Item 1. |
FINANCIAL STATEMENTS |
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3 |
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4 |
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5 |
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6 |
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7 |
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Item 2. |
23 |
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Item 3. |
35 |
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Item 4. |
36 |
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PART II. OTHER INFORMATION |
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Item 1. |
36 |
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Item 1A. |
36 |
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Item 2. |
37 |
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Item 3. |
37 |
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Item 4. |
37 |
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Item 5. |
37 |
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Item 6. |
37 |
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38 |
June 30, 2020 |
December 31, 2019 |
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(unaudited) | ||||||||
ASSETS |
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Current Assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Short-term investments |
— | |||||||
Accounts receivable, net |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Operating lease right-of-use |
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Property and equipment, net |
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Deposits |
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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 expenses and other liabilities |
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Total current liabilities |
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Operating lease liability, net of current portion |
— | |||||||
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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, $ |
— | |||||||
Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
( |
) | ( |
) | ||||
Accumulated other comprehensive income (loss) |
( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
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2020 |
2019 |
2020 |
2019 |
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$ | $ | $ | $ | ||||||||||||
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Operating costs and expenses: |
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s |
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Research and development |
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Selling, general and administrative |
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Total operating costs and expenses |
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Operating income (loss) |
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Other income, net |
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Net income (loss) before income taxes |
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Provision for income taxes |
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Net income (loss) |
$ | $ | $ | $ | ||||||||||||
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Net income (loss) per share: |
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Basic |
$ | $ | $ | $ | ||||||||||||
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Diluted |
$ | $ | $ | $ | ||||||||||||
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Weighted average shares outstanding: |
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Basic |
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Diluted |
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Net income (loss) |
$ | $ | $ | $ | ||||||||||||
Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale |
( |
) | ( |
) | ||||||||||||
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Comprehensive income (loss) |
$ | $ | $ | $ | ||||||||||||
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Preferred |
Common Stock |
Additional Paid-in |
Accumulated |
Accumulated Other Comprehensive |
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Stock |
Shares |
Amount |
Capital |
Deficit |
Gain (Loss) |
Total |
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Balance at December 31, 2019 |
$ | — | $ | $ | $ | ( |
) | $ | $ | |||||||||||||||||||
Issuance of stock options for services |
— | — | — | — | — | |||||||||||||||||||||||
Exercise of stock options for common stock |
— | — | — | |||||||||||||||||||||||||
Amortization of restricted stock for services |
— | — | — | — | — | |||||||||||||||||||||||
Other comprehensive gain (loss) |
— | — | — | — | — | |||||||||||||||||||||||
Net income (loss) |
— | — | — | — | — | |||||||||||||||||||||||
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Balance at March 31, 2020 |
— | ( |
) | |||||||||||||||||||||||||
Issuance of stock options for services |
— | — | — | — | — | |||||||||||||||||||||||
Exercise of stock options for common stock |
— | — | — | |||||||||||||||||||||||||
Amortization of restricted stock for services |
— | — | — | — | — | |||||||||||||||||||||||
Other comprehensive gain (loss) |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Net income (loss) |
— | — | — | — | — | |||||||||||||||||||||||
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Balance at June 30, 2020 |
$ | — | $ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||||
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Preferred |
Common Stock |
Additional Paid-in |
Accumulated |
Accumulated Other Comprehensive |
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Stock |
Shares |
Amount |
Capital |
Deficit |
Gain (Loss) |
Total |
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Balance at December 31, 2018 |
$ |
— | $ |
$ |
$ |
( |
) | $ |
( |
) | $ |
