efforts to facilitate timely enrollment in clinical trials; |
| • | patient referral practices of physicians; |
| • | the ability to monitor patients adequately during and after treatment; and |
| • | proximity and availability of clinical trial sites for prospective patients. |
| • | regulatory authorities may withdraw the approval of such drug; |
| • | regulatory authorities may require additional warnings on the label or impose distribution or use restrictions; |
| • | regulatory authorities may require one or more postmarketing studies; |
| • | regulatory authorities may withdraw the approval of such drug; |
| • | we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; |
| • | we could be sued and held liable for harm caused to patients; and |
| • | our reputation may suffer. |
| • | efficacy and potential advantages compared to alternative treatments; |
| • | the ability to offer our drugs for sale at competitive prices; |
| • | convenience and ease of administration compared to alternative treatments; |
| • | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
| • | the strength of marketing and distribution support; |
| • | the timing of market introduction of competitive products; |
| • | sufficient third-party coverage or reimbursement; |
| • | effectiveness of our sales and marketing efforts; |
| • | adverse publicity about our drugs or favorable publicity about competitive products; |
| • | the prevalence and severity of any side effects; |
| • | any restrictions on the use of our drugs together with other medications; and |
| • | inability of certain types of patients to take our drugs. |
| • | our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; |
| • | the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future drugs; |
| • | the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive drug lines; |
| • | unforeseen costs and expenses associated with creating an independent sales, marketing and distribution organization; and |
| • | inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies. |
| • | decreased demand for XPOVIO and any other drugs that we may develop; |
| • | injury to our reputation and significant negative media attention; |
| • | withdrawal of clinical trial participants; |
| • | initiation of investigations by regulators; |
| • | product recalls, withdrawals or labeling, marketing or promotional restrictions; |
| • | significant costs to defend the related litigation; |
| • | substantial monetary awards to trial participants or patients; |
| • | loss of revenue; |
| • | reduced resources of our management to pursue our business strategy; and |
| • | the inability to successfully commercialize XPOVIO and any other drugs that we may develop. |
| • | potentially reduced protection for intellectual property rights; |
| • | the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market (with low or lower prices) rather than buying them locally; |
| • | unexpected changes in tariffs, trade barriers and regulatory requirements; |
| • | economic weakness, including inflation, volatility in currency exchange rates or political instability in particular foreign economies and markets; |
| • | workforce uncertainty in countries where labor unrest is more common than in the United States; |
| • | production shortages resulting from any events affecting a product candidate and/or finished drug product supply or manufacturing capabilities abroad; |
| • | business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes, typhoons, floods and fires; and |
| • | failure to comply with Office of Foreign Asset Control rules and regulations and the Foreign Corrupt Practices Act, or FCPA. |
| • | continue to commercialize XPOVIO in the United States and seek regulatory approval for XPOVIO outside of the United States; |
| • | continue to grow our sales, marketing and distribution infrastructure during the commercialization of XPOVIO and any drug candidates for which we may obtain marketing approval, prior to or upon receiving marketing approval; |
| • | 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; |
| • | maintain, expand and protect our intellectual property portfolio; |
| • | manufacture our drug candidates; |
| • | hire additional clinical, quality control, scientific, commercial and management personnel; |
| • | identify additional drug candidates; |
| • | acquire or in-license other drugs and technologies; |
| • | add operational, financial and management information systems and personnel, including personnel to support our drug development, any commercialization efforts and our other operations as a public company; and |
| • | increase our product liability insurance coverage as we initiate and expand our commercialization efforts. |
| • | successful launching of XPOVIO, including by further developing our sales force, marketing and distribution capabilities; |
| • | achieving an adequate level of market acceptance and obtaining and maintaining coverage and adequate reimbursement from third-party payors for XPOVIO and any other drugs we commercialize; |
| • | completing preclinical studies and clinical trials of our drug candidates; |
| • | obtaining marketing approval for these drug candidates; |
| • | manufacturing at commercial scale, marketing, selling and distributing XPOVIO or any drug candidates for which we may obtain marketing approval; |
| • | maintaining regulatory and marketing approvals for XPOVIO and for any drug candidates for which we obtain marketing approval; |
| • | establishing and managing any collaborations for the development, marketing and/or commercialization of our drug candidates; |
| • | hiring and building a full commercial organization required for the marketing, selling and distribution for those drugs for which we obtain marketing approval; and |
| • | obtaining, maintaining and protecting our intellectual property rights. |
| • | our ability to successfully commercialize and sell XPOVIO in the United States; |
| • | the cost of, and our ability to expand and maintain, the commercial infrastructure required to support the commercialization of XPOVIO and any other drug for which we receive marketing approval, including product sales, medical affairs, marketing and distribution; |
| • | the progress and results of our current and planned clinical trials of selinexor; |
| • | the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our other drug candidates; |
| • | the costs, timing and outcome of regulatory review of our drug candidates, including whether any additional clinical trials or other activities are required for approval or label expansion; |
| • | our ability to establish and maintain collaborations on favorable terms; |
| • | the success of any collaborations that we have entered into and may enter into with third parties; |
| • | the extent to which we acquire or in-license other drugs and technologies; |
| • | the costs of commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our drug candidates for which we receive marketing approval, and pre-commercialization costs for our drug candidates incurred prior to receiving any such marketing approval, including the costs and timing of establishing product sales, marketing, manufacturing and distribution capabilities that are not the responsibility of any collaborator that we may have at such time; |
| • | the amount of revenue, if any, received from commercial sales of our drug candidates, assuming receipt of marketing approval; |
| • | the terms and timing of any future collaborations, partnerships, licensing, marketing, distribution or other arrangements that we may establish; and |
| • | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims. |
| • | increasing our vulnerability to adverse economic and industry conditions; |
| • | limiting our ability to obtain additional financing; |
| • | requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, which will reduce the amount of cash available for other purposes; |
| • | limiting our flexibility to plan for, or react to, changes in our business; |
| • | diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon conversion of the Notes; and |
| • | placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital. |
| • | collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; |
| • | collaborators may not perform their obligations as expected or in compliance with applicable regulatory requirements; |
| • | collaborators may not pursue development, marketing and/or commercialization of our drug candidates or may elect not to continue or renew development, marketing or commercialization programs based on clinical trial results, changes in the |
| collaborator’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; |
| • | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing; |
| • | collaborators could independently develop, or develop with third parties, drugs that compete directly or indirectly with our drugs or drug candidates if the collaborators believe that competitive drugs are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; |
| • | a collaborator with marketing and distribution rights to one or more drugs may not commit sufficient resources to the marketing and distribution of such drug or drugs; |
| • | disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of drug candidates, might lead to additional responsibilities for us with respect to drug candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; |
| • | collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; |
| • | collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; |
| • | disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our drugs or drug candidates or that result in costly litigation or arbitration that diverts management’s attention and resources of our company; |
| • | we may lose certain valuable rights under circumstances identified in any collaboration arrangement that we enter into, such as if we undergo a change of control; |
| • | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development, marketing and/or commercialization of the applicable drug candidates; |
| • | collaborators may learn about our discoveries and use this knowledge to compete with us in the future; and |
| • | the number and type of our collaborations could adversely affect our attractiveness to collaborators or acquirers. |
| • | reliance on the third party for regulatory compliance and quality assurance; |
| • | the possible breach of the manufacturing agreement by the third party; |
| • | the possible failure of the third party to manufacture our drugs or drug candidates according to our schedule, or at all, including if the third-party manufacturer gives greater priority to the supply of other drugs over our drugs and drug candidates, or otherwise does not satisfactorily perform according to the terms of the manufacturing agreement; |
| • | equipment malfunctions, power outages or other general disruptions experienced by our third-party manufacturers to their respective operations and other general problems with a multi-step manufacturing process; |
| • | the possible misappropriation or disclosure by the third party or others of our proprietary information, including our trade secrets and know-how; and |
| • | the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us. |
| • | litigation involving patients taking our drug; |
| • | restrictions on such drugs, manufacturers or manufacturing processes; |
| • | restrictions on the labeling or marketing of a drug; |
| • | restrictions on drug distribution or use; |
| • | requirements to conduct post-marketing studies or clinical trials; |
| • | warning letters or untitled letters; |
| • | withdrawal of the drugs from the market; |
| • | refusal to approve pending applications or supplements to approved applications that we submit; |
| • | recall of drugs; |
| • | fines, restitution or disgorgement of profits or revenues; |
| • | suspension or withdrawal of marketing approvals; |
| • | damage to relationships with any potential collaborators; |
| • | unfavorable press coverage and damage to our reputation; |
| • | refusal to permit the import or export of drugs; |
| • | drug seizure; or |
| • | injunctions or the imposition of civil or criminal penalties. |
| • | an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents; |
| • | an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; |
| • | expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance; |
| • | a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and 70% starting January 1, 2019) point-of-sale discounts off negotiated prices to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D; |
| • | extension of manufacturers’ Medicaid rebate liability; |
| • | expansion of eligibility criteria for Medicaid programs; |
| • | expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; |
| • | new requirements to report certain financial arrangements with physicians and teaching hospitals; |
| • | a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and |
| • | a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. |
| • | Anti-Kickback Statute |
| • | False Claims Act per-claim penalties, currently set at $5,500 to $11,000 per false claim; |
| • | HIPAA |
| • | Transparency Requirements |
| • | Analogous State and Foreign Laws |
| • | establish a classified board of directors such that not all members of the board are elected at one time; |
| • | allow the authorized number of our directors to be changed only by resolution of our board of directors; |
| • | limit the manner in which stockholders can remove directors from the board; |
| • | establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors; |
| • | require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; |
| • | limit who may call stockholder meetings; |
| • | authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and |
| • | require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws. |
| • | our success in launching and commercializing XPOVIO; |
| • | the success of competitive drugs or technologies; |
| • | results of clinical trials of our drug candidates or those of our competitors; |
| • | our success in commercializing our drug candidates, if and when approved; |
| • | regulatory or legal developments in the United States and other countries; |
| • | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
| • | the recruitment or departure of key personnel; |
| • | the level of expenses related to the commercial launch of XPOVIO and clinical development programs for any of our drug candidates; |
| • | the results of our efforts to discover, develop, acquire or in-license additional drug candidates or drugs; |
| • | actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; |
| • | variations in our financial results or those of companies that are perceived to be similar to us; |
| • | changes in the structure of healthcare payment systems; |
| • | market conditions in the pharmaceutical and biotechnology sectors; |
| • | general economic, industry and market conditions; and |
| • | the other factors described in this “Risk Factors” section. |
| Exhibit Number |
Form |
Incorporated by Reference |
Provided Herewith |
|||||||||||||||||||||
| Description of Exhibit |
File Number |
Date of Filing |
Exhibit Number |
|||||||||||||||||||||
| 3.1 |
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: August 7, 2019 |
By: |
/s/ MICHAEL KAUFFMAN | ||
| Michael Kauffman, M.D., Ph.D. | ||||
| Chief Executive Officer | ||||
| (Principal executive officer) | ||||
| Date: August 7, 2019 |
By: |
/s/ MICHAEL MASON | ||
| Michael Mason | ||||
| Senior Vice President, Chief Financial Officer and Treasurer | ||||
| (Principal financial and accounting officer) | ||||
Exhibit 3.1
RESTATED CERTIFICATE OF INCORPORATION
OF
KARYOPHARM THERAPEUTICS INC.
(originally incorporated on December 22, 2008)
FIRST: The name of the Corporation is Karyopharm Therapeutics Inc. (the “Corporation”).
SECOND: The address of the Corporation’s registered office in the State of Delaware is Corporation Trust Center, 1209 Orange Street, in the City of Wilmington, County of New Castle, 19801. The name of its registered agent at that address is The Corporation Trust Company.
THIRD: The nature of the business or purposes to be conducted or promoted by the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware.
FOURTH: The total number of shares of all classes of stock which the Corporation shall have authority to issue is 105,000,000 shares, consisting of (i) 100,000,000 shares of Common Stock, $0.0001 par value per share (“Common Stock”), and (ii) 5,000,000 shares of Preferred Stock, $0.0001 par value per share (“Preferred Stock”).
The following is a statement of the designations and the powers, privileges and rights, and the qualifications, limitations or restrictions thereof in respect of each class of capital stock of the Corporation.
A COMMON STOCK.
1. General. The voting, dividend and liquidation rights of the holders of the Common Stock are subject to and qualified by the rights of the holders of the Preferred Stock of any series as may be designated by the Board of Directors of the Corporation (the “Board of Directors”) upon any issuance of the Preferred Stock of any series.
