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 No.) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
The |
☒ | Accelerated filer | ☐ | ||||
Non-accelerated filer |
☐ | Smaller reporting company | ||||
Emerging growth company |
Page |
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3 | ||||||
Item 1. |
3 | |||||
3 | ||||||
4 | ||||||
5 | ||||||
7 | ||||||
8 | ||||||
Item 2. |
18 | |||||
Item 3. |
27 | |||||
Item 4. |
27 | |||||
28 | ||||||
Item 1. |
28 | |||||
Item 1A. |
28 | |||||
Item 2. |
64 | |||||
Item 3. |
64 | |||||
Item 4. |
64 | |||||
Item 5. |
64 | |||||
Item 6. |
65 | |||||
67 |
Item 1. |
Financial Statements |
September 30, 2020 |
December 31, 2019 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Short-term marketable securities |
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Accounts receivable, net |
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Long-term marketable securities |
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Operating lease right-of-use |
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Restricted cash |
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Other assets, noncurrent |
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Total assets |
$ | $ | ||||||
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
$ | $ | ||||||
Accrued liabilities |
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Accrued compensation |
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Other liabilities, current |
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Total current liabilities |
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Long-term debt |
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Operating lease liabilities, noncurrent |
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Other liabilities, noncurrent |
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Total liabilities |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive income |
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Accumulated deficit |
( |
) | ( |
) | ||||
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2020 |
2019 |
2020 |
2019 |
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Product sales, net |
$ | $ | — | $ | $ | — | ||||||||||
Costs and operating expenses: |
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Cost of sales |
— | — | ||||||||||||||
Research and development |
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Selling, general and administrative |
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Total costs and operating expenses |
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Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other income (expense): |
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Interest income |
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Interest expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other expenses, net |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
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Total other income (expense), net |
( |
) | ( |
) | ||||||||||||
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Net loss |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other comprehensive loss: |
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Net unrealized gain (loss) on marketable securities, net of tax |
( |
) | ( |
) | ( |
) | ||||||||||
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Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Basic and diluted net loss per common share |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Weighted-average number of shares used in computing basic and diluted net loss per common share |
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Common Stock |
Accumulated |
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Shares |
Amount |
Additional Paid- In Capital |
Other Comprehensive Income |
Accumulated Deficit |
Total Stockholders’ Equity |
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Balance at December 31, 2019 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
Issuance of common stock upon exercise of stock options |
— | — | — | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes |
— | ( |
) | — | — | ( |
) | |||||||||||||||||
Issuance of common stock pursuant to ESPP purchases |
— | — | — | |||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | ||||||||||||||||||||
Net unrealized gain on marketable securities |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
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Balance at March 31, 2020 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
Issuance of common stock upon exercise of stock options |
— | — | — | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes |
— | ( |
) | — | — | ( |
) | |||||||||||||||||
Stock-based compensation expense |
— | — | — | — | ||||||||||||||||||||
Net unrealized gain on marketable securities |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
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Balance at June 30, 2020 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
Issuance of common stock upon exercise of stock options |
— | — | — | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes |
— | ( |
) | — | — | ( |
) | |||||||||||||||||
Issuance of common stock pursuant to ESPP purchases |
— | — | — | |||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | ||||||||||||||||||||
Net unrealized loss on marketable securities |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
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Balance at September 30, 2020 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
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Common Stock |
Accumulated |