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Issuance of stock options for services |
— | — | — | — | — | |||||||||||||||||||||||
Exercise of stock options for common stock |
— | — | — | |||||||||||||||||||||||||
Other comprehensive gain (loss) |
— | — | — | — | — | |||||||||||||||||||||||
Net income (loss) |
— | — | — | — | ( |
) | — | ( |
) | |||||||||||||||||||
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Balance at March 31, 2019 |
— | ( |
) | ( |
) | |||||||||||||||||||||||
Issuance of stock options for services |
— | — | — | — | — | |||||||||||||||||||||||
Exercise of stock options for common stock |
— | — | — | |||||||||||||||||||||||||
Other comprehensive gain (loss) |
— | — | — | — | — | |||||||||||||||||||||||
Net income (loss) |
— | — | — | — | — | |||||||||||||||||||||||
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Balance at June 30, 2019 |
$ | — | $ | $ | $ | ( |
) | $ | $ | |||||||||||||||||||
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For the Six Months Ended June 30, |
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2020 |
2019 |
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Operating Activities: |
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Net income (loss) |
$ | $ | ||||||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: |
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Depreciation |
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Amortization of right-of-use |
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Stock-based compensation |
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Change in accrued interest and accretion of discount on investments |
( |
) | ( |
) | ||||
(Increase) decrease in: |
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Accounts receivable, net |
( |
) | ||||||
Inventory |
( |
) | ||||||
Prepaid expenses and other current assets and deposits |
( |
) | ||||||
Increase (decrease) in: |
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Accounts payable |
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Accrued expenses and other liabilities |
( |
) | ||||||
Operating lease liability |
( |
) | ( |
) | ||||
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Net cash provided by (used in) operating activities |
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Investing Activities: |
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Purchases of property and equipment |
— | ( |
) | |||||
Purchases of investments |
— | ( |
) | |||||
Proceeds from maturities and sales of investments |
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Net cash provided by (used in) investing activities |
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Financing Activities: |
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Proceeds from exercise of stock options |
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Net cash provided by (used in) financing activities |
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Net increase (decrease) in cash and cash equivalents |
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Cash and cash equivalents—beginning of period |
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Cash and cash equivalents—end of period |
$ | $ | ||||||
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Supplemental disclosures of cash flow information: |
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Cash paid for income taxes |
$ | $ | — | |||||
Non-cash investing and financing activities: |
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Unrealized gain (loss) on available-for-sale |
$ | ( |
) | $ |
1. |
Organization and Description of Business. |
2. |
Basis of Presentation and Significant Accounting Policies. |
a. |
INTERIM FINANCIAL STATEMENTS. 10-Q was derived from the audited financial statements and does not include all disclosures required by U.S. GAAP. |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
b. |
PRINCIPLES OF CONSOLIDATION |
c. |
USE OF ESTIMATES. |
d. |
CASH AND CASH EQUIVALENTS. |
e. |
INVESTMENTS |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
f. |
ACCOUNTS RECEIVABLE, NET. |
g. |
INVENTORY. first-in-first-out - in- process and finished goods. Costs to be capitalized as inventories primarily include third party manufacturing costs and other overhead costs. The Company began capitalizing inventories post FDA approval of Firdapse® on November 28, 2018 as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to the FDA approval of Firdapse® were recorded as research and development expenses in prior years’ consolidated statements of operations and comprehensive income (loss). If information becomes available that suggests that inventories may not be realizable, the Company may be required to expense a portion or all of the previously capitalized inventories. As of June 30, 2020 and December 31, 2019, inventory consisted mainly of work-in-process |
h. |
PREPAID EXPENSES AND OTHER CURRENT ASSETS. pre-clinical studies, clinical trials and studies, regulatory affairs and consulting. Prepaid manufacturing consists of advances for the Company’s drug manufacturing activities. Such advances are recorded as expense as the related goods are received or the related services are performed. |
i. |
FAIR VALUE OF FINANCIAL INSTRUMENTS. |
j. |
FAIR VALUE MEASUREMENTS. |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
Fair Value Measurements at Reporting Date Using |
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Balances as of June 30, 2020 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
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Cash and cash equivalents: |
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Money market funds |
$ | $ | $ | — | $ | — | ||||||||||
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U.S. Treasuries |
$ | $ | — | $ | $ | — | ||||||||||
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Balances as of December 31, 2019 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