2. Voting. The holders of the Common Stock shall have voting rights at all meetings of stockholders, each such holder being entitled to one vote for each share thereof held by such holder; provided, however, that, except as otherwise required by law, holders of Common Stock shall not be entitled to vote on any amendment to this Certificate of Incorporation (which, as used herein, shall mean the certificate of incorporation of the Corporation, as amended from time to time, including the terms of any certificate of designations of any series of Preferred Stock) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon pursuant to this Certificate of Incorporation. There shall be no cumulative voting.
The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law of the State of Delaware.
3. Dividends. Dividends may be declared and paid on the Common Stock from funds lawfully available therefor as and when determined by the Board of Directors and subject to any preferential dividend or other rights of any then outstanding Preferred Stock.
4. Liquidation. Upon the dissolution or liquidation of the Corporation, whether voluntary or involuntary, holders of Common Stock will be entitled to receive all assets of the Corporation available for distribution to its stockholders, subject to any preferential or other rights of any then outstanding Preferred Stock.
B PREFERRED STOCK.
Preferred Stock may be issued from time to time in one or more series, each of such series to have such terms as stated or expressed herein and in the resolution or resolutions providing for the issue of such series adopted by the Board of Directors as hereinafter provided. Any shares of Preferred Stock which may be redeemed, purchased or acquired by the Corporation may be reissued except as otherwise provided by law.
Authority is hereby expressly granted to the Board of Directors from time to time to issue the Preferred Stock in one or more series, and in connection with the creation of any such series, by adopting a resolution or resolutions providing for the issuance of the shares thereof and by filing a certificate of designations relating thereto in accordance with the General Corporation Law of the State of Delaware, to determine and fix the number of shares of such series and such voting powers, full or limited, or no voting powers, and such designations, preferences and relative participating, optional or other special rights, and qualifications, limitations or restrictions thereof, including without limitation thereof, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be stated and expressed in such resolutions, all to the full extent now or hereafter permitted by the General Corporation Law of the State of Delaware. Without limiting the generality of the foregoing, the resolutions providing for issuance of any series of Preferred Stock may provide that such series shall be superior or rank equally or be junior to any other series of Preferred Stock to the extent permitted by law.
The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares then outstanding) by the affirmative vote of the holders of a majority of the voting power of the capital stock of the Corporation entitled to vote thereon, voting as a single class, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law of the State of Delaware.
FIFTH: Except as otherwise provided herein, the Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by statute and this Certificate of Incorporation, and all rights conferred upon stockholders herein are granted subject to this reservation.
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SIXTH: In furtherance and not in limitation of the powers conferred upon it by the General Corporation Law of the State of Delaware, and subject to the terms of any series of Preferred Stock, the Board of Directors shall have the power to adopt, amend, alter or repeal the By-laws of the Corporation by the affirmative vote of a majority of the directors present at any regular or special meeting of the Board of Directors at which a quorum is present. The stockholders may not adopt, amend, alter or repeal the By-laws of the Corporation, or adopt any provision inconsistent therewith, unless such action is approved, in addition to any other vote required by this Certificate of Incorporation, by the affirmative vote of the holders of at least seventy-five percent (75%) of the votes that all the stockholders would be entitled to cast in any annual election of directors or class of directors. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article SIXTH.
SEVENTH: Except to the extent that the General Corporation Law of the State of Delaware prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty, no director of the Corporation shall be personally liable to the Corporation or its stockholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability. No amendment to or repeal of this provision shall apply to or have any effect on the liability or alleged liability of any director of the Corporation for or with respect to any acts or omissions of such director occurring prior to such amendment or repeal. If the General Corporation Law of the State of Delaware is amended to permit further elimination or limitation of the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law of the State of Delaware as so amended.
EIGHTH: The Corporation shall provide indemnification as follows:
1. Actions, Suits and Proceedings Other than by or in the Right of the Corporation. The Corporation shall indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Corporation) by reason of the fact that he or she is or was, or has agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) (all such persons being referred to hereafter as an “Indemnitee”), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974), and amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if Indemnitee acted in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The termination of any action, suit or proceeding by judgment, order,
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settlement, conviction or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful.
2. Actions or Suits by or in the Right of the Corporation. The Corporation shall indemnify any Indemnitee who was or is a party to or threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that Indemnitee is or was, or has agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if Indemnitee acted in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, except that no indemnification shall be made under this Section 2 in respect of any claim, issue or matter as to which Indemnitee shall have been adjudged to be liable to the Corporation, unless, and only to the extent, that the Court of Chancery of Delaware or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of such liability but in view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to indemnity for such expenses (including attorneys’ fees) which the Court of Chancery of Delaware or such other court shall deem proper.
3. Indemnification for Expenses of Successful Party. Notwithstanding any other provisions of this Article EIGHTH, to the extent that an Indemnitee has been successful, on the merits or otherwise, in defense of any action, suit or proceeding referred to in Sections 1 and 2 of this Article EIGHTH, or in defense of any claim, issue or matter therein, or on appeal from any such action, suit or proceeding, Indemnitee shall be indemnified against all expenses (including attorneys’ fees) actually and reasonably incurred by or on behalf of Indemnitee in connection therewith. Without limiting the foregoing, if any action, suit or proceeding is disposed of, on the merits or otherwise (including a disposition without prejudice), without (i) the disposition being adverse to Indemnitee, (ii) an adjudication that Indemnitee was liable to the Corporation, (iii) a plea of guilty or nolo contendere by Indemnitee, (iv) an adjudication that Indemnitee did not act in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the Corporation, and (v) with respect to any criminal proceeding, an adjudication that Indemnitee had reasonable cause to believe his or her conduct was unlawful, Indemnitee shall be considered for the purposes hereof to have been wholly successful with respect thereto.
4. Notification and Defense of Claim. As a condition precedent to an Indemnitee’s right to be indemnified, such Indemnitee must notify the Corporation in writing as soon as practicable of any action, suit, proceeding or investigation involving such Indemnitee for which indemnity will or could be sought. With respect to any action, suit, proceeding or investigation of which the Corporation is so notified, the Corporation will be entitled to participate therein at its own expense and/or to assume the defense thereof at its own expense, with legal counsel
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reasonably acceptable to Indemnitee. After notice from the Corporation to Indemnitee of its election so to assume such defense, the Corporation shall not be liable to Indemnitee for any legal or other expenses subsequently incurred by Indemnitee in connection with such action, suit, proceeding or investigation, other than as provided below in this Section 4. Indemnitee shall have the right to employ his or her own counsel in connection with such action, suit, proceeding or investigation, but the fees and expenses of such counsel incurred after notice from the Corporation of its assumption of the defense thereof shall be at the expense of Indemnitee unless (i) the employment of counsel by Indemnitee has been authorized by the Corporation, (ii) counsel to Indemnitee shall have reasonably concluded that there may be a conflict of interest or position on any significant issue between the Corporation and Indemnitee in the conduct of the defense of such action, suit, proceeding or investigation or (iii) the Corporation shall not in fact have employed counsel to assume the defense of such action, suit, proceeding or investigation, in each of which cases the fees and expenses of counsel for Indemnitee shall be at the expense of the Corporation, except as otherwise expressly provided by this Article EIGHTH. The Corporation shall not be entitled, without the consent of Indemnitee, to assume the defense of any claim brought by or in the right of the Corporation or as to which counsel for Indemnitee shall have reasonably made the conclusion provided for in clause (ii) above. The Corporation shall not be required to indemnify Indemnitee under this Article EIGHTH for any amounts paid in settlement of any action, suit, proceeding or investigation effected without its written consent. The Corporation shall not settle any action, suit, proceeding or investigation in any manner which would impose any penalty or limitation on Indemnitee without Indemnitee’s written consent. Neither the Corporation nor Indemnitee will unreasonably withhold or delay its consent to any proposed settlement.
5. Advance of Expenses. Subject to the provisions of Section 6 of this Article EIGHTH, in the event of any threatened or pending action, suit, proceeding or investigation of which the Corporation receives notice under this Article EIGHTH, any expenses (including attorneys’ fees) incurred by or on behalf of an Indemnitee in defending an action, suit, proceeding or investigation or any appeal therefrom shall be paid by the Corporation in advance of the final disposition of such matter; provided, however, that the payment of such expenses incurred by or on behalf of Indemnitee in advance of the final disposition of such matter shall be made only upon receipt of an undertaking by or on behalf of Indemnitee to repay all amounts so advanced in the event that it shall ultimately be determined by final judicial decision from which there is no further right to appeal that Indemnitee is not entitled to be indemnified by the Corporation as authorized in this Article EIGHTH; and provided further that no such advancement of expenses shall be made under this Article EIGHTH if it is determined (in the manner described in Section 6 of this Article EIGHTH) that (i) Indemnitee did not act in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the Corporation, or (ii) with respect to any criminal action or proceeding, Indemnitee had reasonable cause to believe his or her conduct was unlawful. Such undertaking shall be accepted without reference to the financial ability of Indemnitee to make such repayment.
6. Procedure for Indemnification and Advancement of Expenses. In order to obtain indemnification or advancement of expenses pursuant to Section 1, 2, 3 or 5 of this Article EIGHTH, an Indemnitee shall submit to the Corporation a written request. Any such advancement of expenses shall be made promptly, and in any event within 60 days after receipt by the Corporation of the written request of Indemnitee, unless (i) the Corporation has assumed
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the defense pursuant to Section 4 of this Article EIGHTH (and none of the circumstances described in Section 4 of this Article EIGHTH that would nonetheless entitle the Indemnitee to indemnification for the fees and expenses of separate counsel have occurred) or (ii) the Corporation determines within such 60-day period that Indemnitee did not meet the applicable standard of conduct set forth in Section 1, 2 or 5 of this Article EIGHTH, as the case may be. Any such indemnification, unless ordered by a court, shall be made with respect to requests under Section 1 or 2 of this Article EIGHTH only as authorized in the specific case upon a determination by the Corporation that the indemnification of Indemnitee is proper because Indemnitee has met the applicable standard of conduct set forth in Section 1 or 2 of this Article EIGHTH, as the case may be. Such determination shall be made in each instance (a) by a majority vote of the directors of the Corporation consisting of persons who are not at that time parties to the action, suit or proceeding in question (“disinterested directors”), whether or not a quorum, (b) by a committee of disinterested directors designated by majority vote of disinterested directors, whether or not a quorum, (c) if there are no disinterested directors, or if the disinterested directors so direct, by independent legal counsel (who may, to the extent permitted by law, be regular legal counsel to the Corporation) in a written opinion, or (d) by the stockholders of the Corporation.
7. Remedies. The right to indemnification or advancement of expenses as granted by this Article EIGHTH shall be enforceable by Indemnitee in any court of competent jurisdiction. Neither the failure of the Corporation to have made a determination prior to the commencement of such action that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Corporation pursuant to Section 6 of this Article EIGHTH that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct. In any suit brought by Indemnitee to enforce a right to indemnification, or brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Corporation shall have the burden of proving that Indemnitee is not entitled to be indemnified, or to such advancement of expenses, under this Article EIGHTH. Indemnitee’s expenses (including attorneys’ fees) reasonably incurred in connection with successfully establishing Indemnitee’s right to indemnification, in whole or in part, in any such proceeding shall also be indemnified by the Corporation. Notwithstanding the foregoing, in any suit brought by Indemnitee to enforce a right to indemnification hereunder it shall be a defense that the Indemnitee has not met any applicable standard for indemnification set forth in the General Corporation Law of the State of Delaware.
8. Limitations. Notwithstanding anything to the contrary in this Article EIGHTH, except as set forth in Section 7 of this Article EIGHTH, the Corporation shall not indemnify an Indemnitee pursuant to this Article EIGHTH in connection with a proceeding (or part thereof) initiated by such Indemnitee unless the initiation thereof was approved by the Board of Directors. Notwithstanding anything to the contrary in this Article EIGHTH, the Corporation shall not indemnify an Indemnitee to the extent such Indemnitee is reimbursed from the proceeds of insurance, and in the event the Corporation makes any indemnification payments to an Indemnitee and such Indemnitee is subsequently reimbursed from the proceeds of insurance, such Indemnitee shall promptly refund indemnification payments to the Corporation to the extent of such insurance reimbursement.
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9. Subsequent Amendment. No amendment, termination or repeal of this Article EIGHTH or of the relevant provisions of the General Corporation Law of the State of Delaware or any other applicable laws shall adversely affect or diminish in any way the rights of any Indemnitee to indemnification under the provisions hereof with respect to any action, suit, proceeding or investigation arising out of or relating to any actions, transactions or facts occurring prior to the final adoption of such amendment, termination or repeal.