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Shares |
Amount |
Additional Paid- In Capital |
Other Comprehensive Income (Loss) |
Accumulated Deficit |
Total Stockholders’ Equity |
|||||||||||||||||||
Balance at December 31, 2018 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs |
— | — | — | |||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
— | — | — | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes |
— | ( |
) | — | — | ( |
) | |||||||||||||||||
Issuance of common stock pursuant to ESPP purchases |
— | — | — | |||||||||||||||||||||
Vesting of restricted stock purchases |
— | — | — | |||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | ||||||||||||||||||||
Net unrealized gain on marketable securities |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
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Balance at March 31, 2019 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs |
— | — | ||||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
— | — | ||||||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes |
— | ( |
) | — | — | ( |
) | |||||||||||||||||
Vesting of restricted stock purchases |
— | — | — | |||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | ||||||||||||||||||||
Net unrealized gain on marketable securities |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
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Balance at June 30, 2019 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs |
— | — | — | |||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
— | — | — | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes |
— | ( |
) | — | — | ( |
) | |||||||||||||||||
Issuance of common stock pursuant to ESPP purchases |
— | — | — | |||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | ||||||||||||||||||||
Net unrealized loss on marketable securities |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
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Balance at September 30, 2019 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
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Nine Months Ended September 30, |
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2020 |
2019 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
||||||||
Amortization (accretion) of premium (discount) on marketable securities |
( |
) | ||||||
Non-cash interest expense |
— | |||||||
Amortization of operating lease right-of-use |
||||||||
Stock-based compensation |
||||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivables |
( |
) | — | |||||
Inventories |
( |
) | — | |||||
Prepaid expenses and other assets |
( |
) | ( |
) | ||||
Accounts payable |
( |
) | ||||||
Accrued liabilities |
||||||||
Accrued compensation |
||||||||
Other liabilities, current |
( |
) | ( |
) | ||||
Operating lease liabilities |
( |
) | ||||||
— |
||||||||
( |
) | ( |
) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||||
Purchase of property and equipment |
( |
) | ( |
) | ||||
Purchase of marketable securities |
( |
) | ( |
) | ||||
Maturities of marketable securities |
||||||||
( |
) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||
Proceeds from issuance of common stock in public offering, net of issuance costs |
— | |||||||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options |
||||||||
Payments of debt issuance costs |
( |
) | — | |||||
Tax paid related to net share settlement of equity awards |
( |
) | ( |
) | ||||
Net increase (decrease) 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 |
$ | $ | ||||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: |
||||||||
Cash paid for interest |
$ | $ | — | |||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: |
||||||||
Leasehold improvements paid for by landlord |
$ | $ | ||||||
Accrued purchase of property and equipment |
$ | $ | ||||||
Accrued issuance costs |
$ | ( |
) | $ | — | |||
Operating lease liabilities arising from obtaining right-of-use |
$ | $ | ||||||
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH TO THE CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
$ | $ | |||||||
$ | $ | |||||||
September 30, 2020 |
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Total |
Level 1 |
Level 2 |
Level 3 |
|||||||||||||
Financial Assets: |
||||||||||||||||
Money market funds |
$ | $ | $ | — | $ | — | ||||||||||
Corporate debt securities |
— | — | ||||||||||||||
U.S. government agency securities |
— | — | ||||||||||||||
Certificates of deposits |
— | — | ||||||||||||||
U.S. government securities |
— | — | ||||||||||||||
|
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|
|
|
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|
|
|||||||||
Total financial assets |
$ | $ | $ | $ | — | |||||||||||
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|
December 31, 2019 |
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Total |
Level 1 |
Level 2 |
Level 3 |
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Financial Assets: |
||||||||||||||||
Money market funds |
$ | $ | $ | — | $ | — | ||||||||||
Corporate debt securities |
— | — | ||||||||||||||
U.S. government agency securities |
— | — | ||||||||||||||
Certificates of deposits |
— | — | ||||||||||||||
U.S. government securities |
— | — | ||||||||||||||
|
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|
|
|||||||||
Total financial assets |
$ | $ | $ | $ | — | |||||||||||
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|
September 30, 2020 |
December 31, 2019 |
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Amortized Cost |
Unrealized Gains |
Unrealized (Losses) |
Estimated Fair Value |
Amortized Cost |
Unrealized Gains |
Unrealized (Losses) |
Estimated Fair Value |
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Financial Assets: |