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Cash and cash equivalents: |
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Money market funds |
$ | $ | $ | — | $ | — | ||||||||||
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U.S. Treasuries |
$ | $ | — | $ | $ | — | ||||||||||
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Short-term investments: |
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U.S. Treasuries |
$ | $ | — | $ | $ | — | ||||||||||
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k. |
OPERATING LEASES. right-of-use non-lease components, which are generally accounted for separately. |
l. |
REVENUE RECOGNITION. ® in November 2018. Subsequent to receiving FDA approval, the Company entered into an arrangement with one distributor (the “Customer”), who is the exclusive distributor of Firdapse® in the United States. The Customer subsequently resells Firdapse® to a small group of exclusive specialty pharmacies (“SPs”) whose dispensing activities for patients with specific payors may result in government-mandated or privately negotiated rebate obligations for the Company with respect to the purchase of Firdapse® . |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
m. |
RESEARCH AND DEVELOPMENT. |
n. |
STOCK-BASED COMPENSATION. |
2. |
Basis of Presentation and Significant Accounting Policies ( continued ). |
o. |
CONCENTRATION OF RISK. Company to concentration of credit risk are cash equivalents (i.e., money market funds), investments and accounts receivable, net. The Company places its cash and cash equivalents with high-credit quality financial institutions. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in these accounts. |
p. |
ROYALTIES. |
q. |
INCOME TAXES. |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
r. |
COMPREHENSIVE INCOME (LOSS). available-for-sale |
s. |
NET INCOME (LOSS) PER COMMON SHARE. |
For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
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2020 |
2019 |
2020 |
2019 |
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Basic weighted average common shares outstanding |
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Effect of dilutive securities |
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Dilutive weighted average common shares outstanding |
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t. |
RECLASSIFICATIONS. |
u. |
RECENTLY ISSUED ACCOUNTING STANDARDS. 2018-18, Collaborative Arrangements (Topic 808), which amends ASC 808 to clarify when transactions between participants in a collaborative arrangement under ASC 808 are within the scope of the FASB’s new revenue standard, ASU 2014-09 (codified in ASC 606). The amendments require the application of ASC 606 existing guidance to determine the units of account that are distinct in a collaborative arrangement for purposes of identifying transactions with customers. If a unit of account within the collaborative arrangement is distinct and is with a customer, an entity shall apply the guidance in Topic 606 to that unit of account. In a transaction between collaborative participants, an entity is precluded by ASU 2018-18 from presenting a transaction together with “revenue from contracts with customers” unless the unit of account is within the scope of ASC 606 and the entity applies the guidance in ASC 606 to such unit of account. The Company adopted the new standard on January 1, 2020. The Company has a collaboration agreement with Endo Ventures Limited (Endo). See Note 7 (Collaborative Arrangement). However, these amendments did not have an impact on the Company’s consolidated financial statements, as Endo does not meet the definition of a customer. |
2. |
Basis of Presentation and Significant Accounting Policies (continued). |
3. |
Investments. |
Estimated Fair Value |
Gross Unrealized Gains |
Gross Unrealized Losses |
Amortized Cost |
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At June 30, 2020: |
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U.S. Treasuries – Cash equivalents |
$ | $ | — | $ | ( |
) | $ | |||||||||
At December 31, 2019: |
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U.S. Treasuries – Cash equivalents |
$ | $ | $ | — | $ | |||||||||||
U.S. Treasuries – ST |
— | |||||||||||||||
Total |
$ | $ | $ | — | $ | |||||||||||
June 30, 2020 |
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Due in one year or less |
$ | |||
4. |
Prepaid Expenses and Other Current Assets. |
June 30, 2020 |
December 31, 2019 |
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Prepaid manufacturing costs |
$ | $ | ||||||
Prepaid insurance |
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Prepaid subscription fees |
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Prepaid research fees |
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Prepaid commercialization expenses |
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Other |
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Total prepaid expenses and other current assets |
$ | $ | ||||||
5. |
Operating Leases. |
For the Three Months Ended June 30, 2020 |
For the Six Months Ended June 30, 2020 |
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Operating lease cost |
$ | $ |
June 30, 2020 |
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Cash paid for amounts included in the measurement of lease liabilities: |
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Operating cash flows |
$ | |||
Right-of-use |
||||
Operating leases |
$ |
June 30, 2020 |
||||
Operating lease right-of-use |
$ | |||
Other current liabilities |
$ | |||
Operating lease liabilities, net of current portion |
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Total operating lease liabilities |
$ | |||
Weighted average remaining lease term |
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Weighted average discount rate |
2020 (remaining six months) |