10. Other Rights. The indemnification and advancement of expenses provided by this Article EIGHTH shall not be deemed exclusive of any other rights to which an Indemnitee seeking indemnification or advancement of expenses may be entitled under any law (common or statutory), agreement or vote of stockholders or disinterested directors or otherwise, both as to action in Indemnitee’s official capacity and as to action in any other capacity while holding office for the Corporation, and shall continue as to an Indemnitee who has ceased to be a director or officer, and shall inure to the benefit of the estate, heirs, executors and administrators of Indemnitee. Nothing contained in this Article EIGHTH shall be deemed to prohibit, and the Corporation is specifically authorized to enter into, agreements with officers and directors providing indemnification rights and procedures different from those set forth in this Article EIGHTH. In addition, the Corporation may, to the extent authorized from time to time by its Board of Directors, grant indemnification rights to other employees or agents of the Corporation or other persons serving the Corporation and such rights may be equivalent to, or greater or less than, those set forth in this Article EIGHTH.
11. Partial Indemnification. If an Indemnitee is entitled under any provision of this Article EIGHTH to indemnification by the Corporation for some or a portion of the expenses (including attorneys’ fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974) or amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with any action, suit, proceeding or investigation and any appeal therefrom but not, however, for the total amount thereof, the Corporation shall nevertheless indemnify Indemnitee for the portion of such expenses (including attorneys’ fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974) or amounts paid in settlement to which Indemnitee is entitled.
12. Insurance. The Corporation may purchase and maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) against any expense, liability or loss incurred by him or her in any such capacity, or arising out of his or her status as such, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the General Corporation Law of the State of Delaware.
13. Savings Clause. If this Article EIGHTH or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each Indemnitee as to any expenses (including attorneys’ fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974) and amounts paid in settlement in connection with any action, suit, proceeding or investigation, whether civil, criminal or administrative, including an action by or
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in the right of the Corporation, to the fullest extent permitted by any applicable portion of this Article EIGHTH that shall not have been invalidated and to the fullest extent permitted by applicable law.
14. Definitions. Terms used herein and defined in Section 145(h) and Section 145(i) of the General Corporation Law of the State of Delaware shall have the respective meanings assigned to such terms in such Section 145(h) and Section 145(i).
NINTH: This Article NINTH is inserted for the management of the business and for the conduct of the affairs of the Corporation.
1. General Powers. The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors.
2. Number of Directors; Election of Directors. Subject to the rights of holders of any series of Preferred Stock to elect directors, the number of directors of the Corporation shall be established by the Board of Directors. Election of directors need not be by written ballot, except as and to the extent provided in the By-laws of the Corporation.
3. Classes of Directors. Subject to the rights of holders of any series of Preferred Stock to elect directors, the Board of Directors shall be and is divided into three classes, designated Class I, Class II and Class III. Each class shall consist, as nearly as may be possible, of one-third of the total number of directors constituting the entire Board of Directors. The Board of Directors is authorized to assign members of the Board of Directors already in office to Class I, Class II or Class III at the time such classification becomes effective.
4. Terms of Office. Subject to the rights of holders of any series of Preferred Stock to elect directors, each director shall serve for a term ending on the date of the third annual meeting of stockholders following the annual meeting of stockholders at which such director was elected; provided that each director initially assigned to Class I shall serve for a term expiring at the Corporation’s first annual meeting of stockholders held after the effectiveness of this Restated Certificate of Incorporation; each director initially assigned to Class II shall serve for a term expiring at the Corporation’s second annual meeting of stockholders held after the effectiveness of this Restated Certificate of Incorporation; and each director initially assigned to Class III shall serve for a term expiring at the Corporation’s third annual meeting of stockholders held after the effectiveness of this Restated Certificate of Incorporation; provided further, that the term of each director shall continue until the election and qualification of his or her successor and be subject to his or her earlier death, resignation or removal.
5. Quorum. The greater of (a) a majority of the directors at any time in office and (b) one-third of the number of directors fixed pursuant to Section 2 of this Article NINTH shall constitute a quorum of the Board of Directors. If at any meeting of the Board of Directors there shall be less than such a quorum, a majority of the directors present may adjourn the meeting from time to time without further notice other than announcement at the meeting, until a quorum shall be present.
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6. Action at Meeting. Every act or decision done or made by a majority of the directors present at a meeting duly held at which a quorum is present shall be regarded as the act of the Board of Directors unless a greater number is required by law or by this Certificate of Incorporation.
7. Removal. Subject to the rights of holders of any series of Preferred Stock, directors of the Corporation may be removed only for cause and only by the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors.
8. Vacancies. Subject to the rights of holders of any series of Preferred Stock, any vacancy or newly created directorship in the Board of Directors, however occurring, shall be filled only by vote of a majority of the directors then in office, although less than a quorum, or by a sole remaining director and shall not be filled by the stockholders. A director elected to fill a vacancy shall hold office until the next election of the class for which such director shall have been chosen, subject to the election and qualification of a successor and to such director’s earlier death, resignation or removal.
9. Stockholder Nominations and Introduction of Business, Etc. Advance notice of stockholder nominations for election of directors and other business to be brought by stockholders before a meeting of stockholders shall be given in the manner provided by the By-laws of the Corporation.
10. Amendments to Article. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article NINTH.
TENTH: Stockholders of the Corporation may not take any action by written consent in lieu of a meeting. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article TENTH.
ELEVENTH: Special meetings of stockholders for any purpose or purposes may be called at any time by only the Board of Directors, the Chairman of the Board of Directors or the Chief Executive Officer of the Corporation, and may not be called by any other person or persons. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would
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be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article ELEVENTH.
IN WITNESS WHEREOF, this Restated Certificate of Incorporation, which restates, integrates and amends the certificate of incorporation of the Corporation, and which has been duly adopted in accordance with Sections 228, 242 and 245 of the General Corporation Law of the State of Delaware, has been executed by its duly authorized officer this 12th day of November, 2013.
| KARYOPHARM THERAPEUTICS INC. | ||
| By: | /s/ Michael Kauffman | |
| Name: Michael Kauffman, M.D., Ph.D. | ||
| Title: President and Chief Executive Officer | ||
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CERTIFICATE OF AMENDMENT OF
RESTATED CERTIFICATE OF INCORPORATION
OF
KARYOPHARM THERAPEUTICS INC.
(Pursuant to Section 242 of the
General Corporation Law of the State of Delaware)
Karyopharm Therapeutics Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware, does hereby certify as follows:
A resolution was duly adopted by the Board of Directors of the Corporation pursuant to Section 242 of the General Corporation Law of the State of Delaware setting forth a proposed amendment to the Restated Certificate of Incorporation of the Corporation and declaring said amendment to be advisable. The stockholders of the Corporation duly approved said proposed amendment in accordance with Section 242 of the General Corporation Law of the State of Delaware. The resolution setting forth the amendment is as follows:
| RESOLVED: |
That the first sentence of Article FOURTH of the Restated Certificate of Incorporation of the Corporation be and hereby is deleted in its entirety and the following is inserted in lieu thereof: |
“FOURTH: The total number of shares of all classes of stock which the Corporation shall have the authority to issue is 205,000,000 shares, consisting of (i) 200,000,000 shares of Common Stock, $0.0001 par value per share (“Common Stock”), and (ii) 5,000,000 shares of Preferred Stock, $0.0001 par value per share (“Preferred Stock”).”
***
IN WITNESS WHEREOF, this Certificate of Amendment has been executed by a duly authorized officer of the Corporation on this 6th day of June, 2019.
| KARYOPHARM THERAPEUTICS INC. | ||
| By: /s/ Michael Kauffman | ||
| Michael Kauffman, M.D., Ph.D. | ||
| Chief Executive Officer | ||
Exhibit 31.1
CERTIFICATIONS
I, Michael Kauffman, M.D., Ph.D., certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Karyopharm Therapeutics Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| /s/ MICHAEL KAUFFMAN |
| Michael Kauffman, M.D., Ph.D. |
| Chief Executive Officer |
| (Principal executive officer) |
Date: August 7, 2019
Exhibit 31.2
CERTIFICATIONS
I, Michael Mason, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Karyopharm Therapeutics Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| /s/ MICHAEL MASON |
| Michael Mason |
| Senior Vice President, Chief Financial Officer and Treasurer |
| (Principal financial and accounting officer) |
Date: August 7, 2019
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Karyopharm Therapeutics Inc. (the “Company”) for the period ended June 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Michael Kauffman, M.D., Ph.D., Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
| (1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| /s/ MICHAEL KAUFFMAN |
| Michael Kauffman, M.D., Ph.D. |
| Chief Executive Officer |
| (Principal executive officer) |
Date: August 7, 2019
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Karyopharm Therapeutics Inc. (the “Company”) for the period ended June 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Michael Mason, Senior Vice President, Chief Financial Officer and Treasurer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
| (1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| /s/ MICHAEL MASON |
| Michael Mason |
| Senior Vice President, Chief Financial Officer and Treasurer |
| (Principal financial and accounting officer) |
Date: August 7, 2019
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Jun. 30, 2019 |
Dec. 31, 2018 |
|---|---|---|
| Statement of Financial Position [Abstract] | ||
| Preferred stock, par value | $ 0.0001 | $ 0.0001 |
| Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
| Preferred stock, shares issued | 0 | 0 |
| Preferred stock, shares outstanding | 0 | 0 |
| Common stock, par value | $ 0.0001 | $ 0.0001 |
| Common stock, shares authorized | 200,000,000 | 100,000,000 |
| Common stock, shares issued | 60,965,505 | 60,829,308 |
| Common stock, shares outstanding | 60,965,505 | 60,829,308 |
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
| Income Statement [Abstract] | ||||
| License and other revenue | $ 9,493 | $ 19,891 | $ 9,648 | $ 29,891 |
| Operating expenses: | ||||
| Research and development | 26,517 | 44,734 | 64,491 | 86,055 |
| General and administrative | 24,662 | 9,489 | 51,765 | 17,110 |
| Total operating expenses | 51,179 | 54,223 | 116,256 | 103,165 |
| Loss from operations | (41,686) | (34,332) | (106,608) | (73,274) |
| Other income (expense): | ||||
| Interest income | 1,412 | 653 | 3,183 | 1,162 |
| Interest expense | (3,089) | (6,087) | ||
| Other (expense) income | (44) | 7 | (46) | (7) |
| Total other (expense) income, net | (1,721) | 660 | (2,950) | 1,155 |
| Loss before income taxes | (43,407) | (33,672) | (109,558) | (72,119) |
| Income tax (provision) benefit | (8) | 17 | (18) | 5 |
| Net loss | $ (43,415) | $ (33,655) | $ (109,576) | $ (72,114) |
| Net loss per share—basic and diluted | $ (0.71) | $ (0.60) | $ (1.80) | $ (1.36) |
| Weighted-average number of common shares outstanding used in net loss per share—basic and diluted | 60,929,024 | 56,089,159 | 60,892,860 | 52,862,194 |
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
| Statement of Comprehensive Income [Abstract] | ||||
| Net loss | $ (43,415) | $ (33,655) | $ (109,576) | $ (72,114) |
| Comprehensive income (loss) | ||||
| Unrealized gain (loss) on investments | 52 | 104 | 309 | (5) |
| Foreign currency translation adjustments | 37 | (78) | (4) | (38) |
| Comprehensive loss | $ (43,326) | $ (33,629) | $ (109,271) | $ (72,157) |
Summary of Significant Accounting Policies |
6 Months Ended |
|---|---|
Jun. 30, 2019 | |
| Accounting Policies [Abstract] | |
| Summary of Significant Accounting Policies | 1. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements of Karyopharm Therapeutics Inc., a Delaware corporation (the “Company”), have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and six months ended June 30, 2019 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2019. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the Securities and Exchange Commission (“SEC”) on February 28, 2019.In July 2019, the U.S. Food and Drug Administration (“FDA”) approved XPOVIO TM At June 30, 2019, the Company had $217,159 in cash, cash equivalents and investments. The Company has had recurring losses and incurred a loss of $109,576 for the six months ended June 30, 2019. Net cash used in operations for the six months ended June 30, 2019 was $114,827. The Company expects that its cash, cash equivalents and investments at June 30, 2019 will be sufficient to fund current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of these financial statements , during which time the Company plans to continue to commercialize XPOVIO in the United States , which commenced in July 2019. Basis of Consolidation The condensed consolidated financial statements at June 30, 2019 include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The significant accounting policies used in preparation of these condensed consolidated financial statements on Form 10-Q for the six months ended June 30, 2019 are consistent with those discussed in Note 2 to the financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, except as it relates to the adoption of new accounting standards during the first six months of 2019 as discussed below. |
Recent Accounting Pronouncements |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Accounting Changes and Error Corrections [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Recent Accounting Pronouncements | 2. Recent Accounting Pronouncements Recently Adopted Accounting Standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) 2016-02”). ASU 2016-02 supersedes the lease guidance under FASB ASC Topic 840, Leases Leases right-of-use assets, representing the right to use the underlying asset for the lease term for both finance and operating leases, and (ii) disclose qualitative and quantitative information about its leasing arrangements.In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases (“ASU 2018-10”) and ASU No. 2018-11, Leases (Topic 842) Targeted Improvements (“ASU 2018-11”). The amendments in ASU 2018-10 and ASU 2018-11 provide additional clarification and implementation guidance on certain aspects of ASU 2016-02 and have the same effective and transition requirements as ASU 2016-02, as detailed below. ASU 2018-11 provides entities the option to not provide comparative period financial statements and instead apply the transition requirements as of the effective date of ASU 2016-02.ASU 2016-02, ASU 2018-10, and ASU 2018-11 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. Early adoption is permitted. The Company adopted the standard effective January 1, 2019 using the optional transition method under ASU 2018-11 and, therefore, prior period financial information has not been retrospectively adjusted. Pursuant to the guidance under ASU 2016-02, the Company elected the optional package of practical expedients to leases that commenced prior to the effective date, which allowed 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 elected, including: (i) a policy to not record right-of-use assets and leases on the balance sheet for short-term leases that qualify and (ii) a policy to not separate lease and non-lease components for certain classes of underlying assets on contracts entered into or modified after the effective date. The Company did not elect the use of hindsight in estimating the lease term for leases subject to transition to the new standard. As summarized in the table below, the standard had a material impact on the Company’s condensed consolidated balance sheet as of June 30, 2019, specifically through recognition of right-of-use assets of $11,711 and lease liabilities of $16,023 for the Company’s existing operating lease for office space in Newton, MA on the effective date. The difference between the operating lease right-of-use assets and operating lease liabilities is due to the change in classification of deferred rent and lease incentives, as recorded on the Company’s condensed consolidated balance sheets through December 31, 2018, from liabilities to reduction in the Company’s operating lease right-of-use assets. However, the standard did not have a material impact on the Company’s condensed consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2019, as expense for the Company’s existing operating leases continues to be recognized consistent with the recognition pattern before adoption of the new standard. Please refer to Note 8, “Leases” for further information.