||||||||||||||||||||||||||||||||
Money market funds |
$ | $ | — | $ | — | $ | $ | $ | — | $ | — | $ | ||||||||||||||||||||
Corporate debt securities |
— | ( |
) | |||||||||||||||||||||||||||||
U.S. government agency securities |
— | ( |
) | |||||||||||||||||||||||||||||
Certificates of deposits |
— | |||||||||||||||||||||||||||||||
U.S. government securities |
— | |||||||||||||||||||||||||||||||
|
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Total |
$ | $ | $ | — | $ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||
|
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September 30, 2020 |
December 31, 2019 |
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Cash and cash equivalents |
$ | $ | ||||||
Short-term marketable securities |
||||||||
Long-term marketable securities |
||||||||
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|
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Total |
$ | $ | ||||||
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|
September 30, 2020 |
December 31, 2019 |
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Raw materials |
$ | $ | ||||||
Work-in-process |
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Finished goods |
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|
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Total inventories |
$ | $ | ||||||
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|
September 30, 2020 |
December 31, 2019 |
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Laboratory equipment |
$ | $ | ||||||
Computer equipment |
||||||||
Leasehold improvements |
||||||||
Construction-in-progress |
||||||||
Total property and equipment |
||||||||
Less: accumulated depreciation and amortization |
( |
) | ( |
) | ||||
Property and equipment, net |
$ | $ | ||||||
September 30, 2020 |
December 31, 2019 |
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Accrued research and development costs |
$ | $ | ||||||
Accrued manufacturing costs |
||||||||
Accrued professional and consulting services |
||||||||
Accrued sales deductions |
||||||||
Other |
||||||||
Total accrued liabilities |
$ | $ | ||||||
September 30, 2020 |
December 31, 2019 |
|||||||
Operating lease liabilities, current |
$ | $ | ||||||
Other payable |
||||||||
Total other liabilities, current |
$ | $ | ||||||
Year ending December 31, |
Amount |
|||
2020 (three months) |
$ | |||
2021 |
||||
2022 |
||||
2023 |
||||
2024 |
||||
2025 |
||||
Total minimum payments |
||||
Less amount representing interest |
( |
) | ||
Less amount representing Paydown Fee |
( |
) | ||
Long-term debt, gross |
||||
Discount on notes payable |
( |
) | ||
Accretion of Paydown Fee |
||||
Long-term debt |
$ | |||
Nine Months Ended September 30, |
||||||||
2020 |
2019 |
|||||||
ROU assets obtained in exchange for new operating lease |
$ | $ | ||||||
Cash paid for amounts included in the measurement of lease liabilities |
||||||||
Weighted-average remaining lease term of operating leases (in years) |
||||||||
Weighted-average discount rate of operating leases |
% | % |
Year ending December 31, |
Amount |
|||
2020 (three months) |
$ | |||
2021 |
||||
2022 |
||||
2023 |
||||
2024 |
||||
2025 |
||||
Thereafter |
||||
Total lease payments |
||||
Less: Imputed interest |
( |
) | ||
Present value of operating lease liabilities |
$ | |||
Number of Options |
Weighted- Average Exercise Price |
|||||||
Outstanding — December 31, 2019 |
$ | |||||||
Options granted |
||||||||
Options exercised |
( |
) | ||||||
Options canceled |
( |
) | ||||||
Outstanding — September 30, 2020 |
$ | |||||||
Three Months Ended September 30, |
Nine Months Ended September 30, | |||||||
2020 |
2019 |
2020 |
2019 | |||||
Expected term (in years) |
||||||||
Volatility |
||||||||
Risk-free interest rate |
||||||||
Dividend yield |
Number of RSUs |
Weighted- Average Grant Date Fair Value |
|||||||
Non-vested units — December 31, 2019 |
$ | |||||||
RSUs granted |
||||||||
RSUs vested |
( |
) | ||||||
RSUs forfeited |
( |
) | ||||||
Non-vested units — September 30, 2020 |
$ | |||||||
Stock Price Targets |
Number of Units Allotted | |
$ |
||
$ |
||
$ |
Number of Units |
Weighted- Average Grant Date Fair Value |
Weighted- Average Remaining Vesting Period (years) |
Aggregate Intrinsic Value |
|||||||||||||
Non-vested market-condition awards — December 31, 2019 |
$ | — | — | |||||||||||||
Granted |
||||||||||||||||
Vested |
— | — | ||||||||||||||
Forfeited |
( |
) | ||||||||||||||
Non-vested market-condition awards — September 30, 2020 |
$ | $ | ||||||||||||||
Valuation date stock price |
$ | |||
Volatility |
% | |||
Risk-free interest rate |
% | |||
Dividend yield |
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
Selling, general and administrative |
||||||||||||||||
Total stock-based compensation expense |
$ | $ | $ | $ | ||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||
Options to purchase common stock |
||||||||||||||||
Restricted stock units |
||||||||||||||||
Total |
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Item 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Three Months Ended September 30, |
$ Change |
% Change |
||||||||||||||
2020 |
2019 |
|||||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Product sales, net |
$ | 36,889 | $ | — | $ | 36,889 | * | |||||||||
Costs and operating expenses: |
||||||||||||||||
Cost of sales |
513 | — | 513 | * | ||||||||||||
Research and development |
40,196 | 39,088 | 1,108 | 3 | % | |||||||||||
Selling, general and administrative |
54,491 | 29,654 | 24,837 | 84 | % | |||||||||||
|
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|
|
|
|||||||||||
Total costs and operating expenses |
95,200 | 68,742 | 26,458 | 38 | % | |||||||||||
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