$ | |||
2021 |
||||
2022 |
||||
Total lease payments |
||||
Less imputed interest |
( |
) | ||
Total |
$ | |||
6. |
Accrued Expenses and Other Liabilities. |
June 30, 2020 |
December 31, 2019 |
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Accrued preclinical and clinical trial expenses |
$ | $ | ||||||
Accrued professional fees |
||||||||
Accrued compensation and benefits |
||||||||
Accrued license fees |
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Accrued purchases |
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Accrued contributions |
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Operating lease liability |
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Accrued variable consideration |
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Accrued income tax |
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Other |
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Current accrued expenses and other liabilities |
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Lease liability—non-current |
— | |||||||
Non-current accrued expenses and other liabilities |
— | |||||||
Total accrued expenses and other liabilities |
$ | $ | ||||||
7. |
Collaborative Arrangement. |
8. |
Commitments and Contingencies. |
8. |
Commitments and Contingencies (continued). |
9. |
Agreements. |
a. |
LICENSE AGREEMENT WITH BIOMARIN (FIRDAPSE ® ) ® . Under the license agreement, the Company pays: (i) royalties to the licensor for ® equal to ® equal to |
b. |
AGREEMENTS FOR DRUG MANUFACTURING, DEVELOPMENT, PRECLINICAL AND CLINICAL STUDIES. |
10. |
Income Taxes. |
11. |
Stockholders’ Equity. |
12. |
Stock Compensation. |
Three months ended June 30, |
Six months ended June 30, |
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2020 |
2019 |
2020 |
2019 |
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Research and development |
$ | $ | $ | $ | ||||||||||||
Selling, general and administrative |
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Total stock-based compensation |
$ | $ | |
$ | $ | |||||||||||
13. |
Subsequent Events. |
• | Overview. |
• | Basis of Presentation. the |
• | Critical Accounting Policies and Estimates. |
• | Results of Operations. six-month periods ended June 30, 2020 as compared to the same periods |
• | Liquidity and Capital Resources. off-balance sheet arrangements and our outstanding commitments, if any. |
• | Caution Concerning Forward-Looking Statements. |
Three months ended June 30, |
Change |
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2020 |
2019 |
$ |
% |
|||||||||||||
Research and development expenses |
$ | 3,928,423 | $ | 4,356,152 | (427,729 | ) | (9.8 | ) | ||||||||
Employee stock-based compensation |
421,220 | 273,212 | 148,008 | 54.2 | ||||||||||||
|
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|
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|
|
|
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Total research and development expenses |
$ | 4,349,643 | $ | 4,629,364 | (279,721 | ) | (6.0 | ) | ||||||||
|
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|
|
Six months ended June 30, |
Change |
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2020 |
2019 |
$ |
% |
|||||||||||||
Research and development expenses |
$ | 7,733,181 | $ | 7,376,390 | 356,791 | 4.8 | ||||||||||
Employee stock-based compensation |
839,273 | 560,933 | 278,340 | 49.6 | ||||||||||||
|
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|
|
|
|
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|
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Total research and development expenses |
$ | 8,572,454 | $ | 7,937,323 | 635,131 | 8.0 | ||||||||||
|
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|
• | increases in headcount, medical and regulatory affairs and quality assurance expenses and expenses from our ongoing clinical trials evaluating Firdapse ® for the treatment of MuSK-MG, and our proof-of-concept ® for the treatment of SMA Type 3; and |
• | increases in employee stock-based compensation which is non-cash and relates to the expense of stock options awards to certain employees, due to increase in headcount. |
Three months ended June 30, |
Change |
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2020 |
2019 |
$ |
% |
|||||||||||||
Selling |
$ | 5,621,780 | $ | 4,881,137 | 740,643 | 15.2 | ||||||||||
General and administrative |
3,838,336 | 3,454,801 | 383,535 | 11.1 | ||||||||||||
Employee stock-based compensation |
1,373,242 | 651,784 | 721,458 | 110.7 | ||||||||||||
|
|
|
|
|
|
|
|
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Total selling, general and administrative expenses |
$ | 10,833,358 | $ | 8,987,722 | 1,845,636 | 20.5 | ||||||||||
|
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|
|
|
Six months ended June 30, |
Change |
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2020 |
2019 |
$ |
% |
|||||||||||||
Selling |
$ | 11,425,925 | $ | 9,985,045 | 1,440,880 | 14.4 | ||||||||||
General and administrative |
6,995,941 | 6,121,663 | 874,278 | 14.3 | ||||||||||||
Employee stock-based compensation |
2,474,540 | 1,297,474 | 1,177,066 | 90.7 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total selling, general and administrative expenses |
$ | 20,896,406 | $ | 17,404,182 | 3,492,224 | 20.1 | ||||||||||
|
|
|
|
|
|
|
|
• | increases in selling (commercialization) expenses, which consist primarily of the costs of our expansion of the sales force and the cost of contracting with a rare-disease experience inside sales agency; |
• | increases in general and administrative expenses, which are primarily due to the expansion of our operations and headcount to support our ongoing efforts to expand our net revenues from sales of Firdapse ® ; and |
• | increases in employee stock-based compensation which is non-cash and relates to the expense of stock options awards to certain employees and directors due to increase in headcount. |