The Company implemented internal controls to enable the preparation of financial information upon adoption. In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting 2018-07”). ASU 2018-07 largely aligns the accounting for share-based payment awards issued to employees and nonemployees by expanding the scope of Topic 718 to apply to nonemployee share-based transactions, as long as the transaction is not effectively a form of financing. The new guidance was adopted on January 1, 2019 and it did not have a material impact on the Company’s condensed consolidated financial statements.In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements 2018-09”). This amendment makes changes to a variety of topics to clarify, correct errors in, or make minor improvements to the Accounting Standards Codification. The amendments are effective for annual periods beginning after December 15, 2018 and were adopted effective January 1, 2019. The adoption of these amendments did not have a material impact on the Company’s condensed consolidated financial statements.In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606 2018-18”). The amendments in ASU 2018-18 clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606, Revenue from Contracts with Customers 2018-18 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The amendments in ASU 2018-18 should be applied retrospectively to the date of initial application of ASC 606. The Company adopted this guidance effective January 1, 2019 using the modified retrospective approach. The adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements, as each of the Company’s arrangements detailedbelow within Note 3, “License and Asset Purchase Agreements,” were previously accounted for under ASC 606, not ASC 808, and the Company has no other arrangements within the scope of ASC 808. On August 17, 2018, the SEC issued an amendment to Rule 3-04 of Regulation S-X, which extended the annual disclosure requirement of reporting changes in stockholders’ equity to interim periods. Such disclosures are to be provided in a note to the financial statements or in a separate financial statement and requires both the year-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 date of the requirement. Under the guidance in C&DI 105.09, the Company implemented this updated disclosure requirement beginning with the Form 10-Q for the quarterly period ended March 31, 2019, specifically through inclusion of the comparative condensed consolidated statements of stockholders’ equity. Recently Issued Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2019. The Company is currently evaluating the effects the adoption of ASU 2016-13 will have on its consolidated financial statements and related disclosures.In August 2018, the FASB issued ASU No. 2018-13, F air Value Measurement—Disclosure Framework-Changes to the Disclosure Requirement for Fair Value Measurement 2018-13”). The amendments in ASU 2018-13 modify the disclosure requirements on fair value measurements in ASC 820, Fair Value Measurement, based on the concepts in the FASB Concepts Statement, including the consideration of costs and benefits. The amendments under ASU 2018-13 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company is currently evaluating the effects the adoption of ASU 2018-13 will have on its consolidated financial statements and related disclosures.In August 2018, the FASB issued ASU No. 2018-15, Intangible-Goodwill and Other Internal-Use Software (Subtopic 350-40) 2018-15”). 2018-15 updates guidance regarding accounting for implementation costs associated with a cloud computing arrangement that is a service contract. The amendments under ASU 2018-15 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption of ASU 2018-15 to have a material impact on its consolidated financial statements. |
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License and Asset Purchase Agreements |
6 Months Ended |
|---|---|
Jun. 30, 2019 | |
| Revenue from Contract with Customer [Abstract] | |
| License and Asset Purchase Agreements | 3. License and Asset Purchase Agreements Antengene License Agreement Effective May 23, 2018 (the “Antengene Effective Date”), the Company entered into a License Agreement (“Antengene License Agreement”) with Antengene Therapeutics Limited, a corporation organized and existing under the laws of Hong Kong (“Antengene”) and a subsidiary of Antengene Corporation Co. Ltd., a corporation organized and existing under the laws of the People’s Republic of China, pursuant to which the Company granted Antengene exclusive rights to develop and commercialize, at its own cost, (i) selinexor, the Company’s lead, novel, oral Selective Inhibitor of Nuclear Export (“SINE”) compound, (ii) eltanexor, the Company’s second-generation oral SINE compound, and (iii) KPT-9274, the Company’s first-in-class orally bioavailable small molecule that is a non-competitive dual modulator of PAK4 and NAMPT, each for the diagnosis, treatment and/or prevention of all human oncology indications (the “Oncology Field”), as well as (iv) verdinexor, the Company’s lead compound in development for the treatment of viral indications for the diagnosis, treatment and/or prevention of certain human non-oncology indications (the “Non-Oncology Field”) (the “Antengene Licensed Compounds”). The Company licensed the development and commercial rights to Antengene for selinexor and eltanexor in the Oncology Field in mainland China and Macau and licensed the development and commercial rights to Antengene for KPT-9274 in the Oncology Field and verdinexor in the Non-Oncology Field in mainland China, Taiwan, Hong Kong, Macau, South Korea, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam (the “Antengene Territory”).Pursuant to the terms of the Antengene License Agreement, the Company received an upfront payment of $11,703, and could receive up to $105,000 in milestone payments if certain development goals are achieved and up to $45,000 in milestone payments if certain sales milestones are achieved, as well as a high single-digit to low double-digit royalty based on future net sales of the Antengene Licensed Compounds in the Antengene Territory. In addition, upon Antengene’s election and the parties’ full execution of a manufacturing technology transfer plan and satisfaction of other specified conditions (the “Antengene Manufacturing Election”), the Company will grant to Antengene non-exclusive rights to manufacture the Antengene Licensed Compounds and products containingsuch compounds in or outside of the Antengene Territory solely for development and commercialization in the fields in the Antengene Territory. As part of the Antengene License Agreement, Antengene will also have the right to participate in global clinical studies of the Antengene Licensed Compounds and will bear the cost and expense for patients enrolled in clinical studies in the Antengene Territory. Antengene is responsible for seeking regulatory and marketing approvals for the Antengene Licensed Compounds in the Antengene Territory, as well as any development of the products specifically necessary to obtain such approvals. Antengene is also responsible for the commercialization of the Antengene Licensed Compounds in the Oncology Field and Non-Oncology Field, as applicable, in the Antengene Territory at its own cost and expense.Until such time as Antengene elects to manufacture its own drug substance, the Company will furnish clinical supplies of drug substance to Antengene for use in Antengene’s development efforts pursuant to a clinical supply agreement to be entered into by the Company and Antengene, and Antengene may elect to have the Company provide commercial supplies of drug product to Antengene pursuant to a commercial supply agreement to be entered into by the Company and Antengene, in each case the costs of which will be borne by Antengene. The Antengene License Agreement will continue in effect on a product-by-product, country-by-country basis until the later of the tenth anniversary of the first commercial sale of the applicable product in such country or the expiration of specified patent protection and regulatory exclusivity periods for the applicable product in such country. However, the Antengene License Agreement may be terminated earlier by (i) either party for breach of the Antengene License Agreement by the other party or in the event of the insolvency or bankruptcy of the other party, (ii) Antengene on a product-by-product basis for certain safety reasons or on a product-by-product, country-by-country basis for any reason with 180 days’ prior notice or (iii) the Company in the event Antengene challenges or assists with a challenge to certain of the Company’s patent rights. The Company assessed the Antengene arrangement in accordance with ASC 606 and concluded that the contract counterparty, Antengene, is a customer. The Company identified the following material promises under the contract: (i) exclusive licenses for each Antengene Licensed Compound, (ii) initial data transfers for each Antengene Licensed Compound, which consisted of regulatory data compiled by the Company for the Antengene Licensed Compounds as of the Antengene Effective Date, and (iii) obligations to stand-ready to provide an initial clinical supply for each Antengene Licensed Compound. The Company also identified immaterial promises under the contract relating to information exchanges and participation on operating committees and other working groups. Separately, the Company also identified certain customer options that would create an obligation for the Company if exercised by Antengene, including (i) additional data transfers for each Antengene Licensed Compound, which would consist of the transfer of additional regulatory data compiled by the Company for each Antengene Licensed Compound after the Antengene Effective Date, (ii) obligations to provide additional clinical supply and related substance supply for each Antengene Licensed Compound upon request by Antengene, (iii) manufacturing technology transfers and licenses for each Antengene Licensed Compound under the Antengene Manufacturing Election, as detailed above, and (iv) options for a backup compound, which represents Antengene’s option to select a replacement compound in the event it elects to discontinue the development of the Antengene Licensed Compounds (the “Antengene Transfer Options”). The Antengene Transfer Options individually represent material rights, as they were offered at a significant and incremental discount. Therefore, they were further assessed as performance obligations under the Antengene License Agreement. Finally, the Company also identified certain other customer options that would create a manufacturing obligation for the Company if exercised by Antengene, including for commercial supply. These options do not represent a material right, as they are not offered at a significant and incremental discount. In further evaluating the promises detailed above, the Company determined that the exclusive licenses, initial data transfers, and stand-ready obligation to provide initial clinical supply for each Antengene Licensed Compound were not distinct from one another, and must be combined as four separate performance obligations (the “Antengene Combined License Obligation for selinexor”, “Antengene Combined License Obligation for eltanexor”, “Antengene Combined License Obligation for KPT-9274” and “Antengene Combined License Obligation for verdinexor”). This is because, for each Antengene Licensed Compound, Antengene requires the initial data transfer and initial clinical supply to derive benefit from the exclusive licenses, since the Company did not grant manufacturing licenses to any of the Antengene Licensed Compounds at contract inception. The Company also determined that each of the Antengene Transfer Options represents a distinct performance obligation. Based on these determinations, the Company identified eight performance obligations at the inception of the Antengene License Agreement, including (i) the Antengene Combined License Obligation for selinexor, (ii) the Antengene Combined License Obligation for eltanexor, (iii) the Antengene Combined License Obligation for KPT-9274, (iv) the Antengene Combined License Obligation for verdinexor, and the four components of the Antengene Transfer Options, including (v) the material right for additional data transfer, (vi) the material right for additional clinical supply and related substance supply, (vii) the material right for manufacturing technology transfer and license, and (viii) the material right for the option for a backup compound. The Company further determined that the up-front payment of $11,703 constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the performance obligations based on their relative stand-alone selling prices. The Company determined that substantially all of the total standalone selling price in the arrangement is derived from the four Antengene Combined License Obligations for selinexor, eltanexor, KPT-9274 and verdinexor. In connection therewith, the Company also estimated the standalone selling price for each of the material rights within the Antengene Transfer Options, and determined that such amounts were insignificant, and, therefore, immaterial for purposes of allocation. Accordingly, the Company allocated the $11,703 transaction price amongst the Antengene Combined License Obligations as follows: $9,362 for selinexor, $1,054 for eltanexor, $1,053 for KPT-9274, and $234 for verdinexor. The Company believes that a change in the assumptions used to determine its best estimate of the stand-alone selling prices for any of the identified performance obligations would not have a significant effect on the allocation of the underlying transaction price to the performance obligations.Upon execution of the Antengene License Agreement, the only fixed component of the transaction price included the $11,703 up-front payment owed to the Company. As referenced above, the Company is eligible to receive additional payments of up to $105,000 in milestone payments if certain development goals are achieved and up to $45,000 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 Company 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 June 30, 2019, because the amounts were fully constrained as of June 30, 2019. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of such amounts is outside the control of the Company. 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’s accounting policy. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur.During the three months ended June 30, 2019, the Company recognized $9,362 in revenue under the Antengene License Agreement, as the Antengene Combined License Obligation for selinexor was satisfied when the initial clinical supply of selinexor was delivered during this period. Revenue will be recognized for the Antengene Combined License Obligation for eltanexor, the Antengene Combined License Obligation for KPT-9274, and the Antengene Combined License Obligation for verdinexor once the Company’s promise to provide initial clinical supply of each of the Antengene Licensed Compounds in the future is fulfilled. The Company currently expects such promises to be fulfilled within the next twelve months, except for the initial clinical supply of eltanexor, which is expected to occur in the third quarter of 2020. Accordingly, and as of June 30, 2019, the remaining $2,341 of the upfront payment represents a contract liability, (i) $1,287 of which was included in deferred revenue and is classified as a current liability in the condensed consolidated balance sheet and (ii) $1,054 of which was included in deferred revenue and is classified as a non-current liability in the condensed consolidated balance sheet.Biogen Asset Purchase Agreement On January 24, 2018, the Company entered into an Asset Purchase Agreement (the “APA”) and Letter Agreement with Biogen MA Inc., a Massachusetts corporation and subsidiary of Biogen, Inc. (“Biogen”). Under the terms of the APA and Letter Agreement, the Company sold to Biogen exclusive worldwide rights to develop and commercialize the Company’s oral SINE compound KPT-350 and certain related assets with an initial focus in amyotrophic lateral sclerosis (“ALS”) (the “Transfer of IP”), and also granted Biogen: (i) an exclusive worldwide license under certain of the Company’s intellectual property to manufacture or have manufactured KPT -350 (the “Manufacturing License”), (ii) a technology transfer package, consisting of information and the Company’s know-how regarding the manufacture of KPT-350 (the “Manufacturing Technology Transfer”), (iii) a right, at Biogen’s request, to have the Company provide transition assistance regarding manufacturing and other matters (the “Transition Assistance”), (iv) existing inventory of KPT-350 (the “Inventory”), (v) an initial supply of KPT-350 (the “Initial Supply”), and (vi) a right, at Biogen’s request, to have the Company manufacture and supply the active pharmaceutical ingredient for an additional supply of KPT-350 (the “Additional Supply”). In consideration for these rights, the Company received an upfront payment of $10,000, and is eligible to receive additional payments of up to $142,000 based on the achievement by Biogen of future specified development milestones, and up to $65,000 based on the achievement by Biogen of future specified commercial milestones. The Company will also be 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 a country-by-country basis.The Company and Biogen have made customary representations and warranties and agreed to customary covenants in the APA, including covenants requiring Biogen to use commercially reasonable efforts to develop KPT-350 in specified neurological indications, including ALS, in any of the United States, United Kingdom, France, Spain, Germany or Italy. The APA will continue in effect until the expiration of all royalty obligations, provided that the APA may be terminated earlier by Biogen, subject to the requirements that Biogen (i) negotiate in good faith with the Company regarding an assignment or license back to the Company of the purchased assets and (ii) not transfer or license the purchased assets to a third party unless such third party assumes Biogen’s obligations to the Company under the APA.The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Biogen, is a customer. The Company identified the following material promises in the arrangement: the Transfer of IP and the Manufacturing License. The Company also identified immaterial promises under the contract that were not deemed performance obligations. The Company further determined that other promises for Additional Supply and Transition Assistance represented customer options, which would create an obligation for the Company if exercised by Biogen. Since no additional or material consideration is owed to the Company by Biogen upon exercise of the customer options for Additional Supply and Transition Assistance, the Company determined that both are offered at significant and incremental discounts. Accordingly, they were assessed as material rights and, therefore, separate performance obligations in the arrangement. The Company 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 Company 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 further determined that the up-front payment of $10,000 constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the performance obligations based on their relative stand-alone selling prices. In connection therewith, the Company 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 Company 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 Company determined that substantially all of the $10,000 transaction price should be allocated to the Combined Performance Obligation. The Company believes that a change in the assumptions used to determine its 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.Upon execution of the APA, the transaction price included only the $10,000 up-front payment owed to the Company. The Company may receive further payments upon the achievement of certain regulatory and sales milestones, as detailed above, as well as tiered royalty payments that reach low double-digits based on future net sales. The future regulatory milestones, which represent variable consideration, were evaluated under the most likely amount method, and were not included in the transaction price, because the amounts were fully constrained as of June 30, 2019. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of such milestones is outside the control of the Company. Separately, any consideration related to sales-based milestones, as well as royalties on net sales upon commercialization by Biogen, will be recognized when the related sales occur, as they were determined to relate predominantly to the intellectual property and, therefore, have also been excluded from the transaction price in accordance with the sales-based royalty exception, as well as the Company’s accounting policy. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur.The Company recognized $10,000 of revenue during the first quarter of 2018, which was when it had satisfied its promises under the Combined Performance Obligation by transferring the underlying promised goods. Ono License Agreement Effective October 11, 2017 (the “Ono Effective Date”), the Company entered into a license agreement (the “Ono License Agreement”) with Ono Pharmaceutical Co., Ltd., a corporation organized and existing under the laws of Japan (“Ono”), pursuant to which the Company 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 (the “Ono Field”) 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 (the “Ono Territory”) (the “Ono Exclusive License”). Pursuant to the terms of the Ono License Agreement, the Company received an upfront payment of ¥2.5 billion (US$21,916 on the date received), and could receive up to ¥10.15 billion (approximately US$90,500 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 (approximately US$80,200 at the exchange rate as of the Ono Effective Date) in milestone payments ifcertain sales milestones are achieved, as well as a low double-digit royalty based on future net sales of selinexor and eltanexor in the Ono Territory. In addition, upon Ono’s election and the parties’ full execution of a manufacturing technology transfer plan and satisfaction of other specified conditions (the “Ono Manufacturing Election”), the Company will grant to Ono non-exclusive rights to manufacture selinexor, eltanexor and products containing such compounds in or outside of the Ono Territory solely for development and commercialization in the Ono Field in the Ono Territory.As part of the Ono License Agreement, Ono will also have the right to participate in global clinical studies of selinexor and eltanexor and will bear the cost and expense for patients enrolled in clinical studies in the Ono Territory. Ono is responsible for seeking regulatory and marketing approvals for selinexor and eltanexor in the Ono Territory, as well as any development of the products specifically necessary to obtain such approvals. Ono is also responsible for the commercialization of products containing selinexor or eltanexor in the Ono Field in the Ono Territory at its own cost and expense. Subject to the Ono Manufacturing Election, the Company will furnish clinical supplies of drug substance to Ono for use in Ono’s development efforts pursuant to a clinical supply agreement to be entered into by the Company and Ono, and Ono may elect to have the Company provide commercial supplies of drug product to Ono pursuant to a commercial supply agreement to be entered into by the Company and Ono, in each case the costs of which will be borne by Ono. The Ono License Agreement will continue in effect on a product-by-product, country-by-country basis until the later of the tenth anniversary of the first commercial sale of the applicable product in such country or the expiration of specified patent protection and regulatory exclusivity periods for the applicable product in such country. However, the Ono License Agreement may be terminated earlier by (i) either party for breach of the Ono License Agreement by the other party or in the event of the insolvency or bankruptcy of the other party, (ii) Ono on a product-by-product basis for certain safety reasons or on a product-by-product, country-by-country basis for any reason with 180 days’ prior notice or (iii) the Company in the event Ono challenges or assists with a challenge to certain of the Company’s patent rights. The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Ono, is a customer. The Company identified the following material promises under the contract: (i) the Ono Exclusive License for selinexor and eltanexor, (ii) initial data transfer for selinexor and eltanexor, which consisted of regulatory data compiled by the Company for the licensed compounds and products as of the Ono Effective Date, (iii) initial clinical supply for selinexor, which consisted of units of clinical supply for Ono to conduct its Phase I Trial, and (iv) an obligation to stand-ready to provide initial clinical supply for eltanexor. The Company also identified immaterial promises under the contract relating to information exchanges, and participation on operating committees and other working groups. Separately, the Company also identified certain customer options that would create an obligation for the Company if exercised by Ono, including the (i) additional data transfer for selinexor and eltanexor, which would consist of the transfer of additional regulatory data compiled by the Company for the licensed compounds and products after the Ono Effective Date, (ii) additional clinical supply and related substance supply for selinexor and eltanexor, which would consist of supplying Ono with units and substance of selinexor and eltanexor incremental to the initial clinical supply for selinexor and the obligation to stand-ready to provide initial clinical supply for eltanexor, as noted above, (iii) manufacturing technology transfer and license for selinexor and eltanexor under the Ono Manufacturing Election, as detailed above, and (iv) options for a backup compound, which represents Ono’s option to select a replacement compound in the event it elects to discontinue the development of either of the licensed compounds (the “Ono Transfer Options”). The Ono Transfer Options individually represent material rights, as they were offered at a significant and incremental discount. Therefore, they were further assessed as performance obligations under the Ono License Agreement. The Company also identified certain other customer options that would create a manufacturing obligation for the Company if exercised by Ono, including commercial supply. This option is referred to herein as the “Ono Manufacturing Option.” The Ono Manufacturing Option does not represent a material right, as it is not offered at a significant and incremental discount. In further evaluating the promises detailed above, the Company determined that the (i) Ono Exclusive License, initial data transfer, and initial clinical supply for selinexor and (ii) Ono Exclusive License, initial data transfer, and obligation to stand-ready to provide initial clinical supply of eltanexor were not distinct from one another, and must be combined as two separate performance obligations (the “Ono Combined License Obligation for selinexor” and the “Ono Combined License Obligation for eltanexor”). This is because, for both selinexor and eltanexor, Ono requires the initial data transfer and clinical supply to derive benefit from the Ono Exclusive License since the Company did not grant manufacturing licenses for selinexor and eltanexor at contract inception. The Company also determined that each of the Ono Transfer Options represents a distinct performance obligation. Based on these determinations, the Company identified six distinct performance obligations at the inception of the Ono License Agreement, including (i) the Ono Combined License Obligation for selinexor, (ii) the Ono Combined License Obligation for eltanexor, and the four components of the Ono Transfer Options, including (iii) the material right for additional data transfer, (iv) the material right for additional clinical supply and related substance supply, (iv) the material right for manufacturing technology transfer and license, and (vi) the material right for the option for a backup compound. The Company further determined that the up-front payment of ¥2.5 billion (US$21,916 on the date received) constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the performance obligations based on the Company’s best estimate of their relative stand-alone selling prices. The Company determined that substantially all of the total standalone selling price in the arrangement is derived from the Ono Combined License Obligation for selinexor and the Ono Combined License Obligation for eltanexor. In connection therewith, the Company estimated the standalone selling price for each of the material rights within the Ono Transfer Options, and determined that such amounts were insignificant, and, therefore, immaterial for purposes of allocation. Accordingly, the Company allocated the ¥2.5 billion (US$21,916 on the date received) upfront transaction price between the Ono Combined License Obligations as follows: $ 19,724 for selinexor and $ 2,192 for eltanexor. The Company believes that a change in the assumptions used to determine its best estimate of the stand-alone selling prices for any of the identified performance obligations would not have a significant effect on the allocation of the underlying transaction price to the performance obligations. Upon execution of the Ono License Agreement, the transaction price included only the ¥2.5 billion (US$21,916 on the date received) up-front payment owed to the Company. As referenced above, the Company is eligible to receive additional payments of up to ¥10.15 billion based on the achievement by Ono of future specified development milestones and up to ¥9 .0 billion based on the achievement by Ono of future specified commercial milestones, as well as a low double-digit royalty based on future net sales of selinexor and eltanexor in the Ono Territory. In addition, the Company could receive cost reimbursement in connection with its promise to stand-ready to provide initial clinical supply for eltanexor in the future. The future regulatory milestones and cost reimbursement for providing initial clinical supply of eltanexor, both of which represent variable consideration, were evaluated under the most likely amount method, and were not included in the transaction price, because the amounts were fully constrained as of June 30, 2019. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of such amounts is outside the control of the Company. 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’s accounting policy. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur.As the initial clinical supply of selinexor was delivered in April 2018, the Ono Combined License Obligation for selinexor was determined to be fulfilled and revenue of $19,724 was recognized during the quarter ended June 30, 2018. The transaction price allocated to the Ono Combined License Obligation for eltanexor will be recognized as revenue once the Company’s stand-ready promise to provide initial clinical supply of eltanexor in the future is fulfilled, which is the last remaining undelivered promise associated with the Ono Combined License Obligation for eltanexor. As of June 30, 2019, $2,192 of the Ono License Agreement upfront payment is included in deferred revenue and is classified as a non-current liability in the condensed consolidated balance sheet.Anivive License Agreement On April 28, 2017 (the “Anivive Effective Date”), the Company entered into a license agreement (the “Anivive Agreement”) with Anivive Lifesciences, Inc. (“Anivive”), a biopharmaceutical company engaged in the research, development and commercialization of animal health medicines, pursuant to which the Company has granted Anivive an exclusive, worldwide license to develop and commercialize verdinexor (KPT-335) for the treatment of cancer in companion animals (the “Anivive Exclusive License”). Pursuant to the terms of the Anivive Agreement, the Company received an upfront payment of $1,000 and a payment of $250 upon the completion of the technology transfer, which occurred during the year ended December 31, 2017. In addition, the Company is eligible to receive potential clinical, regulatory and commercial development milestone payments totaling up to $43,250, as well as a low double-digit royalty based on Anivive’s future net sales of verdinexor following commercialization. The potential future milestone payments are composed of $5,750 based on achievement of clinical and regulatory milestone events and $37,500 based on achievement of sales milestone events.The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Anivive, is a customer. The Company identified the following material promises under the contract, the Anivive Exclusive License and the technology transfer, which consisted of regulatory data compiled by the Company for the licensed compound and product as of the Anivive Effective Date. The Company also identified immaterial promises under the contract that were not deemed performance obligations, including participating on a product advisory committee and sharing regulatory matter information. The Company further determined that other promises for (i) transfer of additional technology in the future, if developed by the Company, and (ii) facilitating manufacturing and supply relationships with the Company’s third-party contract manufacturers represented customer options, would create an obligation for the Company if exercised by Anivive. Since no additional or immaterial consideration is owed to the Company by Anivive upon exercise of the customer options noted, the Company determined that both are offered at significant and incremental discounts. Accordingly, they were assessed as material rights and, therefore, separate performance obligations in the arrangement. In further evaluating the promises detailed above, the Company determined that the Anivive Exclusive License and the technology transfer were not distinct from one another and must be combined as a performance obligation (the “Anivive Combined License Obligation”). This is because Anivive requires the technology transfer to derive benefit from the Anivive Exclusive License. Based on these determinations, the Company identified three distinct performance obligations at the inception of the contract: (i) the Anivive Combined License Obligation, (ii) the material right for transfer of additional technology in the future, if developed by the Company, and (iii) the material right for facilitating manufacturing and supply relationships with the Company’s third-party contract manufacturers. The Company further determined that the up-front payment of $1,000 upon contract execution, as well as the $250 upon completion of the technology transfer, constituted the entirety of the consideration included in the transaction price as of the transition date, January 1, 2018, which was allocated to the performance obligations based on their relative stand-alone selling prices. In connection therewith, the Company estimated the stand-alone selling price of the (i) Anivive Combined License Obligation, (ii) material right for transfer of additional technology in the future, if developed by the Company, and (iii) the material right for facilitating manufacturing and supply relationships with the Company’s third-party contract manufacturers, and determined that the stand-alone selling price of the material rights noted were insignificant based on various qualitative considerations. Accordingly, the Company further determined that the allocation of the upfront payment to the material rights noted was insignificant. Based on the estimates of the stand-alone selling prices for each of the performance obligations, the Company determined that substantially all of the $1,250 transaction price should be allocated to the Anivive Combined License Obligation. The Company believes that a change in the assumptions used to determine its 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.As referenced above, the up-front payment of $1,000 upon contract execution, as well as the $250 upon completion of the technology transfer, constituted the entirety of the consideration included in the transaction price as of the transition date, January 1, 2018. The Company is also eligible to receive additional payments up to $5,750 based on achievement of clinical and regulatory milestone events and up to $37,500 based on achievement of sales milestone events, as well as a low double-digit royalty based on Anivive’s future net sales of verdinexor following commercialization. The future regulatory milestones, which represent variable consideration, were evaluated under the most likely amount method, and were not included in the transaction price, because the amounts are fully constrained as of June 30, 2019. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of such milestones is outside the control of the Company. Separately, any consideration related to sales-based milestones, as well as royalties on net sales upon commercialization by Anivive, will be recognized when the related sales occur, as they were determined to relate predominantly to the intellectual property granted to Anivive and, therefore, have also been excluded from the transaction price in accordance with the sales-based royalty exception, as well as the Company’s policy. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur.To date, the Company has recognized $1,250 of revenue associated with the Anivive Agreement. Revenue for the upfront payment and technology transfer milestone was recognized upon completion of the technology transfer in October 2017, as all promises under the Anivive Combined License Obligation had been fulfilled. |
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| Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value of Financial Instruments | 4. Fair Value of Financial Instruments Financial instruments, including cash, restricted cash, prepaid expenses and other current assets, accounts payable and accrued expenses are presented in the condensed consolidated financial statements at amounts that approximate fair value at June 30, 2019 and December 31, 2018. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:
Items classified as Level 2 within the valuation hierarchy consist of commercial paper, corporate debt securities, U.S. government agency securities and certificates of deposit. The Company estimates the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based approaches, for which al l significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar securities, issuer credit spreads, benchmark yields, and other observable inputs. The Company validates the prices provided by its third-party pricing sources by understanding the models used, obtaining market values from other pricing sources and analyzing pricing data in certain instances. The following table presents information about the Company’s financial assets that have been measured at fair value at June 30, 2019 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands):
The following table presents information about the Company’s financial assets that have been measured at fair value at December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands):
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| Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Investments | 5. Investments The following table summarizes the Company’s investments in debt securities, classified as
available-for-sale, as of June 30, 2019 (in thousands):
The following table summarizes the Company’s investments in debt securities, classified as
available-for-sale as of December 31, 2018 (in thousands):
At June 30, 2019 and December 31, 2018, the Company held 9 and 79 debt securities, respectively, that were in an unrealized loss position. The aggregate fair value of debt securities in an unrealized loss position at June 30, 2019 and December 31, 2018 was $19,713 and $180,627, respectively. As of June 30, 2019, two corporate debt securities with a fair value of $3,496 had been in a continuous unrealized loss position for more than 12 months. The unrealized loss of $4 related to these corporate debt securities are included in accumulated other comprehensive loss as of June 30, 2019. At June 30, 2019, the Company did not intend to sell the securities with an unrealized loss position in accumulated other comprehensive income, and it is not likely that the Company will be required to sell these securities before recovery of their amortized cost basis. The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary
impairments of investments are recognized in the condensed consolidated statements of operations if the Company has experienced a credit loss and has the intent to sell the investment or if it is more likely than not that the Company will be required to sell the investment before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. The unrealized losses at June 30, 2019 and December 31, 2018 are attributable to changes in interest rates and the Company does not believe any unrealized losses represent other-than-temporary impairments. |
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Net Loss Per Share |
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| Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss Per Share | 6. Net Loss Per Share Basic and diluted net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. The Company’s potentially dilutive shares, which include outstanding stock options and unvested restricted stock and restricted stock units, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
The Company has the option to settle the conversion obligation for its 3.00% convertible senior notes issued October 2018, and due , in cash, shares or any combination of the two. As such notes were not convertible as of June 30, 2019, they are not participating securities and do not have an impact on the calculation of basic earnings or loss per share. Based on the Company’s net loss position, there was no impact on the calculation of dilutive loss per share during the three and six months ended June 30, 2019. |
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Stock-based Compensation |
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| Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based Compensation | 7. Stock-based Compensation Stock Options A summary of the Company’s stock option activity and related information follows:
Total stock-based compensation expense related to stock options for the six months ended June 30, 2019 and 2018 was $6,772 and $8,169, respectively. As of June 30, 2019, there was $32,688 of total unrecognized stock-based compensation expense related to stock options. The expense is expected to be recognized over a weighted-average period of 2.9 years. Restricted Stock Units A restricted stock unit (“RSU”) represents the right to receive one share of the Company’s common stock upon vesting of the RSU. The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant. The Company grants RSUs with service conditions that vest in two or four equal annual installments provided that the employee remains employed with the Company (“Time-Based RSUs”). During the six months ended June 30, 2019, the Company granted Time-Based RSUs under the 2013 Stock Incentive Plan (the “2013 Plan”) that vest in four equal annual installments. The following is a summary of RSU activity for the 2013 Plan for the six months ended June 30, 2019:
The total stock-based compensation expense related to RSUs for the six months ended June 30, 2019 and 2018 was $819 and $78, respectively. As of June 30, 2019, there was $7,476 of unrecognized compensation costs related to unvested Time-Based RSUs, which are expected to be recognized over a weighted-average period of 3.6 years. Separately, during the year ended December 31, 2017, the Company also granted performance-based RSUs, which vest upon the achievement of certain performance goals subject to the employee’s continued employment (“Performance-Based RSUs”). During the six months ended June 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 of 2018. The remaining 98,800 Performance-Based RSUs were forfeited in July 2018 when the other performance goal was not achieved. Employee Stock Purchase Plan The Company has an Employee Stock Purchase Plan (“ESPP”) that permits eligible employees to enroll in -month six-month offering period, whichever is lower. Purchase dates under the ESPP occur on or about May 1 and November 1 of each year. In 2013, the Company’s stockholders approved the reservation of 242,424 shares of the Company’s 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’s common stock, 1 % of the number of outstanding shares on such date, or an amount determined by the board of directors.For the six months ended June 30, 2019 and 2018, the Company recorded stock-based compensation expense related to the ESPP of $432 and $177, respectively. As of June 30, 2019, 720,676 shares of the Company’s common stock remained available for issuance under the ESPP. As of June 30, 2019, there was $472 of total unrecognized stock-based compensation expense related to the ESPP. The expense is expected to be recognized over a period of four months . |
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Leases |
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| Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases | 8. Leases Operating Leases The Company is party to an operating lease of 98,502 square feet of office and research space in Newton, Massachusetts with a term through September 30, 2025 (the “Newton, MA Lease”). Pursuant to the Newton, MA Lease, the Company has provided a security deposit in the form of a cash-collateralized letter of credit in the amount of $550. The amount is classified within non-current restricted cash on the condensed consolidated balance sheets.Upon the adoption of ASU 2016-02, the Company recorded an operating lease right-of-use asset of $11,711 and corresponding lease liability of $16,023 related only to the Newton, MA Lease. As of December 31, 2018, there was a balance of $1,665 and $2,646 related to unamortized deferred rent and tenant incentive allowances for the Newton, MA Lease, both accounted for as liabilities onthe Company’s condensed consolidated balance sheet. These balances were deducted from the lease liability on the Newton, MA Lease in arriving at the right-of-use asset upon adoption of ASU 2016-02 on January 1, 2019. The Newton, MA Lease provides for increases in future minimum annual rental payments, as defined in the lease agreement. The Newton, MA Lease also includes real estate taxes and common area maintenance (“CAM”) charges in the annual rental payments. As these charges were included in minimum annual rental payments as part of the Company’s accounting for the Newton, MA Lease under ASC 840 through December 31, 2018, the Company has included such amounts in the calculation of the operating lease liability, consistent with ASC 842 and the Company’s accounting policy elections thereunder, as specified in Note 2, “Recent Accounting Pronouncements.” The operating lease cost for the Newton, MA Lease for the six months ended June 30, 2019 was $1,404, of which approximately $441 was charges for CAM. The Company is also party to operating leases in both Munich, Germany and Tel Aviv, Israel with lease periods through and , respectively. The remaining lease payments on such arrangements were $54 in aggregate, as of June 30, 2019, and therefore, the associated operating lease liabilities and operating lease right-of-use assets were not capitalized upon adoption of ASU 2016-02. The operating lease cost for these arrangements was $75 for the six months ended June 30, 2019.In addition, the Company is party to short-term leases having a term of twelve months or less at the commencement date. The Company recognizes short-term lease expense on a straight-line basis and does not record a related right-of use asset or lease liability for such leases. These costs were insignificant for the six months ended June 30, 2019.Lease Commitments As of June 30, 2019, future minimum lease payments under