• | the scope, rate of progress and cost of our clinical trials and other product development activities; |
• | future clinical trial results; |
• | the terms and timing of any collaborative, licensing and other arrangements that we may establish; |
• | the cost and timing of regulatory approvals; |
• | the cost and delays in product development as a result of any changes in regulatory oversight applicable to our products; |
• | the level of revenues that we report from sales of Firdapse ® ; |
• | the effect of competition and market developments; |
• | the cost of filing and potentially prosecuting, defending and enforcing any patent claims and other intellectual property rights; and |
• | the extent to which we acquire or invest in other products. |
• | Payments under our license agreement ® equal to 7% of net sales (as defined in the license agreement) in North America for any calendar year for sales up to $100 million, and 10% of net sales in North America in any calendar year in excess of $100 million; and (ii) royalties to the third-party licensor of the rights sublicensed to us for seven years from the first commercial sale of Firdapse® equal to 7% of net sales (as defined in the license agreement between BioMarin and the third-party licensor) in any calendar year. For the three and six-months ended June 30, 2020, we recognized approximately $3.9 million and $7.8 million, respectively, of royalties, which is included in cost of sales in the accompanying consolidated statement of operations. |
• | Purchase commitments |
• | Employment agreements |
• | Lease for office space |
• | The impact of the recent outbreak of a novel strain of coronavirus on our business or on the economy generally; |
• | Whether we will be able to continue successfully market Firdapse ® while maintaining full compliance with applicable federal and state laws, rules and regulations; |
• | Whether our estimates of the size of the market for Firdapse ® for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) will turn out to be accurate; |
• | Whether we will be able to locate LEMS patients who are undiagnosed or are misdiagnosed with other diseases; |
• | Whether patients will discontinue from the use of our drug at rates that are higher than historically experienced or are higher than we project; |
• | If the average daily dose taken by patients changes over time, it could affect our results of operations; |
• | Whether Firdapse ® patients can be successfully titrated to stable therapy; |
• | Whether we can continue to market Firdapse ® on a profitable and cash flow positive basis; |
• | Whether any revenue guidance that we provide to the public market will turn out to be accurate; |
• | Whether payors will continue to reimburse for our product at the price that we charge for the product; |
• | The ability of our third-party suppliers and contract manufacturers to maintain compliance with current Good Manufacturing Practices (cGMP); |
• | The ability of our distributor and the specialty pharmacies that distribute our product to maintain compliance with applicable law; |
• | Our ability to maintain compliance with applicable rules relating to our patient assistance programs and our contributions to 501(c)(3) organizations that support LEMS patients; |
• | The scope of our intellectual property and the outcome of any future challenges or opposition to our intellectual property, and, conversely, whether any third-party intellectual property presents unanticipated obstacles for Firdapse ® ; |
• | The effect on our business and future results of operations arising from the approval by the FDA of Ruzurgi ® for the treatment of pediatric LEMS patients (ages 6 to under 17); |
• | Whether our suit against the United States FDA seeking to vacate the FDA’s approval of Ruzurgi ® will be successful; |
• | Whether we can continue to compete successfully if the approval of Ruzurgi ® is not overturned and Ruzurgi® continues to be prescribed for off-label use by adult LEMS patients; |
• | Whether, because of the lower price of Ruzurgi ® , payors will require that patients try off-label Ruzurgi® first before they approve Firdapse® as a treatment for adult LEMS patients; |
• | The impact on Firdapse ® of adverse changes in potential reimbursement and coverage policies from government and private payors such as Medicare, Medicaid, insurance companies, health maintenance organizations and other plan administrators, or the impact of pricing pressures enacted by industry organization, the federal government or the government of any state, including as a result of increased scrutiny over pharmaceutical pricing or otherwise; |
• | The impact on our business and results of operations of public statements by politicians and a vocal group of LEMS patients and doctors who object to our pricing of Firdapse ® ; |
• | Changes in the healthcare industry and the effect of political pressure from and actions by President Trump, Congress and/or medical professionals seeking to reduce prescription drug costs; |
• | The state of the economy generally and its impact on our business; |
• | Changes to the healthcare industry occasioned by any future repeal and replacement of the Affordable Care Act, in laws relating to the pricing of drug products, or changes in the healthcare industry generally; |
• | The scope, rate of progress and expense of our clinical trials and studies, pre-clinical studies, proof-of-concept |
• | Our ability to complete our trials and studies on a timely basis and within the budgets we establish for such trials and studies; |
• | Whether the recent coronavirus outbreak will further affect the timing of our currently ongoing clinical trials; |
• | Whether the trial that we are currently undertaking to evaluate Firdapse ® for the treatment of Spinal Muscular Atrophy (SMA) Type 3, or any other trials that we may undertake in the future, will be successful; |
• | Whether Firdapse ® will ever be approved for the treatment of MuSK-MG, SMA Type 3, or any other neuromuscular disease; |