non-cancellable operating lease agreements for which the Company has recognized operating lease right-of-use assets and liabilities are as follows:
As of June 30, 2019, the remaining lease term on the Newton, MA Lease was 6.2 years. The lease has a renewal option for an additional five years, although there is no economic penalty for failure to exercise the option. However, because the Company did not elect the use of hindsight in estimating the lease term for leases subject to transition to the new standard, and the renewal option was not previously considered in the Company’s assessment of the lease term for the Newton, MA Lease before adoption of ASC 842, the renewal option was not considered as part of the lease term in calculating the operating lease right-of-use assets and liabilities as of January 1, 2019.As a discount rate was not directly observable for the Company’s Newton, MA Lease, the discount rate used to calculate the net present value of future payments was the Company’s incremental borrowing rate calculated at transition based on the remaining lease term. Upon adoption and through June 30, 2019, the discount rate used to calculate the operating lease liability was 11.0%. The incremental borrowing rate is the rate of interest that the Company would expect to pay to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. In determining the incremental borrowing rate, the Company considered (i) its estimated public credit rating, (ii) observable debt yields of the Company, as well as other bonds in the market issued by other companies with similar credit ratings as the Company, and (iii) adjustments necessary for collateral, lease term, and inflation or foreign currency. |
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Equity |
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| Federal Home Loan Banks [Abstract] | |
| Equity | 9. Equity Underwritten Offerings On May 7, 2018, the Company completed a follow-on offering under its shelf registration statement on Form S-3 (File No. 333-222726) pursuant to which the Company issued an aggregate of 10,525,424 shares of common stock, which included the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $14.75 per share. The Company received aggregate net proceeds of approximately $145,720 from the offering after deducting the underwriting discounts and commissions and other offering expenses.Open Market Sale Agreement On August 17, 2018, the Company entered into an Open Market Sale Agreement (the “Open Market Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”), pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $75,000 (the “Open Market Shares”) from time to time through Jefferies (the “Open Market Offering”). Under the Open Market Sale Agreement, Jefferies may sell the Open Market Shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. The Company may sell the Open Market Shares in amounts and at times to be determined by the Company from time to time subject to the terms and conditions of the Open Market Sale Agreement, but it has no obligation to sell any of the Open Market Shares in the Open Market Offering. The Company or Jefferies may suspend or terminate the offering of Open Market Shares upon notice to the other party and subject to other conditions. The Company has agreed to pay Jefferies commissions for its services in acting as agent in the sale of the Open Market Shares in the amount of up to 3.0% of gross proceeds from the sale of the Open Market Shares pursuant to the Open Market Sale Agreement. The Company has also agreed to provide Jefferies with customary indemnification and contribution rights. |
Convertible Senior Notes |
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| 3% Convertible Senior Notes Due 2025 [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Convertible Senior Notes | 10. Convertible Senior Notes 3.00% Convertible Senior Notes due 2025 On October 16, 2018, the Company completed an offering of $150,000 aggregate principal amount of the Company’s 3.00% convertible senior notes due 2025 (the “Notes”). In addition, on October 26, 2018, the Company issued an additional $22,500 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 were sold in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act. In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability component (“Liability Component”) and the embedded conversion option (“Equity Component”) of the Notes by allocating the proceeds between the Liability Component and the Equity Component, due to the Company’s ability to settle the Notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at its option. In connection with the issuance of the Notes, the Company incurred approximately $5,615 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs between the Liability Component and the Equity Component based on the allocation of the proceeds. Of the total debt issuance costs, $2,209 was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $3,407 was allocated to the Liability Component and recorded as a reduction of the Notes in the Company’s consolidated balance sheets. The portion allocated to the Liability Component is amortized to interest expense using the effective interest method over seven years.The Notes are senior unsecured obligations of the Company 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. Upon conversion, the Notes will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. Holders of the Notes may convert all or any portion of their Notes, in multiples of $1 principal amount, at their option at any time prior to the close of business on the business day immediately preceding June 15, 2025 only under the following circumstances:
As of June 30, 2019, none of the above circumstances had occurred and as such, the Notes could not have been converted. The Company may not redeem the Notes prior to October 15, 2022. On or after October 15, 2022, the Company may redeem for cash all or part of the Notes at its option 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 redeemed, plus accrued and unpaid interest, if any. In addition, calling any convertible note for redemption will constitute a make-whole fundamental change with respect to that convertible note, in which case the conversion rate applicable to the conversion of that convertible note, if it is converted in connection with the redemption, will be increased in certain circumstances.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 sends any notice of redemption. The redemption price will be 100% of the principal amount of the Notes to be The initial carrying amount of the Liability Component of $101,243 was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company’s non-convertible borrowing rate for similar debt. The Equity Component of the Notes of $67,850 was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Notes of $172,500 and the fair value of the liability of the Notes of approximately $104,650 on their respective dates of issuance. The excess of the principal amount of the Liability Component over its carrying amount is amortized to interest expense using the effective interest method over seven years . The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification.The outstanding balances of the Notes as of June 30, 2019 consisted of the following (in thousands):
The Company determined the expected life of the Notes was equal to its seven-year term. The effective interest rate on the Liability Component of the Notes was 11.85%. As of June 30, 2019, the “if-converted value” did not exceed the remaining principal amount of the Notes. The fair value of the Notes was determined based on data points other than quoted prices that are observable, either directly or indirectly, and has been classified as Level 2 within the fair value hierarchy. The fair value of the Notes, which differs from their carrying value, is influenced by market interest rates, the Company’s stock price and stock price volatility. The estimated fair value of the Notes as of June 30, 2019 was approximately $105,918 .The following table sets forth total interest expense recognized related to the Notes during the six months ended June 30, 2019 (in thousands):
Future minimum payments on the Notes as of June 30, 2019 were as follows (in thousands):
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Summary of Significant Accounting Policies (Policies) |
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| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements of Karyopharm Therapeutics Inc., a Delaware corporation (the “Company”), have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and six months ended June 30, 2019 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2019. For further information, refer to the financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the Securities and Exchange Commission (“SEC”) on February 28, 2019.In July 2019, the U.S. Food and Drug Administration (“FDA”) approved XPOVIO TM At June 30, 2019, the Company had $217,159 in cash, cash equivalents and investments. The Company has had recurring losses and incurred a loss of $109,576 for the six months ended June 30, 2019. Net cash used in operations for the six months ended June 30, 2019 was $114,827. The Company expects that its cash, cash equivalents and investments at June 30, 2019 will be sufficient to fund current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of these financial statements , during which time the Company plans to continue to commercialize XPOVIO in the United States , which commenced in July 2019. |
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| Basis of Consolidation | Basis of Consolidation The condensed consolidated financial statements at June 30, 2019 include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The significant accounting policies used in preparation of these condensed consolidated financial statements on Form 10-Q for the six months ended June 30, 2019 are consistent with those discussed in Note 2 to the financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, except as it relates to the adoption of new accounting standards during the first six months of 2019 as discussed below. |
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| Recent Accounting Pronouncements | 2. Recent Accounting Pronouncements Recently Adopted Accounting Standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) 2016-02”). ASU 2016-02 supersedes the lease guidance under FASB ASC Topic 840, Leases Leases right-of-use assets, representing the right to use the underlying asset for the lease term for both finance and operating leases, and (ii) disclose qualitative and quantitative information about its leasing arrangements.In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases (“ASU 2018-10”) and ASU No. 2018-11, Leases (Topic 842) Targeted Improvements (“ASU 2018-11”). The amendments in ASU 2018-10 and ASU 2018-11 provide additional clarification and implementation guidance on certain aspects of ASU 2016-02 and have the same effective and transition requirements as ASU 2016-02, as detailed below. ASU 2018-11 provides entities the option to not provide comparative period financial statements and instead apply the transition requirements as of the effective date of ASU 2016-02.below within Note 3, “License and Asset Purchase Agreements,” were previously accounted for under ASC 606, not ASC 808, and the Company has no other arrangements within the scope of ASC 808. On August 17, 2018, the SEC issued an amendment to Rule 3-04 of Regulation S-X, which extended the annual disclosure requirement of reporting changes in stockholders’ equity to interim periods. Such disclosures are to be provided in a note to the financial statements or in a separate financial statement and requires both the year-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 date of the requirement. Under the guidance in C&DI 105.09, the Company implemented this updated disclosure requirement beginning with the Form 10-Q for the quarterly period ended March 31, 2019, specifically through inclusion of the comparative condensed consolidated statements of stockholders’ equity. Recently Issued Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2019. The Company is currently evaluating the effects the adoption of ASU 2016-13 will have on its consolidated financial statements and related disclosures.In August 2018, the FASB issued ASU No. 2018-13, F air Value Measurement—Disclosure Framework-Changes to the Disclosure Requirement for Fair Value Measurement 2018-13”). The amendments in ASU 2018-13 modify the disclosure requirements on fair value measurements in ASC 820, Fair Value Measurement, based on the concepts in the FASB Concepts Statement, including the consideration of costs and benefits. The amendments under ASU 2018-13 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company is currently evaluating the effects the adoption of ASU 2018-13 will have on its consolidated financial statements and related disclosures.In August 2018, the FASB issued ASU No. 2018-15, Intangible-Goodwill and Other Internal-Use Software (Subtopic 350-40) 2018-15”). 2018-15 updates guidance regarding accounting for implementation costs associated with a cloud computing arrangement that is a service contract. The amendments under ASU 2018-15 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption of ASU 2018-15 to have a material impact on its consolidated financial statements.ASU 2016-02, ASU 2018-10, and ASU 2018-11 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. Early adoption is permitted. The Company adopted the standard effective January 1, 2019 using the optional transition method under ASU 2018-11 and, therefore, prior period financial information has not been retrospectively adjusted. Pursuant to the guidance under ASU 2016-02, the Company elected the optional package of practical expedients to leases that commenced prior to the effective date, which allowed 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 elected, including: (i) a policy to not record right-of-use assets and leases on the balance sheet for short-term leases that qualify and (ii) a policy to not separate lease and non-lease components for certain classes of underlying assets on contracts entered into or modified after the effective date. The Company did not elect the use of hindsight in estimating the lease term for leases subject to transition to the new standard. As summarized in the table below, the standard had a material impact on the Company’s condensed consolidated balance sheet as of June 30, 2019, specifically through recognition of right-of-use assets of $11,711 and lease liabilities of $16,023 for the Company’s existing operating lease for office space in Newton, MA on the effective date. The difference between the operating lease right-of-use assets and operating lease liabilities is due to the change in classification of deferred rent and lease incentives, as recorded on the Company’s condensed consolidated balance sheets through December 31, 2018, from liabilities to reduction in the Company’s operating lease right-of-use assets. However, the standard did not have a material impact on the Company’s condensed consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2019, as expense for the Company’s existing operating leases continues to be recognized consistent with the recognition pattern before adoption of the new standard. Please refer to Note 8, “Leases” for further information.
The Company implemented internal controls to enable the preparation of financial information upon adoption. In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting 2018-07”). ASU 2018-07 largely aligns the accounting for share-based payment awards issued to employees and nonemployees by expanding the scope of Topic 718 to apply to nonemployee share-based transactions, as long as the transaction is not effectively a form of financing. The new guidance was adopted on January 1, 2019 and it did not have a material impact on the Company’s condensed consolidated financial statements.In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements 2018-09”). This amendment makes changes to a variety of topics to clarify, correct errors in, or make minor improvements to the Accounting Standards Codification. The amendments are effective for annual periods beginning after December 15, 2018 and were adopted effective January 1, 2019. The adoption of these amendments did not have a material impact on the Company’s condensed consolidated financial statements.In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606 2018-18”). The amendments in ASU 2018-18 clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606, Revenue from Contracts with Customers 2018-18 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The amendments in ASU 2018-18 should be applied retrospectively to the date of initial application of ASC 606. The Company adopted this guidance effective January 1, 2019 using the modified retrospective approach. The adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements, as each of the Company’s arrangements detailed |
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Recent Accounting Pronouncements (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Changes and Error Corrections [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Adjustments in Balance Sheet due to Adoption of ASC 842 |
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Fair Value of Financial Instruments (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Financial Assets That Have Been Measured at Fair Value | The following table presents information about the Company’s financial assets that have been measured at fair value at June 30, 2019 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands):
The following table presents information about the Company’s financial assets that have been measured at fair value at December 31, 2018 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands):
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Investments (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Investments, Classified as Available-for-Sale | The following table summarizes the Company’s investments in debt securities, classified as
available-for-sale, as of June 30, 2019 (in thousands):
The following table summarizes the Company’s investments in debt securities, classified as
available-for-sale as of December 31, 2018 (in thousands):
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Net Loss Per Share (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||
| Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Potentially Dilutive Securities Were Excluded From The Calculation of Diluted Net Loss Per Share Due to Their Anti-Dilutive Effect | The following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
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Stock-based Compensation (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Stock Option Activity for Employees and Nonemployees | A summary of the Company’s stock option activity and related information follows:
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| Summary of RSU Activity | During the six months ended June 30, 2019, the Company granted Time-Based RSUs under the 2013 Stock Incentive Plan (the “2013 Plan”) that vest in four equal annual installments. The following is a summary of RSU activity for the 2013 Plan for the six months ended June 30, 2019:
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Leases (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Minimum Future Rent Payments Under Lease Agreement | As of June 30, 2019, future minimum lease payments under
non-cancellable operating lease agreements for which the Company has recognized operating lease right-of-use assets and liabilities are as follows:
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Convertible Senior Notes (Tables) - 3% Convertible Senior Notes Due 2025 [Member] |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Outstanding Balances of Convertible Notes | The outstanding balances of the Notes as of June 30, 2019 consisted of the following (in thousands):
|
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| Schedule of Interest Expense Recognized Related to Convertible Notes | The following table sets forth total interest expense recognized related to the Notes during the six months ended June 30, 2019 (in thousands):
|
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| Summary of Future Minimum Payments on Convertible Notes | Future minimum payments on the Notes as of June 30, 2019 were as follows (in thousands):
|
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Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
| Regulatory Assets [Abstract] | ||||
| Cash, cash equivalents and short and long-term investments | $ 217,159 | $ 217,159 | ||
| Net loss | $ 43,415 | $ 33,655 | 109,576 | $ 72,114 |
| Net cash used in operations | $ 114,827 | $ 72,280 | ||
Recent Accounting Pronouncements - Additional Information (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Jan. 01, 2019 |
|||||
|---|---|---|---|---|---|---|---|
| New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
| Operating lease, right-of-use asset | $ 11,180 | $ 11,711 | [1] | ||||
| Lease liability | 15,577 | $ 1,175 | [2] | ||||
| Accounting Standards Update 2016-02 [Member] | |||||||
| New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
| Operating lease, right-of-use asset | 11,711 | ||||||
| Lease liability | $ 16,023 | ||||||
| |||||||
Recent Accounting Pronoucements - Schedule of Adjustments in Balance Sheet due to Adoption of ASC 842 (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Jan. 01, 2019 |
Dec. 31, 2018 |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Adjustments For Change In Accounting Principle [Line Items] | |||||||||||
| Operating lease and right-of-use assets | $ 11,180 | $ 11,711 | [1] | ||||||||
| Deferred rent | $ 390 | ||||||||||
| Deferred rent non-current | $ 3,922 | ||||||||||
| Operating lease liabilities | 15,577 | 1,175 | [2] | ||||||||
| Non-current operating lease liabilities | $ 14,055 | 14,848 | [2] | ||||||||
| Previously Reported [Member] | |||||||||||
| Adjustments For Change In Accounting Principle [Line Items] | |||||||||||
| Deferred rent | [3] | 390 | |||||||||
| Deferred rent non-current | [3] | 3,922 | |||||||||
| Restatement Adjustment [Member] | |||||||||||
| Adjustments For Change In Accounting Principle [Line Items] | |||||||||||
| Operating lease and right-of-use assets | [1] | 11,711 | |||||||||
| Deferred rent | [3] | (390) | |||||||||
| Deferred rent non-current | [3] | (3,922) | |||||||||
| Operating lease liabilities | [2] | 1,175 | |||||||||
| Non-current operating lease liabilities | [2] | $ 14,848 | |||||||||
| |||||||||||
License and Asset Purchase Agreements - Additional Information - Biogen Asset Purchase Agreement (Detail) - Biogen MA Inc [Member] - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Jan. 24, 2018 |
Jun. 30, 2019 |
|
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
| Revenues | $ 10,000 | |
| Asset Purchase Agreement [Member] | ||
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
| Upfront payment received | $ 10,000 | |
| Commercial milestone payments receivable | 65,000 | |
| Asset Purchase Agreement [Member] | Scenario, Plan [Member] | Maximum [Member] | Sales Milestone [Member] | ||
| Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
| Milestone payments receivable | $ 142,000 |
Investments - Additional Information (Detail) |
Jun. 30, 2019
USD ($)
Securities
|
Dec. 31, 2018
USD ($)
Securities
|
|---|---|---|
| Debt Securities, Available-for-sale [Line Items] | ||
| Number of debt securities with unrealized loss position for less than one year | Securities | 9 | 79 |
| Aggregate fair value of debt securities with unrealized loss position for less than one year | $ 19,713,000 | $ 180,627,000 |
| Unrealized losses , included in accumulated other comprehensive loss | 13,000 | 227,000 |
| Unrealized losses, other-than-temporary impairments | $ 0 | $ 0 |
| Corporate Debt Securities [Member] | ||
| Debt Securities, Available-for-sale [Line Items] | ||
| Number of corporate debt securities with continuous unrealized loss position for more than 12 months | Securities | 2 | |
| Aggregate fair value of corporate debt securities with continuous unrealized loss position for more than 12 months | $ 3,496,000 | |
| Unrealized losses , included in accumulated other comprehensive loss | $ 4,000 |
Net Loss Per Share - Schedule of Potentially Dilutive Securities Were Excluded From The Calculation of Diluted Net Loss Per Share Due to Their Anti-Dilutive Effect (Detail) - shares |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2019 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
|
| Outstanding Stock Options [Member] | ||||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
| Dilutive securities excluded from the calculation of diluted net loss per share due to anti-dilutive effect (in shares) | 10,410,757 | 8,996,219 | 10,410,757 | 8,996,219 |
| Unvested Restricted Stock Units [Member] | ||||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
| Dilutive securities excluded from the calculation of diluted net loss per share due to anti-dilutive effect (in shares) | 903,900 | 123,800 | 903,900 | 123,800 |
Net Loss Per Share - Additional Information (Detail) - 3% Convertible Senior Notes Due 2025 [Member] |
6 Months Ended | |
|---|---|---|
Oct. 16, 2018 |
Jun. 30, 2019 |
|
| Notes, interest rate | 3.00% | 11.85% |
| Notes, maturity date | Oct. 15, 2025 |
Stock-based Compensation - Summary of RSU Activity (Detail) - Unvested Restricted Stock Units [Member] |
6 Months Ended |
|---|---|
|
Jun. 30, 2019
$ / shares
shares
| |
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
| Number of Shares Underlying RSUs, Unvested beginning balance | shares | 25,000 |
| Number of Shares Underlying RSUs, Granted | shares | 1,024,750 |
| Number of Shares Underlying RSUs, Forfeited | shares | (140,850) |
| Number of Shares Underlying RSUs, Vested | shares | (5,000) |
| Number of Shares Underlying RSUs, Unvested ending balance | shares | 903,900 |
| Weighted-Average Grant Date Fair Value, Unvested beginning balance | $ / shares | $ 9.87 |
| Weighted-Average Grant Date Fair Value, Granted | $ / shares | 9.18 |
| Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 9.21 |
| Weighted-Average Grant Date Fair Value, Vested | $ / shares | 10.27 |
| Weighted-Average Grant Date Fair Value, Unvested ending balance | $ / shares | $ 9.19 |
Leases - Schedule of Minimum Future Rent Payments Under Lease Agreement (Detail) - USD ($) $ in Thousands |
Jun. 30, 2019 |
Jan. 01, 2019 |
[1] | ||
|---|---|---|---|---|---|
| Commitments and Contingencies Disclosure [Abstract] | |||||
| 2019 | $ 1,571 | ||||
| 2020 | 3,200 | ||||
| 2021 | 3,277 | ||||
| 2022 | 3,447 | ||||
| 2023 and thereafter | 10,453 | ||||
| Total minimum lease payments | 21,948 | ||||
| Less: present value adjustment | (6,371) | ||||
| Present value of minimum lease payments | $ 15,577 | $ 1,175 | |||
| |||||
Equity - Controlled Equity Offering Sales Agreement - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 6 Months Ended | |||
|---|---|---|---|---|---|
May 07, 2018 |
Jun. 30, 2018 |
Jun. 30, 2019 |
Jun. 30, 2018 |
Aug. 17, 2018 |
|
| Common Stock [Member] | |||||
| Equity Offering [Line Items] | |||||
| Number of shares of common stock sold in public offering | 10,525,424 | 10,525,424 | 10,525,424 | ||
| Public offering price of common shares | $ 14.75 | ||||
| Net proceeds after deducting underwriting discounts, commissions and offering expenses | $ 145,720 | ||||
| Open Market Sale Agreement [Member] | |||||
| Equity Offering [Line Items] | |||||
| Number of shares of common stock sold in public offering | 0 | ||||
| Maximum [Member] | Jefferies LLC [Member] | Open Market Sale Agreement [Member] | |||||
| Equity Offering [Line Items] | |||||
| Aggregate offering price | $ 75,000 | ||||
| Percentage of commission of gross proceeds from the sale of Shares | 3.00% | ||||
Convertible Senior Notes - Additional Information (Detail) |
6 Months Ended | |||
|---|---|---|---|---|
|
Oct. 15, 2022
d
|
Oct. 16, 2018
USD ($)
$ / shares
shares
|
Jun. 30, 2019
USD ($)
d
|
Oct. 26, 2018
USD ($)
|
|
| Subsequent Event [Line Items] | ||||
| Debt instrument convertible threshold consecutive trading days | d | 5 | |||
| Description of debt instrument convertible period | during the five business day period immediately after any five consecutive trading day | |||
| Principal amount of notes used in conversion rate | $ 1,000 | |||
| Debt instrument convertible threshold maximum percentage of product of last reported sale price of common stock | 98.00% | |||
| Equity component of convertible notes recognized as debt discount | $ 67,850,000 | |||
| Proceeds from issuance of convertible notes | 172,500,000 | |||
| Fair value of liability of convertible notes | 104,650,000 | |||
| Estimated fair value of convertible notes | $ 105,918,000 | |||
| Expected life of convertible notes | 7 years | |||
| Debt instrument, convertible, if-converted value in excess of principal | $ 0 | |||
| Convertible Note Offering [Member] | ||||
| Subsequent Event [Line Items] | ||||
| Notes converted in to common stock, amount | shares | 63.0731 | |||
| Notes converted in to common stock, shares | $ 1,000 | |||
| Notes, conversion price per share | $ / shares | $ 15.85 | |||
| 3% Convertible Senior Notes Due 2025 [Member] | ||||
| Subsequent Event [Line Items] | ||||
| Aggregate principal amount | $ 150,000,000 | $ 22,500,000 | ||
| Debt issuance costs | 5,615,000 | |||
| Debt issuance costs allocated to equity component and recorded as a reduction to additional paid-in capital | 2,209,000 | |||
| Debt issuance costs allocated to liability component and recorded as a reduction of convertible notes | $ 3,407,000 | |||
| Debt discount and issuance costs amortized to interest expense, amortization period | 7 years | |||
| Notes, interest rate | 3.00% | 11.85% | ||
| Notes, maturity date | Oct. 15, 2025 | |||
| Principal amount of notes used in conversion rate | $ 1 | |||
| Debt instrument, convertible latest date | Jun. 15, 2025 | |||
| Notes conversion price, percentage | 130.00% | |||
| Notes instrument, trading days | d | 20 | |||
| Debt instrument convertible threshold consecutive trading days | d | 30 | |||
| Initial amount of liability component | $ 101,243,000 | |||
| Equity component of convertible notes recognized as debt discount | $ 70,059,000 | |||
| 3% Convertible Senior Notes Due 2025 [Member] | Scenario, Forecast [Member] | ||||
| Subsequent Event [Line Items] | ||||
| Notes conversion price, percentage | 130.00% | |||
| Notes instrument, trading days | d | 20 | |||
| Debt instrument convertible threshold consecutive trading days | d | 30 | |||
| Notes, repurchase price | 100.00% |
Convertible Senior Notes - Summary of Outstanding Balances of Convertible Notes (Detail) $ in Thousands |
Jun. 30, 2019
USD ($)
|
|---|---|
| Liability component: | |
| Equity component | $ 67,850 |
| 3% Convertible Senior Notes Due 2025 [Member] | |
| Liability component: | |
| Principal | 172,500 |
| Less: debt discount and issuance costs, net | (66,343) |
| Net carrying amount | 106,157 |
| Equity component | $ 70,059 |
Convertible Senior Notes - Schedule of Interest Expense Recognized Related to Convertible Notes (Detail) - 3% Convertible Senior Notes Due 2025 [Member] $ in Thousands |
6 Months Ended |
|---|---|
|
Jun. 30, 2019
USD ($)
| |
| Debt Instrument [Line Items] | |
| Contractual interest expense | $ 2,594 |
| Amortization of debt discount | 3,326 |
| Amortization of debt issuance costs | 167 |
| Total interest expense | $ 6,087 |
Convertible Senior Notes - Summary of Future Minimum Payments on Convertible Notes (Detail) - 3% Convertible Senior Notes Due 2025 [Member] $ in Thousands |
Jun. 30, 2019
USD ($)
|
|---|---|
| Debt Instrument [Line Items] | |
| 2019 | $ 5,175 |
| 2020 | 5,175 |
| 2021 | 5,175 |
| 2022 | 5,175 |
| 2023 and thereafter | 188,025 |
| Total minimum payments | 208,725 |
| Less: interest | (36,225) |
| Less: unamortized discount | (66,343) |
| Less: current portion | 0 |
| Long Term Debt | $ 106,157 |