• | Whether we can successfully commercialize Firdapse ® in Canada on a profitable basis; |
• | The impact on sales of Firdapse ® in the United States if an amifampridine product is purchased in Canada for use in the United States; |
• | Whether we will be able to successfully complete the clinical trial in Japan that will be required to seek approval to commercialize Firdapse ® in Japan; |
• | Whether we will be able to obtain approval to commercialize Firdapse ® in Japan; |
• | Whether we can successfully develop, obtain approval of and successfully market a sustained release version of Firdapse ® ; |
• | Whether our efforts to grow our business beyond Firdapse ® through acquisitions of companies or in-licensing of product opportunities in the neuromuscular or neurology therapeutic areas will be successful; |
• | Whether we will have sufficient capital to finance any such acquisitions; |
• | Whether our version of generic vigabatrin tablets will ever be approved by the FDA; |
• | Even if our version of vigabatrin tablets is approved for commercialization, whether Endo Ventures/Par Pharmaceutical (our collaborator in this venture) will be successful in marketing the product; and |
• | Whether we will earn milestone payments on the first commercial sale of vigabatrin tablets and royalties on sales of generic vigabatrin tablets. |
a. |
We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on such evaluation, our principal executive officer and principal financial officer have concluded that as of June 30, 2020, our disclosure controls and procedures were effective to ensure that the information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act, was recorded, processed, summarized or reported within the time periods specified in the rules and regulations of the SEC, and include controls and procedures designed to ensure that information required to be disclosed by us in such reports was accumulated and communicated to management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures. |
b. |
During the three months ended June 30, 2020, there were no changes in our internal controls or in other factors that could have a material effect, or are reasonably likely to have a material effect, on our internal control over financial reporting. |
31.1 | Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002 | |
31.2 | Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002 | |
32.1 | Certification of Principal Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2 | Certification of Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 | |
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 Taxonomy Extension Schema Document | |
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | The cover page for the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, has been formatted in Inline XBRL. |
Catalyst Pharmaceuticals, Inc. | ||
By: | /s/ Alicia Grande | |
Alicia Grande | ||
Vice President, Treasurer and Chief Financial Officer |
Exhibit 31.1
Certification of Principal Executive Officer
I, Patrick J. McEnany, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Catalyst Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this quarterly 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 registrants 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 15(d)-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 subsidiary, 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants 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 registrants 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 registrants internal control over financial reporting. |
Date: August 10, 2020
/s/ Patrick J. McEnany |
Patrick J. McEnany |
Chief Executive Officer |
(Principal Executive Officer) |
Exhibit 31.2
Certification of Principal Financial Officer
I, Alicia Grande, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Catalyst Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this quarterly 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 registrants 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 15(d)-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 subsidiary, 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants 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 registrants 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 registrants internal control over financial reporting. |
Date: August 10, 2020
/s/ Alicia Grande |
Alicia Grande |
Chief Financial Officer |
(Principal Financial Officer) |
Exhibit 32.1
Certification Required by 18 U.S.C. Section 1350
(as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002)
I, Patrick J. McEnany as Principal Executive Officer of Catalyst Pharmaceuticals, Inc. (the Company), certify, pursuant to 18 U.S.C. Section 1350 (as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002), that to my knowledge:
1. | the accompanying Quarterly Report on Form 10-Q of the Company for the quarterly period ended June 30, 2020 (the Report), filed with the U.S. Securities and Exchange Commission, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: August 10, 2020 | /s/ Patrick J. McEnany | |||||
Patrick J. McEnany | ||||||
Chief Executive Officer | ||||||
(Principal Executive Officer) |
Exhibit 32.2
Certification Required by 18 U.S.C. Section 1350
(as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002)
I, Alicia Grande as Principal Financial Officer of Catalyst Pharmaceuticals, Inc. (the Company), certify, pursuant to 18 U.S.C. Section 1350 (as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002), that to my knowledge:
1. | the accompanying Quarterly Report on Form 10-Q of the Company for the quarterly period ended June 30, 2020 (the Report), filed with the U.S. Securities and Exchange Commission, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: August 10, 2020 | /s/ Alicia Grande | |||||
Alicia Grande | ||||||
Chief Financial Officer | ||||||
(Principal Financial Officer) |